Sections A through G Product Characteristics and Experimental Program Page 1 

## TITLE

Sections A through G Product Characteristics and Experimental Program

Submission for Experimental Use Permit B740

Product: Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 )

TEST GUIDELINES :

N / A

DATE

January 30 , 2014

SUBMITTED BY

J.R. Simplot Co. Plant Sciences 5369 W. Irving St., Boise, ID 83706

PAGE COUNT

Page 1 of 9 1Sections A through G Product Characteristics and Experimental Program Page 2



## Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 )

Table of Contents Section A: Chemical and Physical Properties of the Test Chemical

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

Section B: Proposed Experimental Label

................................ ................................ ................................ 4

Section C: Toxicity Data

................................ ................................ ................................ .......................... 6

Section D: Residue Data

................................ ................................ ................................ .......................... 6

Section E: Product Performance Information

................................ ................................ ......................... 6

Section F: Tolerance

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

Section G: Proposed Experimental Program

................................ ................................ .......................... 8

1. Participants

................................ ................................ ................................ ................................ ..... 8

2. Target Pest and Overview of Experim ental Program

................................ ................................ ..... 8

3. States and Acreage

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

4. Experimental Program

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

1.0 Potato Late Blight Resistance Gene (also known as Rpi

- vnt1) Line Selection Trials (R&D)

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

2.0 Potato Late Blight Resistance Gene (also known as Rpi

- vnt1) Disease Efficacy and Sp ecificity Trials
(Regulatory)

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

3.0 Potato Late Blight Resistance Gene (also known as Rpi

- vnt1) Environmental Risk Assessment and
Composition (Regulatory)

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

4.0 Potato Late Blight Resistance Gene (also known as Rpi

- vnt1) Agronomy Optimization Trials
(Commerc ial)

................................ ................................ ................................ ................................ .............. 13

5.0 Potato Late Blight Resistance Gene (also known as Rpi

- vnt1) Demonstration Trials (Commercial)

.... 14

5. Procedures Common to All EUP Trials

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

6. Environmental Assessment of Field Trials Containing the VNT1 protein

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

7. Simplot Design Pr otocol and Biotechnology Management Quality System Documents

............. 17

8. Environmental Report

................................ ................................ ................................ .................... 1Sections A through G Product Characteristics and Experimental Program Page 3

Section A: Chemical and Physical Properties of the Test Chemical

The active ingredient is the Rpi

- vnt1 gene that expresses the VNT1 protein in InnateTM 2.0 branded potato
varieties and confers resistance to the plant pathogen Phytophthora infestans , commonly known as late blight

. The concentration of the VNT1 protein is 3.0x10 - 6 % by weight

. The remainder of the potato would
be considered i nert a s it consists of potato tuber that wo uld not be regulated under FIFRA. Please see detailed submissions on Product Chemistry and Composition (885.1100, 885.1200, 885.1400) and Physical and Chemical Properties (830.6302, 830.6303, 830.6304). Also, p lease see EPA Form 8570

- 4 Confidential

Statem ent of Formula for additional information.Sections A through G Product Characteristics and Experimental Program Page 4

Section B: Proposed Experimental Label



## Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 )

EPA EXPERIMENTAL USE PERMIT NUMBER: 8917

- EUP

- R

This package contains seed for late blight resistant potatoes that contain the Rp1

- vnt1 gene that expresses the VNT1 protein with efficacy against Phytophthora infestans . The InnateTM 2.0 seed is derived from Russet Burbank, Ranger Russet, Atlantic, or Snowden potato varieties.

For Experimental Use Only

For use only at an application site of a Cooperator and in accordance with the terms and conditions of the Experiment al Use Permit (EUP). This labeling must be in the possession of the user at the time the potato seed is planted. Not for sale to any person other than a Participant or Cooperator of the EPA

approved Experimental Use Program.

Active Ingredient:

Rpi

- vnt1 gene that expresses the VNT1 protein.

3.0x10 - 6 % by weight.

Inert Ingredient:

Potatoes are greater than 99% inert ingredients by weight.

EPA ESTABLISHMENT NO. 008917

- ID

- 035

DISTRIBUTOR/MANUFACTURER J.R. Simplot Company 5369 West Irving Str eet Boise, Idaho 83706

NET CONTENTS: Will be shipped in various sized containers for research

DIRECTIONS FOR USE

Use of this seed in a manner inconsistent with the terms of the Experimental Use Permit (EUP) is a
violation of Federal law. This seed containing the Rp1

- vnt1 gene expressing the VNT1 protein (plant

incorporated protectant) may only be used according to the field protocols as specified in the approved EUP program. Cooperators must have a copy of each applicable protocol prior to initiati ng any research with these contents. Store at conditions between 45 and 50 degrees F with at least 80% humidity. This is a

non

- food EUP. No seed or potato products produced from this seed may enter the food or feed chain in the United States or any other c ountry. All movement of seed shall be recorded in Record of Transport forms and archived by the J.R. Simplot Company to maintain chain of custody.Sections A through G Product Characteristics and Experimental Program Page 5 STORAGE AND DISPOSAL

S torage: Store in a cool dry place.

Pesticide disposal: Any seed not used in these experiments must be returned to the seed provider or disposed of using one of the following methods:



### A. By treating with systemic herbicides ;
B. By disking, tillage, or hand weeding in the field;

C. By deep pit burial in the field;

D. By autoclaving at 121 °C f or 30 to 45 minutes;

E. By freezing;

F. By freeze drying;

G. By grinding;

H. By composting in a restricted access area; and

I. By desiccating, crushing or burning

J. By landfill designed for permanent disposal

Container disposal: Ensure that the bag is completely empty o f seeds before reuse or destroying.Sections A through G Product Characteristics and Experimental Program Page 6

Section C: Toxicity Data

Data waivers for toxicity data are included in this EUP submission. Exact concentration of the VNT1 protein
is unknown but is below the limit of detection of 30 ppb. Molecular characterization dat a show positive
evidence of insertion of the Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 )

. Other evidence for successful expression of the Rpi

- vnt1 gene is in the RNA expression shown in the document titled :
Pr ocedure for Analyzing Rpi

- vnt1 Expression by RT

- qPCR in Potato Leaf

. Additionally, late blight efficacy is demonstrated in inoculated field trials which are discussed in Section E. Furthermore, the Potato Late Blight Resistance Gene (also known as Rpi

- vnt 1 ) shows approximately 90% homology with other resistance genes such as the tomato mosaic virus in consumed plants

. A bioinformatics search showed no homology between the VNT1 protein and known allergens or toxins.

Section D: Residue Data

Data waivers for residue are included in this EUP submission. The level of VNT1 protein exp ression in plants containing the Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) is below the detection
limit and therefore not measurable.

Section E: Product Perf ormance Information

Introduction
Field trials were conducted in 2012 and 2013 to test the efficacy of the Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) in Innate TM 2.0 potatoes against the US

- 8 and US

- 23 strains of late blight.

Purpose and Methods The purpose of the study was to evaluate the foliar resistance of Potato Late Blight Resistance Gene (also
known as Rpi

- vnt1 ) to Phytophthora infestans (late blight) compared with the controls and commercially

available reference varieties. Three field sites (Idaho, Michigan, and Pennsylvania) were planted in randomized complete block design s , each with four replicates. Each plot consisted of five plants spaced approximately 12 inches apart . Plots were bordered by a known susceptible variety such as Atlantic to serve as spreader rows for late blight infection. The spreader rows were inoculated with late blight at row closure. The following late blight str ains were used: US

- 8 in Idaho and US

- 23 in Michigan and Pennsylvania. Plots were visually assessed for symptoms of late blight infection at regular intervals and the percentage of
leaf area affected was recorded.

Results and Conclusions
The results of the study are presented in Table 1. The high level of infection observed in the conventional controls and reference varieties demonstrate the inoculation method was effective in introducing late blight to the field trials. The results show that the Potato Lat e Blight Resistance Gene (also known as Rpi

vnt1 ) was highly and significantly resistant to late blight infection compared to the controls.Sections A through G Product Characteristics and Experimental Program Page 7

Table 1. Percent Leaf Area Affected by Late Blight Across All Sites

Lines Percent Leaf Area Affected by Late Blight
Final Observation P

- value

InnateTM branded Potato Late Blight Resistan ce (also known as Rpi

- vnt1 ) 1 0.4 p<0.0001

Controls 2 80.9

Reference Range 3 18.8

- 100.0 N/A

1 N=156; includes W12, W3, W38, W8, X10, X12, X17, X19, X6, X7, Y15, Y4, and Y9

2 N=36; includes Atlantic, Burbank, and Ranger

3 N=48; includes Bintje, Golden Sunburst, Nicolet, and TX278

Section F: Tolerance

N o tolerances are being requested as part of this EUP and therefore this section is not applicable

.Sections A through G Product Characteristics and Experimental Program Page 8



## Section G: Propos ed Experimental Program

1. Participants

The experimental use program will be under the overall management of the following scientist:

Pete Clark , Ph.D. Biotech Regulatory Manager J.R. Simplot Co.



## 2. Target Pest and Overview of Experimental Program

The target pest to be evaluated in the p roposed experimental program is Phytop h th o ra infestans

, an oomycete, the causa l agent of late blight. Late blight is known to be a major pest of potatoes in North

America and throughout the world

. Late blight resistance was introduced into potato varieties by inserting the Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) through Agrobacterium
mediated transformation. The Rpi

- vnt1 gene was first discovered in the wild potato species Solanum

venturii . Late blight, which caused the Irish potato famine from 1845

- 1849, is still ubiquitous in the
United S tates and Europe and causes extensive crop l oss every year. Simplot Plant Sciences has
transformed the Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) into common potato cultivars such as Ranger Russet and Russet Burbank, all members of the species Solanum tuberosum.

The proposed EUP will include five studies as summarized below in Table 1.

Table1. Proposed Field Trials for January 2014

– October 2014

Protocols Acres Lbs. of Seed

1.0 Rpi

- vnt1 Late Blight Line Selection Trials (R&D) : 5.50 13,750

2.0 Rpi

- vnt1 Late Blight Efficacy and Specificity Trials (Regulatory) : 0.75

.0 1,875

3.0 Rpi

- vnt1 Late Blight Environmental Risk Assessment and Composition (Regulatory):
Trials : 3 .50 8,750

4.0 Rpi

- vnt1 Late Blight Ag ronomy Optimization Trials (Commercial) : 66.00 165,000

5.0 Rpi

- vnt1 Late Blight Demonstration Trials (Commercial) : 20.00 50,000
Totals 95.75 239,375Sections A through G Product Characteristics and Experimental Program Page 9



## 3. States and Acreage

A summary of proposed studies showing the acres by state is shown below in Table 2.

Table 2

. Proposed Experimental Use Program For Plantings From January 2014 Through October 201 4

States To tal Acres with Rpi

- vnt1 Total Sites

ID 10.75 11

MI 6.75 8

NC 2.00 2

ND 3.00 4

NE 60.00 2

NY 2.00 2

OR 0.50 1

PA 2.75 5

WA 6.00 7

WI 2.00 2
Totals 95.75 43

In Section 4, Experimental Program, which follows, all the study designs are included for the EUP. For each study protocol, numbered 1

- 5

, we have included the Objectives, Description, Vectors and Potato Varieties

, Site s, and A creage per Site

. Following the protocols, in Section 5, we include procedures for managing the
research that will be common to all the studies.Sections A through G Product Characteristics and Experimental Program Page 10



## 4. Experimental Program

1.0 Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) Line Selection Trials (R&D )

Objective Production of late blight resistant potatoes requires a new transformation with the vector containing
the Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) for each potato variety. Following transformation, hundreds to thousands of plants are screened to determine the presence of the desired genetic insert. After that initial selection process within labs and greenhouses, approximately 100 plants

are grown in the field for 1 or more years . These first years of field trials are used to observe the plant phenotype and take agronomic measurements to select those varieties expressing the trait while maintaining all the desired characteristics of the parent var iety.

Description Using various experimental plot designs, potato varieties containing the Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) are grown using typical agronomic practice for the geographic area. Plants are observed throughout the growing season, with measurements taken to determine the robustness and expression of desired new traits. Following one or more seasons, events are eliminated until only the 2

- 3 best performers move forward into regulatory trials. Th e following
tables i nclude the vectors and potato varieties and summarize the number of sites by state.

Vectors and Potato Varieties

Vector Varieties
pSIM1678 Burbank W, Ranger X, Atlantic Y, Snowden V

Sites

State Number of Sites

ID 1

MI 1

ND 1

OR 1
A " site " may be comprised of a research or breeding facility or a farm and the growing fields being utilized by such farm or facility.

Acreage per Site

Acres of EUP test plants expressing the Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) : up to

1 .5 per planting.

Total acres of EUP test plants in 2014 : up to 5.5 0 not including any required areas for buffers or
isolation distances.Sections A through G Product Characteristics and Experimental Program Page 11



### 2.0 Potato Late Blight Resistance Gene (also known as Rpi

- vnt1) Disease Efficacy and Specificity Trials (Reg ulatory )

Objective

The late blight efficacy trials will assess the effectiveness of late blight resistance in potatoes transformed
with the Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) , grown in regions of the US most susceptible to this disease

. Trials for specificity will include testing for other common potato diseases, to
show that the Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) is specific for the control of late blight

.

Description

Using various experimental plot designs, potato varieties containing the Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) are grown using typical agronomic practice for the geographic area

. During the growing season, when potatoes are most susc eptible to late blight, potatoes plants are inoculated with strains of the late blight disease agent. Following inoculation, plants are observed to determine the response of transformed plants compared with the parental controls. The following
tables inc lude the vectors and potato varieties and summarize the number of sites by state.

Vectors and Potato Varieties

Vector Varieties

pSIM1678 Burbank W, Ranger X, Atlantic Y, Snowden V

Sites

State Number of Sites

ID 1

PA 1

MI 2
A " site " may be comprised of a research or breeding facility or a farm and the growing fields being utilized by such farm or facility.

Acreage per Site Acres of EUP test plants expressing the Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) : up to
0.25 per planting.

Total acres of EUP test plants in 2014 : up to 0.75 , not including any required areas for buffers or
isolation distances.Sections A through G Product Characteristics and Experimental Program Page 12



### 3.0 Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) Environmental Risk Assessment and Composition (Reg ulatory )

Objective
Field trials will be conducted at multiple sites that represent the primary growing areas for processed potatoes in the US. The studies allow for agronomic and phenotypic data collection to be used in the Environmental and Food Safety Risk assessments required by the USDA, FDA, and EPA for biotech crop approval.

Description Using various experimental plot designs, potato varieties containing the Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) are grown using typical agronomic practice for the geographic area. Observations throughout the g rowing season will allow for an assessment of growth, pest susceptibility, and measurements of tuber yield and quality. Harvested potatoes will be tested for all major nutrients to assess the safety of food and feed

. The following tables include the vectors and potato varieties and summarize the number of sites by state.

Vectors and Potato Varieties

Vector Varieties

pSIM1678 Burbank W, Ranger X, Atlantic Y, Snowden V

Sites

State Number of Sites

ID 2

WA 2

PA 1

ND 1

MI 1
A " site " may be comprised of a research or breeding facility or a farm and the growing fields being utilized by such farm or facility.

Acreage per Site Acres of EUP test plants expressing the Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) : up to
1.0 per planting.

Total acres of EUP test plants in 2014 : up to 3 .5 0 , not including any required areas for buffers or
isolation distances.Sections A through G Product Characteristics and Experimental Program Page 13



### 4.0 Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) Agronomy Optimization Trials (Comm ercial )

Objective

The Late Blight Agronomy Optimization Trials will assess the agronomics and management considerations of potato events transformed with the Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) . Trials will be located in multiple geographies under commercial growing conditions and will test the commercial viability of events and assess appropriate fungicide programs.

Description

Using various experimental plot designs, potato varieties containing the Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) are grown using typical agronomic practice for the geographic area. Plants will be monitored throughout the growing season to assess differences in phenotype and will be rated for disease susceptibility. At harvest, yield, disease presence, and other agronomic data points will be measured to compare the transformed lines to the parental controls. The following tables include the vectors and potato varieties and summarize the number of sites by state.

Vectors and Potato Varieties

Vector Varieties
pSIM1678 Burbank W, Ranger X, Atlantic Y, Snowden V

Sites

State Number of Sites

ID 2

PA 2

NE 2

MI 2
A " site " may be comprised of a research or breeding facility or a farm and the growing fields being utilized by such farm or facility.

Acreage per Site Acres of EUP test plants expressing the Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) : up to
60 per planting.

Total acres of EUP test plants in 2014 : up to 66.00

, not including any required areas for buffers or
isolation distances.Sections A through G Product Characteristics and Experimental Program Page 14



### 5.0 Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) Demonstration Trials (Comm ercial )

Objective

The Late Blight Demonstration Trials will demonstrate the commercial viability of potatoes transformed
with the Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 )

.

Description

Using various experimental plot designs, potato varieties containing the Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) are grown under commercial growing conditions in multiple geographic areas. Plants will be monitored throughout the growing season to assess phenotype and to compare
to commercial ly grown pot ato varieties. At harvest, yield, disease presence, and other agronomic data points will be measured to compare the transformed lines to the parental controls. The following tables include the vectors and potato varieties and summarize the number of sites by state.

Vectors and Potato Varieties

Vector Varieties
pSIM1678 Burbank W, Ranger X, Atlantic Y, Snowden V

Sites

State Number of Sites

ID 5

WA 5

ND 2

WI 2

MI 2

NY 2

NC 2
A " site " may be comprised of a research or breeding facility or a farm and the growing fields being utilized by such farm or facility.

Acreage per Site Acres of EUP test plants expressing the Potato Late Blight Resistance Gene (also known as Rpi

- vnt1 ) : up to

5 per planting.

Total acres of EUP test plants in 2014 : up to 2 0 .00 not including any required areas for buffers or isolation
distances.Sections A through G Product Characteristics and Experimental Program Page 15

5

. Procedures Common to All EUP Trials

Schedule Planting dates: 1/1/14

- 6/15/1 4 Harvest dates: 5/1/14

– 10/15/1 4

Managing Regulated Field Research

Simplot has adopted the Biotechnology Quality Management System sponsored by the USDA. This is a quality management system for regulated crops for the purpose of reducing compliance incidents and to have a consistent system among stakeholders. I ncluded in this appli cation is a subset of procedures for managing regulated trials (see Section 7: Simplot Design Protocol and Biotech Quality Management System Documents ) . The following steps will be followed to ensure containment of regulated potatoes during field trials under an Experimental Use Permit:

1) All study personnel will follow best practice documents and standard operating procedures implemented by the J.R. Simplot Company for the conduct of regulated field trials

.

2) Simplot personnel serve as study direct ors and provide oversight of cooperators to ensure adherence to protocols, best practices, and standard operating procedures

.

3) The J.R. Simplot Company will adhere to all compliance reporting requirements of each government agency that is regulating fie ld trials conducted by our scientists.

The following examples below illustrate how the J.R. Simplot Company adheres to regulatory compliance rules and regulations.
Border rows The EUP test plants or the trial site will be surrounded by one or more fallow border rows

.

Isolation EUP test plants will be isolated in accordance with USDA

- APHIS Performance Standards for regulated
potato trials . Trial sites of regulated potato must be spatially isolated from other cultivated potato by
minimum isolation distance of 30

- feet. The isolation area must be continuous and completely surround the
field release site.

Sampling Plant tissue, whole plant s, and tuber samples may be taken several times during the growing season
and sent to J.R. Simplot Co , or other laboratories for analyses.

Harvest Procedures Plots will be harvested by hand or by machine. R egulated potato material is labeled, contained and
transf erred for s torage and/or further testing after it has been harvested

.

