EPA STAFF EVALUATION AND REVIEW REPORT Application for approval to import or manufacture Poncho Votivo for release APP202077 November 2015 www.epa.govt.nz 2 Application for approval to import Poncho Votivo for release (APP202077) 1. Overview Application Code APP202077 Application Type To import or manufacture for release any hazardous substance under Section 28 of the Hazardous Substances and New Organisms Act 1996 (“the Act”) Applicant Bayer New Zealand Limited To import Poncho Votivo, containing 502 g/L clothianidin and 102 Purpose of the application g/L Bacillus firmus, into New Zealand for use as a seed treatment in wheat, maize, forage brassicas and grass seed Date Application Received 1 October 2014 Submission Period 15 October 2014 – 27 November 2014 Submissions received Nineteen submissions were received; five indicated that they wished to be heard in person Information requests and Further information was requested under section 58 of the Act. time waivers Consequently, the start of consideration was waived under section 59 of the Act. Hearing Date 3 December 2015 November 2015 3 Application for approval to import Poncho Votivo for release (APP202077) 2. Introduction This report documents the assessment of this substance by the staff of the Environmental Protection Authority; it assesses the risks of the substance, proposes a set of controls to manage those risks and presents an overall recommendation to the Decision-making Committee. The purpose of this report is to inform the Decision-making Committee; this report is not a decision on the application. This application is for a seed treatment chemical, Poncho Votivo, which contains clothianidin, a neonicotinoid insecticide, and Bacillus firmus I-1582, a biopesticide, as the active ingredients. The non-active ingredients are confidential to the applicant and are not discussed in the public documents, but information regarding them is available to the Decision-making Committee. This application was publically notified and opened for submissions from the public because it contains a new pesticide active ingredient - Bacillus firmus I-1582. Several submitters have requested to be heard by the Decision-making Committee; consequently a hearing on this application will be held on 3 December 2015, in Wellington. November 2015 4 Application for approval to import Poncho Votivo for release (APP202077) Table of Contents 1. Overview ....................................................................................................................................... 2 2. Introduction .................................................................................................................................. 3 3. Application process .................................................................................................................... 7 4. Background and proposed use pattern of the substance ...................................................... 7 5. Hazard classification ................................................................................................................... 8 6. Risk assessment ......................................................................................................................... 9 Approach ....................................................................................................................................... 9 Overview ........................................................................................................................................ 9 Human health risks ...................................................................................................................... 10 Environmental risks ..................................................................................................................... 10 Cultural risk – the relationship of Māori to the environment ........................................................ 12 Risks to society and the community and the market economy ................................................... 13 7. Benefits assessment ................................................................................................................. 13 8. Summary of submissions and staff response ....................................................................... 14 9. Other matters to be considered ............................................................................................... 15 New Zealand’s international obligations ...................................................................................... 15 The effects of the substance being unavailable .......................................................................... 15 10. Conclusion ................................................................................................................................. 16 11. Recommendation ...................................................................................................................... 16 Appendix A: Proposed Controls for Poncho Votivo ........................................................................ 17 Justification for the proposed controls ............................................................................................. 24 Exposure limits ............................................................................................................................ 24 Variation and deletion of controls ................................................................................................ 24 Additional controls ....................................................................................................................... 25 Appendix B: Cultural risk assessment report .................................................................................. 28 Appendix C: Summary of submissions ............................................................................................. 32 Appendix D: Classification of Poncho Votivo .................................................................................. 37 Appendix E: Physical-chemical properties of the mixture .............................................................. 40 Appendix F: Robust study summaries for the mixture ................................................................... 42 Mammalian toxicity – Robust study summaries for the mixture .................................................. 42 Ecotoxicity – Robust study summaries for the mixture ............................................................... 49 November 2015 5 Application for approval to import Poncho Votivo for release (APP202077) Appendix G: Active ingredients and metabolites ............................................................................ 50 Identity of Bacillus firmus I-1582 ................................................................................................. 50 Mode of action ............................................................................................................................. 50 Production of secondary metabolites .......................................................................................... 50 Classification ............................................................................................................................... 51 Physico-chemical properties of the active ingredients ................................................................ 53 Appendix H: Robust study summaries for Bacillus firmus I-1582 ................................................. 56 Mammalian toxicity ...................................................................................................................... 56 Environmental fate....................................................................................................................... 71 Ecotoxicity ................................................................................................................................... 75 Appendix I: Robust study summaries for Clothianidin ................................................................... 98 Mammalian toxicity ...................................................................................................................... 98 Environmental fate..................................................................................................................... 113 Ecotoxicity ................................................................................................................................. 135 Residue levels ........................................................................................................................... 207 Appendix J: Human health risk assessment .................................................................................. 227 Qualitative risk assessment – Bacillus firmus B-1582 ............................................................... 227 Quantitative worker (operator) risk assessment – clothianidin ................................................. 227 Re-entry worker exposure assessment ..................................................................................... 234 Bystander risk assessment ....................................................................................................... 234 Summary and conclusions of the human health risk assessment ............................................ 234 Appendix K: Environmental risk assessment ................................................................................ 235 Summary of the data on the active ingredient and its metabolites