Monsanto Petition (11-188-01p) for Determination of 

Nonregulated status for MON 88302 (Herbicideresistant Canola)

OECD Unique Identifier: 

MON 883Ø2-9

Environmental Assessment 

April, 2013

Agency Contact 

Cindy Eck

Biotechnology Regulatory Services

4700 River Road

USDA, APHIS 

Riverdale, MD 20737 

Fax: (301) 734-8669

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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.

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TABLE OF CONTENTS PAGE

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

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

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

1.3 Coordinated Framework Review and Regulatory Review.......................................................2

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

1.3.2 Environmental Protection Agency..................................................................................3

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

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

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

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

2.1 Agricultural Production of Canola ...........................................................................................8

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

2.1.2 Land use ........................................................................................................................10

2.1.3 Agricultural Production of Canola................................................................................11

2.1.4 Canola Seed Production................................................................................................12

2.2 Physical Environment.............................................................................................................12

2.2.1 Water Resources ...........................................................................................................12

2.2.2 Soil Quality ...................................................................................................................13

2.2.3 Air Quality ....................................................................................................................13

2.2.4 Climate Change.............................................................................................................13

2.3 Biological Resources..............................................................................................................14

2.3.1 Animal Communities....................................................................................................14

2.3.2 Plants Communities......................................................................................................14

2.3.3 Microorganisms ............................................................................................................15

2.3.4 Biodiversity...................................................................................................................17

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TABLE OF CONTENTS PAGE

(Continued)

2.4 Human Health.........................................................................................................................17

2.4.1 Consumer Health ..........................................................................................................17

2.4.2 Worker Health...............................................................................................................18

2.5 Animal Feed ...........................................................................................................................19

2.6 Socioeconomics......................................................................................................................20

2.6.1 Domestic Canola Production ........................................................................................20

2.6.2 Organic Farming ...........................................................................................................22

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

3. ALTERNATIVES..................................................................................................................25

3.1 No-Action Alternative: Continuation as a Regulated Article ...............................................25

3.2 Preferred Alternative: Determination That MON 88302 Canola Is No Longer a Regulated 

Article...........................................................................................................................................25

3.3 Alternatives Considered But Rejected from Further Consideration ......................................26

3.3.1 Prohibit Any MON 88302 Canola from Being Released .............................................26

3.3.2 Approve the Petition in Part..........................................................................................26

3.3.3 Production/Geographical Restrictions to Isolate MON 88302 Canola from Non-GE 

Canola......................................................................................................................26

3.3.4 Requirement of Testing for MON 88302 Canola .........................................................27

3.3.5 Comparison of Alternatives..........................................................................................27

4. ENVIRONMENTAL CONSEQUENCES ............................................................................36

4.1 Scope of Analysis...................................................................................................................36

4.2 Acreage and Area of Canola Production................................................................................36

4.2.1 Agricultural Production of Canola................................................................................38

4.2.2 Canola Seed Production................................................................................................52

4.2.3 Organic Canola Production...........................................................................................52

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

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TABLE OF CONTENTS PAGE

(Continued)

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

4.4.4 Canola Seed Production................................................................................................67

4.4.5 Microorganisms ............................................................................................................68

4.4.6 Biodiversity...................................................................................................................70

4.5 Human Health.........................................................................................................................71

4.5.1 Consumer Health ..........................................................................................................71

4.5.2 Worker Health...............................................................................................................73

4.6 Animal Feed ...........................................................................................................................74

4.7 Socioeconomic Impacts..........................................................................................................75

4.7.1 Domestic production of canola .....................................................................................75

4.7.2 Organic Market for Canola ...........................................................................................77

4.7.3 Trade Economic Environment ......................................................................................78

5. CUMULATIVE IMPACTS...................................................................................................82

5.1 Assumptions Used for Cumulative Impacts Analysis............................................................82

5.2 Past and Present Actions ........................................................................................................83

5.3 Reasonably Foreseeable Actions............................................................................................85

6. THREATENED AND ENDANGERED SPECIES ..............................................................87

6.1 Potential Effects of Monsanto 88302 Canola on TES and Critical Habitat ...........................89

6.2 Potential Impacts of Glyphosate Use on TES and Critical Habitat........................................89

7. CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND TREATIES 

RELATING TO ENVIRONMENTAL IMPACTS.......................................................................92

7.1 Executive Orders with Domestic Implications.......................................................................92

7.2 International Implications.......................................................................................................93

7.3 Compliance with Clean Water Act and Clean Air Act ..........................................................95

7.4 Impacts on Unique Characteristics of Geographic Areas ......................................................95

7.5 National Historic Preservation Act (NHPA) of 1966 as Amended........................................96

8. REFERENCES ......................................................................................................................98

9. LIST OF PREPARERS........................................................................................................114

APPENDIX A. APHIS THREATENED AND ENDANGERED SPECIES DECISION TREE

FOR U.S. FISH AND WILDLIFE SERVICE CONSULTATIONS...........................................115

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LIST OF FIGURES

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

Figure 2. Major Canola-growing Region of North Dakota.......................................................... 11

Figure 3. U.S. Canola Oil Production, 1987-2009....................................................................... 37

Figure 4. Changes in Adoption of HR-Canola Varieties by Canadian Growers Since 1995 ...... 38

Figure 5. U.S./Canada Market Growth:Ten-year Projection of Herbicide-................................ 48

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

Figure 7. U.S. Canola Acreage: 1991-2012................................................................................. 76

Figure 8. U.S. Exports of Canola 2007-2012............................................................................... 80

Figure 9. Canola Seed Quantities in the U.S. .............................................................................. 81

LIST OF TABLES

Table 1. Total U.S. Canola Acreage, 1991-2010........................................................................... 8

Table 2. Weed Species Detected in North Dakota Canola Production Fields............................. 16

Table 3. Canola Acreage

1 Planted and Harvested in the U.S.: 2011-2012.................................. 22

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

Table 5. Guide to Timing of Canola Rotation Crops................................................................... 40

Table 6. Herbicide Plant-back Restrictions for Canola ............................................................... 42

Table 7. Pesticide Seed Treatments Registered for Use on Canola............................................. 45

Table 8. Registered Herbicides Commonly Used on Canola in the U.S. .................................... 49

Table 9. Registered Herbicides for Herbicide-resistant Canola.................................................... 49

Table 10. Herbicide-resistant Weeds of 25 Canola-producing States .......................................... 50

Table 11. Acreage of Herbicide-Resistant Canola Varieties Grown In North Dakota................ 52

Table 12. Herbicides and Application Methods1 Used in North Dakota Canola......................... 64

Table 13. Canola Price/Hundred Weight and Value of U.S Production for 2009-2011.............. 77

Table 14. Harvest and Value of Sales from Certified Organic Canola Farms in 2008................ 78

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ACRONYMS AND ABBREVIATIONS

a.i.

AIA

AMPA

AMS

active ingredient

advanced informed agreement

aminomethylphosphonic acid

Agricultural Marketing Service (within USDA)

AOSCA American Organization of Seed Certifying Agencies

APHIS Animal and Plant Health Inspection Service (within USDA AMS)

BMP

BRAD

Best Management Practice

Biopesticide Registration Action Document

BRS Biotechnology Regulatory Services (within USDA–APHIS)

Bt Bacillus thuringiensis

CAA

CRLF

Clean Air Act

California Red-legged Frog

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

ESU

Endangered Species Act of 1973

Evolusionarily significant unit

FDA U.S. Food and Drug Administration 

FFDCA Federal Food, Drug, and Cosmetic Act

FFP food, feed, or processing

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ACRONYMS AND ABBREVIATIONS

FIFRA

FONSI

FQPA

Federal Insecticide, Fungicide, and Rodenticide Act

Finding of No Significant Impact

Food Quality Protection Act

FR

FWS

Federal Register

Fish and Wildlife Service (of the U.S)

GDP gross domestic product

GE genetically engineered

GHG greenhouse gas

GR glyphosate-resistant

GRAS

HED

HR

HRAC

IP

generally recognized as safe

EPA Health Effects Division

Herbicide Resistant

Herbicide Resistance Action Committee

Identity Preservation

IPCC Intergovernmental Panel on Climate Change

IPPC International Plant Protection Convention

IRM Insect Resistance Management

ISPM International Standard for Phytosanitary Measures

LD50

LMO

M

NGO

lethal dose that kills 50% of the animals being tested

living modified organism

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

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ACRONYMS AND ABBREVIATIONS

NMFS National Marine Fisheries Service

NOEL

NOP

NPS

no observable effect level

National Organic Program (of USDA AMS)

non-point source

NRC

OFPA

ODA

PIP

PM

POEA

National Research Council

Organic Foods Production Act

Oregon Department of Agriculture

Plant-incorporated protectants

Particulate matter

Polyethoxylated tallow amine

PPA Plant Protection Act

PPE

PPM

PPRA

Personal Protective Equipment

parts per million

Plant Pest Risk Assessment

PRA pest risk analysis

RNA

SOM

SSA

ribonucleic acid

soil organic matter

sole source aquifer

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

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)

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1. PURPOSE AND NEED

1.1 Background

Monsanto Company of St. Louis, MO (henceforth referred to as Monsanto) submitted petition 

11-188-01p to the United States Department of Agriculture (USDA) Animal and Plant Health 

Inspection Service (APHIS) in June 2011 (Monsanto, 2011). The purpose of the petition is to 

support a determination of nonregulated status for Canola event MON 88302 (henceforth 

referred to as MON 88302 Canola), which is resistant1 to the herbicide, glyphosate. The MON 

88302 Canola variety is currently regulated under Title 7 of the Code of Federal Regulations (7 

CFR) part 340. Interstate movement and field trials of MON 88302 Canola have been conducted 

under permits issued or notifications acknowledged by APHIS since 2005. These field trials 

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

Minnesota, Montana, New Jersey, North Dakota, South Dakota, and Washington. Data resulting 

from these field trials are described in the MON 88302 Canola petition (Monsanto, 2011) and 

analyzed for plant pest risk in the USDA-APHIS Plant Pest Risk Assessment (PPRA) (USDAAPHIS, 2012b).

The petition stated that APHIS should not regulate MON 88302 Canola because it does not 

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

MON 88302 Canola, any progeny derived from crosses between MON 88302 Canola and 

conventional canola, and crosses of MON 88302 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

The current Roundup Ready canola product has restrictions in application rates and timing 

because of low expression of cp4-epsps in male reproductive tissue (USDA-APHIS, 2012b). 

MON 88302 allows for a wider period of application up to first flower instead of the 6-leaf 

growth stage. Label requirements applicable to glyphosate treatments made to the currently 

1

“Resistance” to herbicides is defined by the 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. Several technologies are available that can be used to develop herbicide resistance in plants 

including classical breeding, tissue culture, mutagenesis and genetic engineering. “Tolerance” is distinguished from 

resistance and defined by HRAC (2013) as the inherent ability of a plant to survive and reproduce following 

exposure to a herbicide treatment. This implies the circumstance in which there is no selection or genetic 

manipulation to make the plant tolerant; it is naturally tolerant. Throughout this EA (Environmental Assessment), 

APHIS has used the terms “resistance” and “tolerance” consistent with the definitions of the HRAC. It should be 

noted however, that different terms for the same concept may be used interchangeably in some instances. In its 

petition to USDA APHIS (Monsanto, "Petition for the Determination of Non-Regulated Status Fir GlyphosateTolerant Canola Mon 88302 ", ed. M. A. Wideman (Monsanto Company, 2011), vol. referenced the subject as, 

“Glyphosate-Tolerant Canola,” and used the term “herbicide-tolerant” throughout it documentation to describe it. 

This terminology can be considered synonymous with “herbicide-resistant” (HR) used in this EA.

1

 
available, Monsanto, GE-(genetically-engineered) spring-canola cultivar (RT73) allow for only a 

single application of 0.39-0.56 lbs. of glyphosate a.i. (active ingredient) per acre up to the 6-leaf 

growth stage. This restriction is further limited to 0.39 lbs. a.i. after the 4-leaf stage. MON 

88302 Canola is sufficiently resistant to tolerate higher glyphosate application rates equal to the 

maximum amount of a.i. currently approved for GR (glyphosate-resistant) corn and soybeans. 

This proposed maximum glyphosate application rate on MON 88302 is twice the currently 

labeled maximum application rate for RT73. Therefore, in contrast to existing GR-canola 

products on the market today, MON 88302 Canola will provide growers with an alternative GR 

variety that offers greater potential and flexibility in the weed-control strategy they select by 

allowing for a higher application rate of glyphosate to canola across a wider range of 

developmental crop stages.

1.3 Coordinated Framework Review and Regulatory Review

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

regulations published in the Federal Register entitled The Coordinated Framework for the 

Regulation of Biotechnology (51 FR 23302, 1986)(henceforth referred to here as the 

Coordinated Framework), and the policy statement for foods derived from new plant varieties 

(57 FR 22984, 1992). 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. 

2
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 

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 

3
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.

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 currently 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 MON 88302 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 Monsanto requesting a determination of nonregulated 

status for MON 88302 Canola. APHIS has prepared this EA to consider the potential 

environmental effects of an agency determination of nonregulated status of MON 88302 Canola. 

This action is consistent with regulations for the National Environmental Policy Act (NEPA) 

established by the Council of Environmental Quality (CEQ), and those of 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 MON 88302 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 

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

 
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 publishes two separate notices in the Federal Register for petitions for which APHIS 

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

announces the availability of the APHIS decision-making documents. As part of the new 

process, with each of the two notices published in the Federal Register, there is an opportunity 

for public involvement:

1.5.1 First Opportunity for Public Involvement

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

to provide an opportunity to comment on issues regarding the petition itself and give 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 is announced in a Federal Register

notice.

1.5.2 Second Opportunity for Public Involvement

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

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

approaches for public participation based on whether or not 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 it involves a GE organism that does not raise new 

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

Agency’s 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 no information is received that would warrant substantially changing the APHIS analysis or 

determination, the Agency’s preliminary regulatory determination becomes effective upon public 

notification through an announcement on its website. No further Federal Register notices are 

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 involves substantive 

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

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

modifications involves substantive biological, cultural, or ecological issues not previously 

analyzed by APHIS. Substantive issues are identified based on the Agency’s review of the 

5
petition and its evaluation and analysis of comments received from the public during the 60-day 

comment period for the petition. 

APHIS solicits comments on its draft EA and draft PPRA for 30 days, as announced in 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, then announces its decision in the Federal 

Register, and provides notice of the availability of the final EA, PPRA, NEPA decision 

document, and regulatory determination.

More details about this expansion of opportunities for stakeholder review and comment are 

available in the Federal Register notice4 published on March 6, 2012.

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

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

response to the Federal Register notice (77 F.R. 41357-8) 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 MON 88302 Canola.

The public comment period for MON 88302 Canola petition closed on September 11, 2013. At 

its closing, the docket file contained a total of 4,670 public comments. These were screened and 

sorted into categories according to the subject matter addressed (e.g., air, water, soil impacts), 

and classified as either non-substantive or substantive. Most of the comments were nonsubstantive and 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. Substantive comments identified the 

following issues:

• Canola outcrossing with other mustards

• Canola forming feral populations

• Development of HR weeds

• Use of herbicides on HR 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

4

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

6

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

will affect sales for growers of these crops.

• Concerns that MON 88302 Canola is not approved in all export markets.

APHIS evaluated these issues and provided citations and has included a discussion of these 

issues in this EA where appropriate.

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 Agricultural Production of Canola

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, reserving the name “canola” to describe them. By definition, canola oil contains less 

than 2% erucic acid; 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 eruic 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 reach 55-60°F (Atkinson et al., 2006).

2.1.1 Canola Production in North America

During 2001-2010, canola production in the U.S. averaged 1.2M (million) acres (Table 1).

Table 1. Total U.S. Canola Acreage, 1991-2010

8
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

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

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

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

preferred by most corn and soybean varieties. Most of this region is in the prairie provinces of 

Canada, but part of it extends into North Dakota (Figure 1).

9
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 canolagrowing regions where canola is rotated with other crops, but is not a major crop of that region.

2.1.2 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).

10
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.

2.1.3 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. 

11
2.1.4 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 7.5M 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 

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

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

A substantial 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).

12
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). 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 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 HR 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 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 

it reduces emissions.

2.2.4 Climate Change

Climate change represents a sustained, statistically significant 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 been a major contributor to 

the increase 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 increase in 

the concentration of some important GHGs are as follows: CO2, 36%; CH4, 148% and N2O, 18%

(US-EPA, 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 

13
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..

2.3.1 Animal Communities

The affected environment for growing canola plants can generally be considered the

agroecosystem (managed agricultural fields) plus adjacent areas extending beyond the intended

plantings that might be affected by agricultural operations. Mammals and birds, including

migratory mammals and birds, may seasonally consume seeds from the planted fields, and

invertebrates can feed on the plant and surrounding vegetation during the entire growing season.

Rodents and other small animals may inhabit canola fields, and the raptors, snakes and

other animals that may prey on them are part of the affected environment. Deer may also

browse in canola fields on the forage. Fish and other aquatic organisms in streams draining

agricultural fields are also part of the affected environment.

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 waterways 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 visit 

canola. Many local native pollinators may also visit fields when they are flowering (ScottDupree 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 

14
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 (CFIA, 1994; OECD, 1997; CCC, 2003).

They produce large numbers of seeds, some of which have prolonged dormancy that can cause 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 (Conringia orientalis), and common peppergrass (Lepidium 

densiflorum) (CFIA, 1994; OECD, 1997; CCC, 2003). Other weeds include cleavers (Galium 

aparine), stork’s bill (Erodium circutarium), 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. 

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). B. napus can also interact 

with certain plants through sexual reproduction. B. napus is predominantly self-pollinating 

although interplant (plants that are adjacent to each other) 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 (OGTR, 2008) 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 

15
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).

Table 2. Weed Species Detected in North Dakota Canola Production Fields

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

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

16
1

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

quadrants.

2.3.4 Biodiversity

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

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

(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 harvesting limit the 

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

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 (e.g., compost, green manure, animal manure), hedgerows and windbreaks 

(Altieri, 1999).

2.4 Human Health

Humans interact with canola either as consumers of canola derived products or as workers who 

produce canola crops..

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 

17
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 Organization for Economic Development (OECD, 2001) canola oil has one 

component, erucic acid, that is (as already noted here), associated with negative human health 

impacts. 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, 2011h). 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).

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).

Glyphosate 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 

HED (Health Effects Division) determined that the main metabolite of glyphosate, AMPA

(aminomethylphosphonic acid), should not be regulated even though detectable levels sometimes 

occur in both foods for human consumption and animal 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.

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

18

 
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 most recent 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, 2011i). 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 protective 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 handlers and applicators. 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, 

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 pollen from Brassica spp. the general population are rare (Soutar, 1994), 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. Most of canola meal in the United States is fed to cattle and pigs as 

part of a feed ration. It can also be used as feed for 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).

19
Regulatory control of feed manufacturers is similar to that for producers of food for direct human

consumption. 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 feed containing GE-plant material is 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 tier 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 harvest totaled 85M pounds 

valued at $20.5M (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 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 less 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 (ODA)

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 between fields is 

prescribed by ODA. On February 8, 2013, ODA published an administrative rule amending the 

“General Production Area/Protected Districts” in the Rapeseed Control Area (OAR 603-052-

0860) (Oregon-Department-of-Agriculture, 2013). Under the rule, a rapeseed exclusion zone has 

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

state.

20
21
Table 3. 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)

The administrative rule establishes a canola production exclusion zone in the Willamette Valley, 

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 canola production but 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 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 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, each year an accredited organic certifying agent must review an 

operation. This must include a review of its organic system plan and record-keeping practices, 

22
and an on-site inspection of the production area(s). Organic growers must maintain records to 

show that production and handling procedures comply with USDA organic standards.

Section 205.105 of the regulations identifies “Allowed and prohibited substances, methods, and 

ingredients in organic production and handling.

“To be sold or labeled as ‘100 percent organic,’ ‘organic,’ or ‘made with organic’ (specified 

ingredients or food group(s)),” the product must be produced and handled without the use of: . . . 

(e) Excluded methods . . . .”

Excluded methods identified at 7 CFR Section 205.2, are defined as follows:

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

growth and development by means that are not possible under natural conditions 

or processes and are not considered compatible with organic production. Such 

methods include cell fusion, microencapsulation and macroencapsulation, and 

recombinant DNA technology (including gene deletion, gene doubling, 

introducing a foreign gene, and changing the positions of genes when achieved 

by recombinant DNA technology). Such methods do not include the use of 

traditional breeding, conjugation, fermentation, hybridization, in vitro 

fertilization, or tissue culture.”

Organic farming operations, as described 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 

organic and neighboring fields to minimize the chance for pollen exchange between 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 if excluded methods were 

used and reasonable practices were implemented to avoid contact with products of excluded 

methods as detailed in their approved organic system plan (Ronald and Fouche, 2006; USDAAMS, 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. 

23
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 

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

vegetables.

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). 

24
3. ALTERNATIVES

This document analyzes the potential environmental consequences of a determination of 

nonregulated status of MON 88302 Canola. To respond favorably to a petition for nonregulated 

status, APHIS must determine that MON 88302 Canola is unlikely to pose a plant pest risk. 

Based on its PPRA (USDA-APHIS, 2012b), APHIS has concluded that MON 88302 Canola is 

unlikely to pose a plant pest risk. Therefore, APHIS must determine that MON 88302 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 MON 88302 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-action Alternative, APHIS would deny the petition. MON 88302 Canola and 

progeny derived from MON 88302 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 MON 88302 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 MON 88302 Canola.

