Agricultural Biotechnology: Background and Recent Issues

Tadlock Cowan
Analyst in Natural Resources and Rural Development

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 165 million acres in 2010. Worldwide, 29 countries planted GE crops on approximately 366 million acres in 2010. GE varieties now dominate soybean, cotton, and corn production in the United States, and they continue to expand rapidly in other countries.

Ongoing concerns include the impacts of GE crops on food safety and the environment (e.g., herbicide resistance), the question of whether GE foods should be labeled, and their potential contamination of conventionally raised and organic plants. Underlying these issues is the question of whether U.S. regulation and oversight of biotechnology are adequate, particularly as newer applications (e.g., biopharmaceuticals, stacked GE traits in single organisms) emerge that did not exist when the current regulatory regime was established. The U.S. Food and Drug Administration (FDA) is currently considering approval of the first GE animal for human consumption, a salmon genetically engineered to grow larger than conventional salmon.

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). A 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 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 was published in December 2010, and in February 2011 Secretary Vilsack fully deregulated GE alfalfa. A suit has been filed claiming that this deregulation decision violated the National Environmental Policy Act. 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. In February 2011, APHIS announced that the agency would partially deregulate GE sugar beet root crop, but not sugar beet seed crop production.

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. In a ruling in January 2008, FDA published its final guidance on the safety of meat and milk from cloned animals.

Legislative activity in the 111th Congress included the reintroduction of two bills (H.R. 5578 and H.R. 5579). Two bills have been introduced in the 112th Congress: (H.R. 521/S. 230) to prevent FDA from approving GE salmon, and H.R. 307, the Seed Availability and Competition Act. A provision in the FY2012 House Agriculture appropriations bill (H.R. 2112) would prohibit the approval of GE salmon.


Date of Report: July 5, 2011
Number of Pages: 46
Order Number: RL32809
Price: $29.95

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