Gazette APVMA 8, 2 August 2005 page 20

NOTICE

quinclorac

in the product: DRIVE HERBICIDE

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from BASF Australia Ltd for registration of a new product containing the new active constituent quinclorac. The product, DRIVE HERBICIDE, is for post-emergence control of summer grass and white clover in turf.

In accordance with sections 12 and 13 of the Agvet Code, the APVMA 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 APVMA is required to take into account in deciding whether to grant the application. Comments must be received by the APVMA within 28 days of the date of this notice.

Particulars of Application
Proposed product name: DRIVE HERBICIDE
Applicant company: BASF Australia Ltd
Name of active constituent: quinclorac
Signal heading: Schedule 5
Statement of claims: For the post-emergence control of summer grass and white clover in turf
Pack sizes: 250g, 500g, 1kg, 2kg, 5kg

Summary of the APVMA’s evaluation of DRIVE HERBICIDE 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 APVMA 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 APVMA is satisfied that the proposed use of DRIVE HERBICIDE would not be an undue hazard to the safety of people exposed to it during its handling and use.

The Department of Health and Ageing, Office of Chemical Safety (Occupational Health and Safety) [OCS (OHS)] section has conducted a risk assessment on DRIVE HERBICIDE and concluded that it can be used safely.

The product will be formulated in USA in will be packaged in fluorinated high-density polyethylene (HDPE) bottles.

DRIVE HERBICIDE is determined to be a hazardous substance according to the OCS (OHS) criteria. The product is a skin irritant and a sensitiser. Personal Protective Equipment statements for the Safety Directions of DRIVE HERBICIDE have been recommended by the OCS (OHS) section, and have been included on the draft label.

The APVMA has considered the OCS (OHS) assessment and accepts its findings and recommendations.

(ii) The APVMA is satisfied that the proposed use of DRIVE HERBICIDE will not be an undue hazard to the safety of people using anything containing its residues. The product is intended for use on turf only and not in any situation that might result in residues occurring in foods for human consumption.

(iii) The APVMA is satisfied that the proposed use of the active constituent quinclorac in DRIVE HERBICIDE is not likely to be harmful to human beings if used according to the product label directions.

The proposed product has been assessed by the National Drugs and Poisons Scheduling Committee and has been included in Schedule 5. The appropriate Signal Heading is on the label. First Aid and Safety Directions (hazard statements) for quinclorac and DRIVE HERBICIDE have been recommended by the Commonwealth Department of Health and Ageing, OCS (Toxicology) section, and have been included on the draft label.

The APVMA has considered the findings of its advisers on this criterion and accepts their recommendations.

(iv) The APVMA is satisfied that the proposed use of new product DRIVE HERBICIDE, containing the new active constituent quinclorac, would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment.

The Department of the Environment and Heritage has assessed data submitted in support of the registration of DRIVE HERBICIDE, as well as information in the public domain. Assessment indicates that quinclorac is unlikely to persist in soils under turf because of microbial metabolism. Some leaching from surface soils may occur, as quinclorac is highly mobile in soils. Some volatilisation may also occur, as quinclorac is transformed to its more volatile methyl ester in soils.

Quinclorac has low toxicity to most nontarget organisms but highly toxic to plants.

Modelling indicates that damage from spray drift is unlikely, particularly as labels instruct users to avoid situations in which nontarget plants may be exposed to spray drift.

The APVMA has considered the findings of the Department of the Environment and Heritage and accepts its recommendations on this criterion.

(v) The APVMA is satisfied that the proposed use of quinclorac in DRIVE HERBICIDE would not adversely affect trade between Australia and places outside Australia as the product is not for use on any major Australian export food commodities.

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

(i) The APVMA is satisfied the data from trials supporting the efficacy of DRIVE HERBICIDE adequately demonstrate that under Australian conditions, this product will be effective for the proposed uses.

Public Release Summary
A Public Release Summary (PRS) of the evaluation is available on the APVMA website, www.apvma.gov.au or by contacting David Hutchison on telephone (02) 62716384. Submissions on the APVMA’s proposal to grant the application for registration should be in writing and addressed to:

Ranjit Gajanayake
Pesticides Division
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604

Phone: (02) 62725567
Fax: (02) 62723218
email: ranjit.gajanayake@apvma.gov.au