I want to vary the use of an agricultural product to include a new use, new application method, or new use instructions within an existing crop or situation and a technical assessment is required (Item 14)

1. Legislation

1.1. Framework

The Agricultural and Veterinary Chemicals (Administration) Act 1992 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 1994 contains the constitutional and other legal provisions that enable the Agvet Code to have effect.

The Agricultural and Veterinary Chemicals Code Act 1994, 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.

1.2. 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 (Agvet Code, s 29).

The Agvet Code, s 20(1)(c) 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

(i) the constituents of the chemical product
(ii) the concentration of each constituent of the chemical product
(iii) if possible, the composition and purity of each active constituent of the chemical product
(iv) the formulation type for the chemical product
(v) the net contents for the chemical product
(vi) identifying information for the holder of the registration of the chemical product
(vii) the name of each manufacturer of the chemical product
(viii) the address of each site at which the chemical product is manufactured by the manufacturer
(ix) the date of entry of these particulars in the Register of Chemical Products
(x) identifying information for any nominated agent for the registration.

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

b)

(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
(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 sub-regulation (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.

Conditions are:

a) the conditions prescribed by the regulations (whether or not the conditions are prescribed at the time the constituent, product or label is approved or registered); and
b) any conditions imposed on the approval or registration as the APVMA thinks appropriate.

1.3. 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:

• Safety (section 5A).

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 s 5A criteria, the APVMA considers chemistry and manufacture, health (including poison scheduling and work health and safety), residues, environment and target safety.

• Efficacy (section 5B)

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.

• Trade (section 5C)

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.

• Labelling (section 5D)

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.

1.4. Application requirements

The Agvet Code, s 8A provides the definition of 'meets the application requirements'.

The Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014, Parts 2 and 4, sets out the information that must be contained in, or accompany an, application under the Agvet Code.

1.5. Guidelines

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 that fall under this, for example:

• module descriptors
• data guidelines
• limits on use of information.

1.6. Applications may be withdrawn

The Agvet Code, s 8D 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.

2. Timeframe and fees

This application type is subject to an extended assessment period if an Agvet Code s 159 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.

2.1. Pre-application assistance

Pre-application assistance is available to give applicants advice on the requirements of an application before submission.

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

Applications for extension of use must satisfy the statutory criteria of safety, efficacy and trade. Depending on the extension being sought, one or more of the following technical module types (but Preliminary Assessment, Finalisation and Data Protection) 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.

Module	Timeframe	Fee
Preliminary Assessment	Up to 1 month	$902
Chemistry	No assessment required as there has been no change to formulation or packaging
Poison Scheduling	No assessment required if appropriate scheduling is already in place
Residues 2 or Residues 4 (if required)	8 months 4 months	$11 149 $7 465
Health 56: Work health and safety (if required)	4 months	$4 000
Environment 2 or Environment 3 (if required)	7 months 4 months	$7 659 $2 979
Efficacy and Safety 2 or 3 (if required)	4 months 3 months	$1 950 $1 160
Non-food Trade (if required)	6 months	$1 175
Special Data 3 (if required)	Assessment required if the product or the target crop contain genetically modified organisms
	7 months	Nil
Finalisation 1 or 2	3 months 2 months	$8 110 $3 090
Data protection	N/A	$460

