Gazette APVMA 5, 3 May 2005 page 16

NOTICE

Octenol

[in the product: Mosquito Magnet Octenol Biting Insect Attractant]

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from American Biophysics Corporation for registration of a new product containing the active constituent Octenol. The product Mosquito Magnet Octenol Biting Insect Attractant is intended for the purposes of attracting mosquitoes and biting midges to the Mosquito Magnet trapping device.

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 this Notice.

Particulars of Application

Proposed product name: Mosquito Magnet Octenol Biting Insect Attractant
Applicant company: American Biophysics Corporation
Name of active constituent: Octenol
Poisons Scheduling: Schedule 6
Statement of claims: For the purposes of attracting mosquitoes and biting midges to the Mosquito Magnet trapping device
Pack sizes: 6mL (3 cartridges – 2mL per cartridge)
Withholding period: Not required when used as directed.

Summary of the APVMA’s evaluation of MOSQUITO MAGNET OCTENOL BITING INSECT ATTRACTANT 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 Mosquito Magnet Octenol Biting Insect Attractant would not be an undue hazard to the safety of people exposed to it during its handling and use.

The Office of Chemical Safety (OCS) has conducted a risk assessment on MOSQUITO MAGNET OCTENOL BITING INSECT ATTRACTANT and concluded that it can be used safely when used in accordance with the label instructions.

MOSQUITO MAGNET OCTENOL BITING INSECT ATTRACTANT has a moderate oral toxicity, low dermal and inhalation toxicity, may be an eye irritant but is not a skin sensitizer or skin irritant.

Octenol is a naturally -occurring compound found in plants, animals, edible fruits and vegetables, widely used as a flavouring ingredient in foods and is approved by the US FDA as a direct food additive, and is also approved by the Council of Europe as an artificial flavouring agent.

The octenol attractant in the product is pacaged in a covered plastic (PET) tray. The product is designed to control the release of octenol at a low rate, which is considered attractive to pests. Accordingly, the dermal exposure from the use of product is minimal even with the occasional need for operators to position and/or service the Mosquito Magnet trapping device.

Based on the risk assessment, the following Hazard statements have been recommended: “Harmful if swallowed. Wash hands after use.” No Personal Protective Equipment (PPE) have been considered necessary and none are recommended.

The APVMA accepts the findings and recommendations of the OCS evaluation.

(ii) The APVMA is satisfied that the proposed use of MOSQUITO MAGNET OCTENOL BITING INSECT ATTRACTANT will not be an undue hazard to the safety of people using anything containing its residues. The product will not be applied to crops or animals.

(iii) The APVMA is satisfied that the proposed use of MOSQUITO MAGNET OCTENOL BITING INSECT ATTRACTANT is not likely to be harmful to human beings if used according to the product label directions.

The active constituent Octenol has been evaluated and approved by the APVMA, and the product has been placed in Schedule 6 of the SUSDP. The appropriate signal heading is included on the label. First aid and safety directions for octenol have been recommended by the Commonwealth Department of Health and Ageing and have been included on the proposed label.

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

(iv) The APVMA is satisfied that the proposed use of MOSQUITO MAGNET OCTENOL BITING INSECT ATTRACTANT for the purposes of attracting mosquitoes and biting midges to the Mosquito Magnet trap is not likely to have an unintended effect that is harmful to animals, plants or the environment.

The Department of Environment and Heritage (DEH) has assessed data in support of the proposed use and has concluded that the use as proposed is unlikely to have an unintended effect that is harmful to the environment . The applicant estimated that the proposed use would add less than 100kg of octenol to the environment each year. This is not likely to increase the environmental load given the natural and incidental releases of this chemical. Octenol is produced by ruminants in general, and then released into the environment as a component of the animal’s breath. Additionally octenol has been isolated from plants. Incidental release of octenol arises from food such as cheese and various flavourings.

DEH assessment indicated that, given the limited volumes of use, any impacts on non-target insects are expected to be minimal and unlikely to affect populations of such insects.

The APVMA accepts the findings and recommendations of its advisors on this criterion.

(v) The APVMA is satisfied that the proposed use of MOSQUITO MAGNET OCTENOL BITING INSECT ATTRACTANT would not unduly prejudice trade between Australia and places outside Australia as the product is not for use on any majorAustralian export 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 MOSQUITO MAGNET OCTENOL BITING INSECT ATTRACTANT adequately demonstrate that under local conditions this product is effective for the proposed uses.

Submissions
Written submissions on the APVMA’s proposal to grant the application for registration should be addressed to:

Laura Leis
Pesticides Program
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604

Phone: (02) 6272 5295
Fax: (02) 6272 3218