DocketNumberEPA-HQ-OPP-2007-0437www.regulations.govFenoxaprop-p-ethylProposedInterimRegistrationReviewDecisionCaseNumber7209June2015Approvedby:,JlRichardP.Keigwin,Jr.DirectorPesticideRe-evaluationDivisionDate:ContentsFenoxaprop-p-ethylProposedInterimDecisionTableofContentsI.INTRODUCTION...................................................................................3II.USEANDUSAGE...................................................................................5III.SCIENTIFICASSESSMENTS....................................................................6A.HumanHealth....................................................................................61.RiskConclusions...........................................................................62.HumanIncidents............................................................................63.Tolerances....................................................................................6B.Ecological.........................................................................................61.RiskConclusions............................................................................?2.EcologicalIncidents.........................................................................93.CharacterizationofEcologicalRisk........................................................9C.BenefitsAssessment............................................................................10D:EndangeredSpeciesAssessment.............................................................10E.EndocrineDisruptorScreeningProgram....................................................11IV.PROPOSEDINTERIMREGISTRATIONREVIEWDECISION...........................12V.NEXTSTEPSANDTIMELINE..................................................................14AppendixA:SummaryofActionsTakenforFenoxaprop-p-ethyl....................................16AppendixB:Fenoxaprop-p-ethylLabelTable...........................................................162I.INTRODUCTIONThisdocumentistheEnvironmentalProtectionAgency's(EPAortheAgency)ProposedInterimRegistrationReviewDecisionforfenoxaprop-p-ethyl(FPE)(case7209,PC129092)andisbeingissuedpursuantto40CFRsections155.56and155.58.AregistrationreviewdecisionistheAgency'sdeterminationwhetherapesticidemeets,ordoesnotmeet,thestandardforregistrationintheFederalInsecticide,Fungicide,andRodenticideAct(FIFRA).TheAgencymayissue,whenitdeterminesittobeappropriate,anInterimRegistrationReviewDecisionbeforecompletingaregistrationreview.Amongotherthings,theInterimRegistrationReviewDecisionmay:1)requirenewriskmitigationmeasures;2)imposeinterimriskmitigationmeasures;3)identifydataorinformationrequiredtocompletethereview;and4)includeschedulesforsubmittingtherequireddata,conductingthenewriskassessmentandcompletingtheregistrationreview.ForfurtherinformationonFPE,additionaldocumentscanbefoundinEPA'spublicdocket(EPA-HQ-OPP-2007-0437)atwww.regulations.gov.FIFRA,asamendedbytheFoodQualityProtectionAct(FQPA)of1996,mandatedthecontinuousreviewofexistingpesticides.AllpesticidesdistributedorsoldintheUnitedStatesgenerallymustberegisteredbytheEPAbasedonscientificdatashowingthattheywillnotcauseunreasonableriskstohumanhealthortotheenvironmentwhenusedasdirectedonproductlabeling.Theregistrationreviewprogramisintendedtomakesurethat,astheabilitytoassessandreduceriskevolvesandaspoliciesandpracticeschange,allregisteredpesticidescontinuetomeetthestatutorystandardofnounreasonableadverseeffects.Changesinscience,publicpolicy,andpesticideusepracticeswilloccurovertime.Throughtheregistrationreviewprogram,theAgencyperiodicallyre-evaluatespesticidestomakesurethatasthesechangesoccur,productsinthemarketplacecancontinuetobeusedsafely.Informationonthisprogramisprovidedaswww.epa.gov/oppsrrdllregistrationreview/.In2006,theAgencyimplementedtheregistrationreviewprogrampursuanttoFIFRAsection3(g)andwillrevieweachregisteredpesticideevery15yearstodeterminewhetheritcontinuestomeettheFIFRAstandardforregistration.FPEisaselectivearyloxyphenoxy-propionateherbicideregisteredforusetocontrolgrassweedsafteremergence.Itiscurrentlyregisteredforagriculturaluseonbarley,cotton,rice,soybeans,andwheat.Itisalsoregisteredfornon-agriculturaluseonconservationreserves,ornamentals,rights-of-way,grassgrownforseed(Washington,OregonandUtahonly),andturf.Thereare16FIFRASection3registrationsandseveralFIFRA24(c)SpecialLocalNeedregistrations.AReregistrationEligibilityDecision(RED}wasnotconductedforFPEbecausethepesticidewasregisteredafter1984and,therefore,wasnotsubjecttoreregistration.Pursuantto40CFRsection155.50,EPAformallyinitiatedregistrationreviewforFPE(case7209).ThefollowingsummaryhighlightssignificanteventsthathaveoccurredduringtheregistrationreviewofFPEandcanbefoundinEPA'spublicdocket,EPA-HQ-OPP-2007-0437,accessedatwww.regulations.gov:•August29,2007-PublicationofFPESummaryDocumentfora90-daypubliccommentperiod.TheSummaryDocumentincludedthePreliminaryWorkPlan(PWP)andwasaccompaniedbythescopingdocumentandproblemformulation.3•February29,2008-FinalWorkPlan(FWP)forFPEwasissued.TheAgencyreceivedcommentsfromtwosourcesduringthe90-daypubliccommentperiodonthePWP.TheFIFRAEndangeredSpeciesTaskForce(FESTF)commentedondatacompensationissues.Bayer,atechnicalregistrant,submittedcommentsonFPEstudyresults,revisionstoFPEregistrations,anddetailsoftheproposedhumanhealthandecologicalriskassessments.•February2,2010-GenericDataCall-In(GDCI)forFPEwasissued.•July1,2014-TheAgencypublishedthePreliminary/DraftEcologicalRiskAssessmentfortheRegistrationReviewofFenoxaprop-p-ethylandtheRegistrationReviewPreliminary/DraftHumanHealthRiskAssessmentforFenoxaprop-p-ethylfora60-daypubliccommentperiod.Commentswerereceivedfromtwosources,BayerCropScience(Bayer)andtheCenterforBiologicalDiversity(CBD).BayerclarifiedhowFPEistypicallyusedinagriculture,correctedtypographicalerrorsinthehumanhealthriskassessment,andprovidedjustificationforusingalternativeendpointsinthenon-targetplantandchronicmammalianassessments.TheAgencylargelyconcurredwithBayer'scommentsandmodifieditsassessmentsaccordingly.TheCenterforBiologicalDiversity(CBD)commentedontheAgency'sobligationsundertheEndangeredSpeciesAct(ESA).•June2015-TheAgencyisnowpublishingtheFenoxaprop-p-ethylProposedInterimRegistrationReviewDecision,indocketnumberEPA-HQ-OPP-2007-0437fora60-daypubliccommentperiod.Inadditiontothisdocument,theAgencyisalsopublishingthefollowingsupportingdocuments:oEFEDResponsetoCommentsontheEnvironmentalFateandEcologicalRiskAssessmentfortheRegistrationReviewofFenoxaprop-p-ethyl.ChuckPeck,ScottGlaberman.November3,2014oFenoxaprop-p-ethyl:ResponsetoRegistrantComments.fromBayerCropScienceontheDraftPreliminaryRiskAssessmentandProposedNewUseonGrassGrownforSeed.ShaluShelat,ChristopherSchlosser,DonaldWilbur.December3,2014oAddendumtotheEcologicalAssessmentforFenoxaprop-p-ethyl.ChuckPeck,ScottGlaberman.June4,2015oFenoxapropandFenoxaprop-ethylUsagelnformationforRiskAssessment.BillChism,JihadAlsadek,MichelleRanville.May8,2015oFenoxapropandFenoxaprop-ethylQualitativeBenefitsAssessment.BillChism,MichelleRanville.June11,2015·CommentsReceivedfromtheCenterforBiologicalDiversityComment:TheCenterforBiologicalDiversity's(CBD)commentsfocusontheEPA'sdutytoconsultwiththeUS.FishandWildlifeServiceandtheNationalMarineFisheriesService(theServices)ontheregistrationreviewofFPEinaccordancewiththeESA.TheCBDcommentsmentionvariousaspectsoftheriskassessmentprocess,includinguseofthebestavailabledatatodevelopthreatenedandendangered{listed)speciesriskassessments,andevaluationofeffects4onlistedspeciesandtheirdesignatedcriticalhabitat.CBDalsoexpressesconcernregardingtherigoroftheAgency'spreliminarydeterminationsregardingtheeffectsofFPEonlistedspeciesandtheirdesignatedcriticalhabitatfortheFPEregistrationreview.Response:EPAhasreviewedthecommentsfromCBDandplanstoaddressmanyoftheconcernsraisedbyCBDaspartoftheimplementationplanforassessingtherisksofpesticidestolistedspeciesbasedontherecommendationsoftheApril2013NationalAcademyofSciences(NAS)report.EPAwilladdressconcernsspecifictoFPEinconnectionwiththedevelopmentofitsfinalregistrationreviewdecisionforthispesticide.SeeEndangeredSpeciesAssessmentonpage10ofthisdocumentformoreinformation.II.USEANDUSAGEFPEisapost-emergenceherbicideregisteredforusetoselectivelycontrolannualandperennialgrassweedsinbarley,cotton,soybeans,rice,andwheat.Non-agriculturalusesitesincluderights-of-way,ornamentals,grassgrownforseed(Washington,OregonandUtahonly),andturf.FPEinhibitsacetylCoAcarboxylaseenzyme(ACCase)(WSSAGroup1)andinterfereswithmeristematictissuedevelopment.Whilemostofthisherbicideisusedinwheatcrops,itisalsoappliedtoarelativelylargepercentageofbarleyandricecropsintheUnitedStates.Between2004and2012,theaverageannualpoundsactiveingredient(a.i.)usedareasfollows:barley(20,000lbsa.i/year),rice(10,000lbsa.i/year),soybeans(20,000lbsa.i/year),andspring/winterwheat(200,000lbsa.i/year).EPA'sanalysisdidnotfindanyevidenceoftheuseofFPEapplicationsonanin-season(samecalendaryear)rotationalcropinthesamestate.ThemajorityofFPEusageovertheyears2009-2013wasthroughgroundapplication.Onlytwocrops,barleyandrice,hadasignificantpercentageoftreatmentthroughaerialapplication.ApproximatelyeightpercentoftotalFPE-treatedacresforbarleyareappliedaerially,andmorethanfiftypercentoftotalFPE-treatedacresforriceareappliedaerially.Theaerialapplicationsforricewereapparentlymadetoaccommodatethelargenumberofacresinvolvedandnotspecificallybecauseofwetfields,sincetheywereappliedpre-floodandonlyasmallnumberofacresweretreatedpost-flood.Thebarleyandwheataerialapplicationsweregenerallyappliedlatepost-emergencesothatthelargefieldscouldbetreatedinashortamountoftimewhentheweedsweremostsensitive.SeeFenoxapropandFenoxaprop-ethylUsageInformationforRiskAssessment,datedMay8,2015,foradditionaldetailonFPEuseandusageinformation.III.SCIENTIFICASSESSMENTSA.HumanHealthAsummaryoftheAgency'shumanhealthriskassessmentispresentedbelow. TheAgencyusedthemostrecentAgencysciencepoliciesandriskassessmentmethodologiestoprepareaquantitativeriskassessmentinsupportoftheregistrationreviewofFPE.ForadetaileddiscussionofthehumanhealthassessmentforFPE,seeFenoxaprop-p-ethylHumanHealthRiskAssessmentdatedMarch20,2014andFenoxaprop-p-ethyl:ResponsetoRegistrantCommentsfromBayerCropScienceontheDraftPreliminaryRiskAssessmentandProposedNewUseon5GrassGrownforSeeddatedDecember3,2014.BothofthesedocumentsareavailableinthepublicdocketEPA-HQ-OPP-2007-0437,whichcanbeaccessedathttp://www.regulations.gov/.1.RiskConclusionsEPAhasnodietaryrisksofconcernforFPEfromexposuretoresiduesineitherfoodordrinkingwater.TheAgencyhasnoriskconcernsforresidentialuseofFPEonturforornamentals.Furthermore,EPAhasnoriskconcernfromaggregateexposuretoFPEfromfood,drinkingwater,andresidential/bystanderexposure.EPAhasnotmadeacommonmechanismoftoxicityfindingastoFPEandanyothersubstanceanditdoesnotappeartoproduceatoxicmetaboliteproducedbyothersubstances.Therefore,EPAhasnotassumedthatFPEhasacommonmechanismoftoxicitywithothersubstancesforthisassessment.ForpesticidehandlersreceivingoccupationalexposuretoFPE,EPAhasnoriskconcernsassociatedwithdermalroutesofexposurewhenhandlersusechemical-resistantgloves,whicharerequiredpersonalprotectiveequipmentonallproductlabels.TheAgencyalsoevaluatedexposureandrisktoagriculturalworkerswhoenterareastreatedwithFPEafterapplication.EPAdeterminedthatpostapplicationexposuresandriskswerenotofconcernonthedayofapplication.2.HumanIncidentsTheAgencycompletedareviewofFPEincidentsintheOPPIncidentDataSystem(IDS)andtheCentersforDiseaseControlandPrevention/NationalInstituteforOccupationalSafetyandHealth(CDC/NIOSH)SentinelEventNotificationSystemforOccupationalRisk-Pesticides(SENSOR)databases.BasedonthelowfrequencyandseverityofincidentcasesreportedforFPEinbothIDSandNIOSHSENSOR-Pesticides,theredoesnotappeartobeaconcernatthistimethatwouldwarrantfurtherinvestigation.TheAgencywillcontinuetomonitortheincidentinformationand,ifaconcernistriggered,additionalanalysiswillbeconducted.3.TolerancesCurrentlytherearetolerancesestablishedforFPEbasedonpreviously-establishedtolerancesforfenoxaprop.CertaintolerancesneedrevisionbasedoncurrentAgencypolicy.Thecommoditydefinitionforsoybeanwillbechangedfrom"soybean"to"soybean,seed"andthetolerancefor"peanuthulls"willberevokedsincethatcommodityisnolongeraregulatedrawagriculturalcommodity.TheAgencyisnotawareofanyinternationalharmonizationissuesrelatedtotheexistingFPEtolerances.B.EcologicalAsummaryoftheAgency'secologicalriskassessmentispresentedbelow.TheAgencyusedthemostupdatedAgencysciencepoliciesandriskassessmentmethodologiestoprepareaquantitativeriskassessmentinsupportoftheregistrationreviewofFPE.ForadetaileddiscussionoftheecologicalassessmentforFPE,seeEnvironmentalFateandEcologicalRiskAssessmentforRegistrationReviewofFenoxaprop-p-ethyldatedApril21,2014,theAddendumtotheEcologicalAssessmentforFenoxaprop-p-ethyldatedJune4,2015,andtheEFED6ResponsetoCommentsontheEnvironmentalFateandEcologicalRiskAssessmentfortheRegistrationReviewofFenoxaprop-p-ethyl,datedNovember3,2014.ThesedocumentsareavailableinthepublicdocketEPA-HQ-OPP-2007-0437,whichcanbeaccessedathttp://www.regulations.gov/.TheAgencyalsocompletedascreening-levellistedspeciesassessmentforFPEandidentifiedpotentialriskstoseveraltaxa(terrestrialandsemi-aquaticmonocotplantsandmammals).TheAgencyiscurrentlyworkingwithitsfederalpartnersandotherstakeholderstoimplementaninterimapproachforassessingpotentialrisktolistedspeciesandtheirdesignatedcriticalhabitats.Oncethescientificmethodsnecessarytocompleteriskassessmentsforlistedspeciesandtheirdesignatedcriticalhabitatsarefinalized,theAgencywillcompleteitsendangeredspeciesassessmentforFPE.Assuch,potentialriskstolistedspecieswillnotbediscussedfurtherinthisdocument.1.RiskConclusionsTerrestrialAssessmentMammals-InthepreliminaryriskassessmentforFPE,theAgencyidentifiedchronicrisksofconcernformammalsforalllabeledusesexceptforgrassgrownforseed.Duringthepubliccommentperiodforthepreliminaryriskassessment,Bayerconimentedthattheassessmentincludedsomeincorrectapplicationratesforsomeuses.EPAverifiedtheinformationprovidedbyBayerandthenrevisedtheriskassessmenttoreflectthecorrectuserates.AsaresultofBayer'sclarificationofseveralapplicationrates,chronicmammalianrisksarenolongerofconcernfortheconservationreserveandthesoybeanuseswhenthreeapplicationsareassumed.However,asnotedintheriskassessmentaddendum,thechronicrisklevelofconcern(LOC)formammalsisstillexceededforseveralusesites(riskquotientsrangefrom0.01to2.36).Birds-Therearenoacuteorchronicrisksofconcerntonon-targetbirdsortoreptilesandterrestrial-phaseamphibiansforwhichbirdsserveassurrogates.Invertebrates-Basedonavailabledataforyoungadultbees,FPEisclassifiedaspracticallynon-toxictonon-targetterrestrialinvertebratesonanacutecontactexposurebasis.Sincetheacutecontacttoxicitystudyforhoneybeeswasnon-definitive(i.e.,theLDsowasgreaterthanthehighestdosetested),riskswerenotassessedforterrestrialinvertebrates.ThereissomeuncertaintyregardingtoxicityofFPEtohoneybeelarvaesincenodataonthisdevelopmentalstagewereavailableatthetimeoftheassessment.WheninitiallyscopingtheregistrationreviewforFPE,EPAdidnotidentifytheneedforanyadditionalstudiestoevaluatepotentialeffectsonpollinators.However,sincetheissuanceoftheJune2014GuidanceforAssessingPesticideRiskstoBeesf11,EPAhasbeguntorequirethesedatawhereapplicable.EPAiscurrentlydeterminingwhetheradditionalpollinatordataareneededforactiveingredientsinregistrationreviewwhosedocketsopenedpriortoJune2014.ForthoseactiveingredientswhereEPAdetermines[IIhttp://www2.epa.gov/sites/production/files/2014-06/documents/pollinatorriskassessmentguidance061914.pdf7thatadditionalpollinatorexposureandeffectsdataarenecessarytohelpmakeafinalregistrationreviewdecision,EPAintendstoissueaDCItoobtainthesedata.Inthenearfuture,EPAwillprovidefurtherinformationandguidanceonthiseffort.ThepollinatorstudiesthatcouldberequiredareincludedinTable1below.TheAgencywillrequiredataitbelievesarenecessarytohelpinformthepollinatorriskassessment.Tbl1Ptf1Pll'tD t R ta eoen1aomaora aeqmremensGuideline#Study850.3020*1Acutecontacttoxicitystudywith adulthoneybees850.3030*1Honeybeetoxicityofresiduesonfoliage850.3040**FieldtestingforpollinatorsNon-Guideline*1Honeybeeadultacuteoraltoxicity(OECD213)Non-Guideline*Honeybeelarvaeacuteoraltoxicity(OECD237)Non-Guideline*HoneybeeadultchronicoraltoxicityNon-Guideline*HoneybeelarvaechronicoraltoxicityNon-Residuesinpollenandnectar/fieldresidueanalysisGuideline**Non-Semi-fieldtestingforpollinators(tunnelorcolonyfeedingGuideline**(OECD75)studies)*Tier1(Laboratory-basedstud1es)**Tier2and3(Semi-fieldandfullfieldcolony-levelstudies)Theneedforahighertiertestforpollinatorswillbedeterminedbaseduponlower-tieredtestsand/orotherlinesofdataandtheneedforarefinedpollinatorriskassessment.I.AcceptabledatahavealreadybeensubmittedforFPEorarewaivedbasedonavailableinformation.Plants-BasedonBayer'scommentsduringthepubliccommentperiodandtheinformationgainedaboutapplicationpracticesinasubsequentmeetingwithFPEregistrants1,theAgencyrevisedseveralaspectsoftheriskassessment,includingterrestrialplantendpoints,riskestimates,andspraydriftcalculations.EPAagreedwithBayerthattheinitialendpointsusedfortheplantassessment(i.e.,root/radiclemeasurements)arenolongerspecifiedincurrentterrestrialplantguidelinesandaresubjecttohighvariability.Whenroot/radicalendpointswereomittedfromtheassessment,plantriskestimatesweregreatlyreduced.Inaddition,fortheinitialmodelingassessment,theAgencyassumedsmallerdropletsizesthanareroutinelyused,asFPElabelsareinconsistentwhenreferringtodropletsize(e.g.,mediumsize,micronrange,ornosizeatall).TheAgencyinitiallyusedtheAmericanSocietyofAgriculturalandBiologicalEngineers(ASABE)veryfineto-finedropletsizestomodelgroundapplicationsandfine-to-mediumsizestomodelaerialapplications.RevisedmodelingincludedASABEmedium-to-coarsedropletsizesforaerialapplications,basedontheregistrants'commitmenttoamendproductlabelingtoincludethisdropletsizerangeacrosslabels.1SeeEPA,Bayer,Syngenta,andNufarmMeetingonFenoxapropRegistrationReview,May5,2015,locatedinthedocket.8Theterrestrialplantassessmentpresentsestimatesofhowfaroffthetreatedfield(i.e.,theeffectsdistance)onemightexpectadverseeffectstooccurtonon-targetplantsfromspraydrift.Theinitialassessmentindicatedeffectsdistancesof>1000feetfornon-targetmonocotyledonousterrestrialplants(monocots)forsomeusepatterns.Therevisedassessmentindicatesa7footeffectsdistanceforgroundapplications(allusesites)anda7-43footeffectsdistanceforaerialapplications(variesbysite)usingamedium-coarsedropletsize.Whiletheaboverevisionstotheterrestrialplantassessmentresultedinasignificantdecreaseinriskestimates,theoverallriskconclusionthatalllabeledusesofFPEposepotentialrisksofconcerntonon-targetmonocotshasnotchanged.AquaticAssessmentRisksofconcerntofishandaquaticinvertebratesarenotexpectedfromthelabeledusesofFPE.Thereissomeuncertaintyassociatedwiththisfindingsincetherearenochronicestuarine/marinefishdataavailablenorbenthicinvertebratesedimenttoxicitydata.However,extrapolatingfromchronicfreshwaterfishdata,riskstoestuarine/marinefisharenotexpected.Inaddition,exposuretobenthicinvertebratesisexpectedtobeordersofmagnitudebelowavailableaquatictoxicityendpointsand,thus,risksofconcernarenotexpected.FPEdegradesrapidlyintheaquaticenvironmentandbenthicinvertebrateswouldlikelybeexposedtoFPEdegradates,whichappeartobelesstoxictosedimentdwellingorganism.Basedontheavailabledata,riskstoaquaticplantsarenotexpectedfromthecurrentlyregisteredusesofFPE.2.EcologicalIncidentsTheAgencyhasreceived113reportsofadversefieldeffectstonon-targetplantsthathavebeenlinkedtotheuseofFPE.Alloftheseincidentsinvolveddamagetograincrops(barley,com,lentil,rice,orwheat).TheAgencyconsideredthecauseandattributiontoFPEtobeuncertainin75casesbecausemorethanoneherbicidewasappliedtothecrop.Intheremaining38cases,theAgencyconsidersFPEtobetheprobablecause.Mostoftheincidentswerereportsofcropdamagethatoccurredfollowingapplicationoftheherbicidedirectlytothecrop,althoughfourincidentsoccurredfromcarryovereffectsofapplicationsmadetoanothercropinapreviousgrowingseason.Noneoftheincidentsinvolveddamagetocropsorotherplantsoutsidethetreatmentsite.ForadetaileddiscussionoftheecologicalincidentsforFPE,seeEnvironmentalFateandEcologicalRiskAssessmentforRegistrationReviewofFenoxaprop-p-ethyldatedApril21,2014.3.CharacterizationofEcological RiskThepreliminaryriskassessmentandriskassessmentaddendumforFPEidentifiedsomerisksthatexceededEPA'sLOCfornon-listedspecies.TheAgencyusestheLOCasanindicatorofpotentialadverseeffectstonon-targetorganisms.LOCexceedancesareonlyonelineofevidenceusedbyEPAtodescribetherisksposedbyapesticidetonon-targetorganisms.ThisriskcharacterizationsectionisanattempttodescribeotherlinesofevidenceforFPE,andputtheLOCexceedancesintoabroadercontext9Mammals-WhiletheLOCisexceededforchronicrisktomammals,EPAdoesnotexpectrisktomammalsbasedonthefollowinglinesofevidence.Chronicriskestimatestomammalswerecalculatedusingdatabridgedfromfenoxaprop-ethyl(FE),whichappearstobemoretoxictomammalsthanFPE(seehumanhealthriskassessment).Inaddition,theendpointusedinthemammalianassessmentisfromarattwo-generationstudywherethenoadverseeffectlevelwasthehighestconcentrationtestedinthestudy,sincenosignificantadverseeffectswereobservedatanyofthelevelstested.Giventheconservativenatureoftheassessmentdescribedherein,theAgencydoesnotexpectchronicriskstomammalsfromtheuseofFPE.·TerrestrialPlants-ThisassessmentindicatesthatalllabeledusesofFPEposepotentialrisksofconcerntonon-targetterrestrialplants(monocots),whichissupportedbyaseriesofincidentsreportedforgraincropstreatedwithFPE.TheAgency'sprincipalconcernisoff-targetspraydriftresultingfromaerialapplications.Toaddressthisconcern,EPAandtheFPEregistrantshaveagreedtovariouslabelchangesdesignedtoreduceoff-targetspraydrift.C.BenefitsAssessmentFPEisregisteredforuseforselectivepost-emergencecontrolofdifficulttocontrolannualandperennialgrassspeciesinbarley,rice,soybeans,andwinterandspringwheat.Approximatelytenpercentofthebarleyandwheatcropistreatedwiththisherbicide,onaverage,indicatingthatFPEisimportantincontrollinggrassweedsinthesecrops.InCalifornia,onbarleyandwheat,FPEispartofanIntegratedPestManagementprogramforthecontrolofseveraldifficulttocontrolgrasses.Asapost-emergencetreatment,thegrowercanavoidmakingprophylacticpreemergenceapplications.Inthesecrops,FPEislessexpensivethanseveraloftheotheravailablealternativeherbicides.FPEisgenerallyappliedearlytolatepostemergencetothecropandweedsusinggroundequipment,withlowbooms.Aerialapplicationsprimarilyoccurinonlytwocropswith8%oftotalacrestreatedforbarleyand53%percentoftotalacrestreatedforrice.ForadditionaldetailonthequalitativebenefitsofFPE,seeFenoxapropandFenoxaprop-ethylQualitativeBenefitsAssessmentdatedJune11,2015.D.EndangeredSpeciesAssessmentConsistentwithEPA'sresponsibilityundertheEndangeredSpeciesAct(ESA),theAgencywillevaluateriskstofederallylistedspeciesfromregisteredusesofpesticidesinaccordancewiththeJointInterimApproachesdevelopedtoimplementtherecommendationsoftheApril2013NationalAcademyofSciences·(NAS)report,AssessingRiskstoEndangeredandThreatenedSpeciesfromPesticides.TheNASreport[IJoutlinesrecommendationsonspecificscientificandtechnicalissuesrelatedtothedevelopmentofpesticideriskassessmentsthatEPAandtheServicesmustconductinconnectionwiththeirobligationsundertheESAandFIFRA.EPAwilladdressconcernsspecifictoFPEinconnectionwiththedevelopmentofitsfinalregistrationreviewdecisionforFPE.