I want to vary the use of a product to include a new crop, animal species or situation

Varying the use of an agricultural or veterinary chemical product to include a new use is also known as an ‘extension of use’. This variation is made via:

  • Item 11 – full assessment fixed fee application
  • Item 12 – no data of a technical nature is required—this application type is used when risks are equivalent to a registered product not subject to data protection
  • Item 14 – technical modular application—all applications not described in any of items 11 to 13A.

Most ‘extension of use’ variations are likely to be made as Item 14 applications.

This guidance does not consider an extension of use where the variation is to extend the use from commercial use to domestic use in the home or home garden.

Definitions for food crop, non-food crop, non-food situations, food-producing animal species, and non-food producing animal species (companion animals) are listed in the APVMA’s Definition of terms.

Note: Food producing crops include any crop that is consumed in Australia by humans or livestock. This includes pasture and forage crops which are grown specifically for the purpose of being grazed.

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Varying the use of an agricultural or veterinary chemical product to include a new use is also known as an ‘extension of use’. This variation is made via:

  • Item 11 – full assessment fixed fee application
  • Item 12 – no technical assessment is required
  • Item 14 – technical modular application—all applications not described in any of items 11 to 13A.

Most ‘extension of use’ variations are likely to be made as Item 14 applications.

This guidance does not consider an extension of use where the variation is to extend the use from commercial use to domestic use in the home or home garden.

Note: Food producing crops include any crop that is consumed in Australia by humans or livestock. This includes pasture and forage crops which are grown specifically for the purpose of being grazed.

Introduction

The following material provides guidance for varying the use of an agricultural chemical product where the change involves an extension of use to a non-food producing crop or situation as a technical modular variation (Item 14). Depending on the nature of the variation, different technical assessment modules will apply. In general, an extension of use requires the submission of new information or data to support the safety and efficacy of the new use. The amount of new information or data required however can vary depending upon how significant the change is, and what new assessments are necessary.

Legislation

Framework

The Agricultural and Veterinary Chemicals (Administration) Act establishes the APVMA as an independent statutory authority of the Commonwealth, responsible for the regulation and control of agvet chemicals in Australia up to the point of retail sale. This Act contains all of the internal details of the establishment of and the functions and powers of the APVMA. It also contains provisions controlling the import and export of chemicals.

The Agricultural and Veterinary Chemicals Act contains the constitutional and other legal provisions that enable the Agvet Code to have effect.

The Agricultural and Veterinary Chemicals Code Act, among other things, contains the detailed provisions allowing the APVMA to evaluate, approve or register and review active constituents and agricultural and veterinary chemical products (and their associated labels); and to issue permits and to license the manufacture of chemical products. It also contains provisions for controls to regulate the supply of chemical products; and provisions ensuring compliance with, and for the enforcement of, the code.

The Agricultural and Veterinary Chemicals Code Regulations 1995 prescribe detailed provisions of the Agvet Code.

The Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 sets out the information that must be contained in, or accompany an, application under the Agvet Code.

Section 6A of the Agricultural and Veterinary Chemicals Code Act states that the APVMA may make guidelines. The APVMA has a number of guidelines which fall under this, for example:

Statutory criteria

In addressing the criteria, the applicant may provide information, or valid scientific argument that might address a specific criterion. The following sections of the Agvet Code provide definitions for meeting the criteria:

An active constituent or chemical product meets the safety criteria if use of the constituent or product, in accordance with any instructions approved, or to be approved, by the APVMA for the constituent or product or contained in an established standard:

a) is not, or 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
b) is not, or would not be, likely to have an effect that is harmful to human beings; and
c) is not, or would not be, likely to have an unintended effect that is harmful to animals, plants or things or to the environment.

To satisfy the S5A criteria, the APVMA considers chemistry and manufacture, toxicology (including poison scheduling, residues, work health and safety, environment and target safety).

