i 

# J.R. Simplot Company **Petition ( 13**  **- 022**  **- 01p**  **) for Determination of Non**  **- R**  **egulated Status for InnateTM**  **Potatoes with Low Acrylamide Potential**  **and Reduced Black Spot Bruise: Events E12 and E24 (Russet**  **Burbank); F10 and F37 (Ranger Russet); J3, J55, and J78 (Atlantic); G11**  **(G); H37 and H50 (H) OECD Unique Identifiers:**  **SPS -**  **00F10 -**  **7 ;**  **SPS -**  **00F37 -**  **7 ;**  **SPS -**  **0E12 -**  **8 ;**  **SPS -**  **00E24 -**  **2 ;**  **SPS -**  **000J3 -**  **4 ;**  **SPS -**  **00J55 -**  **2 ;**  **SPS -**  **00J78 -**  **7 ;**  **SPS -**  **00G11 -**  **9 ;**  **SPS -**  **00H37 -**  **9 ;**  **SPS -**  **00H50 -**  **4** 

## Draft Environmental Assessment **March 2014**  **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, sex, religion, age, disability, political beliefs, sexual orientation, or marital or family sta tus. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact USDA’S TARGET Center at (202) 720

–2600 (voice and TDD). To f ile 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 employer. 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. Prod

uct 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 agencies b efore they can be recommended.

### TABLE OF CONTENTS **PAGE**

i **TABLE OF CONTENTS** 1 PURPOSE AND NEED
................................ ................................ .............................. 1 1.1 Background
................................ ................................ ................................ .......... 1 1.1 The APHI S Regulatory Authority
................................ ................................ ........ 1 1.1.1 Purpose of this Product
................................ ................................ ................. 2 1.2 Coordinated Regulatory Framework for Genetically
- Engineered Organisms
..... 3 1.2.1 USDA
- APHIS
................................ ................................ ................................ .... 3 1.2.1 Environmental Protection Agency
................................ ................................ 3 1.2.2 Food and Drug Administration
................................ ................................ ..... 4 1.3 Purpose and Need for This APHI S Action
................................ ........................... 5 1.3.1 Public Involvement
................................ ................................ ............................ 5 1.3.2 Public Involvement Approach for This EA
................................ ....................... 7 1.4 I ssues Considered
................................ ................................ ................................ ..... 7 2 AFFECTED ENVIRONMENT
................................ ................................ .................. 9 2.1 Agricultural Production and Agronomic P ractices of Potato
............................... 9 2.2.1 L and Use
................................ ................................ ................................ ............ 9 2.2.2 General Agronomic Practic es ................................ ................................ .......... 12 2.3 Phy sical Environment
................................ ................................ ............................. 20 2.3.1 Water Resources
................................ ................................ .............................. 20 2.3.2 Soil Quality
................................ ................................ ................................ ...... 22 2.3.3 Air Quality
................................ ................................ ................................ ....... 23 2.3.4 Climate Change
................................ ................................ ................................ 24 2.4 Biological Resources
................................ ................................ .............................. 25 2.4.1 Animal Communities
................................ ................................ ....................... 25 2.4.2 Plant Communities
................................ ................................ ........................... 26 2.4.3 Gene Flow and Weediness
................................ ................................ ............... 26 2.4.4 Microorganisms
................................ ................................ ............................... 28 2.1.1 2.2.5 Biodiversity
................................ ................................ ........................ 30 2.2 30 2.2.1 2.2.6 Human Health
................................ ................................ .................... 30 2.2.7 Animal Feed
................................ ................................ ................................ ..... 34 2.3 Socioeconomics
................................ ................................ ................................ ...... 35 2.3.1 Domestic Economic Environment
................................ ................................ ... 36 2.3.2 Trade Economic Environment
................................ ................................ ......... 39 2.3.3 Organically

Certified Economic Environment
................................ ................ 39 3. AL TERNATIVES
................................ ................................ ................................ ......... 41 3.1 No Action Alternative: Continuation as a Regulated Art icle
................................ 41

### TABLE OF CONTENTS **PAGE**

**(Continued)**

ii 3.2 Preferred Alternative: Determination That Simplot InnateTM Potato Is No L onger a Regulated Article
................................ ................................ ............................... 42 3.3 Alternatives Considered But Rejected from Further Consideration
...................... 42 3.3.1 Prohibit Any

Simplot InnateTM Potato from Being Released
.......................... 42 3.3.2 Approve the Petition in Part
................................ ................................ ............. 43 3.3.3 I solati on Distance between Simplot Innate TM Potato and Non
- GE Potato Production and Geographical Restrictions
................................ ................. 43 3.3.4 Requirement of Testing for Simplot InnateTM Potato
................................ ...... 44 3.4 Comparison of Alternatives
................................ ................................ ................ 44 4 ENVIRONMENTAL CONS EQUENCES
................................ ................................ .... 50 4.1 Environmental Consequences
................................ ................................ ................ 50 4.2 Scope of Anal ys is
................................ ................................ ................................ ... 50 4.3 Agricultural Production of Potato
................................ ................................ .......... 50 4.3.1 Acreage and Area of Potato Production
................................ ........................... 50 4.2.2 Agronomic Practices
................................ ................................ ........................ 51 4.2.3 Potato Seed Production
................................ ................................ .................... 52 4.2.4 Organic Potato Production
................................ ................................ ............... 52 4.3 Phy sical Environment
................................ ................................ ............................. 54 4.3.1 Water Resources
................................ ................................ .............................. 54 4.3.2 Soil Quality
................................ ................................ ................................ ...... 54 4.3.3 Air Quality
................................ ................................ ................................ ....... 55 4.3.4 Climate Change
................................ ................................ ................................ 56 4.4. Biological Resources
................................ ................................ ............................. 56 4.4.1 Animal Communities
................................ ................................ ....................... 56 4.4.2 Plant Communities
................................ ................................ ........................... 59 4.4.3 Gene Flow and Weediness
................................ ................................ ............... 60 4.4.4 Microorganisms
................................ ................................ ............................... 60 4.4.5 Biodiversity
................................ ................................ ................................ ...... 61 4.4.6 Human Health
................................ ................................ ................................ .. 61 4.4. 7 Animal Feed
................................ ................................ ................................ .... 63 4.5 Socioeconomic Impacts
................................ ................................ .......................... 64 4.5.1 Domestic Economic Environment
................................ ................................ ... 64 4.5.2 Trade Economic Environment
................................ ................................ ......... 65 5 CUMULAT IVE IMPACTS
................................ ................................ ...................... 66 5.1 Assumptions Used for Cumulative Impacts Analy sis
................................ ............ 66 5.2 Past and Present and Reasonabl y Fores eeable Actions
................................ .......... 67 6 THREATENED AND ENDAN GERED SPECIES
................................ ................. 70 Potential Eff

ects of Simplot InnateTM Potato on TES and Critical Habitat
............. 73 7 CONSIDERATION OF EXE CUTIVE ORDERS, STAND ARDS, AND TREATIES RELATING TO ENVIRONMENTAL IMPACT S
................................ ................. 77

### TABLE OF CONTENTS **PAGE**

**(Continued)**

iii 7.1 Executive Orders with Domestic Implications
................................ ....................... 77 7.3 Compliance with Clean Water Act and Clean Air Act
................................ .......... 81 7.4 Impacts on Unique Characteristics of Geographic Areas
................................ ...... 81 7.5 National Historic Preservation Act (NHPA) of 1966 as Amended
........................ 82 8 REFERENCES
................................ ................................ ................................ ......... 83iv

**LIST OF FIGURES** Figure 1. Potato Growing Regions of the U.S. (USDA
- NASS, 2007)
................................ ......... 10 **LIST OF TABLES**  Table 1. Major Potato Production States
................................ ................................ ...................... 11 Table 2.U.S. 2012 Potato Harvest b y State
................................ ................................ .................. 12 Table 3. Major Insect Pests of Potato
................................ ................................ .......................... 15 Table 4. Major Diseases of Potato
................................ ................................ ............................... 16 Table 5. Major Weeds of Potato
................................ ................................ ................................ .. 18 Table 6. U.S. Per Capita Potato Consumption in 2012
................................ ................................ 31 Table 7. U.S. 2012 Potato Utilization
................................ ................................ .......................... 34 Table 8. A Sample of U.S. Potato Varieties and their U ses ................................ ......................... 36 Table 9. Summary

of Issues of Potential Impacts and Consequences of Alternatives
................ 45v **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

–APHI S) **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** c arbon monoxide **CO 2**  c arbon dioxide **DNA** deox yribonucleic a cid **EA** e nvironmental a ssessment **EIS** e nvironmental i mpact s tatement **EO** Executive O rder **EPA** U.S. Environmental Protection Agency **ESA** Endangered Species Act of 1973 **FDA** U.S. Food and Drug Administration **FFDCA** Federal Food, Drug, and Cosmetic Act **FFP** f

ood, feed, or processing **FI FRA**  **FONSI FQ**  **PA** Federal Insecticide, Fungicide , and Rodenticide Act

Finding of No Significant Impact Food Qualit y Protection Act **FR FWS**  Federal Register

Fish and Wildlife Service (of the U.S) **GE** g eneticall y e ngineered **GHG** greenhouse gasvi **ACRONYMS AND ABBREVIATIONS IPPC**  International Plant Protection Convention **ISPM** International Standard for Phytosanitary Measure s **LMO M**  **NGO** living modified organism

Million non - government organization **NO 2**  n itrogen dioxide **N 2**  **O** n itrous 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 PI**  **P PM**  **PPA PPM**  **PPRA RNA**  **SSA TES**  **U.S. USDA**  **USDA -**  **ERS USDA**  **- FAS**  **USDA -**  **NASS** National Historic Preservation Act

National Marine Fisheries Service National Organic Program (of USDA AMS) non - point source National Research Council Plant
- incorporated protectants Particulate matter Plant Protection Act parts per million Plant Pest Risk Assessment ribonucleic acid sole source aquifer threatened and endangered species United States U.S. Department of Agriculture U.S. Department of Agriculture
- Economic Research Service U.S. Department of Agriculture
- Foreign Agricultural Service U.S. Department of Agriculture
- National Agricultural Statistics Servicevii **ACRONYMS AND ABBREVIATIONS USDA**  **- NOP**  **WPS** U.S. Department of Agriculture
- National Organic Program

Worker Protection Standard (for agricultural pesticides)1

**1 PURPOSE AND NEED**  **1.1 Background**  J.R. Simplot of Boise, Idaho, submitted petition 13
- 022
- 01p to the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) in March 2013 , seeking a determination of nonregulated status for Simplot Innate TM Potato with low acrylamide potential and reduced black spot brui se (events E12 and E24 (Russet Burbank); F10 and F37 (Ranger Russet); J3, J55, and J78 (Atlantic); G11 (G); and H37 and H50 (H)). The petitio n was deemed complete b y APHI S o n March 22, 2013. Simplot InnateTM Potato is currentl y regulated under 7 CFR part 340. Interstate movements and field trials of Simplot InnateTM Potato have been conducted under permits issued or notifications acknowledged b y APHI S since 2009. These field trials were conducted in Florida, Indiana, Idaho, Michigan, Nebraska, North Dakota, Washington, and Wisconsin. Data resulting from these fi eld trials are described in Simplot’s InnateTM Potato petition ( Simplot, 2013a) and analyzed for plant pest risk in the APHI S Plant Pest Risk Assessment (PPRA) ( USDA
- APHIS, 2013a)
. The petition stated that APHI S should not regulate Simplot InnateTM Potato because it does not present a plant pest risk. In the event of a de termination of nonregulated status, the nonregulated status would include Simplot InnateTM Potato , an y progen y derived from crosses between Simplot InnateTM Potato, and conventional potato , and crosses of Simplot InnateTM Potato with other biotechnology
- deriv ed potatoes that are no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act. **1.1 The APHIS Regulatory Authority**  As noted in 1.1.1, the PPA authorizes and mandates APHI S to regulate, manage and control plant pests. This directive includes regulatory authority over the introduction (i.e., importation, interstate movement, or release into the environment) of certain GE organisms and products. A GE organism is no longer subject to the plant p est provisions of the PPA or to the regulatory requirements of 7 CFR part 340, 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 vecto r agent used in engineering the organism belongs to one of the taxa listed in the regulation (7 CFR 340.2) and is also considered a plant pest. A GE organism is also regulated under 7 CFR 340, when APHI S has reason to believe that the GE organism may be a plant pest, or APHI S 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 the regulations at 7 CFR 340. Under § 340.6(c)(4), the petitioner must provide information related to plant pest risk that the agency can use to determine whether the regulate d article is unlikely to present a greater plant pest risk than the unmodified organism. 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 unlikely to pose a plant pest risk.2

1.1.1 Purpose of this Product Simplot InnateTM Potato is genetically engineered to silence genes that lead to acrylamide formation in cooked potatoes, and genes that cause browning in damaged potatoes. Acrylamide is a human neurotoxicant and potential carcinogen th at may form in potatoes and other starch y foods under high
- temperature cooking conditions. Black spot bruise is a post
- harvest phy siological disorder primarily resulting from the handling 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 . The 10 Simplot InnateTM Potato events were produced by using Agrobacterium
- mediated transformation of potato internode explants of 5 different varieties: Ranger Russet, Russet Burbank, Atlantic, variety G and variet y H ( Simplot, 2013a) . The binary plas mid vector pSIM1278 ( Simplot, 2013a) , consisting of the vector bac kbone ( Simplot, 2013a) and th e DNA insert ( Simplot, 2013a) was used to create all 10 events; only the DNA insert portion was intended to be transferred to the recipient plants. The DNA insert in plasmid pS 2 IM 1278 is designed to silence four different gen es in the potato: asparagine sy nthetase
- 1 (

Asn1 ), pol yphenol oxidase
- 5 (

Ppo5 ), potato phosphorylase L ( PhL ) and the starch
- associated R1 gene ( R1 ). The suppression of Asn1 should result in potatoes with reduced free asparagine, and the suppression of PhL and R1 should result in potatoes with a lower content of reducing sugars. Collectively , the silencing of these 3 genes should result in potato tubers with a reduced acrylamide potential. The suppression of Ppo5 confers the Simplot InnateTM potatoes with a non - browning phenot ype resulting in tubers with reduced black spot bruising. Black spot bruise can lead to economic losses as high as 20 % ( Partington et al. , 1999 ) ; the potato industry therefore has a vested interest in minim izing these losses. Bachem et al 1994 ( Bachem et al. , 1994 ) demonstrated that black spo t bruise can be reduced by silencing Ppo genes in potatoes, and Simplot has further developed this concept in the design of Simplot InnateTM potatoes ( Simplot, 2013a)
. The intended purpose of the 10 Simplot InnateTM potato lines is to provide the potato processing industry with new varieties with low acrylamide potential and reduced black spot bruise. Both of these changes are intended to benefit potato consumers, producers, and processors. The low acryl amide potential is intended to benefit consumers because of concerns about the health effects of ingesting acrylamide ( FDA, 2013b )
. Simplot InnateTM potatoes offer an efficient method to reduce acrylamide in the diet. The reduced black spot bruise trait is intended to benefit consumers b y provi ding a higher quality product , to benefit producers by reducing culls at delivery , and to benefit processors by reducing wastage
. Simplot InnateTM potato tubers are nutritionally and compositionally

similar to their respective parental varieties and/or other commercial potato varietie s, with the exception of the intentional changes conferred b y the introduced genes. These intentional changes fall into three broad categories: (1) reduction of PPO enzy me levels in tubers; (2) alteration of the levels of asparagine and glutamine in the p ool of free amino acids in tubers; and (3) reduction in the levels of the reducing sugars glucose and fructose in tubers ( USDA
- APHI S, 2013a)
.3

**1.2 Coordinated**  **Regulatory Framework**  **for Genetically**  **- Engineered Organisms**  The U.S. government has regulated geneticall y engineered ( GE ) organisms since 1986 under Federal regulations published in the Federal Register ( 51 FR 23302 ; 57 FR 22984 ) entitl ed “ The Coordinated Framework for the Regulation of Biotechnology” ( henceforth referred to here as the Coordinated Framework). The Coordinated Framework, published by the Office of Science and Technology

Polic y, describes the comprehensive F ederal regulato ry policy for ensuring the safet y of biotechnology research and products . It also explains how F ederal agencies will use existing Federal statutes to ensure public health and environmental safety while maintaining regulatory

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 their respective statutory authorities ; (2) agencies are required to focus on the characteristics and risks of the biotechnology

product, not the process by which it was created; (3) agencies are mandated to exercise oversight of GE organisms only when there is evidence of “unreasonable” risk. The Coordinated Framework explains the regulatory roles and authorities for the three major agencies involved in regulating GE organisms: USDA APHI S, the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). A summary of each role follows. 1.2.1 USDA
- APHIS APHI S regulations at 7 Code of Federal Regulations (CFR) part 340, which were promulgated pursuant to authority

granted by

the Plant Protection Act (PPA) , as amended (7 United States Code (U.S.C.) 7701

– 7772), regulate the 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 340 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 eng ineering the organism belongs to one of the taxa listed in the regulation (7 CFR 340.2) and is also considered a plant pest. A GE organism is also regulated under Part 340 when APHI S has reason to believe that the GE organism may be a plant pest or APHI S d oes 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 r egulated under the plant pest provisions of the PPA or the 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 present a greater plant pest risk than the unmodified organism. 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 unlikely to pose a plant pest risk
. 1.2.1 Environmental Protection Agency The EPA is responsible for regulating the sale, distribution, and use of pesticides, including those that are expressed b y an organism modified using techniques of modern biotechnology
. Such pesticides are regulated by EPA as plant
- incorporated protectants (PIPs) under the Federal4

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 containing a PIP, a company must seek an experimental use permit from EPA. Commercial production of crops containing PIPs for purposes of seed increase and sale requires a FIFRA Section 3 registr ation with EPA. Under FIFRA (7 U.S.C. 136 et seq. ), EPA requires 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 pesticide pro duct ; 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 test ing that the pesticide does n ot cause unreasonable adverse effects 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 CF R part 158. Once registered, a pesticide may onl y 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 heal th 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 standards of safet y and continue to hav e no unreasonable adverse effects ( US
- EPA, 2011d)
. 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 tol erance 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 safet y determination based on a finding of reasonable certainty of no harm under the FFDCA, as amended b y the FQPA. FDA enforces the pesticide tolerances set b y EPA. The ten Simplot InnateTM Potato events are not engineered to express substances to pro tect the potatoes against plant pests, and are therefore not subject to EPA r eview. 1.2.2 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 f rom 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 v oluntary consultation process provides a way

for developers to receive assistance from FDA in compl yi ng with their obligations under Federal food safet y laws prior to marketing. In June 2006, FDA published recommendations in “Guidance for Industry : Recomm endations for the Early

Food Safety Evaluation of New Non
- Pesticidal Proteins Produced b y New Plant Varieties Intended for Food Use ” ( US
- FDA, 2006 )
. This establishes voluntary food safet y evaluations for new non
- pesticidal proteins produced b y new plant varieties intended to be used as food, including GE plants. Earl y food safet y evaluations help make sure that potential food5

safet y issues related to a new protein in a new plant variety are addressed early in 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. **1.3 Purpose**  **and Need for This**  **APHIS Action** APHI S must respond to petitioners that request a determination of the regulated status of GE organisms (7 CFR 340.6) , including GE p lants such as Simplot Innate TM Potato . When a petition for nonregulated status is submitted, APHI S must determine if the GE organism is unlikely to pose 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 be a greater plant pest risk than the unmodified organism. 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 APHI S determines that it is unlikely to pose a plant pest risk. APHI S must respond to this petition from Simplot requesting a determination of nonregulated status for Simplot InnateTM Potato . AP HI S has prepared this EA to consi der the potential environmental e ffects of an agency determination of nonregulated status of Simplot InnateTM Potato . This action is consistent with regulations for the National Environmental Policy Act (NEPA) established b y the Council of Environmental Quality (CEQ) , and those of the USD A APHI S NEPA
- implementing regulations and procedures (40 CFR parts 1500
- 1508, 7 CFR part 1b, and 7 CFR part 372). This EA has b een prepared in order to specificall y evaluate the effects on the quality

of the human environment that may result from a determ ination of nonregulated status for Simplot InnateTM Potato
. 1.3.1 Public Involvement APHI S routinel y 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 published 1 in the Federal Register , 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 earl y public involvement in the process
. As identified in this notice , APHI S publish es two separate notices in the Federal Register for petitions for which APHIS prepares an EA. The first notice announce s the availability of the petition; the second announce s the availability

of the APHI S 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 EA and PPRA. Th e availability

of the petition for public comment is announced in a Federal Register notice.

