Example - Type 12, 15, 17 and 18 - Item 14 (Ag) - Scenario 9

Scenario 9: Variation of a critical comment in relation to a mandatory tank mix supporting the addition of a new weed species

Objective

An application is made to vary the label for a pre-emergence herbicide (trifluralin) to add a new weed and a mandatory tank mix (simazine) to the critical comments for lupins.

The applicant has provided additional data to demonstrate efficacy against brome grass and crop safety when the tank mix is used. The applicant has identified a simazine product which is registered for lupins at the proposed rate (1.1 kg/ha) with the same application rate and timing of application.

MRLs have been established for the existing registered products (both trifluralin and simazine) and there is no proposed change to WHPs, frequency or rate of application.

 

Crop

Weed

Rate

Critical comments

Current approved label statement

Lupins

Capeweed, turnip, radish, doublegee.

 

Suppression of annual rye grass, wild oats

1 L/ha

Spray between 4 weeks and just before sowing. Apply to bare moist soil and incorporate to a depth of 5 cm just prior sowing.

Proposed new label statement

Lupins

Capeweed, turnip, radish, doublegee.

 

Suppression of annual rye grass, wild oats

1 L/ha

Spray between 4 weeks and just before sowing. Apply to bare moist soil and incorporate to a depth of 5 cm just prior sowing.

Suppression of Brome grass

1 L/ha

plus

1.1 kg/ha 900 WG simazine product

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that product will continue to satisfy the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria following the variation to the critical comments.

An updated label reflecting the change in directions for use must be included in the application.

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 no change is proposed to the product chemistry.

3: Toxicology

No assessment required as the product is currently registered and relevant health standards have previously been established.

4: Toxicology—Poison scheduling

No assessment required as appropriate scheduling is already in place.

5: Residues and trade

No assessment required as there is no change to the rate, frequency or timing of application.

6: Work health and safety

Mixing and loading has been assessed for the individual products. An assessment of the synergism between the two actives is required. No new data would be required.

6.3

4 months

$3 913

7: Environment

An assessment is required to evaluate the environmental impact of the combination of products.

7.2

7 months

$7 659

8: Efficacy and Safety

An assessment is required to ensure the product will be effective and safe to use with the amended label directions. Data on the efficacy and safety of the product with the mandatory tank mix would be evaluated.

8.2

4 months

$1 950

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 GMOs.

11: Finalisation

11.1

3 months

$8 110

12: Limits on use (data protection)

12.0

N/A

$460

Total

 

10 months

$22 994

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