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

Application for the Reassessment of aHazardous Substance under Section 63 ofthe Hazardous Substances and NewOrganisms Act 1996Name of Substance(s):DichlorvosApplication Number:HRC08004Applicant:Chief Executive ERMA New ZealandNovember 2010

ContentsExecutive Summary 5SECTION 1 – THE APPLICATION 141.1 Applicant details 141.2 Background to the application 141.3 Preparation of the application 151.4 Notification and Consultation 16SECTION 2 - THE RISK MANAGEMENT CONTEXT 182.1 Risk management context 182.2 Consideration of Outcome Scenarios 182.3 Identification and assessment process 192.4 Consideration of uncertainty 202.5 Ethical considerations 202.6 Principles of the Treaty of Waitangi (Te Tiriti ō Waitangi) 21SECTION 3 – THE SUBSTANCE AND ITS LIFECYCLE 223.1 Identification of the substance 223.2 Regulatory History in New Zealand 223.3 International regulatory position 233.4 Mode of action 233.5 Review of hazardous properties 233.6 Classification 253.7 Lifecycle 303.8 Use Scenarios 343.9 Existing Controls 39SECTION 4– IDENTIFICATION AND ASSESSMENT OF ADVERSE ANDBENEFICIAL EFFECTS (RISKS, COSTS AND BENEFITS) 404.1 Introduction 404.2 Incidents 404.3 Environment 414.4 Human health and safety 444.5 Summary of exposure risks to the environment and human health. 544.6 Society and communities 574.7 The market economy 584.8 Māori interests and concerns 644.9 International obligations 65SECTION 5 – LIKELY EFFECTS OF DICHLORVOS BEING UNAVAILABLE 665.1 Introduction 665.2 Comparative hazard assessment of alternative plant protection products 69SECTION 6 – PROPOSALS TO MANAGE RISKS 76Dichlorvos reassessment – application Page 2 of 436

6.1 Evaluation of options to strengthen existing controls 766.2 Evaluation of options to reduce risk by restricting use 816.3 Effect of proposed additional controls on the level of risk 81SECTION 7 – OVERALL EVALUATION 1057.1 Evaluation of options to reduce risk by restricting use 1057.2 Overall Evaluation 1077.3 Proposed additions and modifications to controls under section 77A 1107.4 Preliminary Recommendations 116Appendices 117Appendix A:Chemical and physical properties of the active ingredient andmethods of analysis 117Appendix B: Environmental Fate of dichlorvos 121Appendix C: Environmental Exposure modelling 124Appendix D: Ecotoxicity of dichlorvos 139Appendix E: Risk Assessment: Environment dichlorvos 145Appendix F: Human Toxicity of dichlorvos 155Appendix G: Human Health Risk Assessment 276Appendix H: Qualitative Descriptors for Risk/Benefit Assessment 381Appendix I: Data from which classifications derived by mixture rules were derived 385Appendix J: Current Controls 392Appendix K: Overseas regulatory action 411Appendix L: Parties consulted during the preparation of the application 421Appendix M: ACVM and other NZFSA administered legislation 422Appendix N: Plant & Food Research Report on Use 434Appendix O: References 435List of TablesTable 1. Dichlorvos-containing substances covered by this application 1 . 17Table 2. Identity of dichlorvos. 22Table 3. Classification of dichlorvos. 25Table 4. Classification of dichlorvos-containing substances. 26Table 5. Label rates and uses for dichlorvos-containing plant protection products. 30Table 6.Label rates and uses for dichlorvos-containing products for non-plantprotection uses. 32Table 7. Dichlorvos outdoor and indoor plant protection Use Scenarios. 35Table 8. Dichlorvos non-agricultural Use Scenarios. 36Table 9. Identification of potential sources of risk. 40Table 10.Summary of occupational risk quotients for the Use Scenarios ofdichlorvos usage. 46Dichlorvos reassessment – application Page 3 of 436

Table 11.Table 12.Table 13.Table 14.Summary of Restricted Entry Intervals (REI) and restrictions for use ofdichlorvos-containing substances. 52Summary of the level of risk posed by use of dichlorvos-containingsubstances. 55Identification of beneficial effects on society and the economy fromimportation and use of dichlorvos 59Comparative of hazard classifications of other insecticide activeingredients applied to products on which dichlorvos is used. 70Table 15. Summary of Use Scenarios. 81Table 16. Effect of additional controls on the level of risk. 82Table 17.Summary of risks for Use Scenarios and Outcome Scenarios fordichlorvos-containing substances. 107Table 18 Summary of benefits associated with scenarios. 108Table 19. Overall evaluation – summary of combined non-negligible effects. 109Table 20.Table 21.Table 22.Outcome Scenarios for approvals. ―Restricted use‖ includes withdrawalof specific Use Scenarios. 110Summary of the proposed variations to approvals for dichlorvos anddichlorvos-containing substances. 111Summary of proposed hazard classifications for dichlorvos anddichlorvos-containing substances. 114Dichlorvos reassessment – application Page 4 of 436

EXECUTIVE SUMMARYIn briefERMA New Zealand proposes that the approvals for dichlorvos and dichlorvos-containingsubstances be modified to restrict the way the substances are used, by prohibiting outdooragricultural or public area use, and applying additional use restrictions for other uses. ERMANew Zealand also proposes to modify the hazard classifications of dichlorvos anddichlorvos-containing substances.This is only a preliminary recommendation by ERMA New Zealand. A final decisionwill be made by members of the Authority itself, after consideration of publicsubmissions and evidence provided at public hearings.The Authority‘s decision will be based on whether or not the positive effects (benefits) ofusing dichlorvos outweigh the negative effects (risks and costs) of its use – after takingaccount of all safety precautions that might be imposed and the likely effects of the substancebeing unavailable. If the benefits outweigh the risks and costs, the Authority may approve thecontinued use of dichlorvos in New Zealand for some or all of its current uses (possibly withstricter controls or with further restrictions on use). If the benefits do not outweigh the risksor costs then the Authority may decide to revoke the approval for substances containingdichlorvos.The applicationThis application is made by the Chief Executive of ERMA New Zealand for the reassessmentunder the Hazardous Substances and New Organisms Act 1996 of dichlorvos and ofsubstances containing dichlorvos.To assist in preparing this application, ERMA New Zealand has obtained information from avariety of sources in New Zealand:Adria Crop Protection (Len Stulich)Auckland Regional Council (Sandi Murray)BOCEcolab (Eric Van Essen)Environment Bay of Plenty (David Phizacklea)Environment Canterbury (Ron McCraw)Fonterra (Roger Andela)Foundation for Arable Research (Nick Pyke)Greater Wellington (Ray Clarey)Horticulture New ZealandMAF Biosecurity (Vivien Thompson)Meadow Mushrooms Ltd (Gill Hoglund)Northern Distributors (Les Bryant)Northland Cymbidium Grower‘s AssociationOrion Crop Protection (John Hicking)Dichlorvos reassessment – application Page 5 of 436

Rentokil (Jon Thompson)Precautionary approach to determining risksIn the absence of New Zealand-specific exposure data, the assessment largely usesenvironmental and human health models to estimate exposure. These models useconservative assumptions and may overestimate risks.This precautionary approach is consistent with the HSNO Act and regulations. These providethat where there is scientific and technical uncertainty, the Authority must consider themateriality of the uncertainty and if the uncertainty cannot be resolved to its satisfaction, musttake into account the need for caution in managing the adverse effects of the substance.Use of dichlorvos in New ZealandFormulations containing dichlorvos have been registered for use in New Zealand since 1968.In New Zealand dichlorvos is used for the control of crawling and flying insects. Dichlorvosis used in agricultural and non-agricultural situations (Table ES. 1). This informationsummarises known use or label use patterns.Table ES. 1Summary of use of dichlorvos in New Zealand.Agricultural useVegetablesCerealsFruit (including tamarillo, persimmon, berries,passionfruit)Glasshouse crops (capsicum, cymbidium)Non-agricultural useIndoor/enclosed space treatment:Industrial, public access buildingsDomestic useOutdoor treatment of public areasUse in biosecurity fruit-fly monitoring.Mushroom houses8 substances containing dichlorvos are currently approved for use in New Zealand (TableES. 2). Only those substances used in agricultural situations require registration under theACVM Act.Table ES. 2Substances containing dichlorvos approved for use under the HSNO Act.Substance descriptionApproval numbersHSNO ACVMTrade namesDichlorvos [CAS #62-73-7] HSR002838 - -DDVP Insecticide Strip HSR000126 P007362 DDVP Insecticide StripFlammable aerosol containing 3.1g/litre dichlorvos and 8.7 g/litrepropoxurReady to use liquid containing 4.4g/litre dichlorvos and 9.6 g/litrepropoxurEmulsifiable concentrate containing1000 g/litre dichlorvosHSR000207 - BV2 Surface InsecticideHSR000209 - BV2 Surface Insecticide BulkHSR000211 P001132 NuvosDichlorvos reassessment – application Page 6 of 436

Aerosol containing 50 g/kgdichlorvosEmulsifiable concentrate containing1140 g/litre dichlorvosHSR000212- InsectigasP005877HSR000213 P006080 DivapJ72.03 [insecticide for export-only] HSR001757 - -ClassificationArmourCrop-InsecticideAs a result of the review of the hazard classifications as part of this reassessment, ERMANew Zealand proposes that dichlorvos and dichlorvos-containing substances are classified asdetailed in Table ES. 3.Table ES. 3Summary of the revised classifications for for dichlorvos and dichlorvoscontainingsubstances (shaded cells indicate changes to existing classifications).Hazard ClassDichlorvosReady touse liquidcontaining4.4 g/ldichlorvos& 9.6 g/lpropoxurHSR000209Emulsifiableconcentratecontaining1000 g/ldichlorvosAerosolcontaining50 g/kgdichlorvosEmulsifiableconcentratecontaining1140 g/ldichlorvosFlammableaerosolcontaining3.1 g/ldichlorvosand 8.7 g/lpropoxurHSR000207DDVPinsecticidestripHSRHSR HSR HSRHSRApproval #002838000211 000212 000213000126Flammability No No No No 2.1.2A No No NoJ72.03HSR001757Acute toxicityN/A,N/A,6.1B 6.1D 6.1C6.1C(oral)aerosolaerosol6.1D 6.1CAcute toxicity(dermal)6.1B 6.1E 6.1B 6.1D 6.1B No 6.1E 6.1CAcute toxicity(inhalation)6.1B No 6.1B 6.1C 6.1C No 6.1C 6.1BSkinirritancy/corrosion6.3B 6.3B 6.3B No 6.3B 6.3B 6.3B 6.3BEyeirritancy/corrosion6.4A 8.3A 6.4A No 6.4A 6.4A 6.4A 6.4AContactsensitisation6.5B 6.5B 6.5B 6.5B 6.5B 6.5B 6.5B 6.5BMutagenicity 6.6B No 6.6B 6.6B 6.6B ND 6.6B 6.6BCarcinogenicity 6.7B 6.7B 6.7B 6.7B 6.7B 6.7B 6.7B 6.7BReproductive/developmentalNo No 6.8A No ND ND ND NotoxicityTarget organsystemic toxicity6.9A 6.9B 6.9A 6.9B 6.9A 6.9B 6.9A 6.9AAquaticecotoxicity9.1A 9.1A 9.1A 9.1A 9.1A 9.1A 9.1A 9.1ASoil ecotoxicity 9.2D No 9.2D No 9.2D ND ND NDTerrestrial vert.ecotoxicity9.3A 9.3B 9.3A 9.3B 9.3A 9.3B 9.3B 9.3BTerrestrial invert.ecotoxicity9.4A 9.4B 9.4A 9.4A 9.4A 9.4B 9.4A 9.4ADichlorvos reassessment – application Page 7 of 436

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

This evaluation takes into account that ERMA New Zealand‘s assessment is based on theinformation that is available to it. Additional information is welcomed. ERMA New Zealandinvites submitters to provide additional information that they might have, and notes thefollowing as areas where additional information may be particularly useful:the level of benefit offered by dichlorvos substances, especially regarding socialeffects from the use of dichlorvos (e.g. effect on local employment opportunities,direct/indirect local community impact arising from dichlorvos use);the level of ecomonic benefit provided to the public health sector by dichlorvos;the financial implications of overseas restrictions on crops treated with dichlorvos;identification of the use and availability of alternative substances, with particularregard to dichlorvos use in non-agricultural enclosed space use;identification of use patterns that have not been included in the assessment;provision of data to determine when unrestricted entry into treated glasshouses ormushroom houses can occur;identification of minimum effective application rates, which may be used to refinethe exposure assessment;feasibility of proposed risk management measures, and the implications of themodified control regime (such as financial implications of installing or upgradingapplication equipment).ERMA New Zealand considers that:the non-negligible risks to the environment (Use Scenarios 1 to 8) cannot bereduced to negligible by the application of practicable controls to the existingapprovals, and that these adverse effects are not outweighed by the positiveeffects;the non-negligible risks to human health can be reduced to negligible for the UseScenarios 9 to 29, and 31 by the application of practicable controls;the non-negligible risks to human health cannot be reduced to negligible for UseScenario 30 by the application of practicable controls, and that these adverseeffects are not outweighed by the positive effects.ERMA New Zealand considers that the Outcome Scenarios in Table ES. 5 are appropriate forcontinued safe use of dichlorvos in New Zealand.Table ES. 5Summary of proposed Outcome Scenarios for use of dichlorvos.Use Scenarios Continue Use Restrict Use /Additional ControlsOutdoor agricultural usage1 - 8Enclosed space, agricultural usage9 - 16Enclosed space, industrial usage17 - 25Enclosed space, domestic usageOutcomeScenario (a)OutcomeScenario (b)DiscontinueUseOutcomeScenario (c)Dichlorvos reassessment – application Page 10 of 436

26 - 29Outdoor public space usage30Biosecurity use31Manufacture for export32Preliminary RecommendationsOn the basis of its evaluation of whether the risks associated with the use of dichlorvos inNew Zealand outweigh the benefits, ERMA New Zealand proposes the following preliminaryrecommendations to ensure that practices minimise the risk for people and the environment:Discontinue Use (Outcome Scenario (c)) for outdoor agricultural or public area uses.Continue Use (Outcome Scenario (a)) is proposed for dichlorvos (approval numberHSR002838).Continue Use (Outcome Scenario (a)) is proposed for J72.03 (approval number HSR001757).Restrict Use / Additional Controls (Outcome Scenario (b)) is proposed for the followingdichlorvos-containing substances:DDVP Insecticide Strip (approval number HSR000126);Flammable aerosol containing 3.1 g/litre dichlorvos and 8.7 g/litre propoxur(approval number HSR000207);Ready to use liquid containing 4.4 g/litre dichlorvos and 9.6 g/litre propoxur(approval number HSR000209);Emulsifiable concentrate containing 1000 g/litre dichlorvos (approval numberHSR000211);Aerosol containing 50 g/kg dichlorvos (approval number HSR000212);Emulsifiable concentrate containing 1140 g/litre dichlorvos (approval numberHSR000213).The proposed variations for these approvals are detailed in Table ES. 6.Table ES. 6Summary of the proposed variations for dichlorvos and dichlorvos-containingsubstances.Substance detailsHSR002838Dichlorvos[CAS #62-73-7]HSR000126DDVPInsecticide StripUse Scenario31HSR000207FlammableProposed variationsNo variations to existing conditions proposed.1. Use that is not in accordance with the label instructions is prohibited;2. Introduce PPE requirements for operators;3. Restrict the number of strips handled / traps serviced by operators per day;4. Labelling requirements to identify the inhalation risk;5. Provision of guidance material for transportation and use of DDVP Strips.1. Use that is not in accordance with the label instructions is prohibited;2. Restrict use to industrial sites and by commercial applicators only –Dichlorvos reassessment – application Page 11 of 436

Substance detailsaerosolcontaining 3.1g/litre dichlorvosand 8.7 g/litrepropoxurUse Scenarios26-27HSR000209Ready to useliquid containing4.4 g/litredichlorvos and9.6 g/litrepropoxurUse Scenarios28-29HSR000211Emulsifiableconcentratecontaining 1000g/litre dichlorvosUse Scenarios1-8,11-16,20-25,30HSR000212Aerosolcontaining 50g/kg dichlorvosUse Scenarios9-10, 17-19HSR000213Emulsifiableconcentratecontaining 1140g/litre dichlorvosUse ScenariosProposed variationsapproved handler exemption removed;3. Introduce PPE/RPE requirements;4. Application methods to be restricted to remote, automatic deliverysystems;5. Introduce maximum application rates and treatment areas;6. Introduce a restricted entry intervals;7. Introduce a maximum exposure time for entry into treated area.1. Use that is not in accordance with the label instructions is prohibited;2. Restrict use to industrial sites and by commercial applicators only –approved handler exemption removed;3. Introduce PPE/RPE requirements;4. Application methods to be restricted to remote, automatic deliverysystems;5. Introduce maximum application rates and treatment areas;6. Introduce a restricted entry intervals;7. Introduce a maximum exposure time for entry into treated area.1. Use that is not in accordance with the label instructions is prohibited;2. Outdoor agricultural or public area use is prohibited;3. Application methods to be restricted to remote, automatic deliverysystems, or limited manual hand-spraying;4. Apply a maximum quantity that an individual may mix/load per day;5. Introduce maximum application rates;6. Introduce PPE/RPE requirements;7. Introduce a restricted entry intervals;8. Introduce a maximum exposure time for entry into treated area.1. Use that is not in accordance with the label instructions is prohibited;2. Introduce PPE/RPE requirements for connection / disconnection ofcylinders, and entry into treated areas;3. Restrict number of cylinder changes per operator per day;4. Introduce maximum application rates;5. Introduce a maximum daily treatment volume per operator per day formanual application;6. Introduce a restricted entry intervals;7. Introduce a maximum exposure times for entry into treated area fordifferent tasks.1. Use that is not in accordance with the label instructions is prohibited;2. Outdoor agricultural or public area use is prohibited;3. Application methods to be restricted to remote, automatic deliverysystems, or limited manual hand-spraying;4. Apply a maximum quantity that an individual may mix/load per day;Dichlorvos reassessment – application Page 12 of 436

Substance details1-8,11-16,20-25,30HSR001757J72.03Use Scenarios32Proposed variations5. Introduce PPE/RPE requirements;6. Introduce maximum application rates;7. Introduce a restricted entry intervals;8. Introduce a maximum exposure time for entry into treated area.No variations to existing conditions proposed.ERMA New Zealand proposes that these recommendations are phased-in over a 12 monthperiod.ERMA New Zealand notes that the Authority must consider the costs and benefits of variedor additional controls, in accordance with clause 35 of the Methodology. If therecommendations from this assessment are adopted there may be additional costs required tousers arising from a need to upgrade existing or install new equipment in order to continue touse dichlorvos for certain uses. The net level of benefit may be reduced as a result. ERMANew Zealand invites submitters to provide information relating to the cost implications ofadopting the proposed recommendations.Finally, if the Authority‘s overall evaluation favours retention of some or all of the dichlorvosapprovals, ERMA New Zealand proposes the revised classifications for dichlorvos anddichlorvos-containing substances detailed in Table ES. 3.SubmissionsSubmissions are now invited on the appropriateness or workability of the aboverecommendations.Submissions on this application must be made within a 40 working day period. Electronicresponses using the form on our web site are encouraged. Please return your submission,whether electronic or by post, fax or email to:ERMA New ZealandPO Box 131WellingtonFax: 04 914 0433Email: reassessments@ermanz.govt.nzwww.ermanz.govt.nzAll submissions must be received by 5 pm, 18 February 2011.Submissions must state the reasons for making the submission and state whether the submitterwishes to be heard at a public hearing. The submission may also state any decision sought.For more information on the reassessment process seehttp://www.ermanz.govt.nz/hs/reassessment/index.html .Dichlorvos reassessment – application Page 13 of 436

SECTION 1 – THE APPLICATION1.1 Applicant details1.1.1 Name and address in New Zealand of the organisation making the applicationName:Chief ExecutiveERMA New ZealandPostal Address: P O Box 131Wellington 6140New ZealandPhysical address: Level 1BP House20 Customhouse QuayWellingtonNew ZealandPhone: +64-4-916 2426Fax: +64-4-914 04331.1.2 Name of the contact person for the applicationName:Position:Postal address:Matthew AllenAdvisor (Hazardous Substances)ERMA New ZealandPO Box 131Wellington 6140New ZealandPhone: 04 918 4803Email:matthew.allen@ermanz.govt.nz1.2 Background to the application1.2.1 This is an application for the reassessment of dichlorvos and formulations containingdichlorvos prepared by ERMA New Zealand under section 63 of the HazardousSubstances and New Organisms Act (‗the Act‘).1.2.2 Dichlorvos was placed on the Chief Executive‘s Reassessment (CEIR) Priority Listin 2007, taking into account:Dichlorvos has high acute toxicity via oral, dermal and inhalation routes andhas the potential to cause adverse effects to the nervous system in humans atlow concentrations.Dichlorvos is also very ecotoxic to aquatic organisms, birds and honeybees.The US imposed a series of new and more stringent measures to mitigate theresidential, occupational and ecological risks of dichlorvosSubmissions on the consultation of the proposed substances indicated thatdichlorvos should be on the CEIR priority list.Dichlorvos reassessment – application Page 14 of 436

1.2.3 In 2008, the Environmental Risk Management Authority (‗the Authority‘) consideredwhether or not there were grounds for reassessing the approvals for dichlorvos andformulations containing dichlorvos, under section 62 of the Act.1.2.4 The Authority decided that there were grounds for reassessment of dichlorvos and itsformulations, based on sections 62 of the Act, namely that: there is new informationfrom overseas regulatory authorities relating to the effects of dichlorvos and itsformulations and that, in light of this new information, reassessment of the substanceis warranted.1.2.5 The Authority considered that a reassessment of dichlorvos and its formulationsaligns well with ERMA New Zealand‘s risk reduction strategy, which seeks toreduce the risks New Zealanders may be exposed to via new organisms or hazardoussubstances.1.2.6 The decision that grounds for the reassessment of dichlorvos and its formulations hadbeen established was notified on 04 September 2008. In reaching its decision theAuthority noted the following:Formulations containing dichlorvos have been registered for use in NewZealand since 1968. Currently, four products are registered for agricultural usein New Zealand (ArmourCrop-Insecticide (DDVP), DDVP Insecticide Strip,Divap, Nuvos);Other dichlorvos-containing products are available: BV2 Surface Insecticide,BV2 Surface Insecticide Bulk, Insectigas;J72.03 is manufactured for export;Overseas regulatory action has led to the withdrawal/phasing out of dichlorvosin Europe (and certain products in North America), the adoption of morestringent measures for domestic and agricultural use in the USA and Canada,and a proposal for adoption of more stringent measures in Australia.The reassessment of dichlorvos and its formulations aligns with the principlesof the ERMA New Zealand Risk Reduction strategy.1.3 Preparation of the application1.3.1 In preparing this application, ERMA New Zealand sought information fromimporters and users regarding:use patterns including ‗off label‘ uses;benefits from the use of the substance in New Zealand; andlifecycle information.1.3.2 A full list of the parties contacted for this information is set out in Appendix M.1.3.3 In response to this pre-application consultation, information was received from:Adria Crop Protection (Len Stulich)Auckland Regional Council (Sandi Murray)BOCEcolab (Eric Van Essen)Environment Bay of Plenty (David Phizacklea)Environment Canterbury (Ron McCraw)Fonterra (Roger Andela)Dichlorvos reassessment – application Page 15 of 436

Foundation for Arable Research (Nick Pyke)Greater Wellington (Ray Clarey)Horticulture New ZealandMAF Biosecurity (Vivien Thompson)Meadow Mushrooms Ltd (Gill Hoglund)Northern Distributors (Les Bryant)Northland Cymbidium Grower‘s AssociationOrion Crop Protection (John Hicking)Rentokil (Jon Thompson)1.3.4 New Zealand Food Safety Authority (NZFSA) supplied a document (Appendix M)outlining the responsibilities of NZFSA under the various legislations relevant topesticide regulation.1.3.5 ERMA New Zealand also commissioned a report from Plant & Food Research(Appendix R) regarding:Horticultural use patterns including ‗off label‘ uses;benefits from the use of the substance in New Zealand;lifecycle information; andavailability of alternative pesticides.1.3.6 To the extent appropriate, ERMA New Zealand considered publicly availablesources of toxicology and environmental fate and effects test data.1.4 Notification and Consultation1.4.1 This application has been prepared by ERMA New Zealand and will be publiclynotified for submissions for a 40 working day period. The submissions received,together with the application, will be taken into account by the Authority inconsidering the reassessment. If required by any submitter, the Authority will hold apublic hearing.1.4.2 ERMA New Zealand also commissioned a report from Martin Edwards Consultingregarding:the toxicology of dichlorvos; andexposure of operators and bystanders.1.4.3 Substance(s) covered by the application1.4.4 Existing dichlorvos-containing substances for which there are HSNO approvals andwhich are therefore the subject of this reassessment, are shown in Table 1:Dichlorvos reassessment – application Page 16 of 436

Table 1. Dichlorvos-containing substances covered by this application 1 .Substance description Approval # Trade namesDichlorvos [CAS #62-73-7] HSR002838 No trade names for thisapproval.Aerosol containing 50 g/kg dichlorvos HSR000212 Insectigas / ArmourCrop-Insecticide*Emulsifiable concentrate containing1000 g/litre dichlorvosEmulsifiable concentrate containing1140 g/litre dichlorvosFlammable aerosol containing 3.1g/litre dichlorvos and 8.7 g/litrepropoxurReady to use liquid containing 4.4g/litre dichlorvos and 9.6 g/litrepropoxurDDVP Insecticide Strip [intended foruse in fly monitoring]HSR000211HSR000213HSR000207HSR000209HSR000126Nuvos*Divap*BV2 Surface InsecticideBV2 Surface InsecticideBulkDDVP Insecticide Strip*J72.03 [insecticide for export-only] HSR001757 No trade names for thisapproval.* Currently (22 November 2010) registered under the Agricultural Compounds and Veterinary Medicines (ACVM)Act. BV2 Surface Insecticides are only used in domestic settings and do not require ACVM registration.Dichlorvos reassessment – application Page 17 of 436

SECTION 2 - THE RISK MANAGEMENT CONTEXT2.1 Risk management context2.1.1 The Authority decides whether to approve or decline hazardous substances based onthe requirements of the HSNO Act and the Methodology 1 . The purpose of the Act isto ―protect the environment and the health and safety of people and communities, bypreventing or managing the adverse effects of hazardous substances and neworganisms‖. The Act and the Methodology therefore provide the foundation for therisk management context for the evaluation and review of this application whichmust be undertaken in accordance with the purpose of the Act.2.1.2 Section 29 of the Act requires the Authority to consider adverse and positive effectsof the substance(s) and to make a decision based on whether or not the positiveeffects of releasing the substance outweigh the adverse effects of the substance. Therelevant adverse and positive effects are those that are associated with the substance.2.1.3 In particular, in accordance with section 6 of the Act, the following matters havebeen taken into account in assessing the risks, costs and benefits associated with theuse of dichlorvos in New Zealand:The sustainability of native and valued introduced flora and fauna;The intrinsic value of ecosystems;Public health;The relationship of Māori and their culture and traditions with their ancestrallands, water, sites, wāhi tapu, valued flora and fauna, and other taonga;The economic and related benefits to be derived from the use of dichlorvos;New Zealand‘s international obligations.2.1.4 ERMA New Zealand notes that comparison of risks or benefits, for example a risk ofchronic human toxic effects compared to a risk of aquatic toxic effects, and thecomparison of risks and benefits, for example an environmental or human health riskcompared to a societal or economic benefit, requires value judgement. This is takeninto account in making recommendations (Section 7) and the Authority will take thisinto account in reaching an overall assessment of the risks and benefits.2.2 Consideration of Outcome Scenarios2.2.1 Risk-benefit analysis is used to assess the adverse and positive effects. Risk-benefitanalysis is a comparative tool; thus the results of the assessment of risks and benefitsfor one option need to be compared against one or more alternative options.2.2.2 In the HSNO context there are two basic options in terms of the resultant riskmanagement regimes to be applied to the approvals for substances containingdichlorvos: the baseline Outcome Scenario linked to the status quo and one or morealternative Outcome Scenarios. In this instance the baseline scenario is based on thecurrent use of the substance.2.2.3 Dichlorvos is used in a range of sectors. The sectors evaluated in this applicationare: dispersive use, greenhouse use, use on industrial premises, use in domestic and1Hazardous Substances and New Organisms (Methodology) Order 1998 (SR 1998/217).Dichlorvos reassessment – application Page 18 of 436

public environments and use for biosecurity purposes. For each sector use ofdichlorvos, ERMA New Zealand considered the following Outcome Scenarios:(a) The baseline scenario: continued use with the current controls;(b) Continued use with revised controls;(c) Prohibition of use.2.2.4 The assessment of effects is based on the difference between Outcome Scenario (b)and the baseline, and Outcome Scenario (c) and the baseline. The assessmentassumes that the existing controls will be complied with and thus the relevant risksare those that remain after the controls are taken into account.2.2.5 The first step in the reassessment is to determine whether or not there are anypotentially significant adverse effects. If the adverse effects are negligible, thenfurther analysis is not required (i.e. Outcome Scenario (a)). However, if there arepotentially significant adverse effects then additional controls may be applied toameliorate these adverse effects. The application of additional controls andrestrictions on the current use of dichlorvos is treated as a modification of thebaseline scenario (i.e. Outcome Scenario (b)). If no practical controls or restrictionscan adequately ameliorate these adverse effects, then that use may be prohibited (i.e.Outcome Scenario (c)).2.3 Identification and assessment process2.3.1 ERMA New Zealand identified the risks and benefits associated with the substanceand then undertook a scoping exercise to determine which of them are potentiallysignificant. Risks and benefits are identified in terms of the scenarios and thisrequires identifying the sources of effect (for example, the hazards and benefits), thepathways for exposure, the areas of impact, and the likelihood and magnitude ofeffect. In accordance with clauses 9 and 10 of the Methodology, and sections 5 and6 of the Act, the risks and benefits are characterised in relation to the following areasof impact: the environment, human health and safety, relationship of Māori to theenvironment, the market economy, and society and the community.2.3.2 The second step is to assess the risks and benefits that have been identified as beingpotentially significant. Those risks and benefits that are deemed to be not potentiallysignificant are described, but are not assessed in detail. Assessing risks and benefitsinvolves combining the magnitude (size or value) of an effect and the likelihood of itoccurring. Where there is uncertainty about the magnitude of the effect a range ofmagnitudes may be assessed.2.3.3 The estimation of magnitude and likelihood is conducted on a qualitative basisinformed where possible by quantitative estimates and analysis.2.3.4 The approach adopted in identifying and assessing risks and benefits (adverse andpositive effects) is as described in the ERMA New Zealand technical guides:Assessment of Effects of Hazardous Substances and New Organisms onHuman Health (ERMA New Zealand 2000);Decision Making: A Technical Guide to Identifying, Assessing and EvaluatingRisks, Costs and Benefits (ERMA New Zealand 2009); andAssessment of Economic Risks, Costs and Benefits: consideration of impactson the market economy (ERMA New Zealand 2005).Dichlorvos reassessment – application Page 19 of 436

2.3.5 Details of ERMA New Zealand‘s qualitative risk assessment methodology are set outin Appendix H.2.4 Consideration of uncertainty2.4.1 Clause 8 of the Hazardous Substances and New Organisms (Methodology) Order1998 (the Methodology) states that the information used by the Authority whenconsidering an application must be relevant and appropriate to the scale andsignificance of the risks, costs and benefits associated with the substance.2.4.2 Clause 29 of the Methodology indicates that when the Authority encounters scientificand technical uncertainty relating to the potential adverse effects of a substance, theAuthority must determine the materiality and significance to the application of theuncertainty. Where any scientific or technical uncertainty is not resolved, theAuthority must take into account the need for caution in managing the adverseeffects of the substance (clause 30).2.4.3 Where the Authority considers that there is uncertainty in relation to costs, benefits,and risks (including, where applicable, the scope for managing those risks), theAuthority must attempt to establish the range of uncertainty and must take intoaccount the probability of the costs, benefits and risks being either more or less thanthe levels presented in evidence (clause 32).2.5 Ethical considerations2.5.1 In reviewing the information provided and identifying and assessing the adverse andpositive effects of dichlorvos, ethical matters relevant to the use of dichlorvos havebeen taken into account. Guidance is provided by the ERMA New Zealand EthicsFramework Protocol. 2 This framework acknowledges that individuals andcommunities hold a range of ethical views. It has been developed as a tool to assistall participants in the ERMA New Zealand decision-making process to:ask the ‗right‘ questions in order to identify areas where there are ethicalmatters to be considered; anduse the answers to these questions to explore whether and how ethicalconsiderations need to be addressed.2.5.2 The foundation of the framework is a set of ethical principles, supported byprocedural standards. The two general principles, which are embodied in the HSNOAct and the Methodology, are:respect for the environment; andrespect for people (including past, present and future generations).2.5.3 Under these general principles is a set of specific principles expressed as concerns.These are concern for animal welfare, autonomy, co-operation, culturalidentity/pluralism, human rights, human dignity, justice and equality, sustainabilityand wellbeing/non-harm.2.5.4 The primary mechanisms for supporting the principles outlined in the framework andfor evaluating whether or not they are upheld are the procedural standards of honestyand integrity, transparency and openness, a sound methodology, community andexpert consultation and a fair decision-making process.2.5.5 In preparing this application ERMA New Zealand has applied the criteria in theprocedural standards listed above to its evaluation and review of all the information2December 2005, ER-PR-05-1 12/05.Dichlorvos reassessment – application Page 20 of 436

available to it. In preparing this application, ERMA New Zealand has beenconscious of the concerns expressed by parties who have supplied information toassist in the preparation of this application, and their beliefs that are the basis forthese concerns. When ethical dilemmas arise ERMA New Zealand has describedthem in terms of the framework.2.6 Principles of the Treaty of Waitangi (Te Tiriti ō Waitangi)2.6.1 Section 8 of the Act requires the Authority, when considering applications, to takeinto account the principles of the Treaty of Waitangi. Of particular relevance to thisapplication is the principle of active protection affirmed in 1987 by the Court ofAppeal in the Lands case.2.6.2 It refers to the Crown‘s obligation to take positive steps to ensure that Māori interestsare protected, and to consider them in line with the interests guaranteed to Māori inArticle II of the Treaty. Specifically the Court noted that ―… the duty of the Crown isnot merely passive but extends to active protection of Māori people in the use of theirlands and waters to the fullest extent practicable‖ (Cooke 1987).2.6.3 Taking into account the principle of active protection requires this application toprovide sufficient evidence to show that the use of dichlorvos poses no risk ofadverse effects to native/endemic species and/or other taonga species, ecosystemsand traditional Māori values, practices, health and well-being. In considering thelevel of uncertainty described in relation to the adverse effects noted above, ERMANew Zealand considers that this application may currently be viewed as beinginconsistent with the principle of active protection.Dichlorvos reassessment – application Page 21 of 436

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

dermal and inhalation exposure and by oral and inhalation repeat exposure. Primaryeffects are on cholinesterase activity (in the blood (plasma and red blood cells) andbrain), and as a result is neurotoxic.3.5.4 Dichlorvos in soil will degrade rapidly, primarily to desmethyldichlorvos anddichloroacetaldehyde, with some dichloroethanol and dichloracetic acid. Both parentand metabolites have half-lives generally

3.6 Classification3.6.1 The HSNO classifications of dichlorvos are shown in Table 3 and the classificationsof its formulations is shown in Table 4. The data on which these classifications arebased are shown in Appendices E & G. The data from which the classifications ofthe formulations has been derived is shown in the Confidential Appendix. Proposedchanges to the existing classifications are highlighted in shaded cells.Table 3.Hazard Class/SubclassClassification of dichlorvos.Dichlorvos classificationsExistingProposedClass 1 Explosiveness No NoClass 2, 3 & 4 Flammability No NoClass 5 Oxidisers/Organic Peroxides No NoSubclass 8.1 Metallic corrosiveness No NoSubclass 6.1 Acute toxicity (oral) 6.1B 6.1BSubclass 6.1Acute toxicity (dermal) 6.1B 6.1BSubclass 6.1 Acute toxicity (inhalation) 6.1A 6.1BSubclass 6.3/8.2 Skin irritancy/corrosion ND 6.3BSubclass 6.4/8.3 Eye irritancy/corrosion 6.4A 6.4ASubclass 6.5A Respiratory sensitisation ND NDSubclass 6.5B Contact sensitisation 6.5B 6.5BSubclass 6.6 Mutagenicity No 6.6BSubclass 6.7 Carcinogenicity 6.7B 6.7BSubclass 6.8 Reproductive/ developmentaltoxicitySubclass 6.9 Target organ systemic toxicity(oral: single, repeat)Subclass 6.9 Target organ systemic toxicity(dermal: single)Subclass 6.9 Target organ systemic toxicity(inhalation: single, repeat)NoNo6.9A 6.9A6.9B 6.9B6.9A 6.9ASubclass 9.1 Aquatic ecotoxicity 9.1A 9.1ASubclass 9.2 Soil ecotoxicity ND 9.2DSubclass 9.3 Terrestrial vertebrate ecotoxicity 9.3A 9.3ASubclass 9.4 Terrestrial invertebrate ecotoxicity 9.4A 9.4ADichlorvos reassessment – application Page 25 of 436

Table 4.Classification of dichlorvos-containing substances.Hazard Class /SubclassClassificationsReady to use liquidcontaining 4.4 g/ldichlorvos & 9.6 g/lpropoxurEmulsifiableconcentratecontaining 1000 g/ldichlorvosAerosol containing50 g/kg dichlorvosEmulsifiableconcentratecontaining 1140g/l dichlorvosFlammableaerosolcontaining 3.1 g/ldichlorvos and8.7 g/l propoxurDDVP insecticidestripJ72.03Existing Proposed Existing Proposed Existing Proposed Existing Proposed Existing Proposed Existing Proposed Existing ProposedClass 1ExplosivenessClass 2, 3 & 4FlammabilityClass 5Oxidisers/OrganicPeroxidesSubclass 8.1MetalliccorrosivenessSubclass 6.1Acute toxicity(oral)No No No No No No NoNo No No 2.1.2A No No NoNo No No No No No NoNo No No No No No No6.1D 6.1B 6.1C N/A, aerosol 6.1B 6.1C N/A, aerosol 6.1D* 6.1B 6.1CSubclass6.1Acutetoxicity(dermal)6.1E 6.1B N/A,aerosol6.1D 6.1B N/A,aerosolNo 6.1E* 6.1CDichlorvos reassessment – application Page 26 of 436

Hazard Class /SubclassClassificationsReady to use liquidcontaining 4.4 g/ldichlorvos & 9.6 g/lpropoxurEmulsifiableconcentratecontaining 1000 g/ldichlorvosAerosol containing50 g/kg dichlorvosEmulsifiableconcentratecontaining 1140g/l dichlorvosFlammableaerosolcontaining 3.1 g/ldichlorvos and8.7 g/l propoxurDDVP insecticidestripJ72.03Existing Proposed Existing Proposed Existing Proposed Existing Proposed Existing Proposed Existing Proposed Existing ProposedSubclass 6.1Acute toxicity(inhalation)Subclass 6.3/8.2Skin irritancy /corrosionSubclass 6.4/8.3Eye irritancy /corrosionSubclass 6.5ARespiratorysensitisationSubclass 6.5BContactsensitisationSubclass 6.6MutagenicitySubclass 6.7Carcinogenicity6.1D No 6.1A 6.1B 6.1B 6.1C 6.1A 6.1C 6.1D No 6.1B 6.1C 6.1A 6.1B6.3B ND 6.3B No 6.3B 6.3B No 6.3B ND 6.3B8.3A 6.4A No 6.4A 6.4A No 6.4A No 6.4AND ND ND ND ND ND ND6.5B 6.5B 6.5B 6.5B 6.5B 6.5B 6.5BNo ND 6.6B ND 6.6B 6.6B ND ND 6.6B ND 6.6B6.7B 6.7B 6.7B 6.7B 6.7B 6.7B 6.7BDichlorvos reassessment – application Page 27 of 436

Hazard Class /SubclassClassificationsReady to use liquidcontaining 4.4 g/ldichlorvos & 9.6 g/lpropoxurEmulsifiableconcentratecontaining 1000 g/ldichlorvosAerosol containing50 g/kg dichlorvosEmulsifiableconcentratecontaining 1140g/l dichlorvosFlammableaerosolcontaining 3.1 g/ldichlorvos and8.7 g/l propoxurDDVP insecticidestripJ72.03Existing Proposed Existing Proposed Existing Proposed Existing Proposed Existing Proposed Existing Proposed Existing ProposedSubclass 6.8Reproductive /developmentaltoxicitySubclass 6.9Target organsystemictoxicitySubclass 9.1AquaticecotoxicitySubclass 9.2Soil ecotoxicitySubclass 9.3TerrestrialvertebrateecotoxicitySubclass 9.4TerrestrialinvertebrateNo 6.8A No ND ND ND No6.9B 6.9A 6.9B 6.9A 6.9B 6.9A 6.9A9.1A 9.1A 9.1A 9.1A 9.1A 9.1A 9.1ANo ND 9.2D No ND 9.2D ND ND ND9.3B 9.3A 9.3B 9.3A ND 9.3B 9.3A 9.3B 9.3A 9.3B9.4C 9.4B 9.4A 9.4B 9.4A 9.4A 9.4C 9.4B 9.4A 9.4B 9.4ADichlorvos reassessment – application Page 28 of 436

Hazard Class /SubclassClassificationsReady to use liquidcontaining 4.4 g/ldichlorvos & 9.6 g/lpropoxurEmulsifiableconcentratecontaining 1000 g/ldichlorvosAerosol containing50 g/kg dichlorvosEmulsifiableconcentratecontaining 1140g/l dichlorvosFlammableaerosolcontaining 3.1 g/ldichlorvos and8.7 g/l propoxurDDVP insecticidestripJ72.03ecotoxicityNotes:* formulation test dataExisting Proposed Existing Proposed Existing Proposed Existing Proposed Existing Proposed Existing Proposed Existing ProposedChanges to classifications are due to:acute oral toxicity classification – use of different toxicity dataacute dermal toxicity classifications –dermal exposure to aerosol considered to be relevant.acute inhalation toxicity classification – previously interpreted best study as being vapour exposure, now assessed as aerosol exposureterrestrial vertebrate ecotoxicity classification – based on summation in accordance with current practice where previously used additivity to estimatetoxicity of mixturesterrestrial invertebrate ecotoxicity classification – use of different bee toxicity data.Dichlorvos reassessment – application Page 29 of 436

3.7 LifecycleManufacture, importation, transport and storage3.7.1 Dichlorvos is imported by sea in 200 l steel drums. It is not manufactured in NewZealand currently. Transport is under UN Number 3018, Transport Hazard Class6.1, Packaging Group I and products are marine pollutants under the IMDG Code.3.7.2 The EC formulation is manufactured in New Zealand and is also imported packagedready for sale. It is transported in 1 and 5 litre HDPE jerry cans (480 and 144 perpallet). Transport is under UN Number 3018, Transport Hazard Class 6.1, PackagingGroup Number I and products are marine pollutants under the IMDG Code.3.7.3 Dichlorvos is also imported and packaged into BV2 surface insecticide aerosols withtamper-proof closures. 250 kg dichlorvos is imported in drums by sea per 5 yearperiod. After packaging, the aerosols are transported on pallets of 1296 aerosols (L.Bryant pers. comm.).3.7.4 Dichlorvos is also imported and packaged into 50 g/kg gas cylinders. Insectigascylinders are either 6 kg or 36 kg, ArmourCrop (DDVP) are 6 kg or 31 kg. Cylindershave an AS 2473 Type 40 outlet connection and are transported up to 12 cylindersper pallet (S. Thalavaisundaram pers. comm.).3.7.5 DDVP Insecticide Strips are manufactured overseas and imported in plastic zip lockbags containing 50 hermetically sealed sachets per bag and five DDVP InsecticideStrips per sachet. DDVP Insecticide Strips are only imported by MAFBNZ and arerestricted by their HSNO Approval to use by that organisation. They are not for usein residential, commercial or industrial buildings, nor as an agricultural pesticide forpest control of infestations on animals such as pet collars.Use of Dichlorvos in New ZealandUse of dichlorvos as a plant protection product3.7.6 Use of dichlorvos as a plant protection product as described on the New Zealandlabels are detailed in Table 5:Table 5.Label rates and uses for dichlorvos-containing plant protectionproducts.Product Formulation type UsesArmourCrop-Insecticide(DDVP),/Aphidgas50 g/kg aerosol Greenhouse Usage:Capsicum – for control of aphidsRates:Fogging: 1 g / m 3 , 2.5 g / m 2(applied as a fog through a dosing systemdesigned and built by BOC Ltd for eachgreenhouse).Divap 1140 g/l EC Outdoor Crop Usage:Various outdoor cropsRates:Boomspray: up to 700 ml/ha;Mistblower: up to 90 ml / 100 litre water(no water rate per hectarespecified);maximum 3 applications at 7day intervals.Handgun:apply to runoff.Indoors Crop Usage:Glasshouses & mushroom housesDichlorvos reassessment – application Page 30 of 436

Rates:Fogging: 13 ml / litre (water) / 100 m 3 ;Spraying: 26 ml / 2 litre (water) / 100 m 2 .Nuvos 1000 g/l EC Outdoor Crop Usage:Various outdoor cropsRates:Boomspray: up to 800 ml/ha;Mistblower: up to 100 ml/100 litre water(no water rate per hectarespecified);maximum 3 applications at 7day intervals.Handgun: apply to runoff.Indoors Crop Usage:Glasshouses & mushroom housesRates:Fogging: 15 ml / litre (water) / 100 m 3 ;Spraying: 30 ml / 2 litre (water) / 100 m 2 .3.7.7 The following additional information relating to the use of dichlorvos on crops hasbeen acquired through discussion with users and manufacturers during thepreparation of this application.3.7.8 Insectigas from BOC is another 50 g/kg aerosol. It is not registered with ACVM foruse in greenhouses and this use is not on the label, but an information sheet 3 fromBOC does list use in greenhouses and gives a New Zealand contact address. Thisbrochure suggests application by 200 g spray into air space. Plant & Food(Appendix XXX) suggest that Insectigas cylinders may be connected to fixedpipework, or connected to hand-held spray guns or a release timer on top of thecylinder.3.7.9 Several users indicated that dichlorvos is used on an as-needed basis. HorticultureNew Zealand stated that dichlorvos is only used as needed which may be 1 year in 3for tamarillos, 1 year in 2 for glasshouses (tomatoes, capsicums, cucumbers), butmay also be used every year in glasshouses (capsicum) to break up use of Match(lufenuron) and Success (spinosad) which, used together, are the only other productsavailable to treat Western Flower Thrips.3.7.10 Adria (pers. comm.) stated that dichlorvos is only used in 40-50% of years (crop notspecified) i.e. approximately one in every two years. NCGA (2009) indicated that43% of the Cymbidium growers use dichlorvos every year as part of pest clean-upprogrammes, 30% treat only as needed, and approximately a third of growers do notuse it.3.7.11 One correspondent stated that dichlorvos EC tends to be used once, shortly beforeharvest and only if an insect problem is identified, its volatility making it ideal underthese conditions. At other times other pesticides are used (J. Hicking pers. comm.).Another importer said that dichlorvos EC may be used up to 3 times at 7 dayintervals, but also said that it tends to be used shortly pre-harvest (L. Stulich pers.comm.).3.7.12 Horticulture New Zealand stated that several other products used in greenhouses arenot compatible with IPM and that if dichlorvos was not available glasshouse growerswould use less IPM.3 https://boc.com.au/boc_sp/downloads/gas_brochures/BOC_Pestigas_Brochure.pdfDichlorvos reassessment – application Page 31 of 436

3.7.13 Dichlorvos is currently not used by New Zealand mushroom growers, on cereals orturf, although these are registered uses (Appendix N).3.7.14 In general, glasshouse growers use fogging equipment, only the smaller growersspray the crop. The reason is the availability of the equipment (Roelf Schreuder pers.comm.).Uses of dichlorvos other than as a plant protection product3.7.15 Dichlorvos formulations are put to uses other than for plant protection. Labeldescriptions of these uses are:Table 6.Label rates and uses for dichlorvos-containing products for non-plantprotection uses.Product Formulation type UsesDivap 1140 g/l EC Farm buildings:Farm buildings, empty stables, piggeriesand poultry housesRates (maximum):Fogging: 13 ml / litre / 100 m 3Spraying: 26 ml / 2 litre / 100 m 2 .Public health outdoors:Parks, beaches, sports areasRates:Fogging: 4 ml / litre.Fly breeding areasRates:Spraying: 13 ml/5 litre/10 m 2 .Public health Indoors:Hospitals, restaurants, canteens, cinemas,public halls, industrial plants, warehouses,food plantsRates:Fogging: 4, 9 or 13 ml / litre / 100 m 3depending on pestSpraying: 8, 18, or 26 ml / 2 litre / 100 m 2 .Nuvos 1000 g/l EC Farm buildings:Farm buildings, empty stables, piggeriesand poultry housesRates (maximum):Fogging: 15 ml / litre / 100 m 3Spraying: 30 ml / 2 litre / 100 m 2 .Public health outdoors:Parks, beaches, sports areasRates:Fogging: 5 ml / litre.Fly breeding areasRates:Spraying: 15 ml/5 litre/10 m 2 .Public health Indoors:Hospitals, restaurants, canteens, cinemas,Dichlorvos reassessment – application Page 32 of 436

BV2 SurfaceInsecticideBV2 SurfaceInsecticide Bulk3.1 g/l aerosol (dualactive with propoxur at8.7 g/l)4.4 g/l dichlorvosready-to-use liquid,(dual active with 9.6g/l propoxur).public halls, industrial plants, warehouses,food plantsRates:Fogging: 5, 10 or 15 ml / litre / 100 m 3depending on pestSpraying: 10, 20, or 30 ml / 2 litre / 100 m 2 .Surface treatmentskirting boards, library shelves, architravesetc.Rate:Spray affected areas until damp.Surface treatmentskirting boards, library shelves, architravesetc.Rate:Spray affected areas until damp.Insectigas 50 g/kg aerosol Spray treatmentRate:Spraying:100 g / 100 m 3 (18 s spray into air);300 g / 100 m 3 (54 s spray into cracks &crevices);200 g / 300 m 3 (70 s spray into air orcrevice).DDVP InsecticideStripJ72.03 ismanufactured forexport180 g/kg vapourreleasing strip5-24% dichlorvos, gascylindersUsed in fruit fly traps for fruit flymonitoring by MAF-BNZ.Export only3.7.16 The following additional information has been acquired through discussions withusers and manufacturers during the preparation of this application.3.7.17 Nuvos and Divap have treatment of grain moths, flour beetles, grain weevils andflour mites pests on the label, but listed against industrial plants, warehouses andfood plants. It is therefore unclear whether the NZ label supports treatment of grainor just the buildings used to store grain. Grain is treated overseas but it is not knownif this is done in NZ (Appendix K).3.7.18 About 25,000 cans of BV2 Surface Insecticide each containing 600 ml product areused per year. A maximum of two applications are made 2 weeks apart and 6 weeksof protection should result. (L. Bryant pers. comm.).3.7.19 Four or five glass jars of BV2 surface insecticide bulk each containing 4 litre productare used per year (L. Bryant pers. comm.).3.7.20 The application for dichlorvos strips to use in the fruit fly surveillance programme,said that up to 50,000 strips would be imported per year. In the current programmefewer strips are actually used. They are used all over NZ but in different densities.Single strips are contained within traps that also contain fruit fly lures. The strips arereplaced at 6-8 week intervals.Dichlorvos reassessment – application Page 33 of 436

3.8 Use Scenarios3.8.1 To evaluate the exposure risks to human health or the environment from use ofdichlorvos in agricultural and non-agricultural situations. a suite of Use Scenarioswere developed.3.8.2 Agricultural Use Scenarios are based on label rates, information from the Plant &Food use survey (Appendix N) and the above personnel communication (Table 7).Dichlorvos reassessment – application Page 34 of 436

Table 7.Dichlorvos outdoor and indoor plant protection Use Scenarios.UseScenarioOutdoorCrop/Use Method Rate Applications Basis for scenarioEquipment Details FormulationtypeApplicationrateArea orvolumetreatedNo.peryearInterval(days)Application rateArea or volumetreated1 Strawberries Low boom Fine – EC 800 20 ha 1 - Nuvos label. Other crops may use slightlymediumg a.i./halower rates e.g. cereals 750 g a.i./ha2 droplet2 7BBA model3 Vegetables, High boom Fine – EC 800 20 ha 1 -cereals,mediumg a.i./ha4 berriesdroplet2 75 Fruitairblast Finemediumg a.i./ha(Appendix K gives 2000 l/ha for persimmon,EC 2052 8 ha 1 - Divap label gives 90 ml/100 L. Plant & Food(tamarillo/6 persimmons/droplet2 7 giving 2052 g a.i/ha for Divap. Other crops mayberry)use lower water rates e.g. max of 900 l/ha fortamarillo (Horticulture New Zealand pers.comm.).BBA model7 Passionfruit knapsack Finemediumg a.i./haEC 1026 1 ha 1 - Divap label BBA model8 droplet2 7Indoorfog RTU gas 0.05 31250 m 39 Glasshouse Automatic1 - Armourcrop and Nuvos labels.crops/ application a g/m 3 (1.25 ha, 2.5Application frequency may be more frequent10mushroomsm high2 7than in Scenario 10 (3-5 times/yr for capsicum,11 EC glasshouse) 1 - Horticulture New Zealand pers. comm.). butgiven the rapid dissipation, frequency of12 2 7exposure has no effect on the risk (Appendix G).Nuvos label says may be applied as a lightspray, but Plant & Food (2009) indicate it isonly fogged. See too, Scenarios 15 & 16.R. Schreuder(pers. comm.)Dichlorvos reassessment – application Page 35 of 436

UseScenarioCrop/Use Method Rate Applications Basis for scenarioEquipment Details FormulationtypeApplicationrateArea orvolumetreatedNo.peryearInterval(days)Application rateArea or volumetreated13 Glasshouse Automatic fog/low EC 0.05 g/m 3 0.1 ha 1 - NCGO pers. comm.. NCGO pers.flowers application volumecomm..14 (cymbidium)mister2 715 Hand held Finemediumg a.i./haEC 1800 0.2 ha 1 -sprayer16 droplet2 7a Automatic application equipment assumes remote application (i.e. applicators not in the space being treated), so that occupational exposure is confined to mixer/loader, or in the case ofgas products, connecting/disconnecting cylinders;3.8.3 Non-agricultural usage of dichlorvos has been assessed based on the Use Scenarios identified in Table 8. These Use Scenarios were developedbased on label information, communication from users, registrants and manufacturers.Table 8.Dichlorvos non-agricultural Use Scenarios.Scenario Crop/Use Method Rate Applications Basis for scenarioEquipment Details FormulationApplicationrateArea orvolumetreatedNo.peryearInterval(days)Application rateArea or volumetreatedIndoor17 Enclosed Automatic fog RT U 0.05 & 0.15 375, 3750 1 - Armourcrop label APVMA (XXX)space applicationgas g a.i./ m 3 & 1250018 (industrial)m 3 ) 2 719 ManualfoggerfogRT Ugas1 -2 7Dichlorvos reassessment – application Page 36 of 436

Scenario Crop/Use Method Rate Applications Basis for scenarioEquipment Details FormulationApplicationrateArea orvolumetreatedNo.peryearInterval(days)Application rateArea or volumetreated20 Automatic fog EC 1 -application21 2 722 Manual fog EC 1 -fogger23 2 724 High Fine- EC 0.1 & 0.31 - Nuvos label ???pressure mediumg a.i./ m 225 hand-wand droplet2 7orequivalent26 Domestic use RTU3.1 1 x 600 ml1 - Internal assessment of worst case use Internalaerosolg ai/L canassessment of27 2 7worst case use28 knapsack Finemediumliquidassessment ofRTU 4 L 60 m 2 1 - Internal assessment of worst case use Internal29 droplet2 7worst case useOutdoor – public space30 Publicoutdoor useManualfoggerOutdoor – Biosecurity use of DDVP Insecticide StripFog EC 1000 ga.i./ha1 ha 1 - Nuvos label Internalassessment ofworst case use31 See description belowOther – manufacture for export32 No use details required for this Use ScenarioDichlorvos reassessment – application Page 37 of 436

3.8.4 In the application for the DDVP Insecticide Strip (Use Scenario 31 - HSR04011), itwas stated:“MAF have a specification for the surveillance for fruit flies including the fieldoperation of traps. The contractor must comply with this specification. Appendix A,Section 6. Fruit fly traps are usually set up from late August in northern NewZealand and later in the year further south as the temperatures increase. The trapsremain in place until June of the following year. The trap is a plastic containertypically 85 mm in diameter at base, 105 mm diameter at top and 100 mm deep. Theremovable lid is 110 mm in diameter. The base of the trap has four small drainageholes (2.5mm diameter) directly below the fruit fly entry holes. The four fruit flyentry holes are located 15 mm below the lip of the trap; these holes are 25 mm indiameter. Appendix A, Section 6 The lure traps contain one of three synthetic maleattractants. The choice of lure is specific to a species of fruit fly. The DDVPINSECTICIDE STRIP is positioned below the lure in the bottom of the trap. Thetraps are recommended to be placed either 400 or 1200 metres apart (one to 6.25traps per km 2 ) depending on the type of lure. The traps are placed in potential hostplants, ideally well foliaged and trees bearing fruit. Most importantly traps are nothung below foliage and no closer than 1.3 metres to the ground. If there is more thanone trap on a property then these are not placed in the same tree and must be at least3 metres apart. The property owner / occupier receives a letter and is briefed on thematerial used in the traps and is requested to report any interference or damage tothe trap to a freephone number operated by the contractor. Appendix 9. Each trap isinspected two weekly and the DDVP INSECTICIDE STRIP is replaced 6-weekly.Replacement of the lure is 6 or 12-weekly depending on the type of lure. Proceduresare followed to ensure lures are not mixed and that there is no contamination oftraps nor of the area around the trap. In the event of a trap being blown from thehost tree then the DDVP INSECTICIDE STRIP must be recovered and disposed ofsafely. The contractor is required to wear gloves and to use tweezers when handlingthe lures or DDVP INSECTICIDE STRIP. Traps are replaced if damaged orautomatically at the end of each season.”“ The trap operators setting up the fruit fly trapping stations are not expected tohave > 10 kg DDVP INSECTICIDE STRIPS (equivalent to 800 sachets) under theircontrol at any time. The largest trap run in Auckland comprises 45 traps, thereforethe season’s total requirement for this single run is 315 strips. Auckland runs areserviced from the Agriquality laboratory at Lynfield, and while an operator mayservice up to one and a half runs on a day (weather constraints) the maximumnumber of strips and operator would have in a vehicle at one time is about 90 (

humidity conditions. The higher residual concentration in the strip being replacedmeans that greater care is needed in handling the strip during replacement in thetrap and with the disposal of the used strips.Potential exposure of contractors carrying opened sachets might arise in a vehicle(confined space). However contractors are trained to roll over the torn opening toreseal the sachet. This not only protects from potential exposure by inhalation butalso helps ensure unused strips do not become prematurely depleted of the activecomponent.“3.8.5 On the basis of this information a Use Scenario for operator exposure was developedas follows. The operator will service 90 traps in a day, spending 2 minutes at eachtrap, giving an exposure of 3 hours per day. 41% of the 520 mg dichlorvos on a stripwill be emitted continuously over the 6 week (1008 hours) service life of a strip in atrap, giving an emission rate of 0.21 mg dichlorvos / hour. There will be no build-upof dichlorvos within a trap and an operator will inhale all the dichlorvos beingemitted from a trap as they bend over it to service it, but will not be exposed to anydichlorvos while travelling between traps, i.e. operators will be exposed to 0.21 mgdichlorvos / hour for 3 hours per day. The risks posed to operators based on thesefigures are detailed in paragraph 4.4.4.1.3.9 Existing Controls3.9.1 The lifecycle and hazardous properties of dichlorvos and its formulations aremanaged through a variety of controls. These controls are prescribed as part of theapproval of these substances under the Act and the Agricultural Compounds andVeterinary Medicines Act 1997 (ACVM Act), and through requirements for resourceconsents under the Resource Management Act 1991.3.9.2 The HSNO Act controls applicable to dichlorvos and its formulations are given inAppendix J. A summary of conditions under the ACVM Act is also given inAppendix J.3.9.3 In Section 4, the risks, costs and benefits of dichlorvos are identified and assessed.This assessment is made under the assumption that there is compliance with theexisting controls.Dichlorvos reassessment – application Page 39 of 436

SECTION 4 – IDENTIFICATION AND ASSESSMENT OFADVERSE AND BENEFICIAL EFFECTS (RISKS, COSTS ANDBENEFITS)4.1 Introduction4.1.1 The potential sources of risk to human health and to the environment are tabulated inTable 9.Table 9.Identification of potential sources of risk.Lifecycle ActivityFormulation &packagingLocal transportStorageUseDisposalAssociated Source of RiskAn incident during formulation or packagingTransport or handling incident on roads or during loading/unloadingresulting in spillage and subsequent exposure of people and/or theenvironmentIncident during storage, resulting in spillage and subsequent exposure ofpeople and/or the environmentExposure to users, bystanders and/or the environment during dilution,mixing or changing of cylinders or use, or through exposure to residues ontreated vegetation, soil, feed items.Disposal of the substance or containers, resulting in release of thesubstance and subsequent exposure of people and/or the environment4.2 IncidentsNew Zealand Incidents4.2.1 ERMA New Zealand notes the absence of relevant incident information relating tothe use of dichlorvos in New Zealand. This could be due either to a lack of incidentsor a lack of reporting/ monitoring.Overseas Reports4.2.2 USEPA (2006) discusses human incident data collected from the AmericanAssociation of Poison Control Centres. Although a large number (21006) ofexposures were reported, most involved homeowner products containing dichlorvosin association with other pesticides. The few reports involving dichlorvos alone,‗usually do not involve any significant acute symptoms that would require medicaltreatment‘. USEPA (2006) also discusses epidemiological studies examiningincreased incidence of childhood cancer and prostate cancer from exposure todichlorvos and concludes that confounding factors in the study design could explainany effects seen.4.2.3 USEPA (2006) also discusses environmental incident data reported from 1991 to2002 and concludes that the incident reporting system is inadequate to pick upwhether effects are occurring or not.4.2.4 APVMA do not include reporting of incidents in their draft review of dichlorvos(APVMA, 2008).Dichlorvos reassessment – application Page 40 of 436

4.3 EnvironmentIdentification of adverse effects (risks and costs)4.3.1 At all steps in the lifecycle (Table 9) there is potential for dichlorvos to enter theenvironment.4.3.2 Dichlorvos is very toxic to aquatic life, terrestrial vertebrates and terrestrialinvertebrates and harmful to soil organisms. Exposure of the environment couldtherefore result in significant effects.Assessment of potentially significant adverse effects (risks and costs)4.3.3 ERMA New Zealand assesses the significance of adverse effects by comparing theenvironmental exposure with existing controls in place to the concentration causingeffects.4.3.4 Given the default controls, any incidents would be likely to be localised and could beof no more than moderate magnitude if waterways became contaminated bysignificant quantities of dichlorvos. The likelihood of such effects resulting fromincidents/spills during repackaging, local transport, storage or disposal of dichlorvosproducts is considered to be highly improbable. This combination of likelihood andmagnitude indicates suggests a negligible risk 4 .4.3.5 The environmental effects that may arise from outdoor public health use (UseScenario 30) would be localised in extent and duration and therefore would beconsidered moderate in magnitude. ERMA New Zealand considers the likelihood ofmoderate effects to be unlikely, given the comparatively small areas that would betreated and the rapid dissipation of dichlorvos. This combination of likelihood andmagnitude also suggests a low risk.4.3.6 ERMA New Zealand considers that tthe magnitude of effects to the environment thatmay arise from dichlorvos use in biosecurity fruit fly monitoring traps (Use Scenario31) are minimal. The likelihood of environmental effects resulting from isconsidered highly improbable given the enclosed nature of the traps and thespecificity of the lures that attract pests to them. This combination of likelihood andmagnitude suggests a negligible risk.4.3.7 ERMA New Zealand modelled likely exposure during the use of dichlorvosaccording to the scenarios in Table 7. In determining exposure, ERMA NewZealand made no allowance for buffer zones around fields. L. Stulich (pers. comm.)indicated that 5 - 10 m hedging buffer zones are used, Horticulture New Zealandsuggested 4-6 m shelter belts are used for tamarillos, but ERMA New Zealand doesnot know if this is standard practice.4.3.8 Details of the environmental exposure modelling are presented in Appendix C.4The ERMA New Zealand qualitative risk matrix based on evaluation of likelihood and magnitude of risk isgiven in Appendix JDichlorvos reassessment – application Page 41 of 436

4.3.9 The conclusions of this risk assessment are:4.3.9.1 Aquatic environment – surface water:Fish:- the level of risk to fish from any of the outdoor Use Scenarios(1 to 8) is not significant, as indicated by risk quotients

4.3.9.3 Aquatic environment - Groundwater:Tier 0 modelling of concentrations in groundwater predictsconcentrations from 0.00069 to 0.0036 µg/L.Such concentrations are unlikely to be significant.4.3.9.4 Aquatic environment - Marine:No marine assessment was made;Given the fate of dichlorvos, adverse effects to the marineenvironment are considered unlikely.4.3.9.5 Terrestrial environment – birds:All plant protection Use Scenarios (1 - 8) give rise to exposure ofbirds through consumption of crops or invertebrates to whichdichlorvos was applied, and indicates a significant, non-negligiblerisk;There is significant uncertainty about this conclusion since theacute oral toxicity data, that are used in the analysis, indicate LD 50values (expressed in mg/kg bw/d) more than 100 times lower thanthe LC 50 values defined in the dietary toxicity studies (expressed inppm or mg/kg feed). A factor of 10x is normally expected (EFSA,2008), and likely reflects rapid dissipation of dichlorvos from food;LD 50 values are used in risk assessment due to difficulties indetermining how much food is eaten in dietary studies. However,given that the dietary route of exposure is the route by which birdsare exposed in the field and, given the rapid dissipation ofdichlorvos, the dietary data should also be considered. If this isdone, the risk quotients may be presumed to be overestimated quiteprobably by a factor of 10 which will reduce the risk to around thelevel of concern.4.3.9.6 Terrestrial – soil-dwelling invertebrates:Plant protection Use Scenarios (1 to 4, 7 to 8) give rise toinsignificant exposure of soil-dwelling invertebrates: the risks areassessed as being low outside the application area and also withinthe application area;Use Scenarios 5 and 6 (airblast application) gives rise to significant,non-negligible risk of exposure. The details of the earthwormtoxicity study on which this conclusion is reached are not available,but it is likely that dichlorvos was dosed to the test system withoutrenewal, therefore the exposure in the test and under fieldconditions would be similar;Consequently, these conclusions are reached with low uncertainty.Dichlorvos reassessment – application Page 43 of 436

4.3.9.7 Terrestrial – non-target invertebrates:The risks to bees are concluded to be very high from Use Scenarios1 to 8;This conclusion is based on a Tier 0 model in which applicationrate is related to bee toxicity. This model has been ‗validated‘against field observations of effects;Results of other trials are equivocal. APVMA (2008) mention theresults of a foliar residue study in which the LD 50 was reported tobe 0.2 kg ai/ha, which is less than New Zealand application rates,but no other information was available. By contrast, US EPA(2006) report the results of a study on the toxicity of foliar residuesto honey bees and showed residues of dichlorvos applied at 0.5 lbai/A (= 0.56 kg ai/ha) were practically nontoxic to honey bees threehours post treatment;Limited data on effects on other non-target invertebrates indicaterisks at field application rates.4.3.9.8 Terrestrial – plants:No data were identified to evaluate the effects of dichlorvos on plantseither through foliar or soil exposure.4.3.9.9 Bioconcentration:On the basis of low log K ow , dichlorvos will not bioconcentrate.4.3.10 Very little environmental exposure is expected from dichlorvos usage in indoorlocations, such as greenhouses (Use Scenarios 9 to 16), given that the substance isnot applied in a wide-dispersive manner that could expose the aquatic or terrestrialenvironments, and that dichlorvos is rapidly dissipated. This risk has not beenconsidered further.4.3.11 ERMA New Zealand expects that domestic use and non-agricultural enclosed spaceusage (Use Scenarios 17 to 29) will not give rise to any significant risk to the aquaticor terrestrial environments. This risk has not been considered further.Identification of beneficial effects (benefits)4.3.12 ERMA New Zealand did not identify any beneficial effects on the environment fromthe use of dichlorvos.4.4 Human health and safetyIdentification of adverse effects (risks and costs)4.4.1 Each of the lifecycle activities listed in Table 9 has the potential to expose people todichlorvos.Assessment of potentially significant adverse effects (risks and costs)4.4.2 Given the default controls, any incidents would be likely to be localised but could beof minimal to major magnitude. The likelihood of effects resulting fromincidents/spills during manufacture, repackaging, local transport, storage or disposalDichlorvos reassessment – application Page 44 of 436

is considered to be highly improbable. This combination of likelihood andmagnitude suggests a negligible to low risk. 54.4.3 ERMA New Zealand modelled likely exposure of people during use of dichlorvosfor the Use Scenarios for which appropriate modelling techniques exist. Details ofthe human exposure modelling are presented in Appendix G. These quantitativeestimates of exposure are related to concentrations calculated to cause effects toderive risk quotients. Given the complexity of the overall use pattern of dichlorvoscontainingsubstances, ERMA New Zealand has extracted the risk quotient data andprovided a summary plot as part of Appendix G to accompany the complete humanhealth exposure report.4.4.4 The conclusions of this risk assessment are:4.4.4.1 Operators:Although exposure to dichlorvos has potential to cause majorhealth effects, ERMA New Zealand considers that, given therequirements for packaging, transportation, storage, and the skilllevels of those persons involved in these stages of the lifecycles ofdichlorvos-containing products, ERMA New Zealand considers thatit is sufficiently unlikely that such adverse effects could occur.Additionally, ERMA New Zealand considers that it is highlyimprobable that even moderate adverse effects could occur.ERMA New Zealand has summarised and reviewed the riskquotients (RQs) calculated for the various Use Scenarios. Due tothe variety of Use Scenarios for dichlorvos-containingformulations, the Use Scenarios have been grouped, based on thecalculated RQ values. Certain Use Scenarios have been evaluatedwith a variety of operating conditions (e.g. using multiple 7Lcylinders vs. a single 35L cylinder), and due to those conditionsmay feature in several Risk Groups. In this event, only the lowestrisk group (and its associated conditions) for a particular UseScenario is identified. Also detailed in Table 10 are the conditionsupon which the Risk Quotient in question was determined.Where exposures have been determined to be negligible only whencertain conditions are adhered to, ERMA New Zealand considersthat those risks are non-negligible unless those conditions arespecified and implemented.5The ERMA New Zealand qualitative risk matrix based on evaluation of likelihood and magnitude of risk isgiven in Appendix J.Dichlorvos reassessment – application Page 45 of 436

Table 10.Summary of occupational risk quotients for the Use Scenarios of dichlorvos usage.RiskGroupRQ range Level of risk UseScenariosConditionsComments1 0 < RQ ≤ 1 Negligible 9 No cylinder changes, using35L cylinders.Automated application. Exposure occurs at connection anddisconnection of cylinders.Specific PPE requirements.10 No cylinder changes.Specific PPE requirements.Automated application. Exposure occurs at connection anddisconnection of cylinders.13 Specific PPE requirements. Automated application. Exposure occurs during mixingand loading.14 Specific PPE requirements. Automated application. Exposure occurs during mixingand loading.17 Up to 1 cylinder change peroperator per day.Automated application. Exposure occurs at connection anddisconnection of cylinders.Specific PPE requirements.18 Up to 1 cylinder change peroperator per day.Automated application. Exposure occurs at connection anddisconnection of cylinders.Specific PPE requirements.19 Specific PPE requirements.Maximum treated arearestriction.Manual application. Exposure occurs during mixing,loading and application.Dichlorvos reassessment – application Page 46 of 436

RiskGroupRQ range Level of risk UseScenariosConditionsComments20 Specific PPE requirements.Maximum quantity formixing restriction.21 Specific PPE requirements.Maximum quantity formixing restriction.22 Specific PPE requirements.Maximum quantity formixing and applicationrestriction.23 Specific PPE requirements.Maximum quantity formixing and applicationrestriction.24 Specific PPE requirements.Maximum quantity formixing, application andtreated area restriction.25 Specific PPE requirements.Maximum quantity formixing, application andAutomated application. Exposure occurs during mixingand loading.Automated application. Exposure occurs during mixingand loading.Manual application. Exposure occurs during mixing,loading and application.Manual application. Exposure occurs during mixing,loading and application.Manual application. Exposure occurs during mixing,loading and application.Manual application. Exposure occurs during mixing,loading and application.Dichlorvos reassessment – application Page 47 of 436

RiskGroupRQ range Level of risk UseScenariosConditionsCommentstreated area restriction.2 1 < RQ ≤ 10 Non-negligible 1 Specific PPE requirements. Manual application. Exposure occurs during mixing,loading and application.It may be possible to reduce the level of risk tolevels through use of additional controls (i.e.more restricted use parameters in comparisonto those used to determine the RQ values), suchthat the level of benefit outweighs the level ofrisk.2 Specific PPE requirements. Manual application. Exposure occurs during mixing,loading and application.3 Specific PPE requirements. Manual application. Exposure occurs during mixing,loading and application.4 Specific PPE requirements. Manual application. Exposure occurs during mixing,loading and application.11 Specific PPE requirements. Automated application. Exposure occurs during mixingand loading.12 Specific PPE requirements. Automated application. Exposure occurs during mixingand loading.15 Specific PPE requirements. Manual application. Exposure occurs during mixing,loading and application.16 Specific PPE requirements. Manual application. Exposure occurs during mixing,loading and application.26 No PPE specified. Domestic use product – assumed that no PPE would beused. Exposure occurs during application.27 No PPE specified. Domestic use product – assumed that no PPE would beused. Exposure occurs during application.Dichlorvos reassessment – application Page 48 of 436

RiskGroupRQ range Level of risk UseScenariosConditionsComments30 Specific PPE requirements. Manual application. Exposure occurs during mixing,loading and application.3 10 < RQ < ∞ Non-negligible(high)It is not likely to be possible to reduce the levelof risk to acceptable levels through use ofadditional controls.5 Max. PPE used inmodelling.6 Max. PPE used inmodelling.7 Max. PPE used inmodelling.8 Max. PPE used inmodelling.Manual application. Exposure occurs during mixing,loading and application.Manual application. Exposure occurs during mixing,loading and application.Manual application. Exposure occurs during mixing,loading and application.Manual application. Exposure occurs during mixing,loading and application.28 No PPE specified. Domestic use product – assumed that no PPE would beused. Exposure occurs during application.29 No PPE specified. Domestic use product – assumed that no PPE would beused. Exposure occurs during application.Dichlorvos reassessment – application Page 49 of 436

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

Table 11.Summary of Restricted Entry Intervals (REI) and restrictions for use of dichlorvos-containing substances.Level of Risk Use Scenario PPE/RPE requirements REI ConditionsNegligible0 < RQ < 13, 4 hood/visor + overalls over long-sleeved shirt and longleggedtrousers + boots + gloves; at least a half-facerespirator (minimum specification A1P2)Cereals scouting.9, 10, 11, 12 hood/visor + overalls over long-sleeved shirt and longleggedtrousers + boots + gloves; full-face respirator(minimum specification A1P2) or air-hosehood/visor + overalls over long-sleeved shirt and longleggedtrousers + boots + gloveshat/goggles + overalls over long-sleeved shirt and longleggedtrousers + boots + gloves13, 14 hood/visor + overalls over long-sleeved shirt and longleggedtrousers + boots + gloves; full-face respirator(minimum specification A1P2) or air-hosehat/goggles + overalls over long-sleeved shirt and longleggedtrousers + boots + glovesRestricted entry is permittedafter at least 4 hours haselapsed since completion ofapplication.Restricted entry is permittedafter at least 4 hours haselapsed since commencementof ventilation.Restricted entry is permittedafter at least 48 hours haselapsed since completion ofapplication.Restricted entry is permittedafter at least 72 hours haselapsed since completion ofapplication.Restricted entry is permittedafter at least 4 hours haselapsed since completion ofapplication.Restricted entry is permittedafter at least 4 hours haselapsed since commencementof ventilation.for ventilation.< 30 minutes exposure.for tending.< 2h / day.for any tasks in mushroomhouses.< 2h / day.for tending and harvesting ofglasshouse crops;for any tasks in mushroomhouses.for ventilation.< 30 minutes exposure.for tending/harvesting.< 1h / day.Dichlorvos reassessment – application Page 52 of 436

Nonnegligible1 < RQ < 10Nonnegligible(High)10 < RQ < ∞15, 16 hood/visor + overalls over long-sleeved shirt and longleggedtrousers + boots + gloves17, 18, 19, 20, 21,22, 23, 24, 25at least a half-face respirator (minimum specificationA1P2)no PPE or RPE requiredRestricted entry is permittedafter at least 72 hours haselapsed since completion ofapplication.Restricted entry is permittedafter at least 4 hours haselapsed since commencementof ventilation.Restricted entry is permittedafter at least 72 hours haselapsed since completion ofapplication.Entry permitted after 10 hourshas elapsed since completionof application.Entry permitted after 72 hoursafter commencement ofventilation for buildingstreated at 50 mg / m 3 .Entry permitted after 120hours after commencement ofventilation for buildingstreated at 150 mg / m 3 .for glasshouse tasks.for ventilation.< 30 minutes exposure.for tending and harvesting ofglasshouse crops.for ventilation.< 30 minutes exposure.1, 2 HIGH RISK EVEN WITH HIGHEST LEVEL OF PPE3, 4 HIGH RISK EVEN WITH HIGHEST LEVEL OF PPE Vegetables, berries5, 6, 7, 8 HIGH RISK EVEN WITH HIGHEST LEVEL OF PPE26, 27, 28, 29, 30 Very high risk (no PPE). assumes no dissipation.Dichlorvos reassessment – application Page 53 of 436

4.4.4.3 Bystanders and children:The risks to bystanders (including children) from Use Scenarios 1to 8 are considered to be low.Application into enclosed spaces should only be carried out whenthe structure is clear of bystanders and appropriately sealed toprevent leakage. The risks to bystanders (including children) fromUse Scenarios 9 to 25 are, therefore, considered to be low. Ventingof treated structures (intentional or inadvertent) would result in apoint-source emissions that ERMA New Zealand considers will beadequately dispersed by air movement so that bystanders are notexposued to hazardous concentrations of dichlorvos.Exposure of children through contact with treated surfaces arisingfrom domestic use of dichlorvos-containing insecticide treatments(Use Scenarios 26 to 29) are estimated to reflect the bystanders atgreatest risk, and are considered by ERMA New Zealand to be veryhigh, given that the RQ values are > 880. Additionally, ERMANew Zealand has not been able to determine an REI for child entryinto treated areas.The exposures that children from contact with treated public areas(Use Scenario 30) are considered by ERMA New Zealand to bevery high, with an RQ of 86.ERMA New Zealand semi-quantitatively assessed the risk ofexposure to operators arising from the use of dichlorvosimpregnatedinsecticide strips (Use Scenario 31). Bystanders couldbe exposed to dichlorvos if they are close to an open trap, whichcould result from deliberate action or vandalism. ERMA NewZealand notes that these traps are placed on private property at least1.3m above ground, are labelled and the property owner is fullyinformed, providing some level of security against interference,vandalism or access by small children. The magnitude of an effectis considered to be minimal to major, depending on the degree ofexposure. The likelihood of a major adverse health effect to amember of the public is considered to be highly improbable. Thelikelihood of a minimal adverse health effect to a member of thepublic is considered to be unlikely at most. ERMA New Zealandconsiders the level of risk to bystanders and children is thereforenegligible to low.4.5 Summary of exposure risks to the environment and humanhealth.4.5.1 A summary of the level of risk to human health and the environment posed bydichlorvos-containing substances is detailed in Table 12.Dichlorvos reassessment – application Page 54 of 436

Table 12.LifecycleStageImport,manufacture,transport,storage ordisposalUse – aquatic,terrestrialenvironmentsand organismsUse – aquaticenvironmentUse –terrestrialenvironment(birds)Use –terrestrialenvironment(non-targetsoil dwellingorganisms)Use –terrestrialenvironment(non-targetterrestrialinvertebrates)Summary of the level of risk posed by use of dichlorvos-containing substances.UseScenarioPotentialadverse effect1 – 31 (all) Adverse acute orchronicenvironmenteffectsMagnitude ofAdverseEffectsModerateLikelihoodof AdverseEffectOccurringHighlyimprobableLevel of RiskNon-negligible(Negligible tolow)9 – 29, 31 Adverse acute or No risk posed.None.chronic30 environment Moderate Unlikely Non-negligibleeffects(Low)1 - 8 Adverse acute orchronicenvironmenteffects1 - 8 Adverse acute orchronicenvironmenteffects1 – 4, 7 - 8 Adverse acute orchronicenvironmenteffectsQuantitative assessmentindicates that use ofdichlorvos:does not pose a significantrisk to aquatic plants andfish;poses a significant risk toaquatic invertebrates;is considered to pose norisk to sediment,groundwater or themarine environment.Quantitative assessmentindicates that use of dichlorvosposes a significant risk to birdsthat requires refinedassessment or management.Quantitative assessmentindicates that use of dichlorvosdoes not pose a significant riskto soil dwelling organismswithin or beyond theapplication area.5 - 6 Quantitative assessmentindicates that use of dichlorvosposea a significant risk to soildwelling organisms(earthworms) that requiresrefined assessment ormanagement.1 – 8 Adverse acute orchronicenvironmenteffectsQuantitative assessmentindicates that use of dichlorvosposes a significant (high) riskto non-target terrestrialinvertebrates that requiresrefined assessment ormanagement.Non-negligible(High)Non-negligibleNegligibleNon-negligibleNon-negligible(high)Dichlorvos reassessment – application Page 55 of 436

LifecycleStageImport,manufacture,transport,storage ordisposalUseScenarioUse - operator 9 - 10,Use –restricted entryPotentialadverse effect1 – 32 (All) Adverse acuteor chronichealth effects17 - 18Adverse acuteor chronichealth effectsMagnitude ofAdverseEffectsModerateLikelihoodof AdverseEffectOccurringHighlyimprobableQuantitative assessmentindicates that use ofdichlorvos poses a significantrisk, unless appropriate PPE isused, and the number ofcylinder changes are restrictedto a maximum of 1 per dayper operator.13 - 14 Quantitative assessmentindicates that use ofdichlorvos poses a significantrisk, unless appropriate PPE isused, and other userestrictions are imposed.20 - 25 Quantitative assessmentindicates that use ofdichlorvos does not pose asignificant risk if appropriatePPE is used, and other userestrictions are imposed.1 – 4,11 – 12,15 – 16,19,26 – 27,305 – 8,28 - 29Quantitative assessmentindicates that use ofdichlorvos poses a significant(high) risk to operator health.Quantitative assessmentindicates that use ofdichlorvos poses a significant(very high) risk to operatorhealth.31 Minor to major VeryUnlikely3 – 4(scouting incerealsonly),9-25Adverse acuteor chronichealth effectsQuantitative assessmentindicates that restricted entryinto application areas wheredichlorvos has been appliedposes a significant risk, unlessappropriate PPE is used andother restricted entryrestrictions are applied.Level of RiskNegligibleNon-negligibleNon-negligibleNon-negligibleNon-negligible(High)Non-negligible(Very high)Non-negligible(Negligible tolow)Non-negligibleDichlorvos reassessment – application Page 56 of 436

LifecycleStageUse –bystanderUseScenario1 – 2,3 – 4(vegetables,berries),5 - 8Potentialadverse effectMagnitude ofAdverseEffectsLikelihoodof AdverseEffectOccurringQuantitative assessmentindicates that use ofdichlorvos poses a significant(very high) risk to the healthof operators exposed totreated areas.26 - 30 Quantitative assessmentindicates that use ofdichlorvos poses a significant(very high) risk to the healthof children dermally exposedto treated surfaces.31 Minor to major VeryUnlikely1 -8 Adverse acuteor chronichealth effectsQuantitative assessmentindicates that exposure tosurfaces exposed to spray driftdoes not pose a significantrisk.Level of RiskNon-negligible(High)Non-negligible(Very high)Non-negligible(Negligible tolow)Negligible9 - 25 No risk posed. Negligible26 - 30 Quantitative assessmentindicates that use ofdichlorvos poses a significant(very high) risk to the healthof children dermally exposedto treated surfaces.31 Minimal tomajorHighlyImprobableNon-negligible(Very high)Non-negligible(Negligible tolow)Identification of beneficial effects (benefits)4.5.2 ERMA New Zealand did not identify any direct beneficial effects on human healthand safety from the use of dichlorvos.4.6 Society and communitiesIdentification of adverse effects on society and communities4.6.1 ERMA New Zealand has not been able to find any reports of public concern aboutthe use of dichlorvos and therefore has not identified any adverse effects on societyand communities, other than those associated with health and safety, from thecontinued use of these substances. No adverse effects on society and community thatmight result from the unavailability of the substances have been identified.Dichlorvos reassessment – application Page 57 of 436

Identification of benefits to society and communities4.6.2 Benefits to society and community from the continued availability and non-plantprotection use of dichlorvos, based on its properties as an effective pesticide, areclosely allied to public health benefits. Social benefits from biosecurity use fordetection of pests such as fruitfly are considered to be adequately addressed undereffects on the market economy.4.6.3 ERMA New Zealand considers that the level of indirect benefit to public health (i.e.reduction in adverse effects through control of pests, such as cockroaches or fleas)through use of dichlorvos in large scale facilities, public buildings or public amenityareas (Use Scenarios 17 to 30) is estimated to be minimal, and is at least likely tooccur, resulting in a low level of positive effect.4.6.4 No potentially significant benefits or positive effects as a result of the unavailabilityof the substances have been identified.Overall evaluation of effects on society and communities4.6.5 ERMA New Zealand considers that there are potentially significant positive effectson society and community from the continued availability and use of dichlorvos.4.6.6 ERMA New Zealand notes that there may be additional social effects from the use ofdichlorvos and invites submitters to provide any such information they might have tosupport the identification of such effects.4.7 The market economy4.7.1 In preparing this section, ERMA New Zealand consulted with users andcommissioned a report from Plant & Food Research on the horticultural use ofdichlorvos in New Zealand and potential alternatives to its use (Plant & FoodResearch, 2009 - Appendix R).Identification of adverse effects on the market economy4.7.2 ERMA New Zealand did not identify any adverse effects on the market economyfrom the continued use of dichlorvos in horticulture, as long as there is adherence tothe relevant MRLs. Specific CODEX MRLs for dichlorvos have only been set forcereals, grains and mushrooms. MRLs for other uses therefore use the default valueof 0.1mg/kg.4.7.3 NZFSA MRLs have been set for three groups: vegetables, fruits, and cereals andgrains.4.7.4 Similarly there are no obvious adverse effects on the market economy from use forpublic health purposes.4.7.5 If there were to be a ban on the use of dichlorvos then there would be potentiallysignificant adverse effects on trade and biosecurity as a result of loss of benefits asdescribed below.Identification and assessment of beneficial effects (benefits) on the marketeconomy4.7.6 Through consultation with industry groups, ERMA New Zealand identifiedbeneficial effects on market economy as shown in Table 13. Each of thesebeneficial effects is evaluated in the following paragraphs.Dichlorvos reassessment – application Page 58 of 436

Table 13.Identification of beneficial effects on society and the economy fromimportation and use of dichlorvosBeneficial EffectMaintaining industry profitability in the horticulture sector (export and local markets)Benefits from use in the cymbidium growing industry and cut flower industryEconomic benefit associated with public health useCountering biosecurity incursions and potential effects on tradeMaintaining industry profitability in the horticulture section (export andlocal markets)4.7.7 Horticulture New Zealand has provided information about use of dichlorvos in thecapsicum and tamarillo industries and also for greenhouse use for tomatoes,capsicum and cucumber. This information has been gathered through consultationwith growers. Plant & Food Research (Plant & Food Research, 2009) has alsoprovided information about the use of dichlorvos in horticulture. This report statesthat dichlorvos is registered for use on cloverseed, brassicas, cereals, vegetables,tamarillo, passionfruit, persimmon and berryfruit, as well as ornamentals,glasshouses and mushroom houses. In 2004 six sector groups were identified asusers of dichlorvos: blueberry, tamarillo, passionfruit, persimmon, asparagus andnerines/peonies/sandersonia.4.7.8 Growers have indicated that dichlorvos is important for maintaining theirprofitability by providing an effective and cost efficient insecticide that ensures thatproduce is pest free and acceptable to the importing country.4.7.9 Dichlorvos is of particular value due to its volatility, which means that pesticidescontaining dichlorvos have short withholding periods, and can be used close toharvest, where other products might be precluded. This volatility also makes ituseful for use on overseas exports since the volatility results in low MRLs. It tendsto be used just once before harvest and usually only if an insect problem is identified(John Hicking pers. comm.).4.7.10 Dichlorvos is valued for its combination of physical and chemical properties,allowing its use where use of other insecticides would be less appropriate, but due toits broad activity spectrum is not used for integrated pest management (J. Hickingpers. comm.).4.7.11 Dichlorvos is considered an essential tool for capsicum growers and HorticultureNew Zealand states that all NZ capsicum growers use dichlorvos against thrips(sometimes on a weekly basis). There is no specific alternative. The value of thecapsicum export crop is of the order of $33 million (approximately 15,000 tonnes).The local market is valued at approximately $35 million. The main benefit ofdichlorvos is its volatility resulting in no residue detection after a very few days.Information provided by Horticulture New Zealand notes that dichlorvos is excellentfor the capsicum export industry to Japan as no residue can be detected after threedays. New Zealand preharvest intervals vary from one day for asparagus to sevendays for tamarillo and passionfruit.4.7.12 Plant & Food Research (Plant & Food Research, 2009) did not report specifically onuse of dichlorvos for capsicum, but note that dichlorvos is used extensively inglasshouse vegetable production, moreso recently because of problems withdisruption of IPM programmes for tomatoes and capsicums.Dichlorvos reassessment – application Page 59 of 436

