i 

# JR Simplot Company Petition (14

- 093

- 01p ) for Determination of Nonregulated Status for Innate TM 

# Potatoes with Late Blight Resistance, Low Acrylamide Potential, Reduced Black Spot and Lowered Reducing Sugars: Russet Burbank Event W8

OECD Unique Identifier : SPS

- 000W8

- 4



# Draft Environmental Assessment

February 2015

Agency Contact Cindy Eck Biotechnology Regulatory Services

4700 River Road
USDA, APHIS
Riverdale, MD 20737 Fax: (301) 734

- 8669

The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, se x, religion, age, disability, political beliefs, sexual orientation, or marital or family status. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, l arge print, audiotape, etc.) should contact USDA’S TARGET Center at (202) 720

– 2600 (voice and TDD).

To file a complaint of discrimination, write USDA, Director, Office of Civil Rights, Room 326

– W, Whitten Building, 1400 Independence Avenue, SW, Washington, DC 20250

– 9410 or call (202) 720

– 5964 (voice and TDD). USDA is an equal opportunity provider and emp loyer.ii

Mention of companies or commercial products in this report does not imply recommendation or endorsement by the U.S. Department of Agriculture over others not mentioned. USDA neither guarantees nor warrants the standard of any product mentioned. Product names are mentioned solely to report factually on available data and to provide specific information.

This publication reports research involving pesticides. All uses of pesticides must be registered by appropriate State and/or Federal agenci es before they can be recommended.

## TABLE OF CONTENTS PAGE

iii TABLE OF CONTENTS

LIST OF FIGURES

................................ ................................ ................................ ........................ vii

LIST OF TABLES

................................ ................................ ................................ .......................... vii

ACRONYMS AND ABBREVIATIONS

................................ ................................ ........................... viii

1 PURPOSE AND NEED

................................ ................................ ................................ ............... 1 1.1 Background

................................ ................................ ................................ ........................... 1

1.1.1 The APHIS Regulatory Authority

................................ ................................ .............. 1

1.1.2 Purpose of this Product

................................ ................................ ............................ 2 1.2 Coordinated Regulatory Framework for Genetically

- Engineered Organisms

...................... 3

1.2.1 USDA

- APHIS

................................ ................................ ................................ .................... 3 1.2.2 Environmental Protection Agency

................................ ................................ .................. 4 1.2.3 Food and Drug Administration

................................ ................................ ....................... 5 1.3 Purpose and Need for This APHIS Action

................................ ................................ .............. 5

1.3.1 Public Involvement

................................ ................................ ................................ ......... 6 1.3.2 Public Involvement Approach for This EA

................................ ................................ ...... 7

1.4 Issues Considered

................................ ................................ ................................ .................. 7

2 AFFECTED ENVIRONMENT

................................ ................................ ................................ ...... 9

2.1 Agricultural Production and Agronomic Practices of Potato

................................ ........... 9 2.1.2 General Agronomic Practices

................................ ................................ ....................... 12

2.2 Physical Environment

................................ ................................ ................................ .......... 25

2.2.1 Water Resources

................................ ................................ ................................ .......... 25 2.2.2 Soil Quality

................................ ................................ ................................ .................... 26 2.2.3 Air Quality

................................ ................................ ................................ ..................... 28 2.2.4 Climate Change

................................ ................................ ................................ ............. 28 2.3 Biological Resources

................................ ................................ ................................ ............ 29

2.3.1 Animal Communities

................................ ................................ ................................ .... 29

## TABLE OF CONTENTS PAGE

(Continued)

iv 2.3.2 Plant Communities

................................ ................................ ................................ ....... 30

2.3.3 Gene Flow and Weediness

................................ ................................ ........................... 31
2.3.4 Microorganisms

................................ ................................ ................................ ............ 32 2.3.5 Biodiversity

................................ ................................ ................................ ................... 33

2.4 Human and Animal Health

................................ ................................ ................................ .. 34

2.4.1 Consumer Health

................................ ................................ ................................ .......... 34

2.4.2 Worker Health

................................ ................................ ................................ .............. 37

2.4.3 Animal Feed

................................ ................................ ................................ .................. 38

2.5 Socioeconomics

................................ ................................ ................................ ................... 40

2.5.1 Domestic Economic Environment

................................ ................................ ................ 40

2.5.2 Trade Economic Environment

................................ ................................ ...................... 44 2.5.3 Organically Certified Economic Environment

................................ .............................. 44

3. ALTERNATIVES

................................ ................................ ................................ ............................ 47 3.1 No Action Alternative: Continuation as a Regulated Article

................................ .............. 47

3.2 Preferred Alternative: Determination That Simplot InnateTM W8 Potato Is No Longer a Regulated Article

................................ ................................ ................................ ............................ 47 3.3 Alternatives Considered But Rejected from Further Consideration

................................ ... 47 3.3.1 Prohibit Any Simplot InnateTM W8 Potato from Being Released

................................ .. 48 3.3.2 Approve the Petition in Part

................................ ................................ ......................... 48 3.3.4 Requirement of Testing for Simplot InnateTM W8 Potato

................................ ............. 49 3.4 Comparison of Alternatives

................................ ................................ ................................ 49

4 ENVIRONMENTAL CONS EQUENCES

................................ ................................ ............................ 55 4.1 Environmental Consequences

................................ ................................ ............................. 55 4.2 Scope of Analysis

................................ ................................ ................................ ................. 55 4.3 Agricultural Production of Potato

................................ ................................ ....................... 56 4.3.1 Acreage and Area of Potato Production

................................ ................................ ....... 56
4.3.2 Agronomic Practices

................................ ................................ ................................ ..... 56

4.3.3 Potato Seed Production

................................ ................................ ............................... 58

## TABLE OF CONTENTS PAGE

(Continued)

v 4.3.4 Organic Potato Production

................................ ................................ ........................... 58

4.4 Physical Environment

................................ ................................ ................................ .......... 59

4.4.1 Water Resources

................................ ................................ ................................ .......... 59 4.4.2 Soil Quality

................................ ................................ ................................ .................... 60 4.4.3 Air Quality

................................ ................................ ................................ ..................... 61 4.4.4 Climate Change

................................ ................................ ................................ ............. 61 4.5. Biological Resources

................................ ................................ ................................ ........... 62

4.5.1 Animal Communities

................................ ................................ ................................ .... 62

4.5.2 Plant Communities

................................ ................................ ................................ ....... 65

4.5.3 Gene Flow and Weediness

................................ ................................ ........................... 66 4.4.5 Biodiversity

................................ ................................ ................................ ................... 67

4.6 Human and Animal Health

................................ ................................ ................................ .. 68

4.6.1 Human Health

................................ ................................ ................................ .............. 68 4.6.2 Worker Safety

................................ ................................ ................................ ............... 6 9

4.6.3 Animal Feed

................................ ................................ ................................ .................. 70

4.7.1 Domestic Economic Environment

................................ ................................ ................ 70

4.7.2 Trade Economic Environment

................................ ................................ ...................... 72

5 CUMULATIVE IMPACTS

................................ ................................ ................................ ......... 73 5.1 Assumptions Used for Cumulative Impacts Analysis

................................ .......................... 73 5.2 Past and Present and Reasonably Foreseeable Actions

................................ ..................... 74

6 THREATENED AND ENDAN GERED SPECIES

................................ ................................ ........... 77

6.1 Potential Effects of Si mplot InnateTM W8 potato on TES and Critical Habitat

................ 79

7 CONSIDERATION OF EXE CUTIVE ORDERS, STAND ARDS, AND TREATIES R ELATING TO ENVIRONMENTAL IMPACT S

................................ ................................ ................................ . 83 7.1 Executive Orders with Domestic Implications

................................ ................................ .... 83 7.2 International Implications

................................ ................................ ................................ ... 88 7.3 Compliance with Clean Water Act and Clean Air Act

................................ .......................... 89 7.4 Impacts on Unique Characteristics of Geographic Areas

................................ .................... 89

## TABLE OF CONTENTS PAGE

(Continued)

vi 8 REFERENCES

................................ ................................ ................................ .......................... 91vii

LIST OF FIGURES

Figure 1. Potato Growing Regions of the United States (USDA

- NASS, 2007)

................................ ............ 11

LIST OF TABLES

Table 1. Agronomic Inputs for Russet Varieties

................................ ................................ ......................... 10

Table 2. Major Potato Production States in 2013

................................ ................................ ....................... 11

Table 3. Major Insect Pests of Potato

................................ ................................ ................................ ........ 15

Table 4. Major Diseases of Potato

................................ ................................ ................................ ............. 16

Table 5. Major Weeds of Potato

................................ ................................ ................................ ................ 22

Table 6. US Per Capita Potato Consumption 2012 (lb/person/yr)

................................ ............................. 34

Tab le 7. US 2012 Potato Utilization

................................ ................................ ................................ ........... 39

Table 8. Summary of Issues of Potential Impacts and Consequences of Alternatives

.............................. 49viii ACRONYMS AND ABBREVIATIONS

AMS Agricultural Marketing Service (within USDA)
AOSCA American Organization of Seed Certifying Agencies
APHIS Animal and Plant Health Inspection Service (within USDA AMS)
BRS Biotechnology Regulatory Services (within USDA

– APHIS)
CAA Clean Air Act
CBD Convention on Biological Diversity CEQ Council on Environmental Quality
CFR Code of Federal Regulations (United States)
CH 4 M ethane
CO carbon monoxide
CO 2 carbon dioxide
CWA
DNA Clean Water Act

deoxyribonucleic acid
EA Environmental A ssessment
EIS E nvironmental Impact S tatement
EO Executive Order
EPA US Environmental Protection Agency
ESA Endangered Species Act of 1973
FDA US Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act

FFP food, feed, or processing
FIFRA
FONSI FQPA Federal Insecticide, Fungicide, and Rodenticide Act

Finding of No Significant Impact Food Quality Protection Act

FR
FWS Federal Register

Fish and Wildlife Service (of the U.S)
GE genetically engineeredix ACRONYMS AND ABBREVIATIONS

GHG greenhouse gas

IPM
IPPC Integrated Pest Management

International Plant Protection Convention
ISPM International Standard for Phytosanitary Measures
LMO
M
NGO living modified organism

m illion

non

- government organization
NO 2 nitrogen dioxide
N 2 O nitrous oxide NAAQS National Ambient Air Quality Standards
NABI North American Biotechnology Initiative
NAPPO North American Plant Protection Organization
NEPA National Environmental Policy Act (of 1969 and subsequent amendments)
NHPA
NMFS
NOP
NPS
NRC
NRCS
PIP
PM
PPA

PPM
PPRA
RNA
SSA
TES
TPS National Historic Preservation Act

National Marine Fisheries Service National Organic Program (of USDA AMS)

non

- point source
National Research Council
Natural Resources Conservation Service

p lant

- incorporated protectants

p articulate matter
Plant Protection Act parts per million
Plant Pest Risk Assessment
ribonucleic acid sole source aquifer threatened and endangered species true potato seedx ACRONYMS AND ABBREVIATIONS

U

. S

. USDA
USDA

- ERS
USDA

- FAS
USDA

- NASS
USDA

- NOP
WPS United States

US Department of Agriculture
US Department of Agriculture

- Economic Research Service
US Department of Agriculture

- Foreign Agricultural Service
US Department of Agriculture

- National Agricultural Statistics Service
US Department of Agriculture

- National Organic Program Worker Protection Standard (for agricultural pesticides)1

1 PURPOSE AND NEED

1.1 Background
J.R. Simplot 1 of Boise, Idaho, submitted petition 14

- 093

- 01p to the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) in March 2014 , seeking a determination of nonregulated status for Simplot Innate TM W8 p otato genetically engineered (GE) with late blight resistance, low acrylamide potential, reduced black spot and lower reducing sugars

. The petitio n was deemed complete by APHIS o n June 26, 201 4 , and was published in the Federal Register on Nov ember 10, 2014 ( 79 FR 66689

- 66690 )

. Public comments were due by January 9, 2015. Simplot InnateTM W8 p otato is currently regulated under 7 CFR part 340. Interstate movements and confined field releases of Simplot InnateTM W8 p otato were conducted under notifications acknowledged by APHIS in 2012 and 2013

. These field trials were conducted in Idaho, Minnesota, North Dakota, Washington, and Wisconsin

. Data resulting from these fi eld trials are similar to data requirements for other petitions submitted to APHIS and described in Simplot’s InnateTM W8 p otato petition ( Simplot, 2014 ) and analyzed for plant pest risk in the APHIS Plant Pest Risk Assessment (PPRA) ( USDA

- APHIS, 2014b )

. The petition stated that APHIS should not regulate Simplot InnateTM W8 p otato because it does not present a plant pest risk. In the event of a determination of nonregulated status, the nonregulated status would include Simplot InnateTM W8 p otato , any progeny derived from crosses between Simplot InnateTM W8 p otato and conventional potato , and crosses of Simplot InnateTM W8 p otato with ot her biotechnology

- derived potatoes that are no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provision s of the Plant Protection Act.

1.1.1 Regulatory Authorit y
“Protecting American agricul ture” is the basic charge of the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS). APHIS provides leadership in ensuring the health and care of plants and animals. The agency improves agricultural productivity an d 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 farm income.
APHIS is responsible for regulating GE organisms and plants under the authority of plant pest provisions in the Plant Protection Act of 2000, as amended (7 USC § 7701 et seq.) to ensure that they do not pose a plant pest risk to the environment. The FDA regulates GE organisms under the authority of the Federal Food, Drug, and Cosmetic Act. The FDA is responsible for ensuring the safety and proper labeling of all plant

- derived foods and feeds, including those that are genetica lly engineered. To help developers of food and feed derived from GE

1 Referred to as the JR Simplot Company or Simplot hereinafter2

crops comply with their obligations under Federal food safety laws, FDA encourages them to participate in a voluntary consultation process. All food and feed derived from GE crops curren tly on the market in the United States have successfully completed this consultation process. The FDA policy statement concerning regulation of products derived from new plant varieties, including those genetically engineered, was published in the Federa l Register on May 29, 1992 (57 FR 22984

- 23005). Under this policy, FDA uses what is termed 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 distribu tion of bioengineered food.
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 Cosmetic Act (FFDCA) and regulates certain biological control organisms under the Toxic Substances Control Act (TSCA). The EPA is responsible for regulating the sale, distrib ution and use of pesticides, including pesticides that are produced by an organism through techniques of modern biotechnology.

1.1.2 Purpose of this Product
Simplot’s Innate TM potato, which contains traits for lowered acrylamide potential and reduced black spot bruise, was de termined to be non regulated on November 10, 2014 ( 79 FR 66688 ). The Simplot Innate TM W8 potato is a Russet Burbank which contains these traits, plus two other traits for lowered reducing suga rs and late blight resistance. As discussed in Simplot’s petition for nonregulation of Simplot Innate TM potato ( Simplot, 2013 ) , APHIS’ Plant Pest Risk Assessment (PPRA) ( USDA

- APHIS, 2013a ) and subsequent Environmental Assessment ( EA ) ( USDA

- APHIS, 2014a ) , Simplot Innate TM potato was genetically engineered to provide a potato that produces up to a 70% reduction of the neurotoxicant and pu tative carcinogen, acrylamide, and decreased potential for black spot bruise. Acrylamide forms in potatoes and other starchy foods under high

- temperature cooking conditions ( O'Brien et al. , 1989 ) , and the acrylamide reduction potential in Simplot Innate TM W8 potato is a si gnificant human health benefi t, helping to address consumer concerns about the health effects of acrylamide ingestion ( NTP, 2012 ; FDA, 2013c )

. B lack spot bruise is a post

harvest physiological dis order primarily resulting from t he han dling of potato tubers during harvest, transport, and processing, and refers to the black or grayish color which may form in the interior of damaged potatoes ( USDA

- APHIS, 2014b )

. This blackening negativ ely affects tuber quality in processing French fries and chips, posing an economic deficit to growers since damaged potatoes must be trimmed or culled, significantly reducing yield ( USDA

- APHIS, 2014b )

. The technology used to produce Simplot Innate TM potato has been utilized to introduce two new additional traits into the most popular variety of potato for processing, Russet Burbank ( NPC, 2013 )

. These new traits are late blight resistance and lowered reducing sugars. There currently are no varieties available that produce potatoes with late blight resistance ( McGrath, 2010 ) , low reducing sugars, low acrylamide formation, and reduced black spot and at the same time maintaining all the other compositional, nutritional and flavor traits required by the food industry ( Simplot, 2014 )

. Late blight, caused by the oomycete pathogen, Phytoph th ora infestans , is the most destructive potato disease3

worldwide , and was responsible for the Irish potato famine of the 1840s. Contr ol of this disease incurs significant costs to growers owing from fungicide applications and yield loss from diseased plants ( Fry, 2008 )

. Reducing sugars increase over the length of time that potatoes are stored prior to use in processing, with high levels leading to unacceptably brown fries and chips and alteration in flavor, contributing to acrylamide formation, and resulting in consumer rejection ( Bhaskar et al. , 2010 )

. Processors typically reject potato loads with a reducing sugar content above 2%, which comprises about 20% of potatoes produced ( Simplot, 2014 ) , so a trait which prevents accumulation of reducing sugars to unacceptably high levels would be economically beneficial to growers

. The intended purpose of the W8 potato line is to provide the potato processing industry with new varieties that possess late blight resistance , reduced acrylamide potential in certain processed or heated potato products , reduced black spot bruise , and lowered reducing sugars. All of these changes are intended to b enefit potato consumers, producers, and processors. The late blight resistance trait may lower the need for fungicides for control of late blight disease and may lessen the discards of potatoes that are infected which may lead to increased yield and less chemical residues on potatoes, fields and
waste water. The low acrylamide potential is intended to benefit consumers because of concerns about the health effects of ingesting acrylamide, and to benefit the industry relative to Proposition 65 in the State of California . The reduced black spot bruise is intended to benefit consumers by providing a higher quality product, to benefit producers by reducing culls at delivery, and to benefit processors by reducing pick

- outs. By lowering reducing sugars with the use of the W8 potato line, storage of potatoes for the fry and chip market could be accomplished at a lower temperature which would lower incidence of storage diseases and keep taste/color quality in the desired ranges.

1.2 Coordinated Regulatory Framewor k for Genetically

- Engineered Organisms
In 1986, the Office of Science and Technology Poli c y (OSTP) described a comprehensive Federal regulatory policy for ensuring the safety of biotechnology research and products entitled “ The Coordinated Framework for the Regulation of Biotechnology ” ( henceforth referred to here as the Coordinated Framework). The Coordinated Framework explains how F ederal agencies will use existing Federal statutes to ensure public health and environmental safety while maintaining regu latory flexibility to avoid impeding the growth of the biotechnology industry. The Coordinated Framework is based on several important guiding principles: (1) agencies should define those transgenic organisms subject to review to the extent permitted by t heir respective statutory authorities; (2) agencies are required to focus on the characteristics and risks of the biotechnology product, not the process by which it was created; (3) agencies are required to exercise oversight of GE organisms only when ther e 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 APHIS, the Environmental Protection Agency (EPA), and the Food and Drug Adm inistration (FDA). A summa ry of each role follows.

1. 2

. 1 USDA

- APHIS
APHIS regulations at 7 Code of Federal Regulations (CFR) part 340, which were promulgated pursuant to authority granted by the PPA, as amended (7 United States Code (U.S.C.) 7701

– 7772), r egulate the4

introduction (importation, interstate movement, or release into the environment) of certain GE organisms and products. A GE organism is no longer subject to the plant pest provisions of the PPA or to the regulatory requirements of 7 CFR part 3 40 when APHIS determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated article if the donor organism, recipient organism, vector, or vector agent used in engineering the organism belongs to one of the taxa listed i n the regulation (7 CFR 340.2) and is also considered a plant pest. A GE organism is also regulated under Part 340 when APHIS has reason to believe that the GE organism may be a plant pest or APHIS does not have information to determine if the GE organism is unlikely to pose a plant pest risk.
A person may petition the agency for a determination that a particular regulated article is unlikely to pose a plant pest risk, and, therefore, is no longer regulated under the plant pest provisions of the PPA or th e regulations at 7 CFR 340. Under § 340.6(c)(4), the petitioner must provide information related to plant pest risk that the agency may use to determine whether the regulated article is unlikely to pose a plant pest risk. A GE organism is no longer subje ct to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the PPA when APHIS determines that it is unlikely to pose a plant pest risk.

1. 2 .2 Environmental Protection Agency
The EPA is responsible for regulating the sale, distribution, and use of pesticides, including those that are expressed by an organism modified using techniques of modern biotechnology. Such pesticides are regulated by EPA as plant

- incorporated protectant s (PIPs) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq. ) . EPA also regulates certain biological control organisms under th e Toxic Substances Control Act (15 U.S.C. 53 et seq .). Before planting a crop containin g a PIP, a company must seek an experimental use permit (EUP) from EPA. Commercial production of crops containing PIPs for purposes of seed increase and sale requires a FIFRA Section 3 registration with EPA. Under FIFRA (7 U.S.C. 136 et seq. ), EPA requir es registration of all pesticide products for a ll specific use s prior to distribution f or sale. Before granting a registration, EPA evaluates the toxicity of the ingredients of the pesticide product ; the particular site or crop on which it is to be used; the amount, frequency, and timing of its use; storage and disposal requirements . Prior to registration for a new use for a new or previously registered pesticide, EPA must determine through testing that the pesticide does n ot cause unreasonable adverse ef fects on humans, the environment, and non

- target species , when used in accordance with label instructions. EPA must also approve the language used on the pesticide label in accordance with 40 CFR part 158. Once registered, a pesticide may only be legally used in accordance with directions and restrictions on its label. The purpose of the label is to provide clear directions for effective product performance , while minimizing risks to human health and the environment. The Food Quality Protection Act (FQPA) of 1996 amended FIFRA, enabling EPA to implement periodic registration review of pesticides to ensure they are meeting current scientific and regulatory st andards of safety and continue to have no unreasonable adverse effects ( US

- EPA, 2011c )

. EPA also sets tolerances (maximum residue levels) or establishes an exemption from the requirement for a tolerance, under the Federal Food, Drug, and Cosmetic Act (FFDCA). A tolerance is the amount of pesticide residue that can remain on or in food for human consumption or animal feed . B efore establishing a pesticide tolerance, EPA is required to reach a safety determination based on a finding of5

reasonable certainty of no harm under the FFDCA, as amended by the FQPA. FDA enforces the pesticide tolerances set by EPA.

Accor ding to Simplot’s petition, an experimental use p ermit (EUP) application was submitted to EPA on December 16, 2013, for field testing of Simplot InnateTM W8 potatoe s. A n EUP, also for Simplot InnateTM W8 potatoe s potatoes, with a Petition for Temporary Tolerance Exemption , was submitted February 20, 2014. A Section 3 Registration will be filed after experiments are completed under the Simplot InnateTM W8 potatoe s EUPs ( Simplot, 2014 )

.

1. 2 .3 Food and Drug Administration
FDA regulates GE organisms under the authority of the FFDCA (21 U.S.C. 301 et seq. ). The FDA published its policy statement concerning regulation of products derived from new plant varieties, including those deriv ed from genetic engineering, on May 29, 1992 ( 57 FR 22984 ) . Under this policy, FDA implements a voluntary consultation process to ensure that human food and animal feed safety issues or other regulatory issues, such as labeling, are resolved before commercial distribution of food derived from GE products . This voluntary consultation process provides a way for developers to receive assistance from FDA in complying with their obl igations under Federal food safety laws prior to marketing.
In June 2006, FDA published recommendations in “Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non

- Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use ” ( US

- FDA, 2006 )

. This establishes voluntary food safety evaluations for new non

- pesticidal proteins produced by new plant varieties intended to be used as food, including GE plants. Early food safety evaluations help make sure that potential food safety issues related to a new protein in a new plant variety are addressed early i n development. These evaluations are not intended as a replacement for a biotechnology consultation with FDA, but the information may be used later in the biotechnology consultation. The J.R. Simplot Company submitted a letter of consultation on April 14, 2014 , which FDA is still reviewing (BNF No. 000146).

1.3 Purpose and Need for This APHIS Action
APHIS respond s to petitioners that request a determination of non regulated status of GE organisms (7 CFR 340.6) , including GE p lants such as Simplot Innate TM W8 p otato . When a petition for nonregulated
status is submitted, APHIS performs analyses to determine if the GE organism poses a plant pest risk. Under § 340.6(c)(4) , the petitioner is required to provide information related to plant pest risk that the agency may use to determine whether the r egulated article is unlikely to pose a plant pest risk. A GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the PPA when APHIS determines that it is u nlikely to pose a plant pest risk.
In this EA, APHIS is respond ing to a petition from Simplot requesting a determination of nonregulated
status for Simplot InnateTM W8 p otato . AP HIS consi der s the potential environmental effects of an agency determination of nonregulated status of Simplot InnateTM W8 p otato consistent with regulations for implementing the National Environmental Policy Act (NEPA ; 40 CFR parts 1500

- 1508 ) , and the APHIS NEPA

- implementing regulations and proced ures (7 CFR part 1b, and 7 CFR part 372). This EA specifically6

evaluate s the effects on the quality of the human environment that may result from a determination of nonregulated status for Simplot InnateTM W8 p otato

.

1. 3 .1 Public Involvement
APHIS routinely seeks public comment on EAs prepared in response to petitions seeking a determination of nonregulated status of a regulated GE organism

. APHIS does this through a notice published in the Federal Register

. Through a March 6, 2012 , notice p ublished in the Federal Register 2
, APHIS implement ed changes to the way it solicits public comment when considering petitions for determinations of nonregulated status for GE organisms . The purpose of this change was to allow early public involvement in t he process

. As identified in this notice , APHIS publish es two separate notices in the Federal Register for petitions for which APHIS prepares an EA. The first notice announce s t he availability of the petition; the second announce s the availability of the APHIS decision

- making documents. The new process allows for public involvement by establishing a comment period after each of the two notices published in the Federal Register

. First Opportunity for Public Involvement:

Once APHIS judges a petition complete, a 60

- day comment period is established for the public to submit comments to assist the Agency in the development of it s EA and PPRA. Th e availability of the petition for public comment is announced in a Federal Register notice.

Secon d Opportunity for Public Involvement

T he draft PPRA and draft EA are developed , and a notice of their availability is published in a second Federal Register notice. This second notice follows one of the following two approaches for public participation ba sed on whether or not APHIS de termines the petition for nonregulated status for a GE organism involves substantive new issues:
Approach 1 . For GE organisms that do not involve substantive new issues

T his is used when APHIS de termines , based on a review of the petition and its evaluation and analysis of public submissions received during the 60

- day commen t period for the petition, that the GE organism does not involve new biological, cultural, or ecological issues

. Agency criteria for this decisio n include a determination that the nature of the modification is not novel or th at the Agency has a high degree of familiarity with the organism through previous regulatory actions , or both

. After this determination is made, APHIS conducts the necessary analysis and prepares its PPRA, EA, and finding of no significant impact (FONSI) . Once completed, APHIS publish es a notice in the Federal Register announcing its preliminary regulatory determi nation and the availability of the EA, FONSI, and PPRA for a 30

- day public review and comment period.

Unless information received in public comments warrant s substantially changing the PPRA or EA analysis and determination, the Agency’s preliminary regulat ory determination become s effective . No further

2 This notice can be accessed at: http://www.gpo.gov/fdsys/pkg/FR

- 2012

- 03

- 06/pdf/2012

- 5364.pdf7

Federal Register notices are published announcing the final regulatory determination. The Agency post s this public notification in an announcement on the APHIS website.
Approach 2. For GE organisms involvi ng substantive new issues not previously analyzed
This pro tocol is used when a petition is for nonregulated status for a novel GE organism . A novel organism is one that is not identical with or sufficiently similar to organisms determined previously by APHIS to have nonregulated status . Examples include organisms with new gene modifications that could have substantial biological, cultural, or ecological effects not previously analyzed. For this process, APHIS prepares draft s of a PPRA and an EA , and then solicits further comments during a 30

- day period that is announced in a Federal Register notice. APHIS review s and evaluate s comments and other relevant information . APHIS then revise s the PPRA as necessary and prepare s a final EA. Following preparation of these documents, APHIS approve s or den ies the petition, then announces its decision in the Federal Register

, and provides notice of the availability of the final EA, PPRA, NEPA decision document, and regulatory determ ination. More details about this expansion of opportunities for stakeholder review and comment are available in the Federal Register notice published on March 6, 2012 3

.

1. 3 .2 Public Involvement Approach for This EA

APHIS has de termined that the protocol fo r preparation of this EA will follow Approach 2. The Agency also considered public comments submitted for other EAs of GE organisms, and concerns described in lawsuits or expressed by various stakeholders. These issues, including those regarding the agricultural production of Simplot InnateTM W8 p otato using various production methods and the environmental and food/feed safety of GE plants
, were addressed to analyze the potential environmental impacts of Simplot InnateTM W8 p otato

. The petition was published in the Federal Registe r on November 10, 2014 (79 FR 66689

- 66690)

. Public comments were due by January 9, 2015. A total of 130 individual comments were received, of which 60 supported the petition, and 68 opposed the petition. Of the 68 opposing comments, one contained an attachment with 22,673 signatures; 22 comments were substantially similar to each other; and 7
comments were submitted by one individual. Of the 60 comments favoring determination of nonregulation, 2 were duplicates.

1.4 Issues Considered

The list of resource areas considered in this EA was developed by APHIS through experience in considering public concerns and issues identified from public comments submitted for this petition and other EAs of GE organisms. The resource areas address concerns raised in previous and unrelated

3 This notice can be accessed at: http://www.gpo.gov/fdsys/pkg/FR

- 2012

- 03

- 06/pdf/2012

- 5364.pdf8

lawsuits, as well as issues that have been raised by various stakeholders for this p etition and in the past. The resource areas considered in this EA can be categorized as follows:
Agricultural Production Considerations:

 Land Use of Potato Production

 Agronomic/Cropping Practices

 Potato Seed Production

 Organic Potato Production

Environmental Considerations:

 Water Resources

 Soil

 Air Quality

 Climate Change

 Animals

 Plants

 Gene Flow

 Microorganisms

 Biological Diversity

Human Health Considerations:

 Public Health

 Worker Safety

Livestock Health Considerations:

 Livestock Health/Animal Fe ed

Socioeconomic Considerations:

 Domestic Economic Environment

 Trade Economic Environment

APHIS evaluated these raised issues and the submitted documentation. APHIS has also included a discussion of these issues in this E A.
APHIS has analyzed and evaluat ed the issues described in the comments, and has included a discussion of these issues in this EA with citations where appropriate. In general, those commenters opposing the9

petition expressed their disagreement with GE crops; favored longer term safety t esting for Simplot Innate TM W8 potato; and suggested that RNAi technology is not safe for use. Two commenters asked for the public comment period to be extended, and also stated that due to the complexity of the product, an EIS was needed.
Commenters favoring the petition cited health benefits from reduced acrylamide; reduced wastage and crop loss; lengthening of storage periods with less reliance on sprout inhibitors; and reduced use of fungicides to prevent late blight.

2 AFFECTED ENVIRONM ENT

This section includes a review of the prevailing conditions of the human environment that may be impacted by Simplot Innate TM W8 p otato production. Relevant environmental components include the agricultural production area of Simplot Innate TM W8 p otato , physical , environment al, biological resources, human health, animal feed, and socioeconomic resources

.

