# NATIONAL ENVIRONMENTAL

POLICY

ACT DECISION AND 

# FINDING

OF

NO SIGNIFICANT

IMPACT Simp

lot Company hmateTM

Potato

with

Low Acrylamide

Potential

and Reduced

Black

Spot Bruise

Events

El2

and E24 (Russet Burbank);

FlO

and

F37 (Ranger

Russet);

13,155,



# and

178 (Atlantic);

Gll

(G);

H37 and

H50

(H) United

States Department

of Agriculture Animal

and Plant Health Inspection

Service Biotechnology

Regulatory

Services The United

States Department

of Agriculture

(USDA),

Animal

and Plant Healtl1 Inspection Service (APHIS)

has developed

this decision document

to comply

with

the requirements

of the National Environmental

Policy

Act (NEPA)

of1969,

as amended,

the Council

of Environmental Quality's

(CEQ) regulations implementing

NEPA,

and

the USDA APHIS'

NEPA implementing regulations

and procedures.

This NEPA decision document,

a Finding

of No Significant

Impact (FONSI),

sets forth APHIS'

NEP

A decision

and

its rationale. Comments

from

the public involvement

process

were evaluated

and considered

in developing

this NEP

A decision. In accordance

with APHIS procedures implementing

NEPA

(7 CFR

part 372), APHIS

has prepared

an Environmental

Assessment

(EA)

to evaluate

and determine

ifthere

are

any potentially

significant

impacts

to the human environment

from

a detennination

on

the regulated status

of

a petition

request

(APHIS

Number 13-022-01

p) by Simp

lot Company

(hereafter referred

to

as Simp

lot)

for fueir genetically

engineered

ItmateTM

potato

tl1at

has reduced acrylamide

potential

and reduced

black

spot bruising.

The

EA

has been prepared

in order

to specifically

evaluate

the effects

on

the quality

of the human environment

that may result

from approving

the petition

seeking nonregulated

status

for InnateTM

Potato.

The

EA assesses alternatives

to

a detennination ofnonregulated

status oflnnateTM

Potato

and analyzes

the potential environmental

and social effects

that

may result

from

tl1e proposed

action

and

the altematives. 

# Regulatory

Authority "Protecting

American agriculture"

is the basic charge

of APHIS.

APHIS provides leadership

in ensuring

the health

and

care

of plants

and animals.

The agency improves agricultural productivity

and competitiveness,

and contributes

to the national economy

and

the public

health. USDA

asserts

that

all methods

of agricultural

production (conventional,

organic,

or the

use

of

# genetically

engineered

( GE) varieties

can provide

benefits

to the environment,

consumers,

and fann income. Since

1986,

the United

States govemment

has regulated genetically

engineered

(GE) organisms pursuant

to

a regulatory

framework

known

as the Coordinated

Framework

for

the Regulation

of Biotechnology

(Coordinated

Framework)

(51

FR 23302,

57 FR 22984).

The Coordinated Framework,

published

by

the Office

of Science

and Teclmology

Policy, describes

the comprehensive

federal regulatory

policy

for ensuring

the safety

of biotechnology

research

and products

and explains

how federal agencies

will

use existing

Federal

statutes



# in

a manner

to ensure

public

health

and enviromnental

safety

while maintaining

regulatory

flexibility

to avoid impeding

the growth

of the bioteclmology

industry.

The Coordinated

Framework

is based

on several important

guiding principles:

(1) agencies

should

define

those transgenic

organisms subject

to review

to the extent pennitted

by their respective

statutory authorities;

(2) agencies

are required

to focus

on

the characteristics

and risks

of the biotechnology

product,

not

the process

by which

it

is created;

(3) agencies

are mandated

to exercise oversight

of GE organisms

only when there

is evidence

of "unreasonable"

risk. The Coordinated

Framework

explains

the regulatory

roles

and authorities

for

the three major agencies

involved

in regulating

GE organisms:

USDA's

APHIS,

the Food

and Drug Administration

(FDA),

and

the Enviromnental

Protection

Agency

(EPA). APHIS

is responsible

for regulating

GE organisms

and plants

under

the plant

pest provisions

in the Plant Protection

Act of2000,

as amended

(7 USC§§

7701

et seq.)



# to ensure

that

they

do not pose

a plant

pest

risk. The FDA regulates

GE organisms

under

the authority

of the Federal

Food,

Drug,

and Cosmetic Act (FFDCA).

The FDA

is responsible

for ensuring

the safety

and proper labeling

of

allplantderived

foods

and feeds, including

those

that

are genetically

engineered.

To help developers

of food

and

feed derived

from

GE crops comply

with

their obligations

under Federal

food safety laws,

FDA encourages

them

to participate

in

a voluntary consultation

process.

The FDA policy statement conceming

regulation

of products

derived

from

new plant varieties,

including

those genetically

engineered,

was published

in the Federal Register

on May

29, 1992

(57

FR 22984- 23005).

Under

this policy,

FDA

uses

what

is tenned

a consultation

process

to ensure

that human food

and animal

feed safety

issues

or other regulatory

issues

(e.g., labeling)

are resolved

prior

to commercial

distribution

of bioengineered

foods. The EPA regulates plant-incorporated

protectants

under

the Federal Insecticide,

Fungicide,

and Rodenticide

Act (FIFRA).

EPA

also

sets tolerance

limits

for residues

of pesticides

on and



# in food

and animal

feed,

or establishes

an exemption

from

the requirement

for

a tolerance,

under the Federal

Food,

Drug

and Cosmetics

Act (FFDCA)

and regulates

ce1iain biological

control organisms

under

the Toxic Substances

Control

Act (TSCA).

The EPA

is responsible

forregulatingthesale,distribution,anduseofpesticides,includingpesticidesthatareproducedbyanorganismthroughtechniquesofmodembiotechnology.RegulatedOrganismsTheAPHISBiotechnologyRegulatoryServices'(BRS)missionistoprotectAmerica'sagricultureandenvironmentusingadynamicandscience-basedregulatoryframeworkthatallowsforthesafedevelopmentanduseofGEorganisms.APHISregulationsat7CodeofFederalRegulations(CFR)part340,whichwerepromulgatedpursuanttoauthoritygrantedbytheFederalPlantPestAct,andfurtherconsolidatedunderthePlantProtectionAct,asamended(7UnitedStatesCode(U.S.C.)7701-7772),regulatetheintroduction(importation,interstatemovement,orreleaseintotheenvironment)ofcertainGEorganismsandproducts.AGEorganismisnolongersubjecttotheplantpestprovisionsofthePlantProtectionActortotheregulatoryrequirementsof7CFRpart340whenAPHISdeterminesthatitisunlikelytoposeaplantpestrisk.AGEorganismisconsideredaregulatedarticleifthedonororganism,recipientorganism,vector,orvectoragentusedinengineeringtheorganismbelongstooneofthetaxalistedintheregulation(7CFR340.2)andisalsoconsideredaplantpest.AGEorganismisalsoregulatedunderPart340whenAPHISdoesnothaveinfonnationtodetennineiftheGEorganismisunlikelytoposeaplantpestrisk.Apersonmaypetitiontheagencythataparticularregulatedarticleisunlikelytoposeaplantpestrisk,and,therefore,isnolongerregulatedundertheplantpestriskprovisionsofthePlantProtectionActortheregulationsat7CFR340.Thepetitionerisrequiredtoprovideinfonnationunder§340.6(c)(4)relatedtoplantpestriskthattheagencymayusetodeterminewhethertheregulatedarticleisunlikelytopresentagreaterplantpestriskthantheunmodifiedorganism.AGEorganismisnolongersubjecttotheregulatoryrequirementsof7CFRpart340ortheplantpestriskprovisionsofthePlantProtectionActwhenAPHISdeterminesthatitisunlikelytoposeaplantpestrisk.APHIS'ResponsetoPetitionforNonregulatedStatusUndertheauthorityoftheplantpestprovisionsofthePlantProtectionAct(PPA)and7CFRPart340,APHIShasissuedregulationsforthesafedevelopmentanduseofGEorganisms.Asrequiredby7CFR340.6,APHISmustrespondtopetitionerswhorequestadeterminationoftheregulatedstatusofGEorganisms,includingGEplantssuchasIlmateTMpotato.Whenapetitionfornonregulatedstatusissubmitted,APHISmustmakeadetermination,baseduponaPlantPestRiskAssessment(PPRA)processdetennination,whethertheGEorganismofconcemislikelytoposeaplantpestriskasdefinedbythePPA.IfAPHISdete1mines,basedonitsPlantPestRiskAssessment(PPRA)detennination,thattheGEorganismisunlikelytoposeaplantpestrisk,thenthatgeneticallyengineeredorganismisnolongersubjecttotheplantpestprovisionsofthePlantProtectionActand7CFRpart340.Simplothassubmittedapetition(APHISNumber13-022-0Ip)toAPHISseekingadete1minationthattheirgeneticallyengineeredInnateTMPotatoisunlikelytoposeaplantpestriskand,therefore,shouldnolongerbearegulatedarticleunderregulationsat7CFRPart340.InnateTMPotatoSimplotsubmittedapetition(APHISNumber13-022-01p)toAPHISin2013fordeterminationofnonregulatedstatusforInnateTMpotatowithreducedacrylamidepotentialandreducedblackspotbruising.AdeterminationofnomegulatedstatusforInnateTMpotatowouldincludeInnateTMPotato,anyprogenyderivedfromcrossesbetweenInnateTMandconventionalpotatoesorotherGEpotatoeventsthathavebeenderegulatedpursuanttoPart340andthePlantProtectionAct.IfinnateTMpotatoisderegulated,growersandpotatoseedsupplierswouldhaveanothervarietyofpotato.InnateTMpotatoiscurrentlyregulatedunder7CFRpart340.InterstatemovementsandfieldtrialsofinnateTMpotatohavebeenconductedundernotifications(14)acknowledgedbyAPHISfrom2009through2011ineightstates:Florida,Indiana,Idaho,Michigan,Nebraska,NorthDakota,Washington,andWisconsin.DataresultingfromthesefieldtrialsaredescribedinAppendix6ofthepetition(Simplot,2013a).CoordinatedFrameworkReviewFoodandDrugAdministrationInnateTMpotatoiswithinthescopeoftheFDApolicystatementconcerningregulationofproductsderivedfromnewplantvarieties,includingthoseproducedbygeneticengineering.InJune2006,FDApublishedrecommendationsin"GuidanceforIndustry:RecommendationsfortheEarlyFoodSafetyEvaluationofNewNon-PesticidalProteinsProducedbyNewPlantVarietiesIntendedforFoodUse"(US-FDA,2011)forestablishingvoluntaryfoodsafetyevaluationsfornewnon-pesticidalproteinsproducedbynewplantvarietiesintendedtobeusedasfood,includingbioengineeredplants.Earlyfoodsafetyevaluationshelpmakesurethatpotentialfoodsafetyissuesrelatedtoanewproteininanewplantvarietyareaddressedearlyindevelopment.TheseevaluationsarenotintendedasareplacementforabiotechnologyconsultationwithFDA,buttheinfonnationmaybeusedlaterinthebiotechnologyconsultation.OnFebruary12,2013,SimplotsubmittedasafetyandnutritionalassessmentoffoodandfeedderivedfromInnateTMpotatototheFDA(US-FDADocketNumberBNF141).FDAiscurrentlyevaluatingthesubmission.Noquestionshavebeenraisedthusfarpursuantto§408(d)oftheFederalFood,Drug,andCosmeticAct.EnvironmentalProtectionAgencyUnderFIFRA,allpesticides(includingherbicides)soldordistributedintheU.S.mustberegisteredbytheEPA(US-EPA,20lla).Registrationdecisionsarebasedonscientificstudies

# that assess

the chemical's

potential

toxicity

and environmental

impact.

To

be registered,

a pesticide

must be

able

to

be used without

posing unreasonable

risks

to people

or the environment.

All pesticides

registered

prior

to November

I, 1984

must

also

be reregistered

to ensure

that

they meet

the current,

more stringent

standards

and should

have

a reregistration review

every

15 years (US-EPA,

20lla).

Before

a pesticide

can

be used

on

a food

or feed

crop, the EPA

must establish

the tolerance

value,

which

is the maximum

amount

of pesticide

residue that

can remain

on

the crop

or

in foods

or feed processed

from

that

crop (US-EPA,

20llb). The EPA regulates plant-incorporated

protectants

(PIPs)

under

the Federal Insecticide, Fungicide,

and Rodenticide

Act (FIFRA)

and certain biological

control organisms

under

the Toxic Substances

Control

Act (TSCA).

The EPA

is responsible

for regulating

the sale, distribution

and

use

of pesticides,

including

pesticides

that

are produced

by

an organism

through techniques

of modem biotechnology. 

# Scope

of the Environmental

Analysis Although

a determination

of nonregulated

status oflnnateTM

potato

would

allow

for new plantings oflnnateTM

potato anywhere

in the U.S., APHIS primarily

focused

the enviromnental analysis

on those geographic

areas

that currently

support

potato production.

A determination

of nonregulated

status

of InnateTM

potato

is not expected

to increase

potato production,

either

by

its availability

alone

or accompanied

by other factors,

or cause

an increase

in overall

GE potato acreage.

To determine

areas

of potato production,

APHIS

used

data

from

the National **Ag~icultural**



# Statistics

Service (USDA-NASS,

201

0)

to determine

where

potato

is produced

in the U.S. (USDA-NASS,

201

0). Potato

is primarily

produced

in Idaho, Washington,

Wisconsin, North Dakota, Wisconsin,

Colorado, Minnesota,

Michigan,

Maine, Califomia,

and Oregon. These

eleven

states comprised approximately

92.3% percent

of the nation's

potato production

of 437,483,000

CWT

in 2012 (USDA-NASS,

2012a; 2012b). Public Involvement On May

3, 2013, APHIS published

a notice

in the Federal Register

(78FR 25942-25943,

Docket no. APHIS-2012-0067)

announcing

the availability

of the Simplot

petition

for

a 60-day

public review

and comment

period. Cmnrnents

were required

to be received

on

or before

July

2, 2013. All comments

were carefully

analyzed

to identify

new issues, alternatives,

or information.