4.7.13 BOC gases provided information about use on capsicum referring to the use ofArmourCrop (DDVP).4.7.14 Horticulture New Zealand notes that the tamarillo industry uses dichlorvos (Nuovos)against a range of pests including aphids, whitefly, caterpillars, mites and greenvegetable bug up to seven days before harvest. It is reportedly used about one yearin three in Northland, Bay of Plenty, Auckland, Taranaki and Gisborne, and whilethe amount used is unknown it is estimated as being less than 50 litres (of the madeup product). Alternatives are available, but dichlorvos has a shorter withholdingperiod. Two systemic products are available (ie need less application) but one ofthese products currently requires zero residue. The value of the export crop is justunder $1million, and the local market around $1.4 million.4.7.15 Plant & Food Research (ibid) supports this information, giving a slightly higherfigure (SNZ1.1m) for the value of the export crop. The main alternative product hasa 60 day preharvest interval for export fruit but only seven days for local fruit.Tomato/potato psyllid infestation in 2009 caused significant damage to tamarillocrops and dichlorvos is an important control option.4.7.16 Dichlorvos is used in greenhouses, mainly in the Auckland area, for production oftomatoes, capsicum and cucumber against thrips, whitefly and psyllid (Nuvos)between one and three times per year.4.7.17 Horticulture New Zealand states that dichlorvos is used in glasshouses as part of IPMprogrammes, either at the end of cropping or, when IPM breaks down, to knockdownhigh pest populations to enable IPM to be re-established. Dichlorvos is ofvalue because of its rapid dissipation enabling IPM to be reintroduced within 1 dayof treatment. While there are other means of controlling these pests, if dichlorvoswere not available then less IPM would be used. No value for the export crop hasbeen given. Horticulture New Zealand states that it is hard to estimate tonnage, butmakes an assessment of around 750kg of the active ingredient.4.7.18 The Plant & Food Research report (ibid) concurs with the Horticulture New Zealandevaluation noting particularly the adverse effect of the establishment oftomato/potato psyllid in New Zealand.4.7.19 Adria Crop Protection states that dichlorvos (Divap) may be used on berryfruit andvegetables for sucking insects, as well for public health purposes against flies andmosquitoes. They state that approximately 0.4 tonnes is used annually in Auckland,Hawkes Bay, Nelson/Marlborough and Canterbury.4.7.20 Plant & Food Research (ibid) report that fumigation of fresh asparagus withdichlorvos is ―standard practice for export asparagus‖. In 2008 the value of exportsales was $N2.5m. Currently the only alternative is methyl bromide, which is lesseffective and shortens shelf life because of the higher temperature required.4.7.21 Dichlorvos is registered for use on clover and vegetable seed and may be being used,but probably only at small levels as other products are available. Similarly Plant &Food Research (ibid) report that there is little current use for cereal crops.Dichlorvos is also registered for use on mushrooms but is not currently used.4.7.22 Passionfruit is considered to be a minor crop, but Plant & Food Research (ibid) notethat because of this it is not able to fund trials of alternatives and there are only twoinsecticides registered for use on passionfruit – dichlorvos and diazinon.4.7.23 Information received from industry indicates that dichlorvos contributes significantlyto the facilitation of trade in the horticulture industry, with particular reference totrade in tomatoes, capsicum and cucumber. While the value of total trade is high, theDichlorvos reassessment – application Page 60 of 436

value that can be attributed to dichlorvos is unknown. ERMA New Zealand notesthat dichlorvos has specific benefits associated with its volatility, and that there arelimited alternatives available at the present time, particularly for the minor cropssuch as persimmons, tamarillos and passionfruit. ERMA New Zealand cannotdetermine the amount of the value of the crops that can be attributed specifically tothe use of dichlorvos, but accepts the view presented by Horticulture New Zealandand Plant & Food Research that it is potentially significant.4.7.24 It is interesting to note that Japan is moving towards not allowing import of freshasparagus that has been treated with dichlorvos (Plant & Food Research). Japan isNew Zealand‘s major market for vegetable products taking 34% by value ofvegetable exports in 2009. Australia is the second biggest market at 23% (the UnitedStates of America is 3%). For fruit and vegetables the respective figures are 19%,14% (6%), with the EU taking 16%. If Japan were to extend this requirement toother produce then alternatives would need to be found quickly.4.7.25 Based on the information provided by Horticulture New Zealand and Plant & FoodResearch, and noting the specific benefits provided by dichlorvos (e.g. rapiddissipation), ERMA New Zealand considers that a minimal benefit is at least likely,resulting in a low level of positive effect.Benefits from use in the cymbidium growing industry and cut flowerindustry4.7.26 Information provided by the Northland Cymbidium Growers Association based on anational survey of cymbidium growers suggests that dichlorvos is used in thecymbidium industry mainly in the Northland and Auckland regions. Some growersuse it regularly while others use it as a chemical of last resort. Its volatility isvaluable here as well with relatively short restricted entry periods.4.7.27 The survey looked at the availability of alternatives, and growers were generally notaware of any product that would fill the particular function for which they useddichlorvos. Respondents that considered alternatives showed preference for otherorganophosphates in general, though no specific substances were identified.4.7.28 Cymbidiums have been consistent performers for a number of years. In 2003 thetotal value for exported cut flowers and foliage was just under $40m ($NZ38.5m forthe 2004-5 season). Plant & Food Research indicate that in 2009 this had risen toapproximately $NZ60m. In 2004-5 cymbidiums accounted for approximately half ofthis value, dropping to about one third ($NZ22m) in 2009. In 2005/6 Japan took51% of New Zealand flower exports and the United States 29%.4.7.29 Cymbidiums are therefore a significant export crop. Currently dichlorvos is used forscale insect and mite control with its main value being that it can be used within oneday of harvesting or packing. Based on the information provided about the use andvalue of dichlorvos to the cymbidium industry, ERMA New Zealand considers that aminimal benefit to the cut flower industry is unlikely thus leading to a negligiblebenefit. This does not mean that the export crop is not significant, but rather that thecontribution of dichlorvos to cymbidium production in terms of a national benefit isnot significant.Economic benefit associated with public health use4.7.30 Dichlorvos is considered to be particularly important for insect pest control in thedairy industry where control of products is difficult because of large, structures andyear round operations with short periods available for insect control. ReportedlyDichlorvos reassessment – application Page 61 of 436

dichlorvos is used prior to startup of plants. Pest control programmes are generallycontracted out to companies such as Ecolab and Rentokil. In the past the dairyindustry used methyl bromide, but this is no longer available.4.7.31 Rentokil has indicated that dichlorvos is used to kill general insect and arachnid pests(Nuvos and Insectigas) and highlighted use in the dairy industry. While it is usedinfrequently it is considered vital for such purposes.4.7.32 The information provided by the industry suggests that dichlorvos has replacedmethyl bromide.4.7.33 The use of dichlorvos for the fumigation of large scale facilities, and as a hygienetreatment to control fleas and cockroaches is a public health4.7.34 The economic benefit associated with this use could be measured in terms ofdowntime that would accrue if other products were used. The imposition ofadditional controls might also result in higher costs, but the extent of this cost is notknown. Since dichlorvos is used infrequently for this purpose ERMA New Zealandconcludes that any additional cost would be comparatively small and therefore wouldnot be potentially significant in terms of effect on the market economy.Countering biosecurity incursions and potential effects on trade4.7.35 MAF-BNZ has provided information about the use of dichlorvos for the NewZealand fruit fly surveillance programme (DDVP insecticide strips). Estimatedamount is around 15kg of the active ingredient per year. No current alternatives havebeen identified.4.7.36 Fruit Fly surveillance has been in place for more than 20 years and there have beensix fruit fly incursions, the last in 1996.4.7.37 MAFBNZ has indicated that trade in horticulture produce is worth $2.2 billionannually to New Zealand. Ninety percent by value of this is fresh fruit andvegetables that could be affected by introduction of fruit flies.4.7.38 There are several thousand fruit fly species but a few are very economicallyimportant; Ceratistis spp, e.g. Mediterranean and South African fruit flies (alsofound in Hawaii, Central and South American, Western Australia), Bactrocera spp ,e.g. Queensland fruit fly, Oriental fruit fly, Pacific Island fruit fly, melon fly (allfound in various temperate and tropical regions), Anastrepha spp, e.g. Central andSouth American fruit fly , Rhagoletis spp found in North America and Europe. Thelures used in the fruit fly traps in New Zealand are primarily targeting theMediterranean, Oriental and Queensland fruit flies, and other lure responsive species.The Mediterranean fruit fly is known to attack more than 250 different fruit andvegetables including avocado, citrus, feijoa, grape, peppers, persimmon, pip fruit,stone fruit and walnut and is ranked as the world‘s most economically damaging fruitfly.4.7.39 In its application to ERMA New Zealand for approval for DDVP fruit fly detectionstrips containing dichlorvos (HSR04011), MAF stated that the fruit fly monitoringprogramme provides economic benefit to New Zealand through assurance tooverseas trading partners that New Zealand produce is free of fruit fly infestation.This provides New Zealand exporters with an advantage over other countriesexporting the same crops.4.7.40 In the event of an outbreak some markets (e.g. Japan) would become inaccessiblewhile other markets would require produce to be treated (by heat or using pesticides),which would add cost and might produce market access problems. During the 1996Dichlorvos reassessment – application Page 62 of 436

outbreak, MAF‘s ability to demonstrate the effectiveness of the surveillanceprogramme meant that barriers to New Zealand‘s trade were substantially reduced.4.7.41 With New Zealand remaining fruit fly free the horticultural industry enjoys somecompetitive advantages. Production costs are reduced (no additional physical orchemical treatments to produce, no added insecticide treatments to crops). Productquality can maintain a high standard; fruit fly attack causes the premature drop offruit as well as making fruit inedible (maggots in fruit).4.7.42 The most recent fruit fly detection occurred in 1996 when two Mediterranean fruitflies were trapped in Mt Roskill. All flies located as part of the subsequenteradication campaign were detected within 200 m of the original identification site.The reported cost of eradication and monitoring to confirm the success of theprogramme is $6 million.4.7.43 The cost of the programme is not insignificant, however it is considered theeconomic benefit to New Zealand horticultural industry and international tradejustifies the investment in this biosecurity programme.4.7.44 Without an effective active and rapid surveillance programme to detect fruit flypopulations rapidly, should these pests become established it is anticipated thateradication would cost $100 million. There would be additional costs associatedwith the impact on existing exports (see above).4.7.45 Early detection of an unwanted pest such as the fruit fly means that a population canbe eradicated more easily than would be the case when the pest becomes established.This means eradication is faster and at a lesser cost.4.7.46 With people and goods passing through New Zealand borders every day fromregions where fruit fly is well-established, the likelihood of a possible incursion isrelatively high.4.7.47 Taking into account the high cost of eradication of pests as well as the likelihood ofincursion, ERMA New Zealand considers that a moderate benefit is unlikely tolikely, resulting in a low to medium level of positive effect.Overall evaluation of effects on the market economy4.7.48 No adverse effects on the market economy have been identified for either thebaseline Outcome Scenario (continued use with current controls) or OutcomeScenario (b) (continued use with revised controls). This is primarily becausepotential adverse effects on trade are managed commercially by adherence toCODEX MRLs, and the requirements of export markets.4.7.49 With respect to the Cymbidium and cut flower industries the conclusion reachedabove it that the level of benefit to the overall market economy from use ofdichlorvos is these industries is negligible, based on the conclusions that while theexport crop of cymbidium is significant to that industry, the contribution ofdichlorvos to cymbidium production in terms of a national benefit is not significant.ERMA New Zealand would value further information in this area. However, sincethere are no adverse effects on the market economy from the continued use ofdichlorvos, the positive effects (albeit small) must be considered to outweigh theadverse effects for both continued use with existing controls and continued use withrevised controls.4.7.50 Similarly, while the level of economic benefit from the use of dichlorvos forfumigation of large structures (public health use) is not considered to be significant,the positive effects of its use outweigh the adverse effects for both OutcomeDichlorvos reassessment – application Page 63 of 436

Scenarios (a) and (b). There do not appear to be any effective alternatives currentlyavailable. Thus the loss of the product would result in potential benefits that mayarise from its availability not being realised, which is classed as an absence of benefit(i.e. none), rather than an adverse effect. ERMA New Zealand invites submitters toprovide further information.4.7.51 In terms of effects on trade with respect of the use of dichlorvos for counteringbiosecurity incursions, the level of benefit on trade has been assessed low tomedium. Since there are no adverse effects associated with this use, the positiveeffects outweigh the adverse effects for both Outcome Scenarios (a) and (b). Ifdichlorvos were unavailable (Outcome Scenario (c)), loss of the product would resultin potential benefits arising from its availability not being realised, an absence ofbenefit (i.e. none), rather than an adverse effect.4.7.52 In terms of maintaining industry profitability in the horticulture sector, the two areaswhere effects could be expected to be potentially significant are the asparagusindustry, and glasshouse production of tomatoes, capsicum and cucumber. However,while the volatility of dichlorvos means that residues cannot be detected after a shortnumber of days, Japan, which is a significant market, is moving towards notaccepting product that has had dichlorvos used on it. ERMA New Zealand wouldwelcome further information about the possible ban and the value of product going toJapan. ERMA New Zealand has concluded that the overall benefit of dichlorvos tothe horticulture sector, and specifically the glasshouse production of tomatoes,capsicum and cucumber are at least low, and therefore the positive effects outweighthe adverse effects for Outcome Scenarios (a) and (b). If dichlorvos wereunavailable (Outcome Scenario (c)), loss of the product would result in potentialbenefits arising from its availability not being realised, an absence of benefit (i.e.none), rather than an adverse effect.4.7.53 These assessments are based on limited information, and ERMA New Zealand hasendeavoured to be conservative in terms of estimating the level of benefit and toadopt a risk averse position in terms of estimating the level of risk/cost.4.8 Māori interests and concernsRelationship of Māori to the environment4.8.1 Iwi/Māori interests have not been specifically consulted in the preparation of thisapplication. However ERMA New Zealand has received clear messages at severalhui with iwi/Māori resource managers that unless substances provide clear benefits tooutweigh potential risk, they generally oppose the ongoing use of highly hazardoussubstances. It is likely that, in the absence of further information regarding benefits,submissions from Māori would seek the revocation of the approvals for dichlorvosand its approved formulations.Treaty of Waitangi4.8.2 Section 8 of the Act requires the Authority, when considering applications, to takeinto account the principles of the Treaty of Waitangi. Of particular relevance to thisapplication is the principle of active protection affirmed by the Court of Appeal inthe Lands case (1987).4.8.3 This principle refers to the Crown‘s obligation to take positive steps to ensure thatMāori interests are protected, and to consider them in line with the interestsguaranteed to Māori in Article II of the Treaty. Specifically the Court noted that ―…Dichlorvos reassessment – application Page 64 of 436

the duty of the Crown is not merely passive but extends to active protection of Maoripeople in the use of their lands and waters to the fullest extent practicable‖.4.8.4 Taking into account the principle of active protection requires this application toprovide sufficient evidence to show that the use of dichlorvos and its approvedformulations pose no risk of adverse effects to native/endemic species and/or othertaonga species, ecosystems and traditional Māori values, practices, health and wellbeing.Having considered the information available in relation to the adverse effectsnoted above, ERMA New Zealand considers that retaining the current approvals fordichlorvos and its formulations would be inconsistent with the principle of activeprotection.4.9 International obligations4.9.1 ERMA New Zealand has not identified any international obligations regardingdichlorvos.4.9.2 The use of dichlorvos and formulations has been reviewed by several overseasjurisdictions (Appendix L). These reviews do not pose an obligation on NewZealand but are relevant to consideration of risks and pertinent risk managementmeasures.Dichlorvos reassessment – application Page 65 of 436

SECTION 5– LIKELY EFFECTS OF DICHLORVOS BEINGUNAVAILABLE5.1 Introduction5.1.1 ERMA New Zealand considered alternative scenarios that might arise if the use ofdichlorvos was restricted or prevented. In particular, the availability of alternativepesticides was considered. It is noted that the list of alternatives identified may notbe a complete representation of all available alternatives, and ERMA New Zealandwelcomes additional information on potential alternative substances.5.1.2 Detailed information on the comparability of the alternative products has not beengathered, in particular:relative efficacy;the research required to determine if they are indeed suitable alternatives;comparability of properties for which dichlorvos is valued, rapid knockdown,rapid dissipation, broad spectrum activity, suitability for fogging;for plant protection products, compatibility with IPM.5.1.3 It is noted that restricting the suite of pesticides available may lead to a reducedability to manage pest resistance.5.1.4 Overseas, the use of dichlorvos as a plant protection product is no longer permitted,or it is proposed that it be terminated. Reviews leading to these restrictions do notdiscuss the availability of alternative products (APVMA, 2008; USEPA, 2006;PMRA, 2008; EU, 2003, 2006, 2007), but the pests that are managed by dichlorvosin New Zealand are present overseas and overseas growers must have alternativemeans of managing them. In the Netherlands, for example, when dichlorvos wasremoved from the market, greenhouse growers used methiocarb, spinosad, abamectinand methomyl to control thrips, imidacloprid, acetamiprid, pymetrozine, flonicamidand thiacloprid to control whitefly and aphids (van der Staaij pers. comm.),pyrethrum and beneficials to clean out greenhouses (Kerklaan pers. comm.). Noapplication for approval of flonicamid (active ingredient or formulations) or ofacetamiprid formulations has been made in New Zealand but the other pesticidesused in the Netherlands are approved.5.1.5 Dichlorvos is used more widely in non-agricultural (plant protection) situationsoverseas (Section 3).Availability of alternative plant protection products5.1.6 Users have identified some alternative products, but none with all the properties thatmake dichlorvos valuable in many applications, i.e.:Rapid knockdown;Short pre-harvest intervals;Broad-spectrum activity;Suitability for fogging and resultant good penetration.5.1.7 Users commented on alternatives as follows:Dichlorvos reassessment – application Page 66 of 436

5.1.7.1 J. Hicking stated that dichlorvos EC tends to be used once, shortly beforeharvest and only if an insect problem is identified, its volatility makes itideal under these conditions. At other times, other pesticides are used,for example, synthetic pyrethroids including α-cypermethrin anddeltamethrin and organophosphates including diazinon and chlorpyrifos.5.1.7.2 Horticulture New Zealand suggested Chess (pymetrozine) and Calypso(thiacloprid) are used by tamarillo growers, Confidor (imidacloprid),Chess (pymetrozine), Ovation (buprofezin), Lannate (methomyl), Mavrik(tau-fluvalinate) and Avid (abamectin) by glasshouse growers.Horticulture New Zealand add that the last three of these products are notcompatible with IPM. If IPM is not used, weekly sprays alternatingLannate and Confidor are used. They suggest that if dichlorvos was notavailable glasshouse growers would use less IPM.5.1.7.3 NCGA indicated that synethetic pyrethroids can be used to control twospottedmite (Tetranychus urticae), but their use is problematic to somegrowers because it is difficult to establish the predatory mitePhytoseiulus persimilis for some time after treatment. However, P.persimilis is used only for a limited time window and use of IPM is givenlow priority by the industry as a whole.5.1.7.4 Horticulture New Zealand indicates that Movento (spirotetramat) is anew product that will be of value to glasshouse growers (crop and pestnot specified) and Oberon (spiromesifen) would also be of value. Thereare beneficial insects available overseas, but not available in NZ.5.1.7.5 Horticulture New Zealand capsicum growers say no alternatives againstthrips except Match (lufenuron) & Success (spinosad) used together anddichlorvos – none of the old organophosphate chemistry is effective.5.1.7.6 Biosecurity NZ stated in application HSR04011: In the past malathionhas been used in traps as an insecticide. However this required injectingliquid malathion into dental wicks. This was messy and potentiallydirectly exposes contractors to higher concentrations of anorganophosphorus insecticide, more chance of contamination of trapcomponents and a higher risk of variability between traps.5.1.7.7 Sections of the report from Plant & Food (Appendix N) that discussalternatives can be summarized:5.1.7.7.1 Persimmon:Dichlorvos is valued as pre-harvest treatment to controlpassenger pests such as oribatid mites. Physical controlsand synthetic pyrethroids and pyrethrum have been trialedbut were ineffective in controlling these passenger pests.There are no alternatives that are effective in controllingthe range of pests in persimmons with rapid decline inresidues;5.1.7.7.2 Passionfruit:Dichlorvos is used to treat thrips, which get under the skincausing ‗pimpling‘. Diazinon and dichlorvos are the onlyinsecticides registered for use on passionfruit. Spinosadmight be effective, but is not registered, and given the sizeof the industry, growers are unable to fund the trialsneeded;Dichlorvos reassessment – application Page 67 of 436

5.1.7.7.3 Tamarillos:A range of insecticides is registered for use on tamarillo,including carbaryl, acephate, diazinon, pymetrozine,deltamethrin, taufluvalinate, buprofezin and dichlorvos.Tomato/potato psyllid is a new and particularly damagingpest, which killed up to 60% of trees in 2009. Severalproducts, including some not registered on tamarillo, havebeen tested to see if they will control tomato/potatopsyllid, including thiacloprid, Success Naturalyte,spiromesifen and chlorotraniliprole. Dichlorvos,deltamethrin and abamectin have shown best control, butdichlorvos is preferred due to its short pre-harvest interval;5.1.7.7.4 Berryfruits:The main pests are bronze beetle on blueberries andCarpophilus beetle on strawberries both of which becomemore important as more persistent organophosphates areremoved from production programmes. Dichlorvos hasproved effective and its short pre-harvest interval is alsoan attraction. No alternative products have beenidentified, but it is not clear how much research has beenperformed;5.1.7.7.5 Ornamentals and cut flower production:Dichlorvos is used in ornamental and cut flowerproduction, particularly Cymbidium production. IPM isused for two-spotted mite (T. urticae) control anddichlorvos is a part of this management system becausethe eggs of the predatory mite, Phytoseiulus persimillis arenot affected. In addition, the fumigant action ofdichlorvos means that blooms do not get wet, which cancause disease. There is interest in using dichlorvos forlightbrown apple moth control in cut flowers and foliage.No alternative products were identified;5.1.7.7.6 Glasshouse vegetables:Dichlorvos is used fairly extensively because it can beused in a fogger which is quicker than applying a wetspray. It is used for clean-up of glasshouses and to knockdown pests prior to introduction of bees or predator mites.There are no alternative products that can be used infogging equipment. Tomato/potato psyllids establishmentin New Zealand is a particular problem for the glasshousetomato and capsicum industry and dichlorvos is one of 25pesticides listed for control of this pest, most of whichhave pre-harvest intervals as short as the 3 day periodapplicable to dichlorvos (Horticulture NZ, 2008);5.1.7.7.7 Mushrooms:Dichlorvos is not currently used, but deregistration wouldleave very few insecticides registered for use onmushrooms. Biological control agents, Hypoaspsaculeifer and Steinemema feltiae and fipronil anddiflubenzuron are registered alternatives, althoughdichlorvos could be used against a wider range of pests;Dichlorvos reassessment – application Page 68 of 436

Table 14. Comparative of hazard classifications of other insecticide active ingredients applied to products on which dichlorvos is used.Crop Pest Active ingredient Preharvestperiod(days)Persimmon Passenger pestssuch as oribatid ChlorpyrifosmitesDiazinonPassionfruitDichlorvos reassessment – application Page 70 of 436Status 6.1 6.1 6.1 6.6 6.7 6.8 6.9 9.1 9.2 9.3 9.4 BioaccumulativeDichlorvos 2 6.1B 6.1B 6.1B 6.6B 6.7B No 6.9A 9.1A 9.2D 9.3A 9.4A No YesCarbarylTrialed butineffectiveUnspecified Permethrin 7 May be 6.1C No No No No No 6.9B 9.1A ND 9.3B 9.4A Yes YesPirimiphos-methyl 7withdrawndue towithdrawal 6.1E 6.1D ND No ND 6.8B 6.9A 9.1A ND 9.3A 9.4A Yes Nofrom NZKiwifruitCropProtectionProgrammeChlorpyrifos ? 6.1C 6.1B 6.1D No ND No 6.9A 9.1A 9.2B 9.3A 9.4A Yes NoAphidsCaterpillarsWhiteflyAphidsCaterpillarsWhiteflyGrass grubbeetleLeafroller,ThripsCherry slugN/ARapidbiodegradationUnspecified broadspectruminsecticidesNANDDichlorvos 2 6.1B 6.1B 6.1B 6.6B 6.7B No 6.9A 9.1A 9.2D 9.3A 9.4A No YesDiazinon 14 Registered 6.1C 6.1C 6.1D ND No 6.8B 6.9A 9.1A 9.2D 9.3A 9.4A No NoSpinosad 3 Notregistered forpassionfruit,registered forsummerfruitMaldisonRecentlywithdrawnfrom NZ6.1E No No ND ND ND 6.9B 9.1A No No 9.4A No No6.1D 6.1E 6.1E ND No 6.8B 6.9A 9.1A ND 9.3B 9.4A No No

Crop Pest Active ingredient Preharvestperiod(days)marketStatus 6.1 6.1 6.1 6.6 6.7 6.8 6.9 9.1 9.2 9.3 9.4 BioaccumulativeRapidbiodegradationTamarillosAphidsCaterpillars,WhiteflySome control oftomato/potatopsyllid.Tomato/potatopsyllidDichlorvos 7 6.1B 6.1B 6.1B 6.6B 6.7B No 6.9A 9.1A 9.2D 9.3A 9.4A No YesDeltamethrin 7 PHI 60 daysfor exportAbamectin ? Not availablefor exportcropThiaclopridTrialed butPymetrozineineffectiveSpinosadBuprofezinSpriomesifenChloantraniliprole6.1B 6.1C 6.1C No ND No 6.9A 9.1A 9.2C 9.3A 9.4A Yes No6.1B ND ND No No 6.8B 6.9A 9.1A 9.2A 9.3A 9.4A No NoCaterpillar Carbaryl 1 6.1C 6.1D ND No 6.7B No 6.9B 9.1A 9.2B 9.3B 9.4A No NoGrass grubbeetleLeafrollerAphids Acephate 14 6.1D No ND No 6.7B 6.8B 6.9A 9.1D No 9.3B 9.4A No YesCaterpillarsGrass grubbeetleAphids Diazinon 14 6.1C 6.1C 6.1D ND No 6.8B 6.9A 9.1A 9.2D 9.3A 9.4A No NoCaterpillarsGrass grubbeetleAphids, Pymetrozine 14 No ND ND No ND No 6.9B 9.1C No No No No NowhiteflyWhitefly Deltamethrin 7 PHI 60 days 6.1B 6.1C 6.1C No ND No 6.9A 9.1A 9.2C 9.3A 9.4A Yes NoN/ADichlorvos reassessment – application Page 71 of 436

Crop Pest Active ingredient Preharvestperiod(days)Grass grubStatus 6.1 6.1 6.1 6.6 6.7 6.8 6.9 9.1 9.2 9.3 9.4 Bioaccumulativefor exportGreen peach Taufluvalinate 60 6.1C No ND No ND No 6.9B 9.1A No 9.3B 9.4B No NoaphidWhiteflyWhitefly Buprofezin 7 6.1D No ND No ND ND 6.9B 9.1D No 9.3C ND Yes NoBerryfruits Bronze beetle Unspecified broadCarpophilus spectrumbeetleinsecticidesOrnamentals Mites & insects Unspecified broadand cutspectrumflowers,insecticidesincludingCymbidiumorchidsGlasshousevegetablesVariousincludingwhitefly &aphids,tomato/potatopsylllidNDNDRapidbiodegradationDichlorvos 36.1B 6.1B 6.1B 6.6B 6.7B No 6.9A 9.1A 9.2D 9.3A 9.4A No Yes(toms)3(caps)Methomyl 26.1B No 6.1B No No No 6.9B 9.1A 9.2A 9.3A 9.4A No No(toms)2(caps)Oxamyl ? 6.1A 6.1E 6.1B No No No 6.9B 9.1A 9.2A 9.3A 9.4A No NoPirimicarb 3(toms)? (caps)Diazinon 3(toms)14(caps)Maldison 3(toms)3(caps)6.1C ND 6.1B ND ND No 6.9B 9.1A ND 9.3A 9.4C No No6.1C 6.1C 6.1D ND No 6.8B 6.9A 9.1A 9.2D 9.3A 9.4A No No6.1D 6.1E 6.1E ND No 6.8B 6.9A 9.1A ND 9.3B 9.4A No NoDichlorvos reassessment – application Page 72 of 436

RapidbiodegradationCrop Pest Active ingredient Preharvestperiod(days)Methamidophos 3(toms)? (caps)Pirimiphos-methyl 3(toms)3(caps)Alphacypermethrin3(toms)Deltamethrin 3Lambdacyhalothrin(toms)3(toms)? (caps)Taufluvalinate 3(toms)? (caps)Status 6.1 6.1 6.1 6.6 6.7 6.8 6.9 9.1 9.2 9.3 9.4 Bioaccumulative6.1B 6.1B 6.1B ND No ND 6.9A 9.1A 9.2B 9.3A 9.4A No Yes6.1E 6.1D ND No ND 6.8B 6.9A 9.1A ND 9.3A 9.4A Yes No6.1B ND ND No ND No 6.9B 9.1A No 9.3B 9.4A No No6.1B 6.1C 6.1C No ND No 6.9A 9.1A 9.2C 9.3A 9.4A Yes No6.1D ND ND No ND ND ND 9.1A ND ND ND Yes Yes6.1C No ND No ND No 6.9B 9.1A No 9.3B 9.4B No NoImidacloprid ? 6.1C No No No No No 6.9B 9.1A 9.2A 9.3A 9.4A No NoThiacloprid ? 6.1D No 6.1D No 6.7B 6.8B 6.9B 9.1A 9.2C 9.3B 9.4C No Nothiamethoxam ? 6.1D No No No No ND 6.9B 9.1B No 9.3C 9.4A No NoSpinetoram ? No No No No No No 6.9B 9.1A No No 9.4A No NoSpinosad 36.1E No No ND ND ND 6.9B 9.1A No No 9.4A No No(toms)? (caps)Abamectin 36.1B ND ND No No 6.8B 6.9A 9.1A 9.2A 9.3A 9.4A No No(toms)? (caps)Pymetrozine 3No ND ND No ND No 6.9B 9.1C No No No No No(toms)? (caps)Novaluron ? No No No No ND No 6.9B 9.1A No No No Yes NoBuprofezin 3(toms)3(caps)6.1D No ND No ND ND 6.9B 9.1D No 9.3C ND Yes NoDichlorvos reassessment – application Page 73 of 436

Crop Pest Active ingredient Preharvestperiod(days)FieldvegetablesAsparagusMushroomsDichlorvos reassessment – application Page 74 of 436Status 6.1 6.1 6.1 6.6 6.7 6.8 6.9 9.1 9.2 9.3 9.4 BioaccumulativeFenpyroximate ? 6.1C No 6.1B ND No ND 6.9B 9.1A 9.2C 9.3B ND Yes NoRapidbiodegradationSpiromesifen 1No No No No No No 6.9B 9.1A No No No Yes Yes(toms)1(caps)Spirotetramat ? No No No No No 6.8B No 9.1A No No No No NoChlorantraniliprole ? No No No no ND No No 9.1A No No No No NoThrips Lufenuron ? (caps) No No No ND ND ND 6.9B 9.1A No No No Yes NoUnspecifiedAphidsCaterpillarsMitesThripsSpinosad ? (caps) 6.1E No No ND ND ND 6.9B 9.1A No No 9.4A No NoMethiocarb 6.1B 6.1C 6.1B No No No 6.9B 9.1A 9.2A 9.3A 9.4A No YesAbamectin 6.1B ND ND No No 6.8B 6.9A 9.1A 9.2A 9.3A 9.4A No NoMethomyl 6.1B No 6.1B No No No 6.9B 9.1A 9.2A 9.3A 9.4A No NoUnspecified broadNDspectruminsecticidesDichlorvos 1 6.1B 6.1B 6.1B 6.6B 6.7B No 6.9A 9.1A 9.2D 9.3A 9.4A No YesGarden weevil Esfenvalerate 1 6.1C No 6.1B No No No 6.9A 9.1A ND 9.3B 9.4A Yes YesPhorid & sciaridfliesMitesAphidsCaterpillarsThripsWhiteflySciarid, cecidand phorid fliesDichlorvos 3 6.1B 6.1B 6.1B 6.6B 6.7B No 6.9A 9.1A 9.2D 9.3A 9.4A No YesFipronil 14 6.1C 6.1C 6.1B No ND ND 6.9A 9.1A ND 9.3A 9.4A Yes NoSciarid flies Diflubenzuron ? No No No No ND NO 6.9B 9.1A No No No No NoFruit fly monitoring Dichlorvos 3 6.1B 6.1B 6.1B 6.6B 6.7B No 6.9A 9.1A 9.2D 9.3A 9.4A No YesDiazinon - 6.1C 6.1C 6.1D ND No 6.8B 6.9A 9.1A 9.2D 9.3A 9.4A No NoMaldison - 6.1D 6.1E 6.1E ND No 6.8B 6.9A 9.1A ND 9.3B 9.4A No No

5.2.5 ERMA New Zealand identified the following sources of uncertainty in performingthis comparative analysis:Hazard assessment is not an indication of the risk posed by a substance, sinceexposure is not taken into account, but it can be used as an indicator ofpotential to cause effects.The concentration of active ingredient in the formulated product is also critical.It is quite possible for the hazard classification of alternative formulatedproducts to be less than that of dichlorvos containing formulations even whenthe active ingredients are more hazardous (and vice versa) and this is not takeninto account in Table 14.There may be other active ingredients than those considered in these alternativescenarios if dichlorvos was not available;Restricting the suite of pesticide modes of action available may lead to areduced ability to manage pest resistance.Dichlorvos reassessment – application Page 75 of 436

SECTION 6– PROPOSALS TO MANAGE RISKS6.1 Evaluation of options to strengthen existing controls6.1.1 The analyses in Section 4 identify that certain risks are not well managed by theexisting controls and are therefore non-negligible.6.1.2 Controls additional to those currently in place that might manage these risks aredetailed in the following paragraphs. Given the specific details of each Use Scenario,the specifc conditions that are proposed for each Use Scenario are detailed in Table7.Off Label use6.1.3 The level of risk to human health and the environment has not been evaluated for offlabeluse. The proposals to impose more stringent controls for use of dichlorvoscontainingsubstances have been developed on the basis of a risk assessment.Although some of these controls may be relevant for certain off-label uses, given theunassessed nature of off-label usage and that ERMA New Zealand does not have theinformation to determine acceptable off-label usage, ERMA New Zealand proposesthat off-label usage is prohibited. ERMA New Zealand would welcome additionalinformation to be able to assess use patterns not covered under Use Scenarios 1 to32.Use Scenarios 1 – 8: outdoor use as plant protection product6.1.4 Controls and variations to protect the environment6.1.4.1 Buffer zones:The analysis in Section 4 shows that impracticably large bufferzones would be needed to protect aquatic invertebrates from spraydrift. APVMA (2008) reached the same conclusion and proposedto prohibit the use of dichlorvos in avocados, the only remainingfield use in Australia.The level of risk posed to birds through consumption of treatedcrops cannot be mitigated by any practical control measures.Timing of application of dichlorvos-containing substances to avoidtimes bees are foraging will reduce the risks to bees, but would notreduce the risk to other non-target invertebrates that live within oradjacent to crops.ERMA New Zealand considers that it may be possible to mitigatethe level of risk posed to soil-dwelling invertebrates by reducing theapplication rate, but does not have information on the lowesteffective rates so cannot determine the effect on the level of risk.ERMA New Zealand notes that direct application of dichlorvos towater is prohibited under the controls specified in the existingcontrols suites, and does not impact on the risk posed to the aquaticenvironment from land-based application of dichlorvos. TheUSEPA (2006) have taken the same approach, introducing thecontrol: Do not apply directly to water, or to areas where surfaceDichlorvos reassessment – application Page 76 of 436

water is present or to intertidal areas below the mean high watermark.6.1.5 Controls and variations to protect operators and workers6.1.5.1 ERMA New Zealand proposes that Use Scenarios 1 to 8 are prohibitedon the basis of the unmanageable levels of risk posed to the environment.6.1.5.2 ERMA New Zealand notes that, while it might potentially be possible tomanage the non-negligible risks to operators and workers (e.g. throughuse of PPE, maximum application rates, use of engineeringtechnology),—the proposal arising from the environmental assessment means thatfurther consideration is not required; andERMA New Zealand does not have the information available to itto determine whether effective risk mitigation measures could beimplemented to protect human health.Use Scenarios 9 – 25: Indoor use (industrial)6.1.6 Controls to protect workers – greenhouse, mushroom house, warehouses6.1.6.1 Specified PPE/RPE:A minimum level of PPE is required to ensure the level of risk isnegligible. ERMA New Zealand considers that the risks to humanhealth from exposure to dichlorvos are sufficient that the level ofPPE required to ensure negligible risk should be prescribed.6.1.6.2 Remotely activated automated fogging/misting equipment:Use of automated equipment can reduce the exposure of operatorsthrough use, by removing pathway of risk to operators.The equipment should be capable of being activated remotely toensure that no operators are required to be present in the treatmentarea to initiate application.6.1.6.3 Operational controls to restrict number of cylinder changes:For use of dichlorvos-containing gases, the number of cylinderchanges is a key factor in determining operator exposure;The assessment carried out has indicated that the number ofcylinder changes should be restricted to 1 cylinder change peroperator per day. ERMA New Zealand notes that a reduction inallowable cylinder changes could result in larger volume cylindersbeing used.Additionally, appropriate levels of PPE/RPE are required to ensurethat the operator exposure risks are negligible.6.1.6.4 Restriction of maximum application rates, mixing quantities and treatedareas:Dichlorvos reassessment – application Page 77 of 436

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

6.1.11 Controls to protect bystandersRestriction of application methods to handheld or automatedfogging equipment should restrict the level of exposure posed tooperators;Use of automated remote delivery systems (i.e. no human exposureduring application) should provide a means to reduce operatorexposure to acceptable levels.6.1.11.1 Bystanders will be protected if they are kept a sufficient distance fromthe application area during application and are excluded from theapplication area for a suitable period of time after application. Methodsof doing this could include use of buffer zones, notification/signage,timing of applications to avoid times when the public are in the area andrestricted entry intervals.6.1.11.2 ERMA New Zealand, however, does not have the information todetermine any REIs for this Use Scenario.6.1.12 Controls to protect the environment6.1.12.1 No quantitative modelling of environmental exposure arising fromoutdoor, public health use of dichlorvos has been performed.Nevertheless, spray drift or runoff from treated areas could contaminatethe environment. Controls applied by APVMA (2008) to manage thisrisk are appropriate in New Zealand:Do not apply under meteorological conditions or from sprayequipment that could be expected to cause spray drift onto naturalstreams, rivers or waterways;Avoid excess spraying causing run-off from treated surfaces intountreated areas;Allow treated areas to dry before washing (or irrigating);Do not apply to exposed areas if rain is expected within 4 hours.Use Scenario 31: biosecurity fruit fly monitoring programme6.1.13 Controls to protect workers6.1.13.1 Specified PPE/RPE:The level of exposure through use can likely be reduced throughuse of PPE and RPE.6.1.13.2 Limit number of traps to be serviced per day:The level of exposure is proportional to the number of strips that anoperator handles each day.The number of traps/strips handled by operators per day should berestricted to ensure the level of PPE / RPE proposed is adequate toprevent inhalation exposure.Dichlorvos reassessment – application Page 80 of 436

6.1.13.3 Guidance to provide information for operators regarding the transport ofDDVP strips and sachets should be developed by the registrant to ensurethat operators are aware of the risks posed by open of damaged sachetscontaining DDVP strips.6.1.13.4 By specifying identification requirements to be placed on trapscontaining dichlorvos-containing strips that indicate the potential for aninhalation risk should ensure that the level of adverse effects tobystanders is negligible.6.2 Evaluation of options to reduce risk by restricting use6.2.1 The risks posed by a substance can be removed by restricting the use of thesubstance, either by revoking approvals or by imposing controls that restrict use toparticular applications. Given that no risk assessment has been carried out for offlabelusage, in order to ensure that use of dichlorvos-containing substances are usedin a manageable fashion then use must be restricted to those detailed on the productlabels, taking into consideration any implications of this reassessment.6.2.2 The discussion in Section 2 indicates that in some sectors the risks can be controlledby strengthening the controls. In sectors where this is not the case, revocation of theapproval is proposed.6.3 Effect of proposed additional controls on the level of risk6.3.1 The Use Scenarios have been reproduced in Table 15 to assist in understanding theproposed additional controls.6.3.2 The effect on the final level of risk by the addition of controls to reduce exposure isdetailed in Table 16.Table 15Summary of Use Scenarios.UseOutdooragricultural useIndoor agriculturaluseIndoor nonagriculturaluseIndoor domesticuseOutdoor domesticuseOutdoor nonagriculturaluseManufacture forexportUse Scenario1, 2 (boom application: strawberries)3, 4 (boom application: vegetables, cereals, berries)5, 6 (air-blast application: fruit - tamarillo, persimmon, berries)7, 8 (hand-held sprayer: passionfruit)9, 10, 11, 12 (automatic fogging: glasshouse crops, mushroom houses)13, 14 (automatic fogging: glasshouse flowers)15, 16 (manual spraying: glasshouse flowers)17, 18, 20, 21 (automatic fogging: enclosed space (industrial))19, 22, 23 (manual fogging: enclosed space (industrial))24, 25 (manual spraying: enclosed space (industrial))26, 27 (manual application: enclosed space (domestic))28, 29 (manual application: enclosed space (domestic))30 (manual fogging: public outdoor use)31 (MAF-BNZ fruit fly monitoring)32 (for exportation)Dichlorvos reassessment – application Page 81 of 436

Table 16Effect of additional controls on the level of risk.Use Scenario Receptor Level of Risk (with existingcontrols in place)Off-label useEnvironmentHuman HealthOutdoor use as plant protection productNon-negligible(potentially)Proposed Additional ContolUse of substances is restricted to those uses specified on theproduct label, in accordance with the outcomes of thisreassessment.Modified Level ofRiskNegligible1 - 4 Aquatic environment(invertebrates)Non-negligible (> LOC)No practical options available to reduce risk to aquaticinvertebrates.Non-negligible(High).Terrestrial environment(vertebrates)Terrestrial environment(invertebrates)Operator exposure(mixing, loading,application)Non-negligible (> LOC) No practical options available to reduce risks to birds. Non-negligible(High).Non-negligible (> LOC)Non-negligible (> AOEL)Restriction of the timing of application to avoidexposure of foraging bees.No practical options available to reduce risk to nontargetterrestrial invertebrates in or close to theapplication area.No practical options available to reduce risks to operatorsduring mixing, loading or application.Non-negligible(High).Non-negligible.Operator exposure(restricted entry)Non-negligible (> AOEL)No practical options available to reduce risks tooperators during restricted entry into treated crops,except where restricted entry is into cereals for thepurpose of scouting;Introduce a REI of 7 days, where restricted entry intocereals for scouting is prohibited without PPE/RPE;Non-negligible.(vegetables, berries)Negligible(scouting in cereals)Introduce minimum PPE/RPE requirements forrestricted entry into cereals for scouting during REI:Dichlorvos reassessment – application Page 82 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Proposed Additional ContolScouting in cereals:PPE:- hood/visor,- overalls over long-sleeved shirt and long-leggedtrousers;- boots;- gloves.RPE:- half-face respirator, with minimum specificationof A1P2.Modified Level ofRisk5 - 6 Aquatic environment(invertebrates)Terrestrial environment(vertebrates)Non-negligible (> LOC)No practical options available to reduce risk to aquaticinvertebrates.Non-negligible(High).Non-negligible (> LOC) No practical options available to reduce risks to birds. Non-negligible(High).Terrestrial environment(invertebrates)Non-negligible (> LOC)Restriction of the timing of application to avoidexposure of foraging bees.Non-negligible(High).No practical available to reduce risk to non-targetterrestrial invertebrates in or close to the applicationarea.Terrestrial environment(soil-dwellingorganisms)Non-negligible (> LOC)No practical options available to reduce risks to soil-dwellingorganisms.Non-negligible.Operator exposure(mixing, loading,Non-negligible (> AOEL)No practical options available to reduce risks to operatorsduring mixing, loading or application..Non-negligible.Dichlorvos reassessment – application Page 83 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)application)Operator exposure(restricted entry)Non-negligible (> AOEL)Proposed Additional ContolNo practical options available to reduce risks to operatorsduring restricted entry.Modified Level ofRiskNon-negligible.7 - 8 Aquatic environment(invertebrates)Non-negligible (> LOC)No practical options available to reduce risk to aquaticinvertebrates.Non-negligible(High).Terrestrial environment(vertebrates)Terrestrial environment(invertebrates)Operator exposure(mixing, loading,application)Operator exposure(restricted entry)Non-negligible (> LOC) No practical options available to reduce risks to birds. Non-negligible(High).Non-negligible (> LOC)Non-negligible (> AOEL)Non-negligible (> AOEL)Restriction of the timing of application to avoidexposure of foraging bees.No practical options available to reduce risk to nontargetterrestrial invertebrates (in or close to theapplication area).No practical options available to reduce risks to operatorsduring mixing, loading or application.No practical options available to reduce risks to operatorsduring restricted entry.Non-negligible(High).Non-negligible.Non-negligible.Indoor use (industrial)9 - 10 Operator exposure(mixing, loading)Non-negligible(> AOEL)Automatic, remote application to ensure no operatorexposure during application;Restrict number of cylinder changes to 1 per operatorper day;Negligible.Prescribe minimum levels of PPE/RPE for connection /disconnection of cylinders:PPE:Dichlorvos reassessment – application Page 84 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Operator exposure(restricted entry)Non-negligible(> AOEL)Proposed Additional Contol- glovesRPE:- full-face respirator, with minimum specificationof A1P2.Application rates should be restricted to 0.05 g a.i. / m 3 ,in order for an REI to be set.Introduce REIs:- entry into treated glasshouse areas for anypurpose is prohibited for 4 hours after completionof application; and- restricted entry into treated glasshouse areas ispermitted after at least 4 hours has elapsed sincecompletion of application for ventilation tasksonly; and- restricted entry into treated glasshouse areas ispermitted after at least 4 hours has elapsed sincecommencement of ventilation for tending tasks;- restricted entry into treated mushroom houses ispermitted after at least 48 hours has elapsed sincecompletion of application for any task;- restricted entry into treated glasshouse areas ormushroom houses is permitted after at least 72hours has elapsed since commencement ofventilation for harvesting or other tasks thatinvolve contact with treated crops.Introduce PPE/RPE requirements for entry into treatedModified Level ofRiskNegligible.Dichlorvos reassessment – application Page 85 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Proposed Additional Contolglasshouse areas for ventilation tasks:PPE:- hood/visor,- overalls over long-sleeved shirt and long-leggedtrousers;- boots;- gloves.RPE:- full-face with minimum specification of A1P2, orair-hose respirator.Introduce PPE/RPE requirements for post-ventilationentry into treated glasshouse areas, or any tasks intreated mushroom houses:PPE:- hat and goggles,- overalls over long-sleeved shirt and long-leggedtrousers;- boots;- gloves.Introduce a maximum exposure time persons enteringtreated areas:- for ventilation tasks, < 30 minute / day;- for tending tasks, < 2 hours / day, until at least 72Modified Level ofRiskDichlorvos reassessment – application Page 86 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Proposed Additional Contolhours has elapsed since completion ofapplication;- for any tasks in mushroom houses, < 2 hours /day, until at least 72 hours has elapsed sincecompletion of application.Modified Level ofRisk11 – 12 Operator exposure(mixing, loading)Non-negligible(> AOEL)Automatic, remote application to ensure no operatorexposure during application;Maximum quantity to be mixed per operator per day,equivalent to 56 g dichlorvos;Non-negligibleIntroduce PPE/RPE requirements for use by operators:Mixing/loadingPPE:- glovesRPE:- half-face respirator with minimum specificationof A1P2.Operator exposure(restricted entry)Non-negligible(> AOEL)Application rates should be restricted to 0.05 g a.i. / m 3 ,in order for an REI to be set.NegligibleIntroduce REIs:- restricted entry into treated glasshouse areas ispermitted after at least 4 hours has elapsed sincecompletion of application for ventilation tasksonly; and- restricted entry into treated glasshouse areas ispermitted after at least 4 hours has elapsed sinceDichlorvos reassessment – application Page 87 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Proposed Additional Contolcommencement of ventilation for tending tasks;- restricted entry into treated mushroom houses ispermitted after at least 48 hours has elapsed sincecompletion of application for any task;- restricted entry into treated glasshouse areas ormushroom houses is permitted after at least 72hours has elapsed since commencement ofventilation for harvesting or other tasks thatinvolve contact with treated crops.Introduce PPE/RPE requirements for entry into treatedglasshouse areas for ventilation tasks:PPE:- hood/visor,- overalls over long-sleeved shirt and long-leggedtrousers;- boots;- gloves.RPE:- full-face with minimum specification of A1P2, orair-hose respirator.Introduce PPE/RPE requirements for post-ventilationentry into treated glasshouse areas, or any tasks intreated mushroom houses:PPE:Modified Level ofRiskDichlorvos reassessment – application Page 88 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Proposed Additional Contol- hat and goggles,- overalls over long-sleeved shirt and long-leggedtrousers;- boots;- gloves.Modified Level ofRiskIntroduce a maximum exposure time persons enteringtreated areas:- for ventilation tasks, < 30 minute / day;- for tending / harvesting tasks, < 2 hours / day,until at least 72 hours has elapsed sincecompletion of application.;- for any tasks in mushroom houses, < 2 hours /day, until at least 72 hours has elapsed sincecompletion of application.13 - 14 Operator exposure(mixing, loading)Negligible(> AOEL)Automatic, remote application to ensure no operatorexposure during application;Negligible.Maximum quantity to be mixed per operator per day,equivalent to 56 g dichlorvos;Introduce PPE/RPE requirements for use by operators:Mixing/loadingPPE:- glovesRPE:Dichlorvos reassessment – application Page 89 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Operator exposure(restricted entry)Non-negligible(> AOEL)Proposed Additional Contol- half-face respirator with minimum specificationof A1P2.Application rate should be restricted to 0.05 g a.i. / m 3 ,in order for an REI to be set.Introduce REIs:- entry into treated glasshouse areas for anypurpose is prohibited for 4 hours after completionof application; and- restricted entry into treated glasshouse areas ispermitted after 4 hours has elapsed sincecompletion of application for ventilation tasksonly; and- restricted entry into treated glasshouse areas ispermitted after at least 4 hours has elapsed sincecommencement of ventilation for tending tasks;- restricted entry into treated glasshouse areas ispermitted after at least 72 hours has elapsed sincecommencement of ventilation for harvesting orother tasks that involve contact with treatedcrops.Introduce PPE/RPE requirements for entry into treatedglasshouse areas for ventilation tasks:PPE:- hood/visor,- overalls over long-sleeved shirt and long-leggedtrousers;Modified Level ofRiskNegligible.Dichlorvos reassessment – application Page 90 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Proposed Additional Contol- boots;- gloves.RPE:- full-face with minimum specification of A1P2, orair-hose respirator.Introduce PPE/RPE requirements for post-ventilationentry into treated glasshouse areas:PPE:- hat and goggles,- overalls over long-sleeved shirt and long-leggedtrousers;- boots;- gloves.Introduce a maximum exposure time persons enteringtreated areas:- for ventilation tasks, < 30 minute / day;- for tending / harvesting tasks, < 1 hours / dayuntil at least 72 hours has elapsed sincecompletion of application.Modified Level ofRisk15, 16 Operator exposure(mixing, loading,application)Non-negligible (> AOEL)No practical options available to reduce risks to operatorsduring mixing, loading or application.Non-negligible.Operator exposure Non-negligible (> AOEL) No REI can be set for these Use Scenarios, based on an Non-negligible.Dichlorvos reassessment – application Page 91 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Proposed Additional Contol(restricted entry) application rate of 0.7 g a.i./m 3 .17, 18 Operator exposure(mixing, loading)Non-negligible(> AOEL)Automatic, remote application to ensure no operatorexposure during application;Restrict number of cylinder changes to 1 per operatorper day.Prescribe minimum levels of PPE/RPE for connection /disconnection of cylinders:PPE:- glovesRPE:- full-face respirator, with minimum specificationof A1P2.Modified Level ofRiskNegligibleOperator exposure(restricted entry)Non-negligible(> AOEL)Application rates should be restricted to 0.15 g a.i. / m 3 ,in order for an REI to be set.Negligible.Introduce REIs:- entry into treated areas is prohibited for 10 hoursafter completion of application; and- restricted entry into treated glasshouse areas ispermitted after at least 10 hours has elapsed sincecompletion of application for ventilation tasksonly; and- unrestricted entry into buildings treated at ratesup to 0.05 g a.i. / m 3 for other tasks is permittedafter at least 72 hours after commencement ofventilation;Dichlorvos reassessment – application Page 92 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Proposed Additional Contol- unrestricted entry into buildings treated at ratesabove 0.05 g a.i. / m 3 , up to 0.15 g a.i. / m 3 forother tasks is permitted after at least 120 hoursafter commencement of ventilation.Introduce minimum PPE/RPE requirements for entryinto treated buildings for ventilation tasks:RPE:- half-face respirator with minimum specificationof A1P2;Introduce a maximum exposure time for entry intotreated area:- for ventilation tasks, < 30 minute/ day.Modified Level ofRisk19 Operator exposure(mixing, loading,application)Non-negligible(> AOEL)Introduce maximum treated area of 3750 m 3 peroperator per day;Restrict number of cylinder changes to 1 per operatorper day.Negligible.Prescribe minimum levels of PPE/RPE:Connection / disconnection of cylindersPPE:- glovesRPE:- full-face respirator, with minimum specificationof A1P2.Dichlorvos reassessment – application Page 93 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Proposed Additional ContolApplicationPPE:- chemical resistant overalls;- boots;- glovesRPE:- air-hose respirator.Modified Level ofRiskOperator exposure(restricted entry)Non-negligible(>AOEL)Application rates should be restricted to 0.15 g a.i. / m 3 ,in order for an REI to be set.Negligible.Introduce a REIs:- entry into treated areas is prohibited for 10 hoursafter completion of application; and- restricted entry into treated glasshouse areas ispermitted after at least 10 hours has elapsed sincecompletion of application for ventilation tasksonly; and- unrestricted entry for other tasks in buildingstreated at 0.05 g a.i. / m 3 is permitted 72 hoursafter commencement of ventilation; and- unrestricted entry for other tasks in buildingstreated at 0.15 g a.i. / m 3 is permitted 120 hoursafter commencement of ventilation.Introduce minimum PPE/RPE requirements for entryinto treated buildings for ventilation tasks:Dichlorvos reassessment – application Page 94 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Proposed Additional ContolRPE:- half-face respirator with minimum specificationof A1P2;Modified Level ofRiskIntroduce a maximum exposure time for entry intotreated area:- for ventilation tasks, < 30 minute/ day.20 - 21 Operator exposure(mixing, loading)Non-negligible(> AOEL)Automatic, remote application to ensure no operatorexposure during application;Negligible.Maximum quantity to be mixed per operator per day,equivalent to 56 g dichlorvos;Introduce PPE requirements:PPE:- GlovesRPE:- Half-face respirator with minimum specificationof A1P2.Operator exposure(restricted entry)Non-negligible(> AOEL)Application rates should be restricted to 0.15 g a.i. / m 3 ,in order for an REI to be set.Negligible.Introduce a REIs:- entry into treated areas is prohibited for 10 hoursafter completion of application; and- restricted entry into treated glasshouse areas ispermitted after at least 10 hours has elapsed sincecompletion of application for ventilation tasksDichlorvos reassessment – application Page 95 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Proposed Additional Contolonly; and- unrestricted entry into buildings treated at 0.05 ga.i. / m 3 is permitted after at least 72 hours aftercommencement of ventilation; and- unrestricted entry into buildings treated at 0.15 ga.i. / m 3 is permitted after at least 120 hours aftercommencement of ventilation.Introduce minimum PPE/RPE requirements for entryinto treated buildings for ventilation tasks:RPE:- half-face respirator with minimum specificationof A1P2;Modified Level ofRiskIntroduce a maximum exposure time for entry intotreated area:- for ventilation tasks, < 30 minute/ day.22 - 23 Operator exposure(mixing, loading,application)Non-negligible(> AOEL)Introduce a maximum application rates 0.15 g a.i. / m 3 ;Introduce a maximum quantity to be mixed per operatorper day, equivalent to 56 g dichlorvos;Negligible.Introduce a maximum treated volume of 375 m 3 peroperator per day;Introduce PPE / RPE requirements:Mixing/loadingPPE:- GlovesDichlorvos reassessment – application Page 96 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Proposed Additional ContolRPE:- Half-face respirator with minimum specificationof A1P2.ApplicationPPE:- Chemical resistant overalls;- Boots;- GlovesRPE:- Half-face respirator with minimum specificationof A1P2.Modified Level ofRiskOperator exposure(restricted entry)Non-negligible(> AOEL)Introduce a REIs:- entry into treated areas is prohibited for 10 hoursafter completion of application; andNegligible.- restricted entry into treated glasshouse areas ispermitted after at least 10 hours has elapsed sincecompletion of application for ventilation tasksonly; and- unrestricted entry into buildings treated at 50 mg/ m 3 is prohibited until at least 72 hours aftercommencement of ventilation; and- unrestricted entry into buildings treated at 150mg / m 3 is prohibited until at least 120 hours aftercommencement of ventilation.Dichlorvos reassessment – application Page 97 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Proposed Additional ContolIntroduce minimum PPE/RPE requirements for entryinto treated buildings for ventilation tasks:RPE:- half-face respirator with minimum specificationof A1P2;Modified Level ofRiskIntroduce a maximum exposure time for entry intotreated area:- for ventilation tasks, < 30 minute/ day.24, 25 Operator exposure(mixing, loading,application)Non-negligible(> AOEL)Introduce a maximum application rate of 0.3 g a.i. / m 2 ;Introduce a maximum quantity to be mixed per operatorper day, equivalent to 56 g dichlorvos;Negligible.Introduce a maximum treated volume of 150 m 2 peroperator per day and equivalent mixing/loadingquantity;Introduce PPE/RPE requirements:Mixing, loading, application:PPE:- Chemical resistant overalls;- Boots;- GlovesRPE:- Air-hose RPE.Dichlorvos reassessment – application Page 98 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Operator exposure(restricted entry)Indoor use (domestic use)Non-negligible(> AOEL)Proposed Additional ContolIntroduce a REIs:- entry into treated areas is prohibited for 10 hoursafter completion of application; and- restricted entry into treated glasshouse areas ispermitted after at least 10 hours has elapsed sincecompletion of application for ventilation tasksonly; and;- unrestricted entry into treated buildings for othertasks is prohibited until at least 120 hours aftercommencement of ventilation;Introduce minimum PPE/RPE requirements for entryinto treated buildings for ventilation tasks:RPE:- half-face respirator with minimum specificationof A1P2;REI:- half-face respirator with minimum specificationof A1P2.Introduce a maximum exposure time for entry intotreated area:- for ventilation, < 30 minute/ day.Modified Level ofRiskNegligible.26 - 27 Operator exposure(mixing, loading,application)Non-negligible(> AOEL)Restrict use to commercial use only, and in industriallocations only – remove exemption for approvedhandler requirements;Negligible.Dichlorvos reassessment – application Page 99 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Proposed Additional Contol[PPE: unlikely to be used in a domestic setting]Introduce a maximum application rate of 0.3 g a.i. / m 2 ;Introduce a maximum treated volume of 150 m 2 peroperator per day and equivalent mixing/loadingquantity;Introduce PPE requirements:Mixing, loading, application:PPE:- Chemical resistant overalls;- Boots;- GlovesRPE:- Air-hose RPE.Modified Level ofRiskOperator exposure(restricted entry)Non-negligible(> AOEL)Introduce a REIs:- entry into treated areas is prohibited for 10 hoursafter completion of application; andNegligible- restricted entry into treated glasshouse areas ispermitted after at least 10 hours has elapsed sincecompletion of application for ventilation tasksonly; and- unrestricted entry into treated buildings for othertasks is prohibited until at least 120 hours aftercommencement of ventilation.Dichlorvos reassessment – application Page 100 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Proposed Additional ContolIntroduce minimum PPE/RPE requirements for entryinto treated buildings for ventilation tasks:RPE:- half-face respirator with minimum specificationof A1P2;REI:- Half-face respirator with minimum specificationof A1P2.Modified Level ofRiskIntroduce a maximum exposure time for entry intotreated area:- for ventilation, < 30 minute/ day.Bystander exposureNon-negligible(> AOEL)ERMA New Zealand is unable to determine an REI fordomestic usage.Non-negligibleNo practical options available to reduce risks to childrenentering treated areas.Outdoor use (domestic use)28 - 29 Operator exposure(mixing, loading,application)Non-negligible(> AOEL)Restrict use to commercial use only, and in industriallocations only – remove exemption for approvedhandler requirements;[PPE: unlikely to be used in a domestic setting]Negligible.Introduce a maximum application rate of 0.3 g a.i. / m 2 ;Introduce a maximum treated volume of 150 m 2 peroperator per day and equivalent mixing/loadingquantity;Dichlorvos reassessment – application Page 101 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Proposed Additional ContolIntroduce PPE requirements:Mixing, loading, application:PPE:- Chemical resistant overalls;- Boots;- GlovesRPE:- Air-hose RPE.Modified Level ofRiskOperator exposure(restricted entry)Non-negligible(> AOEL)Introduce a REIs:- entry into treated areas is prohibited for 10 hoursafter completion of application; andNegligible- restricted entry into treated glasshouse areas ispermitted after at least 10 hours has elapsed sincecompletion of application for tasks that do notinvolve contact with treated areas;- unrestricted entry into treated buildings for othertasks is prohibited until at least 120 hours aftercompletion of application;Introduce minimum PPE/RPE requirements for entryinto treated buildings for ventilation tasks:RPE:- half-face respirator with minimum specificationof A1P2;Dichlorvos reassessment – application Page 102 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Proposed Additional ContolREI:- Half-face respirator with minimum specificationof A1P2.Modified Level ofRiskIntroduce a maximum exposure time for entry intotreated area:- for tasks within 120 hours of completion ofapplication, < 30 minute/ day.Bystander exposureNon-negligible(> AOEL)ERMA New Zealand is unable to determine an REI fordomestic usage.Non-negligibleNo practical risk reduction options available.Outdoor use (public spaces)30 Aquatic environment Non-negligible (> LOC) Restrict to automated or handheld fogging equipment.Operator exposure(mixing, loading,Avoid run-off contamination of aquatic systems:- Do not apply under meteorological conditions orfrom spray equipment that could be expected tocause spray drift onto natural streams, rivers orwaterways;- Avoid excess spraying causing run-off fromtreated surfaces into untreated areas;- Allow treated areas to dry before washing (orirrigating);- Do not apply to exposed areas if rain is expectedwithin 4 hours.NegligibleNon-negligible Restrict to automated or handheld fogging equipment; NegligibleDichlorvos reassessment – application Page 103 of 436

Use Scenario Receptor Level of Risk (with existingcontrols in place)Proposed Additional ContolModified Level ofRiskapplication) (> AOEL) Maximum treatment area of 150 m 2 per operator perday and equivalent mixing/loading quantity.Operator and bystanderexposure(restricted entry)Non-negligible(> AOEL)ERMA New Zealand is unable to determine an REI for publicspace usage.Non-negligibleBiosecurity fruit fly monitoring programme31 Operator exposure(application/retrieval/checking)Non-negligibleIntroduce minimum PPE/RPE requirements for tasksinvolving dichlorvos-containing strips:PPENegligible- gloves;- handled strips with forceps..RPE- half-face respirator, with minimum specificationof A1P2.Restrict the number of strips handled / traps serviced byoperators per day to 90.Guidance (e.g. SOP) to be provided to operators byregistrants regarding carriage of DDVP strips andsachets.Bystander exposure Non-negligible Introduce additional labelling requirements on the trapsidentifying a potential inhalation risk.NegligibleDichlorvos reassessment – application Page 104 of 436

SECTION 7 – OVERALL EVALUATION7.1 Evaluation of options to reduce risk by restricting use7.1.1 In the absence of exposure information, ERMA New Zealand has used quantitativeexposure assessment models to determine the levels of risk to human health and theenvironment. This exposure modelling has produced indicative levels of risk that, inmany cases, are high.7.1.2 On the basis of this information, ERMA New Zealand‘s interim evaluation is thatthere are significant (non-negligible) risks associated with the use of dichlorvos inNew Zealand which outweigh the benefits and need to be managed. Most notably:risks posed to the aquatic environment;risks to birds;risks to non-target invertebrates;risks to operators;risks to bystanders.7.1.3 ERMA New Zealand notes that use of substances would be based on alternativeactive ingredients if the use of dichlorvos was restricted or prohibited:Potential alternatives have been identified for some agricultural uses ofdichlorvos and the hazards of these are shown in Table 14; many have a lowerhazard profile.For some crop/pest combinations no alternatives have been identified.Nevertheless, all the crops on which dichlorvos is used in New Zealand aregrown overseas in countries that do not use dichlorvos in plant protectionproducts.7.1.4 ERMA New Zealand also notes that there are particular benefits associated with theuse of dichlorvos, notably:dichlorvos has a different mode of action to other products that may be used ifits use is restricted or prevented. Maintaining a suite of products with differentmodes of action is an important means of reducing the likelihood ofdevelopment of pest resistance:dichlorvos possesses a unique combination of physical and chemical propertiesthat can provide rapid knock-down of pests, with short withholding periods,and can be used close to harvest, where other products might be precluded:dichlorvos used in the biosecurity fruit fly monitoring programme, which hassignificant economic significance, and for which no alternatives have beenidentified.7.1.5 ERMA New Zealand notes that the comparison of risks or benefits, for example arisk of chronic human toxic effects compared to a risk of aquatic toxic effects, andthe comparison of risks and benefits, for example an environmental or human healthrisk to a societal or economic benefit, requires value judgement. This is taken intoaccount in making recommendations (Section 6.1) and the Authority will take thisinto account in reaching an overall assessment of the risks and benefits.7.1.6 This evaluation takes into account that ERMA New Zealand‘s assessment is basedon the information that is available to it. Additional information is welcomed. ERMANew Zealand invites submitters to provide additional information that they mightDichlorvos reassessment – application Page 105 of 436

have, and notes the following as areas where additional information may beparticularly useful:the level of benefit offered by dichlorvos substances, especially regardingsocial effects from the use of dichlorvos (e.g. effect on local employmentopportunities and direct/indirect local community impact arising fromdichlorvos use);the level of ecomonic benefit provided to the public health sector bydichlorvos;the financial implications of overseas restrictions on crops treated withdichlorvos;identification of the use and availability of alternative substances, withparticular regard to dichlorvos use in non-agricultural enclosed space use;identification of use patterns that have not been included in the assessment;provision of data to determine when unrestricted entry into treated glasshousesor mushroom houses can occur;identification of minimum effective application rates, which may be used torefine the exposure assessment;feasibility of proposed risk management measures, and the implications of themodified control regime (such as financial implications of installing orupgrading application equipment).7.1.7 ERMA New Zealand notes that the Authority must consider the costs and benefits ofvaried or additional controls, in accordance with clause 35 of the Methodology 7 . Ifthe recommendations from this assessment are adopted there may be additional costsrequired to users arising from a need to upgrade existing or install new equipment inorder to continue to use dichlorvos for certain uses. The net level of benefit may bereduced as a result. ERMA New Zealand invites submitters to provide informationrelating to the cost implications of adopting the proposed recommendations.7.1.8 Although some information on these matters has been provided to ERMA NewZealand in the course of preparing this application, the statutory public submissionsperiod allows a further opportunity for information to be provided which could resultin the Authority establishing a higher level of risks, costs or benefits.7.1.9 Clauses 29 and 30 of the Methodology provides that where there is scientific andtechnical uncertainty, the Authority must consider the materiality of the uncertaintyand if it cannot be resolved to its satisfaction, the Authority must take into accountthe need for caution in managing the adverse effects of the substance.7.1.10 Given the information currently before it and taking account of the need for caution,ERMA New Zealand makes the preliminary recommendations set out in Section 7.4.7Hazardous Substances and New Organisms (Methodology) Order 1998 (SR 1998/217).Dichlorvos reassessment – application Page 106 of 436

7.2 Overall Evaluation7.2.1 A summary of the risks, benefits and overall proposals for the Use Scenarios fordichlorvos-containing substances are details in Table 17, Table 18 and Table 19.7.2.2 Outcome Scenario (c) means that, while the unavailability of dichlorvos means thatthe level of adverse effects is regarded as non-existent, the level of benefit that mayarise from its availability can also not be realised. This is classed as an absence ofbenefit, rather than an adverse effect.Table 17.Summary of risks for Use Scenarios and Outcome Scenarios fordichlorvos-containing substances.UseScenarioOutcomeScenario (a)(continued use)1 - 8 Environmental:Non-negligibleHuman Health:Non-negligible9 – 29, 31 Environmental:NegligibleHuman Health:Non-negligible30 Environmental:Non-negligibleHuman Health:Non-negligible32 Environmental:NegligibleHuman Health:NegligibleOutcomeScenario (b)(restricteduse/additionalcontrols)Environmental:Non-negligibleHuman Health:Non-negligibleEnvironmental:Human Health:Environmental:Human Health:NegligibleNegligibleNegligibleNon-negligibleEnvironmental:Human Health:NegligibleNegligibleOutcomeScenario (c)(withdrawn –reliance onalternatives)Environmental:Human Health:Environmental:Human Health:Environmental:Human Health:Environmental:Human Health:NoneNoneNoneNoneNoneNoneNoneNoneDichlorvos reassessment – application Page 107 of 436

Table 18Summary of benefits associated with scenarios.Receptor(Use Scenario)Human health(All UseScenarios)Environment(All UseScenarios)Relationship ofMāori to theenvironment(All UseScenarios)OutcomeScenario (a)(continued use)OutcomeScenario (b)(restricteduse/additionalcontrols)OutcomeScenario (c)(withdrawn –reliance onalternatives)Negligible Negligible NoneNegligible Negligible NoneNegligible Negligible NoneSociety andCommunities:Agricultural use(Use Scenarios1 to 16)Public health use(Use Scenarios17 to 30)Biosecurity use(Use Scenario31)MarketEconomy:Agricultural use(Use Scenarios1 to 16)Public health use(Use Scenarios17 to 29)(Use Scenario30)Biosecurity use(Use Scenario31)Negligible Negligible NoneNon-negligible(Low)Non-negligible(Low)NoneNegligible Negligible NoneNon-negligible(Low)Non-negligible(v. Low)Non-negligible(Low)Non-negligible(v. Low)NoneNoneNegligible Negligible NoneNon-negligible(Low to medium)Non-negligible(Low to medium)NoneDichlorvos reassessment – application Page 108 of 436

Table 19.Overall evaluation – summary of combined non-negligible effects.UseScenariosAssessment ofEffectOutcomeScenario (a)(continued use)OutcomeScenario (b)(restricted use/additionalcontrols)OutcomeScenario (c)(discontinued use)Outdoor agricultural usage (HSNO Approvals HSR000211, HSR000213)1 - 8Adverse (-ve) Non-negligible Non-negligible NonePositive (+ve) Non-negligible Non-negligible NoneOverall -ve ≥ +ve -ve ≥ +ve Enclosed space, agricultural usage (HSNO Approvals HSR000211, HSR000212,HSR000213)9 - 16Adverse (-ve) Non-negligible Negligible NonePositive (+ve) Non-negligible Non-negligible NoneOverall -ve ≥ +ve -ve < +veEnclosed space, industrial usage (HSNO Approvals HSR000211, HSR000212,HSR000213)17 - 25Adverse (-ve) Non-negligible Negligible NonePositive (+ve) Non-negligible Non-negligible NoneOverall -ve ≥ +ve -ve < +veEnclosed space, domestic usage (HSNO Approvals HSR000207, HSR000209)26 - 29Adverse (-ve) Non-negligible Negligible NonePositive (+ve) Non-negligible Non-negligible NoneOverall -ve ≥ +ve -ve < +veOutdoor public space usage (HSNO Approvals HSR000211, HSR000213)30Adverse (-ve) Non-negligible Non-negligible NonePositive (+ve) Non-negligible Non-negligible NoneOverall -ve ≥ +ve -ve ≥ +ve Biosecurity use (HSNO Approval HSR000126)31Adverse (-ve) Non-negligible Negligible NonePositive (+ve) Non-negligible Non-negligible NoneOverall -ve ≥ +ve -ve < +veManufacture for export (HSNO Approval HSR001757)32Dichlorvos reassessment – application Page 109 of 436-ve > +veAdverse (-ve) Negligible Negligible NonePositive (+ve) Negligible Negligible NoneOverall-ve ≤ +ve

UseScenariosAssessment ofEffectOutcomeScenario (a)OutcomeScenario (b)OutcomeScenario (c)(continued use)(restricted use/additionalcontrols)(discontinued use)Notes:Proposed Outcome Scenario7.3 Proposed additions and modifications to controls undersection 77A7.3.1 The Outcome Scenarios have been evaluated for individual Use Scenarios. A singleapproval may contain numerous Use Scenarios. Additional controls have beenproposed for particular Use Scenarios and are therefore appropriate for the associatedapprovals. The Use Scenarios are applicable to specific approvals for dichlorvoscontainingsubstances.7.3.2 Applying the Outcome Scenarios to the relevant approvals for dichlorvos anddichlorvos-containing substances results in the following proposals for variations tothe conditions for each approval.7.3.3 Given the diverse use patterns for individual approvals, Outcome Scenario (b)includes withdrawal of specific Use Scenarios. The approval conditions, overall,would be restricted, but individual Use Scenarios may be discontinued. In order foran approval to be discontinued, all of the individual Use Scenarios would need to bediscontinued. Table 20 summarises the Outcome Scenarios for each substanceapproval containing dichlorvos.Table 20.Outcome Scenarios for approvals. “Restricted use” includeswithdrawal of specific Use Scenarios.ApprovalnumberSubstanceDescriptionOutcomeScenario (a)OutcomeScenario (b)OutcomeScenario (c)(continued use)(restricted use /additionalcontrols)(discontinueduse)HSR002838Dichlorvos[CAS #62-73-7]HSR000212Aerosolcontaining 50 g/kgdichlorvosHSR000211Emulsifiableconcentratecontaining 1000g/litre dichlorvosHSR000213Emulsifiableconcentratecontaining 1140g/litre dichlorvosDichlorvos reassessment – application Page 110 of 436

ApprovalnumberSubstanceDescriptionOutcomeScenario (a)OutcomeScenario (b)OutcomeScenario (c)(continued use)(restricted use /additionalcontrols)(discontinueduse)HSR000207HSR000209HSR000126Flammableaerosol containing3.1 g/litredichlorvos and 8.7g/litre propoxurReady to useliquid containing4.4 g/litredichlorvos and 9.6g/litre propoxurDDVP InsecticideStripHSR001757 J72.03 Notes:Proposed Outcome Scenario7.3.4 The diverse usage of dichlorvos means that multiple Use Scenarios may apply toeach approval, and individual Use Scenarios may apply to multiple approvals.7.3.5 ERMA New Zealand proposes that the use of dichlorvos is restricted as follows:Use of dichlorvos that is not in accordance with label instructions is prohibited.Dichlorvos, when applied as a spray, fog or aerosol, may be applied in indoorcommercial or industrial locations only.Maximum application rates, maximum treatment areas or volumes, maximumdaily limits for operator dichlorvos handling (including mixing/loading,connection of cylinders, application of dichlorvos strips) are specified.PPE/RPE requirements are specified for various stages of the substance‘slifecycle.Entry into treated areas must be in accordance with the restricted entryintervals (REIs) and conditions specified.7.3.6 The specific proposals for each approval are detailed in Table 21. The appropriateUse Scenarios in Table 16 should be referred to, in order to provide details of thevariations that apply to the dichlorvos approvals. In the interests of clarity, thespecific details have not been reproduced here.Table 21.Summary of the proposed variations to approvals for dichlorvos anddichlorvos-containing substances.Substance detailsHSR002838Dichlorvos[CAS #62-73-7]Proposed variationsNo variations to existing conditions proposed.Dichlorvos reassessment – application Page 111 of 436

Substance detailsHSR000126DDVPInsecticide StripUse Scenario31HSR000207Flammableaerosolcontaining 3.1g/litre dichlorvosand 8.7 g/litrepropoxurUse Scenarios26-27HSR000209Ready to useliquid containing4.4 g/litredichlorvos and9.6 g/litrepropoxurUse Scenarios28-29HSR000211Emulsifiableconcentratecontaining 1000g/litre dichlorvosUse Scenarios1-8,11-16,20-25,30Proposed variations1. Use that is not in accordance with the label instructionsis prohibited;2. Introduce PPE requirements for operators;3. Restrict the number of strips handled / traps serviced byoperators per day;4. Labelling requirements to identify the inhalation risk;5. Provision of guidance material for transportation and useof DDVP Strips.1. Use that is not in accordance with the label instructionsis prohibited;2. Restrict use to industrial sites and by commercialapplicators only – approved handler exemption removed;3. Introduce PPE/RPE requirements;4. Application methods to be restricted to remote,automatic delivery systems;5. Introduce maximum application rates and treatmentareas;6. Introduce a restricted entry intervals;7. Introduce a maximum exposure time for entry intotreated area.1. Use that is not in accordance with the label instructionsis prohibited;2. Restrict use to industrial sites and by commercialapplicators only – approved handler exemption removed;3. Introduce PPE/RPE requirements;4. Application methods to be restricted to remote,automatic delivery systems;5. Introduce maximum application rates and treatmentareas;6. Introduce a restricted entry intervals;7. Introduce a maximum exposure time for entry intotreated area.1. Use that is not in accordance with the label instructionsis prohibited;2. Outdoor agricultural or public area use is prohibited;3. Application methods to be restricted to remote,automatic delivery systems, or limited manual handspraying;4. Apply a maximum quantity that an individual maymix/load per day;5. Introduce maximum application rates;6. Introduce PPE/RPE requirements;7. Introduce a restricted entry intervals;Dichlorvos reassessment – application Page 112 of 436

Substance detailsHSR000212Aerosolcontaining 50g/kg dichlorvosUse Scenarios9-10, 17-19HSR000213Emulsifiableconcentratecontaining 1140g/litre dichlorvosUse Scenarios1-8,11-16,20-25,30HSR001757J72.03Use Scenarios32Proposed variations8. Introduce a maximum exposure time for entry intotreated area.1. Use that is not in accordance with the label instructionsis prohibited;2. Introduce PPE/RPE requirements for connection /disconnection of cylinders, and entry into treated areas;3. Restrict number of cylinder changes per operator perday;4. Introduce maximum application rates;5. Introduce a maximum daily treatment volume peroperator per day for manual application;6. Introduce a restricted entry intervals;7. Introduce a maximum exposure times for entry intotreated area for different tasks.1. Use that is not in accordance with the label instructionsis prohibited;2. Outdoor agricultural or public area use is prohibited;3. Application methods to be restricted to remote,automatic delivery systems, or limited manual handspraying;4. Apply a maximum quantity that an individual maymix/load per day;5. Introduce PPE/RPE requirements;6. Introduce maximum application rates;7. Introduce a restricted entry intervals;8. Introduce a maximum exposure time for entry intotreated area.No variations to existing conditions proposed.7.3.7 ERMA New Zealand has considered risk management options for use of dichlorvosformulations and concluded that certain risks can be adequately managed byenhanced controls, such as:risks to the health of operators can be managed by prescription of PPE/RPE;anduse, application and restricted entry intervals restrictions.7.3.8 Other risks cannot be adequately managed by realistic controls:buffer zones, greater than can be determined by the modelling undertaken (i.e.in excess of 300 m) would be required around water bodies and these are notconsidered to be practical;Dichlorvos reassessment – application Page 113 of 436

Table 22.there are no practicable risk reduction measures to protect birds or non-targetinvertebrates;exposure risks to children returning to treated locations.7.3.9 ERMA New Zealand has assessed exposures based on specific usage informationavailable to it during its evaluation. The details of recommendations based on thisusage information (such as application rates and methods, or PPE/RPE requirements)will reflect the criteria used to carry out the assessment.7.3.10 ERMA New Zealand considers that, if the proposed additional controls andrestrictions are accepted, a phase-in period of 12 months should also be adopted togive affected parties time to accommodate the revised conditions.7.3.11 ERMA New Zealand proposes that the classifications for dichlorvos and dichlorvoscontainingsubstances should be modified as detailed in Table 22.Summary of proposed hazard classifications for dichlorvos and dichlorvos-containingsubstances.Hazard ClassDichlorvosReady touse liquidcontaining4.4 g/ldichlorvos& 9.6 g/lpropoxurEmulsifiableconcentratecontaining1000 g/ldichlorvosAerosolcontaining50 g/kgdichlorvosEmulsifiableconcentratecontaining1140 g/ldichlorvosFlammableaerosolcontaining3.1 g/ldichlorvosand 8.7 g/lpropoxurDichlorvos reassessment – application Page 114 of 436DDVPinsecticidestripApproval # HSR002838 HSR000209 HSR000211 HSR000212 HSR000213 HSR000207 HSR000126 HSR001757Flammability No No No No 2.1.2A No No NoAcute toxicityN/A,N/A,6.1B 6.1D 6.1C6.1C(oral)aerosolaerosol6.1D 6.1CAcute toxicity(dermal)6.1B 6.1E 6.1B 6.1D 6.1B No 6.1E 6.1CAcute toxicity(inhalation)6.1B No 6.1B 6.1C 6.1C No 6.1C 6.1BSkinirritancy/corrosion6.3B 6.3B 6.3B No 6.3B 6.3B 6.3B 6.3BEyeirritancy/corrosion6.4A 8.3A 6.4A No 6.4A 6.4A 6.4A 6.4AContactsensitisation6.5B 6.5B 6.5B 6.5B 6.5B 6.5B 6.5B 6.5BMutagenicity 6.6B No 6.6B 6.6B 6.6B ND 6.6B 6.6BCarcinogenicity 6.7B 6.7B 6.7B 6.7B 6.7B 6.7B 6.7B 6.7BReproductive/developmentalNo No 6.8A No ND ND ND NotoxicityTarget organsystemic toxicity6.9A 6.9B 6.9A 6.9B 6.9A 6.9B 6.9A 6.9AAquaticecotoxicity9.1A 9.1A 9.1A 9.1A 9.1A 9.1A 9.1A 9.1ASoil ecotoxicity 9.2D No 9.2D No 9.2D ND ND NDTerrestrialvertebrate9.3A 9.3B 9.3A 9.3B 9.3A 9.3B 9.3B 9.3BecotoxicityTerrestrialinvertebrateecotoxicity9.4A 9.4B 9.4A 9.4A 9.4A 9.4B 9.4A 9.4AJ72.03

7.3.12 In preparing this application, ERMA New Zealand has not conducted a specificMāori consultation but the impression gained from hui with iwi/Māori resourcemanagers is that unless substances provide clear benefits to outweigh potential risk,they generally oppose the ongoing use of hazardous substances. In the absence offurther information regarding benefits, it is expected that submissions from Māoriwould seek the revocation of the approvals for dichlorvos and its formulations.7.3.13 Clauses 29 and 30 of the Methodology 8 provides that where there is scientific andtechnical uncertainty, the Authority must consider the materiality of the uncertaintyand if it cannot be resolved to its satisfaction, the Authority must take into accountthe need for caution in managing the adverse effects of the substance.7.3.14 Given the information currently before it and taking account of the need for caution,ERMA New Zealand makes the preliminary recommendations set out in Section 7.4.8Hazardous Substances and New Organisms (Methodology) Order 1998 (SR 1998/217).Dichlorvos reassessment – application Page 115 of 436

7.4 Preliminary Recommendations7.4.1 ERMA New proposes the revised classifications (Table 22) are adopted fordichlorvos and dichlorvos-containing substances.7.4.2 Discontinue Use (Outcome Scenario (c)) is proposed for outdoor agricultural andpublic area uses.7.4.3 Continue Use (Outcome Scenario (a)) is proposed for dichlorvos (approval numberHSR002838).7.4.4 Continue Use (Outcome Scenario (a)) is proposed for J72.03 (approval numberHSR001757).7.4.5 Restrict Use / Additional Controls (Outcome Scenario (b)) is proposed for thefollowing dichlorvos-containing substances:DDVP Insecticide Strip (approval number HSR000126);Flammable aerosol containing 3.1 g/litre dichlorvos and 8.7 g/litre propoxur(approval number HSR000207);Ready to use liquid containing 4.4 g/litre dichlorvos and 9.6 g/litre propoxur(approval number HSR000209);Emulsifiable concentrate containing 1000 g/litre dichlorvos (approval numberHSR000211);Aerosol containing 50 g/kg dichlorvos (approval number HSR000212);Emulsifiable concentrate containing 1140 g/litre dichlorvos (approval numberHSR000213).7.4.6 ERMA New Zealand proposes that these recommendations are phased-in over a 12month period.Signed_______________________________________Chief Executive, ERMA New Zealand.Dated ____________23 November 2010____________Dichlorvos reassessment – application Page 116 of 436

Table A.2:Methods of analysisAnalytical methods for the active ingredient (ai)Technical ai(principle of method)Impurities intechnical ai(principle of method)Dichlorvos as technical product can be determined according toaccepted analytical methods. A generally accepted method isthe product analysis by reaction with excess of iodine that isestimated by tritation. This method is described in CIPACHandbook 1980,1A,1214. Another method is gaschromatography (GLC), which is described in CIPACProceedings, 1981,3,173. Procedures are described for theanalysis of dichlorvos technical by infrared spectroscopy and byan iodometric method: IR or GC/FID (method AW1/5)GC/FID (Denka method no.31) not validatedAnalytical methods were described for the determination oforganic and additional by-products. The following organic byproductswere considered: Methylchloride, Deschlor-C177(CGA 320114), CGA236317 and CGA110990. Furthermethods for the determination of water and free acids werepresented. Methylchloride, CGA 320114, CGA 236317, CGA110990.GC/FID (method AK1/2)LOQ = 0.1% methylchlorideLOQ=10 ppm CGA 110990For deschlor-C177 (CGA320114) and (CGA236317) novalidation could be preformed because no reference substanceswere available. The structures of these compounds and theirchromatographic behaviour are similar to dichlorvos. Thedetermination in samples was done using dichlorvos as externalstandard.WaterMethod: Karl FisherLOQ=>50, 100 ppmFree acidsFree acids were determined by the alcalimetric method. Apotentiometric titration of free acids was performed in awater/acetone mixture. The calculation was a sulphuric acid.Method AK 1/2 is not fully validated.TMP, ChloralAnalytical methods for residuesCalorimetric method (Denka analytical method no 107) notacceptableCVDC Chloral trichlorfonLC(reverse-phase)/UV (Denka analytical method no 109) notvalidatedWater (small quantities)Coloumetric (Denka analytical method no 110) LOQ= up to 1ppm, not validatedChloral, TMP,DMP,DMMP,TMPO,CVDPGLC/TCD (denka analytical method no 111) not validatedEU,2005EU,2005Soil (principle of Dichlorvos EU,2005Dichlorvos reassessment – application Page 118 of 436

method and LOQ)Water (principle ofmethod and LOQ)Matrix: soil and ryegrassGC/AFID (cross reference KIIA 4.2.2/01)Not validatedTrichlorfonMatrix: soil and turfgrassGC/EC/NPD (cross reference:KII4.2.2/02)Soil LOQ=0.02 ppm (EC), 0.09 ppm (NPD)Turfgrass LOQ=0.04 (EC), 0.2 ppm (NPD)If used for monitoring purpose needs an independent laboratoryvalidation that should be performed to GLP standard.DichlorvosMatrix: loch waterGC/ECD (cross reference KIIA 4.2.3/01)LOQ= 0.001 mg/LNot fully validatedEU,2005Matrix: waterHPLC/UV-Vis (cross reference KIIA 4.2.3/02)Not fully validatedMatrix: waterSPE (solid phase extraction)GC/SIM/MS (cross reference KIIA4.2.3/03)LOQ= 1 ng/gNot acceptableMatrix:distilled waterGC/MS (cross reference KIIA4.2.3/04)LOQ= 30 ig/LNot acceptableMatrix: waterSPME GC/NPD-SPME GC/MS-EPA 507 GLC/NPD (crossreference KIIA 4.2.3/05)LOQ= 2.50 ig/L EPA 507-GLC/NPDLOQ= 1.50 ig/L SPME GC/NPDLOQ=0.08 ig/L SPME GC/MSNot validatedAir (principle ofmethod and LOQ)DichlorvosGC/FPD or GC/AFID (cross reference KIIA 4.2.4/01) NotvalidatedEU,2005GC/FPD (cross reference KIIA 4.2.4/02) Not acceptableDichlorvos reassessment – application Page 119 of 436

