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

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7.4 Preliminary Recommendations7.4.1 ERMA New proposes the revised classifications (Table 22) are adopted fordichlorvos and dichlorvos-containing substances.7.4.2 Discontinue Use (Outcome Scenario (c)) is proposed for outdoor agricultural andpublic area uses.7.4.3 Continue Use (Outcome Scenario (a)) is proposed for dichlorvos (approval numberHSR002838).7.4.4 Continue Use (Outcome Scenario (a)) is proposed for J72.03 (approval numberHSR001757).7.4.5 Restrict Use / Additional Controls (Outcome Scenario (b)) is proposed for thefollowing dichlorvos-containing substances:DDVP Insecticide Strip (approval number HSR000126);Flammable aerosol containing 3.1 g/litre dichlorvos and 8.7 g/litre propoxur(approval number HSR000207);Ready to use liquid containing 4.4 g/litre dichlorvos and 9.6 g/litre propoxur(approval number HSR000209);Emulsifiable concentrate containing 1000 g/litre dichlorvos (approval numberHSR000211);Aerosol containing 50 g/kg dichlorvos (approval number HSR000212);Emulsifiable concentrate containing 1140 g/litre dichlorvos (approval numberHSR000213).7.4.6 ERMA New Zealand proposes that these recommendations are phased-in over a 12month period.Signed_______________________________________Chief Executive, ERMA New Zealand.Dated ____________23 November 2010____________Dichlorvos reassessment – application Page 116 of 436
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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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outbreak, MAF‘s ability to demons
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Page 72 and 73: Crop Pest Active ingredient Preharv
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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 114 and 115: Table 22.there are no practicable r
Page 118 and 119: Table A.2:Methods of analysisAnalyt
Page 120 and 121: GC/FPD (cross reference KIIA 4.2.4/
Page 122 and 123: Degradates, 2,2-dichloroacetic acid
Page 124 and 125: Appendix C: Environmental Exposure
Page 126 and 127: Table C.3:Output from GENEEC2 expos
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Page 130 and 131: Terrestrial exposureBirds - food ex
Page 132 and 133: 3 Cereals3 Cereals(BBCH 30-39)(BBCH
Page 134 and 135: (BBCH 71-89)3 Bush &canefruit(BBCH
Page 136 and 137: Plants and soil organisms, off-targ
Page 138 and 139: The vegetation distribution factor
Page 140 and 141: eastern oyster(Crassostreavirginica
Page 142 and 143: JapanesequailJapanesequailJapaneseq
Page 144 and 145: Environmental classificationOn the
Page 146 and 147: TER= LD 50 / estimated environmenta
Page 148 and 149: Comparison of levels of concern (Ta
Page 150 and 151: (BBCH 10-19)3 Leafy + fruitingveget
Page 152 and 153: Table E.8:Earthworm -TER in-fieldAp
Page 154 and 155: Restricting application rates or fr
Page 156 and 157: 1 PURPOSE1.1 The purpose of this re
Page 158 and 159: 19 Specific Target Organ Toxicity 6
Page 160 and 161: 3 TOXICOLOGICAL HAZARD PROFILE - IN
Page 162 and 163: urinary parameters, or on organ wei
Page 164 and 165: (Casida et al., 1962). Dichlorvos w
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The US EPA (2006) reported that:4.2
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4.4 Elimination:CalDRP (1996) repor
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5 ACUTE ORAL 6.1HSNO Classification
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The ATSDR (1997) reported:“A numb
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in Table 10.1 of the User Guide to
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autopsy: distended lung; oedematous
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Acute inhalation toxicity of dichlo
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Wuppertal-Elberfeld. Report date: 2
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• Reference source:• Reliabilit
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11 CONTACT SENSITISATION 6.5BHSNO C
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persistent vertical, mildly erythem
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In summary, dichlorvos is mutagenic
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The APVMA (2008a) summarised:―Num
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“The lack of dichlorvos genotoxic
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following i.p. administration of si
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historical control range (0-28%). C
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(APVMA, 2008a)• NOAEL < 4 mg/kg b
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FemaleLogisitic Regression Tests P
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BACKGROUND:The ATSDR (1997) summari
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―Dichlorvos has been formulated f
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“Mortalities, Clinical Signs and
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carcinogenicity found in mice follo
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ChE activity: There was a significa
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from Charles River Laboratories (CR
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eceiving dichlorvos by capsule for
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• Endpoint:Appearance, behaviour,
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• Endpoint:Appearance, behaviour,
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live fetuses were weighed and exami
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evidence is insufficiently suggesti
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(p
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June 1992. Report date: 15th Januar
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• Test Guideline:No information;
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surviving animals appeared to behav
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of 2-year treatment period. No effe
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ChE inhibition: There was a clear d
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levels, analytical dichlorvos conce
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21 SPECIFIC TARGET ORGAN TOXICITY 6
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odyweight depressed by 10-13% (only
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― … Total and differential leuc
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[See earlier Sections for Key Studi
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“Conclusions: A single oral dose
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“Necropsy: Macroscopic examinatio
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24 HUMAN EXPOSURE REPORTSThe APVMA
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volunteers. Erythrocyte acetylcholi
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25.1 Key Study:KEY STUDY: Oral• T
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• Species:• Strain:• Sex/Numb
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impairment of visual performance, n
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Absorption factors:[See Section 4 A
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26 SUMMARY & CONCLUSIONSCLASS 6 & 8
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Hazard Class/SubclassHazardclassifi