1 This notice can be accessed at: http://www.gpo.gov/fdsys/pkg/FR
- 2012
- 03
- 06/pdf/2012
- 5364.pdf6

**S** econd Opportunity

for Public Involvement If an EA is determined to be sufficient, the PPRA and EA are developed , and a notice of their availability is published in a second Federal Register notice. This second notice follows one of two approaches for public participation based on whether or not APHI S de termines the petition for nonregulated status for a GE organism involves substantive new issues: Ap proach 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 anal ys is of public submissions received during the 60
- day comment period for the petition, that the GE organism does not involve new biological, cultural, or ecological issues
. Agency criteria for this decision 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, APHI S conducts the necessary analy sis 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

determination 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 anal ys is and determination, the Agency ’s preliminary regulatory

determination become s effective . No further Federal Register notices are published announcing the final regulatory determination. The Agency post s this public notification in an announcement on the APHI S website. Approach 2. For GE organisms involving substantive new issues not previously anal yz ed
. 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 ident ical with or sufficiently similar to organisms determined previously by

APHI S to have nonregulated status
. Examples include organisms with new gene modifications that could have substantial biological, cultural, or ecological effects not previously anal yz ed. For this process, APHI S 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. APHI S review s and evaluate s comments and other relevant information, then rev ise s the PPRA as necessary and prepare s a final EA. Following preparation of these documents, APHI S 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 d ecision document, and regulatory determination. More details about this expansion of opportunities for stakeholder review and comment are available in the Federal Register notice 2 published on March 6, 2012
.

2 This notice can be accessed at: http://www.gpo.gov/fdsys/pkg/FR
- 2012
- 03
- 06/pdf/2012
- 5364.pdf7

1.3.2 Public Involvement Approach for This EA APHI S has de termined that the protocol for preparation of this EA will follow Approach 2. The issues considered in this EA were developed by reviewing the public concerns, including public comments received in response to the Federal Register notice on May 3, 2013 ( 78 FR 25942
- 25943 ) announcing the availability of the petition ( i.e., the first opportunity for public involvement previously

described in this document) . 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, includi ng those regarding the agricultural production of Simplot InnateTM Potato 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 Potato
. T he public comment period for the review of this petition for nonregu latory status of Simplot Innate TM Potato closed on July 2, 2013
. At its closing, the docket file contained a total of 308 public comments . Th ese were screened and sorted into categories a ccording to the subject matter addressed (e.g., air, water, soil impact s) , and classified as either non
- substantive or substantive. Most of the comments that expressed a general dislike of the use of GE organisms were non - substantive . One comment from a non - governmental organizatio n (NGO ) had 41,475 signatures appended to it. Eight y - five of the comments supported the petition, citing potential improved health benefits to consumers and decreased wastage of potato as economically beneficial to the potato industry
. The majority

of the negative comments expressed a general dis like of the use of GE organisms. This issue is outside the scope of this EA. The issues that were raised in the public comments which were related to the Simplot InnateTM Potato petit ion included:  Contamination of conventional potato production
.  Concerns that more research should be done prior to approval of the petition.  Concerns that plant fitness will be negatively affected.  Impact that petition approval may have on export markets. APHI S has anal yz ed and evaluated the issues described in these comments, and has included a discussion of these issues in this EA with citations where appropriate. **1.4 Issues Considered**  The list of resource areas considered in this EA were developed b y 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 considered also address concerns raised in previous and unr elated lawsuits, as well as issues that have been raised by various stakeholders for this petition and in the past. The resource areas considered in this EA can be categorized as follows:8

Agricultural Production Considerations:  Land Use of Potato Produ ction  Agronomic/Cropping Practices  Potato Seed Production  Organic Potato Production Environmental Considerations:  Water Resources  Soil  Air Quality  Climate Change  Animals  Plants  Gene Flow  Microorganisms  Biological Diversit y Human Health Considerations:  Public Health  Worker Safet y Livestock Health Considerations:  Livestock Health/Animal Feed Socioeconomic Considerations:  Domestic Economic Environment  Trade Economic Environment APHI S evaluated these raised issues and the submitted documentation. APHI S ha s also included a discussion of these issues in this EA.9

**2 AFFECTED ENVIRONMENT**  This section includes a review of the prevailing conditions of the human environment that might be impacted b y Simplot Innate TM Potato production. Relevant environmental compone nts include agricultural production area of Simplot Innate TM Potato , the phy sical 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 ) ( Ll orente et al. , 2011 )
. Potato is grown in over 100 countries , with w orld potato production exceeding 300 million metric tons ( Center, 2010 )
. 2.2.1 Land Use Potatoes are grown across most of the continental U
. S
. , with seven States (Colorado, Idaho, Minnesota, North Dakota, Oregon, Washington and Wisconsin) accounting for approximately 77 % of annual production ( USDA
- APHIS, 2013a ) (Figure 1). Within recent ye ars, land devoted to potato production has shifted from the East and Midwes t to the Pacific Northwest. This shift has resulted from a number of factors, including improvements in the U.S. transportation sy stem, the relative decline in consumption of fresh potatoes coupled with advantages associated with processing potatoes in the Northw est such as lower taxes, and lower power and labor costs, more favorable weather , and available land for acreage. The largest potato
- growing region b y far in the U.S. is the Snake River Plain of southern Idaho, a major agricultural area where water is ava ilable f

or irrigation, where nearl y all the Idaho crop is grown ( Bechinski 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 between the northern borders of North Dakota and Minneso ta (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 Potato events may

be grown in any

of the U.S. potato
- growing regions.10

**Figure 1**  **.** Potato Growing Regions of the U.S. **( USDA**  **- NASS, 2007**  **)** Potato 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 acreage has declined over the years, total production has increased ( Guenther, 2010a )
. For example, in the 1930s, from about 3.5 million acres of potatoes were harvested, whereas by 1985, production had nearl y 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 193 0s acreage ( Guenther, 2010a )
. Total annual U.S. production has been over 400 million CWT (one CWT = 100 pounds) every year since 1990, with a peak of 513,544,000 CWT in 2000 ( USDA
- NASS, 2012c ) . 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 ; 2013 )
. The top ten potato producing states shown in Table 1 account for almost 83 % of the United St at es potato crop ( USDA
- NASS, 2013 )
. Highest yields are in regions where day time temperatures exceed 100° F during the hottest part of growing season, and where nights are cool (about 65 ° F), such as in Washington’s Columbia Basin, eastern Oregon, California, and Nevada ( Rosen, 2010d )
.11

**Table 1**  **. Major Potato Production States**  State Production (1,000

CWT) Percent of Total

U.S
. Production Id aho 141,820 30.6 Washington 95,940 20.7 Wisconsin 29,440 6.4 North Dakota 25,200 5.4 Colorado 23,365 4.8 Minnesota 18,800 4.1 Michigan 15,925 3.4 Maine 15,675 3.4 California 15,501 3.3 Oregon 2,236 0.4 Source: ( USDA
- NASS, 2013 ) Most potatoes are harvested in July through October. Fall crops have increased because of demand for processing ( Guenthe r, 2010a)
. Harvested potatoes are either used for food (~93%), feed (<1%), industrial purposes (<1%) or as “seed” for planting (5%) (NPC, 2012b ; USDA
NASS, 2013 )
. Usage is partially dependent on a variet y of characteristics related to tuber qualit y. Only about one quarter of U
. S
. potatoes are consumed fresh ( USDA
- NASS, 2013 ) , while approximately 60% of annua l output is processed into frozen products (such as frozen fries and wedges), chips, deh ydrated potato and starch (11%) , canned potatoes (0.4%), and 6% is replanted as seed potato. Americans eat, on average, approximately 112 lb (51 kg ) of potatoes per per son per y ear (NPC, 2012b )
. Raw potato waste products (peels, out of specification raw potatoes, or other non
- processed raw potato pro ducts) and processed discards (French fries, hash brown, etc.) are routinely incorporated into feed rations at livestock feedlot operations ( Simplot, 2013a)
. U.S. 2012 potato harvests by state are summarized in Table 2 (in acres)
.12

**Table 2**  **. U.S. 2012 Potato Harvest by State**  **State Acres Of Potato Harvested**  Idaho 344,000 Washington 164,000 North Dakota 84,000 Wisconsin 64,000 Colorado 59,300 Maine 57,000 Minnesota 47,000 Michigan 45,500 Oregon 41,700 California 37,300 Florida 36,600 Nebraska 23,300 Texas 20,100 New York 16,500 North Carolina 16,000 Montana 11,700 Missouri 8,900 Pennsylvania 8,700 Illinois 7,400 Kansas 5,200 Virginia 4,800 Massachusetts 3,900 Arizona 3,700 **Total 1,134,550**  Source: ( USDA
- NASS, 2013 ) 2.2.2 General Agronomic Practices USDA classifies potato production by season, according to the period when the largest sup plies are har vested . Winter, spring and summer potatoes are harvested while the vines are still green and the tubers comparatively immature. These potatoes go directl y from the field to fresh markets or into processing. Fall potatoes are usuall y 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 percent age of the fall crop is stored for processing and fresh market through the winter, spring and summer13

months. Many

modern storage facili ties 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 management i s integral to obtaining optimum quality and yi eld 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 easternmost regions of the U.S. ge nerally receive enough ra infall in order to produce good quality and yi eld of potatoes, whereas the western part of the country t ypically relies on some form of irrigation. Specific guidelines for irrigation depend on geographic region and factors ty pical of that region such as temperature, relative humidity , and daylength. Water requirements also vary to some degree with cultivar. Most potato
- 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 i ncrease water use efficiency by avoiding steepl y sloping fields for planting, and b y preparing the soil so that infiltration of water is increased, and b y also 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 potato production. Some phy sical 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 yi eld 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 emerge nce of plants to approximately two weeks after row closure, but then decline rapidl y after onset of vine maturation ( DEFRA, 2006 ; Shock, 2010 ) . Potatoes need more water during tuber initiation and earl y tuber development. At harvest, soil water content is also imp ortant to reduce mechanical damage to tubers which are frequently associated with dehydration such as blackspot bruise, and excess water such as shatter bruise and thumbnail cracking ( DEFRA, 2006 ; King and Stark, No Date )
. Potato Breeding The tetraploid nature of commercial potato varieties is a significant impediment to potato breeding , as well as biological factors su ch as inbreeding depressi on, and cy toplasmic and nuclear sterility ( Hoopes and Plaisted, 1987 ; Arvanitoyannis et al. , 2008 )
. Due to complex chromosome segregation ratios, poly ploid 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 soy bean, trait developers often create a single elite event and then b ackcross that elite event into a wide range of elite germplasm. This is not possible in potato. Each parent variet y must be independentl y transformed to achieve the desired phenoty pe in that variet y ( USDA
- APHIS, 2013a)
. If a sing le14

variet y was transformed, it c ould take decades to move these new traits into the other commercial varieties b y conventional breeding, and even then, it would be difficult to reconstitute the desirable characteristics of the original variet y ( Llorente et al. , 2011 ; USDA
APHI S, 2013a )
. Because maintenance of a vegetativel y propagated, disease
- and insect
- free genetic stock is difficult, much of the genetic base is kept as true seed populations ( Spooner, 2010 )
. Cultivation Potatoes ty

picall y 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 , heav y field traffic and long periods of soil being left bare ( Hopkins, 2010 ) . In the Northwest, potato fields are t ypicall y 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 plantin g 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, 201 0 )
. Subsequent to mowing the cover crop , the residues may be left on the field to minimize wind erosion ( Rosen, 2010b )
. Another method of reducing erosion as well as mitigated disease pressure is to till green manure crops into the soil prior to planting ( Hopkins et al. , 2004 )
. Growers in Florida use Sudan grass as a cover crop to provide nitrogen prior to potato planting ( Mossler and Hutchinson, 2011 )
. Growing cover crops can also increase yi eld of the subsequent cash crop ( University , 2013 )
. Crop Rotation One of the challenges that growers face is the high short
- term economic demand for po tatoes to be grown continuousl y , partly because of the investment that is put into the specialized equipment used in potato growing, and because potatoes represent the highest potential gross return per acre ( Hopkins et al. , 2004 )
. C ontinuous cropping, and short rotations of this crop along with o thers, causes potato crops to become more susceptible to complications and increases the risk of insect , disease, and nematode pressure, decrease in soil nutrient levels, and an increase in eros ion potential ( Hopkins et al. , 2004 ) ( Delahaut, 2000 ; Hall et al. , 2000 ) ( Bennett and O'Rourke, 2002 ; Larkin, 2003 )
. Lo wer 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 ) ( Universit y, 2013 ) in order to increase 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 ye ar. Rotation crops vary with geographical region:15

for example, in I daho, 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, sma ll grains, legumes and green manure crops in Wisconsin ( Delahaut, 2000 )
. Insect Control The potato crop is intensively managed with integrated pest management (IPM) to control a variet y of insect and disease ( Johnson, 2007b )
. More than 150 species of insects may damage potatoes, most of which cause onl y minor economic injury . However, several species cause economic injury

through feeding on foliage, tub ers, or roots, or b y transmitting disease pathogens to the plant. While major insect pests vary within production regions, the most serious overall is th e Colorado potato beetle. In the eastern U.S., leafhoppers can also cause yi eld loss to plants before plants present an y visual sy mptoms of feeding damage; several leafhopper species are serious problems because they vector phy

toplasmas ( Radcliffe, 2010 )
. Aphid
- transmitted diseases cause greater economic losses than all other insect damage combined together. At least 9 potato viruses are tra nsmitted via aphids , the most important of which is potato leaf roll virus (PLRV), vectored primaril y by green peach aphid, and potato Y virus (PVY), vectored b y potato aphid, pea aphid, melon aphid, buckthorn
- potato aphid, soy bean aphid, and bird cherry
- o at aphid ( Radcliffe, 2010 ; Rondon, 2012 )
. Occasional pests include army worm, loopers, cutworms and spider mites ( Rondon, 2012 )
. Some soil insects can cause a decrease in quality of tubers, but generall y cause little decrease in yi eld. The m ost important of these are wireworms, the larval stage of elaterid beetles ( Bechinski et al. , 2001 ) , p articularl y if fields are laden with sod sometime before planting ( Roberts and Cartwright, No Date
- a)
. Growers may

also mitigate insect pressure b y avoiding planting on fields nearb y 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**  **. Major**  **Insect Pests of Potato** Common Name Scientific Name Colorado potato beetle Leptinotarsa decemlineata Green peach aphid Myzus persicae Wireworm s Limonius californicus, L. canu, Ctenicera pruinera Potato leafhopper Emposasca fabae Pea aphid Acyrthosiphon pisum Soy bean aphid Aphis glycine Thrips Franklinella spp., Thrips spp. Flea beetle Epitrix spp. European cornborer Ostrinia nubilalis16

Potato psyllid Bactericera (Paratrioza) cockerelli Potato Tuberwo rm

or Tuber Moth Phthorimaea operculella Sources: ( Radcliffe, 2010 ; Rondon, 2012 ; Roberts and Cartwright, No Date
- a) Disease Control Potato d iseases can be caused by viruses, viroids, phytoplasmas, and most importantly , by bacteria and fungi
. In fection 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 wounds 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, IP M options for virus pests are limited to insecticidal control of their insect vectors and planting of resistant varieties, including some GE varieties ( Arif et al. , 2012 ; Arif et al. , 2012 ; USDA
- APHI S, 2013a)
. There are several factors to consider in controlling potato diseases, including part of the plant being attacked, pathoge n transmission mechanism, and environmental conditions . Table 4 lists the major diseases of potato. Some of these are more common while plants are in the field, while others only

emerge during storage ( Bechinski et a l. , 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 Date )
. **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

Potato Spindle Tuber Viroid Member of Pospiviridae Potato Virus A,M, X, Y Members of Potyviridae, Carlavirus, Tobacco Rattle Virus Tobravirus **Fungi** Late blight Phytophora 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. S epedonicus Powdery scab Spongospora subterranea Silver scurf Helminthosporium solani Wart Synchytrium endobioticum **Nematodes** Golden nematodes Globodera rostochiensis Potato tuber rot Ditylenchus destructor Root knot Meloidogyne spp. Columbia root knot Meloidogyne chitwoodi Root lesion Pratylenchus penetrans Sources: ( Johnson et al. , 2010 ; Roberts and Cartwright, No Date
- a) Weed Management Weeds pose a management issue for growers, potentially causing a significant loss in yield by outcompeting potatoes fo r nutrients, water and sunlight. T illage and herbici de usage can help control weeds ( Delahaut, 2000 ) ; ( Hutchinson, 2010 ) , although tillage can also damage potato plants and reduce yi elds
. 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 annua ls; and perennials, which are the most difficult to control ( Hutchinson, 2010 ; University , 2013 )
. Major weed species in potato18

fields are noted in Table 5 . In addition to competition with potato plants for resources, weeds are detrimental to the crop due to potential penetrat ion 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 Perennials Hairy nightshade ( Solanum sarrachoides ) Common lambsquarters ( Chenopodium album ) Redroot pigweed (

Amaranthus retroflexus ) Ragweed (

Ambrosia artemisiifolia ) Kochia (Kochia scoparia ) Pennsylvania smartw eed (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 mitigate weed problems, growers should avoid planting potatoes on fields with heav y infestations of weeds. Most growers also scout their fields to assess the need for herbicides, and choose rotational crops that compete successfull y with weeds ( Bechinski et al. , 2001 )
. Commonly

used herbicides are metribuzin, EPTC, and meto lochlor ( Bechinski et al. , 2001 ) , ( USDA, 2000 ) ( 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 tuber s that are left 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 suc h as late blight, potato leaf roll, and virus Y ( Eberlein et al. , 1998 ; Bo ydston and Williams, 2005 ) . Several herbicides can be used for the control of volunteer potato plants ( ( Bo ydston 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 ecosy stems. 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 again, there is little probability of successful establishment ( OECD, 1997b )
. Organic Potatoes To bear a certified organic label, farms grossing more than $5,000/year in revenues must be certified b y a USDA National Organic Program (NOP) accredited certifying agency
. .19

Certifying agencies also have specific cultural requirements with regard to f ield selection (e.g., fields cannot have been treated with prohibited chemicals for 3 ye ars before harvest of a certified organic crop, and there must be sufficient buffer zones between certified organic crops and conventionally

grown crops in order to reduce potential contamination between the two such as via pollination) ( University , 2013 )
. There are other re quirements and recommended practices for organic potato production see, e.g., ( Moore and O lsen, No Date ) for organic potato production in Id aho, and ( H ollingsworth, No Date ) for organic potato production in California. In terms of US 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) (reference from Omar). 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 2.3.1, Domestic Economic Environment, organic potatoes command a premium price comp ared to conventionally grown potatoes. Potato Seed Production Potatoes are vegetativel y propagated by planting tubers or seed pieces ( Davidson, 2010 ) (NSF, 2011 ) . In 2012, approximately 6 percent of the 2012 annual potato crop wa s used as seed (NPC, 2012a) in the form of seed potatoes. Certified seed potatoes are produced to ensure genetic purity and to r educe disease introduction (NPC, 2012a) . Most seed that is sold is labeled 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 whethe r disease incidence exceeds established thresholds ( Moore and Olsen, No Date )
. There ar e 16 potato seed certification agencies in the U.S., including one in each major production state (NPC, 2012a)
. Ty picall y, 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 2012 in order of de crea sing production were Idaho (>35,000 acres harvested), North Dakota, Colorado, Maine , Wisconsin and Minnesota (>7,000 acres harvested) ( USDA
- NASS, 2013 )
. The use of good quality

seed potatoes is important to successful potato culture. It is recommended that seed size be ideally about two to four ounces, about the size of a golf ball ( Hollingsworth, No Date )
. Potato Processing and Storage About 60% of potatoes are processed into frozen commodities such as French fries and shoestring potatoes and dehydrated. Ty picall y, frozen and deh ydration industries are concentrated in the Northeast, upper Midwest, and Pacific Northwest. Potato chip processers tend to be more evenly

distributed throughout the country because chips are fragile , and long
distance shipping is expensive. Therefore, chipping plants tend to be located near heavil y populated area s ( Guenther, 2010b )
.20