2.1 Agricultural Production and Agronomic Practices of Potato
Potato is the fourth most important crop in the world in terms of human consumption, following rice, wheat, and maize (corn) ( Arvanitoyannis et al. , 2008 ; Llorente et al. , 2011 ; Zaheer and Akhtar, 2014 )

. Potato is grown in over 100 countries, with world potato production exceeding 300 million metric tons ( Center, 2010 )

. After China, India, Rus sia, and the Ukraine, the U

. S

. is the fifth largest potato producing country ( FAO, 2013 ; Zaheer and Akhtar, 2014 ) , with annual production over the last three years of between 404

- 467 million centum weight (cwt) (centum weight = 100 pounds) , grown on 1.0

- 1.1M acres ( USDA

- NASS, 2013b )

. The Russet Burbank potato cultivar was transformed by Simplot to produce the Simplot Innate TM W8 p otato ( Simplot, 2014 )

. Russet Burbank is a brown, smooth

- skinned, white

- fleshed potato that is high

yielding, has a low sugar content and stores well for long periods of time ( Nevada, 2014 )

. Taste panels rate Russet Burbank highly for flavor ( Nevada, 2014 )

. Originally developed by Luther Burbank in the early 1870s ( PAA, 2013 ) , Russet Burbank is the most popular potato variety in the U

. S

. ( Nevada, 2014 ) , is used primarily for baking , and for processing into French fries and chips ( NPC, 2013 ; Nevada, 2014 ; University, 2014 )

. I n 2012, Russet Burbank was planted on approximately 40% of the acreage devoted to potatoes in the U

. S

. ( University, 2014 ) , especially in the Pacific Northwest and Midwest ( Nevada, 2014 )

. The cultivar’s low sugar content is especially advantageous since high sugar contributes to acrylamide production during cooking, decreased processing quality ( Driskill et al. , 2007 ) , and consistent low sugar content during the storage period ( Nevada, 2014 ; University, 2014 )

. Russet Burbank tolerates the plant disease common scab well ( PAA, 2013 ) but is susceptible to black spot bruise and dehydration ( Nevada, 2014 ) and to pathogens suc h as Fusarium and Verticillium wilts, leafroll and net necrosis, potato virus Y, and late blight ( PAA, 2013 )

. Russet Burbank is sterile and produces only a few white flowers during production ( PAA, 2013 )

. Table 1 summarizes some of the agronomic requirements for this variety.10 

### Table 1

. Agronomic Inputs for Russet Varieties

Russet Varieties
Planting Date April 1 to May 10
Planting Rate 15,000

- 18,000 seed pc or 17

– 23 cwt/A
Row Spacing 34

- 36” between rows
Seed Spacing 10

- 12” within row

Fertilizer For 600 cwt/A yields and optimum soil

test levels:

250 lb N

– 100 lb P 2 O 5 – 330 lb K 2 O per

acre Yield/Plant 2

- 4 lb Yield/Acre 400

- 700 cwt/A

Harvest Date September 1 to October 15

Source: ( PAA, 2013 )

2. 1 .1 Land Use
Potatoes are grown acr oss most of the continental U

. S

. , with six States (Idaho, Washington, Wisconsin, North Dakota, Oregon, and Colorado) accounting for approximately 73% of annual production ( USDA

NASS, 2014d ; 2014b ) (Figure 1)

. Within recent years, land devoted to potato production has shifted from the East and Midwest to the Pacific Northwest. This shift has resulted from a number of factors, in cluding improvements in the U

. S

. transportation system, the relative decline in consumption of fresh potatoes coupled with advantages associated with proces sing potatoes in the Northwest such as lower taxes, lower power and labor costs, more favorable weather, and available arable land ( Guenther, 2010a )

. The largest potato

- g rowing region by far in the U

. S

. is the Snake River Plain of southern Idaho, a major agricultural area where water is available f or irrigation and where nearly all the Idaho crop is grown ( Bechins ki et al. , 2001 ; USDA

- NASS, 2012c ) . The second

- largest growing region is the Columbia Basin in Washington and Oregon, where approximately 137,000 acres were harvested in 2010 ( USDA

- NASS, 2012c ) . Other important areas (with 2010 harvested acreage in parentheses) are the Red River Valley, which lies betw een the northern borders of North Dakota and Minnesota (63,000); San Luis Valley in south central Colorado (55,200), Aroostook County in Maine (50,400), and the Central Sands region of Wisconsin (36,700) ( USDA

- NASS, 2012c )

. Simplot InnateTM W8 p otato may be grown in any of the U

. S

. potato

- growing regions.11 

### Figure 1

. Po tato Growing Regions of the United States ( USDA

- NASS, 2007 )

Po ta to acres , harvested in the U

. S

. have ranged between 1.0 and 1.5 million acres since 1951, with highs of 1.5 million in 1953, 1966 and 1967 , and lows of 1.0 million in 2008, 2009 and 2010 ( USDA

- NASS, 2012c ) . In most years from 1900 to 1937, more than 3 million acres were harvested, with a high of 3.9 million in 1922 ( USDA

- NASS, 2012c ) . While harvested acreage has declined over the years, total production has increased ( Guenther, 2010b )

. For example, in the 1930s, about 3.5 million acres of potatoes were harvested, whereas by 1985, production had nearly doubled on less than half the acreage of the 1930s, and by 2005, acreage had declined to about 1 million acres, less than 1/3 the 1930s
acreage ( Guenther, 2010b )

. T otal acres of potatoes harvested in 2012, 2013 and 2014 were 1.13, 1.05 and 1.07 million acres, respectively ( USDA

- ERS, 2014 ; USDA

- NASS, 2014b )

. Total annual U

. S

. production has been over 400 million cwt every year since 1990 , with per acre yiel d approximately 407 cwt (Table 2 ), which represents an eightfold increase in y ield per acre since the 1990s ( USDA

- NASS, 2010 )

. Per

- acre yields, which averaged approximately 336 cwt per acre in 2012 , have increased seven

- fold since the early 1900s and have doubled since the early 1960s. For example, in 1901 , approximately 2.95 million acres of potatoes were harvested, producing roughly 125 mil lion cwt , or 46.6 cwt per acre ( USDA

- NASS, 2012c ; 2013a )

. The top ten potato producing states are shown in Table 2 ( USDA

- NASS, 2013c )

. Highest yields are in regions where daytime temperatures exceed 100° F during the hottest part of the growing season, and where nights are cool (about 6 5° F) ( Rosen, 2010d ) , such as in Washington’s Columbia Basin, eastern Oregon, and Idaho.


### Table 2

. Major Potato Production States in 201312 State Production

( 1,000 cwt) Total U

. S

.

Production (percent) Potato Harvest

(acres)

Idaho 131,131 30.2 316,000
Washington 96,000 22.1 160,000

Wisconsin 26,040 6.0 64,000

North Dakota 22,620 5.2 78,000
Oregon 21,582 5.0 39,600

Colorado 20,304 4.7 54,000

Minnesota 17,325 4.0 45,000
Michigan 15,840 3.6 44,000

Maine 15,660 3.6 54,000

California 14,369 3.3 26,500

Sou rce: ( USDA

- NASS, 2014b )
Most potatoes are harvested in July through October. Fall crops have increased because of demand for processing ( Guenther, 2010b )

. Harvested potatoes are either used for food (~93%), feed (<1%), industrial purposes (<1%) or as “seed” for planting (5%) ( NPC, 2012 ; USDA

- NASS, 2013c ; 2014a )

. Usage is partially dependent on a variety of characteristics related t o tuber quality. Only about one

- quarter of U

. S

. potatoes are consumed fresh ( USDA

- NASS, 2014b ) , while approximat ely 35 % of annual output is processed into frozen products (such as frozen fries and wedges), chips, dehydrated potato and starch ( 25 %) , or canned potatoes (0.4%), and 6% is replanted as seed potato. Americans ea t, on average, approximately 115 lb s. of potatoes per person per year , of which about two thirds is consumed as processed potato products ( USDA

- ERS, 2010 )

. Raw potato waste products (peels, out

- of

- specification raw potatoes, or other non

- processed raw potato products) and processed discards ( French fries, hash brown s , etc.) are routinely incorporated into feed ratio ns at livestock feedlot operations ( Simplot, 2014 )

.

2. 1 .2 General Agronomic Practices
USDA classifies potato production by season, according to the period when the largest supplies are har vested . Winter, spring and summer potatoes are harvested while the vines are still green and the tubers comparatively immature. These potatoes go directly from the field to fre sh markets or into pr ocessing. Fall potatoes are usually harvested when the vines and tubers are mature. M ature potatoes are usually higher in dry matter, which makes them better for most processing , and also have tougher skins, which makes them easier to handle ( Johnson, 2010 ) . A large percentage of the fall crop is stored for13

processing and fresh market through the winter, spring and summer months. Many modern storage fac ilities are equipped with temperature, humidity, and forced

- air ventilation control. Capacity can range from 500 tons to ov er 20,000 tons ( Olsen, 2010 )

. Proper water managemen t is integral to obtaining optimum quality and yield since potatoes are more sensitive to wat er stress than some other crops. Potatoes have a relatively shallow root

- zone depth, and are frequently grown on soils with only fair water

- holding capacities ( King and Stark, No Date )

. The easternm ost regions of the U

. S

. generally receive enough ra infall in order to produce good quality and yield of potatoes, whereas the western part of the country typically relies on some form of irrigation ( Shock, 2010 ) . Specific guidelines for irrigation depend on geographic region and factors typical of that region such as temperature, relative humidity, and day length. Water requirements also vary to some degree with cultivar. Most pot ato

- growing regions require between 18 and 36 in. of water to produce an optimum crop. Enough moisture to keep plant stomata open during the hottest part of the day is critical ( Shock, 2010 )

. In regions where rainfall is the primary source of water, growers may increase water use efficiency by avoiding steeply sloping fields for planting, by preparing the soil so that infiltration of water is increased, and also by making ridges in the furrows to mitigate the amount of water running off the field ( Shock, 2010 )

. Timing of water application and amount of water delivered are important to pot ato production. Some physical defects, such as growth cracks, hollow heart , black spot, and knobby tubers, are directly related to amount and distribution of water during the growing season. Excessive water may result in yield reduction and disease s such as Rhizoctonia stem canker , scab, and tuber late blight ( DEFRA, 2006 ; Shock, 2010 ; King and Stark, No Date ) . Too little water at the time of tuber initiation can lead to a reduced number of tubers ( DEFRA, 2006 )

. Daily water needs increase from emergence of plants to approximately two weeks after row closure, but then decline rapidly after onset of vine maturation ( DEFRA, 2006 ; Shock, 2010 ) . Potatoes need more water during tuber initiation and early tuber development. At harvest, soil water content is also important to reduce mechanical damage to tubers which are frequently associated with dehydration such as black spot bruise, and excess water such as shatter bruise and thumbnail cracking ( DEFRA, 2006 ; King and Stark, No Date )

.
P otato Breeding The tetraploid nature of commercial potato varieties is a significant impediment to potato breeding , as well as biological factors su ch as inbreeding depre ssion, and cytoplasmic and nuclear sterility ( Hoopes and Plaisted, 1987 ; Arvanitoyannis et al. , 2008 )

. Due to complex chromosome segregation ratios, polyploid crops are inherently more difficult to breed. Furthermore, vegetatively propagated crops like potato are often poor seed producers due to partial or full sterility. For seed

- propagated crops, like corn or soybean, trait developers ofte n create a single elite event and then backcross that elite event into a wide range of elite germplasm. This is not possible in potato , due to limitations in conventional breeding

. Each parent variety must be independently transformed to achieve the desi red phenotype in that variety ( USDA

- APHIS, 2014b )

. I f a sing le variety was transformed, it c ould take decades to move these new traits into the other commercial varieties by conventional breeding, and e ven then, it would14

be difficult to reconstitute the desirable characteristics of the original variety ( Llorente et al. , 2011 ; Simplot, 2014 )

. Because maintenance of a vegetatively propagated, disease

- and insect

- free genetic stock is difficult, much of the genetic base is kept as true seed populations ( Spooner, 2010 )

. Cultivation
Potatoes typically require h igh levels of soil cultivation ( Hopkins et al. , 2004 ) , which helps with weed control, aeration, shaping beds, maintaining proper seed depth and establishing irrigation furrows ( Bechinski et al. , 2001 ; Sieczka, 2010 ) . Potato production is generally not conducive to maintaining healthy soil conditions , because of intensive tillage, minimal crop residues left on the field , heavy field traffic and long periods of soi l being left bare ( Hopkins, 2010 ) . In the Northwest, potato fields are typically tilled both befor e and after the season ( Hopkins et al. , 2004 )

. In the Red River Valley, between North Dakota and Minnesota, a common practice just before planting is to plow once in the fall, till two or more times during the winter, and disc the field in the spring ( USDA, 2000 )

. Cover Crops In potato production, a fall cover crop is frequently planted in order to reduce erosion from fields ( Sexton, 2010 )

. Subsequent to mowing the cover crop , the residues may be left on the field to minimize wind erosion ( Rosen, 2010b )

. Another method of reduc ing erosion as well as mitigate disease pressure is to till green manure crops (crops which are left to decompose on fields to provide cover or mulch for a subsequent crop) into the soil prior to planting ( Hopkins et al. , 2004 )

. G rowers in Florida use Sudan grass as a cover crop to provide nitrogen prio r to potato planting ( Mossler and Hutchinson, 2011 )

. Growing cover crops can also increase yield of the subsequent cash crop ( University, 2013 )

. Crop Rotation

One of the challenges that growers face is the high short

- term economic demand for potatoes to be grown continuously , partly because of the investment that is put into the specialized equipment used in potato growing, and because potatoes represent the highest po tential gross return per acre ( Hopkins et al. , 2004 )

. C ontinuous cropping and short rotations of this crop with other crops increases the risk of insect , disease, and nematode pressure ; decrease s soil nutrient levels ; and increase s eros ion potential ( Delahaut, 2000 ; Hall et al. , 2000 ; Bennett and O'Rourke, 2002 ; Larkin, 2003 ; Hopkins et al. , 2004 )

. Lower microbial biomass occurs in fields where continuous cropping is practiced, compared to fields where crops are rotated ( Larkin, 2003 )

. Therefore, frequent rotation of other crops with potatoes is recommended ( Hopkins, 2010 ; University, 2013 ) in order to increase potato yield and to reduce insect and disease pressure, as well as to reduce the population density of weeds. Farmers are also advised to avoid planting potatoes near fields where potatoes were planted the previous year. Rotation crops vary
w ith geographical region: for example, in Idaho, potatoes are rotated with small grains, sugar beets, alfalfa, dry beans and corn ( Hopkins et al. , 2004 ) ; with grains in the Red River Valley in North Dakota and Minnesota ( USDA, 2000 ) ; with malting barley in the San Luis Valley in Colorado ( McDonald et al. , 2003 ) ; and corn, small grains, legumes and green manure crops in Wisconsin ( Delahaut, 2000 )

. Insect Control15

The potato crop is intensively managed with integrated pest management (IPM) to control a variety of insect s and disease s ( Johnson, 2007 )

. More than 150 species of insects may damage potatoes, most of which cause only minor economic injury . However, several species cause more damage through feeding on foliage, tub ers, or roots, or by transmitting disease pa thogens to the plant. While major insect pests vary within production regions, the most serious overall is the Colorado pot ato beetle. In the eastern US , leafhoppers can also cause yield loss to plants before plants present any visual symptoms of feeding damage; several leafhopper species are serious problems because they vector phytoplasmas ( Radcliffe, 2010 )

. Aphid

- transmitted diseases cause greater economic losses than all other insect damage combined together. At least 9 potato viruses are transmitted via aphids , of which potato leaf roll virus (PLRV), vectored primarily by green peach aphid, and potato Y v irus (PVY), vectored by potato aphid, pea aphid, melon aphid, buckthorn

- potato aphid, soybean aphid, and bird cherry

- oat aphid , are prevalent in potato crops ( Radcliffe, 2010 ; Rondon, 20 12 )

. Occasional pests include armyworm, loopers, cutworms , and spider mites ( Rondon, 2012 )

. Some soil insects can cause a decrease in quality of tubers, but generally cause little decrease in yield. The m ost important of these are wireworms, the larval stage of elaterid beetles ( Bechinski et al. , 2001 ) , particularly if fields are laden with sod sometime before planting ( Roberts and Cartwright, No Date )

. Growers may mitigate insect press ure by avoiding planting on fields nearby cornfields since European corn borer may also infest potato ( University, 2013 )

. Insect pests in stored corn include potato tuber moth, Phthorimaea operculella, and seed corn maggot, Delia platura ( Rondon, 2012 )

. Table 3 lists the major insect pests of potato.


### Table 3

. Major Insect Pests of Potato

Common Name Scientific Name
Colorado potato beetle Leptinotarsa decemlineata
Green peach aphid Myzus persicae

Wireworms Limonius californicus, L. canu, Ctenicera pruinera
Potato leafhopper Emposasca fabae
Pea aphid Acyrthosiphon pisum
Soybean aphid Aphis glycine
Thrips Franklinella spp., Thrips spp.

Flea beetle Epitrix spp.
European cornborer Ostrinia nubilalis
Potato psyllid Bactericera (Paratrioza) cockerelli

Potato Tuber worm or Tuber Moth Phthorimaea operculella16 Sources: ( Radcliffe, 2010 ; Rondon, 2012 ; Roberts and Cartwright, No Date )

Disease Control

Potato d iseases can be caused by viruses, viroids, phytoplasmas, and most importantly, by bacteria and fungi

. Infection can occur when cutting potatoes into seed pieces prior to planting , in which a disease organism present in the seed potato is transmitted to the resulting potato plant. The cut surfaces of the seed pieces, until they are suberized, are open woun ds that provide a route of entry for pathogens ( Davidson, 2010 )

. Potatoes can become infected with a number of viruses (e.g. potato leafroll virus, and potato viruses A, M, X and Y); however, IPM options for virus pests are li mited to insecticidal control of their insect vectors and planting of resistant varieties ( Arif et al. , 2012 ; USDA

- APHIS, 2014b )

. There are several factors to consider in controlling potato diseases, including the part of the plant being attacked, pathogen transmission mechanism, and environmental conditions . Table 4 lists the major diseases of potato. Some of these diseases are more common while plants are in the field, while others only emerge during storage ( Bechinski et al. , 2001 )

. Growers may plant disease

- resistant cultivars, use certified seed, spray fungicides, and rotate potato with other crops in order to mitigate disease pressure ( Johnson et al. , 2010 ; Hollingsworth, No D ate )

. 

### Table 4

. Major D iseases of Potato

Common Name Scientific Name

Bacteria

Aster Yellows MLO Member of Acholeplasmataceae

Bacterial ringrot Corynebactium sepedonicum

Bacterial brown rot Ralstonia solanacearum

Bacterial soft rot Pectobacterium
carotovorum
Blackleg Erwinia carotovora

Golden nematodes Globodera rostochiensis

Potato tuber rot Ditylenchus destructor

Root knot Meloidogyne spp.

Columbia root knot Meloidogyne chitwoodi

Root lesion Pratylenchus penetrans
Viruses

Potato Leafroll Virus Luteovirus17 Common Name Scientific Name

Potato Spindle Tuber Viroid Member of Pospiviridae

Potato Virus A,M, X, Y Members of Potyviridae, Carlavirus,

Tobacco Rattle Virus Tobravirus Fungi

Late blight Phytoph th ora infestans

Pink rot Phytophthora erythroseptica
Early dying Verticillium spp.

Sclerotinia stalk rot or white mold Sclerotinia sclerotiorum

Canker or black scurf Rhizoctonia solani

Scab Streptomyces scabies

Dry rot Fusarium spp.

Fusarium wilt Fusarium solani var eumartii, Fusarium oxysporum

Water or shell rot Pythium ultimum

Early blight Alternaria solani
Gray mold Botrytis cinerea

Black dot Colletotrichum coccodes

Ring rot Clavibacter michiganensis subsp. Sepedonicus

Powdery scab Spongospora subterranea

Silver scurf Helminthosporium solani

Wart Synchytrium endobioticum

Nematodes

Golden nematodes Globodera rostochiensis

Potato tuber rot Ditylenchus destructor18 Common Name Scientific Name

Root knot Meloidogyne spp.

Columbia root knot Meloidogyne chitwoodi

Root lesion Pratylenchus penetrans

Sources: ( Johnson et al. , 2010 ; Roberts and Cartwright, No Date )

Late B light

The disease known as l ate blight of potato is caused by an o omycete pathogen , Phytoph th ora infestans ( C ooke et al. , 2012 )

. Late blight is renowned in history as the causative agent of the Irish potato famine during the 1840s, which resulted in widespread potato crop failure and famine, and waves of migration from Ireland ( Herman and Williams, 2012 ) . Wit hin the U

. S

. , the pathogen was first reported in 1843, in New York City and Philadelphia ( Nowicki et al. , 2012 ; Akino et al. , 2014 ) , and became widespread throughout the rest of the world by 1845 ( Fry, 2008 )

. Late blight is prevalent in many areas of the U

. S

. and is now found in near ly every potato state ( Simplot, 2014 ) . For example, in Idaho, the top

- producing potato state, late blight has occurred in nearly every commercial potato field over the last 20 years, resulting in severe losses duri ng some of those years ( Miller et al. , 2006 )

. Worldwide, late blight is a very destructive disease capable of destroying a potato crop in only a few days ( Vleeshouwers et al. , 2011 ) , and outbreaks frequently turn into epidemics ( Fry, 2008 ) . Its success as a pathogen is due in part to its reproductive cycle and its ability to adapt quickly to resistant plants ( Vleeshouwers et al. , 2011 )

. The late blight pathogen spreads quickly through infected fields, causing widespread foliar necrosis resulting in plant death and significant yield reduction. Infected tubers can

cause lesions and rot that destroys entire lots in storage ( Simplot, 2014 )

. Bec ause th e primary source of infection is infested potato tubers, potato is generally the main crop affected by late blight ( McGrath, 2010 ) . However, the pathogen will also infect other solanaceous plants and crops such as tomato and eggplant ( Akino et al. , 2014 ) . A gricultural areas where potato and tomato are grown near each other, and grown all year round are at greater risk of developing late blight ( Nowicki et al. , 2012 )

. Phytoph th ora infestans is capable of reproducing either sexually or asexually ( Nowicki et al. , 2012 ) . Fry et al. ( 1993 ) notes that the diversity of genotypes resulting from sexual reproduction can fuel more virulence in populations. Asexual reproduction o f P. infestans can be viewed as a mechanism to greatly increase population growth under favorable environmental conditions ( Fry, 2008 ) , and may drive epidemics ( Nowicki et al. , 2012 ) . O ccurrence/predominance of only 1 mating type in a geographic area suggests that asexual reproduction is the only means of propagation in these areas ( Fry et al. , 1993 )

. Population displacement of “old” populations or sexual recombination within the aggressive “new” population has resulted in severe outbreaks worldwide in recent decades ( Chowdappa et al. , 2014 )

. These “new” populations have been associated with fungicide resistance or an ability to overcome host resistance ( Chowdappa et al. , 2014 )

. P. infestans usually overwinters on potato tubers or on one of its alternate hosts, tomatoes in greenhouses, so that the annual disease cycle may be difficult to break ( Bush et al. , 2012 ) . Infected tubers from the previous season pro duce infected seedlings, a significant source of late blight inoculum. In the development of late blight disease on susceptible plants, P. infestans produces thousands of19

sporangia per lesion ( Nowicki et al. , 2012 ) , each of which can, in turn, produce as many as 300,000 sporangia per day ( Fry and Goodwin, 1997 ) . Once a potato plant is infected, late blight spores can be propagat ed for as long as the foliage is still green ( Bohl et al. , 2003 )

. Dispersal is by wind ( Bohl et al. , 2003 ; McGrath, 2010 ) , frequently over long distance s of up to 30 miles , as well as dispersal by infected tubers moved by humans and animals ( Aylor et al. , 2001 ; Bohl et al. , 2003 ; Miller et al. , 2006 ; Nowicki et al. , 2012 ; Akino et al. , 2014 ; Rowe et al. , No Date )

. Dispersal during cloudy days or at night helps protect spores from the lethal effects of UV radiation ( McGrath, 2010 ) . Wind and rain may dislodge spores on infected plants, and winds may carry them into potato fields as far away as 10 miles, thereby initiating another disease cycle ( Rowe et al. , No Date )

. Spores may remain viable for up to a week ( McGrath, 2010 ; Nowicki et al. , 2012 )

. Spore and infected tuber movement is critical to epidemic development ( Fall et al. , 2014 )

. Depending on environmental conditions, regeneration time can be short, in as little as 5

- 7 days ( Nowicki et al. , 2012 )

. Late blight disease has several foliar symptoms in potato , including wilting, damping

- off, and chlorosis ( Akino et al. , 2014 ) . The pathogen produces characteristic circular or irregular leaf lesions which are surrounded by a light yellowish

- green margin which merges with healthy tissue. Lesions typically develop on lower leaves first because it is more humid closer to the soil , and on leaf edges or petioles where dew remains longer ( Kirk et al. , 2004 )

. Symptoms typically appear within 5 to 7 days after infection ( Bohl et al. , 2003 ) , and the disease cycle of colonization of uninfected plants, sporulation, and dispersal of spores to new plants can take place in less than five days ( Fry and G oodwin, 1997 ) . Once a potato field is infected, P. infestans has the potential to completely destroy the plants in the field in about a week ( Nowicki et al. , 2012 )

. Lesions on tubers are shallow, sunken, copper y
- brown dry rot spots which spread in an irregular pattern from the exterior of the tuber to the first 1/8 to 1⁄2 inch of the underlying flesh . The flesh beneath lesions is granular and tan to copper brown ( Rowe et al. , No Date ) . Lesion formation may be slowed under cool and dry storage conditions, but if storage is prolonged, lesions appear sunken and dried ( Rowe et al. , No Date )

. L esions quickly get bigger and their color deepens to a range of dark brown to purple

- black ( Rowe et al. , No Date )

. Infested tubers are also vulnerable to attack from bacteria, fungi, and other pathogens, which deteriorate tubers further ( Kirk et al. , 2004 ; Schumann and D'Arcy, 2005 ; Bush et al. , 2012 ; Rowe et al. , No Date )

. Reportedly, late blight lesions on tuber s are less obvious on some cultivars, including the Russet varieties ( Kirk et al. , 2004 ) , which may make diagnosis more difficult.
Other parts of the potato plant also deteriorate when infected with late blight . When stems are infected, they turn brown or black ( Rowe et al. , No Date ) , and all of the tissue above the stem dies ( McGrath, 2010 )

. Vine death may occur very quickly under favorable conditions ( Rowe et al. , No Date )

. Even flowers show symptoms of infection ( Porter et al. , 2004 )

. Besides lesions, there are several other diagnostic characters for late blight infection in potato fields

. The appearance of white, velvety growth on foliage is characteristic of late blight ( Kirk et al. , 2004 )

. In a field hard hit with late blight, dying plants emit a distinctive odor ( Kirk et al. , 2004 )

. When tomato is infected, symptoms are similar ( Schumann and D'Arcy, 2005 )

. Generally, the g enotypes of P. infestans attacking tomato appear to be less virulent than those infecting potato ( McGrath, 2010 ) ,20

and those strains specialized to attack tomatoes may be less pathogenic to potato than potato

- adapted genotypes ( Fry, 2008 )

.
Potato c rop vulnerability to late blight is influenced by factors such as weather ( Sparks et al. , 2014 ) and agronomic practices. Cool, cloudy, wet or humid weather with soil temperatures < 65 F

. favors disease development ( Bohl et al. , 2003 ; Kirk et al. , 2004 ; Miller et al. , 2006 ; Gigot et al. , 2009 ; Bush et al. , 2012 ; Herman and Williams, 2012 ; Majeed et al. , 2014 ; Rowe et al. , No Date )

. During cultivation of a potato crop, additional measures may be taken to minimize the development of late blight. These include water management such that moisture in the fields, particularly standing water, is minimized, by scheduling irrigations at times such that the foliage has the time to dry out before the next water application, and early enough in the day so that dew formation is decreased ( Bohl et al. , 2003 ; Miller et al. , 2006 )

. Irrigating fields after rains or humid weather may also raise probability of disease development because water may dislodge spores from plants or soil and move to other, uninfected locations ( Miller et al. , 2006 ; Rowe et al. , No Date ) . In addition, the use of sprinkler irrigation may heighten vulnerability to P. infestans due to the po tential for subsequent hea vy dew formation ( Miller et al. , 2006 )

. Operation of other agricultural machinery and equipment may also physically spread spores ( Miller et al. , 2006 )

. There are several methods described in the literature to prevent late blight development. At present, there are no methods such as labeled fungicides which wil l kill late blight once the plant is infected ( Miller et al. , 2006 ) , so disease prevention is currently crucial for growers

. Most notable is fungicide
treatme nt, which can be highly protective, especially under “late blight weather conditions” ( Cooke et al. , 2011 ; Nowicki et al. , 2012 ; Rowe et al. , No Date )

. Because fungicides operate as protectants rather than eradicators of the disease, they need to be a p plied prior to the expected timing for disease development. Forecasts of predicted disease assist growers with fungicide spray timing, and are available through disease forecast systems ( Bohl et al. , 2003 ) . Typically, growers apply fungicides about two weeks before predicted infection of fields in their geographic area ( Miller et al. , 2006 ) , and frequently need to be reapplied on a regular basis to achieve full protection ( Wiik, 2014 )

. For example, growers in northern Europe spray fungicides 10

- 15 times per season in order to control late blight ( Jones et al. , 2014 ) . In the U

. S

. , m ore than 2000 tons of fungicide were sprayed in 2001. Such frequent chemical treatments impose a heavy economic burden o n growers ( Fry, 2008 ) . Some sources (e.g., ( Miller et al. , 2006 ) ) recommend alternating fungicides by different chemical class to achieve greater protection. Recent research indicates that systemic fungicides perform better than do contact fungicides ( Majeed et al. , 2014 )

. Crop rotation of potato with a second crop may break the cycle of infection ( Miller et al. , 2006 ; Cooke et al. , 2011 ) , except in some northern states where P. infestans spores cannot overwinter ( McGrath, 2010 )



### . Cultural practices such as land sharing and shorter rotation periods between potato crops may result in increased survival of volunteer potato plants and tubers which may be infected ( Gigot et al. , 2009 )

. Volunteer potatoes and tomatoes are a potential source of P. infestans inoculum ( Eberlein et al. , 1998 ; Miller et al. , 2006 ; Everman and Long, 2010 ; Cooke et al. , 2011 ; Rowe et al. , No Date )

. Spores may persist in overwintered volunteer potato plants, and in the soil for two months under typical field conditions ( Cooke et al. , 2011 )

. Volunteers typically augment and accelerate epidemics of P. infestans21

rather than initiate them ( Cooke et al. , 2011 ) . In areas with warmer winter temperatures, spores may survive overwintering ( Gigot et al. , 2009 ; McGrath, 2010 ; Cooke et al. , 2011 ) , and rain can wash spores down plants into the soil ( McGrath, 2010 ) , where they can survive until the next year’s growing season ( Cooke et al. , 2011 ) . This source of inoculum can be remedied by monitoring for and destroying any volunteer potatoes and tomatoes ( McGrath, 2010 ; Rowe et al. , No Date )

.
Because P. infestans is capable of infecting alternative hosts such as such as black nightshade, Solanum nigrum , bittersweet, S. dulcamara , and hairy nigh tshade, S. physafolium ( Gronberg et al. , 2012 ) , m anagement of solanaceous weeds may help to control late blight ( McGrath, 2010 ) . In addition to serving as reservoirs for infection, weeds may also contribute to infection in potato fields by restricting air movement within the potato canopy ( Kirk et al. , 2004 ) , and impeding adequate spray coverage with fungicides ( Miller et al. , 2006 )

