PO Box 1749 Halifax, Nova Scotia B3J 3A5, Canada

Item No. 11.1.5

Halifax Regional Council June 8, 2010

TO:

Mayor Kelly and Members of Halifax Regional Council

SUBMITTED BY:

___________________________________________________________ Wayne Anstey, Acting Chief Administrative Officer

DATE: SUBJECT:

May 18, 2010 Amendment to Administrative Order #23, Respecting Pesticides, Herbicides and Insecticides - Notice of Motion to Add FeHEDTA (for lawn use) to the Permitted Pesticides List

ORIGIN This report originates from Administrative Order 23, and staff receipt of Industry Requests for amendment.

RECOMMENDATION It is recommended that Halifax Regional Council, approve in principle the addition of FeHEDTA, for lawn use, to the Permitted Pesticides List in Administrative Order #23 and direct staff to initiate the formal legislative process.

Amendment to Administrative Order #23, Respecting Pesticides, Herbicides and Insecticides Notice of Motion to Add FeHEDTA (for lawn use) to the Permitted Pesticides List -2Council Report BACKGROUND

June 8, 2010

Administrative Order #23, Respecting Pesticides, Herbicides, and Insecticides Excluded From the Pesticide By-Law, is a companion document to the Pesticide By-Law P800, and provides a list of Permitted Pesticides that are excluded from the provisions of the Pesticide By-Law. It was approved by Regional Council in 2000. The list includes such products as Insecticidal Soaps, Bacillus Thuringgiensis, Dormant Oils, Lime Sulphur, etc. In order to facilitate the addition/deletion of substances from Administrative Order #23, staff have provided a protocol to amend the Permitted Pesticides List. This protocol has resulted in the addition of Diatomaceous Earth, Acetic Acid and, most recently (in 2005), Corn Gluten Meal.

DISCUSSION Staff have received a request from HalifaxSeed, Weedman, and Edmonds Landscaping to add FeHEDTA to the Permitted List in Administrative Order #23. What Is FeHEDTA? Iron is a metallic chemical element (symbol Fe) that acts as a selective herbicide when chelated with hydroxyethylenediaminetriacetic acid (HEDTA) to form FeHEDTA. Broadleaved plants are generally more susceptible to the herbicidal effects of FeHEDTA than are grass species. The mechanism of selectivity is not entirely understood but is believed to relate in part to differences in uptake. As Fe can function as a catalyst for oxygen reduction, thereby producing unstable and highly reactive oxygen species, including hydroxyl radicals that cause cellular damage, the excessive uptake of FeHEDTA, by many broadleaved species, leads to tissue necrosis and ultimately plant death. Attachment One is the submission (since approved) to Pesticide Management Regulatory Agency (PMRA). It provides much information on the product. Attachment Two is the PMRA Product Label. Attachment Three is the Ontario Approval. According to the Procedures to Amend the Permitted Pesticides List in Administrative Order #23, substances must satisfy the following requirements: 1. 2. Full disclosure of all ingredients of any material/ substance being considered. The material/substance must not be prohibited by OMRI (Organic Material Review Institute) in their generic names list.

Amendment to Administrative Order #23, Respecting Pesticides, Herbicides and Insecticides Notice of Motion to Add FeHEDTA (for lawn use) to the Permitted Pesticides List -3Council Report 3. 4. 5.

June 8, 2010

6.

The material/substance must not be prohibited from use in Canada. Proposed substances/materials not presently listed on OMRIs generic names list shall be referred to OMRI for review and recommendation at the cost of the applicant. Whereas advance notice to the public on Administrative Order #23 is required through brochures, newsletters, etc., it is recommended that unless there are exceptional circumstances, an annual process be completed by February 15th of each year to amend the list of Permitted Pesticides. These procedures shall be reviewed periodically by the appropriate staff to help ensure they remain up to date and effective.

Since this protocol was created in 2001, other provinces and municipalities have adopted pesticide restriction and regulations. Recently, the Province of Nova Scotia passed legislation that will mirror the Ontario Pesticide regulations which will become effective in 2011. Based on the Ontario Regulations (which the Union of Nova Scotia Municipalities) recommended the Province of Nova Scotia develop their pesticide legislation around), HRM staff are recommending support of this industry request for addition of this product to the Approved List. In reviewing the 2001 protocol, this request meets the primary requirements, with the exception of OMRI approval for the generic product. It is not specifically prohibited nor approved. Iron is approved, with restrictions for use for organic use. In addition to the above protocol, Sustainable Environment Management Office (SEMO) staff conducted basic research on the usage of the product. It appears that this product meets the intent of the HRM Pesticide By-Law and should be on the permitted list. Staff is committed to facilitating the widest possible list of acceptable permitted substances for use by HRM residents. With the recently passed Provincial Legislation Respecting Pesticides, it is anticipated and planned that HRM will no longer administer its By-Law and Administrative Order after this season.

BUDGET IMPLICATIONS There are no budget implication to this action. Existing staff resources will update the HRM literature on the internet site.

Amendment to Administrative Order #23, Respecting Pesticides, Herbicides and Insecticides Notice of Motion to Add FeHEDTA (for lawn use) to the Permitted Pesticides List -4Council Report FINANCIAL MANAGEMENT POLICIES/BUSINESS PLAN

June 8, 2010

This report complies with the Municipalitys Multi-Year Financial Strategy, the approved Operating, Project and Reserve budgets, policies and procedures regarding withdrawals from the utilization of Project and Operating reserves, as well as any relevant legislation.

ALTERNATIVES Regional Council may choose to not approve adding FeHEDTA to the Approved List.

ATTACHMENTS Attachment One: Submission to PMRA Attachment Two: Label Attachment Three: Ontario Approval

A copy of this report can be obtained online at http://www.halifax.ca/council/agendasc/cagenda.html then choose the appropriate meeting date, or by contacting the Office of the Municipal Clerk at 490-4210, or Fax 490-4208.
Report Prepared by: Richard MacLellan, Manager - SEMO, 490-6056

Financial Approval by:

___________________________________________________ Cathie OToole, CGA, Director of Finance, 490-6308

Report Approved by:

Phillip Townsend, Director, Infrastructure and Asset Management, 490-7166

(WorkbookVersion November2009)

ProposedRegistrationDecision

FeHEDTA
PMRADocumentNumber:1841244

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Overview
ProposedRegistrationDecisionforFeHEDTA
HealthCanadasPestManagementRegulatoryAgency(PMRA),undertheauthorityofthePest ControlProductsActandRegulations,isproposingfullregistrationforthesaleanduseof NEU1173HTGAIandtheenduseproducts NEU1173HRTUwithPullNSprayApplicator, NEU1173HRTUwithQuickConnectSprayer,NEU1173HRTU,FiestaLawnWeedKiller ReadytoSpray,FiestaLawnWeedKiller,NEU1173HReadytoSprayLargeSize,NEU1173H ReadytoSpray,NEU1173HLargeSize,andNEU1173H,containingthetechnicalgradeactive ingredientironpresentasFeHEDTA(hereinreferredtoasFeHEDTA),tocontrol several broadleavedweedspeciesthatcommonlyoccurinturf. Anevaluationofavailablescientificinformationfoundthat,undertheapprovedconditionsofuse, theproducthasvalueanddoesnotpresentanunacceptablerisktohumanhealthorthe environment. ThisOverviewdescribesthekeypointsoftheevaluation,whiletheScienceEvaluationprovides detailedtechnicalinformationon thehumanhealth,environmentalandvalueassessmentsof NEU1173HTGAIandtheenduseproductsNEU1173HRTUwithPullNSprayApplicator, NEU1173HRTUwithQuickConnectSprayer,NEU1173HRTU,FiestaLawnWeedKiller ReadytoSpray,FiestaLawnWeedKiller,NEU1173HReadytoSprayLargeSize,NEU1173H ReadytoSpray,NEU1173HLargeSize,andNEU1173H.

WhatDoesHealthCanadaConsiderWhenMakingaRegistrationDecision?
ThekeyobjectiveofthePestControlProductsActistopreventunacceptableriskstopeopleand theenvironmentfromtheuseofpestcontrolproducts.Healthorenvironmentalriskisconsidered 1 acceptable ifthereisreasonablecertaintythatnoharmtohumanhealth,futuregenerationsorthe environmentwillresultfromuseorexposuretotheproductunderitsproposedconditionsof 2 registration.TheActalsorequiresthatproductshavevalue whenusedaccordingtothelabel directions.Conditionsofregistrationmayincludespecialprecautionarymeasuresontheproduct labeltofurtherreducerisk. Toreachitsdecisions,thePMRAappliesmodern,rigorousriskassessmentmethodsandpolicies. Thesemethodsconsidertheuniquecharacteristicsofsensitivesubpopulationsinhumans(e.g. children)aswellasorganismsintheenvironment(e.g.thosemostsensitivetoenvironmental
1

Acceptablerisksasdefinedbysubsection2(2)ofthe PestControlProductsAct. Valueasdefinedbysubsection2(1)ofthe PestControlProductsAct:theproductsactualorpotential contributiontopestmanagement,takingintoaccountitsconditionsorproposedconditionsofregistration, andincludestheproducts(a)efficacy(b)effectonhostorganismsinconnectionwithwhichitis intendedtobeusedand(c)health,safetyandenvironmentalbenefitsandsocialandeconomicimpact.

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contaminants).Thesemethodsandpoliciesalsoconsiderthenatureoftheeffectsobservedand theuncertaintieswhenpredictingtheimpactofpesticides.Formoreinformationonhowthe PMRAregulatespesticides,theassessmentprocessandriskreductionprograms,pleasevisitthe PMRAswebsiteathealthcanada.gc.ca/pmra. Beforemakingafinalregistrationdecisionon FeHEDTA,thePMRAwillconsiderallcomments 3 receivedfromthepublicinresponsetothisconsultationdocument .ThePMRAwillthenpublish 4 aRegistrationDecision on FeHEDTA,whichwillincludethedecision,thereasonsforit,a summaryofcommentsreceivedontheproposedfinalregistrationdecisionandthePMRAs responsetothesecomments. FormoredetailsontheinformationpresentedinthisOverview,pleaserefertotheScience Evaluationofthisconsultationdocument.

WhatIsFeHEDTA?
Ironisametallicchemicalelement(symbolFe)thatactsasaselectiveherbicidewhenchelated withhydroxyethylenediaminetriaceticacid(HEDTA)toformFeHEDTA.Broadleavedplantsare generallymoresusceptibletotheherbicidaleffectsofFeHEDTAthanaregrassspecies.The mechanismofselectivityisnotentirelyunderstoodbutisbelievedtorelateinparttodifferencesin uptake.AsFecanfunctionasacatalystforoxygenreduction,therebyproducingunstableand highlyreactiveoxygenspecies,includinghydroxylradicalsthatcausecellulardamage,the excessiveuptakeofFeHEDTAbymanybroadleavedspeciesleadstotissuenecrosisand ultimatelyplantdeath.

HealthConsiderations
CanApprovedUsesof FeHEDTAAffectHumanHealth?

FeHEDTAisunlikelytoaffectyourhealthwhenusedaccordingtolabeldirections. ExposuretoFeHEDTAmayoccurwhenhandlingandapplyingtheproduct.Whenassessing healthrisks,twokeyfactorsareconsidered:thelevelswherenohealtheffectsoccurandthe levelstowhichpeoplemaybeexposed.Thedoselevelsusedtoassessrisksareestablishedto protectthemostsensitivehumanpopulation(forexample,childrenandnursingmothers).Only usesforwhichtheexposureiswellbelowlevelsthatcausenoeffectsinanimaltestingare consideredacceptableforregistration. Thetechnicalgradeactiveingredient,FeHEDTA,isoflowacutetoxicitybytheoral,dermaland

3

Consultationstatementasrequiredbysubsection28(2)ofthe PestControlProductsAct. Decisionstatementasrequiredbysubsection28(5)ofthe PestControlProductsAct.

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inhalationroutesandisminimallyirritatingtoeyes,butnonirritatingtoskin.Thereispotential forskinsensitizationtooccurwhenskinisrepeatedlyexposedtoFeHEDTAproducts.Therefore, cautionarystatementsalertinguserstothissensitizationconcernarerequiredonallproduct labels. Dermalexposureislikelyforcommercialapplicators,domesticusersoranyoneenteringsprayed areasbeforethesprayisdried.ChildrenmayalsobeexposedtoFeHEDTAbydirectdermalor handtomouthcontactiftheyweretoplayonfreshlytreatedlawnsurfaces.Therefore,a restrictedentrystatementisrequiredonallproductlabelstomitigatethisexposureconcern. Waiversweregrantedforshorttermdermaltoxicity,prenataldevelopmenttoxicityand genotoxicitystudiesbasedonthelowapplicationrates,lowdermalabsorption,lowtoxicityof FeHEDTA,andonthestrengthoftoxicologicalinformationonchemicallysimilarEDTA compounds. ResiduesinWaterandFood Dietaryrisksfromfoodandwaterarenotofconcern. EnduseproductscontainingFeHEDTA arenotapplieddirectlytofoodorfeedcrops,soresidues onfoodareexpectedtobenegligible. OccupationalRisksFromHandlingFeHEDTA OccupationalrisksarenotofconcernwhenFeHEDTAisusedaccordingtolabel directions,whichincludeprotectivemeasures. Occupationalandresidentialexposureisexpectedtobebrief,andisnotlikelytoresultin unacceptablerisktocommercialapplicators,occupationalworkers,anddomesticusersiftheend useproductsareusedaccordingtolabeldirections. Theproposeduseoftheenduseproductsmayresultinexposuretothecommercialapplicators, domesticusers,mixers,loaders,andthoseresponsibleforcleanupandmaintenanceactivities,but significantrisksfromsuchexposuresarenotanticipatedduetothelowtoxicityofFeHEDTAand adequateexposuremitigationmeasuresrecommendedonthelabels.Forbystanders,exposureis expectedtobenegligible.Therefore,healthriskstobystandersarenotofconcern. Precautionaryandhygienestatementsonthelabelsareconsideredadequatetoprotectindividuals fromanyunnecessaryriskfromoccupationalexposure.

EnvironmentalConsiderations
WhatHappensWhenFeHEDTAIsIntroducedIntotheEnvironment?
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FeHEDTAisexpectedtobenonpersistentintheenvironment(terrestrialandaquatic) underneutraltoalkalineaerobicconditions. FeHEDTAhasapotentialforhighmobility insandysoilwithnegligibleorganicmatter.FeHEDTAisexpectedtoimpactbroadleaf terrestrial plantstherefore,aprecautionarylabelstatementisneededfortheprotectionof desirableplants. Ironisubiquitousintheenvironment.FeHEDTAiswidelyusedasaplantmicronutrientfertilizer inagriculturalindustries.Basedonitslowvolatility,FeHEDTAisnotexpectedtoenterthe atmosphere.FeHEDTAissolubleinwaterwhereitisrapidlydegradedby naturallight. FeHEDTA istransformedbymicroorganismsinsoilandaquaticsystems,althoughitisrelatively stableinanaerobicsoils.Nomajorproductsareformedinsoilandwater.Fromtheproposeduse pattern,theamountofFeHEDTAenteringtheenvironmentwillbelowerthanforother agriculturaluses. FeHEDTAisexpectedtoposenegligiblerisktoterrestrialandaquaticorganismsunder conditionsofuseforapplicationtoturf.

