Gazette APVMA 8, 1 August 2006 page 21

NOTICE

MILBEMECTIN

[in the product: Summit Ultiflora Miticide]

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Summit Agro Australia Pty Ltd for registration of a new product: Summit Ultiflora Miticide containing the active constituent milbemectin. The product is intended for control of Two-spotted Mite (Tetranychus urticae) on Roses, Chrysanthemums and Carnations. In accordance with section 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 this notice.

Particulars of Application

Proposed product name: Summit Ultiflora Miticide
Applicant company: Summit Agro Australia Pty Ltd
Name of active constituent: Milbemectin
Signal heading: Schedule 5
Statement of claims: For control of Two-spotted mite (Tetranychus urticae) on Roses, Chrysanthemums and Carnations.

Pack sizes: 500mL, 2L, 5L, 10L.
Withholding period: N/A

Summary of the APVMA’s evaluation of the four products 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 the product would not be an undue hazard to the safety of people exposed to the product during its handling and use.

The Office of Chemical Safety (OCS) of the Department Of Health and Ageing has conducted a risk assessment on the product and concluded that it can be used safely when used in accordance with the prescribed safety directions. The APVMA accepts the findings and recommendations of the OCS evaluation.

(ii) No residues assessment was required for the product as the products proposed use is non-food. The APVMA is satisfied that the proposed use of the product will not be an undue hazard to the safety of people using anything containing its residues.

The APVMA is satisfied that the proposed use of the active constituent, milbemectin, is not likely to be harmful to human beings if used according to the product label directions.

The active constituent milbemectin has been evaluated and approved. The product has been placed in Schedule 5 of the Standard for the Uniform Scheduling of Drugs and Poisons. The appropriate signal heading appears on the product draft label. First aid a safety directions have been recommended by OCS and have been included on the draft label.

The APVMA accepts the findings and recommendations of its advisers to matters concerning public health.

The APVMA is satisfied that the proposed use of the product as a miticide is not 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. Milbemectin is degraded at a moderate rate under aerobic conditions in soil and water but under anaerobic conditions there is little degredation. Milbemectin is strongly adsorbed to the soil and does not bioaccumulate. It was rated as moderately toxic to birds, green algae and earthworms, highly toxic to duckweed and very highly toxic to fish and aquatic invertebrates. It was rated as harmful to honey bees and parasitic mites but was harmless to green lacewings, parasitic wasps, predatory bug and a ground dwelling predatory beetles. There was no significant toxicity to soil micro-organisms or to plants. It is concluded the proposed use of the product is not expected to pose an unacceptable hazard to fish, aquatic invertebrates, aquatic plants, algae or other aquatic organisms via spraydrift with an appropriate spraydrift buffer of 10 metres.

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

(v) The APVMA is satisfied that the proposed use of the products would not unduly prejudice trade between Australia and places outside Australia as the products proposed use is non-food and not for use on any export commodity.

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 the product adequately demonstrates that under local conditions the product is effective for the proposed use.

Written submissions on the APVMA’s proposal to grant these applications for registration should be addressed in writing to:

Gavin Hall
Agricultural &Veterinary Chemicals Evaluation
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604
Phone: (02) 62723152
Fax: (02) 62723218
E-mail: gavin.hall@apvma.gov.au