Pioneer Hi-Bred International, Inc. Petition (11-063-

01p ) for Determination of Nonregulated Status of 

(Herbicide-Resistant 73496 Canola) 

OECD Unique Identifier: 

DP-073496-4

Environmental Assessment 

March, 2013

Agency Contact 

Cindy Eck

Biotechnology Regulatory Services

4700 River Road 

USDA, APHIS 

Riverdale, MD 20737 

Fax: (301) 734-8669

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Avenue, SW, Washington, DC 20250–9410 or call (202) 720–5964 (voice and TDD). USDA is an equal opportunity provider and employer.

Mention of companies or commercial products in this report does not imply recommendation or endorsement by the U.S. Department of 

Agriculture over others not mentioned. USDA neither guarantees nor warrants the standard of any product mentioned. Product names are 

mentioned solely to report factually on available data and to provide specific information.

This publication reports research involving pesticides. All uses of pesticides must be registered by appropriate State and/or Federal agencies 

before they can be recommended

i
1 PURPOSE AND NEED ......................................................................................................1

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

1.2 Purpose of the Product .........................................................................................................1

1.3 Coordinated Framework Review and Regulatory Review.....................................................1

1.3.1 USDA-APHIS ............................................................................................................2

1.3.2 Environmental Protection Agency...............................................................................2

1.3.3 Food and Drug Administration....................................................................................3

1.4 Purpose and Need for This APHIS Action............................................................................4

1.5 Public Involvement ..............................................................................................................4

1.5.1 First Opportunity for Public Involvement....................................................................4

1.5.2 Second Opportunity for Public Involvement ...............................................................5

1.6 Issues Considered ................................................................................................................7

2 AFFECTED ENVIRONMENT................................................................................................8

2.1 Acreage and Area of Canola Production...............................................................................8

2.1.1 Canola Production in North America ..........................................................................8

2.1.2 Agricultural Production of Canola.............................................................................13

2.1.3 Canola Seed Production............................................................................................13

2.2 Physical Environment ........................................................................................................13

2.2.1 Water Resources.......................................................................................................13

2.2.2 Soil Quality ..............................................................................................................14

2.2.3 Air Quality................................................................................................................14

2.2.4 Climate Change ........................................................................................................15

2.3 Biological Resources .........................................................................................................15

2.3.1 Animal Communities................................................................................................15

2.3.2 Plants Communities..................................................................................................16

2.3.3 Microorganisms........................................................................................................18

2.3.4 Biodiversity ..............................................................................................................18

2.4 Human Health....................................................................................................................19

2.4.1 Consumer Health ......................................................................................................19

2.4.2 Worker Health ..........................................................................................................20

2.5 Animal Feed ......................................................................................................................21

i
TABLE OF CONTENTS (Continued)

2.6 Socioeconomics.................................................................................................................21

2.6.1 Domestic Canola Production.....................................................................................21

2.6.2 Organic Farming.......................................................................................................23

2.6.3 Foreign Trade ...........................................................................................................24

3 ALTERNATIVES..................................................................................................................26

3.1 No-action Alternative: Continuation as a Regulated Article...............................................26

3.2 Preferred Alternative: Pioneer 73496 Canola is No Longer a Regulated Article ................26

3.3 Alternatives Considered But Rejected from Further Consideration.....................................27

3.3.1 Prohibit Any Pioneer 73496 Canola from Being Released.........................................27

3.3.2 Approve the Petition in Part ......................................................................................27

3.3.3 Production/Geographical Restrictions to Isolate 73496 Canola from Non-GE Canola27

3.3.4 Requirement of Testing for 73496 Canola.................................................................28

3.3.5 Comparison of Alternatives ......................................................................................28

4 ENVIRONMENTAL CONSEQUENCES..............................................................................37

4.1 Scope of Analysis ..............................................................................................................37

4.2 Acreage and Area of Canola Production.............................................................................37

4.2.1 Agricultural Production of Canola.............................................................................39

4.2.2 Organic Canola Production .......................................................................................53

4.3 Physical Environment ........................................................................................................54

4.3.1 Water Resources.......................................................................................................54

4.3.2 Soil Quality ..............................................................................................................56

4.3.3 Air Quality................................................................................................................59

4.3.4 Climate Change ........................................................................................................60

4.4 Biological Resources .........................................................................................................62

4.4.1 Animal Communities................................................................................................62

4.4.2 Plant Communities....................................................................................................63

4.4.3 Microorganisms........................................................................................................66

4.4.4 Biodiversity ..............................................................................................................68

4.5 Human Health....................................................................................................................69

4.5.1 Consumer Health ......................................................................................................69

4.5.2 Worker Health ..........................................................................................................71

4.6 Animal Feed ......................................................................................................................72

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TABLE OF CONTENTS (Continued)

4.7 Socioeconomic Impacts .....................................................................................................73

4.7.1 Domestic production of canola..................................................................................73

4.7.2 Organic Market for Canola .......................................................................................75

4.7.3 Trade Economic Environment...................................................................................76

5 CUMULATIVE IMPACTS....................................................................................................79

5.1 Assumptions Used for Cumulative Impacts Analysis .........................................................79

5.2 Past and Present Actions....................................................................................................79

5.3 Reasonably Foreseeable Actions........................................................................................82

5.4 Cumulative Impacts Summary ...........................................................................................82

6 THREATENED AND ENDANGERED SPECIES.................................................................84

6.1 Potential Effects of Pioneer 73496 Canola on TES and Critical Habitat..............................86

6.2 Potential Impacts of Glyphosate Use on TES and Critical Habitat......................................87

7 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND TREATIES 

RELATING TO ENVIRONMENTAL IMPACTS....................................................................89

7.1 Executive Orders with Domestic Implications....................................................................89

7.2 International Implications ..................................................................................................90

7.3 Compliance with Clean Water Act and Clean Air Act ........................................................92

7.4 Impacts on Unique Characteristics of Geographic Areas....................................................92

7.5 National Historic Preservation Act (NHPA) of 1966 as Amended ......................................94

8 REFERENCES ......................................................................................................................95

9 LIST OF PREPARERS ........................................................................................................113

APPENDIX A. APHIS THREATENED AND ENDANGERED SPECIES DECISION TREE 

FOR U.S. FISH AND WILDLIFE SERVICE CONSULTATIONS.........................................114

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LIST OF FIGURES

Figure 1: Canola Growing Regions of Canada and the U.S........................................................11

Figure 2: Major Canola-growing Region of North Dakota.........................................................12

Figure 3: U.S. Canola Oil Production 1987-2009.......................................................................38

Figure 4: Changes in Adoption of HR-Canola Varieties by Canadian Growers Since 1995........39

Figure 5: Ten-year Projection of Herbicide-resistant Canola Market Growth in the U.S. and 

Canada. .....................................................................................................................................49

Figure 6: Distribution of Glyphosate-resistant Weeds in the U.S. ..............................................65

Figure 7: U.S. Canola Acreage: 1991-1012 ...............................................................................73

Figure 8: U.S. Exports of Canola 2007-2012 ..........................................................................77

Figure 9: Canola Seed Quantities in the U.S. ............................................................................78

Figure 10: Oklahoma Canola Acres Planted from 2009-2012 ....................................................83

LIST OF TABLES

Table 1: Total U.S. Canola Acreage, 1991-2011..........................................................................9

Table 2: Weed Species in North Dakota Canola ........................................................................16

Table 3: Canola Acreage Planted and Harvested in the U.S.: 2011-2012....................................22

Table 4: Summary of Issues of Potential Impacts and Consequences of Alternatives. ................29

Table 5: Guide to Timing of Canola Rotation Crops..................................................................42

Table 6: Herbicide Plant-back Restrictions for Canola...............................................................44

Table 7: Seed Treatments Registered for Use on Canola............................................................47

Table 8: Registered Herbicides Commonly Used on Canola in the U.S.....................................50

Table 9: Registered Herbicides for Herbicide-resistant Canola ..................................................50

Table 10: Herbicide Resistant Weeds of 25 Canola Producing States ........................................52

Table 12: Herbicides and Application Methods Used in North Dakota Canola Production in 

20081.........................................................................................................................................64

Table 13: Canola Price/Hundred Weight and Value of U.S Production for 2009-2011...............74

Table 14: Harvested and Value of Sales from Certified Organic Canola Farms in 2008.............76

iv
ACRONYMS AND ABBREVIATIONS

AIA

AMPA

advanced informed agreement

aminomethylphosphonic acid

AOSCA American Organization of Seed Certifying Agencies

APHIS Animal and Plant Health Inspection Service

BMP

BRAD

Best Management Practice

Biopesticide Registration Action Document

BRS Biotechnology Regulatory Services (within USDA–APHIS)

Bt Bacillus thuringiensis protein

CAA Clean Air Act

CBD Convention on Biological Diversity

CEQ Council on Environmental Quality

CFR Code of Federal Regulations (United States)

CH4 methane

CO carbon monoxide

CO2 carbon dioxide

DNA deoxyribonucleic acid

DT drought tolerant

EA environmental assessment

EIS environmental impact statement

EO Executive Order

EPA U.S. Environmental Protection Agency

ESA Endangered Species Act of 1973

FDA U.S. Food and Drug Administration 

FFDCA Federal Food, Drug, and Cosmetic Act

FFP food, feed, or processing

FIFRA

FQPA

Federal Insecticide, Fungicide, and Rodenticide Act

Food Quality Protection Act

FR Federal Register

GDP gross domestic product

v
ACRONYMS AND ABBREVIATIONS

GE genetically engineered

GHG greenhouse gas

GR glyphosate-resistant

GRAS

HED

IP

generally recognized as safe

EPA Health Effects Division

Identity Preservation

IPCC Intergovernmental Panel on Climate Change

IRM Insect Resistance Management

ISPM International Standard for Phytosanitary Measure

IPPC International Plant Protection Convention

LD50

M

NGO

lethal dose that kills 50% of the animals being tested

Million

non-government organization

NO2 nitrogen dioxide

N2O nitrous oxide

NAAQS National Ambient Air Quality Standards

NABI North American Biotechnology Initiative

NAPPO North American Plant Protection Organization

NEPA National Environmental Policy Act of 1969 and subsequent amendments

NHPA National Historic Preservation Act

NOEL no observable effect level

NRC National Research Council

PPRA Plant Pest Risk Assessment

PPA

PPM

Plant Protection Act

parts per million

PRA pest risk analysis

RNA ribonucleic acid

TES threatened and endangered species

TSCA Toxic Substances Control Act

U.S. United States

USDA U.S. Department of Agriculture

USDA-ERS U.S. Department of Agriculture-Economic Research Service

vi
ACRONYMS AND ABBREVIATIONS

USDA-FAS U.S. Department of Agriculture-Foreign Agricultural Service

USDA-NASS U.S. Department of Agriculture-National Agricultural Statistics Service

USDA-NOP U.S. Department of Agriculture-National Organic Program

USC United States Code

WPS Worker Protection Standard for Agricultural Pesticides

vii
1 PURPOSE AND NEED

1.1 Background

Pioneer Hi-Bred International, Inc. of Johnston, IA (henceforth referred to as Pioneer) submitted 

petition 11-063-01p to the United States Department of Agriculture (USDA) Animal and Plant 

Health Inspection Service (APHIS) in February 2011 (Pioneer, 2011). The purpose of the 

petition is to support a determination of nonregulated status for Pioneer 73496 Canola 

(henceforth referred to as 73496 canola), which is resistant1 to the herbicide, glyphosate. The

73496 canola variety is currently regulated under Title 7 of the Code of Federal Regulations (7 

CFR) part 340. Interstate movement and field trials of 73496 canola have been conducted under 

permits issued or notifications acknowledged by APHIS since 2007. These field trials were 

conducted within selected canola-growing areas in the U.S., including California, Idaho, 

Minnesota, New Jersey, North Dakota and Washington. Data resulting from these field trials are 

described in the 73496 petition (Pioneer, 2011) and analyzed for plant pest risk in the USDAAPHIS Plant Pest Risk Assessment (PPRA) (USDA-APHIS, 2013).

The petition stated that APHIS should not regulate 73496 canola because it does not present a 

plant pest risk. If a determination of nonregulated status is made, it would include 73496 canola, 

any progeny derived from crosses between73496 canola and conventional canola, and crosses of 

73496 canola with other biotechnology-derived canola lines that are no longer subject to the 

regulatory requirements of 7 CFR part 340 promulgated under the authority of the Plant 

Protection Act of 2000 (PPA).

1.2 Purpose of the Product

Pioneer 73496 Canola provides growers with an alternative to existing GR (glyphosate-resistant)

canola products on the market today. 73496 canola will provide similar benefits to currently 

available GR canola varieties by allowing post emergent applications of glyphosate to control 

weeds. 

1.3 Coordinated Framework Review and Regulatory Review

Since 1986, the United States government has regulated genetically engineered (GE) organisms 

pursuant to Federal regulations published in the Federal Register (51 FR 23302; 57 FR 22984)

1

Resistance to herbicides is defined by HRAC (Herbicide Resistance Action Committee) as the inherited ability of a 

plant population to survive and reproduce following repeated exposure to a dose of herbicide normally lethal to the 

wild type HRAC, Guideline to the Management of Herbicide Resistance, 2013, Herbicide Resistance Action 

Committee, Available: http://www.hracglobal.com/Publications/ManagementofHerbicideResistance.aspx, January 

22 2013. Resistance may be induced by genetic engineering or selection of variants produced by tissue culture or 

mutagenesis. HRAC, Guideline to the Management of Herbicide Resistance. This is to be distinguished from 

tolerant, which is defined by HRAC as the inherent ability of a plant to survive and reproduce after herbicide 

treatment. This implies that there was no selection or genetic manipulation to make the plant tolerant; it is naturally 

tolerant. HRAC, Guideline to the Management of Herbicide Resistance. Developers may use these terms 

differently. “Herbicide-Tolerant” is a term used by the petitioner to be synonymous with “herbicide resistant” as it 

is used in this document.

1

 
entitled The Coordinated Framework for the Regulation of Biotechnology (henceforth referred to 

here as the Coordinated Framework). The Coordinated Framework, published by the Office of 

Science and Technology 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 Environmental Protection 

Agency (EPA), and the Food and Drug Administration (FDA). A summary of each role follows:

1.3.1 USDA-APHIS

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 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 7 CFR 340, when APHIS has reason to believe that the GE organism may be a 

plant pest or APHIS does not have information to determine if the GE organism is unlikely to 

pose a plant pest risk. 

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

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

provisions of the PPA or the regulations at 7 CFR 340. Under § 340.6(c)(4), the petitioner must 

provide information related to plant pest risk that the agency can use to determine whether the 

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

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

pest provisions of the PPA when APHIS determines that it is unlikely to pose a plant pest risk.

1.3.2 Environmental Protection Agency

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. The 

EPA regulates plant incorporated protectants (PIPs) under the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq.) and certain biological control organisms under 

the Toxic Substances Control Act (TSCA) (15 U.S.C. 53 et seq.). Before planting a crop 

containing a PIP, a company must seek an experimental use permit from EPA. Commercial 

2
production of crops containing PIPs for purposes of seed increases and sale requires a FIFRA 

Section 3 registration with EPA. 

Under FIFRA (7 U.S.C. 136 et seq.), EPA regulates the use of pesticides, and requires 

registration of all pesticide products for all specific uses prior to distribution for sale. EPA 

examines: the ingredients of the pesticide; the particular site or crop on which it is to be used; the 

amount, frequency, and timing of its use; storage and disposal practices. Prior to registration for 

a new use for a new or previously registered pesticide, EPA must determine through testing that 

the pesticide does not cause unreasonable adverse effects on humans, the environment, and nontarget species when used in accordance with label instructions. EPA must also approve the 

language used on the pesticide label in accordance with 40 CFR part 158. Once registered, a 

pesticide may only be legally used in accordance with directions and restrictions on its label. 

The overall intent of the label is to provide clear directions for effective product performance,

while minimizing risks to human health and the environment. The Food Quality Protection Act 

(FQPA) of 1996 amended FIFRA, enabling EPA to implement periodic registration review of 

pesticides to ensure they are meeting current scientific and regulatory standards of safety and 

continue to have no unreasonable adverse effects (US-EPA, 2011c). 

EPA also sets tolerances (maximum residue levels) or establishes an exemption from the 

requirement for a tolerance, under the Federal Food, Drug, and Cosmetic Act (FFDCA). A 

tolerance is the amount of pesticide residue that can remain on or in food for human consumption 

or animal feed. Before establishing a pesticide tolerance, EPA is required to reach a safety 

determination based on a finding of reasonable certainty of no harm under the FFDCA, as 

amended by the FQPA. FDA enforces the pesticide tolerances set by EPA.

1.3.3 Food and Drug Administration

FDA regulates GE organisms under the authority of the FFDCA (21 U.S.C. 301 et seq.). The 

FDA published its policy statement concerning regulation of products derived from new plant 

varieties, including those derived from genetic engineering, on May 29, 1992 (57 FR 22984). 

Under this policy, FDA implements a voluntary consultation process to ensure that human food 

and animal feed safety issues or other regulatory issues, such as labeling, are resolved before 

commercial distribution of bioengineered food. This voluntary consultation process provides a 

way for developers to receive assistance from FDA in complying with their obligations under 

Federal food safety laws prior to marketing.

More recently (June 2006), FDA published recommendations in “Guidance for Industry: 

Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins 

Produced by New Plant Varieties Intended for Food Use” (US-FDA, 2006). This establishes

voluntary food safety evaluations for new non-pesticidal proteins produced by new plant 

varieties intended to be used as food, including 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 information may be used later in 

the biotechnology consultation.

3
1.4 Purpose and Need for This APHIS Action

As noted in the previous section any party can petition APHIS to seek a determination of 

nonregulated status for a GE organism that is regulated under 7 CFR 340. As required by 7 CFR 

340.6, APHIS must respond to petitioners that 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. 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.

APHIS must respond to the petition from Pioneer Hi-Bred International, Inc. requesting a 

determination of nonregulated status for 73496 canola. APHIS has prepared this draft 

Environmental Assessment (EA) to consider the potential environmental effects of an agency 

determination of nonregulated status 73496 canola. This action is consistent with regulations for 

the National Environmental Policy Act (NEPA) established by the Council of Environmental 

Quality (CEQ), and the USDA APHIS NEPA-implementing regulations and procedures (40 CFR 

parts 1500-1508, 7 CFR part 1b, and 7 CFR part 372). This EA has been prepared in order to 

specifically evaluate the effects on the quality of the human environment2 that may result from a 

determination of nonregulated status for 73496 canola.

1.5 Public Involvement

APHIS routinely seeks public comment on EAs prepared in response to petitions seeking a 

determination of nonregulated status of a regulated GE organism. APHIS does this through a 

notice published in the Federal Register. On March 6, 2012, APHIS published a notice3 in the 

Federal Register advising the public that APHIS is implementing changes to the way it solicits 

public comment when considering petitions for determinations of nonregulated status for GE 

organisms to allow for early public involvement in the process. As identified in this notice, 

APHIS will publish two separate notices in the Federal Register for petitions for which APHIS 

prepares an EA. The first notice will announce the availability of the petition, and the second 

notice will announce the availability of APHIS’ decision making documents. As part of the new 

process, with each of the two notices published in the Federal Register, there will be an 

opportunity for public involvement:

1.5.1 First Opportunity for Public Involvement

Once APHIS deems a petition complete, the petition is made available for public comment for 60 

days, providing the public an opportunity to raise issues regarding the petition itself and give 

2 Under NEPA regulations, the “human environment” includes “the natural and physical environment and the 

relationship of people with that environment” (40 CFR §1508.14).

3

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

4

 
input that will be considered by the Agency as it develops its EA and PPRA. APHIS publishes a 

notice in the Federal Register to inform the public that APHIS will accept written comments

regarding a petition for a determination of nonregulated status for a period of 60 days from the 

date of the notice. This availability of the petition for public comment will be announced in 

a Federal Register notice.

1.5.2 Second Opportunity for Public Involvement

Assuming an EA is sufficient, the EA and PPRA are developed and a notice of their availability 

is published in a second Federal Register notice. This second notice follows one of two 

approaches for public participation based on whether or not APHIS decides the petition for a 

determination of nonregulated status is for a GE organism that raises substantive new issues:

Approach 1: GE organisms that do not raise substantive new issues.

This approach for public participation is used when APHIS decides, based on the review of the 

petition and our evaluation and analysis of comments received from the public during the 60-day 

comment period on the petition, that the petition involves a GE organism that does not raise new 

biological, cultural, or ecological issues because of the nature of the modification or APHIS' 

familiarity with the recipient organism. After developing its EA, finding of no significant impact 

(FONSI), and PPRA, APHIS publishes a notice in the Federal Register announcing its 

preliminary regulatory determination and the availability of the EA, FONSI, and PPRA for a 30-

day public review period.

If APHIS determines that no substantive information has been received that would warrant 

APHIS altering its preliminary regulatory determination or FONSI, substantially changing the 

proposed action identified in the EA, or substantially changing the analysis of impacts in the 

EA, APHIS' preliminary regulatory determination becomes final and effective upon public 

notification through an announcement on its website. No further Federal Register notice is

published announcing the final regulatory determination.

Approach 2. For GE organisms that raise substantive new issues not previously reviewed by 

APHIS. A second approach for public participation is used when APHIS determines that the 

petition for a determination of nonregulated status is for a GE organism that raises substantive 

new issues. This could include petitions involving a recipient organism that has not previously 

been determined by APHIS to have nonregulated status or when APHIS determines that gene 

modifications raise substantive biological, cultural, or ecological issues not previously analyzed 

by APHIS. Substantive issues are identified by APHIS based on our review of the petition and 

our evaluation and analysis of comments received from the public during the 60-day comment 

period on the petition. 

APHIS solicits comments on its draft EA and draft PPRA for 30 days through the publication of

a Federal Register notice. APHIS reviews and evaluates comments and other relevant 

information, then revises the PPRA as necessary and prepares a final EA. Following preparation 

of these documents, APHIS approves or denies the petition, announcing in the Federal Register

the regulatory status of the GE organism and the availability of APHIS' final EA, PPRA, 

National Environmental Policy (NEPA) decision document (either a FONSI or NOI to prepare 

an EIS), and regulatory determination.

5
Enhancements to public input are described in more detail in the Federal Register notice4

published on March 6, 2012.

APHIS has determined that this EA will follow Approach 1. The issues discussed in this EA 

were developed by considering the public concerns, including public comments received in 

response to the Federal Register notice (77 F.R. 41364-6) announcing the availability of the 

petition (i.e., the first opportunity for public involvement previously described in this document), 

as well as issues noted in public comments submitted for other EAs of GE organisms, and 

concerns described in lawsuits and expressed by various stakeholders. These issues, including 

those regarding the agricultural production of canola using various production methods and the 

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

environmental impacts of 73496 canola.

The public comment period for Pioneer 73496 Canola petition closed on September 11, 2012. 

At its closing, the docket file contained a total of 86 public submissions. Some of the 

submissions to the docket contained multiple attached comments gathered by organizations from 

their members Contained within the 86 submissions were a total of 4,686 public comments. The 

majority of the comments expressed a general dislike of the use of GE organisms or were form

letters sent to all of the dockets which were open at the time that this docket was open. The form 

letter expressed a concern that there were too many dockets published on the same day. It also 

referenced other open dockets and potential effects from the use of the subjects of those 

petitions. These issues are outside the scope of this EA. 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 also included 

a discussion of these issues in this EA.

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

6

 
1.6 Issues Considered

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

considering public concerns and issues raised in public comments submitted for this petition and 

other EAs of GE organisms. The resource areas considered also address concerns raised in 

previous and unrelated lawsuits, as well as issues that have been raised by various stakeholders 

for this petition and in the past. The resource areas considered in this EA can be categorized as 

follows: 

Agricultural Production Considerations:

• Acreage and Areas of Canola Production

• Agronomic/Cropping Practices

• Canola Seed Production

Environmental Considerations:

• Soil Quality

• Water Resources

• Air Quality 

• Climate Change

• Animal Communities

• Plant Communities

• Microorganisms

• Biological Diversity

Human Health Considerations:

• Consumer Health

• Worker Safety

Livestock Health Considerations:

• Animal Feed/Livestock Health

Socioeconomic Considerations:

• Domestic Economic Environment 

• Organic Canola Production

• Trade Economic Environment

7
2 AFFECTED ENVIRONMENT

This section includes a review of the prevailing conditions of the affected environment that 

might be impacted by canola production. Relevant environmental components include 

agricultural production area of canola, the physical environmental, biological resources, human

health, animal feed, and socioeconomic resources.

2.1 Acreage and Area of Canola Production

The first commercial seed of this variety of rapeseed (Brassica rapa), which is referred to as 

“Oro,” was released in 1966. The product from this cultivar had low animal palatability caused 

by high endogenous levels of glucosinolates, so it had limited use as meal for feed. Another B. 

rapa cultivar with lower glucosinolate levels was subsequently identified. The first low erucic 

acid, low glucosinolate cultivar, “Tower,” was released for commercialization in 1974.

In 1978, the Canola Council of Canada established a performance standard for these “double 

low” varieties and chose the vernacular name “canola” to describe them. By definition, canola 

oil contains less than 2% erucic acid and the meal contains less than 3 mg/g of glucosinolates 

(Brown et al., 2008).

In January 1985, FDA granted canola oil GRAS (Generally Recognized as Safe) status for use in 

human foods. This promoted greatly increased sales and demand in the U.S. The FDA also 

allowed the qualified health claim, “healthy oil,” for canola oil under which it is now widely 

marketed. Canola varieties have been available since 1989 (CCC, 2003), and canola is currently 

grown worldwide.

To date, traditional, non-GE plant breeding methods have been used to produce varieties of three 

Brassica species that meet the low erucic acid, low glucosinolate canola definition: 

• Brassica rapa—common name: Polish canola;

• Brassica napus—common name: Argentine canola;

• Brassica juncea—common name: canola quality brown mustard.

In the U.S. three different types of canola are grown:

• Winter canola (planted in fall; harvested in spring) that requires vernalization (winter 

chilling to promote spring flowering);

• Winter canola that does not require vernalization;

• Spring canola (planted in the spring and harvested in the fall).