ValueConsiderations
WhatIstheValueof FeHEDTA

FeHEDTAcontrolsseveralbroadleavedweedspeciesthatcommonlyoccurinturf.Itisan alternativetoconventional. FeHEDTA iscompatiblewithintegratedweedmanagementpractices inthatitisappliedonlywhenweedshaveemergedandisnotusedasapreventativetreatment.

MeasurestoMinimizeRisk
Labelsofregisteredpesticideproductsincludespecificinstructionsforuse.Directionsinclude riskreductionmeasurestoprotecthumanandenvironmentalhealth.Thesedirectionsmustbe followedbylaw. Thekeyriskreductionmeasuresbeingproposedonthelabelsof theenduseproducts NEU1173HRTUwithPullNSprayApplicator,NEU1173HRTUwithQuickConnectSprayer, NEU1173HRTU,FiestaLawnWeedKillerReadytoSpray,FiestaLawnWeedKiller, NEU1173HReadytoSprayLargeSize,NEU1173HReadytoSpray,NEU1173HLargeSize, andNEU1173Htoaddressthepotentialrisksidentifiedinthisassessmentareasfollows. KeyRiskReductionMeasures HumanHealth Becausethereisaconcernwithdomesticuserscomingintodirectcontactwith FeHEDTAonthehandsandthentransferringtomouth,thelabelsrecommendavoid handtomouthcontactandrequirecommercialapplicators/domesticusersandworkers
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towashhandsthoroughlywithsoapandwaterafterhandlingtheproductsandbefore eating,drinking,andchewinggumorchewingtobacco. Thelabelsspecifythatanyonehandlingorapplyingtheseproductsshouldavoidbreathing vapourorspraymistandavoidcontactwithskinorclothing.Domesticproductlabels shouldincludethestatementDONOTgetineyes. Toprotectchildren andadultsfromdermalexposuretoFeHEDTAfromwettreatedturf, thelabelsshouldincludetherestrictedentrystatement,Donotreenterorallowreentry intotreatedareasuntilthesprayisdried. ThesignalwordsPOTENTIALSKINSENSITIZERandthestatementMaycause skinsensitizationarerequiredontheprincipalandthesecondarydisplaypanels, respectively,ofboththetechnicalandenduseproductlabels. Topreventinappropriateuse,thesecondarydisplaypanelofthetechnicallabelshould includethestatementPREVENTACCESSBYUNAUTHORIZEDPERSONNEL. Personalprotectiveequipment(PPE)recommendedincludeprotectiveeyewearfor commercialproductsandwaterproofglovesforbothcommercialanddomestic productswhichrequireloading,mixing,andforrepair/cleanupactivities. Theapplicationofcommercialproductsisrecommendedonly whenthepotentialfordrift toareasofhumanhabitationorareasofhumanactivitysuchashouses,cottages,schools, andrecreationalareasisminimaltakingintoconsiderationwindspeed,winddirection, temperature,applicationequipment,andsprayersettings.

NextSteps
Beforemakingafinalregistrationdecisionon FeHEDTA,thePMRAwillconsiderallcomments receivedfromthepublicinresponsetothisconsultationdocument.ThePMRAwillaccept writtencommentsonthisproposalupto45daysfromthedateofpublicationofthisdocument. PleaseforwardallcommentstoPublications(contactinformationonthecoverpageofthis document).ThePMRAwillthenpublishaRegistrationDecision,whichwillincludeitsdecision, thereasonsforit,asummary ofcommentsreceivedontheproposedfinaldecisionandthe Agencysresponsetothesecomments.

OtherInformation
WhenthePMRAmakesitsregistrationdecision,itwillpublishaRegistrationDecisionon FeHEDTA (basedontheScienceEvaluationofthisconsultationdocument).Inaddition,thetest datareferencedinthisconsultationdocumentwillbeavailableforpublicinspection,upon
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application,inthePMRAsReadingRoom(locatedinOttawa).

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ScienceEvaluation
FeHEDTA 1.0
1.1

TheActiveIngredient,ItsPropertiesandUses
IdentityoftheActiveIngredient
Activesubstance Function Chemicalname 1. InternationalUnionof Hydroxyethylethylenediaminetriaceticacid,ferriccomplex PureandApplied Chemistry(IUPAC) 2. ChemicalAbstracts Service(CAS) CASnumber Molecularformula Molecularweight Structuralformula
3+ Fe

FeHEDTA Herbicide

Iron,[N(2[bis[(carboxy.kappa.O)methyl]amino.kappa.N]ethyl]N[2 (hydroxy.kappa.O)ethyl]glycinato(3).kappa.N,.kappa.O] 17084025 C10H15N2O7Fe 331.15

OH O N N O O O O

Purityoftheactive ingredient

4.51%asiron(presentasFeHEDTA)

1.2

PhysicalandChemicalPropertiesoftheActiveIngredientsandEndUseProduct

TechnicalProductNEU1173HTGAI
Property Colourandphysicalstate Odour Meltingrange Deepredliquid Odourless Notapplicable Result

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Boilingpointorrange Density Vapourpressureat20C Ultraviolet(UV)visiblespectrum

106C 1.396g/mL Notapplicable medium acidic neutral basic max (nm) 210 210 219 molarabs.(L/(mol*cm)) 3 6.6010 3 7.0610 3 4.2710

Solubilityinwaterat20C

Miscibleinallproportions Solubility completelyimmiscible completelyimmiscible FeHEDTAimmiscible aqueousportionmiscible completelysoluble

Solubilityinorganicsolventsat20C Solvent Hexanes Diethylether Acetone Methanol nOctanolwaterpartitioncoefficient logKow <0, (K ) ow Dissociationconstant(pK ) a Stability (temperature,metal)

pKa1 =2.4,pKa2 =5.4,pKa3 =9.9

Stableat54C,noncorrosivetoglass,plastic,stainlesssteel,brassand aluminum.Corrosivetogalvanizedsteel,zincandcopper.

EndUseProductNEU1173H,FiestaLawnWeedKiller,FiestaLawnWeedKillerReadyto Spray,NEU1173HLargeSize,NEU1173HReadytoSpray, NEU1173HReadytoSprayLargeSize

Property Colour Odour Physicalstate Formulationtype Guarantee Containermaterialanddescription Density pH Oxidizingorreducingaction DeepRed Odourless Liquid SNsolution 4.43%nominal HDPEbottles 1.401.42g/mL 5.930.12 Nosignificantreactionwithwater,a10%monoammoniumphosphate solution,ironpowderorkerosene.Reducingactivityseenwitha10% potassiumpermanganatesolution. AcceleratedstorageshowsarelativelossinassayofFeof<1%after2 weeksstorageat54Cand~4.3%lossafter2monthsstorageat40C. NoevidenceofcorrosiveeffectsonHDPEbottlesusedtostoretheproduct atambienttemperatureforoneyear. Nonexplosive
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Result

Storagestability Corrosioncharacteristics Explodability

EndUseProduct NEU1173HRTU,NEU1173HRTUWithPullNSprayApplicator, NEU1173HRTUwithQuickConnectSprayer

Property Colour Odour Physicalstate Formulationtype Guarantee Containermaterialanddescription Density pH Oxidizingorreducingaction Storagestability Corrosioncharacteristics Explodability DeepRed Odourless Liquid SNsolution 0.25%nominal HDPEbottles 1.011.02g/mL 5.810.04 Nosignificantoxidizingorreducingactivityobserved AcceleratedstorageshowsarelativelossinassayofFeof<1%after2 weeksstorageat54Cand~3.4%lossafter2monthsstorageat40C. NoevidenceofcorrosiveeffectsonHDPEbottlesusedtostoretheproduct atambienttemperatureforoneyear. Nonexplosive Result

1.3

DirectionsforUse

ThereareatotalofnineherbicideenduseproductsthatcontainFeHEDTAinConcentrate, ReadytoSprayandReadytoUseformats(Table1.3). Table1.3 HerbicidescontainingFeHEDTA

Guarantee 4.43%Fe

Productsbyformat(marketingclass) Concentrateproducts FiestaLawnWeedKiller(Commercial) NEU1173HLargeSize (Domestic) NEU1173H (Domestic) ReadytoSprayProducts FiestaLawnWeedKillerReadyToSpray(Commercial) NEU1173HReadyToSprayLargeSize (Domestic) NEU1173HReadyToSpray (Domestic) ReadytoUseproducts NEU1173HRTUwithPullNSprayApplicator(Domestic) NEU1173HRTUwithQuickConnectSprayer(Domestic) NEU1173HRTU (Domestic)

4.43%Fe

0.25%Fe

Eachoftheseproductsisaselectiveherbicideforthecontrolofseveralemergedbroadleaved weedspeciesinestablishedturf(residentialandcommerciallawns,noncropareas,including rightsofways,golfcourses,parks,cemeteries,andathleticfields).Eachoftheseproductsmay beappliedatuptotwotimesperseason,withnolessthan4weeksbetweenapplications,to controldandelion(Taraxacumofficinale),Englishdaisy(Bellisperennis),falsedandelion

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(Hypochaerisradicata),whiteclover(Trifoliumrepens),blackmedic(Medicagolupulina),bull thistle(Cirsiumvulgare),Canadathistle(Cirsiumarvense),commonchickweed(Stellaria media),creepingbuttercup(Ranunculusrepens),narrowleavedplantain(Plantagolanceolata), dovefootgeranium(Geraniummolle),slenderspeedwell(Veronicafiliformis),lawnburweed (Solivapterosperma),moss(variousspecies),andalgae(variousspecies),aswellastosuppress broadleavedplantain(Plantagomajor). 1.3.1 ConcentrateproductscontainingFeHEDTA Theseproductsrequiredilutionbeforeapplication:1partofconcentrateistobemixedwith24 2 partsofwaterfora4%solution.Themixedsolutionistobeappliedat200400ml/m witha 2 standardhandheldorbackpacksprayer.Thisequatesto0.51.0ga.i./m .Thelowerrateis intendedforcontrolofsmallerweedsandthehigherrateisintendedforcontroloflargerweeds andonsomeperennialweeds.Theseproductsareintendedforapplicationoveralargeareaorto largerpatchesofweeds. 1.3.2 ReadytoSprayproductscontainingFeHEDTA Theseproductsareautomaticallydilutedtothecorrectconcentrationwhenappliedviaahose 2 connectedtoawatersource.Thesprayistobeappliedat200400ml/m .Similartothe concentrateproducts,theseproductsareintendedforapplicationoveralargeweedinfestedarea ortolargerpatchesofweeds. 1.3.3 ReadytoUseproductscontainingFeHEDTA Theseproductsarereadytouseandrequirenofurtherdilution.Theyareintendedforapplication toindividualweedsorpatchesofweeds.Applicationismadeuntilweedfoliageisthoroughly wetted,justtothepointofrunoff. 1.4 ModeofAction

Theexactmodeofactionofironisunknownbutitmayinpartbebasedondifferentialuptakeand transportofiron,whenpresentinchelatedform.Syntheticchelatesofironareknowntobemore availablethannonchelatedironforuptakebybroadleavedplantswhichmayresultinexcessive ironuptake.Uptakeofsyntheticchelatesofironbygrassesmaybeinefficientrelativetothatin broadleavedspeciestherebyconferringagreaterleveloftolerance,althoughnotallgrassspecies areequallytolerantofsyntheticchelatesofiron.Ironisknowntofunctionasacatalystfor oxygenreduction,therebyproducingunstableandhighlyreactiveoxygenspecies,including hydroxylradicalsthatcausecellulardamage,leadingtocelldeath.Chelatedironhasnotbeen classifiedintoamodeofaction groupe.g.WSSAorHRAC.

2.0

MethodsofAnalysis
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2.1

MethodsforAnalysisoftheActiveIngredient

Themethodsprovidedfortheanalysisoftheactiveingredientandtheimpuritiesin FeHEDTA havebeenvalidatedandassessedtobeacceptableforthedeterminations. 2.2 MethodforFormulationAnalysis

Themethodprovidedfortheanalysisoftheactiveingredientintheformulationhasbeenvalidated andassessedtobeacceptableforuseasanenforcementanalyticalmethod. 2.3 MethodsforResidueAnalysis

Notrequired.

