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Module Levels for Modular Categories

Minor, non-technical variation to label and/or product details, required by the APVMA.

1.   EXPLANATION OF THE MODULES

1.1.   Introduction

Schedule 6 of the Agvet Regulations provides a definition of the categories under which applications may be made for:

• approval of a new active constituent
• registration of an agricultural or veterinary product
• approval of an agricultural or veterinary product label
• variation of the particulars or conditions of approval of an approved active constituent
• variation of the particulars or conditions of product registration
• variation of the particulars or conditions of label approval
• issue of a permit
• any other assessment of a technical nature.

There are 25 application categories. Of these, 18 have a fixed application fee and assessment period which is provided in Schedule 6.

Seven of the categories are modular (Categories 2, 10, 14, 21, 23, 24 and 25). The fee and assessment period for these categories will depend on which modules are required to enable assessment of the application. The modules, their fees and assessment periods are provided in Schedule 7 of the Agvet Regulations.

The modules relate to screening; chemistry and manufacture; toxicology; residues; occupational health & safety (OH&S); environment; efficacy and host crop safety; non-food trade assessment; special data; finalisation; and data protection.

Modular application categories reflect the different levels of hazard for in different types of applications. These different levels of hazard require different levels of assessment.

Schedule 7 provides that with the exception of module items 1, 4, 9 and 12, each module is divided into a number of levels. For example a Chemistry assessment can be comprehensive (level 1), reduced (level 2), reduced (level 3) or limited (level 4). Each level has a corresponding assessment period and assessment fee.

Reference to the relevant sections of this document ‘Module levels for modular categories’, will allow an applicant to determine what data packages are required for each module required for assessment of an application which fits into a modular application category.

Modules are also relevant for fixed application categories, because the data packages for the different data Parts also are linked to modules. By referring to the relevant application category chapter in Volume 2, Category requirements and guidelines, an applicant can determine what data packages are required for a fixed application category.

1.2.    Relationship of this document to the Legislative Instrument in Volume 1

This document interfaces with the Legislative Instrument in Volume 1, ‘Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Fees Assessment) 2005’, which describes application types that require assessment under the various levels and types of modules in Schedule 7 of the Agvet Regulations. This document ‘Module levels for modular categories’ provides applicants with information not contained in the Legislative Instrument, on the data packages that are required for the different application types.

The Legislative Instrument also provides for a reduced or limited assessment (under Modules 2.2, 2.4, 3.3, 5.4, 6.3, 7.3 or 8.3) of application types that are not otherwise described.

Where there is any dispute as to the module assessment level required for a type of application, the Legislative Instrument is the authoritative document.

1.3.    Fee and timeframe

The applicable fee and timeframe for assessment by the APVMA may be found in Schedule 7 of the Agvet Regulations (see Module fees).

The total fee for assessing an application can be determined by totalling the fees payable for all the modules necessary to evaluate the application.

Note that although the timeframe for an application for a minor use permit under Category 21 is a modular assessment period, the fee for this application is fixed at $350.

The timeframe can be determined by taking whichever module timeframe is the longest, and adding it to the relevant finalisation module.

1.4.    Assessment of applications to the APVMA

The assessment of applications for approval of active constituents, registration of products and approval of their labels, the issue of a permit, or variations of existing approval and registrations, is conducted within a legislative framework.

Section 14 of the Agvet Code provides that the APVMA must grant an application for approval of an active constituent, or registration of a chemical product, or approval of a label for containers for a chemical product if (amongst other things) the AVPMA is satisfied that the use of the active constituent or product in accordance with its instructions for use:

• would not be an undue hazard to the safety of people exposed to it during its handling, or people using anything containing its residues; and
• would not be likely to have an effect that is harmful to human beings; and
• would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and
• would not unduly prejudice trade or commerce between Australia and places outside Australia; and
• that if the application is for a chemical product, use of the product would be effective when used in accordance with label instructions.

Section 29 of the Agvet Code provides for applications for variation of relevant particulars, or of conditions of approval, or registration, which may have been granted under s.14.

During assessment of applications the APVMA seeks the advice of other government agencies or expert individual reviewers, in order to assist in determining whether the APVMA is satisfied that an application meets the criteria prescribed by the Agvet Code. A final technical evaluation and risk assessment is conducted by the APVMA before an authorised delegate makes a decision to grant or refuse an application.

1.5.    Modular assessments

1.5.1.      Introduction

When an application falls into one of the modular categories (2, 10, 14, 21, 23, 24 or 25) it is subject to assessment under several or all of the technical module items: chemistry and manufacture; toxicology; residues; OH&S; environment; efficacy and host crop safety; non-food trade; and special data.

All applications are subject to screening (Module 1) and finalisation (Module 11.1-11.4) and, where studies have been provided which require technical assessment, data protection (Module 12).

The tables commencing in section 3 of this document outline the types of applications in relation to which an assessment of chemistry and manufacture; toxicology; residues; OH&S; environment; efficacy and host crop safety; non-food trade; and special data, will be required to allow the APVMA to finalise an application. If an application is of a type described in the first column, an assessment of data packages specified in the second column will be required.

When searching for a description of the type of application it is important to read the entire table section for the particular module in order to characterise the application. For example, when searching for the appropriate Chemistry module for a new agricultural product with a new active constituent, the product at first may seem to be assessed under Chemistry module 2.1. However, if the active constituent is used in a household or industrial chemical, it would qualify for assessment under Chemistry module 2.2.

1.5.2.      Screening (Module 1)

Applications normally undergo up to three levels of screening before they are accepted for evaluation by the APVMA:

administrative screening:	assesses that the application has been made in the correct form and that the required fees have been paid;
technical screening:	assesses that all the data which are required for an application have been submitted;
agency screening:	assesses whether all of the required data have been submitted to allow the Commonwealth agencies, which provide advice relevant to toxicology, OH&S, and environment, to evaluate the application.

The screening module does not have levels.

1.5.3.      Chemistry (Modules 2.1, 2.2, 2.3, 2.4)

The APVMA’s Chemistry and Residues Program normally conducts assessments of chemistry data in order to determine the quality of the product and its active constituent.

Chemistry refers to assessment of applications for registration or variation with respect to the chemistry aspects of s.14(4) and s.14(5) of the Agvet Code. These are the chemistry aspects of:

• the active constituent
• the formulated product
• manufacturing process
• quality control, specifications
• batch analysis
• storage stability
• analytical methods
• packaging and labelling

Schedule 7 to the Agvet Regulations provides four levels for module 2 (Chemistry). The module level required for Chemistry assessment of an application will be determined by the nature of the application as described in section 3 of this document.