2.1.1. Examples

Scenario	Modules	Timeframe	Fee
Scenario 1: Addition of a new pest within an existing crop	Preliminary Assessment, Efficacy 2, Finalisation 2 and Limits on Use	6 months 9 months (extended assessment period)	$6 402
Scenario 2: New application method (ground rig to aerial application)	Preliminary Assessment, Residues 4, Health 5, Environment 3, Efficacy and Safety 3, Finalisation 1, Limits on Use	7 months 10 months (extended assessment period)	$24 989
Scenario 3: New application method (orchard air blast to handheld sprayer)	Preliminary Assessment, Health 5, Finalisation 2	6 months 8 months (extended assessment period)	$7 905
Scenario 4: Variation in application rate in existing situation in a food producing crop	Preliminary Assessment, Residues 3 or 4, Health 2, Environment 2, Efficacy and Safety 3, Finalisation 1, Limits on Use	11 months 15 months (extended assessment period)	$33 353
Scenario 5: Variation in application rate in existing situation in a non-crop area	Preliminary Assessment, Health 5, Environment 3, Efficacy and Safety 2, Finalisation 1, Limits on Use	10 months 14 months (extended assessment period)	$22 994
Scenario 6: Variation to amend the frequency of application	Preliminary Assessment, Residues.3 or 4, Health 5, Environment 2, Efficacy 3, Finalisation 1, Limits on Use	10 months 14 months (extended assessment period)	$29 669
Scenario 7: Variation to amend a crop safety statement	Preliminary Assessment, Efficacy 2, Finalisation 2, Limits on Use	6 months 8 months (extended assessment period)	$6 402
Scenario 8: Variation in relation to a crop growth stage	Preliminary Assessment, Residues.2, Health.5, Environment.2, Efficacy 2, Finalisation 1, Limits on Use	11 months 14 months (extended assessment period)	$34 143
Scenario 9: Variation of critical comments to include a new weed species and mandatory tank mix	Preliminary Assessment, Health 5, Environment 2 or 3, Efficacy 2, Finalisation 1, Limits on Use	10 months 14 months (extended assessment period)	$22 994

3. Modules

3.1. 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.

3.2. Non-food Trade

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

3.3. Residues and Trade

Residues assessment includes the establishment of residues definition, maximum residue limits (MRLs), and withholding periods (WHPs), and the assessment of the trade implications including the establishment of any export intervals (EIs).

There are general guidelines for both Residues Part 5A and Overseas trade Part 5B available and you should consider any of the specific guidelines which relate to your product type or extension of use.

The APVMA may decide that a residues assessment is not required when an agricultural chemical is unlikely to enter the food chain through the proposed use pattern.

This would apply to situations such as termiticides, pool products and turf products where grazing of turf and feeding of grass clippings to livestock is not permitted and products for control of urban pests where contact with food is not expected.

3.4. Health

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

3.5. 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 assessment is required.

3.6. 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 germination, effects of residues, organoleptic tests or pharmacologic studies.

The APVMA has developed the module descriptors to provide guidance as to the modules that will apply for different types of applications. The APVMA will have regard to this document, but may depart from it, when determining which modules are necessary on a case-by-case basis. 

Adding a new use, new application methods or new use instructions to existing crops or situations must satisfy the safety (section 5A), efficacy (section 5B) and trade (section 5C) criteria, as set out in the Agvet Code, for the variation. However, the amount of new information or data required will vary depending upon how significant the change is, and what new assessments are necessary.

3.6.1. Residues 2 module

Residues 2 applies to applications requiring assessment of the residues and trade implications for a crop producing a major export food commodity group with risks of residues and a change to established MRLs is required.

A variation where consideration of MRLs and WHPs and/or trade implications are required for:

1. a food crop that produces a major export food commodity group and finite residues are expected; or
2. six or more food crops or crop groups.

Module	Timeframe	Fee
Residues 2	8 months	$11 149

3.6.2. Residues 3 module

Residues 3 applies to applications requiring assessment of the residues and trade implications for a crop producing a major export food commodity group where finite residues are not expected or where no change to established MRLs is required, for:

1. a food crop that produces a major export food commodity group; or
2. four to six crops or crop groups.

Module	Timeframe	Fee
Residues 2	8 months	$11 149

3.6.3. Residues 4 module

Residues 4 applies to variations of WHPs and, where necessary, the establishment of MRLs and the assessment of trade implications of an application to extend use to 1 to 3 food crops or crops producing feed for food-producing species (not including major export food commodity groups).

1. 1 to 3 food crops or crop groups; and
2. where trade consultations are not required.

Module	Timeframe	Fee
Residues 4	4 months	$7 465

3.6.4. Health 5

Health 5 is required when the application involves a new application method, a change in use pattern to include a new crop group or situation, or reassessment of user safety directions, re-entry or re-handling statements for more than one scenario, but where no assessment of the toxicity of the formulation is required.

