Example - Type 12, 15, 17 and 18 - Item 14 (Ag) - Scenario 6

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

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.

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 (Section 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. 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 appropriate scheduling is already in place.

5: Residues and trade

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.

5.4

4 months

$7 465

6: Work health and safety

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.

6.3

4 months

$3 913

7: Environment

An assessment is required as the cumulative exposure to the environment has increased. No additional information is required to conduct this assessment.

7.2

7 months

$7 659

8: Efficacy and safety

Assessment is required to ensure the change from 14 to 10 days is efficacious and safe to crops as claimed.

8.3

3 months

$1 160

9: Non-food trade

No assessment required as there are no changes to product risks to non-food trade.

10: Special data

No assessment required as neither the product nor the crop contain any genetically modified organisms.

11: Finalisation

11.1

3 months

$8 110

12: Limits on use (data protection)

12.0

N/A

$460

Total

 

10 months

$29 669

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