1.5.4.      Toxicology (Modules 3.1, 3.2, 3.3)

The Office of Chemical Safety (OCS) within the Department of Health and Ageing (DoHA) normally provides advice to the APVMA on toxicology aspects of applications.

Toxicology refers to assessment of:

• applications for approval of active constituents or registration of products with respect to the toxicological aspects of s.14(3), s.14(4) and s.14(5) of the Agvet Code
• applications for variation of approval or registration with respect to the toxicological aspects of s.29(1) of the Agvet Code
• applications for issue of a permit under s.112(2) of the Agvet Code.

The toxicology evaluation considers whether an acceptable daily intake (ADI) and acute reference dose (ARfD) have been established for the active constituent. If they have not been set and the use-pattern of the product requires that they be set, an ADI and ARfD are set. If an ADI and ARfD have already been set, the application is considered against these values and a decision is made whether they should be retained or amended.

The toxicology evaluation includes:

• kinetics and metabolism studies
• short-term studies
• sub-chronic studies
• chronic studies
• reproduction studies
• developmental studies
• genotoxicity studies
• additional relevant studies
• hazard characterisation
• ADI and ARfD considerations
• Poisons Schedule considerations.

Schedule 7 to the Agvet Regulations provides three levels for module 3 (Toxicology). The module level required for Toxicology assessment of an application will be determined by the nature of the application as described in section 3 of this document.

Application types which do not routinely require toxicological assessment

The following applications will not routinely be submitted to OCS for toxicological evaluation:

• small scale trial permits under permit 7250.

1.5.5.      Scheduling (Module 4)

This is an additional module that applies to any application for either an agricultural or veterinary chemical, where the application must be referred to the NDPSC for Poisons Scheduling, as required under Toxicology modules 3.1, 3.2 or 3.3.

Data requirements are covered by the Toxicology modules.

1.5.6.      Residues (Modules 5.1, 5.2, 5.3, 5.4, 5.5)

Assessments of residues data are normally conducted by the APVMA’s Chemistry and Residues Program.

Residues refers to assessment of applications for registration or variation with respect to the residues aspects of s.14(3)(e)(i), s.14(3)(e)(iv) and s.14(5) of the Agvet Code, or of s.112(2) for permit applications.

The residues assessment includes:

• establishment of residue definition, maximum residue limits (MRLs), and withholding periods (WHPs);
• trade implications of the application, including an export interval (EI).

Schedule 7 to the Agvet Regulations provides five levels for module 5 (Residues). The module level required for Residues assessment of an application will be determined by the nature of the application as described in sections 3 and 4 of this document.

1.5.7.      Occupational Health and Safety [OH&S] (Modules 6.1, 6.2, 6.3)

The OCS normally provides advice to the APVMA on OH&S aspects of applications.

OH&S refers to assessment of applications for registration with respect to the occupational health and safety aspects of s.14(3) and s.14(5) of the Agvet Code, or of s.29(1) for variations, or of s.112(2) for permit applications.

Schedule 7 to the Agvet Regulations provides three levels for module 6 (OH&S). The module level required for the OH&S assessment of an application will be determined by the nature of the application as described in section 3 of this document.

Application types which do not routinely require OH&S assessment

The following applications will not routinely be submitted to OCS for OH&S assessment:

• products to be used by the householder in the home and home garden
• agricultural applications for research permits, excluding new application method or new use situation (existing active constituents) for use by all persons
• microbial products where all the microbial active constituents are approved.

1.5.8.      Environment (Modules 7.1, 7.2, 7.3)

The Department of the Environment and Heritage (DEH) normally provides advice to the APVMA on environmental aspects of applications.

Environment refers to assessment of applications for registration with respect to the environmental aspects of s.14(3) and s.14(5) of the Agvet Code, or of s.29(1) for variations, or of s.112(2) for permit applications.

Schedule 7 to the Agvet Regulations provides three levels for module 7 (Environment). The module level required for environmental assessment of an application will be determined by the nature of the application as described in sections 3 and 4 of this document.

1.5.9.      Efficacy and Host Crop Safety (Modules 8.1, 8.2, 8.3)

Evaluations of efficacy and host crop safety are conducted by either expert reviewers external to the APVMA, or by APVMA reviewers.

Efficacy and host crop safety refers to assessment of applications for registration with respect to the efficacy and safety aspects of s.14(3), s.14(5) and s.14(6) of the Agvet Code, or of s.29(1) for variations, or of s.112(2) for permit applications.

The efficacy and host crop safety assessment includes:

• assessment of the results of experimental trials for efficacy and safety
• effect on following crops or non-target crops
• organoleptic tests
• effects of residues on subsequent processing of crops;
• safety to non-target crops
• pharmacologic studies
• compatibility studies.

Schedule 7 to the Agvet Regulations provides three levels for module 8 (Efficacy and Safety). The module level required for Efficacy and Host Crop Safety assessment of an application will be determined by the nature of the application as described in sections 3 and 4 of this document.

1.5.10.    Non-food trade (Module 9)

This module covers an application that requires assessment of trade risk relating to non-food residue situations e.g. residues in wool and fibre, presence of disease or seropositive testing to exotic or notifiable agents, hormonal growth promotants and other endocrine substances, or genetically-modified produce.

The non-food trade module does not have levels.

1.5.11.    Special data (Modules 10.1, 10.2, 10.3)

There are two principal types of applications for approval of active constituents or registration of products which require the submission of special data:

1. 1. New antibiotic products

   The APVMA seeks advice from the Expert Advisory Group on Antimicrobial Resistance (EAGAR) on these types of applications.

   EAGAR is an expert committee of the National Health and Medical Research Council and was established as a consequence of government’s acceptance of the recommendations of the 1999 report of the Joint Expert Technical Advisory Committee on Antibiotic Resistance (JETACAR). The role of EAGAR is to review antibiotic risk assessments conducted by the applicant or APVMA.
   
   

   EAGAR’s review of the risk assessment includes:

   • use patterns of the antibiotic in human medicine
   • risk of the emergence of bacterial antibiotic resistance
   • risk of transfer of bacterial antibiotic resistance into human pathogens due to agricultural or veterinary use.



2. 2. Genetically-modified organisms (GMOs)

   The Gene Technology Act 2000, which came into force on 21 June 2001, introduces a national scheme for the regulation of GMOs in Australia. This is in order to protect the health and safety of Australians and the Australian environment by identifying risks posed by, or as a result of gene technology, and to manage those risks by regulating certain dealings with GMOs.

