ERMA New Zealand Evaluation and Review Report Application for approval to import or manufacture ParaMite Selective Miticide for release Application Number: ERMA200695 Executive Summary Background information Sumitomo Chemical Australia Pty Ltd is seeking approval to import or manufacture ParaMite Selective Miticide for release. ParaMite Selective Miticide is a soluble concentrate containing 110 g/litre etoxazole and other ingredients. ParaMite Selective Miticide is intended for the control of Six-Spotted Mites in avocados. ParaMite Selective Miticide will be applied by ground-based methods only, at a maximum application rate of 1.05 L/ha (121.6 g ai/ha), 1 time per year. Etoxazole is a new active ingredient to New Zealand. Classification The Agency has classified ParaMite Selective Miticide based on the composition of ParaMite Selective Miticide and the effects of its components. Hazardous Property Assessment Target Organ Toxicity 6.9A Aquatic Ecotoxicity 9.1A Risk Assessment The Agency‘s assessment of the risks posed by ParaMite Selective Miticide to the environment and to human health, during the substance‘s lifecycle, is based on qualitative assessment and quantitative modelling using the GENEEC2 and German BBA models. The Agency considers that the risk assessments indicate that the risks to human health and the environment posed by ParaMite Selective Miticide are negligible with the proposed controls in place. The Agency has evaluated information supplied by the applicant about the benefits of ParaMite Selective Miticide and considers that benefits are likely to be realised through the release of this substance. ERMA New Zealand Evaluation and Review Report: Application ERMA200695 Page 2 of 125 Controls The Agency has proposed that the default controls for ParaMite Selective Miticide be modified such that: - no Tolerable Exposure Limits (T1), Workplace Exposure Standards (T2) or Environmental Exposure Limits (E1) are set at the present time and any default values are deleted; - Acceptable Daily Exposure (ADE) and Potential Daily Exposure (PDE) values are set for etoxazole; - the maximum application rate for ParaMite Selective Miticide shall be 1.05 L/ha (121.6 g ai/ha), with a maximum application frequency of 1 application per year; - further controls regarding stationary containment systems are added; - a control which prohibits application of ParaMite Selective Miticide onto or into water is added; and - a control which restricts the application of ParaMite Selective Miticide to ground-based application methods only is added. The Agency considers that it is appropriate for certain other variations to be made to the default controls. These variations are discussed in Section 4 of this E&R Report and further in Appendix 3. Conclusion The Agency considers that there are negligible risks to human health and to the environment with the proposed controls in place and potentially significant benefits associated with the release of ParaMite Selective Miticide. Therefore, the Agency considers that it is evident that the benefits of releasing ParaMite Selective Miticide outweigh the costs and the application may be approved in accordance with clause 26. ERMA New Zealand Evaluation and Review Report: Application ERMA200695 Page 3 of 125 Table of Contents 1. The Application .......................................................................................................... 5 2. The substance, its lifecycle and its hazardous properties ........................................... 6 3. Identification and assessment of risks, costs and benefits .......................................... 8 4. Setting controls ......................................................................................................... 11 5. Overall evaluation and recommendation .................................................................. 14 Appendix 1: Classification of ParaMite Selective Miticide .......................................... 15 Appendix 2: Risk Assessment ....................................................................................... 73 Appendix 3: Default controls for ParaMite Selective Miticide. ................................. 100 Appendix 4: Proposed controls for ParaMite Selective Miticide ................................ 105 Appendix 5: Parties notified ........................................................................................ 110 Appendix 6: References .............................................................................................. 112 Appendix 7: Confidential material .............................................................................. 113 Supplementary Information ............................................................................................. 114 1. Regulatory basis for assessing the application ....................................................... 114 2. Legislation that will affect the use of hazardous substances within New Zealand 115 3. Risk assessment ...................................................................................................... 119 4. Qualitative descriptors for risk/benefit assessment ................................................ 121 5. Decision Path .......................................................................................................... 125 ERMA New Zealand Evaluation and Review Report: Application ERMA200695 Page 4 of 125 1. The Application 1.1. The application details are summarised in Table 1. Table 1 Details of the application Application Code ERMA200695 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‖) Application Sub-Type Notified - Category C Applicant Sumitomo Chemical Australia Pty Ltd Date Application Received 2 December 2010 Submission Period 13 December 2010 – 18 February 2011 Consideration Further information was requested from the applicant during the evaluation and review of the application in accordance with section 58 and consequently the consideration was postponed for 5 working days. Due to additional delays in the perparation of this E&R Report the Authority has delayed the consideration of this application until xxxxxxx. Purpose of the Application To import or manufacture ParaMite Selective Miticide (110g/kg etoxazole) for control of Six- Spotted Mite (Eotetranychus sexmaculatus) in avocados. Parties Notified On 13 December 2010 the following were notified the Minister for the Environment, the Department of Labour and the New Zealand Food Safety Authority (ACVM Group); interested parties listed in Appendix 5; and the public1. Submissions received One submission was received. The submitter did not request to be heard in support of their submission. ERMA staff involved in Haydn Murdoch – Advisor (Hazardous Substances) the assessment Johanna Prankerd – Advisor (Hazardous Substances) Apostolos Koutsaftis – Advisor (Hazardous Substances) Rhian Cope – Senior advisor (Hazardous Substances) Patrick Gemmell – Programme Manager (Kaupapa Kura Taiao). ERMA staff members Jim Waters – Senior Advisor (Hazardous Substances) responsible for review Noel McCardle – Programme Manager (Hazardous 1 The application was advertised in the Dominion Post, the New Zealand Herald, The Christchurch Press and the Otago Daily times and placed on the ERMA New Zealand website. ERMA New Zealand Evaluation and Review Report: Application ERMA200695 Page 5 of 125 Substances) Information assessed The application Confidential appendices 1.2. This report should be read in conjunction with the attached Supplementary Information which contains information on: The legislative criteria. Approach to risk assessment. Decision pathway used in the decision process. 1.3. The Agency considers that it accessed sufficient information to undertake a full assessment of the substance from a scientific and technical perspective and that there are no other significant uncertainties that need to be considered by the Authority. 2. The substance, its lifecycle and its hazardous properties The substance and its lifecycle 2.1. ParaMite Selective Miticide is a soluble concentrate containing 110 g/litre etoxazole and other ingredients. ParaMite Selective Miticide is intended for the control of Six-Spotted Mites in avocados. 2.2. The applicant has provided the following details about the lifecycle of ParaMite Selective Miticide. 2.2.1. Importation/Manufacture and Packaging. ParaMite Selective Miticide will be imported fully formulated, packed and labelled. The product will be shipped stacked and secured on pallets. Import will be once a year. The possibility exists for re-labelling the imported containers. The substance may be imported in bulk 200 L drums and decanted into 5 L containers and labelled after re-packaging. 2.2.2. ParaMite Selective Miticide will be packaged in 5 L HDPE containers with a plastic screw top. The label will be attached with glue. 2.2.3. Transport. Transportation of ParaMite Selective Miticide will conform to domestic requirements for transportation and will occur by road, rail and sea. 2.2.4. Storage. ParaMite Selective Miticide will be stored on arrival at Gro- Chem Agrinova premises. These premises will have storage areas in the warehouse that have prominent signage to denote the substances being held. Product will be dispatched to retail outlets to be stored on shelves for sale to the commercial end user. ERMA New Zealand Evaluation and Review Report: Application ERMA200695 Page 6 of 125 2.2.5. Use. ParaMite