. Growers frequently discard defective potatoes into cull piles ( Miller et al. , 2006 ; Johnson, 2010 ; Rowe et al. , No Date ) , which are another major source of P.infestans infection

. In some geographic areas, if cull piles are small enough, the tubers wil l freeze and any infection will be killed ( Kirk et al. , 2004 )

. Tuber d ecomposition in cull piles can be hastened by covering with plastic tarps to increase temperatures within the piles ( Kirk et al. , 2004 )

.
An other important source of late blight disease is i nfested seed tubers ( Kirk et al. , 2004 ; Miller et al. , 2006 ; Cooke et a l. , 2011 ) . Usually, tubers are infected in the field when being handled ( Cooke et al. , 2011 ) . To reduce the risk of late blight affecting potato crops, growers are advised to plant only certified seed potatoes ( Kirk et al. , 2004 ; Johnson et al. , 2010 ; McGrath, 2010 ; Rowe et al. , No Date )

. Seed treatment with an appropriate product labelled for that purpose may also help to reduce chances of infection

. Such treatments do not kill the spores, but decrease infection of seed tubers ( Bohl et al. , 2003 )

. P. infestans has been documented to spread in cut seed, with length of storage correlated with probability of disease spread ( Lambert et al. , 1998 )

. Infection risk can also be minimized by placement position of seed during planting; planting seed deeper is preferred since tubers developing closer to the soil surface are more at risk of infection because of proximity to infected plant parts above the soil ( Bohl et al. , 2003 )

. Growers are also advised to restr ict planting to areas which can be easily sprayed with fungicides, as well as to avoid planting in field locations which are likely to be wetter than usual, such as in low areas which may accumulate standing water, or in the path of a center pivot irrigati on system ( Bohl et al. , 2003 )

. Because excess nitrogen often encourages heavy vine growth and leads to an extended time period for potential late blight infection, growers are frequently advised to avoid any unnecessary fertilizing during the growth cycle ( Miller et al. , 2006 )

. Prudent growers will monitor for late blight symptoms on a regular basis and begin scouting early enough to catch symptoms when they are still small and infection of nearby fields can be mitigated ( Miller et al. , 2006 ) . This is a challenge because such small early lesions are not easily detected visually until 2 to 4 days following infection ( Fry, 2008 ; Nowicki et al. , 2012 )

. Late blight

- prediction models ( sometimes referred to as Decision Support Systems ( DSS) ) which indicate that weather conditions or other factor predispose a geog raphic area to late blight infection, provide growers with cues for when to scout fields more frequently during that time ( Bohl et al. , 2003 )

. In the22

last several years, late outbreak prediction models have been used to attempt to predict favorable weather conditions in specific geographic areas, so that growers may be able to have advance notice in order to decide when to treat fields with fu ngicides ( Herman and Williams, 2012 ) . Decision support systems are not perfect: growers generally do not know if late blight spores are present in their fields, thus, spraying fungicides when weather conditions are ripe for a late blight attack may actually waste resources in the form of chemicals and labor. However, these systems have become popular worldwide for forecasting potential late blight risk ( Fall et al. , 2014 )

. Harvest is a sensitive time period for spread of late blight ( Rowe et al. , No Date ) . Sources vary in

re commendations of how long be fore harvest to kill vines, approximately 2

- 3 weeks beforehand ( Johnson et al. , 2010 ; Rowe et al. , No Date ) , while Olsen et al. ( 2005 ) states that there is some flexibility in timing of vine kill . Growers are advised to avoid harvesting during periods of wet weather ( Bohl et al. , 2003 ; Miller et al. , 2006 ) or when tuber pulp temperatures exceed 65oF , since late blight and other pathogens are more active in warmer temperatures ( Bohl et al. , 2003 )

. The use of resistant cultivars is also an important option ( Johnson et al. , 2010 ) , which should lead to increased yield

. However, most popular potato cultivars on market are not highly resistant ( Fry, 2008 )

. Development of late blight resistant cultivars is an important step toward protection of potato from this de vastating disease. Historically, traditional breeding programs have been used toward this aim, and are slow and inefficient ( Vleeshouwers et al. , 2011 ) . Because of its adaptability, P. infestans has evolved so that resistance genes have been rapidly overcome by new P. infestans races ( Jones et al. , 2014 ) . In addition, traditional crop breeding may unintentionally break up favorable combinations of other alleles or introduce other deleterious alleles of genes linked to disease resista nce ( Jones et al. , 2014 )

. A benefit of p lants with late blight resistance genes is that fields may require less frequent spraying with fungicides, which wil l reduce the costs and associated environmental impacts substantially ( Jones et al. , 2014 )

. Other p athogenic microorganisms which are associated with diseases of potatoes, is discussed in Section 2.1.2, General Agronomic Practices, Disease Control.
Weed Management Weeds pose a management issue for growers, potentially causing a significant loss in yield by outcompeting potatoes for nutrients, water and sunlight. Tillage and herbici de usage can help control weeds ( Delahaut, 2000 ; Hutchinson, 2010 ) , although tillage can also damage potato plants and reduce yields. Common weeds in potato fields fall into three main classes: annual broadleaf plants , which are the easiest to control, with the exception of nightshade; annual grasses, which may germinate later than most broadleaf annuals; and perennials, which are the most difficult to control ( Hutchinson, 2010 ; University, 2013 )

. Major weed species in potato fields are noted in Table 5 . In addition to competition with potato plants for resources, weeds are detrimental to the crop due to potential penetration of potato tubers by weed roots, causing a severe reduction in crop quality ( Hutchinson, 2010 )

. 

### Table 5

. Major Weeds of Potato

Broadleaf Annuals Annual Grasses Perennials23 Hairy nightshade ( Solanum sarrachoides )
Common lambsquarters ( Chenopodium album )
Redroot pigweed ( Amaranthus retroflexus )
Ragweed ( Ambrosia artemisiifolia )
Kochia ( Kochia scoparia )
Pennsylvania smartweed ( Polygonum pennsylvanicum ) Barnyardgrass ( Echinochloa

crus

- galli )
Foxtail ( Setaria spp.)
Wild oat ( Avena fatua )
Fall panicum ( Panicum dichotomiflorum ) Nutsedges ( Cyperus spp.)
Quackgrass ( Elytrigia repens )
Canada thistle ( Cirsium

arvense )

Source: ( Hutchinson, 2010 )
In order to mitigat e weed problems, g rowers should avoid planting potatoes on fields with heavy infestations of weeds. Most growers also scout their fields to assess the need for herbicides, and choose rotational crops that compete successfully with weeds ( Bechinski et al. , 2001 )

. Commonly used herbicides are metribuzin, S

- ethyl dipropylcarbamothioate ( EPTC ) , and metolochlor ( USDA, 2000 ; Bechinski et al. , 2001 ; McDonald et al. , 2003 )

. Growers may also rotate herbicide use according to chemical class in order to avoid or delay the development of weed resistance ( Bechinski et al. , 2001 )

. Volunteer Potatoes
Volunteer potatoes are tubers that are le ft in fields after a harvest , which compete with rotational crops for sunlight, water, and essential nutrients , and then compete with a subsequent potato crop

. In addition to becoming weeds, v olunteer potatoes can also be hosts for disease s such as late blight, potato leaf roll, and virus Y ( Eberlein et al. , 19 98 ; Boydston and Williams, 2005 ) . Several herbicides can be used for the control of volu nteer potato plants ( Boydston and Williams, 2005 ; Everman and Long, 2010 )

. Other control measures may include p ost

- harve st grazing and rotation to crops competitive with the volunteers ( Eberlein et al. , 1998 )

. In general, potato is a poor colonizer in wild ecosystems. Outside agricultural fields, volunteer potato seedlings cannot compete well with other plants, and, therefore, are unlikely to establish themselves. During transportation and processing, there is a possibility of tubers being released, but there is little probability of successful establishment ( OECD, 1997 )

. Organic Potatoes To bear a certified organic label, farms grossing more than $5,000/year in revenues must be certifie d by a USDA National Organic Program (NOP)

- accredited certifying agency. Certifying agencies also have specific cultural requirements with regard to field selection (e.g., fields cannot have been treated with prohibited chemicals for 3 years before harves t of a certified organic crop, and there must be sufficient buffer zones between certified organic crops and conventionally grown crops in order to reduce24

potential contamination between the two such as via pollination) ( University, 2013 )

. There are other requirements and recommended practices for organic potato production ( see, e.g., ( Moore and Olsen, No Date ) ) for organic potato production in Idaho, and ( Hollingsworth, No Date ) for organic potato production in California.

In terms of U

. S

. organic potato production, measured in cwt /year , the leading states are Washington (>600,000) , Colorado (>500,000) , California (>400,000) , Oregon (>300,000) , Idaho (>200,000) , and much lesser amounts from Maine (>25,000) , Wisconsin (>23,000) , Ohio (>17,000), and Vermont (>7,000) ( USDA

- NASS, 2008 )

. In terms of sales/year, the l eading states are California (>$10 million), Colorado (>$6 million), Washington (>$4 million), Oregon (>$3 million), and Idaho and Maine (each state, >$1 million) ( USDA

- NASS, 2008 )

. As discussed in Section 2.5 .1, Domestic Economic Environment, organic potatoes command a premium price compared to conventionally grown potatoes.

Potato Seed Produc tion

Potatoes are vegetatively propagated by planting tubers or seed pieces ( Davidson, 2010 ; NSF, 2011 ) . In 2012, approximately 6 % of the 2012 ann ual potato crop wa s used as seed ( NPC, 2012 ) in the form of seed potatoes. Certifi ed seed potatoes are produced to ensure genetic purity and to reduce disease introduction ( NPC, 2012 )

. Most seed that is sold is l abeled certified seed ( USDA, 2000 ) , which means that certification agency requirements must be met

. These requirements include inspections of fields, storage facilities, and shipping points in order to evaluate whether disease incidence exceeds established thresholds ( Moore and Olsen, No Date )

. The use of good quality seed potatoes is important to successful potato culture. It is recommended that ideal seed size is about two to four ounces, about the size of a golf ball ( Holling sworth, No Date )

. There are 16 potato seed certi ficati on agencies in the US , including one in each major production state ( NPC, 2012 )

. Typically, s eed potatoes are grown in the same areas where potatoes for commercial production are grown, although the areas of maximum seed production sometimes differ from the areas of maximum tuber production . Majo r seed production states in 2013 in order of de cre asing production were Idaho (>33,000 acres planted ), North Dakota, Montana, Maine , Colorado, Wisconsin , Nebraska and Minnesota (>5 ,000 acres harvested) ( USDA

- NASS, 2014c )

. Potato Processing and Storage About 60% of potatoes are processed into frozen commodities such as French fries and shoestring potatoes and dehydrated potatoes ( Driskill et al. , 2007 )

. Typically, frozen and dehydration industries are concentrated in the Northeast, upper Midwest, and Pacific Northwest. Potato chip processers tend to be more evenly distributed throughout the count r y because chips are fragile , and long

- distance shipping is expensive. Therefore, chipping plants tend to be located near heavi ly populated area s ( Guenther, 2010c )

. Long

- term storage is needed for processing operations. Capacities of storage facilities typically range from 500 to >20,000 tons. Most of the tubers are kept in bulk piles, bu t some facilities use box storage. In northern production areas, a large percentage of the potato crop is stored for processing and fresh market uses during the winter, spring, and summer months. Storage facilities are frequently equipped with ventilatio n systems and systems to monitor temperature, relative humidity and carbon dioxide levels. Some storage facilities are refrigerated to cool stored potatoes during w armer spring and25

summer months ( Olsen, 2010 )

. Potatoes kept stored for > 130 days have a tendency to sprout, and are therefore chemically treated to prevent sprout formation ( Kleinkopf, 2010 )

. Prolonged storage can also lead to lowered tuber quality from moisture loss , which can cause tuber surface wrinkling ( Arvanitoyannis et al. , 2008 )

. Tubers for fry processing account for 36% of all U

. S

. potato production, and >50% of the land area for US potato production is planted in Russet Burbank and Ranger Russet ( Zhu et al. , 2014 )

.

2.2 Physical Environment

2. 2 .1 Water Resources
The principal law governing pollution of the nation’s water resources is the Federal Water Pollution Control Act of 1972, better known as the Clean Water Act (CWA). The Act utilizes water quality standards, permitting requirements, and monitoring to prote ct water quality. The EPA sets the standards for water pollution abatement for all waters of the US under the programs contained in the CWA, but, in most cases, gives qualified states the authority to issue and enforce permits. Drinking water is protecte d under the Safe Drinking Water Act of 1974 (Public Law 93

- 523, 42 U.S.C. 300 et seq .).
Surface water in rivers, streams, creeks, lakes, and reservoirs supports everyday life through the provision of water for drinking and other public uses, irrigation, and industry. Surface runoff from rain, snowmelt, or irrigation water can affect surface water quality by depositing sediment, minerals, or contaminants into surface water bodies. Surface runoff is influenced by meteorological factors such as rainfall in tensity and duration, and physical factors such as vegetation, soil type, and topography. Agricultural production, including potatoes, can adversely impact surface water quality, primarily through sedimentation from erosion and nutrient loading from ferti lizers ( US

- EPA, 2005 ; 2009a )

. Nitrogen loss in the form of ammonium and nitrates to surface water can occur as a result of direct runoff, or by infiltration through the root zone, and discharge to surface water by drainage or seepage ( Zebarth et al. , 1999 )

. Groundwater is the water that flows underground and is stored in natural geologic formations called aquifers. It sustains ecosystems by releasing a constant supply of water into wetlands and contributes a

s izeable amount of flow to permanent streams and rivers. Based on 2005 data, the larges t use of groundwater in the US is irrigation, representing approximately 67.2% of all the groundwater pumped each day ( McCray, 2009 ) . In the US , approximately 47% of the population depends on groundwater for its drinking water supply. The EPA defines a sole source aquifer (SSA) as an aquifer that supplies at least 50% of the drinking water consumed in the area overlying the aquifer. An SSA designation is one tool to protect drinking water supplies in areas where there are few or no alternative sources to the groundwater resource. There ar e 77 desi gnated SSAs in the US and it s territories ( US

- EPA, 2011d )

. Crop production has the po tential to impact groundwater in areas with shallow (less than approximately 15 feet deep) water tables through leaching of the nitrates from fertilizers ( Nolan et al. , 2002 ; DEFRA, 2006 )

. Agricul tural production may lead to nitrate contamination of groundwater through leaching associated with high applications of manure or fertilizers or excessive irrigation ( Zebarth et al. , 1999 ; DEFRA, 2006 )

.26

Unlike a point source which is a “discernible, c onfined and discrete conveyance , ” nonpoint source (NPS) pollution comes from many diffuse sources. Rainfall or snowmelt moving over the ground, also known as runoff, picks up and carries away natural and human

- made pollutants, creating NPS pollution . The pollutants may eventually be transported by runoff into lakes, rivers, wetlands, coastal waters and ground waters. Agricultural NPS pollution includes animal wastes, fertilizers, and pes ticides. Surface water may be contaminated by agricultural sediments transported by erosion that may also include pesticides, fertilizers, and sometimes fuel and pathogens. Agricultural practices that introduce contaminants into the groundwater include f ertilizer and pesticide application, spilled oil and gasoline from farm equipment, nitrates, and pathogens from animal manure.

NPS pollution is the leading source of water quality impacts on rivers and lakes, the second largest source of impairments to wet lands, and a major contributor to groundwater contamination ( US

- EPA, 2005 )

. Management practices that contribute to NPS pollution include the type of crop cultivated, plowing and tillage, and the application of pesticides, herbicides, and fertilizers. The primary cause of NPS pollution is increased sedimentation in surface water s following soil erosion ( US

- EPA, 2005 )

. The major contribution to groundwater contamination derives from agricultural areas (nitrogen inputs from fertilizer and manure drai nage and leaching from root

- zone areas due to over

- irrigation; and salts in the form of carbonates, sulfates, and chlorides, from drainage ) and is influenced by regional environmental factors such as precipitation and soil characteristics ( Skaggs et al. , 1993 ; US

- EPA, 2003 ; King and Stark, No Date )

. Nutrients applied in excess of recommended application rates are listed as the second cause of impairment in lakes, reservoirs , and ponds, with agriculture listed as the third most probable source of the impairment ( US

- EPA, 2012b )

. Agricultural pollutants released by soil erosion include sediments, fertilizers, and pesticides that are introduced to area lakes and streams when they are carried off of fields by rain or irrigation waters ( US

EPA, 2005 )

. Increase in sediment loads to surface waters can directly affect fish, aquatic invertebrates, and other wildlife maintenance and survival. It also reduces the amount of light penetration in water which directly affects aquatic plants. Indirectly, soil e rosion

- mediated sedimentation can increase fertilizer runoff, thereby increasing nutrient loading and facilitating higher water turbidity, algal blooms, and oxygen depletion ( Skaggs et al. , 1993 ; US

- EPA, 2005 )

. O ver

- fertilization should be avoided to prevent nutrient leaching into groundwater, risk of ground water pollution with ni trates , and risk of estuary pollution from nitrates and phosphates ( Carroll and Robinson, 2006 )

. Preservation and conservation of water and soil resources must be maximized and non

- point

- source pollution must be minimized ( Carroll and Robinson, 2006 )

. Most of t he potatoes produce d in the US ar e grown under irrigation , including potatoes grown in Idaho, Washington, Oregon, California, and Wisconsin, whereas r ainfall provides adequate moisture for potato crops in the eastern US ( Shock, 2010 ; King and Stark, No Date )

. Potato yield can be reduced by both under

- and over

- irrigating ( King and Stark, No Date )

. Potato processing can contribute to eutrophication of water ( DEFRA, 2006 )

.

2. 2 .2 Soil Quality

Soil consists of so lids (minerals and organic matter), liquids, and gases. This body of inorganic and organic matter is home to a wide variety of fungi, bacteria, and arthropods, as well as the growth27

medium for terrestrial plant life ( USDA

- NRCS, 2004 ) . Soil is characterized by its layers that can be distinguished from the initial parent material due to additi ons, losses, transfers, and transformations of energy and matter ( USDA

- NRCS, 1999 ) . It is further distinguished by its ability to support rooted plants in a natural environment. Soil plays a key role in determining the capacity of a site for biomass vigor and production in terms of physical support, air, water, temperature moderation, protection from toxins, and nutrient availability. Soil s also determine a site’s susceptibility to erosion by wind and water, and flood attenuation capacity.
Soil properties change over time; temperature, pH, soluble salts, amount of organic matter, the carbon

nitrogen ratio, numbers of microorganisms and soil fauna all vary seasonally, as well as over extended periods of time ( USDA

- NRCS, 1999 ) . Soil texture and organic matter levels directly i nfluence its shear strength, nutrient holding capacity, and permeability. Soil taxonomy was established to classify soils according to the relationship between soils and the factors responsible for their character ( USDA

- NRCS, 1999 ) . Soils are organized into four levels of classification, the highest being the soil order. Soils are differentiated based on characteristics such as particle si ze, texture, and color, and classified taxonomically into soil orders based on observable properties such as organic matter content and degree of soil profile development ( USDA

- NRCS, 2010 ) . The Natural Resources Conservation Service (NRCS) maintains soil maps on a county le vel for the entire U

. S

. and its territories.

There are a mu ltitude of organisms associated with soils, ranging from microorganisms to larger organisms, such as worms and insects. The microbial populations of the soil encompass an enormous diversity of bacteria, algae, fungi, protozoa, viruses, and actinomycetes ( filamentou s bacteria) ( Doran et al. , 1996 )

. The extent of the diversity of microorganisms in soil is seen to be critical to the maintenance of soil health and quality. Microorganisms in soil are critical to the maintenance of soil function in both natural and managed agricultural soils because of their involvement in such key processes as soil structure formation; decomposition of organic matter; toxin removal; and the cycling of carbon, nitrogen, phosphorus, and sulfur ( Bruinsma et al. , 2003 )

. In addition, certain microbial orga nisms may contribute to the protection of the root system against soil pathogens ( Garbeva et al. , 2004 )

. Potatoes grow well in a wide range of soils. Optimum soils are deep, loose, and drain well ( Rosen, 2010c )

. Poorly dr ained soils tend to yield poorly shaped tubers and tubers which are susceptible to diseases like tuber rot ( Plissey and Erhardt, 2000 ; Johnson and Sideman, 2006 )

. Sandy soils can also produce high

- quality potatoes, but these soils are more susceptible to wind erosion ( Rosen, 2010b )

. The ability of soil s to retain water is important because the drier soil becomes, the more difficult it is for the crop to pull water from it, and is dependent on soil texture and structure ( DEFRA, 2006 )

. M aintaining organic matter in soil is advisable because it keeps the soil loose and well

- aerated, which in turn, leads to be tter penetration of root structures, and development of tubers , but is a problem in almost all regions where potatoes are grown except for those areas where soils contain muck and peat ( Rosen, 2010a )

. The recommended pH for soils is slightly acidic, which helps reduce incidence of diseases such as scab ( Plissey and Erhardt, 2000 ; Johnson and Sideman, 2006 )

. Maintaining adequate soil conditions in potato fields may be difficult due to crop tillage, low crop residues on soil surfaces, and foot traffic from agricultural workers , which can lead to higher erosion
rates . Erosion mitigation strategies include growing a cover crop and utilizing the subsequent crop plant residues ( Hopkins et al. , 2004 )

. Where potatoes are grown in fields with stones such as in Maine ,28

removal of stones may ease movement of mechanical harvesters, but may also negatively affect tube r yield ( Saini and Grant, 1980 )

. Soil compaction can occur with excessive tillage ( Roberts and Cartwright, No Date ) , continuous cropping, and the use of large agricultural machines and increased pesticide spraying operations. As the number of machinery passes through the fields increases, soil compaction increases, and oxygen diffusion rate to roots decreases, which in turn may le ad to a reduction in tuber size and increased soil erosion ( Saini and Grant, 1980 ) . Compacted soil also reduces the ability of r oots to find water in soil ( DEFRA, 2006 )

.

2. 2 .3 Air Qu ality
The Clean Air Act (CAA) requires the maintenance of National Ambient Air Quality Standards (NAAQS). The NAAQS, developed by the EPA to protect public health, establish limits for six criteria pollutants: ozone (O 3 ), nitrogen dioxide (NO 2 ), carbon monoxide (CO), sulfur dioxide (SO 2 ), lead (Pb), and inhalable particulates (coarse particulate matter [PM] greater than 2.5 micrometers and less than 10 micrometers in diameter [PM 10 ] and fine particles less than 2.5 micrometers in diameter [PM 2.5 ]). The CAA requires states to achieve and maintain the NAAQS within their jurisdiction. Each state may adopt requirements stricter than those of the national standard and each is also required by EPA to prepare a State Implementation Plan (SIP) containing strate gies to achieve and maintain the national standard of air quality within the state. Areas that violate air quality standards are designated as non

- attainment areas for the criteria pollutant(s), whereas areas that comply with air quality standards are des ignated as attainment areas. Non

- attainment areas are typically associated with large metropolitan areas with many mobile (e.g., vehicle) and stationary (e.g., power plants and factories) sources. Other than emissions from mobile sources, crop farming em ission sources are not specifically regulated nationwide under the CAA. The degree to which emissions from farming practices (such as prescribed burning) are allowed are location

- specific within each State Implementation Plan (SIP) ( US

- EPA, 2011d ) . Regulation of agricultural sources within a SIP does not appear to be typical. For example, based on a review of the available plans in Idaho, achievement of air quality standards is focused on managing residential wood burning, vehicle emissions, and facilities such as factories and processing plants ( US

- EPA, 2011a )

. Agricultural production may produce air emissions such as fugitive dust from the disturbance of bare soil from farming activities or wind, vehicle emissions, and emissions associated with fertilizer and pesticide applications . In some agricultural areas, prescribed burning is practiced and results in higher air emission s levels ( US

- EPA, 2011d )

. Ammonia may be lost to the atmosphere via inorganic nitrogenous fertilizers, but occurs mostly from livestock production processes such as manure storage and applicati on. Atmospheric ammonia can then contribute to the eutrophication of surface water and acidification of soil and water ( Zebarth et al. , 1999 )

. The U

. S

. EPA regulates mobile source emissions by reformulated gasoline and automobile pollution control devices ( US

- EPA, 2011d ) . Stricter requirements, such as vapor recovery nozzles on gas pumps, may apply in non

- attainment areas.

2. 2 .4 Climate Change
Climate change represents a statistical change in global climate conditions, including shifts in the frequency of extreme weather. Agriculture is recognized as a direct (e.g., exhaust from equipment) and29

indirect (e.g., agricultural

- related soil disturbance) source of greenhouse gas (GHG) emissions. The EPA has identified carbon dioxide (CO 2 ), methane (CH 4 ), and nitrous oxide (N 2 O) as the most important GHGs contributing to climate change. While each of these gases occurs naturally i n the atmosphere, human activity has significantly increased the concentration of these gases since the beginning of the industrial revolution. The level of human produced gases accelerated even more so after the end of the Second World War, when industri al and consumer consumption expanded greatly. With the advent of the industrial age, there has been a 36% increase in the concentration of CO 2 , 148 % in CH 4 , and 18 % in N 2 O ( US

- EPA, 2012a )

.

Gree nhouse gases vary in their global warming potential (GWP), and the U

. S

. EPA converts all gases to carbon dioxide (CO 2 ) equivalents. For the three greenhouse gases most associated with agriculture, GWPs are as follows: CO 2 = 1, methane (CH 4 ) = 21, and nitrous oxide (N 2 O) = 310 ( US

- EPA, 2012a ) . The U

. S

. EPA classifies dif ferent sources by sector, with the energy sector being the largest contributor of greenhouse gas emiss ions ( US

- EPA, 2012a ) . The agriculture sector, as defined by U

. S

. EP A, represented 6.3 % of total green house gas emissions for the U

. S

. in 20 10 ( US

- EPA, 2012a ) . How ever, this does not include CO 2 emissions and removals from agricultural

- related land use activities such as liming of agricultural soils (which are included in the land use sector) and it does not include emissions of CO 2 and N 2 O from diesel or gasoline

- p owered agricultural equipment (which are included in the energy sector). The primary greenhouse gases contributed by the agriculture sector as defined by U

. S

. EPA are N 2 O and CH 4 . The relative percent contribution to total CO 2 equivalent emissions of the various agricultural sources in 2010 was as follows: agricultural soil management (fertilizer application and other cropping practices that contribute N 2 O), 49 % ; enteric fermentation (primarily methane emissions from cattle), 33 % ; manure management, 16 % ; and rice cultivation, 2%

. Most of the climate change potential from potato production is derived from transportation, packing and processing of potatoes. Emissions from field burning of agricultural residues, the remaining category, were less than 0.1 % of the total ( DEFRA, 2006 ; US

- EPA, 2012a )

.

2.3 Biological Resources
This section provides a summary of the biological environment and includes an overview of animals, plants, microorganisms, and biodiversity associated with potato production . This summary provides the foundation to assess the potential impact to plant and animal communities

.

2. 3 .1 Animal Communities
Animal communities in this discussion include wildlife species and their habitats. Wildlife refers to both native and introduced species of mammals, birds, amphibians, reptiles, invertebrates, and fish or shellfish. Agriculture dominates human uses of land ( Robertson and Swinton, 2005 )

. In 2011, 917 million acres (approximately 47%) of the contiguous 48 states wer e devoted to farming, including crop production, pasture, rangeland, and Conservation Reser ve Program areas ( USDA

- NASS, 2012b )

. How these lands are maintained influences th e function and integrity of ecosystems and the wildlife populations that they support.
A wide array of wildlife species occur within the major potato

- producing U

. S

. states and could possibly be found in potato fields at least intermittently. There are re ports of wildlife feeding on foliage of30

potato, but reports of damage resulting in economic loss are uncommon. This is not surprising considering that the foliage and stems of potato contain toxic glycoalkaloids known to cause illness when consumed ( Sinden, 1987 ) . In 1992 , APHIS Wildlife Services conducted formal appraisals of wildlife damage on 490 acres of potatoes in Wisconsin and did not report any damage or economic loss ( USDA

APHIS, 2013b ) . However, white tailed deer have been reported to damage potatoes in some areas ( Marinette County, 2014 ) and it is well known that wild boar and voles will feed on tubers ( O'Brien, 2005 ; Taylor, 2014 )

. USDA

- APHIS Wildlife Services has also received complaints for damage caused by sandhill cranes ( USDA

- APHIS, 2013b )

. There are numerous insects found in and around potato fields. Some insects and other invertebrates can be beneficial to potato production, providing ser vices such as nutrient cycling and preying on plant pests. M any insects and invertebrates are detrimental to potato crops, including: Colorado potato beetle ( Leptinotarsa decemlineata ), various aphid species including the green peach aphid ( Myzus persicae ), wireworms ( Limonius californicus, L. canus, Ctenicera pruinina ), flea bee tles ( Epitrix sp

. ), European corn borer ( Ostrinia nubilalis ), potato psyllid ( Bactericera (Paratrioza) cockerelli ), tuberworm ( Phthorimaea operculella ), and the potato leafhopper ( Emposasca fabae ) ( Johnson, 2007 ; Simplot, 2013 ; 2014 ) . Nematodes can also be found in potatoes such as the root knot nematodes ( Meloidogyne spp. ), and cyst nematodes ( Globodera pallida ) and ( G. rostochiensis ) ( Hardy, 1996 )

. The potato crop is intensively managed with integrated pest management (IPM) practices to control these insects, nematodes, and several disease pathogens that include fungi, bacteria and viruses ( Johnson, 2007 ) and
to e nhance potato yield. As a result, pesticides, including insecticides, nematicides, and fungicides , are generally part of an IPM strategy to keep losses below economic threshholds ( US

- EPA, 2000 ; Senseman, 2007 ) . Conventional br oad

- spectrum insecticides are potentially toxic to invertebrates and vertebrates. The U

. S

. - EPA requires application control measures for certain Restricted Use insecticides to limit human and environmental exposure. These impacts can affect animal commun ities, with those communities within and in close proximity to potato fields experiencing the greatest impact ( US

- EPA, 2000 ; 2009b )

.

2. 3 .2 Plant Communities
The landscape surrounding a potato field may be bordered by other potato fields, other crops, or may be surrounded by forest, grassland, bodies of water, or built

- up areas. As discussed in Section 2. 1 , most commercial potatoes are grown in large agricultural areas, such as the Snake River Valley in Idaho. Thus, other crops would most frequently make up the surrounding vegetation, although some fields would be bordered by non

- cr op vegetation. Growers may provide buffer zones to reduce or prevent impact to adjacent vegetation. Because potatoes are g rown thro ughout much of the U

. S

. , a wide variety of plants may be found adjacent to the agricultural fields. These plants have the potential to be impacted by agricultural practices, including the use of pesticides, which are regulated by U

. S

. EPA. Aquatic plant communities near agricultural fields may be affected by sedimentation resulting from erosion, or by nutrients leached from fertilizers.
Plants which compete with potato in crop fields are generally regarded as weeds, an d are discussed in Section 2. 1 .2, General Agronomic Practices

. Native or wild plant species related to cultivated potatoes are of interest because of the pot ential for interbreeding through gene flow. By definition, interbreeding between species that result in viable offspring is not common; otherwise the two plants31

would not be classified as different species. Interbreeding can occur to a limited extent bet ween some species under some circumstances. Among the many factors that must be present for hybridization to

occ ur between two species are : 1) the species must occur in the same area and habitat, 2) the flowering periods of the species involved must overl ap, and 3) appropriate pollinat ors must be present ( OECD, 1997 )

. Section 2. 3 .3, Gene Flow and Weediness , discusses this subject. Because Russet Burbank is sterile ( PAA, 2009 ) , there is virtually no chance for gene flow.
Threatened and Endangered Species

Th ere are currently three plants in the genus Solanum on t he U

. S

. Fish and Wildlife Service (US FWS) list of threatened or endangered plant species: Erubia ( S. drymophilum ), found only in Puerto Rico; and popolo ku mai ( S. incompletum ) and Aiakeakua popolo ( S. sandwicense ), both found only in Hawaii ( FWS, 2011 )

.

2. 3 .3 Gene Flow and Weediness

Gene flow is a biological process that facilitates the production of hybrid plants, introgression of novel alleles (i.e., versions of a gene) into a population, and evolution of new plant genotypes. Gene flow to and from an agro

- ecosystem can occur on both spa tial and temporal scales. In general, plant pollen tends to represent the major reproductive method for transmission across geographic areas, while both seed and vegetative propagation tend to promote the movement of genes temporally and spat ial l y

.
The ra te and success of gene flow is dependent on numerous external factors in addition to the donor/recipient plant. General external factors related to pollen

- mediated gene flow include the presence/abundance/distance of sexually

- compatible plant species; ove rlap of flowering phenology between populations; the method of pollination; the biology and amount of pollen produced; and weather conditions, including temperature, wind, and humidity ( Zapiola et al. , 2008 ) . Seed

- mediated gene flow also depends on many factors, including the ab sence/presence/magnitude of s eed dormancy; contribution and participatio n in various dispersal pathways, envir onmental conditions , and events.
Volunteer potatoes arise from overwintered tubers, and can be a weed problem in the following crop. Potatoes have a fairly low frost toleranc e, and tubers planted too shallowly are subj ect to loss by frost. I n temperate climates up to 20% of tubers left in the soil show no dormancy and will sprout the next

season ( Andersson and de Vicente, 2010 )

. However, volunteer potatoes can be easily controlled with cultivation and herbicides and do not persist as weeds for more than one or a few years ( Andersson and de Vicente, 2010 )

. In general, potato has a low propensity for weediness or persistence and is incapable of survival outside of agricultural production ( Holm et al. , 1979 ; Muenscher, 1980 ; Love, 1994 ; OECD, 1997 )

. Gene flow by hybridization is not possible for the Russet Burbank cultivar because it is sterile ( PAA, 2009 ; NSF, 2011 ; Simplot, 2013 ; 2014 )
In general, p ollination of fertile varieties of potato is mostly by bumblebees ( Bombus impatiens ), which have a relatively short flight range (less than three kilometers ) ( OECD, 1997 )

. P ollen dispersal by nectar

seeking pollinators is limited b ecause potato flowers have no nectar. T he honeybee ( Apis mellifera ) and Bombus fervidus are not attracted to them, and wind plays an insignificant role in pollination ( OECD,32

1997 ) . Empirical field testing of out crossing distances in potato show that separations of 20 meters or more are sufficient to prevent outcrossing ( Conner and Dale, 1996 )

. In addition, the effect on pollinators is probably not important since potatoes are cloned

. Based on the relative lack of pollinator importance in potato production, APHIS does not further consider pollin ator issues in this assessment.

For fertile potato varieties , about 80

- 100% of true seed produced is derived from self

- pollination ( Hoopes and Plaisted, 1987 )

. A potential source of volunteers is true potato seed (TPS). TPS is seed produced via pollination, which develops inside small fruiti ng bodies formed on the potato vine. Its major disadvantage is that it segregates for numerous traits because potato is highly heterozygous, and plants arising from TPS typically take longer to establish and set tubers, resulting in lower yield than from seed potatoes ( Pallais, 1987 ; Simplot, 2013 ) . Russet Burbank is fully sterile, precluding any possibility of TPS production. But plants produced from TPS are no weedier than volu nteer plants produced from over wintered tubers and are relatively easy to control in rotational crops

. Potato ( Solanum tuberosum) belongs to the Solanaceae plant family, along with other cultivated crop plants such as tomato ( Solanum lycopersicon ), eggplant ( Solanum melogena ), tobacco ( Nicotiana tabacum ) , and pepper ( Capsicum annuum ) ( OE CD, 1997 )

. S. tuberosum is divided into two subspecies: tuberosum and andigena

. The subspecies Solanum andigena is also a cultivated species, but its cultivation is restricted to Central and South America ( OECD, 1997 )

. While there appears to be minimal, if any, overla p geographically between cultivat ed and wi ld potatoes in the U

. S

. , there is a possibility that a few wild potato plants may be growing near potato fields ( Love, 1994 )

. However, t he potential for hybridization between wild and domesti cated potatoes is extremely unlikely. Approximately 200 species of wild potatoes have been identified ( Hijmans and Spooner, 2001 ) , but only two species grow within U

. S

. borders, the tetraploid species Solanum fendleri (recently reclassified as Solanum stoloniferum ) and the diploid species Solanum jamesii ( Bamberg et al. , 2003 ; Bamberg and del Rio, 2011 )

. In addition to geographic separation , there are several biological barriers to gene transfer such as multiple ploidy levels and endosperm imbalances ( Love, 1994 )

. Hybridization between native and cultivated potatoes has never been reporte d in the U

. S

. , although gene transfer has been accomplished using special laboratory techniques ( L ove, 1994 ; US

- EPA, 2011b )

.

2. 3 .4 Microorganisms
Soil microorganisms play a critical role in soil structure formation, decomposition of organic matter, toxin removal, nutrient cycling, most biochemical soil processes ( Garbeva et al. , 2004 ) and ma intenance of soil structure and composition ( Rosen, 2010b )

. Compared to soil

- supporting crops, fallow soil has the lowest microbial mass and diversity ( Larkin, 2003 ) . Microorganisms suppress soil

- borne plant diseases and promote plant growth ( Doran et al. , 1996 ; Inceoglu et al. , 2013 )

. The main factors affecting microbial population size and diversity include soil type (texture, structure, organic matter, aggregate stability, pH, and nutrient content), plant type (providers of specific carbon and energy sources into th e soil), and agricultural management practices (crop rotation, tillage, irrigation and herbicide and fertilizer application) ( Garbeva et al. , 2004 ; Rosen, 2010a )

. Crop type also may play an important role in the type of soil microorganisms in soils ( Larkin, 2003 )

. Plant roots, including those of potato , release a variety of compounds into the soil creating a unique environment for microorganisms in the rhizosphere , whereby microorganisms may be attracted to and stimulated by the roots ( Inceoglu et al. , 2013 )

. Microbial33

diversity in the rhizosphere may be extensive and differs from the microbial community in the bulk soil ( Garbeva et al. , 2004 )

. Larkin ( 2006 ) investigated th e effect of potato production on soil microbial communities over a period of three years. A two

- year rotation period appears to control soil

- borne disease. Potato soil microbial populations were lower than for several other crops, including canola , barley, and corn. Use of rotations also appeared to reduce the incidence and severity of black scurf and t he number of misshapen tubers

. Larkin ( 2006 ) suggested that activity and diversity of microbial populations were negatively correlated with the percentage of misshapen tubers.
In a study examining the abundance and structure of bacterial communities in a potato

- barley

- potato rotation, it was determined that the roots of all potato cultivars had posi tive effects on bacterial numbers

. I n the soil, diversity and community structure of bacterial communities varied with time and season, and the composition of bacterial communities is linked to the specific requirements of different cultivars. Bacterial composition was potentially related to tuber starch content, as well as specific fertilizers ( Inceoglu et al. , 2013 )

.

2. 3 .5 Biodiversity
Biodiversity refers to all plants, animals, and microorgani sms interacting in an ecosystem . Biodiversity provides valuable genetic resources for crop improvement ( Harlan, 1975 ; Wilson, 1988 ) , and also provides other functions beyond food, fiber, fuel, and income. These include pollination, genetic introgression, biological control, nutrient recycling, competition against n atural enemies, soil structure, soil and water conservation, disease suppression, control of local microclimate, control of local hydrological processes, and detoxification of noxious chemicals ( Altieri, 1999 )

. The loss of biodiversity results in a need for costly management practices in order to provide these functions to the crop ( Altieri, 1999 )

. The degree of biodiversity in an agroecosystem depends on four primary characteristics: 1) diversity of vegetation within and around the agroecosystem; 2) permanence of various crops within the system; 3) intensity of management; 4) extent of isolation of the agroecosystem from natural vegetation ( Southwood and Way, 1970 )

. Agricul tural land subject to intensive farming practices, such as that used in crop production, generally has low levels of biodiversity compared with adjacent natural areas ( Altieri, 1999 )

. Tillage, seed bed preparation, planting of a mono culture crop, pesticide use, fertilizer use, and harvest ing limits the diversity of plants and animals ( Lovett et al. , 2003 )

. Biodiversity can be maintained or reintroduced into agroecosystems through the use of woodlots, fencerows, hedgerows, and wetlands. Agronomic practices include intercropping (the planting of two or more crops simultaneously to occupy the same field), agroforestry, crop rotations, cover crops, no

tillage, composting, green manuring (grow ing a crop specifically for the purpose of incorporating it into the soil in order to provide nutrients and organic matter), and addition of organic matter ( e.g., compost, green manure, animal manure), hedgerows and windbreaks ( Altieri, 1999 )

. Because potatoes are grown through out regions of the U

. S

. , there is a large diversity of plants and animals that inhabit the areas surrounding the potato fields. These include the weeds discussed in34

Section 2. 1 , Agricultural Production and Agronomic Practices , and animals in Section 2. 3 .1 , Animal Communities.

2.4 Human and Animal Health

Humans are either consumers of potato and products derived from it, or are wor kers who produce potato crops

. Under the FFDCA, it is the responsibility of food and feed manufacturers to ensure the products they market are safe and properly labeled. Food and feed derived from GE potato must be in compliance with all applicable legal and regulatory requirements. G E organisms used for food and feed may undergo a voluntary consultation process with the FDA prior to release onto the market. Although a voluntary process, thus far , all applicants who wish to commercialize a GE variety that will be included in the food supply have completed a consultation with the FDA. In a consultation, a developer who intends to commercialize a bioengineered food meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the bioeng ineered food and then submits to FDA a summary of its scientific and re gulatory assessment of the food

. FDA evaluates the submission and responds to the developer by letter. Simplot submitted a letter of consultation on April 14, 2014, which FDA is still reviewing ( BNF No. 000146 )

. As noted by the National Research Council (NRC), unexpected and unintended compositional changes arise with all forms of genetic modification, including both conventional hybridizing and genetic engineering ( NRC, 2004 )

. Genetic modification, as a source of uncertainty, is common to all forms of plant breeding. The NRC also noted that at the time, no adverse health effects attributed to genetic engineering had been documented in the human population. Reviews o n the nutritional quality of GE foods generally conclude that there are no significant nutritional differences in conventional versus GE plants for food or animal feed ( Faust, 2002 ; Flachowsky et al. , 2005 )

.

2.4.1 Consumer Health
The potato is the world’s number one non

- grain food commodity ( FAO, 2008 ) . Potatoes are high in nutrients and at least twelve essential vitamins, especially vitamins B and C, and minerals such as iron, potassium, and zinc ( Arvanitoyannis et al. , 2008 ; FAO, 2008 ; Bushway, 2010 )

. They have the highest pro tein content (around 2.1% on a fresh weight basis) in the family of root and tuber crops. As a low

- fat source of carbohydrates, potatoes can be instrumental in providing a solution to long

- term problems of world hunger ( Bushwa y, 2010 )

. Because of their high sugar and starch content and resulting high glycemic index, persons with diabetes or similar conditions may need to eat potatoes sparingly.

U

. S

. per capita potato consum pt ion is summarized in Table 6

.



### Table 6

. U

. S

. Per Capita Potato Consumption 201 2 (lb/person/yr )

Fresh Market Processing All Potatoes Canned Frozen Chips Dehydrated Total Processing35

3 5.5 0.9 4 9.8 1 6.9 1 3.2 80.8 11 6.3

Source: ( Council, 2014 ) Toxins and Allergens in Potato

Potatoes contain two classes of toxins and/or allergens: glycoalkal o ids and patatins. Acrylamide is a toxic compound formed in cooking pot atoes at high temperatures, such as baking and frying.
Glycoalkaloids Glycoalkaloids are nitrogenous secondary metabolites found in many plant species ( Fried man and Dao, 1990 ) , whose functions are to defend against pests, predators, and pathogens ( Friedman, 2006 ; Ruprich et al. , 2009 )

. The two major glycoalkaloids present in potato are alpha

- solanine and alpha

- chaconine ( Friedman and Dao, 1990 ; Friedman, 2006 )

. At high levels, glycoalkaloids in potatoes can be toxic, and can cause poisoning symptoms such as headache, acute gastrointestinal distress ( nausea, diarrhea, vomiting, abdominal pain ) , and a burning sensation in the mouth ( Friedman, 1997 ; Ruprich et al. , 2009 ; Petersson et al. , 2013 )

. In more severe cases of poisoning, t hese symptoms may be followed by drowsiness, apathy, visual disturbance, shallow breathing, rapid and weak pulse, loss of consciousness and coma, and even death ( Friedman, 1997 ; 2006 ; Ruprich et al. , 2009 )

. A lethal dose for humans is approximately 1

- 2 mg/kg of body weight ( Friedman et al. , 1997 )

. Cases of mild toxicity are frequently overlooked and go undiagnosed because symptoms may be confused with other causes of stomach upset ( Ruprich et al. , 2009 )

. In vertebrates, glycoalkaloids disrupt cell membrane transport of calcium ions and acetylcholinesterase function ( Friedman, 1997 ; Ruprich et al. , 2009 )

. For food safety purposes, an upper limit for glycoalkaloid content of 20 0 mg/kg of potato is generally accepted ( Sinden, 1987 ; Friedman, 2006 ; Petersson et al. , 2013 )

. Levels greater than 14 mg/kg fresh weight potatoes can be perceived as bitter to human ( Friedman, 2006 ) , which appears to be an indic ator of the presence of glycoalkaloids since n aturally bitter potato cultivars contain higher levels of glycoalkaloids than do cultivars that do not taste bitter ( Jansky, 2010 )

.

Although glycoalkaloids are synthesized throughout the potato plant ( Friedman, 1997 ; Petersson et al. , 2013 ) , the highest levels are in metabolically active parts of the plant such as flowers, new leaves, and sprouts ( Friedman, 1997 ; Petersson et al. , 2013 ) . Comparatively, tubers have the lowest glycoalkaloid levels in fresh potatoes ( Friedman and Dao, 1990 ) , while sprouts, leaves and roots have greater amounts ( Friedman and Dao, 1990 )

. H igher leaves contain more total glycoalkaloids than do lower leaves

. Within tubers, the highest levels are within the first 1mm of the sk in , decreasing significantly toward the center of the tuber ( Kozukue and Kozukue, 1987 ) , so that rem oving the first 3

- 4 mm of the skin generally removes almost all of the glycoalkaloid content in tubers ( Friedman, 2006 ) . Larger tubers have higher glycoalkaloid content ( Friedman, 2006 )

. Genetic tra nsformation does not appear to affect glycoalkaloid levels ( Birch et al. , 2002 )

. Glycoalkaloid content appears to vary by cultivar and geograph ic location ( Sinden and Webb, 1972 ; Friedman et al. , 1997 )

. Levels can also be affected by environmental factors such as higher temperature36

and more light ( Friedman e t al. , 1997 )

. Delaying harvest date tends to decrease glycoalkaloid production ( Ruprich et al. , 2009 )

. U

. S

. commercial potato varieties typically have glycoa lkaloid ranges below the recommended rate of 200 mg/kg of fresh weigh potato ( a range of 20

- 130 ppm) ( Sinden and Webb, 1972 ; Friedman and Dao, 1990 ; Friedman, 2003 )

. These levels are not affected by c ooking ( Friedman et al. , 1997 ) , but may be affected by processing operations such a s slicing, peeling, and preparation for freezing and chip production ( Friedman et al. , 1997 )

. A higher concentration of glycoalkaloids ends up in skins of frozen and processed potato products, and potato chips contain more than fries ( Fried man and Dao, 1990 )

. During storage, when harvested tubers are exposed to light or become damaged , glycoalkaloid content may rise , and may result in green areas of coloration on potato skins ( Sinden, 1987 ; Center, 2010 ) ( Friedman and Dao, 1990 ; Friedman, 1997 ) ; these changes differ with cultivar and genotype ( Petersson et al. , 2013 )

. Patatins

Patatin s are a family of protein s comprising 30 to 40 % of the soluble protein in potatoes ( Mignery et al. , 1988 )

. Allergic reactions to cooked potatoes are considered to be very uncommon and were reported only in children ( De Swert et al. , 2002 )

. P atatin was identified as the major alle rgen involved in this reaction ( De Swert et al. , 2007 )

. Individuals who are allergic to patatin would need to avoid eating potatoes b ecause potato protein naturally contains a relatively large proportion of patatin.
Acrylamide Of greatest import ance to human health is the toxic compound acrylamide, which is a known carcinogen of rodents and a probable human carcinogen ( WHO

- IARC, 1994 ; NTP, 2011 ; Chawla et al. , 2012 ; Half ord et al. , 2012a )

. In particular, risk of endometrial and ovarian cancer appears to increase with increased acrylamide intake ( Pedreschi, 2009 )

. Acrylamide is also regarded as a mammalian cell mutagen, wherein very low dosages of the compound can damage chromosomes ( Chawla et al. , 2012 ) . Acrylamide has also been reported to be a cumulative neurotoxin ( Friedman, 2003 )

. Acrylamide is formed in potatoe s which are cooked at high temperatures, such as baking or frying. In 2002, Swedi sh researchers demonstrated that acrylamide forms when starchy foods, such as potatoes and breads, are heated at high temperatures, but not in unheated or boiled foods ( Tareke et al. , 2002 ; Halford et al. , 2012a )

. Therefore, even though dietary exposure to acrylamide is measurable, it is not a natural compositional component of unheated foods derived from plants. Acrylamide forms during the Maillard reaction ( Martins et al. , 2000 ) which is a reaction at high temperatures (such as frying French fries) between certain sugars such as glucose and fructose (reducing sugars) and asparagi ne (an amino acid) that are naturally present in the food ( F DA, 2009 )

. In addition, prolonged heating time increases acrylamide content, whereas higher moisture content reduces acrylamide content ( Kotsiou et al. , 2013 )

. Maillard reaction products, which affect the flavor and texture of the cooked food, are formed by a chemical reaction between an amino acid and a reducing sugar ( Halford et al. , 2012b ) . Oxidation of the free ami no acid asparagine, a major amino acid in potatoes and cereals ( Mottram et al. , 2002 ; Chawla et al. , 2012 ) , is the main source of acrylamide when starchy foods are baked or fried ( Stadler et al. , 2002 ; Friedman, 2003 ; Halford et al. , 2012a ; Kotsiou et al. , 2013 )

. Color of cooked potato products such as potato chips has been found to correlate well with acrylamide formation: the darker the color , the37

higher the greater the acrylamide concentration ( Arvanitoyannis et al. , 2008 ; Pedreschi, 2009 ; Halford et al. , 2012a ; Kotsi ou et al. , 2013 )

. Important varia bles leading to acrylamide formation and affecting acrylamide concentration in cooked potatoes include the reducing sugar content, processing/cooking temperature and method, cooking/processing time, moisture content, and additives ( Halford et al. , 2012a ; Kotsiou et al. , 2013 )

. In turn, concentrations of sugars and amino acids are influenced by cultivar, fertilizers, climate, and storage conditions ( Pedreschi, 2009 )

. It is estimated that potato chips and fried potato products such as French fries are responsible for about 1/3 of the human dietary exposure to acrylamide ( Chawla et al. , 2012 )

. Because of higher rates of

cons umption of potato chips and French fries by children, adolescents, and males under the age of twenty

- five, acrylamide exposure to these groups is likely to be higher ( Dybing et al. , 2005 )

. Acrylamide is also present in other foods such as coffee, some breads, biscuits, gingerbread, and processed onion mix and dip mixes. Smoking may also contribute to human exposure to acrylamide ( Friedman, 2003 ; Chawla et al. , 2012 ; Kotsiou et al. , 2013 )

. For all of these reasons, the discovery of acrylamide in cooked potato products has raised concerns throughout the potato processing industry, as well as among consumers. The Food and Agriculture Organization/World Health Organization ( FAO/WHO ) Expert Committee on Food Additives h as recommended that dietary exposure to acrylamide should be reduced ( FAO/WHO, 2011 ) . Perhaps because children consume more acrylamide

- laden products such as French fries and potato chips, their exposure to the chemical is greater than for adults ( Friedman, 2003 ; Halford et al. , 2012b )

. The State of California listed acrylamide as a potential carcinogen under Proposition 65 in 1990 and establi shed a No Significant Risk Level (NSRL) of 0.2 μg/ day ( CEPA

- OEHHA, 2005 ) . Subsequent to the discovery of acrylamide in cooked foods, this NSRL was revised to 1.0 μg/day ( CEPA

- OEHHA, 2005 )

. FDA has recently released draft guidance for the food industry to reduce acrylamide in foods ( FDA, 2013b )

.

2.4.2 Worker Health
Worker hazards in farming are common to all types of agricultural pro duction, and include hazards from equipment and plant materials. Pesticide application represents the primary exposure route to pesticides for farm workers. Workers engaged in potato production may encounter insecticides, herbicides, fungicides or fertilizers that may pose a worker health or safety risk , unless used i n accordance with the U

. S

. - EPA established agriculture

- specific requirements in the Worker Protection Standard (WPS) (40 CFR Part 170) that protect workers from the hazards of chemical exposure. The WPS offers protections to more than two and a half milli on agricultural workers who work with pesticides at more than 560,000 workplaces on farms, forests, nurseries, and greenhouses. The WPS contains requirements for pesticide safety training, notification of pesticide applications, use of personal protective equipment, restricted entry intervals following pesticide application, decontamination supplies, and emergency medical assistance. The Occupational Safety and Health Administration require all employers to protect their employees from hazards associated with agricultural chemicals. The EPA pesticide registration process, however, involves the design of use restrictions that , if followed , have been determined to be protective of worker health.3 8

A potato field is a highly managed environment which incorpora tes the use of agricultural chemicals, including herbicides and insecticides. Pesticides are used on most potato acreage in the U

. S

. , and changes in acreage, crops, or farming practices can affect the amounts and types of pesticides used and thus the risks to workers. Worker safety precautions and use restrictions are noted clearly on pesticide registration labels. Growers are requir ed to use pesticides consistent with the application instructions provided on the EPA

- approved pesticide labels. These restrictions provide instructions as to the appropriate levels of personal protection required for agricultural workers. These may incl ude instructions on personal protective equipment, specific handling requirements, and field reentry procedures ( see, e.g. ( Carroll and Robinson, 2006 ) )

.

2. 4.3 Animal Feed

Potatoes used as livestock feed accounted for approximately 1 % of a ll potato es produced in the U

. S

. in 2012 (see Table 7 ). This quantity includes potatoes sold specifically as livestock feed and potatoes used as livestock feed on farms where the crop was grown. It does not include the potato waste that was used for livestock feed ( USDA

- N ASS, 2013c )

. Use of potatoes for livestock feed is generally dependent on quality and price : for example, when potatoes are low in both price and quality, more of the crop tends to be used for livestock feed. Prices for feed are usually the lowest of all potato usage categories ( Guenther, 2010d )

.39

Table 7

. U

. S

. 2012 Potato Utilization

Utilization Item CWT (1,000) (% of potatoes harvested)

Sales

– fresh and processing
Table stock (fresh) 118,535 (25.6%)

Processing Chips and shoestrings 56,349 (12.2%) Dehydrated (except starch and flour) 50,559 (10.9%)

Frozen French fries 144,910 (31.3%)
Other frozen products 20,912 (4.5%)
Canned products 1,764 (0.4%) Other canned products (hash, stews, soup) 695 (0.2%)
Starch, flour and other 8,031 (1.7%)
Total processing 283 ,220 (61.0%)

Other sales

Livestock feed 4,080 (0.9%)

Seed 23,706 (5.1%)

Non

- sale Seed used on farms where grown 3,286 (0.7%)
Household and feed use on farms where grown 1,583 (0.3%)
Shrinkage and loss 28,356 (6.1%)

Total Production 462,766

Source: ( USDA

- NASS, 2013c )

P otatoes constitute at least part of the diet for several domestic animals, including dogs, cattle, horses, pigs, and poultry. The recommended rate of feed is approximately 25

- 40 lb

. potatoes/1,000 lb

. live weight, but can vary with the type of animal. Po tatoes are considered to be a palatable feed, and are high in moisture content, but are not as nutritious as grain or corn silage (e.g., it takes 400

- 500 lb

. of potato es to provide the same nutritive value as 100 lb s. of grain ) ( Corbett, No Date )

.40

Feed does not include the leafy green f oliage of potato plants since flowers, sprouts, and foliage have abundant glycoalkaloids, which are potentially poisonous for livestock ( Sinden, 1987 )

. Similar to the regulatory control for direct human consumption of potato under the FFDCA, it is the responsibility of feed manufacturers to ensure that the products they market are safe and properly labeled. Fe ed derived from GE potato must comply with all applicable legal and regulatory requirements, which in turn protects human health. To help ensure compliance, GE organisms used for feed may undergo a voluntary consultation process with FDA before release on to the market, which provides the applicant with any needed direction regarding the need for additional data or analysis, and allows for interagency discussions regarding possible issues. Consequently, any uncertainty in this area is addressed during an F DA inquiry process. Although a voluntary process, thus far all applicants who wish to commercialize a GE variety that will be included in the food supply have completed a consultation with the FDA. In a consultation, a developer who intends to commercialize a bioengineered food meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the bioengineered food and then submits to FDA a summary of its scientific and re gulatory assessment of the food . FDA evaluates the submission and resp onds to the developer by letter

. Simplot submitted a letter to FDA on April 14, 2014, whi ch FDA is currently reviewing (BNF No. 000146 )

.

2. 5 Socioeconomics
As part of an evaluation of impacts on the h uman enviro nment , NEPA requ ires consideration of economic and social effects (40 CFR 1508.8) , whether direct, indirect, or cumulative. However, under CEQ regulations (40 CFR 1508.14) , “

. . . economic or social effects are not intended by themselves to require prepar ation of an environmental impact statement .”
The following s ocioeconomic factors are considered i n this EA : the interaction of social and economic factors that affect agricultural production and products, including farm income and employment, crop production expenses, crop value and trade

.

2. 5 .1 Domestic Economic Environment
Potatoes contribute approximately 15 % of farm sales receipts for vegetables, making potatoes the leading veg etable crop in the U

. S

. ( USDA

- ERS, 2012b ) . The total value of U

. S

. potato production in 2012 was $3.9 billio n, the average yield was 409 cwt /acre and the average price received was $7.26/ cwt ( USDA

- NASS, 2012c ) . Unlike true commodity crops such as corn and soybeans, most potatoes are grown for a specific market. T he Russet Burbank variety is pr imarily used for French fries , but can be used fresh for baking ( Pa vek et al. , 1992 ; PAA, 2009 )

. Specific varieties are not grown for the dehydration market or for livestock feed; rather, food

- grade potatoes considered unsuitable for their intended f resh or other processing markets are usually used for these purposes ( Guenther, 2010d ) . Because potato sales for livestock feed usually receive the lowest price , potatoes are not sold for livestock feed if other uses are available ( Guenther, 2010d )

.41

Fresh market potatoes in North America can be classified broadly as rus sets, reds, yellows or whites , based on skin color. Most eastern potato growers also are involved in packing; in the west, the businesses are usually separate , although r ecently, some western growers have entered the packing business, often in partnership s or cooperatives wi th other growers ( Guenther, 2010b )

. Fresh potatoes may be shipped in refrigerated rail cars or trucks to maintain a high standard of quality whereas frozen and dehydration processing typically occurs near potato production areas. The fragility of chips and the high cost of shipping low

- dens ity products results in most chipping plants being located near populated areas. Except for dehydrators, processors typically contract for most of their needs and buy the remainder on the open market. Some dehydrators segregate potatoes that are suitable for the fresh market, and then sell those on the fresh market, processing the rest. Others purchase off

- grade potatoes from fresh packers for processing ( Guenther, 2010c )

. Revenues and costs of potato production v ary widely, depending on geography, growing conditions, the local economy, the type of potato, farm size, and other factors. For example, the 2011 per acre operating cost of growing Russet Burbank potatoes in s outhwestern Idaho, including on

- farm storage and fumigation, was $2,811 ( Patterson, 2011 ) . In the same year, the gross return per acre averaged $4,107.50, resulting in a net return of $1,297. When that same variety was grown in south

- c entral Idaho, the 2011 per acre operating cost, including o n

- farm storage and fumigation, was $2,56 0 ( Patterson, 2011 ) , and the gross return per acre averaged $3681.25, result ing in a net return of $1,121.

