Table of Contents
The World Association for the Advancement of Veterinary Parasitology (WAAVP) is a not-for-profit organisation for scientists who study the parasites of non-human animals. The guidelines, developed by the international expert working groups of the WAAVP, assist in the international harmonisation of standards and procedures for the evaluation of veterinary parasiticides. The WAAVP guidelines for evaluating the efficacy of ectoparasiticides on ruminants aim to standardise the minimum set of data that should be submitted to demonstrate the efficacy of new ectoparasiticides for use on or in ruminants.
The APVMA has adopted the WAAVP guidelines for evaluating the efficacy of ectoparasiticides on ruminants to assist registration holders in the conduct of regulatory trials. The APVMA notes that in some instances the WAAVP guidelines advise consultation with the regulator. We also recognise that because of Australia’s unique environmental and geographic parameters, parasite burdens and their population dynamics, farm management practices and animal breeds, there are some differences between the WAAVP guidelines and the APVMA’s recommendations for efficacy trials for products to be registered in Australia. Therefore, applicants should conduct efficacy trials within Australia under typical farm management practices covering relevant geographical regions and the following additional guidance is provided to assist you in conducting these trials. If you follow this additional guidance, your data should generally be sufficient for the APVMA to assess its confidence in the product’s efficacy given Australia’s unique conditions.
This preamble refers to the following World Association for the Advancement of Veterinary Parasitology (WAAVP) guideline: Holdsworth, PA, Vercruysse, J, Rehbein, S, Peter, R, De Bruin, C, Letonja, T & Green, P 2006, ‘World Association for the Advancement of Veterinary Parasitology (WAAVP) guidelines for evaluating the efficacy of ectoparasiticides against biting and nuisance flies on ruminants’, Veterinary Parasitology, vol. 136, pp. 3–13.
1. Field trials for buffalo fly
The WAAVP guidelines recommend that you carry out studies in several locations; and that you select a minimum of two studies in each geographic location.
As additional guidance, the APVMA recommends a minimum of four trial sites to be selected from Table 1, which sets out the number, location and timing of field trials for buffalo fly. At least two of these trial sites should be situated in Tropical Queensland, and one in Central Queensland. The fourth site can be located in the South East, or in one of the other areas mentioned. Where the intention is to register the product for use on dairy cattle, a fifth site, located on a dairy farm in one of the regions listed, should also be chosen for an efficacy trial.
|Region||Number of trials||Area||Timing of trials|
|Tropical Queensland||2||High-rainfall area north of Townsville||November to April|
|Central Queensland||1||Bundaberg north to Mackay||December to April|
|South East Queensland||1||Buffalo-fly-infested area south of Bundaberg||January to April|
The World Association for the Advancement of Veterinary Parasitology guidelines address rainfastness generally: ‘Where artificial rainfall is used in dose confirmatory studies to test the efficacy of a topically applied test product after heavy rain, the method of wetting used and the equivalent in terms of natural rainfall should be stated (eg artificial rain applied by sprinklers, equivalent to a rainfall of 20 millimetres in a storm lasting 30 minutes). The time of animal wetting before or after test product application should be recorded (eg 0, 2 hours, etc.)’.
For trials conducted for buffalo fly, the APVMA suggests as a guide that animals be subjected to the equivalent of 12.5 millimetres of rainfall over a 10-minute period.
3. Wool or hide damage
Given the importance of the wool and cattle by-product industries to Australian commerce, it is recommended that you collect and submit data on wool staining or damage, hide or skin damage, or damage to animal products.