A total of308 comments

1 

# on

the petition

were received

from individuals

during

the comment period.

One

of the comments

had 41,475 sig11atures

appended

to

it. Many

of the commenters

did not mention

their specific disagreement

with APHIS'

analysis oflnnateTM

potato detailed

in the EA

or PPRA (USDA-APHIS,

2013a);

rather,

they expressed

their general opposition

to 1

• 

# Comment documents

may

be viewed

at:**http://www.regulations.gov/#!docketBrowser;rpp~25;po~O;D~APHIS 2012-0067;dct~PS** geneticallymodifiedorganisms(GMOs)orGEcrops.Nonewissues,altemativesorsubstantivenewinformationwereidentifiedinanyofthecommentsreceivedbyAPHIS.OnMay30,2014,APHISpublishedanoticeintheFederalRegister(78FR31080-31082,Docketno.APHIS-2012-0067)announcingtheavailabilityoftheSimplotInnateTMpotatodraftEA(13-022-0lp)andPPRAfora30-daypublicreviewandcommentperiod.ConunentswererequiredtobesubmittedbeforeJune30,2014.Atotalof60publiccommentswerereceivedsubsequenttothedraftEAandPPRApublication.Thedocketfoldercontainingthecommentscanbelocatedathttp://www.regulations.gov/#!docketBrowser;rpp=25;po=O;dct=SR;D=APHIS-2012-0067ResponsestosubstantivecommentsareincludedasanattachmenttothisFindingofNoSignificantImpact.MajorIssuesAddressedintheEATheissuesconsideredintheEAweredevelopedbasedonAPHIS'detenninationthatthesegeneticallyengineeredpotatoesarenolongersubjecttotheplantpestprovisionsofthePlantProtectionActand7CFRpart340,andforthisparticularEA,thespecificpetitionseekingadeterminationofnonregulatedstatusforInnateTMpotato.IssuesdiscussedintheEAweredevelopedbyconsideringpublicconcemsaswellasissuesraisedinpubliccommentssubmittedforotherenvironmentalassessmentsofgeneticallyengineeredorganisms,concemsraisedinlawsuits,aswellasthoseissuesthathavebeenraisedbyvariousstakeholders.Theseissues,includingthoseregardingtheagriculturalproductionofpotatousingvariousproductionmethods,andtheenvironmentalfood/feedsafetyofgeneticallyengineeredplantswereaddressedtoanalyzethepotentialenvironn1entalimpactsoflnnateTMpotato.ThelistofresourceareasconsideredweredevelopedbyAPHISthroughexperienceinconsideringpublicconcemsandissuesraisedinpubliccommentssubmittedforotherEAsofGEorganisms.Theresourceareasconsideredalsoaddressconcemsraisedinpreviousandunrelatedlawsuits,aswellasissuesthathavebeenraisedbyvariousstakeholdersinthepast.Thefollowingissueswereidentifiedasimportanttothescopeoftheanalysis(40CFR1508.25).Theseresourceareascanbecategorizedasfollows:AgriculturalProductionConsiderations:aAcreageandAreasofPotatoProductioneAgronomic/CroppingPracticesePotatoSeedProductioneOrganicPotatoProductionEnvironmentalConsiderations:eWaterResources

# 0



# Soil c



# Air Quality c 

# Climate

Change 0 

# Animals G 

# Plants 0 

# Gene

Flow e 

# Microorganisms 0 

# Biological

Diversity Human

Health Considerations: e Public

Health e Worker

Safety Livestock

Health Considerations: e Livestock

Health/ Animal

Feed Socioeconomic

Considerations: <> 

# Domestic

Economic Enviromnent " Organic

Farming " Trade Economic Environment Alternatives

that were

fully analyzed 

# The

EA analyzes

the potential environmental

consequences

of

a detennination

of nonregulated status

of InnateTM

potato.

To respond favorably

to

a petition

for nonregulated

status, APHIS must determine

that InnateTM

potato

is unlikely

to pose

a plant

pest

1isk. Based

on

its Plant

Pest Risk Assessment (USDA-APHIS,

2013a),

APHIS

has concluded

that InnateTM

potato

is unlikely to pose

a plant

pest

risk. Therefore,

APHIS

must detennine

that InnateTM

potato

is

no longer subject

to

7 CFR

part

340

or the plant

pest provisions

of the Plant Protection

Act.

Two alternatives

were evaluated

in the EA:

(I)



# no action

and

(2) detennination ofnonregulated

status oflnnateTM

potato.

APHIS

has assessed

the potential

for environmental

impacts

for each alternative

in the Environmental

Consequences

section

of the

EA. No Action: Continuation

as

a Regulated

Article 

# Under

the

No Action Alternative,

APHIS

would

deny

the petition.

InnateTM

potato

and progeny derived

from InnateTM

potato

would continue

to

be regulated

articles

under

the regulated

articles under

the regulations

at

7 CFR

part

340. Pennits

or notifications acknowledged

by APHIS would

still

be required

for introductions

oflnnateTM

potato

and measures

to ensure physical

and reproductive

confinement

would continue

to be implemented.

APHIS

might choose

thisalternativeiftherewereinsufficientevidencetodemonstratethelackofplantpestriskfromtheunconfinedcultivationoflnnateTMpotato.ThisalternativeisnotthepreferredalternativebecauseAPHIShasconcludedthroughaPlantPestRiskAssessmentthatInnateTMpotatoisunlikelytoposeaplantpestrisk(USDA-APHIS,2013a)indicatingthisalternativewouldnotsatisfythepurposeandneedofmakingadeterminationofplantpestriskstatusandrespondingtothepetitionfornonregulatedstatus.PreferredAlternative:DeterminationthatInnateTMPotatoisNoLongeraRegulatedArticleUnderthisalternative,InnateTMpotatoandprogenyderivedfromthemwouldnolongerberegulatedarticlesundertheregulationsat7CFRpart340.InnateTMpotatoisunlikelytoposeaplantpestrisk(USDA-APHIS,2013a).PermitsissuedornotificationsacknowledgedbyAPHISwouldnolongerberequiredforintroductionsofInnateTMpotatoandprogenyderivedfromthisevent.ThePreferredAlternative,i.e.,adetenninationofnonregulatedstatusoflnnateTMpotato,isnotexpectedtoincreasepotatoproduction,eitherbyitsavailabilityaloneorassociatedwithotherfactors,orresultinanincreaseinoverallacreageofGEpotato.PotentialimpactswouldbesimilartotheNoActionAlternative.Thisalternativebestmeetsthepurposeandneedtorespondappropriatelytoapetitionfornonregulatedstatusbasedontherequirementsin7CFRpart340andtheagency'sauthorityundertheplantpestprovisionsofthePlantProtectionAct.BecausetheagencyhasconcludedthatInnateTMpotatoisunlikelytoposeaplantpestrisk,adeterminationofnonregulatedstatusoflnnateTMpotatoisaresponsethatisconsistentwiththeplantpestprovisionsofthePPA,theregulationscodifiedin7CFRpart340,andthebiotechnologyregulatorypoliciesintheCoordinatedFramework.AlternativesConsideredbutRe.jectedfromFurtherConsiderationAPHISassembledalistofalternativesthatmightbeconsideredforInnateTMpotato.Theagencyevaluatedthesealternatives,inlightoftheagency'sauthorityundertheplantpestprovisionsofthePlantProtectionAct,andtheregulationsat7CFRpart340,withrespecttoenvironmentalsafety,efficacy,andpracticalitytoidentifywhichalternativeswouldbefurtherconsideredforInnateTMpotato.Basedonthisevaluation,APHISrejectedseveralalternatives.Thesealternativesarediscussedbrieflybelowalongwiththespecificreasonsforrejectingeach.ProhibitanyInnateTMPotatofromBeingReleasedInresponsetopubliccmmnentsthatstatedapreferencethatnoGEorganismsenterthemarketplace,APHISconsideredprohibitingthereleaseoflnnateTMpotato,includingdenyinganypennitsassociatedwiththefieldtesting.APHISdeterminedthatthisaltemativeisnotappropriategiventhatAPHIShasconcludedthatInnateTMpotatoisunlikelytoposeaplanthealthrisk(USDA-APHIS,2013a).In enacting

the Plant Protection

Act, Congress

found

that [D]ecisions

affecting

imports,

exports,

and interstate movement

of products regulated under

[the Plant Protection

Act]

shall

be based

on sound science

... §402(4). On March

II,

20 II,

in

a Memorandum

for

the Heads

of Executive Departments

and Agencies, the White

House Emerging Technologies

Interagency

Policy Coordination

Committee

developed broad principles,

consistent

with Executive

Order

13563,

to guide

the development

and implementation

policies

for oversight

of emerging technologies

(such

as genetic engineering)

at the agency

level.

In accordance

with

this memorandum,

agencies

should

adhere

to Executive Order

13563,

and, consistent

with

that Executive

Order,

the following

principle,

among

others

to the extent permitted

by law when regulating

emerging teclmologies. "[D]ecisions

should

be based

on the best reasonably

obtainable

scientific,

teclmical,

economic, and other information,

within

the boundaries

of the authorities

and mandate

of each agency" Based

on

the PPRA (USDA-APHIS,

2013a),

and

the scientific

data evaluated

therein,

APHIS concluded

that InnateTM

potato

is unlikely

to pose

a plant

pest

risk. Accordingly,

there

is no basis

in science

for prohibiting

the release oflnnateTM

potato. Approve

the petition

in part The regulations

at

7 CFR 340.6(

d) (3)(i)

state

that APHIS

may "approve

the petition

in whole

or in part."

For example,

a determination ofnonregulated

status

in part

may

be appropriate

ifthere is

a plant

pest

risk associated

with some,

but

not

all lines described

in

a petition.

Because

APHIS has concluded

that IlmateTM

potato

is unlikely

to pose

a plant

pest

risk, (USDA-APHIS,

2013a) there

is no regulatory

basis under

the plant

pest provisions

of the Plant Protection

Act

for considering

approval

of the petition

only

in part. Isolation

Distance

between

InnateTM

Potato

and Non-GE

Potato Production

and Geographical Restrictions Because

APHIS

has concluded

that InnateTM

potato

is unlikely

to pose

a plant

pest

risk (USDAAPHIS,

2013a),

an alternative

based

on requiring

isolation

distances

would

be inconsistent

with the statutory

authority

under

the plant

pest provisions

of the Plant Protection

Act

and regulations in

7 CFR

part

340. In response

to public concerns

of gene movement

between

GE

and non-GE

plants,

APHIS considered

requiring

an isolation

distance separating

InnateTM

potato

from conventional

or specialty

potato production.

APHIS

also considered geographically

restricting

the production

of InnateTM

potato

based

on

the location

of production

of non-GE

potato

in organic production systems

or production

systems forGE-sensitive

markets

in response

to public concerns regarding possible

gene movement

between

GE

and non-GE

plants. However,

as presented

in APHIS' plant

pest

risk assessment

for InnateTM

potato,

there

are

no geographic

differences

associatedwithanyidentifiableplantpestrisksforInnateTMpotato(USDA-APHIS,2013a).ThisalternativewasrejectedandnotanalyzedindetailbecauseAPHIShasconcludedthatlimateTMpotatodoesnotposeaplantpestrisk,andwillnotexhibitagreaterplantpestriskinanygeographicallyrestrictedarea.Therefore,suchanaltemativewouldnotbeconsistentwithAPHIS'statutoryauthorityundertheplantpestprovisionsofthePlantProtectionActandregulationsinPart340andthebioteclmologyregulatorypoliciesembodiedintheCoordinatedFramework.Basedontheforegoing,theimpositionofisolationdistancesorgeographicrestrictionswouldnotmeetAPHIS'purposeandneedtorespondappropriatelytoapetitionfornonregulatedstatusbasedontherequirementsin7CFRpart340andtheagency'sauthorityundertheplantpestprovisionsofthePlantProtectionAct.However,individualsmightchooseontheirowntogeographicallyisolatetheirnon-GEpotatoproductionsystemsfromInnateTMpotatoortouseisolationdistancesandothermanagementpracticestominimizegenemovementbetweenInnateTMpotatoandnon-GEpotatofields.InfonnationtoassistgrowersinmakinginfonnedmanagementdecisionsforInnateTMpotatoisavailablefromtheAssociationofOfficialSeedCertifyingAgencies(AOSCA,2010)).RequirementofTestingforInnateTMPotatoDuringthecommentperiodsforotherpetitionsfornonregulatedstatus,somecommentersrequestedthatUSDArequireandprovidetestingforGEproductsinnon-GEproductionsystems.APHISnotesthattherearenonationally-establishedregulationsinvolvingtesting,ctiteria,orlimitsofGEmaterialinnon-GEsystems.Sucharequirementwouldbeextremelydifficulttoimplementandmaintain.Additionally,becauseInnateTMpotatodoesnotposeaplantpestrisk(USDA-APHIS,2013a),theimpositionofanytypeoftestingrequirementsisinconsistentwiththeplantpestprovisionsofthePlantProtectionAct,theregulationsat7CFRpart340andbiotechnologyregulatorypoliciesembodiedintheCoordinatedFramework.Therefore,imposingsucharequirementforhmateTMpotatowouldnotmeetAPHIS'purposeandneedtorespondappropriatelytothepetitioninaccordancewithitsregulatoryauthorities.EnvironmentalConsequencesofAPHIS'SelectedActionTheEAcontainsafullanalysisofthealtemativestowhichwereferthereaderforspecificdetails.ThefollowingtablebrieflysummarizestheresultsforeachoftheissuesfullyanalyzedintheEnvironmentalConsequencessectionoftheEA.Attribute/MeasureAlternativeA:NoActionAlternativeB:DeterminationofNonregulatedStatusMeetsPurposeandNoYesNeedandOb.iectivesUnlikelytoposeaSatisfiedthroughuseofregulatedfieldtrialsSatisfied-riskassessment(USDA-APHIS,plantpestrisk2013a)Management

# Practices Acreage

and Areas

Total commercial

potato production

has

Total acreage dedicated

to potato

is unlikely of Potato

increased

while

land

area dedicated

to

to change,

but adoption oflnnateTM

potato Production

potato

has decreased.