Long
- term storage is needed for processing operations. Capacities of storage facilities ty picall y range from 500 to >20,000 tons. Most of the tubers are kept in bulk piles, but some facilities use box storage. In northern production ar eas, 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 ventilation sy stems and s ys tems to monitor temperature, relative humidi ty

and carbon dioxide levels. Some storage facilities are refrigerated to cool stored potatoes during w armer spring and summer months ( Olsen, 2010 )
. Potatoes kept stored for > 130 day s 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 )
. **2.3 Physical Environment**  2.3.1 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 qualit y standards, permitting r equirements, and monitoring to protect water qualit y. The EPA sets the standards for water pollution abatement for all waters of the U.S. under the programs contained in the CWA, but, in most cases, gives qualified states the authority to issue and enforc e permits. Drinking water is protected under the Safe Drinking Water Act of 1974 (Public L aw 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 b y depositing sediment, minerals, or contaminants into surface water bodies. Surface runoff is influenced b y meteorological factors such as rainfall intensity and duration, and phy sical factors such as vegetation, soil ty

pe, and topography
. Agricultural production, including potatoes, can adversel y impact surface water quality , primaril y through sedimentation from erosion and nutrient loading from fertilizers ( ( US
- EPA, 2005b ) ( US
- EPA, 2009a)
. Nitrogen loss in the form of ammonium and nitrates to surface water can occur as a result of direct runoff, or b y infiltration through the root zone, and discharge to surface water b y 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 ecos ys tems by releasing a constant supply of water into wetlands and contributes a sizeable amount of flow to permanent streams and rivers. Based on 2005 data, the largest use of groundwater in the U.S. is irrigation, representing approximately 67.2% of all the groundwater pumped each day ( McCray , 2009a ; McCray , 2009b ) . In the U.S., 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 a lternative sources to the groundwater resource. There are 77 designated SSAs in the U.S. and its territories ( US
- EPA, 2011e )
. Crop production has the potential 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,21

2006 )
. Agricultural production leads to nitrate contamination of groundwater through leaching associated with high applications of manure or fertilize rs or excessive irrigation ( Zebarth et al. , 1999 ) ( DEFRA, 2006 ) Unlike a point source which is a “discer nible, confined and discrete conveyance”, nonpoint source (NPS) pollution comes from man y 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. The p ollutants may eventuall y be transported b y runoff into lakes, rivers, wetlands, coastal waters and ground waters. Agricultural NPS pollution includes animal wastes, fertilizers, and pesticides. Surface water may be contaminated by

agricultural sediments transported b y erosion that may also include pesticides, fertilizers, and sometimes fuel and pathogens. Agricultural practices that introduce contaminants into the groundwater include fertilizer and pesticide application, spilled oil and gasoline from far m 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 wetlands, and a major contributor to groundwater contamination ( US
- EPA, 2005a ; 2005b ) . Management practices that contribute to NPS pollution include the ty pe 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 waters following soil erosion ( US
- EPA, 2005a ; 2005b )
. The major contribution to groundwater contamination derives from agricultural areas (nitrogen inputs from fertilizer and manure drainage 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 b y 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 agri culture listed as the third most probable source of the impairment ( US
- EPA, 2012b )
. Agricultural pollutants released b y 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, 2005a ; 2005b ) . Increase in sediment loads to surface waters can directl y 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 erosion
mediated sedimentation can increase fertilizer runoff, thereb y increasing nutrient loading and facilitating higher water turbidity , algal blooms, and oxygen depletion ( Skaggs et al. , 1993 ; US
EPA, 2005a ; 2005b )
. O ver - fertilization should be avoided to prevent nutrient leaching into groundwater, risk of ground water pollution with nitrates , 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 )
.22

Most of the potatoes produced in the U.S. ar e grown under irrigation , including potatoes grown in I daho, Washington, Oregon, California, and Wisconsin, whereas r ainfall provides adequate moisture for potato crops in the eastern U.S. ( Shock, 2010 ) ( King and Stark, No Date )
. Potato yi eld can be reduced by

both under
- and over
- irrigating ( King and Stark, No Date )
. Potato processing can contribute to eutrophication of water ( DEFRA, 2006 )
. 2.3.2 Soil Quality Soil consists of solids (minerals and organic matter), liquids, and gases. This body of inorganic and organic matter is home to a wi de variety of fungi, bacteria, and arthropods, as well as the growth medium for terrestrial plant life ( USDA
- NRCS, 2004a ; 2004b )
. Soil is characterized by its layers that can be distinguished from the initial parent material due to additions, losses, transfers, and transformations of energy and matter ( USDA
- NRCS, 1999b ; 1999a) . It is further distinguished by

its ability to support rooted plants in a natural environment. Soil play s 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
. Soils 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, th e carbon
- nitrogen ratio, numbers of microorganisms and soil fauna all vary seasonally , as well as over extended periods of time ( USDA
- NRCS, 1999b ; 1999a) . Soil texture and organic matter levels directl y influence its shear strength, nutrient holding capacit y, and permeability . Soil taxonomy was established to classify soils according to the relationship between soils and the factors responsible for their character ( USDA
- NRCS, 1999b ; 1999a) . Soils are organized into four levels of classification, the highest being the soil order. Soils are dif ferentiated based on characteristics such as particle size, 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 level for the entire U.S. and its territories. There are a multitude 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 (filamentous bacteria) ( Doran et al. , 1996a ; Doran et al. , 1996b )
. The extent of the diversity of microorganisms in so il 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 struc ture formation; decomposition of organic matter; toxin removal; and the cycling of carbon, nitrogen, phosphorus, and sulfur ( Bruinsma et al. , 2003 )
. In addition, certain microbial organisms may contribute to the protection of the root system against soil pathogens ( Garbeva et al. , 2004a ; Garbeva et al. , 2004b )
. Potatoes grow well in a wide range of soils. Optimum soils are deep, loose, and drain well ( Rosen, 2010c ) . Poorl y drained soils tend to yield poorly shaped tubers and tubers which are23

susceptible to diseases l ike tuber rot ( Johnson and Sideman, 2006 ) ( Plissey and Erhardt, 2000 )
. Sandy soils can also produce high
- qualit y potatoes, but these soils are more susceptible to wind erosion ( Rosen, 2010b )
. The ability of soils to re tain 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 better pen etration 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 residue s 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 Main e , removal of stones may ease movement of mechanical harvesters, but may also negativel y affect tuber yi eld ( Saini and Grant, 1980 ) . Soil compaction can occur with excessive tillage ( Roberts and Cartwright, No Date
- b ) , 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 ox ygen diffusion rate to roots decreases, which in turn may lead to a reduction in tuber size and increased soil erosion ( Saini and Grant, 1980 ) . Compacted soil also reduces the ability of roots to find water in soil ( DEFRA, 2006 )
. 2.3.3 Air Quality The Clean Air Act (CAA) requires the maintenance of National Ambient Air Quality Standards (NAAQS). The NAAQS, developed b y the EPA to pro tect 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 th an 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 nati onal standard and each is also required b y EPA to prepare a State Implementation Plan (SIP) containing strategies 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 designated as attainment areas. Non
- attainment areas are t ypicall y associated with large metropolitan areas with many mobile (e.g., vehicle) and stati onary (e.g., power plants and factories) sources. Other than emissions from mobile sources, crop farming emission sources are not specificall y 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 ( US
- EPA, 2011f

) . Regulation of agricultural sources within a State Implementation Plan does not appear to be t ypical. For example, base d on a review of the available plans in I daho,24

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, 2011f )
. Ammonia may

be lost to the atmosphere via inorganic nitrogenous fertilizers, but occurs mostl y from livestock production processes such as manure storage and application. Atmospheric ammonia can then contribute to the eutrophication of surface water and acidification of soil and water ( Zebarth et al. , 1999 ) The US EPA regulates mobile source emissions by reformulated gasoline and automobile pollution control devices ( US
- EPA, 2011f ) . Stricter requirements, such as vapor recovery nozzles on gas pumps, may appl y in non
- attainment areas. 2.3.4 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) and indirect (e.g., agricultural
- related soil disturban ce) 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

in the atmosphere, human activity has significantl y i ncreased 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 industrial and consumer consumption expanded greatl y. 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 US EPA converts all g ases 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 US EPA classifies different sources by sector, with the energy

sector being the largest contributor of greenhouse gas emiss ions ( US
- EPA, 2012a) . The agriculture sector, as defined b y US EPA, represented 6.3 percent of total greenhouse gas emissions for the U.S. in 20 10 ( US
- EPA, 2012a) . However, this does not in clude 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
- powered agricultural equipment (which are included in the energy sector). The primary greenhouse gases contributed by the agriculture sector as defined by US EPA are N 2 O and CH 4 . The relative percent contribution to total CO 2 e quivalent emissions of the various agricultural so urces in 2010 was as follows: agricultural soil management (fertilizer application and other cropping practices that contribute N 2 O), 49 percent; enteric fermentation (primarily methane emissions from cattle), 33 percent; manure management, 16 percent; an d rice cultivation, two percent. 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 p ercent of the total ( DEFRA, 2006 ; US
EPA, 2012a)
.25

**2.4 Biological**  **Resources** This section provides a summary of the bio logical 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
. 2.4.1 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 s hellfish. 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 Reserve Program areas ( USDA
- NASS, 2012b ) . How these lands are maintained influences the function and integrity of ecos ys tems 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 reports of wildlife feeding on foliage of 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, 1987a) . In 1992 , APHI S 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, 2013d) . 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 ) ( Taylor, 2014 ) . USDA
APHI S Wildlife Services has also received complaints for damage caused by sandhill cranes ( USDA
- APHIS, 2013d)
. There are numerous insects found in and around potato fiel ds. Some insects and other invertebrates can be beneficial to potato production, providing services such as nutrient cycling and preying on plant pests. As discussed in Section 2.2.6, Insect Control, many insects and invertebrates are detrimental to po tato 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, 2007a ; Simplot, 2013a) . Nematodes can also be found in potatoes such as the root knot nematodes (

Meloidogyne spp. ), and cy st nematodes ( Globodera pallida ) and ( G. rostochiensis ) ( Hard y, 1996 )
. The potato crop is intensively managed with integrated pest manageme nt (IPM) practices to control these insect s, nematodes, and several disease pathogens that include fungi, bacteria and viruses ( Johnson, 2007b ) and to e nhance potato yi eld . 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 broad
spectrum insecticides are potentially toxic to invertebrates and vertebrates. The US
- EPA requires application control measures for certain Restricted Use insecticides to limit human and environmental exposure . These impacts can affect animal communities, with those communities26

within and in close proximity to potato fields experiencing the greatest impact ( US
- EPA, 2000 ) , ( US
- EPA, 2009b )
. 2.4.2 Plant Communities The landscape surrounding a potato field may be bordered b y other potato fields, other crops, or may be surrounded by

forest, grassland, bodies of water, or built
- up areas. As dis cussed in Section 2.2, most commercial potatoes are grown in large agricultural areas, such as the Snake River Valley

in Idaho. Thus, other crops would most frequentl y make up the surrounding vegetation, although some fields would be bordered by non - crop v egetation. Growers may provide buffer zones to reduce or prevent impact to adjacent vegetation. Because potatoes are grown throughout much of the U.S., a wide variety of plants may

be found adjacent to the agricultural fields. These plants have the pote ntial to be impacted by agricultural practices, including the use of pesticides, which are regulated by US EPA. Aquatic plant communities near agricultural fields may

be affected b y s edimentation resulting from erosion, or by nutrients leached from fertil izers. Plants which compete with potato in crop fields are generally regarded as weeds, and are discussed in Section 2.2.8, Weed Management. Native or wild plant species related to cultivated potatoes are of interest because of the potential for interbreeding through gene flow. By definition, interbreeding between species that result in viable offspring is not common, otherwise the two plants would not be classified as different species. Interbreeding can occur to a limited extent between some spe cies under some circumstances. Among the man y factors that must be present for h yb ridization 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 overlap, and 3) ap propriate pollinat ors must be present ( OEC D, 1997b )
. Section 2.4.3, Gene Flow and Weediness discusses this subject. Threatened and Endangered Species There are currently

three plants in the genus Solanum on the U.S. Fish and Wildlife Service (US FWS) list of threatened or endangered plant sp ecies: Erubia ( S. drymophilum ), found onl y in Puerto Rico; and popolo ku mai ( S. incompletum ) and Aiakeakua popolo ( S. sandwicense ), both found only

in Hawaii ( FWS, 2011 ) p. 47). Based on the evaluation of wild potatoes presented above, these species would not interbreed with cultivated potatoes; addition ally , potatoes are not commerciall y grown in these areas. 2.4.3 Gene Flow and Weediness Gene flow is a biological process that facilitates the production of h ybrid 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
- ecos ys tem can occur on both spatial 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 temporall y and spat ial l y .27

The rate 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 s pecies; overlap of flowering phenology

between populations; the method of pollination; the biology and amount of pollen produced; weather conditions, including temperature, wind, and humidity ( Zapiola et al. , 2008 )
. Seed
- mediated gene flow also depends on man y factors, including the ab sence/presence/magnitude of seed dormancy ; contribution and participation in various dispersal pathway s; envir onmental conditions an d events. Volunteer potatoes arise from overwintered tubers, and can be a weed problem in the following crop. Potatoes have a fairly low frost tolerance, and tubers planted too shallowly are subj ect to loss by frost. In 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 easil y 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 ( OECD, 1997b ) ( Holm and Pancho, 1979 ) ( Muenscher, 1980a) ( Love, 1994b )
. Gene flow by

hy bridization is not possible for some potato cultivars such as the Russet Burbank, the most commonly

grown potato, because they are sterile (NSF, 2011 ) , ( PAA, 2009a) ( Simplot, 2013a)
. Pollination of potato is mostly by insects such as such as bumblebees ( B ombus impatiens ) ( OECD, 1997b ) , which have a relatively short flight ran ge, and, therefore, pollen dispersal is limited
. Because potato flowers have little nectar, the honey bee ( Apis mellifera ) is not attracted to them, and wind play s an insignificant role in pollination ( OECD, 1997b )
. Empirical field testing of outcrossing distances in potato show that separati ons of 20 meters or more are sufficient to prevent outcrossing ( Conner and Dale, 1996 )
. Of the fertile varieties , which include Ranger Russet, Atlantic and “G” , about 80 to 100 percent 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 fruiting bodies formed on the potato vine. Its major disadvantage is that it segregates for numerous traits because potato is highl y heteroz ygous, and plants arising from TPS ty pically take longer to establish and set tubers, resulting in low er yi eld than from seed potatoes ( Simplot, 2013a) ( Pallais, 1987 )
. Of the five parent varieties used to develop the 1 0 Simplot InnateTM Potato events , Russet Burbank and “H” are fu lly sterile, precluding any possibility

of TPS production. However, the Simplot InnateTM Potato events derived from Ranger Russet, Atlantic and “G” are fertile and may produce TPS. But plants produced from TPS are no weedier than volunteer plants produced from over
- wintered tubers and are relativel y eas y 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 ) ( OECD, 1997b )
. 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, 1997b )
. While there appears to be minimal, if any , ove rlap geographically between cultivated and wild potatoes in the U.S., there is a possibility that a few wild potato plants may be growing near28

potato fields ( Love, 1994b )
. However, the potential for hy bridization between wild and domesticated potatoes is extremely unlikel y. Approximately 200 species of wild potatoes have been identified ( Hijmans and spooner, 2001 ) , but only two species grow within US borders, the tetraploid species Solanum fendleri (recentl y reclassified as S olanum stoloniferu m ) and the diploid species Solanum jamesii ( Bamb erg et al. , 2003 ) ; ( Bamberg and del Rio, 2011 ) . In addition to geographic separation ( US
- EPA, 2011c ) , there are several biological barriers to gene transfer such as multiple ploidy levels and endosperm imbalances ( Love, 1994b )
. Hy bridization between native and cultivated potatoes has never been reported in the US , although gene transfer has been accomplished using special laboratory techn iques ( Love, 1994b ) ( US
- EPA, 2011c )
. 2.4.4 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. , 2004a ) and maintenance 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. , 1996a) ( In ceoglu et al. , 2013 )
. The main factors affecting microbial population size and diversity include soil ty

pe (texture, structure, organic matter, aggregate stability , pH, and nutrient content), plant ty pe (providers of specific carbon and energy sources into the soil), and agricultural management practices (crop rotation, tillage, irrigation and herbic ide and fertilizer application) ( Garbeva et al. , 2004a ; Garbeva et al. , 2004b ) ( Rosen, 2010b )
. Crop ty pe also may

play an important ro le in the ty pe of soil microorganisms in soils ( Larkin, 2003 )
. Plant roots, including those of potato , release a variet y of compounds into the soil creating a unique environment for microorganisms in the rhizosphere , whereb y microorganisms may be attracted to and stimulated by the roots ( Inceoglu et al. , 2013 )
. Microbial diversity in the rhizosphere may

be extensive and differs from the microbial community in the bulk soil ( Garbeva et al. , 2004a)
. Larkin ( Larkin and Honeycutt, 2006 ) investigated th e effect of potato production on soil microbial communities over a period of three ye ars. A two
- ye ar rotation period appears to control soilborne 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 severit y of black scurf, as well as reduced the number of misshapen tubers. Larkin ( Larkin and Honeycutt, 2006 ) suggested that activity and diversity

of microbial populations were negativel y correlated with the perce ntage 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 positive effects on bacterial numbers in the soil, diversi ty 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 cont ent, as well as specific fertilizers ( Inceoglu et al. , 2013 )
.29

Pathogenic microorganisms which are associated with diseases of potatoes , is discussed in section 2.2.7 , General Agronomic Practices , Disease Control
.30

2.1.1 2.2.5 Biodiversity Biodiversity

refers to all plants, animals, and microorgani sms interacting in an ecos ys tem . Biodiversity

provides valuable genetic resources for crop improvement ( Wilson, 1988a ; Wilson, 1988b ) ; ( Harlan, 1975b ; Harlan, 1975a ) , and also provides other functions beyond food, fiber, fuel, and income. These include pollination, genetic introgression, biological control, nutrient recycling, competition against natural enemies, soil structure, soil and water conservation, disease suppression, control of local microclimate, control of local h ydrological 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 agroecosy stem depends on four primary characteristics: 1) diversity of vegetation within and around the agroecos ys tem; 2) permanence of various crops within the sy stem; 3) intensity of management; 4) extent of isolation of the agroecos y stem from natural vegetation ( Southwood and Way , 1970 )
. Agricultural land subject to intensive farming practices, such as that used in crop production, generall y has low levels of biodiversity compared with adjacent natural areas ( Altieri, 1999 )
. Tillage, seed bed preparation, planting of a monoculture crop, pesticide use, fertilizer use, and harvest ing limits the diversity of plants and animals ( Lo vett et al. , 2003 )
. Biodiv ersity

can be maintained or reintroduced into agroecos ys tems 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 (growing a crop specifically for the purpose of incorp orating it into the soil in order to provide nutrients and organic matter), addition of organic matter ( e.g., compost, green manure, animal manure), hedgerows and windbreaks ( Altieri, 1999 )
. Because potatoes are grown throughout regi ons 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 in Section 2.2 , Agronomic Practices, Weed Control, and animals in Section 2.4.2, Animal Communities. **2.2** 2.2.1 2.2.6 Human Health Humans interact with potatoes either as consumers of potato and products derived from it, as wor kers who produce potato crops . Under the FFDCA, it is the responsibility of food and feed manufacturers to ensure that 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. GE organisms 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 commer cialize a bioengineered food meets with the agency to identify

and discuss relevant safet y, nutritional, or other regulatory issues regarding the bioengineered food and then submits to FDA a summary

of its scientific and regulatory assessment of the food ( insert reference to31

FDA letter). FDA evaluates the submission and responds to the developer by letter. Simplot submitted a letter of consultation on February 12, 2013 , which FDA is still reviewing ( BNF No. 141)
. As noted by

the National Research Counci l (NRC), unexpected and unintended compositional changes arise with all forms of genetic modification, including both conventional hy bridizing and genetic engineering (NRC, 2004 ) . The NRC also noted that at the time, no adverse health effects attribut ed to genetic engineering had been documented in the human population. Reviews on the nutritional quality of GE foods have generally concluded that there are no significant nutritional differences in conventional versus GE plants for food or animal feed ( Faust, 2002 ; Flachowsky et al. , 2005 )
. Consumer Health The potato is the world’s number one non
- gra in 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 ( Arvanito yannis et al. , 2008 ) ( Bushway , 2010 ) ( FAO, 2008 )
. T hey have the highest protein content (around 2.1 percent 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 ( Bushway , 2010 )
. Because of their high sugar and starch content and resulting high gl ycemic index, consumption of potatoes by

persons with diabetes or similar conditions may need to eat potatoes sparingly
. U.S. per capita potato consumption is summarized in Table 6 (NPC, 20 12b )
. **Table 6**  **. U .S. Per Capita Potato**  **Consumption in**  **2012**

