Request for comments and suggestions–efficacy criteria

Background

The Agricultural and Veterinary Chemicals Code (Efficacy Criteria) Determination 2014 came into effect on 25 June 2014. This document outlines how the APVMA may be satisfied that the efficacy criteria have been met for agricultural and veterinary chemical products. Satisfaction may be based on product type or on demonstrated effectiveness.

The APVMA is looking at expanding the products where satisfaction of the efficacy criteria may be based on product type alone.

Efficacy is only one of the criteria the APVMA must consider when registering new or varying existing agricultural or veterinary chemical products. Product types where the efficacy criteria are deemed to have been met based on product type alone must still satisfy the safety and trade criteria.

Suitable product types may be those where efficacy is independent of formulation or formulation type or where suboptimal efficacy or inefficacy would not likely result in the development of resistance or have a negative impact on the safety or wellbeing of the environment, animals or people.

The current situation

Agricultural chemical products

With conditions as outlined in the legislative instrument, the agricultural chemical products that currently may satisfy the efficacy criteria based on type of product include:

• domestic or home garden products
• adjuvants, wetters and surfactants
• drift retardants
• plant growth regulators
• semiochemical-based mating disruptors and semiochemical lures
• defoliants
• spray-marker dyes
• mosquito coils and candles.

Veterinary chemical products

With conditions as outlined in the legislative instrument, the veterinary chemical products that currently may satisfy the efficacy criteria based on type of product include:

• counterirritants, rubifacients and poultices
• enzymes, direct-fed microbials and probiotics
• pet foods containing enzymes or direct fed microbials
• autogenous vaccines (as the subject of a permit that comply with the appropriate APVMA guidelines)
• sheep branding substances.

Consultation

The APVMA invites comment on the current legislative instrument and suggestions for including further types of agricultural and veterinary chemical products where satisfaction of the efficacy criteria may be based on product type alone.

Suggestions for inclusion of further products must be accompanied by scientific argument as to the suitability of the proposed product type/s.

The scientific argument must include information to establish that suboptimal efficacy or inefficacy would not likely result in the development of resistance or have a negative impact on the safety or wellbeing of the environment, animals or people.

Submissions will be considered by the APVMA, State and Territory Departments, the Office of Chemical Safety and the Department of the Environment before any decisions regarding proposals are made.

Please send your written submission by email, post or fax to:

Efficacy Assessment Coordinator
Australian Pesticides and Veterinary Medicines Authority PO Box 6182
KINGSTON ACT 2604

Fax + 61 2 6210 4776

Email: enquiries@apvma.gov.au

For enquiries, please call +61 2 6210 4778.