Examples - Type 13 - Item 14 (Ag) - Scenario 2

Scenario 2: Variation to the shelf life from a change in storage conditions

Objective

An application is made to extend the current shelf life for an agricultural chemical product containing Bacillus thuringiensis from 12 months to two years. The current label includes the statement that the product “not be exposed to extremes of temperature”.

The applicant has undertaken real-time stability studies at 20°C which demonstrates that the product continues to meet the product specifications after two years in storage if stored at 20°C.

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that the extended shelf life and new storage conditions do not impact the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria.

An amended label is required with this application as the directions regarding the storage of the product (to be stored at 20°C) are to be changed.

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

A limited chemistry assessment is required to assess the data which is provided to demonstrate that the product continues to meet the product specifications after two years in storage at 20°C

2.3

6 months

$1 954

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 are no changes that would change residue

6: Work health and safety

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

7: Environment

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

8: Efficacy and safety

No assessment required as the registered product formulation and use pattern are unchanged and the infectivity of the formulation after two years in storage will be assessed under the chemistry module

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

8 months

$6 406

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Examples