3.0
3.1

ImpactonHumanandAnimalHealth
ToxicologySummary

ThePMRAhasconductedadetailedreviewofthesubmitteddataandpubliclyavailable toxicologicalinformationforFeHEDTA.Thedatabaseisconsideredadequate,consistingofan arrayoflaboratoryanimal(invivo)andcellculture(invitro)toxicitystudiesand/orwaiver requestsforspecificelementsofinformationcurrentlyrequiredforhealthhazardassessment purposes.Thesubmittedtoxicologystudieswerecarriedoutinaccordancewithcurrently acceptedinternationaltestingprotocolsandGoodLaboratoryPractices.Thescientificqualityof thedataissuchthatthedatabaseisconsideredadequatetoqualitativelyassessthetoxicological hazardsofthispestcontrolproduct. Theapplicantsubmittedacutetoxicity,irritation,andsensitizationstudiesperformedwith NEU1173H,oneoftheproposedenduseproductswhichissimilartothetechnicalproduct,to supportregistrationofthetechnicalgradeactiveingredientandthenineassociatedenduse products.ThesubstancetestedinthesubmittedstudieswasFeHEDTA(26.52%w/w).Although thePMRArequirestoxicityandirritationstudiestobeconductedwitheachenduseproduct, giventhatnoneoftheformulationscontainformulantsoftoxicologicalconcern,testingwith NEU1173Hrepresentingalltheformulationswasconsideredacceptable. FeHEDTAwasoflowacutetoxicitybytheoral,dermal,andinhalationroutesinrats.Itwas minimallyirritatingtoeyesandnonirritatingtoskininrabbits.InaLocalLymphNodeAssay (LLNA)inmice,FeHEDTAwasadermalsensitizer.Thereisapparentpotentialforskin sensitizationassociatedwithrepeateddermalexposuretothetechnicalandenduseproducts. Theapplicantrequestedstudywaiversforshorttermdermal(90day,rodent),prenatal developmentaltoxicity(rodent),bacterialreversemutationassay,andgenotoxicity(invitro mammaliancellassay)onthefollowingbasis:
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1)ThelowtoxicityofFeHEDTAasobservedintheacutetoxicologystudies2)thelow dermalabsorptionofFeHEDTA3)theinformationinthepublishedliteratureonchemically similarEDTAcompounds(PMRAPRD200713)4)thelowapplicationrateofFeHEDTA (concentrateisdiluted1in25concentrationofironintheenduseproductsrangesfrom 0.254%)5)nonuseonfoodorfeedcrops6)ironsodiumEDTA(chemicallysimilar substance)isusedasasourceofdietaryironforfoodfortificationpurposesintheUnited StatesandsuchauseisapprovedbytheWorldHealthOrganization7)noreportof toxicologicalconcernsfromthehighvolumeuseofthischemicalworldwideasafertilizerfor counteractingirondeficiencyinplants8)trisodiumHEDTAwhichisthesourceofthe HEDTAintheactiveingredientisusedinsoapsandcosmetics. Furthermore,theapplicantprovidedasummaryofthetoxicityprofileforferricsodiumEDTA, evaluatedandregisteredbythePMRAasamolluscicide,fromthePMRAdocumentPRD2007 13tosupportthewaiverrequests(Table2,AppendixI). PublishedinformationdemonstratingthechronictoxicitypotentialofFeHEDTAwasnotavailable forevaluationtherefore,informationavailablefromtheevaluationonferricsodiumEDTAwas used.HEDTAoftheproposedcompounddiffersfromEDTAoftheregisteredferricsodium EDTAinthatoneofthecarboxylgroups(COOH)oftheEDTAhasbeenreplacedwitha hydroxyl(CH2OH)group(Figure1,AppendixI).Duetotheclosechemicalsimilarity,biological effectsoftheseironchelatesarenotexpectedtobedifferent,andthetoxicityofHEDTAandits saltsandEDTAanditssaltsisexpectedtobesimilarandlow. Inthegastrointestinaltract(GItract),ferricsodiumEDTA,likeotherEDTAcomplexes, dissociatestoformironandanEDTAsaltwhichareabsorbedindependently.Compoundsof EDTAarepoorlyabsorbedintheGItract,donotundergosignificantmetabolicconversion,and havealowdegreeofacuteoraltoxicity.MetalionsontheEDTAmetalcomplexarefreely exchangedintheGItracttherefore,thetoxicologicaleffectsofEDTAsaltsarelikelytobe similarirrespectiveofthesaltform.Inchronictoxicitystudies,dietscontainingasmuchas5% EDTAwerewithoutadverseeffects.EDTAcompoundswerenotcarcinogenicinanimal bioassaysandarenotdirectlygenotoxic. Inhumans,ironabsorptionfromferricsodiumEDTAisrelatedtobodyironreserves.Generally, 3+ ferric(Fe )ironinfoodandsupplementsispoorlyabsorbedbecauseitisprecipitatedfrom solutionatapHabove3.5,andinsolubleprecipitateispoorlyabsorbedintheuppersmall intestinebyhumans,wheremostnonhemeironisabsorbed,unlesssuitablecomplexingagentsare present.Publiclyavailableinformationsuggeststhatnormalindividualsarecapableofcontrolling ironabsorptionandthatchronictoxicity(namely,hemochromatosis)isgenerallylimitedto individualswithinheritedmetabolicdisordersaffectingmaintenanceofironbalanceinthebody.In 55 14 swine,exposuretoradiolabelledferricsodiumEDTA(Na Fe[2 C]EDTA,5mgintroduced intotheesophagus)resultedin95%recoveryinthefecesand0.3%intheurine.Absorptionofa single,nonlethal,oraldoseofferricsodiumEDTAintroducedintotheesophaguswasanticipated tobepoor,withnearlycompleteexcretioninthefeces.MetabolismofferricsodiumEDTAis anticipatedtobenegligiblebasedonareviewofpublishedscientificinformation.
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TherequirementforshorttermdermaltoxicitytestingwaswaivedbecauselikeotherEDTA compoundsironHEDTAisnotlikelytobereadilyabsorbedthroughtheskinandhaslowacute dermaltoxicity.Aclinicalstudyinhumanmalesreportedalmostnoabsorptionofcalcium disodiumEDTAfollowingdermalexposure. Therequirementforaprenataldevelopmentaltoxicitystudywasalsowaivedbasedonthe summaryofreproductionanddevelopmentaltoxicitystudiesforferricsodiumEDTA. AdministrationofalargequantityofdisodiumEDTA(954mg/kgbw/day)inthedietof pregnantCDrats(day7through14ofgestation)resultedinmaternaleffectsmarkedbyweight loss,decreasedfoodconsumptionanddiarrheainalltestanimalsandgrossfetalmalformations. WhendisodiumEDTA(3%byweight)wasaddedtothedietofpregnantSpragueDawleyrats fromdays6to14ofgestationorfromday6toterm,themajorityoffetusesweregrossly malformed.Whenthedietofexposedratswassupplementedwithzinc(1000ppm),nofetal malformationswerenoted,suggestingthatthemalformationswerenotdirectlycausedbyEDTA butweretheresultofsecondaryeffectsduetosequesteringofzincrequiredfornormalfetal development.ItseemsthatbybindingtodivalentandtrivalentcationsEDTAinlargeamounts cancausemineraldeficienciesthereby,resultingintoxicologicaleffects. Therequirementforagenotoxicity/mutagenicitystudywaswaivedbasedontheavailable informationfromtheevaluationofferricsodiumEDTA.Therewasnoevidenceof genotoxicity/mutagenicitywhentrisodiumEDTAwastestedin Salmonellatyphimuriumstrains (TA98,TA100,TA1535,TA1537,andTA1538),Escherichiacoli(WP2uvrA)andinmouse lymphomacellswithandwithoutmetabolicactivation.ThissuggeststhattheEDTAmoietyisnot mutagenic/genotoxic.TherewasevidenceofgenotoxicpotentialofferricsodiumEDTAinmouse lymphomacellsinthepresenceandabsenceofmetabolicactivation.Itshouldbenoted,however, thatitisanticipatedthattheFeandEDTAwilldissociateinsolutionandthatFeuptakebya 3+ 2+ transferrinindependenttransportsystemrequiresreductionofFe toFe atthecellsurface.The 2+ 3+ ferrousionisthensubjecttoFentonreaction:Fe +H2O2 Fe +.OH+OH.Thehydroxyl freeradicalisexpectedtoattacktheDNA,resultingintheobservedgenotoxicity.Thegenotoxic reactionisthereforelikelytobeanindirectresultofironandnotoftheferricsodiumEDTA.The genotoxicnatureofironisnotaconcernbecauseitisanessentialelementrequiredbythehuman bodyandisreadilyavailablefromfood.Theadverseeffectsofexcessdietaryironinnormal individualshavenotbeenreported.Foriron,theRecommendedDietaryAllowance(RDA)is8 mg/dayforallagegroupsofmenandpostmenopausalwomenand18mg/dayforpremenopausal women.Thetolerableupperintakelevel(UL)foradultsis45mg/dayiron,basedon gastrointestinaldistressasanadverseeffect. ResultsoftheacutetestswithFeHEDTAandchronictestsforferricsodiumEDTA conductedon laboratoryanimals,alongwiththetoxicologyendpointsforuseinthehumanhealthrisk assessment,aresummarizedinTables1and2ofAppendixI. 3.2 DeterminationofAcceptableDailyIntake(ADI)
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Astheenduseproductsarenotintendedfordirectapplicationtofoodcrops,determinationofan acceptabledailyintakeisnotrequired. 3.3 DeterminationofAcuteReferenceDose(ARfD)

Astheenduseproductsarenotintendedfordirectapplicationtofoodcrops,determinationofan acutereferencedoseisnotrequired. 3.4 OccupationalandResidentialRiskAssessment

3.4.1 UseDescription/exposureScenario Productuse

2 Theenduseproductsaretobeappliedontoindividualweedsatarateof200400mL/m (2000 to4000L/ha).Forbestresults,thelabelsinstructtoreapply withnolessthan4weeksbetween applicationsuptoamaximumof2applicationsperyearpertreatmentsite.

ReadyToUseEnduseproducts:NEU1173HRTUWithPullnSprayApplicator,NEU1173H RTUWithQuickConnectSprayer,NEU1173HRTU(Ironpresentas FeHEDTA 0.25%) Applicationoftheseproductsdoesnotinvolvemixingorloadingastheyarereadytouse formulationsappliedwiththeintegratedapplicatorontheproductcontainer.Thenozzleistobe adjustedtoachieveadesiredspraypattern.Fortheseproducts,onaverage,aresidentialuser wouldbetreatingalawnareaof0.0093hapertreatmentperdaywith18.637.2Loftheenduse products,andtheestimatedamountofactiveingredientusedwouldbe0.047to0.094kgofiron presentasFeHEDTA. ReadyToSpray:NEU1173HReadytoSprayLargeSize,NEU1173HReadytoSpray(Iron presentasFeHEDTA4.43%) Applicationoftheseproductsdoesnotinvolvemixingorloadingastheyarereadytouse formulationsandwillbeappliedusingahoseendsprayerattachedtotheproductcontainer.A gardenhoseistobeattachedtothehoseendsprayerasperthelabelinstructionsandthesprayer istobecalibratedtoachieveadilutionratioof1:24inwater.Fortheseproducts,onaverage,a residentialuserwouldbetreatingalawnareaof0.10hapertreatmentperdaywith816Lofthe enduseproducts,andtheestimatedamountofactiveingredientusedwouldbe0.51to1.02kg ironpresentasFeHEDTA. HandheldorBackpackapplication:NEU1173HLargeSize,NEU1173H(Ironpresentas FeHEDTA4.43%)
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Theproposedapplicationisbyanystandardhandheldorbackpacksprayer.Theproductistobe loadedandmixedwithwaterat1:24ratioandsprayedtoachieveauniformcoverageofthearea tobetreated.Toreducespraydrift,thelabelsinstructuserstosetsprayerstoacoarsenozzle setting.Forapplication,aresidentialuserwouldbetreatinganaveragelawnareaof0.0093haper treatmentperdaywith0.741.48Loftheenduseproducts,andtheestimatedamountofactive ingredientusedwouldbe0.047to0.094kgironpresentasFeHEDTA. FiestaLawnWeedKillerReadytoSpray(IronpresentasFeHEDTA4.43%) Thereisnomixingorloadinginvolvedastheproductisareadytouseformulationtobeapplied usingahoseendsprayerattachedtotheproductcontainer.Agardenhosewouldbeattachedto thehoseendsprayerasperthelabelinstructions,andthesprayeristobecalibratedtoachievea dilutionratioof1:24inwater.Atamaximumapplicationrate,20.2hacanbetreatedinaday with16163232Loftheenduseproduct,andtheestimatedamountofactiveingredienthandled byacommercialapplicatorinadaywouldbe101kgto202kgironpresentasFeHEDTA. FiestaLawnWeedKiller(IronpresentasFeHEDTA4.43%) Theproductistobetransferredtoanystandardhandheldorbackpacksprayerandwouldbe dilutedwithwaterat1:24ratio.Toreducespraydrift,thelabelinstructsuserstosetsprayerstoa coarsenozzlesetting.Atamaximumapplicationrate,2.02hacanbetreatedinadaywith161.6 323.2Loftheenduseproduct,andtheestimatedamountofactiveingredienthandledinadayby acommercialapplicatorwouldbe10.1kgto20.2kgironpresentasFeHEDTA. 3.4.2 ToxicologicalEndpoints Occupationalandresidentialexposurestoenduseproductsareexpectedtobeshorttermin durationandpredominantlybythedermalrouteduringhandlingandapplicationandfromdermal contactofwettreatedsurfaces.Inhalationofspraymistisalsopossible,butislikelytobeaminor routeofexposure.Theenduseproductsareanticipatedtobeoflowacutetoxicitybytheoral, dermal,andinhalationroutes.Theyarelikelytobenonirritatingtotheskin,butminimally irritatingtoeyes,andarelikelytobeskinsensitizers.Repeateddermalexposuretoenduse productscanresultinskinsensitization.Theproperuseandhandlingoftheproposedenduse products,followinglabeldirections,isnotlikelytoresultinrepeatedorprolongedhuman exposurebyanyroutesataconcentrationthatislikelytoraisetoxicologicalconcerns.The publiclyavailableinformationontheactiveingredientsuggeststhattheproposeduseofenduse productsisunlikelytohaveanyshorttermorprenataldevelopmentaleffectsorgenotoxiceffects. 3.4.3 DermalAbsorption AstheavailablepublishedliteraturesuggestsnegligibledermalabsorptionforEDTAcompounds, andsincetheproductlabelshaveadequateprecautionaryandhygienestatementstoprevent repeatedandprolongeddermalexposure,adermalabsorptionstudywasnotconsiderednecessary tocompletethehealthhazardassessmentofFeHEDTA.
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3.4.4 Mixer,LoaderandApplicatorExposureandRiskAssessment Theproposeduseofthecommercialproductsmay resultinexposuretothemixer,loader,and applicator,aswellasthoseresponsibleforcleanupandmaintenanceactivities,butsignificant risksfromsuchexposuresarenotanticipatedduetothelowtoxicityoftheenduseproductsand adequateexposuremitigationmeasuresrecommendedonthelabels.Loadingandmixingis requiredonlyforoneofthetwocommercialproducts.Applicatorsmaybeexposedthrough inhalationofspraydriftandalsodermallythroughcontactwithwetsprayedsurfaces.Theenduse productshavelowtoxicitybytheinhalationroute,butmayactasrespiratoryirritants.Theend useproductsarepoorlyabsorbedthroughskintheyarenottoxicorirritatingtoskin,butare potentialskinsensitizers.Dermalexposurecanbemitigatedbyrestrictingentryorreentrytothe freshlytreatedsitesuntiltheappliedsprayisdried.Ocularexposuretotheenduseproductsis likelytocauseminimaleyeirritation. 3.4.5 ResidentialRiskAssessment Theproposeduseofthedomesticproductsandalsocommercialproductsmayresultinexposure tousersandbystanders,butsignificantrisksfromsuchexposuresarenotanticipatedduetothe lowtoxicityoftheenduseproductsandadequateexposuremitigationmeasuresrecommendedon thelabels.Loadingandmixingisrequiredonlyforproductsusingstandardhandheldorbackpack sprayerapplicationthatis,twodomesticenduseproducts.Applicatorsmaybeexposedthrough inhalationofspraydriftandalsodermallythroughcontactwithwetsprayedsurfaces.Theenduse productshavelowtoxicitybytheinhalationroute,butmayactasrespiratoryirritants.Prolonged dermalexposureisnotlikelyandenduseproductsarepoorlyabsorbedthroughskin.Exposureto childrenfromdirectdermal orhandtomouthcontactispossibleiftheyweretoplayonlawns freshlytreatedwithFeHEDTA.Restrictingentryorreentrytothefreshlytreatedsitesuntilthe sprayhasdriedcanmitigatethisexposure. Exposurereductionstatementsincludingtherequirementforpersonalprotectiveequipmentand mitigativeandhygienestatementsonthelabelsareadequatetoprotectdomesticusersand bystandersagainstanyunnecessaryriskfromresidentialexposureiflabeldirectionsarefollowed. 3.5 FoodResiduesExposureAssessment

FeHEDTAproductsarenotapplieddirectlytofood.Theriskfromdietaryexposureisconsidered negligible,soafoodresidueexposureassessmentwasnotrequired.

