i 

# Monsanto Petition (09-SY-2000U) for Determination of Non-regulated Status of (MON 87769) Stearidonic Acid Soybean

OECD Unique Identifier:

MON 87769-7



## Draft Environmental Assessment

October 2011

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 (U SDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, sex, religion, age, disability, political beliefs, sexual or ientation, or marital or family statu s. (Not all prohibited bases apply to all programs.) Persons with disabilitie s 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, Direct or, Office of Civil Rights, Ro om 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 re port 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 re port factually on available data and to provide specific

information.

This publication reports research involving pesticides. All uses of pesticides must be regi stered by appropriate State and/or Federal agencies before they can be recommended.iiTABLE OF CONTENTS PAGE

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

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

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

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

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

1.5 APHIS Response to Petition fo r 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 .................................................. 14

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 ................................................................................................. 33

2.3.3 Air Quality .................................................................................................. 35

2.3.4 Climate Change ........................................................................................... 38

2.4 Biological Resources .......................................................................................... 40

2.4.1 Animal Communities .................................................................................. 40

2.4.2 Plant Communities ...................................................................................... 41

2.4.3 Gene Flow and Weediness .......................................................................... 42

2.4.4 Microorganisms .......................................................................................... 45

2.4.5 Biodiversity ................................................................................................. 46

2.5 Human Health .................................................................................................... 49

2.5.1 Public Health ............................................................................................... 49

2.5.2 Human Dietary Health ................................................................................ 50

2.5.3 Worker Safety ............................................................................................. 53

2.6 Animal Feed ....................................................................................................... 53

2.7 Socioeconomic ................................................................................................... 54

2.7.1 Domestic Economic Environment .............................................................. 54TABLE OF CONTENTS PAGE

ii 2.7.2 Trade Economic Environment .................................................................... 59

2.7.3 Social Environment ..................................................................................... 60

3 ALTERNATIVES..................................................................................................... 62

3.1 No Action Alternative: Continua tion as a Regulated Article ............................ 62

3.2 Preferred Alternative: Determination that MON 87769 Soybean is No Longer a Regulated Article ............................................................................................... 62

3.3 Alternatives Considered But Reject ed from Further Consideration .................. 63

3.3.1 Prohibit Any MON 87769 Soybean from Being Released ......................... 63

3.3.2 Approve the Petition in Part ........................................................................ 64

3.3.3 Isolation Distance between MON 87769 Soybean and Non-GE Soybean Production and Geographical Restrictions ................................................. 64

3.3.4 Requirement of Testing for MON 87769 Soybean ..................................... 65

3.4 Comparison of Alternatives ............................................................................... 65

4 ENVIRONMENTAL CONSEQUENCES ............................................................... 67

4.1 Scope of Analysis ............................................................................................... 67

4.2 Agricultural Production of Soybean ................................................................... 68

4.2.1 Acreage and Area of Soybean Production .................................................. 68

4.2.2 Agronomic Practices ................................................................................... 70

4.2.3 Soybean Seed Production ........................................................................... 72

4.2.4 Organic Soybean Production ...................................................................... 72

4.2.5 Specialty Soybean Production .................................................................... 74

4.3 Physical Environment ........................................................................................ 75

4.3.1 Water Resources ......................................................................................... 75

4.3.2 Soil Quality ................................................................................................. 76

4.3.3 Air Quality .................................................................................................. 77

4.3.4 Climate Change ........................................................................................... 77

4.4 Biological Resources .......................................................................................... 78

4.4.1 Animal Communities .................................................................................. 78

4.4.2 Plant Communities ...................................................................................... 80

4.4.3 Gene Flow and Weediness .......................................................................... 81

4.4.4 Microorganisms .......................................................................................... 84

4.4.5 Biodiversity ................................................................................................. 85

4.5 Human Health .................................................................................................... 87

4.5.1 No Action Alternative ................................................................................. 87

4.5.2 Preferred Alternative: Human Health ......................................................... 87

4.6 Animal Feed ....................................................................................................... 91

4.6.1 No Action Alternative: Animal Feed .......................................................... 91

4.6.2 Preferred Alternative: Animal Feed ............................................................ 91

4.7 Socioeconomic Impacts ...................................................................................... 92

4.7.1 Domestic Economic Environment .............................................................. 92

4.7.2 Trade Economic Environment .................................................................... 98TABLE OF CONTENTS PAGE

iii 4.7.3 Social Environment ................................................................................... 101

5 CUMULATIVE IMPACTS .................................................................................... 103

5.1 Assumptions Used for Cumula tive Impacts Analysis ...................................... 103

5.2 Cumulative Impacts: Acreage and Area of Soybean Production ..................... 104

5.3 Cumulative Impacts: Agronomic Practices ...................................................... 104

5.4 Cumulative Impacts: Soybean Seed Production .............................................. 105

5.5 Cumulative Impacts: Organi c Soybean Production ......................................... 106

5.6 Cumulative Impacts: Specialty Soybean Production ....................................... 106

5.7 Cumulative Impacts: Water Resources ............................................................ 106

5.8 Cumulative Impacts: Soil Quality .................................................................... 107

5.9 Cumulative Impacts: Air Quality ..................................................................... 108

5.10 Cumulative Impacts: Climate Change .............................................................. 108

5.11 Cumulative Impacts: An imal Communities ..................................................... 108

5.12 Cumulative Impacts: Plant Communities ......................................................... 108

5.13 Cumulative Impacts: Microorganisms ............................................................. 109

5.14 Cumulative Impacts: Biodiversity .................................................................... 110

5.15 Cumulative Impacts: Human Health ................................................................ 111

5.15.1 Cumulative Impacts: Worker Safety ......................................................... 111

5.15.2 Cumulative Effects: Public Health ........................................................... 112

5.16 Cumulative Impacts: Animal Feed ................................................................... 113

5.17 Cumulative Impacts: Domestic Economic Environment ................................. 113

5.18 Cumulative Impacts: Trade Economic Environment ....................................... 114

5.19 Cumulative Impacts: Social Environment ........................................................ 115

6 THREATENED AND ENDA NGERED SPECIES ................................................ 116

6.1 Cumulative Impacts of Stacking MON 87768 Soybean with a Glyphosate

Tolerant Trait on TES ...................................................................................... 119

7 CONSIDERATION OF EXECUTIVE OR DERS, STANDARDS, AND TREATIES

RELATING TO ENVIRONMENTAL IMPACTS ............................................... 122

7.1 Executive Orders with Domestic Implications ................................................. 122

7.2 Compliance with Clean Water Act and Clean Air Act .................................... 126

7.3 Impacts on Unique Characteristics of Geographic Areas ................................ 126

7.4 National Historic Preservation Act (NHPA) of 1966 as Amended .................. 126

8 REFERENCES ....................................................................................................... 128TABLE OF CONTENTS PAGE

iv APPENDICES

Appendix A FDA Substances Generally Recognized as Safe (GRAS) – Agency Response

Letter GRAS Notice No. GRN 000283

Appendix B APHIS Threatened and Enda ngered Species Decision Tree for FWS

Consultations

Appendix C Addendum 1 to the Petition. Market Impact of MON 87769 High Oleic Soybean Oil. Monsanto Petition No. 09-SY-201U

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 No rthern Tier states and the U.S. in 2007 along with other principal crops. ........................................................................16 Table 4: First and second most freque nt rotational crops following soybean. .................20 Table 5: Principle herbicides used in soybean production and pe rcentage of acres applied--selected states. ......................................................................................23 Table 6: Certified organic soybean acreage, 2007 and 2008 ............................................26 Table 7: Irrigation of soybean acr es in Northern Tier states ............................................31 Table 8: Water sources used for irrigation of soybean acres in Nort hern Tier states .......32 Table 9: Percentages of linoleic and linolen ic acid in various vegetable oil sources and U.S. consumption. ........................................................................................51 Table 10: Properties of select fatty acids ...........................................................................56 Table 11: Industrial soybean products 2009 ......................................................................59 Table 12: World soybean products 2009 ...........................................................................60 Table 13: Summary of issues of potential im pacts and consequences of alternatives .......65 Table 14: Comparison of fatty acid profile s for oil derived from MON 87769 soybean

with several other oil sources ..............................................................................79 Table 15: Comparison of percentage fatty acid in MON 87769 soybean with conventinal control (A3535) and commercial range ..........................................88 Table 16: U.S. vegetable oil prices ..................................................................................114

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 plan ts and the introduced changes in MON 87769 soybean .................................................................................................................5v 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 Serv ices (within USDA–APHIS)

Bt Bacillus thuringiensis protein

CAA Clean Air Act

CBD Convention on Biological Diversity

CFR Code of Federal Regulations (United States)

CH 4 methane

CLSS closed loop stewardship system

CO carbon monoxide

CO 2 carbon dioxide

CT conservation tillage

DNA deoxyribonucleic acid

DHA docosahexaenoic acid

EA environmental assessment

E. coli Escherichia coli

ECOS Environmental Conservati on 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

g/kg grams per kilogramvi ACRONYMS AND ABBREVIATIONS

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

NO 2 nitrogen dioxide

N 2 O 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

O 3 ozone

OECD Organization for Economic Cooperation and Developmentvii ACRONYMS AND ABBREVIATIONS

PIPs plant incorporated protectants

Pj.D6D Primula juliae ∆ 6 desaturase gene

PM 2.5 particulate matter with an aerodynamic di ameter less than or equal to 2.5

micrometers

PM 10 particulate matter with an aerodynamic di ameter 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

SO 2 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 Agricultur e-American marketing Service

USDA-ERS U.S. Department of Agricultur e-Economic Research Service

USDA-NASS U.S. Department of Agriculture-Nati onal 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 Fahrenheitviii1 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 H ealth Inspection Service (APHIS). APHIS provides leadership in ensuring the health and care of plants and animals. The agency improves agricultural productivity and competiti veness, and contributes to the national economy and the public health. USDA asserts th at all methods of agricultural production (conventional, organic, or the use of genetically engineered varieties) ca n 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 Fr amework) (51 FR 23302, 57 FR 22984). The Coordinated Framework, published by the Office of Science and Technology Policy, describes the comprehensive federal regula tory policy for ensu ring the safety of biotechnology research and products and explai ns how federal agencies will use existing Federal statutes in a manner to ensure publ ic health and environmental safety while maintaining regulatory flexibility to avoi d impeding the growth of the biotechnology industry. The Coordinated Framework is based on several important gu iding principles: (1) agencies should define those transgenic organi sms subject to review to the extent permitted by their respective statutory au thorities; (2) agencies are required to focus on the characteristics and risks of the biotechnology pr oduct, 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 regulato ry roles and authorities for the three major agencies involved in regulating GE organism s: USDA’s Animal and Plant Health Inspection Service (APHIS), the U.S. Food and Dr ug Administration (FDA), and the U.S. Environmental Protection Agency (U.S. EPA).

APHIS is responsible for regulating GE organi sms 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 plant-derived foods and f eeds, including those that are ge netically engineered. To help developers of food and feed derived from GE crops comply with th eir 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 cons ultation process. Th e FDA policy statement concerning regulation of products derived fr om 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-in corporated protectants (PIPs) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). U.S. EP A 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 Fe deral Food, Drug and Cosmetic Act (FFDCA) and regulates certain biological control or ganisms under the Toxic Substances Control Act (TSCA). The U.S. EPA is responsible for re gulating the sale, dist ribution and use of pesticides, including pesticides that are produced by an organism through techniques of modern biotechnology.

1.2 Regulated Organisms

The APHIS Biotechnology Regulat ory Service’s (BRS) mission is to protect America’s agriculture and environment us ing a dynamic and science-base d 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, inte rstate movement, or release into the environment) of certain GE organisms and products. A GE organi sm 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 or ganism, recipient organi sm, 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 CF R 340. Under § 340.6(c)(4), the petitioner is required to provide information related to pl ant 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 l onger subject to the regu latory 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 No nregulated 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 determina tion 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 pe tition, smaller amounts of three other fatty acids are produced in addition to the SDA, and expr ession of linoleic acid is reduced (Monsanto, 2010b). In the event of a determination of nonr egulated status, the nonr egulated status for MON 87769 soybean would incl ude MON 87769 soybean, any pr ogeny derived from crosses between MON 87769 soybean and conventiona l soybean, and crosses of MON 87769 soybean with other biotechnology-derived soybean th at have been determined to be no longer subject to the requirements of Part 340 or the plant pest pr ovisions of the Plant Protection Act. MON 87769 soybean is currentl y regulated under 7 CFR part 340.3 Interstate movements and field trials of MON 87769 soybean have been conducted under permits issued or notifica tions acknowledged by APHIS from 2003 through 2008. Data resulting from these field trials are de scribed in the petition (Monsanto, 2010b). Notifications acknowledged and permits issu ed by APHIS are listed in the petition (Monsanto, 2010b). The test sites represent dive rse regions of the U.S., including the major growing areas of the Midwest (Wisconsin, Mi chigan, Minnesota Missouri, Iowa, Illinois, Indiana, Kansas, Kentucky, Nebraska, South Da kota, Pennsylvania, Ohio, and Arkansas),

and winter nurseries in Puerto Rico a nd Hawaii. Field tests conducted under APHIS oversight allow for evaluation in agricultural settings under confinem ent measures designed to minimize the likelihood of persistence in the environment after co mpletion of the field trial. Under confined field trial conditions, data are gathered on multiple parameters and used by applicants to evaluate agronomic characteri stics and product performance. These data are also valuable to APHIS for assessing the potential for a new variety to po se 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 nonregulat ed status of MON 87769 soybean, a specialty trait soybean characterized by a fatty acid prof ile 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 c onditions. 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 ta ste) than fish oils, thereby expanding the potential formulation options for food companies and food products for consumers. The biosynthetic pathways for in terconversions of the linoleic, linolenic and SDA to EPA and DHA are shown in Figure 1.

SDA production in MON 87769 soybean is accomplis hed by inserting two desaturase genes, Primula juliae Δ 6 desaturase ( Pj.D6D) and Neurospora crassa Δ 15 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), anothe r fatty acid not in conventional soybean. In MON 87769, the Nc Δ 15D protein converts lin oleic acid (LA) to alpha- linolenic acid (ALA) and the protein Pj Δ 6D converts the ALA to SDA and LA to gamma linolenic acid (GLA) (Monsanto, 2010). Figu re 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 Δ 6 desaturase ( Pj.D6D) and Neurospora crassa Δ 15 desaturase ( Nc.Fad3) inserted into MON 87769 soybean form fatty acids.4 Source: Source: (Council for Responsible Nutrition, 2005).

Figure 1. Pathways for the synthesi s of EPA and DHA from Linoleic and alphaLinolenic Acid.

MON 87769 soybean would not be grown for the commodity soybean market; instead, it is anticipated that a specialty soybean o il from MON 87769 soybean would be produced. Compared to commodity soybean oil, SDA soyb ean oil contains two additional fatty acids, SDA and GLA. SDA omega-3 soybean oil pr oduced from MON 87769 soybean contains approximately 20 to 30% SDA (weight perc ent of total fatty acids), 5 to 8% gamma -linolenic acid (GLA), and sligh tly higher levels of alpha- linolenic acid (ALA) and palmitic acid than in conventional soybean oil (Mon santo, 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 involve d 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 pl ants 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 alternat ives 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 pr oducts, frozen dairy desse rts and mixes, grain products and pastas, gravies and sauces, m eat products, milk products, nuts and nut products, poultry products, processed fruit ju ices, processed vegetable products, puddings and fillings, snack foods, soft candy, and soups a nd soup mixes at levels that will provide 375 milligrams (mg) SDA per serving. Fish a nd 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 w ill have low production acreage (< 5% of total U.S. soybean acreage or up to 3 to 3.5 m illion acres) in North America. In order to derive commercial value from this produc t, 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 provi sions of the Plant Pr otection Act and 7 CFR part 340, APHIS has issued regulations fo r 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 ge netically 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 18:0

stearic

acid 18:1

oleic

acid Δ 9 18:3

α -linolenic

acid Δ 12

18:3

γ -linolenic

acid 18:2

linoleic

acid Δ 15

18:4

stearidonic acid Δ 6 Δ 6

Δ 15

Pathways where soybean’s existing desaturases form fatty acid

Pathways where desaturases introduced in MON 87 769 form fatty acids6 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 longe r subject the plant pest provi sions of the Plant Protection Act and 7 CFR part 340.

APHIS has prepared this environmental a ssessment (EA) to consider the potential environmental effects of an agency determina tion of nonregulated stat us consistent with Council of Environmental Quality’s Nati onal 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 evalua te the effects on the quality of the human

environment 1 that may result from a determinatio n of nonregulated st atus 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 pest icidal property, and, accordingly, is not regulated by the U.S. EPA.

1.6.2 Food and Drug Administration

FDA regulates GE organisms under the au thority of the FFDCA (21 U.S.C. 301 et seq. ). The FDA published its policy statement conc erning regulation of products derived from new plant varieties, includi ng those that are GE, in the Federal Register on May 29, 1992 (57 FR 22984). Under this policy, FDA implem ents a voluntary cons ultation 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 pl ant varieties, including those produced through genetic engineering. Monsanto initia ted the consultation pr ocess with FDA for the commercial distribution of MON 87769 soybean and submitted a safety and

nutritional assessment of food and feed deri ved from MON 87769 soybean to the FDA on March 23, 2009 (BNF No. 00117) (Monsanto, 2 010b). FDA is currently evaluating the

submission.

FDA also administers the Generally Recogni zed as Safe (GRAS) Notification Program (US-FDA, 2011). A substance that will be ad ded to food is subject to premarket approval by FDA unless qualified experts determine its use is generally recognized as safe

1 Under NEPA regulations, the “human environment” in cludes “the natural and physical environment and the relationship of people with that environment” (40 CFR §1508.14).7 (GRAS). Under the GRAS program (62 FR 18938), a notification procedure is established whereby FDA is notified by a pers on that they have made a determination that a particular use of a substance is GR AS. FDA evaluates the s ubmission to determine

whether a sufficient basis for a GRAS determin ation has been provide d 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 (US-FDA, 2009b). FDA issued a response letter on September 4, 2009, indicating the agency has no further questions about the char acteristics of the oil, and the safe ty of its use in foods (US-FDA, 2009a).

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 no tice 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. Th ese issues, including those regarding the agricultural production of soybeans usi ng various production methods and the environmental and food/feed safety of GE plan ts 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 M ON 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 cons idered in this draft EA we re 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 a nd unrelated lawsuits, as well as issues that have been raised by various stakeholders in the past. The res ource 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:8  Water Resources

 Soil and Land Use

 Air Quality

 Climate Change

 Animals

 Plants

 Gene Flow

 Microorganisms

 Biological Diversity

Human Health Considerations:

 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 Environment9 2 AFFECTED ENVIRONMENT

The Affected Environment section provides an overview of the use and composition of soybeans, followed by a discussion of the cu rrent 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 practi ces, the physical environment, biological resources, human health, animal feed, and socioeconomic issues. Because production of MON 87769 soybean is expected to be lim ited 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 include s the Northern Tier states of North and South Dakota, Minnesota, Wisconsin, and Michigan (Monsanto, 2010d) and a combination of geographically delimited seed sales, released maturity groups and soybean purchases, and contract s will provide a means to defi ne the production area.

2.1 Soybean Products and Composition

The soybean is an economically important leguminous crop providi ng oil and protein. Soybean plants are grown for their seed, whic h 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-base d 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 s eed 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 worl d soybean seed supply was traded to other geographies, with China, the European Un ion (EU), Japan, and Mexico being the top soybean seed importers (SoyStats, 2010h). Th e 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 yeas ts via fermentation to the manufacture of soaps, inks, paints, disinfectants, and biodiesel (see, e.g., (Cahoon, 2003); (SoyStats, 2010a)).

Soybean oil generally has a sm aller contribution to soybean’s overall value compared to soybean meal because the oil constitutes ju st 18 to 19% of the soybean's weight. Nonetheless, soybean oil accounted for appr oximately 30% of all the vegetable oils consumed globally and was the second largest so urce of vegetable oil worldwide, slightly behind palm oil representing approximately 32% of global consumption (Soyatech, 2010). Soybean oil also has industrial applic ations, includin g feedstock in manufacture of inks, paints, varnishes, resins, plas tics, and biodiesel ((Cahoon, 2003); (SoyStats, 2010a)). Soybean meal is used as a supplemen t in feed rations for livestock. Soybean10 meal is the world's most important protei n feed, accounting for nearly 69% of world protein meal supplies (SoyStats, 2010f).

Soybean is grown as a commercial crop in mo re than 40 countries (those with greater than 10,000 hectares) (FAO, 2010). Processed s oybeans supply the largest world source of protein animal feed and the second la rgest source of vegeta ble 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, sunflowe r 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 Amer ican livestock industry (USB, 2011a). The mixed rations for poultry, hogs, cattle, dairy co ws, domestic pets, and farmed fish often are formulated with soybean meal. In 2010, poultry were the la rgest 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 vegeta ble oil worldwide (USDA-ERS, 2010e). Since 2005, palm oil has overtaken soybean oil in volume of worl dwide vegetable oil production (USDA-ERS, 2010e). Conventional soybean o il is composed of a mixture of fatty acids. Fatty acids

are identified based on the numbe r of carbons and the degree to which they are saturated. Table 1 presents the fatty aci d composition of soybean.

The five major fatty acids in conventional soybean oil are linole ic acid, oleic acid, palmitic acid, linolenic acid, and stearic acid (CODEX, 2010). Linoleic and linolenic are classified as polyunsaturated fa tty acids, oleic acid is a m onounsaturated fatty acid, and palmitic and stearic acids are sa turated 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 aci ds, 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 b een used to decrease the percentage of polyunsaturated fatty acids in the soy oil blend (US-F DA, 1996). The selective hydrogenation dramatically improves shelf life and provides stability during deep-frying and other high temperature applications (Mozzaffarian et al., 2006). Although the11 hydrogenation process does increase the percen tage of monounsaturat ed oleic acids, the hydrogenation process produces substantial quantit ies of the trans isom er of oleic acid.

Such trans-fats have been identified as ne gatively impacting human cholesterol levels by raising the low-density lipoprotein (LDL) cholesterol and lowe ring the high-density lipoprotein (HDL) cholesterol. This association with trans-fa tty acids has resulted in a decline in soybean oil consumption in the U.S. (USDA-ERS, 2006a).

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 th e 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 detectable12 Soybean Food Products

Soybean is used in various food products, in cluding tofu, soybean sauce, soymilk, energy bars, and meat products. A significant fracti on 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).