Based

on potato

may reduce .acreage dedicated

to conventional production

trends

and projections,

potatoes

potatoes. will continue

to

be

a major

crop

in the U.S. for

the foreseeable

future. Agronomic

Agronomic

practices

will remain

the same Unchanged

from

No Action Alternative Practices

as used currently. Pesticide

Use

Pesticides

are currently

used

to control

Unchanged

from

No Action Alternative insects, nematodes,

fungi,

and weeds. Potato

Seed

Potato

seed

is primarily

supplied

by seed Unchanged

from

No Action Alternative Production

potatoes. Organic

Potato

Organic

potato growers

use practices

and Unchanged

from

No Action Alternative Production

standards

for production,

cultivation,

and product handling

and processing

to ensure that their products

are

not pollinated

by

or commingled

with conventional

or GE crops. 

# Environment Land

Use

Current

trends

in the acreage

and areas

of Unchanged

from

No Action Alternative production

are likely

to continue

to

be driven

by market conditions

(i.e., increased demand

for

US potato

and potato products for animal

feed,

etc.)

and federal

policy. Water Resources

The primary

cause

of agricultural

NPS

Unchanged

from

No Action Alternative pollution

is increased sedimentation

from soil erosion,

which

can introduce sediments, fertilizers,

and pesticides

to nearby

lakes and streams. Agronomic

practices

such

as conservation

tillage,

crop nutrient management,

pest management,

and conservation

buffers

help protect

water quality

from agricultural

runoff. Soil

Growers

will adopt management

practices

to Unchanged

from

No Action Alternative address

their specific

needs

in producing potatoes.

Erosion potential

may continue

to increase. Air Quality

Agricultural

activities

such

as burning,

Unchanged

from

No Action Alternative tilling, harvesting,

spraying pesticides,

and fertilizing,

including

the emissions

from farm equipment,

can directly

affect

air quality.

Aerial application

of insecticides may impact air

quality

from

drift, diffusion, and volatilization

of the chemicals,

as well as motor vehicle emissions

from airplanes or helicopters. Climate

Change Agriculture-related

activities

are recognized

Unchanged

from

No Action Alternative as both direct sources

of greenhouse

gases (GHGs)

(e.g., exhaust

from motorized equipment)

and indirect

sources

(e.g., agriculture-related

soil disturbance,

fertilizer production).AnimalsandPlantsAnimalsPotatofieldsmaybehosttomanyanimalAnimalsconsumingInnateTMtubersmaybeandinsectspecies.Manyoftheseanimalsexposedtoincreasedlevelsofglutamine,butaretypicallyconsideredpestsandmaybethisisnotexpectedtobedetrimental.controlledbytheuseofintegratedpestmanagementstrategies.PlantsPotatoesarealaborintensive,highlyIntheunlikelyeventofhybridizationofmanagedcrop.MembersoftheplantInnateTMpotatowithconventionalcommunitythatadverselyaffectpotatoresultingprogenymay containloweredproductionmaybecharacterizedasweeds.polyphenoloxidaselevels.However,thisisWeedcontrolisanimportantaspectofnotexpectedtobedetrimental.Innate"'potatoproduction.Potatogrowersusepotatoisnoweedierthanconventionalproductionpracticestomanageweedsinpotatoes.andaroundpotatofields.GeneMovementSincepotatoisprimarilyvegetativelyInnateTMtraitsarenotexpectedtoincreasepropagated,geneflowbetweencultivarsisweedinessinpotato.low.Volunteerpotatoeswouldcontinuetoneedtobecontrolled,althoughtheirsurvivalislow.SoilAbundanceanddiversityofsoilUnchangedfromNoActionAlternativeMicroorganismsmicroorganismsinandaroundpotatofieldsisexpectedtoremainasitiscurrently.BiologicalDiversityThebiologicaldiversityinpotatofieldsisUnchangedfromNoActionAlternativelowerthaninthesurroundinghabitats.HumanandAnimalHealthRisktoHumanGlycoalkaloidsandpatatinswouldcontinueGlycoalkaloidandpatatinexposurewouldHealthtoposearisktohumanhealth.Inthecasecontinue.Forhumansconsuminghighofhumansconsuminghigh-temperaturetemperaturecookedpotatoes,acrylamidecookedpotatoes,theywouldcontinuetobelevelswouldbereducedapproximately60-exposedtoacrylamide.70%,whichwillbenefithumanhealth.RisktoAnimalGlycoalkaloidswouldcontinuetoposeaUnchangedfromNoActionAlternative.Feedrisktolivestockifpotatostemsandfoliagearefedtothem,whichisnotlikely.SocioeconomicDomesticandMostpotatoproductionisusedforfood.BecauseofitspotentialhumanhealthbenefitsEconomicMarketutilizationwouldlikelycontinueas(loweracrylamide)andpotentialreducedEnvironmentitiscurrently.wastage(lowbruising),InnateTMpotatomaycomprisealargershareofthedomesticpotatomarket,andmayresultinincreasedrevenues.TradeEconomicU.S.potatoesandpotatoproductswillTheforeigntradeimpactsassociatedwithaEnvironmentcontinuetoplayaroleinglobalpotatodeterminationofnonregulatedstatusofproduction,andtheU.S.willcontinuetobeInnateTMpotatoesareanticipatedtobesimilarasupplierintheinternationalmarket.totheNoActionAlternative.However,importofeachspecifictraitrequiresseparateapplicationandapprovalbytheimportingcountry.IftheInnate"'traitsareapprovedbyimportingcountries,itmaymakeupalargerpercentageofpotatoimportmarkets.OtherRegulatoryFDAcompletedconsultations,EPAFDAiscurrentlyreviewingSimplot'sApprovalstoleranceexemptionsandconditionalvoluntaryconsultationsubmissionofpesticideregistrationsgrantedFebruary12,2013.CompliancewithOtherLawsCWA,CAA,EosFullycompliantFullycompliantFindingofNoSignificantImpactTheanalysisintheEAindicatesthattherewillnotbeasignificantimpact,individuallyorcumulatively,onthequalityofthehumanenvironmentasaresultofthisproposedaction.IagreewiththisconclusionandthereforefindthatanEISneednotbeprepared.ThisNEPAdeterminationisbasedonthefollowingcontextandintensityfactors(40CFR1508.27).Context-Thetenn"context"recognizespotentiallyaffectedresources,aswellasthelocationandsettinginwhichtheenvironmentalimpactwouldoccur.Thisactionhaspotentialtoaffectconventionalandorganicpotatoproductionsystems,includingsurroundingenvironmentsandagriculturalworkers;humanfoodandanimalfeedproductionsystems;andforeignanddomesticcommoditymarkets.Inthe2012productionyear,potatowascultivatedintheUnitedStatesonapproximately1.2millionacres,representinga4.5%increaseinpotatoacreagefrom2011(USDA-NASS,2012a).Potatoproductionin2011wasestimatedat$336.37/CWTandvaluedatanestimated$7.90to$23.70/CWT(USDA-NASS,2012a).PotatoacresharvestedintheU.S.havedeclinedoverrecentyears,whiletotalproductionhasincreased.Per-acreyields,whichaveragedapproximately336CWTperacrein2012haveincreasedatleastbyseven-foldsincetheearly1900sandhavedoubledsincetheearly1960s.Potatoisgrowninall48ofthecontinentalU.S.stateswithproductionconcentratedinthestatesofColorado,Idaho,Minnesota,NorthDakota,WashingtonandWisconsinaccountingforapproximately75%ofannualproduction(USDA-NASS,2013).IdahoandWashington,thetwotoppotatoproducingstates,typicallyaccountforslightlymorethanone-thirdofthetotalU.S.crop(USDA-ERS,2011).Inrecentyears,thebulkofpotatoproductionintheU.S.hasshiftedfromtheEastandMidwesttotheNorthwestbecauseoftransportationsystemimprovements,declineinconsumptionoffi·eshpotatoes,changesinweatherpattems,andadvantageouspower,tax,andlaborcosts(Guenther,2010).TheaverageAmericanconsumesabout115lbofpotatoannually,ofwhichabouttwo-thirdsisconsumedasprocessedpotatoproducts(USDA-ERS,2010).Differentpotatovarietieshavebeenselectedforperformanceintl1efreshandprocessedmarkets.Russetvarietiesstorewellandarethesourceofmostfi·eshmarketpotatoesandFrenchfries,whiletheAtlanticvarietydoesnotstorewellandisusedprimarilytoproducepotatochips(Simplot,2013a).AfterChina,India,Russia,andtheUkraine,theUnitedStatesisthefifthlargestpotatoproducingcountry(FAO,2013),withannualproductionoverthelastthreeyearsofbetween

# 404-467

million

cwt, grown

on 1.0-1.1

M acres (USDA-NASS,

2013).

In 2011,

the United

States produced approximately

5%

of the total world supply

of potato

(NPC,

2012) (National

Potato Council,

2013).

Major importers

of U.S. potatoes

are Canada,

Mexico,

Japan,

South Korea,

and China

(NPC,

2012; National

Potato Council,

2013).

In 2010,

the U.S. exported

1.6 billion

lb

of potatoes,

with

a total value of$3.8

billion (USDA-AMRC,

2012). Approximately

62%

of exported

potatoes

are

in the form

of frozen

fries (National

Potato Council,

2013). A detennination ofnonregulated

status oflnnateTM

potato

is not expected

to directly

cause

an increase

in agricultural

acreage

devoted

to potato production.

The availability

of l!mateTM

potato will

not change cultivation

areas

for potato production

in the U.S.

and there

are

no anticipated changes

to the availability

other potato varieties

on the market. 

# Intensity-

Intensity

is

a measure

of the degree

or severity

of

an impact

based

upon

the

ten factors.

The following

factors

were

used

as

a basis

for this decision: 1. 

# Impacts

that

may

be both beneficial

and adverse. Public

health concerns associated

with

the

use ofGE potato,

such

as InnateTM

potato,

and GE potato products

focus primarily

on human

and animal (livestock) consumption

of GE food

and

feed commodities. A determination ofnonregulated

status ofl!mateTM

potato

will have

no significant environmental

impact

in relation

to the availability

of GE, conventional,

and organic potato varieties.

As discussed

in Chapter

4 of the EA,

a determination

of nonregulated status oflnnateTM

potato

is not expected

to directly

cause

an increase

in agricultural acreage

devoted

to potato production,

or tl1ose potato

acres devoted

to GE potato cultivation.

The availability

oflnnateTM

potato

will

not change

the cultivation

areas

for potato production

in the U.S.

and there

are

no anticipated

changes

in the availability

of GE

and non-GE

potato varieties

on

tl1e market.

A determination ofnonregulated

status oflnnateTM

Potato

could

add another

potato variety

to the conventional

potato market

and is not expected

to change

tl1e market demands

for

GE potato

or potato produced

using organic methods. Based

on data provided

by Simplot

for InnateTM

potato (Simplot,

2013a),

APHIS

has concluded

that

the availability

oflnnateTM

potato

would

not alter

the agronomic

practices, locations,

and seed production

and quality characteristics

of conventional

and

GE potato seed production

(Simplot,

2013a).

A determination ofnonregulated

status oflnnateTM potato

will

not require

a change

to seed production

practices,

nor current production practices. 2.