4.0
4.1

ImpactontheEnvironment
FateandBehaviourintheEnvironment

FeHEDTAischemically similartootherironsaltsofEDTAsuchasFerricsodiumEDTAand FerricEDTA,basedontheirphysicalpropertiesrelevanttoenvironmentalchemistryandfate.In

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theterrestrialenvironment,FeHEDTAisnotexpectedtovolatilizeunderfieldconditions(i.e fromdry,wetormoistsurfaces).FeHEDTAisexpectedtobelessstableinalkalineand calcareoussoils(pH78)whereironion isdisplacedby calcium ion andprecipitatesasFe(OH)3. FeHEDTAisexpectedtoberapidlytransformedbynaturallightinwater.Basedontheproposed usepattern(modeofapplication,applicationrateanduseareas),theriskforpotentialleaching andexposureof FeHEDTAtodrinkingwater(surfaceorgroundwater)willbelow. Dataonthefateandbehaviourof FeHEDTAaresummarizedinTable3ofAppendixI. 4.2 EnvironmentalRiskCharacterization

Theenvironmentalriskassessmentintegratestheenvironmentalexposureandecotoxicology informationtoestimatethepotentialforadverseeffectsonnontargetspecies.Thisintegrationis achievedbycomparingexposureconcentrationswithconcentrationsatwhichadverseeffects occur.Estimatedenvironmentalexposureconcentrations(EECs)areconcentrationsofpesticide invariousenvironmentalmedia,suchasfood,water,soilandair.TheEECsareestimatedusing standardmodelswhichtakeintoconsiderationtheapplicationrate(s),chemicalpropertiesand environmentalfateproperties,includingthedissipationofthepesticidebetweenapplications. Ecotoxicologyinformationincludesacuteandchronictoxicitydataforvariousorganismsor groupsoforganismsfrombothterrestrialandaquatichabitatsincludinginvertebrates,vertebrates, andplants.Toxicityendpointsusedinriskassessmentsmaybeadjustedtoaccountforpotential differencesinspeciessensitivityaswellasvaryingprotectiongoals(i.e.protectionatthe community,population,orindividuallevel). Initially,ascreeninglevelriskassessmentisperformedtoidentifypesticidesand/orspecificuses thatdonotposearisktonontargetorganisms,andtoidentifythosegroupsoforganismsfor whichtheremaybeapotentialrisk.Thescreeninglevelriskassessmentusessimplemethods, conservativeexposurescenarios(e.g.directapplicationatamaximumcumulativeapplication rate)andsensitivetoxicityendpoints.Ariskquotient(RQ)iscalculatedbydividingtheexposure estimatebyanappropriatetoxicityvalue(RQ=exposure/toxicity),andtheriskquotientisthen comparedtothelevelofconcern(LOC=1).Ifthescreeninglevelriskquotientisbelowthelevel ofconcern,theriskisconsiderednegligibleandnofurtherriskcharacterizationisnecessary.Ifthe screeninglevelriskquotientisequaltoorgreaterthanthelevelofconcern,thenarefinedrisk assessmentisperformedtofurthercharacterizetherisk.Arefinedassessmenttakesinto considerationmorerealisticexposurescenarios(suchasdrifttonontargethabitats)andmight considerdifferenttoxicityendpoints.Refinementsmayincludefurthercharacterizationofrisk basedonexposuremodelling,monitoringdata,resultsfromfieldormesocosmstudies,and probabilisticriskassessmentmethods.Refinementstotheriskassessmentmaycontinueuntilthe riskisadequatelycharacterizedornofurtherrefinementsarepossible. 4.2.1 RiskstoTerrestrialOrganisms Risktoterrestrialorganismswasbasedupontheevaluationof FeHEDTA toxicitydataforthe following(AppendixI,Table4):
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 onespeciesofhoney bee(oral andcontactexposure)representinginvertebrates and twobirdandonemammalspeciesrepresentingvertebrates(acuteanddietary). Theuncertaintyfactorsusedin adjustingthetoxicityvaluesaresummarizedin AppendixI,Table 5. Foran assessmentofbees,ascreeninglevelEECforacuteoralorcontactexposuretoresiduesis 62.4kgFeHEDTA/ha.Forbees,theLD50 valuesing/beewereconvertedtotheequivalentrates inkg/habymultiplyingwith 1.12.TheconvertedLD50 valuewas93.7kgFeHEDTA/ha.The screeninglevelRQvaluewas<0.66therefore,negligiblerisktohoneybeesisexpected. Fortheassessmentofbirdsandsmallwildmammals,theEECvaluesforFeHEDTA inpotential fooditemsweredeterminedforadirectapplication immediatelyafteraspray of 59kg FeHEDTA/ha.Thescreeninglevelestimateddailyexposure(EDE)valuesweredependentonthe bodyweightofanorganism(20,100,1000gforbirdsand15,35,1000gformammals),food preferences(100%smallinsectsforinsectivores,100%fruitsforfrugivores,100%grainand seedsforgranivores,and100%leavesandleafycropsforherbivores),andamountconsumedon adailybasis.TheFeHEDTA toxicityendpointsusedwereLD50 >530.4mg/kgbwforacute exposureand>307.13mg/kgbw/day fordietary assessmentofbirds,andLD50 >1326mg/kgbw foracuteassessmentof smallmammals.MostofthescreeninglevelandrefinedRQvalueswere higherthan1forbirdsandsmallwildmammalsduetothehigh applicationrateforturf (Appendix I,Table6&Table8).However,basedonthelimitedexposureexpectedfromuseonturf,which involveslocalizedfoliartreatmentusingstandardhandheldorbackpacksprayers,andcoarse dropletssprays,therisktobirdsandmammalsisexpectedtobeminimal. FeHEDTA,atappropriaterates,isusedasabroadleafherbicide.Thus,precautionarylabel statementsarerequiredtopreventdamagetodesirableplants. 4.2.2 RiskstoAquaticOrganisms Risksof FeHEDTA toaquaticorganismswerebasedupontheevaluationof FeHEDTA datafor thefollowing(AppendixI,Table4): onefreshwaterinvertebratedaphnidspecies(acuteexposure) and onefreshwaterfishspecies(acuteexposure). TheuncertaintyfactorsusedinmodifyingthetoxicityvaluesaresummarizedinAppendixI,Table 5.Wherenodoserelatedeffectswereobserved,theuncertaintyfactorswerenotused. ScreeninglevelEECvaluesforFeHEDTA inwaterwerecalculatedassumingareasonable conservativescenarioofdirectapplicationtowaterbodiesoftwodifferentdepths(80cmand15 cm).The80cmwaterbodyischosentorepresentapermanentbodyofwaterand15cmis chosentorepresentaseasonalbodyofwater.Thepesticideisassumedtobeinstantaneouslyand
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completelymixedwithinthewaterbody. Forassessmentoffishandaquaticinvertebrates,ascreeninglevelEECof FeHEDTA in permanentwaterbody(80cmwaterdepth)is7.8mg/L basedonanapplicationrateof 59kg FeHEDTA/ha,twotimesperyear.AllscreeninglevelRQvalueswere<1(AppendixI,Table8c). Therefore,therearenegligibleriskstofishandaquaticinvertebrates,onanacutebasis. Forassessmentofamphibians,ascreeninglevelEECof FeHEDTA inaseasonalwaterbody(15 cmwaterdepth)is41.6mg/Lbasedonanapplicationrateof 59kgFeHEDTA/ha,twotimesper year.Basedonfishtoxicitydata,RQvalueswere<1.5foracuteexposure(AppendixI,Table7) indicatingthatthelevelofconcernmaybeexceededforamphibians. AvailableinformationontheeffectsofironinferricsodiumEDTAonnontargetorganisms indicatesthattheironinthesechelatesinteractswiththehemocyanininthebloodstreamof molluscsandcrustaceans,andwouldbetoxictotheseorganisms.However,exposureto freshwatermolluscsandcrustaceansaswellasamphibiansisunlikelytooccurgiventheintended useof FeHEDTAasabroadleafherbicideapplieddirectlytotargetedterrestrialplants.

5.0
5.1

Value
EffectivenessAgainstPests

5.1.1 AcceptableEfficacyClaims Efficacydataweresubmittedfrom35trialsconductedin2005,2006and2007.Nineteenofthese trialswereconductedinthefieldinSaanichton,BritishColumbia(17trials),Ridgetown,Ontario, andFresno,California.Theremaining16trialswereconductedinthegreenhouseinSaanichton, 2 B.C.Theapplicationratestestedvariedbytrialandincludedratesfrom0.4to1.6ga.i./m .A secondapplicationwasmade24weeksafterthefirstin17ofthe35trials.Allgreenhousetrials werereplicated4to10timeswitheachtreatmentreplicatecombinationconsistingofoneplantin onepot.Treatmentswerereplicatedtwoorfourtimesinfieldtrialsexceptfortwotrialsthatwere unreplicated. Ingreenhousetrials,applicationsweremadetosingleplantsinsinglepotsbyahandtrigger sprayerorahandpumpsprayer.Infieldtrials,applicationwasmadebyahandpumpsprayer, pressurizedpumpsprayer,hosesprayer,orhandtriggersprayer.Efficacywasvisuallyassessed from1to42daysafterapplication,or528daysafterasecondapplication,andwasreportedas percentphytotoxicity,percentinjury,percentstandreduction,orpercentcontrol.Thenumberand timingofevaluationswasspecifictotrial. ThesubmittedefficacydataconditionallysupporttheefficacyclaimssummarizedinTable5.1.1 2 fortheNEU1173Hproductsappliedat0.51.0ga.i./m .Theminimumrateisintendedfor applicationtosmallerweedswhilethemaximumrateisintendedforapplicationtolargerweeds
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ormoredifficulttocontrolperennialweeds.Datawereadequatetosupportamaximumoftwo applicationsperseasonwithnolessthan4weeksbetweenapplications.Datawereadequateto supportarainfastintervalof3hours. Table5.1.1.Weedspeciesforwhichefficacyclaimsareconditionallysupportedforthe 2 NEU1173Hproductsappliedat0.51.0ga.i./m .

Pestspeciesorgroup Claimofcontrol Dandelion Taraxacum officinale Bellisperennis Hypochaeris radicata Trifoliumrepens Medicagolupulina Cirsiumvulgare Cirsiumarvense Stellariamedia Ranunculusrepens Veronicafiliformis Plantagolanceolata commondandelion P Scientificname Othercommonnames Lifecycle

Englishdaisy Falsedandelion

Europeandaisy spottedcatsear,commoncatsear,hairycats ear,coastdandelion Dutchclover,creepingwhiteclover hopclover commonthistle, creepingthistle,fieldthistle chickweed,commonstarwort buttercup,creepingcrowfoot creepingspeedwell Englishplantain,buckhorn,buckhornplantain, blackplantain,lanceleavedplantain,ribgrass dovesfootgeranium,dovesfoot,cranesbill, woodlandgeranium spurweed

P P

Whiteclover Blackmedic Bullthistle Canadathistle Commonchickweed Creepingbuttercup Slenderspeedwell Narrowleavedplantain

P AorB WA,B,orMP P A,WAorSLP P P P

Dovefootgeranium

Geraniummolle

A,B,orP

Lawnburweed

Solivapterosperma orS.sessilis variousspecies variousspecies

WA

Moss Algae Claimofsuppression Broadleafplantain

Plantagomajor

commonplantain,plantain

A:annualWA:winterannualB:biennialP:perennialMP:monocarpicperennialSLP:shortlivedperennial.

5.2

PhytotoxicitytoHostPlants

5.2.1 AcceptableHostToleranceClaimsfortheNEU1173HProducts Dataweresubmittedfrom11trialsinwhichthetoleranceofturfgrassestooneortwo

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applicationsof theNEU1173Hproductswasevaluated.Thetoleranceofperennialryegrasswas evaluatedinsevengreenhousetrialsconductedin2006and2007inSaanichton,BritishColumbia. ThetoleranceofestablishedturftotheNEU1173Hproductswasevaluatedinthreefieldtrials conductedin2005and2006atSaanichton,B.C.,twoofwhichweresituatedonParkturf consistingofabout65%perennialryegrassand25%ofamixtureofchewingsfescueandcreeping fescuetheturfspeciescompositioninthethirdtrialwasunknown.Thetoleranceofestablished turfconsistingofmainlyKentuckybluegrasswithsomechewingsfescueandperennialryegrass wasevaluatedinonefieldtrialconductedin2005atRidgetown,Ontario.Therewerenostudies inwhichthetoleranceoffescuegrassestotheNEU1173Hproductswasspecificallyassessed.
2 Theapplicationratestestedvariedbytrialandrangedfrom0.51.0ga.i./m inthegreenhouse 2 trialsandfrom0.561.66ga.i./m inthefieldtrials.Asecondapplicationwasmade24weeks afterthefirstinthreegreenhousetrialsandtwoweeksafterthefirstintheonefieldtrialthatwas conductedonturfofunknownspeciescomposition.

Ingreenhousetrials,thereweretenpots(replicates)pertreatmentofperennialryegrassseedlings from3.59weeksold.Applicationsweremadebyahandtriggersprayer. Infieldtrials,applicationwasmadebyahandpumpsprayer(2trials),handtriggersprayer(1 trial),orahosesprayer(1trial).Treatmentswerereplicatedtwiceinthethreefieldtrials conductedatSaanichtonandfourtimesinthetrialatRidgetown. Phytotoxicitywasvisuallyassessedfrom143daysafterapplication,or521daysaftera secondapplication(made1429daysafterthefirst),andwasreportedaspercentphytotoxicity orpercentinjury.Thenumberandtimingofevaluationswasspecifictotrial. Overallinjurytoturfwaslowandconsistedmainlyofleafdarkeningandsomenecrosis.These effectshadusuallydiminishedby4weeksafterapplicationinfieldtrials.Ingreenhousetrials,the lowinjuryinitiallyobservedtoperennialryegrassseedlingsdidnotdecreasebythelastevaluation 2 conducted24weeksafterafirstapplicationof0.41.0ga.i./m .Intwoofthethreegreenhouse 2 trials,injurytoperennialryegrassoneweekfollowingasecondapplicationof0.8or1.0ga.i./m wasgreaterthanthatobservedoneweekfollowingthefirstapplication.Intheonefieldtrialin 2 whichtwoapplicationsof0.8ga.i./m wasmade,injurywasgreaterfollowingthesecond application. Thesubmittedtolerancedataconditionallysupportaclaimoftoleranceforestablishedturf comprisedofoneormoreofKentuckybluegrass,perennialryegrass,andfescuetreatedwith0.5 2 1.0ga.i./m .Thesubmittedtolerancedataareadequatetosupportamaximumoftwo applicationsperseasonwithnolessthan4weeksbetweenapplications. 5.3 ImpactonSucceedingCrops

NotapplicableastheNEU1173Hproductsareforapplicationtoestablishedturf.
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5.4

Economics

NomarketanalysiswasconductedorreviewedfortheNEU1173Hproducts. 5.5 Sustainability

5.5.1 SurveyofAlternatives Wheremanualremovalofweedyplantsinturfisnotconsideredtobepractical,herbicidesmaybe used.Themostcommonconventionalherbicidesusedforbroadleavedweedcontrolonturfare thosethatbelongtothesyntheticauxingroupandinclude2,4D,mecoprop,mecoproppand dicamba.Inmanyherbicideonlyproductsaswellasinfertilizerherbicidecombinationproducts, 2,4Disincludedalone,incombinationwithmecoprop,orincombinationwithbothmecoprop anddicamba.Thespectrumof weedscontrolledvariesbytheherbicideorcombinationof herbicidesincludedintheproduct.Productsthatcontainthreewaymixturesof2,4D,mecoprop, anddicamba,generallyincludecontrolclaimsforthegreatestnumberofweedspecies.Other herbicides,includingclopyralid,picloram,triclopyr,anddichlorpropareregisteredforuseonnon cropareas,includingroadsides,butarenotforuseonfineturf. Interestinalternativeturfherbicidesisincreasing.Cornglutenisaregisterednatural alternative tosyntheticherbicidesfordomesticandcommercialuse.Cornglutenmayinhibittheseed germinationofcrabgrassanddandelionwhenusedinconjunctionwithasoundlawnmaintenance program.Aceticacid(e.g.EcoClear)isregisteredfordomesticandcommercialuseforcontrolof broadleavedweedsinandaroundthegarden,includingasaspotapplicationinturf.Potassium saltsoffattyacids(e.g.SafersDeMossMossKillerHerbicide)areregisteredfordomesticand commercialuseforthecontrolofmossinturf.Ferroussulfate(e.g.GreenleafMossControl)is registeredformosscontrolinturf.Noproductisregisteredforthecontrolofalgaeinturf. 5.5.2 CompatibilitywithCurrentManagementPracticesIncludingIntegratedPest Management Culturalmeasurescanbetakentodiscourageweedinfestations,includingproperfertilizationand wateringregimesthatencouragedevelopmentofdenseturftherebyinhibitingestablishmentof weeds,mowingatthecorrectheight(nolessthan5cm)andfrequency(removingnomorethan onethirdofbiomass),andaeratinganddethatchingwhennecessary.Useof theNEU1173H productsiscompatiblewithsuchpractices,particularlyinthatitisappliedonlywhenweedshave emergedandisnotusedasapreventativetreatment.Patchesofbroadleavedweedsmaybe treatedwithspotapplicationsof theNEU1173Hproducts.Smallpatchesorindividualweedsmay betreatedwith theNEU1173HproductsintheReadytoUseformat. 5.5.3 InformationontheOccurrenceorPossibleOccurrenceoftheDevelopmentof Resistance Theexcessivelevelofironthatoccursinsusceptibleplantstreatedwith theNEU1173Hproducts
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isbelievedtobetheresultofuncontrolleduptakeofironthatischelatedwithHEDTA. Developmentofresistancetouptakeofthissyntheticironchelateisnotexpected. 5.5.4 ContributiontoRiskReductionandSustainability Theavailabilityof theNEU1173Hproductsprovidesanalternativeherbicideoptionandmodeof actiontocommonlyusedherbicidesforbroadleavedweedcontrolinturf.

