hmateTM Potato with Low Acrylamide Potential and Reduced Black Spot Bruise Events El2 and 

E24 (Russet Burbank); FlO and F37 (Ranger Russet); 13,155, and 178 (Atlantic); Gll (G); H37 

and H50 (H) 

United States Department of Agriculture 

Animal and Plant Health Inspection Service 

Biotechnology Regulatory Services 

The United States Department of Agriculture (USDA), Animal and Plant Healtl1 Inspection 

Service (APHIS) has developed this decision document to comply with the requirements of the 

National Environmental Policy Act (NEPA) of1969, as amended, the Council of Environmental 

Quality's (CEQ) regulations implementing NEPA, and the USDA APHIS' NEPA implementing 

regulations and procedures. This NEPA decision document, a Finding of No Significant Impact 

(FONSI), sets forth APHIS' NEP A decision and its rationale. Comments from the public 

involvement process were evaluated and considered in developing this NEP A decision. 

In accordance with APHIS procedures implementing NEPA (7 CFR part 372), APHIS has 

prepared an Environmental Assessment (EA) to evaluate and determine ifthere are any 

potentially significant impacts to the human environment from a detennination on the regulated 

status of a petition request (APHIS Number 13-022-01 p) by Simp lot Company (hereafter 

referred to as Simp lot) for fueir genetically engineered ItmateTM potato tl1at has reduced 

acrylamide potential and reduced black spot bruising. The EA has been prepared in order to 

specifically evaluate the effects on the quality of the human environment that may result from 

approving the petition seeking nonregulated status for InnateTM Potato. The EA assesses 

alternatives to a detennination ofnonregulated status oflnnateTM Potato and analyzes the 

potential environmental and social effects that may result from tl1e proposed action and the 

altematives. 

Regulatory Authority 

"Protecting American agriculture" is the basic charge of APHIS. APHIS provides leadership in 

ensuring the health and care of plants and animals. The agency improves agricultural 

productivity and competitiveness, and contributes to the national economy and the public health. 

USDA asserts that all methods of agricultural production (conventional, organic, or the use of 
, p

y 

gy 

y

comprehensive federal regulatory policy for ensuring the safety of biotechnology research and 

products and explains how federal agencies will use existing Federal statutes in a manner to 

ensure public health and enviromnental safety while maintaining regulatory flexibility to avoid 

impeding the growth of the bioteclmology industry. The Coordinated Framework is based on 

several important guiding principles: (1) agencies should define those transgenic organisms 

subject to review to the extent pennitted by their respective statutory authorities; (2) agencies are 

required to focus on the characteristics and risks of the biotechnology product, not the process by 

which it is created; (3) agencies are mandated to exercise oversight of GE organisms only when 

there is evidence of "unreasonable" risk. 

The Coordinated Framework explains the regulatory roles and authorities for the three major 

agencies involved in regulating GE organisms: USDA's APHIS, the Food and Drug 

Administration (FDA), and the Enviromnental Protection Agency (EPA). 

APHIS is responsible for regulating GE organisms and plants under the plant pest provisions in 

the Plant Protection Act of2000, as amended (7 USC§§ 7701 et seq.) to ensure that they do not 

pose a plant pest risk. 

The FDA regulates GE organisms under the authority of the Federal Food, Drug, and Cosmetic 

Act (FFDCA). The FDA is responsible for ensuring the safety and proper labeling of all plantderived foods and feeds, including those that are genetically engineered. To help developers of 

food and feed derived from GE crops comply with their obligations under Federal food safety 

laws, FDA encourages them to participate in a voluntary consultation process. The FDA policy 

statement conceming regulation of products derived from new plant varieties, including those 

genetically engineered, was published in the Federal Register on May 29, 1992 (57 FR 22984-

23005). Under this policy, FDA uses what is tenned a consultation process to ensure that human 

food and animal feed safety issues or other regulatory issues (e.g., labeling) are resolved prior to 

commercial distribution of bioengineered foods. 

The EPA regulates plant-incorporated protectants under the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA). EPA also sets tolerance limits for residues of pesticides on and in 

food and animal feed, or establishes an exemption from the requirement for a tolerance, under 

the Federal Food, Drug and Cosmetics Act (FFDCA) and regulates ce1iain biological control 

organisms under the Toxic Substances Control Act (TSCA). The EPA is responsible for 
allows for the safe development and use of GE organisms. APHIS regulations at 7 Code of 

Federal Regulations (CFR) part 340, which were promulgated pursuant to authority granted by 

the Federal Plant Pest Act, and further consolidated under the Plant Protection Act, as amended 

(7 United States Code (U.S.C.) 7701-7772), regulate the introduction (importation, interstate 

movement, or release into the environment) of certain GE organisms and products. AGE 

organism is no longer subject to the plant pest provisions of the Plant Protection Act or to the 

regulatory requirements of 7 CFR part 340 when APHIS determines that it is unlikely to pose a 

plant pest risk. A GE organism is considered a regulated article if the donor organism, recipient 

organism, vector, or vector agent used in engineering the organism belongs to one of the taxa 

listed in the regulation (7 CFR 340.2) and is also considered a plant pest. A GE organism is also 

regulated under Part 340 when APHIS does not have infonnation to detennine if the GE 

organism is unlikely to pose a plant pest risk. 

A person may petition the agency that a particular regulated article is unlikely to pose a plant 

pest risk, and, therefore, is no longer regulated under the plant pest risk provisions of the Plant 

Protection Act or the regulations at 7 CFR 340. The petitioner is required to provide infonnation 

under §340.6(c) (4) related to plant pest risk that the agency may use to determine whether the 

regulated article is unlikely to present a greater plant pest risk than the unmodified organism. A 

GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant 

pest risk provisions of the Plant Protection Act when APHIS determines that it is unlikely to pose 

a plant pest risk. 

APHIS' Response to Petition for Nonregulated Status 

Under the authority of the plant pest provisions of the Plant Protection Act (PP A) and 7 CFR 

Part 340, APHIS has issued regulations for the safe development and use of GE organisms. As 

required by 7 CFR 340.6, APHIS must respond to petitioners who request a determination of the 

regulated status ofGE organisms, including GE plants such as IlmateTM potato. When a petition 

for nonregulated status is submitted, APHIS must make a determination, based upon a Plant Pest 

Risk Assessment (PPRA) process detennination, whether the GE organism of concem is likely to 

pose a plant pest risk as defined by the PP A. If APHIS dete1mines, based on its Plant Pest Risk 

Assessment (PPRA) detennination, that the GE organism is unlikely to pose a plant pest risk, 

then that genetically engineered organism is no longer subject to the plant pest provisions of the 

Plant Protection Act and 7 CFR part 340. 
of nonregulated status for InnateTM potato with reduced acrylamide potential and reduced black 

spot bruising. A determination ofnomegulated status for InnateTM potato would include 

InnateTM Potato, any progeny derived from crosses between InnateTM and conventional potatoes 

or other GE potato events that have been deregulated pursuant to Part 340 and the Plant 

Protection Act. IfinnateTM potato is deregulated, growers and potato seed suppliers would have 

another variety of potato. 

InnateTM potato is currently regulated under 7 CFR part 340. Interstate movements and field 

trials ofinnateTM potato have been conducted under notifications (14) acknowledged by APHIS 

from 2009 through 2011 in eight states: Florida, Indiana, Idaho, Michigan, Nebraska, North 

Dakota, Washington, and Wisconsin. Data resulting from these field trials are described in 

Appendix 6 of the petition (Simplot, 2013a). 

Coordinated Framework Review 

Food and Drug Administration 

InnateTM potato is within the scope of the FDA policy statement concerning regulation of 

products derived from new plant varieties, including those produced by genetic engineering. In 

June 2006, FDA published recommendations in "Guidance for Industry: Recommendations for 

the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant 

Varieties Intended for Food Use" (US-FDA, 2011) for establishing voluntary food safety 

evaluations for new non-pesticidal proteins produced by new plant varieties intended to be used 

as food, including bioengineered plants. Early food safety evaluations help make sure that 

potential food safety issues related to a new protein in a new plant variety are addressed early in 

development. These evaluations are not intended as a replacement for a biotechnology 

consultation with FDA, but the infonnation may be used later in the biotechnology consultation. 

On February 12, 2013, Simplot submitted a safety and nutritional assessment of food and feed 

derived from InnateTM potato to the FDA (US-FDA Docket Number BNF 141). FDA is currently evaluating the submission. No questions have been raised thus far pursuant to §408( d) 

of the Federal Food, Drug, and Cosmetic Act. 

Environmental Protection Agency 

Under FIFRA, all pesticides (including herbicides) sold or distributed in the U.S. must be 

registered by the EPA (US-EPA, 20lla). Registration decisions are based on scientific studies 
that can remain on the crop or in foods or feed processed from that crop (US-EPA, 20llb). 

The EPA regulates plant-incorporated protectants (PIPs) under the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) and certain biological control organisms under the 

Toxic Substances Control Act (TSCA). The EPA is responsible for regulating the sale, 

distribution and use of pesticides, including pesticides that are produced by an organism through 

techniques of modem biotechnology. 

Scope of the Environmental Analysis 

Although a determination of nonregulated status oflnnateTM potato would allow for new 

plantings oflnnateTM potato anywhere in the U.S., APHIS primarily focused the enviromnental 

analysis on those geographic areas that currently support potato production. A determination of 

nonregulated status of InnateTM potato is not expected to increase potato production, either by its 

availability alone or accompanied by other factors, or cause an increase in overall GE potato 

acreage. To determine areas of potato production, APHIS used data from the National 

Ag~icultural Statistics Service (USDA-NASS, 201 0) to determine where potato is produced in 

the U.S. (USDA-NASS, 201 0). Potato is primarily produced in Idaho, Washington, Wisconsin, 

North Dakota, Wisconsin, Colorado, Minnesota, Michigan, Maine, Califomia, and Oregon. 

