DeterminationofNonregulatedStatusforDowAgroSciences'DAS-40278-9CornInresponsetopetition09-233-0lpfromDowAgroSciencesLLC(hereinafterreferredtoasDAS),theAnimalandPlantHealthInspectionService(APHIS)oftheUnitedStatesDepartmentofAgriculture(USDA)hasdeterminedthatagenetically-engineeredDAScornlinewithincreasedtoleranceandresistance,respectively,tophenoxyauxinherbicidesandaryloxyphenoxypropionate(AOPP)acetylcoenzymeAcarboxylase(ACCase)inhibitor("fop")herbicides,hereinafterrefeJTedtoasDAS-40278-9corn,andprogenyderivedfromit,arenotlikelytoposeaplantpestriskandarenolongertobeconsideredregulatedmticlesunderAPHIS'sBioteclmologyRegulations(Title7oftheCodeofFederalRegulations(CFR),part340).SinceAPHIShasdeterminedthatDAS-40278-9cornisunlikelytoposeaplantpestrisk,APHISwillapprovethepetitionfornonregulatedstatusofDAS-40278-9corn.Therefore,APHISapprovedpermitsoracknowledgednotificationsthatwerepreviouslyrequiredforenvironmentalreleases,interstatemovement,orimportationundertheseregulationswillnolongerberequiredforDAS-40278-9comanditsprogeny.ImportationofDAS-40278-9cornseedsandotherpropagativematerialwillstillbesubjecttoAPHISforeignquarantinenoticesat7CFRpmt319andFederalSeedActregulationsat7CFRpart201and7CFR361.ThisDetenninationofnonregulatedstatusforDAS-40278-9cornisbasedonAPHIS'analysesoffieldandlaboratorydatasubmittedbyDAS,referencesprovidedinthepetition,peerreviewedpublications,andotherrelevantinformationasdescribedinthePlantPestRiskAssessment(PPRA)forDAS-40278-9corn.ThePlantPestRiskAssessment(PPRA)conductedonDAS-40278-9comconcludedthatitisunlikelytoposeaplantpestriskandshouldnolongerbesubjecttotheregulationsat7CFRpart340forthefollowingreasons:(I)Noplantpestriskwasidentifiedfromthetransfonnationprocess,theinsertionand/orexpressionofnewgeneticmaterial,orfromchangesinmetabolismintheDAS-40278-9corn.(2)Diseaseandpestincidenceand/ordamagewerenotobservedtobesignificantlyincreasedoratypicalintheDAS-40278-9comandderivedhybridscomparedtotheirnontransgeniccontrolcounterpartsorotl1ercomparatorsinfieldtrialsconductedingrowingregionsrepresentativeofwheretheDAS-40278-9comisexpectedtobegrown.ObservedagronomictraitsalsodidnotrevealanysignificantdifferencesthatwouldindirectlyindicatethattheDAS-40278-9cornismoresusceptibletopestsordiseases.Thereforenoplantpesteffectsareexpectedontheseorotheragriculturalproducts.(3)Basedonanevaluationofthegeneproduct(AAD-1protein)andagronomicandcompositionaldata,exposuretoand/orconsumptionoftheDAS-40278-9cornareunlikelytoadverselyimpactnontargetorganismsbeneficialtoagriculture.

# (4) The DAS-40278-9

com

is no more likely

to become weedier

or more difficult

to control

as

a weed than conventional varieties

of this crop based

on its observed agronomic characteristics,

the weediness potential

of the crop and current management practices available

to control the DAS-40278-9

com

as

a weed. (5) The DAS-40278-9

com

is not likely

to increase

the weed risk potential

of other species
with which

it can interbreed

in the U.S.

or its territories.

Gene flow, hybridization

and/or introgression

of inserted genes fi·om
the DAS-40278-9

com

to other sexually compatible relatives

with which

it can interbreed

is not likely

to occur. (6) Major changes

in agricultural

or cultivation practices associated

with the adoptionofDAS40278-9

com
are not expected

with the exception

of those associated

with
the use

or the timing

of application

of certain phenoxy-auxin herbicides

and ACCase inhibitor
"fop" herbicides.

These changes

are not likely

to increase
plant diseases

or pests

or compromise their management. (7) Horizontal

gene transfer

of the new genetic material inserted

into DAS-40278-9

com

to other organisms

is highly unlikely,

and

is not expected

to lead directly

or indirectly

to disease, damage, injury

or harm

to plants, including

the creation

of new

or more vimlent pests, pathogens,

or parasitic plants. APHIS

also concludes,

based

on the PPRA,

that new varieties derived
from DAS 40278-9

com are unlikely

to exhibit
new properties

that are substantially different

from
the ones observed

for DAS 40278-9
com,

or those observed

in otl1er com varieties

not considered regulated articles under

7 CFS pati 340, tl1at would pose

a plant pest risk. Prior

to this Detennination

of nonregulated

status, APHIS completed

a Final Environmental Impact Statement (FEIS) which explored

the potential environmental

impacts

that

a detennination

of nonregulated

status

for the DAS-40278-9

com and

its progeny would have

on the quality

of the human environment.

The FEIS concluded,
among other things,

that

a determination ofnonregulated

status

for DAS-40278-9

com (and

its progeny)

will have

no effect on federally-listed threatened

and endangered species, species proposed

for listing,

or their designated

or proposed critical habitats. APHIS

also concludes

with

its Determination

of nonregulated

status, based upon

its PPRA,

and informed

by the completion

of the FEIS
and the Record

of Decision

that was issued for the FEIS, that new varieties derived
from DAS-40278-9 com
are unlikely

to exhibit
new properties

that are substantially different

from
the ones observed for DAS-40278-9

com,

or those observed

for other com varieties

not considered regulated articles under

7 CFR part 340, that would pose

a plant pest 1isk. Based

on my full and complete review

and consideration

of all the scientific

and environmental data, analyses,

and inf01mation,

the input from
the public involvement process,

and tl1e conclusions

of the PPRA,

the FEIS
and
its Record

of Decision,

and my knowledge

and expeiience

as the Deputy Administrator

of APHIS Biotechnology Regulatory Services,

I havedeterminedanddecidedthattinsDetenninationofnonregulatedstatusforDAS-40278-9comisti1emostscientificallysoundandappropriateregulatorydecision./'//(Michael.f.Firko,Ph.D.DeputyAdministratorBiotechnologyRegulatmyServicesAnimalandPlantHealti1InspectionServiceU.S.Department,ofAgricultureDate:c?/v·/;.;;,)11)/u//L.I