i



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

**Acid Soybean OECD Unique Identifier:**  **MON 87769 -**  **7** 

## Final **Environmental Assessment April 2012**  **Agency Contact Cindy Eck**  **Biotechnology Regulatory Services 4700 River Road**  **USDA, APHIS Riverdale, MD 20737**  **Fax: (301) 734 -**  **8669** The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, sex, religion, age, disability, political beliefs, sexual orientation, or marital or family sta tus. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact USDA’S TARGET Center at (202) 720

–2600 (voice and TDD). To fi le a complaint of discrimination, write USDA, Director, Office of Civil Rights, Room 326

–W, Whitten Building, 1400 Independence Avenue, SW, Washington, DC 20250

– 9410 or call (202) 720

– 5964 (voice and TDD). USDA is an equal opportunity provider and employer . Mention of companies or commercial products in this report does not imply recommendation or endorsement by the U.S. Department of Agriculture over others not mentioned. USDA neither guarantees nor warrants the standard of any product mentioned. Produ ct names are mentioned solely to report factually on available data and to provide specific information.

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

**TABLE OF CONTENTS** LIST OF TABLES ................................ ................................ ................................ ........... VII LIST OF FIGURES ................................ ................................ ................................ ......... VII ACRONYMS AND ABBREVIAT IONS ................................ ................................ ...... VIII 1 PURPOSE AND NEED ................................ ................................ .............................. 1 1.1 Regulatory

Authority ................................ ................................ ............................ 1 1.2 Regu lated Organisms ................................ ................................ ........................... 2 1.3 Petition for Determination of Nonregulated Status: MON 87769 Soy bean ......... 2 1.4 Purpose of Product ................................ ................................ ............................... 3 1.5 APHI S Response to Petition for Nonregulated Status ................................ ......... 5 1.6 Coordinated Framework Review ................................ ................................ ......... 6 1.6.1 U.S. Environmental Protection Agency ................................ ........................ 6 1.6.2 Food and Drug Administration ................................ ................................ ..... 6 1.7 Public Involvement ................................ ................................ .............................. 7 1.8 Issues Considered ................................ ................................ ................................ . 7 2 AFFECTED ENVIRONMENT ................................ ................................ .................. 9 2.1 Soy

bean Products and Composition ................................ ................................ ..... 9 2.1.1 Soy

bean Use ................................ ................................ ................................ .. 9 2.1.2 Soy

bean Composition ................................ ................................ ................. 12 2.2 Agricultural Production of Soy bean ................................ ................................ ... 13 2.2.1 Acreage and Area of So ybean Production ................................ .................. 13 2.2.2 Agronomic Practices ................................ ................................ ................... 16 2.2.3 Soy

bean Seed Production ................................ ................................ ........... 23 2.2.4 Organic So ybean Production ................................ ................................ ...... 24 2.2.5 Specialty

Soy bean Production ................................ ................................ .... 26 2.3 Phy sical Environment ................................ ................................ ........................ 30 2.3.1 Water Resources ................................ ................................ ......................... 30 2.3.2 Soil Quality ................................ ................................ ................................ . 32 2.3.3 Air Qual ity ................................ ................................ ................................ .. 34 2.3.4 Climate Change ................................ ................................ ........................... 37 2.4 Biological Resources ................................ ................................ .......................... 39 2.4.1 Animal Communities ................................ ................................ .................. 39iii

2.4.2 Plant Communities ................................ ................................ ...................... 40 2.4.3 Gene Flow and Weediness ................................ ................................ .......... 41 2.4.4 Microorganisms ................................ ................................ .......................... 43 2.4.5 Biodiversity ................................ ................................ ................................ . 44 2.5 Human Health ................................ ................................ ................................ .... 47 2.5.1 Public Health ................................ ................................ ............................... 47 2.5.2 Human Dietary

Health ................................ ................................ ................ 48 2.5.3 Worker Safety ................................ ................................ ............................. 50 2.6 Animal Feed ................................ ................................ ................................ ....... 51 2.7 Socioeconomic ................................ ................................ ................................ ... 51 2.7.1 Domestic Economic Environment ................................ .............................. 51 2.7.2 Trade Economic Environment ................................ ................................ .... 56 2.7.3 Social Environment ................................ ................................ ..................... 57 3 AL TERNATIVES ................................ ................................ ................................ ..... 59 3.1 No Action Alternative: Continuation as a Regulated Article ............................. 59 3.2 Preferred Alternative: Determination that MON 87769 Soy bean is No Longer a R egulated Article ................................ ................................ ............................... 59 3.3 Alternatives Considered But Rejected from Further Consideration .................. 60 3.3.1 Prohibit Any

MON 87769 from Being Released ................................ ........ 60 3.3.2 Approve the Petition in Part ................................ ................................ ........ 60 3.3.3 Isolation Distance between MON 87769 Soy bean and Non - GE Soy

bean Production and Geographical Restrictions ................................ ................. 61 3.3.4 Requirement of Testing for MON 87769 Soy bean ................................ ..... 61 3.4 Comparison of Alternatives ................................ ................................ ............... 62 4 ENVIRONMENTAL CONSEQ UENCES ................................ ............................... 64 4.1 Scope of the Analy sis ................................ ................................ ......................... 64 4.2 Agricultural Production of Soy bean ................................ ................................ ... 65 4.2.1 Acreage and Area of So ybean Production ................................ .................. 65 4.2.2 Agronomic Practices ................................ ................................ ................... 67 4.2.3 Soy

bean Seed Production ................................ ................................ ........... 69 4.2.4 Organic So ybean Production ................................ ................................ ...... 69 4.2.5 Specialty

Soy bean Production ................................ ................................ .... 71iv

4.3 Phy sical Environment ................................ ................................ ........................ 72 4.3.1 Water Resources ................................ ................................ ......................... 72 4.3.2 Soil Quality ................................ ................................ ................................ . 72 4.3.3 Air Quality ................................ ................................ ................................ .. 73 4.3.4 Climate Change ................................ ................................ ........................... 74 4.4 Biologic al Resources ................................ ................................ .......................... 74 4.4.1 Animal Communities ................................ ................................ .................. 74 4.4.2 Plant Communities ................................ ................................ ...................... 77 4.4.3 Gene Flow and Weediness ................................ ................................ .......... 77 4. 4.4 Microorganisms ................................ ................................ .......................... 80 4.4.5 Biodiversity ................................ ................................ ................................ . 8 1 4.5 Human Health ................................ ................................ ................................ .... 82 4.5.1 No Action Alternative ................................ ................................ ................. 82 4.5.2 Preferred Alternative: Human Health ................................ ......................... 83 4.6 Animal Feed ................................ ................................ ................................ ....... 86 4.6.1 No Action Alternative: Animal Feed ................................ .......................... 86 4.6.2 Preferred Alternative: Animal Feed ................................ ............................ 87 4.7 Socioeconomic Impacts ................................ ................................ ...................... 87 4.7.1 Domestic Economic Environment ................................ .............................. 87 4.7.2 Trade Economic Environment ................................ ................................ .... 93 4.7.3 Social Environment ................................ ................................ ..................... 95 5 CUMULAT IVE IMPACTS ................................ ................................ ...................... 98 5.1 Assumptions Used for Cumulative Impacts Anal ysis ................................ ........ 98 5.2 Cumulative Impacts: Acreage and Area of Soy bean Production ....................... 98 5.3 Cumulative Impacts: Agronomic Practices ................................ ........................ 99 5.4 Cumulative Impacts: Soybean Seed Production ................................ .............. 101 5.5 Cumulative Impacts: Organic Soy bean Production ................................ ......... 101 5.6 Cumulative Impacts: Specialty Soy bean Production ................................ ....... 101 5.7 Cumulative Impacts: Water Resources ................................ ............................ 101 5.8 Cumulative Impacts: Soil Quality ................................ ................................ .... 102 5.9 Cumulative Impacts: Air Quality ................................ ................................ ..... 103 5.10 Cumulative Impacts: Climate Change ................................ .............................. 103v

5.11 Cumulative Impacts Animal Communities ................................ ...................... 103 5.12 Cumulative Impacts: Plant Communities ................................ ......................... 103 5.13 Cumulative Impacts: Gene Flow and Weediness ................................ ............. 104 5.14 Cumulative Impacts: Microorganisms ................................ ............................. 104 5.15 Cumulative Impacts: Biodiversity ................................ ................................ .... 105 5.16 Cumulative Impacts: Human Health ................................ ................................ 106 5.16.1 Cumulative Impacts: Worker Safety ................................ ......................... 106 5.16.2 Cumulative Impacts: Public Health ................................ .......................... 106 5.17 Cumulative Impacts: Animal Feed ................................ ................................ ... 107 5.18 Cumulative Impacts: Domestic Economic Environment ................................ . 108 5.19 Cumulative Impacts: Trade Economic Environment ................................ ....... 109 5.20 Cumulative Impa cts: Social Environment ................................ ........................ 109 6 THREATENED AND ENDAN GERED SPECIES ................................ ............... 111 6.1 Cumulative Impacts of Stacking MON 87769 Soybean with a Gl yphosate Tolerant Trait on TES ................................ ................................ ................................ ............. 113 7 CONSIDERATION OF EXE CUTIVE ORDERS, STAND ARDS, AN D TREATIES RELATING TO ENVIRONM ENTAL IMPACTS ................................ ............... 116 7.1 Executive Orders with Domestic Implications ................................ ................. 116 7.2 Compliance with Clean Water Act and Clean Air Act ................................ .... 119 7.3 Impacts on Unique Characteristics of Geo graphic Areas ................................ 119 7.4 National Historic Preservation Act (NHPA) of 1966 as Amended .................. 120 8 REFERENCES ................................ ................................ ................................ ....... 121 9 APPENDIX A: FDA SUSB STANCES GENERALLY RE COGNIZED AS SAFE (GRAS)

– AGENCY RESPONSE LETT ER GRAS NOTI CE NO. GRN 000283 ............. 146 10 APPENDIX B: APHIS TH REATENED AND ENDANGE RED SPECIES DECI SI ON TREE FOR FWS CONSUL T ATIONS ................................ ................................ . 152 11 APPENDIX C: PETI TI ON FOR THE DETERMINATION OF NONREGULATED STATUS FOR MON 87769

– ADDENDUM: POTENTIAL MARKET IM PACT OF MON 87769 ................................ ................................ ................................ ........... 155 12 LIST OF PREPARERS ................................ ................................ ........................... 183vivii

**LIST OF TABLES** Table 1: Fatty acid composition of conventional soy bean oil. ................................ ......... 11 Table 2: U.S. soy

bean production in Northern Tier states in 2010 . ................................ .. 1 6 Table 3 : Rank of so ybean production in Northern Tier states and the U.S. in 2007 along with other principal crops . ................................ ................................ ........ 16 Table 4 : First and second most frequent rotational crops following so yb ean . ................. 20 Table 5: Principle herbicides used in soy bean production and percentage of acres a pplied -- selected states . ................................ ................................ ...................... 2 3 Table 6: Certified organic soy bean acreage, 2007 and 2008 ................................ ............ 26 Table 7: Irrigation of soybean acres in Northern Tier states ................................ ............ 3 0 Table 8: Water sources used for irrigation of so ybean acres in Northern Tier states ....... 3 1 Table 9: Percentages of linoleic and linolenic acid in various vegetable oil sources and U.S. consumption . ................................ ................................ ........................ 48 Table 10: Properties of select fatty acids ................................ ................................ ........... 53 Table 11: Industrial soy

bean products 2009 ................................ ................................ ...... 56 Table 12: World soy

bean products 2009 ................................ ................................ ........... 57 Table 13: Summary

of i ssues of potential impacts and consequences of alternatives ....... 62 Table 14: Comparison of fatty acid profiles for oil derived from MON 87769 soy bean with several other oil sources ................................ ................................ .............. 75 Table 15: Comparison of percentage fatty acid in MON 87769 soy

bean with conv entinal control (A3535) and commercial range ................................ .......... 84 Table 16: U.S. vegetable oil prices ................................ ................................ .................. 109

**LIST OF FIGURES** Figure 1: Pathway s for the sy nthesis of EPA and DHA from Linoleic and alpha Linolenic Acid ................................ ................................ ................................ ...... 4 Figure 2 : Fatty

acid biosy

nthesis in plants and the introduced changes in MON 87769 soy bean ................................ ................................ ................................ ................. 5viii

**ACRONYMS AND ABBREVI ATIONS**  **AIA** a dvanced informed agreement **ALA** alpha - linolenic acid **ALS** Acetolactate Sy nthase **AOSCA** A ssociation of O fficial Seed Certifying Agencies APHI S Animal and Plant Health Inspection Service **BRS** Biotechnology Regulatory

Services (within USDA

–APHI S) **Bt** Bacillus thuringiensis protein **CAA** Clean Air Act **CBD** Convention on Biological Diversity **CFR** Code of Federal Regulations (United States) **CH 4**  m ethane **CLSS** closed loop stewardship sy stem **CO** c arbon monoxide **CO 2**  c arbon dioxide **CT** conservation tillage **DNA** deox yribonucleic acid **DHA** docosahexaenoic acid **EA** e nvironmental a ssessment **E. coli** Escherichia coli **ECOS** Environmental Conservation Online System (US FWS) **EIS** e nvironmental i mpact s tatement **EO** Executive O rder **EPA** eicosapentaenoic acid **EPSPS** 5 - enolpy ruvylshikimate - 3 - phosphate s ynthase **ESA** Endangered Species Act of 1973 **EU** European Union **FDA** U.S. Food and Drug Administration **FFDCA** Federal Food, Drug, and Cosmetic Act **FFP** f

ood, feed, or processing **FI FRA**  Federal Insecticide, Fungicide , and Rodenticide Act **FR** Federal Registerix

**g/kg** grams per kilogram **GE** g eneticall y e ngineered **GHG** greenhouse gas **GLA** gamma - linolenic acid **GMO** g eneticall y modified organism **GRAS** generall y recognized as safe **HDL** high - density lipoprotein **IP** Id entity

P reservation **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**  n itrogen dioxide **N 2**  **O** n itrous 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**  ozonex

**OECD** Organization for Economic Cooperation and Development **PI Ps**  plant incorporated protectants **Pj.D6D** Primula juliae ∆6 desaturase gene **PM 2.5**  particulate matter with an aerodynamic diameter less than or equal to 2.5

micrometers **PM 10**  particulate matter with an aerodynamic diameter less than or equal to 10

micrometers **POEA** p olyethox yl ated 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 soy beans **TES** threatened and endangered species **TSCA** Toxic Substances Control Act **U.S.** United States **U S**  **C** United States Code **USDA** U.S. Department of Agriculture **USDA -** **AMS** U.S. Department of Agriculture - American marketing Service **USDA -**  **ERS** U.S. Department of Agriculture - Economic Research Service **USDA -**  **NASS** U.S. Department of Agriculture -National Agricultural Statistics Service **U.S. EPA** U.S. Environmental Protection Agency **USFWS** U.S. Fish and Wildlife Services **VOC** volatile organic compound **WPS** Worker Protection Standard for Agricultural Pesticides **μm** micrometers **°F** degrees Fahrenheit1

**1 PURPOSE AND NEED**  **1.1 Regulatory Authority**  "Protecting American agriculture" is the basic charge of the United States Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS). APHI S provides leadership in ensuring the health and care of plants and animals. The agency improves agricultural productivity

and competitiveness, and contributes to the national econom y and the public health. USDA asserts that all methods of agricultural production (non - GE, organic, or the use of genetically

engineered varieties) can provide benefits to the environment , consumers, and farm income. Since 1986, the Un ited States (U.S.) government has regulated geneticall y engineered (GE) organisms pursuant to a regulatory framework known as the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) (51 FR 23302, 57 FR 22984). The Coordinated Framework, published by the Office of Science and Technology Policy , describes the comprehensive federal regulatory policy for ensuring the safety of biotechnology research and products and explains how federal agencies will use existing Federal statutes i n a manner to ensure public health and environmental safety while maintaining regulatory flexibility to avoid impeding the growth of the biotechnology industry . The Coordinated Framework is based on several important guiding principles: (1) agencies shoul d define those transgenic organisms subject to review to the extent permitted by their respective statutory authorities; (2) agencies are required to focus on the characteristics and risks of the biotechnology product, not the process by which it is create d; (3) agencies are mandated to exercise oversight of GE organisms only when there is evidence of “unreasonable” risk. The Coordinated Framework explains the regulatory roles and authorities for the three major agencies involved in regulating GE organisms : USDA’s Animal and Plant Health Inspection Service (APHI S), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency

( U.S. EPA). APHI S is responsible for regulating GE organisms and plants under the plant pest provision i n 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 feeds, including those that are geneticall y engineered. To help developers of food and feed derived from GE crops compl y with their obligations under Federal food safety laws, FDA encourages them to participate in a voluntary consultation process. All food and feed derived from GE crops currentl y on the market in the United S tates have successfull y complet ed this consultation process. The FDA policy statement concernin g regulation of products derived from new plant varieties, including those genetically engineered, was published in the Federal Register (FR) on May

29, 1992 (57 FR 22984 - 23005). Under this policy , FDA uses what is termed a consultation process to ensure that human food and animal feed safety issues or other regulatory

issues (e.g., labeling) are resolved prior to commercial distribution of bioengineered food.2

The U.S. EPA regulates plant - incorporated protectants (PIPs ) under the Federal Insecticide, Fungi cide, and Rodenticide Act (FIFRA) . U.S. EPA also sets tolerance limits for residues of pesticides on and in food and animal feed, or establishes an exemption from the requirement for a tolerance, under the Federal Food, Drug and Cosmetic Act (FFDCA) and regulates certain biological control organisms under the Toxic Substances Control Act (TSCA). The U.S. EPA is responsible for regulating the sale, distribution and use of pesticides, including pesticides that are produced b y an organism through techniques o f modern biotechnology . Because the genes expressed in MON 87769 are not pesticidal, they are not subject to these EPA regulations. **1.2 Regulated Organisms**  The APHI S Biotechnology Regulatory

Service’s (BRS) mission is to protect America’s agriculture and envi ronment using a dyn amic and science - based regulatory framework that allows for the safe development and use of GE organisms. APHIS regulations at 7 Code of Federal Regulations (CFR) part 340, which were promulgated pursuant to authority granted by the Plant Protection Act, as amended (7 United States Code (U.S.C.) 7701

–7772), regulate the introduction (importation, interstate movement, or release into the environment) of certain GE organisms and products. A GE organism is no longer subject to the plant pest provisions of the Plant Protection Act or to the regulatory requirements of 7 CFR part 340 when APHI S determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated article if the donor organism, recipient organism, vector, or vector agent used in engineering the organism belongs to one of the taxa listed in the regulation (7 CFR 340.2) and is also considered a plant pest. A GE organism is also regulated under part 340 when APHI S has reason to believe that the GE organism may be a plant pest or APHIS does not have information to determine if the GE organism is unlikely to pose a plant pest risk. A person may

petition the agency

that a particular regulated article is unlikely to pose a plant pest risk, and, therefore, is no longer regulated under the plant pest provisions of the Plant Protection Act or the regulations at 7 CFR 340. Under § 340.6(c)(4) , the petitioner is required to provide information related to plant pest risk that the agency may use to determine whether the regulated article is unlikely to present a greater plant pest risk than the unmodified organism. A GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act when APHI S det ermines that it is unlikely to pose a plant pest risk. **1.3 Petition for Determination of Nonregulated Status: MON 87769 Soybean**  Monsanto Company of St. L ouis, MO (Monsanto) , submitted a petition (APHI S Number 09 - 183 - 01p) to APHI S in 2009 seeking a determinatio n of nonregulated status for Event MON 87769 soy bean that is engineered to express high levels of the fatty acid stearidonic acid (SDA) in soy bean seed. As detailed in the petition, smaller amounts of three other fatty acids are produced in addition to th e SDA , and expression of linoleic acid is reduced ( Monsanto, 2010b ) . In the event of a determination of nonregulated status, the nonregulated status for MON 87769 soy bean would include MON 87769 soy bean , any progeny derived from crosses between MON 8 7769 soy bean and conventional soy bean, and crosses of MON 87769 soy bean with other biotechnology- derived soy bean that have been determined to be no longer subject to the3

requirements of Part 340 or the plant pest provisions of the Plant Protection Act. MON 87769 soy bean is currently regulated under 7 CFR part 340. Interstate movements and field trials of MON 87769 soy bean have been conducted under permits issued or notifications acknowledged b y APHIS from 2003 through 2008. Data resulting from these field trials are described in the petition ( Monsanto, 2010b ) . Notifications acknowledged and permits issued by

APHI S are listed in the petition ( Monsanto, 2010b ) . The test sites represent diverse regions of the U . S ., including the major growing areas of the Midwest (W isconsin , M ichigan , M innesota M issouri , I owa , I llinois , Indiana, Kansas, Kentucky, Nebraska, South Dakota, Pennsylvania, Ohio, and Arkansas), and winter nurseries in Puerto Rico and Hawaii. Field tests conducted under APHI S oversight allow for evaluation in agricultural settings under confinement measures designed to minimize the likelihood of persistence in the environment after completion of the field trial. Under confined field trial conditions, data are gathered on multiple parameters and used b y applicants to evaluate a gronomic characteristics and product performance. These data are also valuable to APHI S for assessing the potential for a new variety to pose a plant pest risk. The data evaluated for MON 87769 soy bean may be found in the APHI S Plant Pest Risk Assessment ( PPRA) (USDA - APHIS, 2010c ) . **1.4 Purpose of Product**  Monsanto seeks a determination of nonregulated status of MON 87769 so ybean , a specialty trait soy bean characterized by a fatty acid profile containing SDA, an omega - 3 fatty acid, which is not found in conventional soy bean. 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 ph ys iologicall y healthful conditions. These fatty acids may commonly

be derived from fish oils, but a soy

bean 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 soy bean oil is more stable to oxidation (i.e., less prone to fish y or rancid odors and taste) than fish oils, thereb y expanding the potential formulation options for food companies and food products for consumers. The biosy nthetic pathway s for interconversions of the linoleic, linolenic and SDA to EPA and DHA are shown in Figure 1. SDA production in MON 87769 soy bean is accomplished by

inserting two desaturase genes, Primula juliae Δ6 desaturase ( Pj.D6D) and Neurospora crassa Δ15 desaturase ( Nc .Fad3) , into a conventional soy

bean variety . The Pj ∆6D and Nc∆15D proteins found in MON 87769 soy bean also produce gamma - linolenic acid (GLA), another fatty acid not in conventional soy bean. In MON 87769, the Nc Δ 15D protein converts linoleic 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, 2010b) . Figure 2 shows the existing pathway s by which desaturases form fatty acids in conventional soy

beans and how the pathway s are altered when the two desaturase genes, Primula juliae Δ6 desaturase ( Pj.D6D) and Neurospora crassa Δ15 desaturase ( Nc.Fad3) inserted into MON 87769 soy bean form fatty

acids.4 Source: Source:

( Council for Responsible Nutrition, 200 5 ) . **Figure 1. Pathways for the synthesis of EPA and DHA from Linoleic and alpha** **- Linolenic** 

**Acid.** MON 87769 soy

bean would not be grown for the commodity soy bean market; instead, it is anticipated that a specialty soy bean oil from MON 87769 soy bean would be produced. Compared to commodity soy bean oil, SDA soy

bean oil contains two additional fatty acids, SDA and GLA. SDA omega - 3 soy bean oil produced from MON 87769 soy bean contains approximately

20 to 30% SDA (weight percent of total fatty acids), 5 to 8% ga mma - linolenic acid (GLA), and slightly

higher levels of alpha - linolenic acid (ALA) and palmitic acid than in conventional soy

bean oil ( Monsanto, 2010b ) . It also contains lower levels of oleic acid and linoleic acid (LA) than those present in conventional soy bean oil. Since oleic acid, linoleic acid, and alpha - linolenic acid are directl y involved in the pathway to SDA, their concentrations are inter - related with th ose of other fatty acids and, therefore, were expected to be different in MON 87769 soy

bean seed.5

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

**soybean** SDA omega - 3 soy

bean oil produced from MON 87769 soy bean can be included in a range of food products for health benefits. The use of SDA soy bean oil in selected food categories could provide a wide range of dietary alternatives for increasing human omega - 3 fatty acid intake. SDA soy bean oil is intended for use in a variety of food products including baked goods and baking mixes, breakfast cereals and grains, cheeses, dairy product analogs, fats and oils, fish products, frozen dairy

desserts and mixes, grai n products and pastas, gravies and sauces, meat products, milk products, nuts and nut products, poultry products, processed fruit juices, processed vegetable products, puddings and fillings, snack foods, soft candy , and soups and soup mixes at levels that will provide 375 milligrams ( mg) SDA per serving. Fish and plant oils rich in omega - 3 fatty acids also are used in feed applications such as aquaculture and poultry feeds. SDA soy bean oil from MON 87769 soy bean may eventuall y be used in aquaculture and fe ed applications as an alternative to fish oil and other omega - 3 rich feed components. It is anticipated that MON 87769 soy bean will have low production acreage (< 5% of total U.S. soy bean acreage or up to 3 to 3.5 million acres) in North America. In order to derive commercial value from this product, the SDA soy bean crop will be grown a closed - loop production and marketing s ys tem in the soy bean growing region of th e Northern U.S ( Monsanto, 2010b ) . **1.5 APHIS Response to Petition for Nonregulated Status**  Under the authority

of the plant pest provisions of the Plant Protection Act and 7 CFR part 340, APHI S has issued regulations for the safe development and use of GE organisms. As requ ired by 7 CFR 340.6, APHIS must respond to petitioners that request a determination of the regulated status of geneticall y engineered organisms, including GE plants such as MON 87769 soy bean . When a petition for nonregulated status is submitted, APHI S must make a determination if the geneticall y engineered organism is unlikely to pose a plant pest risk. If APHI S determines based on its PPRA that the genetically engineered organism is unlikely to pose a plant pest risk, the geneticall y engineered organism i s no longer subject the plant pest provisions of the Plant Protection Act and 7 CFR part 340. 18:0 stea ric a cid 18:1

oleic a cid Δ9 18:3 α - lin o l enic acid Δ12 2

18:3 γ - linolenic a cid 18:2

lino l eic Δ15

2

18:4 stearidonic acid Δ6 Δ6

Δ15 Pathways where soybean’s existing desaturases form fatty acid Pathways where desaturases introduced in MON 87769 form fatty acids6

APHI S has prepared this environmental assessment (EA) to consider the potential environmental effects of an agency

determination of nonregulated status consistent with Council of Environmental Quality ’s National Environmental Policy Act (NEPA ) regulations and the USDA and APHI S 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 ord er to specifically evaluate the effects on the quality

of the human environment 1 that may result from a determination of nonregulated status of MON 87769 soy bean . **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 soy bean does not express a pesticidal property , and , accordingl y , is not regulated by the U.S. EPA. 1.6.2 Food and Drug Administration FDA regulates GE organisms under the authority of the FFDCA (21 U.S.C. 301 et seq. ). The FDA published its policy statement concerning regulation of products derived from new plant varieties, including those that are GE, in the Federal Register on May 29, 1992 (57 FR 22984). Under this policy , FDA implements a voluntary consultation process to ensure that human food and animal feed safety

issues or other regulatory issues, such as labeling, are resolved before commercial distribution of bioengineered food. MON 87769 soy

bean is within the scope of the FDA policy statement concerning regulation of products derived from new plant varieties, including those produced through genetic engineering. Monsanto initiated the consultation process with FDA for the commercial distribution of MON 87769 soy bean and submitted a safety and nutritional assessment of food and feed derived from MON 87769 soy bean to the FDA on March 23, 2009 (BNF No. 00117) ( Monsanto, 2010b ) . FDA is currentl y evaluating the submission. FDA also administers the Generally Recognized as Safe (GRAS) Notification Program (US FDA, 2011 ) . A substance that will be added to food is subject to premarket approval b y FDA unless qualified experts determine its use is generally recognized as safe (GRAS). Un der the GRAS program (62 FR 18938), a notification procedure is established whereby FDA is notified by a person that they

have made a determination that a particular use of a substance is GRAS. FDA evaluates the submission to determine whether a sufficient basis for a GRAS determination has been provided or issues exist on whether use of the substance is GRAS. Monsanto submitted a GRAS Notice for SDA soy bean oil (No. GRN 000283) to FDA on February 25, 2009 (US FDA, 2009b ) . FDA issued a response letter on September 4, 2009, indicating the agency has no further questions about the characteristics of the oil, and the safety of its use in foods (US - FDA, 2009a) . 1 Under NEPA regulations, the “human environment” includes “the natural and physical environment and the relationship of people with that environment” (40 CFR §1508.14).7

**1.7 Public Involvement**  APHI S routinel y seeks public comment on draft EAs prepared in response to petiti ons for nonregulated status of GE organisms. APHI S does this through a notice published in the Federal Register . The issues discussed in this EA were developed by considering the public concerns as well as issues raised in public comments submitted for other EAs of GE organisms, concerns raised in lawsuits, as well as those issues of concern that have been raised by various stakeholders. These issues, including those regarding the agricultural production of soy beans using various production methods and th e environmental and food/feed safety of GE plants were addressed to anal yz e the potential environmental impacts of MON 87769 soy bean . This EA, the petition submitted by Monsanto , and APHI S’s PPRA will be available for public comment for a period of 60 day s (7 CFR § 340.6(d)(2)). Comments received by the end of the 60 - day period will be analy

zed and used to inform APHI S’ determination decision of the regulated status of MON 87769 soy bean and to assist APHI S in determining whether an Environmental Impact Statement (EIS) is required prior to the determination decision of the regulated status of this soy bean variety . **1.8 Issues Considered**  The list of resource areas considered in this draft EA wer e developed b y APHI S through experience in considering public concerns and issues raised in public comments submitted for other EAs of GE organisms. The resource areas considered also address concerns raised in previous and unrelated lawsuits, as well as issues that have been raised b y various stakeholders in the past. The resource areas considered in this EA can be categorized as follows: Agricultural Production Considerations:  Acreage and Areas of Soy bean Production  Agronomic/Cropping Practices  Soy bean Seed Production  Organic Soy

bean Production  Specialty

Soy bean Production Environmental Considerations:  Water Resources  Soil and L and Use  Air Quality  Climate Change  Animals  Plants  Gene Flow  Microorganisms  Biological Diversity Human Health Considerations:8

 Public Health  Worker Safety Livestock Health Considerations:  Livestock Health/Animal Feed Socioeconomic Considerations:  Domestic Economic Environment o Implications for Food Use o Implications for Industrial Use  Trade Economic Environment  Social Environment9

**2 AFFECTED ENVIRONMENT**  The Affected Environment s ection provides an overview of the use and composition of soy bean s , followed b y a discussion of the current conditions of those aspects of the human environment potentially

impacted b y a determin ation of nonregulated status of MON 87769 soy bean . For the purposes of this draft EA, those aspects of the human environment are: soybean production practices, the ph ys ical environment, biological resources, human health, animal feed, and socioeconomic is sues. Because production of MON 87769 soy bean is expected to be limited by actions taken b y Monsanto , the affected environment assessed in this EA will primarily focus on th ose geographical areas where MON 87769 soy bean would potentiall y be planted. As i ndicated by Monsanto, the area to which production will be limited includes the Northern Tier states of North and South Dakota, Minnesota, Wisconsin , and Michigan ( Monsanto, 2010c ) and a combination of geographically delimited seed sales, released maturity groups and soy

bean purchases, and contracts will provide a means to define the production area . **2.1 Soybean**  **Products and Composition** The soy bean is an economically

important leguminous crop providing oil and protein. Soy bean plants are grown for their seed, which is further processed to yi eld oil for a variety of uses and meal for livestock feed and human dietary products. Soy

bean uses in the U.S. include edible soy bean oil, soy- based biodiesel, animal feed, tofu, and industrial chemicals ( Soy Stats, 2010a) . This subsection provides an overview of the various uses and associated composition of soy bean. 2.1.1 Soy

b ean Use Approximately

50% of the world soy

bean seed supply

in 2009 was crushed to produce soy bean 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 soy bean protein products . Another 34% of the world so ybean seed supply was traded to other geographies, with China, the European Union (EU), Japan, and Mexico being the top soy bean seed importers ( Soy Stats, 2010h) . The remainder of the soy bean seed produced was used as certified seed, feed, or stocks. Industrial uses of so ybean range from a carbo n/nitrogen source in the production of yeasts via fermentation to the manufacture of soaps, inks, paints, disinfectants, and biodiesel (see, e.g., ( Cahoon, 2003 ) ; ( Soy Stats, 2010a) ). Soy bean oil generall y has a smaller contrib ution to soy bean’s overall value compared to so ybean meal because the oil constitutes just 18 to 19% of the soy bean's weight. Nonetheless, soy bean oil accounted for approximately 30% of all the vegetable oils consumed globally and was the second largest s ource of vegetable oil worldwide, slightly behind palm oil representing approximately

32% of global consumption (Soyatech, 2010). Soy bean oil also has industrial applications, including feedstock in manufacture of inks, paints, varnishes, resins, plastics , and biodiesel ( ( Cahoon, 2003 ) ; ( Soy Stats, 2010a) ) . Soy bean meal is used as a supplement in feed rations for livestock. Soybean meal is the world's most important protein feed, accounting for nearl y 69% of world protein meal supplies ( Soy Stats, 2010f ) . Soy bean is grown as a commercial crop in more than 40 countries (those with greater than 10,000 hectares) ( FAO, 2010 ) . Processed so yb eans supply the largest worl d source of protein10

animal feed and the second largest source of vegetable oil (USDA - ERS, 2010e ) . U.S. total oilseed production consists of more than 90% b y weight of soy beans while the remainder is other oilseeds

— such as cottonseed, sunflower seed, canola, and peanuts ( USDA - ERS, 2010e ) . Soy bean Meal Following solvent extraction of th e oil, the remaining solid soybean flakes are toasted and ground to produce so yb ean meal ( Soyatech, 2008 ) . Soy bean seed (at 13% moisture) with about 18% oil will contain 34.6 to 36.7% protein, and the derived so yb ean meal will contain 47.5 to 48.8 % protein b y dry weight ( Brumm and Hurburgh Jr, 2006 ) . Onl y a small proportion (1%) of the soy bean is consumed directly by humans as protein; most domestic soy bean meal is used b y the American livestock industry ( USB, 2011a ) . The mixed rations for poultry , hogs, cattle, dairy cows, domestic pets, and farmed fish often a re formulated with soy

bean meal. In 2010, poultry were the largest consumers of soy bean meal (49%), followed by hogs (25%) and then cattle (12%) ( Soy stats, 2011a) . Other animal consumers include farmed fish and domestic pets. Soy bean Oil S oy bean oil is used in a wide variety of food applications. Until 2005, soybean oil was the largest source of vegetable oil worldwide (USDA - ERS, 2010e ) . Since 2005, palm oil has overtaken so yb ean oil in volume of worldwide vegetable oil production (USDA - ERS, 2010e ) . Conventional soy

bean oil is composed of a mixture of fatty acids. Fatty acids are identified based on the number of carbons and the degree to which they are saturated. Table 1 presents the fatty acid composition of soy

bean. The five major fatty acids in conventional soybean oil are linoleic acid, oleic acid, palmitic acid, linolenic acid, and stearic acid ( CODEX, 2010 ) . L inoleic and linolenic are classified as poly unsaturated fatty acids, oleic acid is a monounsaturated fatty acid, and palmitic and stearic acids are saturated fatty acids ( CODEX, 2010 ) . The phy sical and chemical properties of conventional soy bean oil lim it its use for many food and industrial applications ( Cahoon, 2003 ) . As noted in Table 1, untreated soy bean oil has high concentrations of the linolenic and linoleic acids, both poly unsaturated fatty acids (US - FDA, 1996 ) . These pol yunsaturated 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 h ydrogenation has been used to decrease the percentage of pol yunsaturated fatty acids in the soy oil blend (US - FDA, 1996 ) . The selective hydrogenation dramatically improves shelf life and provides stability during deep - frying and other high temperature applications ( Mozzaffarian et al., 2006 ) . Although the h ydrogenation process does increase the percentage of monounsaturated oleic acids, the hydrogenation process produces substantial quantities of the trans isomer of oleic acid. Such trans - fats have been identified as negatively impacting human cholesterol levels b y raising the low - density lipoprotein (LDL) cholesterol and lowering the high - density lipoprotein (HDL) cholesterol. This association with trans - fatty acids has resulted in a decline in so ybean oil consumption in the U.S. (USDA - ERS, 2006a) .11

**Table 1 .**  **Fatty a**  **cid c**  **omposition of c**  **onventional s**  **oybean o**  **il .**  **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: *F atty acids are identified based on the number of carbon atoms and the numb er 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 atom s with a single double bond. ND

– Not detectable Soy bean Food Products Soy bean is used in various food products, including tofu, so ybean sauce, soy milk, energy

bars, and meat products. A significant fraction of the soybean market is dedicated to production of purified oil for food use and industrial applications ( Cahoon, 2003 ) . Food uses include margarines, shortenings, and cooking and salad oils ( OECD, 2000 ) .12

2.1.2 Soy

bean Composition Generally , soy

bean seed consists of oil (about 20%), protein (about 40%), carbohydrate (about 35%), and ash (about 5%) ( Liu, 1997 ) Various constituents have importance to the health and nutrition value of soy

bean, such as the isoflavonoids. Others are anti - nutritive, and many of these can be eliminated by the routine heati ng of the protein or meal fraction during processing for animals or humans. The oil fraction is composed of triglycerides with associated fatty acids, whose profile has significant consequences for human health and nutrition. The protein fraction is the most valued part of the soy bean, and represents a complete protein that is important in human diets and feeding of livestock, poultry and farmed fish. The carbohydrate fraction of soy bean flours can include both nutritive sugars (glucose, sucrose, galactos e and others) and those that cannot be processed b y human digestive enzymes (raffinose, stachyose) (see ( Eldridge et al., 1979 ) ) . Protein Soy bean is considered to be a source of complete protein. A complete protein is one that contains significant amounts of all the essential amino acids that must be provided to the human body because of the body’s inability to sy nthesize them. The ten essential amino acids are arginine, histidine, isoleucine, leucine, l ys ine, methionine, phenylalanine, threonine, try ptophan, and val ine ( Kuiken and Ly man, 1949 ) . Soy

bean provides these ten essential amino acids necessary for human nutrition, which is in addition to another 10 which can by s ynthesized b y human metabolism from other nitrogen containing precursors ( Kuiken and Ly man, 1949 ) . The essential amino acid c omposition of soy bean and soy- based products is provided in the USDA National Nutrient Database for Standard Reference (USDA - ARS, 2008b ) . Isoflavones Soy beans contain isoflavone compounds, poly p henol compounds closely related to the antioxidant flavonoids found in other plants ( Manach et al., 2004 ) . Soy bean isoflavones are described as ph yt oestrogens because they exhibit e strogenic activity similar to estradiol hormones ( Rostagno, 2009 ) . These isoflavones may provide both benefits and negative impacts, as they are variousl y reported to exhibit estrogenic and anti - estrogenic effects, influence cardiovascular disease, impact cancer rates, and possibly slow the rates of osteoporosis. The majo r soy bean isoflavones include genistein and daidzein. I soflavones are produced primarily by beans and other legumes such as peanuts and chickpeas. (See Higdon and Drake ( Higdon and Drake, 2009 ) for a summary of recent research on soy isoflavones.) The negative impacts of isoflavones are those that have been shown to have some adverse consequences to pest insects that feed on them, such as feeding inhibition for larvae of the moth Spodoptera litura among others ( Zhou et al., 2011 ) . Antinutrients Antinutrients are components of a food product which may be toxic at high concentrations, bind nutrients, or otherwise prevent their digestion. Soybeans contain several key antinutrients, such as oligosaccharides, lectins, phy tic acid, and protease inhibitors ( OECD, 2001 ) . Protease inhibitors include try

psin and chy

motry psins ( OECD, 2001 ) . Lectins are sugar - binding protein13

inhibitors. The activity

of these inhibitors is destroyed during the h eat processing of so ybean products. The carboh ydrates stach yose and raffinose which are oligosaccharides can cause flatulence when consumed ( Rackis, 1974 ) . Phy tic aci d binds most of the phosphorus in soy bean, preventing its absorption by an animal. It is common practice to add phy tic acid - degrading enzy mes to the animal feed formula ( Monsanto, 2010b ) . Protease inhibitors interfere with the digestion of proteins, resulting in decreased animal growth ( OECD, 2001 ) . The antinutrients are destroyed during the heat treatment processing of the soy bean products ( OECD, 2001 ) . Fatty Acids Saturated fatty acids in soybean include palmitic and stearic; whereas palmitic acid raises total cholesterol and low density lipoprotein (associated with adverse cardiovascular events) stearic does not (see review in ( Micha and Mozaffarian, 2010 ) ). Poly unsaturated fatty

acids in soy

bean include linoleic and linolenic, and the monounsaturated fat is oleic. Evidence from the best human studies show that when poly unsaturated fatty

acids replace saturated ones in the diet, the risk of cardiovascular heart disease declines (but not when caloric replacement is carbohydrate) ( Micha and Mozaffarian, 2 010 ) . When monounsaturated fatty acids (e.g., oleic acid) replace saturated fatty

acids, effects are uncertain because of mixed evidence at present ( Micha and Mozaffarian, 2010 ) . Trans - fats in the diet are unhealthy ; these are produced when soy bean fatty acids such as linolenic and linoleic are subjected to hydrogenation because of inherent low stability, or because properties of soy bean oils are unsuitable for certain food uses. In corporation of consequent trans - fats in foods results in known undesirable effects on blood lipid parameters (lowering HDL s, increasing trigl ycerides, and increasing LDL s). In turn, these measured parameters of human health correlate with adverse effects on cardiovascular health (see review in ( Micha and Mozaffarian, 2008 ) ). **2.2 Agricultural Production of Soybean**  Soy bean ( Glycine max (L.) Merr.) plants are grown for their seed, which is further processed to yi eld oil and meal. In the U.S., the majority of soybean is cultivated as a commodity crop for animal feed and so ybean meal ( Monsanto, 2010b ) . Soy bean is ranked number one in oil production (5 8 percent) among the major oil seed crops production in the world (ASA, 2011 ) . Recently , there has been an increase in the percentage of the crop dedicated to specialty soy bean produced for a specific market or use. These specialty , value - added products may be the whole bean or a fraction, such as the oil ( Le e and Herbek, 2004 ) . The production of specialty so ybean is discussed in more detail in Subsection 2.2.5. 2.2.1 Acreage and Area of So ybean Production Soy bean production in the U . S . extends over a wide range of geographies and regions , and is grown from North Dakota to L ouisiana and from the Great Plains s tates to the Eastern Seaboard (USDA -NASS, 1997 ) . In the U . S . , soy beans were harvested on 76.4 million acres in 2009 and 76.6 million in 2010 (USDA -NASS, 2011a) . At least 31 states grew soy bean as an annual crop in 20 10 (USDA -NASS, 2011a) . For the 2010 growing season, more than one million acres of soy beans were grown in each of the following 18 states (from hi ghest to lowest acreage): Iowa, Illinois, Minnesota, Indiana, Missouri, Nebraska, Ohio, Kansas, South Dakota, North Dakota, Arkansas, Michigan, Mississippi, Wisconsin, North Carolina, Tennessee, Kentucky , and14

Louisiana (USDA -NASS, 2011a) . Harvested s oy bean is projected to slightly increase to nearl y 80 million acres by

2020 (USDA -NASS, 2011b ; USDA - OCE, 2012 ) . Although so ybean acreage has increased from 2005 to 2010 by about 7% ( USDA -NASS, 2011a) , the potential for an increase into uncultivated acreage is low because soy bean is profitably grown on high quality agricultural land, not lands of lower productivity ( EIA, 2007 ; USDA -NASS, 2011a) . Much of the high quality land in the U.S. is already committed to agricultural production ( US - EPA, 2007 ) and in 2002, USDA - Economic Research Service (USDA - ERS) estimated that only 2.1% of cropland was idle in 2002 ( Lubowski et al., 2006 ) . At the same time , U . S . crop and agricultural acreage is declinin g through replacement b y urban and other developed areas ( EIA, 2007 ) . It is unlikely that “new” previousl y uncultivated land will be brought into so ybean production, but rather that growth of soy bean production will compete with other agricultural uses ( EIA, 2007 ) . Geneticall y modified plants, including soybeans, have been widel y planted, with increasing frequency after their commercial introduction in the late 1990s. GE so ybeans currently are planted on the majority

of soy bean acres in the U.S. (93% of acreage in 2010) (USDA - ERS, 2011a) . All these GE soy bean varieties are herbicide resistant. Besi des genetically modified soy bean varieties with crop production traits, such as herbicide tolerance, varieties expressing altered fatty

acids are also available to growers (e.g., low linolenic varieties, see Specialty Soy bean Production, Soybean Varieties with Altered Fatty Acids in Section 2.2.5 and ( Fehr, 2007 ) ) . At present, these fatty acid modified lines are non - transgenic products, but new GE varieties are being developed ( Cahoon, 2003 ) . Monsanto plans to channel production of SDA soy bean into a limited region using several strategies identified below ( Monsanto, 2010c ) . Constraints on productio n areas will be imposed by the seed provider (see first bullet below) and , to some extent, also by the biology of the specialty crop (see third bullet) . Several measures are currentl y used in the production of specialty soy beans, including contracts specifying details of production and sales between growers and soy

bean purchasers (see second bullet). These measures will be used by Monsanto to limit the production area of MON 87769 so yb ean:  The relative maturity

groups (MG) in which the developer rel eases the traits. Growers must use varieties which are best adapted to the local season. Day length, temperature and length of the growing season may affect the time of flowering and seed formation ( Setiyono et al., 2007 ) and so ybean maturity is affected b y the local day length ( Cober et al., 1996 ) . Thus, soy bean yield , and therefore, commercial value, is a consequence of the MG and planting location.  The area in which designated elevators and specialty oil crushers are located. Soy bean growers will sign contracts with elevators and processors which will be designated in advance b y the trait developer. These businesses would have compartmented storage available f

or specialty oilseed crops, and would agree to conditions specified in Monsanto’s management plan, which would be required for segregating the crop. If soy bean buyers are located too distant from production sites, cost of transport increases and profits d ecline; economic penalties further constrain so yb ean movement.  The environment in which the soy beans are grown determines desired properties of the soy beans . Monsanto has determined that states located in the northern U . S . provide the15

optimal environment for maximal expression of SDA from MON 87769 soy bean ( Monsanto, 2010b ) . Through these means, Monsanto will be able to limit where growers produce MON 87769 soy bean which will be the states of North and South Dakota, Minnesota, Wisconsin , and Michigan ( Monsanto, 2010c ) . Some of the largest soy bean production areas, such as I llinois , I owa , Indiana and M issouri, would not be inc luded 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 characterize d as lowland, level with some hills, and with fertile soils ( McKnight, 2004 ) . Corn, soy bean, alfalfa, hay , fruit, beef cattle, hogs and dairy cattle are produced here. The other area where Monsanto plans to target production of MON 87769 soy bean is the eastern - most fringes of the Great Plains and prairies **,** which includes parts of North and South Dakota. These lands are characterized as flat or sloping land ( McKnight, 2004 ) . Wheat, but also corn, soybean, sorghum, canola, sunflower, edible beans and peas, barley and rye, flaxseed, oats and sugar beets are grown here; cattle may be produced in this region ; areas that are under irrigation allow vegetable and fruit production for cities (truck crop s) . These areas targeted b y Monsanto for MON 87769 soy bean production are areas where considerable commodity

soy bean is already

p roduced (Tables 2 and 3).16

**Table 2**  **. U.S. s**  **oybean p**  **roduction in N**  **orthern T**  **ier s**  **tates in 2010 .**  **State Acres**  **H arvested** 