These eleven states comprised approximately 92.3% percent of the nation's potato production of 

437,483,000 CWT in 2012 (USDA-NASS, 2012a; 2012b). 

Public Involvement 

On May 3, 2013, APHIS published a notice in the Federal Register (78FR 25942-25943, Docket 

no. APHIS-2012-0067) announcing the availability of the Simplot petition for a 60-day public 

review and comment period. Cmnrnents were required to be received on or before July 2, 2013. 

All comments were carefully analyzed to identify new issues, alternatives, or information. A 

total of308 comments 1 on the petition were received from individuals during the comment 

period. One of the comments had 41,475 sig11atures appended to it. Many of the commenters did 

not mention their specific disagreement with APHIS' analysis oflnnateTM potato detailed in the 

EA or PPRA (USDA-APHIS, 2013a); rather, they expressed their general opposition to 

1 

• Comment documents may be viewed at: http://www.regulations.gov/#!docketBrowser;rpp~25;po~O;D~APHIS2012-0067;dct~PS 
subsequent to the draft EA and PPRA publication. The docket folder containing the comments 

can be located at 

http://www.regulations.gov/#!docketBrowser;rpp=25;po=O;dct=SR;D=APHIS-2012-0067 

Responses to substantive comments are included as an attachment to this Finding of No 

Significant Impact. 

Major Issues Addressed in the EA 

The issues considered in the EA were developed based on APHIS' detennination that these 

genetically engineered potatoes are no longer subject to the plant pest provisions of the Plant 

Protection Act and 7 CFR part 340, and for this particular EA, the specific petition seeking a 

determination of nonregulated status for InnateTM potato. Issues discussed in the EA were 

developed by considering public concems as well as issues raised in public comments submitted 

for other environmental assessments of genetically engineered organisms, concems raised in 

lawsuits, as well as those issues that have been raised by various stakeholders. These issues, 

including those regarding the agricultural production of potato using various production 

methods, and the environmental food/feed safety of genetically engineered plants were addressed 

to analyze the potential environn1ental impacts oflnnateTM potato. 

The list of resource areas considered were developed by APHIS through experience in 

considering public concems and issues raised in public comments submitted for other EAs of GE 

organisms. The resource areas considered also address concems raised in previous and unrelated 

lawsuits, as well as issues that have been raised by various stakeholders in the past. The 

following issues were identified as important to the scope of the analysis ( 40 CFR 1508.25). 

These resource areas can be categorized as follows: 

Agricultural Production Considerations: 

a Acreage and Areas of Potato Production 

e Agronomic/Cropping Practices e Potato Seed Production e Organic Potato Production 

Environmental Considerations: 

e Water Resources 
e Microorganisms 

0 Biological Diversity 

Human Health Considerations: 

e Public Health 

e Worker Safety 

Livestock Health Considerations: 

e Livestock Health/ Animal Feed 

Socioeconomic Considerations: 

<> Domestic Economic Enviromnent 

" Organic Farming 

" Trade Economic Environment 

Alternatives that were fully analyzed 

The EA analyzes the potential environmental consequences of a detennination of nonregulated 

status of InnateTM potato. To respond favorably to a petition for nonregulated status, APHIS 

must determine that InnateTM potato is unlikely to pose a plant pest 1isk. Based on its Plant Pest 

Risk Assessment (USDA-APHIS, 2013a), APHIS has concluded that InnateTM potato is unlikely 

to pose a plant pest risk. Therefore, APHIS must detennine that InnateTM potato is no longer 

subject to 7 CFR part 340 or the plant pest provisions of the Plant Protection Act. Two 

alternatives were evaluated in the EA: (I) no action and (2) detennination ofnonregulated status 

oflnnateTM potato. APHIS has assessed the potential for environmental impacts for each 

alternative in the Environmental Consequences section of the EA. 

No Action: Continuation as a Regulated Article 

Under the No Action Alternative, APHIS would deny the petition. InnateTM potato and progeny 

derived from InnateTM potato would continue to be regulated articles under the regulated articles 

under the regulations at 7 CFR part 340. Pennits or notifications acknowledged by APHIS 

would still be required for introductions oflnnateTM potato and measures to ensure physical and 

reproductive confinement would continue to be implemented. APHIS might choose this 
p

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p

g 

p

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Preferred Alternative: Determination that InnateTM Potato is No Longer a Regulated 

Article 

Under this alternative, InnateTM potato and progeny derived from them would no longer be 

regulated articles under the regulations at 7 CFR part 340. InnateTM potato is unlikely to pose a 

plant pest risk (USDA-APHIS, 2013a). Permits issued or notifications acknowledged by APHIS 

would no longer be required for introductions of InnateTM potato and progeny derived from this 

event. The Preferred Alternative, i.e., a detennination of nonregulated status oflnnateTM potato, 

is not expected to increase potato production, either by its availability alone or associated with 

other factors, or result in an increase in overall acreage of GE potato. Potential impacts would be 

similar to the No Action Alternative. This alternative best meets the purpose and need to 

respond appropriately to a petition for nonregulated status based on the requirements in 7 CFR 

part 340 and the agency's authority under the plant pest provisions of the Plant Protection Act. 

Because the agency has concluded that InnateTM potato is unlikely to pose a plant pest risk, a 

determination of nonregulated status oflnnateTM potato is a response that is consistent with the 

plant pest provisions of the PP A, the regulations codified in 7 CFR part 340, and the 

biotechnology regulatory policies in the Coordinated Framework. 

Alternatives Considered but Re.jected from Further Consideration 

APHIS assembled a list of alternatives that might be considered for InnateTM potato. The agency 

evaluated these alternatives, in light of the agency's authority under the plant pest provisions of 

the Plant Protection Act, and the regulations at 7 CFR part 340, with respect to environmental 

safety, efficacy, and practicality to identify which alternatives would be further considered for 

InnateTM potato. Based on this evaluation, APHIS rejected several alternatives. These 

alternatives are discussed briefly below along with the specific reasons for rejecting each. 

Prohibit any InnateTM Potato from Being Released 

In response to public cmmnents that stated a preference that no G E organisms enter the 

marketplace, APHIS considered prohibiting the release oflnnateTM potato, including denying 

any pennits associated with the field testing. APHIS determined that this altemative is not 

appropriate given that APHIS has concluded that InnateTM potato is unlikely to pose a plant 

health risk (USDA-APHIS, 2013a). 
broad principles, consistent with Executive Order 13563, to guide the development and 

implementation policies for oversight of emerging technologies (such as genetic engineering) at 

the agency level. In accordance with this memorandum, agencies should adhere to Executive 

Order 13563, and, consistent with that Executive Order, the following principle, among others to 

the extent permitted by law when regulating emerging teclmologies. 

"[D]ecisions should be based on the best reasonably obtainable scientific, teclmical, economic, 

and other information, within the boundaries of the authorities and mandate of each agency" 

Based on the PPRA (USDA-APHIS, 2013a), and the scientific data evaluated therein, APHIS 

concluded that InnateTM potato is unlikely to pose a plant pest risk. Accordingly, there is no 

basis in science for prohibiting the release oflnnateTM potato. 

Approve the petition in part 

The regulations at 7 CFR 340.6( d) (3)(i) state that APHIS may "approve the petition in whole or 

in part." For example, a determination ofnonregulated status in part may be appropriate ifthere 

is a plant pest risk associated with some, but not all lines described in a petition. Because APHIS 

has concluded that IlmateTM potato is unlikely to pose a plant pest risk, (USDA-APHIS, 2013a) 

there is no regulatory basis under the plant pest provisions of the Plant Protection Act for 

considering approval of the petition only in part. 

Isolation Distance between InnateTM Potato and Non-GE Potato Production and Geographical 

Restrictions 

Because APHIS has concluded that InnateTM potato is unlikely to pose a plant pest risk (USDAAPHIS, 2013a), an alternative based on requiring isolation distances would be inconsistent with 

the statutory authority under the plant pest provisions of the Plant Protection Act and regulations 

in 7 CFR part 340. 

In response to public concerns of gene movement between GE and non-GE plants, APHIS 

considered requiring an isolation distance separating InnateTM potato from conventional or 

specialty potato production. APHIS also considered geographically restricting the production of 

InnateTM potato based on the location of production of non-GE potato in organic production 

systems or production systems forGE-sensitive markets in response to public concerns regarding 

possible gene movement between GE and non-GE plants. However, as presented in APHIS' 

plant pest risk assessment for InnateTM potato, there are no geographic differences associated 
Framework. Based on the foregoing, the imposition of isolation distances or geographic restrictions would not 

meet APHIS' purpose and need to respond appropriately to a petition for nonregulated status 

based on the requirements in 7 CFR part 340 and the agency's authority under the plant pest 

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

geographically isolate their non-GE potato production systems from InnateTM potato or to use 

isolation distances and other management practices to minimize gene movement between 

InnateTM potato and non-GE potato fields. Infonnation to assist growers in making infonned 

management decisions for InnateTM potato is available from the Association of Official Seed 

Certifying Agencies (AOSCA, 2010)). 

Requirement of Testing for InnateTM Potato 

During the comment periods for other petitions for nonregulated status, some commenters 

requested that USDA require and provide testing forGE products in non-GE production systems. 

APHIS notes that there are no nationally-established regulations involving testing, ctiteria, or 

limits of GE material in non-GE systems. Such a requirement would be extremely difficult to 

implement and maintain. Additionally, because InnateTM potato does not pose a plant pest 

risk(USDA-APHIS, 2013a), the imposition of any type of testing requirements is inconsistent 

with the plant pest provisions of the Plant Protection Act, the regulations at 7 CFR part 340 and 

biotechnology regulatory policies embodied in the Coordinated Framework. Therefore, 

imposing such a requirement for hmateTM potato would not meet APHIS' purpose and need to 

respond appropriately to the petition in accordance with its regulatory authorities. 

Environmental Consequences of APHIS' Selected Action 

The EA contains a full analysis of the altematives to which we refer the reader for specific 

details. The following table briefly summarizes the results for each of the issues fully analyzed 

in the Environmental Consequences section of the EA. 

Attribute/Measure Alternative A: No Action Alternative B: Determination ofNonregulated 

Status 

Meets Purpose and No Yes 

Need and 

Ob.iectives 

Unlikely to pose a Satisfied through use of regulated field trials Satisfied-risk assessment (USDA-APHIS, 

plant pest risk 20 13a) 

Management 
Practices as used currently. 

Pesticide Use Pesticides are currently used to control Unchanged from No Action Alternative 

insects, nematodes, fungi, and weeds. 

Potato Seed Potato seed is primarily supplied by seed Unchanged from No Action Alternative 

Production potatoes. 

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

Production standards for production, cultivation, and 

product handling and processing to ensure 

that their products are not pollinated by or 

commingled with conventional or GE crops. 

Environment 

Land Use Current trends in the acreage and areas of Unchanged from No Action Alternative 

production are likely to continue to be 

driven by market conditions (i.e., increased 

demand for US potato and potato products 

for animal feed, etc.) and federal policy. 

Water Resources The primary cause of agricultural NPS Unchanged from No Action Alternative 

pollution is increased sedimentation from 

soil erosion, which can introduce sediments, 

fertilizers, and pesticides to nearby lakes 

and streams. Agronomic practices such as 

conservation tillage, crop nutrient 

management, pest management, and 

conservation buffers help protect water 

quality from agricultural runoff. 

Soil Growers will adopt management practices to Unchanged from No Action Alternative 

address their specific needs in producing 

potatoes. Erosion potential may continue to 

increase. 

Air Quality Agricultural activities such as burning, Unchanged from No Action Alternative 

tilling, harvesting, spraying pesticides, and 

fertilizing, including the emissions from 

farm equipment, can directly affect air 

quality. Aerial application of insecticides 

may impact air quality from drift, diffusion, 

and volatilization of the chemicals, as well 

as motor vehicle emissions from airplanes 

or helicopters. 

Climate Change Agriculture-related activities are recognized Unchanged from No Action Alternative 

as both direct sources of greenhouse gases 

(GHGs) (e.g., exhaust from motorized 

equipment) and indirect sources (e.g., 

agriculture-related soil disturbance, fertilizer 

production). 
Plants Potatoes are a labor intensive, highly In the unlikely event of hybridization of 

managed crop. Members of the plant InnateTM potato with conventional 

community that adversely affect potato resulting progeny may contain lowered 

production may be characterized as weeds. polyphenol oxidase levels. However, this is 

Weed control is an important aspect of not expected to be detrimental. Innate"' 

potato production. Potato growers use potato is no weedier than conventional 

production practices to manage weeds in potatoes. 

and around potato fields. 

Gene Movement Since potato is primarily vegetatively InnateTM traits are not expected to increase 

propagated, gene flow between cultivars is weediness in potato. 

low. Volunteer potatoes would continue to 

need to be controlled, although their 

survival is low. 

Soil Abundance and diversity of soil Unchanged from No Action Alternative 

Microorganisms microorganisms in and around potato fields 

is expected to remain as it is currently. 

Biological Diversity The biological diversity in potato fields is Unchanged from No Action Alternative 

lower than in the surrounding habitats. 

Human and 

Animal Health 

Risk to Human Glycoalkaloids and patatins would continue Glycoalkaloid and patatin exposure would 

Health to pose a risk to human health. In the case continue. For humans consuming highof humans consuming high-temperature temperature cooked potatoes, acrylamide 

cooked potatoes, they would continue to be levels would be reduced approximately 60-

exposed to acrylamide. 70%, which will benefit human health. 

Risk to Animal Glycoalkaloids would continue to pose a Unchanged from No Action Alternative. 

Feed risk to livestock if potato stems and foliage 

are fed to them, which is not likely. 

Socioeconomic 

Domestic and Most potato production is used for food. Because of its potential human health benefits 

Economic Market utilization would likely continue as (lower acrylamide) and potential reduced Environment it is currently. wastage (low bruising), InnateTM potato may 

comprise a larger share of the domestic potato 

market, and may result in increased revenues. 

Trade Economic U.S. potatoes and potato products will The foreign trade impacts associated with a 

Environment continue to play a role in global potato determination of nonregulated status of 

production, and the U.S. will continue to be InnateTM potatoes are anticipated to be similar 

a supplier in the international market. to the No Action Alternative. However, 

import of each specific trait requires separate 

application and approval by the importing 

country. If the Innate"' traits are approved by 

importing countries, it may make up a larger 

percentage of potato import markets. 

Other Regulatory FDA completed consultations, EPA FDA is currently reviewing Simplot's 

Approvals tolerance exemptions and conditional voluntary consultation submission of 

pesticide registrations granted February 12, 2013. 
The analysis in the EA indicates that there will not be a significant impact, individually or 

cumulatively, on the quality of the human environment as a result of this proposed action. I 

agree with this conclusion and therefore find that an EIS need not be prepared. This NEP A 

determination is based on the following context and intensity factors (40 CFR 1508.27). 

Context - The tenn "context" recognizes potentially affected resources, as well as the location 

and setting in which the environmental impact would occur. This action has potential to affect 

conventional and organic potato production systems, including surrounding environments and 

agricultural workers; human food and animal feed production systems; and foreign and domestic commodity markets. 

In the 2012 production year, potato was cultivated in the United States on approximately 1.2 

million acres, representing a 4.5% increase in potato acreage from 2011 (USDA-NASS, 2012a). 

Potato production in 2011 was estimated at $336.37/CWT and valued at an estimated $7.90 to 

$23.70/CWT (USDA-NASS, 2012a). Potato acres harvested in the U.S. have declined over 

recent years, while total production has increased. Per-acre yields, which averaged 

approximately 336 CWT per acre in 2012 have increased at least by seven-fold since the early 

1900s and have doubled since the early 1960s. 

Potato is grown in all 48 of the continental U.S. states with production concentrated in the 

states of Colorado, Idaho, Minnesota, North Dakota, Washington and Wisconsin accounting for 

approximately 75% of annual production (USDA-NASS, 2013). Idaho and Washington, the two 

top potato producing states, typically account for slightly more than one-third of the total U.S. 

crop (USDA-ERS, 2011). In recent years, the bulk of potato production in the U.S. has shifted 

from the East and Midwest to the Northwest because of transportation system improvements, 

decline in consumption of fi·esh potatoes, changes in weather pattems, and advantageous power, 

tax, and labor costs (Guenther, 201 0). 

The average American consumes about 115 lb of potato annually, of which about two-thirds is 

consumed as processed potato products (USDA-ERS, 2010). Different potato varieties have 

been selected for performance in tl1e fresh and processed markets. Russet varieties store well 

and are the source of most fi·esh market potatoes and French fries, while the Atlantic variety 

does not store well and is used primarily to produce potato chips (Simplot, 2013a). 

After China, India, Russia, and the Ukraine, the United States is the fifth largest potato 

producing country (FAO, 2013), with annual production over the last three years ofbetween 
A detennination ofnonregulated status oflnnateTM potato is not expected to directly cause an 

increase in agricultural acreage devoted to potato production. The availability of l!mateTM potato 

will not change cultivation areas for potato production in the U.S. and there are no anticipated 

changes to the availability other potato varieties on the market. 

Intensity- Intensity is a measure of the degree or severity of an impact based upon the ten 

factors. The following factors were used as a basis for this decision: 

1. Impacts that may be both beneficial and adverse. 

Public health concerns associated with the use ofGE potato, such as InnateTM potato, and 

GE potato products focus primarily on human and animal (livestock) consumption of GE 

food and feed commodities. 

A determination ofnonregulated status ofl!mateTM potato will have no significant 

environmental impact in relation to the availability of GE, conventional, and organic 

potato varieties. As discussed in Chapter 4 of the EA, a determination of nonregulated 

status oflnnateTM potato is not expected to directly cause an increase in agricultural 

acreage devoted to potato production, or tl1ose potato acres devoted to GE potato 

cultivation. The availability oflnnateTM potato will not change the cultivation areas for 

potato production in the U.S. and there are no anticipated changes in the availability of 

GE and non-GE potato varieties on tl1e market. A determination ofnonregulated status 

oflnnateTM Potato could add another potato variety to the conventional potato market and 

is not expected to change tl1e market demands for GE potato or potato produced using 

organic methods. 

Based on data provided by Simplot for InnateTM potato (Simplot, 2013a), APHIS has 

concluded that the availability oflnnateTM potato would not alter the agronomic practices, 

locations, and seed production and quality characteristics of conventional and GE potato 

seed production (Simplot, 2013a). A determination ofnonregulated status oflnnateTM 

potato will not require a change to seed production practices, nor current production 

practices. 

2. The degree to which the proposed action affixts public health or safety. 
and regulatory requirements. GE organisms for food and feed may undergo a voluntary consultation process with the FDA prior to release onto the market. Although a voluntary 

process, thus far all applicants who have wished to commercialize a GE variety that 

would be included in the food supply have completed a consultation with the FDA. In 

such consultation, a developer who intends to commercialize a bioengineered food meets 

with the agency to identify and discuss relevant safety, nutritional, or other regulatory 

issues regarding the bioengineered food and then submits to FDA a summary of its 

scientific and regulatory assessment of the food. This process includes: I) an evaluation 

of the amino acid sequence introduced into the food crop to confirm whether the protein 

is related to !mown toxins and allergens; 2) an assessment ofthe protein's potential for 

digestion; and 3) an evaluation of the history of safe use in food (Hammond and Jez, 

2011 ). FDA evaluates the submission and responds to the developer by letter with any 

concerns it may have or additional information it may require. Several international 

agencies also review food safety associated with GE-derived food items, including the 

European Food Safety Agency (EFSA) and the Australia and New Zealand Food 

Standards Agency (ANZFS). Simp lot provided the FDA with information on the identity, 

function, and characterization of the genes for InnateTM potato, including expression of 

the gene products, on February 12, 2013. The FDA is currently reviewing Simplot's 

submission. 

