health or environmental issues might not be adequately addressed. In general the committee found that

The scope of product reviews, as delineated by USDA and EPA, has the potential to result in gaps in regulatory coverage.

Concerning USDA's scope, USDA-APHIS oversees field tests of genetically modified crops, including transgenic pest-protected plants. It is the only agency that reviews the environmental and agricultural effects of transgenic pest-protected plants whose pesticidal substances EPA has has proposed to exempt from regulation under FIFRA. The scope of USDA's oversight includes “any organism which has been altered or produced through genetic engineering, if the donor organism, recipient organism, or vector or vector agent belongs to the genera or taxa designated in Section 340.2 and meets the definition of a plant pest” (USDA 1987, section 340.1). Many plants do not automatically meet the definition of a “plant pest.” Thus, the upshot of this language is that, without a specific determination to the contrary, USDA regulations cover only genetically modified plants that have inserted genetic material from plant pests. In practice, USDA regulates genetically engineered plants with insertion vectors and promoters from plant pathogens, such as Agrobacterium tumefaciens and cauliflower mosaic virus. The agency also reviews voluntary submissions from those whose plants are not expressly covered.

Use of a small amount of genetic material from a plant pathogen as a vector or promoter, however, does not result in plants that pose greater plant pest risks than other types of genetically modified plants. The small amount of genetic material from plant pathogens that is inserted into plants does not result in diseased plants (Center for Science Information 1987; Goldburg 1989).

The development of new techniques for genetically engineering crops means that the scope of USDA's regulations might now fail to encompass some genetically engineered crops that the agency wishes to regulate. A number of techniques, such as the use of microprojectile guns, can now be used to insert DNA into plants without the use of the Agrobacterium vector. Genetic engineers can now make genetic constructs with promoters that are no longer automatically subject to USDA oversight, not because they pose any more or less plant pest risk than plants now being regulated by USDA, but simply because of the techniques used to modify them. Although companies developing such plants may voluntarily notify USDA of field tests, it remains to be seen how USDA will regulate (or deregulate) such crops when they are commercialized. Moreover, companies and researchers obviously have considerable discretion whether they continue to notify USDA of field tests without a legal requirement to do so. Therefore, the committee recommends that



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement