TABLE 1.2 Summary of the Current Regulation of Biotechnology Products, as currently described on the USDA website for Regulatory Oversight in Biotechnology




US Department of Agriculture

Plant pests, plants, veterinary biologics

Federal Plant Pest Act

Food and Drug Administration

Food, feed, food additives, veterinary drugs, human drugs, medical devices

Federal Food, Drug, and Cosmetic Act


Microbial and plant-pesticides, new uses of existing pesticides, novel microorganisms

Federal Insecticide, Fungicide, and Rodenticide Act; Federal Food, Drug, and Cosmetic Act; Toxic Substances Control Act

Source: USDA 1999e.

1.4.3 The First Field Trials

In November and December 1987, USDA issued permits for three engineered herbicide-tolerant varieties of tomato (two from DuPont and one from Calgene) and two herbicide-tolerant varieties of tobacco (from Calgene). These plants were tolerant of the herbicides glyphosate, bromoxynil, or sulfonylurea. Tolerance was based on the overexpression of the herbicide target in the tolerant plant, the expression of resistant forms of the target enzymes, or the expression of enzymes that could degrade the herbicide (Comai et al. 1985; Harrison et al. 1996).

Transgenic pest-protected plants were developed in parallel to herbicide-tolerant plants. The first transgenic pest-protected plant was engineered to contain a coat-protein gene from the tobacco mosaic virus (TMV) (Powell-Abel et al. 1986); the gene confers resistance to TMV itself, and to viruses similar to TMV. A transgenic TMV-resistant tomato line developed by Monsanto was approved for field trials on March 23, 1988.

Today, a large portion of US corn and cotton acreage is planted with transgenic pest-protected plants (Economic Research Service 1999a, b; Carozzi and Koziel 1997). Those transgenic pest-protected plants contain genes from the bacterium Bacillus thuringiensis (Bt). Bt produces several proteins during sporulation including endotoxins. Upon ingestion by an insect, the protoxin form of endotoxin undergoes cleavage in the insect gut to a truncated active form, which kills insects by binding to receptors

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