Gazette APVMA 12, 2 December 2003 - Page 22



[in the product: PROCLAIM INSECTICIDE]

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Syngenta Crop Protection Pty. Ltd. to vary the registration of PROCLAIM INSECTICIDE to include use on capsicum, lettuce and tomato crops for the control of Heliothis (Helicoverpa armigera, Helicoverpa punctigera).

This involves approving a new product label for this product. The application also requires the establishment of Maximum Residue Limits (MRLs) and corresponding Withholding Periods (WHPs) for the product when used on capsicum, lettuce and tomato crops.

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: Syngenta Crop Protection Pty. Ltd.
Name of active constituent: Emamectin (44 g/kg)
Signal Heading: Schedule 6
Statement of claims: For the control of Heliothis (Helicoverpa armigera,
helicoverpa punctigera) in capsicum, lettuce and
Pack sizes: 550g, 1kg, & 1.1kg
Proposed emamectin MRLs:

Table 1 mg/kg
Lettuce, head 0.2
Lettuce, leafy 0.2
Peppers, sweet [Capsicums] 0.01
Tomato 0.01

Withholding Periods:

Do not harvest for 3 days after application
Do not allow livestock to graze treated crops

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:

The APVMA is satisfied that the use of this product would not present an undue hazard to the safety of people consuming capsicums, lettuce or tomatoes that are treated with this product.

Trade Evaluation

The Chemistry and Residues Program of the APVMA has completed an evaluation of the data and has supported the proposed MRLs and Withholding Periods for this product and use patterns.

There are currently no CODEX MRLs for emamectin. MRL tolerances for residues of emamectin have been set in some importing countries as follows:

Country Commodity MRL, mg/kg
Japan Lettuce 0.1
Taiwan Leafy vegetable group 0.05
USA Lettuce (head) 0.025

Export of treated produce containing detectable residues of emamectin 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.

Capsicum, lettuce and tomato
Residue data submitted with the application indicate that detectable residues of emamectin may occur in capsicum, lettuce and tomato after the harvest withholding period of 3 days.

The quantities of capsicum, lettuce and tomato exported from Australia account for 2%, 2% and 1% of domestic production respectively. The major market for both capsicums and tomatoes is New Zealand. Residues of emamectin should be acceptable in this market through MRLs established in the Australia New Zealand Food Standards Code.

While some export markets do not have MRLs or import tolerances established the relative volumes of capsicum, lettuce and tomato exported are considered unlikely to result in undue prejudice to Australia's export trade.

The following statement has been recommended for inclusion on the product label:
EXPORT TRADE ADVICE -"Export of treated produce: MRLS or import tolerances for Emamectin may not be established in all markets. If you are using this product on capsicum, lettuce or tomatoes for export, please check with Syngenta Crop Protection Pty. Ltd. before using this product."

Animal commodities
Capsicums, lettuce and tomatoes are not considered to be major livestock feed sources, although waste vegetables could be fed sporadically.

MRLs for emamectin in commodities of animal origin have previously been established based on a maximum feeding level of 0.026 ppm in the diet. Residues in livestock fed waste vegetables at up to 5% of the diet should comply with current MRLs.

Livestock grazing failed crops as the sole food source could be exposed to higher levels of emamectin. A grazing restraint has been recommended for treated crops.

The APVMA welcomes comment on whether or not the proposed use of emamectin on capsicum, lettuce and tomatoes, poses an undue prejudice to Australia's trade in these commodities.

A Trade Advice Notice (TAN) has been circulated to peak bodies of industry to allow comment prior to the determination of the application. Copies of the TAN are available on request.

Other Criteria

Additionally, the following criteria are being addressed by the APVMA during the evaluation of this application:

Chemistry and Manufacture
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:

Rod Edmundson
Agricultural & Veterinary Chemicals Evaluation
National Registration Authority for Agricultural and Veterinary Chemicals
PO Box E240

Phone: (02) 627 3859
Fax: (02) 627 3218

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