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

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Comparison of levels of concern (Table E.1) to the risk quotient in Table E.3 showshigh acute risk to invertebrates in the freshwater environment. The risks to fish andaquatic plants are low. This conclusion is based on Tier 0 modelling of exposure(GENEEC2).To explore risk reduction options, ERMA New Zealand used the AgDrift model toestimate the buffer zone that would reduce exposure through spray drift to aconcentration unlikely to cause acute toxicity. The receiving water was defined as a 30cm deep pond. Spray drift is only one route of exposure by which dichlorvos willcontaminate the aquatic environment, but given the rapid dissipation of dichlorvos itwill be important. The model indicated that even for the lowest application rate (800 gai/ha), a buffer zone > 304 meters is required to reduce the receiving waterconcentration to less than the lowest acute EC/LC 50 .GroundwaterTier 0 modelling of concentrations in groundwater predicts concentrations from 0.00069to 0.0036µg/L. In the EU, 0.1 µg/L is the concentration above which the predictedconcentration is considered to be unacceptable. As this level of concern is not exceededERMA New Zealand considers the risks for groundwater are low.BirdsThe avian toxicity assessment was performed according to ―Risk Assessment to Birdsand Mammals (EFSA 2008)‖. The risk assessment is based on a TER (toxicity-exposureratio) approach. For pesticides in general, mortality is unlikely when TER ≥ 10 (acuterisk). No assessment of chronic risk was made due to the rapid dissipation ofdichlorvos in the environment.Table E.4:Acute avian risk assessment – screening stepScenario Crop 1 IndicatorSpecies 2 LD 503DDD 4 TER 5 valueTrigger1 strawberries Small omnivorous bird 9.18 127.04 0.07
12345Crop type Table I.1 (Annex 1) and Appendix 10Species type Table I.1 (Annex 1) and Appendix 10Geometric mean if multiple species testedDDD = daily dietary doseToxicity-exposure ratio = LD 50 / Estimated environmental concentrationFor all scenarios the toxicity:exposure ratio triggers higher tier risk assessment.Table E.5:Acute avian risk assessment- first tier assessmentScenario Crop 1 IndicatorSpecies 2 LD 5031 Strawberry(BBCH 10-19)1 Strawberry(BBCH 20-39)1 Strawberry(BBCH ≥40)1 Strawberry(BBCH 10-19)1 Strawberry(BBCH ≥20)3 Cereals(BBCH 10-19)3 Cereals (BBCH 20-29)3 Cereals3 Cereals(BBCH 30-39)(BBCH ≥40)3 Leafy vegetables(BBCH 10-49)3 Leafy vegetables(BBCH ≥50)3 Leafy + fruitingvegetables and pulses(BBCH 10-19)3 Leafy + fruitingvegetables and pulses(BBCH 20-49)3 Leafy + fruitingvegetables and pulses(BBCH ≥50)3 Leafy vegetables andpulsesDDD 4 TER 5 TriggervalueSmall omnivorous bird 9.18 19.2 0.48
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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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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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Page 98 and 99: Use Scenario Receptor Level of Risk
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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 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: Aquatic organsimsTable E.3:Environm
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
Page 165 and 166: aerosol cans (230-330 g dichlorvos)
Page 167 and 168: 4.3 Metabolism:found in tissues of
Page 169 and 170: dose of 1.0 mg/kg bw, a single gava
Page 171 and 172: eports. LD 50 = 46.4 mg/kg b.w. is
Page 173 and 174: 6 ACUTE DERMAL 6.1HSNO Classificati
Page 175 and 176: 7 ACUTE INHALATION 6.1HSNO Classifi
Page 177 and 178: measured and it was not possible to
Page 179 and 180: 8 SKIN IRRITATION 6.3 & CORROSION 8
Page 181 and 182: 9 EYE IRRITATION 6.4 & CORROSION 8.
Page 183 and 184: 10 RESPIRATORY SENSITISATION 6.5AHS
Page 185 and 186: Justification for Classification: U
Page 187 and 188: 12 MUTAGENICITY 6.6HSNO Classificat
Page 189 and 190: ERMA New Zealand CONFIDENTIAL Repor
Page 191 and 192: The ATSDR (1997) reported:“Dichlo
Page 193 and 194: •ATSDR (1997): http://www.atsdr.c
Page 195 and 196: 13 CARCINOGENICITY 6.7HSNO Classifi
Page 197 and 198: 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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