   The Office of the Gene Technology Regulator (OGTR) has been established within DoHA to provide scientific and administrative support to implementation of the Gene Technology Act 2000.
   The APVMA seeks advice from the OGTR on these applications which involve GMOs in accordance with paragraph 14(3)(ca) of the Agvet Code and paragraph 8A(2)(a) of the Agricultural and Veterinary Chemicals (Administration) Act 1992.
   OGTR’s assessment identifies any risks to people or the environment posed by, or as a result of gene technology.

Schedule 7 to the Agvet Regulations provides three levels for module 10 (special data). The module level required for Special Data assessment of an application will be determined by the nature of the application as described in section 3 of this document.

Modules 10.1 and 10.2 relate specifically to antibiotic resistance.

Module 10.3 relates to GMOs and any other application which requires assessment of special data.

1.5.12.    Finalisation (Modules 11.1, 11.2, 11.3, 11.4)

This module encompasses administrative and technical steps in public consultation and finalisation of applications. There are no data requirements associated with the finalisation module.

Schedule 7 to the Agvet Regulations provides four levels for module 11. The module level for an application will be determined by the number of other modules which are required for an application as summarised below:

Module	Type of application
Module 11.1	a product registration or variation or permit application which requires three or more modular assessments (modules 2.1 to 10.3, excluding 2.4)
Module 11.2	a product registration or variation application which requires one or two modular assessments (modules 2.1 to 10.3)
Module 11.3	a permit application which requires one or two modular assessments (modules 2.1 to 10.3)
Module 11.4	any minor application requiring no technical assessment or technical assessment with only module 2.4

1.5.13.    Data Protection (Module 12)

This module covers administrative and technical steps in assigning protection to relevant data.

The data protection module has only a single level.

2.    OUTLINE OF MODULE APPLICATION TYPES

Module 2.1      Chemistry

Type of application:

1. New product with new active constituent, or new active constituent only (unless included in Module 2.2)

Module 2.2      Chemistry

Type of application:

1. New biological product with new active constituent, or new active constituent only (except those described in Module 2.1)
2. New product with new active constituent which is used in household or industrial chemicals, or new active constituent only
3. New product with new source of existing active constituent, or new source of active constituent only
4. Permit, new active constituent
5. New product where the active constituent has been previously assessed under permit

Module 2.3      Chemistry

Type of application:

1. New product with existing active constituent

Module 2.4      Chemistry

Type of application:

1. Variations to chemistry and manufacture details of registered agricultural chemical products
2. Extension of shelf life
3. Extension of in-use shelf life
4. Change to storage temperature / conditions
5. Change to packaging material (immediate container and/or closure system)
6. Other applications where assessment of only stability data ± product specifications may be required
7. Permit application – where minor chemistry assessment is required

Module 3.1      Toxicology

Type of application:

1. New product with new active constituent, or new active constituent only (unless included in Module 3.2 or 3.3)
2. Permit application for a new active constituent (unless included in Module 3.2 or 3.3)

Module 3.2      Toxicology

Type of application:

1. New product / permit, new active constituent, for non-food-producing use
2. Research permit, new active constituent, food-producing use, with restrictions (single season / single use / specified research personnel)
3. New product / product variation / permit, existing active constituent – extension of use from non-food-producing to food-producing use for the first time for the active constituent (ADI ± ARfD required)

Module 3.3      Toxicology

Type of application:

1. New product / permit, existing active constituent – new formulation or major change in formulation
2. New biological chemical product containing new active constituent, adjuvant or excipient
3. New product / product variation, existing active constituent – extension from commercial use to use by a householder in the home / home garden
4. Label variation – change to safety directions (hazard statements) and / or change to label first aid statements and / or poison scheduling
5. Research permit, new active constituent, for non-food-producing use, with restrictions (single season / single use / specified research personnel)
6. New product / permit, new active constituent, where an overseas report or health assessment report has been supplied

Module 4         Scheduling

This is an additional module that applies to any application for either an agricultural or veterinary chemical, where the application must be referred to the NDPSC for poisons scheduling.

Data requirements are covered by Toxicology modules 3.1, 3.2 or 3.3.

Module 5.1      Residues

Type of application:

1. New product, new active constituent, for use in food crop
2. New product / product variation, existing active constituent – extension of use to food crop from non-food plant for the first time for the active constituent
3. Permit, new active constituent – use in food crop

Module 5.2      Residues

Type of application:

1. New product / product variation, existing active constituent – extension to or use in a major food crop
2. Major formulation change
3. New product / product variation, existing active constituent – major change in use pattern

Module 5.3      Residues

Type of application:

1. Permit, existing active constituent – use in new food crop

Module 5.4      Residues

Type of application:

1. New product / product variation, existing active constituent – extension to or use in a non-major food crop
2. Label variation with potential residue risks

Module 5.5      Residues

Type of application:

1. Permit application, existing active constituent – minor use, emergency use or research permit for a food crop

Module 6.1      Occupational Health & Safety

Type of application:

1. New product, new active constituent, including biological chemical product

Module 6.2      Occupational Health & Safety

Type of application:

1. Permit for use by all persons of a formulation containing a new active constituent
2. New product, existing active constituent – major formulation change
3. New product / product variation, existing active constituent – involving new crop group / new situation and / or new application method

Module 6.3      Occupational Health & Safety

Type of application:

1. Permit, existing active constituent – new application method or new use situation, for use by all persons
2. Label variation – change / reassessment of user Safety Directions and / or re-entry or re-handling statements

Module 7.1      Environment

Type of application:

1. New product, new active constituent
2. New product, new combination of existing active constituents – extension of use to new crop, new situation

Module 7.2      Environment

Type of application:

1. New product / product variation, existing active constituent – extension of use to new crop or new situation
2. New product / product variation – major formulation change or increased application rate
3. Product variation – extension to aerial use
4. Product containing new active constituent for use under permit

Module 7.3      Environment

Type of application:

1. New product / product variation, (excluding all vertebrate poisons), new or existing active constituents, where the product is for use by the householder in the home / home garden / swimming pool / spa; or in buildings not used in animal production (e.g. warehouses, offices, glasshouses); or as a treatment for stored produce or goods; or as a post-harvest application to any crop
2. Label variation – change to environmental instructions and warnings
3. Product containing existing active constituent for use under permit

Module 8.1      Efficacy & Host Crop Safety

Type of application:

1. New product containing new active constituent or new combination of existing active constituents or significant new formulation not included in module 8.2
2. New or existing product, existing active constituent, for use in a new crop group / situation and / or for the control of new pests

Module 8.2      Efficacy & Host Crop Safety

Type of application:

1. Existing product – extension of use to a new host or a new pest within the same crop group / situation and with the same general use pattern
2. New or existing product, existing active constituent – new household / home garden use; extension to a minor use for new pests where the use and pests are closely similar to an existing use pattern; significant new formulation / change in use pattern requiring reduced assessment of both efficacy and safety

