Gazette APVMA 5, 3 May 2005 page 19

NOTICE

Epoxiconazole
[in the product: OPUS 125 FUNGICIDE]

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from BASF Australia to register a new product OPUS 125 FUNGICIDE for use on wheat and barley to control fungal diseases. The product contains 125 g/L epoxiconazole as the active constituent. The application requires the establishment of Maximum Residue Limits (MRLs) for epoxiconazole in wheat and barley grain, wheat bran and germ, and various animal food and feed commodities. The active constituent epoxiconazole is currently approved for use on banana crops.

The APVMA invites any person to submit a relevant written submission as to whether the application to register the product and 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 Applications

Product Name: OPUS 125 FUNGICIDE
Applicant Company: BASF Australia
Active Constituent: epoxiconazole
Signal Heading: Schedule 5
Pack Sizes: 1, 5, 10, 20, 110, 1000L
Statement of claims: For the control of leaf rust, stripe rust and Septoria blotch of wheat and leaf rust and spot form of net blotch of barley.

Proposed epoxiconazole MRLs:

Table 1

Food MRL (mg/kg)
Barley 0.5
Edible offal (mammalian) 0.05
Eggs *0.01
Milks 0.01
Poultry meat (in the fat) 0.05
Poultry, edible offal of 0.02
Wheat 0.5
Wheat bran, unprocessed 3
Wheat germ 2

Table 4

Animal Feed Commodity MRL (mg/kg)
Barley forage, green 5
Barley straw and fodder, dry 7
Wheat forage, green 5
Wheat straw and fodder, dry 7

Withholding Periods:

Barley, Wheat - DO NOT harvest for 5 weeks after application.DO NOT graze or cut for stock food for 5 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 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 Residue Evaluation Section of the APVMA has completed an evaluation of the data and has supported the proposed MRLs.

Trade Evaluation

Grain
A large number of residue trials were evaluated and indicated that residues in grain may frequently be less than the limit of quantitation. The optimal use pattern recommended for the product is for application to be around flag leaf emergence stage (ZGS39). Residues were not detected in the majority of crops treated prior to the end of flowering. However, detectable residues were observed in some trials where the pre-harvest interval was around 35 days (ie. equivalent to the proposed withholding period). Industry input on the potential for undue prejudice to trade in grain is therefore sought.

Animal commodities
Livestock could be exposed to epoxiconazole in the diet through consumption of grain, forage or straw from treated crops. Detectable residues resulting from any of the livestock exposure scenarios are only expected to occur in milk and liver of cows and sheep. In all cases, the predicted residues are low, even when based on worst-case assumptions.

In lactating cows dosed at 10´ the level expected through use of OPUS 125 FUNGICIDE, residues in liver and milk declined to undetectable levels within 2 days of removal from dosing. Residues in meat and fat were negligible, even at highly exaggerated dietary exposures. It is concluded that the risk of detectable residues being observed in export animal commodities is low.

Residues in poultry are expected to be undetectable as a result of normal feeding practices. MRLs above the limit of quantitation have been recommended for poultry meat and offal based on worst-case assumptions.

Grazing livestock could be exposed to dietary residues of epoxiconazole as a result of grazing pastures affected by spray drift from cereal crops treated in close proximity to grazing areas. Opus 125 Fungicide will be applied by both ground and aerial techniques. Given the rapid depletion profile of epoxiconazole and the exaggerated assumption of 10% drift, it is considered unlikely that detectable residues would occur in livestock as a result of spray drift onto pasture or crops not otherwise treated with epoxiconazole.

The risk to Australia’s export trade in animal commodities is considered to be low.

Comments are sought on the potential for OPUS 125 FUNGICIDE to unduly prejudice Australian export trade when it is used to control fungal diseases of barley and wheat.

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 applications. Copies of the TAN are available on request.

Other Criteria

Additionally, the APVMA has addressed the following criteria during the evaluation of this and previous applications:

Chemistry & Manufacture, Toxicology, Occupational Health and Safety, Environmental Safety and Target Species Efficacy and Safety

Submissions

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
KINGSTON ACT 2604

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