This consultation closed on 29 October 2024
The APVMA is considering an application for the registration of the product Zorvec Encantia Fungicide, containing 300 g/L famoxadone and 30 g/L oxathiapiprolin, as a suspension concentrate (SC) formulation. The product is intended for the control of downy mildew caused by Peronospora spp. in spinach and rocket.
Submissions received
The APVMA sought comment from interested stakeholders on the evaluation of the new active famoxadone in the product Zorvec Encantia Fungicide in a consultation that closed on 29 October 2024.
One submission was received.
Consultation feedback
One submission was received stating that ‘famoxadone is no longer approved for use in Great Britain, due to the unacceptable environmental risk it poses, especially to bird life’, and requesting that its registration therefore be denied in Australia.
The APVMA is aware that registration of famoxadone in the United Kingdom (UK) was proposed to be withdrawn by the UK Health and Safety Executive (HSE) in January 2024. The grounds provided for the proposed action were that ‘HSE has been unable to demonstrate that there will be no unacceptable impact on birds’. The rationale underlying the proposed HSE action relates to re-evaluation of previous statistical analyses of tests for reproductive toxicity of famoxadone in mallard ducks and bobwhite quail.
The same avian studies have also been reanalysed by the Environmental Fate and Effects Division of the US Environmental Protection Agency (US EPA) using current statistical methods, with the conclusion that adjusted toxicological endpoints can be validly derived and applied.
APVMA response to submission
The APVMA has reevaluated these studies and in response has adopted the adjusted toxicological endpoints accepted by the US EPA. This revision has led to additional risk assessment by the APVMA of the predicted consequences of use of famoxadone for birds, which have been found to meet appropriate levels of environmental safety.