To achieve optimal production, it is recommended that winter canola be planted about six weeks

before the first killing frost, which is defined as lower than 25°F (Atkinson et al., 2006). During 

winter, plants enter a dormant phase that is typically indicated by development of red/purplecolored leaves. Growth resumes in spring as temperatures rise above 55-60°F (Atkinson et al., 

2006).

2.1.1 Canola Production in North America

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. Figure 1 illustrates that most of this region is in the prairie 

8
provinces of Canada, but part of it extends into North Dakota. During the decade, 2001-2010 the

canola production in the U.S. averaged 1.2M (million) acres (Table 1).

Table 1: Total U.S. Canola Acreage, 1991-2011

Total U.S. Canola Acreage, 1991-2011

Year Planted Acres

(1,000 Acres)

Yield per Acre

(lbs.)

Production

(1,000 lbs.)

1991 155 1,300 191,100

1992 140 1,286 144,037

1993 199 1,350 252,450

1994 354 1,316 447,440

1995 446 1,278 548,447

1996 367 1,385 480,521

1997 671 1,237 780,710

1998 1,115 1,448 1,557,800

1999 1,076 1,306 1,363,680

2000 1,555 1,334 1,998,310

2001 1,494 1,374 1,998,515

2002 1,460 1,197 1,533,420

2003 1,082 1,416 1,512,250

2004 865 1,618 1,339,530

2005 1,159 1,419 1,580,985

2006 1,044 1,366 1,394,312

9
2007 1,176 1,238 1,430,734

2008 1,011 1,461 1,445,064

2009 827 1,811 1,474,130

2010 1,449 1,713 2,450,947

2011 1,072 1,475 1,538,010

2012 1,765 1,416 2,447,410

Source: USDA-NASS, 2010; USDA-NASS, 2012

10
Figure 1: Canola Growing Regions of Canada and the U.S. 

Most of the canola produced in North America is produced in Canada. Production in the U.S. is mainly in North

Dakota where more than 90% of the U.S. canola crop is produced. Dark yellow shading delineates the region where 

canola is a major crop. Light yellow shading delineates canola-growing regions where canola is rotated with other

crops, but is not a major crop of that region. This map does not show regions, like the Southeastern U.S., where few 

growers produce canola

11
Land use

In the U.S. there are over 900M acres of farmland. About 1/3 of that land is harvested cropland. 

Harvested cropland includes field, vegetable, and forage crops. Canola is produced on 

approximately 0.04% of the harvested cropland in the U.S. It is a minor crop that is primarily 

grown in North Dakota. There are 22M acres of harvested cropland in North Dakota, but only 

slightly less than 5% of that is planted in canola, so it is not even one of the top five crops 

planted in that state. Cavalier County, North Dakota has more canola acreage than any other 

county in the U.S. In this county, canola is the second largest crop by acres according to the 

2007 Census of Agriculture. Thirteen counties in North Dakota produce 75% of U.S. canola 

(Figure 2).

Figure 2: Major Canola-growing Region of North Dakota. 

Approximately 3⁄4 of the U.S. canola crop is grown in thirteen counties (shaded) in ND. Note (cf. Figure 1) that 

these counties are conterminous within the primary North American canola-growing region, most of which is in 

western Canada.

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2.1.2 Agricultural Production of Canola

Most canola grown in the U.S. is spring canola. It requires an average of 100-125 days from 

seeding to harvesting. Canola grows best in a temperature range of 54-86°F (12-30oC). The 

optimal average temperature for maximum growth and development is 68°F (20oC) (Brown et 

al., 2008).

Spring canola is planted in early spring (typically March) and is harvested in late summer or 

early autumn (usually September or October). In the U.S., it is grown primarily in states with a 

cooler climate (e.g, North Dakota, Minnesota).

Winter canola is typically planted in the Pacific Northwest, Midwest, and Great Plains. It 

requires vernalization to flower, so it needs to overwinter. Winter canola that is planted in the 

southeast region of the U.S. also overwinters, but does not require vernalization (Brown et al., 

2008). Winter canola is typically planted in September and harvested in June or July. It is 

grown on fewer acres than spring canola, but can be grown in a broader range of environments, 

particularly where winters are mild. 

2.1.3 Canola Seed Production

Favorable conditions for canola seed production include fertile soil, dry weather, access to

irrigation, appropriate temperatures, and adequate distance from commercial canola production

areas. Based on these constraints, most canola seed produced for sale for the North American

market is produced in the summer in a small geographic area in southern Alberta, Canada and

the northwestern U.S. Most of this is near Lethbridge, Alberta and there is a growing industry in 

the Maritime Provinces (Davison, 2005). Among U.S. areas, summer seed production occurs 

in the Columbia Basin in eastern Washington (Wohleb, 2009), the Grand Ronde Valley in 

Union County in northeastern Oregon (Wohleb, 2009). Canola seed may also be produced in 

other areas.

To meet the demand for seed and to minimize production risks, most seed companies have

off-season seed production locations in the southwestern U.S. (Imperial Valley, California and

Yuma Valley, Arizona (Nolte, No Date) and Chile (HITech Production, no date).

Based on an average canola seeding rate of five pounds per acre, approximately 7.5 M pounds

(3,400 metric tons) of canola seed is required to plant the approximately 1.5M-acre U.S. crop. 

With allowances for seed losses caused by weather, poor yields, quality issues, distribution 

excess, seed returns and replants, approximately 5,000 acres of commercial seed production are

needed to supply sufficient seed to plant the entire U.S. canola acreage. Production of seed for 

winter canola, to grow in the more southern areas of the U.S. is located in Kentucky and Virginia

(MD-Cooperative-Extension-Service, 1991). These varieties are distinct from those grown in the 

northern U.S. and Canada, so are not the focus of much of the commercial seed industry.

2.2 Physical Environment

2.2.1 Water Resources

Surface water in rivers, streams, creeks, lakes, and reservoirs supports everyday life by providing 

water for drinking and other public uses, irrigation, and industry (USGS, 2011). In 2005, about 

13
77% of the freshwater used in the U.S. was derived from surface water. Groundwater sources 

account for the remaining 23% (USGS, 2011).

A significant amount of the U.S. water supply is used for agricultural purposes. It accounts for 

approximately 40% of water withdrawn from U.S. surface and groundwater sources. Most of 

this is for crop irrigation (CAST, 2009). Although the proportion of available freshwater used in 

agriculture varies widely among geographic areas, it is a major proportion of water use in all

areas.

Agricultural NPS (non-point-source) pollution is the primary source of pollutants discharged into

rivers and lakes. It is also a major contributor to groundwater contamination (US-EPA, 2005). 

Agricultural activities that cause NPS pollution include poorly located or managed animal 

feeding operations; overgrazing leading to soil erosion; too frequent and/or poorly timed 

plowing; improper, excessive, or poorly timed application of pesticides, irrigation water, or

fertilizer. The pollutants that result from agricultural practices include sediment, nutrients, 

pathogens, pesticide residue, metals, and salts (US-EPA, 2005).

2.2.2 Soil Quality

The Soil Science Society of America defines soil as the unconsolidated mineral or organic 

material on the immediate surface of the Earth that serves as a natural medium for the growth of 

land plants (Soil-Science-Society-of-America, 2013).

Soil quality is the capacity of a specific kind of soil to sustain plant and animal productivity, 

maintain or enhance water and air quality, and support human health and habitation (USDANRCS, No Date-b). Several indicators used to measure soil quality include: soil organic matter, 

pH, water holding capacity, soil structure, microbial biomass and soil respiration (USDA-NRCS, 

No Date-a). A more detailed discussion of soil quality and health can be found on the National 

Resources Conservation Service Soils website (USDA-NRCS, 2013). 

The northern Great Plains region of North America is recognized as having some of the world’s 

most fertile soils, (Doran et al., 1996). However, the region is also subject to climatic extremes 

that include severe droughts, flash-flooding and intense summer heat and winter cold. For 

example, the all-time North Dakota record high temperature (121 ͦF) and record low (-60 ͦF) were 

set less than six months apart in 1936. Such climatic events can exacerbate crop production 

impacts on soil quality.

2.2.3 Air Quality

Dry air consists of about 78% nitrogen, 21% oxygen, 0.9% argon and 0.03% carbon dioxide. It 

also contains small amounts of water vapor and particulate matter. Air quality can affect the 

growth of plants in agricultural systems (Darley and Middleton, 1966) as well as human and 

animal health.

Agronomic practices used in agriculture affect air quality. Tillage exposes soil to wind erosion 

and utilizes motorized equipment that produces emissions. The use of herbicide-resistant crops 

has facilitated the adoption of conservation tillage (Towery and Werblow, 2010). Reduced 

tillage generates fewer particulates (dust), so potentially contributes to lower rates of wind 

14
erosion and release of soil particulates into the air, thus, benefitting air quality (Fawcett and 

Towery, 2002). Conservation tillage also minimizes the use of mechanized equipment that 

produces exhaust, so reduces emissions.

2.2.4 Climate Change

Climate change represents a significant, sustained statistical change in average weather 

conditions over a broad region. EPA has identified CO2, methane (CH4), and nitrous oxide 

(N2O) as the most important GHGs (greenhouse gases) contributing to climate change. While 

each of these occurs naturally in the atmosphere, human activity has significantly increased their

concentration since the beginning of the industrial revolution. The level of human-produced 

gases has been accelerating since the end of World War II, when industrial and consumer 

consumption expanded greatly. Since the advent of the industrial age, the percent increase in the 

concentration of some important GHGs are as follows: CO2, 36; CH4,, 148 and N2O, 18 (USEPA, 2011b).

Agriculture, including land-use changes for farming, is estimated to be responsible for 8% of all 

human-induced GHG emissions in the U.S. (Massey and Ulmer, 2010). Many agricultural 

activities affect air quality, including smoke from agricultural burning, machinery, and N2O 

emissions from the use of nitrogen fertilizer (Hoeft et al., 2000; Aneja et al., 2009; U.S. EPA, 

2010b). Emissions released from agricultural equipment (e.g, irrigation pumps and tractors) 

include carbon monoxide, nitrogen oxides, reactive organic gases, particulate matter, and sulfur 

oxides (U.S. EPA, 2010b). Tillage contributes to GHG production because it releases CO2 

sequestered in soil and promotes oxidation of soil organic matter (Baker et al., 2005).

2.3 Biological Resources

This section provides a summary of the biological environment and includes an overview of 

animals, plants, microorganisms, and biodiversity associated with canola production. This 

summary provides the foundation to assess the potential impact to plant and animal communities, 

the potential for gene movement, and the potential for human health impacts. 

2.3.1 Animal Communities

The specific animals that are found in and around canola fields vary depending on field location 

and season of the year. Winter and spring canola fields may also attract different organisms 

because they are planted during different times of the year. Birds and small mammals may be 

associated with canola fields. Birds, such as geese or blackbirds, may feed on canola (Boyles et 

al., 2012). Voles, squirrels, and deer mice may also be found in or around canola fields and may 

feed on canola seed (Bayne and Hobson, 1998). It is likely that predators (e.g., reptiles) of small 

mammals also use canola fields and surrounding areas as hunting grounds. If water ways are 

near canola fields, aquatic organisms such as fish and amphibians may be part of the animal 

community. 

Invertebrate organisms that feed on canola plants include cutworms, diamondback moths, flea 

and blister beetles, grasshoppers, true bugs, aphids, and armyworms (NDSU, 2011). The yellow 

flowers of canola can also attract pollinators. Honey bees, bumble bees and leafcutter bees may 

15
all visit canola (Scott-Dupree et al., 2009). Many local native pollinators may also visit fields 

when they are flowering (Gavloski, 2012). 

2.3.2 Plants Communities

Plant associations with canola production include within-field and outside-of-field communities. 

Within-field communities include canola as well as any weeds of canola that may be found in the 

field. Within-field communities can also include crops that are rotated with canola and the 

weeds of those crops. Within-field weeds can be volunteers from a crop that is grown in rotation 

with canola. Within field weeds can also come from weeds that were not well controlled in the 

previous crop.

Out-of-field communities include plants in neighboring agricultural fields and native or 

naturalized species in the field margins and surrounding landscape. Some of the out-of-field 

plant communities can serve as sources of weeds in within-field communities. 

Common weeds of canola include volunteers from rotation crops, for example wheat and barley 

(CCC, 2003; Harker et al., 2008). Table 2 identifies weeds that are found in canola fields in 

North Dakota, where most U.S. canola is grown. Weeds of the Brassicaceae family can 

contaminate the crop and reduce oil and meal quality (CCC, 2003). They produce large numbers 

of seeds; some weed seeds have prolonged dormancy, which allows a build-up of weed 

populations (CFIA, 1994; OECD, 1997; CCC, 2003). Such closely related weeds of the

Brassicaceae family include wild mustard (Sinapis arvensis), field pennycress (Thlaspi arvense), 

shepherd’s purse (Capsella bursa-pastoris), ball mustard (Neslia paniculata), flixweed 

(Descurainia sophia), wormseed mustard (Erysimum cheiranthoides), hare’s ear mustard 

(Coringia orientalis), and common peppergrass (Lepidium densiflorum) (CFIA, 1994; OECD, 

1997; CCC, 2003). Other weeds include cleavers (Galium aparine), stork’s bill (Erodium 

circutarum), and quackgrass (Elytrigia repens) (CCC, 2003).

Predominant weed species found in North Dakota canola fields during a survey in 2000 

(Zollinger et al., 2003) are listed in Table 2.

Table 2: Weed Species in North Dakota Canola

Weed Species in North Dakota Canola

Common Name

Scientific Name Weed Frequency 

(%)1

Wild oat Avena fatua L. 53

Kochia Kochia scoparia (L.) Schrod. 53

Canada thistle Cirsium arvense (L.) Scop. 42

16
Wild mustard Sinapis arvensis (L.) 37

Perennial sowthistle Sonchus arvensis L. 26

Volunteer cereals Hordeum vulgare L., Triticum aestivum Desf., Avena 

sativa L. 16

Flixweed / Tansy 

mustard

Descurainia sophia (L.) Webb./ Descurainia pinnata

(Walt.) Britt 6

Common 

lambsquarters Chenopodium album L. 16

Quackgrass Elytrigia repens (L.) Neyski. 11

Green foxtail Setaria viridis (L.) Beauv. 11

Common ragweed Ambrosia artemisiifolia L. 11

Common sunflower Helianthus annuus L. 11

Wild buckwheat Polygonum convolvulus L. 5

Pigweed species Amaranthus species 5

Barnyardgrass Echinochloa crus-galli (L.) Beauv 5

Common cocklebur Xanthium pensylvanicum Wallr. 5

Field pennycress Thlaspi arvense L. 5

1

Weed frequency is the percentage of fields surveyed that contained the weed species in one or more sample 

quadrants.

A 1997 survey conducted in Montana indicated that kochia, wild buckwheat, Canada thistle, 

annual mustards, wild oats, and volunteer grain were the most prevalent weeds in canola (Petroff 

and Miller, 1999). Both the winter and summer complex of weeds occur in canola in Kentucky. 

Wild garlic bulblet, common chickweed, henbit, yellow rocket, Johnson grass and volunteer 

wheat can be found in canola. Volunteer corn, annual ryegrass and thistles have also been 

identified in Kentucky canola fields according to a 2010 survey (Johnson et al., 2010).

Canola can form feral populations and has been found along field margins, road sides, and other 

disturbed habitats (Crawley and Brown, 1995; Schafer et al., 2011).

17
B. napus can also interact with certain plants through sexual reproduction. B. napus is 

predominantly self-pollinating although interplant (plants are touching one another) cross 

pollination rates range from 12% to 55% with a mean of 30% (Beckie et al., 2003). Pollen of B.

napus is heavy and sticky (OECD, 1997), and pollen movement is primarily by insects, such as 

honey bees (Thompson et al., 1999) although wind is also responsible for some pollen 

movement. Most (98.8%) of pollen travels less than twelve meters from its source (Scheffler et 

al., 1993), although dispersal due to pollinators may occur over greater distances at low 

frequency (Thompson et al., 1999) .

B. napus produces a large amount of pollen which can remain viable for 4-5 days under field 

conditions (Rantio-Lehtimäki, 1995). This, coupled with the potential for B. napus pollen 

movement, provides the possibility for hybridization between B. napus and related sexually 

compatible species. 

2.3.3 Microorganisms

Soil microorganisms affect soil structure formation, decomposition of organic matter, 

detoxification of natural and synthetic chemical compounds, nutrient cycling, and most 

biochemical soil processes (Garbeva et al., 2004). They also suppress soil-borne plant diseases 

and promote plant growth (Doran et al., 1996). The main factors affecting microbial population 

size and diversity include soil type and plant types present, which provide specific carbon and 

energy sources in soil, and agricultural management practices (crop rotation, tillage, herbicide 

and fertilizer application, and irrigation) (Garbeva et al., 2004). Plant roots, including those of 

canola (Rumberger and Marschner, 2003), release a variety of compounds into the soil creating a 

unique environment for microorganisms in the rhizosphere. Microbial diversity in the 

rhizosphere may be extensive and differs from the microbial community in the bulk soil 

(Garbeva et al., 2004). 

2.3.4 Biodiversity

Biodiversity refers to all plants, animals, and microorganisms interacting in an ecosystem 

(Wilson, 1988b). Biodiversity provides valuable genetic resources for crop improvement 

(Harlan, 1975) and also provides other functions beyond food, fiber, fuel, and income. These 

include pollination, genetic introgression, biological control, nutrient recycling, competition 

against natural enemies, soil structure, soil and water conservation, disease suppression, control 

of local microclimate, control of local hydrological processes, and detoxification of noxious 

chemicals (Altieri, 1999). The loss of biodiversity results in a need for costly management 

practices in order to provide these functions to the crop (Altieri, 1999). 

The degree of biodiversity in an agroecosystem depends on four primary characteristics: 1) 

diversity of vegetation within and around the agroecosystem; 2) permanence of various crops 

within the system; 3) intensity of management; 4) extent of isolation of the agroecosystem from 

natural vegetation (Southwood and Way, 1970).

Agricultural land subject to intensive farming practices, such as that used in crop production, 

generally has low levels of biodiversity compared with adjacent natural areas. Tillage, seed bed 

preparation, planting of a monoculture crop, pesticide use, fertilizer use, and harvest result limit 

the diversity of plants and animals (Lovett et al., 2003).

18
Biodiversity can be maintained or reintroduced into agroecosystems through the use of woodlots, 

fencerows, hedgerows, and wetlands. Agronomic practices include intercropping (the planting 

of two or more crops simultaneously to occupy the same field), agroforestry, crop rotations, 

cover crops, no-tillage, composting, green manuring (growing a crop specifically for the purpose 

of incorporating it into the soil in order to provide nutrients and organic matter), addition of 

organic matter (compost, green manure, animal manure, etc.), and hedgerows and windbreaks 

(Altieri, 1999).

2.4 Human Health

One component of the affected environment is the direct human impacts of products derived 

from GE canola. These impacts, which are addressed in this section, are divided into two 

categories, consumer and worker health.

2.4.1 Consumer Health

Rapeseed is the traditional name for the oilseed crops in the mustard family, Brassicaceae. 

Rapeseed has been cultivated for thousands of years as a source of oil for cooking, lighting, and 

lubrication (Brown et al., 2008). In the 1940s, Canadian farmers cultivated rapeseed as a source 

of industrial lubricants, but as demand for industrial lubricants declined after World War II, two 

Canadian scientists bred B. napus to contain less erucic acid (a fatty acid that has been associated 

with heart disease) and more oleic acid (a fatty acid known to promote heart health), thereby 

improving the palatability of the oil and making it suitable for human consumption.

Any potential human health effects to consumers from glyphosate applied to GE HR canola are 

reviewed in the following section (Worker Health). Consumer health concerns about GE canola 

are primarily related to human consumption. The principal product derived from canola that is 

consumed by humans is vegetable oil. By volume, global canola oil consumption is third behind 

soybean and palm oil and second in the U.S.

According to the (OECD, 2001) canola oil has one component, erucic acid, of human health 

significance because of its toxic properties. The compound is produced normally by rapeseed 

(OECD, 2001). Varieties that produce oil with less than 2% of this fatty acid are defined as 

canola, and canola oil is categorized as GRAS by FDA (21 CFR 184). The Codex Standard for 

Named Vegetable Oils (FAO, 2009) also specifies that canola oil cannot contain more than 2% 

erucic acid.

People may be exposed to residues from pesticides used to grow canola. EPA sets tolerances for 

each pesticide that can be used on canola. These specific tolerances can be found in 40 CFR part 

180. The FFDCA mandates that before a pesticide can be used on a food crop, the EPA must 

establish a maximum residue level (tolerance). This is the maximum amount of pesticide residue 

that can remain on the crop or in foods processed from that crop (US-EPA, 2011i). The USDA 

has implemented the Pesticide Data Program (PDP) in order to collect data on pesticides residues 

on food (USDA-AMS, 2010b). The EPA uses PDP data to prepare pesticide dietary exposure 

assessments pursuant to the 1996 FQPA. Pesticide tolerances for glyphosate have been 

established for a wide variety of commodities, and are published in the Federal Register, 40 CFR 

§180.364, and the Indexes to Part 180 Tolerance Information for Pesticide Chemicals in Food 

and Feed Commodities (US-EPA, 2011d). The EPA tolerance for both canola seed and rapeseed 

is 20 ppm (parts per million).

19
Glyphosate is registered under a variety of trade names by several companies. There are 

currently over 400 active glyphosate products registered under FIFRA Section 3, and over 100 

registered for use on terrestrial food crops (US-EPA, 2009b). It is a mild eye irritant (Toxicity 

Category III5

), slight skin irritant (Toxicity Category IV), and is not a dermal sensitizer in guinea 

pigs. It has been found to have low toxicity via the oral, dermal, and inhalation routes (US-EPA, 

2009c). Glyphosate is classified as neither a carcinogen nor a teratogen (US-EPA, 2009c). 

Based on toxicological considerations, the EPA Health Effects Division (HED) determined that 

the main metabolite of glyphosate, AMPA (aminomethylphosphonic acid), should not be 

regulated even though detectable levels occur in foods or feed (US-EPA, 2009c).

2.4.2 Worker Health

Field workers routinely exposed to canola through dermal contact or inhalation are subject to the 

same hazards that are encountered by workers exposed to other crops in similar situations.

All pesticides sold or distributed in the U.S. must be registered by the EPA (US-EPA, 2011a). 

Registration decisions are based on scientific studies that assess the chemical’s potential toxicity 

and environmental impact. To be registered, a pesticide must be able to be used without posing 

unreasonable risks to people or the environment. All pesticides registered prior to November 1, 

1984, such as glyphosate, must also be reregistered to ensure that they meet the current, more 

stringent standards and have a reregistration review every 15 years (US-EPA, 2011a). 

Glyphosate was first registered in the U.S. in 1974; the latest reregistration decision for 

glyphosate was issued in 1993 (US-EPA, 1993b; US-EPA, 2009b; US-EPA, 2009a). It is 

currently under reregistration review, which began in July 2009 and is scheduled for completion 

in 2015 (US-EPA, 2009a). 

The EPA published the Worker Protection Standard (WPS) pursuant to 40 CFR part 170 in 1992 

for the purpose of reducing the risk of pesticide poisonings and injuries among agricultural 

workers and pesticide handlers (US-EPA, 2011j). The WPS offers protections to about 2.5M

agricultural workers who work with pesticides at more than 600,000 agricultural workplaces 

(e.g., farms, forests, nurseries, greenhouses). The WPS contains requirements for pesticide 

safety training, notification of pesticide applications, use of personal protection equipment 

(PPE), restricted entry intervals following pesticide application, decontamination supplies, and 

emergency medical assistance.

Growers are required to use pesticides consistent with the application instructions provided on 

the EPA-approved pesticide labels. For example, pesticide labels specify the appropriate worker 

safety practices that must be followed, including the necessary PPE to be worn by mixers, 

loaders, other applicators and handlers. These label restrictions are legally binding, and are 

enforced by the EPA and the states (FIFRA 7 U.S.C. 136j (a)(2)(G) Unlawful Acts). Therefore, 

glyphosate use on GE canola is expected to be consistent with the EPA-approved labels.

Various formulations of glyphosate contain surfactants such as polyethoxylated tallow amine at a 

level of up to approximately 20 percent (200 g/L). Tallow contains a variety of fatty acids (e.g, 

oleic, palmitic, stearic, myristic, and linoleic acids), as well as smaller amounts of cholesterol, 

5 Category I indicates the highest degree of acute toxicity and Category IV the lowest.

20

 
arachidonic, elaidic, and vaccenic acids. While surfactants are typically classified as “inert” 

components in herbicides, they are not toxicologically inert and in many cases they are found to 

be more toxic than the herbicide itself (USDA-FS, 2003).

Allergies to Brassica pollen in the general population are rare, but a small group of workers who 

are intensively exposed to canola, such as plant breeders, may be at risk of developing an allergy 

to B. napus pollen (Fell et al., 1992).

2.5 Animal Feed

Canola can be grazed by livestock. It can also be made into hay or silage (North-DakotaExtension-Service, 2008), although this is not a common practice. The meal that remains after 

crushing the seeds for oil can also be used as animal feed. Some animals find it less palatable 

than other oil seed crops. The majority of canola meal in the United States is fed to cattle and 

pigs as part of a feed ration. Poultry, aquaculture, and specialty animals can also be fed canola 

meal as a high fiber protein source, but low palatability limits feeding rates (Ash, 2012c).

Similar to the regulatory control for direct consumption of canola under the FFDCA, it is the 

responsibility of feed manufacturers to ensure that the products they market are safe and properly 

labeled. Feed derived from GE canola must comply with all applicable legal and regulatory 

requirements, which are designed to protect human health. To help ensure compliance, a 

voluntary consultation process with FDA may be implemented before GE plants in animal feed 

are released into the market. 

2.6 Socioeconomics

As part of an evaluation of impacts on the human environment, NEPA requires consideration of 

economic and social effects (40 CFR 1508.8), whether direct, indirect, or cumulative. However, 

under CEQ regulations (40 CFR 1508.14), “. . . economic or social effects are not intended by 

themselves to require preparation of an environmental impact statement.”

