Gazette APVMA 11, 2 November 2004

NOTICE

Bacillus sphaericus Strain 2362

[in the product: VECTOLEX WG BIOLOGICAL LARVICIDE]

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Valent BioSciences, a Division of Sumitomo Chemical Australia Pty Ltd, for registration of a new product containing the active constituent Bacillus sphaericus Strain 2362. The product is VECTOLEX WG BIOLOGICAL LARVICIDE is for the control of Culex spp. and Anopheles spp. mosquitoes in stagnant and standing ponds, flood and irrigation water, ditches, storm water retention areas, tidal water and salt marshes, water with moderate to high organic content and sewerage settling ponds.

In accordance with sections 12 and 13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the application for registration should be granted. Submissions should state the grounds on which they are based. Such grounds should relate only to matters outlined below that the APVMA is required to take into account in deciding whether to grant the application. Comments must be received by the APVMA within 28 days of the date of this notice.

Particulars of Application

Product Name: VECTOLEX WG BIOLOGICAL LARVICIDE
Applicant Company: Valent BioSciences, a Division of Sumitomo Chemical Australia Pty Ltd
Active Constituent: Bacillus sphaericus Strain 2362
Poisons Scheduling: Exempt
Statement of Claims: For the control of the mosquito species Culex spp. and Anopheles spp. in stagnant and standing ponds, flood and irrigation water, ditches, storm water retention areas, tidal water and salt marshes, water with moderate to high organic content and sewerage settling ponds.
Pack sizes: 500g, 10kg, 25kg
Withholding period: Not applicable

Summary of the APVMA’s evaluation of VECTOLEX WG BIOLOGICAL LARVICIDE in accordance with Section 14(3)(e) and (f) of the Agricultural and Veterinary Chemicals Code (the ‘Agvet Code’), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994

The APVMA has evaluated the application and in its assessment in relation to human and environmental safety under section 14(3)(e) of the Agvet Code, it proposes to determine that:

(i) The APVMA is satisfied that the proposed use of VECTOLEX WG BIOLOGICAL LARVICIDE would not be an undue hazard to the safety of people exposed to it during its handling and use.

The National Occupational Health and Safety Commission (NOHSC) has conducted a risk assessment on VECTOLEX WG BIOLOGICAL LARVICIDE and concluded that it can be used safely when used according to the proposed label directions.

Bacillus sphaericus Strain 2362 is manufactured overseas and the formulated VECTOLEX WG BIOLOGICAL LARVICIDE will be imported into Australia in ready to sell containers. Repacking will not be required in Australia. On the basis of its low toxicity, Bacillus sphaericus Strain 2362 and VECTOLEX WG BIOLOGICAL LARVICIDE are determined to be exempt from the requirement of poisons scheduling. Appropriate personal protective equipment has been set for workers preparing and applying the prepared spray.

The APVMA has considered and accepts the findings and recommendations of the NOHSC assessment on this criterion.

(ii) The Chemistry and Residue Program of the APVMA having assessed the residue aspects of VECTOLEX WG BIOLOGICAL LARVICIDE is satisfied that the proposed use of this product will not be an undue hazard to the safety of people using anything containing its residues when used according to label directions. An appropriate MRL has been established in Table 5 of the MRL Standard. The product VECTOLEX WG BIOLOGICAL LARVICIDE do not require a withholding period when used according to label directions.

(iii) The APVMA is satisfied that the proposed use of VECTOLEX WG BIOLOGICAL LARVICIDE is not likely to be harmful to human beings if used according to the product label directions.

The active constituent, Bacillus sphaericus Strain 2362, has been evaluated and approved by the APVMA.

The National Drugs and Poisons Schedule Committee has considered Bacillus sphaericus Strain 2362 and determined that it is exempt from the requirement of poisons scheduling. An appropriate signal heading is included on the product label. Safety directions for Bacillus sphaericus Strain 2362 have been recommended by the Commonwealth Department of Health and Ageing and NOHSC and have been included on the product label. Appropriate first aid instructions have also been recommended.

The APVMa has considered and accepts the findings and recommendations of its advisers with regard to matters concerning public health.

(iv) The APVMA is satisfied that the proposed use of VECTOLEX WG BIOLOGICAL LARVICIDE in the situations stated on the label is not likely to have an unintended effect that is harmful to animals, plants or the environment.

The Department of the Environment and Heritage (DEH) has assessed data in support of the proposed use of VECTOLEX WG BIOLOGICAL LARVICIDE .

Bacillus sphaericus is found in soil and aquatic environments around the world. Both insecticidal and non-insecticidal strains are known.

Bacillus sphaericus is able to control mosquito populations with little or no effect on non-target insects and other invertebrates inhabiting the same environment. Bacillus sphaericus is highly specific for all Culex spp. and many Anopheles spp. of mosquitoes. Many toxicity studies have demonstrated that birds, fish, microcrustaceans and marine/freshwater/estuarine invertebrates that cohabit with the target mosquito larvae are not adversely affected by Bacillus sphaericus at concentrations that are expected to be present in the environment as a result of using VECTOLEX WG BIOLOGICAL LARVICIDE according to label directions.

VECTOLEX WG BIOLOGICAL LARVICIDE will be formulated overseas and imported into Australia in sealed containers. Once in Australia environmental exposure is possible, particularly during transport, sale, mixing and application. Inadvertent release of VECTOLEX WG BIOLOGICAL LARVICIDE into the environment though improper disposal or accidental release is not likely, as the product label contains adequate instructions for mixing, application and storage and disposal.

The APVMA has considered the findings of DEH and accepts its recommendations on this criterion.

(v) The APVMA is satisfied that the proposed use of VECTOLEX WG BIOLOGICAL LARVICIDE would not adversely affect trade between Australia and places outside Australia.

In relation to its assessment of efficacy under section 14(3)(f), the APVMA proposes to determine that:

(i) The APVMA is satisfied the data from trials supporting the efficacy of VECTOLEX WG BIOLOGICAL LARVICIDE adequately demonstrates that under local conditions this product is effective for the proposed uses.

Public Release Summary

A Public Release Summary of the evaluation is available by contacting David Hutchison on telephone (02) 6271 6384. Written submissions on the APVMA’s proposal to grant the application for registration should be received at the APVMA by 7 December 2004, and addressed to:

Jenny Dunn
Pesticides Division
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604

Phone: (02) 6272 5890
Fax: (02) 6272 3218




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