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Sodium Fluoroacetate (1080) REVIEW FINDINGS SODIUM FLUOROACETATE TECHNICAL REPORT The reconsideration of registrations of products containing sodium fluoroacetate and approvals of their associated labels. Environmental Assessment January 2008 REVIEW FINDINGS SODIUM FLUOROACETATE TECHNICAL REPORT The reconsideration of registrations of products containing sodium fluoroacetate and approvals of their associated labels. Environmental Assessment January 2008 © Commonwealth of Australia 2007 This work is copyright. Apart from use permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Australian Pesticides and Veterinary Medicines Authority (APVMA). Requests and enquiries regarding reproduction and rights should be addressed to the APVMA’s Chemical Review Program Manager. This document is published by the APVMA. In referencing this document the APVMA should be cited as both author and publisher. Comments and enquiries may be directed to: Manager Chemical Review Australian Pesticides & Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Australia Telephone: +61 2 6210 4700 Facsimile: +61 2 6210 4776 Email: [email protected] Web site: http://www.apvma.gov.au FOREWORD The APVMA is an independent statutory authority with responsibility for the regulation of agricultural and veterinary chemicals in Australia. Its statutory powers are provided in the Agvet Code scheduled to the Agricultural and Veterinary Chemicals Code Act, 1994. The APVMA can reconsider the approval of an active constituent, the registration of a chemical product or the approval of a label for a container for a chemical product at any time. This is outlined in Part 2, Division 4 of the Agvet Code. The basis for the reconsideration is whether the APVMA is satisfied that continued use of products containing sodium fluoroacetate (1080) in accordance with the instructions for their use “would not be likely have an unintended effect that is harmful to animals, plants or things or to the environment” (s34 (1)(a)iii). The requirements for continued approval of a label for containers for a chemical product are that the label contains adequate instructions (s34(1)c). Such instructions include: • the circumstances in which the product should be used • how the product should be used • times when the product should be used • frequency of the use of the product • the withholding period after the use of the product • disposal of the product and its container • safe handling of the product. A reconsideration may be initiated when new research or evidence has raised concerns about the use or safety of a particular chemical, a product or its label. The process for reconsideration includes a call for information from a variety of sources, a review of that information and, following public consultation, a decision about the future use of the chemical or product. In undertaking reviews, the APVMA works in close cooperation with advisory agencies including the Office of Chemical Safety (OCS) within the Department of Health and Ageing, the Department of the Environment and Heritage (DEH), and State Departments of Agriculture as well as other expert advisors, as appropriate. In this case, the APVMA obtained expert advice from the DEH who assessed the information submitted to the review and provided advice on measures to avoid or minimise harmful environmental effects. The APVMA has a policy of encouraging openness and transparency in its activities and community involvement in decision-making. The publication of review reports is a part of that process. The APVMA also makes these reports available to the regulatory agencies of other countries as part of bilateral agreements. Under this program it is proposed that countries receiving these reports will not utilise them for registration purposes unless they are also provided with the raw data from the relevant applicant. This document is Part 2 of ‘The Reconsideration of Registrations of Products Containing Sodium Fluoroacetate (1080) and Their Associated Labels – Preliminary Review Findings, Technical Report’ and relates to all products containing 1080 that have been nominated for review by the APVMA. The review’s findings and recommendations are based on information collected from a variety of sources. APVMA iii The Preliminary Review Findings report containing the APVMA’s preliminary assessments (The Reconsideration of Registrations of Products Containing Sodium Fluoroacetate (1080) and Their Associated Labels, Volume I) and the technical reports (Volume II) for all registrations and approvals relating to 1080 are available from the APVMA website: http://www.apvma.gov.au/chemrev/chemrev.html. iv APVMA CONTENTS FOREWORD iii 1 INTRODUCTION 1 2 CONTEXT 2 2.1 Vertebrate Pests Committee 2 2.2 Environmental Risk Management Authority 3 3 