The committee found that the three agencies have common data requirements specifically for biology of the recipient plant, molecular biology methods used to develop the product, identification and characterization of inserted genetic material and its product(s), and identity and characterization of selectable markers. Therefore, the committee recommends that
To enhance consistency of review, EPA, USDA, and FDA should develop a joint guidance document for applicants that identifies the common data and information the three agencies need to characterize products.
Taking into account the above suggestions, the committee hopes that the regulatory framework for transgenic pest-protected plants can be quickly completed by clarifying, revising, and finalizing the EPA 1994 proposed rule; publishing guidance on regulatory requirements; and developing additional interagency MOUs. However, once established, the committee recommends that
Regulations should be considered flexible and open to revision, so that agencies can adapt readily to new information and improved understanding of the science that underlies regulatory decisions. The agencies have attempted to maintain a dynamic regulatory process, but more could be done to retain flexibility in the future (see chapter 4).
Positive impacts of regulation might include reduced health and environmental effects and increased consumer confidence in the food supply. However, there are also economic costs associated with the regulation of transgenic pest-protected plants. The committee reviewed an analysis on the economic costs of regulation (section 4.4 and appendix A14). From this review and other discussions in chapter 4 (see section 4.2 and section 4.3), the committee concludes that regulators should be sensitive to the unique issues facing researchers, plant breeders, and seed distributors, particularly those in the public sector or those who have not traditionally been subject to federal regulation. In particular, the committee recommends that
This appendix was authored by an individual committee member and is not part of the committee's consensus report. The committee as a whole may not necessarily agree with all of the contents of appendix A.