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

a PPRA that MON 88302 Canola is unlikely to pose a plant pest risk (USDA-APHIS, 2012b). 

Choosing this alternative would not satisfy the purpose and need of making a determination of 

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

3.2 Preferred Alternative: Determination That MON 88302 Canola Is No Longer 

a Regulated Article

Under this alternative, MON 88302 Canola and progeny derived from them would no longer be 

regulated articles under the regulations at 7 CFR part 340 because MON 88302 Canola is 

unlikely to pose a plant pest risk (USDA-APHIS, 2012b). Permits issued or notifications 

acknowledged by APHIS would no longer be required for introductions of MON 88302 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 MON 88302 Canola is unlikely to pose a plant pest risk, a 

determination of nonregulated status of MON 88302 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 MON 88302 Canola and progeny 

derived from this event if the developer decides to commercialize MON 88302 Canola.

25
3.3 Alternatives Considered But Rejected from Further Consideration

APHIS assembled a list of alternatives that might be considered for MON 88302 Canola. The 

agency evaluated these alternatives in accordance with 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 MON 88302 Canola. Based on this evaluation, APHIS rejected several 

alternatives. These alternatives are described briefly below along with the specific reasons for 

rejecting each.

3.3.1 Prohibit Any MON 88302 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 MON 88302 Canola, including 

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

not appropriate because APHIS has concluded that MON 88302 Canola is unlikely to be a plant 

pest risk (USDA-APHIS, 2012b).

In enacting the PPA, Congress included findings 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, 2012b), APHIS concluded that MON 88302 Canola is unlikely to pose a 

plant pest risk. Therefore, there is no basis in science for prohibiting the release of MON 88302

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 MON 88302 Canola is unlikely to pose a plant pest risk and it is the only line in 

the petition, 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 MON 88302 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 MON 88302 Canola from non-GE canola

production. However, because APHIS has concluded that MON 88302 Canola is unlikely to 

26
pose a plant pest risk (USDA-APHIS, 2012b), 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 MON 88302 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 MON 88302 Canola, there are no geographic differences associated with any 

identifiable plant pest risks for MON 88302 Canola (USDA-APHIS, 2012b). This alternative 

was rejected and not analyzed in detail because APHIS has concluded that MON 88302 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 MON 88302 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 

MON 88302 Canola is available from the American Organization of Seed Certifying Agencies

(AOSCA, 2010).

3.3.4 Requirement of Testing for MON 88302 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 MON 88302 Canola does not pose a plant pest risk (USDA-APHIS, 2012b),

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 MON 88302 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 includes a summary of the potential impacts associated with selection of either of the 

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

27
Table 4. 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 – plant pest risk 

assessment (USDA-APHIS, 

2013b)

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. 

About 93% of it was located 

in North Dakota. 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 herbicideresistant weeds. About half of 

growers rely on a 3-year 

rotation of canola, a small 

grain, and soybean. The 

remaining growers use a twoyear rotation of canola/wheat.

The approved in-crop 

glyphosate application rate 

for MON 88302 Canola will 

increase from the rate 

currently approved for other 

GR-canola varieties to the 

rate currently approved for 

other GR-crops (e.g., 

soybean, maize, cotton, 

alfalfa).

28
Attribute/Measure Alternative A: No-Action

Alternative B: 

Determination of 

Nonregulated status

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. Specific 

treatment rates and crop stage 

restrictions apply to HR 

canola. 

The approved in-crop 

glyphosate application rate 

for MON 88302 Canola will 

increase from the rate 

currently approved for other 

GR-canola varieties to the 

rate currently approved for 

other GR-crops (e.g., 

soybean, maize, cotton, 

alfalfa).

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 

The approved in-crop 

glyphosate application rate 

for MON 88302 Canola will 

29
Attribute/Measure Alternative A: No-Action

Alternative B: 

Determination of 

Nonregulated status

tillage, which preserves soil 

quality by reducing erosion. 

Growers currently use best 

management practices to 

address their specific needs in 

producing canola.

increase from the rate 

currently approved for other 

GR-canola varieties to the 

rate currently approved for 

other GR-crops (e.g., 

soybean, maize, cotton, 

alfalfa), which do not have 

unacceptable impacts on 

soil quality.

Water Resources

The most important 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.

The approved in-crop 

glyphosate application rate 

for MON 88302 Canola will 

increase from the rate 

currently approved for other 

GR-canola varieties to the 

rate currently approved for 

other GR-crops (e.g., 

soybean, maize, cotton, 

alfalfa), which do not have 

unacceptable impacts on 

water resources.

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.

The approved in-crop 

glyphosate application rate 

for MON 88302 Canola will 

increase from the rate 

currently approved for other 

GR-canola varieties to the 

rate currently approved for 

other GR-crops (e.g., 

soybean, maize, cotton, 

alfalfa), which do not have 

unacceptable impacts on air 

quality.

Climate Change

Agriculture-related activities 

are direct sources of 

greenhouse gases(e.g., 

exhaust from motorized

No change from No-action

Alternative

30
Attribute/Measure Alternative A: No-Action

Alternative B: 

Determination of 

Nonregulated status

equipment) and indirect 

sources (e.g., soil disturbance 

from tillage, fertilizer

production)

Animal Communities

Invertebrates that feed on 

canola are typically 

considered pests and may be 

controlled by the use of 

insecticides or other 

production practices. Seed 

treatments are recommended 

to prevent flea beetle damage 

of young plants and foliar 

insecticide applications are 

recommended if damage 

reaches an economic 

threshold.

No change from No-action

Alternative

Plant Communities

Plants growing in canola fields 

are considered weeds. Weeds 

can complete with growing 

canola 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.

The approved in-crop 

glyphosate application rate 

for MON 88302 Canola will 

increase from the rate 

currently approved for other 

GR-canola varieties to the 

rate currently approved for 

other GR-crops (e.g., 

soybean, maize, cotton, 

alfalfa). the changes in the 

effects on plant 

communities associated 

with the preferred 

alternative would be 

minimal, and could have an 

overall positive effect on 

reducing weed resistance 

when compared to the Noaction Alternative. 

31
Attribute/Measure Alternative A: No-Action

Alternative B: 

Determination of 

Nonregulated status

Soil Microorganisms

APHIS has previously 

examined potential impacts of 

glyphosate on microorganisms 

in soils of field under 

cultivation with HR crops, and 

has not found evidence linking 

applications of glyphosate to 

changes in soil microbial 

communities that have adverse 

effects on plants grown in 

those soils.

The approved in-crop 

glyphosate application rate 

for MON 88302 Canola will 

increase from the rate 

currently approved for other 

GR-canola varieties to the 

rate currently approved for 

other GR-crops (e.g., 

soybean, maize, cotton, 

alfalfa), which do not have 

unacceptable impacts on 

microorganisms.

Biological Diversity

HR crops, such as canola, 

have been correlated with an 

increase in conservation 

tillage in U.S. crop 

production, which promotes 

biodiversity by allowing the 

establishment of other plants, 

and the accumulation of more 

plant residue that increases 

soil organic matter, food, and 

cover for wildlife. Effects of 

GE crops have been associated 

with positive impacts on 

biodiversity because of 

increased yields, fewer 

applications of less toxic 

pesticides, and facilitation of 

conservation tillage.

No change from No-action 

Alternative

Land Use

Canola is minor crop produced 

on approximately 0.04% of 

the harvested cropland in the 

U.S. 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

No change from No-action 

Alternative

32
Attribute/Measure Alternative A: No-Action

Alternative B: 

Determination of 

Nonregulated status

policy.

Human and Animal Health

Risk to Human Health

Canola oil has one component 

(erucic acid) of human health 

significance because of its 

toxic properties. Varieties that 

produce oil with less than 2% 

of this fatty acid are defined as 

canola, and are generally 

regarded as safe by FDA. 

Residues, such as that that 

might arise from the CP4 

EPSPS 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.

The approved in-crop

glyphosate application rate 

for MON 88302 Canola will 

increase from the rate 

currently approved for other 

GR-canola varieties to the 

rate currently approved for 

other GR-crops (e.g., 

soybean, maize, cotton, 

alfalfa). Application at the 

higher rate does not pose 

any unacceptable risks to 

consumer health and worker 

safety when applied in 

accordance with the 

glyphosate registration label 

requirements approved by 

USEPA.

Risk to Animal Feed

Most canola cultivated in the 

U.S. is used to produce 

vegetable oil and animal feed. 

Canola-based animal feed is 

currently produced from GE 

canola varieties that are no 

No change from No-action 

Alternative

33
Attribute/Measure Alternative A: No-Action

Alternative B: 

Determination of 

Nonregulated status

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.

Socioeconomic 

Domestic Economic 

Environment

Farm income is positively

impacted by currently

available HR canola by 

reducing production costs or 

increasing revenues. GR 

canola generally has a positive

impact on farm income due to

cost savings from reduced fuel 

and pesticide use.

No change from No-action 

Alternative

Trade Economic Environment

Because the U.S. crushes 

more canola seed than it 

produces, the U.S. imports 

canola seed to meet the 

demand of the oil market. 

The U.S. exported 150-300 

thousand metric tons of 

canola 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

34
Attribute/Measure Alternative A: No-Action

Alternative B: 

Determination of 

Nonregulated status

U.S. FDA completed 

consultations.

No change from No-action 

Alternative.

Satisfied: consultations with 

other agencies participating 

in the Coordinated 

Regulatory Framework 

completed.

Compliance with Other Laws

CWA, CAA, EOs

Fully compliant

No change from No-action

Alternative:

35
4. ENVIRONMENTAL CONSEQUENCES

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

the alternatives analyzed in this EA for MON 88302 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 reviewed 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 MON 88302 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. Of the remaining 16 states, five (Texas, 

36
Pennsylvania, Michigan, 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 860,000 acres of canola. In 2012, canola acreage in the

U.S. for all purposes was estimated to be 1.6M acres ( Table 3). This is an increase of 0.6M

acres from the previous year (USDA-NASS, 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 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 below U.S. demand.

By 2006, nearly all U.S. canola production 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. canola-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 

37
(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. 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.

GR 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, one of which is whether the variety is resistant to a particular herbicide. It is 

likely that canola acreage in the U.S. will continue to be planted predominantly with HR

varieties.

4.2.1 Agricultural Production of Canola

No Acton Alternative: Agricultural Production of Canola

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). 

38
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, 2009a).

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, 2009b). 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., 2010a). 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., 

2010a) are similar to methods used in states such as North Dakota and Minnesota where most of 

the U.S. canola production occurs (Table 3). 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., 2010b).

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 HR canola was observed between 

1999 and 2006 (Smyth et al., 2010a), a trend that is clearly correlated with increased adoption of 

HT canola (Duke and Powles, 2009b; Smyth et al., 2010a).

