Application for the Reassessment of a Hazardous Substance under Section 63 of the Hazardous Substances and New Organisms Act 1996




НазваниеApplication for the Reassessment of a Hazardous Substance under Section 63 of the Hazardous Substances and New Organisms Act 1996
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Application for the Reassessment of a Hazardous Substance under Section 63 of the Hazardous Substances and New Organisms Act 1996


Azinphos methyl and
Formulations containing Azinphos methyl



Application Number: HRC07002


Applicant:

Chief Executive ERMA New Zealand


February 2009


Signed:_________________ Date:­­­__________


Contents

Executive Summary 10

Submissions 16

Section One – The Application 17

1.1Applicant details 17

1.2Background to the application 17

1.3Preparation of the application 18

1.4Consideration of scenarios 19

1.5Notification and consultation 20

1.6Substance(s) covered by the application 20

Section Two – The Risk Management Context 21

2.1Risk management context 21

2.2Identification and assessment process 22

2.3Consideration of uncertainty 22

2.4Ethical considerations 22

2.5Principles of the Treaty of Waitangi (Te Tiriti ō Waitangi) 24

Section Three – The Substance and its Lifecycle 25

3.1Identification of the substance(s) 25

3.2Regulatory History in New Zealand 25

3.3Mode of action 26

3.4Review of hazardous properties 26

3.5Classification 26

3.6Lifecycle 28

3.7Existing Controls 31

Section Four – Identification and Assessment of Adverse and Beneficial Effects (Risks, Costs and Benefits) 32

4.1Introduction 32

4.2Incidents 32

4.3Environment 33

4.4Environment 33

4.5Human health and safety 35

4.6Society and the market economy 36

4.7Māori interests and concerns 41

4.8International obligations 42

Section Five – Likely Effects of azinphos methyl Being Unavailable 44

5.1Availability of alternative insecticides 44

5.2Comparative hazard assessment of alternatives 47

5.3Comparative cost of alternative products 55

Section Six – Proposals to Manage Risks 56

6.1Evaluation of risk management options 56

Section Seven – Overall Evaluation and recommendations 61

7.2Proposed additions and modifications to controls under section 77A 63

Appendix A: Report on azinphos methyl use in New Zealand 64

Appendix B: Chemical and physical properties of azinphos methyl 147

Appendix C: Environmental Fate of azinphos methyl 150

Appendix D: Environmental Exposure modelling azinphos methyl 155

Appendix E: Ecotoxicity of azinphos methyl 167

Aquatic toxicity 167

Toxicity to birds 173

Toxicity to soil organisms 174

Toxicity to non-target invertebrates 174

Environmental classification 181

Appendix F: Risk Assessment: Environment azinphos methyl 183

Appendix G: Review of toxicology and setting of an AOEL 195

Appendix H: Human Health Risk Assessment Azinphos methyl 265

Appendix I: Derivation of formulation classifications 330

Appendix J: Qualitative Descriptors for Risk/Benefit Assessment 331

Assessing risks, costs and benefits qualitatively 331

Appendix K: Current Controls 336

HSNO Act controls 336

Appendix L: Overseas Regulatory Action 345

Australia 351

Appendix M: Parties consulted during the preparation of this application 355

Appendix N: ACVM and other NZFSA administered legislation 359

370

Appendix O: References 371


List of Tables


Table 1: Summary of risks and proposed controls 14

Table 2: Substances covered by this application 20

Table 3: Identity of azinphos methyl 25

Table 4: Classification of azinphos methyl formulations and its formulations 27

Table 5: Description of manufacture, importation, transport and storage of Cotnion 200 Insecticide 28

Table 6: Use pattern 29

Table 7: Summary of current uses of Cotnion 200 Insecticide 30

Table 8: Scenarios evaluated in the risk modelling 30

Table 9: Identification of potential sources of risk 32

Table 10: Identification of adverse effects on society and the economy 37

Table 11: Identification of beneficial effects on society and the economy 38

Table 12: Alternative products 47

Table 13: Comparative hazard profile of alternative insecticides 51

Table 14: Risks and proposed risk management measures 59

Table B1: Physico-chemical properties of the active ingredient 147

Table B2: Physico-chemical properties of Azinphos methyl formulations 149

Table C1: Terrestrial fate and behaviour of azinphos methyl 150

Table C2: Aquatic fate and behaviour of azinphos methyl 153

Table C3: Bioconcentration of azinphos methyl 154

Table D1: Input parameters for GENEEC2 analysis 155

Table D2: Scenarios used in exposure modelling and aquatic estimated environmental concentrations 156

