Monsanto Petition (09-SY-2000U) for Determination of Non-regulated Status of (MON 87769) Stearidonic Acid Soybean OECD Unique Identifier: MON 87769-7 Draft Environmental Assessment October 2011 Agency Contact Cindy Eck Biotechnology Regulatory Services 4700 River Road USDA, APHIS Riverdale, MD 20737 Fax: (301) 734-8669 The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, sex, religion, age, disability, political beliefs, sexual orientation, or marital or family status. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact USDA’S TARGET Center at (202) 720–2600 (voice and TDD). 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All uses of pesticides must be registered by appropriate State and/or Federal agencies before they can be recommended. i ii TABLE OF CONTENTS PAGE 1 PURPOSE AND NEED .............................................................................................. 1 1.1 Regulatory Authority............................................................................................ 1 1.2 Regulated Organisms ........................................................................................... 2 1.3 Petition for Determination of Nonregulated Status: MON 87769 Soybean ......... 2 1.4 Purpose of Product ............................................................................................... 3 1.5 APHIS Response to Petition for Nonregulated Status ......................................... 5 1.6 Coordinated Framework Review ......................................................................... 6 1.6.1 U.S. Environmental Protection Agency ........................................................ 6 1.6.2 Food and Drug Administration ..................................................................... 6 1.7 Public Involvement .............................................................................................. 7 1.8 Issues Considered ................................................................................................. 7 2 AFFECTED ENVIRONMENT .................................................................................. 9 2.1 Soybean Products and Composition ..................................................................... 9 2.1.1 Soybean Use.................................................................................................. 9 2.1.2 Soybean Composition ................................................................................. 12 2.2 Agricultural Production of Soybean ................................................................... 13 2.2.1 Acreage and Area of Soybean Production .................................................. 14 2.2.2 Agronomic Practices ................................................................................... 16 2.2.3 Soybean Seed Production ........................................................................... 23 2.2.4 Organic Soybean Production ...................................................................... 24 2.2.5 Specialty Soybean Production .................................................................. 26 2.3 Physical Environment ........................................................................................ 30 2.3.1 Water Resources ......................................................................................... 30 2.3.2 Soil Quality ................................................................................................. 33 2.3.3 Air Quality .................................................................................................. 35 2.3.4 Climate Change ........................................................................................... 38 2.4 Biological Resources .......................................................................................... 40 2.4.1 Animal Communities .................................................................................. 40 2.4.2 Plant Communities ...................................................................................... 41 2.4.3 Gene Flow and Weediness .......................................................................... 42 2.4.4 Microorganisms .......................................................................................... 45 2.4.5 Biodiversity ................................................................................................. 46 2.5 Human Health .................................................................................................... 49 2.5.1 Public Health ............................................................................................... 49 2.5.2 Human Dietary Health ................................................................................ 50 2.5.3 Worker Safety ............................................................................................. 53 2.6 Animal Feed ....................................................................................................... 53 2.7 Socioeconomic ................................................................................................... 54 2.7.1 Domestic Economic Environment .............................................................. 54 i TABLE OF CONTENTS PAGE 2.7.2 Trade Economic Environment .................................................................... 59 2.7.3 Social Environment ..................................................................................... 60 3 ALTERNATIVES..................................................................................................... 62 3.1 No Action Alternative: Continuation as a Regulated Article ............................ 62 3.2 Preferred Alternative: Determination that MON 87769 Soybean is No Longer a Regulated Article ............................................................................................... 62 3.3 Alternatives Considered But Rejected from Further Consideration .................. 63 3.3.1 Prohibit Any MON 87769 Soybean from Being Released ......................... 63 3.3.2 Approve the Petition in Part ........................................................................ 64 3.3.3 Isolation Distance between MON 87769 Soybean and Non-GE Soybean Production and Geographical Restrictions ................................................. 64 3.3.4 Requirement of Testing for MON 87769 Soybean ..................................... 65 3.4 Comparison of Alternatives ............................................................................... 65 4 ENVIRONMENTAL CONSEQUENCES ............................................................... 67 4.1 Scope of Analysis ............................................................................................... 67 4.2 Agricultural Production of Soybean ................................................................... 68 4.2.1 Acreage and Area of Soybean Production .................................................. 68 4.2.2 Agronomic Practices ................................................................................... 70 4.2.3 Soybean Seed Production ........................................................................... 72 4.2.4 Organic Soybean Production ...................................................................... 72 4.2.5 Specialty Soybean Production .................................................................... 74 4.3 Physical Environment ........................................................................................ 75 4.3.1 Water Resources ......................................................................................... 75 4.3.2 Soil Quality ................................................................................................. 76 4.3.3 Air Quality .................................................................................................. 77 4.3.4 Climate Change ........................................................................................... 77 4.4 Biological Resources .......................................................................................... 78 4.4.1 Animal Communities .................................................................................. 78 4.4.2 Plant Communities ...................................................................................... 80 4.4.3 Gene Flow and Weediness .......................................................................... 81 4.4.4 Microorganisms .......................................................................................... 84 4.4.5 Biodiversity ................................................................................................. 85 4.5 Human Health ...................................................................................................