A chemical product meets the efficacy criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA for the product or contained in an established standard, is, or would be, effective according to criteria determined by the APVMA by legislative instrument.

A chemical product meets the trade criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA or contained in an established standard, does not, or would not, unduly prejudice trade or commerce between Australia and places outside Australia.

In approving a label for a container for chemical products, the APVMA must be satisfied that the label contains adequate instructions. This allows the APVMA to ensure that the risks of using the agvet chemical product are adequately mitigated through appropriate instructions.

The APVMA’s Agricultural Labelling Code and Veterinary Labelling Code also contain further labelling requirements that ensure a standard layout, eligibility and further help in mitigating the risk of using agvet chemical products when used in accordance with the label instructions.

Varying relevant particulars and conditions

The APVMA must vary the relevant particulars or conditions if it is satisfied application requirements and statutory criteria have been met (Section 29 of the Agvet Code).

Section 20(1)(c) of the Agvet Code defines relevant particulars in relation to the registration of a chemical product as:

  • the distinguishing number
  • any instructions for the use of the product
  • any other particulars prescribed by the regulations.

Other particulars for chemical products prescribed by the regulations are:

(a)  the distinguishing name of the chemical product
(b)  the constituents of the chemical product
(c)  the concentration of each constituent of the chemical product
(d)  if possible, the composition and purity of each active constituent of the chemical product
(da)  the formulation type for the chemical product
(db)  the net contents for the chemical product
(e)  identifying information for the holder of the registration of the chemical product
(g)  the name of each manufacturer of the chemical product
(h)  the address of each site at which the chemical product is manufactured by the manufacturer
(j)  the date of entry of these particulars in the Register of Chemical Products
(k)  identifying information for any nominated agent for the registration.

The Agvet Code defines particulars in relation to approval of a label as:

(i) the name of the person who applied for the approval as the holder of the approval
(ii) the name of any nominated agent for the approval
(iii) the distinguishing number
(iv) the instructions and any particulars that are to be contained on the label
(iva) any other particulars prescribed by the regulations
(v) any conditions of the approval imposed by the APVMA.

Other particulars for labels prescribed by the regulations are:

Regulation 17(1)

a) the appropriate signal words required by the current Poisons Standard
b) the name of the chemical product that is to appear on a label for containers of the chemical product
c) the name of each active constituent of the product
d) the proportion of each active constituent of the product
e) the name of each constituent for the product that is

a. not an active constituent; and
b. classified as a poison in the current Poisons Standard

f) the proportion of each constituent referred to in paragraph (e)
g) the net contents of the product
h) particulars determined by the APVMA CEO under subregulation (2).

Regulation 17(2)

For paragraph 6(2)(c) of the Act, the APVMA CEO may determine additional particulars to be placed on a label for a product.

Regulation 17(3)

a) identifying information for the holder of the approval
b) identifying information for any nominated agent for the approval
c) the distinguishing name of the chemical product that is prescribed under paragraph 16(a) and entered in the Register
d) the distinguishing number of the chemical product that is entered in the Register.

Application requirements

Section 8A of the Agvet Code provides the definition of 'meets the application requirements'.

Parts 2 and 4 of the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument sets out the information that must be contained in, or accompany an, application under the Agvet Code.

Guidelines

6A of the Agvet Code states that the APVMA may make written guidelines for performing its functions and exercising its powers under this Code.

The APVMA has designed guidelines to help inform the APVMA and applicants as to the modules, data and information that will apply for different types of applications. The guidelines are not the law. The APVMA will have regard to it, but from time to time may depart from it when determining the modules, data and information are necessary for a particular application. The APVMA has a number of guidelines which fall under this, for example:

Applications may be withdrawn

Section 8D of the Agvet Code states that at any time after the application is made and before it is determined, the applicant may withdraw it by giving the APVMA written notice of the withdrawal signed by the applicant.

