Nuseed DHA Canola Final EA
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Nuseed Americas Inc. Petition (17-236-01p) for Nonregulated Status for DHA Canola (Brassica napus) OECD Unique Identifier: NS-B5ØØ27-4 Final Environmental Assessment August 2018 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 BACKGROUND .................................................................................................................................................. 1 1.2 PURPOSE OF DHA CANOLA ................................................................................................................................. 1 1.3 THE COORDINATED FRAMEWORK FOR THE REGULATION OF BIOTECHNOLOGY ............................................................... 2 1.3.1 USDA-APHIS ............................................................................................................................................. 2 1.3.2 Environmental Protection Agency ........................................................................................................... 2 1.3.3 Food and Drug Administration ................................................................................................................ 3 1.4 PURPOSE AND NEED FOR APHIS ACTION .............................................................................................................. 4 1.5 PUBLIC INVOLVEMENT ....................................................................................................................................... 4 1.5.1 First Opportunity for Public Involvement ................................................................................................. 4 1.5.2 Second Opportunity for Public Involvement ............................................................................................ 4 1.5.3 Public Involvement for Petition 17-236-01p ............................................................................................ 5 1.5.4 Issues Considered in this EA ..................................................................................................................... 6 2 ALTERNATIVES ........................................................................................................................................... 8 2.1 NO ACTION ALTERNATIVE: CONTINUATION AS A REGULATED ARTICLE ......................................................................... 8 2.2 PREFERRED ALTERNATIVE: DETERMINATION OF NONREGULATED STATUS FOR DHA CANOLA ........................................... 8 2.3 ALTERNATIVES CONSIDERED BUT DISMISSED FROM DETAILED ANALYSIS ....................................................................... 8 2.3.1 Prohibit the Release of DHA Canola ......................................................................................................... 8 2.3.2 Approve the Request in Part .................................................................................................................... 9 2.3.3 Isolation of DHA Canola and Non-GE Canola Production Systems or Geographic Restriction................. 9 2.3.4 Requirements to Test for DHA Canola ................................................................................................... 10 2.4 COMPARISON OF THE ALTERNATIVES CONSIDERED ................................................................................................. 10 3 AFFECTED ENVIRONMENT ........................................................................................................................ 16 3.1 OVERVIEW OF CANOLA PRODUCTION AND USES ................................................................................................... 16 3.1.1 Rapeseed and Canola Cultivars.............................................................................................................. 16 3.1.2 Canola .................................................................................................................................................... 17 3.1.2.1 Canola Oil ...................................................................................................................................................... 18 3.1.2.2 Canola Meal .................................................................................................................................................. 18 3.2 ACREAGE AND AREAS OF CANOLA PRODUCTION.................................................................................................... 19 3.2.1 Global Production .................................................................................................................................. 19 3.2.2 U.S. Production: Conventional, GE, and Organic Canola ....................................................................... 20 3.2.2.1 Conventional Canola ..................................................................................................................................... 22 3.2.2.2 GE Canola in the United States ..................................................................................................................... 22 3.2.2.3 Organic Canola Production ........................................................................................................................... 23 3.3 AGRONOMIC PRACTICES AND INPUTS .................................................................................................................. 23 3.3.1 Tillage .................................................................................................................................................... 24 3.3.2 Agronomic Inputs ................................................................................................................................... 24 3.3.2.1 Fertilizers ....................................................................................................................................................... 24 3.3.2.2 Pesticides: Insecticides and Fungicides ......................................................................................................... 25 3.3.2.3 Pesticides: Herbicides ................................................................................................................................... 26 3.3.3 Pest and Pathogen Resistance Management ........................................................................................ 29 3.3.4 Volunteer Management ........................................................................................................................ 30 3.3.5 Pesticide Toxicity .................................................................................................................................... 31 i 3.4 PHYSICAL ENVIRONMENT .................................................................................................................................. 31 3.4.1 Soils ........................................................................................................................................................ 31 3.4.2 Water Resources .................................................................................................................................... 33 3.4.3 Air Quality .............................................................................................................................................. 34 3.5 BIOLOGICAL RESOURCES ................................................................................................................................... 35 3.5.1 Soil Biota ................................................................................................................................................ 35 3.5.2 Animal and Plant Communities ............................................................................................................. 35 3.5.2.1 Animals.......................................................................................................................................................... 35 3.5.2.2 Vegetation Associated with Canola Fields....................................................................................................