[IJhttp://www.nap.edu/catalog.php?recordid=l834410InNovember2013,EPA,theU.S.FishandWildlifeService,NationalMarineFisheriesServices(theServices),andtheU.S.DepartmentofAgriculturereleasedawhitepapercontainingasummaryoftheirjointInterimApproachesforassessingriskstolistedspeciesfrompesticides.TheseInterimApproachesweredevelopedjointlybytheagenciesinresponsetotheNASrecommendations,andreflectacommonapproachtoriskassessmentsharedbytheagenciesasawayofaddressingscientificdifferencesbetweentheEPAandtheServices.DetailsofthejointInterimApproachesarecontainedintheNovember1,2013whitepaper._InterimApproachesforNational-LevelPesticideEndangeredSpeciesActAssessmentsBasedontheRecommendationsoftheNationalAcademyofSciencesApril2013Report.121GiventhattheagenciesarecontinuingtodevelopandworktowardimplementationoftheInterim Approachestoassessthepotentialrisksofpesticidestolistedspeciesandtheirdesignatedcriticalhabitat,theecologicalriskassessmentsupportingthisProposedInterimRegistrationReviewDecisionforFPEdoesnotcontainacompleteESAanalysis,includingeffectsdeterminationsforspecificlistedspeciesordesignatedcriticalhabitat.WhiletheagenciescontinuetodevelopacommonmethodforESAanalysis,thepreliminaryriskassessmentfortheregistrationreviewofFPEdescribesthelevelofESAanalysiscompletedforthisparticularregistrationreviewcase.ThisassessmentwillallowEPAtofocusitsfutureevaluationsonthetypesofspecieswherethepotentialforeffectsexists,oncethescientificmethodsbeingdevelopedbytheagencieshavebeenfullyvetted.Oncetheagencieshavefullydevelopedandimplementedthescientificmethodsnecessarytocompleteriskassessmentsforlistedspeciesandtheirdesignatedcriticalhabitats,thesemethodswillbeappliedtosubsequentanalysesofFPEaspartofcompletingthisregistrationreview.E.EndocrineDisruptorScreeningProgramAsrequiredbyFIFRAandFFDCA,EPAreviewsnumerousstudiestoassesspotentialadverseoutcomesfromexposuretochemicals.Collectively,thesestudiesincludeacute,subchronicandchronictoxicity,includingassessmentsofcarcinogenicity,neurotoxicity,developmental,reproductive,andgeneralorsystemictoxicity.Thesestudiesincludeendpointswhichmaybesusceptibletoendocrineinfluence,includingeffectsonendocrinetargetorganhistopathology,organweights,estruscyclicity,sexualmaturation,fertility,pregnancyrates,reproductiveloss,andsexratiosinoffspring.Forecologicalhazardassessments,EPAevaluatesacutetestsandchronicstudiesthatassessgrowth,developmentalandreproductiveeffectsindifferenttaxonomicgroups.AspartofitsmostrecentregistrationdecisionforFPE,EPAreviewedthesedataandselectedthemostsensitiveendpointsforrelevantriskassessmentscenariosfromtheexistinghazarddatabase.However,asrequiredbyFFDCAsection408(p),FPEissubjecttotheendocrinescreeningpartoftheEndocrineDisrupterScreeningProgram(EDSP).EPAhasdevelopedtheEDSPtodeterminewhethercertainsubstances(includingpesticideactiveandotheringredients)mayhaveaneffectinhumansorwildlifesimilartoaneffectproducedbya"naturallyoccurringestrogen,orothersuchendocrineeffectsastheAdministratormaydesignate."TheEDSPemploysatwo-tieredapproachtomakingthestatutorilyrequireddeterminations.Tier1consistsofabatteryof11screeningassaystoidentifythepotentialofachemicalsubstancetointeractwiththeestrogen,androgen,orthyroid(E,A,orT)hormonal121http://www.epa.gov/espp/2013/nas.html11systems.ChemicalsthatgothroughTier1screeningandarefoundto havethepotentialtointeractwithE,A,orThormonalsystemswillproceedtothenextstageoftheEDSPwhereEPAwilldeterminewhich,ifany,oftheTier2testsarenecessarybasedontheavailabledata.Tier2testingisdesignedtoidentifyanyadverseendocrine-relatedeffectscausedbythesubstance,andestablishadose-responserelationshipbetweenthedoseandtheE,A,orTeffect.UnderFFDCAsection408(p),theAgencymustscreenallpesticidechemicals..BetweenOctober2009andFebruary2010,EPAissuedtestorders/datacall-insforthefirstgroupof67chemicals,whichcontains58pesticideactiveingredientsand9inertingredients.AsecondlistofchemicalsidentifiedforEDSPscreening,whichincludedFPE,waspublishedonJune14,20132andincludessomepesticidesscheduledforRegistrationReviewandchemicalsfoundinwater.Neitheroftheselistsshouldbeconstruedasalistofknownorlikelyendocrinedisrupters.ForfurtherinformationonthestatusoftheEDSP,thepoliciesandprocedures,thelistsofchemicals,futurelists,thetestguidelinesandtheTier1screeningbattery,pleasevisitourwebsite.3Inthisproposedinterimdecision,EPAismakingnohumanhealthorenvironmentalsafetyfindingsassociatedwiththeEDSP