Section 20(1)(e) of the Agvet Code states that any conditions of the registration imposed by the APVMA must be entered in the Register.

Timeframe and fees

A technical variation is a modular application type, therefore the fees and timeframe are variable. Legislative timeframes commence once the application has passed preliminary assessment and fees have been paid.

Applications for ‘extension of use’ to include a non-food producing species must satisfy the statutory criteria of safety, efficacy and trade. Depending on the extension being sought, one or more of the following module types 2–10 will require the provision of supporting data and/or scientific argument. Where an applicant considers that an assessment of any particular module is not necessary justification must be provided.

Extension of use: required modules
Module type Module level* Timeframe Fee
1: Preliminary assessment 1.0 Up to 30 days $710
2: Chemistry No assessment required as there has been no change to formulation or packaging    
3 Toxicology 3.3 5 months $4 050
4 Toxicology—Poison scheduling No assessment required if appropriate scheduling is already in place    
5 Residues and trade No assessment required as risks are considered under Non-food trade module    
6 Work health and safety 6.2 or
6.3
7 months
4 months
$3 185
$2 910
7 Environment 7.2 or
7.3
7 months
4 months
$7 315
$1 720
8 Efficacy and safety 8.1 or
8.2 or
8.3
6 months
4 months
3 months
$2 370
$975
$580
9 Non-food trade 9.0 6 months $1 175
10 Special data 10.3 7 months Nil
11 Finalisation 11.1 or
11.2
3 months
2 months
$4 055
$1 545
12 Limits of use 12.0 $460

*Only those module levels applicable for this type of variation are listed.

Extension of use: examples
Scenario Modules Timeframe Fee

1: Extension to include a new non-food use

1.0, 6.3, 11.2 and 12 6 months
9 months (extended assessment period)
$3 690

2: Extension to include a new situation

1.0, 7.2, 8.1, 11.2 and 12 9 months
13 months (extended assessment period)
$12 400

3: Extension to include a new situation (turf)

1.0, 7.2, 8.1, 11.2 and 12 9 months
13 months (extended assessment period)
$15 585

This application type is subject to an extended assessment period if a section 159 of Agvet Code notice is sent requesting additional information or clarification of submitted information. The extended assessment period will vary, depending on the nature of the application and the modules specified for that particular application.

Pre-application assistance

Pre-application assistance is designed to give applicants advice on the information and module requirements of an application prior to submission. It can also be used to obtain an appraisal on a trial protocol or for agreement on project plans for time shift applications.

Tier 1: $577.50
This tier is designed to support the early stages of preparing an application, such as guidance and clarification on the types of assessments necessary for the proposed application.

Tier 2: $962.50
This is used for technical advice to support a particular application and to give applicants greater confidence that their proposed submission will contain the relevant information to address the safety, efficacy and trade criteria.

Tier 3: $1,347.50 + $1,155 per additional module chosen
This advice level can include an appraisal of a specific study design and finalisation of project plans for time shift applications.

Rebate: In some circumstances, where a pre-application assistance fee was paid in relation to a proposed product application, your product application fee will be reduced by an amount prescribed in the Agvet Code Regulations.

Modules

The APVMA has developed a guideline for module descriptors to provide guidance as to the modules that will apply for different types of applications. The APVMA will have regard to it, but may depart from it, when determining which modules are necessary on a case by case basis. The guideline is not the law.

An extension of use to new crops, animal species or situations must satisfy the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria for the new use. However, the amount of new information or data required varies depending upon how significant the change is, and what new assessments are necessary.

Module 1: Preliminary assessment

Preliminary assessment is an initial examination of the application for administrative completeness. It is an administrative check that the form and content of the application meet the application requirements. In other words, the outward look of the application and its accompanying information appears to be in order and complete. It is not a completeness check of the technical aspects of your submission.

Applies to all modular application items.

Module 3: Toxicology

This module assesses both toxicological data and scientific argument, together with any cited references, which characterise the risks to humans using or coming into contact with the substances in your product.

