ADVICE SUMMARY APPLICATION FOR VARIATION OF A REGISTERED CHEMICAL PRODUCT

Product name: Applicant: Product number: Application number: AGITA 100 PLUS FLY SPRAY AND PAINT-ON NOVARTIS ANIMAL HEALTH AUSTRALASIA PTY LIMITED 55288 41446

Purpose of Application and Description of Use: Variation of the label approval to add an additonal method of application (spray on) and extend the use of product to include commercial, industrial and domestic areas. Active Constituent(s): (Z)-9-TRICOSENE THIAMETHOXAM

Regulatory Decision: To grant the application subject to the following conditions: Standard Conditions of Label Approval 1. Label must contain an Expiry Date and Batch Number For full conditions, refer to http://www.apvma.gov.au/advice_summaries/adv_summaries.shtml.

ADVICE

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State/External Efficacy Reviewer

Data were submitted from 2 laboratory studies and one field study to demonstrate the efficacy when used as a spot-spray application against houseflies in laboratory and commercial field use situations. The first laboratory study of direct spray knock-down assay compared the knockdown times for mixed sex adult Musca domestica of 3 application rates (high, commercial and low) of Agita 100 Plus Fly Spray and Paint-on against two registered fly control products. Knockdown was assessed every 15-60 seconds for a maximum of 960 seconds. Mortality was assessed after 24 h. KD50 was reached in 5 min and KD90 within 12 min for all treatments. There were no significant differences between mortality at 24 h for the 5 treatments. This trial while not reflecting the use pattern nonetheless confirmed the efficacy of Agita 100 Plus Fly Spray and Paint-on when used as a spot spray. The second laboratory assay consisted of the same five treatments as above but was done on various porous and non-porous surfaces. Plywood, painted plywood, stainless steel and concrete plates (200 x 200 mm) were sprayed at three rates of Agita 100 Plus Fly Paint-on and recommended rates of two commercial fly control products. Knockdown of M. domestica was recorded after 15, 30, 60, 120 and 180 min and mortality 24 h after initial exposure. Assays were run 24 h and 1, 2, 3 and 4 weeks after treatment of the plates. The results showed that Agita 100 Plus Fly Spray and Paint-on at the two higher dose rates was the more consistent in producing high mortality over the range of surfaces tested and for the different storage times. Data presented confirmed the residual efficacy (indoor situations) of Agita 100 Plus Fly Spray and Paint-on against M. domestica on a range of porous and non-porous surfaces. The field trial compared two registerd bait formulations and Agita 100 Plus Fly Spray and Paint-on at a commercial piggery in NSW. Groups of 5-6 plywood plates (20 x 30 cm) treated with the three products were individually placed on paper sheets (0.6 x 0.8 m) in each of 9 units (6 pig raising and 3 ration preparing areas). Dead flies were counted and removed at 60, 90, 120, 180, 240 and 300 min and 24 h post-exposure. Results of the mean number of dead houseflies on the plywood plates sprayed individually with the three products were presented against each sampling time up to 24 h. The cumulative mean of dead flies recorded for Agita 100 Plus Fly Spray and Paint-on was 1070.4. This field trial also confirmed the efficacy of Agita 100 Plus Fly Spray and Paint-on against M. domestica with a spray-on use pattern in a commercial situation. Trial design, data analysis and validation were generally adequate. Statistical analyses were provided for the laboratory trials. Data from all three trials outlined above confirmed the efficacy of the product against M. domestica when used as a spot-spray application. The applicant provided adequate argument to justify the extension of Agita 100 Plus Fly Spray and Paint-on to commercial, industrial and domestic use situations. The directions for use and other label instructions are compatible with label claims. The label extension to include control of houseflies when used as a spot-spray application in commercial, industrial and domestic use situations is supported.

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Data relied on to provide the advice

Data No Data Source* Author(s) Title Date Data Type Data Sub-type Authorising Party Inherited Application No.

11255

Anon, Insect Research laboratory, Australia Miller and Peters, Insect Research laboratory, Australia Anon, Insect Research laboratory, Australia

11256

11257

Laboratory Study to determine the direct spray knockdown of various wet spray formulations against Musca domestica Laboratory Study to determine the residual efficacy of various wet spray formulations against Musca domestica Comparative Field trial to assess the efficacy of agita WG10 and two competitor products against Musca domestica in a piggery

May 2006 May 2006 May 2006

Efficacy and Safety

Efficacy

Applicant

Efficacy and Safety

Efficacy

Applicant

Efficacy and Safety

Efficacy

Applicant

* S = Data submitted with the application

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