Module	Timeframe	Fee
Health 5	4 months	$4 000

3.6.5. Environment 2

Environment 2 applies to variations that involve:

(i) a new crop in a new crop group or new situation; or
(ii) an increase in application rate of frequency for an existing use pattern.

Module	Timeframe	Fee
Environment 2	7 months	$7 659

3.6.6. Environment 3

Environment 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).

A variation to:

1. add a new crop to an existing crop group
2. add a use in the home, home garden, swimming pool or spa
3. add a use in buildings not used in animal production (eg warehouses, glasshouses, offices)
4. change a formulation resulting in altered environmental risk.

Module	Timeframe	Fee
Environment 3	4 months	$2 979

3.6.7. Efficacy and Safety 2

Efficacy and Safety 2 is required for extensions to a use where data will be assessed.

It applies for variations of a product that involve:

1. a new pest or new crop within the same crop group or situation with the same general use pattern as an existing registered product;
2. a new minor use with the same general use pattern as an existing registered product;
3. new domestic or home garden use;
4. an increase in application rate or frequency for an existing use pattern; or
5. new application method or equipment.

Module	Timeframe	Fee
Efficacy and Safety 2	4 months	$1 950

3.6.8. Efficacy and Safety 3

Efficacy and Safety 3 is required for extension to use where you are seeking to establish equivalence to the same use on another registered product and where the use of that registered product is not subject to limits on use of information (bioequivalence or scientific argument only).

A variation of a product that involves:

1. a formulation change; or
2. where only bioequivalence (including scientific argument) is required to demonstrate the efficacy and crop safety compared to a currently registered product where the product is defined as similar to an existing registered product; or
3. a variation that is not referred to above and that is not an item 12 variation.

Module	Timeframe	Fee
Efficacy and Safety 3	3 months	$1 160

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

1. residues in wool and fibre, or
2. genetically modified produce.

Module	Timeframe	Fee
Non-food Trade	6 months	$1 175

3.7. 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) and require a Special Data assessment.

Specifically, you should consider the following guidelines:

• Products of gene technology
• Products of nanotechnology

Module	Timeframe	Fee
Special Data 3	7 months	$Nil

3.8. Module 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.

Finalisation 2 is included when fewer than 3 technical modules (modules other than Preliminary Assessment, Finalisation or Limits on Use), apply and Finalisation 1 is included when 3 or more technical modules apply.

3.8.1. Finalisation 1

A variation where 3 or more modules other than Preliminary Assessment, Finalisation or Limits on Use apply.

Module	Timeframe	Fee
Finalisation 1	3 months	$8 110

3.8.2. Finalisation 2

A variation where fewer than 3 modules other than Preliminary Assessment, Finalisation or Limits on Use apply.

Module	Timeframe	Fee
Finalisation 2	2 months	$3 090

3.9. Limits on use of information

Limites on use 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	Timeframe	Fee
Limits on use	N/A	$460

4. What you need to provide

4.1. Completed online application form

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

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

4.2. The application fee

You may choose to:

• pay the total fee on submission or
• pay the preliminary assessment fee of $902 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).

4.3. 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.

4.4. 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 (Agvet Code, ss 5D and 14). 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.

4.5. Supporting information

The application must contain, or be accompanied by, information relevant to the whether the chemical product meets the safety and efficacy criteria, but only to the extent that the variation proposed affects whether the product meets the safety, efficacy and trade criteria. Applicants should include an explanation of why they believe supporting information is not required if they choose not to provide it with the application.

Relevant data for module levels—agricultural chemical products sets out the data that may be relevant to particular assessment modules detailed in the Agvet Regulations. This list is not exhaustive and is only intended to provide you with guidance in putting your application together.

