Advice Summary Product No Application No by mikesanye

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									                                                                        ADVICE SUMMARY
                             APPLICATION FOR VARIATION OF A REGISTERED CHEMICAL PRODUCT

Product name:               VECTOBAC WG BIOLOGICAL LARVICIDE WATER DISPERSIBLE GRANULE
Applicant:                  VALENT BIOSCIENCES A DIV OF SUMITOMO CHEMICAL AUSTRALIA
Product number:             52642
Application number:         48296

Purpose of Application and Description of Use:           Variation of registration and label approval to change product name from Vectobac WG Biological larvicide to Vectobac® WG
                         Biological Larvicide Water Dispersible Granule and to extend the use to include the control of Dengue vectors including Aedes aegypti and Aedes albopictus

Active Constituent(s):      BACILLUS THURINGIENSIS SUBSP. ISRAELENSIS


Regulatory Decision:
To grant the application subject to the following conditions:

Standard Conditions of Label Approval
    1. Label must contain a Date of Manufacture, Batch Number and Expiry Date no greater than X years after the DOM (Ag only)
For full conditions, refer to http://www.apvma.gov.au/advice_summaries/adv_summaries.shtml.

Non-Standard Conditions of Approval




ADVICE


48296                                                                              Page 1 of 3                                                     KP25S_F40 Version: 2 Issued: 10/08/2007
State/External Efficacy Reviewer
   The applicant provided two peer reviewed scientific publications and data from three unpublished field trials to demonstrate that the active of the proposed
   product, Bti, is efficacious in controlling Aedes mosquito larvae. The published scientific publications were laboratory trials that established the LD50 and
   LD95 of Bti formulations against the target species, Aedes aegypti, (as well as other mosquitoes) and the effect of the proposed label rates. The field trials
   were designed to demonstrate that the product when applied as a granule will provide control of the target species, have a residual effect and can also be
   applied by misting.

   The published laboratory investigations were designed to demonstrate the effectiveness of the active and product. The latter three trials were undertaken in
   the field environment where normal control operations against Aedes aegypti would be undertaken using dose rates as per label instructions. Thus the field
   trials are directly relevant to normal use patterns. All trials were conducted and analysed appropriately.

The trial data provided demonstrates that VectoBac WG is efficacious against the larvae of Aedes aegypti and ipso facto, Aedes albopictus. It can also be concluded that ground application
spray equipment can be used, a higher dose rate can provide longer term control, and the treatment of dry containers before flooding for up to two months can achieve control. Thus the label
claims of efficacy are substantiated.

Data relied on to provide the advice
                                                                                                                                                                                             Inherited
Data      Data             Author(s)                                 Title                               Date         Data Type               Data Sub-type              Authorising        Application
No        Source*                                                                                                                                                          Party                No.
33385     S         Dr Scott A Ritchie, Dr    Mist spray application of VectoBac WDG for               Aug      Efficacy and Safety      Efficacy                     Applicant
                    Luke P Rapley, Dr         residual control of hidden container-breeding            2008
                    Petrina J Johnson,        mosquito habitats in a northern Australian
                    Michelle Larkman          bushland setting
                    and Rebecca Silcock
33381     S         Brown, MD,, Carter,       Evaluation of Liquid Bacillus thuringiensis var          2001     Efficacy and Safety      Efficacy                     Public
                    J., Watson, T.M.,         israelensis Products for Control of Australia
                    Thomas, P.,               Aedes aegypti Arbovirus Vectors
                    Santaguliana, G.,
                    Purdie, DM and Kay,
                    BH
33383     S         Scott A. Ritchie and      Residual Treatment of Aedes aegypti in                   2007     Efficacy and Safety      Efficacy                     Applicant
                    Luke Rapley               Containers using VectoBac WG
33384     S         Scott A Ritchie and       Pre-treatment of dry containers using VectoBac           2008     Efficacy and Safety      Efficacy                     Applicant
                    Luke P Rapley             WG for residual control of the dengue fever




48296                                                                                    Page 2 of 3                                                          KP25S_F40 Version: 2 Issued: 10/08/2007
                                                                                                                                                                                   Inherited
Data    Data            Author(s)                             Title                                Date         Data Type           Data Sub-type              Authorising        Application
No      Source*                                                                                                                                                  Party                No.
                                        mosquito, Aedes aegypti
33382   S         Russel, TL., Brown,   Efficacy of VectoBac (Bacillus thuringiensis             2003     Efficacy and Safety   Efficacy                    Public
                  MD., Purdie, DM.,     variety israelensis) Formulations for Mosquito
                  Ryan, PA and Kay,     Control in Australia
                  BH




Other Details About The APVMA’s Decision To Grant The Application
The applicant provide document that demonstrated that Vectobac fullfilled the World Health Organisations (WHO) Pesticide Evalaution Scheme (WHOPES)
requirements by meeting the WHO Specfiication and Evaluations for Public Health Pesticides Baccillus thuringiensis (Bti) subspecies israelensis, strain
AM65-52 water dispersible granule. A WHO review of Baccillus thuringiensis subspecies israelensis, strain AM65-52, states” Bti is not considere to pose a
hazard to humans through drinking water. There fore it is not considered necessary or appropriate to establish a guideline for its use for controlling vector
larvae in drinking water”.


Data relied on
                                                                                                                                                                                   Inherited
Data    Data            Author(s)                             Title                                Date         Data Type           Data Sub-type              Authorising        Application
No      Source*                                                                                                                                                  Party                No.
48431   S         Dr Lorenzo Savioli    Letter from Dr Lorenzo Savioli, WHO                      11 Dec   Toxicology            Other Information           Applicant
                                                                                                 2007
48432   S         WHO                   WHO Specifications and Evaluations for Public            June     Toxicology            Other Information           Public
                                        Health Pesticides - Bacillus thuringiensis               2007
                                        subspecies israelensis strain AM65-52
48650   S         WHO                   WHO 4th Edition Bti Summary statement April              2009     Toxicology            Other Information           Public
                                        2010

* S = Data submitted with the application
  I = Data inherited (that is, referenced) from another application




48296                                                                              Page 3 of 3                                                      KP25S_F40 Version: 2 Issued: 10/08/2007

								
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