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19-176-01P) for the Determination of Nonregulated Status for Maize Event PY203: Zea Mays Expressing a Phytase Gene Derived from Escherichia Coli Strain K12

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19-176-01P) for the Determination of Nonregulated Status for Maize Event PY203: Zea Mays Expressing a Phytase Gene Derived from Escherichia Coli Strain K12 United States Department of Agriculture Agrivida, Inc. Petition (19-176-01p) for the Determination of Nonregulated Status for Maize Event PY203: Zea mays Expressing a Phytase Gene Derived from Escherichia coli Strain K12 OECD Unique Identifier: AGV-PY203-4 Draft Environmental Assessment April 2021 Agency Contact Cindy Eck Biotechnology Regulatory Services 4700 River Road USDA, APHIS Riverdale, MD 20737 In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident. Persons with disabilities who require alternative means of communication for program information (e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English. To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at How to File a Program Discrimination Complaint and at any USDA office or write a letter addressed to USDA and provide in the letter all of the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by: (1) mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue, SW, Washington, D.C. 20250-9410; (2) fax: (202) 690-7442; or (3) email: [email protected]. Mention of companies or commercial products in this report does not imply recommendation or endorsement by the U.S. Department of Agriculture (USDA) 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. TABLE OF CONTENTS Page 1 PURPOSE AND NEED FOR AGENCY ACTION .............................................................................................. 1-1 1.1 BACKGROUND ...............................................................................................................................................1-1 1.2 PURPOSE OF PY203 CORN ..............................................................................................................................1-1 1.3 COORDINATED FRAMEWORK FOR THE REGULATION OF BIOTECHNOLOGY ..................................................................1-3 1.4 REQUIREMENT TO ISSUE A REGULATORY STATUS DETERMINATION ..........................................................................1-4 2 SCOPING AND PUBLIC INVOLVEMENT ...................................................................................................... 1-4 2.1 PUBLIC INVOLVEMENT FOR PETITION 19-176-01P ..............................................................................................2-5 2.2 ISSUES CONSIDERED IN THIS EA ........................................................................................................................2-5 3 ALTERNATIVES ........................................................................................................................................ 3-1 3.1 NO ACTION ALTERNATIVE: DENY THE PETITION REQUEST ......................................................................................3-1 3.2 PREFERRED ALTERNATIVE: APPROVE THE PETITION–DETERMINATION OF NONREGULATED STATUS FOR PY203 CORN ......3-1 3.3 ALTERNATIVES CONSIDERED BUT DISMISSED FROM DETAILED ANALYSIS IN THE EA .....................................................3-1 3.4 SUMMARY OF THE NO ACTION AND PREFERRED ALTERNATIVE ANALYSES ..................................................................3-2 4 AFFECTED ENVIRONMENT AND ENVIRONMENTAL CONSEQUENCES ......................................................... 4-1 4.1 SCOPE OF ANALYSIS ........................................................................................................................................4-1 4.2 NO ACTION ALTERNATIVE – DENY THE PETITION ..................................................................................................4-3 4.3 PREFERRED ALTERNATIVE – APPROVE THE PETITION .............................................................................................4-4 4.3.1 U.S. Corn Production .............................................................................................................................4-4 4.3.2 Physical Environment ..........................................................................................................................4-12 4.3.3 Biological Resources ...........................................................................................................................4-30 4.3.4 Human Health .....................................................................................................................................4-45 4.3.5 Livestock Health and Welfare .............................................................................................................4-50 4.3.6 Socioeconomics ...................................................................................................................................4-52 4.3.7 Compliance with Federal and State Laws and Regulations, Executive Orders, Policies, and Treaties 4-57 4.3.8 Conclusions: Potential Impacts on the Human Environment ..............................................................4-60 APPENDIX 1: THREATENED AND ENDANGERED SPECIES ................................................................................. A1-1 APPENDIX 2: LIST OF PREPARERS ................................................................................................................... A2-1 APPENDIX 3: REFERENCES .............................................................................................................................. A3-1 i LIST OF TABLES Table 3-1. Summary of Potential Impacts of the Alternatives Considered .............................................. 3-2 Table 4-1. Top Practices in Pest Management, 2018 Crop Year .............................................................. 4-7 Table 4-2. Fertilizer Applied to Corn Planted Acres, 2018 Crop Year ....................................................... 4-9 Table 4-3. Tillage Practice on U.S. Cropland, 2012 – 2017 ..................................................................... 4-14 Table 4-4. Causes of Impairment in Assessed Waters, 2019 .................................................................. 4-16 Table 4-5. Estimated Nitrogen (N) and Phosphorus (P) Produced from Animal Manure in 2007 ......... 4-20 Table 4-6. PY203 Corn Phytate and Phosphorus Composition ............................................................... 4-23 Table 4-7. Livestock and Manure Production and Use in the United States, 2017 ................................ 4-23 Table 4-8. Animals Commonly Found in Corn Fields .............................................................................. 4-33 LIST OF FIGURES Figure 1-1. Phytate and Inorganic Phosphorus ........................................................................................ 1-2 Figure 4-1. Corn Uses in the United States, 2019 ..................................................................................... 4-5 Figure 4-2. Corn Cultivation in the United States by County, 2019.......................................................... 4-6 Figure 4-3. Biotech Corn Traits Planted in the United States, 2019 ......................................................... 4-7 Figure 4-4. Conservation Tillage Practices in Corn, 2005 – 2016 ............................................................. 4-9 Figure 4-5. Pesticides Applied to Corn, 2018 .......................................................................................... 4-11 Figure 4-6. Locations and Status of U.S. Croplands Subject to Water and Wind Erosion ...................... 4-13 Figure 4-7. Areas of Impaired Rivers and Streams in the United States ................................................ 4-17 Figure 4-8. Agricultural Runoff: Mississippi River Watershed ................................................................ 4-18 Figure 4-9. Gulf of Mexico Dead Zone, 2019 .......................................................................................... 4-19 Figure 4-10. Cropland and Pastureland Treated with Manure in the United States, 2012 .................... 4-25 ii ACRONYMS AND ABBREVIATIONS AOSCA Association of Official Seed Certifying Agencies APHIS Animal and Plant Health Inspection Service CAA Clean Air Act CEQ Council on Environmental Quality CFR Code of Federal Regulations (United States) CO carbon monoxide CO2 carbon dioxide CWA Clean Water Act DNA deoxyribonucleic acid EA Environmental Assessment EO Executive Order EPA U.S. Environmental Protection Agency ESA Endangered
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