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On the Evaluation of the New Active Aureobasidium Pullulans (Strains DSM 14940 and DSM 14941) in the Product Botector Fungicide

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On the Evaluation of the New Active Aureobasidium Pullulans (Strains DSM 14940 and DSM 14941) in the Product Botector Fungicide PUBLIC RELEASE SUMMARY on the evaluation of the new active Aureobasidium pullulans (strains DSM 14940 and DSM 14941) in the product Botector Fungicide AUGUST 2017 © Australian Pesticides and Veterinary Medicines Authority 2017 ISSN: 1443-1335 (electronic) ISBN: 978-1-925390-85-8 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 (s ee 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 vii 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 3 2.1 Active constituent 3 2.2 Formulated product 5 2.3 Recommendations 5 3 TOXICOLOGICAL ASSESSMENT 6 3.1 Evaluation of toxicology 6 3.2 Public Health Standards 7 4 RESIDUES ASSESSMENT 8 4.1 Metabolism 8 4.2 Residues in food and animal feeds 8 4.3 Residues in animal commodities 8 4.4 Dietary risk assessment 8 4.5 Recommendations 8 5 ASSESSMENT OF OVERSEAS TRADE ASPECTS OF RESIDUES IN FOOD 10 6 OCCUPATIONAL HEALTH AND SAFETY ASSESSMENT 11 6.1 Use pattern 11 6.2 Occupational exposure 11 6.3 Public exposure 11 6.4 Recommendations for safe use 11 6.5 Conclusions 12 7 ENVIRONMENTAL ASSESSMENT 13 7.1 Introduction 13 7.2 Environment Fate and Behaviour 13 iv PUBLIC RELEASE SUMMARY – BOTECTOR FUNGICIDE 7.3 Environmental Effects 13 7.4 Risk Assessment 15 7.5 Conclusions 15 8 EFFICACY AND SAFETY ASSESSMENT 16 8.1 Proposed product use pattern 16 8.2 Summary of evaluation of efficacy and crop safety 16 8.3 Conclusions 17 9 LABELLING REQUIREMENTS 18 ABBREVIATIONS 21 GLOSSARY 24 REFERENCES 25 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 Environment and State Departments of Primary Industries. The APVMA has a policy of encouraging transparency in its activities and 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 on the APVMA website. 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 to encourage public comment. About this document This is a Public Release Summary. It indicates that the 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—BOTECTOR FUNGICIDE Making a submission 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 approval of the new active constituents and registration of Botector Fungicide should be granted. Submissions should relate only to matters that the APVMA is required, by legislation, to take into account in deciding whether to grant the application. These matters include aspects of public health, occupational health and safety, chemistry and manufacture, residues in food, environmental safety, trade, and efficacy and target crop or animal safety. Submissions should state the grounds on which they are based. Comments received that address issues outside the relevant matters cannot be considered by the APVMA. Submissions must be received by the APVMA by close of business on 19 September 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] 1 A full definition of "confidential commercial information" is contained in the Agvet Code. PREFACE vii Further information Further information can be obtained via the contact details provided above. Further information on Public Release Summaries can be found on the APVMA website: http://www.apvma.gov.au. INTRODUCTION 1 1 INTRODUCTION 1.1 Applicant Nufarm Australia Limited. 1.2 Purpose of application Nufarm Australia Limited has applied to the APVMA for registration of the new product Botector Fungicide containing 5 x 109 CFU/g (1.000 g/kg) of the new active constituent Aureobasidium pullulans (strains DSM 14940 and DSM 14941) as a wettable powder formulation. This publication provides a summary of the information reviewed and an outline of the regulatory considerations for the proposed registration of Botector Fungicide, and approval of the new active constituent, Aureobasidium pullulans (strains DSM 14940 and DSM 14941). 1.3 Product claims and use pattern Botector Fungicide is a biological fungicide intended for use as a preventative treatment in the control of botrytis bunch rot / grey mould (Botrytis cinerea) in grapes. It is applied at a rate of 100 g/100 L as a foliar spray into the bunch zone or the whole canopy from phenological stage EL25 (80% capfall / flower hoods fallen) to EL 37 (ripening). The use of Botector Fungicide will be restricted to ground application, applied as a medium spray. Application can either be by dilute or concentrate spraying, in a minimum spray volume of 400 L/ha. Up to 4 applications can be applied per season, as part of a botrytis bunch rot program. A withholding period is not required when used as directed. 1.4 Mode of action The mode of action of Aureobasidium pullulans against Botrytis cinerea on grapes occurs through active competition for space and nutrients thereby excluding plant pathogens from infection. Aureobasidium pullulans is an antagonistic organism belonging to the class of Eu-ascomycetes and has no known sexual cycle. These microorganisms occur naturally in the environment. Internationally, the Fungicide Resistance Action Committee (FRAC) has classified Botector Fungicide as “Not Classified”. Due to the mode of action of Aureobasidium pullulans (competition in nutrition and space) there is no potential for traditional fungicide resistance development. 1.5 Overseas registrations Botector Fungicide is at present registered for the control of Botrytis cinerea in grapevines in USA, Morocco, Switzerland, Canada (suppression), Germany and Spain.
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