A pproximately 90 % of U

. S

. potatoes are planted in the spring and harvested in the fall, and western
stat es produce two

- thirds of the fall potatoes. The storage abilities of potatoes enable fall

- season potato varieties to be sold in fresh or processing markets throughout the September

- August marketing year. Less than 10 % of potatoes are harvested in winter, spring and summer; however, these potatoes meet specific market needs (e.g., new potatoes) and tend to yield higher prices than fall potatoes ( USDA

- ERS, 2012b )

. Sale value s per acre are normally highest for the winter crop and lowest for fall potatoes, but varies widely among the producing states. Prices for fresh potatoes are usually higher than prices for processing potatoes due to crop

- quality standards. Domestic potat o prices may vary not only in response to changes in weather, yield or demand, but also to changes in supply from imported potatoes and potato products. If a large quantity of frozen French fries enters the country, U

. S

. potato processors may cut back on contracts for processing potatoes, which would be diverted to the fresh market. Fresh market prices would likely fall as a re sult ( USDA

- ERS, 2012b )

. Not all potatoes are sold for food. The largest non

- sales category is “shrinkage and loss”, which accounts for the water weight loss and loss due to respiration during storage. Also in this category are potatoes that do not meet market quality standards due to decay, bruising, greeni ng, sprouting and disease. Crops that suffer frost damage also are added to this category ( Guenther, 2010d )

. Potato production requires numerous expenditures, i ncluding for specialized machinery. The largest conventional operating cost items are fertilizer, chemicals and pesticides, storage and seed potatoes. Fertilizer and seed accounted for 25 % of total production costs in eastern Idaho in 2007 ( Patterson, 2010 ) . Potato production costs for irrigat ion in the western U

. S

. ranges between $1,500 and $3,500 per42

acre ( Patterson, 2010 ) . Costs do not stop accumulating at harvest unless the potatoes are sold out of the field. Additional costs are incurred to store potatoes.
For those produc ing organic potatoes, an organic production system is required in addition to a relatively long crop rotation to minimize pest problems. Profitability margins differ between organic farm sizes, but a study conducted in southern Idaho indicated that net re turn over variable costs for a small farm (30

- 50 acres) with 100% organic premiums is $1,026/acre and $1,148/acre for a large farm (100

- 120 acres) ( Painter et al. , 2010 ) . Smaller farms have higher operating costs as a result of smaller, less efficient machinery, and their machine hours for potato production are more than double the hours on a larg e organic farm. While larger farms reduce labor expenses by half with more efficient machinery, they do have an increase in capital costs. Organic potato growers face challenges, including growing sufficient fall cover crops to supply soils with addition al nitrogen, but profit margins for organic potatoes have the potential to exceed those for conventional potatoes if these and other challenges are addressed ( Painter et al. , 2010 )

. In general, post

- harvest losses are a significant part of the production costs of fruits and vegetables, and may reach as high as 50% ( Martinez and Whitaker, 1995 ; Llorente et al. , 2011 )

. Browning of fruits and vegetables negatively affects consumer acceptance because of altered appearance and perceived nutritio nal deficit ( Llorente et al. , 2011 )

. Specifically, potato growers can lose up to 20% of income through potato injury at harvest ( Preston, 2010 )

. The potato industry, therefore, has a vested intere st in minimizing these losses.
Black spot bruise
Black spot bruise is typically caused by mechanical injury to tubers during harvest, handling, storage, or processing such as scuffing and cracking of the skin ( Dirks

- Hofmeister et al. , 2013 )

. Injury leads to a bluish

- grey to black discoloration of internal tuber tissue ( Stremmel et al. , 2010 ) . Bruising symptoms do not appear until 3 hours to 24 hours following mechanical impact, and are not visible until the skin is removed from the tuber ( Stremmel et al. , 2010 ; Urbany et al. , 2011 )

. Because bruising cannot be observed until the potato skin is removed, it is more difficult to identify damaged tube rs, and makes conventional means of breeding to eliminate this trait more problematic ( Urbany et al. , 2012 )

. Physical tuber properties, such as tissue stiffness and elasticity, affect transfer of the impact energy to the tuber and may affect susceptibility of the tuber to bruising. For example, if potato tissue does not crack during injury, the force of the impact is more evenly distributed throughout a larger area of the tuber, which results in greater changes to metabolism, a nd, hence more bruising ( Stremmel et al. , 2010 )

. Therefore, bruising susceptibility varies widely among potato cultivars ( Stremmel et al. , 2010 )

. To a large extent, susceptibility is dependent on multiple genetic traits, as well as on maturity of tubers and environmental factors ( Urbany et al. , 2011 )

. Potato genotypes with high tuber starch content are more susceptible to bruising ( Urbany et al. , 2012 )

. The chemical basis for black spot bruising lies in the cellular release of phenolic compounds, normally compartmentalized in the vacuoles, following injury ( Tran et al. , 2012 )

. The phenolic compounds are converted to o

- phenols and o

- quinones by the enzyme polyphenol oxidase (PPO) ( Dirks

- Hofmeister et al. , 2013 ) . These quinoids auto

- oxidize, forming melanin, leading to blackened tissue which is called enzymatic browning and is undesirable in processed potato product s ( Hunt et al. , 1993 ; Steffens, 1994 ;43

Stremmel et al. , 2010 ; Llorente et al. , 2011 ; Vitti et al. , 2011 )

. Oxidative browning reactions generally cause deterioration in food quality by changing nutritional and organoleptic properties, and can involve changes in texture and flavor as well as color ( Yoruk and Marshall, 2003 ) . The side chains of essential amino acids in plant proteins may interact with quinones, leading to a reduction in nutritional quality ( Yoruk and Marshall, 2003 )

. Degree of discoloration is strongly related to PPO activity ( Urbany e t al. , 2011 )

. Polyphenol oxidase expression is mediated by a multi

- gene family in potato ( Thygesen et al. , 1995 ; Llorente et al. , 2011 )

. Storage temperatures also affect the likelihood of black spot bruise ( Preston, 2010 ) since increased temperature heightens PPO activity ( Yoruk and Marshall, 2003 ; Vitti et al. , 2011 )

. Reducing Sugars
The levels of reducing sugars (sugars which can be oxidized) in potato are critically important because of maintenance of product quality throughout storage and processing ( Olsen et al. , 2005 )

. In potato, the reducing sugars of interest are glucose and fructose ( Olsen et al. , 2005 )

. High levels of reducing sugars may lead to unacceptably dark colors when cooking frozen or processed potatoes , and bitter tast e ( Bethke et al. , 2009 )

. In addition, reducing sugars react with amino acids during cooking in the Maillard reaction ( O'Brien et al. , 1989 ; Bhaskar et al. , 2010 ) , and as such, are important factors in acrylamide formation in fried potato products ( Zhu et al. , 2014 )

. At harvest, most potatoes contain low levels of reducing sugars

. Minimizing the time between vine kill and harvest is recommended to m aintain these low levels ( Olsen et al. , 2005 )

. In general, the lower the storage temperature for tubers, the greater the concentration of sugars ( Olsen et al. , 2005 ) . Because potatoes may frequently need to be stored for up to 12 months before processing , maintenance of low levels of reducing sugars is a challenge for processors ( Olsen e t al. , 2005 )

. If tubers are stored too long, reducing sugars tend to accumulate ( Driskill et al. , 2007 )

. If sugar levels rise too high, processors may reject them for use as fries or chips, and growers may be forced to sell them for lower prices to other markets ( Driskill et al. , 2007 )

. Currently potatoes that are intended for fry production are kept at 46 o

- 48 o F ( Olsen et al. , 20 05 ; Driskill et al. , 2007 ; Wu et al. , 2011 ) , which represents a compromise between the potential weight l oss, increased disease pressure and accompanying spoilage, and sprouting, that comes with warmer temperatures, and the problems of cold

- induced sw eetening (CIS) , which leads to increased acrylamide potential, and decreased product quality ( Driskill et al. , 2007 )

. Another problem caused by high levels or reducing sugars is called sugar e nd defect by the potato industry ( Driskill et al. , 2007 ) which can result from une ven environmental conditions during tuber initiation and early tuber bulking ( Zhu et al. , 2014 ) . This occurs when reducing sugar levels rise and preferentially settle in the basal end of the potato, so that there is an uneven distribution of sugars in processed potatoes and a resulting darker color in those sections: for example , one end of a French fry will be darker than the other ( Zhu et al. , 2014 )

. I f levels of sugar ends are extremely high, the potatoes cannot be used for premium French fries, and may result in loss of economic value to the processo rs ( Zhu et al. , 2014 ) . These defects may also result in higher prices for consumers ( Zhu et al. , 2014 )

.
For all of these reasons, breeders and growers strive to produce potatoes destined for processing that maintain a stable, relatively low level of reducing sugars throughout storage ( Driskill et al. , 2007 )

.44

2. 5 .2 Trade Economic Environment

U

. S

. and global trade are greatly affected by the growth and stability of world markets, including changes in world population, economic growth, and income. Other factors affecting agricultural trade are global supplies and prices, changes in exchange rates, government support for agriculture, and trade protection policies.

U

. S

. farmers and agricultural firms rely heavily on export markets to sustain prices and reven ues because productivity of U

. S

. agriculture increases faster than the demand fo r domestic food and fiber. U

. S

. food imports have increased with the corresponding increase in demand for greater diversity in the food supply . U

. S

. consumers benefit from imports because imports expand food variety. This also tends to stabilize year

- round supplies of and prices for fresh fruits and vegetables.

U

. S

. exports of potatoes and potato products have grown 133 % in value and 79 % in volume during the last 10 marketing years ( Board, 2013 ) . Frozen potato products comprise 60 % of the U

. S

. potato exports. During the 2012/ 2013 market year (September

- August), U.S exports of potatoes and potat o products totaled $1.6 billion

-- up from $1.4 billion in the previous market year ( USDA

- ERS, 2013 ) . Exports to target markets were led by an increase in shipments to Mexico, South Korea, Malaysia, and Vietnam. During the 2012/ 2013 market year, Canada was the largest market for chips while Japan was the largest market for frozen potato products and dried, flour, and meal potato products ( Board, 2012 ; USDA

- ERS, 2013 ) . M exico provides the U

. S

. with the largest market for exporting potato flakes and granules and is the second largest market destination for frozen potatoes ( Board, 2012 ; USD A

- ERS, 2013 )

. U

. S

. potato and potato product exports are expected to grow during the upcoming marketing year ( Board, 201 3 ) . Growth rates will depend upon economic growth in the markets and the supply and price of competitor prod ucts. The U

. S

. will facilitate the growth of the export market by continuing to gain new market access, as recently occurred for fresh table

- st ock to the Philippines ( Board, 2013 )

.

2. 5 .3 Organically Certified Economic Environment

In the U

. S

. , products produced using only specific methods and certified under the USDA AMS N ational Organic Program (NOP) definition of organic farming can be marketed and labeled as “organic ” ( USDA

AMS, 2010 ) . Organic certification is a process

- based certification ; not a certification of the end product

. T he certification process specifies and audits the methods and procedures by which the product is produced.

I n accordance with NOP, each year an accredited organic certifying agent must review an operation. This must include a review of its organic system plan and record

- keeping practices, and an on

- site inspection of the production area(s). Organic growers must maintain records to show that production and handling procedures comp ly wit h USDA organic standards. Section 205.105 of the regulations identifies “ Allowed and prohibited substances, methods, and ingredients in organic production and handling. “To be sold or labeled as ‘100 percent organic,’ ‘organic,’ or ‘made with organic’ (spe cified ingredients or food group(s)),” the product must be produced and handled without the use of: . . . (e) Excluded methods . . . .”45

E xcluded methods identified at 7 CFR Section 205.2 , are defined as follows: “A variety of methods used to genetically modify organisms or influence their growth and development by means that are not possible under natural conditions or processes and are not considered compatible with organic production. Such methods include cell fusion, microencapsulation and macroencapsu lation, and recombinant DNA technology (including gene deletion, gene doubling, introducing a foreign gene, and changing the positions of genes when achieved by recombinant DNA technology). Such methods do not include the use of traditional breeding, conju gation, fermentation, hybridization, in vitro fertilization, or tissue culture.”
Organic farming operations, as described by the NOP, are required to have distinct, defined boundaries and buffer zones to prevent unintended contact with excluded methods fro m adjoining land that is not under organic management. Organic production operations must also develop and maintain an organic production system plan approved by their accredited certifying agent. This plan enables the production operation to achieve and document compliance with the National Organic Standards, including the prohibition on the use of excluded methods ( USDA

- AMS, 2010 )

. Common practices organic growers may use to exclude GE products incl ud e planting only organic seed, planting earlier or later than neighboring farmers who may be using GE crops , so that the crops will flower at different times, and employing adequate isolation distances between organic and neighboring fields to minimize the chance for pollen exchange between fields ( NCAT, 2003 ) . Although the n ational

o rganic s tandards prohibit the use of excluded methods, they do not require testing of inputs or products for the presence of excluded methods. The presence of a detectable residue of a product of excluded methods alone does not necessarily constitute a violation of the n ational o rganic standards ( USDA

- AMS, 2010 ) . The current NOP regulations do not specify an acceptable threshold level for the adventitious presence of GE materials in an organic

- labeled product. The unintentional presence of the products of excluded methods will not affect the status of an organic product or operation if excluded methods were used and reasonable practices were implemented to avoid contact with products of excluded methods as deta iled in their approved organic system plan ( Ronald and Fouche, 2006 ; USDA

AMS, 2010 )

. Organic market and products
The organic sector is rapidly g rowing both in the U

. S

. and the EU. C onsumer purchases in these two regions made up 95 % of estimated world retail sales of organic f ood products in 2003 ( Dimitri and Oberholtzer, 2009 )

. Annual manufacturer survey results ( Organic Trade Association, 2011 ) indicated that estimated U

. S

. organic food sales for 2010 were $26.7 billion. This represented a 7.7 % growth rate from the previous year

. The market sector e xperiencing the highest growth rate during 2010 was organic fruits and vegetables, which incr eased 1 1.8 % compared with 2009 sales. The market share for

o rganic fruits and vegetables was 11% of all U

. S

. fruit and vegetable sales ( Organic Trade Association, 2011 ) . Organic products represented approximately 4 % of total 2010 sales in the food and beverage
sector ( Organic Trade Association, 2011 )

. Organic Potatoes46

In 20 08 , 2.2 million cwt of organic potatoes were harvested, with a total sales value of almost $29 million ($13. 24 / cwt ) ( USDA

- NASS, 2012a )

. Prices for organic potatoes are ty pically substantially higher than the overall average conventional pot ato price, and probably reflect both the organic premium and the fact that most organic potatoes are sold fresh. Organic growers typically receive a significant price premium when they can sell their potatoes as organic ( Dufour et al. , 2009 ) ; however, that market is not al ways available ( Esplin, 2009 )

. The organic potato market is not highly structured ( Dufour et al. , 2009 )

. At least one manufacturer produces organic potato chips ( Foods, 2009 )

.47

3. ALTERNATIVES
This document analyzes the potential environmental consequences of a determination of nonregulated status of Simplot InnateTM W8 p otato

. Two alternatives are evaluated in this EA: (1) no action and (2) determination of nonregulated status of event. APHIS has assessed the potential for environmental impacts for each alternative in the Environmental Consequences section.

3.1 No A ction Alternative: Continuation as a Regulated Article

Under the No Action Alternative, APHIS would deny the petition. Simplot Innate TM W8 p otato and progeny derived from Simplot Innate TM W8 p otato would continue to be regulated articles under the regulations at 7 CFR part 340. Permits issued or notifications acknowledged by APHIS would still be required for introductions of Simplot Innate TM W8 p otato and measures to ensure physical and reproductive confinement would continue to be implemented. APHIS might choose this alternative if there were insufficient evidence to demonstrate the lack of plant pest risk from the unconfined cultivation of Simplot Inn ate TM W8 p otato

. This alternative is not the P referred Alternative because a Plant Pest Risk Assessment (PPRA) found Simplot Innate TM W8 p otato is unlikely to pose a plant pest risk ( USDA

- APHIS, 2014b )

. Choosing this alternative would not satisfy the purpose and need of making a determination of plant pest risk status and responding to the petition for nonregulated status.

3.2 Preferred Alternative: Determination T hat Simplot InnateTM W8 Potato I s No Lon ger a Regulated Article

Under this alternative, Simplot Innate TM W8 p otato and derived progeny would no longer be regulated articles under the regulations at 7 CFR part 340. Permits issued or notifications acknowledged by APHIS would no longer be required for introductions of Simplot Innate TM W8 p otato and progeny derived from this event. U nder this alternative, growers may have fu ture access to Simplot InnateTM W8 p otato and progeny derived from this event if the developer decides to commercialize Simplot InnateTM W8 p otato. This alternative meets the purpose and need to respond appropriately to a petition for nonregulated
status when there is a determination of no pest risk. B ased on the PPRA conclusion that Simplot Innate TM W8 p otato is unlikely to pose a plant pest risk ( USDA

- APHIS, 2014b ) , conferring nonregulated
status to Simplot Innate TM W8 p otato is a response that is consistent with the plant pest provisions of the P lant P rotection A ct and the regulations codified in 7 CFR part 340

.
3.3 Alternatives Considered But Rejected from Further Consideratio n
APHIS assembled a list of alternatives that might be considered for Simplot Innate TM W8 p otato . The agency evaluated these alternatives, in light of the agency's authority, environmental safety, efficacy, practicality , and other concerns. A PHIS rejected several alternatives based on the discussions summarized in this section

.48

3.3.1 Prohibit Any Simplot InnateTM W8 Potato from Being Released

In response to public comments stat ing a preference for GE organisms t o not enter the marketplace, APHIS considered prohibiting the release of Simplot Innate TM W8 p otato , including denying any permits associated with the field testing. APHIS determined this alternative is not a reasonable alternative because APHIS found Simplot In nate TM W8 p otato is unlikely to pose a plant pest risk ( USDA

- APHIS, 2014b )

. 3.3.2 Approve the P etition in P art
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 of nonregulated status in part may be appropriate if there is a plant pest risk associated with some, but not all lines described in a petition. Because APHI S has concluded that Simplot InnateTM W8 potato is unlikely to pose a plant pest risk, there is no regulatory basis for considering approval of the petition only in part.

3.3.3 Isolation Distance between Simplot Innate TM W8 Potato and Non

- GE Potato Producti on and Geographical Restrictions
In response to public concerns of gene movement between GE and non

- GE plants, APHIS considered requiring an isolation distance separating Simplot Innate TM W8 p otato from conventional or specialty potato production. Isolation distances may be useful when wind

- borne pollen is likely to disseminate genes long distances. Potato is not considered to be a wind

- pollinated crop (OECD, 1997b), so imposing an ineffective restriction makes this alternative unreasonable

. Furt her, an alternative based on requiring isolation distances would be inconsistent with the finding that Simplot InnateTM W8 p otato is unlikely to pose a plant pest risk ( USDA

- APHIS, 2014b )

.
APHIS also cons idered geographically restricting the production of Simplot Innate TM W8 p otato . The restrictions could be based either on the production locations of non

- GE potato in organic production systems , or production systems for GE

- sensitive markets , or in response to public concerns regarding possible gene movement between GE and non

- GE plants. The PPRA did not identify geographic differences associated with any identifiable plant pest risks for Simplot InnateTM W8 p otato ( USDA

APHIS, 2014b ) and found it will not exhibit a greater plant pest risk in any geographically restricted area. To restrict production locations when there is unlikely to be any productive value creates an ineffective restriction that makes this alternative unreasonable. Further, an alternative based on restrictions to production locations would be inconsistent with the finding that Simplot InnateTM W8 p otato is unlikely to pose a plant pest risk ( USDA

- APHIS, 2014b )

. Based on the foregoing, the imposition of isolation distances or geographic restrictions would not meet APHIS’ purpose and need to respond appropriately to a petition for nonregulated status based on the requirements in 7 CFR part 340 and the agency’s authority under the plant pe st provisions of the PPA. Nevertheless, APHIS is not expecting significant effects. However, individuals might choose on their own to geographically isolate their non

- GE potato production systems from Simplot InnateTM W8 potato, or to use isolation distan ces and other management practices to minimize gene movement between potato49

fields. Information to assist growers in making informed management decisions for Simplot Innate TM W8 p otato is available from the Association of Official Seed Certifying Agencies ( AOSCA, 2010 )

. 3.3.4 Requirement of Testing for Simplot InnateTM W8 Potato
During the comment periods for other petitions for nonregulated status, some commenters requested USDA to require and provide testing for GE products in non

- GE production systems. APHIS notes there are no nationally

- established regulations involving testing, criteria, or limits of GE material in non

- GE systems. Such a requirement would be extremely difficult to implement and maintain even if it was within APHIS’s statutory authority to establ ish this type of system

. The inability to implement and maintain this type of system makes this potential alternative unreasonable.

3.4 Comparison of Alternatives

Table 8 includes a summary of the potential impacts associated with selection of the alternatives evaluated in this EA . The potential environmental consequences are presented in Section 4 of this EA

.



### Table 8

. Summary of Issues of P otential Impacts and Consequences of A lternatives

Attribute/Measure Alternative A: No Action Alternative B: Determination of Nonregulated Status Meets Purpose and Need and Objectives No Yes

Unlikely to pose a plant pest risk Satisfied through use of regulated field trials Satisfied

– risk assessment ( USDA

- APHIS, 2014b )
Management Practices

Acreage and Areas of Potato Production Total commercial potato production has increased while land area dedicated to potato has decreased. Based on potato production trends and projections, potatoes will continu e to be a major crop in the U

. S

. for the foreseeable future. Total acreage dedicated to potato is unlikely to change, but adoption of Simplot InnateTM W8 p otato may reduce acreage dedicated to conventional potatoes.

Agronomic Practices Agronomic practices will remain the same as used currently. Unchanged from No Act ion Alternative , .50



### Table 8

. Summary of Issues of P otential Impacts and Consequences of A lternatives

Attribute/Measure Alternative A: No Action Alternative B: Determination of Nonregulated Status

Pesticide Use Pesticides are currently used to control insects, nematodes, fungi, and weeds. Unchanged from No Action Alternative

.

Potato Seed Production Potato seed is primarily supplied by seed potatoes. Unchanged from No Action Altern a tive

.

Organic Potato Production Organic potato growers use practices and 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. Unchanged from No Action Alternative

.

Environment

Water Resources T he p r im a r y c a use of

a g r i c ultu ral non

- point source pollution is in crea s e d

s e dim e nt a tion fr om soil

er osion, w hi c h ca n int r odu c e
s e d i m e nts, fer tili z er s, a nd p e sti c id e s to n ear b y l a k e s a nd st r e a ms. A g r o nomic p rac ti ce s
s u c h a s c r op nut r i e nt
m a n a g e m e nt, p e st
m a n a g e m e nt, a nd c o ns er v a tion bu ffer s h e lp p r ot ec t w a t e r qu a li t y fr om a g r i c ultu r a l r uno f f. Water usage for irrigation would be expected to continue to increase. Unchanged from No Action Alternative

.51



### Table 8

. Summary of Issues of P otential Impacts and Consequences of A lternatives

Attribute/Measure Alternative A: No Action Alternative B: Determination of Nonregulated Status

Soil Quality A g r onomic p r a c ti ce s su c h a s
cr op t y p e , till a g e , a nd p e st
m a n a g e m e nt ca n a f f e c t soil qu a li t y

. G r o wer s w ill a dopt

m a n a g e m e nt p rac ti ce s to
a dd re ss th e ir s p ec i f ic n e e ds in p r odu c i n g potatoes. Erosion potential may continue to increase. Unchanged from No Action Alternative

.

Air Quality A gr i c u l tu r a l a c t i v i t i e s su c h a s b u r n i n g, till in g , h a r

v e s t in g , sp r a y in g p e st i c i d e s , a n d fe r t i li z in g , in c l ud in g th e e mi s si o ns f ro m f a r m e qu i p m e n t , c a n d i r ec t l y a f fec t a i r q u a li t y

. Ae r i a l

a pp l i ca ti o n o f herbicides m a y i m p a c t a i r q u a l i t y f ro m d r i f t , d i f f u s i o n , a n d v o l a t i li z a t i on o f t h e
c h e m i c a l s , a s w e l l a s m o t o r
v e h i c l e e m i ss i o n s f r o m a i r p l a n e s
o r h e l i c o p t e r s. Unchanged from No Action Alternative

.

Climate Change A g r i c ultu re

- re l a t e d ac tiviti e s
ar e rec o g ni z e d a s both di r e c t
sou rce s of g r ee nhouse g a s e s ( GHG s ) (e

. g ., e x h a ust fr om moto r i z e d e quipm e nt) a nd indi rec t sou r c e s (e

. g ., a g r i c ultu re

- r e l a t e d soil distu r b a n ce , f er tili z e r p r o du c tion. Unchanged from No Action Alternative

.

Animal Communities Potato fields may be host to many animal and insect species. Many of these animals are typically considered pests and may be controlled by the use of integrated pest management strategies

. Animals consuming Simplot InnateTM W8 tubers may be exposed to increased levels of glutamine, but this is not expected to be detrimental.52



### Table 8

. Summary of Issues of P otential Impacts and Consequences of A lternatives

Attribute/Measure Alternative A: No Action Alternative B: Determination of Nonregulated Status

Plant Communities Potatoes are a labor intensive, highly managed crop. Members of the plant community that adversely affect potato production may be characterized as weeds. Weed control is an important aspect of potato production. Potato g r o wer s use p r odu c tion p rac ti ce s to m a n a g e w e e ds in

a nd ar ound potato fields. In the un likely event of hybridization of Simplot InnateTM W8 p otato with conventional varieties, resulting progeny may contain lowered polyphenol oxidase levels. However, this is not expected to be detrimental. Simplot InnateTM W8 p otato is no weedier than convent ional potatoes.

Gene Flow Since potato is primarily vegetatively propagated, gene flow between cultivars is low. Volunteer potatoes would continue to need to be controlled, although their survival is low. Simplot InnateTM W8 traits are not expected to increase weediness in potato.

Soil Microorganisms Abundance and diversity of soil microorganisms in and around potato fields is expected to remain as it is currently. Unchanged from No Action Alternative

.

Biological Diversity The biological diversity in potato fields is lower than in the surrounding habitats. Unchanged from No Action Alternative

.

Human and Animal Health

Risk to Human Health Glycoalkaloids and patatins would continue to pose a risk to human health. In the case of humans consuming high

temperature cooked potatoes, they would continue to be exposed to acrylamide. Glycoalkaloid and patatin exposure would continue. For humans consuming high

temperature cooked potatoes, acrylamide levels

c ou ld be reduced ap proximately 6 0

- 70%, which would benefit human health.53



### Table 8

. Summary of Issues of P otential Impacts and Consequences of A lternatives

Attribute/Measure Alternative A: No Action Alternative B: Determination of Nonregulated Status

Risk to Animal Feed Glycoalkaloids would continue to pose a risk to livestock if potato stems and foliage are fed to them, which is not likely. Unchanged from No Action Alternative.

Socioeconomic

Domestic Economic Environment Most potato production is used for food. Market utilization would likely continue as it is currently. Because of its potential human health benefits (lower acrylamide , lower reducing sugars ) and potential reduced wastage (low bruising , late blight resistance ), Simplot InnateTM W8 p otato may comprise a larger share of the domestic potato market , and may result in increased

revenues

.

Trade Economic Environment U

. S

. potatoes and potato products will continue to play a role i n global potato production, and the U

. S

. will continue to be a supplier in the international market. The foreign trade impacts associated with a determination of nonregulated status of Simplot InnateTM W8 potatoes are anticipated to be similar to the No Ac tion Alternative. However, import of each specific trait requires separate application and approval by the importing country. If the Simplot InnateTM W8 traits are approved by importing countries, it may make up a larger percentage of potato import markets

. Other Regulatory Approvals

U

. S

. FDA completed consultations, EPA tolerance exemptions and conditional pesticide registrations granted FDA is currently reviewing Simplot’s voluntary consultation submission of April 14, 2014

.54



### Table 8

. Summary of Issues of P otential Impacts and Consequences of A lternatives

Attribute/Measure Alternative A: No Action Alternative B: Determination of Nonregulated Status

Other countries Countries importing potatoes would continue to do so. Simplot would need to obtain regulatory approvals from any nations which plan to import Simplot InnateTM W8 p otato. Compliance with Other Laws
CWA, CAA, EO s Fully compliant Fully compliant55

4 ENVIRONMENTAL CONSEQ UENCES

4.1 Environmental Consequences
This analysis of potential environmental consequences addresses the potential impact to the human environment from the alternatives analyzed in this EA, namely taking no action and a determination b y the agency that Simplot Innate TM W8 p otato does not pose a plant pest risk (Preferred Alternative)

. Potential environmental impacts from the No Action Alternative and the Preferred Alternative for Simplot Innate TM W8 p otato are described in detail throughout this section. A summary of potential environmental impacts is presented in Table 8 (Section 3.4, Comparison of Alternatives). A cumulative effects analysis is presented for potentially affected environmental concern s

. Certain aspects of this product and its cultivation would be no different between the alternatives: those instances are described below.

4.2 Scope of Analysis
Potential environmental impacts from the No Action Alternative and the Preferred Alternative for Simplot Innate TM W8 p otato are described in detail throughout this section. An impact would be any change, positive or negative, from the existing (baseline) conditions of the affected environment (described for e ach resource area in Section 2 ). Impacts may be categorized as direct, indirect, or cumulative. A direct impact is an effect that results solely from a proposed action without intermediate steps or processes. Examples include soil disturbance, air emissions, and water use. An indirect impact may be an effect that is related to but removed from a proposed action by an intermediate step or process. Examples include surface water quality changes resulting from soil erosion due to increased tillage, and worker safety impacts resulting from an increase in herbicide use

. A cumulative effects analysis is also included for each environmental issue. A cumulative impact may be an effect on the environment which results from the incremental impact of the proposed action when added to other past, present, and reasonably for eseeable future actions. Examples include breeding Simplot Innate TM W8 p otato with other deregulated events. If there are no direct or indirect impacts identified for a resource area, then there can be no cumulative impacts. Cumulative impacts are discus sed in Section 5.
Where it is not possible to quantify impacts, APHIS provides a qualitative assessment of potential impacts. Certain aspects of this product and its cultivation may be no different between the alternatives; those are described below.

Alt hough the preferred alternative would allow for new plantings of Simplot Innate TM W8 p otato to occur anywhere in the U

. S

. , APHIS will limit the environmental analysis to those areas that currently support potato production.56

4.3 Agricultural Production of Potato

4.3 .1 Acreage and Area of Potato Production

Acreage in potato production decreased in recent years, whereas potato yields increased dr amatically

. Potato acres harvested ranged between 1.0 and 1.5 million acres since 1951, with highs of 1.5 million in 1953, 1966 and 1967 and lows of 1.0 million in 2008, 2009 and 2010 in the U

. S

. ( USDA

- NASS, 2012b )

. Per

- acre yields, which averaged 397 cwt per acre in 2011 and 401 cwt per acre in 2012 increased eight

fold since the early 1900s and doubled since the early 1960s ( USDA

- NASS, 2013a )

. No Action Alternative: Acreage and Area of Potato Production USDA projects potato production will increase by 4.6% between 2012 and 2021 ( USDA, 2012 ) . Based upon historical trends in productivity, this increase in supply is unlikely to result in an increase in potato acreage. While harvested acreage has declined over the years, total production has increased ( Guenther, 2010b )

. Under the No Action alternative, agricultural land used for potato production will likely decline as potato production yield increases.
Preferred Alternative: Acreage an d Area of Potato Production If APHIS chooses th e P referred A lternative, the Simplot InnateTM W8 p otato e vent may become commercially available to the general public. Simplot Innate TM W8 potato is not expected to affect overall demand for potatoes, but g rowers who now purchase conventional varieties of Russet Burbank, Ranger Russet and Atlantic potato seed would have the option of purchasing the Simplot Innate TM W8 variety instead . With the traits of late blight resistance, reduced acrylamide potential, reduced black spot bruising , and lower levels of reducing sugars, the Simplot Innate TM W8 potato may replace other varieties of potato currently on the market, resulting in increased market share for the Simplot Innate TM W8 potato

. Simplot’s data demonstrate no differences in morphological characteristics and agronomic requirements between Simplot InnateTM W8 potato and other potato cultivars ( Simplot, 2014 ) and Simplot InnateTM W8 potato is not likely to change land acreage or any cultivation practices for potato production. It is expected that similar agronomic practices commonly utilized in commercially available pot ato cultivars would also be used by growers of Simplot InnateTM W8 potato. As described in the petition ( Simplot, 2014 ) , the agronomic char acteristics of the Simplot Innate TM W8 event are essentially the same as their conventional counterparts, and therefore would be grown in the same way as their conventional counterparts. The Simplot Innate TM W8 p otato event do es not possess traits that would allow them to be grown in areas other than those where their conventional counterparts are grown. T herefore, under the Preferred A lternative, acreage dedicated to potat o would remain about the same as in the No Action Altern ative.

