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

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Overseas regulatory status of dichlorvosDichlorvos-containing substances have been reviewed in a number of countries: United Statesof America (USEPA), Australia (APVMA), Canada (PMRA) and Europe (EU). Thesereviews have resulted in restrictions, prohibitions or voluntary removal from the market.Risks, costs and benefits of use in New ZealandThe risks, costs and benefits of the use of dichlorvos in New Zealand have been assessed.Exposure is based on how a substance is used. ERMA New Zealand carried out its exposuremodelling based on Use Scenarios detailed in Table ES. 4:Table ES. 4Use scenarios evaluated in this application.UseOutdooragricultural useUse Scenarios 1 – 8Indoor agriculturaluseUse Scenarios 9 –16Indoor nonagriculturaluseUse Scenarios 17 –25Domestic useUse Scenarios 26 –29Outdoor use inpublic areasUse Scenario 30Biosecurity useUse Scenario 31Manufacture forexportUse Scenario 32Application detailsUsed on variety of crops (including berries, vegetables, cereals, fruit);800 – 2052 g a.i. / ha, up to 2 times per year, low boom application of EC formulation.Variety of glasshouse crops and in mushroom houses;0.05 g a.i. / m 3 , up to 2 times per year, automatic fogging application of RTU gas orEC formulation;1800 g a.i. / ha, up to 2 times per year, manual hand-held spray application of ECformulation.Enclosed space (industrial) usage;0.05 g a.i. / m 3 , up to 2 times per year, automatic fogging application of RTU gas orEC formulation;0.1 g a.i. / m 2 , up to 2 times per year, manual hand-held spray application of ECformulation.Indoor and outdoor use on surfaces, cracks, crevices;0.25 g a.i. / m 2 , up to 2 times per year, aerosol application of RTU gas.0.3 g a.i. / m 2 , up to 2 times per year, manual spray application of RTU liquid.1000 g a.i. / ha, 1 time per year, manual fogging application of EC formulation.DDVP strips used in biosecurity fruit fly monitoring programme;Up to 90 DDVP strips placed per operator per day, at upto 0.033 g a.i. / ha.Substance exported from New Zealand prior to use.Risks and benefits to the environment and human healthERMA New Zealand did not identify any beneficial effects to the environment or humanhealth from the use of dichlorvos.ERMA New Zealand‘s interim evaluation indicates that the risks range from negligible tohigh to the environment and human health associated for use of dichlorvos in New Zealand.Dichlorvos reassessment – application Page 8 of 436
ERMA New Zealand‘s recommendations include measures that it considers will reduce thelevels of risk to negligible, which include use restrictions or for some Use Scenarios,prohibition of use for that purpose.The risks to consumers exposed to dichlorvos residues in food have not been considered byERMA New Zealand in this reassessment. Dietary exposures and risks are evaluated by theNew Zealand Food Safety Authority under the Food Act 1981.ERMA New Zealand has identified alternative products that are based on different activeingredients for all of the label use patterns of dichlorvos as an agricultural plant protectionproduct. The alternatives present a range of hazard classifications, some of lower, some ofgreater hazard than dichlorvos. Hazard assessment is not an indication of the risk posed by asubstance, since exposure is not taken into account, but can be used as an indicator ofpotential to cause effects.ERMA New Zealand notes that the unique combination of properties that dichlorvospossesses mean that alternatives for direct replacement for certain non-agricultural uses arenot readily identifiable.Risks and benefits to society and communitiesERMA New Zealand‘s interim evaluation indicates that:the level of indirect benefit to public health (i.e. reduction in adverse effectsthrough control of pests, such as cockroaches or fleas) through use of dichlorvosin large scale facilities, public buildings or public amenity is minimal, and is atleast likely to occur, resulting in a low level of positive effect.No potentially significant benefits or positive effects as a result of theunavailability of the substances have been identified.Risks and benefits to the market economyERMA New Zealand‘s interim evaluation indicates that:the overall benefit of dichlorvos to the horticulture sector, and specifically theglasshouse production of tomatoes, capsicum and cucumber are at least low;the overall benefit of dichlorvos for countering biosecurity incursions, the level ofbenefit on trade has been assessed low to medium;the positive effects of its use for the treatment of large structures outweigh theadverse effects.Relationship of Māori to the environmentIn preparing this application, ERMA New Zealand has not conducted a specific Māoriconsultation but the impression gained from a hui with iwi/Māori resource managers is thatunless substances provide clear benefits to outweigh potential risk, they generally oppose theongoing use of hazardous substances. In the absence of further information regardingbenefits, it is expected that submissions from Māori would generally seek the revocation ofthe approvals for dichlorvos and its formulations.Overall evaluationERMA New Zealand concludes that, with current controls in place, non-negligible risks to theenvironment and human health may be posed.Dichlorvos reassessment – application Page 9 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: Aerosol containing 50 g/kgdichlorvo
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 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
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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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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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