Module 8.3      Efficacy & Host Crop Safety

Type of application:

1. New product where efficacy and safety data are required to demonstrate similarity to an existing registered product
2. Label or formulation changes that are expected to have a minor impact on efficacy or crop safety
3. Extension to a minor use within the same crop group / situation for an existing pest and application rate
4. Permit application – minor use in a new crop / situation

Module 9         Non-Food Trade

Type of application:

1. Agricultural chemicals involving trade risks not related to food residues, including genetically-modified produce

Module 10.3    GM organism / other special data

Type of application:

1. Any application requiring an assessment of special data such as assessment of a product containing a genetically-modified organism (GMO)

3.    MODULE DATA REQUIREMENTS

Module 2.1      Chemistry

MODULE 2.1    CHEMISTRY
Type of application	Data required
New product with new active constituent1, or new active constituent only (unless included in Module 2.2) Footnote 1: Active constituents where a full chemistry assessment is required: A full chemistry assessment is expected to be required for products that contain a new active constituent which meets any of the following criteria: active constituent manufactured by chemical synthesis; highly purified and well-characterised active constituent derived from plants or animals; semi-synthetic active constituent manufactured by the chemical modification of a highly purified and well-characterised intermediate derived from plants or animals; semi-synthetic active constituent manufactured by the chemical modification of an intermediate produced by conventional fermentation; active constituent produced by conventional fermentation or using recombinant DNA technology; active constituent produced by transgenic technology; growth regulators, antibiotics and polypeptides; some animal tissue extracts and some plant extracts/oils.	A Chemistry data package for comprehensive assessment requires submission of all of the following data, or submission of valid scientific argument not to submit certain data: Active constituent identification (common name, chemical name, molecular and structural formula, spectral data, physical and chemical properties); stability data; manufacturer and site of manufacture; manufacturing process (including quality control, impurities); declaration of composition (specifications); batch analysis data; analytical methods; validation data; analytical reference standards; packaging Product active constituent standard; product details: distinguishing name; formulation type; formulator and site of formulation; formulation composition; non-active constituent specifications; manufacturing process (including quality control); physical and chemical properties; product specifications; batch analysis data; stability data; in-use stability data (where relevant); analytical methods; validation data; packaging; draft label Detailed data requirements are in Part 2

Module 2.2      Chemistry

MODULE 2.2    CHEMISTRY
Type of application	Data required
New biological product with new active constituent, or new active constituent only (except those described in Module 2.11) New product with new active constituent which is used in household or industrial chemicals2 , or new active constituent only Footnote 2: Active constituents in household / industrial chemicals Certain solvents, surfactants and oils used to dilute or spread other agricultural chemicals, some disinfectants, and biocides used to control moulds and fungi in agriculture, may also be commonly-used household or industrial chemicals. If these chemicals are well known, in common use and have a history of safety in the context of use, they may qualify for reduced chemistry assessment.	A Chemistry data package for reduced assessment requires submission of all of the following data, or submission of valid scientific argument not to submit certain data: Active constituent identification (common name, chemical name, molecular and structural formula, spectral data, physical and chemical properties); information on active constituent consisting of or derived from GMOs (where relevant); stability data; manufacturer and site of manufacture; manufacturing process (including quality control, impurities); declaration of composition (specifications); batch analysis data; analytical methods; validation data; packaging Product active constituent standard; product details: distinguishing name; formulation type; formulator and site of formulation; formulation composition; non-active constituent specifications; manufacturing process (including quality control); physical and chemical properties; product specifications; batch analysis data; stability data; in-use stability data (where relevant); analytical methods; validation data; packaging; draft label Detailed data requirements are in Part 2
MODULE 2.2    CHEMISTRY
Type of application	Data required
New product with new source of existing active constituent, or new source of active constituent only	Active constituent identification (common name, chemical name, molecular and structural formula, spectral data); information on active constituent consisting of or derived from GMOs (where relevant); manufacturer and site of manufacture; manufacturing process (including quality control, impurities); declaration of composition (specifications); batch analysis data; analytical methods; validation data Product active constituent standard; product details: distinguishing name; formulation type; formulator and site of formulation; formulation composition; non-active constituent specifications; manufacturing process (including quality control); physical and chemical properties; product specifications; batch analysis data; stability data; in-use stability data (where relevant); analytical methods; validation data; packaging; draft label Detailed data requirements are in Part 2
MODULE 2.2    CHEMISTRY
Type of application	Data required
Permit, new active constituent New product where the active constituent has been previously assessed under permit	Active constituent identification (common name, chemical name, molecular and structural formula, spectral data, physical and chemical properties); stability data; manufacturer and site of manufacture; manufacturing process (including quality control, impurities); declaration of composition (specifications); batch analysis data; analytical methods; validation data; analytical reference standards; packaging Product active constituent standard; product details: distinguishing name; formulation type; formulator and site of formulation; formulation composition; non-active constituent specifications; manufacturing process (including quality control); physical and chemical properties; product specifications; batch analysis data; stability data; in-use stability data (where relevant); analytical methods; validation data; packaging; draft label Detailed data requirements are in Part 2

Module 2.3      Chemistry

MODULE 2.3    CHEMISTRY
Type of application	Data required
New product with existing active constituent	A Chemistry data package for product-only assessment requires submission of all of the following data, or submission of valid scientific argument not to submit certain data: Product active constituent standard; product details: distinguishing name; formulation type; formulator and site of formulation; formulation composition; non-active constituent specifications; manufacturing process (including quality control); physical and chemical properties; product specifications; batch analysis data; stability data; in-use stability data (where relevant); analytical methods; validation data; packaging; draft label Detailed data requirements are in Part 2

Module 2.4      Chemistry

MODULE 2.4    CHEMISTRY
Type of application	Data required
Variations to chemistry and manufacture details of registered agricultural chemical products including: minor formulation change requiring technical assessment; change to product specifications with or without a change in manufacturing process; change to non-active constituent specifications requiring technical assessment	A Chemistry data package for limited assessment requires submission of all of the following data, or submission of valid scientific argument not to submit certain data: Product product details: distinguishing name; formulation type; formulator and site of formulation; formulation composition; non-active constituent specifications; manufacturing process (including quality control); physical and chemical properties; product specifications; batch analysis data; stability data; analytical methods; validation data Detailed data requirements are in Part 2
MODULE 2.4    CHEMISTRY
Type of application	Data required
Extension of shelf life Extension of in-use shelf life Change to storage temperature / conditions Change to packaging material (immediate container and/or closure system) Other applications where assessment of only stability data ± product specifications may be required	Product product details: distinguishing name; formulation type; product specifications; stability data; in-use stability data (where relevant); analytical methods; validation data; packaging; draft label (where relevant) Detailed data requirements are in Part 2
MODULE 2.4    CHEMISTRY
Type of application	Data required
Permit application – where minor chemistry assessment is required	Product product specifications; batch analysis data; stability data; analytical methods; validation data; draft oversticker / label Detailed data requirements are in Part 2

