Examples – Type 14 – Item 14 (Ag): Scenario 3

Scenario 3: Application to vary a product formulation to substitute a solvent for a solvent in a schedule of the Poisons Standard

Objective

An applicant applies to vary the formulation of a registered insecticide to substitute one excipient solvent for another. The new solvent is a scheduled poison (schedule 6 of the Poison Standard) and is known to have health risks to humans that must be considered. A new constituent statement, safety directions, first aid instructions and re-entry periods may be required. The product does not have any registered aquatic uses, so an environmental assessment is not required.

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that if the formulation is changed, the product will continue to satisfy the safety, efficacy (including crop safety) and trade criteria.

As the formulation change will result in changes to the relevant label particulars, an updated label 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. Considerations are necessary for Modules 2–10 for this variation.

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

1.0

Up to 1 month

$902

2: Chemistry

Assessment is required of the chemistry and manufacturing aspects of the new formulation.

2.3

6 months

$1 954

3: Toxicology

An assessment may be required to assess changes in toxicity related to the formulation change.

3.3

5 months

$4 050

4: Toxicology – Poison scheduling

No assessment required if appropriate scheduling is in place for the new solvent.

5: Residues and trade

No assessment required as there are no changes to product residue risks.

6: Work health and safety

Assessment is required to assess changes to health and safety risks related to product handling and usage and set new safety directions and re-entry periods.

6.3

4 months

$3 913

7: Environment

No assessment required as there is no expected change to environmental risk.

8: Efficacy and safety

Assessment is required of the impact of changes to product formulation on the crop safety and efficacy of the product.

8.3

3 months

$1 160

9: Non-food trade

No assessment required as the proposed formulation changes will not alter risks related 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

N/A

$460

Total

 

9 months

$20 549

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Examples