The following socioeconomic factors are considered in this EA: the interaction of social and 

economic factors that affect agricultural production and products, including farm income and 

employment, crop production expenses, crop value and trade. The main focus of this assessment

is the socioeconomic effect on the crop industry, including production and domestic and 

international trade, and crop producers.

2.6.1 Domestic Canola Production

In the U.S. 2010 growing season, canola was planted on approximately 1.5M acres. Production 

valued at $487M was 1.1M metric tons, which was 1.9% of the 60.6M metric tons produced 

worldwide (Boland and Brester, 2012).

Most U.S. canola production is located in the northern states contiguous with Canada. In 2011, 

North Dakota produced 1.3 billion pounds, with a total value of $297M. Oklahoma has become 

the second largest producer of canola in the U.S. Its 2011 production was valued at $20.5

(USDA-NASS, 2012b). Because it has a favorable profile for making cooking oil, biodiesel and 

feedstock, demand for canola is expected to remain high or increase. This continued strong 

21
demand is expected to promote future increases in canola acreage in the U.S. (Ehrensing, 2008; 

Minnesota Canola Council, 2009/2010). 

Harvested acreage in Oregon (slightly more than 6,000 acres in 2012; (USDA-NASS, 2012c)) is 

small in comparison to that for major canola-producing states (Table 3). However, planting 

canola in certain regions of the state is restricted because of its possible impact on specialty 

growers that produce seed crops for cabbage, broccoli, Brussels sprouts, and other commercially 

important varieties of B. oleracea. The concern is cross-pollination by canola. As a 

countermeasure to protect seed crops, the Oregon Department of Agriculture established a canola 

exclusion zone where growing canola is prohibited. There are also areas where canola can be 

grown, but the size of the field and isolation distances are prescribed. Pinning the location of the 

field on a pinning map may also be required (Oregon-Department-of-Agriculture, 2013).

Table 3: Canola Acreage Planted and Harvested in the U.S.: 2011-2012.

Canola Acreage1 Planted and Harvested in the U.S.: 2011-2012.

State

Area planted Area harvested

 2011 2012 2011 20122

Idaho 

Minnesota

Montana 

North Dakota 

Oklahoma 

Oregon 

Washington

Other States3

United States 

19.0 

29.0 

31.0 

860.0 

100.0 

5.3 

10.5 

16.7 

 1,071.5 

33.0 

60.0 

43.0 

 1,300.0 

 150.0 

 6.5 

17.0 

22.0 

 1,631.5 

18.5 

28.0 

30.5 

 850.0 

85.0 

 4.9 

10.2 

15.9 

 1,043.0 

32.0 

58.0 

42.0 

 1,290.0 

 130.0 

 5.7 

16.5 

18.9 

 1,593.1 

1

Thousands of acres

2

Estimate based on forecast data

3

Other States include Colorado and Kansas

Source: (USDA-NASS, 2012c)

22
The Oregon Department of Agriculture has adopted an administrative rule that allows for some 

canola production within the state. Under the rule, a rapeseed exclusion zone has been 

established in Oregon that encompasses most of the specialty seed production region of the state. 

Canola production is not allowed within the exclusion zone. The administrative rule establishes 

the Willamette Valley protected district, which includes portions of Lane, Linn, Benton, Marion, 

Polk, Clackamas, Yamhill, Washington, Multnomah, and Columbia counties. The protected 

district will have two zones. The first is a fully protected zone of more than 1.9M acres that 

prohibits the growing of canola and contains the highest concentration of specialty seed growers 

in the valley. The second zone of about 1.7M acres, located outside the exclusion zone, allows 

the growing of canola but production is limited to a maximum annual total of 2,500 acres. 

Producers desiring to grow canola are required to apply for a contract with ODA that contains 

specific requirements for managing the crop. The rule also establishes a minimum field size of 

25 acres for canola. In general, ODA’s rule limits how much canola can be grown in the 

Willamette Valley, where it can be grown, and requires significant management practices for 

production by controlling inadvertent spread of canola seed.

2.6.2 Organic Farming 

In the U.S., only products produced using specific methods and certified under the USDA’s 

Agricultural Marketing Service (AMS) National Organic Program (NOP) definition of organic 

farming can be marketed and labeled as “organic” (USDA-AMS, 2010a). Organic certification 

is a process-based certification, not a certification of the end product; the certification process 

specifies and audits the methods and procedures by which the product is produced.

In accordance with NOP, an accredited organic certifying agent conducts an annual review of the 

certified operation’s organic system plan and makes on-site inspections of the certified operation 

and its records. Organic growers must maintain records to show that production and handling 

procedures comply with USDA organic standards. 

The NOP regulations preclude the use of excluded methods. The NOP provides the following 

guidance under 7 CFR Section 205.105:

...to be sold or labeled as “100 percent organic”, “organic” or “made with organic 

(specified ingredients or group(s)),” the product must be produced and handled without 

the use of:...

(a) Synthetic substances and ingredients,...

(e) Excluded methods,...

Excluded methods are then defined at 7 CFR Section 205.2 as:

A variety of methods used to genetically modify organisms or influence their growth and 

development by means that are not possible under natural conditions or processes and are 

not considered compatible with organic production. Such methods include cell fusion, 

microencapsulation and macroencapsulation, and recombinant DNA technology 

(including gene deletion, gene doubling, introducing a foreign gene, and changing the 

positions of genes when achieved by recombinant DNA technology). Such methods do 

not include the use of traditional breeding, conjugation, fermentation, hybridization, in 

vitro fertilization, or tissue culture.

23
Organic farming operations, as described by the NOP, are required to have distinct, defined 

boundaries and buffer zones to prevent unintended contact with excluded methods from 

adjoining land that is not under organic management. Organic production operations must also 

develop and maintain an organic production system plan approved by their accredited certifying 

agent. This plan enables the production operation to achieve and document compliance with the 

National Organic Standards, including the prohibition on the use of excluded methods. (USDAAMS, 2010a). 

Common practices organic growers may use to exclude GE products include planting only 

organic seed, planting earlier or later than neighboring farmers who may be using GE-crops so 

that the crops will flower at different times, and employing adequate isolation distances between 

the organic fields and the fields of neighbors to minimize the chance that pollen will be carried 

between the fields (NCAT, 2003). Although the national organic standards prohibit the use of 

excluded methods, they do not require testing of inputs or products for the presence of excluded 

methods. The presence of a detectable residue of a product of excluded methods alone does not 

necessarily constitute a violation of the national organic standards (USDA-AMS, 2010a). The 

current NOP regulations do not specify an acceptable threshold level for the adventitious 

presence of GE materials in an organic-labeled product. The unintentional presence of the 

products of excluded methods will not affect the status of an organic product or operation when 

the operation has not used excluded methods and has taken reasonable steps to avoid contact 

with the products of excluded methods as detailed in their approved organic system plan (Ronald 

and Fouche, 2006; USDA-AMS, 2010a). 

Organic market and products

The organic sector is rapidly growing both in the United States and the EU. Consumer purchases 

in these two regions made up 95% of estimated world retail sales of organic food products in 

2003 (Dimitri and Oberholtzer, 2005). Annual manufacturer survey results (Organic Trade 

Association, 2011), indicated that estimated U.S. organic food sales for 2010 were $26.7 billion. 

This represented a 7.7 % growth rate from the previous year. The market sector experiencing the 

highest growth rate during 2010 was organic fruits and vegetables, which increased 11.8 % 

compared with 2009 sales. The market share for organic fruits and vegetables was 11% of all 

U.S. fruit and vegetable sales (Organic Trade Association, 2011). Organic products represented 

approximately 4% of total 2010 sales in the food and beverage sector (Organic Trade 

Association, 2011). 

2.6.3 Foreign Trade

U.S. and global trade are greatly affected by the growth and stability of world markets, including 

changes in world population, economic growth, and income. Other factors affecting agricultural 

trade are global supplies and prices, changes in exchange rates, government support for 

agriculture, and trade protection policies. 

U.S. farmers and agricultural firms rely heavily on export markets to sustain prices and revenues

because productivity of U.S. agriculture increases faster than the demand for domestic food and 

fiber. U.S. food imports have increased with the corresponding increase in demand for greater 

diversity in the food supply. U.S. consumers benefit from imports because imports expand food 

24
variety. This also tends to stabilize year-round supplies of and prices for fresh fruits and 

vegetables.

U.S. agricultural exports have been larger than U.S. agricultural imports since 1960, generating a 

surplus in U.S. agricultural trade. USDA, ERS provides research and analysis on factors 

influencing U.S. agricultural exports and imports(USDA-ERS, 2013). Oilseed crops and their 

processed products constitute about 45% of this export market (USDA-ERS, 2012c). 

Canola is a minor U.S. crop. The U.S. exports very little canola and the primary destination of 

that canola is Canadian crushing plants. The U.S. imports canola. Most of that comes from 

Canada to supplement domestic supplies used for crushing. As canola production has expanded 

over the past 20 years, global trade in canola seed and products has also increased. However, 

trade continues to be a smaller share of production than other major oilseeds. Trade in canola 

meal is limited because of the abundance of higher quality soybean meal and the high cost of 

transportation relative to the value of canola meal. Japan, Mexico, China, and the European 

Union (EU) are major importers of canola seed. The United States is the primary importer of 

canola oil and meal because of its proximity to Canada and the ease of cross-border trade

(USDA-ERS, 2012b). 

25
3 ALTERNATIVES

This document analyzes the potential environmental consequences of a determination of 

nonregulated status for an alternative to existing GR canola varieties, Pioneer 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 PPRA (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 are evaluated in this 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.

3.1 No-action Alternative: Continuation as a Regulated Article

Under the No-actionAlternative, APHIS would deny the petition. Pioneer 73496 Canola and 

progeny derived from Pioneer 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 Pioneer 73496 Canola and measures to ensure physical and 

reproductive confinement would continue to be implemented. APHIS could choose this 

alternative if there were insufficient evidence to demonstrate the lack of plant pest risk from the 

unconfined cultivation of Pioneer 73496 Canola. 

However, this alternative is not the Preferred Alternative because APHIS has concluded through 

a PPRA that Pioneer 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. 

3.2 Preferred Alternative: Pioneer 73496 Canola is No Longer a Regulated 

Article

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

regulated articles under the regulations at 7 CFR part 340. Pioneer 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 Pioneer 73496 Canola and progeny 

derived from this event. 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 PPA. Because the agency has 

concluded that Pioneer 73496 Canola is unlikely to pose a plant pest risk, a determination of 

nonregulated status of Pioneer 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.

Under this alternative, growers may have future access to Pioneer 73496 Canola and progeny 

derived from this event, if the developer decides to commercialize Pioneer 73496 Canola. 

26
3.3 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 accordance with the its authority under the plant pest provisions of 

the PPA, and the regulations at 7 CFR part 340. This evaluation considered 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.

3.3.1 Prohibit Any Pioneer 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 Pioneer 73496 Canola, including 

denying any permits associated with the field testing. APHIS determined that this alternative is 

not appropriate because APHIS has concluded that 73496 canola is unlikely to be a plant pest 

risk (USDA-APHIS, 2013).

In enacting the PPA, Congress included findings that directed in Section 402(4) that: “decisions 

affecting imports, exports, and interstate movement of products regulated under this title [i.e., the 

PPA] 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 

established principles consistent with Executive Order 13563 to guide agencies in the 

development and implementation of policies for oversight of emerging technologies such as GE

that included the following guidance:

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

other information, within the boundaries of the authorities and mandates of each agency; . . .” 

Consistent with this guidance and based on the findings and scientific data evaluated for the 

PPRA (USDA-APHIS, 2013), APHIS concluded that 73496 canola is unlikely to pose a plant 

pest risk. Therefore, there is no basis in science for prohibiting the release of 73496 canola. 

3.3.2 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. APHIS has 

concluded that 73496 canola is unlikely to pose a plant pest risk, so there is no regulatory basis 

under the plant pest provisions of the PPA for considering approval of the petition only in part. 

3.3.3 Production/Geographical Restrictions to Isolate 73496 Canola from

Non-GE Canola

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

considered requiring an isolation distance separating 73496 canola from non-GE canola.

However, because APHIS has concluded that 73496 canola is unlikely to pose a plant pest 

27
risk(USDA-APHIS, 2013), an alternative based on requiring isolation distances would be 

inconsistent with the 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 the APHIS plant pest risk assessment 

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 pose a plant pest risk, and will 

not exhibit a greater plant pest risk in any geographically restricted area. Therefore, such an 

alternative would not be consistent with the APHIS statutory authority under the plant pest 

provisions of the PPA and regulations in 7 CFR part 340 and the biotechnology regulatory 

policies of the Coordinated Framework.

Based on the foregoing considerations, the imposition of isolation distances or geographic 

restrictions would not meet the 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. Individuals might choose on their own to 

geographically isolate their non-GE canola 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 American Organization of Seed Certifying Agencies (AOSCA, 

2010).

3.3.4 Requirement of Testing for 73496 Canola

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

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

However, because 73496 canola does not pose a plant pest risk (USDA-APHIS, 2013), testing 

requirements are inconsistent with the plant pest provisions of the PPA, the regulations at 7 CFR 

part 340 and the biotechnology regulatory policies of the Coordinated Framework. Therefore, 

for 73496 canola such requirements would be inconsistent with the APHIS purpose and need to 

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

3.3.5 Comparison of Alternatives 

Table 4 presents a summary of the potential impacts associated with selection of either of the 

alternatives evaluated in this EA. The impact assessment is presented in Section 4 of this EA.

28
Table 4: Summary of Issues of Potential Impacts and Consequences of Alternatives.

Summary of Issues of Potential Impacts and Consequences of Alternatives.

Attribute/Measure Alternative A:No Action

Alternative B: 

Determination of 

Nonregulated Status

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 

No change from Alternative 

A

29
Summary of Issues of Potential Impacts and Consequences of Alternatives.

Attribute/Measure Alternative A:No Action

Alternative B: 

Determination of 

Nonregulated Status

growers use a two-year rotation 

of canola and wheat. 

Canola Seed Production Most seed production is in

Alberta. In the U.S seed 

production occurs in the

Columbia Basin in eastern

Washington, 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 the NoAction Alternative

Pesticide Use EPA-approves uses of 

herbicides on canola. 

Herbicides are specifically 

labeled to allow their use on HR 

canola. 

No change from the Noaction Alternative

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 

No change from No-action

Alternative

30
Summary of Issues of Potential Impacts and Consequences of Alternatives.

Attribute/Measure Alternative A:No Action

Alternative B: 

Determination of 

Nonregulated Status

quality by reducing erosion. 

Growers currently use best 

management practices to 

address their specific needs in 

producing canola.

Water Resources

The most significant source of 

non-point source pollution is 

increased sedimentation from 

soil erosion, which can 

introduce sediments, fertilizers, 

and pesticides to 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.

No change from No-action

Alternative

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

31
Summary of Issues of Potential Impacts and Consequences of Alternatives.

Attribute/Measure Alternative A:No Action

Alternative B: 

Determination of 

Nonregulated Status

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 compete with growing 

canola 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.

No change from No-action

Alternative

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 

No change from No-action

Alternative

32
Summary of Issues of Potential Impacts and Consequences of Alternatives.

Attribute/Measure Alternative A:No Action

Alternative B: 

Determination of 

Nonregulated Status

communities that have adverse 

effects on plants grown in those 

soils.

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 a minor crop 

produced on approximately 

0.04% of the harvested 

cropland in the U.S. Current

trends influencing the acreage of 

canola planted annually are driven

by market 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 

No change from No-action 

Alternative

33
Summary of Issues of Potential Impacts and Consequences of Alternatives.

Attribute/Measure Alternative A:No Action

Alternative B: 

Determination of 

Nonregulated Status

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 those that 

might arise from the GAT 

protein are removed during 

filtration. Workers that 

routinely handle glyphosate, 

may be exposed 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 Farm income is positively

impacted by currently available No change from No-action 

34
Summary of Issues of Potential Impacts and Consequences of Alternatives.

Attribute/Measure Alternative A:No Action

Alternative B: 

Determination of 

Nonregulated Status

Environment HR canola by reducing

production costs or increasing

revenues. GR canola generally

has a positive impact on farm

income due to cost savings from

reduced fuel and pesticide use.

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 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.

No change from No-action 

Alternative

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

35
Summary of Issues of Potential Impacts and Consequences of Alternatives.

Attribute/Measure Alternative A:No Action

Alternative B: 

Determination of 

Nonregulated Status

CWA, CAA, EOs Fully compliant

No change from No-action

Alternative:

36
4 ENVIRONMENTAL CONSEQUENCES

This analysis of potential consequences addresses the possible impact to the environment from 

the alternatives analyzed in this EA for 73496 canola (i.e., no action or approving the petition for 

nonregulated status). These are described in detail throughout this section.

4.1 Scope of Analysis

For the purposes of this analysis, an impact was defined as any change (positive or negative) that 

alters the affected environment (described for each resource area in Section 2.0). Impacts may 

be categorized as direct, indirect, or cumulative. A direct impact is an effect that results solely 

from a proposed action without intermediate steps or processes. Examples include soil 

disturbance, air emissions, and water use. An indirect impact may be an effect that is related to 

but removed from a proposed action by an intermediate step or process. Examples include 

surface water quality changes resulting from soil erosion caused by increased tillage, and 

changes in worker safety impacts resulting from changes in herbicide use practices. 

A cumulative effects analysis is also included for each environmental issue. A cumulative impact 

may be an effect on the environment which results from the incremental impact of the proposed 

action, when added to other past, present, and possible future actions. If there are no direct or 

indirect impacts identified for a resource area, then there are no cumulative impacts. Cumulative 

impacts are discussed in Section 5.

When it is not possible to quantify impacts, APHIS provides a qualitative assessment of potential 

impacts. Some impacts of this product and its cultivation will not differ between the alternatives. 

Although the preferred alternative would allow for new plantings of 73496 canola anywhere in 

the U.S., APHIS will limit the environmental analysis to those areas that currently support canola

production. To determine areas of canola production, APHIS used national agriculture statistics 

data (USDA-NASS, 2013) to identify the areas in which canola is grown.

4.2 Acreage and Area of Canola Production

No-action Alternative: Acreage and Area of Canola Production

Winter canola requiring vernalization is generally produced in the Pacific Northwest, southern

Great Plains, and Midwest regions of the U.S. Winter canola not requiring vernalization is

produced in the southeast region of the U.S. Spring canola is grown primarily in the northern

Great Plains states including North Dakota, South Dakota, Minnesota, Montana, Idaho, and also

in Washington. Winter and spring canola varieties may require different agronomic practices

and can be affected by different insect pests and diseases. Growers consider climate as well as 

other factors when choosing which canola to plant (Brown et al., 2008). In a few areas, either

crop may be grown. Winter canola has a higher yield potential than spring canola (Boyles et 

al., 2009), but can only be grown in areas with relatively mild winters.

According to the 2007 Census of agriculture, growers in 28 U.S. states planted canola. However, 

in 12 of these states, so few growers produced canola that NASS cannot report the data without 

violating the privacy of the individual growers, which is why these regions do not appear on the 

map in Figure 1. Of the remaining 16 states, five states (Texas, Pennsylvania, Michigan, 

37
Nebraska, and California) each harvested less than 500 acres of canola. North Dakota produced

about 93% of all the canola grown in the U.S.

In 2011, North Dakota farmers planted 840,000 acres of canola, and there were 1.4M acres of the 

crop planted in 2012 in ND. Canola acreage in the U.S. for all purposes in 2012 was estimated

to be 1.7M acres (Table 3). This is an increase of 0.7M acres from the previous year (USDANASS, 2012c).

Fluctuations in the geographic locations of production and total canola acreage are influenced by 

price, net return relative to other crops, and the availability of suitable varieties for the growing 

region. The overall demand for canola oil has increased since the 1980s. However the acreage 

dedicated to canola production in the U.S. does not meet the U.S. demand for canola oil (Figure 

3).

Figure 3: U.S. Canola Oil Production 1987-2009. 

Production increased during the past two decades, but remains behind U.S. demand.

By 2006, nearly all of the U.S. canola was HR (Johnson et al., 2007). Commercially available 

canola varieties that are resistant to one of three different herbicides include: glyphosate, 

glufosinate and imidazolinone. The glyphosate- and glufosinate-resistant varieties were created 

using genetic engineering. Those resistant to imidazolinone were created using mutagenesis. In 

2008, GE (glyphosate and glufosinate) HR-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. canola38
growing state of North Dakota was derived from HR-canola varieties, with GR varieties grown 

on 57% of that acreage. Glufosinate resistant varieties were grown on 37% of the ND acreage

and imidazolinone-resistant varieties were grown on 5% of the acreage in ND (Johnson et al., 

2007). In Minnesota, 78% of the acreage was planted in HR-canola varieties: 50% GR, 25% 

glufosinate-resistant, and 3% imidazolinone resistant varieties (Johnson et al., 2007). A similar 

pattern for HR varieties adopted for planting in Canada has developed during the past two 

decades (Figure 4).

Figure 4: Changes in Adoption of HR-Canola Varieties by Canadian Growers Since 1995.

Source: Canola Council of Canada, 2010a

Preferred Alternative: Acreage and Area of Canola Production

Approving the petition for nonregulated status is not likely to have any influence on the number 

of acres planted to canola in the U.S. As described in the No-action alternative, the U.S. does 

not produce enough canola to meet the domestic demand for canola oil (Figure 3). Canola 

acreage is influenced by the demand for vegetable oil, the price of canola, and the price of other 

potential crops that could be planted on those same acres. 

Glyphosate-resistant varieties are available for both winter and spring canola (Winfield, 2013). 

The approval of the petition for nonregulated status will not alter availability of currently 

marketed HR varieties. It may offer new choices in the marketplace if this trait is bred into 

commercial varieties that do not currently offer glyphosate resistance. Growers choose varieties 

by considering a number of characteristics, including disease resistance and resistance to a 

particular herbicide. It is likely that canola acreage in the U.S. will continue to be planted 

predominantly with HR varieties and the percent acres planted in glyphosate and glufosinate 

resistant varieties will likely remain the same based on trends in the Canadian industry, see 

Figure 4.

4.2.1 Agricultural Production of Canola

No Acton Alternative: Agricultural Production of Canola

39
Cropping Practices. Spring canola requires an average of 100-125 days from seeding to 

harvesting. Canola grows best in a temperature range of 54°-86°F (12-30oC), with the optimal 

temperature for maximum growth and development being 68°F (20oC) (Brown et al., 2008).

Spring canola is usually planted in March and harvested in September or October. In the U.S., 

most is grown in North Dakota (92% of production acreage), Minnesota, and the Pacific 

Northwest (i.e., Idaho, Washington, and Montana) because optimal crop production occurs under 

a cool temperature regime.

Winter canola is planted in the Pacific Northwest, Midwest, and Great Plains, but requires 

vernalization (prolonged exposure to low temperatures) to flower, so it has to overwinter. 

Winter canola that is planted in the southeast region of the U.S. also overwinters, but does not 

require vernalization (Brown et al., 2008). Winter canola is typically planted in September and 

harvested in June or July. It is grown on fewer acres than spring canola, but can be grown in a 

broader range of environments if winters are mild.

The types of tillage utilized by growers include conservation tillage (no-till, ridge-till and mulchtill), reduced tillage, and intensive (i.e., conventional) tillage. Conventional tillage is associated 

with intensive plowing and less than 15% crop residue at the soil surface. Reduced tillage is 

associated with 15-30% crop residue. Conservation tillage, including no-till practices, is 

associated with at least 30% crop residue and substantially less soil erosion than other tillage 

methods (Sandretto and Payne, 2006). While tillage can increase soil erosion, which leads to 

reduced soil fertility and degraded water resources, it is an integral part of weed management 

(Duke and Powles, 2009).

Conventional tillage is used for controlling weeds, reducing populations of overwintering 

insects, and controlling fungal outbreaks (MacRae et al., 2000; Brown et al., 2008; Duke and 

Powles, 2009). It is most important for early seeding operations; it improves seed to soil contact 

and promotes rapid seedling development by warming the soil (Brown et al., 2008; Smyth et al., 

2010). Drawbacks to conventional tillage include soil moisture loss, increased soil compaction, 

loss of soil organic matter and increased vulnerability to wind and water erosion (Brown et al., 

2008).

Survey information on tillage practices for Canada is described below. Similar survey 

information for the U.S. is incomplete. Nearly all canola production in Canada is situated in the 

western prairie provinces (Figure 1). Canola production practices used there (Smyth et al., 2010)

are similar to methods used in states such as North Dakota, where most of the U.S. canola 

production occurs. Therefore, the Canadian survey offers a comparable basis for analysis. 

These data indicated that for weed control, 77% of canola growers relied exclusively on 

herbicides, 28% used a combination of herbicide treatments and tillage, and 7% used only tillage

(Smyth et al., 2010).

Use of tillage has dropped considerably since 2000, when 89% of the growers reported using 

tillage as a form of weed control. Approximately a five-fold increase in reliance on no-till or 

minimum till practices among western Canadian growers of herbicide-resistant canola was 

observed between 1999 and 2006 (Smyth et al., 2010), a trend that is clearly correlated with 

increased adoption of HR canola; (Duke and Powles, 2009; Smyth et al., 2010).

Despite the increasing flexibility in the ability to apply herbicides to control weeds, conventional 

tillage continues to be used on some farms where HR canola is cultivated. This is most likely 

attributable to the cost of tillage, which is less expensive than herbicide control (Smyth et al., 

40
2010). In some areas of the U.S., individual growers confronted by GR weeds recently resorted 

to tillage to achieve adequate control (Duke and Powles, 2009). In general, GE crops have 

reduced tillage from 89% to 35%, but as this report shows, in some individual instances, tillage 

is useful in managing herbicide-resistant weeds.

Rotational Practices. Crop rotation aids in the management of diseases, insects, and weeds and 

increases organic matter and soil fertility. It is recommended that spring canola follow cereal 

grains or fallow land in a rotation (Berglund et al., 2007), while winter canola is generally 

planted once every 2-3 years in a crop rotation with winter wheat (Schoonover, 2010). 