**(x 1000) Production** 

**(x 1,000 bushels) Yield (**  **bushels**

**per acre)**  Michigan 2,090 91,960 44 Minnesota 7,3 1 0 328,950 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 s**  **tates and the U .**  **S .**  **in 2007 along with other princip**  **al crops**  **. State**  **First Rank Crop Rank of Soybean**  **Crop in State Rank of State** 

**Soybean Production in U.S.**  Michigan Corn (for grain) 2 3 Minnesota Corn (for grain) 2 12 North Dakota Wheat (for grain) 2 9 South Dakota Corn (for grain) 4* 34 Wisconsin Corn (for grain) 3 15 Source: 2007 Census of Agriculture (USDA -NASS, 2009 ) Note: *Wheat, forage and soybean acreage nearly equal 2.2.2 Agronomic Practices In this EA, “c onventional farming ” includes any farming s ys tem where s ynthetic pesticides or fe rtilizers may

be used. Conventional farming covers a broad scope of farming practices, ranging from farmers who only occasionall y use synthetic pesticides and fertilizers to those farmers whose harvest depends on regular pesticide and fertilizer inputs. C onventional farming also includes the use of geneticall y engineere d (GE) varieties that are no longer subject to the regulatory

requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act. Soy bean self - pollinates and is propagated b y seed ( OECD, 2000 ) . Proper seedbed preparation, appropriate variety selection, appropriate planting dates and plant population, and good17

integrated pest management practices are important for optimizing the yield potential and economic returns of so yb ean ( Barrentine, 1989 ; USDA - APHI S, 2010b ) . Soy bean Maturity

Groups Soy bean varieties are developed and adapted to certain geographical zones (bands about 100 - 150 miles north to south) and are separated into ten maturity groups – Group 00 to Group VIII: Group 00 through Group IV soy bean varieties are planted in the Midwest and Eastern Coastal regions; Groups IV through VIII are planted in the southern states ( Helsel and Minor, 1993 ; Hodges and French, 1985 ; Pioneer, 2011 ) . To adapt to the local growing season, producers ty picall y plant seed of an appropriate maturity group so that its development and harvest coordinates with the seasonality of the location. To avoid frosts and maximize yield and oil content, the grower’s priority is to plant soy

bean as earl y as possible and to use the early maturing varieties (North Dakota) ( Berglund and Helms, 2003 ) . In the five Northern T ier states , the 0 - 2 maturity

groups would be generally planted ( Zhang et al., 2007 ) , but University of Wisconsin Extension (UW - Extension, 2008 ) has tested maturity groups between 0.1 and 2.8 in various parts of Wisconsin to match local conditions . In parts of Michigan, a maturity group as high as 3.4 might be planted ( MSU - Extension, 2010 ) and in parts of North Dakota 00 or even 000 might be planted ( Kandel, 20 08 ) . Pre - Season Preparation Crop rotation, tillage s ys tem, row spacing, planting equipment, seed or trait selection(s), herbicide choices and details of soil fertility require production decisions well in advance of planting the so ybean crop. Planting and Early

Season Adequate soil moisture and warm temperatures facilitate rapid seed germination and emergence. Planting date has the greatest impact on yield ( Hoeft et al., 2000 ) . Soy bean can germinate at a soil temperature of 50 degrees Fahrenheit ( oF ) when planted at a depth of two inches, with the ideal soil temperature for soy bean 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 so ybean planting activity begins in mid - May

(as earl y as the 10th in some states) and continues through earl y June , with Wisconsin planting as late as June 20 (USDA -NASS, 1997 ) . As an example, in Wisconsin, although the highest yield comes from planting before May 20, delayed planting to June 1 could reduce yield to an estimated 89 per cent and by June 10 to 75 percent (with a plant population of 200,000) ( Conley and Gaska, 2011 ) . Recommended herbicide use in Roundup Ready Soy bean (NDSU Weed Science ) :  Strategy

1: Pre - emergent herbicide or pre - plant incorporated metolochlor, pendimethalin, Fierce, or metribuzin, etc. used. Most require rain for activation.  Strategy

2: Gl yphosate applied to earl y emerged weeds.  Strat egy

3: Gl yphosate applied to 2 - 4 inch weeds.18

For tillage practices in early season, see Tillage section, below. Mid - to L ate Season Id eal day time temperatures for soy bean growth are between 75oF and 85oF ( Hoeft et al., 2000 ) . Warmer temperatures result in larger plants and earlier flowering. Sustained temperatures below 75oF will delay

the beginning of flowering significantly . Seed set also is affected by temperature. Seed set is generall y ideal when pollination follows night temperatures around 70oF. Soy

bean varietie s 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 soy bean plant does not form a pod for each flower. It is common for a soy bean plant to have 75% of its flowers fail to develop a pod ( Monsanto, 2010b ; Scott and Aldrich, 1970 ) . Recommended herbicide use in Roundup Ready Soy bean (NDSU Weed Science ) :  Strategy

1: Gl yphosate applied to soy bean post - emergent (follows earl y pre - emergent soil applied or - incorporated herbicide).  Strategy

2: Post emergent herbicide acetochlor, imazamox, bentazon/sethoxydim, acifluorifen (follows gl yphosate applied pre - emergent to soy bean).  Strategy

3: Roundup/glyphosate 14 - 21 day s after first application (follows gl yphosate applied to pre - emergent soy bean). 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 day s from physiological maturity ( Hoeft et al., 2000 ) . Soy

bean is harvested when the moisture content drops below 15%. From preharvest through combining, so ybean 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 S outh D akota , N orth D akota , M innesota , M ichigan , W isconsin between late S eptember (N orth D akota) and mid - to late - October (W isconsin : early

November) (USDA -NASS, 1997 ) . Recommended fall herbi cide use in Roundup Resistant Soy bean for next season soy

bean ( MSU, 2011 ) :  1: Burndown without residual activity : gly phosate, gramoxone, 2,4 - D. 2: Burndown with residual activity : Authority Assist, Canopy , Autumn, Extreme. Crop Rotation19

Soy bean crop rotation is an important management practice for managing weeds, to control volunteer so ybeans, and to limit the potential for weeds to develop resistance to herbicides (e.g., gl yphosate - resistant pigweed). According to USDA - ERS , 95% of the so ybean - planted acreage has been in some form of a crop rotation sy stem since 1991 (USDA - ERS, 2010c ) . The benefits of soy

bean rotation with, for example, corn are many and include:

• Improved yi eld and profitability of one or both crops;

• Decreased need for additional nitrogen on the crop following so ybean;

• In creased residue cover;

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

• Reduced soil erosion;

• In creased soil organic m atter;

• Improved soil tilth and soil phy sical properties; and

• Reduced runoff of nutrients, herbicides, and insecticides (Al - Kaisi et al., 2003 ) . Agronomic practices for soy bean rotations vary

from state to state. Continuous (i.e., non rotation) soy

bean production is discouraged by most extension soy

bean specialists to reduce the risk of diseases and nematodes (Al - Kaisi et al., 2003 ) . In a sur vey of major corn/soy

bean production states, corn and soy bean were alternated on 72 to 80% of acreage, other rotations were grown on 16 to 20 % of acreage, and so yb ean was grown continuously on 5 to 12% of acreage during the years 1996 - 2002 ( Sandretto and Pay ne, 2008 ) . In another anal ys is, the majority of the U.S. soy

bean acreage (68.6%) is rotated to corn ( ( Monsanto, 2010b ) at page 157, et seq.). Approximately

14.5% of the soy

bean acreage is rotated back to soy bean the following ye ar. Wheat follows soybean on approximately 11.2% of the U.S. soy

bean acreage, with cotton, rice, and sorghum the next largest rotational crops following so ybean (4.6% of the so ybean acreage). Other minor rotational crops that follow soy bean production include barley , rice, oats, and dry beans. In the Northern T ier states where MON 87769 soybean would likel y be grown, corn is often grown following so yb ean , but other crops may be added to the basic rotation, often small grains ( Table 4) (UW - Extension, 2004 ) . In e astern South Dakota, a corn - soy bean rotation when coupled with a wheat crop is advantageous, since it may reduce yi eld losses caused b y corn soy bean adapted Diabrotica species (corn rootworm), soy bean cy st nematode, and weeds that proliferate in so yb ean an d corn (Anderson, 2008 ) . In southwest ern Michigan, increasing crop diversity in crop rotations has been shown to increas e corn grain yi eld ( Smith et al., 2008 ) . Double cropping (i.e., plantings two crops in the same field within one ye ar) of so ybean with wheat is discouraged, since a predictable rate of return on late planted so yb ean cannot be established ( Conl ey

et al., 2008 ) .20

**Table 4**  **. First and s**  **econd m**  **ost f**  **requent r**  **otational c**  **rop f**  **ollowing s**  **oybean State**  **Rotational Crop**

**Following Soybean Percentage of** 

**rotational crop planted** Michigan Corn 70 Wheat 25 Minnesota Corn 76 Wheat 18 North Dakota Corn 30 Wheat 45 South Dakota Corn 72 Wheat 20 Wisconsin Corn 85 Alfalfa 4 Source: Table IX - 8, column G, based on personal communications with state extension specialists and Monsanto Technol ogy Development Representatives ( Monsanto, 2010b ) . Tillage Mechanical weed control by means of tillage is an important aspect of soy bean cultivation, and in 2006, no - till production ranged from 9.2 to 47.7% of so ybean production in the five Northern T ier states in 2006 ( Horowitz et al., 2010 ) . Other ty pes of conservation tillage, reduced and conventional till age, made up the remainder . Conservation tillage practices have seen increased use throughout the U . S . in recent ye ars, especially in the Midwest where wind and water erosion are often import ant 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 Pay ne, 2008 ) . Soy bean tillage has been summarized in five categories, with two groups, one of “conservation tillage” (no - till, ridge - till and mulch - till) or “other tillage practices” (reduced till and intensive till) ( CTI C, 2010b ) . Conventional tillage is associated with intensive plowing and less than 15 percent crop residue; reduced tillage is associated with 15 to 30 percent crop residue; and conservation tillage, including no - till practices requiring herbicide application on the plant residue from the previous season, is associated with at least 30 percent crop residue and substantially

less soil erosion than other ti llage practices (US - EPA, 2009 ) . Almost 40% of f ull season so ybean acreage is under no - till practice, while another 23% is under a specialized ty pe of conservation tillage. Another 20% of so ybean acres are intensivel y tilled. In addition to preplant tillage preparations, cultivation for weeds might al so be undertaken because a preplant residual herbicide was not activated by precipitation, and immediate control is21

required ( IP MCenters, 2011 ) . Pre - emergence herbicides may also n eed activation, and failing adequate rainfall, rotary

hoes or harrows may

be deployed at soy

bean emergence ( IPMCenters, 2011 ) . Weed escapes from herbicide treatment may also be re medied with shallow cultivation ( IP MCenters, 2011 ) . Nitrogen Fertilization Soy beans remove up to 70 pounds of nitrogen from the soil when a 50 - bushel yield of so yb ean is attained, with only

about 35% of that originating from soil ( Hoeft et al., 2000 ) . The remaining nitrogen needs of so yb ean come from s ymbiotic nodulating bacteria of the families Rhizobiaceae and Bradyrhizobiaceae, and these form a s ymbiotic relationship with soy b ean ( Gage, 2004 ) . The sy mbiosis between nitrogen - fixing plant - microbe and the plant results in the formation of root nodules, providing an environment in which differentiated bacteria reduce or fix atmospheric nitrogen. The product of nitrogen fixation, ammonia, then can be used b y the plant ( Gage, 2004 ) . USDA - ERS (USDA - ERS, 2010e ) estimates that less than 40% of soy bean acres in the U . S . receive nitrogen fertilizer. Given the important role of these bacteria for meeting nitrogen needs of so ybean, commercial sources of inoculants such as multiple strains of Bradyrhizobium can be applied to soy

bean seeds just before plant ing ( Beuerlein, 2005 ) . These b acteria must be supplied if a soy

bean crop has not been recentl y grown on the field ( Bottomley , 1992 ) , and if nodulation is inadequate, supplemental nitrogen may be required for the developing crop ( Ferguson et al., 2006 ) . Maintaining an optimal pH is important to proper initiation of nodulation, and in a ty

pical corn - soy

bean rotation, pH of about 6 is a good target ( Hoeft et al., 2000 ) . Weed Control One of the highest priorities in soy bean production is weed management ( Hoeft et al., 2000 ) . Weeds compete with so ybean for water, soil nutrients and light, and may ultimately reduce yield. Growers use cultural methods, cultivation and herbicides to control crop competitor s, 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 soy

bean yield losses ranging from 12 to 80% ( Barrentine, 1989 ) . U.S. soy bean farmers began augmenting tillage with herbicides to control weeds in the late 1950s, but tillage in crop production remained an important strategy ( Gunsolus, 1990 ) . By the earl y 1990s, there were over 70 individual h erbicides or combination products registered for weed control in so ybean ( Gianessi et al., 2002 ) . As additional herbi cides became available, the possibility

of the conservation - enhancing use of reduced tillage or no - till became feasible ( Givens et al., 2009 ) . Next, as herbicide - tolerant GE crops were no longer subject to the regulatory

requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act beginning in 1996, a larger number of growers were able to adopt conservation tillage strategies ( Givens et al., 2009 ) . The use of herbicides is directly related to choices made by soy bean producers for tillage options. Herbicides can directly substitute for tillag e, and their use often offers better management than tillage alone ( Gianessi and Reigner, 2007 ) . Consequently , as noted, there has been a trend towards less tillage as a greater number of herbicide choices and options have22

become available. As herbicide - resistant crops were offered an d deployed, increased amounts of conservation tillage began to be practiced, since particularl y wide spectrum herbicides (such as gl yphosate) could be used on soybean. Although herbicide - tolerant varieties have become the most widely

planted so ybean in th e U.S. (9 4 % of all soy bean acreage in 201 1 (USDA - ERS, 2011a) ), especiall y Roundup Ready® varieties, the developer of the technology still recommends that growers add tillage or other herbicides, as appropriate, in their Roundup Ready® soy bean production methods ( Monsanto, 2011 ) . Foxtail spp., pigweed, velvetleaf ( Abutilon theophrasti), lambs quarters ( Chenopodium album ), and cocklebur (

Xanthium strumarium ) are common annual weeds in Midwest corn and so yb ean fields. However, growers consider giant ragweed ( Ambrosia artemisiifolia ), lambs quarters, Canada thistle ( Cirsium arvense ), cocklebur, and velvetleaf to be the top five most problematic weeds in corn and so ybean b ecause of the difficulty of control ling these weeds (Nice and Johnson, 2005 ) . For Minnesota soybean, yellow foxtail, common ragweed and common lambsquarters are prominent, with winter annuals such as must ards, horseweed, and biennials such as wormwood important weeds; perennial broadleaf weeds include Canada thistle, common milkweed and hemp dogbane which can be difficult to manage in so ybean ( Potter and Ostlie, 2003 ) . Eighty- six common weeds of so yb ean across three growing regions (Midwest, Mid South, and Eastern Coastal) were identified in another soy bean petition for nonregulated status (pages 150 - 151 in ( Monsanto, 2010a) ). Commercial soy

bean production may

require at least one herbicide application for effective weed control. Most commonly , weeds are controlled by planting gl yphosate - tolerant so ybean varieties, and applying gly phosate at least once during production. In some places gl yphosate resistant weeds have been reported, such as pigweed and morning glory ( Heatherl y et al., 2009 ; Woodruff et al., 2010 ) . These resistant weeds can be managed b y appl yi ng herbicide combinations with different modes of action, as well as crop rotation, varying row spacing, and mechanical removal of weeds ( Woodruff et al., 2010 ) . In 2002, it was calculated that 96 percent of all planted so ybeans were treated with at least one ty pe of herbicide, ranging from 0.04 to 0.71 pounds (lbs) of product per acre. In 2006, herbicides were used on 98 percent of soy bean acres of surveyed states (USDA -NASS, 2007b ) . Table 5 shows principle herbicides used on so ybean in two Northern Tier states. Weed species are also discussed in Section 2.4.2, Plant Communities.23

**Table 5. Princip**  **al h**  **erbicides u**  **sed in s**  **oybean p**  **roduction and p**  **ercentage of a**  **cres a**  **pplied —**  **s elected**  **s tates**  **. State**  **Herbicide**

**Glyphosate 2,4**  **- D**  **Imazathapyr Pendimethalin**  **Clethodim Trifluralin**  **Percent of total acres applied** Wisconsin* (2006) 85 11 9 9 -- -- Minnesota** (2007) 91 -- -- -- 2 2 Sources: * NASS, Wisconsin Field Office (USDA -NASS_Wisconsin - Field - Office, 2009 download) . ** Minnesota Department of Agriculture ( MDA, 2009 ) . Various other pesticides may also be used for soybean production, including insecticides, fungicides , and nemat i cides. In 2006, insecticides were used on 16 percent of soybean acres. The three most common insecticides, lambda - cy halothrin, chlorpy

rifos, and esfenvalerate, were applied to 6, 5, and 3 percent of the planted acres, respectivel y ( USDA -NASS, 2007b ) . In addition to these three insecticides, a total of 10 other insecticides are recommended for use on soy beans for aphid control (UM, 2011 ) . 2.2.3 Soy

bean Seed Production Soy bean seed is separated into four seed classes: 1) Breeder; 2) Foundation; 3) Registered; and 4) Certified (see, e.g., ( MCIA, 2009 , 201 0 ) ). Each class of seed is identified to designate the seed generation from the original breeder source ( Hartman and Kester, 1975 ) . The original seed breeder seed stock is controlled by the developer of the variety ( Adam, 2005 ; Hartman and Kester, 1975 ) . The Breeder stock is used to produce Foundation seed stock (Adam, 2005 ) . Foundation seed stock, in turn, is used to produce Registered see d for distribution to licensees, such as seed companies ( Adam, 2005 ) . Registered seed is used b y seed companies to produce large quantities of Certified seed ( Adam, 2005 ; Hartman and Kester, 1975 ) . The Certified (or Select) seed is then sold to growers through commercial channels (Adam, 2005 ; Hartman and Kester, 1975 ) . Seed quality

(including genetic purity, vigor, and presence of weed seed, seed - borne diseases, and inert materials such as dirt) is a major requirement for successful seed crop production. If natural variability

and environmental effects upon seed production are not carefully controlled, the value of a new variety or cultivar may

be lost ( Hartman and Kester, 1975 ) . Genetic purity in commercial seed production is generall y regulated through a system of seed certification which is intended to ensure that the desired traits in the seed are maintained throughout al l stages in cultivation ( Hartman and Kester, 1975 ) . States have developed seed laws and certification agencies to ensure that purchasers who received certified seed can be assured that the seed meets established seed quality standards ( Bradford, 2006 ) . The U.S. Federal Seed Act of 1939 recognizes seed certification and official24

certifying agencies. Implementing regulations further recognize land history , field isolation, and varietal purity standards for Foundation, Registered, and Certified seed. Foundation seed, Registered seed, and Certified seed production is controlled by public or private seed certification programs (AOSCA, 2009 ) . Commercially certified soy

bean seed must meet state and Federal seed standards and labeling requirements. Federal Seed Act regulations are detailed in 7 CFR 201. State see d certification standards may vary slightly from state to state and can be more restrictive than the seed standards of AOSCA (Association of Official Seed Certifying Agencies) ( GCIA, 1988 ; NCCIA, 2011 ; Seed Certification Department, 2001 ) . The values for certified so yb ean seed standards from AOSCA are as follows ( AOSCA, 2009 ) :  98% pure seed (minimum);  2% inert matter (maximum);  0.05% weed seed (maximum; not to exceed 10 per pound (lb));  0.60% total of other crop seeds (maximum);  0.5% other varieties (maximum; includes off - colored beans and off

- type seeds);  0.10% other crop seeds (maximum; not to exceed three per lb); and  80% germination and hard seed (minimum). In addition to these specific factors, so ybean certification standards identify land requirements and field practices that must be fol lowed. Soy beans must be grown on land on which the previous crop grown was of a different type, certified seed of the same variety, or a variety having noticeable characteristic differences. In addition, for every 200 certified soy

bean plants, only one of f - ty pe or other variety is allowed (AOSCA, 2009 ) . Certified seed crop is subject to field inspections by

certifyingagencies 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 soy bean seed sold may

not be officiall y certified; however, commercial soybean seed sold and planted for normal soy bean production is produ ced predominately to meet or exceed certified seed standards. Seed certification sy stems should be distinguished from identity preservation sy stems for certain agricultural commodities. Soy bean Identity Preservation ( IP ) refers to a s ystem of production, handling, and marketing practices that maintains the integrity and purity of specialty crop products ( Sundstrom et al., 2002 ) . MON 87769 soy bean is expected to be handled and marketed within the practices of the certified seed s ys tem, and is expected to meet all state and f ederal seed standards and labeling requirements. 2.2.4 Organic So ybean Production In the U.S., only

products produced using specific methods and certified under the USDA’s Agricultural Marketing Service (AMS) National Organic Program (NOP) definition of organic farming can be marketed and labeled as “organic” (USDA - AMS, 2010 ) . Organic certification is a process - based certification, not a certification of the end product; the certification process specifies and audits the methods and procedures by which the product is produced.25

In accordance with NOP, an accredited organic certifying agent conducts an annual review of the certified operation’s organic sy stem plan and makes on - site inspections of the certified operation and its records. Organic growers must maintain records to show that production and handling procedures compl y with USDA organic standards. The NOP regulations preclude the use of excluded methods. The NOP provides the following guidance under 7 CFR Section 205.105: ...to be sold or labeled as “100 percent organic”, “organic” or “made with organic (specified ingredients or group(s)),” the product must be produced and handled without the use of:... (a) S ynthetic substances and ingredients,... (e) Excluded methods,... Excluded methods are then defined at 7 C FR Section 205.2 as: A variety of methods used to geneticall y modify organisms or influence their growth and development by means that are not possible under natural conditions or processes and are not considered comp atible with organic production. Such m ethods 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 b y recombin ant DNA technology). Such methods do not include the use of traditional breeding, conjugation, fermentation, hy bridization, in vitro fertilization, or tissue culture. Organic farming operations, as described b y the NOP, are required to have distinct, defined boundaries and buffer zones to prevent unintended contact with excluded methods from adjoining land that is not under organic management. Organic production operations must also develop and maintain an organic production sy stem plan approved b y their accredited certifying agent. This plan enables the production operation to achieve and document compliance with the National Organic Standards, including the prohibition on the use of excluded methods (USDA AMS, 2010 ) . Common practices organic growers may use to exclude GE products include planting onl y organic seed, planting earlier or later than neighboring farmers who may be using GE crops so that the crops will flower at different times, an d employing adequate isolation distances between the organic fields and the fields of neighbors to minimize the chance that pollen will be carried between the fields ( Baier, 2008 ; Bradford, 2006 ; NCAT, 2003 ; Sundstrom et al., 2002 ) . Although the National Organic Standards prohibit the use of excluded methods, they do not require testing of inputs or products for the presence of excluded m ethods. The presence of a detectable residue of a product of excluded methods alone does not necessarily constitute a violation of the National Organic Standards (USDA - AMS, 2010 ) . The current NOP regulations do not specify

an acceptable threshold level for the adventitious presence of GE materials in an organic - labeled product. The unintentional presence of the products of excluded methods will not affect the status of an organic product or operation when the operation has not used excluded methods and has taken reasonable steps to avoid contact with the products of excluded methods26

as detailed in their approved organic s ys tem plan ( Ronald and Fouche, 2006 ; USDA - AMS, 2010 ) . The production of organic soy beans represents between 0.17% and 0.22% of total U.S. soy bean production (USDA - ERS, 2010d) . In 2005 and 2008, 122,217 and 125, 621 acres of so ybean in the U.S., respectivel y, were certified organic ( USDA - ERS, 2010d) . In the Northern Tier states for 2008, approximately

50,500 acres were certified organic (Tabl e 6 ), which represents less than 0.3% of the total soy

bean crop in the region ( USDA - ERS, 2010d) . Organic soy bean markets ty picall y enjo y a market premium offsetting the additional production and record - keepi ng 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

Soy bean Production Id entity Preservation (IP) refers to a s ys tem of production, handling, and marketing practices that maintains the integrity and purity of specialty crop products ( Sundstrom et al., 2002 ) . Commodity

grains are marketed e n mass e according to USDA grading standards. Specialty crops require some form of segregation or IP to keep these grains separate from commodity grains ( Elbehri, 2007 ) . This segmentation helps preserve a specified purity of the product. With certain specialty

crops (e.g., organic or designated industrial - uses), IP is required to prevent accidental or unintended commingling. Should the IP crop be admixed with a different variety , contracts between growers and purchasers define acceptable limits of suc h admixture. I f defined purity is not attained, the buyer can reject the crop, and the grower would not receive the premium price specified by the contract. Thus, financial penalty encourages the grower to maintain standards expected by the buye r and b y those users further along in the supply chain. Comments submitted in previous environmental assessments have identified issues pertaining to management practices designed to prevent accidental or unintended commingling of crops. Many of these practices are already well established in the soy bean industry as part of the crop27

cultivation practices necessary to maintain IP. The need for segregation and IP production sy stems 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 soy bean ( Sundstrom et al., 2002 ) . MON 87769 soy

bean is expected to be handled and marketed within the practices of a Closed Loop IP ( see definition in Section 4.2.5 ) production sy stem ( Monsanto, 2010b ) . Specialty Soy bean Ty pes The U.S. soybean IP production and distribution systems acc ommodate differences between commodity and specialty soybean. Production systems designed prior to the introduction of MON 87769 soybean or even prior to the introduction of biotechnology - derived soybean allow for production of specialty soybean varieties to meet varied customer demands. Although soybeans are primarily a commodity crop, there is an existing specialty soybean market. Distinct identity - preserved specialty soybean with such traits as clear hilum or high protein have been grown and successfu lly marketed for specific food uses in domestic and export markets for many years ( Cui et al., 2004 ) . Specialty soybeans can be grouped into several broad categories ( Monsanto, 2010b ; UK, 2010 ) including :  non - biotechnology - derived ,  certified seed ,  organic food - gr ade ,  low saturated fat ,  clear hilum ,  tofu ,  natto ,  high sucrose ,  high oleic ,  low linolenic , and  high protein. The categories refer to soybean with characteristics such as altered seed composition (e.g., low saturated fat, high sucrose, high oleic, low linol enic, and high protein), varieties of soybean with unique physical characteristics suited to their specific uses (e.g., clear hilum for direct human consumption), or refer to a production process (e.g., organic, certified seed). The categories are not meant to be exclusive; for example, soybean used to produce natto or tofu may employ organic production processes. Moreover, soybeans of all specialty categories are often derived from varieties produced according to certified seed production practices. Tof

u and soymilk produced from the tofu soybean category represent a large segment of the specialty soybean market and are produced from unique soybean varieties that have clear hilum and large seed size ( Lee and Herbek, 2004 ) . Tofu varieties also must be high in protein (40% or higher) and low in oil concentration compared with commodity soybean. Clear hilum (i.e., the small scar marking the seeds former place of attac hment to the pod) and other characteristic are required for soybean used in the production of other28

soybean food products consumed directly by humans such as natto, soybean sprouts, edamame (vegetable soybean), and soy nuts ( Lee and Herbek, 2004 ; UK, 2010 ) . The majority of these specialty soybean varieties are offered in Maturity Group II and early Group III varieties which are adapted to the upper Midwest/Great Plains region ( Lee and Herbek, 2004 ) . Vistive ® soybean with low linolenic traits are offered by Asgrow in M aturity Groups 2.0 to 3.6 ( Asgrow, 2011 ) . Specialty Soy bean Production Specialty soybean varieties are specified by buyers and end - users of soybean for p roduction, and premiums are paid for delivering a product that meets purity and quality standards for the soybean variety. Product differentiation and market segmentation in the specialty soybean industry includes mechanisms to keep track of the soybean ( traceability), methods for IP , such as quality assurance processes (e.g., ISO 9001 - 2000 certification), as well as contracts between growers and buyers that specify delivery agreements. The distinction between the commodity soybean and the specialty soybean involves both certified seed production as well as IP of the harvested crop. The majority of soybean in the U.S. is cultivated and marketed as a commodity for the oil and protein mark ets ( Monsanto, 2010b ) . The goal of the commodity supply chain is to supply a homogenous product to the end user. Although the grower producing soybean for this chain may choose from many different varieties for culti vation, the harvested soybean is viewed to be the same for all commodity soybean varieties ( Monsanto, 2010b ) . At harvest, the grower either delivers soybean to a handler or stores them on farm for later delivery. Th e commodity soybean is not differentiated for later use. Commodity soybean handlers typically have large volume storage capacity, and commodity soybean processors crush large volumes of soybean to produce homogeneous oil and meal products. The commodity system is designed to maximize efficiency at a low profit margin and results in comingling of different sources of soybean. The beneficial consequence of mixing soybean in the initial crush, increased homogeneity, is also one that does not affect the price received for the final product. This production system has been in place in the U.S. since the production of soybean began in earnest in the 1960s ( Sonka et al., 2004 ) . The specialty so ybean market produces so ybeans that have specific ph ys ical or chemical characteristics to meet specific buye r requirements. As a re sult of these special needs, a separate specialty soy bean channel has developed for the specialty soybean product that involves much smaller volumes than commodity soy bean ( Smy

th and Phillips, 2002a ; Sonka et al., 2004 ) . Specialty soy bean varieties are produced on approximately 12% of the U.S. soy

bean acreage an d, according to the Midwest Shippers Association ( MSA, 2009 ) , this acreage could grow to over 25% of the crop acreage in certain states within the next decade. In Iowa, 13.5% of soy bean acres were planted to specialty so ybean, and about hal f of these acres were either non G E crops or for seed production ( Goldsmith et al., 2008 ) . Fehr reporte d that in 2006, about 700,000 acres in the U . S . were planted to low and ultralow linolenic acid varieties ( Fehr, 2007 ) .29

The specialty so ybean supply chain ty pically start with a firm that contracts production of a specific variety and sets standards for quality of the harvested soy bean ( Lee and Herbek, 2004 ) . In return, growers receive a premium over the price paid for commodity soy bean. Growers may store harvested so ybean on farm or deliver the product directl y to an approved processor or to special containers for international shipment . The IP practices used in specialty soybean production require that all equipment and storage facilities for specialty soybean must be clean of seed from other soybean varieties or plants, dirt, pathogens, and other foreign material ( Hanna and Jarboe, 2005 ) . Some soybean contracts may require a special inspection of the handling and storage facilities. The specialty soybean for soybean foods may require special harvesting equipment because some of these soybeans are harvested before full maturity (e.g., edamame or vegetable soybean) ( Ernst and McNulty, 2011 download) . For specialty soybean, weed control is extremely important in order to maintain a high yield potential. Weeds , such as nightshade ( Solanum nigrum ), can stain harvested soybean, which is particularly undesirable in food - grade soybean ( TCM, 2008 ) . Soy bean Varieties and Altered Fatty Acids The genetic changes in soy beans that resulted in altered soy bean oil composition have been achieved b y both conventional and genetic engineering techniques. Varieties were improved conventionally

by genetic selection and mutagenesis techniques. Among the cultivars currentl y grown for commercial production are those for reduced palmitic and l inolenic acids ( Fehr, 2007 ; Goldsmith et al., 2008 ) . Non - GE soy bean breeders also have obtained varieties with greater than 70% oleic acid b y s election and intercrossing ( Alt et al., 2005 ) . Nontransgenic lines include those which express low linolenic acid, an oil trait which does not require trans - hydrogenation to improve oil properties and increase product stability . Aso yi a formerl y offered an ultralow linolenic variety at 1% of fatty acids ( Qualisoy , 2011 ; Wilkes, 2008 ) and Iowa State has made some lines available to growers (http://www.notrans.iastate.edu/). Low saturated fat soy beans are also available from Iowa Natural (1% linolenic, 7% saturated fats of total oil) (American Heart Association, 2011 ; NYC DOH, 2009 ) . Low linolenic soy beans with GE herbicide tolerance are marketed by Monsanto (‘Vistive’) and Pioneer (‘Plenish’) seed companies, with linolenic acid expressed at less than 3%. The Vistive line was planted on 1.5 million acres in 2008 ( Monsanto, 2008 ) . Genetic engineering techn iques have been used to increase oleic acid composition in soy bean to near 80%, but the first altered fatty acid variety no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act (APHI S Petition # 97 - 008 - 01p (USDA - APHI S, 1997 ) ) has not been planted on a large commercial scale since 2005 because the developer changed its market strategy. This line is no longer commercially available. Another GE high oleic acid variety , DP - 304423 - 1 with a high oleic phenotype conferred by introduction of the soy

bean omega - 6 desaturase gene 1 ( fad2 - 1 gene) was no longer subject to the regulatory

requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act , but will not be released commercially until 2012 (Plenis h ( Pioneer Hi - Bred, 2011 ) ). Other30

soy bean with altered fatty

acids have also been petitioned for non - regulated status (MON 87705 high oleic so ybean). Non - herbicide Tolerant Soy bean In the US, n on - herbicide tolerant soy bean varieties (conventional, nontransgenic) in the U.S. were planted on approximately 8% of the total soy

bean acres in 2008 ( Fernandez - Cornejo et al., 2002 ) , and many of these are specialty soybeans ( Lee and Herbek, 2004 ) . Specialty soy bean varieties include tofu, natto, bean sprouts, edamame, soynuts, as well as those with unique chemical identities, such as those with modified fatty acid profiles, high protein or high sucrose content. Farm production of these so ybean s is essentially the same as for conventional soy beans, although for specific varieties, there may be less tolerance for accidental admixture with weed seeds such as nightshade and pokeweed seeds which can stain the soybean seed ( Lee and Herbek, 2004 ) . **2.3 Physical Environment**  2.3.1 Water Resources The ty pical amount of water required for a high - yielding so ybean crop is approximately 20 inches during the growing season ( Hoeft et al., 2000 ) . Annual state - wide precipitation data collected for the 5 - state region where MON 87769 soy bean may be grown (i.e., North and South Dakota, Minnesota, Wisconsin, and Michigan) ranges from approximately 18 to 33 inches (NOAA, 2 011 download ) . While normal climatic conditions may provide sufficient water to produce a so yb ean crop, precipitation may vary across a state and from year to year and irrigation may

be needed to supplement precipitation amounts. Irrigation of soy bean acres, according to data from the USDA 2007 Census of Agriculture, is used on 4.6 to 15% of soy bean acres in the five - state region where MON 87769 soy bean may be cultivated (USDA -NASS, 2007c , 2010 ) . In some limited areas, such as central Minnesota, soy bean is usually

produced under irrigated conditions (deJensen et al, 2004), and this may be a consequence of the soil characteristics in specific areas. So ybean acres that are irrigated are a small portion of total soy bean acres, much less than those acres irrigated for corn (Table 7) (USDA -NASS, 2007c ) . **Table 7**  **. Irrigation of soybean acres in Northern Tier states. State**  **Harvested 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 1531

Wisconsin 8,884,628 1,363,124 373,680 24,855 6.6 United S tates 309,607,601 63,915,821 86,529,391 2,175,069 2.5 a. Table 1, State Summary Highlights: 2007 (USDA -NASS, 2009 ) b. Source: Soybean Irrigated Harvested Acres: Table 33, 2007 Census of Agriculture

– State Data (USDA -NASS, 2007c ) c. To tal acres from (USDA -NASS, 2007c ) . In most states, irrigation water comes predominantly from groundwater sources, with comparativel y little derived from surface water sources (Table 8) . **Table 8**  **. Water sources used for irrigation of soybean acres in Northern Tier states.** 

**State Irrigated** 

**harvested soybean 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 Survey 2008, Table 29 (USDA -NASS, 2010b ) . Notes: Some farms may obtain water from multiple sources.

- - – No irrigation NA

– Not applicable ND

– No data available. Agricultural non - point source (NPS) pollution is the primary source of discharge pollutants to rivers and lakes and a major contributor to groundwater contamination. The EPA lists the most important cause of impairment in assessed streams and rivers as pathogens, with sediment second, and nitrogen third; pesticides are onl y the 16 th most important (EPA, 2012). Agricultural m anagement practices that contribute to NPS p ollution include the ty pe of crop cultivated, plowing and tillage, and the application of pesticides, herbicides, and fertilizers. Agricultural pollutants released b y soil erosion include sediments, fertilizers, and pesticides that are introduced to area lakes and streams when they are carried off of fields by rain or irrigation waters ( US - EPA, 2005 ) . Excess sediment can directly affect fish and other wildlife mortality and reduce the amount of light penetration into a body of water. Indirectly , soil erosion mediated sedimentation can increase fertilizer runoff , and facilitate algal blooms and oxygen depletion in a body

of water (US - EPA, 2005 ) . Agriculture may

contribute to several types of chemicals found in water resources. These include nitrogen and phosphorus from applied fertilizers, which, when present at high32

concentrations, may

lead to eutrophication of surface water , resulting in changes in dissolved oxygen concentrations and frequent algal blooms ( Carpenter et al., 1998 ) . Other chemicals found in surface water runoff may include various pesticides (both herbicides and insecticides) which, at high concentrations, may impact humans, plants and animals that are exposed to the affected water ( Domagalski et al., 2008 ; Vogel et al., 2008 ) . Some pesticides used on so ybeans were detected b y Vogel et al. (2008) in rainwater, such as chlorp yri fos (64% of samples in a four state pattern). In addition t o direct impacts to surface water, agricultural chemicals may eventuall y impact groundwater when transported by infiltrating surface or irrigation water. Irrigation with locall y pumped water tends to reduce transport of chemicals in ground water because it avoids connecting streams with groundwater ( Domagalski et al., 2008 ) . Ground water and aquifers may be impacted by

agricultural chemicals via infiltration as well. In areas where so ybean and corn are grown in rotation, such as Nebraska, and where ground water is a principle source of water for human consumption, this can be a critical issue ( Stanton et al., 2007 ) . In other areas, surface water movement of contaminants is at issue, and agricultural tile drainage s ys tems have been shown to be a source of nitrate entering streams and rivers ( Randall and Mulla, 2001 ) . In areas where water retenti on in fields is high, periodically impeding crop production, such subsurface drainage s ys tems are commonly employed ( Hoeft et al., 2000 ) . Conservation tillage and no - till practice have been shown to minimize surface water runoff and soil erosion, and as a result, help re duce the effects of nutrient runoff on water resources. By improving soil quality , the consequent increase in soil organic matter promotes the binding of nutrients, as well as pesticides and herbicides, to soil and prevents their loss to surface waters an d groundwater from runoff, erosion, and leaching ( Leep et al., 2003 ) . 2.3.2 Soil Quality Arable land supports a rich and complex community of below - ground microorganisms and arthropods. The interaction between the below - ground community , plant root suture, and organic residues in the so il is central to a variety of dynamic soil ecological processes, including the decomposition of organic material, subsequent nutrient cycling and release, and the associated maintenance of s oil structure and composition. Soil Ty pe Soil texture and structure are key components determining water availability in soils which, in turn, affects so ybean root depth and density. Soy beans are grown on a variety of soil types, ranging from small particles (clay), medium particles (silt), and large particles (sand). Silt loam particles’ medium size, good aeration, fertility , high water - holding capacity and abundance of organic matter make it the ideal soil for soy bean cultivation ( Hoeft et al., 2000 ) . As medium textured soils are able to hold more available water, the soy bean roots in medium textured soils are denser and extend to a ty pical depth of 1.2 m eters . By contrast, soils that are more comp act (e.g., clayey

soils) hold less water and, as a result, the soy bean plant root mass is less dense and shallower. The disadvantages of clay soils include their tendency to clump and impede drainage when tilled at too low or too high moisture levels , leading to less aeration and a tendency toward erosion ( Hoeft et al., 2000 ) . The ideal pH for so ybean growth is 6.0, with yield declining at a pH less than or equal to 5.8 ( Heatherl y et al., 2009 ; Hoeft et al., 2000 ) .33

The soils found in the N orthern T ier states are of varying ty pes but predominately

Moll isols and Alfisols . S oil surface layers of Mollisols are generally thick and dark and are among some of the most important soil ty

pes in both world and U . S . agriculture ( McDaniel, 2011 ) . Alfisols may ty picall y have a layer of clay beneath a surface layer of relativel y high fertility ( McDaniel, 2011 ; Soil Survey

Staff, 1999 , 2010 ; US - EPA, 2009 ) . Additionally, another type of soils found in the five states of interest are Vertisol s which are clay soils that expand when wet and shrink with cracking when drying ( Soil Survey Staff, 1999 ) . Also, other soils present in this region include Entisols, many

of which are sandy or have very shallow surface layers , and Histosols, having high organic material i n upper layers, and which overlay rock, cinders or pumice. Soil Disturbance/Degradation Cultivation of soy

bean directl y impacts the qualitative and quantitative attributes of soil. For example, conventional tillage and mechanized harvesting machinery may disturb and expose the top soil surface layer, leaving the land prone to degradation. In turn, degradation of soil structure and composition may

lead to decreased water retention, a decrease in soil carbon aggregation and net positive carbon sequestration , and increased emission of radiatively- active gases that contribute to the greenhouse effect (e.g., carbon dioxide ( 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 li kely to negativel y affect water resource quality and communities of organisms dependent on those water resources. Soil Biota Mutualistic relationships with beneficial microorganisms are essential to soy bean growth. Being a legume plant , the so ybean plant f ixes a significant portion of its own nitrogen through the sy mbiotic relationship with the nitrogen - fixing Bradyrhizobia bacteria ( Bradyrhizobium japonicum ) that live in soy bean root nodules ( Hoeft et al., 2000 ) . The so ybean root nodules contain colonies of bacteria which take gaseous nitrogen from the atmosphere and fix it in forms easily used by the so ybean plant. Because the nitrogen - fixing bacteria are not native to U.S. soils and would not normally be found in these soils, soy beans are frequently

inoculated with thes e bacteria prior to planting, especially if soy bean has not been grown in a field for three to five years ( Pedersen, 2007 ) . In addition to Rhizobium , b eneficial microorganisms to the soy bean plant include mycorrhizal fungi that attach to so ybean roots and extend hy phae deep into the soil, effectively increasing soy bean access to nutrients and water ( Purves et al., 2004 ) . In addition to increasing so yb ean access to water and nutrients, mycorrhizal hy phae also facilitates pore creation in soil through particle aggregation, an important effect in clay soils that do not aerate well ( Heatherl y and Hodges, 1999 ) . Both Rhizobium and m yc orrhizae aid plant survival during drought. M yco rrhizal - colo nized non irrigated so ybeans have shown a 10 percent increase in yield compared to non - colonized non irrigated so ybeans during a drought period. These two mutualistic sy mbioses have been shown to occur concurrently , with mycorrhizae having a positive impa ct on Rhizobium nodulation and the nitrogen - fixing activity of nodules present on the soy bean plant. These soy

bean plants also provided a greater yi eld ( Heatherl y and Hodges, 1999 ) .34

2.3.3 Air Quality Agricultural Air Pollutants and Emissions Sources A gricultural impacts on a ir 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, an d airborne allergens. The seven NAAQS criteria pollutants are carbon monoxide (CO), lead, 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 microm eters in aerodynamic diameter (PM 2.5 ), ozone (O 3 ), and sulfur dioxide (SO 2 ) (US - EPA, 201 0c ) . The main GHGs that enter the atmosphere because of agricultural activities include: c arbon dioxide (CO 2 ) , m ethane (CH 4 ) , and n itrous o xide (N 2 O) . In addition to CO 2 , ammonia is also another trace gas from agriculture ( Krupa et al., 2006 ) . Emissions from crop agriculture can be broken down into two main categories

 emissions related to working fields, such as dust and equipment emissions, and emissions from the soil and plants. Emiss ions released from agricultural equipment (e.g., irrigation pumps and tractors) include CO, nitrogen oxides, reactive organic gases, particulate matter, and sulfur oxides (US EPA, 2010b ) . Agriculture 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 particulate concentrations coincide with the peak agricultural harvest season in Califor nia’s Central Valley ( Giles et al., 2006 ) . Primary agricultural air emission sources of other pollutants include soil particulates associated with tillage; smoke from agricultural burning, pesticide drift from spraying; and aerial application of pesticides which all may cause air quality

impacts b y drift and diffusion. Atmospheric wet and dry deposition of nitrogen, mineral nutrients, and organic compounds to cropping s ys tems can have feedback effects on trace g as emissions from fields ( Krupa et al., 2006 ) . Agricultural pesticides may also enter the atmosphere through volatilization from soil and plant surfaces and through wind erosion and can be re turned to the surface through precipitation or dry

deposi tion processes (Vogel et al., 2008 ) . Primary agricultural air emission sources of GHGs include: CO 2 from agricultural burning; vehicle exhaust associated with equipment used in tillage and harvest; and N 2 O emissions from the use of nitrogen fertilizer (Aneja et al., 2009 ; Hoeft et al., 2000 ; US - EPA, 2010a ; USDA NRCS, 2006a) . Agriculture, including land - use changes for farming, is responsible for an estimated 17 to 32 percent of all human - induced GHG emiss ions. Herro ( Herro, 2008 ) proposes that if agriculture practices were modified, significant reductions in the release of GHGs would be expected. Compliance and enforcement of emiss ion rules may be regulated at state, local, and federal levels, but for most GHGs there are no applicable regulations of these gases arising from agricultural burning. Agricultural burning generates smoke that consists of particulate matter, including a co mplex 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, carbon35

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 so ybean crops is usually not recommended by