3.3: Toxicology – Level 3

d. A variation which requires or involves:

  1. changes to the Poisons Standard; and/or
  2. establishing first aid and hazard statements.
Module level Module type Timeframe Fee
3.3 Toxicology 5 months $4 050

Module 4: Toxicology (poison schedule classification)

In addition to a Module 3 Toxicology, a scheduling assessment is required where the current entry for the active constituent in the product, published in the Standard for the uniform scheduling of medicines and poisons (SUSMP—produced by the Australian Government Department of Health), is NOT relevant to the new proposed use.

Some SUSMP entries may refer to use in a specific species or situation, which would not be relevant to your proposed use.

Applications that are referred to the Secretary of the Department of Health for poisons scheduling, in addition to a module 3 level.

Module level Module type Timeframe Fee
4.1 Toxicology—poison schedule classification 13 months $2 435

Module 6: Work health and safety

A work health and safety (WHS) assessment is required where there is a change to human exposure. Changes to human exposure can occur when extending into new crops or situations. These exposures include changes such as application rate, method, worker rates and practices including post application activities. The change in exposure may result in a change to the entry in the First aid instructions and safety directions (FAISD) handbook, including changes to personal protective equipment (PPE) and re-entry into treated areas following application.

Work Health and Safety – Level 2 (Module 6.2) is required when the application involves an extension to a new crop group or situation.

6.2: Reduced work health and safety assessment

b. A variation which involves:

  1. a change in use pattern to include a new crop group or situation; or
  2. a new application method.
Module level Module type Timeframe Fee
6.2 Workplace health and safety 7 months $3 185

6.3: Limited workplace health and safety

Work Health and Safety—Level 3 (Module 6.3) is required where the application involves a change or reassessment of user safety directions and/or re-entry or re-handling statements.

b. A variation that is not referred to in module 6.2 above, that requires a WH&S assessment due to a varied exposure scenario (for example, to consider re-entry/re-handling statements and/or safety directions).

Module level Module type Timeframe Fee
6.3 Workplace health and safety 4 months $2 910

Module 7: Environment

Where there is any potential risk to the environment, an appropriate environmental assessment is required. This assessment will take into account the expected volume of use; the expected exposure, behaviour and fate of the active constituent/s; and the potential harmful effects on flora and fauna; resulting from use of the product.

In situations where the proposed use pattern does not change the risk to the environment, and this can be determined without further assessment, no environmental assesment is required.

A Reduced Environment Assessment (Module 7.2) applies when

(i) extending into a new crop group (e.g. from broadacre to orchard situation); or
(ii) extending into a new crop or an existing crop group involving an increase in application rate per hectare or frequency.

A Limited Environment Assessment (Module 7.3) applies where there is a change in an existing use pattern involving a change to the timing or frequency of application or extending to different application equipment (eg moving between pre-emergent and post-emergent application in broad-acre crops or moving from two applications per crop to a maximum of four applications per crop required for the control of a new pest or disease).

In situations where the proposed variation does not change the risk to the environment, and this can be determined without further assessment, no environment assessment is required. For example, when extending into a new crop, within the same crop group, with the same application rate (eg oranges to mandarins).

7.2: Environment – Level 2

b. A variation which involves:

  1. a new crop in a new crop group or new situation; or
  2. increase application rate or frequency for an existing use pattern.
Module level Module type Timeframe Fee
7.2 Environment 7 months $7 315

7.3: Environment – Level 3

b. A variation which involves:

  1. a new crop in an existing crop group;
  2. domestically in the home, home garden or a swimming pool or spa; or
  3. in buildings not used in animal production (for example, warehouses, offices, or glasshouses).

Module 8: Efficacy and safety

Efficacy assessment ensures that the product works as described on the label, when used according to label directions.

Safety assessment ensures that the product is safe to use on or in the target crop or animal, when used according to label directions.

