tended plant protectants. Such pleiotropic effects are sometimes difficult to predict. Furthermore, as outlined in previous (section 2.4.2 and section 2.5), many approaches to producing plant protectants through the use of plants that are sexually compatible with the crop plant can result in crops that produce new compounds owing to linkage between the genes for the plant protectants and genes for the other compounds. FDA needs to address these “unintended compositional changes” carefully during their consultation process with the plant producers. USDA and EPA should also be aware of those unintended changes in evaluating the potential agricultural and ecological effects of pest-protected plants.
The committee recommends that
EPA, FDA, and USDA collaborate on the establishment of a database on natural plant compounds of potential dietary or other toxicologic concern.
The database would be publicly available and updated regularly. The following guidelines should be considered: initial emphasis should be on obtaining baseline profiles for food plants that are known to have toxic constituents and on the commonest varieties; differences among varieties, developmental stages, tissues and environmental conditions are important and should be analyzed after initial average baselines have been established; only information based on state-of-the-art chemistry and analytic methods should be incorporated; and potential information should be peer-reviewed by a committee of experts before it is added to the database (see also section 3.4.1).
Given the above concerns with the scientific basis of proposed oversight, the committee proposes that federal agencies use the following questions as a guide in developing their review process. These decision keys leave sufficient room for agency judgment case by case. For the most part, the agencies are following a similar logic in their decision-making, but there are some points where current decision-making does not agree with the following questions; these discrepancies are pointed out in the text.
Because the Coordinated Framework for the Regulation of Biotechnology was designed for transgenic products (see chapter 1) and the agencies do not actively assess conventional pest-protected plant products, the following questions focus on transgenic pest-protected plant products. However, the questions could be adapted and applied to nonregulatory safety assessments of conventional pest-protected plants, as the underly-