Fresh Market Processing All Potatoes Canned Frozen Chips Deh ydrated Total Processing 35 1 50 15 12 78 112 Source: (NPC, 2012b ) ; totals may not add due to rounding. Toxins and Allergens in Potato Potatoes contain two classes of toxins and/or allergens: gl yco alkal o ids and patatins. Acrylamide is a toxic compound formed in cooking potatoes at high temperatures, such as roasting or baking and frying. Glycoalkaloids are well
- known naturall y - occurring compounds that are present in all potatoes , which likely serve a defense me chanism against predator attack
. These compounds are concentrated in foliage, flowers and sprouts, although gl yco alkaloids are present in lower concentrations in other parts of the plant, including tubers. For food safety purposes, an upper limit for glyc oalkaloid content of 20 m illigrams per 100 grams of potato is generall y accepted.32

Concentrations exceeding this are potentially poisonous to humans and livestock
. Li ght exposure to harvested tubers can increase gl yco alkaloid content in potatoes, and may r esult in green areas of coloration on potato skins ( Sinden, 1987a) ( Center, 2010 )
. Patatin s are a family of protein s that makes up 30 to 40 percent of the soluble protein in potatoes ( Mignery et al. , 1988 ) . Allergic reactions to cooked potatoes are considered to be very uncommon and have b een reported for children only ( De Swert et al. , 2002 ) , with patatin identified as the major alle rgen involved in this reac tion ( De Swert et al. , 2007 )
. Because potato protein naturall y contains a relativel y large proportion of patatin, those who are allergic to p atatin woul d nee d to avoid eating potatoes
. Of greatest significance to human health is the toxic compound acrylamide, which is a known carcinogen of rodents and a probable human car cinogen ( WHO
- IARC, 1994 ) (NTP, 2011 ) ( Chawla et al. , 2012 ) ( Halford 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 mamma lian 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 cooke d at high temperatures, such as baking or frying. In 2002, Swedish researchers demonstrated that acrylamide forms when starchy foods, such as potatoes and breads, are heated at high temperatures, such as in baking, roasting, and frying, 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 f rom plants. Acrylamide forms during the Maillard reaction ( Martins et al. , 2000 ) wh ich is a reaction at high temperatures (such as frying French fries) between certain sugars such as glucose and fructose (reducing sugars) and asparagine (an amino acid) that are naturally present in the food ( FDA, 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 )
. O xidation of the free amino acid asparagine, a major amino acid in potatoes and cereals ( Mottram et al. , 2002 ; Chawla et al. , 2012 ) , is the main source of acryl amide when st arch y 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, the higher the greater the acrylamide concentration ( Halford et al. , 2012a) ( Kotsiou et al. , 2013 ) ( Pedreschi, 2009 ) ( Arvanitoyannis et al. , 2008 )
. Important variables leading to acrylamide formation and affecting acrylamide concentration in cooked potatoes include reducing sugar content, processing/cooking temperature and method, cooking/processing time, moisture content, and additives ( Kotsiou et al. , 2013 ) ( Halford et al. , 2012a) . In turn, concentrations of sugars and amino acids are influenced by cultivar, fertilizers, climate, and storage conditions ( Pedreschi, 2009 )
.33

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 ) . Acrylamide is also present in other foods such as coffee, some breads, biscuits, gingerbread, and processed onion mix and dip mixes. Smoking may contribute to human exposure to acrylamide ( Chawla et al. , 2012 ) ( Kotsiou et al. , 2013 ) ( Friedman, 2003 )
. 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 FAO/WHO Expert Committee on Food Additives has recommended that dietary exposure to acryl amide should be reduced ( FAO/WHO, 2011 )
. Perhaps because children consume more acryl amide
- 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 acryl amide as a potential carcinogen under Proposition 65 in 1990 and established a No Significant Risk Level (NSRL ) of 0.2 μ g/ day ( CEPA
- OEHHA, 2005 ) . Subsequent to the discovery of acrylamide in cooked foods, this NSRLwas 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, 2013a)
. Proposition 65 requires that food manufacturers warn consumers about the dangers of acrylamide in their products. In 2005, the State of Californ ia sued Frito
- La y, Kettle Foods and Lance, Inc. for failing to provide such warnings. In the settlement, the potato chip manufacturers agreed to reduce the acrylamide in their products to 275 ppb, low enough to avoid the Proposition 65 warning. These thr ee companies also agreed to pay close to $2M in penalties and court costs. The potato processing industry now has a strong financial incentive to reduce the levels of acryl amide in their retail products. Worker Health Worker hazards in farming are commo n to all t yp es 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 safet y risk , unless used in accordance with the US
- EPA
- established agriculture
- specific requirements in the Worker Protection Standard (WPS) (40 CFR Part 170) that protect workers fro m the hazards of chemical exposure. The WPS offers protections to more than two and a half million agricultural workers who work with pesticides at more than 560,000 workplaces on farms, forests, nurseries, and greenhouses. The WPS contains requirements fo r pesticide safet y 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 H ealth Administration requires all employers to protect their emplo ye es 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. A potato field is a highl y managed environment which incorporates the use of agricultural chemicals, including herbicides and insecticides. Pesticides are used on most potato acreage in34

the U
. S
. , and changes in acreage, crop s, or farming practices can affect the amounts and ty pes of pesticides used and thus the risks to workers. Worker safety precautions and use restrictions are noted clearl y on pesticide registration labels. Growers are required 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 include instructions on personal protective equipment, specific handling requirements, and field reentry procedures ( s ee, e.g. ( Carroll and Robinson, 2006 ) ( Carroll and Robinson, 2006 )
. 2.2.7 Animal Feed Potatoes used as livestock feed accounted for approximately 1.2 percent of all potatoes produced in the U.S. in 2012 (see Table 7 ) . This quantit y includes potatoes sold specificall y 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
- NASS, 2013 )
. Use of potatoes for livestock feed is generally dependent on qualit y 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, 2010c )
. **Table 7**  **. U.S. 2012 Potato Utilization** 

**Utilization Item CWT (1,000)**  **(%) Sales** 

**– fresh and processing**  Table stock (fresh) 118,535 (25.6%) Processing Chips and shoestrings 56,349 (12.2%) Deh ydrated (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 282,220 (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%)35 **Utilization Item CWT (1,000)**  **(%) Total Production**  **462,766** Source: (USDA - NASS, 2013 ) Potatoes constitute at least part of the diet for several domestic animals, including cattle, horses, pigs, and poultry . The recommended rate of feed i s approximately 25
- 40 lb potatoes/1,000 lb live weight, but can vary

with the ty

pe of animal. Potatoes 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 of grain ( Corbett, No Date )
. Feed does not includ e the leafy green f oliage of potato plants since flowers, sprouts, and foliage has abundant gl ycoalkaloids, which are potentiall y poisonous for livestock ( Sinden, 1987a)
. Similar to the regulatory

control for direct human consumption of potato under the FFDCA, it is the responsibility

of feed m anufacturers to ensure that the products they market are safe and properl y labeled. Feed derived from GE potato must comply with all applicable legal and regulatory

requirements, which in turn protects human health. To help ensure compliance, GE organism s used for feed may undergo a voluntary consultation process with FDA before release onto the market, which provides the applicant with any needed direction regarding the need for additional data or analy sis, and allows for interagency discussions regardin g possible issues. 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 commercia lize 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 February 12, 2013, whi ch FDA is currently reviewing (BNF No. 141)
. **2.3 Socioeconomics** As part of an evaluation of impacts on the human environment , 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 b y themselves to require preparation o f 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 employ ment, crop production exp enses, crop value and trade . T he main focus of this assessment is the socioeconomic effect on the crop industry , including production and domestic and international trade, and crop producers.36

2.3.1 Domestic Economic Environment Potatoes contribute approximately 15 percent of farm sales receipts for vegetables, making potatoes the leading vegetable crop in the United States ( USDA
- ERS, 2012b ) . The total va lue of U.S. potato production in 2012 was $3.9 billion, the average yi eld was 409 CWT/acre and the average price received was $7.26/CWT ( USDA
- NASS, 2012c ) . Unlike true commodity crops such as corn and so ybeans, most potatoes are grown for a specific market. As shown in Table A, the Russet Burbank and Ranger Russet are primarily used for fries, an d the Atlantic, “H”, and “G” varieties are primarily used for chips. Atlantic is the standard for making potato chips from the field or from very

short storage ( PAA, 2009b ) . Any of these varieties can also be sold on the fresh market. On the fresh market, Russet Burbank and Ranger Russet potatoes are th e standard for baking ( PAA, 2009a) ; ( Pavek et al. , 1992 ) . Other varieties are used for canning and are well
suited for boiling. There are tho usands of potato varieties, some intended for very small markets ( FAO, 20 08 )
. Uses for all potato varieties combined in the United States are summarized in Table 8 . Specific varieties are not grown for the deh ydration market or for livestock feed; rather, food
- grade potatoes considered unsuitable for their intended fresh or other processing markets are usuall y used for these purposes ( Guenther, 2010c ) . Because potato sales for livestock feed usually receive the lowest price, potat oes are not sold for livestock feed if other uses are available ( Guenther, 2010c )
. **Table 8**  **. A Sample of U.S. Potato Varieties and**  **their Uses**

**Variety 1**  **Use** Russet Burbank Boiling, baking, chipping, French frying Ranger Russet Baking, French frying Atlantic Fresh market, chipping Kennebec Boiling, pan frying, chipping, French frying Norland Boiling, French frying, chipping Yukon Gold Fresh market, boiling, baking, French frying 1 http://potatoes.wsu.edu/varieties/vars
- all.htm Fresh market potatoes in North America can be classified broadl y as russets, 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. Recently , western growers have entered the packing business, often in partnerships or cooperatives wi th other growers ( Guenther, 2010a)
. Fresh potatoes may

be shipped in refrigerated rail cars or trucks to maintain a high standard of quality whereas frozen and dehydration processing t ypicall y occurs near potato producti on areas. The fragilit y of chips and the high cost of shipping low
- density products results in most chipping plants being located near populated areas. Except for deh ydrators, processors ty pically 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, processing37

the rest. Others purchase off
- grade potatoes from fresh packers for processing ( Guenther, 2010b )
. Revenues and costs of potato production vary widely , depending on geography , growing conditions, the local economy , the t ype of potato, farm size, and other factors. For example, the 2011 per acre operating cost of growin g Russet Burbank potatoes in Southwestern 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 variet y was grown in South
- Central Idaho, the 2011 per acre operating cost, including on
- farm storage and fumigation, was $2,56 0 ( Patterson, 2011 ) , and the gross return per acre averaged $3681.25, resulting in a net return of $1,121. Approximately

90 percent o f U.S. potatoes are planted in the spring and harvested in the fall, and western states 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 ye ar. Less than 10 percent of potatoes are harvested in winter, spring and summer; however, these potatoes meet specific market needs (e.g., new potatoes) and tend to yi eld higher prices than fall potatoes ( USDA
- ERS, 2012b )
. Sales value per acre is normally highest for the winter crop and lowest for fall potatoes, but varies widel y among the producing states. Prices for fresh potatoes are usually highe r than prices for processing potatoes due to crop
- quality standards. Domestic potato prices may vary not only in response to changes in weather, yi eld 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, greening, sprouting and disease. Crops that suffer frost damage also are added to this category ( Guenther, 2010c )
. Potato production requires numerous expenditures, including for specialized machinery . The largest conventional operating cost items are fertilizer, chemicals and pesticides, storage and seed potatoes. Fertilizer and seed accounted for 25 percent of tota l production costs in eastern Id aho in 2007 ( Patterson, 2010 ) . Potato production costs for irrigation in the western United States ranges between $ 1,500 and $3,500 per acre ( Patterson, 2010 ) . Costs do not stop accumulating at harvest unless the potatoes are sold out of the field. Additional c osts are incurred to store potatoes. For those producing organic potatoes, an organic production sy stem is required in addition to a relativel y long crop rotation to minimize pest problems. Profitability margins differ between organic farm sizes, but a study conducted in southern Idaho indic ated that net returns over variable costs for a small farm (30
- 50 acres) with 100% organic premiums is $1,026/acre and38

$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 th e hours on a large organic farm. While larger farms reduce labor expenses b y 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 suppl y so ils with additional 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 )
. One of the traits of Simplot InnateTM Potato , reduced black spot bruising, is of major significance to economic markets. In general, post
- harvest loss es are a significant part of the production costs of fruits and vegetables, and may reach as high as 50% ( Ll orente et al. , 2011 ) ( Martinez and Whitaker, 1995 ) . Browning of fruits and vegetables negatively affects consumer acceptance because of altered appearance and perceived nutritio nal deficit ( Llorente et al. , 2011 )
. Specificall y, potato growers can lose up to 20% of income through potato injury at harvest ( Preston, 2010 ) . The potato industry , therefore, has a vested interest in minimizing these losses. Black spot bruise is t ypically caused b y 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 s ymptoms 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 a l. , 2010 ) ( Urbany et al. , 2011 )
. Because bruising cannot be observed until the potato skin is removed, it is more difficult to identify

damaged tubers, and makes conventional means of breeding to eliminate this trait more problematic ( Urban y et al. , 2011 )
. Phy sical 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 ex ample, if potato tissue does not crack during injury , the force of the impact is more evenl y distributed throughout a larger area of the tuber, which results in greater changes to metabolism, and, hence more bruising ( Stremmel et al. , 2010 )
. Therefore, bruising susceptibility varies widely among potato cultivars ( Stremmel et a l. , 2010 ) . To a large extent, susceptibility is dependent on multiple genetic traits, as well as on maturity of tubers and environmental factors ( Urban y et al. , 2011 )
. P otato genot ypes 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 enzy me poly phenol oxidase (PPO) ( Di rks
- Hofmeister et al. , 2013 ) . These quinoids auto
- oxidize, forming melanin, leading to blackened tissue which is called enz ym atic browning and is undesirable in processed potato product ( Hunt et al. , 1993 ; Ll orente et al. , 2011 ) ( Steffens, 1994 ) ( Stremmel et al. , 2010 ; Vitti et al. , 2011 )
. Oxidative browning reactions generally ca use 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, 200 3 ) . The side chains of essential amino acids in plant39

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 ( Urban y et al. , 2011 )
. Poly

pheno l oxidase expression is mediated by a multigene family

in potato ( Thygesen et al. , 1995 ) ( Ll orente 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 )
. 2.3.2 Trade Economic Environment U.S. and global trade are greatl y affected b y 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 rat es, government support for agriculture, and trade protection policies. U.S. farmers and agricultural firms rel y heavily on export markets to sustain prices and revenues because productivity

of U.S. agriculture increases faster than the demand for domesti c 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 variet y. This also tends to stabilize year
- round suppl ies of and prices for fresh fruits and vegetables. U.S. exports of potatoes and potato products have grown 133 percent in value and 79 percent in volume during the last 10 marketing ye ars ( Board, 2013 ) . Frozen potato products comprise 60 percent of the U.S. potato exports. During the 2012/ 2013 market year (September
- August), U.S exports of potatoes and potato products totaled $1.6 billion

— up from $1.4 billion in the previous market year ( USDA
- ERS, 2013 ) . Exports to target markets were led b y an increase in shipme nts to Mexico, South Korea, Malay sia, and Vietnam. During the 2012/ 2013 market y ear, Canada was the largest market for chips while Japan was the largest market for frozen potato products and dried, flour, and meal potato products ( USDA
- ERS, 2013 ) ; ( Board, 2012 ) . M exico provides the United States with the largest market for exporting potato flakes and granules and is the second largest market destination for frozen potatoes ( USDA
- ERS, 2013 ) ; ( Board, 2012 )
. U.S. potato and potato product exports are expected to grow during the upcoming marketing ye ar ( Board, 2013 ) . Growth rates will depend upon economic growth in the markets and the suppl y and price of competitor products. The United States will facilitate the growth of the export market b y continuing to gain new market access, as just occurred for fresh table
- stock to the Philippines ( Board, 2013 )
. 2.3.3 Organically Certified Economic Environment In the U.S., only

products produced using 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 certificatio n process specifies and audits the methods and procedures b y which the product is produced.40

In accordance with NOP, each ye ar an accredited organic certifying agent must review an operation. This must include a review of its organic sy stem 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 with USDA organic standards. Section 205.105 of the regulations identifies “ Al lowed 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’ (specified ingredients or food group(s)),” the product must be produced and handled without the use of: . . . (e) Excluded methods . . . .” 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 macroencapsulation, 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, conjugation, fermentation, hybridization, in vitro fertilization, or tissue culture.” Organic farming operations, as described b y the NOP, are required to have distinct, defin ed boundaries and buffer zones to prevent unintended contact with excluded methods from adjoining land that is not under organic management. Organic production operations must also develop and maintain an organic production sy stem plan approved b y their a ccredited 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 ude planting onl y 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 exclud ed 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 necessaril y 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 detailed in their approved organic s ys t em plan ( Ronald and Fouche, 2006 ; USDA
AMS, 2010 )
. Organic market and products41

The organic sector is rapidly growing both in the United States 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 inc reased 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 ) . Organi c products represented approximately

4 % of total 2010 sales in the food and beverage sector ( Organic Trade Association, 2011 )
. Organic Potatoes In 20 08 , 2.2 million CWT of organic potat oes were harvested, with a total sales value of almost $29 million ($13. 24 /CWT) ( USDA
- NASS, 2012a)
. Prices for organic potatoes are t y pically substantially

higher than the overall average conventional potato price, and probably reflects both the organic premium and the fact that most organic potatoes are sold fresh. Organic growers ty

pically receive a significant price premium when they can sell their potatoes as organic ( Dufour et al. , 2009 ) ; however, that market is not al way s 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 ) **3. ALTERNATIVES**  This document anal yz es the potential environmental consequences of a determination of nonregulated status of Simplot InnateTM Potato . To respond favorabl y to a petition for nonregulated status, APHI S must determine that Simplot InnateTM Potato is unlikely to pose a plant pest risk. Based on its PPRA ( USDA
- APHIS, 2013a) , APHIS has concluded that Simplot InnateTM Potato is unlikely to pose a plant pest risk. Therefore APHI S must det ermine that Simplot InnateTM Potato is no longer subject to 7 CFR part 340 or the plant pest provisions of the Plant Protection Act
. Two alternatives are evaluated in this EA: (1) no action and (2) determination of nonregulated status of event. APHIS has a ssessed 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 Potato and progen y derived from Simplot Innate TM Potato 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 Pot ato and measures to ensure ph ys ical and reproductive confinement would continue to be implemented. APHI S might choose this alternative if there were insufficient evidence to demonstrate the lack of plant pest risk from the unconfined cultivation of Simplo t Inn ate TM Potato
.42