Final Disposition Any remaining vegetative material will be tilled into the soil or otherwise destroyed. Tuber Seed and plant material produced in these trials may be used for analyses or saved for further research or plantings. The following methods can be used to devitali ze and dispose of the regulated potatoes, as applicable:Sections A through G Product Characteristics and Experimental Program Page 16



### A. By treating with systemic herbicides ;
B. By disking, tillage, or hand weeding in the field;

C. By deep pit burial in the field;

D. By autoclaving at 121 °C for 30 to 45 minutes;

E. By freezing;

F. By freeze dryi ng;
G. By grinding;

H. By composting in a restricted access area; and

I. By desiccating, crushing or burning

J. By landfill designed for permanent disposal

Volunteer Plants

Use of GPS coordinates, stakes, markers, or other methods will be used to identify the area where the biotech potatoes are grown, and such an area will be subsequently monitored for volunteers for an appropriate period of time. Volunteers will be terminate d by hand weeding, disking, spraying a n herbicide

, or other method.



### 6

. Environmental Assessment of Field Trials Containing the VNT1 protein

The J.R. Simplot Company is requesting permission to conduct confined regulated field trials under this experimental use permit without requiring destruction of the crop. Potatoes are produce d underground

, in contrast to other row crops such as corn, soybeans, canola, and cotton. Because of this

, it is necessary to let the potatoes mature and set tubers to evaluate yiel d and yield parameters such as grading . These yield and quality parameters are essential for testing the commercial potential of the potatoes . Additionally, as a clonally propagated crop, it takes many years to produce enough tuber seed to conduct research trials. Clonal propagation is required to maintain desired product characteristics and p otato seed does not store from year to year since the tubers are approximately 80% water

. T o keep increasing the seed quantity,
potatoes must be propagated from tubers produced from the previous year’s crop.

Unique aspects of potato biology support the s afe conduct of field trials while minimizing environmental risk. As additional evidence regarding the environmental impact of potato field trials, we have included an Environmental Report that was written for Low Acrylamide potatoes and was submitted to t he USDA ( see Section 8: Environmental Report ). For example, potatoes have relatively short distances for pollen movement resulting in minimal gene flow from field to field as well as the lack of wild relatives in the commercial potato growing regions of t he United States. In short, potatoes have negligible risk of persisting in the environment and becoming weeds. For these reasons

, it is highly unlikely that potatoes will escape and enter the food and feed supply or accidentally enter commerce . Therefore, we would not
recommend crop destruct ion as is typical for crops under EUP B740.Simplot Design Protocol and Biotech Quality Management System Documents Page 17

7. Simplot Design Protocol and Biotechnology Management Quality System Documents

J.R. Simplot Company Design Protocol

P e r f o r ma n c e Stand a rds i n 7C F R 340.3c

1. SHIPPING AND MAINTENANCE AT DESTINATION

 R e g ula t e d potato mat e rial (pl a nts, tube r s, a nd a n y viable mat e ri a l) must be double c ontain e d during mo v e ment/shipping to pr e v e nt unintentional r e l e a s e

.

 Primary (inner) c ont a ine r s : regulat e d mat e ri a l is pl a c e d in sturdy p r im a r y c ontai n e rs ( e

. g ., plastic or po l y p r o p y le n e bo x /b a g s, burl a p b a g s, p a p e r b a g s, tot e s, bins e tc e t e r a ), ca p a ble of containing a ll viable plant mat e ri a l.

 S ec ond a r y (outer) c ontai n e rs : p r im a r y c on t a ine r s a r e s e c u re d in stur d y s ec on d ar y c on t a iner s ( e

. g ., ca rdb o a r d /S t y r o fo a m b ox e s, plasti c /wood e n bin s /totes, e n c losed v e hicl e s e tc e t e r a ),

c a p a b l e of maintai n ing the int e g r i t y of the re g ulat e d m a te r i a l during tr a nsi t

.

 Labeling the Shipping Container (USDA # and Contents): when shipping, the shipping container
must be labeled with the contents and the USDA notification number. USDA notification number must be prominently displayed on the outer most container.

Moving B ulk Material Interstate and Intrastate : Bulk qu a ntiti e s of r e g ulat e d material will be shipp e d using
enclosed tru c k s or shippi n g c on t a iners ( e

. g ., R e e f e r tr a i l e r, trucks with tight fitting tarps, etcetera )

. R e g u l a ted potato e s to and f r om the f i e ld, stor age, or test ing locations will be dir e c t l y l o a d e d into transport vehicles that are ca p a ble of c ontaini n g all regulated material and do not allo w any lo ss to o ccur during shipm ent. The transport vehicles must be locked / closed a nd/or not le f t

un a tt e nd e d, to e nsure the s e c u r i t y of the re g u l a ted mat e ri a l duri n g tr a nsp o rt. Transport vehicles used will be visually inspected before and after use to ensure no regulated material s are left in the transport vehicle. The d r iver a nd a n y o n e h a ndling the re g ulat e d mat e ri a l must r e port to the Simplot

R e g u l a to r y Complian c e c onta c t p e rson immedi a te l y in c a se of a n a cc iden t a l r e l e a se or br e a c h of

c o ntainmen t during shipment

.



###  I n t e rst a te shipm e nts ( ac r oss the Stat e s within the United Stat e s) a r e a cc o m p a nied by a c o p y of

USDA movem e nt a c k nowl e dg e ment letter a nd R ec o r d of T r a nsport with invento r y l ist.



###  Shipm e nts a r e tr a c k e d u s ing shipping ca r ri e r ’s (e

. g ., UP S

, F e d E x ) t rac ki n g numbe r or through electronic communication by shipper/receiver

.



###  Upon r e ce ipt, the r e ce iv e r v e ri f ies the c ontent of the shipm e nt a g a inst the e n c losed invento r y list

a nd s e nds a c o p y o f c ompl e ted R ec o r d of T ra nsport a nd invento r y l ist to shipp e r for r e c o r ds.Simplot Design Protocol and Biotech Quality Management System Documents Page 18



###  I ndividu a l lin e s/ c lones o f re g ulat e d mat e ri a l a re c le a r l y lab e l e d with unique identifi ca tion
number while th e y a re in tr a nsit or in stora g e.



###  Stor a ge units/ a r e a s a re l a b e led a s c ontaini n g re g u l a ted mat e ri a l a nd h a ve c onta c t info r mation for

e m er g e n c y

.



###  R e g ula t e d mat e ri a l is s e g re g a ted f rom non

- re g u l a ted mat e ri a l b y la b e ling a nd/or b y s p a c e to a void

c ombinin g , c on t a min a tion a nd/or mi x ing of mat e ri a l.



###  Contain e rs used for shipping the re g ula t e d mat e r i a l a re dispos e d of or re

- u s e d a ft e r c h ec ki n g that

no r e g ulat e d ma t e rial is le f t behind to avoid unint e ntion a l r e le a s e

.



###  P e rsonn e l h a ndling re g u l a ted m a te r i a l a re t r a ined i n r e lev a nt a sp ec ts of sto r a ge a nd t r a nsport.



###  A c ce ss to the re g ulat e d mat e ri a l is r e strict e d to a uthori z e d p e rsonn e l f r o m the J .R. Simpl o t Compa n y a nd t h e Coll a bor a tive R e s e a r c h Units.

2. INADVERTENT MIXING OF MATERIALS IN ENVIRONMENTAL RELEASE



###  R e g ula t e d potato e s a re p lant e d on l y in the d e s i g n a ted a nd w e l l

- d e fin e d f i e ld re le a s e sit e s, a s mentioned in the USDA a ppro ve d r e le a s e notifi c a tio n

.



###  I ndividu a l lin e s/clon e s a re m ar k e d in the fi e ld using u nique line ide n tifi c a tion or fi e ld d e si g n a tion
numbe r s and a re noted on t h e plot ma p

.



###  R e g ula t e d fi e ld trials a re c le a r l y l o ca ted usi n g G P S c oordin a tes (s e e F ig 1, four c o rn e rs of the fi e ld or

N o r th w e st co r n er , if the trial site is v e r y s mall), a nd a r e re c o r d e d o n the plot m a p.



###  R e g ula t e d potato e s plan t e d in the fi e ld tr i a l a r e f l a nk e d b y a b o rd e r a r ea , ≥ 1 0

- f e e t a t the e nd of the

ro w s a nd ≥ 5

- f e e t on both sid e s ( s e e F ig 1) to a llow c ontainment of re g ulat e d mat e r i a l during

use o f f a rm e qui p ment, implem e nts and/or ma c hine r y

.



###  The bor d e r a rea m a y be le f t f a llow or plant e d with a n a p p rop r iate c o v e r c rop ( for example,

r y e , wh e a t, et c. )

.



###  Th e re must be a minimum of ≥ 30

- fe e t dist a n c e b e tw ee n the out e r e d ge of the re g ulat e d trial

a nd a n y n e i g hbori n g p o t a to fi e ld ( s e e F i g 1 ), a s a n isol a tion dist a n c e for c ontainment

purp o s e s. Isolation area must be maintained free of potato plants or any sexually compatible species throughout the growing season.



###  R e g ula t e d potato e s a re h a rv e sted me c h a ni c a l l y or b y h a nd, d e p e ndi n g u p on the a v a il a bili t y of
f a rm e quipm e nt. All p lant mat e ri a l such a s bo r d e r r o ws, g u a rd r o ws, f il l e r r o ws a nd / or plot e nd

spac e rs (for example, R e d potatoes), if p re s e nt, a re h a rv e sted a nd d e vit a li z e d b y disking in t he f ield, tillage, deep pit buried, chemical treatment, dry/steam heat, composting at Simplot or Simplot collaborators site, or by any other approved method.



###  The e ntire re g ula t e d fi e l d trial, including the bord e r a re a and any area exposed to regulated material during typical farming practices

, will be monito r e d for volunt ee rs in subsequ e nt gro w i n g

se a s ons, a s per S ec tion 6.



###  Planting a nd h a r v e sting e quipm e nt a nd oth e r f a rm implem e nts used in t h e r e g u l a ted tr i a l will be inspe c ted a nd c le a n e d within the r e g ulat e d fi e l d trial a r e a to e nsure no re g ulat e d mat e r i a l is

r e le a s e d into the e nvi r onmen t

.



###  R e g ula t e d potato e s m a y be plant e d in plastic pots, pl ace d in plastic c r a t e s, on top of w e e d
b a r r i e r c loth ( “ Pot T r ia l ” ). I n this ca s e , a border r o w is not n ece ss a r y but the Pot T r ial will be position e d a t l ea st 3 0

- fe e t a w a y f rom n e i g hb o ri n g potato fi e lds.



###  R e g ula t e d potato e s h a r ve sted f r om these trials a re e x p e rime n tal in n a ture a nd a re c ompl e te l y und e r the c ontrol o f the c oll a bor a tive R e s e a r c h U n it a nd the J.R. Simplot Com p a n y . A c ce ss toSimplot Design Protocol and Biotech Quality Management System Documents Page 19

re g u l a ted f ie ld trials is r e strict e d to a uthori z e d p e rson n e l f rom the J .R. S i mpl o t Compa n y a nd t h e Coll a bor a tive R e s e a r c h Uni t

.



###  P e rs o nn e l c ondu c ting field trials a nd h a ndling r e gulat e d mat e ri a l a re tr a i n e d to e nsure that no

re g ulat e d ma t e ri a l ent e rs food or f e e d supp l y

.

3. IDENTITY AND DEVITALIZATION



###  L o ca tion of the r e g ula t e d fi e ld tria l s a nd t h e in d ividu a l lin e s/clon e s in the trial a re m a rk e d a nd

re c o r d e d on a plot map, a s mention e d in s ec t i on 2

.



###  R e g ula t e d fi e ld t ri a ls ar e h a r v e s t e d o r te r min a t e d on or b e fore the e x pir a tion d a te of the

r e le a s e notifi c a tion.



###  R e g ula t e d material s are h a rv e sted a nd stor e d in dedicated storage units a nd a re identi f ied using unique line identifi ca tion numbe r s. Th e se a r e stor e d in w e ll

- d e fin e d a re a s in potato

stor a g e s or in c onst a nt temp e r a ture c oole r s a t the c oll a bor a tive R e s ea r c h Unit or a t t h e J .R.

S implot C o mpa n y f a c ilities a nd a re und e r the c ontrol of t h e Collaborative R e s ea r c h U nit a nd the

J .R. Simplot Compa n y a t a ll times.



###  Stor a ge units a re l a b e l e d a s c ontaini n g re g u l a ted mat e ri a l a nd r ec o r ds of stor a ge a re maintain e d using e le c tr o nic or p a p e r do c uments.



###  A f ter bioch e mi c a l, mol ec ular, a nd other testing, the regulated mat e ri a l a n d/or r e mnants a r e d e vit a li z e d b y a utocl a v i n g , f r e e z i n g , h ea t ing

, o r anaerobic digester as detailed below, or sun d e vit a li z e d/compost e d, deep pit buried, chemical treatment, dry/steam heat, composting at Simplot or Simplot collaborators site, or by any other approved method. If the regulated article is moved to another approved release site location listed on the notification for devit a lization; to include deep pit burial or disking and freezing, then field monitoring requirements for volunteers in the subsequent growing season is required.

Devit a lization and Disposal of Regulated Potatoes using Anaerobic Digester

Introduction : Simplot Plant Sciences can use the Anaerobic Digester adjacent to the processing plant in Grand Forks, North Dakota to devitalize and dispose of regulated potato waste.

Disposal Method: Anaerobic Digester refers to a wastewater/waste solids treatment and biogas production unit that is on site at Simplot’s plant at Grand Forks, ND. Anaerobic digestion is a natural process, occurs in the presence of facultative and anaerobic bacteria, that converts biomass to methane and carbon dioxide under oxygen free conditions. The digestive process involves four phases:

Step 1: Hydrolysis: Large polymers are broken down by enzymes (anaerobic bacteria).
Step 2: Fermentation: Acidogenic fermentations are most important, acetate is the main end
product. Volatile fatty acids are also produced along with carbon dioxide and hydrogen.
Step 3: A cetogenesis: Breakdown of volatile acids to acetate and hydrogen.
Step 4: Methanogenesis: Acetate, formaldehyde , hydrogen and carbon dioxide are converted to

methane and water.
During this process the temperature is maintained at around 25°

- 35°C (mesophilic range) and pH is close to 7. The following diagram explains the biogas process.Simplot Design Protocol and Biotech Quality Management System Documents Page 20

At Simplot’s Biogas facility, potatoes are placed into a maceration process that crushes and blends the elements together to form a liquid solution (less than 40% dry matter). The solution is then sent to the digester (fermentation chamber), where fermenta tion star ts as described above. Once the fermentation

process is started, proteins, nucleic acids, fats, and carbohydrate are quickly broken down to base elements rendering the potatoes non

- viable. The waste potato materials in the fermentation tanks of t he biogas facility are kept for several months to ensure complete digestion. This would kill any part of the tuber that could have survived the crushing and mixing process.

The digested and stabilized solids from the digester are removed once annually. The digested solids will be
used as a soil amendment.

4. VIABLE VECTOR AGENTS



###  R e g ula t e d potato plants a re tr a nsf o rm e d usi n g dis a rm e d Agroba c terium tu m e faci e n s

.



###  T r a nsfo r m e d potato pl a nts a re f r e e d f r om b a c te r ial c on t a min a tion by t r ea tm e nt with a ntibioti c s

spe c ific for A groba c terium tho u g h m ultiple tissu e

- c ultu r e p r o p a g a tions, p r ior to e ith e r

g re e nhouse or fi e l d r e le a s e

.

5. PERSISTENCE IN THE ENVIRONMENT



###  I n a ll c a s e s, re g ulat e d p otato tria l s a r e f l a nk e d b y b o rd e r a r e a s a nd a re isol a ted f r o m the

n e i g hb o ring po t a to fi e ld s , a s mentioned in s ec tion 2.



###  R e g ula t e d plant mat e ri a l (tub e rs/plant tissue/vine s ) le f t in the tri a l site a ft e r h a rv e st, i n c luding
bord e r a r e a p l a nts, if p re s e nt, will be d e vit a li z e d b y diski n g o r d e e p

- pit b u r ial. Disk e d fi e lds a re subj e c ted to winter fr ee z ing a n d / o r sol a r d e vi t a li z a tion a nd n a tur a l d e c omposition.

6. VOLUNTEER PLANTS



###  F ield sit e s us e d for r e gulat e d potato trials will not be used for potato c ultivation for twoSimplot Design Protocol and Biotech Quality Management System Documents Page 21

subsequ e nt g r owi n g s e a sons, a nd inst ea d will be used for small g r a i n s or a lt e rn a tive c r o p

p r odu c tion to f a c ilit a te m onito r ing f or po t a to volunte e rs.



###  F ield trials conducted using plastic containers placed on the crates a bove w e ed

- b a r r i e r c loth, m a y be u s e d f o r subseq ue nt field trials. Ho we v e r , the site will be monitor e d for volunt ee rs.



###  Post

- h a rv e st monitorin g : R e g ula t e d trials will be h a r v e sted / te r min a t e d on or b e fore the

e x pir a tion of the USDA notifi c a tion r e le a s e d a te. F ollowi n g the h a r v e st/te r min a tion, the

r e le a s e site includi n g t h e border a r e a , will be m onito re d month l y f o r vo l unte e rs, when the

environment al conditions are conducive for potato plant growth.



###  Volunt e er s will be d e vi t a li z e d b y diskin g , h a nd w e e di n g, deep pit burial, chemical treatment, dry/steam heat, composting at Simplot or Simplot collaborators site, or by any other approved
method

7. DATA THAT WILL BE COLLECTED

Ge n e r a l a g ronomic p e r f o rm a n c e d a ta will be c oll ec ted f r om the re g ulat e d trial s , including plant

e mer g e n ce , v i g o r , a nd o v e r a ll ph e no t y p e . Tu b e r a ssessme n t s will include bioch e mi ca l a n a l y s e s

.

A n y unus u a l oc c u r r e n ce s noted in the f ield will be immedi a te l y r e port e d to USDA.Simplot Design Protocol and Biotech Quality Management System Documents Page 22Simplot Design Protocol and Biotech Quality Management System Documents Page 23

Biotechnology Quality Management System Document 7.2.1 Storage

1.0 PURPOSE

1.1 This procedure describes the critical control point (CCP) storage of the regulated material, and

the way in which the CCP is monitored and verified.

2.0 DEFINITIONS

2.1 Terms and acronyms that may apply to this procedure are in Annex

- 1 Glossary.

3.0 RESPONSIBILITY

3.1 Permitted Party, Trial Managers, Field Supervisors, or personnel with appropriate training and

authority.

4.0 PROCEDURE

4.1 Regulated GE organisms will be stored in dedicated storage areas or will be spatially segregated

and separated from other organisms, if stored in t he same storage area. Material in the storage will be managed according to the individual systems.

4.2 Designated storage areas are clearly marked and/or labeled as containing regulated GE material

with contact information of Trial Manager for any emerge ncy.

4.3 If the regulated material is stored in containers, the containers are to be of durable construction

maintaining integrity of the regulated GE organisms (e.g., temperature controlled units/rooms/ chambers, cardboard boxes, cabinets, totes, crates , bins, sacks, plastic boxes/bags, mesh bags, cloth bags, paper bags, envelopes or as appropriate for material being stored).

Long term storage : Regulated material is stored for several weeks or months. A record of storage (electronic or paper document) must be maintained for inventory control.

Short term storage : Regulated material is stored for less than a month (e.g., material received for planting , testing, etc.). Shipping records can be used as a storage record.

4.4 If regulated material is stored in bulk, the bulk potatoes should either be in a segregated

warehouse space with walls on all 4 sides, or segregated within a warehouse by partitions of suitable height such that potatoes can’t spill over. There should be s ufficient isolation between regulated potatoes and other potatoes to avoid potential mixing.

4.5 Regulated GE organisms are identified by labeling and/or marking the storage containers with

unique line ID. Where possible, color coding will be used for i dentifying regulated GE organisms.

4.6 Access to regulated GE organisms in storage areas are limited to trained personnel authorized by

Permitted Party or Trial Manager.Simplot Design Protocol and Biotech Quality Management System Documents Page 24

4.7 Regulated material removed from storage for the purpose of disposal must be rendered non

viable using appropriate devitalization methods (Procedure 7.2.5).