A detennination ofnonregulated status ofhmateTM potato would have the potential to 

improve human health because of its lower acrylamide-fonning potential. Since 

acrylamide is not contained in raw potato, impacts to animal health would not be any 

different than effects iflnnateTM potato continues to be regulated. Other than lowered 

asparagine and PPO, and increased glutamine, hmateTM potato is compositionally similar 

to cunently available potato on the market. 

3. Unique characteristics o{the geographic area such as proximity to historic or cultural 

resources, park lands, prime farmlands, wetlands, ·wild and scenic rivers, or ecological(v 

critical areas. 

There are no unique characteristics of geographic areas such as park lands, prime farm 

lands, wetlands, wild and scenic areas, or ecologically critical areas that would adversely 

impacted by a detennination ofnonregulated status oflnnateTM potato. The common 

agricultural practices that would be carried out under the proposed action will not cause 

major ground disturbance; do not cause any physical destruction or damage to property, 
practices for land preparation, planting, irrigation, and harvesting of plants would be used 

on agricultural lands planted to InnateTM potato including the use of EPA registered 

pesticides. Applicant's adherence to EPA label use restrictions for all pesticides will 

mitigate potential impacts to the human environment. In the event of a determination of 

nonregulated status of InnateTM potato, the action is not likely to affect historic or cultural 

resources, park lands, prime fannlands, wetlands, wild and scenic rivers, or ecologically 

critical areas that may be in close proximity to potato production sites. 

4. The degree to which the effects on the quality of the human environment are likely to be 

highZJl controversial. 

The effects on the quality of tl1e human environment from a determination of 

nonregulated status ofirmateTM potato are not highly controversial. Although there is 

some opposition to a detennination of nonregulated status of InnateTM potato, this action 

is not highly controversial in tenus of size, nature or effect on the natural or physical 

environment. As discussed in Chapter 4 of the EA, a detennination of nonregulated 

status is not expected to directly cause an increase in agricultural acreage devoted to 

potato production. The availability ofinnateTM potato will not change cultivation areas 

for potato production in the U.S., and there are no anticipated changes to the availability 

of potato varieties on the market. A determination ofnonregulated status ofl!mateTM 

potato could add anotl1er potato variety to the potato market and is not expected to 

change the market demands for potato produced using organic methods. A dete1mination 

of nonregulated status ofinnateTM potato will not result in changes in the cun·ent 

practices of planting, tillage, fertilizer application/use, cultivation, pesticide application 

use/volunteer control. Management practices and seed standards for production of 

certified potato seed would not change. The effect ofinnateTM potato on wildlife or 

biodiversity is not different than that of crops cunently used in agriculture, or other 

potato produced in conventional agriculture in the U.S. During the public comment 

period, APHIS received comments opposing a determination of nonregulated status of 

InnateTM potato. No new issues, alternatives or substantive new infonnation were 

identified in any of the comments received by APHIS. APHIS has addressed substantive 

comments in the response to public comments document attached to this FONSI based on 

scientific evidence found in peer-reviewed, scholarly, and scientific journals. 

5. The degree to which the possible effects on the human environment are highly uncertain 

or involve unique or unlawwn risks. 
potato will not result in changes in the current practices of planting, tillage, fertilizer 

application/use, and volunteer control. Management practices and seed standards for 

production of certified potato seed would not change. The effect of InnateTM potato on 

wildlife or biodiversity is no different than that from other crops currently used in 

agriculture, or other potato produced in conventional agriculture in the U.S. As described 

in Chapter 2 of the EA, well established management practices, production controls, and 

production practices (GE, conventional, and organic) are currently being used in potato 

production systems (commercial and seed production) in the U.S. Therefore, it is 

reasonable to assume that fanners, who produce conventional potato varieties, InnateTM 

potato, or produce potato using organic methods, will continue to use tl1ese reasonable, 

commonly accepted best management practices for their chosen systems and varieties 

during agricultural potato production. 

6. The degree to which the action may establish a precedentfor.fitture actions with 

significant effects or represents a decision in principle about a.fitture consideration. 

A determination ofnonregulated status for InnateTM potato would not establish a 

precedent for future actions with significant effects or represent a decision in principle 

about a future decision. Similar to past regulatory requests reviewed and approved by 

APHIS, a detennination of nonregulated status will be based on whether an organism is 

unlikely to pose a plant pest risk pursuant to the regulatory requirements of 7 CFR part 

340. Each petition that APHIS receives is specific to a particular GE organism and 

undergoes this independent review to detennine if the regulated article poses a plant pest 

risk. Under the authority of the plant pest provisions of the Plant Protection Act and 7 

CFR part 340, APHIS has issued regulations for the safe development and use of GE 

organisms. As required by 7 CFR 340.6, APHIS must respond to petitioners who request 

a determination of the regulated status of GE organisms, including GE plants such as 

InnateTM potato. When a petition for nonregulated status is submitted, APHIS must make 

a detennination if the GE organism is unlikely to pose a plant pest risk. If APHIS 

determines based on its Plant Pest Risk Assessment that the genetically engineered 

organism is unlikely to pose a plant pest risk, the genetically engineered organism is no 

longer subject to the plant pest provisions of the Plant Protection Act and 7 CFR part 340. 

APHIS regulations at 7 CFR part 340, which were promulgated pursuant to authority 

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

7772), regulate the introduction (importation, interstate movement, or release into the 
also regulated under Part 340 when APHIS has reason to believe that the GE organism 

may be a plant pest or APHIS does not have enough infonnation to determine if the GE 

organism is unlikely to pose a plant pest risk. A person may petition the agency that a 

particular regulated article is unlikely to pose a plant pest risk, and, therefore, is no longer 

regulated under the plant pest provisions of the Plant Protection Act or the regulations at 

7 CFR part 340. The petitioner is required to provide infonnation under §340.6(c) (4) 

related to plant pest risk that the agency may use to determine whether the regulated 

article is unlikely to present a greater plant pest risk than the umnodified organism. A 

GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the 

plant pest provisions of the Plant Protection Act when APHIS detennines that it is 

unlikely to pose a plant pest risk. 

7. Ff/hether the action is related to other actions with individualZv insignificant but 

cumulativeZv significant impacts. 

No significant adverse cumulative effects were identified through this environmental 

assessment. Human health effects of consuming cooked InnateTM potato are expected to 

be positive. A cumulative effects analysis is provided in Chapter 5 of the EA. In the 

event APHIS reaches a detennination ofnonregulated status oflnnateTM potato, APHIS 

would no longer have regulatory authority over this potato. In the event of a 

detennination ofnonregulated status ofinnateTM potato, APHIS has not identified any 

significant impact on the environment which may result from the incremental impact of a 

determination of nonregulated status oflnnateTM potato when added to past, present, and 

reasonably foreseeable future actions. 

8. The degree to which the action may adversely affect districts, sites. highways, structures. 

or objects listed in or eligible for listing in the National Register of Historic Places or 

may cause loss or destruction of significant scientific, cultural, or historic resources. 

A detennination ofnonregulated status ofinnateTM potato will not adversely impact 

cultural resources on tribal properties. Any fanning activities that may be taken by 

fanners on tribal lands are only conducted at the tribe's request; thus, the tribes have 

control over any potential conflict with cultural resources on tribal properties. A 

detennination of nonregulated stah1s oflnnateTM potato would have no impact on 

districts, sites, highways, structures, or objects listed in or eligible for listing in the 

National Register of Historic Places, nor would they likely cause any loss or destruction 
undertaking that may directly or indirectly cause alteration in the character or use of 

historic properties protected under tl1e National Historic Preservation Act. In general, 

common agricultural activities conducted under tl1is action do not have the potential to 

introduce visual, atmospheric, or audible elements to areas in which they are used that 

could result in effects on the use and enjoyment of a historic property when common 

agricultural activities conducted under tl1is action do not have the potential to introduce 

visual, atmospheric, or audible elements to areas in which they are used that could results 

in effects on the character or use of historic properties. For example, tl1ere is potential for 

audible effects on the use and enjoyment of a historic property when cmmnon 

agricultural practices, such as the operation of tractors and other mechanical equipment, 

are conducted close to such sites. A built-in mitigating factor for this issue is tl1at 

virtually all of the methods involved would only have temporary effects on the audible 

nature of a site and can be ended at any time to restore the audible qualities of such sites 

to their original condition with no further adverse effects. Additionally, these cultivation 

practices are already being conducted throughout the potato production regions. The 

cultivation oflimateTM potato does not inherently change any oftl1ese agronomic 

practices so as to give rise to an impact under the NHP A. 

9. The degree to which the action may adversely affect the endangered or threatened 

species or its habitat that has been determined to be critical under the Endangered 

Species Act ofl973. 

As described in Chapter 4 of the EA, APHIS has analyzed the potential for effects from a 

determination ofnonregulated status oflnnateTM potato on federally listed threatened and 

endangered species (TES) and species proposed for listing, as well as designated critical 

habitat and habitat proposed for designation, as required under Section 7 of the 

Endangered Species Act. After reviewing possible effects of a detennination of 

nonregulated status oflnnateTM potato, APHIS has determined that a detennination of nonregulated status oflnnateTM potato would have no effect on Federally listed TES and 

species proposed for listing, or on designated critical habitat or habitat proposed for 

designation. 

I 0. Whether the action threatens a violation of Federal, State, or local law or requirements 

imposedfor the protection of the environment. 
implementation of this action. 

