Gazette APVMA 6, 7 June 2005 page 19

NOTICE

 

cyhalofop-butyl

[in the product: BARNSTORM HERBICIDE]

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Dow AgroSciences Australia Ltd for registration of a new product containing the active constituent cyhalofop-butyl. The product, BARNSTORM HERBICIDE, is for post-emergence control of certain grasses in rice .

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: BARNSTORM HERBICIDE
Applicant company: Dow AgroSciences Australia Ltd
Name of active constituent: cyhalofop-butyl
Signal heading: Schedule 5
Statement of claims: For the post-emergence control of barnyard grasses and silver top in rice
Pack sizes: 5, 10 and 20 litres
Withholding period:

Harvest: Not required when used as directed
Grazing. Do not graze or cut for stock food for 8 weeks after application

Summary of the APVMA’s evaluation of BARNSTORM 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 BARNSTORM 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 BARNSTORM HERBICIDE and concluded that it can be used safely.

The product will be formulated in New Zealand in fluorinated high-density polyethylene (HDPE) containers. Repackaging will not be required in Australia.

BARNSTORM HERBICIDE is determined to be a hazardous substance according to the OCS (OHS) criteria. Contact with the eyes will cause damage and it will irritate the nose, throat and skin. Personal Protective Equipment statements for the Safety Directions of BARNSTORM 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 BARNSTORM HERBICIDE will not be an undue hazard to the safety of people using anything containing its residues. Residue data was assessed by the APVMA and Maximum Residue Limits (MRLs) and Withholding Periods (WHPs) were set for cyhalofop-butyl in BARNSTORM HERBICIDE, when used on rice.

The recommended WHPs have been placed on the draft label and MRLs recommended for rice (0.01 mg/kg), animal commodities (0.05 mg/kg) and the animal feed commodities rice straw (0.2 mg/kg) and rice forage (0.1 mg/kg). Detectable residues are not expected to occur in animal commodities relevant to the proposed use pattern for this product.

(iii) The APVMA is satisfied that the proposed use of the active constituent cyhalofop-butyl in BARNSTORM 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 cyhalofop-butyl and BARNSTORM 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 Barnstorm Herbicide, containing the new active constituent cyhalofop-butyl, 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 in support of the proposed use and has concluded that the risks to the environment from the proposed use are acceptable.

Cyhalofop-butyl is only slowly hydrolysed under acidic conditions but rapidly hydrolysed in alkaline conditions. It is not photolysed in natural sunlight. It is rapidly degraded in aerobic soil and water and under anaerobic conditions. Cyhalofop-butyl is strongly adsorbed and is immobility in soil. The major metabolites were shown to be significantly more mobile than the parent but also rapidly degrade in soil and therefore unlikely to leach.

Cyhalofop-butyl is moderately to highly toxic to fish, aquatic invertebrates, algae and duckweed. It is non-toxic to birds and is practically harmless to beneficial arthropods. There was no toxicity to soil micro-organisms or mammals. As expected for a selective grass herbicide, it is likely to be herbicidal to non-target grasses but not other plants.

No acute or chronic hazard is expected for birds, earthworms, honeybees, soil micro-organisms and arthropods. Spray drift is not expected to pose an unacceptable hazard to fish, aquatic invertebrates, aquatic plants, algae or other aquatic organisms when used according to label directions for rice. The risks from runoff are considered low. Leaching and the potential concentrations in groundwater are likely to be extremely low.

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 cyhalofop-butyl in BARNSTORM HERBICIDE would not adversely affect trade between Australia and places outside Australia.

Codex has not established MRLs for cyhalofop-butyl. The proposed Australian MRLs are below those established in the major export markets for Australian rice. It is anticipated that rice and its processed commodities could be used as animal feeds. Detectable residues are not expected in feed commodities with the observance of the recommended withholding periods.

Hence detectable residues are not expected to occur in livestock consuming rice or the commodities derived from rice.

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 BARNSTORM 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