6.0
6.1

PestControlProductPolicyConsiderations
ToxicSubstancesManagementPolicyConsiderations

TheToxicSubstancesManagementPolicy(TSMP)isafederalgovernmentpolicydevelopedto providedirectiononthemanagementofsubstancesofconcernthatarereleasedintothe environment.TheTSMPcallsforthevirtualeliminationofTrack1substances[thosethatmeetall fourcriteriaoutlinedinthepolicy,i.e.,persistent(inair,soil,waterand/orsediment),bio accumulative,primarilyaresultofhumanactivityandtoxicasdefinedbytheCanadian EnvironmentalProtectionAct]. Duringthereviewprocess,FeHEDTA anditstransformationproductswereassessedin 1 accordancewith thePMRARegulatoryDirectiveDIR9903 andevaluatedagainsttheTrack1 criteria.ThePMRAhasreachedthefollowingconclusions: FeHEDTA doesnotmeetTrack1criteria,andisthereforenotconsideredaTrack1 substance.SeeAppendix1,Table10forcomparisonwithTrack1criteria. Transformationof FeHEDTA doesnotresultin anytransformationproductsthatmeet Track1criteria. 6.2 FormulantsandContaminantsofHealthorEnvironmentalConcern

Duringthereviewprocess,contaminantsinthetechnicalandformulantsandcontaminantsinthe enduseproductsarecomparedagainsttheListofPestcontrolProductFormulantsand 2 ContaminantsofHealthorEnvironmentalConcernmaintainedintheCanadaGazette . Thelist 3 isusedasdescribedinthePMRANoticeofIntentNOI200501 andisbasedonexistingpolicies

1

DIR9903,ThePestManagementRegulatoryAgencysStrategyforImplementingtheToxicSubstances ManagementPolicy 2 CanadaGazette,PartII,Volume139,Number24,SI/2005114(20051130)pages26412643:ListofPest ControlProductFormulantsandContaminantsofHealthorEnvironmentalConcernandintheorderamending thislistinthe CanadaGazette,PartII,Volume142,Number13,SI/200867(20080625)pages16111613.Part 1FormulantsofHealthorEnvironmentalConcern,Part2FormulantsofHealthorEnvironmentalConcernthat areAllergensKnowntoCauseAnaphylacticTypeReactionsandPart3ContaminantsofHealthorEnvironmental Concern. 3 NOI200501,ListofPestControlProductFormulantsandContaminantsofHealthorEnvironmentalConcern undertheNewPestControlProductsAct.
Page24

4 andregulationsincluding:DIR9903andDIR200602 ,andtakingintoconsiderationtheOzone depletingSubstanceRegulations,1998,oftheCanadianEnvironmentalProtectionAct (substancesdesignatedundertheMontrealProtocol).ThePMRAhasreachedthefollowing conclusions:

TechnicalgradeFeHEDTA andtheNEU1173Henduseproductsdonotcontainany formulantsorcontaminantsofhealthorenvironmentalconcernidentifiedinthe CanadaGazette. Theuseofformulantsinregisteredpestcontrolproductsisassessedonanongoingbasisthrough 5 PMRAformulantinitiativesandRegulatoryDirectiveDIR200602 .

7.0
7.1

Summary
HumanHealthandSafety

TheavailableinformationforFeHEDTAisadequatetoqualitativelydefinethemajorityoftoxic effectsthatmayresultfromhumanexposuretoFeHEDTA.Overall,FeHEDTAisoflowacute toxicityirrespectiveoftheexposureroutes.Itisnotirritatingtoskin,butminimallyirritatingto eyes,andisapotentialskinsensitizer.Repeateddermalexposuretotechnicalproductand associatedformulationscanresultinskinsensitization. Commercialapplicators,loaders,mixers,andthoseinvolvedincleanupandmaintenance activities,domesticusers,and/orbystandersarenotlikelytobeexposedtolevelsofFeHEDTA thatwillresultinunacceptableriskwhentheproductformulationsareusedaccordingtolabel directions.ChildrencouldbeexposedtoFeHEDTAbydirectdermalorhandtomouthcontactif theyweretoplayonfreshlytreatedlawnsurfaces.Tominimizethispotentialforexposure,a restrictedentrystatementwillbeaddedtotheproductlabelsprohibitingentryorreentryto treatedareasuntilthesprayhasdried.Exposuremitigationmeasuresareadequatetoprotect humanhealthfromresidentialandoccupationalexposure.Amaximumresiduelimitwasnot promulgatedbecausetheproposeduseisnonfoodtherefore,exposurefromfoodisunlikely. 7.2 EnvironmentalRisk

Limitedenvironmentalriskswereidentifiedasaresultoftheassessmentof theproposeduseof FeHEDTA.Useof FeHEDTAandtheNEU1173Henduseproductsonturfatthemaximum annualapplicationrateisexpectedtoposenegligibleacuterisktoaquaticandterrestrial organisms.Thisisduetothelimitedexposuretotheenvironmentresultingfromhandheldor backpacksprayersonturf,whichuseacoarsenozzlesizetominimizespraydrift.AsFeHEDTA does,however,actasaherbicideagainstbroadleafplants,aprecautionarylabelstatementis neededtopreventdamagetodesirableplants.

4 5

DIR200602,PMRAFormulantsPolicy. DIR200602,PMRAFormulantsPolicy.
Page25

7.3

Value

Thedatasubmittedareadequatetoconditionallysupporttheregistrationof theNEU1173H productsforuseonestablishedturfconsistingofoneormoreofperennialryegrass,Kentucky bluegrass,andfescueforcontrolorsuppressionofseveralbroadleavedweeds,moss,andalgae. Theavailabilityof theNEU1173Hproductsprovidesanalternativeherbicideoptionandmodeof actiontocommonlyusedherbicidesforbroadleavedweedcontrolinturf. 7.4 UnsupportedUses

Nodatawereprovidedtosupportefficacyclaimsforthefollowingweedspecies:healall (Prunellavulgaris),silvercinquefoil(Potentillaanserina),shepherdspurse(Capsellabursa pastoris),Persian speedwell(Veronicapersica),wildchamomile(Matricariachamomilla),and liverworts(variousspecies),andlichens(variousspecies).Noefficacyortolerancedatawere providedtosupportmorethantwoapplicationsperseason.Datawereinsufficienttosupportuse onnewlysownturf(turfgrassseedlings).

8.0

ProposedRegulatoryDecision

HealthCanadasPMRA,undertheauthorityofthePestControlProductsActandRegulations,is proposingfullregistrationforthesaleanduseof NEU1173HTGAIandtheenduseproducts NEU1173HRTUwithPullNSprayApplicator,NEU1173HRTUwithQuickConnectSprayer, NEU1173HRTU,FiestaLawnWeedKillerReadytoSpray,FiestaLawnWeedKiller, NEU1173HReadytoSprayLargeSize,NEU1173HReady toSpray,NEU1173HLargeSize, andNEU1173H,containingthetechnicalgradeactiveingredientironpresentasFeHEDTA (hereinreferredtoasFeHEDTA),tocontrol severalbroadleavedweedspeciesthatcommonly occurinturf. Anevaluationofavailablescientificinformationfoundthat,undertheapprovedconditionsofuse, theproducthasvalueanddoesnotpresentanunacceptablerisktohumanhealthorthe environment.

Page26

ListofAbbreviations

ListofAbbreviations
g a.i. ADI ARfD BAF BCF BW bw CAS cm DT50 dw EC50 EDE EDTA EEC EC25 EP ER50 Fe FeHEDTA g ha HDPE HEDTA HPLC HR5 HRAC IUPAC kg Kd Koc Kow L LC50 LD50 LOEC 2 m mg mL MAS MRL micrograms activeingredient acceptabledailyintake acutereferencedose BioaccumulationFactor BioconcentrationFactor Bodyweight bodyweight ChemicalAbstractsService centimetres dissipationtime50%(thedoserequiredtoobservea50%declinein concentration) dryweight effectiveconcentrationon50%ofthepopulation estimateddailyexposure ethylenediaminetetraaceticacid estimatedenvironmentalexposureconcentration effectiveconcentration on25%ofthepopulation enduseproduct effectiveratefor50%ofthepopulation iron hydroxyethylenediaminetriaceticacid,ferriccomplex gram hectare(s) highdensitypolyethylene hydroxyethylenediaminetriaceticacid highperformanceliquidchromatography th 5 percentilehazardrate HerbicideResistanceActionCommittee InternationalUnionofPureandAppliedChemistry kilogram soilwaterpartitioncoefficient organiccarbonpartitioncoefficient noctanolwaterpartitioncoefficient litre lethalconcentration50% lethaldose50% lowobservedeffectconcentration squaremetre(s) milligram millilitre maximumaveragescore maximumresiduelimit
Page27

ListofAbbreviations

NOAEL NOEC NOEL OC PCPA pKa PMRA PPE ppm PRD RDA RTU SSD t1/2 TGAI TSMP USEPA UV WSSA 2,4D

noobservedadverseeffectlevel noobservedeffectconcentration noobservedeffectlevel organiccarboncontent PestControlProductAct dissociationconstant PestManagementRegulatoryAgency personalprotectiveequipment partspermillion proposedregistrationdecision recommendeddietaryallowance readytouse Speciessensitivitydistribution halflife technicalgradeactiveingredient ToxicSubstancesManagementPolicy UnitedStatesEnvironmentalProtectionAgency ultraviolet WeedScienceSocietyofAmerica 2,4dichlorophenoxyaceticacid

Page28

AppendixI TablesandFigures
Table1
STUDY

ToxicologyProfileforFeHEDTA(26.52%w/w).*
SPECIES/STRAIN DOSES RESULT TARGET ORGAN, SIGNIFICANT EFFECTS, COMMENTS Lowtoxicity

Oral Exposurebygavage Limittest 14dayobservation

Rat Wistar 3 rats/dose Dosedat5000mg/kgbw

LD50 >5000mg/kgbw

Dermal Limittest,24hour exposurebytopical application. 14day observation

Rat Wistar 5rats/sex/dose Dosedat5000mg/kgbw

LD50 & >5000mg/kgbw

Lowtoxicity

Inhalation Limittest,4hour exposure(noseonly inhalationchamber). 14day observation Eyeirritation Draizemethod. 72hourobservation.

Rat Wistar 5rats/sex/dose Dosedat5.43mg/L

LC50 & >5.43mg/L

Lowtoxicity Slightbreathingabnormalitiesobserved duringexposure,anddiscolourationof furobservedonanimalsafterexposure.

Rabbit NewZealandWhite (3 ) Dose:0.1mLtreatedeyeleft unwashedandobservedat1 hour,24,48and72hourspost instillation.

MASa =2.2/110 MISb =4/110

Minimallyirritatingtoeye Grade1rednessofconjunctivaobserved inallanimalsat1,24,and48hour observations.Grade1chemosiswas observedinallanimalsat24hour observation.Irritationwascompletely resolvedby72hourobservation.

Dermalirritation 4hourexposure

Rabbit NewZealandWhite (3 ) Dose:0.5mL

MAS=0/8 MIS=0/8

Nonirritatingtoskin

DermalSensitization c LLNA

Mice:CBA/Ca01aHsd (5/group) Groups:25%and50%test substancewithvehicle(3:1 acetone/oliveoil),100%test substance,andvehiclecontrol.

Positive results Increaseinlymphnode weightin25%and50% d dosagegroupswithSI more than3. SI:3.2(25%) 3.2(50%) 1.3(100%) EC3valuewascalculatedto beatatestitem concentrationof33%.

Dermalsensitizer

*Testsubstance:Neu1173H(26.52%w/wFeHEDTAcontaining4.43%w/wiron)
a

MAS=MaximumAverageScorefor24,48, and72hrs MIS=MaximumIrritationScore LLNA=Locallymphnodeassay d SI =Stimulationindex

b c

Page29

Table2
STUDY

SummaryoftoxicologyfromPRD200713.
SPECIES,STRAIN ANDDOSES TARGETORGAN,SIGNIFICANT EFFECTS,COMMENTS

NOAELAND LOAEL mg/kgbw/day REPRODUCTIONANDDEVELOPMENTALTOXICITY Singlegeneration F0:0,0.5,1and5%Na2EDTAin NOAEL1% dietfor12weeks. Na2EDTA Rats(numberperdosenotdisclosed) LOAEL 5% Na2EDTA

Animalsmatedoncetheywere100daysold and10daysafterweaning. Diarrheaand o foodconsumptionat5%. Testanimalsproducednormalfirstandsecond litters,exceptat5%,wheredamsfailedto producelitters MaternalToxicity

weightloss(p<0.001) o foodconsumption(p<0.001) Severediarrheain allanimals

Developmental toxicity

0and954mgofEDTA/kgbw/day indietfordays7to14ofgestation. AdministeredNa2EDTA. CDrats

NOAEL<954mg ofEDTA/kgw/day LOAEL954mgof EDTA/kgbw/day

FetalToxicity o fetalweight(p<0.001)
meanpercentageofresorptions/litter (p<0.001) meanpercentageofmalformed fetuses/litter(p<0.001)

Grossfetalmalformationsmarkedbycleft palate,micrognathia,microphthalmia, menigocoele,phocomelia,clubfootand electrodactyly,umbilicalhernia,andshort curlytail. Internalmalformationsincludedgreatvessel anomalies,interventricularseptaldefects, smallormissinglunglobes,missingthymus, smallkidneyswithassociatedhydronephrosis andhydroureter,andsmallundifferentiated gonadslateraltothekidneys. Skeletalmalformationsincludedextreme dysplasia,includingshortened,missingor wavyribs,misalignedandfusedcentra,as wellasanomaliesassociatedwithexternal defects.Grossexternalbrainmalformations werealsonoted. Additionof100ppmzinctothediet Grossfetalmalformationsmarkedbycleftlip andpalate,hydrocephalus,anencephalus, hydranencephalus,exencephalus,microor anophthalimia,microoragnathia,clubbed legs,fusedormissingdigits,curly,shortor missingtailwerenotedinasignificantportion ofthefetuses. Additionof1000ppmzinctothediet Nofetalmalformationsobserved. GENOTOXICITY STUDY SPECIESandSTRAINorCELLTYPE ANDCONCENTRATIONSorDOSES RESULTS

Developmental toxicity

3%(w/w)ofNa2EDTAindietfrom day6to14ofgestationorfromday 6toterm. SpragueDawleyrats

Couldnotidentifya NOAELorLOAEL fromtheavailable information.