NEPA Decision and Rationale 

I have carefully reviewed the EA prepared for this NEP A detennination and the input from the 

public involvement process. I believe that the issues identified in the EA are best addressed by 

selecting Altemative 2 (Determination that ImmteTM potato is No Longer a Regulated Article). 

This altemative meets APHIS' purpose and need to allow the safe development and use of 

genetically engineered organisms consistent with the plant pest provisions of the Plant Protection 

Act. 

As stated in the CEQ regulations, "the agency's prefened altemative is the altemative which the 

agency believes would fulfill its statutmy mission and responsibilities, giving consideration to 

economic, environmental, teclmical and other factors." The prefened altemative has been 

selected for implementation based on consideration of a number of enviromnental, regulatory, 

and social factors. Based upon our evaluation and analysis, Altemative 2 is selected because (I) 

it allows APHIS to fulfill its statutory mission to protect America's agriculture and environment 

using a science-based regulatory framework that allows for the safe development and use of 

genetically engineered organisms; and (2) it allows APHIS to fulfill its regulatory obligations. 

As APHIS has not identified any plant pest risks associated with Im1ateTM potato, the continued 

regulated status oflm1ateTM potato would be inconsistent with the plant pest provisions of the 

PP A, the regulations codified at 7 CFR part 340, and the biotechnology regulatory policies in the 

Coordinated Framework. For the reasons stated above, I have determined that a determination of 

nonregulated status of InnateTM potato will not have any significant enviromnental effects. 

Michael J. Firko, Ph.D. 

APHIS Deputy Administrator 

Biotechnology Regulatory Services 

Animal and Plant Health Inspection Service 

U.S. Department of Agriculture 

Date 
at http://www .regulations.gov/#! docketBrowser;rpp=25 ;po=O:dct=PS ;D=AP HIS-2012-0067-

0001. 

APHIS received a total of 308 submissions to the docket from various individuals and groups on 

the Simp lot potato petition. Eighty-five public comments supported a detennination of 

nonregulated status oflnnateTM potato, including submissions from universities, growers, trade 

associations, growers' associations, and private individuals. Conunents supporting the 

detennination of nonregulated status included the following areas: 

e Innate TM potato will be healthier, safer, and more nutritious for consumers. 

e Because of its reduced black spot bruising potential, InnateTM potato will reduce potato 

wastage, and therefore, increase efficiency for the potato industry. 

e Using native potato genes for genetic engineering greatly reduces ecological and 

evolutionary risks. 

e InnateTM potato is a better quality potato, with improved texture and taste. 

c InnateTM potato production can reduce use of fertilizers and pesticides. 

e InnateTM potato can reduce potato production costs. 

e Gene silencing teclmology is safe. 

e InnateTM technology will help accelerate potato development and improvement, including 

disease resistance. 

e Innate TM teclmology represents a significant improvement over conventional breeding 

teclmiques, especially when those techniques fail to eliminate negative traits. 

e InnateTM potato can be safely stored and shipped separate from conventional potatoes. 

e InnateTM potato will enhance global food security. 

e InnateTM potato has no potential for weediness and clonal propagation is an effective 

barrier to gene flow in potato. 

e There is no evidence that GE crops are unsafe, even after years of use. 

The docket received 223 public comments opposing a detennination of nonregulated status of 

l!mateTM potato. These comments included submissions from private individuals, and from two 

nongovenm1ental organizations (NGOs). One of the comments was a letter with 41,745 

signatures. The majority of the comments broadly opposed the development ofGE crops and the 

domestic regulatory process smTounding GE plants, as well as perceived negative effects on 

public and animal health, biodiversity, and the environment; and the public right to choose non-

'Hyperlink cannot be directly opened. The hyperlink must be pasted in web browser address bar to be functional. 
enzyme may result in unintended effects on plant fitness. 

e RNAi teclmology may have unintended results. 

• There is potential for hybridization of InnateTM potato with wild potato species, as well as 

potential contamination of conventional potatoes with InnateTM potato. 

On May 30, 2014, APHIS published a notice in the Federal Register (78 FR 31080-31082, 

Docket no. APHIS-2012-0067) mmouncing the availability of the Simplot InnateTM potato draft 

EA (13-022-0lp) and draft PPRA for a 30-daypublic review and comment period. Comments 

were required to be received on or before June 30,2014. The docket folder containing the 

comments cm1 be located at 

http://www.regulations.gov/#!docketBrowser;rpp=25;po=O;dct=SR;D=APHIS-2012-0067 A total of 60 public comments were received subsequent to the draft EA publication. The 

majority of those public comments supported the detennination of nonregulated status; however, 

some public comments did not support the determination of nonregulated status. Supporting 

commenters included individuals from 7 different universities, three trade associations, one 

industry organization, and I 0 farmers. 

Comments supporting the determination of nonregulated status included the following new 

1ssues: 

1 1 TM I d . . d . nnate potato may ea to an mcrease m exporte potatoes. 

2. Innate 1u potato ·will be marketed to other countries through and excellence in 

stewardship program. 

3. It is inconsistent to approve some genetically modified crops such as corn and soybean, 

and not potato. 

4. APHIS has experience reviewing crops genetica!Zv modified through RNA silencing. A 

commenter from a university stated that "APHIS has over 20 years of experience 

conducting risk assessments on GE plm1ts modified to exhibit a desired trait that relies 

upon an RNAi mechanism. The risk assessment parameters and methodologies APHIS 

used to evaluate these earlier products are entirely appropriate for the InnateTM potatoes." 

Of the public comments which opposed nonregulation ofirmateTM potato, the majority of these 

public comments did not explain or identify elements in the InnateTM potato PPRA or EA that 

were perceived to be inadequate or provide any supporting evidence for their claims. 
Issues related to the IllilateTM potato EA were organized into categories and addressed below. 

Issue 1: Four commenters askedfor a 90-day public comment extension. They stated that there 

was insufficient time to adequately review the EA. given that growers are currently busy 

managing crops. 

APHIS Response: 

APHIS deemed the 30-day comment period sufficient opportunity for the public to provide 

meaningful conm1ents on this EA. Following the commet period, the Agency thoroughly 

reviewed the comments and carefully considered other inputs as it prepared APHIS' EA, FONSI, 

and regulatory determination in response to this petition for nonregulated status ofinnate TM 

potato. 

Issue 2: A commenterfi·om an NGO stated that if InnateTM potato has reduced aclylamide, this 

may actual(v encourage more consumer demand.for.fi-ied potato products, with the overall effect 

of no to human health. 

APHIS Response: APHIS disagrees with this comment. Simp lot's compositional testing have shown that 

acrylamide is reduced, on average, 58-72% in InnateTM potato, compared with conventional 

potato (NTP, 2011; Simplot, 2013a). Potato chips and fried potato products represent only about 

1/3 of a human's dietary exposure to acrylamide (Chawla et al., 2012). Section 2.4.1 of the EA, 

Human Health, describes several other exposure routes of humans to acrylamide, including 

bread, biscuits, gingerbread, coffee, and smoking (Friedman, 2003; Chawla et al., 2012; Kotsiou 

eta!., 2013). 

As noted in Section 4.6.1 of the EA, Human Health, concerns over acrylamide safety may lead to 

processor preference for Simp lot InnateTM potato in French fries and other frozen potato 

products. There are no data suggesting that consumer preferences for fried potato products will 

increase if a determination of nonregulation is reached for Innate TM potato. 

Issue 3: An EIS is needed. A comment by an NGO stated that APHIS' NEP A analysis is 

inadequate because it does not take a "hard look at the environmental consequences "of the 

proposed action. The comment stated that the EA does not ensure "comprehensive, timely, and 

transparent enviromnental review of agency action." 
possible environmental impacts of the proposed action, and is satisfied that the EA developed for 

the proposed deregulation of the InnateTM potato is adequate and sufficient. Additionally, 

APHIS' analysis and decision in the PPRA regarding the potential, if any, plant pest tisk posed 

by the InnateTM potato is based on the best available scientific and technical information. APHIS 

used sound science to infonn its regulatory decision regarding the plant pest risk of the InnateTM 

potato, and has concluded that the InnateTM potato is unlikely to pose a plant pest risk. APHIS 

carefully reviewed the infonnation provided by the petitioner and others and considered all other 

relevant information sufficient to make the determination on the regulated status oflnnateTM 

potato. 

In the EA, APHIS has made sure to consider and evaluate opposing and/or contrary views; it has 

reviewed data submitted by those who supported or opposed the detennination of nonregulated 

status, and has made sure to use objective, reliable environmental and scientific 

infonnation. APHIS has included an analysis of each of the alternatives and evaluated and used 

the best available infonnation from various sources, including peer-reviewed scientific literature 

that was reviewed and incorporated into APHIS' analysis. APHIS relied on a variety of 

trustworthy sources to support its analysis of the potential impacts of a detennination of 

nonregulated status for ItmateTM potato. These sources include, but are not limited to the Simplot 

petition, technical reports, and peer-reviewed literature. 

The EA has been prepared in order to specifically evaluate the potential effects on the quality of 

the human environment that may result from a detennination of nonregulated status oflnnate TM 

Potato. APHIS assembled a list of alternatives that might be considered for detennining whether 

or not the InnateTM Potato should be given non-regulated status. The agency evaluated these 

altematives, in light of the agency's statutory authority under the plant pest provisions of the 

Plant Protection Act, and the regulations at 7 CFR part 340, with respect to environmental safety, 

efficacy, and practicality to identify which altematives would be the appropriate ones to consider 

in reference to making a decision on whether to deregulate the hmaten1 potato. As described in 

the EA, APHIS evaluated two altematives; (I) no action and (2) detennination of nonregulated 

status of InnateTM potato. In addition, APHIS rejected several other altematives. These 

altematives are discussed briefly in Chapter 3 of the EA along with the specific reasons for 

rejecting each. 