Despite the increasing flexibility in the ability to apply herbicides to control weeds, cultivation 

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., 

2010b). In some areas of the U.S., individual growers confronted by GR weeds recently resorted 

to tillage to achieve adequate control (Duke and Powles, 2009a). In general, GE crops have 

39
reduced tillage from 89% to 35%, but as this report shows, in some individual instances, tillage 

is useful in managing HR 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 increase the 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., 2009). Important 

control methods are rotation and disease-free, fungicide-treated seed (Luper et al., 2007).

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) reduses problematic weed populations for the canola plantings (NDSU, 2005). 

Rotation of crops often allows for different herbicide control options depending on the herbicideresistance traits available in that crop.

Table 5. Guide to Timing of Canola Rotation Crops

40
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

Soybeans

2 Common diseases are Rhizoctonia and 

Fusarium root rots and Sclerotinia stem rot.

Sunflowers 3 Common diseases are Rhizoctonia and 

Fusarium root rots and Sclerotinia stem rot.

Source: (Luper 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 and fungi (Brown et al., 

2008). The tap-root structure of canola plants promotes translocation of nutrients within the 

plant. This is important 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 

41
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).

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

42
Herbicide Common Name Plant Back Restriction on Herbicide Label

Pyraflufen 30 days

Flucarbazone 9 months

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

43
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)

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, gamma

cyhalothrin, 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 

44
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.

Table 7. Pesticide 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 fludioxonil) and 

an insecticide (thiamethoxam), to protect canola seed against seed- and soilborne diseases as well as flea beetles. Provides broad-spectrum protection 

against diseases such as seed rot, damping off, seedling blight, root rot and 

seed-borne blackleg.

Helix Lite

Contains three fungicides (difenoconazole, mefenoxam and fludioxonil) 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.

Source: (Brown et al., 2008)

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 

45
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 

rotated with wheat, sorghum, and corn to manage the problem weed complex of downy brome 

and Italian ryegrass (Luper et al., 2007).

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 a 

highly profitable short-term 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 increased selection on

resistant weeds in some field crops in the U.S. Growers with GR weeds in their fields may need 

to adopt alternative practices to help control them (Duke and Powles, 2009a). U.S. consumer

concerns regarding GE crops have been widespread, but they have not been reflected in the 

marketplace (Fernandez-Cornejo and Caswell, 2006).

One analysis of the adoption of transgenic crop varieties globally (Brookes and Barfoot, 2010)

indicated that the 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;

46
• 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, there was a substantial increase 

in the planting of HR varieties during the period 1999-2006 in the primary U.S production state 

of North Dakota from 25% to 99% (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 substantially changed cultivation acreage 

of canola 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 MON 88302 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, and 

6% were planted with imidazolinone-resistant Clearfield® varieties. These adoption rates 

demonstrate that producers are recognizing a substantial economic and environmental benefit 

from HR canola over non-HR varieties (Smyth et al., 2011).

An analysis of the long-term market for HR canola (USDA-APHIS, 2013c) indicates that 

glyphosate and glufosinate-resistant canola will remain popular with producers (Figure 5). 

Monsanto 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.

Herbicide Use and Weed Resistance. Compared to major crops such as corn, soybeans, and 

wheat, there are fewer herbicides available to canola growers. Registered herbicides for 

traditional canola are summarized in Table 8, and those for HR canola are listed in Table 9.

47
Figure 5. U.S./Canada Market Growth:Ten-year Projection of Herbicide-

 resistant Canola

RR/LL+CL = Roundup Ready x InVigor; CL = Clearfield; LL = InVigor;

RR = Roundup Ready

Source: (USDA-APHIS, 2013a)

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 HR weeds occur around the world (Weedscience.org, 2011).

Only two GR weed species (common ragweed and kochia) are found in canola weed surveys in 

North Dakota (Table 2). All GR weed species, except 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 ALS6

-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;

0

10

20

30

40

50

60

70

80

90

100

RR/LL

CL

LL

RR

% Canola Market

48

 
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: (USDA-APHIS, 2013a)

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

49
 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 ,

 Johnson grass Glycines

Hairy Fleabane Bipyridiliums and Glycines

Smooth Crabgrass Synthetic Auxins

Junglerice Glycines

Barnyardgrass ACCase inhibitors, Thiocarbamates and others, Synthetic

Late Watergrass ACCase inhibitors, Thiocarbamates and others

Rigid Ryegrass Glycines

Kochia Photosystem II inhibitors, ALS inhibitors, Synthetic Auxins,

Wild Oat ACCase inhibitors, Thiocarbamates, others, and Unknown

Common Waterhemp ALS inhibitors, Photosystem II inhibitors , Glycines

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

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

50
• glyphosate- and ALS-resistant common ragweed and horseweed in Ohio;

• glyphosate-, PPO7

-inhibitor- and ALS-resistant common waterhemp in Missouri;

• 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 the western provinces, where nearly all Canadian 

canola is produced (Smyth et al., 2010b), are virtually identical to U.S. cultivation methods in 

North Dakota, where most of the U.S. canola acreage is located (Table 3). The western Canada 

survey data indicate that for canola production, conventional tillage has become less expensive in 

recent years. For the period, 1999-2006, it was estimated that cultivation was less expensive 

than herbicide weed control options (Smyth et al., 2010b). 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., 

2010b). This increase in the use of no-till or minimum-till practices is correlated with increased 

adoption of HR canola (Duke and Powles, 2009a; Smyth et al., 2010b).

In general, GE crops have reduced tillage from 89% to 35%, but in some instances tillage is 

necessary for effective control of HR weeds. 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., 2010b). In some areas of the U.S., individual growers with GR weeds have 

recently resorted to tillage to control them (Duke and Powles, 2009a).

GE canola seeds average 30-40% more expensive than those for conventional varieties 

(Zollinger et al., 2008). Table 11 summarizes recent data (2008) by acreage planted for GE-, 

HR-canola types in North Dakota (Zollinger et al., 2008).

Preferred Alternative: Agricultural Production of Canola

As described in the No-action Alternative, agricultural practices are influenced by disease, insect

and weed pressures. Approving the petition for nonregulated status would not change the effects 

of canola farming on agronomic practices used for disease and insect control. However, 

approval of MON 88302 Canola would allow greater latitude in the application of glyphosate in 

response to weed pressures. This would include making applications at twice the rate currently 

allowed for canola production because MON 88302 Canola is more resistant to glyphosate 

exposure than that of other HR-canola varieties now in production. It would also allow for 

making applications to canola crops in later stages of development. Currently approved canola 

varieties can only withstand glyphosate treatments until they reach the six-leaf stage of 

development. In contrast, stands of MON 88302 Canola can be treated until they reach the 

7 Protoporphyrinogen oxidase

51

 
flowering stage. The net effect of the changes allowed for glyphosate applications to MON 

88302 Canola is that the amount of a.i. would only increase to that permitted for use on other GR 

crops that are included among those used in rotation with canola.

4.2.2 Canola Seed Production

No Acton Alternative: Canola Seed Production

Under the No-Action Alternative, current canola seed production practices are not expected to 

change from continued regulation of MON 88302 Canola and its progeny under 7 CFR part 340 

and the plant pest provisions of the PPA. MON 88302 Canola would be cultivated for seed in a 

limited area independent of any commercial seed production. Field tests (Monsanto, 2011) have 

determined that MON 88302 Canola is not significantly different from other canola cultivars,

including non-GE and other GE-canola varieties, all of which are currently planted in the 

primary canola-growing state of North Dakota (See Table 11). It is also expected that canola 

seed producers would continue to implement measures to preserve the identity of their seed 

varieties. No changes to canola seed production practices or locations would occur under the 

No-action Alternative.

Preferred Alternative: Canola Seed Production

Monsanto seed field trials have not demonstrated any agronomic or phenotypic differences 

between MON 88302 Canola and control canola cultivars (Monsanto, 2011). Under the 

preferred alternative with nonregulated status, MON 88302 Canola would likely replace some 

other commercial GR canola cultivars on current production acres.

Based on the data provided by Monsanto for MON 88302 Canola, as well as previous experience 

with other GE herbicide-resistant canola varieties that have been widely adopted by growers 

since their commercial availability in 1996, APHIS has concluded that the availability of MON 

88302 Canola under the Preferred Alternative would not alter the agronomic practices, 

cultivation locations, seed production practices or quality characteristics of conventional and 

non-GE canola seed production (Monsanto, 2011). No change to seed production practices 

would be required if MON 88302 Canola were no longer regulated. The potential impacts to 

canola seed production associated with the Preferred Alternative would be the same as the Noaction Alternative.

4.2.3 Organic Canola Production

No-action Alternative: 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, 

certain markets or contracts may have defined thresholds (Non-GMO-Project, 2010).

Table 11. Acreage of Herbicide-Resistant Canola Varieties Grown In North Dakota

52
District

 HRCanola 

Acres1

 Resistant Variety

Glyphosate Liberty Clearfield2

Acres % of 

Total Acres % of Total Acres % of Total

Northwest 223.0 126.1 56.6 95.7 42.9 1.2 0.5

West 

Central 78.0 60.0 76.9 17.1 21.9 ND3 ND

Central 34.5 11.7 34.0 18.7 54.2 3.7 10.8

East 

Central 4.5 3.2 71.7 1.3 28.3 ND ND

Southwest 43.0 33.0 76.8 7.8 18.2 ND ND

South 

Central 9.0 ND ND ND ND ND ND

State Total 910.0 507.0 55.7 355.6 39.1 17.4 1.9

1

in thousands of acres

2

Clearfield is a variety with a trait developed by traditional plant breeding, so it is not a GE variety.

3

No available data

Source (Zollinger et al., 2008).

 

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 nonregulated status of MON 88302 Canola would not change the 

effects of canola farming on organic resources. Because most canola production currently uses 

HR-canola varieties, the introduction of an additional GR variety with the same potential for 

cross-pollination as existing non-regulated 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.

53
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 is the Federal Water 

Pollution Control Act of 1972, also known as the Clean Water Act (CWA) (US-EPA, 2011h). 

The CWA authorizes the establishment of water quality standards, permit requirements, and 

monitoring to establish a legal framework to protect and enhance domestic water quality. 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, 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 (USEPA, 2011e). 

