Example - Type 12, 15, 17 and 18 - Item 14 (Ag) - Scenario 2

Scenario 2: Variation of application method—ground to aerial

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.

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. 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 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.

5.4

4 months

$7 465

6: Work health and safety

An assessment is required to ensure product handling details adequately minimise risk to the safety of users, workers or bystanders.

6.3

4 months

$3 913

7: 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.

7.3

4 months

$2 979

8: Efficacy and safety

An assessment is required to determine if aerial application is as effective and safe as ground application.

8.3

3 months

$1 160

9: Non-food trade

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

10: Special data

No assessment required as neither the product nor the crop contain any GMOs.

11: Finalisation

11.1

3 months

$8 110

12: Data protection

12.0

N/A

$460

Total

 

7 months

$24 989

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