• Chemistry
  Detailed data guidelines for chemistry and manufacture are available in Part 2
• Health
  Detailed data guidelines for toxicology are available in Part 3
• Residues and Trade
  Detailed data guidelines for residues are in Part 5A
  Detailed data guidelines for trade are in Part 5B
• Health
  Detailed data guidelines for occupational health and safety are in Part 6
• Environment
  Detailed data guidelines for environment are in Part 7
• Efficacy and Safety
  Detailed data guidelines for efficacy and safety are in Part 8
• Trade
  Detailed data guidelines for trade are in Part 5B
• Non-food Trade
  For applications referred to under Non-food trade in the module descriptors, data specifically relevant to the trade risk may be submitted
• Special Data Assessment
  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, may be submitted

4.6. Pre-application assistance

Pre-application assistance is available to give applicants advice on the requirements of an application before submission.

To meet the application requirements you will need to provide:

• a completed online application form
• the application fee plus any amount that is due to the APVMA
• supporting information to demonstrate the product once varied 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 on use)
• e-Label.

5. Examples

5.1. Scenario 1: Addition of a new pest within the same crop

5.1.1. Objective

An application is made to extend an insecticide product currently registered to control redlegged earth mite in silverbeet to include a claim for the control of two-spotted mite in silverbeet. The application method, timing and frequency are the same.

	Crop	Insect	Rate	Critical use comments/restraints
Existing use pattern	Silverbeet	Red legged earth mite	140 or 300 mL per ha	Use higher rate for severe infestations. Headlands and vegetation surrounding the crop may also need to be treated.
Proposed use pattern	Silverbeet	Red legged earth mite   Two-spotted mite	140 or 300 mL per ha	Use higher rate for severe infestations. Headlands and vegetation surrounding the crop may also need to be treated.

5.1.2. 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 when used to control two-spotted mites.

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. Preliminary Assessment, Finalisation and Data Protection are mandatory modules for this application.

Module	Timeframe	Fee
Preliminary assessment	Up to 1 month	$902
Chemistry	No assessment required as the product is currently registered and there are no changes to the product formulation or packaging.
Health	No assessment required as the product is currently registered and relevant health standards are already established, and the proposed rate, method and timing of application is the same.
Poison scheduling	No assessment required as the product is currently registered and relevant scheduling is established.
Residues and Trade	No assessment required as the target crop and application rate proposed is the same as the registered uses and there is no change to the WHPs.
Environment	No assessment required as the product is currently registered and the proposed rate, method and timing of application is the same.
Efficacy and Safety 2	Assessment of efficacy will be necessary for extension to a new pest in silverbeet. Target crop safety has already been established for this product in silverbeet and the rate of application is not changing.
	4 months	$1 950
Non-food Trade	No assessment required as silverbeet is not a non-food traded commodity.
Special Data	No assessment required as neither the product nor the crop contain any GMOs.
Finalisation 2	2 months	$3 090
Data protection	N/A	$460
Total	6 months	$6 402

5.2. Scenario 2: Variation of application method – ground to aerial

5.2.1. Objective

An application is made to vary the product registration for a fungicide to include aerial application.

General instructions (existing)	General instructions (proposed)
Ground rig application: use a total volume of 50–200 L/ha as a fine spray (ie a droplet size of 100 to 200 microns).	Ground rig application: use a total volume of 50–200 L/ha as a fine spray (ie a droplet size of 100 to 200 microns).   Aerial application: Use a minimum spray volume of 20 L/ha. If possible, spray in a cross wind. Apply as a spray of 100–150 microns VMD.

The applicant sought Pre-Application Assistance to get guidance on the assessments and modules that would be required.

A work health and safety assessment is required to reassess exposure to users and bystanders from mixing and loading, and spray drift. Re-entry does not need to be reconsidered because the rate and frequency of application is not changing.

An environmental risk assessment and a residues and trade risk assessment are required to evaluate the spray drift implications of the change from boom spray to aerial application.

An efficacy and crop safety assessment is required to show that application by air with a higher concentrate spray is equivalent to application by ground rig. The spray volume for aerial application is lower than for ground application, so the applicant needs to show that the crop coverage is adequate for the product to be effective. The applicant submits bioequivalence data showing a comparison between the two application methods.

5.2.2. 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 when used aerially.

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. Preliminary Assessment, Finalisation and Limits on Use modules are mandatory for this application.