This alternative is not the Preferred Alternative because APHIS has concluded through a Plant Pest Risk Assessment that Simplot Innate TM Potato is unlikely to pose a plant pest risk ( USDA
APHI S, 2 013a ) . 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**  **Potato I**  **s No Longer a Regulated Article**  Under this alternative, Simplot Innate TM Potato and progen y derived from them would no longer be regulated articles under the regulations at 7 CFR part 340. Simplot Innate TM Potato is unlikely to pose a plant pest risk ( USDA
- APHIS, 2013a) . Permits issued or notifications acknowledged b y APHIS would no longer be required for introductions of Simplot Innate TM Potato and progen y derived from this event. This alternative best meet s the purpose and need to respond appropriatel y to a petition for nonregulated status based on the requirements in 7 CFR part 340 and the agency ’s authority under the plant pest provisions of the Plant Protection Act. Because the agency

has concluded that Simplot Innate TM Potato is unlikely to pose a plant pest risk, a determination of nonregulated status of Simplot Innate TM Potato is a response that is consistent with the plant pest provisions of the PPA, the regulations codified in 7 CFR part 340, and the b iotechnology

regulatory

policies in the Coordinated Framework. Under this alternative, growers may have future access to Simplot Innate TM Potato and progen y derived from this event if the developer decides to commercialize Simplot Innate TM Potato
. **3.3 Alter natives**  **Considered But Rejected from Further Consideratio n**  APHI S assembled a list of alternatives that might be considered for Simplot Innate TM Potato
. The agency

evaluated these alternatives, in light of the agency 's authority under the plant pest provisions of the Plant Protection Act, and the regulations at 7 CFR part 340, with respect to environmental safety , efficacy , and practicality to identify which alternatives would be further considered for Simplot Innate TM Potato . Based on this evaluation, APHI S rejected several alternatives. These alternatives are discussed briefly below along with the specific reasons for rejecting each. 3 .3.1 Prohibit Any Simplot InnateTM Potato from Being Released In response to public comments that stated a preference that no GE organisms enter the marketplace, APHIS considered prohibiting the release of Simplot Innate TM Potato , including denying any

permits associated wi th the field testing. APHIS determined that this alternative is not appropriate given that APHI S has concluded that Simplot Innate TM Potato is unlikely to pose a plant pest risk ( USDA
- APHI S, 2013a )
. In enacting the PPA , Congress included findings in Section 402(4) that : “d ecisions affecting imports, exports, and interstate movement of products regulated under this title [i.e., the PPA] shall be b ased on sound science;” On March 11, 2011, in a Memorandum for the Heads of Executive Departments and Agencies, the White House Emerging Technologies Interagency Policy Coordination Committee43

established principles consistent with Executive Order 13563 to guide agencies in th e de velopment and implementation of policies for oversight of emerging technologies such as GE that included the following guidance: “D ecisions should be based on the best reasonabl y obtainable scientific, technical, economic, and other information, within the boundaries of the authorities and mandates of each agency ; . . . ” Consistent with this guidance and b ased on the findings and scientific data evaluated for the PPRA ( USDA
- APHI S, 2013a) , APHIS concluded that S implot Innate TM Potato is unlikely to pose a plant pest risk. Therefore, there is no basis in science for prohibiting the release of Simplot Innate TM Potato. 3.3.2 Approve the P etition in P art The regulations at 7 CFR 340.6(d) ( 3 ) ( i) state that APHI S 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 Innate TM Potato is unlikely to pose a plant pest risk, there is no regulatory

basis under the plant pest provisions of the Plant Protection Act for considering approval of the petition only in part. 3.3.3 Isolation Distance be tween Simplot Innate TM Potato and Non
- GE Potato Production and Geographical Restrictions In response to public concerns of gene movement between GE and non
- GE plants, APHI S considered requiring an isolation distance separating Simplot Innate TM Potato from co nventional or specialt y potato production. However, because APHI S has concluded that Simplot InnateTM Potato is unlikely

to pose a plant pest risk ( USDA
- APHI S, 2013a ) , an alternative based on requiring isolation distances would be inconsistent with the statutory authority under the plant pest provisions of the Plant Protection Act and regulations in 7 CFR part 340. APHI S also considered geographically restricting the production of Simplot Innate TM Potato based on the location of production of non
- GE potato in organic production sy stems or production sy stems for GE
- sensitive markets in response to public concerns regarding possible gene movement between GE and non
- GE plants. However, as presented in APHI S’ plant pest risk assessment for Simplot Innate TM Potato , there are no geographic differences associated with any identifiable plant pest risks for Simplot InnateTM Potato ( USDA
- APH IS, 2013a) . This alternative was rejected and not analyzed in detail because APHI S has concluded that Simplot Innate TM Potato does not pose a plant pest risk, and will not exhibit a greater plant pest risk in any geographicall y restricted area. Therefo re, such an alternative would not be consistent with APHI S’ statutory

authority under the plant pest provisions of the Plant Protection Act and regulations in Part 340 and the biotechnology regulatory

policies embodied in the Coordinated Framework. Based o n the foregoing, the imposition of isolation distances or geographic restrictions would not meet APHI S’ 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 authorit y under the plant pest44

provisions of the Plant Protection Act. However, individuals might choose on their own to geographically

isolate their non
- GE potato production sy stems from potato or to use isolation distances and other management practices to minimiz e gene movement between potato fields. In formation to assist growers in making informed management decisions for Simplot Innate TM Potato is available from Association of Official Seed Certifying Agencies ( AOSCA, 2010 )
. 3.3.4 Requirement of Testing for Simplot InnateTM 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 sy stems. APHI S notes there are no nationally
- established regulations involvi ng testing, criteria, or limits of GE material in non
- GE sy stems. Such a requirement would be extremely difficult to implement and maintain. Additionally , because Simplot Innate TM Potato does not pose a plant pest risk ( USDA
- APHIS, 2013a) , the imposition of any ty pe of testing requirements is inconsistent with the plant pest provisions of the Plant Protection Act, the regulations at 7 CFR part 340 and biotechnology regulatory

policies embodied in the Coordinated Framework. Therefore, imposing such a requirement for Simplot Innate TM Potato would not meet APHI S’ purpose and need to respond appropriatel y to the petition in accordance with its regulatory authorities. 3.4 Comparison of Alternatives Table 9 includes a summary of the potential impacts associated with selection of either of the alternatives evaluated in this EA . The impact assessment is presented in Section 4 of this EA
.45

**Table 9**  **. Summary of Issues of P**  **otential Im**  **pacts 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, 2013a ) **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 continue 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 Potato may reduce acreage dedicated to conventional potatoes. Agronomic Practices Agronomic practices will remain the same as used currently. Unchanged from No Action Alternative
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 ative 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
**Env ironment** 46

**Table 9**  **. Summary of Issues of P**  **otential Im**  **pacts and Consequences of**  **A lternatives**  **Attribute/Measure Alternative A: No Action**  **Alternative B: Determination of**  **Nonregulated Status**

Water Resources T he p rim ar y c ause of a gr i c ultu ral non
-point source pollution is in crea s e d s e dim e nt ation fr om soil er osion, whi c h can int

r odu c e s e di m e nts, fertili z er s, a

nd p e sti c id e s to n ear b y l ake s and st

r e ams. A gr o nomic p rac ti ce s s u c h a s c r op nut r i e nt m an a g e m e nt, p e st m an a g e m e nt, and c o ns erv ation bu ffer s h e lp p r ot ec t w at e r qu ali ty fr om a gr i c ultur al r uno f f. Water usage for irrigation would be expected to continue to increase. Unchanged from No Action Alternative

Soil Quality A gr onomic p r a c ti ce s su c h a s cr op ty p e , till a g e , and p e st m an a g e m e nt can a f

f e c t soil qu ali ty . Gr o wer s will a dopt m an 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 Agr i cu l tu ral ac tiv it i e s suc h as bu r n ing, tilling , ha

r ve sting , spra y ing p e sti ci de s , a

nd fer t i lizing , includ

ing the emi s si ons f rom f a r m e qu ipmen t , c a n d ir ectly af fect a ir q ualit y. Aer i a l a pp li ca tion o f herbicides ma

y im p act a ir q ua lit y f rom d r i f t , d i f f u si o n , a nd vol a t i liza t i on o f t he c hem i c a l s , as well as motor vehi cl e e m i ss i ons f r om a ir p l a ne s or heli c opters. Unchanged from No Action Alternative

Climate Change A gr i c ultu re - re l at e d ac tiviti e s ar e rec o gni z e d a s both di r e c t sou rce s of gr ee nhouse g a s e s ( GHG s ) (e
. g ., e x h aust from moto r i z e d e quipm e nt) and indi rec t sou

r c e s (e
. g ., a gr i c ultu re - r e l at e d soil distu r b a n ce , f ertili z e r p r o du c tion. Unchanged from No Action Alternative47

**Table 9**  **. Summary of Issues of P**  **otential Im**  **pacts and Consequences of**  **A lternatives**  **Attribute/Measure Alternative A: No Action**  **Alternative B: Determination of**  **Nonregulated Status**
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 Sim plot InnateTM tubers may be exposed to increas ed levels of glutamine, but this is not expected to be detrimental.

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 gr o wer s use p rodu c tion p rac ti ce s to m an a g e w e e ds in and ar ound potato fields. In the un likely event of hybridization of Simplot InnateTM Potato with conventional varieties, resulting progeny may contain lowered polyphenol oxidase levels. However, this is not expected to be detrimental. Simplot InnateTM Potato is no weedier than conventional p otatoes.

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 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**48

**Table 9**  **. Summary of Issues of P**  **otential Im**  **pacts and Consequences of**  **A lternatives**  **Attribute/Measure Alternative A: No Action**  **Alternative B: Determination of**  **Nonregulated Status**

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 would be reduced approximately 6 0
- 70%, which will benefit human health. 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) and potential reduced wastage (low bruising), Simplot InnateTM Potato 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 in 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 Simplo t InnateTM potatoes are anticipated to be similar to the No Action Alternative. However, import of each specific trait requires separate application and approval by the importing country. If the Simplot InnateTM traits are approved by importing countries, i t may make up a larger percentage of potato import markets. **Other Regulatory Approvals** U.S. FDA FDA is currently reviewing Simplot’s voluntary consultation submission of February 12, 2013.49

**Table 9**  **. Summary of Issues of P**  **otential Im**  **pacts 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 Potato. **Compliance with Other Laws** CWA, CAA, EO s Fully compliant Fully compliant50

**4 ENVIRONMENTAL CONSEQ**  **UENCES 4.1 Environmental**  **Consequences** This analy sis of potential environmental consequences addresses the potential impact to the human environment from the alternatives anal yz ed in this EA, namely taking no action and a determination by

the agency

that Simplot Innate TM Potato doe s not pose a plant pest risk. Potential environmental impacts from the No Action Alternative and the Preferred Alternative for Simplot Innate TM Potato are described in detail throughout this section. A cumulative effects anal ys is is presented for potential ly 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 Alternativ e and the Preferred Alternative for Simplot Innate TM Potato 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 each resourc e area in Section 2.0). 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 b y an intermediate step or process. Examples include surface water quality changes resulting from soil erosion due to increased tillage, and worker safe ty impacts resulting from an increase in herbicide use. A cumulative effects analy sis 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 foreseeable future actions. Examples include breeding Simplot Innate TM Potato 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 discussed 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. Although the preferred alternative would allow for new plantings of Simplot InnateTM Potato to oc cur anywhere in the U.S., APHIS will limit the environmental analysis to those areas that currently support potato production. **4.3 Agricultural Production of**  **Potato** 4.3 .1 Acreage and Area of Potato Production Acreage of potato production has decreased i n recent years, whereas potato yi elds have increased dr amaticall y . Potato acres harvested in the U.S. have ranged between 1.0 and 1.5 million acres51

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 2012). Per
- acre yi elds, which averaged 397 CWT per acre in 2011 and 401 CWT per acre in 2012 have increased eight
- fold since the early 1900s and have doubled since the earl y 1960s ( USDA
- NASS, 2013 )
. No Action Alternative: Acreage and Area of Potato Production USDA projects potato production will increase b y 4.6% between 2012 and 2021 ( USDA, 2012 )
. Based upon historical trends in pro ductivity , this increase in supply is unlikely

to result in an increase in potato acreage. Therefore, under the No Action alternative , agricultural land used for potato production is expected to remain at approximately the same a s at present. Preferred A lternative: Acreage and Area of Potato Production If APHIS chooses th e P referred A lternative, some of the Simplot InnateTM Potato events may become commerciall y available to the general public. Growers who now purchase conventional varieties of Russet Burbank, Ranger Russet and Atlantic potato seed would have the option of purchasing the Simplot InnateTM varieties instead of their conventional counterparts. With the reduction in black spot bruising and lower levels of reducing sugars, the Ranger Russet may gain more market share, partially replacing the Russet Burbank. The lower levels of reducing sugars in the Atlantic potato may result in in creased market share for that variety , as well. However, the introduction of these varieties is not expected to have an impact on overall demand for potatoes. As described in the petition ( Simplot, 2013a) , the agronomic characteristics of the ten Simplot Innate events are essentially the same as their conventional counterparts, and therefore would be grown in the same way as their conventional counterparts. The ten Simplot Innate TM Potato events do 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 potato would remain about the same. Simplot’s data demonstrate no differences in morphological characteristics and agronomic requirements between Simplot InnateTM Potato and other potato cultivars ( Simplot, 2013 a) and is not likely to change land acreage or any cultivation practices for potato production. It is expected that similar agronomic practices commonl y utilized in commerciall y available potato cultivars would also be used b y growers of Simplot Innate TM Potato
. 4.2.2 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. Preferred Alternative: Agronomic Practices52

T he agronomic evaluation of the ten Simplot Innate TM Potato events is summarized in Section 7 of the petition, with details provided in Appendix 6; analysis of disease susceptibility is presented in petition Appendix 8 ( Simplot, 2013a) . Since all ten Simplot Innate TM Potato events are intended for fry

and chip production, agronomic evaluations were conducted in geographical ly

distinct sites that represent most of the main product ion areas for potatoes destined for fry

and chip production in the U
. S
. ( Simplot, 2013a) . The a gronomic practices and pest control measures employed were location
- specific an d t ypical for potato cultivation. They were recommended by

both regional potato extension specialists and field agronomists including soil preparation, fertilizer application, irrigation, cultivation and pesticide
- based control methods. Events and untransf

ormed varieties received identical inputs and treatments at each site. The following characteristics were evaluated over multi
- ye ar trials: time to emergence, vigor, leaf size, leaf curl, vine maturity , disease susceptibility, insect damage, yi eld and spe cific gravity
. These trials indicated that no changes to current agronomic practices will be needed to grow the potatoes , thus the incorporated traits are not expected to affect agronomic practices. All events considered for deregulation were selected to exhibit comparable phenot ypic characteristics to the control varieties when grown using standard industry practice s . There were no differences in disease susceptibility

that would require additional treatments , nor did the potatoes have different nutrient requirements that would alter fertilizer programs. Planting, cultivation, management and harvesting processes were not affected b y the incorporated traits. APHI S could not identify any significant changes to agricultural or cultivation practices (e.g. pesticide applications, tillage, irrigation, harvesting, etc.) that would result from adoption of the GE crop; therefore, no impact on plant diseases or pests or thei r management is likely to occur ( USDA
- APHIS, 2013 a )
. Based on these analy ses, i f APHI S chooses the preferred Alternative, there would be no expected differences in general production practices than if the No Action alternative is chosen. 4.2.3 Potato Seed Production No Act i on Alternative: Potato See d Production If APHIS chooses the No Action Alternative, potato seed production is expected to continue as it is currentl y. Preferred Alternative: Potato Seed Production Since APHI S has determined that agronomic practices will be the same if the petition is approved ( USDA
- APHIS, 2013a) , selection of the Preferred Alternative is not expected to result in any changes in potato seed production. 4.2.4 Organic Potato Production No Action Alternative: Organi c Potato Production53

In the United States, 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 “organi c” ( 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 th e product is produced. The organic sector is rapidly growing both in the U.S. and the European Union (EU). Together, consumer purchases in these two regions made up 95 percent of estimated world retail sales of organic food products in 2003 ( Dimitri and Oberholtzer, 2005 ) . In 2009, world retail sales of organic products were estimated 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 competition and production costs. Preferred Alternative: Organic Potato Production Practic es Potato cultivar selection and breeding practices are similar between organic and conventional pot ato 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 are the same as those that organic growers already experience when keeping their organicall y grown potatoes separate from potatoes grown with conventional methods. Because potatoes are clonall y propagated, the risk of affecting seed supplies through cross
- pollination is negligible. Organic farmers routinel y plant o rganic 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 not be expected to modify production practices, and so no i mpacts 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, organic potato acreage from 1997 to 2008 showed a general in creasing trend ranging from a low of 4,335 acres in 1997 to a high of 11,664 in 2007 ( USDA
- ERS, 2009 )
. It is important 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 affe ct the status 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 s ys tem plan ( Ronald and Fouche, 2006 ; USDA
- AMS, 2010 ) ( USDA
- AMS, 2010 ) . However, certain markets or contracts may have defined thresholds (Non
- GMO
- Project, 2010 )
.54

**4.3 Physical Environment**  4.3. 1 Water Resources No Action A lternative: Water Resources The majority

of potato production utilizes irrigation as a water source. As discussed in Section 2.3.1, agricultural production can be detrimental to w ater qualit y by adding sediments from erosion via surface water , and nutrient loading from fertilizers into groundwater. If APHIS chooses the No Action alternative , water usage for irrigation would be expected to continue. Supplemental irrigation may increase in som e areas where potatoes have traditionally been grown without 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 potatoes ( Simplot, 2013a)
. Simplot’s studies demonstrate no differences in morphological characteristics and agronomi c requirements between Simplot InnateTM Potato and other potato varieties ( Simplot, 2013a)
. Again, as with the No Action Alternative, supplemental irrigation may

increase in some areas where potatoes have tr aditionally been grown without irrigation, and potential for water quality impacts will continu e . A determination of nonregulated status of Simplot InnateTM potatoes is not expected to change the management practices currentl y employed for potato cultivation. Water quality impacts are expected to be the same under the Preferred Alternative as under the No Action Alternative
. 4.3.2 Soil Quality No Acti on A lternative: Soil Quality In creased 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 he alth, they 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 biological activity ( USDA
- NRCS, 2001 ) . Methods to improve soil quality include careful management of fertilizers and pesticides; use of cover crops to increase plant diver sity 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 )
. Li ving cover also protects against erosion, provides habitat and substrate for soil organisms, and increases soil organic residue inputs ( Doran et al. , 1996a)
.55

If APHIS chooses the No Action alternative, impacts on soil quality are expected to continue. Preferred A lternative: Soil Quality A determination of nonregulation for Simplot InnateTM Potato is not expected to change the management practices currentl y emplo yed 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. Bruinsma ( Bruinsma et al. , 2003 ) found no differences in soil attributable to a GE potato cultivar (not this trait). S implot’s studies demonstrate that agronomic characteristics and cultivation practices required for Simplot InnateTM Potato production are indistinguishable from practices used to grow other potato varieties ( Simplot, 2013a)
. Except for the incorporated traits, the ten events are 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. 4.3.3 Air Quality No Action A lternative: Air Quality If APHIS chooses the No Action alternative , emissions associated with vehicles, fugitive dust particles and pesticides are expected to continue. Preferred A lternative: Air Quality As discussed in Section 2.3.3Air Quality , e missions 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 roadway s and can be generated b y disturbance of bare s oil through vehicle traffic, harvesting operations or wind. These impacts are highl y variable across potato growing regions and over time, depending on such factors as vehicle t ype, crop type, utilization of pesticides, method of application, soil type an d weather conditions. Simplot’s analy ses presented in its petition ( Simplot, 2013a) demonstrate that no changes to agronomic practices will be required to grow Simplot Innat eTM Potato. As discussed in Section 2.3.3, agronomic practices that could affect air quality , such as soil preparation, cultivation, pesticide application and harvesting, were based on practices appropriate for each s ite, and were the same for the events and the controls. The results indicated that no changes from the site
specific practices used for conventional varieties would be needed for production of the ten events. Therefore, if APHI S chooses the preferred alternative , impacts to air quality resulting from this action are expected to be the same as if the No Action alternative had been chosen.56