2.1.2 Soybean Composition

Generally, soybean seed consists of oil (about 20%), protein (a bout 40%), carbohydrate (about 35%), and ash (about 5%) (Liu, 1997)Vari ous 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 rout ine heating of the protein or meal fraction during processing for animals or humans. The oil fraction is compos ed 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 hu man diets and feeding of livestock, poultry and farmed fish. The carbohydrate fraction of soyb ean 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 th at 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 meta bolism from other nitrogen containing precursors (Kuiken and Lyman, 1949). The essential amino acid composition of soybean and soy-based products is provided in th e 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 th ey exhibit estrogenic activity similar to estradiol hormones (Rostagno, 2009). These is oflavones may provide both benefits and negative impacts, as they are variously reported to exhibit estrogenic and anti-estrogenic effects, influence cardiovascular disease, im pact cancer rates, and possibly slow the rates of osteoporosis. The major soybean isof lavones include genistein and daidzein. Isoflavones are produced primar ily by beans and other legu mes 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 isof lavones are those that have13 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 f ood product which may be toxic at high concentrations, bind nutrients, or otherwise prevent their digestion. Soybeans contain several key antinutrients, such as oligosacch arides, lectins, phytic acid, and protease inhibitors (OECD, 2001). Prot ease inhibitors include tryps in and chymotrypsins (OECD, 2001). Lectins are sugar-binding protein inhibitors. The activity of thes e 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 soybea n, preventing its absorption by an animal. It is common practice to add phytic acid-degrading enzymes to the animal feed formula (Monsanto, 2010c). Protease inhibitors interf ere with the digestion of proteins, resulting in decreased animal gr owth (OECD, 2001). The antinutrients are destroyed during the heat tr eatment processing of the s oybean 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 (Mic ha and Mozaffarian, 2010)). Polyunsaturated fatty acids in soybean include linoleic and linol enic, 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 carbohydrat e) (Micha and Mozaffarian, 2010). When monounsaturated fatty acids (e.g., oleic acid) replace saturated fatty acids, effects are uncertain because of mixed evidence at pr esent (Micha and Mozaffarian, 2010). Transfats in the diet are unhealthy; these are produced when soybean fatty acids such as linolenic and linoleic are subjected to hydrogena tion because of inherent low stability, or because properties of soybean oils are unsuita ble for certain food uses . Incorporation of resulting trans-fats in foods result in know n undesirable effects on blood lipid parameters (lowering HDLs, increasing triglycerides, and increasing LDLs). In turn, these measured parameters of human health co rrelate 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 soyb ean meal (Monsanto, 2010b). Soybean is ranked number one in oil production (58 perc ent) among the major oil seed crops production in the world (ASA, 2011). Recen tly, there has been an increase in the percentage of the crop dedicate d to specialty soyb ean produced for a specific market or14 use. These specialty, value-added products ma y be the whole bean or a fraction, such as the oil (Lee and Herbek, 2004). The production of specialty s oybean 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 geogr aphies 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 (U SDA-NASS, 2011a). At least 31 states grew soybean as an annual crop in 20 10 (USDA-NASS, 2011a). For the 2010 growing season, more than one million acres of soybean s were grown in each of the following 18 states (from highest to lowest acreage): Io wa, Illinois, Minnesota, Indiana, Missouri, Nebraska, Ohio, Kansas, South Dakota, Nort h Dakota, Arkansas, Michigan, Mississippi, Wisconsin, North Carolina, Tennessee, Kentuc ky, and Louisiana (USDA-NASS, 2011a). Harvested soybean is projected to slightly increase to nearly 80 million acres by 2020 (USDA-NASS, 2011b; USDA-OCE, 2011).

Although soybean acreage has increased fr om 2005 to 2010 by about 7% (USDA-NASS, 2011a), the potential for an increase into uncu ltivated 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 hi gh 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 th at 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 ot her developed areas (EIA, 2007). It is unlikely that “new” previously uncultiva ted land will be brought into soybean production, but rather that gr owth of soybean producti on will compete with other agricultural uses (EIA, 2007).

Genetically modified plants, including s oybeans, have been widely planted, with increasing frequency after their commercial in troduction in the late 1990s. GE soybeans currently are planted on the majority of soyb ean acres in the U.S. (93% of acreage in 2010) (USDA-ERS, 2011a). All these GE s oybean varieties are he rbicide resistant. Besides genetically modified soybean varie ties with crop production traits, such as herbicide tolerance, varieties expressing altere d 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-transge nic products, but new GE va rieties are being developed (Cahoon, 2003).

Monsanto plans to channel production of SDA soybean into a limited region using several strategies identified below (Mons anto, 2010d). 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 meas ures are currently used in the production of specialty soyb eans, including contracts sp ecifying details of production15 and sales between growers and soybean purch asers (see second bulle t). 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 loca l season. Day length, temperature and length of the growing seas on 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, s oybean yield, and therefore, commercial value, is a consequence of th e 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 deve loper. These businesses would have compartmented storage available for speci alty oilseed crops, and would agree to conditions specified in Monsanto’s manage ment plan, which would be required for segregating the crop. If soyb ean buyers are located too dist ant 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 th at states located in the northern U.S. provide the optimal environment for ma ximal expression of SDA from MON 87769 soybean (Monsanto, 2010b).

Through these means, Monsanto will be ab le to limit where growers produce MON 87769 soybean which will be the states of North and South Dakota, Minnesota, Wisconsin, and Michigan (Monsanto, 2010d). 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 fe rtile soils (McKnight, 2004). Corn, soybean, alfalfa, hay, fruit, beef cattl e, hogs and dairy cattle are produced here. The other area where Monsanto plans to ta rget production of MON 87769 s oybean 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 (McKni ght, 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 a llow vegetable and fruit producti on 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 Ag riculture (USDA-NASS, 2009) Note: *Wheat, forage and so ybean acreage nearly equal

2.2.2 Agronomic Practices

In this EA, “conventional farming” incl udes any farming system where synthetic pesticides or fertilizers ma y be used. Conventional farm ing covers a broad scope of farming practices, ranging from farmers who only occasionally use synthetic pesticides

and fertilizers to those farmers whose harves t depends on regular pesticide and fertilizer inputs. Conventional farming also includes the use of genetically engineered (GE) varieties that are no longer s ubject to the regula tory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act.

Soybean self-pollinates and is propagate d by seed (OECD, 2000). Proper seedbed preparation, appropriate variety selecti on, appropriate plantin g dates and plant population, and good integrated pest management practices are important for optimizing17 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 separa ted 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; Hodge s and French, 1985; Pioneer, 2011). To adapt to the local growing season, producers typically plant seed of an appropria te maturity group so that its development and harvest coordinate s 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 ma turing 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 Wisc onsin Extension (UWExtension, 2008 ) has tested maturity groups between 0.1 and 2.8 in various parts of Wisconsin to match local conditions. In part s of Michigan, a maturity group as high as 3.4 might be planted (MSU-Ext ension, 2010) and in parts of North Dakota 00 or even 000 might be planted (Kandel, 2008).

Pre-Season Preparation

Crop rotation, tillage system, ro w spacing, planting equipment, se ed or trait selection(s),

herbicide choices and details of soil fertility require produc tion decisions well in advance of planting the soybean crop.

Planting and Early Season

Adequate soil moisture and warm temperatur es facilitate rapid seed germination and emergence. Planting date has the greatest im pact on yield (Hoeft et al., 2000). Soybean can germinate at a soil temperature of 50 degr ees Fahrenheit (oF) wh en planted at a depth of two inches, with the ideal soil temperatur e 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 Wisc onsin planting as late as June 20 (USDANASS, 1997). As an example, in Wiscons in, although the highes t yield comes from planting before May 20, delayed planting to Ju ne 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 Rea dy Soybean (NDSU Weed Science):18  Strategy 1: Pre-emergent herbicide or pre-plant incorporated metolochlor, pendimethalin, Fierce, or metribuzin, etc. used. Most require rain for activation.

 Strategy 2: Glyphosate applie d to early emerged weeds.

 Strategy 3: Glyphosate app lied to 2-4 inch weeds. For tillage practices in early se ason, 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 beginn ing 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 s oybean plant to have 75% of its flowers fail to develop a pod (Monsanto, 2010b; Scott and Aldrich, 1970).

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

 Strategy 1: Glyphosate applied to soyb ean post-emergent (follows early preemergent soil-applied or -incorporated herbicide).

 Strategy 2: Post emergent herbicid e acetochlor, imazamox, bentazon/sethoxydim, acifluorifen (follows glyphosate appl ied pre- emergent to soybean).

 Strategy 3: Roundup/glyphosate 14-21 days after first application (follows glyphosate applied to pr e-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).19 Recommended fall herbicide use in Roundup Re sistant Soybean for next season soybean (MSU, 2011):

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

 2: Burndown with residual activity: Au thority Assist, Canopy, Autumn, Extreme.

Crop Rotation

Soybean crop rotation is an important ma nagement practice for managing weeds, to control volunteer soybeans, and to limit the pot ential for weeds to develop resistance to herbicides (e.g., glyphosate-resi stant 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 s oybean 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, 2010c) at page 157, et se q.). 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 acr eage, with cotton, rice, and sorghum the next largest rotationa l crops following soybean (4.6% of the soybean acreage). Other minor rotational crops that follow soybean pr oduction 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 corn-soybean adapted Diabrotica species (corn rootworm), soybean cyst nematode, and weeds that proliferate in soybean and corn (Anderson, 2008). In southwestern Michigan, increa sing crop diversity in crop rotations has been shown to20 increase corn grain yield (Smith et al., 2008) . Double cropping (i.e., plantings two crops in the same field within one year) of s oybean with wheat is discouraged, since a predictable rate of return on late planted soybean cannot be established (Conley et al., 2008).

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 co mmunications with state ex tension specialists and Monsanto Technology Development Representa tives (Monsanto, 2010c).

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 conven tional tillage, made up the remainder. Conservation tillage practices have seen in creased 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 categor ies, 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 till age is associated w ith intensive plowing and less than 15 percent crop residue; reduced tillage is associated with 15 to 30 percent crop residue; and conservation tillage, includ ing no-till practices requiring herbicide application on the plant residue from the previous season, is associated with at least 30 percent crop residue and subs tantially less soil erosion than other tillage practices (USEPA, 2009). Almost 40% of full season soybean acreage is under no-till practice, while another 23% is under a speciali zed type of conservation tilla ge. Another 20% of soybean acres are intensively tilled.

In addition to preplant tillage preparati ons, cultivation for weeds might also be undertaken because a preplant residual herb icide was not activated by precipitation, and immediate control is required (IPMCenters, 2011). Pre-emergence herbicides may also21 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 shallo w cultivation (IP MCenters, 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 a bout 35% of that originating fr om soil (Hoeft et al., 2000). The remaining nitrogen needs of soybean co me 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 form ation of root nodules, providi ng an environment in which

differentiated bacteria reduce or fix atmo spheric nitrogen. The product of nitrogen fixation, ammonia, then can be used by the plant (Gage, 2004). USDA-ERS (USDAERS, 2010e) estimates that less than 40% of soybean acres in the U.S. receive nitrogen fertilizer. Given the important role of th ese 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, supplem ental nitrogen may be required for the developing crop (Ferguson et al ., 2006). Maintaining an op timal pH is important to proper initiation of nodulation, and in a typica l 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 re mained an important strategy (Gunsolus, 1990). By the early 1990s, there were over 70 individual herbicides or combination products registered for weed control in s oybean (Gianessi et al., 2002). As additional herbicides became available, the possibility of the conservation-enhancing use of reduced tillage or no-till became feasib le (Givens et al., 2009). Next , as herbicide-tolerant GE

crops were no longer subject to the regulatory re quirements 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 ti llage 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 better22 management than tillage alone (Gianessi a nd Reigner, 2007). Consequently, as noted, there has been a trend towards less tillage as a greater number of herbicide choices and options have become available. As herbic ide-resistant crops were offered and deployed,

increased amounts of conservati on tillage began to be practi ced, since particularly wide spectrum herbicides (such as glyphosate) c ould be used on soybean. Although herbicidetolerant varieties have become the most widely planted soybean in the U.S. (94% of all soybean acreage in 2011 (USDA-ER S, 2011a)), especially Roundup Ready ® varieties, the developer of the technol ogy still recommends that gr owers add tillage or other herbicides, as appropriate, in their Roundup Ready ® soybean production methods (Monsanto, 2011).

Foxtail spp., pigw eed, 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 problema tic weeds in corn and soybean because of the difficulty of controlling these weeds (Ni ce and Johnson, 2005). For Minnesota soybean, yellow foxtail, common ragweed and common la mbsquarters are prominent, with winter annuals such as mustards, horseweed, and bi ennials such as wormwood important weeds; perennial broadleaf weeds include Canada thistle, common milkweed and hemp dogbane which can be difficult to manage in soyb ean (Potter and Ostlie, 2003). Eighty-six common weeds of soybean across three gr owing regions (Midwest, Mid-South, and Eastern Coastal) were identif ied in another soybean pet ition 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 glyphosatetolerant soybean varieties, and applying gl yphosate at least once during production. In some places glyphosate resistant weeds have been reported, such as pigweed and morning glory (Heatherly et al., 2009; Woodruf f 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 sp acing, and mechanical remova l of weeds (Woodruff et al., 2010). In 2002, it was calculated that 96 perc ent of all planted s oybeans 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 pe rcent of soybean acres of surveyed states (USDA-NASS, 2007b). Table 5 shows principl e herbicides used on soybean in two Northern Tier states. Weed species ar e 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 O ffice (USDA-NASS_Wisconsin-Field-Office, 2009 download). ** Minnesota Department of Agriculture (MDA, 2009).

Various other pesticides may also be used for soybean production, in cluding insecticides, fungicides, and nematicides. In 2006, insec ticides were used on 16 percent of soybean

acres. The three most common insecticid es, lambda-cyhalothrin, chlorpyrifos, and esfenvalerate, were applied to 6, 5, and 3 pe rcent 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) Breed er; 2) Foundation; 3) Registered; and 4) Certified (see, e.g., (M CIA, 2009, 2010)). Each class of seed is identified to designate the seed generation fr om 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 licens ees, such as seed companies (Adam, 2005). Registered seed is used by seed companies to produce large quantitie s of Certified seed (Adam, 2005; Hartman and Kester , 1975). The Certified (or Sel ect) seed is then sold to growers through commercial channels (Ada m, 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 eff ects upon seed production are not carefully controlled, the value of a new vari ety or cultivar may be lost (Hartman and Kester, 1975). Genetic purity in commerci al seed production is generally regulated through a system of seed certification which is in tended to ensure that the desired traits in the seed are maintained throughout all stages in cultivation (Hartman and Kester, 1975).

States have developed seed la ws 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. Fe deral Seed Act of 1939 recognizes seed

certification and offici al certifying agencies. Implemen ting regulations further recognize land history, field isolation, and varietal purity standard s for Foundation, Registered, and

Certified seed.24 Foundation seed, Registered seed, and Certif ied seed production is controlled by public or private seed certification programs (AOS CA, 2009). Commercially certified soybean

seed must meet state and Federal seed standa rds and labeling requirements. Federal Seed Act regulations are detailed in 7 CFR 201. St ate seed certification standards may vary slightly from state to state a nd can be more restrictive than the seed standards of AOSCA (Association of Official S eed 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 o ff-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 st andards 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 di fferent type, certified seed of the same variety, or a variety having no ticeable characteristic differe nces. In addition, for every 200 certified soybean plants, only one off-t ype or other variety is allowed (AOSCA, 2009). Certified seed crop is subject to fiel d 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 distingu ished from identity preservation systems for certain agricultural commodities. Soybean Identity Preservation (IP) refers to a system of production, handling, and marketing practices th at 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 sp ecific methods and certified under the USDA’s Agricultural Marketing Service (AMS) National Organic Program (NOP) definition of organic farming can be market ed and labeled as “organic” (USDA-AMS, 2010). Organic certification is a process-based certification, no t a certification of the end25 product; the certification pro cess specifies and audits th e methods and procedures by which the product is produced.

In accordance with NOP, an accredited orga nic certifying agent conducts an annual review of the certified operati on’s organic system plan and makes on-site inspections of the certified operation and its r ecords. Organic growers must maintain records to show that production and handling procedures co mply 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 or ganic”, “organic” or “made with organic (specified ingredients or group(s)),” th e product must be produced and handled

without the use of:... (a) Synthetic substanc es and ingredients,... (e) Excluded methods,...

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

A variety of methods used to geneti cally modify organisms or influence their growth and development by means that are not possible under natural conditions or processes and ar e 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 ferti lization, or tissue culture.

Organic farming operations, as described by the NOP, are required to have distinct, defined boundaries and buffer zones to pr event unintended contact with excluded methods from adjoining land that is not unde r organic management. Organic production operations must also develop and maintain an organic production system plan approved by their accredited certifying ag ent. This plan enables the production operation to achieve and document compliance with the Na tional Organic Standards, including the prohibition on the use of excl uded methods (USDA-AMS, 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 car ried between the fields (Baier, 2008; Bradford, 2006; NCAT, 2003; Sundstrom et al., 2002).

Although the National Organic Standards prohib it the use of excluded methods, they do not require testing of inputs or products for the presence of excluded methods. The26 presence of a detectable residue of a product of excluded methods alone does not necessarily constitute a viol ation 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 produc t. 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 cont act with the products of excl uded methods as detailed in their approved organic system plan (R onald and Fouche, 2006; USDA-AMS, 2010).

The production of organic soybeans represen ts 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, approximatel y 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 sy stem of production, handling, and marketing practices that maintains the integrity and pur ity of specialty crop products (Sundstrom et al., 2002). Commodity grains are market ed en masse according to USDA grading standards. Specialty crops requi re some form of segregation or IP to keep these grains separate from commodity grai ns (Elbehri, 2007). This se gmentation helps preserve a specified purity of the product. With certa in specialty crops (e.g., organic or designated industrial-uses), IP is requir ed to prevent accidental or un intended commingling. Should27 the IP crop be admixed with a different variety, contracts between growers and purchasers define acceptable limits of such admi xture. If defined purity is not attained, the buyer can reject the crop, and the grow er would not receive the premium price specified by the contract. Thus, financial pe nalty encourages the grower to maintain standards expected by the buye r and by those users further along in the supply chain.

Comments submitted in previous environmental assessments have identified issues pertaining to management practices desi gned to prevent accidental or unintended commingling of crops. Many of these prac tices are already well established in the soybean industry as part of the crop cultivat ion 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 (Sunds trom et al., 2002). MON 87769 soybean is expected to be handled and ma rketed within the practices of a Closed Loop IP production system (Monsanto, 2010b).

Specialty Soybean Types

The U.S. soybean IP produc tion and distribution systems accommodate differences between commodity an d specialty soybean. Production systems designed prior to the introduction of MON 87769 soybean or ev en prior to the introduction of biotechnology-derived soybean allow for producti on of specialty soyb ean varieties to

meet varied customer dema nds. Although soybeans are pr imarily a commodity crop, there is an existing specialty soybean marke t. 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 se veral broad categories (Monsanto, 2010c; 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 charact eristics such as altered seed composition (e.g., low saturated fat, high sucrose, high oleic, low linolen ic, and high protein),28 varieties of soybean with unique physical ch aracteristics suited to their specific uses (e.g., clear hilum for direct human c onsumption), or refer to a production process (e.g., organic, certified seed). The cate gories are not meant to be exclusive; for example, soybean used to produce natto or tofu may employ organic production processes. Moreover, soybeans of all spec ialty categories are often derived from varieties produced according to certifie d 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 si ze (Lee and Herbek, 2004). T ofu varieties also must be high in protein (40% or higher) and low in oil concentration compared with commodity soybean. Clear hilu m (i.e., the small scar ma rking the seeds former place of attachment to the pod) and other character istic are required for soybean used in the production of other soybean food products cons umed 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 va rieties are offered in Maturity Group II and early Group III varieties which are adap ted to the upper Midwest/Great Plains region (Lee and Herbek, 2004). Vistive ® soybean with low linolenic traits are offered by Asgrow in Maturity Gr oups 2.0 to 3.6 (Asgrow, 2011).

Specialty Soybean Production

Specialty soybean varieties are specifie d by buyers and end-users of soybean for production, and premiums are paid for deliv ering a product that meets purity and quality standards for the soybean variety. Product differentiation and market segmentation in the specialty soybean industry includes mec hanisms 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 s oybean and the specia lty 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 ma rketed as a commodity for the oil and protein markets (Monsanto, 2010c). The goal of th e commodity supply chain is to supply a homogenous product to the end user. Al though 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, 2010c).

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 ha ve 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 different29 sources of soybean. The beneficial conse quence 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 ha s 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 soybean s that have specific physical or chemical characteristics to meet specific buyer requirement s. As a result of th ese special needs, a separate specialty soybean channel has deve loped for the specialty soybean product that involves much smaller volumes than commodity soybean (Smyth and Phillips, 2002; Sonka et al., 2004). Specialty soybean vari eties 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 acreag e 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 non-GE crops or for seed production (Goldsmith et al., 2008). Fehr (2007) repor ted that in 2006, about 700,000 acres in the U.S. were planted to low and ultralow linolen ic acid varieties (Fehr, 2007).

The specialty soybean supply chain typically star t with a firm that c ontracts 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 contract s may require a special insp ection 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 vegetabl e soybean) (Ernst and McNulty, 2011 download).

For specialty soybean, weed control is ex tremely 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 with Altered Fatty Acids

The genetic changes in soybeans that result ed in altered soybean oil composition have been achieved by both conventional and genetic engineering techniques . Varieties were improved conventionally by genetic selecti on 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). Conventional soybean breeders also

have obtained varieties with greater than 70% oleic acid by selection and intercrossing (Alt et al., 2005).30 Nontransgenic lines include those which expr ess low linolenic acid, an oil trait which does not require trans-hydrogenation to impr ove 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 ha s made some lines available to growers (http://www.notrans.iastate.edu/). Low satura ted fat soybeans are also available from Iowa Natural (1% linolenic, 7% saturated fats of total oil) (Ameri can Heart Association, 2011; NYC-DOH, 2009). Low linolenic soybean s with GE herbicide tolerance are marketed by Monsanto (‘Vistive’) and Pioneer (‘Plenish’) seed companies, with linolenic acid expressed at less than 3%. The Vistiv e line was planted on 1.5 million acres in 2008 (Monsanto, 2008).

Genetic engineering techniques have been us ed to increase oleic acid composition in soybean to near 80%, but the first altered fatty acid vari ety no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pe st 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 phenot ype conferred by in troduction of the soybean omega-6 desaturase gene 1 ( fad2-1 gene) was no longer subj ect to the regulatory requirements of 7 CFR part 340 or the plant pe st provisions of the Plant Protection Act, but will not be released commercially un til 2012 (Plenish (Pioneer Hi-Bred, 2011)). Other 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 va rieties (conventional, nontransgenic) in the U.S. were planted on approximately 8% of the total soybean acres in 2008 (FernandezCornejo et al., 2002), and many of these are specialty soybeans (Lee and Herbek, 2004). Specialty soybean varieties in clude tofu, natto, bean sprout s, edamame, soynuts, as well as those with unique chemical identities, such as those with modified fatty acid profiles, high protein or high sucrose cont ent. 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 w eed 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 s oybean crop is approximately 20 inches during the growing seas on (Hoeft et al., 2000). A nnual state-wide precipitation data collected for the 5-state region wh ere MON 87769 soybean may be grown (i.e., North and South Dakota, Minnesota, Wi sconsin, 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 may31 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 cultiv ated (USDA-NASS, 2007c, 2010 ). In some limited areas, such as central Mi nnesota, 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 acr es that are irrigated are a small portion of total soybean acres, much less than those acr es irrigated for corn (Table 7) (USDANASS, 2007c).

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

State Harvested acres a Irrigated harvested

acres b,c Percent

of soybean

acres irrigated c 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

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 Highlig hts: 2007 (USDA-NASS, 2009)

b. Source: Soybean Irrigated Harvested Ac res: Table 33, 2007 Census of Agri culture – State Data (USDA-NASS, 2007c)

c. Total acres from (USDA-NASS, 2007c).

In most states, irrigation water comes pre dominantly from groundwater sources, with in comparatively little derived from su rface water sources (Table 8).32 Table 8. Water sources used for irrigation of soybean acres in Northern Tier states.

