NATIONAL ENVIRONMENTAL POLICY ACT DECISION

AND

PRELIMINARY FINDING OF NO SIGNIFICANT IMPACT

Pioneer Hi-Bred International, Inc.

Event 73496 Canola

United States Department of Agriculture

Animal and Plant Health Inspection Service

Biotechnology Regulatory Services

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

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

National Environmental Policy Act (NEPA) of 1969, 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 the APHIS NEPA decision and its rationale. Comments from the public 

involvement process were evaluated and considered in developing this NEPA decision.

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

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

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

status of genetically engineered (GE) event DP-073496 Canola (hereafter referred to as 73496 

Canola), the subject of a petition request (APHIS Number 11-063-01p) by Pioneer Hi-Bred 

International, Inc. (Pioneer) The 73496 Canola is resistant to the herbicide, glyphosate. The EA

has been prepared to specifically evaluate the effects on the quality of the human environment 

that may result from approving the petition seeking nonregulated status for 73496 Canola. The 

EA assesses alternatives to a determination of nonregulated status of 73496 Canola and analyzes 

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

alternatives.

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 public health. 

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

GE varieties) can increase farm income, and provide benefits to the environment and consumers.

Since 1986, the United States government has regulated GE organisms pursuant to a regulatory 

framework known as the Coordinated Framework for the Regulation of Biotechnology 

(Coordinated Framework) (51 FR 23302, 57 FR 22984). The Coordinated Framework, 

published by the Office of Science and Technology Policy, describes the comprehensive federal 

regulatory policy for ensuring the safety of biotechnology research and products and explains 
how federal agencies will use existing Federal statutes in a manner to ensure public health and 

environmental safety while maintaining regulatory flexibility to avoid impeding the growth of 

the biotechnology industry. The Coordinated Framework is based on several important guiding 

principles: (1) agencies should define those transgenic organisms subject to review to the extent 

permitted by their respective statutory authorities; (2) agencies are required to focus on the 

characteristics and risks of the biotechnology product, not the process by which it 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 APHIS, the Food and Drug 

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

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

the Plant Protection Act of 2000 (PPA), as amended (7 USC §§ 7701 et seq.) to ensure that they 

do not pose a plant pest risk to the environment.

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

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

concerning regulation of products derived from new plant varieties, including those GE, was 

published in the Federal Register on May 29, 1992 (57 FR 22984-23005). Under this policy, 

FDA uses what is termed a consultation process to ensure that human food and animal feed 

safety issues or other regulatory issues (e.g., labeling) are resolved prior to commercial 

distribution of bioengineered foods.

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

Rodenticide Act (FIFRA). Under FIFRA, EPA is responsible for regulating the sale, 

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

techniques of modern biotechnology. EPA also sets tolerance limits for residues of pesticides 

on and in food and animal feed, or establishes an exemption from the requirement for a 

tolerance, under the Federal Food, Drug and Cosmetic Act (FFDCA), and regulates certain 

biological control organisms under the Toxic Substances Control Act (TSCA). The EPA is 

responsible for regulating the sale, distribution, and use of pesticides, including pesticides that 

are produced by an organism through techniques of modern biotechnology.

Regulated Organisms

The APHIS Biotechnology Regulatory Services’ (BRS) mission is to protect America’s 

agriculture and environment using a dynamic and science-based regulatory framework that 

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 PPA, as amended (7 United States Code (U.S.C.) 7701-7772), to regulate the introduction 

(importation, interstate movement, or release into the environment) of certain GE organisms and 

products. A GE organism is no longer subject to the plant pest provisions of the PPA or to the 

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

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

organism, vector, or vector agent used in engineering the organism is 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 information to determine if the GE organism is unlikely to pose a 

plant pest risk.

A person may petition the agency for a determination that a particular regulated article is 

unlikely to pose a plant pest risk, and, therefore, is no longer regulated under the plant pest risk 

provisions of the PPA or the regulations at 7 CFR part 340. The petitioner is required to provide 

information 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 PPA 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 PPA 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 73496 Canola. When a petition for 

nonregulated status is submitted, APHIS must make a determination if the GE organism is 

unlikely to pose a plant pest risk. If APHIS determines, based on its Plant Pest Risk 

Assessment (PPRA), that the GE organism is unlikely to pose a plant pest risk, it is no longer

subject to the plant pest provisions of the PPA and 7 CFR part 340.

Pioneer has submitted a petition (APHIS Number 11-063-01p) to APHIS seeking a 

determination that their GE 73496 Canola is unlikely to pose a plant pest risk and, therefore, 

should no longer be a regulated article under regulations at 7 CFR part 340. 