An efficacy and safety assessment may include assessing the effect of the product on crops, non-target crops and germinaton, effects of residues, organoleptic tests or pharmacologic studies.

A Comprehensive efficacy and safety assessment (Module 8.1) is required for applications that involve extension into new crops in a new crop group or new situations.

A Reduced efficacy and safety assessment (Module 8.2) is required for extensions to a new crop within the same crop group.

A Limited efficacy and safety assessment (Module 8.3) is required for extension to a new crop where you are seeking to establish equivalence to the same use on another registered product and where the use on that registered product is not subject to limits of use of information.

8.1: Comprehensive efficacy and safety

8.1.c  A variation which involves a new crop in a new crop group or new situation.

Module level Module type Timeframe Fee
8.1 Efficacy and target crop safety 6 months $2 370

8.2: Reduced efficacy and safety

b. A variation which involves:

  1. a new crop within an existing crop group;
  2. a new pest within the same crop group or situation; or
  3. new domestic or home garden use.
Module level Module type Timeframe Fee
8.2 Efficacy and target safety 4 months $975

8.3: Limited efficacy and safety

b. A variation which involves:

  1. a formulation change; or
  2. where only bioequivalence (including scientific argument) is required to demonstrate the efficacy and crop safety to a currently registered product.
Module level Module type Timeframe Fee
8.3 Efficacy and target safety 3 months $580

Module 9: Non-food trade

The non-food trade module is applied to applications involving trade risks not related to food residues.

a. A product involving trade risks not related to food residues, including:

  1. residues in wool and fibre, or
  2. genetically modified produce.
Module level Module type Timeframe Fee
9 Non-food trade 6 months $1 175

Module 10: Special data assessment

This module applies to all applications for registration of a new chemical product or variation of the particulars or conditions of a registered chemical product, which contain active constituents that are new antibiotic substances or which contain genetically modified organisms (GMOs) require a module 10 assessment.

Specifically, you should consider the following guidelines:

b. A product including an assessment of products containing GMOs, requiring a module 10 assessment.

Module level Module type Timeframe Fee
10.3 Genetically modified organism 7 months $Nil

Module 11: Finalisation

This module encompasses administrative steps relating to the finalisation of the application. This can include public consultation, entering the required information into the relevant record or register, and the completion of the technical evaluation and risk assessment report outlining the evaluation of the application.

Note: Module 11.2 is included when fewer than 3 modules between 2.1 to 10.3 apply and module 11.1 is included when 3 or more modules between 2.1 to 10.3 apply.

11.1: Finalisation – level 1

b. A variation where three or more modules between 2.1 to 10.3 apply.

Module level Module type Timeframe Fee
11.1 Finalisation 3 months $4 055

11.2: Finalisation – Level 2

b. A variation where fewer than three modules between 2.1 to 10.3 apply.

Module level Module type Timeframe Fee
11.2 Finalisation 2 months $1 545

Module 12: Limits on use of information

Module 12 relates to the protection, handling and use of information provided to the APVMA. In general, the APVMA must not use information given to it in connection with one application to assess or make a decision on another application, except in specific circumstances. These circumstances include, but are not limited to, where the applicant has given consent for the information to be shared or in an emergency situation; see CCI Practice Statement. This ‘limited use data’ includes information such as reports, studies and scientific arguments that may or may not include confidential commercial information. The applicant can request the module at the time an application is lodged, but the APVMA may also include it once an assessment of the application is undertaken.

Module level Module type Timeframe Fee
12 Data protection N/A $460

Pre-application assistance

Pre-application assistance is designed to give applicants advice on the requirements for an application before submission. It can also be used to obtain an appraisal on a trial protocol or for agreement on project plans for time shift applications.

Tier 1: $577.50
This tier is designed to support the early stages of preparing an application, such as guidance and clarification on the types of assessments necessary for the proposed application.

