i

Monsanto Petition (09-SY-2000U) for Determination

of Non-regulated Status of (MON 87769) Stearidonic 

Acid Soybean

OECD Unique Identifier: 

MON 87769-7

Final Environmental Assessment 

April 2012

Agency Contact 

Cindy Eck

Biotechnology Regulatory Services

4700 River Road

USDA, APHIS 

Riverdale, MD 20737 

Fax: (301) 734-8669

The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of 

race, color, national origin, sex, religion, age, disability, political beliefs, sexual orientation, or marital or family status. 

(Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for 

communication of program information (Braille, large print, audiotape, etc.) should contact USDA’S TARGET Center 

at (202) 720–2600 (voice and TDD). 

To file a complaint of discrimination, write USDA, Director, Office of Civil Rights, Room 326–W, Whitten Building, 1400 

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

opportunity provider and employer. 

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

U.S. Department of Agriculture over others not mentioned. USDA neither guarantees nor warrants the standard of any 

product mentioned. Product names are mentioned solely to report factually on available data and to provide specific 

information. 

This publication reports research involving pesticides. All uses of pesticides must be registered by appropriate State 

and/or Federal agencies before they can be recommended. 
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TABLE OF CONTENTS

LIST OF TABLES...........................................................................................................VII

LIST OF FIGURES .........................................................................................................VII

ACRONYMS AND ABBREVIATIONS...................................................................... VIII

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

1.1 Regulatory Authority............................................................................................ 1

1.2 Regulated Organisms ........................................................................................... 2

1.3 Petition for Determination of Nonregulated Status: MON 87769 Soybean......... 2

1.4 Purpose of Product ............................................................................................... 3

1.5 APHIS Response to Petition for Nonregulated Status......................................... 5

1.6 Coordinated Framework Review ......................................................................... 6

1.6.1 U.S. Environmental Protection Agency........................................................ 6

1.6.2 Food and Drug Administration ..................................................................... 6

1.7 Public Involvement .............................................................................................. 7

1.8 Issues Considered................................................................................................. 7

2 AFFECTED ENVIRONMENT.................................................................................. 9

2.1 Soybean Products and Composition..................................................................... 9

2.1.1 Soybean Use.................................................................................................. 9

2.1.2 Soybean Composition ................................................................................. 12

2.2 Agricultural Production of Soybean................................................................... 13

2.2.1 Acreage and Area of Soybean Production.................................................. 13

2.2.2 Agronomic Practices................................................................................... 16

2.2.3 Soybean Seed Production ........................................................................... 23

2.2.4 Organic Soybean Production ...................................................................... 24

2.2.5 Specialty Soybean Production .................................................................... 26

2.3 Physical Environment ........................................................................................ 30

2.3.1 Water Resources ......................................................................................... 30

2.3.2 Soil Quality................................................................................................. 32

2.3.3 Air Quality .................................................................................................. 34

2.3.4 Climate Change........................................................................................... 37

2.4 Biological Resources.......................................................................................... 39

2.4.1 Animal Communities.................................................................................. 39
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2.4.2 Plant Communities...................................................................................... 40

2.4.3 Gene Flow and Weediness.......................................................................... 41

2.4.4 Microorganisms .......................................................................................... 43

2.4.5 Biodiversity................................................................................................. 44

2.5 Human Health .................................................................................................... 47

2.5.1 Public Health............................................................................................... 47

2.5.2 Human Dietary Health ................................................................................ 48

2.5.3 Worker Safety ............................................................................................. 50

2.6 Animal Feed ....................................................................................................... 51

2.7 Socioeconomic ................................................................................................... 51

2.7.1 Domestic Economic Environment .............................................................. 51

2.7.2 Trade Economic Environment .................................................................... 56

2.7.3 Social Environment..................................................................................... 57

3 ALTERNATIVES..................................................................................................... 59

3.1 No Action Alternative: Continuation as a Regulated Article............................. 59

3.2 Preferred Alternative: Determination that MON 87769 Soybean is No Longer a 

Regulated Article ............................................................................................... 59

3.3 Alternatives Considered But Rejected from Further Consideration .................. 60

3.3.1 Prohibit Any MON 87769 from Being Released........................................ 60

3.3.2 Approve the Petition in Part........................................................................ 60

3.3.3 Isolation Distance between MON 87769 Soybean and Non-GE Soybean 

Production and Geographical Restrictions................................................. 61

3.3.4 Requirement of Testing for MON 87769 Soybean..................................... 61

3.4 Comparison of Alternatives ............................................................................... 62

4 ENVIRONMENTAL CONSEQUENCES ............................................................... 64

4.1 Scope of the Analysis......................................................................................... 64

4.2 Agricultural Production of Soybean................................................................... 65

4.2.1 Acreage and Area of Soybean Production.................................................. 65

4.2.2 Agronomic Practices................................................................................... 67

4.2.3 Soybean Seed Production ........................................................................... 69

4.2.4 Organic Soybean Production ...................................................................... 69

4.2.5 Specialty Soybean Production .................................................................... 71
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4.3 Physical Environment ........................................................................................ 72

4.3.1 Water Resources ......................................................................................... 72

4.3.2 Soil Quality................................................................................................. 72

4.3.3 Air Quality .................................................................................................. 73

4.3.4 Climate Change........................................................................................... 74

4.4 Biological Resources.......................................................................................... 74

4.4.1 Animal Communities.................................................................................. 74

4.4.2 Plant Communities...................................................................................... 77

4.4.3 Gene Flow and Weediness.......................................................................... 77

4.4.4 Microorganisms .......................................................................................... 80

4.4.5 Biodiversity................................................................................................. 81

4.5 Human Health .................................................................................................... 82

4.5.1 No Action Alternative................................................................................. 82

4.5.2 Preferred Alternative: Human Health ......................................................... 83

4.6 Animal Feed ....................................................................................................... 86

4.6.1 No Action Alternative: Animal Feed.......................................................... 86

4.6.2 Preferred Alternative: Animal Feed............................................................ 87

4.7 Socioeconomic Impacts...................................................................................... 87

4.7.1 Domestic Economic Environment .............................................................. 87

4.7.2 Trade Economic Environment .................................................................... 93

4.7.3 Social Environment..................................................................................... 95

5 CUMULATIVE IMPACTS...................................................................................... 98

5.1 Assumptions Used for Cumulative Impacts Analysis........................................ 98

5.2 Cumulative Impacts: Acreage and Area of Soybean Production....................... 98

5.3 Cumulative Impacts: Agronomic Practices........................................................ 99

5.4 Cumulative Impacts: Soybean Seed Production .............................................. 101

5.5 Cumulative Impacts: Organic Soybean Production ......................................... 101

5.6 Cumulative Impacts: Specialty Soybean Production ....................................... 101

5.7 Cumulative Impacts: Water Resources............................................................ 101

5.8 Cumulative Impacts: Soil Quality.................................................................... 102

5.9 Cumulative Impacts: Air Quality ..................................................................... 103

5.10 Cumulative Impacts: Climate Change.............................................................. 103
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5.11 Cumulative Impacts Animal Communities...................................................... 103

5.12 Cumulative Impacts: Plant Communities......................................................... 103

5.13 Cumulative Impacts: Gene Flow and Weediness............................................. 104

5.14 Cumulative Impacts: Microorganisms............................................................. 104

5.15 Cumulative Impacts: Biodiversity.................................................................... 105

5.16 Cumulative Impacts: Human Health................................................................ 106

5.16.1 Cumulative Impacts: Worker Safety......................................................... 106

5.16.2 Cumulative Impacts: Public Health .......................................................... 106

5.17 Cumulative Impacts: Animal Feed................................................................... 107

5.18 Cumulative Impacts: Domestic Economic Environment................................. 108

5.19 Cumulative Impacts: Trade Economic Environment....................................... 109

5.20 Cumulative Impacts: Social Environment........................................................ 109

6 THREATENED AND ENDANGERED SPECIES ............................................... 111

6.1 Cumulative Impacts of Stacking MON 87769 Soybean with a Glyphosate Tolerant Trait 

on TES ............................................................................................................. 113

7 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AN D TREATIES 

RELATING TO ENVIRONMENTAL IMPACTS ............................................... 116

7.1 Executive Orders with Domestic Implications................................................. 116

7.2 Compliance with Clean Water Act and Clean Air Act .................................... 119

7.3 Impacts on Unique Characteristics of Geographic Areas ................................ 119

7.4 National Historic Preservation Act (NHPA) of 1966 as Amended.................. 120

8 REFERENCES ....................................................................................................... 121

9 APPENDIX A: FDA SUSBSTANCES GENERALLY RECOGNIZED AS SAFE (GRAS) 

– AGENCY RESPONSE LETTER GRAS NOTICE NO. GRN 000283 ............. 146

10 APPENDIX B: APHIS THREATENED AND ENDANGERED SPECIES DECISION

TREE FOR FWS CONSULTATIONS ................................................................. 152

11 APPENDIX C: PETITION FOR THE DETERMINATION OF NONREGULATED 

STATUS FOR MON 87769 – ADDENDUM: POTENTIAL MARKET IMPACT OF 

MON 87769 ........................................................................................................... 155

12 LIST OF PREPARERS........................................................................................... 183
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LIST OF TABLES

Table 1: Fatty acid composition of conventional soybean oil. .........................................11

Table 2: U.S. soybean production in Northern Tier states in 2010...................................16

Table 3: Rank of soybean production in Northern Tier states and the U.S. in 2007 

along with other principal crops. ........................................................................16

Table 4: First and second most frequent rotational crops following soybean. .................20

Table 5: Principle herbicides used in soybean production and percentage of acres 

applied--selected states. ......................................................................................23

Table 6: Certified organic soybean acreage, 2007 and 2008 ............................................26

Table 7: Irrigation of soybean acres in Northern Tier states ............................................30

Table 8: Water sources used for irrigation of soybean acres in Northern Tier states.......31

Table 9: Percentages of linoleic and linolenic acid in various vegetable oil sources 

and U.S. consumption.........................................................................................48

Table 10: Properties of select fatty acids...........................................................................53

Table 11: Industrial soybean products 2009 ......................................................................56

Table 12: World soybean products 2009 ...........................................................................57

Table 13: Summary of issues of potential impacts and consequences of alternatives.......62

Table 14: Comparison of fatty acid profiles for oil derived from MON 87769 soybean

with several other oil sources..............................................................................75

Table 15: Comparison of percentage fatty acid in MON 87769 soybean with 

conventinal control (A3535) and commercial range ..........................................84

Table 16: U.S. vegetable oil prices..................................................................................109

LIST OF FIGURES

Figure 1: Pathways for the synthesis of EPA and DHA from Linoleic and alphaLinolenic Acid ......................................................................................................4

Figure 2: Fatty acid biosynthesis in plants and the introduced changes in MON 87769 

soybean .................................................................................................................5
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ACRONYMS AND ABBREVIATIONS

AIA advanced informed agreement

ALA alpha-linolenic acid

ALS Acetolactate Synthase

AOSCA Association of Official Seed Certifying Agencies

APHIS Animal and Plant Health Inspection Service

BRS Biotechnology Regulatory Services (within USDA–APHIS)

Bt Bacillus thuringiensis protein

CAA Clean Air Act

CBD Convention on Biological Diversity

CFR Code of Federal Regulations (United States)

CH4 methane

CLSS closed loop stewardship system

CO carbon monoxide

CO2 carbon dioxide

CT conservation tillage

DNA deoxyribonucleic acid

DHA docosahexaenoic acid

EA environmental assessment

E. coli Escherichia coli

ECOS Environmental Conservation Online System (USFWS)

EIS environmental impact statement

EO Executive Order

EPA eicosapentaenoic acid

EPSPS 5- enolpyruvylshikimate-3-phosphate synthase

ESA Endangered Species Act of 1973

EU European Union

FDA U.S. Food and Drug Administration 

FFDCA Federal Food, Drug, and Cosmetic Act

FFP food, feed, or processing

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FR Federal Register
ix

g/kg grams per kilogram

GE genetically engineered

GHG greenhouse gas

GLA gamma-linolenic acid

GMO genetically modified organism

GRAS generally recognized as safe

HDL high-density lipoprotein

IP Identity Preservation

IPCC Intergovernmental Panel on Climate Change

ISPM International Standard for Phytosanitary Measure

IPPC International Plant Protection Convention

ISO International Organization for Standards

LA linoleic acid

lb(s) pound(s)

LDL low-density lipoprotein

LMO Living Modified Organism

m meters

MG maturity group

mg milligrams

NO2 nitrogen dioxide

N2O nitrous oxide

NAAQS National Ambient Air Quality Standards

NABI North American Biotechnology Initiative

NAPPO North American Plant Protection Organization

Nc.Fad3 Neurospora crassa ∆15 desaturase gene

NEPA National Environmental Policy Act of 1969 and subsequent amendments

NHPA National Historic Preservation Act

NMFS National Marine and Fisheries Service

NOP National Organic Program

NPS non-point source

NRC National Research Council

O3 ozone
x

OECD Organization for Economic Cooperation and Development

PIPs plant incorporated protectants

Pj.D6D Primula juliae ∆6 desaturase gene

PM2.5 particulate matter with an aerodynamic diameter less than or equal to 2.5 

micrometers

PM10 particulate matter with an aerodynamic diameter less than or equal to 10 

micrometers

POEA polyethoxylated alkyl amine

PPRA Plant Pest Risk Assessment

PPA Plant Protection Act

PRA Pest Risk Analysis

RNA ribonucleic acid

SDA stearidonic acid

SO2 sulfur dioxide

STS sulfonylurea soybeans

TES threatened and endangered species

TSCA Toxic Substances Control Act

U.S. United States

USC United States Code

USDA U.S. Department of Agriculture

USDA-AMS U.S. Department of Agriculture-American marketing Service

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

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

U.S. EPA U.S. Environmental Protection Agency

USFWS U.S. Fish and Wildlife Services

VOC volatile organic compound

WPS Worker Protection Standard for Agricultural Pesticides

μm micrometers

°F degrees Fahrenheit
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1 PURPOSE AND NEED

1.1 Regulatory Authority

"Protecting American agriculture" is the basic charge of the United States Department of 

Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS). APHIS provides 

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

agricultural productivity and competitiveness, and contributes to the national economy and the 

public health. USDA asserts that all methods of agricultural production (non-GE, organic, or the 

use of genetically engineered varieties) can provide benefits to the environment, consumers, and 

farm income. 

Since 1986, the United States (U.S.) government has regulated genetically engineered (GE) 

organisms pursuant to a regulatory framework known as the Coordinated Framework for the 

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

Coordinated Framework, published by the Office of Science and Technology Policy, describes 

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

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

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

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

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

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

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

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

there is evidence of “unreasonable” risk. 

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

agencies involved in regulating GE organisms: USDA’s Animal and Plant Health Inspection 

Service (APHIS), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental 

Protection Agency (U.S. EPA). 

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

the Plant Protection Act of 2000, as amended (7 USC § 7701 et seq.) to ensure that they do not 

pose a plant pest risk to the environment.

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

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

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

laws, FDA encourages them to participate in a voluntary consultation process. All food and feed 

derived from GE crops currently on the market in the United States have successfully completed 

this consultation process. The FDA policy statement concerning regulation of products derived 

from new plant varieties, including those genetically engineered, was published in the Federal 

Register (FR) on May 29, 1992 (57 FR 22984-23005). Under this policy, FDA uses what is 

termed a consultation process to ensure that human food and animal feed safety issues or other 

regulatory issues (e.g., labeling) are resolved prior to commercial distribution of bioengineered 

food.
2

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

Fungicide, and Rodenticide Act (FIFRA). U.S. EPA also sets tolerance limits for residues of 

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

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

biological control organisms under the Toxic Substances Control Act (TSCA). The U.S. 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. Because the genes 

expressed in MON 87769 are not pesticidal, they are not subject to these EPA regulations.

1.2 Regulated Organisms

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

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

allows for the safe development and use of GE organisms. APHIS regulations at 7 Code of 

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

the Plant Protection Act, as amended (7 United States Code (U.S.C.) 7701–7772), regulate the 

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

organisms and products. A GE organism is no longer subject to the plant pest provisions of the 

Plant Protection Act or to the regulatory requirements of 7 CFR part 340 when APHIS 

determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated 

article if the donor organism, recipient organism, vector, or vector agent used in engineering the 

organism belongs to one of the taxa listed in the regulation (7 CFR 340.2) and is also considered 

a plant pest. A GE organism is also regulated under part 340 when APHIS has reason to believe 

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

the GE organism is unlikely to pose a plant pest risk.

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

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

Protection Act or the regulations at 7 CFR 340. Under § 340.6(c)(4), the petitioner is required to 

provide information 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 Plant Protection Act when APHIS determines that it is unlikely to pose a 

plant pest risk.

1.3 Petition for Determination of Nonregulated Status: MON 87769 Soybean

Monsanto Company of St. Louis, MO (Monsanto), submitted a petition (APHIS Number 09-183-

01p) to APHIS in 2009 seeking a determination of nonregulated status for Event MON 87769 

soybean that is engineered to express high levels of the fatty acid stearidonic acid (SDA) in 

soybean seed. As detailed in the petition, smaller amounts of three other fatty acids are produced 

in addition to the SDA, and expression of linoleic acid is reduced (Monsanto, 2010b). In the 

event of a determination of nonregulated status, the nonregulated status for MON 87769 soybean 

would include MON 87769 soybean, any progeny derived from crosses between MON 87769 

soybean and conventional soybean, and crosses of MON 87769 soybean with other 

biotechnology-derived soybean that have been determined to be no longer subject to the 
3

requirements of Part 340 or the plant pest provisions of the Plant Protection Act. MON 87769 

soybean is currently regulated under 7 CFR part 340.

Interstate movements and field trials of MON 87769 soybean have been conducted under permits 

issued or notifications acknowledged by APHIS from 2003 through 2008. Data resulting from 

these field trials are described in the petition (Monsanto, 2010b). Notifications acknowledged 

and permits issued by APHIS are listed in the petition (Monsanto, 2010b). The test sites 

represent diverse regions of the U.S., including the major growing areas of the Midwest 

(Wisconsin, Michigan, Minnesota Missouri, Iowa, Illinois, Indiana, Kansas, Kentucky, 

Nebraska, South Dakota, Pennsylvania, Ohio, and Arkansas), and winter nurseries in Puerto Rico 

and Hawaii. Field tests conducted under APHIS oversight allow for evaluation in agricultural 

settings under confinement measures designed to minimize the likelihood of persistence in the 

environment after completion of the field trial. Under confined field trial conditions, data are 

gathered on multiple parameters and used by applicants to evaluate agronomic characteristics 

and product performance. These data are also valuable to APHIS for assessing the potential for a 

new variety to pose a plant pest risk. The data evaluated for MON 87769 soybean may be found 

in the APHIS Plant Pest Risk Assessment (PPRA) (USDA-APHIS, 2010c).

1.4 Purpose of Product

Monsanto seeks a determination of nonregulated status of MON 87769 soybean, a specialty trait 

soybean characterized by a fatty acid profile containing SDA, an omega-3 fatty acid, which is 

not found in conventional soybean. SDA (an 18-carbon fatty acid with four double bonds or

18:4) is metabolically converted in humans to eicosapentaenoic acid (EPA; 20:5) and 

docosahexaenoic acid (DHA; 22:6), both of which may be involved in promoting heart health 

and other physiologically healthful conditions. These fatty acids may commonly be derived 

from fish oils, but a soybean source containing SDA that provides a precursor to these would be 

more efficiently produced in human nutrition. Since SDA has fewer double bonds than the 

omega-3 fatty acids, EPA (20:5) or DHA (22:6), SDA soybean oil is more stable to oxidation 

(i.e., less prone to fishy or rancid odors and taste) than fish oils, thereby expanding the potential 

formulation options for food companies and food products for consumers. The biosynthetic 

pathways for interconversions of the linoleic, linolenic and SDA to EPA and DHA are shown in 

Figure 1.

SDA production in MON 87769 soybean is accomplished by inserting two desaturase genes, 

Primula juliae Δ6 desaturase (Pj.D6D) and Neurospora crassa Δ15 desaturase (Nc.Fad3), into a 

conventional soybean variety. The Pj∆6D and Nc∆15D proteins found in MON 87769 soybean

also produce gamma-linolenic acid (GLA), another fatty acid not in conventional soybean. In 

MON 87769, the NcΔ15D protein converts linoleic acid (LA) to alpha-linolenic acid (ALA) and 

the protein PjΔ6D converts the ALA to SDA and LA to gamma linolenic acid (GLA) (Monsanto, 

2010b). Figure 2 shows the existing pathways by which desaturases form fatty acids in 

conventional soybeans and how the pathways are altered when the two desaturase genes, 

Primula juliae Δ6 desaturase (Pj.D6D) and Neurospora crassa Δ15 desaturase (Nc.Fad3)

inserted into MON 87769 soybean form fatty acids.
4

Source: Source: 

(Council for Responsible Nutrition, 2005).

Figure 1. Pathways for the synthesis of EPA and DHA from Linoleic and alpha-Linolenic 

Acid.

MON 87769 soybean would not be grown for the commodity soybean market; instead, it is 

anticipated that a specialty soybean oil from MON 87769 soybean would be produced. 

Compared to commodity soybean oil, SDA soybean oil contains two additional fatty acids, SDA 

and GLA. SDA omega-3 soybean oil produced from MON 87769 soybean contains 

approximately 20 to 30% SDA (weight percent of total fatty acids), 5 to 8% gamma-linolenic 

acid (GLA), and slightly higher levels of alpha-linolenic acid (ALA) and palmitic acid than in 

conventional soybean oil (Monsanto, 2010b). It also contains lower levels of oleic acid and 

linoleic acid (LA) than those present in conventional soybean oil. Since oleic acid, linoleic acid, 

and alpha-linolenic acid are directly involved in the pathway to SDA, their concentrations are 

inter-related with those of other fatty acids and, therefore, were expected to be different in MON 

87769 soybean seed.
5

Figure 2. Fatty acid biosynthesis in plants and the introduced changes in MON 87769 

soybean

SDA omega-3 soybean oil produced from MON 87769 soybean can be included in a range of 

food products for health benefits. The use of SDA soybean oil in selected food categories could 

provide a wide range of dietary alternatives for increasing human omega-3 fatty acid intake. 

SDA soybean oil is intended for use in a variety of food products including baked goods and 

baking mixes, breakfast cereals and grains, cheeses, dairy product analogs, fats and oils, fish 

products, frozen dairy desserts and mixes, grain products and pastas, gravies and sauces, meat 

products, milk products, nuts and nut products, poultry products, processed fruit juices, 

processed vegetable products, puddings and fillings, snack foods, soft candy, and soups and soup 

mixes at levels that will provide 375 milligrams (mg) SDA per serving. Fish and plant oils rich 

in omega-3 fatty acids also are used in feed applications such as aquaculture and poultry feeds. 

SDA soybean oil from MON 87769 soybean may eventually be used in aquaculture and feed 

applications as an alternative to fish oil and other omega-3 rich feed components.

It is anticipated that MON 87769 soybean will have low production acreage (< 5% of total U.S. 

soybean acreage or up to 3 to 3.5 million acres) in North America. In order to derive commercial 

value from this product, the SDA soybean crop will be grown a closed-loop production and 

marketing system in the soybean growing region of the Northern U.S (Monsanto, 2010b).

1.5 APHIS Response to Petition for Nonregulated Status

Under the authority of the plant pest provisions of the Plant Protection Act and 7 CFR part 340, 

APHIS has issued regulations for the safe development and use of GE organisms. As required 

by 7 CFR 340.6, APHIS must respond to petitioners that request a determination of the regulated 

status of genetically engineered organisms, including GE plants such as MON 87769 soybean. 

When a petition for nonregulated status is submitted, APHIS must make a determination if the 

genetically engineered organism is unlikely to pose a plant pest risk. If APHIS determines based 

on its PPRA that the genetically engineered organism is unlikely to pose a plant pest risk, the 

genetically engineered organism is no longer subject the plant pest provisions of the Plant 

Protection Act and 7 CFR part 340. 

18:0

stearic

acid

18:1

oleic

acid

Δ9 18:3

α-linolenic

acid

Δ12

2

18:3

γ-linolenic

acid

18:2

linoleic

Δ15

2

18:4

stearidonic acid

Δ6 Δ6

Δ15

Pathways where soybean’s existing desaturases form fatty acid

Pathways where desaturases introduced in MON 87769 form fatty acids
6

APHIS has prepared this environmental assessment (EA) to consider the potential environmental 

effects of an agency determination of nonregulated status consistent with Council of 

Environmental Quality’s National Environmental Policy Act (NEPA) regulations and the USDA 

and 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 environment1that may result from a determination of 

nonregulated status of MON 87769 soybean.

1.6 Coordinated Framework Review

1.6.1 U.S. Environmental Protection Agency

The U.S. EPA regulates plant-incorporated protectants (PIPs) under FIFRA (7 U.S.C. 136 et 

seq.) and certain biological control organisms under TSCA (15 U.S.C. 53 et seq.). MON 87769 

soybean does not express a pesticidal property, and, accordingly, is not regulated by the U.S. 

EPA.

1.6.2 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 that are GE, in the Federal Register on May 29, 1992 (57 FR 22984). 

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

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

commercial distribution of bioengineered food. 

MON 87769 soybean is within the scope of the FDA policy statement concerning regulation of 

products derived from new plant varieties, including those produced through genetic 

engineering. Monsanto initiated the consultation process with FDA for the commercial 

distribution of MON 87769 soybean and submitted a safety and nutritional assessment of food 

and feed derived from MON 87769 soybean to the FDA on March 23, 2009 (BNF No. 00117)

(Monsanto, 2010b). FDA is currently evaluating the submission.

FDA also administers the Generally Recognized as Safe (GRAS) Notification Program (USFDA, 2011). A substance that will be added to food is subject to premarket approval by FDA 

unless qualified experts determine its use is generally recognized as safe (GRAS). Under the 

GRAS program (62 FR 18938), a notification procedure is established whereby FDA is notified 

by a person that they have made a determination that a particular use of a substance is GRAS. 

FDA evaluates the submission to determine whether a sufficient basis for a GRAS determination 

has been provided or issues exist on whether use of the substance is GRAS. Monsanto submitted 

a GRAS Notice for SDA soybean oil (No. GRN 000283) to FDA on February 25, 2009 (USFDA, 2009b). FDA issued a response letter on September 4, 2009, indicating the agency has no 

further questions about the characteristics of the oil, and the safety of its use in foods (US-FDA, 

2009a).

 

1

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

relationship of people with that environment” (40 CFR §1508.14).
7

1.7 Public Involvement

APHIS routinely seeks public comment on draft EAs prepared in response to petitions for 

nonregulated status of GE organisms. APHIS does this through a notice published in the Federal 

Register. The issues discussed in this EA were developed by considering the public concerns as 

well as issues raised in public comments submitted for other EAs of GE organisms, concerns 

raised in lawsuits, as well as those issues of concern that have been raised by various 

stakeholders. These issues, including those regarding the agricultural production of soybeans

using various production methods and the environmental and food/feed safety of GE plants were 

addressed to analyze the potential environmental impacts of MON 87769 soybean.

This EA, the petition submitted by Monsanto, and APHIS’s PPRA will be available for public 

comment for a period of 60 days (7 CFR § 340.6(d)(2)). Comments received by the end of the 

60-day period will be analyzed and used to inform APHIS’ determination decision of the 

regulated status of MON 87769 soybean and to assist APHIS in determining whether an 

Environmental Impact Statement (EIS) is required prior to the determination decision of the 

regulated status of this soybean variety.

1.8 Issues Considered

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

experience in considering public concerns and issues raised in public comments submitted for 

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 

in the past. The resource areas considered in this EA can be categorized as follows: 

Agricultural Production Considerations:

 Acreage and Areas of Soybean Production

 Agronomic/Cropping Practices

 Soybean Seed Production

 Organic Soybean Production

 Specialty Soybean Production

Environmental Considerations:

 Water Resources

 Soil and Land Use

 Air Quality

 Climate Change

 Animals

 Plants

 Gene Flow

 Microorganisms

 Biological Diversity

Human Health Considerations:
8

 Public Health

 Worker Safety

Livestock Health Considerations:

 Livestock Health/Animal Feed

Socioeconomic Considerations:

 Domestic Economic Environment 

o Implications for Food Use

o Implications for Industrial Use

 Trade Economic Environment

 Social Environment
9

2 AFFECTED ENVIRONMENT

The Affected Environment section provides an overview of the use and composition of soybeans, 

followed by a discussion of the current conditions of those aspects of the human environment 

potentially impacted by a determination of nonregulated status of MON 87769 soybean. For the 

purposes of this draft EA, those aspects of the human environment are: soybean production 

practices, the physical environment, biological resources, human health, animal feed, and 

socioeconomic issues. Because production of MON 87769 soybean is expected to be limited by

actions taken by Monsanto, the affected environment assessed in this EA will primarily focus on 

those geographical areas where MON 87769 soybean would potentially be planted. As indicated 

by Monsanto, the area to which production will be limited includes the Northern Tier states of 

North and South Dakota, Minnesota, Wisconsin, and Michigan (Monsanto, 2010c) and a 

combination of geographically delimited seed sales, released maturity groups and soybean 

purchases, and contracts will provide a means to define the production area. 

2.1 Soybean Products and Composition

The soybean is an economically important leguminous crop providing oil and protein. Soybean 

plants are grown for their seed, which is further processed to yield oil for a variety of uses and 

meal for livestock feed and human dietary products. Soybean uses in the U.S. include edible 

soybean oil, soy-based biodiesel, animal feed, tofu, and industrial chemicals (SoyStats, 2010a). 

This subsection provides an overview of the various uses and associated composition of soybean.

2.1.1 Soybean Use

Approximately 50% of the world soybean seed supply in 2009 was crushed to produce soybean 

meal and oil (Soyatech, 2008). Most of the seed was used to supply the feed industry for 

livestock use or the food industry for edible vegetable oil and soybean protein products. Another 

34% of the world soybean seed supply was traded to other geographies, with China, the 

European Union (EU), Japan, and Mexico being the top soybean seed importers (SoyStats, 

2010h). The remainder of the soybean seed produced was used as certified seed, feed, or stocks.

Industrial uses of soybean range from a carbon/nitrogen source in the production of yeasts via 

fermentation to the manufacture of soaps, inks, paints, disinfectants, and biodiesel (see, e.g., 

(Cahoon, 2003); (SoyStats, 2010a)).

Soybean oil generally has a smaller contribution to soybean’s overall value compared to soybean 

meal because the oil constitutes just 18 to 19% of the soybean's weight. Nonetheless, soybean 

oil accounted for approximately 30% of all the vegetable oils consumed globally and was the 

second largest source of vegetable oil worldwide, slightly behind palm oil representing 

approximately 32% of global consumption (Soyatech, 2010). Soybean oil also has industrial 

applications, including feedstock in manufacture of inks, paints, varnishes, resins, plastics, and 

biodiesel ((Cahoon, 2003); (SoyStats, 2010a)). Soybean meal is used as a supplement in feed 

rations for livestock. Soybean meal is the world's most important protein feed, accounting for 

nearly 69% of world protein meal supplies (SoyStats, 2010f). 

Soybean is grown as a commercial crop in more than 40 countries (those with greater than 

10,000 hectares) (FAO, 2010). Processed soybeans supply the largest world source of protein 
10

animal feed and the second largest source of vegetable oil (USDA-ERS, 2010e). U.S. total 

oilseed production consists of more than 90% by weight of soybeans while the remainder is other 

oilseeds—such as cottonseed, sunflower seed, canola, and peanuts (USDA-ERS, 2010e).

Soybean Meal

Following solvent extraction of the oil, the remaining solid soybean flakes are toasted and 

ground to produce soybean meal (Soyatech, 2008). Soybean seed (at 13% moisture) with about 

18% oil will contain 34.6 to 36.7% protein, and the derived soybean meal will contain 47.5 to 

48.8 % protein by dry weight (Brumm and Hurburgh Jr, 2006). Only a small proportion (1%) of 

the soybean is consumed directly by humans as protein; most domestic soybean meal is used by 

the American livestock industry (USB, 2011a). The mixed rations for poultry, hogs, cattle, dairy

cows, domestic pets, and farmed fish often are formulated with soybean meal. In 2010, poultry

were the largest consumers of soybean meal (49%), followed by hogs (25%) and then cattle 

(12%) (Soystats, 2011a). Other animal consumers include farmed fish and domestic pets.

Soybean Oil

Soybean oil is used in a wide variety of food applications. Until 2005, soybean oil was the 

largest source of vegetable oil worldwide (USDA-ERS, 2010e). Since 2005, palm oil has 

overtaken soybean oil in volume of worldwide vegetable oil production (USDA-ERS, 2010e). 

Conventional soybean oil is composed of a mixture of fatty acids. Fatty acids are identified 

based on the number of carbons and the degree to which they are saturated. Table 1 presents the 

fatty acid composition of soybean. 

The five major fatty acids in conventional soybean oil are linoleic acid, oleic acid, palmitic acid, 

linolenic acid, and stearic acid (CODEX, 2010). Linoleic and linolenic are classified as 

polyunsaturated fatty acids, oleic acid is a monounsaturated fatty acid, and palmitic and stearic 

acids are saturated fatty acids (CODEX, 2010).

The physical and chemical properties of conventional soybean oil limit its use for many food 

and industrial applications (Cahoon, 2003). As noted in Table 1, untreated soybean oil has high 

concentrations of the linolenic and linoleic acids, both polyunsaturated fatty acids (US-FDA, 

1996). These polyunsaturated fatty acids are subject to oxidation, which affects flavor and 

product stability, and thus shortens its shelf life (US-FDA, 1996). To enhance stability, 

selective hydrogenation has been used to decrease the percentage of polyunsaturated fatty acids 

in the soy oil blend (US-FDA, 1996). The selective hydrogenation dramatically improves shelf 

life and provides stability during deep-frying and other high temperature applications

(Mozzaffarian et al., 2006). Although the hydrogenation process does increase the percentage of 

monounsaturated oleic acids, the hydrogenation process produces substantial quantities of the 

trans isomer of oleic acid. Such trans-fats have been identified as negatively impacting human 

cholesterol levels by raising the low-density lipoprotein (LDL) cholesterol and lowering the 

high-density lipoprotein (HDL) cholesterol. This association with trans-fatty acids has resulted 

in a decline in soybean oil consumption in the U.S. (USDA-ERS, 2006a).
11

Table 1. Fatty acid composition of conventional soybean oil.

Fatty Acid 

Lipid Number Fatty Acid Common Name

Percentage of 

Total Fatty Acid 

in Conventional 

Soybean Oil

C6:0* Caproic Acid ND

C8:0 Caprylic Acid ND

C10:0 Capric Acid (Decanoic) ND

C12:0 Lauric Acid ND – 0.1

C14:0 Myristic Acid (Tetradecanoic) ND – 0.2

C16:0 Palmitic Acid 8.0 – 13.5

C16:1 Palmitoleic Acid ND – 0.2

C17:0 Margaric Acid (Heptadecanoic) ND – 0.1

C17:1 Cis-10 Heptadecanoic Acid ND – 0.1

C18:0 Stearic Acid 2.0 – 5.4

C18:1 Oleic Acid 17 - 30

C18:2 Linoleic Acid 48 – 59

C18:3 Linolenic Acid 4.5 – 11

C20:0 Arachidic Acid (Eicosanoic) 0.1 – 0.6

C20:1 Eicosenoic Acid ND – 0.5

C20:2 Eicosadienoic Acid ND – 0.1

C22:0 Behenic Acid (Docosanoic) ND – 0.7

C22:1 Docosenoic Acid ND – 0.3

C22:2 Docosadienoic Acid ND

C24:0 Lignoceric Acid (Tetracosanoic) ND – 0.5

C24:1 Cis-tetracosenoic Acid ND

Source: (CODEX, 2010).

Notes: *Fatty acids are identified based on the number of carbon atoms and the number of double bonds in 

that fatty acid. Hence, oleic acid is identified as C18:1, indicating that this fatty acid is comprised of 18 

carbon atoms with a single double bond.

ND – Not detectable

Soybean Food Products

Soybean is used in various food products, including tofu, soybean sauce, soymilk, energy bars, 

and meat products. A significant fraction of the soybean market is dedicated to production of 

purified oil for food use and industrial applications (Cahoon, 2003). Food uses include 

margarines, shortenings, and cooking and salad oils (OECD, 2000).
12

2.1.2 Soybean Composition

Generally, soybean seed consists of oil (about 20%), protein (about 40%), carbohydrate (about 

35%), and ash (about 5%) (Liu, 1997)Various constituents have importance to the health and 

nutrition value of soybean, such as the isoflavonoids. Others are anti-nutritive, and many of 

these can be eliminated by the routine heating of the protein or meal fraction during processing 

for animals or humans. The oil fraction is composed of triglycerides with associated fatty acids, 

whose profile has significant consequences for human health and nutrition. The protein fraction 

is the most valued part of the soybean, and represents a complete protein that is important in 

human diets and feeding of livestock, poultry and farmed fish. The carbohydrate fraction of 

soybean flours can include both nutritive sugars (glucose, sucrose, galactose and others) and 

those that cannot be processed by human digestive enzymes (raffinose, stachyose) (see (Eldridge 

et al., 1979)).

Protein

Soybean is considered to be a source of complete protein. A complete protein is one that 

contains significant amounts of all the essential amino acids that must be provided to the human 

body because of the body’s inability to synthesize them. The ten essential amino acids are 

arginine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, 

and valine (Kuiken and Lyman, 1949). Soybean provides these ten essential amino acids 

necessary for human nutrition, which is in addition to another 10 which can by synthesized by 

human metabolism from other nitrogen containing precursors (Kuiken and Lyman, 1949). The 

essential amino acid composition of soybean and soy-based products is provided in the USDA 

National Nutrient Database for Standard Reference (USDA-ARS, 2008b).

Isoflavones

Soybeans contain isoflavone compounds, polyphenol compounds closely related to the 

antioxidant flavonoids found in other plants (Manach et al., 2004). Soybean isoflavones are 

described as phytoestrogens because they exhibit estrogenic activity similar to estradiol 

hormones (Rostagno, 2009). These isoflavones may provide both benefits and negative impacts, 

as they are variously reported to exhibit estrogenic and anti-estrogenic effects, influence 

cardiovascular disease, impact cancer rates, and possibly slow the rates of osteoporosis. The 

major soybean isoflavones include genistein and daidzein. Isoflavones are produced primarily by

beans and other legumes such as peanuts and chickpeas. (See Higdon and Drake (Higdon and 

Drake, 2009) for a summary of recent research on soy isoflavones.) The negative impacts of 

isoflavones are those that have been shown to have some adverse consequences to pest insects 

that feed on them, such as feeding inhibition for larvae of the moth Spodoptera litura among 

others (Zhou et al., 2011).

Antinutrients

Antinutrients are components of a food product which may be toxic at high concentrations, bind 

nutrients, or otherwise prevent their digestion. Soybeans contain several key antinutrients, such 

as oligosaccharides, lectins, phytic acid, and protease inhibitors (OECD, 2001). Protease 

inhibitors include trypsin and chymotrypsins (OECD, 2001). Lectins are sugar-binding protein 
13

inhibitors. The activity of these inhibitors is destroyed during the heat processing of soybean 

products. The carbohydrates stachyose and raffinose which are oligosaccharides can cause 

flatulence when consumed (Rackis, 1974). Phytic acid binds most of the phosphorus in soybean, 

preventing its absorption by an animal. It is common practice to add phytic acid-degrading 

enzymes to the animal feed formula (Monsanto, 2010b). Protease inhibitors interfere with the 

digestion of proteins, resulting in decreased animal growth (OECD, 2001). The antinutrients are 

destroyed during the heat treatment processing of the soybean products (OECD, 2001).

Fatty Acids

Saturated fatty acids in soybean include palmitic and stearic; whereas palmitic acid raises total 

cholesterol and low density lipoprotein (associated with adverse cardiovascular events) stearic 

does not (see review in (Micha and Mozaffarian, 2010)). Polyunsaturated fatty acids in soybean 

include linoleic and linolenic, and the monounsaturated fat is oleic. Evidence from the best 

human studies show that when polyunsaturated fatty acids replace saturated ones in the diet, the 

risk of cardiovascular heart disease declines (but not when caloric replacement is carbohydrate) 

(Micha and Mozaffarian, 2010). When monounsaturated fatty acids (e.g., oleic acid) replace 

saturated fatty acids, effects are uncertain because of mixed evidence at present (Micha and 

Mozaffarian, 2010). Trans-fats in the diet are unhealthy; these are produced when soybean fatty 

acids such as linolenic and linoleic are subjected to hydrogenation because of inherent low 

stability, or because properties of soybean oils are unsuitable for certain food uses. 

Incorporation of consequent trans-fats in foods results in known undesirable effects on blood 

lipid parameters (lowering HDLs, increasing triglycerides, and increasing LDLs). In turn, these 

measured parameters of human health correlate with adverse effects on cardiovascular health 

(see review in (Micha and Mozaffarian, 2008)).

2.2 Agricultural Production of Soybean

Soybean (Glycine max (L.) Merr.) plants are grown for their seed, which is further processed to 

yield oil and meal. In the U.S., the majority of soybean is cultivated as a commodity crop for 

animal feed and soybean meal (Monsanto, 2010b). Soybean is ranked number one in oil 

production (58 percent) among the major oil seed crops production in the world (ASA, 2011). 

Recently, there has been an increase in the percentage of the crop dedicated to specialty soybean 

produced for a specific market or use. These specialty, value-added products may be the whole 

bean or a fraction, such as the oil (Lee and Herbek, 2004). The production of specialty soybean 

is discussed in more detail in Subsection 2.2.5.

2.2.1 Acreage and Area of Soybean Production

Soybean production in the U.S. extends over a wide range of geographies and regions, and is 

grown from North Dakota to Louisiana and from the Great Plains states to the Eastern Seaboard 

(USDA-NASS, 1997). In the U.S., soybeans were harvested on 76.4 million acres in 2009 and 

76.6 million in 2010 (USDA-NASS, 2011a). At least 31 states grew soybean as an annual crop 

in 2010 (USDA-NASS, 2011a). For the 2010 growing season, more than one million acres of 

soybeans were grown in each of the following 18 states (from highest to lowest acreage): Iowa, 

Illinois, Minnesota, Indiana, Missouri, Nebraska, Ohio, Kansas, South Dakota, North Dakota, 

Arkansas, Michigan, Mississippi, Wisconsin, North Carolina, Tennessee, Kentucky, and 
14

Louisiana (USDA-NASS, 2011a). Harvested soybean is projected to slightly increase to nearly 

80 million acres by 2020 (USDA-NASS, 2011b; USDA-OCE, 2012).

Although soybean acreage has increased from 2005 to 2010 by about 7% (USDA-NASS, 

2011a), the potential for an increase into uncultivated acreage is low because soybean is 

profitably grown on high quality agricultural land, not lands of lower productivity (EIA, 2007; 

USDA-NASS, 2011a). Much of the high quality land in the U.S. is already committed to 

agricultural production (US-EPA, 2007) and in 2002, USDA- Economic Research Service 

(USDA-ERS) estimated that only 2.1% of cropland was idle in 2002 (Lubowski et al., 2006). At 

the same time, U.S. crop and agricultural acreage is declining through replacement by urban and 

other developed areas (EIA, 2007). It is unlikely that “new” previously uncultivated land will be 

brought into soybean production, but rather that growth of soybean production will compete 

with other agricultural uses (EIA, 2007).

Genetically modified plants, including soybeans, have been widely planted, with increasing 

frequency after their commercial introduction in the late 1990s. GE soybeans currently are 

planted on the majority of soybean acres in the U.S. (93% of acreage in 2010) (USDA-ERS, 

2011a). All these GE soybean varieties are herbicide resistant. Besides genetically modified 

soybean varieties with crop production traits, such as herbicide tolerance, varieties expressing 

altered fatty acids are also available to growers (e.g., low linolenic varieties, see Specialty 

Soybean Production, Soybean Varieties with Altered Fatty Acids in Section 2.2.5 and (Fehr, 

2007)). At present, these fatty acid modified lines are non-transgenic products, but new GE 

varieties are being developed (Cahoon, 2003).

Monsanto plans to channel production of SDA soybean into a limited region using several 

strategies identified below (Monsanto, 2010c). Constraints on production areas will be imposed 

by the seed provider (see first bullet below) and, to some extent, also by the biology of the 

specialty crop (see third bullet). Several measures are currently used in the production of 

specialty soybeans, including contracts specifying details of production and sales between 

growers and soybean purchasers (see second bullet). These measures will be used by Monsanto 

to limit the production area of MON 87769 soybean: 

 The relative maturity groups (MG) in which the developer releases the traits. Growers must 

use varieties which are best adapted to the local season. Day length, temperature and length 

of the growing season may affect the time of flowering and seed formation (Setiyono et al., 

2007) and soybean maturity is affected by the local day length (Cober et al., 1996). Thus, 

soybean yield, and therefore, commercial value, is a consequence of the MG and planting 

location. 

 The area in which designated elevators and specialty oil crushers are located. Soybean 

growers will sign contracts with elevators and processors which will be designated in 

advance by the trait developer. These businesses would have compartmented storage 

available for specialty oilseed crops, and would agree to conditions specified in Monsanto’s 

management plan, which would be required for segregating the crop. If soybean buyers are 

located too distant from production sites, cost of transport increases and profits decline; 

economic penalties further constrain soybean movement.

 The environment in which the soybeans are grown determines desired properties of the 

soybeans. Monsanto has determined that states located in the northern U.S. provide the 
15

optimal environment for maximal expression of SDA from MON 87769 soybean (Monsanto, 

2010b).

Through these means, Monsanto will be able to limit where growers produce MON 87769 

soybean which will be the states of North and South Dakota, Minnesota, Wisconsin, and 

Michigan (Monsanto, 2010c). Some of the largest soybean production areas, such as Illinois, 

Iowa, Indiana and Missouri, would not be included in Monsanto’s targeted production area. The 

area of production will include the northern-most area of the Heartland (McKnight, 2004). This 

area south of the Great Lakes encompasses Minnesota, Wisconsin, Michigan, and parts of South 

Dakota, which is characterized as lowland, level with some hills, and with fertile soils

(McKnight, 2004). Corn, soybean, alfalfa, hay, fruit, beef cattle, hogs and dairy cattle are 

produced here. The other area where Monsanto plans to target production of MON 87769 

soybean is the eastern-most fringes of the Great Plains and prairies, which includes parts of

North and South Dakota. These lands are characterized as flat or sloping land (McKnight, 2004). 

Wheat, but also corn, soybean, sorghum, canola, sunflower, edible beans and peas, barley and 

rye, flaxseed, oats and sugar beets are grown here; cattle may be produced in this region; areas 

that are under irrigation allow vegetable and fruit production for cities (truck crops). These areas 

targeted by Monsanto for MON 87769 soybean production are areas where considerable 

commodity soybean is already produced (Tables 2 and 3).
16

Table 2. U.S. soybean production in Northern Tier states in 2010.

State

Acres Harvested 

(x 1000)

Production

(x 1,000 bushels)

Yield (bushels 

per acre)

Michigan 2,090 91,960 44

Minnesota 7,310 328,950 45

North Dakota 4,050 149,850 37

South Dakota 4,150 166,000 40

Wisconsin 1,630 79,870 49

Total U.S. 76,823 3,408,211 44

Source: Crop Production. Soybean, October 10, 2010. (USDA-NASS, 2010a)

Table 3. Rank of soybean production in Northern Tier states and the U.S. in 2007 along 

with other principal crops.

State First Rank Crop Rank of Soybean 

Crop in State

Rank of State 

Soybean Production 

in U.S.

