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

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ERMA New Zealand was not able to quantitatively assess the riskof exposure to operators arising from the use of dichlorvosimpregnatedinsecticide strips (Use Scenario 31). Given the usepattern described for DDVP Insecticide strips, the criteria used todevelop the Use Scenario, ERMA New Zealand has undertakensemi-quantitative assessment. ERMA New Zealand estimates thatoperators will be exposed to 0.21 mg / hour of operations involvingDDVP strips associated with traps (which includes placing andreplacing strips in traps, and also routine inspection of traps).ERMA New Zealand estimates that operators will be exposed for aduration of 3 hours per day (0.63 mg dichlorvos per day). It hasbeen assumed that exposure will only occur via inhalation, as PPE(i.e. gloves) will be used when handling DDVP strips. Comparingthe quantity of exposure to the AOEL (0.0014 mg/kg bw / day), fora 75 kg operator the daily AOEL equates to 0.105 mg dichlorvos.ERMA New Zealand considers that, whilst the estimations arelikely to be conservative in nature, the magnitude of adverse effectposed to operators is minor to major. ERMA New Zealandconsiders that the likelihood of minor to major adverse effectsoccurring is very unlikely. The level of risk to the health ofoperators is therefore negligible to low.4.4.4.2 Restricted entry exposure to operators:Only a few scenarios for existing uses of dichlorvos gaveacceptable risks for restricted entry workers. Acceptable restrictedentry generally requires the use of PPE and/or RPE plus in mostcases a time period called the Restricted Entry Interval (REI) 6 isalso needed. The level of risk of exposure associated with each UseScenario is detailed in Table 11, arising from restricted entry intotreated areas.ERMA New Zealand considers that the unrestricted entry timeperiods proposed for industrial buildings treated with dichlorvos,indicate that inhalation exposure to dichlorvos is acceptable withoutuse of RPE after such a time. ERMA New Zealand considers thatthe such time periods, with respect to inhalation exposure risk, canalso be imposed on glasshouse and mushroom house use.However,, given that ERMA New Zealand is not able to establish atime period after which dermal exposure has reduced to acceptablelevels, ERMA New Zealand considers that contact with treatedglasshouse and mushroom house crops after treatment require useof PPE to prevent dermal exposure.ERMA New Zealand considers that the semi-quantitativeassessments carried out for operator exposure for Use Scenario 31is appropriate to use for the restricted entry operator exposure6A Restricted Entry Interval (REI) is a time period within which specific restrictions must be met. Examplesof the types of restrictions that may be imposed include use of PPE and RPE, entry is only allowed for certaintasks and for specified durations.Dichlorvos reassessment – application Page 50 of 436
assessment, as the Use Scenario includes operations such asreturning to traps to replace strips and inspection of traps. As aresult, ERMA New Zealand considers that the identified likelihoodsand magnitudes for operator exposure are the same for the operatorrestricted entry exposure risk. ERMA New Zealand considers thatthe magnitude of adverse effect posed to operators is minor tomajor. ERMA New Zealand considers that the likelihood of minorto major adverse effects occurring are very unlikely. The level ofrisk to the health of operators is therefore negligible to low.Dichlorvos reassessment – application Page 51 of 436
Page 1 and 2: Application for the Reassessment of
Page 3 and 4: 6.1 Evaluation of options to streng
Page 5 and 6: EXECUTIVE SUMMARYIn briefERMA New Z
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: RiskGroupRQ range Level of risk Use
Page 53 and 54: Nonnegligible1 < RQ < 10Nonnegligib
Page 55 and 56: Table 12.LifecycleStageImport,manuf
Page 57 and 58: LifecycleStageUse -bystanderUseScen
Page 59 and 60: Table 13.Identification of benefici
Page 61 and 62: value that can be attributed to dic
Page 63 and 64: outbreak, MAF‘s ability to demons
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 100 and 101:
Use Scenario Receptor Level of Risk
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Page 104 and 105:
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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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Page 229 and 230:
Page 231 and 232:
Page 233 and 234:
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 -
Page 277 and 278:
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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