Tier 2: $962.50
This is used for technical advice to support a particular application and to give applicants greater confidence that their proposed submission will contain the relevant information to address the safety, efficacy and trade criteria.

Tier 3: $1,347.50 + $1,155 per additional module chosen
This advice level can include an appraisal of a specific study design and finalisation of project plans for time shift applications.

Rebate: In some circumstances, where a pre-application assistance fee was paid in relation to a proposed product application, your product application fee will be reduced by an amount prescribed in the Agvet Code Regulations.

What you need to provide

To meet the application requirements you will need to provide:

  • an online application form
  • the application fee plus any amount that is due to the APVMA
  • supporting information to demonstrate the proposed extension will be efficacious and will not cause unintended harm
  • an information list
  • consent for use (if any of the information provided is subject to limits of use)
  • e-label.

Completed online application form

First time applicants will need to complete an online services new user access form to access APVMA online services.

If you are unfamiliar with the application process you may wish to consult the guide to completing an online application.

The application fee

You may choose to:

  • pay the total fee on submission or
  • pay the preliminary assessment fee of $710 on submission and the remaining balance once the application has been accepted.

You can choose to pay by credit card, electronic funds transfer or BPAY.

Note: To meet the application requirements you must pay any amount (including an amount in respect of a tax or penalty) that is due and payable by you to the APVMA (including under a law of another jurisdiction or the agvet law).

Supporting information

The application must contain or be accompanied by, information relevant to whether the chemical product meets the safety and efficacy criteria. Applicants should include an explanation why supporting information is not required, if not providing it with the application. If the APVMA accepts the justification for non-submission of specific data, the application may be recategorised as an item 2 application, and appropriate modules will apply.

  • Chemistry
    Detailed data guidelines for chemistry and manufacture are available in Part 2
  • Toxicology
    Detailed data guidelines for toxicology are available in Part 3
  • Residues
    Detailed data guidelines for residues are available in Part 5A
    Detailed data guidelines for trade are available in Part 5B
  • Occupational health and safety
    Detailed data guidelines for occupational health and safety are available in Part 6
  • Environment
    Detailed data guidelines for environment are available in Part 7
  • Efficacy and host crop safety
    Detailed data guidelines for efficacy and safety are available in Part 8
  • Trade
    Detailed data guidelines for trade are available in Part 5B
  • Non-food trade
    For application referred to at part 9 of the module descriptors 6A guideline, data specifically relevant to the trade risk may be submitted
  • GM organism/other special data
    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 s14 of the Agvet Code, may be submitted.

Information list

It is an application requirement that all applications for approval, registration or variation include a short description of each item of information contained in, or accompanying the application—an information list.

Any document (information) submitted with the application constitutes information for the purposes of the information list. This includes supporting information, such as consent for use letters, manufacturer's declarations, MSDS, certificates of analysis, GMP certificates and other such documentation, in addition to the scientific studies or data that may be submitted to specifically address the safety, trade and efficacy criteria.

The online application form contains fields to assist applicants in entering the information required to generate the information list.

Note: Information lists are published, including details of the holders of the information. Applicants should take care not to inadvertently divulge confidential commercial information (CCI) when creating the list.

Electronic label (e-Label)

The APVMA must have regard to certain matters or details in order to satisfy itself that a label meets the labelling criteria and approve the label (sections 5D and 14 of the Agvet Code). Applicants must use the e-label template to submit the label details that the APVMA must take into account.

Introduction to preparing a label and the label approval process provides more detailed information.

Pre-application assistance

Pre-application assistance is designed to give applicants advice on the information and module requirements of an application prior to submission. It can also be used to obtain an appraisal on a trial protocol or for agreement on project plans for time shift applications.

Tier 1: $577.50
This tier is designed to support the early stages of preparing an application, such as guidance and clarification on the types of assessments necessary for the proposed application.