State Irrigated

harvested soybean acres a Water Source a
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 Surv ey 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) polluti on is the primary source of discharge pollutants to rivers and lakes and a major c ontributor to groundwat er contamination. Management practices that contribute to NPS pollution include the type of crop cultivated, plowing and tillage, and the a pplication of pesticides, herbicides, and fertilizers. Agricultural pollutants released by soil erosion include sediments, fertilizers, and pesticides that are introduced to area lake s 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 mortalit y and reduce the amount of light penetration into a body of water. Indirectly, soil erosi on-mediated sedimentation can in crease fertilizer runoff, and facilitate algal blooms and oxygen deplet ion 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 concentrations, may lead to eutrophication of surface water, resu lting in changes in dissolved oxygen concentrations and freque nt 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 we re detected by Voge l et al. (2008) in rainwater, such as chlorpyrifos (64% of samp les in a four state pa ttern). In addition to direct impacts to surface water, agricu ltural chemicals may eventually impact groundwater when transported by infiltrating surface or irrigati on water. Irrigation with locally pumped water tends to reduce transpor t of chemicals in ground water because it avoids connecting streams with gr oundwater (Domagalski et al., 2008).33 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 princi ple 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 syst ems 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 em ployed (Hoeft et al., 2000).

Conservation tillage and no-till practice ha ve 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 c onsequent 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 th e below-ground community, plant root suture, and organic residues in the soil is central to a variet y of dynamic soil ecological processes, including the decom position of organic material, s ubsequent nutrient cycling and release, and the associated mainte nance of soil structure and composition.

Soil Type

Soil texture and structure are key components determining wa ter availabili ty 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’ me dium size, good aeration, fertility, high waterholding capacity and abundance of organic ma tter make it the ideal soil for soybean cultivation (Hoeft et al., 2000). As medium-tex tured soils are able to hold more available water, the soybean roots in medium textured soils are denser and ex tend 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 te ndency to clump and impede drainage when tilled at too low or too high moisture leve ls, leading to less aer ation 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)

The soils found in the Northern Tier states are of varying types but predominately Mollisols and Alfisols. Soil surface layers of Mollisols are generall y 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 ben eath a surface layer of relatively high fertility (McD aniel, 2011; Soil Survey Staff, 1999, 2010; US-EPA, 2009). Additionally, another type of so ils found in the five states of interest are Vertisols which34 are clay soils that expand when wet and sh rink 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 mechan ized harvesting machinery may disturb and expose the top soil surface layer, leaving th e land prone to degradation. In turn, degradation of soil st ructure and composition may lead to decreased water retention, a decrease in soil carbon aggregation and ne t positive carbon sequestration, and increased emission of radiatively-active gases that cont ribute to the greenhouse effect (e.g., carbon dioxide (CO 2 ) and nitrous oxide (N 2 O)) (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 fi xes a significant portion of its own nitrogen through the symbiotic relationshi p with the nitrogen-fixing Bradyrhizobia bacteria ( Bradyrhizobium japonicum ) that live in soybean root nodul es (Hoeft et al., 2000). The soybean root nodules contain colonies of bact eria which take gaseous nitrogen from the atmosphere and fix it in forms easily used by the soybean plant. Because the nitrogenfixing bacteria are not native to U.S. soils a nd would not normally be found in these soils, soybeans are frequently inoculated with thes e bacteria prior to pl anting, especially if soybean has not been grown in a field fo r 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 nutri ents and water (Purves et al., 2004). In addition to increasing soybean access to wa ter and nutrients, mycorrhizal hyphae also facilitates pore creation in so il 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. Mycorrhizalcolonized non-irrigated soybean s have shown a 10 percent incr ease in yield compared to non-colonized non-irrigated soybeans during a drought period. These two mutualistic symbioses have been shown to occur conc urrently, with mycorrh izae having a positive impact on Rhizobium nodulation and the nitrogen-fixi ng activity of nodules present on the soybean plant. These soybean plants al so provided a greater yield (Heatherly and Hodges, 1999).35 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 allerg ens. The seven NAAQS criteria pollutants are carbon monoxide (CO), l ead, nitrogen dioxide (NO 2 ), particulate matter between a nominal 2.5 and 10 micrometers in aerodynamic diameter (PM 10 ), particulate matter less than a nominal 2.5 micrometers in aerodynamic diameter (PM 2.5 ), ozone (O 3 ), and sulfur dioxide (SO 2 ) (US-EPA, 2010c). The main GHGs th at enter the atmosphere because of agricultural activities include: carbon dioxide (CO 2 ), methane (CH 4 ), and nitrous oxide (N 2 O). In addition to CO 2 , ammonia is also another trace ga s 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 oxi des, reactive organic gases, particulate matter, and sulfur oxides (US-EPA, 2010b). Ag riculture activities (e.g., field preparation, planting, and harvesting) may generate dust plumes (PM 10 and PM 2.5 ) (Holmén et al., 2006). For example, peak levels of particul ate 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 agricu ltural burning, pesticide drift from spraying; and aerial application of pest icides which all may cause air quality impacts by drift and diffusion. Atmospheric wet and dry deposit ion of nitrogen, mineral nutrients, and organic compounds to cropping systems can have feedback effects on trace gas emissions from fields (Krupa et al., 2006). Agricultur al pesticides may also enter the atmosphere through volatilization from soil and plant su rfaces 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: CO 2 from agricultural burning; vehicle exhaust associated with eq uipment used in tillage and harvest; and N 2 O emissions from the use of nitrogen fertilizer(Aneja et al., 2009; Hoeft et al., 2000; USEPA, 2010a; USDA-NRCS, 2006a). Agricult ure, including la nd-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 pract ices 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 fe deral levels, but for most GHGs there are no applicable regulations of these gases arising from agricultural burning.36 Agricultural burning generates smoke that consists of pa rticulate 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 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, (Fra nzen 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 mo re 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 PM 2.5 , 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 PM 2.5 : three-county Milwaukee-Racine, WI area and the seven-coun ty Detroit-Ann Arbor, MI area (US-EPA, 2011b).

Greenhouse Gases

Primary agricultural air emissi on sources of GHG include: CO 2 from agricultural burning; vehicle exhaust associated with eq uipment 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). Ag riculture, 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, ar e the largest source of U.S. N 2 O emissions. Croplands account for 69% of the total N 2 O emissions attributable to agricultural land uses (US-EPA, 2010a).

 Carbon dioxide (CO 2 ) is also a significant GHG gas associated with several agricultural practices, including classe s of crops, location and soil types associated with the practices, and en ergy consumption (Col e et al., 1997; USEPA, 2010a).37 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, em issions of nitrous oxide, produced naturally in soils through microbial nitrification and deni trification, can be dramatically influenced by fertilization, intr oduction 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 agri cultural practices can influence the decomposition of carbon-contai ning organic matter sequestered in soil, resulting in conversion to carbon dioxide lo ss 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).

The EPA has also identified regional diffe rences in GHG emissions associated with agricultural practices on differe nt soil types, with high mi neral content soils responding to GHG differently than high- organic content soils (US-EP A, 2010a). Mineral soils contain from 1 to 6% organic carbon by wei ght; 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 atmosphe re (US-EPA, 2010a). In contrast, organic soils may contain as much as 20% carbon by weight (US-EPA, 2010a). When such organic soils are prepared for agricultur al use, the soils are aerated, accelerating decomposition and release of CO 2 to the atmosphere (US-EPA, 2010a).

Tillage, Fertilization and Greenhouse Gases. Ti llage contributes to the release of GHG

because of the loss of CO 2 to the atmosphere and the exposure and oxidation of soil organic matter (Baker et al., 2005). Herbicide-tolerant crop s may encourage increases in the adoption of conservation tillage pr ograms whose consequences may include reductions of many of these emission con cerns. Special conservation tillage field equipment can often perform the equivalent functions of several standard implements, reducing the necessity for multiple passes thr ough the field. Implementing CT practices can lead to both economic and production quality benefits, as well as having positive environmental impacts (USDA-NRCS, 2006b). T illage contributes to the release of GHG

because carbon is lost as CO 2 to the atmosphere, and because of exposure and then oxidation of soil organic matte r (Baker et al., 2005).

GHGs and Nitrogen Fertilizer. Nitrous oxide emissions are released following use of nitrogen fertilizer and the action of soil mi crobes 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 CO 2 , is emitted because of fertilizer use (Herro, 2008).

Because soybean is able to fix atmospheri c nitrogen by means of symbiotic nodulating bacteria, nitrogen fertilizati on is often not indicated as a good management practice (Rehm et al., 2001; Staton and Warncke, 2009) . Less than 40% of soybean acres across38 the U.S. receive fertilizer application, which is appreciably lower than other major crops, such as corn and cotton (USDA-ERS, 2010e ). Considering these observations and recommendations, soybean production is most likely not a larg e contributor to GHG emission through nitrogen fe rtilizer application.

Pesticide Application

Aerial application of pesticides may cause impacts from drift and diffusion. Pesticides may volatilize after application to soil or pl ant 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 depos ited 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 agricultu ral chemicals are re-deposited via rainfall.

The persistence of pesticides in the atmo sphere may be an air quality issue. Air concentrations of pesticides are typically greatest within the imme diate 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 pestic ides are applied by ground or aerial spraying or by mechanical a pplication to the plan t surface, chemicals move to their intended and unintended targ ets 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, met hod of application, and the atmospheric conditions at time of treatment. All these influence th eir concentration and ultimate fate (Carlsen et al., 2006 ).

2.3.4 Climate Change

Climate change represents a statistical change in c limate conditions, and may be measured across both time and geographic sp ace. U.S. agriculture may affect climate change through various facets of the crop cul tivation process. Combustion of fossil fuels in mechanized farm equipment, fertilizer application, and decompos ition 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 indire ct (e.g., agriculturalrelated soil disturba nce) sources of CO 2 , CH 4 , and N 2 O (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 CO 2 , CH 4 , and NO 2 , may lead to extensive climate change because of altered cycli ng between atmosphere, ocean and land and radiative forcing causing climate change (IP CC, 2007). The U.S. agricultural sector is identified as the second largest contribut or to GHG emissions, ranking only behind the energy sector (i.e., electricit y production, transportation, and related activities) (US-EPA, 2010a).39 Agricultural crop commodities may also aff ect dynamic geophysical soil processes, such as carbon turnover and sequestra tion, through tillage and crop ping system practices. In general, reduced/conservation til lage practices favor more st able and increased carbon sequestration in the agro-environment (Lal, 2011 ). The impacts of GE crop varieties on climate change are most likely dependen t 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 agricultu ral crop production. These potential impacts on the agro-environment and indivi dual crops may be direct, in cluding changing patterns in precipitation, temperature, and duration of gr owing season, or may cau se indirect impacts influencing weed and pest pr essure (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 ne w ranges, current agricultural practices may be required to 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 obs erved 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 impact s with improved cultivar s 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 declin ing 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 prev ent harvest). The changes in precipitation patterns would lead to crop losses, including soybea n, of up to 30% in 2030 and 65% in 2090 (Rosenzweig et al., 2002). Other modeling effo rts 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 s cenario (Schlenker and Roberts, 2009).

The cited models suggest that impacts of clim ate change (specificall y, an overall deficit in total soybean yield) would exert pre ssure 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 suggests that it would be Brazil, China and South America that would likely have large convers ions to soybean production in response to40 lower production efficiencies elsewhere in th e world. However, some areas of the U.S. that may experience decreased soybean yiel d may show small levels of increased production, such as the Midwest states (+1.7%), because of increased CO 2 stimulating plant growth and cultivars with improved wa ter use efficiency (H atfield et al., 2011b).

Future impacts might be mitigated by selection of varieties that showed decreased responses to the changed climate. As Betzel berger et al. (Betzelberger et al., 2010) note, cultivar sensitivity to parameters such as in creased ozone can have substantial deleterious impacts on soybean yield as well. Some tropi cal soybean is less susceptible than other

varieties to the increased O 3 that may typify future environmental concentrations, and the differences are measurable in several paramete rs 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 soyb ean lines may be produced that will resist decreased precipitation expected over some U. S. soybean growing ar eas. Finally, use of different maturity group soybean with higher yi eld potential may be possible, especially if early spring occurs and the growing season is lengthened, and this and other management strategies could recover possibl e yield losses (Kucharik, 2008). From an analysis (Goldblum, 2009) of climate cha nge 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 spring and fall (producing increased pr ecipitation) versus increased temperature in summer (along w ith drought) may produce opposite impacts on soybean yield, and empirical evidence is n eeded to establish overall impacts of the anticipated variations (Kucharik, 2008).

2.4 Biological Resources

This section provides a summar y 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 move ment, 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 gees e, squirrels, other rodents (s uch 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 fi elds 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 ha ve a diet containing si gnificant amounts of41 soybean seeds. Migratory birds feed on spill ed 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 a nd corn fields in the Dakotas (Gamble et al., 2002).

The biodiversity of insect pr edators 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 pl ants provided greater “bioc ontrol services ” than does soybean (Gardiner et al., 2009). Total insect diversity in GE glyphosate tolerant soybean has been compared to that in non-GE soybea n, 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 problema tic than weeds in U.S. soybean production; nevertheless, insect injury can impact yield, plant maturity, and seed quality. Consequently, insect pests are managed duri ng the growth and deve lopment 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 th at receives an insecticide treatment(USDANASS, 2006).

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 re gion. In certain areas, soybean fields may be bordered by other soybean varieties, corn, or other crops. In addi tion, fields may also be surrounded by woodlands and/or pastur e/grassland areas, as well as aquatic environments. Therefore, the types of ve getation, including th e variety of weeds, adjacent to a soybean field depend on the area where the soybean is planted. Annual weeds are perceived to be the grea test 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 s oybean for light, nutrients, and soil moisture. Weeds can harbor insects and diseases, and al so 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, 2010c). The time period that weeds compete w ith the soybean crop in fluences the level42 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 plante d in narrow rows.

Eighty-six common weeds of soybean across th ree growing regions were identified inanother soybean petition for nonregulated status ((Monsanto, 2010c) Tables XI-5 and XI6). Foxtail spp., pigweed, velvetleaf ( Abutilon theophrasti ), lambs quarters ( Chenopodium album ), and cocklebur ( Xanthium strumarium ) are common annual weeds in Midwest corn and soybean fields. Ho wever, growers consider giant ragweed ( Ambrosia artemisiifolia ), lambs quarters, Canada thistle ( Cirsium arvense ), cocklebur, and velvetleaf to be the top five most probl ematic weeds in corn and soybean because of the difficulty to control these weeds (Nice and Johnson, 2005).

Crop rotations and environment have a si gnificant impact on the adaptation and occurrence of weeds in soybean. Cultural a nd 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, 2010c). Although the primary purpose of tillage is for seedbed preparation, tillage is still used to supplement weed c ontrol with selective herbicides in soybean production.

Herbicides provide effective and econo mical control of weeds in soybean. Approximately 98% of the soybean acreage re ceived an herbicide application in 2006, indicating the importance of weed control in maximizing soybean yield (USDA-NASS, 2007b). Herbicide-tolerant soybean was intr oduced to provide grow ers with additional options to improve crop safety and/or impr ove 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 th e standard weed control program in U.S. soybean production. In the 2006 crop year, fo r the surveyed states, 92 percent of the planted soybean acres we re treated with glyphosate (USDA-NASS, 2007b).

2.4.3 Gene Flow and Weediness

Gene flow has been defined as the “incorpor ation of genes into the gene pool of one population from one or more populations” (S tewart, 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 (USDA-APHIS, 2010a); it does so when specific genes with plant pest potential are incorporated into a cultivated plant. Ther e are two types of gene flow:

horizontal and vertical. Hori zontal gene flow is the movement of genes between disparate, unrelated species, such as between plants and microbes or between plants from43 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 betw een 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 hybri d (Stewart, 2008; USDA-APHIS, 2010a). Hybridization is usually thought of as the bree ding 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 spec ies or subspecies in that new location. For natural hybridization to occur between two distinct but re lated populations, the plants from the two populations must flower at the sa me 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 (E llstrand, 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 doe s, and stable new populations result, the process is called introg ression. 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 see d, introgression is much less common than hybridization. For example, in studies done with canola and a weedy relative, backcrossing from the hybrids to the weed s occurred at one-hundred th to one-thousandth the rate of the original hybridization (Stewa rt, 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 nativ e species by incorporating non-native 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 propertie s (USDA-APHIS, 2010a; USDA-ARS, 2008a).

Characteristics that favor natural hybrid ization between two populations include (Mallory-Smith and Zapiol a, 2008; USDA-APHIS, 2010a):

 Presence of feral populations (domestic populations gone wild) and uncontrolled volunteers;

 Presence of a high number of hi ghly compatible relatives;

 Self-incompatibility;

 Large pollen source;

 Large amounts of pollen produced;

 Lightweight pollen;

 Strong winds (wind pollinated);

 Large insect populations (insect pollinated); and44  Long pollen viability.

Additionally, the creatio n of a hybrid depends on a series of events including:

 A pathway for the gene of interest of one plant species to ente r the population of the species to be hybridized (i.e., the parent pl ant and the recep tor plant must be able to produce fertile offspring); and

 The hybridization must confer a fitness adva ntage that allows the gene, over multiple generations, to develop into a su stainable, reproducing population.

The rate and success of gene flow is dependent on numerous external factors in addition to the donor/recipient plant. General extern al factors related to pollen-mediated gene flow include the presence/abundance/distance of sexually-compatible plant species; overlap of flowering phenology between popul ations; the method of pollination; the biology and amount of pollen produced; and w eather conditions, incl uding temperature, wind, and humidity (Zapiola et al., 2008). S eed-mediated gene flow also depends on many factors, including the absence/presence /magnitude of seed dormancy; contribution and participation in various di spersal pathways; and environmen tal 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). Th e 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 f ound in fields, hedgerows, roadsides, and riverbanks in those countries (OECD, 2000).

Although there are no wild rela tives with which soybean can share transgenes, such introduced genes have the potenti al to move within cultivat ed 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 proxim ity (Caviness, 1966; OECD, 2000). Cross-pollination at distances 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 self-pollinated 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 e nvironmental conditions. The pollen usually45 remains viable for two to four hours, and no viable pollen can be detected by late

afternoon. Natural or artificia l cross-pollination canonly 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 plan ts of other soybean varieties occurring at very low frequency (0 to 6.3%) in adjacen t 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 tr ait (fatty acid composition changes) would not likely confer a selective a dvantage to the recipient soybea n. Specific traits of soybean also limit their potential as weeds. Matu re soybean seeds have no innate dormancy, are sensitive to cold, and are not expected to su rvive in freezing winter conditions (Raper Jr. and Kramer, 1987). The only known propagati on 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 pl ants that might grow in previously planted fields or from spilled seed under some favorable environmental conditions can be easily controlled mechanica lly 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 fro m 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 eviden ce 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 bacter ial expression. Thus, even if horizontal gene transfer were to o ccur, proteins corresp onding to the transgenes are not likely to be produced. Fourth, the FDA has evaluated horiz ontal 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 mo st biochemical soil processes (Garbeva et al., 2004). They also suppress soil-borne plant diseases and promote plant growth (Doran et al., 1996). The main factors affecting microbial population size and diversity include soil type (texture, structure, organic matter, aggregate stability, pH, and nutrient content), plant type (providers of speci fic carbon and energy sources into the soil), and agricultural46 management practices (crop ro tation, tillage, herb icide and fertilizer application, and irrigation) (Garbeva et al., 2004). Plant roots, incl uding 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 bu lk soil (Garbeva et al., 2004).

Members of the bacterial families Rhizobi aceae and Bradyrhizobiaceae form a highly complex and specific symbiotic relationship with leguminous plants, including soybean (Gage, 2004). The nitrogen-fixing plant-micr obe symbiosis results in the formation of root nodules, providing an environment in whic h differentiated bacter ia called bacteroids are capable of reducing or fi xing atmospheric nitrogen. Th e product of nitrogen fixation, ammonia, then can be used by the plant. In soybean, atmospheric nitrogen is fixed into ammonia through a symbiotic asso ciation 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 yi eld of soybean (Ferguson et al., 2006).

It is necessary that an adequate soil popul ation 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 suppl ied if a soybean crop has not been recently grown on the field. Although the bacteria persis t for several years in soil, their numbers may not be sufficient to insure adequa te nodulation (Bottomley, 1992). Various commercial sources of inoculants such as multiple strains of Bradyrhizobium can be applied to seeds just before planting, many w ith similar results (Beuerlein, 2005). From one season to the next, the inoculated bact eria in soil may change characteristics or phenotypes and diverge from traits expresse d 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, a nd 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 w eeds within the fields and by other non-crop plants at the margins. These are indicator s of the overall environment, but do not identify the interaction of all plants, ani mals, and microorganisms in an ecosystem, which is the definition of biodiversity (Wilson, 1988). Biodiversity provides valuable genetic resources for crop improvement (Har lan, 1975) and also provides other functions beyond food, fiber, fuel, and income. These include pollination, genetic introgression, biological control, nutrient recycling, compe tition against natural enemies, soil structure, soil and water conservation, dise ase suppression, control of lo cal microclimate, control of local hydrological processes, and detoxifi cation of noxious chemicals (Altieri, 1999). The loss of biodiversity results in a need fo r costly management practices in order to provide these functions to the crop (Altieri, 1999).47 The degree of biodiversity in an agroecosystem depends on four primary characteristics: 1) diversity of vegetation within and ar ound 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, hedge rows, wetlands, etc., has been used to reintroduce biodiversity into large scale monoc ultures. Other enhancement strategies include intercropping (the planting of two or more crops simultaneously to occupy the same field), agroforestry, crop rotations, co ver crops, no-tillage, composting, green manuring (growing a crop specifically for the p urpose of incorporati ng it into the soil in order to provide nutrients and organic ma tter), addition of organic matter (compost, green manure, animal manure, etc.), and hedgerows and windbrea ks (Altieri, 1999).

Agricultural land subject to intensive farmi ng practices, such as that used in crop production, generally has low levels of biodiversity compared with adjacent natural areas. The use of broad-spectrum insecticid es/herbicides is one of the most severe constraints for biological diversity in crop s (USDA-APHIS, 2010a). Tillage, seed bed preparation, planting of a monoculture crop, pe sticide use, fertilizer use, and harvest may all limit the diversity of plants and animals (Lovett et al., 2003).