APHIS has prepared the EA to specifically evaluate the potential effects on the quality of the 

human environment that may result from the deregulation of InnateTM potato. The 

environmental analysis in the EA has not indicated that any significant impacts on the 

enviromnent would result from the deregulation and therefore, APHIS does not need to prepare 

an EIS for this proposed action. 
APHIS disagrees with the comment. The Simplot petition (13-022-0lp) for dete1mination of 

nonregulated status and PPRA were published in the Federal Register on May 3, 2013 (78 FR 

25942-25943, Docket no. APHIS-2012-0067), and the EA was published in the Federal Register 

on May 30, 2014 (78 FR 31080-31082, Docket no. APHIS-2012-0067) mmouncing the 

availability of the Simp lot InnateTM potato draft EA. APHIS routinely seeks public participation 

thru the Federal Register as the official method of notifying the public of regulatory actions. The 

60 day notice of the petition and PPRA and the 30 day comment period for this EA allowed for 

aJUp!e public participation. This proven method rendered over 300 comments including a letter 

with over 41,000 signatures. 

Issue 5: APHIS needs to provide a valid purpose and needfor approving GE potatoes. A 

comment from an NGO stated that APHIS needs to define the purpose of the action, and APHIS' 

statement in the EA that it "must respond to petitioners that request a determination of the 

regulated status of GE organisms" is not sufficient: "the purpose and need of a proposed action is 

not just the agency is considering the action; rather, the pmpose and need statement must 

actually describe the underlying purpose and need for the proposed action". The commenter 

asserts that APHIS needs to "identify a purpose and/or need for approving deregulation of the 

GE potatoes", and "describe why either facilitating more consumption of potatoes or reducing 

visible signs of damage (i.e., browning) is a compelling enough problem." 

APHIS Response: 

As mentioned in Section 1.1 of the EA, a person may petition the agency for a determination that 

a particular regulated article is unlikely to pose a plant pest risk, and therefore, is no longer 

regulated under the plant pest provisions of the PP A or the regulations at 7 CFR 340. Under § 

340.6(c)(4), the petitioner must provide infonuation related to plant pest risk that the agency cm1 

use to detenuine whether the regulated article is unlikely to present a greater plant pest risk than 

the unmodified organism. APHIS must respond to petitioners that request a detenuination of the 

regulated status of GE organisms (7 CFR 340.6), including GE plants such as Simplot InnateTM 

potato. When a petition for nonregulated status is submitted, APHIS must detenuine if the GE 

organism is unlikely to pose a plant pest risk. 

APHIS does not have the regulatory authority to evaluate the efficacy of a petitioner's product, 

nor the need for the product. 
breeding non-GE potato varieties with lower susceptibility to browning or with lower acrylamide 

potential. The commenter refers to a guidance document from FDA which suggests that 

conventional breeding has "shown promise" in reducing acrylan1ide potential. The commenter 

lists several other alternatives such as assessing sugar levels in potatoes coming into processors, 

managing storage conditions to control sprouting, and handling potatoes gently during harvest, 

transport, and delivery. 

APHIS Response: 

APHIS disagrees with this comment. The commenter suggested alternatives that are not within 

the range of alternatives that reasonably needed to be considered. Those suggested alternatives 

are neither economical nor practical. Therefore, APHIS did not evaluate these alternatives 

because they are outside the scope ofthis EA. The analysis presented for each of the alternatives 

within this EA provides the agency decisiomnaker and the public with as full a picture as 

practicable of the effects of it determination. The agency believes the analysis of these 

alternatives in this EA provides the decisiomnaker and public with the impacts of each of these 

alternatives and differences in environmental impacts that would result. Even so, in the end, the 

analysis contained in tllis EA does not expand the agency's authority or impose a duty to select 

what some view as the most enviromnentally friendly result. This decision does not prevent 

potato processors from choosing the method to prevent browning that they wish to employ. The 

EA has been prepared in order to specifically evaluate the potential effects on the quality of the 

hnman enviromnent tl1at may result from a determination of nonregulated status of Im1ate TM 

potato. 

As discussed in Section 2.1 of the EA, Agricultural Production and Agronomic Practices of 

Potato, Potato Breeding, potato breeding by conventional methods is very difficult and timeconsuming and may talce years to successfully introduce as single trait. InnateTM potato uses a 

single construct to transfonn 5 different commercial parent varieties and create I 0 events 

(USDA-APHIS, 2013a). The objective oflnnateTM potato was to incorporate the same new 

phenotypes into each of these important varieties, while maintaining all of the desirable 

characteristics originally selected by potato breeders. If a single variety was transfonned, it 

would take decades to move tl1ese new traits into the other commercial varieties by conventional 

breeding, and even then, it would be difficult to reconstitute tl1e desirable characteristics of the 

original variety. 
Issue 7: APHIS did not ''properly" consider cumulative impacts. A comment from an NGO 

stated that the cumulative impacts section in the EA did not have enough quantitative data or 

detailed infonnation, and was too general. In particular, the commenter asserted that APHIS 

"does not account for the fact that Simp lot has stated its intention to cross these potatoes with 

other varieties, and to introduce other GE potatoes." The commenter further stated that APHIS 

did not consider the potential for hanns introduced by the deregulation of Innate TM potato to 

adversely affect nontarget organisms such as pollinators and on the potato market. In particular, 

the commenter states that APHIS should consider cumulative impacts on "consumer 

preferences." The commenter states that APHIS needs to consider socioeconomic impacts and 

the cumulative effects of "possible increased pesticide use as a result of the GE potatoes," as 

well as the "pathogen-resistance effects of Simplot's genetic engineering." The commenter 

concluded that an EIS is needed for these reasons. 

APHIS Response: 

APHIS disagrees with the commenter. Section 5.1 of the EA, Assumptions Used for Cumulative 

Impacts Analysis, discusses this issue. The cumulative effects analysis is focused on the 

incremental impacts of the Preferred Alternative taken in consideration with related activities 

including past, present and reasonably foreseeable future actions. In this analysis, if there are no 

direct or indirect impacts identified by a resource area, then APHIS assumes there can be no 

cumulative impacts. 

With regard to the commenter's concern that APHIS did not evaluate the cumulative effects of 

Simplot's stated objective of crossing Innate TM potato with other potato varieties, because 

APHIS has determined that InnateTM potato is not a plant pest risk (USDA-APHIS, 2013a), by 

definition, any progeny resulting from crosses between InnateTMand conventional potato 

varieties will not be a plant pest risk. Simplot ItmateTM potato is agronomically and 

compositionally similar to other potato cultivars (USDA-APHIS, 2013a). 

The commenter misstates our regulatory process. If Simp lot introduces other GE potatoes, those 

potatoes will have to undergo the same regulatory process as Innate TM potato. In other words, a 

new Simplot GE potato would be evaluated under 7 CFR part 340. 

The commenter recommends that APHIS consider the cumulative impacts oflnnate TM potato on 

consumer preferences. There are no data available to suggest that determination of nonregulated 

status will alter consumer preferences. 
decrease pesticide use. EPA regulates the use of pesticides under FIFRA. EPA sets the 

conditions for pesticide use on the label to achieve a standard of a "reasonable certainty of no 

harm." Therefore, the impact of pesticide use is outside the scope of this EA. 

The "pathogen-resistance effects" oflnnateTM potato was also raised by the commenter as a 

potential cumulative effect not evaluated by APHIS. This issue is covered in the APHIS 

Response to Issue II, below. 

Issue 8: APHIS did not "adequately" consider socioeconomic impacts. The commenter stated 

that APHIS must consider "past contamination episodes from GE crops" in its analysis. The 

commenter further stated that contamination of conventional potatoes with InnateTM potato could 

adversely affect foreign markets. The commenter concluded that APHIS must prepare an EIS to 

analyze the potential for contamination prior to deregulation. 

APHIS Response: 

APHIS has considered the past contamination episodes from GE crops. Specifically for GE 

potato, it is difficult to commingle a crop of its size. Furthermore, potato is asexually propagated 

so it doesn't have cross pollinations issues like other crops. Therefore it is relatively easy to 

identity preserve potato. 

APHIS discussed socioeconomic impacts in Section 4.7 of the EA, Socioeconomic Impacts. 

Because of the reduced black spot bruise potential ofSimplot limateTM potato, it is expected that 

wastage will decrease significantly, and therefore, revenues will increase. Overall, if APHIS 

chooses the Preferred Alternative, the introduction of Simplot limateTM events are likely to have 

positive economic impacts. Potatoes with low acrylamide and reduced black spot bruise 

potential 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. 

Issue 9: APHIS did not adequately consider transboundwy impacts. A comment from an NGO 

stated that APHIS did not consider the effect of a determination of nonregulated status of 

Itmate TM potato on other nations. The conunenter specifically cited Canada because "much of 

the U.S. potato industry is in northern states." The commenter also stated that relying on 

voluntary grower agreements, isolation distances and processor requirements is not sufficient. 

APHIS Response: 
f

f 

determination ofnonregulated status. A comment from an NGO disagreed with Simplot's data 

conclusions with regard to susceptibility to pathogens. The commenter stated that Simp lot 

should have performed pathogen challenge tests on its potatoes to address this issue. The 

commenter also noted that if gene silencing is incomplete in leaves, an intennediate phenotype 

which is more susceptible to pathogens might occur. The commenter stated that if disease 

susceptibility is increased, this could lead to increased use of pesticides to control the diseases. 

APHIS Response: 

The literature contains large numbers of publications discussing the metabolic pathway ofPPO 

(polyphenol oxidase), including nine which have been referenced in this EA (Felton eta!., 1989; 

Steffens, 1994; Martinez and Whitaker, 1995; Friedman, 1997; Yoruk and Marshall, 2003; 

Mayer, 2006; Stremmel eta!., 201 0; Tran eta!., 2012; Navarre et al., 2013). The metabolic 

pathway has, therefore, been well studied. APHIS' response to the above comment describes 

research conducted to date on function ofPPO. 

