The basic federal guidance for regulating biotechnology products is the Coordinated Framework for Regulation of Biotechnology (51 Federal Register 23302), published in 1986 by the White House Office of Science and Technology Policy (OSTP). A key regulatory principle is that genetically engineered (GE) products should continue to be regulated according to their characteristics and unique features, not their production method—that is, not on the basis of their creation through biotechnology. The framework provides a regulatory approach intended to ensure the safety of biotechnology research and products, using existing statutory authority and previous agency experience with traditional breeding techniques. The three lead agencies are U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS), the Food and Drug Administration (FDA) at the Department of Health and Human Services, and the Environmental Protection Agency (EPA). APHIS regulates the importation, interstate movement, and field testing of GE plants and organisms that are or might be plant pests under the Plant Protection Act of 2000 (PPA; 7 U.S.C. §§7701 et seq. ). Because the Coordinated Framework for Regulation of Biotechnology regulates GE plants under existing authorities, APHIS's guiding statutory authority under the PPA became the vehicle by which APHIS regulated plants that had been genetically modified to produce novel proteins, such as those conferring herbicide tolerance and pest resistance. GE plants that are or might be plant pests are considered "regulated articles" under APHIS regulations (7 C.F.R. §§340-340.9). APHIS authorization must be obtained prior to import, interstate movement, or environmental release, including field testing. In the 1986 Framework document, USDA published proposed rules under the PPA that would allow it to regulate outdoor uses of transgenic plants. These regulations were finalized in June 1987 in essentially the same form as the proposed rules. Technically, the PPA regulations do not cover all genetically engineered plants. The regulations cover only those plants engineered to contain DNA sequences from certain genera containing species that were considered to be potential plant pests. The regulations included a broad list of such genera; and this had the practical effect of causing most transgenic plants to be captured by the regulations. A "regulated" plant cannot be introduced into the environment unless its developer obtains APHIS authorization through either the permit process or the notification process. Permits impose restrictions on movement and planting to prevent escape of plant material that may pose a pest risk. Developers follow APHIS guidance on testing and movements to ensure that the plant will not damage agriculture, human health, or the environment, including the human environment. Most GE crops have been developed under the notification option, an expedited procedure that is less rigorous than permitting. Notification can be used in lieu of permitting when the plant species is not considered a noxious weed (or a weed in the release area) and other APHIS standards are met. After a GE variety is approved for release into the environment on a trial basis, the developer of the GE seed typically petitions APHIS for "deregulated status" of the particular GE "event" that has been initially approved. This is the last step to full-scale commercialization of the GE plant. Once the GE plant is deregulated, it is no longer subject to APHIS regulation under 7 C.F.R. Part 340. A significant step in this deregulation process involves an assessment of the plant's environmental impact, including impacts on the human environment. The National Environmental Policy Act (NEPA) requires federal agencies to prepare a detailed environmental impact statement (EIS) for all "major Federal actions significantly affecting the quality of the human environment." The "human environment" includes socioeconomic impacts that might arise from the major federal action. If an agency is unsure of the significance of any environmental impacts, it may prepare an environmental assessment (EA), which is a limited review. Based on the conclusions of that review, the agency can decide an EIS is needed because of the impacts found, or it may issue a "finding of no significant impact," known as a FONSI. Monsanto Corporation, the developer of herbicide-tolerant varieties of GE alfalfa and sugar beet (marketed under the name of Roundup Ready alfalfa and Roundup Ready sugar beet), petitioned APHIS for deregulation of these items in 2004 (for GE alfalfa) and 2005 (for GE sugar beets). APHIS conducted EAs of the GE plants to assess the impacts of growing them on a commercial scale. APHIS issued EA-FONSIs for GE alfalfa in June 2005 and for GE sugar beets in March 2005. Both of these EA FONSIs were challenged in