Michigan Corn (for grain) 2 3

Minnesota Corn (for grain) 2 12

North Dakota Wheat (for grain) 2 9

South Dakota Corn (for grain) 4* 34

Wisconsin Corn (for grain) 3 15

Source: 2007 Census of Agriculture (USDA-NASS, 2009)

Note: *Wheat, forage and soybean acreage nearly equal

2.2.2 Agronomic Practices

In this EA, “conventional farming” includes any farming system where synthetic pesticides or 

fertilizers may be used. Conventional farming covers a broad scope of farming practices, 

ranging from farmers who only occasionally use synthetic pesticides and fertilizers to those 

farmers whose harvest depends on regular pesticide and fertilizer inputs. Conventional farming 

also includes the use of genetically engineered (GE) varieties that are no longer subject to the 

regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection 

Act.

Soybean self-pollinates and is propagated by seed (OECD, 2000). Proper seedbed preparation, 

appropriate variety selection, appropriate planting dates and plant population, and good 
17

integrated pest management practices are important for optimizing the yield potential and 

economic returns of soybean (Barrentine, 1989; USDA-APHIS, 2010b).

Soybean Maturity Groups

Soybean varieties are developed and adapted to certain geographical zones (bands about 100-150 

miles north to south) and are separated into ten maturity groups – Group 00 to Group VIII: 

Group 00 through Group IV soybean varieties are planted in the Midwest and Eastern Coastal 

regions; Groups IV through VIII are planted in the southern states (Helsel and Minor, 1993; 

Hodges and French, 1985; Pioneer, 2011). To adapt to the local growing season, producers 

typically plant seed of an appropriate maturity group so that its development and harvest 

coordinates with the seasonality of the location. To avoid frosts and maximize yield and oil 

content, the grower’s priority is to plant soybean as early as possible and to use the early

maturing varieties (North Dakota) (Berglund and Helms, 2003). In the five Northern Tier states,

the 0-2 maturity groups would be generally planted (Zhang et al., 2007), but University of 

Wisconsin Extension (UW-Extension, 2008 ) has tested maturity groups between 0.1 and 2.8 in 

various parts of Wisconsin to match local conditions. In parts of Michigan, a maturity group as 

high as 3.4 might be planted (MSU-Extension, 2010) and in parts of North Dakota 00 or even 

000 might be planted (Kandel, 2008).

Pre-Season Preparation

Crop rotation, tillage system, row spacing, planting equipment, seed or trait selection(s), 

herbicide choices and details of soil fertility require production decisions well in advance of 

planting the soybean crop.

Planting and Early Season

Adequate soil moisture and warm temperatures facilitate rapid seed germination and emergence. 

Planting date has the greatest impact on yield (Hoeft et al., 2000). Soybean can germinate at a 

soil temperature of 50 degrees Fahrenheit (oF) when planted at a depth of two inches, with the 

ideal soil temperature for soybean germination and emergence at 77oF (Pedersen, 2010; Pedersen 

and Lauer, 2004). However, waiting for soils to reach this soil temperature will delay planting 

beyond the optimum planting date that will maximize yield. 

Highest soybean planting activity begins in mid-May (as early as the 10th in some states) and 

continues through early June, with Wisconsin planting as late as June 20 (USDA-NASS, 1997). 

As an example, in Wisconsin, although the highest yield comes from planting before May 20, 

delayed planting to June 1 could reduce yield to an estimated 89 per cent and by June 10 to 75 

percent (with a plant population of 200,000) (Conley and Gaska, 2011).

Recommended herbicide use in Roundup Ready Soybean (NDSU Weed Science): 

 Strategy 1: Pre-emergent herbicide or pre-plant incorporated metolochlor, pendimethalin, 

Fierce, or metribuzin, etc. used. Most require rain for activation.

 Strategy 2: Glyphosate applied to early emerged weeds.

 Strategy 3: Glyphosate applied to 2-4 inch weeds.
18

For tillage practices in early season, see Tillage section, below.

Mid- to Late Season

Ideal daytime temperatures for soybean growth are between 75oF and 85oF (Hoeft et al., 2000). 

Warmer temperatures result in larger plants and earlier flowering. Sustained temperatures below 

75oF will delay the beginning of flowering significantly. Seed set also is affected by

temperature. Seed set is generally ideal when pollination follows night temperatures around 

70oF. Soybean varieties differ in their response and tolerance to temperatures.

The first appearance of flowers signals the beginning of the reproductive stage (Hoeft et al., 

2000). The reproductive period consists of flowering, pod set, and seed formation. Climatic 

conditions such as temperature and moisture supply during the flowering period will affect the 

number of flowers. The soybean plant does not form a pod for each flower. It is common for a 

soybean plant to have 75% of its flowers fail to develop a pod (Monsanto, 2010b; Scott and 

Aldrich, 1970).

Recommended herbicide use in Roundup Ready Soybean (NDSU Weed Science):

 Strategy 1: Glyphosate applied to soybean post-emergent (follows early pre-emergent soilapplied or -incorporated herbicide).

 Strategy 2: Post emergent herbicide acetochlor, imazamox, bentazon/sethoxydim, 

acifluorifen (follows glyphosate applied pre- emergent to soybean).

 Strategy 3: Roundup/glyphosate 14-21 days after first application (follows glyphosate 

applied to pre-emergent soybean).

For tillage practices in mid and late season, see Tillage section, below.

Harvest Season

At maturity, the seed moisture content is approximately 55 to 60%. At this stage, at least one 

pod on the plant reaches maturity (Hoeft et al., 2000). Under warm and dry weather conditions, 

seed moisture content will drop to 13 to 14% in 10 to 14 days from physiological maturity (Hoeft 

et al., 2000). Soybean is harvested when the moisture content drops below 15%. From 

preharvest through combining, soybean loss can vary between 3 and 10% and greater, depending 

upon operating processes and equipment adjustment (Bennett et al., 2011).

Harvesting activity is highest in the five states of South Dakota, North Dakota, Minnesota, 

Michigan, Wisconsin between late September (North Dakota) and mid- to late-October 

(Wisconsin: early November) (USDA-NASS, 1997).

Recommended fall herbicide use in Roundup Resistant Soybean for next season soybean (MSU, 

2011):

 1: Burndown without residual activity: glyphosate, gramoxone, 2,4-D.

2: Burndown with residual activity: Authority Assist, Canopy, Autumn, Extreme.

Crop Rotation
19

Soybean crop rotation is an important management practice for managing weeds, to control 

volunteer soybeans, and to limit the potential for weeds to develop resistance to herbicides (e.g., 

glyphosate-resistant pigweed). According to USDA-ERS, 95% of the soybean-planted acreage 

has been in some form of a crop rotation system since 1991 (USDA-ERS, 2010c).

The benefits of soybean rotation with, for example, corn are many and include:

• Improved yield and profitability of one or both crops;

• Decreased need for additional nitrogen on the crop following soybean;

• Increased residue cover; 

• Mitigation or disruption of disease, insect, and weed cycles;

• Reduced soil erosion; 

• Increased soil organic matter;

• Improved soil tilth and soil physical properties; and

• Reduced runoff of nutrients, herbicides, and insecticides (Al-Kaisi et al., 2003).

Agronomic practices for soybean rotations vary from state to state. Continuous (i.e., nonrotation) soybean production is discouraged by most extension soybean specialists to reduce the 

risk of diseases and nematodes (Al-Kaisi et al., 2003). In a survey of major corn/soybean 

production states, corn and soybean were alternated on 72 to 80% of acreage, other rotations 

were grown on 16 to 20 % of acreage, and soybean was grown continuously on 5 to 12% of 

acreage during the years 1996-2002 (Sandretto and Payne, 2008). In another analysis, the 

majority of the U.S. soybean acreage (68.6%) is rotated to corn ((Monsanto, 2010b) at page 157, 

et seq.). Approximately 14.5% of the soybean acreage is rotated back to soybean the following 

year. Wheat follows soybean on approximately 11.2% of the U.S. soybean acreage, with cotton, 

rice, and sorghum the next largest rotational crops following soybean (4.6% of the soybean 

acreage). Other minor rotational crops that follow soybean production include barley, rice, oats, 

and dry beans.

In the Northern Tier states where MON 87769 soybean would likely be grown, corn is often 

grown following soybean, but other crops may be added to the basic rotation, often small grains 

(Table 4) (UW-Extension, 2004). In eastern South Dakota, a corn-soybean rotation when 

coupled with a wheat crop is advantageous, since it may reduce yield losses caused by cornsoybean adapted Diabrotica species (corn rootworm), soybean cyst nematode, and weeds that 

proliferate in soybean and corn (Anderson, 2008). In southwestern Michigan, increasing crop 

diversity in crop rotations has been shown to increase corn grain yield (Smith et al., 2008). 

Double cropping (i.e., plantings two crops in the same field within one year) of soybean with 

wheat is discouraged, since a predictable rate of return on late planted soybean cannot be 

established (Conley et al., 2008).
20

Table 4. First and second most frequent rotational crop following soybean 

State Rotational Crop 

Following Soybean

Percentage of 

rotational crop planted

Michigan Corn 70

Wheat 25

Minnesota Corn 76

Wheat 18

North Dakota Corn 30

Wheat 45

South Dakota Corn 72

Wheat 20

Wisconsin Corn 85

Alfalfa 4

Source: Table IX-8, column G, based on personal communications with state extension specialists and Monsanto 

Technology Development Representatives (Monsanto, 2010b).

Tillage

Mechanical weed control by means of tillage is an important aspect of soybean cultivation, and 

in 2006, no-till production ranged from 9.2 to 47.7% of soybean production in the five Northern 

Tier states in 2006 (Horowitz et al., 2010). Other types of conservation tillage, reduced and 

conventional tillage, made up the remainder. Conservation tillage practices have seen increased 

use throughout the U.S. in recent years, especially in the Midwest where wind and water erosion 

are often important farm issues. The percentage of planted land in the U.S. managed in 

conservation tillage increased from 26% in 1990 to 41% in 2004 (Sandretto and Payne, 2008). 

Soybean tillage has been summarized in five categories, with two groups, one of “conservation 

tillage” (no-till, ridge-till and mulch-till) or “other tillage practices” (reduced till and intensive 

till) (CTIC, 2010b). Conventional tillage is associated with intensive plowing and less than 15 

percent crop residue; reduced tillage is associated with 15 to 30 percent crop residue; and 

conservation tillage, including no-till practices requiring herbicide application on the plant 

residue from the previous season, is associated with at least 30 percent crop residue and 

substantially less soil erosion than other tillage practices (US-EPA, 2009). Almost 40% of full 

season soybean acreage is under no-till practice, while another 23% is under a specialized type of 

conservation tillage. Another 20% of soybean acres are intensively tilled. 

In addition to preplant tillage preparations, cultivation for weeds might also be undertaken

because a preplant residual herbicide was not activated by precipitation, and immediate control is 
21

required (IPMCenters, 2011). Pre-emergence herbicides may also need activation, and failing 

adequate rainfall, rotary hoes or harrows may be deployed at soybean emergence (IPMCenters, 

2011). Weed escapes from herbicide treatment may also be remedied with shallow cultivation 

(IPMCenters, 2011).

Nitrogen Fertilization

Soybeans remove up to 70 pounds of nitrogen from the soil when a 50-bushel yield of soybean is 

attained, with only about 35% of that originating from soil (Hoeft et al., 2000). The remaining 

nitrogen needs of soybean come from symbiotic nodulating bacteria of the families Rhizobiaceae 

and Bradyrhizobiaceae, and these form a symbiotic relationship with soybean (Gage, 2004). The 

symbiosis between nitrogen-fixing plant-microbe and the plant results in the formation of root 

nodules, providing an environment in which differentiated bacteria reduce or fix atmospheric 

nitrogen. The product of nitrogen fixation, ammonia, then can be used by the plant (Gage, 

2004). USDA-ERS (USDA-ERS, 2010e) estimates that less than 40% of soybean acres in the 

U.S. receive nitrogen fertilizer. Given the important role of these bacteria for meeting nitrogen 

needs of soybean, commercial sources of inoculants such as multiple strains of Bradyrhizobium

can be applied to soybean seeds just before planting (Beuerlein, 2005). These bacteria must be 

supplied if a soybean crop has not been recently grown on the field (Bottomley, 1992), and if 

nodulation is inadequate, supplemental nitrogen may be required for the developing crop 

(Ferguson et al., 2006). Maintaining an optimal pH is important to proper initiation of 

nodulation, and in a typical corn-soybean rotation, pH of about 6 is a good target (Hoeft et al., 

2000).

Weed Control

One of the highest priorities in soybean production is weed management (Hoeft et al., 2000). 

Weeds compete with soybean for water, soil nutrients and light, and may ultimately reduce yield. 

Growers use cultural methods, cultivation and herbicides to control crop competitors, and,

depending on the strategies chosen, different herbaceous annuals, perennials, or even woody 

species can become established (Hoeft et al., 2000). Weeds present during an entire growing 

season can result in soybean yield losses ranging from 12 to 80% (Barrentine, 1989).

U.S. soybean farmers began augmenting tillage with herbicides to control weeds in the late 

1950s, but tillage in crop production remained an important strategy (Gunsolus, 1990). By the 

early 1990s, there were over 70 individual herbicides or combination products registered for 

weed control in soybean (Gianessi et al., 2002). As additional herbicides became available, the 

possibility of the conservation-enhancing use of reduced tillage or no-till became feasible 

(Givens et al., 2009). Next, as herbicide-tolerant GE crops were no longer subject to the 

regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection 

Act beginning in 1996, a larger number of growers were able to adopt conservation tillage 

strategies (Givens et al., 2009). 

The use of herbicides is directly related to choices made by soybean producers for tillage 

options. Herbicides can directly substitute for tillage, and their use often offers better 

management than tillage alone (Gianessi and Reigner, 2007). Consequently, as noted, there has 

been a trend towards less tillage as a greater number of herbicide choices and options have 
22

become available. As herbicide-resistant crops were offered and deployed, increased amounts of 

conservation tillage began to be practiced, since particularly wide spectrum herbicides (such as 

glyphosate) could be used on soybean. Although herbicide-tolerant varieties have become the 

most widely planted soybean in the U.S. (94% of all soybean acreage in 2011 (USDA-ERS, 

2011a)), especially Roundup Ready

®

varieties, the developer of the technology still recommends 

that growers add tillage or other herbicides, as appropriate, in their Roundup Ready®soybean 

production methods (Monsanto, 2011).

Foxtail spp., pigweed, velvetleaf (Abutilon theophrasti), lambs quarters (Chenopodium album), 

and cocklebur (Xanthium strumarium) are common annual weeds in Midwest corn and soybean 

fields. However, growers consider giant ragweed (Ambrosia artemisiifolia), lambs quarters, 

Canada thistle (Cirsium arvense), cocklebur, and velvetleaf to be the top five most problematic 

weeds in corn and soybean because of the difficulty of controlling these weeds (Nice and 

Johnson, 2005). For Minnesota soybean, yellow foxtail, common ragweed and common 

lambsquarters are prominent, with winter annuals such as mustards, horseweed, and biennials 

such as wormwood important weeds; perennial broadleaf weeds include Canada thistle, common 

milkweed and hemp dogbane which can be difficult to manage in soybean (Potter and Ostlie, 

2003). Eighty-six common weeds of soybean across three growing regions (Midwest, MidSouth, and Eastern Coastal) were identified in another soybean petition for nonregulated status 

(pages 150-151 in (Monsanto, 2010a)). 

Commercial soybean production may require at least one herbicide application for effective 

weed control. Most commonly, weeds are controlled by planting glyphosate-tolerant soybean 

varieties, and applying glyphosate at least once during production. In some places glyphosate 

resistant weeds have been reported, such as pigweed and morning glory (Heatherly et al., 2009; 

Woodruff et al., 2010). These resistant weeds can be managed by applying herbicide 

combinations with different modes of action, as well as crop rotation, varying row spacing, and 

mechanical removal of weeds (Woodruff et al., 2010). In 2002, it was calculated that 96 percent 

of all planted soybeans were treated with at least one type of herbicide, ranging from 0.04 to 0.71 

pounds (lbs) of product per acre. In 2006, herbicides were used on 98 percent of soybean acres

of surveyed states (USDA-NASS, 2007b). Table 5 shows principle herbicides used on soybean 

in two Northern Tier states. Weed species are also discussed in Section 2.4.2, Plant 

Communities.
23

Table 5. Principal herbicides used in soybean production and percentage of acres 

applied—selected states.

State

Herbicide

Glyphosate 2,4-D Imazathapyr Pendimethalin Clethodim Trifluralin

Percent of total acres applied

Wisconsin* 

(2006) 85 11 9 9 -- --

Minnesota** 

(2007) 91 -- -- -- 2 2

Sources:

* NASS, Wisconsin Field Office (USDA-NASS_Wisconsin-Field-Office, 2009 download).

** Minnesota Department of Agriculture (MDA, 2009).

Various other pesticides may also be used for soybean production, including insecticides, 

fungicides, and nematicides. In 2006, insecticides were used on 16 percent of soybean acres. 

The three most common insecticides, lambda-cyhalothrin, chlorpyrifos, and esfenvalerate, were 

applied to 6, 5, and 3 percent of the planted acres, respectively (USDA-NASS, 2007b). In

addition to these three insecticides, a total of 10 other insecticides are recommended for use on 

soybeans for aphid control (UM, 2011).

2.2.3 Soybean Seed Production

Soybean seed is separated into four seed classes: 1) Breeder; 2) Foundation; 3) Registered; and 

4) Certified (see, e.g., (MCIA, 2009, 2010)). Each class of seed is identified to designate the 

seed generation from the original breeder source (Hartman and Kester, 1975). The original seed 

breeder seed stock is controlled by the developer of the variety (Adam, 2005; Hartman and

Kester, 1975). The Breeder stock is used to produce Foundation seed stock (Adam, 2005). 

Foundation seed stock, in turn, is used to produce Registered seed for distribution to licensees, 

such as seed companies (Adam, 2005). Registered seed is used by seed companies to produce 

large quantities of Certified seed (Adam, 2005; Hartman and Kester, 1975). The Certified (or 

Select) seed is then sold to growers through commercial channels (Adam, 2005; Hartman and 

Kester, 1975). 

Seed quality (including genetic purity, vigor, and presence of weed seed, seed-borne diseases, 

and inert materials such as dirt) is a major requirement for successful seed crop production. If 

natural variability and environmental effects upon seed production are not carefully controlled, 

the value of a new variety or cultivar may be lost (Hartman and Kester, 1975). Genetic purity in 

commercial seed production is generally regulated through a system of seed certification which 

is intended to ensure that the desired traits in the seed are maintained throughout all stages in 

cultivation (Hartman and Kester, 1975). 

States have developed seed laws and certification agencies to ensure that purchasers who 

received certified seed can be assured that the seed meets established seed quality standards 

(Bradford, 2006). The U.S. Federal Seed Act of 1939 recognizes seed certification and official 
24

certifying agencies. Implementing regulations further recognize land history, field isolation, and 

varietal purity standards for Foundation, Registered, and Certified seed. 

Foundation seed, Registered seed, and Certified seed production is controlled by public or 

private seed certification programs (AOSCA, 2009). Commercially certified soybean seed must 

meet state and Federal seed standards and labeling requirements. Federal Seed Act regulations 

are detailed in 7 CFR 201. State seed certification standards may vary slightly from state to state 

and can be more restrictive than the seed standards of AOSCA (Association of Official Seed 

Certifying Agencies) (GCIA, 1988; NCCIA, 2011; Seed Certification Department, 2001). The 

values for certified soybean seed standards from AOSCA are as follows (AOSCA, 2009): 

 98% pure seed (minimum);

 2% inert matter (maximum); 

 0.05% weed seed (maximum; not to exceed 10 per pound (lb)); 

 0.60% total of other crop seeds (maximum); 

 0.5% other varieties (maximum; includes off-colored beans and off-type seeds); 

 0.10% other crop seeds (maximum; not to exceed three per lb); and 

 80% germination and hard seed (minimum). 

In addition to these specific factors, soybean certification standards identify land requirements 

and field practices that must be followed. Soybeans must be grown on land on which the 

previous crop grown was of a different type, certified seed of the same variety, or a variety 

having noticeable characteristic differences. In addition, for every 200 certified soybean plants, 

only one off-type or other variety is allowed (AOSCA, 2009). Certified seed crop is subject to 

field inspections by certifying agencies at harvest and other times in order to observe factors 

related to seed certification and determine genetic purity and identity. Harvested seeds may be 

inspected and sampled at any time (AOSCA, 2009).

All soybean seed sold may not be officially certified; however, commercial soybean seed sold 

and planted for normal soybean production is produced predominately to meet or exceed 

certified seed standards.

Seed certification systems should be distinguished from identity preservation systems for certain 

agricultural commodities. Soybean Identity Preservation (IP) refers to a system of production, 

handling, and marketing practices that maintains the integrity and purity of specialty crop 

products (Sundstrom et al., 2002). MON 87769 soybean is expected to be handled and marketed 

within the practices of the certified seed system, and is expected to meet all state and federal seed 

standards and labeling requirements.

2.2.4 Organic Soybean Production

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

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

farming can be marketed and labeled as “organic” (USDA-AMS, 2010). 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.
25

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

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

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

procedures comply with USDA organic standards. 

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

guidance under 7 CFR Section 205.105:

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

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

the use of:...

(a) Synthetic substances and ingredients,...

(e) Excluded methods,...

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

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

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

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

methods include cell fusion, microencapsulation and macroencapsulation, and 

recombinant DNA [deoxyribonucleic acid] 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, 2010).

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

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

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

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

between the fields (Baier, 2008; Bradford, 2006; NCAT, 2003; Sundstrom et al., 2002).

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, 2010). 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 
26

as detailed in their approved organic system plan (Ronald and Fouche, 2006; USDA-AMS, 

2010).

The production of organic soybeans represents between 0.17% and 0.22% of total U.S. soybean 

production (USDA-ERS, 2010d). In 2005 and 2008, 122,217 and 125, 621 acres of soybean in 

the U.S., respectively, were certified organic (USDA-ERS, 2010d). In the Northern Tier states 

for 2008, approximately 50,500 acres were certified organic (Table 6), which represents less than 

0.3% of the total soybean crop in the region (USDA-ERS, 2010d). Organic soybean markets 

typically enjoy a market premium offsetting the additional production and record-keeping costs 

associated with this production method.

Table 6. Certified organic soybean acreage, 2007 and 2008.

State 2007 

Acreage

2008 

Acreage

Percent of total 

U.S. organic 

soybean acreage 

(2008)

Michigan 11,320 11,251 9.0

Minnesota 25,518 21,229 17

North Dakota 3,308 3,773 3.0

South Dakota 4,531 4,786 3.8

Wisconsin 8,381 9,369 7.5

Total Northern Tier states 53,058 50,408 41

Total U.S. 100,390 125,621

 Source: (USDA-ERS, 2010d).

2.2.5 Specialty Soybean Production

Identity Preservation (IP) refers to a system of production, handling, and marketing practices that 

maintains the integrity and purity of specialty crop products (Sundstrom et al., 2002). 

Commodity grains are marketed en masse according to USDA grading standards. Specialty 

crops require some form of segregation or IP to keep these grains separate from commodity

grains (Elbehri, 2007). This segmentation helps preserve a specified purity of the product. With 

certain specialty crops (e.g., organic or designated industrial-uses), IP is required to prevent 

accidental or unintended commingling. Should the IP crop be admixed with a different variety, 

contracts between growers and purchasers define acceptable limits of such admixture. If defined 

purity is not attained, the buyer can reject the crop, and the grower would not receive the 

premium price specified by the contract. Thus, financial penalty encourages the grower to 

maintain standards expected by the buyer and by those users further along in the supply chain.

Comments submitted in previous environmental assessments have identified issues pertaining to 

management practices designed to prevent accidental or unintended commingling of crops. 

Many of these practices are already well established in the soybean industry as part of the crop 
27

cultivation practices necessary to maintain IP. The need for segregation and IP production 

systems has increased with the development of specialty crops or crops with special output traits, 

such as high oil corn, high oleic sunflower, and low-linolenic soybean (Sundstrom et al., 2002). 

MON 87769 soybean is expected to be handled and marketed within the practices of a Closed 

Loop IP (see definition in Section 4.2.5) production system (Monsanto, 2010b).

Specialty Soybean Types

The U.S. soybean IP production and distribution systems accommodate differences between 

commodity and specialty soybean. Production systems designed prior to the introduction of 

MON 87769 soybean or even prior to the introduction of biotechnology-derived soybean 

allow for production of specialty soybean varieties to meet varied customer demands. 

Although soybeans are primarily a commodity crop, there is an existing specialty soybean 

market. Distinct identity-preserved specialty soybean with such traits as clear hilum or high 

protein have been grown and successfully marketed for specific food uses in domestic and 

export markets for many years (Cui et al., 2004). 

Specialty soybeans can be grouped into several broad categories (Monsanto, 2010b; UK, 

2010) including: 

 non-biotechnology-derived,

 certified seed,

 organic food-grade,

 low saturated fat,

 clear hilum,

 tofu,

 natto,

 high sucrose,

 high oleic,

 low linolenic, and

 high protein.

The categories refer to soybean with characteristics such as altered seed composition (e.g., 

low saturated fat, high sucrose, high oleic, low linolenic, and high protein), varieties of 

soybean with unique physical characteristics suited to their specific uses (e.g., clear hilum 

for direct human consumption), or refer to a production process (e.g., organic, certified 

seed). The categories are not meant to be exclusive; for example, soybean used to produce 

natto or tofu may employ organic production processes. Moreover, soybeans of all specialty 

categories are often derived from varieties produced according to certified seed production 

practices. Tofu and soymilk produced from the tofu soybean category represent a large 

segment of the specialty soybean market and are produced from unique soybean varieties 

that have clear hilum and large seed size (Lee and Herbek, 2004). Tofu varieties also must 

be high in protein (40% or higher) and low in oil concentration compared with commodity 

soybean. Clear hilum (i.e., the small scar marking the seeds former place of attachment to 

the pod) and other characteristic are required for soybean used in the production of other 
28

soybean food products consumed directly by humans such as natto, soybean sprouts, 

edamame (vegetable soybean), and soy nuts (Lee and Herbek, 2004; UK, 2010). 

The majority of these specialty soybean varieties are offered in Maturity Group II and early 

Group III varieties which are adapted to the upper Midwest/Great Plains region (Lee and 

Herbek, 2004). Vistive®soybean with low linolenic traits are offered by Asgrow in 

Maturity Groups 2.0 to 3.6 (Asgrow, 2011).

Specialty Soybean Production

Specialty soybean varieties are specified by buyers and end-users of soybean for production, 

and premiums are paid for delivering a product that meets purity and quality standards for 

the soybean variety. Product differentiation and market segmentation in the specialty 

soybean industry includes mechanisms to keep track of the soybean (traceability), methods 

for IP, such as quality assurance processes (e.g., ISO 9001-2000 certification), as well as 

contracts between growers and buyers that specify delivery agreements.

The distinction between the commodity soybean and the specialty soybean involves both 

certified seed production as well as IP of the harvested crop. The majority of soybean in the 

U.S. is cultivated and marketed as a commodity for the oil and protein markets (Monsanto, 

2010b). The goal of the commodity supply chain is to supply a homogenous product to the 

end user. Although the grower producing soybean for this chain may choose from many 

different varieties for cultivation, the harvested soybean is viewed to be the same for all 

commodity soybean varieties (Monsanto, 2010b). 

At harvest, the grower either delivers soybean to a handler or stores them on farm for later 

delivery. The commodity soybean is not differentiated for later use. Commodity soybean 

handlers typically have large volume storage capacity, and commodity soybean processors 

crush large volumes of soybean to produce homogeneous oil and meal products. The 

commodity system is designed to maximize efficiency at a low profit margin and results in 

comingling of different sources of soybean. The beneficial consequence of mixing soybean 

in the initial crush, increased homogeneity, is also one that does not affect the price received 

for the final product. This production system has been in place in the U.S. since the 

production of soybean began in earnest in the 1960s (Sonka et al., 2004).

The specialty soybean market produces soybeans that have specific physical or chemical 

characteristics to meet specific buyer requirements. As a result of these special needs, a separate 

specialty soybean channel has developed for the specialty soybean product that involves much 

smaller volumes than commodity soybean (Smyth and Phillips, 2002a; Sonka et al., 2004). 

Specialty soybean varieties are produced on approximately 12% of the U.S. soybean acreage 

and, according to the Midwest Shippers Association (MSA, 2009), this acreage could grow to 

over 25% of the crop acreage in certain states within the next decade. In Iowa, 13.5% of 

soybean acres were planted to specialty soybean, and about half of these acres were either nonGE crops or for seed production (Goldsmith et al., 2008). Fehr reported that in 2006, about 

700,000 acres in the U.S. were planted to low and ultralow linolenic acid varieties (Fehr, 2007). 
29

The specialty soybean supply chain typically start with a firm that contracts production of a 

specific variety and sets standards for quality of the harvested soybean (Lee and Herbek, 2004). 

In return, growers receive a premium over the price paid for commodity soybean. Growers may

store harvested soybean on farm or deliver the product directly to an approved processor or to 

special containers for international shipment.

The IP practices used in specialty soybean production require that all equipment and storage 

facilities for specialty soybean must be clean of seed from other soybean varieties or plants, 

dirt, pathogens, and other foreign material (Hanna and Jarboe, 2005). Some soybean 

contracts may require a special inspection of the handling and storage facilities. The 

specialty soybean for soybean foods may require special harvesting equipment because 

some of these soybeans are harvested before full maturity (e.g., edamame or vegetable 

soybean) (Ernst and McNulty, 2011 download).

For specialty soybean, weed control is extremely important in order to maintain a high yield 

potential. Weeds, such as nightshade (Solanum nigrum), can stain harvested soybean, which 

is particularly undesirable in food-grade soybean (TCM, 2008).

Soybean Varieties and Altered Fatty Acids

The genetic changes in soybeans that resulted in altered soybean oil composition have been 

achieved by both conventional and genetic engineering techniques. Varieties were improved 

conventionally by genetic selection and mutagenesis techniques. Among the cultivars currently 

grown for commercial production are those for reduced palmitic and linolenic acids (Fehr, 2007; 

Goldsmith et al., 2008). Non-GE soybean breeders also have obtained varieties with greater than 

70% oleic acid by selection and intercrossing (Alt et al., 2005). 

Nontransgenic lines include those which express low linolenic acid, an oil trait which does not 

require trans-hydrogenation to improve oil properties and increase product stability. Asoyia 

formerly offered an ultralow linolenic variety at 1% of fatty acids (Qualisoy, 2011; Wilkes, 

2008) and Iowa State has made some lines available to growers 

(http://www.notrans.iastate.edu/). Low saturated fat soybeans are also available from Iowa 

Natural (1% linolenic, 7% saturated fats of total oil) (American Heart Association, 2011; NYCDOH, 2009). Low linolenic soybeans with GE herbicide tolerance are marketed by Monsanto 

(‘Vistive’) and Pioneer (‘Plenish’) seed companies, with linolenic acid expressed at less than 3%. 

The Vistive line was planted on 1.5 million acres in 2008 (Monsanto, 2008).

Genetic engineering techniques have been used to increase oleic acid composition in soybean to 

near 80%, but the first altered fatty acid variety no longer subject to the regulatory requirements 

of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act (APHIS Petition # 97-

008-01p (USDA-APHIS, 1997)) has not been planted on a large commercial scale since 2005 

because the developer changed its market strategy. This line is no longer commercially available. 

Another GE high oleic acid variety, DP-304423-1 with a high oleic phenotype conferred by

introduction of the soybean omega-6 desaturase gene 1 (fad2-1 gene) was no longer subject to 

the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection 

Act, but will not be released commercially until 2012 (Plenish (Pioneer Hi-Bred, 2011)). Other 
30

soybean with altered fatty acids have also been petitioned for non-regulated status (MON 87705 

high oleic soybean).

Non-herbicide Tolerant Soybean

In the US, non-herbicide tolerant soybean varieties (conventional, nontransgenic) in the U.S. 

were planted on approximately 8% of the total soybean acres in 2008 (Fernandez-Cornejo et al., 

2002), and many of these are specialty soybeans (Lee and Herbek, 2004). Specialty soybean 

varieties include tofu, natto, bean sprouts, edamame, soynuts, as well as those with unique 

chemical identities, such as those with modified fatty acid profiles, high protein or high sucrose 

content. Farm production of these soybeans is essentially the same as for conventional 

soybeans, although for specific varieties, there may be less tolerance for accidental admixture 

with weed seeds such as nightshade and pokeweed seeds which can stain the soybean seed (Lee 

and Herbek, 2004).

2.3 Physical Environment

2.3.1 Water Resources

The typical amount of water required for a high-yielding soybean crop is approximately 20 

inches during the growing season (Hoeft et al., 2000). Annual state-wide precipitation data 

collected for the 5-state region where MON 87769 soybean may be grown (i.e., North and South 

Dakota, Minnesota, Wisconsin, and Michigan) ranges from approximately 18 to 33 inches 

(NOAA, 2011 download). While normal climatic conditions may provide sufficient water to 

produce a soybean crop, precipitation may vary across a state and from year to year and 

irrigation may be needed to supplement precipitation amounts. Irrigation of soybean acres, 

according to data from the USDA 2007 Census of Agriculture, is used on 4.6 to 15% of soybean 

acres in the five-state region where MON 87769 soybean may be cultivated (USDA-NASS, 

2007c, 2010 ). In some limited areas, such as central Minnesota, soybean is usually produced 

under irrigated conditions (deJensen et al, 2004), and this may be a consequence of the soil

characteristics in specific areas. Soybean acres that are irrigated are a small portion of total 

soybean acres, much less than those acres irrigated for corn (Table 7) (USDA-NASS, 2007c).

Table 7. Irrigation of soybean acres in Northern Tier states.

State

Harvested acresa Irrigated harvested 

acresb,c

Percent 

of

soybean 

acres 

irrigatedc

All crops Soybeans All crops Soybeans

Michigan 6,859,081 1,715,427 1,434,358 66,556 4.6

Minnesota 19,267,018 6,273,919 1,416,247 92,347 6.5

North 

Dakota

22,035,717 3,073,981 233,171 12,513 5.4

South 

Dakota

15,278,709 3,222,872 358,807 52,661 15
31

Wisconsin 8,884,628 1,363,124 373,680 24,855 6.6

United States 309,607,601 63,915,821 86,529,391 2,175,069 2.5

a. Table 1, State Summary Highlights: 2007 (USDA-NASS, 2009)

b. Source: Soybean Irrigated Harvested Acres: Table 33, 2007 Census of Agriculture – State Data (USDA-NASS, 2007c)

c. Total acres from (USDA-NASS, 2007c).

In most states, irrigation water comes predominantly from groundwater sources, with 

comparatively little derived from surface water sources (Table 8). 

Table 8. Water sources used for irrigation of soybean acres in Northern Tier states.

State

Irrigated 

harvested 

soybean acresa

Water Sourcea

Acres irrigated 

with groundwater 

from wells

(% of total)

Acres irrigated 

with on-farm

surface water

(% of total)

Acres irrigated 

with water from

off-farm suppliers 

(% of total)

Michigan 73,986 46,851 (63) 26,155 (35) 1,220 (2)

Minnesota 100,513 100,076 (99) 3,489 (3) -- (NA)

North Dakota 18,939 15,019 (79) 1,802 (10) 2,738 (14)

South Dakota 79,296 57,533 (72) 5,420 (7) 16,733

Wisconsin ND (NA) ND (NA) ND (NA) ND (NA)

United States 7,044,546 6,448,846 619,824 136,708

Source: 

a. Farm and Ranch Irrigation Survey 2008, Table 29 (USDA-NASS, 2010b).

Notes:

Some farms may obtain water from multiple sources.

-- – No irrigation

NA – Not applicable

ND – No data available.

Agricultural non-point source (NPS) pollution is the primary source of discharge pollutants to 

rivers and lakes and a major contributor to groundwater contamination. The EPA lists the most 

important cause of impairment in assessed streams and rivers as pathogens, with sediment 

second, and nitrogen third; pesticides are only the 16th most important (EPA, 2012). Agricultural

management practices that contribute to NPS pollution include the type of crop cultivated, 

plowing and tillage, and the application of pesticides, herbicides, and fertilizers. Agricultural 

pollutants released by soil erosion include sediments, fertilizers, and pesticides that are 

introduced to area lakes and streams when they are carried off of fields by rain or irrigation 

waters (US-EPA, 2005). Excess sediment can directly affect fish and other wildlife mortality

and reduce the amount of light penetration into a body of water. Indirectly, soil erosionmediated sedimentation can increase fertilizer runoff, and facilitate algal blooms and oxygen 

depletion in a body of water (US-EPA, 2005).

Agriculture may contribute to several types of chemicals found in water resources. These 

include nitrogen and phosphorus from applied fertilizers, which, when present at high 
32

concentrations, may lead to eutrophication of surface water, resulting in changes in dissolved 

oxygen concentrations and frequent algal blooms (Carpenter et al., 1998). Other chemicals 

found in surface water runoff may include various pesticides (both herbicides and insecticides) 

which, at high concentrations, may impact humans, plants and animals that are exposed to the 

affected water (Domagalski et al., 2008; Vogel et al., 2008). Some pesticides used on soybeans 

were detected by Vogel et al. (2008) in rainwater, such as chlorpyrifos (64% of samples in a four 

state pattern). In addition to direct impacts to surface water, agricultural chemicals may

eventually impact groundwater when transported by infiltrating surface or irrigation water. 

Irrigation with locally pumped water tends to reduce transport of chemicals in ground water 

because it avoids connecting streams with groundwater (Domagalski et al., 2008). 

Ground water and aquifers may be impacted by agricultural chemicals via infiltration as well. In 

areas where soybean and corn are grown in rotation, such as Nebraska, and where ground water 

is a principle source of water for human consumption, this can be a critical issue (Stanton et al., 

2007). In other areas, surface water movement of contaminants is at issue, and agricultural tile 

drainage systems have been shown to be a source of nitrate entering streams and rivers (Randall 

and Mulla, 2001). In areas where water retention in fields is high, periodically impeding crop 

production, such subsurface drainage systems are commonly employed (Hoeft et al., 2000). 

Conservation tillage and no-till practice have been shown to minimize surface water runoff and 

soil erosion, and as a result, help reduce the effects of nutrient runoff on water resources. By

improving soil quality, the consequent increase in soil organic matter promotes the binding of 

nutrients, as well as pesticides and herbicides, to soil and prevents their loss to surface waters 

and groundwater from runoff, erosion, and leaching (Leep et al., 2003).

2.3.2 Soil Quality

Arable land supports a rich and complex community of below-ground microorganisms and 

arthropods. The interaction between the below-ground community, plant root suture, and 

organic residues in the soil is central to a variety of dynamic soil ecological processes, including 

the decomposition of organic material, subsequent nutrient cycling and release, and the 

associated maintenance of soil structure and composition.

Soil Type

Soil texture and structure are key components determining water availability in soils which, in 

turn, affects soybean root depth and density. Soybeans are grown on a variety of soil types, 

ranging from small particles (clay), medium particles (silt), and large particles (sand). Silt loam 

particles’ medium size, good aeration, fertility, high water-holding capacity and abundance of 

organic matter make it the ideal soil for soybean cultivation (Hoeft et al., 2000). As mediumtextured soils are able to hold more available water, the soybean roots in medium textured soils 

are denser and extend to a typical depth of 1.2 meters. By contrast, soils that are more compact 

(e.g., clayey soils) hold less water and, as a result, the soybean plant root mass is less dense and 

shallower. The disadvantages of clay soils include their tendency to clump and impede drainage 

when tilled at too low or too high moisture levels, leading to less aeration and a tendency toward 

erosion (Hoeft et al., 2000). The ideal pH for soybean growth is 6.0, with yield declining at a pH

less than or equal to 5.8 (Heatherly et al., 2009; Hoeft et al., 2000).
33

The soils found in the Northern Tier states are of varying types but predominately Mollisols and 

Alfisols. Soil surface layers of Mollisols are generally thick and dark and are among some of the 

most important soil types in both world and U.S. agriculture (McDaniel, 2011). Alfisols may

typically have a layer of clay beneath a surface layer of relatively high fertility (McDaniel, 2011; 

Soil Survey Staff, 1999, 2010; US-EPA, 2009). Additionally, another type of soils found in the 

five states of interest are Vertisols which are clay soils that expand when wet and shrink with 

cracking when drying (Soil Survey Staff, 1999). Also, other soils present in this region include 

Entisols, many of which are sandy or have very shallow surface layers, and Histosols, having 

high organic material in upper layers, and which overlay rock, cinders or pumice.

Soil Disturbance/Degradation

Cultivation of soybean directly impacts the qualitative and quantitative attributes of soil. For 

example, conventional tillage and mechanized harvesting machinery may disturb and expose the 

top soil surface layer, leaving the land prone to degradation. In turn, degradation of soil structure 

and composition may lead to decreased water retention, a decrease in soil carbon aggregation 

and net positive carbon sequestration, and increased emission of radiatively-active gases that 

contribute to the greenhouse effect (e.g., carbon dioxide (CO2) and nitrous oxide (N2O)) (Lal and 

Bruce, 1999; US-EPA, 2010a). Additionally, land that is prone to degradation is also more 

likely to negatively affect water resource quality and communities of organisms dependent on 

those water resources.

Soil Biota

Mutualistic relationships with beneficial microorganisms are essential to soybean growth. Being

a legume plant, the soybean plant fixes a significant portion of its own nitrogen through the 

symbiotic relationship with the nitrogen-fixing Bradyrhizobia bacteria (Bradyrhizobium 

japonicum) that live in soybean root nodules (Hoeft et al., 2000). The soybean root nodules 

contain colonies of bacteria which take gaseous nitrogen from the atmosphere and fix it in forms 

easily used by the soybean plant. Because the nitrogen-fixing bacteria are not native to U.S. 

soils and would not normally be found in these soils, soybeans are frequently inoculated with 

these bacteria prior to planting, especially if soybean has not been grown in a field for three to 

five years (Pedersen, 2007).

In addition to Rhizobium, beneficial microorganisms to the soybean plant include mycorrhizal 

fungi that attach to soybean roots and extend hyphae deep into the soil, effectively increasing 

soybean access to nutrients and water (Purves et al., 2004). In addition to increasing soybean 

access to water and nutrients, mycorrhizal hyphae also facilitates pore creation in soil through 

particle aggregation, an important effect in clay soils that do not aerate well (Heatherly and 

Hodges, 1999).

Both Rhizobium and mycorrhizae aid plant survival during drought. Mycorrhizal-colonized nonirrigated soybeans have shown a 10 percent increase in yield compared to non-colonized nonirrigated soybeans during a drought period. These two mutualistic symbioses have been shown 

to occur concurrently, with mycorrhizae having a positive impact on Rhizobium nodulation and 

the nitrogen-fixing activity of nodules present on the soybean plant. These soybean plants also 

provided a greater yield (Heatherly and Hodges, 1999).
34

2.3.3 Air Quality

Agricultural Air Pollutants and Emissions Sources

Agricultural impacts on air quality can be measured by concentrations of specific air pollutants, 

such as the Clean Air Act (CAA) National Ambient Air Quality Standards (NAAQS) criteria 

pollutants, greenhouse gases (GHGs), volatile organic compounds (VOCs), pesticides, odors, 

and airborne allergens. The seven NAAQS criteria pollutants are carbon monoxide (CO), lead, 

nitrogen dioxide (NO2), particulate matter between a nominal 2.5 and 10 micrometers in 

aerodynamic diameter (PM10), particulate matter less than a nominal 2.5 micrometers in 

aerodynamic diameter (PM2.5), ozone (O3), and sulfur dioxide (SO2) (US-EPA, 2010c). The 

main GHGs that enter the atmosphere because of agricultural activities include: carbon dioxide 

(CO2), methane (CH4), and nitrous oxide (N2O). In addition to CO2, ammonia is also another 

trace gas from agriculture (Krupa et al., 2006). 

Emissions from crop agriculture can be broken down into two main categories  emissions 

related to working fields, such as dust and equipment emissions, and emissions from the soil and 

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

include CO, nitrogen oxides, reactive organic gases, particulate matter, and sulfur oxides (USEPA, 2010b). Agriculture activities (e.g., field preparation, planting, and harvesting) may

generate dust plumes (PM10 and PM2.5) (Holmén et al., 2006). For example, peak levels of 

particulate concentrations coincide with the peak agricultural harvest season in California’s 

Central Valley (Giles et al., 2006).

Primary agricultural air emission sources of other pollutants include soil particulates associated 

with tillage; smoke from agricultural burning, pesticide drift from spraying; and aerial 

application of pesticides which all may cause air quality impacts by drift and diffusion. 

Atmospheric wet and dry deposition of nitrogen, mineral nutrients, and organic compounds to 

cropping systems can have feedback effects on trace gas emissions from fields (Krupa et al., 

2006). Agricultural pesticides may also enter the atmosphere through volatilization from soil 

and plant surfaces and through wind erosion and can be returned to the surface through 

precipitation or dry deposition processes (Vogel et al., 2008).

Primary agricultural air emission sources of GHGs include: CO2 from agricultural burning; 

vehicle exhaust associated with equipment used in tillage and harvest; and N2O emissions from 

the use of nitrogen fertilizer (Aneja et al., 2009; Hoeft et al., 2000; US-EPA, 2010a; USDANRCS, 2006a). Agriculture, including land-use changes for farming, is responsible for an 

estimated 17 to 32 percent of all human-induced GHG emissions. Herro (Herro, 2008) proposes 

that if agriculture practices were modified, significant reductions in the release of GHGs would 

be expected. Compliance and enforcement of emission rules may be regulated at state, local, and 

federal levels, but for most GHGs there are no applicable regulations of these gases arising from 

agricultural burning.

Agricultural burning generates smoke that consists of particulate matter, including a complex 

mixture of carbon, tars, liquids, and different gases that are harmful to the human environment 

(US-EPA, 2011a) The major pollutants from burning on natural lands are particulates, carbon 
35

monoxide, and volatile organics. Nitrogen oxides are emitted at rates of from 1 to 4 grams per 

kilogram (g/kg) burned, depending on combustion temperatures (US-EPA, 2011a)

Burning of soybean crops is usually not recommended by State Extension Services, but burning 

of corn preceding a corn crop in a corn-soybean rotation is sometimes indicated (Minnesota 

(Rehm, 2009); North Dakota, (Franzen and Nowatzki, 2009)). More likely, agricultural fires in 

soybean acreage occur as accidental events in hot and dry fall conditions (Sawyer, 2000). These 

fires are more likely to occur in corn, but fires in rotation crops such as wheat and soybean may

also occur (Gelderman, 2009). Field burning of corn produces particulate matter of 11.7 g/kg 

PM2.5, defined by EPA as those fine particles ≤ 2.5 micrometers (μm) in diameter (Li et al., 

2007). Within the affected area for this EA, there are only two non-attainment areas for PM2.5:

three-county Milwaukee-Racine, WI area and the seven-county Detroit-Ann Arbor, MI area (USEPA, 2011b).

Greenhouse Gases

Primary agricultural air emission sources of GHG include: CO2 from agricultural burning; 

vehicle exhaust associated with equipment used in tillage and harvest; and nitrous oxide 

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

2010a; USDA-NRCS, 2006a). Agriculture, including land-use changes for farming, is 

responsible for an estimated 6% of all human-induced greenhouse gas (GHG) emissions in the 

U.S. (US-EPA, 2010a). Agricultural emissions sources of GHGs include:

 Livestock are responsible for the largest fraction of methane emissions (80% of total 

methane via enteric fermentation and manure management) (US-EPA, 2010a).

 Agricultural equipment (e.g., irrigation pumps and tractors) release carbon monoxide,

nitrogen oxides, reactive organic gases, particulate matter, and sulfur oxides (US-EPA, 

2010a). 

 Agricultural soil management practices, including nitrogen-based fertilizer application 

and cropping practices, are the largest source of U.S. N2O emissions. Croplands account 

for 69% of the total N2O emissions attributable to agricultural land uses (US-EPA, 

2010a).