Successive planting of canola at the same location is not recommended because of increased risk 

from soil-borne fungal diseases such as Alternaria, blackleg, clubroot, and Sclerotinia (NDSU, 

2005; Brown et al., 2008). Canola is also not recommended after pea, lentil, chickpea, soybean, 

sunflowers, and field, or dry bean crops because they also the increase risk of soil-borne diseases 

such as Sclerotinia, Rhizoctonia, and Fusarium root rots (Brown et al., 2008).

In the northern U.S., approximately half of growers typically rely on a three-year rotation that 

includes canola, a small grain (generally wheat) and soybean. The remaining growers generally 

use a two-year rotation of canola and wheat. Canola is rarely rotated with corn.

Sclerotinia stem rot (Sclerotinia sclerotiorum) is a serious disease of canola that occurs 

worldwide (Luper et al., 2007). It caused an average state-wide yield loss of 13% in North 

Dakota and Minnesota from 1998-2007 with some fields suffering a 50% loss (Markell et al., 

2009). Once the disease is established, the most important control is rotation with nonsusceptible crops.

Blackleg disease (Leptosphaeria maculans/biglobosa) is also found worldwide. In North 

Dakota, it has reportedly caused yield losses surpassing 50% (Markell et al., 2008). Important 

control methods are rotation and disease-free, fungicide-treated seed (Boyles et al., 2009).

Alternaria black spot is also found in all canola growing areas in the U.S. It tends to be a more 

prevalent problem in wetter years. Yield losses up to 20% or more have been reported if there is 

pod shatter (Brown et al., 2008). Control methods for Alternaria include rotation, sowing clean, 

disease-free seed, and controlling weeds. Clubroot is found in some areas with varying severity 

in the U.S. (MAFRI). In Quebec, heavily infested areas reportedly suffered a yield loss of 90% 

(Mendoza, 2009). Chemical control methods are not available for clubroot, so rotation with a 

non-brassacaceous crop is the only management alternative (MAFRI). Information about canola 

rotation with other crops that share diseases for the Great Plains can be found in Table 5.

Rotations are also used to help control weed populations that directly impact crop yields, and 

serve as reservoirs for pathogens (MacRae et al., 2000; NDSU, 2005). Many broad-leaf weeds, 

including wild mustard, pigweed, lambsquarters, marshelder, Canada thistle, and burdock are 

hosts of Sclerotinia, so it is critical to control these weed populations between rotations (NDSU, 

2005). Preceding or following a canola planting in a rotation with another crop for which a 

different herbicide is used (e.g, a cereal rotation prior to planting canola to control broadleaf or 

perennial weeds) helps keep problematic weed populations low for the canola planting (NDSU, 

2005). Rotation of crops often allows for different herbicide control options depending on the 

herbicide-resistance traits available in that crop.

41
Table 5: Guide to Timing of Canola Rotation Crops

Guide to Timing of Canola Rotation Crops

Crop

Number of Years

Suggested Between Canola

and Alternate Crop

Comments

Wheat

Oats

Barley

0

No diseases in common. Can be grown the 

year before or after canola. Herbicide 

residue carryover can be a problem.

Corn

Sorghum

0/1

No diseases in common. Zero years where 

herbicide residue is not a concern and one 

year where atrazine is used on corn.

Potatoes

Clover

Field 

beans

Cotton

1 Common diseases are Rhizoctonia and 

Fusarium root rots.

Alfalfa

Soybean

s

2 Common diseases are Rhizoctonia and 

Fusarium root rots and Sclerotinia stem rot.

Sunflow

ers

3 Common diseases are Rhizoctonia and 

Fusarium root rots and Sclerotinia stem rot.

Source: Boyles et al., 2007

Injury to canola can be caused by herbicide residue. For example, this may result from treatment 

of a different crop previously planted at the same location as the canola crop. Some instances of 

persistent herbicide residue that required a 40-month interval before growing canola without risk 

of injury have been reported (NDSU, 2005; Brown et al., 2008). Therefore, the use of some 

herbicides on some crops can impose restrictions on the crop rotation systems that can be used at 

a given site. One advantage of GR crops is that glyphosate does not produce residue that must 

be managed with plant-back restrictions (Table 6). Therefore, GR canola is beneficial as a crop 

that broadens crop rotation options.

Canola produces glucosinolates in non-seed parts of the plant. These compounds are degraded in 

soil into products that are toxic to some species of insects, nematodes an fungi (Brown et al., 

2008).

42
The tap-root structure of canola plants promotes translocation of nutrients within the plant. This 

is significant because it contributes to the release of nitrogen transported from deeper in the soil 

by post-harvest plant residue. It also increases the organic content of the soil for subsequent 

crops (Brown et al., 2008). Because canola is well adapted to regions where small grains are 

grown, it also provides growers with more options for other crops. This increases the potential 

for diversity of farm production and the reduction of market risks (Brown et al., 2008). GE 

canola has the same benefits as non-GE canola with respect to crop rotation.

Insecticide, Fungicide, and Fertilizer Use. Low soil fertility levels have a very serious impact on 

yield in canola production (Berglund et al., 2007). Nitrogen, phosphorous, potassium, and sulfur 

are applied in the spring before planting at application rates similar to those for small grain crops 

(NDSU, 2005; USDA-ERS, 2010). Sulfur requirements for canola are generally higher than for 

other crops and nitrogen is often limiting for the cultivation of winter canola (NDSU, 2005; 

Brown et al., 2008; USDA-ERS, 2010).

Although some insect pests infest one type more than the other, spring and winter canola are 

impacted by the same species complex (Brown et al., 2008), so similar insecticide regimes can 

be used for both canola types. Insecticide products containing bifenthrin, deltamethrin, 

gammacyhalothrin, lambda cyhalothrin, and methyl parathion as active ingredients are currently 

registered for canola in the U.S. (Brown et al., 2008). Seed treatments (with or without 

fungicides) are also registered for canola (Table 7). Cost-effective control of fungal diseases is 

usually achieved by using seed treatments that combine an insecticide and fungicide (Brown et 

al., 2008). Foliar fungicides are costly and used only in situations of extreme disease pressure or 

wet weather. Foliar fungicides include Endura and Ronilan EG for control of Sclerotinia and 

Quadris for blackleg (Brown et al., 2008). Planting disease-free certified seed and crop rotation 

are generally the most effective and economic means of controlling fungal diseases in canola

(Boyles et al., 2009).

General Weed management. Growers control weeds because they reduce crop yield and quality 

by competition for water, nutrients, and sunlight. Decisions about weed management are among 

the most complex ones that growers must make because all options have advantages and 

disadvantages. Growers must manage simultaneously a wide array of broadleaf and grass weeds. 

In selecting a weed management strategy, growers choose the most economical means to control 

weeds that do not decrease the quality or quantity of the crop. Growers will often use a 

combination of weed management techniques including application of different herbicides to 

effectively control weeds in their fields. The strategy depends on the types of weeds, the level of 

infestation, the cropping system, the type of soil, cost, weather, time, and labor.

Once established, canola competes well with most weeds. Early weed control is critical 

however, because canola does not compete well with many weeds in its earliest developmental 

stages (NDSU, 2005; Harker et al., 2008). Studies of various HR varieties have shown that early 

herbicide application, before the 3- to 6-leaf stage, promotes yields (Martin et al., 2001; Harker 

et al., 2008).

As noted previously, another strategy to suppress weeds is crop selection in a rotation. For 

example, a wheat rotation prior to canola planting effectively manages Canada thistle because 

selective broadleaf herbicides that control perennial weeds can be applied to wheat (NDSU, 

2005). One example is winter canola production in Oklahoma, where the crop is commonly 

43
rotated with wheat, sorghum, and corn to manage the problem weed complex of downy brome 

and Italian ryegrass (Luper et al., 2007).

Table 6: Herbicide Plant-back Restrictions for Canola

Herbicide Common Name Plant Back Restriction on Herbicide Label

Tralkoxydim 106 days

Carfentrazone None

Metsulfuron 10 or 22 months

Triasulfuron 4 months

Imazamethabenz 15 months

Quizalofop None

Atrazine 18 months

Difenzoquat Next season

Pinoxaden 120 days

Flufenacet + Metributzin 12 months

Bentazon None

Imazamox 26 months

Bromoxynil 30 days

Dicamba 120 days

Aminopyralid + Fluroxypyr 9 months

Clodinafop 30 days

Metolachlor None

Pyraflufen 30 days

Flucarbazone 9 months

44
Herbicide Common Name Plant Back Restriction on Herbicide Label

Tribenuron 60 days

Triallate 12 months

Chlorsulfuron 14-18 months

Chlorsulfuron None

Paraquat None

Thifensulfuron 45 days

Thifensulfuron 60 days

Diclofop None

Pyrasulfotole + Bromoxynil 9 months

Diuron 12 months

Glufosinate 120 days

Linuron 12 months

Sulfosulfuron 22 months

MCPA 3 months

Propoxycarbazone 22 months

Propoxycarbazone + Mesosulfuron 12 months

Florasulam + MCPA 9 months

Mesosulfuron 10 months

Dimethenamid None

Quinclurac 10 months

Prosulfuron 10 months

45
Herbicide Common Name Plant Back Restriction on Herbicide Label

Sethoxydim None

Pyroxulam 9 months

Pendimethalin Next season

Fenoxyprop None

Imazethapyr 40 months plus bioassay

Glyphosate None

Clethodim None

Metribuxin 12 months

Ethalfluralin None

Sulfentrazone 24 months

Fluroxypyr 120 days

Clopyralid None

Quinclurac 10 months

MCPB None

Picloram 36 months or field bioassay

Trifluralin None

2, 4-D 3 months

Based on (Brown et al., 2008)

46
Table 7: Seed Treatments Registered for Use on Canola

Seed Treatment Comments

Gaucho 600

(imidacloprid)

Provides seedling protection from aphids, 

flea beetles and wireworms when 

commercially applied.

Prosper 400

Contains a systemic chloronicotinyl 

insecticide (clothianidin) for flea beetle 

control, and three fungicides (thiram, 

carboxin, and metalaxyl) to help protect 

canola seedlings from seed rot damping 

off, seedling blight, and early season root 

rot caused by Pythium, Rhizoctonia, 

Fusarium and seed-borne Alternaria spp 

and blackleg.

Cruiser

(thiamethoxam)

Systemic insecticide which belongs to a 

new subclass of neonicotinoids. Protects 

plants from a broad spectrum of seed, soil 

and foliar chewing and sucking insects.

Helix Xtra

Contains three fungicides 

(difenoconazole, mefenoxam and 

fludioxinil) and an insecticide

(thiamethoxam), to protect canola seed 

against seed- and soil-borne diseases as 

well as flea beetles. Provides broadspectrum protection against diseases such 

as seed rot, damping off, seedling blight, 

root rot and seed-borne blackleg.

Helix Lite

Contains three fungicides 

(defenoconazole, mefenoxam and 

fludioxinil) to protect canola seed against 

seed- and soil-borne diseases such as seed 

rot, damping off, seedling blight, root rot

and seed-borne blackleg. Contains half 

the amount of thiamethoxam as Helix 

Xtra and is used for wireworm protection 

and where flea beetle pressure is low.

47
Source: (Brown et al., 2008)

Use of Herbicide-Resistant Canola. There are three different types of HR-canola varieties 

currently available in the U.S. (Brown et al., 2008):

• conventionally derived imidazolinone-resistant (Clearfield);

• GE glyphosate-resistant (Roundup Ready);

• GE glufosinate-resistant (InVigor).

Most GE crops are insect resistant and/or HR. They were introduced commercially in 1996 

(USDA-ERS, 2011). GE crops were quickly adopted because they provided growers with highly 

profitable short-term return on investment compared with conventional varieties (Scandizzo and 

Savastano, 2010). GE crops allow for production methods that are simpler and more flexible, so 

growers are able to reduce management time. This allows a single grower to increase income by 

expanding the crop acreage managed or performing non-farm work (Fernandez-Cornejo and 

Caswell, 2006). Growers also benefit from lower expenses attributable to a reduction in the need 

for pesticide applications. Collateral advantages include more opportunity to implement 

conservation practices and an overall reduction in environmental impacts of the crop production 

system.

Overuse of glyphosate has resulted in a negative impact because it has promoted the 

development of resistant weeds in some field crops in the U.S. Growers with glyphosateresistant weeds in their fields may need to adopt alternative practices to help control glyphosateresistant populations (Duke and Powles, 2009). U.S. consumer concerns regarding GE crops

have been widespread, but they have not been reflected in the marketplace (Fernandez-Cornejo 

and Caswell, 2006).

In 2010, Barfoot and Brookes analyzed how farmers were adopting transgenic crop varieties 

globally. Factors influencing adoption of HR and insect-resistant crops included:

• Ease of use associated with broad-spectrum, post-emergent herbicides and the increased

timeframe available to make spray applications;

• Reduction in damage to crops arising from the application of post-emergent herbicides;

• Ability to use alternative production technologies such as reduced or no-tillage practices;

• Time and fuel savings from the adoption of reduced/no-tillage and other agronomic 

practices as compared with those used in conventional cropping systems;

• Ease of weed control that promotes cleaner crops that reduce harvesting time and overall 

costs of harvesting, and result in higher product quality and value;

• Avoidance of potential damage from soil-incorporated residual herbicides in follow-on 

crops;

• Improved quality of family life arising from social benefits derived from time savings 

made from crop husbandry practices.

Since the commercial introduction of GR canola in 1999, production has fluctuated between 0.8-

1.6M acres (Table 1). The stability of this range is indicated by the highest acreage years (1.6M)

in 2000 and again recently in 2010. As described earlier, planting of HR varieties has increased 

significantly from 1999 to 2006 in the primary U.S production state of North Dakota (25% to 

99% from 1999 to 2006; Johnson et al., 2007), but this was likely attributable to increased 

demand for canola-based products rather than availability of HR varieties. There is no indication 

that the introduction of GR varieties in 1999 significantly changed cultivation acreage of canola 

48
in the U.S. Furthermore, the planting of HR varieties is at or close to the maximum possible in 

the primary states of production (99% in North Dakota in 2006; 78% in Minnesota in 2006; 

Johnson et al., 2007), which is similar to the trend in Canada (99% of Canadian canola acreage is 

planted in HR varieties (Figure 4)). Therefore, the introduction of additional HR varieties, such 

as 73496 canola, would not be expected to increase acreage and would likely be only a 

replacement for other HR varieties already being planted. The introduction of another GR

variety to the marketplace would provide a market alternative and would not be expected to 

significantly change current canola acreage in the U.S.

As previously described, adoption of HR varieties is also high in Canada (Figure 4). 

Commercial adoption of HR canola varieties in Canada has increased steadily since 1996, so that 

by 2010, 99% of Canada’s 16.1M acres of canola were planted to either GE or non-GE HR

varieties (Figure 4). Approximately 47% of Canada’s HR canola acres were planted with GR

Roundup Ready® varieties, 46% were planted with glufosinate-resistant InVigor® varieties

(LibertyLink), and 6% were planted with imidazolinone-resistant Clearfield® varieties. (Smyth 

et al., 2011) used this information to conclude that “adoption rates like this demonstrate that 

producers are recognizing a substantial economic and environmental benefit from HR canola” 

over non-HR varieties. 

Pioneer has analyzed the long-term market for HR canola and expects glyphosate and 

glufosinate-tolerant canola to remain popular with producers (Figure 5). Pioneer does not expect 

producers to plant significant acreages of canola varieties with stacked resistance to glyphosate 

and glufosinate because of concerns about the need to control volunteer canola in crops rotated 

with canola. Inadequate weed control with imidazolinone-resistant canola is expected to limit 

demand for those varieties.

Figure 5: Ten-year Projection of Herbicide-resistant Canola Market Growth in the U.S. and 

Canada. 

Chart shows the projected percent adoption rate of glyphosate, glufosinate, 

Source: Pioneer Hi-Bred Marketing

Herbicide Use and Weed Resistance. Compared to major crops such as corn, soybeans, and 

wheat, there are fewer herbicides available to canola growers. Currently registered herbicides 

for traditional canola and HR canola are listed in Tables 9 and 10.

0

20

40

60

80

100

RR/LL

CL

LL

RR

49
Table 8: Registered Herbicides Commonly Used on Canola in the U.S.

Herbicide Application 

Method Weeds Controlled

Assure II 

(quizalofop) Foliar spray Annual grasses and quackgrass

Poast (sethoxydim) Foliar spray Annual grasses

Select (clethodim) Foliar spray Annual grasses

Sonalan 

(ethalfluralin)

Preplant 

incorporated Several annual broadleafs, foxtail, barnyard grass

Stinger (clopyralid) Foliar spray

Canada thistle, perennial sowthistle, dandelion, 

curly

dock, wild buck wheat, cocklebur, prickly lettuce,

ragweed, chamomile, nightshade, and biennial

wormwood

Treflan (trifluralin) Preplant 

incorporated Several annual broadleafs, foxtail, barnyard grass

Source: Pioneer ER

Table 9: Registered Herbicides for Herbicide-resistant Canola

Herbicide Application

 Method Weeds Controlled

Ignite (glufosinate) for

InVigor varieties Foliar spray Annual broadleafs, annual grasses, whenapplied to early stages

Roundup (glyphosate)

for RoundupReady varieties Foliar spray Most annual broadleafs and grasses

Beyond (imidazolinone)

for Clearfield varieties

Foliar Many annual broadleafs and grasses

50
Crop pests respond to the repeated use of control tactics by evolving biological mechanisms to 

escape control. The first documented case of a weed developing resistance to an herbicide 

occurred in the mid-1960s (Ryan, 1970). During the 1970s, growers in North America and 

Europe began to recognize that one class of herbicides (triazines) that had successfully controlled 

many different weeds was no longer effective against certain populations of as many as 30 

different weed species (Bandeen et al., 1982; LeBaron and McFarland, 1990). By 1990, weed 

scientists had evidence that at least 99 weed species contained individuals (biotypes) that had 

evolved resistance to one or more herbicides (Holt and LeBaron, 1990). Currently, more than 

365 biotypes of herbicide-resistant weeds occur around the world (Weedscience.org, 2011). For 

additional information about the evolution of herbicide-resistant weeds and stewardship of HR 

canola see Appendix 9 of the petition (Pioneer, 2011).

Only two glyphosate-resistant weed species (common ragweed and kochia) are found in canola 

weed surveys in North Dakota (Table 2). All glyphosate-resistant weed species, except for Poa 

annua (annual bluegrass), are found in states reporting some canola crop acreage in 2007 (See 

Table 10).

Weeds with multiple herbicide resistance (glyphosate resistance plus resistance to at least one 

other herbicide class) have been reported in several states. A summary follows:

• glyphosate- and bipyridilium-resistant hairy fleabane in California;

• glyphosate- and ALS-resistant Palmer amaranth in Georgia and Mississippi;

• glyphosate- and ALS-resistant common waterhemp in Illinois;

• glyphosate- and ALS-resistant giant ragweed in Minnesota and Ohio;

• glyphosate-, PPO-inhibitor- and ALS-resistant common waterhemp in Missouri;

• glyphosate- and ALS-resistant common ragweed and horseweed in Ohio;

• glyphosate- and glutamine synthase inhibitor-resistant Italian ryegrass in Oregon.

Survey information on tillage practices for Canada follows. Similar survey information for the 

U.S. is limited or incomplete. The practices in western provinces, where nearly all Canadian 

canola is produced (Smyth et al., 2010) are virtually identical to U.S. cultivation methods in 

North Dakota, where most of the U.S. canola acreage is located (Table 3). Based on the western 

Canada survey, in HR canola production, conventional tillage has become less expensive over 

the years from 1999 to 2006 and was estimated to be cheaper than herbicide weed control 

options (Smyth et al., 2010). When growers were asked about their weed control measures, 77% 

reported they use herbicides only, 28% said they use herbicides and tillage, and 7% said they 

used tillage only.

Use of tillage has declined considerably since 2000, when 89% of canola growers reported using 

this method of weed control. This is attributed to better weed control options that are possible 

with HR canola. Approximately a five-fold increase in the use of no-till practices among 

western Canadian growers of HR canola was observed between 1999 and 2006 (Smyth et al., 

2010). This increase in the use of no-till or minimum-till practices is correlated with increased 

adoption of HR canola (Duke and Powles, 2009; Smyth et al., 2010).

51
Despite this ability to broadly apply herbicides to control weeds, cultivation tillage continues to 

be used on some farms cultivating HR canola. This is probably an effect of the lower cost of 

using tillage as compared with herbicide control (Smyth et al., 2010). Recently, in some areas of 

the U.S., individual growers with GR weeds have resorted to tillage to control glyphosateresistant populations (Duke and Powles, 2009). In general, GE crops have reduced tillage from 

89% to 35%, but in some instances tillage is necessary for effective control of HR weeds.

GE canola seeds average 30-40% more expensive than those for conventional varieties 

(Zollinger et al., 2008). summarizes recent acreage data (2008) for HR canola varieties grown in 

North Dakota (Zollinger et al., 2008) including those that are GE.

Preferred Alternative: Agricultural Production of Canola

Approving the petition for nonregulated status would not change the effects of canola farming on 

agronomic practices. Based on past trends in HR canola adoption (see figure 4) and future 

predictions for HR canola adoption (see figure 5) 73496 canola, another GR-canola option 

similar to other nonregulated canola cultivars, would likely only replace other GR varieties. 

Because the majority of canola production is currently reliant on herbicide-resistant canola

varieties and canola production is not expected to increase, the introduction of an additional GR 

variety will have no effect on the production practices currently employed in canola. As 

described in the No-action Alternative, agricultural practices are influenced by disease pressures, 

insect pressures, and weed pressures.

Table 10: Herbicide Resistant Weeds of 25 Canola Producing States

Species Common Name Resistant To One Or More Mode Of Action

Palmer Amaranth Glycines

Italian Ryegrass ACCase inhibitors, ALS inhibitors, Hlycines, Glycines ,

Glutamine synthase inhibitors, Chloroacetamides and others

Johnson grass Glycines

Hairy Fleabane Bipyridiliums and Glycines

Smooth Crabgrass Synthetic Auxins

Junglerice Glycines

Barnyardgrass ACCase inhibitors, Thiocarbamates and others, Synthetic

Auxins, Ureas and amides

Late Watergrass ACCase inhibitors, Thiocarbamates and others

52
Rigid Ryegrass Glycines

Kochia Photosystem II inhibitors, ALS inhibitors, Synthetic Auxins,

Glycines

Wild Oat ACCase inhibitors, Thiocarbamates, others, and Unknown

Common Waterhemp ALS inhibitors, Photosystem II inhibitors , Glycines

PPO inhibitors, 4-HPPD inhibitors, ALS inhibitors

Field Bindweed Synthetic Auxins

Powell Amaranth Photosystem II inhibitors , Ureas and amides

Redroot Pigweed Photosystem II inhibitors , Ureas and amides

Horseweed Glycines, Photosystem II inhibitors , Bipyridiliums, ALS

inhibitors, Ureas and amides

Wild Carrot Synthetic Auxins

Common Purslane Photosystem II inhibitors , Ureas and amides

Spiny Amaranth Glycines

Goosegrass Glycines, Dinitroanilines and others

Annual Bluegrass Glycines

Common Ragweed ALS inhibitors , Glycines, PPO inhibitors

Giant Ragweed ALS inhibitors ,Glycines

Yellow Starthistle Synthetic Auxins

4.2.2 Organic Canola Production

No-actionAlternative: Organic Canola Production

It is important to note that the current NOP regulations do not specify an acceptable threshold 

level for the adventitious presence of GE materials in an organic-labeled product. The 

unintentional presence of the products of excluded methods will not affect the status of an 

organic product or operation when the operation has not used excluded methods and has taken 

reasonable steps to avoid contact with the products of excluded methods as detailed in their 

approved organic system plan (Ronald and Fouche, 2006; USDA-AMS, 2010a). However, 

53
certain markets or contracts may have defined thresholds (Non-GMO-Project, 2010). 

Individuals, grower associations or other private or public entities can establish isolation 

distances and other management practices to minimize gene flow from GE canola to non-GE,

organic-canola crops or other crops receptive to cross-pollination from GE canola, (e.g., 

countermeasures to protect seed crops of other cultivars of Brassica spp., established in Oregon 

(Oregon-Department-of-Agriculture, 2013)).

Preferred Alternative: Organic Canola Production

Approving the petition for non-regulation of 73496 canola status would not change the effects of 

canola farming on organic resources. Because the majority of canola production currently uses 

GE HR-canola varieties, the introduction of an additional GR variety with the same potential for 

cross-pollination as existing nonregulated GE canola varieties will not have any effect on future 

canola production practices. Since the production practices do not change under the preferred 

alternative, when compared to the No-action Alternative, there would be no changes in the direct 

or indirect effects on organic canola production.

4.3 Physical Environment

4.3.1 Water Resources

No-action Alternative: Water Resources

Canola cultivation may directly affect water resources through the use of local water sources for 

irrigation, or indirectly through associated management practices, including tillage and the use of 

agricultural inputs. The typical amount of water consumption during a growing season for 

successful canola production ranges up to 20 inches, depending on variety, management 

practices and the targeted yield (Hoeft et al., 2000). While normal climatic conditions may 

provide sufficient water to produce a crop, precipitation may vary across regions, so irrigation 

may be needed to supplement precipitation amounts.

In water, glyphosate is rapidly adsorbed onto suspended soil particles, and organic and mineral 

matter. It is degraded by microorganisms. Glyphosate resides in sediments underlying aerobic 

water have a half-life of seven days. In anaerobic aquatic sediment its residual half-life is 

approximately 208 days (US-EPA, 2009e).

The fate of glyphosate and its metabolite, AMPA, on a watershed scale in three Mississippi 

River basin watersheds was compared to results for a watershed in France (Coupe et al., 2011). 

They found that 1% or less of glyphosate is transported to surface water, although their samples 

frequently detected both glyphosate and AMPA (Coupe et al., 2011). Variability was correlated 

to differences in source strength, rainfall runoff, and flow route. The study concluded the 

watersheds most at risk for transport of glyphosate have high application rates, rainfall events 

resulting in overland runoff, and flow routes unfiltered by soil. 

The principal law governing pollution of the nation’s water resources, the Federal Water 

Pollution Control Act of 1972, which is also known as the Clean Water Act (CWA) (US-EPA, 

2011h). This CWA authorizes the establishment of water quality standards, permit requirements, 

and monitoring to establish a legal framework to protect and enhance domestic water quality. 

