Example - Type 12, 15, 17 and 18 - Item 14 (Ag) - Scenario 8

Scenario 8: Variation of a critical comment in the directions for use table in relation to crop growth stage of application

Objective

An application is made to vary the label for a plant growth regulator to add a crop growth stage at which it can be safely applied in grapes. The frequency and rate of application are also changing.

 

Crop

Purpose

Rate

Critical comments

Current approved label statement

Table grapes

To promote early uniform colouring

15 mL/100 L water plus a suitable wetter

 

Apply when 5–30% of the berries are coloured.

 

Ensure thorough coverage of bunches although the foliage need not be completely covered.

Proposed new label statement

Table grapes

To promote early uniform colouring

15 mL/100 L water plus a suitable wetter

 

Apply when 5–30% of the berries are coloured (approximately 4 weeks prior to expected harvest).

 

Ensure thorough coverage of bunches although the foliage need not be completely covered.

To aid mechanical harvesting

50 mL /100 L plus a suitable wetter

Apply 7 days before expected harvest. Thorough coverage of upper and lower leaf surfaces is essential.

 

NOTE: Some leaf yellowing and leaf fall, which is not detrimental to vines, may occur.

Current withholding period:

Harvest: Do not harvest for four weeks after application.

Proposed withholding period:

Harvest: Do not harvest for seven days after application.

The applicant has provided data to demonstrate efficacy and crop safety when applied at the later growth stage, as well as new residues data to account for dual applications and the overall increased application rate and shorter WHP.

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

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.

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

An assessment is required to evaluate the new residues data and if necessary to account for an increased MRL, undertake a trade risk assessment.

5.2

8 months

$11 149

6: Work health and safety

An assessment is required to consider the increased frequency of exposure to workers, and for re-entry.

6.3

4 months

$3 913

7: Environment

An assessment is required as the exposure to the environment has increased. No additional information is required to conduct this assessment.

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. New data would be assessed to confirm crop safety at the later application stage.

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

 

11 months

$34 143

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