 Carbon dioxide (CO2) is also a significant GHG gas associated with several agricultural 

practices, including classes of crops, location and soil types associated with the practices, 

and energy consumption (Cole et al., 1997; US-EPA, 2010a). 

GHG may be indirectly affected by the class of crop planted and soil types; trees, grasses and 

field crops each play a slightly different role in the global cycle of GHG (Cole et al., 1997; 

Freibauer et al., 2004; US-EPA, 2010a). For example, emissions of nitrous oxide, produced 

naturally in soils through microbial nitrification and denitrification, can be dramatically 

influenced by fertilization, introduction of grazing animals, cultivation of nitrogen-fixing crops 

and forage, retention of crop residues (i.e., no-till conservation), irrigation, and fallowing of land 

(US-EPA, 2010a). These same agricultural practices can influence the decomposition of carboncontaining organic matter sequestered in soil, resulting in conversion to carbon dioxide loss to 

the atmosphere (US-EPA, 2010a). Conversion of cropland to pasture results in an increase in 

carbon and nitrogen sequestration in soils (US-EPA, 2010a).
36

The EPA has also identified regional differences in GHG emissions associated with agricultural 

practices on different soil types, with high mineral content soils responding to GHG differently 

than high-organic content soils (US-EPA, 2010a). Mineral soils contain from 1 to 6% organic 

carbon by weight; conversion of such soils from their native state to agricultural uses can cause 

as much as 50% of the natural organic carbon to decompose and be released to the atmosphere 

(US-EPA, 2010a). In contrast, organic soils may contain as much as 20% carbon by weight (USEPA, 2010a). When such organic soils are prepared for agricultural use, the soils are aerated, 

accelerating decomposition and release of CO2 to the atmosphere (US-EPA, 2010a).

Tillage, Fertilization, and Greenhouse Gases

Tillage contributes to the release of GHG because of the loss of CO2 to the atmosphere and the 

exposure and oxidation of soil organic matter (Baker et al., 2005). Herbicide-tolerant crops may

encourage increases in the adoption of conservation tillage programs whose consequences may

include reductions of many of these emission concerns. Special conservation tillage field 

equipment can often perform the equivalent functions of several standard implements, reducing 

the necessity for multiple passes through the field. Implementing CT practices can lead to both 

economic and production quality benefits, as well as having positive environmental impacts 

(USDA-NRCS, 2006b). Tillage contributes to the release of GHG because carbon is lost as CO2

to the atmosphere, and because of exposure and then oxidation of soil organic matter (Baker et 

al., 2005).

GHGs and Nitrogen Fertilizer

Nitrous oxide emissions are released following use of nitrogen fertilizer and the action of soil 

microbes on soil constituents. Massive overuse of fertilizers is the biggest contributor to these 

emissions within the industry; more than half of all fertilizer applied to fields ends up in the 

atmosphere or local waterways each year. The equivalent of 2.1 billion tons of carbon dioxide in 

the form of nitrous oxide, a GHG almost 300 times more potent than CO2, is emitted because of 

fertilizer use (Herro, 2008).

Because soybean is able to fix atmospheric nitrogen by means of symbiotic nodulating bacteria, 

nitrogen fertilization is often not indicated as a good management practice (Rehm et al., 2001; 

Staton and Warncke, 2009). Less than 40% of soybean acres across the U.S. receive fertilizer 

application, which is appreciably lower than other major crops, such as corn and cotton (USDAERS, 2010e). Considering these observations and recommendations, soybean production is most 

likely not a large contributor to GHG emission through nitrogen fertilizer application.

Pesticide Application

Aerial application of pesticides may cause impacts from drift and diffusion. Pesticides may

volatilize after application to soil or plant surfaces and move following wind erosion (Vogel et 

al., 2008). Airborne chemicals may partition between gas and particle phase, be transported 

through wind, and then be deposited again by rainfall or particulate settling. Vogel et al.(Vogel 

et al., 2008) from measurements of pesticide content in 4 states estimate that 2% of all applied 

agricultural chemicals are re-deposited via rainfall. 
37

The persistence of pesticides in the atmosphere may be an air quality issue. Air concentrations of 

pesticides are typically greatest within the immediate treatment area, although, evidence also 

indicates that airborne chemicals may be detected at distances further from treated fields. When 

rainwater is sampled, pesticides that were used beyond the local watershed, that is, from the 

intermediate and larger watersheds may be well represented among the analytes (Vogel et al., 

2008). Whether pesticides are applied by ground or aerial spraying or by mechanical application 

to the plant surface, chemicals move to their intended and unintended targets through air, moving 

as droplets, dry particles or vapors (Carlsen et al., 2006 ; Ravier et al., 2005). The distance 

traveled depends upon their chemical and physical nature, method of application, and the 

atmospheric conditions at time of treatment. All these influence their concentration and ultimate 

fate (Carlsen et al., 2006 ).

2.3.4 Climate Change

Climate change represents a statistical change in climate conditions, and may be measured across 

both time and geographic space. U.S. agriculture may affect climate change through various 

facets of the crop cultivation process. Combustion of fossil fuels in mechanized farm equipment, 

fertilizer application, and decomposition of agricultural waste products may all contribute GHGs 

to the atmosphere (Aneja et al., 2009). GHGs collectively function as retainers of solar radiation,

and agricultural related activities are recognized as both direct (e.g., exhaust from equipment) 

and indirect (e.g., agricultural-related soil disturbance) sources of CO2, CH4, and N2O (US-EPA, 

2010a)

As summarized by the Intergovernmental Panel on Climate Change (IPPC) (Technical Summary, 

Working Group I: The Physical Science Basis (IPCC, 2007)), the atmospheric persistence of 

long-lived GHGs, including CO2, CH4, and NO2, may lead to extensive climate change because 

of altered cycling between atmosphere, ocean and land and radiative forcing causing climate 

change (IPCC, 2007). The U.S. agricultural sector is identified as the second largest contributor 

to GHG emissions, ranking only behind the energy sector (i.e., electricity production, 

transportation, and related activities) (US-EPA, 2010a).

Agricultural crop commodities may also affect dynamic geophysical soil processes, such as 

carbon turnover and sequestration, through tillage and cropping system practices. In general, 

reduced/conservation tillage practices favor more stable and increased carbon sequestration in 

the agro-environment (Lal, 2011). The impacts of GE crop varieties on climate change are most 

likely dependent on the selected cropping systems and production practices, geographic 

distribution of activities, and individual grower decisions.

Climate Change Impacts on Crop Production

Climate change may also affect agricultural crop production. These potential impacts on the 

agro-environment and individual crops may be direct, including changing patterns in 

precipitation, temperature, and duration of growing season, or may cause indirect impacts 

influencing weed and pest pressure (Hatfield et al., 2011a; Rosenzweig et al., 2002).

In response to climate change, the current range of weeds and pests of agriculture is expected to 

change. In response to these new ranges, current agricultural practices may be required to 
38

change (IPCC, 2007). Climate change may potentially provide a positive impact to agriculture. 

The IPCC predicts that potential climate change in North America may result in an increase in 

crop yield by 5 to 20% for this century (IPCC, 2007). However, this positive impact will not be 

observed across all growing regions. The IPCC report notes that certain regions of the U.S. will 

be negatively impacted because available water resources may be substantially reduced. Note 

that the extent of climate change effects on agriculture is highly speculative. Nevertheless, North 

American production is expected to adapt to climate change impacts with improved cultivars and 

responsive farm management (IPCC, 2007).

Climate Change Impacts on Soybean Production

A number of impacts of increased temperature have been inferred from models of climate 

change. More than one model suggests that soybean yields will decline in the U.S., mediated by 

increased temperature and declining precipitation during key periods of the growing season 

(Goldblum, 2009). Besides yield penalties, increased temperatures could result in early season 

flooding and increased precipitation (which in past seasons may either delay planting, or prevent 

harvest). The changes in precipitation patterns would lead to crop losses, including soybean, of 

up to 30% in 2030 and 65% in 2090 (Rosenzweig et al., 2002). Other modeling efforts have 

suggested that before the end of the century, yields could be decreased 30 to 46%, under the 

slowest warming scenario, and up to 63 to 82% under a rapid warming scenario (Schlenker and 

Roberts, 2009). 

The cited models suggest that impacts of climate change (specifically, an overall deficit in total 

soybean yield) would exert pressure for land allocations for new soybean planting. However, the 

analysis by Mori et al. (Mori et al., 2010) suggests that land use conversion in the U.S. to 

mitigate the need for additional soybean would be unlikely. Mori et al. (Mori et al., 2010) also 

suggest that it would be Brazil, China and South America that would likely have large 

conversions to soybean production in response to lower production efficiencies elsewhere in the 

world. However, some areas of the U.S. that may experience decreased soybean yield may show 

small levels of increased production, such as the Midwest states (+1.7%), because of increased 

CO2 stimulating plant growth and cultivars with improved water use efficiency (Hatfield et al., 

2011b).

Future impacts might be mitigated by selection of varieties that showed decreased responses to 

the changed climate. As Betzelberger et al. (Betzelberger et al., 2010) note, cultivar sensitivity

to parameters such as increased ozone can have substantial deleterious impacts on soybean yield 

as well. Some tropical soybean is less susceptible than other varieties to the increased O3 that 

may typify future environmental concentrations, and the differences are measurable in several 

parameters of total biomass, crop yield and certain biochemical markers (Singh et al., 2010). In 

addition, if progress in developing drought resistant crops is maintained, additional soybean lines 

may be produced that will resist decreased precipitation expected over some U.S. soybean 

growing areas. Finally, use of different maturity group soybean with higher yield potential may

be possible, especially if early spring occurs and the growing season is lengthened, and this and 

other management strategies could recover possible yield losses (Kucharik, 2008). From an 

analysis (Goldblum, 2009) of climate change impacts on yield of corn and soybean, timing of 

increased hot weather and of precipitation can cause county by county differences within a single 

state. As has been shown in such an analysis in Wisconsin, however, increased warming in 
39

spring and fall (producing increased precipitation) versus increased temperature in summer 

(along with drought) may produce opposite impacts on soybean yield, and empirical evidence is 

needed to establish overall impacts of the anticipated variations (Kucharik, 2008).

2.4 Biological Resources

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

animals, plants, gene transfer, weeds and weediness, microorganisms, and biodiversity. This 

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

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

2.4.1 Animal Communities

Deer and groundhogs feed on soybean and cause soybean damage, while Eastern cottontail,

raccoon, Canada geese, squirrels, other rodents (such as ground squirrel) also feed on soybean 

but their damage is of less importance (MacGowan et al., 2006). Deer in large numbers, by 

browsing in soybean fields for forage, may significantly damage soybean in site specific 

circumstances, and in some areas, growers may be issued licenses to kill deer outside the regular 

hunting season to reduce crop damage (Berk A, 2008; Garrison and Lewis, 1987). Deer may also 

feed on seed left after harvest. Other animals that feed primarily on soybean include seed-feeding 

insects and rodents found in agricultural fields. Rodents, such as mice or squirrels, may

seasonally feed exclusively on soybean seeds. Thus, these animals may have a diet containing 

significant amounts of soybean seeds. Migratory birds feed on spilled soybean following crop 

harvest (Galle et al., 2009) although more birds fed on nearby corn and sunflower seed fields. 

As many as 28 desirable bird species, as well as another five which can be crop pests in 

sunflower, have been identified as resident in soybean and corn fields in the Dakotas (Gamble et 

al., 2002).

The biodiversity of insect predators of a soybean aphid in soybean fields have been studied in 

four Northern Tier states, and relative to corn and soybean, environments with abundances of 

crop and non-crop plants provided greater “biocontrol services” than does soybean (Gardiner et 

al., 2009). Total insect diversity in GE glyphosate tolerant soybean has been compared to that in 

non-GE soybean, and although mostly similar, some slight decreases of insect diversity and 

numbers were observed between rows of soybean, but attributed to reduced abundance of weeds 

in glyphosate treated plots (Imura et al., 2010). Buckelew et al. (Buckelew et al., 2000) also 

conclude that insect abundance in soybean is more related to effectiveness of weed suppression, 

rather than use of glyphosate herbicide.

Crop pest insects are considered less problematic than weeds in U.S. soybean production; 

nevertheless, insect injury can impact yield, plant maturity, and seed quality. Consequently, 

insect pests are managed during the growth and development of soybean to enhance soybean 

yield (Aref and Pike, 1998; Higley and Boethel, 1994). Insect injury in soybean seldom reaches 

levels that cause significant economic loss, as indicated by the low percentage (14%) of soybean 

acreage that receives an insecticide treatment(USDA-NASS, 2006).
40

2.4.2 Plant Communities

Soybean production systems in agriculture (i.e., the combination of management practices) are 

host to many plant species. The environment surrounding a soybean field varies in plant 

composition depending on the region. In certain areas, soybean fields may be bordered by other 

soybean varieties, corn, or other crops. In addition, fields may also be surrounded by woodlands 

and/or pasture/grassland areas, as well as aquatic environments. Therefore, the types of 

vegetation, including the variety of weeds, adjacent to a soybean field depend on the area where 

the soybean is planted. 

Annual weeds are perceived to be the greatest pest problem in soybean production, followed by

perennial weeds (Aref and Pike, 1998). Weed control in soybean is essential to optimizing 

yields. Weeds compete with soybean for light, nutrients, and soil moisture. Weeds can harbor 

insects and diseases, and also can interfere with harvest, causing extra wear on harvest 

equipment (Loux et al., 2008). The primary factors affecting soybean yield loss from weed 

competition are the weed species, weed density, and the duration of the competition. When 

weeds are left to compete with soybean for the entire growing season, yield losses can exceed 

75% (Dalley et al., 2001). 

Generally, the effects of competition increase with increasing weed density (Monsanto, 2010b). 

The time period that weeds compete with the soybean crop influences the level of yield loss. 

The later the weeds emerge, the less impact the weeds will have on yield. Soybean plants 

withstand early-season weed competition longer than corn as the soybean canopy closes earlier 

in soybean than in corn (Mallory-Smith and Zapiola, 2008). The extent of canopy closure 

regulates the availability of light to weeds and other plants that grow below the soybean. In 

addition, canopy closure occurs much sooner when soybean is drilled or planted in narrow rows. 

Eighty-six common weeds of soybean across three growing regions were identified in another 

soybean petition for nonregulated status ((Monsanto, 2010b) (Tables IX-5 and IX-6). Foxtail 

spp., pigweed, velvetleaf (Abutilon theophrasti), lambs quarters (Chenopodium album), and 

cocklebur (Xanthium strumarium) are common annual weeds in Midwest corn and soybean 

fields. However, growers consider giant ragweed (Ambrosia artemisiifolia), lambs quarters, 

Canada thistle (Cirsium arvense), cocklebur, and velvetleaf to be the top five most problematic 

weeds in corn and soybean because of the difficulty to control these weeds (Nice and Johnson, 

2005). 

Crop rotations and environment have a significant impact on the adaptation and occurrence of 

weeds in soybean. Cultural and mechanical weed control practices are important components of 

an effective weed management program (Loux et al., 2008). Crop rotation, narrow row spacing, 

and planting date are a few of the crop management practices that are implemented to provide 

the crop with a competitive edge over weeds (Monsanto, 2010b). Although the primary purpose

of tillage is for seedbed preparation, tillage is still used to supplement weed control with 

selective herbicides in soybean production. 

Herbicides provide effective and economical control of weeds in soybean. Approximately 98% 

of the soybean acreage received an herbicide application in 2006, indicating the importance of 

weed control in maximizing soybean yield (USDA-NASS, 2007b). Herbicide-tolerant soybean 
41

was introduced to provide growers with additional options to improve crop safety and/or 

improve weed control. In 2011, herbicide-tolerant soybean varieties represented 94 percent of 

planted soybeans in the U.S. (USDA-ERS, 2011a). The Roundup Ready

®

soybean system, i.e., 

planting Roundup Ready

®

soybean and applying glyphosate in crop, has become the standard 

weed control program in U.S. soybean production. In the 2006 crop year, for the surveyed 

states, 92 percent of the planted soybean acres were treated with glyphosate (USDA-NASS, 

2007b).

2.4.3 Gene Flow and Weediness

Gene flow has been defined as the “incorporation of genes into the gene pool of one population 

from one or more populations” (Stewart, 2008). Gene flow is a basic biological process in plant 

evolution and in plant breeding. Gene flow, itself, does not pose a plant pest risk (USDAAPHIS, 2010a); it does so when specific genes with plant pest potential are incorporated into a 

cultivated plant. There are two types of gene flow: horizontal and vertical. Horizontal gene 

flow is the movement of genes between disparate, unrelated species, such as between plants and 

microbes or between plants from different families (Stewart, 2008). There is no evidence that 

horizontal gene transfer can naturally occur between unrelated plant species (see, e.g., (Stewart, 

2008; Twyman, 2003)).

In plant biology, when gene flow occurs between individuals from genetically distinct 

populations of the same species and a new plant is formed, this is called vertical gene flow and 

the new plant is called a hybrid (Stewart, 2008; USDA-APHIS, 2010a). Hybridization is usually

thought of as the breeding of closely related species resulting in the creation of a plant that has 

characteristics different from either parent. When plants are moved to a new environment (with 

or without human intervention), they may hybridize with plants of a closely-related species or 

subspecies in that new location. For natural hybridization to occur between two distinct but 

related populations, the plants from the two populations must flower at the same time, they must 

be close enough so that the pollen can be carried from the male parent to the female parent, 

fertilization must occur, and the resulting embryo must be able to develop into a viable seed that 

can germinate and form a new plant (Ellstrand, 2003; USDA-APHIS, 2010a). 

Hybridization may occur in one generation, but in most cases, does not progress on its own 

through subsequent generations. If it does, and stable new populations result, the process is 

called introgression. For introgression to occur, hybridization of offspring with the parental 

types (backcrossing) must occur several times. Because hybrids of distantly related species may

not produce viable seed, introgression is much less common than hybridization. For example, in 

studies done with canola and a weedy relative, backcrossing from the hybrids to the weeds 

occurred at one-hundredth to one-thousandth the rate of the original hybridization (Stewart, 

2008). Nevertheless, when weed species are introduced to new areas, there is the potential that 

those introduced plants may hybridize with other closely related species. Novel hybrids 

therefore may be created. In addition, novel hybrids may be created through back-crossing (i.e., 

introgression) with parent species which may change the native species by incorporating nonnative genetic material. Invasive weeds can result from hybridization events, which mix genetic 

material potentially producing a wide array of genotypes. Some of these genotypes may exhibit 

increased invasive properties (USDA-APHIS, 2010a; USDA-ARS, 2008a).
42

Characteristics that favor natural hybridization between two populations include (Mallory-Smith 

and Zapiola, 2008; USDA-APHIS, 2010a):

 Presence of feral populations (domestic populations gone wild) and uncontrolled volunteers;

 Presence of a high number of highly compatible relatives;

 Self-incompatibility;

 Large pollen source;

 Large amounts of pollen produced;

 Lightweight pollen;

 Strong winds (wind pollinated);

 Large insect populations (insect pollinated); and

 Long pollen viability.

Additionally, the creation of a hybrid depends on a series of events including:

 A pathway for the gene of interest of one plant species to enter the population of the species 

to be hybridized (i.e., the parent plant and the receptor plant must be able to produce fertile 

offspring); and

 The hybridization must confer a fitness advantage that allows the gene, over multiple 

generations, to develop into a sustainable, reproducing population. 

The rate and success of gene flow is dependent on numerous external factors in addition to the 

donor/recipient plant. General external factors related to pollen-mediated gene flow include the 

presence/abundance/distance of sexually-compatible plant species; overlap of flowering 

phenology between populations; the method of pollination; the biology and amount of pollen 

produced; and weather conditions, including temperature, wind, and humidity (Zapiola et al., 

2008). Seed-mediated gene flow also depends on many factors, including the 

absence/presence/magnitude of seed dormancy; contribution and participation in various 

dispersal pathways; and environmental conditions and events. 

The genus Glycine consists of two subgenera, soja and glycine. The subgenus soja consists of 

three annual species: G. soja Sieb. and Zucc., the wild form of soybean; G. gracilis Skvortz., the 

weedy form of soybean; and G. max, the cultivated soybean. Cultivated soybean, G. max, can 

only hybridize with other members of the Glycine subgenus soja (OECD, 2000). The wild and 

weedy relatives (G. soja and G. gracilis) of soybean do not occur in the U.S. (USDA-APHIS, 

2010c). Consequently, there is no potential for gene flow from cultivated soybean plants to wild 

relatives in the U.S. (USDA-APHIS, 2010b). Glycine soja grows wild in China, Japan, Korea, 

the Russian Far East, and Taiwan and is commonly found in fields, hedgerows, roadsides, and 

riverbanks in those countries (OECD, 2000).

Although there are no wild relatives with which soybean can share transgenes, such introduced 

genes have the potential to move within cultivated varieties of soybean. The potential for 

outcrossing can be defined as the ability of genes to escape to other soybean populations. 

Soybean is a highly self-pollinating species with a cross-pollination rate of less than one percent 

in plants grown in close proximity (Caviness, 1966; OECD, 2000). Cross-pollination at distances 
43

greater than 4.6 meters (m) from a pollen source has been rarely observed, although it has been 

reported that insects can sometimes transfer the pollen that distance or more (Caviness, 1966).

Soybean is not native to the U.S. and there are no feral or weedy relatives. Soybean is a selfpollinated species, propagated by seed (OECD, 2000). Pollination typically takes place on the 

day the flower opens. The soybean flower stigma is receptive to pollen approximately 24 hours 

before anthesis (i.e., the period in which a flower is fully open and functional) and remains 

receptive for 48 hours after anthesis. Anthesis normally occurs in late morning, depending on the 

environmental conditions. The pollen usually remains viable for two to four hours, and no viable 

pollen can be detected by late afternoon. Natural or artificial cross-pollination can only take 

place during the short time when the pollen is viable. As a result, soybean is considered to be a 

highly self-pollinated species, with cross-pollination to adjacent plants of other soybean varieties 

occurring at very low frequency (0 to 6.3%) in adjacent plants (Caviness, 1966; Ray et al., 2003; 

USDA-APHIS, 2010c; Yoshimura et al., 2006). 

Potential of soybean for weediness is low, and even if gene flow occurred from this variety to 

other commercial soybeans, the trait (fatty acid composition changes) would not likely confer a 

selective advantage to the recipient soybean. Specific traits of soybean also limit their potential 

as weeds. Mature soybean seeds have no innate dormancy, are sensitive to cold, and are not 

expected to survive in freezing winter conditions (Raper Jr. and Kramer, 1987). The only known 

propagation method for soybean is through seed germination. Because there are no reports of 

vegetative propagation under field conditions in the U.S., human movement of soybean seed is 

the only possible route to establishing the plant outside growing areas. Volunteer plants that 

might grow in previously planted fields or from spilled seed under some favorable environmental 

conditions can be easily controlled mechanically or with herbicides (Zollinger, 2010). Soybean is 

not weedy (Holm et al., 1977), is not found outside of cultivated areas, and does not compete 

well with other cultivated plants (Hymowitz and Singh, 1987).

Horizontal gene transfer and expression of DNA from MON 87769 soybean to soil bacteria are 

unlikely to occur for several reasons (USDA-APHIS, 2010c). First, many genomes (or parts 

thereof) have been sequenced from bacteria that are closely associated with plants including 

Agrobacterium and Rhizobium (Kaneko et al., 2000; Kaneko et al., 2002; Wood et al., 2001). 

There is no evidence that these bacteria contain genes derived from plants. Second, in cases 

where review of sequence data suggest that horizontal gene transfer might have occurred, these 

events are likely to have occurred over an evolutionary time scale, i.e., on the order of millions 

of years (Brown, 2003; Koonin et al., 2001; USDA-APHIS, 2010b). Third, transgene DNA 

promoters and coding sequences are optimized for plant expression, not prokaryotic bacterial 

expression. Thus, even if horizontal gene transfer were to occur, proteins corresponding to the 

transgenes are not likely to be produced. Fourth, the FDA has evaluated horizontal gene transfer 

from the use of antibiotic resistance marker genes, and concluded that the likelihood of transfer 

of antibiotic resistance genes from plant genomes to microorganisms in the gastrointestinal tract 

of humans or animals (e.g., E. coli), or in the environment, is remote (US-FDA, 1998).

2.4.4 Microorganisms

Soil microorganisms play a key role in soil structure formation, decomposition of organic matter, 

toxin removal, nutrient cycling, and most biochemical soil processes (Garbeva et al., 2004). 
44

They also suppress soil-borne plant diseases and promote plant growth (Doran et al., 1996). The 

main factors affecting microbial population size and diversity include soil type (texture, 

structure, organic matter, aggregate stability, pH, and nutrient content), plant type (providers of 

specific carbon and energy sources into the soil), and agricultural management practices (crop 

rotation, tillage, herbicide and fertilizer application, and irrigation) (Garbeva et al., 2004). Plant 

roots, including those of soybean, 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).

Members of the bacterial families Rhizobiaceae and Bradyrhizobiaceae form a highly complex 

and specific symbiotic relationship with leguminous plants, including soybean (Gage, 2004). 

The nitrogen-fixing plant-microbe symbiosis results in the formation of root nodules, providing 

an environment in which differentiated bacteria called bacteroids are capable of reducing or 

fixing atmospheric nitrogen. The product of nitrogen fixation, ammonia, then can be used by the 

plant. In soybean, atmospheric nitrogen is fixed into ammonia through a symbiotic association 

with the bacterium Bradyrhizobium japonicum. As a result of this relationship, nitrogen 

enhancement of soils may only be needed in a limited number of situations for maximal yield of 

soybean (Ferguson et al., 2006). 

It is necessary that an adequate soil population of nodulation-inducing bacteria be found in the 

soil planted to soybean. As noted in the earlier section on fertilization and effects on air and 

water, these bacteria must be supplied if a soybean crop has not been recently grown on the field. 

Although the bacteria persist for several years in soil, their numbers may not be sufficient to 

insure adequate nodulation (Bottomley, 1992). Various commercial sources of inoculants such 

as multiple strains of Bradyrhizobium can be applied to seeds just before planting, many with 

similar results (Beuerlein, 2005). From one season to the next, the inoculated bacteria in soil 

may change characteristics or phenotypes and diverge from traits expressed by the original 

culture (Farooq and Vessey, 2009), and if nodulation is not adequately accomplished, growers 

may need supplemental nitrogen after plant growth has begun (Ferguson et al., 2006).

2.4.5 Biodiversity

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

(Wilson, 1988). In assessing the plant and animal species of the affected area, the animal and 

plant sections of this EA named the most common animal species, including mammals, avian 

species, invertebrates and soil dwelling biota and similarly, plant species that are represented by 

prominent weeds within the fields and by other non-crop plants at the margins. These are 

indicators of the overall environment, but do not identify the interaction of all plants, animals, 

and microorganisms in an ecosystem, which is the definition of biodiversity (Wilson, 1988). 

Biodiversity provides valuable genetic resources for crop improvement (Harlan, 1975) and also 

provides other functions beyond food, fiber, fuel, and income. These include pollination, genetic 

introgression, biological control, nutrient recycling, competition against pests by 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).
45

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; and 4) extent of isolation of the agroecosystem 

from natural vegetation (Altieri, 1999; Palmer et al., 2010). The reintroduction of woodlots, 

fencerows, hedgerows, wetlands, etc., has been used to reintroduce biodiversity into large scale 

monocultures. Other enhancement strategies include intercropping (the planting of two or more 

crops simultaneously to occupy the same field), agroforestry, crop rotations, cover crops, notillage, composting, green manuring (growing a crop specifically for the purpose of 

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

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

(Altieri, 1999). 

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. The use of 

broad-spectrum insecticides/herbicides is one of the most severe constraints for biological 

diversity in crops (USDA-APHIS, 2010a). Tillage, seed bed preparation, planting of a 

monoculture crop, pesticide use, fertilizer use, and harvest may all limit the diversity of plants 

and animals (Lovett et al., 2003). 

Tillage practices may impact biodiversity, and the type of tillage may be dependent upon 

adoption of a GE herbicide tolerant crop. For example, while production of a non-GE field crop 

may typically be accomplished using intensive tillage, a GE crop with herbicide tolerance traits 

may facilitate use of conservation tillage and thus the crop type may lead to the indirect effects 

observed with planting the GE crop. Thus, comparisons of tillage effects may actually reflect 

such indirect effects. The majority of soybeans are under some type of conservation tillage 

(~63% (CTIC, 2010b)); the conservation tillage rates for non-transgenic soybean would likely 

be substantially less if there were no herbicide tolerance traits facilitating use of this tillage. 

Weed management with herbicide-tolerant GE crops using over the top herbicides are more 

efficient than conventional tillage. Tillage alone changes bird species diversity, and in one 

analysis, four times as many species nested in no-till compared to tilled fields (Basore et al., 

1986). Waste soybean seed left in fields after harvest may in some cases be a source of food for 

birds and other wildlife in fall, winter or spring (Galle et al., 2009), and may total 48 to 63 kg/ha 

in untilled crops, and 12 kg/ha in tilled crops (Warner et al., 1985). 

Species diversity and abundance in soybean agro-ecosystems may differ between the three 

soybean production methods: conventional with herbicide-tolerant GE varieties (mostly using 

glyphosate), conventional with non-GE varieties (using a variety of herbicides), and organic

(without the use of herbicides). Many studies over the last 10 years have investigated the 

differences in biological diversity and abundance between GE and non-GE fields, particularly 

those GE crops that are resistant to insects (e.g., Bt crops) or herbicides (e.g., glyphosatetolerant or glufosinate-tolerant crops.) Different studies have indicated potential decreases in 

biological diversity or abundance due to GE crops, or the presence of a pesticidal protein in 

some GE crops (Bt) (e.g., (Hansen Jesse and Obrycki, 2000; Pilcher et al., 2005; Ponsard et al., 

2002). Other studies of GE crops, such as Bt corn, when compared to non-GE crops sprayed 

with insecticides demonstrate that GE crops do not cause any changes in arthropod abundance 

or diversity (e.g., (Bitzer et al., 2005; Chen et al., 2008; Marvier et al., 2007; Romeis et al., 
46

2006; Torres and Ruberson, 2005; Wolfenbarger et al., 2008)). While metastudies have noted 

an increase in abundances and of some species of organisms in organic crops, one conclusion 

has been that “positive effects of organic farming on abundance were prominent at the plot and 

field scales, but not for farms in matched landscapes” (Bengtsson et al., 2005). These authors 

propose that efforts to enhance biodiversity should be focused on landscapes, not smaller sites 

such as on fields. Given the small number of organic soybean farms, and that MON 87769 

soybean will have no impacts on this production system, comparisons of biodiversity effects of 

organic and conventional agriculture will not be further analyzed in this EA.

Farm-scale comparisons were made of three herbicide tolerant crops with conventionally 

managed controls—beets, winter oilseed rape and maize (Squire et al., 2003). In two herbicide 

tolerant crops (beets and winter oilseed rape), weed biomass was significantly reduced over 

those in the non-GE varieties (Heard et al., 2003). Decreases were detected in invertebrate 

populations using the weeds as a food source or refuge in the rape and beet herbicide tolerant 

crops, but not in herbicide tolerant maize (Hawes et al., 2003). As weed biomass was reduced 

(whether in GE plants or the non-GE control) the herbivores, pollinators and natural enemies 

generally declined as well (Buckelew et al., 2000; Hawes et al., 2003). Abundance of 

yellowhammer and granivore birds was also greater on non-GE than herbicide tolerant beet and 

rape crops (Chamberlain et al., 2007), but herbicide tolerant maize also showed the same 

pattern. Correlating weed diversity and changes in agricultural practices demonstrates that 

weeds have a broad role in supporting certain types of biological diversity within farmed fields 

(Marshall et al., 2003). 

Arthropod abundance may not depend upon crop variety (either herbicide-tolerant or non-GE 

corn) but either variety may increase species diversity during different times of the year (e.g., 

(Brooks et al., 2005; Haughton et al., 2003; Hawes et al., 2003; Roy et al., 2003; Wolfenbarger 

et al., 2008)). Biodiversity of insect predators of a soybean aphid in soybean fields have been 

studied in four Northern Tier states, and relative to corn and soybean, environments with 

abundant crop types and non-crop plants provided greater “biocontrol services” than does 

extensively planted soybean (Gardiner et al., 2009). Total insect diversity in GE glyphosate 

tolerant soybean has been compared to that in non-GE soybean, and although mostly similar, 

some slight decreases of insect diversity and numbers were observed between rows of GE 

soybean, but attributed to reduced abundance of weeds in glyphosate treated plots (Imura et al., 

2010). Buckelew et al. (Buckelew et al., 2000) also conclude that insect abundance in soybean 

is more related to effectiveness of weed suppression, rather than use of glyphosate herbicide. 

For some predator insects (biocontrol organisms) on soybean, the genetic diversity of the host 

soybean is relevant to predicting predator lifespan, and these impacts are not mediated by weeds 

(Lundgren et al., 2009). Additionally, the comparator chosen may be quite specific to certain 

relationships, and subtle impacts may be related to use of one specific herbicide (such as 

Atrazine) (Brooks et al., 2005), as was demonstrated in the previous farm scale evaluations 

(Heard et al., 2003). 

Soil-inhabiting organisms also respond to changes imposed by constraints of the management 

system, such as those that include GE glyphosate tolerant crops. In the case of soil 

microorganisms, variations in number and species can be observed following many ‘normal’ 

agronomic interventions (Kowalchuk et al., 2003), but ascertaining those that are relevant to 

types of production systems require detailed analysis. From 10 years of observations, Kremer 
47

and Means (Kremer and Means, 2009) found increased colonization by Fusarium of glyphosate 

tolerant soybean roots following application of glyphosate, and increases of fluorescent 

Pseudomonas spp. Kremer and Means (Kremer and Means, 2009) also summarized findings of 

theirs and others that showed that GE glyphosate tolerant soybeans reduced nodulation and 

nitrogen fixation, but did not affect grain yields (Bohm et al., 2009). However, because many of 

the variations in soil microbial populations or diversity can be produced by many types of 

impacts, Kowalchuk et al. (Kowalchuk et al., 2003) propose that experimentally, systematic 

analysis of indicator groups representing different functions be assessed, and that rigorous 

methods of analysis be required to demonstrate impacts.

Since biological diversity can be defined and measured in many ways, APHIS considers 

determining the level of biological diversity in any crop to be complex and difficult to achieve 

concurrence. Another complication with biodiversity studies is separating expected impacts

from indirect impacts. For example, reductions of biological control organisms are seen in some 

Bt-expressing GE crops, but are caused by reduction of the pest host population following 

transgenic pesticide expression in the transformed crop plant.

2.5 Human Health

2.5.1 Public Health

Public health concerns surrounding GE soybean primarily involve the human consumption of GE 

soybean products. Non-GE soybean varieties, both those developed for conventional use and for 

use in organic production systems, are not routinely required to be evaluated by any regulatory

agency in the U.S. for food safety prior to release in the market. Under the FFDCA, it is the 

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

properly labeled.

Food derived from GE soybean must be in compliance with all applicable legal and regulatory

requirements. GE organisms for food may undergo a voluntary consultation process with the 

FDA prior to release onto the market. Although a voluntary process, thus far, 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.

As noted by the National Research Council (NRC), unexpected and unintended compositional 

changes arise with all forms of genetic modification, including both conventional hybridizing 

and genetic engineering (NRC, 2004) The NRC also noted that at the time, no adverse health 

effects attributed to genetic engineering had been documented in the human population. 

Reviews on the nutritional quality of GE foods have generally concluded that there are no 

significant nutritional differences in non-GE versus GE plants for food or animal feed (Faust, 

2002; Flachowsky et al., 2005).
48

Monsanto has provided the FDA with information on the identity, function, and characterization 

of the genes, including expression of the gene products. The submittal to the FDA included 

information on the safety of the altered fatty acid profile in MON 87769 soybean oil, including a 

dietary risk assessment. Monsanto initiated the consultation process with FDA for the 

commercial distribution of MON 87769 and submitted a safety and nutritional assessment of 

food and feed derived from MON 87769 to the FDA on March 23, 2009 (BNF No. 00117). FDA 

is currently evaluating the submission (Monsanto, 2010b). SDA soybean has been accepted as 

GRAS (GRN No. 000283) after FDA accepted the notice in September 2009 (US-FDA, 2009a); 

SDA is to be used as an ingredient in baked goods and baking mixes, breakfast cereals and 

grains, cheeses, dairy product analogs, fats and oils, and so forth that will have 375 mg of 

stearidonic soybean oil per serving (US-FDA, 2009b).

2.5.2 Human Dietary Health

Soybean protein is used in food production to enhance nutrition and also to supply functional 

properties. In breakfast cereals and pasta, it enhances protein content (United Soybean Board, 

2009). In baked goods, soups, meats and poultry it may emulsify, absorb fats and water, provide 

adhesion or cohesion properties, and in many other products it may aerate, add texture, assist in 

film or dough formation, increase shelf life and improve richness. Besides uses of soybean for 

functional properties, other foods are predominantly soy, such as soy beverages, tofu, textured 

vegetable protein items (simulated meats), such as burgers, hot dogs, crumbles, nuggets, green 

vegetable soybeans (edamame), and soy flour as a primary constituent of many foods and 

numerous other products (USB, 2011c).

Soybean oil achieved prominence as a food oil after cottonseed oil and lard were overtaken in the 

1950s and by 2000, and soybean oil was found in almost 61% of the liquid oils, margarines, and 

shortening by 2000 (O'Brien, 2004). Thus, soybean oil is the principal food oil used in the U.S. 

The oil has high versatility for food processing and formulating, because it can be processed with 

low losses, and is high in essential fatty acids (O'Brien, 2004). 

Table 9. Percentages of linoleic and linolenic acid in various vegetable oil sources and 

U.S. consumption.

Oil type

Linolenic acid 

as % fatty acid 

- typical value

of omega-3

Linoleic acid

as % fatty acid

- typical value

of omega-6

U.S. 

consumption 

2000

(millions 

pounds)

Soybean 7.6 53.7 16,210

Canola 8.8 21.0 1,744

Canola-High Oleic* 3 14 NA

Corn 1.2 59.6 1,711

Sunflower* <1 65 --
49

Coconut 0.0 1.6 968

Cottonseed 0.7 54.4 674

Palm 0.4 10.1 375

Sources: (O'Brien, 2004) and * (Orthoefer, 2005).

Soybean contains two apparently essential polyunsaturated fatty acids, an omega-3 (linolenic: 

C18:3) and an omega-6 (linoleic: C18:2), in appreciable quantities. Another principle fatty acid 

constituent is the monounsaturated fatty acid, oleic acid (C18:1). Two other principle fatty acids 

include saturated ones, stearic (C18) and palmitic (C16).

DHA (22:6 n-4) and EPA (20:5 n-3) are highly beneficial fatty acids that may support good 

human health or correct health concerns, but are not represented in soy oil. In a review of the 

literature, Wijendran and Hayes (Wijendran and Hayes, 2004) showed that DHA and EPA are 

important contributors to good cardiovascular health. Additional benefits may include 

preventing aging-related cognitive decline according to Cunnane et al. (Cunnane et al., 2009). 

Hamer et al. (Hamer et al., 2005) summarized additional evidence that these fatty acids when 

added to the diet may improve health status for other conditions as well. The omega-3 oil, 

linolenic acid, can be metabolized by human biosynthetic processes to the fatty acids EPA and 

DHA, but not at sufficiently high rates to provide what may be healthful intake levels of the 

desirable EPA and DHA (Burdge and Calder, 2005). 

The biosynthesis of SDA to EPA in humans has been studied, and it is far more efficient than 

biosynthesis of EPA from alpha linolenic acid, a typical soybean fatty acid. Thus, James et al. 

(James et al., 2003) showed that if the incorporation of EPA into erythrocytes and plasma was 

assigned a value of 1.0, EPA incorporation following SDA administration occurred with an 

efficiency of 0.3, and incorporation following alpha linolenic acid (soybean constituent), 0.07. 

To attain recommended intake rates of EPA, populations should consume 1.5 g/day of SDA. 

These levels could be achieved if all typical vegetable oils consumed, including cooking oil, 

margarine, salad oil and mayonnaise contained about 10% SDA (James et al., 2003).

While fish oils are a practical source of EPA and DHA for human health, omega-3 fatty acids 

from vegetable sources are an ecologically sustainable alternative. This source relies on 

conversion of SDA by human metabolism into the healthful fatty acids. Sourcing these fatty 

acids from soybean spares fish which may be in reduced supply because of overfishing of 

resources in world oceans. About 80% of the market for food and supplement use of omega-3 

fatty acids is provided by fish oils (Packaged Facts (Market Research Group LLC), cited in 

(Daniells, 2011)). Krill are also rich in EPA and DHA (some species with around 30% of these 

as a percentage of fatty acids (Linder et al, 2010) and are becoming an increasing source of these 

highly unsaturated fatty acids (Starling, 2011). EPA and DHA are also produced by yeast such 

as Yarrowia lipolytica , a species which also synthesizes food grade citric acid (Du Pont, 2011). 

Algae produced in contained ponds are currently a source of DHA and other fatty acids in foods 

and supplements (Martek, 2010). SDA is an infrequent fatty acid in plants, but may be found in 

up to 14% concentrations in Ribes nigrum, and Primula and Echium species (Aitzetmüller and 

Werner, 1991). Soybean is one of the most economical oil sources, and development of these 

other plants as a SDA source would not be an option to be taken over a short term, nor likely to 

produce inexpensive specialty oil. In the U.S., the market for omega-3 fatty acids for functional 
50

foods is $4 billion and for supplements is $1.3 billion (Packaged Facts (Market Research Group 

LLC), cited in (Daniells, 2011)).

One issue that is relevant to human health is the more rapid oxidation of SDA and other 

polyunsaturated omega-3 fatty acids compared to the less unsaturated fatty acids (Jacobsen et 

al., 2008). A consequence of this oxidation is development of free radicals and bioactive 

aldehydes, and the production of off-flavors (Jacobsen et al., 2008). However, the stability of 

SDA can be improved by formulation with appropriate antioxidants (see review in (Jacobsen et 

al., 2008)). One such example is the use of citric acid which provided stability to SDA that was 

similar to that of oleic acid when subjected to 55 and 25 degree heat protocols and then fatty acid 

analysis (Appendix B-2 (Monsanto, 2009)). 

The trend towards increasing use of oil from altered oilseed crops that produce diminished 

linolenic acid (and omega-3 fatty acid) or with increased oleic acids (high oleic sunflower, 

canola, safflower and soybean), is noted by Dubois et al. (Dubois et al., 2007); these changes 

may have consequences for human health (see also Table 9 for omega-3 content in common 

vegetable oils). The need of food manufacturers for products with reduced linolenic acid has 

been met by either new sources of oils (reduced linolenic acid varieties in soybean) or trans 

hydrogenation (which destroys linolenic acid). Although these strategies increase oxidative 

stability and thus shelf-life (desirable properties for merchandising products containing oils),

future trends may not provide for current content of omega-3 fatty acids in human diets, as 

recommended by multiple nutrition authorities (University of Connecticut, 2011). The essential 

fatty acid, linolenic acid, should continue to be available in food products to enhance content of 

healthful DHA and EPA and the longer chain fatty acids, rather than be reduced (Dubois et al., 

2007); replacement with another omega-3 fatty acid such as stearidonic may be a useful dietary 

direction. At present, U.S. National Academy of Sciences (NAS) has not discerned any deficits 

in current U.S. dietary intake. NAS/Institute of Medicine advises an Acceptable Macronutrient 

Distribution Range (AMDR) of omega-3 polyunsaturated fatty acids as 0.6 to 1.2% of dietary

energy, and ratios of omega-6 to omega-3 fatty acids between 5.1 and 10.1 for adults (Otten et 

al., 2006). These AMDRs are based on average consumption values for U.S. consumers, and 

there is no known deficiency of omega-3s in this population.

2.5.3 Worker Safety

Worker hazards in farming are common to all types of agricultural production, and include 

hazards of equipment, exposures to agricultural chemicals, and to plant materials. Production of 

soybean exposes workers to herbicides, and acceptable exposures are regulated by U.S. EPA 

labels. EPA’s Worker Protection Standard (WPS) (40 CFR part 170) was published in 1992 

requiring actions to reduce the risk of pesticide poisonings and injuries among agricultural 

workers and pesticide handlers. The WPS offers protection to more than two and a half million 

agricultural workers who work with pesticides at more than 560,000 workplaces on farms, 

forests, nurseries, and greenhouses. The WPS contains requirements for pesticide safety 

training, notification of pesticide applications, use of personal protective equipment, restricted 

entry intervals following pesticide application, decontamination supplies, and emergency

medical assistance.
51

Grower compliance with all U.S. EPA requirements is required. MON 87769 soybean has no 

added herbicide tolerance, so its cultivation would be similar to that of non-herbicide tolerant 

soybean. None of the agricultural chemicals that would be used with MON 87769 soybean differ 

from those used with other typical commercial soybean varieties. Although an allergenic 

potential of soybean exists, soybean allergy is typically a response to ingestion. Hull 

hypersensitivity following inhalation has been observed, as have asthma reactions of workers to 

soybean dust (Besler et al., 2000). Oils produced by soybean are typical of those produced by 

many other plants and are generally not allergenic (Hefle and Taylor, 1999), but rather are 

required human dietary constituents.

2.6 Animal Feed

Animal feed concerns surrounding GE soybean primarily involve the animal consumption of GE 

soybean products. Soybean meal is a substantial part of animal feed rations in the U.S. In 2009, 

approximately 39 million tons of soybean meal was produced, 27 million tons of which was 

marketed for animal feed, with the largest volumes consumed by poultry (48%), swine (26%), 

and beef (12%) (SoyStats, 2010c, 2010e).

Non-GE soybean varieties, both those developed for conventional use and for use in organic 

production systems, are not routinely required to be evaluated by any regulatory agency in the 

U.S. for feed safety prior to release in the market. 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 soybean must be in compliance with all applicable legal and regulatory 

requirements. GE organisms for feed may undergo a voluntary consultation process with the 

FDA prior to release onto the market.

Although a voluntary process, thus far all applicants who 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.

Monsanto has provided the FDA with information on the identity, function, and characterization 

of the genes, including expression of the gene products in MON 87769 soybean. The submittal 

to the FDA included information on the safety of the SDA and profile of other fatty acids in 

MON 87769 soybean oil, including a dietary risk assessment. Monsanto initiated the 

consultation process with FDA for the commercial distribution of MON 87769 soybean and 

submitted a safety and nutritional assessment of food and feed derived from MON 87769 

soybean to the FDA on March 23, 2009 (BNF No. 00117) (Monsanto, 2010b). FDA is currently 

evaluating the submission.

2.7 Socioeconomic

2.7.1 Domestic Economic Environment

Soybean first entered North America in the 18th century (Hoeft et al., 2000). Sometime during 

the 1930s, soybean was processed industrially in the U.S. for edible oil and protein meal. 
52

Currently, the U.S. produces approximately 38% of the global soybean supply (SoyStats, 2010h). 

In 2009, the U.S. exported 1.3 billion bushels (34.9 million metric tons) of soybean, which 

accounted for 46% of the world's soybean exports (SoyStats, 2010g). In total, the U.S. exported 

$16.5 billion worth of soybean and soybean products globally in 2009 (SoyStats, 2010b). China 

is the largest export market for U.S. soybean with purchases totaling $9.2 billion. Mexico is the 

second largest export market with sales of $1.3 billion in the same year (SoyStats, 2010b). Other 

significant markets include Japan and the EU.

Soybean Production Operating Costs

Managing production costs is a major component to the economics of producing a soybean crop. 

Key cost decisions include the choice of which soybean varieties to plant, the amount of fertilizer 

to apply, and which herbicide program to use. The average operating cost for producing soybean 

in the U.S. in 2006 was $93.41 per acre, with the value of the production less operating cost 

reported to be $161.43 per acre (USDA-ERS, 2006b).