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Critical NOAEL/LOAEL used for occup
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WHO, 1988. ―INTERNATIONAL PROGRAM
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―It is considered that the most s
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and on a weekly basis for 4 weeks:
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Plasma ChE activity in additional m
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Appendix G: Human Health Risk Asses
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1 PURPOSE1.1 The purpose of this re
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2SUBSTANCE IDENTIFICATIONIUPAC name
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Table I: Dichlorvos Use ScenariosSc
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4OPERATOR EXPOSURE & RISK ASSESSMEN
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14, the mixing/loading component of
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enclosed space applications. Head/n
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handled. The APVMA considered that
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abcdeUK CRD interpretation of the G
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Application: no PPE 57 0.2955 )abcU
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Table V: Occupational Exposure Esti
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Table VI: Occupational Exposure Est
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Table VII: Occupational Exposure Es
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Operation / RPE / PPETable VIII: Oc
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Table IX: Residential Exposure Esti
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Conclusions on operator exposure es
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25, surface spraying of larger spac
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and peas 20 minutes after applicati
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5.18 The Task Specific Factors (TSF
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abcdefgUK CRD Guidance for Post-App
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Table XIII: Re-entry into glasshous
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5.34 No REI for treated glasshouses
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At 72 mg dichlorvos/m 3 (1800g a.i.
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5.46 In this instance, after treatm
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Re-entry into treated mushroom hous
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[Note: P001132 Nuvos label gives a
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Table XVIII: Re-entry into building
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characteristics of different buildi
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5.88 Re-entry for ventilation of in
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in the EPA Exposure Factors Handboo
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determine the Risk Quotient (RQ). T
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Bystander and resident exposure & r
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indicates the likelihood of an unac
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7 SUMMARY AND CONCLUSIONS7.1 TCL es
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7.4 Cymbidium: EC dichlorvos soluti
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7.16 Re-entry into cereals treated
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7.31 Estimated exposures to childre
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UK CRD, 2008c. ―OPERATOR EXPOSURE
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espirator with a dust/mist prefilte
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Appendix 2:Occupational Exposure Es
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B)Operator exposures during manual
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[0.625 x {(0.018 x 0.05) + (2.68 x
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Appendix 3:Occupational Exposure Es
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Then accepting the inhalation absor
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The APVMA considered that the predi
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Appendix 5Re-entry Worker Exposure
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Appendix 6Resident Exposures to Dic
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Object to mouth exposures were calc
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Domestic Indoor Surface Application
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Children‘s total exposure was est
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Last PageDichlorvos reassessment -
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Risk QuotientDichlorvos Mixing Load
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Open SpacePublic SpaceManual Foggin
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MajorMassiveSignificant irreversibl
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Table H4.4Level of riskMagnitude of
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Toxicity and environmental data on
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Endpoint Units * L M N 1N 2 N 3 N 4
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Ecotoxicity mixture calculationsSub
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Appendix J: Current ControlsHSNO Ac
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PackagingcontrolsDisposalcontrolsEm
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Controlsrelating toStationaryContai
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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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Hazardous Substances (Personnel Qua
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Hazardous Substances (Identificatio
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y the previous source of manufactur
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Table J.6:Agricultural Compounds an
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Outcome of risk assessment for form
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Product Use Further details ofuseAp
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5. Include in label instructions a
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For each of the US permitted uses,
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Current UsesIn the past dichlorvos
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Appendix M: ACVM and other NZFSA ad
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organismsProviding generalassessmen
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egistration subject to conditions;
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34. The MRLs vary from country to c
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Production Food Safety (APFSWG) whi
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64. Based on a Joint meeting of the
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Appendix N: Plant & Food Research R
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Urban D.J., Cook, N.J. (1986). Haza
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