Module 3.1      Toxicology

MODULE 3.1    TOXICOLOGY
Type of application	Data required
New product with new active constituent, or new active constituent only (unless included in Module 3.2 or 3.3) Permit application for a new active constituent (unless included in Module 3.2 or 3.3)	A Toxicology data package for comprehensive assessment requires submission of all of the following studies, or submission of valid scientific argument not to submit certain studies: chemistry and manufacture (data Part 2); toxicokinetics and metabolism (data Part 4); acute toxicity studies: studies on the active constituent; studies on the product; short-term toxicity studies (repeat-dose studies of less than 90 days duration); sub-chronic toxicity studies (90 days to less than 12 months); long-term (chronic) toxicity studies (12 months or longer): carcinogenicity studies; chronic toxicity and/or carcinogenicity studies; reproduction studies; developmental (teratology) studies; genotoxicity studies additional studies toxicity of metabolites and impurities; other adverse effects; toxicity of mixtures; human toxicological data; no-observed-effect level (NOEL); acceptable daily intake (ADI); acute reference dose (ARfD); first aid instructions and safety directions; toxicological database Detailed data requirements are in Part 3

Module 3.2      Toxicology

MODULE 3.2    TOXICOLOGY
Type of application	Data required
New product / permit, new active constituent, for non-food-producing use Research permit, new active constituent, for food-producing use, with restrictions (single season / single use / specified research personnel)	A Toxicology data package for reduced assessment requires submission of all of the following studies, or submission of valid scientific argument not to submit certain studies: chemistry and manufacture (data Part 2); toxicokinetics and metabolism (data Part 4); acute toxicity studies: studies on the active constituent; studies on the product; short-term toxicity studies (repeat-dose studies of less than 90 days duration); sub-chronic toxicity studies (90 days to less than 12 months); developmental (teratology) studies; genotoxicity studies additional studies toxicity of metabolites and impurities; other adverse effects; toxicity of mixtures; human toxicological data; no-observed-effect level (NOEL); first aid instructions and safety directions; toxicological database Detailed data requirements are in Part 3
MODULE 3.2    TOXICOLOGY
Type of application	Data required
New product / product variation / permit, existing active constituent – extension of use from non-food-producing to food-producing use for the first time for the active constituent (ADI ± ARfD required)	In addition to submission of all of the studies above, or submission of valid scientific argument not to submit some of the studies above, the following data are required: long-term (chronic) toxicity studies (12 months or longer): carcinogenicity studies; chronic toxicity and/or carcinogenicity studies; reproduction studies; acceptable daily intake (ADI); acute reference dose (ARfD) Detailed data requirements are in Part 3

Module 3.3      Toxicology

MODULE 3.3    TOXICOLOGY
Type of application	Data required
New product / permit, existing active constituent – new formulation or major change in formulation1 New biological chemical product2 containing new active constituent, adjuvant or excipient New product / product variation, existing active constituent – extension from commercial use to use by a householder in the home / home garden Label variation – change to safety directions (hazard statements) and / or change to label first aid statements and / or poison scheduling Research permit, new active constituent, for non-food-producing use, with restrictions (single season / single use / specified research personnel)	A Toxicology data package for limited assessment requires submission of all of the following studies, or submission of valid scientific argument not to submit certain studies: chemistry and manufacture (data Part 2); acute toxicity studies: studies on the active constituent; studies on the product Detailed data requirements are in Part 3
MODULE 3.3    TOXICOLOGY
Type of application	Data required
New product / permit, new active constituent, where an overseas report or health assessment report has been supplied.3	A Toxicology data package for limited assessment requires submission of an acceptable overseas health report and a data package comprising all of the studies associated with that report. Detailed data requirements are in Part 3

Footnote 1: Definition of a major formulation change For the purposes of Module 3.3 a major formulation change is a change to the formulation of an agricultural or veterinary chemical product, including new combinations of existing active constituents, such that safety to humans, the environment and/or target species may need separate assessment.Some examples include: where there has been a significant increase in the concentration of active constituent which could affect the hazard potential, poison scheduling, safety directions or residues; where a major change in non-active constituent significantly affects the performance, stability or other attributes of the product; or where the formulation has been changed significantly to accommodate a new application method/use-pattern (e.g. changing from a wettable powder to an emulsifiable concentrate; changing from an oral drench to a topical pour-on dosage form).

Footnote 2: Definition of a biological chemical product: Biological chemical products may be either agricultural or veterinary chemical products. A biological chemical product is a chemical product where the active constituent comprises or is derived from a living organism (plant, animal, micro-organism, etc), with or without modification. Definition of a biotechnology chemical product: A biotechnology chemical product is one that is developed by means of one of the following biotechnological processes: recombinant DNA technology. controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells. hybridoma and monoclonal antibody methods.

Footnote 3: Definition of an applicant-supplied overseas report or health assessment report: The provision of a comprehensive toxicological assessment report on the active constituent, which is of OECD-acceptable quality and dated from 1 July 2005, would enable classification of the application as a Level 3 toxicology assessment. Note that summary reports would not be sufficient to modify the level of assessment required.

Module 4         Scheduling

MODULE 4    SCHEDULING
This is an additional module that applies to any application for either an agricultural or veterinary chemical, where the application must be referred to the NDPSC for poisons scheduling. Data requirements are covered by Toxicology modules 3.1, 3.2 or 3.3.