54
The EPA sets standards for water pollution abatement for all waters of the U.S. under the 

authority of this enabling legislation. In most cases, EPA extends to qualifying states the 

authority to issue and enforce permits. The CWA (33 U.S.C. 1251 et seq.) authorizes regulation 

of discharges of pollutants into the waters of the U.S. and the establishment of quality standards 

for surface waters. It is the principal U.S. legislation for safeguarding surface water, but it does 

not directly address groundwater or water quantity issues.

Surface water is an important natural resource used for many purposes, especially irrigation and 

public supply of drinking water and for everyday uses. The CWA authorizes a variety of 

regulatory and non-regulatory methods to:

• Reduce direct pollutant discharges into waterways;

• Finance municipal wastewater treatment facilities, and manage polluted runoff (USEPA, 2008);

• Manage NPS pollution, which results when runoff from rainfall, snowmelt, or irrigation 

moving over and through the ground accumulates natural and human-made pollutants 

that are ultimately transported into lakes, rivers, wetlands, coastal waters, and 

groundwater (US-EPA, 2011e). 

Glyphosate has not been identified as the cause of impairment to any water bodies classified as 

such under Section 303(d) of the CWA (US-EPA, 2011f).

Tillage is an important tool for managing weeds in crop production systems (Givens et al., 2009). 

Therefore, alternative management systems that reduce tillage and conserve crop residue can 

produce many water quality benefits, such as less sediment and chemical runoff entering surface 

water, reduced pesticide residues in surface water, improved moisture content in soil, and 

reduced potential for flooding (Fawcett and Towery, 2002). The positive impacts of reduced 

tillage are attributable to the increased amount of plant residue on the soil surface, which serves 

as a physical barrier to erosion and runoff, allowing more time for water absorption into the soil 

(Locke et al., 2008). The positive correlation between tillage reduction and the cultivation of 

herbicide-resistant crops has been documented (Fawcett and Towery, 2002). 

Glyphosate has a high affinity for binding with most types of soils, especially those with high 

organic content (Senseman, 2007). Because it is tightly bound to soil, transport of glyphosate to 

surface water by runoff from rain and irrigation occurs primarily by residue adsorbed on soil 

particles. This attribute also limits the mobility of glyphosate in soil and transport to 

groundwater.

Drinking water is protected under the Safe Drinking Water Act (SDWA) of 1974 (Public Law 

93-523, 42 U.S.C. 300 et seq.). The SDWA is the main Federal law that ensures the quality of 

U.S. drinking water. Under the SDWA, the EPA sets national health-based standards for 

drinking water quality to protect against both naturally-occurring and man-made contaminants 

that may be found in drinking water. The EPA also oversees the states, localities, and water 

suppliers who implement those standards (US-EPA, 2011f). The Sole Source Aquifer (SSA) 

designation under the SDWA is used to protect drinking water supplies in areas with few or no 

55
alternative groundwater resources, where contamination would require an extremely expensive 

replacement (US-EPA, 2011g). The EPA defines SSA as an aquifer that supplies at least 50% of 

the drinking water consumed in the area overlying the aquifer. There are 77 designated SSAs in 

the U.S. and its territories (US-EPA, 2011g) .

The potential for glyphosate to move into groundwater or surface waters is considered low (USEPA, 2009e). However, an exception to this observation has been reported for terrestrial 

applications made in close proximity to water bodies (WHO, 2005). 

Preferred Alternative: Water Resources

Approving the petition for nonregulated status would not change the effects of canola production

on water resources. Because the majority of canola production currently uses HR canola 

varieties and canola production is not expected to increase, the introduction of an additional GR

variety will have no effect on future canola production practices. Since the production practices 

do not change under the preferred alternative when compared to the No-action alternative, there 

would be no changes in the direct or indirect effects on water resources from the preferred 

alternative. 

4.3.2 Soil Quality

No-action Alternative: Soil Quality

Terrestrial plant production of any kind has the potential to modify substrate soil quality 

wherever crops are cultivated. Since soil is characterized by layers distinguished from the initial 

parent material that result from additions, losses, transfers, and transformations of energy and 

matter (USDA-NRCS, 1999), the intensity of disruption (e.g, depth and frequency of tillage) is a 

major factor determining the degree of impact. In addition to tillage, crops themselves impact 

soil quality because their root systems modify the soil environment and ultimately its ecology. 

Methods to improve soil quality include: careful management of fertilizer and pesticide 

applications; use of cover crops to increase plant diversity and reduce exposure time of soil 

lacking cover vegetation to wind and rain; use of buffer strips, contour strips, wind breaks, and 

crop rotation to promote landscape diversity (USDA-NRCS, 2006b). Tillage is an important tool 

for managing weeds in crop production systems (Givens et al., 2009). Strategies for minimizing 

its use (i.e., no-till and conservation tillage) also complement some of the methods mentioned 

here for enhanced sustainability of soil exposed to intensive cropping, as well as other 

advantages. For example, tillage management tends to minimize soil compaction by reducing 

frequency of tilling, so in general, reduced tillage minimizes the loss of organic matter and 

protects the soil surface by leaving plant residue on the surface. However, for some soil types 

(e.g., heavy clay soils), reduced or no-till practices are unsuitable because they may increase 

compaction (USDA-NRCS, 1996). Conventional tillage may also be a better option for

management of certain crop pests (USDA-NRCS, 2010). 

Management of residue is one of the most effective conservation methods to reduce wind and 

water soil erosion, and also benefits air and water quality, and wildlife (USDA-NRCS, 2006a). 

Reducing excessive tillage through conservation tillage minimizes the loss of organic matter and 

protects the soil surface by leaving plant residue on the surface. Since canola grows best in 

56
medium textured, well-drained soils (Oplinger, 1989), canola-producing cropland is well-suited 

for adoption of modified tillage practices.

Surface placement of crop residue with conservation tillage improves soil physical, chemical, 

and biological properties compared with incorporation of residues with conventional tillage. 

Management that uses intensive tillage and leaves low amounts of crop residue on the surface 

results in greater losses of soil organic matter (SOM). Intensive tillage turns the soil over and 

buries the majority of the residue, stimulating microbial activity and increasing the rate of 

residue breakdown (USDA-NRCS, 1996). The residues left after conservation tillage increase 

organic matter and improve infiltration, soil stability and structure, and the soil-borne microbial 

community (Fawcett and Caruana, 2001; USDA-NRCS, 2006b).

Organic matter is a vital component in maintaining soil quality (USDA-NRCS, 1996) by: 

• maintaining soil stability and structure;

• reducing potential for erosion;

• providing energy for microorganisms;

• improving infiltration and water-holding capacity;

• promoting nutrient cycles;

• increasing cation exchange capacity6

;

• metabolizing and detoxifying pesticides, other toxicants and naturally occurring toxins.

Current canola cultivation impacts are caused primarily by tillage and harvesting equipment that 

tend to disturb and expose the top soil horizon. This makes the surface soil layer more 

susceptible to degradation from erosion by wind and runoff than soil that maintains a vegetated 

surface layer. Some of the most serious consequences of such soil degradation include decreased 

water retention, reduced accretion and sequestration of soil-borne carbon, and increased emission 

of greenhouse gases (e.g, carbon dioxide and nitrous oxide (Lal and Bruce; U.S. EPA, 2010c)). 

Other potential negative impacts of degraded soil are indirect effects, such as reduced local 

surface water quality and the disruption of communities of organisms whose survival is 

contingent on that resource.

Fertilization may be used by canola growers. In general, canola requires 25% more nitrogen, and 

similar amounts of phosphorous and potassium to winter wheat, but canola requires slightly 

higher amounts of sulfur than wheat (Atkinson et al., 2006). Optimal soil pH for canola ranges 

from 5.8 to 6.2. Producers apply nitrogen, phosphorus, sulfur, and potassium in the spring before 

or at planting. Sulfur requirements are higher than for other crops. New crop varieties that are 

6 Cation Exchange Capacity is the ability of soil anions (negatively charged clay, organic matter and inorganic 

minerals such as phosphate, sulfate, and nitrate) to adsorb and store soil cation nutrients (positively charged ions 

such as potassium, calcium and ammonium).

57

 
resistant to herbicides have helped to decrease the risk and effort associated with canola 

production (USDA-ERS 2012 yearbook; Atkinson et al., 2006). 

The increased residue from conservation tillage increases in the top three inches of the soil and 

protects the surface from erosion, while maintaining water-conducting pores. Soil aggregates in 

conservation tillage systems are more stable than those in conventional tillage because of the 

enhancing effects of products from SOM decomposition and the presence of soil microbial flora 

(e.g., bacteria and fungi). Hyphae (filamentous structures that are the predominant growth form 

of fungi) are especially effective in binding aggregates and soil particles together (USDA-NRCS, 

1996). Although soil erosion rates in crop production are dependent on numerous local 

conditions such as soil texture and crop type, comparative studies contrasting conventional and 

no-till practices found that no-till practices were significantly more effective in reducing erosion 

than conventional tillage (Montgomery, 2007). This reduction enables soil production to nearly 

replace soil losses from erosion. From 1982 through 2003, the estimated U.S. cropland erosion 

rate declined from 3.1 billion tons per year to 1.7 billion tons per year (USDA-NRCS, 2006a). 

This positive impact is partially attributable to effective weed control derived from herbicide 

applications that vastly reduce dependence on mechanical (tillage) methods (Carpenter et al., 

2002).

Even in the absence of herbicide applications, conservation tillage tends to provide a competitive 

advantage to canola production by promoting earlier crop emergence (Bullied et al., 2003). The 

introduction of HR canola increases the effectiveness of weed control making conservation 

tillage a more feasible option (Fawcett and Towery, 2002).

Glyphosate is rapidly bound (adsorbed) to soil particles. Its adsorption rate in soil is minimally 

influenced by pH, organic matter content, and the ratio of clay, silt and sand composing a 

particular soil type. Soils high in phosphorus decrease adsorption (Senseman, 2007), which 

increases its availability for plant uptake, microbial degradation, and leaching (Kremer and 

Means, 2009). However, because glyphosate tends to bind in most soils, this reduces its 

degradation rate. Since degradation is mediated by microbial action, the rate is also influenced 

by the species composition of microorganisms within the rhizosphere. The combined effect of 

these two important factors influencing degradation of glyphosate have been shown to result in 

an average half-life in soil of 47 days (Senseman, 2007) with a range of 2.4 to 160 days (USEPA, 2009e).

Several reports indicate that glyphosate interacts with manganese by forming insoluble, stable 

complexes that either immobilize this element, or reduce plant uptake, preventing reduction in 

the plant and making it unavailable (Eker et al., 2006; Neumann et al., 2006; Ozturk et al., 2008; 

Cakmak et al., 2009; Huber, 2010). Huber (2010) and Cakmak (2009) also reported that 

glyphosate is a broad-spectrum chelate of several other nutrients (iron, calcium, magnesium, 

copper, iron, nickel and zinc). However, a clear consensus has not evolved among researchers 

studying the dynamics of these processes. Hartzler (2010), for example, agrees that glyphosate 

could immobilize essential elements temporarily, but does not believe that it specifically targets 

manganese or any other particular element. Instead, this interpretation indicates that it targets 

58
those cations7 that are most prevalent in soil. Hartzler (2010) also reported that areas for which 

glyphosate interactions with manganese are described are limited to those with known soil 

manganese deficiencies. Camberato (2010) noted that manganese deficiency is not a new 

phenomenon and is also associated with high pH, low moisture, or high levels of organic matter. 

Regardless of the cause(s), its deficiency is recognizable and can be resolved through foliar 

application(s) of manganese fertilizers (Camberato et al., 2010). 

Preferred Alternative: Soil Quality

Approving the petition for nonregulated status would not change the effects of canola farming on 

soil quality. Because the majority of canola production uses HR canola varieties and canola 

production is not expected to increase, the introduction of an additional GR variety will have no 

effect on the production practices currently employed in canola. As described in the No-action 

Alternative, the effects of canola production on soil quality result from the types of production 

practices employed. Since the production practices do not change under the preferred alternative 

when compared to the No-action alternative, there are no changes in the direct or indirect effects 

on soil quality from the preferred alternative when compared to the baseline (No-action

alternative).

4.3.3 Air Quality

No Action: Air Quality 

The Clean Air Act (CAA) requires the maintenance of National Ambient Air Quality Standards 

(NAAQS). The NAAQS, developed by the EPA to protect public health, establishes limits for 

six criteria pollutants: ozone (O3), nitrogen dioxide (NO2), carbon monoxide (CO), sulfur 

dioxide (SO2), lead (Pb), and coarse (inhalable) particulate matter (PM) greater than 2.5 

micrometers and less than 10 micrometers in diameter (PM10), and fine particles less than 2.5 

micrometers in diameter (PM2.5). The CAA requires states to achieve and maintain the NAAQS 

within their borders. Each state may adopt requirements stricter than those of the national 

standard and each is required by the EPA to develop a State Implementation Plan (SIP) that 

contains strategies to achieve and maintain the national standard of air quality within the state. 

Areas that violate air quality standards are designated as non-attainment areas for the relevant 

pollutants, whereas areas that comply with air quality standards are designated as attainment 

areas. Primary sources of emissions associated with crop production include exhaust from 

motorized equipment such as tractors and irrigation equipment, soil particulates from tillage,

wind-induced erosion, burning of fields, and spraying of herbicides and pesticides. Emissions 

contributing to GHGs associated with global warming are discussed in Subsection 4.3.4, Climate 

Change.

Pesticide and herbicide spraying introduce air quality impacts from drift and diffusion. Drift is 

defined by the EPA as “the movement of pesticide through air at the time of application or soon 

7 A cation ion is an element with a positive charge (missing electrons) such as iron (Fe2+), manganese (Mn2+), 

calcium (Ca2+), potassium (K+

) and sodium (Na+). 

59

 
thereafter, to any site other than that intended for application” (US-EPA, 2000). Diffusion is 

gaseous transformation to the atmosphere (FOCUS, 2008). Factors affecting drift and diffusion 

include application equipment and method, weather conditions, topography, and the type of crop 

being sprayed (US-EPA, 2000). The EPA is currently evaluating new regulations for pesticide 

drift labeling and the identification of BMPs (best management practices) to control such drift 

(US-EPA, 2009d), as well as identifying scientific issues surrounding field volatility of 

conventional pesticides (US-EPA, 2010).

Chang et al. (2011) recently evaluated the occurrence and fate of glyphosate and its metabolite, 

AMPA, in the atmosphere and in rainfall in the Mississippi River basin. They found the 

frequency of glyphosate in the air was similar to that of other commonly applied herbicides such 

as atrazine and metolachlor, but its incidence in rain was higher, primarily because of widespread 

use of glyphosate for crop production in the region (Chang et al., 2011). AMPA in air was 

sampled at a range of 0 to 1.0 as a fraction of glyphosate. Early in the application season it was 

lower, but increased as glyphosate degraded in soil to produce the metabolite. Its incidence in 

rain was similar. The study also investigated the source of glyphosate in the air and found most 

occurred from spray application rather than volatilization or transport from windborne soil. 

Chang et al. (2011) concluded that up to 97% of glyphosate may be removed from the 

atmosphere by weekly rainfall greater than 30 millimeters (1.18 inches). 

Other conservation practices, as required by the USDA to qualify for crop insurance and 

beneficial federal loans and programs (USDA-ERS, 2009), effectively reduce crop production 

impacts to air quality through the use of windbreaks, shelterbelts, reduced tillage, and cover 

crops that promote soil protection on highly erodible lands. 

Preferred Alternative: Air Quality

Approving the petition for nonregulated status would not change the effects of canola farming on 

Air Quality. Because the majority of canola production uses HR canola varieties and canola 

production is not expected to increase, the introduction of an additional GR variety will have no 

effect on the production practices currently employed in canola. As described in the No-action 

Alternative, the effects of canola production on air quality result from the types of production 

practices employed. Since the production practices do not change under the preferred alternative 

when compared to the No-action Alternative, there are no changes in the direct or indirect effects 

on air quality from the preferred alternative when compared to the baseline (No-action 

Alternative).

4.3.4 Climate Change

No-action Alternative: Climate Change

Climate change represents a statistical change in global climate conditions, including shifts in the 

frequency of extreme weather, that may be measured across time and space (Cook et al., 2008; 

Karl et al., 2008). Agriculture is recognized as a direct (e.g, exhaust from equipment) and 

indirect (e.g, agricultural-related soil disturbance) source of GHG emissions (Rosenzweig and 

Parry, 1994; Dale, 1997; Fargione et al., 2008; Gutowski et al., 2008; Piñeiro et al., 2009; U.S. 

EPA, 2010a). GHGs, including CO2, methane (CH4), and N2O, function as retainers of solar 

60
radiation (Aneja et al., 2009). The U.S. agricultural sector is second only to energy production 

as a contributor to GHG emissions (U.S. EPA, 2010a).

U.S. agriculture may influence climate change through various facets of the production process 

(Horowitz and Gottlieb, 2010) and conversion of land to agriculture. CH4 and N2O are the 

primary GHGs emitted by agricultural activities. The major sources of GHG emissions 

associated with crop production are soil N2O emissions, soil CO2 and CH4 fluxes, and CO2

emissions associated with farm equipment operation (Adler et al., 2007). Over the 20-year 

period, 1990-2009, total emissions in the agriculture sector increased 8.7%. By 2009, 7% of 

total U.S. GHG emissions were attributed to agricultural sources (US-EPA, 2011b).

N2O emissions are estimated at 69% of all U.S. N2O emissions (US-EPA, 2011b). These are

attributed to soil management activities including fertilizer application and cropping practices, so 

agriculture represents the largest source of this GHG.

Agricultural practices that produce CO2 emissions include liming and the application of urea 

fertilization to agricultural soils. Emissions from intestinal (enteric) fermentation and manure 

management represent about 20% and 7% respectively of total CH4 emissions from 

anthropogenic activities (US-EPA, 2011b). In 2009, the use of lime and urea fertilizers resulted 

in an 11% increase of CO2 relative to 1990 emissions (US-EPA, 2011b). The agricultural sector 

also produces CO2 emissions from fossil-fuel combustion and farm equipment such as tractors as 

discussed in Subsection 2.2.3, Air Quality.

Soil-disturbing practices such as tillage can result in the release of sequestered organic carbon, 

which is produced by the remains of microorganisms (fungi, bacteria, etc.), in non-living organic 

matter and attached to inorganic minerals in the soil. Agriculture may also affect dynamic soil 

processes through tillage and other land management practices (Smith and Conen, 2004). In 

general, conservation tillage strategies are associated with more stable and increased carbon 

sequestration resulting from a net reduction in carbon dioxide emissions (Lal and Bruce, 1999; 

West and Marland, 2002).

Several reports indicate that the relationship between conservation tillage and increased carbon 

sequestration requires more study, as soil depth and seasonal sampling bias may inadvertently 

affect measurements (Angers et al., 1997; Potter et al., 1998; Wanniarachchi et al., 1999; West 

and Marland, 2002; Baker et al., 2007; Oorts et al., 2007). The relationship between different 

GHG emissions, such as carbon dioxide and nitrous oxide, can require modifications to models 

related to tillage strategies and global climate change (Gregorich et al., 2005). For example, 

increased nitrous oxide emissions as a result of conservation tillage strategies may offset any 

gains achieved through increased carbon sequestration.

As is also true of the relationship between conservation tillage strategies and carbon 

sequestration, a broad generalization regarding the impact of tillage on nitrous oxide emissions is 

difficult. Numerous factors influence soil nitrification cycles, including geographic location, soil 

structure, moisture, and farm-level management practices, including, but not limited to, those

that relate to fertilizer and pesticide applications (Linn and Doran, 1984; Palma et al., 1997; 

MacKenzie et al., 1998; Campbell, 2003; Elmi et al., 2003; Gregorich et al., 2005; Grandy et al., 

2006; Gregorich et al., 2006; Metay et al., 2007; Ball et al., 2008; Del Grosso et al., 2008; 

61
Farahbakhshazad et al., 2008; Halvorson et al., 2008; Philippe, 2008; Rochette et al., 2008; 

Almaraz et al., 2009; Poirier et al., 2009).

Using baseline data for 1996-2004 U.S. and Canadian canola production combined, Brookes and 

Barfoot, 2004 estimated the impact on GHG emissions. They concluded that there was a

reduction (94M kg of CO2) that resulted from reduced fuel usage attributable to reduced tillage 

requirements. They also estimated that an additional 906M kg of CO2 was sequestered by 

reducing soil tillage. 

Preferred Alternative: Climate Change

Approving the petition for nonregulated status would not change the effects of canola farming on 

climate change. Because the majority of canola production uses HR-canola varieties and canola 

production is not expected to increase, the introduction of an additional GR variety will have no 

effect on the production practices currently employed in canola. As described in the No-action 

Alternative, the effects of canola production on climate change result from the types of 

production practices used. Since the production practices do not change under the preferred 

alternative when compared to the No-action Alternative, there are no changes in the direct or 

indirect effects on climate change from the preferred alternative when compared to the baseline 

(No-action Alternative).

4.4 Biological Resources

4.4.1 Animal Communities

No-action Alternative: Animal Communities

Invertebrates that feed on canola are typically considered pest organisms 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 the population causes damage at certain economic levels (NDSU, 2011). 

Vertebrate animals may consume canola plants or seed. Canola forage can have a protein 

content of 21-33%.(Oplinger, 1989) It is about 40% oil, which can make it a high-energy food 

source for some wildlife. Turkey and deer may graze on canola. Therefore, it is not 

recommended for planting in fields where animal damage from these organisms occurs

(Pennsylvania-State-University-Extension-Service, no date). Some State departments of fish and 

wildlife recommend planting canola as a fall or winter forage (Kentucky-Department-of-Fishand-Wildlife-Resources, 2010). Companies also market canola seed as an attractant to wildlife 

(Elk-Mound-Seed-Company, No date).

Preferred Alternative: Animal Communities

Pioneer 73496 Canola is compositionally similar to other canola varieties currently available

with the exception of an increase in acetylated amino acid concentration (Pioneer, 2011). Based

on the studies included in the petition, NAA (N-acetylaspartate) and NAG (N-acetylglutamate) 

were significantly different than the near isogenic control and were also outside of the statistical 

tolerance interval for canola in seed and whole plant samples. These results indicate that there is 

62
more NAA and NAG than would be found in other canola varieties. Two other acetylated amino 

acids, NAS (N-acetylserine) and NAT (N-acetylthreonine), were also identified to be at higher 

levels (statistically) than the near isogenic control. These acetylated amino acid levels were 

within the tolerance interval, indicating that other canola varieties could have similar levels of 

these two acetylated amino acids. 

Animals that consume 73496 canola plants or seeds may be exposed to higher levels of NAA and 

NAG than in other canola. However, these two acetylated amino acids are normal parts of 

metabolism in mammals. NAA is found in the central nervous system of mammals (Moffett et 

al., 2007). NAG is found in organs like the liver, spleen, kidneys and heart of many animal 

species (Shigesada and Tatibana, 1971). Pioneer conducted toxicity studies (Delaney et al., 

2008; Harper et al., 2009; Karaman et al., 2009; Delaney, 2010; Karaman et al., 2011) and did 

not find any acute, chronic, sub-chronic, or mutagenic effects for feeding studies associated with 

these acetylated amino acids.

Since there are no acute, chronic, sub-chronic, or mutagenic effects associated with 

compositional changes associated with expression of the transgene in 73496 canola the effects of 

the preferred alternative on wildlife are not different that the no action alternative.

4.4.2 Plant Communities

No-action Alternative: Plant Communities

Plants that grow in canola fields are considered weeds by growers. Weeds can compete with 

growing canola plants for resources such as water, light, and soil nutrients. Young canola 

seedlings are very sensitive to early weed competition. Growers control weeds using cultural, 

mechanical and chemical methods. Once established, however, canola is a good competitor with 

most weeds.

Most canola grown in North America is HR. These varieties allow for over-the-top herbicide 

application of the post-emergent canola plants. The herbicide kills the nonresistant plants 

(weeds) but not the canola. There are currently three different types of HR canola (Brown et al., 

2008). By 2006, 99% of the canola acreage in North Dakota was planted in an HR variety (see 

Table 11 for varieties). In the same year, 78% of the Minnesota canola acreage was planted in 

HR varieties (Johnson et al., 2007). About 56% of the canola grown in ND was GR, 40%

glufosinate-resistant, and 2% imidazolinone-resistant (Zollinger et al., 2008).

Some plants in and around canola fields are specifically targeted with weed management 

strategies that include the use of herbicides. Herbicide resistant weeds can be a problem in 

agricultural systems because frequent use of a particular herbicide can decrease its effectiveness. 

A summary of weeds that are resistant to herbicides in the 25 states that consistently produce 

canola appears in Table 12. Weeds of particular concern to canola growers include kochia and 

wild oat (see Table 2 for frequency of weeds in canola fields in North Dakota). Table 12 shows 

the herbicides currently used to control weeds in canola in North Dakota. Canola can be 

damaged or killed by residues of certain herbicides in the soil. Therefore, there are plant-back 

restrictions for many of the herbicides that are applied to control vegetation prior to canola 

planting, or are applied to previous rotational crops such as cereals (Table 6). For example, 

63
canola cannot be planted for 40 months following application of imazethapyr unless the canola is 

an imidazolinone-resistant variety.

Table 11: Herbicides and Application Methods Used in North Dakota Canola Production in 

20081.

Herbicide

Acres

treated2

Acres

treated

Number of

Applications

Operator/

Applicator

1 2 Farm Custom

1000 % % % % %

Clethodium 123.6 13.6 100.0

0.6

89.0 11.0

Glufosinate-ammonium 354.3 38.9 99.4 90.2 9.8

Glyphosate 660.3 72.6 58.0 42.1 88.9 11.1

Imazamox 21.2 2.3 48.4 51.6 89.1 10.9

Quizalofop-p-ethyl 31.7 3.5 100.0 NA3 100.0 NA

Unknown or other 

herbicide 29.2 3.2 100.0 NA 100.0 NA

Total 1220.3 134.1 76.2 23.8 89.8 10.2

1

Pesticides applied as a tank-mixture were considered separately unless a commercial premix was used. 2

Multiple applications to the same acre were reported as separate values. Acres treated can exceed 100% of the 

planted acres. 3

Data not available

Source: (Zollinger et al., 2008)

A recent Canadian study assessed the environmental impact of HR canola (Smyth et al., 2011). 

