Gazette APVMA 3, 2 March 2004 - Page12



[in the product: SCORE FOLIAR FUNGICIDE]

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Syngenta Crop Protection Pty Limited to vary the registration of SCORE FOLIAR FUNGICIDE to include control of husk spot in macadamias. This involves approving a new product label and the establishment of a Maximum Residue Limit (MRL) for difenoconazole in macadamias. The product is currently registered for use on potatoes, tomatoes, carrots and bananas.

The APVMA invites any person to submit a relevant written submission as to whether the application to vary the registration to extend the use of this product to include these new uses should be granted. Such submissions should detail comments stating the grounds on which the submission is based. Such grounds should relate only to the trade implications of the extended use of the product. Comments must be received by the APVMA within 28 days of the date of this notice.

Particulars of Application

Applicant Company: Syngenta Crop Protection Pty Limited
Active Constituent: difenoconazole
Signal Heading: Schedule 5
Statement of Additional claims: For the control of husk spot in macadamias.
Pack Sizes: 5, 10 & 50 L.
Proposed difenoconazole MRL: Table 1
Food MRL (mg/kg)
Macadamia nuts *0.01 *Denotes MRL set at the analytical limit of quantitation (LOQ)
Withholding Period:
Not required when used as directed.

Summary of the APVMA's assessment of the application in accordance with sections 29(1)(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 29(1)(e) of the Agvet Code, it proposes to determine that:

Residues Evaluation

The APVMA is satisfied that the proposed use of this product would not present an undue hazard to the safety of people consuming the produce of crops treated with this chemical.

The Chemistry and Residues Program of the APVMA has completed an evaluation of the data and has supported the proposed MRL.

Trade Evaluation

Export of treated produce containing finite (measurable) residues of difenoconazole may pose a risk to Australian trade in situations where (i) no residue tolerance (import tolerance) is established in the importing country or (ii) where residues in Australian produce are likely to exceed a residue tolerance (import tolerance) established in the importing country.

Residue data indicated that detectable residues of difenoconazole are unlikely to occur in treated macadamias when the product is used according to label directions. Detection of difenoconazole residues in macadamia nuts by importing countries is therefore unlikely to occur. It is concluded that establishment of the difenoconazole MRL as described above woud not create direct trade issues as residues are expected to be below the Limit of Quantitation (LOQ).

The APVMA welcomes comment with regard to whether the proposed use of difenoconazole on macadamias poses an undue prejudice to Australia's trade in this commodity.

A Trade Advice Notice (TAN) which includes a more detailed summary of the assessment will be circulated to peak bodies of industry groups to allow comment prior to the determination of the application. Copies of the TAN are available on request.

Other Criteria

Additionally, the APVMA has addressed the following criteria during the evaluation of a previous application:

Occupational Health and Safety
Environmental Safety
Target Species Efficacy and Safety


Comments relating to the trade implications of the proposal to grant this application for variation of registration should be addressed in writing to:

Pat Robinson
Pesticides Program
Australian Pesticides and Veterinary Medicines Authority
PO Box E240

Phone: (02) 6271 6320
Fax: (02) 6272 3218

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