# The degree

to which

the proposed

action

affixts

public

health

or safety.Non-GEpotatovarieties,boththosedevelopedforconventionaluseandforuseinorganicproductionsystems,arenotroutinelyrequiredtobeevaluatedbyanyregulatoryagencyintheU.S.forhumanfoodoranimalfeedsafetypriortoreleaseinthemarket.UndertheFFDCA,itistheresponsibilityoffoodandfeedmanufacturerstoensurethattheproductstheymarketaresafeandlabeledproperly.AsaGEproduct,however,foodandfeedderivedfromInnateTMpotatomustbeincompliancewithallapplicablelegalandregulatoryrequirements.GEorganismsforfoodandfeedmayundergoavoluntaryconsultationprocesswiththeFDApriortoreleaseontothemarket.Althoughavoluntaryprocess,thusfarallapplicantswhohavewishedtocommercializeaGEvarietythatwouldbeincludedinthefoodsupplyhavecompletedaconsultationwiththeFDA.Insuchconsultation,adeveloperwhointendstocommercializeabioengineeredfoodmeetswiththeagencytoidentifyanddiscussrelevantsafety,nutritional,orotherregulatoryissuesregardingthebioengineeredfoodandthensubmitstoFDAasummaryofitsscientificandregulatoryassessmentofthefood.Thisprocessincludes:I)anevaluationoftheaminoacidsequenceintroducedintothefoodcroptoconfirmwhethertheproteinisrelatedto!mowntoxinsandallergens;2)anassessmentoftheprotein'spotentialfordigestion;and3)anevaluationofthehistoryofsafeuseinfood(HammondandJez,2011).FDAevaluatesthesubmissionandrespondstothedeveloperbyletterwithanyconcernsitmayhaveoradditionalinformationitmayrequire.SeveralinternationalagenciesalsoreviewfoodsafetyassociatedwithGE-derivedfooditems,includingtheEuropeanFoodSafetyAgency(EFSA)andtheAustraliaandNewZealandFoodStandardsAgency(ANZFS).SimplotprovidedtheFDAwithinformationontheidentity,function,andcharacterizationofthegenesforInnateTMpotato,includingexpressionofthegeneproducts,onFebruary12,2013.TheFDAiscurrentlyreviewingSimplot'ssubmission.AdetenninationofnonregulatedstatusofhmateTMpotatowouldhavethepotentialtoimprovehumanhealthbecauseofitsloweracrylamide-fonningpotential.Sinceacrylamideisnotcontainedinrawpotato,impactstoanimalhealthwouldnotbeanydifferentthaneffectsiflnnateTMpotatocontinuestoberegulated.OtherthanloweredasparagineandPPO,andincreasedglutamine,hmateTMpotatoiscompositionallysimilartocunentlyavailablepotatoonthemarket.3.Uniquecharacteristicso{thegeographicareasuchasproximitytohistoricorculturalresources,parklands,primefarmlands,wetlands,·wildandscenicrivers,orecological(vcriticalareas.Therearenouniquecharacteristicsofgeographicareassuchasparklands,primefarmlands,wetlands,wildandscenicareas,orecologicallycriticalareasthatwouldadverselyimpactedbyadetenninationofnonregulatedstatusoflnnateTMpotato.Thecommonagriculturalpracticesthatwouldbecarriedoutundertheproposedactionwillnotcausemajorgrounddisturbance;donotcauseanyphysicaldestructionordamagetoproperty,wildlifehabitat,orlandscapes;anddonotinvolvethesale,lease,ortransferofownershipofanyproperty.ThisactionislimitedtoadeterminationofnonregulatedstatusofInnateTMpotato.Theproductwillbedeployedonagriculturallandcurrentlysuitableforproductionofpotato,willreplaceexistingvarieties,andisnotexpectedtoincreasetheacreageofpotatoproduction.Thisactionwouldnotconvertlandtononagriculturaluseandthereforewouldhavenoadverseimpactonprimefannland.Standardagriculturalpracticesforlandpreparation,planting,irrigation,andharvestingofplantswouldbeusedonagriculturallandsplantedtoInnateTMpotatoincludingtheuseofEPAregisteredpesticides.Applicant'sadherencetoEPAlabeluserestrictionsforallpesticideswillmitigatepotentialimpactstothehumanenvironment.IntheeventofadeterminationofnonregulatedstatusofInnateTMpotato,theactionisnotlikelytoaffecthistoricorculturalresources,parklands,primefannlands,wetlands,wildandscenicrivers,orecologicallycriticalareasthatmaybeincloseproximitytopotatoproductionsites.4.ThedegreetowhichtheeffectsonthequalityofthehumanenvironmentarelikelytobehighZJlcontroversial.Theeffectsonthequalityoftl1ehumanenvironmentfromadeterminationofnonregulatedstatusofirmateTMpotatoarenothighlycontroversial.AlthoughthereissomeoppositiontoadetenninationofnonregulatedstatusofInnateTMpotato,thisactionisnothighlycontroversialintenusofsize,natureoreffectonthenaturalorphysicalenvironment.AsdiscussedinChapter4oftheEA, adetenninationofnonregulatedstatusisnotexpectedtodirectlycauseanincreaseinagriculturalacreagedevotedtopotatoproduction.TheavailabilityofinnateTMpotatowillnotchangecultivationareasforpotatoproductionintheU.S.,andtherearenoanticipatedchangestotheavailabilityofpotatovarietiesonthemarket.Adeterminationofnonregulatedstatusofl!mateTMpotatocouldaddanotl1erpotatovarietytothepotatomarketandisnotexpectedtochangethemarketdemandsforpotatoproducedusingorganicmethods.Adete1minationofnonregulatedstatusofinnateTMpotatowillnotresultinchangesinthecun·entpracticesofplanting,tillage,fertilizerapplication/use,cultivation,pesticideapplicationuse/volunteercontrol.Managementpracticesandseedstandardsforproductionofcertifiedpotatoseedwouldnotchange.TheeffectofinnateTMpotatoonwildlifeorbiodiversityisnotdifferentthanthatofcropscunentlyusedinagriculture,orotherpotatoproducedinconventionalagricultureintheU.S.Duringthepubliccommentperiod,APHISreceivedcommentsopposingadeterminationofnonregulatedstatusofInnateTMpotato.Nonewissues,alternativesorsubstantivenewinfonnationwereidentifiedinanyofthecommentsreceivedbyAPHIS.APHIShasaddressedsubstantivecommentsintheresponsetopubliccommentsdocumentattachedtothisFONSIbasedonscientificevidencefoundinpeer-reviewed,scholarly,andscientificjournals.5.Thedegreetowhichthepossibleeffectsonthehumanenvironmentarehighlyuncertainorinvolveuniqueorunlawwnrisks.BasedontheanalysisdocumentedintheEA,thepossibleeffectsonthehumanenvironmentarewellunderstood.Theeffectsoftheproposedactivitiesarenothighlyuncertainanddonotinvolveuniqueorunknownrisksonthenaturalorphysicalenvironment.AsdiscussedinChapter4oftheEA,adeterminationofnonregulatedstatusoflnnateTMpotatoisnotexpectedtodirectlycauseanincreaseinagriculturalacreagedevotedtopotatoproduction.AdeterminationofnonregulatedstatusofInnateTMpotatowillnotresultinchangesinthecurrentpracticesofplanting,tillage,fertilizerapplication/use,andvolunteercontrol.Managementpracticesandseedstandardsforproductionofcertifiedpotatoseedwouldnotchange.TheeffectofInnateTMpotatoonwildlifeorbiodiversityisnodifferentthanthatfromothercropscurrentlyusedinagriculture,orotherpotatoproducedinconventionalagricultureintheU.S.AsdescribedinChapter2oftheEA,wellestablishedmanagementpractices,productioncontrols,andproductionpractices(GE,conventional,andorganic)arecurrentlybeingusedinpotatoproductionsystems(commercialandseedproduction)intheU.S.Therefore,itisreasonabletoassumethatfanners,whoproduceconventionalpotatovarieties,InnateTMpotato,orproducepotatousingorganicmethods,willcontinuetousetl1esereasonable,commonlyacceptedbestmanagementpracticesfortheirchosensystemsandvarietiesduringagriculturalpotatoproduction.6.Thedegreetowhichtheactionmayestablishaprecedentfor.fittureactionswithsignificanteffectsorrepresentsadecisioninprincipleabouta.fittureconsideration.AdeterminationofnonregulatedstatusforInnateTMpotatowouldnotestablishaprecedentforfutureactionswithsignificanteffectsorrepresentadecisioninprincipleaboutafuturedecision.SimilartopastregulatoryrequestsreviewedandapprovedbyAPHIS,adetenninationofnonregulatedstatuswillbebasedonwhetheranorganismisunlikelytoposeaplantpestriskpursuanttotheregulatoryrequirementsof7CFRpart340.EachpetitionthatAPHISreceivesisspecifictoaparticularGEorganismandundergoesthisindependentreviewtodetennineiftheregulatedarticleposesaplantpestrisk.UndertheauthorityoftheplantpestprovisionsofthePlantProtectionActand7CFRpart340,APHIShasissuedregulationsforthesafedevelopmentanduseofGEorganisms.Asrequiredby7CFR340.6,APHISmustrespondtopetitionerswhorequestadeterminationoftheregulatedstatusofGEorganisms,includingGEplantssuchasInnateTMpotato.Whenapetitionfornonregulatedstatusissubmitted,APHISmustmakeadetenninationiftheGEorganismisunlikelytoposeaplantpestrisk.IfAPHISdeterminesbasedonitsPlantPestRiskAssessmentthatthegeneticallyengineeredorganismisunlikelytoposeaplantpestrisk,thegeneticallyengineeredorganismisnolongersubjecttotheplantpestprovisionsofthePlantProtectionActand7CFRpart340.APHISregulationsat7CFRpart340,whichwerepromulgatedpursuanttoauthoritygrantedbythePlantProtectionAct,asamended(7UnitedStatesCode(U.S.C.)7701-7772),regulatetheintroduction(importation,interstatemovement,orreleaseintotheenvironment)ofcertainGEorganismsandproducts.AGEorganismisnolongersubjecttotheplantpestprovisionsofthePlantProtectionActortotheregulatoryrequirementsof7CFRpart340whenAPHISdeterminesthatitisunlikelytoposeaplantpestrisk.AGEorganismisconsideredaregulatedarticleifthedonororganism,recipientorganism,vector,orvectoragentusedinengineeringtheorganismbelongstooneofthetaxalistedintheregulation(7CFR340.2)andisalsoconsideredaplantpest.AGEorganismisalsoregulatedunderPart340whenAPHIShasreasontobelievethattheGEorganismmaybeaplantpestorAPHISdoesnothaveenoughinfonnationtodetermineiftheGEorganismisunlikelytoposeaplantpestrisk.Apersonmaypetitiontheagencythataparticularregulatedarticleisunlikelytoposeaplantpestrisk,and,therefore,isnolongerregulatedundertheplantpestprovisionsofthePlantProtectionActortheregulationsat7CFRpart340.Thepetitionerisrequiredtoprovideinfonnationunder§340.6(c)(4)relatedtoplantpestriskthattheagencymayusetodeterminewhethertheregulatedarticleisunlikelytopresentagreaterplantpestriskthantheumnodifiedorganism.AGEorganismisnolongersubjecttotheregulatoryrequirementsof7CFRpart340ortheplantpestprovisionsofthePlantProtectionActwhenAPHISdetenninesthatitisunlikelytoposeaplantpestrisk.7.Ff/hethertheactionisrelatedtootheractionswithindividualZvinsignificantbutcumulativeZvsignificantimpacts.Nosignificantadversecumulativeeffectswereidentifiedthroughthisenvironmentalassessment.HumanhealtheffectsofconsumingcookedInnateTMpotatoareexpectedtobepositive.AcumulativeeffectsanalysisisprovidedinChapter5oftheEA.IntheeventAPHISreachesadetenninationofnonregulatedstatusoflnnateTMpotato,APHISwouldnolongerhaveregulatoryauthorityoverthispotato.IntheeventofadetenninationofnonregulatedstatusofinnateTMpotato,APHIShasnotidentifiedanysignificantimpactontheenvironmentwhichmayresultfromtheincrementalimpactofadeterminationofnonregulatedstatusoflnnateTMpotatowhenaddedtopast,present,andreasonablyforeseeablefutureactions.8.Thedegreetowhichtheactionmayadverselyaffectdistricts,sites.highways,structures.orobjectslistedinoreligibleforlistingintheNationalRegisterofHistoricPlacesormaycauselossordestructionofsignificantscientific,cultural,orhistoricresources.AdetenninationofnonregulatedstatusofinnateTMpotatowillnotadverselyimpactculturalresourcesontribalproperties.Anyfanningactivitiesthatmaybetakenbyfannersontriballandsareonlyconductedatthetribe'srequest;thus,thetribeshavecontroloveranypotentialconflictwithculturalresourcesontribalproperties.Adetenninationofnonregulatedstah1soflnnateTMpotatowouldhavenoimpactondistricts,sites,highways,structures,orobjectslistedinoreligibleforlistingintheNationalRegisterofHistoricPlaces,norwouldtheylikelycauseanylossordestructionofsignificantscientific,cultural,orhistoricresources.ThisactionislimitedtoadeterminationofnonregulatedstatusoflnnateTMpotato.Standardagriculturalpracticesforlandpreparation,planting,irrigation,andharvestingofplantswouldbeusedontheseagriculturallandsincludingtheuseofEPAregisteredpesticides.Applicant'sadherencetoEPAlabeluserestrictionsforallpesticideswillmitigateimpactstothehumanenvironment.AdeterminationofnonregulatedstatusofInnateTMpotatoisnotanundertakingthatmaydirectlyorindirectlycausealterationinthecharacteroruseofhistoricpropertiesprotectedundertl1eNationalHistoricPreservationAct.Ingeneral,commonagriculturalactivitiesconductedundertl1isactiondonothavethepotentialtointroducevisual,atmospheric,oraudibleelementstoareasinwhichtheyareusedthatcouldresultineffectsontheuseandenjoymentofahistoricpropertywhencommonagriculturalactivitiesconductedundertl1isactiondonothavethepotentialtointroducevisual,atmospheric,oraudibleelementstoareasinwhichtheyareusedthatcouldresultsineffectsonthecharacteroruseofhistoricproperties.Forexample,tl1ereispotentialforaudibleeffectsontheuseandenjoymentofahistoricpropertywhencmmnonagriculturalpractices,suchastheoperationoftractorsandothermechanicalequipment,areconductedclosetosuchsites.Abuilt-inmitigatingfactorforthisissueistl1atvirtuallyallofthemethodsinvolvedwouldonlyhavetemporaryeffectsontheaudiblenatureofasiteandcanbeendedatanytimetorestoretheaudiblequalitiesofsuchsitestotheiroriginalconditionwithnofurtheradverseeffects.Additionally,thesecultivationpracticesarealreadybeingconductedthroughoutthepotatoproductionregions.ThecultivationoflimateTMpotatodoesnotinherentlychangeanyoftl1eseagronomicpracticessoastogiverisetoanimpactundertheNHPA.9.ThedegreetowhichtheactionmayadverselyaffecttheendangeredorthreatenedspeciesoritshabitatthathasbeendeterminedtobecriticalundertheEndangeredSpeciesActofl973.AsdescribedinChapter4oftheEA,APHIShasanalyzedthepotentialforeffectsfromadeterminationofnonregulatedstatusoflnnateTMpotatoonfederallylistedthreatenedandendangeredspecies(TES)andspeciesproposedforlisting,aswellasdesignatedcriticalhabitatandhabitatproposedfordesignation,asrequiredunderSection7oftheEndangeredSpeciesAct.AfterreviewingpossibleeffectsofadetenninationofnonregulatedstatusoflnnateTMpotato,APHIShasdeterminedthatadetenninationofnonregulatedstatusoflnnateTMpotatowouldhavenoeffectonFederallylistedTESandspeciesproposedforlisting,orondesignatedcriticalhabitatorhabitatproposedfordesignation.I0.WhethertheactionthreatensaviolationofFederal,State,orlocallaworrequirementsimposedfortheprotectionoftheenvironment.

