Example - Type 12, 15, 17 and 18 - Item 14 (Ag) - Scenario 3

Scenario 3: Variation of application method—air blast to hand held

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.

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. 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

No assessment required as the rates is the same as the registered uses and there is no change to MRLs or WHPs.

6: Work health and safety

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.

6.3

4 months

$3 913

7: Environment

No assessment required as the changed application method does not increase the environmental risk that has already been assessed for the product.

8: Efficacy and safety

No assessment required as the changed application method does not change the risk already assessed for the product.

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

11.2

2 months

$3 090

12: Data protection

Not required if there is no new data submitted.

Total

 

6 months

$7 905

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