EPA STAFF EVALUATION AND REVIEW REPORT Application for the modified reassessment of Callisto (Marketed under Tenacity) APP202063 February 2016 www.epa.govt.nz 2 Application for the modified reassessment of Callisto (APP202063) Overview Application Code APP202063 Application Type To modify an existing approval for a hazardous substance under Section 63A of the Hazardous Substances and New Organisms Act 1996 (“the Act”) Application Sub-Type Modified reassessment – externally generated Applicant Syngenta Crop Protection Limited To extend the use of the registered product Callisto to turf, the Purpose of the application product is to be marketed under the name Tenacity Turf Herbicide Approvals to be amended HSR002475 – Callisto Date Application Received 13 April 2015 Submission Period 28 April 2015 – 10 June 2015 Submissions received Moreen Taylor Te Rūnanga o Ngāi Tahu (Ngāi Tahu) Bay of Plenty Regional Council Hearing date 1 March 2016 February 2016 3 Application for the modified reassessment of Callisto (APP202063) Table of Contents List of Tables ......................................................................................................................................... 4 1. Background ................................................................................................................................. 6 2. Process, consultation and notification ..................................................................................... 6 3. Control to be reassessed ........................................................................................................... 7 4. Submissions ................................................................................................................................ 7 5. Staff response to the submissions ........................................................................................... 8 6. Risk and benefit assessment .................................................................................................... 8 Assessment of risks to human health and the environment ......................................................... 9 Overall assessment of the risk and the benefits ......................................................................... 13 7. Controls ..................................................................................................................................... 13 Proposed amendment................................................................................................................. 14 Additional controls and variation of controls to manage risk associated with the new use ........ 14 8. Overall evaluation and recommendation ............................................................................... 15 Appendix A: Proposed New Controls ............................................................................................... 17 Appendix B: Mammalian toxicology ................................................................................................. 23 Appendix C: Ecotoxicology ............................................................................................................... 29 Appendix D: Quantitative human health risk assessment ............................................................. 43 Worker risk assessment.............................................................................................................. 46 Bystander risk assessment ......................................................................................................... 48 Summary and conclusions of the human health risk assessment .............................................. 49 Appendix E: Quantitative ecological risk assessment ................................................................... 50 Environmental fate data .............................................................................................................. 50 Summary of ecotoxicological data on mesotrione and its metabolites ....................................... 54 Aquatic risk assessment ............................................................................................................. 61 Terrestrial risk assessment ......................................................................................................... 67 Summary and conclusions of the ecological risk assessment ................................................... 79 February 2016 4 Application for the modified reassessment of Callisto (APP202063) List of Tables Table 1: Hazard classification for Callisto ............................................................................................... 8 Table 2: Proposed new controls for Callisto ......................................................................................... 17 Table 3: Phototoxicity studies ............................................................................................................... 23 Table 4: Immunotoxicity studies ............................................................................................................ 24 Table 5: Endocrine disrupting properties .............................................................................................. 26 Table 6: Aquatic plants acute toxicity (Freshwater species) - effects of the metabolite R44276 (AMBA) .............................................................................................................................................................. 29 Table 7: Aquatic plants acute toxicity (Freshwater species) – effects of the metabolite R169649 (MNBA) .................................................................................................................................................. 31 Table 8: Aquatic plants acute toxicity (Freshwater species) – effects of the metabolite SYN546974 .. 33 Table 9: Terrestrial plants bioassay – effects of ZA1296 (mesotrione) and metabolites AMBA and MNBA .................................................................................................................................................... 35 Table 10: Terrestrial plants – semi field studies.................................................................................... 37 Table 11: Transferable turf residues ..................................................................................................... 43 Table 12: existing AOEL for mesotrione ............................................................................................... 46 Table 13: The derivation of dermal absorption value in humans .......................................................... 46 Table 14: Output of human worker (operator) mixing, loading and application exposure modelling.... 47 Table 15: Re-entry exposure modelling ................................................................................................ 48 Table 16: Exposure scenario ................................................................................................................ 49 Table 17: Estimated exposure of 15 kg toddler .................................................................................... 49 Table 18: Summary of environmental fate data on mesotrione and its metabolites – Values in bold are used for the risk assessment ................................................................................................................ 50 Table 19: Summary of ecotoxicological data on mesotrione and its metabolites – Values in bold are used for the risk assessment ................................................................................................................ 54 Table 20: Reference documents for environmental exposure and risk assessments .......................... 58 Table 21: Level of concern .................................................................................................................... 62 Table 22: The parameters used in GENEEC2 modelling ..................................................................... 62 Table 23: Acute risk quotients derived from the GENEEC2 model and toxicity data ........................... 64 Table 24 Chronic risk quotients derived from the GENEEC2 model and toxicity data ......................... 65 Table 25: Input parameters for Sci-Grow analysis and resulting PEC values ...................................... 66 Table 26: Levels of concern .................................................................................................................. 67 Table 27: Acute in-field TER value for earthworms .............................................................................. 69 Table 28: Acute off-field TER value for earthworms ............................................................................. 69 Table 29: Basic drift values for 2 applications....................................................................................... 69 Table 30: RQ value for non-target plant ................................................................................................ 70 Table 31: Exposure of birds for acute screening assessment .............................................................. 72 Table 32: Exposure of birds for reproduction screening assessment ................................................... 73 Table 33: Measures of exposure and toxicity used in the reproduction assessment ........................... 73 February 2016 5 Application for the modified reassessment of Callisto (APP202063) Table 34: TER values for acute dietary and reproductive risk assessment – Screening assessment