Gazette APVMA 8, 2 August 2005 page 26

NOTICE

Tetraconazole

in the product: DOMARK 40ME FUNGICIDE

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Sipcam Pacific Australia Pty Ltd for registration of a new product containing the active constituent tetraconazole. This is the first time that a product is to be registered with this active constituent. The product is DOMARK 40ME FUNGICIDE which is proposed for use on grapevines to control powdery mildew.

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

Proposed product name: DOMARK 40ME FUNGICIDE
Applicant company: Sipcam Pacific Australia Pty Ltd
Name of active constituent: Tetraconazole
Signal heading: Schedule 5
Statement of claims: For the control of powdery mildew on
grapevines
Pack sizes: 1 L; 5 L
Withholding period: Grapes: Do not harvest table, dried, or wine
for domestic consumption for 14 days after
application Summary of the APVMA’s evaluation of DOMARK 40ME FUNGICIDE 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 DOMARK 40 ME FUNGICIDE would not be an undue hazard to the safety of people exposed to it during its handling and use.

The Office of Chemical Safety (OCS) has conducted a risk assessment on DOMARK 40ME FUNGICIDE and concluded that it can be used safely. Domark 40ME Fungicide has low acute oral, dermal and inhalation toxicity in rats. The product is not a skin or eye irritant in rabbits, and is not a skin sensitiser in guinea pigs. The main hazards associated with repeat exposure to the product are systemic effects on the liver and changes in haematology parameters.

The APVMA has considered the findings of the OCS report and accepts its recommendations.

(ii) The APVMA is satisfied that the proposed use of DOMARK 40ME FUNGICIDE will not be an undue hazard to the safety of people using anything containing its residues. Residue data was assessed by the APVMA and Maximum Residue Limits (MRLs) and Withholding Periods (WHPs) were set for tetraconazole when used on grapevines.

(iii) The APVMA is satisfied that the proposed use of DOMARK 40ME FUNGICIDE is not likely to be harmful to human beings if used according to the product label directions.

The active constituent has been evaluated and approved by the APVMA. The product is scheduled as Schedule 5 of the SUSDP. The appropriate Signal Heading is on the label. First Aid and Safety Directions for tetraconazole have been recommended by the Commonwealth Department of Health and Ageing and have been included on the label.

The APVMA has considered the findings of its advisers on this criteria and accepts their recommendations.

(iv) The APVMA is satisfied that the proposed use of DOMARK 40ME FUNGICIDE on powdery mildew on grapevines is not likely to have an unintended effect that is harmful to animals, plants or the environment.

The Department of the Environment and Heritage has assessed data in support of the proposed use and has concluded that the risks to the environment from the proposed use are acceptable.

Tetraconazole is not susceptible to hydrolysis or photolysis under environmental conditions. Soil metabolism and field dissipation studies show a considerable slowing in the degradation rate over time. It is likely to be persistent in soils though of low mobility in a range of soils where leaching is unlikely to occur. It is expected to be persist in water/sediment systems but is not considered bioaccumulative.

Tetraconazole is moderately toxic to birds, fish and sediment dwelling organisms but is highly toxic to aquatic invertebrates, alga and aquatic plants. Toxicity testings on metabolites indicate these are less toxic than the parent compound. However, there is some toxicity to honey bees, earthworms and some terrestrial arthropods. Nitrogen transformation and carbon mineralisation were not affected in soil microbial testing at much higher rates than proposed. Toxicity tests on plants indicate that tetraconazole has no toxic effect at the proposed application rate.

The environmental risk to birds and aquatic organisms from the proposed use of tetraconazole is considered acceptable. Run-off and spray drift from ground spraying are unlikely to pose an aquatic risk. No adverse effects on non-target vegetation at the proposed low application rate is expected.

The APVMA has considered the findings of the Department of the Environment and Heritage and accepts its recommendations on this criterion.

(iv) The relevant commodities in the current application are exported and detectable residues could occur above the standards of key export markets Use of the product could potentially affect trade or commerce between Australia and other places. .

Label statements to the effect that, where grapes are intended for export, the grower is advised to consult the winemaker, industry spray diary or peak industry body to determine the recommended withholding period, are proposed for inclusion on the label to manage this risk.

The relevant industry groups are requested to comment on the perceived level of risk and whether the proposed statements or any other industry-initiated strategies are required to manage the risk.
.
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 DOMARK 40ME FUNGICIDE adequately demonstrates that under local conditions this product is effective for the proposed uses.

Public Release Summary

A Public Release Summary of the evaluation will be available from 2 August 2005 on the APVMA website www.apvma.gov.au or by contacting David Hutchison on telephone (02) 6271 6384. Written submissions on the APVMA’s proposal to grant the application for registration should be addressed to:

Dr G.F.Smart
Pesticides Program
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604

Phone: (02) 6272 3354
Fax: (02) 6272 3218
Email: geoffrey.smart@apvma.gov.au