DeterminationofNonregulatedStatusforDowAgroSciences'DAS-44406-6SoybeanInresponsetopetition11-234-01pfromDowAgroSciencesLLC(hereinafterreferredtoasDAS),theAnimalandPlantHealthInspectionService(APHIS)oftheUnitedStatesDepartmentofAgriculture(USDA)hasdeterminedthatagenetically-engineeredDASsoybeanlinewithincreasedherbicideresistancetoaryloxyalkanoate-based,including2,4-D,pyridyloxyacetate,glufosinateandglyphosateherbicides,hereafterreferredtoasDAS-44406-6soybean,andprogenyderivedfi-omit,arenotlikelytoposeaplantpestriskandarenolongertobeconsideredregulatedarticlesunderAPHIS'sBioteclmologyRegulations(Title7oftl1eCodeofFederalRegulations(CFR),part340).SinceAPHIShasdetetminedthatDAS-44406-6soybeanisunlikelytoposeaplantpestrisk,APHISwillapprovetl1epetitionfornonregulatedstatusofDAS-44406-6soybean.Therefore,APHIS approvedpermitsoraclmowledgednotificationsthatwerepreviouslyrequiredforenvironmentalreleases,interstatemovement,orimportationundertheseregulationswillnolongerberequiredforDAS-44406-6soybeananditsprogeny.ImportationofDAS-44406-6soybeanseedsandotherpropagativematerialwillstillbesubjecttoAPHISforeignquarantinenoticesat7CFRpart319andFederalSeedActregulationsat7CFRpart201and7CFRpart361.ThisDetenninationofnonregulatedstatusforDAS-44406-6soybeanisbasedonAPHIS'analysesoffieldandlaboratorydatasubmittedbyDAS,referencesprovidedinthepetition,peerreviewedpublications,andotherrelevantinformationasdescribedinthePlantPestRiskAssessment(PPRA)forDAS-44406-6soybean.ThePlantPestRiskAssessment(PPRA)conductedonDAS-44406-6soybeanconcludedthatitisunlikelytoposeaplantpestriskandshouldnolongerbesubjecttoregulationsat7CFRpart340forthefollowingreasons:(I)Noplantpestriskwasidentifiedfromthetransfonnationprocess,theinsertionand/orexpressionofnewgeneticmaterial,orfromchangesinmetabolismintheDAS-44406-6soybean.(2)Diseaseandpestincidenceand/ordamagewerenotobservedtobesignificantlyincreasedoratypicalintheDAS-44406-6soybeanandderivedhybridscomparedtotheirnontransgeniccontrolcounterpartsorothercomparatorsinfieldtrialsconductedingrowingregionsrepresentativeofwheretheDAS-44406-6soybeanisexpectedtobegrown.ObservedagronomictraitsalsodidnotrevealanysignificantdifferencesthatwouldindirectlyindicatethattheDAS-44406-6soybeanismoresusceptibletopestsordiseases.Thereforenoplantpesteffectsareexpectedontheseorotheragriculturalproducts.(3)Basedonanevaluationofthegeneproducts(AAD-12,PATand2mEPSPS)andagronomicandcompositionaldata,exposuretoand/orconsumptionoftheDAS-44406-6soybeanareunlikelytoadverselyimpactnontargetorganismsbeneficialtoagriculture.(4)TheDAS-44406-6soybeanisnomorelikelytobecomeweedierormoredifficulttocontrolasaweedthanconventionalvarietiesofthiscropbasedonitsobservedagronomiccharacteristics,theweedinesspotentialofthecropandcuiTentmanagementpracticesavailabletocontroltheDAS-44406-6soybeanasaweed.(5)TheDAS-44406-6soybeanisnotlikelytoincreasetheweedriskpotentialofotherspecieswithwhichitcaninterbreedintheU.S.oritsterritories.Geneflow,hybridizationand/orintrogressionofinsertedgenesfromtheDAS-44406-6soybeantoothersexuallycompatiblerelativeswithwhichitcaninterbreedisnotlikelytooccur.(6)MajorchangesinagriculturalorcultivationpracticesassociatedwiththeadoptionofDAS68416-4soybeanarenotexpectedwiththeexceptionofthoseassociatedwiththeuseofthearyloxyalkanoate-based,including2,4-D,pyridyloxyacetate,glufosinateandglyphosateherbicides.Thesechangesarenotlikelytoincreaseplantdiseasesorpestsorcompromisetheirmanagement.(7)HorizontalgenetransferofthenewgeneticmaterialinsertedintotheDAS-44406-6soybeantootherorganismsishighlyunlikely,andisnotexpectedtoleaddirectlyorindirectlytodisease,damage,injuryorham1toplants,includingthecreationofnewormorevimlentpests,pathogens,orparasiticplants.APHISalsoconcludes,basedonthePPRA,thatnewvarietiesderivedfromDAS44406-6soybeanareunlikelytoexhibitnewprope1iiesthataresubstantiallydifferentfromtheonesobservedforDAS44406-6soybean,orthoseobservedinothersoybeanvarietiesnotconsideredregulatedarticlesunder7C.F.R.Part340,thatwouldposeaplantpestrisk.Priortotl1isDeterminationofnonregulatedstatus,APHIScompletedaFinalEnviromnentalImpactStatement(FEIS)whichexploredthepotentialenvironmentalimpactsthatadetemlinationofnonregulatedstatusfor theDAS-44406-6soybeananditsprogenywouldhaveonthequalityofthehumanenvironment.TheFEISconcluded,amongotherthings,thatadeterminationofnonregulatedstatusforDAS-44406-6soybean(anditsprogeny)willhavenoeffectonfederally-listedthreatenedandendangeredspecies,speciesproposedforlisting,ortheirdesignatedorproposedcriticalhabitats.APHISalsoconcludeswithitsDetenninationofnonregulatedstatus,baseduponitsPPRA,andinfmmedbythecompletionoftheFEISandtheRecordofDecisionthatwasissuedfortheFEIS,thatnewvarietiesderivedfi·omDAS-44406-6soybeanareunlikelytoexhibitnewpropertiesthataresubstantiallydifferentfromtheonesobservedforDAS-44406-6soybean,orthoseobservedforothersoybeanvarietiesnotconsideredregulatedarticlesunder7CFRpart340,thatwouldposeaplantpestrisk.Basedonmyfullandcompletereviewandconsiderationofallthescientificandenvironmentaldata,analyses,andinfonnation,theinputfromthepublicinvolvement process,andtheconclusionsofthePPRA,theFEISanditsRecordofDecision,andmyknowledgeandexperienceastheDeputyAdministratorofAPHISBiotechnologyRegulatoryServices,IhavedeterminedanddecidedthatthisDeterminationofnonregulatedstatusforDAS-44406-6isthe.mostandappropriateregulatorydecision./1/·"J(i.n!DMichaelJ.'irfn,DeputyAdministratorBioteclmologyRegulatoryServicesAnimalandPlantHealthInspectionServiceU.S.DepartmentofAgricultureDate:?)I