# Determination ofNonregulated

Status Under

7 CFR Part

340

for JR Simplot Company

FlO, F37, E12, E24,

J3, JSS, J78, GH, H37,

and HSO Potatoes In response

to petition 13-022-01

p from

JR Simp

lot Company (hereinafter

referred

to

as JR Simplot),

the Animal

and Plant Health Inspection

Service (APHIS)

of the United States Department

of Agriculture

(USDA)

has detennined

that

JR Simplot

FlO, F37, El2, E24,

J3, J55, J78,

G II, H37,

and H50 potatoes (hereinafter

referred

to

as FlO, F37, El2, E24,

J3, J55, J78, Gil, H37,

and H50 potatoes)

and progeny derived

from them

are not likely

to pose

a plant
pest risk and

are

no longer

to be considered regulated

articles
under APHIS's Biotechnology Regulations

(Title

7 of the Code

of Federal Regulations

(CFR),

part 340). Since APHIS

has determined

that

Fl

0, F37, El2, E24,

J3, J55, J78,

Gil, H37,

and H50 potatoes

are unlikely

to pose

a plant
pest risk, APHIS

will approve

the petition

for nomegulated

status ofF!

0, F37, El2, E24,

J3, J55, J78, Gil, H37,

and H50 potatoes. Therefore, APHIS-approved

pennits

or acknowledged notifications

that were previously
required

for environmental

releases, interstate movement,

or importation

under these regulations

will

no longer

be required

for

Fl

0, F37, El2, E24,

J3, J55, J78, Gil, H37,

and H50 potatoes

and their progeny. Importation

ofFIO,

F37, El2, E24,

J3, J55, J78, Gil, H37,

and H50 potato
seeds

and other propagative

material

will still

be subject

to APHIS foreign quarantine

notices

at

7 CFR
part 319. This Determination ofnomegulated

status under

7 CFR
part 340

for FlO, F37, El2, E24,

J3, J55, J78,

G II,
H3

7, and H50 potatoes

is based

on APHIS' analyses

of field

and laboratory

data submitted

by JR Simplot, references provided

in the petition, peer-reviewed publications,

and other relevant information

as described

in the Plant
Pest Risk Assessment

(PPRA)