Module 5.1      Residues

MODULE 5.1    RESIDUES
Type of application	Data required
MRL, WHP, residues definition and trade assessment required: New product, new active constituent, food crop New product / product variation, existing active constituent – extension of use to food crop from non-food plant for the first time for the active constituent Permit, new active constituent – use in food crop	A Residues data package for comprehensive assessment requires submission of all of the following data, or submission of valid scientific argument not to submit certain studies: residues trial data; metabolism data; analytical methodology; residues-in-trade information for commodities listed in Part 5B of Volume 3 as follows: cattle cattle dairy products pigs sheep goats poultry and eggs abalone tuna prawns cereal grains citrus fruit grapes and wine (including dried grapes) oilseeds – canola seed and cottonseed (including derived oils and meals) pome fruit pulses   – lupins, field peas, chickpeas, faba beans, navy beans, mung beans stone fruit sugar oaten hay Detailed residue data requirements are in Part 5A Detailed trade data requirements are in Part 5B

Module 5.2      Residues

MODULE 5.2    RESIDUES
Type of application	Data required
MRL, WHP and trade assessment required: New product / product variation, existing active constituent –extension to or use in a major food crop Major formulation change1 New product / product variation, existing active constituent – major change in use pattern (including significant increase in application rate/frequency) Footnote 1: Definition of a major formulation change For the purposes of Module 5.2 a major formulation change is a change to the formulation of an agricultural or veterinary chemical product, including new combinations of existing active constituents, such that safety to humans, the environment and/or target species may need separate assessment. Some examples include: where there has been a significant increase in the concentration of active constituent which could affect the hazard potential, poison scheduling, safety directions or residues; where a major change in non-active constituent significantly affects the performance, stability or other attributes of the product; or where the formulation has been changed significantly to accommodate a new application method / use-pattern (e.g. changing from a wettable powder to an emulsifiable concentrate).	A Residues data package for reduced assessment requires submission of all of the following data, or submission of valid scientific argument not to submit certain studies: residues trial data; analytical methodology; residues-in-trade information for commodities listed in Part 5B of Volume 3 as follows: cattle cattle dairy products pigs sheep goats poultry and eggs abalone tuna prawns cereal grains citrus fruit grapes and wine (including dried grapes) oilseeds – canola seed and cottonseed (including derived oils and meals) pome fruit pulses   – lupins, field peas, chickpeas, faba beans, navy beans, mung beans stone fruit sugar oaten hay Detailed residue data requirements are in Part 5A Detailed trade data requirements are in Part 5B

Module 5.3      Residues

MODULE 5.3    RESIDUES
Type of application	Data required
MRL and WHP required: Permit, existing active constituent – use in new food crop	A Residues data package for reduced assessment for a permit application requires submission of residues data and analytical methodology for some or all of the following: preliminary residues trials; overseas residues trials; published residues information Detailed residue data requirements are in Part 5A

Module 5.4      Residues

MODULE 5.4    RESIDUES
Type of application	Data required
WHP ± MRL and trade assessment required: New product / product variation, existing active constituent – extension to or use in a non-major food crop Label variation with potential residue risks	A Residues data package for limited assessment requires submission of all of the following data, or submission of valid scientific argument not to submit certain studies: residues trial data; analytical methodology; residues-in-trade information (if appropriate) Detailed residue data requirements are in Part 5A Detailed trade data requirements are in Part 5B

Module 5.5      Residues

MODULE 5.5    RESIDUES
Type of application	Data required
WHP ± MRL required: Permit application, existing active constituent – minor use, emergency use or research permit for a food crop	A Residues data package for limited assessment requires submission of published residues information and / or valid scientific argument to support the permit application. Detailed residue data requirements are in Part 5A

Module 6.1      Occupational Health & Safety

MODULE 6.1    OCCUPATIONAL HEALTH & SAFETY
Type of application	Data required
New product, new active constituent, including biological chemical product2	An OH&S data package for comprehensive assessment requires submission of all of the following data, or submission of valid scientific argument not to submit certain information: Hazard: physical and chemical properties: active constituent product; individual constituents; toxicology; Occupational exposure: mixing and loading; product application; re-entry and re-handling; dermal absorption; Risk management and workplace information:   measures to control occupational exposure: before and during end-use; re-entry or re-handling product label; Material Safety Data Sheet (MSDS); training requirements; occupational exposure monitoring: atmospheric monitoring; health surveillance; tank mixing; contraindications Risk assessment: margin of exposure (MOE); further requirements where the MOE is inadequate; risk assessment proposed by the applicant (acute and repeat dose) Detailed data requirements are in Part 6

Module 6.2      Occupational Health & Safety

MODULE 6.2    OCCUPATIONAL HEALTH & SAFETY
Type of application	Data required
Permit for use by all persons of a formulation containing a new active constituent	An OH&S data package for reduced assessment requires submission of all of the following data, or submission of valid scientific argument not to submit certain information: Hazard: physical and chemical properties: active constituent product; individual constituents; toxicology; Occupational exposure: mixing and loading; product application; re-entry and re-handling; dermal absorption; Risk management and workplace information: measures to control occupational exposure: before and during end-use; re-entry or re-handling product label; Material Safety Data Sheet (MSDS); training requirements; tank mixing; contraindications Detailed data requirements are in Part 6
MODULE 6.2    OCCUPATIONAL HEALTH & SAFETY
Type of application	Data required
New product, existing active constituent – major formulation change1 New product / product variation, existing active constituent – involving new crop group / new situation and / or new application method	Hazard: physical and chemical properties: active constituent product; individual constituents; Occupational exposure: mixing and loading; product application; re-entry and re-handling; dermal absorption; Risk management and workplace information:   measures to control occupational exposure: before and during end-use; re-entry or re-handling ; product label; Material Safety Data Sheet (MSDS); training requirements; occupational exposure monitoring: atmospheric monitoring; health surveillance; tank mixing; contraindications Risk assessment: margin of exposure (MOE); further requirements where the MOE is inadequate; risk assessment proposed by the applicant (acute and repeat dose) Detailed data requirements are in Part 6

Module 6.3      Occupational Health & Safety

MODULE 6.3    OCCUPATIONAL HEALTH & SAFETY
Type of application	Data required
Permit, existing active constituent – new application method or new use situation, for use by all persons Label variation – change / reassessment of user Safety Directions and / or re-entry or re-handling statements	An OH&S data package for limited assessment requires submission of all of the following data, or submission of valid scientific argument not to submit certain information: Hazard: physical and chemical properties: active constituent product; individual constituents; Occupational exposure: mixing and loading; product application; re-entry and re-handling; Risk management and workplace information:   measures to control occupational exposure: before and during end-use; re-entry or re-handling; product label; Material Safety Data Sheet (MSDS); training requirements; tank mixing; contraindications Detailed data requirements are in Part 6

Footnote 1: Definition of a major formulation change For the purposes of Module 6.2 a major formulation change is a change to the formulation of an agricultural or veterinary chemical product, including new combinations of existing active constituents, such that safety to humans, the environment and/or target species may need separate assessment.  Some examples include: where there has been a significant increase in the concentration of active constituent which could affect the hazard potential, poison scheduling, safety directions or residues; where a major change in non-active constituent significantly affects the performance, stability or other attributes of the product; or where the formulation has been changed significantly to accommodate a new application method/use-pattern (e.g. changing from a wettable powder to an emulsifiable concentrate).

Modules 7.1, 7.2, 7.3    Environment

MODULES 7.1, 7.2, 7.3    ENVIRONMENT
MODULE 7.1	Data required
Type of application
New product, new active constituent New product, new combination of existing active constituents – extension of use to new crop, new situation	An Environment data package for comprehensive, reduced or limited assessment requires submission of all of the following studies, or submission of valid scientific argument not to submit certain studies: Environmental chemistry and fate assessment of the extent of, and potential for, environmental exposure: amount of chemical to be used; manufacturing plant of the active constituent; formulating plant of the product; use and application; product disposal; accidental release; physicochemical degradation: hydrolysis; photodegradation (aqueous, soil, degradation in air); biodegradation: soils (aerobic, anaerobic); water; mobility: volatility; adsorption/desorption; leaching potential; field dissipation: soils; water; air; plants; accumulation/metabolism: bioaccumulation in fish and aquatic organisms; accumulation potential in soils; metabolism in target animals; other species e.g. birds, earthworms; modelling studies Environmental toxicology wild birds, mammals and other vertebrates: acute; short-term; special studies – chronic, reproduction, simulated or actual field testing; aquatic organisms (freshwater and marine): acute (fish, microcrustacea, algae); short-term (sub-chronic); special studies — chronic, sediment, simulated or actual field testing non-target terrestrial invertebrates: predators; parasites; bees; earthworms and soil invertebrates; soil micro-organisms; other; non-target vegetation: results from laboratory tests; observations from field trials or efficacy tests; assessment of environmental hazard Detailed data requirements are in Part 7
MODULE 7.2
Type of application
New product / variation to an existing product, containing existing active constituents – extension of use to new crop or new situation New product / product variation – major formulation change1 or increased application rate Product variation – extension to aerial use Product containing new active constituent for use under permit
MODULE 7.3
Type of application
New product / product variation, (excluding all vertebrate poisons), containing new or existing active constituents, where the product is for use: by the householder in the home / home garden / swimming pool / spa; or in buildings not used in animal production (e.g. warehouses, offices, glasshouses); or as a treatment for stored produce or goods; or as a post-harvest application to any crop Label variation – change to environmental instructions and warnings Product containing existing active constituent for use under permit

Footnote 1: Definition of a major formulation change For the purposes of Module 7.2 a major formulation change is a change to the formulation of an agricultural or veterinary chemical product, including new combinations of existing active constituents, such that safety to humans, the environment and/or target species may need separate assessment.Some examples include: where there has been a significant increase in the concentration of active constituent which could affect the hazard potential, poison scheduling, safety directions or residues; where a major change in non-active constituent significantly affects the performance, stability or other attributes of the product; or  where the formulation has been changed significantly to accommodate a new application method/use-pattern (e.g. changing from a wettable powder to an emulsifiable concentrate).

Module 8.1      Efficacy and host crop safety

MODULE 8.1    EFFICACY & HOST CROP SAFETY
Type of application	Data required
New product containing: new active constituent; or new combination of existing active constituents1; or significant new formulation not included in module 8.21 New or existing product: existing active constituent for use in a new crop group / situation and / or for the control of new pests	An Efficacy and Host Crop Safety data package for comprehensive assessment requires submission of all of the following Australian studies, or submission of valid scientific argument not to submit certain studies:Efficacy studies efficacy studies for every host and pest claimed on the label; studies to demonstrate the optimum application rate for each host / pest combination Host crop safety studies safety to host crop including yield data; safety to following crops; safety to non-target crops; effects on taste of produce (organoleptic effects) Other related studies compatibility / tank mix tests; studies conducted overseas; effects of residues on subsequent processing; animal welfare; safety to non-target animals; implications for resistance management; effects on other industries Detailed data requirements are in Part 8

Module 8.2      Efficacy and host crop safety

MODULE 8.2    EFFICACY & HOST CROP SAFETY
Type of application	Data required
Existing product: extension of use to a new host or a new pest within the same crop group / situation and with the same general use pattern New or existing product: existing active constituent, new household / home garden use extension to a minor use for new pests where the use and pests are closely similar to an existing use pattern significant new formulation / change in use pattern requiring reduced assessment of both efficacy and safety1	An Efficacy and Host Crop Safety data package for reduced assessment requires submission of all of the following Australian studies, or submission of valid scientific argument not to submit certain studies: Efficacy studies efficacy studies for any new host or pest claimed on the label; studies to demonstrate the optimum application rate for the new host/pest combination Host crop safety studies (if a new crop or higher application rate is proposed) safety to target crops including yield data; safety to following crops; safety to non-target crops Other related studies studies conducted overseas; safety to non-target animals; implications for resistance management; effects on other industries Detailed data requirements are in Part 8

Module 8.3      Efficacy and host crop safety

MODULE 8.3    EFFICACY & HOST CROP SAFETY
Type of application	Data required
New product where efficacy and safety data are required to demonstrate similarity to an existing registered product Label or formulation changes that are expected to have a minor impact on efficacy or crop safety1 Extension to a minor use within the same crop group / situation for an existing pest and application rate Permit application – minor use in a new crop / situation	An Efficacy and Host Crop Safety data package for limited assessment requires submission of all of the following Australian studies, or submission of valid scientific argument not to submit certain studies: Efficacy studies target efficacy studies to demonstrate comparable efficacy with the registered reference product Host crop safety studies host crop safety studies to demonstrate that any phytotoxicity and yield effects are comparable to the registered reference product Detailed data requirements are in Part 8

Footnote 1: Major formulation change For the purposes of efficacy and safety a major formulation change is a change to the formulation of an agricultural or veterinary chemical product, including new combinations of existing active constituents, such that efficacy and/or safety to the host crop requires assessment.  Some examples include: where there has been a significant change in the concentration of active constituent and where the application/dose rate to the crop is changed; or where a major change in non-active constituent significantly affects the performance, stability or other attributes of the product; or where there has been a significant change in product specifications; or where the formulation has been changed significantly to accommodate a new application method/use-pattern (e.g. changing from a wettable powder to an emulsifiable concentrate); or where the new formulation is not identical, not closely similar, and not similar to a registered reference product. Major changes in formulation are expected to require assessment under Module 8.1.  However, applicants may provide valid scientific argument regarding submission of relevant efficacy/safety data to justify a different level of assessment.  For example: If the change in formulation is likely to affect only efficacy or safety, assessment under Module 8.3 could be appropriate; Data to demonstrate comparable efficacy/bioequivalence with the previous formulation could be assessed under Module 8.3.