Tillage practices may impact biodiversity, a nd the type of tillage may be dependent upon adoption of a GE herbicide tolerant crop. For example, while conventional production of a non-GE field crop may typically be acco mplished using intensive tillage, a GE crop

with herbicide tolerance traits may facilitate use of conser vation 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 conserva tion tillage (~63% (CTIC, 2010b)); the conservation tillage rates for non -transgenic soybean would likel y be substantially less if

there were no herbicide tolera nce 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 af ter harvest may in some cases be a source of food for birds and other wildlife in fall, wi nter 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 ma y differ between the three soybean production methods: conventiona l 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 cr ops that are resistant to insects (e.g., Bt crops) or herbicides (e.g., glyphosate-toleran t or glufosinate-tolerant crops.) Different studies have indicated potentia l decreases in biological diversity or abundance due to GE crops, or the presence of a pesticidal protei n in some GE crops (Bt) (e.g., (Hansen Jesse and Obrycki, 2000; Pilcher et al., 2005; Ponsar d et al., 2002). Other studies of GE crops,48 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; Marv ier et al., 2007; Romeis et al., 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 eff ects 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 prop ose 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 so ybean 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 he rbicide tolerant crops with conventionally managed controls—beets, winter oilseed rape and maize (Squire et al., 2003). In two herbicide tolerant crops (beets and winter oi lseed rape), weed bio mass was significantly reduced over those in the conventional varieties (Heard et al., 2003). Decreases were detected in invertebrate populations using th e 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 (whe ther in GE plants or the conventional control) the herbivores, po llinators 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 conventional than herbicide tolerant beet and rape crops (Chamberlain et al., 2007), but herbic ide 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 No rthern Tier states, and relative to corn and soybean, environments with abundant crop t ypes and non-crop plants provided greater

“biocontrol services” than does extensivel y planted soybean (Gardiner et al., 2009). Total insect diversity in GE glyphosate tolera nt soybean has been co mpared 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 pl ots (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 suppre ssion, 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 im pacts may be related to use of one specific49 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 incl ude GE glyphosate tolerant crops. In the case of soil microorganisms, variations in nu mber and species can be observed following many ‘normal’ agronomic inte rventions (Kowalchuk et al., 2003), but ascertaining those that are relevant to types of production systems require detail ed analysis. From 10 years of observations, Kremer and Means (Kre mer 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 summari zed 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 e xperimentally, systematic analysis of indicator groups representing di fferent 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 complicati on with biodiversity st udies is separating expected impacts from indirect impacts. Fo r example, reductions of biological control organisms are seen in some Bt-expressing GE crops, but are cause d by reduction of the pest host population following transgenic pe sticide 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 pr oduction 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 responsibil ity of food manufacture rs 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 unde rgo 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 consultati on with the FDA. In a consultation, a developer who intends to commercialize a bioe ngineered food meets with the agency to identify and discuss relevant safety, nutritional, or other re gulatory issues regarding the bioengineered food and then submits to FDA a summary of its scientific and regulatory50 assessment of the food. FDA evaluates the submission and responds to the developer by

letter.

As noted by the National Research C ouncil (NRC), unexpected and unintended compositional changes arise with all form s of genetic modification, including both conventional hybridizing and genetic engineerin g (NRC, 2004) The NRC also noted that at the time, no adverse health effects attr ibuted to genetic engineering had been documented in the human population. Review s on the nutritional qua lity of GE foods have generally concluded that there are no significant nutriti onal differences in conventional versus GE plants for food or an imal feed (Faust, 2002; Flachowsky et al., 2005).

Monsanto has provided the FDA with information on the identity, function, and characterization of the genes, including expres sion 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 assessmen t 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 Sept ember 2009 (US-FDA, 2009a); SDA is to be used as an ingredient in baked goods a nd 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 break fast cereals and pasta, it enha nces protein content (United Soybean Board, 2009). In baked goods, soups, meats and poultry it may emulsify, absorb fats and water, provide adhesion or cohesi on 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 fo r functional propertie s, 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 prim ary constituent of many foods and numerous other products (USB, 2011c).

Soybean oil achieved prominen ce as a food oil after cott onseed 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 o il 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).51 Table 9. Percentages of linoleic and linol enic 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 --

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 essentia l polyunsaturated fatty acids, an omega-3 (linolenic: C18:3) and an omega-6 (linoleic: C18:2), in appreciable quantities. Another principle fatty acid constituen t 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 aci ds that may support good human health or correct health concerns, but are not represente d in soy oil. In a

review of the litera ture, 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-relate d cognitive decline acco rding 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, linol enic acid, can be metabolized by human biosynthetic processes to the fatty acids EP A 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 ha s been studied, and it is far more efficient than biosynthesis of EPA from alpha linolen ic 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 efficien cy 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 all52 typical vegetable o ils 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 ecologica lly sustainable alternative. This source relies on conversion of SDA by human metabolism into the healthful fatty acids. Sourcing these fatty acids from soybean spar es fish which may be in reduced supply because of overfishing of resources in worl d 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 (Danie lls, 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 unsat urated fatty acids (Starling, 2011). EPA and DHA are also produced by yeast such as Yarrowia lipolytica

, a species which also synthesizes food grad e 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 infreque nt 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 inexpens ive specialty oil. In the U.S., the market for omega-3 fatty acids for functional foods is $4 billion and for supplements is $1.3 billion (Packaged Facts (Mar ket 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-flavor s (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 si milar 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 ve getable 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 tr ans hydrogenation (which destroys linolenic acid). Although these strategies increase oxida tive 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 (U niversity of Connecticut, 2011). Th e essential fatty acid, linolenic acid, should continue to be available in f ood products to enhance content of healthful53 DHA and EPA and the longer chain fatty acids, rather than be redu ced (Dubois et al., 2007); replacement with another omega-3 fatty acid such as stearidonic may be a useful dietary direction. At present, U.S. Na tional Academy of Sciences (NAS) has not discerned any deficits in curre nt U.S. dietary intake. NAS/I nstitute of Medicine advises an Acceptable Macronutrient Distribution Ra nge (AMDR) of omega-3 polyunsaturated fatty acids as 0.6 to 1.2% of dietary energy, an d 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 th ere 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 agri cultural chemicals, and to plant materials. Production of soybean exposes workers to herbicides, and acceptable exposures are regulated by U.S. EPA labels. EPA’s Work er 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 a nd pesticide handlers. The WPS offers protection to more than two and a half m illion 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, notific ation of pesticide applications, use of personal protective equi pment, restricted entry intervals following pesticide application, decontamination supp lies, and emergency medical assistance.

Grower compliance with all U.S. EPA re quirements is required. MON 87769 soybean has no added herbicide tolerance, so its cu ltivation would be similar to that of nonherbicide tolerant soybean. N one of the agricultural chemical s that would be used with MON 87769 soybean differ from those used with other typical commercial soybean varieties. Although an allergen ic 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 thos e produced by many other plants and are generally not allergenic (Hefle and Taylor, 1999), but rather are required human di etary constituents.

2.6 Animal Feed

Animal feed concerns surrounding GE soybean primarily involve the animal consumption of GE soybean products. Soybean m eal 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 deve loped for conventional use and for use in organic production systems, are not routinely required to be eval uated by any regulatory agency in the U.S. for feed safety prior to release in the market. Under the FFDCA, it is54 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 regulato ry 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 appl icants who wish to commercialize a GE variety that will be included in the food s upply have completed a consultation with the FDA. In a consultation, a de veloper who intends to commer cialize a bioengineered food meets with the agency to identify and disc uss relevant safety, nutritional, or other regulatory issues regarding th e bioengineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food. FDA evalua tes the submission and responds to the de veloper by letter.

Monsanto has provided the FDA with information on the identity, function, and characterization of the genes, including e xpression 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 consul tation process with FDA for the commercial distribution of MON 87769 soybean and submitte d a safety and nutritional assessment of food and feed derived from MON 87769 soyb ean to the FDA on March 23, 2009 (BNF No. 00117) (Monsanto, 2010b). FDA is cu rrently evaluating the submission.

2.7 Socioeconomic

2.7.1 Domestic Economic Environment

Soybean first entered North America in the 18 th century (Hoeft et al., 2000). Sometime during the 1930s, soybean was processed indus trially in the U.S. for edible oil and protein meal. 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. e xported $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 incl ude Japan and the EU.

Soybean Production Operating Costs

Managing production costs is a major com ponent 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 th e U.S. in 2006 was $93.41 per acre, with the value of the production less operating cost re ported to be $161.43 pe r acre (USDA-ERS, 2006b).55 Soybean Products

Soy meal typically contains about 50% protein by dry weight , and is the most important product of soybean production. From productio n and feeding statistics, in 2010 about 67% of the domestic-crushed soybean meal wa s fed to domestic animals, and 28% of the meal was exported (most likely for animal feed in the internationa l 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 (s oynuts) or from fresh soybeans (edamame) (Soyconnection, 2011). The domestic food use of soybean oil is mainly in frying oils, salad and cooking oils, and ma rgarines (SoyStats, 2010d). In 2009, these three categories represented approximately 85% of the soybean oi l market in the U.S., with industrial uses consuming the remaining 15% (SoyStats, 2010d ; USSEC, 2006). Soybean oil industrial uses include plastics, lubrican ts, coatings, printing inks and adhesives, emulsifiers, surfactants (industrial de tergents and cleaners as well as so lvents), resins, and biodiesel, among others (AGRA, 2009; USB, 2010b). S oy-based industrial oil products have many advantages in the marketplace, including be ing inherently biodegradable, having low ecotoxicity, and being derived from renewa ble resources (USSEC, 2006). The extraction of oil from soybeans also creates a highly va lued solid, soybean meal, which is used for animal food in all sectors (swine , beef, poultry, dairy and fish).

Prices for soybean oil typical ly are among the lowest among t hose 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 October-September 2006/2007 corn oil pri ces 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 becomi ng the top choice of food processors and industrial processors for feedst ock in these industries.

Changes in fatty acid profile may impact f ood and industrial uses of the soybean oil. Fatty acid composition of the soybean oil affects melting point, oxi dative stability, and chemical functionality, and changes in any of these can impact the market sector of the product (APAG, 2011). Table 10 illustrates seve ral of the key physical properties of the fatty acid constituents of soybean oil.56 Table 10. Properties of select fatty acids.

Fatty Acid Fatty Acid Lipid

Number 1 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 o il, and various foods and industrial products are formulated to take these properties into consideration. Many of the commercial vegetable oi ls are a carefully blended mix to take advantage of the properties of the constituent fatty acids (Cargi ll, 2011 ). A soy oil with a high content of

oleic acid and low content of polyunsaturated fatty acids re sults in an oil with high oxidative stability, a critical property for industrial lubrican ts, as well as achieving the food industry needs for a soy-based oil without trans fatty acids (Cahoon, 2003; Soyconnection, 2011).

Soy Industry Description

Soybean industry comprises two main gr oups, commodity production businesses and the users of soybean products. The commod ity production business begins with the providers and developers of th e 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 s oybean processors or users. The downstream purchasers are animal feed producers, food producers, oil users in food and industrial sectors, and industrial produc t 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 cer tain number of comm itted acres, specifying57 methods of productions and where the seed ma y be sold, and establishing standards for the product when delivered. Contracts between the grower s 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 pl anting and applied chemicals, and the second are the buyers of soybean grain, the elevators. Both are ne eded 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 contra ct with the elevator may specify means of production, crop performance and seed quality.

Soybean meal is the most important product de riving from soybean seed and meal is the product that drives demand for soybean rath er 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 aff ected by many variables, including genetics of the crop, details of the climate including te mperature, 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., 20 02). Consequently, a range of values for soybean oil can be distinguished in soybean va rieties 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 (U SB, 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 i ndustries 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, nuggets, and tofu. Vegetable uses include edamame, and soynut s. Simulated ‘milk products’ include soymilk beverage, soy cheese, yoghurt, and ice cream.

Oil Users. In the production of oils from o ilseed 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 a58 continuous, automated mode. The crushing busin ess, which extracts crude vegetable oil and meal, sends the oil to refiners, or may reta in some for industrial and fuel users. The refiners may be separate physically from th e 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, pr oduce margarines, shorte ning, and bulk fats or oils. In 2007, soybean receipts at oil crushing facili ties attained to 54.4 million tons, with slightly more crushed than originating from receipts (US Census Bureau, 2008). Specialty oils when produced at facilities ma king commodity oils are produced in batches or only semi continuously and supply specializ ed needs of the food processing or other commercial products industries. The total va lue of products from the primary soybean processing industry were estimated at $18 billion (US Census Bureau, 2009a).

The second industry comprises the many va lue-added businesses which may employ starting feedstocks from soyseed or othe r oilseed sources, and which manufacture products from commodity oil or a variety of specialized oi ls. 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 pr operties (such as reac tivity) and physical properties (such as melting points), as well as other functional prope rties which are taken into account when they are incorporated into foods. Oils high in unsaturated fatty acids (5-15%. such as those derived from hydrogena ted soybean oil, stearin fractions of palm oil, etc.) are useful in making solid fat pr oducts such as baking shortenings (O'Brien, 2009a), while oils low in satura ted 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 adve rsely 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 polyuns aturates are the most suscep tible to such oxidation among food oils. Linoleic and particul arly linolenic in traditiona l 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 linol enic acid decreases the possibility that off- flavors will develop. This process also produces “trans” fatty acids, which have been linked to deleterious consequences for human health, and have encouraged the development of other soybean lines with altered fa tty 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 8 22,000 metric tons in 2008/2009 (USB, 2011b).59 Soybean biodiesel in 2007 had a value of $1.09 billion dollars. By comparison, fuel ethanol had a value of $6.6 billion (US Cens us Bureau, 2009a). Soaps, amines, fatty acids and oleo chemicals is the second larg est consumer of industrial soybean oil at 140,000 metric tons (see Table 11) (USB, 2011b). Paints, coa tings and inks rank third, with 118,000 metric tons, and polyols and plas tics 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., Br azil, Argentina, China, and India, which accounted for approximately 91% of the gl obal soybean producti on in 2007 (Soyatech, 2010) (see Table 12). Soybeans produced in Ch ina and India are prim arily for domestic use. A significant portion of soybean produced in the U.S., Brazil, and Argentina is traded globally in the form of soybean ha rvested seed, soybean meal, or soybean oil (Monsanto, 2010b). Globally, the U.S. was th e largest soybean s eed export country; whereas Argentina led the soybean meal and soybean oil expo rt markets in 2007 (Soyatech, 2010).60 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, harveste d soybean acreage per farm increased from 114 acres in 1978 to 229 acres in 2007 (US DA-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). I rrigation 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 identifiedlargely as partnerships and small familyheld 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 fa rms is reported as approximately 623 acres; whereas, the average acreage of a more specia lized soybean farm operator is reported at 390 acres (USDA-ERS, 2006b). Nearly 60% of these specialty soybean farmers reported61 annual income less than $40,000; whereas, 76% of commodity soybean farmers reported incomes exceeding $40,000 per year (USDA-ERS, 2006b).

Industrial soybean crushers, as represente d 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 s oybean. 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 pa rts of the soybean industry are included in summaries for other oil product s; additional details of soybean businesses

from these Census Bureau statistics thus canno t be distinguished. To provide perspective about one soybean processor (South Dakota S oybean Processors), this business is a cooperative with 2,200 farmer/members. This crushing/refining business produces refined and bleached soy oil for industrial buye rs, 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 da ta for the numbers of employees engaged in various industrial production sectors usi ng soybean products. However, the largest category of industrial products, biodiese l, 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 20 09 biodiesel production. Food production involving soybean products has reached $4.5 billion in 2009 (SANA, 2011download) and total employment in this industry is no t readily available.62 3 ALTERNATIVES

This document analyzes the pot ential environmental consequences of a determination of nonregulated status of M ON 87769 soybean. To respond fa vorably to a petition for nonregulated status, APHIS must determine th at 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. Th erefore 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: Conti nuation 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. Perm its issued or notifications acknowledged by APHIS would still be requi red for introductions of MON 87769 soybean and measures to ensure physical and reproductive confin ement would continue to be implemented. APHIS might choose this altern ative if there were insuffici ent evidence to demonstrate the lack of plant pest risk from the unc onfined cultivation of MON 87769 soybean.

This alternative is not the Preferred Altern ative 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 ri sk status and responding to the petition for nonregulated

status.

3.2 Preferred Alternative: Determinat ion 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 articl es 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 th e agency’s authority under the plant pest provisions of the Plant Protection Act. B ecause the agency has concluded that MON 87769 soybean is unlikely to pose a plant pest ri sk, a determination of nonregulated status of MON 87769 soybean is a respons e that is consistent with the plant pest provisions of the PPA, the regulations codified in 7 CF R part 340, and the biotechnology regulatory policies in the Coordinated Framework.63 Under this alternative, gr owers may have future access to MON 87769 soybean and progeny derived from this event if the de veloper decides to commercialize MON 87769 soybean.

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 th e Plant Protection Act, and th e regulations at 7 CFR part 340, with respect to environmental safety, efficacy, and practicality to identify which

alternatives would be further consider ed for MON 87769 soybean. Based on this evaluation, APHIS rejected severa l alternatives. Th ese alternatives are discussed briefly below along with the specific reasons for rejecting each.

3.3.1 Prohibit Any MON 87769 Soybean from Being Released

In response to public comments that stated a preference that no GE organisms enter the marketplace, APHIS considered prohib iting the release of MON 87769 soybean, including denying any permits associated with the field testing. APHIS determined that this alternative is not appropriate give n that APHIS has concluded that MON 87769 soybean is unlikely to pose a plan t pest risk (USDA-APHIS, 2010c).

In enacting the Plant Protecti on Act, Congress found that

[D]ecisions affecting impor ts, 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 Tec hnologies Interagency Policy Coordination Committee developed broad prin ciples, consistent with Ex ecutive Order 13563, to guide the development and implementation of polic ies 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 othe rs, to the extent permitted by law, when regulating emerging technologies:

“[D]ecisions should be based on the be st reasonably obtainable scientific, technical, economic, and other inform ation, within the boundaries of the authorities and mandates of each agency”

Based on the PPRA (USDA-APHIS 2011) and th e scientific data evaluated therein, APHIS concluded that MON 87769 soybean is unlikely to pose a plant pest risk. Accordingly, there is no basis in scien ce for prohibiting th e release of MON 87769 soybean.64 3.3.2 Approve the Petition in Part

The regulations at 7 CFR 340.6(d)(3)(i) state that APHIS may "appr ove the petition in whole or in part." For example, a determin ation of nonregulated st atus in part may be appropriate if there is a plant pest risk associ ated 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 c onsidering approval of the petition only in

part.

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 M ON 87769 soybean from conventional or specialty 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 is olation distances woul d 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 re stricting the producti on of MON 87769 soybean based on the location of production of non-GE soybean in organic production systems or production systems for GE-sensitive markets in response to public concerns regarding possible gene movement between GE and non-GE plants. However, as presented in APHIS’ PPRA for MON 87769 soybean, there ar e no geographic differences associated with any identifiable plant pest risks fo r MON 87769 soybean (USDA-APHIS, 2010c). This alternative was rejected and not analy zed in detail becaus e 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 geographi cally restricted area. Therefor e, such an alternative would not be consistent with APHIS’ statutory au thority under the plant pe st provisions of the Plant Protection Act and regulations in Pa rt 340 and the biotechnol ogy regulatory policies

embodied in the Coordinated Framework.

Based on the foregoing, the imposition of isola tion distances or geographic restrictions would not meet APHIS’ purpose and need to respond appropriately to a petition for nonregulated status based on the requiremen ts 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 ge ographically isolate th eir non-GE soybean production systems from MON 87769 soybean or to use isolation distances and other management practices to minimize gene move ment between soybean fields. Information to assist growers in making informed mana gement decisions for MON 87769 soybean is

available from Association of Official Seed Certifying Agencies (AOSCA, 2010).65 3.3.4 Requirement of Testing for MON 87769 Soybean

During the comment periods for other pe titions for nonregulated status, some commenters requested USDA to require and pr ovide 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 plan t pest risk (USDA-APHIS, 2010c), the imposition of any type of testing requiremen ts is inconsistent with the plant pest provisions of the Plant Protection Act, the regulations at 7 CFR part 340 and biotechnology regulatory policie s 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.

3.4 Comparison of Alternatives

Table 13 presents a summary of the potential im pacts associated with selection of either

of the alternatives evaluated in this EA. Th e impact assessment is presented in Section 4

of this EA.

Table 13. Summary of issues of potential im pacts 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 Practi ces Unchanged Unchanged

Physical Environment

Water Resources Unchanged Unchanged

Soil and Land Use Unchanged Unchanged

Air Quality Unchanged Unchanged

Climate Change Unchanged Unchanged66 Biological Resources

Gene Movement and

Weediness Unchanged Unchanged

Animals Unchanged Unchanged

Plants Unchanged Unchanged

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 compliant67 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 A lternative and the Preferred Alternative for MON 87769 soybean are described in detail throughout this se ction. A cumulative effects analysis is presented for each potential ly affected environmental concern. Certain aspects of this product and its cultivation would be no differe nt between the alternatives:

those instances are described below.

4.1 Scope of Analysis

Potential environmental impacts from the No Action Alternative and the Preferred Alternative for MON 87769 soybean are describe d in detail throughout this section. An impact would be any change, positive or negati ve, from the existing (b aseline) conditions of the affected environment (described for each resource area in Section 2.0). Impacts may be categorized as direct, i ndirect, or cumulative. A direct impact is an effect that results solely from a proposed action without in termediate steps or processes. Examples include soil disturbance, air em issions, 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 qu ality changes resulting from soil erosion due to increased tillage, and worker safety imp acts resulting from an increase in herbicide

use.

A cumulative effects analysis is also in cluded 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 ar e no longer subject to the regu latory requirements of 7 CFR part 340 or the plant pest provisi ons of the Plant Prot ection Act. If there are no direct or indirect impacts identified fo r 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 qual itative assessment of potential impacts. Certain as pects of this product and its cultivation may be no different between the alternatives; t hose are described below.

Although the preferred a lternative 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, 2010d) , cultivation of MON 87769 soybean will be limited to the

Northern Tier states of North and South Dakota, Minnesota, Wisc onsin, and Michigan.68 4.2 Agricultural Production of Soybean

One of APHIS’s missions is to improve American agricultura l productivity. Best management practices are commonly accepte d, practical ways to grow soybean, regardless of whether the soybean farmer is using conventional prac tices with non-GE or GE varieties, or using organic practice. These management practices consider cropspecific planting dates, seeding rates, and ha rvest times, among others. Over the years, soybean production has resulted in well-es tablished, widely-practiced management practices that are available through local Cooperative Extens ion Service offices and their respective websites. The National Informati on System for the Regional Integrated Pest Management Centers (IPM Centers) publishes crop profiles for major crops on a state-bystate basis. These crop profiles provide pr oduction guidance for local growers, including recommended practices for specific pest contro l. 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 agronom ic or phenotypic differences between MON 87769 soybean and control va rieties of soybean (Monsanto, 2010b). Based on the data provided by Monsanto for MON 87769 soybean (Monsanto 2010), as well as previous experience w ith other GE soybean varieties that have been widely adopted by growers since th eir introduction in 1996 (USDA-ERS, 2010b), APHIS has concluded that none of the best manageme nt practices for agri cultural 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 pe st provisions of the Plant

Protection Act. Consistent with the lack of changes to agronomic properties, the potential impacts on agricultura l 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 conti nually under development. In 2009 and 2010, over 75 million acres in the U.S. were plante d in soybean, with over 93% of the soybean expressing herbicide tolera nce (USDA-ERS, 2010a, 2010b).

No Action Alternative: Acreag e and Area of Soybean Production

Based on current acreage trends, commodity s oybean 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 va rieties 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 A lternative, this range of production is not expected to change.69 Preferred Alternative: Acreag e and Area of Soybean Production

Monsanto has determined that the SDA c ontent of MON 87769 soybean seed would be greatest when grown in the most northerly ar eas 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 te mperature may be most relevant during the final stages of seed maturation (Wilcox a nd Cavins, 1992). By limiting the proposed production area, Monsanto will keep the yield of SDA at the maximal attainable levels (Monsanto, 2010d).