Soybean Products

Soy meal typically contains about 50% protein by dry weight, and is the most important product 

of soybean production. From production and feeding statistics, in 2010 about 67% of the 

domestic-crushed soybean meal was fed to domestic animals, and 28% of the meal was exported 

(most likely for animal feed in the international market) ((SoyStats, 2011b); Table 8, 2009/2010 

(USDA-FAS, 2011)). Of the domestically crushed soybean, 53% of soybean by weight produces 

meal and 19% produces oil (SoyStats, 2011b). Thus, only a small proportion of the soybean 

crop is consumed directly by humans. Human food derives from whole soybean made into 

soymilk (including tofu), or from meal processed into soy flour (meat substitutes) or into isolates 

or concentrates (protein powder) or from processed whole soybeans (soynuts) or from fresh 

soybeans (edamame) (Soyconnection, 2011). The domestic food use of soybean oil is mainly in 

frying oils, salad and cooking oils, and margarines (SoyStats, 2010d). In 2009, these three 

categories represented approximately 85% of the soybean oil market in the U.S., with industrial 

uses consuming the remaining 15% (SoyStats, 2010d; USSEC, 2006). Soybean oil industrial 

uses include plastics, lubricants, coatings, printing inks and adhesives, emulsifiers, surfactants 

(industrial detergents and cleaners as well as solvents), resins, and biodiesel, among others 

(AGRA, 2009; USB, 2010b). Soy-based industrial oil products have many advantages in the 

marketplace, including being inherently biodegradable, having low ecotoxicity, and being 

derived from renewable resources (USSEC, 2006). The extraction of oil from soybeans also 

creates a highly valued solid, soybean meal, which is used for animal food in all sectors (swine, 

beef, poultry, dairy and fish).

Prices for soybean oil typically are among the lowest among those for all vegetable oils. During 

the 10-year period 1996-2006 three months out of 12, only Malay palm oil prices were lower 

than U.S. sourced soybean oil (USDA-FAS, 2008). During the 12-month period OctoberSeptember 2006/2007 corn oil prices were lower than soybean oil prices in only five months 

during the same period (USDA-FAS, 2008) Thus, both low cost and usability have led to 

soybean oil becoming the top choice of food processors and industrial processors for feedstock in 

these industries. 
53

Changes in fatty acid profile may impact food and industrial uses of the soybean oil. Fatty acid 

composition of the soybean oil affects melting point, oxidative stability, and chemical 

functionality, and changes in any of these can impact the market sector of the product (APAG, 

2011). Table 10 illustrates several of the key physical properties of the fatty acid constituents of 

soybean oil.

Table 10. Properties of select fatty acids.

Fatty Acid Fatty Acid 

Lipid 

Number1

Saturated Unsaturated Melting 

Point (oC)

Boiling 

Point (oC)

Palmitic acid C16 X 62.9 167

Stearic acid C18 X 70 361.6

Oleic acid C18:1 X 14 286

Linoleic acid C18:2 X -5 228

Linolenic acid C18-3 X -11 230

Source: (CRC, 2011)

1. As in Table 1, fatty acids are identified based on the number of carbon atoms and the number of double bonds in that fatty 

acid. 

2. oC = degrees Celsius

Palmitic and stearic acids are considered saturated fatty acids, indicating that they do not have 

any carbon double bonds. Oleic acid is a mono-unsaturated fatty acid, containing a single double 

bond, and linoleic and linolenic acids are polyunsaturated fatty acids, containing 2 and 3 double 

bonds, respectively (Institute of Shortening and Edible Oils, 2006). Generally, the longer the 

carbon chains for saturated fatty acids, the higher the melting point, and the more unsaturated, 

the lower the melting point (Berg et al., 2002). 

These fatty acid properties influence the market applications for the oil, and various foods and 

industrial products are formulated to take these properties into consideration. Many of the 

commercial vegetable oils are a carefully blended mix to take advantage of the properties of the 

constituent fatty acids (Cargill, 2011 ). A soy oil with a high content of oleic acid and low 

content of polyunsaturated fatty acids results in an oil with high oxidative stability, a critical 

property for industrial lubricants, as well as achieving the food industry needs for a soy-based oil 

without trans fatty acids (Cahoon, 2003; Soyconnection, 2011).

Soybean Industry Description

Soybean industry comprises two main groups, commodity production businesses and the users of 

soybean products. The commodity production business begins with the providers and 

developers of the traits technology and the seed, retailers that sell seed to growers, the growers 

and their operations. Users of the soybean commodity include those who purchase the soybean 

seed and then crush, process and sell the basic products of seed, oil and meal, to the next set of 

soybean processors or users. The downstream purchasers are animal feed producers, food 
54

producers, oil users in food and industrial sectors, and industrial product manufacturers, such as 

those for biodiesel oil.

Commodity Production Industry

Contracts are typically signed with growers when the specialty seed is purchased, obligating the 

growers to supply harvested seed under given conditions, such as all the soybean from a certain 

number of committed acres, specifying methods of productions and where the seed may be sold, 

and establishing standards for the product when delivered. Contracts between the growers and 

an oil crusher maybe signed, and after oil is crushed, the bulk oil processer companies arrange 

for sale to food or industrial buyers (ADM, 2006).

In the production of soybean seed for commodity or IP use, two industries are relevant. The first 

are businesses that sell seed for planting and applied chemicals, and the second are the buyers of 

soybean grain, the elevators. Both are needed to produce specialty soy products. When a grower 

purchases specialty seeds, he will be required to produce his soybeans for a designated elevator, 

and a contract with the elevator may specify means of production, crop performance and seed 

quality. 

Soybean meal is the most important product deriving from soybean seed and meal is the product 

that drives demand for soybean rather than oil. Oil comprises only 19% by weight of the 

soybean (Tyson et al., 2004). Thus, oil is a minor product of the crushing industry. As noted 

earlier, soybean meal is predominantly fed to animals while a small percentage is used for human 

consumption or industrial uses (see preceding section on “Soybean Products”).

Fatty acid composition of soybean oil is affected by many variables, including genetics of the 

crop, details of the climate including temperature, available water and timing of applied water, 

and probably other facts about the planting site, including soil components (Lee and Herbek, 

2004; Oliva et al., 2006; Primomo et al., 2002). Consequently, a range of values for soybean oil 

can be distinguished in soybean varieties planted in the U.S. See Table 1 for these ranges and a 

typical value found in a general textbook about U.S. oils.

Animal Feed Users

Animal feeds are the major use for soybean meal, consuming about 77% of the total meal 

produced (2007/2008 (USB, 2011a)). Oil from soybean used in animal feed is so limited that it 

is not summarized. The mixed rations for poultry, hogs, cattle, dairy cows, domestic pets, and 

farmed fish often are formulated with soybean meal. In 2008/2009, 10.3 million metric tons of 

meal was used in broiler rations, 9.1 million tons in hog rations and 1.9 million tons in beef 

rations (USB, 2010a). The other animal industries used 7.7 million tons for feeding operations. 

A variety of industries prepares, formulates, manufactures and distributes animal feeds.

Fresh and Processed Food Users

Various industries supply all types of processed and fresh foods deriving from soybean (USB, 

2011c). Grain products from soy include flours, pasta, bread, waffles, and cereal. Oil products 

include margarines, salad and frying oils. Simulated ‘meats’ include soy burgers, hot dogs, 
55

nuggets, and tofu. Vegetable uses include edamame, and soynuts. Simulated ‘milk products’ 

include soymilk beverage, soy cheese, yoghurt, and ice cream.

Oil Users

In the production of oils from oilseed such as soybean, two general industries can be identified 

(O'Brien, 2004). The first is the crusher/refiner whose focus may be oil feedstocks deriving from 

a single source of oilseed, and which processes the oil in a continuous, automated mode. The 

crushing business, which extracts crude vegetable oil and meal, sends the oil to refiners, or may

retain some for industrial and fuel users. The refiners may be separate physically from the 

crushing business and may subject oil to including degumming, refining, bleaching, dewaxing, 

fractionating, interesterifying, hydrogenating, changing the melting points of the oil, blending 

and deodorizing. The refiner may then package the liquid oil, produce margarines, shortening, 

and bulk fats or oils. In 2007, soybean receipts at oil crushing facilities attained to 54.4 million 

tons, with slightly more crushed than originating from receipts (US Census Bureau, 2008). 

Specialty oils when produced at facilities making commodity oils are produced in batches or 

only semi continuously and supply specialized needs of the food processing or other commercial 

products industries. The total value of products from the primary soybean processing industry

were estimated at $18 billion (US Census Bureau, 2009a). 

The second industry comprises the many value-added businesses which may employ starting 

feedstocks from soyseed or other oilseed sources, and which manufacture products from 

commodity oil or a variety of specialized oils. These include food and industrial product 

manufacturers in a wide variety of offerings to businesses, retailers and consumers.

Foods

The properties of oils that are used in foods may vary widely, and these result from the fatty 

acids that are incorporated into constituent triglycerides. The positions of the fatty acids within 

the triglycerides also may help determine these properties. Specific fatty acids have associated 

chemical properties (such as reactivity) and physical properties (such as melting points), as well 

as other functional properties which are taken into account when they are incorporated into 

foods. Oils high in unsaturated fatty acids (5-15%. such as those derived from hydrogenated 

soybean oil, stearin fractions of palm oil, etc.) are useful in making solid fat products such as 

baking shortenings (O'Brien, 2009a), while oils low in saturated fats (and optimally, high in oleic 

acid) are useful for salad oils (O'Brien, 2009b). Trans-esterification may be used to change the 

positions of the fatty acids in the triglyceride, or exchange one for another, all of which can alter 

oil properties. 

When fatty acids are oxidized, flavor is adversely affected, and this is referred to as “reverted” 

oil. Reverted soybean oil has a “beany” or “grassy” flavor (O'Brien, 2004). Oils that are high in 

polyunsaturates are the most susceptible to such oxidation among food oils. Linoleic and 

particularly linolenic in traditional soybean oil are those fatty acids most easily oxidized. 

Hydrogenation of soybean salad oils reduces the content of linolenic acid, a polyunsaturated oil, 

and typically, will reduce it from 9% to 3% (O'Brien, 2004). Reducing the unsaturated linolenic 

acid decreases the possibility that off- flavors will develop. This process also produces “trans” 
56

fatty acids, which have been linked to deleterious consequences for human health, and have 

encouraged the development of other soybean lines with altered fatty acid content.

Industrial (Non-Edible Products) Use

Soybean oil is a feed stock for numerous products used in several domestic industries. Biodiesel 

provides the largest market for soybean oil (see Table 11), with production at 822,000 metric 

tons in 2008/2009 (USB, 2011b). Soybean biodiesel in 2007 had a value of $1.09 billion dollars. 

By comparison, fuel ethanol had a value of $6.6 billion (US Census Bureau, 2009a). Soaps, 

amines, fatty acids and oleo chemicals is the second largest consumer of industrial soybean oil at 

140,000 metric tons (see Table 11) (USB, 2011b). Paints, coatings and inks rank third, with 

118,000 metric tons, and polyols and plastics with 115,000 metric tons. Lubricants and working 

fluids produced a total 26,000 metric tons, and solvents and specialty uses a total of 22,000 tons. 

A total of 15.8 billion pounds of refined soybean oil was processed in the U.S. in 2008 (US 

Census Bureau, 2009b).

Table 11. Industrial soybean oil production 2008/2009.

Product

Soybean oil

(million

metric tons)

Biodiesel 0.822

Soaps, Amines, Fatty Acids & Oleo Chemicals 0.140

Paints, Coatings & Inks 0.115

Polyols & Plastics 0.127

Total Industrial Meal 0.055

Lubricants & Working Fluids 0.026

Solvents & Specialty 0.022

Other Industrial Products 0.010

Total Industrial Whole Bean <0.001

 Source: (USB, 2011b).

2.7.2 Trade Economic Environment

The major producers of soybean are the U.S., Brazil, Argentina, China, and India, which 

accounted for approximately 91% of the global soybean production in 2007 (Soyatech, 2010)

(see Table 12). Soybeans produced in China and India are primarily for domestic use. A 

significant portion of soybean produced in the U.S., Brazil, and Argentina is traded globally in 

the form of soybean harvested seed, soybean meal, or soybean oil (Monsanto, 2010b). Globally, 

the U.S. was the largest soybean seed export country; whereas Argentina led the soybean meal 

and soybean oil export markets in 2007 (Soyatech, 2010).
57

Table 12. World soybean production, 2009.

Country

Production

(million metric tons)

U.S. 80.7

Brazil 57.0

Argentina 32.0

China 15.5

Canada 9.3

India 9.1

Paraguay 3.9

Other 9.3

Total Production 210.9

 Source: (Soyatech, 2008, 2010; SoyStats, 2010h).

2.7.3 Social Environment

Data from the 2007 Census of Agriculture indicated that 279,110 U.S. farms raised soybeans in 

2007, down from 511,000 in 1982 (USDA-ERS, 2010d; USDA-NASS, 2007). Soybean farms 

with sales greater than $50,000 totaled 109, 269 (USDA-NASS, 2007). Although acreage 

planted to soybeans was also lower in 2007 than in 2002 as growers shifted to corn production, 

harvested soybean acreage per farm increased from 114 acres in 1978 to 229 acres in 2007 

(USDA-ERS, 2010d). Although small farms with less than 250 acres accounted for 72% of the 

farms growing soybeans, these farms produced only 26% of the 2007 crop (USDA-ERS, 2010d). 

Irrigation was used on 5.2 million acres of soybean, or 8% of U.S. soybean acreage in 2007 

(USDA-ERS, 2010d). Individual or family farms accounted for 81% of all soybean farms in 

2007 and 69% of soybean production, with the balance identified largely as partnerships and 

small family-held corporations; corporations accounted for less than 1% of soybean farms and 

soybean production (USDA-ERS, 2010d).

Farms which specialized in soybean production have been reported as generally smaller in terms 

of farm size and sales than farms which do not specialize in soybean cultivation (USDA-ERS, 

2006b). Operators of many of the farms which specialize in soybean cultivation have reported 

non-farm incomes. Fewer than half of the growers specializing in soybean cultivation listed 

farming as their primary occupation (36%); whereas, 65% of growers who cultivated a wide 

variety of crops on less specialized soybean farms reported farming as the primary occupation 

(USDA-ERS, 2006b). 

Average acreage of all operated soybean farms is reported as approximately 623 acres; whereas, 

the average acreage of a more specialized soybean farm operator is reported at 390 acres 

(USDA-ERS, 2006b). Nearly 60% of these specialty soybean farmers reported annual income 
58

less than $40,000; whereas, 76% of commodity soybean farmers reported incomes exceeding 

$40,000 per year (USDA-ERS, 2006b). 

Industrial soybean crushers, as represented by membership in the National Oilseed Processors 

Association (which includes 90% of the U.S. oilseed crushers), identify 45 oilseed processing 

plants in 19 states (NOPA, 2011). These may include locations that process oilseed other than 

soybean. For soybean blending and refining, the U.S. Census Bureau (US Census Bureau, 2007)

noted that these operations employ 6,019 people with a total value of products of $19.2 billion. 

Statistics for other parts of the soybean industry are included in summaries for other oil products; 

additional details of soybean businesses from these Census Bureau statistics thus cannot be 

distinguished. To provide perspective about one soybean processor (South Dakota Soybean 

Processors), this business is a cooperative with 2,200 farmer/members. This crushing/refining 

business produces refined and bleached soy oil for industrial buyers, soybean meal and hulls and 

also partly owns an ancillary urethane/resin business The crusher processes 30 million bushels 

of soybean per year and has 83 employees (Hoover's, 2011). 

About 1.3 million metric tons of soybean derived non-food products were produced in 2009 (see 

Table 11). APHIS is not aware of data for the numbers of employees engaged in various 

industrial production sectors using soybean products. However, the largest category of industrial 

products, biodiesel, was estimated in 2009 to include 1700 manufacturing employees and 160 

agricultural workers that were needed to supply the commodity soybean (Cardnoentrix, 2011). 

The same report identified a total of 21,000 jobs as deriving from 2009 biodiesel production. 

Food production involving soybean products has reached $4.5 billion in 2009 (SANA, 

2011download) and total employment in this industry is not readily available.
59

3 ALTERNATIVES

This document analyzes the potential environmental consequences of a determination of 

nonregulated status of MON 87769 soybean. To respond favorably to a petition for nonregulated 

status, APHIS must determine that MON 87769 soybean is unlikely to pose a plant pest risk. 

Based on its PPRA (USDA-APHIS, 2010c), APHIS has concluded that MON 87769 soybean is 

unlikely to pose a plant pest risk. Therefore APHIS must determine that MON 87769 soybean is 

no longer subject to 7 CFR part 340 or the plant pest provisions of the Plant Protection Act. 

Two alternatives are evaluated in this EA: (1) no action and (2) determination of nonregulated 

status of MON 87769 soybean. 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 87769 soybean and 

progeny derived from MON 87769 soybean 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 87769 soybean and measures to ensure physical and 

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

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

unconfined cultivation of MON 87769 soybean. 

This alternative is not the Preferred Alternative because APHIS has concluded through a PPRA

that MON 87769 soybean is unlikely to pose a plant pest risk (USDA-APHIS, 2010c). 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 87769 Soybean is No Longer a 

Regulated Article

Under this alternative, MON 87769 soybean and progeny derived from them would no longer be 

regulated articles under the regulations at 7 CFR part 340. MON 87769 soybean is unlikely to 

pose a plant pest risk (USDA-APHIS, 2010c). Permits issued or notifications acknowledged by 

APHIS would no longer be required for introductions of MON 87769 soybean 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 Plant Protection Act. Because 

the agency has concluded that MON 87769 soybean is unlikely to pose a plant pest risk, a 

determination of nonregulated status of MON 87769 soybean 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 87769 soybean and progeny 

derived from this event if the developer decides to commercialize MON 87769 soybean.
60

3.3 Alternatives Considered But Rejected from Further Consideration

APHIS assembled a list of alternatives that might be considered for MON 87769 soybean. The 

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

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

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

considered for MON 87769 soybean. Based on this evaluation, APHIS rejected several 

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

rejecting each.

3.3.1 Prohibit Any MON 87769 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 87769 soybean, including 

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

not appropriate given that APHIS has concluded that MON 87769 soybean is unlikely to pose a 

plant pest risk (USDA-APHIS, 2010c).

In enacting the Plant Protection Act, Congress found that 

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

under [the Plant Protection Act] shall be based on sound science...§ 402(4).

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

the White House Emerging Technologies Interagency Policy Coordination Committee developed 

broad principles, consistent with Executive Order 13563, to guide the development and 

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

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

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

the extent permitted by law, when regulating emerging technologies: 

“[D]ecisions 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” 

Based on the PPRA (USDA-APHIS 2011) and the scientific data evaluated therein, APHIS 

concluded that MON 87769 soybean is unlikely to pose a plant pest risk. Accordingly, there is 

no basis in science for prohibiting the release of MON 87769 soybean.

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. Because APHIS 

has concluded that MON 87769 soybean is unlikely to pose a plant pest risk (USDA-APHIS, 

2010c), there is no regulatory basis under the plant pest provisions of the Plant Protection Act for 

considering approval of the petition only in part.
61

3.3.3 Isolation Distance between MON 87769 Soybean and Non-GE Soybean Production and 

Geographical Restrictions

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

considered requiring an isolation distance separating MON 87769 soybean from non-GE

soybean production. However, because APHIS has concluded that MON 87769 soybean is 

unlikely to pose a plant pest risk (USDA-APHIS, 2010c), an alternative based on requiring 

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

provisions of the Plant Protection Act and regulations in 7 CFR part 340. 

APHIS also considered geographically restricting the production of MON 87769 soybean based 

on the location of production of non-GE soybean in organic production systems in response to 

public concerns regarding possible gene movement between GE and non-GE plants. However, 

as presented in APHIS’ PPRA for MON 87769 soybean, there are no geographic differences 

associated with any identifiable plant pest risks for MON 87769 soybean (USDA-APHIS, 

2010c). This alternative was rejected and not analyzed in detail because APHIS has concluded 

that MON 87769 soybean 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 APHIS’ statutory authority under the plant pest provisions of the Plant Protection Act and 

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

Framework.

Based on the foregoing, the imposition of isolation distances or geographic restrictions would not 

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

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

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

geographically isolate their non-GE soybean production systems from MON 87769 soybean or to 

use isolation distances and other management practices to minimize gene movement between 

soybean fields. Information to assist growers in making informed management decisions for 

MON 87769 soybean is available from Association of Official Seed Certifying Agencies

(AOSCA, 2010).

3.3.4 Requirement of Testing for MON 87769 Soybean

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. 

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

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

implement and maintain. Additionally, because MON 87769 soybean does not pose a plant pest 

risk (USDA-APHIS, 2010c), the imposition of any type of testing requirements is inconsistent 

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

biotechnology regulatory policies embodied in the Coordinated Framework. Therefore, 

imposing such a requirement for MON 87769 soybean would not meet APHIS’ purpose and 

need to respond appropriately to the petition in accordance with its regulatory authorities.
62

3.4 Comparison of Alternatives

Table 13 presents a summary of the potential impacts associated with selection of either of the 

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

Table 13. Summary of issues of potential impacts and consequences of alternatives.

Attribute/Measure

Alternative A:

No Action

Alternative B:

Determination of 

Nonregulated Status

Meets Purpose and Need and 

Objectives No Yes

Unlikely to pose a plant pest 

risk

Satisfied through use of 

regulated field trials

Satisfied – PPRA (USDAAPHIS, 2010c)

Management Practices

Acreage and Areas of Soybean 

Production Unchanged Unchanged

Seed Production Unchanged Unchanged

Organic Farming Unchanged Unchanged

Specialty Soybean Unchanged Unchanged

Soybean Cultivation Practices Unchanged Unchanged

Physical Environment

Water Resources Unchanged Unchanged

Soil and Land Use Unchanged Unchanged

Air Quality Unchanged Unchanged

Climate Change Unchanged Unchanged

Biological Resources

Gene Movement and 

Weediness Unchanged Unchanged

Animals Unchanged Unchanged

Plants Unchanged Unchanged
63

Attribute/Measure

Alternative A:

No Action

Alternative B:

Determination of 

Nonregulated Status

Microorganisms Unchanged Unchanged

Biological Diversity Unchanged Unchanged

Human and Animal Health

Worker Safety Unchanged Unchanged

Risk to Human Health Unchanged

Unchanged

(potential health benefits)

Risk to Animal Feed Unchanged Unchanged

Socioeconomic 

Domestic Economic 

Environment Unchanged Unchanged

Trade Economic 

Environment Unchanged Unchanged

Other Regulatory Approvals

Other U.S Regulatory 

Approvals

Unchanged for existing 

nonregulated GE 

organisms

FDA consultation pending, 

U.S. EPA tolerance 

exemptions and conditional 

pesticide registrations not 

required.

Compliance with Other Laws

CWA, CAA, EOs Fully compliant Fully compliant

Notes:

1. Unchanged – the current conditions will not change as a result of the selection of this alternative.
64

4 ENVIRONMENTAL CONSEQUENCES

This analysis of potential environmental consequences addresses the potential impact to the 

human environment from the alternatives analyzed in this EA, namely taking no action and a 

determination by the agency that MON 87769 soybean does not pose a plant pest risk and 

therefore should no longer be regulated under 7 CFR 340. Potential environmental impacts from 

the No Action Alternative and the Preferred Alternative for MON 87769 soybean are described 

in detail throughout this section. A cumulative effects analysis is presented for each potentially 

affected environmental concern. Certain aspects of this product and its cultivation would be no 

different between the alternatives: those instances are described below.

4.1 Scope of the Analysis

Potential environmental impacts from the No Action Alternative and the Preferred Alternative 

for MON 87769 soybean are described in detail throughout this section. An impact would be 

any change, positive or negative, from the existing (baseline) conditions of 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 due to increased tillage, and worker safety impacts resulting 

from an increase in herbicide use. 

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 reasonably foreseeable future actions. 

Examples include breeding MON 87769 soybean with other GE events that are no longer subject 

to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant 

Protection Act. If there are no direct or indirect impacts identified for a resource area, then there 

can be no cumulative impacts. Cumulative impacts are discussed in Section 5.

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

potential impacts. Certain aspects of this product and its cultivation may be no different 

between the alternatives; those are described below. 

Although the preferred alternative would allow for new plantings of MON 87769 soybean to 

occur anywhere in the U.S., the scope of analysis of the EA focuses on those areas that are 

expected to support production of MON 87769 soybean. According to the developer 

(Monsanto, 2010c), cultivation of MON 87769 soybean will be limited to the Northern Tier 

states of North and South Dakota, Minnesota, Wisconsin, and Michigan.
65

4.2 Agricultural Production of Soybean

One of APHIS’s missions is to improve American agricultural productivity. Best management 

practices are commonly accepted, practical ways to grow soybean, regardless of whether the 

soybean farmer is using conventional practices with non-GE or GE varieties, or using organic 

practice. These management practices consider crop-specific planting dates, seeding rates, and 

harvest times, among others. Over the years, soybean production has resulted in wellestablished, widely-practiced management practices that are available through local Cooperative 

Extension Service offices and their respective websites. The National Information System for 

the Regional Integrated Pest Management Centers (IPM Centers) publishes crop profiles for 

major crops on a state-by-state basis. These crop profiles provide production guidance for local 

growers, including recommended practices for specific pest control. Crop profiles for many of 

the soybean production states are available at: www.ipmcenters.org/cropprofiles/index.cfm.

Monsanto’s field trials have not demonstrated any agronomic or phenotypic differences between 

MON 87769 soybean and control varieties of soybean (Monsanto, 2010b). Based on the data 

provided by Monsanto for MON 87769 soybean (Monsanto 2010), as well as previous 

experience with other GE soybean varieties that have been widely adopted by growers since their 

introduction in 1996 (USDA-ERS, 2010b), APHIS has concluded that none of the best 

management practices for agricultural production of soybean are expected to change MON 

87769 soybean is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant 

pest provisions of the Plant Protection Act. Consistent with the lack of changes to agronomic 

properties, the potential impacts on agricultural production associated with the No Action and 

Preferred Alternatives are the same.

4.2.1 Acreage and Area of Soybean Production

GE and non-GE soybean varieties are continually under development. In 2009 and 2010, over 

75 million acres in the U.S. were planted in soybean, with over 93% of the soybean expressing 

herbicide tolerance (USDA-ERS, 2010a, 2010b).

No Action Alternative: Acreage and Area of Soybean Production

Based on current acreage trends, commodity soybean production with GE varieties will likely

continue to dominate. Cultivation of GE soybean increased from 17% of the U.S. soybean 

acreage in 1997, to over 93% in 2010. The continued cultivation of soybean and the penetration 

of the soybean market by GE varieties is not expected to change under the No Action 

Alternative. Soybeans are produced commercially in the Northern Tier states (USDA-NASS, 

2011a) and under the No Action Alternative, this range of production is not expected to change.
66

Preferred Alternative: Acreage and Area of Soybean Production

Monsanto has determined that the SDA content of MON 87769 soybean seed would be greatest 

when grown in the most northerly areas of soybean production in the US. Both genotype and 

environment can simultaneously influence ratios of multiple fatty acids in soybean (Hou et al., 

2006). The effects of temperature may be most relevant during the final stages of seed 

maturation (Wilcox and Cavins, 1992). By limiting the proposed production area, Monsanto 

will keep the yield of SDA at the maximal attainable levels (Monsanto, 2010c). 

Production in the Northern Tier states will be encouraged by producing seed only for the lower 

maturity groups (Monsanto, 2010c). Monsanto currently produces Vistive®low linolenic 

specialty soybean lines, and has multiple years of experience with IP production of this variety. 

From a survey of six seed producers selling Vistive®seed, APHIS observed that Monsanto seed 

is available mostly in maturity groups 2-3.6, although one was a 1.5. By this means, Monsanto 

has both focused and restricted the growing area for the Vistive®low linolenic varieties (offered 

through various seed companies). Existing Vistive®varieties are mostly grown in areas where 

soybean is already extensively produced, while MON 87769 soybean will be grown in the more 

northerly parts of these areas. 

A second means seed companies employ to direct production of soybean varieties lines to a

specific region is a contractual one. To produce the soybean crop and receive premium prices, 

growers must sign a contract with an authorized elevator or processor. For the Vistive®line, 

Monsanto lists at least 12 states where commodity seed is purchased or crushed with 127 

elevators and 21 processors in major soybean production areas including Alabama, Iowa, 

Illinois, Indiana, Maryland, Minnesota, Michigan, Missouri, Nebraska, New York, Ohio, 

Pennsylvania, and South Dakota (Monsanto, 2010b). This area is partially coextensive with the 

five-state region proposed by the developer for MON 87769 soybean. If MON 87769 soybean 

seed becomes available, Monsanto would provide growers and the public a list of these elevators 

and crushers, and they will likely be restricted to the five states planned for production of this 

variety. The area proposed for MON 87769 soybean production will correlate with soybean oil 

processors capable of accommodating specialty soybean production. 

Economic considerations constrain growers from marketing their soybeans at too great a distance 

from the specialty soybean crusher or elevators. An Indiana survey determined that 80% of 

growers delivered their soybeans within 25 miles of the growing site. In the northern and central 

parts of the state, at least 50% of soybeans were delivered within 10 miles (Purdue Extension. 

2006). Thus, even if growers purchased the seed for the soybean variety outside of the expected 

optimal range, the high cost of transport would likely deter movement beyond that of authorized 

regional buyers. If Monsanto authorizes only certain elevators to receive the MON 87769 

soybean, then MON 87769 soybean seed sales and delivery of harvested beans can be carefully

constrained by the company. 

Monsanto plans to market MON 87769 soybean as a specialty variety for producing the novel 

constituent SDA by this product (Monsanto, 2010b). Monsanto’s field trials have not 

demonstrated any agronomic or phenotypic differences between MON 87769 soybean and 

control varieties of soybean (Monsanto, 2010b). The changes in fatty acid composition 

expressed in MON 87769 soybean do not require changes in cultivation practices when 
67

compared with other non-GE soybean varieties (Monsanto, 2010b). MON 87769 soybean does 

not confer an increase in cold tolerance, heat resistance, or drought tolerance (these issues are 

discussed again below in the subsection on gene flow) and therefore MON 87769 soybean is not 

anticipated to be cultivated in new regions outside of the current soybean production areas. 

MON 87769 soybean is anticipated to fill a small niche for an omega-3 fatty acid easily 

converted by human metabolism into desirable longer chain fatty acids. MON 87769 soybean is 

not expected to significantly replace plantings of conventional or existing GE varieties where 

those growers seek to cultivate a commodity soybean variety (Monsanto, 2010b). Similar to 

other soybean traits have recently been determined by APHIS to no longer be subject to the plant 

pest provisions of the Plant Protection Act and 7CFR part 340 that modestly alter fatty acid 

ratios, MON 87769 has the potential to lead to increases in specialty soybean acreage. Under the 

Preferred Alternative, a determination of nonregulated status of MON 87769 soybean is not 

expected to increase soybean production, or result in an increase in overall GE soybean acreage 

or cultivation in new regions because this trait is one to be grown for a niche specialty oil 

market, focused on nutritional augmentation. Impacts would be similar to the No Action 

Alternative.

4.2.2 Agronomic Practices

Crop rotation in soybean is conducted to manage weeds, optimize soil nutrition and fertility, 

reduce pathogen loads, and control certain soybean pests (Al-Kaisi et al., 2003; University of 

Illinois, 2006). In crops that have no tolerance to herbicides, such as MON 87769 soybean, 

various types of cultivation and herbicide use are typically employed by soybean growers. 

Besides tillage practices not always used in herbicide tolerant crops, herbicide use would 

generally include burndown, preplant and one or more post plant applications of herbicide (Loux 

et al., 2008). A more diverse pattern of herbicides would also be used in these situations, rather 

than principle use of a single herbicide (glyphosate, glufosinate or ALS) applied preplant or over 

the top, depending on the herbicide tolerant variety planted.

No Action Alternative: Agronomic Practices

Under the No Action Alternative, soybean crop rotation practices and herbicide pesticide use will 

likely remain as it is practiced today by the farming community. Growers will continue to have 

access to existing herbicide-tolerant soybean products that are no longer subject to the regulatory

requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act, as well 

as conventional soybean varieties. Agronomic practices associated with traditional and existing 

non-regulated GE soybean production would not be expected to change under the No Action 

Alternative. As a result, no changes are anticipated from the current agronomic practices 

associated with soybean production, including tillage, cultivation, fertilization, pesticide 

applications, fertilizer applications, or the use of agricultural equipment.

Preferred Alternative: Agronomic Practices

Monsanto has determined that the SDA content of MON 87769 soybean seed would be greatest 

when grown in the most northerly areas of soybean production in the U.S. (Monsanto, 2010c). 

Both genotype and environment can simultaneously influence ratios of multiple fatty acids in 

soybean (Hou et al., 2006). The effects of temperature may be most relevant during the final 
68

stages of seed maturation (Wilcox and Cavins, 1992). By limiting the proposed production area, 

Monsanto will attempt to keep the yield of SDA at the maximal attainable levels.

Monsanto will produce seed only for the lower maturity groups (Monsanto, 2010c) which will 

restrict the potential growing area for the MON 87769 soybean varieties (offered through various 

seed companies). As with other identity preserved soybeans, growers must sign a contract with 

an authorized elevator or processor and which will approve the soybean product quality before 

purchase. Elevators and crushers will be restricted to the five states planned for production of 

this variety. Many of the growers electing to plant MON 87769 soybean and also elevators and 

crushers chosen will likely already have extensive experience in strictly observing standard 

operating procedures (SOPs) to maintain segregation during storage and crush. Otherwise, new 

growers and producers will be provided with SOPs, and asked to agree to conditions of contracts 

so as to channel soybean and oil to purchasers seeking the special fatty acids offered by MON 

87769 soybean.

Monsanto’s studies demonstrate MON 87769 soybean is essentially indistinguishable from other 

soybean varieties in terms of agronomic characteristics and cultivation practices (Monsanto, 

2010b; USDA-APHIS, 2010c). Monsanto did not identify any differences between MON 87769 

soybean and conventional A3525 control soybeans in dormancy, germination potential, disease 

or insect response, seedling vigor, or plant maturity (Monsanto, 2010b; USDA-APHIS, 2010c). 

The similarity in agronomic and phenotypic characteristics suggests that the changes in fatty acid 

profile do not impact the ability of soybean to overwinter or become a volunteer.

A determination of nonregulated status of MON 87769 soybean is not expected to alter the use of 

herbicides currently being used for non-GE soybean production. A preplant burndown herbicide 

would be used, followed by a pre-emergence residual herbicide, with timely post plant herbicide 

applications (Sprague, 2006). The use of glyphosate as a post-emergent weed herbicide in other 

soybean varieties would likely continue to be the pattern for the majority of soybean production.

The tillage procedures if used would be those already employed and include those noted in 

section 2.2.2 (Agronomic Practices). Use of pest control strategies, such as those for insects or 

pathogens would also be unchanged.

If MON 87769 soybean is not stacked with herbicide tolerant traits, control of herbicide tolerant 

corn or soybean volunteers from the previous season would not be different from control of such 

volunteers arising after planting herbicide tolerant crops with typical rotational crops. 

Numerous other registered soybean herbicides are available to eliminate these volunteers (See 

Table IX-4 in Petition (Monsanto, 2010b)).

Monsanto’s field trial and laboratory analyses demonstrated that the agronomic performance of 

MON 87769 soybean was functionally identical to its non-transgenic counterpart (Monsanto, 

2010b). No increases in fertilizers and pesticides were required, nor were any changes in 

cultivation, planting, harvesting, and volunteer control required (Monsanto, 2010b). It is 

expected that similar agronomic practices that are currently used for other commercially 

available GE soybean will also be used by growers of MON 87769 soybean. Overall impacts 

would be similar to the No Action Alternative.
69

4.2.3 Soybean Seed Production

Soybean seed production is managed by seed producers using AOSCA standard methods to 

preclude gene flow between varieties (Bradford, 2006; Sundstrom et al., 2002). Soybean is 

considered a self-pollinated species, exhibiting a high-percentage of self-fertilization (OECD, 

2000). Common practices to preserve varietal identity include: 1) maintaining isolation 

distances to prevent pollen movement from other soybean sources; 2) planting border or barrier 

rows to intercept pollen, employing natural barriers to pollen; and 3) field monitoring for offtypes, other crops, weeds, and disease.

No Action Alternative: Soybean Seed Production

Under the No Action Alternative, current soybean seed production practices are not expected 

to change.

Preferred Alternative: Soybean Seed Production

Monsanto’s field trials have not demonstrated any agronomic or phenotypic differences between 

MON 87769 soybean and control varieties of soybean (Monsanto, 2010b), other than differences 

of fatty acid content. Based on the data provided by Monsanto for MON 87769 soybean

(Monsanto, 2010b), as well as previous experience with other GE soybean varieties that have

been widely adopted by growers since their introduction in 1996 (USDA-ERS, 2010b), APHIS 

has concluded that the availability of MON 87769 soybean would not alter the agronomic 

practices, locations, and the production and quality characteristics of conventional and GE seed 

production (USDA-APHIS, 2010c). The overall impact of a determination of nonregulated 

status of MON 87769 soybean on the availability of conventional and GE seed, and the 

production practices used to grow soybean seeds would be similar to the No Action Alternative. 

Accordingly, there are no differences between the No Action and Preferred Alternatives with 

regard to seed production.

4.2.4 Organic Soybean Production

Organic production plans prepared pursuant to the National Organic Program (NOP) include 

practical methods to prevent unintended presence of genetically engineered materials. Typically, 

organic growers use more than one method to maintain organic certification and prevent 

unwanted material from entering their fields including: isolation of the farm, physical barriers or 

buffer zones between organic production and non-organic production, as well as formal 

communications between neighboring farms (Baier, 2008; Kuepper, 2003; NCAT, 2003). These 

practices follow the same system as that used for the cultivation of certified seed under the 

AOSCA procedures.

APHIS recognizes that producers of non-GE soybean, particularly producers who sell their 

products to markets sensitive to GE traits (e.g., organic or some export markets), can be 

reasonably assumed to be using practices on their farm to protect their crop from unwanted 

substances and maintain their price premium. APHIS will assume that growers of organic 

soybean are already using, or have the ability to use, these common practices as a baseline, 

which APHIS uses for the analyses of the alternatives.
70

Historically, organic soybean production represents a small percentage of total U.S. soybean 

acreage (USDA-ERS, 2010f). In 2005, 122,217 acres of soybean in U.S. were certified organic, 

and in 2008, 125,621 acres were similarly certified (USDA-ERS, 2010f), representing between 

0.17% and 0.22%, respectively, of the soybean production in the U.S. In 2001, 68% of the 

soybean crop was herbicide-tolerant, and by 2010, 93% of the total acreage was herbicidetolerant (USDA-ERS, 2010a, 2010b, 2010f).

No Action Alternative: Organic Soybean Production

Current availability of conventional (both GE and non-GE) soybean varieties, and those soybean 

varieties that are developed for organic production, are expected to remain the same under the 

No Action Alternative. Since 2001, GE varieties of soybean have dominated the market, 

representing 68% of the market in 2001, and 93% of the market in 2010 (USDA-ERS, 2010b). 

Although organic soybeans have a place in the market, the respective share is small, and the 

dedicated acreage appears to be steady. Between 2005 and 2008, the total acreage devoted to 

soybean fluctuated between 72 million and 64 million acres, although organic soybeans ranged 

from 122,000 to 126,000 acres, less than 1% of the total soybean acreage (USDA-ERS, 2010f). 

The market share for organic soybean varieties is not expected to change under the No Action 

Alternative (USDA-ERS, 2010b; USDA-NASS, 2007a, 2010e).

Preferred Alternative: Organic Soybean Production

It is not likely that organic farmers, or other farmers who choose not to plant transgenic varieties 

or sell transgenic seed, will be substantially impacted by APHIS’ determination of nonregulated 

status of MON 87769 soybean. 

GE soybean varieties are currently cultivated on 93% of the U.S. soybean acreage (USDA-ERS, 

2010b), and organic varieties comprise less than 1% of the total soybean acreage (USDA-ERS, 

2010f). In the affected area, only 0.3% of soybean acreage is organic certified (see Affected 

Area analysis). MON 87769 soybean should not present any new or different issues and impacts 

for organic and other specialty soybean producers and consumers.

According to the petition, agronomic trials conducted in 2006 and 2007 at 21 field locations in 

the U.S. demonstrated that MON 87769 soybean in combined site analysis is not significantly

different for plant growth, yield, and reproductive capacity from its nontransgenic counterpart 

(Monsanto, 2010b; USDA-APHIS, 2010c). No differences were observed in pollen diameter, 

and viability (Monsanto, 2010b; USDA-APHIS, 2010c). Consistent with the lack of difference 

in agronomic properties, MON 87769 soybean is not expected to have an increased ability to 

cross pollinate organic soybean varieties.

The practices currently employed to preserve and maintain purity of organic production systems 

would not be required to change to accommodate the production of MON 87769 soybean. 

Common production practices for soybean and the practical methods typically used by 

soybean farmers under organic conditions (NCAT, 2003) can greatly reduce the likelihood of 

accidental gene flow between MON 87769 soybean and non-GE soybean fields. 

MON 87769 soybean will be marketed by Monsanto as a specialty variety to take advantage 

of the high content of SDA (Monsanto, 2010b). Consistent with no required differences in 
71

agronomic practices, and the intention of Monsanto to produce soybean for a specialty 

market, MON 87769 soybean is not expected to displace current organic soybean 

production. 

The acreage devoted to organic soybean is expected to remain small regardless of whether 

new varieties of GE or non-GE soybean varieties, including MON 87769 soybean, become 

available for commercial soybean production. As noted above for the time period of 2005 

to 2008, when the total U.S. acreage dedicated to soybean fluctuated between 72 million and 

64 million acres, the acreage devoted to organic soybeans was relatively stable, reported 

between 122,000 and 126,000 acres (USDA-ERS, 2010f). The percentage of the soybean 

acreage that was organic in the five state region identified as the affected area is only 0.3% 

(see affected area). Significant increases in soybean acreage are not expected, so increased 

GE or conventional soybean acreage adjacent to organic plantings is not expected. 

Consistent with these cultivation trends, a determination of nonregulated status of MON 87769 

soybean is not expected to have a significant impact on organic soybean growers.

4.2.5 Specialty Soybean Production

The soybean industry, supplying both industrial and food products, has numerous products which 

can meet specialized needs. Established methods of IP have maintained these products, and as 

more such specialty products are introduced, will continue to provide them for customers willing 

to pay premiums beyond those prices given to commodity soybean producers.

No Action Alternative: Specialty Soybean Production

Under the No Action Alternative, no changes to soybean production will occur. These products 

will continue to be produced for a variety of niche markets beyond that of commodity soybean.

Preferred Alternative: Specialty Soybean Production

In the event of a determination of nonregulated status, MON 87769 soybean would become an 

additional specialty soybean variety that would be produced and marketed as an IP oil. Monsanto 

plans to exercise product stewardship in a “closed loop” system (Monsanto, 2010b) and would 

supervise the sale and movement of the soybean from growers to designated buyers, and then 

after extraction, continue to oversee the product through a system of required SOPs, contracts 

and agreements to ultimate users. Under a full stewardship plan (see Appendix C of this EA; 

Appendix 1 (Monsanto, 2010b)) buyers and users of the oil would be given full information 

about maintaining product segregation, about necessary procedures and equipment, and 

Monsanto would make themselves available for consulting with entities in the supply chain. To 

meet market needs, additional procedures would be assessed, to be proposed for adoption by the 

principle users of the product in the marketplace. Using a “closed loop” system, a product of 

specified quality is produced by preserving the identity of the product from the seed stock to the 

processed product until it is purchased by the final customer (Smyth and Phillips, 2002b). 

Because the closed loop system is a robust one, APHIS has concluded that the mechanism 

Monsanto has proposed would be capable of implementing effective isolation from other 

specialty oils, as well as commodity oils. APHIS concludes that other soybean specialty crops 

would not be affected by the new SDA producing line MON 87769 soybean.
72

4.3 Physical Environment

4.3.1 Water Resources

The climate in the Heartland south and east of the Great Lakes, and Eastern portions of the Great 

Plains of the U.S. provide sufficient water under normal climatic conditions to produce a 

soybean crop. The adoption of herbicide-tolerant soybean varieties has been a factor in the 

adoption of conservation practices, including conservation tillage. 

Water quality is also preserved in modern soybean production systems. The increase in 

conservation tillage practices has resulted in a reduction of runoff from agricultural lands, 

decreasing non-point source pollution of fertilizer and pesticides. Intensive local monitoring of 

surface water and sub-soils has demonstrated the benefits of no-till soybean in protecting both 

ground and surface water resources (University of Illinois, 2006).

No Action Alternative: Water Resources

Under the No Action Alternative, land acreage and agronomic practices, including irrigation, 

associated with soybean production would not be affected. Herbicide-tolerant soybeans,

cultivated on 93% of the soybean acreage (USDA-ERS, 2010b), have resulted in the adoption of 

increased conservation practices (Monsanto, 2010b). These conservation practices, including 

reduced tillage and precision agriculture, play a significant role in water conservation and 

maintaining water quality by minimizing soil erosion (USDA-NRCS, 2006c). Current 

application rates of glyphosate for weed control are not expected to change.

Preferred Alternative: Water Resources

The acreage on which MON 87769 soybean is grown might revert to full cultivation tillage if the 

new variety was not to be stacked with herbicide tolerance, given that such a high percentage of 

U.S. is currently growing herbicide tolerant soybeans. Conservation tillage, facilitated by

herbicide tolerant crops (see Section 2.2.2, Weed Control), may decrease the likelihood of runoff carrying soil or undesirable pollutants into surface water sources (see Section 2.2.2, Tillage, 

and Section 2.3.1, Water Resources). The consequences of further crossing of MON 87769 

soybean to incorporate other expressed traits is considered in Section 5.3 (Cumulative Impacts: 

Agronomic Practices).

MON 87769 soybean does not change cultivation practices for soybean production, nor would it 

increase the total acres and range of U.S. soybean production areas. A determination of 

nonregulated status of MON 87769 soybean will not change water use in soybean production, as

the MON 87769 soybean is expected to be used as an alternative crop to GE or non-GE soybean 

varieties already in use, offering no additional agronomic benefits to growers.

4.3.2 Soil Quality

No Action Alternative: Soil Quality

Agronomic practices associated with traditional and existing non-regulated GE soybean 

production would not be expected to change under the No Action Alternative. As a result, 
73

no impacts to the soil environment are anticipated from the current agronomic practices 

associated with soybean production, including tillage, cultivation, fertilization, pesticide 

applications, fertilizer applications, and the use of agricultural equipment.

Preferred Alternative: Soil Quality

Monsanto’s field trial and laboratory analyses demonstrated that the agronomic performance of 

MON 87769 soybean was functionally identical to its non-transgenic counterpart (Monsanto, 

2010b). No increases in fertilizers and pesticides were required, nor were any changes in 

cultivation, planting, harvesting, and volunteer control required (Monsanto, 2010b). It is 

expected that similar agronomic practices that are currently used for other commercially 

available GE soybean will also be used by growers of MON 87769 soybean. Therefore, under 

the Preferred Alternative there are no expected impacts to soil quality.

4.3.3 Air Quality

Traditional agricultural practices have the potential to cause negative impacts to air quality. 

Agricultural emission sources include smoke from agricultural burning, tillage, traffic and 

harvest emissions, pesticide drift from spraying, and nitrous oxide emissions from the use of 

nitrogen fertilizer (USDA-NRCS, 2006a). Other GHG emission sources associated with 

agricultural production include equipment emissions (contributing carbon monoxide, nitrogen 

oxides, and reactive organic gases), particulate matter, sulfur oxides, and direct emissions of N2O 

from fertilizer application (US-EPA, 2010a).

