Gazette APVMA 12, 6 December 2005 page 16

NOTICE

Diphacinone

[in the product: Ramik Green Bait Bits Rodenticide]

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Hacco Inc./Neogen Corporation for registration of a new product containing the new active constituent Diphacinone. The product is intended for control of mice in and around industrial, commercial, agricultural and domestic buildings.

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 applications. Comments must be received by the APVMA within 28 days of this notice.

Particulars of Application
Proposed product name: Ramik Green Bits Rodenticide
Applicant company: Hacco Inc./Neogen Corporation
Name of active constituent: Diphacinone
Poison Scheduling: Schedule 6
Statement of claims: For control of mice in and around industrial, commercial, agricultural and domestic buildings.
Pack sizes: 50g, 100g, 300g, 600g, 1.5kg, 2.5kg, 4kg, 7.5kg, 10kg & 24kg

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 or its residues during or as a result of their handling and use.
The Office of Chemical Safety (OCS) has conducted an assessment of the product with respect to its toxicity, the exposure to it via occupational handling and use and the associated risks. The OCS concluded that the productcan be used safely when used in accordance with the prescribed safety directions. The APVMA accepts the findings and recommendations of the OCS evaluation.
An assessment of the risks posed from residues in food was not required for the product as the proposed use will not result in any contact of the products with food. The APVMA is therefore satisfied that the proposed use of the product will not be an undue hazard to the safety of people from consuming food.

(ii) The APVMA is satisfied that the proposed use of the product is not likely to be harmful to human beings if used according to the product label directions.
The active constituent Diphacinone has been evaluated and approved (Approval number 54768, 2 May 2005). Products containing Diphacinone have been placed in Schedule 6 of the Standard for the Uniform Scheduling of Drugs and Poisons (ie substances with a moderate potential for causing harm, the extent of which can be reduced through the use of distinctive packaging with strong warning and safety directions on the label). As a result the appropriate Schedule 6 signal heading and safety directions appear on all product labels. First aid instructions appropriate for an anticoagulant have been recommended by OCS and have also been included on the draft labels.

(iii) The APVMA is satisfied that the proposed use of the product as a rodenticide is not likely to have an unintended effect that is harmful to animals, plants or things, or to the environment. The Department of Environment and Heritage (DEH) has advised that environmental exposure to Diphacinone will be low due to the proposed use in and around buildings. Primary exposure to non-target animals will be low, provided care is taken to follow label instructions and place baits only in areas inaccessible to non-target animals. Although secondary exposure to animals via predation on poisoned rodents is harder to control, the restricted use around buildings is designed to minimise impact on populations of rodent predators and as such is not considered an undue risk. The APVMA has considered the findings of DEH and accepts these conclusions.

(iv) The APVMA is satisfied that the proposed use of the products would not unduly prejudice trade between Australia and places outside Australia as the proposed use of the products are not expected to result in residues in 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 uses. Results were provided from trials conducted both in Australia and overseas. The trials were conducted, on the nominated rodent pests, adequately designed, carried out and analysed, and in situations considered comparable to commercial reality in Australia. The data demonstrated an acceptable level of control and that the product will be effective as claimed when used in accordance with label instructions.

Written submissions on the APVMA’s proposal to grant these applications for registration should be addressed in writing to:
Gavin Hall
Pesticide Program
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604
Phone: (02) 6272 3152
Fax: (02) 6272 3218
E-mail: gavin.hall@apvma.gov.au