As discussed in the PPRA (USDA-APHIS, 2013a) and in Section 4.5.1 ofthe EA, Animal 

Communities, the biological function ofPPO in plants has not been conclusively detennined 

(Mayer, 2006), although there are suggestive data that the oxidation products ofPPO appear to 

play a role in general plant defense mechanisms against pathogens and pests. Phenolics can 

inhibit the growth of specific pathogens and can also inhibit enzymes involved in pathogenesis 

(Lyon, 1989). Researchers have studied the effect of phenols on disease resistance (e.g., (Lyon, 

1989; Kroner and Mamet, 2012) but have no proof that phenols are impmtant mediators of 

interactions between potato and disease organisms. 

The issue of the relationship between PPO and resistance to herbivores was discussed in the 

PPRA (USDA-APHIS, 2013a). Although trichomes in some plants produce defensive 

compounds involving PPO in response to insect attack, the trichomes of cultivated potatoes 

contain low amounts of PPO which is not thought to be involved resistance to pests (Friedman, 

1997). 

With regard to the comment that Simplot should have perfonned assays challenging hmate TM 

potato with pathogens, Simplot did this (Simplot, 2013a). As described in the petition, disease 

susceptibility was evaluated by intentionally infecting the events and their untransfonned 

controls with late blight and soft rot, and results confirmed that silencing of the target genes did 

not enhance susceptibility to disease. 
controls in stress due to early blight. There were few observations for late blight (P. il?{estans), 

and no observations were systematically collected for Fusarium dry rot (Fusarium spp.), ring rot 

( Clavibacter michiganensis spp. sepedonicus), and water rot!Pythium leak (Pythium ultimum ). 

However, there were no significant differences between events J3, J55, J78, H37, and H50 and 

their controls in the number of tubers discarded at harvest due to quality issues, i.e. rot or mold, 

while the number of tubers discarded for event G II was significantly lower than its control 

(Simplot, 2013a), Appendix 6. Discards for Events FlO, F37, El2 and E24 were not recorded. 

During the cold storage period for trials in three locations in either 2009 or 2010, pink rot 

(Phytophthora e!ythroseptica) and soft rot and Pythium leak diseases were occasionally 

observed on both untransfonned and unspecified InnateTM potato events, but no data were 

provided, and the disease incidence was attributed to environmental soil conditions that favored 

infection (Simp lot, 2013a). While a number of viruses also affect tubers (e.g., potato leaf roll 

virus), these also have above-ground symptoms and such symptoms were not observed during 

the field trials. Based on analyses of results presented in the petition (Simplot, 2013a), the PPRA 

(USDA-APHIS, 2013a) concluded that limateTM potato is unlikely to be more susceptible than 

control potatoes to diseases such as late blight or tuber rot. 

Simp lot evaluated how Innate TM potato performed in the field with respect to control potatoes 

(Appendix 6). Pest and disease characteristics were monitored, and data were collected that 

would help to analyze if these events were less, equal, or more susceptible to pest and diseases 

than control potatoes (Simplot, 2013a). IfPPO were involved in pest and disease resistance, 

through a role in the hypersensitivity response, then one might expect a systematic increase in 

the sensitivity of PPO suppressed Innate TM potato to a wide variety of agents. Simplot did not 

observe such a change in phenotype in their field observation oflnnate TM potato (Simp lot, 

2013a). Standard agronomic practices were sufficient to prevent pests and diseases in InnateTM 

potato and no additional control measures were required (Simplot, 2013a). InnateTM potato is 

expected to be no more susceptible to the same plant patl1ogens and insect pests as the 

conventional potato varieties (USDA-APHIS, 2013a). Standard field agronomic practices will 

be used to control for disease and pests in Im1ateTM potato as they would in non-GE potato fields. 

Issue 11: Concern that silencing o.f asnl genes could have some unintended adverse effects. 

This comment was made by an NGO. 

APHIS Response: 
based crossing of closely related species- and far less likely than methods such as ionizing 

radiation and chemical mutagenesis, which are not subject to regulation and are not excluded 

methods under the NOP (Sciences, 2004). 

Data on performance oflnnateTM potato from Simplot's petition (Simplot, 2013a) indicates that 

there are no statistically significant differences from perfonnance of conventional potatoes. 

Although total nitrogen was not measured, APHIS would have expected plant growth 

performance to have suffered if asparagine levels were so depressed that nitrogen transport and 

storage was negatively affected. 

Issue 12: Yield data results are inconclusive. A comment from an NGO stated that Simplot's 

field trials data showed that 50% of the tJial yields were significantly lower than control yields. 

The cormnenter also stated that "high yield is typically one of the most important characteristics 

of crop varieties that farmers look for, because it tends to result in higher profits." 

APHIS Response: APHIS does not regulate the actions of individual market participants. 

Farmers can choose to either use or not use the lower yielding potatoes. Those decisions rest 

solely on market participants and are outside APHIS regulatory autl10rity. 

Issue 13: APHIS' scientific analysis and data are "incomplete and inadequate." A comment 

from an NGO stated that because of uncertainty, APHIS' analyses are deficient, and APHIS 

should collect their own data, especially on nutritional composition and RNAi effects. 

APHIS Response: 

APHIS disagrees that its scientific analysis and data are incomplete and inadequate. APHIS' 

analysis and decision within the PPRA regarding the plant pest risk posed by l!mateTM potato is 

based on the best available scientific and technical information. APHIS used sound science to 

infonn its regulatory decision regarding the plant pest risk of Innate TM potato, and has concluded 

that l!mateTM potato is unlikely to pose a plant pest risk. APHIS carefully reviewed the 

infonnation provided by the petitioner and others and considered all other relevant infonnation 

sufficient to make the determination on the regulated status oflnnate TM potato. APHIS carefully 

considered the possible enviromnental impacts of the proposed product, and is satisfied that the 

EA developed for Innate TM potato is adequate and sufficient. 

In the EA, APHIS has considered opposing views, has reviewed data submitted by those who 

supported or opposed the determination of nonregulated status, and has not relied on biased 
As an example of the safety and data analysis ofGE crops, Ricroch (Ricroch, 2013) examined 

data from animal feeding studies and 60 recent GE vs. non-GE crop lines comparisons, including 

33 long-tenn animal feeding studies, 16 of which spanned multiple generations. The 

comparisons showed that GE transformation has less impact on plant expression and 

composition than does conventional plant breeding. Ricroch (Ricroch, 2013) noted that no new 

safety concerns raised in any of the feeding studies, including the multigenerational studies and 

long-tenn studies. 

Similarly, Snell (Snell eta!., 2012) reviewed data from 12 long-tenn animal feeding studies 

(including GE potato, although not these traits) of durations >90 days to up to 2 years, and 12 

multigenerational studies (from 2 to 5 generations). No statistically significant differences were 

observed on animal health parameters when compared with control animals. 

With regard to the comment about safety of RNAi, RNA interference (RNAi) is an RNA-based 

mechanism that changes endogenous gene expression in eukaryotes including plants, insects, 

fungi, nematodes, and mammals. RNAi-mediated gene suppression generally requires sequence 

homology of at least 90% between the silencing construct and the target sequence to be 

successful and even higher degrees of homology over 21-23 nucleotide stretches (Sharp, 200la). 

A complementarity between siRNAs (short interfering RNA) and their target RNA sequences is 

necessary for an effective and efficient gene silencing. Short interfering RNA-mediated silencing 

of non-target genes, tenned off-target effects (OTE), often appears to be caused by silencing 

genes homo logs to the targeted gene and/or other genes shming partial sequence complementarity or similarity to the siRNA (Jackson eta!., 2003). 

The potential unintended effects in biotech crops (e.g., compositional or agronomic changes) are 

importm1t factors in the evaluation of crop safety assessment process (Cellini eta!., 2004). RNAi 

induced changes could be manifested in compositional or phenotypic changes in the genetically 

modified plant (Parrott eta!., 2010). 

According to a recent publication, (Petrick eta!., 2013), GE crops utilizing RNA-mediated 

technology, including RNAi, are safe for human and animal consumption. Nucleic acids are 

natural components of all foods m1d feeds and presumed to be safe based on long history of past 

consumption. RNAi mediated gene suppression generally requires sequence homology of at 

least 90% between the silencing construct and the target sequence to be successful and even 

higher degrees of homology over 21-23 nucleotide stretches (Sharp, 2001 b). It is not likely that 
scenarios are unlikely to lead to impacts to non-target predators and parasitic arthropods since 1) 

they may not receive effective doses, 2) intracellular amplification of siRNA, the active gene 

silencing component derived from dsRNA, is not widely found in insects, 3) environmental and 

physiological conditions in the gut may destroy the RNA, 4) and they may not have the 

appropriate receptors to allow transmembrane movement of dsRNA or the appropriate enzyme to 

direct RNAi (e.g. Dicer, Argonaute, RdRP, RNA and DNA helicases) (Lundgren and Duan, 

2013). 

There is no confirmed evidence in the scientific literature, that associates consumption of plantderived RNA molecules of any kind with any hazards in humans, other mammals, or 

domesticated animals" (Carrington, 2014). It is not likely that the gene silencing in the InnateTM 

events would contribute to silencing of other genes or offtarget affects. 

The PPRA (USDA-APHIS, 2013a) showed that there were no significant differences between 

any of the 10 InnateTM potato events and conventional potatoes for mean glycoalkaloid toxin 

content. No new proteins are expected to be produced based on the inserted genetic elements 

and the genetic modification. 

APHIS conducted a PPRA, and concluded that InnateTM potato does not constitute a plant pest 

risk (USDA-APHIS, 2013a). FDA regulates food safety of GE organisms under the authority of 

the FFDCA (21 U.S.C. 301 et seq.). 