Conservation practices, including conservation tillage associated with GE soybean production, 

requires fewer tractor passes across a field (Baker et al., 2005; USDA-NRCS, 2006a). This 

results in a decrease in dust generation and tractor emissions (Baker et al., 2005; USDA-NRCS, 

2006a). Surface residues and untilled organic matter physically hold the soil in place thus 

decreasing wind erosion of soils and pesticide drift in wind-eroded soils (Baker et al., 2005; 

USDA-NRCS, 2006a). Reduced tillage also increases sequestration rates of potential carbon 

emissions from soils (Causarano et al., 2006).

No Action Alternative: Air Quality

Under the No Action Alternative, current impacts to air quality associated with land acreage and 

cultivation practices associated with soybean production would not be affected. Agronomic 

practices associated with conventional soybean production and current GE soybean varieties 

and which contribute to air quality and GHG emissions, including tillage, cultivation, 

irrigation, pesticide application, fertilizer applications and use of agriculture equipment, 

would not be expected to change.

Preferred Alternative: Air Quality

A determination of non-regulated status of MON 87769 soybean will not change the cultivation 

or agronomic practices, or agricultural land acreage associated with growing soybean, and is 

expected to have the same effect on air quality as the No Action Alternative.
74

4.3.4 Climate Change

No Action Alternative: Climate Change

Under the No Action Alternative, current impacts on climate change associated with soybean 

production would not be affected. Agronomic practices associated with soybean production 

such as tillage, cultivation, irrigation, pesticide application, fertilizer applications and use of 

agriculture equipment would continue on soybeans grown throughout the region.

Preferred Alternative: Climate Change

There is unlikely to be a measurable change in an agricultural practice that might affect climate 

change in soybean fields where MON 87769 soybean would be grown. Agronomic practices 

associated with soybean production such as tillage, cultivation, irrigation, pesticide application, 

fertilizer applications and use of agriculture equipment would continue on soybeans grown 

throughout the region. Therefore, there would be no change in agricultural activities that might 

contribute to climate change.

A determination of non-regulated status of MON 87769 soybean is expected to have the same 

effect on climate change as the No Action Alternative.

4.4 Biological Resources

4.4.1 Animal Communities

Soybean production systems in agriculture are host to many animal species. Mammals and birds 

may use soybean fields and the surrounding vegetation for food and habitat throughout the year. 

Invertebrates can feed on soybean plants or prey upon other insects living on soybean plants as 

well as in the vegetation surrounding soybean fields. The cumulative effects analysis for the 

potential effects of the production of MON 87769 soybean on plants and animals is found in 

Sections 5.11 (Animals), 5.12 (Plants), and 5.15 (Biodiversity).

No Action Alternative: Animal Communities

Under the No Action Alternative, conventional and GE soybean production would continue 

while MON 87769 soybean remains a regulated article. Potential impacts of GE and non-GE 

soybean production practices on non-target animals would be unchanged.

Preferred Alternative: Animal Communities

Monsanto data indicate that the agronomic practices used to produce MON 87769 soybean will 

be the same as those used to produce other conventionally grown GE and non-GE soybean. MON 

87769 soybean production is not expected to change land acreage or any cultivation practices for 

soybean production. 

MON 87769 soybean provides a modified fatty acid profile based on the introduction of Primula 

juliae Δ6 desaturase (Pj.D6D) and Neurospora crassa Δ15 desaturase (Nc.Fad3). Changes in 

fatty acid composition resulting from the expression of these genes are not expected to cause 
75

impacts to animals consuming the soybean. MON 87769 soybean contains two principle new 

fatty acids, stearidonic (26% of total fatty acids) and gamma-linolenic (7%). MON 87769 

soybean contains modestly reduced oleic acid and substantially reduced linoleic fatty acids 

compared to the typical range of fatty acids found in commodity soybean oil (Table E-16 

(Monsanto, 2010b)). MON 87769 soybean has a fatty acid profile that is comparable to 

commercial high oleic vegetable oils (e.g., high oleic canola, high oleic safflower, high oleic 

sunflower), traditional oils such as olive oil that has a long-history of consumption in the diet, 

and canola oil that obtained FDA GRAS (Generally Recognized as Safe) status. Table 14 

presents a comparison of fatty acid profiles of several plant sources of vegetable oil, including 

conventional soybean and MON 87769 soybean. 

Table 14. Comparison of fatty acid profiles for oil derived from MON 87769 soybean with 

several other plant sources 

Vegetable Oil

Type

% 

Saturated 

Fat1

% Oleic 

Acid1

(18:1) 2

% Linoleic 

Acid1

(18:2)

% 

Linolenic 

Acid1,4

(18:3)

% 

Stearidonic 

Acid3 

(18:4)

% PUFAs1

Canola 6 57 26 10 0 36

MON 87769 

Soybean

13 16 26 11 26 67

MON 87705 

Soybean

6 76 10 7 0 17

Conventional 

Soybean5

15 23 53 8 0 60

Olive 13 78 7 1 0 8

Palm 50 38 11 1 0 12

Coconut 92 6 2 0 0 2

Source: Table P-3 and Table VII-2 (Monsanto, 2010b).

Notes:

1. Percent fatty acid presented as a percent (%) of total fatty acids.

2. Ratios presented within parenthesis represent the lipid numbers for the subject fatty acid, one of the more common 

nomenclature systems. The first number, e.g., 18, indicates the number of carbon atoms in the fatty acid, and the 

second number, e.g., 1, indicates the number of double bonds in the fatty acid. A fatty acid is considered saturated 

when there are no double bonds in the carbon chain, hence the 18:3 linoleic acid would be considered a polyunsaturated 

fatty acid, presenting three double bonds across the 18 carbons.

3. From Table VII-1 (Monsanto, 2010b); (Monsanto, 2010c).

4. Alpha linolenic totals; add 7% additional for gamma linolenic in MON 87769 soybean

5. A3525, the variety originally transformed, a conventional variety. 

Monsanto statistically analyzed 42 seed components and seven in forage. The samples were 

collected at five sites and included a combined site analysis. Some 28 differences between the 

MON 87795 and control observations for constituents were significantly different, but except for 

linoleic acid, were either within the published variability of existing commercial cultivars, or 

were actually within a 99% tolerance limit based on existing commercial cultivar values. 

Linoleic acid was expected to be different, because it is a substrate for the desaturases introduced 

into the soybean to make SDA. In seed, statistically significant differences were found in 19 

nutrients other than fatty acids including amino acids in combined site analyses, and these were 

all of less than 10%, but were not outside the 99% tolerance level for commercial soybean 

properties. Differences in fatty acids (including linoleic acid) in combined-site analyses between 

MON 87769 soybean and a conventional control included six fatty acids of the eight analyzed. 
76

Except for linoleic acid, a substrate for the introduced desaturases, all of these differences were 

within the 99% tolerance level for commercial content of these fatty acids (Monsanto, 2010).

Animals are known to forage on soybean foliage and seed. With the exception of the 

introduction of the desaturase genes, genes to change fatty acid composition, no phenotypic or 

morphological differences have been identified between MON 87769 soybean and conventional 

soybeans. Composition of MON 87769 soybean forage was compared to a conventional control 

(the host variety used in the transformed variety) and analyzed for fiber and no combined site 

differences were found, although one site of the five showed an increase. For proximates, fat 

was slightly decreased at one site of five; neither difference was outside the commercial 

tolerance range. No observable adverse effect of feeding up to 4 g of SDA oil/kg body weight 

per day was determined in a 90 day, one-generation reproductive rat toxicity study (Hammond et 

al., 2008). The two new proteins in MON 87769 are homologous to many other desaturases 

found in food or feed, have no similarity to known toxins, are present at very low quantities in 

foods, and are readily digestible in simulated gastric and digestive fluids (Monsanto, 2010b). 

The potential risks to animals from the consumption of MON 87769 soybean with modified fatty 

acid composition will be evaluated by the FDA (Monsanto, 2010b). Soybean meal is the most 

common supplemental protein source in U.S. livestock and poultry rations due to its nutrient 

composition, availability, and price. Although MON 87769 soybean is intended to be cultivated 

as a specialty soybean to take advantage of the SDA production, the soybean meal remaining 

after the extraction of the soybean oil may become a constituent of livestock or poultry food 

supplements. Monsanto completed a feeding study and a one generation reproduction study on 

rats using oil derived from the MON 87769 soybeans and fed in substantial quantity. No adverse 

treatment related effects were determined from either study (Hammond et al., 2008). Monsanto is 

completing a consultation with FDA on the possible impacts on animals using feed containing 

MON 87769. The analysis will compare the composition of MON 87769 soybean with the 

conventional non-transgenic soybean variety A3525 (also the original line used for the 

transformation), and evaluate the potential impacts to animal diets from the reduced intake of 

linoleic acid. Although the soybean meal derived from MON 87769 soybean would have 

reduced levels of linoleic acid, the animal’s requirements for linoleic acid could be met by other 

ingredients in animal feed. 

One important use of MON 87769 will be to enhance the omega-3 fatty acids in animal tissues, 

either with stearidonic acid itself, or with the elaborated fatty acids, DHA and EPA. Broiler 

chickens were fed with soy oil from the MON 87769 SDA line, from isogenic lines and with fish 

oil. Feeding MON 87769 oil increased the incorporation of three desirable fatty acids over the 

isoline fed animals, and the treatments did not change the intake, weight gain or feed conversion 

efficiency (Rymer et al., 2011). Similarly, MON 87769 SDA-containing oil when fed to sea bass 

can increase the DHA concentrations in fish muscle (Bharadwaj (Bharadwaj et al., 2010) et al., 

2010). When introduced into the abomasum of dairy cows, MON 87769 oil can increase omega3 fatty acids five fold over control with no impact on milk production or on milk fat yield 

(Bernal-Santos (Bernal-Santos et al., 2010).

Based on the above information, APHIS concludes that a determination of nonregulated status of 

MON 87769 soybean is not expected to have adverse effects on non-target animals.
77

4.4.2 Plant Communities

The landscape surrounding a soybean field may be bordered by other soybean (or any other 

crop) fields or may also be surrounded by woodland, rangelands, and/or pasture/grassland 

areas. These plant communities may be natural or managed plant habitats for the control of 

soil and wind erosion and/or serve as wildlife habitats.

In this context, weeds are those plants which, when growing in the soybean field, compete with 

the soybean for space, water, nutrients and sunlight, and may thus include native species. The 

types of weeds in and around a soybean field will vary depending on the geographic region 

where the soybean is grown, as is apparent from control recommendations in various states 

(Aref and Pike, 1998; Byrd et al., 2003; Duke and Powles, 2009; Loux et al., 2009).

No Action Alternative: Plant Communities

Plant species that typically inhabit soybean production systems will continue to be managed 

through the use of mechanical, cultural, and chemical control methods, including the use of 

glyphosate in those varieties already marketed as glyphosate-tolerant. No changes to 

cultivation practices are expected in the No Action Alternative.

Preferred Alternative: Plant Communities

In the event of a determination of nonregulated status of MON 87769 soybean, the risks to wild 

plants and agricultural productivity from weedy soybean populations are low; volunteer soybean 

populations are easily managed and there are no feral or weedy relatives. Agronomic studies 

conducted by Monsanto tested the hypothesis that the weediness potential of MON 87769 

soybean is unchanged with respect to conventional soybean (Monsanto, 2010b). No differences 

were detected between MON 87769 soybean and nontransgenic soybean in growth, 

reproduction, or interactions with pests and diseases, other than the intended effect, which is 

production of SDA. Volunteer soybean is normally not a concern. Soybean is not winter hardy, 

and existing mechanical and chemical methods are available to manage the occasional volunteer 

soybean in cultivation areas (Carpenter et al., 2002; OECD, 2000). Several post-emergent 

herbicides are also widely used to control the presence of volunteer soybeans in subsequent 

rotational crops (See Table IX-4 (Monsanto, 2010b; Zollinger, 2010)). Based on these biological 

limitations, as well as readily available control practices, a determination of nonregulated status 

of MON 87769 soybean is not likely to result in increased weediness. Overall impacts would be 

similar to the No Action Alternative.

4.4.3 Gene Flow and Weediness

Two forms of gene flow are evaluated: Vertical gene flow and horizontal gene flow. Vertical 

gene flow, or hybridization and associated introgression, is the movement of genes to sexually

compatible relatives (Ellstrand, 2003; Quist, 2010). The soybean is considered self-pollinating, 

and has no wild relatives in the U.S. (Monsanto, 2010b; OECD, 2000). Although some crosspollination can occur, AOSCA identity protection practices have been found adequate to protect 

against such gene flow (Monsanto, 2010b; OECD, 2000; USDA-APHIS, 2010c). The only 

relatives of soybean are other varieties currently cultivated. In assessing the risk of gene 

introgression from MON 87769 soybean to its sexually compatible relatives, APHIS considered 
78

two primary issues: 1) the potential for gene flow and introgression to soybean relatives; and 2) 

the potential impact of introgression. Vertical gene flow is discussed below in the analysis of the 

Preferred Alternative.

Horizontal gene flow represents the stable movement of genes from one organism to another 

without reproduction or human intervention (Keese, 2008; Quist, 2010). There is no evidence of 

naturally occurring transgene movement from transgenic crops to sexually incompatible species

(Stewart, 2008). Horizontal gene transfer and consequent expression of DNA from one plant to 

another sexually incompatible plant or other phyla (e.g., species of bacteria) is unlikely to occur

(Keese, 2008). This event would require physical relocation of the functional genetic sequences 

from the transgenic plant to the new location, including not only the genes which code for the 

production of specific proteins, but also those portions of the genome which regulate the activity

of those genes (Keese, 2008; Stewart, 2008). There are no known naturally occurring vectors 

(such as plasmids, phages, or transposable elements) that could be responsible for inter-domain 

gene transfer, and there is little evidence that eukaryotic cells are naturally capable of stably 

incorporating genes from the environment into their genome (Brown, 2003). Although viruses 

do move genetic material, all viruses that infect higher plants have small RNA or DNA genomes, 

usually with fewer than 20 encoded proteins (Keese, 2008). These viruses are, therefore, 

constrained as to the type and size of novel genetic material which can be acquired by horizontal 

gene transfer (Stewart, 2008). The development of herbicide resistance, particularly that found

in crop fields treated with glyphosate, is thus not a result of gene transfer but is the result of 

selective pressures associated with herbicide use. This issue is discussed in the subsection on 

impacts to plant communities.

Two bacteria species commonly associated with plants, Agrobacterium and Rhizobium, have 

been evaluated to determine the probability of horizontal gene transfer between the bacterium 

and their host plants. Agrobacterium moves its genes from its bacterial plasmid to the plant 

causing the plant to produce the gall; Rhizobium aids in nitrogen fixation in legume nodules

(Stewart, 2008). The genomes of both bacteria have been sequenced, and the sequenced genes 

evaluated in search of exogenous genes (Kaneko et al., 2000; Kaneko et al., 2002; Wood et al., 

2001). Despite what would appear to be millennia of symbiotic relationships between these 

bacteria and their host plants, there is no evidence that these organisms contain genes derived 

from plants (USDA-APHIS, 2010c). In cases where review of sequence data implied that 

horizontal gene transfer occurred, these events are inferred to occur on an evolutionary time 

scale of millions of years (Brown, 2003; Koonin et al., 2001). Transgene DNA promoters and 

coding sequences are optimized for plant expression, not bacterial expression (USDA-APHIS, 

2010d). Horizontal gene flow, resulting in the relocation of entire transgenes including the 

regulatory portions of the DNA (those parts of the DNA which code for the production of the 

specific proteins in that relocated transgene) has never been shown to occur in nature (Clarke, 

2007; Stewart, 2008). Thus, even if horizontal gene transfer occurred, proteins associated with 

these transgenes are not likely to be produced in the new host organism (Stewart, 2008; USDAAPHIS, 2010c). Based on this information, APHIS considers the horizontal gene flow from 

MON 87769 soybean or other cultivated GE soybean varieties to unrelated species to be 

unlikely.
79

No Action Alternative: Gene Flow and Weediness

Under the No Action Alternative, conventional and GE transgenic soybean production will 

continue to be grown commercially, while MON 87769 soybean will remain a regulated article. 

Soybean cultivation practices are expected to remain the same. Gene flow from current 

commercially available GE cultivars to non-GE soybean cultivars is expected to remain 

unchanged from the current conditions.

Preferred Alternative: Gene Flow and Weediness

APHIS evaluated the potential for gene introgression to occur from MON 87769 soybean to 

sexually compatible varieties and considered the possibility that such introgression would result 

in increased weediness. Monsanto’s data found no significant difference in pollen morphology

and viability from field grown MON 87769 soybean plants and other soybean varieties. The 

soybean is not identified as a weed in the U.S. (USDA-APHIS, 2010c). Soybeans are not frost 

tolerant, do not survive freezing temperatures, and do not reproduce vegetatively (OECD, 2000; 

USDA-APHIS, 2010c). 

Some research suggests that fatty acid composition may influence cold tolerance and 

survivability. Kodama (Kodama, 1994) and Kodama et al. (Kodama et al., 1995) found that 

increases in levels of certain fatty acids, particularly hexadecatrienoic and linolenic acids, results 

in an increase in cold tolerance. In MON 87769 soybean, the levels of linolenic acid are within 

the lower end of the commercial range of fatty acid composition when compared with other 

varieties (Monsanto, 2010b). Changes in oleic acid or linoleic acid composition and reductions 

in saturated fatty acids have not been linked to increased cold tolerance. The changes in fatty 

acid composition MON 87769 soybean are not expected to enhance cold tolerance (USDAAPHIS, 2010c).

In its PPRA, APHIS assessed the weediness potential of MON 87769 soybean based on the 

introduced Primula juliae delta-6 desaturase (Pj.D6D) and the Neurospora crassa delta-15 

desaturase (Nc.Fad3) genes controlling fatty acid composition (USDA-APHIS, 2010c). The 

changes introduced in the MON 87769 soybean were deemed to not present a weediness risk

(USDA-APHIS, 2010c). 

The change in composition of fatty acid in MON 987769 Soybean is due to the activity of the 

endogenous Pj.D6D and the Nc.Fad3 genes in the soybean. These two genes pose no novel risks 

from a plant pest perspective (USDA-APHIS, 2010c). The action of these two genes in MON 

87769 soybean is not anticipated to give rise to an enhanced weediness or gene flow.

In its petition, Monsanto presented information on phenotypic and agronomic characteristics 

collected from field studies (Monsanto, 2010b). These data included information on seed 

dormancy, germination, emergence, seedling vigor, plant height, lodging, days to maturity, 

shattering, seed weight, yields, disease incidence, and insect damage, among others (Monsanto, 

2010b). 
80

APHIS has assessed those parameters including some of those noted above to evaluate the 

weediness potential of MON 87769 soybean. Monsanto found no biologically significant 

differences between MON 87769 soybean and the original commercial variety that was 

transformed for seed dormancy, germination, early stand count, seedling vigor, days to 50% 

flowering, lodging, pod shattering, and final stand count. All values were within the 

recommended standards for certified soybean seed (AOSCA, 2009).

To determine whether the variety could be more likely to increase gene flow, Monsanto studied 

pollen viability and morphology. No statistically significant differences were detected between 

MON 87769 soybean, the original modified line, and other controls for percent viable pollen or 

pollen grain diameter (Monsanto, 2010b). No differences in pollen morphology were observed. 

Thus, differences in gene flow to other soybean are unlikely. 

Results from the phenotypic and agronomic assessments indicate that MON 87769 soybean does 

not possess characteristics that would confer a plant pest risk compared with conventional 

soybean (USDA-APHIS, 2010c). These data indicate that the engineered plant is not different in 

any fitness characteristics from its parent that are likely to cause the MON 87769 soybean to 

become weedy or invasive (USDA-APHIS, 2010c). 

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

status of MON 87769 soybean will not impact other soybean varieties through gene flow or 

introgression, nor would it present a greater risk of weediness or invasive characteristics

(USDA-APHIS, 2010c). MON 87769 soybean is expected to have the same effect on gene 

movement as the No Action Alternative.

4.4.4 Microorganisms

Microorganisms in soil are important components that sustain and provide the dynamic aspects 

of soil associated with critical ecological processes. Nutrient cycling, establishing soil structure 

contributing to plant growth, metabolism of deleterious components are all dependent on the 

microbial constituents. The health and growth of these microbes may be influenced by many 

processes and conditions.

No Action Alternative: Microorganisms

There would be no changes to current cultivation practices under the No Action Alternative. 

Microbes in the field would continue to be exposed to glyphosate and other herbicides.

Preferred Alternative: Microorganisms

Monsanto conducted field observations to assess potential agronomic differences between MON 

87769 soybean and conventional soybean (variety A3525, used for the transformation) over two 

years and at a total of 21 locations (Monsanto, 2010b). The disease analysis included 

observations of a wide range of bacterial and fungal pathogens, nematodes, and plant viruses 

(Table I-4, I-5 (Monsanto, 2010b)). No significant incidence of disease damage was noted 

between MON 87769 soybean and the comparison variety (Monsanto, 2010b). The lack of 

difference indicates that the expression of stearidonic and gamma linolenic acid and modified 
81

fatty acid content by MON 87769 soybean does not change soybean interactions with 

microorganisms in the field.

Monsanto also evaluated the potential impacts of these changes on the symbiotic relationship of 

soybean with the nitrogen-fixing root nodule bacteria Bradyrhizobium japonicum (Monsanto, 

2010b). In these studies, MON 87769 soybean was compared with the original transformed 

conventional line, and six conventional soybean varieties as well as the negative isoline for 

MON 87769 soybean (Monsanto, 2010b). No significant differences were detected between 

MON 87769 soybean and any of the comparison varieties for nodule number, biomass of 

nodules, shoot total nitrogen (percent and mass), or shoot and root material (Monsanto, 2010b). 

These results indicate that the expression of the modified fatty acid composition does not impact 

the biology of root nodules formation by the symbiotic bacteria.

Consistent with these test results, the impacts of a determination of nonregulated status of MON 

87769 soybean on microorganisms is the same as the No Action Alternative.

4.4.5 Biodiversity

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, including selection and use of insecticides and herbicides; 

and 4) extent of isolation of the agroecosystem from natural vegetation (Altieri, 1999; Palmer et 

al., 2010). The reintroduction of woodlots, fencerows, hedgerows, wetlands, etc., has been used 

to enhance biodiversity in the agroecosystem landscape. Some enhancement strategies include 

intercropping (the planting of two or more crops simultaneously to occupy the same field), 

agroforestry, crop rotations, cover crops, no-tillage, composting, green manuring (growing a crop 

specifically for the purpose of incorporating it into the soil in order to provide nutrients and 

organic matter), addition of organic matter (compost, green manure, animal manure, etc.), 

adoption of integrated pest management techniques, and the use of hedgerows and windbreaks 

(Altieri, 1999; Palmer et al., 2010). The adoption of GE crops, with the concomitant reduction in 

insecticide use and enhanced soil conservation practices, has also contributed to the increase in 

biodiversity of soil microorganisms, beneficial organisms, and plants (Dively and Rose, 2003; 

Naranjo, 2009; Palmer et al., 2010; Sanvido et al., 2006).

No Action Alternative: Biodiversity

Under the No Action Alternative, MON 87769 soybean would continue to be a regulated article. 

Growers and other parties who are involved in production, handling, processing, or consumption 

of soybean would continue to have access to GE soybean varieties that are no longer subject to 

the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection 

Act, herbicide-tolerant soybean varieties, and conventional soybean varieties. The implications 

of agronomic practices associated with soybean production whether traditional or GE varieties 

with the attendant effects on biodiversity would not change.

Preferred Alternative: Biodiversity

Although soybean fields are cultivated as monocultures to optimize soybean yield, the landscape 

adjacent a soybean field may harbor a wide variety of plants. Broad spectrum herbicide 
82

application has the potential to impact off-site plant communities. The herbicide choices used 

for cultivation of MON 87769 soybean will not be different from those used by growers for weed 

control on other non-herbicide tolerant varieties, and acreage is not expected to exceed 100,000 

acres in five years (Monsanto, 2010b). Consequently, production MON 87769 soybean is not 

expected to result in an increase in the application of herbicides or frequency of application over 

other existing non GE soybean varieties. A determination of nonregulated status of MON 

87769 soybean is not expected to change the cultivation or agronomic practices, or agricultural 

land acreage associated with growing soybean. 

The stearidonic and gamma linolenic acid expressed in MON 87769 soybean, which are also 

expressed in some other plants, fish, and algae, would have no effect on animals that might feed 

on soybean, because the novel oils have been shown to have no harmful consequences by 

feeding (see FDA acceptance of GRAS status of oils from this variety). Monsanto has shown 

that expression of the two new proteins in MON 87769 soybean are homologous to many other 

desaturases found in food or feed, have no similarity to known toxins, are present at very low 

quantities in foods, and are readily digestible in simulated gastric and digestive fluids (Monsanto, 

2010b). Thus, no potential for allergic response has been demonstrated by consuming the meal 

deriving from the soybean. Therefore, a determination of nonregulated status of MON 87769 

soybean is highly unlikely to have any direct toxic effects on non-target organisms and is likely

to be neutral or beneficial to animal and plant biodiversity. 

The abundance of diverse beneficial insects was assessed over two years in four states (Tables I8 and I-10 (Monsanto, 2010b)). No consistent differences were noted in the populations of these 

insects over three collections spanning reproductive development of the soybean. The insects 

surveyed included Carabid and ladybird beetles, parasitic wasps, predatory plant bugs and

spiders. No differences in insect diversity would be expected under the Preferred Alternative 

compared to the No Action Alternative.

The cultivation of MON 87769 soybean would not change the use of insecticides to manage the 

invertebrate pests of soybean since there is no difference in insect damage or populations of pest 

insects in MON 87769 soybean and conventional control soybean (Monsanto, 2010b). 

Populations of pest insects were assessed in four states comparing MON 87769 soybean and 

conventional line A3235, the parental line during two growing seasons (Monsanto, 2010). 

Aphids, beanleaf beetles, leaf hoppers and three moth pests among others were assessed over 

three collection periods during the reproductive phase of plant growth. No consistent differences 

were found in populations of insects in these locations and years. Practices currently employed 

for the management of conventional and other GE soybean would likely continue for this crop. 

In this regard, a determination of nonregulated status of MON 87769 soybean would have the 

same impacts on biodiversity as the No Action Alternative.

4.5 Human Health

4.5.1 No Action Alternative
83

Public Health

Under the No Action Alternative, MON 87769 soybean would continue as a regulated article. 

Human exposure to existing traditional and GE soybean would not change under this alternative. 

Growers and consumers exposure to this product would be limited to those individuals involved 

in the cultivation of MON 87769 soybean under regulated conditions.

Worker Safety

During agricultural production of soybean, agricultural workers and pesticide applicators may 

be exposed to a variety of EPA registered pesticides (see, e.g., 

http://www.cdc.gov/niosh/topics/pesticides/). Such chemicals would be expected to include 

those products currently used for insect pest and plant pest management in both GE and non-GE 

soybean cultivation. Worker safety is taken into consideration when a U.S. EPA pesticide label 

is developed during the registration process. When use is consistent with the label, pesticides 

present minimal risk to the worker. Industrial production of soybean oil has standard hazards 

common to many manufacturing processes. No changes to current worker safety are anticipated 

under the No Action Alternative.

4.5.2 Preferred Alternative: Human Health

Public Health

APHIS considers the FDA regulatory assessment in making its determination of the 

potential impacts of a determination of nonregulated status of the new agricultural product. 

Monsanto has submitted the data needed for a full consultation with FDA and has 

demonstrated the safety of the new proteins. Previous to the submitted FDA new protein 

consultation, Monsanto submitted a GRAS Notice for SDA soybean oil (No. GRN 000283) to 

FDA on February 25, 2009 (US-FDA, 2009b). FDA issued a response letter on September 4, 

2009, indicating the agency has no further questions about the characteristics of the oil, and 

safety of its use in foods (US-FDA, 2009a). 

Monsanto’s intention in developing MON 87769 soybean is to provide a plant source of omega-3 

fatty acid that can efficiently be converted to the long chain polyunsaturated fatty acids, DHA 

and EPA, which are important in prevention or improvement of human health conditions. Oil 

derived from MON 87769 soybean would be used to enrich a wide variety of foods, including 

processed foods, margarine, salad dressings, and other selected food categories.

APHIS has considered the human health impacts associated with the new fatty acids expressed in 

MON 87769 soybean deriving from activity of the two desaturases, PjD6D and Nc.Fad3. The 

possible impacts of ingestion of the proteins were considered, as were the new fatty acids. 

Neither desaturase protein formed by the introduced sequences have amino acid segments that 

are structural or immunologically relevant to human allergens, and both are easily degraded by

simulated gastric and intestinal fluids (Monsanto, 2010b). The two proteins were purified from 

immature soybean seed, and tested for adverse effects on mice (Monsanto, 2010b). A ‘No 

Observed Effect Level’ (NOEL) was found for mouse ingestion up to 37.3 mg/kg body weight, 

which is 29,000 and 47,000 times the concentration expected in human diet when containing oils 

from MON 87769 soybean.
84

Monsanto presents data comparing the fatty acid and other nutritional element concentrations 

with the reported ranges for conventional soybean against commercial tolerance ranges (see 

summary Table 15, below). MON 87769 soybean fatty acids are compared with conventional 

soybean and commercial ranges of these fatty acids. In addition to evaluating the targeted fatty 

acid composition, Monsanto evaluated non-fatty acid nutrients, anti-nutrients, proximate and 

fiber levels, consistent with the compositional guidance provided by the OECD (OECD, 2001). 

Table 15: Comparison of percentage fatty acid in MON 87769 soybean with conventional 

soybean control (A3525) and commercial range.

Fatty Acid

Total Percent (%)

MON 87769 

Soybean

Mean

Conventional 

Soybean (A3525)

Mean

Commercial 

Soybean Range

16:0 palmitic 12.1 11.8 9.9-12.3

18:0 stearic 4.2 4.2 3.7- 4.9

18:1 oleic 15.2 19.2 16.7 - 23.2

18:2 linoleic 22.8 54.9 53.4 - 57.4

18:3 alpha-linolenic 11.2 9.2 7.0 – 10.6

18:3 gamma-linolenic 7.1 N/A N/A

18:4 stearidonic 26.1 N/A N/A

Source: Table E-12 and Table VII-1 (for percentage of new fatty acids) (Monsanto, 2010b).

From the summary Table 14, total saturated fat (as measured by palmitic and stearic acid 

percentages) in MON 87769 soybean was similar to that of conventional soybean and olive oil. 

The mean level of oleic acid decreased 4% in MON 87769 soybean compared to the 

conventional soybean variety (Table 15). Linoleic acid decreased from 54.9% in conventional 

soybean to 22.8% in MON 87769 soybean, and this is reflected in the appearance of stearidonic 

in MON 87769 soybean at 26.1%. There was a 2% increase in alpha-linolenic acid in MON 

87769 soybean when compared to the conventional variety and the appearance of gamma 

linolenic acid of 7%. Overall, the total polyunsaturated fatty acids of MON 87769 soybean and 

conventional soybean are similar. 

SDA commonly occurs within the environment, and is found in 17 plant families and over 200 

species at more than 1% of fatty acid content (p. 8 (Monsanto, 2010b)) and gamma-linolenic acid 

is found in at least 13 species (Table X-1 (Monsanto, 2010b)). Many plant species are cultivated 

as a source of these omega-3 fatty acids, such as Echium spp., black currant, and Borago 

officinalis. No adverse effects on human subjects were reported in a study of healthful effects 
85

associated with consuming soybean oil from MON 87769 (containing SDA) ((Lemke et al., 

2010)). Many fish species have measureable content of SDA (Table X-2 (Monsanto, 2010b)) and 

fish oil is extensively consumed for the benefit of providing the long chain polyunsaturated fatty 

acids (Addendum to petition (Monsanto, 2010b)).

Monsanto measured compositional aspects of MON 87769 soybean and compared these data 

with conventional soybean. As earlier noted, SDA and also gamma linolenic acid are not found 

in commodity soybean. Although the animal feed consultation with FDA is pending, submitted 

data showed that these new components are both intermediates in mammalian systems during 

production of DHA and EPA, and also are found in the environment in numerous other plant and 

animal sources. Linoleic acid (18:2) is decreased to about 41% of control percentage, and this 

altered MON 87769 soybean constituent is similar to that found in canola oil. Statistically

significant but small differences were observed in the comparisons of the A3525 conventional 

variety to MON 87769 soybean in the concentrations of several fatty acids (16:0 palmitic, 18:0 

stearic, 18:1 oleic, 18:3 alpha linolenic acid, 20:0 arachidic, 22:0 behenic). APHIS evaluated 

these differences in composition and has determined that those reported for MON 87769 soybean 

either fall within the typical commercial range for percentage composition or the 99% tolerance 

interval for commercial soybean composition (Monsanto, 2010b). Several amino acid 

percentages, % dry weight of proximates (protein and carbohydrate), and two isoflavones were 

also different from controls, but these also were within either the range of commercial values or 

the 99% tolerance level for commercial soybean (Monsanto, 2010b). 

MON 87769 soybean was produced to make available an additional source of SDA, which is a 

healthful omega-3 fatty acid that can be obtained from other plant sources, fish and algae on 

commercial scales (Monsanto, 2010b). Monsanto 87769 stearidonic acid soybean would likely 

be a lower cost alternative to marine-derived omega-3 oils (Kennedy et al., 2012). The key

contribution of SDA is that it is a precursor for the fatty acids DHA and EPA, which have been 

shown by a variety of clinical and research reports to reduce adverse cardiovascular incidents, 

reduce inflammatory mediators, reduce cancer risk and inhibit tumor growth (see review in 

Whelan, 2006). EPA alone may influence these outcomes, but administration of SDA can equal 

the impacts on these conditions (see review in Whelan, 2006).

The Preferred Alternative impacts to human health differ from the No Action Alternative with 

regard to potential human health benefits associated with consumption of the oil from this crop. 

Monsanto’s analysis (Monsanto, 2010b) suggests that enhancing food oils with the soybean oil 

extracted from the MON 87769 soybean may have a positive impact on human health when used 

in many foods for which it is suitable. The addition of SDA using oil derived from MON 87769 

soybean oil may benefit many health conditions, both as preventative and as remedial. The 

extent to which positive benefits may be observed is contingent upon the market share of the 

MON 87769 soybean and the types of food products to which manufacturers add the modified 

oil, but it is likely to begin to be incorporated into processed foods only after a lengthy period of 

food ingredient adaptation and then marketing to the public to attain acceptance. 

Based on APHIS’ review of field and laboratory data and scientific literature provided by

Monsanto (Monsanto, 2010b), and safety data available on other GE soybean, APHIS has 

concluded that under this alternative, a determination of nonregulated status of MON 87769 

soybean would have no significant impacts on human health.
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Worker Safety

If MON 87769 soybean is adopted, growers during the course of production will be exposed to 

the same pesticides as those typical of other non-herbicide tolerant soybean varieties. As MON 

87769 soybean does not require different cultivation practices than currently available 

glyphosate-tolerant soybean, this level of herbicide exposure is expected to be the same as the 

No Action Alternative.

Soybean processing and manufacturing will not be altered by use of MON 87769 soybean, and 

workers will not be exposed to any new equipment or chemicals to which they had not already 

been exposed. The novel fatty acids stearidonic and gamma linolenic acid derive from two 

enzymes (desaturases) that are conserved across plant, animal and bacterial kingdoms, and which 

are ubiquitous in the human diet. Minor amounts of trans-SDA and trans alpha linolenic acid 

(trans-ALA) are also generated from processing of the novel fatty acids (Monsanto, 2010b). The 

oils found in MON 87769 soybean, including the novel ones, are also commonly found in other 

plants. Oils with substantial amounts of the new fatty acids are already being processed by the 

food and nutrients industries, and are extracted from other plant sources (gamma linolenic acid 

from borage oil and blackcurrant; SDA from Echium spp.) and thus would not provide novel 

exposures to workers in the edible oil processing and packaging industry. Monsanto submitted a 

GRAS Notice (for Foods Generally Recognized as Safe) for MON 87769 soybean to the FDA

(US-FDA, 2009b). FDA has no further questions about the characteristics of the oil, and safety 

of its use in foods (see Appendix A; GRAS Notice No. GRN 000283) (US-FDA, 2009a).

4.6 Animal Feed

The majority of the soybean cultivated in the U.S. is grown for animal feed, and is usually 

fed as soybean meal (Monsanto, 2010b). Soybeans intended for animal feed are generally 

cultivated as commodity products, although there are some consumers demanding specific 

physical or chemical characteristics to meet specific feed needs (Monsanto, 2010b). In these 

cases, the soybean meeting those specialized needs are cultivated as a specialty soybean 

crop. The cultivation practices necessary to maintain identity protection have been 

previously discussed in Section 2.2.5. 

Under FFDCA, it is the responsibility of feed manufacturers to ensure that the products they 

market are safe and properly labeled. Feed derived from MON 87769 soybean must be in 

compliance with all applicable legal and regulatory requirements. GE organisms for feed may

undergo a voluntary consultation process with the FDA prior to release onto the market. 

Monsanto initiated the consultation process with FDA for the commercial distribution of MON 

87769 soybean and submitted a safety and nutritional assessment of food and feed derived from 

MON 87769 soybean to the FDA on March 23, 2009 (BNF No. 00117) (Monsanto, 2010b). 

FDA is currently evaluating the submission.

4.6.1 No Action Alternative: Animal Feed

Under the No Action Alternative, soybean-based animal feed will still be available from 

currently cultivated soybean varieties, both conventional varieties as well as GE soybean that are 

no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of 
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the Plant Protection Act expressing herbicide tolerance. No change in the availability of these 

crops as animal feed is expected under the No Action Alternative.

4.6.2 Preferred Alternative: Animal Feed

Monsanto has submitted compositional and nutritional characteristics of MON 87769 soybean to 

APHIS (Monsanto, 2010b). As part of field trials, samples of MON 87769 soybean and 

conventional variety A3525 were collected from five different field trial locations during the 

2007-2008 growing season (Monsanto, 2010b). These samples were analyzed for comparable 

nutritional components, including proximate (protein, fat, carbohydrates, fiber, ash, moisture), 

vitamins, amino acids, fatty acids, and the antinutrient factors of soybean (which included lectin, 

trypsin inhibitors, isoflavones, and phytic acid) (Monsanto, 2010b). APHIS has reviewed 

Monsanto’s results and has concluded that with the exception of the changes in fatty acid 

composition, the levels of nutrients, anti-nutrients, and secondary metabolites in MON 87769 

soybean are not statistically different from those likely to be expressed by conventional varieties. 

The change in fatty acid composition is not expected to impact the value of MON 87769 

soybean as an animal feed, The total fat content of the oil is unchanged which is only about 

0.5% (minimum) (Iowa Soybean Association, 2010). The total saturated fatty acids and 

polyunsaturated fatty acids in MON 87769 soybean oil are similar to those found in 

conventional soybean. FDA has agreed that the soybean oil produced with MON 87769 

soybean has GRAS status (US-FDA, 2009a), and thus, these oils are not a risk to animals that 

consume meal. The desaturase proteins introduced into MON 87769 soybean are similar to 

those found in a wide variety of plants, fish and animals, and have been shown to have no 

toxic or allergenic potential (Monsanto, 2010b).

Based on this information APHIS has concluded that a determination of nonregulated status of

MON 87769 soybean would have no significant impacts on animal feed or animal health. 

Overall impacts are similar to the No Action Alternative.

4.7 Socioeconomic Impacts

4.7.1 Domestic Economic Environment

GE soybeans are cultivated on 93% of the U.S. soybean acreage (USDA-ERS, 2010a, 2010b). 

The U.S. acreage of soybeans planted has varied over time, but the USDA has noted that the 

acreage dedicated to soybean has declined in recent years as returns on investment favored corn 

production (USDA-ERS, 2008). Although acreage has declined, the yield per acre has continued 

to increase (USDA-ERS, 2008). Short-season varieties have provided northern growers with the 

option to replace wheat crops with soybeans (USDA-ERS, 2008). 

Soybean oil lost market share in the food industry early in the decade as consumers sought 

vegetable oils that were lower in trans-fatty acids; this trend has slowed with the availability of 

low-linolenic and high-oleic varieties of soybean (USDA-ERS, 2008). The decline in food uses 

was replaced by an increase in demand for commodity-grade soy oil for biodiesel production

(USDA-ERS, 2008).
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No Action Alternative: Domestic Economic Environment

Under the No Action Alternative, MON 87769 soybean and its progeny would continue to be 

regulated under 7 CFR part 340. Growers and other parties who are involved in production, 

handling, processing, or consumption of soybean would not have access to MON 87769 soybean

and its progeny, but would continue to have access to GE that are no longer subject to the 

regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection 

Act as well as conventional varieties. Domestic growers will continue to utilize currently

available traditional and GE soybean varieties based upon availability and market demand.

Preferred Alternative: Domestic Economic Environment

Monsanto anticipates that MON 87769 soybean will provide a niche product, which in five 

years, if all demand for SDA were provided by this variety, would equate to about 100,000 acres 

of MON 87769 soybean being grown in the U.S. (Monsanto, 2010b). Monsanto does not 

anticipate that MON 87769 soybean would change soybean production practices or increase 

soybean acreage (Monsanto, 2010b). Properties of MON 87769 soybean are not likely to replace 

substantial amounts of commodity acreage, and will not require significant additional acreage for 

the new soybean varieties. New niche food and industrial uses may be found for this oil, but at 

present, no large requirements for this variety can be foreseen. Existing soybean users will 

remain users of commodity soy oil, and small scale use of MON 87769 soybean oil may slowly

increase in the next five years to that predicted in Monsanto’s market analysis (see Appendix C 

of this EA).

Stewardship of MON 87769 Soybean

Soybean oil users who may have concerns about undesirable changes in standard properties of 

this modified oil have been identified by Monsanto, and dialogues have begun to solicit both 

specific issues of importance and to provide these stakeholders with relevant information 

(Appendix C; Addendum (Monsanto, 2010b)). As noted in Addendum 2 to the MON 87769 

soybean petition, these groups include trade organizations representing oil processors, elevators, 

grain and oilseed processors, agricultural businesses and exporters, bakers, and grocery

producers. Issues of commingling have been addressed in Addendum 1 (see for example, 

impacts to commodity soybean and meal, changes in oxidative and heat stability, acceptability of 

sensory properties and allowable changes in nutrition facts labeling). The issue of impacts of 

misdirected MON 87769 soybean was analyzed. Making standard assumptions for the size of a 

single truck delivery of an IP soybean and for the smallest soybean processor holding tank, the 

total SDA content of commodity oil would be 0.8% from a single such delivery. Maximal 

percentage of SDA in an elevator after misdirection would be 0.03-0.16% given standard 

elevator dimensions. A single truck inadvertently delivering one SDA soybean load to a 

commodity soybean ship would lead to SDA content of 0.0008%. In all these cases, the relative 

amount of the admixture would be extremely small, and as we show next, would not affect key

properties of commodity oil.

A number of assessments were made that showed to what extent mixture of MON 87769 

soybean would affect expected properties of commodity oil. To decrease the oxidative stability

(measured by the oxidative stability index falling below the range of that for commodity
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soybean), the mixture would require up to 12.5% of MON 87769 soybean (Figure 1, Appendix 

C). Monsanto also determined that commodity oil would tolerate up to 15% MON 88769 

Soybean without impact on formation of unacceptable levels of polar materials in commercial 

fryer conditions (Figure 3, Appendix 2). Commingling of MON 87769 soybean up to 15% 

content in the commodity oil had no impact on flavor of French fries (Figure 4, Appendix 2).

A key to the acceptability of soybean oil as a feedstock is that the product has a consistent and 

specific fatty acid composition (Cahoon, 2003). The identity protection system detailed above in 

Subsection 2.2.5, Specialty Soybean Production, provides controls to ensure that the product 

traits attained in the field are preserved up through the ultimate user. Monsanto intends to 

segregate the crop from commodity soybean at all stages, from seed production through and 

including handling , processing and use in a closed loop process, and to oversee a complete 

product stewardship plan involving all producers and users (Monsanto, 2010b).

Mechanisms to Maintain Product Identity

Monsanto has developed a Closed Loop Stewardship System (CLSS) that will avoid potential 

impacts to commodity soybean oil (Appendix 2). Procedures and processes for MON 87769 

soybean have been designed for production integrity at all steps of viable seed and grain 

production, and through storage, grain elevators, oil and meal processors, and downstream 

entities for product identity assessment (Appendix 2; Addendum 1 (Monsanto, 2010b)). The 

CLSS will require terms and conditions for quality management systems, quality assurance and 

quality control. After obtaining international regulatory approvals for MON 87769 soybean, 

Monsanto will continue to refine and update the stewardship system for long term 

implementation. Key stakeholders will continue to be consulted as stewardship of MON 87769 

soybean continues. 

Contract buyers of MON 87769 soybean will be required to identify MON 87769 soybean

beginning with delivery at grain elevators; sampling for MON 87769 soybean grain will be 

required by contract for each arriving truckload. Processors and downstream users will use 

standard oil analytic procedures to provide oil constituent analysis at critical control points in the 

CLSS, as well as segregation and adherence to standard protocols required by contracts and 

agreements. 

In addition to contracts and agreements with Monsanto, product identity at all steps will be 

maintained because soybean sellers and oil processors are motivated to capture premium prices; 

routine adherence to protocols will also serve to maintain product identity. With these financial 

incentives and established procedures, the soybean industry will observe best management 

practices, use appropriate identification procedures, employ proprietary inventory systems and 

ensure traceability requirements. Using the proposed measures, which would be established by

contractual agreements with growers, elevators and processors, Monsanto aims to provide 

stewardship during all phases of production for stakeholders invested in all uses of soybean oil.

The vegetable oil industry is experienced at handling multiple IP soybean types and the oils 

extracted from them (Appendix 2 and Addendum 1 (Monsanto, 2010b)). Oil processors and 

users are able to appropriately characterize, segregate and blend for special functions the identity

preserved oils available to them for attaining the final quality needed in specialty products. The 
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Monsanto Vistive low-linolenic variety has been available to oil users for six years, and is grown 

extensively in 12 states (Appendix 2, www.vistive.com). Monsanto’s oversight mechanisms for 

production of Vistive low linolenic oil as well as IP mechanisms used for other identity

preserved soybean production both have similarities to the plan described here for product 

stewardship of MON 87769 soybean oil. Monsanto has provided the leadership for production of 

the low linolenic IP specialty oil, and thus, has multiple years of relevant experience in 

establishing and maintaining processes of appropriate stewardship for MON 87769 soybean and 

its oil products. Monsanto demonstrated that they would work with processors to assure 

adequate testing methods and quality processes were applied.

Market Share/Uses of MON 87769 Soybean

The majority of soybean cultivated in the U.S. is grown as a commodity product intended for 

animal feed. Specific market uses for specialty soybean products generally require adherence to 

specialty crop practices to preserve identity from seed production through harvesting, handling, 

and processing. A premium is paid to growers and processors for delivering product that meets 

these desired purity and quality standards (Elbehri, 2007; Lee and Herbek, 2004; Muth et al., 

2003; Pritchett et al., 2002; Smyth and Phillips, 2002a; Sundstrom et al., 2002). MON 87769 

soybean is considered a specialty soybean product and will be marketed in accordance with other 

high-value specialty food crop products (Monsanto, 2010b). To maintain the identity of the 

product soybeans, growers cultivating MON 87769 soybean may potentially incur increased 

costs for production and distribution throughout the supply chain (mostly IP costs). The extent 

to which MON 87769 soybean displaces other cultivated varieties cannot be predicted, as market 

segment is contingent on variety acceptance by both growers and consumers. 

Monsanto has developed MON 87769 soybean to provide an enriched oil source of SDA, which 

could be made available for food incorporation and for cooking. Commercial plant sources of 

SDA are limited and production quantities are difficult to ascertain, and fish oil sources of 

stearidonic and other long chain polyunsaturated fatty acids may not be acceptable to customers 

who do not wish to consume fish or to producers who do not favor the organoleptic or stability

properties of fish oil. Of the fish oil used in the U.S., about 14% is used in functional foods 

(Addendum 1 (Monsanto, 2010b)), which is one category to which SDA soybean will contribute. 

