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19-099- 01P) for a Determination of Nonregulated Status for Petunias Containing the A1 Gene of Maize (A1-DFR Petunias)

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19-099- 01P) for a Determination of Nonregulated Status for Petunias Containing the A1 Gene of Maize (A1-DFR Petunias) Westhoff Vertriebsgesellschaft mbH Petition (19-099- 01p) for a Determination of Nonregulated Status for Petunias Containing the A1 Gene of Maize (A1-DFR petunias) Draft Environmental Assessment February 2020 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. TABLE OF CONTENTS 1 PURPOSE AND NEED ............................................................................................................................... 1-1 1.1 WESTHOFF VERTRIEBSGESELLSCHAFT MBH PETITION FOR NONREGULATED STATUS ....................................................1-1 1.2 PURPOSE OF A1-DFR PETUNIAS .......................................................................................................................1-1 1.3 THE COORDINATED FRAMEWORK AND REGULATION OF BIOTECHNOLOGY PRODUCTS ..................................................1-2 1.3.1 USDA-APHIS ..........................................................................................................................................1-2 1.3.2 Environmental Protection Agency ........................................................................................................1-2 1.3.3 Food and Drug Administration .............................................................................................................1-3 1.4 PURPOSE AND NEED FOR APHIS ACTION ...........................................................................................................1-4 1.5 PUBLIC INVOLVEMENT ....................................................................................................................................1-4 1.5.1 Public Involvement for Petition 19-099-01p .........................................................................................1-4 1.5.2 Issues Considered in the EA ...................................................................................................................1-5 2 ALTERNATIVES ........................................................................................................................................ 2-6 2.1 NO ACTION ALTERNATIVE: DENY THE PETITION AND CONTINUATION AS A REGULATED ARTICLE ....................................2-6 2.2 PREFERRED ALTERNATIVE: APPROVAL OF THE PETITION FOR NONREGULATED STATUS .................................................2-6 2.3 ALTERNATIVES CONSIDERED BUT DISMISSED FROM DETAILED ANALYSIS ....................................................................2-6 2.4 COMPARISON OF THE ALTERNATIVES..................................................................................................................2-7 3 AFFECTED ENVIRONMENT ....................................................................................................................... 3-1 3.1 PETUNIA BREEDING AND PRODUCTION ...............................................................................................................3-1 3.1.1 Commercial Growing Practices .............................................................................................................3-2 3.1.2 U.S. Petunia Production ........................................................................................................................3-3 3.1.3 Pest and Pathogen Management .........................................................................................................3-6 3.2 PHYSICAL ENVIRONMENT .................................................................................................................................3-8 3.2.1 Soils .......................................................................................................................................................3-8 3.2.2 Water Resources ...................................................................................................................................3-9 3.2.3 Air Quality ...........................................................................................................................................3-11 3.3 BIOLOGICAL ENVIRONMENT ...........................................................................................................................3-11 3.3.1 Soil Biota .............................................................................................................................................3-11 3.3.2 Animal Communities ...........................................................................................................................3-12 3.3.3 Plant Communities ..............................................................................................................................3-12 3.3.4 Gene Flow and Weediness ..................................................................................................................3-16 3.3.5 Biodiversity .........................................................................................................................................3-18 3.4 HUMAN HEALTH ..........................................................................................................................................3-19 3.4.1 Consumer Health ................................................................................................................................3-19 3.4.2 Worker Safety .....................................................................................................................................3-20 3.5 SOCIOECONOMICS ........................................................................................................................................3-21 3.5.1 Domestic Economic Environment .......................................................................................................3-21 3.5.1.1 GE Ornamentals ......................................................................................................................................... 3-21 3.5.1.2 GE Petunia – Market Impacts ..................................................................................................................... 3-21 3.5.2 International Trade .............................................................................................................................3-23 4 ENVIRONMENTAL CONSEQUENCES ......................................................................................................... 4-1 4.1 COMMERCIAL PETUNIA PRODUCTION ................................................................................................................4-1 i 4.2 PHYSICAL ENVIRONMENT .................................................................................................................................4-2 4.2.1 Soil Quality ............................................................................................................................................4-2 4.2.2 Water Resources ...................................................................................................................................4-2 4.2.3 Air Quality .............................................................................................................................................4-3 4.3 BIOLOGICAL RESOURCES ..................................................................................................................................4-3 4.3.1 Soil Biota ...............................................................................................................................................4-3 4.3.2 Animal Communities .............................................................................................................................4-4 4.3.3 Plant Communities ................................................................................................................................4-6 4.3.4 Gene Flow and Weediness ....................................................................................................................4-6 4.3.5 Biodiversity .........................................................................................................................................4-10 4.4 HUMAN HEALTH AND WORKER SAFETY ............................................................................................................4-10 4.5 SOCIOECONOMICS ........................................................................................................................................4-11
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