Application for the Reassessment of a Hazardous Substance under ...

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Table 22.there are no practicable risk reduction measures to protect birds or non-targetinvertebrates;exposure risks to children returning to treated locations.7.3.9 ERMA New Zealand has assessed exposures based on specific usage informationavailable to it during its evaluation. The details of recommendations based on thisusage information (such as application rates and methods, or PPE/RPE requirements)will reflect the criteria used to carry out the assessment.7.3.10 ERMA New Zealand considers that, if the proposed additional controls andrestrictions are accepted, a phase-in period of 12 months should also be adopted togive affected parties time to accommodate the revised conditions.7.3.11 ERMA New Zealand proposes that the classifications for dichlorvos and dichlorvoscontainingsubstances should be modified as detailed in Table 22.Summary of proposed hazard classifications for dichlorvos and dichlorvos-containingsubstances.Hazard ClassDichlorvosReady touse liquidcontaining4.4 g/ldichlorvos& 9.6 g/lpropoxurEmulsifiableconcentratecontaining1000 g/ldichlorvosAerosolcontaining50 g/kgdichlorvosEmulsifiableconcentratecontaining1140 g/ldichlorvosFlammableaerosolcontaining3.1 g/ldichlorvosand 8.7 g/lpropoxurDichlorvos reassessment – application Page 114 of 436DDVPinsecticidestripApproval # HSR002838 HSR000209 HSR000211 HSR000212 HSR000213 HSR000207 HSR000126 HSR001757Flammability No No No No 2.1.2A No No NoAcute toxicityN/A,N/A,6.1B 6.1D 6.1C6.1C(oral)aerosolaerosol6.1D 6.1CAcute toxicity(dermal)6.1B 6.1E 6.1B 6.1D 6.1B No 6.1E 6.1CAcute toxicity(inhalation)6.1B No 6.1B 6.1C 6.1C No 6.1C 6.1BSkinirritancy/corrosion6.3B 6.3B 6.3B No 6.3B 6.3B 6.3B 6.3BEyeirritancy/corrosion6.4A 8.3A 6.4A No 6.4A 6.4A 6.4A 6.4AContactsensitisation6.5B 6.5B 6.5B 6.5B 6.5B 6.5B 6.5B 6.5BMutagenicity 6.6B No 6.6B 6.6B 6.6B ND 6.6B 6.6BCarcinogenicity 6.7B 6.7B 6.7B 6.7B 6.7B 6.7B 6.7B 6.7BReproductive/developmentalNo No 6.8A No ND ND ND NotoxicityTarget organsystemic toxicity6.9A 6.9B 6.9A 6.9B 6.9A 6.9B 6.9A 6.9AAquaticecotoxicity9.1A 9.1A 9.1A 9.1A 9.1A 9.1A 9.1A 9.1ASoil ecotoxicity 9.2D No 9.2D No 9.2D ND ND NDTerrestrialvertebrate9.3A 9.3B 9.3A 9.3B 9.3A 9.3B 9.3B 9.3BecotoxicityTerrestrialinvertebrateecotoxicity9.4A 9.4B 9.4A 9.4A 9.4A 9.4B 9.4A 9.4AJ72.03
7.3.12 In preparing this application, ERMA New Zealand has not conducted a specificMāori consultation but the impression gained from hui with iwi/Māori resourcemanagers is that unless substances provide clear benefits to outweigh potential risk,they generally oppose the ongoing use of hazardous substances. In the absence offurther information regarding benefits, it is expected that submissions from Māoriwould seek the revocation of the approvals for dichlorvos and its formulations.7.3.13 Clauses 29 and 30 of the Methodology 8 provides that where there is scientific andtechnical uncertainty, the Authority must consider the materiality of the uncertaintyand if it cannot be resolved to its satisfaction, the Authority must take into accountthe need for caution in managing the adverse effects of the substance.7.3.14 Given the information currently before it and taking account of the need for caution,ERMA New Zealand makes the preliminary recommendations set out in Section 7.4.8Hazardous Substances and New Organisms (Methodology) Order 1998 (SR 1998/217).Dichlorvos reassessment – application Page 115 of 436
Page 1 and 2:
Application for the Reassessment of
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6.1 Evaluation of options to streng
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EXECUTIVE SUMMARYIn briefERMA New Z
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Aerosol containing 50 g/kgdichlorvo
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ERMA New Zealand‘s recommendation
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26 - 29Outdoor public space usage30
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Substance details1-8,11-16,20-25,30
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1.2.3 In 2008, the Environmental Ri
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Table 1. Dichlorvos-containing subs
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public environments and use for bio
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available to it. In preparing this
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3.3 International regulatory positi
