Drought-tolerant phenotypes could be based on higher water use efficiency (WUE), which leads to greater biomass production per unit of water, or an increased ability to extract water from the soil. Thus, there could be health benefits from increasing the level of vitamin E in commonly consumed foods, such as soybean (DellaPenna 1999). Over the long term, new knowledge regarding the physiology and development of plants and their interaction with microorganisms could eventually provide the foundation to modify plant structure and reproduction. Many countries lack sufficient regulatory oversight of environmental impacts, especially the scientific capacity to conduct environmental risk analyses and the administrative capacity to enforce environmental decisions that are made. A more definitive evaluation of the precautionary principle must await more specific criteria for its application in agriculture (Soule 2000). In the worst-case scenario, U.S. producers may effectively be excluded from these emerging world markets, but economic incentives will be affected under any scenario. Issues related to changing agricultural structure might have indirect environmental consequences. Such changes may have already had both economic and environmental impacts. Preliminary research has demonstrated that several types of plant tissues, including seeds and leaves, have the capacity to express genes encoding the protein subunits of monoclonal antibodies and assemble them into functional complexes (Daniell et al. Describing some possible event or set of events in terms of risk always implies that these events are regarded as adverse. Plants with improved water extraction will still require the same amount of water to grow, so potential environmental effects may often be related to competition for sunlight or nutrients in the soil due to the plant’s metabolic needs associated with greater biomass. Accurate assessments of the environmental risks posed by any of these stress-tolerant plants will not be possible until they are actually created because the genetic mechanism of stress tolerance will greatly determine the scope of potential risks. Agricultural biotechnology, just like any other technology, has social and economic impacts. 2001), and genetic activation and suppression screens that influence interrelationships among multiple signaling systems that control stress-adaptive responses in plants (Hasegawa et al. Although government regulation of conventionally modified plants has been virtually nonexistent, the agricultural research establishment has not ignored the potential of genetic modification of crops to result in environmental change. Ozonoff (1998) argues that the precautionary principle should be interpreted as a screening device to apply “scientific evaluations to situations where the proportion of cases that are hazards is high and/or use methods with high specificity, that is, that correctly identify ‘no-hazard’ situations” (104). Nontarget risks associated with these plants with altered nutritional characteristics (both macronutrients and micronutrients), increased concentrations of “health-producing” compounds, or edible vaccines may be considerably more subtle than the direct mortality risks associated with plants producing insecticidal toxins, which are being evaluated presently. Coordinated Framework for the Regulation of Biotechnology has been a frequent subject of discussion throughout the brief history of transgenic crops. There is considerable variation even among contributors to Raffensperger’s and Tickner’s book advocating implementation of the precautionary principle. The Animal and Plant Health Inspection Service (APHIS) appropriately refrains from speculation on environmental risks associated with crops that may or may not reach the stage of commercialization. A second class of modifications aims to optimize food quality by incremental improvements. Annually, 250 million children suffer from vitamin A deficiency, which contributes to illness and death for some 10 million people annually. Some industrial products, such as pharmaceuticals, may be produced on such a limited spatial scale that they would have a negligible impact on total food production, but that is not necessarily the case for all transgenic crops aimed at producing industrial products. However, if the scale of volatilization is large, so that large amounts of mercury are volatilized, levels of atmospheric mercury may rise at regional or larger spatial scales. The promoter used to silence the fatty acid desaturase genes in the high oleic acid transgeneic soybean effectively eliminates expression of one of the major classes of soy proteins that does not contain methionine and cysteine. The result is that some farmers and farm groups take a jaundiced view of the claim that biotechnology responds to on-farm needs for greater efficiency while. 1992), but this was not found to be an economically viable process. In the future there is expected to be a proliferation of novel transgenic traits engineered into crop cultivars involving multiple genes. For example, how should feedback loops be established between validation efforts and long-term monitoring efforts so as to clarify the adequacy of available ecological indicators for monitoring of ecological effects of transgenic crops? Inadequate iron in children’s diets impairs mental development. Most (65 to 70%) of the 9 billion to 10 billion bushels of corn produced annually in this country are used for livestock feed; about 25% is exported, and the remaining 10%. It seems safe to assume, though, that genetically complex traits will require additional years of research to understand, let alone express and regulate in a genetically engineered crop species. Of particular interest are a group of pathogens—Norwalk virus, Vibrio cholerae (the cause of cholera), and enterotoxigenic Escherichia coli (a source of “traveler’s diarrhea”)—that cause the deaths of several million children each year, mainly in developing countries. For example, a Bt gene has been inserted into hybrid poplars to protect them against defoliation by a leaf beetle. For example, regulations could presumably be written giving directives to APHIS on how to involve the public and external scientific experts in its review process. The efficacy of this approach to reducing vitamin A deficiencies remains controversial (Nestle 2001). Alternatively, different promoters could allow greater control of where in the plant the gene product is produced; tissue-specific promoters could preclude expression of pesticidal proteins, for example, in pollen and other tissues. Indeed, as recently as the 1960s, there was starvation in China, resulting in millions of deaths (Brown 1995). The environmental risks associated with such stress-tolerant crops are both complicated and subtle. It is beyond the scope of this report to provide a detailed analysis of this new directive, but suffice it to say that the precautionary principle has been incorporated into at least the labeling and traceability standards, the monitoring standards, and the EU approval process. If, for example, a lower-yielding nontransgenic crop is chosen in lieu of a higher-yielding transgenic alternative, the result could be that fragile lands would need to be planted in order produce needed amounts of food. The European discussion of the precautionary principle has occurred in the context of attempts to harmonize grades, standards, and regulatory approaches among member states. Cotton entomologists (Bradley, 2001, personal communication) have determined that about two-thirds of the increase was caused by farmers who wanted to use glyphosate-tolerant cotton and therefore needed to purchase a cultivar that contained the Bt gene. The broad language of the new Plant Protection Act defines “plant pest” as including all vertebrate and invertebrate animals except humans.