Page30

Genemutationsin bacteria

Salmonellatyphimurium strainsTA98, TA100,TA1535,TA1537,andTA1538 E.Coli WP2uvrA Upto1000g/platewithoutactivation Upto1000g/platewithactivation GENOTOXICITY SPECIESandSTRAINorCELLTYPE ANDCONCENTRATIONS orDOSES L5178YTK+/ mouselymphomacells 05000g/mlwithoutactivation 05000g/mlwithactivation L5178YTK+/ mouselymphoma cells 0325gFe/mLwithoutactivation 06.5gFe/mLwithactivation

NegativeforNa3EDTA.

STUDY

RESULTS

Genemutationsin mammaliancellsin vitro Genemutationsin mammaliancellsin vitro

NegativeforNa3EDTA.

PositiveforNaFeEDTA. Likelyduetohydroxylfreeradicalproduced fromFentonreactionoftheavailableiron, notthedirectresultofNaFeEDTA.

Table3
Property

FateandBehaviourintheEnvironment
Testsubstance Value Comments Reference PMRA#
1122092

Biotransformationin aerobicsoil Studycarriedoutin aeratedsoil suspensionsfrom5 typesofsoilsof differentpHs.

FeEDTA Reaction betweenFeand Na14Clabeled EDTA

Biotransformation pH5.7&6.1 7590% persistent* remainingafter30d pH6.75 1520% slightly remainingafter30d persistent* <5% non remainingafter30d persistent*

pH7.3&7.85

Biotransformationin anaerobicsoil Studycarriedoutin anaerobicsoilsfrom3 typesofagricultural soilsofdifferentpHs. Adsorption/ desorptioninsoil Studycarriedouton Rehovotsand(sand, 88%silt,5%clay, 7%)[pH7.17.2]in Batchesequilibrium studiesandcolumn studies.Onlyresults fromcolumnstudies werevalid.

FeEDTA

pH6.0 not transformed

stable 1566548 (noCO2 was produced)

Reaction betweenFeCl3 saltand 14 [ C]EDTA FeEDTA

pH6.4 pH7.4

Mobility Kdads Kdads:0.57 valuesofKd wereestimated frombreak throughcurves ofcolumn experiments NoKoc was calculated

highly mobilein sand

1566532

Table4
Organism

ToxicitytoNonTargetSpecies
Exposure Testsubstance Endpointvalue
Page31
a Degreeoftoxicity

Reference PMRA#

Organism

Exposure

Testsubstance

Endpointvalue

a Degreeoftoxicity

Reference PMRA# 1566585

Terrestrial NOEL:12.5g Relativelynontoxic FeHEDTA/bee LD50:83.68g FeHEDTA/bee Contact NEU1173H NOEC:100g Relativelynontoxic FeHEDTA/bee LC50 >100g FeHEDTA/bee Acute NEU1173H LD50 >530.4mg Slightlytoxicity Birds: FeHEDTA/kgbw Bobwhitequail NOEL:132.6mg FeHEDTA/kgbw Dietary NEU1173H LD50 >307.13mg Notoxicityatthe FeHEDTA/kgbw/day highestdose NOEL:307.13mg FeHEDTA/kgbw/day Rat Acuteoral NEU1173H LD50 >1326mg Notoxicityatthe FeHEDTA/kgbw highestdose Aquatic NEU1173H EC50>27.7mg Notoxicityatthe Invertebrates: Acute Daphniamagna FeHEDTA/L highestconcentration NOEC:27.7mg FeHEDTA/L Acute NEU1173H LC50>27.7mg Notoxicityatthe Fish: Rainbowtrout FeHEDTA/L highestconcentration NOEC:27.7mg FeHEDTA/L a Atkinsetal.(1981)forbeesandUSEPAclassificationforothers,whereapplicable b containing26.52%FeHEDTA. Invertebrates: Bee Oral
b NEU1173H

1566585

1566588

1566589

1566576

1566586

1566587

Table5
Earthworm Bees Othernontarget arthropods Birds

Endpointsusedforriskassessmentandtheuncertaintyfactorsapplied
Exposure Acute Chronic Acute Acute Acuteoral Dietary Reproduction Acuteoral Reproduction Acute Acute Chronic Endpoint LC50 NOEC LD50 LR50 LD50 LD50 NOEL LD50 NOEL HR5 ofSSDofER506 EC50 NOEC Uncertainty Factor 0.5 1.0 1.0 1.0 0.1 0.1 1.0 0.1 1.0 1.0 0.5 1.0

Taxonomicgroup

Mammals Nontargetterrestrial plants Aquaticinvertebrates

6 th

5 percentilehazardrateofthespeciessensitivitydistributionofER50values
Page32

Taxonomicgroup Fish Amphibians Algae Aquaticvascularplants

Exposure Acute Chronic Acute Chronic Chronic Chronic

Endpoint LC50 NOEC FishLC50 FishNOEC EC50 EC50

Uncertainty Factor 0.1 1.0 0.1 1.0 0.5 0.5

Table6

ScreeningLevelRiskAssessmentonNontargetSpecies
Foodguild Infield EDE(mg FeHEDT A /kgbw)
7082.6 1770.6 3541.3 7082.6 1770.6 3541.3 5527.2 1381.8 1381.8 2763.6 5527.2 1381.8 1381.8 2763.6 1613.7 403.4 403.4 806.8 5767.4 3521.4 5336.1 10869.8 Page33

Riskstobirdsandmammals Exposure Toxicity type endpoint (mg FeHEDTA /kgbw/d) Smallbirds(0.02kg)

Acute

Offfield EDE(mg FeHEDT A/kgbw) RQ

RQ

LOC exceeded In Off field field

53.04 53.04 53.04

Dietary

307.13 307.13 307.13

Insectivore(small insects) Granivore(grainand seeds) Frugivore(fruit) Insectivore(small insects) Granivore(grainand seeds) Frugivore(fruit) Insectivore(small insects) Insectivore(largeinsects) Granivore(grainand seeds) Frugivore(fruit) Insectivore(small insects) Insectivore(largeinsects) Granivore(grainand seeds) Frugivore(fruit) Insectivore(small insects) Insectivore(largeinsects) Granivore(grainand seeds) Frugivore(fruit) Herbivore(shortgrass) Herbivore(longgrass) Herbivore(foragecrops) Herbivore(leafyfoliage)

133.5 33.3 66.7 23.0 5.7 11.5 104.2 26.0 26.0 52.1 17.9 4.4 4.4 8.9 30.4 7.6 7.6 15.2 108.7 66.4 100.6 204.9

212.4 53.1 106.2 212.4 53.1 106.2 165.8 41.4 41.4 82.9 165.8 41.4 41.4 82.9 48.4 12.1 12.1 24.2 173.0 105.6 160.0 326.0

4.0 1.0 2.0 0.7

Yes No Yes

0.1 0.3 3.1 0.7 0.7 1.5 0.5 0.1 0.1 0.2 0.9 0.2 0.2 0.4 3.2 1.9 3.0 6.1
No Yes No Yes No Yes

MediumSizedBird(0.1kg)
Acute 530.4 530.4 530.4 530.4 Dietary 307.13 307.13 307.13 307.13

LargeSizedBirds(1kg)
Acute 530.4 530.4 530.4 530.4 530.4 530.4 530.4 530.4

Yes Yes

Riskstobirdsandmammals Exposure Toxicity type endpoint (mg FeHEDTA /kgbw/d)

Dietary 307.13 307.13 307.13 307.13 307.13 307.13 307.13 307.13 Acute 1326 1326 1326 Acute 1326 1326 1326 1326 1326 1326 1326 1326 Acute 1326 1326 1326 1326 1326 1326 1326 1326

Foodguild

Infield EDE(mg FeHEDT A /kgbw)

1613.7 403.4 403.4 806.8 5767.4 3521.4 5336.1 10869.8 4073.6 1018.4 2036.8 3571.0 892.7 892.7 1785.5 12762.9 7792.7 11808.4 24054.2 1908.1 477.0 477.0 954.0 6819.6 4163.9 6309.6 12852.9

Offfield EDE(mg FeHEDT A/kgbw)

48.4 12.1 12.1 24.2 173.0 105.6 160.0 326.0 122.2 30.5 61.1 107.1 26.7 26.7 53.5 382.8 233.7 354.2 721.6 57.2 14.3 14.3 28.6 204.5 124.9 189.2 385.5

RQ

RQ

LOC exceeded In Off field field

Insectivore(small insects) Insectivore(largeinsects) Granivore(grainand seeds) Frugivore(fruit) Herbivore(shortgrass) Herbivore(longgrass) Herbivore(foragecrops) Herbivore(leafyfoliage) Insectivore(small insects) Granivore(grainand seeds) Frugivore(fruit) Insectivore(small insects) Insectivore(largeinsects) Granivore(grainand seeds) Frugivore(fruit) Herbivore(shortgrass) Herbivore(longgrass) Herbivore(foragecrops) Herbivore(leafyfoliage) Insectivore(small insects) Insectivore(largeinsects) Granivore(grainand seeds) Frugivore(fruit) Herbivore(shortgrass) Herbivore(longgrass) Herbivore(foragecrops) Herbivore(leafyfoliage)

5.2 1.3 1.3 2.6 18.7 11.4 17.3 35.4

3.0 0.7 1.5 2.7 0.6 0.6 1.3 9.6 5.8 8.9 18.1 1.4 0.3 0.3 0.7 5.1 3.1 4.7 9.7

0.1 0.0 0.0 0.0 0.5 0.3 0.5 1.0

0.1 0.0 0.0 0.0 0.0 0.0 0.0 0.2 0.1 0.2 0.5 0.0 0.0 0.0 0.0 0.1 0.1 0.1 0.2 No No No No Yes No Yes Yes No No No

Yes

SmallMammal(0.015kg)

MediumSizedMammal(0.035kg)

Yes

LargeSizedMammal(1kg)
Yes

Yes

Table7

ScreeningLevelRiskAssessmentonNonTargetSpecies
Endpointvalue(mg FeHEDTA/L) EC50 2>13.85 LC50 >27.7 LC50 >27.7
Page34

Risktoaquaticorganisms Organism Exposure Freshwaterspecies Daphniamagna Rainbowtrout Amphibian

EEC (mgFeHEDTA/L) 7.8 7.8 41.6

RQ

LOC exceeded No No Yes

Acute Acute Acute

<0.56 <0.28 <1.5

Table8

RefinedRiskAssessmentonNonTargetSpecies
Foodguild Infield EDE(mg FeHEDTA /kgbw) 2156.1 460.9 921.9 2156.1 460.9 921.9 1682.6 359.7 359.7 719.4 1682.6 359.7 359.7 719.4 491.2 105.0 105.0 210.0 1118.0 627.6 962.9 1961.4 491.2 105.0 105.0 210.0 1118.0 627.6 962.9 1961.4 1240.1 1087.1 464.8 2474.2 1388.9 2130.8 4340.6 580.8 1322.0521 Page35 Meannomogramresidues Offfield RQ LOC EDE(mg RQ exceeded FeHEDT A/kgbw) 40.6 8.6 17.3 7.0 1.5 3.0 31.7 6.7 6.7 13.5 5.4 1.1 1.1 2.3 9.2 1.9 1.9 3.9 21.0 11.8 18.1 36.9 1.5 0.3 0.3 0.6 3.6 2.0 3.1 6.3 0.9 0.8 0.3 1.8 1.0 1.6 3.2 0.4 0.9 64.6 13.8 27.6 64.6 13.8 27.6 50.4 10.7 10.7 21.5 50.4 10.7 10.7 21.5 14.7 3.15 3.1 6.3 33.5 18.8 28.8 58.8 14.7 3.1 3.1 6.3 33.5 18.8 28.8 58.8 37.2 32.6 13.9 74.2 41.6 63.9 130.2 1.2 0.2 0.5 0.2 0.0 0.1 0.9 0.2 0.2 0.4 0.1 0.0 0.0 0.0 0.2 0.0 0.0 0.1 0.6 0.3 0.5 1.1 0.0 0.0 0.0 0.0 0.1 0.0 0.0 0.1 0.0 0.0 0.0 0.0 0.0 0.0 0.0

RefinedRiskstobirdsandmammals
Exposure Toxicity type endpoint (mg FeHEDTA /kgbw/d) SmallBirds(0.02kg) Acute 53.04

LOC exceeded

Insectivore(smallinsects) Granivore(grainandseeds) 53.04 Frugivore(fruit) 53.04 Dietary Insectivore(smallinsects) 307.13 Granivore(grainandseeds) 307.13 Frugivore(fruit) 307.13 MediumSizedBirds(0.1kg) 53.04 Insectivore(smallinsects) Acute 53.04 Insectivore(largeinsects) 53.04 Granivore(grainandseeds) 53.04 Frugivore(fruit) Dietary Insectivore(smallinsects) 307.13 Insectivore(largeinsects) 307.13 Granivore(grainandseeds) 307.13 Frugivore(fruit) 307.13 LargeSizedBirds(1kg) 530.4 Insectivore(smallinsects) Acute 530.4 Insectivore(largeinsects) 530.4 Granivore(grainandseeds) 530.4 Frugivore(fruit) 530.4 Herbivore(shortgrass) 530.4 Herbivore(longgrass) 530.4 Herbivore(foragecrops) 530.4 Herbivore(leafyfoliage) 307.13 Insectivore(smallinsects) Dietary 307.13 Insectivore(largeinsects) 307.13 Granivore(grainandseeds) 307.13 Frugivore(fruit) 307.13 Herbivore(shortgrass) 307.13 Herbivore(longgrass) 307.13 Herbivore(foragecrops) 307.13 Herbivore(leafyfoliage) SmallMammal(0.015kg) 1326 Insectivore(smallinsects) Acute MediumSizedMammals(0.035kg) 1326 Insectivore(smallinsects) Acute 1326 Frugivore(fruit) 1326 Herbivore(shortgrass) 1326 Herbivore(longgrass) 1326 Herbivore(foragecrops) 1326 Herbivore(leafyfoliage) LargeSizedMammals(1kg) Acute 1326 Insectivore(smallinsects) 1326 Herbivore(shortgrass)