Monsanto proposes that the availability of SDA soybean will allow incorporation of the omega-3 

fatty acid into a wider range of food categories than existing SDA sources (Monsanto, 2010b). 

The increase projected through 2016 for omega-3 oils is 26.6%, about twice the present rate, and 

Monsanto proposes that the product will get all the increase. Thus, by 2016, Monsanto expects 

that MON 87769 soybean will be produced on 100,000 acres (Appendix C: Addendum 1 

(Monsanto, 2010b)). The MON 87769 soybean modified oil may also be a candidate oil for use 

in industrial products, since increased unsaturation may be useful in some applications, but the 

potential for this use cannot easily be estimated.

The main variables that determine outcomes for market share will be consumer acceptance 

(including that of food and industrial producers) and price of the commodity (Giannakas and 

Yiannaka, 2010). The greatest impacts will occur if the price of the novel soybean oil is 

relatively low, and consumer evaluation is highly favorable, which could result in an increasing 

number of products using oil from MON 87769 soybean. In this event, increased economic 

benefit would ensue to producers of the novel oil. Because these variables associated with MON 
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87769 soybean cannot be determined at present, no definitive conclusions can be made about 

market share impacts on soybean oil producers.

Potential Market Response to MON 87769 Soybean

Changes in total acreage of specific oilseed crop varieties in response to market demand can be 

readily observed. In 1995, the National Sunflower Association began developing sunflower 

varieties to take advantage of pending label requirements for trans fatty acids (NSA, 2006). By

2005, it was estimated that 80% of the U.S. sunflower acreage was planted in NuSunTM, a 

conventionally produced high-oleic variety (NSA, 2006). This transition occurred after the food 

industry conducted extensive studies of food chemistry, supported by human health assessments

(NSA, 2006). The usefulness of low linolenic soybean has allowed growth of the market, from 

800,000 acres in 2006 (Fehr, 2007) to a total of 3 million acres since 2005 (Monsanto, 2010b). 

The low linolenic soybean however, has uses as a modified commodity product, and not as a 

specialty oil that MON 87769 soybean would supply. 

The value to the consumer from the changes presented in MON 87769 soybean is a direct 

function of the chemical changes associated with the changed concentrations of the fatty acids. 

The beneficial results of incorporating SDA into consumer products and into finished 

manufactured foods will be a point advanced by food marketers. Enough scientific evidence is 

available for use of EPA, DHA (SDA is a precursor for these in human metabolism) as a food 

supplement in a conventional food to make certain health claims (see summary of U.S. Agencies 

statements,(Council for Responsible Nutrition, 2005)), and these should not exceed FDA 

statements for reducing the risk of coronary heart disease, “Supportive but not conclusive 

research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of 

coronary heart disease” (US-FDA, 2004 ). Claims supported by the European Food Safety 

Authority supported additional claims about the health benefits for maintaining normal eye and 

brain function, and could be the basis for marketing claims if products were made for export to 

European markets (EFSA (European Food Safety Administration), 2011). The size of such 

domestic markets is difficult to analyze, but gives credence to the market forecast offered by

Monsanto for potential use of omega-3 uses for MON 87769 (Addendum 1 (Monsanto, 2010b)). 

This product will have decreased oxidative stability relative to commodity soybean oil 

(Addendum 1 (Monsanto, 2010b)) and thus may not be useful for certain industrial lubricant uses

(Monsanto, 2010b; USB, 2010b). Saturated fats in MON 87769 soybean are not lower than 

commodity soybean oil (Table 14) so that this parameter does not improve use as a biodiesel fuel 

over commodity soybean oil because these fatty acids may be one factor that improves cold 

weather performance (AGRA, 2009; Graef et al., 2009; Knothe, 2005; Monsanto, 2010b)

performance. Cetane numbers, which are a measure of the ignition quality of an oil, will likely

be reduced compared to commodity soybean oil, since increased unsaturation depresses this 

value (see Table 7, Moser, 2009), and SDA itself and modestly increased linolenic acid both 

increase unsaturated fatty acids. Lower cetane numbers would not offer improvements over 

commodity soybean oil. 

The costs of developing and managing IP specialty soybean crops have been identified as a 

barrier to the market, so price premiums such as noted above are essential for these specialty

soybeans to be adopted (Pritchett et al., 2002). The cost for entry into the IP system has been 
92

estimated as high as 25% above the cost of conventional crop production (Smyth and Phillips, 

2002a). Consumers of specialty crops also have cost burdens associated with these crops. In 

addition to the costs incurred for specialty crop production, specialty crop consumers accrue 

added IP costs from five general activities: certifying and obtaining ingredients; testing 

ingredients or final products; separating equipment and facilities; scheduling production and 

conducting changeover procedures; and conducting recordkeeping (Muth et al., 2003). 

These IP management costs may be offset by premium value received for the crop and the 

product, as well as increased yields for certain IP varieties. Pritchett reports that specialty

soybean yields are generally higher than those reported for commodity soybeans, which he 

attributes to either the managerial talent of the specialty grower or higher land quality which is 

recognized and optimized by the grower (Pritchett et al., 2002). There is no information whether 

these market entry costs for cultivation and use of specialty soybean would be offset by

increased yields and premium prices for the products of MON 87769 soybean. Irrespective of 

the value added application of oils derived from MON 87769 soybean, adherence to soybean IP

practices will be essential to ensure that the crop value is preserved.

In the alternative, inadvertent use of MON 87769 soybean by a user desiring an alternative fatty 

acid composition may give rise to negative impacts to those consumers. For example, when 

polyunsaturated fatty acids are high, rapid oxidation can occur in fried foods and result in 

undesirable taste and odor (Addendum (Monsanto, 2010b)). Also, the taste commonly

associated with fried food is due to the presence of linoleic acid (AGRA, 2009) and MON 87769 

soybean will have decreased content. High-oleic acid soy oils are not considered ideal for fried 

food applications (AGRA, 2009) and high levels of linolenic acid contribute to oxidation during 

frying and over extended storage times (Rosseli, 1998). If MON 87769 soybean were 

inadvertently used in high proportions for fried food applications, the resulting food products 

would likely be unacceptable. As noted in the Addendum, however, at low levels of admixture of 

MON 87769 soybean with commodity soybean oil (up to 15%), no adverse effects can be 

detected on either oxidative stability or on flavor perception (Appendix C: Addendum 1, 

(Monsanto, 2010b))

The need to maintain identity and control product characteristics are similar concerns for

industrial applications. Oils with high concentrations of linolenic acid are comparable to linseed 

oil and are very desirable in the coatings industry where they are used to enhance drying of 

paints, inks, and varnishes (Cahoon, 2003). SDA and the less saturated linolenic acid, may have 

decreased oxidative stability (Appendix 2) and thus be valuable in this type of application. 

Vegetable oil polyols formed via epoxides are used in production of polyurethanes, When 

vegetable oils contain high levels of specific unsaturated fatty acids, epoxidized soybeanproduced oils can be produced that lead to higher quality chemicals with more homogeneous 

character (Cahoon, 2003). While the inadvertent substitution of one specialty oil for another 

specialty oil is highly unlikely, the results of such an accidental substitution in the industrial 

sector may nonetheless be substantial. If the IP practices do not maintain the identity of MON 

87769 soybean and either conventional soy oil or other specialty oils, desired oil composition 

would be compromised and the product would not meet its specifications. Those entities 

crushing or using oil from MON 87769 soybean will be required under Monsanto’s stewardship 

plan to be continually monitoring fatty acid content of oil, both upon arrival and after processing. 

Those oil industry entities that do not purchase or expect MON 87769 soybean derived oil will 
93

also need to monitor fatty acid content of oil products, which for standard quality assurance 

programs would be done under any circumstance, but also because various specialty soybean oils 

besides MON 87769 are also present in the marketplace, which could also have impacts on fatty

acid content.

Identity preserved product such as low-linolenic varieties provide the grower with a premium 

price as high as $1.25 per bushel (Conley et al., 2008) but more recently have declined to 50-60 

cents per bushel (Wallaces Farmer, 2010). In 2005, when Monsanto introduced the low-linolenic 

soybean “Vistive” variety, food producers such as Kellogg noted that there was a high demand 

and significant shortage for soy oils with these traits (Woznicki, 2005). MON 87769 soybean

market share will be contingent on a demonstrated price and high yield potential as well as 

consumer and producer preference to other modified fatty acid soybean varieties. 

Net income differentials cannot be projected, since the net income of soybean producers growing 

conventional soybean is not easily predicted (see regional differences in years 2009-10) (USDAERS, 2010e). However, as Monsanto anticipates that MON 87769 soybean would be cultivated 

as a specialty crop under an IP system, resulting domestic socioeconomic impacts are expected 

to be similar to the No Action Alternative. Similar to other specialty crops currently being 

grown under IP systems, resulting economic benefits are contingent on adherence to IP practices 

at all stages of MON 87769 soybean cultivation and production.

4.7.2 Trade Economic Environment

Although soybean oil constitutes only a small percent of soybean weight (approximately 19%), 

soybean oil accounts for up to 65% of all vegetable oil and fat consumed in the U.S. (USDAERS, 2010e). The worldwide market share is not as high. Until 2005, soybean oil was the 

largest source of vegetable oil worldwide (USDA-ERS, 2010e). In 2005, however, palm oil 

overtook soybean oil in volume of production; palm oil and rapeseed oil (canola) production are 

expected to continue to grow over the next few years (USDA-ERS, 2010e). In 2009, the U.S. 

exported 1.3 billion bushels (34.9 million metric tons) of soybean, which accounted for 46% of 

the world's soybean exports (SoyStats, 2010g). In total, the U.S. exported $16.5 billion U.S. 

dollars (USD) worth of soybean and soybean products in 2009 (SoyStats, 2010b). China is the 

largest export market for U.S. soybean with purchases totaling $9.2 billion. Mexico is the 

second largest export market with sales of $1.3 billion in the same year (SoyStats, 2010b). Other 

significant markets include Japan and the EU.

The global demand for soybeans is expected to increase by a full third over 2010 consumption in 

the next ten years, with China accounting for 80% of the expected increase in total demand

(FAPRI, 2009; Hartnell, 2010). China and India are predicted to import 46% of the total 

soybean market by 2018/2019 (FAPRI, 2009). The USDA has predicted that U.S. exports will 

remain flat during much of this period, as a result of increase in domestic consumption and 

competition from South America (FAPRI, 2009; USDA-ERS, 2009). To a certain extent, 

competition with South American producers will be offset by increased demand from China

(FAPRI, 2009). The USDA predicts that the U.S. share of this export market could potentially

decline from the current 46% to 30% at the end of the decade (FAPRI, 2009; USDA-ERS, 2009). 

It is also noted that as a result of higher prices for vegetable oils as a result of increased demand 

for food use as well as for biodiesel and other industrial uses, previously uncropped land in 
94

Brazil, Indonesia, and Malaysia are being brought into production for soybean and palm oil

(USDA-ERS, 2009). This will increase global competition for export market share.

Income benefits from cultivation of herbicide tolerant soybeans have been substantial. Global 

farm income has been estimated to have increased over 6% in 2007 as a consequence of adopting 

these varieties (Brookes and Barfoot, 2010; Hartnell, 2010). Global gains from adoption of 

herbicide-tolerant soybeans have been estimated as high as $7 billion per year (Hartnell, 2010). 

Continued expansion of these crops internationally will be an extension of consumer demand as 

well as government regulation of GE commodities. 

Costs of production also play a role in U.S. soybean export competitiveness. In Argentina, for 

example, the cost of herbicide-tolerant soybean production is substantially lower than U.S. costs 

because Monsanto was unable to patent the technology in Argentina (Brookes and Barfoot, 

2010). As a consequence, Argentinian growers are able to save seed and not pay technology fees 

or royalty fees on farm-saved seed (Brookes and Barfoot, 2010).

No Action Alternative: Trade Economic Environment

Approximately 93% of the soybean varieties currently cultivated in the U.S. are GE varieties

(USDA-ERS, 2010a, 2010b). All these GE soybean varieties are herbicide resistant. Specialty

soybeans comprise approximately 12% of the soybean acreage (MSA, 2009). U.S. soybeans will 

continue to play a role in global soybean production, and will continue to be a supplier in the 

international market. 

Under the No Action Alternative, there would be no changes to the existing soybean market.

Preferred Alternative: Trade Economic Environment

To support commercial introduction of MON 87769 soybean in the U.S., regulatory submissions 

will be made by the petitioner to countries that import significant quantities of soybean or its 

processed fractions from the U.S. and have established regulatory approval processes in place

(Monsanto, 2010b). These will include submissions to a number of foreign government 

regulatory authorities, including: Ministry of Agriculture, People’s Republic of China; Japan’s 

Ministry of Agriculture, Forestry, and Fisheries (MAFF ) and the Ministry of Health, Labor, and 

Welfare (MHLW); the Canadian Food Inspection Agency (CFIA) and Health Canada; the 

Intersectoral Commission for Biosafety of Genetically Modified Organisms (CIBIOGEM), 

Mexico; the European Food Safety Authority (EFSA); and the regulatory authorities in other 

soybean importing countries with functioning regulatory systems. As appropriate, notifications 

of importation will be made by the petitioner to importing countries that do not have a formal 

approval process. 

MON 87769 soybean is intended to be cultivated as a specialty GE soybean variety and the SDA 

soybean oil will be produced and processed using a closed loop stewardship system to capture 

the food quality value of the oil (Monsanto, 2010b). The cultivation of MON 87769 soybean is 

not expected to result in an increase in the total acreage devoted to soybean cultivation, although 

the allocation of acreage to specialty soybean cultivation could increase contingent upon market 

demand. As with the No Action Alternative, U.S. soybeans will continue to play a role in the 

global soybean market.
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To the extent that the modified fatty acid soybean oil derived from MON 87769 soybean

achieves market acceptance, it is conceivable that this soybean-based oil could displace other 

fish oils and small scale production of exotic SDA vegetable oils in the international market. 

Products potentially displaced by MON 87769 soybean oil may include crops producing oils 

from such plants of the genera Echium and Ribes (black current). Although MON 87769 soybean 

oil may not be used in food products to the exclusion of existing products, at least some 

diminution of other oils from commodity soybean, canola, corn and so forth may be marginally 

displaced in the production of food products augmented with the new soybean oil.

Consistent with the potential increase in international demand for this specialty oil product, as 

well as price competitiveness, a determination of nonregulated status of MON 87769 soybean

may have a positive benefit on U.S. exports as soy oil based on this product increases soybean 

oil sales. The international market share of MON 87769 soybean as specialty variety is 

contingent on global vegetable oil market requirements, food processor acceptance, consumer 

preference, demonstrated availability of the product, and price competitiveness (Monsanto, 

2010b). However, with an inability to predict the size of these variable inputs, APHIS cannot 

reliably foresee the outcome for an increase in world market share of soybean resulting from 

planting of this variety.

Global sensitivities to GE products, including international restrictions on import of GE products 

and inability of the petitioner to gain local approval for cultivation or importation, will continue 

to impede trade with those countries. These challenges to international trade in GE products are 

already in place. Restrictions on international trade in GE products, including MON 87769 

soybean, are unlikely to change with a determination of nonregulated status of MON 87769 

soybean. 

A determination of nonregulated status of MON 87769 soybean will not adversely impact the 

trade economic environment and could potentially enhance it through the subsequent demand for 

the SDA MON 87769 soybean line and its oil products. The MON 87769 soybean follows 

trends in the continuing development of specialty soybeans with modified fatty acid profiles. 

The trade economic impacts associated with a determination of nonregulated status of MON 

87769 soybean are anticipated to be very similar to the No Action Alternative.

4.7.3 Social Environment

The social environment evaluated in this subsection relates to the general soybean farm, as 

well as the individuals or workers employed by the businesses potentially impacted by this 

product, including food processers and industrial users.

No Action Alternative: Social Environment

Under the No Action Alternative, there would be no changes from the status quo impacts on the 

social environment surrounding soybean farming, food processing, or industrial uses. The 

cropping and marketing decisions currently made by soybean growers are unlikely to change 

with the selection of this alternative.

Preferred Alternative: Social Environment
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MON 87769 soybean is not intended to confer any competitive advantage in terms of weed 

management or to extend the range of cultivation outside of existing cultivation areas. Monsanto 

expects that MON 87769 soybean will be cultivated as a specialty crop, with the SDA soybean 

oil produced and processed under existing identity protection systems to capture the food quality 

value of the oil (Monsanto, 2010b). Consistent with the expectations that this variety is to be 

cultivated as a specialty crop, a determination of nonregulated status of MON 87769 soybean is 

not expected to result in an expansion of the number of soybean acres, since oil from the variety

will likely replace existing oils from soybean on a highly limited scale. Soybean acreage is 

expected to remain stable, and overall impacts relative to the total soybean market system are 

similar to the No Action Alternative. 

To the extent that MON 87769 soybean is accepted by producers and consumers, MON 87769 

soybean has the potential to displace other specialty soybean varieties, but given the expected 

market growth of the variety, is expected to have no significant impact. Only 0.5% of the 

existing acres of soybean in the affected area are likely to be planted to the MON 87769 soybean. 

Those growers currently cultivating specialty soybean varieties have already invested in 

equipment and practices to maintain the identity of the product from seed through harvest and 

processing and would not be impacted by this change. To the extent that a grower currently 

cultivating commodity soybean elects to cultivate MON 87769 soybean, that grower will need to 

invest in handling equipment and management practices to capture and preserve the food quality

value of the oil. Growers adopting specialty varieties already make such investment decisions 

based upon perceived value and return on investment (Iowa State University, 2008). 

The soybean market also includes seed production, equipment manufacturers, handlers, and 

producers. Monsanto’s analysis of agronomic characteristics did not identify any differences 

between MON 87769 soybean and conventional varieties (Monsanto, 2010b). Monsanto expects 

that MON 87769 soybean would be cultivated, handled, and processed consistent with existing 

identity protection practices and systems (Monsanto, 2010b). Other than equipment required to 

maintain identity protection, no specialized equipment is required to cultivate, handle, or process 

MON 87769 soybean. 

Food processors potentially impacted by MON 87769 soybean include those parts of the industry

using soybean oil for frying, and cooking oil, and shortening products where shelf life and 

oxidative stability are important features. Monsanto intends to oversee the product using a 

closed loop stewardship system (Addendum 1) (Monsanto, 2010b). Because other modified oil 

products are already present in the commodity oil market and routinely handled by processors 

using standard industry processing methods and equipment, no new processes or equipment are 

required to introduce MON 87769 soybean. Thus, workers in these areas are not likely to be 

impacted by any major alterations of soybeans or of qualities of soybeans processed.

Monsanto has evaluated the market and trade applications of MON 87769 soybean, and has 

determined that this product will be used in a variety of uses, including margarine, shortenings, 

salad dressings, ready to eat foods, baked goods and a variety of other products (Addendum) 

(Monsanto, 2010b). In the event that MON 87769 soybean is introduced into a commodity oil 

unintentionally at the level of a misdirected truckload of soybean, or other unit delivery at a 

higher level of processing, the consequent mixture would be less than 15%, at which level, no 
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impacts on food ingredient labels or nutrition facts panels or changes to oxidative stability or 

food sensory properties would result (Addendum) (Monsanto, 2010b).

Potential impacts to industrial users of soybean products are similar. Existing identity protection 

measures are already in place to allow industrial users to manage feedstocks and products for 

specific applications and needs (Smyth and Phillips, 2002a; Sonka et al., 2004). No new 

equipment or practices are required to incorporate MON 87769 soybean into this industrial 

market. However, for industrial users that require close tolerances in the ratios of fatty acid to 

ensure product quality, continuous monitoring of properties of input oils may be necessary. This 

scrutiny may already have been enhanced, given that the industry has increasingly begun to 

encounter and already needs to manage an increasing range of different soy-based feedstocks, 

ranging from ultra-low linolenic acid varieties, through and including feedstock oils for blending 

from other crops, such as high-oleic and high linolenic varieties that have various uses (Cargill, 

2011; USB, 2010b). Thus, APHIS does not expect that changes to the social environment 

including workforce will be altered by entry of this variety into the soybean market. 

Consistent with the above assessment of potential impacts to the growers, and workforce in the 

food processing and industrial use categories, the impacts of a determination of nonregulated 

status of MON 87769 soybean are expected to be the same as the No Action Alternative.
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5 CUMULATIVE IMPACTS

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 reasonably foreseeable 

future actions. For example, the potential effects associated with a determination of 

nonregulated status of a GE crop in combination with the future production of crop seeds with 

multiple traits that are no longer subject to the regulatory requirements of 7 CFR part 340 or the 

plant pest provisions of the Plant Protection Act (i.e., “stacked” traits), including drought 

tolerance, herbicide tolerance, and pest resistance, would be considered a cumulative impact.

5.1 Assumptions Used for Cumulative Impacts Analysis

Specialty soybeans are cultivated to meet specific consumer needs. MON 87769 soybean is 

anticipated to be cultivated as another specialty soybean, offering growers and consumers an 

option for an omega-3 fatty acid easily converted by human metabolism to desirable fatty acids, 

EPA and DHA. Herbicide tolerant soybean is already extensively deployed in the seed market, 

as are a variety of specialty fatty acid ratios in other vegetable oil sources. No additional 

potential cumulative impacts to the commodity soybean market or the specialty soybean market 

can be reliably anticipated as a result of a determination of nonregulated status and cultivation of 

MON 87769 soybean.

MON 87769 soybean will be a readily produced source of omega-3 fatty acids, but not the only 

one, since there are other specialty vegetable oils that also provide SDA, such as the minor crops, 

borage, Echium spp. and blackcurrant. MON 87769 soybean successes in replacing these other 

high-oleic vegetable oils will be contingent upon producer and customer acceptance, availability

of the product, and price. Monsanto estimates that the market for marine oils in the U.S. is 

26,477 metric tons, and that this market and an annual increase in demand of 13.4% will provide 

the opportunity for use of this product.

Stacked varieties of soybean, those crop varieties that may contain more than one trait, are 

currently found in the marketplace and in agricultural production. In the event APHIS reaches a 

determination of nonregulated status, MON 87769 soybean may be combined with non-GE and 

GE soybean varieties by traditional breeding techniques. There is no assurance that MON 87769 

soybean will be stacked with any particular GE soybean trait (one no longer subject to the 

requirement of Part 340 and the provisions of the Plant Protection Act), as company plans and 

market demands play a significant role in those business decisions. APHIS’ regulations at 7 

CFR Part 340 do not provide for Agency oversight of GE soybean varieties no longer subject to 

the requirement of Part 340 and the plant pest provisions of the Plant Protection Act, nor over 

stacked varieties combining these GE varieties, unless it can be positively shown that such 

stacked varieties were to pose a likely plant pest risk. Predicting all potential combinations of 

stacked varieties is hypothetical and purely speculative.

5.2 Cumulative Impacts: Acreage and Area of Soybean Production

Cumulative effects of a determination of nonregulated status of MON 87769 soybean are 

unlikely. While APHIS expects that this variety will be stacked with glyphosate tolerance or 

other herbicide tolerance, as is a large percentage (93%) of other soybean crops in the U.S., it 
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will not lead to any significant changes in the specifics of soybean production. Neither the No 

Action Alternative nor a determination of nonregulated status of MON 87769 soybean are 

expected to directly cause an increase in agricultural acreage devoted to soybean production or 

those soybean acres devoted to GE soybean cultivation. It is anticipated that seed for this variety 

will not be marketed beyond five northern U.S. states (Monsanto, 2010b) and, in consideration of 

the low expected acreage (100,000 acres by 2016), will have no substantial impact on general 

soybean production. The availability of MON 87769 soybean is not expected to change the 

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

availability of GE and non-GE soybean varieties on the market under either alternative.

5.3 Cumulative Impacts: Agronomic Practices

Monsanto has stated that MON 87769 soybean would be stacked with either glyphosate or other 

available nonregulated herbicide resistance traits (Monsanto, 2010c). Monsanto has also 

indicated that glyphosate will be the continuing cornerstone of any multiple herbicide stack, with 

additional resistance complementing the activity, or allowing additional flexibility in designing 

weed control (Monsanto, 2010a). The adoption of herbicide tolerance traits complements 

conservation tillage practices by allowing farmers to substitute herbicide application for some 

tillage operations as a weed management practice (NRC, 2010). Herbicide usage trends since the 

adoption of GE crops are the subject of much debate, with initial assessments indicating a 

decline in herbicide use in the early years of herbicide-tolerant crop production (Carpenter et al., 

2002) that some argue was then followed by an increase in the volume of herbicide usage as the 

technology spread (Benbrook, 2009)). Others report a continuing decline in herbicide use with 

the adoption of GE crops (Fernandez-Cornejo and Caswell, 2006), or relative stability in the 

amount of herbicide active ingredients applied to soybeans (Brookes and Barfoot, 2010). The 

contradictory findings have been attributed to the different measurement approaches used by

researchers, how different factors affecting pesticide use such as weather or cropping patterns 

were controlled for, and how the collected data was statistically analyzed (NRC, 2010). It is 

anticipated that herbicide use will continue the trends noted by Beckie and Tardif (Beckie and 

Tardif, 2012) associated with the wide use of glyphosate-tolerant soybean along with crops 

stacked with multiple herbicide resistances as they are available or become so, and that 

alternative herbicides will more frequently be used sequentially, or in mixtures, or as required in 

crop rotations, to manage herbicide resistant weed populations. 

Although weed control with excessive reliance on only glyphosate has possibly favored 

development of glyphosate resistance, such resistance was not an inevitable consequence of the 

use of glyphosate resistant crops, but mainly a consequence of failing to use total weed control 

management plans (Shaner et al., 2012) and indeed, use of any herbicide can lead to weed 

resistance (Heap, 2012). Growers have been provided with an array of tactics to deal with either 

existing resistant weeds, or to deter the development of these by seed providers (Monsanto, 

2012) or by local university extension specialists. These recommendations for glyphosate 

resistant soybean varieties include crop rotations, use of preplant residual herbicides, and tank 

mixes with residual or post emergent herbicides. The National Research Council (NRC, 2010)

summarized strategies that may be used by growers to avoid development of glyphosate-resistant 

weeds to include:
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 Developing a diversified weed management program using herbicides with different modes 

of action, either concurrently or sequentially (NRC, 2010).

 Using the full recommended herbicide rate and proper application timing for the most 

difficult to control weeds in the field (NRC, 2010).

 Scouting the fields after herbicide application to ensure that control has been achieved and to 

discourage weeds from reproducing or proliferating vegetatively (NRC, 2010).

 Incorporating cultural practices such as cultivation, tillage and crop rotation, where 

appropriate (NRC, 2010). 

Currently, thirteen weeds have been identified as glyphosate-resistant in the US (Heap, 2012), 

with seven of these weeds identified as difficult to control weeds in soybean: common ragweed 

(Ambrosia artemisiifolia), common waterhemp (Amaranthus rudis), giant ragweed (Ambrosia 

trifida), horsetail (marestail) (Conyza canadensis), Italian ryegrass (Lolium multiflorum), 

Johnsongrass (Sorghum halapense), and Palmer amaranth (Amaranthus palmeri) (Benbrook, 

2009). Because the U.S. 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, USDA has no regulatory authority over the subsequent use of herbicides on 

herbicide tolerant plants that may be stacked with the MON 87769 trait. 

Besides glyphosate, soybean growers have had other herbicide-tolerant variety options for 

soybean production; two mechanisms for glyphosate resistance are offered to growers: 

insensitive target enzyme and increased metabolism. In addition, LibertyLink®Soybean with 

glufosinate ammonium tolerance is available from numerous seed dealers (e.g., Stine Seed), as 

are STS soybeans, a conventionally derived resistance to ALS herbicides, which may be stacked 

with other resistance traits (e.g., Asgrow Seed). These options allow growers to reduce 

dependence on glyphosate, especially if glyphosate-resistant weeds are an important issue. 

Volunteer soybean is normally not a concern. Soybean is not winter hardy, and existing 

mechanical and chemical methods are available to manage the occasional volunteer soybean. 

Herbicides are available to control volunteer soybeans in corn, and wheat (above). These 

herbicides are suitable for post-emergent control of volunteer soybean. The challenges which 

growers face in managing glyphosate-resistant weeds is also not expected to differ between 

MON 87769 soybean stacked with glyphosate resistant trait and other glyphosate-tolerant 

varieties, and similar herbicides would be used in either crop for such weeds.

A determination of nonregulated status of MON 87769 soybean will not result in changes in the 

current practices of crop rotation and pesticide use. Studies demonstrate MON 87769 soybean is 

essentially indistinguishable from other soybean varieties (either herbicide tolerant ones, when 

stacked with an herbicide tolerant trait, or non-GE soybean when not stacked with an herbicide 

tolerant trait) in terms of agronomic characteristics, and cultivation practices would closely 

follow the herbicide tolerant GE or non-GE variety (Monsanto, 2010b). It is anticipated that 

herbicide use will continue the trends associated with the wide adoption of glyphosate-tolerant 

soybean and the emergence of glyphosate-resistant weeds, but that growers are increasingly 

cognizant of the risks of failing to respond to possible development of glyphosate resistance (in a 

2009 telephone survey 89% of growers were taking steps to minimize development of resistance 

(WSSA, 2010 )). APHIS has determined that there are no past, present, or reasonably 
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foreseeable actions that would aggregate with effects of the proposed action to effect changes in 

crop rotation, and pesticide use.

5.4 Cumulative Impacts: Soybean Seed Production

Based on current acreage trends, GE soybean varieties will likely continue to dominate the 

soybean market. Since 2007, the GE varieties of soybean have comprised 91 to 93% of the U.S. 

soybean acreage. Changes in the agronomic practices and locations for soybean seed production 

using MON 87769 soybean are not expected. The availability of MON 87769 soybean will not 

change cultivation areas for soybean seed production in the U.S.; no cumulative effects have 

been identified for this issue

5.5 Cumulative Impacts: Organic Soybean Production

A determination of nonregulated status of MON 87769 soybean is not expected to change the 

market demands for GE soybean or soybean produced using organic methods. A determination 

of nonregulated status of MON 87769 soybean will add another GE soybean variety to the 

conventional soybean market. Based upon recent trend information, adding GE varieties to the 

market is not related to the ability of organic production systems to maintain their market share.

5.6 Cumulative Impacts: Specialty Soybean Production

A determination of nonregulated status of MON 87769 soybean is not expected to change the 

market demands for GE soybean or non-GE soybean produced using specialty systems. MON 

87769 soybean is expected to be cultivated as a specialty soybean consistent with identity

preserved practices. From Monsanto’s market analysis for needs of the soybean product, in five 

years the acreage produced will likely be only 1% of total specialty soybean acreage, assuming 

that specialty soybean stays at current estimates of 12% of commodity soybean production 

(Monsanto, 2010b). Based on demonstrated agronomic characteristics and cultivation practices, 

and because the market share of specialty soybean varieties is unlikely to substantially change 

following the introduction of MON 87769 soybean, APHIS has determined that there are no past, 

present, or reasonably foreseeable changes that would impact specialty soybean producers and 

consumers. No cumulative effects have been identified for this issue.

5.7 Cumulative Impacts: Water Resources

Monsanto proposes that MON 87769 soybean will be stacked with a glyphosate tolerant trait or 

potentially with other herbicide tolerant traits no longer subject to the regulatory requirements of 

Part 340 and the plant pest provisions of the Plant Protection Act or with both (Monsanto, 

2010c). Current application rates of glyphosate for weed control with MON 87769 soybean are 

not expected to change. 

Although glyphosate is very soluble in water, it is strongly adsorbed to soils; consequently, 

glyphosate is unlikely to leach into groundwater or surface water runoff following application 

(Giesy et al., 2000; US-EPA, 1993b). However, Coupe et al. (Coupe et al., 2011) has shown that 

in agricultural basins with high glyphosate use rates, high overland runoff rates, and low flow 

through soil, glyphosate can be readily detected in surface waters. Relying on toxicological data, 

bioaccumulation and biodegradation studies, and acute and chronic tests on fish and other 
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aquatic organisms, EPA however, has determined that “the potential for environmental effects of 

glyphosate in surface water is minimal” (US-EPA, 1993b).

No cumulative effects on water use have been identified associated with a determination of 

nonregulated status of MON 87769 soybean. A determination of nonregulated status of MON 

87769 soybean will not change the water use and irrigation practices used in commercial 

soybean production.

5.8 Cumulative Impacts: Soil Quality

APHIS has not identified any cumulative effects to soils. Comprehensive phenotypic, 

agronomic, and ecological assessments conducted by the petitioner for MON 87769 soybean did 

not find significant differences between MON 87769 soybean and control soybeans for these 

characteristics (Monsanto, 2010b). The few differences that were identified were typically 

small, site specific, and unlikely to be biologically meaningful. Event MON 87769 soybean 

required the same soil, fertilizer, water and pest management practices as non-GE soybean 

(Monsanto, 2010b). Consequently, the phenotypic, agronomic, and ecological data presented by 

Monsanto (Monsanto, 2010b) support the conclusion by APHIS that MON 87769 soybean will 

not significantly modify soil characteristics associated with conventional soybean production 

practices. 

If MON 87769 soybean is stacked with herbicide tolerance traits, persistence of pesticides in soil 

may be modulated by cultivation (see review of runoff potential in conservation tillage versus 

no-till and runoff potential (Warnemuende et al., 2007)). The glyphosate tolerant trait would 

likely be stacked with this variety, and so glyphosate would be the predominant post-emergent 

herbicide applied to MON 87769 soybean, as it is with other glyphosate tolerant soybean. 

Glyphosate has been shown to rapidly dissipate from most agricultural ecosystems across a wide 

range of soil and climatic conditions, with a median soil half-life (the time it takes for half of the 

glyphosate to dissipate in the soil) of 13 days (Giesy et al., 2000). A survey reported by

Borggard and Gimseng (Borggaard and Gimsing, 2008) noted soil half-lives ranging from 1.2 to 

197 days, depending on a wide range of chemical and physical parameters of soil.

If MON 87769 were to be stacked with the glyphosate tolerant trait, this would present certain 

environmental benefits over other herbicides that may be used for control of weeds in non-GE 

soybean production (Cerdeira and Duke, 2006; Hin et al., 2001). 

Pesticide products approved for application to emerged weeds normally are applied with 

surfactants. Surfactants increase the permeability of the weed foliage to increase the foliar 

uptake of glyphosate and thereby improve the efficacy of the herbicide (Stock and Holloway, 

1993). Polyethoxylated alkyl amine (POEA) is the predominant surfactant used in formulated 

glyphosate products. Glyphosate and the POEA surfactant have similar soil dissipation rates and 

the same primary route of dissipation, i.e., microbial degradation (Giesy et al., 2000). The halflife of POEA in soil is estimated to range from 7 to 14 days (Giesy et al., 2000). On that basis, 

the POEA surfactant is expected to behave similarly to glyphosate in field soil, and an increase 

in residual soil concentrations (accumulation) of the POEA surfactant is not anticipated. 

Because MON 87769 soybean when stacked with glyphosate or other herbicide tolerance does 

not differ in its agronomic requirements from conventional soybean or other GE varieties 
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expressing glyphosate tolerance, agronomic practices associated with soil and land use are not 

expected to change with the availability of this new plant product. Based on these findings, and 

because the amount of soybean grown in the U.S. is unlikely to change by the introduction of 

MON 87769 soybean, APHIS has determined that there are no past, present, or reasonably 

foreseeable actions that would aggregate with effects of the proposed action to impact soil.

5.9 Cumulative Impacts: Air Quality

APHIS has not identified any cumulative effects for this issue. The use of MON 87769 soybean 

in commercial soybean production is not expected to cause any cumulative effect on air quality 

because APHIS does not anticipate any changes in soybean production practices or an expansion 

of soybean acreage as a result of a determination of nonregulated status of MON 87769 soybean. 

The consequences of the Preferred Action Alternative on commercial soybean production and 

acreage are the same as for the No Action Alternative.

5.10 Cumulative Impacts: Climate Change

APHIS has not identified any cumulative effects for this issue. The use of MON 87769 soybean 

in commercial soybean production is not expected to cause any cumulative effect on climate 

change because APHIS does not anticipate any changes in soybean production practices or an 

expansion of soybean acreage as a result of a determination of nonregulated status of MON 

87769 soybean. The consequences of the Preferred Action Alternative on commercial soybean 

production and acreage are the same as for the No Action Alternative.

5.11 Cumulative Impacts Animal Communities

Soybean may be used by mammals and birds, and diverse numbers of insects may feed on the 

vegetative parts of the plant, or feed on other arthropods that feed on the soybean grain. 

Monsanto data for food and feed safety has established substantial evidence that the MON 87769 

soybean is safe for long term consumption, since no acute impacts could be identified. Dietary

exposure to the two new proteins expressed by MON 87769 is not a risk to human or animal 

health; the proteins are not toxic and fatty acids produced are common in the environment, 

produced by some other plants, fish and algae. There are no composition differences between 

this and conventional soybean, except for increased production of SDA, gamma linolenic acid 

and some expected decreases in other fatty acids. No differences in insect feeding damage to 

MON 87769 soybean and the comparator, conventional variety A3525 were observed over two 

years (Table I-5 and I-6) (Monsanto, 2010b). No significant cumulative impacts to animals or 

insects that feed on soybean expressing MON 87769 soybean would follow a decision to choose 

the Preferred Alternative.

5.12 Cumulative Impacts: Plant Communities

If MON 87769 soybean is stacked with the glyphosate tolerance trait growers would continue to 

use glyphosate predominately for post-emergent weed control. The Roundup Ready®soybean 

system has become the standard weed control program in the U.S. cultivation of soybean. 

Approximately 92% of the U.S. soybean acreage is planted in Roundup Ready®soybean 

varieties. Monsanto anticipates that MON 87769 soybean will not replace commodity type 

glyphosate-tolerant soybean varieties previously found to no longer be subject to the requirement 
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of Part 340 and the plant pest provisions of the Plant Protection Act. Rather, MON 87769 

soybean will remain a minor product with limited acreage. While any broad spectrum herbicide 

application has the potential to impact off-site plant communities, the impacts of planting MON 

87769 soybean expressing glyphosate tolerance will not be novel or extensive. Accordingly, the 

cultivation of MON 87769 soybean is not expected to result in an increase in the application of 

glyphosate or changes in herbicide treatments when compared with existing glyphosate-tolerant 

soybean varieties that are no longer subject to the regulatory requirements of 7 CFR part 340 or 

the plant pest provisions of the Plant Protection Act.

5.13 Cumulative Impacts: Gene Flow and Weediness

One introduced gene expected to be stacked in the MON 87769 soybean is the cp4 epsps gene, 

which confers tolerance to the herbicide glyphosate. This gene is commonly found in other 

Roundup Ready®crops (USDA-APHIS, 2010c). No data have been presented to suggest that the 

incorporation of the cp4 epsps gene allows soybean to survive and reproduce without human 

intervention (USDA-APHIS, 2010c). 

The soybean industry has identity protection measures in place to restrict pollen movement and 

gene flow between soybean fields through the use of isolation distances, border and barrier rows, 

the staggering of planting dates and various seed handling, transportation, and ginning 

procedures (Bradford, 2006; NCAT, 2003; Sundstrom et al., 2002). As a specialty soybean 

variety, MON 87769 soybean would be cultivated within these identity protection practices. In 

addition, there is no evidence that horizontal gene transfer and expression of DNA occurs 

between soybean and soil bacteria or unrelated plant species under natural field conditions, and 

even if this did occur, proteins corresponding to the transgenes are not likely to be produced. 

Gene movement between sexually compatible soybean varieties is no greater for MON 87769 

soybean than it is for other non-GE or GE cultivars. In its PPRA, APHIS assessed the weediness 

potential of MON 87769 soybean based on the introduced Primula juliae delta-6 desaturase 

(Pj.D6D) and the Neurospora crassa delta-15 desaturase (Nc.Fad3) genes controlling fatty acid 

composition (USDA-APHIS, 2010c). In each case, the changes introduced in the MON 87769 

soybean were deemed to not present a weediness risk (USDA-APHIS, 2010c). Based on the 

scientific evidence, APHIS has not identified any cumulative effects on gene movement that 

would occur from a determination of nonregulated status of MON 87769 soybean. From data 

presented by Monsanto on those agronomic characteristics likely to be associated with a change 

in weediness of the crop, there were no differences that were found between the host soybean 

and the genetically engineered MON 87769 soybean (USDA-APHIS, 2010c); APHIS concluded 

that potential for weediness of MON 87769 was unlikely.

5.14 Cumulative Impacts: Microorganisms

Cultivation of MON 87769 soybean is highly unlikely to have direct toxic effects on 

microorganisms. The glyphosate tolerant trait would likely be stacked with this variety, and 

therefore glyphosate would likely be the predominant post-emergent herbicide applied to MON 

87769 soybean, as it is with other glyphosate tolerant soybean. Microorganisms produce 

aromatic amino acids through the shikimate pathway, similar to that in plants (USDA-FS, 2003). 

Because glyphosate inhibits this pathway, it could be expected that glyphosate would be toxic to 

microorganisms. Glyphosate use has been identified as potentially causing increases in certain 
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disease-causing microbes (Fernandez et al., 2009; Kremer and Means, 2009). Reported increases 

in infections in cereal crops from pathogenic soil fungi have in some cases been determined to be 

more closely related to reduced tillage and continuous cropping using herbicide-tolerant crops, 

whereas in others, application of glyphosate correlated with increased bacterial species 

(Fernandez et al., 2009). The U.S. Forest Service, while acknowledging that in some cases, 

increases in soil pathogens following glyphosate treatment can be detected, “there is no 

indication that the transient enhancement in populations of soil fungi or bacteria will result in 

any substantial or lasting damage to soil ecology” (USDA-FS, 2003).

Because any microorganism is already extensively exposed to glyphosate, it is unlikely that any

new organisms would be impacted. Therefore, the likelihood of adverse cumulative effects on 

microorganisms following the introduction of MON 87769 soybean is minimal.

5.15 Cumulative Impacts: Biodiversity

Cultivation of MON 87769 soybean is highly unlikely to have direct toxic effects on non-target 

animals and microorganisms and is likely to be neutral to biodiversity compared with 

conventionally managed GE and non-GE soybean. Because any nontarget plants are already 

extensively exposed to glyphosate, it is unlikely that any new plants will be impacted. 

Therefore, the likelihood of adverse cumulative effects on non-target organisms and biodiversity

following the introduction of MON 87769 soybean is minimal.

The use of genetically modified soybean such as MON 87769 soybean when stacked with 

glyphosate tolerance may improve biological diversity by providing growers the opportunity to 

use conservation practices. Incorporation of herbicide tolerance in the crop facilitates the grower 

adoption of conservation and no-till strategies, improved soil porosity, enhancing soil fauna and 

flora (CTIC, 2010a), increasing the flexibility of crop rotation, and facilitating strip cropping 

(Fernandez-Cornejo et al., 2002), each of which contributes to the health of the faunal and floral 

communities in and around soybean fields thereby promoting biodiversity (Palmer et al., 2010; 

Sharpe, 2010).

Based on available scientific data, the changes in fatty acid composition associated with MON 

87769 soybean are not expected to directly or indirectly affect plants, animals or biodiversity. 

The genes responsible for the change in fatty acid composition are endogenous to the soybean 

and are thus already a part of the soybean cultivation environment. The U.S. EPA has reviewed 

the safety of the CP4 EPSPS protein and has established a tolerance exemption for the protein 

and the genetic material necessary for its production in or on all raw agricultural commodities 

((US-EPA, 1996); 40 CFR§174.523). The lack of any documented reports of adverse effects 

since the introduction of other Roundup Ready®crops in 1996 suggests the safety of its use. The 

CP4 EPSPS protein expressed in MON 87769 soybean is the same as that previously reviewed 

by the U.S. EPA, accordingly, MON 87769 soybean is anticipated to be safe for animal 

consumption with regard to the cp4 epsps gene.

APHIS has determined that there are no impacts from past, present, or reasonably foreseeable 

actions that would aggregate with effects of the proposed action to create cumulative impacts or 

reduce the long-term productivity or sustainability of any of the resources associated with the 

ecosystem in which MON 87769 soybean is planted (USDA-APHIS, 2010c).
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5.16 Cumulative Impacts: Human Health

5.16.1 Cumulative Impacts: Worker Safety

MON 87769 soybean is not expected to increase the total acreage of soybean production or the 

use of GE soybean. Monsanto anticipates that MON 87769 soybean will be a minor crop, 

produced to fill a small market need. To a limited extent, if stacked with an herbicide tolerant 

trait, MON 87769 soybean would simply replace a small percentage of acres of the herbicidetolerant soybean cultivars already on the market today. As APHIS analyzed in the Proposed 

Alternative, no hazards of exposure to the new fatty acids exist and therefore cumulative impacts 

are unlikely. 

Monsanto is expected to stack MON 87769 soybean with the glyphosate tolerance trait 

(Monsanto, 2010c). The introduced protein for the tolerance is the CP4 EPSPS protein derived 

from Agrobacterium sp. The U.S. EPA has reviewed the safety of the CP4 EPSPS protein and 

has established a tolerance exemption for the protein and the genetic material necessary for its 

production in or on all raw agricultural commodities ((US-EPA, 1996); 40 CFR §174.523). This 

exemption was also based on a safety assessment for allergenicity that included rapid digestion 

in simulated gastric fluids, lack of homology to known toxins and allergens, and lack of toxicity

in an acute oral mouse gavage study. The lack of any documented reports of adverse effects 

since the introduction of other Roundup Ready

®

crops in 1996 suggests the safety of its use. 

Worker safety issues related to the use of glyphosate and other U.S. EPA registered pesticides 

during conventional and GE soybean production should remain the same. If a grower replaces a 

non-herbicide-tolerant soybean variety with MON 87769 soybean it would be expected that there 

would be a corresponding increase in the post-emergent use of glyphosate. To the extent that 

such changes result in the replacement of more toxic herbicides with glyphosate, the change 

should positively benefit worker safety. 

The CP4 EPSPS protein likely to be expressed in MON 87769 soybean is the same protein 

previously reviewed by the U.S. EPA. Accordingly, worker safety risk associated with 

cultivation of and exposure to MON 87769 soybean is the same as the No Action Alternative.

5.16.2 Cumulative Impacts: Public Health

APHIS determined no significant adverse impacts on human health from consumption of the oil 

derived from MON 87769 soybean, although certain potential beneficial impacts may be 

possible. However, because Monsanto has decided to stack tolerance to the herbicide glyphosate 

with MON 87769 soybean, APHIS considers briefly the possible impacts of the gene on human 

health. Similar products are no longer subject to the regulatory requirements of 7 CFR part 340 

or the plant pest provisions of the Plant Protection Act and have been used for general cultivation 

beginning in the mid-1990s with the introduction of Roundup Ready® products providing 

tolerance to glyphosate with the introduction of the cp4 epsps gene. In each case, FDA and U.S. 

EPA reviews and approvals determined that the products met the agency’s review criteria for 

approval. The cultivation of these existing crop products would not change under either 

alternative. Both characteristics have been successfully cultivated in multiple crops in the 

ensuing years with no evidence of human health impacts.
107

The CP4 EPSPS protein confers tolerance to glyphosate. This protein is structurally homologous 

and similar functionally to endogenous plant EPSPS enzymes and is identical to the CP4 EPSPS 

in other commercially available Roundup Ready

®

crops, including Roundup Ready®soybean 

(40-3-2 and MON 89788), Roundup Ready®canola, Roundup Ready

®

sugar beet, Roundup 

Ready®flax, and Roundup Ready®cotton (USDA-APHIS, 2010c). The first generation of 

Roundup Ready®soybean (40-3-2) no longer subject to the regulatory requirements of 7 CFR 

part 340 or the plant pest provisions of the Plant Protection Act in 1995 (USDA-APHIS, 2010c). 