4.3.4 Climate Change No Action Alternative : Climate Change If APHIS selects the No Action Alternative, impacts to climate ch ange 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, 2013a) and APHI S PPRA ( USDA
APHI S, 2013a ) , Simplot InnateTM 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 , because the range, area, and agronomic practices of potatoes are unlikely to chang e following a determination of nonregulated status of Simplot InnateTM Potato , the agricultural impacts of potato production on climate change are also unlikely to change under the Preferred Alternative. **4.4 . Biological**  **Resources** 4.4.1 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 at the most likely to be affected b y crop production, including aquatic communities, which may be affected by

sedimentation and turbidity from erosion, or by

pesticide runoff. Preferred Alternative: Animal Communities N o changes in land use are expected if APHI S chooses the preferred a lternative. In addition, the evaluation presented in the petition ( Simplot, 2013a) demonstrat es that changes in agronomic practices, including practices related to pesticide use and erosion mitigation , are not required for production of Simplot InnateTM Potato . In addition, there are a large number of insects that feed on potato leaves and other in sects that feed on those pests. Man y of these insects, including the Colorado potato beetle, potato aphid, European corn borer, potato leafhopper and potato ps yl lid are considered pests. The events have not been modified to exhibit any pesticidal activitie s and do not contain pesticide
- expressing genes. No differences were observed for insects or other animals interacting within the potato ecos ys tem during the field trials , leading to the conclusion that the Simplot InnateTM potatoes would have the same imp act on other organisms as conventional potatoes ( Simplot, 2013a)
. APHI S reviewed Simplot’s data on field trials ( USDA
- APHIS, 2013a) and impacts by insects, and concluded that Simplot InnateTM Potato would suffer no greater insect pressure than57

conventional potatoes ( USDA
- APHI S, 2013a)
. For example, no increase in aphid infestation or damag e was reported in the field observations for all ten Simplot InnateTM P otato events ( Simplot, 2013a) . Similarly , although aphids are vectors for viruses such as potato virus Y ( USDA
- APHIS, 2013c ) , no increase in viral disease was reported in field observations for seven of the events ( Simplot, 2013a)
. In addition, since potatoes are propagated vegetatively from seed potato tuber pieces, pollination by bumblebees is not important to potato tuber production. Simplot InnateTM Potato has been geneticall y engineered to silence genes that lead to acryl amide formation and produce PPOs. Acrylamide onl y forms after cooking potatoes at high heat , so this toxic 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 t o 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 ( Kruzm ane et al. , 2002 ) . In other plants, the increase of PPO activity is a direct induced defense against insect pests that decreases nutrient availability ( Baldwin and Preston, 1999 ; Partington et al. , 1999 )
. In addition, PPO in glandular trichomes of wild potatoes (and other plants) is involved in resistance to insects ( Steffens, 1994 ) ( Plaisted, 1980 ) . However, the trichomes of cultivated potatoes contain low amounts of PPO which is not thought to be involv ed resistance to pests ( Friedman, 1997 )
. Phylogenetic survey s of PPO in land plants shows that the gene famil y has undergone evolutionary expansion in some plant families, but is reduced or absent in others, which suggests that PPO function is probably diverse ( Tran et al. , 2012 ) . PPO has also been implicated in other functions such as buffering of plastid oxygen levels , wound healing , and chloropla st metabolism ( Steffens, 1994 )
. In potato, PPO is 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 ) ( Partington et al. , 1999 ) . PPO oxidizes monophenols and o - diphenols to o - quinones, which are then further oxidized non
- enzy

matically to poly phenols. These dark
- pigmented poly phenols, also referred to as melanins, result in the darkening of potato tissue following mechanical bruising ( Th ygesen et al. , 1995 )
. This suggests that Simplot InnateTM Potato is expected to be unchanged relative to PPO gene expression and PPO levels in leaves and therefore unchanged in any potential interaction s betwe en potato foliar PPO and foliar pathogens or pests . No consistent differences were observed in foliar pest and pathogens on Simplot potatoes compared to their control varieties ( Simplot, 2013a) ( USDA
- APHI S, 2013a)
. Simplot did not assess nematode damage of Simplot InnateTM Potato, but Osman et al. ( Osman et al. , 2012 ) suggest that PPO m ight 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 the58

resistance of Simplot InnateTM Potato to some ne matodes. Other researchers found that tubers of potato cultivars resistant to the potato cy st 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 cy sts enables eggs to remain viable in soil for a longer time. Lyo n 1989 ( 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 of Erwinia spp. or P. infestans (the causal agent of late blight), and there remains no proof th at phenols are important in the interaction between potato and Erwinia spp. ( Lyon, 1989 )
. Kroner et al 2012 ( Kroner and Marnet, 2012 ) evaluated the role of specific phenolics in quantitative resistance to the elicitors of two pathogens, P. infestans , the causal agent of late blight, and Pectobacterium atroseptiucm (s ynon ym: E. carotovora subsp. atroseptica ), the causal agent of bacterial soft rot. Increasing concentrations of total phenolics tended toward a positive co rrelation with quantity

of sy mptoms due to the late blight pathogen, but were negativel y correlated with increased tuber rot severity due to the soft rot pathogen. Because chlorogenic acid accumulates in response to soft rot elicitors, these authors sugge st 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 chlorogenic acid in potato tubers
. Although animals would not be exposed to acrylamide, Simplot InnateTM P otato tubers contain increased levels of glutamine ( Simplot, 2013a) because the enzy me asparagine sy

nthetase also functions to de aminate glutamine to glutamate ( USDA
- APHI S, 2013a)
. 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 grown concurrently at the same field sites ( USDA
APHI S, 2013a )
. Souba ( Souba, 1991 ) noted that in mammalian cells, glutamine acts as a nitrogen donor for the biosy nthes is of important compounds such as nucleotides and amino acid
. Consumption of increased glutamine has been tested by some researchers. For example, Wang et al. ( Wang et al. , 2008 ) reported that intestina l dy sfunction and atrophy were prevented when piglets’ diets were supplemented with glutamine. Similarly , Boukhettala et al. ( Boukhettala et al. , 2010 ) showed that adding glutamine to rat diets reduced injury to the intestinal mucosa following a course of chemotherap y , and Klimberg et al. ( Klimberg et al. , 1990 ) demonstrated that added glutamine protects rat intestinal mucosa following radiation therapy. There were no significant d ifferences between any of the ten events and their respective control varieties for me an gl yco alkaloid toxin content ( Simplot, 2013a)
. RNAi
- mediated gene suppression generally requires sequence homology of at least 90% between the silencing construct and the target sequence to be successful and even higher degrees of homology

over 21
- 23 nucleotide stretches ( Sharp, 2001 )
. Itis not likel y that the genetic construct components responsible for gene silencing in the Simplot events would contribute to silencing of genes in other non
- target organisms through direct cons umption of pollen by59

pollinators or through secondary exposure of beneficial predator or parasitic arthropods or other potential biological control agents for potato pests ( Lacey et al. , 2001 ) since sequences from arthropods, bacteria, fungi and viruses are expected to be highl y divergent from the sequences used to silence genes in the Simplot potatoes. Furthermore, indirect exposure scenarios are unlikely to lead to impacts t o non - target predators and parasitic arthropods since 1) they may not receive effective doses, 2) intracellular amplification of siRNA, the active gene silencing component derived from dsRNA, is not widely found in insects, 3) environmental and phy siologi cal conditions in the gut may destro y the RNA, 4) and they may not have the appropriate receptors to allow transmembrane movement of dsRNA or the appropriate enz ym e to direct RNAi (e.g. Dicer, Argonaute, RdRP, RNA and DNA helicases) ( Lundgren and Duan, 2013 )
. The introduced genes did not significantl y alter the observed insect pest infestation and disease occurrence or resulting damage in Simplot InnateTM Potato relative to the control line under the ty pical re commended pest management conditions. Therefore, APHI S concludes that based on the compositional similarity of Simplot potato tubers to the parent varieties, the observed interactions of Simplot potatoes with insects and pathogens, and the unlikely impacts of nontarget effects due to RNAi, APHI S concludes that the consumption of or indirect exposure to Simplot tubers or other plant parts is unlikely to have adverse impacts on animals in or near potato fields
. Consumption of Simplot InnateTM Potato is unlik ely to substantially affect non
- target organisms, such as mammals, birds, or insects. Simplot data demonstrates that the composition of Simplot InnateTM Potato does not substantially differ from conventional potato varieties ( Simplot, 2013a)
. Simplot indicated that they have submitted a safety and nutritional assessment of food and feed derived from Simplot InnateTM Potato to the FDA on February 12, 2013 ( Simplot, 2013a) . FDA is presently

evaluating the submission. There is no evidence that animal exposure to Simplot InnateTM Potato would have an y effect or be an y l ess attractive as food, refuge, cover and nesting sit es as non GE varieties of potatoes
. 4.4.2 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 InnateTM potatoes do not require an y changes to agronomic inputs when compared with conventional potatoes ( Simplot, 2013a)
. There would be no change in herbicide use or patterns.60

The silencing of acrylamide potential leads to somewhat heightened levels of asparagine in Simplot InnateTM potato , but levels are within acceptable limits ( OECD, 1997b )
. In the very unlikely event of hy

bridization of Simplot InnateTM potato, resulting progeny may have increased 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 )
. As discussed in Section 4.4.1, Animal Communities , consumption of Simplot InnateTM Po tato is not expected to change herbivore
- plant interactions. Under the Preferred Alternative, potential impacts to plant communities are not anticipated to be different compared to the No Action Alternative. Land use and agricultural production of potatoes under the Preferred Alternative is likely to continue as currentl y practiced. Consequentl y, any impact to plant communities as a result of potato production practices under the Preferred Alternative is the same as the No Action Alternative. 4.4.3 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 Alternative: Gene Flow and Weediness If APHIS selects the Preferred Alternative, no changes in agronomic practices are expected to occur ( USDA
- APHIS, 2013a) which might make potato, including Simplot InnateTM Potato more susceptible to gene flow or w eediness. 4.4.4 Microorganisms No Action Alternative: Microorganisms If APHIS chooses the No Action A lternative , potato crop interactions with microorganisms are e xpected to remain the same. Preferred Alternative: Microorganisms T he evaluation presented in the petition ( Simplot, 2013a) demonstrates that changes in agronomic practices, including practices related to soil preparation (which may impact so il organic material and pH) and to pesticide application (which may directly impact microorganisms), would not be required for production of the ten Simplot Innate TM Potato events. In addition, the ten Simplot Innate TM Potato events are substantially similar to their61

conventional counterparts. Simplot InnateTM Potato would therefore be expected to have the same interactions with soil microorganisms. A safet y assessment of mice fed a diet of GE non - browning potatoes showed no adverse effects in mouse gut mic robiota ( Ll orente et al. , 2011 )
. Based on these results, if APHI S chooses the preferred alternative , impacts to microorganisms resulting from this action are expected to be the same as if the No Action Alternative is chosen. 4.4.5 Biodiversity Potato biodiversity

can be enhanced by

the introduction of new genetic material from the large number of exist ing genetic resources available. 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 fairl y constant acreage devoted to potat o production in the U.S. This will allow for continued biodiversity outside the borders of agricultural fields. Biodiversity is expected to continue to be fairl y low within agricultural fields. Preferred Alternative: Biodiversity The evaluation presented in the petition ( Simplot, 2013a) demonstrates that changes in agronomic practices would not be required for production of the ten events. Based on th ese results, if APHI S chooses the Preferred Alternative , an y impacts to biodiversity would be expected to be the same as if the No Action Alternative is chosen. In addition, if APHI S chooses the Preferred Alternative, potato diversity will be enhanced by the introduction of the new events. Under the Preferred Alternative, cultivation, management, and land
- use decisions related to Simplot InnateTM potatoes are not different from conventional potato cultivars . Agronomic practices associated with potato su ch as cultivation, irrigation, pesticide application, fertilizer applications and agriculture equipment would be unchanged. Animal and plant species that ty picall y inhabit potato fields will continue to be affected by currentl y used management plans and s ys tems, which include the use of mechanical, cultural, and chemical control methods. The consequences of current agronomic practices associated with potato production on the biodiversity

of plant and animal communities are unlikely to be altered. Conseque ntly , an y impact to biodiversity as a result of potato production practices under the Preferred Alternative is likely to be identical to the No Action Alternative. 4.4.6 Human Health Potato is primarily

grown for human consumption. U.S. per capita potato consumption is approximately

112 pounds per y ear. Of this, approximately 65 pounds is used for frozen fries or62

chips. Per capita consumption data are shown in Table 6. As discussed in Section 2.5, potential toxins in potatoes are acrylamide , which forms subsequent to high
- temperature cooking, and gl yco alkaloids. P atatin is allergen ic to a very small percent of children. No Action Alternative: Human Health Under th e No Action alternative, consumption of potatoes would be expected to continue at the sam e rate as currentl y . Consumers will continue to be exposed to similar levels of acrylamide in cooked potatoes if other methods are not emplo ye d to reduce levels. Gl yco alkaloids would be expected to remain at sufficiently low levels such that health impac ts would not occur. Patatin would remain a co ncern for allergic individuals
. Preferred Alternative: Human Health I f APHIS chooses the Preferred Alternative , and Simplot InnateTM Potato is widely adopted , acryl amide content in cooked potatoes should be significantl y reduced, leading to health benefits for consume r s. Compared with conventional potatoes, Simplot InnateTM Potato contains, on average, 58 to 72 percent less acrylamide when cooked (NTP, 2011 ; Simplot, 2013a)
. As discussed in Section 2.2.6 , Human Health, the State of California listed acrylamide as a potential carcinogen under Proposition 65 in 1990 and established a No Significant Risk L evel (NSRL) of 0.2 μ g/ 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 ( FDA, 2013b ) recommendations that health
- conscious consumers may want to avoid the consumption of fried potato products
. Especi all y since American consumption of French fries is high ( USDA
- NASS, 2012c ) , these developments regarding acryl amide safet y may lead to processor preference for Simplot InnateTM Potato in French fries and other frozen potato products. T he data presented in the petition shows that the Simplot InnateTM Potato events are at least as safe and nutritious for food as the untransformed controls ( Simplot, 2013a)
. The compositional anal ys es of the ten events are summarized in the petition, with detailed results in Appendix 9 ( Simplot, 2013a) . The compositional assessments determined the amounts of 1) moisture, protein, total fat, ash, crude fiber, carboh ydrate and calories ; 2) vitamins B6, B3 and C ; 3) minerals c opper, magnesium and potassium ; 4) glycoalkaloids ; 5) free amino ac ids; and 6) total amino acids for tubers collected from events grown in 2009, 2010, and 2011 in potato
- growing areas of the United States. Observed c hanges in ASN and reducing sugars accomp lished through transformation o f various potato varieties resulted in lower acrylamide levels in F rench 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 add ition, the research confirm ed that gl yco alkaloid levels were unchanged compared with the control varieties. The potato events described in this petition are no different compositionally compared to untransformed controls , except for the intended traits
. Therefore, issues with allergies would not be expected to exist beyond what individuals with potato allergies would normally experience
. The National Academ y of Sciences (NAS) has ranked methods of genetic modification according to the relative likelihoo d of unintended effects, such as the increase in a plant’s63

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 these ten events is one such method that does not involve 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 mutagenesis, which are not subject to regulation and are not excluded methods under the NOP ( Sciences, 2004 )
. Worker Safety No Action Alternative: Worker Safety If APHIS were to choose the No Action alternative , farm workers would continue to be exposed to the same kinds of hazards as they are currentl y. Preferred Alternative: Worker Safety T here will be no changes in agronomic practices in order to produce Simplot InnateTM Potato
. I f APHI S c hoose s the prefer red alternative , 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. Under the Preferred Alternative, cultivation practices and corresponding worker exposures to agronomic inputs are unlikely to change. Simplot demonstrates in its petition that the agronomic inputs required to cultivate Simplot Innate TM Potato are functional ly equivalent to those required for conventional potatoes ( Simplot, 2013a)
. Accordingl y, the health and safety protocols currentl y emplo yed b y farm workers in the production of potatoes do not require changes to accommodate the production of Simplot InnateTM potatoes
. Based on these findings, APHI S has determined that approval of a petition for nonregulated status of Simplot InnateTM Potato will not impact worker safet y. 4.4. 7 Animal Feed No Action Alternative: Animal Feed As discussed in Section 2.6, Animal Feed , a small portion of the potato crop and waste from processing are sold as livestock feed
. If APH IS selects the No Action A lternative , a small percent of the potato crop would continue to be used for livestock feed. Preferred Alternative: Animal Feed The compositional anal yses of the ten Simplot Innate events are summarized in Section 8 of the petition, with detailed results in Appendix 9 ( Simplot, 2013a)
. In conclusion, the data presented in the petition shows that potatoe s from the events are as safe and nutritious for feed as the untransformed controls , and if APHI S were to choose the preferred64

alternative , the use of potatoes as livestock feed would be no different than if the N o Action alternative was chosen
. **4.5 Socioeconomic Impacts**  4.5.1 Domestic Economic Environment No Action Alternative: Domestic Economic Environment The domestic economic environment is discussed in Section 2.7, Socioeconomic: Domestic Economic Environment

, and potato utilization in t he U.S. is summarized in Table 8 . Potatoes are grown on approximately 1.1 million acres in the U.S., with an annual val ue of approximately $3.5 billion. Major products include fresh potatoes, frozen fries and chips. Organic potatoes account for less than one percent 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 Alternativ e: Domestic Economic Environment If APHIS chooses the P referred A lternative, the ten Simplot Innate TM Potato events will become available for commercial production. Because of the reduced black spot bruise of Simplot InnateTM Potato , it is expected that wastage will decrease significantly , and therefore, revenues will increase. Consumers are likel y to be willing to pay a premium for a healthier food product (such as reduced acrylamide and black spot bruise) developed b y methods of biotechnology which use no foreign DNA ( Huffman, 20 10 ) ; ( Colson et al. , 2011 ) . Overall, if APHI S chooses the Preferred Alternative, the introduction of Simplot InnateTM events are likely to have positive economic impacts, recognizing that some additional costs could be incurred, and as discussed in Section 4.1, no impacts on organic production are expected. Potatoes with low acrylamide potential and reduced black spot bruise 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 becomes available and will be controlled within existing processing channels to ensure that potatoes enter onl y the intended markets. This will provide a period of time to assess consumer acceptance and to address grower and industry concerns . A limited introduction that is initially in a verticall y integrated supply chain will be well controlled b y grower and processor agreements. In this s ituation, conventional products will be considered “identity preserved” with respect to the well
- controlled stewardship of the potato event(s) and its products. As adoption of the potato events increases, programs for identity preservation will be impleme nted as needed. It i s expected that development and implementation of identity preservation sy stems will add some cost to the supply chain ; the total costs will depend upon the ty pe and extent of market penetration ( Simplot, 2013a)
.65

4.5.2 Trade Economic Environment As discussed in Section 2.7, Socioeconomic: Trade Economic Environment, the U.S. exports more than $1 billion in potato products annuall y, primarily consisting of frozen fries and other processed potatoes. Demand from Canada, Mexico and Asia is driving growth in exports. Japan is the largest market for U.S. exports of frozen potatoes, while Canada is the largest U.S. export market for chips and fresh potatoes. The U.S. 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. Preferred Alternative: Trade Economic Environment If APHIS chooses the preferred alternative , U.S. potato exports are expected to continue. Approval for the events will be sought in Canada, Japan and Mexico ( Simplot, 2013) prior to commercial production beginning in the U.S. Previous recalls of potato products that were shipped to Japan and then found to contain geneticall y modified material were related to unapproved events; Japan has zero tolerance for unapproved events ( Reuters, 2001 ) . To assist in the prevent ion of trade disruptions , as has been experienced with other potato events, international approvals will be pursued from key trading partner countries prior to beginning commercial production in the U.S . Simplot intends to follow the recommended stewardship policy statement released by

the Biotechnology

Industry Organization 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 Foo d 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 applica ble regulatory

requirements in key

countries identified in a market and trade assessment that have functioning regulatory s ys tems and are likel y to import the new biotechnology
- derived plant products. The voluntary

guideline was adopted because, according to BIO “as ynchronous authorizations combined with importing 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 on ly increase given the substantial amount of research that will bring many new products and combinations of products to market.” In addition, compared to some biotech crops , the Simplot Innate TM Potato is expected to be viewed more favorably

by regulatory

o rganizations due to the lack of pesticidal traits and marker
- free transformation methods , and therefore have fewer implications for export markets. In an y case, these approvals should ensure continued trade with key export markets.66

If APHIS chooses the preferred alternative , as with the domestic economic environment, the introduction of these potato events may have positive economic impacts on export markets, recognizing that some additional costs could be incurred. Impacts to export markets will be miti gated b y approvals in key trading countries such as Japan, Canada, and Mexico. **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 past, 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” tr aits), 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) define cumulati ve impact as “the impact on the environment which results from the incremental impact of the action when added to other past, present and reasonabl y foreseeable future actions” (40 CFR 1508.7). For example, the potential effects associated with a determin ation 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 Plant Protection Act, in cluding disease tolerance, nitrogen utilization, and herbicide tolerance, would be considered a cumulative impact. **5.1 Assumptions Used for Cumulative Impacts Analysis**  Cumulative effects have been analyzed for each environmental issue assessed in Section 4, Environmental Consequences. The cumulative effects anal ys is is focused on the incremental impacts of the Preferred Alternative taken in consideration with related activities including past, present and reasonably

foreseeable future actions. In this ana ly sis, if there are no direct or indirect impacts identified by a resource area, then APHI S assumes there can be no cumulative impacts. APHI S provides a qualitative assessment of potential cumulative impacts. APHI S considered the potential for Simplot Inn ateTM Potato 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 Potato are indistin guishable from practices used to grow conventional potatoes ( Simplot, 2013a ; USDA
- APHI S, 2013a ) . This implies that 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 Potato could replace other commerciall y available potato cultivars, without requiring production of new, natural lands. As such, land use changes associated with a

pproving the petition are not expected to be an y different than those associated with conventional potato production. APHI S focused the anal ys is of cumulative impacts on the areas in the U.S. that currently produce potatoes.67

Potential reasonabl y foreseea ble cumulative effects are anal yz ed under the assumptions that growers have used in the past and would continue to use reasonable, commonly accepted best management practices (BMPs) for their chosen s ys tem and cultivars during potato production. APHI S rec ognizes, however, that not all growers will use such BMPs. Thus, the cumulative impact anal ys is will make the assumption that not all growers would do so. **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. Because Simplot InnateTM Potato is another potato cultivar that is agronomicall y and compositionally si milar to other commercially available potato cultivars, it is expected that Simplot InnateTM Potato would replace other similar cultivars without expanding the acreage of area devoted to potato production. There are also no anticipated changes to the avail ability of non
- GE potato cultivars on the market. Approving the petition for a determi nation of nonregulated status for Simplot InnateTM Potato is not expected to result in changes to current potato production practices. Studies conducted b y Simplot demon strate that agronomic characteristics and cultivation practices required for Simplot InnateTM Potato are indistinguishable from practices used to grow other potato cultivars ( Simplot, 2013a ; USDA
- APH IS , 2013a )
. Consequently , no changes to current potato production practices associated with the adoption of Simplot InnateTM Potato are expected
. O rganic growers use common practices to maintain the organic status of their potatoes including employing adequate isolation distances between the organic potato field and the fields of neighbors to minimize the chance that pollen will be carried between the fields. Given the importance of maintaining varietal traits and consumer recognitio n and preference for specific potato cultivars , the separation of production and processing of potatoes by cultivars have been utilized by

growers, packers and retailers in the United States market to satisfy consumer preference and demand. Availability o f another potato cultivar , such as Simplot InnateTM Potato , under the Preferred Alternative, is not expected to impact the organic production of potatoes an y differentl y than other potato cultivars currentl y being grown. Based on the info rmation described in Section 4.5.1 , Domestic Trade Environment, APHI S concludes that a determination of nonregulated status of Simplot InnateTM Potato will have no foreseeable adverse cumulative effects on domestic commerce. Simplot InnateTM Potato has the potential to improv e potato processing capabilities and also improve 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 t echnologies to prevent browning. Based on these factors, no net negative cumulative impacts on domestic economics have been identified associated with the production of Simplot InnateTM Potato
. Approving the petition for a determination of nonregulated st atus to Simplot InnateTM Potato 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, water and air qualit y, and climate chang e would not change because Simplot InnateTM Potato is68

agronomicall y similar to other potato cultivars . Because of its similarity to other potato cultivars, adoption of Simplot InnateTM Potato is expected to replace other similar cultivars without changing th e acreage or area of potato production that could impact water, soil, air quality , and climate change. Cumulative impacts due to climate change would be the same for Simplot InnateTM events and conventional potatoes. Potato production in the United States has a fairl y small production footprint (approximately 1 million acres, ( USDA
- NASS, 2012b ) ) when compar ed to row crops like corn (approximately 97 million) and soy

beans (approximately

86 million acres). Considering the production acres, potatoes, including the Simplot InnateTM Potato varieties, will have less impact on climate change than the higher acreage crops. Cumulative i mpacts of the Preferred Alternative to microorganisms and biodiversity would not be significantly different than that experienced under the No A ction Alternative. Simplot InnateTM Potato 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 Simplot InnateTM Potato e vents and conventional potatoes. Multiple years of field data as well as compositional analy sis s how that Simplot InnateTM Potato events are agronomicall y equivalent to conventional potatoes. Also, no changes were observed in land use or agronomic inputs including pesticides and herbicides. Gene flow from potatoes whether biotech or conventional is unl ikely due to the cropping practices of rotation and the clonal propagation of potato varieties in U.S. agriculture. Thus, it would not require an y different agronomic practices to produce , and does not represent a safet y or increased weediness risk that is any different from other currently available potatoes . There are no differences in the potential for gene flow and weediness under the Preferred Action Alternative. Outcrossing and weediness are addressed in the PPRA ( USDA
- APHIS, 2013a )
. Simplot InnateTM Potato is similar to other potato cultivars . The risk of gene flow and weediness of Simplot InnateTM Potato is no greater than that of other pot ato cultivars
. Cumulative impacts to animal communities would be the same for Simplot InnateTM Potato events and conventional potatoes. Three ye ars of field data as well as compositional analy sis and molecular stability

show that Simplot InnateTM Potato eve nts are equivalent to conventional potatoes. Even in cases where asparagine was lower (for reducing acrylamide), the levels were still within the combined literature ranges. In addition, no changes were observed in land use or agronomic inputs including pe sticides. These data show that there is the same impact (and expected cumulative impacts) on non
- target animals or animal communities within the potato agroecos ys tem for Simplot InnateTM events as the conventional potatoes ( Simplot, 2013a)
. Animals consuming Simplot InnateTM Potato may be exposed to increased levels of glutamine, but research on dietary

supplementation with glutamine has not had an y negative animal health effects. Cumulative effects on human consumer health are expected to be the same for Simplot InnateTM Potato events and conventional potatoes, with one exception: the Simplot InnateTM Potato contains significantly

less acrylamide
- forming potential than conventional potatoes. This should result in significant human health benefits, particularly for those with a diet high in French fries and other baked and/or fried potato products. Compared with the conventional varieties, Simplot InnateTM Potato contained on average 58 to 72 percent less acrylamide ( Simplot, 2013a)
. Adoption of these potatoes could result in a significant reduction in dietary intake of acrylamide69

and decrease exposure to this naturally occurring substance found to cause cancer in laboratory animals (NTP, 2011 )
. In addition, gl yco alkaloid levels in Simplot InnateTM Potato were unchanged compared with the control varieties ( Simplot, 2013a) .Although patatin was not measured during the studies, total protein did not differ between Simplot InnateTM and conventional potatoes and it was concluded that any potential allergy

to patatin would be the same. Cumulative impacts to worker safet y would be expected to be the same for Simplot InnateTM Potato events and conventional potatoes. Similarly , Simplot InnateTM Potato is not expected to have an y adverse effect s on l ivestock. Simplot submitted a safety and nutritional assessment of food and feed derived from Simplot InnateTM Potato to the FDA on date February 12, 2013 ( BNF No. 141 ) . FDA is present ly evaluating the submission. No change in food and feed safety is expected to occur under the Preferred Alternative. Cumulative impacts on the domestic economic environment would be similar for Simplot InnateTM Potato events and conventional potatoes, although some economic impact is expected because of the benefits of the new potatoes. These events grow similarl y and have similar biochemical composition to conventional potatoes, however, the low acrylamide, reducing sugars, and black spot bruise traits a dd value that could increase the price received for these potatoes. Potatoes with low acrylamide potential and reduced black spot bruise 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. Cumulative impacts to the trade economic environment would be similar for Simplot InnateTM events and conventional controls, although some economic impact is expected because of the b enefits of the new potatoes. T he U.S. exports more than $1 billion in potato products annuall y, primarily consisting of frozen fries and other processed potatoes ( Council, 2013 )
. Japan is the largest market for U.S. exports of frozen potatoes, while Canada is the largest U.S. export market for chips and fresh potatoes ( Council, 2013 )
. Introduction of Simplot InnateTM Potato will require channeling of the new potatoes into the desired markets. The careful supply chain introduction would be similar to all potato variet y management s ys tems already in place for product purity
. It i s expected that development and implementation of identity preservation sy stems will add some cost to the supply chain ; the total costs will depend upon the ty pe and extent of market penetration ( Simplot, 2013a)
. The Simplot InnateTM Potato could have cumulative economic impacts on the domestic potato market and procedures will be developed to manage product purity in the suppl y chain. Upon introduction, procedures will be implemented to prevent unintended m ixing of Simplot InnateTM with conventional potatoes as part of the stewardship program. In addition, Simplot is seeking international regulatory approvals in areas such as Japan and Mexico for import approval. Also, approval in Canada is being sought for i mport and cultivation. Approval in these key trading countries will minimize market disruption should a low level presence of Simplot70

InnateTM potatoes be found in the market from accidental mixing. In conclusion, the Simplot InnateTM potatoes could have c umulative trade economic impacts on the potato export market and procedures will be developed to manage product purity in the suppl y chain. In conclusion, Simplot InnateTM Potato may offer protection against black spot bruise, slight changes in reducing sugars, and reduced acrylamide potential. During processing, potatoes are routinely culled out due to black spot bruise when making French fries or potato chips, however, with Simplot InnateTM Potato, fewer potatoes will be lost to black spot bruise, resulting in less waste. As a result, there could be increases in yi eld, with associated positive environmental impacts related to land use and agricultural inputs. For the purposes of the cumulat ive impacts discussion, however, it is assumed conservativel y that land use and inputs would potentially decline or remain the same, and are unlikely to increase. R educed levels of acrylamide in cooked potatoes will benefit human health. **6 THREATENED AND**  **ENDANGERED SPECIES** The Endangered Species Act (ESA) of 1973, as amended, is one of the most far
- reaching wildlife conservation laws ever enacted b y an y nation. Congress passed the ESA to prevent extinctions facing man y species of fish, wildlife and plant s. The purpose of the ESA is to conserve endangered and threatened species and the ecos ys tems on which they depend as key components of America’s heritage. To implement the ESA, the U.S. Fish & Wildlife Service (USFWS) works in cooperation with the Natio nal Marine Fisheries Service (NMFS), other Federal, State, and local agencies, Tribes, non
- governmental organizations, and private citizens. Before a plant or animal species can receive the protection provided by the ESA, it must first be added to the Fede ral 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 of any of the following factors:

 The present or threatened destruction, modification, o r 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. Onc e an animal or plant is added to the list , protective measures appl y 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 consultatio n 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 result in the destruction or adverse modification of designated critical habitat.” It is th e responsibility of the federal agency taking the action to assess the effects of their action and to consult with the USFWS and NMFS if it is determined that the action “may

affect” listed species or designated critical habitat. To facilitate their ESA c onsultation requirements, APHI S met with the USFWS from 1999 to 2003 to discuss factors71

relevant to APHIS’ regulatory authorit y and effects analysis for petitions for nonregulated status and developed a process for conducting an effects determination consi stent with the Plant Protection Act (PPA) of 2000 (Title IV of Public Law 106
- 224). APHIS uses this process to help fulfill its obligations and responsibilities under Section 7 of the ESA for biotechnology regulatory actions. APHI S met with USFWS offic ials on June 15, 2011, to discuss whether APHI S has an y obligations under the ESA regarding anal yz ing 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 nece ssary

for APHIS to perform an ESA effects anal ys is on herbicide use associated with GE crops currentl y planted because EPA has both regulatory authorit y over the labeling of pesticides and the necessary technical expertise to assess pesticide effects on th e environment under FIFRA. APHI S has no statutory authorit y t o authori ze or regulate the use of pesticides used by potato growers. Under APHIS’ current Part 340 regulations, APHIS onl y has the authority to regulate the InnateTM Potato or an y GE organism a s long as APHI S 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. After completing a plant pest risk anal ys is, if APHIS determines that seed s , plant s , or part s thereof from Simplot InnateTM Potato do not pose a plant pest risk, then these articles would no longer be subject to the plant pest provisions of the PPA or to the regulatory requirements of 7 CFR Part 340, and therefore, APHIS must reach a determination that th ese article s are no longer regulated. As part of its EA anal ys is, APHI S is analyzing the potential effects of these potato events on the environment including , as required by the ESA, an y potential effects to threatened and endangered species and critical habitat. As part of this process , APHIS thoroughl y reviews the GE product information and data related to the organism (generall y a plant species, but m ay also be other geneticall y engineered organisms). For each transgene/transgenic plant, APHIS considers the following:

 A review of the biology and taxonomy

o f the crop plant and its sexually c ompatible 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 an y) are produced in the plant and their quantity ;  A review of the agronomic performance of the plant, including disease and pest susceptibilities, weediness potential, and agronomic and environmental impacts;  Determination of the concentrations of known plant toxicants (if any are known in the plant);  Analy sis to determine if the transgenic plant i s sexually c ompatible with an y threatened or endangered species (TES) of plants or a host of any TES; and  Any o ther information that may i nform 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 determination of nonregulated status of the potato events may have, if an y, on federall y -72

listed TES species and species proposed for listing, as well as designated critical habitat and habitat proposed for designation. Based upon the scope of the E A and production areas identified in the Affected Environment section of the E A , APHIS reviewed the USFWS list of TES species (listed and proposed) for each state where potato is commerciall y produced from the USFW S Environmental Conservation Online Sy stem (ECOS; as accessed February 19, 2014 at http://ecos.fws.gov/tess_public/pub/stateL istingAndOccurrence.jsp ) , ( USDA
- APHIS, 2014c ; 2014a) . Prior to this review, APHIS considered the potential for Simplot InnateTM Potato to extend the range of potato production and also the potential to extend agricultural production into new natural areas. APHI S has de termined that agronomic characteristics and cultivation practices required for Simplot InnateTM Potato are essentiall y indistinguishable from practices used to grow other potato varieties ( USDA
- APHIS, 2013b ; 2013a) , ( Simplot, 2013a)
. Simplot InnateTM Potato may

be expected to replace other varieties of potato currently cultivated, and APHI S does not expect the cultivation of Simplot InnateTM Potato to result in new potato acres to be planted in areas that are not already devoted to agriculture. Accordingl y, the issues discussed herein focus on the potential environmental consequences o f the determination of nonregulated status of Simplot InnateTM Potato on TES species in the areas of the US where potatoes are currently

grown. JR Simplot has used a genetic engineering approach to introduce into the background of commercial potato cultivar s two traits that are of interest to potato consumers, producers and processors: reduced acrylamide potential in certain processed or heated potato products and reduced black spot bruise ( Simplot, 2013a ; Simplot, 2013b )
. Simplot used the single construct pSIM1278 to transform 5 different commercial par ent varieties and created the ten events described in the petition. The objective was to incorporate the same new phenoty pes into each of these important varieties, while maintaining all of the desirable characteristics originally selected b y potato breeders ( Simplot, 2013a) . Unlike most GE agricultural products that have been commercialized to date, the transformation in this instance does not result in production of proteins. The inserted DNA contains silencing cassettes that, when expressed, generate variabl y - sized and unprocessed transcripts. These transcripts trigger the degradation of mRNAs that would normally

code for an enzy

me, like asparagine s ynthetase. This results in much reduced levels of the targeted “silenced” enz ym es ( Simplot, 2013a)
. As described in the petition and PPRA, the potato lines were transformed to silence four different genes in potato: asparagine sy

nthetase
- 1 (

Asn1 ), poly

phenol oxidase
- 5 (

Ppo5 ), potato phosphorylase L ( PhL ) and the starch
- associated R1 gene ( R1 ). The suppression of Asn1 results in potatoes with reduced free asparagine, and the suppression of PhL and R1 results in potatoes with a lower content of reducing sugars. Collectively , the silencing of these 3 genes should result in potato tubers with a reduced acrylamide potential. The suppression of Ppo5 confers the Simplot InnateTM Potato with a non
- browning phenot ype resulting in tubers with reduced black spot bruising ( Simplot, 2013a) , ( USDA
- APHIS, 2013b )
. For its anal ys is on TES plants and critical habitat, APHI S focused on the agronomic differences between Simplot InnateTM Potato and potato varieties currently grown; the potential for increased weediness; and the potential for gene movement to native plants, listed species, and species proposed for listing.73