screeningofFPE.BeforecompletingthisRegistrationReview,theAgencywillmakeanEDSPFFDCAsection408(p)determination.IV.PROPOSEDINTERIMREGISTRATIONREVIEWDECISIONA.RiskMitigationandRegulatory RationaleSprayDriftReductionAsdiscussedintheecologicalriskassessmentsectionofthisdocument,FPEposesapotentialriskconcernfornon-targetterrestrial(monocot)plantsexposedtooff-sitespraydriftfromaerialapplicationsprimarily.FPElabelsareinconsistentwithregardtodropletsize(oneofthemainfactorsaffectingspraydrift),withsomereferencingmediumdropletsize,micronsize,ornospecificreferencetosize.Inaddition,somelabelsreferencewindspeedrestrictionsormaximumreleaseheightwhileothersdonot.Toaddressspraydriftconcerns,theAgencyandtheFPEregistrantshaveagreedtovariouslabelchangesforFPEregistrations.Theselabel.changesareintendedtoestablishabaselinelevelofprotectionthatisconsistentacrossFPElabels.EPAbelievesthisrevisedlabeling,onceinplace,willreducerisksassociatedwithdriftwithoutasignificantreductioninproductefficacy.Theproposedlabelinglanguage,describedbelow,wouldbeincorporatedonlabelsofproductsusedinagricultural,widearea,orrights-ofwaysettings.·•Selectnozzlesandpressurethatdelivermediumorcoarserspraydropletsasindicatedinnozzlemanufacturer'scatalogsandinaccordancewithASABEStandardS-572.•Applicatorsmaysprayonlywhenwindspeedisbetween3and10mph.•Foraerialapplications,thereleaseheightmustbenohigherthan10feetfromthetopofthecropcanopy,unlessagreaterapplicationheightisrequiredforpilotsafety.2Seehttp://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074forthefinalsecondlistofchemicals.3htto://www.epa.gov/endo/12•Foraerialapplications,thedistanceoftheoutermostnozzlesontheboomshouldnotexceedthree-fourthsofthelengthofthewingspanorrotordiameter.Tofurtherreducedrift,useone-halfofthelengthofthewingspanorrotordiameterattheedgeofafield.Herbicide-ResistanceManagementFPEbelongstoaclassofherbicides(ACCaseinhibitors)thathasthethirdhighestnumberofresistantplantspecies(>40)outofthemostcommonlyusedclassesofherbicides.4Inaddition,themajorityofusageoccursinwheat,whichisthecropwiththehighestnumberofresistantweedspecies(71).TheothercropsonwhichFPEismostcommonlyused(rice,winterwheat,soybeans,andcotton)arealsoamongthetoptencropswiththegreatestnumberofherbicide-resistantspecies.InordertoextendtheusefullifeofFPEandslowthedevelopment/expansionofFPE-resistantweedspecies,FPEregistrantshaveagreedtoincludeherbicide-resistancemanagementlanguageuniformlyacrosstheirlabels.TheAgencyisproposingthatallherbicideproductscontainingFPE(exceptforthoseregisteredsolelyforhomeowneruse)containthefollowingminimumherbicide-resistancemanagementelementsontheirlabels.ThesespecificationsfollowtherecommendationsoftheWeedScienceSocietyofAmerica(WSSA)publication,ReducingtheRisksofHerbicideResistance,BestManagementPracticesandRecommendations5.TheAgencyfirstprovidedguidanceonresistancemanagementlabelinginPesticideRegistration(PR)Notice2001-5,GuidanceforPesticideRegistrantsonResistanceManagementLabeling.•Listingofherbicidemechanismofaction,and/orWSSAherbicidegroupnumber,atthetopofthefirstpageofeachproductlabel;•InstructionstoalternateuseofproductscontainingFPEwithotherherbicideswithdifferentmechanismsofaction;•RecommendationstoscoutforweedsbeforeandafterFPEapplication,toensureproperidentificationofweedsandgrowthstageandtoconfirmproductperformance;and•Instructionstoreportherbicidefailuretolocalextensionspecialists,certifiedcropadvisors,and/orFPEregistrants.EPAbelievesthattheinclusionofherbicide-resistancemanagementlanguageonFPElabelsisimportanttoslowthedevelopmentofresistancetothisherbicidewhilemaintainingflexibilityforgrowers.Weedresistanceisacomplexissueandregistrantsplayanimportantroleinensuringeffectiveresistancemanagement.Educatingallstakeholdersonbestpracticesformanagingherbicideresistanceisimportantandtheproductlabelisacriticalpieceofthiseffort.UseRateClarificationsInresponsetotheNovember8,2012EPA-RegistrantFPEFocusMeeting,BayerandSyngentasubmittedseparatelettersonNovember30,2012committingtoclarifyusepatternsonproductlabels(e.g.,maximumannualrates,retreatmentintervals).Bayerrecentlynotedonecorrectiontotheinformationcontainedinitsletterforapplicationstorice:themaximumseasonalrateof0.142lbsa.i./Aisequivalenttothemaximumannualapplicationrate(i.e.,foragivenyear,priortogrowingriceandafterthericehasbeenharvested,noFPEcanbeappliedtothatfielduntilthe4InternationalSurveyofHerbicideResistantWeeds(http://weedscience.org/)5Norsworthyetal.2012.WeedScience2012.SpecialIssue:31-62.13followingyear).BayerandSyngentaagreedtoimplementtheuserateclarificationsasspecifiedintheircommitmentlettersaftertheAgencycompleteditsassessmentofrisksandissueditsregistrationreviewdecisionforFPE.TheNovember30,2012commitmentletterscanbefoundinEPA'spublicdocketfortheFPEregistrationreview(EPA-HQ-OPP-2007-0437).B.ToleranceAmendmentsAlthoughEPAhasdeterminedthattherearenoadversehumanhealtheffectsfromallusesofFPE,theAgencywillpursuethefollowingchangestothetolerancesforFPE,toreflectcurrentpolicies.EPAwillrevisethefollowingestablishedtolerancesin40CFR§180.430(b)asfollows:•Thecommoditydefinitionfor"soybean"tobechangedto"soybean,seed".