73496 Canola

73496 Canola has been genetically engineered to express the GAT4621 (glyphosate 

acetyltransferase) protein to convey resistance to the herbicide glyphosate. Pioneer 73496 

Canola provides growers with an alternative to glyphosate-resistant canola products marketed 

currently. Herbicide-Resistant 73496 Canola will provide similar benefits to currently available 

glyphosate-resistant canola varieties by allowing post emergent applications of glyphosate to 

control weeds. 
Coordinated Framework Review

Food and Drug Administration

73496 Canola is within the scope of the FDA policy statement concerning regulation of products 

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

indicated that a New Protein Consultation for the GAT4621 protein was submitted to FDA on 

January 31, 2007 and completed on October 7, 2009. Pioneer submitted a safety and nutritional 

assessment of food and feed derived from 73496 Canola to the FDA in February 2011. Based on 

the information Pioneer submitted, and as of May 1, 2012, FDA has no further questions 

regarding 73496 Canola (US-FDA, 2012)

Environmental Protection Agency

The EPA has authority over the use of pesticide substances and plant-incorporated protectants 

(PIPs) under the FIFRA as amended (7 USC §136, et seq.) and the FFDCA (21 USC §301, et 

seq.). APHIS considers the EPA’s regulatory assessment when assessing potential impacts 

that may result from a determination of nonregulated status of a GE organism. 

EPA has authority under FIFRA to establish pesticide use restrictions. These are listed on 

pesticide labels which are prepared during the pesticide registration process. 73496 Canola is 

similar to currently available glyphosate-resistant canola varieties. Pioneer indicates that there 

will be no change in the use pattern for glyphosate on this glyphosate-resistant variety. APHIS

used the current glyphosate labels as the basis for its evaluation of the potential impacts 

associated with the use of and exposure to glyphosate. 

Scope of the Environmental Analysis

Although a determination of nonregulated status of 73496 Canola would allow for new plantings 

of 73496 Canola anywhere in the U.S., APHIS primarily focused the environmental analysis on

those geographic areas that currently support canola production. A determination of 

nonregulated status of 73496 Canola is not expected to increase canola production by its 

availability alone or when accompanied by other factors, nor should it cause an increase in 

overall GE-canola acreage. To delineate areas in the U.S. where canola is produced, APHIS 

used data from the National Agricultural Statistics Service (NASS) (UDA-NASS, 2012). In

North America, the primary canola-growing region is in areas of the Great Plains 

characterized by high quality soil, but shorter, drier growing seasons than that preferred by 

most corn and soybean varieties. Most of this region is in the prairie provinces of Canada, but

part of it extends into North Dakota. From 2003-2012, the average canola production in the U.S. 

has been about 1.1 million acres (USDA-NASS, 2012). According to the 2007 Census of 

Agriculture North Dakota produced about 93% of all the canola grown in the U.S.

Public Involvement
On July 13, 2012, APHIS published a notice in the Federal Register (77 FR pages 41364-41366, 

Docket no. APHIS-2012-0031) announcing the availability of the Pioneer petition for a 60-day 

public review and comment period. Comments were required to be received on or before 

September 11, 2012. All comments were carefully analyzed to identify potential environmental 

and interrelated economic issues and impacts that APHIS may determine should be considered in 

the evaluation of the petition. A total of 4,686 comments were received during the comment 

period1

. The issues that were raised in the public comments which were related to the Pioneer 

73496 Canola petition included:

• Canola outcrossing with other mustards

• Canola forming feral populations

• Development of herbicide resistant weeds

• Use of herbicides on herbicide resistant crops

• The fate of glyphosate in air and water

• The effects of glyphosate use on biological organisms

• The effect of glyphosate drift on outcrossing to weedy or wild relatives

• Increase in plant pathogens or susceptibility to plant pathogens from the use of 

glyphosate

• Concern that cross-pollination between GE and organic or crops for GE-sensitive markets 

will affect sales for growers of these crops.

• Concerns that Pioneer 73496 Canola is not approved in all export markets.

APHIS evaluated these raised issues and the submitted documentation. APHIS has included a 

discussion of these issues in this EA

Major Issues Addressed in the EA

 Issues discussed in the EA were identified by considering public concerns and issues described 

in public comments for the petition for nonregulated status of 73496 Canola and other 

environmental assessments of GE organisms. Issues identified in lawsuits, and those submitted 

by various stakeholders were also discussed. These issues, including those regarding the 

agricultural production of canola using various production methods, and the environmental 

food/feed safety of GE plants, were addressed to analyze the potential environmental impacts of 

73496 Canola.

The EA describes the alternatives considered and evaluated using the issues identified. These

include the following that were identified as important to the scope of the analysis (40 CFR 

1508.25):

Agricultural Production Considerations:

1 Comment documents may be viewed at 

http://www.regulations.gov/#!docketBrowser;rpp=25;po=0;dct=PS;D=APHIS-2012-0031.