GC/FPD (cross reference KIIA 4.2.4/03)LOQ=0.0019 mg/m 3GC/FPD (cross reference KIIA 4.2.4/04) LOQ=0.10 ig/sampleNot acceptableGC/FPD (cross reference KIIA 4.2.4/05)Potassium nitrate method/drechsel methodNot fully validatedBody fluids andtissues (principle ofmethod and LOQ)DichlorvosMatrix:lean tissue fluidsGLC/FPD (cross reference KIIA4.2.5/01)LOQ= 0.10 ppmNot fully validatedMatrix: serum urine (body fluid)HPLC/UV Diode-array detector array (cross reference KIIA4.2.5/02)LOQ= 6.8 mg/L (230 nm)Not fully validatedEU,2005Dichlorvos reassessment – application Page 120 of 436

Appendix B: Environmental Fate of dichlorvosTable B.1:Terrestrial fate and behaviour of dichlorvosDegradation in soilSummary InformationSoil photolysis Sandy loam soil, pH7 DT 50 15.5 days (same soil in dark, DT 50 , 16.5days)Aerobic, laboratorystudiesDT 50 lab (sandy loam, pH 5.7, slightly humic sand pH6.1),

Degradates, 2,2-dichloroacetic acid (26.6%) and 2,2-dichloroethanol(4.4%).From concrete and glass surfaces: DT 50

Bioconcentration factor Gnathopogon caerulescens (willow shiner), BCF≤1.2 APVMA, 2008Table B.3:Fate and behaviour in air of dichlorvosDirect photolysisin airSummary InformationReferenceNot expected from UV spectrum.APVMA, 2008DT 50

Appendix C: Environmental Exposure modellingAs ERMA New Zealand is unaware of locally monitored exposure concentrations, its riskassessment is based on modelling estimated environmental concentrations.Concentrations in surface waterERMA New Zealand has used the Generic Estimated Environmental Concentration Model v2(GENEEC2) surface water exposure model (USEPA 2001) to estimate the expectedenvironmental concentration (EEC) of dichlorvos in surface water which may potentially ariseas a result of spray drift and surface runoff, following wide dispersive use.The parameters used in the GENEEC2 modelling are listed in Table C.1.Table C.1:Input parameters for GENEEC2 analysisApplication rateApplication frequencyApplication intervalSee Table C2DichlorvosK d 0.41 USEPA, 1997Aerobic soil DT 50 1 day EU, 2005Pesticide wetted in?Methods of application‗No spray‘ zonenoSee Table C2noWater solubility 15 000 mg/l APVMA 2008Aerobic aquatic DT 50 1 day EU, 2005Aqueous photolysis DT 50 10.2 days USEPA, 2006ReferenceThe results of the modelling are summarised in Table C2 and the model output is shown inTable C3.Dichlorvos reassessment – application Page 124 of 436

Table C.2:Scenarios used in exposure modelling and aquatic estimated environmental concentrations for dichlorvosCrop Method rate scenario applications Estimated environmental concentration( µg/l)Equipment details Max gramai/ha/applicationNumberper yearInterval(days)peak 4 dayavg21 dayavg60 dayavgstrawberries boom Low,fine –mediumdropletVegetables,cereals, berriesFruit(tam./pers./berry)boomairblastHigh,fine –mediumdropletFinemediumdropletpassionfruit knapsack Finemediumdroplet800 1 1 - 9.7 6.0 1.5 0.5 0.32 2 7 9.8 6.1 1.5 0.5 0.4800 3 1 - 10.2 6.4 1.6 0.5 0.44 2 7 10.3 6.5 1.6 0.6 0.42052 5 1 - 27.1 17.2 4.2 1.5 1.06 2 7 27.5 17.5 4.3 1.5 1.01026 7 1 - 13.0 8.2 2.0 0.7 0.58 2 7 13.2 8.3 2.0 0.7 0.590 dayavgDichlorvos reassessment – application Page 125 of 436

Table C.3:Output from GENEEC2 exposure modellingScenario 1: Strawberry- 1 applicationRUN No. 1 FOR dichlorvos ON strawberri * INPUT VALUES *---------------------------------------------------------------------------------------------------------RATE (lb/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORPONE(MULT) INTERVAL Kd (PPM ) (%DRIFT) ZONE(FT) (IN)---------------------------------------------------------------------------------------------------------.712( .712) 1 1 .415000.0 GRLOFI( 2.9) .0 .0FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)---------------------------------------------------------------------------------------------------------------------METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED(FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)---------------------------------------------------------------------------------------------------------------------1.00 2 N/A 10.20- 1264.80 1.00 1.00GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001-------------------------------------------------------------------------------------------------PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAYGEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC-------------------------------------------------------------------------------------------------9.69 6.04 1.47 .52 .34Scenario 2: Strawberry – 2 applicationsRUN No. 2 FOR dichlorvos ON strawberri * INPUT VALUES *---------------------------------------------------------------------------------------------------------RATE (lb/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORPONE(MULT) INTERVAL Kd (PPM ) (%DRIFT) ZONE(FT) (IN)---------------------------------------------------------------------------------------------------------.712( .718) 2 7 .415000.0 GRLOFI( 2.9) .0 .0FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)-------------------------------------------------------------------------------------------------------------------METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED(FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)--------------------------------------------------------------------------------------------------------------------1.00 2 N/A 10.20- 1264.80 1.00 1.00GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001---------------------------------------------------------------------------------------------------PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAYGEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC---------------------------------------------------------------------------------------------------9.79 6.10 1.49 .52 .35Dichlorvos reassessment – application Page 126 of 436

Scenario 3: Vegetables – 1 applicationRUN No. 3 FOR dichlorvos ON vegetables * INPUT VALUES *--------------------------------------------------------------------------------------------------------RATE (lb/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORPONE(MULT) INTERVAL Kd (PPM ) (%DRIFT) ZONE(FT) (IN)--------------------------------------------------------------------------------------------------------.712( .712) 1 1 .415000.0 GRHIFI( 6.6) .0 .0FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)--------------------------------------------------------------------------------------------------------------------METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED(FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)--------------------------------------------------------------------------------------------------------------------1.00 2 N/A 10.20- 1264.80 1.00 1.00GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001---------------------------------------------------------------------------------------------------PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAYGEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC---------------------------------------------------------------------------------------------------10.16 6.41 1.56 .55 .37Scenario 4: Vegetables – 2 applicationsRUN No. 4 FOR dichlorvos ON vegetables * INPUT VALUES *----------------------------------------------------------------------------------------------------------RATE (lb/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORPONE(MULT) INTERVAL Kd (PPM ) (%DRIFT) ZONE(FT) (IN)----------------------------------------------------------------------------------------------------------.712( .718) 2 7 .415000.0 GRHIFI( 6.6) .0 .0FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)-------------------------------------------------------------------------------------------------------------------METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED(FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)-------------------------------------------------------------------------------------------------------------------1.00 2 N/A 10.20- 1264.80 1.00 1.00GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001--------------------------------------------------------------------------------------------------PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAYGEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC--------------------------------------------------------------------------------------------------10.29 6.50 1.59 .56 .37Scenario 5: Fruit- 1 applicationRUN No. 5 FOR dichlorvos ON fruit * INPUT VALUES *Dichlorvos reassessment – application Page 127 of 436

-----------------------------------------------------------------------------------------------------------RATE (lb/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORPONE(MULT) INTERVAL Kd (PPM ) (%DRIFT) ZONE(FT) (IN)----------------------------------------------------------------------------------------------------------1.827( 1.827) 1 1 .415000.0 ORCHAR( 9.7) .0 .0FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)--------------------------------------------------------------------------------------------------------------------METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED(FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)--------------------------------------------------------------------------------------------------------------------1.00 2 N/A 10.20- 1264.80 1.00 1.00GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001--------------------------------------------------------------------------------------------------PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAYGEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC-------------------------------------------------------------------------------------------------27.07 17.23 4.21 1.47 .98Scenario 6: Fruit- 2 applicationsRUN No. 6 FOR dichlorvos ON fruit * INPUT VALUES *--------------------------------------------------------------------------------------------------------RATE (lbAC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORPONE(MULT) INTERVAL Kd (PPM ) (%DRIFT) ZONE(FT) (IN)-------------------------------------------------------------------------------------------------------1.827( 1.841) 2 7 .415000.0 ORCHAR( 9.7) .0 .0FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)---------------------------------------------------------------------------------------------------------------------METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED(FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)--------------------------------------------------------------------------------------------------------------------1.00 2 N/A 10.20- 1264.80 1.00 1.00GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001---------------------------------------------------------------------------------------------------PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAYGEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC---------------------------------------------------------------------------------------------------27.47 17.52 4.28 1.50 1.00Scenario 7: Passionfruit- 1 applicationRUN No. 7 FOR dichlorvos ON passionfru * INPUT VALUES *-------------------------------------------------------------------------------------------------------RATE (lb/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORPONE(MULT) INTERVAL Kd (PPM ) (%DRIFT) ZONE(FT) (IN)-------------------------------------------------------------------------------------------------------.913( .913) 1 1 .415000.0 GRHIFI( 6.6) .0 .0Dichlorvos reassessment – application Page 128 of 436

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)--------------------------------------------------------------------------------------------------------------------METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED(FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)--------------------------------------------------------------------------------------------------------------------1.00 2 N/A 10.20- 1264.80 1.00 1.00GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001------------------------------------------------------------------------------------------------------PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAYGEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC------------------------------------------------------------------------------------------------------13.03 8.22 2.01 .70 .47Scenario 8: Passionfruit- 2 applicationsRUN No. 8 FOR dichlorvos ON passionfru * INPUT VALUES *----------------------------------------------------------------------------------------------------------RATE (lb/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORPONE(MULT) INTERVAL Kd (PPM ) (%DRIFT) ZONE(FT) (IN)----------------------------------------------------------------------------------------------------------.913( .921) 2 7 .415000.0 GRHIFI( 6.6) .0 .0FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)-----------------------------------------------------------------------------------------------------------------------METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED(FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)----------------------------------------------------------------------------------------------------------------------1.00 2 N/A 10.20- 1264.80 1.00 1.00GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001------------------------------------------------------------------------------------------------------PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAYGEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC-----------------------------------------------------------------------------------------------------13.20 8.34 2.04 .71 .48To examine how buffer zones would reduce the dichlorvos concentration in aquatic receivingwaters, ERMA New Zealand used the AgDrift model. The model was set to estimate thedichlorvos concentration in a 30 cm deep pond. The model indicated that at 304 m from theapplication area, the limit of the model, drift from a low boom, fine droplet size would beapproximately 0.1% of the field application rate.Concentrations in groundwaterThe concentration in groundwater has been estimated using the USEPA SCIGROW model.For one application the concentration ranges from 0.00069 to 0.00178 µg/L. For twoapplications the concentration ranges from 0.00138 to 0.00357 µg/L.Dichlorvos reassessment – application Page 129 of 436

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

3 Cereals3 Cereals(BBCH 30-39)(BBCH ≥40)4 Cereals(BBCH 10-19)4 Cereals (BBCH20-29)4 Cereals4 Cereals(BBCH 30-39)(BBCH ≥40)3 Leafyvegetables(BBCH 10-49)3 Leafyvegetables(BBCH ≥50)3 Leafy + fruitingvegetables andpulses(BBCH 10-19)3 Leafy + fruitingvegetables andpulses(BBCH 20-49)3 Leafy + fruitingvegetables andpulses(BBCH ≥50)3 Leafyvegetables andpulses(BBCH 10-19)3 Leafy + fruitingvegetables andpulses(BBCH 10-19)3 Leafy + fruitingvegetables andpulses(BBCH ≥20)4 Leafyvegetables(BBCH 10-49)birdSmallomnivorousbirdSmallomnivorousbirdSmallomnivorousbirdSmallomnivorousbirdSmallomnivorousbirdSmallomnivorousbirdSmallgranivorousbirdSmallgranivorousbirdSmallomnivorousbirdSmallomnivorousbirdSmallomnivorousbirdmediumherbivorous/granivorousbirdSmallinsectivorousbirdSmallinsectivorousbirdSmallgranivorousbird12.7 0.8 1 10.168.6 0.8 1 6.8824 0.8 1.4 26.8822.9 0.8 1.4 18.3212.7 0.8 1.4 14.228.6 0.8 1.4 9.6327.3 0.8 1 21.848.2 0.8 1 6.5624 0.8 1 19.222.9 0.8 1 18.328.6 0.8 1 6.8890.6 0.8 1 72.4826.8 0.8 1 21.4425.2 0.8 1 20.1627.3 0.8 1.4 30.58Dichlorvos reassessment – application Page 132 of 436

4 Leafyvegetables(BBCH ≥50)4 Leafy + fruitingvegetables andpulses(BBCH 10-19)4 Leafy + fruitingvegetables andpulses(BBCH 20-49)4 Leafy + fruitingvegetables andpulses(BBCH ≥50)4 Leafyvegetables andpulses(BBCH 10-19)4 Leafy + fruitingvegetables andpulses(BBCH 10-19)4 Leafy + fruitingvegetables andpulses(BBCH ≥20)3 Fruitingvegetable andpulses(BBCH 10-49)3 Fruitingvegetables andpulses(BBCH ≥50)4 Fruitingvegetables andpulses(BBCH 10-49)4 Fruitingvegetables andpulses(BBCH ≥50)3 Fruitingvegetables(BBCH 71-89)4 Fruitingvegetables(BBCH 71-89)4 FruitingvegetablesSmallgranivorousbirdSmallomnivorousbirdSmallomnivorousbirdSmallomnivorousbirdmediumherbivorous/granivorousbirdSmallinsectivorousbirdSmallinsectivorousbirdSmallgranivorousbirdSmallgranivorousbirdSmallgranivorousbirdSmallgranivorousbird8.2 0.8 1.4 9.1824 0.8 1.4 26.8822.9 0.8 1.4 25.658.6 0.8 1.4 9.6390.6 0.8 1.4 101.4726.8 0.8 1.4 30.0225.2 0.8 1.4 28.2224.7 0.8 1 27.667.4 0.8 1 5.9224.7 0.8 1.4 27.667.4 0.8 1.4 8.29frugivorous bird 49.4 0.8 1 39.52frugivorous bird 57.4 0.8 1.4 64.29frugivorous bird 49.4 0.8 1.4 55.33Dichlorvos reassessment – application Page 133 of 436

(BBCH 71-89)3 Bush &canefruit(BBCH 00-79)4 Bush &canefruit(BBCH 00-79)5 Orchard(spring/summer)5 Orchard(BBCH 10-19)5 Orchard(BBCH 20-39)5 Orchard(BBCH ≥40)5 Orchard(BBCH 10-19)5 Orchard(BBCH 20-39)5 Orchard(BBCH ≥40)6 Orchard(spring/summer)6 Orchard(BBCH 10-19)6 Orchard(BBCH 20-39)6 Orchard(BBCH ≥40)6 Orchard(BBCH 10-19)6 Orchard(BBCH 20-39)6 Orchard(BBCH ≥40)7 passionfruit(spring/SmallinsectivorousbirdSmallinsectivorousbirdSmallinsectivorousbirdSmallinsectivorousbirdSmallinsectivorousbirdSmallinsectivorousbirdSmallgranivorousbirdSmallgranivorousbirdSmallgranivorousbirdSmallinsectivorousbirdSmallinsectivorousbirdSmallinsectivorousbirdSmallinsectivorousbirdSmallgranivorousbirdSmallgranivorousbirdSmallgranivorousbirdSmallinsectivorousbird52.2 0.8 1 41.7952.2 0.8 1.4 58.4646.8 2.052 1 96.035.9 2.052 1 12.114.4 2.052 1 9.032.2 2.052 1 4.5121.9 2.052 1 44.9416.4 2.052 1 33.658.2 2.052 1 16.8346.8 2.052 1.4 134.455.9 2.052 1.4 16.954.4 2.052 1.4 12.642.2 2.052 1.4 6.3221.9 2.052 1.4 62.9116.4 2.052 1.4 47.118.2 2.052 1.4 23.5646.8 1.026 1 48.02Dichlorvos reassessment – application Page 134 of 436

summer)7 passionfruit(BBCH 10-19)7 passionfruit(BBCH 20-39)7 passionfruit(BBCH ≥40)7 passionfruit(BBCH 10-19)7 passionfruit(BBCH 20-39)7 passionfruit(BBCH ≥40)8 passionfruit(spring/summer)8 passionfruit(BBCH 10-19)8 passionfruit(BBCH 20-39)8 passionfruit(BBCH ≥40)8 passionfruit(BBCH 10-19)8 passionfruit(BBCH 20-39)8 passionfruit(BBCH ≥40)SmallinsectivorousbirdSmallinsectivorousbirdSmallinsectivorousbirdSmallgranivorousbirdSmallgranivorousbirdSmallgranivorousbirdSmallinsectivorousbirdSmallinsectivorousbirdSmallinsectivorousbirdSmallinsectivorousbirdSmallgranivorousbirdSmallgranivorousbirdSmallgranivorousbird5.9 1.026 1 6.054.4 1.026 1 4.512.2 1.026 1 2.2621.9 1.026 1 22.4716.4 1.026 1 16.838.2 1.026 1 8.4146.8 1.026 1.4 67.225.9 1.026 1.4 8.474.4 1.026 1.4 6.322.2 1.026 1.4 3.1621.9 1.026 1.4 31.4616.4 1.026 1.4 23.568.2 1.026 1.4 11.78Additional 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 dosePlants, off-target foliar exposureNo foliar exposure plant toxicity data were available to ERMA New Zealand, therefore noexposure assessment was made.Dichlorvos reassessment – application Page 135 of 436

Plants and soil organisms, off-target soil exposureMaximum application rates (Table C2) were used to calculate concentrations in soil adjacentto the application area. For off-field deposition of the substances it was assumed that driftfrom a 1 ha treated area was evenly distributed over a 1 ha non-target area. It was assumedthat 9.7% of the active ingredient will drift outside the target area by airblast application,6.6% by ground application high boom (vegetables, cereals, berries, maize), and 2.9% byground boom application low boom (strawberries, pasture). These drift assumptions werebased on GENEEC2 modelling. Dichlorvos application to passionfruit is by knapsack sprayer,but GENEEC2 does not provide a drift assumption for knapsack application. As passionfruitis a vigorous, climbing vine that clings by tendrils to almost any support it was assumed thatthe drift is comparable with a ground application high boom (6.6%). Results are shown inTable C6 for dichlorvos.Table C6:Deposition dichlorvos off-fieldApplication scenarioApplication rate(kg ai/ha)% of applicationdriftingDeposition bydrift (kg/ha)Deposition(mg/m 2 )Airblast 2.052 9.7 0.199 19.9Ground (high boom) 0.8 6.6 0.053 5.3Ground (low boom) 0.8 2.9 0.023 2.3Knapsack 1.026 6.6 0.068 6.8Soil concentrations of the active ingredient are calculated by assuming the deposition wouldmix into the top 5 cm of soil, and this soil would have a bulk density of 1500 kg/m 3 , ie thedeposition expressed in mg/m 2 would mix into 75 kg of soil.Deposition after 2 applications was calculated according to European guidance (EU, 2000):PEC multiple applications = PEC one application x (1- e -nki ) / (1-e –ki )Where for dichlorvosPEC = predicted environmental concentrationn = number of applications =2k= ln 2/ DT 50 (in days)i= interval between two consecutive applications in days= 7 daysDT 50 = half life soil in days = 1 daye = constant= 2.718The estimated soil concentrations of dichlorvos are shown in Table C8.Table C8:Soil concentration of dichlorvosApplicationscenarioSoil concentration off field (mg/kg)Soil concentration in field (mg/kg)1 application 2 applications 1 application 2 applicationsAirblast 0.27 0.27 2.74 2.74Ground (highboom)0.07 0.07 1.07 1.07Dichlorvos reassessment – application Page 136 of 436

Ground (lowboom)0.03 0.03 1.07 1.07Knapsack 0.09 0.09 1.37 1.37Terrestrial invertebratesERMA New Zealand has used the Guidance from ESCORT Workshop 2 to estimate the infieldand off-field exposure (Barrett et al 2000).In-field exposure is estimated using the formula:In-field exposure = application rate x MAFWhere:application rate is in g/haMAF is a multiple application factor listed in the guidance document. Inaccordance with the guidance the MAF is not applied for bees, only for othernon-target invertebrates.The estimated in-field concentrations are shown in Table C9 for dichlorvosTable C9:Terrestrial invertebrates- in-field exposure dichlorvosCropApplication rate(g ai/ ha)ApplicationfrequencyMAF 1In-field exposure(g ai/ha)strawberries 800 1 1 800800 2 1.7 1360Vegetables, cereals,berries800 1 1 800800 2 1.7 1360Fruit (tree) 2052 1 1 20522052 2 1.7 3488passionfruit 1026 1 1 10261026 2 1.7 17441: MAF= multiple application factor. In the absence of field data, default values are used. For 2 applications the default is1.7For the off-field exposure ERMA New Zealand used the formula:Off field exposure = application rate x MAF x (drift factor/ vegetation distribution factor)Whereapplication rate is in g/ha or ml/haMAF is a multiple application factorThe drift factors used in the model differ from the drift factors in GENEEC2modelling. The values used were recommended for use with this model(Rautmann et al, 2001).Dichlorvos reassessment – application Page 137 of 436

The vegetation distribution factor estimates the interception of drift byvegetation. For a generic assessment a value of 1 was used corresponding tothe worst case assessment of no interception.The estimated off field concentrations are shown in Table C10 for dichlorvos.Table C10:Terrestrial invertebrates- off field exposure dichlorvosCropApplicationrate(g ai/ ha)ApplicationfrequencyMAF 1Drift factor(= % drift/100)VegetationdistributionfactorOff fieldexposure(g ai/ha)Strawberries,Vegetables,cereals, berries800 1 1 0.0277 1 22.16800 2 1.7 0.0238 1 32.37Fruit (tree) 2052 1 1 0.2920(earlyseason)0.1573 (laterin season)2052 2 1.7 0.2553(earlyseason)0.1213 (laterin season)passionfruit 1026 1 1 0.2920(earlyseason)0.1573 (laterin season)1026 2 1.7 0.2553(earlyseason)0.1213 (laterin season)1 599.18322.781 890.59423.141 299.59161.391 445.29211.571: MAF= multiple application factor. In the absence of field data, default values are used. For 2 applications the default is1.7.Dichlorvos reassessment – application Page 138 of 436

Appendix D: Ecotoxicity of dichlorvosNo evaluation of chronic toxicity has been made due to the rapid dissipation of dichlorvos inthe environment.Table D.1:Aquatic toxicityAcute toxicityfishAcute toxicityinvertebrateSpecies and lifestage testedrainbow trout(Oncorhynchusmykiss)Rainbow trout(Oncorhynchusmykiss)Lake trout(Salvelinusnamacycush)Bluegillsunfish(Lepomismacrochirus)Bluegillsunfish(Lepomismacrochirus)Sheepsheadminnow(Cyprinodonvariegates)Sheepsheadminnow(Cyprinodonvariegates)Waterflea(Daphniapulex)Waterflea(Simocephalusserrulatus)Waterflea(Simocephalusserrulatus)Waterflea(Daphniamagna)Waterflea(Daphniamagna)Test substanceandconcentrationstestedTestmethodObservations andresults100 % ai 24 h LC 50 = 0.5 mg/L(supplemental)42 % ai 96 h LC 50 = 0.32 mg/L(supplemental)100% ai 96 h LC 50 = 0.183-0.187mg/L(supplemental)ReferenceUS EPA2006US EPA2006US EPA200698% ai 96 h LC 50 = 0.869 mg/L US EPA200642% ai 96 h LC 50 =1.86 mg/L(supplemental)US EPA200698% ai 96 h LC 50 =7.35 mg/L US EPA200642.39% ai 96 h LC 50 =6.146 mg/L US EPA2006100% ai 48 h EC 50 = 0.00007mg/L100% ai 48 h EC 50 = 0.00028mg/L(supplemental)100% ai 48 h EC 50 = 0.00026mg/L(supplemental)97/98% ai 48 h EC 50 = 0.00019mg/L99% ai 48 h LC 50 = 0.000085mg/LUS EPA2006EU 2003US EPA2006EU 2003US EPA2006EU 2005EU 2005Dichlorvos reassessment – application Page 139 of 436

eastern oyster(Crassostreavirginica)Mysid(Americamysisbahia)Mysid(Americamysisbahia)Anadaragranosa98% ai 96h EC 50 = 89.1 mg/L US EPA200698% ai 96 h EC 50 = 0.0191mg/L42% ai 96 h EC 50 = 0.0187mg/LUS EPA2006US EPA200691.17% ai 48 h LC 50 = 4.72 mg/L EU 2005Gammaruslacustris100% ai 96 h LC 50 = 0.0005mg/LEU 2005Toxicity toalgaegreen algae - 48 h EC 50 > 100 mg/L(supplemental)US EPA2006Unknownalgae- 48 h EC 50 = 14 mg/L(supplemental)US EPA2006Marine diatom - 48 h EC 50 = 17- 28mg/LSelenastrumcapricornutum(supplemental)US EPA200697-98% ai 94 h E r C 50 = 140 mg/L EU 2005Scenedesmussubspicatus98.1% ai 96 h E r C 50 = 160 mg/L EU 2005Scenedesmussubspicatus- 96 h EC 50 =52.8 mg/LbiomassproductionAPVMA2008Toxicity toaquatic vascularplantsNDAcute toxicitysedimentdwellingorganismsChironomusriparius(larvae)94% ai 24 h EC 50 = 0.00873mg/L withoutsedimentEC 50 = 0.0167mg/L withsedimentEU 2005ActivatedsludgeNDTable D.2:BioconcentrationSummary InformationBioconcentrationBioconcentration factor (BCF) Log Kow = 1.47This indicates a low potential forReferencePMRA,2008Dichlorvos reassessment – application Page 140 of 436

ioaccumulationClearance timeLevel of residues (%) in organisms after the 14day depuration phaseNDNDTable D.3:Acute oraltoxicity tomammalsAcute oraltoxicity to birdsTerrestrial vertebrate toxicitySpecies andlife stagetestedTest substance anddoses/concentrationstestedTestmethodObservations andresultsrat - LD 50 = 46.4mg/kgPheasant 93 % ai - LD 50 = 11.3mg/kgReferenceAPVMA,2008US EPA2006Bobwhitequail96.5% - LD 50 = 8.8 mg/kg US EPA2006Mallardduck93% - LD 50 = 7.78mg/kgUS EPA2006Dietary toxicityto birdsJapanesequailPekingduck14 d LD 50 = 6.6 mg/kg(not acceptable)7 d LD 50 = 10.8mg/kg(not acceptable)chicken 21 d LD 50 = 10.18mg/kgCommonpigeonChicken(whiteleghorn)(not acceptable)21 d LD 50 = 3.28mg/kg(not acceptable)24 h LD 50 = 6.45mg/kg(not acceptable)pheasant 94.8% 5 day LC 50 =568 mgai/kgEU 2005EU 2005EU 2005EU 2005EU 2005US EPA2006Mallardduck94.8% 5 day LC 50 =1317 mgai/kgUS EPA2006Mallardduck94.8% 5 day LC 50 >5000 mgai/kgUS EPA2006Dichlorvos reassessment – application Page 141 of 436

JapanesequailJapanesequailJapanesequailChicken(whiteleghorn)8 d LC 50 >75 mg/kgfood(not acceptable)8 d LC 50 >10 mg/kgfood(formulation)(not acceptable)8 d LC 50 = 251mg/kg feed28 d LC 50 = 500mg/kg food(not acceptable)EU 2005EU 2005EU 2005EU 2005Table D.4:Toxicity to other soil dwelling organismsEffects on earthwormAcute toxicityField or semifieldtestsSpecies andlife stagetestedEiseniafetidaEiseniafetidaNDEffects on soil micro-organismsNitrogen mineralizationCarbon mineralisationActivated sludgeTerrestrial plantsSeedling emergenceVegetative vigourTest substance anddoses/concentrationstested0, 10, 18, 32, 56and 100 mg ai/kgsoilTestmethodObservations andresults14 d LC 50 = 14 mgai/kgNOEC = 10 mgai/kg- 14 d LC 50 = 80.9 mgai/kgTest substance anddoses/concentrations testedDichlorvos0, 1.5 and 13.4 mg ai/kg in loamand sand soil, 28 dDichlorvos0, 1.28 and 13.4 mg ai/kg in loamand humic sand soil, 28 dDichlorvos100 mg ai/L, 30 minNDNDNOEC < 12.3 mgai/kgObservationsand resultsNo effect on soilnitrification atconcentrations upto 13.4 mg ai/kg.No effect on soilmicrobial biomass(measured as soilrespiration) atconcentrations upto 13.4 mg ai/kg.EC 50 = 100 mgai/LReferenceEU 2005APVMA2008ReferenceEU 2005EU 2005EU 2005Dichlorvos reassessment – application Page 142 of 436

Table D.5:Toxicity to terrestrial invertebratesSpeciesand lifestagetestedEffects on honeybeesAcute oraltoxicityHoneybeeTest substance anddoses/concentrationstestedTestmethodObservationsand resultsdichlorvos - LD 50 = 0.029µg/ beeReferenceEU 2005AcutecontacttoxicityHoneybeedichlorvos - LD 50 = 0.495µg/ beedichlorvos - LD 50 = 0.065µg/ beeUS EPA 2006EU 2005Dichlorvos 100 EC 72 h LD 50 < 0.41 µg/beeEU 2005dichlorvos 24 h LD 50 = 0.6 µg/bee (estimation)EU 2005Field or semi-field testshoneybeedichlorvos LD 50 = 0.052-0.9 µg/ beeDichlorvos residueon foliageLD 50 = 0.2 kgai/ haAPVMA 2008APVMA 2008Effects on other arthropod speciesLaboratory testsPredatory mite(Phytoseiuluspersimilis)Ladybird(Curinuscoeruleus)Speciesand lifestageAdult,eggsadultTest substance anddoses/concentrationstestedDichlorvos 100 atdose rate of 100 g ai/100 LDichlorvos 0.08 kgai/haTestmethodExtendedlab test,roseleafletsLab test, 72hObservationsand resultsDichlorvos hadadverse effects onthe developmentof the adults, noton that of larvae.ReferenceEU 200560% mortality EU 2005Dichlorvos reassessment – application Page 143 of 436

Environmental classificationOn the basis of these ecotoxicity data, dichlorvos was classified for environmental endpointsas follows:Table D.6:Environmental classification of dichlorvosHazard Class/SubclassHazardclassificationMethod of classificationReferenceSubclass 9.1 9.1A Fish: bluegill sunfish LC 50 = 0.869mg/LCrustacean: Daphnia pulex EC 50 =0.00007 mg/LAlgae: Selenastrum capricornutumE r C 50 = 140 mg/LUS EPA 2006US EPA 2006EU 2005Subclass 9.2 9.2B Earthworm: LC 50 = 14 mg/kgEU 2005( EC 50 = 1.4 mg/kg)Subclass 9.3 9.3A ratLD 50 = 46.4 mg/kgBird: mallard duckAPVMA, 2008US EPA 2006LD 50 = 7.78 mg/kgSubclass 9.4 9.4A HoneybeeEU 2005LD 50 oral = 0.029 µg/beeLD 50 contact = 0.065 µg/beeDichlorvos reassessment – application Page 144 of 436

Appendix E: Risk Assessment: Environment dichlorvosIntroductionAn estimation of environmental risks has been made on the basis of available information onthe use of dichlorvos using standard modelling tools to estimate exposure concentrations incombination with the data on the ecotoxicity of the substance.For Class 9 substances, irrespective of the intrinsic hazard classification, the ecological riskcan be assessed for a substance or its components by calculating a risk quotient (RQ) based onmeasured or estimated exposure concentrations. Estimated exposure concentrations (EEC)are calculated taking into account use scenarios (including spray drift, application rates andfrequencies), and the fate of the product including half-lives of the component(s) in soil andwater. Dividing an EEC by the LC 50 or EC 50 generates an acute RQ whilst dividing the EECby the NOEC generates a chronic RQ as follows:Acute RQ = EEC Chronic RQ = EECLC 50 or EC 50NOECIf the RQ exceeds a predefined level of concern (see below), it may be appropriate to refinethe risk assessment or apply controls to ensure that appropriate matters are taken into accountto minimise off-site movement of the substance. Conversely, if a worst-case scenario is used,and the level of concern is not exceeded, then in terms of the environment, there is apresumption of low risk which is able to be adequately managed by existing controls.For the assessment of environmental effects of dichlorvos, no evaluation of chronicenvironmental risk has been made due to its rapid dissipation in the field.Levels of concern (LOC) developed by the USEPA (Urban & Cook, 1986), and adopted byERMA New Zealand, to determine whether a substance poses an environmental risk areshown in Table E.1.Table E.1:Levels of concern in environmental risk assessment for aquatic andterrestrial organismsAquatic (fish, invertebrates)Level of Concern(LOC)PresumptionAcute RQ ≥0.5 High acute riskPlants (aquatic and terrestrial)0.1–0.5 Risk can be mitigated through restricted use

TER= LD 50 / estimated environmental concentrationHQ bees = application rate/ LD 50HQ invertebrates = exposure/ LR 50Table E.2:Levels of concern in environmental risk assessment for terrestrial organismsBird/ earthwormLevel of Concern(LOC)PresumptionAcute TER 50Terrestrial invertebratesHQ < 2 Low riskHQ Higher tier < testing required≥2Aquatic organismsAcute risks to aquatic organisms are shown in Table E.3.Dichlorvos reassessment – application Page 146 of 436

Aquatic organsimsTable E.3:Environmental risk quotients for aquatic organsimsCompartmentExposuredurationExpected Environmental concentration (µg/L)(for Scenarios 1-8*)ReceptorEffectconcentra-tion(µg/L)Risk Quotient(for Scenarios 1-8*)1 2 3 4 5 6 7 8 1 2 3 4 5 6 7 8Freshwater Acute 9.7 9.8 10.2 10.3 27.1 27.5 13.0 13.2 Fish 870 0.011 0.011 0.012 0.012 0.031 0.032 0.015 0.015Invertebrates 0.07 139 140 146 147 387 393 186 189Plants 140000 0.00007 0.00007 0.00007 0.00007 0.00019 0.0002 0.00009 0.00009*Scenarios1 Strawberries, 1 application2 Strawberries, 2 applications3 Vegetables, cereals,berries, 1 application4 Vegetables, cereals,berries, 2 applications5 Fruit, 1 application6 Fruit, 2 applications7 Passionfruit, 1 application8 Passionfruit, 2 applicationsDichlorvos reassessment – application Page 147 of 436

Comparison of levels of concern (Table E.1) to the risk quotient in Table E.3 showshigh acute risk to invertebrates in the freshwater environment. The risks to fish andaquatic plants are low. This conclusion is based on Tier 0 modelling of exposure(GENEEC2).To explore risk reduction options, ERMA New Zealand used the AgDrift model toestimate the buffer zone that would reduce exposure through spray drift to aconcentration unlikely to cause acute toxicity. The receiving water was defined as a 30cm deep pond. Spray drift is only one route of exposure by which dichlorvos willcontaminate the aquatic environment, but given the rapid dissipation of dichlorvos itwill be important. The model indicated that even for the lowest application rate (800 gai/ha), a buffer zone > 304 meters is required to reduce the receiving waterconcentration to less than the lowest acute EC/LC 50 .GroundwaterTier 0 modelling of concentrations in groundwater predicts concentrations from 0.00069to 0.0036µg/L. In the EU, 0.1 µg/L is the concentration above which the predictedconcentration is considered to be unacceptable. As this level of concern is not exceededERMA New Zealand considers the risks for groundwater are low.BirdsThe avian toxicity assessment was performed according to ―Risk Assessment to Birdsand Mammals (EFSA 2008)‖. The risk assessment is based on a TER (toxicity-exposureratio) approach. For pesticides in general, mortality is unlikely when TER ≥ 10 (acuterisk). No assessment of chronic risk was made due to the rapid dissipation ofdichlorvos in the environment.Table E.4:Acute avian risk assessment – screening stepScenario Crop 1 IndicatorSpecies 2 LD 503DDD 4 TER 5 valueTrigger1 strawberries Small omnivorous bird 9.18 127.04 0.07

12345Crop type Table I.1 (Annex 1) and Appendix 10Species type Table I.1 (Annex 1) and Appendix 10Geometric mean if multiple species testedDDD = daily dietary doseToxicity-exposure ratio = LD 50 / Estimated environmental concentrationFor all scenarios the toxicity:exposure ratio triggers higher tier risk assessment.Table E.5:Acute avian risk assessment- first tier assessmentScenario Crop 1 IndicatorSpecies 2 LD 5031 Strawberry(BBCH 10-19)1 Strawberry(BBCH 20-39)1 Strawberry(BBCH ≥40)1 Strawberry(BBCH 10-19)1 Strawberry(BBCH ≥20)3 Cereals(BBCH 10-19)3 Cereals (BBCH 20-29)3 Cereals3 Cereals(BBCH 30-39)(BBCH ≥40)3 Leafy vegetables(BBCH 10-49)3 Leafy vegetables(BBCH ≥50)3 Leafy + fruitingvegetables and pulses(BBCH 10-19)3 Leafy + fruitingvegetables and pulses(BBCH 20-49)3 Leafy + fruitingvegetables and pulses(BBCH ≥50)3 Leafy vegetables andpulsesDDD 4 TER 5 TriggervalueSmall omnivorous bird 9.18 19.2 0.48

(BBCH 10-19)3 Leafy + fruitingvegetables and pulses(BBCH 10-19)3 Leafy + fruitingvegetables and pulses(BBCH ≥20)3 Fruiting vegetableand pulses(BBCH 10-49)3 Fruiting vegetablesand pulses(BBCH ≥50)3 Fruiting vegetables(BBCH 71-89)3 Bush &cane fruit(BBCH 00-79)5 Orchard(spring/summer)5 Orchard(BBCH 10-19)5 Orchard(BBCH 20-39)5 Orchard(BBCH ≥40)5 Orchard(BBCH 10-19)5 Orchard(BBCH 20-39)5 Orchard(BBCH ≥40)7 passionfruit(spring/summer)7 passionfruit(BBCH 10-19)7 passionfruit(BBCH 20-39)7 passionfruit(BBCH ≥40)7 passionfruit(BBCH 10-19)Small insectivorousbirdSmall insectivorousbird9.18 21.44 0.43

7 passionfruit(BBCH 20-39)7 passionfruit(BBCH ≥40)Small granivorous bird 9.18 16.83 0.55

Table E.8:Earthworm –TER in-fieldApplicationscenarioEarthwormacute toxicity14 d LC 50(mg/kg)Soil concentration in-field(mg/kg) both 1 and 2applicationsTER in-fieldAirblast 14 2.74 5

Fruit (tree) 2052 70759 >50Passionfruit 1026 35379 >50These HQ greatly exceed the critical HQ of 50. HQ values that exceed levels ofconcern may be refined using the results of higher tier testing such as semi-field andfield trials. However, no data from higher tier testing were available to ERMA NewZealand.ERMA New Zealand notes that in APVMA (2008) the results of a foliar residue studyare provided. The LD 50 value was reported to be 0.2 kg ai/ha, which is less than NewZealand application rates, but no other information was available. By contrast, USEPA (2006) reports the results of a study on the toxicity of foliar residues to honey bees(guideline 141-2) using the typical end-use product. The study showed residues ofdichlorvos 4E applied at 0.5 lb ai/A (= 0.56 kg ai/ha) were practically nontoxic to honeybees three hours post treatment.Terrestrial invertebrates (other than bees)No data are available to perform a quantitative risk assessment. However, there are twostudies on non-target invertebrates. The results of those tests show that dichlorvos hadadverse effects on the development of adult predatory mites (Phytoseiulus persimilis)and that 0.08 kg dichlorvos per ha caused 60% mortality of the ladybirds (Cuinuscoeruleus). Based on this information and the mode of action of dichlorvos ERMA NewZealand expects dichlorvos to be toxic to a wide range of terrestrial non-targetinvertebrates coming in contact with the spray, vapours or fresh residue.Conclusions environmental risksERMA New Zealand concludes that the levels of concern are exceeded for aquaticorganisms, birds and terrestrial invertebrates. ERMA New Zealand also identified a riskfor earthworms in the field when dichlorvos is applied by airblast equipment. Highertier modelling could potentially refine these estimates of the risks but it is unlikely toreduce the risk quotients, particularly for the aquatic environment by the orders ofmagnitude required to remove the estimation of risks. Therefore risk mitigationmeasures need to be considered.Buffer zones can be used to mitigate risks to the aquatic environment. However, fordichlorvos a buffer zone of more than 304 meters, the maximum calculated by themodel, is needed to reduce the risk to an acceptable level. Buffer zones are notprotective of birds and terrestrial invertebrates that may move in and out of a crop.Timing of application to avoid times bees are foraging will reduce the risks to bees, butwould not reduce the risk to other non-target invertebrates that live within or adjacent tocrops.Dichlorvos reassessment – application Page 153 of 436

Restricting application rates or frequencies would be unlikely to reduce risks toacceptable levels due to the size of the risk quotients determined for even a singleapplication.Dichlorvos reassessment – application Page 154 of 436

Appendix F: Human Toxicity of dichlorvosDichlorvos (DDVP):Review of Toxicology and HSNO Classifications 6 and 8For:ERMA New Zealand20 Customhouse QuayPO Box 131WellingtonNEW ZEALANDPrepared by:Martin Edwards PhDToxicology Consulting Ltd36 Hastings ParadeDevonport 0624North Shore Cityedwardsm@ihug.co.nzVersion: 2.0 DraftJune 2009Dichlorvos reassessment – application Page 155 of 436

1 PURPOSE1.1 The purpose of this report is, for the Environmental Risk ManagementAuthority New Zealand (ERMA New Zealand) reassessment of dichlorvos(DDVP), to:review the toxicologyreview the HSNO Classifications 6 and 8propose AOEL(s)1.2 The key aspects to extract from the overseas regulatory reviews are:type of studyspecies/straintest materialdose levelsendpointremarks - findings (adverse effects)GLP/Test Guidelinereference (including date of original source)reliabilityjustificationwith any data gaps or endpoints with insufficient data clearly identified.1.3 The scope of the context used to form this assessment is confined to thedocuments listed in the Reference section of this document, the timeconstraints, the professional experience of the author, and the date thisdocument was issued.1.4 The assessment constitutes the whole document and the reference sources,and should only be used as a whole.1.5 In spite of all care taken, the reference material should be directlyconsulted to check the veracity of data, opinions and other material usedand attributed in this document.1.6 No responsibility will be taken for misuse of this document, or use bythird parties.Dichlorvos reassessment – application Page 156 of 436

CONTENTS:Title Page 11 Purpose 2Contents 32 Substance Identification 53 Toxicology Hazard Profile – Introduction 64 Absorption, Distribution, Metabolism and Elimination (ADME) 94.1 Absorption 94.2 Distribution 124.3 Metabolism 134.4 Elimination 145 Acute Oral 6.1 166 Acute Dermal 6.1 197 Acute Inhalation 6.1 218 Skin Irritation 6.3 & Corrosion 8.2 259 Eye Irritation 6.4 & Corrosion 8.3 2710 Respiratory Sensitisation 6.5A 2911 Contact Sensitisation 6.5B 3012 Mutagenicity 6.6 3313 Carcinogenicity 6.7 4114 Reproductive Toxicity 6.8 5615 Developmental Toxicity 6.8 6316 Reproductive or Developmental Effects on or via Lactation 6.8C 6917 Specific Target Organ Toxicity 6.9: Single dose – oral 7118 Specific Target Organ Toxicity 6.9: Single dose – dermal 75Dichlorvos reassessment – application Page 157 of 436

19 Specific Target Organ Toxicity 6.9: Single dose – inhalation 7720 Specific Target Organ Toxicity 6.9: Repeat dose – oral 7921 Specific Target Organ Toxicity 6.9: Repeat dose – dermal 8622 Specific Target Organ Toxicity 6.9: Repeat dose – inhalation 8723 Other Potential Toxic Endpoints 9123.1 Endocrine disruption 9123.2 Neurotoxicity 9223.3 Immunotoxicity 9724 Human Exposure Reports 9825 AOEL 10126 Summary & Conclusions 110References 115Appendix 1: Summary of benchmarks used in occupational risk assessments(APVMA, 2008b) 117Last Page 123Dichlorvos reassessment – application Page 158 of 436

2 SUBSTANCE IDENTIFICATIONIUPAC name:Chemical name (CAS):Common name:2,2-dichlorovinyl dimethylphosphate2,2-dichloroethenyl dimethylphosphate;Phosphoric acid, 2,2-dichloroethenyl dimethyl esterDichlorvos; DDVPCAS Registry number: 62-73-7Molecular formula: C 4 -H 7 -Cl 2 -O 4 -PMolecular weight: 220.97Structural formula:(ChemID; HSG 18, 1988)Vapour pressure: 0.0158 mm Hg = 2.1 Pa (CCID, 2009)Dichlorvos reassessment – application Page 159 of 436

3 TOXICOLOGICAL HAZARD PROFILE – INTRODUCTIONDichlorvos exerts its toxic effects by inhibiting neural acetylcholinesterase inhumans and animals. Throughout the central and peripheral nervous systemscholinergic synapses contain this enzyme, which is responsible for hydrolyzingacetylcholine released from the pre-synaptic terminal. Dichlorvos chemicallyreacts with the active site of acetylcholinesterase and inhibits enzyme activity.Inhibition of neural acetylcholinesterase allows acetylcholine to accumulate in thesynapse, resulting in increased firing of the postsynaptic neuron or increasedneuroeffector activity. Increased cholinergic activity in the parasympatheticautonomic nervous system (muscarinic receptors) can include increasedsalivation, lacrimation, perspiration, miosis, nausea, vomiting, diarrhea, excessivebronchial secretions, bradycardia, frequent micturition, and incontinence.Increased neuroeffector activity on skeletal muscles (nicotinic receptors) caninclude muscle fasciculations, cramps, muscle weakness, and depolarization-typeparalysis. Effects on central nervous system (predominantly muscarinic) includedrowsiness, fatigue, mental confusion, headache, convulsions, and coma. Theseclassical symptoms of organophosphate neurotoxicity increase in severity andrapidity of onset in a dose-dependent manner (Ecobichon 1991). (Originals notsighted in APVMA, 2008a)Erythrocytes also contain acetylcholinesterase, erythrocyte (or RBC)acetylcholinesterase. Both neural and erythrocyte acetylcholinesterase areproduced by the same gene (Taylor et al., 1993). Erythrocyte and neuralacetylcholinesterase in in vitro systems are inhibited to roughly the same extent byexposure to dichlorvos (Hayes 1982). Erythrocyte acetylcholinesterase is used as asurrogate measurement of the inhibition of neural acetylcholinesterase. The liverproduces a cholinesterase that circulates in the blood. This cholinesterase, calledserum (or plasma) cholinesterase, is also inhibited by dichlorvos and is anothermarker for exposure. Usually, this enzyme is inhibited by dichlorvos at lower levelsof exposure than required to inhibit neural or erythrocyte acetylcholinesterase(Hayes 1982). (Originals not sighted; ATSDR, 1997)Dichlorvos has high acute toxicity in experimental animals. Clinical signs of toxicityoccur soon after dosing and are typical of organophosphate poisoning (exophthalmus,salivation, lachrymation, tremors, dyspnoea, convulsions and death). Survivors recovercompletely within 24 hours (Durham et al., 1957; Lamb 1992). The time to peak effectin rats following oral dosing is 15-60 minutes (Tyl et al., 1990a; Lamb 1992; Lamb1993b). (Originals not sighted; APVMA, 2008a)There is an extensive genotoxicity database for dichlorvos. Negative results werereported in in vivo host-mediated, dominant lethal, sister chromatid exchange andmicronucleus assays (except on skin after local application at cytotoxic doses).Dichlorvos was reported not to induce in vivo chromosomal aberrations in bone-marrowcells, spermatocytes or spermatogonia (Dean & Thorpe, 1972a; Moutschen-Dahmen etal., 1981; Degraeve et al., 1984b), DNA strand breaks (Wooder & Creedy, 1979) orunscheduled DNA synthesis (Mirsalis et al., 1989; Bedford, 1991). (Originals notsighted; WHO, 1993)Dichlorvos reassessment – application Page 160 of 436

However, dichlorvos has genotoxic potential at localised high concentrations and in theabsence of metabolism, demonstrated by micronucleus formation in mouse epidermalkeratinocytes after direct application of dichlorvos to the skin; an increase in themutation frequency in the liver of transgenic mice following repeated intraperitonealinjection; and, an increased incidence of hair follicle nuclear aberrations (NA) in CD1mice after a single application at 1/8 th the dermal LD 50 (non-guideline method).Dichlorvos was mutagenic and DNA-reactive in bacteria and other microorganisms invitro, in both the presence and absence of exogenous metabolic activation (althougheffects were commonly reduced in the presence of exogenous metabolic activation).Dichlorvos was also mutagenic and clastogenic in a range of mammalian cells exposedin vitro, including induction of UDS but not chromosomal aberrations or SCE incultured human cells.Dichlorvos is an electrophile and stated to possess a structural alert formethylating activity. While dichlorvos possesses methylating activity, thephosphorous atom of the molecule is reported to be a stronger electrophile thanthe methyl carbon atoms (phosphorylating reactivity). In tissues and blood,dichlorvos is much more likely to react with “A”-type esterases, serumcholinesterase, or acetylcholinesterase than with DNA (ATSDR, 1997; APVMA,2008a).Therefore, dichlorvos is mutagenic and clastogenic at the point of contact, whereunchanged dichlorvos may be in direct contact with tissue [DDVP‘s inherent potential].There is no evidence that dichlorvos has any systemic genotoxic potential, due to thesubstance‘s inherent phosphorylating reactivity and the highly efficientbiotransformation [low risk].Dichlorvos revealed an increased incidence of adenomas of the exocrine pancreas inmale F344/N rats (2-year dietary study) indicated some evidence of carcinogenicactivity of dichlorvos, as did the increased incidences of forestomach squamous cellpapillomas in male and female B6C3F 1 mice (2-year dietary study). While forestomachtumours are not considered directly relevant to humans, these findings (and themutagenic potential in certain contact scenarios) indicate that repeated exposure to highconcentrations of dichlorvos poses some carcinogenic hazard.Dichlorvos revealed no evidence of particular reproductive or developmental toxicity,with adverse effects only noted at maternotoxic doses.The APVMA (2008a) summarised:―Dose-related inhibition of plasma, RBC and brain ChE activities was themost common manifestation of dichlorvos toxicity in short-term, subchronicand chronic studies in mice, rats and dogs. Cholinergic signs and occasionalmortalities occurred in rats and dogs at the same doses as the inhibition ofbrain ChE activity. Plasma and RBC ChE activities were also inhibitedfollowing chronic inhalational exposure in rats (LOEC = 0.5 mg/m 3 ; Blair etal., 1974 & 1976). There was little indication that repeated oral orinhalational exposure had any effect on haematology, clinical chemistry orDichlorvos reassessment – application Page 161 of 436

urinary parameters, or on organ weights or gross pathology. In some rat anddog studies, histopathology revealed cytoplasmic vacuolisation of the liver(Jolley et al., 1967; Witherup et al., 1967; Chan 1989).‖ (Originals notsighted; APVMA, 2008a)Dichlorvos reassessment – application Page 162 of 436

4 ABSORPTION, DISTRIBUTION, METABOLISM AND ELIMINATION (ADME)Dichlorvos is a relatively small, lipid-soluble molecule that can be absorbed bypassive diffusion through the lungs, gastrointestinal tract, or skin. Dichlorvosappears to be rapidly absorbed by the oral and dermal routes of exposure.Dichlorvos is difficult to assay in biological tissues, so this rapid rate of absorptionis inferred from the time to onset of clinical signs and/or cholinesterase inhibition.The rapid degradation of dichlorvos by tissue esterases, particularly in the liverand the serum contribute to the assay difficulties. The half-life of dichlorvos inhuman blood in vitro is about 10 minutes (Blair et al., 1975). Dichlorvos does notappear to have preferential distribution to particular tissues, to be stored orconcentrated in any tissue. Esterase-catalysed degradation of dichlorvos producesdimethyl phosphate and dichloroacetaldehyde. Dimethyl phosphate is excreted inthe urine, while dichloroacetaldehyde can be reduced to dichloroethanol ordehalogenated to glyoxal, which enters 2-carbon metabolism pool. Dichloroethanolis either conjugated to glucuronic acid and excreted in the urine or dehalogenatedand further metabolised. Dichlorvos can also be demethylated in a glutathionedependentreaction. (Originals not sighted; ATSDR, 1997)4.1 Absorption:OralCalDRP (1996) reported:―DDVP ( 14 C- and 32 P-labelled, 10 mg/kg [b.w.], 78 and 67-78% purity,respectively) was rapidly absorbed following gavage administration toalbino rats (strain not specified) (Casida et al., 1962).‖ (Originals notsighted; CalDPR, 1996)The ATSDR (1997) reported:“When 5 mg [vinyl- 14 C]dichlorvos was ingested in orange juice by amale volunteer, 27% of the dose was recovered from expired air as14 CO, (Hutson and Hoadley 1972b). Dichlorvos was detected (0.18mg/L) in the blood of fetuses 5 minutes after oral administration of 6mg/kg [b.w.] dichlorvos in sunflower oil to 5 pregnant rabbits on theday of delivery (Maslinska et al., 1979). A total of 38.2% of the [l- 14 C-vinyl]dichlorvos (40 mg/kg [b.w.] in PVC pellets) was absorbed in 9young male Yorkshire pigs (Potter et al., 1973a), the remainder wasrecovered in the pellets. In another experiment, where [l-14 Cvinylldichlorvos was mixed with feed, absorption of dichlorvos wasdemonstrated by the recovery of 4% of the radioactivity in the urine,5% in the feces, and 6.6% in the expired air (Potter et al., 1973b).“Small amounts (ppb) of organosoluble [ 32 P] (presumably dichlorvos ordesmethyl dichlorvos) was detected in the milk of a lactating cow afterthe oral administration of 1 mg/kg [b.w.]/day [ 32 P]dichlorvos for 7 daysfollowed by a dose of 20 mg/kg [b.w.] on day 8 in gelatin capsulesDichlorvos reassessment – application Page 163 of 436

(Casida et al., 1962). Dichlorvos was effectively absorbed in 6 male and6 female rats following the oral administration of 3.6 mg/kg [b.w.][methyl- 14 C]dichlorvos in arachis oil as indicated by the recovery of64.6% of the dose in urine (Hutson and Hoadley 1972a). Identicalrecovery was obtained in 6 male and 6 female mice given 22 mg/kg[b.w.] [methyl-14C]dichlorvos (Hutson and Hoadley 1972a). When[vinyl- 14 C]dichlorvos was administered orally to 2 male Syrianhamsters at a dose of 3.7 mg/kg [b.w.] and to a female at a dose of 1.5mg/kg [b.w.], it was rapidly absorbed and 11.9-21.8% of the dose wasrecovered in the urine.“Evidence for rapid absorption of dichlorvos by the oral route includesdeath of Swiss mice within 9 minutes after a single gavage dose of 150mg/kg [b.w.] (Mohammad et al. 1989) and in crossbred swine within15-30 minutes receiving 100-560 mg/kg [b.w.] in an LD50 study(Stanton et al., 1979). Signs of cholinergic toxicity (vomiting, diarrhea)were observed in greyhound dogs within 7-15 minutes of receiving 11mg/kg [b.w.] dichlorvos by gelatin capsule (Snow and Watson 1973).(Originals not sighted; ATSDR, 1997)InhalationCalDRP (1996) reported:―In a comparison study with the oral route of exposure, rats (male, strain notgiven) were exposed to DDVP (0.71-1.07 mg in vapor) for 1 hour by noseonlyinhalation (Hutson et al., 1971). Urine, feces, exhaled air, and tissueswere collected following the same protocol as the oral route. The actualadministered dose was unknown since DDVP adsorbed to the apparatus.Therefore, results were expressed as the percentage of the total recoveredyield of carbon dioxide, the major metabolite. The amount of radioactivityretained in the tissues was similar to those for the oral route with the highestradioactivity level in the liver. The rates and routes of excretion, and urinarymetabolites by the inhalation route were considered similar to those afteroral administration.‖ (Originals not sighted; CalDPR, 1996)The ATSDR (1997) reported:“Indirect evidence for absorption of dichlorvos following inhalation inhumans was obtained by measuring dichloroethanol, a specificdichlorvos metabolite, in the urine of a male volunteer (Hutson andHoadley 1972b). This individual was exposed at the extremely highlevel of 38 mg/m3 (4.2 ppm) for 105 minutes. The first urine sampleobtained after exposure ended was analyzed by gas-liquidchromatography and 0.42 μg dichloroethanol/mL urine was detected(Hutson and Hoadley 1972b). The dichlorvos metabolite dimethylphosphate was found in the urine of 3 of 13 male volunteer pesticideapplicators who applied dichlorvos during an 8-hour workday (Das etal., 1983). During the application, they wore goggles, caps, respirators,coats, gloves, and shoes. Each applicator sprayed 4 homes using 10-14Dichlorvos reassessment – application Page 164 of 436

aerosol cans (230-330 g dichlorvos) and 18-22 pints of 0.5% emulsionspray (40-50 g dichlorvos). A range of 0.32-l .39 μg of dimethylphosphate was measured in the urine of 3 workers. No effect was seenin clinical parameters or plasma cholinesterase activities. Dichlorvoswas not detected (detection limit was 1 μg/g) in the blood of 2 malevolunteers immediately after exposure to air concentrations of 0.25mg/m 3 (0.03 ppm) for 10 hours or to 0.7 mg/m3 (0.08 ppm) for 20hours (Blair et al., 1975). Low-level exposure and breakdown byesterases may account for nondetection of dichlorvos.” (Originals notsighted; ATSDR, 1997)The APVMA (2008b) reported:Dermal―A study (Kirkland, 1971) evaluated by the WHO (1988) demonstrated thatat dichlorvos concentrations of 0.1 – 2.0 mg/m 3 , [anaesthetised andtracheotomised] pigs retained 15 – 70% of the inhaled dichlorvos.‖(APVMA, 2008b)The APVMA (2008a) reported:― 14 C-dichlorvos (in water) was applied to the shaved backs of 12 rats/dose at3.6, 36 or 360 μg/animal (rates of 0.5, 3 and 30 μg/cm 2 , respectively). Theapplication site was 12 cm 2 and the total volume applied to each rat was 100μL. A substantial proportion of 14 C-dichlorvos (38-55%) evaporated fromthe skin surface following application. The total level of dermal absorptionwas 22-30% and was consistent over time and dose (0.5-30 g/cm 2 ).Absorption occurred within the first 10 hours of sample application, withthe actual amount of 14 C-dichlorvos absorbed increasing with dose. Theexcretion routes were via exhaled air (CO 2 ) (2.2-4.9%), urine (1-2%) andfaeces (0.1-0.6%). Blood levels decreased over time. Analysis of thestability of the test material lacked transparency and was somewhat difficultto follow in the study report. (Jeffcoat 1990).‖ (Originals not sighted;APVMA, 2008a)CalDRP (1996) reported the same study:―DDVP ( 14 C, 93% purity; 0, 0.3, 3.0, or 30 ug/cm 2 ) was applied dermally onrats (Jeffcoat, 1990). After 10 hours of exposure, the percent of dermalabsorption (determined by radioactivity in the carcass, blood, exhaled air,urine, feces, and cage rinses) ranged from 7.3 to 13.3% for all doses. Therewas no further absorption after 10 hours and up to 120 hours. The majorityof the applied dose (37.7- 51.6%) was lost to evaporation and trapped by acharcoal impregnated covering placed over the area. Washing of theexposed skin with soapy water removed 8.4-14.7% of the administereddose. Based on the results of this study, the DPR Worker Health and SafetyBranch recommended a dermal absorption factor of 13% for the estimationof potential human exposure.‖ (Originals not sighted; CalDPR, 1996)Dichlorvos reassessment – application Page 165 of 436

The US EPA (2006) reported that:4.2 Distribution:―The dermal absorption rate for dichlorvos was estimated to beapproximately 11% in 10 hours of exposure based on an acceptable dermalabsorption study in rats (MRID 41435201).‖ [MRID 41435201 is Jeffcoat,A. (1990) Dermal Absorption of Dichlorvos in Rats: Lab Project Number:4615. Unpublished study prepared by Research Triangle Institute. 196 p.]CalDRP (1996) reported:―Rats (Crl:CD (SD) BR) were given DDVP ( 14 C, purity not specified) eitheras a single intravenous dose (1 mg/kg [b.w.]), by gavage as a single dose(0.8 mg/kg [b.w.] or 21 mg/kg [b.w.]), or by gavage as multiple doses (0.8mg/kg [b.w.]) for 16 days (Cheng, 1989 and 1991). Radioactivity in thetissues and carcasses was determined 7 days after dosing. Urine, feces, andexhaled air as CO 2 were monitored for 7 days after dosing. Clinical signs,such as tremors and salivation, were observed 2.5 hours after gavage dosingin the 21 mg/kg [b.w.] group. There were no differences in the tissuedistribution and excretion patterns between the dosing regiment or sexes.Consistent with the earlier studies, the liver and kidneys contained higherlevels of radioactivity than other organs (lung, spleen, uterus, and bone). Forboth routes of administration, the percent of total dose excreted ranged from40 to 58% in the exhaled air, 10-17% in the urine, and 4-7% in the feces.The majority of the radioactivity in the exhaled air and excreta waseliminated within 24 hours after dosing. The major metabolites in the urineand feces were hippuric acid and urea. Glucuronide conjugates and otherdehalogenated products were not positively identified.‖ (Originals notsighted; CalDPR, 1996)The APVMA (2008a) reported:―Blair et al. (1975) examined the tissue distribution of dichlorvos inmammals following inhalational or intravenous administration. Rats wereexposed to dichlorvos vapour at 0.05 or 0.5 mg/m 3 (in open chambers for 14days), 50 mg/m 3 for 2-4 h[ours], or 10 or 90 mg/m3 for 4 h[ours] (head-onlyexposure). In addition, two male human subjects were exposed in a 20 m 3chamber to atmospheres containing 0.25 mg/m 3 dichlorvos for 10 h[ours] or0.7 mg/m 3 for 20 h[ours]. A separate group of rats was given a singleintraperitoneal injection of 0.83 mg/kg bw dichlorvos. No dichlorvos wasdetected in either of the two male subjects. At low concentrations (

4.3 Metabolism:found in tissues of rats exposed to 10 mg/m3 for 4 h[ours], or in blood ortissues exposed to 0.05 or 0.5 mg/m 3 for 14 days. Following intravenousinjection, little or no dichlorvos was found in rat liver, fat, testes or brain.Dichlorvos was detected in blood in only one of three rats at 10 and 30 minpostdose. Overall, the results indicated that dichlorvos was rapidlymetabolised in vivo.‖ (Originals not sighted; APVMA, 2008a)CalDRP (1996) reported:―After absorption, the primary site of metabolism was the liver, and themetabolism of DDVP was rapid. At 0.25 hour after treatment, the tissues(liver, kidneys, and blood) contained primarily hydrolysis products and lessthan 5% as DDVP. Radioactivity was also found in the bone which is likelydue to the deposition of phosphoric acid in the bone. Routes of excretion forDDVP were exhaled air, urine, and feces. After 24 hours, the percentage ofradioactivity in the exhaled air as CO 2 was 16%. Urinary metabolitesincluded desmethyl DDVP, mono- and dimethyl phosphates, inorganicphosphate, and dichloroethyl glucuronide. Over 80% of the radioactivity inthe urine collected 3 hours after treatment were mono- and dimethylphosphates. Only about 10% of the dose excreted in the feces was watersoluble DDVP derivatives. Other metabolites included inorganic phosphate,two-carbon fragments (glycine and serine), phosphate ions, and chlorideions.‖ (Originals not sighted; CalDPR, 1996)The APVMA (2008a) reported:―Hutson et al. (1971) investigated the metabolic fate of [ 14 C-vinyl]dichlorvos in rats following oral, inhalational and intraperitonealexposure. Respired air accounted for the greatest proportion of eliminated14 C and most was recovered within 24 hours following inhalationalexposure (head only). After 4 days, the highest tissue levels occurred in thecarcass and skin (~38 and 26%, respectively of the total amount of 14CO 2 ).Analysis of metabolites following oral dosing with [ 14 C-vinyl]-labelled or[ 36 Cl]-labelled dichlorvos detected free 36 Cl and at least 7 metabolites.Identified metabolites included hippuric acid (8.3%), desmethyl dichlorvos(10.9%) and dichloroethanol glucuronide (27%). The presence ofdichloroacetaldehyde could not be demonstrated. No parent compound wasidentified. The majority of 14 C in the livers from rats given a single oral doseof [ 14 C-vinyl]dichlorvos was detected in the protein fraction (as glycine andserine). Urinary metabolites detected following intraperitonealadministration of [ 14 C-vinyl]dichlorvos included hippuric acid anddesmethyl dichlorvos (2-5%) and dichloroethanol glucuronide (76%).Following inhalational exposure, identifiable urinary metabolites alsoincluded hippuric acid (9.3%) and desmethyl dichlorvos (4.3%), and urea(5.3%). No unchanged dichlorvos was found in the urine following dosingby either the oral or inhalational routes.‖ (Originals not sighted; APVMA,2008a)Dichlorvos reassessment – application Page 167 of 436

4.4 Elimination:CalDRP (1996) reported:―Rats (strain not specified) were given DDVP ( 14 C and 36 Cl, purity notspecified; 0.99 mg/male rat and 0.72 mg/female rat) by gavage (Hutson etal., 1971). Urine, feces, and exhaled air were collected every day for 4 days.Radioactivity in tissues was also determined. Additional female rats wereused for the determination of metabolites in the urine and the liver. Therewas no difference in the excretion patterns between sexes. After 4 days(daily result not given), the percentages of administered doses in the urine,feces, and exhaled air were 12.8-18.2%, 3.4-4.8%, 36.8-38.8%, respectively.The identified urinary metabolites included hippuric acid (8.3% of totalurinary radioactivity), desmethyl-DDVP (10.9%), and 2,2-dichloroethyl-Bd-glucopyranosiduronicacid (27%), while no unmetabolized DDVP,dichloroacetaldehyde or dichloroacetic acid was found. Of the tissuesexamined, the highest level of radioactivity (4.4-5.0% of dose) was in theliver. Analysis of the liver tissue showed that 75% of the radioactivity wasassociated with glycine, serine, and cystine in the protein hydrolysatefraction.‖ (Originals not sighted; CalDPR, 1996)The APVMA (2008a) reported:―In a series of experiments, [ 14 C-vinyl]dichlorvos was given by gavage tomale and female mice (0.2 mg, approximately 8 mg/kg bw), and Syrianhamsters (0.22-0.56 mg, approximately 4 mg/kg bw), and to 1 man orally (5mg in 100 mL orange juice, approximately 70 μg/kg bw) and another byinhalation (38 mg/m3 unlabelled dichlorvos for 105 min). Elimination ratesand urinary excretion were compared with results obtained from a secondexperiment using rats. Overall, the data indicated that the rates and routes ofelimination were largely similar (predominantly air and urine) in all speciesand there was no marked sex difference in laboratory animals. Followingoral dosing of mice and rats with [ 14 C-methoxy]dichlorvos, the majorurinary metabolite was dimethyl phosphate (~70% of urinary radioactivityand 40% of the dose). Desmethyl dichlorvos constituted 4% of total urinaryradioactivity in rats and 28% in mice. Minor metabolites present at less than2% of total urinary radioactivity were S-methyl-L-cysteine (both species),S-methyl-L-cysteine oxide and methylmercapturic acid (mouse only), andmethylmercapturic acid S-oxide (rat only). Two other minorchromatographic peaks could not be identified. Following oral dosing with[ 14 Cvinyl] dichlorvos hippuric acid, desmethyl dichlorvos and urea weredetected in the urine of mice and the man, with only hippuric acid measuredin hamsters. A dichloroethanol conjugate in the urine of the man exposed todichlorvos by inhalation was detectable but not quantifiable because ofinterference from endogenous peaks. (Hutson and Hoadly 1972a & b)‖(Originals not sighted; APVMA, 2008a)―Cheng (1989 & 1991) examined the metabolism and tissue distribution of[vinyl-1- 14 C] dimethyl dichlorovinylphosphate ( 14 C-dichlorvos) in rats. Fiverats/sex/group were administered 14 C-dichlorvos as a single intravenousDichlorvos reassessment – application Page 168 of 436

dose of 1.0 mg/kg bw, a single gavage dose of 0.8 or 21.0 mg/kg bw, or 15daily oral gavage doses of 0.8 mg/kg bw unlabelled dichlorvos followed bya single radiolabelled dose of 0.8 mg/kg bw on the 16th day. The controlgroup consisted of 2 untreated rats. The major route of excretion was viaexhaled CO 2 (40-58%) followed by the urine (10-15%) and faeces (4-7%).Excretion was rapid, occurring within the first 24 hours after dosing.Marked levels of 14 C (13-26%) remained in the carcass seven days afterdosing. Relatively low levels of 14 C were found in other tissues such as theliver (3.5-4.8%), blood (0.3-0.5%) and kidneys (0.2-0.5%). Excretion andtissue distribution appeared to be independent of dose route and sex. Severalradioactive metabolites were detected in urine, including urea (19-33%) andhippuric acid (3.78-19.5%). In faeces, numerous uncharacterised minormetabolites were detected in addition to hippuric acid (

5 ACUTE ORAL 6.1HSNO Classification: Acute oral - 6.1BKEY STUDY:• Type of study: LD 50 ;• Species:• Strain:• Sex/Numbers:Rat;Tif:RAI;5/sex/group;• Test Material: Dichlorvos tech. (purity/source unstated) in 2%carboxymethylcellulose (CMC);• Dose levels:• Endpoint:• Remarks:• LD 50 (mean) =• GLP:• Test Guideline:31.7 to 100 mg/kg b.w. by gavage;Observations for morbidity, mortality, injury & clinicalsigns were conducted. Necropsy examinations wereperformed on all animals found dead and all survivinganimals at the scheduled terminal necropsy;Adverse signs included dyspnoea, exophthalmus, curvedposition, trismus, tonic-clonic muscle spasms and ruffledfur, with these signs occurring at all dose levels within 2hours of administration. These signs increased in severitywith dose. All survivors recovered within 4 days. Grossexamination revealed no treatment-related changes.46.4 mg/kg b.w. (40.1-53.7 mg/kg b.w.), calculated byprobit analysis;No information;No information;• Reference source: Ciba-Geigy Ltd, Basle (1973) ―Acute oral LD 50 oftechnical dichlorvos (G177) in the rat.‖Toxicology/pathology PH 2.635. Report number Siss 3361Report date: 30 th August 1973. (Original not sighted.)(APVMA, 2008a);• Reliability:Klimisch score 2 = reliable with restrictions;Justification for Classification: Ciba-Geigy (1973) is not stated to have beenconducted to GLP or Test Guidelines, however the LD 50 value is in line with otherDichlorvos reassessment – application Page 170 of 436

eports. LD 50 = 46.4 mg/kg b.w. is in Category 6.1B as stated in Table 10.1 of theUser Guide to the Thresholds and Classifications in the HSNO Act (ERMA, 2008).BACKGROUND:The APVMA (2008a) reported:―Durham WF, Gaines TB, McCauley RH, Sedlak VA, Mattson AM & Hayes WJjr (1957) Studies on the toxicity of 0, 0-dimethyl-2,2-dichlorovinyl phosphate(DDVP). Arch Ind Health 15: 340-349. This published paper reported on a seriesof experiments that investigated a number of endpoints as well as acute oraltoxicity in rats. Dichlorvos was prepared in-house at the Technical DevelopmentLaboratories of the Communicable Disease Centre, Public Health Service, USDepartment of Health, Education and Welfare. Information on the purity of thetest material was not provided. Dichlorvos was given in peanut oil by gavage witha dose volume of 5 mL/kg bw to groups of white Sherman rats (group size notreported). LD50 values were 80 mg/kg bw (95% CI 62-104 mg/kg bw) in malesand 56 mg/kg (48-65 mg/kg bw) in females respectively. All animals that died didso within 1 h of dosing and complete recovery was observed in survivors within24 h. Adverse signs included bulging eyes, lachrymation, sialorrhoea, generalisedmuscle fasciculations and tremors. Convulsions were observed in some animalsprior to death. There was no apparent weight loss amongst survivors. Necropsyand pathology were not reported.‖ (Original not sighted; APVMA, 2008a)WHO (1992) reported:Acute oral toxicity of dichlorvos (WHO, 1988)SpeciesLD 50 (mg/kg b.w.)Mouse 68-275Rat 30-110Rabbit 13-23Cat 28Dog 100-316Chicken 15Swine 157Dichlorvos reassessment – application Page 171 of 436

The ATSDR (1997) reported:“A number of oral exposure LD50 studies have been done with dichlorvos inrats and mice. Based on reported LD50 values, dichlorvos is considered to beof moderate to high acute toxicity (WHO 1988). In the most extensive studyof this type, dichlorvos was one of 5 chemicals used in a study designed toinvestigate how well an experimentally derived LD50 value would predict thelevel that would result in 1% lethality (LDl value) for CD-l mice (Haley et al.,1975). The LD50 for male mice in this study was calculated to be 139 mg/kg[b.w.], and the LD50 for females was 133 mg/kg [b.w.]. In a subsequent studyat lower doses, the LDl for the male mice was 84 mg/kg [b.w.] (predicted LDlwas 81 mg/kg [b.w.]). In the female mice, the LDl was 95 mg/kg [b.w.](predicted LDl was 106 mg/kg [b.w.]). The authors further estimated an LD0.1of 70 mg/kg [b.w.] for male mice and 82 mg/kg [b.w.] for female mice. AnLD50 of 110 mg/kg [b.w.] was reported in male ICR mice (Takahashi et al.,1987). Dichlorvos administered by gavage in water at a dose of 150 mg/kg[b.w.] to male Swiss mice caused 100% lethality within 9 minutes(Mohammad et al., 1989).―In Sherman rats, oral LD50 values of 80 mg/kg [b.w.] in males and 56 mg/kg[b.w.] in females were reported (Durham et al., 1957). The LD 50 for female Wistarrats was reported to be 58.8 mg/kg [b.w.] (Gajewski and Katkiewicz 1981) and inmale Fischer 344 rats 97.5 mg/kg [b.w.] (Ikeda et al., 1990). Crossbred pigsweighing 12-27 kg treated with dichlorvos in gelatin capsules were reported tohave an LD50 of 157 mg/kg [b.w.] (Stanton et al., 1979).‖ (Original not sighted;ATSDR, 1997)Dichlorvos reassessment – application Page 172 of 436

6 ACUTE DERMAL 6.1HSNO Classification: Acute dermal – 6.1BKEY STUDY:• Type of study: LD 50 ;• Species:• Strain:• Sex/Numbers:• Test Material:• Dose levels:Rat;Sherman;Unstated number/sex/group;Dichlorvos tech. (purity/source unstated) in xylene;Unstated levels to clipped skin;• Endpoint: Mortality (LD 50 );• Remarks: All rats killed by a single dermal dose died within 20minutes of dosage, except a male dosed at 110 mg/kgb.w. that survived for 40 minutes and another maledosed at 125 mg/kg b.w. that survived for 17 days.The symptoms of poisoning observed were bulgingeyes, lacrimation, sialorrhea [excessive salivation],muscle fasciculations, and tremors. Some animals hadconvulsions just before death. Rats that survivedappeared to make a full recovery.• LD50 =• GLP:• Test Guideline:75 mg/kg b.w. in females; 107 mg/kg b.w. in males;No information;No information;• Reference source: Durham WF, Gaines TB, McCauley RH, et al. 1957.“Studies on the toxicity of O,O-dimethyl-2,2-dichlorovinyl phosphate (DDVP).” AMA Arch IndHealth 15:340-349. (Original not sighted.) (ATSDR,1997);• Reliability:Klimisch score 2 = reliable with restrictions;Justification for Classification: Durham et al. (1957) was not conducted to GLP, andno Test Guideline is reported (but pre-dated such requirements). However, the LD 50value is in line with other reports. LD 50 = 75 mg/kg bw is in Category 6.1B as statedDichlorvos reassessment – application Page 173 of 436

in Table 10.1 of the User Guide to the Thresholds and Classifications in the HSNOAct (ERMA, 2008).BACKGROUND:The APVMA (2008a) reported:―Tierfarm, Sissel, Switzerland (1969b) Report on the determination of the acutedermal LD 50 to the rat of DDVP technical. No Study/Report No. Lab/Sponsor:unspecified. Report date 10th July 1969. Dichlorvos (purity and source not given)was applied as a concentrate or dissolved in PEG (10% v/v) to a 10 cm 2 area ofthe shaved back of RAC rats (6/sex/group) at doses in the range 80-200 mg/kgbw. The skin was occluded with aluminium foil and sticking plaster for 24 h[our]before washing with warm water, and animals were observed for 7 days afteradministration. The LD 50 (males plus females) was 210 mg/kg bw, with mostdeaths occurring after 24 h[our]. No adverse signs were observed at 80 or 100mg/kg bw (in PEG). At 150 or 200 mg/kg bw (concentrate), adverse signs wereobserved within 15-30 minutes of application and included dose-dependenttrismus, tonic-clonic spasms of limb muscles, prostration, exophthalmus,dyspnoea, and lachrymation and secretion from the Hardersche (Harderian)glands. Symptoms persisted for up to 3 days but surviving animals recovered fullyafter 5-6 days. Necropsy of animals dying during the observation period revealedacute liver, spleen and kidney congestion, bloated intestines and inflamedperitoneum. Animals sacrificed after 7 days showed enlarged livers, and bloatedor slack intestines. No other macroscopic effects were reported. No skin irritationwas evident.‖ (Original not sighted; APVMA, 2008a)WHO (1992) reported:Acute dermal toxicity of dichlorvos (WHO, 1988)SpeciesRatThe ATSDR (1997) reported:LD 50 (mg/kg b.w.)75-107 (24 hours)Rabbit 205“In another LD50, study where dichlorvos was applied to female Wistar rats inethanol-water on depilated skin, an LD50 of 70.4 mg [/kg b.w.] dichlorvos wasfound (Gajewski and Katkiewicz 1981).” (Only details available, original notsighted; ATSDR, 1997)Dichlorvos reassessment – application Page 174 of 436

7 ACUTE INHALATION 6.1HSNO Classification: Acute inhalation - 6.1BKEY STUDY:• Type of study:• Species:• Strain:• Sex/Numbers:• Test Material:LC 50 (4 hours, head-only); vapour/aerosol;Rat;Wistar (Bor:WISW);5 (vapour) or 10 (aerosol)/sex/group;Dichlorvos (98.7 % pure, batch no. 809 436 388, lot no.3379);• Dose levels: Vapour: 342 mg/m 3 (nominal), 116 mg/m 3 (analysed) for 4hours;Aerosol: 230-1926 mg/m 3 for 4 hours;• Endpoint: Mortality (LC 50 );• Remarks:For the vapour experiment, 5 animals/sex were exposed for4 hours to a nominal concentration of 342 mg/m 3 (theanalysed concentration was 116 mg/m 3 , the maximumachievable as vapour). All animals showed adverse signsincluding bristling and ungroomed coat, reduced motilityand high gait but there were no deaths. No effects onweight gain were observed during the 14-day observationperiod and autopsy revealed no treatment-related grosseffects.A lethal vapour concentration could not be generated(maximum concentration was 116 mg/m 3 ); LC 50 > 116mg/m 3 (0.116 mg/L).In the aerosol experiment, 10 animals/sex were exposed tonominal air concentrations of 1500 - 15000 μL/m 3 (230-1926 mg/m 3 ) for 4 hours, with the particle mass mediandiameter ranging from 2.8 to 6.4 μm. Adverse signs,evident immediately after exposure (i.e. when rats wereremoved from tubes) were severe muscle tremors andweakness, convulsions, recumbence on side, ataxia, apathyand dyspnoea. More persistent signs included ungroomedcoat, bristling fur and high gait. All surviving animalsappeared to behave normally during the second week ofobservation. Body weight gain was normal. Animals thatdied during exposure showed a number of changes atDichlorvos reassessment – application Page 175 of 436

autopsy: distended lung; oedematous and pale, patchy liverwith lobulation; pale spleen and kidney; hyperaemia of theglandular stomach and serosa of the small intestine; andblood and mucus in the gut. No treatmentrelated grosseffects were observed in those animals surviving the 14-day observation period.• LC 50 (aerosol) = 523 mg/m 3 (95% CI 435-632) (0.523 mg/L) for males;447 mg/m 3 (379-529) (0.447 mg/L) in females;• GLP:Yes;• Test Guideline: Stated conforming to OECD [403?];• Reference source:• Reliability:Pauluhn J (1984) ―Dichlorvos (L15/20, DDVP) study foracute inhalation toxicity.‖ Report No. 13124;Lab/Sponsor: Bayer AG Institute of Toxicology,Wuppertal-Eberfeld. Report date: 12th December 1984.(Original not sighted.) (APVMA, 2008a);Klimisch score 2 = reliable with restrictions;Justification for Classification:Pauluhn J (1984) was stated to have been conductedto GLP and Test Guideline, with the APVMA concluding that the quality wasadequate to have confidence in the LC 50 values. The LC 50 values are in line withother reports. LC 50 (mist) = 0.447 mg/L is in Category 6.1B (as a mist) as stated inTable 10.1 of the User Guide to the Thresholds and Classifications in the HSNO Act(ERMA, 2008).BACKGROUND:The APVMA (2006a) reported:―Durham WF, Gaines TB, McCauley RH, Sedlak VA, Mattson AM & Hayes WJJr (1957) Studies on the toxicity of 0, 0-dimethyl-2,2-dichlorovinyl phosphate(DDVP). Arch Ind Health 15: 340-349.―Weanling Sherman rats (10/sex/group) were maintained for two weeks in Peet-Grady chambers that had previously been sprayed once with an emulsioncontaining 2.5% dichlorvos at a rate of approximately 100 or 195 mg dichlorvosper square foot (ie. equivalent to 9.29 or 18.12 mg/m 3 ). Air levels of dichlorvos inthe chamber sprayed at the lower rate ranged from 6 mg/m 3 at the start and 0.1mg/m 3 at the end of the two-week period. No adverse signs or body weightchanges were observed. Plasma and RBC ChE activities were slightly (

measured and it was not possible to determine the inhaled dose from the datapresented. Animals were supplied with food but not water and were removed fromthe chambers for 1 h[our]/day when water was supplied. Incoming and exhaust airwas monitored for dichlorvos by measuring total phosphorus. All animals in alltrials exposed to dichlorvos in the air died, with symptoms including slowlaboured respiration, sialorrhoea and paleness of ears and feet. Under the mostsevere exposure, these signs appeared within 2 h[ours], with average survival time6.9 and 10.1 h[ours] in males and females respectively.―Kimmerle G (1966) Letter re. DDVP (Lo-No. 271) inhalation study. Bayer AGInstitute of Toxicology, 56 Wuppertal-Elberfeld. Ref. Dr.Ki/Sp dated 7thDecember 1966.―A single-page note reported on the LC 50 of dichlorvos in male rats (the sourceand purity of dichlorvos and strain of rat were not provided). Groups of 20animals were exposed to analysed dichlorvos aerosol concentrations of 0.209-1.244 mg/L for 1 h[our], or 0.063-0.544 g/L for 4 h[ours]. In addition, 2 groups ofrats received (theoretical) 0.049 or 0.109 mg/L for 4 h[ours]/d[ay] for 5consecutive days. The 1-h[our] LC 50 was 0.455 mg/L (455 mg/m3), and the 4-h[our] LC 50 was 0.340 mg/L (340 mg/m3). Adverse signs were observed in 3/20rats at 0.319 mg/L and in most animals exposed to 0.479 mg/L or more for 1 h,and in all animals exposed to 0.082 mg/L or more for 4 h[ours]. There were noclinical signs and no animals died in the repeat-dose section of the study.―Macdonald R (1982) Toxicology of consumer products: the acute (4 h)inhalation toxicology of dichlorvos in rats and mice. Document No SBGR.82.145.Lab: Shell Research Ltd, Sittingbourne, UK. Sponsor: Temana. Report date:March 1982 QA study.―Groups of 10 animals (5/sex, CF1 mice and Wistar rats, both from Shell'sTunstall Laboratory) were subjected to head-only exposure to vapour containingdichlorvos (Windmill Plastics Ltd; batch No. ST82/016; 97.8% purity) for 4h[ours]. Observations on health and behaviour were made during and for 14 daysafter exposure. All mice exposed to 218 mg/m 3 (the only dose tested) survived.Adverse signs were body tremors and lethargy, with 3 mice displaying hind limbparesis and all showing splayed gaits. The clinical signs reversed by the secondday. In male rats, 3/10 animals exposed to 250 mg/m 3 (saturated air) died while all10 animals exposed to 210 mg/m 3 died. Subsequent exposure to 142 and 85mg/m 3 resulted in one male death at the lowest concentration. Two furtherexperiments were performed, using concentrations of 206 and 198 mg/m 3 , with nodeaths observed. Adverse signs in rats were observed at the highestconcentrations, and included ataxia and hypersensitivity to noise, both clearingrapidly after exposure. Lethargy persisted for up to 3 days in survivors. Dead ratsshowed signs of respiratory failure but no treatment-related effects were seen insurvivors sacrificed after 14 days. In conclusion, the LC 50 (4 h[our]) fordichlorvos in mice was >218 mg/m 3 and in rats was >206 mg/m 3 . Considerablevariability was evident, with all animals exposed to 210 mg/m 3 dying but nodeaths observed at 206 mg/m 3 .‖ (Originals not sighted; APVMA, 2006a)WHO (1992) reported:Dichlorvos reassessment – application Page 177 of 436

Acute inhalation toxicity of dichlorvos (WHO, 1988)Species Mode of exposure Time of exposure(hours)LC 50 (μg/L)Mouse Whole body 4 13Head only 4 > 218Rat Whole 4 15Whole 1 140Head 4 340Head 1 455Head 4 > 198Dichlorvos reassessment – application Page 178 of 436

8 SKIN IRRITATION 6.3 & CORROSION 8.2HSNO Classification: Skin irritation – 6.3BKEY STUDY:• Type of study:• Species:• Strain:• Sex/Numbers:• Test Material:• Dose levels:• Endpoint:• Remarks:Primary dermal irritation;Rabbit;Hacking and Churchill, New Zealand White (HC:NZW);3/group (sex unstated);Dichlorvos (batch no. 809 436 455, 97.3% pure);500 μL for 4 hours;Skin reactions (erythema and oedema);Groups of 3 HC:NZW rabbits (from Hacking andChurchill, Huntingdon, UK) were shorn over areas of theirflanks and exposed to 2.5 x 2.5 cm cellulose squares towhich water (control) or 500 μL dichlorvos (batch no. 809436 455, 97.3% pure) had been applied. After 4 hours thedressings were removed and areas washed with water; skinreactions where scored after 1, 24, 48 and 72 hours, and 7and 14 days.Easily perceptible redness (erythema grade 2) and slightswelling (oedema grade 1) were identified in all threerabbits during the first 48 hours after exposure. Thisdeclined in 2 rabbits to erythema grade 1 after 7 days butincreased to grade 3 (moderate) in the third. After 14 daysthis rabbit showed slight erythema (grade 1) with no othereffects evident in other animals.[The mean Draize score (erythema) ≥ 1.77 ≤ 2.1]Overall, dichlorvos was slightly irritating to rabbit skin;• GLP:No information;• Test Guideline: OECD 404;• Reference source:Pauluhn J (1985) ―L 15/20 (DDVP) technical activeingredient (c.n. dichlorvos): Study for irritant/corrosiveeffect on skin and eye (rabbit).‖ Report No. 13500.Lab/Sponsor: Bayer AG Institute of Toxicology,Dichlorvos reassessment – application Page 179 of 436

Wuppertal-Elberfeld. Report date: 22nd May 1985.(Original not sighted.) (APVMA, 2008a);• Reliability:Klimisch score 2 = reliable with restrictions;Justification for Classification: Pauluhn J (1985) was conducted to Test Guideline,but the GLP status was not confirmed. The mean Draize score (erythema) wasgreater than the minimum threshold for 6.3B as stated in Section 11.2 of the UserGuide to the Thresholds and Classifications in the HSNO Act (ERMA, 2008).BACKGROUND:Cal DPR (1996) reported that DDVP technical was a ―mild‖ dermal irritant to rabbits.WHO (1988) reported:―A primary skin irritation test on dichlorvos was performed by using male NewZealand white rabbits. Irritation observed on the skin after the application of 5 -20% water solutions of dichlorvos was relatively severe compared with thatcaused by other organophosphorus insecticides (Arimatsu et al., 1977).‖ (Originalnot sighted in WHO, 1988)Dichlorvos reassessment – application Page 180 of 436

9 EYE IRRITATION 6.4 & CORROSION 8.3HSNO Classification: Eye irritation – 6.4AKEY STUDY:• Type of study:• Species:• Strain:• Sex/Numbers:• Test Material:• Dose levels:• Endpoint:• Remarks:Primary eye irritation;Rabbit;Hacking and Churchill, New Zealand White (HC:NZW);6/group (sex unstated);Dichlorvos (batch no. 809 436 455, 97.3% pure);100 μL for 24 hours;Ocular reactions (irritation of the cornea, iris andconjunctiva);100 μL of dichlorvos was applied to the conjunctival sacof one eyelid of 6 rabbits, the eyelid was held shut for onesecond [and released] and washed with saline 24 hourslater. Cornea and iris findings were obtained optically, andthe corneal area affected was determined using a drop of1% fluorescein applied to the eye after 24 hours.Adverse signs were observed in all rabbits immediatelyafter administration. These included miosis, muscularfasciculations, tremor, staggering gait and recumbence onstomach, cyanosis, hyper salivation, tachypnoea andbronchosecretion. One male rabbit died 25 minutes afteradministration. Corneal opacity was evident, graded aslight and affecting up to 3/4 of the cornea, in all rabbitsduring the first 72 hours. Conjunctival redness andswelling, and increased tear flow was also observed in allanimals, generally graded as slight to pronounced (grade 1-3). Little effect on the iris reaction to light was observed.All surviving animals had recovered within 14-21 daysafter administration.Under the conditions of this study, dichlorvos was a severeeye irritant in rabbits;• GLP:No information;• Test Guideline: OECD 405;Dichlorvos reassessment – application Page 181 of 436

