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Public Release Summary PUBLIC RELEASE SUMMARY on the evaluation of the new active bicyclopyrone in the product Talinor Herbicide APVMA Product Number [P82256] APRIL 2017 © Australian Pesticides and Veterinary Medicines Authority 2017 ISSN: 1443–1335 (electronic) ISBN: 978-1-925390-68-1 (electronic) Ownership of intellectual property rights in this publication Unless otherwise noted, copyright (and any other intellectual property rights, if any) in this publication is owned by the Australian Pesticides and Veterinary Medicines Authority (APVMA). Creative Commons licence With the exception of the Coat of Arms and other elements specifically identified, this publication is licensed under a Creative Commons Attribution 3.0 Australia Licence. This is a standard form agreement that allows you to copy, distribute, transmit and adapt this publication provided that you attribute the work. A summary of the licence terms is available from www.creativecommons.org/licenses/by/3.0/au/deed.en. The full licence terms are available from www.creativecommons.org/licenses/by/3.0/au/legalcode. The APVMA’s preference is that you attribute this publication (and any approved material sourced from it) using the following wording: Source: Licensed from the Australian Pesticides and Veterinary Medicines Authority (APVMA) under a Creative Commons Attribution 3.0 Australia Licence. In referencing this document the Australian Pesticides and Veterinary Medicines Authority should be cited as the author, publisher and copyright owner. Use of the Coat of Arms The terms under which the Coat of Arms can be used are set out on the Department of the Prime Minister and Cabinet website (see www.dpmc.gov.au/pmc/publication/commonwealth-coat-arms-information-and-guidelines). Disclaimer The material in or linking from this report may contain the views or recommendations of third parties. Third party material does not necessarily reflect the views of the APVMA, or indicate a commitment to a particular course of action. There may be links in this document that will transfer you to external websites. The APVMA does not have responsibility for these websites, nor does linking to or from this document constitute any form of endorsement. The APVMA is not responsible for any errors, omissions or matters of interpretation in any third-party information contained within this document. Comments and enquiries regarding copyright: Director Public Affairs and Communication Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Australia Telephone: +61 2 6210 4988 Email: [email protected] This publication is available from the APVMA website: www.apvma.gov.au. CONTENTS iii CONTENTS PREFACE V About this document v Making a submission vi Further information vi 1 INTRODUCTION 1 1.1 Applicant 1 1.2 Purpose of application 1 1.3 Product claims and use pattern 1 1.4 Mode of action 1 1.5 Overseas registrations 1 2 CHEMISTRY AND MANUFACTURE 2 2.1 Active constituent 2 2.2 Formulated product 4 2.3 Recommendations 5 3 TOXICOLOGICAL ASSESSMENT 6 3.1 Evaluation of toxicology 6 3.2 Public health standards 13 4 RESIDUES ASSESSMENT 15 4.1 Introduction 15 4.2 Metabolism 16 4.3 Analytical methods 17 4.4 Stability of the pesticides in stored analytical samples 17 4.5 Residue definition 18 4.6 Residue trials 18 4.7 Rotational crops 19 4.8 Animal commodity MRLs 19 4.9 Estimated dietary intake 21 4.10 Bioaccumulation potential 22 4.11 Recommendations 22 5 ASSESSMENT OF OVERSEAS TRADE ASPECTS OF RESIDUES IN FOOD 24 5.1 Commodities exported 24 5.2 Destination of exports 24 5.3 Proposed Australian use-pattern 24 5.4 Overseas registration and approved label instructions 25 iv PUBLIC RELEASE SUMMARY—TALINOR HERBICIDE 5.5 Comparison of Australian MRLs with Codex and International MRLs 25 5.6 Potential risk to trade 26 6 OCCUPATIONAL HEALTH AND SAFETY ASSESSMENT 27 6.1 Formulation, packaging, transport, storage and retailing 27 6.2 Use pattern 27 6.3 Exposure during use 27 6.4 Exposure during re-entry 28 6.5 Recommendations for safe use 28 6.6 Conclusion 28 7 ENVIRONMENTAL ASSESSMENT 29 7.1 Environmental fate and behaviour 29 7.2 Environmental effects 31 7.3 Risk assessment 33 7.4 Conclusion 34 8 EFFICACY AND SAFETY ASSESSMENT 35 8.1 Proposed product use pattern 35 8.2 Assessment of study/trial data 35 8.3 Conclusions 37 9 LABELLING REQUIREMENTS 38 ABBREVIATIONS 49 GLOSSARY 53 REFERENCES 54 LIST OF TABLES Table 1: Nomenclature of bicyclopyrone 2 Table 2: Physicochemical properties of bicyclopyrone 3 Table 3 Identification of the proposed product 4 Table 4: Physicochemical properties of Talinor Herbicide 5 PREFACE v PREFACE The Australian Pesticides and Veterinary Medicines Authority (APVMA) is the Australian Government regulator with responsibility for assessing and approving agricultural and veterinary chemical products prior to their sale and use in Australia. In undertaking this task, the APVMA works in close cooperation with advisory agencies, including the Department of Health and Ageing, Department of Environment and Energy, Department of Agriculture and Water