 
• Acreage and Areas of Canola Production

• Agronomic/Cropping Practices

• Canola Seed Production

• Organic Canola Production

Environmental Considerations:

• Water Resources

• Soil

• Air Quality

• Climate Change

• Animals

• Plants

• Microorganisms

• Biological Diversity

Human Health Considerations:

• Consumer Health

• Worker Safety

Livestock Health Considerations:

• Livestock Health/Animal Feed

Socioeconomic Considerations:

• Domestic Economic Environment

• Trade Economic Environment

Alternatives that were fully analyzed

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

status of 73496 Canola. To respond favorably to a petition for nonregulated status, APHIS must 

determine that 73496 Canola is unlikely to pose a plant pest risk. Based on its Plant Pest Risk 

Assessment (USDA-APHIS, 2013), APHIS has concluded that 73496 Canola is unlikely to pose 

a plant pest risk. Therefore, APHIS must determine that 73496 Canola is no longer subject to 7 

CFR part 340 or the plant pest provisions of the PPA. Two alternatives were evaluated in the 

EA: (1) no action and (2) determination of nonregulated status of 73496 Canola. 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. 73496 Canola and progeny 

derived from 73496 Canola would continue to be regulated articles under the regulations at 7 

CFR part 340. Permits issued or notifications acknowledged by APHIS would still be required 

for introductions of 73496 Canola and measures to ensure physical and reproductive confinement 

would continue to be implemented. APHIS would choose this alternative if there were 

insufficient evidence to demonstrate the lack of plant pest risk from the unconfined cultivation of 

73496 Canola. 

This alternative is not the preferred alternative because APHIS has concluded through a Plant 

Pest Risk Assessment that 73496 Canola is unlikely to pose a plant pest risk (USDA-APHIS, 

2013). Choosing this alternative would not satisfy the purpose and need of making a 

determination of plant pest risk status and responding to the petition for nonregulated status.

Preferred Alternative: Determination that 73496 Canola is No Longer a Regulated Article

Under this alternative, 73496 Canola and progeny derived from 73496 Canola would no longer 

be regulated articles under the regulations at 7 CFR part 340. 73496 Canola is unlikely to pose a 

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

would no longer be required for introductions of 73496 Canola and progeny derived from this 

event. The preferred 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 PPA. Because the agency has concluded that 

73496 Canola is unlikely to pose a plant pest risk, a determination of nonregulated status of 

73496 Canola is a response that is consistent with the plant pest provisions of the PPA, the 

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

Coordinated Framework.

Alternatives Considered but Rejected from Further Consideration

APHIS assembled a list of alternatives that might be considered for 73496 Canola. The agency 

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

the PPA, 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 73496 Canola. 

Based on this evaluation, APHIS rejected several alternatives. These alternatives are discussed 

briefly below along with the specific reasons for rejecting each.

1. Prohibit any 73496 Canola from Being Released

In response to public comments that stated a preference that no GE organisms enter the 

marketplace, APHIS considered prohibiting the release of 73496 Canola, including denying any 

permits associated with the field testing. APHIS determined that this alternative is not 

appropriate given that APHIS has concluded that 73496 Canola is unlikely to pose a plant pest

risk (USDA-APHIS, 2013). 
In enacting the PPA, Congress listed findings in Section 402(4), including the following one:

“[D]ecisions affecting imports, exports, and interstate movement of products regulated 

under this title [the Plant Protection Act] shall be based on sound science;”

On March 11, 2011, in a Memorandum for the Heads of Executive Departments and Agencies, 

the White House Emerging Technologies Interagency Policy Coordination Committee developed 

broad principles, consistent with Executive Order 13563, to guide agencies that develop and 

implement policies for oversight of emerging technologies such as genetic engineering. In 

accordance with this memorandum, agencies should adhere to guidance in Executive Order 

13563, and, consistent with it, apply the following principle, among others to the extent 

permitted by law when regulating emerging technologies:

“Decisions should be based on the best reasonably obtainable scientific, technical, 

economic, and other information, within the boundaries of the authorities and mandate of 

each agency;”

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

concluded that 73496 Canola is unlikely to pose a plant pest risk. Accordingly, there is no basis 

in science for prohibiting the release of 73496 Canola.

2. 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 of nonregulated status in part may be appropriate if there 

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

has concluded that 73496 Canola is unlikely to pose a plant pest risk, (USDA-APHIS, 2013), 

there is no regulatory basis under the plant pest provisions of the PPA for considering approval 

of the petition only in part.

