Example - Type 12, 15, 17 and 18 - Item 14 (Ag) - Scenario 7

Scenario 7: Variation of a crop safety statement

Objective

An application is made to vary the label for an insecticide to amend a crop safety statement that advises of russeting in apples following the application of an insecticide under certain climatic conditions.

The applicant has provided additional data to demonstrate that when this product is used according to the label directions on a variety of apply types, the russeting is restricted to one variety (Golden Delicious) and requests an update of this warning on the product label. The timing, frequency and rate of application are not changing.

Current approved label statement

Proposed new label statement

This product may cause russeting of apples when applied in conditions of high humidity.

This product may cause russeting of Golden Delicious apples when applied in conditions of high humidity.

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 the proposed changes will not impact on the previous residues assessment.

6: Work health and safety

No assessment required as the product is currently registered and the rate and method of application is unchanged.

7: Environment

No assessment required as the product is currently registered and the rate, method and timing of application is unchanged.

8: Efficacy and safety

An assessment is required to ensure the product will be effective and safe to use with the amended label directions. New data would be assessed to confirm target crop safety.

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

11.2

2 months

$3 090

12: Limits on use (data protection)

12.0

N/A

$460

Total

 

6 months

$6 402

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Examples