# The proposed

action

would

be

in compliance

with

all federal,

state,

and local

laws. Because

the agency

has concluded

that I1mateTM

potato

is unlikely

to pose

a plant

pest 1isk,

a determination ofnonregulated

status oflnnateTM

potato

is

a response

that

is consistent

with

the plant

pest provisions

of the

PP

A,

the regulations

codified

in

7 CFR part

340,

and

the bioteclmology

regulatory

policies

in the Coordinated

Framework. There

are

no other Federal,

state,

or local permits

that

are needed

prior

to the implementation

of this action. NEPA 

# Decision

and Rationale I have carefully

reviewed

the

EA prepared

for this NEP

A detennination

and

the input

from

the public involvement

process.

I believe

that

the issues identified

in the

EA

are best addressed

by selecting Altemative

2 (Determination

that ImmteTM

potato

is No Longer

a Regulated

Article). This altemative

meets APHIS'

purpose

and need

to allow

the safe development

and

use

of genetically

engineered

organisms

consistent

with

the plant

pest provisions

of the Plant Protection Act. As stated

in the CEQ regulations,

"the agency's

prefened altemative

is the altemative

which

the agency believes

would

fulfill

its statutmy

mission

and responsibilities,

giving consideration

to economic, environmental,

teclmical

and other factors."

The prefened altemative

has been selected

for implementation

based

on consideration

of

a number

of enviromnental,

regulatory, and social factors.

Based

upon

our evaluation

and analysis, Altemative

2

is selected

because

(I) it allows

APHIS

to fulfill

its statutory

mission

to protect America's

agriculture

and environment using

a science-based

regulatory framework

that allows

for

the safe development

and

use

of genetically

engineered

organisms;

and

(2)

it allows APHIS

to fulfill

its regulatory obligations. As APHIS

has

not identified

any plant

pest risks associated

with Im1ateTM

potato,

the continued regulated

status oflm1ateTM

potato

would

be inconsistent

with

the plant

pest provisions

of the PP

A, the regulations

codified

at

7 CFR

part

340,

and

the biotechnology

regulatory

policies

in the Coordinated

Framework.

For

the reasons

stated

above,

I have determined

that

a determination

of nonregulated

status

of InnateTM

potato

will

not have

any significant enviromnental

effects. Michael

J. Firko,

Ph.D. APHIS

Deputy Administrator Biotechnology

Regulatory

Services Animal

and Plant Health Inspection

Service U.S. Department

of Agriculture

Date

# Response

to 

# Public Comments

on Simplot InnateTM

Potato On May

3, 2013, APHIS published

a notice

in the Federal Register

(78

FR 25942-25943,

Docket no. APHIS-2012-0067)

announcing

the availability

of the Simp

lot InnateTM

potato petition

(13- 022-01

p)

for

a 60-day

public

review

and comment

period. Comments

were required

to

be received

on

or before

July

2, 2013.

The docket

folder containing

the comments

can

be located

2 

# at http://www .regulations.gov/#! docketBrowser;rpp=25

;po=O:dct=PS

;D=AP

HIS- 2012-0067- 0001. APHIS received

a total

of 308 submissions

to the docket

from various individuals

and groups

on the Simp

lot potato petition.

Eighty-

five public comments

supported

a detennination

of nonregulated

status oflnnateTM

potato, including submissions

from universities,

growers,

trade associations,

growers' associations,

and private individuals.

Conunents

supporting

the detennination

of nonregulated

status included

the following

areas: e 

# Innate

TM potato

will

be healthier,

safer,

and more nutritious

for consumers. e 

# Because

of

its reduced

black

spot bruising potential,

InnateTM

potato

will reduce

potato wastage,

and therefore,

increase efficiency

for

the potato industry. e Using

native

potato

genes

for genetic engineering

greatly reduces ecological

and evolutionary

risks. e InnateTM

potato

is

a better quality

potato,

with improved

texture

and taste. c InnateTM

potato production

can reduce

use

of fertilizers

and pesticides. e InnateTM

potato

can reduce

potato production

costs. e 

# Gene silencing teclmology

is safe. e InnateTM technology

will

help accelerate

potato development

and improvement,

including disease resistance. e Innate

TM teclmology

represents

a significant improvement

over conventional

breeding teclmiques,

especially

when

those techniques

fail

to eliminate

negative

traits. e InnateTM

potato

can

be safely

stored

and shipped

separate

from conventional

potatoes. e InnateTM

potato

will enhance

global

food security. e InnateTM

potato

has

no potential

for weediness

and clonal propagation

is

an effective barrier

to gene

flow

in potato. e There

is

no evidence

that

GE crops

are unsafe,

even

after

years

of use. The docket received

223 public comments

opposing

a detennination

of nonregulated

status

of l!mateTM

potato.

These comments

included submissions

from private individuals,

and from

two nongovenm1ental

organizations

(NGOs).

One

of the comments

was

a letter

with 41,745 signatures.

The majority

of the comments

broadly

opposed

the development

ofGE

crops

and

the domestic regulatory

process smTounding

GE plants,

as well

as perceived

negative

effects

on public

and animal

health, biodiversity,

and

the environment;

and

the public

right

to choose

non- 'Hyperlink

cannot

be directly

opened.

The hyperlink

must

be pasted

in web browser

address

bar

to

be functional.GEcontainingfoodproducts.Commentsopposingthedeterminationofnonregulatedstatusincluded:•Moreresearchisneededbeforethepetitionshouldbeapproved.•ReductionofasparaginesynthetaseinInnateTMpotatocouldhaveunintendedeffectbecauseasparagineisneededfornitrogentransportandstorageinplants.ePPOsynthetasemayplayaroleinresistancetopathogensandpests,andreductionoftheenzymemayresultinunintendedeffectsonplantfitness.eRNAiteclmologymayhaveunintendedresults.•ThereispotentialforhybridizationofInnateTMpotatowith wildpotatospecies,aswellaspotentialcontaminationofconventionalpotatoeswithInnateTMpotato.OnMay30,2014,APHISpublishedanoticeintheFederalRegister(78FR31080-31082,Docketno.APHIS-2012-0067)mmouncingtheavailabilityoftheSimplotInnateTMpotatodraftEA(13-022-0lp)anddraftPPRAfora30-daypublicreviewandcommentperiod.CommentswererequiredtobereceivedonorbeforeJune30,2014.Thedocketfoldercontainingthecommentscm1belocatedathttp://www.regulations.gov/#!docketBrowser;rpp=25;po=O;dct=SR;D=APHIS-2012-0067Atotalof60publiccommentswerereceivedsubsequenttothedraftEApublication.Themajorityofthosepubliccommentssupportedthedetenninationofnonregulatedstatus;however,somepubliccommentsdidnotsupportthedeterminationofnonregulatedstatus.Supportingcommentersincludedindividualsfrom7differentuniversities,threetradeassociations,oneindustryorganization,andI0farmers.Commentssupportingthedeterminationofnonregulatedstatusincludedthefollowingnew1ssues:1 1TMId..d.nnatepotatomayeatoanmcreasemexportepotatoes.2.Innate1upotato·willbemarketedtoothercountriesthroughandexcellenceinstewardshipprogram.3.Itisinconsistenttoapprovesomegeneticallymodifiedcropssuchascornandsoybean,andnotpotato.4.APHIShasexperiencereviewingcropsgenetica!ZvmodifiedthroughRNAsilencing.Acommenterfromauniversitystatedthat"APHIShasover20yearsofexperienceconductingriskassessmentsonGEplm1tsmodifiedtoexhibitadesiredtraitthatreliesuponanRNAimechanism.TheriskassessmentparametersandmethodologiesAPHISusedtoevaluatetheseearlierproductsareentirelyappropriatefortheInnateTMpotatoes."OfthepubliccommentswhichopposednonregulationofirmateTMpotato,themajorityofthesepubliccommentsdidnotexplainoridentifyelementsintheInnateTMpotatoPPRAorEAthatwereperceivedtobeinadequateorprovideanysupportingevidencefortheirclaims.Threeofthedissentingcommentsdidnotcontainaletter,butonlyattachedpublicationsandarticles.Afourthdissentingcommentcontainedalettertowhich35,451signaturesofcitizenswereappended.APHIScarefullyreviewedthearticlessentinbycommenters.ManyofthemwereincludedintheEA,manyofthempertainedtootherdockets,butnonecontributedanynewinfonnationrelevanttoIm1ateTMpotato.IssuesrelatedtotheIllilateTMpotatoEAwereorganizedintocategoriesandaddressedbelow.Issue1:Fourcommentersaskedfora90-daypubliccommentextension.TheystatedthattherewasinsufficienttimetoadequatelyreviewtheEA.giventhatgrowersarecurrentlybusymanagingcrops.APHISResponse:APHISdeemedthe30-daycommentperiodsufficientopportunityforthepublictoprovidemeaningfulconm1entsonthisEA.Followingthecommetperiod,theAgencythoroughlyreviewedthecommentsandcarefullyconsideredotherinputsasitpreparedAPHIS'EA,FONSI,andregulatorydeterminationinresponsetothispetitionfornonregulatedstatusofinnateTMpotato.Issue2:Acommenterfi·omanNGOstatedthatifInnateTMpotatohasreducedaclylamide,thismayactual(vencouragemoreconsumerdemand.for.fi-iedpotatoproducts,withtheoveralleffectofnotohumanhealth.APHISResponse:APHISdisagreeswiththiscomment.Simplot'scompositionaltestinghaveshownthatacrylamideisreduced,onaverage,58-72%inInnateTMpotato,comparedwithconventionalpotato(NTP,2011;Simplot,2013a).Potatochipsandfriedpotatoproductsrepresentonlyabout1/3ofahuman'sdietaryexposuretoacrylamide(Chawlaetal.,2012).Section2.4.1oftheEA,HumanHealth,describesseveralotherexposureroutesofhumanstoacrylamide,includingbread,biscuits,gingerbread,coffee,andsmoking(Friedman,2003;Chawlaetal.,2012;Kotsioueta!.,2013).AsnotedinSection4.6.1oftheEA,HumanHealth,concernsoveracrylamidesafetymayleadtoprocessorpreferenceforSimplotInnateTMpotatoinFrenchfriesandotherfrozenpotatoproducts.TherearenodatasuggestingthatconsumerpreferencesforfriedpotatoproductswillincreaseifadeterminationofnonregulationisreachedforInnateTMpotato.Issue3:AnEISisneeded.AcommentbyanNGOstatedthatAPHIS'NEPAanalysisisinadequatebecauseitdoesnottakea"hardlookattheenvironmentalconsequences"oftheproposedaction.ThecommentstatedthattheEAdoesnotensure"comprehensive,timely,andtransparentenviromnentalreviewofagencyaction."

# APHIS 

# Response: APHIS disagrees

with

the comment

that

it failed

to take

a hard

look

at the environmental consequences

of the proposed

action

to possibly deregulate

the genetically

engineered

IlmateTM potato.

APHIS believes

that

the

EA

is the comprehensive

and appropriate environmental

review document

for

this proposed

action. Moreover,

APHIS

is confident

that

the

EA

has sound

and reliable environmental

and scientific

analysis.

APHIS carefully considered

and analyzed

the possible environmental

impacts

of the proposed

action,

and

is satisfied

that

the

EA developed

for the proposed deregulation

of the InnateTM

potato

is adequate

and sufficient. Additionally, APHIS'

analysis

and decision

in the PPRA regarding

the potential,

if any, plant

pest

tisk posed by

the InnateTM

potato

is based

on

the best available

scientific

and technical information.

APHIS used sound science

to infonn

its regulatory

decision regarding

the plant

pest

risk

of the InnateTM potato,

and

has concluded

that

the InnateTM

potato

is unlikely

to pose

a plant

pest

risk. APHIS carefully

reviewed

the infonnation

provided

by

the petitioner

and others

and considered

all other relevant information

sufficient

to make

the determination

on the regulated

status oflnnateTM potato. In the EA, APHIS

has made

sure

to consider

and evaluate opposing

and/or contrary

views;

it has reviewed

data submitted

by those

who supported

or opposed

the detennination

of nonregulated status,

and

has made

sure

to use objective,

reliable environmental

and scientific infonnation.

APHIS

has included

an analysis

of each

of the alternatives

and evaluated

and used the best available infonnation

from various

sources, including peer-reviewed

scientific

literature that

was reviewed

and incorporated

into APHIS'

analysis.

APHIS

relied

on

a variety

of trustworthy

sources

to support

its analysis

of the potential

impacts

of

a detennination

of nonregulated

status

for ItmateTM

potato.

These sources

include,

but

are

not limited

to the Simplot petition,

technical

reports,

and peer-reviewed

literature. The

EA

has been prepared

in order

to specifically

evaluate

the potential

effects

on

the quality

of the human environment

that may result

from

a detennination

of nonregulated

status oflnnate

TM Potato.

APHIS assembled

a list

of alternatives

that might

be considered

for detennining

whether or not

the InnateTM

Potato

should

be given non-regulated

status.

The agency evaluated

these altematives,

in light

of the agency's

statutory

authority

under

the plant

pest provisions

of the Plant Protection

Act,

and

the regulations

at

7 CFR

part

340,

with respect

to environmental

safety, efficacy,

and practicality

to identify

which altematives

would

be the appropriate

ones

to consider in reference

to making

a decision

on whether

to deregulate

the hmaten

1 

# potato.

As described

in the EA, APHIS evaluated

two altematives;

(I)



# no action

and

(2) detennination

of nonregulated status

of InnateTM

potato.

In addition,

APHIS rejected

several

other altematives.

These altematives

are discussed

briefly

in Chapter

3 of the

EA along

with

the specific

reasons

for rejecting

each. APHIS

has prepared

the

EA

to specifically

evaluate

the potential

effects

on

the quality

of the human environment

that

may result

from

the deregulation

of InnateTM

potato.