State Extension Services, but burning of corn preceding a corn crop in a corn - soy bean rotation is sometimes indicated (Minnesota ( Rehm, 2009 ) ; North Dakota, ( Franzen and Nowatzki, 2009 ) ). More likely, agricultural fires in soy bean acreage occur as accident al events in hot and dry fall conditions ( Sawyer, 2000 ) . These fires are more likel y to occur in corn, but fires in rotation crops such as wheat and so ybean 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 (μ m) in diam eter ( Li et al., 2007 ) . Within the affected area for this EA, there are onl y two non - attainment areas for PM 2.5 : three - county Milwaukee - Racine , WI area and the seven - county Detroit - Ann Arbor , MI area (US EPA, 2011b ) . Greenhouse Gases Primary agri cultural air emission sources of GHG include: CO 2 from agricultural burning; vehicle exhaust associated with equipment used in tillage and harvest; and nitrous oxide emissions from the use of nitrogen fertilizer (Aneja et al., 2009 ; Hoeft et al., 2000 ; US - EPA, 2010 a ; USDA -NRCS, 2006a) . Agriculture, including land - use changes for farming, is responsible for an estimated 6% of all human - induced greenhouse gas (GHG) emissions in the U.S. (US - EPA, 2010a) . Agricultural emissions sources of GHGs include:  Livestock are responsible for the largest fraction of methane emissions (80% of total methane via enteric fermentation and manure management) ( US - EPA, 2010a) .  Agricultural equipment (e.g., irrigation pumps and tractors) release carbon monoxide, nitrogen oxides, reactive organic gases, particulate matter, and sulfur oxides (US - EPA, 2010a) .  Agricultural soil management practices, including nitrogen - based fertilizer application and cropping practices, are the largest source of U.S. 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 classes of crops, location and soil ty pes associated with the practices, and energy

consumption ( Cole et al., 1997 ; US - EPA, 2010a) . GHG may be indirectly

affected by

the class of crop planted and soil ty pes; trees, grasses and field crops each play

a slightl y different role in the global cycle of GHG ( Cole et al., 1997 ; Freibauer et al., 2004 ; US - EPA, 2010a) . For example, emissions of nitrous oxide, produced naturally in soils through microbial nitrification and denitrification, can be dramaticall y influenced b y fertilization , introduction of grazing animals, cultivation of nitrogen - fixing crops and forage, retention of crop residues (i.e., no - till conservation), irrigation, and fallowing of land (US - EPA, 2010a) . These same agricultural practices can influence the decomposition of carbon containing organic matter s equestered in soil, resulting in conversion to carbon dioxide loss to the atmosphere ( US - EPA, 2010a) . Conversion of cropland to pasture results in an increase in carbon and nitrogen sequestration in soils (US - EPA, 2010a) .36

The EPA has also identified regional differences in GHG emissions associated with agricultural practices on different soil ty pes, with high mineral content soils responding to GHG differentl y than high - organic content soils (US - EPA, 2010a) . Mineral soils contain from 1 to 6% organic carbon b y weight; conversion of such soils from their native state to agricultural uses can cause as much as 50% of the natural organic carbon to decompose and be released to the atmosphere (US - EPA, 2010a) . In contrast, organic soils may contain as much as 20% carbon b y weight (US EPA, 2010a) . When such organic soils are prepared for agricultural use, the soils are aerated, accelerating decomposition and release of CO 2 to the atmosphere ( US - EPA, 2010a) . Tillage, Fertilization, and Greenhouse G ases Tillage 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 crops may encourage increases in the adoption of conservation tillage programs whose consequences may include reductions of many of these emission concerns. Special conservation tillage field equipment can often perform the equivalent functions of several standard implements, reducing the necessity for multiple passes through the field. Implementing CT practices can lead to both economic and production quality benefits, as well as having positiv e environmental impacts (USDA -NRCS, 2006b ) . Tillage 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 matter ( Baker et al., 2005 ) . GHGs and Nitrogen Fertilizer Nitrous oxide emissions are released following use of nitrogen fertilizer and the action of soil microbes on soil constituents. Massive overuse of fertilizers is the biggest contributor to these emissions within the industry ; more than half of all fertilizer applied to fields ends up in the atmosphere or local waterway s each ye ar. 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 so yb ean is able to fix atmospheric nitrogen by means of s ymbiotic nodulating bacteria, nitrogen fertilization is often not indicated as a good management practice ( Rehm et al., 2001 ; Staton and Warncke, 2009 ) . Less than 40% of so ybean acres across the U.S. receive fe rtilizer application, which is appreciabl y lower than other major crops, such as corn and cotton (USDA ERS, 2010e ) . Considering these observations and recommendations, so ybean production is most likely not a large contributor to GHG emission through nitrogen fertilizer application. Pesticide Application Aerial application of pesticides may cause impacts from drift and diffusion. Pesticides may volatilize after application to soil or plant surfaces and move following wind erosion (Vogel et al., 2008 ) . Airborne chemicals may partition between gas and particle phase, be transported through wind, and then be deposited again b y rainfall or particulate settling. Vogel et al. (Vogel et al., 2008 ) from measurements of pesticide content in 4 states estimate that 2% of all applied agricultural chemicals are re - deposited v ia rainfall.37

The persistence of pesticides in the atmosphere may be an air quality

issue . Air concentrations of pesticides are typically greatest within the immediate treatment area , although, evidence also indicates that airborne chemicals may be detect ed 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 analy tes (Vogel et al., 2008 ) . Whether pesticides are applied by ground or aerial spraying or b y mechanical application to the plant surface, chemicals move to their intended and unintended targets through air, moving as droplets, dry

particles or vapors ( Carlsen et al., 2006 ; Ravier et al., 2005 ) . The distance traveled depends upon their chemical and phy sical nature, method of application, and the atmospheric conditions at time of treatment. All these influence their concentration and ultimate fate ( Carlsen et al., 2006 ) . 2.3.4 Climate Change Climate change represents a statistical change in climate conditions, and may be measured across both time and geographic spac e. U.S. agriculture may affect climate change through various facets of the crop cultivation process. Combustion of fossil fuels in mechanized farm equipment, fertilizer application, and decomposition of agricultural waste products may all contribute GHGs to the atmosphere (Aneja et al., 2009 ) . GHGs collectivel y function as retainers of solar radiation, and agricultural related activities are recognized as both direct (e.g., exhaust from equipment) and indirect (e.g., agricultural - related soil disturbance) sources of CO 2 , CH 4 , and N 2 O (US - EPA, 2010a) As summarized by

the Intergovernmental Panel on Climate Change ( IP PC ) (Technical Summary , Working Group I: The Phy sical 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 cycling between atmosphere, ocean and land and radiative forcing causing climate change ( IP C C, 2007 ) . The U.S. agricultural sector is identified as the second largest contributor to GHG emissions, ranking onl y behind the energy sector (i.e., electricity production, transportation, and related activities) (US - EPA, 2010a) . Agricultural crop commodities may also affect dynamic geophy si cal soil processes, such as carbon turnover and sequestration, through tillage and cropping s ys tem practices. In general, reduced/conservation tillage practices favor more stable and increased carbon sequestration in the agro - environment ( Lal, 2011 ) . The impacts of GE crop varieties on climate change are most likely dependent on the selected cropping s ys tems and production practices, geographic distribution of activities, and individual grower decisions. Climate Change Impacts on Crop Production Climate change may

also affect agricultural crop production. These potential impacts on the agro - environment and individual crops may be direct, including changing patterns in precipitation, temperature, and duration of growing season, or may cause indirec t impacts influencing weed and pest pressure ( Hatfield et al., 2011a ; Rosenzweig et al., 2002 ) . In response to climate change, the current range of weeds and pests of agriculture is expected to change. In response to these new ranges, current agricultural practices may be required to38

change ( IP CC, 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 in crease in crop yi eld b y 5 to 20% for this century ( IPCC, 2007 ) . However, this positive impact will not be observed across all growing regions. The IPCC report notes that certain regions of the U.S. will be negativel y impacted because available water resources may be substantially reduc ed. Note that the extent of climate change effects on agriculture is highl y speculative. Nevertheless, North American production is expected to adapt to climate change impacts with improved cultivars and responsive farm management ( IP CC, 2007 ) . Climate Change Impacts on Soy bean Production A number of impacts of increased temperature have been inferred from models of climate change. More than one model suggests that so yb ean yi elds will decline in the U . S . , mediated b y increased temperature and declining precipitation during key p eriods of the growing season ( Goldblum, 2009 ) . Besides yield penalties, increased temperatures could result in earl y season flooding and increased precipitation (which in past seasons may either delay planting, or prevent harvest). The changes in precipitation patterns would lead to crop losses, including so ybean, of up to 30% in 2030 and 65% in 2090 ( Rosenzweig et al., 2002 ) . Other modeling efforts have suggested that before the end of the century , yields could be decreased 30 to 46%, under the slowest warming scenario, and up to 63 to 82% under a rapid warming scenario ( Schlenker and Roberts, 2009 ) . The cited models suggest that impacts of climate change (specificall y, an overall deficit in total soy bean yield) would exert pressure for land alloc ations for new so ybean planting. However, the anal ys is by

Mori et al. ( Mori et al., 2010 ) suggests that land use conversion in the U . S . to mitigate the need for additional soy bean would be unlikely . Mori et al. ( Mori et al. , 2010 ) also suggest that it would be Brazil, China and South America that would likely have large conversions to soy

bean production in response to lower production efficiencies elsewhere in the world. However, some areas of the U . S . that may experienc e decreased so ybean yi eld 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 water use efficiency ( Hatfield et al., 2011b ) . Future impacts might be mitigated b y selection of varieties that showed decreased responses to the changed climate. As Betzelberger et al. ( Betzelberger et al., 2010 ) note, cultivar sensitivity to parameters such as increased ozone can have substantial deleterious impacts on soy bean yield as well. Some tropical soy b ean is less susceptible than other varieties to the increased O 3 that may typif y future environmental concentrations, and the differences are measurable in several parameters of total biomass, crop yi eld and certain biochemical markers ( Singh et al., 2010 ) . In addition, if progress in developing drought resistant crops is maintained, additional soy bean lines may be produced that will resist decreased precipitation expected over some U . S . soy bean growing areas. Finally , use of different maturity group soy bean with higher yield potential may be possible, especiall y if earl y spring occurs and the growing season is lengthened, and this and other man agement strategies could recover possible yield losses ( Ku charik, 2008 ) . From an anal ys is ( Goldblum, 2009 ) of climate change impacts on yield of corn and soy bean, timing of increased hot weather and of precipitation c an cause county by county differences within a single state. As has been shown in such an anal ys is in Wisconsin, however, increased warming in39

spring and fall (producing increased precipitation) versus increased temperature in summer (along with drought) may produce opposite impacts on soy bean yield, and empirical evidence is needed to establish overall impacts of the anticipated variations ( Kucharik, 2008 ) . **2.4 Biological Resources**  This section provides a summary of the biological environment and includes an overview of animals, plants, gene transfer, weeds and weediness, microorganisms, and biodiversity . This summary provides the foundation to assess the potential impact to plant and animal communities, the potential for gene movement, and the potential for human health impacts. 2.4.1 Animal Communities Deer and groundhogs feed on soy bean and cause soy

bean damage, while Eastern cottontail , rac coon, Canada geese, squirrels, other rodents (such as ground squirrel) also feed on so ybean but their damage is of less importance ( MacGowan et al., 2006 ) . Deer in large numbers, b y browsing in so ybean fields for forage, m ay significantly

damage soy

bean 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 primaril y on so ybean include seed - feeding insects and rodents found in agricultural fields. Rodents, such as mice or squirrels, may seasonall y feed exclusively on so ybean seeds. Thus, these animals may hav e a diet containing significant amounts of soybean seeds. Migratory birds feed on spilled soybean following crop harvest ( Galle et al., 2009 ) although more birds fed on nearb y corn and sunflower seed fie lds. As many as 28 desirable bird species, as well as another five which can be crop pests in sunflower , have been identified as resident in soybean and corn fields in the Dakotas ( Gamble et al., 2002 ) . The b iodiversity

of insect predators of a soy bean aphid in soy

bean fields have been studied in four N orthern T ier states, and relative to corn and soy bean, environments with abundances of crop and non - crop plants provided greater “biocontrol services” than does soy bean ( Gardiner et al., 2009 ) . Total insect diversity in GE gl yphosate tolerant soy bean has been compared to that in non - GE so ybean, and although mostly similar, some slight decreases of insect diversity and numbers were observed between rows of so ybean, but attributed to reduced abundance of weeds i n gl yphosate treated plots ( Imura et al., 2010 ) . Buckelew et al. ( Buckelew et al., 2000 ) also conclude that insect abundance in so ybean is more related to effectiveness of weed suppression, rather th an use of gl yphosate herbicide. Crop pest insects are considered less problematic than weeds in U.S. so ybean production; nevertheless, insect injury can impact yi eld, plant maturity , and seed quality . Consequentl y, insect pests are managed during the growth and development of soybean to enhance soybean yi eld (Aref and Pike, 1998 ; Higley and Boethel, 1994 ) . Insect injury in soy bean seldom reaches levels that cause significant economic loss, as indicated b y the low percentage (14%) of so ybean acreage that receives an insecticide treatment (USDA -NASS, 2006 ) .40

2.4.2 Plant Communities Soy bean production s ys tems in agriculture (i.e., the combination of management practices) are host to many

plant species. The environment surrounding a so yb ean field varies in plant c omposition depending on the region. In certain areas, so ybean fields may be bordered b y other soy bean varieties, corn, or other crops. In addition, fields may also be surrounded by woodlands and/or pasture/grassland areas, as well as aquatic environments . Therefore, the ty pes of vegetation, including the variety of weeds, adjacent to a soybean field depend on the area where the soy bean is planted. Annual weeds are perceived to be the greatest pest problem in soy bean production, followed by perennial wee ds ( Aref and Pike, 1998 ) . Weed control in soy bean is essential to optimizing yi elds. Weeds compete with soy bean for light, nutrients, and soil moisture. Weeds can harbor insects and diseases, and also can interfere with harvest, causing extra wear on harvest equipment ( Loux et al., 2008 ) . The primary factors a ffecting so yb ean yi eld loss from weed competition are the weed species, weed density, and the duration of the competition. When weeds are left to compete with soy bean for the entire growing season, yield losses can exceed 75% ( Dalley

et al., 2001 ) . Generally , the effects of competition increase with increasing weed density ( Monsanto, 2010b ) . The time period that weeds compete with the soy bean crop influences the level of yield loss. The later the weeds emerge, the less impact the weeds will have on yi eld. Soy bean plants withstand earl y- season weed competition longer than corn as the soy bean canop y closes earlier in soy bean than in corn ( Mallory- Smith and Za piola, 2008 ) . The extent of canopy closure regulates the availability

of light to weeds and other plants that grow below the soy bean. In addition, canop y closure occurs much sooner when soybean is drilled or planted in narrow rows. Eighty- six common weeds of soy bean across three growing regions were identified in another soy bean petition for nonregulated status ( ( Monsanto, 2010b ) ( Tables IX - 5 and IX - 6 ). Foxtail spp., pigweed, velvetleaf ( Abutilon theophrasti ), l ambs quarters ( Chenopodium album ), and cocklebur (

Xanthium strumarium ) are common annual weeds in Midwest corn and so ybean fields. However, growers consider giant ragweed ( Ambrosia artemisiifolia ), lambs quarters, Canada thistle ( Cirsium arvense ), cocklebur, and velvetleaf to be the top five most problematic weeds in corn and so ybean because of the difficulty to control these weeds (Nice and Johnson, 2005 ) . Crop rotations and environment have a significant impact on the adaptation and occurrence of weeds in so ybean. Cultural and mechanical weed control practices are important components of an effective weed management program ( Loux et al., 2008 ) . Crop rotation, narrow row spacing, and planting date are a few of the crop management practices that are implemented to provide the crop with a competitive edge over weeds ( Monsanto, 2010b ) . Although the primary purpose of tillage is for seedbed preparation, tillage is still used to supplement weed control with selective herbicides in soy bean production. Herbicides provide effective and economical control of weeds in so ybean. Approximately 98% of the soy bean acreage received an herbicide application in 2006 , indicating the importance of weed control in maximizing so ybean yi eld (USDA -NASS, 2007b ) . Herbicide - tolerant soy bean41

was introduced to provide growers with additional options to improve crop safety and/or improve weed control. In2011, herbicide - tolerant soy bean varieties represented 94 percent of planted soy

beans in the U.S. (USDA - ERS, 2011a ) . The Roundup Ready® soy bean s ys tem, i.e., planting Roundup Ready® soy bean and appl yi ng gly

phosate in crop, has become the standard weed control program in U.S. soy bean production . In the 2006 crop year, for the surveyed states, 92 percent of the planted soy bean acres were treated with gl yphosate (USDA -NASS, 2007b ) . 2.4.3 Gene Flow and Weediness Gene flow has been defined as the “incorporation of genes into the gene pool of one population from one or more populations” ( Stewart, 2008 ) . Gene flow is a basic biological process in plant evolution and in plant breeding. Gene flow, itself, does not pose a plant pest risk (USDA APHI S, 2010a ) ; it does so when specific genes with plant pest potential are incorporated into a cultivated plant. There are two ty pes of ge ne flow: horizontal and vertical. Horizontal gene flow is the movement of genes between disparate, unrelated species, such as between plants and microbes or between plants from different families ( Stewart, 2008 ) . There is no evidence that horizontal gene transfer can naturall y occur between unrelated plant species (see, e.g., ( Stewart, 2008 ; Twy

man, 2003 ) ). In plant biology , when gene flow occurs between individuals from genetically distinct populations of the same species and a new plant is formed, this is called vertical gene flow and the new plant is called a hy brid ( Stewart, 2008 ; USDA - APHI S, 2010a) . Hy bridization is usually thought of as the breeding of closel y 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 hy bridize with plants of a closel y - related species or subspecies in that new location. For natural h ybridization to occur between two distinct but related populations, the plants from the two populations must flower at the same time, they must be close enough so that the pollen can be carried from the male parent to the female parent, fertilization must occur, and the resulting embryo must be able to develop into a viable seed that can germinate and form a new plant ( Ellstrand, 2003 ; USDA - APHI S, 2010a) . Hy bridization may

occur in one generation, but in most cases, does not progress on its own through subsequent generations. If it does, and stable new populations result, the process is called intro gression. For introgression to occur, hybridization of offspring with the parental ty pes (backcrossing) must occur several times. Because hy brids of distantly

related species may not produce viable seed, introgression is much less common than hy bridizati on. For example, in studies done with canola and a weedy relative, backcrossing from the hybrids to the weeds occurred at one - hundredth to one - thousandth the rate of the original hybridization ( Stewart, 2008 ) . Nevertheless, when weed species are introduced to new areas, there is the potential that those introduced plants may hy bridize with other closely related species. Novel hy brids therefore may

be created. In addition, novel hy brids may be create d through back - crossing (i.e., introgression) with parent species which may change the native species by incorporating non native genetic material. Invasive weeds can result from hy bridization events, which mix genetic material potentially

producing a wid e array

of genoty

pes. Some of these genoty pes may exhibit increased invasive properties (USDA - APHIS, 2010a ; USDA - ARS, 2008a) .42

Characteristics that favor natural hybridization between two populations include ( Mallory- Smith and Zapiola, 2008 ; USDA - APHIS, 20 10a) :  Presence of feral populations (domestic populations gone wild) and uncontrolled volunteers;  Presence of a high number of highl y compatible relatives;  Self - incompatibility ;  Large pollen source;  Large amounts of pollen produced;  Li ghtweight pollen;  Strong winds (wind pollinated);  Large insect populations (insect pollinated); and  Long pollen viability . Additionally , the creation of a hy brid depends on a series of events including:  A pathway

for the gene of interest of one plant species to enter the population of the species t o be hy bridized (i.e., the parent plant and the receptor plant must be able to produce fertile offspring ); and  The hy

bridization must confer a fitness advantage that allows the gene, over multiple generations, to develop into a sustainable, reproducing population. The rate and success of gene flow is dependent on numerous external factors in addition to the donor/recipient plant. General external factors related to pollen - mediated gene flow include the presence/abundance/distance of sexually- compatible p lant species; overlap of flowering phenology

between populations; the method of pollination; the biology and amount of pollen produced; and weather conditions, including temperature, wind, and humidity ( Zapiola et al., 2008 ) . Seed - mediated gene flow also depends on many factors, including the absence/presence/magnitude of seed dormancy ; contribution and participation in various dispersal pathway s; and environmental conditions and events. The genus Glycine consists of two subgenera, soja and gl ycine. 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 so ybean; and G. max, the cultivated soybean. Cultivated soybean, G. max , can only hy bridize with other members of the Glycine subgenus soja ( OECD, 2000 ) . The wild and weedy relatives ( G. soja and G. gracilis ) of so ybean do not occur in the U.S. (USDA - APHIS, 2010c ) . Co nsequentl y, there is no potential for gene flow from cultivated soybean plants to wild relatives in the U.S. (USDA - APHIS, 2010b ) . Glycine soja grows wild in China, Japan, Korea, the Russian Far East, and Taiwan and is commonly found in fields, hedgerows, roadsides, and riverbanks in those countries ( OECD, 2000 ) . Although there are no wild relatives with which soy bean can share transgenes, such introduced gene s have the potential to move within cultivated varieties of so ybean. The potential for outcrossing can be defined as the ability of genes to escape to other soy bean populations. Soy bean is a highl y self

- pollinating species with a cross - pollination rate of less than one percent in plants grown in close proximity ( Caviness, 1966 ; OECD, 2000 ) . Cross - pollination at distances43

greater than 4.6 m eters (m) from a pollen source has been rarel y observed , although it has been reported that insects can sometimes transfer the pollen that distance or more ( Caviness, 1966 ) . Soy bean is not native to the U.S. and there are no feral or weedy relatives. Soy

bean is a self

pollinated species, propagated b y seed ( OECD, 2000 ) . P ollination ty pically takes place on the day the flower opens. The soy bean flower stigma is receptive to pollen approximately 24 hours before anthesis (i.e., the period in which a flower is fully open and functional) and remains receptive for 48 hours after anthesis. Anthesis normally occurs in late morning, depending on the environmental conditi ons. The pollen usually remains viable for two to four hours, and no viable pollen can be detected b y late afternoon. Natural or artificial cross - pollination can only take place during the short time when the pollen is viable. As a result, soy bean is con sidered to be a highl y self

- pollinated species, with cross - pollination to adjacent plants of other soy bean varieties occurring at very

low frequency

(0 to 6.3%) in adjacent plants ( Caviness, 1966 ; Ray et al., 2003 ; USDA - APHIS, 2010c ; Yoshimura et al., 2006 ) . Potential of soy

bean for weediness is low, and even if gene flow occurred from this variety to other commercial soy

beans, the trait (fatty acid composition changes) would not likely confer a selective advantage to the recipient so yb ean. Specific traits of soy bean also limit their potential as weeds. Mature so ybean seeds have no innate dormancy, are sensitive to cold, and are not expected to survive in freezing winter conditions ( Raper Jr. and Kramer, 1987 ) . The onl y known propagation method for soy bean is through seed germination. Because there are no reports of vegetative propagation under field conditions in the U . S . , human movement of soy bean seed is the only possible route to establishing the plant outside growing areas. Volunteer plants that might grow in previousl y planted fields or from spilled seed under some favorable environmental conditions can be easily

controlled mechanicall y or with herbicides ( Zollinger, 2010 ) . Soy bean is not weedy ( Holm et al., 1977 ) , is not found outside of cultivated areas, and does not compete well with other cultivated plants ( Hy mowitz and Singh, 1987 ) . Horizontal gene transfer and expression of DNA from MON 87769 soy bean 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 closel y associated with plants including Agrobacterium and Rhizobium ( Kaneko et al., 2000 ; Kaneko et al., 2002 ; Wood et al., 2001 ) . There is no evidence that these bacteria contain genes derived from plants. Second, in cases where review of sequence data suggest that horizontal gene transfer might have occurred, these events are likely

to have occurred over an evolutionary time scale, i.e., on the order of millions of years ( Brown, 2003 ; Koonin et al., 2001 ; USDA - APHIS, 2010b ) . Third, transgene DNA promoters and coding sequences are optimized for plant expression, not prokaryotic bacterial expression. Thus, even if horizontal gene transfer were to occur, proteins corresponding to the transgenes are not likel y to be produced. Fourth, the FDA has evaluated horizontal gene transfer from the use of antibiotic resistance marker genes, and concluded that the likelihood of transfer of antibiotic resistance genes from plant genomes to microorganisms in the gastrointestinal tract of humans or animals (e.g., E. coli), or in the environment, is remote (US - FDA, 1998 ) . 2.4.4 Microorganisms Soil microorganisms play a key role in soil structure formation, decomposition of organic matter, toxin removal, nutrient cycling, and most biochemical soil processes ( Garbeva et al., 2004 ) .44

They also suppress soil - borne plant diseases and promote plant growth ( Doran e t al., 1996 ) . The main factors affecting microbial population size and diversity include soil ty

pe (texture, structure, organic matter, aggregate stability , pH, and nutrient content), plant ty pe (providers of specific carbon and energy sources into the soil), and agricultural management practices (crop rotation, tillage, herbicide and fertilizer application, and irrigation) ( Garbeva et al., 2004 ) . P lant roots, including those of soy bean , release a variety

of compounds into the soil creating a unique environment for microorganisms in the rhizosphere. Microbial diversity in the rhizosphere may be extensive and differs from the microbial community in the bulk soil ( Garbeva et al., 2004 ) . Members of the bacterial families Rhizobiaceae and Bradyrhizobiaceae form a highl y complex and specific s ymbiotic relationship with leguminous plants, including so yb ean ( Gage, 2004 ) . The nitrogen - fixing plant - microbe s ymbiosis results in the formation of root nodules, providing an environment in which differentiated bacteria called bacteroids are capable of reducing or fixing atmospheric nitrogen. The product of nitrogen fixation, ammonia, then can be used by the plant. In soy

bean, atmospheric nitrogen is fixed into ammonia through a sy mbiotic as sociation with the bacterium Bradyrhizobium japonicum . As a result of this relationship, nitrogen enhancement of soils may onl y be needed in a limited number of situations for maximal yield of soy bean ( Ferguson et al., 2006 ) . It is necessary

that an adequate soil population of nodulation - inducing bacteria be found in the soil planted to soy

bean. As noted in the earlier section on fertilization and effects on air and water, these bacteria must be supplied if a soy bean crop has not been recently grown on the field. Although the bacteria persist for several ye ars in soil, their numbers may not be sufficient to insure adequate nodulation ( Bottomley , 1992 ) . Various commercial sources of inoculants such as multiple strains of Bradyrhizobium can be applied to seeds just before planting, many with similar results ( Beuerlein, 2005 ) . From one season to the next, the inoculated bacteria in soil may change characteristics or phenotypes and diverge from traits expressed by the original culture ( Farooq and Vessey , 2009 ) , and if nodulation is not adequatel y accomplished, growers may need supplemental nitrogen after plant growth has begun ( Ferguson et al., 2006 ) . 2.4.5 Biodiversity Biodiversity

refers to all plants, animals, and microorganisms interacting in an ecos ys tem ( Wilson, 1988 ) . In assessing the plant and animal species of the affected area, the animal and plant sections of this EA named the most common animal species, including mammals, avian species, invertebrates and soil dwelling biota and similarly, plant species that are represented by prominent weeds within the fields and by other non - crop plants at the margins. These are indicators of the overall environment, but do not identify the interaction of all plants, animals, and microorganisms in an ecosystem, which is the definition of biodiversity (Wilson, 1988 ) . Biodiversity

provides valuable genetic resources for crop improvement ( Harlan, 1975 ) and also provides other functions beyond food, fiber, fuel, and income. These include pollination, genetic introgression, biological control, nutrient recycling, compe tition against pests by natural enemies, soil structure, soil and water conservation, disease suppression, control of local microclimate, control of local hydrological processes, and detoxification of noxious chemicals (Alt ieri, 1999 ) . The loss of biodiversity results in a need for costl y management practices in order to provide these functions to the crop (Altieri, 1999 ) .45

The degree of biodiversity in an agroecosystem depends on four primary characteristics: 1) diversity of vegetation within and around the agroecosystem; 2) permanence of various crops within the system; 3) intensity of management; and 4) extent of isolation of the agroecosystem from natural vegetation (Altieri, 1999 ; Palmer et al., 2010 ) . The reintroduction of woodlots, fencerows, hedgerows, wetlands, etc. , has been used to reintroduce biodiversity into large scale monocultures. Other enhancement strategies include intercropping (the planting of two or more crops simultaneously to occupy the same field), agroforestry, crop rotations, cover crops, no tillage, composting, green manuring (growing a crop specifically for the purpose of incorporating it into the soil in order to provide nutrients and organic matter), addition of organic matter (compost, green manure, animal manure, etc.), and hedgerows and windbreaks (Altieri, 1999 ) . Agricultural land subject to intensive farming practices, such as that used in crop production, generally has low levels of biodiversity compared with adjacent natural areas. The use of broad- spectrum insecticides/herbicides is one of the most severe constraints for biological diversity in crops (USDA - APHIS, 2010a) . Tillage, seed bed preparation, planting of a monoculture crop, pesticide use, fertilizer use, and harvest may all limit the diversity of plants and animals (Lovett et al., 2003 ) . Tillage practices may impact biodiversity, and the type of tillage may be dependent upon adoption of a GE herbicide tolerant crop. For example, while production of a non - GE field crop may typically be accomplished using intensive tillage, a GE crop with herbicide tolerance traits may facilitate use of conservation tillage and thus the crop type may lead to the indirect effects observed with planting the GE crop. Thus, comparisons of tillage effects may actually reflect such indirect effects. The majority of soybeans are under some type of conservation tillage (~63% ( CTIC, 2010b ) ); the conservation tillage rates for non- transgenic soybean would likely be substantially less if there were no herbicide tolerance traits facilitating use of this tillage. Weed management with herbicide - tolerant GE crops using over the top herbicides are more efficient than conventional tillage. Tillage alone changes bird species diversity, and in one analysis, four times as many species nested in no - till compared to tilled fields ( Basore et al., 1986 ) . Waste soybean seed left in fields after harvest may in s ome cases be a source of food for birds and other wildlife in fall, winter or spring ( Galle et al., 2009 ) , and may total 48 to 63 kg/ha in untilled crops, and 12 kg/ha in tilled crops (Warner et al., 1985 ) . Species diversity and abundance in soybean agro - ecosystems may differ between the three soybean production methods: conventional with herbicide - tolerant GE varieties (mostly using glyphosate) , conventional with non- GE varieties (using a variety of herbicides) , and organic (without the use of herbicides) . Many studies over the last 10 years have investigated the differences in biological diversity and abundance between GE and non - GE fields, particularly those GE crops that are resistant to insects (e.g., Bt crops) or herbicides (e.g., glyphosate tolerant or glufosinate - tolerant crops.) Different studies have indicated potential decreases in biological diversity or abundance due to GE crops, or the presence of a pesticidal pr otein in some GE crops (Bt) (e.g., (Hansen Jesse and Obrycki, 2000 ; Pilcher et al., 2005 ; Ponsard et al., 2002 ) . Other studies of GE crops, such as Bt corn, when compared to non - GE crops sprayed with insecticides demo nstrate that GE crops do not cause any changes in arthropod abundance or diversity (e.g., ( Bitzer et al., 2005 ; Chen et al., 2008 ; Marvier et al., 2007 ; Romeis et al.,46

2006 ; Torres and Ruberson, 2005 ; Wolfenbarger et al., 2008 ) ). While metastudies have noted an increase in abundances and of some species of organisms in organic crops, one conclusion has been that “positive effects of organic farming on abundance were prominent at the plot and field scales, but not for farms in matched landscapes” (Bengtsson et al., 2005 ) . These authors propose that efforts to enhance biodiversity should be focused on landscapes, not smaller sites such as on fields. Given the small number of organic soybean farms, and that MON 87769 soybean will have no impacts on this production system, comparisons of biodiversity effects of organic and conventional agriculture will not be further analyzed in this EA. Farm - scale comparisons were made of three herbicide tolerant crops with conventionally managed controls

—

beets, winter oilseed rape and maize ( Squire et al., 2003 ) . In two herbicide tolerant crops (beets and winter oilseed rape), weed biomass was significantly reduced over those in the non- GE varieties (Heard et al., 2003 ) . Decreases were detected in invertebrate populations using the weeds as a food source or refuge in the rape and beet herbicide tolerant crops, but not in herbicide tolerant maize (Hawes et al., 2003 ) . As weed biomass was reduced (whether in GE plants or the non - GE control) the herbivores, pollinators and natural enemies generally declined as well ( Buckelew et al., 20 00 ; Hawes et al., 2003 ) . Abundance of yellowhammer and granivore birds was also greater on non- GE than herbicide tolerant beet and rape crops ( Chamberlain et al., 2007 ) , but herbicide tolerant maize also showed the same pattern. Correlating weed diversity and changes in agricultural practices demonstrates that weeds have a broad role in supporting certain types of biological diversity within farmed fields (Marshall et al., 2003 ) . Arthropod abundance may not depend upon c rop 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 N orthern T ier states, and relative to corn and soybean, environments with abundan t crop types and non - crop plants provided greater “biocontrol services” than does extensively planted soybean ( Gardiner et al., 2009 ) . Total insect diversity in GE glyphosate tolerant soybean has been compared to that in non - GE soybean, and although mostly similar, some slight decreases of insect diversity and numbers were observed between rows of GE soybean, but attributed to reduced a bundance of weeds in glyphosate treated plots ( Imura et al., 2010 ) . Buckelew et al. ( Buckelew et al., 2000 ) also conclude that insect abundance in soybean is more related to effectiveness of weed suppression, rather than use of glyphosate herbicide. For some predator insects (biocontrol organisms) on soybean, the genetic diversity of the host soybean is relevant to predicting predator lifespan, and these impacts are not mediated by weeds (Lundgren et al., 2009 ) . Additionally, the comparator chosen may be quite specific to certain relationships, and subtle impacts may be related to use of one specific herbicide (such as Atrazine ) ( Brooks et al., 2005 ) , as was demonstrated in the previous farm scale evaluations (Heard et al., 2003 ) . Soil - inhabiting organisms also respond to changes imposed by constraints of the management sy stem, such as those that include GE gl yphosate tolerant crops. In the case of soil microorganisms, variations in number and species can be observed following many ‘nor mal’ agronomic interventions ( Kowalchuk et al., 2003 ) , but ascertaining those that are relevant to ty pes of production s ys tems require detailed anal ysis. From 10 ye ars of observations, Kremer47

and Means ( Kremer and Means, 2009 ) found increased colo nization by Fusarium of gl yphosate tolerant soy

bean roots following application of gl yphosate, and increases of fluorescent Pseudomonas spp. Kremer and Means ( Kremer and Means, 2009 ) also summarized findings of theirs and others that showed that GE gl yphosate tolerant so ybeans reduced nodulation and nitrogen fixation, but did not affect grain yi elds ( Bohm et al., 2009 ) . However, because many of the variations in soil microbial populations or diversity can be produced b y many types of impacts, Kowalchuk et al. ( Kowalchuk et al., 2003 ) propose that experimentally , s ys tematic anal ys is of indicator groups representing different functions be assessed, and that rigorous methods of anal ys is be required to demonstrate impacts. Since biological diversity can be defined and measured in many way s, APHIS considers determining the level of biological diversity in any crop to be complex and difficult to achieve concurrence. Another complication with biodiversity studies is separating expected impacts from indirect impacts. For example, reductions of biological control organisms are seen in some Bt - expressing GE crops, but are caused b y reduction of the pest host population following transgenic pesticide expression in the transformed crop plant. **2.5 Human**  **Health** 2.5.1 Public Health Public health concerns surrounding GE so ybean primarily involve the human consumption of GE soy bean products. Non - GE soy bean varieties, both those developed for conventional use and for use in organic production sy stems, are not routinely required to be evaluated by any regulatory agency in the U.S. for food safety prior to release in the market. Under the FFDCA, it is the responsibility

of food manufacturers to ensure that the products they market are safe and properl y labeled. Food derived from GE soy bean must be in compliance with all applicable legal and regulatory requirements. GE organisms for food may undergo a voluntary

consultation process with the FDA prior to release onto the market. Although a voluntary process, thus far , all applicants who wish to commercialize a GE variety that will be included in the food suppl y have completed a consultation with the FDA. In a consultation, a developer who intends to commercialize a bioengineered food meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory

issues regarding the bioengineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food . FDA evaluates the submission and responds to the developer b y letter. As noted by

the National Research Council (NRC), unexpected and unintended compositional changes arise with all forms of genetic modification, including both conventional hy bridizing and genetic engineering (NRC, 2004 ) The NRC also noted that at the time, no adverse health effects attributed to genetic engineering had been documented in the human population. Reviews on the nutritional quality of GE foods have generally concluded that there are no significant nutritional differences in non - GE versus GE plants for food or animal feed ( Faust, 2002 ; Flachowsky et al., 2005 ) .48

Monsanto has provided the FDA with information on the identity , function, and characterization of the genes, including expression of the gene products. The submittal to the FDA included information on the safety of the altered fatty acid profile in MON 87769 soy bean oil, including a dietary risk assessment. Monsanto initiated the consultation process with FDA for the commercial distribution of MON 87769 and submitted a safety and nutritional assessment of food and feed derived from MON 87769 to the FDA on March 23, 2009 (BNF No. 00117). FDA is currentl y evaluating the submission ( Monsanto, 2010b ) . SDA soy bean has been accepted as GRAS (GRN No. 000 283) after FDA accepted the notice in September 2009 (US - FDA, 2009a) ; SDA is to be used as an ingredient in baked goods and baking mixes, breakfast cereals and grai ns, cheeses, dairy

product analogs, fats and oils, and so forth that will have 375 mg of stearidonic so ybean oil per serving ( US - FDA, 2009b ) . 2.5.2 Human Dietary Health Soy bean protein is used in food production to enhance nutrition and also to supply functional properties. In breakfast cereals and pasta, it enhances protein content (United Soybean Board, 2009). In baked goods, soups, meats and poultry it may emu lsify , absorb fats and water, provide adhesion or cohesion properties, and in many other products it may aerate, add texture, assist in film or dough formation, increase shelf life and improve richness. Besides uses of soy bean for functional properties, o ther foods are predominantly soy , such as so y beverages, tofu, textured vegetable protein items (simulated meats), such as burgers, hot dogs, crumbles, nuggets, green vegetable so ybeans (edamame), and so y flour as a primary constituent of many

foods and numerous other products (USB, 2011c ) . Soy bean oil achiev ed prominence as a food oil after cottonseed oil and lard were overtaken in the 1950s and by

2000, and soy

bean oil was found in almost 61% of the liquid oils, margarines, and shortening b y 2000 ( O'Brien, 2004 ) . Thus, soy bean oil is the principal food oil used in the U . S. The oil has high vers atility for food processing and formulating, because it can be processed with low losses, and is high in essential fatty acids ( O'Brien, 2004 ) . **Table 9. Percentages of linoleic and linolenic acid in various vegetable oil sources and**

**U.S. consumption. Oil type**  **Linolenic a**  **cid**

**as % fatty acid** 

**- typical value**  **of omega**  **- 3**  **Linoleic a**  **cid**

**as % fatty acid** 

**- typical value**  **of omega**  **- 6**  **U.S.**

**c onsumption**  **2000 (m**  **illions pounds)**  S oy bean 7.6 53.7 16,210 C anola 8.8 21.0 1,744 Canola - High Oleic* 3 14 NA C orn 1.2 59.6 1,711 Sunflower* <1 65 --49

C oconut 0.0 1.6 968 C ottonseed 0.7 54.4 674 P alm 0.4 10.1 375 Sources: ( O'Brien, 2004 ) and * ( Orthoefer, 2005 ) . Soy bean contains two apparentl y essential pol yunsaturated fatty acids , an omega - 3 (linolenic: C18:3) and an omega - 6 (linoleic: C18:2) , in appreciable quantities. Another principle fatty acid constituent is the monounsaturated fatty acid, oleic acid (C18:1). Two other principle fatty acids include saturated ones, stearic (C18) and palmitic (C16). DHA (22:6 n - 4) and EPA (20:5 n - 3) are highl y beneficial fatty acids that may support good human health or correct health concerns, but are not represented in soy oil. In a review of the literature, Wijendran and Hayes ( Wijendran and Hayes, 2004 ) showed that DHA and EPA are important contributors to good cardiovascular health. Additional benefits may include preventing aging - related cogniti ve decline according to Cunnane et al. ( Cunnane et al., 2009 ) . Hamer et al. ( Hamer et al., 2005 ) summarized additional evidence that these fatty acids when added to the diet may

improve health st atus for other conditions as well. The omega - 3 oil, linolenic acid, can be metabolized by human biosy

nthetic processes to the fatty acids EPA and DHA , but not at sufficiently high rates to provide what may be healthful intake levels of the desirable EPA an d DHA ( Burdge and Calder, 2005 ) . The biosy nthesis of SDA to EPA in humans has been studied, and it is far more efficient than biosy nthesis of EPA from alpha linolenic acid, a ty pical so ybean fatty acid. Thus, James et al. ( James et al., 2003 ) showed that if the incorporation of EPA into ery throcy tes and plasma was assigned a value of 1.0, EPA incorporation fol lowing SDA administration occurred with an efficiency of 0.3, and incorporation following alpha linolenic acid (soy bean constituent), 0.07. To attain recommended intake rates of EPA, populations should consume 1.5 g/day of SDA. These levels could be achi eved if all ty pical vegetable oils consumed, including cooking oil, margarine, salad oil and mayonnaise contained about 10% SDA ( James et al., 2003 ) . While fish oils are a practical source o f EPA and DHA for human health, omega - 3 fatty acids from vegetable sources are an ecologicall y sustainable alternative. This source relies on conversion of SDA by

human metabolism into the healthful fatty acids. Sourcing these fatty acids from so ybean spares fish which may be in reduced suppl y because of overfishing of resources in world oceans. About 80% of the market for food and supplement use of omega - 3 fatty acids is provided by fish oils (Packaged Facts (Market Research Group LLC), cited in ( Daniells, 2011 ) ). Krill are also rich in EPA and DHA (some species with around 30% of these as a percentage of fatty

acids (L inder et al, 2010) and are becoming an increasing source of these highl y unsaturated fatty acids ( Starling, 2011 ) . EPA and DHA are also produced by yeast such as Yarrowia lipolytica , a species which also synthesizes food gr ade citric acid ( Du Pont, 2011 ) . Algae produced in contained ponds are currently a source of DHA and other fatty acids in foods and supplements ( Martek, 2010 ) . SDA is an infrequent fatty acid in plants, but may

be found in up to 14% concentrations in Ribes nigrum , and Primula and Echium species (Aitzetmüller and W erner, 1991 ) . Soy

bean is one of the most economical oil sources, and development of these other plants as a SDA source would not be an option to be taken over a short term, nor likely to produce inexpensive specialty oil. In the U . S . , the market for ome ga - 3 fatty acids for functional50

foods is $4 billion and for supplements is $1.3 billion (Packaged Facts (Market Research Group LLC), cited in ( Daniells, 2011 ) ). One issue that is relevant to human health is the more rapid oxidation of SDA and other poly unsaturated 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 aldeh ydes, and the production of off - flavors ( Jacobsen et al., 2008 ) . However, the stability of SDA can be improved b y formulation with appropriate antioxidants (see review in ( Jacobsen et al., 2008 ) ). One such example is the use of citric acid which provided stability to SDA that was similar to that of oleic acid when subjected to 55 and 25 degree heat protocols and then fatty acid anal ys is (Appendix B - 2 ( Monsanto, 2009 ) ). T he 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 sunf lower, canola, safflower and so ybean), is noted b y Dubois et al. ( Dubois et al., 2007 ) ; these changes may have consequences for human health (see also Table 9 for omega - 3 content in common vegetable oils) . The need of food manufacturers for products with reduced linolenic acid has been met b y either new sources of oils (reduced linolenic acid varieties in soybean) or trans hydrogenation (whi ch destroy s linolenic acid). Although these strategies increase oxidative stability and thus shelf

- life (desirable properties for merchandising products containing oils) , future trend s may

not provide for current content of omega - 3 fatty acids in human di ets, as recommended b y multiple nutrition authorities (University of Connecticut, 2011 ) . The essential fatty acid, linolenic acid, should continue to be available in food products to enhance content of healthful DHA and EPA and the longer chain fatty acids, rather than be reduced ( Dubois et al., 2007 ) ; replacement with another omega - 3 fatty acid such as stearidonic may be a useful dietary direction . At present, U.S. National Academ y of Sciences (NAS) has not discerned any deficits in cur rent U.S. dietary

intake. NAS /Institute of Medicine advises an Acceptable Macronutrient Distribution Range (AMDR) of omega - 3 pol yunsaturated fatty acids as 0.6 to 1.2% of dietary energy , and ratios of omega - 6 to omega - 3 fatty acids between 5.1 and 10.1 fo r adults ( Otten et al., 2006 ) . These AMDRs are based on average cons umption values for U . S . consumers, and there is no known deficiency of omega - 3s in this population. 2.5.3 Worker Safety Worker hazards in farming are common to all typ es of agricultural production, and include hazards of equipment, exposures to agricultural chem icals, and to plant materials. Production of soy bean exposes workers to herbicides, and acceptable exposures are regulated by U.S. EPA labels. EPA’s Worker Protection Standard (WPS) (40 CFR part 170) was published in 1992 requiring actions to reduce the risk of pesticide poisonings and injuries among agricultural workers and pesticide handlers. The WPS offers protection to more than two and a half million agricultural workers who work with pesticides at more than 560,000 workplaces on farms, forests, nur series, and greenhouses. The WPS contains requirements for pesticide safety training, notification of pesticide applications, use of personal protective equipment, restricted entry intervals following pesticide application, decontamination supplies, and e mergency medical assistance.5 1

Grower compliance with all U.S. EPA requirements is required. MON 87769 soy bean has no added herbicide tolerance, so its cultivation would be similar to that of non - herbicide tolerant soy bean. None of the agricultural chemicals that would be used with MON 87769 soy bean differ from those used with other ty pical commercial soy

bean varieties. Although an allergenic potential of soy

bean exists, soy

bean allergy

is typically a response to ingestion. Hull hy persensitivity

following inhalation has been observed, as have asthma reactions of workers to soy bean dust ( Besler et al., 2000 ) . Oils produced by soy bean are typical of those produced b y many other plants and are generally not allergenic ( Hefle and Taylor, 1999 ) , but rather are required human dietary

constitu ents. **2.6 Animal Feed**  Animal feed concerns surrounding GE so ybean primarily involve the animal consumption of GE soy bean products. Soy

bean meal is a substantial part of animal feed rations in the U . S. In 2009, approximately