Module	Timeframe	Fee
Preliminary assessment	Up to 1 month	$902
Chemistry	No assessment required as the product is currently registered and there are no changes to the product formulation or packaging.
Poison Scheduling	No assessment required as the product is currently registered and relevant scheduling is established.
Residues and Trade	An assessment is required to consider the changed spray drift risks to the trade of livestock commodities as a result of the change in application method. A limited assessment is appropriate because endpoints have already been established.
	4 months	$7 465
Health	An assessment is required to ensure product handling details adequately minimise risk to the safety of users, workers or bystanders.
	4 months	$4 000
Environment	An assessment is required to consider the changed risks to the environment as a result of the change in application method. A limited assessment is appropriate because endpoints have already been established.
	4 months	$2 979
Efficacy and Safety 3	An assessment is required to determine if aerial application is as effective and safe as ground application.
	3 months	$1 160
Non-food Trade	No assessment required as there are no changes to non-food trade.
Special Data	No assessment required as neither the product nor the crop contain any GMOs.
Finalisation 1	3 months	$8 110
Data protection	N/A	$460
Total	7 months	$25 076

5.3. Scenario 3: Variation of application method – air blast to hand held

5.3.1. Objective

An application is made to vary the product registration for a fungicide used on stone fruit by air-blast spray to add use by hand-held sprayer.

	Rate	Critical comments
Current label	100–150 mL /100 L water (dilute spray)	Apply by air-blast sprayer or equivalent equipment.   Apply as a thorough foliar spray to the point of run off.
Proposed label	100–150 mL /100 L water (dilute spray)   Or   15–22.5 mL /15 L water	Apply by air-blast sprayer or equivalent equipment.   Apply as a thorough foliar spray to the point of run off.   Spot spraying: Apply with low-pressure hand held sprayer. Thoroughly wet all foliage.

5.3.2. 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 when used by hand-held sprayer.

A work health and safety assessment is required to reassess exposure to users. Re-entry does not need to be reconsidered because the rate and frequency of application is not changing.

An efficacy and safety assessment is not required (unlike scenario 2 above) as the change in application method is not expected to change the efficacy or safety of the product.

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. Preliminary Assessment, Finalisation and Limits on Use modules are mandatory for this application.

Module	Timeframe	Fee
Preliminary assessment	Up to 1 month	$902
Chemistry	No assessment required as the product is currently registered and there are no changes to the product formulation or packaging.
Poison Scheduling	No assessment required as the product is currently registered and relevant scheduling is established.
Residues and Trade	No assessment required as the rates is the same as the registered uses and there is no change to MRLs or WHPs.
Health 5	The exposure of a user applying the product by handheld equipment is different to that from air blast equipment. An assessment is required to ensure product handling details adequately minimise risk to the safety of users.
	4 months	$4 000
Environment	No assessment required as the changed application method does not increase the environmental risk that has already been assessed for the product.
Efficacy and Safety	No assessment required as the changed application method does not change the risk already assessed for the product.
Non-food Trade	No assessment required as there are no changes to non-food trade.
Special Data	No assessment required as neither the product nor the crop contain any GMOs.
Finalisation 2	2 months	$3 090
Data protection	Not required if there is no new data submitted.
Total	6 months	$7 991

5.4. Scenario 4: Variation to increase application rate in a food producing crop

5.4.1. Objective

An application is made to increase the rate of application for an insecticide product for the control of aphids in wheat. The product is currently used with a non-ionic surfactant. It is proposed that the higher rate of active does not require the addition of a surfactant to be effective.

	Crop	Insect	Rate	Critical use comments
Existing use pattern	Wheat	Aphids	15 g/ha plus a non-ionic surfactant at label rates	Apply at the first sign of the pest. This product will take 3–4 days to reach full effectiveness.
Proposed use pattern	Wheat	Aphids	30 g/ha	Apply at the first sign of the pest. This product will take 3–4 days to reach full effectiveness.

The current withholding period for harvest and grazing is four weeks. The applicant proposes that these withholding periods do not need to change. 

5.4.2. 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 when used at the higher rate.

To support the higher rate of application, the applicant has provided efficacy, crop safety data to show that the product when used proposed directions for use has equivalent efficacy and crop safety to when the product is used with the existing directions. Residues data has also been submitted.