The environmental

analysis

in the

EA

has

not indicated

that

any significant

impacts

on

the enviromnent

would

result

from

the deregulation

and therefore,

APHIS

does

not need

to prepare an EIS

for

this proposed

action.Issue4:APHISneedstoprovidemoreopportunityforpublicparticipation.AcommentfromanNGOstatedthatAPHISdidnotmakean"adequateefforttoengagepublicparticipationinitsreviewofthispetitionforthederegulationofGEpotatoes."ThecommenternotedthatmostAmericansdonotchecktheFederalRegisterforregulatoryactions,andwouldbebetterservedbyAPHISholding"openhouses"asafonuofpublicoutreach.APHISResponse:APHISdisagreeswiththecomment.TheSimplotpetition(13-022-0lp)fordete1minationofnonregulatedstatusandPPRAwerepublishedintheFederalRegisteronMay3,2013(78FR25942-25943,Docketno.APHIS-2012-0067),andtheEAwaspublishedintheFederalRegisteronMay30,2014(78FR31080-31082,Docketno.APHIS-2012-0067)mmouncingtheavailabilityoftheSimplotInnateTMpotatodraftEA.APHISroutinelyseekspublicparticipationthrutheFederalRegisterastheofficialmethodofnotifyingthepublicofregulatoryactions.The60daynoticeofthepetitionandPPRAandthe30daycommentperiodforthisEAallowedforaJUp!epublicparticipation.Thisprovenmethodrenderedover300commentsincludingaletterwithover41,000signatures.Issue5:APHISneedstoprovideavalidpurposeandneedforapprovingGEpotatoes.AcommentfromanNGOstatedthatAPHISneedstodefinethepurposeoftheaction,andAPHIS'statementintheEAthatit"mustrespondtopetitionersthatrequestadeterminationoftheregulatedstatusofGEorganisms"isnotsufficient:"thepurposeandneedofaproposedactionisnotjusttheagencyisconsideringtheaction;rather,thepmposeandneedstatementmustactuallydescribetheunderlyingpurposeandneedfortheproposedaction".ThecommenterassertsthatAPHISneedsto"identifyapurposeand/orneedforapprovingderegulationoftheGEpotatoes",and"describewhyeitherfacilitatingmoreconsumptionofpotatoesorreducingvisiblesignsofdamage(i.e.,browning)isacompellingenoughproblem."APHISResponse:AsmentionedinSection1.1oftheEA, apersonmaypetitiontheagencyforadeterminationthataparticularregulatedarticleisunlikelytoposeaplantpestrisk,andtherefore,isnolongerregulatedundertheplantpestprovisionsofthePPAortheregulationsat7CFR340.Under§340.6(c)(4),thepetitionermustprovideinfonuationrelatedtoplantpestriskthattheagencycm1usetodetenuinewhethertheregulatedarticleisunlikelytopresentagreaterplantpestriskthantheunmodifiedorganism.APHISmustrespondtopetitionersthatrequestadetenuinationoftheregulatedstatusofGEorganisms(7CFR340.6),includingGEplantssuchasSimplotInnateTMpotato.Whenapetitionfornonregulatedstatusissubmitted,APHISmustdetenuineiftheGEorganismisunlikelytoposeaplantpestrisk.APHISdoesnothavetheregulatoryauthoritytoevaluatetheefficacyofapetitioner'sproduct,northeneedfortheproduct.

# Issue

6: APHIS

does

not consider

a "reasonable

range

of alternatives"

in

its EA.



# A comment from

an NGO

that

the alternatives

considered

in the

EA

are

too limited

in scope,

and

that "NEPA requires

APHIS

to consider

and evaluate

a wide range

of alternatives

capable

of addressing

the same problem,"

which

"might

meet

the goals

of the agency

by using different approaches

which may reduce

the environmental

impacts

of the agency's

action."

The commenter

suggested

that APHIS

include consideration

of alternative

ways

to stop browning

in potatoes

such

as selectively breeding

non-GE

potato varieties

with lower susceptibility

to browning

or with lower acrylamide potential.

The commenter

refers

to

a guidance document

from

FDA which suggests

that conventional

breeding

has "shown promise"

in reducing acrylan1ide

potential.

The commenter lists several

other alternatives

such

as assessing

sugar

levels

in potatoes

coming

into processors, managing

storage conditions

to control sprouting,

and handling

potatoes

gently

during harvest, transport,

and delivery. APHIS Response: APHIS disagrees

with

this comment.

The commenter

suggested alternatives

that

are

not within the range

of alternatives

that reasonably

needed

to

be considered.

Those suggested alternatives are neither economical

nor practical.

Therefore,

APHIS

did

not evaluate

these alternatives because

they

are outside

the scope ofthis

EA.

The analysis presented

for each

of the alternatives within

this

EA provides

the agency decisiomnaker

and

the public

with

as full

a picture

as practicable

of the effects

of

it determination.

The agency believes

the analysis

of these alternatives

in this

EA provides

the decisiomnaker

and public

with

the impacts

of each

of these alternatives

and differences

in environmental

impacts

that would

result.

Even

so,

in the end,

the analysis contained

in tllis

EA does

not expand

the agency's

authority

or impose

a duty

to select what

some

view

as the most enviromnentally

friendly

result.

This decision

does

not prevent potato processors

from choosing

the method

to prevent browning

that

they

wish

to employ.

The EA

has been prepared

in order

to specifically

evaluate

the potential

effects

on

the quality

of the hnman enviromnent

tl1at

may result

from

a determination

of nonregulated

status

of Im1ate

TM 

# potato. As discussed

in Section

2.1

of the EA, Agricultural

Production

and Agronomic

Practices

of Potato,

Potato Breeding,

potato breeding

by conventional

methods

is very difficult

andtimeconsuming

and may

talce years

to successfully

introduce

as single

trait. InnateTM

potato

uses

a single construct

to transfonn

5 different commercial

parent varieties

and create

I 0 events (USDA-APHIS,

2013a).

The objective oflnnateTM

potato

was

to incorporate

the same

new phenotypes

into

each

of these important

varieties,

while maintaining

all

of the desirable characteristics

originally

selected

by potato breeders.

If

a single variety

was transfonned,

it would

take decades

to move

tl1ese

new traits

into

the other commercial

varieties

by conventional breeding,

and even

then,

it would

be difficult

to reconstitute

tl1e desirable characteristics

of the original

variety.

# The

EA referenced

FDA's guidance document

(FDA,

2013)

in

its EA,

in Section

2.4.1, Human Health.

FDA specifically

notes

that

the recommendations

contained

in the document

are

for guidance

only,

and

do not represent endorsement

by FDA.

The guidance

report

also

lists benefits

and drawbacks

for available

methods

to reduce acrylamide,

noting

that some

of these methods

are more efficacious

than others,

and

that some

may affect product

qualities

such

as flavor

and texture. Issue

7: APHIS

did

not ''properly"

consider cumulative

impacts.



# A comment

from

an NGO stated

that

the cumulative

impacts

section

in the

EA

did

not have enough quantitative

data

or detailed infonnation,

and

was

too general.

In particular,

the commenter

asserted

that APHIS "does

not account

for

the

fact

that Simp

lot

has stated

its intention

to cross

these potatoes

with other varieties,

and

to introduce

other

GE potatoes."

The commenter

further

stated

that APHIS did

not consider

the potential

for hanns introduced

by the deregulation

of Innate

TM potato

to adversely

affect nontarget

organisms

such

as pollinators

and

on

the potato market.

In particular, the commenter

states

that APHIS

should consider cumulative

impacts

on "consumer preferences."

The commenter

states

that APHIS

needs

to consider socioeconomic

impacts

and the cumulative

effects

of "possible

increased

pesticide

use

as

a result

of the

GE potatoes,"

as well

as the "pathogen-resistance

effects

of Simplot's

genetic engineering."

The commenter concluded

that

an EIS

is needed

for these reasons. APHIS Response: APHIS disagrees

with

the commenter.

Section

5.1

of the

EA, Assumptions

Used

for Cumulative Impacts Analysis,

discusses

this issue.

The cumulative

effects analysis

is focused

on

the incremental

impacts

of the Preferred Alternative

taken

in consideration

with related activities including

past, present

and reasonably

foreseeable

future actions.

In this analysis,

if there

are

no direct

or indirect

impacts identified

by

a resource

area,

then APHIS assumes

there

can

be

no cumulative

impacts. With regard

to the commenter's

concern

that APHIS

did

not evaluate

the cumulative

effects

of Simplot's

stated objective

of crossing

Innate

TM 

# potato

with

other potato varieties,

because APHIS

has determined

that InnateTM

potato

is not

a plant

pest

risk (USDA-APHIS,

2013a),

by definition,

any progeny

resulting

from crosses between InnateTMand

conventional

potato varieties

will

not

be

a plant

pest

risk. Simplot ItmateTM

potato

is agronomically

and compositionally

similar

to other potato cultivars (USDA-APHIS,

2013a). The commenter

misstates

our regulatory

process.

If Simp

lot introduces

other

GE potatoes,

those potatoes

will have

to undergo

the same regulatory

process

as Innate

TM potato.

In other words,

a new Simplot

GE potato

would

be evaluated

under

7 CFR

part

340. The commenter recommends

that APHIS consider

the cumulative

impacts oflnnate

TM potato

on consumer preferences.

There

are

no data available

to suggest

that determination

of nonregulated status

will

alter consumer preferences.ThecommenteralsosuggeststhatAPHISshouldconsiderthepotentialforincreaseduseofpesticideswiththederegulationoflimateTMpotato.AsspecificallystatedinSection5.2,PastandPresentReasonablyForeseeableActions,Simplot'smulti-yearfieldtrialdatashowednoincreaseinpesticideuseforInnateTMperfonnanceversusthatofconventionalpotatocontrols.Ninecomments,includingthosefromrepresentativesofthreeuniversitiesandanagribusiness,submittedafterthepublicationofthepetition,statedthatlimateTMpotatoproductionmaydecreasepesticideuse.EPAregulatestheuseofpesticidesunderFIFRA.EPAsetstheconditionsforpesticideuseonthelabeltoachieveastandardofa"reasonablecertaintyofnoharm."Therefore,theimpactofpesticideuseisoutsidethescopeofthisEA.The"pathogen-resistanceeffects"oflnnateTMpotatowasalsoraisedbythecommenterasapotentialcumulativeeffectnotevaluatedbyAPHIS.ThisissueiscoveredintheAPHISResponsetoIssueII,below.Issue8:APHISdidnot"adequately"considersocioeconomicimpacts.ThecommenterstatedthatAPHISmustconsider"pastcontaminationepisodesfromGEcrops"initsanalysis.ThecommenterfurtherstatedthatcontaminationofconventionalpotatoeswithInnateTMpotatocouldadverselyaffectforeignmarkets.ThecommenterconcludedthatAPHISmustprepareanEIStoanalyzethepotentialforcontaminationpriortoderegulation.APHISResponse:APHIShasconsideredthepastcontaminationepisodesfromGEcrops.SpecificallyforGEpotato,itisdifficulttocommingleacropofitssize.Furthermore,potatoisasexuallypropagatedsoitdoesn'thavecrosspollinationsissueslikeothercrops.Thereforeitisrelativelyeasytoidentitypreservepotato.APHISdiscussedsocioeconomicimpactsinSection4.7oftheEA,SocioeconomicImpacts.BecauseofthereducedblackspotbruisepotentialofSimplotlimateTMpotato,itisexpectedthatwastagewilldecreasesignificantly,andtherefore,revenueswillincrease.Overall,ifAPHISchoosesthePreferredAlternative,theintroductionofSimplotlimateTMeventsarelikelytohavepositiveeconomicimpacts.Potatoeswithlowacrylamideandreducedblackspotbruisepotentialareexpectedtohavehighermarketvalueforthesameinputs,representingpotentialincreasedrevenueforgrowersandprocessors,andanoverallincreaseinthevalueofpotatoproduction.Issue9:APHISdidnotadequatelyconsidertransboundwyimpacts.AcommentfromanNGOstatedthatAPHISdidnotconsidertheeffectofadeterminationofnonregulatedstatusofItmateTMpotatoonothernations.TheconunenterspecificallycitedCanadabecause"muchoftheU.S.potatoindustryisinnorthernstates."Thecommenteralsostatedthatrelyingonvoluntarygroweragreements,isolationdistancesandprocessorrequirementsisnotsufficient.APHISResponse:

# Global sensitivities

to GE products,

including international

restrictions

on import

ofGE products and inability

of the petitioner

to gain approval

for cultivation

or importation,

will continue

to affect trade

with those countries.

These challenges

to international

trade

in GE products

are already

in place. Restrictions

on international

trade

in GE products,

including

Innate

TM 

# potato, are unlikely

to change

with

a detennination

of nonregulated

status

of Im1ate



# TM potato. Issue

10: Data

on the.fimction

of PPO

and pathogen susceptibility

is inadequate

to make

a determination ofnonregulated

status.



# A comment

from

an NGO disagreed

with Simplot's

data conclusions

with regard

to susceptibility

to pathogens.

The commenter

stated

that Simp

lot should

have performed

pathogen

challenge

tests

on

its potatoes

to address

this issue.

The commenter

also noted

that

if gene silencing

is incomplete

in leaves,

an intennediate

phenotype which

is more susceptible

to pathogens

might

occur.

The commenter

stated

that

if disease susceptibility

is increased,

this could

lead

to increased

use

of pesticides

to control

the diseases. APHIS Response: The literature

contains

large numbers

of publications

discussing

the metabolic

pathway

ofPPO (polyphenol

oxidase),

including

nine which

have

been referenced

in this

EA (Felton

eta!.,



# 1989; Steffens,

1994; Martinez

and Whitaker,

1995; Friedman,

1997; Yoruk

and Marshall,

2003; Mayer,

2006; Stremmel

eta!.,



# 201

0; Tran eta!.,



# 2012; Navarre

et al., 

# 2013).

The metabolic pathway

has, therefore,

been

well studied.

APHIS'

response

to the above comment

describes research conducted

to date

on function

ofPPO. As discussed

in the PPRA (USDA-APHIS,

2013a)

and

in Section

4.5.1 ofthe

EA, Animal Communities,

the biological

function

ofPPO

in plants

has

not been conclusively

detennined (Mayer,

2006), although

there

are suggestive

data

that

the oxidation

products

ofPPO

appear

to play

a role

in general

plant defense mechanisms

against pathogens

and pests. Phenolics

can inhibit

the growth

of specific pathogens

and

can

also inhibit enzymes

involved

in pathogenesis (Lyon,

1989). Researchers

have studied

the effect

of phenols

on disease resistance

(e.g., (Lyon, 1989; Kroner

and Mamet,

2012)

but have

no proof

that phenols

are impmtant

mediators

of interactions

between

potato

and disease organisms. The issue

of the relationship

between

PPO

and resistance

to herbivores

was discussed

in the PPRA (USDA-APHIS,

2013a). Although

trichomes

in some plants produce defensive compounds

involving

PPO

in response

to insect

attack,

the trichomes

of cultivated

potatoes contain

low amounts

of PPO which

is not thought

to

be involved resistance

to pests (Friedman, 1997). With regard

to the comment

that Simplot

should

have perfonned

assays challenging

hmate



# TM potato

with pathogens,

Simplot

did

this (Simplot,

2013a).

As described

in the petition,

disease susceptibility

was evaluated

by intentionally

infecting

the events

and their untransfonned controls

with

late blight

and

soft

rot,

and results confirmed

that silencing

of the target

genes

did not enhance susceptibility

to disease.InAppendix8ofitspetition,Simplotcomparedlaboratoryandfielddiseaseassaysthatweredesignedtogenerateresponsedatatotwoimportantdiseasesofpotato:lateblightcausedbyPhytophthorainfestansandbacterialsoftrotcausedbyErwiniacarotovora(Simplot,2013a).Insomeofthecomparisons,lnnateTMpotatohadmorediseasestressthancontrols.However,withtheexceptionofearlyblightineventFl0atGrandForks,NDin2011,theseobserveddifferencesweresmall,and14otherobservationsdemonstratednodifferencebetweenFl0andcontrolsinstressduetoearlyblight.Therewerefewobservationsforlateblight(P.il?{estans),andnoobservationsweresystematicallycollectedforFusariumdryrot(Fusariumspp.),ringrot(Clavibactermichiganensisspp.sepedonicus),andwaterrot!Pythiumleak(Pythiumultimum).However,therewerenosignificantdifferencesbetweeneventsJ3,J55,J78,H37,andH50andtheircontrolsinthenumberoftubersdiscardedatharvestduetoqualityissues,i.e.rotormold,whilethenumberoftubersdiscardedforeventGIIwassignificantlylowerthanitscontrol(Simplot,2013a),Appendix6.DiscardsforEventsFlO,F37,El2andE24werenotrecorded.Duringthecoldstorageperiodfortrialsinthreelocationsineither2009or2010,pinkrot(Phytophthorae!ythroseptica)andsoftrotandPythiumleakdiseaseswereoccasionallyobservedonbothuntransfonnedandunspecifiedInnateTMpotatoevents,butnodatawereprovided,andthediseaseincidencewasattributedtoenvironmentalsoilconditionsthatfavoredinfection(Simplot,2013a).Whileanumberofvirusesalsoaffecttubers(e.g.,potatoleafrollvirus),thesealsohaveabove-groundsymptomsandsuchsymptomswerenotobservedduringthefieldtrials.Basedonanalysesofresultspresentedinthepetition(Simplot,2013a),thePPRA(USDA-APHIS,2013a)concludedthatlimateTMpotatoisunlikelytobemoresusceptiblethancontrolpotatoestodiseasessuchaslateblightortuberrot.SimplotevaluatedhowInnateTMpotatoperformedinthefieldwithrespecttocontrolpotatoes(Appendix6).Pestanddiseasecharacteristicsweremonitored,anddatawerecollectedthatwouldhelptoanalyzeiftheseeventswereless,equal,ormoresusceptibletopestanddiseasesthancontrolpotatoes(Simplot,2013a).IfPPOwereinvolvedinpestanddiseaseresistance,througharoleinthehypersensitivityresponse,thenonemightexpectasystematicincreaseinthesensitivityofPPOsuppressedInnateTMpotatotoawidevarietyofagents.SimplotdidnotobservesuchachangeinphenotypeintheirfieldobservationoflnnateTMpotato(Simplot,2013a).StandardagronomicpracticesweresufficienttopreventpestsanddiseasesinInnateTMpotatoandnoadditionalcontrolmeasureswererequired(Simplot,2013a).InnateTMpotatoisexpectedtobenomoresusceptibletothesameplantpatl1ogensandinsectpestsastheconventionalpotatovarieties(USDA-APHIS,2013a).StandardfieldagronomicpracticeswillbeusedtocontrolfordiseaseandpestsinIm1ateTMpotatoastheywouldinnon-GEpotatofields.Issue11:Concernthatsilencingo.fasnlgenescouldhavesomeunintendedadverseeffects.ThiscommentwasmadebyanNGO.APHISResponse:TheNationalAcademyofSciences(NAS)hasrankedmethodsofgeneticmodificationaccordingtotherelativelikelihoodofunintendedeffects,suchastheincreaseinaplant'sproductionofcertainallergens.TheNASconsideredmethodsthatinvolverecombinantDNAviaAgrobacteriumtransferofgenesfromcloselyrelatedspecies(theInnateTMmethodusedtoproducethese10eventsisonesuchmethodthatdoesnotinvolvethetransferofgenes)tobeamongthemethodsleastlikelytohaveunintendedeffects-lesslikelythanconventionalpollenbasedcrossingofcloselyrelatedspecies-andfarlesslikelythanmethodssuchasionizingradiationandchemicalmutagenesis,whicharenotsubjecttoregulationandarenotexcludedmethodsundertheNOP(Sciences,2004).DataonperformanceoflnnateTMpotatofromSimplot'spetition(Simplot,2013a)indicatesthattherearenostatisticallysignificantdifferencesfromperfonnanceofconventionalpotatoes.Althoughtotalnitrogenwasnotmeasured,APHISwouldhaveexpectedplantgrowthperformancetohavesufferedifasparaginelevelsweresodepressedthatnitrogentransportandstoragewasnegativelyaffected.Issue12:Yielddataresultsareinconclusive.AcommentfromanNGOstatedthatSimplot'sfieldtrialsdatashowedthat50%ofthetJialyieldsweresignificantlylowerthancontrolyields.Thecormnenteralsostatedthat"highyieldistypicallyoneofthemostimportantcharacteristicsofcropvarietiesthatfarmerslookfor,becauseittendstoresultinhigherprofits."APHISResponse:APHISdoesnotregulatetheactionsofindividualmarketparticipants.Farmerscanchoosetoeitheruseornotusetheloweryieldingpotatoes.ThosedecisionsrestsolelyonmarketparticipantsandareoutsideAPHISregulatoryautl10rity.Issue13:APHIS'scientificanalysisanddataare"incompleteandinadequate."AcommentfromanNGOstatedthatbecauseofuncertainty,APHIS'analysesaredeficient,andAPHISshouldcollecttheirowndata,especiallyonnutritionalcompositionandRNAieffects.APHISResponse:APHISdisagreesthatitsscientificanalysisanddataareincompleteandinadequate.APHIS'analysisanddecisionwithinthePPRAregardingtheplantpestriskposedbyl!mateTMpotatoisbasedonthebestavailablescientificandtechnicalinformation.APHISusedsoundsciencetoinfonnitsregulatorydecisionregardingtheplantpestriskofInnateTMpotato,andhasconcludedthatl!mateTMpotatoisunlikelytoposeaplantpestrisk.APHIScarefullyreviewedtheinfonnationprovidedbythepetitionerandothersandconsideredallotherrelevantinfonnationsufficienttomakethedeterminationontheregulatedstatusoflnnateTMpotato.APHIScarefullyconsideredthepossibleenviromnentalimpactsoftheproposedproduct,andissatisfiedthattheEAdevelopedforInnateTMpotatoisadequateandsufficient.IntheEA,APHIShasconsideredopposingviews,hasrevieweddatasubmittedbythosewhosupportedoropposedthedeterminationofnonregulatedstatus,andhasnotreliedonbiasedinformation.APHIShasincludedananalysisofeachofthealternativesandevaluatedandusedthebestavailableinformationfromvarioussources,includingpeer-reviewedscientificliteraturethatwasreviewedandincorporatedintoAPHIS'analysis.APHISreliedonavarietyofsourcestosupportitsanalysisofthepotentialimpactsofadete1minationofnonregulatedstatusforInnateTMpotato.Thesesourcesinclude,butarenotlimitedto,theSimplotpetitionandappendices,technicalreports,andpeer-reviewedliterature.AsanexampleofthesafetyanddataanalysisofGEcrops,Ricroch(Ricroch,2013)examineddatafromanimalfeedingstudiesand60recentGEvs.non-GEcroplinescomparisons,including33long-tennanimalfeedingstudies,16ofwhichspannedmultiplegenerations.ThecomparisonsshowedthatGEtransformationhaslessimpactonplantexpressionandcompositionthandoesconventionalplantbreeding.Ricroch(Ricroch,2013)notedthatnonewsafetyconcernsraisedinanyofthefeedingstudies,includingthemultigenerationalstudiesandlong-tennstudies.Similarly,Snell(Snelleta!.,2012)revieweddatafrom12long-tennanimalfeedingstudies(includingGEpotato,althoughnotthesetraits)ofdurations>90daystoupto2years,and12multigenerationalstudies(from2to5generations).Nostatisticallysignificantdifferenceswereobservedonanimalhealthparameterswhencomparedwithcontrolanimals.WithregardtothecommentaboutsafetyofRNAi,RNAinterference(RNAi)isanRNA-basedmechanismthatchangesendogenousgeneexpressionineukaryotesincludingplants,insects,fungi,nematodes,andmammals.RNAi-mediatedgenesuppressiongenerallyrequiressequencehomologyofatleast90%betweenthesilencingconstructandthetargetsequencetobesuccessfulandevenhigherdegreesofhomologyover21-23nucleotidestretches(Sharp,200la).AcomplementaritybetweensiRNAs(shortinterferingRNA)andtheirtargetRNAsequencesisnecessaryforaneffectiveandefficientgenesilencing.ShortinterferingRNA-mediatedsilencingofnon-targetgenes,tennedoff-targeteffects(OTE),oftenappearstobecausedbysilencinggeneshomologstothetargetedgeneand/orothergenesshmingpartialsequencecomplementarityorsimilaritytothesiRNA(Jacksoneta!.,2003).Thepotentialunintendedeffectsinbiotechcrops(e.g.,compositionaloragronomicchanges)areimportm1tfactorsintheevaluationofcropsafetyassessmentprocess(Cellinieta!.,2004).RNAiinducedchangescouldbemanifestedincompositionalorphenotypicchangesinthegeneticallymodifiedplant(Parrotteta!.,2010).Accordingtoarecentpublication,(Petricketa!.,2013),GEcropsutilizingRNA-mediatedtechnology,includingRNAi,aresafeforhumanandanimalconsumption.Nucleicacidsarenaturalcomponentsofallfoodsm1dfeedsandpresumedtobesafebasedonlonghistoryofpastconsumption.RNAimediatedgenesuppressiongenerallyrequiressequencehomologyofatleast90%betweenthesilencingconstructandthetargetsequencetobesuccessfulandevenhigherdegreesofhomologyover21-23nucleotidestretches(Sharp,2001b).ItisnotlikelythatthegeneticconstructcomponentsresponsibleforgenesilencingintheInnateTMpotatoeventswouldcontributetosilencingofgenesinothernon-targetorganismsthroughdirectconsumptionofpollenbypollinatorsorthroughsecondaryexposureofbeneficialpredatororparasiticarthropodsorotherpotentialbiologicalcontrolagentsforpotatopests(Laceyeta!.,2001)sincesequencesfromarthropods,bacteria,fungiandvirusesareexpectedtobehighlydivergentfromthesequencesusedtosilencegenesinhmateTMpotatoes.Furthennore,indirectexposurescenariosareunlikelytoleadtoimpactstonon-targetpredatorsandparasiticarthropodssince1)theymaynotreceiveeffectivedoses,2)intracellularamplificationofsiRNA,theactivegenesilencingcomponentderivedfromdsRNA,isnotwidelyfoundininsects,3)environmentalandphysiologicalconditionsinthegutmaydestroytheRNA,4)andtheymaynothavetheappropriatereceptorstoallowtransmembranemovementofdsRNAortheappropriateenzymetodirectRNAi(e.g.Dicer,Argonaute,RdRP,RNAandDNAhelicases)(LundgrenandDuan,2013).Thereisnoconfirmedevidenceinthescientificliterature,thatassociatesconsumptionofplantderivedRNAmoleculesofanykindwithanyhazardsinhumans,othermammals,ordomesticatedanimals"(Carrington,2014).ItisnotlikelythatthegenesilencingintheInnateTMeventswouldcontributetosilencingofothergenesorofftargetaffects.ThePPRA(USDA-APHIS,2013a)showedthattherewerenosignificantdifferencesbetweenanyofthe10InnateTMpotatoeventsandconventionalpotatoesformeanglycoalkaloidtoxincontent.Nonewproteinsareexpectedtobeproducedbasedontheinsertedgeneticelementsandthegeneticmodification.APHISconductedaPPRA,andconcludedthatInnateTMpotatodoesnotconstituteaplantpestrisk(USDA-APHIS,2013a).FDAregulatesfoodsafetyofGEorganismsundertheauthorityoftheFFDCA(21U.S.C.301etseq.).Issue14:APHISdidnotadequatelyconsiderpublichealthimpacts.AcommentfromanNGOstatedthatAPHISimproperly"passesthebucktoFDA"onpublichealthimpacts.ThecommenteralsocriticizedFDA'svoluntaryconsultationprocessas"extraordinarilyweak,"andshouldnotberelieduponbyAPHIS.ThecommenterfurtherstatedthatAPHISdidnotevaluatethe"directandindirectpotentialsideeffectsfromchangesinpathogenresistancelikelycausedbyreducingbrowning."APHISResponse:IntheEA,APHIShasconsideredopposingviews,hasrevieweddatasubmittedbythosewhosupportedoropposedthedetenninationofnomegulatedstatus,andhasnotreliedonbiasedinfonnation.APHIShasincludedananalysisofeachofthealternativesandevaluatedandusedthebestavailableinformationfromvarioussources,includingpeer-reviewedscientificliteraturethatwasreviewedandincorporatedintoAPHIS'analysis.APHISreliedonavarietyofsourcestosupportitsanalysisofthepotentialimpactsofadetenninationofnonregulatedstatusforInnateTMpotato.Thesesourcesinclude,butarenotlimitedto,theSimplotpetitionandappendices,technicalreports,andpeer-reviewedliterature.APHISdisagreeswiththecommenterthatthereisimproperrelianceonFDAforitspublichealthexpertise;instead,FDAistheFederalauthoritythatregulatesfoodsafety.WedisagreethatAPHISshouldtakeonthisroleinsteadofdeferringtotheFDA.Wealsodisagreewiththecommenterthatthevoluntaryconsultationprocessisextraordinarilyweak;especiallygiven thateverydeveloperofabiotechcrophasconsultedwiththeFDApriortomarket.Duringthefirstcommentperiod,APHISreceived43comments,includingthosefrom3growers'associations,5universities,and3agribusinesses,thatInnateTMpotatowillbehealthierthanconventionalpotatoes.Onecommenterfromauniversitystatedthat"theproposedmodificationsofferasimplemethodtoreducethelevelsof(acrylamide)inourfood."Anothercommenteratanotheruniversityassertedthat"nonovelproteinsareproduced,meaningthereisnoknownbiologicalmechanismwherebysilencingthesegenescouldincreaseweedinesspotentialorprovideaplantpestrisk."Acommenterfromathirduniversitystated:"Theprocessresultsinpotatolinesthatdemonstratereducedblackspotbruise,lowasparagine,andlowerlevelsofreducingsugars.Thesearealltraitsthatarecriticaltothepotatoindustryandwillreducepotentialrisktohumansconsumingfriedpotatoproducts."AsdiscussedinSection4.6.1oftheEA,HumanHealth,adecisiontoderegulateInnateTMpotatoshoulddecreaseexposuretoacrylamidebybetween58and72%,asignificantreductioninatoxiccompound(NTP,2011;Simplot,2013a).Further,thedatapresentedinthepetitionshowthattheSimplotInnateTMpotatoeventsareatleastassafeandnutritiousforfoodastheuntransformedcontrols(Simplot,2013a).Thecompositionalanalysesofthe teneventsaresummarizedinthepetition,withdetailedresultsinAppendix9(Simplot,2013a).Issue15:APHISdidnotconsultwithtribes.AcommentfromanNGOstatedthat"APHIShasmadenoshowinginthisEAtoindicatethatithasconsideredthepotentialimpactsofthisactionupontribesorwhetherithassoughtoutanyinputfromtribalofficials."APHISResponse:APHISdisagreeswiththiscomment.PriortothepublicationofthisEA,APHISsentalettertotriballeadersinthecontinentalUnitedStatesonMay3'd,2013.ThislettercontainedinfmmationregardingtheJRSimplotCompanypetitionandtheInnateTMpotatovarieties.Additionally,thissamenotificationalsoaskedtriballeaderstocontactAPHISiftheybelievedthattherewerepotentiallysignificantimpactstotriballandsorresourcesthatshouldbeconsidered.NoresponseswerereceivedbyAPHISfromtriballeadersregardingtheJRSimplotCompanypetitionorInnateTMpotatovarieties.Furthermore,APHISconsideredtheimpacttotribesortribalpropertiesintheEA(Section7.6NationalHistoricPreservationAct[NHPAJof1966asAmended)andthisFONSI(Item8above,directlyunderIntensity).Asaresultofthatanalysis,itwasconcludedtl1atadetenninationofnonregulatedstatusoflnnateTMpotatowillnotadverselyimpactculturalresourcesontribalproperties.Issue16:APHISdidnotadequatelyconsidertheimpactsonbeneficialorganisms,includingpollinators.APHISResponse:Section4.5.1oftheEA,AnimalCmmnunities,discussesprojectedeffectsoflm1ateTMpotatoonnon-targetanimals.ConsumptionofSimplotInnateTMpotatoisunlikelytosubstantiallyaffectnon-targetorganisms,suchasmammals,birds,orinsects.SimplotdatademonstratesthatthecompositionofSimplotIlmateTMpotatodoesnotsubstantiallydifferfromconventionalpotatovarieties(Simplot,2013a).SimplotindicatedthattheyhavesubmittedasafetyandnutritionalassessmentoffoodandfeedderivedfromSimplotIlmateTMpotatotoilieFDAonFebruary12,2013(Simplot,20!3a).FDAispresentlyevaluatingthesubmission.Thereisnoevidenceilia!animalexposuretoSimplotInnateTMpotatowouldhaveanyeffectorbeanylessattractiveasfood,refuge,coverandnestingsitesasnonGEvarietiesofpotatoes.APHISevaluatedintheEA,Simplot'sdataonagronomicperfonnance,diseaseandinsectsusceptibility,andcompositionalprofilesoflm1ateTMpotato.APHISanalysisindicatesnosignificantdifferencesbetweenInnateTMpotatoandnon-transgeniccounterpartsthatwouldbeexpectedtocauseeitheradirectorindirectadverseeffectonnon-targetorganisms.Fieldtrialsconductedovera3-yearperiodwithInnateTMpotatohavenotshownanyobservablesignificantdifferencesbetweenInnateTMpotatoandnon-transgeniccontrols.Becauseofthis,thereisnoscientificreasontoexpectthatilietransformedIlmateTMpotatowouldhaveanegativeimpactonnon-targetorganisms.Insectpopulationdiversityrepresentsonemeasureofgeneralimpacts,andtherewerenodifferencesobservedatvmioustimesduringdevelopmentofthecrop.Intheabsenceofanyobservableacutestressesorimpacts,thereisnoreasontopresumethatlongtennimpactswouldbeexpected,northataneedexiststomonitorforthem.APHIShascarefullyconsideredthepossibleenviromnentalimpactsoftl1eproposedaction,andissatisfiedthattheEApreparedbyAPHISisadequateandsufficient.AsdiscussedinSection2.3.3oftheEA,GeneFlowandWeediness,becausepotatoisprimmilyclonallypropagated,exposureofpollinatorstopollenislimited.Furthennore,thesiteofgenesilencingisprimarilylimitedtothetuberandstolons,nottheleavesandstems,therebyleadingtorestrictedaccessofthegenesilencingtoinsectsandothernontargetorganisms.Muttucumarueta!.(Muttucwnaruetal.,2014)notesthat"thestrategyoftargetingasparaginesynthesisspecificallyinthetubermakessensebecauseasparaginehasbeenshownnottobeamajortransportedaminoacidinpotato,sothefreeasparaginetl1ataccumulatesintubersmust besynthesizedthere."Fmihermore,nonewproteinsarebeingintroducedasaproductoflnnateTMteclmology(Simplot,2013a).Llorenteeta!.(20I0)fednonbrowningpotatotransformedbygenesilencingtomice,anddeterminedthattherewerenoadverseeffectstothemice.Llorenteetal.(2010)alsodetenninedthatgivenachoice,miceconsumedsignificantlymoreoftheGEpotatoesthantheconventionalpotatoes,andsuggestedthattheodoroftheGEpotatoesmightbemoreattractivetothemice(Llorenteeta/.,2010).ThefieldtrialresultsreportedbySimplot(Simplot,2013a)alsodemonstratedthattherewerenodifferencesbetweeninfestationofinsectsintheInnateTMpotatoescomparedtotheiruntransfonnedcontrols.TheEAhasreportedonthesafetyoflnnateTMpotatointheenvironmentalconsequencesandcumulativeimpactssectionsundervariousheadings,includingthoseonanimals,plants,biodiversity,microbesandhumanhealth.Baseduponinfonnationandanalysispresentedinthepetition,PPRA,andEA,APHIShasnotidentifiedanypotentialforhanntotheenvironmentfromInnateTMpotatoIssue17:APHISdidnot''properly"consideritsobligationstomigrato1ybirds.AcommentfromanNGOstatedthatAPHISfailedtoproperlyconsideranddiscloseitsobligationstomigratorybirds.Specifically,ExecutiveOrder13186requiresfederalagenciestodevelopandimplementaMemorandumofUnderstanding(MOU)withtheFWStopromotetheconservationofmigratorybirdpopulations.Further,thatAPHISdidnotadequatelyassessimpactstomigratorybirds,andthatAPHISdidnotconsiderthepennittingrequirementsthatallowthe"take"ofamigratorybirdundercertainactivities,noneofwhichincludethetypesofactivitiesdiscussedintheEA,andthereforenotakeofevenasinglemigratorybirdisallowed.APHISResponse:APHISdisagreeswiththecommenter.First,asrequiredbyExecutiveOrder13186,APHIShasinplaceasignedMOUwiththeFWS(APHIS-USFWS,2012).Second,APHIShasconsidereditsobligationsundertheMigratoryBirdTreatyActandaclmowledgedintheEAthatmigratorybirds,particularlywaterfowl,mayforageinagriculturalfieldsincludingpotatofields.However,APHIScametotheconclusionthatgrantingnonregulatedstatustoInnateTMpotatowouldhavenoimpactonanymigratorybirdsbecauseInnateTMpotatoissimilartootherpotatovarieties,withtheexceptionthesilencingoffourdifferentgenesinpotato:asparaginesynthetase-](Asnl),polyphenoloxidase-5(Ppo5),potatophosphorylaseL(PizL)andthestarch-associatedRlgene(RJ).ThesuppressionofAsnlresultsinpotatoeswithreducedfreeasparagine,andthesuppressionofPhLandRlresultsinpotatoeswithalowercontentofreducingsugars.Collectively,thesilencingofthese3genesshouldresultinpotatotuberswithareducedacrylamidepotential.ThesuppressionofPpo5confersthe!!mateTMpotatowithanon-browningphenotyperesultingintuberswithreducedblackspotbruising(Simplot,2013b),(USDAAPHIS,2013b).AHIShasdeterminedthatthereisnoreasontobelievethatreducedfreeasparagineorreducedblackspotbruisingwouldhaveanyeffectonmigratorybirds.TheapplicantprovideddatatodemonstratethecompositionalequivalencyoflnnateTMpotatoand