Tier 2: $962.50
This is used for technical advice to support a particular application and to give applicants greater confidence that their proposed submission will contain the relevant information to address the safety, efficacy and trade criteria.

Tier 3: $1,347.50 + $1,155 per additional module chosen
This advice level can include an appraisal of a specific study design and finalisation of project plans for time shift applications.

Rebate: In some circumstances, where a pre-application assistance fee was paid in relation to a proposed product application, your product application fee will be reduced by an amount prescribed in the Agvet Code Regulations.

Examples

Scenario 1: Extension to include a new non-food use

Objective

Application is made to extend the registration of a herbicide (currently registered for control for control of various woody weeds in pastures) to use as a herbicide to control the same woody weeds in Rights of way and industrial situations. There is no change to the application rate or target weeds.

Use pattern Situations Weeds controlled Rate Critical use comments/restraints
Existing use pattern Grazing pastures

Silver Wattle

Blackberry

African boxthorn

Hand Gun

500 mL/100 L of water

Spray when growth is active. Spray foliage to give full coverage of leaves and stems
Proposed use pattern Rights of way and industrial situations

Silver Wattle

Blackberry

African boxthorn

Knapsack

100 mL/20 L of water

Spray when growth is active. Spray foliage to give full coverage of leaves and stems

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate the product will continue to meet the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria particularly in relation to target crop safety (plant back period).

The following table examines each assessment module and provides an explanation of what modular assessments, levels, timeframe and associated fees are likely to apply to this extension. Modules 1, 11 and 12 are mandatory modules for this application. Considerations are necessary for this extension for Modules 2–10.

Module type Module level Timeframe Fee
1: Preliminary assessment 1.0 Up to 30 days $710
2: Chemistry No assessment required as the product is currently registered and there are no changes to the product formulation or packaging
3: Toxicology No assessment required as the product is currently registered and relevant health standards are already established
4: Toxicology—Poison scheduling No assessment required as the product is currently registered and relevant scheduling is established
5: Residues and trade No assessment required as the new use pattern is not for use in a food producing situation
6: Workplace health and safety Assessment is required. The proposed use by knapsack is expected to lead to a greater risk of exposure to that previously assessed
6.3 4 months $2 920
7: Environment The similarity of the two situations (directed spray in industrial situations and Rights of way as opposed to pastures) would be considered in terms of risk to the environment. If the risk to the environment is considered equivalent or less an environment module (and associated information) would not be required
8: Efficacy and safety Assessment of efficacy and target crop safety will be not be required, the product is expected to be effective in the new situation as it is applied in the same manner at the same rate to control the same weeds. Crop safety is not of a concern as the use pattern is limited to directed spray
9: Non-food trade No assessment required as ornamentals are not a non-food traded commodity
10: Special data No assessment required as the product does not contain any GMO’s
11: Finalisation 11.2 2 months $1 545
12: Limits of use If no new information was assessed under a technical assessment, a module 12 does not apply
Total   6 months $5 175

Scenario 2: Extension to include a new non-food use

Objective

Application is made to extend the registration of an insecticide (currently registered for control of plague locust in pasture and sorghum) to add control of plague locust and additional pests in forestry plantations. There is no change to formulation, application rate or method of application.

  Use Pest Rate Critical use comments/restraints
Existing use pattern Pasture and sorghum Australian Plague Locust Aerial application 6.25 mL/ha Spray when growth is active. Spray foliage to give full coverage of leaves and stems
Proposed use pattern Forestry plantations (Eucalyptus and Pinus)

Australian Plague Locust

Spur throated locust

Wingless grasshopper

Aerial application 6.25 mL/ha Apply diluted with water to a minimum  of 20L/ha by air

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate the product will continue to meet the section 5 safety, efficacy and trade criteria particularly in relation to efficacy and target crop safety.