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. Preliminary Assessment, Finalisation and Limits on Use modules are mandatory for this application.

Module	Timeframe	Fee
Preliminary assessment	Up to 1 month	$902
Chemistry	No assessment required as the product is currently registered and there are no changes to the product formulation or packaging.
Poison scheduling	No assessment required as the product is currently registered and relevant scheduling is established.
Residues 2	An assessment is required to consider the potential for residue in wheat grain, straw and forage for the use of the product from the higher rate. Wheat is a major export commodity so Residues 2 is appropriate if a change to the established MRL for wheat grain may be required. A public consultation on the implications to international trade will be required should the MRL need to increase.
	8 months	$11 149
Health 5	A work health and safety assessment is required for use of the product at the higher rate.
	4 months	$4 000
Environment 2	An environmental assessment is required for use of the product at the higher rate.
	7 months	$7 659
Efficacy and Safety 3	An efficacy and safety assessment is required for use of the product at the higher rate.
	3 months	$1 160
Non-food Trade	Not required.
Special Data	The product is not a genetically modified organism so this assessment is not required.
Finalisation 1	3 months	$8 110
Limits on use (data protection)	N/A	$460
Total	11 months	$33 440

5.5. Scenario 5: Variation to application rate of a product in a non-food producing situation

5.5.1. Objective

An application is made to increase the application rate for a herbicide used to control broadleaf weeds in non-crop areas from 0.5–1 L/ha to 0.5–2.5 L/ha in order to change a claim of weed suppression to weed control. The applicant has only provided efficacy data to support the application in relation to the new claim. The current label has a grazing WHP of do not graze treated areas and the holder does not propose to change this.

5.5.2. Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that product’s capacity to meet the safety (Agvet Code, s 5A) criterion will not be affected by the increased application rate.

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. Preliminary Assessment, Finalisation and Limits on Use modules are mandatory for this application.

Module	Timeframe	Fee
Preliminary assessment	Up to 1 month	$902
Chemistry	No assessment required as the product is currently registered and there are no changes to the product formulation or packaging.
Poison Scheduling	No assessment required as appropriate scheduling is already in place.
Residues and Trade	No assessment required as the increased application rate is related to a non-food use.
Health 5	An assessment is required to consider the increased exposure due to the higher application rates. No additional information is required to conduct this assessment.
	4 months	$4 000
Environment 2	An assessment is required as the rate of application is higher than rates previously considered for the product. No additional information is required to conduct this assessment.
	7 months	$7 659
Efficacy and Safety 2	An assessment is required to ensure the proposed rate and instructions for use control weeds as claimed.
	4 months	$1 950
Non-food Trade	No assessment required as the changed use is not related to a non-food traded commodity.
Special Data	No assessment required as neither the product nor the crop contain any GMOs.
Finalisation 1	3 months	$8 110
Limits on use (data protection)	N/A	$460
Total	10 months	$23 081

5.6. Scenario 6: Variation to increase the frequency of application of a product

5.6.1. Objective

An application is made to increase the frequency of application of a fungicide product used to control fungal disease in cucurbits and walnuts from every 14 days to every 10 days. The applicant has provided efficacy and crop safety data, showing the product used at 10 day intervals is equivalent in terms of crop safety and efficacy to the product being used at 14 day intervals. Residues data has also been submitted to support the application.

5.6.2. Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that product’s capacity to meet the safety (Agvet Code, s 5A) criterion will not be affected by the increase in frequency and/or number of applications.

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. Preliminary Assessment, Finalisation and Limits on Use modules are mandatory for this application.

