Gazette APVMA 8, 3 August 2004 - Page 22



[in the product: DIPTEREX 500 SL INSECTICIDE]

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Bayer CropScience Pty Ltd to vary the registration of this product to include use on capsicum and chillies (collectively classified as peppers by Codex) for the pre-harvest control of fruit fly.

This involves approving a new product label for this product. The application also requires the establishment of Maximum Residue Limits (MRL’s) for trichlorfon and an amendment to the existing milk MRL. The existing Withholding Periods (WHPs) on the current label are applicable for capsicum (sweet peppers) and chillies.

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 this new use 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: Bayer CropScience Pty Ltd
Active Constituent: 500 g/L trichlorfon
Poison Scheduling: Schedule 6
Statement of Claim: For the control of a several insect pests in various situations as specified in the directions for use table.
Pack Size: 20L
Proposed MRLs:

Table 1 MRL (mg/kg)
Milk *0.05

Withholding Period: Harvest (edible crops): DO NOT harvest for two days after application.

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 on the crops proposed would not present an undue hazard to the safety of people consuming treated produce.

Trade Evaluation

The Chemistry and Residue Program of the APVMA has completed an evaluation of residue data and has supported the proposed new Australian MRL and proposed amendment to the current milk MRL for this product and the use pattern.

Major export markets Australian produced peppers include New Zealand, Indonesia and Thailand with a total value of ~$1.7 millon dollars in 1997 through the export of 741 tonnes of produce.

New Zealand is the largest export market for Australian peppers and whilst New Zealand does not have an MRL to cover the use of trichlorfon in peppers, the Trans Tasman Mutual Recognition Agreement between Australia and New Zealand allows for the mutual recognition of food standards including MRL’s.

Prior to 1996, Codex Alimentarius Commission had set an MRL of 1 mg/kg for trichlorfon in peppers, however this MRL was withdrawn due to the lack of support from the manufacturer for its continuation.

Following the finalisation of the US EPA’s Re-registration Eligibility Decision (RED), the existing US tolerance for trichlorfon 0.1 mg/kg was withdrawn.

The proposed use pattern is the same as that currently approved for tomatoes. The trial data supplied in capsicum indicates that residues are not expected to exceed 0.15 mg/kg when trichlorfon is used according to the proposed use pattern. Chillies are in the same Codex commodity group as capsicum and due to the similar morphology of capsicums and chillies it is anticipated that an MRL of 0.2 mg/kg will be sufficient to cover residues in chillies.

The APVMA re-evaluated existing animal commodity MRL’s with respect to existing use patterns in agricultural and veterinary products. As no veterinary use patterns exists for trichlorfon that may result in residues in milk, it is appropriate to consider that the milk MRL is applicable only to the agricultural uses of trichlorfon. As the likelihood of detectable residues in milk resulting from the agricultural use of trichlorfon is small, it is appropriate to revise the milk MRL to *0.05mg/kg, rather than the existing MRL of 0.05mg/kg. However, no change to the MRL’s for cattle (edible offal, fat and meat) is recommended as these MRL’s are influenced by both agricultural and veterinary uses of trichlorfon.

The APVMA is satisfied that if Dipterex 500 SL Insecticide was used on peppers according to label recommendations and Good Agricultural Practice the proposed uses of the product would not unduly prejudice Australia’s export trade.

A Trade Advice Notice (TAN) that includes a more detailed summary of the assessment has been 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 is addressing the following criteria during the evaluation of this application:
Chemistry and Manufacture
Occupational Health and Safety
Environmental Safety
Target Species Efficacy and Safety


The APVMA welcomes comment on whether or not the proposed use of trichlorfon in peppers poses an undue prejudice to Australia’s trade in these commodities.

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

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

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

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