• Reference source:• Reliability:Pauluhn J (1985) ―L 15/20 (DDVP) technical activeingredient (dichlorvos): Study for irritant/corrosive effecton skin and eye (rabbit).‖ Report No. 13500. Lab/Sponsor:Bayer AG Institute of Toxicology, Wuppertal-Elberfeld.Report date: 22nd May 1985. (Original not sighted.)(APVMA, 2008a);Klimisch score 2 = reliable with restrictions;Justification for Classification: Pauluhn J (1985) was conducted to Test Guideline,but the GLP status was not confirmed. The level of reported injury was more thanthe minimum threshold as stated in Section 12.2 of the User Guide to the Thresholdsand Classifications in the HSNO Act (ERMA, 2008).BACKGROUND:Cal DPR (1996) reported that DDVP technical was a ―mild‖ eye irritant to rabbits.Dichlorvos reassessment – application Page 182 of 436

10 RESPIRATORY SENSITISATION 6.5AHSNO Classification: Respiratory sensitisation – Insufficient dataKEY STUDY: None.BACKGROUND:No appropriate studies or other relevant data were reported by APVMA (2008a), WHO(1988 & 1993), Cal DPR (1996) or ATSDR (1997) in their reassessments of dichlorvos.Dichlorvos reassessment – application Page 183 of 436

11 CONTACT SENSITISATION 6.5BHSNO Classification: Contact sensitisation – 6.5BKEY STUDY:• Type of study:• Species:• Strain:• Sex/Number:• Test Material:• Dose levels:• Endpoint:• Remarks:Maximisation Test;Guinea pig;Dunkin-Hartley;9 females/group;Dichlorvos (source, purity unstated);Induction: 25% dichlorvos;Challenge: 0.005, 0.05 or 0.5% dichlorvos;Skin reactions (erythema and oedema);Nine Dunkin-Hartley female guinea pigs (300-400 g b.w.)were induced topically with 25% dichlorvos underoccluded conditions. Animals were then challenged with0.005, 0.05 or 0.5% dichlorvos and any skin reactionsscored at 24 and 48 hours according to the procedure ofKligman (1966).At 24 hours post-challenge, 0, 56 and 100% of guinea pigstested positive at 0.005, 0.05 or 0.5% dichlorvos,respectively, decreasing to 0, 22 and 67%, respectively, at48 hours. There was a dose-related increase in the grade ofthe reaction.Dichlorvos is concluded to be a skin sensitiser in guineapigs;• GLP:• Test Guideline:No information;No information;• Reference source: Ueda A, Aoyama K, Manda F, Ueda T & Kawahara Y(1994) ―Delayed-type allergenicity of triforine (Saprol®).‖Contact Dermititis 31:140-145. (Original not sighted.)(APVMA, 2008a);• Reliability:Klimisch score 2 = reliable with restrictions;Dichlorvos reassessment – application Page 184 of 436

Justification for Classification: Ueda et al. (1994) was a published study, althoughTest Guideline and GLP status were not reported. The positive response rate wasmore than the minimum threshold as stated in Section 13.2 of the User Guide to theThresholds and Classifications in the HSNO Act (ERMA, 2008), so dichlorvosshould be classified 6.5B for contact sensitisation.BACKGROUND:The APVMA (2008a) reported:―Ueda A, Aoyama K, Manda F, Ueda T & Kawahara Y (1994) Delayed-typeallergenicity of triforine (Saprol®). Contact Dermititis 31:140-145.“Humans: The delayed-type allergenicity of seven pesticides (triforine,dichlorvos, chlorothalonil, quinomethionate, cyhexatin, methomyl and benomyl)and chrysanthemum extracts (known to induce contact dermatitis due to theirsesquiterpene lactones) were studied in 59 male and 48 female chrysanthemumgrowers following the spring harvest season. The average age of males was38.6+11.8 years and the average age of females was 42.2+9.6 years. Subjects hadworked in flower growing for an average of 14 years and had reportedly beenexposed to a range of pesticides. Health information was obtained usingquestionaires (work-related allergies, family history of allergies and general healthinformation). Patch testing of the 7 pesticides and extracts was performed on theinner side of the forearm and reactions read after 2 days. Subjects were alsoanalysed for serum immunoglobulins (IgE, IgA, IgG and IgM).―Approximately 60% of subjects were reported to have one or more work-relatedallergic symptoms (immediate-type or delayed-type), 25% had a personal historyof allergic diseases and 26% a family history of allergic disease. Of the 27% ofsubjects who reported experiencing work-related skin conditions, approximatelyhalf attributed this to pesticides. Pesticides thought to be causative factorsincluded dichlorvos, chlorothalonil, methomyl, maneb and macozeb. Twentypercent of males and 44% of females patch-tested positive to at least one or moreof the compounds. When subjects were patched tested with 0.02% dichlorvos,10% of males (6/59) and 19% of females (9/48) exhibited a positive reaction(average of 14%). On this basis, dichlorvos is concluded to be a skin sensitiser inhumans.‖ (Originals not sighted; APVMA, 2008a)The ATSDR (1997) reported:“A 52-year-old male truck driver who had been hauling pesticide containerspresented with dermatitis of his neck, anterior chest, dorsal hands, andforearms (Mathias 1983). On the previous day, several containers spilled inhis truck, and he apparently had direct dermal contact with a pesticidecontaining 5% dichlorvos, 15% petroleum distillates, and 80%trichloroethane. A faint papular dermatitis was present over the dorsal arms,hands, and V of the neck. .Vertical erythematous, slightly scaling streaks werepresent over the lateral and posterior neck, a pattern suggesting that liquiddroplets had produced the dermatitis. The dermatitis was treated with 1%hydrocortisone ointment. Follow-up examination six weeks later showedDichlorvos reassessment – application Page 185 of 436

persistent vertical, mildly erythematous streaks over the posterior andlateral neck; the arms and anterior chest had cleared. Negative patch testresults suggested that the dermatitis resulted from a primary irritant effect ofdichlorvos on the skin. Dermatitis resolved completely approximately 10weeks after onset. The persistence of dermatitis 2 months after exposure isvery unusual, and the author suggested that this may be related to someunique local toxic effect of dichlorvos, but did not speculate further.“In a guinea pig maximization test conducted in this study, induction withdichlorvos by intradermal injection and topical application and subsequentchallenge with topical dichlorvos solutions showed sensitization, thethreshold irritation concentration of dichlorvos on guinea pig skin wasreported to be 1% (Ueda et al., 1994). Cross-reactivity with dichlorvos wasdemonstrated in animals induced with triforine.” (Originals not sighted;ATSDR, 1997)WHO (1988) reported:―In order to study the allergenicity of dichlorvos, the guinea-pig maximizationtest was used. Threshold limit values of primary irritancy tested on the skin ofguinea-pigs (Hartley strain) were 2% or more. In the maximization test, 0.05 and0.5% were used. With 0.5%, 35% of the animals showed slight or discreteerythema. The allergenicity rating as determined by the Kligman test wasmoderate. In combination with methidathion, dichlorvos showed a strongerreaction, indicating cross-sensitization (Fujita, 1985).‖ (Originals not sighted;WHO, 1988)Dichlorvos reassessment – application Page 186 of 436

12 MUTAGENICITY 6.6HSNO Classification: Mutagenicity – 6.6BKEY STUDY: NoneAs the classification for mutagenicity is based on the total weight of evidence available,there is no single key study.The minimum degrees of hazard criteria for mutagenicity lists a hierachy of evidence(study types): mutagenic effects as a result of mammalian in vivo exposure; genotoxiceffects as a result of mammalian in vivo exposure, with mutagenic effects as a result ofin vitro exposure; and, mutagenic effects as a result of in vitro exposure of mammaliancells, and the substance has a structure-activity relationship to known germ cellmutagens.Justification for Classification:Weight of evidence: There is an extensive genotoxicity database for dichlorvos.Negative results were reported in in vivo host-mediated, dominant lethal, sisterchromatid exchange and micronucleus assays (except on skin after local application atcytotoxic doses). Dichlorvos was reported not to induce in vivo chromosomalaberrations in bone-marrow cells, spermatocytes or spermatogonia, DNA strand breaksor unscheduled DNA synthesis. The negative in vivo genotoxicity results wereexplained by the rapid metabolism and inactivation of dichlorvos, which appears toprevent systemic exposure to intact dichlorvos at concentrations likely to lead to directmolecular interactions.However, dichlorvos has genotoxic potential at localised high concentrations and in theabsence of metabolism, demonstrated by micronucleus formation in mouse epidermalkeratinocytes after direct application of dichlorvos to the skin; an increase in themutation frequency in the liver of transgenic mice following repeated intraperitonealinjection; and, an increased incidence of hair follicle nuclear aberrations (NA) in CD1mice after a single application at 1/8 th the dermal LD 50 .Dichlorvos was mutagenic and DNA-reactive in bacteria and other microorganisms invitro, in both the presence and absence of exogenous metabolic activation (althougheffects were commonly reduced in the presence of exogenous metabolic activation).Dichlorvos was also mutagenic and clastogenic in a range of mammalian cells exposedin vitro, including induction of UDS but not chromosomal aberrations or SCE incultured human cells.Dichlorvos is an electrophile and stated to possess a structural alert formethylating activity. While dichlorvos possesses methylating activity, thephosphorous atom of the molecule is reported to be a stronger electrophile thanthe methyl carbon atoms (phosphorylating reactivity). In tissues and blood,dichlorvos is much more likely to react with “A”-type esterases, serumcholinesterase, or acetylcholinesterase than with DNA (ATSDR, 1997; APVMA,2008a).Dichlorvos reassessment – application Page 187 of 436

In summary, dichlorvos is mutagenic and clastogenic at the point of contact, whereunchanged dichlorvos may be in direct contact with tissue [DDVP‘s inherent potential].There is no evidence that dichlorvos has any systemic genotoxic potential, due to thesubstance‘s inherent phosphorylating reactivity and the highly efficientbiotransformation [low risk]. Dichlorvos should be Classified as 6.6B, as the evidencemeets the criteria in Section 14.2.2 of the User Guide to the Thresholds andClassifications in the HSNO Act (ERMA, 2008). However, the lack of systemicgenotoxic potential should be accounted for in any human risk assessment.Dichlorvos is proposed for classification for Carcinogenicity (6.7B), based on the dataavailable for this review (see Section 13 Carcinogenicity 6.7 below).The 6.6B Classification for mutagenicity is consistent with conclusions from reviews bythe APVMA and ASTDR.BACKGROUND:The APVMA (2008a) reported the following in vivo and in vitro assays (Originals notsighted):Dichlorvos reassessment – application Page 188 of 436

ERMA New Zealand CONFIDENTIAL Report ID: dichlorvos_RA_ClassJune 2009 Dichlorvos Re-assessment – Review of Tox. & Classes 6 & 8 Page 189 of 436

The APVMA (2008a) summarised:―Numerous in vitro and in vivo experiments have tested the genotoxic potential ofdichlorvos, with the majority of data generated between 1972 and 1990 andpublished in the open scientific literature. In the current submission, sevenunpublished genotoxicity studies were evaluated, which showed that dichlorvoswas genotoxic in vitro but not in vivo. These findings are consistent with theextensive genotoxicity database for dichlorvos.―Dichlorvos is mutagenic and DNA-reactive in bacteria and other microorganismsin vitro, in both the presence and absence of exogenous metabolic activation(although effects were commonly reduced in the presence of exogenous metabolicactivation). Dichlorvos is also mutagenic and clastogenic in a range ofmammalian cells exposed in vitro, including induction of UDS but notchromosomal aberrations or SCE in cultured human cells. In contrast, the majorityof in vivo studies, including tests for induction of UDS, SCE, micronucleusformation, chromosomal aberrations and dominant lethal mutations, have yieldednegative results. These negative in vivo genotoxicity results can be explained bythe rapid metabolism and inactivation of dichlorvos, which appears to preventsystemic exposure to intact dichlorvos at concentrations likely to lead to directmolecular interactions.―Tungul et al. (1991) described micronucleus formation in mouse epidermalkeratinocytes after direct application of dichlorvos to the skin, confirming thatdichlorvos has genotoxic potential at localised high concentrations and in theabsence of metabolism. Pletsa (1999) reported a 3-fold increase in the mutationfrequency in the liver of transgenic mice following repeated intraperitonealinjection of dichlorvos. In this same study, a single injection failed to have aneffect, while neither single nor repeated administration generated methylatedDNA adducts or increased the frequency of mutations in other tissues. Thesefindings are consistent with increased tumours (mostly papillomas) observed inthe forestomach of mice, where tissue was exposed to high concentrations ofunchanged dichlorvos (NCI 1977; Chan 1989).―The extensive genotoxicity database indicates that in the absence of metabolism,dichlorvos is mutagenic and clastogenic at the point of contact, where unchangeddichlorvos may be in direct contact with tissue. There is no evidence thatdichlorvos has any systemic genotoxic potential. Scenarios of prolonged exposurein the absence of metabolic activity are unlikely in the general population giventhe current patterns of use. Chronic inhalational exposure (the most likelyexposure route in humans) failed to cause tumours (Blair et al., 1974) or tomethylate nucleic acids in rats (Wooder et al., 1976). The failure of dichlorvos tomethylate DNA or RNA in vivo has been attributed to its phosphorylatingreactivity, leading to highly efficient biotransformation (Wright et al., 1979).Furthermore, the consistently negative in vivo genotoxicity findings consequentwith rapid metabolism indicate that dichlorvos is unlikely to pose a genotoxic riskto humans.‖ (Originals not sighted; APVMA, 2008a)Dichlorvos reassessment – application Page 190 of 436

The ATSDR (1997) reported:“Dichlorvos is an electrophile and possesses a structural alert for methylatingactivity. Dichlorvos has been tested for genotoxicity in a number of in vivoand in vitro systems. In general, dichlorvos was not genotoxic in in vivostudies but was generally genotoxic or mutagenic in in vitro tests whenmetabolizing enzymes (S9 fraction) were not present.“In the sex-linked lethal mutation test in Drosophila melanogaster,dichlorvos gave negative results when the flies were exposed by inhalation(Jayasuriya et al., 1973; Sobels and Todd 1979). Multiple generations of fliesexposed to food containing dichlorvos for 18 months had increasedmutations (Hanna and Dyer 1975). Salivary gland chromosome abnormalitieswere reported in larvae fed 1 ppm dichlorvos in food in one study (Gupta andSingh 1974), while another study at lower levels showed no effect (Kramersand Knaap 1978).“No dominant lethal mutations were reported in ICR mice given a singleintraperitoneal dose or consecutive daily doses of 5 or 10 mg/kg [b.w.] orally(Epstein et al., 1972). In a similar study where dichlorvos was administeredby inhalation (30 or 55 mg/m 3 (3.3 or 6.1 ppm) to CF-1 mice, no dominantlethal mutations were observed (Dean and Thorpe 1972).“Male Q strain mice which received drinking water containing 2 mg/Ldichlorvos for 7 weeks did not show chromosome damage in bone marrowcells, spermatogonia, or primary spermatocytes (Moutschen-Dahmen et al.,1981). In a micronucleus test, Swiss mice given daily intraperitonealinjections of dichlorvos (0.0075 or 0.015 mg/kg [b.w.]) for 2 days showed noaberrations in structure or number of chromosomes in bone marrow cells.CF-1 mice exposed to 64-72 mg/m3 for 16 hours or to 5 mg/m3 for 21 daysdid not show chromosome abnormalities (Dean and Thorpe 1972). In Syrianhamsters, however, intraperitoneal injections at 3, 6, 15, and 30 mg/kg [b.w.]did cause increases in the number of cells with aberrant chromosomes(Dzwonkowska and Hubner 1986).“Dichlorvos was positive for binding to calf thymus DNA in vitro (Lofroth1970; Segerbeck 1981). Dichlorvos was negative for DNA binding in vivo inrats (Wooder et al., 1977) and in mice (Segerbeck 1981).“In mutagenicity tests with S. typhimurium tester strains, dichlorvos hasgenerally been positive without metabolic activation and negative in thepresence of S9. Dichlorvos in the presence of metabolic activation wasnegative in strains TA 98 (Braun et al., 1982), TA 1535 (Braun et al., 1982;Carere et al., 1976; Moriya et al., 1978) and TA 1536, 1537, and 1538 (Braunet al., 1982; Carere et al., 1976). Without metabolic activation, dichlorvos waspositive in strain TA 100 (Moriya et al., 1978), strain 1530 (Hanna and Dyer1975), strain 1535 (Carere et al., 1978; Hanna and Dyer 1975; Moriya et al.,1978; Shirasu et al., 1976), but negative in strains 1536, 1537, and 1538(Moriya et al., 1983; Shirasu et al., 1976).Dichlorvos reassessment – application Page 191 of 436

“The lack of dichlorvos genotoxicity in in vivo studies is most likely due to thefact that while dichlorvos possesses methylating activity, the phosphorousatom of the molecule is a stronger electrophile than the methyl carbon atoms(Wright et al. 1979). In tissues and blood, dichlorvos is much more likely toreact with “A”-type esterases, serum cholinesterase, or acetylcholinesterasethan with DNA (WHO 1989).” (Originals not sighted; ATSDR, 1997)WHO (1993) reported:―Mice were given i.p. injections of methyl- 14 C-dichlorvos (1.9 µmol/kg bw,approximately 420 µg/kg bw). The degree of alkylation of guanine-N-7 in DNAisolated from soft tissues amounted to 8 x 10 -13 mol methyl per gram of DNA(about 5 x 10 -10 mol/mol guanine) (Segerback, 1981; Segerback & Ehrenberg,1981). From acute toxicity data in mouse it can be extrapolated that this dosewould cause 1 mol/mol phosphorylation of erythrocyte ChE.―DNA and RNA from the total soft tissues of male rats exposed to atmospherescontaining 0.064 mg/m 3 (about 0.1% of the LC 50 ) of methyl- 14 C-dichlorvos for 12hours did not show methylation of the N-7 atom of guanine moieties. Theexposure period constituted a significant fraction of the half-life of the 7-methylguanine moieties in DNA (Wooder et al., 1977; Wooder & Wright, 1981).―Excretion of labelled 7-methylguanine in the urine by NMRI mice and ratsinjected i.p. with [Me- 14 C]-dichlorvos, or exposed by inhalation for 2 hours (miceonly) was reported by Wennerberg & Lofroth (1974) and Lofroth & Wennerberg(1974). In rat urine, labelled 3-methyladenine and 1-methyl-nicotinamide werealso present (Lofroth & Wennerberg, 1974). According to the authors, theseresults demonstrate that dichlorvos spontaneously methylates guanine and adeninemoieties in nucleic acids. However, administration of radiolabelled adenine andguanine to otherwise untreated rats gave rise to the excretion of radiolabelledmethylated purines in the urine. Therefore, the detection of radiolabelled purines,per se, in the urine of animals exposed to methyl-labelled methylating agents doesnot constitute evidence for the spontaneous methylation of the purine moieties ofnucleosides or nucleic acids by methylating agents (Wooder et al., 1978; Wooder& Wright, 1981). Moreover, a natural biosynthetic pathway has beendemonstrated whereby the methyl carbon atoms of dichlorvos can be incorporatedinto the heterocyclic rings and the methyl groups of urinary 7-methylguanine afterentering the 1-C pools, in vivo (Wright et al., 1979; Wooder & Wright, 1981).‖(Originals not sighted; WHO, 1993)―In Drosophila melanogaster, chromosomal aberrations but not sex-linkedrecessive lethal mutations were induced. Negative results were obtained in hostmediated,dominant lethal, sister chromatid exchange and micronucleus assays(except on skin after local application at cytotoxic doses). Dichlorvos did notinduce in vivo chromosomal aberrations in bone-marrow cells, spermatocytes orspermatogonia, DNA strand breaks or unscheduled DNA synthesis.‖ (Originalsnot sighted; WHO, 1993)The genotoxicity database available for dichlorvos was also summarised by:Dichlorvos reassessment – application Page 192 of 436

•ATSDR (1997): http://www.atsdr.cdc.gov/toxprofiles/tp88.html•WHO (1993): http://www.inchem.org/documents/jmpr/jmpmono/v93pr05.htm•CCRIS (2008): http://toxnet.nlm.nih.gov/cgi-bin/sis/search - dichlorvosContact genotoxicity of dichlorvosA. Tungul, A.M. Bonin, S. He1 and R.S.U. Baker2Mutagenesis vol. 6 no. 5 pp. 405-408, 1991“Micronuclei induction by dichlorvos in the mouse skin”Toxicology Unit, National Institute of Occupational Health and Safety GPO Box 58,Sydney, New South Wales 2001, Australia 1 Guangxi Medical College Nanning,Guangxi, People's Republic of ChinaMicronucleus (MN) induction in cultured keratinocytes was investigated following skinpainting of HRA/Skh mice with the pesticide, dichlorvos. Whole skin and partiallypurifiedepidermal cells from 5–6 week old male animals were cultured for 4 days invitro after single topical applications of various concentrations of dichlorvos in vivo.Appropriate doses, allowing optimum survival of keratinocytes, were selected followingan initial range-finding experiment. To evaluate MN induction in dividing cells, thecytokinesis-block method was employed. Results showed statistically significant MN atall dose levels in partially-purified epidermal cells and a positive trend with respect todose from 51 to 1033 nmol dichlorvos. A significant increase in MN was also detectablein cultured cells from whole skin, dissociated within as little as 1 h after application ofdichlorvos. Although a number of technical difficulties are associated with the skinmicronucleus method, it has been used successfully in this laboratory to detect severalskin carcinogens of both high and low potency. Since dichlorvos is rapidly absorbedthrough the skin, and can induce MN in skin cells of treated mice, this compound maytherefore be considered to pose a contact hazard for exposed humans.Pletsa V, Steenwinkel MJ, van Delft JH, Baan RA, Kyrtopoulos SA.Cancer Lett. 1999 Nov 15;146(2):155-60―Induction of somatic mutations but not methylated DNA adducts in lambdalacZtransgenic mice by dichlorvos.‖Laboratory of Chemical Carcinogenesis, Institute of Biological Research andBiotechnology, National Hellenic Research Foundation, Athens, Greece.In order to examine the in vivo genotoxic activity of dichlorvos, lambdalacZ transgenicmice (Muta Mouse) were treated i.p. with single (4.4 or 11 mg/kg [b.w.]) or multiple (5x 11 mg/kg [b.w.]) doses of this agent and sacrificed 4 h or 14 days post-treatment forDNA adduct measurement or mutant frequency analysis, respectively. Neithermethylated DNA adducts nor an increase in mutant frequency were detected in the bonemarrow, white blood cells, liver, spleen, lung, brain and sperm cells after the singledoses. However, following multiple dosing a statistically significant 3-fold increase inmutant frequency was observed in the liver, while a non-statistically significant increasewas observed in the bone marrow. In contrast, dimethylsulphate, a model methylatingagent, gave rise to detectable DNA adducts but no increase in mutant frequencyDichlorvos reassessment – application Page 193 of 436

following i.p. administration of single (30 mg/kg [b.w.]) or multiple (10 x 6 mg/kg[b.w.]) doses.Schop RN, Hardy MH, Goldberg MT.Fundam Appl Toxicol. 1990 Nov;15(4):666-75.―Comparison of the activity of topically applied pesticides and the herbicide 2,4-D intwo short-term in vivo assays of genotoxicity in the mouse.‖Department of Biomedical Sciences, University of Guelph, Ontario, Canada.Genotoxicity of eight topically applied compounds was determined using the bonemarrow micronucleus (MN) test and hair follicle nuclear aberration (NA) assay in CD1mice. Twenty-four hours after a single treatment, cyclophosphamide (CY), applied atdoses corresponding to 1/4, 1/8, 1/16, and 1/32 of the published dermal LD50, and N-methyl-N-nitrosourea (MNU), applied at 1/4, 1/8, and 1/16 of the published dermalLD50, were found to increase the incidence of NA in a dose-dependent manner. Thefrequency of MN was significantly increased only at the highest dose of CY. Using thesame protocol, six pesticides applied in dimethyl sulfoxide (DMSO) at doses of 1/8,1/16, and 1/32 of the dermal LD50 were investigated. Aminocarb and chlordaneinduced a dose-dependent increase in the frequency of NA, while there was an observedincrease in NA incidence at only the highest doses of dichlorvos (DDVP), 4,4'-DDT(DDT), and 2,4-dichlorophenoxyacetic acid (2,4-D). No effect was observed withfenitrothion on nuclear aberrations in hair follicles. Except for the highest dose ofchlordane, none of the pesticides tested positive in the bone marrow micronucleus test.Serum cholinesterase levels were reduced to 70 +/- 4.7% of the DMSO control levelwith DDVP, 57 +/- 8.2% with aminocarb, and 60.3 +/- 4.8% with fenitrothion,indicating some systemic activity with these topically applied agents. The data suggestthat aminocarb, chlordane, DDVP, DDT, and 2,4-D are genotoxic as determined by theNA assay and that this assay may be more useful in detecting topically appliedgenotoxic agents than the more often used bone marrow micronucleus test.[Note: the hair follicle nuclear aberration (NA) assay is not currently an acceptedguideline test.]Dichlorvos reassessment – application Page 194 of 436

13 CARCINOGENICITY 6.7HSNO Classification: Carcinogenicity – 6.7BKEY STUDY:• Type of study:• Species:• Strain:• Sex/Numbers:• Test material:Rat combined (chronic toxicity and carcinogenicity);Rat;Fischer 344/N;50/sex/group;Dichlorvos (batch No. SDC 092179; 99% purity);• Dose levels: 0, 4 or 8 mg/kg b.w./day in corn oil, 5 days/week for 103weeks;• Endpoint:• Remarks:Clinical signs, mortality, body weight gain, foodconsumption, clinical chemistry, haematology or urinaryparameters, organ weight, gross/microscopic abnormalitiesand tumour incidences. Plasma and RBC ChE activitieswere measured in a separate experiment;Mild diarrhoea was reportedly treatment-related but therewere no other adverse clinical signs. No treatment-relatedeffects on bodyweight gain or survival were reported.Cytoplasmic vacuolisation of the liver and adrenal cortexwas observed at increased frequency in low-dose (26%)and high-dose (38%) males compared to controls (14%).Adrenal cortical cytoplasmic vacuolisation was alsoobserved in high-dose males (26% compared to 6% incontrols) and low-dose females (34% compared to 9% incontrols).Non-neoplastic and neoplastic lesions of the pancreas wereobserved in both sexes. The incidence of acinarhyperplasia in treated groups of either sex was notsignificantly different from the controls. When crosssectionaland horizontal sectional data were combined, thetotal incidence of adenomas was significantly higher(p

historical control range (0-28%). Corn oil gavage, itself, isstated to increase the incidence of acinar cell adenomas inmale rats [Note: NTP website - historical control range forpancreatic adenoma in males using corn oil gavage (n=8)as 2-24%; NIH 07 Rat & Mouse Ration].Horizontal sectionsNumbers of Male Rats with Pancreatic Lesions (Chan, 1989; NTP TR342)Vehicle Control 4 mg/kg b.w. 8 mg/kg b.w.Acinar cell hyperplasia 33 44 39Acinar cell adenoma (single) 12 13 7Acinar cell adenoma (multiple) 3 10 10Acinar cell adenoma (total) 15 23 17Cross-sections and horizontalsections (composite)Acinar cell hyperplasia 37 45 39Acinar cell adenoma (single) 16 8 13Acinar cell adenoma (multiple) 9 22* 20*Acinar cell adenoma (total) 25 (50%) a,b 30* (60%) 33* (66%)* P < 0.05 vs. vehicle controls by logistical regression test;a historical control range of adenomas in cross-section from 8 studies at the test facility was 0-22%;bhistorical control range of adenomas in cross-section from 34 NTP studies using corn oil gavage was 0-28%The incidence of mononuclear cell leukaemia (MCL) inmales was significantly increased [11/50 (22%), 20/50(40%), 21/50 (42%) in control, low dose and high dosegroups, respectively]. The incidence of MCL in males inthe present study was within the NTP and facility historicalcontrol ranges (respectively: 2-44%, n= 34 [NTP studies];2-18%, n=8 [facility studies]). The incidence of MCL infemales was 17/50 (34%) in the controls, 21/50 (42%) atthe low dose and 23/50 (46%) at the high-dose [theAPVMA noted that there was no suitable historical controldata to put these data in context][Note: NTP website -historical control range for Leukemia: Lymphocytic,Monocytic, Mononuclear, or Undifferentiated in malesusing corn oil gavage (from 8 separate control groups) as16-44%; in females (from 8 separate control groups) 12-34%; NIH 07 Rat & Mouse Ration].Alveolar/bronchiolar adenomas were observed in 3/50(6%) high dose-males but in no other group. Thisincidence was within the historical control range of 0-8%.The incidence of mammary gland fibroadenomas infemales was significantly but not dose dependentlyincreased; 9/50 (18%) in controls, 19/50 (38%) in lowdoseand 16/50 (32%) in high-dose groups. MultipleDichlorvos reassessment – application Page 196 of 436

fibroadenomas were observed in 6 (12%) of the low doseand 3 (6%) of the high-dose females, and one adenoma(2%) was observed in a high-dose female. Two mammarygland carcinomas were observed in each of the control andlow-dose groups (4%). The incidence of mammarytumours in the present study was within the NTP or facilityhistorical control range [the APVMA reportedrespectively: 12-40%; 16-18%, and concluded thereforenot biologically significant] [Note: NTP website -historical control range for Mammary Gland: Fibroma,Fibroadenoma, Carcinoma, or Adenoma in females usingcorn oil gavage (from 8 separate control groups) as 28-48%; NIH 07 Rat & Mouse Ration].Fibroadenomas (a)Mammary Gland Tumours in Female Rats (Chan, 1989; NTP TR342)Vehicle Control 4 mg/kg b.w. 8 mg/kg b.w.Overall Rates 9/50 (18%) 19/50 (38%) 16/50 (32%)Adjusted Rates (c) 24.5% 62.4% 45.6%Terminal Rates 6/31 (19%) 15/26 (58%) 8/26 (31%)Day of First Observation 547 545 582AdenomaOverall Rates 0/50 (0%) 0/50 (0%) 1/50 (2%)CarcinomaOverall Rates 2/50 (4%) 2/50 (4%) 0/50 (0%)Fibroadenomas, Adenoma, or Carcinoma (b)Overall Rates 11/50 (22%) 20/50 (40%) 17/50 (34%)Adjusted Rates (c) 28.2% 65.8% 48.6%Terminal Rates 6/31 (19%) 16/26 (62%) 9/26 (35%)Day of First Observation 547 545 582Life Table Tests P = 0.049 P = 0.015 P = 0.074Logistical Regression Tests P = 0.072 P = 0.028 P = 0.113(a) Includes multiple fibroadenomas; historical incidence, facility: 113/400 (21-35%); NTP: 436/1700 (19-33%);(b) Historical incidence of benign or malignant mammary gland neoplasms (all types combined), facility:124/400 (23-39%); NTP: 474/1700 (20-36%)(c) Kaplan-Meier estimated tumour incidences at the end of the study after adjusting for intercurrent mortality.Dichlorvos reassessment – application Page 197 of 436

(APVMA, 2008a)• NOAEL < 4 mg/kg b.w./day (lowest dose tested), as plasma ChE was inhibitedin all test groups.The NTP Peer Review concluded that: ―Under the conditions of these 2-yeargavage studies, there was some evidence of carcinogenic activity of dichlorvosfor male F344/N rats, as shown by increased incidences of adenomas of theexocrine pancreas and mononuclear cell leukemia. There was equivocalevidence of carcinogenic activity of dichlorvos for female F344/N rats, asshown by increased incidences of adenomas of the exocrine pancreas andmammary gland fibroadenomas.‖ (Chan PC, 1989)The APVMA review concluded that: ―There was a significant increase inexocrine proliferative lesions of the pancreas in males at 4 and 8 mg/kgbw/d[ay], which were considered to show an equivocal relationship withtreatment. The increased incidences of MCL in males and mammary tumoursin females were not considered biologically significant due to the lack of adose-response relationship and as the incidences fell within the NTP‘srespective historical control range.‖ (APVMA, 2008a)• GLP:• Test Guideline:US FDA;No information;• Reference source: Chan PC (1989) ―Toxicology and carcinogenesis studies ofdichlorvos (CAS No. 62-73-7) in F344/N rats and B6C3F1mice (gavage studies).‖ Performed at Southern ResearchInstitute for the National Toxicology Program, ResearchTriangle Park. Technical Report Series NTP TR No.342.;• Reliability:Klimisch score 2 = reliable with restrictions;KEY STUDY:• Type of study:• Species:• Strain:Mouse oncogenicity study;Mouse;B6C3F1;Dichlorvos reassessment – application Page 198 of 436

• Sex/Numbers:• Test material:• Dose levels:• Endpoint:• Remarks:50/sex/group;Dichlorvos (batch No. SDC 092179; 99% purity);0, 10 or 20 mg/kg bw/day (males) or 0, 20 or 40 mg/kgb.w./day (females) in corn oil, 5 days/week for 103 weeks;Clinical signs, mortality, body weight gain, foodconsumption, clinical chemistry, haematology or urinaryparameters, organ weight, gross/microscopic abnormalitiesand tumour incidences. Plasma and RBC ChE activitieswere measured in a separate experiment;Bodyweight gain was similar in all groups. Survival wasunaffected by treatment.Non-neoplastic lesions occurred with similar frequency inall groups and no effects of treatment on incidences wereobserved.The incidence of forestomach squamous cell papillomaswas elevated at the highest dose in both sexes. This wasstatistically significant on trend analysis in both sexes, butonly in females using a pair-wise comparison between thehigh dose and control groups. These incidence rates wereoutside the available historical control ranges [Note: NTPwebsite - historical control range for Stomach,Forestomach: Squamous Cell Papilloma in males usingcorn oil gavage (from 8 separate control groups) as 0-2%;in females, 0-2%; for Stomach, Forestomach: SquamousCell Carcinoma in females using corn oil gavage (from 8separate control groups) as 0%; NIH 07 Rat & MouseRation]. Forestomach carcinomas were evident in 2females (4%) at 40 mg/kg bw/d but not in any other group,again outside the available historical control range.MaleHyperplasiaForestomach Squamous Lesions in Mice (Chan, 1989; NTP TR342)VehicleControl10 mg/kg b.w. 20 mg/kg b.w. 40 mg/kg b.w.Overall Rates 11/50 (22%) 5/50 (10%) 9/50 (18%)Papilloma (a)Overall Rates 1/50 (2%) 1/50 (2%) 5/50 (10%)Adjusted Rates (c) 2.9% 3.2% 17.2%Terminal Rates 1/35 (3%) 0/27 (0%) 5/29 (17%)Day of First Observation 729 714 729Life Table Tests P = 0.033 P = 0718 P = 0.064Dichlorvos reassessment – application Page 199 of 436

FemaleLogisitic Regression Tests P = 0.032 P = 0753 P = 0.067HyperplasiaOverall Rates 6/49 (12%) 7/49 (14%) 5/50 (10%)PapillomaOverall Rates 5/49 (10%) 6/49 (12%) 18/50 (36%)Adjusted Rates (c) 17.4% 18.1% 44.9%Terminal Rates 3/26 (12%) 4/29 (14%) 13/34 (38%)Day of First Observation 669 442 520Life Table Tests P = 0.006 P = 0.556 P = 0.016Logisitic Regression Tests P = 0.002 P = 0.505 P = 0.004CarcinomaOverall Rates 0/49 (0%) 0/49 (0%) 0/50 (0%)Papilloma or Carcinoma (b)Overall Rates 5/49 (10%) 6/49 (12%) 19/50 (38%)Adjusted Rates (c) 17.4% 18.1% 47.5%Terminal Rates 3/26 (12%) 4/29 (14%) 14/34 (41%)Day of First Observation 669 442 520Life Table Tests P = 0.006 P = 0.556 P = 0.011Logisitic Regression Tests P = 0.002 P = 0.505 P = 0.003(a) Historical incidence of papillomas or carcinomas (combined), facility: 4/396 (0-4%); NTP: 23/1703 (0-3%);(b) Historical incidence of papillomas, facility: 4/396 (0-3%); NTP: 16/1703 (0-3%). No squamous cell carcinomashad been observed in corn oil vehicle control female B6C3F1 mice in NTP studies.(c) Kaplan-Meier estimated tumour incidences at the end of the study after adjusting for intercurrent mortality.(APVMA, 2008a)• NOAEL =• LOAEL =10 mg/kg b.w./day for males and 20 mg/kg b.w./day forfemales;20 mg/kg b.w./day for males and 40 mg/kg b.w./day forfemales, based on forestomach lesions (specificallypapillomas);Dichlorvos reassessment – application Page 200 of 436

The NTP Peer Review concluded that: ―There was some evidence of carcinogenicactivity of dichlorvos for male B6C3F1 mice, as shown by increased incidences offorestomach squamous cell papillomas. There was clear evidence of carcinogenicactivity of dichlorvos for female B6C3F1 mice, as shown by increased incidencesof forestomach squamous cell papillomas.‖ (Chan PC, 1989)The APVMA review concluded that: ―The occurrence of forestomach carcinomasin females at 40 mg/kg bw/d[ay] showed an equivocal relationship with treatment.Mechanistic studies … demonstrate that dichlorvos is irritating to the mouse GIT,as it is to rabbit eyes and skin. Given its irritancy and consistently negative resultsin in vivo genotoxicity studies, the increase in forestomach papillomas seen in thisstudy are concluded to be irrelevant to human dietary risk assessment.‖(APVMA, 2008a) [Note: There is some evidence for genotoxicity at site ofexposure (skin studies) and this supports the possibility of genotoxicity having arole in the forestomach tumours in mice.]• GLP:• Test Guideline:US FDA;No information;• Reference source: Chan PC (1989) ―Toxicology and carcinogenesis studies ofdichlorvos (CAS No. 62-73-7) in F344/N rats and B6C3F1mice (gavage studies).‖ Performed at Southern ResearchInstitute for the National Toxicology Program, ResearchTriangle Park. Technical Report Series NTP TR No.342.;• Reliability:Klimisch score 2 = reliable with restrictions;Justification for Classification:The Chan (1989) studies in rats and mice were carriedout to GLP and NTP guidelines. There is some evidence for carcinogenic activity inboth rats and mice, but at different target organs in each species and sex. Theincreased incidence of adenomas of the exocrine pancreas in male F344/N ratsindicated to the NTP some evidence of carcinogenic activity of dichlorvos, but wasconsidered equivocal by the APVMA, due in part to the lack of a statistical increaseor dose-response in the horizontal sections and issues with the control data (highincidence in concurrent controls; large historic control ranges; corn oil vehicleknown to induce tumour type). The 2-year inhalation study in CFE rats (Blair et al.,1974 & 1976), reviewed by the APVMA and ATSDR revealed no evidence ofcarcinogenicity. However, Chan (1989) also revealed increased incidences offorestomach squamous cell papillomas in male and female B6C3F1 mice. Whileforestomach tumours are not considered directly relevant to humans and the APVMAhave suggested the tumours may be a response to the irritancy of dichlorvos, thesefindings (and the mutagenic potential in certain contact scenarios, see Section 12Mutagenicity) indicate that repeated exposure to high concentrations of dichlorvosposes some carcinogenic hazard. Dichlorvos should be classified as 6.7B, as theevidence meets the criteria in Section 15.2.2 of the User Guide to the Thresholds andClassifications in the HSNO Act (ERMA, 2008). However, TCL notes that therelevance of the exposure scenarios and tumours should be taken into account in anyhuman risk assessment.Dichlorvos reassessment – application Page 201 of 436

BACKGROUND:The ATSDR (1997) summarised the carcinogenic potential of DDVP thus:“In a 2-year carcinogenicity study of inhalation exposure to dichlorvos,groups of 50 Carworth rats of each sex were exposed at levels of 0, 0.05, 0.5,or 5 mg/m 3 (Blair et al. 1976). Only 11 of the unexposed male controls and25 of the unexposed female controls survived to the end of the study.Survival was actually highest in the rats receiving the highest dose ofdichlorvos (32 of 50 males and 34 of 50 females). Microscopic examinationrevealed a wide range of lesions in all groups; the authors stated that theseare commonly seen in old rats of this strain. There was a high incidence in allgroups of chronic nephrosis, focal myocardial fibrosis, degenerative arterydisease, lymphoid hyperplasia of the spleen, and testicular atrophy. Commontumors in all groups were adenomas of the anterior pituitary gland,parafollicular cell adenomas, and carcinomas of the thyroid gland, adrenalpheochromocytomas, and mammary fibroadenomas in the females.Examination of the lungs (presumably the tissue receiving the highest dose)revealed minor changes in all groups. Peribronchial and perivascularlymphoid aggregates, mild degrees of bronchiolitis and focal alveolarthickening were noted. Electron microscopic examination of bronchi,bronchioli, and alveoli of a small number of control and high-dose groupanimals showed no differences between the groups. None of the lesions in thestudy was associated with dichlorvos exposure.“The high mortality of the control animals in this study makes interpretationof the carcinogenicity data problematic. The possibility also exists thatexposure by the oral and dermal routes may have occurred. However, nosignificant increase in neoplastic or non-neoplastic lesions was found in thenasal and respiratory tract tissues that received the highest dose ofdichlorvos.“In a carcinogenicity study in Osborne-Mendel rats, groups of 50 animals ofeach sex were originally dosed through feed at levels of 45 and 90 mg/kg[b.w.]/day (NCI 1977). During the initial 3 weeks of dosage, acute signs oftoxicity were observed including tremor and diarrhea in the 90 mg/kg[b.w.]/day group. For this reason, the dosages were then lowered to 30% ofthe original. The TWA doses over the 80-week period of dosing were 13.5and 29.3 mg/kg [b.w.]/day. After the 80-week dosing period, the animalswere observed for a further 30 weeks until sacrifice. Adverse clinical signs(hematuria, rough coats, epistaxis) were noted in control and dosed animals,gradually increasing during the second year of the study. The authors statedthat at the end of the study the rats were in generally poor condition. Thematched control groups had significantly lower survival than the treatedgroups at the end of the study, mainly due to deaths during the 30-weekobservation period after treatment. At the termination of the study, only 2 of10 male rats and 5 of 10 female rats survived in the matched control groups.For this reason, these control rats were pooled with control rats fromDichlorvos reassessment – application Page 202 of 436

concurrent studies for comparison with the treated groups. Of the male rats,76% of the high-dose and 64% of the low-dose group survived to the end ofthe study as did 84% of the high-dose and 80% of the low-dose females.“Numerous inflammatory, degenerative, and proliferative lesions commonlyseen in aged rats occurred with approximately equal frequency in the treatedand the pooled control rats. Several non-neoplastic lesions occurred morefrequently in the treated rats than in the controls. These included aggregatesof alveolar macrophages in the lungs, interstitial fibrosis of the myocardium,and focal follicular cell hyperplasia of the thyroid gland in the male rats.Benign endocrine neoplasms occurred frequently in both test and controlrats. There was a high incidence of benign mammary neoplasms in bothcontrol and treated rats. Because of the low survival of the matched controlrats, control animals from other concurrent studies were pooled forstatistical analysis. The authors stated that on the basis of variability of boththe incidence and type of spontaneous lesions and the lack of significantproportions of tumors in the dosed groups compared to the controls, nostatistical significance could be attached to the incidence of the tumors seenin the dichlorvos-treated rats in this study. Because of the poor survival ofcontrol animals in this study, the results are difficult to interpret.”“The mechanism of dichlorvos-induced carcinogenicity is not known. A studyof B6C3F1 mouse forestomach from mice treated with dichlorvos by gavagein corn oil (Benford et al., 1994) showed increases in replicative DNAsynthesis (associated with increased cell proliferation). Unscheduled DNAsynthesis (associated with DNA repair) was not increased by dichlorvostreatment, but was increased by 1 -methyl-3-nitro-1 -nitrosoguanidine, aknown genotoxic forestomach carcinogen. The authors concluded that theforestomach tumors seen in the 2-year carcinogenicity study (NTP 1989)may have been mediated by enforced cellular proliferation rather than by agenotoxic mechanism.“Two organizations have reviewed the evidence for dichlorvoscarcinogenicity in humans from the results obtained in test systems. The EPAhas classified dichlorvos as a probable human carcinogen (Category B2) onthe basis of significant increases of forestomach tumors in mice andleukemiasand pancreatic acinar adenomas in rats. Supporting evidenceincluded observation of tumors at other sites in the rat and the observationthat dichlorvos and a major metabolite, dichloroacetaldehyde, are mutagenicin in vitro test systems. A structurally related compound, dichloropropene,also causes forestomach tumors in rodents (IRIS 1995).” (Originals notesighted; ATSDR, 1997)The IARC (1991) summary and evaluation for dichlorvos:“5.1 Exposure data―Dichlorvos has been used widely as an insecticide since 1961 to control internaland external parasites in livestock and domestic animals, to control insects inhouses, and in crop protection.Dichlorvos reassessment – application Page 203 of 436

―Dichlorvos has been formulated for use as dusts, granules, pellets/tablets,impregnated resin strips and concentrates.―Household and public health uses represent the main sources of human exposureto dichlorvos. Exposure may also occur during its production and application.“5.2 Carcinogenicity in humans―One case-control study of leukaemia in the USA found an association with use ofdichlorvos on animals; there were few exposed subjects, and they had potentialexposure to many pesticides.“5.3 Carcinogenicity in experimental animals―Dichlorvos was tested for carcinogenicity by oral administration in twoexperiments in mice and in three experiments in rats. A few rare oesophagealsquamous-cell tumours were found in mice treated with dichlorvos in the diet. Adose-related increase in the incidence of squamous-cell tumours (mainlypapillomas) was noted in the forestomachs of mice that received dichlorvos incorn oil by gavage. In rats that received dichlorvos in water by gavage, a fewsquamous-cell papillomas of the forestomach were seen. In rats that receiveddichlorvos in corn oil by gavage, a dose-related increase in the incidence ofmononuclear-cell leukaemia and an increased incidence of pancreatic acinar-celladenomas were observed in males.“5.4 Other relevant data―A variety of studies in several species did not demonstrate developmentaltoxicity due to dichlorvos.“In vitro, dichlorvos phosphorylates esterases to a greater extent than itmethylates nucleophiles; the likelihood of DNA methylation in vivo is extremelysmall.―Immunosuppression has been noted after short-term administration of high dosesof dichlorvos which are associated with profound cholinergic hyperstimulation.―No data were available on the genetic and related effects of dichlorvos inhumans.―Dichlorvos was not shown to have genetic activity in various assays in mammalsin vivo. It induced gene mutation and chromosomal damage in culturedmammalian cells and in insects, plants, fungi, yeast and bacteria.“5.5 Evaluation―There is inadequate evidence in humans for the carcinogenicity of dichlorvos.―There is sufficient evidence in experimental animals for the carcinogenicity ofdichlorvos.“Overall evaluation―Dichlorvos is possibly carcinogenic to humans (Group 2B).‖Dichlorvos reassessment – application Page 204 of 436

The APVMA (2008a) reported a chronic inhalation study in rats:―Blair D, Dix KM & Hunt PF (1974) Two year inhalation exposure of rats todichlorvos vapour. Report No. TLGR.0026.74. Lab: Tunstall Laboratory, ShellResearch Ltd, Sittingbourne Research Center, UK. Report date: June 1974.―Blair D, Dix KM, Hunt PF, Thorpe E, Stevenson DE & Walker AIT (1976)Dichlorvos - a 2-year inhalation carcinogenesis study in rats. Arch. Toxicol. 35:281-294.―Materials and Methods―Carworth Farm E (CFE) rats (50/sex/group) were exposed individually to airconcentrations of dichlorvos (SNC Pernis, unspecified location; batch No.unspecified; >97% purity) at 0, 0.05, 0.5 or 5 mg/m 3 for 23 h[our]/d[ay] for 2years. Achieved mean concentrations were 0, 0.05, 0.48 and 4.70 mg/m 3 ,respectively. Trimethyl phosphate was also present at 0, 0.007 and 0.04 mg/m 3 inthe low-, mid- and high-dose atmospheres, respectively, as was DCA[dichloroacetaldehyde] at 0.007, 0.013 and 0.028 mg/m 3 . The method ofapplication meant that the rats were exposed dermally, orally (via contaminationof food and water, cage interior and grooming fur), as well as by inhalation.―Rats were housed individually in metal wire cages and fed ad libitum with Diet86 pellets (Charles River, UK). Body weights and feed intake were measuredmonthly and behaviour was monitored daily. Rats dying during the course of thestudy were necropsied where possible. Haematology (Hb, erythrocyte, totalleucocyte and differential leucocyte counts, prothrombin time, and kaolincephalincoagulation time) and clinical chemistry (protein, urea, Na, K, glucoseand Cl concentrations, and plasma AP, AST and ALT activities) were examinedin blood samples collected at necropsy. RBC and plasma ChE activities weremeasured at the same time.―Necropsies were performed on all animals sacrificed at the end of the treatmentperiod. Major organs (brain, heart, liver, spleen and kidneys) were weighed andthese along with additional tissues (anterior pituitary, thyroid, adrenals, mammarygland, pancreas, skin, reticulo-endothelial system, tongue, nasal cavity, trachea,skeletal muscle, and eye and lachrymal gland) were examined microscopically.The left half of each brain was used for examination of ChE activity. Additionalbrain samples were provided to an independent laboratory (B. Holmstedt,Karolinska Intitutet, Stockholm) for assessment of acetylcholine and cholineconcentrations.―Statistical analysis consisted of analysis of variance with Student t-test or χ2 testfor comparison between treated and control groups.―ResultsDichlorvos reassessment – application Page 205 of 436

“Mortalities, Clinical Signs and Effects on Bodyweight and Food Consumption:The average weekly concentrations of dichlorvos in test atmospheres werereasonably consistent and close to nominal throughout the treatment period.Mortality was highest in control groups and lowest in high-dose groups. Survivalrates of 22, 42, 30 and 64% in males, and 50, 60, 58 and 76% in females recordedin control, low-, mid- and high-dose groups, respectively. The highest morbidityrate in controls occurred from approximately 75 weeks. The low survival incontrols caused the early cessation of treatment in males during week 99; femaletreatment continued to week 104.―There were no adverse clinical signs indicative of OP poisoning but some rats,generally males, showed lameness and ulcerated hocks (probably related to thewire floor of the cage). The only lesion noted in treated but not control groups wasa sore tail, often with necrosis of the tip, seen in 2 highdose males and 12 highdosefemales. Body weight gain was slightly though significantly reduced(p

was exposed. The estimated daily ingestion of dichlorvos was 6.2 mg via food,3.6 mg via grooming and less than 0.1 mg via drinking water (percutaneousabsorption was unknown). Thus, the actual daily intake of dichlorvos wasestimated at [sic to] be approximately 10 mg/rat, or 25 mg/kg bw/d[ay] at thehighest dose. The NOEC was 0.05 mg/m 3 (approximately equal to 0.25 mg/kg/bw/d[ay]), based on the inhibition of plasma and RBC ChE activity at 0.5 mg/m 3 .‖(Original not sighted; APVMA, 2008a)The APVMA (2008a) evaluated the carcinogenic risk of DDVP exposure to humansthus:― … oral dosing studies in mice and rats suggest little in the way of a carcinogenicrisk to humans following dietary or drinking water exposure. The occurrence offorestomach tumours in B6C3F1 mice following gavage dosing suggests thatrepeated exposure to high localised concentrations coupled with some irritancypotential are necessary conditions for dichlorvos to be carcinogenic. Importantly,such a scenario is unlikely in humans and the main potential exposure of thegeneral population is by inhaling low concentrations of dichlorvos vapour whenused indoors. The most relevant study in the database for assessing the long-termrisk posed by inhaling dichlorvos vapour was a 2-year rat inhalation studyconducted by Blair et al (1974 & 1976). In this study, no treatment-related effectson the type, distribution or incidence of non-neoplastic or neoplastic lesionsoccurred up to 5 mg/m 3 (achieved concentration of 4.7 mg/m 3 ).―Given the equivocal evidence of carcinogenicity in mice and rats following oraladministration it is worth considering the carcinogenic (and genotoxic potential)of other OPs, such as trichlorfon and naled, which are transformed to dichlorvosin vivo.―Trichlorfon or metrifonate is an OP insecticide, which is converted nonenzymicallyto dichlorvos in water, biological fluids and tissues at pH valuesgreater than 5.5. Trichlorfon has been evaluated by Joint FAO/WHO Meeting onPesticide Residues (JMPR) in 1972, 1976 and 1979, the International Program onChemical Safety (IPCS) in 1992 (Environmental Health Criteria 132) and theJoint WHO/FAO Expert Committee on Food Additives (JECFA) in 2000 (WHOFood Additive Series 45). The International Agency for Research on Cancer(IARC) assessed the carcinogenicity of trichlorfon in 1983 and 1987 classifying itin Group 3 (―The agent is not classifiable as to its carcinogenicity in humans‖).Furthermore, the OCS has evaluated trichlorfon in 1986, 1993, 1994, 1995 and2000. Collectively these evaluations found no evidence of any carcinogenicityfollowing dosing by various routes in rats, mice or hamsters. Trichlorfon hadsome genotoxic potential and was mutagenic in bacteria and mammalian cells,however, there was some variability in the results which was attributed to thepurity of the test material and/or the possible formation of dichlorvos. While themajority of genotoxicity assays were negative, trichorfon was found to inducechromosomal damage at relatively high doses. On the weight-of-evidence it wasconcluded that trichlorfon would be unlikely to pose a genotoxic risk to humans.―Naled is an OP insecticide that converts to dichlorvos in vivo. Naled haspreviously been evaluated by the OCS in 2000 and 2003, with no evidence ofDichlorvos reassessment – application Page 207 of 436

carcinogenicity found in mice following gavage administration. Naled showedevidence of mutagenicity in bacterial but not mammalian in vitro assays.‖(Originals not sighted; APVMA, 2008a)And, the APVMA concluded:―Forestomach tumours were observed in B6C3F1 mice that received dichlorvosby oral gavage. Dichlorvos was considered to have a localised irritant effect onthe mouse forestomach following gavage dosing, leading to hyperplasia andpossible tumour formation. While forestomach tumours are not considereddirectly relevant to humans, and scenarios of high oral exposures are unlikely,these findings indicate that repeated exposure to high concentrations of dichlorvosis undesirable. There is equivocal evidence of carcinogenicity in rats followinglong-term oral dosing. A long-term inhalational study in rats, which simulated themost relevant exposure route in humans, showed no evidence of carcinogenicity.In addition, related compounds that are metabolised to dichlorvos in vivo showedno carcinogenic potential. On the weight-of-evidence, dichlorvos is notconsidered to pose a carcinogenic risk to humans.‖ (APVMA, 2008a)Dichlorvos reassessment – application Page 208 of 436

14 REPRODUCTIVE TOXICITY 6.8HSNO Classification: Reproductive toxicity – NoKEY STUDY:• Type of study:• Species:• Strain:• Sex/Numbers:Rat 2-generation reproductive study;Rat;CD® (SD)BR;30/sex/group;• Test material: Dichlorvos (Lot No. 802097; 98.3%)• Dose levels: 0, 5.0, 20.0, or 80.0 ppm in the drinking water (approx. 0,0.5, 2 and 8 mg/kg b.w./day);• Endpoint:Toxicity and fertility parameters (insemination, fertilityand gestation indices, and gestation period), the number ofpups at birth, the number of still born pups, the ratio ofmale:female pups, litter size, the lactation index and pupbirth weight;• Remarks:F 0 parental ratsMortalities and clinical signs: There was no treatment-related effect onmortality in both sexes and on clinical signs in males. Alopecia (bilateral) ofthe forelimbs increased over time in females at 20 and 80 ppm.Effects on bodyweight: During the premating period there was no treatmentrelatedeffect on bodyweight. Maternal bodyweight gain during gestationwas 9-15% lower at all doses of dichlorvos compared to the control but didnot follow a dose-response relationship.Food and water consumption: Food consumption was comparable across allgroups. At 80 ppm, weekly water consumption (g/kg b.w./day) of males andfemales was lower than the control from prebreeding days 7 to 70,significantly at times. At 80 ppm, maternal water consumption wassignificantly lower than the control during gestation and during lactation butwas not statistically significant. The cause of the lower water consumptionat 80 ppm, due to compound-related toxicity or to the reduced palatability ofthe water, was unclear (note that the previous 2-week palatability studyfound reduced water consumption at 240 and 480 ppm).Dichlorvos reassessment – application Page 209 of 436

ChE activity: There was a significant (p

ppm during premating days, significantly at certain time points. Duringgestation of F 2a litters, maternal water consumption was significantly lower(p

from Charles River Laboratories (CRL) (1996) revealed that the femalefertility indices of 55% (F 2a ) and 50% (F 2b ) were below the averagehistorical control range of 60-100%. In both litters, the pregnancy index waslower at 80 ppm than in the control, suggesting that female fecundity wasreduced with treatment. The number of females with live litters was alsoreduced at 80 ppm (both litters), with an apparent increase in the stillbirthindex in the F 2b litter. The latter was outside of the historical control rangeof 0-10.2% (CRL 1996). Marginal reductions in pup survival (day 7) and thelactation index were noted in both litters but were not considered treatmentrelated.All other reproduction and lactation indices were unremarkable.Offspring (F 2a and F 2b )At 80 ppm, F 2a pup weights (males and females) were 5-15% lower than thecontrols during the entire lactation period [postnatal days 1 (5%), 4 (15%), 7(14%), 14 (12%) and 21 (9%)]. At 80 ppm, F 2b pup weights were also lowerthan the controls during the lactation period, with a greater effect seen inmales than females [at postnatal days 4 (11/14% M/F), 7 (18/7% M/F), 14(16/3% M/F) and 21 (14/2% M/F)]. Although none of the findings in F2pups were statistically significant, the consistent trend at 80 ppm in bothlitters and with the effects seen in F 1 pups means that this effect on pupweight can not be discounted. There were no treatment-related clinical signsobserved in pups during lactation. Macroscopic examination of the 10pups/sex/dose designated for necropsy revealed no treatment relatedabnormalities.• Parental NOAEL =• Parental LOAEL =5 ppm for males and females (~0.5 mg/kg bw/d);20 ppm for male and female rats based on inhibitionof plasma, RBC and brain ChE activities (~2 mg/kgbw/d).• Reproductive NOAEL = 20 ppm (~2 mg/kg bw/d);• Reproductive LOAEL = 80 ppm based on reduced fertility and pregnancyindices, increased stillbirths in the F2 generation, anda reduction in cycling concomitant with an increasein abnormal cycling in F1 maternal rats (~8 mg/kgbw/d).• Offspring NOAEL =• Offspring LOAEL =• GLP: US EPA, 40 CFR Part 160;20 ppm (~2 mg/kg bw/d);80 ppm based on lower pup weights in bothgenerations (~8 mg/kg bw/d).• Test Guideline:US EPA OPPTS 870.3800; OECD;• Reference source: Tyl RW, Myers CB & Marr MC (1992) ―Two-generationreproductive toxicity study of DDVP administered in thedrinking water to CD® (Sprague-Dawley) rats.‖ RTI IDNo. 60C-4629-170. Lab: Reproductive and DevelopmentalToxicology Laboratory, Centre for Life Sciences andDichlorvos reassessment – application Page 212 of 436

Toxicology, Chemistry and Life Sciences, ResearchTriangle Institute, Research Triangle Park, North Carolina,USA. Sponsor: AMVAC Chemical Corporation, LosAngeles, California, USA. Study duration: 9 th January1991 to 23rd June 1992. Report date: 31st August 1992.Tyl RW, Myers CB & Marr MC (1993) ―Addendum tofinal report: Two-generation reproductive toxicity study ofDDVP administered in the drinking water to CD®(Sprague-Dawley) rats.‖ RTI ID No. 60C-4629-170. Lab:Reproductive and Developmental Toxicology Laboratory,Centre for Life Sciences and Toxicology, Chemistry andLife Sciences, Research Triangle Institute, ResearchTriangle Park, North Carolina, USA. Sponsor: AMVACChemical Corporation, Los Angeles, California, USA.Study duration: 9th January 1991 to 23rd June 1992.Addendum date: 5th May 1993. Unpublished. (Originalnot sighted; APVMA, 2008a);• Reliability:Klimisch score 2 = reliable with restrictions;Justification for Classification: Tyl et al. (1992) was carried out to GLP and TestGuideline. Dichlorvos affected reproduction (reduced fertility & pregnancy indices)at maternotoxic doses in rats following administration for two generations via thedrinking water. The NOAEL for reproduction and pup toxicity is above the NOAELfor parental toxicity (respectively: 2 mg/kg b.w./day, 0.5 mg/kg b.w./day), sodichlorvos should not be classified under 6.8 for reproductive toxicity, as theevidence is not strong enough for it to meet the criteria in Section 16.2.2 of the UserGuide to the Thresholds and Classifications in the HSNO Act (ERMA, 2008).Note that the APVMA (2008a) concluded that: ―The NOEL for parental toxicity was5 ppm (~0.5 mg/kg bw/d[ay]) based on the occurrence of toxicologically- andstatistically-significant inhibition of plasma, RBC and brain ChE activities at 20 ppm(~2 mg/kg bw/d[ay]). The NOEL for pup toxicity was 20 ppm (~2 mg/kg bw/d[ay])based on lower pup weights in both generations at 80 ppm (~8 mg/kg bw/d[ay]). TheNOEL for reproductive toxicity was 20 ppm (~2 mg/kg bw/d[ay]) based on reducedfertility and pregnancy indices, increased stillbirths in the F 2 generation, and areduction in cycling concomitant with an increase in abnormal cycling in F 1 maternalrats, at 80 ppm (~8 mg/kg bw/d[ay]).‖BACKGROUND:The ATSDR (1997) reported:“Microscopic examination of male reproductive tissues (prostate, testes,epididymis) and female reproductive tissues (ovaries, uterus) revealed nochanges attributable to oral dichlorvos exposure during 2-year studies inFischer 344/N rats treated at 4 or 8 mg/kg [b.w.]/day for 5 days a week orB6C3F1 mice (males treated at 10 or 20 mg/kg [b.w.]/day, females at 20 or 40mg/kg [b.w.]/day) (NTP 1989). Similar results were obtained in Beagle dogsDichlorvos reassessment – application Page 213 of 436

eceiving dichlorvos by capsule for 52 weeks at up to 3 mg/kg [b.w.]/day(AMVAC Chemical Corp. 1990). Male reproductive tissues examined were thetestes, prostate, and epididymides; female tissues examined were the cervix,ovaries, uterus, and vagina.“In a reproductive toxicity study involving male CF-1 mice, groups of 16 micewere exposed to atmospheres containing dichlorvos at 0, 30, or 55 mg/m 3 for16 hours (0, 3.3, or 6.1 ppm) (Dean and Thorpe 1972). Following dosing, eachmale mouse was caged with 3 randomly selected females for 7 days; thisprocedure was repeated weekly for a total of 8 weeks. Thirteen days after thepresumed mating (which occurred by the middle of the week), the femalemice were sacrificed and the uteri removed for examination. There were nodifferences between control and treated mice in the number of early fetaldeaths, late fetal deaths, or live fetuses found in the pregnant females. Thepercentages of pregnancies for females mated to males exposed to 30 or 55mg/m 3 (3.3 or 6.1 ppm) for 16 hours ranged from 67 to 88% and 63-92%,respectively; for controls, the percentages ranged from 73 to 88%. Underthese exposure conditions, dichlorvos did not appear to affect the fertility ofmale CF-1 mice. [NOAEL = 6.1 ppm, highest concentration tested.]“In another experiment in this study, similar results were obtained for malemice exposed for 4 weeks to atmospheres containing 2.1 or 5.8 mg/m 3 (0.23or 0.64, respectively) dichlorvos for 23 hours a day (Dean and Thorpe 1972).[NOAEL = 0.64 mg/m 3 , highest concentration tested.] (Originals not sighted;ATSDR, 1997)WHO (1993) reported:―Male and female Crl:CD3-1 mice were exposed to dichlorvos concentrations of0, 1.9, 3.0 or 4.6 mg/m 3 , generated from dichlorvos-impregnated PVC strips intheir cages. Exposure began 4 days prior to formation of breeding groups (3females and 1 male) and continued throughout pregnancy. Signs of intoxicationwere not observed. Plasma ChE activity was significantly inhibited (by 90%, 93%and 95% in the 1.9, 3.0 and 4.6 mg/m 3 groups, respectively) when measured onday 4 after beginning of treatment. Gestation length, number of litters, litterfrequency and mean litter size were comparable to controls. No grossly detectablecongenital anomalies were detected in any of the offspring (Casebolt et al., 1990).―A 3-generation, 2-litter/generation reproduction study in rats summarized byWHO (1988) was negative at doses up to 235 ppm in the diet, equivalent to 12mg/kg bw/day (Witherup et al., 1965). [The low dose rate is noted.]―Groups of 14 male NMRI/Han mice received either a single oral dose of 40mg/kg bw dichlorvos in olive oil or 18 daily oral doses of 0 or 10 mg/kg bwdichlorvos in olive oil. On days 9, 18, 27, 36, 54 and 63, two animals from eachgroup were killed and their testes examined histologically. A significant increasein the number of damaged seminiferous tubules (desquamation, decreases in cellpopulation, "holes") was observed in both dichlorvos groups. The supportingSertoli cells were also damaged, which may have resulted in the above effects. InDichlorvos reassessment – application Page 214 of 436

addition, there was an increase in the number and hypertrophy of Leydig cells. Noexplanation was given for these effects (Krause & Homola, 1972, 1974).―An increased incidence, just above background, of sperm abnormalities, wasobserved in a screening study on hybrid mice given five daily i.p. injections of 10mg/kg bw dichlorvos (approximately half the LD 50 ). At lower doses, 1 mg/kg bw,the number of sperm abnormalities was either similar to or lower than those in thecontrols (Wyrobek & Bruce, 1975).―Groups of 16 male juvenile Wistar rats received either 20 mg/kg bw dichlorvosin olive oil on days 4 and 5, 10 mg/kg bw dichlorvos in olive oil daily from days 4to 23, or 0.1 ml olive oil daily from days 4 to 23. On days 6, 12, 18, 26, 34, and50 of life, two rats from each group were sacrificed. Histological examination ofthe testes showed slight reduction in the number of spermatogenic cells andLeydig cells. All changes were reversed by the 50th day of life. It was assumedthat a reduction in testosterone synthesis resulted in damage to the spermatogeniccells (Krause et al., 1976).―In a subsequent experiment measurement of testosterone concentrations in thetestes, and luteinizing hormone (LH) and follicle stimulating hormone (FSH)concentrations in serum showed no differences between treated animals and oliveoiltreated controls (Krause, 1977). However, in this study the use of a differentdosing regimen (10 mg/kg bw by gavage every other day for 2 weeks) prevented astrict comparison with the earlier study by Krause et al. (1976).―Fifty-five male Wistar rats (aged 5 months) were orally administered dichlorvosat levels of 5 or 10 mg/kg bw every other day for 8 weeks. Eleven rats werekilled every 4 weeks. No change was seen in body-weight gain or testes weight.The score values of the seminal cellular system decreased after 4-8 weeks oftreatment, but were restored 8 weeks after the end of treatment (Fujita et al.,1977).‖ (Originals not sighted; WHO, 1993)15 DEVELOPMENTAL TOXICITY 6.8HSNO Classification: Developmental toxicity – NoKEY STUDY:• Type of study:• Species:• Strain:• Sex/Numbers:Rat teratogenicity study;Rat;CD® SD rats;25 females/group;• Test material: Dichlorvos (Lot No. 802097; 96.86%);• Dose levels:0, 0.1, 3.0, or 21.0 mg/kg b.w./day;Dichlorvos reassessment – application Page 215 of 436

• Endpoint:Appearance, behaviour, mortality, food consumption, andbody weight gain of the dams, reproduction parameters,embryotoxicity, foetotoxicity or teratogenicity;• Remarks:Maternal rats: There were no deaths. Cholinergic signs were evident at 21.0mg/kg b.w./day during the dosing period and included tremors, pronepositioning, excitability, leaning/swaying and lower jaw movement.Tremors were reported to occur within 10-60 minutes of dosing. Ratsrecovered following the cessation of dosing. Treatment-related clinical signswere not observed in any other group. The average bodyweight of the 21.0mg/kg b.w./day group was significantly lower (p

• Maternal toxicity NOAEL =• Maternal toxicity LOAEL =3.0 mg/kg b.w./day;21.0 mg/kg b.w./day, based oncholinergic signs, decreased body weightand food consumption.• Developmental toxicity NOAEL = 21.0 mg/kg b.w./day, the highest dosetested;• Developmental toxicity LOAEL was not established.• GLP: US EPA; 40 CFR Part 160;• Test Guideline:• Reference:• Reliability:No information;Tyl RW, Marr MC & Myers CB (1990a) Developmentaltoxicity evaluation of DDVP administered by gavage toCD (Spragues-Dawley) rats. RTI ID No. 60C-4629-10/20.Lab: Reproductive and Developmental ToxicologyLaboratory, Centre for Life Sciences and Toxicology,Chemistry and Life Sciences, Research Triangle Institute,Research Triangle Park, North Carolina, USA. Sponsor:AMVAC Chemical Corporation, Los Angeles, California,USA. Study duration: Unspecified. Report date: 22ndFebruary 1991. Unpublished. (Original not sighted;APVMA, 2008a);Klimisch score 2 = reliable with restrictions;KEY STUDY:• Type of study:• Species:• Strain:• Sex/numbers:Rabbit teratogenicity study;Rabbit;New Zealand White;16 females/group;• Test material: Dichlorvos (Lot No. 802097; 96.86%);• Dose levels:0, 0.1, 2.5, or 7.0 mg/kg b.w./day;Dichlorvos reassessment – application Page 217 of 436

• Endpoint:Appearance, behaviour, mortality, food consumption, andbody weight gain of the dams, reproduction parameters,embryotoxicity, foetotoxicity or teratogenicity;• Remarks:Maternal rabbits: Two and four pregnant rabbits died in the 2.5 and 7.0mg/kg b.w./day groups, respectively. Two females from the 0.1 mg/kgb.w./day group were removed from the study because of early delivery.Treatment-related clinical signs were evident in the 7.0 mg/kg b.w./daygroup during the dosing period (gestation day 7-19) and included ataxia (2-6rabbits), increased respiration (2), subdued behaviour (2), rapid breathing(2-3), salivation (2-3), fine motor tremors (2) and lurching (2). Theseclinical signs were not observed in any other group. Average maternalbodyweight gain was lower than the control at 2.5 and 7.0 mg/kg b.w./dayover gestation day 7-19 (67 and 58%, respectively). When maternalbodyweight was corrected for gravid uterine weight, only the bodyweightgain at 7.0 mg/kg b.w./day appeared to be lower than the control (~54%lower). None of these effects on bodyweight were statistically significant.There was a slight but significant reduction in maternal food consumptionduring the dosing period (gestation day 7-19), which followed a significantlinear trend (p

Research Triangle Park, North Carolina, USA. Sponsor:AMVAC Chemical Corporation, Los Angeles, California,USA. Study duration: 19th June 1990 to 2 nd August 1990.Report date: 22nd February 1991. Unpublished. (Originalnot sighted; APVMA, 2008a);• Reliability:Klimisch score 2 = reliable with restrictions;Justification for Classification: Tyl (1990a and 1990b) were conducted to GLP. Theadverse effects noted appear consistent with significant maternal toxicity, with noevidence of particular developmental sensitivity. Dichlorvos should not be classifiedunder 6.8 for developmental toxicity, as there is no evidence that it meets the criteriain Section 16.2.2 of the User Guide to the Thresholds and Classifications in theHSNO Act (ERMA, 2008).BACKGROUND:The ATSDR (1997) reported:“No adverse developmental effects were observed in CF-1 mice treated bygavage with 60 mg/kg [b.w.]/day dichlorvos during gestation days 6-15(Schwetz et al. 1979). There was no significant effect on implantations, meannumber of fetuses per litter, incidence or distribution of resorptions, or onfetal body measurements. Similar results were observed in New Zealandrabbits treated by gavage with 5 mg/kg [b.w.]/day over gestation days 6-18(Schwetz et al. 1979).“Several animal studies examining developmental toxicity during continuousinhalation exposure to dichlorvos are available. A study in which pregnantmice and rabbits were exposed to dichlorvos only during the organogenesisperiod of gestation showed no significant effect on development (Schwetz etal. 1979). In this study, pregnant CF-1 mice were exposed to 4 mg/m 3 (0.44ppm) dichlorvos for 7 hours a day during gestation days 6-15. At sacrifice onday 18, no significant effects were seen on the mean number of fetuses perlitter, the incidence or distribution of resorptions, or on fetal bodymeasurements. Twenty control litters and 15 litters from treated animalswere examined in this study. [NOAEL = 0.44 ppm].“There was no difference between the litters from controls and dichlorvostreateddams. Pregnant New Zealand rabbits exposed to 4 mg/m 3 (0.44 ppm)for 7 hours a day during gestation days 6-18 also showed no evidence ofdevelopmental toxicity (Schwetz et al. 1979). Mean number of fetuses perlitter, incidence or distribution of resorptions and fetal body measurementswere similar in 14 control litters and 19 treated litters. [NOAEL = 0.44 ppm].“Groups of 15 pregnant Catworth E rats were exposed to atmospherescontaining 0, 0.25, 1.25, or 6.25 mg/m 3 (0, 0.03, 0.14, or 0.69 ppm)throughout their 20-day gestation period (Thorpe et al. 1972). At the end of20 days, the rats were sacrificed and the uteri removed for examination. Thenumber of live fetuses, late fetal deaths, and resorption sites were noted, andDichlorvos reassessment – application Page 219 of 436

live fetuses were weighed and examined for external malformations.Approximately half the fetuses in each litter were processed for alizarinstainedpreparations of the skeleton, and the other half were fixed in Bouin’sfluid and examined for structural abnormalities of the viscera by transversesections. Exposure of dams to all three concentrations of dichlorvos did notaffect the number of fetal resorptions, late fetal deaths, litter size, or meanweight per fetus. One fetus in the litter of dams in the 0.25 mg/m3 group hadskeletal defects and gastroschisis. Because no other fetuses from damsexposed to the same or higher concentrations had these defects, the authorsconcluded that they were not exposure-related. Brain and erythrocyteacetylcholinesterase activities were inhibited 83 and 88%, respectively, indams in the high-exposure (6.25 mg/m 3 ) group, suggesting thatacetylcholinesterase inhibition is not associated with teratogenicity.Measurement of acetylcholinesterase activities in the pups was notperformed. [NOAEL = 0.69 ppm].“In a parallel experiment conducted on groups of 20 pregnant Dutch rabbits(Thorpe et al. 1972), similar results were seen. Dams exposed to dichlorvosat 6.25 mg/m 3 (0.69 ppm), as in the previously described rat study, had highmortality (16 of 20 died). Consequently, the doses used in this experimentwere 0, 0.25, 1.25, 2, and 4 mg/m 3 (0, 0.03, 0.14, 0.22, and 0.44 ppm) over the28-day rabbit gestational period. Six of the 20 rabbits exposed to 4 mg/m3died. In both the 4 and 6.25 mg/m 3 exposure groups, spiking of the exposureconcentration occurred. Sizes of litters, fetal resorptions, and late fetal deathswere unaffected by inhalation exposure to dichlorvos. Mean fetal weightswere significantly depressed (23.1 ± 0.98 g for controls and 20.2 ± 0.98 g forthe 4 mg/m 3 exposure group), but the authors ascribed this to maternaltoxicity. Clinical signs were similar to signs for dams exposed to 6.25 mg/m 3 ;6 dams out of 20 in this group died during the study. Three fetuses fromgroups that had not been exposed to dichlorvos had gastroschisis. Two deadfetuses from one litter in the 4 group had cleft palates, but this may also be aresult of maternal toxicity rather than a developmental effect.” [NOAEL =0.44 ppm]. (Originals not sighted; ATSDR, 1997)The APVMA and WHO also reported on the studies by Schwetz et al. (1979) andThorpe et al. (1972) (Originals not sighted; APVMA, 2008a; WHO, 1988).Dichlorvos reassessment – application Page 220 of 436

16 REPRODUCTIVE OR DEVELOPMENTAL TOXICITY ON OR VIA LACTATION 6.8CHSNO Classification: Reproductive or developmental effects on or vialactation – Insufficient dataKEY STUDY: (see Section 14 Reproductive Toxicity 6.8 above for fuller details)• Type of study:Rat 2-generation reproductive study;• Remarks:Offspring (F 1a litter)There were no treatment-related clinical signs observed in F 1a pups duringlactation.F 1 parental ratsReproductive parameters: Marginal reductions in pup survival (day 7) andthe lactation index were noted in both litters but were not consideredtreatment-related. All other reproduction and lactation indices wereunremarkable.Offspring (F 2a and F 2b )At 80 ppm, F 2a pup weights (males and females) were 5-15% lower than thecontrols during the entire lactation period [postnatal days 1 (5%), 4 (15%), 7(14%), 14 (12%) and 21 (9%)]. At 80 ppm, F 2b pup weights were also lowerthan the controls during the lactation period, with a greater effect seen inmales than females [at postnatal days 4 (11/14% M/F), 7 (18/7% M/F), 14(16/3% M/F) and 21 (14/2% M/F)]. Although none of the findings in F 2pups were statistically significant, the consistent trend at 80 ppm in bothlitters and with the effects seen in F 1 pups means that this effect on pupweight can not be discounted. There were no treatment-related clinical signsobserved in pups during lactation.• Reference source: Tyl RW, Myers CB & Marr MC (1992 & 1993)Unpublished. (Original not sighted; APVMA, 2008a);• Reliability:Klimisch score 2 = reliable with restrictions;Justification for Classification: Tyl et al. (1992) was carried out to GLP and TestGuideline. There is insufficient evidence to show or discount a specific substanceeffect on or via lactation. A two-generation reproductive toxicity study in ratsshowed reductions pup weight during lactation (F 1a , F 2a , F 2b ), suggestive of areduction in lactation or reduced maternal care, but at doses causing frank maternaltoxicity and reduced maternal water intake. Dichlorvos should not be classifiedunder 6.8 for reproductive or developmental toxicity on or via lactation, as theDichlorvos reassessment – application Page 221 of 436

evidence is insufficiently suggestive that it meets the criteria in Section 16.2.2 of theUser Guide to the Thresholds and Classifications in the HSNO Act (ERMA, 2008).BACKGROUND:The potential adverse reproductive or developmental effects on or via lactation bydichlorvos has not been specifically reported by national regulatory agencies.The ATSDR reported:“Because it is rapidly metabolized, dichlorvos has not been detected in blood,adipose tissue, breast milk, or any other tissue samples from the generalpopulation or from populations with occupational exposures.” (Originals notsighted; ATSDR, 1997)Dichlorvos reassessment – application Page 222 of 436

17 SPECIFIC TARGET ORGAN TOXICITY 6.9 (SINGLE DOSE – ORAL)HSNO Classification: Specific target organ toxicity (Single dose – oral) –6.9AKEY STUDY:• Type of study:• Species:• Strain:• Sex/Numbers:Acute Neurotoxicity Study;Rat;SD Crl:CD®BR;12/sex/group;• Test Material: Dichlorvos (Lot No. 802097; 97.87%);• Dose levels:• Endpoint:0, 0.5, 35 or 70 mg/kg b.w. in deionised water (dosevolume was 10 mL/kg b.w.) by gavage;Mortality and clinical signs: pupillary reflex, generalappearance and condition, open field observations(arousal, surface righting reflex and gait, forelimb andhindlimb grasp reflexes); bodyweights; FunctionalObservation Battery (FOB); locomotor activity; necropsy;• Remarks: Mortalities, clinical signs and bodyweight effects: At 70mg/kg b.w., 2 males and 5 females died within 4 h ofdosing. There were no other deaths. Necropsy revealedthat one of the deceased males probably perished due to anintubation error.FOB: The pretreatment FOB was unremarkable. Treatment-related effectson FOB findings were restricted to day 0, while there were no effects at day7 and 14. The majority of abnormal FOB findings at and above 35 mg/kgb.w. were different (higher or lower) than historical control values for age,sex and time-matched rats from the performing laboratory.Home cage observationsAt 70 mg/kg b.w., there was a significant decrease (p

(p

There was a significant dose-related reduction (p

June 1992. Report date: 15th January 1993. Unpublished.(Original not sighted; APVMA, 2008a);• Reliability:Klimisch score 2 = reliable with restrictions;Justification for Classification: Lamb (1993a) was conducted to GLP and TestGuidelines. The LOAEL (35 mg/kg b.w.) for rat is below the threshold for 6.9Aclassification for single dose exposures in Table 17.1 of the User Guide to theThresholds and Classifications in the HSNO Act (ERMA, 2008).BACKGROUND:The ATSDR (1997) reported:“Neurological effects have been seen in many studies in animals after acute oralexposure to dichlorvos. Male Fischer 344 rats exposed to dichlorvos by olive oilgavage during an LD50 study had signs of excessive cholinergic stimulationincluding salivation, tremors, lacrimation, fasciculations, irregular respiration, andprostration (Ikeda et al. 1990). The authors did not report the dose at which thesesigns appeared; the LD50 calculated from the study was 97.5 mg/kg [b.w.]. In 2other studies, in which clinical signs were not reported, single oral doses of 40mg/kg [b.w.] dichlorvos in male rats resulted in a 70% inhibition of brainacetylcholinesterase after one hour (Teichert et al. 1976) and an 83% inhibitionafter 15 minutes (Pachecka et al. 1977).“In greyhound dogs receiving 11 or 22 mg/kg [b.w.] in a single dose, signs ofneurological toxicity appeared within 7-15 minutes of dosing (Snow and Watson1973). Restlessness was seen initially, followed by increased salivation. musclefasciculations, involuntary urination, diarrhea, sometimes bloody, and tenesmus[sic: interpreted as excessive defecation]. There was no apparent difference inseverity of clinical signs between dogs given 11 or 22 mg/kg [b.w.]. Erythrocyteacetylcholinesterase was determined in 11 dogs, and the values ranged from 69 to97% inhibition. The dog with 97% inhibition of erythrocyte acetylcholinesterase(dosed at 11 mg/kg [b.w.]) had severe clinical signs of intoxication but survived.Crossbred pigs receiving single doses from 18 to 560 mg/kg [b.w.] had clinicalsigns of neurological toxicity including hypoactivity, vomiting, ataxia, musclefasciculations, uncoordinated movements, frothy salivation, and defecation(Stanton et al. 1979).” (Originals not sighted; ATSDR, 1997)Dichlorvos reassessment – application Page 226 of 436

18 SPECIFIC TARGET ORGAN TOXICITY 6.9 (SINGLE DOSE – DERMAL)HSNO Classification: Specific target organ toxicity (Single dose – dermal) –6.9BKEY STUDY:• Type of study:• Species:• Strain:• Sex/Numbers:• Test Material:• Dose levels:• Endpoint:Acute Dermal Toxicity (LD 50 ) Study;Rat;RAC;6/sex/group;Dichlorvos (source & purity not given);80-200 mg/kg b.w. to 10 cm 2 area of the shaved skin for24 hours either as concentrate or in PEG (10% v/v);Mortality and clinical signs; necropsy;• Remarks:The LD 50 (males plus females) was 210 mg/kg b.w., with most deathsoccurring after 24 hour.No adverse signs were observed at 80 or 100 mg/kg b.w. (in PEG).At 150 or 200 mg/kg b.w. (concentrate), adverse signs were observed within15-30 minutes of application and included dose-dependent trismus, tonicclonicspasms of limb muscles, prostration, exophthalmus, dyspnoea, andlachrymation and secretion from the Hardersche (Harderian) glands. Symptomspersisted for up to 3 days but surviving animals recovered fully after 5-6 days.Necropsy of animals dying during the observation period revealed acute liver,spleen and kidney congestion, bloated intestines and inflamed peritoneum.Animals sacrificed after 7 days showed enlarged livers, and bloated or slackintestines. No other macroscopic effects were reported.No skin irritation was evident.• NOAEL =• LOAEL =• GLP:100 mg/kg b.w.;150 mg/kg b.w., based on clinical signs of neurotoxicity;No information;Dichlorvos reassessment – application Page 227 of 436

• Test Guideline:No information;• Reference source: Tierfarm, Sissel, Switzerland (1969b) ―Report on thedetermination of the acute dermal LD50 to the rat ofDDVP technical.‖ No study/report No. Lab/Sponsor:unspecified. Unpublished. [Novartis; sub 11605] (Originalnot sighted; APVMA, 2008a);• Reliability:Klimisch score 2 = reliable with restrictions;Justification for Classification: There is no information as to whether or not Tierfarm(1969b) was conducted to Test Guidelines, but it was pre-GLP. The LOAEL (150mg/kg b.w.) for rat is below the threshold for 6.9B classification for single doseexposures in Table 17.1 of the User Guide to the Thresholds and Classifications inthe HSNO Act (ERMA, 2008).Dichlorvos reassessment – application Page 228 of 436

19 SPECIFIC TARGET ORGAN TOXICITY 6.9 (SINGLE DOSE – INHALATION)HSNO Classification: Specific target organ toxicity (Single dose – inhalation)– 6.9AKEY STUDY:• Type of study:• Species:• Strain:• Sex/Numbers:• Test Material:Acute Inhalation Toxicity, LC 50 (4hours, head-only);vapour/aerosol;Rat;Wistar (Bor:WISW);5 (vapour) or 10 (aerosol)/sex/group;Dichlorvos (98.7 % pure, batch no. 809 436 388, lot no.3379);• Dose levels: Vapour: 342 mg/m 3 (nominal), 116 mg/m 3 (analysed) for 4hours;Aerosol: 230-1926 mg/m 3 for 4 hours;• Endpoint: Mortality (LC 50 );• Remarks:For the vapour experiment, 5 animals/sex were exposed for4 hours to a nominal concentration of 342 mg/m 3 (theanalysed concentration was 116 mg/m 3 , the maximumachievable as vapour). All animals showed adverse signsincluding bristling and ungroomed coat, reduced motilityand high gait but there were no deaths. No effects onweight gain were observed during the 14-day observationperiod and autopsy revealed no treatment-related grosseffects.A lethal vapour concentration could not be generated(maximum concentration was 116 mg/m 3 ); LC 50 > 116mg/m 3 (0.116 mg/L).In the aerosol experiment, 10 animals/sex were exposed tonominal air concentrations of 1500 - 15000 μL/m 3 (230-1926 mg/m 3 ) for 4 hours, with the particle mass mediandiameter ranging from 2.8 to 6.4 μm.Adverse signs, evident immediately after exposure (i.e.when rats were removed from tubes) were severe muscletremors and weakness, convulsions, recumbence on side,ataxia, apathy and dyspnoea. More persistent signsincluded ungroomed coat, bristling fur and high gait. AllDichlorvos reassessment – application Page 229 of 436

surviving animals appeared to behave normally during thesecond week of observation.Body weight gain was normal.Animals that died during exposure showed a number ofchanges at autopsy: distended lung; oedematous and pale,patchy liver with lobulation; pale spleen and kidney;hyperaemia of the glandular stomach and serosa of thesmall intestine; and blood and mucus in the gut. Notreatment-related gross effects were observed in thoseanimals surviving the 14-day observation period.• NOAEL =• LOAEL =• GLP:not established;0.23-1.926 mg/L (230-1926 mg/m 3 ), based on clinicalsigns of neurotoxicity [Note: the available summaryimplies adverse effects were noted at all testedconcentrations, but the NOAEL/LOAELs were notstated.];Yes;• Test Guideline: Stated conforming to OECD [403?];• Reference source:• Reliability:Pauluhn J (1984) ―Dichlorvos (L15/20, DDVP) study foracute inhalation toxicity.‖ Report No. 13124;Lab/Sponsor: Bayer AG Institute of Toxicology,Wuppertal-Eberfeld. Report date: 12th December 1984.(Original not sighted.) (APVMA, 2008a);Klimisch score 2 = reliable with restrictions;Justification for Classification: Pauluhn (1984) was conducted to GLP and TestGuidelines. The LOAEL (at 0.23 mg/L) is below the threshold for 6.9Aclassification for single dose exposures in Table 17.1 of the User Guide to theThresholds and Classifications in the HSNO Act (ERMA, 2008).Dichlorvos reassessment – application Page 230 of 436