This study surveyed nearly 600 canola farmers and asked them about their crop production 

experience in 2005-2006 and expected crop planting in 2007. They concluded that annual

herbicide use was reduced by nearly 1.3M kg annually. Tillage also declined on land used to 

grow HR canola, and an estimated 1M tons of carbon was either sequestered or no longer 

released, compared to what prevailed in 1995 (Smyth et al., 2011). In the northern U.S., it is 

likely that similar results could be expected from the production of HR canola. HR weeds, 

including weeds resistant to glyphosate, can be found in areas where canola is grown (see Figure 

6). In fields with GR weeds, growers may choose to grow glufosinate- or imidazolinoneresistant varieties. They may also choose to use cultural practices, or alternative herbicides. 

64
North Dakota publishes a weed management guide8 that includes recommendations for weed 

management in canola.

Oregon

Italian ryegrass

California

Hairy fleabane

Horseweed

Junglerice

Rigid ryegrass

Oklahoma

Horsesweed

Common waterhemp

New Mexico

Palmer amaranth

Nebraska

Horseweed

Giant ragweed

Kochia

Kansas

Common ragweed

Common waterhemp

Giant ragweed

Horseweed

Kochia

North Dakota

Common ragweed

Common waterhemp

Kochia

Missouri

Annual bluegrass

Common ragweed

Common waterhemp

Giant ragweed

Horseweed

Palmer amaranth

Arkansas

Common ragweed

Giant ragweed

Horseweed

Italian ryegrass

Johnsongrass

Palmer amaranth

Minnesota

Common ragweed

Common waterhemp

Giant ragweed

Iowa

Giant ragweed

Common waterhemp

Horseweed

Illinois

Common waterhemp

Horseweed

Palmer amaranth

Louisiana

Johnsongrass

Palmer amaranth

Indiana

Common ragweed

Common waterhemp

Giant ragweed

Horseweed

Ohio

Common ragweed

Giant ragweed

Horseweed

Common waterhemp

Palmer amaranth

Mississippi

Common waterhemp

Giant ragweed

Goose Grass

Horseweed

Italian ryegrass

Palmer amaranth

Johnsongrass

Virginia

Pennsylvania

Maryland

Delaware

New Jersey

Kentucky

Horseweed

Michigan

Palmer amaranth

Horseweed

Tennessee

Giant ragweed

Goose Grass

Horseweed

Palmer amaranth

Common waterhemp

North Carolina

Horseweed

Palmer amaranth

Common ragweed

Glyphosate-Resistant Species 1 2 3 4 5 6 7

Alabama

Georgia

Palmer 

amaranth

Figure 6: Distribution of Glyphosate-resistant Weeds in the U.S.

Source: WSSA, 2012 (Accessed Dec 14, 2012)

Feral populations of herbicide resistant canola, containing one or more herbicide resistant traits 

have been identified in areas where canola is commercially grown(Warwick et al., 2003; Schafer 

et al., 2011). Management of herbicide resistant canola is discussed in the PPRA (USDAAPHIS, 2013). 

Glyphosate has a low vapor pressure, so volatilization from soils is not considered an important 

dissipation mechanism (US-EPA, 1993b). Drift beyond the target site can occur. One study has 

indicated that drift from glyphosate can provide a selective advantage to the backcross 

generation between GR B. rapa hybrid canola in a controlled environment. The study also 

indicated that drift could impact the flowers of the B. rapa plant decreasing the likelihood of 

cross-pollination between the GE crop and the non-GE weed (Londo et al., 2010). The authors 

conclude:

In cases of early-flowering B. rapa, a delay in flowering phenology 

due to drift-level concentrations of glyphosate at a field boundary 

8 http://www.ag.ndsu.edu/weeds/weed-control-guides/nd-weed-control-guide-1

65

 
may encourage transgene flow by synchronizing flowering 

phenologies of both the crop and weed. However, later-flowering 

genotypes of B. rapa could also be desynchronized from B. napus

flowering when exposed to glyphosate drift, reducing the potential 

for transgene gene flow (Londo et al., 2010). 

The authors also indicate that additional study is needed to determine if these effects occur in the 

field.

Preferred Alternative: Plant Communities

Under the preferred alternative, production practices associated with canola are expected to 

remain the same as the No-action Alternative. Therefore, there is no evidence that effects on 

plant communities from 73496-Canola production will differ from those that occur in 

conjunction with other GR-canola currently marketed. 

Although the frequency is low, 73496 canola crosses with other mustard species (USDA-APHIS, 

2013). However, this frequency is the same as that for other commercially-grown GE canola. 

Therefore, just as alleles from currently available canola varieties can introgress into other 

sexually compatible, co-localized mustard plants, this too is likely to happen with 73496 canola. 

No difference is expected in the rate of introgression for 73496 canola alleles into other sexually 

compatible mustards when compared to currently available canola varieties.

4.4.3 Microorganisms

No-action Alternative: Microorganisms

Soil microorganisms are important in soil structure formation, decomposition of organic matter, 

toxin removal, nutrient cycling, and most biochemical soil processes (Garbeva et al., 2004). 

They may also suppress soil-borne plant diseases and promote plant growth (Doran et al., 1996).

The main factors affecting microbial population size and diversity include soil and plant type, 

and agricultural management practices (e.g., crop rotation, tillage, herbicide and fertilizer 

application, and irrigation) (Garbeva et al., 2004). Plant roots, including those of canola, release 

a variety of compounds into the soil creating a unique environment for microorganisms in the 

rhizosphere. GE plants potentially impact soil microbes directly from the transfer of introduced 

genetic material, exposure to expressed proteins through root exudation and crop residue 

incorporated into soil, or changes in agronomic practices used to produce crops. Indirect impacts 

may arise from changes in the amount and composition of residue from crops. 

Gene transfer between microorganisms is common (Keese, 2008; McDaniel et al., 2010). 

However, biodegradation of plant materials tilled into soils generally results in fragmentation of 

DNA strands into small pieces (Lerat et al., 2007; Levy-Booth et al., 2008; Hart et al., 2009). 

The potential for protein conveying glyphosate resistance to remain functional in soils is remote

because the protein degrades once it is released from cells, and then decays in soils (Australian 

Government, 2006). Studies of the impact of GE crops on soil microbial communities have 

indicated there have been minor to no non-target effects, but induced targeted alterations to the 

composition of the microbial community have usually resulted in the inhibition of plant 

pathogenic organisms (Kowalchuk et al., 2003). 

66
Root exudates have been found to promote certain microbial populations, such as soybeans 

symbiotic relationship with nitrogen-fixing bacteria, and other free-living microbes that have coevolved with plants that supply nutrients to and obtain food from their plant hosts (USDANRCS, 2004; Bais et al., 2006).

Crop rotation, irrigation, tillage, and agricultural chemicals such as fertilizers and pesticides 

affect microbial community structure and functions such as nutrient cycling, disease promotion 

or suppression, and presence in soil. An agronomic practice may be beneficial for one 

microorganism but detrimental to another. For example, the primary agents degrading 

glyphosate in soil and water are microorganisms feeding on the herbicide (Senseman, 2007). 

Reviews of studies investigating the impact of glyphosate on soil microorganisms found that 

numerous studies did not detect adverse effects under field use conditions, or found only minor 

effects that could not be separated from changes in habitat. Others reported effects at or near 

normal glyphosate use rates, but in most cases, the effects were temporary (Giesy et al., 2000). 

Some studies have implicated glyphosate as a cause for increases in the population and virulence 

of certain plant diseases, and for producing increased susceptibility to some diseases in GR-crop 

varieties (as reviewed in Johal and Huber, 2009). The authors suggest measures to minimize this 

potential that include using the minimum amount of glyphosate necessary for weed management, 

amending soils with micronutrients, detoxifying meristematic (i.e., growth) tissues by adding 

chelating agents to the soil, and detoxifying root exudates through the regular inoculation of 

nitrogen-fixing organisms (Johal and Huber, 2009). 

APHIS has previously examined in detail the potential impacts of glyphosate on microorganisms 

in cultivation of GR alfalfa and sugar beets (USDA-APHIS, 2010; USDA-APHIS, 2011). To 

date, there is no conclusive evidence linking applications of glyphosate to changes in soil 

microbial communities that have adverse effects on plants grown in those soils.

Preferred Alternative: Microorganisms

The preferred alternative is not expected to result in any new impacts to microbial communities

when compared to the No-action Alternative. Since the use of glyphosate for canola production 

is not expected to change under the Preferred Alternative when compared to the No-action 

Alternative, there would be no change to potential impacts to microorganisms from glyphosate 

use from those of the No-action Alternative. 

After harvest, residue of 73496 canola will remain at the site of cultivation. These crop residues 

will likely contain very small amounts of the novel protein GAT4621. The GAT protein was 

developed by a DNA shuffling process using three native gat genes from Bacillus licheniformis 

as parental templates (Castle et al., 2004). Bacillus licheniformis is a common saprophytic 

bacterium that is widespread in nature, especially in soils. It has been used in the fermentation 

industry for production of proteases, amylases, antibiotics, and specialty chemicals for over a 

decade with no known reports of adverse effects to human health or the environment (US-EPA, 

1997). Hence, enzymes closely related to the GAT4621 protein are already present in soils. 

Moreover, the GAT4621 protein will be susceptible to degradation and adsorption to humus or 

minerals as are other proteins in agricultural soils. Soils contain numerous organisms and 

enzymatic activity from decomposed organisms that degrade a wide array of molecules including 

proteins (Bastida et al., 2009). These processes would metabolize or sequester the GAT4621 

67
protein with no likely effect on the soil. Therefore there should be no unique impacts on soil 

resulting from residue of 73496 canola.

4.4.4 Biodiversity

No-action Alternative: Biodiversity 

All plants, animals and microorganisms interacting in an ecosystem contribute to biodiversity 

(Wilson, 1988a). In agriculture, biodiversity contributes to critical functions such as pollination, 

genetic introgression, biological control, nutrient recycling, and other important processes. 

Significant impacts on any of these functions could require costly management (Altieri, 1999). 

Concerns regarding the potential impacts to biodiversity associated with the introduction of GE 

crops (and crops in general) include the loss of diversity, which can occur at the crop, farm, 

and/or landscape scale (Visser, 1998; Ammann, 2005; Carpenter, 2011). 

At the farm scale, agronomic practices that can impact biodiversity include cropping practices 

(e.g., strip or contour cropping, crop rotation), soil conservation practices that maintain grass 

strips, windbreaks and shelterbelts, tillage, and the application of agrochemicals. Rotation of 

crops and strip contour cropping provides varied habitat that can benefit biodiversity. 

Establishment of soil-conserving grass and other vegetative borders stabilizes soil that maintains 

additional wildlife habitat. It also improves the quality of existing habitat (such as surface water 

quality) that contributes to biodiversity. Allowing unproductive field edges to become managed 

wildlife habitat promotes diversity in both plants and animal species (Sharpe, 2010).

Glyphosate effectively kills grass and broadleaf plants when applied at the recommended rates. 

At the farm scale, herbicide use in agricultural fields may impact biodiversity by decreasing 

weed populations or causing a shift in weed species present in the field. This may affect the 

species composition of insects, birds, and mammals that utilize these weeds. The quantity and 

type of herbicide use associated with HR canola, however, is dependent on many variables, 

including cropping systems, type and abundance of weeds, production practices, and individual 

grower decisions. 

Use of HR crops, such as canola, has been correlated with an increase in conservation tillage in 

U.S. crop production (Givens et al., 2009). This promotes biodiversity by allowing the 

establishment of other plants between crop rows, and the accumulation of more plant residue that 

creates more soil organic matter, food, and cover for wildlife. In a review of literature that 

assessed the impacts of GE crops on biodiversity, Carpenter (2011) found a trend indicating that

impacts to biodiversity have been positive because of increased yields, decreased applications of 

insecticides, use of less toxic herbicides, and facilitation of conservation tillage. 

Crop production in general impacts biodiversity at the landscape scale because its establishment 

represents conversion of natural habitats to monocultures. Herbicide applications may 

negatively impact species that are dependent on the targeted weeds, which also reduces diversity. 

Potential impacts to landscape-scale diversity can be related to the effects of herbicides on nontarget animal and plant species.

Assessments of the toxicity of glyphosate to animal species indicate a minimal risk to animals, 

but it is toxic to targeted plants and may affect non-targeted plants and animals through spray 

68
drift, volatilization (i.e., evaporation) and runoff. Inadvertent exposure may cause adverse 

effects that could lead to a decrease in biodiversity. However, glyphosate was found by the 

EPA to be only slightly toxic to birds, and practically nontoxic to fish, aquatic invertebrates and 

honeybees (US-EPA, 1993b).

The EPA is currently evaluating additional labeling requirements concerning BMPs for 

controlling pesticide spray drift. While herbicide use potentially affects biodiversity, the 

application of pesticides in accordance with registered uses and label instructions, and careful 

management of chemical spray drift, minimizes impacts. 

In 2009, the EPA initiated reregistration of glyphosate and has identified additional data needs. 

Part of the risk assessment will include an acute avian oral toxicity study for passerine species. 

Some inert ingredients used as surfactants are more toxic than glyphosate to aquatic organisms. 

These will also be evaluated for acute toxicity to estuarine and marine mollusks, invertebrates, 

and fish (US-EPA, 2009b). 

Preferred Alternative: Biodiversity

Under the Preferred Alternative, a grower may have an additional GR variety commercially 

available. Production practices, including herbicide use will be similar to other currently 

available GR-canola varieties. Therefore, the effects of canola production on biodiversity will 

not change from the No-action Alternative.

Based on past trends in HR canola adoption (see figure 4) and future predictions for HR canola 

adoption (see figure 5) 73496 canola, another GR-canola option, would likely only replace other

GR varieties. Therefore, it would not promote expansion of canola acreage, so would not cause 

impacts on biodiversity by increasing habitat loss through conversion of natural landscape to 

cropland. 

Based on the above information, APHIS has concluded that the preferred alternative would not 

effect crop-, farm-, or landscape-scale biodiversity differently than the No-action Alternative.

4.5 Human Health

4.5.1 Consumer Health

No-action Alternative: Consumer Health

Consumers are exposed to canola products, typically oil and sometimes meal. Both canola meal 

and canola oil are classified as GRAS by FDA (21 CFR 184). More than 50% of the canola 

grown in the U.S. is GR. Human health concerns associated with GE crops include the potential 

toxicity of the introduced gene(s) and their products, such as the expression of new antigenic 

69
proteins, and/or altered levels of existing allergens (Malarkey, 2003; Dona and Arvanitoyannis, 

2009). All currently available GE canola varieties have completed a consultation with FDA9. 

Under the No-Action Alternative, agricultural production of nonregulated GE and non-GE 

canola use EPA-registered pesticides for plant pest management of weeds, insects and other 

pests. The environmental risks of pesticide use are assessed by the EPA in the pesticide 

registration process. All pesticides are reevaluated regularly by the EPA to maintain and update 

their registration status under FIFRA.

The human health effects from exposure to glyphosate have been thoroughly evaluated by the 

EPA. The 1993 glyphosate RED presents the data used by the EPA for chemical reregistration 

(see US-EPA, 1993b). The review for reregistration began in July 2009. EPA is currently 

conducting a comprehensive human health assessment for all uses of glyphosate and its salts 

(US-EPA, 2009b). The glyphosate RED presents the EPA analysis of the toxicity, 

carcinogenicity, and developmental toxicity of this herbicide. Glyphosate is classified as having 

low toxicity via the oral, dermal, and inhalation routes, and is not classified as a carcinogen or 

teratogen (US-EPA, 2009b; US-EPA, 2009c). Acute, subchronic, chronic, developmental, and 

reproductive studies to date indicate that glyphosate is not neurotoxic, although additional 

studies will occur as part of the current review process (US-EPA, 2009c). Based on additional 

toxicity tests, the EPA determined the main glyphosate metabolite AMPA does not require 

regulation (US-EPA, 2009c). 

Pesticide tolerances for glyphosate on canola have been established (US-EPA, 2011d). 

Tolerances are the maximum residue concentrations allowable for pesticide that may remain on 

or in foods marketed in the U.S. These levels are established for every pesticide, based on its 

potential risks to human health. The EPA tolerance for glyphosate on both canola seed and 

rapeseed is 20 ppm.

Preferred Alternative: Consumer Health

The gat4621 gene comes from soil bacterium B. lichiniformis. There are no toxins associated 

with this bacterium which is widely used in the food industry (US-EPA, 1997). A comparison of 

amino acid sequence of GAT4621 with known toxins failed to show any significant homologies 

(Pioneer, 2011; see section VI-D for a summary of the findings). There was no evidence of 

acute toxicity in mice for GAT4621 at a dose of 1640 mg protein per kg of body weight 

(Pioneer, 2011; see Appendix 10). Based on these studies, the GAT4621 protein is unlikely to be 

a human or animal toxin. 

According to the petition, bioinformatic analyses revealed no biologically significant identities to 

known or putative protein allergens or toxins for the GAT4621 protein sequences (see Petition, 

Appendix 10). The GAT4621 protein is not glycosylated and is rapidly digested (within 30 

seconds) in simulated gastric fluid. In simulated intestinal fluid, the GAT4621 protein 

hydrolyzed within 5 minutes. These data support the conclusion that the GAT4621 protein is 

9 See http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=bioListing for list of completed 

consultations.

70

 
unlikely to cause an allergic reaction in humans or be a toxin in humans or animals and therefore 

support the food and feed safety of GAT4621. 

Although the primary substrate of the GAT4621 protein is glyphosate, GAT4621 is also known to Nacetylate certain free amino acids (L-aspartate, L-glutamate, glycine, L-serine, and L-threonine) 

resulting in production of N-acetylaspartate (NAA), N-acetylglutamate (NAG), N-acetylglycine 

(NAGly), N-acetylserine (NAS), and N-acetylthreonine (NAT). The petition (Pioneer, 2011) shows 

the concentrations of these five acetylated amino acids measured in seed, whole plant, and processed 

product samples derived from 73496 canola. 

Concentrations of NAA and NAG, and in some instances NAGly, NAS, and NAT, are elevated in 

73496 canola, when compared concentrations of these substances in unmodified canola. Quantifiable 

amounts of each N-acetylated amino acid were found in each sample type from 73496 canola except 

refined, bleached, deodorized (RBD) oil (Pioneer, 2011; see Section VIII). 

Under the FFDCA it is the responsibility of food and feed manufacturers to ensure that the 

products they market are safe and properly labeled. Food and feed derived from GE canola must 

be in compliance with all applicable legal and regulatory requirements. GE organisms for food 

and feed may undergo a voluntary consultation process with the FDA prior to release onto the 

market. Although voluntary, until now all applicants who wish to commercialize a GE variety 

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

consultation, a developer who intends to commercialize a bioengineered food, meets with the 

agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding 

the bioengineered food and then submits to FDA a summary of its scientific and regulatory 

assessment of the food. FDA evaluates the submission and responds to the developer by letter.

Under the FFDCA, it is the responsibility of food and feed manufacturers to ensure that the 

products they market are safe and properly labeled. A food safety consultation, which found no 

safety concerns for 73496 canola, was completed by the FDA (BNF No. 129) on May 1, 2012. 

4.5.2 Worker Health

No Alternative: Worker Health

It has been suggested that the importance producers place on worker safety, perceived increased 

simplicity and flexibility of farm management, and decreased risk in production can be partially 

attributed to the high rate of adoption of GE crops (NRC, 2004). Producers and farm workers 

experience reduced exposure to potentially harmful pesticides compared to before adoption of 

GE crops and are also able to spend less time applying pesticides with greater flexibility in 

determining when pesticides are applied. 

Agricultural workers that routinely handle herbicides, including glyphosate, (mixers, loaders, and 

applicators) may be exposed during and after use. Because of low acute toxicity of glyphosate, 

absence of evidence of carcinogenicity and other toxicological concerns, occupational exposure 

data is not required for reregistration (US-EPA, 1993b). However, the glyphosate RED does 

classify some end-use glyphosate products as eye and skin irritants and recommends PPE be 

worn by mixers, loaders, and applicators (US-EPA, 1993b). Because of the potential for skin 

and eye irritation, the EPA has set the restricted entry interval for glyphosate to 12 hours after it 

has been applied. Because of the expected short-term dermal and inhalation exposures of 

occupational handlers and growers, no endpoints were identified by the EPA HED, and as such, 

71
no occupational handler or occupational post-application assessments are required for 

reregistration (US-EPA, 2009c). Current EPA-approved labels for glyphosate include 

precautions and measures to protect human health. When used consistent with the label, 

pesticides present minimal risk to human health and safety. 

Preferred Alternative: Worker Health

Because 73496 canola is another GR-canola option, it would likely only replace other GR

varieties. Therefore, it would not change worker exposure to canola or glyphosate when 

compared to the No-action Alternative.

4.6 Animal Feed

No-action Alternative: Animal Feed

Canola meal has a lower protein content (34-38%) than soybean meal (44-49%) and fewer key 

amino acids (Atkinson et al., 2006; Ash, 2012c). Therefore, canola meal is an economical protein 

source for animals that do not have high energy or lysine requirements (Ash, 2012c). The 

majority of canola meal in the United States is fed to cattle and swine as part of a feed ration. 

Poultry, aquaculture, and specialty animals can also be fed canola meal as a protein source, high 

in fiber content, at low palatability-limit feeding rates (Ash, 2012c). Drawbacks include: its high 

level of sulfur (0.5% -1.3% on a 100% dry-matter basis), so the National Research Council 

recommends that total dietary sulfur not exceed 0.4% on a dry-matter basis. Some producers 

have also noticed that cattle tend to develop scours when fed canola hay or silage as the only 

source of roughage, if the recommended canola hay or silage is less than 50-60% of the 

total feed intake (Atkinson et al., 2006).

Similar to the regulatory control for direct consumption of canola under the FFDCA, it is the 

responsibility of feed manufacturers to ensure that the products they market are safe and properly 

labeled. Feed derived from GE canola must comply with all applicable legal and regulatory 

requirements, which are designed to protect human health. To help ensure compliance, a 

voluntary consultation process with FDA may be implemented before release of GE plants in 

animal feed into the market. 

The majority of the canola cultivated in the U.S. is grown mainly for vegetable oil and animal feed 

(Kandel, 2011). Under the No-action Alternative, canola-based animal feed would be available from 

currently cultivated varieties, including 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.

4.6.2 Preferred Alternative: Animal Feed

As described in section 4.5.1, the GAT4621 protein is unlikely to be toxic to animals. 

Pioneer initiated a consultation process with FDA for 73496 canola on February 25, 2011. 

Based on the assessment Pioneer conducted, FDA stated in its May 1, 2012 letter:

“ food and feed derived from 73496 Canola are not materially 

different in composition, safety, and other relevant parameters 

72
from canola-derived food and feed currently on the market, and 

that the genetically engineered 73496 Canola does not raise 

issues that would require premarket review or approval by FDA. 

Based on the information Pioneer has presented to FDA, we have 

no further questions concerning food and feed derived from 

73496 Canola at this time. However, as you are aware, it is 

Pioneer’s continuing responsibility to ensure that foods marketed 

by the firm are safe, wholesome, and in compliance with all 

applicable legal and regulatory requirements.”

4.7 Socioeconomic Impacts

4.7.1 Domestic production of canola

No-action Alternative: Domestic Economic Environment

The U.S. canola acreage increased between 1990 and 2000. Since then, it has fluctuated between 

0.8 and 1.8M acres. In 2012, canola production acreage exceeded that of all previous years for 

which data are available (Fig. 7). About 87% of U.S. canola production value comes from North 

Dakota. Idaho, Minnesota, Montana, and Oklahoma account for slightly less than 10%, and 

about 1% of the U.S. canola value is produced in Washington and Oregon. Slightly less than 2% 

of the production value is created in all the other canola-producing states (Table 13).

The price of canola varies by region of production. In 2011, the range was $20.00-24.10 per 

hundredweight. In 2009, it was $13.50-19.00 (Table 13). The current trend of increasing 

canola production value may be what is influencing the increase in acres 

planted. 

.

Figure 7: U.S. Canola Acreage: 1991-1012 

Source: (USDA-NASS, 2012b)

0

500,000

1,000,000

1,500,000

2,000,000

19911993199519971999200120032005200720092011

CANOLA ACRES PLANTED 

CANOLA - ACRES PLANTED

73
Table 12: Canola Price/Hundred Weight and Value of U.S Production for 2009-2011 

State 1Price/hundred weight 2Value of Production

5 Years 

% 

Value

2009 2010 2011 2009 2010 2011

Idaho 14.00 18.70 20.00 3,451 6,193 7,770 1.6

Minnesota NA3 20.90 24.10 NA 14,390 9,447 2.2

Montana 13.50 20.00 22.50 1,457 5,917 9,402 1.6

North Dakota 16.10 19.30 23.30 214,774 421,589 297,075 87.4

Oklahoma 19.00 17.30 24.10 9,139 15,501 20,485 4.2

Oregon 17.00 17.60 22.50 1,907 2,458 3,363 0.7

Washington1 NA NA 22.60 NA NA 4,380 0.4

Other U.S. States 18.10 17.80 23.60 8,204 5,505 5,631 1.8

United States 16.20 19.30 23.30 238,932 471,553 357,553

1

U.S. dollars (USD);

2

In thousands of USD; 

3

Data not available

Source: (USDA-NASS, 2012b).

Production costs (conventional tillage, drilled) are similar to wheat and may be estimated at $130 

to $160 per acre, with harvest and marketing costs at $40 to $60 per acre (Boyles et al., 2012). 

Canola total expenses per acre, including both variable and fixed costs, would come to 

approximately $180. Presuming gross returns of $220 per acre, returns to land, capital and 

management would be approximately $40 per acre.

Increasing demand for oilseed along with the increase in price paid for canola may increase 

overall returns per acre for canola. Conversely increases in the cost of inputs such as fuel may 

off-set the potential increase.