separate lawsuits. The courts found that APHIS's environmental assessments were inadequate. These two cases are discussed in detail below (see " Legal Challenges of APHIS Environmental Assessments and Injunctions "). Alfalfa is the fourth-largest crop grown in the United States, with nearly 23 million acres of alfalfa harvested annually. It is a perennial that can be planted in the spring and fall, and a typical field may be harvested three or four times a year. The crop can remain productive for several years and is often rotated with other crops because it improves the soil's nitrogen content. While nearly all states grow some alfalfa, most alfalfa acreage is in the West and Midwest, including California, South Dakota, Wisconsin, Idaho, Iowa, and Minnesota. Most alfalfa is grown for hay or forage for livestock, primarily for dairy cattle, beef cattle, and horses. A portion of the crop also is grown for seed, mostly in the western United States. Weed management in alfalfa fields is a long-standing concern for alfalfa producers. One of Monsanto's GE innovations is the development of plant varieties that are tolerant of the broad-spectrum herbicide glyphosate, marketed under Monsanto's Roundup trademark. Roundup Ready (RR) soybeans, cotton, canola, and corn are widely planted varieties that express this genetically engineered trait. With Monsanto's development of GE alfalfa—the first perennial to be genetically engineered—a grower can apply a glyphosate-based herbicide to the field after weeds have germinated and not harm the growing alfalfa plant. Concerns about increasing weed-tolerance stemming from the widespread use of glyphosate on GE varieties, and questions about the toxicity of glyphosate, continue to be raised. As noted above, APHIS regulates the release into the environment of "organisms and products altered or produced through genetic engineering that are plant pests or are believed to be plant pests." These "regulated articles" are field-tested subject to APHIS's performance standards governing releases into the environment. APHIS authorized field trials for GE alfalfa in 1998. Monsanto subsequently submitted protocols to APHIS that included a 900-foot buffer zone between the GE alfalfa and non-GE alfalfa, and confinement of flowering plants in cages so that pollinators (e.g., bees) could not get access. The protocols also required that GE alfalfa be destroyed when the field trials ended, that plant residue be disked into the soil, and that the fields be labeled and monitored for one growing season. From 1999 to 2005, APHIS authorized 297 field trials for GE alfalfa. Following nearly eight years of field trials, Monsanto and Forage Genetics International submitted a petition to APHIS in May 2003 requesting deregulated status of two lines of GE alfalfa under the Plant Protection Act. Deregulating a GE item is a "major federal action" and, as such, NEPA requires APHIS to review the environmental implications of the deregulation, preparing either an EA or an EIS. As noted above, an EA can be used to determine whether an EIS is necessary. But APHIS found an EIS was not required by the circumstances. On June 27, 2005, following review of public comments on the draft EA, APHIS announced in the Federal Register its decision to deregulate GE alfalfa and issued a FONSI. APHIS essentially concluded that GE alfalfa exhibited no plant pathogenic properties that could have environmental impacts, and, consequently, that an EIS was not required. The EA is a more limited assessment of the environmental impacts of an action, and the decision to issue a FONSI rather than conduct an EIS led to a legal challenge. This challenge (litigation discussed below) resulted in a court directing APHIS to prepare an EIS. On December 14, 2009, following litigation (discussed below), APHIS announced that its draft EIS concerning GE alfalfa was available for public comment. The comment period, which was extended, ended March 3, 2010. The final EIS, which addresses the 244,000 comments received on the draft EIS, was published on December 16, 2010. The final EIS examined three possible outcomes: (1) complete deregulation, (2) continuing the plant's regulated status, and (3) partial regulation with geographic restrictions and isolation distances on production of GE alfalfa seed and, in some locations, hay production. On January 27, 2011, Secretary Vilsack announced that APHIS was granting GE alfalfa full deregulation. The stated basis of the decision was that GE alfalfa posed no greater plant pest risk than other conventional alfalfa varieties. APHIS concluded that any option other than full deregulation was inconsistent with their regulatory authority under the Plant Protection Act. In the EIS, APHIS identified both the complete deregulation and the partial/conditional deregulation as preferred alternatives.