The cp4 epsps gene has been assessed extensively in the last 15 years. The safety of CP4 EPSPS 

protein present in biotechnology derived crops has been evaluated as part of comprehensive 

reviews of the safety of glyphosate exposure and ingestion (Harrison et al., 1996) (see also 

(Hammond et al., 1996; Padgette et al., 1996)). 

The CP4 EPSPS enzyme is likely to be expressed in MON 87769 containing varieties. FDA had

no further questions on Monsanto’s conclusion that their glyphosate-tolerant soybean with this 

enzyme, event MON 89788, when present in feeds and foods derived from this variety is not 

materially different in safety, composition, or any other relevant parameter from soybeans now 

grown, marketed, and consumed (see BNF 0104, January 19, 2007, 

http://www.fda.gov/Food/Biotechnology/Submissions/ucm155610.htm). 

The EPA has also reviewed the safety of the CP4 EPSPS protein and has established a tolerance 

exemption for the protein and the genetic material necessary for its production in or on all raw 

agricultural commodities ((US-EPA, 1996); 40 CFR §174.523). This exemption is based on a 

safety assessment that included rapid digestion in simulated gastric fluids, lack of homology to 

known toxins and allergens, and lack of toxicity in an acute oral mouse gavage study. The CP4 

EPSPS protein expressed in MON 87769 soybean is the same as that previously reviewed by the 

EPA. Accordingly, MON 87769 soybean is anticipated to be safe for human and animal 

consumption with regard to the cp4 epsps gene.

There are no significant impacts on human health related to the No Action Alternative or a 

determination of nonregulated status of MON 87769 soybean. Moreover, no cumulative effects 

have been identified by APHIS.

5.17 Cumulative Impacts: Animal Feed

No impacts were determined from APHIS’ analysis of possible impacts MON 87769 soybean on 

animal feed. However, Monsanto plans to market the MON 87769 soybean with the Roundup 

tolerance trait. The gene for the trait expresses the CP4 EPSPS protein, derived from 

Agrobacterium sp., to achieve glyphosate herbicide tolerance. The U.S. EPA has reviewed the 

safety of the CP4 EPSPS protein and has established a tolerance exemption for the protein and 

the genetic material necessary for its production in or on all raw agricultural commodities ((USEPA, 1996); 40 CFR §174.523). This exemption is based on a safety assessment that included 

rapid digestion in simulated gastric fluids, lack of homology to known toxins and allergens, and 

lack of toxicity in an acute oral mouse gavage study. The lack of any documented reports of 

adverse effects since the introduction of other Roundup Ready

®

crops in 1996 suggests the safety 

of its use.
108

There are no significant impacts on animal health related to the No Action Alternative or a 

determination of nonregulated status of MON 87769 soybean and no cumulative effects have 

been identified.

5.18 Cumulative Impacts: Domestic Economic Environment

MON 87769 soybean is intended to be cultivated as a specialty soybean product and its oil 

fraction will be produced and used within a closed loop stewardship system (Monsanto, 2010b). 

The likelihood that MON 87769 soybean will be stacked with an herbicide tolerance trait could 

potentially lead some IP producers to replace existing specialty soybean varieties to plant MON 

87769 soybean as a new specialty oilseed product. 

Agronomic and phenotypic analyses conducted by Monsanto did not demonstrate any substantial 

differences between MON 87769 soybean and conventional varieties. No new agronomic 

characteristics providing benefits for cultivation beyond traditional soybean cultivation regions 

were determined and none of the modifications expressed by MON 87769 soybean are 

considered likely to result in new acreage devoted to soybean cultivation outside of those regions 

where soybean is currently cultivated (Monsanto, 2010). The percentage of the U.S. soybean 

acreage dedicated to specialty oil soybeans does have the potential to change, contingent upon 

market acceptance and consumer demand, and specific applications of the specialty products. 

In the food supplements market, MON 87769 soybean has the potential to displace fish oils 

(containing stearidonic and higher level omega-3 fatty acids) and also some other non-soy oil 

crops that may produce SDA (Addendum 1, (Monsanto, 2010b)). The latter market derives from 

the likely small scale production of oils from Echium plantagineum, black currant (Ribes) and a 

few other plant sources of the fatty acid (Cyberlipid Center, 2011). In the foods production 

industry, the ability to provide SDA containing oils for large scale use in various manufactured 

foods, and baked products will likely expand business opportunities. These specifically will 

include supplementing existing oils used in functional foods and healthful products. 

For the past decade, soybean oil has consistently been the least expensive domestic vegetable oil

(Table 16) (USDA-ERS, 2011b) and the ability to produce a high value specialty fatty acid in 

soybean will keep production costs of the oil low. If MON 87769 soybean oil achieves market 

acceptance, the product has the potential to marginally displace other vegetable food oils, 

including other soybean, canola, or sunflower oils in certain specialized products, and then most 

likely as a supplement, and consequently may not completely replace other oils in existing 

formulations for those products. Given that a determination of nonregulated status of MON 

87769 soybean is not expected to lead to an expansion of U.S. soybean acreage or substantial 

changes in oil products industry, APHIS determines no significant impacts from production of 

MON 87769 soybean and no cumulative impacts.
109

Table 16. U.S. vegetable oil prices (dollars/gallon).

Marketing 

Year

Soybean 

Oil

Cottonseed 

Oil

Sunflower 

oil

Canola 

Oil

Peanut 

Oil Corn Oil

2000/01 1.09 1.23 1.22 1.35 2.69 1.04

2001/02 1.27 1.38 1.79 1.81 2.48 1.47

2002/03 1.70 2.91 2.55 2.29 3.60 2.17

2003/04 2.31 2.40 2.57 2.60 4.68 2.19

2004/05 1.77 2.16 3.37 2.37 4.13 2.15

2005/06 1.80 2.27 3.13 2.39 3.42 1.94

2006/07 2.39 1.98 4.47 3.12 4.08 2.45

2007/08 4.01 5.66 7.02 5.05 7.28 5.34

2008/09 2.48 2.09 3.87 3.04 6.04 2.52

2009/10 2.77 3.01 4.07 3.30 4.59 3.03

2010/11 4.27 4.46 5.92 4.77 6.31 4.65

Source: Table 9 (converted to dollars per gallon based on a vegetable oil conversion factor of 7.7 pounds per gallon) 

(USDA-ERS, 2011b).

5.19 Cumulative Impacts: Trade Economic Environment

Contingent upon producer and consumer acceptance, availability, and price, and considering that 

the market for MON 87769 soybean will be about 100,000 acres by 2016, this variety will 

occupy 0.5% of acreage planted to soybean in the affected area. Thus, there is insignificant 

potential to displace some of these comparable, non-soybean vegetable oils on the international 

market. Consistent with the analysis of international markets for GE soybean, a specialty oil for 

a small healthful products niche, and GE crops generally, APHIS has determined that there are 

no past, present, or reasonable foreseeable effects of the proposed action which would present a 

negative cumulative impact on the trade economic environment.

5.20 Cumulative Impacts: Social Environment

The planting and production of oils deriving from MON 87769 will not change the percentage of 

growers who plant specialty soybean products because the market for these products will likely

remain small for the next five years (Monsanto, 201l). No changes can be foreseen in the 

crusher/refiner businesses, since again, only those businesses which already crush small scale

specialty soybean will likely be signed up to accept the MON 87769 soybean. APHIS has 

determined that there are no past, present, or reasonably foreseeable actions that will aggregate 
110

with the effects of the proposed action to impact the social environment surrounding soybean 

farming.
111

6 THREATENED AND ENDANGERED SPECIES

The Endangered Species Act (ESA) of 1973, as amended, is one of the most far-reaching 

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 endangered and threatened species and the ecosystems on 

which they depend as key components of America’s heritage. To implement the ESA, the U.S. 

Fish & Wildlife Service (USFWS) works in cooperation with the National Marine Fisheries 

Service (NMFS), other Federal, State, and local agencies, Tribes, non-governmental 

organizations, and private citizens. 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 USFWS/NMFS to be endangered or 

threatened because of any of the following factors:

 The present or threatened destruction, modification, or curtailment of its habitat or range;

 Overutilization for commercial, recreational, scientific, or educational purposes;

 Disease or predation;

 The inadequacy of existing regulatory mechanisms; and

 The natural or manmade factors affecting its survival.

Once an animal or plant is added to the list, in accordance with the ESA, protective measures 

apply to the species and its habitat. These measures include protection from adverse effects of 

Federal activities. 

Section 7 (a)(2) of the ESA requires that Federal agencies, in consultation with USFWS and/or 

the NMFS, ensure that any action they authorize, fund, or carry out is not likely to jeopardize the 

continued existence of a listed species or result in the destruction or adverse modification of 

designated critical habitat. It is the responsibility of the Federal agency taking the action to 

assess the effects of their action and to consult with the USFWS and NMFS if it is determined 

that the action “may affect” listed species or critical habitat. To facilitate APHIS’ ESA 

consultation process, APHIS met with the USFWS from 1999 to 2003 to discuss factors relevant 

to APHIS’ regulatory authority and effects analysis for petitions for nonregulated status, and 

developed a process for conducting an effects determination consistent with the Plant Protection 

Act of 2000 (Title IV of Public Law 106-224). This process is described in a decision tree 

document, which is presented as appendix B. APHIS uses this process to help fulfill its 

obligations and responsibilities under Section 7 of the ESA for biotechnology regulatory actions. 

APHIS’ regulatory authority for GE organisms under the PPA is limited to those for which it has 

reason to believe might be a plant pest or those for which APHIS does not have sufficient 

information to determine that the GE organism is unlikely to pose a plant pest risk (7 CFR § 

340.1). After completing a plant pest risk analysis, APHIS concluded that MON 87769 soybean 

does not pose a plant pest risk (USDA-APHIS, 2010c). Because the agency has concluded that 

MON 87769 soybean is unlikely to pose a plant pest risk, a determination of nonregulated status 

of MON 87769 soybean 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 
112

Coordinated Framework. Nevertheless, APHIS has chosen to analyze the potential effects to 

threatened and endangered species and critical habitat under the ESA. As part the environmental 

review process, APHIS thoroughly reviews genetically engineered product information and data 

to inform the ESA effects analysis and, if necessary, the biological assessment related to the 

organism (generally a plant species, but may also be other genetically engineered organisms) for 

which regulatory jurisdiction applies under the plant pest provisions of the Plant Protection Act 

of 2000 and implementing regulations in 7 CFR part 340. For each transgene(s)/transgenic plant 

the following information, data, and questions are considered by APHIS: 

 A review of the biology and taxonomy 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 (TES) or a host of any TES.

In following this process, APHIS evaluated the potential effects that a determination of 

nonregulated status to MON 87769 soybean would have on Federally listed TES and species 

proposed for listing, as well as designated critical habitat and habitat proposed for designation

(See Appendix B). Based upon the scope of the EA and production areas identified in the 

Affected Environment section of the EA, APHIS obtained a list of TES species (listed and 

proposed) from the USFWS Environmental Conservation Online System (ECOS) for each state 

where MON 87769 soybean is likely to be commercially produced (ECOS; as accessed 

4/15/2011 at http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrence.jsp). 

As discussed above in the analysis of Gene Movement and Weediness and Plants, APHIS has 

determined that there is no risk to unrelated plant species from the cultivation of MON 87769 

soybean. Monsanto submitted results of a comparison of agronomic and phenotypic differences 

between MON 87769 soybean and conventional soybean; there is no reason to believe that MON 

87769 soybean is different from the commercial variety from which it was developed (USDAAPHIS, 2010c). Consistent with these studies, APHIS has concluded the determination of 

nonregulated status of MON 87769 soybean does not present a plant pest risk, does not present a 

risk of weediness, and does not present an increased risk of gene flow when compared to other 

currently cultivated varieties. 

Accordingly, APHIS focuses our assessment of possible impacts on TES animal species, 

particularly those potentially at risk from the consumption of MON 87769 soybean. Few TES 

animal species are likely to frequent soybean fields because the habitat would not be suitable. 

Some animal species, particularly migratory birds, may visit soybean fields, but their presence 

would be a passing one as the habitat is either not suitable or does not contain constituent 

elements required by the species. It is reasonable to assume that populations of the species 
113

adjacent to soybean production fields could be impacted by aspects of cultivation of MON 87769 

soybean or could feed on MON 87769 soybean. As described below, the EPA and the FDA have 

conducted independent evaluations of these potential risks directly relevant to APHIS’ analysis.

Monsanto measured compositional aspects of MON 87769 soybean and compared these data 

with conventional soybean. The intended expression of SDA and also of gamma linolenic acid is 

new to commodity soybean. Although the animal feed consultation with FDA is pending, 

submitted data showed that these new components are both intermediates in mammalian systems 

during production of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), and also 

are found in the environment in numerous other plant and animal sources. Linoleic acid (18:2) is 

decreased to about 41% of control percentage, and this altered soybean content is similar to that 

of canola oil. Statistically significant but small differences were observed in the comparisons of 

the A3525 conventional variety to MON 87769 soybean in the concentrations of several fatty 

acids (16:0 palmitic, 18:0 stearic, 18:1 oleic, 18:3 alpha linolenic acid, 20:0 arachidic, 22:0 

behenic). APHIS evaluated these differences in composition, and has determined that those 

reported for MON 87769 either fall within the typical commercial range for percentage 

composition, or within the 99% tolerance interval for soybean composition (Monsanto, 2010b). 

For several amino acids % of total amino acid content, % dry weight of proximates (protein and 

carbohydrate) and two isoflavones were also different from controls (US-EPA, 1993b), but these 

also were within either the range of commercial values or the 99% tolerance level for 

commercial soybean (Monsanto, 2010b). 

Because the composition of MON 87769 soybean is either similar to other commercial soybean 

plants in most constituents, or expresses fatty acids that are unlikely to impact human or animal 

health with consumption, it is unlikely that MON 87769 soybean poses a hazard to TES animal 

species. Because no hazards are identified, the risk of MON 87769 soybean affecting TES 

animal species is also unlikely, regardless of exposure.

Based on the above information, APHIS has determined that the Preferred Alternative, a 

determination of nonregulated status of MON 87769 soybean, would have no effect on Federally

listed TES proposed for listing, or on designated critical habitat or habitat proposed for 

designation. Following the BRS Decision Tree Document that indicates when a consultation 

with FWS is triggered (See Appendix B), APHIS BRS has determined that a written concurrence 

or formal consultation with the USFWS is not required for this action.

6.1 Cumulative Impacts of Stacking MON 87769 Soybean with a Glyphosate Tolerant 

Trait on TES

Monsanto has stated that MON 87769 soybean will likely be conventionally bred with the cp4 

epsps gene (glyphosate tolerance trait), and as a result, APHIS has decided to conduct a 

cumulative NEPA impact analysis of this potential future action on TES. 

The U.S. EPA has published an exemption from tolerance for the cp4 epsps gene and the 

material necessary for its production in all plants (US-EPA, 1996). Roundup Ready® crops 

incorporating the cp4 epsps gene have been marketed since the mid-1990s with no reports of any

non-target impacts associated with exposure to or consumption of the modified crop. 

Accordingly, no impacts to TES are anticipated as a result of exposure to the cp4 epsps gene. 
114

The U.S. EPA has conducted a review of the potential impacts of glyphosate to non-target 

species, and has determined that when used in accordance with the FIFRA label, the potential 

impacts to non-target species is not significant (US-EPA, 1993a, 1993b). As the action agency

for pesticide registrations, U.S. EPA has the responsibility to conduct an assessment of effects of 

a registration action on TES. The U.S. EPA Endangered Species Protection Program web site, 

http://www.epa.gov/espp/, describes the U.S. EPA assessment process for endangered species. 

Some of the elements of that process, generally taken from the web site, are summarized below.

When registering a pesticide or reassessing the potential ecological risks from use of a currently 

registered pesticide, U.S. EPA evaluates extensive exposure and ecological effects data to 

determine how a pesticide will move through and break down in the environment. Risks to 

birds, fish, invertebrates, mammals and plants are routinely assessed and used in U.S. EPA’s 

determinations of whether a pesticide may be licensed for use in the U.S. 

U.S. EPA’s core pesticide risk assessment and regulatory processes ensure that protections are in 

place for all populations of nontarget species, including TES. These assessments provide U.S. 

EPA with information needed to develop label use restrictions for the pesticide. These label 

restrictions carry the weight of law and are enforced by U.S. EPA and the states (Federal 

Insecticide, Fungicide, and Rodenticide Act 7 USC §136j (a)(2)(G) Unlawful acts). Because 

TES may need specific protection, U.S. EPA has developed risk assessment procedures, 

described in the Overview of the Ecological Risk Assessment Process (US-EPA, 2004), to 

determine whether individuals of a listed species have the potential to be harmed by a pesticide; 

and if so, what specific protections may be appropriate. U.S. EPA’s conclusion regarding the 

potential risks a pesticide may pose to a listed species and any designated critical habitat for the 

species, after conducting a thorough ecological risk assessment, results in an "effects 

determination" in accordance with Section 7 (a)(2) of the ESA.

As a part of U.S. EPA’s TES effects assessment for the California red-legged frog (US-EPA, 

2008), U.S. EPA evaluated the effect of glyphosate use at rates up to 7.95 pounds active 

ingredient per acre (lb a.i./A) on fish, amphibians, aquatic invertebrates, aquatic plants, birds, 

mammals, and terrestrial invertebrates. The U.S. EPA assessment was uncertain of the effects on 

terrestrial invertebrates, citing the potential to affect small insects at all application rates and 

large insects at the higher application rates. 

U.S. EPA considered these potential effects as part of their review process and label use 

restrictions for glyphosate tolerant crops imposed under authority of FIFRA. U.S. EPA has 

imposed specific label use restrictions for glyphosate use when applied with aerial equipment 

including “The product should only be applied when the potential for drift to adjacent sensitive 

areas (e.g., residential areas, bodies of water, known habitat for threatened or endangered 

species, non-target crops) is minimal (e.g., when wind is blowing away from the sensitive 

areas).” This requirement should protect TES that may be at risk from exposure to glyphosate.

To facilitate pesticide applicator adherence to U.S. EPA label use restrictions for glyphosate, 

Monsanto has designed a web-based program (www.Pre-Serve.org), designed to ensure no effect 

of glyphosate applications on threatened and endangered plant species. Pre-Serve instructs 

growers to observe specific precautions including buffer zones when spraying glyphosate 

herbicides on glyphosate-tolerant crops near threatened and endangered plant species that may be 
115

at risk. In addition, label requirements for Monsanto’s Roundup® formulations and glyphosate 

formulations marketed by other manufacturers prohibit application in conditions or locations 

where adverse impact on federally designated endangered/threatened plants or aquatic species is 

likely.

In conclusion, there are legal precautions in place (U.S. EPA label use restrictions) and “best 

practice” guidance to reduce the possibility of exposure and adverse impacts to TES from 

glyphosate application. U.S. EPA has considered potential impacts to TES as part of their 

registration and labeling process for glyphosate; and adherence to U.S. EPA label use restrictions 

by the pesticide applicator will ensure that the use of glyphosate will not adversely affect TES or 

critical habitat. Furthermore, pesticide applicators are legally required to follow U.S. EPA label 

use restrictions. 

Finally, cultivation of MON 87769 soybean is not expected to result in an increase in the 

application of glyphosate or changes of any other herbicide treatments when compared with 

existing herbicide-tolerant and non-GE soybean varieties. APHIS has determined that there are 

no past, present, or reasonably foreseeable actions that would aggregate with effects of the 

proposed action on TES.
116

7 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AN D 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, 2010a), "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.

Each alternative was 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.

Based on the information submitted by the applicant and assessed by APHIS, MON 87769 

soybean is agronomically, phenotypically, and biochemically comparable to conventional 

soybean except for the intended unique fatty acid profile (i.e., the presence of SDA and GLA). 

The information provided in the petition indicates that the two desaturase proteins, PjD6D and 

NcFad3, expressed in MON 87769 soybean are not expected to be allergenic, toxic, or 

pathogenic in mammals (Monsanto, 2010b). Also, FDA indicated that they had no questions 

“regarding Monsanto’s conclusion that SDA soybean oil is GRAS under the intended conditions 

of use” (US-FDA, 2009a). The use of SDA soybean oil in selected food categories could provide 

a wide range of dietary alternatives for increasing human intake of omega-3 fatty acid. The oil 

derived from MON 87769 soybean, is intended for use only in certain markets and will be 

identity preserved to maintain its value and assure its use in appropriate food applications. 

Additionally, the defatted soybean meal from MON 87769 soybean is compositionally similar to 

other defatted commodity soybean meal and will be used in a manner similar to the meal derived 

from these commodity soybean. This information establishes the safety of MON 87769 soybean 

and its products to humans, including minorities and low income populations who might be 

exposed to them through agricultural production and/or processing. No additional safety

precautions would need to be taken. 
117

None of the impacts on agricultural practices expected to be associated with a determination of 

nonregulated status of MON 87769 soybean are expected to have a disproportionate adverse 

effect on minorities and low income populations. MON 87769 soybean is not genetically 

engineered to produce a toxin or pesticide, and is not genetically engineered to be tolerant to 

an herbicide. Due to the lack of pesticidal and herbicidal traits in MON 87460 Soybean, 

soybean hybrid varieties may be produced with MON 87769 soybean and other nonregulated 

soybean hybrids containing herbicide tolerant traits. Thus, pesticide application practices and 

usage associated with a determination of nonregulated status of MON 87769 soybean are not 

expected to change from the current trends for existing nonregulated GE soybean.

The following executive order addresses Federal responsibilities regarding the introduction and 

effects of invasive species:

EO 1311 (US-NARA, 2010b), “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. 

Non-GE soybean, as well as other modified fatty acid soybean varieties, are widely grown in the 

U.S. Based on the historical experience with these varieties and the data submitted by the 

applicant and reviewed by APHIS, MON 87769 soybean are sufficiently similar in fitness 

characteristics to other soybean varieties currently grown and are not expected to become weedy 

or invasive (USDA-APHIS, 2010c). 

The following executive order requires the protection of migratory bird populations:

EO 13186 (US-NARA, 2010b), “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. 

Monsanto has presented results of field trials conducted to evaluate field phenotypic, 

agronomic and environmental interactions. These data, presented in Appendix G of the 

petition (USDA-APHIS, 2010c), showed no differences in arthropod damage or arthropod 

pest and beneficial insect abundance between MON 87769 soybean and other varieties, 

supporting the conclusion that the modified oil trait is unlikely to impact food sources for 

migratory bird species. Migratory bird use of soybean in harvested fields is reduced in 

terms of species numbers as well as population densities compared to their use of corn and 

sunflower fields (Galle et al., 2009), so usefulness of soybean for these birds may be as only 

a secondary source of grain. 

Migratory birds may forage on soybean seed before seed germination in a field that produced 

soybean the previous growing season, and following harvest, may also ingest additional seed. 

Data submitted by the applicant has shown no difference in compositional and nutritional 

quality of MON 87769 soybean compared to commercial soybean or non-GE-soybean, apart 
118

from the modification of the fatty acid composition. Fatty acid content is unlikely to impact 

bird species, since the oils derived from MON 87769 are both typical of other seeds and have 

been approved for GRAS status. Based on APHIS’ assessment of MON 87769 soybean, it is 

unlikely that a determination of nonregulated status of MON 87769 soybean will have a 

negative effect on migratory bird populations that occasionally forage in soybean fields. 

International Implications

EO 12114 (US-NARA, 2010b), “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 87769. 

All existing national and international regulatory authorities and phytosanitary regimes that 

currently apply to introductions of new soybean cultivars internationally apply equally to those 

covered by an APHIS determination of nonregulated status under 7 CFR part 340. 

Any international trade of MON 87769 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 developed under the International Plant Protection Convention 

(IPPC, 2010). The purpose of the IPPC “is to secure a common and effective action to prevent 

the spread and introduction of pests of plants and plant products and to promote appropriate 

measures for their control” (IPPC, 2010). The protection it affords extends to natural flora and 

plant products and includes both direct and indirect damage by pests, including weeds. 

The IPPC establishes a standard for the reciprocal acceptance of phytosanitary certification 

among the nations that have signed or acceded to the Convention (172 countries as of March 

2010). In April 2004, a standard for PRA of living modified organisms (LMOs) was adopted at 

a meeting of the governing body of the IPPC as a supplement to an existing standard, 

International Standard for Phytosanitary Measure 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 genetically engineered 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 
119

consent from the importing country under an advanced informed agreement (AIA) provision, 

which includes a requirement for a risk assessment consistent with Annex III of the Protocol and 

the required documentation.

LMOs imported for food, feed, or processing (FFP) are exempt from the AIA procedure, and are 

covered under Article 11 and Annex II of the Protocol. Under Article 11, Parties must post 

decisions to the Biosafety Clearinghouse database on domestic use of LMOs for FFP that may be 

subject to transboundary movement. To facilitate compliance with obligations to this protocol, 

the U.S. Government has developed a website that provides the status of all regulatory reviews 

completed for different uses of bioengineered products (NBII, 2010). These data will be 

available to the Biosafety Clearinghouse. 

APHIS continues to work toward harmonization of biosafety and biotechnology consensus 

documents, guidelines, and regulations, including within the North American Plant Protection 

Organization (NAPPO), which includes Mexico, Canada, and the U.S., and within the 

Organization for Economic Cooperation and Development (OECD). NAPPO has completed 

three modules of the Regional Standards for Phytosanitary Measures (RSPM) No. 14, 

Importation and Release into the Environment of Transgenic Plants in NAPPO Member 

Countries (NAPPO, 2009).

APHIS also participates in the North American Biotechnology Initiative (NABI), a forum for 

information exchange and cooperation on agricultural biotechnology issues for the U.S., Mexico, 

and Canada. In addition, bilateral discussions on biotechnology regulatory issues are held 

regularly with other countries including Argentina, Brazil, Japan, China, and Korea.

7.2 Compliance with Clean Water Act and Clean Air Act

This EA evaluated the changes in soybean production due to a determination of 

nonregulated status of MON 87769 soybean. Cultivation of MON 87769 soybean will not 

lead to the increased production of soybean in U.S. agriculture. 

There is no expected change in water use due to the cultivation of MON 87769 soybean

compared to current soybean seed and production regimes. There is no expected change in 

air quality associated with agronomic practices associated with the cultivation of MON 

87769 soybean.

Based on this review, APHIS concludes that the cultivation of MON 87769 soybean would 

inherently comply with the Clean Water Act and the Clean Air Act.

7.3 Impacts on Unique Characteristics of Geographic Areas

A determination of non-regulated status of MON 87769 soybean is not expected to adversely 

impact unique characteristics of geographic areas such as park lands, prime farm lands, wetlands, 

wild and scenic areas, or ecologically critical areas. 

The common agricultural practices that would be carried out in the cultivation of MON 87769 

soybean are not expected to deviate from current practices. The product will be deployed on 
120

agricultural land currently suitable for production of soybean, will replace existing varieties, and 

is not expected to increase the acreage of soybean production. 

There are no proposed major ground disturbances; no new physical destruction or damage to 

property; no alterations of property, wildlife habitat, or landscapes; and no prescribed sale, lease, 

or transfer of ownership of any property. This action is limited to a determination of nonregulated status of MON 87769 soybean. This action would not convert land use to 

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

agricultural practices for land preparation, planting, irrigation, and harvesting of plants would be 

used on agricultural lands planted to MON 87769 soybean including the use of EPA registered 

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

potential impacts to the human environment.

7.4 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 and 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. 

A determination of nonregulated status of MON 87769 soybean 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.

A determination of nonregulated status of MON 87769 soybean would have no impact on 

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

Register of Historic Places, nor would 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 87769. 

A determination of nonregulated status of MON 87769 soybean 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. Additionally, these cultivation 

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

cultivation of MON 87769 soybean does not inherently change any of these agronomic practices 

so as to give rise to an impact under the NHPA.
121

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146

9 APPENDIX A: FDA SUSBSTANCES GENERALLY RECOGNIZED AS SAFE 

(GRAS) – AGENCY RESPONSE LETTER GRAS NOTICE NO. GRN 000283

Agency Response Letter GRAS Notice No. GRN 000283

CFSAN/Office of Food Additive Safety

September 4, 2009

Raymond C. Dobert, Ph.D.

Monsanto Company

800 North Lindbergh Blvd

St. Louis, MO 63167

Re: GRAS Notice No. GRN 000283

Dear Dr. Dobert:

The Food and Drug Administration (FDA) is responding to the notice, dated February 25, 2009, 

that you submitted in accordance with the agency’s proposed regulation, proposed 21 CFR 

170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS 

proposal). FDA received the notice on February 26, 2009, filed it on March 3, 2009, and 

designated it as GRAS Notice No. GRN 000283.

The subject of the notice is stearidonic acid (SDA) soybean oil. The notice informs FDA of the 

view of Monsanto Company (Monsanto) that SDA soybean oil is GRAS, through scientific 

procedures, for use as an ingredient in baked goods and baking mixes, breakfast cereals and 

grains, cheeses, dairy product analogs, fats and oils, fish products, frozen dairy desserts and 

mixes, grain products and pastas, gravies and sauces, meat products, milk products, nuts and 

nut products, poultry products, processed fruit juices, processed vegetable products, puddings 

and fillings, snack foods, soft candy, and soups and soup mixes, at levels that will provide 375 

milligrams (mg) of SDA per serving.1

21 CFR 101.4 states that all ingredients must be declared by their common or usual name. In 

addition, 21 CFR 102.5 outlines general principles to use when establishing common or usual 

names for nonstandardized foods. Our use of “SDA soybean oil” in this letter should not be 

considered an endorsement or recommendation of that term as an appropriate common or 

usual name for the purpose of declaring the substance in the ingredient statement of foods 

that contain that ingredient. Issues associated with labeling and the appropriate common or 

usual name of a food are the responsibility of the Office of Nutrition, Labeling, and Dietary 

Supplements (ONLDS) in the Center for Food Safety and Applied Nutrition.

As part of its notice, Monsanto includes the report of a panel of individuals (Monsanto’s GRAS 

panel) who evaluated the data and information that are the basis for Monsanto’s GRAS 
147

determination. Monsanto considers the members of its GRAS panel to be qualified by scientific 

training and experience to evaluate the safety of substances added to food. Monsanto’s GRAS 

panel evaluated estimates of dietary exposure, method of production, and product 

specifications. as well as published studies. Based on this review, Monsanto’s GRAS panel 

concluded that SDA soybean oil that meets its established food grade specifications is GRAS 

under the conditions of its intended use.

Monsanto describes the identity of SDA soybean oil. The oil is obtained from a bioengineered 

soybean. Monsanto states that SDA soybean oil is compositionally different from conventional 

soybean oil. SDA soybean oil contains 15 to 30 percent SDA and 5 to 8 percent gamma-linolenic 

acid (GLA), neither of which is present in conventional soybean oil. SDA soybean oil also 

contains slightly higher levels of alpha-linolenic acid (ALA) and palmitic acid than conventional 

soybean oil. SDA soybean oil contains lower levels of oleic acid and linoleic acid (LA) than those 

present in conventional soybean oil. Monsanto notes that the variability in the oil’s fatty acid 

composition, notably the SDA concentration, is due to natural variation in growing conditions 

for the soybean.

Monsanto discusses the biosynthetic pathway of SDA in the bioengineered soybean. SDA 

biosynthesis involves the introduction of two desaturase genes that encode for the proteins 

Primula juliae delta 6-desaturase and Neurospora crassa delta 15-desaturase. Conventional 

soybeans lack delta 6-desaturase; delta 6-desaturase is required for the production of SDA in 

soybeans. Addition of the delta 15-desaturase with temporal expression similar to the delta 6-

desaturase increases the flux of ALA to SDA. The delta 15-desaturase also lowers LA levels, thus 

lowering the substrate pool for GLA production. Monsanto notes that the introduced 

desaturases are the only non-soybean genes expressed in the bioengineered soybean.2

SDA soybean oil is processed using conventional industry standard processing methods. The 

soybean meat is first mechanically separated from the hulls. The resulting soybean meat is then 

flaked and solvent extracted with iso-hexane/hexane to yield crude soybean oil and soybean 

meal. The crude oil is degummed and bleached, and further purified through filtration and 

steam distillation. Anti-oxidants, primarily TBHQ, are added at the end of processing to inhibit 

oxidation of the oil. All processing aids used in the manufacture of SDA soybean oil are used in 

compliance with appropriate federal regulations.

Monsanto states that stability of SDA soybean oil was determined with respect to peroxide 

value and fatty acid content. SDA soybean oil maintains a peroxide value similar to that of 

conventional soybean oil under similar storage conditions. Monsanto notes that SDA oil is 

stable when stored under nitrogen, as is typical for soybean oil, for as long as nine months.

Monsanto provides specifications for SDA soybean oil with comparison to the specifications set 

forth in the Food Chemicals Codex (FCC), 6th Edition, for conventional soybean oil. Specifications 

include fatty acid composition, stability, limits for free fatty acids (< 0.1 percent), lead (< 0.1 

milligrams/kilogram), peroxide value (< 10 milliequivalents/kilogram), unsaponifiable matter (< 

1.5 percent), and water (< 0.1 percent).

Monsanto estimates the per capita consumption of SDA soybean oil from all intended food uses 

using the intended use levels in conjunction with food consumption data included in the 
148

National Health and Nutrition Examination Surveys (1999-2002). The current intake of fat, 

trans-fat, and fatty acids in the diet as well as intake following the addition of 20 or 30 percent 

SDA soybean oil to the intended food uses was calculated. SDA soybean oil was either added to 

foods or used as a replacement for unhydrogenated oil (including soybean oil, ‘not further 

specified’ oil, corn oil, cottonseed oil, peanut oil, sunflower oil, coconut oil, olive oil, canola oil, 

or palm oil). Monsanto notes that in order to achieve 375 milligrams SDA per serving of food, 

target foods need to have 1.8 g of 20 percent SDA soybean oil or 1.3 grams of 30 percent SDA 

soybean oil per serving of food.

Monsanto estimates, on a per capita basis, mean and 90th percentile intakes of 20 percent SDA 

soybean oil to be 10.1 and 19.6 grams per day (g/day), respectively (0.18 and 0.38 grams per 

kilogram body weight per day (g/kg bw/day), respectively). Monsanto also estimates per capita

mean and 90th percentile intakes of 30 percent SDA soybean oil to be 7.6 and 14.8 g/day, 

respectively (0.10 and 0.30 g/kg bw/day, respectively). Monsanto estimates the per capita

mean and 90th percentile intakes of SDA to be 2.1 g/day and 4.1 g/day, respectively. Estimated 

intakes of SDA were similar for 20 or 30 percent SDA soybean oil due to the constant use level 

of SDA per serving.

Monsanto discusses the known biochemical pathways through which SDA soybean oil is 

metabolized after absorption into the body. The fatty acids (FA) of SDA soybean oil may 

undergo beta-oxidation to produce acetyl-CoA, or they may be elongated to form long chain 

fatty acids such as eicosapentaenoic acid (EPA). Monsanto describes published studies that 

discuss the FA elongation conversion rate in humans as being as high as 3:1 SDA to EPA; this 

equates to 0.73 g/day at the mean, and 1.4 g/day at the 90th percentile for the intended food 

uses.

Monsanto discusses published animal studies for SDA soybean oil, in which rats received up to 

4 g/kg bw/day; no toxicologically significant effects were observed. Monsanto also cites other 

published animal studies where rats, guinea pigs, and dogs consumed SDA oil derived from 

sources other than soybean at up to 2.1 g/kg bw/day with no toxicologically significant effects 

observed. In addition, no reproductive or developmental effects were seen in a published study 

in which rats received up to 4 g/kg bw/day. Furthermore, Monsanto describes a published 

study in humans where SDA soybean oil, consumed at 3.66 g/d for 16 weeks, did not affect 

physiological or blood chemistry endpoints. Other published studies in which humans 

consumed SDA oil derived from non-soybean sources, showed no adverse effects at levels up to 

1.875 g/day.

Standards of Identity

In the notice, Monsanto states its intention to use SDA soybean oil in several food categories, 

including foods for which standards of identity exist, located in Title 21 of the Code of Federal 

Regulations. We note that an ingredient that is lawfully added to food products may be used in 

a standardized food only if it is permitted by the applicable standard of identity.

Potential Labeling Issues
149

Under section 403(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA), a food is 

misbranded if its labeling is false or misleading in any particular. Section 403(r) of the FFDCA 

lays out the statutory framework for the use of labeling claims that characterize the level of a 

nutrient in a food or that characterize the relationship of a nutrient to a disease or healthrelated condition. In describing the intended use of SDA soybean oil and in describing the 

information that Monsanto relies on to conclude that SDA soybean oil is GRAS under the 

conditions of its intended use, Monsanto raises a potential issue under these labeling provisions 

of the FFDCA. If products that contain SDA soybean oil bear any claims on the label or in 

labeling, such claims are the purview of ONLDS. The Office of Food Additive Safety neither 

consulted with ONLDS on this labeling issue nor evaluated the information in your notice to 

determine whether it would support any claims made about SDA soybean oil on the label or in 

labeling.

Allergen Labeling

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) amends the FFDCA 

to require that the label of a food that is or contains an ingredient that bears or contains a 

“major food allergen” declare the presence of the allergen (section 403(w)). FALCPA defines a 

“major food allergen” as one of eight foods or food groups (i.e., milk, eggs, fish, Crustacean 

shellfish, tree nuts, peanuts, wheat, and soybeans) or a food ingredient that contains protein 

derived from one of those foods. Issues associated with labeling food are the responsibility of 

ONLDS.

Use in Meat, Poultry, and Egg Products

During its evaluation of GRN 000283, FDA consulted with the Risk and Innovations 

Management Division of the Food Safety and Inspection Service (FSIS) of the United States 

Department of Agriculture. Under the Federal Meat Inspection Act, the Poultry Products 

Inspection Act, and the Egg Products Inspection Act, FSIS is responsible for determining the 

efficacy and suitability of food ingredients in meat, poultry, and egg products as well as 

prescribing safe conditions of use. Suitability relates to the effectiveness of the ingredient in 

performing the intended purpose of use and the assurance that the conditions of use will not 

result in an adulterated product, or one that misleads consumers.

FSIS requested that FDA advise Monsanto to seek regulatory guidance from FSIS about the use 

of SDA soybean oil in meat and poultry products. Monsanto should direct such an inquiry to Dr. 

John M. Hicks, Jr., Risk and Innovations Management Division, Office of Policy and Program 

Development, Food Safety and Inspection Service, United States Department of Agriculture, 

George Washington Carver Center (GWCC), 5601 Sunnyside Ave., Mailstop 5271, Beltsville, MD 

20705-5271. The telephone number for that office is (391) 504-0884 and the telefax number is 

(301) 504-0876.

Section 301(ll) of the FFDCA

The Food and Drug Administration Amendments Act of 2007, which was signed into law on 

September 27, 2007, amends the FFDCA to, among other things, add section 301(ll). Section 

301(ll) of the FFDCA prohibits the introduction or delivery for introduction into interstate 
150

commerce of any food that contains a drug approved under section 505 of the FFDCA, a 

biological product licensed under section 351 of the Public Health Service Act, or a drug or a 

biological product for which substantial clinical investigations have been instituted and their 

existence made public, unless one of the exemptions in section 301(ll)(1)-(4) applies. In its 

review of Monsanto’s notice that SDA soybean oil is GRAS for use in certain foods, FDA did not 

consider whether section 301(ll) or any of its exemptions apply to foods containing SDA 

soybean oil. Accordingly, this response should not be construed to be a statement that foods 

that contain SDA soybean oil, if introduced or delivered for introduction into interstate 

commerce, would not violate section 301(ll).

Conclusions

Based on the information provided by Monsanto, the agency has no questions at this time 

regarding Monsanto’s conclusion that SDA soybean oil is GRAS under the intended conditions 

of use. The agency has not, however, made its own determination regarding the GRAS status of 

the subject use of SDA soybean oil. As always, it is the continuing responsibility of Monsanto to 

ensure that food ingredients that the firm markets are safe, and are otherwise in compliance 

with all applicable legal and regulatory requirements.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to 

GRN 000283, as well as a copy of the information in this notice that conforms to the 

information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public 

review and copying via the FDA home page at http://www.fda.gov. To view or obtain an 

electronic copy of the text of the letter, follow the hyperlinks from the “Food” topic to the 

“Food Ingredients and Packaging” section to the “Generally Recognized as Safe (GRAS)” page 

where the GRAS Inventory is listed.

Sincerely,

Mitchell A. Cheeseman, Ph.D.

Acting Director

Office of Food Additive Safety

Center for Food Safety and Applied Nutrition

cc: John M. Hicks, Jr. DVM, MPH

Risk and Innovations Management Division

Office of Policy and Program Development

Food Safety and Inspection Service

United States Department of Agriculture

George Washington Carver Center (GWCC)

5601 Sunnyside Ave., Mailstop 5271

Beltsville, MD 20705-5271
151

1Reference amounts customarily consumed (21 CFR 101.12)

2Monsanto states that Neurospora crassa is considered a non-pathogenic organism and is found 

in foods worldwide. Monsanto also notes that Primula juliae is a member of the Primula

(Primrose) genus that includes plants that are commonly used as sources of GLA for human 

uses.
152

10 APPENDIX B: APHIS THREATENED AND ENDANGERED SPECIES DECISION 

TREE FOR FWS CONSULTATIONS

DECISION TREE ON WHETHER SECTION 7 CONSULTATIONS WITH 

FWS IS TRIGGERED FOR PETITIONS OF TRANSGENIC PLANTS

This decision tree document is based on the phenotypes (traits) that have been field tested under 

APHIS oversight (for a list of approved field tests, visit Information Systems for Biotechnology.) 

APHIS will re-evaluate and update this decision document as it receives new applications for 

field testing of new traits that are genetically engineered into plants.

BACKGROUND

For each transgene(s)/transgenic plant the following information, data, and questions will be 

addressed by APHIS, and the EAs on each petition will be publicly available. APHIS review 

will encompass: 

 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),

 Analysis to determine if the transgenic plant is sexually compatible with any threatened 

or endangered plant species (TES) or a host of any TES.

FDA published a policy in 1992 on foods derived from new plant varieties, including those 

derived from transgenic plants (http://vm.cfsan.fda.gov/~lrd/fr92529b.html and 

http://vm.cfsan.fda.gov/~lrd/consulpr.html). The FDA’s policy requires that genetically 

engineered foods meet the same rigorous safety standards as is 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 human and thus do not require 

pre-market approval. Consistent with its 1992 policy, FDA expects developers to consult with 

the agency on safety and regulatory questions. A list of consultations is available at 

http://vm.cfsan.fda.gov/~lrd/biocon.htmlhttp://vm.cfsan.fda.gov/~lrd/biocon.html. APHIS 

considers the status and conclusion of the FDA consultations in its EAs.
153

Below is a description of our review process to whether a consultation with U.S. Fish and 

Wildlife Service is necessary. 

If the answer to any of the questions 1-4 below is yes, APHIS will contact FWS to determine if 

a consultation is required:

1) Is the transgenic plant sexually compatible with a TE plant2 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 

toxins3)?

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 agro-ecosystem)4? 

5) Does the pest resistance5gene act by one of the mechanisms listed below? If the answer is 

YES then a consultation with U.S. Fish and Wildlife Service is NOT necessary.

A. The transgene acts only in one or more of the following ways: 

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); 

In the plant by inactivating or resisting toxins or other disease causing substances 

produced by the pest; 

By creating a deficiency in the host of a component required for growth of the pest (such 

as with fungi and bacteria); 

 

2

APHIS will provide FWS a draft EA that will address the impacts, if any, of gene movement to the TES plant.

3

Via a comparison of the amino acid sequence of the transgene’s protein with those found in the protein databases 

like PIR, Swiss-Prot and HIV amino acid data bases.

4

Such phenotypes might include tolerance to environmental stresses such as drought, salt, frost, aluminum or heavy 

metals.

5

Pest resistance would include any toxin or allelochemical that prevents, destroys, repels or mitigates a pest or 

effects any vertebrate or invertebrate animal, plant, or microorganism.
154

By initiating, enhancing, or potentiating the endogenous host hypersensitive disease 

resistance response found in the plant; 

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. 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 Fish and 

Wildlife Service is not required for this EA.

________ 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 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 non-regulated status is likely to affect adversely one or more 

listed threatened or endangered species and has initiated a formal consultation with the Fish and 

Wildlife Service.
155

11 APPENDIX C: PETITION FOR THE DETERMINATION OF NONREGULATED 

STATUS FOR MON 87769 – ADDENDUM: POTENTIAL MARKET IMPACT OF 

MON 87769
156

Petition for the Determination of Nonregulated Status for 

MON 87769

ADDENDUM 

Potential Market Impact of MON 87769 

Submitted July 1st, 2011

OECD Unique Identifier: MON-87769-7

Monsanto Petition Number: 09-183-01p
157

Introduction

Monsanto has developed biotechnology-derived soybean MON 87769 (SDA soybean) that 

contains stearidonic acid (SDA), a sustainable alternate source of an omega-3 fatty acid to help 

meet the need for increased dietary intake of long chain omega-3 fatty acids. In mammals, SDA 

is a metabolic intermediate in the production of eicosapentaenoic acid (EPA) and 

docosahexaenoic acid (DHA) from alpha linolenic acid (ALA), a common dietary constituent. 

Refined oil produced from MON 87769 contains approximately 20 to 30% SDA (wt% of total 

fatty acids) and can be included in a range of food products for health benefits. The oil from 

MON 87769 (SDA soybean oil) is Generally Recognized As Safe (GRAS) in the United States 

and can be used for the production of products such as margarine, shortenings, salad dressings, 

ready-to-eat foods, and other food categories specified in the GRAS notification6. 

MON 87769 is a specialty trait soybean, not developed for the commodity soybean market, and 

it is anticipated that MON 87769 will be a low acreage product planned initially for production 

in North America. In bringing this product to market, Monsanto will adhere to the 

Biotechnology Industry Organization’s (BIO’s) Product Launch Stewardship policy7, including

its Annex 2: “Specialty Use Traits in Commodity Crops.” 

Market and Trade Assessment:

Monsanto has evaluated the potential impacts from the introduction of MON 87769 into the 

marketplace. This assessment which is hereafter referred to as ‘market and trade assessment’ has 

taken into consideration the potential impacts which could be anticipated within the value chain 

due to the introduction of SDA soybean. The defatted soybean meal from MON 87769 is 

compositionally similar to other commodity defatted soybean meal and will be used in a manner 

similar to commodity soybean meal. The oil derived from MON 87769, however, has a unique 

fatty acid profile and will be identity preserved to maintain its value and assure its use in 

appropriate food applications. Compared to commodity soybean oil, SDA soybean oil contains 

two additional fatty acids, SDA and GLA. SDA soybean oil is intended for use only in certain 

markets. The presence of this oil in markets where it is not intended could result in potential 

market and trade impacts.

At the time SDA soybean oil is first introduced to the market, we do not expect that MON 87769 

will have approvals in all key soybean export markets with functioning regulatory systems. 

Until such approvals are received, MON 87769 will be grown and handled in a closed loop 

stewardship system (CLSS).

 

6

http://www.accessdata.fda.gov/scripts/fcn/gras_notices/grn000283.pdf

7

http://www.bio.org/letters/Product_Launch_Stewarship_12_10_09.pdf
158

Monsanto will utilize and implement the CLSS throughout the initial product introduction phase, 

at least until approvals are received from key soybean export countries with functioning 

regulatory systems. After such approvals are received, Monsanto will, based on the experiences 

and learning gained during the initial product introduction phase under the CLSS, refine and 

update the stewardship system for long-term implementation. This long-term system will 

include measures to preserve the identity of this high value product and mitigation measures to 

minimize any impact resulting from the inadvertent comingling of SDA soybeans or oil with 

commodity or other specialty soybean products. 