The 2007 Census of Agriculture reported that 3,123 farms harvested canola, compared with 

3,831farms in 2002 and 2,892 farms in 1997 (Ash, 2012b). As the number of farms declined 

between 2002 and 2007, the amount of harvested acreage remained about the same. The number 

of large farms over 1,000 acres increased 23% while the number of farms under 100 acres 

declined 33%. This trend in increasing farm size is not specific to canola. 

74
As described in section 2.6.1, some state governments have restrictions on growing canola in 

certain geographic areas. For example, Oregon has adopted a new rule establishing a zone where 

canola cultivation is restricted or prohibited. This rule applies to Brassica spp. (OregonDepartment-of-Agriculture, 2013).

Preferred alternative

Under the preferred alternative, 73496 canola would likely be commercially available to canola 

growers. The availability of 73496 canola would be unlikely to influence the number of acres of 

canola planted. The trend toward increasing prices for canola and other oilseed crops is more 

likely to influence the number of acres planted. As discussed in section 4.2, most canola 

produced in the U.S. is HR. About half of this canola is GR. Assuming that 73496 canola is 

priced competitively with other GE canola products, it is not likely to increase the proportion of 

GR canola planted. Therefore, the impact of the Preferred Alternative on domestic canola 

production will not differ from that of the No-action alternative.

4.7.2 Organic Market for Canola

No-action Alternative

The 2008 Census of Agriculture provided the first data (Table 14) for U.S. organic canola. This 

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

Michigan, New York, and Washington) (USDA-NASS, 2008). The 2012 survey, reported that 

there were only two farms in Iowa and Wisconsin that harvested organic canola (USDA-NASS, 

2012a). To avoid reporting data from individual farms, the only state specific data reported was 

8.5 metric tons harvested in Washington, with a value of $3,560 (Table 14).

From the available data, it appears that there are a limited number of organic canola growers, and 

they are located in areas that do not historically produce large amounts of canola. In the 2008, 

survey the value of organic canola in the U.S. was about $93,000 or 0.03% of the total value of 

the canola crop in the same year. Some commenters expressed concerns that cross-pollination 

between GE and organic varieties will affect the organic certification of growers (see comments 

APHIS-2012-0031-0055, APHIS-2012-0031-0056, APHIS-2012-0031-0058, APHIS-2012-

0031-0062, APHIS-2012-0031-0069). Commenters have also expressed concerns that contracts 

for GE free specialty markets can be difficult to meet if GE plants are grown in the area. (see 

comment APHIS-2012-0031-0070)

Organic certification is process-based. Certifying agents validate the ability of organic 

operations to follow a set of production standards and practices that meet the requirements of the 

Organic Foods Production Act of 1990 (OFPA). This achieved through implementation of the 

NOP regulations established under authority of the OFPA.

These regulations prohibit the use of excluded methods (i.e., “GE organisms”) in organic 

operations. If all aspects of the organic production or handling process were followed correctly, 

then the presence of a detectable residue from a GE organism alone does not constitute a 

violation of this regulation. This policy was established in the NOP Regulation Preamble to the 

Final Rule (FR Vol. 65, No. 246, p. 80556), December 21, 2000. 

75
Table 13: Harvested and Value of Sales from Certified Organic Canola Farms in 2008

CANOLA, EDIBLE 

(POUNDS)

Harvested Value of Sales

Farms Acres Quantity Farms Dollars

United States 

(2008 Survey) 8 232 404,725 8 92,752

Iowa 2 1NA NA 2 NA

Michigan 1 NA NA 1 NA

New York 2 NA NA 2 NA

Washington 3 NA 18,610 3 3,560

United States 

(2012 Survey) 2 NA NA 2 NA

Iowa 1 NA NA 1 NA

Wisconsin 1 NA NA 1 NA

1

NA: Not available

(USDA-NASS, 2008), and 2011 (USDA-NASS, 2012a).

Preferred Alternative

Availability of nonregulated 73496 canola is neither likely to influence the number of growers

of, nor the number of acres planted to organic canola, so the value of organic canola should 

remain stable under the Preferred Alternative. The current commercial canola market is over 

95% GE and the preferred alternative will not change that market share. Therefore, the approval 

of an additional GE variety is not likely to change the likelihood of cross pollination between GE 

and non-GE sexually compatible plants. The approval of the petition is also unlikely to change 

the geographic areas that produce either organic or GE canola.

4.7.3 Trade Economic Environment

No-action Alternative: Trade Economic Environment

Global canola production has increased rapidly during the past 40 years from the sixth to the 

second largest oil crop (second only to soybeans). Total U.S. exports have averaged slightly 

more than 224 thousand metric tons. Error! Reference source not found. shows the changes in 

export quantities between 2007 and 2011.

76
The U.S. exported 150-300 thousand metric tons of canola each year between 2007 and 2011. 

The majority of the canola exported went to Canada where it was processed. U.S. imports of 

canola oil continue to increase steadily from 0.5M metric tons in 2000 to 1.2M metric tons in 

2010. Most foreign sales are to Canadian crushing plants, although shipments to Mexico grew 

rapidly in 2000/01 (USDA-ERS, 2001). The U.S. share of world production remains small, but is 

an increasingly important component of regional economies in the Northern Plains (Ash, 

2012b). Over 90% of imported canola was sent to North Dakota, Minnesota, and Montana. Of 

this, less than 10% was used for seeding purpose and the rest went to crushing plants, primarily 

in North Dakota (U.S Grain Quality Control, 2008; Zollinger et al., 2008; USDA-ESMIS, 2012).

Figure 8: U.S. Exports of Canola 2007-2012

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. Figure 9 shows a comparison of imports needed to offset the 

differential between U.S. production and demand.

Preferred Alternative: Trade Economic Environment

Approving the petition for nonregulated status for 73496 canola is not likely to change either 

U.S. or international canola trade. The event is approved in Canada10, which is where the US 

exports the majority of its canola. Imports and exports are driven by demand for canola oil. 

Most canola varieties planted in both the U.S. and Canada are HR. Pioneer 73469 canola is only 

10

http://active.inspection.gc.ca/scripts/database/pntvcn_submitdb.asp?lang=e&crops=1&company

=all&trait=all&events=all

0

50000

100000

150000

200000

250000

300000

350000

2007 2008 2009 2010 2011

US Exports of Canola 

World

Canada

77

 
expected to replace some of the acres planted with other GR varieties. Based on these 

determinations, APHIS concludes that the impact of selecting the Preferred Alternative will not 

differ significantly from that of those currently associated with the No-action Alternative. 

Figure 9: Canola Seed Quantities in the U.S.

The total domestic production and imported canola seed are shown in millions of pounds. The majority of these 

seeds are crushed for oil. Crushing plants use imported seed to supplement the domestic supply when making canola 

oil. Imports of canola seed constitute from one- third to one-half of the seed crushed for oil. (adapted from table 24 

of (USDA-ERS, 2012a)) 

0

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000

Canola Seed Quantities in US 

Imports

Production

78
5 CUMULATIVE IMPACTS

5.1 Assumptions Used for Cumulative Impacts Analysis

Cumulative effects have been analyzed for each environmental issue assessed in Section 4, 

Environmental Consequences. The cumulative effects 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 for a resource area, then APHIS assumes there can be no cumulative 

impacts. Where it is not possible to quantify impacts, APHIS provides a qualitative assessment 

of potential cumulative impacts. APHIS considered the potential for 73496 canola to extend 

the range of canola production and affect the conversion of land to agricultural purposes. 

Pioneer’s studies demonstrate 73496 canola is similar in its growth habit, agronomic 

properties, disease susceptibility to other nonregulated varieties of GR canola, and other GE 

and non-GE canola (Pioneer, 2011; USDA-APHIS, 2013). This implies that its cultural 

requirements would neither differ from those of other canola nor change the areas in which 

canola is currently cultivated. As presented in Subsection 4.2, Acreage and Area of Canola 

Production, the majority of canola cultivated in the U.S. is herbicide-resistant. If the 

petition is approved, 73496 canola could replace other commercially available GR canola

varieties without requiring cultivation of new, natural lands. As such, land use changes 

associated with approving the petition for nonregulated status to 73496 canola are not 

expected to be any different than those associated with the cultivation of other canola

cultivars. Therefore, although the preferred alternative would allow for new plantings of 

73496 canola to occur anywhere in the U.S., APHIS focused the analysis of cumulative impacts 

on the areas in the U.S. that currently support canola production. 

Potential reasonably foreseeable cumulative effects are analyzed under the assumption that 

farmers have used in the past and would continue to use reasonable, commonly accepted best 

management practices (BMPs) for their chosen system and varieties during agricultural canola

production. APHIS recognizes, however, that not all farmers will use such BMPs. Thus, the 

cumulative impact analysis will also make the assumption that not all farmers would do so. 

Pioneer has indicated it is not necessary to change the use pattern of glyphosate on the GR 73496 

canola variety. Hence, APHIS will use current glyphosate labels as the basis for its potential 

past, present, and reasonably foreseeable impacts from the use of and exposure to glyphosate 

assessment. APHIS assumes growers of 73496 canola will adhere to the EPA-registered uses 

and EPA-approved labels for all pesticides applied to canola. 

According to the petitioner, there is no current demand for stacked canola products. Therefore, 

while 73496 canola could be combined with commercially available HR varieties of canola, it is 

not a reasonably foreseeable future action.

5.2 Past and Present Actions 

In the preceding analysis, the potential impacts from approving the petition for nonregulated

status to 73496 canola were assessed. The potential impacts under the Preferred Alternative for 

all the resource areas analyzed were the same as those described for the No-action Alternative. 

79
The Preferred Alternative is not expected to directly cause a measurable change in agricultural 

acreage or area devoted to conventional or GE-canola cultivation or canola grown for seed in the 

U.S. (see Subsections 4.2.1, Acreage and Area of Canola Production, and 4.2.3, Canola Seed 

Production). The majority of canola grown in the U.S. is GE and HR. Because 73496 canola is 

another GR canola cultivar that is agronomically and compositionally similar to other 

commercially available GR canola cultivars, and approximately 50% U.S. canola is glyphosateresistant, it is expected 73496 canola would replace other similar cultivars without expanding the 

acreage or area of canola production. As discussed in section 4.2, canola acreage may expand 

over time, but that expansion is driven by canola demand. There are also no anticipated changes 

to the availability of GE and non-GE canola varieties on the market are anticipated.

Based upon recent trends, adding GE varieties to the market is not related to the ability of 

organic production systems to maintain their market share (see Subsection 4.7.2, Organic Canola

Production). As described above, the majority of canola is GE and HR. Since 1994, 7 GE 

canola events or lines have been determined by APHIS to be no longer subject to the regulatory 

requirements of 7 CFR part 340 or the plant pest provisions of the PPA (USDA-APHIS, 2012). 

U.S. organic canola production acreage is very likely less than 500 acres. Because there are so 

few growers, more precise number is not publically available (see Table 14). Availability of 

another GE glyphosate-resistant canola variety, such as 73496 canola, under the Preferred 

Alternative, is not expected to impact the organic production of canola any differently than other 

GE varieties currently being grown. 

Approving the petition for a determination of nonregulated status to 73496 canola is not expected 

to result in changes to current canola cropping practices. Studies conducted by Pioneer

demonstrate that, in terms of agronomic characteristics and cultivation practices, 73496 canola

is similar to other canola varieties currently grown (Pioneer, 2011; USDA-APHIS, 2013). 

Consequently, no changes to current canola cropping practices such as tillage, crop rotation, or 

agricultural inputs associated with the adoption of 73496 canola are expected (see Subsection 

4.2.2, Agronomic Practices). 

Approving the petition for a determination of nonregulated status to 73496 canola would have 

the same impacts to water, soil, air quality, and climate change as that of nonregulated, GRcanola varieties presently available. Agronomic practices that have the potential to impact soil, 

water and air quality, and climate change such as tillage, agricultural inputs (fertilizers and 

pesticides), and irrigation would not change because 73496 canola is agronomically similar to 

other GR canola and other GE and non-GE canola. Other practices that benefit these resources, 

such as contouring, use of cover crops to limit the time soil is exposed to wind and rain, crop 

rotation, and windbreaks would also be the same. Because of its similarity to other nonregulated

varieties of GR canola and the fact that half of the cultivated canola in the U.S. is GR, adoption 

of 73496 canola is expected to replace other similar cultivars without changing the acreage or 

area of canola production that could impact water, soil, air quality, and climate change. 

The impacts of the Preferred Alternative to animal and plants communities, microorganisms, and 

biodiversity would be no different than that experienced under the No-action Alternative. 73496 

canola is both agronomically and compositionally similar to other nonregulated, GR canola. 

Thus, it would not require any different agronomic practices to cultivate, and does not represent 

a safety or increased weediness risk that is any different from other currently available GR

80
canola. Availability of 73496 canola would not impact the development of GR weeds or the 

trend to broaden weed management tactics to affect control over HR weeds, as it is expected to 

replace other GR cultivars without changing the application rates of glyphosate. 

The potential impacts from the use of herbicides under the Preferred Alternative would be the 

same as those of the No-action Alternative. The methods of application and use rate for 

herbicides to be applied to 73496 canola would not change from those already approved for use 

on other nonregulated, GR canola cultivars. The total amount of the mix of herbicides that could 

be applied to 73496 canola would be limited by the authorized EPA-registered uses and the total 

application amount allowed by law. Glyphosate and other pesticides are registered by the EPA 

under FIFRA and are reviewed and reregistered every 15 years to assess potential toxicity and

environmental impact. In order to be registered for use, a pesticide must be able to be used 

without unreasonable risks to people or the environment. Pesticide residue tolerances for 

glyphosate and other herbicides and pesticides are listed in 40 CFR §180.364 and include 

acceptable concentrations for canola grain and forage. In addition, the safety precautions and 

EPA-labeled instructions for the application of pesticides would not change under the Preferred 

Alternative, ensuring continued human health and worker safety. 

There are no differences in the potential for gene flow and weediness under the Preferred Action 

Alternative. Outcrossing and weediness are addressed in the PPRA (USDA-APHIS, 2013)

73496 canola is similar to other GR canola varieties. The risk of gene flow and weediness of 

73496 canola is no greater than that of other nonregulated, GR canola varieties.

Food and feed derived from GE canola must be in compliance with all applicable legal and 

regulatory requirements and may undergo a voluntary consultation process with the FDA prior to 

release onto the market to identify and discuss relevant safety, nutritional, or other regulatory 

issues regarding the bioengineered food. 73496 canola is expected to have no toxic effect to 

human health or livestock. Pioneer submitted a safety and nutritional assessment and food safety 

consultation of 73496 canola was completed by the FDA (BNF No. 129) on May 1, 2012. The 

GAT protein is also expressed in soy and corn (see BNF 108 and 111). No change in food and 

feed safety is expected to occur under the Preferred Alternative.

Since 73496 canola is GR, it would directly compete with the market share of other GR canola

varieties. Trends indicate that the amount of GR canola planted has remained relatively 

consistent and is not predicted to change (see figure 4 and 5). Based on its similarity to other 

nonregulated canola cultivars, 73496 canola would likely replace other GR canola cultivars 

without impacting canola acreage or production area that may affect domestic markets. Since 

73496 canola is agronomically and compositionally similar to other commercially available 

canola, there also would be no changes to agronomic inputs or practices that may impact on-farm 

costs for canola producers or the domestic economic environment, including the organic canola

market. As noted above, it is unlikely that 73496 canola would impact the development or 

treatment of HR weeds, their associated costs in crop losses or methods used to effect control. 

No changes to the domestic economic environment are expected to occur under the Preferred 

Alternative.

Similarly, 73496 canola is not expected to affect the Seed, feed, and food trade are also unlikely 

to be affected by 73496 canola any differently than other nonregulated GR-canola varieties. 

81
Other countries already have access to GR canola varieties and are significant export competitors 

to U.S. canola trade. 73496 canola is compositionally and agronomically similar to other GR

cultivars in the marketplace. In summary, the potential cumulative effects regarding past and 

present actions combined with the Preferred Alternative have been analyzed, and no changes 

from the current baseline under the No-action Alternative would occur. 

5.3 Reasonably Foreseeable Actions

APHIS is also considering a petition for nonregulated status of a different GR canola variety, 

MON 88302. If APHIS were also to approve that petition, there would potentially be an 

additional GR canola variety marketed to growers. These two new varieties would likely 

compete in the marketplace for a share of the GR canola market. How much of the market each 

of these new varieties capture depends on factors such as the characteristics of the commercial 

varieties with which these events are bred, grower references, and price. Therefore the relative 

contribution of either of these events to total future canola production cannot be known. 

However, neither is likely to shift the use away from other varieties that are resistant to 

herbicides with different modes of action, if growers are choosing those varieties for the 

resistance characteristic. If APHIS does not approve the petition for MON 88302, then these two 

events would not compete in the marketplace.

In 2012 the canola acreage planted was 65% greater than the canola acreage planted in the 

previous year. In fact it was the most acreage planted with canola in the NASS database. 

Increased demand for oilseed (USDA-ERS, 2012b) and high canola prices (Ash, 2012a) may 

have influenced the expanded acreage.

There is also a growing interest in winter canola production in areas where winter wheat is 

grown. For example, in Oklahoma the acres planted to canola have increased almost 4-fold over 

the past four years (USDA-NASS, 2013). Canola is recommended as a rotation crop with winter 

wheat because the weed management options are different in the two crops (Boyles, 2009). 

Currently there are some varieties of winter canola that are resistant to glyphosate (Boyles, No 

date). APHIS was not able to identify information for the percent of winter canola acres planted 

with GR varieties. If 73496 canola is bred into winter canola varieties, it may be adopted in this 

growing market. Because the use of glyphosate on 73496 canola would not change compared to 

the use on currently available varieties, there would be no change in the effects from planting 

73496 canola, when compared to varieties available under the No-action Alternative.

5.4 Cumulative Impacts Summary

In summary, the potential for impacts of 73496 canola would not result in any changes to the 

resources areas when compared to the No-action Alternative. No cumulative effects are 

expected from approving the petition for nonregulated status for 73496 canola, when taken in 

consideration with related activities, including past, present, and reasonably foreseeable future 

actions. 

82
Figure 10: Oklahoma Canola Acres Planted from 2009-2012

0

50000000

100000000

150000000

200000000

250000000

300000000

350000000

400000000

450000000

2009

2010

2011

83
6 THREATENED AND ENDANGERED SPECIES

Congress passed the Endangered Species Act (ESA) of 1973, as amended, to prevent extinctions 

facing many species of fish, wildlife, and plants. The purpose of the ESA is to preserve critical 

elements of America’s natural history heritage by conserving threatened and endangered species 

(TES), ecosystems they require for survival. The US-FWS works in cooperation with the 

NMFS, other Federal, State, and local agencies, Tribes, NGOs (non-government organizations), 

and private citizens to implement the ESA. Before a plant or animal species can receive the 

protection provided by the ESA, it must first be added to the Federal list of threatened and 

endangered wildlife and plants.

A species is added to the list when it is determined by the US-FWS/NMFS to be endangered or 

threatened because of any of the following factors:

• Present or threatened destruction, modification, or curtailment of its habitat or range;

• Overutilization for commercial, recreational, scientific, or educational purposes;

• Disease or predation;

• Inadequacy of existing regulatory mechanisms;

• Other natural or manmade factors affecting its survival.

Once listed in accordance with the ESA, protective measures apply to the species and its habitat. 

These measures include protection from adverse effects caused by Federal actions.

Section 7 (a)(2) of the ESA requires Federal agencies to consult with the US-FWS and/or the 

NMFS to ensure that any action they authorize, fund, or carry out is unlikely to jeopardize the 

continued existence of a listed species or result in the destruction or adverse modification of its 

designated critical habitat. It is the responsibility of the Federal implementing agency to assess 

effects and initiate a consultation with the US-FWS and/or NMFS, if it determines that a 

proposed action may affect listed species or critical habitat. To facilitate its consultation process, 

USDA-APHIS met with the US-FWS from 1999 to 2003 to discuss factors relevant to the 

APHIS regulatory authority and effects analysis for petitions for nonregulated status, and 

developed a process for conducting an effects analysis and determination consistent with the 

PPA of 2000 (Title IV of Public Law 106-224). This process is described in a decision tree 

document (see Appendix A) APHIS uses this process to help fulfill its obligations and 

responsibilities under Section 7 of the ESA for biotechnology regulatory actions. 

The APHIS regulatory authority over GE organisms under the PPA is limited to those that are 

actual or suspected plant pests, or those that cannot adequately be assessed for plant pest risk 

potential consistent with 7 CFR §340.1 because of insufficient information. USDA-APHIS does 

not have authority to regulate the use of any herbicide, including glyphosate. After completing a 

PPRA, if USDA-APHIS determines that Pioneer 73496 Canola does not pose a plant pest risk, 

then the Agency would no longer have legal justification to regulate it under the plant pest 

provisions of the PPA described in 7 CFR §340. Therefore, APHIS would have to make a 

determination that the article is no longer regulated. As part of its EA analysis, the Agency 

84
analyzed the potential impacts of Pioneer 73496 Canola on the environment, including those that 

might affect TES and critical habitat. As part of this process, APHIS thoroughly reviewed the 

GE product information and data related to 73496 canola.

As described in Appendix A for each transgene/transgenic plant, USDA-APHIS analyzes the 

following: 

• Biology and taxonomy of the crop plant and its sexually compatible relatives;

• Each transgene to characterize its structure and function, and the nature of the 

organism from which it was obtained;

• Location(s) of the new transgene and the quality and quantity of products (if any) 

derived from it;

• Agronomic performance of the plant including its disease and pest susceptibilities, 

weediness potential, and agronomic and environmental impact;

• Concentrations of any known plant toxins, if applicable; 

• Sexual compatibility of the transgenic plant with any plant TES or plants serving as 

hosts of TES;

• Any other information relevant to the potential for an organism to pose a plant pest 

risk.

Consistent with this review process, APHIS has evaluated the potential effects that approval of a 

petition for nonregulated status for Pioneer 73496 Canola might have on Federally-listed and 

proposed TES, as well as designated and proposed critical habitat. Based upon the scope of this 

EA and production areas identified in the Affected Environment section of this EA, APHIS 

obtained and reviewed the USFWS listed and proposed TES for each state where canola is 

grown commercially using the USFWS Environmental Conservation Online System11 Prior to 

obtaining this list, APHIS also considered the potential for Pioneer 73496 Canola to extend the 

range of canola production, and also the possibility that it would expand agricultural production 

into previously uncultivated natural habitat. 

Comparison studies demonstrate that 73496 canola is similar in its growth habit, agronomic 

properties, disease susceptibility, and composition to non-transgenic control group cultivars, 

other transgenic varieties of GR canola that are not regulated, and other GE and non-GE canola 

(Pioneer, 2011). Since Pioneer 73496 Canola will only replace other canola varieties currently 

cultivated, its introduction will not promote an expansion of canola acreage or result in extension 

of canola production into previously uncultivated natural habitat. Therefore, the issues discussed 

herein focus on the potential environmental consequences of approval of the petition for 

11 ECOS; as accessed 3/18/2013 at http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrence.jspUS-FWS, 

Species Reports - Listings and Occurrences for Each State

85

 
nonregulated status for Pioneer 73496 Canola on TES and critical habitat in the areas where 

canola is currently grown.

APHIS focused its ESA effects analysis on the implications of exposure to the GAT 4621 protein 

in Pioneer 73496 Canola, and the interaction between TES and the Pioneer 73496 Canola plant, 

including potential for sexual compatibility and ability to serve as a host for a TES. However, in 

furtherance of NEPA, APHIS also considered the potential impacts of the use of glyphosate 

herbicides to non-target organisms and the natural environment. 

6.1 Potential Effects of Pioneer 73496 Canola on TES and Critical Habitat

USDA-APHIS, as described below, has evaluated the potential effects that approval of a petition 

for nonregulated status of Pioneer 73496 Canola might have on Federally-listed TES and species 

proposed for listing, as well as designated critical habitat and habitat proposed for designation.

A review of the listed and proposed TES of plants indicates that none of them are classified in 

the same genus as that of the mustard varieties from which canola is derived (i.e., Brassica rapa, 

B. napa, B. campestris or B. juncea). The review also indicates that there are no listed or 

proposed TES of plants that are sexually compatible with Brassica spp., so transgenic canola 

will not cross-pollinate with any plant TES. Therefore, there is no evidence indicating that 

Pioneer 73496 Canola would directly affect any plant TES.

Pioneer has provided data in its petition indicating that compositionally, 73496 canola is 

equivalent to other canola varieties currently grown. There are no toxins or allergens associated 

with this plant. The GAT 4621 protein is present in other crops proposed previously for 

nonregulated status, and subsequently evaluated by APHIS. There is no expectation that the 

protein or the plant will have any effect on TES of animals that may be exposed to Pioneer 

73496 Canola. 

In its PPRA, APHIS also evaluated 73496 canola with particular emphasis on its weediness 

potential (USDA-APHIS, 2013), and determined what effect, if any, that could have on 

designated critical habitat or habitat proposed for designation. Outcrossing and weediness are 

also addressed in the PPRA (USDA-APHIS, 2013), which demonstrated that 73496 canola is 

similar to other GR canola varieties. The risk of gene flow and weediness of 73496 canola is no 

greater than that of other nonregulated, GR-canola varieties, nor is there any significant potential 

for GE canola to become invasive.

In conclusion, canola is neither sexually compatible with, nor does it serve as a host species for 

any listed species or species proposed for listing. Exposure to the Pioneer 73496 Canola plant 

and the GAT 4621 protein will not affect any species, and Pioneer 73496 Canola will not 

naturalize in critical habitat. APHIS has concluded that approval of a petition for nonregulated

status for Pioneer 73496 Canola, and its corresponding environmental release, will have no effect 

on listed species or species proposed for listing, and will not affect designated habitat or habitat 

proposed for designation. Therefore, consultation with USFWS or NMFS under Section 7(a)(2) 

of the ESA is not required.