54
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 

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

With one exception, there would be no difference from the No-action Alternative for water 

resources from approving the petition for nonregulated status for MON 88302. Approval of the 

petition would make available a new canola variety that has a higher in-crop glyphosate 

application rate (i.e., the total amount that can be applied annually to a crop) than that of other 

currently available GR canola varieties. The higher in-crop rate for MON 88302 Canola is 

however, less than or comparable to the in-crop rate currently allowed for GR sugar beets, 

alfalfa, corn, soybeans and cotton. Except for GR sugar beets, all of these are crops 

recommended in rotation with canola (Table 5), so fields used for GR canola plantings are 

already potentially subject to the higher in-crop glyphosate application rate. All of these GR 

crops cited here are no longer regulated by APHIS. As part of its decisionmaking process for 

these GR crops, APHIS prepared EAs (and/or EISs) and analyzed the potential effects on several 

different physical parameters, including water, that are associated with the higher glyphosate 

55
application rate now proposed for MON 88302 (USDA-APHIS, 2000; USDA-APHIS, 2004; 

USDA-APHIS, 2010b; USDA-APHIS, 2012a). EPA has also determined that use, in accordance 

with the labeling of currently registered pesticide products containing glyphosate, will not pose 

unreasonable risks or adverse effects on water and water use as well as soil, climate, and air 

quality. Based on these considerations, APHIS has concluded 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 

medium textured, well-drained soils 

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;

56
• reducing potential for erosion;

• providing energy for microorganisms;

• improving infiltration and water-holding capacity;

• promoting nutrient cycles;

• increasing cation exchange capacity8

;

• 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 GHGs (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 

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 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 

8 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

 
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, which increases its 

availability for plant uptake, microbial degradation, and leaching (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 

those cations9 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

With one exception, there would be no difference from the No-action Alternative for soil quality 

by approving the petition for nonregulated statusfor MON 88302. Approval of the petition 

would make available a new canola variety that has a higher in-crop glyphosate application rate 

than that of other currently available GR canola varieties. The higher in-crop rate for MON 

88302 Canola is however, less than or comparable to the in-crop rate currently allowed for GR 

sugar beets, alfalfa, corn, soybeans and cotton. Except for GR sugar beets, all of these are crops 

9 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+). 

58

 
recommended in rotation with canola (Table 5), so fields used for GR canola plantings are 

already potentially subject to the higher in-crop glyphosate application rate. All of these GR 

crops cited here are no longer regulated by APHIS. As part of its decisionmaking process for 

these GR crops, APHIS prepared EAs (and/or EISs) and analyzed the potential effects on soil 

associated with the higher glyphosate application rate now proposed for MON 88302 (USDAAPHIS, 2000; USDA-APHIS, 2004; Rood, 2007; USDA-APHIS, 2010b){USDA-APHIS, 2012 

#631. EPA has also determined that use in accordance with the labeling of currently registered 

pesticide products containing glyphosate will not pose unreasonable risks or adverse effect to 

soil, climate, air quality or water and water use. Based on these considerations, APHIS has 

concluded there would be no changes in the direct or indirect effects on soil quality from the 

preferred alternative.

4.3.3 Air Quality

No-action Alternative: 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 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 described 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 

thereafter, to any site other than that intended for application” {US-EPA, 2000 #638}. 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 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 

59
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. They 

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. With one exception, there would be no difference from the No-action Alternative 

on air quality by approving the petition for nonregulated status for MON 88302. Approval of the 

petition would make available a new canola variety that has a higher in-crop glyphosate 

application rate (i.e., the total amount that can be applied annually to a crop) than that of other 

currently available GR canola varieties. The higher in-crop rate for MON 88302 Canola is 

however, less than or comparable to the in-crop rate currently allowed for GR sugar beets, 

alfalfa, corn, soybeans and cotton. Except for GR sugar beets, all of these are crops 

recommended in rotation with canola (Table 5), so fields used for GR canola plantings are 

already potentially subject to the higher in-crop glyphosate application rate. All of these GR 

crops cited here are no longer regulated by APHIS. As part of its decision-making process for 

these GR crops, APHIS prepared EAs (and/or EISs) and analyzed the potential effects on air 

quality associated with the higher glyphosate application rate now proposed for MON 88302 

(USDA-APHIS, 2000; USDA-APHIS, 2004; USDA-APHIS, 2010b; USDA-APHIS, 2012a). 

EPA has also determined that use in accordance with the labeling of currently registered 

pesticide products containing glyphosate will not pose unreasonable risks or adverse effect to 

soil, climate, air quality or water and water use. Based on these considerations, APHIS has 

concluded there would be no changes in the direct or indirect effects on air quality from the 

preferred 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 

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 

60
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 from agriculture account for an estimated 69% of all U.S. N2O emissions (USEPA, 2011c). 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, 2011c). 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 by farm equipment as described 

previously in Subsection 2.2.4.

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; 

Farahbakhshazad et al., 2008; Halvorson et al., 2008; Philippe, 2008; Rochette et al., 2008; 

Almaraz et al., 2009; Poirier et al., 2009).

Baseline data for 1996-2004 for U.S. and Canadian canola production combined was used in one 

study to estimate it impact on GHG emissions (Brookes and Barfoot, 2004). They concluded 

that there was a reduction (94M kg of CO2) that resulted from reduced fuel usage attributable to 

61
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, 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 plant canola as a fall or winter forage (Kentucky-Department-of-Fish-andWildlife-Resources, 2010). Companies also market canola seed as an attractant to wildlife (ElkMound-Seed-Company, No date).

About half of the canola planted is glyphosate resistant. Glyphosate is practically nontoxic to

slightly toxic to birds, freshwater fish, marine and estuarine species, aquatic invertebrates and

mammals and practically nontoxic to honey bees (which are used to assess effects on nontarget

insects in general) (U.S. EPA, 1993). Glyphosate has a low octanol-water coefficient,

indicating that it has a tendency to remain in the water phase rather than move from the water

phase into fatty substances; therefore, it is not expected to accumulate in fish or other animal

tissues.

Preferred Alternative: Animal Communities

Compositional analyses were conducted to assess whether levels of key nutrients, toxicants and

anti-nutrients in MON 88302 were equivalent to levels in the conventional control and

commercial reference varieties. MON 88302 Canola is compositionally equivalent to other 

canola varieties currently available (Monsanto, 2011). . Based on the studies included in the 

petition, the physicochemical characteristics of the CP4 EPSPS protein expressed in MON

62
88302 Canola were determined and shown to be equivalent to those of an E. coli-produced

CP4 EPSPS protein that has been used in CP4 EPSPS protein safety studies. An assessment of

the potential of the CP4 EPSPS protein supports the conclusion that it does not pose any risk

to animals. Another indicator of safety is that the donor organism for the CP4 EPSPS coding

sequence, Agrobacterium sp. strain CP4, is ubiquitous in the environment and is not

commonly known to be an animal pathogen. Sequence analysis determined that CP4 EPSPS

protein does not share amino acid sequence similarities with known allergens, gliadins, glueinins 

or protein toxins. The CP4 EPSPS protein is rapidly digested in simulated digestive fluids and

demonstrates no oral toxicity in mice at the level tested. Therefore, the consumption of the

CP4 EPSPS protein from MON 88302 Canola or its progeny is considered safe for animals.

Management practices associated with MON88302 canola are similar to those of currently 

available canola varieties. Therefore there are no changes in practices that would effect animal 

communities.

Based on the findings of these studies APHIS has concluded that there are no changes in the 

effects on animal communities associated with the preferred alternative when compared to 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 complete 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

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 or 

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 10. 

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

Table 6) 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. For example, canola cannot be 

planted for 40 months following application of imazethapyr unless the canola is an 

imidazolinone-resistant variety.

63
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 

4). 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. 

North Dakota publishes a weed management guide10 that includes recommendations for weed 

management in canola.

Table 12. Herbicides and Application Methods1 Used in North Dakota Canola

Production

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)

10 http://www.ag.ndsu.edu/weeds/weed-control-guides/nd-weed-control-guide-1

64

 
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, 2012b). 

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: (weedscience.org, 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 B. rapa plants, decreasing the likelihood of crosspollination 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 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 

65
glyphosate drift, reducing the potential for transgene gene flow (Londo et 

al., 2010). 

The authors also indicated that additional study is needed to determine if these effects occur in 

the field.

Preferred Alternative: Plant Communities

Under the Preferred Alternative, as analyzed previously in Section 4.2.1, “Agricultural 

Production of Canola,” approval of MON 88302 Canola would allow greater latitude in the 

application rate of glyphosate in response to weed pressures. This would include making 

applications at twice the rate currently allowed for other currently-approved varieties of GR

canola. It would also allow for application of glyphosate at later developmental stages of canola 

crops until the onset of flowering.

APHIS has considered several offsetting concerns in analyzing these differences. The 

overarching one is that as part of its previous decisionmaking process for other GR crops (e.g., 

maize, soybeans, sugar beets), the Agency has prepared EAs (and/or EISs) and analyzed the 

potential effects of the higher glyphosate application rates now proposed for MON 88302 

(USDA-APHIS, 2000; USDA-APHIS, 2004; Rood, 2007; USDA-APHIS, 2010b; USDAAPHIS, 2012a).

The currently approved maximum application rate for glyphosate has also been evaluated by 

the USEPA. Glyphosate is a non-selective herbicide with post-emergence activity on

essentially all annual and perennial plants and has the potential to impact nontarget plants as a

result of runoff or spray drift (U.S. EPA, 1993). Regarding runoff, glyphosate binds strongly to

agricultural soils and has low potential to move offsite dissolved in water (U.S. EPA, 1993).

Moreover, glyphosate is not absorbed from agricultural soils by plants. During the reregistration process in 1993, additional data on terrestrial nontarget plants were requested by the

U.S. EPA. These additional data were utilized in conjunction with an exposure assessment

to further understand the potential risk to nontarget and threatened and endangered plants

from the use of glyphosate herbicides in agriculture. Using the methodology described in a 

recent U.S. EPA effects determination for glyphosate (U.S. EPA, 2009b), it was determined

that there is minimal risk to terrestrial plants that are not listed as threatened or endangered

from glyphosate. Therefore, there is no evidence that effects on plant communities from MON 

88302 Canola production will differ from those that occur in conjunction with other GR crops 

currently approved for production. 

A second concern is that although the frequency is low, MON 88302 Canola crosses with other 

mustard species (USDA-APHIS, 2012b). However, this frequency is the same as that for other 

commercially-grown GE canola MON 88302 Canola reached first flowering later than the

conventional control (61.1 vs. 56.2 days). However, the mean value of MON 88302 for days

to first flowering was within the natural variability of the commercial reference varieties

(45.9 – 67.5 days). Therefore, the difference in days to first flower is unlikely to effect the 

likelihood of outcrossing to other sexually compatible mustard species. Just as alleles from 

currently available canola varieties can introgress into other sexually compatible, co-localized 

mustard plants, this is also likely to happen with MON 88302 Canola. The phenotypic,

agronomic, and environmental interaction assessment of MON 88302 Canola was 

compared with the genetically similar conventional control. Observations were taken on

66
plants not treated with glyphosate in order to evaluate only the impact of the introduced trait

in MON 88302 Canola. Comparison to a range of commercial references established the range

of natural variability for canola. Characteristics assessed included: seed dormancy and

germination, pollen morphology, and plant phenotypic observations and environmental

interaction evaluations conducted in the field. Commercial references grown concurrently

were used to establish a range of natural variability for each assessed characteristic in

canola. The phenotypic, agronomic, and environmental interaction assessment demonstrated

that MON 88302 Canola is comparable to the conventional control (Monsanto, 2011), and 

therefore is an additional indication that MON 88302 Canola is unlikely to have increased

weediness or plant pest potential compared to conventional canola.