Production in the Northern Tier states will be encouraged by producing seed only for the lower maturity groups (Monsanto, 2010d). 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 producer s 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 thro ugh 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 dire ct 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 processo rs in major soybean production areas including Alabama, Iowa, Illinois, Indian a, Maryland, Minnesota, Michigan, Missouri, Nebraska, New York, Ohio, Pennsylvania, and South Dakota (Monsanto, 2010b). This area is partially coex tensive 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 fo r 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 fr om marketing their s oybeans at too great a distance from the specialty soybe an 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 th e state, at least 50% of soyb eans were delivered within 10 miles (Purdue Extension. 2006). Thus, even if growers purchased the seed for the soybean variety outside of the expected optim al 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.70 Monsanto plans to market MON 87769 soybean as a specialty variety for producing the novel constituent SDA by this product (Monsan to, 2010b). Monsanto’s field trials have not demonstrated any agronomic or phenotypic differences between MON 87769 soybean and control varieties of soybean (M onsanto, 2010b). The changes in fatty acid composition expressed in MON 87769 soybean do not require changes in cultivation practices when 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 ac ids. MON 87769 soybean is not expected to significantly replace plantings of conventi onal or existing GE varieties where those growers seek to cultivate a commodity soybean variety (Monsanto, 2010b). U nder the Preferred Alternative, a determinati on of nonregulated status of MON 87769 soybean is not expected to increase soybean production, or resu lt in an increase in overall GE soybean acreage or cultivation in new regions. Imp acts 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 burndow n, 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 situ ations, rather than principl e use of a single herbicide (glyphosate, glufosinate or ALS) applied preplant or over the top, depending on the herbicide tolerant variety planted.

No Acton Alternative: Agronomic Practices

Under the No Action Alternative, soybean crop rotation practi ces and herbicide pesticide use will likely rema in as it is practiced toda y by the farming community. Growers will

continue to have access to exis ting herbicide-tolerant soybean products that are no longer subject to the regulatory requi rements 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 a nd existing non-regulated GE s oybean 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.71 Preferred Alternative: Agronomic Practices

Monsanto has determined that the SDA c ontent of MON 87769 soybean seed would be greatest when grown in the most northerly areas of soybean production in the U.S. (Monsanto, 2010d). Both genotype and environm ent can simultaneously influence ratios of multiple fatty acids in soybean (Hou et al., 2006). The effects of temperature may be most relevant during the fina l stages of seed maturation (Wilcox and Cavins, 1992). By limiting the proposed production area, Monsanto w ill attempt to keep the yield of SDA at

the maximal attainable levels.

Monsanto will produce seed only for the lower maturity groups (Monsanto, 2010d) 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 elev ator or processor and which will approve the soybean product quality before purchase. Elevat ors and crushers will be restricted to the five states planned for production of this va riety. Many of the grow ers electing to plant MON 87769 soybean and also elevators and cr ushers chosen will likely already have extensive experience in strictly observing standard operating procedures (SOPs) to maintain segregation during storage and cr ush. 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 th e special fatty acids offered by MON 87769 soybean.

Monsanto’s studies demonstrate MON 87769 s oybean is essentially indistinguishable from other soybean varieties in terms of agronomic characteristics and cultivation practices (Monsanto, 2010b; USDA-APHIS, 201 0c). 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 chan ges in fatty acid profile do not impact the ability of soybean to overw inter or become a volunteer.

A determination of nonregulated status of MON 87769 soybean is not expected to alter

the use of herbicides curren tly being used for non-GE soybean production. A preplant burndown herbicide would be used, followed by a pre-emergence residua l herbicide, with timely post plant herbicide a pplications (Sprague, 2006). The use of glyphosate as a post-emergent weed herbicide in other soybean varieties would continue to be the pattern for the majority of soybean production. The til lage 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 in sects or pathogens woul d also be unchanged.

If MON 87769 soybean is not stacked with herb icide tolerant traits, control of herbicide tolerant corn or soybean vol unteers from the previous seas on would not be different from

control of such volunteers ar ising after planting herbicide tolerant crops with typical rotational crops. Numerous other register ed soybean herbicides are available to eliminate these volunteers (See Table IX-4 in Petition (Monsanto, 2010b)).72 Monsanto’s field trial and laboratory anal yses demonstrated that the agronomic performance of MON 87769 soybean was func tionally identical to its non-transgenic counterpart (Monsanto, 2010b). No increases in fertilizers an d pesticides were required, nor were any changes in cu ltivation, planting, harvesting, and volunteer co ntrol required (Monsanto, 2010b). It is expect ed that similar agronomic pr actices that are currently used for other commercially available GE soybean will also be used by growers of MON 87769 soybean. Overall impacts would be si milar to the No Action Alternative.

4.2.3 Soybean Seed Production

Soybean seed production is managed by seed producers using AOSCA standard methods to preclude gene flow between varietie s (Bradford, 2006; Sundstrom et al., 2002). Soybean is considered a self -pollinated species, exhibiting a high-percentage of selffertilization (OECD, 2000). Co mmon practices to preserve va rietal identity include: 1) maintaining isolation distances to prevent pollen movement from other soybean sources; 2) planting border or barrier rows to in tercept pollen, employing natural barriers to pollen; and 3) field monitori ng for off-types, 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 agronom ic or phenotypic differences between MON 87769 soybean and control vari eties of soybean (M onsanto, 2010b), other than differences of fatty acid content. Ba sed 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 conclude d that the availability of MON 87769 soybean would not alter the agronomic pr actices, 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 conventi onal and GE seed, and the produc tion practices used to grow soybean seeds would be similar to the No Ac tion Alternative. Ac cordingly, there are no

differences between the No Action and Prefe rred Alternatives with regard to seed production.

4.2.4 Organic Soybean Production

Organic production plans prepared pursuant to the National Or ganic Program (NOP) include practical methods to protect or ganically-produced crops from accidental contamination with genetically engineered materials. Typicall y, organic growers use more than one method to maintain organic certification and prevent unwanted material from entering their fields including: isol ation of the farm, physical barriers or buffer73 zones between organic production and non- organic production, as well as formal communications between neighboring farms (B aier, 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 producer s of non-GE soybean, particul arly 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 us es for the analyses of the alternatives.

Historically, organic soybean production represe nts 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 herbicide-tolerant (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 or ganic production, are expected to remain the

same under the No Action Alternative. Si nce 2001, GE varieties of soybean have dominated the market, representing 68% of th e market in 2001, and 93% of the market in 2010 (USDA-ERS, 2010b). Although organic s oybeans 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 soyb ean fluctuated between 72 million and 64 million acres, although organic soybeans rang ed 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 ch ange under the No Action Alternative (USDAERS, 2010b; USDA-NASS, 2007a, 2010e).

Preferred Alternative: Organic Soybean Production

It is not likely that organic farmers, or ot her 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 cu rrently cultivated on 93% of the U.S. soybean acreage (USDA-ERS, 2010b), and organic varieties comp rise 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 analys is). MON 87769 soybean should not present any new or different issues and impacts for organic and other specialty soybean producers and consumers.74 According to the petition, agronomic tria ls conducted in 2006 and 2007 at 21 field

locations in the U.S. demonstrated that M ON 87769 soybean in combined site analysis is not significantly different for plant growt h, yield, and reproductiv e 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 di fference in agronomic properties, MON 87769 soybean is not expected to have an increased ability to cross pollinate organic soybean

varieties.

The practices currently employe d to preserve and maintain purity of organic production systems would not be require d to change to accommodate the production of MON 87769 soybean. C ommon production practices for soyb ean and the practical methods typically used by soybean farmers under organic conditions (NCAT, 20 03) 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 Mons anto as a specialty variety to take advantage of the high content of SDA (Monsanto, 2010b). Consistent with no required differences in agronomic practices , and the intention of Monsanto to produce soybean for a specialty market, MO N 87769 soybean is not expected to displace current organic soybean production.

The acreage devoted to organic soybean is e xpected to remain small regardless of

whether new varieties of GE or non-G E soybean varieties, including MON 87769 soybean, become available for commercial soyb ean production. As noted above for the time period of 2005 to 2008, when the to tal U.S. acreage dedicated to soybean

fluctuated between 72 million and 64 mil lion acres, the acreage devoted to organic soybeans was relatively stable, report ed between 122,000 and 126,000 acres (USDAERS, 2010f). The percentage of the soybean acreage th at 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 indus trial 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.75 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 no nregulated status, MON 87769 soybean would become an additional specialty soybean variet y that would be produced and marketed as an IP oil. Monsanto plans to exercise pr oduct stewardship in a “closed loop” system (Monsanto, 2010b) and would supervise the sa le 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 give n full information about maintaining product segregation, about necessary procedures and equipment, and Monsanto would make themselves available for consulting with entiti es 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. Because th e closed loop system is a robust one, APHIS has concluded that the m echanism Monsanto has proposed would be capable of implementing effective isolati on from other specialty oils, as well as commodity oils. APHIS concludes that ot her soybean specialty crops would not be affected by the new SDA producing line MON 87769 soybean.

4.3 Physical Environment

4.3.1 Water Resources

The climate in the Heartland south and east of the Great Lakes, a nd Eastern portions of the Great Plains of the U.S. provide sufficien t water under normal climatic conditions to produce a soybean crop. The adop tion of herbicide-tolerant so ybean varieties has been a factor in the adoption of conservation pr actices, including conser vation tillage.

Water quality is also preserved in modern s oybean production systems. The increase in conservation tillage practices ha s resulted in a reduction of runoff from agricultural lands, decreasing non-point source pollution of fertilizer and pesticides. Intensive local monitoring of surface water a nd 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 ac reage 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 resulted76 in the adoption of increased conserva tion practices (Monsanto, 2010b). These conservation practices, includi ng reduced tillage and preci sion agriculture, play a significant role in water conservation and ma intaining 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 gr own 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 herbicid e tolerant crops (see Sec tion 2.2.2, Weed Control), may decrease the likelihood of run-off 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 Impact s: Agronomic Practices).

MON 87769 soybean does not change cultiv ation practices for s oybean 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 vari eties already in use, offering no additional agronomic benefits to growers.

4.3.2 Soil Quality

No Action Alternative: Soil Quality

Agronomic practices associated with tradition al and existing non-regulated GE soybean production would not be expected to change under the No Action Alternative. As a result, 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 anal yses demonstrated that the agronomic performance of MON 87769 soybean was func tionally identical to its non-transgenic counterpart (Monsanto, 2010b). No increases in fertilizers an d pesticides were required, nor were any changes in cu ltivation, planting, harvesting, and volunteer co ntrol required (Monsanto, 2010b). It is expect ed that similar agronomic pr actices 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.77 4.3.3 Air Quality

Traditional agricultural practices have the potential to cause nega tive impacts to air quality. Agricultural emission sources includ e smoke from agricultural burning, tillage, traffic and harvest emissions, pesticide drif t from spraying, and nitrous oxide emissions from the use of nitrogen fertilizer (US DA-NRCS, 2006a). Other GHG emission sources associated with agricultura l production include equipmen t emissions (contributing carbon monoxide, nitrogen oxides, and reactive organic gases), particulate matter, sulfur oxides,

and direct emissions of N 2 O from fertilizer application (US-EPA, 2010a).

Conservation practices, incl uding conservation tillage asso ciated 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 ge neration 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 er osion of soils and pest icide drift in winderoded soils (Baker et al., 2005; USDA-NRCS, 2006a). Reduced tillage also increases sequestration rates of potential carbon em issions from soils (Causarano et al., 2006).

No Action: Air Quality

Under the No Action Alternative, c urrent impacts to air quality associated with land acreage and cultivation practices associated with soybean pro duction would not be affected. Agronomic practices associated with conventional soybean production and current GE soybean varieties and which cont ribute to air quality and GHG emissions, including tillage, cultivation, irrigation, pesticide applicat ion, fertilizer applications and use of agriculture equipment, w ould 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 agricu ltural land acreage asso ciated with growing soybean, and is expected to have the sa me effect on air quality as the No Action

Alternative.

4.3.4 Climate Change

No Action Alternative: Climate Chang

Under the No Action Alternative, c urrent impacts on climate change associated with soybean production would not be affected. Agronomic practices associated with soybean production such as tillage, cultivation, irrigation, pesticide a pplication, fertilizer applications and use of agriculture eq uipment would continue on soybeans grown throughout the region.78 Preferred Alternative: Climate Change

There is unlikely to be a measurable change in an agricultural practice that might affect climate change in soybean fields wh ere MON 87769 soybean would be grown. Agronomic practices associated with soyb ean production such as tillage, cultivation, irrigation, pesticide application, fertilizer applications and use of agriculture equipment would continue on soybeans grown throughout th e 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 soyb ean 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 pr ey upon other insects living on soybean plants as we ll as in the vegetation surr ounding soybean fields. The cumulative effects analysis for the potent ial 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, conve ntional and GE soybean production would continue while MON 87769 soybean remains a regul ated article. Potential impacts of GE and non-GE soybean production practices on non-target animals w ould 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 cultiv ation practices for soybean production.

MON 87769 soybean provides a modified fatty acid profile based on the introduction of Primula juliae Δ 6 desaturase (Pj.D6D) and Neurospora crassa Δ 15 desaturase (Nc.Fad3). Changes in fatty acid compos ition resulting from the expression of these genes are not expected to cause 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 co ntains 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.,79 high oleic canola, high oleic safflower, high ol eic sunflower), traditional oils such as olive oil that has a long-histor y 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 severa l plant sources of vegetabl e oil, including conventional soybean and MON 87769 soybean.

Table 14. Comparison of fatty acid prof iles for oil derive d from MON 87769 soybean with several other plant sources

Vegetable Oil Type %

Saturated

Fat 1 % Oleic

Acid 1

(18:1) 2 % Linoleic

Acid 1

(18:2) %

Linolenic

Acid 1,4

(18:3) %

Stearidonic

Acid 3

(18:4) % PUFAs 1

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 Soybean 5 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, 2010c).

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 fatt y acid, one of the more common nomenclature systems. The fi rst number, e.g., 18, i ndicates the number of car bon 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, 2010d).

4. Alpha linolenic totals; add 7% additiona l for gamma linolenic in MON 87769 soybean

5. A3525, the variety originally transformed, a conventional variety.

Monsanto statistically analy zed 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 observati ons for constituents were significantly different, but except for linoleic acid, were ei ther within the published variability of existing commercial cultivars, or were actu ally 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 desatu rases introduced into the soybean to make SDA. In seed, statistically significant differe nces were found in 19 nutrien ts other than fatty acids including amino acids in combined site analys es, and these were all of less than 10%, but

were not outside the 99% tole rance level for commercial soyb ean properties. Differences in fatty acids (including li noleic acid) in combined-sit e analyses between MON 87769 soybean and a conventional control included six fatty acids of the eight analyzed. 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).80 Animals are known to forage on soybean folia ge and seed. With the exception of the introduction of the desaturase genes, ge nes to change fatty acid composition, no phenotypic or morphological differences ha ve been identified between MON 87769 soybean and conventional soybeans. Co mposition of MON 87769 soybean forage was compared to a conventional control (the host va riety used in the transformed variety) and analyzed for fiber and no combined site di fferences 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 commercia l 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 gastri c and digestive fluids (Monsanto, 2010b).

The potential risks to animals from th e consumption of MON 87769 soybean with modified fatty acid composition will be evaluated by the FDA (Monsanto, 2010b). Soybean meal is the most common supplemen tal protein source in U.S. livestock and poultry rations due to its nutrient compositi on, availability, and price. Although MON 87769 soybean is intended to be cultivated as a specialty soybean to ta ke advantage of the SDA production, the soybean meal remaining af ter the extraction of the soybean oil may become a constituent of livestock or poultry food supplements. Monsanto is completing a consultation with FDA on the possible im pacts 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 im pacts to animal diets from the reduced

intake of linoleic acid. Athough the soybean meal de rived 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.

Based on the above information, APHIS conclu des that a determination of nonregulated status of MON 87769 soybean is not expected to have adverse effects on non-target

animals.

4.4.2 Plant Communities

The landscape surrounding a soybean fiel d 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 comm unities may be natural or managed plant

habitats for the control of soil and wind erosion and/or se rve 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).81 No Action Alternative: Plant Communities

Plant species that typically inhabit soybean production systems will continue to be managed through the use of mechanical, cult ural, and chemical control methods, including the use of glyphos ate in those varieties al ready marketed as glyphosatetolerant. No changes to cultivation pr actices are expected in the No Action

Alternative.

Preferred Alternative: Plant Communities

In the event of a determina tion of nonregulated status of MON 87769 soybean, the risks to wild plants and agricultural productivit y from weedy soybean populations are low; volunteer soybean populations are easily ma naged 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 differ ences 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 pr oduction of SDA. Volunteer soybean is normally not a concern. Soybean is not winter hardy, and existing mechanical

and chemical methods are available to ma nage the occasional volunteer soybean in cultivation areas (Carpenter et al., 2002; OE CD, 2000). Several post- emergent herbicides are also widely used to control the pres ence of volunteer soyb eans in subsequent rotational crops (See Table IX -4 (Monsanto, 2010b; Zollinge r, 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 re sult 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 ev aluated: Vertical gene flow and horizontal gene flow. Vertical gene flow, or hybridization and asso ciated introgression, is the movement of genes to sexually compatible relatives (E llstrand, 2003; Quist, 2010). The soybean is considered self-pollinating, and has no wild relatives in the U.S. (Monsanto, 2010b; OECD, 2000). Although some cross-pollina tion 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 re latives 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 two primary issues: 1) the potential for gene flow and introgression to soybean relatives; and 2) the potential impact of introgression. Vertic al 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 mo vement from transgenic crops to sexually incompatible species (Stewart, 2008). Hori zontal gene transfer and consequent82 expression of DNA from one plan t to another sexually incomp atible plant or other phyla (e.g., species of bacteria) is unlikely to occur (Keese, 2008). This event would require physical relocation of the func tional genetic sequences from the transgenic plant to the new location, including not onl y the genes which code fo r the production of specific proteins, but also those portions of the genom e which regulate the ac tivity 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 thateukaryotic cells are naturally capable of stably incorporating genes from the envir onment 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 fe wer than 20 encoded proteins (Keese, 2008). These viruses are, theref ore, constrained as to the t ype and size of novel genetic material which can be acquired by horizont al gene transfer (Stewart, 2008). The development of herbicide resist ance, particularly that found in crop fields treated with glyphosate, is thus not a result of gene transf er but is the result of selective pressures

associated with herbicide use. This issu e 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 probabili ty 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 (S tewart, 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; W ood et al., 2001). Despite what would appear to be millennia of symbiotic relationships between th ese bacteria and their host plants, there is no evidence that these organisms contain ge nes derived from pl ants (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 expressi on, not bacterial expr ession (USDA-APHIS, 2010d). Horizontal gene flow, resulting in th e relocation of entire transgenes including the regulatory portions of the DNA (thos e parts of the DNA which code for the production of the specific proteins in that relocated transgen e) 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; USDA-APH IS, 2010c). Based on this information,

APHIS considers the horizontal gene flow from MON 87769 s oybean or other cultivated GE soybean varieties to unrelat ed species to be unlikely.83 No Action Alternative: Gene Flow and Weediness

Under the No Action Alternative, conventi onal 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 in trogression to occur from MON 87769 soybean to sexually compatible varieties and consider ed the possibility that such introgression

would result in increased weediness. Mons anto’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 iden tified 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 co mposition 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 aci ds, particularly hexade catrienoic and linolenic acids, results in an increase in cold tole rance. 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 (Monsant o, 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 to lerance (USDA-APHIS, 2010c).

In its PPRA, APHIS assessed the weedine ss 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 contro lling 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 anti cipated to give rise to an enhanced weediness or gene flow.

In its petition, Monsanto presented information on phenotypic and agronomic

characteristics collected from field studi es (Monsanto, 2010b). These data included information on seed dormancy, germination, em ergence, seedling vigor, plant height, lodging, days to maturity, shattering, seed wei ght, yields, disease incidence, and insect damage, among others (Monsanto, 2010b).84 APHIS has assessed those parameters includi ng some of those noted above to evaluate the weediness potential of MON 87769 s oybean. Monsanto found no biologically significant differences between MON 87769 soyb ean and the original commercial variety that was transformed for seed dormancy, germ ination, early stand count, seedling vigor, days to 50% flowering, lodging, pod shattering, a nd final stand count. All values were

within the recommended standards for certified soybean s eed (AOSCA, 2009).

To determine whether the vari ety could be more likely to increase gene flow, Monsanto studied pollen viability and morphology. No st atistically significant differences were detected between MON 87769 soybean, the original modified line, and other controls for percent viable pollen or polle n grain diameter (Monsanto, 2010b). No differences in pollen morphology were observed. Thus, differen ces 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, 201 0c). These data indicate that the engineered plant is not differe nt in any fitness characteristics from its parent that are likely to cause the MON 87769 soybean to b ecome weedy or invasive (USDA-APHIS, 2010c).

Based on the above information, APHIS ha s 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 effe ct on gene movement as the No Action Alternative.

4.4.4 Microorganisms

Microorganisms in soil are important com ponents that sustain a nd provide the dynamic aspects of soil associated with critical ecological pro cesses. Nutrient cycling, establishing soil structure c ontributing to plant growth, metabolism of deleterious components are all dependent on the microbial constituents. The h ealth and growth of these microbes may be influenced by many processes and conditions.

No Action Alternative: Microorganisms

There would be no changes to current cu ltivation practices under the No Action

Alternative. Microbes in the field would c ontinue 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 to tal of 21 locations (Monsanto, 2010b). The85 disease analysis included observations of a wi de range of bacterial and fungal pathogens, nematodes, and plant viruses (Table I- 4, I-5 (Monsanto, 2010b)). No significant incidence of disease damage was not ed 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 fatty acid content by MON 87769 soybean does not change soybean interactions with microorganisms in the

field.

Monsanto also evaluated the potential im pacts of these changes on the symbiotic relationship of soybean with the nitrogen-fixing root nodule bacteria Bradyrhizobium japonicum (Monsanto, 2010b). In these studie s, MON 87769 soybean was compared with the original transformed conventional line, and six conve ntional soybean varieties as well as the negative isoline for MON 87769 s oybean (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 indicat e that the expression of the modified fatty acid composition doe s not impact the biology of root nodules formation by the symbiotic bacteria.

Consistent with these te st 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, incl uding 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 incl ude intercropping (the planting of two or more crops simultaneously to occupy the same field), agroforestry, crop rotations, cover crops, no-tillage, composting, green manuri ng (growing a crop specifically for the purpose of incorporating it into the soil in or der to provide nutrients and organic matter), addition of organic matter (compost, green ma nure, animal manure, etc.), adoption of integrated pest management techniques, and the use of hedgerows and windbreaks (Altieri, 1999; Palmer et al., 2010). The a doption 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 micr oorganisms, beneficial organisms, and plants (Dively and Rose, 2003; Naranjo, 2009; Palm er et al., 2010; Sanvido et al., 2006).

No Action Alternative: Biodiversity

Under the No Action Alternative, MON 87769 s oybean would continue to be a regulated article. Growers and other parties who ar e involved in produc tion, handling, processing, or consumption of soybean would continue to have access to GE s oybean varieties that86 are no longer subject to the regulatory require ments of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act, he rbicide-tolerant soybean varieties, and conventional soybean varieties. The implications of a gronomic practices associated with soybean production whether traditional or GE varieties with the attendant effects on biodiversity would not change.

