DeterminationofNonregulatedStatusforDowAgroSciences'DAS-68416-4SoybeanInresponsetopetition09-349-0lpfromDowAgroSciencesLLC(hereinafterreferredtoasDAS),theAnimalandPlantHealthInspectionService(APHIS)oftheUnitedStatesDepartmentofAgriculture(USDA)hasdeterminedthatagenetically-engineeredDASsoybeanlinewithincreasedherbicideresistancetoaryloxyalkanoate-based,including2,4-D,pyridyloxyacetate,glufosinateherbicides,hereinafterreferredtoasDAS-68416-4soybean,andprogenyderivedfromit,arenotlikelytoposeaplantpestriskandarenolongertobeconsideredregulatedarticlesunderAPHIS'sBiotechnologyRegulations(Title7oftheCodeofFederalRegulations(CFR),part340).SinceAPHIShasdetem1inedthatDAS-68416-4soybeanisunlikelytoposeaplantpestrisk,APHISwillapprovethepetitionfornonregulatedstatusofDAS-68416-4soybean.Therefore,APHISapprovedpennitsoracknow!edgednotificationsthatwerepreviouslyrequiredforenvironmentalreleases,interstatemovement,orimportationundertheseregulationswillnolongerberequiredforDAS-68416-4soybeananditsprogeny.ImportationofDAS-68416-4soybeanseedsandotherpropagativematerialwillstillbesubjecttoAPHISforeignquarantinenoticesat7CFRpart319andFederalSeedActregulationsat7CFRpart201and7CFRpart361.ThisDeterminationofnonregulatedstatusforDAS-68416-4soybeanisbasedonAPHIS'analysesoffieldandlaboratorydatasubmittedbyDAS,referencesprovidedinthepetition,peerreviewedpublications,andotherrelevantinfonnationasdescribedinthePlantPestRiskAssessment(PPRA)forDAS-68416-4soybean.ThePlantPestRiskAssessment(PPRA)conductedonDAS-68416-4soybeanconcludedthatitisunlikelytoposeaplantpestriskandshouldnolongerbesubjecttotheregulationsat7CFRpart340forthefollowingreasons:(!)Noplantpestriskwasidentifiedfromthetransfommtionprocess,theinsertionand/orexpressionofnewgeneticmaterial,orfromchangesinmetabolismintheDAS-68416-4soybean.(2)Diseaseandpestincidenceand/ordamagewerenotobservedtobesignificantlyincreasedoratypicalintheDAS-68416-4soybeanandderivedhybridscomparedtotheirnontransgeniccontrolcounterpartsorothercomparatorsinfieldtrialsconductedingrowingregionsrepresentativeofwheretheDAS-68416-4soybeanisexpectedtobegrown.ObservedagronomictraitsalsodidnotrevealanysignificantdifferencesthatwouldindirectlyindicatethattheDAS-68416-4soybeanismoresusceptibletopestsordiseases.Thereforenoplantpesteffectsareexpectedontheseorotheragriculturalproducts.(3)Basedonanevaluationofthegeneproducts(AAD-12andPAT)andagronomicandcompositionaldata,exposuretoand/orconsumptionoftl1eDAS-68416-4soybeanareunlikelytoadverselyimpactnontargetorganismsbeneficialtoagriculture.

# (4) The DAS-68416-4
soybean

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-68416-4

soybean

as

a weed. (5) The DAS-68416-4

soybean

is not likely

to increase

the weed risk potential

of other species with which

it can interbreed

in the U.S.

or its teiTitories.

Gene flow, hybridization

and/or introgression

of inserted genes from

the DAS-68416-4

soybean

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 adoptionofDAS68416-4 soybean

are not expected

with
the exception

of those associated

with
the use
of the aryloxyalkanoate-based,

including
2,4-D, pyridyl oxyacetate

and glufosinate herbicides. These changes

are not likely

to increase
plant diseases

or pests

or compromise

their management. (7) Horizontal

gene transfer ofthe new genetic material inserted

into the DAS-68416-4

soybean to other organisms

is highly unlikely,

and

is not expected

to lead directly

or indirectly

to disease, damage, injury

or hann

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 68416-4 soybean

are unlikely

to exhibit

new properties

that are substantially different

from

the ones observed

for DAS 68416-4 soybean,

or those observed

in other soybean varieties

not considered regulated articles, under

7 C.F.R.
Pmt 340, that would pose

a plant pest risk. Prior

to this Determination

of nonregulated

status, APHIS completed

a Final Environmental Impact Statement (FEIS) which explored

the potential environmental

impacts

that

a Determination

of nonregulated

status

for the DAS-68416-4

soybean

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-68416-4

soybean

(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 Detennination

of nomegulated

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-68416-4 soybean

are unlikely

to exhibit

new properties

that are substantially different

from

the ones observed

for DAS-68416-4
soybean,

or those observed

for other soybean varieties

not considered regulated articles under

7 CFR pmt 340, that would pose

a plant pest risk. Based

on my full and complete review

and consideration

of all the scientific

and enviromnental data, analyses,

and infmnaation,

the input from

the public involvement
process,

and the conclusions

of the PPRA,

tl1e EIS and

its Record

of Decision,

and my lmowledge

and experience

as the Deputy Administrator

of APHIS Biotechnology Regulatory Services,

I havedetenninedanddecidedthatthisDetenninationofnonregulatedstatusforDAS-68416-4soybeanisthesoundandappropriateregulatorydecision...7/!''/,.·t\'i!{,I.//<-············•·/-"/••.J///vI.../<..//._./"!-._,_..'./.../MichaelJ:Firko,Ph.D.DeputyAdministratorBiotechnologyRegulatoryServicesAnimalandPlantHealthInspectionServiceU.S.DepartmentofAgricultureDate: