Syngenta Company Petition for Determination of Nonregulated Status of SYN-05307-1 Rootworm Resistant Corn
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Syngenta Company Petition for Determination of Nonregulated Status of SYN-05307-1 Rootworm Resistant Corn OECD Unique Identifier: SYN-Ø53Ø7-1 Draft Environmental Assessment May 2012 Agency Contact Cindy Eck Biotechnology Regulatory Services 4700 River Road USDA, APHIS Riverdale, MD 20737 Fax: (301) 734-8669 The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, sex, religion, age, disability, political beliefs, sexual orientation, or marital or family status. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact USDA’S TARGET Center at (202) 720–2600 (voice and TDD). To file a complaint of discrimination, write USDA, Director, Office of Civil Rights, Room 326–W, Whitten Building, 1400 Independence Avenue, SW, Washington, DC 20250–9410 or call (202) 720–5964 (voice and TDD). USDA is an equal opportunity provider and employer. Mention of companies or commercial products in this report does not imply recommendation or endorsement by the U.S. Department of Agriculture over others not mentioned. USDA neither guarantees nor warrants the standard of any product mentioned. Product names are mentioned solely to report factually on available data and to provide specific information. This publication reports research involving pesticides. All uses of pesticides must be registered by appropriate State and/or Federal agencies before they can be recommended. i TABLE OF CONTENTS PAGE ACRONYMS AND ABBREVIATIONS ........................................................................... II 1 PURPOSE AND NEED .............................................................................................. 1 1.1 Regulatory Authority............................................................................................ 1 1.2 Regulated Organisms ........................................................................................... 2 1.3 Petition for Determination of Nonregulated Status: Syngenta Event 5307 Corn 2 1.4 Purpose of Product ............................................................................................... 3 1.5 APHIS Response to Petition for Nonregulated Status ......................................... 3 1.6 Coordinated Framework Review ......................................................................... 4 1.6.1 Environmental Protection Agency ................................................................ 4 1.6.2 Food and Drug Administration ..................................................................... 5 1.7 Public Involvement .............................................................................................. 5 1.8 Issues Considered ................................................................................................. 5 2 AFFECTED ENVIRONMENT .................................................................................. 7 2.1 Corn Biology ........................................................................................................ 7 2.1.1 Persistence in the Environment/Weediness Potential ................................... 9 2.2 Corn Production ................................................................................................... 9 2.2.1 Production and Yield .................................................................................... 9 2.2.2 Agronomic Practices ................................................................................... 12 2.2.3 Specialty Corn Systems .............................................................................. 25 2.2.4 Raw and Processed Corn Commodities ...................................................... 28 2.3 Physical Environment ........................................................................................ 28 2.3.1 Water Quality and Use ................................................................................ 28 2.3.2 Soil .............................................................................................................. 30 2.3.3 Air Quality .................................................................................................. 30 2.3.4 Climate ........................................................................................................ 30 2.4 Biological Environment ..................................................................................... 31 2.4.1 Animals ....................................................................................................... 31 2.4.2 Plants ........................................................................................................... 32 2.4.3 Soil Microorganisms ................................................................................... 32 2.4.4 Biodiversity ................................................................................................. 33 2.4.5 Gene Movement in the Natural Environment ............................................. 33 2.5 Public Health ...................................................................................................... 33 2.5.1 Human Health ............................................................................................. 34 2.5.2 Animal (Livestock) Health ......................................................................... 35 2.5.3 Worker Safety ............................................................................................. 36 2.6 Socioeconomic ................................................................................................... 36 2.6.1 Domestic Economic Environment .............................................................. 36 2.6.2 Trade Economic Environment .................................................................... 38 2.6.3 Social Environment ..................................................................................... 38 i TABLE OF CONTENTS PAGE 3 ALTERNATIVES..................................................................................................... 40 3.1 No Action Alternative: Continuation as a Regulated Article ............................ 40 3.2 Proposed Action: Determination That Event 5307 Corn Is No Longer a Regulated Article ................................................................................................................ 40 3.3 Alternatives Considered But Rejected from Further Consideration .................. 40 3.3.1 Prohibit Any Event 5307 Corn from Being Released ................................. 41 3.3.2 Approve the Petition in Part ........................................................................ 41 3.3.3 Isolation Distance between Event 5307 Corn and Non-GE Corn Production and Geographical Restrictions .................................................................... 41 3.3.4 Requirement of Testing for Event 5307 Corn............................................. 42 3.4 Comparison of Alternatives ............................................................................... 42 4 ENVIRONMENTAL CONSEQUENCES ............................................................... 44 4.1 Scope of Environmental Analysis ...................................................................... 44 4.1.1 Persistence in the Environment/Weediness Potential ................................. 45 4.2 Corn Production ................................................................................................. 45 4.2.1 Production and Yield .................................................................................. 45 4.2.2 Agronomic Practices ................................................................................... 46 4.2.3 Specialty Corn Systems .............................................................................. 52 4.2.4 Raw and Processed Corn Commodities ...................................................... 57 4.3 Physical Environment ........................................................................................ 57 4.3.1 Water Quality and Use ............................................................................... 57 4.3.2 Soil .............................................................................................................. 59 4.3.3 Air Quality .................................................................................................. 60 4.3.4 Climate ........................................................................................................ 60 4.4 Biological Environment ..................................................................................... 61 4.4.1 Animals ....................................................................................................... 62 4.4.2 Plants ........................................................................................................... 68 4.4.3 Soil Microorganisms ................................................................................... 68 4.4.4 Biodiversity ................................................................................................. 70 4.4.5 Gene Movement in the Natural Environment ............................................. 71 4.5 Public Health ...................................................................................................... 72 4.5.1 Human Health ............................................................................................. 72 4.5.2 Animal (Livestock) Health ........................................................................