Application for the Reassessment of a Group of Hazardous Substances Under Section 63 of the Hazardous Substances and New Organisms Act 1996 27 June 2013
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DECISION 7 August 2015 – a modified reassessment was undertaken. Please see APP202142. 21 July 2015 – amended under section 67A of the HSNO Act 2 July 2014 – amended under section 67A of the HSNO Act 27 June 2013 – original approval Application for the Reassessment of a Group of Hazardous Substances under Section 63 of the Hazardous Substances and New Organisms Act 1996 27 June 2013 APP201045: Active ingredients and/or formulated substances containing: Acephate, Benomyl, Carbaryl, Carbofuran, Carbosulfan, Chlorpyrifos, Chlorpyrifos-methyl, Diazinon, Dichlorvos, Dichlofenthion, Dimethoate, Ethion, Famphur, Fenamiphos, Fenitrothion, Isazofos, Maldison (Malathion), Methamidophos, Methomyl, Omethoate, Oxamyl, Phorate, Phoxim, Pirimicarb, Pirimiphos-methyl, Prothiofos, Pyrazophos and Terbufos www.epa.govt.nz Page 2 Decision on the Application for reassessment of OPC plant protection insecticides (APP201045) Chair’s introduction General – use and effects of organophosphates and carbamates in New Zealand Organophosphates and carbamates (OPCs) are insecticides that have been widely used in New Zealand and internationally for many decades against a broad range of insect pests for a variety of purposes (plant protection, veterinary medicine, public health and industrial uses). This reassessment relates to the use of OPCs for plant protection purposes. OPCs play a key role in New Zealand as part of our agricultural pest management programmes for the horticultural, grass/pastoral and ornamental sectors. OPCs are also used for biosecurity purposes to control and/or eliminate insects, pests and pathogens from live plant material entering New Zealand or being cleared at the border. OPCs affect the nervous system by inhibiting the enzyme acetylcholinesterase which leads to overstimulation of the nervous system. Of the two groups of substances organophosphates have a longer lasting effect on the nervous system than carbamates. OPCs are also harmful to the environment being very toxic to aquatic life and to terrestrial invertebrates, and in general they are also toxic to birds. This reassessment This reassessment has been extremely complex and time-consuming for all involved. It has taken several years to get to this point. The reassessment programme for OPCs started with reassessing acephate, diazinon, dichlorvos and methamidophos. However, the EPA decided that it was more appropriate, efficient and cost effective for all concerned to reassess the substances as a whole to ensure not only safe management of such substances but also to ensure that the suite of tools available for plant protection and biosecurity was not seriously undermined. The process Once the initial consultation phases had been completed the Committee held hearings in two locations (Wellington and Auckland) to hear from submitters. The Committee wishes to thank the submitters who have taken the time to make submissions both in writing and orally and the EPA staff for their technical and administrative assistance throughout the process. The outcome The Committee has made a decision which attempts to strike the appropriate balance between allowing the continued use of OPCs for commercial plant protection purposes whilst ensuring that the most serious effects are appropriately avoided or managed. In general the Committee has decided that OPC use in the home garden situation by unqualified users ought not to continue due to the health effects for users and visitors. For substances critical to the agricultural sectors, their use should be allowed to continue with additional controls imposed to ensure such uses are properly done to manage the risks to people’s health and the environment. June 2013 Page 3 Decision on the Application for reassessment of OPC plant protection insecticides (APP201045) Final comments As noted this has been a very complex and time-consuming task and the Committee is very mindful of the importance of this decision to all New Zealanders. There is a phase-in period for all the changes to allow time for a change in approach and practice to occur. The Committee has made a number of recommendations regarding this period and in relation to research and other matters that it will be asking the EPA to report back on over the coming years. Helen Atkins Chair, Organophosphate and carbamate plant protection insecticide reassessment committee of the Environmental Protection Authority 27 June 2013 June 2013 Page 4 Decision on the Application for reassessment of OPC plant protection insecticides (APP201045) Overview of the reassessment process Grounds Application – Grounds approved 26/10/12 Grounds must be established in order for an application for a reassessment to be lodged. An application for grounds is lodged with the EPA and is heard by an independent decision making committee established under HSNO. Reassessment Application – Notified for public consultation 02/11/12 – 22/01/13 Once grounds have been established, an application for a reassessment is lodged and notified for public consultation. Evaluation and Review Report – Circulated 18/02/13 After receipt of submissions on the application/consultation report, EPA Staff prepare an evaluation and review report taking into account information that has been submitted. This will be considered by the decision making committee. Public hearing – 04/03/13 and 07/03/13 Once EPA Staff have evaluated the submissions a public hearing is held, where submitters can speak to the decision making committee. Decision After a public hearing and consideration of the application, the decision making committee will issue its final decision. This is the Decision document. June 2013 Page 5 Decision on the Application for reassessment of OPC plant protection insecticides (APP201045) Table of Contents Chair’s introduction ............................................................................................................................... 2 Overview of the reassessment process .............................................................................................. 4 1. Summary of decision................................................................................................................... 6 2. Background ................................................................................................................................ 13 3. The Reassessment of OPC plant protection insecticides ..................................................... 16 4. Sequence of the consideration ................................................................................................ 27 5. Treaty of Waitangi (Tirito ō Waitangi) ...................................................................................... 28 6. The substances .......................................................................................................................... 30 7. Hazard classifications ............................................................................................................... 31 8. Acceptable Daily Intakes ........................................................................................................... 32 9. Current management regime .................................................................................................... 36 10. Key sectors for use of OPC plant protection insecticides .................................................... 38 11. Assessment of benefits ............................................................................................................ 41 12. Assessment of adverse effects ................................................................................................ 47 13. International obligations ........................................................................................................... 56 14. Revised management regime ................................................................................................... 57 15. Overall evaluation of significant adverse and positive effects ............................................. 72 16. Recommendations ..................................................................................................................... 78 17. Decision ...................................................................................................................................... 79 Appendix A: Substances considered in the reassessment ............................................................. 83 Appendix B: Classifications of the approvals under consideration ............................................... 89 Appendix C: Acceptable daily intake/Potential daily exposure for food values for OPC active ingredients ............................................................................................................................................ 98 Appendix D: Overview of risks and benefits for OPCs .................................................................... 99 Appendix E: Additional controls for plant protection insecticides containing OPCs ................ 120 Appendix F: Names of those who made oral presentations at the hearings ............................... 124 Appendix G: Decision path for the reassessment of OPC plant protection insecticides .......... 125 Appendix H: Abbreviations and acronyms ..................................................................................... 132 Annex: Controls for OPC plant protection insecticides ................................................................ 134 June 2013 Page 6 Decision on the Application for reassessment