Seed dormancy and germination characterization indicated that MON 88302 seed had no 

changes in the dormancy or germination characteristics that could be indicative of increased

plant weediness or pest potential of MON 88302. Furthermore, no visual differences in

general pollen morphology were observed between MON 88302 and the conventional

control, demonstrating that the introduction of the glyphosate-tolerance trait did not alter

the overall morphology or pollen viability of MON 88302 compared to the conventional

control (Monsanto, 2011).

The field evaluation of phenotypic, agronomic, and environmental characteristics of MON

88302 Canola also supports the conclusion that it is not likely to have increased weediness or

plant pest potential or an altered environmental impact compared to conventional canola.

Assessments included 12 phenotypic and agronomic characteristics, as well as observations for

plant responses to abiotic stressors and plant-disease and plant-arthropod interactions. The

observed phenotypic characteristics were comparable between MON 88302 Canola and the

conventional control. Data show differences between MON 88302 Canola and the conventional

control for early stand count, seedling vigor, seed maturity, lodging, plant height, visual

rating for pod shattering, quantitative pod shattering, seed quality, yield, and final stand

count.

Therefore, no differences in hybridization effects are expected in the rate of introgression for 

MON 88302 Canola alleles into other sexually compatible mustards when compared to the 

currently available GR canola varieties.

Based on its analysis of the effects of these differences in the potential glyphosate-use patterns 

associated with MON 88302 Canola, APHIS has concluded that the changes in the effects on 

plant communities associated with the preferred alternative would be minimal, and could have an 

overall positive effect on reducing weed resistance when compared to the No-action Alternative.

4.4.4 Canola Seed Production

No Acton Alternative: Canola Seed Production

Under the No-Action Alternative, current canola seed production practices are not expected to 

change from continued regulation of MON 88302 Canola and its progeny under 7 CFR part 340 

and the plant pest provisions of the PPA. MON 88302 Canola would be cultivated for seed in a 

limited area independent of any commercial seed production. Field tests (Monsanto, 2011) have 

determined that MON 88302 Canola is not different from other canola cultivars, including nonGE and other GE-canola varieties, all of which are currently planted in the primary canolagrowing state of North Dakota (See Table 11). It is also expected that canola seed producers 

67
would continue to implement measures to preserve the identity of their seed varieties. No 

changes to canola seed production practices or locations would occur under the No-action 

Alternative.

Preferred Alternative: Canola Seed Production

Monsanto seed field trials have not demonstrated any agronomic or phenotypic differences 

between MON 88302 Canola and control canola cultivars (Monsanto, 2011). Under the 

preferred alternative with nonregulated status, MON 88302 Canola would likely replace some 

other commercial GR canola cultivars on current production acres.

Based on the data provided by Monsanto for MON 88302 Canola, as well as previous experience 

with other GE herbicide-resistant canola varieties that have been widely adopted by growers 

since their commercial availability in 1996, APHIS has concluded that the availability of MON 

88302 Canola under the Preferred Alternative would not alter the agronomic practices, 

cultivation locations, seed production practices or quality characteristics of conventional and 

non-GE canola seed production (Monsanto, 2011). No change to seed production practices 

would be required if MON 88302 Canola were no longer regulated. The potential impacts to 

canola seed production associated with the Preferred Alternative would be the same as the Noaction Alternative.

4.4.5 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). 

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 co68
evolved 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, 2010a; 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. After harvest, residue of MON 88302 Canola will 

remain at the site of cultivation. These crop residues will likely contain very small amounts of 

the novel CP4 EPSPS protein. This protein was developed by Agrobaterium-mediated 

transformation of canola hopocotyls (Monsanto, 2011). Agrobacterium sp. Is a common soilborne bacterium widespread in nature. 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 CP4 EPSPS protein with no 

likely effect on the soil. Therefore there should be no unique impacts on soil resulting from 

residue of MON 88302 Canola.

Approval of the petition would make available a new canola variety that has a higher in-crop 

glyphosate application rate (i.e., the total amount that can be applied annually to a crop) than that 

of other currently available GR canola varieties. The higher in-crop rate for MON 88302 Canola 

is however, less than or comparable to the in-crop rate currently allowed for GR sugar beets, 

alfalfa, corn, soybeans and cotton. Except for GR sugar beets, all of these are crops 

recommended in rotation with canola (Table 5), so fields used for GR canola plantings are 

already potentially subject to the higher in-crop glyphosate application rate. All of these GR 

crops cited here are no longer regulated by APHIS. As part of its decision-making process for 

these GR crops, APHIS prepared EAs (and/or EISs) and analyzed the potential effects on 

microorganisms associated with the higher glyphosate application rate now proposed for MON 

88302 (USDA-APHIS, 2000; USDA-APHIS, 2004; Rood, 2007; USDA-APHIS, 2010b; USDA69
APHIS, 2012a). EPA has also determined that use in accordance with the labeling of currently 

registered pesticide products containing glyphosate will not pose unreasonable risks or adverse 

effects to soil, including microorganisms, climate, air quality or water and water use. Based on 

these considerations, APHIS has concluded there would be no changes in the direct or indirect 

effects on microorganisms from the Preferred Alternative.

4.4.6 Biodiversity

No-action Alternative: Biodiversity 

All plants, animals and microorganisms interacting in an ecosystem contribute to biodiversity 

(Wilson, 1988a; Wilson, 1988b). 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.

70
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 

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 best management 

practices (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 determination of nonregulated status for MON 88302 Canola 

would provide growers with an additional GR variety. MON 88302 Canola is functionally the 

same as other GE- and non-GE-canola varieties with regard to agronomic and growth 

characteristics, growth form, reproductive trait, and utilization of resources. Because of these 

similarities, production practices will not change from those currently used for other GR-canola 

varieties. Therefore, a determination of nonregulated statusfor MON 88302 Canola is unlikely to 

have any direct effects on canola production practices, so there would be no change from the NoAction Alternative with regard to biodiversity.

Because MON 88302 Canola would only be another GR-canola option from those currently 

available, it would not promote expansion of canola acreage. Therefore, there is no indication of 

a potential impact on biodiversity from increased habitat loss through conversion of natural 

landscape to cropland. 

Based on the above information, APHIS has concluded that a determination of nonregulated 

status for MON 88302 Canola under the Preferred Alternative would not affect crop-, farm-, or 

landscape-scale biodiversity differently from that of the No-action Alternative.

4.5 Human Health

4.5.1 Consumer Health

No-action Alternative: Consumer Health 

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 proteins, and/or altered levels 

of existing allergens (Malarkey, 2003; Dona, 2009). Consumer exposure to canola is almost 

exclusively from canola products—not the plant or plant parts. Nearly all consumer exposure is 

from canola oil and sometimes meal. Both canola meal and canola oil are classified as GRAS by 

71
FDA (21 CFR 184). All currently available GE canola varieties have completed a consultation 

with FDA11. 

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 MON 88302 Canola, was completed by the FDA (BNF No. 127) on April 23, 

2012. 

Under the No-Action Alternative, agricultural production of non-regulated 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 

(US-EPA, 1993b). 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).The 1993 

glyphosate RED presents the data used by the EPA for chemical reregistration (see US-EPA, 

1993b).

A new review for reregistration began in July 2009. In conjunction with this process, EPA is 

currently conducting another comprehensive human health assessment for all uses of glyphosate 

and its salts (US-EPA, 2009b). 

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 cp4 epsps gene is derived from a soil bacterium Agrobacterium sp. The physicochemical

characteristics of the CP4 EPSPS protein expressed in MON 88302 Canola were determined

and shown to be equivalent to those of an E. coli-produced CP4 EPSPS protein that has 

been used in CP4 EPSPS protein safety studies. An assessment of the allergenic potential of the

CP4 EPSPS protein supports the conclusion that it does not pose any allergenic risk to

humans or animals. Another indicator of safety is that the donor organism for the CP4

EPSPS coding sequence, Agrobacterium sp. strain CP4, is ubiquitous in the environment and

is not commonly known to be a human or animal pathogen. Sequence analysis determined that 

11 See http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=bioListing for list of completed 

consultations.

72

 
CP4 EPSPS protein does not share amino acid sequence similarities with known allergens, 

gliadins, glueinins or protein toxins. The CP4 EPSPS protein is rapidly digested in simulated

digestive fluids and demonstrates no oral toxicity in mice at the level tested. Therefore, the

consumption of the CP4 EPSPS protein from MON 88302 Canola or its progeny is considered

safe for humans and animals.

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 MON 88302 Canola, was completed by the FDA (BNF No. 127) on April 23, 

2012. 

4.5.2 Worker Health

No-action Alternative: Worker Health

According to the NRC (National Research Council), adoption of GE crops has contributed to risk 

reduction associated with application of pesticides. This is attributed to a number of factors 

including reduced complexity and greater flexibility of farm management practices required for 

GE crops, which has allowed producers more opportunity to focus on worker safety (NRC, 

2004). Both producers and farm workers experience reduced exposure to potentially harmful 

pesticides in GE-cropping systems because of the reduction in the amount of time required for 

applying pesticides, and the greater flexibility allowed 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 the 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 

expected short-term dermal and inhalation exposures of occupational handlers and growers, no 

endpoints were identified by the EPA HED, so no occupational handler or occupational postapplication 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

73
Approval of the petition would make available a new canola variety that has a higher in-crop 

glyphosate application rate than that of other currently available GR canola varieties. The higher 

in-crop rate for MON 88302 Canola is however, less than or comparable to the in-crop rate 

currently allowed for GR sugar beets, alfalfa, corn, soybeans and cotton. All of these GR crops 

are no longer regulated by APHIS. As part of its decision-making process for these GR crops, 

APHIS prepared EAs (and/or EISs) and analyzed the potential risks to worker safety that might 

be associated with the higher glyphosate application rate now proposed for MON 88302 (USDAAPHIS, 2000; USDA-APHIS, 2004; USDA-APHIS, 2010b; USDA-APHIS, 2012a). EPA has 

also determined that use in accordance with the labeling of currently registered pesticide 

products containing glyphosate will not pose unreasonable risks or adverse workers who handle 

and apply pesticides. Based on these considerations, APHIS has concluded there would be no 

changes in the risks to worker safety from the Preferred 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). One disadvantage is its high 

level of sulfur (0.5% -1.3% on a 100% dry-matter basis), so the NRC recommends that total 

dietary sulfur not exceed 0.4% on a dry-matter basis. Another is that some producers have 

reported that cattle tend to develop scours, when fed canola hay or silage as the only source of

roughage (Atkinson et al., 2006).

