Monsanto Petitions (10-188-01p and 12-185-01p) for Determinations of Nonregulated Status for Dicamba- Resistant Soybean and Cotton Varieties Final Environmental Impact Statement December 2014 Agency Contact: Sid Abel Biotechnology Regulatory Services 4700 River Road USDA, APHIS Riverdale, MD 20737 Fax: (301) 734-6352 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. CAUTION: Pesticides can be injurious to humans, domestic animals, desirable plants, and fish and other wildlife—if they are not handled or applied properly. Use all pesticides selectively and carefully. Follow recommended label practices Executive Summary The U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) received two requests (petitions) from Monsanto Company, St. Louis, MO (Monsanto) seeking determinations of nonregulated status for genetically engineered (GE) plant varieties referred to as MON 87708 soybean and MON 88701 cotton, that have been engineered to be resistant to the herbicide dicamba (Monsanto, 2012b; 2012a). These GE plant varieties are currently regulated by APHIS, and Monsanto requests that APHIS grant the petitions (Petition 10-188-01p for MON 87708 soybean and Petition 12-185-01p for MON 88701 cotton), so that these varieties can be grown without any APHIS regulatory oversight. Since these two GE plant varieties are currently under APHIS regulatory oversight, the Agency requires Monsanto to comply with a full range of safeguarding measures to ensure that these regulated GE plant varieties do not transfer or spread from their APHIS-approved outdoor planting sites. APHIS authorization is also required to move these regulated varieties interstate. Once a developer of a GE plant has obtained sufficient information to conclude that its regulated GE plant is unlikely to cause injury, damage, or disease to plants or plant products (i.e., pose a plant pest risk), it may submit a petition to APHIS to no longer regulate the organism. This is referred to as seeking nonregulated status. If a petition for nonregulated status is approved by APHIS, permits or notifications are no longer required by the Agency to grow or ship the GE plant throughout the United States and its territories. If APHIS determines that nonregulated status is appropriate for one or both the Monsanto GE varieties, they will no longer be subject to any regulations pursuant to Part 340. Regulatory Authority APHIS regulates certain GE organisms under the authority of the PPA of 2000 as amended (7 U.S.C. §§ 7701–7772), and by APHIS regulations codified in Title 7, part 340 of the U.S. Code of Federal Regulations (7 CFR part 340). The APHIS part 340 regulations govern a GE organism in the following circumstances: if it is a plant pest (such as certain microorganisms or insects that can cause injury or damage to plants); if it is created using an organism that is itself a plant pest; if APHIS does not have sufficient information to determine if the GE organism is or may be a plant pest. Any party can petition APHIS for “nonregulated status” of a GE organism (that is, to discontinue regulating a GE organism that falls under its regulations) through the procedures described in 7 CFR § 340.6. APHIS regulates such a GE organism until a request for nonregulated status is made. The agency then evaluates whether it meets the PPA definition of a plant pest, and it concludes on the basis of scientific evidence that the GE organism is unlikely to pose a plant pest risk by determining that the potential for the GE organism to cause plant disease or damage is unlikely. The petitioner must provide data, including information obtained from confined field tests regulated by APHIS, to help inform Agency decisionmakers. APHIS analyzes the data from the petitioner, researches current scientific findings, and prepares a Plant Pest Risk Assessment (PPRA) that documents whether or not the GE organism is likely to cause disease or damage. If APHIS concludes that the GE organism does not pose plant pest risk, APHIS must then issue a i regulatory decision of non-regulated status, since the Agency does not have regulatory authority to regulate organisms that are not plant pests. When a determination of nonregulated status has been issued, the GE organism may be introduced into the environment without APHIS regulatory oversight under Part 340. In the case of the GE soybean and cotton varieties that are the subject of this environmental impact statement (EIS), if nonregulated status is determined to be appropriate for them, Monsanto will be allowed to sell the GE seeds to farmers, and growers will be able to grow, harvest, and move their crop into commerce for food and feed without any authorization from APHIS. Two other agencies, the Federal Drug Administration (FDA) and the Environmental Protection Agency (EPA), provide oversight of GE plants. The relative roles of the USDA (through APHIS), the FDA, and the EPA are described by the “Coordinated Framework,” a 1986 policy statement from the Office of Science and Technology Policy that describes the comprehensive Federal policy for ensuring the safety of biotechnology research and products (US-OSTP, 1986). The FDA’s regulation of GE plants is based upon its authority to regulate food safety under the Federal Food, Drug, and Cosmetic Act (FFDCA) 21 U.S.C. §§ 301 – 399. The FDA implements a voluntary consultation process to ensure that human food and animal feed safety issues or other regulatory issues, such as labeling, are resolved before commercial distribution of food derived from GE products. The EPA regulates the use, sale, and labeling of pesticides pursuant to its authority under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. §§ 136–136y). EPA’s actions under FIFRA directly affect the production methods used on herbicide-resistant (HR) GE plants. An herbicide must first be “registered” by the EPA before it can be distributed or sold in the U.S. (7 U.S.C. §§ 136a(a),136j(a)(2)(F)). The EPA registration process starts with the herbicide manufacturer providing the EPA with information about the herbicide (7 U.S.C. § 136a(c)(1)(C), (F)). The agency then evaluates the adverse effects it may have on humans and the environment in accordance with the proposed label. On the basis of this evaluation, the EPA then determines if it will allow use of the herbicide on a plant, and, if so, under what conditions and in what quantity. The EPA sets the conditions for herbicide use and places them in labeling instructions that a user must follow (See 7 U.S.C. 136j(a)(2)(G)). The EPA reevaluates all pesticides, which includes herbicides, every fifteen years (or shorter) to ensure they meet current standards for continued safe use (7 U.S.C.§ 136a(g)(1)(A)(iv)). Under FIFRA, the EPA also regulates plant-incorporated protectants (PIPs) which are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. The varieties that are the subject of this EIS, MON 87708 soybean and MON 88701 cotton, are both resistant to the herbicide dicamba. MON 88701 cotton is also resistant to the herbicide glufosinate. The EPA is currently reviewing proposed changes in the registered uses of dicamba on these soybean and cotton varieties. If approved by the EPA, these label changes will allow for the direct application of dicamba to MON 87708 soybean and MON 88701 cotton. Following the ii EPA’s approval, dicamba herbicide products that could be used on MON 87708 soybean and MON 88701 cotton could include lower volatility dicamba formulations based on the diglycolamine (DGA) salt, as well as those based on the BAPMA1 salt. These proposed label changes were requested by Monsanto based on the standard that the new uses of this herbicide would not cause any unreasonable adverse environmental effects and a reasonable certainty of no harm to humans, so long as it was applied in accordance with its labeling instructions. Monsanto is not requesting any changes to the current EPA-approved uses for glufosinate for MON 88701 cotton; thus, no new review of the label by the EPA is required. The EPA does not regulate MON 87708 soybean and MON 88701 cotton plants because these plants are not plant incorporated protectants. Purpose of MON 87708 Soybean and MON 88701 Cotton Monsanto has developed these two GE plant varieties as alternatives to currently available GE herbicide-resistant (HR) soybean and cotton varieties (Monsanto, 2012a; 2012b). The primary purpose of MON 87708 soybean and MON 88701 cotton is to provide growers with additional and enhanced pre-emergence and in-crop weed management options in soybean and cotton cultivation to control a broad spectrum of broadleaf weeds, including glyphosate-resistant (GR) broadleaf weed species.