Yes

Yes

No

No

Yes

No

Yes

Yes

No

No

Yes

No No

No

Yes

No

17.4
39.6

0.0
0.0 No

RefinedRiskstobirdsandmammals
Exposure Toxicity type endpoint (mg FeHEDTA /kgbw/d) 1326 1326 1326 Foodguild Infield EDE(mg FeHEDTA /kgbw) 742.1880 1138.5844 2319.3386 Meannomogramresidues Offfield RQ LOC EDE(mg exceeded FeHEDT A/kgbw) 0.5 22.2 0.8 34.1 1.7 69.5 Yes

RQ

LOC exceeded

Herbivore(longgrass) Herbivore(foragecrops) Herbivore(leafyfoliage)

0.0 0.0 0.0

Table9

ToxicSubstancesManagementPolicy(TSMP)ConsiderationsComparison toToxicSubstancesManagementPolicy
TSMPTrack 1Criterionvalue Yes Yes Soil Water Halflife 182days Halflife 182days ActiveIngredient Endpoints Yes Yes Notexpectedtobepersistent

TSMPTrack1 Criteria CEPAtoxicorCEPA 1 toxicequivalent Predominantly 2 anthropogenic 3 Persistence :

1456.8min

Sediment Halflife <5d(aerobicaquaticsystem) 365days Air Halflife 2daysor Notexpectedtobevolatile evidenceoflongrange transport 4 Bioaccumulation LogKOW5 <0 BCF5000 Notrequired BAF5000 Notrequired IsthechemicalaTSMPTrack1substance(allfourcriteria No,doesnotmeetTSMPTrack1criteria. mustbemet)? 1 AllpesticideswillbeconsideredCEPAtoxicorCEPAtoxicequivalentforthepurposeofinitially assessingapesticideagainsttheTSMPcriteria.AssessmentoftheCEPAtoxicitycriteriamayberefinedif required(idest,allotherTSMPcriteriaaremet). 2 Thepolicyconsidersasubstancepredominantlyanthropogenicif,basedonexpertjudgment,its concentrationintheenvironmentmediumislargelyduetohumanactivity,ratherthantonaturalsourcesor releases. 3 Ifthepesticideand/orthetransformationproduct(s)meetonepersistencecriterionidentifiedforone media(soil,water,sedimentorair)thanthecriterionforpersistenceisconsideredtobemet. 4 Fielddata(exempligratia,BAFs)arepreferredoverlaboratorydata(exempligratia,BCFs)which,in turn,arepreferredoverchemicalproperties(exempli gratia,logKOW).

Figure1.StructuralformulasofEDTAandHEDTA.

Page36

EDTA HEDTA (ethylenediaminetetraaceticacid)(hydroxyethylethylenediaminetriaceticacid)

Page37

References

References
A. ListofStudies/InformationSubmittedbyRegistrant 1.0
PMRA Document Number 1753329

Chemistry
Reference

17533292009,Binder2Amended,DACO:2.0,2.1,2.11,2.11.1,2.11.2,2.11.3,2.11.4,2.12, 2.12.1,2.12.2,2.13,2.13.1,2.13.2,2.13.3,2.13.4,2.14,2.14.1,2.14.10,2.14.11,2.14.12, 2.14.13,2.14.14,2.14.2,2.14.3,2.14.4,2.14.5,2.14.6,2.14.7,2.14.8,2.14.9,2.15,2.16,2.2, 2.3,2.3.1,2.4,2.5,2.6,2.7,2.8,2.9CBI 2009,NEU1173HTGAIClarificationResponse,DACO:0.1.6003,2.11.2,2.11.3,2.12.2, 2.13.1CBI 2009,5batchAnalysisofNEU1173HTGAIHEDTA,DACO:2.13.3CBI 2009,5BatchAnalysisofNeu1173HTGAI,DACO:2.13,2.13.1,2.13.2,2.13.3CBI 2009,5BatchAnalysisofNeu1173HTGAIAppendices,DACO:2.13,2.13.1,2.13.2,2.13.3 CBI 2009,5BatchAnalysisofNeu1173HTGAIforNitrilotriacetate,Ethylenediaminetetraacetate andHydroxyacetate,DACO:2.13,2.13.1,2.13.2,2.13.3CBI 2009,AnalysisofIroninNEU1173HbyICPMSinsupportofEcoCareStudy11732W54 2M40081216"Accelerated(wweeks54C,2months40C)StorageStabilityofNEU1173H", DACO:2.14.14CBI 2007,MethodSOPIC/003,DACO:2.13.1CBI 2008,MethodSOP91CM00600,DACO:2.13.1CBI 2009,NEU1173HTGAIChromatograms,DACO:2.11.3CBI 2009,NEU1173HTGAIClarificationResponse,DACO:0.1.6003,2.11.2,2.11.3,2.12.2, 2.13.1CBI Binder2AddendumJune23,2009,DACO:2.0,2.11.4,2.12,2.12.1,2.12.2,2.13,2.13.1, 2.13.2,2.13.3,2.13.4CBI 2008,Binder2,DACO:2.0,2.1,2.11,2.11.1,2.11.2,2.11.3,2.11.4,2.12,2.12.1,2.12.2, 2.13,2.13.1,2.13.2,2.13.3,2.13.4,2.14,2.14.1,2.14.10,2.14.11,2.14.12,2.14.13, 2.14.14,2.14.2,2.14.3,2.14.4,2.14.5,2.14.6,2.14.7,2.14.8,2.14.9,2.2,2.3,2.3.1, 2.4,2.5,2.6,2.7,2.8,2.9CBI 2008,Ambient(1year)StorageStabilityofNEU1173H,DACO:2.14.14CBI 2009,UVVisibleAbsorption,DACO:2.14.12CBI 2009,Binder2Addendum,DACO:3.0,3.2.1,3.2.2,3.3.1,3.3.2,3.4,3.4.1,3.5,3.5.10,3.5.6, 3.5.7,3.5.8,3.7CBI 2008,CBIReferenceDocumenttoBinder2,DACO:3.2.1,3.2.2,3.3.1CBI

1791534 1753341 1768339 1768340 1768341 1753345

1791535 1791536 1791537 1791534 1768838 1566571

1566574 1753343 1753390 1566835

Page39

References

1566831

2008,Binder2,DACO:3.0,3.1,3.1.1,3.1.2,3.1.3,3.1.4,3.2,3.2.1,3.2.2,3.2.3,3.3.1,3.3.2, 3.4,3.4.1,3.4.2,3.5,3.5.1,3.5.10,3.5.11,3.5.12,3.5.13,3.5.14,3.5.15,3.5.2,3.5.3,3.5.4, 3.5.5,3.5.6,3.5.7,3.5.8,3.5.9 2008,Ambient(1year)StorageStabilityofNEU1173HRTU,DACO:3.5.10 2008,PhysicalandChemicalCharacteristics:Oxidation/Reduction,DACO:3.5.8CBI 2009,AnalysisofIroninNeu1173HRTUbyICPMSinsupportofecoCareStudy1173RTU 2W542M40081216"Accelerated(2weeks,54C,2months,40C)StorageStabilityof NEU1173HRTU,DACO:3.5.10CBI 2009,StorageStabilityData,DACO:3.5.10CBI 2009,Binder2Addendum,DACO:3.0,3.2.1,3.2.2,3.3.1,3.3.2,3.4,3.4.1,3.5,3.5.10,3.5.6, 3.5.7,3.5.8,3.7CBI 2009,AnalysisofIroninNeu1173HbyICPMSinsupportofecoCareStudy11732W54 2M40081216"Accelerated(2weeks,54C,2months,40C)StorageStabilityofNEU1173H", DACO:3.5.10CBI 2008,Binder2,DACO:3.0,3.1,3.1.1,3.1.2,3.1.3,3.1.4,3.2,3.2.1,3.2.2,3.2.3,3.3.1,3.3.2, 3.4,3.4.1,3.4.2,3.5,3.5.1,3.5.10,3.5.11,3.5.12,3.5.13,3.5.14,3.5.15,3.5.2,3.5.3,3.5.4, 3.5.5,3.5.6,3.5.7,3.5.8,3.5.9 2008,StorageStability1year,DACO:3.5.10 2008,PhysicalandChemicalCharacteristics:Oxidation/Reduction,DACO:3.5.8CBI 2009,StorageStabilityData,DACO:3.5.10CBI

1566834 1753394 1753395

1790668 1753404 1753410

1567217

1567219 1753409 1790663

2.0
1566576 1566578 1566579 1566580 1566581 1566582

HumanandAnimalHealth
2006,AcuteoraltoxicitylimittestwithNEU1173H,DACO:4.6.1. 2006,Acutedermaltoxicity(limittest)withNEU1173H,DACO:4.6.2. 2007,Acute(4hour)inhalationtoxicitystudywithNEU1173Hinrats,DACO:4.6.3. 2007,AcuteEyeIrritation/CorrosionwithNEU1173H,DACO:4.6.4. 2006,AcuteDermalIrritation/CorrosionwithNEU1173H,DACO:4.6.5. 2006,TestforSensitization(LocalLymphNodeAssay LLNA)withNEU1173H, DACO:4.6.6. 2009,MSDSNEU1173HTGAI,DACO:0.9. DowChemicalCompany,2007,MSDSVersenol120ChelatingAgent,DACO:0.9.1. SigmaAldrich,2006,MSDSEthylenediamineN,NDiaceticAcid,DACO:0.9.1. 2009,Binder#3Addendum,DACO:4.3.4,4.5.2,4.5.4,4.5.5,4.8.
Page40

1753319 1753320 1753323 1753351

References

1753352 1753353 1753354 1753355 1753356 1753357 1753358

2007,USAEPADER:AcuteOralToxicity Rat,DACO:4.8. 2007,USAEPADER:AcuteDermalToxicity Rat,DACO:4.8. 2007,Acute(4hour)InhalationToxicityStudywithNEU1173HinRats,DACO:4.8. 2007,DER:PrimaryEyeIrritation Rabbit,DACO:4.8. 2007,DER:PrimaryDermalIrritation Rabbit,DACO:4.8. 2007,DER:SkinSensitization GuineaPig,DACO: 4.8. Candela,E.et.al.,1984,IronAbsorptionbyHumansandSwinefromFe(III)EDTA. FurtherStudies,Candela,E.,etal.,IronAbsorptionbyHumansandSwinefromFE(111) EDTA.FurtherStudies,J.Nutr.114:22042211,1984.,DACO:4.8. Dunkel,V.C,etal,GenotoxicityofIronCompoundsinSalmonellatyphimuriumand L5178YMouseLymphomaCells,EnvironmentalandMolecularMutagenesis33:2841 (1999). USEPA,2006,FiftyEighthReportoftheTSCAInteragencyTestingCommittee tothe AdministratoroftheEPAReceiptofReportandRequestforCommentsNotice, EnvironmentalProtectionAgency,FiftyEighthReportoftheTSCAInteragencyTesting Committee. USEPA,2005,FerricSodiumEDTANoticeofFilingaPesticidePetitiontoEstablisha ToleranceforaCertainPesticideChemicalinoronFood,EnvironmentalProtection Agency. Heimbach,J.et.al.,1999,SafetyAssessmentofIronEDTA[SodiumIron(Fe3+) EthylenediaminetetraaceticAcid]:SummaryofToxicological,FortificationandExposure Data. Kimmel,C.A.,1976,EffectofRouteofAdministrationontheToxicityandTeratogenicity ofEDTAintheRat,ToxicologyandAppliedPharmacology40,299306(1977). McGregor,D.B.et.al.,1988,ResponsesoftheL5178Ytk+/tkMouselymphomaCell ForwardMutationAssay:III.72CodedChemicals. NationalCancerInstitute,1977,BioassayofTrisodiumEthylenediaminetetraacetate Trihydrate(EDTA)forPossibleCarcinogenicity,NationalCancerInstitute, Carcinogenesis,TechnicalReportSeries,No.11,1977. Oser,B.L.etal,1962,SafetyEvaluationStudiesofCalciumEDTA,Toxicologyand AppliedPharmacology5,142162(1963),DACO:4.8. Swenerton,H.andL.S.Hurley,1971,TeratogenicEffectsofaChelatingAgentandtheir
Page41

1753359

1753360

1753361

1753362

1753363

1753364

1753365

1753366

1753368

References

PreventionbyZinc,DACO:4.8. 1753369 1753370 Munro,I.C.,2005,SodiumIronEDTA(WHOFoodAdditivesSeries32),DACO:4.8. Yang,S.S.andM.S.Chan,1964,SummariesofToxicologicalData:Toxicologyof EDTA,Yang,S.S.andM.S.Chan,SummariesofToxicologicalData:Toxicologyof EDTA,FdCosmet,Toxicol.Vol.2,pp.763767.PergamonPress1964,PrintedinGB, DACO:4.8. USEPA,2008,IronHEDTA,BiopesticidesRegistrationActiondocument.DACO: 12.5.2,12.5.4,12.5.8,12.5.9,2.16,4.8,8.6,9.9. 2009,Proposition65Assessments:NitrilotriaceticAcidinNeudorffNEU1173HRTU andNEU1173HConcentrate,DACO:2.13.4CBI. 2009,Proposition65AssessmentNeudorff,DACO:2.13.4CBI DACO5.2.(UsedescriptionScenario).Clarificationresponse,EcoCareTechnologiesInc. Saanichton.CA.August122009. DACO5.2.(UsedescriptionScenario).Clarificationresponse,EcoCareTechnologiesInc. Saanichton.CA.August122009. DACO5.2.(UsedescriptionScenario).Clarificationresponse,EcoCareTechnologiesInc. Saanichton.CA.August122009. DACO5.2.(UsedescriptionScenario).Clarificationresponse,EcoCareTechnologiesInc. Saanichton.CA.August122009. DACO5.2.(UsedescriptionScenario).Clarificationresponse,EcoCareTechnologiesInc. Saanichton.CA.August122009.