3. Isolation Distance between 73496 Canola and Non-GE Canola Production and 

Geographical Restrictions

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

considered requiring an isolation distance separating 73496 Canola from conventional or 

specialty canola production. However, because APHIS has concluded that 73496 Canola is 

unlikely to pose a plant pest risk (USDA-APHIS, 2013), an alternative based on requiring 

isolation distances would be inconsistent with statutory authority under the plant pest provisions 

of the PPA and regulations in 7 CFR part 340.

APHIS also considered geographically restricting the production of 73496 Canola based on the 

location of production of non-GE canola in organic production systems or production systems 

for GE-sensitive markets in response to public concerns regarding possible gene movement 

between GE and non-GE plants. However, as presented in APHIS’ PPRA for 73496 Canola, 
there are no geographic differences associated with any identifiable plant pest risks for 73496 

Canola (USDA-APHIS, 2013). This alternative was rejected and not analyzed in detail because 

APHIS has concluded that 73496 Canola does not present a plant pest risk, and will not exhibit a 

greater plant risk in any geographically restricted area. Therefore, such an alternative would not 

be consistent with APHIS’ statutory authority under the plant pest provisions of the PPA and 

regulations in Part 340 and the biotechnology regulatory policies embodied in the Coordinated 

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 PPA. However, individuals might choose on their own to geographically 

isolate their non-GE production systems from 73496 Canola or to use isolation distances and 

other management practices to minimize gene movement between canola fields. Information to 

assist growers in making informed management decisions for 73496 Canola is available from the 

Association of Official Seed Certifying Agencies (AOSCA, 2011).

4. Requirement of Testing for 73496 Canola

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

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

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

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

implement and maintain. Additionally, because 73496 Canola does not pose a plant pest risk 

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

the plant pest provisions of the PPA, the regulations at 7 CFR part 340 and biotechnology 

regulatory policies embodied in the Coordinated Framework. Therefore, imposing such a 

requirement for 73496 Canola 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 alternatives 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
.

Summary of Issues of Potential Impacts and Consequences of Alternatives.

 Attribute/Measure Alternative A:No Action

Alternative B:Determination of 

Non-

 Meets Purpose, Need and 

Objectives

No Yes

Unlikely to Pose a Plant Pest Risk Satisfied by regulated field trials. Satisfied – risk assessment

(USDA-APHIS, 2013)

Management Practices

Acreage and Areas of Canola

Production

Since the 1999 introduction of 

herbicide-resistant canola in the 

U.S., production has fluctuated

between 0.8-1.6M acres. Average

U.S. canola acreage is about 1.1M 

acres. In 2007 about 93% of it was 

located in North Dakota. In 

2006,nearly all (99%) of the ND

crop was herbicide resistant; 57% 

of that was glyphosate resistant.

No change from Alternative A

Agronomic Practices

Conservation tillage, which tends 

to provide a competitive 

advantage to canola production 

by promoting earlier crop 

emergence, has increased since 

the introduction of HR canola 

varieties. In the northern U.S., use 

of tillage has declined from 89% to 

35%; in some individual instances 

it remains useful in managing 

herbicide-resistant weeds. About

half of growers rely on a 3-year 

rotation of canola, a small grain, 

and soybean. The remaining 

growers use a two-year rotation of 

canola and wheat. 

No change from Alternative A
Summary of Issues of Potential Impacts and Consequences of Alternatives.

 Attribute/Measure Alternative A:No Action

Alternative B:Determination of 

Non-

 

Canola Seed Production Most seed production is in

Alberta In the U.S seed 

production occurs in the

Columbia Basin in eastern f, the

Grand Ronde Valley in Union

County in northeastern Oregon,

and the San Luis Valley in south

central Colorado. Most seed

companies have off-season seed

production locations in the

southwestern U.S. About 5,000

acres of commercial seed 

production supply enough seed

to plant the entire U.S. canola

crop.

No change from Alternative A

Pesticide Use EPA-approved uses of herbicides

on canola. Herbicides are 

specifically labeled to allow their 

use on HR canola. 

No change from Alternative A

Organic Canola Production

Certified organic production is an 

extremely small component of canola 

production conducted primarily in 

regions remote from major GE 

canola crop sites.

No change from No Action 

Alternative

Environment

Soil Quality

Herbicide applications in 

conjunction with HR canola have 

promoted conservation tillage, 

which preserves soil quality by 

reducing erosion. Growers 

currently use best management 

practices to address their specific

needs in producing canola.

No change from No Action 

Alternative

Water Resources

The most significant source of nonpoint source pollution is increased 

sedimentation from soil erosion, 

which can introduce sediments, 

fertilizers, and pesticides to 

No change from No Action 

Alternative
Summary of Issues of Potential Impacts and Consequences of Alternatives.