20 SPECIFIC TARGET ORGAN TOXICITY 6.9 (REPEAT DOSE – ORAL)HSNO Classification: Specific target organ toxicity (Repeat dose – oral) –6.9AKEY STUDY:• Type of study:• Species:• Strain:• Sex/numbers:Dog 2-year dietary study;Dog;Beagle;3/sex/group;• Test material: Dichlorvos; unspecified batch, 93%;• Dose levels: 0, 0.1, 1.0, 10.0, 100 or 500 ppm (equivalent to: 0, 0.0025,0.025, 0.25, 2.5 or 12.5 mg /kg b.w./day); Volatilisationreduced the concentration of dichlorvos present in the feed.Pooled samples taken daily during each week indicatedthat average concentrations were 0.09, 0.32, 3.2, 32.0 and256 ppm at 0.1, 1.0, 10.0, 100 or 500 ppm, respectively.Dichloroacetaldehyde (DCA) was also detected at 0.60,6.4 and 20.0 ppm in the 10.0, 100 or 500 ppm diets,respectively.• Endpoint:Clinical signs, mortality, body weight gain, foodconsumption, clinical chemistry, haematology or urinaryparameters, organ weight, gross/microscopic abnormalitiesand tumour incidences; plasma, RBC and brain AChEactivities;• Remarks:Mortalities, clinical signs and effects on body weight, food consumption,haematology, clinical chemistry and urinalysis: One male dog (500 ppmgroup) was sacrificed in extremis after 68 weeks with a diagnosis ofbronchitis and pneumonia. There were no treatment-related clinical signs,effects on food consumption or on bodyweight. There was no treatmentrelatedeffect on any haematology, clinical chemistry or urinalysisparameter.ChE activity: There was dose-dependent depression of RBC ChE activity indogs, particularly during the earlier periods of treatment. For males this wasevident at 10-100 ppm and in females at 100-500 ppm, with RBC activityreduced 50-90% in both sexes over these concentrations. Plasma ChEfollowed a similar trend but was only depressed in dogs from the 100 and500 ppm groups. ChE activity had returned to pretreatment levels at the endDichlorvos reassessment – application Page 231 of 436

of 2-year treatment period. No effects of treatment were observed on theChE activity in brain cortex or brain stem at necropsy.Necropsy: Absolute and relative liver weights in males of the 100 and 500ppm group and females of the 500 ppm group were marginally higher thanthose of controls. This was reported as of 'borderline significance' but nodetails of statistical methodologies were provided. No other effects on organweight were observed. Pathology revealed a number of spontaneous lesions,with chronic bronchitis, pulmonary granulomas and renal granulomas themost common. These were unrelated to treatment. Rarefaction of thecytoplasm of hepatic cells, with cellular enlargement and thickening of thecell wall, increased in incidence and severity with dose; graded as slight in1/3 females at 10 ppm and 1/3 males and 3/3 females at 100 ppm, and asmoderate in all 500 ppm dogs. There were no architectural changes to theliver. The hepatocellular effects were of such magnitude that liver functionwas not likely to have been affected, and serum liver enzymes revealed nohepatic damage. Two independent pathologists, blind to the experimentalprotocol, were reported to have not seen significant differences inhepatocytes between treated and control animals.• NOAEL =• LOAEL =• GLP:• Test Guideline:0.32 ppm (equivalent to: 0.008 mg/kg b.w./day);3.2 ppm (equivalent to 0.08 mg/kg b.w./day) based oninhibition of RBC ChE activity in males.No;No information;• Reference source: Jolley PW, Stemmer KL & Pfitzer EA (1967) ―The effectsexerted upon beagle dogs during a period of two years bythe introduction of Vapona® insecticide into their dailydiets.‖ Report/Study No. unspecified. Lab: KetteringLaboratory, University of Cincinnati, Ohio, USA. Reportdate: 19th January 1967. Unpublished. (Original notsighted; APVMA, 2008a);• Reliability:Klimisch score 2 = reliable with restrictions (the APVMAconcluded that the study was adequate for assessment);Dichlorvos reassessment – application Page 232 of 436

KEY STUDY:• Type of study:• Species:• Strain:• Sex/numbers:• Test material:• Dose levels:• Endpoint:Dog 52-week capsule study;Dog;Beagle;4/sex/group;Dichlorvos (Lot No. 802097; 100% purity);0, 0.05 (0.1 for the 1 st 3 weeks), 1.0 or 3.0 mg/kg b.w./day;Clinical signs, mortality, body weight gain, foodconsumption, clinical chemistry, haematology or urinaryparameters, organ weight, gross/microscopic abnormalitiesand tumour incidences; plasma, RBC and brain AChEactivities;• Remarks:Mortalities and clinical signs: No dogs died during the study. There was arange of incidental clinical signs observed in both the control and treatmentgroups, but none that were attributable to the test compound. There was aclear treatment-related effect on the occurrence of emesis, which was morepronounced in males than females.Bodyweights and food consumption: There appeared to be a transient effecton bodyweight in highdose males. The mean bodyweight of this groupdropped to below the pretreatment weight by approximately 5% at week 2and then gradually increased to re-establish the pretreatment weight byweek 8. Mean bodyweight then continued to steadily increase, reaching anequivalent bodyweight as the control group by week 20, despite having alower (~7%) pretreatment bodyweight than the control group. None of thesefindings appeared to be statistically significant. An examination ofindividual animal data revealed that the apparent effect on bodyweight inhigh-dose males was attributable to a single animal (#26237) which lostapproximately 15% of its pretreatment bodyweight over the first 3 weeks ofdosing, and never completely recovered. This animal also exhibited thehighest incidence of emesis over the dosing period (29 of the 38 incidents).There was no treatment-related effect on food consumption.Ophthalmoscopy: There were no ophthalmoscopic abnormalities that wereattributable to the test compound.Haematology, clinical chemistry and urinalysis: There was no treatmentrelatedeffect on any haematology, clinical chemistry or urinalysisparameter.Dichlorvos reassessment – application Page 233 of 436

ChE inhibition: There was a clear dose-related inhibition of plasma andRBC ChE activities. Toxicologically-significant inhibition of plasma andRBC (i.e. >20% inhibition relative to pretreatment activity) occurred at andabove 1.0 mg/kg b.w./day at every sampling interval. Statistical analysiswas only performed on data from week 13. The magnitude of inhibition wasequivalent in males and females, ranging from 39-59% and 65-74% forplasma ChE inhibition at 1.0 and 3.0 mg/kg b.w./day, respectively, and 33-65% and 68-94% for RBC ChE inhibition at 1.0 and 3.0 mg/kg b.w./day,respectively. No cholinergic signs were evident at the highest dose evenwith the magnitude of RBC ChE inhibition (up to 94%). Results of brainChE activity measurements were not provided, although it was reported thatstatistical analysis revealed significant inhibition at and above 1.0 mg/kgb.w./day in males (p

BACKGROUND:The APVMA (2008a) also reported:―Witherup S, Stemmer KL & Pfitzer EA (1967) The effects exerted uponrats during a period of two years by the introduction of Vapona® insecticideinto their daily diets. No study or Report No. Lab/Sponsor: The KetteringLaboratory, Department of Environmental Health, College of Medicine,University of Cincinnati, Ohio, USA. Report date: 14th February 1967.―Materials and MethodsDichlorvos (Shell Chemical Co; batch No. unspecified; 93% purity) wasdiluted in ethanol, admixed in the diet (Purine Laboratory Chow) and fed toCD weanling rats (40/sex/group; unspecified strain; Charles River,Massachusetts, USA) at 0, 0.1, 1, 10, 100 or 500 ppm for 2 years(equivalent to 0, 0.005, 0.05, 0.5, 5 and 25 mg/kg bw/d[ay], respectively,using a dietary conversion factor of 20). Diets were prepared weekly.Composite samples collected at 2, 4 and 7 days after preparation were storedfrozen prior to analysis off-site by an unspecified method (Residue analysisLaboratory, Agricultural Research Division, Shell Development Company,Modesto, California, USA). Rats had been acclimatised for two weeks priorto the initiation of treatment and were randomly assigned to each group.Rats were housed 3/cage in a room maintained at 76±2°F.―Rats were observed daily for clinical signs. Bodyweights were recordedweekly for the first year and then twice weekly for the second year. Foodconsumption was not measured. Five rats/sex/group were sacrificed byexsanguination after 6, 12 or 18 months, with all remaining survivorssacrificed at the end of the treatment period (24 months). All rats werenecropsied and examined for gross visceral abnormalities. The followingorgans were weighed: liver, heart, lungs, kidneys, spleen, brain, gonads,pituitary, adrenals, and thyroid. These same organs were histopathologicallyexamined in addition to sections of the CNS.―Blood and urine were sampled from 10 rats/group at 6, 12, 18 and 24months for analysis. The following haematology parameters were analysed:Hb, Hct, total and differential leukocyte count. The following clinicalchemistry parameters were analysed: protein, albumin/globulin (A/G) ratio,and plasma and RBC ChE activities. Plasma and RBC ChE activities werealso measured at regular intervals during the study (13 times). Brain ChEactivity was measured at each of the 4 sacrifice times. The followingurinalysis parameters were analysed: albumin, glucose, acetone, pH andmicroscopic analysis for cellular components, crystals of uric acid, calciumoxide and triphosphates, and for amorphous material.―Results“Dietary analysis: There was considerable loss of dichlorvos associatedwith a gradual increase in DCA [dichloroacetaldehyde]. At the 5 doseDichlorvos reassessment – application Page 235 of 436

levels, analytical dichlorvos concentrations were 0.08, 0.80, 8.0, 80 and 400ppm after 12 h[ours], declining to 0.022, 0.224, 2.24, 22 and 112 ppm after156 h[ours], respectively. Average concentrations of dichlorvos were 0.047,0.467, 4.67, 46.7 and 234 ppm. The average DCA content present was0.014, 0.114, 0.887, 6.86 and 28.6 ppm in these groups, respectively.“Mortalities, clinical signs and bodyweight effects: There was no treatmentrelatedeffect on mortalities, clinical signs or bodyweight gain.“Haematology, clinical chemistry and urinalysis: There was no treatmentrelatedeffect on any heamatology, clinical chemistry or urinary parameter.ChE activity: Plasma and RBC ChE activities were measured 13 timesduring the study, with no significant effects observed in the three lowestdose groups. In the 100 ppm group, plasma and RBC ChE activities werereduced to 60-90% and to 50-90% of controls in males and females,respectively. In the 500 ppm group, activities were reduced to 20-70% and20-60%, respectively. Activities tended to increase as the study progressed.At termination, brain ChE activity was significantly decreased only in the500 ppm group, by 45-47% in rats sacrificed after 6 months, declining to 5-15% in those sacrificed after 24 months.“Pathology: There was no treatment-related effect on organ weights of ratssacrificed at scheduled intervals or at termination, and there were notreatment-related macroscopic lesions. Histology revealed hepatocellularfatty vacuolisation in all 500 ppm rats, and in approximately 80% of femalesand 62% of males at 100 ppm. This was only evident in animals sacrificedafter 18 or 24 months. All neoplastic lesions were benign, with mostoccurring in the mammary and pituitary glands of both sexes without dosedependency.There were no tumours that occurred only at the high-dose.Overall, no treatment-related effects were observed on the incidence ortiming of tumours.“Conclusion: The NOEL following 2-years of dietary exposure todichlorvos was 10 ppm (mean analytical concentration of 4.67 ppm;equivalent to 0.23 mg/kg bw/d[ay]) based on the inhibition of plasma andRBC ChE activity at and above 100 ppm (mean analytical concentration46.7 ppm; equivalent to 2.3 mg/kg bw/d[ay]). Hepatocellular abnormalitieswere evident at 100 and 500 ppm, but these were insufficient to indicateimpairment of normal liver function.‖ (Original not sighted; APVMA,2008a)The ATSDR (1997) reported:“In a 90-day study in female Sherman rats, groups of 10 animals wereexposed to doses ranging from 0 to 69.9 mg/kg [b.w.]/day in their feed(Durham et al. 1957). Two animals from each group were bled on days3, 11, 60, and 90, and serum cholinesterase and erythrocyteacetylcholinesterase were determined. Clinical signs of neurologicaltoxicity were not noted in any dosage group. Cholinesterase data waspresented graphically so the percentage inhibition of theDichlorvos reassessment – application Page 236 of 436

cholinesterases can only be estimated. For serum cholinesterase, dosesof 0.4 and 1.5 mg/kg [b.w.]/day appeared to have no effect. Doses of 3.5and 14.2 mg/kg [b.w.]/day appeared to produce 25-40% inhibition ofenzyme activity compared to control values by the third day of feeding;activity remained depressed up to 60 days, and rose to near controlvalues by the end of the experiment at 90 days. Serum cholinesterase inrats consuming 35.7 and 69.9 mg/kg [b.w.]/day fell by 50% after 3 daysand remained at this level throughout the experiment. Erythrocyteacetylcholinesterase was unaffected at doses up to 3.5 mg/kg[b.w.]/day. Acetylcholinesterase activity was inhibited by 30% after 3days at 14.2 mg/kg [b.w.]/day and remained depressed until the end ofthe experiment. At 35.7 and 69.9 mg/kg [b.w.]/day, erythrocyteacetylcholinesterase was inhibited about 50% after 3 days and 80%after 10 days. There appeared to be some recovery to about 50% ofcontrol by the end of the experiment. Female Fischer 344 rats treatedwith dichlorvos by oral gavage 5 days a week for up to 32 days had nosignificant changes in erythrocyte acetylcholinesterase activity at dosesup to 16 mg/kg [b.w.]/day (NTP 1989). Male rats at the same dosagelevels had a 22% decrease in erythrocyte acetylcholinesterase at day 24at 16 mg/kg [b.w.]/day.” (Originals not sighted; ATSDR, 1997)Dichlorvos reassessment – application Page 237 of 436

21 SPECIFIC TARGET ORGAN TOXICITY 6.9 (REPEAT DOSE – DERMAL)HSNO Classification: Specific target organ toxicity (Repeat dose – dermal) –Insufficient dataKEY STUDY: None• Justification:No studies adequate were reported.BACKGROUND:The ATSDR (1997) reported:“Three cynomolgus monkeys were exposed to dichlorvos dissolved inxylene by daily derrnal doses on a shaved area between the shoulderblades (Durham et al. 1957); cholinergic signs appeared within 10-20minutes of dosage. Signs of toxicity in order of appearance were:nervousness, incoordination, muscle fasciculations, excessive salivation,labored breathing, miosis, and inability to move. The authors stated thatat a given dose, the cholinergic signs tended to become more severewith subsequent doses. Serum cholinesterase and erythrocyteacetylcholinesterase were measured in one monkey that received 75mg/kg [b.w.]/day. After 2 doses, erythrocyte acetylcholinesterase haddeclined about 67%, while serum cholinesterase was unchanged. Whenthese values were measured shortly after the next day’s dosage, theserum cholinesterase had fallen about 33%, while erythrocyteacetylcholinesterase remained inhibited about 67%. The serumcholinesterase recovered after 2 days without dosing, but theerythrocyte acetylcholinesterase did not. After 5 doses, the erythrocyteacetylcholinesterase had fallen by 90% and stayed there until deathoccurred after 12 days, during which 10 doses were administered.”(Originals not sighted; ATSDR, 1997)Dichlorvos reassessment – application Page 238 of 436

22 SPECIFIC TARGET ORGAN TOXICITY 6.9 (REPEAT DOSE – INHALATION)HSNO Classification: Specific target organ toxicity (Repeat dose –inhalation) – 6.9AKEY STUDY:• Type of study:• Species:Chronic (2-year) Inhalation in Rodents;Rat;• Strain: Carworth Farm E;• Sex/Numbers:50/sex/group;• Test material: Dichlorvos (Batch No: unspecified; >97%);• Dose levels: Air concentrations of 0, 0.05, 0.5 or 5 mg/m 3 for 23hours/day for 2 years. Achieved mean concentrations were0, 0.05, 0.48 and 4.70 mg/m 3 , respectively. Trimethylphosphate was also present at 0, 0.007 and 0.04 mg/m 3 inthe low-, mid- and high-dose atmospheres, respectively, aswas dichloroacetaldehyde (DCA) at 0.007, 0.013 and0.028 mg/m 3 ;• Endpoint:Clinical signs, mortality, body weight gain, foodconsumption, clinical chemistry, haematology or urinaryparameters, organ weight, gross/microscopic abnormalitiesand tumour incidences; plasma, RBC and brain AChEactivities;• Remarks:Mortalities, Clinical Signs and Effects on Bodyweight and FoodConsumption: The average weekly concentrations of dichlorvos in testatmospheres were reasonably consistent and close to nominal throughout thetreatment period. Mortality was highest in control groups and lowest inhigh-dose groups. Survival rates of 22, 42, 30 and 64% in males, and 50, 60,58 and 76% in females recorded in control, low-, mid- and high-dosegroups, respectively. The highest morbidity rate in controls occurred fromapproximately 75 weeks. The low survival in controls caused the earlycessation of treatment in males during week 99; female treatment continuedto week 104. There were no adverse clinical signs indicative of OPpoisoning but some rats, generally males, showed lameness and ulceratedhocks (probably related to the wire floor of the cage). The only lesion notedin treated but not control groups was a sore tail, often with necrosis of thetip, seen in 2 highdose males and 12 high-dose females. Body weight gainwas slightly though significantly reduced (p

odyweight depressed by 10-13% (only significant in males). Foodconsumption was unaffected by treatment.Clinical chemistry: At termination there was a slight though significantincrease (p

Ltd, Sittingbourne Research Center, UK. Report date: June1974.Blair D, Dix KM, Hunt PF, Thorpe E, Stevenson DE &Walker AIT (1976) ―Dichlorvos - a 2-year inhalationcarcinogenesis study in rats.‖ Arch. Toxicol. 35: 281-294.(Original not sighted; APVMA, 2008a);• Reliability:Klimisch score 2 = reliable with restrictions;Justification for Classification: Blair et al. (1974 & 1976) were not conducted to GLPor Test Guideline. The LOAEL (= 0.5 mg/m 3 ) is below the threshold for 6.9Aclassification as a mist for repeat dose exposures in Table 17.2 of the User Guide tothe Thresholds and Classifications in the HSNO Act (ERMA, 2008). [0.5 mg/m 3 isconverted to 0.0005 mg/L, so is well below the threshold of 0.5 mg/L for 6.9A as amist.]BACKGROUND:The ATSDR (1997) reported:“Hematological Effects. Hematological parameters (hemoglobinconcentration, erythrocyte numbers, total and differential leucocytenumbers, prothrombin time, and kaolin-cephalin coagulation time) for ratsexposed to atmospheres containing up to 5 mg dichlorvos/m 3 (0.6 ppm) for2 years were not significantly different from controls (Blair et al. 1976).“Hepatic Effects. Increased serum levels of serum glutamic oxaloacetictransaminase (SGOT, now identified as aspartate aminotransferase [AST])and serum glutamic pyruvic transaminase (SGPT, now identified as alanineaminotransferase [ALT]), possibly indicating hepatic damage, wereobserved in male Carworth E rats exposed to 5 mg dichlorvos/m 3 (0.6 ppm)in a 2-year inhalation study (Blair et al. 1976). No changes in SGOT orSGPT were reported in rats of either sex exposed to 0.06 ppm dichlorvos.“Body Weight Effects. The body weight of male Cat-worth E rats exposedto atmospheres containing 5 mg dichlorvos/m 3 (0.6 ppm) for 2 years wasconsistently 20% or more below the body weight of control rats from thetenth week of treatment (Blair et al. 1976). Body weights of female ratsexposed under the same conditions were not significantly different fromcontrols.“Metabolic Effects. Decreased serum chloride was reported in maleCarworth E rats exposed to 5 mg/m 3 dichlorvos (0.6 ppm) in a 2-yearinhalation study (Blair et al. 1976). The magnitude of this decrease was notreported. No changes in serum chloride were reported in rats of either sexexposed to 0.06 ppm dichlorvos.Immunological and Lymphoreticular EffectsDichlorvos reassessment – application Page 241 of 436

― … Total and differential leucocyte numbers were unchanged compared tocontrols in Carworth E rats exposed to atmospheres containing up to 5mg/m 3 (0.6 ppm) for 2 years (Blair et al. 1976).Neurological Effects“Several studies in animals have addressed neurological effects afterintermediate-duration inhalation exposure to dichlorvos. In a study ofpregnant Carworth E rats exposed over their gestation period (20days), some dams exposed to atmospheres containing 6.25 mg/m 3(0.69 ppm) were less active than controls (Thorpe et al. 1972).Exposure at 0.25 mg/m 3 (0.03 ppm) did not affect erythrocyte or brainacetylcholinesterase. Exposure at 1.25 mg/m 3 (0.14 ppm) resulted in a29% inhibition of erythrocyte and a 28% inhibition of brainacetylcholinesterase, while exposure at 6.25 mg/m 3 resulted in 88%inhibition of erythrocyte acetylcholinesterase and an 83% inhibition ofbrain acetylcholinesterase. In the same exposure atmosphere, pregnantDutch rabbits showed inhibition of 14 and 10% in erythrocyte andbrain acetylcholinesterase, respectively, at an exposure of 0.25 mg/m 3(0.03 ppm) over a period of 28 days (Thorpe et al. 1972). At exposuresof 1.25 mg/m 3 (0.14 ppm) erythrocyte acetylcholinesterase wasinhibited 68% and brain acetylcholinesterase was inhibited 56%compared to controls. Exposure of Yorkshire pigs for 24 days toatmospheres containing 0.09-0.11 mg/m3 (0.010-0.012 ppm) had noeffect on serum cholinesterase or erythrocyte acetylcholinesterase(Loeffler et al. 1976).” (Originals not sighted; ATSDR, 1997)Dichlorvos reassessment – application Page 242 of 436

23 OTHER POTENTIAL TOXIC ENDPOINTS23.1 Endocrine Disruption:The APVMA (2008a), ATSDR (1997), US EPA (2006) and WHO (1988 & 1993)reviews did not address endocrine disruption directly. However, the reportedreproductive and development studies gave no indication of specific endocrinedisruptive effects. The toxicology profile of dichlorvos was dominated by neurotoxiceffects.The ATSDR 1997) reported:“Cytoplasmic vacuolization of adrenal cortical cells was noted in maleFischer 344 rats receiving 4 or 8 mg/kg [b.w.]/day dichlorvos by gavagefor 5 days a week for 2 years (NTP 1989). The authors stated that thesechanges were minor in extent but have been associated with lipidaccumulation in cells. Significant neoplastic lesions of the pancreas(adenomas) were also observed in the male rats. No increase in lesionswas observed for male or female rats in the parathyroid, pituitary,thyroid or thymus glands. No treatment-related lesions were observedfor any endocrine tissue in B6C3FI mice treated for 2 years at 20 mg/kg[b.w.]/day (males) or 40 mg/kg [b.w.]/day (females) (NTP 1989) or inBeagle dogs (groups of 4 of each sex) receiving up to 3 mg/kg/day bycapsule for 52 weeks (AMVAC Chemical Corp. 1990).” (Originals notsighted; ATSDR, 1997)US EPA Endocrine Disruptor Screening Program (EDSP)The US EPA has published the final list of the first group of pesticide active ingredientsand High Production Volume (HPV) chemicals for testing for hormonal effects (FederalRegister / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices). The selection of thechemicals was based on exposure potential (greater potential for exposure, greaterlikelihood for inclusion in the first list). The US EPA noted that ―it [the first selection]should not be construed as a list of known or likely endocrine disruptors‖. In relation todichlorvos, it has been removed from the list of substances to be reviewed with thefollowing conclusion:―The initial analysis using the exposure based criteria for chemical selectionfound dichlorvos in three exposure pathways: Food, residential, and occupational.There are currently no registered uses of dichlorvos that will result in occupationalexposure pathways associated with the selected 14 work activities/crop categorieshaving the highest transfer coefficients. Dichlorvos is only present in twoexposure pathways (food and residential) and will not be tested at this time.‖Source: http://www.epa.gov/endo/pubs/final_list_frn_041509.pdfThe exclusion of dichlorvos by the US EPA from the first list of chemicals for screeningunder the EDSP gives no guidance on the inherent potential of dichlorvos to causehormonal effects, as the exclusion was solely based on exposure potential.23.2 Neurotoxicity:Dichlorvos reassessment – application Page 243 of 436

[See earlier Sections for Key Studies with neurotoxicological end-points.]Dichlorvos exerts toxicity by inhibition of plasma, RBC and brain ChE activities, as themost sensitive end-points, and as a result is neurotoxic. However, studies indicate thatdichlorvos does not induce organophosphate-induced delayed neurotoxicity (OPIDN) inhen or rat.The APVMA (2008a) reported:―Dose-related inhibition of plasma, RBC and brain ChE activities was themost common manifestation of dichlorvos toxicity in short-term, subchronicand chronic studies in mice, rats and dogs. Cholinergic signs and occasionalmortalities occurred in rats and dogs at the same doses as the inhibition ofbrain ChE activity. Plasma and RBC ChE activities were also inhibitedfollowing chronic inhalational exposure in rats (LOEC = 0.5 mg/m 3 ; Blair etal 1974 & 1976).―Dichlorvos is acutely neurotoxic in chickens and rats by virtue of its abilityto inhibit brain ChE activity (Beavers 1988; Lamb 1993a). This is typifiedby the occurrence of cholinergic signs and abnormal FOB (rats) followingsingle or repeated oral dosing. There was no evidence that dichlorvos causesdelayed neuropathy (Beavers 1988; Redgrave et al 1994a & b, Redgrave &Mansell 1994, Jortner 1994 and Hardisty 1998; Lamb 1993b).‖ (Originalsnot sighted; APVMA, 2008a)[See Section 17: Specific target organ toxicity (Single dose – oral) for Lamb (1993a &1993b).]―Beavers J, Driscoll CP, Dukes V & Jaber M (1988) DDVP: An acutedelayed neurotoxic study in chickens. Wildlife International Ltd Project No.246-103. Lab: Wildlife International Ltd, Easton, Maryland, USA. Sponsor:AMVAC Chemical Corporation, Los Angeles, California, USA. Studyduration: 8th August 1988 to 20th September 1988. Report date: 29thDecember 1988.―GLP compliant (US EPA; 40 CFR Part 160) and QA study. Study based inpart on Section 81-7 of US EPA/OPP Pesticide Guidelines (Subdivision F,EPA 540/9-82-025, November 1982).“Materials and MethodsA single oral gavage dose of dichlorvos (AMVAC Chemical Corporation,Los Angeles, CA, USA; lot No. 802097; 96.5% purity) was administered to10 fasted domestic chickens/group (42 weeks old; 1214-1688 g bw; TruslowFarms Inc, Chestertown, Maryland, USA) at 0 or 16.5 mg/kg bw in distilledwater. A positive control group was administered a single oral gavage doseof 600 mg/kg bw tri-ortho cresyl phosphate (TOCP) in corn oil. After 21days, all positive control birds were sacrificed, while the negative controland dichlorvos groups were redosed (after a minimum of 15 hours fasting)and observed for a further 21 days.Dichlorvos reassessment – application Page 244 of 436

―Results“Mortalities and clinical signs: There were no mortalities in any group.Dichlorvos-treated birds exhibited cholinergic signs (lethargy or depression,incoordination, lower limb weakness, wing droop, reduced reaction toexternal stimuli, a ruffled appearance, prostrate posture and a loss ofrighting reflex) from approximately 30 min after dosing. Birds thenrecovered over the 21-day observation period. Following the second dose (atday 22), similar clinical signs were observed. Two TOCP-treated birdsexhibited transient incoordination or lower limb weakness at day 0, with athird bird exhibiting the same clinical signs over an extended period of time.By terminal sacrifice on day 21, all TOCP-treated birds exhibitedincoordination and lower limb weakness.“Locomotor activity: One animal from the control group (#1768) showedlocomotor abnormalities at days 7 (incoordination, pronounced ataxia) and10 (incoordination). Two separate birds refused to hop or walk at day 25,but were not ataxic. Three birds from the dichlorvos group showedlocomotor abnormalities over the first 10 days of dosing; at day 3 (#G30,G37; slight to moderate ataxia), 7 (#G37; slight ataxia) and 10 (#G36; slightlameness). Two birds from the TOCP group (#R254, R255) showedlocomotor abnormalities (slight-moderate ataxia) on day 3 and 7,respectively. However, the most obvious effect on this group occurred atday 21 when 6/10 birds exhibited abnormal locomotory activity rangingfrom slight to pronounced ataxia. This finding was clearly treatment-relatedand indicated that the positive control did in fact cause delayedneurotoxicity.“Histopathology: No control birds displayed any microscopic abnormalitiesof the brain, spinal cord or bilateral peripheral nerve, while one bird treatedwith dichlorvos (#G37) exhibited sciatic neural degenerative changes(described as swelling of the axis cylinder and nerve fibre degeneration). Incontrast, treatment with the positive control (TOCP) resulted in 5/10 birdswith degeneration of the sciatic nerve, particularly the distal segments. Thedegeneration included swelling of the axis cylinder, nerve fibredegeneration and Schwann cell proliferation. It is somewhat difficult todismiss the sciatic nerve degeneration in the single bird in the dichlorvosgroup since the finding was qualitatively the same as the positive controland no such findings occurred in the negative controls. An examination ofindividual bird data for the positive control group did not reveal a strongcorrelation between abnormal locomotor activity and sciatic nervedegeneration. In fact, 2/5 birds that exhibited nerve degeneration showed nolocomotor effects, while 3/5 birds that showed no degeneration displayedabnormal locomotor activity. In the absence of historical control data, theoccurrence of neural degenerative changes in the single dichlorvos-treatedhen was considered by the reviewing toxicologist to be of equivocalrelationship to treatment.Dichlorvos reassessment – application Page 245 of 436

“Conclusions: A single oral dose of 16.5 mg/kg bw dichlorvos resulted incholinergic signs and significantly reduced food consumption.Histopathological examination revealed sciatic nerve degeneration in onehen in the absence of any clinical signs of delayed neurotoxicity. It wasequivocal whether this finding was attributable to dichlorvos treatment.Deficiencies noted in this study were the absence of statistical analysis andmacroscopic examination. Furthermore, no biochemical analysis wasperformed on any birds, such as the measurement of neuropathy targetesterase (NTE) or brain ChE activity.‖ (Originals not sighted; APVMA,2008a)―Redgrave VA, Mansell P, Crook D, Begg, SE, Gopinath C, Anderson A &Dawe IS (1994a) DDVP: 28-day neurotoxicity study in the domestic hen.Study No. AVC 1/921405. Lab: Huntingdon Research Centre Ltd,Huntingdon, Cambridgeshire, England. Sponsor: AMVAC ChemicalCorporation, Los Angeles, California, USA. Study duration: 28th April1992 to 3rd February 1994. Report date: 21 st October 1994.―Redgrave VA & Mansell P (1994) TOCP: Supplementary data on thedelayed neurotoxicity to the domestic hen. Study No. AVC 1a/931884.Sponsor: Huntingdon Research Centre Ltd, Huntingdon, Cambridgeshire,England. Sponsor: AMVAC Chemical Corporation, Los Angeles,California, USA. Study duration: 14th April 1993 to 22nd July 1994. Reportdate: 17th February 1994.―Redgrave VA, Cameron DM, Gopinath C & Dawe IS (1994b) TOCP: 28-day neurotoxicity in the domestic hen. Study No. RAD 2/942053. Sponsor:Huntingdon Research Centre Ltd, Huntingdon, Cambridgeshire, England.Sponsor: AMVAC Chemical Corporation, Los Angeles, California, USA.Study duration: 16th November 1993 to 4th February 1994. Report date:21st October 1994.―Jortner B (1994) Neuropathological review of studies AVC/1 and RAD/2,Huntingdom Research Centre. Report No. unspecified. Sponsor: AMVACChemical Corporation, Los Angeles, California, USA. Report date:September 1994.―Hardisty JF (1998) Pathology working group peer review of DDVP 28-dayneurotoxicity study in the domestic hen. EPL Project No. 578-001. Lab:Experimental Pathology Laboratories Inc, Research Triangle Park, NC,USA. Sponsor: AMVAC Chemical Corporation, Los Angeles, California,USA. Report date: 2nd April 1998.―GLP compliant (UK Compliance Programme, Dept Health & SocialSecurity 1986 and subsequent revision, Dept Health 1989; EC CouncilDirective 87/18 EEC of 19 December 1986, No. L 15/29; GLP in the testingof Chemicals OECD, ISBN 92-64-12367-9, Paris 1982, subsequentlyrepublished OECD Environment Monograph No. 45, 1992; US EPA; 40CFR Part 160; Japanese Ministry of Agriculture, Forestry and Fisheries, 59NohSan, Notification No. 3850, Agricultural Product Bureau, 10th AugustDichlorvos reassessment – application Page 246 of 436

1984). QA study. Study conducted according to US EPA PesticideAssessment Guidelines, Subdivision F, Hazard Evaluation: Human andDomestic Animals, Addendum 10: Neurotoxicity Series 81, 82 and 83,dated March 1991.―Materials and Methods―Dichlorvos (AMVAC Chemical Corporation, Los Angeles, CA, USA; lotNo. 802097; 97.87% purity) was administered orally by gavage to 12 adultfemale domestic hens per group (approximately 12-months old; 1945-2295g bw; Atkinson Bros, Postland, Crowland, Peterborough, Cambridgeshire,England) at 0, 0.3, 1.0 or 3.0 mg/kg bw/d[ay] in distilled water for 28 days.An additional group of 3 birds was administered 0.1 mg/kg bw/d[ay]dichlorvos for measurement of brain ChE activity. A positive control groupwas administered a daily oral gavage dose of 7.5 mg/kg bw/d[ay] TOCP(Coalite Chemical Group, location unspecified; Batch No. S16848; assumed100% purity) in corn oil for 28 days.―Results“Mortalities, clinical signs: One bird from the 1.0 mg/kg bw/d[ay] groupand 4 birds from the 3.0 mg/kg bw/d[ay] group died during or immediatelyafter the 28-day dosing period. Pretreatment mortalities in other groups(including the control) were due to aggression. Treatment-related clinicalsigns were observed at 1.0 and 3.0 mg/kg bw/d[ay] dichlorvos, but did notoccur in any other groups (including the positive control). At 1.0 mg/kgbw/d[ay], only 2/21 birds exhibited clinical signs, which included aninability to stand and unsteadiness. At 3.0 mg/kg bw/d[ay], 19/21 birds werequiet or subdued and unsteady. These clinical signs were observed 30 minafter dosing and were reported to last for up to 8 hours. By day 30, allsurviving birds appeared normal.“Delayed locomotor ataxia: It was reported that there were no clinical signsof neurotoxicity and no evidence of delayed locomotor ataxia in any bird.However, the results of the assessment of ataxia were not provided,including results for the positive control.“Brain ChE activity: There was dose-related inhibition of brain ChEactivity, which was toxicologically significant (ie. >20% relative to thecontrol) at and above 1.0 mg/kg bw/d[ay] at day 4, and at and above 0.3mg/kg bw/d at day 30. No statistical analysis was performed on this data.“NTE activity: There was no treatment-related effect on either brain orspinal cord NTE activity. [Neuropathy target esterase (NTE); Inhibition ofthis particular enzyme is a marker for predicting delayed neurotoxicity fromorganophosphate pesticides. (Handbook of Pesticide Toxicology, Ed RKrieger, 2001, Academic Press, San Diego CA. USA, Vol 2 p953ff.)] Incontrast, the positive control (7.5 mg/kg bw/d[ay] TOCP) caused a markedreduction in both brain and spinal cord NTE activity relative to the negativecontrol at day 4 and 30. No statistical analysis was performed on this data.Dichlorvos reassessment – application Page 247 of 436

“Necropsy: Macroscopic examination of deceased hens and those sacrificedat days 49 and 77 revealed no abnormalities that could be attributed todichlorvos.“Histopathology: At days 49 and 77, TOCP-treated birds (5/6) showedaxonal degeneration in the cerebellum ranging from a trace to minimal,while there were no treatment-related abnormalities in the cerebellum of anyother group. Relative to the negative control, there was an increasedincidence of axonal degeneration in the lower cervical and lumbo-sacralspinal cord of dichlorvos-treated birds, but this did not follow a doseresponserelationship and was generally graded as ―trace‖. According to thegrading system used by the study authors, a grading of ―trace‖ is notconsidered as biologically significant. Therefore, the majority of thesefindings can be disregarded as treatment-related. However, it should benoted that 1/6 and 2/6 dichlorvos-treated birds sacrificed at day 49 werescored as having minimal axonal degeneration in the upper cervical spinalcord, respectively, compared to 0/6 in the negative control group. Singlebirds in these groups were also graded as having minimal axonaldegeneration in the upper cervical spinal cord at day 77, and in the lowercervical region at days 49 and/or 77. While these incidences are slightlyhigher than the performing laboratories historical control range of 0-10%,the reviewing toxicologist did not consider that they were treatment-related.―Neuropathological findings from the current study, as well as those from asupplementary study (No. RAD 2/942053, see below), were reviewed byJortner (1994) at the request of AMVAC. This review involved a reevaluationof the histopathology slides for each animal. There was nodifference in the types and severity of lesions in the spinal cord of negativecontrol and dichlorvos-treated birds across all dose levels. In contrast, birdstreated with 15 or 20 mg/kg bw/d[ay] TOCP (Study No. RAD 2/942053)exhibited moderate to marked fibre degeneration in the spinal cord. Jortnerconcluded that dichlorvos does not cause OP-induced delayed neuropathy(OPIDN). Histopathology slides were re-examined again in 1998 by apathology working group convened by the sponsor (EPL Project N578-001).This working group confirmed the previous findings and conclusions.“Conclusions: The NOEL in hens following 28-days of repeated oral dosingwas 0.1 mg/kg bw/d[ay], based on the occurrence of toxicologicallysignificantinhibition of brain ChE activity at and above 0.3 mg/kgbw/d[ay]. Cholinergic signs occurred at and above 1.0 mg/kg bw/d[ay].There was no evidence that dichlorvos caused delayed neurotoxicity. Theabsence of statistical analysis and results of the locomotor assessment weredeficiencies of this study.‖ (Originals not sighted; APVMA, 2008a)23.3 Immunotoxicity:The ATSDR (1997) reported:Dichlorvos reassessment – application Page 248 of 436

“No information was located on immunotoxicity in humans afterdichlorvos exposure. Only a few studies were located that addressedimmunotoxicity in animals after dichlorvos exposure.Immunosuppression after oral exposure to dichlorvos in rabbits hasbeen reported in three studies (Casale et al. 1983; Desi et al. 1978,1980). A dose-related suppression of the humoral immune responseinduced by S. typhimurium was observed in rabbits (Desi et al. 1978).A single oral dose of 120 mg/kg [b.w.] dichlorvos in male C57B l/6 micethat had been inoculated with sheep erythrocytes 2 days earliersuppressed the primary IgM response observed 48 hours later (Casaleet al. 1983). Severe signs of dichlorvos neurotoxicity were noted, andthe authors stated that the immunosuppression observed in this studymay have been mediated indirectly by toxic chemical stress. It isunknown if the immune suppression noted after dichlorvos exposure inthese studies is secondary to cholinergic stimulation. Immunotoxicitystudies employing atropine prophylaxis to counteract theanticholinesterase effect of dichlorvos are necessary to resolve thisquestion. Additional studies examining potential longer-term effects ofdichlorvos on the immune system by all three routes as well as shorttermeffects by the inhalation and dermal routes would be importantfor estimating human susceptibility for populations exposed for varyinglengths of time at hazardous waste sites.” (Originals not sighted;ATSDR, 1997)WHO (1988) also reviewed Desi et al. 1978, 1980.Dichlorvos reassessment – application Page 249 of 436

24 HUMAN EXPOSURE REPORTSThe APVMA (2008b) reported:―Hayes (1982) has described several cases of accidental occupationalpoisoning with dichlorvos. Two workers died after splashing a concentratedformulation on their bare arms and failing to wash it off promptly. In aserious but non-fatal case following dermal exposure, the victim developedslurred speech and drowsiness slightly more than 1.5 hours after theaccident. He collapsed suddenly after reaching a hospital but was saved byadministration of oxygen, artificial respiration, 15 mg atropine sulfate(mostly iv) and other supportive treatment. Spillage of a 3% dichlorvossolution in oil onto a man‘s lap resulted in severe poisoning. There was noeffort to remove the poison for about 30 minutes after the accident, when asuperficial wash was performed, followed by a bath at 90 minutespostexposure. The estimated dose of dichlorvos in this incident was 72mg/kg bw. In another case, a man spilled a smaller amount of the sameproduct onto his arm. He removed his shirt immediately and washed withsoap and water about 15 minutes later, but developed dizziness and nausea.“Bisby JA & Simpson GR (1975) An unusual presentation of systemicorganophosphate poisoning. Med J Australia 2; 394 – 395.A PCO was accidentally exposed to dichlorvos (1% solution in mineralspirit) whilst using a gasoline engine-powered knapsack mister. He wasfumigating a commercial premises and was wearing a singlet and overallsand a cartridge-type respirator. After 10 minutes he noticed a leak onto hisleft shoulder from a faulty seal and changed his overalls, but notundergarments, and placed a plastic sheet under the sprayer. During the day,he noticed increasing local irritation and burning in the contaminated skinarea. By the end of the shift he reported excessive tiredness, weakness,dizziness and breathing difficulties. After showering, the symptomsimproved although rapid shallow breathing lasted for 2 hours. He developedskin irritation, consisting of extensive areas of erythema and bulla. Whenwhole blood ChE was measured 3 days after exposure, it was 36% ofnormal but reached 51% after 5 days and 78% after a month.“Mathias CGT (1983) Persistent contact dermatitis from the insecticidedichlorvos. Contact Dermatitis 9; 217 – 218.A truck driver was exposed dermally to a liquid product containing 5%dichlorvos in 15% petroleum distillate and 80% trichloroethane, whichbecame spilled in vehicle. The next day he awoke with dermatitis of hisneck, anterior chest, dorsal hands and forearms. He also experienced afrontal headache, mild rhinorrhea, burning of the tongue and a bitter taste inhis mouth. Initial blood ChE activity level was in the ―low normal range‖. Arepeat assay 2 weeks later revealed activity in the ―high normal range‖. Thedermatitis resolved approximately 10 weeks after onset. Patch tests withdichlorvos in petrolatum were negative, so the cause of irritation waspresumed to be irritation rather than sensitisation.Dichlorvos reassessment – application Page 250 of 436

“Comment: These incidents clearly illustrate the potential for dichlorvos tocause toxicity via the dermal route. Dermal absorption may have beenenhanced by the mineral spirits/organic solvents in which the dichlorvoswas diluted. Given that dichlorvos is a slight skin irritant and was present atonly 1 or 5%, the dermal reactions were probably caused by the solvents.‖(Originals not sighted; APVMA, 2008b)The APVMA (2008a) also reported:In ATSDR (1997):―Gold RE & Holcslaw (1984) Dermal and respiratory exposure ofapplicators and residents to dichlorvos-treated residences. In: Dermalexposure related to pesticide use: discussion of risk assessment (RCHoneycutt, G Zwerg & N Ragsdoleet eds). American chemical SocietySymposum Series No. 273.―Materials and Methods―Two applicators were monitored for their exposure to dichlorvos during thetreatment of twenty singlefamily residences with a 0.5% water-emulsionspray prepared from Vaponite 2EC (unspecified source and batch/lot No.;24.7%). The application rate was 0.19 g/m 2 dichlorvos (38.7 mL/m 2 spray)and the average residence size was 103±33 m 2 . Temperature and humiditywere 26.1°C and 82%, respectively. The spray was applied along thebaseboards, doorways, windows, all entrances, under the sink, stove andrefrigerator, shelves, cabinets and around plumbing and utility installations.Residents were advised not to re-enter their premise for two hours.“Conclusions: This study suggested that toxicologically-significantexposure of applicators and residents can occur during and immediatelyfollowing the application of dichlorvos. Although this study had somedeficiencies (such as the lack of reporting detail and the small sample sizes),it had qualitative value for risk assessment purposes.‖ (Originals notsighted; APVMA, 2008a)“In an intermediate-duration 21-day study in which volunteers weregiven dichlorvos orally, no signs of neurological toxicity were seen atdoses of 0.033 mg/kg [b.w.]/day (Boyer et al. 1977). Twenty-four malevolunteers had their serum cholinesterase and erythrocyteacetylcholinesterase determined twice a week for 3 weeks to establishtheir baseline levels. They were then given 0.9 mg dichlorvos 3 times aday for 21 days in either a pre-meal capsule or a 3-ounce container ofgelatin. Serum cholinesterase and erythrocyte acetylcholinesterasewere measured twice a week during the exposure period. Once a week,each volunteer had his vital signs measured, and was examined fortremor, pupillary response to light, and skin moisture. Following.theend of the study, serum cholinesterase and erythrocyteacetylcholinesterase were measured weekly for the next seven weeks.No clinical signs of neurological toxicity were observed in any of theDichlorvos reassessment – application Page 251 of 436

volunteers. Erythrocyte acetylcholinesterase was not inhibited at 0.033mg/kg [b.w.]/day in either the gelatin or capsule formulation. Serumcholinesterase was inhibited, on average, 38% in the group given thepre-meal capsule and 28% in the gelatin group. Measurements after thedosing period showed that the half-life for regeneration of serumcholinesterase was 13.7 days.” (Originals not sighted; ATSDR, 1997)The WHO (1978) reported:―Oral - Dichlorvos given to a group of 5 men in daily doses of 2.5 mgreduced after 20 days feeding plasma cholinesterase activity to 70% of preexposurelevel.―Symptoms of poisoning became evident when human subjects reached adose level of 8 mg/kg [b.w.] after receiving daily doubling doses starting at 1mg/kg [b.w.]. At this dosage the erythrocyte cholinesterase activity wasfound 20-55% of normal.―In studies designed to test the safety of using dichlorvos for thedisinsection of aircraft, a group of 15 volunteers underwent intermittentexposure totalling 5 hours per night, 4 nights per week, for 2 weeks, at aconcentration of 0.5 mg/m 3 of air; this produced a gradual, moderatereduction of plasma cholinesterase activity, but no illness, no impairment ofvisual performance, no increase in airway resistance of complex reactiontime, and no change in physical condition or neurological function. Therewas no inhibition of erythrocyte cholinesterase activity, and the lowestsingle plasma value observed was 34% of normal. Exposure to half thatconcentration for 10 half-hour periods each night for 10 weeks was toleratedwithout any effect, even on plasma cholinesterase.―Inhalation - Volunteers were exposed to an average dichlorvosconcentration of 5.8 mg/m 3 20 hours a day for up to 20 days. Plasmacholinesterase activity was reduced to 80%, 70% and 60% of normal after12, 24 and 48 hours respectively.‖ (Originals not sighted; WHO, 1978)Also see Section 25: Acceptable Operator Exposure Level (AOEL) – Key Study.Dichlorvos reassessment – application Page 252 of 436

25 ACCEPTABLE OPERATOR EXPOSURE LEVEL (AOEL)ERMA New Zealand usually sets one AOEL, derived from short or medium term(animal) studies with uncertainty factors and designed to protect the highest riskoccupational groups (such as contract sprayers) potentially exposed over seasonalperiods.AOELs are for systemic exposures, i.e. internal dose where any absorption factors(

25.1 Key Study:KEY STUDY: Oral• Type of study:• Species:• Strain:• Sex/Numbers:• Test material:• Dose levels:Minimal incipient toxicity, human;Human;Not applicable;4 or 5 males/test group; 2 male controls;Dichlorvos (unspecified source, Batch/Lot No. & purity);1.0, 1.5, 2.0 or 2.5 mg/day by capsule for 28 days (for70kg adult, equivalent to 0.014, 0.021, 0.029 and 0.036mg/kg b.w./day);• Endpoint: Symptoms; plasma and RBC ChE activities(potentiometric method of Michel (1949), which estimatesthe cholinesterase activity based on the change in pH withtime, ΔpH/hour); clinical chemistry, haematology andurinary parameters;• Remarks: No treatment-related symptoms or effect on anyhaematology, clinical chemistry or urinary parameter were reported. RBC ChEactivity was unaffected by treatment.No effect on plasma ChE activity at 1 or 1.5 mg/day was reported following 4weeks of dosing, however, no data were provided to substantiate this finding.At 2.0 mg/day, mean plasma ChE activity was depressed by >20% relative topretreatment activity from the second week of administration, reaching amaximum of 29% 3 days after treatment ended. When the data were correctedto account for this reduction in activity in the controls (up to 12%), the level ofinhibition in the dichlorvos group was approximately 20% from the secondweek of dosing (maximum of 25% at day 19). This was considered atoxicologically significant level of inhibition despite the absence of statisticalanalysis to support the finding. Three days after the cessation of dosing, plasmaChE activity remained depressed by 22%.At 2.5 mg/day, toxicologically-significant inhibition (>20% relative topretreatment activity) of plasma ChE activity occurred after 2 weeks of dosing.Treatment was stopped after 20 days because the level of inhibition hadreached 30%. Following a 15-day washout period, plasma ChE activityreturned to pretreatment levels.A supplementary group of subjects was treated with 1.5 mg/g dichlorvos.Progressive inhibition of plasma ChE activity occurred from the second week,reaching a maximum of 41% at the end of the 60-day treatment period (relativeDichlorvos reassessment – application Page 254 of 436

to pretreatment activity). When the data were corrected to account for thedeclining activity in the control group (up to 24%), inhibition of plasma ChEactivity in the dichlorvos subjects was 27% after 16 days and continued to bedepressed by 13-21% for the remainder of the dosing period. During the 74-day post-treatment period, plasma ChE activity recovered to control levelswithin 2 weeks. The author indicated that over a period of approximately 3weeks (corresponding to post-treatment days 31-48), there was a generaldecrease in plasma ChE activity in the performing laboratory due to a technicalproblem.• NOAEL =• LOAEL =• GLP:• Test Guideline:1.0 mg/day (0.014 mg/kg b.w./day for 70kg adult);1.5 mg/day (based on toxicologically-significant inhibition(>20% of pretreatment levels) of plasma ChE activity).No information;No information;• Reference source: Rider JA (1967) ―Determination of the minimal incipienttoxicity of dichlorvos in humans.‖ Report and Study no.unspecified. Lab: Gastrointestinal Research Laboratory,Franklin Hospital, San Francisco, CA, USA. Sponsor:Shell Chemical Company, Agricultural ChemicalsDivision, New York, New York, USA. Report date:October 1967. Unpublished. (Original not sighted;APVMA, 2008a);• Reliability:Klimisch score 2 = reliable with restrictions;Justification for Key Study status: Rider (1967) was not conducted to GLP or TestGuideline. However, the APVMA considered the study robust enough to use theNOAEL as basis of their occupational and residential risk assessments.Note: The APVMA (2008a) concluded that:“The NOEL was 1.0 mg/d[ay], based on toxicologically-significant inhibitionof plasma ChE activity at and above 1.5 mg/d[ay]. In the absence ofbodyweight data for the test subjects it is assumed that the average bodyweightfor young healthy men is 70 kg. Therefore the NOEL, using this figure, is0.014 mg/kg bw/d[ay].‖[See Appendix 1: APVMA - Summary of benchmarks used in occupational riskassessments, for fuller details.]KEY STUDY: Oral• Type of study:21-day capsule study in humans;Dichlorvos reassessment – application Page 255 of 436

• Species:• Strain:• Sex/Numbers:• Test material:• Dose levels:• Endpoint:Humans;Not applicable;6 males/group;Dichlorvos (AMVAC Chemical Corp., Batch/Lot No.6080028074; 98% purity);7.0 mg/day by capsule for 21 days (for 70kg adult,equivalent to 0.1 mg/kg b.w./day);Symptoms & clinical parameters; RBC ChE activities;clinical chemistry, haematology and urinary parameters;• Remarks: Sporadic symptoms were reported by both treated andplacebo groups, and none were attributed to treatment.A clear time-related increase in the inhibition of RBC ChE activity wasreported, which was not evident in the placebo group. Mean RBC ChE activitywas significantly lower (p

cholinesterase inhibition in healthy male volunteers.‖ (STUDY PROTOCOL)CTL Study No. XH6063. Lab: Zeneca Central Toxicology Laboratory,Alderley Park, Macclesfield, Cheshire, UK and Medeval Limited, Universityof Manchester, Manchester Science Park, Manchester, UK. Sponsor: AMVACChemical Corporation, unspecified location. Study duration: 5 th November1996 to an unspecified time. Report date: unspecified. October 1997. (Originalnot sighted; APVMA, 2008a);• Reliability: Klimisch score 2 = reliable with restrictions;Justification for Key Study status: The study by Gledhill (1997b & 1997c) andMorris (1996b) was conducted to GLP. The USEPA considered the study robustenough to use the NOAEL as basis of their occupational and residential riskassessments.Background:The US EPA have determined that ChE inhibition by organophosphorus pesticidesreaches a steady state after 21 to 28 days exposure (USEPA, 2006b) so these studyperiods are adequate for occupational and bystander/resident risk assessments.The US EPA prefers to use RBC AChE inhibition, because:―Although a pesticide‘s effect(s) on either RBC and plasma cholinesteraseactivity is considered to provide information on its potential to inhibit AChEin the nervous system, data from RBCs, which contain AChE exclusively,may better reflect neuronal AChE inhibition than data from the plasma,which is a variable mixture of butyrylcholinesterase andacetylcholinesterase.‖ (USEPA, 2000).The US EPA also reported levels of AChE inhibition and worker safety:―For example, the California Department of Health Services (CDHS)requires monitoring of agricultural workers who have contact with highlytoxic organophosphorous or carbamate compounds (EPA Toxicity CategoryI or II pesticides; LD 50 # 500 mg/kg in rats)(CDHS, 1988). CDHS removesworkers from the workplace whose plasma levels show 40% or greatercholinesterase inhibition from baseline, or whose red blood cellcholinesterase levels show 30% or greater inhibition. Workers may notreturn until their cholinesterase values return to within 80% of baseline. TheWorld Health Organization (WHO) also has guidelines with the same RBCaction levels (i.e., 30% or greater inhibition), and considers plasmainhibition of 50% of baseline to indicate a "toxic" decrease (Fillmore andLessinger, 1993).‖ (Originals not sighted; USEPA, 2000).The WHO (1987) reported a study where symptoms of poisoning became evident whenhuman subjects reached a dose level of 8 mg/kg b.w. and the RBC cholinesteraseactivity was found 20-55% of normal. Whereas, volunteers undergoing intermittentinhalation exposure that resulted in no inhibition of erythrocyte cholinesterase activity,and the lowest single plasma value observed was 34% of normal reported no illness, noDichlorvos reassessment – application Page 257 of 436

impairment of visual performance, no increase in airway resistance of complex reactiontime, and no change in physical condition or neurological function.The critical NOAELs/LOAELs set by overseas regulatory agencies are listed in thetable below:Critical NOAEL/LOAEL used for occupational exposure health benchmarks (mg/kgb.w./day)AcuteShort-term(1 day) a (1-30 Days a )Study Type(Reference)Intermediate(Seasonal, 1-6Months a )US EPA (2006a) Dermal BMDL 10 Dermal LOAEL == 0.8 c0.1Inhalation InhalationBMDL 10 = 0.8 c (vapours) LOAEL= 0.1 dRat acute oral (Twomey, 2002) bHuman 21D oral (Gledhill, 1997a &1997b)Inhalation(application)LOAEL = 0.1APVMA (2008b) Dermal NOAEL =0.014Human 28D oral (Rider, 1967)InhalationNOAEL = 0.014abUS EPA;Acute time point;c (0.8 mg/kg bw/day x 0.35kg / 0.34 m 3 /day = 0.8 mg/m 3 );d concentration equivalent = 0.35 mg/m 3 (= 0.1 mg/kg bw/day x 70kg / 20 m 3 /day);25.2 AOEL:Reliance on the NOAEL from Rider (1967) for occupational and bystander/resident riskassessments, in line with the APVMA, should give a conservative benchmark as:a) the Rider (1967) NOAEL is based plasma ChE, noted as the most sensitivemarker for repeat dichlorvos exposure; and,b) the action level used by the California Department of Health Services (CDHS)and guidance level recommended by the World Health Organization (WHO) toDichlorvos reassessment – application Page 258 of 436

protect agricultural workers who have contact with highly toxicorganophosphorous or carbamate compounds are ≥30% RBC ChE inhibition.Most data indicate RBC ChE inhibition would reach ~20% (as used by the USEPA; Gledhill, 1997b & 1997c) at approximately 10x the Rider (1967) NOAELdose.Proposed AOEL:AOEL = NOAEL x AF = 0.014 x 1.0= 0.0014 mg/kg b.w./dayUFs 10From the 28-day human volunteer capsule study (Rider, 1967 in APVMA, 2008aand US EPA, 2006a).Where UFs: inter-species = 1 as the study was carried out in humans; intra-species= 10 to account for individual variability; and AF (absorption factor) = 1.0 (100%)for oral absorption.Dichlorvos reassessment – application Page 259 of 436

Absorption factors:[See Section 4 ADME for further discussion on absorption.]Dermal absorption factorThe APVMA, US EPA and Cal DPR all reviewed Jeffcoat (1990) [MRID 41435201]and used this study as the basis of their dermal absorption factors, respectively 30, 11and 13%.The discrepancy between the APVMA and US EPA (and Cal DPR) dermal absorptionfactors, although based on the same study and data, is due to their differentinterpretations on what constitutes absorbed material. The APVMA have considered―dermal absorption‖, to include that amount of material remaining in the skin at the timethe study ended, approximately 22-30% predominately within the first 10 hours(carcass, skin, urine, faeces, blood and expired air). Whereas the US EPA have onlyconsidered ―dermal penetration‖, that excluded the material in the skin and onlyincluded that in the carcass, urine, faeces, blood and expired air, approximately 6-11%.At the medium and highest dose rates (3 & 30 μg/cm 2 ) the dermal absorption valueswere higher at 10 hours than at later time points, while at the lowest dose (0.5 μg/cm 2 )the percentage of the applied dose absorbed was slightly higher.(APVMA, 2008a)The available data do not conclusively show if the skin acts as a reservoir of dichlorvosor not. However, at 120 hours the radioactivity in carcass and blood has declined, whilethat in urine, faeces and expired air has increased, indicating that any materialpenetrating the skin after the first 10 hours does not appear to be contributing to peakbody burden (systemic dose), but may maintain levels over toxic thresholds. Thedegradation of dichlorvos by tissue esterases, particularly in the liver and theserum is described as rapid, but the differences in oral and dermal LD50 values(oral: 46.4 mg/kg b.w.; dermal: 75 mg/kg b.w. for females) does not indicate othersignificant factors for oral to dermal extrapolations.Therefore, 30% is recommended as the dermal absorption factor as the mostconservative value for occupational and bystander/resident risk assessments.Dichlorvos reassessment – application Page 260 of 436

Wash: refers to skin washes; Dressing: refers to test material in the covering dressing itself; Charcoalfilter: refers to material absorbed into charcoal filters placed under the covering dressings (vapour).(APVMA, 2008a)Inhalation absorption factorThe APVMA concluded that a 70% inhalation absorption factor would be used for riskassessment purposes, based on a study (Kirkland, 1971) evaluated by the WHO (1988)that demonstrated that at dichlorvos concentrations of 0.1–2.0 mg/m 3 , pigs retained 15–70% of the inhaled dichlorvos. (APVMA, 2008b)The US EPA has used 100% for the inhalation absorption factor (US EPA, 2006).Due to paucity of data, 100% inhalation absorption factor is recommended.Oral absorption factorThe APVMA evaluated oral absorption to be almost complete (93-96%) and rapidTmax < 0.5h (APVMA, 2008a).100% oral absorption factor is recommended.Dichlorvos reassessment – application Page 261 of 436

26 SUMMARY & CONCLUSIONSCLASS 6 & 8 Toxicological Hazard Classifications:Hazard Class/SubclassHazardclassificationMethod of classificationReferenceSubclass 6.1 Acutetoxicity (oral)Subclass 6.1Acute toxicity(dermal)Subclass 6.1 Acutetoxicity (inhalation)Subclass 6.3/8.2 Skinirritancy/corrosionSubclass 6.4/8.3 Eyeirritancy/corrosion6.1B LD 50 (rat, oral) = 46.4 mg/kg b.w.GLP: NoGuideline: NoKlimisch score 2 = reliable withrestrictions6.1B LD 50 (rat, dermal) = 75 mg/kg b.w.GLP: NoGuideline: NoKlimisch score 2 = reliable withrestrictions6.1B LC 50 (rat, head-only; mist) = 0.447mg/LGLP: YesGuideline: OECD [403?]Klimisch score 2 = reliable withrestrictions6.3B Primary dermal irritation (rabbit)GLP: NoGuideline: OECD 404Klimisch score 2 = reliable withrestrictions6.4A Primary eye irritation (rabbit)GLP: NoGuideline: OECD 405Klimisch score 2 = reliable withrestrictionsCiba-Geigy (1973)(APVMA, 2008a)Durham et al. (1957)(ATSDR, 1997)Pauluhn J (1984)(APVMA, 2008a)Pauluhn J (1985)(APVMA, 2008a)Pauluhn J (1985)(APVMA, 2008a)Subclass 6.5A RespiratorysensitisationInsufficientdataNo dataAPVMA, USEPA,ATSDR, WHODichlorvos reassessment – application Page 262 of 436

Hazard Class/SubclassHazardclassificationMethod of classificationReferenceSubclass 6.5B Contactsensitisation6.5B Maximisation Test (Guinea Pig)GLP: NoGuideline: NoKlimisch score 2 = reliable withrestrictionsUeda et al. (1994)(APVMA, 2008a)Subclass 6.6 Mutagenicity 6.6B Weight of evidence:Dichlorvos is mutagenic andclastogenic at the point of contact,where unchanged dichlorvos may be indirect contact with tissue [DDVP‘sinherent potential]. There is noevidence that dichlorvos has anysystemic genotoxic potential, due tothe substance‘s inherentphosphorylating reactivity and thehighly efficient biotransformation [lowrisk].APVMA, USEPA,ATSDR, WHOSubclass 6.7Carcinogenicity6.7B Weight of evidence:The increased incidence of adenomasof the exocrine pancreas in maleF344/N rats after dietary exposureindicated equivocal evidence ofcarcinogenic activity of dichlorvos, asan inhalation study revealed no similareffects. The increased incidences offorestomach squamous cell papillomasin male and female B6C3F1 mice afterdietary exposure indicated someevidence. While forestomach tumoursare not considered directly relevant tohumans, these findings (and themutagenic potential in certain contactscenarios) indicate that repeatedexposure to high concentrations ofdichlorvos poses some carcinogenichazard, even though the occupationand residential risks are seen asnegligible.APVMA, USEPA,ATSDR, WHOSubclass 6.8 ReproductivetoxicityNoOPPTS 870.3800 (Reproductive);OECDTyl (1992) in APVMA,2008aGLP: US EPA, 40 CFR Part 160;USEPA, ATSDR, WHOKlimisch score 2 = reliable withrestrictionsDichlorvos reassessment – application Page 263 of 436

Hazard Class/SubclassHazardclassificationMethod of classificationReferenceSubclass 6.8Developmental toxicityNo(Rat, developmental)(Rabbit, develop.)GLP: US EPA, 40 CFR Part 160;Tyl (1990a and 1990b) inAPVMA, 2008aUSEPA, ATSDR, WHOKlimisch score 2 = reliable withrestrictionsSubclass 6.8 Category CInsufficientdata for CInsufficient data for Classification onlactation effects (C)APVMA, USEPA,ATSDR, WHOSubclass 6.9 Target organsystemic toxicity – Singleexposure (Oral)Subclass 6.9 Target organsystemic toxicity – Singleexposure (Dermal)Subclass 6.9 Target organsystemic toxicity – Singleexposure (Inhalation)Subclass 6.9 Target organsystemic toxicity – Repeatexposure (Oral)6.9A LOAEL = 35 mg/kg b.w., based onclinical signs of neurotoxicity (FOB)(peak effect 15 mins)US EPA Guideline Series 81-8 (1991);GLP: US EPA, 40 CFR Part 160;Klimisch score 2 = reliable withrestrictions6.9B LOAEL = 150 mg/kg b.w., based onclinical signs of neurotoxicity;Guideline: No information;GLP: No information;Klimisch score 2 = reliable withrestrictions6.9A LOAEL = 0.23-1.926 mg/L, based onclinical signs of neurotoxicity;Guideline: OECD 403?;GLP: Yes;Klimisch score 2 = reliable withrestrictions6.9A LOAEL = 3.2 ppm (equivalent to 0.08mg/kg b.w./day) based on inhibition ofRBC ChE activity in males(Dog, 2-Yr Dietary)Lamb (1993a) inAPVMA, 2008aUSEPA, ATSDR, WHOTierfarm (1969b) inAPVMA, 2008aPauluhn (1984) inAPVMA, 2008aJolley et al. (1967) inAPVMA, 2008aLOAEL = 1.0 mg/kg b.w./day, basedon inhibition of plasma and RBC ChEactivities.US EPA; 40 CFR Part 160;Markiewicz (1990) inAPVMA, 2008aUSEPA, ATSDR, WHODichlorvos reassessment – application Page 264 of 436

Hazard Class/SubclassHazardclassificationMethod of classificationReferenceUS EPA (Subdivision F, series 158,83-1) (Dog, 52-Wk Capsule)Klimisch score 2 = reliable withrestrictionsSubclass 6.9 Target organsystemic toxicity – Repeatexposure (Dermal)InsufficientdataNo adequate studies were reportedAPVMA, USEPA,ATSDR, WHOSubclass 6.9 Target organsystemic toxicity – Repeatexposure (Inhalation)APVMA: APVMA, 2008a;USEPA: USEPA, 2006a;ATSDR: ATSDR, 1997;WHO: WHO, 1988 & 1993.6.9A LOAEL = 0.5 mg/m3 (approximatelyequal to 2.5 mg/kg/ b.w./day) based onthe inhibition of plasma and RBC ChEactivity;GLP: NoGuideline: NoKlimisch score 2 = reliable withrestrictionsBlair et al. (1974 &1976) in APVMA, 2008aUSEPA, ATSDR, WHOThe level of detail in the APVMA Chemical Review (2008a), the US EPAReregistration Eligibility Decision for Dichlorvos (2006a), the ATSDR ToxicologicalProfile (1997) and WHO reports (1988 & 1993), should give adequate assurance thatthe proposed Classifications are robust, based on the documents cited in the Referencesection.Key Studies for AOEL benchmark:Critical NOAEL/LOAEL used for occupational exposure health benchmarks (mg/kgb.w./day)AcuteShort-term(1 day) a (1-30 Days a )Study Type(Reference)Intermediate(Seasonal, 1-6Months a )US EPA (2006a) Dermal BMDL 10 Dermal LOAEL = Rat acute oral (Twomey, 2002) bDichlorvos reassessment – application Page 265 of 436

Critical NOAEL/LOAEL used for occupational exposure health benchmarks (mg/kgb.w./day)= 0.8 c0.1Inhalation InhalationBMDL 10 = 0.8 c (vapours) LOAEL= 0.1 dHuman 21D oral (Gledhill, 1997a &1997b)Inhalation(application)LOAEL = 0.1APVMA (2008b) Dermal NOAEL =0.014Human 28D oral (Rider, 1967)InhalationNOAEL = 0.014abUS EPA;Acute time point;c (0.8 mg/kg bw/day x 0.35kg / 0.34 m 3 /day = 0.8 mg/m 3 );d concentration equivalent = 0.35 mg/m 3 (= 0.1 mg/kg bw/day x 70kg / 20 m 3 /day);Proposed AOEL:AOEL = NOAEL x AF = 0.014 x 1.0 = 0.0014 mg/kg b.w./dayUFs 10From the 28-day human volunteer capsule study (Rider, 1967 in APVMA, 2008aand US EPA, 2006a).Where UFs: inter-species = 1 as the study was carried out in humans; intra-species= 10 to account for individual variability.Based on the current available data package for dichlorvos, TCL has proposed:• dermal absorption at 30% for occupational and bystander/resident health riskmodelling.• inhalation absorption at 100% for occupational and bystander/resident healthrisk modelling.• oral absorption at 100% for occupational and bystander/resident health riskmodelling.Dichlorvos reassessment – application Page 266 of 436

REFERENCES:APVMA, 2008a. ―DICHLORVOS - Toxicology Assessment: The reconsideration ofapprovals of the active constituent, registrations of products containing dichlorvos andapprovals of their associated labels.‖ Australian Pesticides & Veterinary MedicinesAuthority, KINGSTON ACT 2604; 2008.APVMA, 2008b. ―DICHLORVOS - OCCUPATIONAL HEALTH AND SAFETYASSESSMENT: The reconsideration of approvals of the active constituent, registrationsof products containing dichlorvos and approvals of their associated labels.‖ AustralianPesticides & Veterinary Medicines Authority, KINGSTON ACT 2604; 2008.ATSDR, 1997. “TOXICOLOGICAL PROFILE FOR DICHLORVOS” Agency for ToxicSubstances and Disease Registry, Atlanta, Georgia 30333; 1997.CCRIS, 2008. Chemical Carcinogenesis Research Information System (CCRIS) 2008:DICHLORVOS CASRN: 62-73-7.ERMA, 2008. ―User Guide to the Thresholds and Classifications in the HSNO Act.‖v2.0 March 2008: ER-UG-03-2 02/08. ERMA New Zealand, WELLINGTON.IARC, 1991. ―International Agency for Research on Cancer (IARC) - Summaries &Evaluations: DICHLORVOS (Group 2B).‖ VOL.: 53 (1991) (p. 267).http://www.inchem.org/documents/iarc/vol53/06-dichlorvos.htmlPletsa V, Steenwinkel MJ, van Delft JH, Baan RA, Kyrtopoulos SA., 1999. ―Inductionof somatic mutations but not methylated DNA adducts in lambdalacZ transgenic miceby dichlorvos.‖ Cancer Lett. 1999 Nov 15;146(2):155-60.Schop RN, Hardy MH, Goldberg MT., 1990. ―Comparison of the activity of topicallyapplied pesticides and the herbicide 2,4-D in two short-term in vivo assays ofgenotoxicity in the mouse.‖ Fundam Appl Toxicol. 1990 Nov;15(4):666-75.Tungul, A., Bonin, A.M., He, S., Baker R.S.U., 1991. ―Micronuclei induction bydichlorvos in the mouse skin.‖ Mutagenesis vol. 6 no. 5 pp. 405-408, 1991.US EPA, 2000. ―Science Policy on The Use of Data on Cholinesterase Inhibition forRisk Assessments of Organophosphorous and Carbamate Pesticides.‖ August 18, 2000.Office of Pesticide Programs, US Environmental Protection Agency, Washington DC20460.US EPA, 2006a. ―Reregistration Eligibility Decision for Dichlorvos (DDVP).‖ Officeof Pesticide Programs, UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY, WASHINGTON D.C., 20460.US EPA, 2006b. ―Organophosphorus Cumulative Risk Assessment – 2006 Update‖(August 2006) U.S. Environmental Protection Agency, Office of Pesticide Programs.WHO, 1978. ―DICHLORVOS.‖ DATA SHEETS ON PESTICIDES No. 2 (Rev.1)August 1978, World Health Orgnization, Geneva,Dichlorvos reassessment – application Page 267 of 436

WHO, 1988. ―INTERNATIONAL PROGRAMME ON CHEMICAL SAFETYENVIRONMENTAL HEALTH CRITERIA 79: DICHLORVOS.‖ World HealthOrgnization, Geneva, 1988.WHO, 1993. ―859_ Dichlorvos (Pesticide residues in food 1993 evaluations Part IIToxicology).” World Health Orgnization, Geneva.Dichlorvos reassessment – application Page 268 of 436

Appendix 1:APVMA - Summary of benchmarks used in occupational riskassessments (APVMA, 2008b).“NOELs for Occupational Health & Safety Assessment―Dichlorvos products intended for professional use are most likely to be applied byPCOs [pest control operators], horticulturalists and operators of grain storage facilitiesand flour mills. Depending on pest activity, PCOs may use dichlorvos products onseveral days or daily during the working week. Repeated use of dichlorvos for treatmentof commercial and industrial buildings could result in daily exposure of buildingoccupants, given that dichlorvos has been detected in workplace atmospheres for up to afortnight after application (Schofield, 1993). Grain storage operators and avocadogrowers are more likely to be exposed on a seasonal basis, but also may be exposed onseveral days in succession. Exposure of horticulturalists would be dictated by thegrowth cycle of mushrooms or plants under cultivation, and could occur regularly onsingle days but with several days or more between uses. The most likely potential routesof exposure would be by dermal contact with the undiluted products or spray mixture,and by inhalation of dichlorvos vapour or aerosols.“Dermal NOEL for Occupational Exposure Assessment―Short-term repeat-dose toxicity studies of up to 28 days‘ duration are considered to bethe most appropriate for derivation of NOELs for occupational health and safetyassessment of product users who are exposed repeatedly. The most relevanttoxicological end-point for occupational exposure to dichlorvos is plasma ChEinhibition, as in a repeated exposure scenario, there would be scope for progressivelyincreasing inhibition of plasma ChE activity if the (less sensitive) RBC ChE inhibitionwere used as the pivotal end-point. Although repeat-dose studies via the dermal routewould be optimal for derivation of occupational health and safety NOELs, no suchstudies with dichlorvos are available. The assessment therefore must be performedusing studies undertaken by oral administration. A summary of NOELs determined inoral studies considered adequate for regulatory purposes is shown in the followingtable:Dichlorvos reassessment – application Page 269 of 436

―It is considered that the most suitable endpoint for estimation of occupational risks fordermal exposures is an oral NOEL of 0.014 mg/kg bw/d[ay], established in the 28-d[ay]oral study in humans by Rider (1967). The study is highly suitable because itdemonstrated a NOEL and a LOEL for plasma ChE inhibition and was performed withhuman subjects, thereby eliminating uncertainty associated with inter-speciesextrapolation. Adjusting for a dermal absorption factor of 30%, the resulting dermalNOEL becomes 0.047 mg/kg bw/d[ay]. The acceptable margin of exposure (MOE) is >10, resulting from application of a 10-fold uncertainty factor for intra-speciesvariability. No correction for an internal dose is required since absorption from the GITis almost complete (93 – 96%).Dichlorvos reassessment – application Page 270 of 436

“Inhalational NOEL for Occupational Exposure Assessment―Due to the volatile nature of dichlorvos, there is highly significant potential for productusers to be exposed via inhalation, especially during spray application. For productusers, the frequency of inhalation exposure in an occupational setting would be thesame as for dermal exposure, as discussed above. Persons exposed occupationally intreated buildings are likely to be exposed by inhalation repeatedly on successive days.―Several short-term studies have been undertaken in which ChE activity was measuredin humans exposed to dichlorvos by inhalation. However, their usefulness is limited byuncertainty concerning the NOECs and/or the airborne concentrations of dichlorvos towhich the subjects were exposed. It is therefore necessary to perform the assessmentusing studies carried out by oral administration. As discussed previously, the mostsuitable study for estimation of occupational risks is that of Rider (1967), in which theNOEL was 0.014 mg/kg bw/d[ay]. Adjusting for the inhalation absorption factor of70%, the resulting NOEL becomes 0.02 mg/kg bw/d[ay]. This value should be used forrisk assessment of professional users during application and on restricted entry intotreated areas. The acceptable margin of inhalation exposure (MOE) is > 10, resultingfrom application of a 10-fold uncertainty factor for intraspecies variability.‖ (APVMA,2008b)Key Study:“Rider JA (1967) Determination of the minimal incipient toxicity of dichlorvos inhumans. Report and Study no. unspecified. Lab: Gastrointestinal Research Laboratory,Franklin Hospital, San Francisco, CA, USA. Sponsor: Shell Chemical Company,Agricultural Chemicals Division, New York, New York, USA. Report date: October1967.Materials and Methods―Dichlorvos (unspecified source, Batch/Lot No. & purity), formulated in corn oil, wasadministered to ―healthy young men‖ in gelatine capsules at 1.0, 1.5, 2.0 or 2.5mg/d[ay] for 28 days (equivalent to 0.014, 0.021, 0.029 and 0.036, respectively,assuming an average bodyweight of 70 kg). The doses were split between two capsules,which were ingested at 8 am and 3 pm. Few details were given regarding the subjects(such as age and bodyweight) other than that they were serving sentences at theCalifornian Medical Facility, Vacaville, California, USA. Each subject was physicallyexamined and interviewed prior to the commencement of dosing. At each dose, 4 or 5subjects received the capsules containing dichlorvos, while 2 control subjects receivedcapsules containing only corn oil. An additional group of subjects received 0 (n=2) or1.5 mg/d[ay] (n=10) dichlorvos over 60 days followed by a recovery period of 74 days.Analysis of the concentration and stability of dichlorvos was not performed.―All subjects were interviewed on a weekly basis and any symptoms recorded. Baselineplasma and RBC ChE activities were analysed over a 14-28 day period prior to dosingusing the potentiometric method of Michel (1949), which measures the ΔpH/h. Plasmaand RBC ChE activities were analysed 24 hours after the first dose and then twiceweekly throughout the study. In the additional group of subjects dosed with 1.5mg/d[ay], plasma and RBC ChE activities were measured during the 74-day recoveryperiod. The following clinical chemistry parameters were measured prior to treatmentDichlorvos reassessment – application Page 271 of 436

and on a weekly basis for 4 weeks: SGOT, alkaline phosphatase, prothrombin time,thymol turbidity and total bilirubin. The following haematology parameters weremeasured prior to treatment and on a weekly basis for 4 weeks of dosing: Hct, Hb,RBC, WBC and WBC-DC. The following urinary parameters were measured prior totreatment and on a weekly basis for 4 weeks of dosing: pH, colour, character, specificgravity, albumin, sugar, leucocytes, erythrocytes, epithelial cells, casts, crystals,amorphous and other.―No statistical analysis was performed.Results―There were no treatment-related symptoms. There was no treatment-related effect onany haematology, clinical chemistry or urinary parameter. RBC ChE activity wasunaffected by treatment.―It was reported that there was no effect on plasma ChE activity at 1 or 1.5 mg/d[ay]following 4 weeks of dosing, however, no data were provided to substantiate thisfinding. At 2.0 mg/d[ay], mean plasma ChE activity was depressed by >20% relative topretreatment activity from the second week of administration, reaching a maximum of29% 3 days after treatment ended (see Table below). However, the concurrent controlgroup also showed a reduction in plasma ChE activity (up to 12%) relative to its meanbaseline activity. When the data were corrected to account for this reduction in activityin the controls, the level of inhibition in the dichlorvos group was approximately 20%from the second week of dosing (maximum of 25% at day 19). This was considered atoxicologically significant level of inhibition despite the absence of statistical analysisto support the finding. Three days after the cessation of dosing, plasma ChE activityremained depressed by 22%.Plasma ChE activity in male subjects treated with 2.0 mg/d dichlorvos―Results expressed as the mean ΔpH/h, with the % inhibition relative to pretreatment activity contained inparentheses. The range is shown for the dichlorvos group in parentheses; 1 = % inhibition in the controlgroup subtracted from the % inhibition of the dichlorvos group; 2 = average of 4 measurements for eachsubject.―At 2.5 mg/d[ay] (see Table below), toxicologically-significant inhibition of plasmaChE activity occurred after 2 weeks of dosing (ie. >20% relative to pretreatmentDichlorvos reassessment – application Page 272 of 436

activity). In fact, treatment was stopped after 20 days because the level of inhibition hadreached 30%. Following a 15-day washout period, plasma ChE activity returned topretreatment levels.Plasma ChE activity in male subjects treated with 2.5 mg/d dichlorvos―Results expressed as the mean ΔpH/h, with the % inhibition relative to pretreatment activity contained inparentheses. The range is also shown for the dichlorvos group in parentheses; 1 = average of 4measurements for each subject.―In the supplementary group of subjects treated with 1.5 mg/g dichlorvos (see Tablebelow), progressive inhibition of plasma ChE activity occurred from the second week,reaching a maximum of 41% at the end of the 60-day treatment period (relative topretreatment activity). However, the magnitude of this effect was partially negated bythe up to 24% reduction in plasma ChE activity in the concurrent controls over the sametime. When the data were corrected to account for the declining activity in the controlgroup, inhibition of plasma ChE activity in the dichlorvos subjects was 27% after 16days and continued to be depressed by 13-21% for the remainder of the dosing period.During the 74-day post-treatment period, plasma ChE activity recovered to controllevels within 2 weeks. The author indicated that over a period of approximately 3 weeks(corresponding to post-treatment days 31-48), there was a general decrease in plasmaChE activity in the performing laboratory. This was apparently remedied when a freshacid cleaning solution was employed to clean the laboratory glassware used for the ChEassay.Dichlorvos reassessment – application Page 273 of 436

Plasma ChE activity in additional male subjects treated with 1.5 mg/d dichlorvos―Results expressed as the mean ΔpH/h, with the % inhibition relative to pretreatment activity contained inparentheses. The range is shown for the dichlorvos group in parentheses; 1 = only results for every secondtime point are shown; 2 = % inhibition in the control group subtracted from the % inhibition of thedichlorvos group; 3 = data for one control subject only compared to his own baseline activity of 0.851.“Conclusions: The NOEL was 1.0 mg/d[ay], based on toxicologically-significantinhibition of plasma ChE activity at and above 1.5 mg/d[ay]. In the absence ofbodyweight data for the test subjects it is assumed that the average bodyweight foryoung healthy men is 70 kg. Therefore the NOEL, using this figure, is 0.014 mg/kgbw/d[ay].‖ (Original not sighted; APVMA, 2008a)Dichlorvos reassessment – application Page 274 of 436

LAST PAGEDichlorvos reassessment – application Page 275 of 436

Appendix G: Human Health Risk AssessmentDichlorvos reassessment – application Page 276 of 436

Dichlorvos:Occupational, Bystander, and ResidentRisk AssessmentsFor:ERMA New Zealand20 Customhouse QuayPO Box 131WellingtonNEW ZEALANDPrepared by:Martin Edwards PhDToxicology Consulting Ltd36 Hastings ParadeDevonport 0624North Shore Cityedwardsm@ihug.co.nzVersion: V8March, 2010Dichlorvos reassessment – application Page 277 of 436

1 PURPOSE1.1 The purpose of this report is to provide occupational, bystander, and residentrisk assessments for the Environmental Risk Management Authority NewZealand (ERMA New Zealand) reassessment of dichlorvos.1.2 The scope of the context used to form this assessment is confined to thedocuments listed in the Reference section of this document, the time constraints,the professional experience of the author, and the date this document was issued.1.3 The assessment constitutes the whole document and the reference sources, andshould only be used as a whole.1.4 In spite of all care taken, the reference material should be directly consulted tocheck the veracity of data, opinions and other material used and attributed in thisdocument.1.5 No responsibility will be taken for misuse of this document, or use by thirdparties.Dichlorvos reassessment – application Page 278 of 436

CONTENTS:Title Page 11 Purpose 2Contents 32 Substance Identification 43 Activity Scenarios 54 Operator Exposure & Risk Assessment 85 Post-application or Re-entry Worker Exposures & Risk Assessment 336 Bystander & Resident Exposure & Risk Assessment 587 Summary & Conclusions 67References 74Appendix 1: Occupational Exposure Estimates & Risk Assessment withEngineering Controls 76Appendix 2: Occupational Exposure Estimates & Risk Assessment withRTU gas cylinders 79Appendix 3: Occupational Exposure Estimates & Risk Assessment for SprayApplications into Enclosed Spaces 86Appendix 4: Occupational Exposure Estimates & Risk Assessment for SprayApplications into Public Spaces 89Appendix 5: Re-entry Worker Exposure Estimate and Risk Assessment 92Appendix 6: Resident Exposures and Risk Assessment 94Last Page 103Dichlorvos reassessment – application Page 279 of 436

2SUBSTANCE IDENTIFICATIONIUPAC name:Chemical name (CAS):Common name:2,2-dichlorovinyl dimethylphosphate2,2-dichloroethenyl dimethylphosphate; Phosphoric acid,2,2-dichloroethenyl dimethyl esterDichlorvos; DDVPCAS Registry number: 62-73-7Molecular formula: C 4 -H 7 -C l2 -O 4 -PMolecular weight: 220.97Structural formula:(ChemID; HSG 18, 1988)Vapour pressure: 0.0158 mm Hg = 2.1 Pa (CCID, 2009)Dichlorvos reassessment – application Page 280 of 436

3ACTIVITY SCENARIOS3.1 Table (I) summarises the uses of dichlorvos from which occupational, bystanderand resident exposures and health risks have been estimated.Table I: Dichlorvos Use ScenariosScenario Crop/Use Method Rate ApplicationsOutdoorEquipment Details Formu-lationApplicationrateArea orvolumetreatedNo. peryearInterval(days)1 Strawberries Low boom Fine – EC 800 20 ha 1 -mediumg a.i./ha2 droplet2 73 Vegetables, High boom Fine – EC 800 20 ha 1 -cereals,mediumg a.i./ha4 berriesdroplet2 75 FruitAirblast FinemediumEC 2052 8 ha 1 -6g a.i./haberry)(tamarillo/persimmons/droplet2 79 Glasshouse Automatic Fog RTU 0.05 25000 m 3 1 -crops/ applicationgas g/m 3 (1.25 ha)10mushrooms2 711 EC 1 -Fog12 2 713 Glasshouse Automatic Fog/low EC 1300 0.1 ha 1 -flowers application volumeg a.i./ha (2500 m 3 )14 (Cymbidium)mister2 77 Passionfruit Knapsack Finemediumg a.i./haEC 1026 1 ha 1 -8 droplet2 715 Hand held Finemediumg a.i./ha (5000 m 3 )EC 1800 0.2 ha 1 -sprayer16 droplet2 7Indoor17 Enclosed Automatic Fog RTU 0.05 & 0.15 375, 1 -space applicationgas g a.i./ m 3 3750 &18 (industrial)12500 2 7m 3 )19 Manual Fog RTU 0.05 & 0.151 -Foggergas g a.i./ m 3 2 720 Automatic Fog EC 0.05 & 0.151 -21applicationg a.i./ m 32 7Dichlorvos reassessment – application Page 281 of 436

Table I: Dichlorvos Use ScenariosScenario Crop/Use Method Rate ApplicationsEquipment Details Formu-lationApplicationrateArea orvolumetreatedNo. peryearInterval(days)22 Manual Fog EC 0.05 & 0.151 -23foggerg a.i./ m 32 724 High Fine- EC 0.1 & 0.3 150, 1 -pressure mediumg a.i./ m 2 1500 &25 hand-wand droplet2500 m 2 2 7orequivalent26 Domestic use RTU Aerosol 3.1 0.25 g 7.44 m 2 1 -aerosol (manual g a.i./L a.i./m 227 )2 728 Knapsack FinemediumRTU 0.3 g a.i./m 2 60 m 2 1 -29liquida.i./L;4Lpack)droplet (4.4g2 7Outdoor – public space30 Public outdooruseManualfoggerFog EC 1500 ga.i./ha1 ha 1 -3.2 The occupational (work) activities for which exposure is estimated are mixing,loading (usually grouped, M/L) and application, together termed operatorexposures, and workers entering the spray area after application, for example toweed or harvest the crop, termed post-application or re-entry activities.3.3 To estimate risks to operators at application and workers entering the sprayedareas post-application, exposures are predicted under likely use patterns, takinginto consideration the time worked, and the use of mitigation measures.3.4 During mixing, loading and application mitigation measures include: engineeringcontrols such as contained or closed mixing and loading systems, and closed cabswith or without filtered air supplies; Personal Protective Equipment (PPE); and/orRespiratory Protective Equipment (RPE).3.5 For workers post-application mitigation measures include: recommendations notto (re-)enter sprayed areas for set periods, or Restricted Entry Intervals (REI); PPEand/or RPE.3.6 For bystanders, risks to residents are only estimated from exposure of a child tosurfaces contaminated either by being directly sprayed or from spray drift,because of concerns with model approaches for assessing direct exposures tospray drift or re-volatilised spray. In certain circumstances, such as workplaces,Dichlorvos reassessment – application Page 282 of 436

access of bystanders to treated areas can be restricted after application, but PPEand RPE cannot be considered as mitigation measures.3.7 Estimated exposures based on models are compared to the relevant health hazardbenchmark (Acceptable Operator Exposure Level, AOEL). The AOEL proposedfor dichlorvos is 0.0014 mg/kg b.w./day [based on the NOAEL from the 28-dayhuman volunteer capsule (oral) study by Rider (1967 in APVMA, 2008a and USEPA, 2006a).]Dichlorvos reassessment – application Page 283 of 436

