Example - Type 12, 15, 17 and 18 - Item 14 (Ag) - Scenario 4

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

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. 

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. Modules 1, 11 and 12 are mandatory modules for this application.

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

1.0

Up to 1 month

$902

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

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 module 5.2 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.

5.2

8 months

$11 149

6: Work health and safety

A work health and safety assessment is required for use of the product at the higher rate.  

6.3

4 months

$3 913

7: Environment

 

An environmental assessment is required for use of the product at the higher rate.  

7.2

7 months

$7 659

8: Efficacy and safety

An efficacy and safety assessment is required for use of the product at the higher rate.  

8.3

3 months

$1 160

9: Non-food trade

Not required.

10: Special data

The product is not a genetically modified organism so this assessment is not required.

11: Finalisation

11.1

3 months

$8 110

12: Limits on use (data protection)

12.0

N/A

$460

Total

 

11 months

$33 353

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Examples