Table D3: Output from GENEEC2 exposure modelling 157

Table D4: Daily dietary dose for screening step, acute toxicity 161

Table D5: Daily dietary dose for first tier assessment acute toxicity 162

Table D6: Daily dietary dose for screening step, chronic toxicity 163

Table D7: Deposition azinphos methyl off-field 164

Table D8: Soil concentration of azinphos methyl 165

Table D9: Terrestrial invertebrates- in-field exposure 165

Table D10: Terrestrial invertebrates- off field exposure 166

Table E1: Effect concentrations 168

Table E2: Aquatic Toxicity 170

Table E3: Terrestrial vertebrate toxicity 173

Table E4: Toxicity to soil organisms 174

Table E5: Toxicity to honeybees 175

Table E6: Environmental Classification of azinphos methyl 182

Table F1: Levels of concern in environmental risk assessment for aquatic organisms 183

Table F2: Levels of concern in environmental risk assessment for terrestrial organisms 184

Table F3: Environmental risk quotients for aquatic organsims 185

Table F4: Acute avian risk assessment – screening step 187

Table F5: Acute avian risk assessment – first tier assessment 188

Table F6: Chronic avian risk assessment – screening step 190

Table F7: Earthworm –TER off-field 191

Table F8: Earthworm –TER in-field 191

Table F9: Terrestrial invertebrates - in-field 192

Table F10: Terrestrial invertebrates – off-field 193

Table G1: CLASS 6 & 8 Toxicological Hazard Classifications: 196

Table G2: Key Studies for AOEL benchmark: 198

Table G3: APVMA reported in vivo studies 216

Table G4: APVMA reported in vitro studies 217

Table G5: Comparison of critical NOAEL/LOAEL used for occupational exposure health benchmarks (mg/kg b.w./day) 257

Table G6: Dermal absorption data 259

Table G7: CLASS 6 & 8 Toxicological Hazard Classifications 260

Table G8: Key Studies for AOEL benchmark 262

Table H1: Azinphos methyl uses and application rates 266

Table H2: Activity Scenarios 275

Table H3: Occupational Exposure Estimates & Risk Assessment 276

Table H4: Occupational Exposure Estimates & Risk Assessment 277

Table H5: Transfer Coefficients 282

Table H6: Re-Entry Worker Exposure Estimates & Risk Assessment Default Model with No PPE a 284

Table H7: Re-Entry Worker Exposure Estimates & Risk Assessment with PPE – gloves, coverall and sturdy footwear a 285

Table H8: Bystander Exposure Estimates and Risk Assessment 293

Table H9: Azinphos methyl uses and application rates 295

Table H10: Occupational Exposure Estimates & Risk Assessment with Engineering Controls 320

Table H11: Proposed application rates vis-à-vis PPE and RPE recommendations
(kg a.i./ha per year) 326


Table J1: Magnitude of adverse effect (risks and costs) 332

Table J2: Magnitude of beneficial effect (benefits) 333

Table J3: Likelihood 334

Table J4: Level of risk 334

Table J5: Assignment of level of risk/benefit 335

Table K1: Existing controls for azinphos methyl and its formulations 336

Table K2: Summary of default controls applicable to azinphos methyl 338

Table K3: Agricultural Compounds and Veterinary Medicines Group conditions for azinphos methyl formulations 343

Table L1: USEPA, azinphos methyl phase-out schedule 346

Table L2: Mitigation measures during phase-out of azinphos methyl use on cherries 346

Table L3: PMRA, azinphos methyl phase-out schedule 347

Table L4: PMRA Mitigation Measures Relevant to New Zealand: Measures pertaining to occupational and environmental risks 348

Table L5: Proposed Variations to Product Registrations and Labels 352



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