Module	Timeframe	Fee
Preliminary assessment	Up to 1 month	$902
Chemistry	No assessment required as the product is currently registered and there are no changes to the product formulation or packaging.
Poison Scheduling	No assessment required as appropriate scheduling is already in place.
Residues 4	An assessment is required to assess the change in residues resulting from the change in use pattern. Cucurbits and walnuts are not a major export commodity.
	4 months	$7 465
Health 5	An assessment is required to consider the increased frequency of exposure to workers, and for re-entry. Both ground boom and air blast application methods need to be considered. No additional information is required to conduct this assessment.
	4 months	$4 000
Environment 2	An assessment is required as the cumulative exposure to the environment has increased. No additional information is required to conduct this assessment.
	7 months	$7 659
Efficacy and Safety 3	Assessment is required to ensure the change from 14 to 10 days is efficacious and safe to crops as claimed.
	3 months	$1 160
Non-food Trade	No assessment required as there are no changes to product risks to non-food trade.
Special Data	No assessment required as neither the product nor the crop contain any genetically modified organisms.
Finalisation 1	3 months	$8 110
Limits on use (data protection)	N/A	$460
Total	10 months	$29 752

5.7. Scenario 7: Variation of a crop safety statement

5.7.1. Objective

An application is made to vary the label for an insecticide to amend a crop safety statement that advises of russeting in apples following the application of an insecticide under certain climatic conditions.

The applicant has provided additional data to demonstrate that when this product is used according to the label directions on a variety of apply types, the russeting is restricted to one variety (Golden Delicious) and requests an update of this warning on the product label. The timing, frequency and rate of application are not changing.

Current approved label statement	Proposed new label statement
This product may cause russeting of apples when applied in conditions of high humidity.	This product may cause russeting of Golden Delicious apples when applied in conditions of high humidity.

5.7.2. Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that product will continue to satisfy the safety (section 5A), efficacy (section 5B) and trade (section 5C) criteria, as set out in the Agvet Code, following the variation to the critical comments.

An updated label reflecting the change in directions for use must be included in the application.

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. Preliminary Assessment, Finalisation and Limits on Use modules are mandatory for this application.

Module	Timeframe	Fee
Preliminary assessment	Up to 1 month	$902
Chemistry	No assessment required as the product is currently registered and no change is proposed to the product chemistry.
Poison Scheduling	No assessment required as appropriate scheduling is already in place.
Residues and trade	No assessment required as the proposed changes will not impact on the previous residues assessment.
Health	No assessment required as the product is currently registered and the rate and method of application is unchanged.
Environment	No assessment required as the product is currently registered and the rate, method and timing of application is unchanged.
Efficacy and Safety 2	An assessment is required to ensure the product will be effective and safe to use with the amended label directions. New data would be assessed to confirm target crop safety.
	4 months	$1 950
Non-food Trade	No assessment required as there are no changes to product risks to non-food trade.
Special Data	No assessment required as neither the product nor the crop contain any GMOs.
Finalisation 2	2 months	$3 090
Limits on use (data protection)	N/A	$460
Total	6 months	$6 402

5.8. Scenario 8: Variation of a critical comment in the directions for use table in relation to crop growth stage of application

5.8.1. Objective

An application is made to vary the label for a plant growth regulator to add a crop growth stage at which it can be safely applied in grapes. The frequency and rate of application are also changing.

	Crop	Purpose	Rate	Critical comments
Current approved label statement	Table grapes	To promote early uniform colouring	15 mL/100 L water plus a suitable wetter	Apply when 5–30% of the berries are coloured.   Ensure thorough coverage of bunches although the foliage need not be completely covered.
Proposed new label statement	Table grapes	To promote early uniform colouring	15 mL/100 L water plus a suitable wetter	Apply when 5–30% of the berries are coloured (approximately 4 weeks prior to expected harvest).   Ensure thorough coverage of bunches although the foliage need not be completely covered.
		To aid mechanical harvesting	50 mL /100 L plus a suitable wetter	Apply 7 days before expected harvest. Thorough coverage of upper and lower leaf surfaces is essential.   NOTE: Some leaf yellowing and leaf fall, which is not detrimental to vines, may occur.

5.8.1.1. Current withholding period:

Harvest: Do not harvest for four weeks after application.

5.8.1.2. Proposed withholding period:

Harvest: Do not harvest for seven days after application.

The applicant has provided data to demonstrate efficacy and crop safety when applied at the later growth stage, as well as new residues data to account for dual applications and the overall increased application rate and shorter WHP.

An updated label reflecting the change in directions for use must be included in the application.