86
6.2 Potential Impacts of Glyphosate Use on TES and Critical Habitat

To help clarify our ESA and NEPA obligations, APHIS met with USFWS officials on June 15, 

2011 to discuss whether APHIS has any obligations under the ESA to analyze the impacts of 

herbicide use associated with all GE crops on TES. As a result of these joint discussions, the 

USFWS and APHIS have agreed that it is not necessary for APHIS to perform an ESA effects 

analysis on herbicide use associated either with Pioneer 73496 Canola or other currently planted 

GE crops.

APHIS has no statutory authority to authorize or regulate the use of glyphosate, or any other 

herbicide, by canola growers. Under 7 CFR 340, APHIS only has the authority to regulate 

Pioneer 73496 Canola or any GE organism, if the agency believes it may pose a plant pest risk or 

if the agency cannot adequately assess the organism for plant pest risk potential consistent with 7 

CFR §340.1 because of insufficient information. APHIS has no regulatory jurisdiction over any 

other risks associated with GE organisms, including risks resulting from the use of herbicides or 

other pesticides on those organisms. Nevertheless, APHIS is aware that there may be potential 

environmental impacts resulting from the use of glyphosate on Pioneer 73496 Canola, including 

potential impacts on TES and critical habitat, based on assessments provided by the EPA and in 

peer reviewed scientific literature.

Under the Preferred Alternative, approval of a petition for nonregulated status for Pioneer 73496 

Canola does not change the EPA-registered uses of glyphosate. As noted in the previous section, 

nearly all (i.e., 85-90%) of canola grown in the US is HT (Johnson et al., 2007). Approval of 

nonregulated status for 73496 canola would only result in the addition of an alternative GR 

variety that could replace GR varieties used currently. Therefore, approval of a petition for 

nonregulated status for Pioneer 73496 Canola would not be expected to increase the amount of 

glyphosate that is currently used in canola production. Based on these considerations, APHIS 

has concluded that a determination of nonregulated status for Pioneer 73496 Canola, would not 

result in any changes in effects of glyphosate on TES or their designated critical habitats. 

General considerations relevant to the impact of glyphosate on TES have been reviewed by EPA, 

which has developed the Endangered Species Protection Program (ESPP). This program 

identifies pesticides that may cause adverse impacts to TES, and mitigation measures that 

address these impacts. To analyze the potential of registered pesticide uses that affect any 

particular species, the EPA assesses toxicity and exposure data developed for REDs 

(Reregistration Eligibility Decisions). A determination that there is a likelihood of a potential 

impact on a TES may result in limiting registered uses of a pesticide, other measures to mitigate 

any potential impact, and/or consultations with the USFWS and/or the NMFS.

Glyphosate is currently under reregistration review, which is scheduled to be complete in 2015

(US-EPA, 2009b). As part of the review, the EPA will conduct a risk assessment to support a 

complete endangered species determination (US-EPA, 2009c). 

Assessments of the toxicity of glyphosate on animal species indicate low risk to animals, but 

high risk to plants. Glyphosate is moderately toxic to mammals, less than or slightly toxic to 

birds, and virtually non-toxic to fish, invertebrates, and honeybees (US-EPA, 1993a). Impacts to 

TES and/or their habitats may result from non-target exposure from pesticide drift, runoff, 

volatilization, adsorption into soils, leaching, and cleaning and disposal of herbicide dispensing 

87
equipment. These impacts are mitigated by the requirements for the use of each product that 

appear on the EPA registration label. Since past ecological assessments indicated possible 

exposure risk to non-target terrestrial and aquatic plants outside treated fields, a spray drift buffer 

zone analysis is planned for the glyphosate reregistration review currently underway (US-EPA, 

2009c). EPA will implement any mitigations necessary to eliminate the potential of glyphosate 

to impact terrestrial or aquatic non-target plant species, including TES, through modifications to 

current label requirements on each glyphosate product(US-EPA, 2009c). 

The surfactant polyethoxylated tallow amine (POEA) is included in some glyphosate product 

formulations. POEA is more toxic to aquatic organisms than glyphosate itself (US-EPA, 2009c). 

Therefore, EPA will identify and consider formulations containing POEA in its ecological and 

endangered species risk assessments. Under the new requirements of 40 CFR Part 158, studies 

to determine acute toxicity of POEA to estuarine and marine mollusks, invertebrates, and fish 

species will be accomplished for inclusion in the current registration review.

In the ecological risk assessment for the current reregistration process, the EPA has reviewed 

whether the approved uses of glyphosate represent a “no effect” or “may affect” impact on TES, 

their designated critical habitats (US-EPA, 2009c). The EPA has consulted with the USFWS and 

NMFS on the effects of glyphosate on certain TES and designated critical habitat (US-EPA, 

1993b; US-EPA, 2004; US-EPA, 2008). Throughout the reregistration process, EPA will consult 

with USFWS and NMFS as necessary to meet their obligations under section 7 (a)(2) of the ESA 

to ensure that uses of glyphosate that are consistent with label regulations will not affect TES.

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7 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND 

TREATIES RELATING TO ENVIRONMENTAL IMPACTS

7.1 Executive Orders with Domestic Implications

The following executive orders require consideration of the potential impacts of the Federal 

action to various segments of the population.

• Executive Order (EO) 12898 (US-NARA, 2010), "Federal Actions to Address 

Environmental Justice in Minority Populations and Low-Income Populations," requires 

Federal agencies to conduct their programs, policies, and activities that substantially affect 

human health or the environment in a manner so as not to exclude persons and populations 

from participation in or benefiting from such programs. It also enforces existing statutes to 

prevent minority and low-income communities from being subjected to disproportionately 

high and adverse human health or environmental effects. 

• EO 13045, “Protection of Children from Environmental Health Risks and Safety Risks,”

acknowledges that children may suffer disproportionately from environmental health and 

safety risks because of their developmental stage, greater metabolic activity levels, and 

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

consistent with the agency’s mission) requires each Federal agency to identify, assess, and 

address environmental health risks and safety risks that may disproportionately affect 

children.

The No-action and Preferred Alternatives were analyzed with respect to EO 12898 and EO 

13045. Neither alternative is expected to have a disproportionate adverse effect on minorities, 

low-income populations, or children. Available mammalian toxicity data associated with the 

GAT 4621protein establish the safety of Pioneer 73496 Canola and its products to humans, 

including minorities, low-income populations, and children who might be exposed to them 

through agricultural production and/or processing. No additional safety precautions would need 

to be taken with nonregulated 73496 canola.

Human toxicity has also been thoroughly evaluated by the EPA in its development of pesticide 

labels for glyphosate (US-EPA, 1993b; US-EPA, 2009b; US-EPA, 2009c). Pesticide labels 

include use precautions and restrictions intended to protect workers and their families from 

exposures. APHIS assumes that growers will adhere to herbicide use precautions and 

restrictions. As discussed in Subsection 4.5, Human Health, the potential use of glyphosate on 

73496 canola at the proposed application rates would be no more than that currently approved 

for other nonregulated GR canola and found by the EPA not to have adverse impacts to human 

health when used in accordance with label instructions. It is expected that the EPA and ERS 

would monitor the use of 73496 canola to determine impacts on agricultural practices, such as 

chemical use, as they have done previously for HR products.

Based on these factors, an extension of a determination of nonregulated status to 73496 canola is 

not expected to have a disproportionate adverse effect on minorities, low-income populations, or 

children.

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The following executive order addresses Federal responsibilities regarding the introduction and 

effects of invasive species:

EO 1311 (US-NARA, 2010), “Invasive Species,” states that Federal agencies take action 

to prevent the introduction of invasive species, to provide for their control, and to 

minimize the economic, ecological, and human health impacts that invasive species 

cause. 

Canola is not listed in the U.S. as a noxious weed species by the Federal government (USDANRCS, 2010), nor is it listed as an invasive species by major invasive plant data bases 

(University of Georgia and USDOI-NPS, 2009; GRN, 2012). While pollen-mediated gene 

transfer can occur, there are no differences in the potential for gene flow and weediness. 

Outcrossing and weediness are addressed in the PPRA (USDA-APHIS, 2013) and 73496 canola 

is similar to other GR-canola varieties. The risk of gene flow and weediness of 73496 canola is 

no greater than that of other nonregulated, GR canola varieties.

The following executive order requires the protection of migratory bird populations:

EO 13186 (US-NARA, 2010), “Responsibilities of Federal Agencies to Protect 

Migratory Birds,” states that federal agencies taking actions that have, or are likely to 

have, a measurable negative effect on migratory bird populations are directed to develop 

and implement, within two years, a Memorandum of Understanding (MOU) with the Fish 

and Wildlife Service that shall promote the conservation of migratory bird populations. 

The environmental effects associated with glyphosate are summarized in the EPA RED 

for the herbicide (US-EPA, 1993b). Testing indicates that ecological toxicity of 

glyphosate is no more than slightly toxic to birds and does not exceed the agency’s LOC 

(US-EPA, 1993b). However, in accordance with new requirements under 40 CFR part 

158, acute avian oral toxicity data for a passerine species (perching birds) is required for 

the current glyphosate registration review. Based on these factors, it is unlikely that a 

determination of nonregulated status for GR 73496 canola would have a negative effect on 

migratory bird populations because its introduction would not alter current glyphosate-use 

patterns associated with the production of canola in the U.S.

7.2 International Implications

EO 12114 (US-NARA, 2010), “Environmental Effects Abroad of Major Federal Actions”

requires federal officials to take into consideration any potential environmental effects outside 

the U.S., its territories, and possessions that result from actions being taken. 

APHIS has given this EO careful consideration and does not expect a significant environmental 

impact outside the U.S. in the event of a determination of nonregulated status of 73496 canola. 

All existing national and international regulatory authorities and phytosanitary regimes that 

currently apply to introductions of new canola cultivars internationally apply equally to those 

covered by an APHIS determination of nonregulated status under 7 CFR part 340. 

Any international trade of 73496 canola subsequent to a determination of nonregulated status of 

the product would be fully subject to national phytosanitary requirements and be in accordance 

90
with phytosanitary standards developed under the International Plant Protection Convention

(IPPC, 2010). The purpose of the IPPC “is to secure a common and effective action to prevent 

the spread and introduction of pests of plants and plant products and to promote appropriate 

measures for their control” (IPPC, 2010). The protection it affords extends to natural flora and 

plant products and includes both direct and indirect damage by pests, including weeds. 

The IPPC establishes a standard for the reciprocal acceptance of phytosanitary certification 

among the nations that have signed or acceded to the Convention (172 countries as of March 

2010). In April 2004, a standard for PRA of living modified organisms (LMOs) was adopted at 

a meeting of the governing body of the IPPC as a supplement to an existing standard, 

International Standard for Phytosanitary Measures No. 11 (ISPM-11, Pest Risk Analysis for 

Quarantine Pests). The standard acknowledges that all LMOs will not present a pest risk and 

that a determination needs to be made early in the PRA for importation as to whether the LMO 

poses a potential pest risk resulting from the genetic modification. APHIS pest risk assessment 

procedures for GE organisms are consistent with the guidance developed under the IPPC. In 

addition, issues that may relate to commercialization and transboundary movement of particular 

agricultural commodities produced through biotechnology are being addressed in other 

international forums and through national regulations.

The Cartagena Protocol on Biosafety is a treaty under the United Nations Convention on 

Biological Diversity CBD) that established a framework for the safe transboundary movement, 

with respect to the environment and biodiversity, of LMOs, which include those modified 

through biotechnology. The Protocol came into force on September 11, 2003, and 160 countries 

are Parties to it as of December 2010 (CBD, 2010). Although the U.S. is not a party to the CBD, 

and thus not a party to the Cartagena Protocol on Biosafety, U.S. exporters will still need to 

comply with those regulations that importing countries which are Parties to the Protocol have 

promulgated to comply with their obligations. The first intentional transboundary movement of 

LMOs intended for environmental release (field trials or commercial planting) will require 

consent from the importing country under an advanced informed agreement (AIA) provision, 

which includes a requirement for a risk assessment consistent with Annex III of the Protocol and 

the required documentation.

LMOs imported for food, feed, or processing (FFP) are exempt from the AIA procedure, and are 

covered under Article 11 and Annex II of the Protocol. Under Article 11, Parties must post 

decisions to the Biosafety Clearinghouse database on domestic use of LMOs for FFP that may be 

subject to transboundary movement. To facilitate compliance with obligations to this protocol, 

the U.S. Government has developed a website that provides the status of all regulatory reviews 

completed for different uses of bioengineered products (NBII, 2010). These data will be 

available to the Biosafety Clearinghouse. 

APHIS continues to work toward harmonization of biosafety and biotechnology consensus 

documents, guidelines, and regulations, including within the North American Plant Protection 

Organization (NAPPO), which includes Mexico, Canada, and the U.S., and within the 

Organization for Economic Cooperation and Development (OECD). NAPPO has completed 

three modules of the Regional Standards for Phytosanitary Measures (RSPM) No. 14, 

Importation and Release into the Environment of Transgenic Plants in NAPPO Member 

Countries (NAPPO, 2009).

91
APHIS also participates in the North American Biotechnology Initiative (NABI), a forum for 

information exchange and cooperation on agricultural biotechnology issues for the U.S., Mexico, 

and Canada. In addition, bilateral discussions on biotechnology regulatory issues are held 

regularly with other countries including Argentina, Brazil, Japan, China, and Korea.

7.3 Compliance with Clean Water Act and Clean Air Act

This EA evaluated the potential changes in canola production associated with approving the 

petition for a determination of nonregulated status to 73496 canola (see Subsection, 4.2, 

Agricultural Production of Canola) and determined that the cultivation of 73496 canola would 

not lead to the increase in, or expand the area of, canola production that could impact water 

resources or air quality any differently than currently cultivated canola varieties. The herbicide 

resistance conferred by the genetic modification of 73496 canola is not expected to result in any 

changes in water usage for cultivation compared to current canola production. As discussed in 

Subsections 4.3.1, Water Resources, and 4.3.2, Air Quality, there are no expected significant 

negative impacts to water resources or air quality from potential use of glyphosate or other 

pesticides associated with 73496 canola production. Based on these analyses, APHIS concludes 

that an extension of a determination of nonregulated status to73496 canola would comply with 

the CWA and the CAA.

7.4 Impacts on Unique Characteristics of Geographic Areas

Approving the petition for a determination of nonregulated status to 73496 canola is not expected 

to impact unique characteristics of geographic areas such as parklands, prime farmlands, 

wetlands, wild and scenic areas, or ecologically critical areas.

Pioneer has presented results of agronomic field trials for 73496 canola that demonstrate there 

are no differences in agronomic practices, between 73496 canola and currently available GRcanola varieties. The common agricultural practices that would be carried out in the cultivation 

of 73496 canola are not expected to deviate from current practices, including the use of EPAregistered pesticides. The product is expected to be cultivated by growers on agricultural land 

currently suitable for production of canola, and is not anticipated to expand the cultivation of 

canola to new, natural areas. 

The Preferred Alternative for 73496 canola does not propose major ground disturbances or new 

physical destruction or damage to property, or any alterations of property, wildlife habitat, or 

landscapes. Likewise, no prescribed sale, lease, or transfer of ownership of any property is 

expected as a direct result of a determination of nonregulated status for 73496 canola. This 

action would not convert land use to nonagricultural use and, therefore, would have no adverse 

impact on prime farmland. 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. The Applicant’s adherence to EPA-label-use 

restrictions for all pesticides is expected to mitigate potential impacts to the human environment. 

With regard to pesticide use, approving the petition for a determination of nonregulated status for

73496 canola is not likely to result in changes to the use of glyphosate on canola, including 

92
application timing and rates and annual maximum allowable applications. APHIS assumes that 

the grower will closely adhere to EPA-label-use restrictions for glyphosate. 

Glyphosate was assessed by the EPA in 1993 and is currently under reregistration review 

scheduled for completion in 2015 (US-EPA, 2009a). Potential impacts to unique geographic 

areas have been considered by the EPA in its evaluation of glyphosate. In 1993, the EPA 

completed a reregistration analysis for glyphosate, which considered human health risk and 

ecological risks associated with potential exposure to glyphosate in multiple pathways (US-EPA, 

1993b). 

As a result of court orders and settlements, an endangered species assessment evaluating the 

potential impacts of the use of glyphosate on the federally threatened CRLF is underway (USEPA, 2009b). The EPA has requested initiation of formal consultation with the USFWS under 

Section 7 of the ESA to address the potential effects of glyphosate on the CRLF (US-EPA, 

2009b). The EPA’s formal consultation request for the CRLF was based on the potential for 

direct and indirect effects due to decreases in prey items, as well as potential impacts to habitat 

(See Section 6, Threatened and Endangered Species).

In 2004, the EPA made a “not likely to adversely affect” determination from the use of 

glyphosate on 11 ESUs of salmon and steelhead in California and an ESU of salmon in southern 

Oregon (US-EPA, 2004) (see Section 6, Threatened and Endangered Species). Formal 

consultation with the NMFS was initiated by EPA on October 12, 2004 to fulfill a Consent 

Decree entered into between EPA and the Californians’ for Alternatives to Toxics related to the 

potential effects of various pesticides used on plants and certain threatened and endangered 

salmon or steelhead species. While this consultation is ongoing, the EPA has allowed glyphosate 

to remain on the market, and it is approved for continued use in accordance with all label 

requirements. Submittals to this analysis can be found at the Regulations.gov website under 

docket designation EPA-HQ-OPP-2009-0361. 

EPA plans to conduct a comprehensive ecological risk assessment, including an endangered 

species assessment, for all uses of glyphosate and its salts (US-EPA, 2009b). Assessments to 

determine impacts on unique geographic areas include:

• An ecological risk assessment to determine whether the use of glyphosate has “no effect” 

or “may affect” federally listed TES or their designated critical habitat; 

• A spray drift buffer zone analysis to evaluate potential exposure reductions to non-target 

aquatic and terrestrial plants.

The information gathered during the ecological and endangered species risk assessment will be 

used by the EPA to make the registration review decision.

Based on these findings, including the assumption that label use restrictions are in place to 

protect unique geographic areas and that those label use restrictions are adhered to, approving the 

petition for a determination of nonregulated status to 73496 canola is not expected to impact 

unique characteristics of geographic areas such as park lands, prime farm lands, wetlands, wild 

and scenic areas, or ecologically critical areas. 

93
7.5 National Historic Preservation Act (NHPA) of 1966 as Amended 

The NHPA of 1966 and its implementing regulations (36 CFR 800) require Federal agencies to: 

1) determine whether activities they propose constitute "undertakings" that have the potential to 

cause effects on historic properties; 2) if so, to evaluate the effects of such undertakings on such 

historic resources and consult with the Advisory Council on Historic Preservation (i.e., State 

Historic Preservation Office, Tribal Historic Preservation Officers), as appropriate. 

The APHIS proposed action, a determination of nonregulated status of 73496 canola is not 

expected to adversely impact cultural resources on tribal properties. Any farming activity that 

may be taken by farmers on tribal lands would only be conducted at the tribe’s request. Thus, 

the tribes would have control over any potential conflict with cultural resources on tribal 

properties.

The APHIS Preferred Alternative would neither impact districts, sites, highways, structures, or 

objects listed in or eligible for listing in the National Register of Historic Places, nor would it 

likely cause any loss or destruction of significant scientific, cultural, or historical resources. 

This action is limited to a determination of nonregulated status of 73496 canola. 

The APHIS proposed action is not an undertaking that may directly or indirectly cause alteration 

in the character or use of historic properties protected under the NHPA. In general, common 

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

atmospheric, or noise elements to areas in which they are used that could result in effects on the 

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

use and enjoyment of a historic property during the operation of tractors and other mechanical 

equipment close to such sites. A built-in mitigating factor for this issue is that virtually all of the 

methods involved would only have temporary effects on the audible nature of a site and can be 

ended at any time to restore the audible qualities of such sites to their original condition with no 

further adverse effects. These cultivation practices are already being conducted throughout the 

canola production regions. The cultivation of 73496 canola is not expected to change any of 

these agronomic practices that would result in an adverse impact under the NHPA.

94
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9 LIST OF PREPARERS

USDA APHIS Biotechnology Regulatory Service

Joseph Vorgetts, Ph.D., Senior Environmental Protection Specialist

Adam Tulu, Ph.D., Environmental Protection Specialist 

Rebecca Stankiewicz Gabel, Ph.D., Branch Chief, Biotechnology Environmental Analysis 

Branch Environmental Risk Analysis Program 

113 
APPENDIX A. APHIS THREATENED AND ENDANGERED SPECIES 

DECISION TREE FOR U.S. FISH AND WILDLIFE SERVICE 

CONSULTATIONS

Decision Tree on Whether Section 7 Consultation with the U.S. Fish and Wildlife Service 

(USFWS) is Triggered for Petitions of Transgenic Plants

This decision tree document is based on the phenotypes (traits) that have been permitted for 

environmental releases under Animal and Plant Health Inspection Service (APHIS) oversight 

(for a list of approved notifications and environmental releases, visit Information Systems for 

Biotechnology). APHIS will re-evaluate and update this decision document as it receives new 

applications for environmental releases of new traits that are genetically engineered into plants.

BACKGROUND

For each transgene(s)/transgenic plant, the following information, data, and questions are 

addressed by APHIS, and the environmental analysis (e.g., environmental assessment [EA] or 

environmental impact statement [EIS]) for each petition will be publicly available. The APHIS 

review encompasses:

• A review of the biology, taxonomy, and weediness potential of the crop plant and its 

sexually compatible relatives;

• Characterization of each transgene with respect to its structure and function and the 

nature of the organism from which it was obtained;

• A determination of where the new transgene and its products (if any) are produced in the 

plant and their quantity;

• A review of the agronomic performance of the plant including disease and pest 

susceptibilities, weediness potential, and agronomic and environmental impact;

• Determination of the concentrations of known plant toxicants (if any are known in the 

plant); and

• Analysis to determine if the transgenic plant is sexually compatible with any threatened 

or endangered plant species or a host of any threatened or endangered plant species.

The U.S. Food and Drug Administration (FDA) published a policy in 1992 on foods derived 

from new plant varieties, including those derived from transgenic plants (see 

http://www.fda.gov/food/biotechnology/default.htm). Under this policy, FDA considers its 

existing statutory authorities to be “fully adequate to ensure the safety of new ingredients and 

foods derived from new varieties of plants, regardless of the process by which such foods and 

ingredients are produced (U.S. FDA, 1992). Thus, genetically engineered foods must meet the 

114
same rigorous safety standards as are required of all other foods. Many of the food crops 

currently being developed using biotechnology do not contain substances that are significantly 

different from those already consumed by humans and so may be less likely to require premarket approval. FDA expects developers to consult with the agency on safety and regulatory 

questions. A list of consultations is available at 

http://www.fda.gov/Food/Biotechnology/Submissions/default.htm. APHIS considers the status 

and conclusion of the FDA consultations in its EAs and EISs. 

Below is the description of the APHIS review process to determine if consultation with USFWS 

is necessary. If the answer to any of the questions below is “yes,” APHIS contacts USFWS to 

determine if consultation is required.

1. Is the transgenic plant sexually compatible with a threatened or endangered plant12

without human intervention?

2. Are naturally occurring plant toxins (toxicants) or allelochemicals increased over the 

normal concentration range in parental plant species?

3. Does the transgene product or its metabolites have any significant similarities to known 

toxins13)?

4. Will the new phenotype(s) imparted to the transgenic plant allow the plant to be grown or 

employed in new habitats (e.g., outside the agro-ecosystem)14?

5. Does the pest resistance15 gene act by one of the mechanisms listed below? If the answer 

is “yes,” then consultation with USFWS is NOT necessary.

A. The transgene acts only in one or more of the following ways:

i. As a structural barrier to either the attachment of the pest to the host, to penetration of the 

host by the pest, to the spread of the pest in the host plant (e.g., the production of lignin, 

callose, thickened cuticles);

ii. In the plant by inactivating or resisting toxins or other disease causing substances 

produced by the pest;

iii. By creating a deficiency in the host of a component required for growth of the pest (such 

as with fungi and bacteria);

12 APHIS will provide USFWS a draft EA that addresses the impacts, if any, of gene movement to the threatened or 

endangered plant.

13 Via a comparison of the amino acid sequence of the transgene’s protein with those found in the protein databases 

like PIR, Swiss-Port, and HIV amino acid databases.

14 Such phenotypes might include tolerance to environmental stress such as drought, salt, frost, and aluminum or 

heavy metals.

15 Pest resistance would include any toxin or allelochemical that prevents, destroys, repels, or mitigates a pest or 

affects any vertebrate or invertebrate animal, plant, or micro-organism.

115

 
iv. By initiating, enhancing, or potentiating the endogenous host hypersensitive disease 

resistance response found in the plant; or

v. In an indirect manner that does not result in killing or interfering with normal growth, 

development, or behavior of the pest;

B. A pest derived transgene is expressed in the plant to confer resistance to that pest (such as 

with coat protein, replicase, and pathogen virulence genes).

For the biotechnologist:

Depending on the outcome of the decision tree, initial the appropriate decision below and 

incorporate its language into the EA or EIS. Retain a hard copy of this decision document 

in the petition’s file.

__________ BRS has reviewed the data in accordance with a process mutually agreed upon 

with the U.S. Fish and Wildlife Service to determine when a consultation, as 

required under Section 7 of the Endangered Species Act, is needed. APHIS has 

reached a determination that the release following a determination of 

nonregulated status would have no effects on listed threatened or endangered 

species and consequently, a written concurrence or formal consultation with the 

U.S. Fish and Wildlife Service is not required for this EA or EIS.

__________ BRS has reviewed the data in accordance with a process mutually agreed upon 

with the U.S. Fish and Wildlife Service to determine when a consultation, as 

required under Section 7 of the Endangered Species Act, is needed. APHIS 

reached a determination that the release following a determination of 

nonregulated status is not likely to adversely affect any listed threatened or 

endangered species and consequently obtained written concurrence from the U.S. 

Fish and Wildlife Service.

__________ BRS has reviewed the data in accordance with a process mutually agreed upon 

with the U.S. Fish and Wildlife Service to determine when a consultation, as 

required under Section 7 of the Endangered Species Act, is needed. APHIS 

reached a determination that the release following a determination of 

nonregulated status is likely to adversely affect one or more listed threatened or 

endangered species and has initiated formal consultation with the U.S. Fish and 

Wildlife Service.

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