for FlO, F37, E12, E24,

J3, J55, J78, Gil, H37,

and H50 potatoes. The Plant
Pest Risk Assessment

(PPRA) conducted

on FlO, F37, El2, E24,

J3, J55, J78, Gll, H37,

and H50 potatoes concluded

that they

are unlikely

to pose

a plant
pest risk
and should

no longer

be subject

to the regulations

at

7 CFR
part 340

for the following reasons: (I) No plant
pest risk was identified

from

the transformation

process,

the insertion

and/or expression

of new genetic material,

or from changes

in metabolism

in the

Fl

0, F37, El2, E24,



# B, J55, J78, Gil, H37,

and H50 potatoes. (2) Disease

and pest incidence

and/or damage

were

not observed

to be significantly
increased

or atypical

in the FlO, F37, El2, E24,

J3, J55, J78,

Gil, H37,

and H50 potatoes compared

to the nontransgenic
counterpart

or other comparators

in field trials conducted

in growing regions representative

of where

the FlO, F37, El2, E24,

J3, J55, J78, Gil, H37,

and H50 potatoes

are expected

to be grown

and

in laboratory

studies. Observed agronomic

traits

also did not reveal

any significant differences

that would indirectly
indicate

that

the

Fl

0, F37, El2, E24,

J3, J55, J78,

Gll, H37,

and H50 potatoes

are more susceptible

to pests

or diseases. Therefore

no plant
pest effects

are expected

on these

or other agricultural
products

and

no impacts

are expected

to APHIS

pest control programs. (3) Based

on

an evaluation

of the gene products,

the compositional

similarity

of FlO, F37, El2, E24,

J3, J55, J78, Gil, H37,

and H50 potatoes

to the parent varieties,

and
the observed interactions

ofFlO,

F37, El2, E24,

J3, J55, J78,

Gil, H37,

and H50 potatoes

with insects,exposuretoand/orconsumptionoftheFlO,F37,El2,E24,13,J55, J78,Gil,H37,andHSOpotatoesisunlikelytoadverselyimpactnontargetorganismsbeneficialtoagriculture.(4)TheFlO,F37,El2,E24,J3,J55, J78,Gil,H37,andHSOpotatoesarenomorelikelytobecomeweedierormoredifficulttocontrolasaweedthanconventional varietiesofthiscropbasedontheirobservedagronomiccharacteristics,weedinesspotentialofthecropandcurrentmanagementpracticesavailabletocontroltheFlO,F37,E12,E24,13,J55, J78,GII,H37,andHSOpotatoesasaweed.(5)TheFlO,F37,El2,E24,J3,J55, J78,Gil,H37,andHSOpotatoesarenotlikelytoincreasetheweedriskpotentialofotherspecieswithwhichtheycaninterbreedintheU.S.oritsterritories.Geneflow,hybridizationand/orintrogressionofinsertedgenesfromtheFl0,F37,El2,E24,J3,J55,J78,Gil,H37,andHSOpotatoestoothersexuallycompatiblerelativeswithwhichtheycaninterbreedisnotlikelytooccur.Intheunlikelyeventofsuchintrogression,thesecompatiblerelativesarenotconsideredweedyorinvasive.Thenewphenotype(s)conferredbygeneticengineeringarenotlikelytoincreasetheweedinessofthesecompatiblerelatives.(6)Significantchangestoagriculturalorcultivationpractices(e.g.pesticideapplications,tillage,irrigation,harvesting,etc.)fromadoptionoftheFlO,F37,El2,E24,J3,J55, J78,Gil,H37,andHSOpotatoesarenotexpected.(7)HorizontalgenetransferofthenewgeneticmaterialinsertedintotheGEplanttootherorganismsishighlyunlikely,andisnotexpectedtoleaddirectlyorindirectlytodisease,damage,injuryorharmtoplants,includingthecreationofnewormorevirulentpests,pathogens,orparasiticplants.APHISalsoconcludesinitsPPRAthatnewvarietiesderivedfromFlO,F37,El2,E24,J3,J55,J78,Gil,H37,andHSOpotatoesareunlikelytoexhibitnewpropertiesthataresubstantiallydifferentfromtheonesobservedforFlO,F37,El2,E24,13,J55, J78,Gil,H37,andHSOpotatoes,orthoseobservedinotherpotatoesvarietiesnotconsideredregulatedarticlesunder7CFSpart340,thatwouldposeaplantpestrisk.PriortothisDeterminationofnonregulatedstatus,APHIScompletedanEnvironmentalAssessment(EA)andFindingofNoSignificantImpact(FONSI)forthisaction,andconcludedthataDeterminationofnonregulatedstatusunder7CFRpart340forFlO,F37,El2,E24,13,J55,J78,GII,H37,andHSOpotatoesandtheirprogenywouldhavenosignificantimpacts,individually orcollectively,onthequalityofthehumanenvironmentandwillhavenoeffectonfederallylistedthreatenedandendangeredspecies,speciesproposedforlisting,ortheirdesignatedorproposedcriticalhabitats.APHISalsoconcludeswithitsDetenninationofnonregulatedstatusunder7CFRpart340,baseduponitsPPRA,andinformedbytheEAandFONSI,thatnewvarietiesderivedfromFlO,F37,E12,E24,J3,J55, J78,Gil,H37,andHSOpotatoesareunlikelytoexhibitnewpropertiesthataresubstantiallydifferentfromtheonesobservedforFl0,F37,El2,E24,13,J55, J78,GII,H37,andHSOpotatoes,orthoseobservedforotherpotatovmietiesnotconsideredregulatedarticlesunder7CFRpart340,thatwouldposeaplantpestrisk.Basedonmyfullandcompletereviewandconsiderationofallthescientificandenviromnentaldata,analyses,information,theinputfromthepublicinvolvementprocess,andtheconclusionsofthePPRA,theEA,andthePONSI,andmyknowledgeandexperienceastheDeputyAdministratorofAPHISBioteclmologyRegulatoryServices,IhavedetenninedanddecidedthatthisDeterminationofnon-regulatedstatusforFlO,F37,El2,E24,J3,J55, J78,Gil,H37,andH50potatoesisthemostscientificallysoundandappropriateregulatorydecision.$;<1Zc1AyMichaelJ.Firko,Ph.D.APHISDeputyAdministratorBiotechnologyRegulatoryServicesAnimalandPlantHealthInspectionServiceU.S.DepartmentofAgricultureDate: