NRA Gazette 10, 2 October 2001 page 18

NOTICE

Spiroxamine

[in the product: PROSPER 500 EC FUNGICIDE]

The National Registration Authority for Agricultural and Veterinary Chemicals (NRA) has before it an application from Bayer Australia for registration of a new product containing the active constituent Spiroxamine. The product is PROSPER 500 EC FUNGICIDE and is intended for use on grapevines.

In accordance with Sections 12 and 13 of the Agvet Code, the NRA invites any person to submit a relevant written submission as to whether the application for registration should be granted. Submissions should state the grounds on which they are based. Such grounds should relate only to matters outlined below that the NRA is required to take into account in deciding whether to grant the application. Comments must be received by the NRA within 28 days of the date of this notice.

Particulars of Application

Proposed product name: PROSPER 500 EC FUNGICIDE
Applicant company: Bayer Australia
Name of active constituent: Spiroxamine
Signal heading: Schedule 6
Pack sizes: 1, 5, 10 and 20Kg
Withholding Period: Gapevines: DO NOT harvest for 4 weeks after application.
Statement of claims: For the control of powdery mildew on
grapevines

Summary of the NRA's evaluation of PROSPER 500 EC FUNGICIDE in accordance with Section 14(3)(e) and (f) of the Agricultural and Veterinary Chemicals Code (the 'Agvet Code'), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994

The NRA has evaluated the application and in its assessment in relation to human and environmental safety under section 14(3)(e) of the Agvet Code, it proposes to determine that:

(i) The NRA is satisfied that the proposed use of PROSPER 500 EC FUNGICIDE would not be an undue hazard to the safety of people exposed to it during its handling and use.

The product will be formulated in Australia.

Spiroxamine has been determined to be a hazardous substance according to NOSHC Approved Criteria for Classifying Hazardous Substances.

National Occupational Health and Safety Commission (NOHSC) have conducted a risk assessment on PROSPER 500 EC FUNGICIDE and concluded that it can be used safely.

The NRA has considered the findings of the NOHSC evaluation and accepts its recommendations on this criterion.

(ii) The NRA is satisfied that the proposed use of PROSPER 500 EC FUNGICIDE will not be an undue hazard to the safety of people using anything containing its residues. Residue data was assessed by the NRA and Maximum Residue Limits (MRLs) and Withholding Periods (WHPs) were set for spiroxamine when used on grapevines.

(iii) The NRA is satisfied that the proposed use of PROSPER 500 EC FUNGICIDE is not likely to be harmful to human beings if used according to the product label directions.

The active constituent spiroxamine has been evaluated and approved by the NRA. It is a Schedule 6 poison. The appropriate Signal Heading appears on the label. First Aid and Safety Directions have been recommended by the Commonwealth Department of Health and Aged Care and NOHSC, and have been included on the labels.

The NRA has considered the findings of its advisers and accepts their recommendations on this criteria.

(iv) The NRA is satisfied that the proposed use of PROSPER EC 500 FUNGICIDE for control of powdery mildew in grapevines as per the directions for use on the label would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment.

Environment Australia has assessed environmental fate and toxicity data in support of PROSPER 500 EC FUNGICIDE, which show that residues of spiroxamine are not expected to result in primary poisonings of terrestrial or aquatic wildlife. Studies indicate spiroxamine is metabolised relatively quickly by soil enzymes and microorganisms to a range of compounds. Parent compound and metabolites have low mobility in soil. Despite very high toxicity to green algae and moderate toxicity to aquatic plants and fish, the situation and application rate in grapevines results in an acceptable enviromental hazard level. The high toxicity to some organisms, particularly algae, is also mitigated through label restrictions, where a maximum of two applications per season and the avoidance of spray drift onto natural water bodies are expected to result in an acceptable hazard.

The NRA has considered the findings of Environment Australia and accepts its recommendations based on these criteria.

(v) The NRA is considering the potential impact of the proposed use of PROSPER 500 EC FUNGICIDE on trade between Australia and places outside Australia. There are currently no CODEX MRLs set for spiroxamine. Comment is sought from industry.

In relation to its assessment of efficacy under section 14(3)(f), the NRA proposes to determine that:

(i) The NRA is satisfied the data from trials supporting the efficacy of PROSPER 500 EC FUNGICIDE adequately demonstrates that under local conditions, when used as directed, this product is effective for the proposed uses.

Public Release Summary

A Public Release Summary of the evaluation is available by contacting David Hutchison on telephone (02) 6271 6384. Written submissions on the NRA's proposal to grant the application for registration should be addressed in writing to:

Larissa Cahill
Agricultural &Veterinary Chemicals Evaluation
National Registration Authority for Agricultural and Veterinary Chemicals
PO Box E240
KINGSTON ACT 2604

Phone: (02) 6272 3747
Fax: (02) 6272 3218