Issue 14: APHIS did not adequately consider public health impacts. A comment from an NGO 

stated that APHIS improperly "passes the buck to FDA" on public health impacts. The 

commenter also criticized FDA's voluntary consultation process as "extraordinarily weak," and 

should not be relied upon by APHIS. The commenter further stated that APHIS did not evaluate 

the "direct and indirect potential side effects from changes in pathogen resistance likely caused 

by reducing browning." 

APHIS Response: 

In the EA, APHIS has considered opposing views, has reviewed data submitted by those who 

supported or opposed the detennination of nomegulated status, and has not relied on biased 

infonnation. APHIS has included an analysis of each of the alternatives and evaluated and used 

the best available information from various sources, including peer-reviewed scientific literature 

that was reviewed and incorporated into APHIS' analysis. APHIS relied on a variety of sources 

to support its analysis of the potential impacts of a detennination of nonregulated status for 
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every developer of a biotech crop has consulted with the FDA prior to market. 

During the first comment period, APHIS received 43 comments, including those from 3 growers' 

associations, 5 universities, and 3 agribusinesses, that Innate TM potato will be healthier than 

conventional potatoes. One commenter from a university stated that "the proposed modifications 

offer a simple method to reduce the levels of (acrylamide) in our food." Another commenter at another university asserted that "no novel proteins are produced, meaning there is no known 

biological mechanism whereby silencing these genes could increase weediness potential or 

provide a plant pest risk." A commenter from a third university stated: "The process results in 

potato lines that demonstrate reduced black spot bruise, low asparagine, and lower levels of 

reducing sugars. These are all traits that are critical to the potato industry and will reduce 

potential risk to humans consuming fried potato products." 

As discussed in Section 4.6.1 of the EA, Human Health, a decision to deregulate Innate TM potato 

should decrease exposure to acrylamide by between 58 and 72%, a significant reduction in a 

toxic compound (NTP, 2011; Simp lot, 2013a). Further, the data presented in the petition show 

that the Simp lot InnateTM potato events are at least as safe and nutritious for food as the 

untransformed controls (Simplot, 2013a). The compositional analyses of the ten events are 

summarized in the petition, with detailed results in Appendix 9 (Simplot, 2013a). 

Issue 15: APHIS did not consult with tribes. A comment from an NGO stated that "APHIS has 

made no showing in this EA to indicate that it has considered the potential impacts of this action 

upon tribes or whether it has sought out any input from tribal officials." 

APHIS Response: 

APHIS disagrees with this comment. Prior to the publication of this EA, APHIS sent a letter to 

tribal leaders in the continental United States on May 3'd, 2013. This letter contained 

infmmation regarding the JR Simplot Company petition and the InnateTM potato varieties. 

Additionally, this same notification also asked tribal leaders to contact APHIS if they believed 

that there were potentially significant impacts to tribal lands or resources that should be 

considered. No responses were received by APHIS from tribal leaders regarding the JR Simplot 

Company petition or InnateTM potato varieties. 

Furthermore, APHIS considered the impact to tribes or tribal properties in the EA (Section 7.6 

National Historic Preservation Act [NHP A J of 1966 as Amended) and this FONSI (Item 8 above, 
APHIS Response: 

Section 4.5.1 of the EA, Animal Cmmnunities, discusses projected effects oflm1ateTM potato on 

non-target animals. Consumption of Simp lot InnateTM potato is unlikely to substantially affect 

non-target organisms, such as mammals, birds, or insects. Simplot data demonstrates that the 

composition of Simplot IlmateTM potato does not substantially differ from conventional potato 

varieties (Simplot, 2013a). Simplot indicated that they have submitted a safety and nutritional 

assessment of food and feed derived from Simp lot IlmateTM potato to ilie FDA on February 12, 

2013 (Simplot, 20!3a). FDA is presently evaluating the submission. There is no evidence ilia! 

animal exposure to Simplot InnateTM potato would have any effect or be any less attractive as 

food, refuge, cover and nesting sites as non GE varieties of potatoes. 

APHIS evaluated in the EA, Simplot's data on agronomic perfonnance, disease and insect 

susceptibility, and compositional profiles oflm1ateTM potato. APHIS analysis indicates no significant differences between Innate TM potato and non-transgenic counterparts that would be 

expected to cause either a direct or indirect adverse effect on non-target organisms. Field trials 

conducted over a 3-year period with InnateTM potato have not shown any observable significant 

differences between InnateTM potato and non-transgenic controls. Because of this, there is no 

scientific reason to expect that ilie transformed IlmateTM potato would have a negative impact on 

non-target organisms. Insect population diversity represents one measure of general impacts, and 

there were no differences observed at vmious times during development of the crop. In the 

absence of any observable acute stresses or impacts, there is no reason to presume that long tenn 

impacts would be expected, nor that a need exists to monitor for them. APHIS has carefully 

considered the possible enviromnental impacts of tl1e proposed action, and is satisfied that the 

EA prepared by APHIS is adequate and sufficient. 

As discussed in Section 2.3 .3 of the EA, Gene Flow and Weediness, because potato is primmily 

clonally propagated, exposure of pollinators to pollen is limited. Furthennore, the site of gene 

silencing is primarily limited to the tuber and stolons, not the leaves and stems, thereby leading 

to restricted access of the gene silencing to insects and other nontarget organisms. Muttucumaru 

eta!. (Muttucwnaru et al., 2014) notes that "the strategy of targeting asparagine synthesis 

specifically in the tuber makes sense because asparagine has been shown not to be a major 

transported amino acid in potato, so the free asparagine tl1at accumulates in tubers must be 

synthesized there." 
demonstrated that there were no differences between infestation of insects in the InnateTM 

potatoes compared to their untransfonned controls. 

The EA has reported on the safety oflnnate TM potato in the environmental consequences and 

cumulative impacts sections under various headings, including those on animals, plants, 

biodiversity, microbes and human health. Based upon infonnation and analysis presented in the 

petition, PPRA, and EA, APHIS has not identified any potential for hann to the environment 

from Innate TM potato 

Issue 17: APHIS did not ''properly" consider its obligations to migrato1y birds. A comment 

from an NGO stated that APHIS failed to properly consider and disclose its obligations to 

migratory birds. Specifically, Executive Order 13186 requires federal agencies to develop and 

implement a Memorandum of Understanding (MOU) with the FWS to promote the conservation 

of migratory bird populations. Further, that APHIS did not adequately assess impacts to 

migratory birds, and that APHIS did not consider the pennitting requirements that allow the 

"take" of a migratory bird under certain activities, none of which include the types of activities 

discussed in the EA, and therefore no take of even a single migratory bird is allowed. 

APHIS Response: 

APHIS disagrees with the commenter. First, as required by Executive Order 13186, APHIS has 

in place a signed MOU with the FWS (APHIS-USFWS, 2012). Second, APHIS has considered 

its obligations under the Migratory Bird Treaty Act and aclmowledged in the EA that migratory 

birds, particularly waterfowl, may forage in agricultural fields including potato fields. However, 

APHIS came to the conclusion that granting nonregulated status to InnateTM potato would have 

no impact on any migratory birds because InnateTM potato is similar to other potato varieties, 

with the exception the silencing of four different genes in potato: asparagine synthetase-] (Asnl), 

polyphenol oxidase-5 (Ppo5), potato phosphorylase L (PizL) and the starch-associated Rl gene 

(RJ). The suppression of Asnl results in potatoes with reduced free asparagine, and the 

suppression of PhL and Rl results in potatoes with a lower content of reducing sugars. 

Collectively, the silencing of these 3 genes should result in potato tubers with a reduced 

acrylamide potential. The suppression of Ppo5 confers the !!mateTM potato with a non-browning 

phenotype resulting in tubers with reduced black spot bruising (Simplot, 2013b), (USDAAPHIS, 2013b). AHIS has determined that there is no reason to believe that reduced free 

asparagine or reduced black spot bruising would have any effect on migratory birds. The 

applicant provided data to demonstrate the compositional equivalency oflnnateTM potato and 
bird is expected as a result of growing InnateTM potato, and APHIS could not detennine any mechanism by which take would occur, or would occur any differently than production of any 

otl1er potato variety. 

Issue 18: APHIS did not "adequately" assess impacts on threatened and endangered species. 

One commenter from an NGO stated that InnateTM potato may significantly affect threatened and 

endangered species (TES) and expressed concern that APHIS had "failed to consult" with the 

United States Fish and Wildlife Service (USFWS) or the National Marine Fisheries Service 

(NMFS) on the potential effects to threatened and endangered species and their critical habitats, 

as required under section 7 of the Endangered Species Act (ESA), and that "APHIS must prove" 

its deregulation oflnnateTM Potato will neither jeopardize any species nor hann any critical 

habitat anywhere the crop may be grown. Furtl1er, that APHIS failed to obtain information from 

USFWS/NMFS on species that may be present in the area where InnateTM potato would be 

grown. 

APHIS Response: 

APHIS disagrees with this comment. As required under Section 7 of the ESA, APHIS 

considered the potential for effects from the proposed determination of nonregulated status for 

InnateTM potato on federally listed threatened and endangered species and species proposed for 

listing, as well as effects on designated critical habitat and habitat proposed for designation. 

APHIS considered possible effects on all listed species as well as all species proposed for listing 

as well as all designated critical habitat and habitat proposed for designation in States where 

potatoes are commercially grown. Species infom1ation was obtained from the USFWS 

Environmental Conservation Online System (ECOS; as accessed February 19,2014 at 

http:// ecos.fws. gov/tess public/pub/stateListingAndOccurrence. j sp) (USDA -APHIS, 20 14a ), 

(USDA-APHIS, 2014b). After analyzing the potential for any effect, APHIS concluded that tl1e 

detennination of nonregulated status for InnateTM potato will have no effect on any federally 

listed threatened and endangered species or species proposed for listing, as well no effect on any 

designated critical habitat or habitat proposed for designation. Because of this no effect 

detennination, consultation with, or tl1e concurrence of, the USFWS and/or NMFS is not 

required. 
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