39 million tons of soy

bean meal wa s produced, 27 million tons of which was marketed for animal feed, with the largest volumes consumed by poultry (48%), swine (26%), and beef (12%) ( Soy Stats, 2010c , 2010e ) . Non - GE so ybean varieties, both those developed for conventional use and for use in organic production sy stems, are not routinely required to be evaluated by any regulatory

agency in the U.S. for feed safety

prior to release in the m arket. Under the FFDCA, it is the responsibility of feed manufacturers to ensure that the products they market are safe and properly labeled. Feed derived from GE so ybean must be in compliance with all applicable legal and regulatory requirements. GE or ganisms for feed may undergo a voluntary

consultation process with the FDA prior to release onto the market. Although a voluntary

process, thus far all applicants who wish to commercialize a GE variety that will be included in the food supply have complete d a consultation with the FDA. In a consultation, a developer who intends to commercialize a bioengineered food meets with the agency to identify

and discuss relevant safety, nutritional, or other regulatory issues regarding the bioengineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food. FDA evaluates the submission and responds to the developer b y letter. Monsanto has provided the FDA with information on the identity , function, and characterization of the genes, including expression of the gene products in MON 87769 soybean . The submittal to the FDA included information on the safety of the SDA and profile of other fatty acids in MON 87769 soy

bean oil, including a dietary risk assessment. Monsanto initiated the consultation process with FDA for the commercial distribution of MON 87769 soy bean and submitted a safety and nutritional assessment of food and feed derived from MON 87769 soy bean to the FDA on March 23, 2009 (BNF No. 00117) ( Monsanto, 2010b ) . FDA is currentl y evaluating the submission. **2.7 Socioeconomic**  2.7.1 Domestic Economic Environment Soy bean first entered North America in the 18th century ( Hoeft et al., 2000 ) . Sometime during the 1930s, soy

bean was processed industriall y in the U.S. for edible oil and protein meal.52

Currently , the U.S. produces approximately 38% of the global soy

bean supply ( Soy Stats, 2010h) . In 2009, the U.S. exported 1.3 billion bushels (34.9 million metric tons) of soy bean, which accounted for 46% of the world's so yb ean exports ( Soy Stats, 2010g ) . In total, the U.S. exported $16.5 billion worth of soybean and so yb ean products globall y in 2009 ( Soy Stats, 2010b ) . China is the largest export market for U.S. so ybean with purchases totaling $9.2 billion. Mexico is the second largest export market with sales of $1.3 billion in the same year ( Soy Stats, 2010 b ) . Other significant markets include Japan and the EU. Soy bean Production Operating Costs Managing production costs is a major component to the economics of producing a so ybean crop. Key cost decisions include the choice of which soy bean varieties to plant, the amount of fertilizer to apply , and which herbicide program to use. The average operating cost for producing soy bean in the U.S. in 2006 was $93.41 per acre, with the value of the production less operating cost reported to be $161.43 per acre ( USDA - ERS, 2006b ) . Soy bean Products Soy meal typicall y contains about 50% protein b y dry weight, and is the most important product of soy bean production. From production and feeding statistics, in 2010 about 67% of the domestic - crushed so yb ean meal was fed to domestic animals, and 28% of the meal was exported (most likely

for animal feed in the international market) ( ( So yS tats, 2011b ) ; Table 8, 2009/2010 (USDA - FAS, 2011 ) ). Of the domestically crushed soy

bean, 53% of so yb ean by weight produces meal and 19% produces oil ( Soy Stats, 2011b ) . Thus, o nly a small proportion of the soy bean crop is consumed directly b y humans. Human food derives from whole soybean made into soy milk (including tofu), or from meal processed into soy flour (meat substitutes) or into isolates or concentrates (protein powder) or from processed whole soy beans (soy

nuts) or from fresh soy beans (edamame) ( Soyconnection, 2011 ) . The domestic food use of soy bean oil is mainly

in frying oils, salad and cooking oils, and margarines ( Soy Stats, 2010d) . In 2009, these three categories represented approximately 85% of the soy

bean oil market in the U.S., with industrial uses consuming the remaining 15% ( Soy Stats, 2010d ; USSEC, 2006 ) . Soy bean oil industrial uses include plastics, lubricants, coatings, printing inks and adhesives, emulsifiers, surfactants (industrial detergents and cleaners as well as solvents), resins, and biodiesel, among others (AGRA, 2009 ; USB, 2010b ) . Soy- based industrial oil products have many advantages in the marketplace, including being inherentl y biodegradable, having low ecotoxicity , and being derived from renewable resources (USSEC, 2006 ) . The extraction of oil from soy beans also creates a highl y valued solid, soybean meal, which is used for animal food in all sectors (swine, beef, poultry , dairy

and fish). Prices for so ybean oil typically are among the lowest among those for all vegetable oils. During the 10 - ye ar period 1996 - 2006 three months out of 12, only Malay palm oil prices we re lower than U . S . sourced so ybean oil (USDA - FAS, 2008 ) . Duri ng the 12 - month period October September 2006/2007 corn oil prices were lower than soy bean oil prices in only

five months during the same period ( USDA - FAS, 2008 ) Thus, both low cost and usability have led to soy bean oil becoming the top choice of food processors and industrial processors for feedstock in these industries.53

Changes in fatty

acid profile may

impact food and industrial uses of the soybean oil. Fatty acid composition of the soy

bean oil affects melting point, oxidative stability, and chemical functionality , and changes in any of these can impact the mar ket sector of the product (APAG, 2011 ) . Table 10 illustrates several of the key physical properties of the fatty acid constituents of soy bean oil. **Table 10.**  **Properties of s**  **elect f**  **atty a**  **cids .**  **Fatty Acid Fatty Acid** 

**Lipid Number**  **1 Saturated**  **Unsaturated Melting**  **Point (oC) Boiling** 

**Point (oC)** Palmitic a cid C16 X 62.9 167 Stearic a cid C18 X 70 361.6 Oleic a cid C18:1 X 14 286 Linoleic a cid C18:2 X - 5 228 Linolenic a cid C18 - 3 X - 11 230 Source: ( CRC, 2011 ) 1. As in Ta

ble 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 pol yunsaturated f atty acids, containing 2 and 3 double bonds, respectivel y ( Institute of Shortening and Edible Oils, 2006 ) . Generally , the long er the carbon chains for saturated fatty acids, the higher the melting point, and the more unsaturated, the lower the melting point ( Berg et al., 2002 ) . These fatty acid properties influence the market applications for the oil, and various foods and industrial products are formulated to take these properties into consideration. Many of the commercial vegetable oils are a carefull y blended mix to take advantage of the properties of the constituent fatty

acids ( Cargill, 2011 ) . A so y oil with a high content of oleic acid and low content of poly

unsaturated fatty

acids results in an oil with high oxidative stability , a critical property for industrial lubricants, as well as achieving the food industry needs for a so y- based oil without trans fatty

acids ( Cahoon, 2003 ; Soyconnection, 2011 ) . Soy bean Industry

Description Soy bean industry

comprises two main groups, commodity production businesses and the users of soy bean products. The commodity production business begins with the providers and developers of the traits technology and the seed, retailers that sell seed to growers, the growers and their operations. Users of the so ybean commodity include those who purchase the soy bean seed and then crush, process and sell the basic products of seed, oil and meal, to the next set of soy bean processors or users. The downstream purchasers are animal feed producers, food54

producers, oil users in food and industrial sectors, and industrial product manufacturers, such as those for biodiesel oil. Commodity

Production Industry Contracts are typically signed with growers when the speci alty seed is purchased, obligating the growers to suppl y harvested seed under given conditions, such as all the soybean from a certain number of committed acres, specifying methods of productions and where the seed may be sold, and establishing standards f or the product when delivered. Contracts between the growers and an oil crusher may

be 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 so yb ean seed for commodity or IP use, two industries are relevant. The first are businesses that sell seed for planting and applied chemicals, and the second are the buye rs of soy bean grain, the elevators. Bo th are needed to produce specialty soy products. When a grower purchases specialty seeds, he will be required to produce his soybeans for a designated elevator, and a contract with the elevator may specify means of production, crop performance and seed qu ality . Soy bean meal is the most important product deriving from soy bean seed and meal is the product that drives demand for soybean rather than oil. Oil comprises only 19% b y weight of the soy bean ( Ty son et al., 2004 ) . Thus, oil is a minor product of the crushing industry . As noted earlier, so yb ean meal is predominantly fed to animals while a small percentage is used for human consumption or industrial uses (see preceding section on “Soy bean Products”). Fatty acid composition of soy be an oil is affected by

many variables, including genetics of the crop, details of the climate including temperature, available water and timing of applied water, and probabl y other facts about the planting site, including soil components ( Lee and Herbek, 2004 ; Oliva et al., 2006 ; Primomo et al., 2002 ) . Consequently , a range of values for so ybean oil can be distinguished in soy bean varieties planted in the U . S. See Table 1 for these ranges and a ty pical value found in a general textbook about U . S . oils. Animal Feed Users Animal feeds are the major use for so yb ean meal, consuming about 77% of the total meal produced (2007/2008 (USB, 2011a) ). Oil from soy bean 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 formulat ed with soy bean meal. In 2008/2009, 10.3 million metric tons of meal was used in broiler rations, 9.1 million tons in hog rations and 1.9 million tons in beef rations (USB, 2010a ) . The other animal industries used 7.7 million tons for feeding operations. A variety of industries prepares, formulates, manufactures and distributes animal feeds. Fresh and Processed Food Users Various industries supply all ty pes of processed and fresh foods deriving from soy bean (USB, 2011c ) . Grain products from soy include flours, pasta, bread, waffles, and cereal. Oil products include margarines, salad and frying oils. Simulated ‘meats’ include soy burgers, hot dogs,55

nuggets, and tofu. Vegetable uses include edamame, and so ynuts. Simulated ‘milk products’ include soy

milk beverage, soy

cheese, yoghurt, and ice cre am. Oil Users In the production of oils from oilseed such as so ybean, two general industries can be identified ( O'Brien, 2004 ) . The first is the crusher/refiner whose focus may be oil feedstocks deriving from a single source of oilseed, and which processes the oil in a continuous, automated mo de. The crushing business, which extracts crude vegetable oil and meal, sends the oil to refiners, or may retain some for industrial and fuel users. The refiners may be separate physically

from the crushing business and may subject oil to including degumming, refining, bleaching, dewaxing, fractionating, interesterifying, hydrogenating, changing the melting points of the oil, blending and deodorizing. The refiner may then package the liquid oil, produce margarines, shortening, and bulk fats or oils. In 2007, soy bean receipts at oil crushing facilities attained to 54.4 million tons, with slightly

more crushed than originating from receipts (US Census Bureau, 2008 ) . Specialty oils when produced at facilities making commodity oils are produc ed in batches or only semi continuously

and supply

specialized needs of the food processing or other commercial products industries. The total value of products from the primary soy bean processing industry were estimated at $18 billion (US Census Bureau, 2009a) . The second industry

comprises the many

value - added businesses which may employ starting feedstocks from soy seed or other oilseed sources, and which manufacture products from commodity

oil or a variety

of specialized oils. These include food and industrial product manufacturers in a wide variety of offeri ngs to businesses, retailers and consumers. Foods The properties of oils that are used in foods may vary widel y, and these result from the fatty acids that are incorporated into constituent triglycerides. The positions of the fatty acids within the trigl yc erides also may help determine these properties. Specific fatty acids have associated chemical properties (such as reactivity) and phy sical properties (such as melting points), as well as other functional properties which are taken into account when they are incorporated into foods. Oils high in unsaturated fatty acids (5 - 15%. such as those derived from hydrogenated soy bean oil, stearin fractions of palm oil, etc.) are useful in making solid fat products such as baking shortenings ( O'Brien, 2009a) , while oils low in saturated fats (and optimally, high in oleic acid) are useful for salad oils ( O'Brien, 2009b ) . Trans - esterification may be used to change the positions of the fatty

acids in the trigl yceride, or exchange one for another, all of which can alter oil properties. When fatty

acids are oxidized, flavor is adversel y affected, and this is referred to as “reverted” oil. Reverted soy

bean oil has a “beany” or “grassy” flavor ( O'Brien, 2004 ) . Oils that are high in poly unsaturates are the most susceptible to such oxidation among food oils. L inoleic and particularl y linolenic in traditional soybean oil are those fatty acids most easily oxidized. Hydrogenation of soy

bean salad oils reduces the content of linolenic acid, a poly unsaturated oil, and ty pically , will reduce it from 9% to 3% ( O'Brien, 2004 ) . Reducing the unsaturated linolenic acid decreases the possibility that off - flavors will develop. This process also produces “trans”56

fatty acids, which have be en linked to deleterious consequences for human health, and have encouraged the development of other so ybean lines with altered fatty acid content. Industrial (Non - Edible Products) Use Soy bean oil is a feed stock for numerous products used in several dome stic industries. Biodiesel provides the largest market for so ybean oil ( see Table 11), with production at 8 22 ,000 metric tons in 2008/2009 (USB, 2011b ) . Soy bean biodiesel in 2007 had a value of $1.09 billion dollars. By comp arison, fuel ethanol had a value of $6.6 billion (US Census Bureau, 2009a). S oaps, amines, f atty a cids and o leo c hemicals is the second largest consumer of industrial soy bean oil at 1 40 ,000 metric tons ( see Table 11 ) (USB, 2011b ) . Paints, coatings and inks rank third, with 118,000 metric tons, and p olyols and p lastics with 115,000 metric tons. Lu bricants and w orking f luids produced a total 26,000 metric tons, and solvents and s pecialty uses a total of 22,000 tons. A total of 15 .8 billion pounds of refined so yb ean oil was processed in the U.S. in 2008 (US Census Bureau, 2009b ) . **Table 11**  **. Industrial soybean oil production 2008/2009.**  **Product Soybean oil**  **( m**  **illion m**  **etric t**  **ons)** Biodiesel 0.8 22 Soaps, Amines, Fatty Acids & Oleo Chemicals 0.1 40 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 o f soy bean are the U.S., Brazil, Argentina, China, and India, which accounted for approximately 91% of the global soy

bean production in 2007 ( Soyatech, 2010 ) (see Table 12). So ybeans produced in China and India are primaril y for domestic use. A signifi cant portion of so ybean produced in the U.S., Brazil, and Argentina is traded globall y in the form of so ybean harvested seed, so yb ean meal, or soy bean oil ( Monsanto, 2010b ) . Globally , the U.S. was the largest soy bean seed export country ; whereas Argentina led the soy b ean meal and soy bean oil export markets in 2007 ( Soyatech, 2010 ) .57 **Table 12.**  **World s**  **oybean p**  **roduction ,**  **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 soy beans in 2007, down from 511,000 in 1982 (USDA - ERS, 2010d; USDA -NASS, 2007). Soy bean farms with sales greater than $50,000 totaled 109, 269 (USDA -NASS, 2007). Although acreage planted to soy

beans was also lower in 2007 than in 2002 as growers s hifted to corn production, harvested so yb ean acreage per farm increased from 114 acres in 1978 to 229 acres in 2007 (USDA - ERS, 2010d). Although small farms with less than 250 acres accounted for 72% of the farms growing so ybeans, these farms produced only 26% of the 2007 crop (USDA - ERS, 2010d). Irrigation was used on 5.2 million acres of soy bean, or 8% of U.S. so ybean acreage in 2007 (USDA - ERS, 2010d). Individual or family farms accounted for 81% of all soy bean farms in 2007 and 69% of so ybean production , with the balance identified largel y as partnerships and small family- held corporations; corporations accounted for less than 1% of soy bean farms and soy bean production (USDA - ERS, 2010d). Farms which specialized in soy bean production have been reported as generally smaller in terms of farm size and sales than farms which do not specialize in soy bean cultivation (USDA - ERS, 2006b). Operators of many of the farms which specialize in soy bean cultivation have reported non - farm incomes. Fewer than half of the growers specializing in soy bean 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 so yb ean farms is reported as approximately 623 acres; whereas, the average acreage of a more specialized so ybean farm operator is reported at 390 acres (USDA - ERS, 2006b). Nearl y 60% of these specialty soy bean farmers reporte d annual income58

less than $40,000; whereas, 76% of commodity soy bean farmers reported incomes exceeding $40,000 per ye ar (USDA - ERS, 2006b). Industrial so yb ean crushers, as represented b y m embership in the National Oilseed Processors Association (which in cludes 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 soy bean. For soy

bean blending and refining, the U.S. Census Bureau (US Census Bureau, 2007 ) noted that these operations employ 6,019 people with a total value of products of $19.2 billion. Statistics for other parts of the soy bean industry

are included in summaries for other oil products; additional details of soy

bean businesses from these Census Bureau statistics thus cannot be distinguished. To provide perspective about one soy bean processor (South Dakota Soy bean Processors), this business is a cooperative with 2,200 farmer/members. This crushing/refining business produces refined and bleached so y oil for industrial buyers, so ybean meal and hulls and also partly

owns an ancillary

urethane/resin business The crusher processes 3 0 million bushels of soy bean per year and has 83 employees ( Hoover's, 2011 ) . About 1.3 million metric tons of soy bean derived non - food p roducts were produced in 2009 (see Table 11 ). APHIS is not aware of data for the numbers of emplo yees engaged in various industrial production sectors using so ybean products. However, the largest category of industrial products, biodiesel, was estimated in 2009 to include 1700 manufacturing employees and 160 agricultural workers that were needed to suppl y the commodity soy bean ( Cardnoentrix, 2011 ) . The same report identified a total of 21,000 jobs as d eriving from 2009 biodiesel production. Food production involving so ybean products has reached $4.5 billion in 2009 ( SANA, 2011download) and total employ ment in this industry

is not readily

available.59

**3 ALTERNATIVES**  This document anal yz es the potential environmental consequences of a determination of nonregulated status of MON 87769 soy bean . To respond favorabl y to a petition for nonregulated status, APHI S must determine that MON 87769 soybean is unlikely to pose a plant pest risk. Based on its PPRA (USDA - APHIS, 2010c ) , APHIS has concluded that MON 87769 soy bean is unlikely to pose a plant pest risk. Therefore APHIS must determine that MON 87769 soy bean is no longer subject to 7 CFR part 3 40 or the plant pest provisions of the Plant Protection Act. Two alternatives are evaluated in this EA: (1) no action and (2) determination of nonregulated status of MON 87769 soybean . APHIS has assessed the potential for environmental impacts for each alternative in the Environmental Consequences section. **3.1 No Action Alternative: Continuation as a Regulated Article**  Under the No Action Alternative, APHIS would deny the petition. MON 87769 soy bean and progeny derived from MON 87769 soy bean would continue to be regulated articles under the regulations at 7 CFR p art 340 . Permits issued or notifications acknowledged by APHIS would still be required for introductions of MON 87769 soy bean and m easures to ensure ph ys ical and reproductive confinement would continue to be implemented. APHI S might choose this alternative if there were insufficient evidence to demonstrate the lack of plant pest risk from the unconfined cultivation of MON 87769 soy be an . This alternative is not the Preferred Alternative because APHIS has concluded through a PPRA that MON 87769 soy

bean is unlikely

to pose a plant pest risk (USDA - APHIS, 2010c ) . Choosing this alternative would not satisfy the purpose and need of making a determination of plant pest risk status and responding to the petition for nonregulated status. **3.2 Preferred Alternative: Determination that MON 87769 Soybean is No Longer a**  **Regulated Article** Under this alternative, MON 87769 soy bean and progeny derived from them would no longer be regulated articles under the regulations at 7 CFR part 340 . MON 87769 soy bean is unlikely

to pose a plant pest risk (USDA - APHI S, 2010c ) . Permits issued or notifications acknowledged b y APHI S would no longer be required for introductions of MON 87769 so yb ean and proge ny derived from this event . This alternative best meets the purpose and need to respond appropriatel y to a petition for nonregulated status based on the requirements in 7 CFR part 340 and the agency ’s authority under the plant pest provisions of the Plant Protection Act. Because the agency

has concluded that MON 87769 soy bean is unlikely

to pose a plant pest risk, a determination of nonregulated status of MON 87769 soy bean is a response that is consistent with the plant pest provisions of the PPA, the regulations codified in 7 CFR part 340, and the biotechnology

regulatory policies in the Coordinated Framework. Under this alternative, growers may have future access to MON 87769 so ybean and progeny derived from this event if the developer decides to commerci alize MON 87769 soy bean .60

**3.3 Alternatives Considered But Rejected from Further Consideration**  APHI S assembled a list of alternatives that might be considered for MON 87769 soy bean . The agency evaluated these alternatives, in light of the agency's authority und er the plant pest provisions of the Plant Protection Act, and the regulations at 7 CFR part 340, with respect to environmental safety , efficacy , and practicality to identify

which alternatives would be further considered for MON 87769 soy bean . Based on th is evaluation, APHI S rejected several alternatives. These alternatives are discussed briefly below along with the specific reasons for rejecting each. 3.3.1 Prohibit Any

MON 87769 from Being Released In response to public comments that stated a preference that no GE organisms enter the marketplace, APHIS considered prohibiting the release of MON 87769 soybean , including denying any

permits associated with the field testing. APHIS determined that this alternative is not appropriate given that APHI S has concluded that MON 87769 soy bean is unlikely

to pose a plant pest risk (USDA - APHI S, 2010c ) . In enacting the Plant Protection Act, Congress found that [D]ecisions affecting imports, exports, and interstate movement of products regulated under [the Plant Protection Act] shall be based on sound science...§ 402(4). On March 11, 2011, in a Memorandum for the Heads of Executive Departments and Agencies, the White House Emerging Technologies Interagency Policy Coordination Committee developed broad principles, consistent with Executive Order 13563, to guide the development and implementation of policies for oversight of emerging technologies (such as genetic engineering) at the agency

level. In accordance with this memorandum, agencies should adhere to Executive Order 13563 and, consistent with that Executive Order, the fo llowing principle, among others, to the extent permitted by

law, when regulating emerging technologies: “[D]ecisions should be based on the best reasonably obtainable scientific, technical, economic, and other information, within the boundaries of the authorities and mandates of each agency” Based on the PPRA (USDA - APHIS 2011) and the scientific data evaluated therein, APHIS concluded that MON 87769 soy bean is unlikely

to pose a plant pest risk. Accordingl y, there is no basis in science for prohibiting the release of MON 87769 soy bean . 3.3.2 Approve the Petition in Part The regulations at 7 CFR 340.6(d)(3)(i) state that APHI S may "approve the petition in whole or in part." For example, a determination of nonregulated status in part may be appropriate if there is a plant pest risk associated with some, but not all lines described in a petition. Because APHIS has concluded that MON 87769 soy bean is unlikely

to pose a plant pest risk (USDA - APHIS, 2010c ) , there is no regulatory basis under the plant pest provisions of the Plant Protection Act for considering approval of the petition only in part.61

3.3.3 Isolation Distance between MON 87769 Soy bean and Non - GE Soy

bean Production and Geographical Restrictions In response to public concerns of gene movement between GE and non - GE plants, APHI S considered requiring an isol ation distance separating MON 87769 so yb ean from non - GE soy bean production. However, because APHIS has concluded that MON 87769 soy bean is unlikely to pose a plant pest risk (USDA - APHIS, 2010c ) , an alternative based on requiring isolation distances would be inconsistent with the statutory authority under the plant pest provisions of the Plant Protection Act and regulations in 7 CFR part 340. APHI S also considered geographically restricting the production of MON 87769 soy bean based on the location of production of non - GE soy bean in organic production sy ste ms in response to public concerns regarding possible gene movement between GE and non - GE plants. However, as presented in APHI S’ PPRA for MON 87769 soybean, there are no geographic differences associated with any identifiable plant pest risks for MON 8776 9 soy bean ( USDA - APHI S, 2010c ) . This alternative w as rejected and not analyzed in detail because APHI S has concluded that MON 87769 soy

bean does not pose a plant pest risk, and will not exhibit a greater plant pest risk in any

geographically

restricted area. Therefore, such an alternative would not be co nsistent with APHI S’ statutory

authority under the plant pest provisions of the Plant Protection Act and regulations in Part 340 and the biotechnology regulatory

policies embodied in the Coordinated Framework. Based on the foregoing, the imposition of isol ation distances or geographic restrictions would not meet APHI S’ purpose and need to respond appropriately to a petition for nonregulated status based on the requirements in 7 CFR part 340 and the agency ’s authority under the plant pest provisions of the P lant Protection Act. However, i ndividuals might choose on their own to geographically

isolate their non - GE soy

bean production sy stems from MON 87769 soy bean or to use isolation distances and other management practices to minimize gene movement between soy bean fields . In formation to assist growers in making informed management decisions for MON 87769 soy

bean is available from Association of Official Seed Certifying Agencies (AOSCA, 2010 ) . 3.3.4 Requirement of Testing for MON 87769 Soy bean During the comment periods for other petitions for nonregulated status, some commenters requested USDA to require and provide testing for GE products in non - GE production sy stems. APHI S notes there are no natio nally- established regulations involving testing, criteria, or limits of GE material in non - GE sy stems. Such a requirement would be extremely difficult to implement and maintain. Additionally , because MON 87769 soy bean does not pose a plant pest risk (USDA - APHIS, 2010c ) , the imposition of any ty pe of tes ting requirements is inconsistent with the plant pest provisions of the Plant Protection Act, the regulations at 7 CFR part 340 and biotechnology

regulatory policies embodied in the Coordinated Framework. Therefore, imposing such a requirement for MON 877 69 soy bean would not meet APHI S’ purpose and need to respond appropriately to the petition in accordance with its regulatory authorities.62

**3.4 Comparison of Alternatives**  Table 13 presents a summary of the potential impacts associated with selection of either of the alternatives evaluated in this EA. The impact assessment is presented in Section 4 of this EA. **Table 13**  **. Summary of issues of potential impacts and consequences of alternatives. Attribute/Measure**  **Alternative A: No Action**  **Alternative B: Determination**  **of Nonregulated Status**  Meets Purpose and Need and Objectives No Yes Unlikely to pose a plant pest risk Satisfied through use of regulated field trials Satisfied

– PPRA ( USDA APHIS, 2010c ) **Management Practices** Acreage and Areas of Soybean Production Unchanged Unchanged Seed Production Unchanged Unchanged Organic Farming Unchanged Unchanged Specialty Soybean Unchanged Unchanged Soybean Cultivation Practices Unchanged Unchanged **Physical Environment**  Water Resources Unchanged Unchanged Soil and Land Use Unchanged Unchanged Air Quality Unchanged Unchanged Climate Change Unchanged Unchanged **Biological Resources** Gene Movement and Weediness Unchanged Unchanged Animals Unchanged Unchanged Plants Unchanged Unchanged63

**Attribute/Measure Alternative A:**  **No Action Alternative B:**  **Determination of**  **Nonregulated Status** Microorganisms Unchanged Unchanged Biological Diversity Unchanged Unchanged **Human and Animal Health** Worker Safety Unchanged Unchanged Risk to Human Health Unchanged Unchanged (potential health benefits ) Risk to Animal Feed Unchanged Unchanged **Socioeconomic** Domestic Economic Environment Unchanged Unchanged Trade Economic Environment Unchanged Unchanged **Other Regulatory Approvals** Other U.S Regulatory Approvals Unchanged for existing nonregulated GE organisms FDA consultation pending, U.S. EPA tolerance exemptions and conditional pesticide registrations not required. **Compliance with Other Laws** CWA, CAA, EOs Fully compliant Fully compliant Notes: 1. Unchanged

– the current conditions will not change as a result of the selection of this alternative.64

**4 ENVIRONMENTAL CONSEQ**  **UENCES** This analy sis of potential environmental consequences addresses the potential impact to the human environment from the alternatives anal yz ed in this EA, namely taking no action and a determination by

the agency

that MON 87769 so ybean does not pose a plant pest risk and therefore should no longer be regulated under 7 CFR 340 . Potential environmental impacts from the No Action Alternative and the Preferred Alternative for MON 87769 soy bean are described in detail throughout this section. A cumulative effect s anal ys is is presented for each potentiall y affected environmental concern. Certain aspects of this product and its cultivation would be no different between the alternatives: those instances are described below. **4.1 Scope of the Analysis**  Potential environmental impacts from the No Action Alternative and the Preferred Alternative for MON 87769 so ybean are described in detail throughout this section. An impact would be any change, positive or negative, from the existing (baseline) conditions of the affected e nvironment (described for each resource area in Section 2.0). Impacts may be categorized as direct, indirect, or cumulative. A direct impact is an effect that results solely from a proposed action without intermediate steps or processes. Examples includ e soil disturbance, air emissions, and water use. An indirect impact may be an effect that is related to but removed from a proposed action b y an intermediate step or process. Examples include surface water quality changes resulting from soil erosion due to increased tillage, and worker safety impacts resulting from an increase in herbicide use. A cumulative effects analy sis is also included for each environmental issue. A cumulative impact may

be an effect on the environment which results from the inc remental impact of the proposed action when added to other past, present, and reasonabl y foreseeable future actions. Examples include breeding MON 87769 so yb ean with other GE events that are no longer subject to the regulatory

requirements of 7 CFR part 3 40 or the plant pest provisions of the Plant Protection Act . If there are no direct or indirect impacts identified for a resource area, then there can be no cumulative impacts. Cumulative impacts are discussed in Section 5 . Where it is not possible to quantify impacts, APHIS provides a qualitative assessment of potential impacts. Certain aspects of this product and its cultivation may be no different between the alternatives; those are described below. Although the preferre d alternative would allow for new plantings of MON 87769 soy bean 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 soy bean . According to the developer ( Monsanto, 2010c ) , cultivation of MON 87769 soybean will be limited to the Northern Tier states of North and South Dakota, Mi nnesota, Wisconsin , and Michigan.65

**4.2 Agricultural Production of Soybean**  One of APHIS’s missions is to improve American agricultural productivity. Best management practices are commonly

accepted, practical ways to grow so yb ean, regardless of whether the soy bean farmer is using conventional practices with non - GE or GE varieties, or using organic practice. These management practices consider crop - specific planting dates, seeding rates, and harvest times, among others. Over the years, so yb ean production has resulted in well established, widel y- practiced management practices that are available through local Cooperative Extension Service offices and their respective websites. The National Information System for the Regional Integrated Pest Management Centers (IPM Centers) publishes crop profiles for major crops on a state - by - state basis. These crop profiles provide production guidance for local growers, including recommended practices for specific pest control. Crop profiles for many of the soy bean production states are available at: www.ipmcenters.org/cropprofiles/index.cfm. Monsanto’s field trials have not demonstrated any agronomic or phenotyp ic differences between MON 87769 soy

bean and control varieti es of so ybean ( M onsanto, 2010b ) . Based on the data provided b y Monsanto for MON 87769 so ybean ( Monsanto 20 10) , as well as previous experience with other GE soy bean varieties that have been widel y adopted by growers since their introduction in 1996 (USDA - ERS, 2010b ) , APHIS has concluded that none of the best management practices for agricultural production of soy bean are expected to change MON 87769 soy

bean is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act . Consistent with the lack of changes to agronomic properties, the potential impacts on agricultural production associated with the No Action and Preferred A lternatives are the same. 4.2.1 Acreage and Area of So ybean Production GE and non - GE so yb ean varieties are continuall y under development. In 2009 and 2010, over 75 million acres in the U.S. were planted in so ybean, with over 93% of the soybean expressing herbicide tolerance (USDA - ERS, 2010a , 2010b ) . No Action Alternative: Acreage and Area of So yb ean Production B ased on current acreage trends, commodity soy bean production with GE varieties will likely continue to dominate. Cultivation of GE soy bean increased from 17% of the U.S. soy bean acreage in 1997, to over 93% in 2010. The continued cultivation of soy bean and the penetration of the soy bean market b y GE varieties is not expected to change under the No Action Alternative. Soy

beans are produced commercially in the Northern Tier states (USDA -NASS, 2011a) and under the No Action Alternative, this range of production is not expected to change.66

Preferred Alternative: Acreage and Area of So yb ean Production Monsanto has determined that the SDA content of MON 87769 so ybean seed would be greatest when grown in the most northerl y areas of so yb ean production in the US. Both genotype and environment can simultaneously influence ratios of multiple fatty acids in soy

bean ( Hou et al., 2006 ) . The effects of temperature may be most relevant during the final stages of seed maturation ( Wilcox and Cavins, 1992 ) . By limiting the proposed production area, Monsanto will ke ep the yi eld of SDA at the maximal attainable levels ( Monsanto, 2010c ) . Production in the Northern Tier state s will be encouraged by producing seed only

for the lower maturity groups ( Monsanto, 2010c ) . Monsanto currently produces Vistive ® low linolenic specialty soy bean lines, and has multiple years of experience with IP production of this variety . F rom a survey

of six seed producers selling Vistive ® seed , APHIS observed that Monsanto seed is available mostly

in maturi ty

groups 2 - 3.6, although one was a 1.5. By this means, Monsanto has both focused and restricted the growing area for the Vistive ® low linolenic varieties (offered through various seed companies). Existing Vistive ® varieties are mostly grown in areas where soy bean is already

extensively

produced, while MON 87769 soy bean will be grown in the more northerl y parts of these areas. A second means seed companies employ to direct production of soy bean varieties lines to a specific region is a contractual one. To produce the soy bean crop and receive premium prices, growers must sign a contract with an authorized elevator or processor. For the Vistive ® line, Monsanto lists at least 12 states where commodity seed is purchased or crushed with 127 elevators and 21 processors in major soy bean production areas including Alabama, Iowa, Illinois, Indiana, Maryland, Minnesota, Michigan, Missouri, Nebraska, New York, Ohio, Pennsylvania, and South Dakota ( Monsanto, 2010b ) . This area is partiall y c oextensive with the five - state region proposed by the developer for MON 87769 soy bean. If MON 87769 soy bean seed becomes available, Monsanto would provide growers and the public a list of these elevators and crushers, and they

will likely

be restricted to the five states planned for production of this variety. The area proposed for MON 87769 so ybean production will correlate with soybean oil processors capable of accommodating specialty soybean production. Economic considerations constrain growers from m arketing their so ybeans at too great a distance from the specialty so ybean crusher or elevators. An Indiana survey determined that 80% of growers delivered their soy beans within 25 miles of the growing site. In the northern and central parts of the state, at least 50% of soy beans were delivered within 10 miles (Purdue Extension. 2006). Thus, even if growers purchased the seed for the soy bean variety outside of the expected optimal range, the high cost of transport would likely deter movement beyond that o f authorized regional buyers. If Monsanto authorizes only certain elevators to receive the MON 87769 soy bean, then MON 87769 soy bean seed sales and delivery of harvested beans can be carefully constrained b y the company. Monsanto plans to market MON 877 69 soy bean as a specialty variety for producing the novel constituent SDA by this product ( Monsanto, 2010b ) . Monsanto’s field trials have not demonstrated any agronomic or phenoty pic differences between MON 87769 soy bean and control varieties of so yb ean ( Monsanto, 2010b ) . The changes in fatty acid composition expressed in MON 87769 soy bean do not require changes in cultivation practices when67

compared with other non - GE soy bean varieties ( Monsanto, 2010b ) . MON 87769 soy bean does not confer an increase in cold tolerance, heat resistance, or drou ght tolerance (these issues are discussed again below in the subsection on gene flow) and therefore MON 87769 soy bean is not anticipated to be cultivated in new regions outside of the current so ybean production areas. MON 87769 soy

bean is anticipated to fill a small niche for an omega - 3 fatty acid easil y converted b y human metabolism into desirable longer chain fatty acids. MON 87769 soybean is not expected to significantly replace plantings of conventional or existing GE varieties where those growers se ek to cultivate a commodity soy bean variety ( Monsanto, 2010b ) . Similar to other soy bean traits have recentl y been determined by APHIS to no longer be subject to the plant pest provisions of the Plant Protection Act and 7CFR part 340 that modestly alter fatty acid rati os, MON 87769 has the potential to lead to increases in specialty soy bean acreage . Under the Preferred Alternative, a determination of nonregulated status of MON 87769 soy bean is not expected to increase so ybean production, or result in an increase in overall GE soy bean acreage or cultivation in new regions because this trait is one to be grown for a niche specialty oil market, focused on nutritional augmentation . Impacts would be similar to the No Action Alternative. 4.2.2 Agronomic Practices Crop rotation in s oy

bean is conducted to manage weeds, optimize soil nutrition and fertility , reduce pathogen loads, and control certain soy bean pests (Al - Kaisi et al., 2003 ; University of Illinois, 2006 ) . In crops that have no tolerance to herbicides, such as MON 87769 soy bean, various ty pes of cultivation and herbicide use are ty picall y emplo yed b y soybean growers. Besides tillage practices not alway s used in herbicide tolerant crops, herbicide use would generall y include burndown, preplant and one or more post plant applications of herbicide ( Loux et al., 2008 ) . A more diverse pattern of herbicides would also be used in these situations, rather than principle use of a s ingle herbicide (gly phosate, glufosinate or ALS) applied preplant or over the top, depending on the herbicide tolerant variety planted. No Action Alternative: Agronomic Practices Under the No Action Alternative, soybean crop rotation practices and herbicide pesticide use will likely remain as it is practiced today by the farming community. Growers will continue to have access to existing herbicide - tolerant so ybean products that are no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act , as well as conventional so ybean varieties. A gronomic practices associated with traditional and existing non - regulated GE soybean production would not be expected to change under the N o A ction A lternative . As a result, no changes are anticipated from the current agronomic practices associated with soybean production , including tillage, cultivation, fertilization, pesticide applications, fertilizer applicatio ns, or the use of agricultural equipment. Preferred Alternative: Agronomic Practices Monsanto has determined that the SDA content of MON 87769 so ybean seed would be greatest when grown in the most northerl y areas of so yb ean production in the U.S. ( Monsanto, 2010c ) . Both genotype and environment can simultaneously influence ratios of multiple fatty acids in soy bean ( Hou et al., 2006 ) . The effects of temperature may be most relevant during the final68

stages of seed maturation ( Wilcox and Cavins, 1992 ) . By limiting the proposed production area, Monsanto will attempt to keep the yi eld of SDA at the maximal attainable levels. Monsanto will produce seed onl y for the lower maturity groups ( Monsanto, 2010c ) which will restrict the potential growing area for the MON 87769 soy bean varieties (offered through various seed companies). As with other identity preserved soy

beans, growers must sign a contract with an authorized elevator or processor and which will approve the so yb ean product qual ity before purchase. Elevators and crushers will be restricted to the five states planned for production of this variety . Man y of the growers electing to plant MON 87769 soy bean and also elevators and crushers chosen will likely already have extensive expe rience in strictl y observing standard operating procedures ( SOPs ) to maintain segregation during storage and crush. Otherwise, new growers and producers will be provided with SOPs, and asked to agree to conditions of contracts so as to channel so ybean and oil to purchasers seeking the special fatty acids offered b y MON 87769 soy

bean. Monsanto’s studies demonstrate MON 87769 so yb ean is essentiall y indistinguishable from other soy bean varieties in terms of agronomic characteristics and cultivation practices ( Monsanto, 2010b ; USDA - APHI S, 2010c ) . Monsanto did not identify any differences between MON 87769 soy bean and conventional A352 5 control soy beans in dormancy , germination potential, disease or insect response, seedling vigor, or plant maturity ( Monsanto, 2010b ; USDA - APHIS, 2010c ) . The similarity

in agronomic and phenotypic characteristics suggests that the changes in fatty acid profile do not impact the ability of so ybean to overwinter or become a volunteer. A determination of nonregulated status of MON 87769 soy bean is not expected to alter the use of herbicides currentl y being used for non - GE soy bean production. A preplant burndown herbicide would be used, followed by a pre - emergence residual herbicide, with timely post plant herbicide applications ( Sprague, 2006 ) . The use of gl yphosate as a post - emergent weed herbicide in other soy bean varieties would likely continue to be the pattern for the majority of soy bean production . The tillage procedures if used would be those already employed and include those noted in section 2.2 .2 (Agronomic Practices). Use of pest control strategies, such as those for insects or pathogens would also be unchanged. If MON 87769 so ybean is not stacked with herbicide tolerant traits, control of herbicide tolerant corn or so ybean volunteers from the previous season would not be different from control of such volunteers arising after planting herbicide tolerant crops with ty pical rotational crops. Numerous other registered soy bean herbicides are available to eliminate these volunteers (See Table IX - 4 in Petition ( M onsanto, 2010b ) ). Monsanto’s field trial and laboratory anal ys es demonstrated that the agronomic performance of MON 87769 soy

bean was functionally

identical to its non - transgenic counterpart ( Monsanto, 2010b ) . No increases in fertilizers and pesticides were require d, nor were any changes in cultivation, planting, harvesting, and volunteer control required ( Monsanto, 2010b ) . Itis expected that similar agronomic practices that are currentl y used for other commerciall y available GE so yb ean will also be used by growers of MON 8776 9 soy bean . Overall i mpacts would be similar to the No Action Alternative.69

4.2.3 Soy

bean Seed Production Soy bean seed production is managed by seed producers using AOSCA standard methods to preclude gene flow between varieties ( Bradford, 2006 ; Sundstrom et al., 2002 ) . Soy bean is considered a self

- pollinated species, exhibiting a high - percentage of self - fertilization ( OECD, 2000 ) . Common practices to preserve varietal identity include: 1) maintaining isolati on distances to prevent pollen movement from other soy bean sources; 2) planting border or barrier rows to intercept pollen, employing natural barriers to pollen; and 3) field monitoring for offty pes, other crops, weeds, and disease. No Action Alternative: Soy bean Seed Production Under the No Action Alternative, current soybean seed production practices are not expected to change. Preferred Alternative: Soybean Seed Production Monsanto’s field trials have not demonstrated any agronomic or phenotyp ic differences between MON 87769 soy

bean and control varieties of so ybean ( Monsanto, 2010b ) , other than differences of fatty acid content . Based on the data provided by Monsanto for MON 87769 soy bean ( Monsanto, 2010b ) , as well as previous experience with other GE so ybean varieties that have been widel y adopted b y growers since their introduction in 1996 (USDA - ERS, 2010b ) , APHI S has concluded that the availability of MON 87769 soy

bean would not alter the agronomic practices, locations, and the production and quality characteristics of co nventional and GE seed production (USDA - APHIS, 2010c ) . The overall impact of a determination of nonregulated status of MON 87769 soybean on the availability of conventional and GE seed, and the production practices used to grow so yb ean seeds would be similar to the No Action Alternative. Accordingl y, th ere are no differences between the No Action and Preferred Alternatives with regard to seed production. 4.2.4 Organic So ybean Production Organic production plans prepared pursuant to the National Organic Program (NOP) include practical methods to prevent uninten ded presence of geneticall y engineered materials. Ty picall y, organic growers use more than one method to maintain organic certification and prevent unwanted material from entering their fields including: isolation of the farm, phy sical barriers or buffer zones between organic production and non - organic production, as well as formal communications between neighboring farms ( Baier, 2008 ; Kuepper, 2003 ; NCAT, 2003 ) . These practices follow the same sy stem as that u sed for the cultivation of certified seed under the AOSCA procedures. APHI S recognizes that producers of non - GE so yb ean, particularl y producers who sell their products to markets sensitive to GE traits (e.g., organic or some export markets), can be reasonabl y assumed to be using practices on their farm to protect their crop from unwanted substances and maintain their price premium. APHIS will assume that growers of organic soybean are already using, or have the ability to use, these common practices as a baseline, which APHIS uses for the analyses of the alternatives .70

Historically, organic soybean production represents a small percentage of total U.S. soybe an acreage ( USDA - ERS, 2010f

) . In 2005, 122,217 acres of so yb ean 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 so yb ean production in the U.S. In 2001, 68% of the soy bean crop was herbicide - tol erant, and b y 2010 , 93% of the total acreage was herbicide tolerant (USDA - ERS, 2010a , 2010b , 2010f ) . No Action Alternative: Organic So ybean Production Current availability

of conventional (both GE and non - GE) so ybean varieties, and those so ybean varieties that are developed for organic production, are expected to remain the same under the No Action Alternative. Since 2001, GE varieties of soy bean have dominated the market, representing 68% of the market i n 2001, and 93% of the market in 2010 (USDA - ERS, 2010b ) . Although organic so ybeans 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 soy bean fluctuated between 72 million and 64 million acres, although organic soy beans ranged from 122,000 to 126,000 acres, less than 1% of the total soy bean acreage (USD A - ERS, 2010f ) . The market share for organic soy bean varieties is not expected to change under the No Action Alternative (USDA - ERS, 2010b ; USDA -NASS, 2007a , 2010e ) . Preferred Alternative: Organic Soy bean Production It is not likely

that organic farmers, or other farmers who choose not to plant transgenic varieties or sell transgenic seed, will be substantially impacted by

APHI S’ determination of nonregulated status of MON 87769 soybean . GE soy bean varieties are currentl y cultivated on 93% of the U.S. so ybean acreage (USDA - ERS, 2010b ) , and organic varieties comprise less than 1% of the total soy bean acreage (U SDA - ERS, 2010f ) . In the affected area, onl y 0.3% of so yb ean acreage is organic certified (see Affected Area anal ys is). MON 87769 soy bean should not present any new or different issues and impacts for organic and other specialty soy bean producers and c onsumers. According to the petition, agronomic trials conducted in 200 6 and 2007 at 21 field locations in the U.S. demonstrated that MON 87769 soy bean in combined site anal ys is is not significantly different for plant growth, yield, and reproductive capaci ty from its n ontransgenic counterpart ( Monsanto, 2010b ; USDA - APHIS, 2010c ) . No differences were observed in pollen diameter, and viability ( Monsanto, 2010b ; USDA - APHI S, 2010c ) . Consistent with the lack of differen ce in agronomic properties, MON 87769 soy bean is not expected to have an increased ability to cross pollinate organic soy bean varieties. The practices currentl y employed to preserve and maintain purity of organic production s ys tems would not be required to change to accommodate the production of MON 87769 soy bean . C ommon production practices for soybean and the practical methods typically used by soybean farmers under organic conditions (NCAT, 2003 ) can greatly reduce the likelihood of accidental gene flow between MON 87769 soy bean and non- GE soybean fields. MON 87769 soybean will be marketed by Monsanto as a specialty variety to take advantage of the high content of SDA ( Monsanto, 2010b ) . Consistent with no required differences in71

agronomic practices, and the intention of Monsanto to produce soybean for a specialty market , MON 87769 soybean is not expected to displace current organic soybean production. The acreage devoted to organic soybean is expected to remain sm all regardless of whether new varieties of GE or non - GE soybean varieties, including MON 87769 soy bean , become available for commercial soybean production. As noted above for the time period of 2005 to 2008, when the total U.S. acreage dedicated to soybean fluctuated between 72 million and 64 million acres, the acreage devoted to organic soybeans was relatively stable, reported between 122,000 and 126,000 acres (US DA - ERS, 2010f ) . The percentage of the soybean acreage that was organic in the five state region identified as the affected area is only 0.3% (see affected area). Significant increases in soybean acreage are not expected, so increased GE or conventiona l soybean acreage adjacent to organic plantings is not expected. Consistent with these cultivation trends, a determination of nonregulated status of MON 87769 soy bean is not expected to have a significant impact on organic so ybean growers. 4.2.5 Specialty