4OPERATOR EXPOSURE & RISK ASSESSMENT4.1 For occupational situations the main routes of exposure are assumed to be throughthe skin (dermal) or by inhalation. Ingestion of pesticide is not considered inoccupational estimates, as it should not occur in a trained work force. No separateassessment for multiple applications is necessary because the daily exposure isestimated and this is compared to the AOEL which takes into account that theworker may be exposed daily and allows for repeat exposure.4.2 As ERMA New Zealand has no actual exposure data measured in the field underNew Zealand conditions, operator (mixer/loader/applicator) exposures wereestimated by TCL using the United Kingdom Chemicals Regulation Directorate(Pesticides)‘s (UK CRD, 1992) interpretation of the German BBA Model. Thederived values consider both dermal and inhalation exposure routes using thegeometric mean exposure estimates.4.3 The BBA model calculates total systemic exposure or the total absorbed dosefrom both routes. The default assumption is that 100% of the inhaled material isabsorbed, and for dichlorvos this default value is used. However, estimation ofdermal absorption (skin penetration) is usually more complex.4.4 After reviewing the available data, TCL used 30% as the proportion of dichlorvosthat would be absorbed from exposed skin for both concentrate and spray mix, inconcordance with the value used by APVMA, based on studies with rats (Jeffcoat,1990; Original not sighted in APVMA, 2008a). These data were also used by USEPA (2006a; 11%) and Californian Department of Pesticide Regulation (CalDPR,1996; 13%), but these regulators did not use the highest rate of absorption found,but an average.4.5 The BBA model allows exposure estimates to be made with and without a limitedrange of PPE and/or RPE for mixing/loading and application. Mixer/loaderexposures can be modelled with or without gloves, and with or without respirators(either A1P2 or FFP2SL/P2 specification). Applicator exposures can be modelledwith or without head covering (hood + visor or broad-brimmed headgear), glovesand extra body covering (coverall + sturdy footwear), and respirators (either A1P2or FFP2SL/P2 specification). Each item of PPE diminishes exposure to thecovered part of the body by a set protective factor (i.e. allows a percentagetransmission). Similarly, the different RPE mitigate inhalation exposures by setprotective factors. [Note: For some scenarios other models have been used, suchas UK POEM 07, which may present different RPE/PPE options with possiblydifferent protective factors.] The risk assessment is done by calculating the RiskQuotient (RQ = estimated exposure/AOEL). If the RQ for a particular activity isunacceptable (RQ >1) then further exposure mitigation, such as engineeringcontrols, may be considered in the models.4.6 Contained or closed mixing and loading systems can be used, which reduce thedermal exposure to mixers/loaders while readying the application equipment foruse. The US EPA considers that a correctly used and maintained closed systemDichlorvos reassessment – application Page 284 of 436

can reduce dermal exposures to mixer/loaders by 2.7 fold (a factor of 0.37)(Franklin & Worgan, 2005) [see Appendix 1].4.7 Enclosed cabs on motorised ground equipment can reduce the dermal, and if fittedwith appropriate filtered ventilation systems, inhalation exposures to applicatorsduring spraying. The US EPA considers that a correctly used and maintainedenclosed cab/filtration system can reduce exposures to applicators by 3 fold (afactor of 0.33) when using ground-booms and by 13.4 fold (0.075) with air-blastequipment (Franklin & Worgan, 2005) [see Appendix 1].4.8 Tables II, III, and IV show the modelled operator exposures and risks for theoutdoor activities with dichlorvos based on the BBA model, with and without PPEand RPE, and with and without engineering controls (for Scenarios 1-4, 5 & 6).For Scenarios (7 & 8), that use hand-held sprayers, no enclosed cab is possibleand it has been assumed that no closed mixing and loading system would beavailable for such small quantities.4.9 Scenarios 9-14 where applications are indoors (greenhouses, mushroom houses) itis assumed that the application equipment is automatic or remote (i.e. applicatorsare not in the space being treated), so that occupational exposure is confined tomixer/loader, or in the case of gas products, connecting/disconnecting cylinders.4.10 The APVMA re-assessment (APVMA, 2008b) considered that operators might beexposed via the hands to dichlorvos when changing cylinders during gas foggingof glasshouse or mushroom houses (Scenarios 9 & 10). The APVMA estimateddermal exposure to 0.001 mL/cylinder (equivalent to 0.0014g dichlorvos, and with30% dermal absorption, a systemic dose of 0.00042g; glove penetration, 10%).Inhalation exposure could also result if some of the dichlorvos evaporated into the1m 3 personal air space around the operator‘s breathing zone. If 0.005ml ofdichlorvos (wt. 7.1mg) was available for inhalation for 1 minute, then they wouldinhale 0.12mg or 0.0017 mg/kg b.w. (70kg) [see Appendix 2].4.11 In New Zealand, RTU gases are sold in 7 & 35L cylinders, containing 50g a.i./L;and are applied at use rates of 0.05g a.i./m 3 for volume fogging. The maximumcoverage per day is stated at 1.25ha (Scenarios 9 & 10), and assuming a 2.5mbuilding height, this would require approximately 1.6kg (31.25L of product) orfive 7L cylinders or one 35L.4.12 The fogging of glasshouses with EC dichlorvos solutions for crops or mushroomhouses (Scenarios 11 & 12) is modelled on use rates of 0.05g a.i./m 3 with amaximum coverage of 1.25ha (rate 1.25kg a.i./ha, assuming a 2.5m buildingheight) [Note: the product label also recommends use as a light spray, but Plant &Food Research reports that this is not done, and has not been modelled]. Thefogging of glasshouses for Cymbidium production (Scenarios 13 & 14) is stated tobe confined to 0.1ha per day, at a use rate of 1300 g/ha.4.13 Table V shows the modelled mixer/loader exposures and risks for the indooractivities with dichlorvos using remotely operated application equipment, withPPE and RPE (for Scenarios 9-14). The mixing loading exposure estimates forScenarios 9 & 10 were based on the APVMA approach above. For Scenarios 11-Dichlorvos reassessment – application Page 285 of 436

14, the mixing/loading component of the BBA model was used. Since the BBAmodel does not include indoor scenarios, the outdoor equivalent (hand-heldsprayer: hydraulic nozzles – outdoor, high level target) has been used for themixer/loader component.4.14 Table V also shows the modelled mixer/loader exposures and risks for the indooractivities with hand-held application equipment with dichlorvos (Scenarios 15 &16 - Cymbidium production; use rate: 1800g a.i./ha, with coverage confined to0.2ha/day) based on the BBA model, with PPE and RPE. Note the BBA modeldoes not include indoor scenarios nor application exposure for low level target, sothe outdoor equivalent (hand-held sprayer: hydraulic nozzles – outdoor, high leveltarget) has been used to estimate the operator exposures. The outdoor scenariowill tend to under estimate exposure and risk, whereas the high level target willtend to over estimate exposure and risk.4.15 Scenarios 17-25 consider applications in enclosed (industrial) spaces. Some ofthese use automatic equipment, others hand-held. In the former, occupationalexposure is confined to the mixer/loader, or in the case of gas products,connecting/disconnecting cylinders, as in the green- mushroom house scenarios.In the latter, both mixing/loading and application are included.4.16 In Scenarios 17 & 18 where RTU gas containing 50g a.i./L is triggered remotelyin enclosed spaces of 375, 3750 and 12,500 m 3 at use rates of 0.05g a.i./m 3 , 18.75,187.5 and 625g a.i. are required respectively for each space. These quantities ofactive are contained in 0.375, 3.75 and 12.5 L of gas, i.e. only one 7 L cylinderwould be needed for 375 and 3750, but two 7 L cylinders for 12,500 m 3 . Theproduct labels recommend a higher use rate of 0.15 g a.i./m 3 against certain pests.The higher rates would require 56.25, 562.5 and 975g a.i. respectively for thespaces: 375, 3750 and 12,500 m 3 . The APVMA estimated dermal exposure to0.001 mL/cylinder change (equivalent to 0.0014g dichlorvos, and with 30%dermal absorption, a systemic dose of 0.00042g; glove penetration, 10%), andinhalation exposure at 0.12 mg/cylinder change [see § 4.10 and Appendix 2]. Theresults are presented in Table VI.4.17 In Scenario 19 where RTU gas containing 50g a.i./L is applied using a manualpressure gun in enclosed spaces of 375, 3750 and 12,500 m 3 at use rates of 0.05ga.i./m 3 , the exposure calculated in § 4.15 for cylinder handling is added to thatduring application.4.18 The APVMA (2008b) noted that operators were directed to work away from spraydrift and towards the exit, and avoiding wetting any surfaces. The pressure nozzlewas likely to be held at chest or head height. Dichlorvos volatilisation would bealmost instantaneous and complete on ejection from the nozzle.4.19 The APVMA used a Pesticide Handlers Exposure Database (PHED) exposuremodel for high pressure handwand application, in the absence of any suitablePOEM model (their preferred option). The PHED model was modified to addressthe expectation that the efflux from a manual pressure gun would be significantlyless diffuse and more directional, to estimate dermal exposures during enclosedspace applications. Head/neck, exterior of clothing and hands were assumed to beDichlorvos reassessment – application Page 286 of 436

contaminated with, respectively 0.018, 2.68 and 0.26 mg/kg active handled, 10%of the values from the PHED high pressure handwand model [See Appendix 2].Without actual exposure data while using manual pressure guns, the estimatesbased on the modified PHED model must be seen as uncertain. The APVMAapproach used PPE choices of: none; overalls with 20% penetration; or, achemical resistant full-body suit that also covered the head, 5% penetration; and,gloves with 10% penetration (APVMA, 2008b). These PPE choices andpenetration factors were used in the scenarios 19-25 (see Tables VII and VIII), butonly the minimum PPE/RPE required to achieve an acceptable risk are generallytabulated.4.20 For the estimation of inhalation exposures APVMA noted, in the absence of anysuitable POEM or PHED models, that as long as the operator did not walk backthrough the efflux stream then the highest airborne concentration of dichlorvosshould be the use rate, 50 mg/m 3 , with a TWA of 25 mg/m 3 . The APVMAestimated the duration of exposure on the application times from themanufacturer‘s specification for the manual pressure gun [see Appendix 2]. Thusthe exposure times were rounded to 1.5, 15 and 50 minutes respectively. Theresults are presented in Table VI. The APVMA approach used RPE choices of:none; half-face respirator with 10% penetration; full-face respirator, 2%penetration; or, air-hose/Self-Contained Breathing Apparatus (SCBA) with 0%penetration (APVMA, 2008b). These RPE choices and penetration factors wereused in the scenarios 19-25 (see Tables VII and VIII), but only the minimumPPE/RPE required to achieve an acceptable risk are generally tabulated.4.21 In Scenarios 20 and 21 a fogging solution is triggered remotely into enclosedspaces of 375, 3750 and 12,500 m 3 . Based on a formulation containing 1000ga.i./L and applied at 5 ml/100m 3 (i.e. a use rate of 0.05g a.i./m 3 ), 18.75, 187.5 and625g a.i. are required respectively to treat each space. The product labelsrecommend a higher use rate of 0.15 g a.i./m 3 against certain pests. The higherrates would require 56.25, 562.5 and 975g a.i. respectively for the spaces: 375,3750 and 12,500 m 3 .4.22 The modelled mixer/loader exposures and risks for the indoor activities withdichlorvos were based on the BBA model, with PPE and RPE. At a use rate of0.05g a.i./m 3 and an active concentration of 1000g a.i./L, 1.25L product/ha(assuming a 2.5m building height); work rate, 0.015 ha per day for 375 m 3 , 0.15ha per day for 3750 m 3 , 0.5 ha per day for 12,500 m 3 . At the higher rate of 0.15ga.i./m 3 , the work rates are the same, but 3.75L product/ha. Note the BBA modeldoes not include indoor scenarios, so the outdoor equivalent (hand-held sprayer:hydraulic nozzles – outdoor, high level target) has been used for the mixer/loadercomponent [see Table VII].4.23 In Scenarios 22 and 23 the fogger solution is applied manually into enclosedspaces of 375, 3750 and 12,500 m 3 (equivalent areas: 150, 1500 and 2500 m 2 ;APVMA, 2008b: assumes 2.5m building height) at use rates of 0.05g a.i./m 3 . TheAPVMA considered the same Pesticide Handlers Exposure Database (PHED)exposure model for high pressure handwand application, modified to address theexpectation that the efflux from a manual pressure gun would be significantly lessdiffuse and more directional, suitable to estimate dermal exposures duringDichlorvos reassessment – application Page 287 of 436

enclosed space applications. Head/neck, exterior of clothing and hands wereassumed to be contaminated with, respectively 0.018, 2.68 and 0.26 mg/kg activehandled, 10% of the values from the PHED high pressure handwand model [seeAppendix 2]. Without actual exposure data while using high pressure handwands,the estimates based on the modified PHED model must be seen as uncertain.4.24 For inhalation exposure from manually applied fogger solutions, the sameapproach as used for estimating applicator exposures from RTU gas is used [see §4.20 and Appendix 2] [see Table VII].4.25 In Scenarios 24 and 25 where a spray is manually applied into enclosed areas of150, 1500 and 2500 m 2 (equivalent spaces: 375, 3750 and 12,500 m 3 ) at a use rateof 0.1 and 0.3g a.i./m 2 . The APVMA considered the PHED model 35(mixer/loader/applicators mixing liquid formulations by open pour methods andapplying the spraymix with high pressure handwand) the most appropriateestimation method. The predicted dermal exposure rates on head, body and handswere respectively 1.155, 90.86 and 2.49 mg a.i./kg applied. The spaces 150, 1500and 2500 m 2 would require: 15, 150 and 250g a.i. to be handled and applied at theuse rate of 0.1g a.i./m 2 . A higher application rate of 0.30g a.i./m 2 is recommendedfor the control of cockroaches, fleas etc., and the spaces would then require: 45,450 and 750g a.i. to be handled and applied. [See Appendix 3]4.26 For inhalation exposures from using high pressure handwand equipment indoors,APVMA modified the most relevant PHED model to account for the highvolatility of dichlorvos and estimated an inhalation exposure rate of 13.2 mga.i./kg applied [50 fold increase to account for the higher volatility, but also theslower volatilisation and greater droplet precipitation of an aerosol compared to aCO 2 pressure gun efflux] [See Appendix 3 and Table VIII].4.27 In Scenarios 26 and 27 RTU gas is applied manually in a domestic enclosed spaceas a surface/crevice application for the control of cockroaches, ants, fleas,silverfish, carpet beetles etc. at a use rate of 0.25g a.i./m 2 . In New Zealand theavailable product is sold in 600mL cans with 3.1g dichlorvos/L (P03653 label,BV2 Surface Insecticide). Each can contains 1.86 g dichlorvos enough for 7.44m 2at the recommended use rate above, although the label does not provide a specificapplication rate.4.28 The UK CRD (Model, 2006; Guidance document, 2008c) have models availableto estimate exposures during amateur use of pesticides, including a data-basedAerosol Surface treatment model. The model assumes rates of dermal (hand andforearm; 0.0647 mL/min; legs, feet and face: 0.0357 mL/min) and inhalationexposure per minute taken for the task (0.0006 mL/min), with a default durationof 300 seconds (5 minutes). The models rely on 15 sets of data from twoexposure monitoring studies during tasks such as spraying a small room includingsofa, 6 metres of skirting board, 2 dining chairs, and 6 m 2 of carpet. 5 minutescould seem a long time to discharge a 600mL can, but if the total time in thetreated room(s) is considered with the time needed to spray sofa cushions andmore complex items then it would be a realistic assumption. Given that there isno application rate on the label the modelling will be very approximate.Dichlorvos reassessment – application Page 288 of 436

The modelling is based upon discharge over a period of 5 minutes of a 600mLRTU can containing 3.1 g a.i/L (P03653 label, BV2 Surface Insecticide); dermalabsorption, 30%; inhalation absorption, 100%. Predicted exposures (75 thpercentile values) from Scenarios 26 and 27 with the RQ values are shown inTable IX.4.29 Scenarios 28 & 29 envisage amateur users loading a ready to use (RTU)dichlorvos spray solution into a knapsack sprayer for applications to larger areas,such as patios and decks. The registered product (P03915, BV2 SurfaceInsecticide Bulk) contains 4.4g dichlorvos/L, and is sold in 4L packs (containing17.6g a.i. in total). No application rate is recommended beyond the labelstatement that treated surfaces should be damp. This is essentially the same asScenarios 24 and 25 [§ 4.25], except for amateur instead of professional users, andwhere no PPE or RPE can be expected but smaller areas would be treated. Formodelling it is assumed that the complete 4L pack is used in one session, but theavailable models require an application rate for calculations. The professionalproducts (Scenarios 24 & 25, § 4.25) recommended application rates of 0.30ga.i./m 2 for the control of similar pests, cockroaches, fleas etc. At 0.30g a.i./m 2 , 4Lof product containing 4.4 g/L would cover approximately 60m 2 (17.6 / 0.3).Given that there is no application rate on the label the modelling will be veryapproximate.4.30 The UK CRD‘s POEM_07 (UK CRD, 2007) has models available to estimateexposures during amateur use of pesticides through knapsack sprayers (5L),which the BBA model does not, so this model was used for this application. Themodel accepts that hand contamination may be higher than for professional users.The model also requires inputs for mixing/loading. The worst-case for handcontamination during mixing / loading is posed by containers with separatemeasuring caps, and the least exposure using an "integral squeeze-to-fillmeasure". Since, the RTU product involves no measuring only loading the lowestexposure option was used. The default assumptions are that the operator uses nogloves, wears a T-shirt and shorts, and exposure lasts for 30 minutes. However,since only 4L of the RTU product is to be applied 15 minutes has been used as anupper limit for the time needed to spray 4L in place of this default setting.4.31 The exposures (75 th percentile values) from Scenarios 28 and 29 with the RQvalue are shown in Table IX.4.32 For Scenario 30, fogging of public spaces, the Nuvos label (P001132) describesthe use as covering parks, beaches, sports areas and other fly breeding sites for thecontrol of fly larvae and mosquitoes by applying a cold fog to wet the top 5-8cmof litter. The use rate is taken to be 10ml product/ 2L spraymix/ 100m 2 , based onthe area coverage advised for other applications, and as Nuvos contains 1000gdichlorvos/L this is 0.1g a.i./m 2 . For similar uses, APVMA (2008b) estimatedexposures and risks from spraying 1 or 5 ha/day.4.33 The APVMA considered the PHED model 3 (mixer/loader mixing liquidformulations by open pour methods) the most appropriate estimation method forpredicting dermal and inhalation exposures. The predicted dermal exposure rateson head, body and hands were respectively 0.0116, 0.6622 and 6.248 mg a.i./kgDichlorvos reassessment – application Page 289 of 436

handled. The APVMA considered that the predicted rate of inhalation exposurewould be significantly underestimated for dichlorvos due to its high volatility.Utilising data from one study (Gold & Holcslaw, 1984; Original not sighted), theAPVMA increased the predicted rate of inhalation exposure by 50-fold to give0.132 mg a.i./kg handled.4.34 The APVMA used the data-based PHED model 19 to predict exposures duringapplication. The predicted dermal exposure rates on head, body and hands wererespectively 0.184, 26.8 and 2.55 mg a.i./kg handled, while the predictedinhalation exposure rate was 0.174 mg a.i./kg handled. See Table X andAppendix 4 for predicted exposures from 1 hectare applications.Dichlorvos reassessment – application Page 290 of 436

Table II: Occupational Exposure Estimates & Risk Assessment aScenarios (1-4): Tractor mounted/trailed boom sprayer: hydraulic nozzlesOperation / RPE / PPEApplicationRate(kg a.i./ha)Work Rate(ha)Dermalabsorbed dose(mg/day) bInhalationabsorbed dose(mg/day) bTotal operatorsystemic exposure(mg/kg b.w./day) bRiskQuotient(RQ) cScenario 1-4: Boom sprayer with engineering controlsMixing/loading: Mechanical transfer system d(Mixing/loading: A1P2 + glovesApplication: Enclosed cab with appropriate filtration system e(Application: overalls + boots + gloves0.8 20 0.04260.11520.22780.6902Mixing/loading: A1P2 + gloves0.8 20 0.1152Application: Enclosed cab with appropriate filtration system e 0.2278Mixing/loading: Mechanical transfer system dApplication: A1P2 + hood/visor + overalls + boots + glovesScenario 1-4: Boom sprayer without engineering controlsMixing/loading: A1P2 + glovesApplication: A1P2 + hood/visor + overalls + boots + glovesMixing/loading: glovesApplication: hood/visor + overalls + boots + glovesMixing/loading: glovesApplication: glovesMixing/loading: no PPEApplication: no PPE0.8 20 0.04260.41380.8 20 0.11520.41380.8 20 0.11520.41660.8 20 0.11520.8 20 128100.00020.0002)0.00530.016)0.00020.00530.00020.00030.00020.00030.00960.0160.00960.0160.00960.016) 0.0039) 2.8) 0.00503.6)) 0.00664.7)) 0.00765.4)) 0.00805.7)) 0.116183)) 0.3048218)Dichlorvos reassessment – application Page 291 of 436

abcdeUK CRD interpretation of the German BBA Model using geometric mean estimates – a.s. concentration, 1000 g/L; dose, 0.8L product/ha; default RPE/PPE options;Assumes 30% dermal absorption for concentrate and for diluted spray; 100% inhalation absorption; 70kg body weight at application;RQ = Total Estimated Occupational Exposure (dermal mixing/loading & application, plus inhalation at mixing/loading & application per kg body weight) / AOEL whereAOEL = 0.0014 mg/kg b.w./day; RQ > 1 indicates the likelihood of an unacceptable risk to those exposed;Assumes a reduction of dermal exposures to mixer/loaders by 2.7x when only a single layer of clothes and gloves were worn (protection factor, x 0.37) [using dermalexposure data for A1P2 + gloves (0.1152) as base-line: 0.1152 x 0.37 = 0.0426];Assumes a reduction of dermal and inhalation exposures to boom-sprayer applicators by 3x when only a single layer of clothes and gloves were worn (protection factor, x0.33) [using dermal exposure data for overalls + boots + gloves (0.6902) and inhalation exposure (0.016) as base-line: 0.6902 x 0.33 = 0.2278; 0.016 x 0.33 = 0.0053].Dichlorvos reassessment – application Page 292 of 436

Table III: Occupational Exposure Estimates & Risk Assessment aScenarios (5 & 6): Tractor mounted/trailed broadcast air-assisted sprayerOperation / RPE / PPEApplicationRate(kg a.i./ha)Work Rate(ha)Dermalabsorbed dose(mg/day) bInhalationabsorbed dose(mg/day) bTotal operatorsystemic exposure(mg/kg b.w./day) bRiskQuotient(RQ) cScenario 5 & 6: Broadcast air-assisted sprayer with engineering controlsMixing/loading: Mechanical transfer system d(Mixing/loading: A1P2 + glovesApplication: Enclosed cab with appropriate filtration system e(Application: overalls + boots + gloves2.052 8 0.04370.11820.62318.3081Mixing/loading: A1P2 + gloves2.052 8 0.1182Application: Enclosed cab with appropriate filtration system e 0.6231Mixing/loading: Mechanical transfer system dApplication: A1P2 + hood/visor + overalls + boots + glovesScenario 5 & 6: Broadcast air-assisted sprayer without engineering controlsMixing/loading: A1P2 + glovesApplication: A1P2 + hood/visor + overalls + boots + glovesMixing/loading: glovesApplication: hood/visor + overalls + boots + glovesMixing/loading: glovesApplication: gloves2.052 8 0.04372.63482.052 8 0.11822.63482.052 8 0.11822.69392.052 8 0.1182530.00020.0002)0.02220.2955)0.00020.02220.00020.00590.00020.00590.00990.29550.00990.2955) 0.0098) 7) 0.0109)) 0.0384)) 0.0394)) 0.0445)) 0.7664Mixing/loading: no PPE 2.052 8 12 0.0099 ) 0.9823 702)8272832547Dichlorvos reassessment – application Page 293 of 436

Application: no PPE 57 0.2955 )abcUK CRD interpretation of the German BBA Model using geometric mean estimates – a.s. concentration, 1140 g/L; dose, 1.8L product/ha; default RPE/PPE options;Assumes 30% dermal absorption for concentrate and for diluted spray; 100% inhalation absorption; 70kg body weight at application;RQ = Total Estimated Occupational Exposure (dermal mixing/loading & application, plus inhalation at mixing/loading & application per kg body weight) / AOEL whereAOEL = 0.0014 mg/kg b.w./day; RQ > 1 indicates the likelihood of an unacceptable risk to those exposed;deAssumes a reduction of dermal exposures to mixer/loaders by 2.7x when only a single layer of clothes and gloves were worn (protection factor, x 0.37) [using dermalexposure data for A1P2 + gloves (0.1182) as base-line: 0.1182 x 0.37 = 0.0437];Assumes a reduction of dermal and inhalation exposures to air-blast applicators by 13.4x when only a single layer of clothes and gloves were worn (protection factor, x0.075) [using dermal exposure data for overalls + boots + gloves (8.3081) and inhalation exposure (0.2955) as base-line: 8.3081 x 0.075 = 0.6231; 0.2955 x 0.075 = 0.0222].Dichlorvos reassessment – application Page 294 of 436

Operation / RPE / PPETable IV: Occupational Exposure Estimates & Risk Assessment aScenarios (7 & 8): Hand-held sprayer: hydraulic nozzles. Outdoor, high level targetApplicationRate(kg a.i./ha)Work Rate(ha)Dermalabsorbed dose(mg/day) bInhalationabsorbed dose(mg/day) bTotal operatorsystemic exposure(mg/kg b.w./day) bRiskQuotient(RQ) cMixing/loading: A1P2 + glovesApplication: A1P2 + hood/visor + overalls + boots + glovesMixing/loading: glovesApplication: hood/visor + overalls + boots + glovesMixing/loading: glovesApplication: glovesMixing/loading: no PPEApplication: no PPEabc1.026 1 0.63100.47651.026 1 0.63100.49131.026 1 0.63109.20511.026 1 63120.00100.00620.05130.30780.05130.30780.05130.3078) 0.0159)) 0.0212)) 0.1457)) 1.0842UK CRD interpretation of the German BBA Model using geometric mean estimates – a.s. concentration, 1140 g/L; dose, 0.9L product/ha; default RPE/PPE options;Assumes 30% dermal absorption for concentrate and for diluted spray; 100% inhalation absorption; 70kg body weight at application;RQ = Total Estimated Occupational Exposure (dermal mixing/loading & application, plus inhalation at mixing/loading & application per kg body weight) / AOEL whereAOEL = 0.0014 mg/kg b.w./day; RQ > 1 indicates the likelihood of an unacceptable risk to those exposed;)1115104774Dichlorvos reassessment – application Page 295 of 436

Table V: Occupational Exposure Estimates & Risk AssessmentScenarios (9-16): Glass- Mushroom house ApplicationsOperation / RPE / PPEApplicationRate(kg a.i./ha)Work Rate(ha)Dermalabsorbed dose(mg/day) aInhalationabsorbed dose(mg/day) aTotal operatorsystemic exposure(mg/kg b.w./day) aRiskQuotient(RQ) bScenario 9 & 10: Glass- mushroom house fogging using RTU gas cylinders with automatic/remote application (exposure only at cylinder connection/disconnection)Scenario (9 & 10) Five 7L cylinders: Mixing/loading: gloves cMixing/loading: Air-hose/SCBA respirator + glovesScenario (9 & 10) One 35L cylinder: Mixing/loading: gloves cMixing/loading: Half-face respirator + gloves1.25 1.25 0.210.211.25 1.25 0.042Scenario 11 & 12: Glass- mushroom house fogging using EC formulations with automatic/remote application (exposure only during mixing/loading)Scenario (11 & 12) Mixing/loading: A1P2 + gloves d 1.25 1.25 0.9609 0.0016 0.0138 9.8Scenario 13 & 14: Glasshouse (Cymbidium) fogging using EC formulations with automatic/remote application (exposure only during mixing/loading)Scenario (13 & 14) Mixing/loading: A1P2 + gloves e 1.3 0.1 0.080 0.0001 0.0011 0.8Scenario 15 & 16: Glasshouse (Cymbidium) fogging using EC formulations with manual applicationScenario (15 & 16) Mixing/loading: A1P2 + gloves fApplication: A1P2 + hood/visor + overalls + boots + glovesabcd0.0421.8 0.2 0.22140.16720.6nil0.120.0120.00040.0022Assumes 30% dermal absorption for concentrate and for diluted spray; 100% inhalation absorption; 70kg body weight at application;0.01160.0030.00230.0008) 0.0056RQ = Total Estimated Occupational Exposure (dermal mixing/loading & application, plus inhalation at mixing/loading & application per kg body weight) / AOEL whereAOEL = 0.0014 mg/kg b.w./day; RQ > 1 indicates the likelihood of an unacceptable risk to those exposed;APVMA assumptions (2008): dermal exposure, 0.001 mL/cylinder change (equivalent to 0.0014g dichlorvos, and with 30% dermal absorption, a systemic dose of 0.00042g;glove penetration, 10%); inhalation exposure, 0.12 mg/cylinder change;UK CRD interpretation of the German BBA Model – geometric means: hand-held sprayer: hydraulic nozzles – outdoor, low level target; a.s. concentration, 1000 g/L; dose,)8.32.11.70.64Dichlorvos reassessment – application Page 296 of 436

1.25L product/ha; work rate, 1.25 ha per day; default RPE/PPE options;eUK CRD interpretation of the German BBA Model – geometric means: hand-held sprayer: hydraulic nozzles – outdoor, high level target; a.s. concentration, 1000 g/L; dose,1.3L product/ha; work rate, 0.1 ha per day; default RPE/PPE options;fUK CRD interpretation of the German BBA Model – geometric means: hand-held sprayer: hydraulic nozzles – outdoor, high level target; a.s. concentration, 1000 g/L; dose,1.8L product/ha; work rate, 0.2 ha per day; default RPE/PPE options.Dichlorvos reassessment – application Page 297 of 436

Table VI: Occupational Exposure Estimates & Risk AssessmentScenarios (17-19): Enclosed Space Fogging Applications with RTU GasOperation / RPE / PPEApplicationRate(g a.i./m 3 )VolumeTreated(m 3 )Dermalabsorbed dose(mg/day) aInhalationabsorbed dose(mg/day) aTotal operatorsystemic exposure(mg/kg b.w./day) aRiskQuotient(RQ) bScenario 17 & 18: Enclosed space fogging using RTU gas cylinders with automatic/remote application (exposure only at cylinder connection/disconnection)One 7L cylinder: Mixing/loading: gloves cMixing/loading: Half-face respirator + glovesTwo 7L cylinders: Mixing/loading: Half-face respirator + gloves cMixing/loading: Full-face RPE + glovesScenario 19: Enclosed space fogging using RTU gas cylinders with manual applicationMixing/loading: Half-face respirator + gloves cApplication: No PPE0.05 375, 3750 0.0420.0420.05 12,500 0.0840.05 375(1.5 minexposure,one 7Lcylinder)Mixing/loading: Half-face respirator + gloves c0.05 3750Application: Full-face RPE + chem. resistant full-body + boots +(15 mingloves dexposure,one 7LApplication: Air-hose RPE + chem. resistant full-body + boots +gloves d cylinder)Mixing/loading: Full-face respirator + gloves c0.05 12,500gloves d exposure;Application: Full-face RPE + chem. resistant full-body + boots +(50 min0.0840.0420.01670.0420.00910.00910.0840.03020.120.0120.0240.00480.0120.00890.0120.125nil0.00480.4167)0.00230.00080.00150.00131.70.61.10.9) 0.0011 0.8)) 0.0027or 0.0001)1.90.1) 0.0077 6Dichlorvos reassessment – application Page 298 of 436

Application: Air-hose RPE + chem. resistant full-body + boots +gloves dabctwo 7Lcylinders)Assumes 30% dermal absorption for concentrate and for diluted spray; 100% inhalation absorption; 70kg body weight at application;0.0302 nil or 0.0017 1.2RQ = Total Estimated Occupational Exposure (dermal mixing/loading & application, plus inhalation at mixing/loading & application per kg body weight) / AOEL whereAOEL = 0.0014 mg/kg b.w./day; RQ > 1 indicates the likelihood of an unacceptable risk to those exposed;APVMA assumptions (2008): dermal exposure, 0.001 mL/cylinder change (equivalent to 0.0014g dichlorvos, and with 30% dermal absorption, a systemic dose of 0.00042g;glove penetration, 10%); inhalation exposure, 0.12 mg/cylinder change;dP for PPE (% penetration): none, 1 (100%); overalls, 0.2 (20%); chemical resistant full-body suit, 0.05 (5%); gloves, 0.1 (10%);P for RPE (% penetration): none, 1 (100%); half-face respirator, 0.1 (10%); full-face, 0.02 (2%); air-hose/SCBA, nil exposure (0%) (Thongsinthusak et al., 1993 in APVMA,2008b).Dichlorvos reassessment – application Page 299 of 436

Table VII: Occupational Exposure Estimates & Risk AssessmentScenarios (20-23): Enclosed Space Applications with EC SolutionsOperation / RPE / PPEApplicationRate(g a.i./m 3 )VolumeTreated(m 3 )Dermalabsorbed dose(mg/day) aInhalationabsorbed dose(mg/day) aTotal operatorsystemic exposure(mg/kg b.w./day) aRiskQuotient(RQ) bScenario 20 & 21: Enclosed space fogging using EC solutions with automatic/remote application (exposure only at mixing/loading)Mixing/loading: A1P2 + gloves cMixing/loading: A1P2 + glovesMixing/loading: A1P2 + glovesMixing/loading: A1P2 + gloves dMixing/loading: A1P2 + glovesMixing/loading: A1P2 + gloves0.05 375375012,5000.15 375Scenario 22 & 23: Enclosed space fogging using EC solutions with manual applicationMixing/loading: A1P2 + gloves c375012,5000.01150.11530.38440.03460.34591.1531Application: Half-face RPE + overalls + gloves e 0.00330.05 375 0.0115Mixing/loading: A1P2 + gloves c0.05 3750 0.1153Application: Air-hose RPE + chem. resistant full-body + boots +0.0091Mixing/loading: A1P2 + gloves c0.05 12,500 0.3844Application: Air-hose RPE + chem. resistant full-body + boots +0.03020.000020.00020.00060.000060.00060.00190.000020.00090.0002nil0.0006nil0.00020.00170.00550.00050.00500.0165) 0.0002)) 0.0018)) 0.0059Mixing/loading: A1P2 + gloves d 0.15 375 0.0346 0.00006 ) 0.0007 0.5)0.11.23.90.43.690.11.34.2Dichlorvos reassessment – application Page 300 of 436

Application: Half-face RPE + overalls + gloves e 0.0099 0.0027 )Mixing/loading: A1P2 + gloves d0.15 3750 0.3459Application: Air-hose RPE + chem. resistant full-body + boots +0.02720.0006nil) 0.0053)3.8Mixing/loading: A1P2 + gloves d0.15 12,500 1.1531Application: Air-hose RPE + chem. resistant full-body + boots +0.0905abcde0.0019Assumes 30% dermal absorption for concentrate and for diluted spray; 100% inhalation absorption; 70kg body weight at application;nil) 0.0178RQ = Total Estimated Occupational Exposure (dermal mixing/loading & application, plus inhalation at mixing/loading & application per kg body weight) / AOEL whereAOEL = 0.0014 mg/kg b.w./day; RQ > 1 indicates the likelihood of an unacceptable risk to those exposed;UK CRD interpretation of the German BBA Model (mixing/loading component) – geometric means: hand-held sprayer: hydraulic nozzles – outdoor, high level target; a.s.concentration, 1000 g/L; dose, 1.25L product/ha; default RPE/PPE options;UK CRD interpretation of the German BBA Model (mixing/loading component) – geometric means: hand-held sprayer: hydraulic nozzles – outdoor, high level target; a.s.concentration, 1000 g/L; dose, 3.75L product/ha; default RPE/PPE options;APVMA modification of the PHED model for high pressure handwand application: P for PPE (% penetration): none, 1 (100%); overalls, 0.2 (20%); chemical resistant fullbodysuit, 0.05 (5%); gloves, 0.1 (10%);P for RPE (% penetration): none, 1 (100%); half-face respirator, 0.1 (10%); full-face, 0.02 (2%); air-hose/SCBA, nil exposure (0%) (Thongsinthusak et al., 1993 in APVMA,2008b).)13Dichlorvos reassessment – application Page 301 of 436

Operation / RPE / PPETable VIII: Occupational Exposure Estimates & Risk AssessmentScenarios (24-25): Enclosed Space Applications of EC Solutions with High Pressure Hand-wand aApplicationRate(g a.i./m 2 )AreaTreated(m 2 )Dermalabsorbed dose(mg/day) bInhalationabsorbed dose(mg/day) bTotal operatorsystemic exposure(mg/kg b.w./day) bRiskQuotient(RQ) cMixing/loading/Application (Dermal): Chem. resistant full-body 0.1 150 0.0218Mixing/loading/Application (Inhalation): Half-face RPE d+ boots + gloves dMixing/loading/Application (Dermal): Chem. resistant full-body 0.1 1500 0.2182Mixing/loading/Application (Inhalation): Air-hose RPE d+ boots + gloves dMixing/loading/Application (Dermal): Chem. resistant full-body 0.1 2500 0.3638Mixing/loading/Application (Inhalation): Air-hose RPE d+ boots + gloves dMixing/loading/Application (Dermal): Chem. resistant full-body 0.3 150 0.0655Mixing/loading/Application (Inhalation): Air-hose RPE d+ boots + gloves dabcd-----0.0198-nil-nil-nil) 0.0006)) 0.0031)) 0.0052)) 0.0009APVMA modifications of PHED models (mixer/loader/applicators mixing liquid formulations by open pour methods and applying the spraymix with high pressurehandwand)[Note: unlike the other models this assesses mixer/loader/applicators together, not M/L + A as above];Assumes 30% dermal absorption for concentrate and for diluted spray; 100% inhalation absorption; 70kg body weight at application;RQ = Total Estimated Occupational Exposure (dermal mixing/loading & application, plus inhalation at mixing/loading & application per kg body weight) / AOEL whereAOEL = 0.0014 mg/kg b.w./day; RQ > 1 indicates the likelihood of an unacceptable risk to those exposed;P for PPE: none, 1 (100%); overalls, 0.2 (20%); chemical resistant full-body suit, 0.05 (5%); gloves, 0.1 (10%);)0.4240.7Dichlorvos reassessment – application Page 302 of 436

P for RPE (% penetration): none, 1 (100%); half-face respirator, 0.1 (10%); full-face, 0.02 (2%); air-hose/SCBA, nil exposure (0%) (Thongsinthusak et al., 1993 in APVMA,2008b).Dichlorvos reassessment – application Page 303 of 436

Table IX: Residential Exposure Estimates & Risk AssessmentOperationApplicationRate(g a.i./m 2 )AreaTreated(m 2 )Dermalabsorbed dose(mg/day) aInhalationabsorbed dose(mg/day) aTotal operatorsystemic exposure(mg/kg b.w./day) aRiskQuotient(RQ) bScenarios (26-27): Enclosed Space Applications of RTU Gas Cans cApplication: 0.25 7.44 0.4669 0.0093 0.0068 4.9Scenarios (28-29): Surface/Crevice Applications of RTU Spray-mixes dLoading:0.3 60 0.0132nil0.1530 109Application:abcd10.6755Assumes 30% dermal absorption for concentrate and for diluted spray; 100% inhalation absorption; 70kg body weight at application;RQ = Total Estimated Occupational Exposure (dermal mixing/loading & application, plus inhalation at mixing/loading & application per kg body weight) / AOEL whereAOEL = 0.0014 mg/kg b.w./day; RQ > 1 indicates the likelihood of an unacceptable risk to those exposed;UK CRD (2006 & 2008c) models for amateur use: Aerosol Surface Treatment model – 75 th percentile values; one 600mL can containing 3.1g a.i./L; default exposure time of5 minutes; no PPE/RPE; 70kg b.w. is used instead of the default 60kg;UK CRD (2007) POEM-07 model for amateur use: Knapsack Sprayers (5L) using "integral squeeze-to-fill measure" (lowest rate of contamination as no mixing is requiredwith a RTU) – 75 th percentile values; a.s. concentration, 4.4 g/L; dose & application volume both at 683 L/ha; default exposure time of 15 minutes; no PPE/RPE; 70kg b.w.is used instead of the default 60kg.0.022Dichlorvos reassessment – application Page 304 of 436

Table X: Occupational Exposure Estimates & Risk AssessmentScenario (30): Public Space Manual Fogging Applications – 1 hectareOperation / RPE / PPEApplicationRate(g a.i./m 2 )AreaTreated(ha)Dermalabsorbed dose(mg/day) aInhalationabsorbed dose(mg/day) aTotal operatorsystemic exposure(mg/kg b.w./day) aRiskQuotient(RQ) bMixing/loading: Half-face respirator + chem. resistant full-body + 0.1 1 0.1976boots + gloves cApplication: Half-face respirator + chem. resistant full-body +boots + gloves c 0.48130.01320.0174) 0.0101)7Mixing/loading: Air-hose RPE + chem. resistant full-body +0.1 1 0.1976boots + gloves cApplication: Air-hose RPE + chem. resistant full-body + boots +gloves c 0.4813abAssumes 30% dermal absorption for concentrate and for diluted spray; 100% inhalation absorption; 70kg body weight at application;nilnil) 0.0097RQ = Total Estimated Occupational Exposure (dermal mixing/loading & application, plus inhalation at mixing/loading & application per kg body weight) / AOEL whereAOEL = 0.0014 mg/kg b.w./day; RQ > 1 indicates the likelihood of an unacceptable risk to those exposed;)7cP for PPE (% penetration): none, 1 (100%); overalls, 0.2 (20%); chemical resistant full-body suit, 0.05 (5%); gloves, 0.1 (10%);P for RPE (% penetration): none, 1 (100%); half-face respirator, 0.1 (10%); full-face, 0.02 (2%); air-hose/SCBA, nil exposure (0%) (Thongsinthusak et al., 1993 inAPVMA, 2008b).Dichlorvos reassessment – application Page 305 of 436

Conclusions on operator exposure estimates and risk assessment4.35 Scenarios 1-16 give unacceptable risks for operators (mixer/loader/applicators),even with PPE, RPE and engineering controls, where appropriate, except forScenarios (9 & 10) (automated fogging operations with RTU gas in glasshouses insome cases) and Scenarios (13 & 14) (automated fogging with EC solutions inCymbidium production, with restrictions). No outdoor uses of dichlorvos instrawberries, vegetables, cereal berries, fruit trees or passion fruit gave acceptableoperator risk estimates (Scenarios 1-8).4.36 Vegetables/Mushrooms: RTU dichlorvos gas through automatic spray systems at50 mg/m 3 may be used for the fogging of glasshouse crops/ mushrooms(Scenarios 9 & 10), provided: work day exposure is limited to the use of only onedichlorvos gas cylinder, and half-face respirator, chemical-resistant gloves,overalls, eye protection and boots are worn. Two dichlorvos gas cylinders, as amaximum, can be handled in a day (see Table VI) provided: a full-face respirator,chemical-resistant gloves, overalls, eye protection and boots are worn duringcylinder changeover. The cylinder change over restriction means that only small(approximately 0.25 ha) spaces can be treated with 7 L cylinders, but treatment oflarger spaces (up to 1.25 ha) is possible using 35L cylinders using automatedsystems.4.37 Cymbidium: EC dichlorvos solutions through automatic spray systems at 1.3kga.i./ha may be used for fogging glasshouses during Cymbidium production(Scenarios 13 & 14), provided: work day exposure is limited to 0.1ha (1,000m 2 ),and a respirator of at least A1P2 specification, eye protection and chemicalresistant gloves are worn during mixing/loading. Automated treatment or manualfine spray application at 1.8 kg a.i./ha in glasshouses for Cymbidium productiondo not give acceptable risk estimates.4.38 As can be seen from Tables VI-VIII above, some of the enclosed spaceapplications give acceptable risks for operators if adequate PPE and RPE areworn. In some cases the length of work exposure (area/volume treated) also needsto be limited.4.39 RTU dichlorvos gas through automatic spray systems at 50 mg/m 3 may be usedfor the fogging of enclosed industrial spaces of 375 or 3750 m 3 (Scenarios 17 &18; Table VI), provided: work day exposure is limited to the use of only onedichlorvos gas cylinder, and half-face respirator, chemical-resistant gloves,overalls, eye protection and boots are worn during cylinder changeover. RTUdichlorvos gas through automatic spray systems at 50 mg/m 3 may be used for thefogging of enclosed industrial spaces of 12500 m 3 (Scenarios 17 & 18), provided:work day exposure is limited to the use of only two dichlorvos gas cylinders, andfull-face respirator, chemical-resistant gloves, overalls, eye protection and bootsare worn during cylinder changeover. Thus Scenarios 17 and 18 give acceptablerisk estimates for all treatment volumes, provided sufficient PPE/RPE is worn.4.40 Application of RTU dichlorvos gas at 50 mg/m 3 may be used for the manualfogging of enclosed industrial spaces of 375 m 3 (Scenarios 19; Table VI),Dichlorvos reassessment – application Page 306 of 436

provided: work day exposure is limited to 1.5 minutes exposure, the use of onlyone dichlorvos gas cylinder, and half-face respirator and chemical-resistant glovesare worn during cylinder changeover.4.41 Application of RTU dichlorvos gas at 50 mg/m 3 may be used for the manualfogging of enclosed industrial spaces of 3750 m 3 (Scenarios 19; Table VI),provided: work day exposure is limited to 15 minutes exposure, the use of onlyone dichlorvos gas cylinder, a half-face respirator and chemical-resistant glovesare worn during cylinder changeover, and air-hose respirator or SCBA, chemicalresistantgloves, chemical-resistant full-body suit, eye protection and boots areworn during application. Thus for Scenario 19, manual treatment of largervolumes (≥3750 m 3 ) does not give acceptable estimates even with air hose RPEduring application. The risk estimate is primarily driven by the APVMA cylinderchange exposure estimates which mean that the use of two cylinders per day isunacceptable even with PPE/RPE during changeover.4.42 Mixing/loading fogging solutions at 0.05g a.i./m 3 for application throughautomatic spray systems into enclosed industrial spaces of 375 m 3 (Scenarios 20& 21; Table VII) may be done, provided: work day exposure is limited to thespecified volume, and a respirator of at least A1P2 specification, chemicalresistantgloves, overalls, eye protection and boots are worn duringmixing/loading. Mixing/loading fogging solutions at 0.15g a.i./m 3 for applicationthrough automatic spray systems into enclosed industrial spaces of 375 m 3(Scenarios 20 & 21) may be done, provided: work day exposure is limited to thespecified volume, and a respirator of at least A1P2 specification, chemicalresistantgloves, overalls, eye protection and boots are worn duringmixing/loading. Thus for Scenarios 20 & 21, only the smallest treatment volumesgive acceptable risk estimates due to the exposure during mixing/loading, but notlarger volumes (≥3750 m 3 ).4.43 Manual application of fogging solutions at 0.05 or 0.15g a.i./m 3 into enclosedindustrial spaces of 375 m 3 (Scenarios 22 & 23; Table VII), may be doneprovided: work day exposure is limited the specified volume, and half-facerespirator (at least A1P2 specification), chemical-resistant gloves, overalls, eyeprotection and boots are worn during mixing/loading and application. Thus forScenarios 22 & 23, only the smallest treatment volumes give acceptable riskestimates primarily due to the exposure during mixing/loading.4.44 The surface spraying of the smallest space 150 m 2 at 0.1g a.i./m 2 using highpressure handwand (Scenarios 24 & 25; Table VIII), may be done provided: workday exposure is limited the specified area, and a half-face respirator, chemicalresistantgloves, chemical-resistant full-body suit, eye protection and boots areworn during mixing/loading and application.4.45 The surface spraying of the smallest space 150 m 2 at 0.30g a.i./m 2 using highpressure handwand (Scenarios 24 & 25; Table VIII), may be done provided: workday exposure is limited the specified area, and air-hose respirator or SCBA,chemical-resistant gloves, chemical-resistant full-body suit, eye protection andboots are worn during mixing/loading and application. Thus for Scenarios 24 &Dichlorvos reassessment – application Page 307 of 436

25, surface spraying of larger spaces (1500 or 2500 m 2 ) at either application rategive unacceptable risk estimates primarily due to the exposure duringmixing/loading.4.46 Both the domestic uses are assumed to be carried out by amateurs without the useof PPE or RPE. Surface/crevice RTU (aerosol can) applications indoors over7.44m 2 (Scenarios 26 & 27; Table IX) and treatment of larger outdoor spaces withRTU spray-mixes using a knapsack sprayer (Scenarios 28 & 29; Table IX) arepredicted to give unacceptable risks.4.47 The public space application (Scenario 30; Table X) (for professional applicators)gives an unacceptable risk even for the treatment of only 1 hectare when wearinga chemical resistant full-body suit and air-hose RPE or SCBA.Dichlorvos reassessment – application Page 308 of 436

5POST-APPLICATION OR RE-ENTRY WORKER EXPOSURES & RISK ASSESSMENT5.1 Only a limited number of the proposed use scenarios for dichlorvos gaveacceptable risks, based on modelled estimates of exposure to operators.5.2 The routes of exposure during post-application activities are analogous to thosefor the operator, i.e. dermal and inhalation. However, the sources are different:foliage, soil and dust may contribute as treated surfaces cause pesticide residues tobe transferred to the skin.5.4 Most maintenance activities include frequent contact with the foliage of the crop.Therefore, dermal exposure is considered to be the most important exposure routeduring these re-entry activities. The amount of resulting exposure (for a certainactivity) depends on the amount of residue on foliage, the intensity of contact withthe foliage and the duration of contact.5.5 The length of time between possible applications (7 days) was long enough, giventhe dissipation rates for dichlorvos (see below), to treat the applications separatelyand not cumulatively, i.e. complete dissipation is assumed between applications 7days apart.5.6 Studies indicate that delays between application and handling can significantlyreduce the extent of dermal exposure as only about 5% of applied dichlorvosremains on the leaf surfaces after 20 minutes, while about 50% was volatilisedand 45% absorbed by the plant (Casida et al., 1962 in WHO/IPCS, 1971).5.7 Inhalation exposure may potentially occur from residual vapour and airborneaerosols. Movement of the crop may also result in inhalation exposure toaerosol/vapour as well as dust during re-entry activities.Re-entry into treated outdoor cropsDermal Exposures:Dislodgeable foliar residue (DFR)5.8 The amount of residue on foliage depends on several factors, for example, theapplication rate, targeting and retention of spray, crop type and the amount offoliage (leaf area index). Moreover, dissipation of residues on crop foliage overtime depends on the physical and chemical properties of the applied activesubstance as well as on environmental conditions. Where experimentallydetermined dislodgeable foliar residue data are not available, a worse caseassessment of the initial DFR (DFR0), in a first tier assessment, assumes 3micrograms of active substance/square centimetre of foliage/per kg a.s.applied/hectare (UK CRD, 2008a).5.9 However, some experimental data on dichlorvos is available. Only 5% of a 0.1%aqueous 32 P-dichlorvos solution remained on the leaf surfaces of maize, cottonDichlorvos reassessment – application Page 309 of 436

and peas 20 minutes after application (Casida et al., 1962; Original not sighted;APVMA, 2008b).5.10 Using the Casida et al. (1962) data a general DFR t (μg/cm 2 /kg a.i./ha) value canbe derived for dichlorvos using the equation (US EPA, 1997):DFR t = (AR x F) x (1-D) t x CF2 x CF3where:AR = application rate (kg/ha);F = fraction of a.i. retained on foliage (unitless);D = fraction of residue that dissipates daily (unitless);t = post-application day on which exposure is being assessed;CF2 = conversion factor to convert the kg a.i. in the application rate to μgfor the DFR value (1 x 10 9 μg/kg);CF3 = conversion factor to convert the surface area units (ha) in theapplication rate to cm 2 for the DFR value (1 x 10 -8 ha/cm 2 if the applicationrate is per hectare).Using Casida et al. data: 5% remains on surface at 20 mins, F = 0.05;D is not needed for these scenarios as the exposure is assumed to occur onthe day of application after residue has dried;DFR t = (1 x 0.05) x 1E9 x 1E-8 = (1 x 0.05) x 10= 0.5 μg/cm 2 per kg a.i./haTransfer coefficient (TC)5.11 The transfer of residues from the plant surface to the clothes or skin of the workercan be regarded as more or less independent of the kind of product applied and thelevel of exposure will depend on the intensity and duration of contact with thefoliage. This is also determined by the nature and duration of the activity duringre-entry. Therefore, it is possible to group various crop habitats and re-entryactivities. The EUROPOEM Group recommended indicative TC values forpotential dermal exposure for four different harvesting scenarios. For other reentryscenarios, TC data may be extrapolated where the scenarios are consideredto be comparable, i.e. the intensity and duration of contact with the foliage issimilar (UK CRD, 2008a).5.12 Three of the TC values in the European guidance documents were applicable todichlorvos use on outdoor crops: tasks in vegetable crops, 2500 cm 2 /hr; tasks infruit trees, 4500 cm 2 /hr; and, tasks in berry crops, 3000 cm 2 /hr.Predicted worker dermal exposures (D)5.13 Predicted dermal exposure for this scenario based on the UK CRD equation(modified by adding a factor for dermal absorption and dividing by the worker‘sbody weight) gives:Dichlorvos reassessment – application Page 310 of 436

D = DFR x TC x DA x WR x AR x P / BWWhere:D = Dermal Exposure [μg a.s./person*d]DFR = Dislodgeable Foliar Residue per kg a.s./haTC = Transfer Coefficient [cm²/person/h]DA = percentage dermal absorption, expressed as a fractionWR = Work RateAR = Application RateP = Penetration Factor for Clothing [= 1] which assumes one layer of ordinaryclothing is taken into accountBW = bodyweight (70 kg)5.14 In line with operator exposure estimates, 30% dermal absorption is used (SeeAppendix 5).With PPE:5.15 The BBA Model for re-entry tasks assumes a Penetration Factor (P) for PPE of0.05 (i.e. 95% protection; hood/visor + overalls over long-sleeved shirt and longleggedtrousers + boots + gloves), and this value has been used with the UK CRDbased equations.Inhalation Exposures:5.16 Predicted exposure for this scenario based on the UK CRD equation firstlydetermines the quantity of substance inhaled, then the result is modified to takeaccount of the work rate and the worker‘s body weight, in a second equation asfollows:mg a.s./hr inhaled = kg/a.s./ha applied x Task Specific FactorInhalation Exposure (I) = mg a.s./hr inhaled x WR / BWWhere:WR = Work Rate (8 hours/day)AR = Application Rate (kg/a.s./ha)BW = bodyweight (70 kg)5.17 The UK CRD model was designed for non volatile pesticides, where levels ofinhalation exposure (vapour and dust) would be expected to be low in comparisonwith dermal exposure (UK CRD, 2008a). Dichlorvos is volatile, so even withmodifications based on available data significant uncertainties will remain for theestimated inhalation exposures.Dichlorvos reassessment – application Page 311 of 436

5.18 The Task Specific Factors (TSF), suggested in the UK CRD model, are not thatappropriate for out-door activities as they were designed for the first tier of anexposure assessment relating to harvesting ornamentals and to the re-entry ofgreenhouses approximately 8-16 hours after treatment, but no better model isavailable. The indicative TSFs were 0.1 for cutting ornamentals; 0.01 for sorting& bundling ornamentals; 0.03 for re-entering greenhouses after low-volume-mistapplication; and, 0.15 for re-entering greenhouses after roof fogger application.As the tasks in these Scenarios are outside tending Berries/Fruit andVegetables/Cereals the lowest TSF 0.01 is proposed (assuming that inhalationexposure would be similar, or less, than that while bundling ornamentals indoors).5.19 Using the data from Casida et al. (1962), 20 minutes after application to the leafsurfaces of maize, cotton and peas about 50% was volatilised, while 5% remainson the leaf surfaces and 45% absorbed by the plant (in APVMA, 2008b). It isassumed therefore that only 50% of the application rate is available for possibleinhalation (See Appendix 5).Dichlorvos reassessment – application Page 312 of 436

Re-entry into out-door crops (Scenarios 1- 8)Scenario:Table XII: Re-Entry Worker Exposure Estimates & Risk Assessment – Scenarios 1 - 8: Out-door CropsApplication Rate(AR)[kg a.s./ha]Modified Model with or without PPE aTransferCoefficient(TC)[cm²/person/h]Dermal/InhalationExposureswithout PPE/RPE[μg a.s./kg b.w./d]1 & 2 Berries e reaching, picking 0.8 3000 D = 41 b3a & 4a Vegetablesereaching, picking 0.8 2500 D = 34 bRisk Quotient(RQ) withoutPPE/RPE dDermal/InhalationExposures withPPE/RPE[μg a.s./kg b.w./d]I = 0.46 c 30 2.06I = 0.463b & 4b Cereals e Scouting 0.8 1500 D = 21 bI = 0.463c & 4c Berries e reaching, picking 0.8 3000 D = 41 b5 & 6 Fruit e searching,reaching, picking7 & 8 Fruit e searching,reaching, pickingFootnotes below2.052 4500 D = 158 b1.026 4500 D = 79 b0.009225 1.710.0092Risk Quotient withPPE/RPEd1.51.215 1.030.046 f 0.8I = 0.46 c 30 2.06nil g 1.5I = 1.17 c 114 7.90.023I = 1.17 c 57 3.960.02363Dichlorvos reassessment – application Page 313 of 436

abcdefgUK CRD Guidance for Post-Application (Re-Entry Worker) Exposure Assessment (UK CRD, 2008a), with cereals TC from US EPA (US EPA, 2000);D (dermal exposure) = DFR x TC x DA x WR x AR x P / BWWhere: DFR = 0.5 μg a.s./cm² per kg a.s./ha (Casida et al., 1962 in APVMA, 2008b);DA = percentage dermal absorption (30%); BW = bodyweight (70 kg); WR = 8 hours/dayP = Penetration Factor for Clothing [= 1 which assumes one layer of ordinary clothing is taken into account; or 0.05 for PPE: hood/visor + overalls over long-sleevedshirt and long-legged trousers + boots + gloves]I (inhalation exposure) = mg a.s./hr inhaled x WR / BWWhere: mg a.s./hr inhaled = kg/a.s./ha applied x Task Specific Factor; 50% volatilisation assumed (Casida et al., 1962 in APVMA, 2008b);Task Specific Factor: Berries/Fruit, Vegetables/Cereals, 0.01;P for RPE (% penetration): none, 1 (100%); half-face respirator, 0.1 (10%); full-face, 0.02 (2%); air-hose/SCBA, nil exposure (0%) – RPE is full-face respirator unlessotherwise stated (Thongsinthusak et al., 1993 in APVMA, 2008b);RQ = Total Estimated Occupational Exposure / AOEL where AOEL = 1.4 μg/kg b.w./day RQ > 1 indicates the likelihood of an unacceptable risk to those exposed;Assumes 1 or 2 treatments per year (7 days between applications), with complete dissipation between repeat applications;Half-face respirator;Air-hose/SCBA (Scenarios 1 & 2 RQs would also be unacceptable with Air-hose/SCBA).Dichlorvos reassessment – application Page 314 of 436

Re-entry into treated glasshouses during crop production (Scenarios 9-12)5.22 Dichlorvos residues on surface and in the air after indoor application areinfluenced by environmental parameters, such as the rate of air exchange,temperature and the amount of sunlight penetration. Deposited dichlorvos may bedegraded, adsorbed or re-enter the atmosphere (Brouwer et al., 1992 in APVMA,2008b). Rapid degradation can occur on concrete or glass, whereas wood may actas a reservoir (Hussey & Hughes, 1963 in APVMA, 2008b).5.23 The APVMA reported results from two studies carried out in a glasshouse mistedat 33 mg dichlorvos/m 3 , where the dissipation kinetics in the 2 experimentsshowed considerable variation, especially after the first 240 minutes postapplication(Brouwer et al., 1992 in APVMA, 2008b).5.24 In the first study the glasshouse was unventilated and there was a narrowtemperature range (11.6 – 14ºC), and gave the slowest dissipation. Airbornedichlorvos levels declined progressively from 8860 to 715 μg/m 3 over 6 hours.When regression analysis of Log 10 concentration vs time was performed, the Yintercept was 3.84 (or log [6900] μg/m 3 ) and the slope [the rate of loss ofdichlorvos] was -0.0031/min.5.25 In the second study the glasshouse was ventilated after 360 minutes. Airbornedichlorvos levels fell from 9910 to 875 μg/m 3 over 240 minutes. When regressionanalysis of Log 10 concentration vs time was performed, the Y intercept was 3.84(or log [6900] μg/m 3 ) and the slope was -0.0043/min. After 240 minutes thetemperature increased from 12 to 24ºC, and the dichlorvos concentrationincreased to 1000 μg/m 3 . The slope of the post-ventilation Log 10 concentration vstime plot was -0.018/min, faster than either of the pre-ventilation rate losses.REI for workers ventilating the glasshouse after treatment:5.26 As the New Zealand use rate in glasshouses is 50 mg dichlorvos/m 3 for crops (notflowers) the application rate will be approximately 1.5 times the rate used in theBrouwer et al. study. The regression plot intercept is adjusted upwards to 4.02(Log 10 [6900 x 1.515]) while the same slope (-0.0031/min) has been assumed.This is the approach and slope used by APVMA in their assessment forventilating the greenhouse (2008b).5.27 Taking the slowest initial decline in dichlorvos levels from the two studies, theairborne concentration of dichlorvos at 240 minutes will be:10 (4.02 + [-0.0031 x 240]) = 1888 μg/m 35.28 Re-entering the treated glasshouse to ventilate it would expose the worker byinhalation at approximately 1.89 mg/m 3 . If the duration of exposure was 30minutes, the worst-case upper limit, the inhalation exposures with various RPEwould be the values set out in Table XIII:Dichlorvos reassessment – application Page 315 of 436

Table XIII: Re-entry into glasshouses treated at 50 mg dichlorvos/m 3 – inhalation exposure atventing (240 minutes after application)Airbornedichlorvosconc.(mg/m 3 )Duration (h)Exposure(mg) aDose (mg/kg b.w.) bRespiratory protection cNone Half-face Full-face Air-hose1.89 0.5 0.95 0.0136 0.0014 0.0003 NilabcInhalation rate, 1 m 3 /hour;Body weight, 70kg;Protection factors from APVMA, 2008b: factor of 0.1 for a half face mask and a factor of 0.02 for afull face mask respectively, and no exposure for air-hose (supplied air system) [results rounded].5.29 Predicted dermal exposure for this scenario when using PPE (hood/visor +overalls over long-sleeved shirt and long-legged trousers + boots + gloves) basedon the UK CRD equation (by adding a factor for dermal exposure and dividing bythe worker‘s body weight) gives:D = DFR x TC x DA x WR x AR x P / BWD = 0.5 x 2500 x 0.3 x 0.5 x 1.25 x 0.05 / 70 =11.7188 / 70 = 0.1674 μg a.s./kg b.w./dayChanging the units and rounding the dermal exposure with PPE is 0.0002mga.s./kg bw/day.Where:D = Dermal Exposure [μg a.s./person*d]DFR = Dislodgeable Foliar Residue per kg a.s./ha = 0.5 μg a.s./cm² per kg a.s./ha[Note: a DFR based on the Casida et al. (1962) data is used, showing only 5% ofapplied active available for skin contamination 20 minutes after application; seeSections 5.9 & 5.10]:TC = Transfer Coefficient [cm²/person/h] [the lowest TC was Vegetables – 2500(UK CRD); ventilating the building should result in less transfer]DA = percentage dermal absorption [30%], expressed as a fraction.WR = Work Rate [0.5 hours/day]AR = Application Rate [1.25 kg a.s./ha; assumes 2.5m building height]P = Penetration Factor for Clothing [= 0.05] German BBA Model for re-entrytasks that assumes a Penetration Factor (P) for PPE of 0.05 (i.e. 95% protection)hood/visor + overalls over long-sleeved shirt and long-legged trousers + boots +glovesBW = bodyweight [70 kg]5.30 Predicted total exposures and risk assessments indicate that re-entry to treatedglass-houses for the purpose of venting (taking 30 minutes or less) may beDichlorvos reassessment – application Page 316 of 436

acceptable 240 minutes after application if PPE (hood/visor + overalls over longsleevedshirt and long-legged trousers + boots + gloves) and RPE (full-face or airhose)are used. See Table XIV:Table XIV: Re-entry into glasshouses treated at 50 mg dichlorvos/m 3 – total exposure and risksat venting: 30 minutes exposure (4 hours after application)Dose (mg/kg b.w.) aRespiratory protection bNone Half-face Full-face Air-hoseInhalation 0.0136 0.0014 0.0003 NilDermal (with PPE as above) 0.0002 0.0002 0.0002 0.0002Total 0.0138 0.0016 0.0005 0.0002Risk Quotient (RQ) c 9.9 d 1.1 d 0.4 0.1abBody weight, 70kg;Protection factors from APVMA, 2008b: factor of 0.1 for a half face mask and a factor of 0.2 for afull face mask respectively, and no exposure for air-hose (supplied air system) [results rounded];cRQ = Total Estimated Occupational Exposure / AOEL where AOEL = 0.0014 mg/kg b.w./day;dRQ > 1 indicates the likelihood of an unacceptable risk to those exposed.REI for workers re-entering and working in a glasshouse for vegetable production:5.31 The second Brouwer et al. study where the glasshouse was ventilated after 360minutes (see 5.25) indicated a faster rate of dissipation of air concentrations onceventilation had started. No further data are available on the reduction in DFR,other than the information of Casida et al. (1962), so it is assumed that beyond 20minutes after treatment, no further dissipation from plant surfaces occurs. Bycalculating a systemic dose from dermal exposure, the residual portion of theAOEL may be used to derive a REI when the workplace atmosphericconcentration of dichlorvos has dropped low enough to allow an 8-hour work-day.5.32 The UK CRD equation for dermal exposure with TC for Berries (3000) and PPE,(hood/visor + overalls over long-sleeved shirt and long-legged trousers + boots +gloves) indicates:D = DFR x TC x % absorbed x WR x AR x P / BWD = 0.5 x 3000 x 0.3 x 8 x 1.25 x 0.05 / 70 =225 / 70 = 3.214 μg a.s./kg b.w./day5.33 In this instance the estimated dermal exposure is 3.214 μg a.s./kg b.w./day(0.0032 mg/kg bw/day) which exceeds the AOEL (1.4 μg/kg b.w./day) with a RQ= 2.3, before any contribution from inhalation has been considered.Dichlorvos reassessment – application Page 317 of 436

5.34 No REI for treated glasshouses and similar crop production facilities can be setfor an 8-hour working day, based on the available information.5.35 If working access to the treated building is limited to only 2 hours per day, thenestimated dermal exposure with PPE reduces to 0.804 μg a.s./kg b.w./day, andinhalation exposure can be estimated.5.36 The remaining AOEL, assuming re-entry workers have not been exposed todichlorvos during other tasks, (1.4 - 0.804 = 0.596 μg a.s./kg b.w./day) may beassigned to inhalation exposures at a respiration rate of 1 m 3 /hour (APVMA,2008b). To convert the exposure limit by body weight to an atmospheric level:Inhalation exposure limit (μg a.s./kg b.w./day) x Body wt (kg)Respiration volume (contaminated) (m 3 /hour) x Working day (hours)(0.596 x 70) / (1 x 2) = 21 μg/m 3[Note: Working day is reduced to 2 hours from the default 8.]5.37 In the second Brouwer et al. study where the glasshouse was ventilated, the slopeof the post-ventilation Log 10 concentration vs time plot was -0.018/min. Thisregression line may be used to estimate a REI for glasshouses treated at 50 mg/m 3 ,from:-{((Log 10 (Initial concentration) – Log 10 (Final concentration)) ÷ slope.}5.38 If the dichlorvos concentration at the start of ventilation is 1888 μg/m 3 and theslope is -0.018/min, then the time taken for the concentration to decline to 21μg/m 3 will be (3.276 – 1.322) ÷ 0.018 = 109 minutes or 1.8 hours. This assumesno RPE is used, but PPE is used.5.39 If re-entry activities could be limited to 2 hours with the use of PPE (hat + goggles+ overalls over long-sleeved shirt and long-legged trousers + boots + gloves), aREI for treated glasshouses and similar plant production facilities could be set at 4hours after the onset of ventilation, allowing for environmental variation betweendifferent structures. Hat and goggles are specified instead of the hood and visorused in the exposure modelling, as they would seem to be more practical whileoffering adequate protection.[Note: The P005877 Armour-Crop label gives a WithHolding Period (WHP) ofthree days for green-house capsicum; P001132 Nuvos label gives a WHP of 3days for ―other fruit and vegetables‖.]Dichlorvos reassessment – application Page 318 of 436

Re-entry into treated glasshouses used for Cymbidium production (Scenarios 13-16)REI for workers ventilating the glasshouse after treatment for Cymbidium production:5.40 The New Zealand use rates in glasshouses for flower production are 52 and 72 mgdichlorvos/m 3 [The use rates are quoted as 1300g a.i./ha for a maximum of 0.1haor 2500m 3 i.e. 1300 / 25000 = 52 mg/m 3 , assuming a 2.5m building height; and1800g a.i./ha for a maximum of 0.2ha or 5000m 3 i.e. 1800 / 25000 = 72 mg/m 3 ].These application rates are approximately 1.58 and 2.18 times the rate (33 mg/m 3 )used in the Brouwer et al. study without ventilation. The regression plotintercepts are adjusted upwards to 4.04 (Log 10 [6900 x 1.58]) and 4.18 (Log 10[6900 x 2.18]) while the same slope (-0.0031/min) has been assumed.5.41 Taking the slowest initial decline in dichlorvos levels, the airborne concentrationof dichlorvos at 240 minutes will be:At 52 mg dichlorvos/m 3 : 10 (4.04 + [-0.0031 x 240]) = 1977 μg/m 3At 72 mg dichlorvos/m 3 : 10 (4.18 + [-0.0031 x 240]) = 2729 μg/m 35.42 Re-entering the treated glasshouse to ventilate it would expose the worker byinhalation at approximately 1.98 or 2.73 mg/m 3 . If the duration of exposure was30 minutes, the worst-case upper limit, the inhalation exposures with various RPEwould be, Table XV:Table XV: Re-entry into glasshouses treated at 52 or 72 mg dichlorvos/m 3 – inhalation exposureat venting (240 minutes after application)Airbornedichlorvosconc.(mg/m 3 )Duration (h)Exposure(mg) aDose (mg/kg b.w.) bRespiratory protection cNone Half-face Full-face Air-hose1.98 0.5 0.99 0.014 0.001 0.0003 Nil2.73 0.5 1.37 0.020 0.002 0.0004 NilabcInhalation rate, 1 m 3 /hour;Body weight, 70kg;Protection factors from APVMA, 2008b: factor of 0.1 for a half face mask and a factor of 0.2 for afull face mask respectively, and no exposure for air-hose (supplied air system) [results rounded].5.43 Predicted dermal exposure for these scenarios when using PPE (hood/visor +overalls over long-sleeved shirt and long-legged trousers + boots + gloves) basedon the UK CRD equation (by adding a factor for dermal exposure and dividing bythe worker‘s body weight) gives:At 52 mg dichlorvos/m 3 (1300g a.i./ha):D = DFR x TC x DA x WR x AR x P / BWD = 0.5 x 5000 x 0.3 x 0.5 x 1.3 x 0.05 / 70 = 24.375 / 70 = 0.348 μg a.s./kg b.w./dayDichlorvos reassessment – application Page 319 of 436

At 72 mg dichlorvos/m 3 (1800g a.i./ha):D = 0.5 x 5000 x 0.3 x 0.5 x 1.8 x 0.05 / 70 = 33.75 / 70 = 0.482 μg a.s./kg b.w./dayWhere:D = Dermal Exposure [μg a.s./person*d]DFR = Dislodgeable Foliar Residue per kg a.s./ha = 0.5 μg a.s./cm² per kg a.s./ha[Note: a DFR based on the Casida et al. (1962) data is used, showing only 5% ofapplied active available for skin contamination 20 minutes after application; seeSections 5.9 & 5.10]TC = Transfer Coefficient [cm²/person/h] [e.g. Ornamentals - Cut / Sort / Bundle /Carry - 5000 (UK CRD)]DA = percentage dermal absorption [30%], expressed as a fractionWR = Work Rate [0.5 hours/day]AR = Application Rate [1.3 or 1.8 kg a.s./ha]P = Penetration Factor for Clothing [= 0.05] German BBA Model for re-entrytasks that assumes a Penetration Factor (P) for PPE of 0.05 (i.e. 95% protection)hood/visor + overalls over long-sleeved shirt and long-legged trousers + boots +glovesBW = bodyweight [70 kg]5.44 Predicted total exposures and risk assessments indicate that re-entry to treatedglasshouses for the purpose of venting (taking 30 minutes or less) may beacceptable 4 hours after application if PPE (hood/visor + overalls over longsleevedshirt and long-legged trousers + boots + gloves) and RPE (full-face or airhose)are used. See Tables XVI and XVII:Table XVI: Re-entry into glasshouses treated at 52 mg dichlorvos/m 3 – total exposure and risksat venting: 30 minutes exposure (240 minutes after application)Dose (mg/kg b.w.) aRespiratory protection bNone Half-face Full-face Air-hoseInhalation 0.014 0.001 0.0003 NilDermal (with PPE above) 0.0003 0.0003 0.0003 0.0003Total 0.0143 0.0013 0.0006 0.0003Risk Quotient (RQ) c 10 d 0.9 0.4 0.2abBody weight, 70kg;Protection factors from APVMA, 2008b: factor of 0.1 for a half face mask and a factor of 0.02 for afull face mask respectively, and no exposure for air-hose (supplied air system) [results rounded];cdRQ = Total Estimated Occupational Exposure / AOEL where AOEL = 0.0014 mg/kg b.w./day;RQ > 1 indicates the likelihood of an unacceptable risk to those exposed.Dichlorvos reassessment – application Page 320 of 436

Table XVII: Re-entry into glasshouses treated at 72 mg dichlorvos/m 3 – total exposure and risksat venting: 30 minutes exposure (240 minutes after application)Dose (mg/kg b.w.) aRespiratory protection bNone Half-face Full-face Air-hoseInhalation 0.025 0.003 0.0005 NilDermal (with PPE) 0.0005 0.0005 0.0005 0.0005Total 0.0255 0.0035 0.0010 0.0005Risk Quotient (RQ) c 18 d 2.5 d 0.7 0.4abBody weight, 70kg;Protection factors from APVMA, 2008b: factor of 0.1 for a half face mask and a factor of 0.02 for afull face mask respectively, and no exposure for air-hose (supplied air system) [results rounded];cRQ = Total Estimated Occupational Exposure / AOEL where AOEL = 0.0014 mg/kg b.w./day;dRQ > 1 indicates the likelihood of an unacceptable risk to those exposed.REI for workers re-entering and working in a glasshouse for Cymbidium production:5.45 The second Brouwer et al. study (see 5.25) where the glasshouse was ventilatedafter 360 minutes indicated a faster rate of dissipation of air concentrations onceventilation had started. No further data are available on the reduction in DFR,other than the information of Casida et al. (1962), so it is assumed that beyond 20minutes after treatment, no further dissipation from plant surfaces occurs. Bycalculating a systemic dose from dermal exposure, the residual portion of theAOEL may be used to find a REI when the workplace atmospheric concentrationof dichlorvos has dropped low enough to allow an 8-hour work-day.The UK CRD equation for dermal exposure with TC for Ornamentals - Cut / Sort/ Bundle / Carry - 5000 and PPE, (hood/visor + overalls over long-sleeved shirtand long-legged trousers + boots + gloves) indicates:At 52 mg dichlorvos/m 3 :D = DFR x TC x DA x WR x AR x P / BWD = 0.5 x 5000 x 0.3 x 8 x 1.3 x 0.05 / 70 = 390 / 70 = 5.57 μg a.s./kg b.w./dayAt 72 mg dichlorvos/m 3 :D = 0.5 x 5000 x 0.3 x 8 x 1.8 x 0.05 / 70 = 540 / 70 = 7.71 μg a.s./kg b.w./day[Equation parameters are as discussed in 5.43, with appropriate modifications:WR = Work Rate [8 hours/day].]Dichlorvos reassessment – application Page 321 of 436

5.46 In this instance, after treatment with 52 mg/m 3 (1300g a.i./ha) the estimateddermal exposure is 5.57 μg a.s./kg b.w./day and exceeds the AOEL (1.4 μg/kgb.w./day) with a RQ = 4, before any contribution from inhalation has beenconsidered.5.47 After treatment with 72 mg/m 3 (1800g a.i./ha) the estimated dermal exposure is7.71 μg a.s./kg b.w./day and exceeds the AOEL (1.4 μg/kg b.w./day) with a RQ =6, before any contribution from inhalation has been considered.5.48 No REI for treated glasshouses used for Cymbidium production can be set for an8-hour work day, based on the available information.5.49 If working access to glasshouses and similar Cymbidium production facilitiestreated at the lowest use rate (52 mg/m 3 ; 1300g a.i./ha) is limited to only 1 hourper day, then estimated dermal exposure with PPE reduces to 0.696 μg a.s./kgb.w./day, and inhalation exposure can be estimated.5.50 The remaining AOEL, assuming re-entry workers have not been exposed todichlorvos during other tasks, (1.4 - 0.696 = 0.704 μg a.s./kg b.w./day) may beassigned to inhalation exposures at a respiration rate of 1 m 3 /hour (APVMA,2008b). To convert the exposure limit by body weight to an atmospheric level:Inhalation exposure limit (μg a.s./kg b.w./day) x Body wt (kg)Respiration volume (contaminated) (m 3 /hour) x Working day (hours)At 52 mg dichlorvos/m 3 (1300g a.i./ha):(0.704 x 70) /( 1 x 1) = 49.28 μg/m 3[Note: Working day is reduced to 1 hour from the default 8.]5.51 In the second Brouwer et al. study where the glasshouse was ventilated, the slopeof the post-ventilation Log 10 concentration vs time plot was -0.018/min. Thisregression line may be used to estimate a REI for glasshouses treated at 52 mg/m 3 ,from:((Log 10 (Initial concentration) – Log 10 (Final concentration)) ÷ slope.5.52 If the dichlorvos concentration at the start of ventilation is 2432 μg/m 3 aftertreatment at 52 mg/m 3 and the slope is -0.018/min, then the time taken for theconcentration to decline to 49.28 μg/m 3 will be (3.386 – 1.693) ÷ 0.018 = 94minutes or 1.6 hours. This assumes no RPE was used, but PPE was used.5.53 If re-entry activities could be limited to 1 hour with the use of PPE (hat + goggles+ overalls over long-sleeved shirt and long-legged trousers + boots + gloves), aREI for glasshouses and similar Cymbidium production facilities treated at theDichlorvos reassessment – application Page 322 of 436

lowest use rate (52 mg/m 3 ; 1300g a.i./ha) could be set at 4 hours after the onset ofventilation, allowing for environmental variation between different structures.Dichlorvos reassessment – application Page 323 of 436

Re-entry into treated mushroom houses (Scenarios 9-12)5.54 The Brouwer et al. (1992) data for a sunlit glasshouse of metal, glass and concretemay not be relevant for a dark mushroom house built with wood. The APVMAreported results from studies carried out in a closed and unventilated mushroomhouse sprayed at 212 mg/m 3 (Hussey & Hughes, 1963 in APVMA, 2008b). Thehalf-life of airborne dichlorvos over the first 2.5 hours was about 20 minutes,while the dissipation rate slowed over the period 6.5-17 hours with a half-life ofabout 7 hours (APVMA, 2008b). When regression analysis of Log 10concentration vs time was performed on the second slower phase, the Y intercept(at t=0) was 1.358 mg/m 3 and the slope was -0.0558/hour.5.55 Acknowledging that the approach was based on little information, the APVMAbased their estimates of re-entry exposures on unventilated mushroom houses.Their information was that most of the off-label use was carried out on spawningrooms after being filled and sealed. The spawning rooms would then remainedunder controlled atmosphere for 10 days undisturbed (APVMA, 2008b).5.56 As the New Zealand use rate in mushroom houses is 50 mg dichlorvos/m 3 theapplication rate will be 23.6% of the rate used in the Hussey & Hughes study.The regression plot intercept is adjusted downwards to -0.494 (Log 10 [1.358 x0.236 = 0.321 mg/m 3 ]) while the slope (-0.0558/hour) is assumed.5.57 No further data on plants are available on the reduction in DFR, other than theinformation of Casida et al. (1962), so it is assumed that beyond 20 minutes aftertreatment, no further dissipation from plant surfaces occurs. However, dichlorvosexhibits more persistence on wood, with 65% of the applied dose remaining after7 hours and 45-55% between days 2-18 (Hussey & Hughes, 1964; in APVMA,2008b). So, the use of the Casida et al. data does contribute some uncertainty inthe absence of more relevant information.5.58 By calculating a systemic dose from dermal exposure, the residual portion of theAOEL may be used to find a REI when the workplace atmospheric concentrationof dichlorvos has dropped low enough to allow an 8-hour work-day.5.59 The predicted dermal exposure for this scenario when using PPE (hood/visor +overalls over long-sleeved shirt and long-legged trousers + boots + gloves) isbased on the UK CRD equation (by adding a factor for dermal exposure anddividing by the worker‘s body weight) and gives:D = DFR x TC x DA x WR x AR x P / BWD = 0.5 x 2500 x 0.3 x 8 x 1.25 x 0.05 / 70 = 187.5 / 70 = 2.679 μg a.s./kg b.w./day(RQ = 1.9)Where:D = Dermal Exposure [μg a.s./person*d]DFR = Dislodgeable Foliar Residue per kg a.s./ha = 0.5 μg a.s./cm² per kg a.s./haTC = Transfer Coefficient [cm²/person/h] [e.g. Vegetables – Reach/Pick – 2500(UK CRD)Dichlorvos reassessment – application Page 324 of 436

DA = percentage dermal absorption [30%], expressed as a fractionWR = Work Rate [8 hours/day]AR = Application Rate [1.25 kg a.s./ha]P = Penetration Factor for Clothing [= 0.05] German BBA Model for re-entrytasks that assumes a Penetration Factor (P) for PPE of 0.05 (i.e. 95% protection)hood/visor + overalls over long-sleeved shirt and long-legged trousers + boots +glovesBW = bodyweight [70 kg]5.60 After treatment with 50 mg/m 3 the estimated dermal exposure is 2.679 μg a.s./kgb.w./day and exceeds the AOEL (1.4 μg/kg b.w./day) with a RQ = 1.9, before anycontribution from inhalation has been considered.5.61 No REI for treated mushroom houses can be set for an 8-hour work day, based onthe available information.5.62 If working access to mushroom houses is limited to only 2 hours per day, thenestimated dermal exposure with PPE reduces to 0.67 μg a.s./kg b.w./day, andinhalation exposure can be estimated.5.63 The remaining AOEL, assuming re-entry workers have not been exposed todichlorvos during other tasks, (1.4 - 0.67 = 0.73 μg a.s./kg b.w./day) may beassigned to inhalation exposures at a respiration rate of 1 m 3 /hour (APVMA,2008b). To convert the exposure limit by body weight to an atmospheric level:Inhalation exposure limit (μg a.s./kg b.w./day) x Body wt (kg)Respiration volume (contaminated) (m 3 /hour) x Working day (hours)(0.73 x 70) /( 1 x 2) = 26 μg/m 3[Note: Working day is reduced to 2 hours from the default 8.]5.64 In Hussey & Hughes study the slope of the slower second phase of dissipationLog 10 concentration vs time plot was -0.0558/hour. This regression line may beused to estimate a REI for mushroom houses treated at 50 mg/m 3 , from (Log 10Initial concentration – Log 10 Final concentration) ÷ slope.5.65 If the dichlorvos concentration at the start is 0.321 mg/m 3 and the slope is -0.0558/hour, then the time taken for the concentration to decline to 0.026 mg/m 3will be (-0.494 – [-1.585]) ÷ 0.0558 = 20 hours. This assumes no RPE is used.5.66 If re-entry activities could be limited to 2 hours with the use of PPE (hat + goggles+ overalls over long-sleeved shirt and long-legged trousers + boots + gloves), aREI for mushroom houses treated at 50 mg/m 3 could be set at 48 hours aftertreatment, allowing for environmental variation between different structures.Dichlorvos reassessment – application Page 325 of 436

[Note: P001132 Nuvos label gives a WHP of 3 days for ―other fruit andvegetables‖.]Dichlorvos reassessment – application Page 326 of 436

Re-entry into treated enclosed industrial spaces (Scenarios 17-23)5.67 The APVMA used a study by Schofield (1993; Original not sighted) for data ondichlorvos behaviour after fogging industrial buildings (APVMA, 2008b). Thestudy was carried out in a large industrial building fogged to a targetconcentration of 85 mg/m 3 . The airborne dichlorvos levels were measured for 6hours, and then the building was ventilated for one hour before the workforce reentered.The half-life of airborne dichlorvos over the first dissipation phase was1.6 hours. The author‘s regression analysis of L n concentration vs time gave theY intercept at 2.996 (or ln [20] mg/m 3 ) and the slope [the rate of loss ofdichlorvos] was -0.4207/hour. [Schofield‘s analysis expressed the result innatural logarithms.] Schofield‘s data indicated that the dissipation half-life ofdichlorvos after ventilation slowed to 12.7 hours. [TCL notes the finding isunexpected.] The regression analysis of L n concentration vs time gave the slope[the rate of loss of dichlorvos] as -0.0544/hour. The R 2 of the second phaseanalysis was 0.74 (first phase, 0.98) indicating considerably more variability anduncertainty in the latter values, which may explain the finding.5.68 The APVMA (2008b) noted that, based on Schofield‘s data, after an applicationof RTU gas at the Australian label rate of 33 mg/m 3 into industrial buildings atoxicologically unacceptable level of dichlorvos would persist for 3 days, but aREI of 4 days could be supportable. However, as the New Zealand use rate is 50mg/m 3 , even a 4-day REI may not be supported. Risks for the New Zealandapplication rate are estimated further below (see Tables XVIII & XIX).5.69 It should be noted that product labels (Nuvos, P001132; Divap, P006080)recommend that treated enclosed spaces should be kept closed for 10-12 hoursbefore ventilation, and another 10-12 hours should elapse before recommencingwork in the buildings.REI for workers ventilating industrial buildings after treatment at 50 mg/m 3 :5.70 As the main New Zealand use rate is 50 mg dichlorvos/m 3 for industrial buildingsthe application rate will be approximately 59% the rate used in the Schofieldstudy. The regression plot intercept is adjusted downwards to 2.465 (L n [20 x0.588]) while the same slope (-0.4207/h) has been assumed. [Schofield‘s analysisexpressed the result in natural logarithms.]5.71 Taking the initial decline in dichlorvos levels, the airborne concentration ofdichlorvos at 10 hours will be:e (2.465 + [-0.4207 x 10]) = 0.175 mg/m 35.72 Re-entering the treated building to ventilate it would expose the worker byinhalation at approximately 0.175 mg/m 3 . If the duration of exposure was 30minutes, the worst-case upper limit, the inhalation exposures with various RPEwould be the values set out in Table XVIII:Dichlorvos reassessment – application Page 327 of 436

Table XVIII: Re-entry into buildings treated at 50 mg dichlorvos/m 3 – inhalation exposure atventing (10 hours after application)Airbornedichlorvosconc.(mg/m 3 )Duration (h)Exposure(mg) aDose (mg/kg b.w.) bRespiratory protection cNone Half-face Full-face Air-hose0.175 0.5 0.09 0.0013 0.0001

nature of the building itself, not the form in which the dichlorvos is applied (gas,fogging solution or aerosol).REI for workers ventilating industrial buildings after treatment at 150 mg/m 3 :5.76 Buildings can also be treated at a higher rate, 150 mg dichlorvos/m 3 , forcockroaches, fleas etc. (P001132 Nuvos label) (Scenarios 17-23, 24 & 25)(TableXIX):L n Initial concentration [20 x 1.7647] = 35.29e (3.5636 + [-0.4207 x 10]) = 0.526 mg/m 3Table XIX: Re-entry into buildings treated at 150 mg dichlorvos/m 3 – inhalation exposure atventing (10 hours after application)Airbornedichlorvosconc.(mg/m 3 )Duration (h)Exposure(mg) aDose (mg/kg b.w.) bRespiratory protection cNone Half-face Full-face Air-hose0.526 0.5 0.263 0.0038 0.0004 0.0001 NilabcRisk Quotient (RQ) d 2.7 e 0.3 0.07 -Inhalation rate, 1 m 3 /hour;Body weight, 70kg;Protection factors from APVMA, 2008b: factor of 0.1 for a half face mask and a factor of 0.02 for afull face mask respectively, and no exposure for air-hose (supplied air system) [results rounded];dRQ = Total Estimated Occupational Exposure / AOEL where AOEL = 0.0014 mg/kg b.w./day;eRQ > 1 indicates the likelihood of an unacceptable risk to those exposed.5.77 Therefore, to obtain satisfactory RQ values (

characteristics of different buildings (e.g. construction materials & ventingbehaviour).5.79 A REI for buildings treated at 150 mg/m 3 (Scenarios 17-23, 24 & 25) should beset at 5 days after the onset of ventilation, to allow for some uncertainties in thecharacteristics of different buildings.5.80 For domestic uses (Scenarios 26-29) and uses in public spaces (Scenario 30)estimates of exposure and risk are considered in the next section on Bystandersand Residents.Dichlorvos reassessment – application Page 330 of 436

Conclusions on re-entry worker exposure estimates and risk assessment5.81 Only a few scenarios for existing uses of dichlorvos gave acceptable risks for reentryworkers, and acceptable re-entry generally requires the use of PPE and/orRPE plus in some cases a Restricted Entry Interval (REI) is also needed.5.82 Re-entry into cereals treated at 0.8kg a.s./ha (Scenarios (3b)(4b)(Table XII) forscouting and similar activities are acceptable provided PPE (hood/visor + overallsover long-sleeved shirt and long-legged trousers + boots + gloves) and RPE (atleast a half-face respirator) are worn. All other outdoor uses (Scenarios 1 & 2,strawberries; Scenarios 3a,c & 4a,c, vegetables & berries; Scenarios 5 & 6, fruit(tamarillo/ persimmons/ berry); Scenarios 7 & 8, passionfruit) were associatedwith unacceptable re-entry risks even with the use of the highest PPE/RPEoptions.5.83 Re-entry for ventilation into glasshouses in crop production (Scenarios 9 - 12)treated at 50 mg/m 3 would be acceptable 4 hours after application, if exposure waslimited to 30 minutes, and with the use of PPE (hood/visor + overalls over longsleevedshirt and long-legged trousers + boots + gloves) and RPE (full-face or airhose).5.84 Re-entry for other tasks (tending/harvesting crops) of glasshouses in cropproduction (Scenarios 9 - 12) treated at 50 mg/m 3 would be acceptable if a REI of4 hours after the onset of ventilation (i.e. at least 8 hours after application) wasapplied, and if exposure was limited to only 2 hours per day with the use of PPE(hat + goggles + overalls over long-sleeved shirt and long-legged trousers + boots+ gloves). [Note the REI (like the others proposed) attempts to allow foruncertainties to account for the characteristics of different buildings (e.g.construction materials & venting behaviour).]5.85 Re-entry for ventilation into glasshouses or similar facilities used for Cymbidiumproduction treated at 1300 or 1800g a.i./ha (52 or 72 mg/m 3 ; Scenarios 13-16)would be acceptable 4 hours after application if exposure was limited to 30minutes, and PPE (hood/visor + overalls over long-sleeved shirt and long-leggedtrousers + boots + gloves) and RPE (full-face or air-hose) were used.5.86 Re-entry for other tasks (tending/harvesting) in glasshouses or similar facilitiesused for Cymbidium production treated at the lower use rate (1300g a.i./ha or 52mg/m 3 ; Scenarios 13 & 14) would be acceptable if a REI of 4 hours after theonset of ventilation (i.e. at least 8 hours after application) was applied, and ifexposure was limited to only 1 hour per day with the use of PPE (hat + goggles +overalls over long-sleeved shirt and long-legged trousers + boots + gloves).5.87 Re-entry to mushroom houses (Scenarios 9-12) for any purpose would beacceptable if a REI of 48 hours after treatment applied, and if exposure waslimited to only 2 hours per day with the use of PPE (hat + goggles + overalls overlong-sleeved shirt and long-legged trousers + boots + gloves). This proposed REIis based on limited information, noting the uncertainties about the behaviour ofdichlorvos in /on mushrooms and in mushroom houses.Dichlorvos reassessment – application Page 331 of 436