 Attribute/Measure Alternative A:No Action

Alternative B:Determination of 

Non-

 

nearby lakes and streams. 

Glyphosate has a high affinity for 

binding with most types of soils, 

where it is degraded. This limits 

its mobility and transport into 

surface and groundwater.

Air Quality

Agricultural activities such as 

tilling, harvesting, spraying 

pesticides, and fertilizing, 

including the emissions from farm 

equipment, can directly affect air 

quality. Applications may impact 

air quality from: drift; diffusion; 

volatilization of chemicals; 

exhaust emissions from motor 

vehicles and aircraft.

No change from No Action 

Alternative

Climate Change

Agriculture-related activities are

direct sources of greenhouse

gases(e.g., exhaust from 

motorized equipment) and 

indirect sources

(e.g., soil disturbance from 

tillage, fertilizer production)

No change from No Action 

Alternative

Animal Communities

Invertebrates that feed on canola 

are typically considered pests and 

may be controlled by the use of 

insecticides or other production 

practices. Seed treatments are 

recommended to prevent flea 

beetle damage of young plants 

and foliar insecticide applications 

are recommended if damage 

reaches an economic threshold.

No change from No Action 

Alternative

Plant Communities

Plants growing in canola fields are 

considered weeds. Weeds can

complete with growing canola 

No change from No Action 

Alternative
Summary of Issues of Potential Impacts and Consequences of Alternatives.

 Attribute/Measure Alternative A:No Action

Alternative B:Determination of 

Non-

 

plants for resources such as water, 

light, and soil nutrients. Young 

canola seedlings are very sensitive 

to early weed competition. 

Growers control weeds in and 

around fields using cultural, 

mechanical and chemical 

methods.

Canola can form feral populations.

Canola can hybridize with certain 

sexually compatible mustard 

plants.

Soil Microorganisms

APHIS has previously examined

potential impacts of glyphosate on

microorganisms in soils of field 

under cultivation with HR crops, 

and has not found evidence 

linking applications of glyphosate 

to changes in soil microbial 

communities that have adverse 

effects on plants grown in those 

soils.

No change from No Action 

Alternative
Summary of Issues of Potential Impacts and Consequences of Alternatives.

 Attribute/Measure Alternative A:No Action

Alternative B:Determination of 

Non-

 

Biological Diversity

HR crops, such as canola, have 

been correlated with an increase 

in conservation tillage in U.S. crop 

production, which promotes 

biodiversity by allowing the 

establishment of other plants, and 

the accumulation of more plant 

residue that increases soil organic 

matter, food, and cover for 

wildlife. Effects of GE crops have 

been associated with positive

impacts on biodiversity because of

increased yields, fewer 

applications of less toxic 

pesticides, and facilitation of 

conservation tillage.

No change from No Action 

Alternative

Land Use

Canola is minor crop produced on 

approximately 0.04% of the 

harvested cropland in the U.S. 

Currenttrendsinfluencing the 

acreage of canola planted annually are

driven bymarket conditions (e.g., 

increased demand for US canola 

products and animal feed)) and

federal policy

No change from No Action 

Alternative

Human and Animal Health

Risk to Human Health

Canola oil has one component 

(erucic acid) of human health 

significance because of its toxic 

properties. Varieties that produce 

oil with less than 2% of this fatty 

acid are defined as canola, and are 

generally regarded as safe by FDA. 

Residues, such as that that might 

arise from the GAT protein are 

removed during filtration. 

Workers that routinely handle

glyphosate, may be exposed 

No change from No Action 

Alternative
Summary of Issues of Potential Impacts and Consequences of Alternatives.

 Attribute/Measure Alternative A:No Action

Alternative B:Determination of 

Non-

 

during spray operations. Because 

of low acute toxicity of 

glyphosate, absence of evidence 

of carcinogenicity and other 

toxicological concerns, 

occupational exposure data is not 

required for reregistration. 

However, EPA has classified some 

glyphosate formulations as eye 

and skin irritants. When used 

consistent with the label, 

pesticides present minimal risk to 

human health and safety.

Risk to Animal Feed

Most canola cultivated in the 

U.S. is used to produce vegetable 

oil and animal feed. Canolabased animal feed is currently 

produced from GE canola 

varieties that are no longer 

subject to the regulatory 

requirements of 7 CFR part 340 

or the plant pest provisions of the 

PPA. This includes HR GE 

canola varieties.

No change from No Action 

Alternative

Socioeconomic 

Domestic Economic Environment

Farm income is positively impacted

by currently available HR canola 

by reducing production costs or 

increasing revenues. GR canola

generally has a positive impact on

farm income due to costsavings 

from reduced fuel and pesticide

use.

No change from No Action 

Alternative

Trade Economic Environment

Because the U.S. crushes more 

canola seed than it produces, the 

U.S. imports canola seed to meet 

the demand of the oil market. 