Soy be an Production The soy bean industry , supplying both industrial and food products, has numerous products which can meet specialized needs. Established methods of IP have maintained these products, and as more such specialty

products are introduced, will continue to provide them for customers willing to pay premiums beyond those prices given to commodity soy bean producers. No Action Alternative: Specialty Soybean Production Under the No Action Alternative, no changes to soy bean production will occur. These p roducts will continue to be produced for a variety of niche markets beyond that of commodity soy bean. Preferred Alternative: Specialty Soybean Production In the event of a determination of nonregulated status , MON 87769 soy bean would become an additional s pecialty

soy bean variety

that would be produced and marketed as an IP oil. Monsanto plans to exercise product stewardship in a “closed loop” sy stem ( Monsanto, 2010b ) and would supervise the sale and movement of the so ybean from growers to designated buyers, and then af ter extraction, continue to oversee the product through a s ys tem of required SOPs, contracts and agreements to ultimate users. Under a full stewardship plan ( see Appendix C of this EA; Appendix 1 ( Monsanto, 2010b ) ) buyers and users of the oil would be given full information about maintaining product segregation, about necessary procedures and equipment, and Monsanto would make themselves available for consulting with entities in the supply chain. To meet market needs, additional procedures would be assessed, to b e proposed for adoption by the principle users of the product in the marketplace . Using a “closed loop” s ystem, a product of specified quality is produced b y preserving the identity of the product from the seed stock to the processed product until it is p urchased b y the final customer ( Smy th and Phillips, 2002b ) . Because the closed loop sy stem is a robust one, APHI S has concluded that the mechanism Monsanto has proposed would be capabl e of implementing effective isolation from other specialty oils, as well as commodity oils. APHI S concludes that other soy bean specialty

crops would not be affected b y the new SDA producing line MON 87769 soy bean.72

**4.3 Physical Environment**  4.3.1 Water Resources The climate in the Heartland south and east of the Great Lakes, and Eastern portions of the Great Plains of the U.S. provide sufficient water under normal climatic conditions to produce a soy bean crop. The adoption of herbicide - tolerant soy bean varieties has been a factor in the adoption of conservation practices, including conservation tillage. Water quality

is also preserved in modern so yb ean production sy stems. The increase in conservation tillage practices has resulted in a reduction of runoff from agri cultural lands, decreasing non - point source pollution of fertilizer and pesticides. Intensive local monitoring of surface water and sub - soils has demonstrated the benefits of no - till soy bean in protecting both ground and surface water resources (University of Illinois, 2006 ) . No Action Alternative: Water Resources Under the No Action Alternative, l and acreage and agronomic practices, including irrigation, associated with soybean production would not be affected. H erbicide - tolerant soy beans , cultivated on 93% of the soy bean acreage (USDA - ERS, 2010b ) , have resulted in the adoption of increased conservation practices ( Monsanto, 2010b ) . These conservation practices, including reduced tillage and prec ision agriculture , play a significant role in water conservation and maintaining water quality by minimizing soil erosion (USDA -NRCS, 2006c ) . Current application rate s of glyphosate for weed control are not expected to change. Preferred Alternative: Water Resources The acreage on which MON 87769 soy bean is grown might revert to full cultivation tillage if the new variety was not to be stacked with herbicide tolerance, given that such a high percentage of U.S. is currentl y growing herbicide tolerant soy beans. Conservation tillage, facilitated by herbicide tolerant crops (see Section 2.2.2, Weed Control), may decrease the likelihood of run off carrying soil or undesirabl e 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 soy bean to incorporate other expressed traits is considered in Section 5.3 (Cumulative Impacts: Agronomic Practices). MON 87769 soy

bean does not change cultivation practices for soybean production, nor would it increase the total acres and range of U.S. soybean production areas . A determination of nonregulated status of MON 87769 soy bean will not chang e water use in soybean production, as the MON 87769 soy

bean is expected to be used as an alternative crop to GE or non - GE so ybean varieties already in use , offering no additional agronomic benefits to growers . 4.3.2 Soil Quality No Action Alternative: Soil Quali ty A gronomic practices associated with traditional and existing non - regulated GE soybean production would not be expected to change under the N o A ction A lternative . As a result,73

no impacts to the soil environment are anticipated from the current agronomic practices associated with soybean production , including tillage, cultivation, fertilization, pesticide applications, fertilizer applications, and the use of agricultural equipment. Preferred Alternative: Soil Quality Monsanto’s field trial and laboratory anal ys es demonstrated that the agronomic performance of MON 87769 soy

bean was functionally

identical to its non - transgenic counterpart ( Monsanto, 2010b ) . No increases in fertilizers and pesticides were required, nor were any changes in cultivatio n, planting, harvesting, and volunteer control required ( Monsanto, 2010b ) . Itis expected that similar agronomic practices that are currentl y used for other commerciall y available GE so yb ean will also be used by growers of MON 87769 so ybean . Therefore, under the Pref erred Alternative there are no expected impacts to soil quality . 4.3.3 Air Quality Traditional agricultural practices have the potential to cause negative impacts to air quality . Agricultural emission sources include smoke from agricultural burning, tillage, traffic and harvest emissions, pesticide drift from spraying, and nitrous oxide emissions from the use of nitrogen fertilizer (USDA -NRCS, 2006a) . Other GHG emission sourc es associated with agricultural production include equipment emissions (contributing carbon monoxide, nitrogen oxides, and reactive organic gases), particulate matter, sulfur oxides, and direct emissions of N2 O from fertilizer application (US - EPA, 2010a) . Conservation practices, including conservation tillage associated with GE soy bean production, requires fewer tractor passes across a field ( Baker et al., 2005 ; USDA -NRCS, 2006a) . This results in a decrease in dust generation and tractor emissions ( Baker et al., 2005 ; USDA -NRCS, 2006a) . Surface residues and untilled organic matter phy sicall y hold the soil in place thus decreasing wind erosion of soils and pesticide drift in wind - eroded soils ( Baker et al., 2005 ; USDA -NRCS, 2006a) . Reduced tillage also increases sequestration rates of potential carbon emissions from soils ( Causarano et al., 2006 ) . No Action Alternative: Ai r Quality Under the No Action Alternative, c urrent impacts to air quality associated with land acreage and cultivation practices associated with soybean production would not be affected. Agronomic practices associated with conventional soybean production and current GE soybean varieties and which contribute to air quality and GHG emissions, including tillage, cultivation, irrigation, pesticide application, fertilizer applications and use of agriculture equipment, would not be expected to change. Preferred Alternative: Air Quality A determination of non - regulated status of MON 87769 soy bean will not change the cultivation or agronomic practices, or agricultural land acreage associated with growing so ybean, and is expected to have the same effect on air quali ty as the No Action Alternative.74

4.3.4 Climate Change No Action Alternative: Climate Change Under the No Action Alternative, c urrent impacts on climate change associated with soybean production would not be affected. Agronomic practices associated with soy bean production such as tillage, cultivation, irrigation, pesticide application, fertilizer applications and use of agriculture equipment would continue on soy beans grown throughout the region. Preferred Alternative: Climate Change T here is unlikel y to be a me asurable change in an agricultural practice that might affect climate change in soy

bean fields where MON 87769 so yb ean would be grown . Agronomic practices associated with so ybean production such as tillage, cultivation, irrigation, pesticide application, fertilizer applications and use of agriculture equipment would continue on soy beans grown throughout the region. Therefore, there would be no change in agricultural activities that might contribute to climate change. A determination of non - regulated statu s of MON 87769 soy bean is expected to have the same effect on climate change as the No Action Alternative. **4.4 Biological Resources**  4.4.1 Animal Communities Soy bean production s ys tems in agriculture are host to many animal species. Mammals and birds may use so yb ean fields and the surrounding vegetation for food and habitat throughout the ye ar. Invertebrates can feed on soy bean plants or prey

upon other insects living on soy bean plants as well as in the vegetation surrounding so yb ean fields. The cumulative effects analy sis for the potential effects of the production of MON 87769 soy bean 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, conventi onal and GE soy bean production would continue while MON 87769 so ybean remains a regulated article. Potential impacts of GE and non - GE soy bean production practices on non - target animals would be unchanged. Preferred Alternative: Animal Communities Monsanto data indicate that the agronomic practices used to produce MON 87769 soy bean will be the same as those used to produce other conventionally grown GE and non- GE soybean. MON 87769 soy

bean production is not expected to change land acreage or any cultivatio n practices for soy bean production. MON 87769 soy

bean provides a modified fatty acid profile based on the introduction of Primula juliae Δ6 desaturase (Pj.D6D) and Neurospora crassa Δ15 desaturase (Nc.Fad3) . Change s in fatty acid composition resulting from the expression of these genes are not expected to cause75

impacts to animals consuming the so ybean. MON 87769 soy bean contains two principle new fatty acids, stearidonic (26% of total fatty acids) and gamma - linolenic (7%). MON 87769 soy bean contains mod estly

reduced oleic acid and substantially reduced linoleic fatty acids compared to the typical range of fatty acids found in commodity soy bean oil (Table E - 16 ( Monsanto, 2010b ) ) . MON 87769 soy bean has a fatty

acid profile that is comparable to commercial high oleic v egetable oils (e.g., high oleic canola, high oleic safflower, high oleic sunflower), traditional oils such as olive oil that has a long - history of consumption in the diet, and canola oil that obtained FDA GRAS (Generally Recognized as Safe) status. Table 14 presents a comparison of fatty acid profiles of several plant sources of vegetable oil, including conventional soy

bean and MON 87769 soy bean . **Table 14.**  **Comparison of**  **f atty**  **a cid**  **p rofiles**  **for oil**  **derived from**  **MON 87769**  **soybean with**  **s everal**  **o ther**  **p lant**  **s ources**  **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 3 6 MON 87769 Soy bean 13 16 26 11 26 67 MON 87705 Soy bean 6 76 10 7 0 17 Conventional Soy bean 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, 2010b ) . Notes: 1. Percent fatty acid presented as a percent (%) of total fatty acids. 2. Ratios presented within parenthesis represent the lipid numbers for the subject fatty acid, one of the more common nomenclature sy stems. The first number, e.g., 18, indicates the number of carbon atoms in the fatty acid, and the second number, e.g., 1, indicates the number of double bonds in the fatty acid. A f atty acid is considered saturated when there are no double bonds in the carbon chain, hence the 18:3 linoleic acid would b e considered a polyunsaturated fatty acid, presenting three double bonds across the 18 carbons. 3. From Table VII - 1 ( Monsanto, 2010b ) ; ( Monsanto, 2010c ) . 4. Alpha linolenic totals; add 7% additional for gamma linolenic in MON 87769 soybean 5. A3525, the variety originally transformed, a conventional variety. Monsanto statistically

analyzed 42 seed components and seven in forage. The samples were collected at five sites and included a combined site anal ys is. Some 28 differences between the MON 87795 and control observations for constituents were significantly different, but except for linoleic acid, were either within the published v ariability of existing commercial cultivars, or were actuall y within a 99% tolerance limit based on existing commercial cultivar values. Linoleic acid was expected to be different, because it is a substrate for the desaturases introduced into the soy

bean to make SDA. In seed, statistically significant differences were found in 19 nutrients other than fatty acids including amino acids in combined site analyses, and these were all of less than 10%, but were not outside the 99% tolerance level for commercial soy bean properties. Differences in fatty acids (including linoleic acid) in combined - site anal ys es between MON 87769 soy

bean and a conventional control included six fatty acids of the eight anal yz ed.76

Except for linoleic acid, a substrate for the introdu ced desaturases, all of these differences were within the 99% tolerance level for commercial content of these fatty acids (Monsanto, 2010). Animals are known to forage on so ybean foliage and seed. With the exception of the introduction of the desaturase genes, genes to change fatty acid composition, no phenotypic or morphological differences have been identified between MON 87769 so yb ean and conventional soy beans. Composition of MON 87769 so ybean forage was compared to a conventional control (the host variety used in the transformed variety) and anal yz ed for fiber and no combined site differences were found, although one site of the five showed an increase. For proximates, fat was slightl y decreased at one site of five; neither difference was outside the commercial tolerance range. No observable adverse effect of feeding up to 4 g of SDA oil/kg body weight per day was determined in a 90 day , one - generation reproductive rat toxicity study ( Hammond et al., 2008 ) . T he two new proteins in MON 87769 are homologous to many other desaturases found in food or feed, have no similarity to known toxins, are present at very low quantities in foods, and are readily

digestible in simulated gastric and digestive fluids ( Monsanto, 2010b ) . T he potential risks to animals from the consumption of MON 87769 so ybean with modified fatty acid composition will be evaluated b y the FDA ( Monsanto, 2010b ) . Soy bean meal is the most common supplemental protein source in U.S. livestock and poultry rations due to its nutrient composition, availability, and price. Although MON 87769 soy bean is intended to be cultivated as a specialty

soy bean to take advantage of the SDA production , the so ybean meal remaining after the extraction of the soy bean oil may

become a constituent of livestock or poultry food supplements . Monsanto completed a feeding study and a one generation reproduction study on rats using oil derived from the MON 87769 soy beans and fed in substantial quantity . No adverse treatment related effects were determ ined from either study (Hammond et al., 2008). Mo nsanto is completing a consultation with FDA on the possible impacts on animals using feed containing MON 87769. The analy sis will compare the composition of MON 87769 soy bean with the conventional non - tran sgenic soy bean variety A3525 (also the original line used for the transformation) , and evaluate the potential impacts to animal diets from the reduced intake of linoleic acid . Al though the soy bean meal derived from MON 87769 so ybean would have reduced lev els of linoleic acid, the animal’s requirements for linoleic acid could be met by other ingredients in animal feed. One important use of MON 87769 will be to enhance the omega - 3 fatty acids in animal tissues, either with stearidonic acid itself, or with the elaborated fatty acids, DHA and EPA. Broiler chickens were fed with soy oil from the MON 87769 SDA line, from isogenic lines and with fish oil. Feeding MON 87769 oil increased the incorporation of three desirable fatty acids over the isoline fed anim als, and the treatments did not change the intake, weight gain or feed conversion efficiency ( Ry

mer et al., 2011 ) . Similarly , MON 87769 SDA - containing oil when fed to sea bass can increase the DHA concentrations in fish muscle (Bharadwaj ( Bharadwaj et al., 2010 ) et al., 2010). When introduced into the abomasum of dairy cows, MON 87769 oil can increase omega 3 fatty acids five fold over control with no impact on milk pro duction or on milk fat yield (Bernal - Santos ( Bernal - Santos et al., 2010 ) . Based on the above information, APHI S concludes that a determination of nonregulated status of MON 87769 soy

bean is not expected to have adverse effects on non - target animals.77

4.4.2 Plant Communities The landscape surrounding a soybean field may be bordered by o ther soybean (or any other crop) fields or may also be surrounded by woodland, rangelands, and/or pasture/grassland areas. These plant communities may be natural or managed plant habitats for the control of soil and wind erosion and/or serve as wildlife h abitats. In this context, weeds are those plants which, when growing in the so yb ean field, compete with the soy bean for space, water, nutrients and sunlight, and may thus include native species. The types of weeds in and around a soybean field will vary d epending on the geographic region where the soybean is grown , as is apparent from control recommendations in various states ( Aref and Pike, 1998 ; Byrd et al., 2003 ; Duke and Powles, 2009 ; Loux et al., 2009 ) . No Action Alternative: Plant Communities Plant species that typically inhabit soybean production systems will continue to be managed through the use of mechanica l, cultural, and chemical control methods, including the use of glyphosate in those varieties already marketed as glyphosate - tolerant. No changes to cultivation practices are expected in the No Action Alternative. Preferred Alternative: Plant Communities In the event of a determination of nonregulated status of MON 87769 so yb ean , the risks to wild plants and agricultural productivity from weedy s oy

bean populations are low; volunteer soy bean populations are easily

managed and there are no feral or weedy rel atives. Agronomic studies conducted b y Monsanto tested the hypothesis that the weediness potential of MON 87769 soy bean is unchanged with respect to conventional soy bean ( Monsanto, 2010b ) . No differences were detected between MON 87769 soy bean and nontransgenic so y bean in growth, reproduction, or interactions with pests and diseases, other than the intended effect , which is production of SDA . Volunteer soy bean is normally

not a concern. So ybean is not winter hardy, and existing mechanical and chemical methods are available to manage the occasional volunteer soy bean in cultivation areas ( Carpenter et al., 2002 ; OECD, 2000 ) . Several post - emergent herbicides are also widely used to control the presence of volunteer soy beans in subsequent rotational crops ( See Table IX - 4 ( Monsanto, 2010b ; Zollinger, 2010 ) ). Based on these biological limitations, as well as readil y available control practices, a determination of nonregulated status of MON 87769 so ybean is not likely to result in increased weediness. Overall impacts would be similar to the No Action Alternative. 4.4.3 Gene Flow and Weediness Two forms of gene flow are evaluated: Vertical gene flow and horizontal gene flow. Vertical gene flow, or h yb ridization and associated introgression, is the movement of genes to sexually compatible relatives ( Ellstrand, 2003 ; Quist, 2010 ) . The soy bean is considered self

- pollinating, and has no wild relatives in the U.S. ( Monsanto, 2010b ; OECD, 2000 ) . Although some cross pollination can occur, AOSCA identity protection practices have been found adequate to prote ct against such gene flow ( Monsanto, 2010b ; OECD, 2000 ; USDA - APHIS, 2010c ) . The onl y rel atives of so ybean are other varieties currently cultivated. In assessing the risk of gene introgression from MON 87769 soy bean to its sexually

compatible relatives, APHI S considered78

two primary

issues: 1) the potential for gene flow and introgression to soy bean relatives; and 2) the potential impact of introgression. Vertical gene flow is discussed below in the anal ys is of the Preferred Alternative. Horizontal gene flow represents the stable movement of genes from one organism to another without reproduc tion or human intervention ( Keese, 2008 ; Quist, 2010 ) . There is no evidence of naturally occurring transgene movement from transgenic crops to sexually incompatible species ( Stewart, 2008 ) . Horizontal gene transfer and consequent expression of DNA from one plant to another sexually

incompatible plant or other phyla (e.g., species of bacteria) is unlikely to occur ( Keese, 2008 ) . This event would require phy sical relocation of the functional genetic sequences from the transgenic plant to the new location, including not only the genes which code for the production of specific proteins, but also those portions of the genome which regulate the activity of those genes ( Keese, 2008 ; Stewart, 2008 ) . There are no known naturally occurring vectors (such as plasmids, phages, or transposable elements) that could be responsible for inter- domain gene transfer, and there is little evidence that eukaryotic cells are naturall y capable of stabl y incorporating genes from the environment into their genome ( Brown, 2003 ) . Although viruses do move genetic material, all viruses that infect higher plants have small RNA or DNA genomes, usually with fewer than 20 encoded proteins ( Keese, 2008 ) . These viruses are, therefore, constrained as to the type and size of novel genetic material which can be acquired by horizontal gene transfer ( Stewart, 2008 ) . The development of herbicide resistance , particularl y that found in crop field s treated with gl yphosate, is thus not a result of gene transfer but is the result of selective pressures associated with herbicide use. This issue is discussed in the subsection on impacts to plant communities. Two bacteria species commonly associated with plants, Agrobacterium and Rhizobium, have been evaluated to determine the probability of horizontal gene transfer between the bacterium and their host plants. Agrobacterium moves its genes from its bacterial plasmid to the plant causing the plant to produce the gall; Rhizobium aids in nitrogen fixation in legume nodules ( Stewart, 2008 ) . The genomes of both bacteria have been sequenced, and the sequenced genes evaluated in search of exogenous genes ( Kaneko et al., 2000 ; Kaneko et al., 2002 ; Wood et al., 2001 ) . Despite what would appear to be millennia of s ymbiotic relationships between these bacteria and their host plants, there is no evidence that these organisms contain genes derived from plants (USDA - APHIS, 2010c ) . In cases where review of sequence data implied that horizontal gene transfer occurred, these events are inferred to occur on an evolutionary time scale of millions of years ( Brown, 2003 ; Koonin et al ., 2001 ) . Transgene DNA promoters and coding sequences are optimized for plant expression, not bacterial expression (USDA - APHIS, 2010d) . Horizontal gene flow, resulting in the relocation of entire transgenes including the regulatory

portions of the DNA (those parts of the DNA which code for the production of the specific proteins in that relocated transgene) has never been shown to occur in nature ( Clarke, 2007 ; Stewart, 2008 ) . Thus, even if horizontal gene transfer occurred, proteins associated with these transgenes are not likely to be produced in the new host organism ( Stewart, 2008 ; USDA APHI S, 2010c ) . Based on this information, APHIS considers the horizontal gene flow from MON 87769 soy

bean or other cultivated GE so yb ean varieties to unrelated species to be unlikely .79

No Action Alternative: Gene Flow and Weediness Under the No Action Alternative, conventional and GE transgenic so yb ean production will continue to be grown commercially , while MON 87769 soy bean will remain a regulated article. So ybean cultivation practices are expected to remain the same. Gene flow from current commerciall y available GE cultivars to non - GE soy bean cultivars is expected to remain unchanged from the current conditions. Preferred Alternative: Gene Flow and Weediness APHI S evaluated the potential for gene introgression to occur from MON 87769 soy bean to sexually compatible varieties and considered the possibility that such introgression would result in increased weediness. Monsanto’s data found no significant difference in pollen morphology and viability

from field grown MON 87769 so ybean plants and other so ybean varieties. The soy bean is not identified as a weed in the U.S. (USDA - APHI S, 2010c ) . Soy beans are not frost tolerant, do not survive freezing temperatures, and do not reproduce vegetatively ( OECD, 2000 ; USDA - APHIS, 2010c ) . Some research suggests that fatty acid composition may

influence cold tolerance and surv ivability . Kodama ( Kodama, 1994 ) and Kodama et al . ( Kodama et al., 1995 ) found that increases in levels of certain fatty acids, particularly

hexadecatrienoic and linolenic acids, results in an increase in cold tolerance. In MON 87769 soy bean , the levels of linolenic acid are within the lower end of the commercial range of fatty acid composition when compared with other varieties ( Monsanto, 2010b ) . Changes in oleic acid or linoleic acid composition and reductions in saturated fatty acids have not been li nked to increased cold tolerance. The changes in fatty acid composition MON 87769 soy bean are not expected to enhance cold tolerance (USDA APHI S, 2010c ) . In its PPRA , APHI S assessed the weediness potential of MON 87769 soy bean based on the introduced Primula juliae delta - 6 desaturase ( Pj.D6D ) and the Ne urospora crassa delta - 15 desaturase (Nc.Fad3) genes controlling fatty acid composition (USDA - APHIS, 2010c ) . The changes introduced in the MON 87769 so ybean were deemed to not present a weediness risk (USDA - APHIS, 2010c ) . The change in composition of fatty acid in MON 9 877 69 Soy bean is due to the activity of the endogenous Pj.D6D and the Nc.Fad3 genes in the soy bean. The se two genes pose no novel risks from a plant pest perspective (USDA - APHIS, 2010c ) . The action of these two genes in MON 87769 soy

bean is not anticipated to give rise to an enhanced weediness or gene flow. In its petition, Monsanto presented information on phenotypic and agrono mic characteristics collected from field studies ( Monsanto, 2010b ) . These data included information on seed dormancy , germination, emergence, seedling vigor, plant height, lodging, day s to maturity, shattering, seed weight, yields, disease incidence, and insect damage , among others ( Monsanto, 2010b ) .80

APHI S has assessed those parameters including some of those noted above to evaluate the weediness potential of MON 87769 soy bean. Monsanto found no biologically significant differences between MON 87769 soy bean and the original comm ercial variety that was transformed for seed dormancy , germination, early stand count, seedling vigor, day s to 50% flowering, lodging, pod shattering, and final stand count . All values were within the recommended standards for certified so ybean seed (AOSCA, 2009 ) . To determine whether the variety could be more likely to increase gene flow, Monsanto studied pollen viability

and morphology . No statisticall y significant differences were detected between MON 87769 soy

bean, the original m odified line, and other controls for percent viable pollen or pollen grain diameter ( Monsanto, 2010b ) . No differences in pollen morphology were observed. Thus, differences in gene flow to other so ybean are unlikely. Results from the phenotypic and agronomic assessments indicate that MON 87769 soy bean does not possess characteristics that would confer a plant pest risk compared with conventional soy bean (USDA - APHIS, 2010c ) . These data indicate that the engineered plant is not different in any fitness characteristics from its parent that are likely to cause the MON 87769 soy bean to become weedy or invasive (USDA - APHI S, 2010c ) . Based on the above information, APHIS has concluded that a determination of nonregulated status of MON 87769 soy bean will not impact other soybean varieties through gene flow or introgression, nor would it present a greater risk of weediness or invasive characteristics (USDA - APHIS, 2010c ) . MON 87769 soybean is expected to have the same effect on gene movement as the No Action Alternative. 4.4.4 Microorganisms Microorganisms in soil are important components that sustain and provide the dy namic aspe cts of soil associated with critical ecological processes. Nutrient cycling, establishing soil structure contributing to plant growth, metabolism of deleterious components are all dependent on the microbial constituents. The health and growth of these m icrobes may be influenced b y many processes and conditions. No Action Alternative: Microorganisms There would be no changes to current cultivation practices under the No Action Alternative. Microbes in the field would continue to be exposed to gl yphosate and other herbicides. Preferred Alternative: Microorganisms Monsanto conducted field observations to assess potential agronomic differences between MON 87769 soy

bean and conventional soy bean (variety A3525 , used for the transformation) over two ye ars and at a total of 21 locations ( Monsanto, 2010b ) . The disease anal ys is included observations of a wide range of bacterial and fungal pathogens, nematodes, and plant viruses (Table I - 4, I - 5 ( Monsanto, 2010b ) ). No significant incidence of disease damage w as noted between MON 87769 soy bean and the comparison variety ( Monsanto, 2010b ) . The lack of difference indicates that the expression of stearidonic and gamma linolenic acid and modified81

fatty acid content by MON 87769 soy bean does not change so ybean interactions with microorgan isms in the field. Monsanto also evaluated the potenti al impacts of these changes on the s ymbiotic relationship of soy bean with the nitrogen - fixing root nodule bacteria Bradyrhizobium japonicum ( Monsanto, 2010b ) . In these studies, MON 87769 soy bean was compared with the original transformed conventional line, and six conventional soy bean varieties as well as the negative isoline for MON 87769 soy

bean ( Monsanto, 2010b ) . No significant differences were detected between MON 87769 soy

bean and any

of the comparison varieties for nodule number, biomass of nodules, shoot total nitrogen (percent and mass), or shoot and root material ( Monsanto, 2010b ) . These results indicate that the expression of the modified fatty acid composition does not impact the biology of root nodules formation by the s ymbiotic bacteria. Consistent with these test results, the impacts of a determination of nonregulated status of MON 87769 soy

bean on microorganisms is the same as the No Action Alternative. 4.4.5 Biodiversity Biodiversity

in an agroecosy stem depends on four primary characteristics: 1) diversity of vegetation within and around the agroecos ys tem; 2) permanence of various crops within the sy stem; 3) intensity

of management, including selection and use of insectic ides and herbicides; and 4) extent of isolation of the agroecos ys tem 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 agroecos ys tem landscape. Some enhancement strategies include intercropping (the planting of two or more crops simultaneously to occup y the same field), agroforestry , crop rotations, cover crops, no - tillage, composting, green manuring (growing a crop specificall y for the purpose of incorporating it into the soil in order to provide nutrients and organic matter), addition of organic matter (compost, green manure, animal manure, etc.), adoption of integrated pest management technique s, and the use of hedgerows and windbreaks (Altieri, 1999 ; Palmer et al., 2010 ) . The adoption of GE crops, with the concomitant reduction in insecticide use and enhanced soil conservation practices, has also contributed to the increase in biodiversity

of soil microorganisms, beneficial organisms, and plants ( Dively and Rose, 2003 ; Naranjo, 2009 ; Palmer et al., 2010 ; Sanvido et al., 2006 ) . No Action Alternative: Biodiversity Under the No Action Alternative, MON 87769 soy bean would continue to be a regulated articl e . Growers and other parties who are involved in production, handling, processing, or consumption of soy bean would continue to have access to GE soy bean varieties that are no longer subject to the regulatory

requirements of 7 CFR part 340 or the plant pes t provisions of the Plant Protection Act , herbicide - tolerant soy bean varieties, and conventional soy bean varieties. The implications of agronomic practices associated with soybean production whether traditional or GE varieties with the attendant effects o n biodiversity would not change. Preferred Alternative: Biodiversity Although so ybean fields are cultivated as monocultures to optimize soy bean yield, the landscape adjacent a soy

bean field may

harbor a wide variety

of plants. Broad spectrum herbicide82

app lication has the potential to impa ct off - site plant communities. The herbicide choices used for cultivation of MON 87769 soy bean w ill not be different from those used by growers for weed control on other non - herbicide tolerant varietie s , and acreage is no t expected to exceed 100,000 acres in five years ( Monsanto, 2010b ) . Consequently , production MON 87769 soy bean is not expected to result in an increase in the application of herbicides or frequency of application over other existing non GE soybean varieties. A determination of nonregulated status of MON 87769 soy

bean is not expected to change the cultivation or agronomic practices, or agricultural land acreage as sociated with growing so ybean. The stearidonic and gamma linolenic acid expressed in MON 87769 so ybean, which are also expressed in some other plants, fish, and algae, would have no effect on animals that might feed on soy bean, because the novel oils have been shown to have no harmful consequences b y feeding (see FDA acceptance of GRAS status of oils from this variety). Monsanto has shown that expression of the two new proteins in MON 87769 soy bean are homologous to many other desaturases found in food or feed, have no similarity to known toxins, are present at very low quantities in foods, and are readily digestible in simulated gastric and digestive fluids ( Monsanto, 2010b ) . Thus, no potential for allergic response has been demonstrated by consuming the meal deriving from the so ybean. Therefore, a determination of nonregulated status of MON 87769 soy bean is hi ghl y unlikely to have any direct toxic effects on non - target organisms and is likely to be neutral or beneficial to animal and plant biodiversity . The abundance of diverse beneficial insects was assessed over two ye ars in four states (Tables I 8 and I - 10 ( Monsanto, 2010b ) ). No consistent differences were noted in the populations of these insects over three collections spanning reproductive development of the so ybean. The insects surveyed included Carabid and lady bird 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 soy bean would not change the use of insecticides to manage the invertebrate pests of so ybean since there is no difference in insect damage or populations of pest insects in MON 87769 soybean and conventional control soy bean ( Monsanto, 2010b ) . Populations of pest insects were assessed in four states comparing MON 87769 soy bean and conventional line A3235, th e parental line during two growing seasons (Monsanto, 2010). Aphids, beanleaf beetles, leaf hoppers and three moth pests among others were assessed over three collection periods during the reproductive phase of plant growth. No consistent differences were found in populations of insects in these locations and years. Practices currentl y emplo yed for the management of conventional and other GE soy bean would likel y continue for this crop. In this regard, a determination of nonregulated status of MON 87769 soy bean would have the same impacts on biodiversity as the No Action Alternative. **4.5 Human Health**  4.5.1 No Action Alternative83

Public Health Under the No Action Alternative, MON 87769 soybean would continue as a regulated article. Human exposure to existing tradi tional and GE soy bean would not change under this alternative. Growers and consumers exposure to this product would be limited to those individuals involved in the cultivation of MON 87769 soy bean under regulated conditions. Worker Safety During agricultu

ral production of soybean, agricultural workers and pesticide applicators may be exposed to a variety of EPA registered pesticides (see, e.g., http://www.cdc.gov/niosh/topics/pesticides/). Such chemicals would be expected to include those products currently used for insect pest and plant pest management in both GE and non - GE soybean cultivation. Worker safety is taken into consideration when a U.S. EPA pesticide label is developed during the reg istration process. When use is consistent with the label, pesticides present minimal risk to the worker. Industrial production of soybean oil has standard hazards common to many manufacturing processes. No changes to current worker safety are anticipate d under the No Action Alternative. 4.5.2 Preferred Alternative: Human Health Public Health APHIS considers the FDA regulatory assessment in making its determination of the potential impacts of a determination of nonregulated status of the new agricultural produc t. 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 soy bean 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 chara cteristics of the oil, and safety of its use in foods (US - FDA, 2009a) . Monsanto’s intention i n developing MON 87769 soy bean is to provide a plant source of omega - 3 fatty acid that can efficiently

be converted to the long chain poly unsaturated fatty

acids, DHA and EPA, which are important in prevention or improvement of human health conditions. Oil derived from MON 87769 soy bean would be used to enrich a wide variety of foods, including processed foods, margarine, salad dressings, and other selected food categories. APHI S has considered the human health impacts associated with the new fatty acid s expressed in MON 87769 soy

bean deriving from activity of the two desaturases, PjD6D and Nc.Fad3. The possible impacts of ingestion of the proteins were considered , as were the new fatty acids. Neither desaturase protein formed b y the introduced sequence s have amino acid segments that are structural or immunologically relevant to human allergens, and both are easily degraded by simulated gastric and intestinal fluids ( Monsanto, 2010b ) . The two proteins were purified from immature soy

bean seed, and tested for adverse effects on mice ( Monsanto, 2010b ) . A ‘No Observed Effect Level’ (NOEL) was found for mouse ingestion up to 37.3 mg/kg body weight, which is 29,000 and 47,000 times the concentration expected in human diet when containing oils from MON 87769 so ybean.84

Monsanto presents d ata comparing the fatty acid and other nutritional element concentrations with the reported ranges for conventional so ybean against commercial tolerance ranges (see summary Table 15, below). MON 87769 so ybean fatty acids are compared with conventional soy bean and commercial ranges of these fatty acids. Inaddition to evaluating the targeted fatty acid composition, Monsanto evaluated non - fatty acid nutrients, anti - nutrients, proximate and fiber levels, consistent with the compositional guidance provided b y the OECD ( OECD, 2001 ) . **Table 15:**  **C omparison**  **of percentage**  **fatty acid**  **in MON**  **87769 soybean**  **with c**  **onventional s**  **oybean c**  **ontrol (A3525) and c**  **omme rcial**  **range. Fatty Acid**  **Total Percent (%)**

**MON 87769 Soybean**  **Mean Conventional** 

**Soybean (A3525) Mean**  **Commercial**

**Soybean Range**  16:0 p almitic 12.1 11.8 9.9 - 12.3 18:0 s tearic 4.2 4.2 3.7 - 4.9 18:1 o leic 15.2 19.2 16.7 - 23.2 18:2 l inoleic 22.8 54.9 53.4 - 57.4 18:3 alpha - linolenic 11.2 9.2 7.0

– 10.6 18:3 gamma - linolenic 7.1 N/A N/A 18:4 stearidonic 26.1 N/A N/A Source : Table E - 12 and Table VII - 1 (for percentage of new fatty acids) ( Monsanto, 2010b ) . From the summary

Table 14 , total saturated fat (as measured by palmitic and stearic acid percentages) in MON 87769 soy bean was similar to that of conventional soy bean and olive oil. The mean level of oleic acid decreased 4% in MON 87769 soy bean compared to the conventional soy

bean variety

(Table 15). Linoleic acid decreased from 54.9% in conventional soy bean to 22.8% in MON 87769 soy bean , and this is reflected in the appearance of stearidonic in MON 87769 soy

bean at 26.1%. There was a 2% in crease in alpha - linolenic acid in MON 87769 soy

bean when compared to the conventional variety and the appearance of gamma linolenic acid of 7 %. Overall, the total poly unsaturated fatty

acids of MON 87769 soy bean and conventional soy

bean are similar. SDA commonly

occurs within the environment, and is found in 17 plant families and over 200 species at more than 1% of fatty acid content (p. 8 ( Monsanto, 2010b ) ) and gamma - linolenic acid is found in at least 13 species (Table X - 1 ( Monsanto, 2010b ) ). Many plant species are cultivated as a source of these omega - 3 fatty acids, such as Echium spp., black currant, and Borago officinalis . No adverse effects on human subjects were reported in a study of healthful effects85

associated with consuming so ybean oil from MON 87769 (containing SDA) ( ( Lemke et al., 2010 ) ) . Man y fish species have measureable content of SDA (Table X - 2 ( Monsanto, 2010b ) ) and fish oil is extensively

consumed for the benefit of providing the long chain poly unsaturated fatty acids (Addendum to petition ( Monsanto, 2010b ) ). Monsanto measured compositional aspects of MON 87769 soy bean and compared these data with conventional soy

bean. As earlier noted, SDA and also gamma linolenic acid are not found in commodity

soy bean. Although the animal feed consultation with FDA is pending, submitted data showed that these new components are both intermediates in mammalian systems during production of DHA and EPA, and also are found in the environment in numerous other plant and animal sources. Linoleic acid (18:2) is decreased to about 41% of control percentage, and this altered MON 87769 so yb ean constituent is similar to that found in canola oil. Statistically significant but small differences were observed in the comparisons of the A3525 conventional variety to MON 87769 soybean in the concentrations of several fatty acids (16:0 palmitic, 18:0 stearic, 18:1 oleic, 18:3 alpha linolenic acid, 20:0 arachidic, 22:0 behenic). APHI S evaluated these differences in composition and has determined that those reported for MON 87769 so ybean eith er fall within the ty

pical commercial range for percentage composition or the 99% tolerance interval for commercial soy bean composition ( Monsanto, 2010b ) . Several amino acid percentages, % dry

weight of proximates (protein and carbohydrate), and two isoflavones were also different from controls, but these also were within either the range of commercial values or the 99% tolerance level for commercial soy bean ( Monsanto, 2010b ) . MON 87769 soy

bean was produced to make available an additional source of SDA, which is a healthful omega - 3 fatty acid that can be obtained from other plant sources, fish and algae on commercial scales ( Monsanto, 2010b ) . Monsanto 87769 stearidonic acid soy bean would likel y be a lower cost alternative to marine - derived omega - 3 oils ( Kennedy et al., 2012 ) . The key contribution of SDA is that it is a precursor for the fatty acids DHA and EPA, which have been shown by a variety of clinical and research reports to reduce adverse cardiovascular incidents, reduce inflammatory

mediators, reduce cancer risk and inhibit tumor growth (see review in Whelan, 2006). EPA alone may influence these outcomes, but administration of SDA can equal the impacts on these con ditions (see review in Whelan, 2006). The Preferred Alternative impacts to human health differ from the No Action Alternative with regard to potential human health benefits associated with consumption of the oil from this crop. Monsanto’s anal ys is ( Monsanto, 2010b ) su ggest s that enhancing food oils with the soy bean oil extracted from the MON 87769 soy bean may have a positive impact on human health when used in many foods for which it is suitable . The addition of SDA using oil derived from MON 87769 soy bean oil may

ben efit many

health conditions, both as preventative and as remedial. The extent to which positive benefit s may be observed is contingent upon the market share of the MON 87769 soy

bean and the ty

pes of food products to which manufacturers add the modified oil, but it is likely

to begin to be incorporated into processed foods only after a lengthy

period of food ingredient adaptation and then marketing to the public to attain acceptance . Based on APHI S’ review of field and laboratory data and scientific lit erature provided by Monsanto ( Monsanto, 2010b ) , and safety data available on other GE so ybean, APHI S has concluded that under this alternative, a determination of nonregulated status of MON 87769 soy bean would have no significant impacts on human health.86

Worker Safety If MON 87769 so ybean is adopted, growers during the course of production will be exposed to the same pesticides as those ty pical of other non - herbicide tolerant soy bean varieties. As MON 87769 soy

bean does not require different cultivation practices than currentl y available gl yphosate - tolerant so yb ean, this level of herbicide exposure is expected to be the same as the No Action Alternative. Soy bean processing and manufacturing will not be altered by use of MON 87769 soy

bean, and workers will not be exposed to any new equipment or chemicals to which they had not already been exposed. The novel fatty acid s stearidonic and gamma linolenic acid derive from two enzy mes (desaturases) that are conserved across plant, animal and bacterial kingdoms, and which are u biquitous in the human diet. Minor amounts of trans - SDA and trans alpha linolenic acid (trans - ALA) are also generated from processing of the novel fatty acids ( Monsanto, 2010b ) . The oils found in MON 87769 soy bean , including the novel ones, are also commonly found in other plants. Oils with substantial amounts of the new fatty acids are already

being processed b y the food and nutrients industries, and are extracted from other plant sources (gamma linolenic acid from borage oil and blackcurrant; SDA from Echium spp.) and thus would not provide novel exposures to workers in the edible oil processing and packaging industry . Monsanto submitted a GRAS Notice (for Foods Generally Recognized as Safe) for MON 87769 soy bean to the FDA (US - FDA, 2009b ) . FDA has no further questions about the characteristics of the oil, and safety of its use in foods (see Appendix A; GRAS Notice No. GRN 000283) ( US - FDA, 2009a) . **4.6 Animal Feed**  The majority of the soybean cultivated in the U.S. is grown for animal feed, and is usually fed as soybe an meal ( Monsant o, 2010b ) . Soybeans intended for animal feed are generally cultivated as commodity products, although there are some consumers demanding specific physical or chemical characteristics to meet specific feed needs ( Monsanto, 2010b ) . In these cases, the soybean meeting those specialized needs are cultivated as a specialty soybean crop. The cultivation practices necessary to maintain identity protection have been previously discussed in Section 2.2.5. Under FFDCA, it is the responsibility of feed manufacturers to ensure that the products they market are safe and properly labeled. Feed derived from MON 87769 soy bean must be in compliance with all applicable legal and regulatory requirements. GE organisms for feed may undergo a voluntary consultation process with the FDA prior to release onto the market. Monsanto initiated the consultation process with FDA for the commercial distribution of MON 87769 soy

bean and submitted a safety and nutritional assessment of food an d feed derived from MON 87769 soy

bean to the FDA on March 23, 2009 (BNF No. 00117) ( Monsanto, 2010b ) . FDA is currentl y evaluating the submission. 4.6.1 No Action Alternative: Animal Feed Under the No Action Alternative, so ybean - based animal feed will still be available from currentl y cultivated so yb ean varieties, both conventional varieties as well as GE soy bean that are no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of87

the Plant Protection Act expressing herbicide tolerance. No change in the availability of these crops as animal feed is expected under the No Action Alternative. 4.6.2 Preferred Alternative: Animal Feed Monsanto has submitted compo sitional and nutritional characteristics of MON 87769 soy bean to APHI S ( Monsanto, 2010b ) . As part of field trials, samples of MON 87769 soy bean and conventional variety A3525 were collected from five different field trial locations during the 2007 - 2008 growing season ( Monsanto, 2010b ) . These samples were analyzed for comparable nutritional components, including proximate (protein, fat, carbohydrates, fiber, ash, moisture), vitamins, amino acids, fatty acids, and the antinutrient factors of so yb ean (which included lectin, try psin i nhibitors, isoflavones, and phytic acid) ( Monsanto, 2010b ) . APHIS has reviewed Monsanto’s results and has concluded that with the exception of the changes in fatty acid composition, the levels of nutrients, anti - nutrients, and secondary metabolites in MON 87769 soy bean are not statistically

different from those likely to be expressed by

conventional varieties . The change in fatty acid composition is not expected to impact the value of MON 87769 soybean as an animal feed , The total fat content of the oil is unchanged which is only about 0.5% (minimum) ( Iowa Soybean Association, 2010 ) . The total saturated fatty acids and polyunsaturated fatty acids in MON 87769 soybean oil are similar to those found in conventional soybean. FDA has agreed that the soybean oil produced with MON 87769 soybean has GRAS status (US - FDA, 2009a) , and thus, these oils are not a risk to animals that consume meal. The desaturase proteins introduced into MO N 87769 soybean are similar to those found in a wide variety of plants, fish and animals, and have been shown to have no toxic or allergenic potential ( Monsanto, 2010b ) . Based on this information APHIS has concluded that a determination of nonregulated status of MON 87 769 soy

bean would have no significant impacts on animal feed or animal health. Overall impacts are similar to the No Action Alternative. **4.7 Socioeconomic Impacts**  4.7.1 Domestic Economic Environment GE soy bean s are cultivated on 93% of the U.S. soy bean acreage ( USDA - ERS, 2010a , 2010b ) . The U.S. acreage of so yb eans planted has varied over time, but the USDA has noted that the acreage dedicated to so ybean has declined in recent years as returns on investment favored corn production (USDA - ERS, 2008 ) . Although acreage has declined, the yi eld per acre has continued to increase (USDA - ERS, 2008 ) . Short - season varieties have provided northern growers with the option to replace wheat crops with soy beans (USDA - ERS, 2008 ) . Soy bean oil lost market share in the food industry earl y in the decade as c onsumers sought vegetable oils that were lower in trans - fatty acids; this trend has slowed with the availability of low - linolenic and high - oleic varieties of soy bean ( USDA - ERS, 2008 ) . The decline in food uses was replaced b y an increase in de mand for commodity- grade so y oil for biodiesel production (USDA - ERS, 2008 ) .88

No Action Alternative: Domestic Economic Environment Under the No Action Alternative, MON 87769 soy bean and its progeny would continue to be regulated under 7 CFR p art 340. Growers and other parties who are involved in production, handling, processing, or consumption of soy bean would not have access to MON 87769 soy bean and its progeny, but would continue to have access to GE that are no longer subject to the regulatory

requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act as well as conventional varieties. Domestic growers will continue to utilize currently available traditional and GE soy bean varieties based upon availability and market demand. Preferred Alternative: Domestic Economic Environment Monsanto anticipates that MON 87769 soy bean will provide a niche product, which in five ye ars, if all demand for SDA were provided by this variety, would equate to about 100,000 acres of M ON 87769 so ybean being grown in the U.S. ( Monsanto, 2010b ) . Monsanto does not anticipate that MON 87769 soy bean would change soy

bean production practices or increase soy bean acreage ( Monsanto, 2010b ) . P roperties of MON 87769 so ybean are not likely to replace substantial amounts of commodity acreage, and will not require significant additional acreage for the new so ybean varieties . New niche food and industrial uses may be found for this oil, but at present, no large requirements for this variety can b e foreseen . Existing soy bean users will remain users of commodity soy oil , and small scale use of MON 87769 so ybean oil may slowly increase in the next five years to that predicted in Monsanto’s market analysis (see Appendix C of this EA). Stewardship of MON 87769 Soy bean Soy bean oil users who may

have concerns about undesirable changes in standard properties of this modified oil have been identified b y Monsanto, and dialogues have begun to solicit both specific issues of importance and to provide these st akeholders with relevant information (Appendix C; Addendum ( Monsanto, 2010b ) ). As noted in Addendum 2 to the MON 87769 soy bean petition, these groups include trade organizations representing oil processors, elevators, grain and oilseed processors, agricultural busines ses and exporters, bakers, and grocery producers. Issues of commingling have been addressed in Addendum 1 (see for example, impacts to commodity

soy bean and meal, changes in oxidative and heat stability , acceptability of sensory properties and allowable ch anges in nutrition facts labeling). The issue of impacts of misdirected MON 87769 soy bean was anal yz ed. Making standard assumptions for the size of a single truck delivery

of an IP soy

bean and for the smallest soy bean processor holding tank, the total SDA content of commodity oil would be 0.8% from a single such delivery . Maximal percentage of SDA in an elevator after misdirection would be 0.03 - 0.16% given standard elevator dimensions. A single truck inadvertently delivering one SDA soy

bean load to a commodity

soy bean ship would lead to SDA content of 0.0008%. In all these cases, the relative amount of the admixture would be extremely small, and as we show next, would not affect key properties of commodity

oil. A number of assessments were made that show ed to what extent mixture of MON 87769 soy bean would affect expected properties of commodity oil. To decrease the oxidative stability (measured b y the oxidative stability index falling below the range of that for commodity89

soy bean), the mixture would require up to 12.5% of MON 87769 so ybean (Figure 1, Appendix C). Monsanto also determined that commodity oil would tolerate up to 15% MON 88769 Soy bean without impact on formation of unacceptable levels of polar materials in commercial fryer conditions (Figure 3, Appendix 2). Commingling of MON 87769 soy bean 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 soy bean oil as a feedstock is that the product has a consistent and s pecific fatty

acid composition ( Cahoon, 2003 ) . The identity protection sy stem detailed above in Subsection 2.2.5, Specialty Soy bean Production, provides controls to ensure that the product traits attained in the field are preserve d up through the ultimate user. Monsanto intends to segregate the crop from commodity soy bean at all stages, from seed production through and including handling , processing and use in a closed loop process, and to oversee a complete product stewardship p lan involving all producers and users ( Monsanto, 2010b ) . Mechanisms to Maintain Product I dentity Monsanto has developed a Closed L oop Stewardship System (CL SS) that will avoid potential impacts to commodity

soy bean oil (Appendix 2). Procedures and processes for MON 87 769 soy bean have been designed for production integrity at all steps of viable seed and grain production, and through storage, grain elevators, oil and meal processors, and downstream entities for product identity assessment ( Appendix 2; Addendum 1 ( Monsanto, 2010b ) ). The CL SS will require terms and conditions for quality management sy stems, quality assurance and quality control. After obtaining international regulatory approvals for MON 87769 soy bean, Monsanto will continue to refine and update the stewardship sy stem for long term implementation. Key

stakeholders will continue to be consulted as stewardship of MON 87769 soy bean continues. Contract buyers of MON 87769 soy bean will be required to identify MON 87769 soy bean beginning with delivery at grain elevators ; sampling for MON 87769 so yb ean grain will be required b y contract for each arriving truckload. Processors and downstream users will use standard oil anal yt ic procedures to provide oil constituent analy sis at critical control points in the CL SS, as w ell as segregation and adherence to standard protocols required by contracts and agreements . In addition to contracts and agreements with Monsanto, product identity at all steps will be maintained because soy

bean sellers and oil processors are motivated t o capture premium prices ; routine adherence to protocols will also serve to maintain product identity . With th ese financial incentives and established procedures , the so ybean industry will observe best management practices, use approp riate identification procedures, employ p roprietary

inventory

s ys tems and ensure traceability

requirements. Using the proposed measures, which would be established by contractual agreements with growers, elevators and processors, Monsanto aims to provide stewardship during all phases of production for stakeholders invested in all uses of soy bean oil. T he vegetable oil industry is experienced at handling multiple IP soy bean ty pes and the oils extracted from them (Appendix 2 and Addendum 1 ( Monsanto, 2010b ) ). Oil processors and users are abl e 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. The90