•Thetolerancesfor"peanut,hull"willberevokedsincethatcommodityisnolongeraregulatedrawagriculturalcommodity.C.ProposedInterimRegistrationReviewDecisionInaccordancewith40CFRSections155.56and155.58,theAgencyisissuingthisProposedInterimRegistrationReviewDecision.ExceptfortheEDSPandESAcomponentsofthiscase,theAgencyhasmadethefollowingProposedInterimRegistrationReviewDecision:(1)noadditionaldataarerequiredatthistime;and(2)changestotheaffectedregistrationsandtheirlabelingareneededatthistime.Inthisproposedinterimregistrationreviewdecision,EPAismakingnohumanhealthorenvironmentalsafetyfindingsassociatedwiththeEDSPscreeningofFPE,norisitmakingacompleteendangeredspeciesfindingoracompleteassessmentofeffectstopollinators.TheAgency'sfinalregistrationreviewdecisionforFPEwilldependupontheresultsofanESASection7consultationwiththeServices,anEDSPFFDCAsection408(p)determination,andanassessmentofthenon-targetexposuretobees.V.NEXTSTEPSANDTIMELINEA.InterimRegistrationReviewDecisionInaccordancewith40CFRSections155.56and155.58,theAgencyisissuingthisProposedInterimRegistrationReviewDecision,andplacingitintheFPEregistrationreviewdocket(EPA-HQ-OPP-2007-0437)forpubliccommentfor60days.AFederalRegisterNoticewillannouncetheavailabilityofthisProposedInterimRegistrationReviewDecisionforFPEandinitiatea60-daycommentperiod.IftherearenosignificantcommentsoradditionalinformationsubmittedtothedocketduringthecommentperiodthatleadstheAgencytochangeitsproposeddecision,EPAwillissueanInterimRegistrationReviewDecisionforFPE(case7209).14B.ImplementationofMitigationMeasuresOncetheInterimRegistrationReviewDecisionisissuedinfinalform,registrantsaretosubmitamendedlabelsthatincludethelabelchangessummarizedinAppendixBtotheAgencyforapprovalwithin60daysfollowingissuanceoftheInterimRegistrationReviewDecisioninfinalform.AsummaryofthemitigationmeasuresaredescribedinAppendicesAandB.15A:SummaryofActionsTakenforFenoxaprop-p-ethylRegistrationReviewCase#:7209PCCode:129092ChemicalType:herbicideChemicalFamily:AryloxyPhenoxyPropionicAcidMechanismofAction:WSSAGroup1AffectedSourceofRouteofDurationofRisk(s)ofAction(s)CommentPopulation(s)ExposureExposureExp_osureConcernTaken./Terrestrial./Aerial./Foliar./Acute./Acute./RequirePlantsApplicationabsorptiontoxicityspraydrift(monocots)reductionlanguage./ClarifyriceannualmaximumapplicationrateAppendixB:FPELabelTableSummaryofLabelingChangesforFPEDescriptionProposedLabelingLanguageforFPEProductsPlacementonLabelSPRAYDRIFTSprayDriftLanguage•SelectnozzlesandpressurethatdelivermediumorDirectionsforUsecoarserspraydropletsasindicatedinnozzlemanufacturer'scatalogsandinaccordancewithASABEStandardS-572.•Applicatorsmaysprayonlywhenwindspeedisbetween3and10mph.•Foraerialapplications,themaximumreleaseheightmustbenohigherthanI0feetfromthetopofthecrop canopy,unlessagreaterapplicationheightisrequiredforpilotsafety.•Foraerialapplications,thedistanceoftheoutermostnozzlesontheboommustnotexceedthree-fourthsofthelengthofthewingspanorrotordiameter.Tofurtherreducedrift,useone-halfofthelengthofthewingspanorrotordiameterattheedgeofafield.HERBICIDERESISTANCEMANAGEMENT-ProductsLabeledforAgriculturalUseHerbicideMechanismFrontPanel,upperrightofAction"Group1HERBICIDE"quadrant,surroundedbyablack(orsuitablecolor)rectangleWeedResistance•InstructionstoalternateuseofproductscontainingDirectionsforUse,priortoManagementFPEwithotherherbicideswithdifferentdirectionsforspecificcropsmechanismsofaction;undertheheading"WEED•RecommendationstoscoutforweedsbeforeandRESISTANCEafterFPEapplication,toensureproperidentificationMANAGEMENT"ofweedsandgrowthstageandtoconfirmproductperformance;•Instructionstoreportherbicidefailuretolocalextensionspecialists,certifiedcropadvisors,and/orFPEregistrants.16SummaryofLabelingChangesforFPEDescriptionProposedLabelingLanguageforFPEProductsPlacementonLabelDIRECTIONSFORUSEClarifyuseratesas•Forrice,themaximumseasonalrateof0.142lbsDirectionsforUseforSpecificspecifiedinBayer'sa.i./AisequivalenttothemaximumannualCrops2012commitmentletterapplicationrateforagivenfield(withtheexceptionofuseonrice,whichiscorrectedinthistable)andinSyngenta's2012commitmentletter17