4.8 In the event of a confirmed accidental release of regulated material, all attempts shall be made

to recover as much of the regulated material as possible. The accidental r elease incident will be immediately documented (Procedure 7.4.1; Form 8.4.2; and Form 7.4.1) and a copy will be sent to SPS for taking appropriate action.

5.0 REFERENCES

5.1 Procedure 4.2.3 Document control

Procedure 4.2.4 Record control
Procedure 7.2. 5 Devitalization and final disposition Procedure 7.4.1 Potential regulatory compliance incidents

Annex

- 1 Glossary

5.2 Records of storage (Electronic or paper documents)

Form 7.4.1 Record of self

- reporting Form 8.4.2 Corrective/preventive action fo r BQMSSimplot Design Protocol and Biotech Quality Management System Documents Page 25

Biotechnology Quality Management System Document 7.2.2 Transport and Movement, of Regulated GE Organisms

1.0 PURPOSE

1.1 This procedure describes the critical control point (CCP) transport, movement, and import of the

regulated GE organism, and the way in which the CCP is monitored and verified.

2.0 DEFINITIONS

2.1 Terms and acronyms that may apply to this procedure are in Annex

- 1 Glossary.

3.0 RESPONSIBILITY

3.1 Permitted Party, Trial Managers, Field Supervisors, or personnel with appropriate training and

authority.

4.0 PROCEDURE

4.1 Regulated material should be secured within a primary container capable of containing all viable

plant material (e.g., plastic or polypropylene tube/box/bag/envelope, cloth bag, paper bag, mesh bag, totes, crates or as per design protocol). The primary container is placed within a secondary container that is able to maintain the integrity of the regulated material (e.g., large crates, bins, boxes, bags, totes, enclosed trucks, tarped trailers or as per design protocol for material containment). Multiple primary containers can be pla ced within a single secondary container for shipment.

4.2 Each shipment should be accompanied by a Record of Transport (Form 7.2.2) and a copy of

USDA acknowledgement letter. Receiver must be informed by email/phone/fax before the shipment is sent. Shipm ents are tracked using Simplot’s regulated shipment tracking report or shipping carrier’s tracking number or by direct communication with the shipping carrier or

receiver.

Note: If regulated material is shipped in bulk using semi, then the shipper must g ive instructions to the truck driver to ensure proper containment and safety of the regulated material during transit. All required documents must be with driver and the semi must be sealed and locked during transit

.

4.3 Primary containers should be labe led with an identifying number or event name using printed

labels or permanent markers. Secondary containers should be labeled: a) with applicable USDA movement notification number and b) address and contact details of Sender and Receiver.

4.4 When a shipment of regulated material is received; the following actions should be taken

immediately by the recipient (Trial Manager or others with appropriate training and authority):

a) Check and inspect the condition of shipping containers to ensure containment integrity. b) If the shipping container(s) is/are damaged or breached, it should be immediately informedSimplot Design Protocol and Biotech Quality Management System Documents Page 26 to SPS for taking an appropriate action. c) Verify the contents according to the enclosed inventory list. If, the contents don’t match the attached inventory list, then make a note and inform the sender to take appropriate action
as needed. d) Complete the receiver section of the Record of Transport ( Form 7.2.2). Place original in the compliance folder and send a copy to shipper and SPS for records. e) Regulated material should be placed in a designated storage area (Procedure 7.2.1).

4.5 Primary and secondary containers used in transport or shipping of regulated material should be

disposed or return ed to use, only after making sure that no regulated GE material is left in the container. Any regulated GE organisms recovered after cleaning, must be rendered non

- viable (Procedure 7.2.5).

4.6 In the event of a confirmed accidental release of regulated material, all attempts shall be made

to recover as much of the regulated material as possible. The accidental release incident should be documented (Procedure 7.4.1; Form 8.4.2; and Form 7.4.1) and a copy will be sent to Permitted Party to take appropriate action.

5.0 REFERENCES

5.1 Procedure 4.2.3 Document control

Procedure 4.2.4 Record control Procedure 6.2.2 Competency, awareness, and training Procedure 7.2.1 Storage
Procedure 7.2.5 Devitalization and final disposition Procedure 7.4.1 Potential regulatory compliance incidents

Annex

- 1 Glossary

5.2 Form 6.2.2 Record of training

Form 7.2.2 Record of transport
Form 7.4.1 Record of self

- reporting Form 8.4.2 Corrective/ preventive action for BQMS

5.3 External documents

Potato Design protocol USDA Permits/NotificationsSimplot Design Protocol and Biotech Quality Management System Documents Page 27

Biotechnology Quality Management System Document 7.2.3 Environmental Release Planning and Monitoring

1.0 PURPOSE

1.1 This procedure describes the critical control point (CCP) environmental release planning and

monitoring of the regulated material, and the way in which the CCP is monitored and verified.

2.0 DEFINITIONS

2.1 Terms and acronyms that may apply to this pro cedure are in Annex

- 1 Glossary.

3.0 RESPONSIBILITY

3.1 The Permitted Party, Trial Manager, Field Supervisors, or personnel with appropriate authority

and training.

4.0 PROCEDURE

4.1 Pre

- planting handling and transfer to environmental field release site:

Trial Man a ger must have a plot map (Record 7.2.3.d) or a layout of the trial site indicating surrounding land uses, isolation distances employed, and border area, where applicable, before transferring the regulated material to the trial site. Regul ated material must be placed in secure containers for transfer to the trial site to avoid any potential loss of containment.

4.2 Preparation and cleaning of planting equipment:

Equipment and tools used in planting regulated field trials or used in the ma intenance of the trial site must be inspected and cleaned on the trial site prior to their removal to eliminate unintended transport of regulated material from the trial site (Form 7.2.3.a).

Any regulated plant material recovered after cleaning must be r endered non

- viable by using devitalization and disposition methods (Procedure 7.2.5).

4.3 Border markings of the environmental release site:

F our corners of the field release site will be clearly marked using physical markers and/or identified using GPS coordinates. Border area will be measured from the edge of the field trial, as per Design Protocol.

4.4 Documentation of environmental release site:

Trial Man a ger must prepare a plot map (Record 7.2.3.d) for each environmental field release site, as per acknowledged USDA permit/notification for environmental field release for the proposed field trial site. Plot map must provide layout of the site, separation distance employed, border area, as applicable, and surrounding land uses, such as adjacent field p lots, buildings, roads, alleys, fallow zones, and natural ecosystems (water bodies, mountains, flood plains).

Trial Man a ger must record what is planted, date of planting, legal description or location of the trial site, total area planted, and GPS coordi nates by completing Record of Planting (FormSimplot Design Protocol and Biotech Quality Management System Documents Page 28 7.2.3.a). A copy of completed Record of Planting with plot map must be submitted to SPS within five to ten days of planting. SPS will submit planting report to USDA before the fifteenth day of
the month followin g planting.

4.5 Monitoring of field release site for reproductive isolation:

The Trial Man a ger must ensure that the trial site and surrounding isolation areas are kept free of prohibited plants (plant species that are sexually compatible with regulated GE organisms), by implementing a program of regular monitoring and devitalization of any prohibited plants (Procedure 7.2.5). Record of Spatial Isolation (Form 7.2.3.f) must be completed, signed, and dated. A copy of t his record should be sent to SPS after the harvest of the trial.

4.6 Harvest preparation and equipment cleaning:

Trial Manager must communicate with SPS to plan and prepare for the harvest. Record of Harvest (Form 7.2.3.c) is completed to document and verify the following: 1) field release s ite to be harvested, 2) harvest date and 3) cleaning of equipment and tools used for harvesting as mentioned above in 4.2 and send a copy to SPS within one week after harvest. SPS will submit the final field test report to USDA within six (6) months of tri al site harvest or termination.

4.7 In

- season m onitoring of field release site:

The Trial Man a ger or designated personnel must implement in

- season monitoring to ensure the following: 1) Proper reproductive control measures are in place to avoid the spre ad or escape of regulated GE organisms from the release site (see 4.5); 2) Monitor the release site for any deleterious effects on plants, non

- target organisms, or the environment; 3) The release site will be monitored monthly; and 4) Monitor the release site, including alleys; border and fallow zones, for sexually compatible plants and/or viable plant parts or material to control the spread of the regulated GE organisms from the release site (see 4.5).

4.8 Post

- harvest volunteer monitoring of environmental field release sites:

The post

- harvest monitoring period for environmental field release site is two (2) years. Ownership, control, or physical access of the release site must be secured by the Trial Manager for post

- harvest period. During th is period, an alternative crop can be grown at the site to allow monitoring for volunteer plants.

During the post

- harvest monitoring period, the Trial Manager must monitor release site, once a month, including border areas for volunteers (Form 7.2.3.h), and ensure that volunteer plants and/or viable plant parts are devitalized and rendered non

- viable (Procedure 7.2.5).

At the end of each growing season of the two (2) year post

- harvest period, a copy of the monitoring record (Form 7.2.3.h) should be sent to SPS for records.

4.9 Relevant personnel must have training applicable to their defined roles and responsibilities

(Form 6.2.2). In the event of a confirmed accidental release of regulated material, all attempts
shall be made to recover as much of the regulated material as possible. The accidental release incident will be immediately documented (Procedure 7.4.1; Form 8.4.2; and Form 7.4.1) and a copy will be sent to SPS to take appropriate action.Simplot Design Protocol and Biotech Quality Management System Documents Page 29

5.0 REFERENCES

5.1 Procedure 4.2.3 Document control

Procedure 4.2.4 Record control Procedure 7.2.2 Transport, movement and import of regulated GE organisms Procedure 7.2.5 Devitalization and final disposition Procedure 7.4.1 Potential regulatory compliance incidents

Annex

- 1 Glossary

5.2 Record 5.4 Or ganizational chart, responsibilities, and authorities

Record 7.2.3.d Instructions for plot map Form 6.2.2 Record of training Form 7.2.3.a Record of planting Form 7.2.3.f Record of spatial isolation
Form 7.2.3.c Record of harvest
Form 7.2.3.h Record of post

- harvest inspection
Form 7.4.1 Record of self

- reporting Form 8.4.2 Corrective/preventive action for BQMS

5.3 External documents

Design protocol Potato Growing and Confidential agreement USDA Permits/NotificationsSimplot Design Protocol and Biotech Quality Management System Documents Page 30

Biotechnology Quality M anagement System Document 7.2.4 Post

- Harvest Handling and Transfer

1.0 PURPOSE

1.1 This procedure describes the critical control point (CCP), post

- harvest handling and transfer of

the regulated organisms, and the way in which the process is monitored and verified.

2.0 DEFINITIONS

2.1 Terms and acronyms that may apply to this procedure are in Annex

- 1 Glossary.

3.0 RESPONSIBILITY

3.1 The Permitted Party, Trial Manager, Field Supervisors, or personnel with appropriate training

and authority.

4.0 PROCEDURE

4.1 Regulated GE organisms harvested from the field release sites must be transferred to a

designated storage units and/or further testing locations by personnel with appropriate training in relevant aspects of handling and storage of regulated GE material.

4.2 Containment of the GE organisms during transfer to storage/conditioning locations.

a) Intrastate shipments : Where field r elease sites and storage/test ing locations ar e within close proximity and/or in the same state, then the GE organisms are secured in sturdy containers capable of maintaining the integrity of the regulated material (bags, bins, totes, boxes, trucks, etc.), as appropriate, depending on the quantity being transferred. Care must be taken to avoid any spillage during the trans port. b) Interstate shipments (field release sites and storage/test ing locations are in different states: Follow the Procedure 7.2.2 (Form 7.2.2).

4.3 Regulated GE organisms must be clearly identified by labels indicating specific line identification

number and/or name to distinguish from other regulated and/or non

- regulated organisms (Procedure 7.2.1).

4.4 Regulate d GE organisms must be handled by personnel with appropriate training. The following

steps must be taken to avo id any potential mixing with non

- regulated/conventional material and to maintain the identity of t he regulated GE organisms:

a) Ensure proper cleaning of equipment/tools used between tests. b) Ensure that regulated waste material is segregated, devitalized, and that proper
documentation is co mpleted.Simplot Design Protocol and Biotech Quality Management System Documents Page 31

4.5 Equipment and/or tools used for regul ated GE organisms must be inspected and cleaned, as

necessary before and after their use to eliminate unintended transport of regulated organisms
from the confined area.

4.6 Any misidentified regulated GE organisms must be rendered non

- viable (Procedure 7.2.5). In the

event of a confirmed accidental release of regulated organisms, all attempts shall be made to recover as much of the regulated organisms as possible and render non

- viable (Procedure 7.2.5)

. The accidental release incident should be documented (Procedure 7.4.1; Form 8.4.2; and Form 7.4.1) and a copy will be sent to Permitted Party for appropriate action to be taken.

5.0 REFERENCES

5.1 Procedure 4.2.3 Document control

Procedure 4.2.4 Recor d control Procedure 6.2.2 Competence, awareness, and training Procedure 7.2.1 Storage Procedure 7.2.2 Transport, movement and import of regulated GE organisms Procedure 7.2.5 Devitalization and final disposition Procedure 7.4.1 Potential regulatory compliance incidents

Annex

- 1 Glossary

5.2 Form 6.2.2 Record of training

Form 7.2.2 Record of transport
Form 7.2.1.c Record of ma terial transfer and termination
Form 7.4.1 Record of self

- reporting

Form 8.4.2 C orrective/ preventive action for BQMSSimplot Design Protocol and Biotech Quality Management System Documents Page 32

Biotechnology Quality Management System Document 7.2. 5 Devit a lization and Final Disposition

1.0 PURPOSE

1.1 This procedure describes the critical control point (CCP), devitalization and final disposition of

the regulated material, and the way in which the CCP is monitored and verified.

2.0 DEFINITIONS

2.1 Terms and acronyms that may apply to this procedure are in Annex

- 1 Glossary.

3.0 RESPONSIBILITY

3.1 The Quality Management Representative, Trial Managers, Field Supervisors, or personnel with

appropriate training and authority.

4.0 PROCEDURE

4.1 Regulated plant material in the confined field release site , including border rows, that is not

retained for research purposes must be rendered non

- viable using applicable devitalization and disposition methods and must be documented.

4.2 Regulated material removed from storage and/or other means of containment for the purpose

of disposal must be rendered non

- viable using applicable devitalization and disposition methods
and must be documented.

4.3 Methods of Devitalization and Disposition

Methods of devitalization and final disposition of regulated GE organi sms may include, but is not limited to, the following methods as applicable:



### A. By treating with systemic herbicides ;
B. By disking, tillage, or hand weeding in the field;

C. By deep pit burial in the field;

D. By autoclaving at 121 °C for 30 to 45 minutes;

E. By freezing;

F. By freeze drying;

G. By grinding;

H. By composting in a restricted access area; and

I. By desiccating, crushing or burning

J. By landfill designed for permanent disposal

4.4 Trial Manager and/or SPS must maintain the records of devitalization and final di sposition

(Procedure 4.2.4) of regulated material in the field and storage.

4.5 Devitalized regulated material will be disposed into a landfill.Simplot Design Protocol and Biotech Quality Management System Documents Page 33

5.0 REFERENCES

5.1 Procedure 4.2.3 Document control

Procedure 4.2.4 Record control
Procedure 6.2.2 Competency, awareness and training

Annex

- 1 Glossary
CIS website

5.2 Form 6.2.2 Record of training

Form 7.2.1.a Record of storage
Form 7.2.1.c Record of material transfer and termination Form 7.2.3.a Record of planting
Form 7.2.3.c Record of harvest
Form 7.2.3.h Re cord of post

- harvest inspection

5.3 External Documents Potato design protocolSimplot Design Protocol and Biotech Quality Management System Documents Page 34

Biotechnology Quality Management System Document 7.4.1 Potential Regulatory Compliance Incidents

1.0 PURPOSE

1.1 This procedure describes the pro cess for reporting potential regulatory compliance incidents to

appropriate regulatory authorities for prompt incident remediation and resolution; the way in which the process is monitored; and whether the monitoring and verification, as well as changes

in those activities, are effective. The species of regulated GE organism addressed in this procedure is potato.

2.0 DEFINITIONS

2.1 Terms and acronyms that may apply to this procedure are in Annex

- 1 Glossary.

3.0 RESPONSIBILITY

3.1 The Quality Management Representative, Trial Managers, Field Supervisors, or personnel with

appropriate training and authority.

4.0 PROCEDURE

4.1 Trial Manager or relevant personnel will document any compliance incidents discovered and

communicate immediately to SPS QMR by phone, e

- mail or fax, explaining the nature and type
of the incident occurred.

4.2 Trial Manager or relevant personnel responsible must document the compliance incide nt

discovered by completing the Record of Self

- reporting (Form 7.4.1) and fax or e

- mail a copy to SPS QMR for resolution. The flow chart in Figure 1, explains the process for self

- reporting compliance incidents and resolution of compliance incidents.

4.3 SPS QMR upon receiving the incident report from Trial Manager or relevant personnel will

review the incident internally. In the event that QMR confirms that an accidental release has occurred, the QMR will then notify USDA/APHIS for appropriate action as d escribed in the flow chart Figure 1.

4.4 In the event of a confirmed accidental release of regulated material at any stage, all attempts

shall be made to recover as much of the regulated material as possible. If needed, all recovered regulated material mu st be devitalized as appropriate (Procedure 7.2.5). The period of monitoring of the incident site will be determined in consultation with USDA/APHIS.

4.5 APHIS web site for instructions for compliance incidents:

http://www.aphis.usda.gov/biotechnology/compliance_incident.shtml

4.6 SPS QMR or designee will ensure that relevant personnel involved in regulatory compliance

incidence reports are adequately trained in the releva nt aspects (Procedure 6.2.2; Form 6.2.2). SPS QMR will ensure that the training is implemented and effective by interviews, site visits,Simplot Design Protocol and Biotech Quality Management System Documents Page 35 audits, and/or other monitoring activities (Procedure 8.2.1; Form 8.2.1; Form 8.2.1.a). The effectiveness of implementa tion is measured by number of compliance incidents reported.

4.7 Records will be kept on all the above activities according to Procedure 4.2.4.

5.0 REFERENCES

5.1 Procedure 4.2.3 Document control

Procedure 4.2.4 Record control
Procedure 6.2.2 Compliance, awareness, and training Procedure 7.2.5 Devitalization and final disposition
Procedure 8.2.1 Internal audit

Annex

- 1 Glossary
CIS website

5.2 Form 6.2.2 Record of training

Form 8.2.1 Internal audit report and checklist

Form 8.2.1.a Site inspection checklist
Form 7.4.1 Record of self

- reportingSimplot Design Protocol and Biotech Quality Management System Documents Page 36Environmental Report Page 1

8. Environmental Report

Environmental Report in Support of

Petition for Determination of Nonregulated Status for Innate TM 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 (At lantic); G11 (G); H37and H50 (H)

Prepared by Pete Clark Ph.D. and Susan Collinge Ph.D.