Monsanto Vistive low - linolenic variety has been available to oil users for six years, and is grown extensively

in 12 states ( Appendix 2, www.vistive.com). Monsanto’s oversight mechanisms for production of Vistive low linolenic oil as well as IP mechanisms used for other identity preserved soy

bean production both have simil arities to the plan described here for product stewardship of MON 877 69 soy bean oil . Monsanto has provided the leadership for production of the low linolenic IP specialty oil, and thus, has multiple years of relevant experience in establishing and maintaining processes of appropriate stewardship for MON 87769 soy bean and its oil products . Monsanto demonstrated that they would work with processors to assure adequate testing methods and quality processes were applied. Market Share/Uses of MON 87769 S oy bean The majority

of soy bean cultivated in the U.S. is grown as a commodity product intended for animal feed. Specific market uses for specialty soybean products generally require adherence to specialty crop practices to preserve identi ty from seed prod uction through harvesting, handling, and processing. A premium is paid to growers and processors for delivering product that meets these desired purity

and quality

standards ( Elbehri, 2007 ; Lee and Herbek, 2004 ; Muth et al., 2003 ; Pritchett et al., 2002 ; Smy th and Phillips, 2002a ; Sundstrom et al., 2002 ) . MON 87769 soy bean is considered a specialty soybean product and will be marketed in accordance with other high - value specialty food crop products ( Monsanto, 2010b ) . To maintain the identity of the product soy

beans , growers cultivating MON 87769 soy bean may potentially

incur increased costs for production and distribution throughout the supply chain (mostly

I P costs). The extent to which MON 87769 soy bean displaces other cultivated varieties cannot be predicted, as market segment is contingent on variety acceptance b y both growers and consumers. Monsanto has developed MON 87769 soy bean to provide an enriched oil source of SDA, which could be made available for food incorporation and for cooking. Commercial plant sources of SDA are limited and production quantities are difficult to ascertain, and fish oil sources of stearidonic and other long chain poly unsaturated fatty

acids may

not be acceptable to customers who do not wish to consume fish or to producers who do not favor the organoleptic or stability properties of fish oil. Of the fish oil used in the U.S., about 14% is used in functional foods (Addendum 1 ( Monsanto, 2010 b ) ), which is one category to which SDA soy

bean will contribute. Monsanto proposes that the availability of SDA soy

bean will allow incorporation of the omega - 3 fatty acid into a wider range of food categories than existing SDA sources ( Monsanto, 2010b ) . The increa se projected through 2016 for omega - 3 oils is 26.6%, about twice the present rate, and Monsanto proposes that the product will get all the increase. Thus, b y 2016, Monsanto expects that MON 87769 soy

bean will be produced on 100,000 acres (Appendix C: Add endum 1 ( Monsant o, 2010b ) ). The MON 87769 so ybean modified oil may also be a candidate oil for use in industrial products , since increased unsaturation may be useful in some applications, but the potential for this use cannot easily be estimated . The main variables that determine outcomes for market share will be consumer acceptance (including that of food and industrial producers) and price of the commodity ( Giannakas and Yiannaka, 2010 ) . The greatest impacts will occur if the price of the novel soy bean oil is relativel y low, and consumer evaluation is highly favorable, which could result in an increasing number of products using oil from MON 87769 soy bean . In this event, increased economic benefit would ensue to producers of the novel oil. Because these variables associated with MON91

87769 soy

bean cannot be determined at present, no definitive conclusions can be made about market share impacts on soy bean oil producers. Potential Market Response to MON 87769 Soy bean Changes in total acreage of specific oilseed crop varieties in response to market demand can be readil y observed. In 1995, the National Sunflower As sociation began developing sunflower varieties to take advantage of pending label requirements for trans fatty acids (NSA, 2006 ) . By 2005, it was estimated that 80% of the U.S. sunflower acreage was planted in NuSunTM, a conventionally

produced high - oleic variety (NSA, 2006 ) . This transition occurred after the food industry conducted extensive studies of food chemistry , supported b y human health assessments (NSA, 2006 ) . The usefulness of low linolenic soybean has allowed growth of the market, from 800,000 acres in 2006 ( Fehr, 2007 ) to a total of 3 million acres since 2005 ( Monsanto, 2010b ) . The low linolenic soy

bean however, has uses as a modified commodity product, and not as a specialty oil that MON 87769 soy bean would supply . The value to the consumer from the changes presented in MON 87769 so ybean is a direct function of the chemical changes associated with the changed concentrations of the fatty acids. The beneficial results of incorporating SDA into consumer products and into finished manufactured foods will be a point advanced b y food marketers. Enough scientific evidence is available for use of EPA, DHA (SDA is a precursor for these in human metabolism) as a food supplement in a conventional food to make certain health claims (see summary of U.S. Agencies statements, ( Council for Responsible Nutrition, 2005 ) ), and these should not exceed FDA statements for reducing the risk of coronary heart disease, “ Supportive but not conclusive research shows that consumption of EPA and DHA omega - 3 fatty acids may

reduce the risk of coronary heart disease” ( US - FDA, 2004 ) . Claims supported by the European Food Safety Authority supported additional claims about the health benefits for maintaining normal eye and brain function, and could be the basis for marketing claims if products were made for export to European markets ( EFSA (European Food Safety Administration), 2011 ) . The size of such domestic markets is difficult to analyze, but gives credence to the market forecast offered by Monsanto for potential use of omega - 3 uses for MON 87769 (Addendum 1 ( Monsanto, 2010b ) ) . This product will have de creased oxidative stabil ity relative to commodity soy bean 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 soy bean are not lower than commodity

soy bean oil ( Table 14 ) so that this parameter do es not improve use as a biodiesel fuel over commodity

soy bean oil because th ese fatty acids may be one factor that improves cold weather performance (AGRA, 2009 ; Graef et al., 2009 ; Knothe, 2005 ; Monsanto, 2010b ) performance . Cetane numbers, which are a measure of the ignition quality of an oi l, will likely be reduced compared to commodity soy bean oil, since increased unsaturation depresses this value (see Table 7, Moser, 2009), and SDA itself and modestly increased linolenic acid both increase unsaturated fatty acids. Lower cetane numbers woul d not offer improvements over commodity

soy bean oil. The costs of developing and managing IP specialty soy bean crops have been identified as a barrier to the market, so price premiums such as noted above are essential for these specialty soy beans to be ad opted ( Pritchett et al., 2002 ) . The cost for entry into the IP sy stem has been92

estimated as high as 25% above the cost of conventional crop p roduction ( Smy th and Phillips, 2002a) . Consumers of specialty crops also have cost burdens associated with these crops. In addition to the costs incurred for specialty crop production, spe cialty crop consumers accrue added IP costs from five general activities: certifying and obtaining ingredients; testing ingredients or final products; separating equipment and facilities; scheduling production and conducting changeover procedures; and con ducting recordkeeping ( Muth et al., 2003 ) . These IP management costs may be offset b y premium value received fo r the crop and the product, as well as increased yields for certain IP varieties. Pritchett reports that specialty soy bean yields are generally

higher than those reported for commodity so ybeans, which he attributes to either the managerial talent of the specialty grower or higher land quality which is recognized and optimized by the grower ( Pritchett et al., 2002 ) . There is no information whether these market entry

costs for cultivation and use of specialty soy bean would be offset by increased yi elds and premium prices for the products of MON 87769 so yb ean . Irrespective of the value added application of oils deri ved from MON 87769 soy bean , adherence to soy

bean IP practices will be essential to ensure that the crop value is preserved. In the alternative, inadvertent use of MON 87769 soy bean by a user desiring an alternative fatty acid composition may

give rise to n egative impacts to those consumers. For example, when poly unsaturated fatty acids are high, rapid oxidation can occur in fried foods and result in undesirable taste and odor (Addendum ( Monsanto, 2010b ) ). Also, the taste commonly associated with fried food is due to the presence of linoleic acid (AGRA, 2009 ) and MON 87769 soy bean will have decreased content . High - oleic acid so y oils are not considered ideal for fried food applications (AGRA, 2009 ) and high levels of linolenic acid contribute to oxidation during fryi ng and over extended storage times ( Rosseli, 1998 ) . If MON 87769 so ybean were inadvertentl y used in high proportions for fried food applications, the resulting food products would likely

be unacceptable . As noted in the Addendum, however, at low levels of admixture of MON 87769 soy

bean with commodity

soy bean oil (up to 15%), no adverse effects can be detected on either oxidative stability or on flavor perception (Appendix C: Addendum 1, ( Monsanto, 2010b ) ) The need to maintain identity and control product characteristics are similar con cerns for industrial applications. O ils with high concentrations of linolenic acid are comparable to linseed oil and are very

desirable in the coatings industry where they

are used to enhance drying of paints, inks, and varnishes ( Cahoon, 2003 ) . SDA and the less saturated linolenic acid, may have decreased oxidative stability (Appendix 2) and thus be valuable in this ty pe of application. Vegetable oil pol yols formed via epoxides are used in production of polyurethanes, When veg etable oils contain high levels of specific unsaturated fatty acids, epoxidized soy bean produced oils can be produced that lead to higher quality chemicals with more homogeneous character ( Cahoon, 2003 ) . While the inadvertent subs titution of one specialty oil for another specialty oil is highly

unlikely , the results of such an accidental substitution in the industrial sector may nonetheless be substantial. If the IP practices do not maintain the identity of MON 87769 soy

bean and e ither conventional so y oil or other specialty oils, desired oil composition would be compromised and the product would not meet its specifications. Those entities crushing or using oil from MON 87769 soy bean will be required under Monsanto’s stewardship pl an to be continually

monitoring fatty acid content of oil, both upon arrival and after processing. Those oil industry

entities that do not purchase or expect MON 87769 soy bean derived oil will93

also need to monitor fatty acid content of oil products, which for standard quality assurance programs would be done under any ci rcumstance, but also because various specialty soy bean oils besides MON 87769 are also present in the marketplace, which could also have impacts on fatty acid content. Id entity preserved product such as low - linolenic varieties provide the grower with a premium price as high as $1.25 per bushel ( Conley et al., 2008 ) but more recentl y have declined to 50 - 60 cents per bushel ( Wallaces Farmer, 2010 ) . In 2005, when Monsanto introduced the low - linolenic soy bean “Vistive” variety , food producers such as Kellogg noted that there was a high demand and significant shortage for soy oils with these traits ( Woznicki, 2005 ) . MON 87769 soybean market share will be contingent on a demonstrated price and high yi eld potenti al as well as consumer and producer preference to other modified fatty acid so yb ean varieties. Net income differentials cannot be projected , since the net income of so yb ean producers growing conventional soy

bean is not easily

predicted (see regional diff erences in years 2009 - 10) (USDA ERS, 2010e ) . However, as Monsanto anticipates that MON 87769 soy bean would be cultivated as a specialty

crop under an IP sy stem , resulting domestic socioeconomic impacts are expected to be similar to the N o A ction A lternative . Similar to other specialty crops currentl y being grown under IP s ys tems, resulting economic benefits are contingent on adherence to IP practices at all stages of MON 87769 soy bean cultivation and production. 4.7.2 Trade Economic Environment Although so ybean oil constitutes only a small percent of soy

bean weight (approximately 19%), soy bean 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 source of vegetable oil worldwide (USDA - ERS, 2010e ) . In2005, however, palm oil overtook soy

bean oil in volum e of production; palm oil and rapeseed oil (canola) production are expected to continue to grow over the next few ye ars (USDA - ERS, 2010e ) . In 2009, the U.S. exported 1.3 billion bushels (34.9 million metric tons) of soy bean, which accounted for 46% of the world's soy

bean exports ( Soy Stats, 2010g ) . In total, the U.S. exported $16.5 billion U.S. dollars (USD ) worth of soy bean and so yb ean products in 2009 ( Soy Stats, 2010b ) . China is the largest export market for U.S. soy bean with purchases totaling $9.2 billion. Mexico is the second largest export market with sales of $1.3 billion in the same year ( Soy Stats, 2010b ) . Other significant markets include Japan and the EU. The global demand for soy beans is expected to increase by a full third over 2010 consumption in the next ten years, with China accounting for 80% of the expected increase in total demand ( FAPRI, 2009 ; Hartnell, 2010 ) . China and India are predicted to import 46% of the total soy bean market by

2018/2019 ( FAPRI, 2009 ) . The USDA has predicted that U.S. exports will remain flat during much of this period, as a result of increase in domestic consumption and competition from South America ( FAPRI, 2009 ; USDA - ERS, 2009 ) . To a certain extent, competition with South American producers will be offset b y increased demand from China ( FAPRI, 2009 ) . The USDA predicts that the U.S. share of this export market could potentially de cline from the current 46% to 30% at the end of the decade ( FAPRI, 2009 ; USDA - ERS, 2009 ) . It is also noted that as a result of higher prices for vegetable oils as a result of increased demand for food use as well as for biodiesel and other industrial uses, previously uncropped land in94

Brazil, Indonesia, and Malaysia are being brought into production for soy bean and palm oil (USDA - ERS, 2009 ) . This will increase global competition for export marke t share. In come benefits from cultivation of herbicide tolerant soy beans have been substantial. Global farm income has been estimated to have increased over 6% in 2007 as a consequence of adopting these varieties ( Brookes and Barfoot, 2010 ; Hartnell, 2010 ) . Global gains from adoption of herbicide - tolerant soy

beans 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 . soy

bean export competitiveness. In Argentina, for example, the cost of herbicide - tolerant so ybean production is substantially lower than U.S. costs because Monsanto was unable to patent the technology in Argentina ( Brookes and Barfoot, 2010 ) . As a consequence, Argenti nian growers are able to save seed and not pay technology

fees or ro yalty fees on farm - saved seed ( Brookes and Barfoot, 2010 ) . No Action Alternative: Trade Economic Environment Approximately

93% of the soy

bean varieties currently

cultivated in the U.S. are GE varietie s (USDA - ERS, 2010a , 2010b ) . All these GE so ybean varieties are herbicide resistant. Specialty soy beans comprise approximately 12% of the soybean acreage ( MSA, 2009 ) . U.S. soy beans will continue to play

a role in glob al so ybean production, and will continue to be a supplier in the international market. Under the No Action A lternative, there would be no changes t o the existing soy bean market. Preferred Alternative: Trade Economic Environment To support commercial introduction of MON 87769 soy bean in the U.S., regulatory submissions will be made b y 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, 2010 b ) . These will include submissions to a number of foreign government regulatory

authorities, including: Ministry of Agriculture, People’s Republic of China; Japan’s Ministry of Agriculture, Forestry , and Fisheries (MAFF ) and the Ministry of Health, L abor, and Welfare (MHLW); the Canadian Food Inspection Agency (CFIA) and Health Canada; the Intersectoral Commission for Biosafety of Genetically Modified Organisms (CIBIOGEM), Mexico; the European Food Safety Authority

(EFSA); and the regulatory authoriti es in other soy bean importing countries with functioning regulatory s ys tems. As appropriate, notifications of importation will be made by the petitioner to importing countries that do not have a formal approval process. MON 87769 soy

bean is intended to be cultivated as a specialty GE so yb ean variety and the SDA soy bean oil will be produced and processed using a closed loop stewardship sy stem to capture the food quality

value of the oil ( Monsanto, 2010b ) . The cultivation of MON 87769 soy bean is not expected to result in an increase in the total acreage devoted to so ybean cultivation, although the allocation of acreage to specialty soy bean cultivation could increase contingent upon market demand. As with the No Action Alternative, U.S. soy beans will continue to play a role in the global so ybean market.95

To the extent that the modified fatty acid so ybean oil derived from MON 87769 soy bean achieves market acceptance, it is conceivable that this soy bean - based oil could displace other fish oils and small scale production of exotic SDA vegetable oils in the international market. Products potentially

displaced b y MON 87769 soybean oil may include crops producing oils from such plants of the genera Echium and Ribes (black current). Although MON 87769 soy bean oil may not be use d in food products to the exclusion of existing products, at least some diminution of other oils from commodity soy bean, canola, corn and so forth may be marginall y displaced in the production of food products augmented with the new so ybean oil. Consistent with the potential increase in international demand for this specialty oil product, as well as price competitiveness, a determination of nonregulated status of MON 87769 soy bean may have a positive benefit on U.S. exports as soy oil based on this product increases soy bean oil sales . The international market share of MON 87769 soy bean as specialty variety

is contingent on global vegetable oil market requirements, food processor acceptance, consumer preference, demonstrated availability of the product, and price competitiveness ( Monsanto, 2010b ) . However, with an inability to predict the size of these variable inputs, APHI S cannot reliably foresee the outcome for an increase in world market share of soy bean resulting from planting of this variety. Global sensitivities t o GE products, including international restrictions on import of GE products and inability

of the petitioner to gain local approval for cultivation or importation, will continue to impede trade with those countries. These challenges to international trade in GE products are already in place. Restrictions on international trade in GE products, including MON 87769 soy bean , are unlikel y to change with a determination of nonregulated status of MON 87769 soy bean . A determination of nonregulated status of MON 87769 soy bean will not adversel y impact the trade economic environment and could potentially enhance it through the subsequent demand for the SDA MON 87769 soy bean line and its oil products. The MON 87769 soy bean follows trends in the continuing developm ent of specialty soy beans with modified fatty acid profiles. The trade economic impacts associated with a determination of nonregulated status of MON 87769 soy

bean are anticipated to be very similar to the No Action Alternative. 4.7.3 Social Environment The soc ial environment evaluated in this subsection relates to the general soybean farm, as well as the individuals or workers employed by the businesses potentially impacted by this product, including food processers and industrial users. No Action Alternative: Social Environment Under the No Action Alternative, there would be no changes from the status quo impacts on the social environment surrounding so ybean farming, food processing, or industrial uses. The cropping and marketing decisions currently made by so ybean growers are unlikely to change with the selection of this alternative. Preferred Alternative: Social Environment96

MON 87769 soy

bean is not intended to confer any competitive advantage in terms of weed management or to extend the range of cultivation o utside of existing cultivation areas. Monsanto expects that MON 87769 soy bean will be cultivated as a specialty crop, with the SDA soybean oil produced and processed under existing identity protection systems to capture the food quality value of the oil ( Monsanto, 2010b ) . Consistent with the expectations that this variety is to be cultivated as a specialty crop, a determination of nonregulated status of MON 87769 soybean is not expected to result in an expansion of the number of so ybean acres, since oil from the varie ty will likely

replace existing oils from soy bean on a highl y limited scale. Soybean acreage is expected to remain stable, and overall impacts relative to the total soy bean market s ys tem are similar to the No Action Alternative. To the extent that MON 8 7769 soy bean is accepted by

producers and consumers, MON 87769 soy bean has the potential to displace other specialty soy bean varieties, but given the expected market growth of the variety , is expected to have no significant impact. Only 0.5% of the existi ng acres of so yb ean in the a ffected area are likely to be planted to the MON 87769 soy bean . Those growers currentl y cultivating specialty soy bean varieties have already invested in equipment and practices to maintain the identity of the product from seed through harvest and processing and would not be impacted b y this change. To the extent that a grower currently cultivating commodity

soy bean elects to cultivate MON 87769 soy bean , that grower will need to invest in handling equipment and management practi ces to capture and preserve the food quality value of the oil. Growers adopting specialty varieties already

make such investment decisions based upon perceived value and return on investment ( Iowa State University, 2008 ) . The soy bean market also includes seed production, equipment manufacturers, handlers, and producers. Monsanto’s analy sis of agronomic characteristics did not identify any differences between MON 87769 soy bean and conventional varieties ( Monsanto, 2010b ) . Monsanto expects that MON 87769 soy

bean would be cultivated, handled, and processed consistent with existing identity p rotection practices and s ys tems ( Monsanto, 2010b ) . Other than equipment required to maintain identity

protection, no specialized equipment is required to cultivate, handle, or process MON 87769 soy

bean . Food processors potentially impacted b y MON 87769 soy bean include those parts of the industry using so ybean 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 sy stem (Addendum 1 ) ( Monsanto, 2010b ) . Because other modified oil products are already present in the commodity oil market and routinel y handled by processors using standard industry

processing methods and equipment, no new processes or equipment are required to introduce MON 87769 soy bean . Thus, workers in these areas are not likely to be impacted b y any major alterations of so ybeans or of qualities of soybeans processed. Monsanto has evaluated the market and trade applications of MON 87769 soy bean , and has determined that this product will be used in a variety of uses, including margarine, shortenings, salad dressings, ready to eat foods , baked goods and a variety of other products (Addendum) ( Monsanto, 2010b ) . In the event that MON 87769 soy bean is introduced into a commodity oil unintentionally

at the level of a misdirected truckload of soy bean, or other unit delivery at a higher level of processing, the consequent mixture would be less than 15%, at which level, no97

impacts on food ingredient labels or nutrition facts panels or changes to oxidative stability or food sensory

properties would result (Addendum ) ( Monsanto, 2010b ) . Potential impacts to industrial users of so ybean products are similar. Existing identity protection measures are already in place to allow industrial users to manage feedstocks and products for specific applications and needs ( Smy th and Phillips, 2002a ; Sonka et al., 2004 ) . No new equipment or practices are required to incorporate MON 87769 soy bean into this industrial market. Howev er, for industrial users that require close tolerances in the ratios of fatty acid to ensure product quality , continuous monitoring of properties of input oils may be necessary . This scrutiny may already have been enhanced, given that the industry has inc reasingl y begun to encounter and already needs to manage an increasing range of different soy - based feedstocks, ranging from ultra - low linolenic acid varieties, through and including feedstock oils for blending from other crops, such as high - oleic and high linolenic varieties that have various uses ( Cargill, 2011 ; USB, 2010b ) . Thus, APHI S does not expect that changes to the social environment including workforce will be altered b y entry of this variety into the soy bean market. Consistent with the above assessment of potential impacts to the growers, and workforce in the food processing and industrial use categories, the impacts of a determination of nonregulated status of MON 87769 soybean are expected to be the same as the No Action Alternative.98

**5 CUMULATIVE IMPACTS**  A cumulative impact may be an effect on the environment which results from the incremental impact of the p roposed a ction when added to other past, present, and reasonably foreseeable future actions. For e xample , the potential effects associated with a determination of nonregulated status of a GE crop in combination with the future production of crop seeds with multipl e traits that are no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act (i.e., “stacked” traits) , including drought tolerance, herbicide tolerance, and pest resistance , would be consider ed a cumulative impact . **5.1 Assumptions Used for Cumulative Impacts Analysis**  Specialty soy beans are cultivated to meet specific consumer needs. MON 87769 soy bean is anticipated to be cultivated as another specialty soybean, offering growers and consumers an o ption for an omega - 3 fatty acid easil y converted by human metabolism to desirable fatty acids, EPA and DHA. Herbicide tolerant so ybean is already extensively deployed in the seed market, as are a variety

of specialty

fatty acid ratios in other vegetable oil sources. No additional potential cumulative impacts to the commodity soy bean market or the specialty soy bean market can be reliabl y anticipated as a result of a determination of nonregulated status and cultivation of MON 87769 soy

bean . MON 87769 soy

bean will be a readily

produced source of omega - 3 fatty acids, but not the only one, since there are other specialty vegetable oils that also provide SDA, such as the minor crops, borage, Echium spp. and blackcurrant. MON 87769 soy bean successes in replacing these other high - oleic vegetable oils will be contingent upon producer and customer acceptance, availability of the product, and price. Monsanto estimates that the market for marine oils in the U.S. is 26,477 metric tons, and that this market and an annu al increase in demand of 13.4% will provide the opportunity

for use of this product. Stacked varieties of so yb ean, those crop varieties that may contain more than one trait, are currentl y found in the marketplace and in agricultural production. In the event APHI S reaches a determination of nonregulated status, MON 87769 soy bean may be combined with non - GE and GE soy bean varieties by

traditional breeding techniques. There is no assurance that MON 87769 soy bean will be stacked with any particular GE soy

bean 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. APHI S’ regulations at 7 CFR Part 340 do not provide for Agency oversight of GE soy

bean varieties no longer subject to the requirement of Part 340 and the plant pest provisions of the Plant Protection Act, nor over stacked varieties combining these GE varieties, unless it can be positively shown that such stack ed varieties were to pose a likely plant pest risk. Predicting all potential combinations of stacked varieties is hy

pothetical and purely

speculative. **5.2 Cumulative Impacts: Acreage and Area of Soybean Production**  Cumulative effects of a determination of nonre gulated status of MON 87769 soy bean are unlikely . While APHI S expects that this variety will be stacked with gl yphosate tolerance or other herbicide tolerance, as is a large percentage (93%) of other so yb ean crops in the U.S., it99

will not lead to any

signi ficant changes in the specifics of so ybean production. Neither the No Action Alternative nor a determination of nonregulated status of MON 87769 soy bean are expected to directl y cause an increase in agricultural acreage devoted to soybean production or tho se soy bean acres devoted to GE soy bean 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 b y 2016), will have no substantial impact on general soy bean production. The availability of MON 87769 soy

bean is not expected to change the cultivation areas for so yb ean production in the U.S., and there are no anticipated changes to the availability

of GE and non - GE so ybean varieties on the market under either alternative. **5.3 Cumulative Impacts: Agronomic Practices**  Monsanto has stated that MON 87769 soy bean would be stacked with either gl yphosate or other available nonregulated herbicide resistance traits ( Monsanto, 2010c ) . Monsanto has also indicated that gly

phosate will be the continuing cornerstone of any multiple herbicide stack, with additional resistance complementing the activity , or allowing additional flexibility in designing weed control ( Monsanto, 2010a) . The adoption of herbicide tolerance traits comp lements conservation tillage practices by allowing farmers to substitute herbicide application for some tillage operations as a weed management practice (NRC, 2010 ) . Herbicide usage trends since the adoption of GE crops are the subject of much d ebate, with initial assessments indicating a decline in herbicide use in the earl y ye ars of herbicide - tolerant crop production ( Carpenter et al., 2002 ) that some argue was then followed b y an increase in the volume of herbicide usage as the technology

spread ( Benbrook, 2009 ) ). Others report a continuing decline in herbicide use with the adoption of GE crops ( Fernandez - Cornejo and Caswell, 2006 ) , or relative stability in the amount of herbicide active ingredients applied to soy beans ( Brookes and Barfoot, 2010 ) . The contradictory

findings have been attributed to the different measurement approaches used by researchers, how different factors affecting pesticide use such as weather or cropping patterns were controlled for, and how the collected data was statistically analyzed (NRC, 2010 ) . Itis anticipated that herbicide use will continue the trends noted by Beckie and Tardif ( Beckie and Tardif, 2012 ) associated with the wide use of gl yp hosate - tolerant so yb ean along with crops stacked with multiple herbicide resistances as they are available or become so, and that alternative herbicides will m ore frequently be used sequentially , or in mixtures, or as required in crop rotations, to manage herbicide resistant weed populations. Although weed control with excessive reliance on only gl yphosate has possibly favored development of gl yphosate resistance, such resistance was not an inevitable consequence of the use of gly phosate resistant crops, but mainly a consequence of failing to use total weed control management plans ( Shaner et al., 2012 ) and indeed, use of any herbicide can lead to weed resistance (Heap, 2012). Growers have been provided with an array of tactics to deal with either existing resistant weeds, or to deter the development of these b y seed providers ( Monsanto, 2012 ) or b y local university extension specialists. These recommendations for glyphosate resistant soy

bean varieties include crop rotations, use of preplant residual herbici des, and tank mixes with residual or post emergent herbicides. The National Research Council (NRC, 2010 ) summarized strategies that may be used by

growers to avoid development of gl yphosate - resistant weeds to include:100

 Developing a diversified weed management program using herbicides with different modes of action, either concurrently or sequentially (NRC, 2010 ) .  Using the full recommended herbicide rate and proper application timing for the most difficult to c ontrol weeds in the field (NRC, 2010 ) .  Scouting the fields after herbicide application to ensure that control has been achieved and to discourage weeds from reproducing or proliferating vegetativel y (NRC, 2010 ) .  In corporating cultural p ractices such as cultivation, tillage and crop rotation, where appropriate (NRC, 2010 ) . Currently , thirteen weeds have been identified as gly phosate - resistant in the US ( Heap, 2012 ) , with seven of these weeds identified as difficult to control weeds in so ybean: common ragweed ( Ambrosia artemisiifolia ), common waterhemp ( Amaranthus rudis ), giant ragweed ( Ambrosia trifida ), horsetail (marestail) ( Conyza canadensis ), Italian ryegrass ( Lolium multiflorum ), Johnsongrass (S

orghum halapense ), and Palmer amaranth ( Amaranthus palm eri ) ( Benbrook, 2009 ) . Because the U.S. EPA is responsible for regulating the sale, distribution and use of pesticides, including pesticides that are produced by an organism through techniques of modern biotechnology , USDA has no regulatory authority over the subsequent use of herbicides on herbicide tolerant plants that may be stacked with the MON 87769 trait. Besides gl yphosate, so yb ean growers have had other herbicide - tolerant variety options for soy bean production; two mechanisms for gl yphosate resistance are offered to growers: insensitive target enzy

me and increased metabolism. In addition, LibertyLi nk® Soy bean with glufosinate ammonium tolerance is available from numerous seed dealers (e.g., Stine Seed), as are STS soy

beans, a conventionally

derived resistance to ALS herbicides, which may be stacked with other resistance traits (e.g., Asgrow Seed). These options allow growers to reduce dependence on gl yphosate, especially if gl yphosate - resistant weeds are an important issue. Volunteer so ybean is normally not a concern. So ybean is not winter hardy, and existing mechanical and chemical methods are available to manage the occasional volunteer soy bean. Herbicides are available to control volunteer so ybeans in corn, and wheat (above). These herbicides are suitable for post - emergent control of volunteer so ybean. The challenges which growers face in managing gl yphosate - resistant weeds is also not expected to differ between MON 87769 soy

bean stacked with gly

phosate resistant trait and other gl yp hosate - tolerant varieties, and similar herbicides would be used in either crop for such weeds. A determination of nonregulated status of MON 87769 soy bean 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 soy bean varieties (either herbicide tolerant ones, when stacked with an herbicide tolerant trait, or non - GE soy bean when not stacked with an herbicide tolerant trait) in terms of agronomic characteristics, and cultivation practices would closel y follow the herbicide tolerant GE or non - GE variety ( Monsanto, 2010b ) . It is anticipated that herbicide use will continue the trends associated with the wide adoption of gl yphosate - tolerant soy bean and the emergence of gl yphosate - resistant weeds , but that growers are increasingl y cognizant of the risks of failing to respond to possible development of gl yp hosate resistance (in a 2009 telephone survey

89% of growers were taking steps to minimize develo pment of resistance ( WSS A, 2010 ) ). APHIS has determined that there are no past, present, or reasonabl y101

foreseeable actions that would aggregate with effects of the proposed action to effect changes in crop rotation, and pesticide use. **5.4 Cumulative Impacts: Soybean Seed**  **Production** Based on current acreage trends, GE so ybean varieties will likely continue to dominate the soy bean market. Since 2007, the GE varieties of soy bean have comprised 91 to 93% of the U.S. soy bean acreage. Changes in the agronomic practices and loc ations for soybean seed production using MON 87769 so ybean are not expected. The availability of MON 87769 soybean will not change cultivation areas for so ybean seed production in the U.S.; no cumulative effects have been identified for this issue **5.5 Cumulat** **ive Impacts: Organic Soybean Production** A determination of nonregulated status of MON 87769 soy bean is not expected to change the market demands for GE soy bean or soy

bean produced using organic methods. A determination of nonregulated status of MON 87769 soy bean will add another GE soy bean variety to the conventional soy

bean market. Based upon recent trend information, adding GE varieties to the market is not related to the ability of organic production sy stems to maintain their market share. **5.6 Cumulative I**  **mpacts: Specialty Soybean Production** A determination of nonregulated status of MON 87769 soy bean is not expected to change the market demands for GE soy bean or non - GE so ybean produced using specialty systems. MON 87769 soy

bean is expected to be cultivated as a specialty soybean consistent with identity preserved practices. From Monsanto’s market analy sis for needs of the soy bean product, in five ye ars the acreage produced will likely be onl y 1% of total specialty soybean acreage, assuming that specialty

s oy bean stay s at current estimates of 12% of commodity soy bean production ( Monsanto, 2010b ) . Based on demonstrated agronomic characteristics and cultivation practices, and because the market share of specialty so ybean varieties is unlikely to substantially change follo wing the introduction of MON 87769 so ybean, APHI S has determined that there are no past, present, or reasonably

foreseeable changes that would impact specialty soy bean producers and consumers. No cumulative effects have been identified for this issue. **5.7 Cumu**  **lative Impacts: Water Resources** Monsanto proposes that MON 87769 soy bean will be stacked with a gl yphosate tolerant trait or potentially

with other herbicide tolerant traits no longer subject to the regulatory requirements of Part 340 and the plant pest provisions of the Plant Protection Act or with both ( Monsanto, 2010c ) . Current application rates of gl yphosate for weed control with MON 87769 soy bean are not expected to change. Although gl yphosate is very soluble in water, it is strongl y adsorbed to soils; consequently, gl yphosate is unlikel y to leach into groundwater or surface water runoff following applicati on ( Gies y et al., 2000 ; US - EPA, 1993b ) . However, Coupe et al. ( Coupe et al., 2011 ) has shown that in agricultural basins with high gl yphosate use rates, high ov erland runoff rates, and low flow through soil, gly

phosate can be readil y detected in surface waters. Rel yi ng on toxicological data, bioaccumulation and biodegradation studies, and acute and chronic tests on fish and other102

aquatic organisms, EPA however, has determined that “the potential for environmental effects of gl yphosate in surface water is minimal” (US - EPA, 1993b ) . No cumulative effects on water use have been identified associated with a determination of nonregulated status of MON 87769 soy bean . A determination of nonregulated status of MON 87769 soy

bean will not change the water use and irrigation practices used in commercial soy bean production. **5.8 Cumulative Impacts: Soil Quality**  APHI S has not identified any cumulative effects to soils. Comprehensive phenoty pic, agronomic, and ecological assessments conducted by the petitioner for MON 87769 soy bean did not find significant differences between MON 87769 soy bean and control soy

beans for these characteristics ( Monsanto, 2010b ) . The few differences that were identified were typically small, site specific, and unlikely to be biologicall y meaningful. Event MON 87769 soybean required the same soil, fertilizer, water and pest management practices as non - GE so ybean ( Monsanto, 2010b ) . Consequently , the phenotypic, agronomic, and ecological data presented b y Monsanto ( Monsanto, 2010b ) support the conclusion by APHIS that MON 87769 soy bean will not significantl y modify

soil characteristics associated with conventional soy bean pro duction practices. If MON 87769 so ybean is stacked with herbicide tolerance traits, persistence of pesticides in soil may be modulated by

cultivation (see review of runoff potential in conservation tillage versus no - till and runoff potential ( Warnemuende et al., 2007 ) ). The gl yphosate tolerant trait would likely be stacked with this variety, and so gl yphosate w ould be the predominant post - emergent herbicide applied to MON 87769 soy bean, as it is with other gl yphosate tolerant so ybean. Gly phosate has been shown to rapidly dissipate from most agricultural ecosy stems across a wide range of soil and climatic conditions, with a median soil half - life (the time it takes for half of the gl yphosate to dissipate in the soil) of 13 day s ( Giesy et al., 20 00 ) . A survey

reported by Borggard and Gimseng ( Borggaard an d Gimsing, 2008 ) noted soil half - lives ranging from 1.2 to 197 day s, depending on a wide range of chemical and phy sical parameters of soil. If MON 87769 were to be stacked with the gl yphosate tolerant trait, this would present certain environmental bene fits over other herbicides that may be used for control of weeds in non - GE soy bean production ( Cerdeira and Duke, 2006 ; Hin et al., 2001 ) . Pesticide products approved for application to emerged weeds normally are applied with surfactants. Surfactants increase the permeability of the weed foliage to increase the foliar uptake of gl yphosate and thereb y improve the efficacy of the herbicide ( Stock and Holloway , 1993 ) . Polyethox yl ated alkyl amine (POEA) is the predominant surfactant used in formulated gl yphosate products. Glyphosate and the POEA surfactant have similar soil dissipation rates and the same primary

route of dissipation, i.e., microbial degradation ( Gies y et al., 2000 ) . The halflife of POEA in soil is estimated to range from 7 to 14 day s ( Gies y et al., 2000 ) . On that basis, the POEA surfactant i s expected to behave similarly to gl yphosate in field soil, and an increase in residual soil concentrations (accumulation) of the POEA surfactant is not anticipated. Because MON 87769 soybean when stacked with gl yphosate or other herbicide tolerance does not differ in its agronomic requirements from conventional soy bean or other GE varieties103

expressing gl yphosate tolerance, agronomic practices associated with soil and land use are not expected to change with the availability of this new plant product. Bas ed on these findings, and because the amount of soy bean grown in the U.S. is unlikely to change by

the introduction of MON 87769 soy

bean, APHI S has determined that there are no past, present, or reasonabl y foreseeable actions that would aggregate with effe cts of the proposed action to impact soil. **5.9 Cumulative Impacts: Air Quality**  APHI S has not identified any cumulative effects for this issue. The use of MON 87769 soy bean in commercial so ybean production is not expected to cause any cumulative effect on air quality because APHI S does not anticipate any changes in soy

bean production practices or an expansion of soy bean acreage as a result of a determination of nonregulated status of MON 87769 soy bean. The consequences of the Preferred Action Alternative on co mmercial so yb ean production and acreage are the same as for the No Action Alternative. **5.10 Cumulative Impacts: Climate Change**  APHI S has not identified any cumulative effects for this issue. The use of MON 87769 soy bean in commercial so ybean production is not expected to cause any cumulative effect on climate change because APHIS does not anticipate any changes in soy bean production practices or an expansion of soy

bean acreage as a result of a determination of nonregulated status of MON 87769 soy

bean. The cons equences of the Preferred Action Alternative on commercial so ybean production and acreage are the same as for the No Action Alternative. **5.11 Cumulative Impacts Animal Communities**  Soy bean may be used b y 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 soy bean grain. Monsanto data for food and feed safety has established substantial evidence that the MON 87769 soy bean is safe for long term consumption, since no acute imp acts could be identified. Dietary exposure to the two new proteins expressed by MON 87769 is not a risk to human or animal health; the proteins are not toxic and fatty acids produced are common in the environment, produced b y some other plants, fish and al gae. There are no composition differences between this and conventional soybean, except for increased production of SDA, gamma linolenic acid and some expected decreases in other fatty acids. No differences in insect feeding damage to MON 87769 soy

bean and the comparator, conventional variety A3525 were observed over two ye ars (Table I - 5 and I - 6) ( Monsanto, 2010b ) . No significant cumulative impacts to animals or insects that feed on so yb ean expressing MON 87769 soy bean would follow a decision to choose the Preferred Alternative. **5.12 Cumulative Impacts: Plant Communities**  If MON 87769 so ybean is stacked with the gl yphosate tolerance trait growers would continue to use gl yphosate predominately for post - emergent weed control. The Roundup Ready® soy bean sy stem has become the standard weed control program in the U.S. cultivation of soy bean. Approximately

92% of the U.S. soy

bean acreage is planted in Roundup Ready® soy bean varieties. Monsanto anticipates that MON 87769 soy bean will not replace commodity ty pe gl yphosate - tolerant soy

bean varieties previousl y found to no longer be subject to the requirement104

of Part 340 and the plant pest provisions of the Plant Protection Act. Rather, MON 87769 soy bean will remain a minor product with limited acreage. While any broad spectrum herbicide application has the potential to impact off - site plant communities, the impacts of planting MON 87769 soy

bean expressing gl yphosate tolerance will not be novel or extensive. Accordingl y, the cultivation of MON 87769 soy bean is not expected to resul t in an increase in the application of gl yphosate or changes in herbicide treatments when compared with existing gl yphosate - tolerant soy bean varieties that are no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act. **5.13 Cumulative Impacts: Gene Flow and Weediness**  One introduced gene expected to be stacked in the MON 87769 soy bean is the cp4 epsps gene, which confers tolerance to the herbicide gl yphosate. This gene is commonly found in other Roundup Ready® crops ( USDA - APHIS, 2010c ) . No data have been presented to suggest that the incorporation of the cp4 epsps gene allows so ybean to survive and reproduce without human intervention (USDA - APHI S, 2010c ) . The soy bean industry

has identity

protection measures in place to restrict pollen movement and gene flow between so yb ean fields through the use of isolation distances, border and barrier rows, the staggering of planting dates and various seed handling, transportation, and ginning procedures ( Bradford, 2006 ; NCAT, 2003 ; Sundstrom et al., 2002 ) . As a specialty soybean variety, MON 87769 so ybean would be cultivated within these identity protection practices. In addition, there is no evidence that horizontal gene transfer and expression of DNA occurs between so yb ean 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 soy bean than it is for other non - GE or GE cultivars. Inits PPRA , APHI S assessed the weediness potential of MON 87769 soy bean 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 - APHI S, 2010c ) . In each case, the changes introduced in the MON 87769 soy bean 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 woul d occur from a determination of nonregulated status of MON 87769 soy bean . From data presented b y Monsanto on those agronomic characteristics likely to be associated with a change in weediness of the crop, there were no differences that were found between the host soy bean and the genetically

engineered MON 87769 soy bean (USDA - APHI S, 2010c ) ; APHI S concluded that potential for weediness of MON 87769 was unlikely . **5.14 Cumulative Impacts: Microorganisms**  Cultivation of MON 87769 soy bean is highl y unlikely

to have direct toxic effects on microorganisms. The gly phosate tolerant trait would likely be stacked with this variety , and therefore gl yphosate would likely be the predominant post - emergent herbicide a pplied to MON 87769 soy

bean, as it is with other gl yphosate tolerant soy bean. Microorganisms produce aromatic amino acids through the shikimate pathway , similar to that in plants (USDA - FS, 2003 ) . Because gl yphosate inhibits this pathway , it could be expected that gl yphosate would be toxic to microorganisms. Gly

phosate use has been identified as potentially causing increases in certain105

disease - causing microbes ( Fernandez et al., 2009 ; Kremer and Means, 2009 ) . Reported increases in infections in cereal crops from pathogenic soil fungi have in some cases been determined to be more closel y relat ed to reduced tillage and continuous cropping using herbicide - tolerant crops, whereas in others, application of gl yphosate correlated with increased bacterial species ( Fernandez et al., 2009 ) . The U.S. Forest Service, while acknowledging that in some cases, increases in soil pathogens following gl yphosate treatment can be detected, “there is no indi cation that the transient enhancement in populations of soil fungi or bacteria will result in any substantial or lasting damage to soil ecology” (USDA - FS, 2003 ) . Because any microorganism is already extensively exposed to glyphosate, it is unlikely that any new organisms would be impacted. Therefore, the likelihood of adverse cumulative effects on microorganisms following the introduction of MON 87769 soybean is minimal. **5.15 Cumulative Impacts: Biodiversity**  Cultivation of MON 87769 soy bean is highl y unlikely

to have direct toxic effects on non - target animals and microorganisms and is likely to be neutral to biodiversity compared with conventionally

managed GE and non - GE so yb ean. Because any nontarget plants are already extensively

exposed to gly

phosate, it is unlikely

that any new plants will be impacted. Therefore, the likelihood of adverse cumulative effects on non - target organisms and biodiversity following the introduction of MON 87769 so ybean is minimal. The use of geneticall y m odified soy bean such as MON 87769 soy bean when stacked with g ly phosate tolerance may improve biological diversity by providing growers the opportunity to use conservation practices. Incorporation of herbicide tolerance in the crop facilitates the grower adoption of conservation and no - till strategies, improved soil porosity , enhancing soil fauna and flora ( CTIC, 2 010a ) , increasing the flexibility of crop rotation, and facilitating strip cropping ( Fernandez - Cornejo et al., 2002 ) , each of which contributes to the health of the faunal and floral communities in and around soy bean fields thereby

promoting biodiversity ( Palmer et al., 2010 ; Sharpe, 2010 ) . Based on available scientific data, the changes in fatty acid composition associated with MON 87769 soy

bean are not expected to directly or indirectly

affect plants, animals or biodiversity . The genes responsible for the change in fatty acid compositio n are endogenous to the soy bean and are thus already a part of the so ybean cultivation environment. The U.S. EPA has reviewed the safety of the CP4 EPSPS protein and has established a tolerance exemption for the protein and the genetic material necessary for its production in or on all raw agricultural commodities ( (US - EPA, 1996 ) ; 40 CFR§174.523). The lack of any documented reports of adverse effects since the introduction of other Roundup Ready® crops in 1996 suggests the safety of its use. The CP4 EPSPS protein expressed in MON 87769 so ybean is the same as that previously reviewed by the U.S. EPA, accordingl y, MON 87769 so yb ean is anticipated to be safe f or animal consumption with regard to the cp4 epsps gene. APHI S has determined that there are no impacts from past, present, or reasonably foreseeable actions that would aggregate with effects of the proposed action to create cumulative impacts or reduce th e long - term productivity or sustainability of any of the resources associated with the ecos ys tem in which MON 87769 soy bean is planted (USDA - APHI S, 2010c ) .106

