Table of contents
This preamble refers to the following World Association for the Advancement of Veterinary Parasitology (WAAVP) guideline:
Marchiondo, A.A., Holdsworth, P.A., Fourie L.J., Rugg D., Hellmann K., Snyder D.E. Dryden M.W. 2013, ‘World Association for the Advancement of Veterinary Parasitology (WAAVP) second edition: Guidelines for evaluating the efficacy of parasiticides for the treatment, prevention and control of flea and tick infestation on dogs and cats’, Vet Parasitology, vol. 194, pp. 84-97.
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.
We have adopted this WAAVP guideline, which is to be used in conjunction with the Australian Pesticides and Veterinary Medicines Authority's (APVMA) Efficacy and safety guidelines (Part 8).
Because of Australia’s unique environmental and geographic features, parasites and parasite burdens and their population dynamics, there are some differences between the WAAVP recommendations and our recommendations for products that are to be registered in Australia. In the sections below, we have provided additional guidance to assist applicants in conducting trials for the registration of such products in Australia.
1. Fleas
For fleas, the efficacy standard is set at 95%. The claim is for the ‘control’ of fleas.
Efficacy based on both geometric and arithmetic means will be taken into consideration when assessing a claim (see Note on geometric versus arithmetic means below).
1.1. Pen and field studies
You should conduct pen and clinical field studies as described in the WAAVP guidelines. Studies should be conducted for at least the claimed period of control.
You should conduct at least 2 Australian clinical field studies for each animal species:
- One field study conducted in a humid tropical or sub-tropical region with summer-dominant rainfall
- One field study in a humid subtropical environment with rainfall more evenly distributed throughout the year
Animals used in the clinical field studies should have at least a moderate score for flea infestation (6 to 20 fleas per animal using the comb-counting technique).
In the clinical field studies, fleas removed from an animal during comb counting should be placed back onto the animal after counting has been completed.
To determine efficacy in the clinical field studies, you should compare the post-treatment flea counts to the pre-treatment flea counts. If a positive control is included, you can, in addition, compare the efficacy of the control treatment with the test treatment.
1.2. Flea allergy dermatitis
We will not accept a claim for ‘treats or reduces the incidence of flea allergy dermatitis’ without receiving supporting data that clearly demonstrate a reduction in the clinical signs of flea allergy dermatitis. If you do not provide data that specifically demonstrate a reduction in the clinical signs of flea allergy dermatitis but can demonstrate a 95% short-term persistent (4 to 6 weeks) flea efficacy, we may accept a label claim of ‘controls flea allergy dermatitis’.
2. Ticks
We will not accept a general claim for tick control. Instead, you should provide data for each species of tick for which a claim is sought.
Efficacy based on both geometric and arithmetic means will be taken into consideration when we assess a claim (see Note on geometric versus arithmetic means below).
2.1. Rhipicephalus sanguineus
For Rhipicephalus sanguineus, the efficacy standard for a ‘control’ claim is set at 95%. You should conduct the efficacy trials as described in the WAAVP guidelines; however, at least one of the studies should be conducted with Australian strains of Rhipicephalus sanguineus (either an Australian dose-confirmation study or preferably an Australian clinical field study).
2.2. Ixodes holocyclus
For Ixodes holocyclus, the efficacy standard for a ‘control’ claim is set at 95% within 3 days (72 hours). Because of the profound clinical significance of this tick, product labels should advise users to check animals daily for ticks.
You should conduct 2 dose-confirmation studies for each animal species. The studies should include groups of animals infested with ticks collected from regions representative of the entire geographic range of Ixodes holocyclus.
You should take care during the tick infestation and counting periods to prevent transfer of ticks between groups of animals e.g. you could consider isolating animals. After applying the acaricide, manually count and record the viability and attachment status of ticks 24, 48 and 72 hours after treatment, then remove any remaining ticks. Rechallenge and repeat this procedure at intervals up to the claimed period for control. Do not use sedation for assessments.
3. Vector-borne diseases
The APVMA will not accept consequential claims for transmission of flea and tick-borne diseases based only on efficacy against the host parasite. If you are seeking to make such claims, you should provide data that demonstrate efficacy against the vector-borne diseases.
4. Shampooing and wetting
For products applied topically, you should conduct studies that demonstrate efficacy following shampooing and wetting. If you do not provide these studies, you should include a warning on the label that efficacy after shampooing and wetting has not been assessed.
5. Note on geometric versus arithmetic means
The geometric mean is appropriate for statistical tests where data is non-normally distributed. However, the geometric mean may underestimate the biological significance of parasites on animals with the highest infestation. We consider that the current information on statistics does not support the adoption of geometric means as the sole means of interpreting trial data. Therefore, we will consider efficacy based on both geometric and arithmetic means when assessing claims for fleas and ticks.