J.R. Simplot Company

March 1, 2013 Complementary to J.R. Simplot Company Petition JRS01 (USDA Petition 13

- 022

- 01p)

OECD Unique identifiers:

SPS

-   F10

- 7

SPS

-   F37

- 7

SPS

-   E12

- 8

SPS

-   E24

- 2

SPS

-    J3

- 4

SPS

-   J55

- 2

SPS

-   J78

- 7

SPS

-   G11

- 9

SPS

-   H37

- 9

SPS

-   H50

- 4Environmental Report Page 2 Table of Contents of Environmental Report

1. Purpose and Need

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

1.1. Purpose of Product

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

1.2. Action

................................ ................................ ................................ ................................ ............ 6

1.3. Action Area

................................ ................................ ................................ ................................ .... 6

2. Affected Environment

................................ ................................ ................................ .................... 8

2.1. Potato Products and Consumption

................................ ................................ ............................... 8

2.2. Agricultural Production of Potatoes

................................ ................................ ............................. 8

2.3. Physical Environment

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

2.4. Biological Resources

................................ ................................ ................................ .................... 18

2.5. Human Health

................................ ................................ ................................ ............................. 24

2.6. Lives tock Health Considerations

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

2.7. Socioeconomic Considerations

................................ ................................ ................................ ... 26

3. Alternatives

................................ ................................ ................................ ................................ .. 28

3.1. Alterna tive I: No Action

................................ ................................ ................................ ............... 28

3.2. Alternative II: Approval of Petition in Whole

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

3.3. Comparison of Alternatives

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

4. Environmental Consequences

................................ ................................ ................................ ..... 31

4.1. Scope of Analysis

................................ ................................ ................................ ......................... 31

4.2. A gricultural Production of Potatoes

................................ ................................ ........................... 31

4.3. Physical Environment

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

4.4. Biological Resources

................................ ................................ ................................ .................... 35

4. 5. Human Health

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

4.6. Animal Feed

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

4.7. Socioeconomic Impacts

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

5. CUMULATIVE IMPACTS

................................ ................................ ................................ ................ 42

5.1. Assumptions Used for Cumulative Impacts Discussion

................................ .............................. 42

5.2. Cumulative Impacts: Land Use

................................ ................................ ................................ .... 42

5.3. Cumulative Impacts: General Agronomic Practices

................................ ................................ .... 43

5.4. Cumulative Impacts: Organic Production Practices

................................ ................................ .... 43

5.5. Cumulative Impacts: Water Resources

................................ ................................ ....................... 43

5.6. Cumulative Impacts: Soil Quality

................................ ................................ ................................ 43

5.7. Cumulative Impacts: Air Quality

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

5.8. Cumulative Impacts: Climate Change

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

5.9. Cumulative Impacts: Animal Communities

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

5.10. Cumulative Impacts: Plant Communities, Gene Flow, and Weediness

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

5.11. Cumulative Impacts: Microorganisms

................................ ................................ .................... 45

5.12. Cumulative Impacts: Biodiversity

................................ ................................ ............................ 45

5.13. Cumulative Impacts: Consumer Health

................................ ................................ .................. 45

5.14. Cumulative Impacts: Worker Safety

................................ ................................ ....................... 46

5.15. Cumulative Impacts: Animal Feed (Livestock Health)

................................ ............................. 46

5.16. Cumulative Impacts: Domestic Economic Environment

................................ ......................... 46

5.17. Cumulative Impacts: Trade (International) Economic Environment

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

6. References

................................ ................................ ................................ ................................ ... 48Environmental Report Page 3 LIST OF TABLES

Table 1. Events and Their OECD Unique Qualifier. Table 2. Recipient Potato Material. Table 3. U.S. 2010 Potato Harvest by State. Table 4. U.S. Potato Harvests by Seasonal Group, 2009.
Table 5. Common Potato Disease and Insect Symptoms Table 6. U.S. Per Capita Potato Consumption 2012 (Pounds).
Table 7. U.S. 2010 Potato Utilization. Table 8. Summary of Potential Impacts.

LIST OF FIGURES

Figure 1. Potato Production by State: 2010. Figure 2. Potato Produ ction in the United States (proximity to wild spp.): 2011.

Acronyms and Abbreviations

APHIS Animal and Plant Health Inspection Service

ARS Agricultural Research Service (within USDA)

BRS Biotechnology Regulatory Services (within USDA

– APHIS)

CAA Clean Air Act

CEQ Council on Environmental Quality

CFR Code of Federal Regulations (United States)

CWT 100 pounds

DNA deoxyribonucleic acid

EA Environmental Assessment

EPTC S

- Ethyl dipropylthiocarbamate, a herbicide

ERS Economic Research Service (within USDA)

FAO Food and Agricultural Organization of the United Nations

GWP Global warming potential

IPD Inter

- genebank Potato Database

NASS National Agricultural Statistic Service (within USDA)

NEPA National Environmental Policy Act

NOP National Organic Program

NPC National Potato Council

NSF National Science FoundationEnvironmental Report Page 4

Acronyms and Abbreviations

OECD Organization for Economic Co

- Operation and Development

PAA Potato Association of America

PPRA Plant Pest Risk Assessment

TPS True Potato Seed

USDA US Department of Agriculture

USDHH US Department of Health and Human Services

US EPA US Environmental Protection Agency

US FWS US Fish and Wildlife Service

WPS Worker Protection StandardsEnvironmental Report Page 5

1. Purpose and Need

1.1. Purpose of Product

Simplot has developed potato events with low acrylamide potential and reduced tendency for black spot bruise to meet expected market demand. The InnateTM branded proprietary potatoes have been developed through the utilization of biotechnology transformati on methods that use primarily potato DNA (Collinge and Clark 2013). The reasons for the market demand are described below.

The FDA has not issued guidance to manufacturers, and its general advice regarding acrylamide is for consumers to adopt a diet consistent with the Dietary Guidelines for Americans (USDA USDHHS 2010). The FDA is considering issuing guidance for the industry on reduction of acrylamide levels in food products (US FDA 2009 p. 2). The introduction of potatoes with low acrylamide potential would provide potatoes that are substantially equivalent to existing varieties, except for the intended differences.

Acryla mide, a naturally

- occurring substance that forms primarily in carbohydrate

- rich food cooked to temperatures over 250 degrees Fahrenheit (involves a Maillard reaction), has been in the human diet for many thousands of years according to the U.S. Environment al Protection Agency and the U.S. Food and Drug Administration (US EPA 2010 p. 6, US FDA 2009). It is found in french fries and chips, breads and bakery products, cereals and muesli, crackers and snack food, gravies and seasoning, nuts and nut butter, cho colate, canned fruits and vegetables, coffee and other foods (US EPA 2010 p. 7, US

- FDA 2006). Because of concerns about the potential human health effects of acrylamide, there have been international efforts to reduce acrylamide levels in food since repor ts about its presence in food in 2002 (US

- FDA 2009 p. 2).

Acrylamide forms in foods primarily from a reaction between certain sugars such as glucose and fructose (reducing sugars) and asparagine (an amino acid) that are naturally present in food (US FDA 2 009 p. 2). For potatoes, mitigation measures have focused on 1) controlling levels of sugar and/or asparagine in the potatoes and 2) modifying processing and/or cooking techniques to reduce the formation of acrylamide (US FDA 2009 p. 4, Food Drink Europe 2011) . Use of food additives such as the enzyme asparaginase, which breaks down asparagine, is approved in several countries including Canada and the U.S. (Health Canada 2012 p.1). The reduction in asparagine and sugars using InnateTM technology and the resulting reduction in acrylamide upon heating will address industry needs with respect to the potential FDA guidance.

In addition, litigation in the state of California resulted in legal settlements with restaurant chains and the retail french fry and po tato chip manufacturers regarding acrylamide. The settlements required manufacturers of retail fries and potato chips to reduce the level of acrylamide in their products (State of California, Office of Attorney General 2008) as well as share any technology that would result in reduced acrylamide. Potato processors affected by these rulings in California would be motivated to adopt the low acrylamide potatoes.

Demand for the low acrylamide potatoes would also be expected from consumers who are concerned

a bout the levels of acrylamide in their food. The benefits resulting from the modifications could result in increased market share for certain varieties, such as Ranger Russet. The lower levels of reducing sugars and black spot bruise in the InnateTM Ranger Russet may increase the popularity of that variety.Environmental Report Page 6

Extensive analyses of the various events demonstrated that the achievement of the desired modifications was enabled by targeted gene silencing. Simplot found there to be reduced RNA (transcript) level s of four targeted genes in tubers, which may be associated with:

(1) 69

– 78 percent reductions in free

- asparagine; (2) Black spot bruise tolerance; and (3) Lower levels of reducing sugars (Collinge and Clark 2013).

The Ranger Russet variety has higher yield poten tial than Russet Burbank, but its market penetration is limited by its susceptibility to black spot bruising and senescence sweetening. It is anticipated that while the InnateTM potato events may enjoy significant acreage due to the potential health benefit s of reduced acrylamide and reduced black spot, no overall significant increase in potato production acreage in the United States is expected.

1.2. Action

Simplot is seeking nonregulated status for the events listed in Table 1under 7 CFR part 340. Specifica lly, Simplot requests a determination from APHIS that the 10 potato events described in the petition, and any progeny derived from these events, are granted nonregulated status and would no longer be considered regulated articles under 7 CFR Part 340 (Coll inge and Clark 2013).

Table 1 . Events and Their OECD Unique Identifiers

Event Number OECD Unique Identifier F10 (Ranger Russet) SPS

-   F10

- 7 F37 (Ranger Russet) SPS

-   F37

- 7 E12 (Russet Burbank) SPS

-   E12

- 8 E24 (Russet Burbank) SPS

-   E24

- 2 J3 (Atlantic) SPS

-    J3

- 4 J55 (Atlantic) SPS

-   J55

- 2 J78 (Atlantic) SPS

-   J78

- 7 G11 (“G” variety) SPS

-   G11

- 9 H37 (“H” variety) SPS

-   H37

- 9 H50 (“H” variety) SPS

-   H50

- 4

1.3. Action Area

Commercial potato production occurred on over one million acres in 2011 in 31 U.S. states across the continental U.S. and in Alaska (USDA NASS 2012). 1 Idaho accounts for 30% of the planted acreage, and the eight states of Idaho, Washington, North Dakota, Wisconsin, Colorado, Maine, Minnesota and Michigan account for over three

- quarters of the planted acreage (USDA NASS 2012). While production tends to be in northern states, in 2011, two southern states, Texas and Florida, each had more than 10,000 acres harvested (USDA NASS 2012).

1 In some years additional states reported small harvested acreage.Environmental Report Page 7

Except for the reduc tions in free asparagine and reducing sugars and the greater tolerance to black spot bruising, potatoes transformed by Simplot’s InnateTM technology are substantially equivalent to their

non

- transformed counterparts. Other characteristics are not affected by the transformation process. Therefore, the InnateTM potatoes would be grown in the same areas and using the same techniques as
their non

- transformed counterparts. Usage and acreage characteristics of the recipient (non

transformed) potato material are summarized in Table 2 (Collinge and Clark 2013).

Table 2 . Recipient Potato Material
Variety Usage Percent of Seed Acreage in US 1

Russet Burbank Fries 22.0 Ranger Russet Fries 6.3
Atlantic Chips 2.6

G Chips 2.0

H Chips 0.7

1 2009 data [National Potato Council (NPC) 2010 p. 63]Environmental Report Page 8

2. Affected Environment

The affected environment section provides an overview of the use and composition of potatoes, followed by a discussion of the current conditions of those aspects of the human en vironment potentially impacted by a determination of nonregulated status of events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50. Potato production occurs throughout much of the U.S., although production is concentrated in the top ten potato producin g states described below.

2.1. Potato Products and Consumption

Potatoes in the United States are grown in many states, although about half of the crop comes from Idaho and Washington. The top ten potato producing states of Idaho, Washington, Wisconsin, North Dakota, Colorado, Oregon, Maine, Minnesota, California and Michigan account for almost 88% of the United States potato crop (USDA

- NASS 2012). Most potatoes are harvested in July through October. Only about one third of US potatoes are consumed fresh. Around 60% of annual output is processed into frozen products (such as frozen fries and wedges), chips, dehydrated potato and starch, while 6% is replanted as seed potato. Americans eat, on average, approximately 50 kg of potatoes per person per year (NPC 2012).

Harvested potatoes are either used for food (~93%), feed (<1%), industrial purposes (<1%) or as “seed” for planting (5%). The type of use is partially dependent on a variety of characteristics related to tuber quality. According to the National P otato Council, approximately 50% of all tubers are used for the combination of frozen fries, potato chips, and shoestrings (julienne cut crispy snacks), whereas 11% are dehydrated and <2% are canned. An additional 28% of tubers are not processed but sold a s fresh potatoes (NPC 2010).

Raw potato waste products (peels, out of specification raw potatoes, or other non

- processed raw potato products) and processed discards (french fry, hash brown, etc.) are routinely incorporated into feed
rations at livestock feedlot operations including those owned by Simplot.

2.2. Agricultural Production of Potatoes

Land Use

U.S. 2011 potato harvests by state are summarized in Table 3 (in acres) and 2011 production by state is shown graphically in Figure 1 (in CWT).Environmental Report Page 9

Table 3. U.S. 2011 Potato Harvest by State.

State Acres of Potatoes Harvested

IDAHO

WASHINGTON

NORTH DAKOTA

WISCONSIN

COLORADO

MAINE

MINNESOTA

MICHIGAN

OREGON

CALIFORNIA

FLORIDA

NEBRASKA

TEXAS

NORTH CAROLINA

NEW YORK

MONTANA

PENNSYLVANIA

MISSOURI

ILLINOIS

VIRGINIA

KANSAS

ARIZONA

MASSACHUSETTS

MARYLAND

NEW JERSEY

OHIO

DELAWARE

ALASKA

RHODE ISLAND 319,000
160,000
77,000
62,500
58,300
54,000
47,000
44,000
39,900
36,600
35,600
19,500
18,500
16,500
16,200
11,500
7,800
7,100
6,800
5,900
5,300
3,800
2,700
2,200
1,800
1,700
1,600

720

600

Total Approximately 1,000,000

Source: USDA NASS 2012; Nevada and New Mexico not reported to protect privacyEnvironmental Report Page 10

Figure 1 . Potato Production by State, Thousands CWT: 2011.

Source: USDA NASS 2012

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 2012). In most years from 1900 to 1937, more than 3 mil lion acres were harvested, with a high of 3.9 million in 1922 (USDA NASS 2012). While acreage has declined over the years, total production has increased. Total annual U.S. production has been over 400 million CWT (one CWT = 100 pounds) every year since 1990, with a peak of 513 million CWT in 2000 (USDA NASS 2012). Per

- acre yields, which averaged approximately 401 CWT per acre in 2010 have increased eight

- fold since the early 1900s and have doubled since the early 1960s. For example, in 1901 approximatel y 2.95 million acres of potatoes were harvested, producing roughly 125 million CWT, or 42.4 CWT per acre. In 2010, the harvested acreage was a reported 1 million acres, producing about 400 million CWT, or about 401 CWT per acre (USDA NASS 2012).

Recently , the bulk of potato production in the U.S. has shifted from the East and Midwest to the Northwest. The shift has resulted from a number of factors, including improvements in the U.S. transportation system, the relative decline in consumption of fresh pot atoes coupled with advantages associated with processing potatoes in the Northwest, and changes in weather patterns (Guenthner 2010a, p. 13). Potatoes are grown in agricultural areas throughout the U.S. The largest potato

- growing region by far in
the U.S . is the Snake River Plain of southern Idaho, a major agricultural area where water is available for irrigation, and where nearly all the Idaho crop is grown (Bechinski et al. 2001, USDA NASS 2012, National Atlas 2004a). In 2010, more acres were harvested in a single Idaho county in the Snake River PlainEnvironmental Report Page 11

(61,800 acres in Bingham County) than the total in all other states except Washington and North Dakota (USDA NASS 2012). The second

- largest growing region is the Columbia Basin (another large agricultural area) in Washington and Oregon, where approximately 127,000 acres were harvested in 2010 (USDA NASS 2012, National Atlas 2004b). Other important areas (with 2010 harvested acreage in parentheses) are the Red River Valley, which lies between the northern b orders of North Dakota and Minnesota (63,000) 2 ; San Luis Valley in south central Colorado (55,000), Aroostook County in Maine (50,400), and the Central Sands region of Wisconsin (37,000) (USDA NASS 2012, Delahaut 2000, McDonald et al. 2003). The potato ev ents that are the subject of this Environmental Report (ER) may be grown in any of the U.S. potato

- growing regions.

Potatoes grown commercially are actually clones, produced vegetatively by tuber cuttings (the lateral buds or "eyes") rather than by the tr ue botanical seed (NSF 2011). These vegetative cuttings used to produce commercial crops are called “seed potatoes.” Approximately 6 percent of the annual potato crop is used as seed (USDA NASS 2011, p. 7). Certified seed potatoes are produced for the p urpose of ensuring genetic purity and the reduction of disease introduction (NPC 2010). Most seed that is sold is labeled certified seed (USDA 2000, PPA 2011b, Davidson 2010 pp. 43

- 44; Bechinski et al. 2001, p. 2). There are 16 potato seed certification a gencies in the U.S., including one in each major production state and many in other production states (NPC 2010). Seed potatoes are grown in the same areas where potatoes for commercial production are grown, although the areas of maximum seed production a re often different from the areas of maximum commercial production (e.g., Delahaut 2000, Oregon State University 2008). Much of Maine’s potato production is for seed potatoes to supply the east coast (Maine Potato Board 2001, p. 12). Major seed productio n states in 2009 in order of decreasing production were Idaho, Washington, North Dakota, Colorado, Wisconsin, Maine and Michigan (USDA NASS 2011, p. 11).

General Agronomic Practices

USDA classifies potato production by season, according to the period when the largest supplies are harvested, as summarized in Table 4. Winter, spring and summer potatoes are harvested while the vines are still green and the tubers comparatively immature. These potatoes go directly from the field
to fresh markets or into processing. Fall potatoes are usually harvested when the vines and tubers are mature. The mature potatoes are usually higher in dry matter, which makes them better for most processing. The mature fall potatoes also have tougher skins, which makes them easier to handle (Johnson 2010 p. 75). A large percentage of the fall crop is stored for processing and fresh market through the winter, spring and summer months. Many modern storage facilities are equipped with temperature, humidity, and forced

- air vent ilation control. Capacity can range from 500 tons to over 20,000 tons (Olsen 2010 p. 81).

Table 4. U.S. Potato Harvests by Seasonal Group, 2009

Seasonal Group Planted Harvested Acres
Harvested (1,000) Primary States Average Yield, CWT/acre

Winter August

December January

-

March 8.7 CA only 245

Spring December

March April

– June 73.7 CA, FL 289

2 2009 harvested acreage; 2010 not available for North Dakota.Environmental Report Page 12

Summer March

- June July

– Mid

September 44.4 11 states, all <
8,500 acres ea. 351

Fall March

- June July

- November 917.2 ID, WA, ND, WI, CO, ME, MN, MT, OR 429

Sources: USDA NASS 2011; Voss 2004; Bechinski et al. 2001 p. 2; USDA 2000, p. 1; McDonald et al. 2003, p. 1.

Cultivation

Potatoes typically require high levels of soil cultivation (Hopkins et al. 2004, p. 10). Cultivation of the soil is used for weed control, aeration, shaping beds, maintaining proper seed depth and establishing irrigation furrows (Bechinski et al. 2001, p. 2; Sieczka 2010 p. 53). Potato production is generally less
conducive to maintaining healthy soil conditions due to intensive tillage, minimal crop residues, heavy field traffic and long periods of bare soil (Hopkins 2010 p. 34). In the Northwest, potato fields are typically tilled both before and after the season (Hopkins et al. 2004 p. 9). Common practice in the Red River Valley is to plow once in the fall, till two or more times during the winter, and disc the field in the spring, just before planting (USDA 2000 p. 1). In the San Luis Valley, minimum and conventional till age practices are both used (McDonald et al. 2003 p. 2).

Cover Crops

Cover crops may be used with soil high in clay to help keep them productive (Rosen 2010a p. 32). Some growers use a fall cover crop to help prevent erosion (Sexton 2010a p 36). Planti ng a cover crop such as winter rye or leaving cover crop residues near the surface can provide good control of wind erosion in sandy soils (Rosen 2010a p. 32). Incorporation of green manure crops that are tilled into the soil prior to planting has been ef fective in reducing disease pressure and erosion (Hopkins et al. 2004 pp. 5 and 9). Growers in Florida use Sudan grass as a cover crop which is turned into the soil to provide nitrogen prior to potato planting (Mossler and Hutchison 2011 p. 5).

