in the 1960s and 1970s (see Chapter 2). Government agencies charged with the regulation of transgenic plants find themselves in the difficult position of enforcing a much higher environmental standard for these plants than the standards currently used to regulate the impacts of other agricultural technologies and practices. If, as we move further into the twenty-first century, stresses on the environment and public concern about those stresses increase, it is likely that new standards developed for transgenic plants will be applied in some fashion to other agricultural technologies and practices. In that sense, decisions now being made with regard to transgenic plants could set a precedent for evaluating all of agriculture. Government agencies and the public must, therefore, keep an eye to the future when working to develop new environmental standards for transgenic plants.


Potential controversy over agricultural biotechnology was anticipated by the U.S. government in the early 1980s. Before any agricultural products of genetic engineering had been developed, the federal government began taking steps to develop a regulatory structure that would assure the safety of potential products. In the mid-1980s the U.S. Coordinated Framework for the Regulation of Biotechnology was developed. This framework (OSTP 1986) calls for the Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), and Food and Drug Administration (FDA) to work together in assessing the safety of the process and products of genetic engineering. In its current form, the coordinated framework gives the USDA the lead role in assessing the potential effects of nonpesticidal transgenic plants on other plants and animals in both agricultural and nonagricultural environments. The EPA takes the lead role in assessing the health and environmental effects of plants engineered to produce pesticidal substances, and the FDA leads the review of potential health effects of nonpesticidal transgenic plants.

Over the past 15 years the USDA’s Animal and Plant Health Inspection Service (APHIS) has developed a system for examining potential environmental effects of transgenic plants. However, there has been concern that an agency with a mandate to promote U.S. agriculture may not be able to objectively assess the safety of new products of agricultural biotechnology. In July 1999, then Secretary of Agriculture, Dan Glickman, publicly expressed concern over this situation, which later resulted in a request for the National Academy of Sciences (NAS) to examine the scientific basis for, and the operation of APHIS regulatory oversight, to ensure that the commercialization of engineered plants is appropriately regulated.

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