**5.16 Cumulative Impacts: Human Health**  5.16.1 Cumulative Impacts: Worker Safety MON 87769 soy

bean is not expected to increase the total acreage of soy bean producti on or the use of GE so ybean. Monsanto anticipates that MON 87769 soy bean will be a minor crop, produced to fill a small market need. To a limited extent, if stacked with an herbicide tolerant trait, MON 87769 soy

bean would simply

replace a small percenta ge of acres of the herbicide tolerant soy

bean cultivars already

on the market today . As APHIS anal yz ed in the Proposed Alternative, no hazards of exposure to the new fatty acids exist and therefore cumulative impacts are unlikel y. Monsanto is expected t o stack MON 87769 so ybean with the gl yphosate tolerance trait ( Monsanto, 2010c ) . The introduced protein for th e tolerance is the CP4 EPSPS protein derived from Agrobacterium sp. The U.S. EPA has reviewed the safety of the CP4 EPSPS protein and has established a tolerance exemption for the protein and the genetic material necessary for its production in or on all raw agricultural commodities ( (US - EPA, 1996 ) ; 40 CFR §174.523). This exemption was also based on a safety assessment for allergenicity that included rapid di gestion 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 19 96 suggests the safety of its use. Worker safety issues related to the use of gl yphosate and other U.S. EPA registered pesticides during conventional and GE soy bean production should remain the same. If a grower replaces a non - herbicide - tolerant soy bean variety

with MON 87769 soy

bean it would be expected that there would be a corresponding increase in the post - emergent use of gl yphosate. To the extent that such changes result in the replacement of more toxic herbicides with gl yphosate, the change should p ositively

benefit worker safety. The CP4 EPSPS protein likely to be expressed in MON 87769 soy bean is the same protein previously

reviewed by

the U.S. EPA. Accordingly , worker safety risk associated with cultivation of and exposure to MON 87769 so ybean i s the same as the No Action Alternative. 5.16.2 Cumulative Impacts: Public Health APHI S determined no significant adverse impacts on human health from consumption of the oil derived from MON 87769 soy bean, although certain potential beneficial impacts may be poss ible. However, because Monsanto has decided to stack tolerance to the herbicide gl yphosate with MON 87769 soy

bean, APHI S considers briefly the possible impacts of the gene on human health. Similar products are no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act and have been used for general cultivation beginning in the mid - 1990s with the introduction of Roundup Ready® products providing tolerance to gl yphosate 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 charact eristics have been successfully cultivated in multiple crops in the ensuing ye ars with no evidence of human health impacts.107

The CP4 EPSPS protein confers tolerance to gly phosate. This protein is structurall y homologous and similar functionally

to endogeno us plant EPSPS enzy mes and is identical to the CP4 EPSPS in other commercially

available Roundup Ready® crops, including Roundup Ready® soy bean (40 - 3 - 2 and MON 89788), Roundup Ready® canola, Roundup Ready® sugar beet, Roundup Ready® flax, and Roundup Ready® cotton (USDA - APHI S, 2010c ) . The first generation of Roundup Ready® soy

bean (40 - 3 - 2) no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act in 1995 (USDA - APHIS, 2010c ) . The cp4 epsps gene has been assessed extensively in the last 15 years. The safety of CP4 EPSPS protein present in biotechnology derived crops has been evaluated as part of comprehensive reviews of the safety

of gly phosate exposure and ingestion ( Harrison et al., 1996 ) (see also ( Hammond et al., 1996 ; Padgette et al., 1996 ) ). The CP4 EPSPS enzy

me is likely

to be expressed in MON 87769 containing varieties. FDA ha d no further questions on Monsanto ’s conclusion that their gl yphosate - tolerant soy bean with this enzy me , event MON 89788, when present in feeds and foods derived from this variety is not materially

different in safety , composition, or any other relevant parameter from soy beans now grown, m arketed, and consumed ( see BNF 0104, January 19, 2007, http://www.fda.gov/Food/Biotechnology /Submissions/ucm155610.htm) . The EPA has also reviewed the safety of the CP4 EPSPS protein and has established a tolerance exemption for the protein and the genetic material necessary for its production in or on all raw agricultural commodities ( (US - EPA, 1996 ) ; 40 CFR §174.523). This exemption is based on a safety assessment that included rapid digestion in simulated gastric fluids, lack of homology to known toxins and allergens, and lack of toxicity in an acute oral mouse gavage study . The CP4 EPSPS protein expressed in MON 87769 soybean is the same as that previously reviewed b y the EPA. Accordingl y, 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 soy bean. Moreover, no cumulative effects have been identified b y APHI S. **5.17 Cumulative Impacts: Animal Feed**  No impacts were determined from APHIS’ anal ys is of possib le impacts MON 87769 soy bean on animal feed. However, Monsanto plans to market the MON 87769 soy bean with the Roundup tolerance trait. The gene for the trait expresses the CP4 EPSPS protein, derived from Agrobacterium sp., to achieve gly phosate herbicide tolerance. The U.S. EPA has reviewed the safety of the CP4 EPSPS protein and has established a tolerance exemption for the protein and the genetic material necessary for its production in or on all raw agricultural commodities ( (US EPA, 1996 ) ; 40 CFR §174.523). This exemption is based on a safety assessment that included rapid digestion in simulated gastric fluids, lack of homology to known toxins and aller gens, and lack of toxicity

in an acute oral mouse gavage study . The lack of any documented reports of adverse effects since the introduction of other Roundup Ready® crops in 1996 suggests the safety of its use.108

There are no significant impacts on animal h ealth related to the No Action Alternative or a determination of nonregulated status of MON 87769 soy bean and no cumulative effects have been identified. **5.18 Cumulative Impacts: Domestic Economic Environment**  MON 87769 soy

bean is intended to be cultivated as a specialty soy bean product and its oil fraction will be produced and used within a closed loop stewardship sy stem ( Monsanto, 2010b ) . The likelihood that MON 87769 soy bean will be stacked with an herbicide tolerance trait could potentially

lead some IP producers to repl ace existing specialty so ybean varieties to plant MON 87769 soy

bean as a new specialty

oilseed product. Agronomic and phenotyp ic anal ys es conducted b y Monsanto did not demonstrate any substantial differences between MON 87769 soy bean and conventional varieties. No new agronomic characteristics providing benefits for cultivation beyond traditional soy bean cultivation regions were determined and none of the modifications expressed b y MON 87769 soy bean are considered likel y to result in new acreage devoted to soy bean cultivation outside of those regions where so yb ean is currently cultivated (Monsanto, 2010). The percentage of the U.S. soy bean acreage dedicated to specialty oil soy beans does have the potential to change, contingent upon market acceptance and consumer demand, and specific applications of the specialty products. In the food supplements market, MON 87769 so ybean has the potential to displace fish oils (containing stearidonic and higher level omega - 3 fatty acids) and also some other non - soy oil crops that may

produce SDA (Addendum 1, ( Monsanto, 2010b ) ) . The latter market derives from the likely small scale production of oils from Echium plantagineum , black currant (Ribes ) and a few other plant sources of the fatty acid ( Cy berlipid Center, 2011 ) . In the foods production industry , the ability to provide SDA containing oils for large scale use in various manufactured foods, and baked products will likel y expand business opportunities. These specificall y will include supplementing existing oils used in functional foods and healthful products. For the past decade, so yb ean oil has consistently been the least expensive domestic vegetable oil (Table 16) (USDA - ERS, 2011b ) and the ability to produce a high value specialty fatty acid in soy bean will keep production costs of the oil low. If MON 87769 so ybean oil achieves market acceptance, the product has the potential to marginally displace other vegetable food oils, including other so yb ean, canola, or sunflower oils in certain specialized products, and then most likely as a supplement, and consequentl y may not completely replace other oils in existing formulations for those products. Given that a determination of nonregulated status of MON 87769 soy

bean is not expected to lead to an expansion of U.S. soy bean acreage or substantial changes in oil products industry , APHIS determines no significant impacts from production of MON 87769 soy

bean and no cumulative impacts.109

**Table 16. U.S. vegetable oil prices (dollars /gallon).**  **Marketing Year**  **Soybean**

**Oil Cottonseed** 

**Oil Sunflower** 

**oil Canola** 

**Oil Peanut** 

**Oil Corn Oil**  2000/01 1.09 1.23 1.22 1.35 2.69 1.04 2001/02 1.27 1.38 1.79 1.81 2.48 1.47 2002/03 1.70 2.91 2.55 2.29 3.60 2.17 2003/04 2.31 2.40 2.57 2.60 4.68 2.19 2004/05 1.77 2.16 3.37 2.37 4.13 2.15 2005/06 1.80 2.27 3.13 2.39 3.42 1.94 2006/07 2.39 1.98 4.47 3.12 4.08 2.45 2007/08 4.01 5.66 7.02 5.05 7.28 5.34 2008/09 2.48 2.09 3.87 3.04 6.04 2.52 2009/10 2.77 3.01 4.07 3.30 4.59 3.03 2010/11 4.27 4.46 5.92 4.77 6.31 4.65 Source: Table 9 (converted to dollars per gallon based on a vegetable oil conversion factor of 7.7 pounds per gallon) ( USDA - ERS, 2011b ) . **5.19 Cumulative Impacts: Trade Economic Environment**  Contingent upon producer and consumer acceptance, availability , and price, and considering that the market for MON 87769 soy bean will be about 100,000 acres b y 2016, this variety will occup y 0.5% of acreage planted to soybean in the a ffected area. Thus, there is insignificant potential to displace some of these comparable, non - soy bean vegetable oils on the international market. Consistent with the anal ys is of international markets for GE soy bean, a specialty

oil for a small healthful products niche, and GE crops generall y, APHIS has determined that there are no past, present, or reasonable foreseeable effects of the proposed action which would present a negative cumulative impact on the trade economic environment. **5.20 Cumulative Impacts: Social Environment**  Th e planting and production of oils deriving from MON 87769 will not change the percentage of growers who plant specialty soy bean products because the market for these products will likely remain small for the next five years (Monsanto, 201l). No changes can be foreseen in the crusher/refiner businesses, since again, onl y those businesses which already crush small scale specialty soy bean will likely

be signed up to accept the MON 87769 soy bean. APHI S has determined that there are no past, present, or reason ably foreseeable actions that will aggregate110

with the effects of the proposed action to impact the social environment surrounding so yb ean farming.111

**6 THREATENED AND ENDAN**  **GERED SPECIES** The Endangered Species Act (ESA) of 1973, as amended, is one of the most far - reaching wildlife conservation laws ever enacted b y any nation. Congress, on behalf of the American people, passed the ESA to prevent extinctions facing many species of fish, wildlife and plants. The purpose of the ESA is to conserve endangered and threatened species and the ecos ys tems on which they

depend as key

components of America’s heritage. To implement the ESA, the U.S. Fish & Wildlife Service (USFWS) works in cooperation with the National Marine Fisheries Service (NMFS), other Federal, State, and local agencies, Tribes, non - governmental organizations, and private citizens. Before a plant or animal species can receive the protection provided b y the ESA, it must first be added to the Federal list of threatened and endangered wildlife and plants . A species is added to the list when it is determined by the USFWS/NMFS to be endangered or threatened because of any of the following factors:  The present or threatened destruction, modification, or curtailment of its habitat or range;  Overutilization fo r commercial, recreational, scientific, or educational purposes;  Disease or predation;  The inadequacy

of existing regulatory

mechanisms; and  The natural or manmade factors affecting its survival. Once an animal or plant is added to the list, in accordance with the ESA, protective measures apply to the species and its habitat. These measures include protection from adverse effects of Federal activities. Section 7 (a)(2) of the ESA requires that Federal agencies, in consultation with USFWS and/or the NMFS, ensure that any action they

authorize, fund, or carry

out is not likely

to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. It is the responsibility of the Federal agency

taking the action to assess the effects of their action and to consult with the USFWS and NMFS if it is determined that the action “may

affect” listed species or critical habitat. To facilitate APHI S’ ESA consultation process, APHI S met with the U SFWS from 1999 to 2003 to discuss factors relevant to APHI S’ regulatory

authority and effects analy sis for petitions for nonregulated status, and developed a process for conducting an effects determination consistent with the Plant Protection Act of 2000 ( Title IV of Public L aw 106 - 224) . This process is described in a decision tree document, which is presented as appendix B. APHI S uses this process to help fulfill its obligations and responsibilities under Section 7 of the ESA for biotechnology regulatory actions. APHI S’ regulatory

authority for GE organisms under the PPA is limited to those for which it has reason to believe might be a plant pest or those for which APHI S does not have sufficient information to determine that the GE organism is unlikely to pose a plant pest risk (7 CFR § 340.1). After completing a plant pest risk anal ys is, APHI S concluded that MON 87769 soy bean does not pose a plant pest risk (USDA - APHIS, 2010c ) . Because the agency has concluded that MON 87769 soy

bean is unlikely

to pose a plant pest risk, a determination of nonregulated status of MON 87769 so ybean is a response that is consistent with the plant pest provisions of the PPA, the regulations codified in 7 CFR part 340, and the biotechnology regulatory

pol icies in the112

Coordinated Framework. Nevertheless, APHI S has chosen to analyze the potential effects to threatened and endangered species and critical habitat under the ESA. As part the environmental review process, APHIS thoroughl y reviews genetically en gineered product information and data to inform the ESA effects analy sis and, if necessary , the biological assessment related to the organism (generall y a plant species, but may also be other geneticall y engineered organisms) for which regulatory

jurisdict ion applies under the plant pest provisions of the Plant Protection Act of 2000 and implementing regulations in 7 CFR p art 340 . For each transgene(s)/transgenic plant the following information, data, and questions are considered b y APH IS :  A review of the biology and taxonomy

of the crop plant and its sexually compatible relatives;  Characterization of each transgene with respect to its structure and function and the nature of the organism from which it was obtained;  A determination of where the new transgene and its products (if any) are produced in the plant and their quantity ;  A review of the agronomic performance of the plant including disease and pest susceptibilities, weediness potential, and agronomic and environmental impact;  Determination of the con centrations of known plant toxicants (if any are known in the plant); and  Analy sis to determine if the transgenic plant is sexually compatible with any

threatened or endangered plant species (TES) or a host of any TES. In following this process, APHI S evaluated the potential effects that a determination of nonregulated status to MON 87769 soy bean would have on Federally listed TES and species proposed for listing, as well as designated critical habitat and habitat proposed for designation (See Appendix B) . Based upon the scope of the EA and production areas identified in the Affected Environment section of the EA, APHIS obtained a list of TES species (listed and proposed) from the USFWS Environmental Conservation Online Sy stem (ECOS) for each state where MO N 87769 so yb ean is likely to be commerciall y produced ( ECOS; as accessed 4/15/2011 at http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrence.jsp ) . As discussed above in the anal ys is of Gene Movement and Weediness and Plants, APHI S has determined that there is no risk to unrelated plant species from the cultivation of MON 87769 soy bean . Monsanto submitted results of a comparison of agronomic and phenoty pic differences between MON 87769 soy bean and conventional soy bean; there i s no reason to believe that MON 87769 soy

bean is different from the commercial variety from which it was developed (USDA APHI S, 2010c ) . Consistent with these studies, APHI S has concluded the determination of nonregulated status of MON 87769 soy bean does not present a plant pest risk, does not present a ri sk of weediness, and does not present an increased risk of gene flow when compared to other currentl y cultivated varieties. Accordingl y, APHIS focuses our assessment of possible impacts on TES animal species, particularl y those potentially at risk from the consumption of MON 87769 soy bean . Few TES animal species are likel y to frequent so ybean fields because the habitat would not be suitable. Some animal species, particularly migratory

birds, may

visit soy bean fields, but their presence would be a passin g one as the habitat is either not suitable or does not contain constituent elements required b y the species. It is reasonable to assume that populations of the species113

adjacent to so ybean production fields could be impacted b y aspects of cultivation of M ON 87769 soy bean or could feed on MON 87769 soy bean . As described below, the EPA and the FDA have conducted independent evaluations of these potential risks directly relevant to APHI S’ anal ys is. Monsanto measured compositional aspects of MON 87769 soy bean and compared these data with conventional soy

bean. The intended expression of SDA and also of gamma linolenic acid is new to commodity

soy bean. Although the animal feed consultation with FDA is pending, submitted data showed that these new components are both intermediates in mammalian sy stems during production of docosahexaenoic acid ( DHA ) and eicosapentaenoic acid ( EPA ) , and also are found in the environment in numerous other plant and animal sources. L inoleic acid (18:2) is decreased to about 41% of control percentage, and this altered soy bean content is similar to that of canola oil. Statistically significant but small differences were observed in the comparisons of the A3525 conventional variety to MON 87769 soy bean 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). APHI S evaluated these differences in composition, and has determined that those reported for MON 87769 either fall within the ty pical commerci al range for percentage composition, or within the 99% tolerance interval for soy bean composition ( Monsanto, 2010b ) . For s everal amino acid s % of total amino acid content , % dry weight of proximates (protein and carboh ydrate) and two isoflavones were also different from controls ( US - EPA, 1993b ) , but these also were within either the range of commercial values or the 99% tolerance level for commercial so ybean ( Monsanto, 2010b ) . Because the composition of MON 87769 so ybean is either similar to other commercial so ybean plants in most constituents, or expresses fatty acids that are unlikel y to impact human or animal health with c onsumption, it is unlikely that MON 87769 soy

bean poses a hazard to TES animal species. Because no hazards are identified, the risk of MON 87769 so ybean affecting TES animal species is also unlikely , regardless of exposure. Based on the above information, APHI S has determined that the Preferred Alternative, a determination of nonregulated status of MON 87769 soy bean , would have no effect on Federally listed TES proposed for listing, or on designated critical habitat or habitat proposed for designation. Fo llowing the BRS Decision Tree Document that indicates when a consultation with FWS is triggered (See Appendix B), APHI S BRS has determined that a written concurrence or formal consultation with the USFWS is not required for this action. **6.1 Cumulative Impacts**  **of Stacking MON 87769 Soybean with a Glyphosate Tolerant Trait on TES**  Monsanto has stated that MON 87769 soy bean will likely be conventionally bred with the cp4 epsps gene (gl yphosate tolerance trait), and as a result, APHI S has decided to conduct a cumulative NEPA impact analy sis of this potential future action on TES. The U.S. EPA has published an exemption from tolerance for the cp4 epsps gene and the material necessary

for its production in all plants (US - EPA, 1996). Roundup Ready® crops incorporating the cp4 epsps gene have been marketed since the mid - 1990s with no reports of any non - target impacts associated with exposure to or consumption of the modified crop. Accordingl y, no impacts to TES are anticipated as a result of exposure to the cp4 epsps gene.114

T he U.S. EPA has conducted a review of the potential impacts of gl yphosate to non - target species, and has determined that when used in accordance with the FIFRA label, the potential impacts to non - target species is not significant ( US - EPA, 1993a , 1993b ) . As the action agency for pesticide registrations, U.S. EPA has the responsibility to conduct an assessment of effects of a registration action on TES. The U.S. EPA Endangered Species Protection Program web site, http://www.epa.gov/espp/, describes the U.S. EPA assessment process for endangered species. Some of the elements of that process, generall y taken from the web site, are summarized below. When registering a pesticide or reassessing the potential ecological risks from use of a currentl y registered pesticide, U.S. EPA evaluates extensive exposure and ecological effects data to determine how a pesticide will move through and break down in the environment. Risks to birds, fish, invertebrates, mammals and plants are routinely assessed and used in U.S. EPA’s determinations of whether a pesticide may be licensed for use in the U.S. U.S. EPA’s core pesticide risk assess ment and regulatory processes ensure that protections are in place for all populations of nontarget species, including TES. These assessments provide U.S. EPA with information needed to develop label use restrictions for the pesticide. These label restri ctions carry

the weight of law and are enforced by U.S. EPA and the states (Federal Insecticide, Fungicide, and Rodenticide Act 7 USC §136j (a)(2)(G) Unlawful acts). Because TES may need specific protection, U.S. EPA has developed risk assessment procedur es, described in the Overview of the Ecological Risk Assessment Process ( U S - EPA, 2004 ) , to determine whether individuals of a listed species have the potential to be harmed by a pesticide; and if so, what specific protections may be appropriate. U.S. EPA’s conclusion regarding the potential risks a pesticide may pose to a li sted species and any designated critical habitat for the species, after conducting a thorough ecological risk assessment, results in an "effects determination" in accordance with Section 7 (a)(2) of the ESA. As a part of U.S. EPA’s TES effects assessment f or the California red - legged frog ( US - E PA, 2008 ) , U.S. EPA evaluated the effect of gl yphosate use at rates up to 7.95 pounds active ingredient per acre ( lb a.i./A ) on fish, amphibians, aquatic invertebrates, aquatic plants, birds, mammals, and terrestrial invertebrates. The U.S. EPA assessm ent 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 pro cess and label use restrictions for gl yphosate tolerant crops imposed under authority of FIFRA. U.S. EPA has imposed specific label use restrictions for gl yphosate use when applied with aerial equipment including “The product should only be applied when the potential for drift to adjacent sensitive areas (e.g., residential areas, bodies of water, known habitat for threatened or endangered species, non - target crops) is minimal (e.g., when wind is blowing away from the sensitive areas).” This requirement sho uld protect TES that may be at risk from exposure to gl yphosate. To facilitate pesticide applicator adherence to U.S. EPA label use restrictions for gly phosate, Monsanto has designed a web - based program (www.Pre - Serve.org), designed to ensure no effect of gl yphosate applications on threatened and endangered plant species. Pre - Serve instructs growers to observe specific precautions including buffer zones when spraying gl yphosate herbicides on gl yphosate - tolerant crops near threatened and endangered plant sp ecies that may be115

at risk. In addition, label requirements for Monsanto’s Roundup® formulations and gl yphosate formulations marketed by other manufacturers prohibit application in conditions or locations where adverse impact on federally designated endang ered/threatened plants or aquatic species is likely . In conclusion, there are legal precautions in place (U.S. EPA label use restrictions) and “best practice” guidance to reduce the possibility of exposure and adverse impacts to TES from gl yphosate application. U.S. EPA has considered potential impacts to TES as part of their registration and labeling process for gl yphosate; and adherence to U.S. EPA label use restrictions by the pesticide applicator will ensure that the use of gl yphosate will not adversel y affect TES or critical habitat. Furthermore, pesticide applicators are legally require d to follow U.S. EPA l abel use restrictions . Finally , cultivation of MON 87769 soy bean is not expected to result in an increase in the application of gly

phosate or changes of any other herbicide treatments when compared with existing herbicide - tolerant and non - GE so ybean varieties. APHIS has determined that there are no past, present, or reasonably foreseeable actions that would aggregate with effects of the proposed action on TES.116

**7 CONSIDERATION OF EXE**  **CUTIVE ORDERS, STAND ARDS, AN D TREATIES**  **RELATING TO ENVIRONM ENTAL IMPAC**  **TS 7.1**  **Executive Orders with Domestic Implications** The following executive orders require consideration of the potential impacts of the Federal action to various segments of the population.  **Executive Order**  **(EO )**  **12898 (** 

**US -**  **NARA, 2010a** 

**) ,**  **"Federal Actions**  **to Address**  **Environmental Justice**  **in Minority**  **Populations and**  **Low -**  **Income Populations,"**  requires F ederal agencies to c onduct their programs, policies, and activities that substantially

a ffect human health or the environment in a manner so as not to exclude persons and populations from participation in or benefiting from such programs . Italso enforces existing statutes t o prevent minority and low - income communities from being subjected to disproportionately high and adverse human health or environmental effects.  **EO 13045,**  **“Protection of**  **Children from**  **Environmental Health**  **Risks and**  **Safety Risks,”**  acknowledges that children may s uffer disproportionately f rom environmental health and safety risks because of their developmental stage, greater metabolic activity levels, and behavior patterns, as compared to adults . The EO (to the extent permitted by law and consistent with the agency ’s mission) requires each F ederal agency t o identify , assess, and address environmental health risks and safety risks that may disproportionately

affect children. Each alternative was analyzed with respect to EO 12898 and EO 13045 . Neither alternative is expected to have a disproportionate adverse effect on minorities, low - i ncome populations, or children. Based on the information submitted by the applicant and assessed by APHIS, MON 87769 soy bean is agronomicall y, phenotypically, and biochemicall y comparable to conventional soy bean except for the intended unique fatty acid profile (i.e., the presence of SDA and GLA). The information provided in the petition indicates that the two desaturase protein s, PjD6D and NcFad3, expressed in MON 87769 soy bean 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 soy bean oil is GRAS under the intended con ditions of use” ( US - FDA, 2009a ) . The use of SDA so yb ean oil in selected food categories could p rovide a wide range of dietary

alternatives for increasing human intake of omega - 3 fatty acid. The oil derived from MON 87769 soy bean , is intended for use only in certain markets and will be identity preserved to maintain its value and assure its use in ap propriate food applications. Additionally , the defatted soy bean meal from MON 87769 soy bean is compositionally

similar to other defatted commodity so ybean meal and will be used in a manner similar to the meal derived from these commodity

soy bean. This inf

ormation establishes the safety of MON 87769 soy bean and its products to humans, including minorities and low income populations who might be exposed to them through agricultural production and/or processing. No additional safety precautions would need to be taken.117

None of the impacts on agricultural practices expected to be associated with a determination of nonregulated status of MON 87769 soy bean are expected to have a disproportionate adverse effect on minorities and low income populations. MON 8776 9 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 Soy bean , soy bean hy brid varieties may

be produced with MON 87769 soy bean and other nonregulated soy bean hy brids containing herbicide tolerant traits. Thus, pesticide application practices and usage associated with a determination of nonregulated status of MON 87 769 soy bean are not expected to change from the current trends for existing nonregulated GE soy bean. The following executive order addresses Federal responsibilities regarding the introduction and effects of invasive species: **EO 1311 (** 

**US -**  **NARA, 2010b**

**) , “Invasive Species,”**  states that Federal agencies take action to prevent the introduction of invasive species, to provide for their control, and to mini mize the economic, ecological, and human health impacts that invasive species cause. Non - GE soy

bean , as well as other modified fatty acid soy bean varieties , are widely grown in the U.S. Based on the historical experience with these varieties and the dat a submitted by the applicant and reviewed by APHIS, MON 87769 soy bean are sufficiently

similar in fitness characteristics to other soybean varieties currentl y grown and are not expected to become weedy or invasive (USDA - APHIS, 2010c ) . The following executive order requires the protection of migratory bird populations: **EO 13186 (** 

**US -**  **NARA, 2010b**

**) , “Responsibilities of Federal Agencies to Protect**  **Migratory Birds,”** states that federal agencies taking actio ns that have, or are likely to have, a measurable negative effect on migratory bird populations are directed to develop and implement, within two years, a Memorandum of Understanding (MOU) with the Fish and Wildlife Service that shall promote the conservation of migratory bird populations. Monsanto has presented results of field trials conducted to evaluate field phenotypic, agronomic and environmental interactions. These data, presented in Appendix G of the petition (USDA - APHIS, 2010c ) , showed no differences in arthropod damage or arthropod pest and be neficial insect abundance between MON 87769 soybean and other varieties, supporting the conclusion that the modified oil trait is unlikely to impact food sources for migratory bird species. Migratory bird use of soybean in harvested fields is reduced in t erms 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. M igratory 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 soy bean compared to commercial soybean or non - GE - soybean, apart118

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. B ased 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, 2 010b** 

**) , “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. APHI S has given this EO careful consideration and does not expect a significant environmental impact outside the U.S. in the event of a determination of nonregulated status of MON 877 69 . All existing national and international regulatory authorities and p hy

tosanitary regimes that currentl y appl y to introductions of new soy bean cultivars internationally apply equally to those covered b y an APHIS determination of nonregulated status under 7 CFR part 340. Any international trade of MON 877 69 subsequent to a determination of nonregulated status of the product would be fully subject to national phyt osanitary requirements and be in accordance with phy tosanitary standards developed under the International Plant Protection Convention ( IP PC, 2010 ) . The purpose of the IPPC “is to secure a common and effective action to prevent the spread and introduction of pests of plants and plant products and to promote appropriate measures for their control” ( IP PC, 2010 ) . The protection it affords extends to natural flora and plant products and includes both direct and indirect damage by pests, including weeds. The IPPC establishes a standard for the reciprocal acceptance of ph yt osanitary certification among the nations that have signed or acceded to the Convention (172 countries as of March 2010). In April 2004, a standard for PRA of living modified organisms (LMOs) was adopted at a meeting of the governing body of the IPPC as a supplement to an existing standard, International Standard for Phy tosanitary Measure No. 11 (I SPM - 11, Pest Risk Analy sis for Quarantine Pests). The standard acknowledges that all LMOs will not present a pest risk and that a determination needs to be made earl y in the PRA for importation as to whether the LMO poses a potential pest risk resulting from the genetic modification. APHI S pest risk assessment procedures for genetically engineered organisms are consistent with the guidance developed unde r the IPPC. In addition, issues that may relate to commercialization and transboundary movement of particular agricultural commodities produced through biotechnology are being addressed in other international forums and through national regulations. The C artagena Protocol on Biosafety is a treaty under the United Nations Convention on Biological Diversity (C BD) that established a framework for the safe transboundary movement, with respect to the environment and biodiversity , of LMOs, which include those mo dified 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 thu s 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 trans boundary movement of LMOs intended for environmental release (field trials or commercial planting) will require119

consent from the importing country under an advanced informed agreement (AIA) provision, which includes a requirement for a risk assessment cons istent 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 d ecisions to the Biosafety Clearinghouse database on domestic use of LMOs for FFP that may be subject to transboundary

movement. To facilitate compliance with obligations to this protocol, the U.S. Government has developed a website that provides the statu s of all regulatory reviews completed for different uses of bioengineered products (NBII, 2 010 ) . These data will be available to the Biosafety Clearinghouse. APHI S continues to work toward harmonization of biosafety and biotechnology consensus documents, guidelines, and regulations, including within the North American Plant Protection Organization (NAPPO), which includes Mexico, Canada, and the U.S., and within the Organization for Economic Cooperation and Development (OECD). NAPPO has completed three modules of the Regional Standards for Phyt osanitary Measures (RSPM) No. 14, Importation a nd Release into the Environment of Transgenic Plants in NAPPO Member Countries (NAPPO, 2009 ) . APHI S also participates in the North American Biotechnology Initiative (NABI) , a forum for information exchange and cooperation on agricultural biotechnology issues for the U.S., Mexico, and Canada. In addition, bilateral discussions on biotechnology regulatory issues are held regularl y with other countries including Argentina, Brazil, Japan, China, and Korea. **7.2 Compliance with Clean W**  **ater Act and Clean Air Act** This EA evaluated the changes in soybean production due to a determination of nonregulated status of MON 87769 soy bean . Cultivation of MON 87769 soy bean will not lead to the increased production of soybean in U.S. agriculture. There is no expected change in water use due to the cultivation of MON 87769 soy bean 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 soy

bean . Based on this review, APHI S concludes that the cultivation of MON 87769 soy bean would inherently

comply with the Clean Water Act and the Clean Air Act. **7.3 Impacts on Unique Characteristics of Geographic Areas**  A determination of non - regulat ed status of MON 87769 soy bean is not expected to adversel y impact unique characteristics of geographic areas such as park lands, prime farm lands, wetlands, wild and scenic areas, or ecologicall y critical areas. The common agricultural practices that wo uld be carried out in the cultivation of MON 87769 soy bean are not expected to deviate from current practices. The product will be deployed on120

agricultural land currently suitable for production of soy bean, will replace existing varieties, and is not expe cted to increase the acreage of so ybean production. There are no proposed major ground disturbances; no new phys ical destruction or damage to property; no alterations of property, wildlife habitat, or landscapes; and no prescribed sale, lease, or transfer of ownership of any property. This action is limite d to a determination of non regulated status of MON 87769 soy bean . This action would not convert land use to nonagricultural use and therefore would have no adverse impact on prime farm land. Standard agricultural practices for land preparation, planting , irrigation, and harvesting of plants would be used on agricultural lands planted to MON 87769 soy bean including the use of EPA registered pesticides. Applicant’s adherence to EPA label use restrictions for all pesticides will mitigate potential impacts to the human environment. **7.4 National Historic Preservation Act (NHPA) of 1966 as Amended**  The NHPA of 1966 and its implementing regulations (36 CFR 800) require Federal agencies to: 1) determine whether activities they propose constitute "undertakings" that have the potential to cause effects on historic properties and 2) if so, to evaluate the effects of such undertakings on such historic resources and consult with the Advisory Council on Historic Preservation (i.e., State Historic Preservation Office, Tribal Historic Preservation Officers), as appropriate. A determination of nonregulated status of MON 87769 soy bean is not expected to adversel y impact cultural resources on tribal properties. Any farming activity that may be taken b y farmers on tribal lands would only be conducted at the tribe’s request; thus, the tribes would have control over any potential conflict with cultural resources on tribal properties. A determination of nonregulated status of MON 87769 soy bean would have no impact on districts, sites, highway s, structures, or objects listed in or eligible for listing in the National Register of Historic Places, nor would it likely cause any

loss or destruction of significant scientific, cultural, or historical resources. This action is limited to a determination of non regulated status of MON 87769 . A determination of nonregulated status of MON 87769 soy bean is not an undertaking that may directly or indirectl y cause alteration in the character or use o f historic properties protected under the NHPA. In general, common agricultural activities conducted under this action do not have the potential to introduce visual, atmospheric, or noise elements to areas in which they are used that could result in effec ts on the character or use of historic properties. For example, there is potential for increased noise on the use and enjo yment of a historic property during the operation of tractors and other mechanical equipment close to such sites. A built - in mitigating factor for this issue is that virtually

all of the methods involved would only have temporary

effects on the audible nature of a site and can be ended at any time to restore the audible qualities of such sites to their original condition with no further adverse effects. Additionally , these cultivation practices are already being conducted throughout the soy bean production regions. The cultivation of MON 87769 soy bean does not inherently

change any

of these agronomic practices so as to give rise to an impact under the NHPA.121

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Warner RE, Havera S P, and David LM. (1985) Effects of Autumn Tillage Sy stems on Corn and Soy bean Harvest Residues in I llinois. The Journal of W ildlife Management, 49 (1), 185 - 190. Wijendran V and Hayes KC. (2004) Dietary n - 6 and n - 3 Fatty Acid Balance and Cardiovascular Health. Annual Review of Nutrition, 24 (1), 597 - 615. Wilcox JR and Cavins JF. (1992) Normal and Low L inolenic Acid Soy bean Strains: Response to Planting Date. Crop Sci., 32 (5), 1248 - 1251. Wilkes RS. (2008) L ow linolenic soy beans and beyond. Lipid Technology, 20 ( 12), 277 - 279. Wilson EO. (1988) Biodiversity . Washington, DC: National Academ y Press. Wolfenbarger L, Naranjo SE, Lundgren JG, Bitzer RJ, and Watrud L S. (2008) Bt Crop Effects on Functional Guilds of Non - Target Arthropods: A Meta - Analy sis. PLoS ONE 3 (5), 1 - 11. Wood D, Setubal J, Kaul R, Monks D, Kitajima J, Okura V, Zhou Y, Chen L, Wood G, Almeida N, Woo L , Chen Y, Paulsen I, Eisen J, Karp P, Bovee S, Chapman P, Clendenning J, Deatherage G, Gillet W, Grant C, Kutyavin T, Levy R, Li M, McClelland E, Palmieri A, Ray mond C, Rouse G, Saenphimmachak C, Wu Z, Romero P, Gordon D, Zhang S, Yoo H, Tao Y, Biddle P, Jung M, Krespan W, Perry M, Gordon - Kamm B, Liao L, Kim S, Hendrick C, Zhao Z, Dolan M, Chumley F, Tingey

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**9 APPENDIX A: FDA SUSB**  **STANCES GENERALLY RE COGNIZED AS SAFE**  **(GRAS) –**  **AGENCY RESPONSE LETT ER GRAS NOTICE NO. G** **RN 000283** 

### Agency Response Letter GRAS Notice No. GRN 000283 **CFSAN/Office of Food Additive Safety** September 4, 2009 Raymond C. Dobert, Ph.D. Monsanto Company 800 North Lindbergh Blvd St. Louis, MO 63167 Re: GRAS Notice No. GRN 000283 Dear Dr. Dobert: The Food and Drug Administration (FDA) is responding to the notice, dated February 25, 2009, that you submitted in accordance with the agency’s proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal). FDA received the notice on February 26, 2009, filed it on March 3, 2009, and designat ed 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 c ommon 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 ingr edient 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 S afety and Applied Nutrition. As part of its notice, Monsanto includes the report of a panel of individuals (Monsanto’s GRAS panel) who evaluated the data and information that are the basis for Monsanto’s GRAS147

determination. Monsanto considers the members o f 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 obtai ned 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 c onventional 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 co nventional 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 bio engineered 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 t he 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 - hex ane/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 oi l. 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 soybe an 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 s pecifications 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 fatty acids (< 0.1 per cent), 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 t he intended use levels in conjunction with food consumption data included in the148

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, su nflower 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 serv ing 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 me tabolized 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 st udies 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 i n humans where SDA soybean oil, consumed at 3.66 g/d for 16 weeks, did not affect physiological or blood chemistry endpoints. Other published studies in which humans consumed SDA oil derived from non - soybean sources, showed no adverse effects at levels up to 1.875 g/day. **Standards of Identity** In the notice, Monsanto states its intention to use SDA soybean oil in several food categories, including foods for which standards of identity exist, located in Title 21 of the Code of Federal Regulations. We note tha t an ingredient that is lawfully added to food products may be used in a standardized food only if it is permitted by the applicable standard of identity. **Potential Labeling Issues**149

Under section 403(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA), a food is misbranded if its labeling is false or misleading in any particular. Section 403(r) of the FFDCA lays out the statutory framework for the use of labeling claims that characterize the level of a nutrient in a food or that characterize the relations hip 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, Monsa nto 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 eigh t foods or food groups (i.e., milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans) or a food ingredient that contains protein derived from one of those foods. Issues associated with labeling food are the responsibility of ONLDS. **Use in Meat, Poultry, and Egg Products** During its evaluation of GRN 000283, FDA consulted with the Risk and Innovations Management Division of the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture. Under the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act, FSIS is responsible for determining the efficacy and suitability of food ingredients in meat, poultry, and egg products as well as prescribing safe conditions of use. Suitability relates to the effectiveness of the ingredient in performing the intended purpose of use and the assurance that the conditions of use will not result in an adulterated product, or one that misleads consumers. FSIS requested that FDA advis e 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 Develop ment, 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 pro hibits the introduction or delivery for introduction into interstate150

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 biologi cal 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 certa in 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 delive red 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 int ended 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 marke ts 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 notic e 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 th e hyperlinks from the “Food” topic to the “Food Ingredients and Packaging” section to the “Generally Recognized as Safe (GRAS)” page where the GRAS Inventory is listed. Sincerely, Mitchell A. Cheeseman, Ph.D. Acting Director Office of Food Additive Safety Center for Food Safety and Applied Nutrition cc: John M. Hicks, Jr. DVM, MPH Risk and Innovations Management Division Office of Policy and Program Development Food Safety and Inspection Service United States Department of Agriculture George Washington Car ver Center (GWCC) 5601 Sunnyside Ave., Mailstop 5271 Beltsville, MD 20705 - 5271151 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.152

**10 APPENDIX B: APHI**  **S THREATENED AND END ANGERED SPECIES DECI**  **SION TREE FOR FWS CONSULT**  **ATIONS** 

### DECISION TREE ON WHETHER SECTION 7 **CONSULTATIONS WITH**  **FWS IS TRIGGERED FOR PETITIONS OF TRANSGENIC PLANTS** This decision tree document is based on the phenoty pes (traits) that have bee n field tested under APHI S oversight (for a list of approved field tests, visit In formation S ys tems for Biotechnology .) APHI S will re - evaluate and update this decision document as it receives new applications for field testing of new traits that are geneticall y engineered into plants. **BACKGROUND** For each transgene(s)/transgenic plant the following information, data, and questions will be addressed b y APHI S, and the EAs on each petition will be publicly available. APHI S review will encompass:  A review of the biology , taxonomy , and weediness potential of the crop plant and its sexually compatible relatives;  Characterization of each transgene with respect to its structure and function and the nature of the organism from which it was obtained;  A determination of where the new transgene and its products (if any) are produced in the plant and their quantity ;  A review of the agronomic performance of the plant including disease and pest susceptibilities, weediness pot ential, and agronomic and environmental impact;  Determination of the concentrations of known plant toxicants (if any are known in the plant),  Analy sis to determine if the transgenic plant is sexually compatible with any

threatened or endangered plant s pecies (TES) or a host of any TES. FDA published a policy

in 1992 on foods derived from new plant varieties, including those derived from transgenic plants (http://vm.cfsan.fda.gov/~lrd/fr92529b.html and http://vm.cfsan.fda.gov/~lrd/consulpr.html). The F DA’s policy requires that geneticall y engineered foods meet the same rigorous safety standards as is required of all other foods. Many of the food crops currently being developed using biotechnology do not contain substances that are significantl y different from those already consumed by human and thus do not require pre - market approval. Consistent with its 1992 policy , FDA expects developers to consult with the agency

on safety and regulatory

questions. A list of consultations is available at http://vm.c fsan.fda.gov/~lrd/biocon.htmlhttp://vm.cfsan.fda.gov/~lrd/biocon.html. APHI S considers the status and conclusion of the FDA consultations in its EAs.153

Below is a description of our review process to whether a consultation with U.S. Fish and Wildlife Servic e is necessary . If the answer to any of the questions 1 - 4 below is yes, APHI S will contact FWS to determine if a consultation is required: 1) Is the transgenic plant sexually compatible with a TE plant2 without human intervention? 2) Are naturally

occurring plant toxins (toxicants) or allelochemicals increased over the normal concentration range in parental plant species? 3) Does the transgene product or its metabolites have any significant similarities to known toxins 3 )? 4) Will the new phenoty pe(s) imparted to the transgenic plant allow the plant to be grown or employed in new habitats (e.g., outside agro - ecosy stem) 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 S ervice is **NOT** necessary . A. The transgene acts only in one or more of the following way s: As a structural barrier to either the attachment of the pest to the host, to penetration of the host by the pest, to the spread of the pest in the host plant (e.g., the production of lignin, callose, thickened cuticles); In the plant by

inactivating or resisting toxins or other disease causing substances produced b y the pest; By creating a deficiency

in the host of a component required for growth of the pest (such as with fungi and bacteria);

2 APHIS will provide FWS a draft EA that will address the impacts, if any, of gene movement to the T ES plant. 3 Via a comparison of the amino acid sequence of the transgene’s protein with those found in the protein databases like PIR, Swiss - Prot and HIV amino acid data bases. 4 Such phenotypes might include tolerance to environmental stresses such as drought, salt, frost, aluminum or heavy metals. 5 Pest resistance would include any toxin or allelochemical that prevents, destroys, repels or mitigates a pest or effects any vertebrate or invertebrate animal, plant, or microorganism.154

By initiating, enhancing, or potentiating the endogenous host hy persensitive disease resistance response found in the plant; In an indirect manner that does not result in killing or interfering with normal growth, development, or behavior of the pest; B. A pest derived transgene is expressed in the plant to confer resistance to that pest (such as with coat protein, replicase, and pathogen virulence genes). **For the biotechnologist: Depending on the outcome of the decision tree, initial the appropriate decision below and**  **incorporate its language into the EA. Retain**  **a hard copy of this decision document in the petition’s file.** 

________ BRS has reviewed the data in accordance with a process mutually agreed upon with the U.S. Fish and Wildlife Service to determine when a consultation, as required under Section 7 of the Endangered Species Act, is needed. APHIS has reached a determination that the release following a determination of non regulated status would have no effects on listed threatened or endangered species and consequently , a written concurrence or formal con sultation with the Fish and Wildlife Service is not required for this EA.

________ BRS has reviewed the data in accordance with a process mutually agreed upon with the U.S. Fish and Wildlife Service to determine when a consultation, as required under Secti on 7 of the Endangered Species Act, is needed. APHIS reached a determination that the release following a determination of non regulated status is not likely to adversel y affect any

listed threatened or endangered species and consequently obtained written concurrence from the Fish and Wildlife Service.

________ BRS has reviewed the data in accordance with a process mutually agreed upon with the U.S. Fish and Wildlife Service to determine when a consultation, as required under Section 7 of the Endangered Sp ecies Act, is needed. APHI S reached a determination that the release following a determination of non - regulated status is likely to affect adversel y one or more listed threatened or endangered species and has initiated a formal consultation with the Fish and Wildlife Service.155

**11 APPENDIX C: PETITION**  **FOR THE DETERMINATIO N OF NONREGULATED**  **STATUS FOR MON 87769 –**  **ADDENDUM: POTENTIAL MARKET IMPACT OF**  **MON 87769**156



## Petition for the Determination of Nonregulated Status for

**MON 87769**  **ADDENDUM Potential Market Impact of MON**  **87769**

Submitted July 1 st 

## , 2011 OECD Unique Identifier: MON - 87769 - 7 Monsanto Petition Num

ber: 09 - 183 - 01p157



### Introduction Monsanto has developed biotechnology- derived soy bean MON 87769 (SDA soy bean) that contains stearidonic acid (SDA), a sustainable alternate source of an omega - 3 fatty acid to help meet the need for increased dietary i ntake of long chain omega - 3 fatty acids. Inm ammals, SDA is a metabolic intermediate in the production of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) from alpha linolenic acid (ALA), a common dietary c onstituent. Refined oil produced from MON 87769 contains approximately 2 0 to 3 0% SDA (wt% of total fatty a cids) and can be included in a range of food products for health benefits. T he oil from MON 87769 (SDA soy

bean oil) is Generally

R ecognized As Safe (GRAS) in the United States and can be used for the production of products such as margarine, shortenings, salad dressings, ready- to - eat foods, and other food categories specified in the GRAS notification 6

. MON 87769 is a specialty trait soy bean, not developed for the commodity s oy bean market, and it is anticipated that MON 87769 w ill be a low acreage product planned initially f or production in North America. In bringing this product to market, Monsanto will adhere to the Biotechnology

Industry O rganization’s (BIO’s) Product Launch Stewardship policy 7 , including its Annex 2: “Spec ialty

Use Traits in Commodity Crops.” 

### Mark**et and Trade Assessment:** Monsanto has evaluated the potential impacts from the introduction of MON 87769 into the marketplace. This assessment which is hereafter referred to as ‘market and trade assessment’ has taken into consideration the potential impacts which could be anticipated within the value chain due to the introduction of SDA soy bean. T he defatted soy bean meal from MON 87769 is compositionally

s imilar to other commodity defatted soy bean meal and will be used in a manner similar to commodity

s oy bean meal. The oil derived from MON 87769, however, has a unique fatty a cid profile and will be identity p reserved to maintain its value and assure its use in appropriate food applications. C ompared to commodity soy bean oil, SDA soy

bean oil contains two additional fatty

a cids, SDA and GLA. S DA soy bean oil is intended for use only i n certain markets. T he presence of this oil in markets where it is not intended could result in potential market and trade impacts. At the time SDA soy

bean oil is first introduced to the market, we do not expect that MON 87769 will have approvals in all key s oy bean export markets with functioning regulatory s ys tems. Until such approvals are received, MON 87769 will be grown and handl ed in a closed loop stewardship s ys tem (CL SS).

