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

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Terrestrial exposureBirds – food exposure terrestrial and aquatic food chains.The avian toxicity assessment was performed according to ―Risk Assessment to Birds andMammals‖ (EFSA 2008). Dichlorvos is considered not to be bioaccumulative, so this was nottaken into account in the assessment. The bird exposure assessment is based on theconcentration of dichlorvos in the diet and the quantity of food consumed. The ‗daily dietarydose‘ (DDD) is defined by the food intake rate of the species of concern (i.e. the indicatorspecies), the body weight of the species of concern, the concentration of a substance in/onfresh diet and the fraction of diet obtained in the treated area. The estimated food intake ratesare based on the daily energy expenditure of the species of concern, the energy in the food,the ‗energy‘ assimilation efficiency of the species of concern, and the moisture content of thefood. The above information is combined into a single value for specific species-cropcombinations and termed a ‗shortcut value‘. The daily dietary dose for a single applicationcan be calculated by multiplying the shortcut value with the application rate. When asubstance is applied more than once a multiple application factor for 90 th percentile residuedata is taken into account (MAF 90 ).DDD single application = application rate (kg/ha) x shortcut valueDDD multiple applications = DDD single application x MAF 90The toxicity-exposure ratio (TER) can be calculated by dividing the LD 50 value by the dailydietary dose (Appendix F).TER = LD 50 / DDDThe first step of the risk assessment is the ‗screening step‘ that uses an indicator species andworst case assumptions regarding exposure. If a substance and its use do not pass thescreening step, then the next step is the first-tier risk assessment. This uses more realisticexposure estimates (i.e. crop growth stages) along with a ‗generic focal species‘.ERMA New Zealand calculated the DDD values for the indicator species for the differentcrops and the results for dichlorvos are shown for acute toxicity in Tables C4 (screening step)and C5 (Tier 1). No assessment was made for chronic toxicity due to the short half-life ofdichlorvos.Table C4:Daily dietary dose used in the screening step for the assessment of acute toxicityof dichlorvosScenario Crop 1 Species 2Indicator1,3 Strawberries,vegetables,cereals,berries2,4 Strawberries,vegetables,cereals,berriesSmall omnivorousbirdSmall omnivorousbird5 Fruit (trees) Smallinsectivorous birdShort-cutvalue 3(90 th percentileRUD)Applicationrate (kg/ha) MAF 904Dichlorvos reassessment – application Page 130 of 436DDD 5158.8 0.8 1 127.04158.8 0.8 1.4 177.8646.8 2.052 1 96.036 Fruit (trees) Small 46.8 2.052 1.4 134.45
insectivorous bird7 Passionfruit Smallinsectivorous bird8 Passionfruit Smallinsectivorous bird46.8 1.026 1 48.0246.8 1.026 1.4 67.22Additional details provided in EFSA (2008):1Crop type Table I.1 (Annex 1) and Appendix 102Species type Table I.1 (Annex 1) and Appendix 103Residue Unit Dose (90 th percentile) Table I.1 (Annex 1)4 Multiple application factor (90 th percentile) Table 1.1 and Appendix 155 DDD = daily dietary doseTable C5:Daily dietary dose for first tier assessment of acute toxicity dichlorvosScenario Crop 1 IndicatorSpecies 2Short-cutvalue 3(90 th percentileRUD)Applicationrate (kg/ha)MAF 904DDD 51 Strawberry(BBCH 10-19)1 Strawberry(BBCH 20-39)1 Strawberry(BBCH ≥40)1 Strawberry(BBCH 10-19)1 Strawberry(BBCH ≥20)2 Strawberry(BBCH 10-19)2 Strawberry(BBCH 20-39)2 Strawberry(BBCH ≥40)2 Strawberry(BBCH 10-19)2 Strawberry(BBCH ≥20)3 Cereals(BBCH 10-19)3 Cereals (BBCH20-29)SmallomnivorousbirdSmallomnivorousbirdSmallomnivorousbirdSmallinsectivorousbirdSmallinsectivorousbirdSmallomnivorousbirdSmallomnivorousbirdSmallomnivorousbirdSmallinsectivorousbirdSmallinsectivorousbirdSmallomnivorousbirdSmallomnivorous24 0.8 1 19.222.9 0.8 1 18.3210.7 0.8 1 8.5626.8 0.8 1 21.4425.2 0.8 1 20.1624 0.8 1.4 26.8822.9 0.8 1.4 25.6510.7 0.8 1.4 11.9826.8 0.8 1.4 30.0225.2 0.8 1.4 28.2224 0.8 1 19.222.9 0.8 1 18.32Dichlorvos reassessment – application Page 131 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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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
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 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: FIELD AND STANDARD POND HALFLIFE VA
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
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
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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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