beta-conglycinin subunits, and corresponding increase in glycinin subunits. The agency determined that the linoleic acid isomer, present in trace quantities (<1%) in the oil, and the alteration in the seed storage protein subunits should have no adverse effects. The glycinin subunits are common components of soybean and so are unlikely to cause harm. The linoleic acid isomer is also found in other common foods, including partially hydrogenated vegetable oils and human breast milk, so it is unlikely to be harmful in the transgenic soybeans.

Soybean naturally produces antinutritional components, notably trypsin inhibitors, phytic acid, and oligosaccharides. APHIS noted that the presence of antinutritional factors in the transgenic lines were similar to those in conventional soybeans. They also said the presence of DNA from the uidA and bla genes should not have any adverse effects, as they are not expressed in the plant and do not encode infectious agents. APHIS concluded that none of these indirect effects should have any negative impact on non-target organisms.

Potential Impact on Agricultural Commodities. Citing its authority to investigate the potential for plant pest effects, APHIS determined that the subject soybean lines, their components, and their processing characteristics have no indirect plant pest effect on any processed plant commodity.

Based on unspecified evidence provided by DuPont, APHIS concluded that the high oleic soy lines present no threat to raw or processed agricultural commodities. APHIS noted that DuPont consulted with the Food and Drug Administration concerning the safety of consumption of both the oil and meal of these lines by humans and other animals.

Potential Environmental Impacts from Growing the Modified Soybeans outside the United States. Executive Order 12114 (January 4, 1979) allows APHIS to consider the possible environmental impacts of cultivation of regulated articles in other countries. APHIS concluded that the subject soybeans will not have an adverse environmental impact when grown anywhere in the world because there are no significant differences from the parent line for any investigated parameter, except for the higher levels of oleic acid, the glycinin protein substitution, and the linoleic acid isomer. APHIS also noted that “all national and international regulatory authorities and phytosanitary regimes that apply to introductions of new soybean varieties internationally apply equally to those covered by this determination” (USDA 1997a).

Environmental Risks Not Considered by APHIS

APHIS considered the information provided by DuPont and others in reaching its determination, but there is little experimental data in the



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