Regulatory control of feed production by the FFDCA is similar to that for food for direct human 

consumption; 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. 

Most canola cultivated in the U.S. is grown mainly for vegetable oil and animal feed. Under the 

No-action Alternative, canola-based animal feed would be available from currently cultivated

varieties (Kandel, 2011), 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.

Preferred Alternative: Animal Feed

The acreage of canola production is not expected to change under the Preferred Alternative. 

Therefore, the only possible difference between the No-action Alternative and the Preferred 

Alternative is safety of MON 88302 Canola. To establish the absence of any significant 

differences in safety from non-regulated HR canola, Monsanto initiated a consultation process 

with FDA for the commercial distribution of MON 88302 Canola and submitted a safety and

74
nutritional assessment of food and feed derived from MON 88302 Canola to the FDA on March 

23, 2011. Based on the safety and nutritional assessment Monsanto conducted, FDA accepted 

Monsanto’s conclusion in a letter dated April 23, 2012. FDA stated:

“ food and feed derived from MON 88302 Canola are not materially 

different in composition, safety, and other relevant parameters from 

canola-derived food and feed currently on the market, and that the 

genetically engineered MON 88302 Canola does not raise issues that 

would require premarket review or approval by FDA. Based on the 

information Monsanto has presented to FDA, we have no further 

questions concerning food and feed derived from MON 88302 Canola

at this time. However, as you are aware, it is Monsanto’s continuing 

responsibility to ensure that foods marketed by the firm are safe, 

wholesome, and in compliance with all applicable legal and regulatory 

requirements.”

The introduced CP4 EPSPS proteins is unlikely to substantially affect the nutritional quality of 

canola meal derived from MON 88302 Canola. Previous GT canola demonstrated that it is not 

likely to have any significant impact on animal health and it has been approved by the three 

major federal regulatory agencies involved in regulating GE organisms: APHIS, the FDA, and 

US-EPA. There is no reason to suspect the new MON 88302 Canola would present a substantial 

risk to animal health. The CP4 EPSPS protein is equivalent to the protein expressed in 

commercial Roundup Ready crop products that are encoded by the cp4 epsps gene that confers 

tolerance to glyphosate-containing herbicides. Consequently, the quality of animal feed derived 

from MON 88302 Canola is unlikely to be substantially different than animal feed produced 

from current canola varieties. Therefore, APHIS concludes that impacts on animal feed from 

MON 88302 Canola if it is not regulated, the Preferred Alternative, would be the same as the 

No-action Alternative.

4.7 Socioeconomic Impacts

Canola agriculture can affect socioeconomic resources such as the domestic economy, 

international trade economy, and the social environment. This section describes key current issues 

within each of these topics.

4.7.1 Domestic production of canola

No-Action Alternative: Domestic Economic Environment

U.S. canola acreage increased during the period, 1990-2000. Since then, annual plantings have 

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 U.S. 

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. 

75
Production costs 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 

offset the potential increase.

Figure 7. U.S. Canola Acreage: 1991-2012

Source: (USDA-NASS, 2012b)

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 thousand acres increased 23% while the number of farms under 100 acres 

declined 33%. This trend in increasing farm size is not specific to canola.

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, MON 88302 Canola would likely be available to canola growers. 

The availability of MON 88302 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 MON 88302 

0

200,000

400,000

600,000

800,000

1,000,000

1,200,000

1,400,000

1,600,000

1,800,000

2,000,000

1991199219931994199519961997199819992000200120022003200420052006200720082009201020112012

CANOLA - ACRES PLANTED 

CANOLA - ACRES PLANTED

76
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.

Table 13. 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 23.30 214,77

4 

421,58

9 

297,07

5 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 23.30 238,93

2

471,55

3

357,55

3

1

U.S. dollars (USD);

2

In thousands of USD; 

3

Data not available

Source: (USDA-NASS, 2012b).

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, 

77
Michigan, New York, and Washington) (USDA-NASS, 2008a). 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 who grow organic products have expressed

concerns that cross-pollination between GE and organic varieties will affect the organic 

certification of their products (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 is achieved through implementation of the 

NOP regulations established under authority of the OFPA.

These regulations prohibit the use of excluded methods, which include 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.

Preferred Alternative

Availability of non-regulated MON 88302 Canola is not likely to influence the number of 

growers of organic canola, 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 in the U.S.). Total U.S. exports have averaged 

slightly more than 224 thousand metric tons. Figure 8 shows the changes in export quantities 

between 2007 and 2011.

 Table 14. Harvest and Value of Sales from Certified Organic Canola Farms in 2008

CANOLA, EDIBLE Harvested Value of Sales

78
(POUNDS) 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, 2008b), (USDA-NASS, 2012a).

The U.S. exported 150-300 thousand metric tons of canola each year during the period, 2007-

2011. U.S. canola exports go to Canada for processing in crushing plants, although shipments to 

Mexico have been increasing (USDA-ERS, 2001). U.S. imports of canola oil continue to 

increase steadily from 0.5M metric tons in 2000 to 1.2M metric tons in 2010. 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).

79
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

MON 88302 Canola is approved in Canada12, which is the recipient of most US canola exports. 

Therefore, approving the petition for nonregulated statusis not likely to change either U.S. or 

international canola trade. Imports and exports are driven by demand for canola oil. Most 

canola varieties planted in both the U.S. and Canada are HR. MON 88302 Canola is only 

expected to replace some acreage planted with other GR varieties. Based on these 

determinations, APHIS concludes that the impact of selecting the Preferred Alternative will not 

differ from that of those currently associated with the No-action Alternative. 

12

http://active.inspection.gc.ca/scripts/database/pntvcn_submitdb.asp?lang=e&crops=1&company=all&trait=all&even

ts=all

0

50000

100000

150000

200000

250000

300000

350000

2007 2008 2009 2010 2011

US Exports of Canola 

World

Canada

80

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

Total domestic production and U.S. canola seed imports are shown in millions of pounds. Most seeds 

are crushed for oil. Crushing plants use imported seed to supplement the domestic supply when 

making canola oil. U.S. canola seed imports comprise 25-50% of all seed crushed annually for oil 

(Source:(USDA-ERS, 2012a).

0

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000

2003/04 2004/05 2005/06 2006/07 2007/08 2008/09 2009/10 2010/11 2011/12

2/

Canola Seed Quantities in US 

Imports

Production

81
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 MON 88302 Canola to extend the range of canola

production and affect the conversion of land to agricultural purposes. Monsanto’s studies 

demonstrate that MON 88302 Canola is similar in its growth habit, agronomic properties, 

disease susceptibility to other non-regulated varieties of glyphosate-tolerant canola, and 

other GE and non-GE canola (Monsanto, 2011). 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 emphasized in Subsection 4.2, Acreage and Area of Canola 

Production, most canola cultivated in the U.S. is HR. If the petition is approved, MON 

88302 Canola could replace other commercially available GR-canola varieties without 

requiring cultivation of new, natural lands. Therefore, land use changes associated with 

approving the petition for nonregulated statusto MON 88302 Canola are not expected to be 

any different than those associated with the cultivation of other canola cultivars. Although 

the Preferred Alternative would allow for new plantings of MON 88302 Canola to occur 

anywhere in the U.S., APHIS focused its analysis of cumulative impacts on the areas in the U.S. 

that currently support canola production. 

Potential, reasonably foreseeable cumulative effects were analyzed under the assumption that 

canola producers have used in the past, and would continue to use reasonable, commonly 

accepted BMPs suitable for the cropping system and varieties they choose. APHIS recognizes, 

however, that not all farmers will use such BMPs. Thus, this circumstance was also considered 

in the cumulative impacts analysis.

Monsanto submitted a request for amended labeling to the U.S. EPA in February 2011 for

Registration Numbers 524-537 (Roundup WeatherMAX® Herbicide) and 524-549 (Roundup 

PowerMAX® Herbicide). The purpose of the request is to obtain a modification of the 

current use pattern for glyphosate on MON 88302 Canola. Although the amended labeling

increases the rate of application and widens the application period relative to canola

development, this use of glyphosate does not present any new environmental exposure 

consequences that have not been evaluated previously in conjunction with other Roundup

Ready crops which have already been deemed acceptable by the U.S. EPA (US-EPA, 1993). 

The application rate increase proposed for MON 88302 Canola is identical to the approved 

maximum application rate allowed for GE corn and soybean varieties that are no longer 

regulated by APHIS. These application rates have been evaluated previously by the Agency

(USDA-APHIS, 2000; USDA-APHIS, 2004; USDA-APHIS, 2010b; USDA-APHIS, 2012a) in 

other environmental assessments. 

82
According to the petitioner (Monsanto, 2011), MON 88302 Canola could be combined with 

another commercially available HR varietiety of in a stacked canola product, however, this is not

a reasonably foreseeable future action (USDA, 2013a).

5.2 Past and Present Actions 

In the preceding analysis, the potential impacts from approving the petition for nonregulated 

statusof MON 88302 Canola were assessed. The agronomic characteristics evaluated for MON 

88302 Canola encompassed the entire life cycle of the canola plant and included germination, 

seedling emergence, growth habit, vegetative vigor, days to pollen shed, days to maturity, and 

yield parameters. The compositional analysis included the major constituents (carbohydrates, 

protein, fat, and ash), minerals, vitamins, amino acids, fatty acids, secondary metabolites, 

antinutrients, phytosterols, and nutritional impact. MON 88302 Canola is agronomically and 

compositionally similar to its other GE- and non-GE-canola varieties (Monsanto, 2011; USDAAPHIS, 2013c). As a result, the potential impacts under the Preferred Alternative for all the 

resource areas analyzed are the same as those described for the No-action Alternative. 

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, Agricultural Production of Canola , and 4.2.3, Canola Seed 

Production). The majority of canola grown in the U.S. is GE and HR. Because MON 88302 

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 that MON 88302 Canola would replace other similar cultivars without 

expanding the acreage or area of canola production. Canola acreage may expand over time, but 

that expansion is driven by canola demand.

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 Market 

for Canola). As described above, the majority of canola is GE and HR. Since 1994, seven GEcanola 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, 2013c). 

U.S. organic canola production acreage is less than 500,000 acres. Because there are so few 

growers, more precise data are not publically available (see Table 14). Availability of another 

GE- GR-canola variety, such as MON 88302 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 MON 88302 Canola is not 

expected to result in changes to current canola cropping practices. Studies conducted by 

Monsanto demonstrate that, in terms of agronomic characteristics and cultivation practices, 

MON 88302 Canola is similar to other canola varieties currently grown (Monsanto, 2011), An 

independent analysis conducted by APHIS made the same conclusion (USDA-APHIS, 2013c). 

Therefore, no changes to current canola cropping practices such as tillage, crop rotation, or 

agricultural inputs associated with the adoption of MON 88302 Canola are expected (see Section 

4.2). 