Preferred Alterna tive: Biodiversity

Although soybean fields are cultivated as m onocultures to optimize soybean yield, the landscape adjacent a soybean field may harbor a wide variety of plan ts. Broad spectrum herbicide 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 ot her non-herbicide tole rant varieties, and acreage is not expected to exceed 100,000 acr es in five years (Monsanto, 2010b). Consequently, production MON 87769 soybean is not expected to resu lt in an increase in the application of herbicides or frequenc y 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, a nd algae, would have no effect on animals that might feed on soybean, because the novel oi ls 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 th e 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 quantitie s in foods, and are r eadily digestible in simulated gastric and digestive fluids (Mons anto, 2010b). Thus, no potential for allergic response has been demonstrated by consumi ng the meal deriving from the soybean. Therefore, a determination of nonregulated status of MON 87 769 soybean is highly unlikely to have any direct toxic effects on non-target organisms and is likely to be

neutral or beneficial to anim al and plant biodiversity.

The abundance of diverse beneficial insects wa s assessed over two y ears in four states (Tables I-8 and I-10 (Monsanto, 2010b)). No consistent differences were noted in the populations of these insects ove r 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 sinc e there is no difference in insect damage or populations of pest insects in MON 87769 s oybean and conventional control soybean (Monsanto, 2010b). Populations of pest insects were assessed in four states comparing MON 87769 soybean and conventional line A 3235, the parental line during two growing seasons (Monsanto, 2010). Aphids, beanleaf beetles, leaf hoppers and three moth pests87 among others were assessed over three coll ection periods during th e 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

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 e xposure to this produc t would be limited to

those individuals involved in the cultivation of MON 87769 soybean under regulated

conditions.

Worker Safety

During agricultural production of soybean, agri cultural workers and pesticide applicators may be exposed to a variety of EPA registered pesticides (see, e.g., http://www.cdc.gov/nios h/topics/pesticides/ ). Such chemicals would be expected to include those products currently used for ins ect pest and plant pest management in both GE and non-GE soybean cultivation. Worker sa fety is taken into consideration when a U.S. EPA pesticide label is developed duri ng the registration process. When use is consistent with the label, pe sticides 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 assessmen t in making its determination of the potential impacts of a determination of nonre gulated 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, indicatin g the agency has no further questions

about the characteristic s of the oil, and safety of it s use in foods (US-FDA, 2009a).88 Monsanto’s intention in deve loping MON 87769 soybean is to provide a plant source of omega-3 fatty acid that can efficiently be c onverted to the long chain polyunsaturated fatty acids, DHA and EPA, which are important in prevention or improvement of human

health conditions. Oil derive d 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 imp acts 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 assessed, as were the new fatty acids. Neither desaturase prot ein formed by the introduced sequences have amino acid segments that are structural or i mmunologically relevant to human allergens, and both are easily degraded by simulated ga stric and intestinal fluids (Monsanto, 2010b). The two proteins were purified from immature soybean seed, and tested for adverse effects on mice (Monsanto, 2010b). A ‘N o 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.

Monsanto presents data comparing the fa tty acid and other nutritional element

concentrations with the re ported ranges for conventiona l soybean against commercial tolerance ranges (see summary Table 15, below). MON 87769 soybean fatty acids are compared with conventional soybean and comm ercial ranges of these fatty acids. In addition to evaluating the targeted fatty ac id 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 fa t (as measured by palmitic and stearic acid percentages) in MON 87769 soybean was simila r to that of conventional soybean and89 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 s oybean, 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 li nolenic acid of 7%. Overal l, the total po lyunsaturated fatty acids of MON 87769 soybean and c onventional soybean are similar.

SDA commonly occurs within the environmen t, 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 leas t 13 species (Table X-1 (Monsanto, 2010b)). Many plant species are cultivated as a sour ce 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 healthfu l effects 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 (M onsanto, 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 soybea n. 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 an imal 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 canol a oil. Statistically significant but small differences were observed in the comparisons of the A3525 conventional variety to MON 87769 soybean in the concentrations of severa l fatty acids (16:0 palmitic, 18:0 stearic, 18:1 oleic, 18:3 alpha linolen ic acid, 20:0 arachidic, 22:0 behenic). APHIS evaluated these differences in composition and has de termined that those reported for MON 87769 soybean either fall within the typical commerc ial range for percentage composition or the

99% tolerance interval for commercial s oybean composition (Monsanto, 2010b). Several amino acid percentages, % dry weight of pr oximates (protein and carbohydrate), and two isoflavones were also different from controls, but these also were within either the range

of commercial values or th e 99% tolerance level for commercial soybean (Monsanto, 2010b).

MON 87769 soybean was produced to make av ailable 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 (Monsant o, 2010b). The key contribution that SDA provides is that of a precursor for the fatty acids DHA and EPA, which have been shown by a variety of clinical and re search reports to reduce adve rse cardiovascular incidents, reduce inflammatory mediators, reduce cancer ri sk and inhibit tumor growth (see review90 in Whelan, 2006). EPA alone may influence these outcomes, but administration of SDA can equal the impacts on these condit ions (see review in Whelan, 2006).

The Preferred Alternative imp acts to human health differ fr om the No Action Alternative with regard to potential human health benef its associated with consumption of the oil from this crop. APHIS’ analysis and Mons anto’s data (Monsanto, 2010b) suggest that enhancing food oils with the soybean oil extracted from the MON 87769 soybean may have a positive impact on human health when us ed 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 continge nt upon the market share of the MON 87769 soybean and the types of food products to whic h manufacturers add th e modified oil.

Based on APHIS’ analysis of field and laborator y 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 nonregul ated status of MON 87769 soybean would have no significan t impacts on human health.

Worker Safety

If MON 87769 soybean is adopted, growers during the course of production will be exposed to the same pesticides as those t ypical of other non-herbic ide tolerant soybean varieties. As MON 87769 soybean does not requ ire different cultivation practices than currently available glyphosate-tolerant soyb ean, 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. Th e novel fatty acids stearidonic and gamma linolenic acid derive from two enzymes (des aturases) that are conserved across plant, animal and bacterial kingdoms, and which ar e 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 (Monsan to, 2010b). The oils found in MON 87769 soybean, including the novel ones, are also co mmonly 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 so urces (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 processi ng 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).91 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 char acteristics to meet specific feed needs (Monsanto, 2010c). In these cases, the soyb ean meeting those sp ecialized needs are cultivated as a specialty soybean crop. The cultivation prac tices necessary to maintain identity protection have been previ ously 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 appli cable legal and regulatory requirements. GE organisms for feed may undergo a volun tary consultation process with the FDA prior to release onto the market. Monsanto initiated the consultation process with FDA

for the commercial distribution of M ON 87769 soybean and submitted a safety and

nutritional assessment of food and feed deri ved from MON 87769 soybean to the FDA on March 23, 2009 (BNF No. 00117) (Monsanto, 2 010b). 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 va rieties, both conventional vari eties 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 the Plant Protection Act expressing herbicid e 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 characteri stics of MON 87769 soybean to APHIS (Monsanto, 2010b). As pa rt of field trials, samples of MON 87769 soybean and conventional variety A3525 were co llected from five di fferent 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), vita mins, amino acids, fatty acids, and the antinutrient factors of soybean (which include d lectin, trypsin inhibitors, isoflavones, and phytic acid) (Monsanto, 2010b). APHIS has reviewed Monsanto’s results and has concluded that with the exception of the cha nges 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 no t expected to impa ct the value of MON 87769 soybean as an animal feed, Th e total fat content of the oil is unchanged which is only about 0.5% (minimum ) (Iowa Soybean Association, 2010). The to tal saturated fatty acids and polyunsatura ted fatty acids in MON 87769 soybean o il are similar to92 those found in c onventional soybean. FDA has agreed that the soybean oil produced with MON 87769 soybean ha s GRAS status (US- FDA, 2009a), and t hus, these oils are

not a risk to animals that consume meal. The desatura se proteins int roduced into MON 87769 soybean are similar to those found in a wide variet y of plants, fish and animals,

and have been shown to have no toxic or allergenic potentia l (Monsanto, 2010b).

Based on this information APHIS has conclu ded that a determination of nonregulated

status of MON 87769 soybean would have no signifi cant 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 th e 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 recen t years as returns on investment favored corn pr oduction (USDA-ERS, 2008). Al though acreage has declined, the yield per acre has continued to increase (USDA-ERS, 2008). S hort-season varieties have provided northern growers with the opt ion 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-ole ic 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 produc tion (USDA-ERS, 2008).

No Action Alternative: Dome stic Economic Environment

Under the No Action Alternative, MON 87769 soybean and its progeny would continue to be regulated under 7 CFR part 340. Grow ers 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 regul atory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act as we ll as conventional va rieties. Domestic growers will continue to utili ze 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 provi ded by this variety, w ould 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 acr eage (Monsanto, 2010b). Properties of MON93 87769 soybean are not likely to replace subs tantial 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 s oybean users will remain users of commodity soy oil, and small scale use of MON 87769 soyb ean oil may slowly increase in the next five years to that predicted in Monsanto’s ma rket 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 releva nt information (Appendix C; Addendum (Monsanto, 2010b)). As noted in Addendum 2 to the MON 87769 soybean petition, these groups include trade orga nizations representing oil proc essors, elevators, grain and oilseed processors, agricultural businesses a nd 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 oxida tive and heat stabil ity, acceptability of sensory properties and allowable changes in nutrition facts labelin g). The issue of impacts of misdirected MON 87769 soyb ean was analyzed. Making standard assumptions for the size of a single truck deliv ery of an IP soybean and for the smallest soybean processor holding ta nk, the total SDA content of commodity oil would be 0.8% from a single such delivery. Maximal pe rcentage 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 cas es, 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 s howed 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 soybean), the mixture would require up to 12.5% of MON 87769 soybean (Figure 1, Appendix C). Monsanto also determ ined that commodity oil would tolerate up to 15% MON 88769 Soybean without impact on formation of unacceptable levels of polar materials in commercial fryer conditi ons (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 segreg ate the crop from commodity soybean at all stages, from seed production through and in cluding handling , processing and use in a closed loop process, and to oversee a comp lete product stewardshi p plan involving all producers and users (Monsanto, 2010b).94 Mechanisms to Maintain Product Identity. Monsanto has developed a Closed Loop Stewardship System (CLSS) that will avoi d 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 vi able seed and grain production, and through storage, grain elevators, oil and meal pr ocessors, and downstream entities for product identity assessment (Appendix 2; Addendum 1 (Monsanto, 2010b)). The CLSS will require terms and conditions for quality ma nagement systems, quality assurance and quality control. After obt aining internationa l regulatory approvals for MON 87769 soybean, Monsanto will continue to refine and update the stewardship system for long term implementation. Key stakeholders will co ntinue to be consulte d 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 analyt ic 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 identi ty at all steps will be maintained because soybean sellers and oil processors are motivated to capture premium prices; routine adherence to prot ocols 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 en sure traceability requirements. Using the proposed measures, which would be establishe d 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 Monsanto Vistiv e low-linolenic variety has been available to oil users for six years, a nd 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 us ed for other identity preserved soybean production both have similariti es to the plan described he re for product stewardship of MON 87769 soybean oil. Monsanto has provide d 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 de monstrated that they would work with processors to assure adequate testing me thods and quality pro cesses 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 for95 specialty soybean products generally require adherence to specialty crop practices to preserve identity from seed production th rough harvesting, handling, and processing. A premium is paid to growers and processors fo r 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, 2002; Sundstrom et al., 2002). MON 87769 soybean is considered a specialty soybean pr oduct and will be marketed in accordance with other high-value specialty food crop pr oducts (Monsanto, 2010b). To maintain the identity of the product soybeans, gr owers cultivating MON 87769 soybean may potentially incur increased costs for produc tion 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 in corporation 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 fa tty 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 fi sh 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 pr oposes that the availability of SDA soybean will allow incorporation of th e 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 incr ease. 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 modi fied oil may also be a candidate oil for use in industrial products, since increas ed unsaturation may be useful in some applications, but the potential for th is use cannot easily be estimated.

The main variables that determine outco mes for market share will be consumer acceptance (including that of food and industr ial 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 produc ts using oil from MON 87769 soybean. In this event, increased economi c benefit would ensue to pr oducers of the novel oil.

Because these variables associated with MON 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 Soybea n. 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 fo r trans fatty acids (N SA, 2006). By 2005, it

was estimated that 80% of the U.S. s unflower acreage was planted in NuSunTM, a96 conventionally produced high-oleic variety (N SA, 2006). This transition occurred after the food industry conducted extensive studi es of food chemistry, supported by human health assessments (NSA, 2006). The usefulne ss 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, 2010c). 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 change s presented in MON 87769 soybean is a direct function of the chemical changes associated w ith the changed concentrations of the fatty acids. The beneficial results of incorpor ating SDA into consumer products and into finished manufactured foods will be a poi nt advanced by food marketers. Enough

scientific evidence is available for use of EPA, DHA (S DA 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 statem ents 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 mainta ining 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 Administrati on), 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 st ability 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 (T able 14) so that this parameter does not improve use as a biodiesel fuel over commod ity soybean oil because these fatty acids may be one factor that improves cold weat her performance (AGRA, 2009; Graef et al., 2009; Knothe, 2005; Monsanto, 2010c) performa nce. Cetane numbers, which are a measure of the ignition quality of an oil, wi ll likely be reduced compared to commodity soybean oil, since increased unsaturation depresses this va lue (see Table 7, Moser, 2009), and SDA itself and modestly increased linol enic acid both increase unsaturated fatty

acids. Lower cetane numbers would not o ffer improvements over commodity soybean

oil.

The costs of developing and managing IP specia lty 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 estimated as high as 25% above the cost of conventional crop production (Smyth and Phillips, 2002). Consumers of specialty crops also have cost burdens associated with these crops. In additi on to the costs incurred for specialty crop97 production, specialty crop consumers accrue adde d IP costs from five general activities: certifying and obtaining ingred ients; testing ingredients or final products; separating equipment and facilities; scheduling produc tion 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 variet ies. Pritchett reports that specialty soybean yields are generally hi gher than those reported for commodity soybeans, which he attributes to either the managerial talent of the specialty grower or higher land quality which is r ecognized and optimized by the grower (Pritchett et al., 2002). There is no information whether these market entry costs fo r cultivation and use of specialty soybean would be offset by in creased yields and pr emium 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 pract ices will be essential to ensure that the crop value is preserved.

In the alternative, inadve rtent 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 aci ds are high, rapid oxidation can occur in

fried foods and result in undesirable ta ste and odor (Addendum (Monsanto, 2010b)). Also, the taste commonly associated with fried food is due to the pres ence of linoleic acid (AGRA, 2009) and MON 87769 soybean will have decreased content. High-oleic acid soy oils are not considered ideal for frie d food applications ( AGRA, 2009) and high

levels of linolenic acid cont ribute to oxidation during fr ying and over extended storage times (Rosseli, 1998). If MON 87769 soyb ean were inadvertently used in high proportions for fried food applications, th e resulting food products would likely be unacceptable. As noted in the Addendum, howev er, 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 (A ppendix C: Addendum 1, (Monsanto, 2010b))

The need to maintain identity and control pr oduct 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 industr y 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 st ability (Appendix 2) a nd thus be valuable in this type of applicatio n. Vegetable oil polyols formed via epoxides are used in production of polyurethanes, When vegetable oils contain high levels of specific unsaturated fatty acids, epoxidized soybean-pr oduced oils can be produced that lead to higher quality chemicals with more hom ogeneous character (Cahoon, 2003). While the

inadvertent substitution of one specialty oil for another sp ecialty oil is highly unlikely,

the results of such an accidental substituti on in the industrial sector may nonetheless be substantial. If the IP prac tices do not maintain the iden tity of MON 87769 soybean and either conventional soy oil or other specia lty oils, desired oil composition would be compromised and the product would not meet its specifications. T hose entities crushing98 or using oil from MON 87769 soybean will be required under Monsanto’s stewardship plan to be continually monitoring fatty aci d content of oil, both upon arrival and after processing. Those oil indus try entities that do not purchase or expect MON 87769 soybean derived oil will also n eed to monitor fatty acid conten t 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 su ch as low-linolenic varieties provide the grower with a premium price as high as $1.25 per bushel (Conl ey et al., 2008) but more recently have declined to 50-60 cents per bushel (Wall aces Farmer, 2010). In 2005, when Monsanto introduced the low-linolenic soybean “Vis tive” variety, food produ cers 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 yi eld potential as well as consumer and producer preference to other modified fatty ac id soybean varieties.

Net income differentials cannot be projecte d, since the net income of soybean producers growing conventional soybean is not easily predicted (see re gional differences in years 2009-10) (USDA-ERS, 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 sim ilar to the No Action Alternative. Similar to other specialty crops cu rrently being grown under IP systems, resulting economic benefits are contingent on adherence to IP practices at all stag es 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. (USDA-ERS, 2010e). The worldwide market share is not as high. Until 2005, soybean oil was the largest s ource 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) producti on are expected to continue to grow over the next few years (USDA-ERS, 2010e). In 2009, the U.S. exporte d 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 bill ion 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 bill ion. Mexico is the second largest export
market with sales of $1.3 b illion in the same year (SoyS tats, 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; Hartne ll, 2010). China and India are predicted to import 46% of the total soybean mark et by 2018/2019 (FAPRI, 2009). The USDA has99 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 Chin a (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 al so 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 Brazil, Indonesia, and Malaysia are being brought into production for soybean and palm oil (USDA-ERS, 2009). This will increase glob al 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 (B rookes and Barfoot, 2010; Hartnell, 2010). Global gains from adoption of herbicide-tolera nt 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 herbicid e-tolerant soybean produc tion is substantially

lower than U.S. costs because Monsanto was unable to patent the technology in Argentina (Brookes and Barfoot, 2010). As a co nsequence, 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 w ould be no changes to the existing soybean

market.

Preferred Alternative: Trade Economic Environment

To support commercial introduction of M ON 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, Fo restry, and Fisheries (MAFF) and the Ministry of Health, Labor , and Welfare (MHLW); the Canadian Food100 Inspection Agency (CFIA) and Health Ca nada; the Intersectoral Commission for Biosafety of Genetically Modified Organi sms (CIBIOGEM), Mexico; the European Food Safety Authority (EFSA); and the regulator y authorities in other soybean importing countries with functioning regulatory system s. 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 cultivat ed as a specialty GE soybean variety and the SDA soybean oil will be produced and processed using a clos ed 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 ro le in the global soybean market.

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. Pr oducts 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 ma rginally 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 de termination of nonregul ated 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. Th e international market share of MON 87769 soybean as specialty variety is contingent on global vegeta ble oil market requirements, food processor acceptance, consumer preferen ce, demonstrated availability of the product, and price competitiveness (Monsanto, 2010b). However, with an inability to predict the size of these vari able 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 pr oducts, including international re strictions 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 soyb ean, are unlikely to change with a determination of nonregulated st atus of MON 87769 soybean.

A determination of nonregulated status of MON 87769 soybean will not adversely impact the trade economic environment and could pot entially 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 specia lty soybeans with101 modified fatty acid profiles. The trade econom ic impacts associated with a determination of nonregulated status of M ON 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 indivi duals or workers employed by the businesses potentially impacted by this product, including food processers and industrial users.

No Action: Social Environment

Under the No Action Alternative, there woul d be no changes from the status quo impacts on the social environment surrounding soyb ean 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

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 pr ocessed 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 cu ltivated as a specialty crop, a determination of nonregulated status of MON 87769 soybean is not expected to resu lt 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. Soyb ean 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 othe r 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 lik ely to be planted to the MON 87769 soybean. Those growers curr ently cultivating specialty soybean varieties have already invested in equipment and practices to maintain the identity of the product from seed through harvest and proces sing 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 investme nt (Iowa State University, 2008).

The soybean market also incl udes seed production, equipmen t manufacturers, handlers, and producers. Monsanto’s analysis of ag ronomic characteristic s did not identify any102 differences between MON 87769 soybean and c onventional varieties (Monsanto, 2010b). Monsanto expects that MON 87769 soybean w ould be cultivated, ha ndled, and processed consistent with existing identity protec tion practices and systems (Monsanto, 2010b). Other than equipment required to maintain id entity protection, no specialized equipment is required to cultivate, handl e, 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 (Adde ndum 1) (Monsanto, 2010b). Because other modified oil products are alrea dy present in the commodity oil market and routinely handled by processors using st andard industry processing methods and equipment, no new processes or equi pment are required to introduce MON 87769 soybean. Thus, workers in these areas are not likely to be im pacted by any major alterations of soybeans or of qualities of soybeans processed.

Monsanto has evaluated the market and tr ade applications of MON 87769 soybean, and has determined that this produc t 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 misd irected truckload of soybean, or other unit delivery at a higher le vel of processing, the consequent mixture would be less than 15%, at which level, no impacts on food ingredient labels or nutrition facts panels or changes to oxidative stab ility or food sensory properties would result (Addendum) (Monsanto, 2010b).

Potential impacts to industrial users of s oybean products are similar. Existing identity protection measures are already in place to allow industrial users to manage feedstocks and products for specific applications and need s (Smyth and Phillips, 2002; Sonka et al., 2004). No new equipment or practices ar e required to incorporate MON 87769 soybean into this industrial market. However, for indus trial users that require close tolerances in the ratios of fatty acid to en sure 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 enc ounter 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 va rieties that have various uses (Cargill, 2011; USB, 2010b). Thus, APHIS does not expect that ch anges to the social environment including workforce will be altered by entry of this variety into the soybean market.

Consistent with the above assessment of poten tial impacts to the growers, and workforce in the food processing and indus trial use categories, the impa cts of a determination of nonregulated status of MON 87769 soybean are expected to be the same as the No Action

Alternative.103 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 exam ple, 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 th at are no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of th e Plant Protection Act (i.e., “stacked” traits), incl uding drought tolerance, herb icide tolerance, and pest resistance, would be consid ered a cumulative impact.

5.1 Assumptions Used for Cumu lative Impacts Analysis

Specialty soybeans are cultivated to meet specific consumer needs. MON 87769 soybean is anticipated to be cultivated as anot her specialty soybean, offering growers and consumers an option for an omega-3 fatty aci d easily converted by human metabolism to desirable fatty acids, EPA and DHA. Herbicid e tolerant soybean is already extensively deployed in the seed market, as are a vari ety of specialty fatty acid ratios in other vegetable oil sources. No additional poten tial cumulative impacts to the commodity soybean market or the specialty soybean market can be reliably anticip ated 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 vege table 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 vegetabl e 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 provid e the opportunity for use of this product.

Stacked varieties of soybean, t hose crop varieties that may c ontain more than one trait, are currently found in the marketplace and in agricultu ral production. In the event

APHIS reaches a determination of nonre gulated status, MON 87769 soybean may be combined with non-GE and GE soybean varie ties by traditional breeding techniques. There is no assurance that MON 87769 soybean w ill 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’ regul ations 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 Plan t 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 ri sk. Predicting all potential combinations of stacked varieties is hypotheti cal and purely speculative.104 5.2 Cumulative Impacts: Acreage and Area of Soybean Production

Cumulative effects of a determ ination of nonregulated stat us of MON 87769 soybean are unlikely. While APHIS expects that this variet y will be stacked with glyphosate tolerance or other herbicide tolerance, as is a large pe rcentage (93%) of other soybean crops in the U.S., it will not lead to any significant changes in the sp ecifics of soybean production.