The U.S. exported 150-300 

thousand metric tons of canola 

No change from No Action 

Alternative
Summary of Issues of Potential Impacts and Consequences of Alternatives.

 Attribute/Measure Alternative A:No Action

Alternative B:Determination of 

Non-

 

each year between 2007 and 

2011. The majority of the canola 

exported went to Canada where 

it was processed. Foreign sales 

are mostly to Canadian crushing 

plants. The U.S. share of world 

production remains small, but is 

an increasingly important 

component of regional

economies in the Northern 

Plains.

Other Regulatory Approvals

U.S. FDA completed consultations.

No change from No Action 

Alternative.

Satisfied: consultations with 

other agencies participating in 

the Coordinated Regulatory 

Framework completed.

Compliance with Other Laws

CWA, CAA, EOs

Fully compliant

No change from No Action 

Alternative:

Finding of No Significant Impact

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 NEPA 

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

Context - The term “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 canola production systems, including surrounding environments and 

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

commodity markets. 
From 2003-2012, the average canola production in the U.S. has been about 1.1 million acres 

(USDA-NASS, 2012). According to the 2007 Census of agriculture North Dakota produced 

about 93% of all the canola grown in the U.S. In 2008, GE (glyphosate and glufosinate) 

herbicide-resistant canola was estimated to be 95% of the U.S. canola crop (Brookes and 

Barfoot, 2010). In 2006, 99% of the production in the principal U.S. canola-growing state of 

North Dakota was derived from herbicide-resistant canola varieties, with glyphosate-resistant

varieties grown on 57% of that acreage (Johnson et al., 2007). A determination of nonregulated

status of 73496 Canola is not expected to directly cause an increase in agricultural acreage 

devoted to canola production, or those canola acres devoted to GE canola cultivation. The 

availability of 73496 Canola will not change cultivation areas for canola production in the U.S.,

and there are no anticipated changes to the availability of GE and non-GE canola 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. 

A determination of nonregulated status of 73496 Canola will have no significant 

environmental impact on the availability of GE, conventional, or organic canola varieties. 

As discussed in Chapter 4 of the EA, a determination of nonregulated status of 73496 

Canola is expected to neither directly cause an increase in overall canola production 

acreage, nor GE-canola acreage. The availability of 73496 Canola will not change the 

cultivation areas for canola production in the U.S., and there are no anticipated changes 

in the availability of GE and non-GE canola varieties on the market. A determination of 

nonregulated status of 73496 Canola could add another GE canola variety to the 

conventional canola market, but is not expected to change the market demands for GE 

canola or canola produced using organic methods. The 2008 Census of Agriculture 

indicated that there were approximately 232 acres of organic canola grown in four states, 

with a value of about 0.03% of the total value of the canola crop in the same year 

(USDA-NASS, 2008). Based on the data provided by Pioneer for 73496 Canola

(Pioneer, 2011), APHIS has concluded that the availability of 73496 Canola would not 

alter the agronomic practices, locations, and seed production and quality characteristics 

of conventional and GE canola seed production (USDA-APHIS, 2013). A determination 

of nonregulated status of 73496 Canola will not require a change to seed production 

practices, nor current production practices. The introduction of 73496 Canola provides 

an alternative canola variety with glyphosate tolerance.

2. The degree to which the proposed action affects public health or safety. 

A determination of nonregulated status of 73496 Canola would have no significant 

impacts on human or animal health. Compositional tests conducted by the petitioner 

indicate that 73496 Canola is compositionally similar to other commercially available GE 

canola (Pioneer, 2011). Pioneer initiated the consultation process with FDA for the 
commercial distribution of 73496 Canola and submitted a safety and nutritional 

assessment of food and feed derived from 73496 Canola to the FDA in February 2011. 

Based on the information Pioneer submitted, and as of May 1, 2012, FDA has no further 

questions regarding 73496 Canola (US-FDA, 2012). Based on the FDA’s consultation, 

laboratory data and scientific literature provided by Pioneer (Pioneer, 2011), and safety 

data available on other herbicide-resistant products, APHIS has concluded that 73496 

Canola would have no significant impacts on human or animal health.

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

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

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 be 

adversely impacted by a determination of nonregulated status for 73496 Canola. The 

common agricultural practices that would be carried out under the proposed action will 

not cause major ground disturbance, nor cause any physical destruction or damage to 

property, wildlife habitat, or landscapes, and do not involve the sale, lease, or transfer of 

ownership of any property. This action is limited to a determination of nonregulated

status of 73496 Canola. The product will be deployed on agricultural land currently 

suitable for production of canola, will replace existing varieties, and is not expected to 

increase the acreage of canola production. This action would not convert land to 

nonagricultural use and therefore would have no adverse impact on prime farm land. 

Standard agricultural practices for land preparation, planting, irrigation, and harvesting of 

plants would be used on agricultural lands planted to 73496 Canola 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 73496 Canola, the action is not likely to affect 

historic or cultural resources, park lands, prime farmlands, wetlands, wild and scenic 

rivers, or ecologically critical areas that may be in close proximity to canola production 

sites.

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

highly controversial.

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

nonregulated status for 73496 Canola are not highly controversial. Although APHIS 

received public comments opposed to a determination of nonregulated status of 73496 

Canola, this action is not highly controversial in terms of size, nature or effect on the 

natural or physical environment. As discussed in Chapter 4 of the EA, a determination of 

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

devoted to canola production, or those acres devoted to glyphosate resistant canola

cultivation. The availability of 73496 Canola will not change cultivation areas for canola

production in the U.S., and there are no anticipated changes to the availability of non-GE-
and GE-canola varieties on the market. A determination of nonregulated status of 73496 

Canola would add another GE-canola variety to the conventional canola market and is 

not expected to change the market demands for GE canola or canola produced using 

organic methods. A determination of nonregulated status of 73496 Canola will not 

change current practices for planting, tillage, fertilizer application/use, cultivation, 

pesticide application/ use, or volunteer control. Management practices and seed 

standards for production of certified canola seed would not change. The effect of 73496 

Canola on wildlife or biodiversity is no different than that of other glyphosate resistant

canola currently used in agriculture, or other GE or non-GE canola produced in 

conventional agriculture in the U.S. 

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

or involve unique or unknown risks.

Based on the analysis documented in the EA, the possible effects on the human 

environment are well understood. The effects of the proposed activities are not highly 

uncertain and do not involve unique or unknown risks on the natural or physical 

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

status of 73496 Canola is expected to neither directly cause an increase in agricultural 

acreage devoted to canola production, nor increase those acres devoted to GE-canola

cultivation. A determination of nonregulated status of 73496 Canola will not result in 

changes in the current practices of planting, tillage, fertilizer application/use, pesticide 

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

production of certified canola seed would not change. The effect of 73496 Canola on 

wildlife or biodiversity is neither different than that from other herbicide-resistant crops 

currently used in agriculture, nor that of other GE or non-GE canola produced in 

conventional agriculture in the U.S. As described in Chapter 2 of the EA, wellestablished management practices, production controls, and production practices (GE, 

conventional, and organic) are currently being used in canola production systems 

(commercial and seed production) in the U.S. Therefore, it is reasonable to assume that 

farmers, who produce conventional canola (GE and non-GE varieties), 73496 Canola, or 

produce canola using organic methods, will continue to use these reasonable, commonlyaccepted, best-management practices for their chosen systems and varieties during 

agricultural canola production. GE canola is also planted currently on the majority of 

canola acres (95% of acreage in 2008) (Brookes and Barfoot, 2010). Based upon historic 

trends, conventional production practices that use GE varieties will likely continue to 

prevail in terms of acreage with or without a determination of nonregulated status of 

73496 Canola. Given the extensive experience that APHIS, stakeholders, and growers 

have with the use of GE canola products, the possible effects to the human environment 

from the release of an additional GE-canola product are already well known and 

understood. Therefore, the impacts are not highly uncertain, and do not involve unique 

or unknown risks.
6. The degree to which the action may establish a precedent for future actions with 

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

A determination of nonregulated status for 73496 Canola would not establish a precedent 

for future actions with significant effects, nor would it represent a decision in principle 

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

APHIS, a determination 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 determine if the regulated article poses a plant pest 

risk. Under the authority of the plant pest provisions of the PPA 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 

73496 Canola. When a petition for nonregulated status is submitted, APHIS must 

determine if the GE organism is unlikely to pose a plant pest risk. If APHIS determines,

based on its Plant Pest Risk Assessment, that the GE organism is unlikely to pose a plant 

pest risk, the GE organism is no longer subject to the plant pest provisions of the PPA 

and 7 CFR part 340. APHIS regulations at 7 CFR part 340, which were promulgated 

pursuant to authority granted by the PPA, as amended (7 United States Code(U.S.C.) 

7701-7772), regulate the introduction (i.e., importation, interstate movement, or release 

into the environment) of certain GE organisms and products. A GE organism is no 

longer subject to the plant pest provisions of the PPA nor 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 classified as a plant pest. A GE organism is 

also regulated under Part 340 when APHIS has reason to believe that the GE organism 

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

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

decision that a particular regulated article is unlikely to pose a plant pest risk, and, 

therefore, is no longer regulated under the plant pest provisions of the PPA or the 

regulations at 7 CFR part 340. The petitioner is required to provide information 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 provisions of the PPA when APHIS determines that it is 

unlikely to pose a plant pest risk.