1753380

1768343

1768344 1789702

1789703

1789690

1789692

1789706

3.0

Environment

PMRA# Reference 1566526 Anonymous,1993,ReregistrationEligibilityDocument,IronSalts,DACO:0.17 1566530 R.T.Belly,J.J.LauffandC.T.Goodhue,1975,Degradationofethylenedieminetetraaceticacid bymicrobialpopulationsfromanaeratedlagoon,AppliedMicrobiology,Vol26,No.6pages787794, DACO:0.17,8.6 1566532 M.BucheliWitschelandT.Egli,2001,Environmentalfateandmicrobialdegradationof aminopolycarboxylicacids,FEMSMicrobiologyReviews,Vol25,DACO:0.17,8.6 1566534 R.FrankandH.Rau,1990,PhotochemicalTransformationinAqueousSolutionandPossible EnvironmentalFateofEthylenediaminetetraaceticacid(EDTA),EcotoxicologyandEnvironmental Safety,Vol19,pp9.DACO:0.17,8.6 1566537 F.G.Kari,S.HilgerandS.Canonica,1995,DeterminationoftheReactionQuantumYieldforthe PhotochemicalDegradationofFe(III)EDTA:ImplicationsfortheEnvironmentalFateofEDTAin SurfaceWaters,EnvironmentalScienceandTechnology,Vol229,pp10.DACO:0.17,8.6

Page42

References

1566538 J.J.Lauff,D.B.Steele,L.A.CooganandJ.MBreitfeller,1990,DegradationoftheFerricChelateof EDTA byaPureCultureofanAgrobacteriumsp.,AppliedandEnvironmentalMicrobiology,Vol56, No11,pp8.DACO:0.17,8.6 1566540 H.B.Lockhart,Jr.,andR.V.Blakeley,1975,AerobicPhotodegradationofFe(III)(Ethylenedinitrilo) tetraacetate (FericEDTA),EnvironmentalScienceandTechnology,Vol9,No12,pp4.DACO: 0.17,8.6 1566544 A.Svenson,L.KajandH.Bjorndal,1989,Aqueousphotolysisoftheiron(III)complexesofNTAS, EDTAandDTPA,Chemosphere,Vol18,No9/10,pp4.DACO:0.17,8.6 1566545 V.Sykora,P.Pitter,I.BittnerovaandT.Lederer,2001,BiodegradabilityofEthylenediamineBased ComplexingAgents,WaterResearch,Vol35,No8,pp8.DACO:0.17,8.6 1566546 R.A.P.Thomas,K.Lawlor,M.BaileyandL.E.Macaskie,1998,BiodegradationofMetalEDTA ComplexesbyanEnrichedMicrobialPopulation,AppliedandEnviromentalMicrobiology,Vol64, No4,pp4.DACO:0.17,8.6 1566547 J.M.Tiedje,1975,MicrobialdegradationofEthylenediaminetetraacetateinsoilsandsediments, AppliedMicrobiology,Vol30,No2,pp3.DACO:0.17,8.6 1566548 J.M.Tiedje,1977,InfluenceofEnvironmentalParametersonEDTABiodegradationinSoilsand Sediments,JournalofEnvironmentalQuality,Vol6,No1,pp6.DACO:0.17,8.6 1566566 2004,MSDSDissolvineH88X,DACO:0.9.1 1566569 2003,MSDSDissolvineHFE4.5,DACO:0.9.1 1566583 2008,Part8EnvironmentalChemistryandFate,DACO:8.1,8.2,8.2.1,8.2.2,8.2.2.1,8.2.2.2, 8.2.2.3,8.2.2.4,8.2.3,8.4,8.4.1,8.5,8.5.1,8.6 1566584 2008,Part9EnvironmentalToxicology: DACO:9.1,9.2.1,9.2.3,9.2.4.1,9.2.4.2,9.2.4.3,9.2.5,9.2.6,9.2.7, 9.3.1,9.3.2,9.4.1,9.5.1,9.5.2,9.5.2.1,9.5.2.2,9.5.3,9.6.1,9.6.2.1,9.6.2.4,9.6.2.5,9.6.3,9.7,9.8.1,9.9 1566585 2007,AssessmentofSideEffectsofNEU1173HtotheHoneyBee,ApismelliferaL.intheLaboratory, DACO:9.2.4.1,9.2.4.2 1566586 2007,AssessmentofToxicEffectsofNEU1173HonDaphniamagnausingthe48hAcute ImmobilisationTest,DACO:9.3.2 1566587 2007,AcuteToxicityTestingofNEU1173HinRainbowTrout(Oncorhynchusmykiss),DACO: 9.5.2.1 1566588 2007,AvianAcuteOralToxicityStudyofNEU1173H Bobwhitequail,DACO:9.6.2.1 1566589 2007,AvianDietaryToxicityStudyofNEU1173HbyOralAdministrationviathediettobirds (Bobwhitequail),DACO:9.6.2.4 1566590 2008,Part12ComprehensiveDataSummariesNEU1173HTGAI,DACO:12.7 1753350 Lockhart,Jr.,H.B.andR.V.Blakeley,1975,AerobicPhotodegradationofFe(III)(ethylenedinitrilo) tetraacetate(FerricEDTA)ImplicationsforNaturalWaters,DACO2.16 1753371 2009,Part8,EnvironmentalChemistryandFate,DACO:8.6 1753372 2007,DataEvaluationRecordNEU1173H:Fate,TransportandTransformation,DACO:8.6 1753373 2007,Binder#5AddendumPart9,EnvironmentalToxicology,DACO:9.9 1753374 2007,DataEvaluationRecordNEU1173H(IronHEDTA)HoneybeeTesting,TierI,DACO:9.9 1753375 2007,DataEvaluationRecordNEU1173H(IronHEDTA)Honeybeeacutecontacttoxicity,DACO: 9.9 1753376 2007,DataEvaluationRecordNEU1173H:(IronHEDTA)AquaticInvertebrateAcuteToxicity, DACO:9.9 1753377 2007,DataEvaluationRecordNEU1173H(IronHEDTA)FreshwaterFishAcuteToxicity,DACO: 9.9 1753378 2007,DataEvaluationRecordNEU1173H(IronHEDTA)AvianAcuteOralToxicityStudy,DACO: 9.9 1753379 2007,DataEvaluationRecordNEU1173H(IronHEDTA)AvianDietaryStudy,DACO:9.9 1753380 2008,BiopesticidesRegistrationActiondocument,DACO: 12.5.2,12.5.4,12.5.8,12.5.9,2.16,4.8,8.6,9.9
Page43

References

1763724 Lockhart,Jr.,H.B.andR.V.Blakeley,1975,AerobicPhotodegradationofFe(III) (Ethylenedinitrilo)tetraacetate(FerricEDTA),DACO:2.16 1768345 Lockhart,Jr.,H.B.andR.V.Blakeley,1975,AerobicPhotodegradationofFe(III) (Ethylenedinitrilo)tetraacetate(FerricEDTA),DACO:2.16

4.0

Value
2008.Binder4Value. 2008.RevisedBinder#4:Part10,Value EIP.

1634529 1618279

B. i)

AdditionalInformationConsidered PublishedInformation 1.0 Chemistry

Anonymous,DissolvineProductGuideAkzoNobelSept.2007

2.0
1805169

HumanandAnimalHealth
2007.EncyclopediaofFoodAdditivesDACO:4.8 http://www.bizlink.com/foodfiles/PDFs/food_additives_2007.pdf 1990,NitrilotriaceticAcid(NTA),DACO:4.8 Whittaker,P.etal.,2001,GenotoxicityofIronChelatorsinL5178YMouse LymphomaCells,EnvironmentalandMolecularMutagenesis38:347356 (2001),DACO:4.8 Eaton,J.W.andQian,M.,2002,SerialReview:IronandCellularRedox Status.GuestEditor:MarioComporti.MOLECULARBASESOF CELLULARIRONTOXICITY,FreeRadicalBiology&Medicine,Vol.32, No.9,pp.833840,2002,DACO:4.8 Emerit,J.etal.,2001,Ironmetabolism,freeradicals,andoxidativeinjury, BiomedPharmacother200155:3339,DACO:4.8 U.S.EPA,1993,EPAR.E.D.FACTSIronSalts,DACO:4.8 2009,http://www.inchem.org/documents/jecfa/jecmono/v18je18.htm13/, 571.Iron (WHOFoodAdditivesSeries18) http://www.inchem.org/documents/jecfa/jecmono/v18je18.htm13/,DACO:4.8 http://ijt.sagepub.com/cgi/content/abstract/21/2_suppl/95,FinalReporton theSafetyAssessmentofEDTA,CalciumDisodiumEDTA,Diammonium EDTA,DipotassiumEDTA,DisodiumEDTA,TEAEDTA,Tetrasodium EDTA,TripotassiumEDTA,TrisodiumEDTA,andHEDTA
Page44

1811894 1811903

1811906

1812862

1812884 1812895

1812903

References

1812911

Pra,Detal.,2007,Genotoxicityandmutagenicityofironandcopperin mice,Biometals(2008)21:289297,DACO:4.8

3.0

Value

Romheld,V.andH.Marschner.1986.EvidenceforaSpecificUptakeSystemforIronPhytosiderophoresinRoots ofGrasses.PlantPhysiol.80:175180.

Page45

PMRA APPROVED - LP 2008-0952 2010-04-14

Please note that the highlighted text has been updated by the PMRA on your behalf. Please update your label accordingly.

NEU1173H RTU WITH PULLN SPRAY APPLICATOR Solution DOMESTIC READY-TO-USE SELECTIVE HERBICIDE GUARANTEE: Iron (present as FeHEDTA) 0.25%

Contains 5-chloro-2-methyl-4-izothiazolin-3-one at 0.0007571% and 2-methyl-4-izothiazolin-3-one at 0.0002479%, as preservatives

REG. NO.: 29531 P.C.P. ACT READ THE LABEL BEFORE USING KEEP OUT OF REACH OF CHILDREN POTENTIAL SKIN SENSITIZER NET CONTENTS: 5 L Registrant: W. Neudorff GmbH KG An der Muhle 3, Postfach 1209 D-31860 Emmerthal, Germany www.neudorff.com Canadian Agent: Eco-Care Technologies Inc., 8233 Thomson Pl, Saanichton, BC V8M 1S1 Telephone: 250-652-5510

For use on lawn turf consisting of one or more of Kentucky bluegrass, perennial ryegrass, and fescue (tall fescue, chewings fescue, and/or creeping fescue) for control or suppression of broadleaf weeds. PESTS/SITES: Controls the following lawn weeds: Dandelion, English daisy, False dandelion, White clover, Black medic, Bull thistle, Canada thistle, Common chickweed, Creeping buttercup, Slender speedwell, Narrow-leaved plantain, Broad-leaved plantain (suppression only), Dove's-foot geranium, Lawn burweed, Moss, and Algae. With pressure sprayer. [Text for inside Arrow]
PullN Spray Applicator [ILLUSTRATION #1] Remove sprayer from side carrier and unwrap hose completely. Insert plug at end of hose into spout on cap until it clicks. Flip up spout.

ILLUSTRATION #2] Point sprayer away from body. Grasp sprayer by the handle. SLOWLY pull ring at bottom of sprayer handle until it stops to ready the sprayer.

[ILLUSTRATION #3] Twist nozzle at end of sprayer to adjust spray pattern.

[ILLUSTRATION #4] Press button on sprayer to begin spraying and hold down for continuous spray. Pull ring at sprayer bottom again as needed for additional spraying.

DIRECTIONS FOR USE SHAKE WELL BEFORE USING. Do not dilute. Follow illustrations and instructions to ready the sprayer. Twist nozzle at end of sprayer to open and adjust spray pattern. Point sprayer away from body and press sprayer button to begin spraying. Pull ring at base of sprayer as needed to continue spraying. Hold down for continuous spray. Spray weeds until foliage is thoroughly wetted, just to the point of run-off. Repeat treatment once in four or more weeks after the first treatment if necessary. Visible signs of control may be seen within several hours after application. Susceptible weeds, moss or algae will turn brown or black. Occasionally a darkening of the grass leaf blades can occur after treatment; however the grass will recover within a few days to weeks. May stain thatch (dead grass under lawn); this does not affect the health of the grass. Use Precautions: Do not apply to drought stressed grass; ensure lawn is well watered prior to application. Do not apply when the daytime temperature will exceed 30oC. Do not apply to bentgrass. If unsure of grass sensitivity, test spray a small area of your lawn. Apply to established turf only. Do not apply to newly seeded areas or to turf generated from seed and that is less than one year old. Avoid spraying desirable

plants. Any desirable plants or structures accidentally contacted should be rinsed with water. To avoid staining, wait until treated area dries before re-entry. Do not apply if rainfall is expected within 3 hours of application. Do not irrigate within 3 hours of application. DO NOT contaminate irrigation or drinking water supplies or aquatic habitats by cleaning of equipment or disposal of wastes. PRECAUTIONS: CAUTION: KEEP OUT OF REACH OF CHILDREN. Causes slight eye irritation. Avoid contact with skin or clothing. Wash hands thoroughly with soap and water after handling and before eating, drinking, and chewing gum or chewing tobacco. DO NOT get in eyes. Avoid hand-to-mouth contact. Avoid breathing spray mist. Do not re-enter or allow re-entry into treated areas until the spray is dried. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. FIRST AID: If swallowed: Call a poison control centre or doctor immediately for treatment advice. Have person sip a glass of water if able to swallow. Do not induce vomiting unless told to do so by a poison control centre or doctor. Do not give anything by mouth to an unconscious person. If on skin or clothing: Take off contaminated clothing. Rinse skin immediately with plenty of water for 15 - 20 minutes. Call a poison control centre or doctor for treatment advice. If inhaled: Move person to fresh air. If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably by mouth-to-mouth, if possible. Call a poison control centre or doctor for further treatment advice. If in eyes: Hold eye open and rinse slowly and gently with water for 15 - 20 minutes. Remove contact lenses, if present, after the first 5 minutes, then continue rinsing eye. Call a poison control centre or doctor for treatment advice. Take container, label or product name and Pest Control Product Registration Number with you when seeking medical attention. TOXICOLOGICAL INFORMATION: Treat symptomatically. STORAGE: Store this product in its original container and keep in a secure storage area out of reach of children and domestic animals. Store unused material, tightly closed, in original container only, away from open flame. Protect from freezing. To prevent contamination store this product away from food or feed. DISPOSAL: Do not reuse empty container. Dispose of empty container with household garbage. Unused or partially used products should be disposed at provincially or municipally designated hazardous waste disposal sites. NOTICE TO USER: This pest control product is to be used only in accordance with the directions on the label. It is an offence under the Pest Control Products Act to use this product in a way

that is inconsistent with the directions on the label. The user assumes the risk to persons or property that arises from any such use of this product.

Pull'N Spray is a registered trademark of OMS Investments, Inc., used under license by Scotts Canada Ltd. SELECTIVE BROADLEAF HERBICIDE Made with iron People and pets can enter treated area when spray dries. No unpleasant odor.

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Ministdre I'Environnement de
sur Comit6consultative les pesticides C.P.2434 2300,rue Yonge, Bureau1701 Toronto ON M4P 1E4 T6l.: 416-314-923519230 T6l6c.: 416-314-9237 www.opac.gov.on.ca

Ministryof Environment the

Pesticides AdvisoryCommittee P.O.Box 2434 2300YongeStreet, Suite1701 Toronto ON M4P 1E4 Tel: 4161314-923519230 Fax: 416-314-9237 www.opac.qov.on.ca

May 5,2010 W. Neudorff GmbH KG Germany Dear Registrant: This letter is to advisethat the following product(s)has been classifiedby the Director underthe PesticidesAct in accordance with Ontario Regulation 63109: Reg# 29535 29539 Class 4 6 Name FiestaLawn Weed Killer NEUlT73II

This product(s)was classifiedon April 30,2010 and effectivethis dateit is legal for sale and usein Ontario. Classifiedproductswill be postedon the Ministry of the Environmentwebsite:h!!p/Www.ene. gov.on.cAle_n/larld/pestic_ide$/-c_14$S_-pestic.ides.php and updatedin the ministry's pesticidedatabase. If you have any questionsconcerningthis decisionpleasecontactthe Ontario Pesticide Advisory Committee (OPAC) office at 416-314-9230. Note that section B of Ontario Regulation 63109 requiresregistrantswhose productsare classified into ClassesI to 7 to notify OPAC of any changes a pesticide'sregistration in or label within 30 days after you were notified of the changeby Health Canada'sPest Management RegulatoryAgency. Yours truly,
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DouglasMewett Executive Secretary

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