Crop Rota tion

Potato growers experience short

- term economic pressure to continuous

- crop potatoes, in part because they invest heavily in specialized equipment for potatoes and because potatoes typically represent the highest potential gross return per acre (Hopkin s et al. 2004 p. 11). However, continuous cropping and short rotations of potatoes with other crops increases insect, disease, and nematode pressure, decreases soil nutrient levels, and increases erosion potential (Hopkins et al. 2004, pp. 5

- 9; Delahaut 2000 p. 29; Hall et al. 2000 pp. 8 and 10; Bennett and O’Rourke 2002 pp. 3 and 16). University of Idaho research has shown a 40 CWT per acre loss in yield for each year less than four between potato crops (Hopkins et al. 2004 p. 10). The main crops grown in rotation with potato in Idaho are small grains, sugar beets, alfalfa, dry beans and corn (Hopkins et al. 2004, p. 5). These crops are highly unlikely to facilitate intermingling with harvested potato tubers. Grains are commonly rotated with potatoes i n the Red River Valley (USDA 2000 p. 1). In the San Luis Valley two

- year rotations of potatoes and malting barley are predominant (McDonald et al. 2003, p. 2). Rotation crops in Wisconsin include corn, small grains, legumes and green manure (Delahaut 2000 p. 29). Rotations of 3 to 5 years are recommended in Minnesota and Wisconsin (Bennett and O’Rourke 2002 p. 16; Delahaut 2000 p. 20). Growers in certain areas of Florida (ex. Hastings and Parrish areas) typically plant potatoes year after year without cr op rotation (David Parish, personal communication).Environmental Report Page 13

Insect Control

Insects damage crops directly and can also transmit pathogens such as viruses. While specific problem insects vary among production regions, all regions practice insect control, usually with insecticides, which is necessary to prevent unacceptable losses of quality or yield (Radcliffe 2010 p. 64). The green peach aphid, Colorado potato beetle, and wireworms are the most serious insect pests in the Northwest (Bechinski et al. 2001 p. 2).

Disease Control

The process of vegetative propagation results in unique disease control problems for potatoes. A disease present in the seed potato cutting is typically transmitted to the resulting potato plant. In addition, the cut surfaces of the seed potatoes, until they are suberized, are open wounds that provide a route of entry for pathogens (Davidson 2010 p. 38). Of the many diseases in potato (Table 5), some are more common in production, while others become issues while tubers are in storage (Bechinski et al.

2 001 p. 6). Control measures include use of fungicides, resistant cultivars, certified seed, crop rotation and other agricultural practices (Johnson et al. 2010 pp. 68

- 72).Environmental Report Page 14 Table 5. Common Potato Disease and Insect Symptoms 1
Insect or Disease Agent Sympto m Emposasca fabae (Potato Leafhopper) Leaf feeding damage Epitrix species (Flea Beetle) Shot

- holes in leaves Leptinotarsa decemlineata (Colorado Potato Beetle) Defoliation

Limonius californicus (Wireworm) Bored holes in tubers and shoots

Ostrinia nubilalis (European Corn Borer) Severe vine wilting above point of injury Bactericera (Paratrioza) cockerelli (Potato Psyllid) Yellows Phthorimaea operculella (Tuberworm) Foliar and tuber damage Various aphid spp. Leaf suckling damage

Aster Yellows MLO Purple top disease

Potato Leafroll Virus Rolling of leaves and net necrosis Potato Spindle Tuber Viroid Potato spindle tuber disease
Potato Virus A,M, X, Y Mosaic symptoms
Tobacco Rattle Virus Stem mottling

Erwinia carotovora Blackleg, aerial stem rot and tuber soft rot Corynebactium sepedonicum Bacterial ring rot

Ralstonia solanacearum Brown rot Phytophthora infestans Late blight Phytophthora erythroseptica Pink rot

Verticillium spp. Early dying

Sclerotinia sclerotiorum Sclerotinia stalk rot

Rhizoctonia solani Canker Streptomyces scabies Scab

Fusarium spp. Dry rot Pythium ultimum Water rot, shell rot, Pythium leak

Alternaria solani Early blight Botrytis cinerea Gray mold

1 This table is meant to give the reader a list of insects and diseases that may impact potatoes.

Weed Management

Weeds, which can cause substantial yield losses in potatoes due to competition for nutrients, water, and sunlight, are managed primarily through a combination of tillage and herbicides (Bechinski et al. 2001 pp. 11

- 12; Delahaut 2000 p. 3; USDA 2000 pp. 16

- 17; Hutchison 2010, p. 63), although tillage can damage plants and reduce yields (Bechinski et al. 2001 p. 12). The majority of growers also scout their fields for indication of herbicide need, adjust h erbicide use based on weed pressure, rotate chemical classes to avoid the development of resistant weeds, and choose rotational crops that compete successfully with weeds (Bechinski et al. 2001 p. 13). Examples of commonly used herbicides are metribuzin, EPTC, and metolochlor (Bechinski et al. 2001 p. 12, USDA 2000 p. 17; McDonald et el 2003 pp. 16

- 17).

Volunteer Potatoes

Tubers left in fields after harvest may sprout and grow amidst a subsequent crop, competing with the rotational crop for sunlight, water, and nutrients. Volunteer potatoes can also be hosts for diseaseEnvironmental Report Page 15

(Boydston and Williams 2005 p. 443; Eberlein et al. 1 998). Potatoes in moist soil will generally freeze and die at a soil temperature of 28 degrees Fahrenheit; in dry soil, soil temperatures must reach 25 degrees Fahrenheit before the potatoes freeze (Eberlein et al. 1998). For the most temperature

toleran t varieties, exposure to temperatures less than 26 degrees Fahrenheit for more than 72 hours is required to kill the tuber (Everman et al. 2010). Several herbicides are used for the control of volunteer potato plants (Boydston and Williams 2005 p. 443; Ev erman et al. 2010). Post

- harvest grazing and rotation to competitive crops can also help reduce volunteers (Eberlein et al. 1998). In most cases these plants will be eliminated by normal agronomic practices (OECD 1997 p. 23).

Outside the field, potato seedlings will have difficulty establishing themselves, as they cannot compete with other plants. Potato tubers can be spread during transportation and use, but generally these plants cannot establish themselves for a long period of time due to unfavorabl e environmental conditions. In general, potato is not known as a colonizer of unmanaged ecosystems. In climax vegetation it is not able to compete with other species such as grasses, trees and shrubs (OECD 1997 p. 23).

Organic Production Practices

The Na tional Organic Program

In the U.S., only products produced using specific methods and certified under the USDA National Organic Program (NOP) program definition of organic farming can be marketed and labeled as “organic” (7 CFR §205.102). The NOP require s organic growers to have distinct, defined boundaries and buffer zones to prevent unintended contact with prohibited substances or products of excluded methods from adjoining land that is not under an organic production management plan (7 CFR 205.202(c)). Organic production operations must also develop and maintain an organic production system plan approved by an accredited certifying agent. This plan enables the grower to achieve and document compliance with the National Organic Standards, including the prohibition of the use of excluded methods (7 CFR Part 205), which include a variety of methods used to genetically engineer organisms or influence their growth and development by means that are not possible under natural conditions or processes. The us e of biotechnology such as the InnateTM method is an excluded method under the National Organic Program (7 CFR § 205.2).

Organic producers must use organically grown seed if it is available (7 CFR §205.204). Several companies produce organically grown see d (e.g., High Mowing Seed Company, Abundant Life Seed Company; Dufour et al. 2009 p. 3). Organic Potato Production

In the U.S. in 2008, the most recent year for which data is available, a total of 7,989 acres of organic potatoes were harvested on 1,331 farms (averaging 6 acres per farm). USDA NASS reported organic potato production for 45 states (2010 Table 4), and the organic harvested acres represent only 0.7 percent of the total U.S. 2008 harvested potato acreage of 1,059,600 (USDA NASS 2010 p. 8). USDA NASS reported harvested acreage in 2008 (in parenthesis) for states with more than 250 harvested acres as follows: California (1,977), Colorado (1,921), Washington (1,477), Oregon (840), and Idaho (736) (USDA NASS 2010 Table 4).

Some organic potato es are grown in the same area where potatoes are produced using conventional methods. The majority of California’s organic potato production occurs in three interior agricultural valleys: San Joaquin, Antelope and Cuyama, as well as in the Klamath basin o n the Oregon border. InEnvironmental Report Page 16

the Klamath Basin, nearly all the organic potatoes are produced for the fresh market, with a very small percentage (1 percent in 2006) for chips (Miller et al. 2008 p. 13). All organic potatoes grown in
California are for the fres h market, and most are shipped to the East Coast (Miller et al. 2008 p. 11). Organic potatoes in Colorado are grown in the San Luis Valley and in Weld County northeast of Boulder. Nearly all production in Colorado is for fresh market consumption (Miller et al. 2008 p. 12). In the Columbia Basin (Washington and Oregon), potatoes are grown for both processing and fresh use. Some farms produce both organic and conventional potatoes (Miller et al. 2008 p. 12). In Idaho, organic potato production occurs pri marily in the Snake River Valley, and supplies both fresh and processing
markets.

Organic growers utilize many of the same production methods used by conventional growers for planting and harvesting, as well as for managing insects, weeds, and disease. However, organic growers do not use synthetic fertilizers or pesticides (Miller et al. 2008 pp. 12

- 37; Seaman 2011 pp. 2

- 52) but rather control weeds largely by tillage (Dufour et al. 2009 p. 9). Organic potato growers may use longer crop rotations, comp ost, compost tea and biological control for pests. Thus, organic farm plots are likely to be smaller in scale (Miller et al. 2008 pp. 12

- 37; Dufour et al. 2009 Table 1 and pp. 9

- 19).

2.3. Physical Environment

Water Resources

The majority of the potatoes produced in the U.S. are grown under irrigation, including potatoes grown in the Snake River Plain, the Columbia Basin, the San Luis Valley, and the Central Sands region of Wisconsin (Bechinski et al. 2001, Washington State Pot ato Commission 2011, Delahaut 2000, McDonald
et al. 2003, Oregon State University 2008). Approximately one

- quarter of potatoes grown in North Dakota are produced with irrigation (USDA 2000). Rainfall provides most of the moisture for potato crops in Main e; however, supplemental irrigation has been shown to result in increased yields (Sexton et
al. 2008). Agricultural production, including potatoes, can adversely impact surface water quality, primarily through sedimentation from erosion and nutrient load ing from fertilizers (US EPA 2005; US EPA 2009 pp. 11 and 12).

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 a l. 2002, p. 2138).Environmental Report Page 17

Soil Quality

Ideal soil for potato growing is deep, soft, and well

- drained; however, potatoes can be grown on a wide variety of soil types and pH values. Soil type is less important under irrigation (which is how most potatoes in th e U.S. are grown) because water can be applied as needed. Cover crops, timely tillage, and appropriate crop rotation are important for soils high in clay. Soils high in organic matter such as peat or muck, when adequately drained, can also produce high q uality potatoes, particularly for the fresh market. Sandy soils can also produce high

- quality potatoes, but wind erosion can pose a problem (Rosen 2010a, p. 32).

The relatively high tillage requirements of a potato crop, coupled with the small amount of post

- crop plant material, can contribute to higher erosion potential. Growing a cover crop and utilizing the subsequent crop plant material can provide protection against erosion (Rosen 2010a, p. 32; Hopkins 2010 p. 34). Potential for soil erosion is re lated to cultural practices and soil types and not to the specific varieties grown.

Air Quality

Air emissions associated with crop agriculture include vehicle emissions, fugitive dust (from disturbance of bare soil from wind or farming activities), and e missions associated with applications such as fertilizer and pesticides. In some areas, prescribed burning is practiced and results in higher emissions levels (US EPA 2011b, p. 3).

The Clean Air Act (CAA) requires the US EPA to identify pollutants that may endanger public health or welfare. Under the CAA, the US EPA establishes standards for each pollutant for which air quality criteria have been issued (National Ambient Air Quality Standards). These pollutants currently include ozone, carbon monoxide, particulate matter, nitrogen dioxide, sulfur dioxide, and lead (40 CFR Part 50). Each state is required to develop and implement plans (State Implementation Plans) to demonstrate how the standards will be met within the state. Areas with air pollution co ncentrations that exceed one or more of the standards that the US EPA has set for these pollutants are referred to as non

- attainment areas.

Non

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

specific within each State Implementation Plan (US EPA 2011b, p. 3). Regulation of agricultural sources within a State Implementation Plan does not appear to be typical. For example, based on a review of the available p lans in Idaho, achievement of air quality standards is focused on managing residential wood burning, vehicle emissions, and facilities such as factories and processing plants (US EPA 2011c, pp. 1

- 9).

US EPA regulates emissions from mobile sources throug h such mechanisms as reformulated gasoline and automobile pollution control devices (US EPA 2011b). Stricter requirements, such as vapor recovery nozzles on gas pumps, may apply in non

- attainment areas.

Climate Change

Greenhouse Gas Emissions from AgricultureEnvironmental Report Page 18

Each year the US EPA prepares an inventory of greenhouse gas emissions for the U.S. (US EPA 2012, p. iii). Greenhouse gases vary in their global warming potential (GWP), and the US EPA converts all gases to carbon dioxide (CO2) equivalents. For the three greenhouse gases most associated with agriculture, GWPs are as follows: CO2 = 1, methane (CH4) = 21, and nitrous oxide (N2O) = 310 (US EPA 2012, p. ES

3). The US EPA classifies different sources by sector, with the energy sector being the l argest contributor of greenhouse gas emissions (US EPA 2012 pp. ES

- 11 and ES

- 12). The agriculture sector, as defined by US EPA, represented 6.3 percent of total greenhouse gas emissions for the U.S. in 2010 (US EPA 2012 p. ES

- 13). However, this does not include CO2 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 CO2 and NO2 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 N2O and CH4. The relative percent contribution to total CO2 equivalent emissions of the various agricultural sources in 2010 was as follows: agricultural soil management (fertilizer application and other cropping practices that contribute N2O), 49 percent; enteric fermentation (primarily methane emissions from cattle), 33 percent; manure management, 16
percent; and rice cultivation, two percent. Emissions from field burning of agricultural residues, the remaining category, were less than 0.1 percent of the total (US EPA 2012, p. 6

- 1).

2.4. Biological Resources

Animal Communities

Potatoes are grown throughout the U.S., and therefore there is a wide range of animal communities that might be found in potato fields and surrounding areas. This discussion focuses on the types of animal communities that may be affected by potato farming.

Animals within Agricultu ral Fields

Animals generally need food, shelter, and open bodies of water for survival. Of these primary needs, cropland may provide food and/or shelter for some animals; however, in a potato field the animals seeking to consume the potato plant or tuber s are in direct competition with the grower whose livelihood depends on harvesting as large a yield as possible from his fields. Many animals, including birds and some invertebrates, are not detrimental to yields and may be beneficial to the grower by

pro viding pest control.

Animals Outside of Agricultural Fields

Animals living outside but near agricultural fields may be impacted by introduced materials from the fields. These releases could include pesticides (which are regulated by US EPA) into air and water, and soil particles, which may be released into air or water. Animal communities most likely to be impacted while living near agricultural fields are aquatic species affected by sedimentation and turbidity resulting
from erosion.

Plant Commun ities, Gene Flow, and Weediness

In general, all plants growing within an agricultural crop field that are not the intended species are weeds, and need to be controlled in order to reduce competition with crops for survival. WeedEnvironmental Report Page 19

management is discussed in Section 2.2, Agricultural Production of Potatoes: General Agronomic

Practices.

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

- up areas. As discussed in Section 2.2, most commercial potatoes are grown in large agricultural areas, such as the Snake River Valley in Idaho. Thus, other crops would most frequently make up the surrounding vegetation, although some fields would be bordered by no n

- crop vegetation. 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 potential 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 by sedimentation resulting from erosion, or by
nutrients leached fro m fertilizers.

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, otherwis e the two plants would not be classified as different species. Interbreeding can occur to a limited extent between some species under some circumstances. Among the many factors that must be present for hybridization to occur between two species are these: 1) the species must occur in the same area and habitat, 2) the flowering periods of the species involved must overlap, and 3) appropriate pollinating factors must be present (OECD 1997 p. 21).

This section summarizes the Solanaceae family, and then discusses in detail the two wild potato species that are found in the southwestern U.S. It ends with an assessment of the potential for gene flow between native and cultivated potatoes in the U.S.

Potato Characteristics

Hybridization v ia pollen transfer is not possible with the Russet Burbank, the most commonly grown potato, as it is infertile (NSF 2011, PAA 2009a, Collinge and Clark 2013). Hybridization via pollen transfer is also not possible with the “H” variety as it is infertile ( Collinge and Clark 2013). Of the fertile varieties (including Ranger Russet, Atlantic and “G”), approximately 80 to 100 percent of true seed produced is
derived from self

- pollination (Plaisted 1980 p. 491).

Cross

- pollination in potatoes is typically me diated by certain insects including bumblebees ( Bombus impatiens ) that do not travel much more than 2 miles (OECD 1997 p. 17). Other bee species such as honey bees ( Apis mellifera ) are not pollinators of potatoes since potato flowers do not contain ample

n ectar (OECD 1997 p. 17). Pollination by wind is apparently insignificant (OECD 1997 p. 17). Field evaluations in New Zealand, the United Kingdom, and Sweden demonstrated through genetic testing that outcrossing was not detected when the receiving potato plants were separated by a minimum of 20 meters (65.6 feet) from genetically modified potato plants (Connor and Dale 1996 p. 505

- 506).

Solanaceae Family

The Solanaceae family contains several well

- known cultivated crops such as tomato ( Solanum lycopersi cum also referred to as Lycopersicon esculentum ), eggplant ( Solanum melogena ), tobacco ( Nicotiana tabacum ), pepper ( Capsicum annuum ), and potato ( Solanum tuberosum ) (OECD 1997 p. 12). Within the genus Solanum , over a thousand species have been recognized. The genus Solanum is dividedEnvironmental Report Page 20

into several subsections, of which the subsection potatoe contains all tuber

- bearing potatoes. The
subsection potatoe is divided into series, of which tuberosa is relevant to this document. Within the

series tuberosa approximately 54 species of wild and cultivated potatoes are known, with one of these being S. tuberosum . (OECD 1997, p. 12).

S. tuberosum is divided into two subspecies: tuberosum and andigena . The subspecies tuber osum is the cultivated potato widely in use as a crop plant in North America and Europe. The subspecies andigena is also a cultivated species, but cultivation is restricted to Central and South America (OECD 1997, p. 12).

Wild Potatoes in the U.S.

This discussion is based on data in the U.S. Potato Genebank and on a monogram published by the American Society of Plant Taxonomists entitled Wild Potatoes ( Solanum section Petota; Solanaceae ) of North and Central America (Spooner et al. 2004). The USDA main tains the US Potato Genebank and participates in the Association of Potato Inter

- genebank Collaborators (APIC), which has produced a global inventory of wild potato genetic resources available on the internet, the Inter

- genebank Potato Database (IPD), whic h includes the U.S. Potato Genebank records. Many of the IPD records from the U.S. were obtained by John Bamberg and associates (including Spooner) during a decade of collecting wild potatoes in the Southwest U.S. (Bamberg et al. 2003) 3

The only two wi ld potato species that grow within the borders of the USA and for which specimens exist in genebanks include the tetraploid species . S. fendleri (recently reclassified as S. stoloniferum ; however, some sources including the IPD still use the S. fendleri de signation) and the diploid species S. jamesii (Bamberg et al. 2003; IPD 2011; Bamberg and del Rio 2011a, p. 1444; Bamberg and del Rio 2011b; and Spooner et al. 2004 pp. 33 and 88). 4 Through more than 10 years of field work and assessments of existing reco rds, Bamberg et al. (2003) and Spooner et al. (2004) established the presence of only these two species in the U.S. These researchers also attempted to verify previously recorded locations and through this process, updated the maps of current known locati ons of these species, providing latitude and longitude locations for each documented population (Bamberg et al. 2003, Figure 2).

3 By comparison to the IPD and Spooner et al. 2004, the USDA Plant Database is much more general; is based mostly on literature sources, some of which are more than 50 years old; and has not yet been updated with the more recent information obtained by researchers.

4 Three other species were previous ly recorded as being present in the U.S.(see discussion in Bamberg et
al

. 2003, pp. 160

- 161). The USDA Plant Database still includes the other three species.Environmental Report Page 21

Figure 2 . Potato Production in the United States. County Information is for states with wild potato populations ( Hijmans and Spooner, 2001)

There are approximately 160 records in the IPD for the U.S.; approximately half of the wild species are S. fendleri and the other half are S. jamesii (IPD 2011). Ninety percent of these records are from Ne w Mexico and Arizona and the rest are from Colorado, Utah, and Texas (IPD 2011). All of the records for S. fendleri are from New Mexico and Arizona, except two found in western Texas (IPD 2011). Spooner et
al. report that the northernmost extent of wild potatoes ( S. jamesii only) is 38 degrees north latitude (2004, pp. 1 and 2), which is one degree north of the southern border of Utah and Colorado, which lies at 37 degrees north latitude. The northernmost extent of S. fendleri ( S. stoloniferum ) is approx imately 35 degrees north latitude (Spooner et al. 2004, Figure 35).

Bamberg et al. noted that “during their collection expeditions, flowering and fruiting were not commonly observed, and most of the plants appeared to be tuberlings, suggesting that reprod uction is usually clonal” (Bamberg et al. 2003, p. 167). However, later Bamberg and del Rio reported that S. fendleri “produce abundant seed from selfing and have been shown by DNA markers to be very homogenous within populations” (Bamberg and del Rio 201 1a p. 1444).

Often the researchers were searching for previous collection sites, which were apparently very difficult to find. Spooner et al. reported: “Wild potatoes can be very difficult to locate, and two or more days of intensive searches, in areas where potatoes are documented to occur, often pass without locating them (2004, p. 26). As Bamberg et al. noted, the wild potatoes “may exist as single colonies in vast areas”Environmental Report Page 22

(2003 p. 166), and are found in mountainous regions at elevations over 1,500 meters (approximately 5,000 feet) (Bamberg et al. 2010, Del Rio et al. 2001, Bamberg et al. 2003).

All Texas records in the IPD database are from the far western part of the state in El Paso, Culbertson, and Jeff Davis Counties, where potatoes are not grown commercially. The two S. fendleri and one of the S. jamesii records are from the Davis Mountains and one of the three S. jamesii entries is fro m Guadalupe National Park (IPD 2011 p. 5; National Atlas 2004d; USDA NASS 2012; Hall et al. 2000 p. 1). Based on mapped locations, the current S. fendleri records for Arizona are all from the southeastern part of the state, while the S. jamesii records ar e primarily from the northeastern half of the state (when divided diagonally) (Bamberg et al. 2003, p. 165; IPD 2011). USDA reports recent county level data for potato production only for Maricopa County, Arizona, which is in the southwestern part of the state; other potato production does exist but is not large enough in scale to be reported at the county level (USDA NASS 2012). USDA reports potato production data for 2007 by county for New Mexico. Only one county had more than 12 acres of harvested pot atoes, McKinley County in northwestern New Mexico. All mapped S. fendleri records are in the southern part of the state; the single site that is not in the south is over 100 miles from McKinley County (Bamberg et al. 2003, p. 165; Spooner et al. 2004, Figure 35). S jamesii sites are scattered through most parts of the state (Spooner et al. 2004, Figure 7).

The Colorado records in the IPD database are from mountainous locations very near the New Mexico border. Spooner et al. reported that “reco rds of S. jamesii from natural habitats in in Colorado are limited to the extreme southwestern and southeastern parts of the state” (2004 p. 36). The San Luis Valley, a major potato production area, lies between the mountainous regions where the wild pota toes were found (USDA NASS 2012, Bamberg et al. 2003 p. 165, National Atlas 2004c; Spooner et al. 2004, Figure 7).

While there appears to be minimal, if any, overlap geographically between cultivated and wild potatoes in the U.S., there is a possibility that a few wild potato plants may be growing near potato fields (Love 1994 p. 652). Spooner et al. describe S. jamesii habitat in the U.S. as follows: “Among boulders on hillsides, sandy alluvial stream bottoms, in gravel along trails or roadways, rich or ganic soil of alluvial valleys, sandy fallow fields, grasslands, juniper

- pinyon scrub deserts, oak thicket, coniferous and deciduous forests” at elevations between 1370 and 2870 meters (4,500 to 9,400 feet). They describe S. stoloniferum ( S. fendleri ) hab itat similarly: “Among boulders on steep hillsides, sandy alluvial stream bottoms, in gravel along trails or roadways, in thick leaf mulch under trees, at edges of cultivated or fallow fields, along fencerows and railways, in organic moist soil to dry sand y soils, in grasslands, juniper

pinion scrub, desert tropical deciduous forests, and pine, fir, juniper and oak forests” at elevations between 1440 and 3400 meters (4,700 to 11,200 feet). Hybridization Potential

Based on conversations with Bamberg, Love ( 1994) reported that no one has ever reported finding hybrids between native and cultivated potatoes in the U.S., although gene transfer has been accomplished using special laboratory techniques (Love 1994 p. 653). Love concluded that, based on the
barrier s that exist, including geographic isolation (as described above), endosperm imbalances, and multiple ploidy levels, natural hybridization is “highly unlikely” and introgression (cross hybridization over multiple generations) is “impossible or at least hig hly improbable” (Love 1994 p. 647) without human intervention. More recently, US EPA has concluded that, based on its review of the scientific literature, successful gene introgression between native and cultivated potatoes in the U.S. “is virtually
exclu ded due to constraints of geographical isolation and other barriers to natural hybridization”. These barriers include incompatible (unequal) endosperm balance numbers that lead to endosperm failure andEnvironmental Report Page 23

embryo abortion, multiple ploidy levels, and incompat ible mechanisms that do not express reciprocal genes to allow fertilization to proceed. No natural hybrids have been observed between these species and cultivated potatoes in the U.S. (US EPA 2011d, pp. 9 and 10).

Threatened and Endangered Species

The re are currently three plants in the genus Solanum on the U.S. Fish and Wildlife Service (US FWS) list of threatened or endangered plant species: Erubia ( S. drymophilum ), found only in Puerto Rico; and popolo ku mai ( S. incompletum ) and Aiakeakua popolo ( S . sandwicense ), both found only in Hawaii (US FWS 2011, p. 47). Based on the evaluation of wild potatoes presented above, these species would not interbreed with cultivated potatoes; additionally, potatoes are not commercially grown in these areas.

Mic roorganisms

Land used for growing crops supports a rich and complex community of below ground microorganisms. The interactions among the below ground community, plant root structure, and organic residues in the
soil are critical for maintenance of a vari ety of dynamic soil ecological processes, including the decomposition of organic material, nutrient cycling, and release, and maintenance of soil structure and composition. Growth of desirable microorganisms is facilitated by the presence of organic mate rial and appropriate soil pH (Rosen 2010b, p. 36, Sexton 2010b, p. 37). Pathogenic microorganisms, primarily associated with disease, are discussed in Section 2.2, Agricultural Production of Potatoes : General Agronomic Practices

.Environmental Report Page 24

Biodiversity

General Biodiversity

Biodiversity refers to all species of plants, animals, and microorganisms existing and interacting within an ecosystem (Altieri 1999 p. 19). By intent, modern agricultural ecosystems have low plant diversity compared to the native systems t hey have replaced; on any given field, it is the grower’s goal to cultivate one plant to the exclusion of others. While traditional cropping systems have higher plant diversity than modern systems (Altieri 1999 p. 20), they usually have lower productivity . For example, as discussed in Section 2.1, per

- acre potato yields have increased 8

- fold since the 1900s when traditional cropping systems were used. While the in

- field biodiversity of modern farming has declined, the increases in productivity have suppo rted a growing population without the need to expand area devoted to farming, thus allowing the preservation of biodiversity on other lands. In 2006, the most recent year for which data is available, the total agricultural land used for crops in the U.S. was 330
million acres

- the same as it was in 1910, the first year USDA began tracking

- while at the same time the U.S. population increased from 92 million to 298 million (USDA ERS 2007, US Census Bureau 2010, US Census Bureau 2011).

Because potatoes are grown across the country (from Florida to Alaska) there is a large diversity of plants and animals that inhabit the areas surrounding the potato fields.

Potato Biodiversity

There is substantial genetic diversity among wild potato species, and this diversity can be used to improve cultivated potatoes. Approximately 200 species of wild potatoes have been identified, and all of them are in the Americas (Hijmans and Spooner 2001 p. 2103, FAO 2008 p. 14). The greatest biodiversity among the species of wild potato is found in the Andes; a total of 196 species have been identified in Peru, Bolivia, Mexico, and Argentina, with 93 in Peru alone (Hijmans and Spooner 2001 p. 2103). Th ese wild species “represent a veritable treasure chest of genetic diversity for potentially useful traits that may someday be bred into new varieties” (USDA ARS 2011).

2.5. Human Health

Consumer Health

The potato is the world’s number one non

- grain food commodity (FAO 2008 p. 3). Potatoes are rich in carbohydrates, making them a good source of energy. They have the highest protein content (around 2.1 percent on a fresh weight basis) in the family of root and tuber crops, and protein of a fairly high qual ity, with an amino

- acid pattern that is well matched to human requirements. They are also very rich in vitamin C (a single, medium

- sized potato contains about half the recommended daily intake) and

contain one

- fifth of the recommended daily value of potass ium (FAO 2008 p. 4).

U.S. per capita potato consumption is summarized in Table 6 (NPC 2012).Environmental Report Page 25

Table 6. U.S. Per Capita Potato Consumption 2012 (Pounds)

Fresh
Market Processing All

Potatoes Canned Frozen Chips Dehydrated Total Processing

35 1 50 15 12 78 112

1 NPC 2012; totals may not add due to rounding.

Toxins and Allergens in Potato

Acrylamide forms in foods primarily during the Maillard Reaction, 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 (US FDA 2009 p. 2).

Glycoalkaloids are well

- known naturally

- occurring toxicants that are present in all potatoes. For food safety purposes, an upper limit for glycoalkaloid content of 20 milligrams per 100 grams of potato is generally accepted (Sinden 1987 p. 41).

Patatin is a type of protein that makes up about 40 percent of the soluble protein in potatoes (Mignery
et al. 1988 p. 27). Allergic reactions to potatoes are considered to be very uncommon and have been reported for children only (De Swert et al. 2007 p. 750), w ith patatin identified as the major allergen involved in this reaction (De Swert et al. 2007 p. 755). Because potato protein naturally contains a relatively large proportion of patatin, those who are allergic to patatin wound need to avoid eating
potatoes.

Worker Safety

Farm workers are exposed to a number of work place hazards, including those associated with farm equipment and pesticide use. The US EPA’s Worker Protection Standard (WPS; 40 CFR Part 170) requires actions to reduce the risk of pesticide poisonings and injuries among agricultural workers and pesticide handlers. The WPS contains requirements for pesticide safety training, notification of pesticide applications, use of personal protective equipment, restricted entry intervals following pest icide application, decontamination supplies and emergency medical assistance.

2.6. Livestock Health Considerations

Animal Feed (Livestock Health)

USDA reports that only a small part of the potato crop (593,000 CWT (29,560 tons) in 2010) was used for livestock feed (see Table 7). This tends to include only potatoes that are sold specifically as livestock feed, and not the potato waste that is used f or livestock feed; Simplot uses both raw and processed potato waste products as livestock feed on its company

- owned feedlots in the Northwest. The potato waste consists of peels and potato material that does not meet certain specifications. At Simplot’s Grandview, Idaho feedlot alone, approximately 15,000 tons of processed potato waste and 60,000 tons of raw potato waste are integrated into livestock feed annually. The typical feed ration used for cattleEnvironmental Report Page 26

finishing includes approximately 5 to 8 percent ra w potato waste and 3 to 6 percent processed potato waste (Collinge and Clark 2013).

Potato foliage is not provided as feed to livestock. Flowers, sprouts and foliage are particularly rich in glycoalkaloids, and it is recognized that these parts of the potato plant are potentially poisonous for livestock (Sinden 1987, p. 41).

2.7. Socioeconomic Considerations

Domestic Economic Environment

The total value of U.S. potato production in 2009 was $3.5 billion, the average yield was 414 CWT/acre and the averag e price received was $8.25/CWT (USDA NASS 2011, p. 16).

Unlike true commodity crops such as corn and soybeans, most potatoes are grown for a particular market. As shown in Table 2, the Russet Burbank and Ranger Russet are used for fries and the Atlanti c, “H”, and “G” varieties are used for chips. Atlantic is the standard for making potato chips from the field or from very short storage (PAA 2009b). Any of these can also be sold on the fresh market. On the fresh market, Russet Burbank potatoes are the standard for baking (PAA 2009a), and Ranger Russet potatoes
are also well

- suited for baking (Pavek et al. 1992 p. 483). Other varieties are used for canning and are
well

- suited for boiling. There are thousands of potato varieties, some intended for very small markets, one example being the Vitelotte, which has blue skin and purple flesh (Food and Agriculture Organization of the United Nations (FAO) 2008 p. 21).

U.S. 2010 potato utilization is summarized in Table 7. Specific varieties are not grown for the dehydration market or for livestock feed, rather, food

- grade potatoes considered unsuitable for their intended fresh or other processing markets are usually used for dehydration and feed (Guenthner 2010b, p. 17). Because potato sales for livestock fee d usually receive the lowest price, potatoes are not sold for livestock feed if other uses are available (Guenthner 2010d, p. 16).Environmental Report Page 27

Table 7. U.S. 2010 Potato Utilization.

Utilization Item CWT (1,000)

Sales

– fresh and processing Table stock (fresh) 107,407

Processing Chips and shoestrings 54,692 Dehydrated (except starch and flour) 34,130
Frozen french fries 135,557 Other frozen products 13,360 Canned products 1,658 Other canned products (hash, stews, soup) 689 Starch, flour and other 6,356

Total processing 246,442

Other sales
Livestock feed 593
Seed 20,621

Non

- sale Seed used on farms where grown 3,002
Household and feed use on farms where grown 1,218 Shrinkage and loss 24,990

Total Production 404,273

Source: USDA NASS 2011

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

- farm storage and fumigation, was $2,811 (Patterson 2011, p. 29). In the same year, the gross return per acre averaged $4,107.50, resulting in a net return of $1,297. When that same variety was grown in South

- central Idaho, the 2011 per acre operating cost, including on

- farm storage and fumigation, was $2,560 (Patterson 2011, p. 35), and the gross return per acre averaged $3681.25, resulting in a net return of $1,121. The largest operating cost items are fertilizer, chemicals and pesticides, storage and seed potatoes (Patterson 2011, p. 29). Sales value per acre is normally highest for the winter crop and lowest for fall potatoes, b ut varies widely among the producing states. Prices for fresh potatoes are usually higher than prices for processing potatoes due to crop

- quality standards. Domestic potato prices may vary not only in response to changes in weather, yield or demand, but al so 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 result (USDA ERS 2012a, p.3).

Most fresh market potatoes in North America can be classified as russets, reds, yellows or whites based on skin color. Most eastern potato growers are also involved in packing; in the wes t, the businesses areEnvironmental Report Page 28

usually separate. Recently, western growers have entered the packing business, often in partnerships or cooperatives with other growers (Guenthner 2010c, p. 18). Fresh potatoes may be shipped in refrigerated rail cars or trucks to m aintain a high standard of quality.

Typically, frozen and dehydration processing occurs near potato production areas whereas the chipping industry is more spread out. The fragility of chips and the high cost of shipping low

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

- grade potatoes from fresh packers for processing (Guenthner 2010b, p. 17).

Organic Potatoes

Organic potato production is discussed in Section 2.2, Agricultural Productio n of Potatoes: Organic
Production Practices. A total of 2.3 million CWT of organic potatoes were harvested in 2007, with a total sales value of $30 million ($13.19/CWT) (USDA NASS 2010 Table 4). This price is substantially higher than the overall average potato price, and probably reflects both the organic premium and the fact that most organic potatoes are sold fresh. Organic growers generally receive a significant price premium when they can sell their potatoes as organic (Dufour et al. 2009 p. 27); ho wever, that market is not always available (Esplin 2009 p. 1). The organic potato market is not highly structured (Dufour et al. 2009 p. 25). At least one manufacturer produces organic potato chips (Kettle Foods 2009).

Trade Economic Environment

In 201 1, U.S. exports of all potatoes and potato products totaled $1.5 billion

— up from $1.3 billion in 2010 (USDA ERS 2012b, p. 3). Demand from Canada, Mexico and Asia is driving growth in exports. For 2011, the U.S. had a $388 million trade surplus with respe ct to all potato products, with the largest net imports from Canada. Japan is the largest market for U.S. exports of frozen potatoes while Canada is the largest US export market for chips and fresh potatoes. Frozen french fries account for more than half of the value of U.S. potato product exports (USDA ERS 2012c, p. 19).

3. Alternatives

This section analyzes the potential environmental consequences of a determination of nonregulated status of events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50. To respond favorably to a petition for nonregulated status, APHIS must determine that events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 are unlikely to be a plant pest risk. If based on its PPRA, APHIS concludes that events E12, E24,
F10, F37, J3, J5 5, J78, G11, H37, and H50 are unlikely to pose a plant pest risk, APHIS must determine that events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 are no longer subject to 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act.

Two al ternatives are evaluated in this ER: Alternative I as the no action alternative; and Alternative II as the determination of nonregulated status. APHIS will assess the potential for environmental impacts for each alternative in the Environmental Consequence s section.

3.1. Alternative I: No ActionEnvironmental Report Page 29

Under Alternative I: No Action, APHIS would deny the petition. Events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 addressed by this ER and progeny derived from them would continue to be regulated
articles unde r the regulations specified in section 7 CFR Part 340. Permits issued or notifications acknowledged by APHIS would still be required for introductions of the potato events addressed in this ER and measures to ensure physical and reproductive confinement wo uld continue to be implemented. APHIS might choose this alternative if there were insufficient evidence to demonstrate the lack of plant pest risk from the unconfined cultivation of potatoes derived from events E12, E24, F10, F37, J3, J55, J78, G11, H37, a nd H50 addressed in this ER.

3.2. Alternative II: Approval of Petition in Whole

Under this alternative, events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 addressed in this ER would no longer be regulated articles under 7 CFR Part 340. Permits iss ued or notifications acknowledged by APHIS would no longer be required for the introduction and cultivation of these potatoes. This alternative meets the purpose and need to respond appropriately to a petition for nonregulated status based on the requirem ents in 7 CFR Part 340 and the agency’s authority under the plant pest provisions of the Plant Protection Act. When the agency has concluded that events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 are unlikely to pose a plant pest risk, a determina tion of nonregulated status of events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 will be a response that is consistent with the plant pest provisions of the Plant Protection Act, the regulations codified in 7 CFR Part 340, and the biotechnology re gulatory policies of the Coordinated Framework.

Under this alternative, potato growers and processers may have future access to events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 and progeny derived from these events if the developer decides to

co mmercialize events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50.

3.3. Comparison of Alternatives

Table 8 presents a summary of the potential impacts associated with selection of either of the alternatives evaluated in this ER. The impact assessment is p resented in Section 4 of this ER.

Table 8. Summary of potential impacts.