Module 9         Non-food trade

MODULE 9    NON-FOOD TRADE
Type of application	Data required
Agricultural chemicals involving trade risks not related to food residues, including: genetically-modified produce	Data specifically relevant to the trade risk

Module 10.3   GM Organism / Other Special Data

MODULE 10.3    GM ORGANISM / OTHER SPECIAL DATA
Type of application	Data required
Any application requiring an assessment of special data such as assessment of a product containing a genetically-modified organism (GMO)	Published data and results of Australian field trials relevant to the criteria for approval of an active constituent or registration of a product, described in s.14 of the Agvet Code

4.    MODULE FEES AND TIMEFRAMES

  – amended from Schedule 7 to the Regulations to the Agvet Code

Module	Fee*	Timeframe†
1        Screening	$505
2.1     Chemistry	$3,255	12 months
2.2     Chemistry	$2,230	8 months
2.3     Chemistry	$1,030	5 months
2.4     Chemistry	$200	3 months
3.1     Toxicology	$19,490	12 months
3.2     Toxicology	$14,620	8 months
3.3     Toxicology	$2,900	4 months
4        Scheduling	$3,720	12 months
5.1     Residues	$5,595	12 months
5.2     Residues	$4,765	6 months
5.3     Residues	$2,490	6 months
5.4     Residues	$2,230	3 months
5.5     Residues	$1,175	3 months
6.1     OH&S	$4,310	12 months
6.2     OH&S	$2,900	6 months
6.3     OH&S	$1,435	4 months
7.1     Environment	$12,605	12 months
7.2     Environment	$3,255	6 months
7.3     Environment	$620	4 months
8.1     Efficacy & host crop safety	$1,865	5 months
8.2     Efficacy & host crop safety	$750	4 months
8.3     Efficacy & host crop safety	$500	3 months
9        Non-food trade	$1,175	5 months
10.1   Antibiotic resistance	Nil fee	12 months
10.2   Antibiotic resistance	Nil fee	6 months
10.3   GM Organism / other special data	Nil fee	6 months
11.1   Finalisation	$2,230	3 months
11.2   Finalisation	$1,175	2 months
11.3   Finalisation	$620	2 months
11.4   Finalisation	$160	2 months
12      Data protection	$170

* To calculate the fee for the application, total the modular fees for all items.

† To calculate the assessment period for the application, add the longest assessment period for modules 2–10 to the relevant module 11 assessment period.

APPENDIX A:   Further detail on the modules

Module for screening of applications

1.      This module covers administrative work, handling and advice at screening for all applications before they are accepted for evaluation.

Modules for assessment of product quality, batch-to-batch consistency and stability

2.1    This module covers an application that requires a comprehensive assessment of chemistry and manufacture data for both the active/s and the product.

2.2    This module covers an application that requires a reduced assessment of chemistry and manufacture data for the active/s and the product that is not as extensive as the assessment required in 2.1 above.

2.3    This module covers an application that requires an assessment of chemistry and manufacture data for the product only.

2.4    This module covers an application for a variation to chemistry and manufacture details for the product, or any other application requiring a limited chemistry and manufacture assessment.

Modules for assessment of toxicological hazards and advice of public health standards

3.1    This module covers an application that requires a comprehensive assessment of toxicological data for the active/s and the product.

3.2    This module covers an application that requires a reduced assessment of toxicological data that is not as extensive as the assessment required in 3.1 above.

3.3    This module covers any other application requiring a limited toxicological assessment.

4.      This module covers drugs and poisons scheduling.

Modules for assessment of food residue levels and human dietary residue exposure and advice on maximum residue limit standards

5.1    This module covers an application that requires a comprehensive assessment of residue data.

5.2    This module covers a registration application that requires a reduced assessment of residue data that is not as extensive as the assessment required in 5.1 above.

5.3    This module covers a permit application that requires a reduced assessment of residue data that is not as extensive as the assessment required in 5.1 above.

5.4    This module covers any other registration application requiring a limited residue assessment.

5.5    This module covers any other permit application requiring a limited residue assessment.

Modules for assessment of personal user safety

6.1    This module covers an application that requires a comprehensive assessment of occupational health and safety data.

6.2    This module covers an application that requires a reduced assessment of occupational health and safety data that is not as extensive as the assessment required in 6.1 above.

6.3    This module covers any other application requiring a limited occupational health and safety assessment.

Modules for assessment of environmental safety

7.1    This module covers an application that requires a comprehensive assessment of environmental data.

7.2    This module covers an application that requires a reduced assessment of environmental data that is not as extensive as the assessment required in 7.1 above.

7.3    This module covers any other application requiring a limited environmental safety assessment.

Modules for assessment of label claims and adequacy of label instructions and precautions relating to target species efficacy and safety

8.1    This module covers an application that requires an efficacy and safety review carried out on either:

1. an agricultural chemical product containing:
   1. a new active constituent; or
   2. a new combination of active constituents; or
   3. an existing active constituent/s for use in a new crop or situation; or
   4. a significant new formulation not included in module 8.2; OR
2. a veterinary chemical product for use in/on a food-producing species containing:
   1. a new active constituent; or
   2. a new combination of active constituents; or
   3. an existing active constituent/s for use in/on a new food animal

8.2   This module covers an application that requires an efficacy and safety review carried out on either:

1. an agricultural chemical product when module 8.1 is not justified (for example, an extension of use within the same food group); OR
2. a veterinary chemical product:
   1. used on companion animals (dog, cat or horse); or
   2. where extension of use is in/on the same food-producing species; or
   3. where a new formulation for a product for use in/on a food-producing species is not identical, closely similar or similar to a reference product.

8.3   This module covers any other application requiring a target species efficacy and/or safety review.

Module for assessment of non-food trade risk

9.      This module covers an application requiring assessment of trade risk relating to non-food residue situations e.g.– fibre residues, presence of disease or seropositive testing to exotic or notifiable disease agents, genetically modified produce.

Modules for assessment of other data

10.1  This module covers an application that requires a comprehensive assessment of part 10 special data.

10.2  This module covers an application that requires a reduced assessment of part 10 special data that is not as extensive as the assessment required in 10.1 above.

10.3  This module covers any other application requiring an assessment of special data such as assessment of product containing a GMO.

Module for administrative and technical steps in public consultation and finalisation of applications

11.1  This module covers finalisation of a registration or permit application that requires three or more modular assessments covered in items 2.1 to 10.3 above, except for item 2.4.

11.2  This module covers a registration application that requires less than three of the modular assessments covered in items 2.1 to 10.3 above.

11.3  This module covers a permit application that requires less than three of the modular assessments covered in items 2.1 to 10.3 above.

11.4  This module covers any minor application requiring technical assessment including modular items 2.4.

Module for assigning data protection

12.    This module covers administrative and technical steps in assigning protection to relevant data.

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