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