Resources, and State Departments of Primary Industries. The APVMA has a policy of encouraging openness and transparency in its activities and of seeking community involvement in decision making. Part of that process is the publication of public release summaries for products containing new active constituents. The information and technical data required by the APVMA to assess the safety of new chemical products, and the methods of assessment, must be consistent with accepted scientific principles and processes. Details are outlined in the APVMA’s application requirements and data guidelines. This public release summary is intended as a brief overview of the assessment that has been conducted by the APVMA and of the specialist advice received from its advisory agencies. It has been deliberately presented in a manner that is likely to be informative to the widest possible audience thereby encouraging public comment. About this document This is a public release summary. It indicates that the Australian Pesticides and Veterinary Medicines Authority (APVMA) is considering an application for registration of an agricultural or veterinary chemical. It provides a summary of the APVMA’s assessment, which may include details of: • the toxicology of both the active constituent and product • the residues and trade assessment • occupational exposure aspects • environmental fate, toxicity, potential exposure and hazard • efficacy and target crop or animal safety. Comment is sought from interested stakeholders on the information contained within this document. vi PUBLIC RELEASE SUMMARY—TALINOR HERBICIDE Making a submission In accordance with section 13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether Talinor Herbicide should be registered. Submissions should relate only to matters that are required by the APVMA to be taken into consideration in determining whether the safety, efficacy or trade criteria have been met. Submissions should state the grounds on which they are based. Submissions must be received by the APVMA by close of business on 1 May 2017 and be directed to the contact listed below. All submissions to the APVMA will be acknowledged in writing via email or by post. Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered and in determining appropriate conditions of registration and product labelling. When making a submission please include: • contact name • company or group name (if relevant) • email or postal address (if available) • the date you made the submission. All personal information, and confidential information judged by the APVMA to be confidential commercial information (CCI)1 contained in submissions will be treated confidentially. Written submissions on the APVMA’s proposal to grant the application for registration that relate to the grounds for registration should be addressed in writing to: Case Management and Administration Unit Australian Pesticides and Veterinary Medicines Authority PO Box 6182 Kingston ACT 2604 Phone: +61 2 6210 4701 Fax: +61 2 6210 4721 Email: [email protected] Further information Further information can be obtained via the contact details provided above. Copies of full technical evaluation reports covering toxicology, occupational health and safety aspects, residues in food and environmental aspects are available from the APVMA on request. Further information on public release summaries can be found on the APVMA website: www.apvma.gov.au 1 A full definition of ‘confidential commercial information’ is contained in the Agvet Code. INTRODUCTION 1 1 INTRODUCTION 1.1 Applicant Syngenta Australia Pty Ltd 1.2 Purpose of application Syngenta Australia Pty Ltd has applied to the APVMA for registration of the new product Talinor Herbicide containing 175 g/L bromoxynil present as the octanoate, 37.5 g/L bicyclopyrone and 9.4 g/L cloquintocet- mexyl in an emulsifiable concentrate (EC) formulation. This publication provides a summary of the information reviewed and an outline of the regulatory considerations for the proposed registration of Talinor Herbicide, containing the new active constituent bicyclopyrone. Bromoxynil present as the octanoate (herbicide) and cloquintocet-mexyl (crop safener) are APVMA approved active constituents which are present in other APVMA registered products. Bicyclopyrone was assessed under a Global Joint Review (GJR) workshare arrangement where applications were submitted and considered concurrently in Australia, Canada and USA. The product Talinor Herbicide has been considered separately from the GJR workshare and is new to the Australian market. The active bicyclopyrone as well as the end-use product will be manufactured overseas and imported into Australia. 1.3 Product claims and use pattern Talinor Herbicide is a selective herbicide. The proposed use pattern is as a foliar spray applied in a tank mix with the registered Adigor Spray Adjuvant (60114) for the early post-emergent control and suppression of broadleaf weeds in wheat (except durum wheat) and barley (between wheat and barley crop stages GS12 and GS32).
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