Application for Reassessment of a Hazardous Substance under section 63 of the Hazardous Substances and New Organisms Act 1996 Name of substance: endosulfan and formulations containing endosulfan Applicant: Chief Executive ERMA New Zealand Office use only Application Code: Date received:____/____/_ ERMA New Zealand Contact: Initial Fees Paid: $ Application Version No: Contents Executive Summary .......................................................................................................... 8 The application ...................................................................................................................... 8 Precautionary approach to determining risks ......................................................................... 8 Current use of endosulfan ...................................................................................................... 8 Overseas regulatory status of endosulfan ............................................................................... 9 Risks, costs and benefits of use in New Zealand ................................................................. 10 Preliminary recommendations ............................................................................................. 13 Submissions ......................................................................................................................... 15 Section One – Applicant Details .................................................................................... 16 Section Two – Application Type and Related Approvals .............................................. 17 2.1 Application type ..................................................................................................... 17 2.2 Sources of information for this application and consideration of uncertainty ........ 18 Section Three – Information on the Substances ............................................................. 20 3.1 Identification of the substances .............................................................................. 20 3.2 Chemical and physical properties of endosulfan and its formulations ................... 22 3.3 Review of hazardous properties of endosulfan and endosulfan formulations ........ 24 3.4 Lifecycle of endosulfan formulations ..................................................................... 27 3.5 Manufacture ............................................................................................................ 27 Importation........................................................................................................................... 27 Repackaging/storage ............................................................................................................ 27 Transport .............................................................................................................................. 27 Disposal ............................................................................................................................... 28 Use of endosulfan ................................................................................................................ 28 3.6 Existing controls for endosulfan and endosulfan formulations .............................. 37 3.7 Controls applied under the HSNO Act ................................................................... 37 3.8 Non-HSNO Act controls......................................................................................... 54 Agricultural Compounds and Veterinary Medicines Act 1997 ............................................ 54 Other requirements............................................................................................................... 55 Section Four – Risks, Costs and Benefits ....................................................................... 56 4.1 Identification of the potential risks, costs and benefits of the substances .............. 56 Risk management context .................................................................................................... 56 4.2 Risks and costs to human health and the environment ........................................... 58 Reports of adverse effects of endosulfan formulations ........................................................ 59 Endosulfan Reassessment – Application June 2008 Page 3 of 244 Identification of benefits (positive effects) .......................................................................... 63 4.3 Assessment of potentially significant risks, costs and benefits .............................. 70 Assessment of environmental risks ...................................................................................... 70 Assessment of human health risks ....................................................................................... 96 Assessment of benefits (positive effects) ........................................................................... 136 4.4 Relationship of Māori to the environment ............................................................ 142 Adverse effects .................................................................................................................. 142 Mauri .................................................................................................................................. 142 Kaitiakitanga ...................................................................................................................... 143 Hauora ................................................................................................................................ 143 Assessment......................................................................................................................... 143 Treaty of Waitangi ............................................................................................................. 143 Section Five – International Considerations ................................................................. 145 Section Six – Likely Effects of the Substance Being Unavailable ............................... 146 Section Seven – Overall Evaluation and Recommendations ........................................ 148 7.1 Overall evaluation ................................................................................................. 148 7.2 Preliminary recommendations .............................................................................. 149 Section Eight – Summary of Public Information ......................................................... 151 8.1 Names of the substances for the public register ................................................... 151 8.2 Purpose of the application for the public register ................................................. 151 8.3 Use categories of the substances ........................................................................... 151 References .................................................................................................................... 152 Appendices ................................................................................................................... 160 Appendix A – Human health hazard profile ................................................................. 161 Introduction ..................................................................................................................... 161 Pharmacokinetics ............................................................................................................ 161 6.1 classification – Acute toxicity ................................................................................... 161 6.3, 6.4 & 6.5 classification – Irritancy/sensitisation ...................................................... 162 6.6 classification – Mutagenicity/genotoxicity ............................................................... 163 6.7 classification – carcinogenicity ................................................................................. 166 6.8 classification – Reproductive/developmental toxicity .............................................. 166 6.9 classification – Target organ toxicity ........................................................................ 168 Endocrine disruption ....................................................................................................... 171 Page 4 of 244 June 2008 Endosulfan Reassessment – Application Endosulfan sulphate ........................................................................................................ 174 Endosulfan residue burdens ............................................................................................ 175 Appendix B – Environmental hazard profile ................................................................ 176 Aquatic Toxicity ............................................................................................................. 176 Non-target invertebrate toxicity ...................................................................................... 186 Appendix C – Monitoring studies examined by the Agency........................................ 189 Appendix D – Tier II modelling of aquatic risks.......................................................... 192 Appendix E – Input and results of analysis used to select worst-case sites in Ramanarayanan et al (1999) ......................................................................................... 199 Appendix F – Calculations underlying bird risk assessments ...................................... 201 Appendix G – Margins of exposure for re-entry to