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U.S. soybean, cotton, and corn farmers have rapidly adopted genetically engineered (GE) varieties of these crops since their commercialization in the mid-1990s. Over the last decade, GE varieties in the United States have increased from 3.6 million acres to 143 million acres. Worldwide, 25 countries planted GE crops on approximately 309 million acres in 2008. GE varieties now dominate soybean, cotton, and corn production in the United States, and they continue to expand rapidly in other countries. As adoption has spread, policy debates have continued over the costs and benefits of GE products.
Ongoing concerns include the impacts of GE crops on the environment and food safety, and whether GE foods should be specially labeled. Underlying these issues is the question of whether U.S. regulation and oversight of biotechnology—with responsibilities spread primarily among the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA)—are adequate, particularly as newer applications, for example, biopharmaceuticals (drugs manufactured with the use of GE crops or animals) or stacked GE traits in single organisms, emerge that did not exist when the current regulatory regime was established.
Regulatory noncompliance incidents most pointedly raise concerns about the adequacy of existing U.S. regulatory structures. About 16 major events have occurred since 1995, according to USDA’s Animal and Plant Health Inspection Service (APHIS). Another recurring concern has been the adequacy of APHIS’s environmental assessments (EAs) for deregulating GE plants. In 2006, a U.S. district court held that USDA’s EA for a variety of GE alfalfa was inadequate for issuing a finding of no significant impact (FONSI); the court vacated APHIS’s decision to deregulate GE alfalfa and ordered APHIS to complete an environmental impact statement (EIS). The federal court subsequently enjoined further planting until the EIS was completed. In July 2010, the Supreme Court overturned the federal court’s decision to enjoin planting. The final EIS is expected by the end of the year, but APHIS has not indicated an intent to allow planting under a “partial deregulation” in the interim. A similar case involves APHIS’s decision in 2005 to deregulate GE sugar beets on the basis of its EA. That decision was also challenged, and the federal court vacated the deregulation of the GE sugar beets and ordered APHIS to complete an EIS. In July 2010, the federal court declined to enjoin GE sugar beet planting, but in vacating APHIS’s decision to deregulate the GE beets, the court has effectively halted planting, except under regulated conditions. APHIS is currently evaluating a request to partially deregulate GE sugar beets for 2011.
In October 2008, APHIS announced the first revision of its biotechnology regulations since their promulgation in 1987. Proposed changes include a multi-tiered permitting system, new risk categorizations for assessing environmental releases of GE organisms, regulation of GE plants that produce pharmaceutical and industrial compounds, and new standards for low-level presence of regulated GE products. A final rule on the proposed changes has not yet been published. Other recent issuances include FDA’s January 2009 final guidance on regulation of GE animals and products. APHIS is now seeking public comment and data concerning ongoing and future research on GE animals. In a ruling in January 2008, APHIS published its final guidance on the safety of meat and milk from cloned animals.
Legislative activity in the 111th Congress was modest. Two bills (H.R. 5578 and H.R. 5579) were introduced by Representative Kucinich, who had introduced similar bills in previous years.