Attribute Alternative I: No Action Alternative II: Nonregulated Agricultural Production Considerations

Land Use Unchanged Unchanged General Agronomic Practices Unchanged Unchanged Organic Production Practices Unchanged Unchanged

Environmental Considerations

Water Resources Unchanged Unchanged Soil Quality Unchanged Unchanged Air Quality Unchanged Unchanged Climate Change Unchanged Unchanged

Animal Communities Unchanged Unchanged Plant Communities, Gene Flow,
and Weediness Unchanged Unchanged

Microorganisms Unchanged UnchangedEnvironmental Report Page 30

Biodiversity Unchanged Unchanged

Human Health Considerations

Consumer Health Unchanged Unchanged Worker Safety Unchanged Unchanged

Livestock Health Considerations Animal Feed (Livestock Health) Unchanged Unchanged

Socioeconomic Considerations

Domestic Economic

Environment Unchanged Unchanged

Trade Economic Environment Unchanged UnchangedEnvironmental Report Page 31

4. Environmental Consequences

This analysis of potential environmental consequences addresses the potential impact to the human environment from the alternatives analyzed in this ER, namely taking no action and a determination by the agency that events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 do not pose a plant pest risk and therefore should no longer be regulated under 7 CFR Part 340. Potential environmental impacts from the No Action Alternative (Alternative I) and the Preferred Action Alternative (Alternative II) are
described in this section. A cumulative effects analysis is presented for each potentially affected environmental concern. Certain aspects of these events and the resultant products would be of no concern for either alternative, but could be positive for the enviro nment due to increased processing efficiency, effectively increasing yield per acre by reducing culls (out of specification products) due to the presence of black spot bruise.

4.1. Scope of Analysis

Potential environmental impacts from the No Action Alterna tive (Alternative I) and Determination of Nonregulated Status (Alternative II) of events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 are described throughout this section. An impact would be any change, positive or negative, from the existing basel ine conditions of the affected environment (see Section 2 for overview information). Impacts may be categorized as direct, indirect, or cumulative. A direct impact is an effect that results solely from a proposed action and occurs at the same time and plac e, e.g., soil disturbance, air emissions, and water use. An indirect impact may be an effect that is related to but removed from a proposed action being later in time or farther removed in distance but still reasonably foreseeable, e.g.,
increased field ti llage operations negatively impacting water resources through topsoil runoff.

A cumulative effects analysis is also included for each environmental issue. A cumulative impact may be an effect to the environment which results from the incremental impact of the action when added to other past, present and reasonably foreseeable future actions. An example would be transforming potato plants with other GE constructs that are no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act. If there are no direct or indirect impacts, there can be no cumulative impacts.

4.2. Agricultural Production of Potatoes

Land Use

As discussed in Section 2.2, Agricultural Production of Potatoes: Land Use, potato yields have increased dramatically over the years, while acreage devoted to cultivation has declined. 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 2012). Per

- acre yields, which averaged 397 CWT per acre in 2011 and 401 CWT per acre in 2010 have increased eight

- fold since the early 1900s and have doubled since the early 1960s (USDA NASS 2012).

Alternative I: No Action . USDA projects the potato supply will increase by 4.6% between 2012 and 2021 (USDA 2012 p. 76). Based upon the historical trends in productivity, this increase in supply is unlikely to result in an increase in potato acreage. The refore, under Alternative I: No Action, agricultural land used for potato production is expected to remain essentially as it is now.Environmental Report Page 32

Alternative II: Approval of Petition in Whole . If APHIS chooses this alternative, some of the events could
become commer cially 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 InnateTM varieties instead of their conventional counterparts. With t he 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 increased 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 (Collinge and Clark 2013), the agronomic characteristics of the ten events are essentia lly the same as their conventional counterparts, and therefore would be grown in the same way as their conventional counterparts. The ten events do not possess traits that would allow them to be grown in areas other
than those where their conventional cou nterparts are grown.

Therefore, no difference from Alternative I: No Action in terms of land use would be expected if the petition was approved in whole.

General Agronomic Practices

Agronomic practices and major production areas are discussed in Se ction 2.2, Agricultural Production of Potatoes: General Agronomic Practices. Potatoes are grown across the contiguous U.S. and Alaska, with major production areas in Idaho, Washington, North Dakota, Minnesota, Wisconsin, Colorado and Maine. The majority of the crop is grown using irrigation. Potato production is input

- intensive, and large

- scale production requires specialized equipment.

Alternative I: No Action . If APHIS chooses Alternative I: No Action, general production practices would be expected t o continue as they are now.

Alternative II: Approval of Petition in Whole . The agronomic evaluation of the ten events is summarized in Section 7 of the petition, with details provided in Appendix 6; analysis of disease susceptibility is presented in pe tition Appendix 8 (Collinge and Clark 2013). Since all ten events are intended for fry and chip production, agronomic evaluations were conducted in geographically distinct sites that represent most of the main production areas for potatoes destined for fr y and chip production in the U.S. (Collinge and Clark 2013). The agronomic practices and pest control measures employed
were location

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

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

year trials: time to emergence, vigor, leaf size, leaf curl, vine maturity, disease susceptibility, insect damage, yield and specific gravity. These trials indicated that no changes to current agronomic practices will be needed to grow t he potatoes, thus the incorporated traits are not expected to affect agronomic practices. All events considered for deregulation were selected to exhibit comparable phenotypic characteristics to the control varieties when grown using standard industry pra ctices. 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 process es were not affected by the incorporated traits.Environmental Report Page 33

In summary, based on the analysis presented in the petition, no impacts on agronomic practices are expected. If APHIS were to choose Alternative II: Approve the Petition in Whole, there would be no
expect ed differences for general production practices than if Alternative I: No Action was chosen.

Organic Production Practices

Organic potato production is discussed in Section 2.2, Agricultural Production of Potatoes: Organic
Production Practices . The majo r production states are California, Colorado and Washington. 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 gen eral increasing trend ranging from a low of 4,335 acres in 1997 to a high of 11,664 in 2007 (USDA ERS 2009).

Alternative I: If APHIS chooses the No Action Alternative, organic production is expected to continue much the same as it has in the recent pas t. Many unpredictable variables may affect trends, including demand for both fresh and processed organic potatoes, overseas competition and production costs.

Alternative II: Potato variety selection and breeding practices are similar between organic and conventional potato production, as commercial potatoes are predominantly grown from seed potatoes. Risks to organic growers would be most likely to occur with accidental mixing of planting material or of potatoes in farming, transportation, or processi ng channels. These risks are the same as those that organic growers already experience when keeping their organically grown potatoes separate from potatoes grown with conventional methods. Because potatoes are clonally propagated, the risk of affecting se ed supplies through cross

- pollination is negligible. Organic farmers routinely plant organic seed potato material and any incidence of cross

- pollination in production fields will not affect the harvested potatoes.

In summary, if APHIS were to choose Alternative II: Approval of the Petition in Whole, organic growers would not be expected to modify their practices in any way as a result, thus, no impacts to organic potato production would be expected.

4.3. Physical Envir

onment

Water Resources

Water resources are discussed in Section 2.3, Physical Environment: Water Resources . The majority of potato production occurs with the use of irrigation. Crop production of any kind, including potatoes, can adversely impact water quality, primarily through sedimentation from erosion (surface water) and nutrient loading from fertilizers (groundwater).

Alternative I: No Action . If APHIS were to choose Alternative I: No Action, water withdrawals for irrigation would be expected t o continue. Supplemental irrigation may increase in some areas where potatoes have traditionally been grown without irrigation, and potential for water quality impacts will

continue.

Alternative II: Approval of Petition in Whole . As discussed above in Section 4.2, Agricultural
Production: General Production Practices , the evaluation presented in the petition (Collinge and Clark 2013) demonstrates that when growing these potatoes no changes will be needed in agronomic practices. As discussed in Section 4.2, agronomic practices that could affect water resources, such asEnvironmental Report Page 34

irrigation, cultivation, and pesticide and fertilizer application, were based on practices appropriate for each site, and were the same for the ten events and the controls. The results i ndicated that no changes
from the site

- specific practices used for conventional varieties would be needed for production of the ten events. Again, supplemental irrigation may increase in some areas where potatoes have traditionally been grown without irri gation, and potential for water quality impacts will continue.

Based on these results, if APHIS were to choose Alternative II: Approval of Petition in Whole, impacts to water resources resulting from this action are expected to be the same as if Alternati ve I: No Action had
been chosen.

Soil Quality

Soil quality, as related to potato production and the potential impacts on soil quality, is discussed in Section 2.3, Physical Environment: Soil Quality. The relatively high tillage requirements for a potato crop and the small amount of post

- crop plant material left in the soil can contribute to increased erosion potential. Cover crops are often planted to help mitigate this potential.

Alternative I: No Action . If APHIS were to choose Alternative I: No Act ion, current potato production practices and the associated impacts on the soil are expected to continue.

Alternative II: Approval of Petition in Whole . As discussed above in Section 4.2, Agricultural
Production: General Production Practices , the evalu ation presented in the petition (Collinge and Clark 2013) demonstrates that no changes to agronomic practices will be required, including cultivation (tillage), for production of any of the ten events. Except for the incorporated traits, the ten events ar e substantially equivalent to their conventional counterparts, thus no changes in plant/soil interaction are expected.

In summary, if APHIS were to choose Alternative II: Approval of Petition in Whole, agricultural impacts on soil quality are expected t o remain the same as they would if Alternative I: No Action was chosen.

Air Quality

Air quality and the Clean Air Act are discussed in Section 2.3, Physical Environment: Air Quality

. Emissions associated with crop production include vehicular emissions from the use of farm equipment, fugitive dust particles and releases of pesticides. Fugitive dust can arise from fields and unpaved roadways and can be generated by disturbance of ba re soil through vehicle traffic, harvesting operations or wind. These impacts are highly variable across potato growing regions and over time, depending on such factors as vehicle type, crop type, utilization of pesticides, method of application, soil typ e and
weather conditions.

Alternative I: No Action . If APHIS were to choose Alternative I: No Action, emissions associated with vehicles, fugitive dust particles and pesticides are expected to continue.

Alternative II: Approval of Petition in Whole

. As discussed above in Section 4.2, Agricultural
Production: General Production Practices , the evaluation presented in the petition (Collinge and Clark 2013) demonstrates that no changes to agronomic practices will be required to grow the potatoes. As
di scussed in Section 4.1, agronomic practices that could affect air quality, such as soil preparation, cultivation, pesticide application and harvesting, were based on practices appropriate for each site, andEnvironmental Report Page 35

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.

Based on these results, if APHIS were to choose Alternative II: Approval of Petition in Whole, impac ts to air quality resulting from this action are expected to be the same as if Alternative I: No Action had been
chosen.

Climate Change

Agricultural contributions to greenhouse gas emissions are discussed in Section 2.3, Physical
Environment: Climate Ch ange. In addition to the generation of carbon dioxide and other greenhouse gases from agricultural lands and the use of fossil

- fueled farm equipment, the primary contribution from crop farming is associated with agricultural soil management (fertilizer ap plication and other cropping practices which contribute NO 2 ).

Alternative I: No Action . If APHIS were to choose Alternative I: No Action, practices that contribute to greenhouse gas emissions are likely to continue; however, changes in practices to red uce emissions may be made in the future, either voluntarily or through future government regulations.

Alternative II: Approval of Petition in Whole . The evaluation presented in the petition (Collinge and Clark 2013) demonstrates that changes in agronom ic practices, including practices related to equipment operation and agricultural soil management such as fertilizer application would not be required for production of the ten events.

Based on these results, if APHIS were to choose Alternative II: Appr oval of Petition in Whole, impacts to air quality resulting from this action are expected to be the same as if Alternative I: No Action had been
chosen.

4.4. Biological Resources

Animal Communities

As discussed in Section 2.4, Biological Resources: Animal Communities, aside from the animals that may be living within an agricultural field, the animal communities most likely to be impacted by crop agriculture are those in the surrounding areas; aquatic communities are especially sensitive, and may be
affecte d by sedimentation and turbidity from erosion, or by pesticide runoff.

Alternative I: No Action . If APHIS were to choose Alternative I: No Action, animal communities living both within and outside of potato fields are expected to continue to experience impacts similar to the current impacts of agriculture.

Alternative II: Approval of Petition in Whole . As discussed in Section 4.2, Agricultural Production: General Production Practices, no changes in land use are expected if APHIS chooses Alternative II: Approval of Petition in Whole. In addition, the evaluation presented in the petition (Collinge and Clark 2013) demonstrates that changes in agronomic practices, including practices rela ted to pesticide use and erosion mitigation would not be required for production of the ten events. In addition, there are a large number of insects that feed on potato leaves and other insects that feed on those pests. Many of these insects, including the Colorado potato beetle, potato aphid, European corn borer, potatoEnvironmental Report Page 36

leafhopper and potato psyllid are considered pests. The events have not been modified to exhibit any pesticidal activities and do not contain pesticide

- expressing genes. No differences wer e observed for insects or other animals interacting within the potato ecosystem during the field trials, leading to the conclusion that the InnateTM potatoes would have the same impact on other organisms as conventional potatoes (Collinge and Clark 2013).

Based on these results, if APHIS were to choose Alternative II: Approval of Petition in Whole, impacts to animal communities resulting from this action are expected to be the same as if Alternative I: No Action
was chosen.

Plant Communities, Gene Flow, and Weediness

Plant communities are discussed in Section 2.4, Biological Resources: Plant Communities, Gene Flow, and
Weediness . This discussion focuses on the potential for gene flow with plants from related species. These include the two wild potato plant species found in the U.S., S. fendleri (also called S. stoloniferum )
and S. jamesii , and potential gene flow with other cultivated plants. There are no weed species in the U.S. with which potatoes can hybridize.

Because commercial potatoes reprodu ce vegetatively, gene flow among cultivated varieties is not an issue with either seed production or commercial potato production. The only threatened or endangered Solanum species are located in Puerto Rico and Hawaii, where
potatoes are not grown comme rcially.

Field hybridization between cultivated potatoes and the wild potato species S. fendleri and S. jamesii has not been observed, in spite of intensive study of wild potatoes in the U.S., and such hybridization is highly unlikely for the following reasons (as discussed in Section 2.4):

 There appears to be minimal, if any, geographic overlap. As discussed in Section 2.4, S. fendleri
and S. jamesii grow in isolated patches in mountainous areas of the Southwest at elevations over 5,000 feet. Of the states where the wild potatoes have been found, Utah does not have commercial potato production, only very small acreages are reported for New Mexico, and the area of Texas where wild potatoes are found is in the vicinity of commercial production areas.

R eported occurrences of these wild species in Colorado are very near the New Mexico border, and in mountainous areas. There is some potential for overlap in Arizona, however, the 3,700 acres of potato production represents 0.000051% of the area of the stat e. The total area of wild potatoes in the U.S. is not known; they grow in isolated colonies that are difficult even for experienced researchers to find.

 The most widely grown potato variety, Russet Burbank, is infertile.

 Among fertile varieties of culti vated potatoes, all are almost exclusively self

- pollinated, with approximately 80 to 100 percent of true seed having been derived from self

- pollination. As discussed in Section 2.4, an isolation distance of 20 meters is sufficient to prevent cross

pollina tion. S. fendleri is also highly self

- pollinated, and populations are genetically homogenous.Environmental Report Page 37

 Hybridization between cultivated potatoes and S. fendleri and S. jamesii has reportedly been achieved only by using specialized laboratory techniques (Love 19 94 p. 653), and has never been known to occur naturally (US EPA 2011d).

Alternative I: No Action. If APHIS were to choose Alternative I: No Action, the probability of the hybridization of cultivated varieties of potato with wild species of potato found within the U.S. would still be considered negligible, and any impacts to threatened or endangered species would remain similar to what is currently observed.

Alternative II: Approval of Petition in Whole . For the same reasons as described in the Alternat ive I: No Action section above, gene flow among cultivated varieties remains unlikely; there would be no impacts to threatened or endangered plant species and hybridization with wild potato species is not expected.

In this case, if APHIS were to choose Alternative II: Approval of Petition in Whole, the results would be
no different than if Alternative I: No Action was chosen.

Producers of organic true potato seed (TPS) will be able to protect their seed from the deregulated events by ensuring that the seed production fields are sufficiently isolated from commercial potato fields containing the events. Potential out

- crossing can be prevented by separating fields planted for organic TPS production by at least 20 meters from fields planted with these even ts, as is typical for spacing organic potato fields from fields where potatoes are produced with conventional methods (Connor and Dale 1996 pp. 505

- 506).

Microorganisms

Beneficial and detrimental microorganisms are discussed in Section 2.4, Biological R esources: Microorganisms . As noted there, growth of desirable microorganisms is facilitated by the presence of organic material and appropriate soil pH.

Alternative I: No Action . If APHIS were to choose Alternative I: No Action, potato crop interactions with microorganisms are expected to continue as they are presently.

Alternative II: Approval of Petition in Whole . As discussed in Section 4.2, Agricultural Production: General Production Practices, the evaluation presented in the petition (Collinge and Clark 2013) demonstrates that changes in agronomic practices, including practices related to soil preparation (which may impact soil organic material and pH) and to pesticide application (which may directly impact microorganisms), would not be required fo r production of the ten events. In addition, the ten events are substantially similar to their conventional counterparts. The biotech potato plants would therefore be expected to have the same interactions with soil microorganisms.

Based on these resu lts, if APHIS were to choose Alternative II: Approval of Petition in Whole, impacts to microorganisms resulting from this action are expected to be the same as if Alternative I: No Action was
chosen.Environmental Report Page 38

Biodiversity

General biodiversity and potato biodiv ersity are discussed in Section 2.4, Biological Resources: Biodiversity . As discussed in that section, while modern agricultural crop fields are relatively low in biodiversity, the high productivity of modern agriculture results in a smaller footprint for agriculture, leaving more land available for biodiversity. Potato biodiversity can be enhanced by the introduction of new genetic material from the large number of existing genetic resources available.

Alternative I: No Action . If APHIS were to choose Alternative I: No Action, increases in potato productivity are expected to continue to offset increased demand, resulting in a fairly constant acreage devoted to potato production in the U.S. (see discussion above Section 4.2, Agricultural Production:
Land Use ). This will allow for continued biodiversity outside the borders of agricultural fields. Biodiversity is expected to continue to be fairly low within agricultural fields.

Alternative II: Approval of Petition in Whole . As discussed in Section 4.2

, Agricultural Production: Land
Use, changes in land use are not expected. The evaluation presented in the petition (Collinge and Clark 2013) demonstrates that changes in agronomic practices would not be required for production of the
ten events. Based o n these results, if APHIS were to choose Alternative II: Approval of Petition in Whole, any impacts to biodiversity would be expected to be the same as if Alternative I: No Action was chosen.

If APHIS chooses Alternative II: Approval of Petition in Whole, potato biodiversity will be enhanced by the introduction of new genetic material through biotechnology and traditional breeding.

4.5. Human Health

Consumer Health

As discussed in Section 2.5, Human Health: Consumer Health, the potato crop is primarily grown for human consumption. U.S. per capita potato consumption is approximately 112 pounds per year. Of this, approximately 65 pounds is used for frozen fries or chips. Per capita consumption data are shown in
Table 6. As discussed in Section 2.5, potential toxins in potatoes are acrylamide (after cooking) and glycoalkaloids; patatin is an allergen for a very small percent of children.

Alternative I: No Action. Under this alternative, consumption of potatoes would be ex pected to continue much as it is currently. Consumers will continue to be exposed to similar levels of acrylamide in cooked potatoes if other methods are not employed to reduce levels. Glycoalkaloids would be expected to remain at sufficiently low levels such that health impacts would not occur. Patatin would remain a concern for those with the allergy.

Alternative II: Approval of Petition in Whole . The compositional analyses of the ten events are summarized in the petition, with detailed results in Appendix 9 (Collinge and Clark 2013). The compositional assessments determined the amounts of 1) moisture, protein, total fat, ash, crude fiber, carbohydrate and calories; 2) vitamins B6, B3 and C; 3) minerals copper, magnesium and potassium; 4) glycoalka loids; 5) free amino acids; 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 changes in ASN and reducing sugars accomplished through transformation of various pot ato varieties resulted in lower acrylamide levels in french fries and potato chips. These modifications did not alter the quality of potato as food because all results fell within normal ranges for potato. However, compared with theEnvironmental Report Page 39

conventional varieties, InnateTM potatoes contained, on average, 58 to 72 percent less acrylamide when cooked (Collinge and Clark 2013). Approval followed by widespread adoption of these potatoes could result in a significant reduction in dietary intake of acrylamide. In additi on, the research confirmed that glycoalkaloid levels were unchanged compared with the control varieties.