The following table examines each assessment module and provides an explanation of what modular assessments, levels, timeframe and associated fees are likely to apply to this extension. Modules 1, 11 and 12 are mandatory modules for this application. Considerations are necessary for this extension for Modules 2–10.

Module type Module level Timeframe Fee
1: Preliminary assessment 1.0 Up to 30 days $710
2: Chemistry No assessment required as the product is currently registered and there are no changes to the product formulation or packaging
3: Toxicology No assessment required as the product is currently registered and relevant health standards are already established
4: Toxicology—Poison scheduling No assessment required as the product is currently registered and relevant scheduling is established
5: Residues and trade No assessment required as the label includes a restraint to prohibit grazing of the forest post application. The additional use is not considered to be a food producing situation
6: Workplace health and safety No assessment required as the exposure for mixing/loading and application is equivalent to that previously assessed for the pasture
7: Environment An environmental assessment is required due to change from broad acre to forestry situation. Consideration would be given to different exposure of non-target organisms including spray drift and run-off scenarios. required
7.2 7 months $7 315
8: Efficacy and safety Assessment of efficacy and target crop safety is required due to the extension to control additional pests in a new situation. Crop safety will need to be considered for the extension into forestry
8.1 6 months $2 370
9: Non-food trade No assessment required as forestry products are not a non-food traded commodity
10: Special data No assessment required as the product does not contain any GMO’s
11: Finalisation 11.2 2 months $1 545
12: Limits of use If no new information was assessed under a technical assessment, a module 12 does not apply
Total   9 months $12 400

Scenario 3: Extension to include a new non-food use (turf)

Objective

Application is made to extend the registration of a fungicidal treatment (currently registered for control of various fungal diseases in wheat) for use as fungicidal treatment for the control of an unrelated fungal  disease in turf.

Use pattern Use Pest Rate Critical use comments/restraints
Existing use pattern Wheat Stem Rust 500 mL Apply at first sign of disease. Ensure thorough coverage of stems and leaves
Proposed use pattern Turf Dollar Spot 60 mL/100 m2 in 20 L of water Spray when conditions are warm and humid. Apply second application 14–28 days later if conditions favour disease development

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate the product will continue to meet the section 5 safety, efficacy and trade criteria particularly in relation to efficacy and target crop safety.

The following table examines each assessment module and provides an explanation of what modular assessments, levels, timeframe and associated fees are likely to apply to this extension. Modules 1, 11 and 12 are mandatory modules for this application. Considerations are necessary for this extension for Modules 2–10.

Module type Module level Timeframe Fee
1: Preliminary assessment 1.0 Up to 30 days $710
2: Chemistry No assessment required as the product is currently registered and there are no changes to the product formulation or packaging
3: Toxicology No assessment required if the product has the relevant health standards already established
4: Toxicology—Poison scheduling No assessment required as the product is currently registered and relevant scheduling is established
5: Residues and trade No assessment required as there is to be no grazing or feeding of grass clippings to livestock or poultry, addressed by the inclusion of an appropriate label statement, the additional use would not be considered a food producing situation
6: Workplace health and safety A WHS assessment is required to consider the change in exposure to workers and the public (using playing fields and golf courses). Re-entry periods will be set, if applicable and the risks from exposure will be assessed
6.2 7 months $3 185
7: Environment The variation from cereals to turf (including golf courses and playing fields) will require consideration of the risk to the environment. The application rate is slightly increased and spray drift and run-off scenarios will be different to those considered for the broad acre situation.
7.2 7 months $7 315
8: Efficacy and safety Extension to a new situation to control new pests assess will require an efficacy and target crop safety assessment
8.1 6 months $2 370
9: Non-food trade No assessment required as forestry products are not a non-food traded commodity
10: Special data No assessment required as the product does not contain any GMO’s
11: Finalisation 11.2 2 months $1 545
12: Limits of use 12.0 N/A $460
Total   9 months $15 585

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If you want to extend the use of your product and a technical variation (Item 14) is required:

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