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3.6 Classification3.6.1 The HSNO cl
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Hazard Class /SubclassClassificatio
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Hazard Class /SubclassClassificatio
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Rates:Fogging: 13 ml / litre (water
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BV2 SurfaceInsecticideBV2 SurfaceIn
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Table 7.Dichlorvos outdoor and indo
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Scenario Crop/Use Method Rate Appli
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humidity conditions. The higher res
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4.3 EnvironmentIdentification of ad
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4.3.9.3 Aquatic environment - Groun
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is considered to be highly improbab
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RiskGroupRQ range Level of risk Use
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RiskGroupRQ range Level of risk Use
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assessment, as the Use Scenario inc
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Nonnegligible1 < RQ < 10Nonnegligib
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Table 12.LifecycleStageImport,manuf
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LifecycleStageUse -bystanderUseScen
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Table 13.Identification of benefici
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value that can be attributed to dic
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Page 65 and 66: the duty of the Crown is not merely
Page 67 and 68: 5.1.7.1 J. Hicking stated that dich
Page 70 and 71: Table 14. Comparative of hazard cla
Page 72 and 73: Crop Pest Active ingredient Preharv
Page 74 and 75: Crop Pest Active ingredient Preharv
Page 76 and 77: SECTION 6- PROPOSALS TO MANAGE RISK
Page 78 and 79: Assessment was carried out with spe
Page 80 and 81: 6.1.11 Controls to protect bystande
Page 82 and 83: Table 16Effect of additional contro
Page 84 and 85: Use Scenario Receptor Level of Risk
Page 106 and 107: have, and notes the following as ar
Page 108 and 109: Table 18Summary of benefits associa
Page 110 and 111: UseScenariosAssessment ofEffectOutc
Page 112 and 113: Substance detailsHSR000126DDVPInsec
Page 116: 7.4 Preliminary Recommendations7.4.
Page 119 and 120: method and LOQ)Water (principle ofm
Page 121 and 122: Appendix B: Environmental Fate of d
Page 123 and 124: Bioconcentration factor Gnathopogon
Page 125 and 126: Table C.2:Scenarios used in exposur
Page 127 and 128: Scenario 3: Vegetables - 1 applicat
Page 129 and 130: FIELD AND STANDARD POND HALFLIFE VA
Page 131 and 132: insectivorous bird7 Passionfruit Sm
Page 133 and 134: 4 Leafyvegetables(BBCH ≥50)4 Leaf
Page 135 and 136: summer)7 passionfruit(BBCH 10-19)7
Page 137 and 138: Ground (lowboom)0.03 0.03 1.07 1.07
Page 139 and 140: Appendix D: Ecotoxicity of dichlorv
Page 141 and 142: ioaccumulationClearance timeLevel o
Page 143 and 144: Table D.5:Toxicity to terrestrial i
Page 145 and 146: Appendix E: Risk Assessment: Enviro
Page 147 and 148: Aquatic organsimsTable E.3:Environm
Page 149 and 150: 12345Crop type Table I.1 (Annex 1)
Page 151 and 152: 7 passionfruit(BBCH 20-39)7 passion
Page 153 and 154: Fruit (tree) 2052 70759 >50Passionf
Page 155 and 156: Appendix F: Human Toxicity of dichl
Page 157 and 158: CONTENTS:Title Page 11 Purpose 2Con
Page 159 and 160: 2 SUBSTANCE IDENTIFICATIONIUPAC nam
Page 161 and 162: However, dichlorvos has genotoxic p
Page 163 and 164: 4 ABSORPTION, DISTRIBUTION, METABOL
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aerosol cans (230-330 g dichlorvos)
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4.3 Metabolism:found in tissues of
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dose of 1.0 mg/kg bw, a single gava
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eports. LD 50 = 46.4 mg/kg b.w. is
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6 ACUTE DERMAL 6.1HSNO Classificati
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7 ACUTE INHALATION 6.1HSNO Classifi
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measured and it was not possible to
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8 SKIN IRRITATION 6.3 & CORROSION 8
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9 EYE IRRITATION 6.4 & CORROSION 8.