7. Whether the action is related to other actions with individually insignificant but 

cumulatively significant impacts.
No significant cumulative effects were identified during this assessment. The EA 

discussed cumulative effects on canola management practices, human and animal health, 

and the environment, and concluded that such impacts were not significant. A 

cumulative effects analysis is provided in Chapter 5 of the EA. In the event APHIS 

reaches a determination of nonregulated status of 73496 Canola, APHIS would no longer 

have regulatory authority over this canola. In the event of a determination of 

nonregulated status of 73496 Canola, APHIS has not identified any significant impact on 

the environment that may result from the incremental impact of a determination of 

nonregulated status of 73496 Canola 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 determination of nonregulated status of 73496 Canola will not adversely impact 

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

farmers 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 

determination of nonregulated status of 73496 Canola would not impact 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 of significant 

scientific, cultural, or historic resources. This action is limited to a determination of 

nonregulated status of 73496 Canola. Standard agricultural practices for land 

preparation, planting, irrigation, and harvesting of plants would be used on these 

agricultural lands including the use of EPA-registered pesticides. Adherence to EPAlabel-use restrictions for all pesticides will mitigate impacts to the human environment. 

A determination of nonregulated status of 73496 Canola is a decision that will not 

directly or indirectly cause alteration in the character or use of historic properties 

protected under the National Historic Preservation Act. In general, common agricultural 

activities conducted under this action do not have the potential to introduce visual, 

atmospheric, or audible elements to areas where they are used that could result in effects 

on the character or use of historic properties. For example, there is potential for audible 

effects on the use and enjoyment of a historic property when common agricultural 

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

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

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

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

original condition with no further adverse effects. These cultivation practices are also 

being conducted currently throughout the canola production regions. The cultivation of 

73496 Canola does not inherently change any of these agronomic practices in way that 

would cause any impact under the NHPA.
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 of 1973.

As described in Chapter 6 of the EA, APHIS has analyzed the potential for effects from a 

determination of nonregulated status of 73496 Canola on federally-listed threatened and 

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

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

Species Act. After reviewing possible effects of a determination of nonregulated status 

of 73496 Canola, APHIS has concluded that a determination of nonregulated status of 

73496 Canola would have no effect on federally listed TES and species proposed for 

listing, or on designated critical habitat or habitat proposed for designation.

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

imposed for the protection of the environment.

The proposed action would be in compliance with all Federal, state, and local laws. 

Because the agency has concluded that 73496 Canola is unlikely to pose a plant pest risk, 

a determination of nonregulated status of 73496 Canola is a response that is consistent 

with the plant pest provisions of the PPA, the regulations codified in 7 CFR part 340, and 

the biotechnology regulatory policies in the Coordinated Framework. Pioneer initiated 

the consultation process with FDA for the commercial distribution of 73496 Canola and 

submitted a safety and nutritional assessment of food and feed derived from 73496 

Canola to the FDA to on February 25, 2011 (Pioneer, 2011). Based on the information 

Pioneer submitted, and as of May 1, 2012, FDA has no further questions regarding 73496 

Canola (US-FDA, 2012). 73496 Canola is compositionally similar to currently available 

canola on the market. There are no other Federal, state, or local permits that are needed 

prior to the implementation of this action.

NEPA Decision and Rationale

I have carefully reviewed the EA prepared for this NEPA determination and the input from the 

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

selecting Alternative 2 (Determination that 73496 Canola is No Longer a Regulated Article). 

This alternative meets the APHIS purpose and need to allow the safe development and use of GE

organisms consistent with the plant pest provisions of the PPA.

As stated in the CEQ regulations, “the agency’s preferred alternative is the alternative which the 

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

economic, environmental, technical and other factors.” The preferred alternative has been 

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

and social factors. Based upon our evaluation and analysis, Alternative 2 is selected because (1) 

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 GE

organisms; (2) it allows APHIS to fulfill its regulatory obligations. As APHIS has not identified 
any plant pest risks associated with 73496 Canola, the continued regulated status of 73496 

Canola would be inconsistent with the plant pest provisions of the PPA, 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 73496 

Canola will not have any significant environmental effects.

_____________________________ ___________________

Michael C. Gregoire Date

Deputy Administrator

Biotechnology Regulatory Services
References

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Brookes, G., & Barfoot, P. (2010). GM Crops: Global Socio-Economic and Environmental 

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Johnson, S.R., Strom, S., & Grillo, K. (2007) Quantification of the Impacts on US 

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Pioneer. (2011). Pioneer Hi-Bred International, Inc Petition for Determination of 

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