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Friday, April 12, 2013

Agricultural Biotechnology: Background, Regulation, and Policy Issues

Tadlock Cowan
Analyst in Natural Resources and Rural Development

Biotechnology, as used in this report, refers primarily to the use of recombinant DNA techniques to genetically modify or bioengineer plants and animals. Most crops developed through recombinant DNA technology have been engineered to be tolerant of various herbicides or to be pest resistant through having a pesticide genetically engineered into the plant organism. 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 dozen years, GE varieties in the United States have increased from 3.6 million planted acres to 171.7 million acres in 2012. Worldwide, 28 countries planted GE crops on approximately 420.8 million acres in 2012. GE varieties now dominate soybean, cotton, and corn production in the United States, and they continue to expand rapidly in other countries. They are regulated under three federal agencies, the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA).

Ongoing concerns include ownership concentration in the global seed industry, plant patenting and licensing contracts, the impacts of GE crops on the environment (e.g., pest and weed resistance), whether GE foods should be labeled, their potential contamination of conventionally raised and organic plants, and issues of liability. Underlying these issues are concerns about the adequacy of regulation and oversight of GE organisms, particularly as newer applications (e.g., biopharmaceuticals, multiple GE traits in single organisms, GE trees, GE insects) emerge that did not exist when the current regulatory regime was established in 1986. The FDA is currently considering approval of the first GE animal for human consumption, a salmon genetically engineered to grow faster than conventional salmon. Global trade issues involving GE organisms are a long-standing issue, and will be particularly salient in upcoming U.S.-EU trade discussions.

Regulatory non-compliance incidents most pointedly raise concerns about the adequacy of existing U.S. regulatory structures. About 16 major events have occurred since 1995. A more recent concern has been the adequacy of USDA Animal and Plant Health Inspection Service’s (APHIS) 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, and ordered APHIS to complete an environmental impact statement (EIS). The final EIS was published in December 2010, and USDA fully deregulated GE alfalfa. A similar case involved APHIS’s decision in 2005 to deregulate GE sugar beets on the basis of its EA. In February 2011, APHIS announced that the agency would partially deregulate GE sugar beet until the EIS was completed. In July 2012, GE sugar beets were completely deregulated following publication in June of the final EIS.

In the 113
th Congress, three GE-related bills have been reintroduced: the Seed Availability and Competition Act (H.R. 193); a bill to require labeling of GE fish (H.R. 584/S. 248); and a bill (S. 246) to prohibit interstate and foreign sales of GE salmon. On March 24, 2013, a Senate budget resolution also approved an amendment favoring mandatory labeling of GE fish. The Senate Continuing Resolution (H.R. 933, Section 735) enacted on March 26, 2013, requires USDA to issue permits to growers to plant and market a GE plant even though a court may have vacated the deregulation decision and ordered further review, as happened with GE alfalfa and sugar beets. Similar language was included in the House-passed FY2013 agriculture appropriation bill (H.R. 5973, Section 733). The 2012 House farm bill (H.R. 6083) contained provisions that would have significantly modified current regulations for GE plants under the Plant Protection Act. Another provision in that bill directs USDA to develop a national policy for low-level presence of . GE material in crops and commodities for food and processing. The Senate farm bill did not contain these provisions. Farm bill action is pending in the 113th Congress and could be a vehicle for further legislation affecting biotechnology.

Date of Report: April 3, 2013
Number of Pages: 52
Order Number: RL32809
Price: $29.95

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