For its anal ys is of effects on TES animals, APHI S focused on the implications of exposure to Simplot InnateTM Potato, and the potential for an effect r esulting from the gene silencing activity that sets Simplot InnateTM Potato apart from other potato lines currently in production. Potential Effects of Simplot InnateTM Potato on TES and Critical Habitat Threatened and Endangered Plant Species and Critical Habitat The agronomic and morphologic characteristics data provided b y JR Simplot were used in the APHI S anal ys is of the weediness potential for Simplot InnateTM Potato, and further evaluated for the potential to impact TES and critical habitat. Agronomic studies conducted by JR Simplot over several ye ars tested the hy pothesis that the re would be no change in agronomic practices used to produce Simplot InnateTM Potato in comp arison with conventional potato ( Simplot, 2013a ; Simplot, 2013b )
. Agronomic evaluations were conducted in geographical ly distinct sites selected to represent most of the main production areas for each of the five varieties. Characteristics evaluated included time to emergence, vigor, leaf size, leaf curl, vine maturity, disease susceptibil ity , insect damage, yield, specific gravit y, and abiotic stressors (frost, hail, heat, herbicide, and wind) ( Simplot, 2013b ) . Five events (F37, E12, E24, G11 and H37) had statistically

significant increased plant vigor, but the relative difference was small. Five events (F10, F37, E24, G11 and H37) had significant reductions in total yield. There was no o bvious correlation between decreased yi eld and increased disease or pest stress except possibly for event G11, since greater insect stress was observed than in the parental control at four of 48 insect observations on this event. Event J55 had significant ly reduced early

emergence ( Simplot, 2013a)
. However, n o differences were detected between the transformed potato lines 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 these transformed lines ( Simplot, 2013a)
. Potatoes are not known to be weedy or persistent; they are incapable of survival outside of cultivation ( Holm et al. , 1979 ) , ( Love, 1994b ) , ( Muenscher, 1980a) , ( OECD, 1997a ; 1997b )
. Potato tubers have a fairly low frost tolerance; shallow tubers and those exposed to the surface are often destro yed b y frost, but in temper ate climates up to 20% of tubers left in the soil show no dormancy

and will sprout the next season ( Andersson and de Vicente, 2010 ) . Volunteer potatoes, growing from overwintered tubers, can be a weed problem in the following crop but are easily controlled with cultivat ion and herbicides and do not persist as weeds for more than a few ye ars ( Andersson and de Vicente, 2010 )
. The data presented b y Simplot demonstrate that Simplot InnateTM Potato is, for the most part , phenoty pically and agronomically

similar to the respective parent varieties and do not exhibit meaningful changes in characteristics that would make them weedier or more persistent than their respective parent varieties ( Simplot, 2013a) . Because of the reductions in emergence and yi eld, some of the Simplot InnateTM Potato events appear to have a reduced potential for weediness ( USDA
- APH IS, 2013a)
. Furthermore, JR Simplot did not observe an y differences during the completed post
- harvesting volunteer monitoring of the Simplot InnateTM Potato field test sites from 3 years of field testing that would indicate that these potatoes have prop erties that74

would increase their survivability compared to conventional potatoes. Volunteers were rarel y observed, were easil y controlled, and are not engineered for resistance to herbicides ( Simplot, 2013a) . Based on the agronomic field data and literature survey concerning weediness potential of the crop, APHI S has determined that the Simplot InnateTM Potato is unlikely to persist as a troublesome weed or to have an impact o n current weed management practices ( USDA
- APHIS, 2013a)
. APHI S evaluated the potential of Simplot InnateTM Potato to cross with native plants and listed species , and the possibility that such crosses could result in hy brids that could affect critical habitat . As discussed thoroughl y in sections 2.4.3 and 4.4.3 Gene Flow and Weediness , APHI S 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 Potato
. The events derived from Russet Burbank produces few flowers and is male sterile, and those derived from variety “H” are completely

sterile ( Simplot, 2013a ; Simplot, 2013b ) . The events derived from Ranger Russet, Atlantic, and “G” are likely to produce fertile pollen, but this should have little cons equence in regards to gene flow to related plants. Among native Solanum spp. in the US, cultivated potato is potentially

sexually
- compatible only with two tuber
- bearing species, S. jamesii and S. stoloniferum (previously S. fendleri ( Spooner et al. , 2004a ; Spooner et al. , 2004b ) . These two species are found onl y 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 ( Simplot, 2013a) , ( USDA
- NRCS, 2013b ; 2013a) , ( USDA
- NRCS, 2013a ; 2013b ) . As discussed thoroughl y in the PPRA, numerous biological and geographic obstacl es make gene flow from these cultivated potato varieties to the two wild relatives a highly unlikel y occurrence , and there have been no reports that such crosses have ever occurred naturally ( Love, 1994a ; Love, 1994b ) , ( US
- EPA, 2011b ; 2011c ) . However, because it is scientifically plausible that cultivated potatoes could hy bridize with S. stoloniferum, the PPRA considered the potential impact on the weediness of S. stoloniferum if gene introgression from Simplot InnateTM Potato were to occur. The resulting analy sis concluded that the novel phenot ypes (low acrylamide potential and reduced black spot bruise) did not impart an y significant change in the agronomic properties or response to biotic or abiotic stresses that would cause them to be more weedy ( USDA
- APHIS, 2013b ; 2013a)
. A review of the USFWS database of listed species indic ates that there are three species of the Solanaceae famil y in the genus Solanum that are listed as endangered. Aiakeakua popolo ( 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 ) found only in the U.S. Virgin Islands ( USFWS, 2 014a) . Crosses between these species and Simplot InnateTM Potato would be highl y unlikel y because these species are not found in areas of potato production and even if they

were found together, crosses would be unlikely because the biology

of potato as described in sections 2.4.3 and 4.4.3 Gene Flow and Weediness, and in the PPRA ( USDA
APHI S, 2013a )
. Based on agronomic field data, literature surveyed on potato weediness potential, and the unlikelihood of cros ses with wild relatives, APHIS has concluded that Simplot InnateTM Potato will have no effect on threatened or endangered plant species or critical habitat
.75

Threatened and Endangered Animal Species For its effects analy sis on TES animal species, APHI S focus ed on the likelihood of species to be exposed to Simplot InnateTM Potato and possible effects that could occur as a result of such contact. Exposure of TES species to Simplot InnateTM 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 human intervention. Threatened and endangered animal species that may be exposed to Simplot InnateTM Potato would be thos e TES that inhabit potato fields and may feed on Simplot InnateTM Potato . Few if an y 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, especiall y potato fields. In an Environmental Assessment on the use of genetically engineered corn and so ybean 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 antillarum ), and Sprague’s pipit ( Anthus spragueii; a candidate species) occasionall y 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 b y s andhill cranes ( USDA
APHI S, 2013d)
. As discussed in Section 2.4.1 , 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 b )
. Known exceptions are whitetail deer, wild boar, and voles ( Marinette County , 2014 ) , ( O'Brien, 2005 ) , ( Taylor, 2014 ) . There are two listed sub
- species of whi te - 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 Count y, 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 o f significant potato prod

uction as indicated in Figure 1, Potato 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 Florida far from any commercial potato production ( USFWS, 2014c ) . The three vole species are listed as endangered. The Amargosa vole ( Microus californicus scirpensis ) is found in Inyo Count y i n southeast California which is not an area of potato production ( USFWS, 2014b ) . The Florida salt marsh vole ( Mi crotus pennsylvanicus dukecampbelli ) is found in saltmarshes of Lev y 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 , Arizona, 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 unlikel y, APHIS considered the possible effects on TES if they were to consume Simplot InnateTM Potato. Detailed compositional anal ys es of the ten events are found in Appen dix 9 of the petition. The compositional assessments determined the amounts of 1)76

moisture, protein, total fat, ash, crude fiber, carbohydrate and calories ; 2) vitamins B6, B3 and C ; 3) minerals copper, magnesium and potassium ; 4) gl yco alkaloids ; 5) free amino ac ids; and 6) total amino acids for tubers collected from events grown in 2009, 2010, and 2011 in potato
growing areas of the United States ( Simplot, 2013a ; Simplot, 2013b )
. The potato events described in th e petition were found to be no different compositionally when compared to untransformed controls , except for the intended traits ( Simplot, 2013a ; Simplot, 2013b )
. As discussed in Section 4.4.6 Human Health, issues with allergies to Simplot InnateTM Potato would be unlikely

beyond what individuals with potato allergies would normall y experience
. The modifications did not alter the qualit y of potato as food other than lower levels of acrylamide after cooking, and lower black spot bruise. Simplot submitted a safety and nutritional assessment of food and feed derived from Simplot InnateTM Potato to the FDA on February 12, 2013 ( BNF No. 141) ( Simplot, 2013a ; Simplot, 2013b ) . FDA is presentl y evaluating the submission. As discussed in Section 4.4.1 , 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 ecos ys tem during the field trials , leading to the conclusion that Simplot InnateTM potatoes would have the same impact on other organisms as conventional potatoes ( Simplot, 2013a ; Simplot, 2013b )
. There is no evidence that animal exposure to Simplot InnateTM Potato would have any effect or be any

less attractive as food, refuge, cover and nesting sites as non GE varieties of potatoes. APHI S considered the possibility that Simplot InnateTM 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 an y threatened or endanger ed species ( USDA
APHI S, 2014a ; 2014b )
. Co nsidering 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 Potatoes an d their progen y are expected to have no effect on threatened or endangered animals. Summary After reviewing the possible effects of allowing the environmental release of Simplot InnateTM Potato , APHI S has not identified an y stressor that could affect the reproduction, numbers, or distribution of a listed TES or species proposed for listing. APHI S also considered the potential effect of a determination of nonregulated status of Simplot InnateTM Potato on designated critical habitat and habi tat 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 particularl y competitive plant species and has been selected for domestication and cultivation under conditions not normally

found in natural settings ( Holm et al. , 1979 ; Muenscher, 1980b ; Muenscher, 1980a ; Love, 1994a ; Lo ve, 1994b ; OECD, 1 997a ; 1997b )
. There is no ability of Simplot InnateTM Potato to naturally hy bridize with any

wild Solanum species, including listed species. Simplot InnateTM Potato will not serve as a host s pecies for an y listed species or species77

proposed for listing. Consumption of Simplot InnateTM 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 Potato , and the corresponding environmental release of th ese potato events will have no effect on listed species or species proposed for listing, and would not affect designated habitat or habitat p roposed 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**  **CUTIVE ORDERS, STAND ARDS, AND TREATIES**  **RELATING TO ENVIRONMENTAL IMPACT**  **S 7.1 Executive**  **Orders with Domestic Implications** The following executive orders require consideration of the potential impacts of the Federal action to various segments of the population.

 **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, poli cies, 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 also 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 Risks,”**  acknowledges that children may suffer disproportionatel y from environmental health and safet y risks because of their developmental stage, greater metabolic activity

levels, and behavior patterns, as compared to adults. The EO (to the extent permitted by

law and consistent with the agency ’s mission) require s each Federal agency

to identify , assess, and address environmental health risks and safet y risks that may

disproportionately

affect children. The No Action and Preferred Alternatives were analyzed with respect to EO 12898 and EO 13045. Neither alternati ve is expected to have a disproportionate adverse effect on minorities, low
- income populations, or children. Based on the information submitted by the applicant and reviewed by APHIS, Simplot InnateTM Potato is agronomically, phenoty pically , and biochemica lly similar to conventional potatoes except for the low acryl amide potential and reduced black spot bruise trait. To establish that the new cultivars are nutritionall y equivalent to their parent cultivars, Simplot InnateTM Potato and the control Ranger Ru sset potato were subjected to nutritional and proximate analy sis, and measured for free amino acids, total amino acids, gl yco alkaloids, sugars, and acrylamide levels. Results of the anal ys is are described below.78

Reduced free asparagine (ASN) and total AS P + ASN, increased free GLN and total GLU + GLN, reduced acrylamide, and lowered reducing sugars were observed and expected as a result of gene silencing. This reduction would benefit consumers b y addressing a food safet y issue that is of concern to the p otato industry (NTP, 2011 ) . Other significant differences occurred that were not expected. J3 tubers contained an average of 0.117 mg/100 g py ridoxine (vitamin B6) as compared to the controls, which had 0.124 mg/100g. J55 also had decreased p yridoxine. 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 increased sucrose. These observed differences fall within the normal ranges for potatoes. Potatoes also were tested for reducing sugars and acrylamide after storage. Many of the events had l owered levels of reducing sugars at the time of harvest or one month of storage, but significant differences were not routinel y observed after 2
- 5 months. Storage up to 7 months yielded consistently lower acrylamide levels in most events than in the contr ols, although there were exceptions with the G and H varieties. Overall, the modifications from insertion of pSIM1278 resulted in reductions in acrylamide that persisted throughout the storage period. Research also confirmed that there the levels of natural gl yco alkaloids, a tox in commonly found in solanaceous crops including potato, were not increased overall in the events. The safet y limit is 20mg/100g as described b y Sinden ( Sinden, 1987a) . There were, however, higher mean levels of glycoalkaloids in the G event (20.3 mg/100g) and the comparative untransformed control (19.8 mg/100g), but this was attributed to additional handling at the storage sites and subsequent exposure to light and temperature fluctuations. This finding indicates that there would not be safet y issues as a result o f the introduction of the reduced acryl amide potential and low black spot bruise traits in Simplot InnateTM Potato
. Patatin is a storage glycoprotein found in potatoes that makes up approximately 40 percent of the soluble protein in tubers. 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 them; therefore, an y c hanges in patatin levels in Simplot InnateTM Potato would not impact these childre n. The nutritional anal ys is e stablishes the safet y of Simplot InnateTM Potato to humans, including minorities, low
- income populations, and children who might be exposed to them through agricultural production and/or processing. No additional safety precautions would need to be taken. Simplot initiated the consultation process w ith FDA for the c ommercial distribution of Simplot InnateTM Potato and submitted a safet y and nutritional assessment of f ood and feed derived from Simplot InnateTM Potato to the FDA ( Simplot, 2013a) . FDA is presentl y evaluating the submission.79

Based on these factors, a determination of nonregulated status of Simplot InnateTM Potato is not expected to have a disproportionate adverse effect on minorities, low
- income populations, or children. The following executive order addresses Federal responsibilities regarding the introduction and effects of invasive species: **EO 1311 (** 

**US -**  **NARA, 2010** 

**) , “Invasive Species,”**  states that Federal agencies take action to prevent the introduction of invasive species, to provide for their control, and to minimize the economic, ecological, and human health impacts that invasive species cause. Potatoes are not listed in the United States as a noxious weed species b y 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 highl y 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, an y potatoes left in the field would be eliminated b y tilling, field preparations with herbicides, and harsh winters. Potato growers rarely leave the ground fallow to maximize economic return; however, an y potatoes that grew ina dvertentl y in a fallow field would not be protected with insecticide or fungicide and would be susceptible to the Colorado potato beetle and earl y blight. Potatoes are not known to escape from fields or show weediness potential. Potato seedlings grown fr om tubers have difficulty establishing themselves as they are poor competitors against grasses, trees, and shrubs. This characteristic significantly reduces the chance that potatoes will become feral. In addition, the traits incorporated into Simplot Inn ateTM Potato are not associated with weediness and will not help plants thrive outside of cultivation. Based on historical experience with potatoes and data submitted by the applicant and reviewed by APHIS, Simplot InnateTM Potato is not expected to become weedy or invasive. The following executive order requires the protection of migratory bird populations: **EO 13186 (** 

**US -**  **NARA, 2010**

**) , “Responsibilities of Federa**  **l 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 Unders tanding (MOU) with the Fish and Wildlife Service that shall promote the conservation of migratory bird populations. Migratory

birds are not attracted to potato fields for potatoes; however, waterfowl forage extensively

in 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 dyingwaterfowl from the fields. However, the ten Simplot InnateTM Potato events are similar to their conventional co unterparts and would not require additional use of pesticide applications. Simplot InnateTM Potato is therefore expected to have the same interactions with migratory birds as conventional potatoes.80

**7.2 International Implications**  **EO 12114 (** 

**US -**  **NARA, 2010**

**) , “Environmental Effects Abroad of Major Federal Actions”**  requires federal officials to take into consideration any potential environmental effects outside the U.S., its territories, and possessions that result from actions being taken. APHI S has given this EO careful consideration and does not expect a significant environmental impact outside the U.S. in the event of a determination of nonregulated status of Simplot InnateTM Potato . All existing national and international regulatory authorities and phy

tosanitary regimes that currentl y apply to introductions of new potato cultivars internationally appl y equally to those covered b y an APHI S determination of nonr egulated status under 7 CFR part 340. Any international trade of Simplot InnateTM Potato subsequent to a determination of nonregulated status of the product would be fully subject to national phy

tosanitary requirements and be in accordance with phy tosanit ary standards developed under the International Plant Protection Convention ( IPPC, 2010 ) . The purpose of the IPPC “is to secure a common and effective action to prevent the spread and introduction of pests of p lants and plant products and to promote appropriate measures for their control” ( IP PC, 2010 ) . The protection it affords extends to natural flora and plant products and includes both direct and indirect damage by pests, including weeds. The IPPC establishes a standard for the reciprocal acceptance of ph yt osanitary certification among the nations that have signed or acceded to the Convention (172 countries as of March 2010). In April 2004, a standard for PRA of living modified organisms (LMOs) was adopted at a meeting of the governing body of the IPPC as a supplement to an existing standard, International Standard for Phy tosanitary Measure No. 11 (I SPM
- 11, Pest Risk Analy sis for Quarantine Pests). The standard acknowledges that all LMOs will not present a pest risk and that a determinatio n needs to be made earl y in the PRA for importation as to whether the LMO poses a potential pest risk resulting from the genetic modification. APHI S pest risk assessment procedures for genetically engineered organisms are consistent with the guidance deve loped under the IPPC. In addition, issues that may relate to commercialization and transboundary movement of particular agricultural commodities produced through biotechnology are being addressed in other international forums and through national regulati ons. The Cartagena Protocol on Biosafety is a treat y under the United Nations Convention on Biological Diversit y (C BD) that established a framework for the safe transboundary movement, with respect to the environment and biodiversity , of LMOs, which includ e those modified through biotechnology . The Protocol came into force on September 11, 2003, and 160 countries are Parties to it as of December 2010 ( CBD, 2010 ) . Although the U.S. is not a part y to the CBD, and thus not a part y to the Cartagena Protocol on Biosafet y, U.S. exporters will still need to comply with those regulations that importing countries which are Parties to the Protocol have promulgated to comply

with their obligations. The first intentional transboundary movement of LMO s intended for environmental release (field trials or commercial planting) 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.81

LMOs imported for food, feed, 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 subject to transboundary

movement. To facilitate compliance with obligations to this protocol, the U.S. Government has developed a website that provides the status of all regulatory revi ews completed for different uses of bioengineered products (NBII, 2010 ) . These data will be available to the Biosafet y Clearinghouse. APHI S continues to work toward harmonization of biosafet y and biotechnology consensus documents, guidelines, and regulations, including within the North American Plant Protection Organization (NAPPO), which includes Mexico, Canada, and the U.S., and within the Organization for Economic Cooperation and Development (OECD). NAPPO has completed three modules of the Regional Standards for Ph yt osanitary Measures (RSPM) No. 14, Importation and Release into the Environ ment of Transgenic Plants in NAPPO Member Countries (NAPPO, 2009 )
. APHI S also participates in the North American Biotechnology Initiative (NABI) , a forum for information exchange and cooperation on agricultural biotechnology issues for the U.S., Mexico, and Canada. In addition, bilateral discussions on biotechnology regulatory issues are held regularl y with other countries including Argentina, Brazil, Japan, China, and Korea. **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 nonregulated status of Simplot InnateTM Potato (Section 4.2) and determined that the cultivation of Simplot InnateTM Potato would not lead to the increased production or acreage of potato in U.S. agriculture. The ten Simplot InnateTM Potato events do not possess traits that wou ld 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 modification to Simplot InnateTM Potatoes would not result in any changes in water usage for cultivation. As discussed in Section 4.3, there are no expected negative impacts to water resources or air quality

associated with Simplot InnateTM Potato production. Based on these anal ys es, APHIS concludes that a determinatio n of nonregulated status of Simplot InnateTM Potatoes would comply

with the Clean Water Act and the Clean Air Act. **7.4 Impacts on Unique Characteristics of Geographic Areas**  This EA evaluated the potential changes in potato production associated with a determination of nonregulated status of Simplot InnateTM Potato (Section 4.2) and determined that the cultivation of Simplot InnateTM Potato would not lead to the increased production or acreage of potato in U.S. agriculture. The ten Simplot InnateTM Potato events do 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 modification to Simplot InnateTM Potatoes would not result in any changes in water usage for cultivation. As discussed in Section 4.3, there are no expected negative impacts to water resources or air quality

associated with Simplot InnateTM Potato production. Based on these82

anal ys es, AP HI S concludes that a determination of nonregulated status of Simplot InnateTM Potatoes would comply

with the Clean Water Act and the Clean Air Act. **7.5 National Historic Preservation Act (NHPA) of 1966 as Amended**  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 cause effects on historic properties and 2) if so, to evaluate the effects of such undertakings on such hi storic resources and consult with the Advisory Council on Historic Preservation (i.e., State Historic Preservation Office, Tribal Historic Preservation Officers), as appropriate. APHI S’ proposed action, a determination of nonregulated status of Simplot Innate TM Potato is not expected to adversel y 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 an y potential conflict with cultural resources on tribal properties. APHI S’ Preferred Alternative would have no impact on districts, sites, highway s, structures, or objects listed in or eligible for listing in the National Register of Historic Places, nor would it likely cause an y loss or destruction of significant scientific, cultural, or historical resources. This action is limited to a determination of non - regulated status of Simplot Innate TM Potato
. APHI S’ proposed action is not an undertaking that may d irectl y 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 potential to introduce visual, atmospheric, or noise ele ments 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 enjo ym ent of a historic propert y during the operation of tractors and oth er 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 an y 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 Potato is not expecte d to change an y of these agronomic practices that would result in an adverse impact under the NHPA.83

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