6 http://www.accessdata.fda.gov/scripts/fcn/gras_notices/grn000283.pdf 7 http://www.bio.org/lette rs/Product_Launch_Stewarship_12_10_09.pdf158

Monsanto will utilize and implement the CL SS throughout the initial product introduction phase, at least until approvals are received from key s oy bean export countries with functioning regulatory

sy stems. A ft er such approvals are received, Monsanto will, based on the experiences and learning gained during the initial product introduction phase under the CL SS, refine and update the stewardship sy stem for long - term implementation. This long - term sy stem will inc lude measures to preserve the identity o f this high value product and mitigation measures to minimize any

i mpact resulting from the inadvertent comingling of SDA soy beans or oil with commodity

or other specialty

soy bean products. This document describes the intended uses for SDA soy bean oil, current processes for handling vegetable oils, and potential impacts to commodity s oy bean oil as well as other vegetable oils from the commercial introduction of SDA soy bean oil. This document also describes the CL SS which Monsanto will implement during the initial phase of the product introduction . 

### 2. **Intended Uses SDA Soybean** MON 87769 is a sustainable source of omega - 3 fatty a cid for food use. S DA has fewer double bonds than other omega - 3 fatty a cids such as EPA (20:5) and DHA (22:6). T herefore, SDA soy bean oil is more stable to oxidation (i.e., less prone to fishy o r rancid odors and taste) compared to other oils containing EPA or DHA, thereb y expanding the potential formulation options for food companies and co nsumers. SDA soy bean oil is generally recognized as safe in the United States 8

. SDA is a metabolic precursor to the long chain omega - 3 fatty a cids, EPA and DHA, in humans and animals and is found in products such as fish and fish/algal oils. A lthough the benefits of omega - 3 fatty acid consumption are widely recognized, ty

pical Western diets contain very l ittle fatty f ish, while at the same time current foods and supplements provide limited alternatives to satisfy c onsumer demand for long chain omega - 3 f atty acids. An alternative approach to increase omega - 3 fatty

a cid intake is to provide a wider range of foods that are enriched in omega - 3 fatty acids so that people can choose foods that suit their usual dietary h abits. Human and animal studies have sh own that 1 g dietary SDA is approximately equivalent to 200 - 300 mg dietary E PA 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 i nt ake of long chain omega - 3 fatty a cids in food. SDA soy bean oil can be used for the production of margarine, shortenings, salad dressings, ready- to - eat foods, and other food categories described in the GRAS notification 9

. T he use of SDA soybean oil in sel ected food categories could provide a wide range of dietary alternatives for increasing omega - 3 fatty acid intake.

8 http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASListings/ucm185688.htm 9 http://www.accessdata.fda.gov/scripts/fcn/gras_notices/grn000283.pdf159

Given the targeted commercial application of SDA soy bean as an alternate source of omega - 3 fatty a cids in food it is anticipated that MON 8 7769 will be a low acreage product planned initially f or production in North America. The oil derived from MON 87769, however, has a unique fatty acid profile and will be identity p reserved to maintain its value and assure its use in appropriate food appl ications. The co - product, soy bean meal, derived from MON 87769 has been shown to be compositionally c omparable to other commodity s oy bean meal and will be used in a manner similar to commodity soy bean meal. As a food ingredient, SDA soy bean oil uses woul d be limited to those applications that demonstrate (1) functional suitability for incorporation into food products, (2) acceptable sensory properties (no off

- flavors or bad taste) to the food, and (3) appropriate stability p rofile and shelf life of food p roducts containing SDA soy bean oil during food production and storage. A s expected, SDA soy

bean oil from MON 87769 contains high levels of SDA (approximately 20 - 30 wt% of total fatty

a cids). V egetable oils containing high levels of poly unsaturated fatty acids (PUFUs) like SDA are known to undergo rapid oxidation during frying applications and will impart undesirable taste and odor to the fried foods. Therefore, SDA soy bean oil will not be suitable for all food applications and may not be suitable as a substitute for saturated fats in food recipes. H owever, SDA soy bean oil can partially

replace commodity

soy bean oil or other oils in many f ood categories. As is the case with fish oils, containing omega - 3 fatty acids, hydrogenation of SDA - containing oil wo uld be without purpose, as hydrogenation would eliminate the benefits of long chain pol yunsaturated fatty a cids (L CPUFAs). T hus, hydrogenation is not applicable to SDA soy bean oil from MON 87769. The current anticipated food applications for SDA soy bean oil are in baked goods and baking mixes, breakfast cereals and grains, cheeses, dairy p roduct analogs, fats and oils, fish products, frozen dairy d esserts and mixes, grain products and pastas, gravies and sauces, milk products, nuts and nut products, poultry p roducts, processed fruit juices, processed vegetable products, puddings and fillings, snack foods, soft candy, and soups and soup mixes 10

. 

### 3. Mark**et Potential of SDA Soybean** Consumer demand for long chain omega - 3 fatty a cids through food and supplements is expected to continue to grow . As of 2008, the United States omega - 3 ingredient market for marine oils was estimated at 26,447 metric tons (MT) per ye ar, with 13.8% of that volume being consumed in functional foods. F urthermore, the projected avera ge annual growth rate for this industry between 2008 and 2013 is 13.4% (Strategic Analy sis of the North American Marine and Algae Oil Omega - 3 In gredients Market, Frost & Sullivan, March 2010 11 ). The value added product derived from MON 87769 is SDA soy bean oil. SDA soy

bean oil provides increased alternatives

10 FDA Food classifications 21 CFR §170.3(n). 11 http://www.frost.com/prod/servlet/report - brochure.pag?id=N73E - 01 - 00 - 00 - 00160

for food companies to formulate omega - 3 fatty a cids into a wider range of foods. B ecause SDA soy bean oil can be used in wider food categories, Monsanto estimates, for the purposes of this anal ys is that the industry growth of omega - 3 oils in functional foods could increase by 2 6.6%. For the purposes of this anal ys is, Monsanto assumed that SDA soy bean oil could capture 100% of that incremental growth, which, given market dy namics, may

o ver estimate the demand for this oil. S DA soy

bean oil will ty

picall y 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 c ontain about 30% long chain omega - 3 fatty a cids (James et al., 2003 and Lemke et al., 2010). As a result, it is expected that about 7.5 times the volume of SDA soy bean oil might be needed to satisfy the EPA equivalent amount currently provided by

other marine oils. Under such a scenario, and assuming this growth is sustaine d at that constant level through 2016 the incremental amount of SDA soy bean oil needed to satisfy that 26.6% industry growth would be approximately 2 0,000 MT. Furthermore, assuming an average oil yi eld of 0.2 MT/acre for soy bean, this would equate to around 100,000 acres per ye ar of SDA soy bean needed to be grown to satisfy the U.S. demand for SDA soy

bean oil derived from MON 87769. It is foreseeable that global market demands for omega - 3 containing foods may a ugment the U.S. soy

bean acres grown with MON 87769 for the purposes of SDA soy

bean and/or SDA soy

bean oil exports. The United States is the largest producer of soy

beans and regularly

e xports soy

bean and soy

bean products to global markets. In 2010 approximately

7 5 million acres of soy bean crop was grown in the U.S. producing approximately

87 million MT of soy

beans. 

### 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 BI O's Product Launch Stewardship Policy , Monsanto considered Annex 2 “Special Use Traits in Commodity C rops” to develop launch plans for SDA soy bean including: (1) identifying relevant stakeholders for the trait and crop and engaging them in dialogue and outreach regarding use of SDA soy bean, (2) conducting a market and trade assessment to evaluate the potential impact from the introduction of MON 87769 to the market place, and (3) implementing a closed loop stewardship sy stem to direc t 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 i ndustry s takeholder groups and has held several meetings with the Nation al Oil Processors Association (NOPA) as well as other key i ndustry associations such as the North American Export Grain Association (NAEGA), National Grain

12 http://www .monsanto.com/ourcommitments/pages/product - stewardship.aspx 13 http://www.bio.org/letters/Product_Launch_Stewarship_12_10_09.pdf ;161

and Feed Association (NGFA), National Agri - Marketing Association (NAMA), American Bakers Association (ABA), and Grocery M anufacturers Association (GMA). Soy bean grower organizations consulted include: American Soy bean Association (ASA), United States Soy bean Board (USB), and many s tate soy

bean associations. A dditionally , Monsanto has kept QUALISOY, a c ollaborative program sponsored by U SB that serves as an independent third party r esource for information on trait - enhanced soy bean oils, informed of the plans for this product, along with dietary and nutrition thought leaders. M onsanto continues to have c onversations with, and considers the input of several soy bean and food industry k ey stakeholders regarding the oil composition, stewardship plan and performance of MON 87769 oil. Monsanto has been marketing specialty V istive low linolenic soy beans to growers since 2005. As grower and market demand for this specialty soy bean product has grown, we have continued to work with processors to assure adequate testing methods and quality p rocesses are applied to assure that the commodity s oy bean suppl y stream is n ot impacted. At a minimum, the same outreach, education, and quality p rinciples will be applied as we further develop SDA soy bean stewardship and commercialization plan. These quality s ys tems are described in the following sections. **4.2 Market and Tra de Assessment**  Approximately

8 5 million MT of soy

beans are produced in the U.S. annually and the U.S. is a leading exporter of soy

bean, soy bean meal and soy

bean oil to global markets. Approximately 12% of soy

bean grown is specialty

s oy bean produced for a s pecific market or use 14

. T hese soy bean varieties are specified by buyers and end - users of so ybean for production, and premiums are paid for delivering a product that meets purity and quality s tandards of that soy

bean variety. The specialty , value - added, p roduct may b e the whole soy

bean or, in the case of MON 87769, a processed fraction such as the oil. P roduct differentiation and market segmentation in the specialty s oy bean industry

i ncludes mechanisms to keep track of the soy bean (traceability), methods for identity

p reservation ( IP ), including closed - loop stewardship sy stems, and quality assurance processes (e.g., I SO9001 - 2000 certification), as well as contracts between growers and buyers that specify

delivery agreements within product specifications. M onsanto has conducted a market and trade assessment to anticipate and consider the potential impacts within the value chain from the introduction of SDA soy bean, and to commodity soy bean oil as well as other vegetable oil in the market place. S oy bean is a globally

traded commodity

w ith the U.S. being the top global producer 15

. B iotechnology- derived crops are

14 http://usb.adayana.com:8080/usb/jsp/login.jsp . Percent U.S. Soybean acreage estimate based on U.S. Domestic Consumption by Segment

– 2008/09. D. Ludwig, personal communication, 2009. 15 http://www.soyatech.com/oilseed_statistics.htm162

subject to regulation in many c ountries. In order to support free trade in soy bean, Monsanto is pursuing regulatory

a pproval for MON 87769 and any st acked products intended for commercialization in all key s oy bean export countries with a functioning regulatory s ys tem. International regulatory

a uthorities are evaluating the food and feed safety o f MON 87769 as well as the processed fractions derived from MON 87769. It is expected that uses of SDA soy bean oil would be similar on a global basis. D efatted soy bean meal from MON 87769 is similar to commodity

s oy bean meal and therefore it can be comingled with commodity s oy bean meal upon gaining regulatory approval from all key s oy bean export countries that have functioning regulatory

s ystems. The stewardship sy stem will be designed to prevent the comingling of SDA soy bean or oil with commodity

p roducts. T he market and trade assessment supports the conclusion that in the unlikely e vent that comingling of SDA soy bean or oil in the commodity s tream did occur, the impact would be minimal. S ections 4.2.1, 4.2.2 and 4.2.3 below discuss in detail the potential impacts of inadvertent comingling of SDA soy b ean, oil, and meal with commodity s oy bean, oil, and meal in the market place and show that any s uch comingling would have onl y minimal impact to current soy

bean and vegetable oil markets. As discussed earlier, the SDA soy bean and oil are for a specialty m arket and are not meant to be part of the commodity c hain. The comingling scenarios and impacts are presented as worst case situations. Oilseed processors and users of vegetable oils are accustomed to the presence of numerous vegetable oils that are currentl y available for various food applications. The comingling levels where an impact would occur could onl y happen if there were a major deviation in the sy stem which is highl y unlikel y as routine anal yt ical methods are in place. A dditionally, there is e conomic motivation, legal contracts, standard operating procedures (seed quality t o end user), and demonstrated competency

handling other vegetable oils of similar fatty acid profiles. **4.2.1 Potential Impact to Commodity Soybean in the Market Place**  The impact from comingling was assessed based on the following , scenario: An inadvertent unloading of a truck containing 100% SDA soy bean into the commodity stream at an elevator or processor where the event goes unnoticed. This scenario was chosen because i t represents a “worst case” situation. T his is unlikely t o occur because a farmer producing SDA soy beans is financiall y motivated to identity p reserve the SDA soy

bean from commodity

s oy bean during harvest to realize the premium paid upon delivery . F urthe r, comingling can be identified via routine fatty

a cid anal ys is or QC checks before the oil is shipped from the processing facility . All soy bean oil is analyzed by

g as chromatography

( GC) to determine the fatty a cid profile prior to shipping. This information is placed on the “Certificate of Anal ys is” (CofA) accompanyi ng the shipment. Any

c ommingling of commodity o il with SDA soy

bean oil should be identified prior to loading for export shipment, which minimizes commingled oil arriving at an exporting country .163

For the purposes of this anal ys is, the following assumptions were made: the load limit on roads in most soy

bean producing states is 80,000 lbs gross weight. The empty w eight of most semi trucks is at or below 35,000 lbs, leaving a load capacity o f 45 ,000 lbs (the difference). At 60 lbs per bushel, a standard semi truck will haul less than 800 bushels of soy beans. Thus, this commingling scenario assumes 800 bushels of SDA soy bean commingled with commodity soy bean. Upon processing of the comingled soy beans, 800 bushels of SDA soy beans would yi eld approximately

8 000 lbs of refined SDA soy bean oil. The capacity

o f the smallest soy

bean oil holding tank at U.S. processing plants is approximately 2 00,000 lbs. Thus the accidental comingling of the truck lo ad of SDA soy bean will result in a 25X dilution of SDA soy bean oil in a 200,000 lb tank of commodity soy bean oil. In this situation, 8000 lbs of 20% SDA soy bean oil will be diluted to 200,000 lb resulting in a final SDA concentration of 0.8% SDA in commodity soy bean oil. T he presence of 0.8% SDA in commodity s oy bean oil will have no impact to 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 o f 800 bushels of SDA soy bean to a grain elevator. In this case **,** the SDA soy

bean would be diluted with commodity soy bean in a grain storage bin that ty picall y holds 100,000 to 500,000 bushels of soy bean, resulting in 125X to 625X dilution of SDA soy bean in commodity

s oy bean. The commodity s oy bean oil produced from this comingling scenario will only have SDA ranging from 0.03% to 0.16% of total fatty acids. Soy beans are exported as whole beans or as processed fr actions. S oy bean oil is commonly exported via cargo ships in containers with a capacity of approximately 4 0,000 lbs. T hese oil filled containers are transferred from the cargo ships to trucks at the importing ports. If a container of SDA soy

bean oil unintentionally

ends up in a port where it is not suppose to be, it can be identified and diverted back to the country of origin or to another importing country . Due to the CofA and the high value of the product, the chance of SDA in soy bean oil entering into the export market unintentionally is very small. Commodity

s oy bean shipped for export are ty pically l oaded into unit trains (360,000 bushels) or barges (50,000 bushels/barge) that eventuall y are loaded into 2 million bushel ocean going vessels. B efore a ship loaded with commodity soy bean reaches a destination country , the inadvertent delivery

o f a truck containing 800 bushels would be mixed and diluted within 2 million bushels. The amount of SDA soy bean in the vessel would be less than 0.04% of the total amount, or 2500X dilution. T he soy bean oil produced from this commingled soy bean will have

16 http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASListings/ucm185688.htm164

SDA at level below 0.008% of total fatty a cids, which is the more than six time below the CODEX limit of quantitation for fatty acids in vegetable oil (0.05%). **4. 2.2**  **Potential Impact to Commodity Soybean Meal in the Market Place** Monsanto provided information to USDA in the petition demonstrating that the composition of the meal from MON 87769 is equivalent to meal derived from conventional soy bean and safe and who lesome for food or feed applications as commodity s oy bean meal. D efatted SDA soy bean meal contains approximately 1% residual oil. A ccording to the National Oil Processors Association defatted soy bean meal should contain a minimum of 0.5% oil to meet qual ity standards and guidelines for soy bean meal from domestic and international shipping (NOPA, 2006). With the exception of the presence of minor amounts of the Pj  6D and Nc  15D proteins and de minimis amounts of residual oil, the soy bean meal and other non - oil processed fractions used for animal feed and human food applications are unchanged from commodity p rocessed soy bean fractions. Upon receiving regulatory approval for MON 87769 in all major soy be an export countries, SDA soy bean meal can be comingled with commodity s oy bean meal in the market place. T herefore no trade impact is anticipated from the commingling of SDA soy bean meal with commodity

soy bean meal. **4.2.3 Potential Impact to Commodity So**  **ybean Oil in the Market Place** Monsanto has assessed the impact due to the presence of SDA soy bean oil on commodity

and other vegetable oils. Areas of potential impact identified include the following: (1) food ingredient labeling, (2) nutritional facts p anel labeling (3) functionality of the oil, and (4) sensory e valuation. T his assessment has been shared with key s takeholders such as NOPA, NAEGA, ASA, QUALISOY, USB and GMA. **Food Ingredient Labeling:** The impact due to the presence of SDA soy bean oil in commodity

s oy bean oil from the perspective of soy

bean oil ingredient labeling was considered. S DA soy bean oil contains two additional fatty acids (SDA and GLA) that are not present in commodity soy bean oil. Therefore, we evaluated the potential impact to food ingredient labeling if SDA soy bean oil was inadvertentl y present in the soybean oil that is added to food. The U.S. Food and Drug Administration requires that all ingredients present in a food to be declared with a few exceptions. Although the regulations do not explicitly define “ingredient” they do discuss a class of “incidental additives” that are not considered ingredients and yet can be present in a food. An “incidental additive” is exempt if, according to the regulations, it is165

present at “insignificant levels” and has no “technical or functional effect” in a food 17 . Residual product from a previous soy bean oil processing run may occasionall y be mixed into a different product in a new run. Such residual product would fit the concept of “incidental additive” 18 and need not be included on the label. Thus, the unintended presence of insignificant amounts of SDA soy bean oil in soy

bean oil is tolerated under the food label laws and should not impact the ingredient labeling of soy bean oil or foo ds containing such oil. **Nutrition Facts Panel Labeling:** The FDA requires that information on fats to be declared on the nutrition facts panel of foods. They are (1) total fat, (2) trans fat, and (3) saturated fat. It is voluntary for a food company

t o list the amounts of monounsaturated fat and pol yunsaturated fat on the nutrition facts panel. T he nutrition facts panel of SDA soy bean oil will be similar to commodity s oy bean oil because the total fat, saturated fat and trans fat content of SDA soy bean oil is similar to commodity s oy bean oil. Many

v egetable oil providers voluntaril y list also monounsaturated and pol yunsaturated fatty a cids present in the oil. S ince in SDA soy bean oil one poly

unsaturated fatty

a cid (LA) is replaced with two other (SDA and GLA) poly unsaturated fatty acids; the impact of comingling on nutrition facts panel labeling from listing mono and pol yunsaturated fatty a cid is negligible. Even though bottled SDA soy bean oil is not an intended use at this time, a worst case assessment using 100% commodity soy bean oil was considered to assess the potential impact of SDA soy bean oil comingling with commodity soy bean oil on nutritional facts panel labeling of bottled soy bean oil. T able 1 shows the amount of SDA soy bean oil that would b e needed to be comingled with commodity bottled soy

bean oil in order to significantly impact the nutrition facts panel for major fatty

a cids on bottled soy

bean oil. B ased on this analy sis even 25% of SDA soy bean oil comingled with commodity s oy bean oil wi ll not significantly impact the nutritional facts panel label for soy

bean oil. T his example illustrates that any incidental presence of SDA soy bean oil in commodity

s oy bean oil will not have any impact on the nutritional labeling of soy bean oil or SDA soy

bean oil containing food products. F igure 1 shows the ty pical nutrition facts panel for commodity soy bean oil (100 % soybean oil) and a theoretical nutrition facts panel for SDA so ybean oil.

17 21 CFR § 101.100 18 21 CFR § 101.100 (3)i166

**Table 1. Impact of Comingling SDA Soybean Oil with Commodi ty 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=Soy

bean Oil Note: The impact of mixing SDA soy bean oil (SDA SBO) on nutritional facts labeling for bottled soy

bean oil (SBO) is depicted in the table above. The impact to nutritional facts panel labeling was assessed at various percentages of SDA soy bean oil mixed with commodity

soy bean oil. 14 g serving size and FCC rounding rules applied. GLA and SDA included in poly unsaturated fatty acid calcul ation. Mono and poly unsaturated fatty acid labeling is voluntary . No change in trans fat.167

**Figure 1. Nutrition Facts Panel for Commodity Soybean Oil and Theoretical Nutrition Facts Panel for SDA Soybean Oil** 

**Note:** Nutrition facts panel generated using Genesis SQLR&D software (© 2011 ESHA Research), the same as used ty pically by food companies. Commodity soy bean oil exists in the database. SDA soy bean oil’s ty

pical fatty acid composition was utilized to develop a theoretical nutrition facts panel. 

## 100% Soybean Oil 100% SD A Soybean Oil168

**Oil Functionality: Oxidative**  **Stability** Monsanto conducted an assessment of the impact of the oxidative stability of commodity

s oy bean oil comingl ed with SDA soy bean oil. F igure 2 demonstrates that comingling of SDA soy

bean oil with commodity s oy bean oil decreases the Oxidative Stability Index (OSI) of commodity s oy bean oil. T he OSI stability i ndex is an indicator of soy bean oil stability . A ll oi ls and fats have a resistance to oxidation, which depends on the degree of saturation, antioxidant and pro - oxidant concentration, and prior abuse. Oxidation is slow until this resistance is overcome, at which point oxidation accelerates and becomes more rapid. The length of time prior to the acceleration of oxidation is referred to as the ‘induction period,’ and the point of maximum rate change is referred to as the OSI, and is reported in hours. The oxidative stability

o f soy bean oil is significantly i n fluenced by

the proportion of monounsaturates to polyunsaturates. To assess the impact of comingling on the OSI, the OSI of 21 commercially available soy

bean oil as well as blends of commodity soy bean oil with SDA soy

bean oil were evaluated. Commodity

/S DA so ybean oil blends were prepared in duplicate (wt./wt.) using SDA so ybean oil in retail salad oil (so ybean oil) obtained from a local St. L ouis market. Neither oils contained added antioxidants. SDA soy bean 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. OSIwas run in duplicate for each blend sample, and means were averaged to obtain the data p oints shown. Target blend accuracy in the commodity

/SDA soy bean oil blends was confirmed by fatty acid composition determined using capillary

gas chromatographic (GC) anal ys is (data not shown). The “Commercial so y” range shown in Figure 2 represents 21 unstabilized salad oils that were obtained at retail markets in St. L ouis over a 3 year period and analyzed for OSIwithin 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 oil s ranged from 5.63 to 9.68 with a median value of 6.66. SDA soy bean oil is estimated to have decreased oxidative stability compared to conventional soy bean oil (Figure 2). Based on this study it is reasonable to conclude that minor levels of SDA will not impact the OSI index of commodity

soy bean oil. At comingling levels of 12.5% of SDA soy bean oil in commodity soy bean oil, the OSI index falls below the range observed for commercial soy bean oils.169

**Figure 2** . **Oxidative Stability Index (OSI) of SDA Soybea n Oil Blended with Commodity**  **Soybean Oil**

**Heat Treatment** Vegetable oils containing high levels of PUFA are known to undergo rapid oxidation during frying applications and are known to impart undesirable taste and odor to the fried foods. SDA so ybean oil contains relatively high levels of PUFAs compared to other vegetable oils, and therefore, is not intended for frying applications. However, as part of the evaluation of the potential impact of SDA soy bean oil on the functional properties of commodity soy bean oil, the influence of SDA soy bean oil on the ability of fry oil to withstand heat treatment was determined. From a practical standpoint, commercial fryers use the level of polar materials formed during frying as a measure of oxidation and to determine the fry life of oil. Total polar material values are of

ten 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 compoun ds are by products that are generated as the oil degrades in quality . A common means of measuring total polar material in oils is by the use of the Ebro Food Oil Meter (Ebro International, Lino Lakes, MN). As oil degrades during frying, there is an increa se in the polar materials that affect the dielectric constant of the oil. Measurements are taken of the fry oil throughout the length of the fry study to determine when the oil has reached 24% total polar material (TPM), which ty picall y indicates the need to discard the oil. Figure 3 shows the time in hours that it took for each SDA so yb ean oil/commodity soy bean oil blend to reach 24% TPM during frying. The results indicate within the range of blends tested the level of SDA so ybean oil had minimal impact on the formation of total polar materials in the oil. 

## OSI r ange fo r 21 **12.5% SD A Soybean**  **oil** • **0% SD A**  **Soybean Oil**

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

**% SDA Oil in Commodity Soybean Oil**

• **100% SD A**  **Soybean Oil**170

**Figure 3. Hours to Reach 24% Total Polar Material During Frying Application of Soybean Oil Containing Varying Amounts of SDA SoybeanOil** 

**Food Sensory Assessment:** A sensory

assessment of SDA soy

bean oil was performed to evaluate consumer acceptability of SDA soy bean oil. Sensory

assessment has concluded that the sensory attributes of SDA soy

bean oil is comparable to commodity soy bean oil. Even though SDA soy bean oil is not intended for frying application, sensory results for SDA soy

bean oil in the most challenging environment of high temperature food frying applications was evaluated as a worst case scenario. To determine the impact SDA soy

bean oil on the quality

of foods prepared from blends of SDA soy bean oil and commodity

soy bean oil, french fries were prepared. The five oil blends (ranging from 2.5 to 15% SDA soy

bean oil) and commodity soy bean 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 S ys tem method (King et al., 2002). Each panelist was provided a control fry

and test fry

and asked to rate the overall quality score (overall difference) along with the differences in individual French fry attributes. A rating of 5 in dicates no difference, 4 slight difference, 3 difference, 2 significant difference and 1 extremely different. Figure 4 shows the results from this study . The outcome from the sensory evaluation showed that up to 15% of SDA soy bean oil can be comingled wi th commodity soybean oil without impacting the flavor perception of fried food (Figure 4). 

## % **SD A**  **Soyb ean**  **oil in Soyb**  **ean Oil** 171

**Figure 4. Sensory Results from Frying Applications of Soybean oil Containing Varying Amounts of SDA Soybean Oil.**

Ratings: 5 = No Difference; 0 = C ompletely different 0.0% SDA SBO 2.5% SDA SBO 5.0% SDA SBO 7.5% SDA SBO 10% SDA SBO 15% SDA SBO 

## Rating

**Da ys** 172

The market and trade assessment has concluded that in the unlikel y event comingling did occur, the impact to labeling and functionality of commodity

soy bean oil would be minimal. Monsanto will have an a

ppropriate stewardship plan in place to direct MON 87769 and oil to its intended markets, both in its initial commercial phase when produced and used under CL SS as well as longer - term. **4.3 Risk Mitigation Plan 4.3.1 Stewardship Plan for MON 87769**  **- Closed Loop Stewardship System**  To mitigate potential impacts to commodity s oy bean, a Closed Loop Stewardship Sy stem (CL SS) has been developed to support the commercialization of SDA soybean prior to obtaining approvals in key

s oy bean export markets with functioning regulatory s ys tems. The CL SS defines procedures and processes relevant to the production, handling, and processing of all stewarded materials generated within the closed loop. S tewarded materials include viable soy bean seed and grain, meal, hulls, oil, and downstream co - prod ucts derived from the crude oil that are in direct control of Monsanto, its licensees or partners, and their customers. M onsanto will continue to utilize the CL SS through the initial product introduction phase until necessary global approvals are received from key s oy bean export countries with functioning regulatory sy stems. A fter the approvals are received, Monsanto will refine and update the stewardship sy stem for long - term implementation based on the experience developed during the introduction phase and in consultation with key stakeholders. Under the CL SS, Monsanto will develop and implement best practices and sy stems consistent with the Excellence Through Stewardship 19 initiative. M onsanto will carefull y evaluate capabilities of partners and downstream entities to contain downstream products to their intended market(s) and include terms and conditions in agreements with those partners or entities. T hese agreements will require that appropriate quality management sy stems (QMS), including both quality assurance (QA) and quality c ontrol (QC), are in place to manage and verify c ontainment of all stewarded materials in countries of production and use. Monsanto will only

w ork with downstream partners that have proven traceability , identity preservation, and CLSS production capabilities. Monsanto , its licensees, partners and processors will implement an annual auditing process for material under their control. C ommercial production of soy

bean seed for planting and harvested soy bean and the subsequent proc essing or manufacturing of stewarded end use products requires strict adherence to established processes under the CL SS to ensure each material is handled and used appropriately . If any part of the process is contracted out to a third party , Monsanto will require a Stewardship Management Plan

19 Excellence Through Stewardship (ETS) is an initiative to promote the global adoption of stewardship programs and quality management systems for the full life cycle of biotechnology - derived plant products .173

that meets CL SS standards. M onsanto reserves the right to audit these plans directly o r through a third party. Activities under the CL SS are organized into five relevant sections identifying critical control points: (1) Production of SDA Soy bean Seed for Planting, (2) Production of SDA Soy bean for Processing, (3) SDA So ybean Processing and Oil Refining, (4) SDA Soybean Oil Packaging and Storage, and (5) SDA Soybean Oil Distribution to Food Company Supply Chain. The i nformation presented in each section describes the purpose, scope, and procedures necessary to conduct and verify

the proper handling and use of all relevant materials under the CL SS.174

**Figure 5. Parts of the Closed Loop Stewardship System and Critical Control Points**  **Grain Processing &**  **Oil Refining 3**  **Seed Production**  **1 Food**  **Company Distribution**  **5 Grain**  **Production 2**  **Oil P ackaging**  **& Storage**

**Grain Elevator**  **4** Contracts and Agreements Segregated Storage Analytical T

es ting SOPs 1 Monsanto contracts approximately 1 M acres of soybean seed production each year produced under ISO 9000 Standards 2 Contract production with processor – on farm storage and segregation – analysis of grain upon delivery to pr ocessor or grain elevator 3 Grower deliv er s to a processor , on - site segregated storage, analytical testing conducted 4 Grower deliv er s to e levator , analytical tes ting methods on - site, elevator holds soybeans until called by processor 5 Food Co handles multiple vegetable oil ingredients, segregated storage, formulation supported by analytical methods, SOP ’s in place to assure product quality175

The requirements and processes for activities at each of these control points under a CL SS are consistent with Monsanto stewardship guidelines. These guidelines include processes to prevent commingling with commodity soy bean seed, soy

bean, and oil (e.g. isolation, equipment cleaning and segregated storage). A ll Monsanto and non - Monsanto personnel involved with producing material under the CL SS are required to follow these guidelines and requirements. **De tection**  **Methods** Monsanto has developed event - specific detection methods to detect the MON 87769 event in articles of commerce including soy bean seed, harvested soy bean, soy bean meal and oil. M ore importantly , Monsanto has developed anal ytical methods to a ssess the fatty acid profile for SDA soy bean oil as well as detect the presence of SDA in vegetable oil. Monsanto will provide these methods to the industry u pon request. O il processors and downstream distributors are accustomed to using oil analy sis methods during their normal course of business. Fatty acid profile anal ys es of soy bean oil are considered routine within the industry . **Production of SDA Soybean Seed for Planting:** Monsanto is a leader in crop biotechnology h aving successfull y introduced numerous biotechnology- derived crops to the marketplace globall y. M onsanto has developed and implemented seed quality s tandards and practices to validate soy bean seed meets the standards established for purity

of a trait. T hese standards apply to all soy be an seed sold by

Monsanto and are based upon measures that seed producers put in place to assure the genetic purity of improved planting seed. This sy stem is used to assure that farmers receive seed of known quality with a minimum level of off typ e seeds. The first step in production of SDA soy bean is the production, processing and delivery o f high quality p arent seed to the grower. M onsanto’s seed manufacturing organization uses specific SOPs and documentation forms to ensure compliance with Monsanto stew ardship and compliance standards. T he entire seed production process at the majority of the seed companies and tollers operates using International Organization for Standardization20 (I SO) certification standards and include internal and external audits (I SO, 2009). B y following ISO quality standards it is possible to validate that the processes are followed which have been designed to generate the desirable characteristics of seeds and services such as quality , safety , reliability , and efficiency . T he IS O standards represent an international consensus on good management practices with the aim of ensuring that the organization can consistently deliver excellent product or services. T he standards not only must meet the customer’s requirements and applicabl e seed regulatory

requirements, but also must aim to enhance customer satisfaction and achieve continual improvement of its performance in pursuit of these objectives (ISO, 2009).

20http://www.iso.org/iso/ims_2009.htm176

Commercially

c ertified soy

bean seed must meet state and federal seed standards and labeling requirements. T he Association of Official Seed Certifying Agencies (AOSCA) standards for certified soy

bean seed are as follows: 9 8% pure seed (minimum), 2% inert matter (maximum). The inert matter can contain up to 0.05% weed seed (maximum, not to exceed 10 per lb.), 0.60% total of other crop seeds (maximum), 0.5% other varieties (maximum, includes off - colored beans and off - ty pe seeds), 0.10% other crop seeds (maximum, not to exceed three per lb.), and have 80% germination and hard seed (minimum) (AOSCA, 2009). S eed that meets or exceeds these standards are provided in appropriatel y labeled seed bags to growers. M onsanto’s seed manufacturing practices for MON 87769 will be designed to contain MON 87769 within the boundaries of the produc tion sy stem thereby a ssuring that levels of the trait and the subsequent SDA and GLA fatty

a cids do not cause impacts to conventional soy beans or other commodity soy bean varieties produced at seed manufacturing sites. **Production of SDA Soybean for Processi ng:**  SDA soy bean will be produced under contracts similar to those currently issued by

processors or elevators for commercial specialty s oy bean such as food grade, organic, Vistive low linolenic or other specialty so ybeans. The income opportunity is achieved by the farmer onl y when the soy bean is delivered to the processor within specifications. T herefore, the motivation is a financial incentive for the farmer to avoid comingling with commodity s oy bean, keeping SDA soy

bean identity

p reserved within s ys tem of seed

– farmer

– processor. M any farmers may w illingl y choose to plant all their acreage to specialty soy

beans because it eliminates any risk of comingling that may occur during the harvest. I f a farmer chooses to produce the specialty soy bean fo r the processor, the farmer will arrange to store the soy bean on farm or at their local elevator, if the elevator is participating in the specialty

program with the processor. The steps involved in securing so ybean production are: 1. Monsanto, its licensees, partners or processors will be responsible to issue production contracts. These contracts will be either to an elevator or directl y to the farmer. If issued to an elevator, the elevator will in turn issue contracts with farmer customers in the amount of acreage established in its processor contract. The contract will include number of acres and the timeline for the delivery of harvested soy

beans. 2. Monsanto, its licensees or partners will distribute SDA soy bean seed to the farmer after verifying that the f

armer has a valid contract that has been issued for SDA soy bean production and stewardship in their operation. This will include an amount of seed needed to plant the number of acres established on the production contract by the processor or elevator. 3. Mon santo, its licensees or partners will work with all parties involved to confirm and reconcile acres contracted with seed sales. P rocessors can plan processing schedules177

according to demand of the oil and supply o f SDA soy

bean anticipated from contracted f armers. 4. After harvest, the farmer will deliver the harvested SDA soy bean to the location specified in his contract, either a participating elevator or processor. I f delivered to the elevator, the elevator will keep the SDA soy bean segregated from commodity soy bean and pay

the farmer any premiums as applicable, provided it passes the analy tical testing. The elevator will deliver the SDA soy bean to the processor as delivery w indows and crush schedules have been established. Upon delivery o f SDA soy

bean by the farmer, samples will be analy

zed from every

truckload. This is to confirm the soy bean contains the SDA trait as required by

the production contract. Upon confirmation that the SDA soy bean meets specification, the processor or elevator will approve th e premium paym ent to the farmer. S DA soy

bean that does not meet specifications at the elevator or processor will be segregated, processed and the oil will be directed to appropriate uses such as for the production of biofuel . **Soybean Grain Elevator** Grain elevators play an important role in specialty programs with their long term storage of the soy beans. B ecause processing facilities crush soy beans throughout the ye ar, soy beans used to supply

these crush plants need to be stored ye ar round. Farmers ty pically prefer to empty

their storage prior to planting of the new crop and prior to temperature warm up in the spring. T he warm spring and summer weather presents challenges as condensation can build up in the bins creating moisture - related issues that make soy bean - eating insects more active. T o avoid this, commercial elevators have expert grain managers on staff to monitor soy bean quality

and keep soy

bean in good condition in all weather situations throughout the ye ar. C ommercial grain elevators are also b etter equipped to ship soy beans to processors during times of severe weather even when farmers cannot get to their bins. Processors will therefore enter into supply c ontracts with commercial grain elevators and work with farmers to establish inventories and to assure proper routing of SDA soy bean through the supply c hain. T he elevator pay s the farmer the specialty s oy bean premium upon successful anal yt ical testing performed at the elevator location. T esting equipment will be provided as needed b y Monsant o to participating elevators. In order for the elevator to be reimbursed for the premiums paid out to farmers that have delivered SDA soy

beans to them, the elevator must in turn preserve the identity o f the soy

bean as it is delivered to the processor. Every l oad delivered to the processor by the elevator will be anal yz ed to make this determination. P rocessors will approve the premium pay ment to the elevator after anal ys is of the soy bean to confirm the SDA trait. SDA soy bean that does not meet specifications at the elevator or processor will be segregated, processed and the oil will be directed to appropriate uses such as for the production of biofuel .178

**SDA Soybean Processing and Oil Refining:** All SDA soy

bean processors must be approved in advance by Monsanto. In order for the processor to be approved by M onsanto to process SDA soy bean, certain requirements must be met. They

must posses the ability

to store, segregate and identity preserve SDA soy

beans. T hey must demonstrate the ability to clean the equipment associated with the receiving and subsequent handling of SDA soy

beans. T he processor’s facility must have procedures in place and the ability t o assure that SDA soy bean processing, extracting, and oil refining equipments can be flushed to comme rciall y acceptable standards after processing SDA soy beans. Monsanto and the processor will enter into an agreement to establish the terms and conditions of SDA soy bean processing services. T hese agreements will also include terms for distribution of SDA soy bean co - products resulting from processing as stewarded products within the United States prior to receiving necessary

regulatory

a pprovals in soy

bean export markets. The resulting oil from processing SDA so ybean is generall y recognized as safe in the United States. Upon the transition from commodity s oy beans to the SDA soy

beans, a sample of crude oil is required to confirm the presence of the appropriate fatty a cid composition (FAC) unique to SDA soy bean oil. Crude oil will be collected and handled in a way that ensures that any

SDA soy bean oil as well as SDA soy bean oil comingled with commodity s oy bean oil are handled in an appropriate manner and segregated from other oils. This will include all comingled oil before and after the collection of SDA soy bean oil. T esting methods will be used to aid in identifying the appropriate time to start and stop collecting crude SDA soy bean oil. Storage tanks approved for SDA soy

bean oil will be assigned for the storage of crude and refined SDA soy bean oil. Upon the completion of SDA soy bean processing, a commodity s oy bean flush will be initiated. After all SDA soy

bean and commodity

s oy bean used to flush the channels have been processed, crude oil exiting the ex tractor will be sampled and analyzed to confirm the equipment has been flushed to an acceptable level, yi elding commercially a cceptable commodity

s oy bean oil. O ff

spec, commingled or flush SDA soy bean oil will be segregated from commodity soy bean oil and directed to appropriate use such as for the prod uction of biofuel. **SDA Soybean Oil Packaging and Storage:** Soy bean oil produced under the CL SS will be distributed as a stewarded product within the United States until receiving approvals in all key soy bean export markets. An agreement will be executed b etween Monsanto, its licensees, partners, the processor and/or the packager to establish the terms and conditions for packaging stewarded SDA soy bean oil at a contract packaging facility . As eparate agreement will be executed with a long - term storage faci lity , if used, to establish the terms and conditions for SDA soy bean oil receipt, storage, and distribution. Bulk liquid semi - trailers (tankers) will be used to transport packaged and/or bulk SDA soy bean oil. R efined, bleached, and deodorized (RBD) SDA soy bean oil packaging will be conducted in an area that is clean, secure, and segregated to eliminate potential comingling with commodity179

soy bean and/or other vegetable oils. The containers will be properly l abeled using predetermined methods that will in clude chain of custody d ocumentation. P eriodic visual inspections will occur in and around the packaging area for the collection and disposal of any spilled oil or damaged containers. A ll semi - trailers used in the transportation of bulk SDA soy bean oil w ill be verified to be clean at the processing plant or other Monsanto approved facility p rior to being released. A fter packaging is complete, the facility will be flushed with adequate amounts of commodity s oy bean oil to remove SDA soy bean oil and return the oil stream to commodity

s oy bean oil specifications. F lush oil containing SDA soy bean oil will be segregated and directed to appropriate use such as for the production of biofuel. **SDA Soybean Oil Distribution to Food Company Supply Chain:** Monsanto, its licensees and/or partners will execute agreements with food companies to establish the terms and conditions for the use of stewarded SDA soy bean oil. D uring the development of these contracts, it will be necessary t o verify that the food companies have the capabilities in place to control and limit distribution of stewarded products and track all products that use specific batches of the SDA soy bean oil as ingredient. These contracts will include stewardship obligations and will require compliance including auditing. Third party c onsultants will be used if necessary

under the CL SS. T hese third party consultants will have expertise in suppl y and demand chain procedures, to enable verification of a food company’ s capabilities. SDA soy bean oil will be used by

the food industry

and will be supplied to specific customers by Monsanto, its licensees or partners and suppliers after verifying that it meets specific customer requirements including quality factors. From the time the oil is packaged until it is utilized at the specific customer’s facility there will be proper identification of the oil through labeling and manufacturing codes allowing for sufficient product traceability. Individual facilities will utilize proprietary

i nventory

and ordering sy ste ms that are in place to insure that the appropriate oil is ordered, delivered and utilized. Food companies will use SDA soy bean oil as a food ingredient consistent with the GRAS notification21

. E ach individual food company has in place sy stems for ingredie nt (oil) ordering, receipt, storage, access and lot identification at specific manufacturing locations, as well as finished product (the food which incorporates SDA soy bean oil) batch identification, manufacturing facility , storage, shipment to distributio n centers, customer order picking, customer order shipment and receipt. Appropriate procedures are currently i n place to ensure traceability

f rom receipt of the ingredient through distribution to a specific retailer’s facility . Food manufacturing facilities also comply w ith federal and state requirements for good

21 http://www.accessdata.fda.go v/scripts/fcn/gras_notices/grn000283.pdf180

manufacturing practices and product traceability. Supply c hain consultants can be employed to confirm appropriate sy stems have been established that meet ingredient and product traceability requirements. **Incident Response** All activities conducted by M onsanto and non - Monsanto personnel under the scope of the CL SS must be consistent with Monsanto’s corporate expectations for regulatory and stewardship compliance prior to obtaining all relevant glob al regulatory approvals. Monsanto has an incident response policy

i n place. I f an unforeseen process failure or a breach of containment of stewarded material occurs, the CL SS incident response would be managed according to Monsanto’s Global Product Stewardship and Quality p rocess and procedures document. The In cident Response Process engages a multi - disciplinary t eam for immediate response investigation, assessment and mitigation of any potential adverse impacts that could result from the process failure. The incident investigation and analy sis process will determine the reason for the occurrence and develop recommendations for corrective action including process improvement to prevent similar occurrences in the future. **Development of Long Term Stewards hip Processes**  The CL SS described above to support the commercialization of SDA soy bean oil prior to obtaining all relevant regulatory a pprovals will be utilized through the initial product introduction phase until all relevant global approvals in key s oy b ean export countries with functioning regulatory

s ys tems are received. M onsanto will refine and update the stewardship sy stem for long - term implementation based upon the experience and learning developed during the CL SS production phase and through continued dialogue with stakeholders. This dialog will aid in the assessment and development processes while enabling transparent communication regarding policy

i mplementation. The long - term stewardship plan for MON 87769 derived through these actions will be designed to ensure that the SDA soy bean oil is directed to its intended specialty market. **Summary** SDA soy bean offers U.S. soy

bean growers the opportunity to supply av alue added and sustainable omega - 3 alternative that will provide food industry w ith choic es to satisfy

agrowing omega - 3 market. T he closed loop stewardship sy stem for the production and handling of MON 87769 and derived products is designed to ensure that SDA soy bean and oil will be isolated from commodity s oy bean and oil as well as other ve getable oils in the market place and are directed to their intended specialty uses. The market and trade assessment has concluded that in the unlikely

e vent comingling did occur, the impact to labeling and functionality w ould be181

minimal. B ecause SDA soy b ean is generally

recognized as safe in the United States 22 and the defatted meal from SDA soy bean is similar to commodity s oy bean meal, there would be no negative impact to human heath from the use of any o f the other processed fractions produced from soy be an due to comingling of SDA soybean with commodity s oy bean. G iven the abundance of vegetable oils on the market and demonstrated ability o f the sy stem to adapt to consumer preferences incorporating new oils into existing food manufacturing processes, the introduction of SDA soy

bean is expected to be easily m anaged by

e xisting industry

m echanisms and identity

preservation sy stems. Monsanto continues to engage stakeholders and educate them on the benefits of SDA soy beans and proper stewardship practices.

22 http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASListings/ucm185688.htm182

**References** James, M.J., V.M. Ursin, and L .G. Cleland. 2003. Metabolism of stearidonic acid in human subjects: comparison with the metabolism of other n - 3 fatty acids. American Journal of Clinical Nutrition 77:1140 - 1145. Lemke, S.L ., Vicini, J.L ., Su, H., Goldstein, D.A., Nemeth, M.A., Krul, E.A., and Harris, W.S. 2010. Dietary

i ntake of stearidonic acid

–enriched soy

bean oil increases the omega - 3 index: randomized, double - blind clinical study of efficacy

and safety . Am J Clin Nutr 92:766

–75. NOPA. 2006. Trading Rules for the Purchase and Sale of Soy bean Meal. National Oilseed Processors Association, Washington, D.C. Orthoefer, F. T. and List, G. R. 2007. Evaluation of Used Frying Oil in Deep Frying: Chemistry , Nutrition and Practical Applications, 2 nd Edi tion. Erickson, M.D. Editor. p 329 - 342. King, S. et al. 2002. The sensory quality s ys tem: a global quality control solution. Food Quality and Preference (13) 385 - 395.183

**12 LIST OF PREPARERS**  David Reinhold, Ass istant Director, APHIS - BRS - Enviro nmental Risk Assessment Program Craig Roseland , Ph.D. , APHI S - BRS - Senior Environmental Protection Specialist Diane Sinkowski, APHIS - BRS - Environmental Protection Specialist Khamkeo Vongpaseuth , Ph.D. APHI S - BRS - Environmental Protection Specialist