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Gazette APVMA 4, 3 April 2007 - Page 15
NOTICE
Flufenoxuron
in the product: FLUROX TERMITE BAIT
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Janssen-Cilag Pty Ltd for registration of a new product containing the active constituent flufenoxuron. The product is FLUROX TERMITE BAIT. The product is for use by professional pest controllers as part of a termite baiting system for the management of subterranean termite infestations.
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: | Flurox Termite Bait | ||
| Applicant company: | Janssen-Cilag Pty Ltd | ||
| Name of active constituent: | Flufenoxuron | ||
| Signal heading: | Unscheduled | ||
| Statement of claims: | For use as part of a termite interception and baiting system for the management of subterranean termite infestations. | ||
| Pack sizes: | 1.6kg, 6kg | ||
| Withholding period: | N/A | ||
Summary of the APVMA’s evaluation of FLUROX TERMITE BAIT 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 FLUROX TERMITE BAIT 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 (OCS) has conducted a risk assessment on FLUROX TERMITE BAIT and concluded that it can be used safely. The APVMA accepts the findings and recommendations of the OCS evaluation.
The product will be formulated Overseas; repackaging will not be required in Australia.
(ii) The APVMA is satisfied that the proposed use of FLUROX TERMITE BAIT will not be an undue hazard to the safety of people using anything containing its residues. The product is not intended for use on food commodities and Maximum Residue Limits (MRLs) and Withholding Periods (WHPs) were not required to be set for FLUROX TERMITE BAIT when used as part of a termite baiting system.
(iii) The APVMA is satisfied that the proposed use of the product FLUROX TERMITE BAIT is not likely to be harmful to human beings if used according to the product label directions.
The active constituent flufenoxuron has been evaluated and approved, the active is of low acute toxicity, and has been exempted from inclusion in a poison schedule. As such the product is not required to be a scheduled poison. At the low concentration in the product, formulation composition, form of presentation of the product and proposed use pattern, it was determined that First Aid and Safety Directions for flufenoxuron need not be specified for this product.
The APVMA accepts the findings and recommendations of its advisers on this criteria.
(iv) The APVMA is satisfied that the proposed use in bait stations of FLUROX TERMITE BAIT by professional pest controllers in intergrated termite management programs in and around buildings, utility poles, logs, tree stumps, or termite mounds is not likely to have an unintended effect that is harmful to animals, plants or the environment.
Environment Australia has assessed data in support of FLUROX TERMITE BAIT and believes that the application contains adequate environmental fate and toxicity data to demonstrate that the use of FLUROX TERMITE BAIT according to the label is unlikely to result in primary poisonings of terrestrial or aquatic wildlife.
The APVMA accepts the findings and recommendations of its advisers on this criteria.
(v) The APVMA is satisfied that the proposed use of FLUROX TERMITE BAIT would not adversely affect trade between Australia and places outside Australia as the product is not intended for use on 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 FLUROX TERMITE BAIT adequately demonstrates that under local conditions this product is effective for the proposed uses.
Written submissions on the APVMA’s proposal to grant the application for registration should be addressed in writing to:
Paul Jung
Pesticides Program
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604
Phone: (02) 6210 4752
Fax: (02) 6210 4776