# other potato varieties

currently

grown.

The modifications

did

not alter

the quality

of potato

as food other

than lower

levels

of acrylamide

after cooking,

and lower

black

spot bruise.

There would

be

no effect

from consumption

of InnateTM

potato

plant

parts because

there

is nothing different

between

the plant

parts

of these varieties

and plant

parts

of other potato varieties already

in production.

Further,

there

is

no reason

to suspect

that migratory

birds would interact with InnateTM

potato

any differently

than

any other potato

plant.

Lastly,

no "take"

of

a migratory bird

is expected

as

a result

of growing

InnateTM

potato,

and APHIS

could

not detennine

any mechanism

by which

take would

occur,

or would

occur

any differently

than production

of any otl1er potato variety. Issue

18: 

# APHIS

did

not "adequately"

assess impacts

on threatened

and endangered

species. One commenter

from

an NGO

stated

that InnateTM

potato

may significantly

affect threatened

and endangered

species

(TES)

and expressed

concern

that APHIS

had "failed

to consult"

with

the United

States

Fish

and Wildlife

Service (USFWS)

or the National

Marine Fisheries

Service (NMFS)

on

the potential

effects

to threatened

and endangered

species

and their critical habitats, as required

under section

7 of the Endangered

Species

Act (ESA),

and

that "APHIS

must prove" its deregulation

oflnnateTM

Potato

will neither jeopardize

any species

nor hann

any critical habitat anywhere

the crop

may

be grown.

Furtl1er,

that APHIS

failed

to obtain information

from USFWS/NMFS

on species

that may

be present

in the area where InnateTM

potato

would

be grown. APHIS Response: APHIS disagrees

with

this comment.

As required

under Section

7 of the ESA, APHIS considered

the potential

for effects

from

the proposed determination

of nonregulated

status

for InnateTM

potato

on federally

listed threatened

and endangered

species

and species proposed

for listing,

as well

as effects

on designated

critical

habitat

and habitat proposed

for designation. APHIS considered

possible

effects

on

all listed species

as well

as

all species proposed

for listing as well

as

all designated

critical

habitat

and habitat proposed

for designation

in States

where potatoes

are commercially

grown.

Species infom1ation

was obtained

from

the USFWS Environmental

Conservation

Online

System

(ECOS;

as accessed

February

19,2014

at http:// ecos.fws.

gov/tess public/pub/stateListingAndOccurrence.

j 

# sp) (USDA -APHIS,

20 14a

), (USDA-APHIS,

2014b).

After analyzing

the potential

for

any effect, APHIS concluded

that

tl1e detennination

of nonregulated

status

for InnateTM

potato

will have

no effect

on any federally listed threatened

and endangered

species

or species proposed

for listing,

as well

no effect

on any designated

critical

habitat

or habitat proposed

for designation.

Because

of this

no effect detennination,

consultation

with,

or tl1e concurrence

of,

the USFWS

and/or

NMFS

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