Gazette APVMA 3, 1 March 2005 page 17

NOTICE

Procymidone

[in the products: SUMITOMO SUMISCLEX BROADACRE FUNGICIDE
and SUMITOMO SUMISCLEX 500 FUNGICIDE]

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it applications from Sumitomo Chemical Australia Pty Ltd to vary the registration of these products to include use for control of Sclerotinia rot (Sclerotinia sclerotiorum) in canola. This involves approving new product labels for these products. The applications also require the establishment of Food and Animal Feed MRLs for procymidone and the setting of Withholding Periods (WHPs) for harvest and grazing of treated canola.

The APVMA invites any person to submit a relevant written submission as to whether the applications to vary the registration to extend the use of these products to include the 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 products. Comments must be received by the APVMA within 28 days of the date of this notice.

Particulars of Application

Product Names: SUMITOMO SUMISCLEX BROADACRE FUNGICIDE
SUMITOMO SUMISCLEX 500 FUNGICIDE
Applicant Company: Sumitomo Chemical Australia Pty Ltd
Active Constituent: procymidone
Signal Heading: Schedule 7
Statement of Claim: For the control of Sclerotinia rot (Sclerotinia sclerotiorum) in canola.
Pack Sizes: 1L, 5L, 10L and 20L
Proposed MRLs:

Table 1

Food	MRL (mg/kg)
Rape seed	1
Rape seed oil, crude	2

Table 4

Animal feed commodity	MRL (mg/kg)
Canola forage	5

Withholding Period: Harvest: Not required when used as directed.
Grazing: Do not graze or cut for stock feed for 9 weeks 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 applications 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 these products would not present an undue hazard to the safety of people from either consumption of produce harvested from treated crops or produce from animals whose diet had included forage or fodder from crops treated with these products.

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 these products and the use pattern.

Residues of procymidone in canola seed harvested between 61and 81 days after 1 application ranged from <0.02 mg/kg (the limit of detection) to 0.3 mg/kg the highest residue after a 61-day withholding period. Residues in canola straw were higher, ranging from <0.02 mg/kg, at the longest withholding period of 81 days after treatment (DAT) up to 3.1 mg/kg at 61 DAT. On the basis of the data, MRLs have been recommended for rapeseed at 1 mg/kg. An MRL of 5 mg/kg is recommended for treated canola fodder and forage for animal consumption, with a grazing withholding period of 9 weeks.

Residues data for canola oil was also submitted. Procymidone residues in oil ranged from 0.2 to 1.1 mg/kg. Based on the seed MRL an MRL of 2 mg/kg is recommended for canola oil, crude.

As the products may be applied to canola by aerial spraying, the likely residues in pasture affected by spray drift and consequently in the tissues of animals grazing on that pasture were considered. It was estimated that animals (cattle) grazing on pasture affected by 10% spray drift could develop low but finite residues. The calculations for the potential residue estimates are considered to be conservative, as residues may decline in pasture following application and residues in tissues may decline following livestock exposure to contaminated pasture. Therefore potential trade risk from residues in animal commodities above the recommended MRLs is considered to be low. However a potential risk could remain, and an in crop buffer is recommended by the APVMA as an appropriate means to mitigate the potential trade risk.

With respect to the existing animal commodity MRLs’ the residue data for canola forage and fodder show that the livestock dietary exposure will remain at less than 10 pm in the diet. Therefore no change is recommended, the existing animal commodity MRLs remain acceptable.

The APVMA is satisfied that both SUMITOMO SUMISCLEX BROADACRE FUNGICIDE and SUMITOMO SUMISCLEX 500 FUNGICIDE used according to label recommendations and Good Agricultural Practice the risk to Australia’s export trade associated with the proposed use is considered to be low and acceptable.

A Trade Advice Notice (TAN) 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 from David Hutchison, Tel 02 6271 6384.

Other Criteria

Additionally, the APVMA is addressing the following criteria during the evaluation of these applications:

Occupational Health and Safety Public Health
Target Species Efficacy and Safety Environmental Safety

In addition procymidone is currently under review as notified in the Gazette of December 2004 on page 32. A condition of approval of the new labels containing this new use will be that these labels will be subject to the relevant outcomes of the current review of procymidone.

Submissions

Comments relating to the trade implications of the proposals to grant these applications for variation of registration should be addressed in writing to:

Paul Jung
Pesticides Program
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604

Phone: (02) 6272 3354
Fax: (02) 6272 3218