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10 RESPIRATORY SENSITISATION 6.5AHS
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Justification for Classification: U
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12 MUTAGENICITY 6.6HSNO Classificat
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ERMA New Zealand CONFIDENTIAL Repor
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The ATSDR (1997) reported:“Dichlo
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•ATSDR (1997): http://www.atsdr.c
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13 CARCINOGENICITY 6.7HSNO Classifi
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fibroadenomas were observed in 6 (1
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• Sex/Numbers:• Test material:
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The NTP Peer Review concluded that:
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concurrent studies for comparison w
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The APVMA (2008a) reported a chroni
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was exposed. The estimated daily in
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14 REPRODUCTIVE TOXICITY 6.8HSNO Cl
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ppm during premating days, signific
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Toxicology, Chemistry and Life Scie
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addition, there was an increase in
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• Maternal toxicity NOAEL =• Ma
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Research Triangle Park, North Carol
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16 REPRODUCTIVE OR DEVELOPMENTAL TO
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17 SPECIFIC TARGET ORGAN TOXICITY 6
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There was a significant dose-relate
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KEY STUDY:• Type of study:• Spe
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BACKGROUND:The APVMA (2008a) also r
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cholinesterases can only be estimat
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Ltd, Sittingbourne Research Center,
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23 OTHER POTENTIAL TOXIC ENDPOINTS2
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―Results“Mortalities and clinic
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1984). QA study. Study conducted ac
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“No information was located on im
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“Comment: These incidents clearly
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25 ACCEPTABLE OPERATOR EXPOSURE LEV
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to pretreatment activity). When the
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cholinesterase inhibition in health
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protect agricultural workers who ha
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Wash: refers to skin washes; Dressi
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Hazard Class/SubclassHazardclassifi
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Hazard Class/SubclassHazardclassifi
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REFERENCES:APVMA, 2008a. ―DICHLOR
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Appendix 1:APVMA - Summary of bench
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“Inhalational NOEL for Occupation
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activity). In fact, treatment was s
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LAST PAGEDichlorvos reassessment -
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Dichlorvos:Occupational, Bystander,
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CONTENTS:Title Page 11 Purpose 2Con
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3ACTIVITY SCENARIOS3.1 Table (I) su
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access of bystanders to treated are
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can reduce dermal exposures to mixe
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contaminated with, respectively 0.0
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The modelling is based upon dischar
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Table II: Occupational Exposure Est
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Table III: Occupational Exposure Es
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Operation / RPE / PPETable IV: Occu
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1.25L product/ha; work rate, 1.25 h
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Application: Air-hose RPE + chem. r
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Application: Half-face RPE + overal
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P for RPE (% penetration): none, 1
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Table X: Occupational Exposure Esti
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provided: work day exposure is limi
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5POST-APPLICATION OR RE-ENTRY WORKE
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D = DFR x TC x DA x WR x AR x P / B
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Re-entry into out-door crops (Scena
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Re-entry into treated glasshouses d
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acceptable 240 minutes after applic
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Re-entry into treated glasshouses u
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Table XVII: Re-entry into glasshous
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lowest use rate (52 mg/m 3 ; 1300g
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DA = percentage dermal absorption [
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Re-entry into treated enclosed indu
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nature of the building itself, not
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Conclusions on re-entry worker expo
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6BYSTANDER & RESIDENT EXPOSURE & RI
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Children’s incidental ingestion o
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Table XX: Spray driftExposure throu
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Exposure through contactwithcontami
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Conclusions on bystander and reside
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Table XXIII: Dichlorvos Use Scenari
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mixing/loading. Mixing/loading fogg
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7.23 Re-entry for ventilation of in
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REFERENCES:APVMA, 2008a. ―DICHLOR
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Appendix 1:Occupational Exposure Es
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FactorExposure (μg/kg a.i. handled
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Inhalation exposure from cylinder c
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[0.01875 x {(0.018 x 0.05) + (2.68
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With half-face respirator (protecti
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With full-body chemical resistant c
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Appendix 4:Occupational Exposure Es
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With overalls and gloves (protectio
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The Dermal Exposure (D) is 2.06 μg
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TTR = turf transferable residues -
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F = fraction of residue retained on
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TTR = transferable residues - the E
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Public Space ApplicationsScenario (
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ERMA New Zealand‟s comment on the
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Enclosed SpaceAgricultural UseOutdo
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Appendix H: Qualitative Descriptors
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1.3. The likelihood applies to the
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Appendix I: Data from which classif
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Endpoint Units * Dichlorvos Propoxu
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Toxicity mixture calculationsSubcla
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Subclass 9.3 -Ecotoxicity to terres
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Table J.1:Existing controls for dic
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TrackingcontrolsIdentification cont
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Table J.2:Summary of default contro
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Hazardous Substances (Classes 1 to
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Hazardous Substances (Classes 6, 8,
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Hazardous Substances (Classes 6, 8,
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(a) means piping that—(i) is conn
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Code I29 Regs 51, 52 Signage requir
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Non-HSNO Act controlsAgricultural C
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Appendix K: Overseas regulatory act
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Product Use Further details ofuseSu
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Risk assessment identified concerns
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Current usesFormulations:Methods of
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CanadaStatusPMRA are undertaking a
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Appendix L: Parties consulted durin
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Animal Products Act 19995. The purp
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14. Regulatory control of these pro
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Zealand‘s trade in primary produc
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processed and stored. It employs ve
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may be taken to risk management in
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Appendix A• Agricultural Compound
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Appendix O: ReferencesACVM (2010) h
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