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

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Table 11.Table 12.Table 13.Table 14.Summary of Restricted Entry Intervals (REI) and restrictions for use ofdichlorvos-containing substances. 52Summary of the level of risk posed by use of dichlorvos-containingsubstances. 55Identification of beneficial effects on society and the economy fromimportation and use of dichlorvos 59Comparative of hazard classifications of other insecticide activeingredients applied to products on which dichlorvos is used. 70Table 15. Summary of Use Scenarios. 81Table 16. Effect of additional controls on the level of risk. 82Table 17.Summary of risks for Use Scenarios and Outcome Scenarios fordichlorvos-containing substances. 107Table 18 Summary of benefits associated with scenarios. 108Table 19. Overall evaluation – summary of combined non-negligible effects. 109Table 20.Table 21.Table 22.Outcome Scenarios for approvals. ―Restricted use‖ includes withdrawalof specific Use Scenarios. 110Summary of the proposed variations to approvals for dichlorvos anddichlorvos-containing substances. 111Summary of proposed hazard classifications for dichlorvos anddichlorvos-containing substances. 114Dichlorvos reassessment – application Page 4 of 436
EXECUTIVE SUMMARYIn briefERMA New Zealand proposes that the approvals for dichlorvos and dichlorvos-containingsubstances be modified to restrict the way the substances are used, by prohibiting outdooragricultural or public area use, and applying additional use restrictions for other uses. ERMANew Zealand also proposes to modify the hazard classifications of dichlorvos anddichlorvos-containing substances.This is only a preliminary recommendation by ERMA New Zealand. A final decisionwill be made by members of the Authority itself, after consideration of publicsubmissions and evidence provided at public hearings.The Authority‘s decision will be based on whether or not the positive effects (benefits) ofusing dichlorvos outweigh the negative effects (risks and costs) of its use – after takingaccount of all safety precautions that might be imposed and the likely effects of the substancebeing unavailable. If the benefits outweigh the risks and costs, the Authority may approve thecontinued use of dichlorvos in New Zealand for some or all of its current uses (possibly withstricter controls or with further restrictions on use). If the benefits do not outweigh the risksor costs then the Authority may decide to revoke the approval for substances containingdichlorvos.The applicationThis application is made by the Chief Executive of ERMA New Zealand for the reassessmentunder the Hazardous Substances and New Organisms Act 1996 of dichlorvos and ofsubstances containing dichlorvos.To assist in preparing this application, ERMA New Zealand has obtained information from avariety of sources in New Zealand:Adria Crop Protection (Len Stulich)Auckland Regional Council (Sandi Murray)BOCEcolab (Eric Van Essen)Environment Bay of Plenty (David Phizacklea)Environment Canterbury (Ron McCraw)Fonterra (Roger Andela)Foundation for Arable Research (Nick Pyke)Greater Wellington (Ray Clarey)Horticulture New ZealandMAF Biosecurity (Vivien Thompson)Meadow Mushrooms Ltd (Gill Hoglund)Northern Distributors (Les Bryant)Northland Cymbidium Grower‘s AssociationOrion Crop Protection (John Hicking)Dichlorvos reassessment – application Page 5 of 436
Page 1 and 2: Application for the Reassessment of
Page 3: 6.1 Evaluation of options to streng
Page 7 and 8: Aerosol containing 50 g/kgdichlorvo
Page 9 and 10: ERMA New Zealand‘s recommendation
Page 11 and 12: 26 - 29Outdoor public space usage30
Page 13 and 14: Substance details1-8,11-16,20-25,30
Page 15 and 16: 1.2.3 In 2008, the Environmental Ri
Page 17 and 18: Table 1. Dichlorvos-containing subs
Page 19 and 20: public environments and use for bio
Page 21 and 22: available to it. In preparing this
Page 23 and 24: 3.3 International regulatory positi
Page 25 and 26: 3.6 Classification3.6.1 The HSNO cl
Page 27 and 28: Hazard Class /SubclassClassificatio
Page 29 and 30: Hazard Class /SubclassClassificatio
Page 31 and 32: Rates:Fogging: 13 ml / litre (water
Page 33 and 34: BV2 SurfaceInsecticideBV2 SurfaceIn
Page 35 and 36: Table 7.Dichlorvos outdoor and indo
Page 37 and 38: Scenario Crop/Use Method Rate Appli
Page 39 and 40: humidity conditions. The higher res
Page 41 and 42: 4.3 EnvironmentIdentification of ad
Page 43 and 44: 4.3.9.3 Aquatic environment - Groun
Page 45 and 46: is considered to be highly improbab
Page 47 and 48: RiskGroupRQ range Level of risk Use
Page 49 and 50: RiskGroupRQ range Level of risk Use
Page 51 and 52: assessment, as the Use Scenario inc
Page 53 and 54: 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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outbreak, MAF‘s ability to demons
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the duty of the Crown is not merely
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5.1.7.1 J. Hicking stated that dich
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Table 14. Comparative of hazard cla
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Crop Pest Active ingredient Preharv
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Crop Pest Active ingredient Preharv
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SECTION 6- PROPOSALS TO MANAGE RISK
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Assessment was carried out with spe
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6.1.11 Controls to protect bystande
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Table 16Effect of additional contro
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Use Scenario Receptor Level of Risk
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have, and notes the following as ar
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Table 18Summary of benefits associa
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UseScenariosAssessment ofEffectOutc
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Substance detailsHSR000126DDVPInsec
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Table 22.there are no practicable r
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7.4 Preliminary Recommendations7.4.
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method and LOQ)Water (principle ofm
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Appendix B: Environmental Fate of d
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Bioconcentration factor Gnathopogon
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Table C.2:Scenarios used in exposur
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Scenario 3: Vegetables - 1 applicat
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FIELD AND STANDARD POND HALFLIFE VA
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insectivorous bird7 Passionfruit Sm
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4 Leafyvegetables(BBCH ≥50)4 Leaf
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summer)7 passionfruit(BBCH 10-19)7
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Ground (lowboom)0.03 0.03 1.07 1.07
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Appendix D: Ecotoxicity of dichlorv
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ioaccumulationClearance timeLevel o
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Table D.5:Toxicity to terrestrial i
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Appendix E: Risk Assessment: Enviro
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Aquatic organsimsTable E.3:Environm
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12345Crop type Table I.1 (Annex 1)
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7 passionfruit(BBCH 20-39)7 passion
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Fruit (tree) 2052 70759 >50Passionf
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Appendix F: Human Toxicity of dichl
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CONTENTS:Title Page 11 Purpose 2Con
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2 SUBSTANCE IDENTIFICATIONIUPAC nam
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However, dichlorvos has genotoxic p
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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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