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

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SECTION 3– THE SUBSTANCE AND ITS LIFECYCLE3.1 Identification of the substanceTable 2.Identity of dichlorvos.Summary Information dichlorvosActive substance (ISO Common Name)Other common namesFunctionChemical name (IUPAC)DichlorvosDDVPinsecticide2,2-Dichlorovinyl dimethyl phosphateCAS No 62-73-73.1.1 Dichlorvos is sold as an aerosol in quantities of 6 and 36 kg with CO 2 propellant tobe used for the treatment of greenhouses, farm buildings and other enclosed spaces.It is also sold on the domestic market in aerosols containing 3.1 g of dichlorvos, coformulatedwith propoxur and isopropyl alcohol as the propellant.3.1.2 Dichlorvos is sold as an emulsifiable concentrate containing 1000 or 1140 gdichlorvos/litre in 1 and 5 litre containers. It is sprayed outdoors and indoors and isused in fogging equipment for use in enclosed spaces and for public healthapplications. Dichlorvos is also sold on the domestic market as a ready-to-use liquidcontaining 4.4 g/litre dichlorvos and 9.6 g/litre propoxur.3.1.3 DDVP Insecticide Strip is a solid blue-coloured flexible PVC strip weighing 2.6 g,with dimensions of 25 x 15 x 5 mm. Each strip contains 0.48-0.52 g dichlorvos. Thestrips are used by Biosecurity New Zealand as part of their fruit fly surveillanceprogramme.3.2 Regulatory History in New Zealand3.2.1 Dichlorvos (active ingredient) was transferred to the HSNO Act in the ChemicalsTransfer Notice (01 July 2006).3.2.2 Five formulations containing dichlorvos were transferred to the HSNO Act in 2006.These were (together with their HSNO approval numbers): Aerosol containing 50g/kg dichlorvos, HSR000212; Emulsifiable concentrate containing 1000 g/litredichlorvos , HSR000211; Emulsifiable concentrate containing 1140 g/litredichlorvos, HSR000213; Flammable aerosol containing 3.1 g/litre dichlorvos and 8.7g/litre propoxur, HSR000207; Ready to use liquid containing 4.4 g/litre dichlorvosand 9.6 g/litre propoxur, HSR000209.3.2.3 Two products containing dichlorvos have been approved individually under theHSNO Act, DDVP Insecticide Strip (Approval HSR000126), and J72.03(HSR001757), the latter for export only.3.2.4 Currently (13 Jan 2010) four products containing dichlorvos are registered under theAgricultural Compounds and Veterinary Medicines (ACVM) Act (Table 1). Twoproducts (BV2 Suface Insecticide and BV2 Surface Insecticide Bulk) do not requireACVM registrations.Dichlorvos reassessment – application Page 22 of 436
3.3 International regulatory position3.3.1 In recent years, dichlorvos has been subject to review in Australia (APVMA), theUSA (US EPA), Canada (PMRA) and Europe (EU). Details of these reviews arecontained in Appendix K and are summarised below.3.3.2 The APVMA (2008) is proposing to restrict the use of dichlorvos. Remaining usesare those in which exposure of operators and bystanders is minimised either byautomatic application to enclosed spaces or use of small volumes, for example fortreatment of wasp nests. In either case a minimum of elbow length butyl rubbergloves and chemical resistant clothing and in many applications a respirator isprescribed. Restricted entry intervals of 96 hours (4 days) for enclosed spaces or 4hours for glasshouses are prescribed. Indoor domestic use is not expected giventhese restrictions. Currently the only application involving field crops in Australia isfor avocados, but the APVMA proposed that broadacre application to this cropshould be discontinued. Veterinary treatment of horses using adichlorvos/oxibendazole paste is supported.3.3.3 In the USA dichlorvos is registered to control insect pests in agricultural sites,commercial, institutional and industrial sites; in and around homes; and on pets. It isalso used in greenhouses; mushroom houses; storage areas for bulk, packaged andbagged raw and processed agricultural commodities; food manufacturing/processingplants; animal premises; and non-food areas of food-handling establishments. It isalso registered for direct dermal pour-on treatment of cattle, and treatment of poultryhouses. It is not registered for direct use on any field grown commodities. Shortlyprior to completion of the USEPA (2006) review, the registrants withdrew use ofhand-held foggers in mushroom houses, greenhouses and warehouses, addedcoveralls to the required PPE for mushroom house hose-end sprayers and setrestricted entry intervals of 24 hours, reducible to 18 hours in mushroom houses and12 hours in greenhouses, if residual concentrations were demonstrated to have fallenbelow specified concentrations. Labelling of pest strips was also to be amended tothe effect that they should only be used in areas occupied for < 4 hours / day and foragricultural commodities. All other uses were retained (USEPA, 2006).3.3.4 In Canada, interim measures similar to the changes implemented in USEPA (2006)have been introduced (PMRA, 2008).3.3.5 Dichlorvos is not registered for use as a plant protection product in Europe. Prior toits removal from Annex 1, its use was supported only on flower bulbs (EU, 2007).Dichlorvos use as a biocide is under review under the Biocides Directive.3.4 Mode of action3.4.1 Dichlorvos is an acetylcholinesterase inhibitor active through inhalation, contact andoral exposure.3.5 Review of hazardous properties3.5.1 The physico-chemical properties of dichlorvos and its formulations are described inAppendix A.3.5.2 The toxicology of dichlorvos is summarised in Appendix G.3.5.3 Dichlorvos is of high acute toxicity by oral, dermal and inhalation routes ofexposure. It is an eye and skin irritant and contact sensitiser. Of the chronic toxicityclassifications, dichlorvos attracts 6.6B (suspected human or known animalmutagen), 6.7B (suspected human or known or presumed animal carcinogen) and6.9A target organ toxicant, on account of its effects by single exposure for oral,Dichlorvos reassessment – application Page 23 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: available to it. In preparing this
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 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
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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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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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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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