Dow AgroSciences Petitions (09-233- 01p, 09-349-01p, and 11-234-01p) for Determinations of Nonregulated Status for 2,4-D-Resistant Corn and Soybean Varieties Draft Environmental Impact Statement—2013 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 three requests (petitions) from Dow AgroSciences (DAS) seeking determinations of nonregulated status for genetically engineered (GE) plant varieties referred to as: DAS-40278-9 corn, DAS-68416-4 soybean, and DAS-44406-6 soybean (also known as Enlist™ corn and soybean). Currently these GE plant varieties are regulated by APHIS, and DAS needs authorization from APHIS to grow these varieties without any APHIS regulatory oversight. Since these three GE plant varieties are currently under APHIS’ regulatory oversight, APHIS requires that DAS complies with a full range of safeguarding measures to ensure that these regulated GE plant varieties do not transfer or spread from their outdoor plantings until these varieties are removed from regulation. APHIS authorization is also required to move these regulated varieties interstate. Once a developer of a GE plant has obtained enough information to conclude that their regulated GE plant is unlikely to cause injury, damage, or disease to plants or plant products (that is, pose a plant pest risk), they may petition APHIS to no longer regulate their GE plant. Usually the petition is received when the developer wishes to commercialize a specific GE plant variety. This petition is referred to as seeking “nonregulated status” or as requesting a “deregulation.” If the petition for nonregulated status is approved by APHIS, then APHIS’ permits would no longer be required to grow or ship the genetically engineered plant throughout the US and its territories. This scenario would be the case, as applicable to the three GE plant varieties, if APHIS determines that nonregulated status is appropriate for one or more of the three DAS GE varieties. Regulatory Authority APHIS regulates certain genetically engineered organisms by authority provided in the Plant Protection Act (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). 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); or, if it is created using an organism that is itself a plant pest; or, if APHIS does not know or cannot 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 C.F.R § 340.6. APHIS regulates such a GE organism until the agency evaluates whether the GE organism meets the PPA definition of a plant pest and concludes on the basis of scientific evidence that the GE organism is unlikely to pose a plant pest risk; that is to say that the potential for the GE organism to cause plant disease or damage is unlikely. The petitioner must provide data, usually and in this case as well, gathered through confined field tests regulated by APHIS, to help inform the agency’s decision. APHIS analyzes the data from the petitioner, researches current scientific findings, and prepares a Plant Pest Risk Assessment (PPRA) that documents i whether or not the GE organism is likely to cause disease or damage. If APHIS concludes that the GE organism does not pose any plant pest risk, APHIS must then issue a regulatory decision of non-regulated status since the agency does not have regulatory authority to regulate organisms that are not plant pests. When a decision of nonregulated status has been issued, the GE organism may be introduced into the environment without APHIS’ regulatory oversight. In the case of the GE corn and soybean that are the subject of this draft EIS, if nonregulated status is determined to be appropriate for them, DAS will be able to market the GE seeds to farmers for planting, and farmers will be able to grow, harvest, and move their crop into commerce for food and feed without any further authorization from APHIS. Two other agencies, the Federal Drug Administration (FDA) and the Environmental Protection Agency (EPA), provide oversight of genetically engineered plants. The relative roles of the USDA (through APHIS), FDA, and EPA are described by the “Coordinated Framework”, a 1986 policy statement from the Office of Science and Technology Policy that describes the comprehensive policy for ensuring the safety of biotechnology research and products (US-OSTP, 1986). The FDA’s regulation of genetically modified 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 has the authority to remove adulterated food from the national food supply, which could include removing food derived from genetically modified plants. The EPA governs the use, sale, and labeling of herbicides used on all plants pursuant to its authority under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) (7 U.S.C. §§ 136–136y). FIFRA governs the use, sale, and labeling of herbicides and EPA’s actions under FIFRA directly effects the production methods used on herbicide resistant GE plants. An herbicide must first be “registered” by the EPA before it can be distributed or sold in the United States (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 effectiveness of the herbicide and any adverse effects it may have on humans and the environment. On the basis of this evaluation, the EPA then determines if it will allow the herbicide’s use on a plant, and, if so, in what quantity. The EPA sets the conditions for the herbicide’s use and places them in labeling instructions that a user must follow (See 7 U.S.C. 136j(a)(2)(G)). The EPA reevaluates the herbicide every fifteen years, as part of a “re-registration process” in which the agency determines if it should continue allowing the herbicide’s use (7 U.S.C.§ 136a(g)(1)(A)(iv)). The Enlist™ corn and soybean that are the subject of this EIS have been engineered to be resistant to the herbicide 2, 4-D. The EPA re- registered 2,4-D in 2005 (US-EPA, 2005b). EPA is currently reviewing the use of 2,4-D on Enlist™ corn and soybean based on the standard that the herbicide would not cause any unreasonable environmental risks so long as it was applied in accordance with its labeling instructions. EPA’s FIFRA regulation deals with pesticides. EPA does not regulate Enlist™ corn and soybean plants, because the plant itself does not produce or secrete a pesticide. ii Purpose of Enlist™ Corn and Soybean DAS has developed Enlist™ GE plant varieties as alternatives to currently available GE herbicide resistant (HR) corn and soybean varieties (see the petitions which are available on APHIS’ website (http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml). Many herbicide resistant corn and soybean varieties have been engineered over the past 15 to 20 years. These include varieties with resistance to the herbicide glyphosate (the active ingredient in Roundup®); varieties resistant to the herbicide glufosinate, (the active ingredient in the herbicide Liberty®); a class of herbicides known as sulfonylureas, (active ingredients in herbicides such as Glean®); and isoxaflutole, (the active ingredient in herbicides such as Balance® and Prequel®). By far, RoundupReady® crops have been the most widely adopted by growers. RoundupReady® crops greatly simplified weed management for growers and reduced their weed management costs. These RoundupReady® crops were so successful that many growers grew only RoundupReady® crops on their farms. As another example of this success, most soybean growers could manage weeds by using glyphosate as the only herbicide, whereas three to four herbicides were previously needed.