date provides a very limited basis for predicting questions needed to be asked when plants with very different phenotypic traits are assessed for environmental risks. For example, the production of non-edible and potentially harmful compounds in crops such as cereals and legumes that have traditionally been used for food creates serious regulatory issues. With few exceptions, the environmental risks that will accompany future novel plants cannot be predicted. Therefore, they should be evaluated on a case-by-case basis.

In the future many crops can be expected to include multiple transgenes. The current APHIS approach for deregulation does not assess the environmental effects of stacking multiple genes into single-crop varieties. There are at least two levels at which scientists and regulators must look for interactions between such inserted genes with regard to environmental effects. The first level is interactions of genes and gene products that affect the individual plant phenotype. The second is the whole-field or farming systems level. One of the case studies examined by the committee finds early indications that gene stacking can have environmental effects at the farming systems level.

The types of new transgenic crops that are developed, as well as the rate at which they appear, will be affected by the interaction of complex factors including public funding and private financial support for research, the regulatory environment, public acceptance of the foods and other products produced from them, and the resolution of debates over need- versus profit-driven rationales for the development of transgenic crops.

For future novel products of biotechnology, adequate risk analysis for decision support and maintenance of authority will depend on a regulatory culture that reinforces the seriousness with which environmental risks are addressed. Public confidence in biotechnology will require that socioeconomic impacts are evaluated along with environmental risks and that people representing diverse values have an opportunity to participate in judgments about the impact of the technology.

Currently, APHIS environmental assessments focus on the simplest ecological scales, even though the history of environmental impacts associated with conventional breeding points to the importance of large-scale effects. The committee recommends that in the future APHIS should include any potential impacts of transgenic plants on regional farming practices or systems in its deregulation assessments.

APHIS has been constrained in its risk analysis and decision-making process by the statutes through which it may regulate transgenic plants. In May 2000, the U.S. Senate and House of Representatives agreed in a conference report on a new Plant Protection Act (PPA). The new regulations that will be used to enforce the PPA have not yet been developed.



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