The National Academy of Sciences (NAS) has ranked methods of genetic modification according to the relative likelihood of unintended effects, such a s the increase in a plant’s production of certain allergens. The NAS considered methods that involve recombinant DNA via Agrobacterium transfer of genes from closely related species (the InnateTM method used to produce these 10 events is one such method th at doesn’t 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 che mical mutagenesis, which are not subject to regulation and are not excluded methods under the NOP (National Academy of Sciences 2004 p. 2).

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.

If APHIS were to choose Alternative II: Approval of Petition in Whole, and with the adoption of the potato events, consumers would likely be exposed to lower levels of acrylamide, a naturally

- occurring substance found to cause cancer in laboratory animals (NTP 2012). In conclusion, the data presented in the petition shows that the potato events are at least as safe and nutritious for food as the
untransformed controls.

Worker Safety

As summarized in Section 2.5, Human Health: Worker Health, farm workers are exposed to hazards associated with farm equipment and with pesticides, and are protected by the US EPA’s WPS.

Alternative I: No Action. If APHIS were to choose Alternative I: No Action, farm workers would continue to be exposed to the same kinds of hazards as they are currently.

Alternative II: Approval of Petition in Whole

. As discussed in Section 2.9, Typical Agronomic Practices, the evaluation presented in the petition (Collinge and Clark 2013) demonstrates that changes in agronomic practices

- including practices involving farm equipment use such as planting, harvesting a nd cultivating, and practices involving pesticide use would not be required for production of the ten events.

Based on these results, if APHIS were to choose Alternative II: Approval of Petition in Whole, impacts to worker health resulting from approval of the petition are expected to be the same as if Alternative I: No
Action was chosen.

4.6. Animal Feed

As discussed in Section 2.6, Animal Feed (Livestock Health), a small portion of the potato crop and waste from processing are sold as livestock feed.

Alternative I: No Action. If APHIS were to choose Alternative I: No Action, a small percent of the potato crop would continue to be used for livestock feed.Environmental Report Page 40

Alternative II: Approval of Petition in Whole . The compositional analyses of the ten events are summarized in Section 8 of the petition, with detailed results in Appendix 9 (Collinge and Clark 2013).
These results are summarized in the discussion of Human Health in section 4.5.

In conclusion, th e data presented in the petition shows that potatoes from the events are as safe and nutritious for feed as the untransformed controls, and if APHIS were to choose Alternative II: Approval of Petition in Whole, the use of potatoes as livestock feed would b e no different than if Alternative I: No
Action was chosen.

4.7. Socioeconomic Impacts

Domestic Economic Environment

The domestic economic environment is discussed in Section 2.7, Socioeconomic: Domestic Economic Environment, and potato utilization in the U.S. is summarized in Table 7. Potatoes are grown on approximately 1.1 million acres in the U.S., with an annual value of approximately $3.5 billion. Major products include fresh potatoes, frozen fries and chips. Organic potatoes account for less than o ne percent of the market.

Alternative I: No Action . If APHIS were to choose Alternative I: No Action, 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 p. 76).

Alternative II: Approval of Petition in Whole . If APHIS were to choose Alternative II: Approval of Petition in Whole, the ten events will become available for commercial production. Pot atoes 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 only the intended markets. This will provide a period of time to assess consumer accepta nce and to address grower and industry concerns. A limited introduction that is initially in a vertically integrated supply chain will be well controlled by grower and processor agreements. In this situation, conventional products will be considered “iden tity 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 implemented as needed. It is expected that development and imp lementation of identity preservation systems will add some cost to the supply chain; the total costs will depend upon the type and extent of market penetration (Collinge and Clark 2013).

Regarding consumer acceptance, studies have found that consumers ar e likely to be willing to pay a premium for a healthier food product (such as reduced acrylamide) developed by methods of biotechnology (Huffman 2010 p. 24; Colson et al. 2011 pp. 355

- 357).

Overall, if APHIS chooses Alternative II: Approval of Petition in Whole, the introduction of these potato events may 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.

Trade (International) Econom ic EnvironmentEnvironmental Report Page 41

As discussed in Section 2.7, Socioeconomic: Trade Economic Environment, the U.S. exports more than $1 billion in potato products annually, primarily consisting of frozen fries and other processed potatoes. Demand from Canada, Mexico and Asia is driving growth in exports. 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 Ca nada and Mexico (USDA ERS 2012c, p. 19).

Alternative I: No Action . If APHIS were to choose Alternative I: No Action, U.S. potato exports are expected to continue.

Alternative II: Approval of Petition in Whole . If APHIS were to choose Alternative II: Approval of Petition in Whole, U.S. potato exports are expected to continue. Approval for the events will be sought in Canada, Japan and Mexico (Collinge and Clark 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 genetically modified material were related to unapproved events; Japan has zero tolerance for unapproved events (Japan Times 2001, BBC 2001, Hur 2001). To assist in th e prevention 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 s tewardship 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 m arketplace, BIO’s Food and Agriculture Section supports actions that facilitate the flow of goods in commerce and minimize trade disruptions. BIO’s Food and Agriculture Section believes that henceforth individual member companies should, prior to commercia lization meet applicable regulatory requirements in key countries identified in a market and trade assessment that have functioning regulatory systems and are likely to import the new biotechnology

- derived plant products.

The voluntary guideline was adopt ed because, according to BIO “asynchronous 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 trad e disruptions will only 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 Innate TM potatoes are expected to be viewed more
favorabl y by regulatory organizations due to the lack of pesticidal traits and marker

- free transformation methods, and therefore have fewer implications for export markets. In any case, these approvals should ensure continued trade with key export markets.

If A PHIS were to choose Alternative II: Approval of Petition in Whole, 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 incu rred. Impacts to export markets will be mitigated by approvals in key trading countries such as Japan, Canada, and Mexico.Environmental Report Page 42

5. CUMULATIVE IMPACTS

Regulations promulgated by the Council on Environmental Quality (CEQ) under the National Environmental Policy Act (NEPA) define cumulative impact as “the impact on the environment which results from the incremental impact of the action when added to other past, present and reasonably foreseeable future actions” (40 CFR 1508.7). For example, the potential effects associated with a determination of nonregulated status of a GE crop in combination with the future production of crop plants with multiple traits that are no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of th e Plant Protection Act, including disease tolerance, nitrogen utilization, and herbicide tolerance, would be considered a cumulative impact. As detailed in Section 4, Environmental Consequences, Alternative II: Approval of Petition in Whole is not expected to result in any adverse impacts to any resources beyond those that would occur in the absence of approval of the petition (Alternative I: No Action). Therefore, if APHIS were to choose Alternative II: Approval of Petition in Whole, there will be no addi tional contributions to cumulative impacts, and no discussion of cumulative impacts is needed.

5.1. Assumptions Used for Cumulative Impacts Discussion

InnateTM potatoes will be cultivated to meet the needs of the consumer, grower, and processor, offering

pr otection 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 InnateTM potatoes, fewer potatoes will be lost to black spot bruise, resulting in less waste. As a result, there could be increases in yield, with associated positive environmental impacts related to land use and agricultural inputs. For the purposes of the cumulative impa cts discussion, however, it is assumed conservatively that land use and inputs would potentially decline or remain the same, and are unlikely to increase. Additionally, reduced levels of acrylamide in cooked potatoes will benefit the general public, by re ducing levels of this compound that has been linked to cancer in laboratory animals (NTP 2012).

In the future, additional biotech traits could be added to the InnateTM potatoes. After APHIS reaches a determination of nonregulated status, events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 would no longer be subject to the requirements of 7 CFR Part 340 and the plant pest provisions of the Plant Protection Act. When additional traits are added to these events, the new varieties would be evaluated by APHIS only as related to the new unapproved traits.

5.2. Cumulative Impacts: Land Use

Cumulative effects in land use resulting from a determination of nonregulated status of events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 are unlikely. With the reduction in black spot bruising, lower levels of reducing sugars, and reduced acrylamide potential, the InnateTM potatoes may gain more market share, partially replacing other varieties. However, the introduction of these varieties is not
expecte d to have an impact on overall demand for potatoes. With the public acceptance of biotech potatoes, additional traits could be added that would benefit the farmers, processors, and consumers. Also, even if the new traits provide environmental, economic o r health benefits, they are unlikely to alter the market demand for potatoes, and thus will not lead to significant changes in land used for potato production. In conclusion, land use is expected to stay the same for InnateTM and conventional potatoes and no cumulative impacts result.Environmental Report Page 43

5.3. Cumulative Impacts: General Agronomic Pract ices

Cumulative impacts of general agronomic practices for events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 are expected to be the same as conventional potatoes. Potatoes referred to as InnateTM have no additional insecticidal, miticidal, fungici dal, or herbicide tolerance activity and do not require additional or different agricultural inputs as shown by the plant characterization data in the Simplot Submission, when compared to the applicable controls.

As shown in the multi

- year field trial da ta for agronomic and phenotypic characterizations, no additional agricultural inputs were required compared to conventional potatoes. No significant differences were observed that would indicate an increase in agricultural inputs such as fertilizer, herbic ides, insecticides, miticides, and fungicides throughout the duration of the field trials. In conclusion, general agronomic practices are expected to stay the same for InnateTM and conventional potatoes and no cumulative impacts result.

5.4. Cumulative Impac ts: Organic Production Practices

Cumulative impacts on organic production practices concerning events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 are expected to be the same as with conventional potatoes. As shown in the multi

year field trial dat a, events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 potatoes do not grow any differently or have altered gene flow characteristics when compared to conventional potatoes. In the unlikely event that gene flow did happen between InnateTM and organi cally produced potatoes, the organic tubers would not be impacted because gene flow would impact seed, not the tubers sold commercially. In conclusion, InnateTM potatoes pose no more risk to organic growers than conventional potatoes and no cumulative impac ts would result from the approval of the petition for InnateTM
potatoes.

5.5. Cumulative Impacts: Water Resources

Cumulative impacts to water resources would be expected to be the same for events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 and convent ional potatoes. As discussed in Section 2.3, agricultural production in general, including potatoes, can adversely impact surface water quality primarily through sedimentation from erosion and nutrient loading from fertilizers. And, as previously discusse d in Section 4.2, agronomic practices that could affect water resources such as irrigation, cultivation, and pesticide and fertilizer application, were based on practices appropriate for each geographic location and were
the same for InnateTM and convention al potatoes. Therefore, cumulative impacts to water resources of InnateTM potatoes will be the same as conventional potatoes.

5.6. Cumulative Impacts: Soil Quality

Cumulative impacts to soil quality would be expected to be the same for events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 and conventional potatoes. As discussed in section 2.3, potatoes can be grown in a wide range of soil types and require more tillage than some other crops due to the irrigation and harvesting methods used in potatoes. U .S. potato production in general utilizes soil tillage operations to prepare the soil, practice mechanical weed control (particularly organic production), andEnvironmental Report Page 44

harvest the potatoes. In conclusion, events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 a re expected to have the same cumulative impacts on soil quality as conventional potatoes.

5.7. Cumulative Impacts: Air Quality

Cumulative impacts to air quality would be expected to be the same for events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 a nd conventional potatoes. As discussed in Section 2.3, air quality can be reduced by many agricultural operations including using a tractor for field operations that produce dust and emissions from the combustion of fossil fuels for mechanized agricultural equipment use. Air quality is expected to stay constant with respect to different agronomic practices, but will likely be reduced in the future due to advances in technology, e.g., lower emission diesel fuel that can be used in tractors and other farm equ ipment. In conclusion, events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 will have the same cumulative impacts on air quality as conventional potatoes.

5.8. Cumulative Impacts: Climate Change

Cumulative impacts due to climate change would be the same for events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 and conventional potatoes. As discussed in Section 2.3, potato production and agriculture in general may contribute to climate change, if it occurs, as a result of the generation of carbon dioxide and other greenhouse gases resulting from agricultural production. Potato production in the United States has a fairly small production footprint (approximately 1 million acres, USDA NASS 2012) when compared to row crops like corn (approximately 97 million) and soybeans (approximately 86 million acres). Considering the production acres, potatoes, including the InnateTM varieties, will have less impact on climate change than the higher acreage cro ps. In conclusion, events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 are expected to have the same cumulative impacts on climate change as conventional potatoes.

5.9. Cumulative Impacts: Animal Communities

Cumulative impacts to animal communities would be the same for events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 and conventional potatoes. Three years of field data as well as compositional analysis and molecular stability show that events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 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 p esticides. These data show that there is the same impact (and expected cumulative impacts) on non

- target animals or animal communities within the potato agroecosystem for events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 as the conventional
potato es.

5.10. Cumulative Impacts: Plant Communities, Gene Flow, and Weediness

Cumulative impacts to plant communities resulting from gene flow or weediness potential would be the
same for events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 and convention al potatoes. Multiple years of field data as well as compositional analysis show that events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 and are equivalent to conventional potatoes. Also, no changes were observed in land use or agronomic inputs inc luding pesticides and herbicides. Gene flow from potatoes whether biotech or conventional is unlikely due to the cropping practices of rotation and the clonal propagation of potatoEnvironmental Report Page 45

varieties in U.S. agriculture. Additionally as described in the Simplot Sub mission and in Section 2 of this ER, conventional potatoes and events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 show no apparent weediness. As a result, events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50, like conventional potatoes, would grow poorly outside of cultivation. While there is some potential for volunteer potatoes to grow, it would be the same for the events and controls. Potato growing methods include rotation and other agronomic practices to minimize the impact of volunteer s in both conventional and InnateTM potato production. In conclusion, events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 are expected to have the same cumulative impacts on plant communities as conventional
potatoes.

5.11. Cumulative Impacts: Microorga nisms

Cumulative impacts to microorganisms are expected to be the same for events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 and conventional potatoes. Microorganisms are a diverse group of organisms that flourish in and around agricultural cropp ing systems. Microorganisms include everything from pathogens to symbiotic bacteria to decomposers within the various trophic levels of the potato agroecosystem. Data presented in the Simplot Submission show that no significant impacts were
observed in mul tiple years of field data (agronomic and phenotypic characteristics and ecological interactions), disease assays conducted in the field and laboratory, as well as compositional equivalence studies. Therefore cumulative impacts of events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 to microorganisms are expected to be the same as conventional potatoes.

5.12. Cumulative Impacts: Biodiversity

Cumulative impacts to biodiversity would be expected to be the same for events E12, E24, F10, F37, J3, J55, J78, G1 1, H37, and H50 and conventional potatoes. InnateTM and conventional potatoes were shown to be substantially equivalent based on multiple years of field data, disease assays conducted in the field and laboratory, as well as compositional equivalence studies . Therefore, InnateTM and conventional potatoes responded similarly in all studies and would have a similar cumulative impact on biodiversity.

5.13. Cumulative Impacts: Consumer Health

Cumulative effects on consumer health are expected to be the same for even ts E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 and conventional potatoes, with one exception: The InnateTM potatoes contain significantly less acrylamide forming potential than conventional potatoes. The Simplot
Submission discusses consumer health and the relevance for acrylamide, glycoalkaloids, and patatin in
potatoes.

Reductions in ASN and reducing sugars resulted in lower acrylamide levels in french fries and potato chips. These modifications did not alter the quality of potato as food because all results fell within normal ranges for potato. Compared with the conventi onal varieties, InnateTM potatoes contained on average 58 to 72 percent less acrylamide (Collinge and Clark 2013). Adoption of these potatoes could result in a significant reduction in dietary intake of acrylamide and decrease exposure to this naturally

oc curring substance found to cause cancer in laboratory animals (NTP 2012).

In addition, the research confirmed that glycoalkaloid levels were unchanged compared with the control varieties. Although patatin was not measured during the studies, total prot ein did not differ between InnateTM and conventional potatoes and it was concluded that any potential allergy to patatin would beEnvironmental Report Page 46

the same. In conclusion, cumulative impacts of the InnateTM potatoes could positively affect human
health with a reduction in a crylamide exposure and t he InnateTM potatoes are expected to have the same levels of glycoalkaloids and patatin as conventional potatoes.

5.14. Cumulative Impacts: Worker Safety

Cumulative impacts to worker safety would be expected to be the same for events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 and conventional potatoes. The multi

- year field trials showed no differences in plant phenotype and no additional agricultural inputs were required compared to conventional potatoes. It was concluded that no change in agricultural inputs such as fertilizer, herbicides, insecticides, miticides, and fungicides was needed between InnateTM and conventional potatoes. As a result, since farming practices are expected to remain the same, cumulative impacts on

wor ker safety would be the same whether growing InnateTM or conventional potatoes.

5.15. Cumulative Impacts: Animal Feed (Livestock Health)

Cumulative impacts to livestock health from potatoes used as feed would be expected to be the same
for events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 and conventional potatoes. The compositional assessments determined the amounts of 1) moisture, protein, total fat, ash, crude fiber, carbohydrate and calories; 2) vitamins B6, B3 and C; 3) minerals coppe r, magnesium and potassium; 4) glycoalkaloids; 5) free amino acids; and 6) total amino acids. Although some differences were observed, all results fell within the normal range for potato and it was concluded that food quality would be the
same for InnateTM and conventional potatoes.

In addition, the research confirmed that glycoalkaloid levels were unchanged compared with the control varieties. Although patatin was not measured during the studies, total protein did not differ between
InnateTM and conventi onal potatoes and it was concluded that any potential allergy to patatin would be the same. In conclusion, cumulative impacts of the InnateTM potatoes would be the same as conventional potatoes since all nutrients fell within normal levels for potato. In addition, InnateTM potatoes are expected to have the same levels of glycoalkaloids and patatin as conventional potatoes.

5.16. Cumulative Impacts: Domestic Economic Environment

Cumulative impacts on the domestic economic environment would be similar for even ts E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 and conventional potatoes, although some economic impact is expected because of the benefits of the new potatoes. These events grow similarly and have similar biochemical composition to conventional p otatoes, however, the low acrylamide, reducing sugars, and black spot bruise traits add 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 marke t value for the same inputs, representing potential increased revenue for growers and processors, and an overall increase in the value of potato production.

Consumer and market acceptance will be required for the InnateTM potatoes to gain significant mark et share. Widespread adoption of other biotech crops should lead to similar adoption of potatoes, especially with the addition of traits that provide health benefits (reduced acrylamide potential) for consumers and quality improvements (low black spot bru ise and reduced levels of reducing sugars) for

processors. Additionally, potatoes are often processed into fries and chips which already utilize biotechnology derived foods such as high oleic oils.Environmental Report Page 47

Introduction of InnateTM potatoes will require channelin g of the new potatoes into the desired markets. The careful supply chain introduction would be similar to all potato variety management systems already in place for product purity. It is expected that development and implementation of identity preservati on systems will add some cost to the supply chain; the total costs will depend upon the type and extent of market penetration (Collinge and Clark 2013). In conclusion, the InnateTM potatoes could have cumulative economic impacts on the domestic potato mar ket, public acceptance will be learned after approval, and procedures will be developed to manage product purity in the supply chain.

5.17. Cumulative Impacts: Trade (International) Economic Environment

Cumulative impacts to the trade economic environment wou ld be similar for events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 and conventional controls, although some economic impact is expected because of the benefits 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. 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.

Introduction of InnateTM potatoes will require channeling of the new potatoes into the desired markets, and avoidance of those who chose not to use the new potatoes. The careful supply chain introduction would be similar to all potato variety management systems already in place for product pur ity. It is expected that development and implementation of identity preservation systems will add some cost to the supply chain; the total costs will depend upon the type and extent of market penetration (Collinge and Clark 2013).

Upon introduction, proc edures will be implemented to prevent unintended mixing of 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 import and cultivation. Approval in these key trading countries will minimize market disruption should a low level presence of InnateTM potatoes be found in the market from accidental mixing. In conclusion, the Inna teTM potatoes could have cumulative trade economic impacts on the potato export market and procedures will be developed to manage product purity in the supply chain.Environmental Report Page 48

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