5.88 Re-entry for ventilation of industrial buildings treated at 50 mg/m 3 (Scenarios 17-23) would be acceptable 10 hours after application if exposure was limited to 30minutes, and RPE (at least half-face) was used.5.89 Re-entry for ventilation of industrial buildings treated at 150 mg/m 3 (Scenarios17-23, 24 & 25) would be acceptable 10 hours after application if exposure waslimited to 30 minutes, and RPE (at least half-face) was used.5.90 Re-entry for other tasks into industrial buildings treated at 50 mg/m 3 (Scenarios17-23) would be acceptable if a REI of 3 days after the onset of ventilationapplied, with no PPE or RPE required. [Note that this REI also assumes thedissipation rates in an unventilated and ventilated building have more to do withdichlorvos and the nature of the building itself, rather than the form in which thedichlorvos is applied (gas, fogging solution or aerosol).] While the modellingdoes not demonstrate PPE/RPE is required, the use of some PPE/RPE is goodpractice due to the uncertainties in the estimates.5.91 Re-entry for other tasks into industrial buildings treated at 150 mg/m 3 (Scenarios17-23, 24 & 25) would be acceptable if a REI of 5 days after the onset ofventilation was applied and in this instance no PPE or RPE would be required.[See Note above in 5.90.] While the modelling does not demonstrate PPE/RPE isrequired, the use of some PPE/RPE is good practice due to the uncertainties in theestimates.Dichlorvos reassessment – application Page 332 of 436

6BYSTANDER & RESIDENT EXPOSURE & RISK ASSESSMENTBystander and resident exposure & risk assessment for outdoor usesIntroduction6.1 The main potential sources of exposure to the general public (bystander orresident) from dichlorvos (other than via food residues) is via spray drift at thetime of application or from surfaces contaminated either by spray drift or directtreatment. Bystander and resident exposures would tend to be intermittent incomparison to exposure of workers, who are handling the pesticide throughout theapplication. In addition, spray densities, and hence exposure levels drop off withdistance from spraying operations.6.2 TCL notes that any potential bystanders or residents will not be directly handlingthe substance, and they will not be wearing PPE. [Note: amateur, home users arenot considered bystanders or residents while using pesticides.]6.3 UK CRD Bystander Exposure Guidance Document (UK CRD, 2008b) givesmodels for estimating bystander exposure in three circumstances:• Exposure from spray drift at the time of application;• Exposure from inhalation of pesticide which volatilises from the crop or soilsurface after the application has been made; and• Exposure through contact with spray drift contaminated surfaces.6.4 Of these options, the Agency has advised TCL that the first two approachesshould not be used due to concerns about these models. The UK CRD model forexposure through contact with spray drift contaminated surfaces (UK CRD,2008b) is used with the addition of the US EPA model estimate of spray driftcontaminated soil/grass ingestion by young children (US EPA, 2006b).Children’s dermal exposure (UK CRD, 2008b)6.5 Systemic exposures via the dermal route were calculated using the UK CRD(2008b) default drift fallout values (1% from boom sprayers (Scenarios 1-4); 10%from air-assisted sprayers (Scenarios 5 & 6)) and the following equation:SE(d) = AR x DF x TTR x TC x H x DA / BWWhere:SE(d) = systemic exposure via the dermal routeAR = field application rate (μg/cm 2 )DF = drift fallout valueTTR = turf transferable residuesTC = transfer coefficientH = exposure duration for a typical day (hours) – this has been assumed tobe 2 hours which matches the 75th percentile for toddlers playing on grassDichlorvos reassessment – application Page 333 of 436

in the EPA Exposure Factors HandbookDA = percent dermal absorption (30%)BW = body weight - 15kg which is the average of UK 1995-7 Health Surveys forEngland values for males and females of 2 and 3 yrsChildren’s hand-to-mouth exposure (UK CRD, 2008b)6.6 Hand-to-mouth exposures were calculated using turf transferable residue levelsusing the following equation:SE(h) = AR x DF x TTR x SE x SA x Freq x H / BWWhere:SE(h) = systemic exposure via the hand-to-mouth routeAR = field application rate (μg/cm 2 )DF = drift fallout valueTTR = turf transferable residuesSE = saliva extraction factor – the default value of 50% was usedSA = surface area of the hands – the assumption used here is that 20 cm 2 of skinarea is contacted each time a child puts a hand in his or her mouth (this isequivalent to the palmar surface of three figures; UK CRD default value).Freq = frequency of hand to mouth events/hour – for short term exposures thevalue of 20 events/hours is used, this is the 90th percentile of observations thatranges from 0 to 70 events/hourH = exposure duration (hours) – this has been assumed to be 2 hours whichmatches the 75th percentile for toddlers playing on grass in the EPA ExposureFactors HandbookBW = body weight - 15kg which is the average of UK 1995-7 Health Surveys forEngland values for males and females of 2 and 3 yrsChildren’s object-to-mouth exposure (UK CRD, 2008b)6.7 Object to mouth exposures were calculated using turf transferable residue levelsusing the following equation:SE(o) = AR x DF x TTR x IgR / BWWhere:SE(o) = systemic exposure via mouthing activityAR = field application rate (μg/cm 2 )DF = drift fallout valueTTR = turf transferable residuesIgR = ingestion rate for mouthing grass/day – this was assumed to be equivalentto 25cm 2 of grass/dayBW = body weight – 15kg which is the average of UK 1995–7 Health Surveys forEngland values for males and females of 2 and 3 yrs.Dichlorvos reassessment – application Page 334 of 436

Children’s incidental ingestion of soil (US EPA, 2006b)6.8 The approach used to calculate doses that are attributable to soil ingestion is:Where:ADOD = (AR x DF) x F x IgR x SDF / BWADOD = oral dose on day of application (mg/kg b.w./day)AR = application rate (mg/cm 2 ) [Note: this value has been modified by the DFvalues used in the first 3 equations to reflect these spray drift situations, and notdirect turf applications.]F = fraction or residue retained on uppermost 1 cm of soil (%) (note: this is anadjustment from surface area to volume)SDF = soil density factor -- volume of soil (cm 3 ) per microgram of soil;IgR = ingestion rate of soil (mg/day)BW = body weight (kg)Assumptions:F - fraction or residue retained on uppermost 1 cm of soil is 100 percent based onsoil incorporation into top 1 cm of soil after application (1.0/cm)SDF = soil density factor -- volume of soil (cm 3 ) per gram of soil; to weight 6.7 x10 -4 cm 3 /mg soil)IgR - ingestion rate of soil is 100 mg/dayBW - body weight of a toddler is 15 kg6.9 These models have been applied to two potential New Zealand use patterns: boomspraying at 0.6 mg/ml (Scenarios 1-4); and, air assisted spraying at 1.026 mg/ml(Scenarios 5 & 6; 7 & 8). Applications in passionfruit (Scenarios 7 & 8) arestated to be carried out with knapsack sprayers, and as the target is high-level thedrift fallout value (DF) for air assisted spraying (10%) had been used rather thanground boom value (1%). This approach is likely to be extremely precautionary.6.10 No New Zealand monitoring studies of airborne dichlorvos at application sites areavailable to estimate possible public exposure, or modify the default assumptionsof these models. However, some relevant experimental data from Casida et al. ondichlorvos dissipation are available, and these are discussed above in Section 5.5% of a 0.1% aqueous 32 P-dichlorvos solution remained on the leaf surfaces ofmaize, cotton and peas 20 minutes after application, while about 50% wasvolatilised and 45% absorbed by the plant (Casida et al., 1962 in WHO/IPCS,1971; APVMA, 2008b). In which case, the TTR turf transferable residue factor inthe UK CRD equations, which is set at 5% (the US EPA default value) needs to bemodified to reflect that the Casida et al. data indicates that only 5% is availablefor transfer, while the TTR suggests only 5% of the available remaining residueon the foliage is actually transferred. See Appendix 6 and Table XX.6.11 For non-cancer (or toxicological endpoints with thresholds) risks, the estimatedexposures to dichlorvos are compared to the AOEL (0.0014 mg/kg b.w./day) toDichlorvos reassessment – application Page 335 of 436

determine the Risk Quotient (RQ). The AOEL was considered the mostappropriate benchmark for residents as it was based on a 28-day human NOAELwhen repeat dosing would have achieved steady-state levels, and be adequatelyprotective for expected residential exposure scenarios.Dichlorvos reassessment – application Page 336 of 436

Table XX: Spray driftExposure throughcontact withspray driftcontaminated surfaces(cumulative) (μg/kgb.w./day)ScenarioChild‘s dermalexposureaChild‘s hand-tomouthexposureaChild‘s object-tomouthexposureaChild‘s soilingestionbBoom sprayers (Scenarios 1-4) c(0.8 kg/ha; 0.6 mg/ml)Exposure(μg/kg b.w./day)Dichlorvos:Bystander Internal Exposure Estimates and Risk Assessment aAir assisted sprayers (Scenarios 5&6) Knapsack sprayers (Scenarios 7&8)(2.052 kg/ha; 1.026 mg/ml) d (1.026 kg/ha; 1.026 mg/ml) dRisk Quotient(RQ) e Exposure(μg/kg b.w./day)Risk Quotient(RQ) eExposure(μg/kg b.w./day)0.0416 1.0670 0.53350.0053 0.1360 0.06800.0013 0.0334 0.0167 1 indicates the likelihood of an unacceptable risk tothose exposed. [NB: Due to the low exposure estimates this table expresses the results in micrograms]Dichlorvos reassessment – application Page 337 of 436

Bystander and resident exposure & risk assessment for indoor horticultural uses andenclosed industrial buildings6.12 Where application is into structures (glass- and mushroom houses and industrialbuildings), bystander exposure should not occur unless an accident occurred or thestructure was not properly sealed before treatment.6.13 Intentional or inadvertent venting could result in dichlorvos escaping from thetreated structure as a point source plume carried by the wind until degradation ordeposition. Intentional venting should result in relatively small amounts ofdichlorvos (vapour) entering the atmosphere, in relation to the outside airspace,but modelling was not attempted.Resident exposure & risk assessment for domestic and public space uses6.14 Where application is into enclosed industrial buildings, bystander exposure shouldnot occur unless an accident happens or the structure was not properly sealedbefore treatment. Risks to returning workers are considered in the above sectionon Post-application or Re-entry Worker Exposures and Risk Assessment.6.15 However, where application is into domestic buildings, patios/decks or publicspaces individuals may have direct contact with contaminated surfaces andmouthable objects. Children with their potential for high contact, exploratorynature and low body weight appear to be the most at risk. Available models willoffer worst-case exposure estimates.6.16 The models used previously (§ 6.5-6.8) to estimate children‘s exposure throughcontact with spray drift contaminated surfaces are used, assuming that the averagedrift value is 100% (i.e. the surface is directly sprayed and the spray remainswhere applied) and no dissipation occurs before and during the 2 hours of contact.[See Appendix 6 and Table XXI].Table XXI: Dichlorvos – Domestic UsesBystander Internal Exposure Estimates and Risk Assessment aScenarios (26 & 27) Indoor:Exposure through contactwithcontaminatedsurfaces(cumulative)(mg/kg b.w./day)Scenarios (28 & 29)Outdoor:Exposure(mg/kg b.w./day)Child‘s dermalexposure a 1.200Child‘s hand-to-mouthexposure a 0.0333Child‘s object-to-mouthexposure a 0.0083Child‘s soil ingestion b -Risk Quotient(RQ) cChild‘s total exposure 1.2417 887Child‘s dermalexposure a 1.200Dichlorvos reassessment – application Page 338 of 436

Exposure through contactwithcontaminatedsurfaces(cumulative)(mg/kg b.w./day)acChild‘s hand-to-mouthexposure a 0.0333Child‘s object-to-mouthexposure a 0.0083Child‘s soil ingestion b 0.0011Child‘s total exposure 1.2428 888UK CRD Bystander Exposure Guidance Document (2008b); b US EPA (2006b);Where: Dermal absorption = 30%; Inhalation absorption = 100%;RQ = Estimated Residential Exposure / AOEL where AOEL = 0.0014 mg/kg b.w./day; RQ > 1indicates the likelihood of an unacceptable risk to those exposed.6.17 The calculated exposures will have been over-estimated in these models, becauseno dissipation of dichlorvos has been factored in due to lack of relevantinformation on the behaviour of dichlorvos after the treatment of residentialhouses with furniture, soft furnishings etc. (Scenarios 26 & 27). In the outdooruses (Scenarios 28 & 29) the treated surfaces could be anything from concrete(reported to cause rapid degradation) to wooden decks which may act as areservoir (Hussey & Hughes, 1963 in APVMA, 2008b).6.18 For public space application, children with their potential for high contact,exploratory nature and low body weight appear to be the most at risk, andavailable models will offer worst-case exposure estimates.6.19 The models used previously (§ 6.5-6.8) to estimate children‘s exposure throughcontact with spray drift contaminated surfaces are used, assuming that the averagedrift value is 100% (i.e. the surface is directly sprayed and the spray remainswhere applied) and no dissipation occurs before and during the 2 hours of contact.[See Appendix 6 and Table XXII].Scenario (30) Indoor:Table XXII: Dichlorvos – Public Space Uses (1 hectare)Bystander Internal Exposure Estimates and Risk Assessment aExposure through contactwithcontaminatedsurfaces(cumulative)(mg/kg b.w./day)acExposure(mg/kg b.w./day)Child‘s dermalexposure a 0.104Child‘s hand-to-mouthexposure a 0.0133Child‘s object-to-mouthexposure a 0.0033Child‘s soil ingestion b 0.0001Risk Quotient(RQ) cChild‘s total exposure 0.1207 86UK CRD Bystander Exposure Guidance Document (2008b); b US EPA (2006b);Where: Dermal absorption = 30%; Inhalation absorption = 100%;RQ = Estimated Residential Exposure / AOEL where AOEL = 0.0014 mg/kg b.w./day; RQ > 1Dichlorvos reassessment – application Page 339 of 436

indicates the likelihood of an unacceptable risk to those exposed.6.20 Again, the calculated exposures will have been over-estimated in these models,because no dissipation of dichlorvos has been factored in due, in part, to thecomplexity of what constitutes public spaces that may include concrete, parks,beaches, play grounds etc. (Scenario 30).Dichlorvos reassessment – application Page 340 of 436

Conclusions on bystander and residential exposure estimates from spray drift:6.21 No reliable exposure models were available to assess bystander exposures tospray drift at time of application or inhalation of volatilised pesticides followingapplication.6.22 Residential exposure estimates from outdoor uses of dichlorvos were estimated byconsidering risks to young children from surfaces contaminated by spray drift.The risks were calculated to be acceptable after boom sprayer use at 0.8 kg a.i./ha(Scenarios 1-4), and from air assisted sprayers at 2.052 or 1.026 kg dichlorvos/ha(Scenarios 5-6 and 7-8) (see Table XX).6.23 Applications into structures (glass- and mushroom houses, Scenarios 13-16; andindustrial buildings, Scenarios 17-25) should not result in bystander exposureunless an accident occurred or the structure was not properly sealed beforetreatment.6.24 Intentional or inadvertent venting from the treated structure could result indichlorvos escaping as a point source plume carried by the wind until degradationor deposition, but modelling was not attempted. The amounts of dichlorvos fromeach individually treated facility would be relatively small in relation to theoutside airspace.6.25 Estimated exposures to children after domestic uses indoors (Scenarios 26 & 27)and outdoors (Scenarios 28 & 29) indicate very high risks (RQs of >>1,) couldresult from contact with contaminated surfaces (i.e. from carpets, soft furnishings,floors etc.). While the calculated exposures will have been over-estimated inthese models, because no dissipation of dichlorvos has been factored in [see TableXXI], the risk levels are unacceptably high.6.26 Estimated exposures to children after public space applications (Scenario 30)indicate very high risk (RQs of >>1) could result from contact with contaminatedsurfaces (i.e. from playing on sprayed turf). While, the calculated exposures willhave been over-estimated in these models, because no dissipation of dichlorvoshas been factored in [see Table XXII], the risk levels are unacceptably high.Dichlorvos reassessment – application Page 341 of 436

7 SUMMARY AND CONCLUSIONS7.1 TCL estimated occupational exposures to dichlorvos from proposed outdoor andindoor uses summarised in the following Table (XXIII).Table XXIII: Dichlorvos Use ScenariosScenario Crop/Use Method Rate ApplicationsOutdoorEquipment Details Formu-lationApplicationrateArea orvolumetreatedNo. peryearInterval(days)1 Strawberries Low boom Fine – EC 800 20 ha 1 -mediumg a.i./ha2 droplet2 73 Vegetables, High boom Fine – EC 800 20 ha 1 -cereals,mediumg a.i./ha4 berriesdroplet2 75 FruitAirblast FinemediumEC 2052 8 ha 1 -6g a.i./haberry)(tamarillo/persimmons/droplet2 79 Glasshouse Automatic Fog RTU 0.05 25000 m 3 1 -crops/ applicationgas g/m 3 (1.25 ha)10mushrooms2 711 EC 1 -Fog12 2 713 Glasshouse Automatic Fog/low EC 1300 0.1 ha 1 -flowers application volumeg a.i./ha (2500 m 3 )14 (Cymbidium)mister2 77 Passionfruit Knapsack Finemediumg a.i./haEC 1026 1 ha 1 -8 droplet2 715 Hand held Finemediumg a.i./ha (5000 m 3 )EC 1800 0.2 ha 1 -sprayer16 droplet2 7Indoor17 Enclosed Automatic Fog RTU 0.05 & 0.15 375, 1 -space applicationgas g a.i./ m 3 3750 &18 (industrial)12500 2 7m 3 )19 Manual Fog RTU 0.05 & 0.151 -Foggergas g a.i./ m 3 2 720 Automatic Fog EC 0.05 & 0.151 -21applicationg a.i./ m 32 7Dichlorvos reassessment – application Page 342 of 436

Table XXIII: Dichlorvos Use ScenariosScenario Crop/Use Method Rate ApplicationsEquipment Details Formu-lationApplicationrateArea orvolumetreatedNo. peryearInterval(days)22 Manual Fog EC 0.05 & 0.151 -23foggerg a.i./ m 32 724 High Fine- EC 0.1 & 0.3 150, 1 -pressure mediumg a.i./ m 2 1500 &25 hand-wand droplet2500 m 2 2 7orequivalent26 Domestic use RTU Aerosol 3.1 0.25 g 7.44 m 2 1 -aerosol (manual g a.i./L a.i./m 227 )2 728 Knapsack FinemediumRTU 0.3 g a.i./m 2 60 m 2 1 -29liquida.i./L;4Lpack)droplet (4.4g2 7Outdoor – public space30 Public outdooruseManualfoggerFog EC 1500 ga.i./ha1 ha 1 -Operator exposures and risk assessment:7.2 Scenarios 1-16 give unacceptable risks for operators (mixer/loader/applicators),even with PPE, RPE and engineering controls, where appropriate, except forScenarios (9 & 10) (automated fogging operations with RTU gas in glasshouses insome cases) and Scenarios (13 & 14) (automated fogging with EC solutions inCymbidium production, with restrictions). No outdoor uses of dichlorvos instrawberries, vegetables, cereal berries, fruit trees or passion fruit gave acceptableoperator risk estimates (Scenarios 1-8).7.3 Vegetables/Mushrooms: RTU dichlorvos gas through automatic spray systems at50 mg/m 3 may be used for the fogging of glasshouse crops/ mushrooms(Scenarios 9 & 10), provided: work day exposure is limited to the use of only onedichlorvos gas cylinder, and half-face respirator, chemical-resistant gloves,overalls, eye protection and boots are worn. Two dichlorvos gas cylinders, as amaximum, can be handled in a day (see Table VI) provided: a full-face respirator,chemical-resistant gloves, overalls, eye protection and boots are worn duringcylinder changeover. The cylinder change over restriction means that only small(approximately 0.25 ha) spaces can be treated with 7 L cylinders, but treatment oflarger spaces (up to 1.25 ha) is possible using 35L cylinders using automatedsystems.Dichlorvos reassessment – application Page 343 of 436

7.4 Cymbidium: EC dichlorvos solutions through automatic spray systems at 1.3kga.i./ha may be used for fogging glasshouses during Cymbidium production(Scenarios 13 & 14), provided: work day exposure is limited to 0.1ha (1,000m 2 ),and a respirator of at least A1P2 specification, eye protection and chemicalresistant gloves are worn during mixing/loading. Automated treatment or manualfine spray application at 1.8 kg a.i./ha in glasshouses for Cymbidium productiondo not give acceptable risk estimates..7.5 As can be seen from Tables VI-VIII above, some of the enclosed spaceapplications give acceptable risks for operators if adequate PPE and RPE areworn. In some cases the length of work exposure (area/volume treated) also needsto be limited.7.6 RTU dichlorvos gas through automatic spray systems at 50 mg/m 3 may be usedfor the fogging of enclosed industrial spaces of 375 or 3750 m 3 (Scenarios 17 &18; Table VI), provided: work day exposure is limited to the use of only onedichlorvos gas cylinder, and half-face respirator, chemical-resistant gloves,overalls, eye protection and boots are worn during cylinder changeover. RTUdichlorvos gas through automatic spray systems at 50 mg/m 3 may be used for thefogging of enclosed industrial spaces of 12500 m 3 (Scenarios 17 & 18), provided:work day exposure is limited to the use of only two dichlorvos gas cylinders, andfull-face respirator, chemical-resistant gloves, overalls, eye protection and bootsare worn during cylinder changeover. Thus Scenarios 17 and 18 give acceptablerisk estimates for all treatment volumes, provided sufficient PPE/RPE is worn.7.7 Application of RTU dichlorvos gas at 50 mg/m 3 may be used for the manualfogging of enclosed industrial spaces of 375 m 3 (Scenarios 19; Table VI),provided: work day exposure is limited to 1.5 minutes exposure, the use of onlyone dichlorvos gas cylinder, and half-face respirator and chemical-resistant glovesare worn during cylinder changeover.7.8 Application of RTU dichlorvos gas at 50 mg/m 3 may be used for the manualfogging of enclosed industrial spaces of 3750 m 3 (Scenarios 19; Table VI),provided: work day exposure is limited to 15 minutes exposure, the use of onlyone dichlorvos gas cylinder, a half-face respirator and chemical-resistant glovesare worn during cylinder changeover, and air-hose respirator or SCBA, chemicalresistantgloves, chemical-resistant full-body suit, eye protection and boots areworn during application. Thus for Scenario 19, manual treatment of largervolumes (≥3750 m 3 ) does not give acceptable estimates even with air hose RPEduring application. The risk estimate is primarily driven by the APVMA cylinderchange exposure estimates which mean that the use of two cylinders per day isunacceptable even with PPE/RPE during changeover.7.9 Mixing/loading fogging solutions at 0.05g a.i./m 3 for application throughautomatic spray systems into enclosed industrial spaces of 375 m 3 (Scenarios 20& 21; Table VII) may be done, provided: work day exposure is limited to thespecified volume, and a respirator of at least A1P2 specification, chemicalresistantgloves, overalls, eye protection and boots are worn duringDichlorvos reassessment – application Page 344 of 436

mixing/loading. Mixing/loading fogging solutions at 0.15g a.i./m 3 for applicationthrough automatic spray systems into enclosed industrial spaces of 375 m 3(Scenarios 20 & 21) may be done, provided: work day exposure is limited to thespecified volume, and a respirator of at least A1P2 specification, chemicalresistantgloves, overalls, eye protection and boots are worn duringmixing/loading. Thus for Scenarios 20 & 21, only the smallest treatment volumesgive acceptable risk estimates due to the exposure during mixing/loading, but notlarger volumes (≥3750 m 3 ).7.10 Manual application of fogging solutions at 0.05 or 0.15g a.i./m 3 into enclosedindustrial spaces of 375 m 3 (Scenarios 22 & 23; Table VII), may be doneprovided: work day exposure is limited the specified volume, and half-facerespirator (at least A1P2 specification), chemical-resistant gloves, overalls, eyeprotection and boots are worn during mixing/loading and application. Thus forScenarios 22 & 23, only the smallest treatment volumes give acceptable riskestimates primarily due to the exposure during mixing/loading.7.11 The surface spraying of the smallest space 150 m 2 at 0.1g a.i./m 2 using highpressure handwand (Scenarios 24 & 25; Table VIII), may be done provided: workday exposure is limited the specified area, and a half-face respirator, chemicalresistantgloves, chemical-resistant full-body suit, eye protection and boots areworn during mixing/loading and application.7.12 The surface spraying of the smallest space 150 m 2 at 0.30g a.i./m 2 using highpressure handwand (Scenarios 24 & 25; Table VIII), may be done provided: workday exposure is limited the specified area, and air-hose respirator or SCBA,chemical-resistant gloves, chemical-resistant full-body suit, eye protection andboots are worn during mixing/loading and application. Thus for Scenarios 24 &25, surface spraying of larger spaces (1500 or 2500 m 2 ) at either application rategive unacceptable risk estimates primarily due to the exposure duringmixing/loading.7.13 Both the domestic uses that are assumed to be carried out by amateurs without theuse of PPE or RPE, surface/crevice RTU gas applications indoors over 7.44m 2(Scenarios 26 & 27) and larger outdoor spaces with RTU spray-mixes and aknapsack sprayer (Scenarios 28 & 29) are predicted to give unacceptable risks.7.14 The public space application (Scenario 30) (for professional applicators) gives anunacceptable risk even for only 1 hectare when wearing a chemical resistant fullbodysuit and air-hose RPE or SCBA.Re-entry worker exposures and risk assessment:7.15 Only a few scenarios for existing uses of dichlorvos gave acceptable risks for reentryworkers, and acceptable re-entry generally requires the use of PPE and/orRPE plus in some cases a Restricted Entry Interval (REI) is also needed.Dichlorvos reassessment – application Page 345 of 436

7.16 Re-entry into cereals treated at 0.8kg a.s./ha (Scenarios (3b)(4b)(Table XII) forscouting and similar activities are acceptable provided PPE (hood/visor + overallsover long-sleeved shirt and long-legged trousers + boots + gloves) and RPE (atleast a half-face respirator) are worn. All other outdoor uses (Scenarios 1 & 2,strawberries; Scenarios 3a,c & 4a,c, vegetables & berries; Scenarios 5 & 6, fruit(tamarillo/ persimmons/ berry); Scenarios 7 & 8, passionfruit) were associatedwith unacceptable re-entry risks even with the use of the highest PPE/RPEoptions.7.17 Re-entry for ventilation into glasshouses in crop production (Scenarios 9 - 12)treated at 50 mg/m 3 would be acceptable 4 hours after application, if exposure waslimited to 30 minutes, and with the use of PPE (hood/visor + overalls over longsleevedshirt and long-legged trousers + boots + gloves) and RPE (full-face or airhose).7.18 Re-entry for other tasks (tending/harvesting crops) of glasshouses in cropproduction (Scenarios 9 - 12) treated at 50 mg/m 3 would be acceptable if a REI of4 hours after the onset of ventilation (i.e. at least 8 hours after application) wasapplied, and if exposure was limited to only 2 hours per day with the use of PPE(hat + goggles + overalls over long-sleeved shirt and long-legged trousers + boots+ gloves). [Note the REI (like the others proposed) attempts to allow foruncertainties to account for the characteristics of different buildings (e.g.construction materials & venting behaviour).]7.19 Re-entry for ventilation into glasshouses or similar facilities used for Cymbidiumproduction treated at 1300 or 1800g a.i./ha (52 or 72 mg/m 3 ; Scenarios 13-16)would be acceptable 4 hours after application if exposure was limited to 30minutes, and PPE (hood/visor + overalls over long-sleeved shirt and long-leggedtrousers + boots + gloves) and RPE (full-face or air-hose) were used.7.20 Re-entry for other tasks (tending/harvesting) in glasshouses or similar facilitiesused for Cymbidium production treated at the lower use rate (1300g a.i./ha or 52mg/m 3 ; Scenarios 13 & 14) would be acceptable if a REI of 4 hours after theonset of ventilation (i.e. at least 8 hours after application) was applied, and ifexposure was limited to only 1 hour per day with the use of PPE (hat + goggles +overalls over long-sleeved shirt and long-legged trousers + boots + gloves).7.21 Re-entry to mushroom houses (Scenarios 9-12) for any purpose would beacceptable if a REI of 48 hours after treatment applied, and if exposure waslimited to only 2 hours per day with the use of PPE (hat + goggles + overalls overlong-sleeved shirt and long-legged trousers + boots + gloves). This proposed REIis based on limited information, noting the uncertainties about the behaviour ofdichlorvos in /on mushrooms and in mushroom houses.7.22 Re-entry for ventilation of industrial buildings treated at 50 mg/m 3 (Scenarios 17-23) would be acceptable 10 hours after application if exposure was limited to 30minutes, and RPE (at least half-face) was used.Dichlorvos reassessment – application Page 346 of 436

7.23 Re-entry for ventilation of industrial buildings treated at 150 mg/m 3 (Scenarios17-23, 24 & 25) would be acceptable 10 hours after application if exposure waslimited to 30 minutes, and RPE (at least half-face) was used.7.24 Re-entry for other tasks into industrial buildings treated at 50 mg/m 3 (Scenarios17-23) would be acceptable if a REI of 3 days after the onset of ventilationapplied, with no PPE or RPE required. [Note that this REI also assumes thedissipation rates in an unventilated and ventilated building have more to do withdichlorvos and the nature of the building itself, rather than the form in which thedichlorvos is applied (gas, fogging solution or aerosol).] While the modellingdoes not demonstrate PPE/RPE is required, the use of some PPE/RPE is goodpractice due to the uncertainties in the estimates.7.25 Re-entry for other tasks into industrial buildings treated at 150 mg/m 3 (Scenarios17-23, 24 & 25) would be acceptable if a REI of 5 days after the onset ofventilation was applied and in this instance no PPE or RPE would be required.[See Note above in 5.90.] While the modelling does not demonstrate PPE/RPE isrequired, the use of some PPE/RPE is good practice due to the uncertainties in theestimates.Bystander and resident exposures and risk assessment:7.26 No reliable exposure models were available to assess bystander exposures tospray drift at time of application or inhalation of volatilised pesticides followingapplication.7.27 Residential exposure estimates from outdoor uses of dichlorvos were estimated byconsidering risks to young children from surfaces contaminated by spray drift.The risks were calculated to be acceptable after boom sprayer use at 0.8 kg a.i./ha(Scenarios 1-4), and from air assisted sprayers at 2.052 or 1.026 kg dichlorvos/ha(Scenarios 5-6 and 7-8) (see Table XX).7.28 Applications into structures (glass- and mushroom house, Scenarios 13-16; andindustrial buildings, Scenarios 17-25) should not result in bystander exposureunless an accident occurred or the structure was not properly sealed beforetreatment.7.29 Intentional or inadvertent venting from the treated structure could result indichlorvos escaping as a point source plume carried by the wind until degradationor deposition, but modelling was not attempted. The amounts of dichlorvos fromeach individually treated facility would be relatively small in relation to theoutside airspace.7.30 Estimated exposures to children after domestic uses indoors (Scenarios 26 & 27)and outdoors (Scenarios 28 & 29) indicate very high risks (RQs of >>1,) couldresult from contact with contaminated surfaces (i.e. from carpets, soft furnishings,floors etc.). While the calculated exposures will have been over-estimated inthese models, because no dissipation of dichlorvos has been factored in [see TableXXI], the risk levels are unacceptably high.Dichlorvos reassessment – application Page 347 of 436

7.31 Estimated exposures to children after public space applications (Scenario 30)indicate very high risk (RQs of >>1) could result from contact with contaminatedsurfaces (i.e. from playing on sprayed turf). While, the calculated exposures willhave been over-estimated in these models, because no dissipation of dichlorvoshas been factored in [see Table XXII], the risk levels are unacceptably high.Dichlorvos reassessment – application Page 348 of 436

REFERENCES:APVMA, 2008a. ―DICHLORVOS - Toxicology Assessment: The reconsideration ofapprovals of the active constituent, registrations of products containing dichlorvos andapprovals of their associated labels.‖ Australian Pesticides & Veterinary MedicinesAuthority, KINGSTON ACT 2604; 2008.APVMA, 2008b. ―DICHLORVOS - OCCUPATIONAL HEALTH AND SAFETYASSESSMENT: The reconsideration of approvals of the active constituent, registrationsof products containing dichlorvos and approvals of their associated labels.‖ AustralianPesticides & Veterinary Medicines Authority, KINGSTON ACT 2604; 2008.ATSDR, 1997. ―TOXICOLOGICAL PROFILE FOR DICHLORVOS‖ Agency forToxic Substances and Disease Registry, Atlanta, Georgia 30333; 1997.CalDPR, 1996. ―DICHLORVOS (DDVP): RISK CHARACTERIZATIONDOCUMENT.‖ Medical Toxicology and Worker Health and Safety Branches,Department of Pesticide Regulation, California Environmental Protection Agency.Franklin, C. & Worgan, J.P., 2005. ―Occupational and Residential ExposureAssessment for Pesticides.‖ John Wiley and Sons; ISBN 0471489891, 9780471489894.[Abstract only]UK CRD, 1992. ―Uniform Principles for Safeguarding the Health of Applicators ofPlant Protection Products.‖ Biologische Bundesanstalt für Land- und Forstwirtschaft,Bundesgesundheitsamt, und Industrieverband Agrar e.V. ISBN 3489-27700-7. 1992;http://www.pesticides.gov.uk/uploadedfiles/Web_Assets/PSD/German_Model_PSD1.xls [professional mixer/loader/applicator models]UK CRD, 2006; [Amateur: Aerosol Surface Treatment Model]http://www.pesticides.gov.uk/uploadedfiles/Web_Assets/PSD/Amateur%20use%20model2.xlsUK CRD, 2007; [Revised UK Predictive Operator Exposure Model (UK POEM): homegarden model]http://www.pesticides.gov.uk/uploadedfiles/Web_Assets/PSD/UK_POEM_07.xlsUK CRD, 2008a. ―GUIDANCE FOR POST-APPLICATION (RE-ENTRY WORKER)EXPOSURE ASSESSMENT.‖http://www.pesticides.gov.uk/approvals.asp?id=2422&link=%2Fuploadedfiles%2FWeb%5FAssets%2FPSD%2FRe%2Dentry%2520worker%2520guidance%5Ffinal%2520version%2EpdfUK CRD, 2008b. ―BYSTANDER EXPOSURE GUIDANCE.‖http://www.pesticides.gov.uk/approvals.asp?id=2428&link=%2Fuploadedfiles%2FWeb%5FAssets%2FPSD%2FBystander%2520exposure%2520guidance%5Ffinal%2520version%2EpdfDichlorvos reassessment – application Page 349 of 436

UK CRD, 2008c. ―OPERATOR EXPOSURE GUIDANCE FOR AMATEUR (HOMEGARDEN) PESTICIDES.‖http://www.pesticides.gov.uk/uploadedfiles/Web_Assets/PSD/Amateur%20use%20guidance%202.pdfUS EPA, 1997. ―Standard Operating Procedures (SOPs) for Residential ExposureAssessments.‖ Contract No. 68-W6-0030; Work Assignment No. 3385.102 [trac6a05]US EPA, 2000. ―Worker Risk Mitigation for Organophosphate Pesticides.‖ PesticideRegistration (PR) Notice 2000-9 September 29, 2000.US EPA, 2006a. ―Reregistration Eligibility Decision for Dichlorvos (DDVP).‖ Officeof Pesticide Programs, UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY, WASHINGTON D.C., 20460.WHO/IPCS, 1971. ―1970 EVALUATIONS OF SOME PESTICIDE RESIDUES INFOOD.‖ AGP:1970/M/12/1; WHO/FOOD ADD/71.42Dichlorvos reassessment – application Page 350 of 436

Appendix 1:Occupational Exposure Estimates & Risk Assessment with Engineering ControlsPossible engineering controls reported by US EPA (2000) for mitigation of workerexposure risks to organophosphate (OP) pesticides: [Edited for relevance to proposeddichlorvos applications.]―1. Contained/Closed Mixing and Loading Systems―One engineering control available for mixing and loading pesticides is a closed system.By closed system EPA means a system designed by the manufacturer to enclose thepesticide to prevent it from contacting individuals while it is being handled. Under theWPS [Worker Protection Standard], when a closed mixing and loading system is usedcorrectly and maintained according to the manufacturers‘ operating instructions,handlers may reduce some of the personal protective equipment listed on the pesticidelabeling for mixing and loading activities.“a. Mechanical Transfer System. One type of closed system for liquid formulations isa mechanical transfer system that consists of a probe that is inserted into the pesticidecontainer and seals tightly to the pesticide container to prevent liquid (but notnecessarily any vapor) from contacting handlers or other people. The pesticide is eithertransferred directly from its container to a spray tank, or the container is connecteddirectly to the spray system. Mixers and loaders using this closed system are permittedto wear reduced PPE. A mechanical transfer system usually does not meet the definitionof a closed system under the WPS unless inhalation exposure is not a concern; howeverit is considered an engineering control which greatly reduces dermal exposure.“b. Dry Disconnect System. A dry-disconnect system does not meet the definition of aclosed system under WPS unless it is part of a mechanical closed system. Drydisconnect systems are considered to be an engineering control that reduces potentialworker exposure by reducing leakage of liquid when pipes or hoses are uncoupled fromequipment or from other pipes or hoses. Dry-disconnect systems involve fittingsdesigned by the manufacturer to minimize pesticide leakage at each hose disconnectpoint. These systems are often used in conjunction with mechanical transfer systems.‖“2. Enclosed Cabs“a. Enclosed Cabs for Application and Flagging. The engineering control availablefor handlers applying pesticides using motorized ground equipment or flagging tosupport aerial applications is an enclosed cab. By enclosed cab, EPA means a cabhaving a nonporous barrier that totally surrounds the occupants and prevents contactwith pesticides outside of the cab. By definition, all enclosed cabs protect againstdermal exposure. Some enclosed cabs also provide respiratory protection -- they can beequipped with a ventilation system that provides particulate filtration equivalent to aNIOSH-approved dust/mist respirator or that provides organic-vapor-removing andparticulate filtration equivalent to a NIOSH-approved organic-vapor-removingDichlorvos reassessment – application Page 351 of 436

espirator with a dust/mist prefilter. The performance criteria for enclosed cabs arefound in the WPS at 40 CFR Part 170.240(d)(5).―If the occupational risk assessment for such handlers indicates that dermal exposure isthe only exposure route of concern (i.e., inhalation risks are not a concern even when norespirator is worn), then an enclosed cab providing only dermal protection is sufficientlyprotective and will be required on the pesticide labeling. However, if the riskassessment indicates that inhalation risks are a concern unless an appropriate respiratoris worn, then the pesticide labeling will indicate that the enclosed cab must providerespiratory protection equivalent to the type of respirator required for the pesticide orthat the handler must wear the appropriate respirator while inside the enclosed cab …depending on the severity of inhalation risks, EPA may require that enclosed cabs meetperformance criteria beyond those specified in the WPS.―Under the WPS, handlers in any enclosed cab need not wear all of the label-requiredPPE designed for dermal protection (e.g., double layer body protection, or chemicalresistantgloves, footwear, or headgear), provided such PPE is immediately available foruse if the handler exits the enclosed cab in the treated area and contacts treated surfaces.If the manufacturer or a government agency declares that the enclosed cab providesrespiratory protection equivalent to the label-required respirator (and certain use andmaintenance conditions are met), handlers need not wear the respirator while in theenclosed cab. However, the appropriate respirator must be immediately available for useif the handler exits the cab within the treated area.‖ (US EPA, 2000)Effects of various engineering controls on pesticide exposure.The effects of engineering controls on default modelled occupational exposure estimatesand risk assessments for boom and air-blast sprayers are given in the Table below. Thefactors used and descriptions of the engineering controls are also listed.All data are unit exposure values (μg/kg of active ingredient (a.i.) handled), taken fromPHED (1992). Values are central tendency measures based on high confidence datasets. dFactorExposure (μg/kg a.i. handled)Ground boomEngineering controls Closed cab 11.0for ground-boom applicator a Open cab 33.0[Closed cab is assumed to offer 11/33 = 0.33 or 3x the protection factor vis-à-vis Opencabs for ground-boom applicators.]Dichlorvos reassessment – application Page 352 of 436

FactorExposure (μg/kg a.i. handled)Air blastEngineering controls Closed cab 42.0for air-blast applicator b Open cab 561.7[Closed cab is assumed to offer 42/561.7 = 0.075 or 13.4x the protection factor vis-à-visOpen cabs for air-blast applicators.]Mixer/loadersEngineering controls Closed M/L 19.0for M/L (liquids) c Open M/L 51.0[Closed M/L is assumed to offer 19/51 = 0.37 or 2.7x the protection factor vis-à-visOpen M/L for mixer/loaders.]a Ground-boom applicator wearing single layer of clothing and gloves (no hood/visor).b Air-blast applicator wearing single layer of clothing and gloves (no hood/visor).c Mixer/loader (liquids) wearing single layer of clothing and gloves.dFranklin, C. & Worgan, J.P. (2005) ―Occupational and Residential ExposureAssessment for Pesticides.‖ John Wiley and Sons; ISBN 0471489891, 9780471489894.[Abstract only]Dichlorvos reassessment – application Page 353 of 436

Appendix 2:Occupational Exposure Estimates & Risk Assessment with RTU gas cylinders &EC fogging of indoor spacesA) Worker/loader exposures during RTU gas cylinder changing:In the APVMA re-assessment (APVMA, 2008b) they considered that operators mightbe exposed to dichlorvos when changing cylinders during gas fogging of glass- ormushroom houses (Scenarios 9 & 10) and enclosed (industrial) spaces (Scenarios 17, 18& 19).The APVMA estimated dermal exposure to be 0.001 mL/cylinder (equivalent to0.0014g dichlorvos; relative density, 1.425). Inhalation exposure could also result ifsome of the dichlorvos evaporated into the 1m 3 personal air space around the operator‘sbreathing zone. If 0.005ml of dichlorvos (wt. 7.1mg) was available for inhalation for 1minute, then they would inhale 0.12mg or 0.0017 mg/kg b.w. (70kg)In New Zealand, RTU gases are sold in 7 & 35L cylinders, at 50g a.i./L; and, use rates0.05 or 0.15g a.i./m 3 . For example, to cover 1.25ha at the equivalent of 0.05g a.i./m 3requires approximately 1.6kg (31.25L of product) or five 7L cylinders or one 35L (thisassumes a 2.5m building height).Dermal exposure from cylinder changingThe estimated absorbed dose from dermal exposure after 1 cylinder change would be,noting that gloves are assumed to be worn:And, five cylinder changes:Where:SE(d) = CR x WR x DA x PBWSE(d) = 1.4 x 1 x 0.30 x 0.1 = 0.042 = 0.0006 mg/kg b.w.7070SE(d) = 1.4 x 5 x 0.30 x 0.1 = 0.21= 0.003 mg/kg b.w.7070SE(d) = systemic exposure via the dermal routeCR = contamination rate [1.4 mg/cylinder change]WR = Work Rate [cylinder changes/day]DA = percent dermal absorption [30%]P = Penetration Factor for Clothing [gloves, 10%]BW = body weight [70kg]Dichlorvos reassessment – application Page 354 of 436

Inhalation exposure from cylinder changingThe estimated absorbed dose from inhalation exposure after 1 cylinder change wouldbe:SE(i) = CR x WR x IA x PBWAnd, five cylinder changes:Where:SE(i) = 0.12 x 1 x 1 x 1 =0.12= 0.0017 mg/kg b.w.70 70SE(i) = 0.12 x 5 x 1 x 1 =0.6= 0.0086 mg/kg b.w.70 70SE(i) = systemic exposure via the inhalation routeCR = contamination rate [0.12 mg/cylinder change]WR = Work Rate [cylinder changes/day, 1 and 5 respectively]IA = percent inhalation absorption [100%]P = Penetration Factor for RPE [none, 1; half-face respirator, 0.1 (90%protection); full-face, 0.02 (98%); air-hose, nil exposure (100%) (Thongsinthusaket al., 1993 in APVMA, 2008b)]BW = body weight [70kg]If RPE, a half-face respirator (P = 0.1), is worn then the estimated absorbed dose frominhalation exposure after 1 cylinder change would be:SE(i) = 0.12 x 1 x 1 x 0.1 =0.012= 0.00017 mg/kg b.w.70 70If RPE, a half-face respirator (P = 0.1), is worn then the estimated absorbed dose frominhalation exposure after 5 cylinder changes would be:SE(i) = 0.12 x 5 x 1 x 0.1 =0.06 = 0.00086 mg/kg b.w.70 70The equivalent result for 5 cylinder changes with a full-face respirator (P = 0.02) is:SE(i) = 0.12 x 5 x 1 x 0.02 = 0.012 = 0.00017 mg/kg b.w.70 70Dichlorvos reassessment – application Page 355 of 436

B)Operator exposures during manual application of RTU gas or EC fogging solutions:RTU gas containing 50g a.i./L is applied using a manual pressure gun in enclosedspaces of 375, 3750 and 12,500m 3 at use rates of 0.05g a.i./m 3 ; 18.75, 187.5 and 625ga.i. are required respectively for each space (Scenarios 9 & 10, and 17, 18 & 19). At thehigher use rate of 0.15g a.i./m 3 ; 56.25, 562.5 and 1875g a.i. are required respectively foreach space (Scenarios 17, 18 & 19).Exposures at the higher rate will be three times those at 0.05g a.i./m 3 .EC fogging solutions can also be applied at both use rates (Scenarios 22 & 23).Dermal exposures:The APVMA (2008b) used a Pesticide Handlers Exposure Database (PHED) exposuremodel for high pressure handwand application, modified to address the expectation thatthe efflux from a manual pressure gun would be significantly less diffuse and moredirectional, to estimate dermal exposures during enclosed space applications.Head/neck, exterior of clothing and hands were assumed to be contaminated with,respectively 0.018, 2.68 and 0.26 mg/kg active handled, 10% of the values from thePHED high pressure handwand model.For 375 m 3 – dermal exposure:= amount active handled [kg] x (head/neck + clothing + hands) [mg/kg]0.01875 kg a.i. x (0.018 + 2.68 + 0.26) = 0.0555 mg a.i./personThen applying the dermal absorption factor of 30%, and dividing by 70 kg b.w., thesystemic dose will be:(0.0555 x 0.30) / 70 = 0.0167 / 70 = 0.0002 mg/kg b.w.If PPE is considered to mitigate exposures, APVMA used 20% penetration of overalls(Gold & Holsclaw, 1984; Original not sighted); 10% penetration of gloves(Thongsinthusak et al., 1993; Original not sighted); and, 5% penetration of full-bodychemical resistant clothes (Thongsinthusak et al., 1993; Original not sighted):With overalls and gloves (protection factors applied to the body areas covered):[0.01875 x {0.018 + (2.68 x 0.2) + (0.26 x 0.1)} x 0.3] / 70 = (0.0109 x 0.30) / 70 =0.0033 / 70 = 0.00005 mg/kg b.w.With full-body chemical resistant clothes and gloves:Dichlorvos reassessment – application Page 356 of 436

[0.01875 x {(0.018 x 0.05) + (2.68 x 0.05) + (0.26 x 0.1)} x 0.3] / 70 =(0.003 x 0.30) / 70 = 0.0009 / 70 = 0.00001 mg/kg b.w.For 3750 m 3 – dermal exposure:0.1875 kg a.i. x (0.018 + 2.68 + 0.26) = 0.5546 mg a.i./personThen applying the dermal absorption factor of 30%, and dividing by 70 kg b.w., thesystemic dose will be:(0.5546 x 0.30) / 70 = 0.1664 / 70 = 0.0024 mg/kg b.w.With overalls and gloves (protection factors applied to the body areas covered):[0.1875 x {0.018 + (2.68 x 0.2) + (0.26 x 0.1)} x 0.3] / 70 = (0.1088 x 0.30) / 70 =0.0326 / 70 = 0.0005 mg/kg b.w.With full-body chemical resistant clothes and gloves:[0.1875 x {(0.018 x 0.05) + (2.68 x 0.05) + (0.26 x 0.1)} x 0.3] / 70 =(0.0302 x 0.30) / 70 = 0.0091 / 70 = 0.0001 mg/kg b.w.For 12,500 m 3 – dermal exposure:0.625 kg a.i. x (0.018 + 2.68 + 0.26) = 1.8488 mg a.i./personThen applying the dermal absorption factor of 30%, and dividing by 70 kg b.w., thesystemic dose will be:(1.8488 x 0.30) / 70 = 0.5546 / 70 = 0.0079 mg/kg b.w.With overalls and gloves (protection factors applied to the body areas covered):[0.625 x {(0.018 + (2.68 x 0.2) + (0.26 x 0.1)} x 0.3] / 70 = (0.3625 x 0.30) / 70 =0.1088 / 70 = 0.0016 mg/kg b.w.With full-body chemical resistant clothes and gloves:Dichlorvos reassessment – application Page 357 of 436

[0.625 x {(0.018 x 0.05) + (2.68 x 0.05) + (0.26 x 0.1)} x 0.3] / 70 =(0.1006 x 0.30) / 70 = 0.0302 / 70 = 0.0004 mg/kg b.w.Inhalation exposures:For the estimation of inhalation exposures APVMA (2008b) noted that as long as theoperator did not walk back through the efflux stream then the highest airborneconcentration of dichlorvos should be the use rate, 50 mg/m 3 , with a TWA of 25 mg/m 3 .The APVMA estimated the duration of exposure on the application times from themanufacturer‘s specification for the manual pressure gun (70 sec/300 m 3 ; i.e. (375/300x 70) = 87.5 seconds, (3750/300 x 70) = 875 seconds and (12500/300 x 70) = 2917seconds for the New Zealand Scenarios) for larger industrial spaces. [These valueswere rounded to 1.5, 15 and 50 minutes, equivalent to 0.025, 0.25 and 0.83 hourrespectively for the model.] The operator‘s ventilation rate was taken as 1m 3 /hour forlight activities (US EPA, 1996; Original not sighted).For 375 m 3 – inhalation exposure:= airborne concentration (TWA) [mg/m 3 ] x ventilation rate [m 3 /hr] x duration [hr]25 x 1 x 0.025 = 0.625 mg a.i./personThen accepting the inhalation absorption factor of 100%, and dividing by 70 kg b.w.,the systemic dose will be:(0.625 x 1.00) / 70 = 0.0089 mg/kg b.w.If RPE is considered to mitigate exposures, APVMA used 10% penetration of half-facerespirators; 2% penetration of full-face respirators; and, no penetration of air-hoserespirators or SCBA (Thongsinthusak et al., 1993; Original not sighted):With half-face (protection factor applied, 0.1):(25 x 1 x 0.025) / 70 = (0.625 x 0.10) / 70 = 0.0625 / 70 = 0.0009 mg/kg b.w.For 3750 m 3 – inhalation exposure:25 x 1 x 0.25 = 6.25 mg a.i./person.Then accepting the inhalation absorption factor of 100%, and dividing by 70 kg b.w.,the systemic dose will be:(6.25 x 1.00) / 70 = 0.0893 mg/kg b.wDichlorvos reassessment – application Page 358 of 436

With half-face respirator (protection factor applied, 0.1) the inhaled dose is 0.0089mg/kg b.w.With full-face respirator (protection factor applied, 0.02) the inhaled dose is 0.0018mg/kg b.w.For 12,500 m 3 – inhalation exposure:25 x 1 x 0.83 = 20.75 mg a.i./person.Then accepting the inhalation absorption factor of 100%, and dividing by 70 kg b.w.,the systemic dose will be:(20.75 x 1.00) / 70 = 0.2964 mg/kg b.wWith half-face respirator (protection factor applied, 0.1) the inhaled dose is 0.0296mg/kg b.w.With full-face respirator (protection factor applied, 0.02) the inhaled dose is 0.0059mg/kg b.w.The summation of these exposure estimates and derivation of the RQ values ispresented in Table VI.Dichlorvos reassessment – application Page 359 of 436

Appendix 3:Occupational Exposure Estimates & Risk Assessment for Spray Applications intoEnclosed Spaces (Scenarios 24 & 25)Operator (Mixer/Loader/Applicator) during manual application:Spray is manually applied into enclosed spaces of 150, 1500 and 2500 m 2 (equivalentspaces: 375, 3750 and 12,500 m 3 ) at a use rates of 0.1 or 0.3g a.i./m 2 . The higherapplication rate of 0.30g a.i./m 2 would require: 45, 450 and 750g a.i. to be handled andapplied.Exposures at the higher use rate will be three times those at 0.1g a.i./m 2 .Dermal exposures:The APVMA considered the PHED model 35 (mixer/loader/applicators mixing liquidformulations by open pour methods and applying the spraymix with high pressurehandwand) the most appropriate estimation method. The predicted dermal exposurerates on head, body and hands were respectively 1.155, 90.86 and 2.49 mg a.i./kgapplied. The spaces 150, 1500 and 2500 m 2 would require: 15, 150 and 250g a.i. to behandled and applied at 0.1g a.i./m 2 .For 150 m 2 – dermal exposure:= amount active handled [kg] x (head/neck + clothing + hands) [mg/kg]0.015 kg a.i. x (1.155 + 90.86 + 2.49) = 1.4176 mg a.i./personThen applying the dermal absorption factor of 30%, and dividing by 70 kg b.w., thesystemic dose will be:(1.4176 x 0.30) / 70 = 0.4253 / 70 = 0.0061 mg/kg b.w.If PPE is considered to mitigate exposures, APVMA used 20% penetration of overalls(Gold & Holsclaw, 1984; Original not sighted); 10% penetration of gloves(Thongsinthusak et al., 1993; Original not sighted); and, 5% penetration of full-bodychemical resistant clothes (Thongsinthusak et al., 1993; Original not sighted):With overalls and gloves (protection factors applied to the body areas covered):[0.015 x {1.155 + (90.86 x 0.2) + (2.49 x 0.1)} x 0.3] / 70 = (0.2936 x 0.3) / 70 =0.0881 / 70 = 0.0013 mg/kg b.w.Dichlorvos reassessment – application Page 360 of 436

With full-body chemical resistant clothes and gloves:[0.015 x {(1.155 x 0.05) + (90.86 x 0.05) + (2.49 x 0.1)} x 0.3] / 70 =(0.0728 x 0.3) / 70 = 0.0218 / 70 = 0.0003 mg/kg b.w.For 1500 m 2 – dermal exposure:With full-body chemical resistant clothes and gloves:[0.15 x {(1.155 x 0.05) + (90.86 x 0.05) + (2.49 x 0.1)} x 0.3] / 70 = (0.7275 x 0.3) / 70= 0.2182 / 70 = 0.0031 mg/kg b.w.For 2500 m 2 – dermal exposure:With full-body chemical resistant clothes and gloves:[0.25 x {(1.155 x 0.05) + (90.86 x 0.05) + (2.49 x 0.1)} x 0.3] / 70 = (1.2125 x 0.3) / 70= 0.3638 / 70 = 0.0078 mg/kg b.w.At the higher use rate of 0.3g a.i./m 2 requiring 45, 450 and 750g a.i. to be handled andapplied.For 150 m 2 – dermal exposure: With full-body chemical resistant clothes and gloves:[0.045 x {(1.155 x 0.05) + (90.86 x 0.05) + (2.49 x 0.1)} x 0.3] / 70 =(0.2182 x 0.3) / 70 = 0.0655 / 70 = 0.0009 mg/kg b.w.Inhalation exposures:For inhalation exposures from using high pressure handwand equipment indoors,APVMA modified the most relevant PHED model to account for the high volatility ofdichlorvos and estimated an inhalation exposure rate of 13.2 mg a.i./kg applied [50 foldincrease to account for the higher volatility, but also the slower volatilisation and greaterdroplet precipitation of an aerosol compared to a CO 2 pressure gun efflux].For 150 m 2 – inhalation exposure:= amount active handled [kg] x inhalation exposure [mg/kg handled]0.015 x 13.2 = 0.198 mg a.i./personDichlorvos reassessment – application Page 361 of 436

Then accepting the inhalation absorption factor of 100%, and dividing by 70 kg b.w.,the systemic dose will be:(0.198 x 1.00) / 70 = 0.0028 mg/kg b.w.If RPE is considered to mitigate exposures, APVMA used 10% penetration of half-facerespirators; 2% penetration of full-face respirators; and, no penetration of air-hoserespirators or SCBA (Thongsinthusak et al., 1993; Original not sighted):With half-face (protection factor applied, 0.10):(0.015 x 13.2 x 0.10) / 70 = 0.0198 / 70 = 0.0003 mg/kg b.w.With full-face (protection factor applied, 0.02):(0.015 x 13.2 x 0.02) / 70 = 0.0040 / 70 = 0.00006 mg/kg b.w.For 1500 m 2 – inhalation exposure (70kg b.w.):With full-face (protection factor applied, 0.02):(0.15 x 13.2 x 0.02) / 70 = 0.0396 / 70 = 0.0006 mg/kg b.w.For 2500 m 2 – inhalation exposure (70kg b.w.):With full-face (protection factor applied, 0.02):(0.25 x 13.2 x 0.02) / 70 = 0.066 / 70 = 0.0009 mg/kg b.w.The summation of these exposure estimates and derivation of the RQ values ispresented in Table VIII.Dichlorvos reassessment – application Page 362 of 436

Appendix 4:Occupational Exposure Estimates & Risk Assessment for Spray Applications intoPublic Spaces (Scenario 30)Spray is manually applied by fogging over public spaces of up to 1 hectare at a use rateof 0.1g a.i./m 2 (10ml product/ 2L spraymix/ 100m 2 ). This application rate and arearequires 1000g a.i. to be handled and applied.Mixer/Loader exposures:The APVMA used the PHED model 3 (mixer/loader mixing liquid formulations byopen pour methods) as the most appropriate estimation method for predicting dermaland inhalation exposures. The predicted dermal exposure rates on head, body and handswere respectively 0.0116, 0.6622 and 6.248 mg a.i./kg handled.Dermal exposures:= amount active handled [kg] x (head/neck + clothing + hands) [mg/kg]1 kg a.i. x (0.0116 + 0.6622 + 6.248) = 6.9216 mg a.i./personThen applying the dermal absorption factor of 30%, and dividing by 70 kg b.w., thesystemic dose will be:(6.9216 x 0.30) / 70 = 2.0765 / 70 = 0.0297 mg/kg b.w.If PPE is considered to mitigate exposures, APVMA used 20% penetration of overalls(Gold & Holsclaw, 1984; Original not sighted); 10% penetration of gloves(Thongsinthusak et al., 1993; Original not sighted); and, 5% penetration of full-bodychemical resistant clothes (Thongsinthusak et al., 1993; Original not sighted):With overalls and gloves (protection factors applied to the body areas covered):[1 x {0.0116 + (0.6622 x 0.2) + (6.248 x 0.1)} x 0.3] / 70 = (0.7688 x 0.3) / 70 =0.2307 / 70 = 0.0033 mg/kg b.w.With full-body chemical resistant clothes and gloves:[1 x {(0.0116 x 0.05) + (0.6622 x 0.05) + (6.248 x 0.1)} x 0.3] / 70 = (0.6585 x 0.3) / 70= 0.1976 / 70 = 0.0028 mg/kg b.w.Inhalation exposures:Dichlorvos reassessment – application Page 363 of 436

The APVMA considered that the predicted rate of inhalation exposure from PHEDmodel 3 would be significantly underestimated for dichlorvos due to its high volatility.Utilising data from one study (Gold & Holcslaw, 1984; Original not sighted), theAPVMA increased the predicted rate of inhalation exposure by 50-fold to give 0.132mg a.i./kg handled.= amount active handled [kg] x inhalation exposure [mg/kg handled]1 x 0.132 = 0.132 mg a.i./personThen accepting the inhalation absorption factor of 100%, and dividing by 70 kg b.w.,the systemic dose will be:(0.132 x 1.00) / 70 = 0.0019 mg/kg b.w.If RPE is considered to mitigate exposures, APVMA used 10% penetration of half-facerespirators; 2% penetration of full-face respirators; and, no penetration of air-hoserespirators or SCBA (Thongsinthusak et al., 1993; Original not sighted):With half-face (protection factor applied):((1 x 0.132) x 0.10) / 70 = 0.0132 / 70 = 0.0002 mg/kg b.w.With full-face (protection factor applied):((1 x 0.132 x 0.02) / 70 = 0.0026 / 70 = 0.00004 mg/kg b.w.Applicator exposures:The APVMA used the data-based PHED model 19 to predict exposures duringapplication. The predicted dermal exposure rates on head, body and hands wererespectively 0.184, 26.8 and 2.55 mg a.i./kg handled, while the predicted inhalation.Dermal exposures:= amount active handled [kg] x (head/neck + clothing + hands) [mg/kg]1 kg a.i. x (0.184 + 26.8 + 2.55) = 29.534 mg a.i./personThen applying the dermal absorption factor of 30%, and dividing by 70 kg b.w., thesystemic dose will be:(29.534 x 0.30) / 70 = 8.8602 / 70 = 0.1266 mg/kg b.w.If PPE is considered to mitigate exposures, APVMA used 20% penetration of overalls(Gold & Holsclaw, 1984; Original not sighted); 10% penetration of gloves(Thongsinthusak et al., 1993; Original not sighted); and, 5% penetration of full-bodychemical resistant clothes (Thongsinthusak et al., 1993; Original not sighted):Dichlorvos reassessment – application Page 364 of 436

With overalls and gloves (protection factors applied to the body areas covered):[1 x {0.184 + (26.8 x 0.2) + (2.55 x 0.1)} x 0.3] / 70 = (5.799 x 0.3) / 70 =1.7397 / 70 = 0.0249 mg/kg b.w.With full-body chemical resistant clothes and gloves:[1 x {(0.184 x 0.05) + (26.8 x 0.05) + (2.55 x 0.1)} x 0.3] / 70 = (1.6042 x 0.3) / 70 =0.4813 / 70 = 0.0069 mg/kg b.w.Inhalation exposures:PHED model 19 predicted the inhalation exposure rate was 0.174 mg a.i./kg handled.= amount active handled [kg] x inhalation exposure [mg/kg handled]1 x 0.174 = 0.174 mg a.i./personThen accepting the inhalation absorption factor of 100%, and dividing by 70 kg b.w.,the systemic dose will be:(0.174 x 1.00) / 70 = 0.0025 mg/kg b.w.If RPE is considered to mitigate exposures, APVMA used 10% penetration of half-facerespirators; 2% penetration of full-face respirators; and, no penetration of air-hoserespirators or SCBA (Thongsinthusak et al., 1993; Original not sighted):With half-face (protection factor applied):((1 x 0.174) x 0.10) / 70 = 0.0174 / 70 = 0.0003 mg/kg b.w.With full-face (protection factor applied):((1 x 0.174) x 0.02) / 70 = 0.0035 / 70 = 0.00005 mg/kg b.w.Dichlorvos reassessment – application Page 365 of 436

Appendix 5Re-entry Worker Exposure Estimate and Risk Assessment – Out-door Crops(Example calculations for Table XII)Scenarios 1 & 2, 3c & 4c: Berries (0.8kg/ha with 1 or 2 applications per year)Re-entry by a worker for picking: dermal exposure.Assuming an application of 800g dichlorvos/ha.A working day of 8 hours is assumed.For the transfer of residues from foliage to the clothes or skin of a worker, a TC value of3000 cm 2 /hr is used (UK CRD, 2008a).A DFR value of 0.5 μg/cm 2 per kg a.s./ha applied is used (based on Casida et al., 1962in APVMA, 2008b) (See paragraphs 5.9 & 5.10).Predicted exposure for this scenario is thusD = DFR x TC x DA x WR x AR x P / BWWhere:D = Dermal Exposure [μg a.s./person*d]DFR = Dislodgeable Foliar Residue per kg a.s./ha = 0.5 μg a.s./cm² per kga.s./haTC = Transfer Coefficient [cm²/person/h] = 3000 [cm²/person/h]DA = percentage dermal absorption (30%), expressed as a fractionWR = Work Rate [8 hours/day]AR = Application Rate [0.8 kg a.s./ha]P = Penetration Factor for Clothing [= 1] which assumes one layer of ordinaryclothing is taken into accountBW = bodyweight (70 kg)Dermal Exposure (D) is 41 μg a.s./kg b.w./day.D = 0.5 x 3000 x 0.3 x 8 x 0.8 x 1 = 2880 / 7070With PPE:The German BBA Model for re-entry tasks assumes a Penetration Factor (P) for PPE as0.05 (i.e. 95% protection, given by hood/visor + overalls over long-sleeved shirt andlong-legged trousers + boots + gloves).Applying these figures to the Penetration Factor for Clothing (P) in the above equationgives the previous D x 0.05.Dichlorvos reassessment – application Page 366 of 436

The Dermal Exposure (D) is 2.06 μg a.s./kg b.w./day.Re-entry by a worker for picking: inhalation exposure.Using the data from Casida et al. (1962), 20 minutes after application to the leafsurfaces of maize, cotton and peas about 50% was volatilised, while 5% remains on theleaf surfaces and 45% absorbed by the plant (in APVMA, 2008b).It is assumed therefore that only 50% of the application rate is available for possibleinhalation:Inhalation Exposure (I) = mg a.s./hr inhaled x WR / BWmg a.s./hr inhaled = kg/a.s./ha applied x Task Specific FactorWhere:indicative Task Specific Factor = 0.01 (See paragraph 5.20);WR = Work Rate (8 hours/day)AR = Application Rate (50% of 0.8 kg a.s./ha)BW = bodyweight (70 kg)I = ((0.5 x 0.8 x 0.01) x 8) / 70 = 0.032 / 70 = 0.00046 mg/kg b.w./dayInhalation Exposure (I) is 0.00046 mg a.s./kg b.w./day or 0.46 μg a.s./kg b.w./day.With RPE:The APVMA (2008b) use the following protective factors for various RPE:Half-face respirator 0.1Full-face 0.02Air-hosenil inhalation exposureWith a half-face respirator: I = 0.46 x 0.1 = 0.046 μg a.s./kg b.w./day;full-face:I = 0.46 x 0.02 = 0.0092 μg a.s./kg b.w./day;Dichlorvos reassessment – application Page 367 of 436

Appendix 6Resident Exposures to Dichlorvos, and Risk Assessment:Exposure through contact with spray drift contaminated surfaces―It is possible that spray drift fallout from applications may be deposited in privategardens adjacent to treated areas, and individuals in such locations may becomeexposed through contact with such deposits. A possible scenario that illustrates asignificant opportunity for exposure would be children playing in a garden which hasbeen subject to spray drift fallout. It is possible to estimate such exposures using spraydrift fallout values used for aquatic risk assessment purposes (Rautmann et al., 2001)and the approach used by the United States Environmental Protection Agency toestimate residential exposure from contact with treated lawns (USA EPA 1998 / 1999 /2001). The exposure assessment reported … considers the scenario of a small childplaying on a lawn …For products which may be applied to crops on more than one occasion the theoreticalworse case is to consider children‘s exposure from the maximum total dose which maybe applied, i.e. to assume that there is no dissipation in foliar residues betweensuccessive treatments. This approach may be refined where data are available to refinethe estimated residues.‖ [quoted from UK CRD 2008b]The small child playing on a lawn leads to four potential exposures: dermal (skincontact); hand-to-mouth (sucking contacted fingers and thumbs); object-to-mouth(sucking contaminated objects, toys etc.); and, soil/grass ingestion by the child.Field crop (boom) sprayersScenarios (1-4): applications at 0.8 kg a.i./ha1) Children‘s dermal exposureSystemic exposures via the dermal route were calculated using the above drift falloutvalues and the following equation for boom sprayers:SE(d) = AR x DF x TTR x TC x H x DABWSE(d) = 8 x 0.01 x (0.05 x 0.05) x 5200 x 2 x 0.30 = 0.624 / 15 = 0.0416 μg/kg b.w.15Where:SE(d) = systemic exposure via the dermal routeAR = field application rate, 0.8 kg/ha = 8 μg/cm 2DF = drift fallout value, i.e. assumed average of 1% from boom sprayerapplicationsDichlorvos reassessment – application Page 368 of 436

TTR = turf transferable residues – the EPA default value of 5% was used in theestimate (US EPA, CARES Manual, 2002) modified by 5% from the Casida et al.data) (see para 6.10)TC = transfer coefficient – the standard EPA value of 5200 cm 2 /h was used for theestimateH = exposure duration for a typical day (hours) – this has been assumed to be 2hours which matches the 75th percentile for toddlers playing on grass in the EPAExposure Factors HandbookDA = percent dermal absorption (30%)BW = body weight - 15kg which is the average of UK 1995-7 Health Surveys forEngland values for males and females of 2 and 3 yrs2) Children‘s hand-to-mouth exposureHand-to-mouth exposures were calculated using turf transferable residue levels usingthe following equation for boom sprayers:SE(h) = AR x DF x TTR x SE x SA x Freq x HBWSE(h) = 8 x 0.01 x (0.05 x 0.05) x 0.50 x 20 x 20 x 2 = 0.08 / 15 = 0.0053 μg/kg b.w.15Where:SE(h) = systemic exposure via the hand-to-mouth routeAR = field application rate, 0.8 kg/ha = 8 μg/cm 2DF = drift fallout value, i.e. assumed average of 1% from boom sprayerapplicationsTTR = turf transferable residues – the EPA default value of 5% derived fromtransferability studies with wet hands was used in the estimate modified by 5%from the Casida et al. data)SE = saliva extraction factor – the default value of 50% was usedSA = surface area of the hands – the assumption used here is that 20 cm 2 of skinarea is contacted each time a child puts a hand in his or her mouth (this isequivalent to the palmer surface of three figures and is also related to the nextparameter)Freq = frequency of hand to mouth events/hour – for short term exposures thevalue of 20 events/hours is used, this is the 90th percentile of observations thatranges from 0 to 70 events/hourH = exposure duration (hours) – this has been assumed to be 2 hours whichmatches the 75th percentile for toddlers playing on grass in the EPA ExposureFactors HandbookBW = body weight - 15kg which is the average of UK 1995-7 Health Surveys forEngland values for males and females of 2 and 3 yrs3) Children‘s object-to-mouth exposureDichlorvos reassessment – application Page 369 of 436

Object to mouth exposures were calculated using turf transferable residue levels usingthe following equation for boom sprayers:Where:SE(o) = AR x DF x TTR x IgRBWSE(o) = 8 x 0.01 x (0.20 x 0.05) x 25 = 0.02 / 15 = 0.0013 μg/kg b.w.15SE(o) = systemic exposure via mouthing activityAR = field application rate, 0.8 kg/ha = 8 μg/cm 2DF = drift fallout value, i.e. assumed average of 1% from boom sprayerapplicationsTTR = turf transferable residues the default value of 20% transferability fromobject to mouth assessments was used modified by 5% from the Casida et al.data)IgR = ingestion rate for mouthing grass/day – this was assumed to be equivalentto 25cm 2 of grass/dayBW = body weight - 15kg which is the average of UK 1995-7 Health Surveys forEngland values for males and females of 2 and 3 yrs.4) Children‘s incidental ingestion of soil (US EPA, 2006b)The approach used to calculate doses that are attributable to soil ingestion is:Average Daily Oral Dose = (AR x DF) x F x IgR x SDF / BWADOD = (0.008 x (0.01 x 0.05)) x 1.0 x 100 x (6.7 x 10 -4 ) x 1000 =150.00027 / 15 = 0.00002 μg/kg b.w.Where:ADOD = oral dose on day of application (mg/kg b.w./day)AR = application rate (0.008 mg/cm 2 ); DF = 0.01 [Note: this value has beenmodified by the DF values used in the first 3 equations to reflect these spray driftsituations, and not direct turf applications.]F = fraction of residue retained on uppermost 1 cm of soil (%) (note: this is anadjustment from surface area to volume) modified by 5% from the Casida et al.data)SDF = soil density factor -- volume of soil (cm 3 ) per microgram of soil;IgR = ingestion rate of soil (mg/day)BW = body weight (kg)Assumptions:Dichlorvos reassessment – application Page 370 of 436

F = fraction of residue retained on uppermost 1 cm of soil is 100 percent based onsoil incorporation into top 1 cm of soil after application (1.0/cm)SDF = soil density factor -- volume of soil (cm 3 ) per gram of soil; to weight 6.7 x10 -4 cm 3 /mg soil)IgR - ingestion rate of soil is 100 mg/dayBW - body weight of a toddler is 15 kg5) Children‘s total exposure from applications at 0.8 kg a.i./ha:Children‘s total exposure was estimated as the sum of the dermal, hand-to-mouth,object to mouth exposures and soil ingestion, which was 0.0482 μg/kg b.w./day. Thistotal exposure represents an RQ of 0.03 (in comparison to the AOEL of 1.4 μg/kgb.w./day).Broadcast air assisted – orchard applicationsScenarios (5 & 6): applications at 2.052 kg a.i./haFor Scenarios (5 & 6), the application rate (AR) is 20.52 µg/cm 2 , which is a factor of2.565 greater than for Scenarios (1-4). In addition the DF increases to 10% from 1%,giving a total increase of 25.65 fold.Therefore if the above calculations are repeated for these Scenarios, the final outcome isthat the child‘s total estimated exposure is 1.2368 µg/kg b.w./day, and the RQ = 0.9 (incomparison to the AOEL of 1.4 μg/kg b.w./day).Scenarios (7 & 8): applications at 1.026 kg a.i./haFor Scenarios (7 & 8), the application rate (AR) is 10.26 µg/cm 2 , which is a factor of1.2825 greater than for Scenarios (1-4). In addition the DF increases to 10% from 1%,giving a total increase of 12.825 fold.Therefore if the above calculations are repeated for these Scenarios, the final outcome isthat the child‘s total estimated exposure is 0.6184 µg/kg b.w./day, and the RQ = 0.4 (incomparison to the AOEL of 1.4 μg/kg b.w./day).Dichlorvos reassessment – application Page 371 of 436

Domestic Indoor Surface ApplicationsScenarios (26 & 27): applications at 2.5 kg a.i./ha (A 600mL can contains 1.86g a.i.that covers 7.44m 2 at the recommended rate, 0.25g a.i./m 2 )1) Children‘s dermal exposureSystemic exposures via the dermal route were calculated using a 100% drift falloutvalue (assumes spray stays to the surface where it is applied and there is no dissipationbefore or during exposure) and the following equation:Where:SE(d) = AR x DF x TTR x TC x H x DABWSE(d) = 25 x 1 x 0.05 x 6000 x 8 x 0.30 = 1200 μg/kg b.w.15SE(d) = systemic exposure via the dermal route;AR = field application rate, 2.5 kg/ha = 25 μg/cm 2 ;DF = drift fallout value, i.e. assumed at 100%;TTR = transferable residues – the EPA default value of 5% was used in theestimate (US EPA, CARES Manual, 2002);TC = transfer coefficient – the standard EPA value of 6000 cm 2 /h was used for theestimate;H = exposure duration for a typical day (hours) – this has been assumed to be 8hours which matches the average time in any one indoor space;DA = percent dermal absorption (30%);BW = body weight - 15kg which is the average of UK 1995-7 Health Surveys forEngland values for males and females of 2 and 3 yrs.2) Children‘s hand-to-mouth exposureHand-to-mouth exposures were calculated using transferable residue levels using thefollowing equation:Where:SE(h) = AR x DF x TTR x SE x SA x Freq x HBWSE(h) = 25 x 1 x 0.05 x 0.50 x 20 x 20 x 2 = 33.33 μg/kg b.w.15SE(h) = systemic exposure via the hand-to-mouth route;AR = field application rate, 2.5 kg/ha = 25 μg/cm 2 ;DF = drift fallout value, i.e. assumed 100%;Dichlorvos reassessment – application Page 372 of 436

TTR = transferable residues – the EPA default value of 5% derived fromtransferability studies with wet hands was used in the estimate;SE = saliva extraction factor – the default value of 50% was used;SA = surface area of the hands – the assumption used here is that 20 cm 2 of skinarea is contacted each time a child puts a hand in his or her mouth (this isequivalent to the palmer surface of three figures and is also related to the nextparameter);Freq = frequency of hand to mouth events/hour – for short term exposures thevalue of 20 events/hours is used, this is the 90th percentile of observations thatranges from 0 to 70 events/hour;H = exposure duration (hours) – this has been assumed to be 2 hours whichmatches the 75th percentile for toddlers playing on grass in the EPA ExposureFactors Handbook;BW = body weight - 15kg which is the average of UK 1995-7 Health Surveys forEngland values for males and females of 2 and 3 yrs.3) Children‘s object-to-mouth exposureObject to mouth exposures were calculated using transferable residue levels using thefollowing equation:Where:SE(o) = AR x DF x TTR x IgRBWSE(o) = 25 x 1 x 0.20 x 25 = 8.33 μg/kg b.w.15SE(o) = systemic exposure via mouthing activity;AR = field application rate, 2.5 kg/ha = 25 μg/cm 2 ;DF = drift fallout value, i.e. assumed 100%;TTR = transferable residues the default value (for turf) of 20% transferabilityfrom object to mouth assessments was used;IgR = ingestion rate for mouthing grass/day – this was assumed to be equivalentto 25cm 2 of grass/day;BW = body weight - 15kg which is the average of UK 1995-7 Health Surveys forEngland values for males and females of 2 and 3 yrs.4) Children‘s incidental ingestion of soil (US EPA, 2006b)This was not seen to be relevant for the indoor uses.5) Children‘s total exposure from applications at 2.5 kg a.i./ha:Dichlorvos reassessment – application Page 373 of 436

Children‘s total exposure was estimated as the sum of the dermal, hand-to-mouth andobject to mouth exposures, which was 1.2417 mg/kg b.w./day. This total exposurerepresents an RQ of 887 (in comparison to the AOEL of 0.0014 mg/kg b.w./day).Domestic Outdoor Surface ApplicationsScenarios (28 & 29): are also applications at 2.5 kg a.i./ha, but contaminated soilingestion (due to overspray or drift) is also possible.So, in addition to the estimated exposure of children above:4) Children‘s incidental ingestion of soil (US EPA, 2006b)The approach used to calculate doses that are attributable to soil ingestion is:Average Daily Oral Dose = (AR x DF) x F x IgR x SDF / BWADOD = (0.025 x 1) x 1.0 x 100 x (6.7 x 10 -4 ) x 1000 = 0.1117 μg/kg b.w.15Where:ADOD = oral dose on day of application (mg/kg b.w./day)AR = application rate (0.025 mg/cm 2 ); DF = 1;F = fraction of residue retained on uppermost 1 cm of soil (%) (note: this is anadjustment from surface area to volume);SDF = soil density factor -- volume of soil (cm 3 ) per microgram of soil;IgR = ingestion rate of soil (mg/day);BW = body weight (kg).Assumptions:F = fraction of residue retained on uppermost 1 cm of soil is 100 percent based onsoil incorporation into top 1 cm of soil after application (1.0/cm);SDF = soil density factor -- volume of soil (cm 3 ) per gram of soil; to weight 6.7 x10 -4 cm 3 /mg soil);IgR - ingestion rate of soil is 100 mg/day;BW - body weight of a toddler is 15 kg.5) Children‘s total exposure from applications at 2.5 kg a.i./ha:Children‘s total exposure was estimated as the sum of the dermal, hand-to-mouth,object to mouth exposures and soil ingestion, which was 1.2428 mg/kg b.w./day. Thistotal exposure represents an RQ of 888 (in comparison to the AOEL of 0.0014 mg/kgb.w./day).Dichlorvos reassessment – application Page 374 of 436

Public Space ApplicationsScenario (30): applications at 1 kg a.i./ha, with contaminated soil ingestion (due tooverspray or drift) is also possible.1) Children‘s dermal exposure (UK CRD)SE(d) = 10 x 1 x 0.05 x 5200 x 2 x 0.30 = 104 μg/kg b.w.152) Children‘s hand-to-mouth exposure (UK CRD)SE(h) = 10 x 1 x 0.05 x 0.50 x 20 x 20 x 2 = 13.33 μg/kg b.w.153) Children‘s object-to-mouth exposure (UK CRD)SE(o) = 10 x 1 x 0.20 x 25 = 3.33 μg/kg b.w.154) Children‘s incidental ingestion of soil (US EPA, 2006b)ADOD = (0.010 x 1) x 1.0 x 100 x (6.7 x 10 -4 ) x 1000 = 0.0447 μg/kg b.w.155) Children‘s total exposure from applications at 1.0 kg a.i./ha:Children‘s total exposure was estimated as the sum of the dermal, hand-to-mouth,object to mouth exposures and soil ingestion, which was 0.1207 mg/kg b.w./day. Thistotal exposure represents an RQ of 86 (in comparison to the AOEL of 0.0014 mg/kgb.w./day).Dichlorvos reassessment – application Page 375 of 436

Last PageDichlorvos reassessment – application Page 376 of 436

ERMA New Zealand‟s comment on the Occupational Exposure report.Given the extremely complex nature of the overall use pattern of dichlorvos, in order toprovide a simple overview of the human health exposure results ERMA New Zealand hasproduced a plot of risk quotients for mixing, loading and application lifecycle stages for eachof the individual Use Scenarios.Each Use Scenario comprises of a range of variables, including application rates, differinglevels of PPE, etc. Each combination of variables has been assigned a ‗Chart Number‘,which must be cross referenced with the key provided after the summary plot in order todetermine the corresponding Use Scenario.The chart is drawn on a logarithmic scale. The x-axis intercepts the y-azis at an RQ value of1, which indicates that values below the x axis are viewed as negligible risk. RQs above thex-axis (i.e. RQ > 1) relates to a non-negligible risk.Dichlorvos reassessment – application Page 377 of 436

Risk QuotientDichlorvos Mixing Loading and Application Scenarios10001001011 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54Chart Number0.1Dichlorvos reassessment – application Page 378 of 436

Enclosed SpaceAgricultural UseOutdoor Agricultural UseAll assessments for this scenariohave unacceptable RQsSome but not all assessments for thisscenario have unacceptable RQsAll assessments for thisScenario have acceptable RQsReport Scenario Groupand NumberScenarios 1-4boom sprayer withengineering controlsScenarios 1-4boom sprayer withoutengineering controlsScenarios 5 & 6Broadcast air assistedsprayer withengineering controlsScenarios 5 & 6Broadcast air assistedsprayer withoutengineering controlsScenarios 7 & 8,Hand-held sprayer withhydraulic nozzles,High level targetChartNumberRQ1 2.82 3.63 4.74 5.45 5.76 83Crop/UseBerries,vegetables,cerealsMethod of Application and ControlsEquipment Details ControlsHigh or lowboomMechanical transfer, enclosed filtered cab, A1P2 + gloves formixing/loading, overalls + boots+ gloves for applicationEnclosed filtered cab,A1P2 + gloves for mixing/loadingMechanical transfer, A1P2 + hood/visor + overalls + boots + glovesfor applicationA1P2+gloves for mixing/loading, A1P2 + hood/ visor + overalls +boots + gloves for applicationGloves for mixing/loading, hood/visor + overalls + boots + glovesfor applicationGloves for mixing/loading, gloves for applicationFormulationApplicationrate7 218 No PPE 18 7Mechanical transfer system, enclosed filtered cab, A1P2 + glovesfor mixing/loading, overalls + boots + gloves for application9 8 Fine-medium droplets Enclosed filtered cab, A1P2 + gloves for mixing/loadingECMechanical transfer system, A1P2 + hood/visor + overalls+ boots10 27+ gloves for applicationFruitA1P2+gloves for mixing/loading, A1P2 + hood/ visor + overalls +11 28 (tamarillo, Airblastboots + gloves for applicationpersimmons)Gloves for mixing/loading, hood/visor + overalls + boots + gloves12 32for application2052g a.i./ha 8 ha 113 547Gloves for mixing/loading, gloves for application14 702 No PPE15 11A1P2+gloves for mixing/loading, A1P2 + hood/ visor + overalls +boots + gloves for applicationGloves for mixing/loading, hood/visor + overalls + boots + gloves16 15Hand-heldPassion fruitfor applicationsprayerGloves for mixing/loading, gloves for application17 10418 774 No PPEScenarios 9 & 10, five 19 8.3 GlasshouseGloves for mixing/loadingExposure only at RTU7L RTU cylinderscrops20 2.1 Fogging cylinder connection & Air-hose/SCBA respirator + gloves for mixing/loadingScenarios 9 & 10, one 21 1.7 Automatic/ disconnectionGloves for mixing/loadingMushroom35L RTU cylinder22 0.6 remoteHalf-face respirator + gloves for mixing/loadingroomsScenarios 11 & 12 23 9.8applicationA1P2 + gloves for mixing/loadingExposure only atScenarios 13 & 14 24 0.8mixing/loadingA1P2 + gloves for mixing/loadingScenarios 15 & 16 25 4Glasshouseflowerproduction(Cymbidiumsp.)ManualapplicationExposure at mixing,loading and applicationA1P2 + gloves for mixing/loading, A1P2 + hood/visor +overalls +boots + gloves for applicationRTU gasECArea orvolumetreated800 g a.i./ha 20 haNo. ApplicationsModelled1026 g a.i./ha 1 ha 13 25000 m30.05 g a.i./m(1 ha)1300 g a.i./ha1800 g a.i./ha.01 ha(2500 m 3 )0.2 ha(5000 m 3 )111111111Dichlorvos reassessment – application Page 379 of 436

Open SpacePublic SpaceManual FoggingApplicationsEnclosedSpaceDomestic UseEnclosed Space Industrial UseReport Scenario Groupand NumberScenarios 17 & 18, one7L RTU cylinderScenarios 17 & 18, two7L RTU cylindersScenario 19Scenario 20 & 21Scenarios 22 & 23Scenarios 24 & 25Scenarios 26-27surface applicationScenarios 28-29Surface/creviceChartNumberRQCrop/UseMethod of Application and ControlsEquipment Details ControlsFormulationApplicationrate26 1.7FoggingGloves for mixing/loading375 m 3Exposure only at RTU27 0.6 Automatic/Half-face respirator for mixing/loading 3750 m 3cylinder connection &28 1.1 remoteHalf-face respirator + gloves for mixing/loading 12500 m 3disconnection29 0.9 applicationFull-face RPE + gloves 12500 m 330 0.8Half-face respirator + gloves for mixing/loading, no PPE for375 m 3applicationHalf-face respirator + gloves for mixing/loading, full-face RPE +RTU gas 0.05 g a.i./m 3 3750 m 3131 1.9chem. resistant full body + boots + gloves for applicationFoggingExposure at mixing, Half-face respirator + gloves for mixing/loading, air hose RPE +3750 m 332 0.1Manualloading and application chem. resistant full body + boots + gloves for applicationapplicationFull-face respirator + gloves for mixing/loading, full-face RPE +12500 m 333 6chem. resistant full body + boots + gloves for application34 1.2Full-face respirator + gloves for mixing/loading, air hose RPE +12500 m 3chem. resistant full body + boots + gloves for application35 0.1375 m 336 1.2 Fogging0.05 g a.i./m 3 3750 m 337 3.9 Automatic/ Exposure only at12500 m 3A1P2 + gloves for mixing and loading38 0.4remote mixing/loading375 m 3139 3.6 application0.15 g a.i./m 3 3750 m 3404190.1Industrial usepest controlA1P2 + gloves for mixing/loading, half-face RPE + overalls+ glovesfor application12500 m 3375 m 342 1.3A1P2 + gloves for mixing/loading, air-hose RPE + chem.. resistant0.05 g a.i./m 3 3750 m 3full-body + boots + gloves for applicationA1P2 + gloves for mixing/loading, air-hose RPE + chem.. resistant12500 m 343 4.2Fogging Exposure atfull-body + boots + gloves for applicationManual mixing/loading andA1P2 + gloves for mixing/loading, half-face RPE + overalls+ gloves44 0.5application applicationEC375 m 3for application145 3.8A1P2 + gloves for mixing/loading, air-hose RPE + chem.. resistant0.15 g a.i./m 3 3750 m 3full-body + boots + gloves for application46 13A1P2 + gloves for mixing/loading, air-hose RPE + chem.. resistant12500 m 3full-body + boots + gloves for application47 0.4Half-face RPE + chem.. resistant full-body + boots + gloves for0.1 g a.i./m 2 150 m 2mixing, loading and applicationAir hose RPE + chem.. resistant full-body + boots + gloves for0.1 g a.i./m 2 1500 m 248 2High Exposure atmixing, loading and applicationpressure mixing/loading andAir hose RPE + chem.. resistant full-body + boots + gloves for0.1 g a.i./m 2 2500 m 249 4hand wand applicationmixing, loading and application150 0.7Air hose RPE + chem.. resistant full-body + boots + gloves for2 150 m20.3 g a.i./mmixing, loading and application51 4.9 Domestic use52 109 Domestic useRTU gascan surfaceapplicationRTU spraymixesExposure only duringapplicationExposure only duringapplicationArea orvolumetreatedNo. ApplicationsModelledNone RTU gas 0.25 g a.i./m 2 7.44 m 2 1None RTU spray 0.3 g a.i./m 2 60 m 2 1Scenario 3053 754 7Open SpacePublic SpaceFoggingManualapplicationExposure duringmixing/loading andapplicationHalf-face respirator + chem. resistant full-body + boots + glovesfor mixing, loading and applicationAir hose RPE + chem. resistant full-body + boots + gloves formixing, loading and application0.1 g a.i./m 2 1 ha 1Dichlorvos reassessment – application Page 380 of 436

