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

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Assessment was carried out with specific use variables, which arerequired to be specified to ensure that the risk posed is negligible;For use of emulsifiable concentrate formulations, even whenmaximum PPE is worn, exposure to dichlorvos must be restricted.This could be achieved by imposing a maximum application rateand a maximum daily treatment area for manual application;For certain Use Scenarios, maximum PPE may be insufficient toprevent exposure risks during mixing and loading. In theseinstances, restriction of the maximum daily mixing/loading quantityis required.6.1.6.5 Restricted entry intervals (REIs)6.1.7 Controls to protect environmentRestrictions on the conditions of entry into treated buildings willensure that exposure to dichlorvos can be managed;Entry into treated buildings during an REI poses a risk unlessminimum levels of PPE are adhered to;Entry into treated buildings during an REI must be for specifictasks only, such as initiating ventilation;Entry into treated buildings during an REI for certain tasks must berestricted to a specific length of time that an operator may spend perday inside treated buildings;Re-entry exposures arising from entry into buildings treated atapplication rates in excess of those modelled are likely to be nonnegligible.Maximum application rates should be imposed;6.1.7.1 No quantitative modelling of environmental exposure arising from indooruse of dichlorvos has been performed. Nevertheless, washing of treatedareas, or drainage from greenhouse watering could lead to contaminationof the environment. APVMA (2008) recognise this as an issue applyingthe control ‗Do not allow drainage water from freshly treated areas tocontaminate streams, rivers or waterways‘.6.1.8 It was suggested by Rentokil during the preparation of this application, that thecontrols on dichlorvos would be strengthened by making it subject to a ControlledSubstance Licence. A CSL ensures that the person handling the product has anApproved Handler certificate and has passed a police check. It does not change thecontrols that a user should adopt when handling the substance and so does not reducetheir risk, or that of bystanders or the environment. For these reasons, ERMA NewZealand does not believe that adoption of the CSL control would reduce the risksfrom use of dichlorvos and it is not proposed as a possible control option.Use Scenario 26-29: Indoor and outdooe use (domestic)6.1.9 Controls to protect applicators (domestic)6.1.9.1 Restrict use to commercial operators only:Dichlorvos reassessment – application Page 78 of 436
6.1.9.2 Specified PPE/RPE:ERMA New Zealand considers that use of PPE/RPE is highlyimprobable for domestic users. As ERMA New Zealand considersthat use of PPE / RPE is a necessity for safe use of dichlorvos indomestic settings, removal of usage by non-commercial applicatorsis required to ensure that by-standers are not exposed.Applicators will be protected if they wear appropriate PPE/RPEduring application;Entry into a treated area would only be allowed if appropriatePPE/RPE was worn during any REI.6.1.9.3 Application restrictions:Assessment was carried out with specific use variables, which arerequired to be specified to ensure that the risk posed is negligible;If PPE/RPE is not worn during application, applicators may beprotected from exposure by requiring automated application ofdichlorvos;In addition, remote control of application will allow the applicatorto leave the application area before any dichlorvos is released;When applied manually, a maximum treatment area and applicationrate will ensure that the risks of exposure are negligilble.6.1.9.4 Restricted entry intervals:ERMA New Zealand considers that exposure to persons re-enteringthe treated area will be, at worse, similar to Use Scenarios 24 and25, given the likely treatment areas and application rates.Restricting access to treated areas will provide protection tobystanders (in particular residents) entering a treated area;The duration of the required REI will be influenced by the level ofPPE and RPE worn.Use Scenario 30: Outdoor use (public areas)6.1.10 Controls to protect workers6.1.10.1 Specified PPE:The quantitative assessment, carried out assessing a range of levelsof PPE (including RPE), indicates that even with full PPE the levelof risk is non-negligible, and alternative controls are required toensure that the level of risk to operators is reduced to negligible.6.1.10.2 Application methods and maximum daily treatment area:Restricting the daily treatment area will provide a means to reducethe daily exposure of operators;Dichlorvos reassessment – application Page 79 of 436
Page 1 and 2:
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
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
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 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
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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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