4.3 .2 Agronomic Practices

No Act i on Alternative: Agronomic Practices If APHIS chooses the No Action alternative, general production practices are expected to continue as they are now.57

Preferred Alternative: Agronomic Practices The agronomic evaluation of the Simplot Innate TM W8 p otato event is summarized in Section 11 of the petition, with details provided in Section 11.1.3 ; analysis of disease susceptibility is presented in petition Section 11.2 ( Simplot, 2014 ) . Since all the Simplot Innate TM W8 p otato event is intended for fry and chip production, agronomic evaluations were conducted in geographically distinct sites that represent most of the main production areas for potatoes destined for fry and chip production in the U

. S

. ( Simplot, 2014 ) . The agronomic practices and pest control measures employed were location

- specific and typical for potato cultivation. They were recommended by both regiona l potato extension specialists and field agronomists including soil preparation, fertilizer application, irrigation, cultivation and pesticide

- based control methods. Events and untransformed varieties received identical inputs and treatments at each site. The following characteristics were eva luated over multi

- year trials: time to emergence, vigor, leaf size, leaf curl, vine maturity, disease susceptibility, insect damage, yield and specific gravity ( Simplot, 2014 )

. Simplot Innate TM W8 potato has been engineered to be resistant only to certain strains of one particular disease of potato, late blight. It is unknown whether this will lead to a reduction in frequency of fungicide application and volume for growers

. However, no other changes to current agronomic practices will be needed to grow the potatoes, thus the incorporated traits are not expected to affect agronomic practices other than potential reduction in fungicide use and volume ( Simplot, 2014 ; USDA

APHIS, 2014b )

. All events considered for deregulation were selected to exhibit comparable phenotypic characteristics to the control varieties when grown usin g standard industry practices.
Late Blight Resistance The Potato Late Blight Resistance Gene ( Rpi

- vnt1 ) encodes a resistance protein, VNT1, which reacts with a pathogen

- specific effector protein to halt the spread of infection ( Simplot, 2014 )

. Widel y consumed plant species that are reported to contain disease

- resistance (R) genes include the Solanaceae family, Zea mays (maize), Glycine max (soybeans), Oryza sativa L. (rice), and Triticum aestivum L. (common wheat) ( Bakker et al. , 2011 )

. In addition to these common cultivated crops, the Rpi

- vnt1 gene is identical to the Rpi

- phu1 gene ( Rodewald and Trognitz, 2013 ) found in some S. phureja species, a potato species consisting of many varieties which are currently consumed by indigenous people in South Amer ica. The presence of similar or identical genes in frequently consumed tomatoes and potatoes that have not had negative impacts on human health establish es a histo ry of safe use ( Simplot, 2014 )

.

Resistance to P. infestans occurs in many tuber

- bearing wild Solanum species that belong to the highly di verse section Petota Dumort. ( Vleeshouwers et al. , 2011 )

. Wild relatives of potato are a source of late blight resi stance genes ( Jones et al. , 2014 )

. To date, 21 R

- genes that confer differential resistance specificities to P. infestans isolates have been cloned from various Solanum species crops ( Vleeshouwers et al. , 2011 )

. Most Solanum R genes appe ar to have coevolved with P. infestans at its center of origin in central Mexico ( Vleeshouwers et al. , 2011 )

. Biochemical characterization and safety assessment of the VNT1 protein suggested a negligible risk associated with using VNT1 to confer late blight resistance to potato cultivars. The encoded VNT1 protein is native to Solanum species and provides protecti on against P. infestans , the causal agent of58

late

- blight disease. Currently VNT1 represents only one of 68 distinct R

- genes that have been characterized from wild Solanum specie s, which shows the breadth and importance of these genes to potato biology ( R o dewald and Trognitz 2013)

. Additionally, Simplot Innate TM W8 potato had less evidence of scab (as measured by mean percent lesion coverage of the tuber) than did the control line, and the lesions produced by the disease were less severe than in the control line. This result will be monitored in future field and storage studies to determine if this pattern of resistance to scab persists in commercial production ( USDA

- APHIS, 2014b )

. If so, this finding will improve the agronomic properties of Simplot Innate TM W8 potato for future development, but will not change the plant pest potential of the tuber.
In summary, there were no differences in disease susceptibility that would require additional treatments, nor did the potatoes have different nutrient requirement s that would alter fertilizer programs. Planting, cultivation, management and harvesting processes were not affe cted by the incorporated traits ( Simplot, 2014 )

. Field trials conducted by Simplot over multiple years showed no evidence for altered growth characteristics such as increased plant vigor, increased tuber set, early tuber sprouting, or delayed senescence

. In addition to observati ons on insect stressors, there were no trends observed with respect to significant differences in W8 potato responses to disease stressors in the 95 observations made, including bacterial and fungal pathogens. The only agronomic difference detected is tha t the W8 event is more resistant to late bligh t

. ( USDA

- APHIS, 2014b )

. Based on these analyses, i f APHIS chooses the preferred Alternative, there would be no expected differences in general agronomic practices than if the No Action alternative is chosen.

4.3 .3 Potato Seed Production

No Act i on Alternative: Potato Seed Production If APHIS chooses the No Action Alternative, potato seed production is expected to continue as it is currently.

Preferred Alte rnative: Potato Seed Production Since APHIS has determined that agronomic practices will be the same if the petition is approved ( USDA

- APHIS, 2014b ) , selection of the Preferred Alterna tive is not expected to result in any changes in potato seed production.

4.3 .4 Organic Potato Production
No Action Alternative: Organic Potato Production In the U

. S

. , only products produced using specific methods and certified under the USDA’s Agricultural Marketing Service (AMS) National Organic Program (NOP) definition of organic farming can be marketed and labeled as “organic” ( USDA

- AMS, 2010 ) . Organic certification is a process

- based certification, not a certification of the end product; the certification process specifies and audits the methods and procedures by which the product is produced.59

The organic sector is rapidly growing both in the US and the European Union (EU). Together, consumer purcha ses in thes e two regions made up 95 % of estimated world retail sales of organic food products in 2003 ( Dimitri and Oberholtzer, 2005 ) . In 2009, world retail sales of organic products were es timated to be on the order of $54.9 billion (USD), up from $50.9 billion in 2008 ( Organic Monitor, 2006 )

. If APHIS chooses the No Action Alternative, organic potato production is expec ted to continue, but trends in production may be affected by unpredictable variables such as d emand for both fresh and processed organic potatoes, overseas comp etition and production costs.
Preferred Alternative: Organic Potato Production Practic es Potato cultivar selection and breeding practices are similar between organic and conventional potato production. Risks to organic growers would be most likely to occur with accidental mixing of planting material or of potatoes in farming, transportation, or processing channels. These risks a re the same as those that organic growers already experience when keeping their organically grown potatoes separate from potatoes grown with conventional methods. Because potatoes are clonally propagated, the risk of affecting seed supplies through cross

- pollination is negligible. Organic farmers routinely plant organic seed potato material and any incidence of cross

- pollination in production fields will not affect the harvested potatoes.
If APHIS chooses the Preferred Alternative, organic growers would n ot be expected to modify production practices, and so no impacts to organic potato production would be expected.
Some organic potatoes are grown in the same areas as conventional potatoes and some are grown in more isolated regions. Based on USDA data, or ganic potato acreage from 1997 to 2008 showed a general increasing trend ranging from a low of 4,335 acres in 1997 to a high of 11,664 in 2007 ( USDA

ERS, 2009 )

. It is import ant to note that the current NOP regulations do not specify an acceptable threshold level for the adventitious presence of GE materials in an organic

- labeled product. The unintentional presence of the products of excluded methods will not affect the statu s of an organic product or operation when the operation has not used excluded methods and has taken reasonable steps to avoid contact with the products of excluded methods as detailed in their approved organic system plan ( Ronald and Fouche, 2006 ; USDA

- AMS, 2010 ) . However, certain markets or contracts may have defined thresholds ( Non

GMO

- Project, 2010 )

.

4.4 Physical Environment

4.4 .1 Water Resources

No Action A lternative: Water Resources The majority of potato production utilizes irrigation as a water source. As discussed in Section 2.2 .1, Water Resources, agricultural production can be detrimental to water quality by adding sediments from erosion via surface water, nutrient loading from fertilizers into groundwater , and pesticide runoff

.60

If APHIS chooses the No Action alternative , water usage for irrigation would be expected to continue. Supplemental irrigation may increase in some areas where potatoes have traditionally been grown with out irrigation . P otential for water quality impacts will continue.

Preferred A lternative: Water Resources No changes to agronomic practices which might affect water resources will be necessary to grow Simplot InnateTM W8 potatoe s

. Simplot’s studies demons trate no differences in morphological characteristics and agronomi c requirements between Simplot InnateTM W8 p otato and other potato varieties ( Simplot, 2014 )

. Again, as with the No Action Alternative, supplemental irrigation may increase in some areas where potatoes have traditionally been grown without irrigation, and potential for water quality impacts will continu e

. A determina tion of nonregulated status of Simplot InnateTM W8 potatoes is not expected to change the management practices currently employed for potato cultivation. Water quality impacts are ex pected to be the same under the Preferred Alternative as under the No Acti on Alternative.

4.4 .2 Soil Quality

No Action A lternative: Soil Quality Increased erosion potential of soil for potato production may result from fairly high tillage requirements, and the small amount of post

- crop plant material left in the soil. Cover crops are often planted to help mitigate this potential. Land management practices for potato production can affect soil quality. While practices such as tillage, fertilization, the use of pesticides and other management tools can improve soil health, the y can also cause substantial damage if not properly used. Several concerns relating to agricultural practices include increased erosion, soil compaction, degradation of soil structure, nutrient loss, increased salinity, change in pH, and reduced biologica l activity ( USDA

- NRCS, 2001 ) . Methods to improve soil quality include careful management of fertilizers and pesticides; use of cover crops to increase plant diversity and limit the time soil is exposed to wind and rain; and, increased landscape diversity with buffer strips, contour strips, wind breaks, crop rotations, and varying tillage practices ( USDA

- NRCS, 2006 )

. Living cover also protects against erosion, provides habitat and substrate for soil organisms, and increases soil organic residue inputs ( Doran et al. , 1996 )

. If APHIS chooses the No Action alternative, impacts on soil quality are expected to continue.

Preferred A lternative: Soil Quality A determination of nonregulated status for Simplot InnateTM W8 p otato is not expected to change the management practices currently employed for potato production. If APHIS chooses the Preferred Alternative, potential impacts on soil quality are expected to be similar to those under the No Action Alternative. Other studies of the effect of GE crops on soil characteristics have not shown significant effects. For example, Bruinsma ( 2003 ) found no differences in soil attributable to a GE potato cult ivar transformed to produce T4 lysozyme

. S implot’s studies demonstrate that agronomic characteristics and cultivation practices required for Simplot InnateTM W8 p otato production are indistinguishable from practices used to grow other potato varieties ( Simplot, 2014 )

. Except for the incorporated traits, the61

event is substantially equivalent to their conventional counterparts, thus no changes in plant/ soil interaction are expected.

I f APHIS chooses the preferred alternative, agricultural impacts on soil quality are expected to remain the same as they would if the No Action alternative is chosen.

4.4 .3 Air Quality

No Action A lternative: Air Quality

If APHIS chooses the No Action alternative , emissions associated with vehicles, fugitive dust particles and pestic ides are expected to continue.

Preferred A lternative: Air Quality

As discussed in Section 2. 2 .3 , Air Quality , emissions associated with crop production include vehicular emissions from the use of farm equipment, fugitive dust particles and releases of pesticides. Fugitive dust can arise from fields and unpaved roadways and can be generated by distu rbance of bare soil through vehicle traffic, harvesting operations or wind. These impacts are highly variable across potato growing regions and over time, depending on such factors as vehicle type, crop type, utilization of pesticides, method of applicati on, so il type and weather conditions. Simplot’s analyses presented in its petition ( Simplot, 2014 ) demonstrate that no changes to agronomic practices will be required to grow Simplot InnateTM W8 p otato. As discussed in Section 2.2 .3, Air Quality, agronomic practices that could affect air quality, such as soil preparation, cultivation, pesticide application and har vesting, were based on practices appropriate for each s ite, and were the same for the event and the controls. The results indicated that no changes from the site

- specific practices used for conventional varieties would be needed fo r production of the even t

. Therefore, if APHIS chooses the Preferred A lternative , impacts to air quality resulting from this action are expected to be the same as if the No Action alternative had been chosen.

4.4 .4 Climate Change

No Action Alternative : Climate Change

If APHIS selects the No Action Alternative, impacts to climate change are expected to continue.

. Preferred A lternative : Climate Change

T he range and area of U

. S

. potato production is not likely to change under the Preferred Alternative. As described in the Simplot petition ( Simplot, 2014 ) and APHIS PPRA ( USDA

- APHIS, 2014b ) , Simplot InnateTM W8 potatoes use identical management strategies to those for conventional potato production. Therefore, no changes are expected in agricultural activities that might affect climate change, such as machine usage and fertilizer application. Collectively, beca use the range, area, and agronomic practices of potatoes are unlikely to change following a determination of nonregulated status of Simplot InnateTM W8 p otato , the agricultural impacts of potato production on climate change are also unlikely to change under the Preferred Alternative.62

4.5 . Biological Resources

4.5 .1 Animal Communities

No Action Alternative: Animal Communities

If APHIS chooses the No Action A lternative , animal communities living both within and outside of potato fields are expected to continue to experience impacts similar to the current impacts of agriculture. Animals living in or near agricultural fields a re the most likely to be affected by crop production, including aquatic communities, which may be affected by sedimentation and turbidity from e rosion, or by pesticide runoff.

Preferred Alternative: Animal Communities

N o changes in land use are expected if APHIS chooses the preferred a lternative. In addition, the evaluation presented in the petition ( Simplot, 2014 ) demonstrates that changes in agronomic practices, including practices related to pesticide use and erosion mitigation , are not required for production of Simplot InnateTM W8 p otato

. The W8 event has not been modified to exhibit any pesticidal activities and do not contain pesticide

- expressing genes. No differences were observed for insects or other animals interacting within the potato ecosystem during the field t rials, leading to the conclusion that the Simplot InnateTM W8 potatoes would have the same impact on other organisms as conventional potatoes ( Simplot, 2014 )

. Aside from the targeted traits, the Simplot Innate TM W8 potato is compositionally similar to conventional potatoes ( Simplot, 2014 ; USDA

- APHIS, 2014b )

. APHIS reviewed Simplot’s data on field trials ( USDA

- APHIS, 2014b ) and impacts by insects, and concluded that Simplot InnateTM W8 p otato would suffer no greater insect pressu re than conventional potatoes ( USDA

- APHIS, 2014b )

. For example, no increase in aphid infestation or damage was reported in t he field observations for the Simplot InnateTM W8 p otato event ( Simplot, 2014 )

. In addition, since potatoes are propagated vegetatively from seed potato tuber pieces, pollination by bumblebees is not impor tant to potato tuber production.
Simplot Innate TM W8 contains traits for reduced acrylamide formation, reduced black spot bruise, lowered reducing sugars, and late blight resistance. Acrylamide only forms after cooking potatoes at high heat , so this toxi c compound is not expected to be a concern for herbivores. Consumption of PPOs by animals would still occur. Phenols occur in wide distribution of plants ( Felton et al. , 1989 ) , but their biological function of remains unclear ( Bachem et al. , 1994 ; Mayer, 2006 )

. The oxidation products of PPO appear to play a role in general plant defense mechanisms against pathogens and pests

. The relationship between PPO and resistance to herbivores has also been studied. PPO activity increases when potato leaves are wounded and at higher rates in response to regurgitant from the pest Colorado potato beetle ( Kruzmane et al. , 2002 )

. In other plants, the increase of PPO activity is a direct induced defense against insect pests that decrea ses nutrient availability ( Baldwin and Preston, 1999 ; Partington et al. , 1999 ) . In addition, PPO in glandular trichomes of wild potatoes (and othe r plants) is involved in resistance to insects ( Plaisted, 1980 ; Steffens, 1994 ) . However, the trichom es of cultivated potatoes contain low amounts of PPO which is not thought to be involved in resistance to pests ( Friedman, 1997 )

. Phylogenetic surveys of PPO in land plants shows that the gene family has undergone evolutionary expansion in some plant families, but is reduced or absent in others, which suggests that PPO function is63

probably diverse ( Tran et al. , 2012 )

. PPO has also been implicated in other functions such as buffering of plastid oxygen levels, wound healing, and chloroplast metabolism ( Steffens, 1994 )

. In potato, PPO is also involved in black spot bruise formation, which reduces the quality of harvested tubers ( Bachem et al. , 1994 ; Corsini et al. , 1999 ; Partington et al. , 1999 ) . These dark

- pigmented polyphenols, also referred to as melanins, result in the darkening of potato tissue following m echanical bruising ( Thy gesen et al. , 1995 )

. Ppo5, the PPO gene silenced in W8 is the primary form found in potato tubers, and is the primary PPO gene detected in older tubers ( Thygesen et al. , 1995 ) . Ppo5 transcripts were down

- regulated in tubers, but not in stems, roots, leaves and fl owers in W8 compared to the non

- transgenic control varieties ( Simplot, 2014 )

. This suggests that except for tubers, Simplot InnateTM W8 p otato is expected to be unchanged relative to PPO gene expression and PPO levels in leaves , and therefore unchanged in any potential interactions between potato foliar PPO and foliar pathogens or pests. No consistent differences were observed in foliar pe st and pathogens on Simplot potatoes compared to their control varieties ( Simplot, 2014 ; USDA

- APHIS, 2014b )

. Simplot assessed nema tode damage of Simplot InnateTM W8 potato , and results showed no more nematode damage than in control potatoes ( Simplot, 2014 )

. Osman et al. ( 2012 ) suggest that PPO might be involved in resistance to some plant parasitic nematodes, but do not provide data demonstrating such a role or address the species that affect potatoes. Conversely, lower PPO levels might increase the resistance of Simplot InnateTM W8 p otato to some nematodes. Other researchers found that tubers of potato cultivars resistant to the potato cyst nematode, G lobodera pallida , have lower levels of phenols and discolored less than tubers of susceptible cultivars ( Mondy et al. , 1985 )

. They suggest that PPO

- mediated tanning of nematode cysts enables eggs to remain viable in soil for a longer time. Lyon ( 1989 ) reviewed the biochemical basis for resistance of potato to bacterial soft rot caused by Erwinia spp. Because it is the dominant monophenol, chlorogenic acid has been a focus in many of these studies. Chlorogenic acid did not inhibit the in vitro growth o f Erwinia spp. or P. infestans (the causal agent of late blight), and there remains no proof that phenols are important in the interaction between potato and Erwinia spp. ( Lyon, 1989 )

. Kroner and Marnet ( 2012 ) evaluated the role of specific phenolics in quantitative resistance to two pathogens, P. infestans , the causal agent of late blight, and Pectobacterium atrosepticu m (synonym: E. carotovora subsp. atroseptica ), the causal agent of bacterial soft rot. Increasing concentrations of total phenolics tended toward a positive correlation with quantity of symp toms due to the late blight pathogen, but were negatively correlated with increased tuber rot severity due to the soft rot pathogen. Because chlorogenic acid accumulates in response to soft rot elicitors, these authors suggest that chlorogenic acid could be used as a marker for resistance to soft rot ( Kroner and Marnet, 2012 ) . Since chlorogenic acid is a PPO substrate, silencing of PPO would not be expected to reduce the level of chlo rogenic acid in potato tubers.
Although animals would not be expo sed to acrylamide, Simplot I nnateTM W8 p otato tubers contain increased levels of glutamine ( Simplot, 2014 ) because the enzyme aspara gine synthetase also functions to deaminate glutamine to glutamate ( Lam et al. , 1996 )

. In all of the field trials tested by Simplot, these differences were within the 99% tolerance intervals generated from nine non

- GE commercial control potato varieties grow n concurrently at the same field sites ( USDA

- APHIS, 2014b )

. Souba ( 1991 ) noted that in mammalian cells, glutamine acts as a nitrogen donor for the biosynthesis of important compounds su ch as nucleotides and amino acid

. Consumption of increased glutamine has been tested64

by some researchers. For example, Wang et al. ( 2008 ) reported that intestinal dysfunction and atrophy were prevented when piglets’ diets were s upplemented with glutamine. Similarly, Boukhettala et al. ( 2010 ) showed that adding glutamine to rat diets reduced injury to the intestinal mucosa following a course of chemotherapy , and Klimberg et al. ( 1990 ) demonstrated that added glutamine protects rat intestinal mucosa following radiation therapy.
There were no significant d iffe rences between the event and its respective control varieties for mean glycoalkaloid toxin content , and levels were below the accepted safety limit ( Simplot, 2014 )

. In its petition , Simplot ( Simplot, 2014 ) assessed susceptibility of Simplot Innate TM W8 potat o to several diseases, and showed that the potato is resistant to late blight without any change in susceptibility or loss of resistance to other diseases. Because of the specificity of the Rp i

- vnt1 protein in Simplot Innate TM W8 potato, and the observed disease susceptibility panel, the Simplot Innate TM W8 potato is highly unlikely to adversely impact soil or plant

- associated fungi or bacteria ( USDA

- APHIS, 2014b )

. Potato Late Blight Resistance Gene ( Rp i

- vnt1 ) e ncodes a protein that halts the spread of the infection by the pathogen. The mechanism of action for the expressed effector protein is very specific and extremely unlikely to impact other organisms such as insects and other non

- target organisms ( Simplot, 2014 )

. There is no evidence that animal exposure to Simplot InnateTM W8 p otato would have any effect or be any less attractive as food, refuge, cover and nesting sit es as non

- GE varieties of potatoes

. Simplot Innate TM W8 potato tubers are nutritionally and compositionally similar to the respective parental control and other commercial potato varieties with the exception of the inte ntional changes conferred by the introduced or silenced genes ( USDA

- APHIS, 2014b )

. The results of the beneficial arthropod and pest arthropod abundance monitoring produced no significant differences between the Simplot Innate TM W8 event and the control for any of the arthropods collected ( USDA

- APHIS, 2014b ) . APHIS concludes that exposure to and/or consumption of Simplot Innate TM W8 tubers or other plant parts is unlikely to have adverse impacts on organisms beneficial to agriculture ( US DA

- APHIS, 2014b )

. Accordingly, based on the results of the studies presented here, it seems unlikely that the VNT1 protein will have any impact on human health through allergenicity or toxicity, or any environmental impacts to

non

- target mammals, birds, fish, or insects due to the low expression and lack of toxic effects of the protein. There is negligible risk of environmental contamination and no persistence in the environment because of the low expression of the VNT1 protein in potato tubers. The prevalence of similar resistance genes throughout edible crops suggests that extremely low levels of similar proteins are widespread in nature and unli kely to pose risk to human health, non

- targets or the environment ( USDA

APHIS, 2014b ) . The introduced genes did not significantly alter the observed insect pest infestation and disease occurrence or resulting damage in Simplot InnateTM W8 potato relative to the control line under the typical recommended pest management conditions. Therefore, APHIS concludes that based on the compositional similarity of Simplot Innate TM W8 potato tubers to the parent v arieties, the observed interactions of Simplot potatoes with insects and pathogens, and the unlikely impacts of nontarget effects due to RNAi, that the consumption of or indirect exposure to Simplot tubers or other plant parts is unlikely to have adverse i mpacts on animals in or near potato fields ( USDA

- APHIS, 2014b )

. In general, migratory birds are not expected to feed on potato plants because of their glycoalkaloid content, while cover and nesting site s also appear comparable to conventional varieties because the GE plants are agronomically similar

. Considering all that is known about Simplot InnateTM W8 potato lines65

and their production, there is nothing to indicate that migratory birds would interact or be affected any differently than they would with other potato varieties currently grown.
With regard to non

- target organisms such as insects, birds or mammals, consumption of Simplot InnateTM W8 potato is unlikely to substantially affect them. Simplot ’s data demonstrates that the composition of Simplot InnateTM W8 potato does not substantially differ from conventional potato varieties ( Simplo t, 2014 )

. The literature contains reports of exposure of transgenic organisms to non

- target organisms, although there have been no studies done with Simplot Innate TM W8 potato. Exposure may occur via feeding on the roots of GE plants or eating plant pa rts or exudates produced by GE plants ( Cowgill et al. , 2002 )

. No detec table eff ects have been found in studies of soil organisms (microorganisms and fungi) ( Celis et al. , 2004 ; Milling et al. , 2004 )

. Variables other than the genetic modification and its associated production of transgenic proteins were found to be responsible for any changes in soil populations. For example, soil type and texture had the most effect on bacte rial communities; the availability and amount of organic carbon in soils greatly influenced activity and structure of bacterial communities; and host plant genotype and developmental stage contributed to any community changes ( Rasche et al. , 2006 ) . The effects due to the genetic changes were found to be either transient or minor compared to other factors. A study on the effect of GE potatoes on invertebrates showed that the potato did not influence the density or nu mber of soil nematodes in the soil ( Celis et al. , 2004 )

. APHIS did not identify any significant changes to agricultural or cultivation practices (e.g. pesticide applications, tillage, irrigation, harvesting, etc.) that would result fro m adoption of the GE crop; therefore, no impact on plant diseases or pests or their management is likely to occur ( USDA

- APHIS, 2014b )

.

4.5 .2 Plant Communities

No Action Alternative: Plant Communities If APHIS selects the No Action Alternative, impacts to plant communities as a result of potato production are expected to continue.

Preferred Alternative: Plant Communities Simplot has presented the results of field trials which demonstrate that Simplot I nnateTM W8 potatoes do not require any changes to agronomic inputs when compared with conventional potatoes ( Simplot, 2014 )

. There would b e no change in herbicide use or patterns. Under the Preferred Alternative, potential impacts to plant communities are not anticipated to be different compared to the No Action Alternative.
The silencing of the gene responsible for asparagine synthesis and thus the lower acrylamidepotential leads to somewhat heightened levels of glutamine in Simplot InnateTM W8 potato , but levels are within acceptable limits ( OECD, 1997 )

. In the very unlikely event of hybridization of Simplot Inn ateTM W8 potato, resu lting progeny may have altered levels of asparagine. Plants use asparagine as a nitrogen source when they are unable to store nitrogen in the form of protein , and can accumulate to very high concentrations ( Halford et al. , 2012b )

.66

As discussed in Section 4.5 .1, Animal Communities , consumption of Simplot InnateTM W8 p otato is not expected to change herbivore

- plant interaction s.
Land use and agricultural production of potatoes under the Preferred Alternative is likely to continue as currently practiced. Consequently, any impact to plant communities as a result of potato production practices under the Preferred Alternative is the same as the No Action Alternative.

4.5 .3 Gene Flow and Weediness

No Action Alternative: Gene Flow and Weediness If APHIS selects the No Action Alternative, there would continue to be little problem with gene flow or weediness for potato.

Preferred Alternat ive: Gene Flow and Weediness If APHIS selects the Preferred Alternative, no changes in agronomic practices are expected to occur ( USDA

- APHIS, 2014b ) which might make potato, including Simplot InnateTM W8 p otato more susceptible to gene flow or weediness.

As discussed in Section 2.3.3, Gene Flow and Weediness, Russet Burbank potato is sterile and produces few flowers ( PAA, 2013 ) . Fertile varieties of potato pose little potential for outcrossing because of their lack of nectar and therefore attractiveness to honey bees ( OECD , 1997 ) and their self

- pollinating biology ( Gillund et al. , 2013 ) . Hybridization potential is nil because of these factors and because commercial potatoes do not exhibit weedy characteristics ( Love, 1994 ) . There are few wild potato varieties in the US, and of those, most are geographically isolated from commercial production areas ( US

- EPA, 2011b )

. The data presented by Simplot demonstrate that the Simplot Innate TM W8 potato is phenotypically and agronomically similar to its Russet Burbank parent variety and do es not exhibit meaningful changes in characteristics that would make them weedier or more persistent than the parent variety. In fact, because of its reduction in early emergence and large tub er yield, the Simplot Innate TM W8 potato appear s to have a reduced potential for weediness ( USDA

- APHIS, 2014b )

. Furthermore, Simplot did not observe any differences during the completed post

- harvesting volunteer monitoring of the Simplot Innate TM W8 potato fiel d test sites from 2 years of field testing that would lead them to conclude that these potatoes have properties that would increase their survivability compared to conventional potatoes ( Simplot, 2014 )

. With respect to gene flow, t he genetic modification in the Simplot Innate TM W8 potato is not expected to increase the potential for gene flow ( USDA

- APHIS, 2014b ) compared to the nontransgenic recipient or other varieties of the crop commonly grown. Gene flow from Russet Burbank Event W8 is nonexistent b ecause the variety is sterile ( PAA, 2009 )

. The late blight resistance gene, Rpi

- vnt1 , encode s a resistance protein, VNT1, which reacts with a patho gen

- specific effector protein to halt the spread of infection. This resistance would not enhance the potato survivability beyond what would be normally expected for potatoes. Therefore, Simplot Innate TM W8 potato is unlikely to be any w eedier than conventional potato ( USDA

- APHIS, 2014b )

. 4.5 .4 Microorganisms67

No Action Alternative: Microorganisms If APHIS chooses the No Action A lternative , potato crop interactions with microorganisms are e xpected to remain the same over time

. Preferred Alternative: Microorganisms
Under the Preferred Alternative, the impacts to microorganisms are expected to be the same as if the No Action Alternative is chosen. T he evaluation presented in the petition ( Simplot, 2014 ) demonstrates that changes in agronomic practices, including practices related to soil preparation (which may impact soil organic mate rial and pH) and to pesticide application (which may directly impact microorganisms), would not be required for production of the Simplot Innate TM W8 p otato event ( USDA

- APHIS, 2014b )

. Tuber browning can b e a plant response to infection by microbial pathogens, so modified potato tubers may not exhibit the same degree of symptoms as conventional varieties. Plant infection can also induce the production of other compounds that produce browning (e.g. phenolic s) so a complete absence of symptoms in GE varieties is unlikely ( USDA

- APHIS, 2014b )

. If there are no disease symptoms, or if symptoms are reduced below action thresholds, then it is unlikely a farmer would increase pesticide use.
A safety assessment of mice fed a diet of GE non

- browning potatoes showed no adverse effects in mouse gut micr obiota ( Llorente et al. , 2011 )

.

4. 4.5 Biodiversity
No Action Alternative: Biodiversity

If APHIS chooses the No Action alternative , increases in potato productivity are expected to continue to offset increased demand, resulting in a fairly constant acreage devoted to potato production in the country. This will allow for continued trends of biodiversity occurring outside the borders of agricultural fields even though b iodiversity. Biodiversity is expected to continue to be fairly low within agricultural fields.
Preferred Alternative: Biodiversity Under the Preferred Alternative, biodiversity is unlikely to be substantially changed in comparison to the No Action Alternative. First, t he evaluation presented in the petition ( Simplot, 2014 ) demonstrates that changes in agr onomic practices would not be required to incorporate production of the event

. This

means cultivation, management, and land

- use decisions related to Simplot InnateTM W8 potatoes are not different from conventional potato cultivars

. With the possible exception of fungicide application and volume , which may remain the same or decrease because of the late blight resistance trait, a gronomic practices such as irrigation, pesticide application , fertilizer applications , and agriculture equipment would be un changed by the addition of these two varieties

. Thirdly, flora and fauna t hat typically inhabit potato fields will continue to be affected by currently used management plans and production systems. The consequences of current agronomic practices associat ed with potato production on the biodiversity of plant and animal communities are unlikely to be altered.
Consequently, any impact to biodiversity as a result of potato production practices under the Preferred Alternative is likely to be identical to the N o Action Alternative.68

4.6 Human and Animal Health

4. 6

. 1 Human Health

Potato is primarily gr own for human consumption. U

. S

. per capita potato consumption is approximately 112 pounds per year. Of this, approximately 65 pounds is used for frozen fries or chips. Per capita consumption data are shown in Table 6. As discussed in Section 2. 4

. 1 , Consumer Health, potential toxins in potatoes are acrylamide , which forms subsequent to high

- temperature cooking, and glycoalkaloids. P atatin is allergen ic to a very small percent age of children.