Appendix H: Qualitative Descriptors for Risk/Benefit AssessmentQualitative descriptors are indicative only and they are primarily intended to be used to rankrisks and benefits for the purposes of balancing risks and costs against benefits, and so thatrisks can be prioritised for management. The ‗descriptor‘ words should not be seen in anyabsolute senses – they are simply a means of differentiating levels of significance.Assessing risks, costs and benefits qualitatively1.1. This section describes how ERMA New Zealand staff and the Authority address thequalitative assessment of risks, costs and benefits. Risks and benefits are assessed byestimating the magnitude and nature of the possible effects and the likelihood of theiroccurrence. For each effect, the combination of these two components determinesthe level of the risk associated with that effect, which is a two dimensional concept.Because of lack of data, risks are often presented as singular results. In reality, theyare better represented by ‗families‘ of data which link probability with differentlevels of outcome (magnitude).1.2. The magnitude of effect is described in terms of the element that might be affected.The qualitative descriptors for magnitude of effect are surrogate measures that shouldbe used to gauge the end effect or the ‗what if‘ element. Tables H4.1 and H4.2contain generic descriptors for magnitude of adverse and beneficial effect. Thesedescriptors are examples only, and their generic nature means that it may be difficultto use them in some particular circumstances. They are included here to illustratehow qualitative tables may be used to represent levels of adverse and beneficialeffect.Table H4.1 Magnitude of adverse effect (risks and costs)Descriptor Examples of descriptions - AdverseMinimalMinorModerateMild reversible short term adverse health effects to individuals in highly localised areaHighly localised and contained environmental impact, affecting a few (less than ten)individuals members of communities of flora or fauna, no discernible ecosystem impactLocal/regional short-term adverse economic effects on small organisations (businesses,individuals), temporary job lossesNo social disruptionMild reversible short term adverse health effects to identified and isolated groupsLocalised and contained reversible environmental impact, some local plant or animalcommunities temporarily damaged, no discernible ecosystem impact or species damageRegional adverse economic effects on small organisations (businesses, individuals) lastingless than six months, temporary job lossesPotential social disruption (community placed on alert)Minor irreversible health effects to individuals and/or reversible medium term adversehealth effects to larger (but surrounding) community (requiring hospitalisation)Measurable long term damage to local plant and animal communities, but no obviousspread beyond defined boundaries, medium term individual ecosystem damage, no speciesdamageMedium term (one to five years) regional adverse economic effects with some nationalimplications, medium term job lossesSome social disruption (e.g. people delayed)Dichlorvos reassessment – application Page 381 of 436

MajorMassiveSignificant irreversible adverse health effects affecting individuals and requiringhospitalisation and/or reversible adverse health effects reaching beyond the immediatecommunityLong term/irreversible damage to localised ecosystem but no species lossMeasurable adverse effect on GDP, some long term (more than five years) job lossesSocial disruption to surrounding community, including some evacuationsSignificant irreversible adverse health effects reaching beyond the immediate communityand/or deathsExtensive irreversible ecosystem damage, including species lossSignificant on-going adverse effect on GDP, long term job losses on a national basisMajor social disruption with entire surrounding area evacuated and impacts on widercommunityTable H4.2 Magnitude of beneficial effect (benefits)Descriptor Examples of descriptions - BeneficialMinimalMinorModerateMajorMassiveMild short term positive health effects to individuals in highly localised areaHighly localised and contained environmental impact, affecting a few (less than ten)individuals members of communities of flora or fauna, no discernible ecosystem impactLocal/regional short-term beneficial economic effects on small organisations (businesses,individuals), temporary job creationNo social effectMild short term beneficial health effects to identified and isolated groupsLocalised and contained beneficial environmental impact, no discernible ecosystemimpactRegional beneficial economic effects on small organisations (businesses, individuals)lasting less than six months, temporary job creationMinor localised community benefitMinor health benefits to individuals and/or medium term health impacts on larger (butsurrounding) community and health status groupsMeasurable benefit to localised plant and animal communities expected to pertain tomedium termMedium term (one to five years) regional beneficial economic effects with some nationalimplications, medium term job creationLocal community and some individuals beyond immediate community receive socialbenefit.Significant beneficial health effects to localised community and specific groups in widercommunityLong term benefit to localised ecosystem(s)Measurable beneficial effect on GDP, some long term (more than five years) job creationSubstantial social benefit to surrounding community, and individuals in wider community.Significant long term beneficial health effects to the wider communityLong term, wide spread benefits to species and/or ecosystemsSignificant on-going effect beneficial on GDP, long term job creation on a national basisMajor social benefit affecting wider communityDichlorvos reassessment – application Page 382 of 436

1.3. The likelihood applies to the composite likelihood of the end effect, and not either tothe initiating event, or any one of the intermediary events. It includes:the concept of an initiating event (triggering the hazard), andthe exposure pathway that links the source (hazard) and the area ofimpact (public health, environment, economy, or community).1.4. Thus, the likelihood is not the likelihood of an organism escaping, or the frequencyof accidents for trucks containing hazardous substances, but the likelihood of thespecified adverse effect 9 resulting from that initiating event. It will be a combinationof the likelihood of the initiating event and several intermediary likelihoods 10 . Thebest way to determine the likelihood is to specify and analyse the complete pathwayfrom source to impact.1.5. Likelihood may be expressed as a frequency or a probability. While frequency isoften expressed as a number of events within a given time period, it may also beexpressed as the number of events per head of (exposed) population. As aprobability, the likelihood is dimensionless and refers to the number of events ofinterest divided by the total number of events (range 0-1).Table H4.3 LikelihoodDescriptor DescriptionHighly improbableVery unlikelyUnlikely(occasional)LikelyHighly likelyAlmost certainly not occurring but cannot be totally ruled outConsidered only to occur in very unusual circumstancesCould occur, but is not expected to occur under normal operating conditionsA good chance that it may occur under normal operating conditionsAlmost certain, or expected to occur if all conditions met1.6. Using the magnitude and likelihood tables a matrix representing a level ofrisk/benefit can be constructed.1.7. In the example shown in Table H4.4, four levels of risk/benefit are allocated: A(negligible), B (low), C (medium), and D (high). These terms have been used toavoid confusion with the descriptions used for likelihood and magnitude, and toemphasise that the matrix is a tool to help decide which risks/benefits require furtheranalysis to determine their significance in the decision making process.1.8. For negative effects, the levels are used to show how risks can be reduced by theapplication of additional controls. Where the table is used for positive effects it mayalso be possible for controls to be applied to ensure that a particular level of benefitis achieved, but this is not a common approach. The purpose of developing thetables for both risk and benefit is so that the risks and benefits can be compared.910The specified effect refers to scenarios established in order to establish the representative risk, and may beas specific as x people suffering adverse health effects, or y% of a bird population being adversely affected.The risks included in the analysis may be those related to a single scenario, or may be defined as acombination of several scenarios.Qualitative event tree analysis may be a useful way of ensuring that all aspects are included.Dichlorvos reassessment – application Page 383 of 436

Table H4.4Level of riskMagnitude of effectLikelihood Minimal Minor Moderate Major MassiveHighly improbable A A A B BVery unlikely A A B B CUnlikely A B B C CLikely B B C C DHighly likely B C C D DDichlorvos reassessment – application Page 384 of 436

Appendix I: Data from which classifications derived by mixturerules were derivedComposition of dichlorvos formulationsName/CodeMaximum Concentration(% w/w)Emulsifiableconcentratecontaining1000 g/litredichlorvosEmulsifiableconcentratecontaining1140 g/litredichlorvosAerosolcontaining 50g/kgdichlorvosFlammableaerosolcontaining 3.1g/litredichlorvosand 8.7 g/litrepropoxurReady to useliquidcontaining 4.4g/litredichlorvosand 9.6 g/litrepropoxurDDVPInsecticideStripJ72.03Dichlorvos 70.7 82.6 5 0.45 0.45 22 24Propoxur 1.3 1A 15B 6.9 14C 0.14D 95 95E 47F 24G 19H 8.2I 79J 8.4K 7L 18M 5.1N 1 +N 2 0.059N 3 0.44N 4 0.0076N 5 0.0038N 6 0.036N 7 0.0065N 8 0.041N 9 0.1N 10 4.7N 11 0.0049O 0.07P +Q 52Dichlorvos reassessment – application Page 385 of 436

Toxicity and environmental data on which classifications were basedEndpoint Units * Dichlorvos Propoxur A B C D E F G H I J KAcute toxicity – oralAcute toxicity- dermalAcute toxicity –inhalationIf classified(mg/kg bw/d)If classified(mg/kg bw/d)If classified(mg/kg bw/d)46.4 23.5 4840 2590 1086 N/A 3600 ND N/A N/A No 300 180075 800 No 2830 ND No No ND ND ND No 210 ND0.447 0.654 ND ND ND No No ND No No No 2.21 NDSkin irritation Classification 6.3B No No 6.3B 6.3A No 6.3B 6.3B No No No 6.3B 6.3BEye irritation Classification 6.4A 6.4A 6.4A 6.4A 8.3A No 6.4A ND No No No 6.4A 8.3ASensitization Classification 6.5B No ND ND No No No ND ND ND No No NDMutagenicity Classification 6.6B No ND ND No No ND ND ND ND No No NDCarcinogenicity Classification 6.7B 6.7B ND ND ND No ND ND ND No No ND NDReproductive toxicity Classification No No 6.8A ND No No No ND No ND No No NDTarget organ toxicity Classification 6.9A 6.9A No ND No No ND ND No No No No NDAquatic toxicity Classification (MF) 9.1A (10000) 9.1D 9.1A(1)9.1B 9.1D No No 9.1B No No No No 9.1BBioaccumulation Yes/No No No No No No No No Yes No No N/A No YesRapidly biodegradable Yes/No Yes No Yes No Yes No Yes No Yes Yes N/A Yes YesSoil toxicity Classification (MF) 9.2B 9.2B No ND No No No ND ND ND No ND 9.2A(1)Soil DT50>30 d Yes/No No Yes Yes No No No No Yes No No N/A Yes YesVertebrate toxicity Classification (MF) 9.3A(1)9.3A(10)No No 9.3C No No ND N/A N/A No 9.3B 9.3CInvertebrate toxicity Classification (MF) 9.4A 9.4A ND ND ND No ND ND ND ND No ND NDDichlorvos reassessment – application Page 386 of 436

Endpoint Units * Dichlorvos Propoxur A B C D E F G H I J K(10) (1)Endpoint Units * L M N 1N 2 N 3 N 4 N 5 N 6 N 7 N 8 N 9 N 10 N 11 O P QAcute toxicity –oralAcute toxicitydermalAcute toxicity –inhalationIf classified(mg/kg bw/d)If classified(mg/kg bw/d)If classified(mg/kg bw/d)No No ND ND No 500 2000 No 2000 650 No No 500 No No NoNo No ND ND ND ND ND ND ND ND ND No 1100 ND ND NoND ND ND ND ND ND ND ND ND ND ND ND ND No ND NDSkin irritation Classification No No ND ND ND 8.2B No ND No No No 6.3B 8.2C No No NoEye irritation Classification No No ND ND ND 8.3A No ND No No No No 8.3A No No NoSensitization Classification No ND ND ND 6.5B No ND ND ND 6.5B No No ND No ND NoMutagenicity Classification No ND ND ND ND No No ND No No ND No ND No No NDCarcinogenicity Classification No ND ND ND ND No No ND No No ND No ND No ND NDReproductivetoxicityTarget organtoxicityAquatic toxicityClassification ND ND ND ND ND No No ND No No No No 6.8B ND No NDClassification No ND ND ND No ND No ND No 6.9B No ND 6.9B ND No NoClassification(MF)9.1A(1)ND ND ND 9.1A(1)9.1A(10)No 9.1D No 9.1D ND 9.1B 9.1C No No NoBioaccumulation Yes/No No Yes Yes Yes Yes Yes No Yes No Yes Yes Yes Yes No No NoRapidlybiodegradableSoil toxicityYes/No Yes No No No No No Yes Yes Yes No No Yes No No No NoClassification(MF)ND ND ND ND ND 9.2C ND ND ND ND ND ND 9.2C ND No NoSoil DT50>30 d Yes/No No Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes No Yes YesDichlorvos reassessment – application Page 387 of 436

Endpoint Units * L M N 1N 2 N 3 N 4 N 5 N 6 N 7 N 8 N 9 N 10 N 11 O P QVertebratetoxicityInvertebratetoxicityClassification(MF)Classification(MF)No ND ND ND ND 9.2C 9.3C No ND 9.3C No No 9.3C No No NoND ND ND ND ND ND ND ND ND ND ND ND ND ND ND No* MF – multiplication factor if 9.XADichlorvos reassessment – application Page 388 of 436

Toxicity mixture calculationsSubclass 6.1 Acute toxicity - additivity formula1.1 Using the additivity formula from the ERMA New Zealand User Guide to HSNOThresholds and Classifications the mixture LD 50 calculation for acute oral, dermaland inhalation toxicity for dichlorvos formulations was calculated as follows:Calculated mixture LD 50 =%ComponentLD Component50100Subclass 6.3 Skin Irritation and Subclass 8.2 Skin corrosion1.2 The mechanism for assigning skin irritation/corrosion classification to mixtures(assuming product data are not available) is by analysis of component data, asdescribed in the ERMA New Zealand User Guide to Thresholds and Classification,Table 11.3, Part V, Chapter 11, Page 10. The relevant mixture rules based on thecomposition and hazard profile of the dichlorvos formulations are:1. ∑ 8.2X components ≥ 5%, classify as 8.2X2. ∑ 8.2X components ≥1 but < 5%, classify as 6.3A3. ∑ (10 x 8.2X components) + 6.3A components ≥ 10%, classify as 6.3A.4. ∑ (10 x 8.2X components) + 6.3A components ≥ 1 but < 10%, classify as 6.3B.5. ∑ (10 x 8.2X components) + 6.3A components + 6.3B components ≥ 10%,classify as 6.3B.6. ∑ 6.3A components ≥ 10%, classify as 6.3A.7. ∑ 6.3A components ≥ 1% but < 10%, classify as 6.3B8. ∑ 6.3B components ≥ 10%, classify as 6.3B.Subclass 6.4 Eye Irritation and Subclass 8.3 Eye Corrosion1.3 The mechanism for assigning eye irritation/corrosion classification to mixtures(assuming product data are not available) is by analysis of component data, asdescribed in the ERMA New Zealand User Guide to Thresholds and Classification,Table 12.3, Part V, Chapter 12, Page 12. The relevant mixture rules based on thecomposition and hazard profile of the dichlorvos formulations are:1. ∑ 8.3A components ≥ 3% classify as 8.3A2. ∑ 8.3A components ≥ 1% but > 3%, classify as 6.4A3. ∑ (10 x x8.3A components) + 6.4A components ≥ 10%, classify as 6.4A.4. ∑ 6.4A components ≥ 10%, classify as 6.4A.Dichlorvos reassessment – application Page 389 of 436

Ecotoxicity mixture calculationsSubclass 9.1 – Aquatic Ecotoxicity - Summation method1.4 Apply summation method for classification of mixtures for aquatic ecotoxicity (referERMA New Zealand User Guide to HSNO Thresholds and Classifications, Part VI,Chapter 19, page 20):Level 1: 9.1A x MIf ≥25%, then 9.1ALevel 2:Level 3:(M x 10 x 9.1A) + 9.1BIf ≥25%, then 9.1B*(M x 100 x 9.1A) + (10 x 9.1B) + 9.1CIf ≥25%, then 9.1C*Level 4: 9.1A + 9.1B + 9.1C + 9.1DIf ≥25%, then 9.1D* If a mixture is classified as 9.1B or 9.1C and the weighted sum of components that are notrapidly degradable or are bioaccumulative is < 25% then the mixture is assigned theclassification at the step below, ie 9.1B reduces to 9.1C, and 9.1C to 9.1D.Level 1:< ≥ 25% NOT 9.1ALevel 2:< ≥25% NOT 9.1BLevel 3:< ≥25% NOT 9.1CLevel 4:< ≥25% NOT 9.1DSubclass 9.2 – Soil Ecotoxicity - Summation method1.5 Apply summation method for classification of mixtures for soil ecotoxicity (referERMA New Zealand User Guide to HSNO Thresholds and Classifications, Part VI,Chapter 20, Page 10):Level 1:9.2A x M If ≥25%, then 9.2ALevel 2:(M x 10 x 9.2A) + 9.2BIf ≥25%, then 9.2BLevel 3:(M x 100 x 9.2A) + (10 x 9.2B) + 9.2CIf ≥25%, then 9.2C*Level 4:9.2A + 9.2B + 9.2C + 9.2DIf ≥25%, then 9.2D* unless the weighted sum of components with DT >30 days (or no data on degradation) is

Subclass 9.3 –Ecotoxicity to terrestrial vertebrates - Summation method1.6 Apply summation method for classification of mixtures for terrestrial vertebratesecotoxicity (refer ERMA New Zealand User Guide to HSNO Thresholds andClassifications, Part VI, Chapter 21, Page 9):Level 1:9.3A x M If ≥25%, then 9.3ALevel 2:(M x 10 x 9.3A) + 9.3BIf ≥25%, then 9.3BLevel 3:(M x 100 x 9.3A) + (10 x 9.3B) + 9.3CIf ≥25%, then 9.3CLevel 1:< ≥ 25% NOT 9.3ALevel 2:< ≥25% NOT 9.3BLevel 3:< ≥25% NOT 9.3CSubclass 9.4 –Ecotoxicity to terrestrial invertebrates - Summation method1.7 Apply summation method for classification of mixtures terrestrial invertebrates (referERMA New Zealand User Guide to HSNO Thresholds and Classifications, Part VI,Chapter 22, Page 7):Level 1:9.4A x M If ≥25%, then 9.4ALevel 2:(M x 10 x 9.4A) + 9.4BIf ≥25%, then 9.4BLevel 3:(M x 100 x 9.4A) + (10 x 9.4B) + 9.4CIf ≥25%, then 9.4CLevel 1:< ≥ 25% NOT 9.4ALevel 2:< ≥25% NOT 9.4BLevel 3:< ≥25% NOT 9.4CDichlorvos reassessment – application Page 391 of 436

Appendix J: Current ControlsHSNO Act controls1.1 The controls applicable to dichlorvos and its formulations are given in Table J.1.The control codes, as given in Table J.1, are codes ERMA New Zealand hasassigned to enable easy cross-referencing to the regulations. These codes aredetailed in ERMA New Zealand (2001).1.2 Where a control has been changed from the default wording specified in the HSNORegulations, this is indicated by a star (*) next to the control code. The detail of thischange, including deletion of a control, is listed under Changes to Controls in TableJ.2.Dichlorvos reassessment – application Page 392 of 436

Table J.1:Existing controls for dichlorvos and its formulationsSubstanceHSNO Control Dichlorvos Ready touse liquidcontaining4.4 g/ldichlorvos& 9.6 g/lpropoxurClass 1 to 5controlsClass 6, 8and 9controlsEmulsifiableconcentratecontaining 1000g/l dichlorvosAerosolcontaining50 g/kgdichlorvosEmulsifiableconcentratecontaining1140 g/ldichlorvosFlammableaerosolcontaining3.1 g/ldichlorvosand 8.7 g/lpropoxurDDVPinsecticidestrip(a) (b) (c) (d) (e) (f) (g) (h)F1 F2 F3 F4 f F5 F6 F11 F12 F14 fF16T1 b c d e f g h T2 x g h T3 x hT4 T5 T6 a x b c d e f g h T7 x hE1 a b c d e f x g E2 c f x g x hJ72.03Dichlorvos reassessment – application Page 393 of 436

PackagingcontrolsDisposalcontrolsEmergencymanagementcontrolsApprovedHandlercontrolsE3 x hE5 x hE6 x hE7 a x b c d e f g h P1 P3 P13 a c e P14 P15 PG1 PG2 PG3 PS4 D2 D4 D5 D6 D7 x hD8 EM1 EM2 eEM6 x hEM7 x hEM8 EM9 EM10 EM11 EM12 a b c e f g EM13 AH1 h Dichlorvos reassessment – application Page 394 of 436

TrackingcontrolsIdentification controlsTR1 x b x f h I1 I2 I3 I5 I8 I9 I10 I11 h I13 I16 h I17 I18 I19 I20 I21 I22 I23 I25 I28 I29 I30 Dichlorvos reassessment – application Page 395 of 436

Controlsrelating toStationaryContainerSystems,SecondaryContainmentandUnintendedIgnition ofFlammableSubstancesCompressedGas ControlsGN35A f CG Key: Control applied nx nControl applied but varied for substance “n” (refer to Code description)Control not triggeredControl triggered but deleted by variation for substance “n” (refer to Code description) Control not triggered because of proposed change of classification of substanceDichlorvos reassessment – application Page 396 of 436

Table J.2:Summary of default controls applicable to dichlorvos (variations apply to thecorresponding substance (a) to (h)).Hazardous Substances (Classes 1 to 5 Controls) Regulations 2001Code F1 Reg 7 General test certification requirements for hazardoussubstance locationsCode F2 Reg 8 Restrictions on the carriage of flammable substances onpassenger service vehiclesCode F3 Reg 55 General limits on flammable substancesCode F4 Reg 56 Approved handler/security requirements for certainflammable substancesvariation:fChanges to Default ControlRegulation 56 of the Hazardous Substances (Classes 1 to5 Controls) Regulations 2001The following regulation is inserted immediately afterregulation 56:56A Exception to approved handler requirement fortransportation of packaged pesticides(1) Regulation 56 is deemed to be complied with if:(a) when this substance is being transported on land—(i) by rail, the person who drives the rail vehicle that istransporting the substance is fully trained in accordancewith the approved safety system for the time beingapproved under section 6D of the Transport ServicesLicensing Act 1989; and(ii) other than by rail, the person who drives, loads, andunloads the vehicle that is transporting the substance has acurrent dangerous goods endorsement on his or her driverlicence; and(iii) in all cases, Land Transport Rule: Dangerous Goods1999 (Rule 45001) is complied with; or(b) when this substance is being transported by sea, one ofthe following is complied with:(i) Maritime Rules: Part 24A – Carriage of Cargoes –Dangerous Goods (MR024A):(ii)International Maritime Dangerous Goods Code; or(c) when this substance is being transported by air, Part92 of the Civil Aviation Rules is complied with.(2) Subclause (1)(a)—(a) does not apply to a tank wagon or a transportablecontainer to which the Hazardous Substances (TankDichlorvos reassessment – application Page 397 of 436

Hazardous Substances (Classes 1 to 5 Controls) Regulations 2001Wagons and Transportable Containers) Regulations 2004applies; but(b) despite paragraph (a), does apply to an intermediatebulk container that complies with chapter 6.5 of the UNModel Regulations.(3) Subclause (1)(c)—(a) applies to pilots, aircrew, and airline ground personnelloading and managing this substance within an aerodrome;but(b) does not apply to—(i) the handling of this substance in any place that is notwithin an aerodrome; or(ii) the loading and managing of this substance for thepurpose of aerial spraying or dropping.(4) In this regulation, UN Model Regulations means the13th revised edition of the Recommendation on theTransport of Dangerous Goods Model Regulations,published in 2003 by the United Nations.Code F5 Regs 58, 59 Requirements regarding hazardous atmosphere zones forclass 2.1.1, 2.1.2 and 3.1 substancesCode F6 Regs 60 –70Requirements to prevent unintended ignition of class 2.1.1,2.1.2 and 3.1 substancesCode F11 Reg 76 Segregation of incompatible substancesCode F12 Reg 77 Requirement to establish a hazardous substance locations ifflammable substances are presentCode F14 Reg 81 Test certification requirements for facilities where class2.1.1, 2.1.2 or 3.1 substances are presentvariation:fChanges to Default ControlRegulation 81 of the Hazardous Substances (Classes 1 to5 Controls) Regulations 2001A hazardous substance location does not require a testcertificate if—(a) the hazardous substance location is situated on a farmof not less than 4 hectares; and(b) the combined quantity of each class 3.1B or class 3.1Csubstance and any petrol, aviation gasoline, or racinggasoline stored at the location is less than 2,000 litres; and(c) either—(i)the following requirements are complied with:(A) each substance is stored in 1 or more secure containers,each of which has a capacity of less than 250 litres; and(B) each container complies with regulation 11 andSchedule 2 of the Hazardous Substances (Packaging)Regulations 2001; andDichlorvos reassessment – application Page 398 of 436

Hazardous Substances (Classes 1 to 5 Controls) Regulations 2001(C) each container is—(1) situated not less than 15 metres from any area of highintensity land use or area of regular habitation; and(2) situated either in the open or in a well-ventilatedbuilding; and(3) in a compound or located so that any spillage of thesubstance will not endanger any building, or flow into anystream, lake, or natural water; or(ii) the following requirements are complied with:(A) each substance is stored in an above ground stationarytank that complies with the Stationary Container Controls inSchedule 8 of the Hazardous Substances (Dangerous Goodsand Scheduled Toxic Substances) Transfer Notice 2004, asamended by this Schedule; and(B) each of the above ground stationary tanks is situated—(1) not less than 20 metres from any area of high-intensityland use or area of regular habitation; and(2) 6 metres from any combustible materials; and(3) in a compound or located so that any spillage of thesubstance will not endanger any building, or flow into anystream, lake, or natural water.Code F16 Reg 83 Controls on transit depots where flammable substances arepresentHazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001Code T1 Regs 11 –27Limiting exposure to toxic substances through the setting ofTolerable Exposure Limits (TELs)note:b, c, d, e,f, gnote:gRegulations 11-27 of the Hazardous Substances (Classes6, 8, and 9 Controls) Regulations 2001No TELs are set at this time.Regulations 11-27 of the Hazardous Substances (Classes6, 8, and 9 Controls) Regulations 2001The following ADE is set:ADE (dichlorvos) = 0.004 mg/kg bw/dayvariation:hRegulations 11-27 of the Hazardous Substances (Classes6, 8, and 9 Controls) Regulations 2001The following TEL is set:For component A: TEL AIR 0.002 ppm.Code T2 Regs 29, 30 Controlling exposure in places of work through the settingof WESs.variation:gChanges to Default ControlsRegulations 29, 30 of the Hazardous Substances (Classes6, 8, and 9 Controls) Regulations 2001The properties and use profile of DDVP Insecticide Stripsare such that the criteria under Regulation 29(1)(c) are notmet and this control is deleted.Dichlorvos reassessment – application Page 399 of 436

Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001hRegulations 29, 30 of the Hazardous Substances (Classes6, 8, and 9 Controls) Regulations 2001The following WES applies:Component A (skin*): 8 Hour Time WeightedAverage 0.1ppm / 0.90 mg/m 3*The default excursion of three times the WES (0.3ppm/0.27 mg/m 3 ) for any 15 minute period applies.Code T3 Regs 5(1), 6 Requirements for keeping records of useCode T4 Reg 7 Requirements for equipment used to handle substancesvariation:Changes to Default Controlsh Regulation 7 of the Hazardous Substances (Classes 6, 8,and 9 Controls) Regulations 2001The comtrol imposed by this regulation is only applicableduring the manufacturing stage of the substance‘s lifecycle.Code T5 Reg 8 Requirements for protective clothing and equipmentCode T6 Reg 9 Approved handler/security requirements for certain toxicsubstancesvariation:Changes to Default Controlsb Regulation 9 of the Hazardous Substances (Classes 6, 8,and 9 Controls) Regulations 2001Regulation 9 is omitted. You do not need to be an approvedhandler to use this substance.f Regulation 9 of the Hazardous Substances (Classes 6, 8,and 9 Controls) Regulations 2001This regulation applies to each hazardous substancedescribed inSchedule 1 with variation code 3 as if subclause (1) wereomitted andthe following substituted:(1) A hazardous substance to which this regulation appliesmust be under the personal control of an approved handlerwhen the substance is used by a commercial contractor.g Regulation 9 of the Hazardous Substances (Classes 6, 8,and 9 Controls) Regulations 2001Regulation 9 only applies during the use phase of thelifecycle.h Regulation 9 of the Hazardous Substances (Classes 6, 8,and 9 Controls) Regulations 2001Regulation 9 only applies during the manufacturing andtransport phases of the lifecycle.a, c, d, e,hRegulation 9 of the Hazardous Substances (Classes 6, 8,and 9 Controls) Regulations 2001The following regulation were inserted immediately afterregulation 9:9A Exception to approved handler requirement forDichlorvos reassessment – application Page 400 of 436

Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001transportation of packaged class 6 substances(1) Regulation 9 is deemed to be complied with if—(a) in the case of a hazardous substance being transported onland—(i) in the case of a hazardous substance being transported byrail, the person who drives the rail vehicle that is transportingthe substance is fully trained in accordance with an approvedsafety system under section 6D of the Transport ServicesLicensing Act 1989 or a safety system which is referred to inan approved safety case under the Railways Act 2005; and(ii) in every other case, the person who drives, loads, andunloads the vehicle that is transporting the substance—(A) for hire or reward, or in quantities which exceed those setout in Schedule 1 of the Land Transport Rule 45001/1:Dangerous Goods 2005, has a current dangerous goodsendorsement on his or her driver licence; or(B) in every other case, the Land Transport Rule 45001/1:Dangerous Goods 2005 is complied with; or(b) in the case of a hazardous substance being transported bysea, one of the following is complied with:(i) Maritime Rules: Part 24A – Carriage of Cargoes –Dangerous Goods (MR024A); or(ii) International Maritime Dangerous Goods Code; or(c) in the case of a hazardous substance being transported byair, Part 92 of the Civil Aviation Rules is complied with.(2) Subclause (1)(a)—(a) does not apply to a tank wagon or a transportable containerto which the Hazardous Substances (Tank Wagons andTransportable Containers) Regulations 2004 applies; but(b) despite paragraph (a), does apply to an intermediate bulkcontainer that complies with chapter 6.5 of the UN ModelRegulations.(3) Subclause (1)(c)—(a) applies to pilots, aircrew, and airline ground personnelloading and handling a hazardous substance within anaerodrome; but(b) does not apply to the storage and handling of a hazardoussubstance in any place that is not within an aerodrome orwithin an aerodrome by non-airline ground personnel.The following regulation was inserted immediately afterregulation 9A:9B Exception to approved handler requirement for aerialapplication of certain substancesRegulation 9 is deemed to be complied with if, in the case ofthe aerial application of a hazardous substance, the personwho carries out the application has a current pilot chemicalrating in accordance with Part 61 of the Civil Aviation Rules.Code T7 Reg 10 Restrictions on the carriage of toxic or corrosive substanceson passenger service vehiclesvariation:Changes to Default ControlsThis regulation applies to this substance, as if each item inSchedule 2 of the regulations relatingto the specified hazard classification was replaced by:Hazard Classification Liquid (L) Solid (kg)6.5B 1 3Dichlorvos reassessment – application Page 401 of 436

Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001Code E1 Regs 32–45 Limiting exposure to ecotoxic substances through the settingof Environmental Exposure Limits (EELs)variation:a, b, c, d,e, fChanges to Default ControlsRegulations 32 to 45 of the Hazardous Substances(Classes 6, 8, and 9 Controls) Regulations 2001No EELs are set at this time, and the default EELs givenunder regulation 32 are deleted.gRegulations 32 to 45 of the Hazardous Substances(Classes 6, 8, and 9 Controls) Regulations 2001The requirements to set EELs have been deleted for thissubstance.hRegulations 32 to 45 of the Hazardous Substances(Classes 6, 8, and 9 Controls) Regulations 2001The following EEL water is set:For component A: EEL water = 0.001 μg/LCode E2 Regs 46 –48variation:gRestrictions on use of substances in application areasChanges to Default ControlsRegulations 46 to 48 of the Hazardous Substances(Classes 6, 8, and 9 Controls) Regulations 2001The requirement to set a maximum application rate has beendeleted for this substance.Code E3 Reg 49 Controls relating to protection of terrestrial invertebrates egbeneficial insectsCode E5 Regs 5(2), 6 Requirements for keeping records of useCode E6 Reg 7 Requirements for equipment used to handle substancesCode E7 Reg 9 Approved handler/security requirements for certain ecotoxicsubstancesvariation:Change to Default Controlsa Regulation 9 of the Hazardous Substances (Classes 6, 8,and 9 Controls) Regulations 2001This regulation applies as if dichlorvos is not a class 9substance.b Regulation 9 of the Hazardous Substances (Classes 6, 8,and 9 Controls) Regulations 2001The regulations apply as if regulation 9 were omitted.f Regulation 9 of the Hazardous Substances (Classes 6, 8,and 9 Controls) Regulations 2001Regulation 9(1) is replaced by:(1) This substance must be under the personal control ofan approved handler when the substance is—(a) used by a commercial contractor; or(b) applied directly onto or into water.Dichlorvos reassessment – application Page 402 of 436

Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001g Regulation 9 of the Hazardous Substances (Classes 6, 8,and 9 Controls) Regulations 2001Regulation 9 only applies during the use phase of thelifecycle.h Regulation 9 of the Hazardous Substances (Classes 6, 8,and 9 Controls) Regulations 2001Regulation 9 only applies during the manufacturing andtransport phases of the lifecycle.c,d, e, h Regulation 9 of the Hazardous Substances (Classes 6, 8,and 9 Controls) Regulations 2001Regulations 9A and 9B added (see Code T6).Hazardous Substances (Packaging) Regulations 2001Code P1 Regs 5, 6,7(1), 8General packaging requirementsCode P3 Reg 9 Criteria that allow substances to be packaged to a standard notmeeting Packing Group I, II or III criteriaCode P13 Reg 19 Packaging requirements for toxic substancesvariation:Changes to Default Controlsa, c, e This regulation applies as if ―Schedule 1‖ in subclause (1)(a)were omitted and substituted with ―Schedule 2‖ (i.e. CodePG2 is applied instead of Code PG1).Code P14 Reg 20 Packaging requirements for corrosive substancesCode P15 Reg 21 Packaging requirements for ecotoxic substancesCode PG1 Schedule 1 Packaging requirements equivalent to UN Packing Group ICode PG2 Schedule 2 Packaging requirements equivalent to UN Packing Group IICode PG3 Schedule 3 Packaging requirements equivalent to UN Packing Group IIICode PS4 Schedule 4 Packaging requirements as specified in Schedule 4Hazardous Substances (Disposal) Regulations 2001Code D2 Reg 6 Disposal requirements for flammable substancesCode D4 Reg 8 Disposal requirements for toxic and corrosive substancesCode D5 Reg 9 Disposal requirements for ecotoxic substancesCode D6 Reg 10 Disposal requirements for packagesCode D7 Regs 11, 12 Information requirements for manufacturers, importers andsuppliers, and persons in chargeCode D8 Regs 13, 14 Documentation requirements for manufacturers, importers andsuppliers, and persons in chargeDichlorvos reassessment – application Page 403 of 436

Hazardous Substances (Personnel Qualifications) Regulations 2001Code AH1 Regs 4 – 6 Approved Handler requirements (including test certificate andqualification requirements)Hazardous Substances (Tracking) Regulations 2001Code TR1 Regs 4(1), 5, 6 General tracking requirementsvariation:Changes to Default Controlsb, f Regulations 4 to 6 of the Hazardous Substances (Tracking)Regulations 2001Regulations 4 to 6 are deleted.ghRegulations 4 to 6 of the Hazardous Substances (Tracking)Regulations 2001Regulations 4 to 6 only apply to users of the substance.Regulations 4 to 6 of the Hazardous Substances (Tracking)Regulations 2001Regulations 4 to 6 only apply to while the substance is in NewZealand.Hazardous Substances (Emergency Management) Regulations 2001Code EM1 Regs 6, 7, 9 –11Level 1 information requirements for suppliers and persons inchargeCode EM2 8(a) Information requirements for corrosive substancesCode EM6 Reg 8(e) Information requirements for toxic substancesCode EM7 Reg 8(f) Information requirements for ecotoxic substancesCode EM8 Regs 12- 16,18- 20Level 2 information requirements for suppliers and persons inchargeCode EM9 Reg 17 Additional information requirements for flammable andoxidising substances and organic peroxidesCode EM10 Regs 21 – 24 Fire extinguisher requirementsCode EM11 Regs 25 – 34 Level 3 emergency management requirements: duties ofperson in charge, emergency response plansCode EM12 Regs 35 – 41 Level 3 emergency management requirements: secondarycontainmentvariation:Change to Default Controlsa, b, c, e, f, g Regulations 35- 42 of the Hazardous Substances(Emergency Management) Regulations 2001The following subclauses are added after subclause (3) ofregulation 36:(4) For the purposes of this regulation, and regulations 37 to40, where this substance is contained in pipework that isinstalled and operated so as to manage any loss ofcontainment in the pipework it—(a) is not to be taken into account in determiningwhether a place is required to hav a secondarycontainment system; and(b) is not required to be located in a secondarycontainment system.(5) In this clause, pipework—Dichlorvos reassessment – application Page 404 of 436

(a) means piping that—(i) is connected to a stationary container; and(ii) is used to transfer a hazardous substance into orout of the stationary container; and(b) includes a process pipeline or a transfer line.The following subclauses are inserted at the end ofregulation 37:(2) If the pooling substance is held in a place aboveground in containers each of which has a capacityof 60 litres or less,—(a) if the place‗s total pooling potential is less than20,000 litres, the secondary containment systemmust have a capacity of at least 25% of that totalpooling potential:(b) if the place‗s total pooling potential is 20,000 ormore, the secondary containment system must havea capacity of the greater of—(i) 5% of the total pooling potential; or(ii) 5,000 litres.(3) Pooling substances to which subclause (2) applies,must be segregated where appropriate to ensure thatthe leakage of one substance may not adverselyaffect the container of another substance.The following subclauses are inserted at the end ofregulation 38:(2) If the pooling substance is held in a place above groundin containers one or more of which has a capacity of morethan 60 litres but none of which have a capacity of more than450 litres,—(a) if the place‗s total pooling potential is less than 20,000litres, the secondary containment system must have acapacity of either 25% of that total pooling potential or110% of the capacity of the largest container, whichever isthe greater:(b) if the place‗s total pooling potential is 20,000 litres ormore, the secondary containment system must have acapacity of the greater of—(i) 5% of the total pooling potential; or(ii) 5,000 litres.(3) Pooling substances to which subclause (2)applies, must be segregated where appropriate toensure that the leakage of one substance may notadversely affect the container of another substance.Code EM13 Reg 42 Level 3 emergency management requirements: signageDichlorvos reassessment – application Page 405 of 436

Hazardous Substances (Identification) Regulations 2001Code I1 Regs 6, 7, 32–35, 36(1) – (7)Code I2Identification requirements, duties of persons in charge,accessibility, comprehensibility, clarity and durabilityCode I3 Reg 9 Priority identifiers for ecotoxic substancesCode I5 Reg 11 Priority identifiers for flammable substancesCode I8 Reg 14 Priority identifiers for toxic substancesCode I9 Reg 18 Secondary identifiers for all hazardous substancesCode I10 Reg 19 Secondary identifiers for corrosive substancesCode I11 Reg 20 Secondary identifiers for ecotoxic substancesCode I13 Reg 22 Secondary identifiers for flammable substancesCode I16 Reg 25 Secondary identifiers for toxic substancesnote:hRegulations 25 of the Hazardous Substances(Identification) Regulations 2001If the cylinders of J72.03 are labelled and marked inaccordance with the labelling or marking required by• Land Transport Rule 45001: Dangerous Goods 2005; or• Civil Aviation Rule 92: Carriage of Dangerous Goods; or• Maritime Rule 24A: Carriage of Cargoes - DangerousGoods;they do not need to comply with the secondary identifierrequirements of regulations 20 and 25 of the HazardousSubstances (Identification) Regulations 2001.Code I17 Reg 26 Use of generic namesvariation:hChange to Default ControlsRegulations 26 of the Hazardous Substances(Identification) Regulations 2001This regulation does not apply to inner packaging ofJ72.03 contained within multiple packaging.Code I18 Reg 27 Requirements for using concentration rangesvariation:hChange to Default ControlsRegulations 27 of the Hazardous Substances(Identification) Regulations 2001This regulation does not apply to inner packaging ofJ72.03 contained within multiple packaging.Code I19 Regs 29 – 31 Additional information requirements, including situationswhere substances are in multiple packagingCode I20 Reg 36(8) Durability of information for class 6.1 substancesCode I21 Regs 37- 39,47- 50General documentation requirementsCode I22 Reg 40 Specific documentation requirements for corrosive substancesCode I23 Reg 41 Specific documentation requirements for ecotoxic substancesCode I25 Reg 43 Specific documentation requirements for flammablesubstancesCode I28 Reg 46 Specific documentation requirements for toxic substancesDichlorvos reassessment – application Page 406 of 436

Code I29 Regs 51, 52 Signage requirementsCode I30 Reg 53 Advertising corrosive and toxic substancesHazardous Substances (Tank Wagon and Transportable Containers) Regulations 2004Controls for Stationary Container Systems, Secondary Containment and UnintendedIgnition of Flammable Substances (GN35A)The controls relating to stationary container systems, secondary containment and unintendedignition of flammable substances, as set out in Schedules 8, 9 and 10 respectively of theHazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice2004 (Supplement to the New Zealand Gazette, 26 March 2004, No. 35, page 767), asamended, shall apply to this substance, notwithstanding clause 1(1) of Schedules 8 and 9 andclause 1 of Schedule 10.variation:Schedule 10 of the Hazardous Substances (Dangerous Goods andScheduled Toxic Substances) Transfer Notice 2004f Clause 1 This clause applies as if the words ―every class 2 and every class3.1 hazardous substance described in Schedule 1‖ was replaced by:‖this substance‖.Clause 33 This clause applies as if the words ―Subject to subclause (2)‖ insubclause (1) were omitted.This clause applies as if subclause (2) were omitted.Table J.3:Additional controls for dichlorvosAdditional controls for dichlorvos1 Prohibition on use of dichlorvos(1) No person may use dichlorvos for any purpose other than—(a) for research and development; or(b) as an ingredient or component in the manufacture of another substance orproduct.(2) Despite subclause (1)(a), research and development using dichlorvos does notinclude investigation or experimentation in which the substance is discharged,laid or applied in or to the outdoor environment.2 Specification of pesticide and veterinary medicine actives(1) Any person who—(a) manufactures or imports into New Zealand dichlorvos, which that personhas not previously manufactured or imported on or before 1 July 2006; or(b) had previously manufactured or imported a hazardous substance listed inTable 1 of Schedule 1 on or before 1 July 2006, but that person has sincemodified the manufacturing process or changed the source of manufacturefor that hazardous substance, must provide to the Authority in writing theinformation required by subclauses (3) and (4).(2) The information required by subclause (1) must be provided—(a) in the case of a substance that is manufactured in New Zealand prior tothat substance being sold to another person or used in accordance withclause 1 of Schedule 3; or(b) in the case of a substance that is imported into New Zealand, prior to thatsubstance being imported; and(c) in the case of a substance to which subclause (1)(b) applies—(i) each and every time the manufacturing process or source ofmanufacture is changed; and(ii) include equivalent information for the substance that was producedby the manufacturing process before it was modified, or suppliedDichlorvos reassessment – application Page 407 of 436

y the previous source of manufacture, if such information has notpreviously been provided to the Authority.(3) The information to be provided is—(a) the name and address of the manufacturer of the substance;(b) the specification of the substance including either—(i) the full name, including relevant citation, of the national and/orinternational standard(s) set by an international scientific orregulatory body recognised by the Authority with which thesubstance complies, and evidence to support this; or (ii) themanufacturer‘s specifications including purity of the hazardoussubstance, isomeric ratio where applicable, maximum impuritycontent and evidence to support these, including details ofanalytical methods used. Where the substance is produced at morethan one manufacturing site, this information must be provided foreach site separately;(c) the identity of any impurity, its origin, and the nature of its relationship todichlorvos when the impurity is present at a concentration of 10 g/kg ormore;(d) the identity of any impurity that is known to be of toxicological concern,its origin, and the nature of its relationship to dichlorvos when theimpurity is present at a concentration of less than 10 g/kg.(4) Information on an impurity that is required under subclause (3) must include—(a) its chemical name;(b) its Chemical Abstract Service Registry number (if available); and(c) its maximum concentration in the substance.Table J.4:Additional controls for dichlorvos-containing substancesAdditional controls for dichlorvos-containing substanacesApplication Onto or Into Water (b, c, d, e, f, g)The substance may not be applied onto or into water, where water means water in all itsphysical forms, whether flowing or not, and whether over or under ground, but does notinclude water in any form while in a pipe, tank or cistern.Use Restriction (g)DDVP Insecticide Strip shall only be imported by the Ministry of Agriculture and Forestry andshall only be used in outdoor insect traps for the fruit fly surveillance programme.Active Ingredient Concentration Restriction (g)The size of each DDVP Insecticide Strip shall be restricted to 2.6 g with a total dichlorvoscontent no greater than 22% by weight.Export-only Restriction (h)Approval of J72.03 is limited to manufacture for export only..Dichlorvos reassessment – application Page 408 of 436

Non-HSNO Act controlsAgricultural Compounds and Veterinary Medicines Act 19971.3 Before they can be used, formulations meeting the definition of ―agriculturalcompound‖ under the Agricultural Compounds and Veterinary Medicines Act 1997,must be approved by the Agricultural Compounds and Veterinary Medicines Group(ACVM Group) of the New Zealand Food Safety Authority. The relevant currentregistrations for dichlorvos formulations are:Table J.5:Agricultural Compounds and Veterinary Medicines Group conditionsfor dichlorvos formulationsRegistrationnumberTrade NameDate ofRegistrationRegistrantP001132 Nuvos 14-03-1968 Orion CropProtection LtdP005877ArmourCrop-Insecticide (DDVP)31-01-2002 BOC LimitedP006080 Divap 07-06-2002 United PhosphorusLtdP007362DDVP InsecticideStrip12-10-2005 Biosecurity NewZealand1.4 The ACVM Group imposes controls (referred to as conditions) on the use ofsubstances under the ACVM Act. A set of generic conditions are applied (ACVM2010) to substances. Additionally, the following specific conditions have been set byACVM Group for all dichlorvos formulations.Dichlorvos reassessment – application Page 409 of 436

Table J.6:Agricultural Compounds and Veterinary Medicines Group conditions fordichlorvos formulationsACVM Conditions and ObligationsCondition 2Condition 3Condition 8DescriptionThe product must be manufactured in accordance with theACVM Standard for Good Manufacturing Practice and to thechemistry and manufacturing specifications provided by theregistrant and approved as part of the registration.Plant Compound: In addition to any labelling, advertising orpromotion requirements specified in the current registration,labelling, advertising or promotion of the product mustcomply with the current ACVM - New Zealand Labellingand Advertising Guide for Plant Compounds RequiringRegistrationIf the product is used on any food producing plant or on oraround any plant not used to produce food:· other than those specified on the current registration; or· in a manner not specified in the current registration,the user must ensure that residues of any substance in theproduct that may occur in plant material produced from theplants treated, or in animal material produced from grazing ordirect feeding of the plants treated to food producing animals,do not exceed the lesser of either:· the specified residue limit in the current New Zealand(Maximum Residue of Agricultural Compounds) FoodStandard and any subsequent amendments; or· the default maximum residue limit in the current NewZealand (Maximum Residue of Agricultural Compounds)Food Standard and any subsequent amendments, when amaximum residue limit for that substance has not beenspecified.Condition 37Ongoing obligations:The registrant must provide an annual summary of adverseevents to the ACVM Group. Adverse events which haveserious implications for the continued use of the product mustbe notified immediately.The registrant must also advise the ACVM Group of any newstudies or data that contradict information previouslysupplied.Dichlorvos reassessment – application Page 410 of 436

Appendix K: Overseas regulatory actionAustraliaStatusAPVMA review ongoing, latest draft June 2008.Current usesUse% of amount usedin Australiastored grain and grain storage structures 55%industrial, commercial and domestic situations. Including abattoirs and meatworks, wineries, food warehouses, mills and empty grain siloshousehold vapour strip products 15%animal housing (dairy cattle sheds, stables, piggeries. Also poultry houses,1.8%although expected to decrease dueto pest resistancegreenhouses (thrips on ornamentals, also tomatoes, cucumbers and capsicums 1.7%26%veterinary products 0.6%Avocado trees for leafroller control

Outcome of risk assessment for formulations with an „equivalent‟ in NewZealand 11 :Product Use Further details ofuse50 g/kgaerosolIndoor: Treatment ofindustrial anddomestic premises,stored productfacilities (includingfarm machinery andsilos), greenhouses,farm machinery,storage bins. Alsomushroom housesand in plantfumigation chambers,although these usesare not included onthe product label. Theproduct is forprofessional use only,Outdoor: treatmentof farm machineryand wasp nests.Operator entersfacility to sprayusing a manualpressure gunFixed installation,which may beoperated remotelyusing a manual orprogrammed timereleaseManual, but remote,treatment of grainbins, silos andsimilar sealedstorage containersResult ofreassessmentMOE exceeded, due toexposure duringtreatment and whenchanging cylindersExposure acceptablewith controls in placeExposure acceptablewith controls in placeExposure acceptablewith controls in placeProposed actionDiscontinue this use,.Maintain use as long asoperator wears elbowlength butyl rubbergloves, chemicalresistant clothing and afull face piecerespirator and doesn‘tenter storage structurefor 4 days posttreatment(exceptglasshouses for whichrestricted entry periodis 4 h).Maintain use as long asoperator wears elbowlength butyl rubbergloves, chemicalresistant clothing and afull face piecerespirator and doesn‘tenter storage structureduring or for 4 dayspost-treatment.Maintain use providedoperators wear PPEcomprising elbowlength butyl rubbergloves, chemicalresistant clothing and afull face piecerespirator.1140 & 500g/l ECTreatment of grainAutomatic sprayingof grain onconveyorMOE exceededprimarily duringmixing/loading, sincetreatment of grain isautomatic.Discontinue this use.500 g/l EC Surface spray inhousesProfessional useonly, most likely byhand-held sprayer,knapsack sprayer,or a hand wandsupplied via a hosefrom a vehiclemountedspray tankand pump.Exposure from treatingand mixing/loadingeven one house leads toMOE exceedanceDiscontinue this use11 Dual formulations not registered in New Zealand are excluded from this table.Dichlorvos reassessment – application Page 412 of 436

Product Use Further details ofuseSurface spray in other Professional useindoor situations only, most likely byincluding animal hand-held sprayer,housing, milk and knapsack sprayer,meat processing or a hand wandfacilities,and grain supplied via a hosestorage structures from a vehiclemountedspray tankand pump.Result ofreassessmentExposure from treatingand mixing/loadingleads to MOEexceedanceProposed actionDiscontinue this useSpace spray, inindoor situationsincluding stables andpiggeries factories,stores, mills, abattoirsand wineries. tobaccostores, warehouses,and glass- andmushroom houses.Application ratesvary with location.Operators wouldprobably use a highpressure hand wandin conjunction witha vehicle-mountedspray tank andpump.Exposure from treatingand mixing/loadingleads to MOEexceedanceDiscontinue this useFog or mist stables,piggeries, abattoirs,wineries, factories,stores, mills andwarehouses tobaccostores, warehouses,glass- and mushroomhousesApplication ratesvary with location.Foggers or mistersmay be portable orstationaryEven with stationaryfoggers/misters,exposure duringmixing/loading is likelyto lead to MOEexceedanceDiscontinue this useSpace spray, fog ormist garbage dumps,beach, picnic andrecreation areasMOE exceeded atexpected work ratesDiscontinue this use inabsence of moredetailed information onwork rates/exposure.Volatilise from‗wooden boards‘ intobacco stores,warehouses,,glasshouses andmushroom housesUndiluted productis poured ontowooden boards andallowed toevaporateMOE exceeded forlarger buildingsDiscontinue this useApplication bywatering can indomestic situationsMOE exceeded atexpected work ratesDiscontinue this use inabsence of moredetailed information onwork rates/exposure.Use as a liquid baitby mixing with sugarwaterApplication eitherby surface spray orpaint brushMOE exceeded atexpected work ratesDiscontinue this useApplication to beeand wasp nestsOutdoor applicationusing low-pressurehand wandExposure acceptablewith controls in placeAcceptable if glovesand overalls wornDichlorvos reassessment – application Page 413 of 436

Product Use Further details ofuseApplication to Airblast applicationavocado trees (noother external cropuses are permitted)Result ofreassessmentMOE exceeded, alsoimpractically sizedbuffer zones to protectaquatic environmentProposed actionDiscontinue this use.Dichlorvos reassessment – application Page 414 of 436

Risk assessment identified concernsBystander: Sureguard Pest Strip Household Insecticide approval to be deleted because ofunacceptable chronic inhalation risk.Operator exposure: Amount of dichlorvos that can be safely handled in one day 1.4 kg,even using enclosed mixing systems and gloves and chemical resistant clothing. This is lessthan anticipated amount to be used for indoor/outdoor fogging/misting, broadacre applicationto avocado and mechanical application to grain.Environment: only significant oudoor agricultural use is on avocados and this should beterminated due to impractically large (>200 m) buffer zones needed to protect aquatichabitats. Lesser risk due to use on recreational areas outdoors. Require label warnings ofrisks from run-off/wash-off prior to degradation (indoor and outdoor use). Risks to birds andbees expected to be short-lived.Propose:1. Affirm the approvals of the active constituent.2. Due to the likelihood of toxicologically unacceptable levels of operator exposure, deletethe following uses of dichlorvos from product labels:Surface spray.Space spray.Crack and crevice treatment.Pressurised gas in enclosed spaces where the operator must enter the spaceunder fumigation.Portable fogging or misting equipment in enclosed spaces where the operatormust enter the space under fumigation.Watering can.Paintbrush.Outdoor and indoor application by fogging or misting.Broadacre application to avocados.Mechanical application to grain.3. Because of a lack of information on residues 12 (hence an inability to conduct a dietaryintake risk assessment), delete the following uses of dichlorvos from product labels:Application to bagged and stored potatoesApplication in mushroom housesApplication in glasshouses and greenhouses except when used for ornamentals4. Because of the likelihood of toxicologically unacceptable exposure, include arestraining statement on the label instructions to disallow the application of dichlorvosin buildings that are likely to be re-occupied within four days of fumigation, with theexception of glasshouses and similar plant production facilities.12 Not relevant to an ERMA NZ evaluation for reassessmentDichlorvos reassessment – application Page 415 of 436

5. Include in label instructions a restricted entry interval of 4 hours when dichlorvos isused for fumigation of glasshouses and similar plant production facilities.6. In order to minimise risk to terrestrial and aquatic species from direct spray or spraydrift and to reduce other risks to the environment from the use of dichlorvos, includeprecautionary statements on labels indicating risks involved in specific uses.7. Amend product labels to clearly state that dichlorvos is to be used only on stored cerealgrains, since the risks of human dietary exposure are unknown when dichlorvos isapplied to other stored grains such as pulses.8. For consistency of label instructions across dichlorvos products, amend the productlabels describing use on silos or grain silos to specify location for use as ‗empty grainsilos‘.9. As a consequence of the proposed finding of the review, continued use of or any otherdealing with the product Sureguard Pest Strip Household Insecticide (APVMA productcode 45596) is likely to have a harmful effect on human beings. The registration of thisproduct lapsed, effective from 1 July 2007. Normally a two-year sales period is allowedafter product registrations lapse. The APVMA proposes that, for Sureguard Pest StripHousehold Insecticide, the two-year sales period will be stopped at the finalisation ofthe review.If these proposals are carried through, the remaining use of dichlorvos formulations for whichthere is a New Zealand equivalent will be:Manual treatment of grain storage containers using 50 g/kg aerosol as long asoperators wear elbow length butyl rubber gloves, chemical resistant clothing and afull face piece respirator and don‘t enter storage structure during treatment or for 4days afterwards;Fogging/misting of commercial installations such as abattoirs and meat works,wineries, food warehouses, mills and empty grain silos using 50 g/kg aerosols withfixed installation equipment, provided operators wear PPE comprising elbow lengthbutyl rubber gloves, overalls and a half face piece respirator with combined gas/dustcartridge when changing cylinders and provided operators do not enter theinstallation for 4 days post-treatment;Fogging/misting of commercial glasshouses containing ornamentals using 50 g/kgaerosols with fixed installation equipment, provided operators wear PPE comprisingelbow length butyl rubber gloves, overalls and a half face piece respirator withcombined gas/dust cartridge when changing cylinders and provided operators do notenter the installation for 4 hours post-treatment;Outdoor use of 50 g/kg aerosol to treat farm machinery or wasp nests as long asoperator wears elbow length butyl rubber gloves, chemical resistant clothing and afull face piece respirator;Outdoor use of 500 g/l EC to treat bee or wasp nests if gloves and overalls are worn.United StatesStatusUSEPA reregistration eligibility document (RED) completed, July 2006Dichlorvos reassessment – application Page 416 of 436

Current usesFormulations:Methods of Application:Use Sites:Granules for bait, liquid, resin impregnated, ready to use spraysand foggers.Applied with ready to use aerosol spray cans, spray equipment,wall mounted foggers, and through slow release fromimpregnated materials, such as resin strips and pet collars.DDVP is registered to control insect pests in agricultural sites,commercial, institutional and industrial sites; in and aroundhomes; and on pets. DDVP is also used in greenhouses; mushroomhouses; storage areas for bulk, packaged and bagged raw andprocessed agricultural commodities; foodmanufacturing/processing plants; animal premises; and non-foodareas of food-handling establishments. It is also registered fordirect dermal pour-on treatment of cattle and poultry. DDVP is notregistered for direct use on any field or greenhouse growncommodities.Use% of amount used in UScommodities in bulk storage,54%distribution warehouses and processingplantsLivestock and poultry 28%Pest control operator/structural use 15%In the US, continued use is permitted as follows:Fogging glasshouses not containing food commodities.Remote fogging equipment or brush-on coarse spray of mushroom houses underspecified conditions of crop development.Remote fogging or misting of food-handling establishments (including theatres, foodprocessing platns, infustrial plants and warehouses) when not in operation, providedfood is removed and food handling equipment is covered.Crack and crevice spraying in food-handling establishments.Spot treatment by spraying or paint brush and fogging or misting of non-food areasof food-handling establishments.Localised spraying in bulk food storage or manufacturing areas, provided the food isnot directly contaminated.Spraying or fogging of farm buildings;Pest strips may be used in animal buildings and milk rooms, provided food andmilking equipment is not contacted directly;Fine spray may be used to treat feed lots, stockyards etc;Specified applications direct to farm animals are permitted;Spray or fogging of outdoor public areas is permitted, although not by hand-heldfoggers.Dichlorvos reassessment – application Page 417 of 436

For each of the US permitted uses, application rates are prescribed and PPE is specified asfollows:long-sleeve shirt, long pants, shoes and socks and chemical resistant gloves for allapplications except ready to use pest strips and pet flea collars. A respirator mustalso be worn during mixing, loading and application for liquid formulations exceptready to use aerosols containing

CanadaStatusPMRA are undertaking a re-evaluation but details are not available.Current UsesNo information available.Outcome of risk assessmentLabel changes have been introduced as interim measure to reduce user exposure (PMRA,2008).These changes are intended to do the following:1. Implement measures for Canadian products that are consistent with measuresvoluntarily adopted in the United States.Discontinuation of hand-held fogger and crack and crevice applications, andimplementation of restricted entry intervals for use in mushroom houses.2. Remove uses that are not supported by the Canadian technical registrant for reevaluationby the PMRA.These uses include wineries and wine cellars, surface spray applications in dogkennels, and applications by brush or sprayer of a mixed bait to beef cattle,dairy cattle and horses.3. Increase consistency on product labels with respect to the personal protective equipment(PPE) required for similar application methods.The most restrictive PPE requirements will be adopted for all similar products,and PPE label statements will be clarified.Measures for the domestic products have already been adopted. These include a reformulationof the pest strip products and changes to use directions that restrict use to areas that aregenerally unoccupied.EUStatusUse of dichlorvos as a plant protection product is no longer permitted. Authorisations wereterminated on 6 Dec 2007 and use of existing stocks by 6 Dec 2008 (EU, 2007). Use ofdichlorvos as a biocide is to be reviewed under the Biocide Directive, but no evaluationdocumentation is available.Dichlorvos reassessment – application Page 419 of 436

Current UsesIn the past dichlorvos has been approved for use in greenhouses to combat aphid, thrips andwhitefly and in cereal and flower bulb storage to combat cereal and flower bulb pests. Priorto termination of approval under Council Directive 91/414, the notifier proposed use only forroom-treatment of flower bulbs during storage. There is no information available on use ofdichlorvos as a biocide.Outcome of risk assessmentNotifier of dichlorvos for plant protection use did not provide adequate information toconvince authorities of toxicology (concern around mutagenicity in vivo and carcinogenicity)and operator and bystander exposure.Dichlorvos reassessment – application Page 420 of 436

Appendix L: Parties consulted during the preparation of theapplicationAdria Crop Protection LimitedBayer New Zealand LimitedMAF-BNZBOC New Zealand LimitedFederated Farmers of New ZealandFonterraFoundation of Arable research (FAR)Greendale MushroomsHorticulture New ZealandMeadows MushroomsNew Zealand Flour Millers AssociationNew Zealand Grain and Seed Trade AssociationNorthern DistributorsNorthland Cymbidium Growers‘ Association IncorporatedOrion Crop Protection LimitedPest Management Association of New Zealand (PMANZ)RentokillTe Mata MushroomsZelam LimitedDichlorvos reassessment – application Page 421 of 436

Appendix M: ACVM and other NZFSA administered legislationInformation supplied by New Zealand Food Safety AuthorityNZFSA1. In September 2008 the New Zealand Cabinet agreed that NZFSA‘s mandate is toprotect consumers by providing an effective food regulatory programme that coversfood produced and consumed in New Zealand as well as imported and exported foodproducts. In pursuing this mandate the overriding priority will always be to protectconsumers.2. In delivering this mandate, NZFSA is to:engender high levels of trust and confidence in the New Zealand regulatoryprogramme covering food and related products both domestically andinternationally;base risk management decisions designed to protect consumers on sound scienceand an evidence base, applying precaution when faced with scientificuncertainty;apply the principles of openness and transparency;engage with stakeholders including consumers and industry sectors;minimise the costs of regulatory actions/interventions, recognising the economicbenefits to domestic and export food businesses and the flow-on effects inconsumer food prices;communicate food risks, hygienic practices and nutritional information as far asthese are known and relevant to the food supply and consumer behaviour;recognise that there are New Zealand customs and practices that involve thenon-commercial hunting, gathering and/or preparation of food where the publicdoes not expect regulatory intervention;utilise any capacity to improve business opportunities for domestic and exportfocussed food industries;maintain the integrity of official assurances provided to importing countries‘governments; andwork at the multilateral and bilateral level to ensure neither internationalstandards nor importing country standards pose unjustified ‗technical barriers‘ totrade.NZFSA legislative framework3. NZFSA is responsible for the administration of a number of acts and regulations.(See Appendix A for a list). The paragraphs below provide a brief summary of themain acts under which NZFSA manages risks.Agricultural Compounds and Veterinary Medicines Act 19974. The purpose of the ACVM Act is to prevent or manage specific risks associated withthe use of agricultural compounds, the definition of which includes veterinarymedicines, and to ensure that their use does not result in breaches of domestic foodresidue standards.Dichlorvos reassessment – application Page 422 of 436

Animal Products Act 19995. The purpose of this Act is to minimise and manage risks to human or animal healtharising from the production and processing of animal material and to facilitate theentry of animal material and products into overseas markets. This purpose isachieved by instituting measures and controls that ensure so far as is practicable thatall traded animal products are fit for their intended purpose.6. Under the act, NZFSA is responsible for setting and ensuring compliance withstandards for the primary processing and export of animal products including meat,game, seafood, dairy and honey.Food Act 19817. The purpose of this Act is to manage food safety risk factors inherent in theproduction, manufacture, preparation, packaging, storage, handling, transport,distribution, or sale of food that is intended for human consumption.8. The Act also provides for the setting of and monitoring of Maximum Residue Limits(MRLs) for agricultural chemicals and veterinary medicines to ensure GoodAgricultural Practice (GAP) is complied with in their use and to safeguard consumerhealth. The Act‘s provisions apply to both domestic and imported food.Wine Act 20039. This Act covers all types of wine (grape, fruit and vegetable wine), cider and mead.The purpose of the Act is:to set standards for identity, truth in labelling, and the safety of wine;to minimise and manage the risks to human health arising from the making ofwine and to ensure compliance with wine standards;to facilitate the entry of wine into overseas markets by providing the controlsand mechanisms needed to give and safeguard official assurances issued for thepurpose of enabling entry into those markets;to enable the setting of export eligibility requirements to safeguard the reputationof New Zealand wine in overseas markets.Government agencies‟ areas of responsibility in risk management10. Government policy provides the direction for managing risks posed by any substancethat could potentially cause adverse effects. Because of the need for specialistknowledge to deal with particular risks, the management of risk areas has beenplaced with different government ministries and departments, with the expectation ofclose cooperation in areas that unavoidably overlap.11. The areas of responsibility, relevant legislation, and the responsible governmentdepartment in New Zealand are:AREA OFRESPONSIBILITYPreventing theintroduction of,eradicating or controllingpests and unwantedRELEVANTLEGISLATIONBiosecurity Act1993RESPONSIBLEAGENCYBiosecurityAuthorityDichlorvos reassessment – application Page 423 of 436

organismsProviding generalassessment and imposingcontrol on hazardoussubstances*Protecting the generalpublic and theenvironment fromhazardous substances ornew organismsProtecting animal welfareAssurances for the safetyof export primary produce,food and food-relatedproductsAssurances for the safetyand suitability of domesticfood and food-relatedproductsManaging risks to publichealth, animal welfare,agricultural security, tradefrom use of agriculturalcompoundsControlling hazards in theworkplaceControlling medicines anddrugsHazardousSubstances andNew OrganismsAct 1996ResourceManagement Act1991Animal WelfareAct 1999Animal ProductsAct 1999Animal ProductsAct 1999 Food Act1981AgriculturalCompounds andVeterinaryMedicines Act 1997Health and Safetyin Employment Act1992Medicines Act 1981Misuse of DrugsAct 1975Ministry for theEnvironment,Environmental RiskManagementAuthorityMinistry for theEnvironment andTerritorial LocalAuthoritiesBiosecurityAuthorityNZ Food SafetyAuthorityNZ Food SafetyAuthorityNZ Food SafetyAuthority, ACVMGroupDepartment ofLabour,Occupational Safetyand Health ServicesMinistry of Health,NZ Medicines andMedical DevicesSafety Authority12. Collectively, all of the laws mentioned above form the statutory basis for regulatorycontrol of substances in New Zealand. In all of these areas Government policy isbased on the principles of:regulatory intervention only when it is necessary; andestablishing acceptable levels of protection from adverse effects.ACVM regulatory framework and government policy13. Adverse effects resulting from the use and/or misuse of agricultural compounds havethe potential to cause serious problems in areas ranging from human health tointernational trade. Consequently, these products are subject to strict regulatorycontrols on their importation, manufacture, sale and use.Dichlorvos reassessment – application Page 424 of 436

14. Regulatory control of these products focuses on avoiding or minimising the possibleadverse effects that may result from their use. Because of the wide range of productsand substances that are classified as agricultural compounds, the adverse effectscould be any or all of the following:harm to persons using or exposed to the compoundsharm to the health and welfare of animals treated or exposedharm to the environment in its broadest senseunacceptable primary produce for both the local and export marketunacceptable residues in foods or pharmaceutical productsintroduction of pests or unwanted organisms, or interference in pest controlprogrammes.15. The New Zealand Government has created a regulatory framework designed tomanage the risks of these adverse effects. The framework includes statutory andnon-statutory mechanisms to control substances, products, and their use.16. The basic Government policy is to impose regulatory control that is ‗necessary andsufficient‘ to manage the risks down to acceptable levels, while avoiding unnecessarycosts of compliance to New Zealand as a whole. The policy has a broad focusincluding:domestic food safetytrade in primary produce and processed foods, food-related products andpharmaceuticals to meet importing country safety requirementsanimal welfareprotection from the introduction of pests and unwanted organismsprotection of the environmentgeneral public health and safetyhealth and safety in the workplace.Operation of the ACVM Act17. The ACVM Act regulates substances used in the management of plants and animals,including agricultural chemicals, fertilisers, stock food, pet food and veterinarymedicines and the term ‗agricultural compound‘ includes all these aspects within itsdefinition. The specific risks managed under the ACVM Act are:risks to public health;risks to trade in primary produce;risks to animal welfare; andrisks to agricultural security.18. The ACVM Group has established thresholds and criteria for these risk areas. Thisforms the basis for determining the level of regulatory oversight of agriculturalcompounds and the information requirements required to support an application forregistration.19. The Act seeks to achieve its purpose by providing that no agricultural compoundmay be used in New Zealand unless that use is authorised by or under this Act. Themechanisms for authorisation are:Dichlorvos reassessment – application Page 425 of 436

egistration subject to conditions; orexempt from registration where the substance is generally recognised as safe; orapprove an agricultural compound without registration under specialcircumstances; orexemption from the requirement to register subject to prescribed conditions.20. The Act provides several mechanisms for managing the risks of the product. Theseinclude:a wide range of conditions of registration can be applied to products requiringregistration or exempt from registration. For example, they can place conditionson importation, manufacture, labelling, packaging, storage, who can sell or use.Limit the term of registrationApproval of operating plansRecognition of persons21. Registration of products (or Trade Name Products) requires the applicant to submitinformation in a range of areas so ACVM Group can determine any risks of theproduct. The main information requirements are:chemistry and manufacturingefficacytarget animal (or crop) safetyresiduesalong with a copy of the label.22. Once the information has been assessed, the risks determined, the ACVM Groupconsiders what conditions of registration are required to ensure any risks areadequately managed. In considering this, the ACVM Group is also obliged toconsider whether any other legislation can provide these controls.23. The ACVM Group maintains a public register on its website of all registeredproducts. The register contains basic information on the product and a crossreference to a scanned version of the label content.24. An important issue to remember is that some of New Zealand‘s trading partners havebanned the use of certain substances in food-producing animals. The ACVM Groupholds a list of these substances and, if unsure of the status of the substance to beused, users must check with the ACVM Group prior to any off-label use.ACVM Act relationship with other NZFSA-administeredlegislation25. There is a complex technical relationship between the ACVM Act and other Actsadministered by NZFSA (and also the Biosecurity Act, Animal Welfare Act,Medicines Act and Hazardous Substances Act which are administered by otheragencies).26. The Food Act, the Animal Products Act and the Wine Act provide required outcomesfor the protection of human health and safety in relation to food and food-relatedproducts. Standards for the management of risks to the safety and integrity of NewDichlorvos reassessment – application Page 426 of 436

Zealand‘s trade in primary produce and for official assurances/certification areprovided by the Animal Products Act and the Wine Act.27. The ACVM Act is designed to provide a ―one stop shop‖ for the assessment andmanagement of those risks as they relate to the use of agricultural compound andveterinary medicines.Food standards under the Food Act 198128. In New Zealand, MRLs are set under the Food Act as food standards, namely theNew Zealand (Maximum Residue Limits of Agricultural Compounds) FoodStandards. These Standards are amended a number of times each year to reflectchanges in the use of agricultural compounds in the production of food.29. MRLs indicate the maximum legal levels at which residues of agriculturalcompounds and veterinary medicines may be present in food for sale in NewZealand.30. MRLs are primarily a tool for monitoring the use of agricultural compounds againstgood agricultural practice (GAP). GAP is not explicitly defined or regulated, but isthe generally-accepted means of producing safe primary produce. GAP is aboutensuring that chemical residues in food are as low as practicable, withoutcompromising the ability of the chemical to successfully do what is intended.31. The MRL Standards are issued by the Minister for Food Safety under Section 11C ofthe Food Act 1981. The MRL Standards have been amended regularly since 1999,when it became the base standard for agricultural compound residues in foods as aparallel standard with regulation 257 of the Food Regulations 1984, which have sincebeen revoked. The frequency of these amendments reflects new agriculturalcompounds coming on the market and changes in the registered uses of compoundsalready available.32. NZFSA administers the MRL Standards but the final decision on any changes to theStandards rests with the Minister for Food Safety. When amending or issuing anyfood standard, including the MRL Standards, the Minister must take into account thefollowing:the need to protect public health;the desirability of avoiding unnecessary restrictions on trade;the desirability of maintaining consistency between New Zealand's foodstandards and those applying internationally;New Zealand's obligations under any relevant international treaty,agreement, convention, or protocol, and, in particular, under theAustralia-New Zealand Joint Food Standards Agreement; andsuch other matters as the Minister considers appropriate.33. In most instances, MRLs are recommended based on the assessment of the productcontaining the active ingredient under the ACVM Act. Under this Act, GAP isestablished and the residue assessment based on this GAP determines the likelyresidues in food and feed crops. Another important consideration is whether thereare any trade issues that requiring addressing with respect to residues and setting ofMRLs. This information forms the basis for setting MRLs in the New Zealand(Maximum Residue Limits of Agricultural Compounds) Food Standards.Dichlorvos reassessment – application Page 427 of 436

34. The MRLs vary from country to country depending on the pesticides available, thecrops being treated and the way the pesticides are used. Food exporters must complywith these MRLs as a condition of market access. To help New Zealand exportersmeet these market access requirements, NSFSA maintains a database of nationalpesticide MRLs from around the world that are relevant to New Zealand foodexporters.Animal Products Act 199935. The Animal Products Act provides for the setting of standards that must be met byanimal products in relation to, inter alia, composition of animal material or products;limitations or requirements in relation to ingredients or additives; microbiological orchemical status.36. The Act also provides for the specifying of requirements that must be met by animalproducts for them to be eligible for export and for requirements and systems thatsafeguard official assurances provided by New Zealand in respect of those products.37. The ACVM Act provides a mechanism to ensure animal produce complies with theAnimal Products Act requirements. Mechanisms include restricting who canauthorise to use, or sell or use products, and setting of withholding periods to ensureresidues comply with Maximum Permissible Residues in the Animal Products Act.Wine Act 200338. The Wine Act 2003 provides for the setting of standards to allow the management ofrisks to human health arising from the making of wine in order to ensure that thewine is fit for its purpose.39. Under the ACVM Act, the main mechanism to complement the Wine Act is byensuring the use of the agricultural compound in grape production will comply withMRLs.NZFSA verification and monitoring programmesImplementation of control measures40. Industry working throughout the food chain has the primary role in implementationof control measures. Nevertheless, NZFSA may be directly involved in this step inthe Risk Management Framework (RMF), such as in supervisory meat inspection.More often, the Verification Agency of NZFSA will verify control measuresimplemented by industry. The Compliance Group of NZFSA carries out anindependent audit of regulatory functions and applies sanctions where controlmeasures have not been properly implemented by industry.41. The Approvals and ACVM Group of NZFSA also carries out an implementationfunction by registering food premises and approving food safety plans developed byindustry.42. NZFSA often develops implementation tools to assist stakeholders in implementingregulatory requirements. Examples are generic codes of hygienic practice fordifferent food commodities, guidelines on quality assurance systems, accreditationsystems for laboratories, and assisting with training and education.Verification programmes43. The NZFSA Verification Agency (NZFSA VA) verifies that food safety programmesare adhered to at premises where meat, seafood and other animal products areDichlorvos reassessment – application Page 428 of 436

processed and stored. It employs veterinarians to inspect animals, ensure animalwelfare protocols are followed and provides export certification to the products.44. NZFSA VA verifies that meat, seafood and other animal products and by-productsmeet both the New Zealand standards and additional standards of importingcountries.Monitoring of the food chain by NZFSA45. The aim of monitoring by NZFSA is to gather and analyse data on the level ofcontrol of specific hazards throughout the food chain and combine this with humanhealth surveillance data to determine the effectiveness of regulatory activities. Thismay be carried out ahead of implementation of control measures so as to establishbaseline levels or it may follow their implementation. Monitoring programmescarried out by NZFSA include.National Microbiological Database for systematic and ongoing monitoring ofpremises slaughtering cattle, sheep, deer, goats, poultry and ostriches.Food Residue Surveillance Programme for compliance with chemical foodsafety standards across a wide range of foods.Total Diet Survey for evaluating the level of exposure of the New Zealandpopulation to chemicals in the food supply.National Residue Monitoring Programme for providing food safety assuranceson all animal products, including farmed and wild animals, fish and honey.NZFSA role in trade46. Government policy for food safety is developed from a New Zealand perspective, butit is influenced by international and bilateral obligations as well. These externalfactors include agreements and treaties between New Zealand and particularcountries to facilitate trade, harmonise assurance and compliance activities, andfacilitate the movement of people and goods. They also include multinationalstandards established by organisations such as the World Health Organization(WHO), Office International de Epizooties (OIE), World Trade Organization (WTO),and the Organization for Economic Cooperation and Development (OECD).47. Much of the work done by NZFSA involves negotiations with New Zealand‘s tradingpartners and plays a key role in gaining market access for New Zealand products.NZFSA works to secure market access at various levels. For example, at themultilateral level, NZFSA works with a number of international bodies. Some ofthese are:Codex Alimentarius Commission is an international body set up under theauspices of the United Nations Food and Agriculture Organization (FAO) andWHO) and charged with developing a global food code. It develops foodstandards, guidelines and related texts such as codes of practice under the JointFAO/WHO Food Standards Programme. The main purposes of this Programmeare protecting health of the consumers and ensuring fair practices in the foodtrade, and promoting coordination of all food standards work undertaken byinternational governmental and non-governmental organisations.Organisation Mondiale de la Santé Animale (OIE), whose focus is the reductionof food borne risks to human health due to hazards arising from animalproduction. NZFSA is represented on the permanent Working Group on AnimalDichlorvos reassessment – application Page 429 of 436

Production Food Safety (APFSWG) which coordinates the food safety activitiesof the OIE.International Plant Protection Convention (IPPC). New Zealand is a contractingparty to this treaty which aims to secure action to prevent the spread andintroduction of pests of plants and plant products, and to promote appropriatemeasures for their control. It is governed by the Commission on PhytosanitaryMeasures (CPM) which adopts International Standards for PhytosanitaryMeasures (ISPM).48. NZFSA‘s participation in these organisations focuses on ensuring that their rules arescience and risk-based and reflect New Zealand‘s needs.Bilateral agreements49. Bilateral arrangements are negotiated with importing countries, the aim being toalign standards or have a trading partner accept that New Zealand systems deliverresults that meet their requirements. NZFSA market access experts work to find thebest ways to meet importing requirements that are cost-effective and flexible for ourindustry.50. The Agreement on mutual recognition in relation to conformity assessments betweenthe European Community (EC) and New Zealand (98/509/EC) covers all medicinalproducts which are industrially manufactured in New Zealand and the EC and towhich Good Manufacturing Practice (GMP) requirements apply. (Medicinalproducts include all human and veterinary products).NZFSA principles for risk assessment51. Food safety is an accepted consumer requirement but one that courts controversy.The last decade has seen vastly increased knowledge on risks to consumersassociated with biological, chemical and physical hazards in the food chain, alongwith demonstrated success in the application of new regulatory systems and foodsafety programmes. Nevertheless, foodborne illness continue to be a significantproblem in all countries and governments are responding in a number of ways toassure the safety of food provided to domestic consumers and to those in offshoremarkets.52. NZFSA also has a mandate to improve business opportunities wherever practicable.This is driving closer cooperation between NZFSA and industry in identifyingpriority areas for applied research and regulatory change so as to accommodateinnovative and cost-effective technologies. Government promotion of economic,environmental and social sustainability (non-harmonised under international foodtrade agreements) also influences NZFSA domestic regulatory policies.53. NZFSA, in common with a number of other food safety regulators, uses risk analysisto answer a basic set of questions:What can go wrong?How likely is it to go wrong?How serious would it be if it went wrong?What can be done to reduce the likelihood and/or seriousness of it going wrong?54. During risk assessment, scientific judgements often entail a choice among severalreasonable options. Uncertainty is intrinsic to risk analysis and different approachesDichlorvos reassessment – application Page 430 of 436

may be taken to risk management in the face of scientific uncertainty in differentpolitical, social and economic contexts.55. In some cases, consumer fears have driven actual bans on trade even though this wasnot scientifically supported by international standard-setting processes (eg EuropeanUnion ban on importation of hormone-treated beef from all countries including NewZealand). In other cases, a conservative approach to standard setting may be takenby NZFSA if the ramifications of a single detection of a high-profile pathogen (eg E.coli O157: H7) in exported product might include a worst-case reaction from tradingpartners.56. NZFSA does not have a specific policy on application of a precautionary approach inthe face of scientific uncertainty. Rather, there is an understanding that incorporationof precaution in the RMF will be rational, practical and based on scientific principles.If there is likely to be a significant risk to human health from a particular hazard orsituation, NZFSA will take appropriate risk management action that is proportionalto: the potential risk, the consequences of the risk management option(s) chosen, andthe degree of uncertainty in the scientific evaluation.57. The regulatory response to a risk by NZFSA will prevent or limit exposure whilemore conclusive information is gained on the actual risks faced and the controlmeasures that are likely to be most effective. For products in trade, there is anobligation under the WTO SPS Agreement to actively pursue additional scientificinformation when a precautionary approach is taken, with timely review of interimcontrol measures.58. As a signatory to the World Trade Organization Agreement on the Application ofSanitary and Phytosanitary Measures (WTO SPS Agreement), New Zealand isacutely aware of its responsibilities in pursuing a risk-based and equitableinternational trading environment. Consequently, NZFSA has developed acomprehensive strategy for incorporating the risk analysis guidelines developed bythe Codex Alimentarius Commission (CAC) in its regulatory systems whereverappropriate.59. In imported food situations, the WTO SPS Agreement places specific constraints onfactors that can be included in decisions on ‗appropriate levels of protection‘ (ALOP)that are chosen by NZFSA. Decisions should take into account the minimisation oftrade effects and ensure that selected control measures are not more restrictive thannecessary to meet an ALOP. NZFSA must also avoid unjustifiable or arbitrarydistinctions in levels of ALOP chosen in different food safety situations.Dichlorvos60. There are currently four products registered under the ACVM Act that containdichlorvos:ArmourCrop-Insecticide, registration number P5877; andDDVP Insecticide Strip, registration number P7362; andDivap, registration number P6080; andNuvos, registration number P113261. Divap and Nuvos are agricultural chemical trade name products with claims for useon a range of agricultural and horticultural crops and public health uses.62. ArmourCrop-Insecticide is an agricultural chemical trade name product with a claimfor use on pepper crop.63. DDVP Insecticide Strip is an agricultural chemical trade name product with a claimfor fruit fly surveillance.Dichlorvos reassessment – application Page 431 of 436

64. Based on a Joint meeting of the FAO Working of Experts on Pesticide Residues andthe WHO Expert Committee on Pesticide Residues Acceptable Daily Intake (JMPRADI) of 0.004 mg/kgbw/day the dietary burden of dichlorvos in adults is equivalentto 93% of the ADI.65. Current controls on the products are consistent with the majority of other agriculturalchemical trade name products registered under the ACVM Act. Withholding periodsto avoid non-compliant residues are set and stated on the labels for the approveduses. There is no obligation to comply with the stated withholding periods. However,there is a statutory obligation to ensure that any residues in produce from treatedanimals or crops comply with relevant residue limits.Dichlorvos reassessment – application Page 432 of 436

Appendix A• Agricultural Compounds and Veterinary Medicines Act Commencement Order 2001 SR2001/100• Agricultural Compounds and Veterinary Medicines (Fees and Charges) Regulations 2002• Agricultural Compounds and Veterinary Medicines (Transitional Provisions) Regulations 2002• Agricultural Compounds and Veterinary Medicines Regulations 2001 SR 2001/101• Agricultural Compounds and Veterinary Medicines Act 1997• Animal Products Act 1999• Animal Products Amendment Act 2002• Animal Products (Ancillary and Transitional Provisions) Amendment Act 2002• Animal Products (Ancillary and Transitional Provisions) Amendment Act 2005• Animal Products (Regulated Control Scheme Bivalve Molluscan Shellfish) Regulations 2006• Animal Products (Regulated Control Scheme - Contaminant Monitoring and Surveillance)Regulations 2004• Animal Products Regulations 2000• Animal Products (Fees, Charges, and Levies) Regulations 2007 dated 1 July 2007• Animal Products (Regulated Control Scheme--Limited Processing Fishing Vessels) Regulations2001• Animal Products (Regulated Control Scheme-Dairy Export Quota Products) Regulations 2008• Dairy Industry Restructuring (Transfer of Export Licences)• Animal Products (Dairy) Regulations 2005• Animal Products (Dairy Industry Fees and Charges) Regulations 2007• Animal Products (Exemptions and Inclusions) Order 2000• Dairy Industry (National Residue Monitoring Programme) Regulations 2002• Food Act 1981• Food Hygiene Regulations 1974• Food (Safety) Regulations 2002• Australia New Zealand Food Standards Code• New Zealand (Maximum Residue Limits of Agricultural Compounds) Food Standards 2004• New Zealand (Milk and Milk Products Processing) Food Standards 2002• Wine Act 2003Dichlorvos reassessment – application Page 433 of 436

Appendix N: Plant & Food Research Report on UseDichlorvos reassessment – application Page 434 of 436

Appendix O: ReferencesACVM (2010) http://www.nzfsa.govt.nz/acvm/publications/information-papers/new-registrationconditions-for-agricultural-chemicals-0210.htm#P51_7319(retrieved 29 July 2010).APVMA (2008) Dichlorvos – Preliminary Review Findings Report.Barrett KL, Campbell PJ, Candolfi MP, Forster R, Grandy N, Harrison EG, Hassan S, Huet MC,Lewis G, Oomen P, Schmuck R, Voght H. (2000) Guidance document on regulatory testing on riskassessment procedures for plant protection products with non-target arthropods. From ESCORT 2Workshop SETAC-Europe.EFSA (2008). Risk assessment to birds and mammals, The EFSA Journal (2008) 734:1-181ERMA New Zealand 2008a. User Guide to HSNO Thresholds and Classifications. ERMA NewZealand, Wellington.EU (2000). EU guidance (2000): Guidance document on Persistence in soil under Council Directive91/414/EEC (9188/VI/97 rev. 8)EU (2002). Guidance Document on terrestrial ecotoxicology under Council Directive 91/414/EEC,SANCO/ 10329/2002 rev. 2 final, 2002EU (2003). Monograph prepared in the context of the inclusion of the following activesubstance in Annex 1 of the Council Directive 91/414/EEC. Dichlorvos, Vol 1, Report &Proposed Decision.EU (2005). Draft Assessment Report – Dichlorvos (public version). Initial risk assessmentreport provided by the rapporteur Member State, Italy, for the existing active substancedichlorvos, of the second stage of the review programme referred to in Article 8(2) of CouncilDirective 91/414/EEC.EU (2007). COMMISSION DECISION of 6 June 2007 concerning the non-inclusion of dichlorvos inAnnex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protectionproducts containing that substance (notified under document number C(2007) 2338) OJ L145/16.FAO/WHO (1970) Evaluations of some pesticide residues in food, dichlorvos.Horticulture NZ (2008) New Zealand Code of Practice for the Management of the Tomato/PotatoPsyllid in Greenhouse Tomato and Capsicum Crops. Edition 1.HSNO Chemical Classification Information Databasehttp://www.ermanz.govt.nz/hs/compliance/chemicals.htmlNew Zealand Standard 8409 (2004). Management of agrichemicals.NCGA (2009). The use of dichlorvos in the New Zealand Cymbidium industry. Report prepared bythe Northland Cymbidium Growers Association for submission to the Environmental RiskManagement Authority.PMRA (2008). Dichlorvos Interim Measures. Re-evaluation note. Rev 2008-04Rautmann D., Streloke M., & Winkler R. (2001). New, basic drift values in the authorizationprocedure for plant protection products. In : Forster R, Streloke M, Workshop on risk assessment andrisk mitigation measures in the context of the authorization of plant ptrotection products (WORMM).Mitt. Biol Bundesanst Land –Forstwirtsch Berlin-Dahlem 383, 133-141Dichlorvos reassessment – application Page 435 of 436

Urban D.J., Cook, N.J. (1986). Hazard Evaluation Division Standard Evaluation Procedure:Ecological Risk Assessment. EPA 540/9-85-001. United States Environmental Protection AgencyOffice of Pesticide Programs, Washington DC, USA.USEPA AgDrifthttp://www.agdrift.com/AgDRIFt2/Download.htmUSEPA SCI-GROW model Screening Concentration In Ground Waterhttp://www.epa.gov/oppefed1/models/water/scigrow_description.htmUSEPA (2001) Generic Estimated Environmental Concentration Model v2 (GENEEC2). United StatesEnvironmental Protection Agency Office of Pesticide Programs, Washington DC, USAhttp://www.epa.gov/oppefed1/models/water/index.htm#geneec2USEPA (1997) Reregistration Eligibility Decision - Trichlorfon (RED) EPA-738-R-96-017USEPA (2006) Reregistration Eligibility Decision - Dichlorvos (DDVP) EPA 738-R-06-013USEPA (2006a) Reregistration Eligibility Decision for Trichlorfon (includes the 2001 Report onFQPA Tolerance Reassessment Progress and Interim Risk Management Decision (TRED) forTrichlorfon, EPA 738-R-01-009.Dichlorvos reassessment – application Page 436 of 436