agement and the potential to affect the use of Bt foliar spray products adversely. EPA–USDA collaborative efforts to develop pest management centers offer a nonregulatory approach that could serve as a model for handling other issues that might arise in the future. EPA should continue to deal seriously with Bt resistance management and any other transgenic pest-protected plants that present similar concerns, but,

Where regulation is not warranted, agencies should look for appropriate opportunities to promote nonregulatory mechanisms to address issues associated with transgenic pest-protected plant products, including encouraging development of voluntary industry consensus standards and product stewardship programs.

As new transgenic pest-protected plant products are developed, the kinds of information necessary to support the agencies' risk assessments and regulatory determinations continue to evolve. Although agency reviews are risk based, there are differences in data requirements and in the emphasis placed on different kinds of data. Relatively little formal, detailed guidance to applicants is available. Each agency has taken a somewhat different approach in developing and providing guidance.

EPA included in its 1994 proposed policy a section on information needs and general considerations for product development and commercialization. It provides points to consider in the development of data on product identity and characterization, human health effects, ecological effects, fate of plant-pesticides in the environment, and movement via gene flow. The committee found that

In part because EPA does not have final regulations indicating the scope of products subject to FIFRA registration, relatively little formal guidance is available to companies seeking to determine the kinds of data and information that must be developed to support EPA registration of the pesticidal substances expressed by these plants.

Nevertheless, EPA is imposing data requirements and registering products case by case, creating an urgent need for companies to know to the fullest extent possible what the requirements are. Applicants can now review the existing EPA and other guidance documents, examine what previous applicants have done, and then have a presubmission consultation to seek clarification from EPA on information needs.

FDA's guidance includes its 1992 policy statement regarding the development of foods derived from new plant varieties. That document

Front Matter (R1-R24)

Executive Summary (1-18)

1. Introduction and Background (19-39)

2. Potential Environmental and Human Health Implications of Pest-Protected Plants (40-103)

3. Crossroads of Science and Oversight (104-143)

4. Strengths and Weaknesses of the Current Regulatory Framework (144-181)

References (182-208)

Appendix A: Costs of Regulating Transgenic Pest-Protected Plants (209-237)

Appendix B: Example of Data Submitted to Federal Agencies (238-240)

Appendix C: Committee on Genetically Modified Pest-Protected Plants Public Workshop (241-245)

Appendix D: Acronyms (246-246)

Appendix E: Scientific and Common Names (247-248)

Appendix F: Committee and Staff Biographical Information (249-254)

Index (255-264)