This document describes the intended uses for SDA soybean oil, current processes for handling 

vegetable oils, and potential impacts to commodity soybean oil as well as other vegetable oils 

from the commercial introduction of SDA soybean oil. This document also describes the CLSS

which Monsanto will implement during the initial phase of the product introduction.

2. Intended Uses SDA Soybean

MON 87769 is a sustainable source of omega-3 fatty acid for food use. SDA has fewer double 

bonds than other omega-3 fatty acids such as EPA (20:5) and DHA (22:6). Therefore, SDA 

soybean oil is more stable to oxidation (i.e., less prone to fishy or rancid odors and taste) 

compared to other oils containing EPA or DHA, thereby expanding the potential formulation 

options for food companies and consumers. SDA soybean oil is generally recognized as safe in 

the United States8. 

SDA is a metabolic precursor to the long chain omega-3 fatty acids, EPA and DHA, in humans 

and animals and is found in products such as fish and fish/algal oils. Although the benefits of 

omega-3 fatty acid consumption are widely recognized, typical Western diets contain very little 

fatty fish, while at the same time current foods and supplements provide limited alternatives to 

satisfy consumer demand for long chain omega-3 fatty acids. An alternative approach to 

increase omega-3 fatty acid intake is to provide a wider range of foods that are enriched in 

omega-3 fatty acids so that people can choose foods that suit their usual dietary habits. Human 

and animal studies have shown that 1 g dietary SDA is approximately equivalent to 200 - 300 mg

dietary EPA in terms of increasing tissue concentrations of EPA. Thus, MON 87769 can serve 

as an alternate source of an omega-3 fatty acid to help meet the need for increased dietary intake 

of long chain omega-3 fatty acids in food. SDA soybean oil can be used for the production of 

margarine, shortenings, salad dressings, ready-to-eat foods, and other food categories described 

in the GRAS notification9. The use of SDA soybean oil in selected food categories could 

provide a wide range of dietary alternatives for increasing omega-3 fatty acid intake. 

 

8

http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASListings/ucm185688.htm

9

http://www.accessdata.fda.gov/scripts/fcn/gras_notices/grn000283.pdf
159

Given the targeted commercial application of SDA soybean as an alternate source of omega-3 

fatty acids in food it is anticipated that MON 87769 will be a low acreage product planned 

initially for production in North America. The oil derived from MON 87769, however, has a 

unique fatty acid profile and will be identity preserved to maintain its value and assure its use in 

appropriate food applications. The co-product, soybean meal, derived from MON 87769 has 

been shown to be compositionally comparable to other commodity soybean meal and will be 

used in a manner similar to commodity soybean meal. 

As a food ingredient, SDA soybean oil uses would be limited to those applications that 

demonstrate (1) functional suitability for incorporation into food products, (2) acceptable sensory 

properties (no off-flavors or bad taste) to the food, and (3) appropriate stability profile and shelf 

life of food products containing SDA soybean oil during food production and storage. As 

expected, SDA soybean oil from MON 87769 contains high levels of SDA (approximately 20-30 

wt% of total fatty acids). Vegetable oils containing high levels of polyunsaturated fatty acids 

(PUFUs) like SDA are known to undergo rapid oxidation during frying applications and will 

impart undesirable taste and odor to the fried foods. Therefore, SDA soybean oil will not be 

suitable for all food applications and may not be suitable as a substitute for saturated fats in food 

recipes. However, SDA soybean oil can partially replace commodity soybean oil or other oils in 

many food categories. As is the case with fish oils, containing omega-3 fatty acids, 

hydrogenation of SDA-containing oil would be without purpose, as hydrogenation would 

eliminate the benefits of long chain polyunsaturated fatty acids (LCPUFAs). Thus, 

hydrogenation is not applicable to SDA soybean oil from MON 87769. The current anticipated 

food applications for SDA soybean oil are in baked goods and baking mixes, breakfast cereals 

and grains, cheeses, dairy product analogs, fats and oils, fish products, frozen dairy desserts and 

mixes, grain products and pastas, gravies and sauces, milk products, nuts and nut products, 

poultry products, processed fruit juices, processed vegetable products, puddings and fillings, 

snack foods, soft candy, and soups and soup mixes10. 

3. Market Potential of SDA Soybean

Consumer demand for long chain omega-3 fatty acids through food and supplements is expected 

to continue to grow. As of 2008, the United States omega-3 ingredient market for marine oils 

was estimated at 26,447 metric tons (MT) per year, with 13.8% of that volume being consumed 

in functional foods. Furthermore, the projected average annual growth rate for this industry 

between 2008 and 2013 is 13.4% (Strategic Analysis of the North American Marine and Algae 

Oil Omega-3 Ingredients Market, Frost & Sullivan, March 201011). The value added product 

derived from MON 87769 is SDA soybean oil. SDA soybean oil provides increased alternatives 

 

10 FDA Food classifications 21 CFR §170.3(n).

11 http://www.frost.com/prod/servlet/report-brochure.pag?id=N73E-01-00-00-00
160

for food companies to formulate omega-3 fatty acids into a wider range of foods. Because SDA 

soybean oil can be used in wider food categories, Monsanto estimates, for the purposes of this 

analysis that the industry growth of omega-3 oils in functional foods could increase by 26.6%. 

For the purposes of this analysis, Monsanto assumed that SDA soybean oil could capture 100% 

of that incremental growth, which, given market dynamics, may over estimate the demand for 

this oil. SDA soybean oil will typically contain 20% SDA, the expected relative conversion of 

SDA to EPA in humans is estimated at about 5:1 and marine oils in average may contain about 

30% long chain omega-3 fatty acids (James et al., 2003 and Lemke et al., 2010). As a result, it is 

expected that about 7.5 times the volume of SDA soybean oil might be needed to satisfy the EPA 

equivalent amount currently provided by other marine oils. Under such a scenario, and assuming 

this growth is sustained at that constant level through 2016 the incremental amount of SDA 

soybean oil needed to satisfy that 26.6% industry growth would be approximately 20,000 MT. 

Furthermore, assuming an average oil yield of 0.2 MT/acre for soybean, this would equate to 

around 100,000 acres per year of SDA soybean needed to be grown to satisfy the U.S. demand 

for SDA soybean oil derived from MON 87769. It is foreseeable that global market demands for 

omega-3 containing foods may augment the U.S. soybean acres grown with MON 87769 for the 

purposes of SDA soybean and/or SDA soybean oil exports. The United States is the largest 

producer of soybeans and regularly exports soybean and soybean products to global markets. In 

2010 approximately 75 million acres of soybean crop was grown in the U.S. producing 

approximately 87 million MT of soybeans. 

4. Stewardship of SDA Soybean

Monsanto is committed to product stewardship12 and adhere to the BIO Product Launch 

Stewardship Policy13. In compliance with BIO's Product Launch Stewardship Policy, Monsanto 

considered Annex 2 “Special Use Traits in Commodity Crops” to develop launch plans for SDA 

soybean including: (1) identifying relevant stakeholders for the trait and crop and engaging them 

in dialogue and outreach regarding use of SDA soybean, (2) conducting a market and trade 

assessment to evaluate the potential impact from the introduction of MON 87769 to the market 

place, and (3) implementing a closed loop stewardship system to direct MON 87769 and derived 

products to their proper channels and developing a risk mitigation plan. 

4.1. Stakeholder Dialogue and Outreach

Monsanto is committed to dialogue with key industry stakeholder groups and has held several 

meetings with the National Oil Processors Association (NOPA) as well as other key industry 

associations such as the North American Export Grain Association (NAEGA), National Grain 

 

12 http://www.monsanto.com/ourcommitments/pages/product-stewardship.aspx

13 http://www.bio.org/letters/Product_Launch_Stewarship_12_10_09.pdf; 
161

and Feed Association (NGFA), National Agri-Marketing Association (NAMA), American 

Bakers Association (ABA), and Grocery Manufacturers Association (GMA). Soybean grower 

organizations consulted include: American Soybean Association (ASA), United States Soybean 

Board (USB), and many state soybean associations. Additionally, Monsanto has kept 

QUALISOY, a collaborative program sponsored by USB that serves as an independent third 

party resource for information on trait-enhanced soybean oils, informed of the plans for this 

product, along with dietary and nutrition thought leaders. Monsanto continues to have 

conversations with, and considers the input of several soybean and food industry key

stakeholders regarding the oil composition, stewardship plan and performance of MON 87769 

oil.

Monsanto has been marketing specialty Vistive low linolenic soybeans to growers since 2005. 

As grower and market demand for this specialty soybean product has grown, we have continued 

to work with processors to assure adequate testing methods and quality processes are applied to 

assure that the commodity soybean supply stream is not impacted. At a minimum, the same 

outreach, education, and quality principles will be applied as we further develop SDA soybean 

stewardship and commercialization plan. These quality systems are described in the following 

sections. 

4.2 Market and Trade Assessment

Approximately 85 million MT of soybeans are produced in the U.S. annually and the U.S. is a 

leading exporter of soybean, soybean meal and soybean oil to global markets. Approximately 

12% of soybean grown is specialty soybean produced for a specific market or use14. These 

soybean varieties are specified by buyers and end-users of soybean for production, and premiums 

are paid for delivering a product that meets purity and quality standards of that soybean variety. 

The specialty, value-added, product may be the whole soybean or, in the case of MON 87769, a 

processed fraction such as the oil. Product differentiation and market segmentation in the 

specialty soybean industry includes mechanisms to keep track of the soybean (traceability), 

methods for identity preservation (IP), including closed-loop stewardship systems, and quality 

assurance processes (e.g., ISO9001-2000 certification), as well as contracts between growers and 

buyers that specify delivery agreements within product specifications.

Monsanto has conducted a market and trade assessment to anticipate and consider the potential 

impacts within the value chain from the introduction of SDA soybean, and to commodity

soybean oil as well as other vegetable oil in the market place. Soybean is a globally traded 

commodity with the U.S. being the top global producer15. Biotechnology-derived crops are 

 

14 http://usb.adayana.com:8080/usb/jsp/login.jsp. Percent U.S. Soybean acreage estimate based on U.S. Domestic 

Consumption by Segment – 2008/09. D. Ludwig, personal communication, 2009.

15 http://www.soyatech.com/oilseed_statistics.htm
162

subject to regulation in many countries. In order to support free trade in soybean, Monsanto is 

pursuing regulatory approval for MON 87769 and any stacked products intended for 

commercialization in all key soybean export countries with a functioning regulatory system. 

International regulatory authorities are evaluating the food and feed safety of MON 87769 as 

well as the processed fractions derived from MON 87769. It is expected that uses of SDA 

soybean oil would be similar on a global basis. Defatted soybean meal from MON 87769 is 

similar to commodity soybean meal and therefore it can be comingled with commodity soybean 

meal upon gaining regulatory approval from all key soybean export countries that have 

functioning regulatory systems. 

The stewardship system will be designed to prevent the comingling of SDA soybean or oil with 

commodity products. The market and trade assessment supports the conclusion that in the 

unlikely event that comingling of SDA soybean or oil in the commodity stream did occur, the 

impact would be minimal. Sections 4.2.1, 4.2.2 and 4.2.3 below discuss in detail the potential 

impacts of inadvertent comingling of SDA soybean, oil, and meal with commodity soybean, oil, 

and meal in the market place and show that any such comingling would have only minimal 

impact to current soybean and vegetable oil markets. As discussed earlier, the SDA soybean and 

oil are for a specialty market and are not meant to be part of the commodity chain. The 

comingling scenarios and impacts are presented as worst case situations. Oilseed processors and 

users of vegetable oils are accustomed to the presence of numerous vegetable oils that are 

currently available for various food applications. The comingling levels where an impact would 

occur could only happen if there were a major deviation in the system which is highly unlikely as 

routine analytical methods are in place. Additionally, there is economic motivation, legal 

contracts, standard operating procedures (seed quality to end user), and demonstrated 

competency handling other vegetable oils of similar fatty acid profiles.

4.2.1 Potential Impact to Commodity Soybean in the Market Place

The impact from comingling was assessed based on the following , scenario: An inadvertent 

unloading of a truck containing 100% SDA soybean into the commodity stream at an elevator or 

processor where the event goes unnoticed. This scenario was chosen because it represents a 

“worst case” situation. This is unlikely to occur because a farmer producing SDA soybeans is 

financially motivated to identity preserve the SDA soybean from commodity soybean during 

harvest to realize the premium paid upon delivery. Further, comingling can be identified via 

routine fatty acid analysis or QC checks before the oil is shipped from the processing facility. 

All soybean oil is analyzed by gas chromatography (GC) to determine the fatty acid profile prior 

to shipping. This information is placed on the “Certificate of Analysis” (CofA) accompanying 

the shipment. Any commingling of commodity oil with SDA soybean oil should be identified 

prior to loading for export shipment, which minimizes commingled oil arriving at an exporting 

country. 
163

For the purposes of this analysis, the following assumptions were made: the load limit on roads 

in most soybean producing states is 80,000 lbs gross weight. The empty weight of most semi 

trucks is at or below 35,000 lbs, leaving a load capacity of 45,000 lbs (the difference). At 60 lbs 

per bushel, a standard semi truck will haul less than 800 bushels of soybeans. Thus, this 

commingling scenario assumes 800 bushels of SDA soybean commingled with commodity 

soybean.

Upon processing of the comingled soybeans, 800 bushels of SDA soybeans would yield 

approximately 8000 lbs of refined SDA soybean oil. The capacity of the smallest soybean oil 

holding tank at U.S. processing plants is approximately 200,000 lbs. Thus the accidental 

comingling of the truck load of SDA soybean will result in a 25X dilution of SDA soybean oil in 

a 200,000 lb tank of commodity soybean oil. In this situation, 8000 lbs of 20% SDA soybean oil 

will be diluted to 200,000 lb resulting in a final SDA concentration of 0.8% SDA in commodity 

soybean oil. The presence of 0.8% SDA in commodity soybean oil will have no impact to 

human health because the oil has been through the food safety assessment16. Impacts to food 

labeling and oil performance are discussed in Section 4.2 of this document. 

Another scenario would involve delivery of 800 bushels of SDA soybean to a grain elevator. In

this case, the SDA soybean would be diluted with commodity soybean in a grain storage bin that 

typically holds 100,000 to 500,000 bushels of soybean, resulting in 125X to 625X dilution of 

SDA soybean in commodity soybean. The commodity soybean oil produced from this 

comingling scenario will only have SDA ranging from 0.03% to 0.16% of total fatty acids.

Soybeans are exported as whole beans or as processed fractions. Soybean oil is commonly

exported via cargo ships in containers with a capacity of approximately 40,000 lbs. These oil 

filled containers are transferred from the cargo ships to trucks at the importing ports. If a 

container of SDA soybean oil unintentionally ends up in a port where it is not suppose to be, it 

can be identified and diverted back to the country of origin or to another importing country. Due 

to the CofA and the high value of the product, the chance of SDA in soybean oil entering into the 

export market unintentionally is very small. 

Commodity soybean shipped for export are typically loaded into unit trains (360,000 bushels) or 

barges (50,000 bushels/barge) that eventually are loaded into 2 million bushel ocean going 

vessels. Before a ship loaded with commodity soybean reaches a destination country, the 

inadvertent delivery of a truck containing 800 bushels would be mixed and diluted within 2 

million bushels. The amount of SDA soybean in the vessel would be less than 0.04% of the total 

amount, or 2500X dilution. The soybean oil produced from this commingled soybean will have 

 

16 http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASListings/ucm185688.htm
164

SDA at level below 0.008% of total fatty acids, which is the more than six time below the 

CODEX limit of quantitation for fatty acids in vegetable oil (0.05%).

4.2.2 Potential Impact to Commodity Soybean Meal in the Market Place

Monsanto provided information to USDA in the petition demonstrating that the composition of 

the meal from MON 87769 is equivalent to meal derived from conventional soybean and safe 

and wholesome for food or feed applications as commodity soybean meal. Defatted SDA 

soybean meal contains approximately 1% residual oil. According to the National Oil Processors 

Association defatted soybean meal should contain a minimum of 0.5% oil to meet quality 

standards and guidelines for soybean meal from domestic and international shipping (NOPA, 

2006). With the exception of the presence of minor amounts of the Pj6D and Nc15D proteins 

and de minimis amounts of residual oil, the soybean meal and other non-oil processed fractions 

used for animal feed and human food applications are unchanged from commodity processed 

soybean fractions. Upon receiving regulatory approval for MON 87769 in all major soybean 

export countries, SDA soybean meal can be comingled with commodity soybean meal in the 

market place. Therefore no trade impact is anticipated from the commingling of SDA soybean 

meal with commodity soybean meal. 

4.2.3 Potential Impact to Commodity Soybean Oil in the Market Place

Monsanto has assessed the impact due to the presence of SDA soybean oil on commodity and 

other vegetable oils. 

Areas of potential impact identified include the following: (1) food ingredient labeling, (2) 

nutritional facts panel labeling (3) functionality of the oil, and (4) sensory evaluation. This 

assessment has been shared with key stakeholders such as NOPA, NAEGA, ASA, QUALISOY, 

USB and GMA. 

Food Ingredient Labeling: 

The impact due to the presence of SDA soybean oil in commodity soybean oil from the 

perspective of soybean oil ingredient labeling was considered. SDA soybean oil contains two 

additional fatty acids (SDA and GLA) that are not present in commodity soybean oil. Therefore, 

we evaluated the potential impact to food ingredient labeling if SDA soybean oil was 

inadvertently present in the soybean oil that is added to food. 

The U.S. Food and Drug Administration requires that all ingredients present in a food to be 

declared with a few exceptions. Although the regulations do not explicitly define “ingredient” 

they do discuss a class of “incidental additives” that are not considered ingredients and yet can 

be present in a food. An “incidental additive” is exempt if, according to the regulations, it is 
165

present at “insignificant levels” and has no “technical or functional effect” in a food17. Residual 

product from a previous soybean oil processing run may occasionally be mixed into a different 

product in a new run. Such residual product would fit the concept of “incidental additive”18 and 

need not be included on the label. Thus, the unintended presence of insignificant amounts of 

SDA soybean oil in soybean oil is tolerated under the food label laws and should not impact the 

ingredient labeling of soybean oil or foods containing such oil. 

Nutrition Facts Panel Labeling: 

The FDA requires that information on fats to be declared on the nutrition facts panel of foods. 

They are (1) total fat, (2) trans fat, and (3) saturated fat. It is voluntary for a food company to list 

the amounts of monounsaturated fat and polyunsaturated fat on the nutrition facts panel. The 

nutrition facts panel of SDA soybean oil will be similar to commodity soybean oil because the 

total fat, saturated fat and trans fat content of SDA soybean oil is similar to commodity soybean 

oil. Many vegetable oil providers voluntarily list also monounsaturated and polyunsaturated 

fatty acids present in the oil. Since in SDA soybean oil one polyunsaturated fatty acid (LA) is 

replaced with two other (SDA and GLA) polyunsaturated fatty acids; the impact of comingling 

on nutrition facts panel labeling from listing mono and polyunsaturated fatty acid is negligible. 

Even though bottled SDA soybean oil is not an intended use at this time, a worst case assessment 

using 100% commodity soybean oil was considered to assess the potential impact of SDA 

soybean oil comingling with commodity soybean oil on nutritional facts panel labeling of bottled 

soybean oil. Table 1 shows the amount of SDA soybean oil that would be needed to be 

comingled with commodity bottled soybean oil in order to significantly impact the nutrition facts 

panel for major fatty acids on bottled soybean oil. Based on this analysis even 25% of SDA 

soybean oil comingled with commodity soybean oil will not significantly impact the nutritional 

facts panel label for soybean oil. This example illustrates that any incidental presence of SDA 

soybean oil in commodity soybean oil will not have any impact on the nutritional labeling of 

soybean oil or SDA soybean oil containing food products. Figure 1 shows the typical nutrition 

facts panel for commodity soybean oil (100 % soybean oil) and a theoretical nutrition facts panel 

for SDA soybean oil. 

 

17 21 CFR § 101.100

1821 CFR § 101.100(3)i
166

Table 1. Impact of Comingling SDA Soybean Oil with Commodity Soybean Oil on 

Nutritional Facts Panel Labeling for Bottled Soybean Oil 

Major Fatty Acids SBO1SDA 

SBO

1% SDA 

SBO in 

SBO

5% SDA 

SBO in 

SBO

10% SDA 

SBO in 

SBO

25% SDA 

SBO in 

SBO

Saturated Fat (g) 2.11 2.27 2.11 2.12 2.13 2.15

Polyunsaturated Fat (g) 8.35 9.05 8.36 8.38 8.42 8.52

Monounsaturated Fat 

(g)

3.19 2.15 3.18 3.14 2.98 2.93

1

SBO=Soybean Oil

Note: The impact of mixing SDA soybean oil (SDA SBO) on nutritional facts labeling for 

bottled soybean oil (SBO) is depicted in the table above. The impact to nutritional facts 

panel labeling was assessed at various percentages of SDA soybean oil mixed with 

commodity soybean oil.

 14 g serving size and FCC rounding rules applied. GLA and SDA included in 

polyunsaturated fatty acid calculation. Mono and polyunsaturated fatty acid labeling is 

voluntary. No change in trans fat.
167

Figure 1. Nutrition Facts Panel for Commodity Soybean Oil and Theoretical Nutrition 

Facts Panel for SDA Soybean Oil

Note: Nutrition facts panel generated using Genesis SQL R&D software (© 2011 ESHA 

Research), the same as used typically by food companies. Commodity soybean oil exists 

in the database. SDA soybean oil’s typical fatty acid composition was utilized to develop 

a theoretical nutrition facts panel.

100% Soybean Oil 100% SDA Soybean Oil
168

Oil Functionality: 

Oxidative Stability Monsanto conducted an assessment of the impact of the oxidative stability of 

commodity soybean oil comingled with SDA soybean oil. Figure 2 demonstrates that 

comingling of SDA soybean oil with commodity soybean oil decreases the Oxidative Stability

Index (OSI) of commodity soybean oil. The OSI stability index is an indicator of soybean oil 

stability. All oils and fats have a resistance to oxidation, which depends on the degree of 

saturation, antioxidant and pro-oxidant concentration, and prior abuse. Oxidation is slow until 

this resistance is overcome, at which point oxidation accelerates and becomes more rapid. The 

length of time prior to the acceleration of oxidation is referred to as the ‘induction period,’ and 

the point of maximum rate change is referred to as the OSI, and is reported in hours. The 

oxidative stability of soybean oil is significantly influenced by the proportion of 

monounsaturates to polyunsaturates. 

To assess the impact of comingling on the OSI, the OSI of 21 commercially available soybean 

oil as well as blends of commodity soybean oil with SDA soybean oil were evaluated. 

Commodity/SDA soybean oil blends were prepared in duplicate (wt./wt.) using SDA soybean oil 

in retail salad oil (soybean oil) obtained from a local St. Louis market. Neither oils contained 

added antioxidants. SDA soybean oil used for preparing the blends contained 22.9% of SDA 

(%wt of total fatty acid). Oil Stability Index measurements were obtained on an Omnion OSI

instrument at 110oC using AOCS Official Method Cd 12b-92. OSI was run in duplicate for each 

blend sample, and means were averaged to obtain the data points shown. Target blend accuracy

in the commodity/SDA soybean oil blends was confirmed by fatty acid composition determined 

using capillary gas chromatographic (GC) analysis (data not shown). The “Commercial soy” 

range shown in Figure 2 represents 21 unstabilized salad oils that were obtained at retail markets 

in St. Louis over a 3 year period and analyzed for OSI within 2 weeks of purchase. Oils were 

selected with ‘best by...’ dates of 6 to 24 months from date of purchase. The OSI values of these 

oils ranged from 5.63 to 9.68 with a median value of 6.66. SDA soybean oil is estimated to have 

decreased oxidative stability compared to conventional soybean oil (Figure 2). Based on this 

study it is reasonable to conclude that minor levels of SDA will not impact the OSI index of 

commodity soybean oil. At comingling levels of 12.5% of SDA soybean oil in commodity

soybean oil, the OSI index falls below the range observed for commercial soybean oils.
169

Figure 2. Oxidative Stability Index (OSI) of SDA Soybean Oil Blended with Commodity 

Soybean Oil

Heat Treatment Vegetable oils containing high levels of PUFA are known to undergo rapid 

oxidation during frying applications and are known to impart undesirable taste and odor to the 

fried foods. SDA soybean oil contains relatively high levels of PUFAs compared to other 

vegetable oils, and therefore, is not intended for frying applications. However, as part of the 

evaluation of the potential impact of SDA soybean oil on the functional properties of commodity

soybean oil, the influence of SDA soybean oil on the ability of fry oil to withstand heat treatment 

was determined. From a practical standpoint, commercial fryers use the level of polar materials 

formed during frying as a measure of oxidation and to determine the fry life of oil. Total polar 

material values are often used to determine when the oil has deteriorated to a point where the oil 

can no longer be used (Ortheofer and List, 2007). When the polar material reaches the threshold 

level of 24%, the oil is typically discarded and fresh oil is used. Polar compounds are 

byproducts that are generated as the oil degrades in quality. A common means of measuring 

total polar material in oils is by the use of the Ebro Food Oil Meter (Ebro International, Lino 

Lakes, MN). As oil degrades during frying, there is an increase in the polar materials that affect 

the dielectric constant of the oil. Measurements are taken of the fry oil throughout the length of 

the fry study to determine when the oil has reached 24% total polar material (TPM), which 

typically indicates the need to discard the oil. Figure 3 shows the time in hours that it took for 

each SDA soybean oil/commodity soybean oil blend to reach 24% TPM during frying. The 

results indicate within the range of blends tested the level of SDA soybean oil had minimal 

impact on the formation of total polar materials in the oil.

OSI range 

for 21 

12.5% SDA Soybean 

oil 

• 0% SDA 

Soybean Oil

0.05% 0.5% 5% 50% (log scale)

% SDA Oil in Commodity Soybean Oil

• 100% SDA 

Soybean Oil
170

Figure 3. Hours to Reach 24% Total Polar Material During Frying Application of Soybean 

Oil Containing Varying Amounts of SDA SoybeanOil

Food Sensory Assessment:

A sensory assessment of SDA soybean oil was performed to evaluate consumer acceptability of 

SDA soybean oil. Sensory assessment has concluded that the sensory attributes of SDA soybean 

oil is comparable to commodity soybean oil. Even though SDA soybean oil is not intended for 

frying application, sensory results for SDA soybean oil in the most challenging environment of 

high temperature food frying applications was evaluated as a worst case scenario. To determine 

the impact SDA soybean oil on the quality of foods prepared from blends of SDA soybean oil 

and commodity soybean oil, french fries were prepared. The five oil blends (ranging from 2.5 to 

15% SDA soybean oil) and commodity soybean oil were heated continuously for over 40 hours. 

During this time, batches of french fries were cooked in each of the oil samples and one batch 

each day of frying was evaluated for the difference in sensory properties from a control (100% 

commodity oil) using the Sensory Quality System method (King et al., 2002). Each panelist was 

provided a control fry and test fry and asked to rate the overall quality score (overall difference) 

along with the differences in individual French fry attributes. A rating of 5 indicates no 

difference, 4 slight difference, 3 difference, 2 significant difference and 1 extremely different. 

Figure 4 shows the results from this study. The outcome from the sensory evaluation showed 

that up to 15% of SDA soybean oil can be comingled with commodity soybean oil without 

impacting the flavor perception of fried food (Figure 4).

% 

SDA 

Soyb

ean 

oil in 

Soyb

ean 

Oil
171

Figure 4. Sensory Results from Frying Applications of Soybean oil Containing Varying Amounts of SDA Soybean Oil.

Ratings: 5 = No Difference; 0 = Completely different

0.0% SDA SBO

2.5% SDA SBO

5.0% SDA SBO

7.5% SDA SBO

10% SDA SBO

15% SDA SBO

Rating

Days
172

The market and trade assessment has concluded that in the unlikely event comingling did occur, 

the impact to labeling and functionality of commodity soybean oil would be minimal. Monsanto 

will have an appropriate stewardship plan in place to direct MON 87769 and oil to its intended 

markets, both in its initial commercial phase when produced and used under CLSS as well as 

longer-term.

4.3 Risk Mitigation Plan

4.3.1 Stewardship Plan for MON 87769 - Closed Loop Stewardship System

To mitigate potential impacts to commodity soybean, a Closed Loop Stewardship System 

(CLSS) has been developed to support the commercialization of SDA soybean prior to obtaining 

approvals in key soybean export markets with functioning regulatory systems. The CLSS 

defines procedures and processes relevant to the production, handling, and processing of all 

stewarded materials generated within the closed loop. Stewarded materials include viable 

soybean seed and grain, meal, hulls, oil, and downstream co-products derived from the crude oil 

that are in direct control of Monsanto, its licensees or partners, and their customers. Monsanto 

will continue to utilize the CLSS through the initial product introduction phase until necessary 

global approvals are received from key soybean export countries with functioning regulatory 

systems. After the approvals are received, Monsanto will refine and update the stewardship 

system for long-term implementation based on the experience developed during the introduction 

phase and in consultation with key stakeholders. 

Under the CLSS, Monsanto will develop and implement best practices and systems consistent 

with the Excellence Through Stewardship19 initiative. Monsanto will carefully evaluate 

capabilities of partners and downstream entities to contain downstream products to their intended 

market(s) and include terms and conditions in agreements with those partners or entities. These 

agreements will require that appropriate quality management systems (QMS), including both 

quality assurance (QA) and quality control (QC), are in place to manage and verify containment 

of all stewarded materials in countries of production and use.

Monsanto will only work with downstream partners that have proven traceability, identity 

preservation, and CLSS production capabilities. Monsanto, its licensees, partners and processors 

will implement an annual auditing process for material under their control. Commercial 

production of soybean seed for planting and harvested soybean and the subsequent processing or 

manufacturing of stewarded end use products requires strict adherence to established processes 

under the CLSS to ensure each material is handled and used appropriately. If any part of the 

process is contracted out to a third party, Monsanto will require a Stewardship Management Plan 

 

19 Excellence Through Stewardship (ETS) is an initiative to promote the global adoption of stewardship programs 

and quality management systems for the full life cycle of biotechnology-derived plant products.
173

that meets CLSS standards. Monsanto reserves the right to audit these plans directly or through 

a third party.

Activities under the CLSS are organized into five relevant sections identifying critical control 

points: (1) Production of SDA Soybean Seed for Planting, (2) Production of SDA Soybean for 

Processing, (3) SDA Soybean Processing and Oil Refining, (4) SDA Soybean Oil Packaging and 

Storage, and (5) SDA Soybean Oil Distribution to Food Company Supply Chain. The 

information presented in each section describes the purpose, scope, and procedures necessary to 

conduct and verify the proper handling and use of all relevant materials under the CLSS.
174

Figure 5. Parts of the Closed Loop Stewardship System and Critical Control Points

Grain 

Processing & 

Oil Refining 

3

Seed 

Production 

1

Food 

Company 

Distribution 

5

Grain 

Production 

2

Oil Packaging 

& Storage

Grain 

Elevator 

4

Contracts and Agreements

Segregated Storage

Analytical Testing

SOPs

1

Monsanto contracts approximately 1 M acres of soybean seed production each year produced under ISO 9000 

Standards

2

Contract production with processor – on farm storage and segregation – analysis of grain upon delivery to 

processor or grain elevator

3

Grower delivers to a processor, on-site segregated storage, analytical testing conducted

4

Grower delivers to elevator, analytical testing methods on-site, elevator holds soybeans until called by processor

5

Food Co handles multiple vegetable oil ingredients, segregated storage, formulation supported by analytical 

methods, SOP’s in place to assure product quality 
175

The requirements and processes for activities at each of these control points under a CLSS are 

consistent with Monsanto stewardship guidelines. These guidelines include processes to prevent 

commingling with commodity soybean seed, soybean, and oil (e.g. isolation, equipment cleaning 

and segregated storage). All Monsanto and non-Monsanto personnel involved with producing 

material under the CLSS are required to follow these guidelines and requirements.

Detection Methods Monsanto has developed event-specific detection methods to detect the 

MON 87769 event in articles of commerce including soybean seed, harvested soybean, soybean 

meal and oil. More importantly, Monsanto has developed analytical methods to assess the fatty 

acid profile for SDA soybean oil as well as detect the presence of SDA in vegetable oil. 

Monsanto will provide these methods to the industry upon request. Oil processors and 

downstream distributors are accustomed to using oil analysis methods during their normal course 

of business. Fatty acid profile analyses of soybean oil are considered routine within the industry.

Production of SDA Soybean Seed for Planting:

Monsanto is a leader in crop biotechnology having successfully introduced numerous 

biotechnology-derived crops to the marketplace globally. Monsanto has developed and 

implemented seed quality standards and practices to validate soybean seed meets the standards 

established for purity of a trait. These standards apply to all soybean seed sold by Monsanto and 

are based upon measures that seed producers put in place to assure the genetic purity of 

improved planting seed. This system is used to assure that farmers receive seed of known 

quality with a minimum level of off type seeds.

The first step in production of SDA soybean is the production, processing and delivery of high 

quality parent seed to the grower. Monsanto’s seed manufacturing organization uses specific 

SOPs and documentation forms to ensure compliance with Monsanto stewardship and 

compliance standards. The entire seed production process at the majority of the seed companies 

and tollers operates using International Organization for Standardization20 (ISO) certification 

standards and include internal and external audits (ISO, 2009). By following ISO quality 

standards it is possible to validate that the processes are followed which have been designed to 

generate the desirable characteristics of seeds and services such as quality, safety, reliability, and 

efficiency. The ISO standards represent an international consensus on good management 

practices with the aim of ensuring that the organization can consistently deliver excellent product 

or services. The standards not only must meet the customer’s requirements and applicable seed 

regulatory requirements, but also must aim to enhance customer satisfaction and achieve 

continual improvement of its performance in pursuit of these objectives (ISO, 2009).

 

20http://www.iso.org/iso/ims_2009.htm
176

Commercially certified soybean seed must meet state and federal seed standards and labeling 

requirements. The Association of Official Seed Certifying Agencies (AOSCA) standards for 

certified soybean seed are as follows: 98% pure seed (minimum), 2% inert matter (maximum). 

The inert matter can contain up to 0.05% weed seed (maximum, not to exceed 10 per lb.), 0.60% 

total of other crop seeds (maximum), 0.5% other varieties (maximum, includes off-colored beans 

and off-type seeds), 0.10% other crop seeds (maximum, not to exceed three per lb.), and have 

80% germination and hard seed (minimum) (AOSCA, 2009). Seed that meets or exceeds these 

standards are provided in appropriately labeled seed bags to growers. Monsanto’s seed 

manufacturing practices for MON 87769 will be designed to contain MON 87769 within the 

boundaries of the production system thereby assuring that levels of the trait and the subsequent 

SDA and GLA fatty acids do not cause impacts to conventional soybeans or other commodity 

soybean varieties produced at seed manufacturing sites.

Production of SDA Soybean for Processing:

SDA soybean will be produced under contracts similar to those currently issued by processors or 

elevators for commercial specialty soybean such as food grade, organic, Vistive low linolenic or 

other specialty soybeans. 

The income opportunity is achieved by the farmer only when the soybean is delivered to the 

processor within specifications. Therefore, the motivation is a financial incentive for the farmer 

to avoid comingling with commodity soybean, keeping SDA soybean identity preserved within 

system of seed – farmer – processor. Many farmers may willingly choose to plant all their 

acreage to specialty soybeans because it eliminates any risk of comingling that may occur during 

the harvest. If a farmer chooses to produce the specialty soybean for the processor, the farmer 

will arrange to store the soybean on farm or at their local elevator, if the elevator is participating 

in the specialty program with the processor.

The steps involved in securing soybean production are:

1. Monsanto, its licensees, partners or processors will be responsible to issue production 

contracts. These contracts will be either to an elevator or directly to the farmer. If issued 

to an elevator, the elevator will in turn issue contracts with farmer customers in the 

amount of acreage established in its processor contract. The contract will include number 

of acres and the timeline for the delivery of harvested soybeans.

2. Monsanto, its licensees or partners will distribute SDA soybean seed to the farmer after 

verifying that the farmer has a valid contract that has been issued for SDA soybean 

production and stewardship in their operation. This will include an amount of seed 

needed to plant the number of acres established on the production contract by the 

processor or elevator.

3. Monsanto, its licensees or partners will work with all parties involved to confirm and 

reconcile acres contracted with seed sales. Processors can plan processing schedules 
177

according to demand of the oil and supply of SDA soybean anticipated from contracted 

farmers.

4. After harvest, the farmer will deliver the harvested SDA soybean to the location specified 

in his contract, either a participating elevator or processor. If delivered to the elevator, 

the elevator will keep the SDA soybean segregated from commodity soybean and pay the 

farmer any premiums as applicable, provided it passes the analytical testing. The 

elevator will deliver the SDA soybean to the processor as delivery windows and crush 

schedules have been established. Upon delivery of SDA soybean by the farmer, samples 

will be analyzed from every truckload. This is to confirm the soybean contains the SDA 

trait as required by the production contract. Upon confirmation that the SDA soybean 

meets specification, the processor or elevator will approve the premium payment to the 

farmer. SDA soybean that does not meet specifications at the elevator or processor will 

be segregated, processed and the oil will be directed to appropriate uses such as for the 

production of biofuel.

Soybean Grain Elevator Grain elevators play an important role in specialty programs with their 

long term storage of the soybeans. Because processing facilities crush soybeans throughout the 

year, soybeans used to supply these crush plants need to be stored year round. Farmers typically

prefer to empty their storage prior to planting of the new crop and prior to temperature warm up 

in the spring. The warm spring and summer weather presents challenges as condensation can 

build up in the bins creating moisture-related issues that make soybean-eating insects more 

active. To avoid this, commercial elevators have expert grain managers on staff to monitor 

soybean quality and keep soybean in good condition in all weather situations throughout the 

year. Commercial grain elevators are also better equipped to ship soybeans to processors during 

times of severe weather even when farmers cannot get to their bins. 

Processors will therefore enter into supply contracts with commercial grain elevators and work 

with farmers to establish inventories and to assure proper routing of SDA soybean through the 

supply chain. The elevator pays the farmer the specialty soybean premium upon successful 

analytical testing performed at the elevator location. Testing equipment will be provided as 

needed by Monsanto to participating elevators. 

In order for the elevator to be reimbursed for the premiums paid out to farmers that have 

delivered SDA soybeans to them, the elevator must in turn preserve the identity of the soybean 

as it is delivered to the processor. Every load delivered to the processor by the elevator will be 

analyzed to make this determination. Processors will approve the premium payment to the 

elevator after analysis of the soybean to confirm the SDA trait. SDA soybean that does not meet 

specifications at the elevator or processor will be segregated, processed and the oil will be 

directed to appropriate uses such as for the production of biofuel.
178

SDA Soybean Processing and Oil Refining:

All SDA soybean processors must be approved in advance by Monsanto. In order for the 

processor to be approved by Monsanto to process SDA soybean, certain requirements must be 

met. They must posses the ability to store, segregate and identity preserve SDA soybeans. They

must demonstrate the ability to clean the equipment associated with the receiving and subsequent 

handling of SDA soybeans. The processor’s facility must have procedures in place and the 

ability to assure that SDA soybean processing, extracting, and oil refining equipments can be 

flushed to commercially acceptable standards after processing SDA soybeans. Monsanto and the 

processor will enter into an agreement to establish the terms and conditions of SDA soybean 

processing services. These agreements will also include terms for distribution of SDA soybean 

co-products resulting from processing as stewarded products within the United States prior to 

receiving necessary regulatory approvals in soybean export markets. The resulting oil from 

processing SDA soybean is generally recognized as safe in the United States. 

Upon the transition from commodity soybeans to the SDA soybeans, a sample of crude oil is 

required to confirm the presence of the appropriate fatty acid composition (FAC) unique to SDA 

soybean oil. Crude oil will be collected and handled in a way that ensures that any SDA soybean 

oil as well as SDA soybean oil comingled with commodity soybean oil are handled in an 

appropriate manner and segregated from other oils. This will include all comingled oil before 

and after the collection of SDA soybean oil. Testing methods will be used to aid in identifying 

the appropriate time to start and stop collecting crude SDA soybean oil. Storage tanks approved 

for SDA soybean oil will be assigned for the storage of crude and refined SDA soybean oil. 

Upon the completion of SDA soybean processing, a commodity soybean flush will be initiated. 

After all SDA soybean and commodity soybean used to flush the channels have been processed, 

crude oil exiting the extractor will be sampled and analyzed to confirm the equipment has been 

flushed to an acceptable level, yielding commercially acceptable commodity soybean oil. Offspec, commingled or flush SDA soybean oil will be segregated from commodity soybean oil and 

directed to appropriate use such as for the production of biofuel. 

SDA Soybean Oil Packaging and Storage:

Soybean oil produced under the CLSS will be distributed as a stewarded product within the 

United States until receiving approvals in all key soybean export markets. An agreement will be 

executed between Monsanto, its licensees, partners, the processor and/or the packager to 

establish the terms and conditions for packaging stewarded SDA soybean oil at a contract 

packaging facility. A separate agreement will be executed with a long-term storage facility, if 

used, to establish the terms and conditions for SDA soybean oil receipt, storage, and distribution. 

Bulk liquid semi-trailers (tankers) will be used to transport packaged and/or bulk SDA soybean 

oil. Refined, bleached, and deodorized (RBD) SDA soybean oil packaging will be conducted in 

an area that is clean, secure, and segregated to eliminate potential comingling with commodity 
179

soybean and/or other vegetable oils. The containers will be properly labeled using 

predetermined methods that will include chain of custody documentation. Periodic visual 

inspections will occur in and around the packaging area for the collection and disposal of any 

spilled oil or damaged containers. All semi-trailers used in the transportation of bulk SDA 

soybean oil will be verified to be clean at the processing plant or other Monsanto approved 

facility prior to being released. After packaging is complete, the facility will be flushed with 

adequate amounts of commodity soybean oil to remove SDA soybean oil and return the oil 

stream to commodity soybean oil specifications. Flush oil containing SDA soybean oil will be 

segregated and directed to appropriate use such as for the production of biofuel.

SDA Soybean Oil Distribution to Food Company Supply Chain:

Monsanto, its licensees and/or partners will execute agreements with food companies to establish 

the terms and conditions for the use of stewarded SDA soybean oil. During the development of 

these contracts, it will be necessary to verify that the food companies have the capabilities in 

place to control and limit distribution of stewarded products and track all products that use 

specific batches of the SDA soybean oil as ingredient. These contracts will include stewardship 

obligations and will require compliance including auditing. Third party consultants will be used 

if necessary under the CLSS. These third party consultants will have expertise in supply and 

demand chain procedures, to enable verification of a food company’s capabilities. 

SDA soybean oil will be used by the food industry and will be supplied to specific customers by

Monsanto, its licensees or partners and suppliers after verifying that it meets specific customer 

requirements including quality factors. From the time the oil is packaged until it is utilized at the 

specific customer’s facility there will be proper identification of the oil through labeling and 

manufacturing codes allowing for sufficient product traceability. Individual facilities will utilize 

proprietary inventory and ordering systems that are in place to insure that the appropriate oil is 

ordered, delivered and utilized.

Food companies will use SDA soybean oil as a food ingredient consistent with the GRAS 

notification21. Each individual food company has in place systems for ingredient (oil) ordering, 

receipt, storage, access and lot identification at specific manufacturing locations, as well as 

finished product (the food which incorporates SDA soybean oil) batch identification, 

manufacturing facility, storage, shipment to distribution centers, customer order picking, 

customer order shipment and receipt. Appropriate procedures are currently in place to ensure 

traceability from receipt of the ingredient through distribution to a specific retailer’s facility.

Food manufacturing facilities also comply with federal and state requirements for good 

 

21 http://www.accessdata.fda.gov/scripts/fcn/gras_notices/grn000283.pdf
180

manufacturing practices and product traceability. Supply chain consultants can be employed to 

confirm appropriate systems have been established that meet ingredient and product traceability 

requirements.

Incident Response

All activities conducted by Monsanto and non-Monsanto personnel under the scope of the CLSS 

must be consistent with Monsanto’s corporate expectations for regulatory and stewardship 

compliance prior to obtaining all relevant global regulatory approvals. Monsanto has an incident 

response policy in place. If an unforeseen process failure or a breach of containment of 

stewarded material occurs, the CLSS incident response would be managed according to 

Monsanto’s Global Product Stewardship and Quality process and procedures document. The 

Incident Response Process engages a multi-disciplinary team for immediate response 

investigation, assessment and mitigation of any potential adverse impacts that could result from 

the process failure. The incident investigation and analysis process will determine the reason for 

the occurrence and develop recommendations for corrective action including process 

improvement to prevent similar occurrences in the future. 

Development of Long Term Stewardship Processes 

The CLSS described above to support the commercialization of SDA soybean oil prior to 

obtaining all relevant regulatory approvals will be utilized through the initial product 

introduction phase until all relevant global approvals in key soybean export countries with 

functioning regulatory systems are received. Monsanto will refine and update the stewardship 

system for long-term implementation based upon the experience and learning developed during 

the CLSS production phase and through continued dialogue with stakeholders. This dialog will 

aid in the assessment and development processes while enabling transparent communication 

regarding policy implementation. The long-term stewardship plan for MON 87769 derived 

through these actions will be designed to ensure that the SDA soybean oil is directed to its 

intended specialty market.

Summary

SDA soybean offers U.S. soybean growers the opportunity to supply a value added and 

sustainable omega-3 alternative that will provide food industry with choices to satisfy a growing 

omega-3 market. The closed loop stewardship system for the production and handling of 

MON 87769 and derived products is designed to ensure that SDA soybean and oil will be 

isolated from commodity soybean and oil as well as other vegetable oils in the market place and 

are directed to their intended specialty uses. The market and trade assessment has concluded that 

in the unlikely event comingling did occur, the impact to labeling and functionality would be 
181

minimal. Because SDA soybean is generally recognized as safe in the United States22 and the 

defatted meal from SDA soybean is similar to commodity soybean meal, there would be no 

negative impact to human heath from the use of any of the other processed fractions produced 

from soybean due to comingling of SDA soybean with commodity soybean. Given the 

abundance of vegetable oils on the market and demonstrated ability of the system to adapt to 

consumer preferences incorporating new oils into existing food manufacturing processes, the 

introduction of SDA soybean is expected to be easily managed by existing industry mechanisms 

and identity preservation systems. Monsanto continues to engage stakeholders and educate them 

on the benefits of SDA soybeans and proper stewardship practices. 

 

22 http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASListings/ucm185688.htm
182

References

James, M.J., V.M. Ursin, and L.G. Cleland. 2003. Metabolism of stearidonic acid in human 

subjects: comparison with the metabolism of other n-3 fatty acids. American Journal of Clinical 

Nutrition 77:1140-1145.

Lemke, S.L., Vicini, J.L., Su, H., Goldstein, D.A., Nemeth, M.A., Krul, E.A., and Harris, W.S. 

2010. Dietary intake of stearidonic acid–enriched soybean oil increases the omega-3 index: 

randomized, double-blind clinical study of efficacy and safety. Am J Clin Nutr 92:766–75.

NOPA. 2006. Trading Rules for the Purchase and Sale of Soybean Meal. National Oilseed 

Processors Association, Washington, D.C.

Orthoefer, F. T. and List, G. R. 2007. Evaluation of Used Frying Oil in Deep Frying: Chemistry, 

Nutrition and Practical Applications, 2nd Edition. Erickson, M.D. Editor. p 329-342.

King, S. et al. 2002. The sensory quality system: a global quality control solution. Food 

Quality and Preference (13) 385-395.
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12 LIST OF PREPARERS

David Reinhold, Assistant Director, APHIS-BRS-Environmental Risk Assessment Program

Craig Roseland, Ph.D., APHIS-BRS-Senior Environmental Protection Specialist

Diane Sinkowski, APHIS-BRS-Environmental Protection Specialist

Khamkeo Vongpaseuth, Ph.D. APHIS-BRS-Environmental Protection Specialist