5.9. Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that product will continue to satisfy the safety (section 5A), efficacy (section 5B) and trade (section 5C) criteria, as set out in the Agvet Code, following the variation to the critical comments.

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. Preliminary Assessment, Finalisation and Limits on Use modules are mandatory for this application.

Module	Timeframe	Fee
Preliminary assessment	Up to 1 month	$902
Chemistry	No assessment required as the product is currently registered and no change is proposed to the product chemistry.
Poison Scheduling	No assessment required as appropriate scheduling is already in place.
Residues 2	An assessment is required to evaluate the new residues data and if necessary to account for an increased MRL, undertake a trade risk assessment.
	8 months	$11 149
Health 3	An assessment is required to consider the increased frequency of exposure to workers, and for re-entry.
	4 months	$4 000
Environment 2	An assessment is required as the exposure to the environment has increased. No additional information is required to conduct this assessment.
	7 months	$7 659
Efficacy and Safety 2	An assessment is required to ensure the product will be effective and safe to use with the amended label directions. New data would be assessed to confirm crop safety at the later application stage.
	4 months	$1 950
Non-food Trade	No assessment required as there are no changes to product risks to non-food trade.
Special Data	No assessment required as neither the product nor the crop contain any GMOs.
Finalisation 1	3 months	$8 110
Limits on use (data protection)	N/A	$460
Total	11 months	$34 230

5.10. Scenario 9: Variation of a critical comment in relation to a mandatory tank mix supporting the addition of a new weed species

5.10.1. Objective

An application is made to vary the label for a pre-emergence herbicide (trifluralin) to add a new weed and a mandatory tank mix (simazine) to the critical comments for lupins.

The applicant has provided additional data to demonstrate efficacy against brome grass and crop safety when the tank mix is used. The applicant has identified a simazine product which is registered for lupins at the proposed rate (1.1 kg/ha) with the same application rate and timing of application.

MRLs have been established for the existing registered products (both trifluralin and simazine) and there is no proposed change to WHPs, frequency or rate of application.

	Crop	Weed	Rate	Critical comments
Current approved label statement	Lupins	Capeweed, turnip, radish, doublegee.   Suppression of annual rye grass, wild oats	1 L/ha	Spray between 4 weeks and just before sowing. Apply to bare moist soil and incorporate to a depth of 5 cm just prior sowing.
Proposed new label statement	Lupins	Capeweed, turnip, radish, doublegee.   Suppression of annual rye grass, wild oats	1 L/ha	Spray between 4 weeks and just before sowing. Apply to bare moist soil and incorporate to a depth of 5 cm just prior sowing.
		Suppression of Brome grass	1 L/ha plus 1.1 kg/ha 900 WG simazine product

5.10.2. Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that product will continue to satisfy the safety (section 5A), efficacy (section 5B) and trade (section 5C) criteria, as set out in the Agvet Code, following the variation to the critical comments.

An updated label reflecting the change in directions for use must be included in the application.

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. Preliminary Assessment, Finalisation and Limits on Use modules are mandatory for this application.

Module	Timeframe	Fee
Preliminary assessment	Up to 1 month	$902
Chemistry	No assessment required as the product is currently registered and no change is proposed to the product chemistry.
Toxicology—Poison scheduling	No assessment required as appropriate scheduling is already in place.
Residues	No assessment required as there is no change to the rate, frequency or timing of application.
Health 3	Mixing and loading has been assessed for the individual products. An assessment of the synergism between the two actives is required. No new data would be required.
	4 months	$4 000
Environment 2	An assessment is required to evaluate the environmental impact of the combination of products.
	7 months	$7 659
Efficacy and Safety 2	An assessment is required to ensure the product will be effective and safe to use with the amended label directions. Data on the efficacy and safety of the product with the mandatory tank mix would be evaluated.
	4 months	$1 950
Non-food Trade	No assessment required as there are no changes to product risks to non-food trade.
Special Data	No assessment required as neither the product nor the crop contain any GMOs.
Finalisation 1	3 months	$8 110
Limits on use (data protection)	N/A	$460
Total	10 months	$23 081

6. Start an application

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

Start application

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