No Action Alternative: Human Health Under th e No Action alternative, consumption of potatoes would be expected to continue at the same rate as currently . Consumers will continue to be exposed to similar levels of acrylamide in cooked potatoes if other methods are not employed to reduce levels. Glycoalkaloids would be expected to remain at sufficiently low levels such that health impacts would not occur. Patatin would remain a

co ncern for allergic individuals

. Preferred Alt ernative: Human Health

If APHIS chooses the Preferred Alternative , and Simplot InnateTM W8 p otato is widely adopted , acrylamide content in cooked potatoes c ould be significantly reduced, leading to potential health benefits for consume r s. Compared with con ventional potatoes, Simplot InnateTM W8 p otato contains, on average, 78

- 84 % less acrylamide when cooked ( Simplot, 2014 )

. As discussed in S ection 2. 4

. 1 , Consumer Health, the State of California listed acrylamide as a potential carcinogen under Proposition 65 in 1990 and established a No Significant Risk Level (NSRL) of 0.2 μg/day ( CEPA

- OEHHA, 2005 ) , which was later revised to 1.0 μg/day ( CEPA

- OEHHA, 2005 )

. The FDA is considering issuing guidance concerning safety of acrylamide ( FDA, 2009 ) , and in 2013, published recommendations ( FDA, 2013c ) that health

- conscious consumers may want to avoid the consumption of fried potato products

. E specially since American consumption of French fries is high ( USDA

- NASS, 2012c ) , these developments regardin g acrylamide safety may lead to processor preference for Simplot InnateTM W8 p otato in French fries and other frozen potato products. In the absence of these alternative varieties, food producers voluntarily alter their production practices to reduce acrylamide in their products. Deployment of Simplot Innate TM W8 potato genes would allow them an alternative way to produce reduced acryla mide products.
The lowered reducing sugar trait will also potentially lead to improvements in human health due to its ability to decrease acrylamide formation potential even further.
The late blight resistance gene will likely improve potato yield, and w ill indirectly improve human health by increasing food availability.

T he data presented in the petition shows that the Simplot InnateTM W8 p otato event is at least as safe and nutritious for food as the untransformed controls ( Simplot, 2014 )

. The compositional analyses of the event is summarized in the petition, with detailed results in Section 8 ( Simplot, 2014 )

. The compositional assessments determined the amounts of 1) moisture, protein, total fat, ash, crude fiber, carbohydrate and calories; 2) vitamins B6, B3 and C; 3) mi nerals copper, magnesium and potassium; 4)69

glycoalkaloids; 5) free amino acids; and 6) total amino acids for tubers collected from events grown in 2012 and 2013 in potato

- gr owing areas of the U

. S

. Observed changes in asparagine and reducing sugars accompl ished through transformation of various potato varieties resulted in lower acrylamide levels in French fries and potato chips. These modifications did not alter the quality of potato as food because all results fell within normal ranges for potato. In ad dition, the research confirmed that glycoalkaloid levels were unchanged compar ed with the control varieties.

Based o n the results in results in the petition ( Simplot, 2014 ) , t h e potato event described in this petition do es not appear to be compositionally different in compar ison to untransformed controls, except for the intended traits. Therefore, issues with allergies are not expected to differ from those in the currently affected environment or un der the No Action alternative. The National Academy of Sciences (NAS) has ranked methods of genetic modification according to the relative likelihood of unintended effects, such as the increase i n a plant’s production of certain allergens. The NAS considered methods that involve recombinant DNA via Agrobacterium transfer of genes from closely related species (the Simplot InnateTM method used to produce this event is one such method that does not i nvolve the transfer of genes) to be among the methods least likely to have unintended effects

– less likely than conventional pollen

- based crossing of closely related species

– and far less likely than methods such as ionizing radiation and chemical mutage nesis, which are not subject to regulation and are not excluded methods under the NOP ( Sciences, 2004 )

.

4. 6

. 2 Worker Safety
No Action Alternative: Worker Safety

If APHIS were to choose the No Action alternative , farm and food production workers would continue to be exposed to the same types and amounts of hazards as they currently experience in potato production and food processing

. Preferred Alternative: Worker Safety
Under the Preferred Alternative, t here will be no changes in agronomic or food production practices in order to produce food and feed from Simplot InnateTM W8 p otato ( Simplot, 2014 )

. C onsequently , impacts to worker health resulting from approval of the petition are expected to be the same as if the No Action A lternative is chosen.
Simplot demonstrates in its petition that the agronomic inputs required to cultivate Simplot Innate TM W8 p otato are functionally equivalent to those required for conventional potatoes ( Simplot, 2014 )

. Current health and safety protocols are not likely to require changes to accommodate the production or handling of Simplot InnateTM W8 potatoes because the characteristics of the potatoes are not altered. Normal harvesting, transport, and storage conditions designed to minimize the accumulation of gl ycoalkaloids and acrylamide do not need to be altered to accommodate these potato varieties. Sin ce fungicide use should re main the same or decrease, but should not increase , workers should be exposed to no more than pesticides than under the No Action Alternative

.70

4. 6

. 3 Animal Feed

No Action Alternative: Animal Feed

As discussed in Section 2. 4.3 , Animal Feed , a small portion of the potato crop and waste from processing are sold as livestock feed. If APHIS selects the No Action A lternative , a small percent of the potato crop would continue to be used for livestock feed.

Preferred Alternative: Anim al Feed
The compositional analyses of the Simplot Innate TM W8 event is summarized in Section 8 of the petition, with detailed results in Section 8 ( Simplot, 2014 )

. Additionally, the nutritional and compositional differences between Simplot Innate TM W8 potatoes and conventional potatoes w ere evaluated in the PPRA ( USDA

- APHIS, 2014b ) and found to be similar

. The composition of Simplot Innate TM W 8 potatoes is within the ranges of normal variation with conventional potatoes with respect to protein and carbohydrate content available in feed ( USDA

- APHIS, 2014b )

. As a result, incorporation of Simplot Innate TM W8 potatoes into animal feed is unlikely to affect palatability of the feed

. In conclusion, the data presented in the petition sho ws t hat potatoes from the event are as safe and nutritious for feed as the untransformed controls, and if APHIS were to choose the Preferred A lternative , the use of potatoes as livestock feed would be no different than if the N o Action A lternative was chosen.

4. 7 Socioeconomic Impacts

4. 7 .1 Domestic Economic Environment

No Action Alternative: Domestic Economic Environment The domestic economic environment is discussed in Section 2. 5.1 , Socioeconomic: Domestic Economic Environment

, and potato utilization in t he country is summarized in Table 8 . Potatoes are grown on approximately 1.1 million acres in the U

. S

. , with an annual value of approximately $3.5 billion. Major products include fresh potatoes, frozen fries and chips. Organic potatoes account for less than 1% of the market.

If APHIS chooses the No Action alternative , domestic potato production, including organic production, is expected to continue at rates similar to the present. The USDA projects an approximate 4.6% increase in production between 2012 and 2021 ( USDA, 2012 )

.
Preferred Alt ernative: Domestic Economic Environment If APHIS chooses the P referred A lternative, the Simplot Innate TM W8 p otato event will become available for commercial production. Because of the reduced potential for black spot bruise of Simplot InnateTM W8 p otato , wastage is expected to decrease . This will lead to greater efficiency in processing, and an improved revenue s tream for product producers

. Overall, if APHIS chooses the Preferred Alternative, the introduction of Simplot InnateTM W8 potato are likely to have positive economic impacts on potato growers that choose to grow Simplot InnateTM W8 potato.71

Potatoes with low acrylamide potential , reduced black spot bruise , lowered reducing sugars, and late blight resistance are expected to have higher market value for the same inputs, representing potential increased revenue for growers and processors, and an overall increase in the value of potato production. The initial crop introduction will build up slowly as seed becom es available and will be controlled within existing processing channels to ensure that potatoes enter only the intended markets. This will provide a period of time to assess consumer acceptance and to address grower and industry

concerns. A limited intro duction that is initially in a vertically integrated supply chain will be well controlled by grower and processor agreements. In this situation, conventional products will be considered “identity preserved” with respect to the well

- controlled st ewardship of the potato event and its products. As adoption of the potato event increases, programs for identity preservation will be implemented as needed. It is expected that development and implementation of identity preservation systems will add some cost to t he supply chain; the total costs will depend upon the type and extent of market penetration ( Simplot, 2014 )

. Organic potato growers are no t anticipated to incur additional operating costs to as a result of the Preferred Alternative. See Section 4. 3.4 , Organic Potato Production, for further discussion.

Cold

- induced sweetening and the resulting potential for acrylamide formation is addressed by the suppression of the Vlnv gene ( Bhaskar et al. , 2010 ) in Simplot Innate TM W8 potato. The VInv gene silenc ing cassette in pSIM1678 resulted in decreased levels of vacuolar invertase, an enzyme which converts sucrose into glucose and fructose. When levels of invertase are decreased in potatoes, reducing sugars glucose and fructose remain at low levels during storage while sucrose increases,

e specially when held below typical storage temperatures of 46

- 48°F for French fry potatoes. Before testing for invertase activity, tubers were stored at 39°F for one month. Three replicates for each of Simplot Innate TM W8 and Russet Burbank control were used for the assay which was measured by the accumulation of glucose. Simplot Innate TM W8 tubers had a n 85% reduction in vacuolar invertase activity in cold

- stored tubers compared to control s

. The reduced vacuolar invertase activity in W8 tubers is

assoc iated with reduced RNA accumulation from the VInv gene and lower levels of reducing sugars glucose and fructose ( Simplot, 2014 )

. All Simplot Innate TM W8 tubers contained more sucrose than control samples at harvest and after multiple storage time points at both 38 ̊F and 46 ̊F. The increase in sucrose was expected from silencing the VInv gene, thus inhibiting the conversion of sucrose int o the reducing sugars glucose and fructose. The mean levels of sucrose for W8 were within the tolerance interval and combined literature ranges, and therefore would be considered substantially equivalent to the controls. Human c onsumption of potato with increased sucrose levels would be digested by humans into fructose and glucose ( Combes and Monsan, 1983 )

. By silencing vacuolar invertase in potato, growers should be able to store pota toes destined for processing at significantly lower temperatures, decreasing loss from disease and yield losses from higher respiration rates related to typical storage at 46

– 48  ̊F. ( Simplot, 2014 )

. Storage at lower temperatures may provide other advantages such as disease reduction, minimization of moisture loss, and reduction of anti

- sprouting chemicals ( Simplot, 2014 )

. For the Russet Burbank event Simplot Innate TM W8 potato , there should be significant economic and quality benefits from lower levels of reducing sugars. In addition, less reducing sugar will result in lower72

levels of acrylamide after cooking, a significant advantage considering the health concerns associated with acrylamide ( NTP, 2012 ; FDA, 2013a )

.

4. 7 .2 Trade Economic Environment

As discussed in Sec tion 2. 5.2 , Trade Economic Environment , the U

. S

. exports more than $1 billion in potato products annually, primarily consisting of frozen fries and other processed potatoes. Demand from Canada, Mexico , and Asia is driving growth in exports. Japa n is the largest market for US exports of frozen potatoes, w hile Canada is the largest US export market for chips and fresh potatoes. The US also has substantial imports of potatoes and potato products from Canada and Mexico ( USDA

- ERS, 2012a )

.
No Action Alternative: Trade Economic Environment If APHIS chooses the No Action alternative , U

. S

. potato exports are expected to continue as affected by market forces

. Preferred Alternative: Trade Economic Environment

If APHIS chooses the preferred alternative , U

. S

. potato exports are expected to continue as affected by market forces . Approval for the event will be sought in Canada, Japan and Mexico ( Simplot, 2014 ) prior to commercial pr oduction beginning in the U

. S

. Previous recalls of potato products that were shipped to Japan and then found to contain genetically modified material we re related to unap proved events. Japan has zero tolerance for unapproved events ( Reuters, 2001 )

. To assist in the prevention of trade disruptions, as has been experienced with other potato events, international approvals will be pursued from key trading partner countries prior to beginnin g commercial production in the U

. S . These approvals should ensure continued trade with key export markets. Simplot intends to follow the recommended stewardship policy statement released by the Biotechnology Indu stry Organizati on in May 2007: To help ensure the continued adoption of agricultural biotechnology globally and to continue to have products of agricultural biotechnology bring value to the marketplace, BIO’s Food and Agriculture Section supports actions that facilitate the flow of goods in commerce and minimize trade disruptions. BIO’s Food and Agriculture Section believes that henceforth individual member companies should, prior to commercialization meet applicable regulatory requirements in key countries identified in a market and trade assessment that have functioning regulatory systems and are likely to import the new biotechnology

- derived plant products. The voluntary guideline was adopted because, according to BIO “asynchronous authorizations combined with importin g countries maintaining ‘zero tolerance’ for recombinant

- DNA products not yet authorized results in the potential for major trade disruptions. The potential occurrences of trade disruptions will only increase given the substantial amount of research that will bring many new products and combinations of products to market.”

In comparison to some biotech crops, the Simplot Innate TM W8 p otato is expected to be viewed more favorably by regulatory organizations due to the lack of pesticidal traits and marker

- fre e transformation methods . For these reasons, it is anticipated to pose fewer im plications for export markets.73

If APHIS chooses the Preferred A lternative , as with the domestic economic environment, the introduction of this potato event may have positive economic impacts on export markets, recognizing that some addi tional costs could be incurred.

5 CUMULATIVE IMPACTS
A cumulative impact may be an effect on the environment which results from the incremental impact of the proposed action when added to other p ast, present, and reasonably foreseeable future actions. For example, the potential effects associated with a determination of nonregulated status for a GE crop in combination with the future production of crop seeds with multiple deregulated traits (i.e. , “stacked” traits), including drought tolerance, herbicide tolerance, and pest resistance, would be considered a cumulative impact.
Regulations promulgated by the Council on Environmental Quality (CEQ) under the National Environmental Policy Act (NEPA) de fine cumulative impact as “the impact on the environment which results from the incremental impact of the action when added to other past, present and reasonably foreseeable future actions” (40 CFR 1508.7). For example, the potential effects associated wi th a determination of nonregulated status of a GE crop in combination with the future production of crop plants with multiple traits that are no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the PPA, includ ing disease tolerance, nitrogen utilization, and herbicide tolerance, would be considered a cumulative impact.

5.1 Assumptions Used for Cumulative Impacts Analysis

Cumulative effects are qualitatively analyzed for each environmental issue assessed in Secti on 4, Environmental Consequences by focusing on the Preferred Alternative in consideration of related activities including past, present and reasonably foreseeable future actions including the production of potato progeny . In this analysis, if there are n o direct or indirect impacts identified by a resource area, then APHIS assumes there can be no cumulative impacts in that area

. APHIS considered the potential for Simplot InnateTM W8 p otato to extend the range of potato production and affect the conversion of land to agricultural purposes. Simplot’s studies demonstrate that agronomic characteristics and cultivation practices required to produce Simplot InnateTM W8 p otato are indistinguishable from practices used to grow conventional potatoes ( Simplot, 2014 ; USDA

- APHIS, 2014b )

. This implies its cultural requirements would neither differ from other potatoes nor change the areas where potatoes are currentl y grown. If the petition is approved, Simplot InnateTM W8 p otato could replace other commercially available potato cultivars, without requiring production o n new, previously

non

- cropped land. L and use changes associated with approving the petition do not appear to be any different than those associated with conventional potato production. APHIS focused the analysis of cumulative impacts on the areas in the U

. S

. that currently produce potatoes. Potential reasonably foreseeable cumulative effects are analyzed under the assumption that some growers have used commonly accepted best management practices (BMPs) in the past , and would continue to use these practices when reasonable under the circumstan ces for their chosen system and74

cultivars during potato production. APHIS recognizes, however, that not all growers choose to use the

same BMPs.
5.2 Past and Present and Reasonably Foreseeable Actions
The Preferred Alternative is not expected to directly cause a measurable change in agricultural acreage or area devoted to potato production in the U

. S

. The analysis showed Simplot InnateTM W8 p otato is a potato cultivar that is agronomically and compositionally similar to other commercially available potato cultivars, so it is expected that Simplot InnateTM W8 p otato would replace other similar cultivars without expanding the acreage of area devoted to potato production. There is no reason to anticipate changes to the availability of non

- GE potato cultivars on the market based on the entry of this variety into the market.
Approving the petition for a determi nation of nonregulated status for Simplot InnateTM W8 p otato is not expected to change current potato production practices. Studies conducted by Simplot demonstrate th e agronomic characteristics and cultivation practices of Simplot InnateTM W8 p otato are indistinguishable from practices used to grow other potato cultivars ( Simplot, 2014 ; USDA

- APHIS, 2014b )

. Consequently, progeny bearing these genes also appear unlikely to require different practices.

O rganic growers use common practices to maintain the organic status in their potato production, including employing adequate isolation distances between the organic potato field and the fields of neighbors to minimize the chance that pollen will be carried among fields. Given the importance of maintaining varietal traits and consumer recognition and preference for specific potato cultivars, the separation of production and processing of potatoes by cultivars is routinely utilized by growers, packers

an d retailers in the U

. S

. market to satisfy consumer preference and demand. Availability of another p otato cultivar, such as Simplot InnateTM W8 p otato under the Preferred Alternative, is not expected to impact the organic production of potatoes any differently than other potato cultivars currently being grown. Progeny bearing these genes may become delib erately added to specific potato cultivars based on market demand, and the choice to produce those modified varieties remains with each individual farmer.

Based on the info rmation described in Section 4. 7 .1 , Domestic Trade Environment, APHIS concludes that a determination of nonregulated status of Simplot InnateTM W8 p otato will have no foreseeable adverse cumulative effects on domestic commerce. Simplot InnateTM W8 potato has the potential to improve potato processing capabilities and also improves the economics of potato processing and consumer nutrition. There may also be a reduction in cost of processing associated with a reduction in potato browning and in providing alternatives to conventional technologies to prevent browning. Progeny bearing these genes are anticipated to have the same potential for benefits. Based on these factors, no net negative cumulative impacts on domestic economics are identified associated with the production of Simplot InnateTM W8 p otato

. Approving the petition for a determination of nonregulated status to Simplot InnateTM W8 p otato would have the same impacts to water, soil, air quality, and climate change as that of potato cultivars currently available. Agronomic practices that have the potential to impact soil, wat er and air quality, and climate change would not change because Simplot InnateTM W8 p otato is agronomically similar to other potato75

cultivars. Because of its similarity to other potato cultivars, adoption of Simplot InnateTM W8 p otato is expected to replace other similar cultivars without impact ing water, soil, air quality, and climate change differently from other potato varieties

. Cumulative impacts due to climate change are anticipated to be the same for the Simplot InnateTM W8 event and conventional pota toes becau se the ir agronomic characteristics remain similar. Additionally, potato production in the U

. S

. occurs on less than 1 % of the acreage as compared to the acreage occupied by corn and soybeans ( USDA

- NASS, 2012b ) so the magnitude of any climate change due to potato production changes appears unlikely to be detectable

. Cumulative i mpacts of the Pre ferred Alternative to microorganisms and biodiversity are not expected to be significantly different tha n under the No A ction Alternative because Simplot InnateTM W8 p otato is agronomically and compositionally similar to other potato cultivars

. Cumulative impacts to plant communities resulting from gene flow or weediness potential would be the same for the Simplot InnateTM W8 p otato event and conventional potatoes based on m ultiple years of field data , compositional analysis , and a lack of changes in agronomic inputs ( including pesticides and herbicides )

. Gene flow from potatoes , whether biotech or conventional , is unlikely due to the cropping practices of rotation and the clonal propaga tion of potato varieties in U

. S

. agriculture. Consequently, this variety does not present a safety risk, or pose an increased weediness risk in relation to other currently available potatoes based on the information summarized in the PPRA ( USDA

- APHIS, 2014b )

. Cumulative impacts to animal communities would be the same for the Simplot InnateTM W8 p otato event and conventional potatoes. Three years of field data as well as compositional analysis and molecular stability show that the Simplot InnateTM W8 p otato event is equivalent to conventional potatoes ( Simplot, 2014 )

. Even in cases where asparagine was lower (for reducing acrylamide), t he levels were still within the combined literature ranges. In addition, no changes were observed in land use or agronomic inputs including pesticides. Animals consuming Simplot InnateTM W8 p otato may be exposed to increased levels of glutamine, but resea rch on dietary supplementation with glutamine has not had any negative animal health effects. In the future, multiple potato varieties carrying these genes may lead to an increased risk of exposure to increased levels of glutamine, but consumers are more likely to substitute varieties rather than increasing their potato consumption. In general, c umulative effects on human consumer health are expected to be the same for the Simplot InnateTM W8 p otato event and conventional potatoes . There are two major exce ption s : the Simplot InnateTM W8 p otato contains significantly less acrylamide

- forming potential than conventional potatoes , and less reducing sugars than conventional potatoes

. Reduced levels of acrylamide in cooked potatoes are associated with human healt h benefits in consumers. Reduced potential to form acrylamide should result in significant human health benefits, particularly for those with a diet high in potato products produced by cooking at high temperatures

. Compared with the conventional varieties, Simplot InnateTM W8 p otato contained on average 78

- 84 % less acrylamide ( Simplot, 2014 ) . Adoptio n of these potatoes could result in a significant reduction in dietary intake of acrylamide and decrease exposure to this naturally occurring substance found to cause cancer in laboratory animals ( NTP, 2011 )

. In addition, total protein and glycoalkaloid le vels in Simplot InnateTM W8 p otato were unchanged compared with the control varieties ( Simplot, 2014 )

. Although patatin was not measured d uring the studies ( Simplot, 2014 ) , any potential exposure to patatin is not expected to be different under the Preferred Alternative than under the No Action Alternative. Some allergies have been detected in76

children as a result of patatin; however, these allergies are only in children and are uncommon ( De Swert et al. , 2002 ; 2007 ) . Children who are allergic to potatoes would avoid potatoes under the No Action Alternative; therefore, any changes in patatin levels in Simplot InnateTM W8 potato would not impact these children , as they are already avoiding potatoes due to the high proportion of patatin already occurring in conventional potato varieties ( Mignery et al. , 1988 )

. Cumulative impacts to worker safety would be expected to be the same for the Simplot InnateTM W8 p otato event and conventional potatoes because the agronomic practices are not expected to cha nge

. Livestock consuming raw potatoes are not expected to realize any health benefits from reduced acrylamide

- forming potential in these potatoes. Simplot submitted a safety and nutritional assessment of food and feed derived from Simplot InnateTM W8 p otato to the FDA on date April 14, 2014 ( BNF No. 000146 )

. The FDA is presently evaluating the submission. There are n o change s in food and feed safety expected to occur under the Preferred Alternative.
Cumulative impacts on the domestic economic environm ent generally would be similar for the Simplot InnateTM W8 p otato event and conventional potatoes, although some economic impact is expected because of the potential health benefits associated with the se new potatoes. This event grow s similarly and has similar biochemical composition to conventional potatoes, however, the low acrylamide, reducing sugars, black spot bruise , and late blight resistant traits add value that could increase the price received for these potatoes. Potatoes with these traits ar e expected to have higher market value for the same inputs, representing potential increased revenue for growers and processors, and an overall increase in the value of potato production. To the extent that these traits become incorporated into many other existing varieties, this added market value is anticipated to diminish.
Cumulative impacts to the trade economic environment generally would be similar for the Simplot InnateTM W8 event and conventional potatoe s, unless the potential health benefits becom e an important factor in international marketing. Increased demand is expected to lead to increased supply of these potatoes, but to the extent that other countries indiscriminately block importation of GE foods, these opportunities may be missed.

Introd uction of Simplot InnateTM W8 p otato will require channeling of the new potatoes into the desired markets. The careful supply chain introduction would be similar to all potato variety management systems already in place for product purity. It is expected that development and implementation of identity preservation systems will add some cost to the supply chain; the total costs will depend upon the type and extent of market penetration ( Simplot, 2014 ) . The Simplot InnateTM W8 p otato could have cumulative economic impacts on the domestic potato market and procedures developed to manage product purity in the supply chain.
Upon introduc tion, procedures will be implemented to prevent unintended mixing of Simplot InnateTM W8 potato with conventional potatoes as part of the stewardship program. In addition, Simplot is seeking international regulatory approvals in areas such as Japan and Mex ico for import approval. Also, approval in Canada is being sought for import and cultivation. Approval in these key trading countries will minimize market disruption should a low

- level presence of Simplot InnateTM W8 potatoes be found in the market from a ccidental mixing. T he Simplot InnateTM W8 potatoes could have cumulative trade77

economic impacts on the potato export market and procedures developed to manage product purity in the supply chain.
Simplot InnateTM W8 p otato , and the deployment of the genes in this variety, may offer protection against black spot bruise, lower reducing sugars, late blight resistance and reduced acrylamide potential. During processing, potatoes are routinely culled due to black spot bruise when making French fries or potato chi ps. H owever, with Simplot I nnateTM W8 p otato, fewer potatoes will be lost to black spot bruise, resulting in less waste. Similarly, the late blight resistance gene should markedly improve survival of potato crops threatened with late blight, and consequen tly, increase yield. As a result of increased usable yield per pound existing production becomes more efficient, so less acreage can meet the demand for potatoes. Reductions in potato acreage are associated with fewer agricultural inputs and concomitant environmenta l benefits with associated positive environmental impacts related to land use and agricultural inputs. For the purposes of th is cumulative impacts discussion, however, it is conservatively assumed that land use and agronomic inputs would poten tially decline or remain the same, and are unlikely to increase

. 6 THREATENED AND ENDAN GERED SPECIES
The Endangered Species Act (ESA) of 1973, as amended, is one of the most far

- reaching wildlife conservation laws ever enacted by any nation. Congress passed the ESA to prevent extinctions facing many species of fish, wildlife and plants. The purpose of the ESA is to conserve endangered and threatened species and the ecosystems on which they depend as key components of America’s heritag e. To implement the ESA, the U

. S

. Fish & Wildlife Service (USFWS) works in cooperation with the National Marine Fisheries Service (NMFS), other Federal, State, and local agencies, Tribes, non

- governmental organizations, and private citizens. Before a plant or animal spec ies can receive the protection provided by the ESA, it must first be added to the Federal list of threatened and endangered wildlife and plants.
A species is added to the list when it is determined by the USFWS/NMFS to be endangered or threatened because o f any of the following factors:

 The present or threatened destruction, modification, or curtailment of its habitat or range;

 Overutilization for commercial, recreational, scientific, or educational purposes;

 Disease or predation;

 The inadequacy of existing regulatory mechanisms; and

 The natural or manmade factors affecting its survival.
Once an animal or plant is added to the list , protective measures apply to the species and its habitat. These measures include protection from adverse effects of f ederal activities.
Section 7 (a)(2) of the ESA requires that federal agencies, in consultation with USFWS and/or the NMFS, ensure that any action they authorize, fund, or carry out is “not likely to jeopardize the continued existence of a listed species or resu lt in the destruction or adverse modification of designated critical habitat.” It is the responsibility of the federal agency taking the action to assess the effects of their78

action and to consult with the USFWS and NMFS if it is determined that the actio n “may affect” listed species or designated critical habitat. To facilitate their ESA consultation requirements, APHIS met with the USFWS from 1999 to 2003 to discuss factors relevant to APHIS’ regulatory authority and effects analysis for petitions for n onregulated status and developed a process for conducting an effects determination consistent with the Plant Protection Act (PPA) of 2000 (Title IV of Public Law 106

- 224). APHIS also uses this process to help fulfill its obligations and responsibilities u nder Section 7 of the ESA for biotechnology regulatory actions.
APHIS met with USFWS officials on June 15, 2011, to discuss whether APHIS has any obligations under the ESA regarding analyzing the effects of herbicide use associated with all GE crops on TES . As a result of these joint discussions, USFWS and APHIS have agreed that it is not necessary for APHIS to perform an ESA effects analysis on pesticide use associated with GE crops because EPA has both regulatory authority over the labeling of pesticides under FIFRA, and the necessary technical expertise to assess pesticide effects on the environment. APHIS has no statutory authority to authorize or regulate the use of pesticides used by potato growers. Under APHIS’ current Part 340 regulations, APHIS o nly has the authority to regulate the Simplot InnateTM W8 potato or any GE organism as long as APHIS believes they may pose a plant pest risk (7 CFR § 340.1) . APHIS has no regulatory jurisdiction over any other risks associated with GE organisms including risks resulting from the use of herbicides or other pesticides on those organisms.
As part of its EA analysis, APHIS is analyzing the potential effects of these potato events on the environment including, as required by the ESA, any potential effects to threatened and endangered species and critical habitat. As part of this process , APHIS thoroughly reviews the GE product information and data related to the organism (generally a plant species, but may also be other genetically engineered organisms). For each transgene/transgenic plant, APHIS considers the following:

 A review of the biology and taxonomy of the crop plant and its sexually compatible relatives;

 Characterization of each transgene with respect to its structure and function and the nature of the organism from which it was obtained;

 A determination of where the new transgene and its products (if any) are produced in the plant and their quantity;

 A review of the agronomic performance of the plant, including disease and pest susceptibilities, wee diness potential, and agronomic and environmental impacts;

 Determination of the concentrations of known plant toxicants (if any are known in the plant);

 Analysis to determine if the transgenic plant is sexually compatible with any threatened or endangered species (TES) of plants or a host of any TES; and

 Any other information that may inform the potential for an organism to pose a plant pest risk. In following this review process, APHIS, as described below, has evaluated the potential effects that a determi nation of nonregulated status of the potato events may have, if any, on federally

- listed TES species and species proposed for listing, as well as designated critical habitat and habitat proposed for designation.79

Based upon the scope of the EA and productio n areas identified in the Affected Environment section of the EA, APHIS reviewed the USFWS list of TES species (listed and proposed) for each state where potato is commercially produced from the USFWS Environmental Conservation Online System (ECOS; as

acce ssed February 19, 2014 at http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrence.jsp ) ( USDA

- APHIS, 2015a ; 2015b ) . Prior to this review, APHIS considered the potential for Simplot InnateTM W8 potato to extend the range of pota to production and also the potential to extend agricultural production into new natural areas. APHIS has determined that agronomic characteristics and cultivation practices required for Simplot InnateTM W8 potato are essentially indistinguishable from prac tices used to grow other potato varieties ( Simplot, 2014 ; USDA

- APHIS, 2014c ; 2014b )

. Sim plot InnateTM W8 potato may be expected to replace other varieties of potato currently cultivated, and APHIS does not expect the cultivation of Simplot InnateTM W8 potato to result in new potato acres to be planted in areas that are not already devoted to agriculture. Accordingly, the issues discussed herein focus on the potential environmental consequences of the determination of nonregulated status of Simplot InnateTM W8 potato on TES species in the areas of the U

. S

. where potatoes are currently grown.
Simplot has used a genetic engineering approach to introduce into the background of commercial potato cultivars four traits that are of interest to potato consumers, produce rs and processors: late blight resistance, reduced acrylamide potential in certain processed or heated potato products, reduced black spot bruise, and lowered reducing sugars ( Simplot, 2014 ) . The Simplot InnateTM W8 potato event was constructed by first transforming Russet Burbank with plasmid, pSIM1278, followed by transformation with a second plasmid, pSIM1678 to produce the stacked traits . The objective was to incorporate the new phenotypes into event W8, while maintaining all of the desirable characteristics originally selected by potato breeders ( Simplot, 2014 )

. As described in the petition and PPRA, the inserted DNA contains silencing cassettes that, when expressed, generate variably

- sized and unprocessed transcripts. These transcripts trigger the degradation of mRNAs t hat would normally code for an enzyme, like asparagine synthetase. This results in much reduced levels of the targeted enzymes ( Simplot, 201 4 )

. For its analysis on TES plants and critical habitat, APHIS focused on the agronomic differences between Simplot InnateTM W8 potato and potato varieties currently grown; the potential for increased weediness; and the potential for gene movement to na tive plants, listed species, and species proposed for listing.
For its analysis of effects on TES animals, APHIS focused on the implications of exposure to Simplot InnateTM W8 potato , and the potential for an effect resulting from the gene silencing activit y that sets Simplot InnateTM W8 potato apart from other potato lines currently in production.