Approving the petition for a determination of for MON 88302 Canola would have the same 

impacts to water, soil, air quality, and climate change as that of non-regulated GR canola

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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 MON 88302 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 non-regulated GR

canola and the fact that half of the cultivated canola in the U.S. is GR, adoption of MON 88302 

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. MON 

88302 Canola is both agronomically and compositionally similar to other non-regulated, GR

canola. Thus, it would not require any different agronomic practices to cultivate, and does not 

represent a safety or increased weediness risk different from other currently available GR canola. 

Availability of MON 88302 Canola would not impact the development of GR weeds or the trend 

to broaden weed management tactics to control HR weeds, because it is expected to replace other 

GR cultivars. 

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 for herbicides applied to 

MON 88302 Canola would not change from those already approved for other non-regulated GR

canola cultivars. The approved rates of application would increase, however, the increase would 

not exceed the rate currently approved for other crops such as corn and soybeans. The total 

amount of the mix of herbicides that could be applied to MON 88302 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. Registration 

requires that a pesticide must not cause unreasonable human health or environmental risks. 

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, 2013c)

MON 88302 Canola is similar to other glyphosate-tolerant canola varieties. The risk of gene 

flow and weediness of MON 88302 Canola is no greater than that of other non-regulated GRcanola 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 into the market to identify and discuss relevant safety, nutritional, or other regulatory 

issues regarding the bioengineered food. MON 88302 Canola is expected to have no toxic effect 

to human health or livestock. Monsanto submitted a safety and nutritional assessment for food 

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and feed derived from MON 88302 Canola and FDA accepted Monsanto’s conclusion in a letter 

dated April 23, 2012. The FDA decision has been posted to the FDA website13 for Final 

Biotechnology Consultations (BNF No. 127). The CP4 EPSPS protein is also expressed in soy 

and corn (see BNF 126). No change in food and feed safety is expected to occur under the 

Preferred Alternative.

Since MON 88302 Canola is GR, it would directly compete with the market share of other GRcanola varieties. Based on its similarity to other non-regulated canola cultivars, MON 88302 

Canola would likely replace other GR canola cultivars without impacting canola acreage or 

production areas that may affect domestic markets. Since MON 88302 Canola is also 

agronomically and compositionally similar to other commercially available canola, there 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. MON 

88302 Canola may give better in field weed control than the currently available GR canola 

varieties. However, it will not affect the treatment of HR weeds any differently than current 

methods used to effect control, so associated costs of current production methods and herbicide 

resistant weed-related crop losses would not change. Therefore, no changes to the domestic 

economic environment are expected to occur under the Preferred Alternative.

MON 88302 Canola is also not expected to affect the seed, feed, or food trade any differently 

than other non-regulated GR-canola varieties. Other countries already have access to GR canola

varieties and are important export competitors to U.S. canola trade. MON 88302 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 currently considering a petition for nonregulated status of a different GR canola 

variety, 73496 Canola. If APHIS approves that petition and MON 88302 Canola, there would 

potentially be two additional GR canola varieties marketed to growers. These two new varieties 

would likely compete in the marketplace for a share of the GR canola market. Factors such as 

the characteristics of the commercial varieties with which these events are bred, grower 

preferences, and price will determine how much of the market share these two new varieties 

replace. Therefore, the relative contribution of either of these events to total future canola 

production cannot be determined. 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 trait. If APHIS does not approve the petition for 73496 Canola, 

then these two events would not complete in the marketplace.

In 2012 the canola acreage planted was 65% greater than the canola acreage planted in the 

previous year. According to the NASS database, this was the most acreage planted with canola 

13 http://www.fda.gov/Food /Biotechnology/Submissions/ucm225108.htm

85

 
to date. Increased demand for oilseed (USDA-ERS, 2012b) and high canola prices (Ash, 2012a)

may have influenced the expanded acreage.

There is also an increasing interest in winter canola production in areas where winter wheat is 

grown. For example, in Oklahoma the acreage planted to canola has 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 

acreage planted with GR varieties. If MON 88302 Canola is bred into winter canola varieties, it 

may be adopted in this developing market. The use of glyphosate on MON 88302 Canola would 

change compared to the use on currently available varieties, but would be similar to that used on 

other glyphosate resistant crops such as soy and corn. While this higher rate could give better 

weed control in some situations, its overall effect on weed management in these winter canola 

growing areas will be minor.

In summary, the potential for impacts of MON 88302 Canola would not result in any changes to 

the resource areas when compared to the No A-action Alternative. No cumulative effects are 

expected from approving the petition for MON 88302 Canola, when taken in consideration of

related activities, including past, present, and reasonably foreseeable future actions. 

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6. THREATENED AND ENDANGERED SPECIES

Congress passed the Endangered Species Act (ESA) of 1973, as amended, is one of the most farreaching wildlife conservation laws ever enacted by any nation. Congress, on behalf of the 

American people, passed the ESA to prevent extinctions facing many species of fish, wildlife 

and plants. The purpose of the ESA is to conserve and preserve critical elements of America’s 

natural history heritage by conserving threatened and endangered species (TES), and the 

ecosystems they require for survival. The U. S. Fish and Wildlife Service (US-FWS) works in 

cooperation with the National Marine Fisheries Service (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. In its PPRA, 

USDA-APHIS has determined that Monsanto 88302 Canola does not pose a plant pest risk, so 

the Agency no longer has legal justification to regulate it under the plant pest provisions of the 

PPA described in 7 CFR §340. Therefore, APHIS has determined that the article is no longer 

regulated. As part of its EA analysis, the Agency analyzed the potential impacts of Monsanto 

88302 Canola on the environment, including those that might affect TES and critical habitat. As 

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part of this process, APHIS thoroughly reviewed the GE product information and data related to 

the organism (usually a plant species, but possibly another type of GE organism).

As described in Appendix A for each transgene/transgenic plant, USDA-APHIS analyzed 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 Monsanto 88302 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 System14. Prior to 

obtaining this list, APHIS also considered the potential for Monsanto 88302 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 MON 88302 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 nonGE canola (Monsanto, 2011; Pioneer, 2011). Since MON 88302 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 nonregulated status for MON 88302 Canola on TES and critical 

habitat in the areas where canola is currently grown.

14 ECOS; as accessed 4/15/2011 at http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrence.jspUS-FWS, 

Species Reports - Listings and Occurrences for Each State, 2011, Available: 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrence.jsp, May 25 2011.

88

 
APHIS focused its ESA effects analysis on the implications of exposure to the CP4 EPSPS 

protein in MON 88302 Canola, and the interaction between TES and the MON 88302 Canola 

plant, including potential for sexual compatibility and ability to serve as a host for 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 Monsanto 88302 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 MON 88302 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 

Monsanto 88302 Canola would directly affect any plant TES.

Monsanto has provided data in its petition indicating that compositionally, MON 88302 Canola

is equivalent to other canola varieties currently grown. There are no toxins or allergens 

associated with this plant. The CP4 EPSPS 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 Monsanto 

88302 Canola. 

In its PPRA, APHIS also evaluated MON 88302 Canola with particular emphasis on its 

weediness potential (USDA-APHIS, 2012b), 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, 2012b), which demonstrated that MON 88302

Canola is similar to other GR canola varieties. The risk of gene flow and weediness of MON 

88302 Canola is no greater than that of other non-regulated, GR-canola varieties, nor is there any 

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 MON 88302 Canola and the 

CP4 EPSPS protein will not affect any species, and MON 88302 Canola will not naturalize in

critical habitat. APHIS has concluded that approval of a petition for nonregulated status for 

MON 88302 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.

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 

89
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 Monsanto 88302 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 

Monsanto 88302 Canola or any GE organism, if the agency believes it may pose a plant pest 

risk. 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 Monsanto 88302 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 MON 88302

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 HR (Johnson et al., 2007). Approval of 

nonregulated status for MON 88302 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 MON 88302 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 MON 88302 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. 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 completed 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 

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 

90
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 

CP4 EPSPS protein establish the safety of MON 88302 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 non-regulated MON 88302 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 

MON 88302 Canola at the proposed application rates would be no more than that currently 

approved for other non-regulated 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 

would monitor the use of MON 88302 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 MON 88302

Canola is not expected to have a disproportionate adverse effect on minorities, low-income 

populations, or children.

The following executive order addresses Federal responsibilities regarding the introduction and 

effects of invasive species:

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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, 2012b) and MON 88302 

Canola is similar to other GR-canola varieties. The risk of gene flow and weediness of MON 

88302 Canola is no greater than that of other non-regulated, 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 EPA level of 

concern (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 MON 88302 Canola would have a negative effect 

on migratory bird populations because its introduction would not alter current glyphosateuse 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 MON 88302 

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 MON 88302 Canola subsequent to a determination of nonregulated 

status of the product would be fully subject to national phytosanitary requirements and be in 

accordance with phytosanitary standards (IPPC, 2010) developed under the International Plant 

Protection Convention (IPPC). 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 

93
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 those within NAPPO, which includes Mexico, 

Canada, and the U.S., and those within the OECD. NAPPO has completed three modules of the 

Regional Standards for Phytosanitary Measures No. 14: Importation and Release into the 

Environment of Transgenic Plants in NAPPO Member Countries (NAPPO, 2009).

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.

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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 MON 88302 Canola (see Subsection, 4.2, 

Agricultural Production of Canola) and determined that the cultivation of MON 88302 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 MON 88302 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 4.3.3, 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 MON 88302 Canola production. Based on these 

analyses, APHIS concludes that an extension of a determination of nonregulated status to MON 

88302 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 MON 88302 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.

Monsanto has presented results of agronomic field trials for MON 88302 Canola that 

demonstrate there are no differences in agronomic practices between MON 88302 Canola and 

currently available GR-canola varieties. The common agricultural practices that would be 

carried out in the cultivation of MON 88302 Canola are not expected to deviate from current 

practices, including the use of EPA-registered 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 MON 88302 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 MON 88302

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 MON 

88302 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

MON 88302 Canola is not likely to result in changes to the use of glyphosate on canola, 

including 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 

95
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 California red-legged frog 

(CRLF) is underway (US-EPA, 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 evolusionarily significant units (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 MON 88302 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.

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. 

96
The APHIS proposed action of a determination of nonregulated status of MON 88302 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 MON 88302 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 MON 88302 Canola is not expected to change any 

of these agronomic practices that would result in an adverse impact under the NHPA.

97
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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., Chief, Biotechnology Environmental Analysis Branch,

Environmental Risk Analysis Program

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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 

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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 

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 plant15

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 

toxins16)?

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)17?

5. Does the pest resistance18 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;

15 APHIS will provide USFWS a draft EA that addresses the impacts, if any, of gene movement 

to the threatened or endangered plant.

16 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.

17 Such phenotypes might include tolerance to environmental stress such as drought, salt, frost, 

and aluminum or heavy metals.

18 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.

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iii. By creating a deficiency in the host of a component required for growth of the pest (such 

as with fungi and bacteria);

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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