Neither the No Action Alternative nor a dete rmination 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 de voted 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 gene ral soybean production. The availability of MON 87769 soybean is not expected to ch ange the cultivation areas for soybean production in the U.S., and there are no anticipat ed changes to the ava ilability 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 herbicid e resistance traits (Monsanto, 2010d). Glyphosate will be the continuing cornerstone of any multiple herbicide stack, with additional resistance complementing the activit y, or allowing additional flexibility in designing weed control (Monsanto, 2010a). Th e adoption of herbicid e tolerance traits complements conservation tillage practices by allowing farmers to substitute herbicide application for some tillage operations as a weed management practice (NRC, 2010). Benbrook (Benbrook, 2009) notes that herbicide- tolerant soybean accounts for over twothirds of the total acreage devoted to genetically engineered crops.

Benbrook has reported that the adoption of herb icide-tolerant crops has resulted in an increase in the volume of herbicides app lied to crops (Benbrook, 2009). Benbrook notes

that herbicide use de clined between 1996 and 2001 apparent ly in direct response to the adoption of herbicide-tolera nt crops; however, since that time, herbicide use has increased (Benbrook, 2009). Reported increases in herbicide use refl ect an increase in

use of conventional herbicides as well as an increase in glyphosate applications as more glyphosate-tolerant crops are planted (Benbr ook, 2009). Currently, nine weeds have been identified as glyphosate-resistant, with seve n 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).

Besides glyphosate, soybean growers have ha d other herbicide-tole rant variety options for soybean production; two mechanisms fo r glyphosate resistance are offered to growers: insensitive target enzyme and in creased 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 derive d resistance to ALS105 herbicides, which may be stacked with other resistance traits (e.g., Asgrow Seed). These options allow growers to reduce dependen ce on glyphosate, especially if glyphosateresistant weeds are an important issue. A dditional strategies to avoid development of glyphosate-resistant weeds may be used by growers which include:

 Developing a diversified weed manageme nt program using herbicides with different modes of action, either c oncurrently or sequentially (NRC, 2010).

 Using the full recommended herbicide rate and proper application timing for the

most difficult to control w eeds in the field (NRC, 2010).

 Scouting the fields after herbicide applic ation to ensure that control has been achieved and to discourage weeds from re producing or proliferating vegetatively (NRC, 2010).

 Incorporating cultural pract ices such as cultivatio n, tillage and crop rotation, where appropriate (NRC, 2010).

Volunteer soybean is normally not a concern. Soybean is not winter hardy, and existing

mechanical and chemical methods are avai lable to manage the occasional volunteer soybean. Herbicides are available to contro l volunteer soybeans in corn, and wheat (above). These herbicides are suitable for post-emergent c ontrol of volunteer soybean. The challenges which growers face in mana ging glyphosate-resistant weeds is also not expected to differ between MON 87769 soybean stacked with glyphosate resistant trait and other glyphosate-tolerant varieties, and si milar 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 tole rant trait, or non-GE soybean

when not stacked with an herbicide tolerant tr ait) in terms of agr onomic characteristics, and cultivation practices would closely fo llow the herbicide tolerant GE or non-GE variety (Monsanto, 2010b). It is anticipated that herbicide use will continue the trends noted by Benbrook associated with the wide ad option of glyphosate-to lerant soybean and the emergence of glyphosate-resistant weeds. APHIS has determined that there are no past, present, or reasonably foreseeable acti ons that would aggregate with effects of the proposed action to effect changes in crop rotation, a nd pesticide use.

5.4 Cumulative Impacts: Soybean Seed Production

Based on current acreage trends, GE soybean va rieties will likely continue to dominate the soybean market. Since 2007, the GE variet ies 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 cultiva tion areas for soybean seed production in the U.S.; no cumulative effects have been identified for this issue.106 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 s oybean market. Based upon recent trend information, adding GE varieties to the market is not related to th e 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 acr eage produced will likely be only 1% of total specialty soybean acreage, assu ming that specialty soybean st ays at current estimates of 12% of commodity soybean production (M onsanto, 2010b). Based on demonstrated agronomic characteristics and cultivation pr actices, and because the market share of specialty soybean varieties is unlikely to substantially ch ange following the introduction of MON 87769 soybean, APHIS has determined that there are no past, present, or reasonably foreseeable change s that would impact specia lty soybean producers and

consumers. No cumulative effects ha ve 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 w ith other herbicide tole rant traits no longer s ubject to the regulatory requirements of Part 340 and the plant pest pr ovisions of the Plant Pr otection Act or with both (Monsanto, 2010d). Current application ra tes of glyphosate for weed control with MON 87769 soybean are not expected to change.

Although glyphosate is very soluble in water, it is strongly ad sorbed to soils; consequently, glyphosate is unlikely to leac h 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 agricultu ral basins with high glyphosate use rates, high overland runoff rates, and low flow thr ough soil, glyphosate can be readily detected in surface waters. Relying on toxicologica l data, bioaccumulation and biodegradation studies, and acute and chronic tests on fish and other aqua tic organisms, EPA however, has determined that “the potential for e nvironmental 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 M ON 87769 soybean. A determinat ion of nonregulated status of MON 87769 soybean will not change the wa ter use and irrigation practices used in commercial soybean production.107 5.8 Cumulative Impacts: Soil Quality

APHIS has not identified any cumulative eff ects to soils. Comprehensive phenotypic, agronomic, and ecological assessments conducted by the petitioner for MON 87769 soybean did not find significant differen ces between MON 87769 soybean and control soybeans for these characteristics (Monsant o, 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 (Monsant o, 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 conv entional soybean production practices.

If MON 87769 soybean is stacked with herb icide tolerance traits, persistence of pesticides in soil may be modulated by cu ltivation (see review of runoff potential in conservation tillage versus no- till and runoff potential (Warnemu ende et al., 2007)). The glyphosate tolerant trait would likely be st acked with this variety, and so glyphosate would be the predominant post-emergent he rbicide applied to MON 87769 soybean, as it is with other glyphosate tolerant soybea n. Glyphosate has been shown to rapidly dissipate from most agricultu ral 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 chem ical and physical parameters of soil.

If MON 87769 were to be stacked with the gl yphosate tolerant trait, this would present

certain environmental benefits over other herb icides that may be used for control of weeds in non-GE soybean production (Cer deira and Duke, 2006; Hin et al., 2001).

Pesticide products approved for application to emerged weed s normally are applied with surfactants. Surfactants increase the permeab ility 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 dissi pation, i.e., microbial degradation (Giesy et al., 2000) . The half-life of POEA in soil is estimated to range from 7 to 14 days (Giesy et al., 2000). On that basis, the POEA surfact ant is expected to behave similarly to glyphosate in field soil, a nd an increase in residua l soil concentrations (accumulation) of the POEA surfactant is not anticipated. Because MON 87769 soybean when stacked with glyphosate or other he rbicide tolerance does not differ in its agronomic requirements from conventional s oybean or other GE varieties expressing glyphosate tolerance, agronomic practices a ssociated with soil and land use are not expected to change with the availability of this new pl ant product. Based on these findings, and because the amount of soybean gr own in the U.S. is unlikely to change by the introduction of MON 87769 soybean, APHIS ha s determined that there are no past,108 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 cu mulative 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 expa nsion 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 cu mulative 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 doe s not anticipate any changes in soybean production practices or an expa nsion 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 safe ty has established subs tantial evidence that the MON 87769 soybean is safe for long term consumption, since no acute impacts could be identified. Dietary exposur e to the two new proteins expressed by MON 87769 is not a risk to human or animal health; the protei ns 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 feed ing damage to MON 87769 soybean and the comparator, conventional variety A3525 were observed over two years (Table I-5 and I6) (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 pr edominately 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 in109 Roundup Ready ® soybean varieties. Monsanto an ticipates that MON 87769 soybean will not replace commodity type glyphosate-tolerant soybean varieties previously found to no longer be subject to the require ment of Part 340 and the plant pest provisions of the Plant Protection Act. Rather, MON 87769 soybean will remain a minor product with limitedacreage. While any broad spectrum herbicide application has the potential to impact offsite plant communities, the impacts of planting MON 87769 soybean expressing glyphosate tolerance will not be novel or exte nsive. Accordingly, th e cultivation of MON 87769 soybean is not expected to result in an increase in th e application of glyphosate or changes in herbicide treatments when co mpared with existing glyphosate-tolerant soybean varieties that are no longer subject to the regulatory require ments of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act.

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 herbicid e glyphosate. This ge ne is commonly found in other Roundup Ready ® crops (USDA-APHIS, 2010c). No data have been presented to suggest that the in corporation of the cp4 epsps gene allows soybean to survive and reproduce without human intervention (USDA-APHIS, 2010c).

The soybean industry has identity protecti on measures in place to restrict pollen movement and gene flow between soybean fiel ds through the use of isolation distances, border and barrier rows, the staggering of planting dates and va rious seed handling, transportation, and ginning procedures (Bra dford, 2006; NCAT, 2003; Sundstrom et al., 2002). As a specialty soybean variety, MON 87769 soybean would be cultivated within these identity protection practi ces. In addition, there is no ev idence that horizontal gene transfer and expression of DN A 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.

5.13 Cumulative Impacts: Microorganisms

Cultivation of MON 87769 soybean is highly un likely to have direct toxic effects on microorganisms. The glyphosate tolerant trait would likely be stacked with this variety, and therefore glyphosate would likely be th e predominant post-e mergent herbicide applied to MON 87769 soybean, as it is w ith other glyphosate tolerant soybean. Microorganisms produce aromatic amino acids through the shikimate pathway, similar to110 that in plants (USDA-FS, 2003). Because gl yphosate inhibits this pathway, it could be expected that glyphosate woul d be toxic to microorganisms. Glyphosate use has been identified as potentially causing increases in certain disease-causing microbes (Fernandez et al., 2009; Kremer and Means, 2009). Reporte d 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 conti nuous cropping using herbicide- tolerant crops, whereas in others, application of glyphosat e correlated with increased ba cterial species (Fernandez et al., 2009). The U.S. Forest Service, while ac knowledging that in some cases, increases in soil pathogens following glyphosate treatment ca n 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 extens ively exposed to glyphosate, it is unlikely that any new organisms would be impacte d. Therefore, the likelihood of adverse cumulative effects on microorganisms follo wing the introduction of MON 87769 soybean

is minimal.

5.14 Cumulative Impacts: Biodiversity

Cultivation of MON 87769 soybean is highly un likely to have direct toxic effects on nontarget animals and microorganisms and is likel y to be neutral to biodiversity compared with conventionally managed GE and non-GE s oybean. 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 th e introduction of MON 87769 soybean is

minimal.

The use of genetically modified soybean su ch as MON 87769 soybean when stacked with glyphosate tolerance may improve biologica l diversity by providing growers the opportunity to use conservation practices. Incorp oration of herbicide tolerance in the crop facilitates the grower adop tion of conservation and no-till strategies, improved soil porosity, enhancing soil fauna and flora (CTIC, 2010a), increasing the flexibility of crop rotation, and facilitating stri p cropping (Fernandez-Cornejo et al., 2002), each of which

contributes to the health of the faunal a nd floral communities in and around soybean fields thereby promoting biodiversit y (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 al ready 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 agricu ltural 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 soyb ean is the same as that previously111 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 im pacts 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 produc tivity or sustainabil ity of any of the resources associated with the ecosystem in which MON 87769 soybean is planted (USDA-APHIS, 2010c).

5.15 Cumulative Impacts: Human Health

5.15.1 Cumulative Impacts: Worker Safety

MON 87769 soybean is not expected to increas e 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 nee d. To a limited extent, if stacked with an herbicide tolerant trait, MON 87769 soybean would simply replace a small percentage of

acres of the herbicide-tolerant soybean cultivars already on the market today. As APHIS analyzed in the Proposed Alternative, no hazar ds of exposure to the new fatty acids exist and therefore cumulative impacts are unlikely.

Monsanto is expected to stack MON 87769 s oybean with the glyphos ate tolerance trait (Monsanto, 2010d). 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 rapi d digestion in simulated gastri c fluids, lack of homology to known toxins and allergens, and lack of toxi city in an acute oral mouse gavage study. The lack of any documented reports of adve rse 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 glyphos ate and other U.S. EPA regi stered pesticides during conventional and GE soybean production should remain the same. If a grower replaces a non-herbicide-tolerant soybean variety w ith 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 posit ively 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.112 5.15.2 Cumulative Effects: Public Health

APHIS determined no significant adverse imp acts on human health from consumption of the oil derived from MON 87769 soybean, althou gh certain potential beneficial impacts may be possible. However, because Monsan to has decided to stack tolerance to the herbicide glyphosate with MON 87769 soybea n, APHIS considers briefly the possible impacts of the gene on human health. Sim ilar products are no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pe st provisions of the Plant Protection Act and have been used for ge neral cultivation begi nning in the mid-1990s with the introduction of Roundup Ready® pr oducts providing tole rance 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.

The CP4 EPSPS protein confers tolerance to gl yphosate. This protein is structurally homologous and similar functionally to endogenous plant EPSPS enzymes and is identical to the CP4 EPSPS in other 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 pe st provisions of the Pl ant 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 bi otechnology 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 FDA has reviewed the safety of human consumption of the CP4 EPSPS protein in MON 87769 soybean, and concluded that this protein presents negligible risk to human health from consumption (US-FDA, 2009a).

The EPA has also reviewed the safety of the CP4 EPSPS protein and has established a tolerance exemption for the pr otein 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 th at 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 CP 4 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.113 5.16 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 tra it. The gene for the trait expresses the CP4 EPSPS protein, derived from Agrobacterium sp., to achieve glyphosate he rbicide tolerance. The U.S. EPA has reviewed the safety of th e CP4 EPSPS protein and has established a tolerance exemption for the pr otein 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 th at 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.

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.

5.17 Cumulative Impacts: Domestic Economic Environment

MON 87769 soybean is intended to be cultivat ed as a specialty soybean product and its oil fraction will be produced and used w ithin 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 producer s to replace existing specialty soybean varieties to plant MON 87769 soybean as a new specialty oilseed product.

Agronomic and phenotypic analyses conducte d by Monsanto did not demonstrate any

substantial differences between MON 87769 s oybean and conventional varieties. No new agronomic characteristics providing be nefits 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, conti ngent upon market acceptance and consumer demand, and specific applications of the specialty products.

In the food supplements market, MON 87769 soyb ean has the potential to displace fish oils (containing stearidonic a nd higher level omega-3 fatty acids) and also some other non-soy oil crops that may produce SDA (A ddendum 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 prov ide SDA containing oils for large scale use in various manufactured f oods, and baked products will likely expand114 business opportunities. These sp ecifically will include supp lementing existing oils used in functional foods and healthful products.

For the past decade, soybean oil has consis tently 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 pr oduction costs of the oil low. If MON 87769 soybean oil achieves market a cceptance, the product has th e potential to marginally displace other vegetable food o ils, including other soybean, canol a, or sunflower oils in certain specialized products, a nd then most likely as a suppl ement, and consequently may not completely replace other oils in existing formulations for those products. Given that a determination of nonregulated status of M ON 87769 soybean is not ex pected to lead to an expansion of U.S. soybean acreage or s ubstantial changes in oil products industry, APHIS determines no significant impacts from production of MON 87769 soybean and no cumulative impacts.

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).

5.18 Cumulative Impacts: Trade Economic Environment

Contingent upon producer and consumer accep tance, 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-soybean115 vegetable oils on the international market. C onsistent 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.

5.19 Cumulative Impacts: Social Environment

The planting and production of oils deri ving from MON 87769 will not change the percentage of growers who plant specialty s oybean 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 bus inesses, 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 aggreg ate with the effects of the proposed action to impact the social environment surrounding soybean farming.116 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 preven t 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 Fisherie s Service (NMFS), other Federal, State, and local agencies, Tribes, non-governmental or ganizations, and privat e 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 de struction, modification, or curt ailment 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 fact ors affecting its survival.

Once an animal or plant is added to the lis t, in accordance with the ESA, protective measures apply to the species and its habita t. These measures include protection from

adverse effects of Federal activities.

Section 7 (a)(2) of the ESA requires that Fe deral agencies, in consultation with USFWS and/or the NMFS, ensure that any action they au thorize, fund, or carry out is not likely to jeopardize the continued existence of a liste d species or result in the destruction or adverse modification of designated critical habita t. It is the respons ibility of the Federal agency taking the action to assess the eff ects of their action and to consult with the

USFWS and NMFS if it is determined that th e action “may affect” listed species or

critical habitat. To facilitate APHIS’ ES A consultation process, APHIS met with the

USFWS from 1999 to 2003 to disc uss factors relevant to AP HIS’ regulatory authority and effects analysis for petitions for nonre gulated status, and de veloped a process for conducting an effects determination consiste nt with the Plant Protection Act of 2000 (Title IV of Public Law 106-224). This proc ess 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 Secti on 7 of the ESA for biotec hnology regulatory actions.

APHIS’ regulatory authority for GE organi sms under the PPA is limited to those for which it has reason to believe might be a pl ant pest or those for which APHIS does not117 have sufficient information to determine that the GE organism is unlikely to pose a plant pest risk (7 CFR § 340.1). Af ter completing a plant pest ri sk analysis, APHIS concluded that MON 87769 soybean does not pose a pl ant 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 pl ant pest provisions of the PPA, the regulations codified in 7 CFR part 340, and the biotechnology regulatory policies in the Coordinated Framework. Nevertheless, APHIS has chosen to analyze the potential effects to threatened and endangered species and critical habitat under th e ESA. As part the environmental review process, APHIS thoroughly reviews genetically engineered product information and data to inform the ESA effects analysis and, if n ecessary, 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 pe st provisions of the Plant Protection Act of 2000 and implementing regulations in 7 CFR part 340. For each transgene(s)/transgenic plant the follow ing 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 re spect to its structure and function and the nature of the organism from which it was obtained;

 A determination of where the new tran sgene and its products (if any) are produced in the plan t and their quantity;

 A review of the agronomic performance of the plant including disease and pest susceptibilities, weediness potential, a nd 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 sp ecies (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 designa ted critical habitat a nd habitat proposed for designation (See Appendix B). Based upon th e scope of the EA and production areas

identified in the Affected Environment sec tion 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/stateListingA ndOccurrence.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 and118 phenotypic differences between MON 87769 soyb ean and conventional soybean; there is no reason to believe that MON 87769 soybean is different from the commercial variety from which it was developed (USDA-APHIS, 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 wh en 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 s oybean fields because the habitat would not be suitable. Some animal species, particularly migratory birds, may vi sit soybean fields, but their presence would be a passi ng one as the habitat is eith er not suitable or does not contain constituent elements required by the sp ecies. It is reasonable to assume that populations of the species adjacent to soyb ean 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 rele vant to APHIS’ analysis.

Monsanto measured compositional aspects of MON 87769 soybean and compared these data with conventional soybea n. 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 pr oduction 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 obs erved 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 w ithin the typical co mmercial 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 carbohydrat e) and two isoflavones were also different from controls (US-EPA, 1993b), but these al so were within ei ther 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 poses119 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 dete rmined 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 trig gered (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 87768 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 tolera nce trait), and as a resu lt, APHIS has decided to conduct a cumulative NEPA impact analysis of this potential futu re action on TES.

The U.S. EPA has published an ex emption from tolerance for the cp4 epsps gene and the material necessary for its production in a ll 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 imp acts 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.

The U.S. EPA has conducted a review of the potential impacts of glyphosate to nontarget species, and has determined that when used in accordance with the FIFRA label, the potential impacts to non-targ et species is not significan t (US-EPA, 1993a, 1993b). As the action agency for pesticid e registrations, U.S. EPA has the responsibility to conduct an assessment of effects of a registrati on 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 ec ological risks from use of a currently registered pesticide, U.S. EPA evaluates extensive e xposure and ecological effects data to determine how a pesticid e will move through and break down in the environment. Risks to birds, fish, invert ebrates, mammals and plants are routinely

assessed and used in U.S. EPA’s determinati ons of whether a pesticide may be licensed

for use in the U.S.

U.S. EPA’s core pesticide risk assessment and regulat ory processes ensure that protections are in place for all populations of nontarget species, including TES. These assessments provide U.S. EPA with informati on needed to develop label use restrictions120 for the pesticide. These label restrictions carry the weight of law and are enforced by U.S. EPA and the states (Federal Insectic ide, 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 wh ether 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 "effect s determination" in

accordance with Section 7 (a)(2) of the ESA.

As a part of U.S. EPA’s TES effects assessm ent for the California red-legged frog (USEPA, 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, aq uatic invertebrates, aquatic plants, birds, mammals, and terrestrial i nvertebrates. 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 tole rant crops imposed under author ity 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 pot ential for drift to adjacent sensitive areas (e.g., residential ar eas, bodies of water, known habitat for threatened or endangered species, non-targ et crops) is minimal (e.g., when wind is blowing away from the sensitive areas).” Th is requirement should protect TES that may be at risk from exposure to glyphosate.

To facilitate pesticide applicator adheren ce to U.S. EPA label use restrictions for glyphosate, Monsanto has designed a web-ba sed program (www.Pre-Serve.org), designed to ensure no effect of glyphosate applica tions on threatened and endangered plant species. Pre-Serve instructs growers to observe specific precautions including buffer zones when spraying glyphosate herbicides on glyphosate-tolerant cr ops near threatened and endangered plant species that may be at risk. In addition, label requirements for Monsanto’s Roundup® formulations and gl yphosate formulations marketed by other manufacturers prohibit applica tion in conditions or locati ons 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 reduc e the possibility of exposure and adverse impacts to TES from glyphosate application. U.S. EPA has cons idered potential imp acts to TES as part of their registration and labeli ng process for glyphosate; and adherence to U.S. EPA label use restrictions by the pesticide applicator wi ll ensure that the use of glyphosate will not121 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 e xpected to result in an increase in the application of glyphosate or ch anges of any other herbicide treatments when compared with existing herbicide- tolerant and non-GE soybean varie ties. APHIS has determined that there are no past, present, or reasonabl y foreseeable actions that would aggregate with effects of the proposed action on TES.122 7 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND

TREATIES RELATING TO ENVIRONMENTAL IMPACTS

7.1 Executive Orders with Domestic Implications

The following executive orders require consid eration 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 P opulations 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 par ticipation in or be nefiting from such programs. It also enforces existing stat utes to prevent minority and low-income communities from being subjected to disp roportionately high and adverse human

health or environmental effects.

 EO 13045, “Protection of Children from Environmental Health Risks and Safety Risks,” acknowledges that children may su ffer disproportionately from environmental health and safety risks because of their developmental stage, greater metabolic activity levels, and behavi or 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, a ssess, 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 dispr oportionate adverse effect on minorities, lowincome populations, or children.

Based on the information submitted by the applicant and assessed by APHIS, MON 87769 soybean is agronomically, phenotypicall y, and biochemically comparable to conventional soybean except for the intended uni que 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 categorie s 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 va lue and assure its use in a ppropriate food applications. Additionally, the defatted soybean meal from MON 87769 soybean is compositionally similar to other defatted commodity soybean me al and will be used in a manner similar to123 the meal derived from these commodity soybea n. This information establishes the safety of MON 87769 soybean and its products to hum ans, including minorities and low income populations who might be exposed to th em through agricultura l production and/or processing. No additional safety pre cautions would need to be taken.

None of the impacts on agricultural practi ces expected to be associated with a determination of nonregulated status of MON 87769 soybean are expected to have a disproportionate adverse effect on mi norities 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. D ue to the lack of pesticidal and herbicidal traits in MON 87460 Soybean, soybe an hybrid varieties may be produced with MON 87769 soybean and other nonregulated soybean hybrids containing herbicide tolerant traits. Thus, pes ticide application practices a nd usage associated with a determination of nonregulated status of MON 87769 soybean ar e not expected to change

from the current trends for ex isting nonregulated GE soybean.