6 .1 Potential Effects of Simplot InnateTM W8 potato on TES and Critical Habitat The agronomic and morphologic characteristics data provided by Simplot were used in the APHIS analysis of the weediness potential for InnateTM Event W8 Potato , and further evaluated for the potential to impact TES and critical habitat. Agronomic studies co nducted by JR Simplot during 2012 and 2013 tested the hypothesis that there would be no change in agronomic practices used to produce Simplot InnateTM W8 potato in comparison with conventional potato ( Simplot, 2014 ) . A gronomic evaluations80

were conducted in geographically distinct sites selected to represent most of the main production areas for potatoes in the USA. Characteristics evaluated included time to emergence, vigor, leaf size, leaf curl, vine maturity, disease susceptibility, insect damage, yield, specific gravity, and abiotic stressors (frost, hail, heat, herbicide, and wind) ( Simplot, 2014 )

. Relative to the Russet Burbank control, there was no consistent trend among the InnateTM Event W8 for significant increases in final emergence, stems per plant, or vine desiccat ion. There were no statistically significant reductions in total yield. The Simplot InnateTM W8 potato was lower than the control for early emergence (39.5 % vs 61.5%), and plant vigor (3.0 vs 3.7); and shorter than the control for plant height (40.4 vs 45 .1 cm). All of these detected differences were within the conventional variety range for potato. Simplot InnateTM W8 potato did not display any notable differences to the control in tolerance to abiotic stresses or biotic stresses ( Simplot, 2014 )

. No differences were detected between Simplot InnateTM W8 potato and conventional potato in growth, reproduction, or interactions with pests and diseases that would indicate a significant change in agronomic practices would be necessary for the commercial production of this transformed line ( Simplot, 2014 )

. Potatoes are not known to be weedy or persistent; they are incapable of survival outside of cultivation ( Holm et al. , 1979 ; Muenscher, 1980 ; Love, 1994 ; OECD, 1997 ) . Potato tubers have a fairly low frost tolerance; shallow tub ers and those exposed to the surface are often destroyed by frost, but in temperate climates up to 20% of tubers left in the soil show no dormancy and will sprout the next

season ( An dersson and de Vicente, 2010 ) . Volunteer potatoes, growing from overwintered tubers, can be a weed problem in the following crop but are easily controlled with cultivation and herbicides and do not persist as weeds for more than a few years ( Andersson and de Vicente, 20 10 )

. The data presented by Simplot demonstrate that the Simplot InnateTM W8 potato is for the most part phenotypically and agronomically similar to the respective parent variety and does not exhibit meaningful changes in characteristics that would make it weedier or more persistent than the parent variety ( Simplot, 2014 ) . Because of the reductions in emergence and yield, the Simplot Inn ateTM W8 potato appears to have a reduced potential for weediness ( USDA

- APHIS, 2014b ) . Furthermore, post

harvest monitoring of field test plots planted with the GE crop event under USDA

- APHIS notificatio ns and permits did not reveal any differences in survivability or persistence relative to other varieties of the same crop currently being grown. Volunteers were rarely observed, were easily controlled, and are not engineered for resistance to herbicides ( Simplot, 2014 ) . No differences were observed that would suggest that the Simplot InnateTM W8 potato is more likely to become a weed than the conventional varieties of the crop ( USDA

- APHIS, 2014c )

. Based on the agronomic field data and literature survey

con cerning weediness potential of the crop, APHIS has determined that the Simplot InnateTM W8 potato is unlikely to persist as a troublesome weed or to have an impact on current weed management practices ( USDA

- APHIS, 2014b )

. APHIS evaluated the potential of Simplot InnateTM W8 potato to cross with native plants and listed species, and the possibility that such crosses could result in hybrids that could affect critical habita t. As discussed thoroughly in Sec tions 2.3.3 and 4.5 .3 Gene Flow and Weediness, APHIS has determined that there is little risk of gene flow to related plant species and no risk to unrelated plant species from the cultivation of Simplot InnateTM W8 potato

. Simplot InnateTM W8 potato derived from Russet Burbank81

produces few flowers and is male sterile ( Simplot, 2014 )

. Among native Solanum spp. in the U

. S

. , cultivated potato is potentially sexually

- compatible only with two tuber

- bearing species, S. jamesii and S. stoloniferum (previously S. fendleri ( Spooner et al. , 2004 ) ) . These two species are found only in Texas, New Mexico, and Arizona, and S. jamesii is further found in Colorado and Utah. In some cases these species are found in counties with commercial potato production ( USDA

- NRCS, 2013 ; Simplot, 2014 ) . As discussed thoroughly in the PPRA, numerous biological and geographic obstacles make gene flow from these cultivated potato varieties to the two wild relatives a highly unlikely occurrence, and there have been no reports that such cro sses have ever occurred naturally ( Love, 1994 ; US

- EPA, 2011b ) b . However, because it is scientifically plausible that c ultivated potatoes could hybridize with S. stoloniferum, the PPRA considered the potential impact on the weediness of S. stoloniferum if gene introgression from Simplot InnateTM W8 potato were to occur. The resulting analysis concluded that the novel pheno types (low acrylamide potential, reduced black spot bruise, late blight resistance, and lowered reducing sugars) did not impart any significant change in the agronomic properties or response to biotic or abiotic stresses that would cause them to be more we edy ( USDA

- APHIS, 2014b )

. A review of the USFWS database of listed species indicates that there are three species of the Solanaceae family in the genus Solanum that are listed as endangered. Aiakeakua pop olo ( S. sandwicense ) and popolo ku mai ( S. incompletum ) both found only in Hawaii, and Erubia ( S. drymophilum ) found only in Puerto Rico. There are also two candidate species: popolo ( S. nelsonii ) found only in Hawaii, and marron bacora ( S. conocarpum ) f ound only in the U

. S

. Virgin Islands ( USFWS, 2014a )

. Crosses between these species and Simplot InnateTM W8 potato would be highly unlikely because these species are not found in areas of potato production and even if they were found toge ther, crosses would be unlikely because the biology of potato as described in S ections 2.4.3 and 4.4.3 Gene Flow and Weediness, and in the PPRA ( USDA

- APHIS, 2014b )

. Based on agronomic field data, litera ture surveyed on potato weediness potential, and the unlikelihood of crosses with wild relatives, APHIS has concluded that Simplot InnateTM W8 potato will have no effect on threatened or endangered plant species or critical habitat.
Threatened and Endangere d Animal Species
For its effects analysis on TES animal species, APHIS focused on the likelihood of species to be exposed to Simplot InnateTM W8 potato and possible effects that could occur as a result of such contact. Exposure of TES species to Simplot InnateTM W8 potato is only likely if the species occur in the areas where potato is grown, because potato plant parts (seeds, tubers, pollen, vegetation, crop debris) are not readily transported long distances without hu man intervention. Threatened and endangered animal species that may be exposed to Simplot InnateTM W8 potato would be those TES that inhabit potato fields and may feed on InnateTM p otato. Few , if any , TES are likely to use potato fields because they do
not provide suitable habitat. In general, the majority of threatened and endangered species are found in more natural habitats ( USFWS, 2011 )

. Little information can be found concerning threatened or endangered species in farm fields, especially potato fields. In an Environmental Assess ment on the use of genetically engineered corn and soybean in refuges in the mid

- west, the USFWS reported that whooping crane ( Grus americana ), sandhill crane ( Grus canadensis pulla ), piping plover ( Charadrius melodus ), interior least tern ( Sterna antillar um ), and82

Sprague’s pipit ( Anthus spragueii; a candidate species) occasionally feed in farmed sites ( USFWS, 2011 )

. Although possible that these bird species may visit potato fields during migratory periods, it is unlikely they would be present during normal farming operations ( USFWS, 2011 ) . USDA

- APHIS Wildlife Services has received complaints for damage to corn, wheat, and potatoes caused by sandhill cranes ( USDA

APHIS, 2013b )

. As discussed in Section 2.3 .1 Animal Communities, there are few animals reported to consume potato plants in an agricultural setting. This is not surprising considering the foliage and stems of potato contain toxic glycoalkaloids known to cause illness when consumed ( Sinden, 1987 ) . Known exceptions are whitetail deer, wild boar, and voles ( O'Brien, 2005 ; Marinette County, 2014 ; Taylor, 2014 ) . There are two listed sub

- species of white

- tailed deer and three listed vole species within States that have commercial potato production. The Columbia white

- tailed deer ( Odocoileus virginianus leucurus ) has two populations; one population in Douglass County, Oregon was delisted in 2003. The other, listed as endangered, is located in the lower Columbia River Valley in Washington State ( USFWS, 1983 )

. Neither population is found in areas of significant potato production as indicated in Figure 1: Po tato Growing Regions of the U

. S

. ( USDA

- NASS, 2007 ) . The endangered Key deer ( Odocoileus virginianus clavium ) is found only on the extreme tip of southern Flori da far from any commercial potato production ( USFWS, 2014c ) . The three vole species are listed as endangered. The Amargosa vole ( Micro t us californicus scirpensis ) is found in Inyo County in southeast California which is not an area of potato production ( USFWS, 2014b ) . The Florida salt marsh vole ( Microtus pennsylvanicus dukecampbelli ) is found in saltmarshes of Levy County in coastal Florida, also not in areas of potato production ( USFWS, 2014d )

. The Hualapai Mexican Vole ( Microtus mexicanus hualapaiensis ) is found in Mohave County, Arizon a, where potatoes are a minor crop. However, the species would be unlikely to be found in potato fields because it is found only in woodlands and grasslands in the canyons of the Hualapai Mountains ( USFWS, 1991 )

. Although unlikely, APHIS considered the possible effects on TES if they were to consume Simplot InnateTM W8 potato. Detailed compositional is found in Section 8 of the petition. Simplot analyzed tubers of the Event W8 and its respective parent for the following constituents: protein, fat, ash, crude fiber, carbohydrates, calories, moisture, vitamin B 3 , vitamin B 6 , vitamin C, Cu, Mg, K, amino acids, and glycoalkaloids. The compositional assessments determined the amounts of 1) moisture, protein, total fat, ash, crude fiber, carbohydrate and calories; 2) vitamins B6, B3 and C; 3) minerals copper, magn esium and potassium; 4) glycoalkaloids; 5) amino acids for tubers collected from events grown in 2012 and 2013 in potato

- gr owing areas of the U

. S

. ( Simplot, 2014 ) . Based on the compositional analyses presented in the petition, APHIS concludes that although raw tubers had some statistically significant differences in nutritional components (vitamins C and B6; certain amino acids) compare d to the parental variety (Russet Burbank), they are within the normal range for commercial potato varieties. For the few cases when significant differences were detected between Simplot InnateTM W8 potato and its parental variety, the mean values for the W8 event all fell within the tolerance interval and within the combined literature range for potatoes ( Simplot, 2014 ; USDA

- APHIS, 2014b )

.
As discus sed in Section 4 .6.1 , Human Health, issues with allergies to Simplot InnateTM W8 potato would be unlikely beyond what individuals with potato allergies would normally experience. The modifications did not alter the quality of potato as food other than lower levels of acrylamid e after cooking, lower black spot bruise, late blight resistance, and lowered reducing sugars. Simplot submitted a safety and nutritional assessment of food and feed derived from Simplot InnateTM W8 potato to the FDA on BNF No. 000146 . FDA is presently ev aluating the submission.83

As discussed in Section 4 .5 .1 , Animal Communities, there are a large number of insects that feed on potato leaves and other insects that feed on those pests. No differences were observed for insects or other animals interacting within the potato ecosystem during the field trials, leading to the conclusion that the InnateTM potatoes would have the same impact on other organisms as conventional potatoes ( Simplot, 2014 )

. There is no evidence that animal exposure to Simplot InnateTM W8 potato would have any effect or be any less attractive as food, refuge, cover and nesting sites as non GE varieties of potatoes.
APHIS considered the possibility that Simplot InnateTM W8 potato could serve as a host plant for a threatened or endangered species. A review of the species list reveals that there are no members of the genus Solanum that serve as a host plant for any thre atened or endangered species ( USDA

- APHIS, 2014b )

. Considering the lack of expected exposure and the expectation that such exposure would produce no response different than potato varieties currently in production, cultivation of Simplot InnateTM W8 potato an d their progeny are expected to have no effect on threatened or endangered animals.

Summary

After reviewing the possible effects of allowing the environmental release of InnateTM Event W8 Potato , APHIS has not identified any stressor that could affect the reproduction, numbers, or distribution of a liste d TES or species proposed for listing. APHIS also considered the potential effect of a determination of nonregulated status of Simplot InnateTM W8 potato on designated critical habitat and habitat proposed for designation, and could identify no differences from effects that would occur from the production of other potato varieties. Potato is not considered a particularly competitive plant species and has been selected for domestication and cultivation under conditions not normally found in natural settings ( Holm et al. , 1979 ; Muenscher, 1980 ; Love, 1994 ; OECD, 1997 ) . There is no ability of Simplot InnateTM W8 potato to naturally hybridize with any wild Solanum species, including listed spec ies. Simplot InnateTM W8 potato will not serve as a host species for any listed species or species proposed for listing. Consumption of Simplot InnateTM W8 potato by any listed species or species proposed for listing will not result in a toxic or allergic reaction. Based on these factors, APHIS has concluded that a determination of nonregulated status of Simplot InnateTM W8 potato , and the corresponding environmental release of these potato events will have no effect on listed species or species proposed fo r listing, and would not affect designated habitat or habitat proposed for designation. Because of this

no

- effect determination, consultation under Section 7(a)(2) of the Act or the concurrences of the USFWS or NMFS is not required.

7 CONSIDERATION OF EXE CU TIVE ORDERS, STANDAR DS, AND TREATIES REL ATING TO ENVIRONMENTAL IMPACT S

7.1 Executive Orders with Domestic Implication s
The following executive orders require consideration of the potential impacts of the Federal action to various segments of the population.84

 Executive Order (EO) 12898 ( US

- NARA, 2010 ) , "Federal Actions to Address Environmental Justice in Minority Populations and Low

- Income Populations," requires Federal agencies to conduct their programs, policies, and activities that substantially affect human health or the environment in a manner so as not to exclude persons and populations from participation in or benefiting from such programs. It al so enforces existing statutes to prevent minority and low

- income communities from being subjected to disproportionately high and adverse human health or environmental effects.

 EO 13045, “Protection of Children from Environmental Health Risks and Safety Ri sks,” acknowledges that children may suffer disproportionately from environmental health and safety risks because of their developmental stage, greater metabolic activity levels, and behavior patterns, as compared to adults. The EO (to the extent permitte d by law and consistent with the agency’s mission) requires each Federal agency to identify, assess, and address environmental health risks and safety risks that may disproportionately affect children.

Neither t he No Action nor the Preferred Alternative is expected to have a disproportionate adverse effect on minorities, low

- income populations, or children because the Simplot InnateTM W8 p otato event is agronomically, phenotypically, and biochemically similar to conventional potatoes except for the low acryl amide potential and reduced black spot bruise trait s

. To establish that the new cultivars are nutritionally equivalent to their parent cultivars, Simplot InnateTM W8 potato and the control Ranger Russet potato were subjected to nutritional and proximate analysis, and measured for free amino acids, total amino acids, glycoalkaloids, sugars, and acrylamide levels. This means they are not likely to have adverse effects o n individuals within those populations when they are consumed

. At present, studies suggest that potatoes represent over 30% of vegetable consumption in U

. S

. children in and out of school ( Olsho and Fernandes, 2013 ) and that urban /minority youths are more likely to consume more fried potato products than youths living in a non

- urban

en vironment ( Davis and Carpenter, 2009 )

. Olsho and Fernandes ( 2013 ) suggest that the targeting of potato preparation methods may represent a more viable method to improve the healthfulness of potato dishes, and as such, the introduction and use of Simplot Innate TM W8 potato may improve any disparate adverse effect associated with potato consumption in the U

. S.

Reduced free asparagine (ASN) and total ASP + ASN, increased free GLN and total GLU + GLN, reduced acrylamide, and lowered reducing sugar s were observed and expected as a result of gene silencing. This reduction c ould benefit consumers by addressing a food safety issue in potato industry ( NTP, 2011 ) . Other unexpected significant differences were reported, but the values are all within the normal ranges for potatoes . J3 tubers contained an average of 0.117 mg/100 g pyridoxine (vitamin B6) as compared to the controls, which had 0.124 mg/100g. J55 also had decreased pyridoxine. J3 tubers had an average of 134 ppm of free VAL as compared to the controls, which had 147 ppm. J55 also experienced decreased VAL; H37 had decreased LYS; F37 had increased free ARG; G11 had increased total LYS and PRO; F10 and F37 had increased vitamin C and niacin; E12 and E24 had decreased sucrose; and H37 had in creased sucrose. These deviations in various amino acids and vitamins, while experimentally significant, do not exceed the range of variation observed in conventional potato varieties ( USDA

- APHIS, 2014b )

.85

Potatoes also were tested for reducing sugars and acrylamide after storage. The event had lowered levels of reducing sugars at the time of harvest or one month of storage, but significant differences were not routinely observed after 2

- 5 months com pared to conventional potato varieties

. Storage up to 7 months yielded consistently lower acrylamide levels in the event than in the controls, although there were exceptions with the G and H varieties. Overall, the modifications from insertion of pSIM127 8 resulted in reductions in acrylamide that persisted throughout the storage period.

Research confirmed that the overall levels of natural glycoalkaloids, a tox in commonly found in solanaceous crops including potato, were not increased in the Simplot Inn ate TM W8 event . The safety limit is 20mg/100g as described by Sinden ( 1987 )

. As presented in the APHIS PPRA ( USDA

APHIS, 2014b ) , while some Simplot Innate TM W8 potato events exhibited higher glycoalkaloid
content , its respective contr ols also exhibited higher glycoalkaloid levels and that these observed concentrations of glycoalkaloids still remain in the range of typical potato glycoalkaloid levels described in the literature. This finding suggests that there are no safety concerns w ith Simplot Innate TM W8 potato due to similarities in composition

.

Patatin is a potato storage glycoprotein that m akes up approximately 40 % of the soluble protein in tubers. Although patatin was not measured during the studies ( Simplot, 2013 ) , any potential exposure to patatin is not expected to be different as a result of a determination of nonregulated status for Simplot Innate TM W8 potato. Some allergies have been detected in children as a result of patatin; however, these allergies are only in children and are uncommon ( De Swert et al. , 2002 ; 2007 ) . Children who are allergic to potatoes would avoid potatoes under the No Action Alternative; therefore, any changes in patatin levels in Simplot InnateTM W8 potato would not impact these childre n, as they are already avoiding potatoes due to the high proportion of patatin already occurring in conventional potato varieties ( Mignery et al. , 1988 )

.
In summary, the compositional data presented in the Simplot petition ( Simplot, 2014 ) and analyzed in the APHIS PPRA ( USDA

- APHIS, 2014b ) indicates that Simplot Innate TM W8 potato does not substantially differ from conventional potato varieties with the exception of the introduced traits. As a result, Simplot Innate TM W8 potato is not expected to have a disproportion ate adverse effect on minorities, low

- income populations, or children

.
Simplot initiated the consultation process with FDA for the commercial distribution of Simplot InnateTM W8 p otato and submitted a safety and nutritional assessment of food and feed deri ved from Simplot InnateTM W8 p otato to the FDA ( Simplot, 2014 ) . FDA is presently evaluating the submission. The following executive orde r addresses Federal responsibilities regarding the introduction and effects of invasive species:

EO 1311 ( US

- NARA, 2010 ) , “Invasive Species,” states that Fede ral agencies take action to prevent the introduction of invasive species, to provide for their control, and to86

minimize the economic, ecological, and human health impacts that invasive species

cause.
Based on historical experience with potatoes and data submitted by the applicant and revi ewed by APHIS, Simplot InnateTM W8 p otato is not expected to become weedy or invasive. Potatoes are not li sted in the U

. S

. as a noxious weed species by the Federal government (7 CFR Part 360 ) ( USDA

- NRCS, 2014 ) , nor is it listed as an invasive species by major invasive plant databases. Standard potato

- growing practices make it highly unlikely that potatoes would persist in a field from one crop cycle to the next. In areas where potatoes are grown as a rotation crop, any potatoes left in the field generally are eliminated by tilling, field preparations with herbicides, and harsh winters. To maximize an economic return, p otato growers rarely leave the ground fallow

. A ny potatoes inadvertently growing in a fallow field are not protected with insecticide s or fungicide s; they would be susceptible to the Co lorado potato beetle and early blight , and likely die

. Potatoes are not known to escape from fields (become feral) or show weediness potential. Potato seedlings grown from tubers have difficulty establishing because they are poor competitors against grass es, trees, and shrubs. T he traits incorporated into Simplot InnateTM W8 p otato are not associated with weediness and these traits will not help plants thrive outside of cultivation. The following Executive Order sets forth guidelines for consulting with In dian tribal governments:

EO 13175 , “Consultation and Coordination with Indian Tribal Governments” states that each Indian tribe has the opportunity to participate in policy development to the greatest extent practicable and permitted by law. Each tribe ha s the opportunity for timely and meaningful government

- to

- government consultation with APHIS in developing policies that may have tribal implications. Such policies that could have substantial direct effects on one or more Indian tribes, on the relationsh ip between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes. “Substantial direct effects” means positive, neutral, or negative effects and potential effects tha t APHIS or the tribes see as significant. APHIS’ proposed action, a determination of nonregulated status of Simplot InnateTM W8 potato is not expected to adversely impact cultural resources on tribal properties. Any farming activity that may be taken by farmers on tribal lands would only be conducted at the tribe’s request; thus, the tribes would have control over any potential conflict with cultural resources on tribal properties. APHIS sent letters to Tribal entities when this petition was declared com plete and made available to the public. There were no comments received from any tribal entities

. APHIS considered the impact to tribes or tribal properties in the EA (Section 7.5 National Historic Preservation Act [NHPA] of 1966 as Amended)

. As a result of that analysis, it was concluded that a determin ation of nonregulated status of Simplot Innate TM W8 potato will not adversely impact cultural resources on tribal properties. A determination of nonregulated status of Simplot Innate TM W8 potato GD743 wil l not adversely impact cultural resources on tribal properties. Any farming activities that may be taken by farmers on tribal lands are only87

conducted at the tribe’s request; thus, the tribes have control over any potential conflict with cultural resource s on tribal properties. A determination of nonregulated status of Simplot Innate TM W8 potato would have no impact on districts, sites, highways, structures, or objects listed in or eligible for listing in the National Register of Historic Places, nor woul d they likely cause any loss or destruction of significant scientific, cultural, or historic resources. This action is limited to a determination of nonregulated status of Simplot Innate TM W8 potato

. Standard agricultural practices for land preparation, planting, irrigation, and harvesting would be used on these agricultural lands including the use of EPA registered pesticides. Applicant’s adherence to EPA label use restrictions for all pesticides will mitigate impacts to the human environment. A determ ination of nonregulated status of Simplot Innate TM W8 potato is not an undertaking that may directly or indirectly cause alteration in the character or use of historic properties protected under the National Historic Preservation Act. In general, common a gricultural activities conducted under this action do not have the potential to introduce visual, atmospheric, or audible elements to areas in which they are used that could result in effects on the character or use of historic properties. For example, the re is potential for audible effects on the use and enjoyment of a historic property when common agricultural practices, such as the operation of tractors and other mechanical equipment, are conducted close to such sites. A built

- in mitigating factor for t his issue is that virtually all of the methods involved would only have temporary effects on the audible nature of a site and can be ended at any time to restore the audible qualities of such sites to their original condition with no further adverse effect s. Additionally, these cultivation practices are already being conducted throughout the apple production regions. The cultivation of Simplot Innate TM W8 potato does not inherently change any of these agronomic practices so as to give rise to an impact unde r the NHPA.
The following executive order requires the protection of migratory bird populations:

EO 13186 ( US

- NARA, 2010 ) , “Responsibilities of Federal Agencies to Protect Migratory Birds,” states that federal agencies taking actions that have, or are likely to have, a measurable negative effect on migratory bird populations are directed to develop and implement, within two years, a Memorandum of Understa nding (MOU) with the Fish and Wildlife Service that shall promote the conservation of migratory bird populations.
APHIS has in place a signed MOU with the FWS ( USDA

- APHIS and USFWS, 2012 ) . In accordance with this MOU, APHIS has considered the potential impacts of InnateTM W8 potato on migratory birds.
Based on historical experience with potatoes and data submitted by the applicant and revi ewed by APHIS, Simplot InnateTM W8 p otato is expected to have the same interactions with migratory birds as conventional potatoes. The applicant provided data to demonstrate the compositional equivalency of InnateTM W8 p otato and other potato varie ties 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 W8 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. Migratory birds are not attracted to potato fields for potatoes; however, waterfowl forage extensively in88

agricultural fields in the fall and winter and are at risk for exposure to pesticides. In addition, raptors are at risk of exposure to pesticides if they consume dead or dying waterfowl from the fields. With regard to pesticide use, the Simplot InnateTM W8 p otato event is si milar to their conventional cultivated potato counterparts , and therefore would not require additional use of pesticide applications. No “take” of a migratory bird is expected as a result of growing InnateTM W8 p otato, and APHIS could not determine any mech anism by which take would occur, or would occur any differently than production of any other potato variety.

7.2 International Implications

 EO 12114 ( US

- NARA, 20 10 ) , “Environmental Effects Abroad of Major Federal Actions” requires agencies to consider the potential enviro nmental effects outside the U

. S

. , its territories, and possessions for proposed federal actions

. APHIS does not expect a significant environmental impact outside the US in the event of a determination of nonregulated status of Simplot InnateTM W8 p otato because existing national and international regulatory authorities and phytosanitary regimes will ap ply.
Any international trade of Simplot InnateTM W8 p otato subsequent to a determination of nonregulated status of the product would be fully subject to national phytosanitary requirements and be in accordance with phytosanitary standards developed under the International Plant Protection Convention ( IPPC, 2010 ) . In April 2004, a standard for PRA of living modified organisms (LMOs) was adopted at a meeting of the governing bod y of the IPPC as a supplement to an existing standard, International Standard for Phytosanitary Measure No. 11 (ISPM

- 11, Pest Risk Analysis for Quarantine Pests). Th is standard acknowledges that all LMOs will not present a pest risk and that a determinati on needs to be made early in the PRA for importation as to whether the LMO poses a potential pest risk resulting from the genetic modification. APHIS pest risk assessment procedures for genetically engineered organisms are consistent with the guidance dev eloped under the IPPC.

I ssues that may relate to commercialization and transboundary movement of particular agricultural commodities produced through biotechnology are addressed through treaties, in international forums , and through national regulations. These sources include the North American Plant Protection Organization (NAPPO), the Organization for Economic Cooperation and Development (OECD), and the North American Biotechnology Initiative (NABI), among others

. For example, t he Cartagena Protocol o n Biosafety is a treaty under the United Nations Convention on Biological Diversity (CBD) that established a framework for the safe transboundary movement, with respect to the environment and biodiversity, of LMOs, which include those modified through biot echnology. E xporters need to comply with the regulations that importing countries wh o are Parties to the Protocol have promulgated. The first intentional transboundary movement of LMOs intended for environmental release (field trials or commercial planti ng) will require consent from the importing country under an advanced informed agreement (AIA) provision, which includes a requirement for a risk assessment consistent with Annex III of the Protocol and the required documentation.89

LMOs imported for food, f eed, or processing (FFP) are exempt from the AIA procedure, and are covered under Article 11 and Annex II of the Protocol. Under Article 11, Parties must post decisions to the Biosafety Clearinghouse database on domestic use of LMOs for FFP that may be su bject to transboundary movement. To facilitate compliance with obligations to this protocol, the Federal g overnment developed a website that provides the status of all regulatory reviews completed for different uses of bioengineered products ( NBII, 2010 ) . The applicable data used in analyses of the Simplot InnateTM W8 p otato event will be availabl e to the Biosafety Clearinghouse.
7.3 Compliance with Clean Water Act and Clean Air Act
This EA evaluated the potential changes in potato production associated with a determination of nonregul ated status of Simplot InnateTM W8 p otato (Section 4.3, Agricultural Production of Potato ) and determined that the cultivation of Simplot InnateTM W8 p otato would not lead to the increased product ion or acreage of potato in U

. S

. agricul ture. The S implot InnateTM W8 p otato event do es not possess traits that would allow them to be grown in areas other than those where their conventional counterparts are grown. The low acrylamide potential and reduced black spot bruise trait conferred by the genetic m odification to Simplot InnateTM Simplot Innate TM W8 p otatoes would not result in any changes in water usage for cultivation. As discussed in Section 4.3, Agricultural Production of Potato, there are no expected negative impacts to water resources or air quality a ssociated with Simplot InnateTM W8 p otato production. Base d on these analyses, APHIS concludes that a determination of nonregul ated status of Simplot InnateTM W8 p otatoes would comply with the Clean Water Act and the Clean Air Act.

7.4 Impacts on Unique Characteristics of Geographic Areas

A determination of non

- re gulated status of Simplot InnateTM W8 potato is not expected to impact unique characteristics of geographic areas such as park lands, prime farm lands, wetlands, wild and scenic areas, or ecologically critical areas.
The common agricultural practices that would be carried out in the cultivation of Simplot InnateTM W8 potato are not expected to deviate from current practices. The product will be deployed on agricultural land currently suitable for production of potato , will replace existing varieties, and i s not expected to increase the acreage of potato production. The NHPA of 1966 and its implementing regulations (36 CFR 800) require Federal agencies to: 1) determine whether activities they propose constitute "undertakings" that have the potential to ca use effects on historic properties and 2) if so, to evaluate the effects of such undertakings on such historic resources and consult with the Advisory Council on Historic Preservation (i.e., State Historic Preservation Office, Tribal Historic Preservation Officers), as appropriate.
APHIS’ Preferred Alternative would have no impact on districts, sites, highways, structures, or objects listed in or eligible for listing in the National Register of Historic Places, nor would it likely cause any loss or destru ction of significant scientific, cultu ral, or historical resources. This action is limited to a determination of non

- regulated status of Simplot Innate TM W8 p otato

.90

APHIS’ proposed action is not an undertaking that may directly or indirectly cause alteration in the character or use of historic properties protected under the NHPA. In general, common agricultural activities conducted under this action do not have the p otential to introduce visual, atmospheric, or noise elements to areas in which they are used that could result in effects on the character or use of historic properties. For example, there is potential for increased noise on the use and enjoyment of a his toric property during the operation of tractors and other mechanical equipment close to such sites. A built

- in mitigating factor for this issue is that virtually all of the methods involved would only have temporary effects on the audible nature of a site and can be ended at any time to restore the audible qualities of such sites to their original condition with no further adverse effects. Additionally, these cultivation practices are already being conducted throughout the potato production regions. The cultivation of Simplot Innate TM W8 p otato is not expected to change any of these agronomic practices that would result in an adverse impact under the NHPA.91

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