CHEMICAL IDENTITY AND PROPERTIES 4 4 FORMULATION 5 5 ENVIRONMENTAL EXPOSURE 7 5.1 Environmental Release 7 5.1.1 Volume 7 5.1.2 Application and use pattern 7 5.2 Environmental Chemistry and Fate 18 5.2.1 Natural occurrence 18 5.2.2 Persistence in baits 19 5.2.3 Uptake and movement of meat baits 21 5.2.4 Metabolism 22 5.2.5 Residues 24 5.2.6 Mobility in soils 29 5.3 Summary of environmental exposure 30 6 ENVIRONMENTAL EFFECTS 32 6.1.1 Avian toxicity 33 6.1.2 Aquatic toxicity 41 6.1.3 Terrestrial invertebrates 41 6.1.4 Mammals 42 6.1.5 Reptiles 55 6.1.6 Plants 55 6.1.7 Summary of environmental effects 55 7 ENVIRONMENTAL HAZARD 57 7.1 Hazard assessment based on laboratory data 57 7.1.1 Primary poisoning hazard 57 7.1.2 Secondary poisoning hazard 61 7.2 Hazard assessment based on field data 62 7.2.1 Bait uptake studies 63 7.2.2 Carcass searches and incident reports 67 7.2.3 Radiotracking of nontarget animals 68 7.2.4 Population monitoring 72 APVMA v 7.3 Summary of environmental hazard 78 7.4 Alternatives to 1080 79 7.5 Environment Protection and Biodiversity Conservation Act 1999 80 8 LABELLING 82 8.1 Rabbit (and native herbivore) control 82 8.1.1 Rabbait (50304) 82 8.1.2 Victoria 82 8.1.3 South Australia 83 8.1.4 Western Australia 83 8.1.5 Tasmania (42458) 83 8.2 Fox control 84 8.2.1 Foxoff 84 8.2.2 Victoria 84 8.2.3 South Australia 84 8.2.4 Western Australia 84 8.2.5 New South Wales 85 8.3 Wild dog control 85 8.3.1 Doggone (49384) 85 8.3.2 Victoria 86 8.3.3 Western Australia 86 8.3.4 New South Wales 86 8.4 Feral pig control 86 8.4.1 Victoria 86 8.4.2 Western Australia 87 8.5 Variations to labels 87 8.5.1 Grain and vegetable baits 87 8.5.2 Meat baits 87 9 PUBLIC SUBMISSIONS AND VIEWS 89 9.1 Initial submissions 89 9.2 Responses to preliminary review findings 90 9.2.1 Bait shyness and free feeding 90 9.2.2 Risk to nontarget native animals 91 9.2.3 Efficacy 92 9.2.4 Biodiversity conservation 93 9.2.5 Humaneness 94 9.2.6 Secondary poisoning 94 9.2.7 Spotted-tailed quolls 96 9.2.8 Dingoes 97 9.2.9 Domestic dogs 98 9.2.10 Human safety 98 9.2.11 South Ballina beaches 99 9.2.12 Tasmania 99 vi APVMA 9.2.13 Proposed review recommendations 100 10 CONCLUSIONS 107 11 RECOMMENDATIONS 111 11.1 Reconsideration of Registration and Label Approval 111 11.1.1 Variation to labels 111 11.2 Related matters 112 11.2.1 Regulatory control 113 11.2.2 Adverse experience reporting program 113 11.2.3 VPC review recommendations 113 REFERENCES 114 RESPONDENTS TO PRELIMINARY REVIEW FINDINGS 124 APVMA vii Sodium Fluoroacetate—Technical Report 1 INTRODUCTION The National Registration Authority (NRA, now known as the APVMA – Australian Pesticides and Veterinary Medicines Authority) announced in the NRA Gazette of 4 December 2001 that a reconsideration of sodium fluoroacetate would be initiated in early 2002 due to environmental concerns. Sodium fluoroacetate, commonly known as compound 1080, is widely used in Australia for vertebrate pest control. It was selected for reconsideration because of concerns regarding the poisoning of non-target animals, either through the direct taking of baits or the consumption of poisoned animals. The Gazette notice invited submissions in relation to any issue concerning sodium fluoroacetate, but in particular on how it is used in practice, the measures taken to decrease non-target animal exposure, poisoning incident reports, and information on the persistence of the chemical in baits under different conditions and its toxicity to native species. An associated media release highlighted the use of sodium fluoroacetate for fox control. Information provided in response to the Gazette notice was taken into consideration during the drafting of a background and scope document, which was released by the NRA in July 2002. The scope of the review was defined as environmental aspects, animal welfare considerations, and assessment of product labels and associated extension material. The environmental aspects identified in the document include the persistence of 1080 in baits and poisoned animals, effects on non-target animal populations (particularly mammals, with a focus on native carnivores such as quolls and phascogales), consideration of incident reports, and the effectiveness of 1080 as a vertebrate pest control agent and its role in biodiversity conservation. The APVMA’s Preliminary Review Findings and associated Technical Report were released for public comment in May 2005. This Technical Report has been updated to correct errors that were identified in the draft, including in the draft conclusions. New research and argument that have occurred since the report was first drafted are presented in section 9 of this report. Many of the changes to the report’s conclusions and recommendations are based on the information presented therein.
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