The following executive order addresses Federal responsibilit ies 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 inva sive 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 va rieties and the data submitted by the applicant and reviewed by APHIS, MON 87769 soybean are sufficiently

similar in fitness characteristics to other s oybean varieties curren tly grown and are not expected to become weedy or i nvasive (USDA-APHIS, 2010c).

The following executive order requires the pr otection of migratory bird populations:

EO 13186 (US-NARA, 2010b), “Responsibili ties of Federal Agencies to Protect Migratory Birds,” states that federal agencies taking actions that have, or are likely to have, a measurab le 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 conserva tion of migratory bi rd populations.

Monsanto has presented results of field tr ials conducted to eval uate field phenotypic, agronomic and environmental interactions. These data, presente d 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 to124 impact food sources for mi gratory bird species. Migrat ory 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, apar t 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 consider ation and does not expect a significant environmental impact outside the U.S. in th e event of a determination of nonregulated

status of MON 87769 . All existing national and internat ional 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 und er 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 phytosa nitary requirements and be in accordance with phytosanitary standard s developed under the International Plant Protection Convention (IPPC, 2010). The purpose of the IPPC “is to secure a common and effective action to preven t the spread and introduction of pests of plants and plant products and to promote appropriate measur es for their control” (IPPC, 2010). The protection it affords extends to natural flora and plant produc ts and includes both direct and indirect damage by pest s, including weeds.

The IPPC establishes a standard for th e 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 meeti ng of the governing body of the IPPC as a supplement to an existing standard, Internati onal Standard for Phyt osanitary Measure No.125 11 (ISPM-11, Pest Risk Analysis for Quarantin e 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 LM O 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 comme rcialization and trans boundary 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 establishe d a framework for the safe transboundary movement, with respect to the environmen t 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 tran sboundary movement of LMOs intended for environmental release (field trials or comme rcial planting) will require consent from the importing country under an advanced informed agreement (AIA) provision, which includes a requirement for a risk assessment c onsistent 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 Bi osafety 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. Gove rnment has developed a website that provides the status of all regulatory re views completed for different us es of bioengineered products (NBII, 2010). These data will be available to the Biosafety Clearinghouse.

APHIS continues to work toward harm onization of biosafet y and biotechnology consensus documents, guidelines, and regula tions, 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 th e Regional Standards for Phytosanitary Measures (RSPM) No. 14, Importation and Release into th e 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 biotec hnology issues for the U.S., Mexico, and Canada. In addition, bila teral discussions on biotechnology regulatory126 issues are held regularly with other countries including Arge ntina, Brazil, Japan, China,

and Korea.

7.2 Compliance with Clean Water Act and Clean Air Act

This EA evaluated the changes in s oybean 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 wa ter 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 th at the cultivation of MON 87769 soybean would inherently comply with the Clean Water Act and the Clean Air Act.

7.3 Impacts on Unique Characte ristics of Geographic Areas

A determination of non-regulated status of MON 87769 soybean is not expected to impact unique characteristics of geographic ar eas 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 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 distur bances; no new physical destruction or damage to property; no alterations of prope rty, wildlife habitat, or landscapes; and no prescribed sale, lease, or tran sfer of ownership of any prope rty. This action is limited to a determination of non-regulated 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 prac tices for land preparat ion, 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 Ac t (NHPA) of 1966 as Amended

The NHPA of 1966 and its implementing regul ations (36 CFR 800) require Federal agencies to: 1) determine whether activitie s they propose constitute "undertakings" that have the potential to cause eff ects on historic properties a nd 2) if so, to evaluate the127 effects of such undertakings on such historic resources and consu lt with the Advisory

Council on Historic Preservation (i.e., State Historic Preserva tion 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 potenti al conflict with cultural resources on tribal properties.

A determination of nonregulated status of MON 87769 soybean would have no impact on districts, sites, highways, stru ctures, 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 non-regulated status of MON 87769.

A determination of nonregulated status of MON 87769 soybean is not an undertaking that may directly or indirectly cau se alteration in the character or use of historic properties protected under the NHPA. In general, common agricultural activ ities conducted under this action do not have the potential to introdu ce visual, atmospheric, or noise elements to areas in which they are used that could result in effects on the characte r or use of historic properties. For example, th ere 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 ef fects on the audible na ture of a site and can be ended at any time to restore the audibl e qualities of such sites to their original

condition with no further adverse effects. Additionally, these cult ivation 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.128 8 REFERENCES

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## Appendix A

FDA Substances Generally Recogn ized as Safe (GRAS) – Agency Response Letter GRAS Notice No. GRN 000283158159 

### 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’s160 GRAS 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), 6 th Edition, for conventional
soybean oil. Specifications include fatty acid composition, stability, limits for free fatty161 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 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 90 th 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 90 th 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 90 th 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 90 th 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.162 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

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 health

‐ related 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.163 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 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,164 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

1 Reference amounts customarily consumed (21 CFR 101.12)

2 Monsanto 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.165 

## Appendix B

APHIS Threatened and Endangered Species

Decision Tree for FWS Consultations166
Template Last Revised on July 11, 2006 

### DECISION TREE ON WHETHER SE CTION 7 CONSULTATION WITH

FWS IS TRIGGERED FOR PETI TIONS OF TRANSGENIC PLANTS

This decision tree document is based on the phenot ypes (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 follo wing 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 weedin ess potential of the crop plant and its sexually compatible relatives;

 Characterization of each transgene with re spect 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, a nd agronomic and environmental impact;

 Determination of the concentrations of know n plant toxicants (if any are known in the plant),

 Analysis to determine if the transgenic plan t 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 fr om new plant varieties, including those derived from transgenic plants (h ttp://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 st andards as is required of all other foods. Many of the food crops currently being developed usi ng biotechnology do not cont ain substances that are significantly different from those alrea dy consumed by human and thus do not require pre-market approval. Consistent with its 1992 po licy, FDA expects developers to consult with the agency on safety and regulatory questions . A list of consultati ons is available at http://vm.cfsan.fda.gov/~lrd/b iocon.htmlhttp://vm.cfsan.fda .gov/~lrd/biocon.html. APHIS

considers the status and conclusion of the FDA consultations in its EAs.

Below is a description of our review process to whether a consultation with U.S. Fish and Wildlife Service is necessary.167 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 plant 2 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 metabolite s have any significant similarities to known

toxins 3 )?

4) Will the new phenotype(s) imparted to the transg enic plant allow the plant to be grown or employed in new habitats (e.g., outside agro-ecosystem) 4 ?

5) Does the pest resistance 5 gene 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 spr ead of the pest in the host plant (e.g., the production of lignin, callose, thic kened cuticles); In the plant by inactivating or resisting t oxins or other disease causing substances produced by the pest; By creating a deficiency in th e host of a component required for growth of the pest (such as with fungi and bacteria); 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 interferi ng with normal growth, development, or behavior of the pest; B. A pest derived transgene is ex pressed in the plant to confer re sistance 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

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 transg ene’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.168 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 accord ance with a process mutually agreed upon

with the U.S. Fish and Wildlife Servi ce to determine when a consultation, as required under Section 7 of the Endangere d Species Act, is needed. APHIS has

reached a determination th at 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 accord ance with a process mutually agreed upon

with the U.S. Fish and Wildlife Servi ce to determine when a consultation, as required under Section 7 of the Endange red Species Act, is needed. APHIS

reached a determination th at the release following a determination of nonregulated status is not likely to adve rsely affect any listed threatened or endangered species and consequently obtai ned written concurrence from the Fish

and Wildlife Service.

________ BRS has reviewed the data in accord ance with a process mutually agreed upon

with the U.S. Fish and Wildlife Servi ce to determine when a consultation, as required under Section 7 of the Endange red Species Act, is needed. APHIS

reached a determination th at the release following a determination of nonregulated status is likely to affect adversely one or more listed threatened or endangered species and has initiated a fo rmal consultation with the Fish and

Wildlife Service.169 

## Appendix C

Petition for the Determination of Nonregulated Status for

MON 87769 – Addendum

Potential Market Im pact of MON 87769170 

## Petition for the Determination of Nonregulated Status for

MON 87769

ADDENDUM

Potential Market Impa ct of MON 87769

Submitted July 1 st 

## , 2011

OECD Unique Identifier: MON-87769-7

Monsanto Petition Number: 09-183-01p171 

### 1.0 Introduction

Monsanto has developed biotechnology-deri ved soybean MON 87769 (SDA soybean) that
contains stearidonic acid (SDA), a sustainable alte rnate source of an omega-3 fatty acid to help
meet the need for increased dietary intake of l ong chain omega-3 fatty acids. In mammals, SDA
is a metabolic intermediate in the prod uction of eicosapentae noic acid (EPA) and
docosahexaenoic acid (DHA) from alpha linolenic acid (ALA), a common dietary constituent.
Refined oil produced from MON 8 7769 contains approximately 20 to 30% SDA (wt% of total
fatty acids) and can be included in a range of f ood products for health benefits. The oil from
MON 87769 (SDA soybean oil) is Generally Recogni zed As Safe (GRAS) in the United States
and can be used for the producti on of products such as margarin e, shortenings, salad dressings,
ready-to-eat foods, and othe r food categories specified in the GRAS notification 6

. MON 87769 is a specialty trait soybean, not deve loped 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 prod uct to market, Monsanto will adhere to the
Biotechnology Industry Organi zation’s (BIO’s) Product La unch Stewardship policy 7 , including
its Annex 2: “Specialty Use Tr aits 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 wh ich could be anticipated within the value chain
due to the introduction of SDA soybean. Th e defatted soybean meal from MON 87769 is
compositionally similar to other commodity defatte d soybean meal and will be used in a manner
similar to commodity soybean meal. The o il 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 co mmodity soybean oil, SDA soybean oil contains
two additional fatty acids, SDA and GLA. SDA s oybean oil is intended for use only in certain
markets. The presence of this oil in markets where it is not in tended 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).

Monsanto will utilize and implement the CLSS throughout the initial product introduction phase,
at least until approvals are received from ke y soybean export countr ies with functioning
regulatory systems. After such approvals are received, Monsanto will, based on the experiences

6 http://www.accessdata.fda.gov/scrip ts/fcn/gras_notices/grn000283.pdf

7 http://www.bio.org/letters/Product _Launch_Stewarship_12_10_09.pdf172 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 inte nded 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 o il. This document also describes the CLSS
which Monsanto will implement during the initial phase of th e product introduction.



### 2.0 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 generall y recognized as safe in

the United States 8

. 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 reco gnized, typical Western di ets 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 wi der range of foods th at are enriched in
omega-3 fatty acids so that peop le can choose foods that suit thei r 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 acid s in food. SDA soybean oil can be used for the production of
margarine, shortenings, salad dr essings, ready-to-eat foods, and other food categories described

in the GRAS notification 9 . The use of SDA soybean oil in selected food categories could
provide a wide range of dietar y alternatives for increasing omega-3 fatty acid intake.

Given the targeted commercial a pplication of SDA soybean as an alternate source of omega-3
fatty acids in food it is anticipated that MON 87769 will be a low ac reage 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 preser ved to maintain its value and assure its use in
appropriate food applications. The co-produc t, soybean meal, derived from MON 87769 has

8 http://www.fda.gov/Food/FoodIngredientsPackaging/Gene rallyRecognizedasSafeGRAS /GRASListings/ucm185688.htm

9 http://www.accessdata.fda.gov/scr ipts/fcn/gras_notices/grn000283.pdf173 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 w ould be limited to those applications that
demonstrate (1) functional suitability for incor poration into food products, (2) acceptable sensory
properties (no off-flavors or bad taste) to the food, and (3) appropr iate 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 contai ns high levels of SDA (approximately 20-30
wt% of total fatty acids). Vegetable oils contai ning high levels of poly unsaturated fatty acids
(PUFUs) like SDA are known to u ndergo rapid oxidation during frying applications and will
impart undesirable taste and odor to the fried f oods. Therefore, SDA soybean oil will not be
suitable for all food applications and may not be su itable 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 l ong 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 mixe s, breakfast cereals
and grains, cheeses, dairy product analogs, fats and oils, fish pr oducts, frozen dairy desserts and
mixes, grain products and pastas, gravies an d sauces, milk products, nuts and nut products,
poultry products, processed fruit juices, proc essed vegetable products, puddings and fillings,
snack foods, soft candy, and soups and soup mixes 10

. 

### 3. Market Potential of SDA Soybean

Consumer demand for long chain omega-3 fatty aci ds through food and suppl ements 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 Analys is of the North American Marine and Algae
Oil Omega-3 Ingredients Market , Frost & Sullivan, March 2010 11 ). The value added product
derived from MON 87769 is SDA soybean oil. S DA soybean oil provides increased alternatives
for food companies to formulate omega-3 fatty ac ids into a wider range of foods. Because SDA
soybean oil can be used in wide r food categories, Monsanto estim ates, for the purposes of this
analysis that the industry growth of omega-3 o ils in functional foods could increase by 26.6%.
For the purposes of this analys is, Monsanto assumed that SDA soybean oil could capture 100%
of that incremental growth, which, given ma rket 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

10 FDA Food classifications 21 CFR §170.3(n).

11 http://www.frost.com/prod/ servlet/report-brochure. pag?id=N73E-01-00-00-00174 expected that about 7.5 times the volume of SDA s oybean oil might be need ed to satisfy the EPA
equivalent amount currently provided by other mari ne 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 w ould be approximately 20,000 MT.
Furthermore, assuming an averag e oil yield of 0.2 MT/acre for s oybean, 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 o il exports. The United States is the largest
producer of soybeans and regularly exports soybean and soybean pr oducts 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 stewardship 12 and adhere to the BIO Product Launch
Stewardship Policy 13 . In compliance with BIO's Product Launch Stewardship Policy, Monsanto
considered Annex 2 “Special Use Traits in Co mmodity Crops” to develop launch plans for SDA
soybean including: (1) identifying relevant stakeh olders for the trait a nd crop and engaging them
in dialogue and outreach regarding use of SD A soybean, (2) conducting a market and trade
assessment to evaluate the potential impact fr om the introduction of MON 87769 to the market
place, and (3) implementing a closed loop stewar dship 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 indus try stakeholder groups and has held several
meetings with the National Oil Processors Asso ciation (NOPA) as well as other key industry

associations such as the North American E xport Grain Association (NAEGA), National Grain
and Feed Association (NGFA), National Agri -Marketing Association (NAMA), American
Bakers Association (ABA), and Grocery Manuf acturers Association (GMA ). Soybean grower
organizations consulted include: American Soyb ean Association (ASA), United States Soybean
Board (USB), and many state soybean associ ations. 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 inpu t of several soybean and food industry key
stakeholders regarding the oil composition, st ewardship plan and performance of MON 87769

oil.

12 http://www.monsanto.com /ourcommitments/pages/p roduct-stewardship.aspx

13 http://www.bio.org/letters/ Product_Launch_Stewarship_12_10_09.pdf ;175 Monsanto has been marketing specialty Vistiv e 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 te sting 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 pr inciples 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 produ ced 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 use 14 . These
soybean varieties are specified by buyers and en d-users of soybean for production, and premiums
are paid for delivering a product th at meets purity and quality standa rds 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 a nd market segmentation in the
specialty soybean industry includ es mechanisms to keep track of the soybean (traceability),
methods for identity preservati on (IP), including closed-loop st ewardship systems, and quality
assurance processes (e.g., ISO9001- 2000 certification), as well as contracts between growers and
buyers that specify delivery agreemen ts within product specifications.

Monsanto has conducted a market and trade asse ssment to anticipate and consider the potential
impacts within the value chain from the in troduction of SDA soybean, and to commodity
soybean oil as well as other vegetable oil in th e market place. Soybean is a globally traded
commodity with the U.S. being the top global producer 15 . Biotechnology-derived crops are
subject to regulati on in many countries. In order to suppor t free trade in soyb ean, Monsanto is
pursuing regulatory approval for MON 87769 and any stack ed products intended for
commercialization in all key soyb ean export countries with a functioning re gulatory system.
International regulatory authorities are evalua ting the food and feed safety of MON 87769 as
well as the processed fractions derived from M ON 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 therefor e 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 prev ent the comingling of SDA soybean or oil with
commodity products. The market and trade asse ssment 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

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.htm176 impacts of inadvertent comingling of SDA soybea n, 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 ve getable oil markets. As discu ssed 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 ve getable oils that are
currently available for various f ood applications. The comingling levels where an impact would
occur could only happen if there were a major devi ation in the system which is highly unlikely as
routine analytical methods are in place. A dditionally, there is economic motivation, legal
contracts, standard operating procedures (seed quality to end user), and demonstrated
competency handling other vegetable o ils 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 deliver y. Further, comingling can be identified via
routine fatty acid analysis or QC checks before th e oil is shipped from th e 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 o il with SDA soybean o il should be identified
prior to loading for export shipment, which mini mizes commingled oil arriving at an exporting

country.

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 gr oss 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 le ss 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 fina l SDA concentration of 0.8% SDA in commodity
soybean oil. The presence of 0.8% SDA in commodity soybean oil will have no impact to177 human health because the oil has been through the food safety assessment 16 . 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 comm odity soybean in a grain storage bin that
typically holds 100,000 to 500,000 bushels of soyb ean, 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 rangi ng from 0.03% to 0.16% of total fatty acids.

Soybeans are exported as whole beans or as pr ocessed fractions. Soybean oil is commonly
exported via cargo ships in containers with a ca pacity 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, th e chance of SDA in soybean oil entering into the
export market unintentionally is very small.

Commodity soybean shipped for export are typica lly 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 commod ity soybean reaches a destination country, the
inadvertent delivery of a truc k 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
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 vegeta ble oil (0.05%).



### 4.2.2 Potential Impact to Commodity So ybean 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 m eal 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 cont ain 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, th e soybean meal and other non-oil processed fractions
used for animal feed and human food applica tions 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 co mingled with commodity soybean meal in the
market place. Therefore no trade impact is an ticipated from the comm ingling of SDA soybean
meal with commodity soybean meal.

16 http://www.fda.gov/Food/FoodIngredientsPackaging/Gene rallyRecognizedasSafeGRAS /GRASListings/ucm185688.htm178 

### 4.2.3 Potential Impact to Commodity Soybean Oil in the Market Place

Monsanto has assessed the impact due to the pr esence of SDA soybean oil on commodity and
other vegetable oils.

Areas of potential impact iden tified include the following: (1) food ingredient labeling, (2)
nutritional facts panel labeling (3 ) functionality of th e oil, and (4) sensory evaluation. This
assessment has been shared with key stakehol ders such as NOPA, NAEGA, ASA, QUALISOY,

USB and GMA.

Food Ingredient Labeling:

The impact due to the presence of SDA soyb ean oil in commodity soybean oil from the
perspective of soybean oil ingr edient labeling was considered. SDA soybean oil contains two
additional fatty acids (SDA and GLA) that are not present in commod ity soybean oil. Therefore,
we evaluated the potential im pact to food ingredient labe ling if SDA soybean oil was
inadvertently present in the soybean oil that is added to food.

The U.S. Food and Drug Administra tion requires that all ingredie nts present in a food to be
declared with a few exceptions. Although the regu lations 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 “incid ental additive” is exempt if, acco rding to the regulations, it is
present at “insignificant levels” and has no “technical or functional effect” in a food 17 . Residual
product from a previous soybean oil processing r un may occasionally be mixed into a different
product in a new run. Such re sidual product would fit the co ncept of “incidental additive” 18 and

need not be included on the label. Thus, the unintended presence of in significant 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 th e nutrition facts panel of foods.
They are (1) total fat, (2) trans fa t, and (3) saturated fat. It is voluntary for a food company to list
the amounts of monounsaturated fat and polyunsatur ated 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 provider s voluntarily list also monouns aturated and polyunsaturated
fatty acids present in the oil. Since in SDA s oybean oil one polyunsaturated fatty acid (LA) is
replaced with two other (SDA a nd GLA) polyunsaturated fatty acid s; the impact of comingling
on nutrition facts panel labeling from listing mono a nd 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 consider ed to assess the potential impact of SDA
soybean oil comingling with commodity soybean oil on nutritional facts panel labeling of bottled

17 21 CFR § 101.100

18 21 CFR § 101.100(3)i179 soybean oil. Table 1 shows the amount of S DA 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 bo ttled soybean oil. Based on th is analysis even 25% of SDA
soybean oil comingled with commodity soybean o il 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 soyb ean oil will not have any impact on the nut ritional 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 nu trition facts panel
for SDA soybean oil.

Table 1. Impact of Comingling SDA Soybean Oil with Commodity Soybean Oil on
Nutritional Facts Panel Labeling for Bottled Soybean Oil

Major Fatty Acids SBO 1 SDA

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 o il (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 pe rcentages 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 calcu lation. Mono and polyunsaturated fatty acid labeling is
voluntary. No change in trans fat.180 Figure 1. Nutrition Facts Panel for Co mmodity 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.

Oil Functionality:

Oxidative Stability Monsanto conducted an assessment of the impact of the oxidative
stability of commodity soybean oil comingl ed with SDA soybean oil. Figure 2
demonstrates that comingling of SDA soybean oil with commodity soybean oil decreases
the Oxidative Stability Index (O SI) 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, an tioxidant and pro-oxidant concentration,
and prior abuse. Oxidation is slow until th is resistance is overcome, at which point181 oxidation accelerates and becomes more ra pid. 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 OS I, and is reported in hours. The oxidative
stability of soybean oil is significantly in fluenced 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 reta il salad oil (soybean oil) obtai ned from a local St. Louis

market. Neither oils contained added antioxi dants. 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 110 o C using AOCS

Official Method Cd 12b-92. OSI was run in duplicate for each ble nd sample, and means
were averaged to obtain the data point s shown. Target blend accuracy in the
commodity/SDA soybean oil blends was conf irmed by fatty acid composition determined
using capillary gas chromatographic (GC) an alysis (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 peri od 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 ra nged 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 th is study it is reasona ble to conclude that
minor levels of SDA will not impact the OS I 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.182 Figure 2. Oxidative Stability Index (O SI) of SDA Soybean Oil Blended with
Commodity Soybean Oil

Heat Treatment Vegetable oils containing high le vels 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 hi gh levels of PUFAs
compared to other vegetable oils, and therefor e, 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 withsta nd 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 us e of the Ebro Food Oil Meter (E bro 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. Measur ements are taken of th e fry oil throughout the
length of the fry study to determine when th e 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 S DA soybean oil/commodity soyb ean 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 forma tion of total polar materials in the oil. •

0.05% 0.5% 5% 50% (log scale)

% SDA Oil in Commodity Soybean Oil •183 Figure 3. Hours to Reach 24% Total Polar Material During Frying Application of
Soybean Oil Containing Varying Amounts of SDA Soybean Oil

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 e nvironment of high temperature food frying applications was

evaluated as a worst case scenario. To de termine the impact S DA 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 differen ces in individual French fry attributes. A
rating of 5 indicates no difference, 4 sli ght 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 withou t impacting the flavor perception of fried
food (Figure 4). 

## 19 hours 21 hours 19 hours 19 hours 18 hours 18 hours

15... 10... 7.5... 5%... 2.5... 0%... 

# Hours to Reach 24% Total Polar

Material184