A. Executive Summary EPA is currently engaged in a comprehensive reassessment of the time-limited registrations for all existing Bt corn and cotton plant-pesticides. This reassessment has been designed to assure that the decisions on the renewal of these registrations are based on the most current health and ecological data. Current registrations are set to expire September 30,200 1. As part of EPA's reassessment, the Agency will decide whether to extend the registrations and whether to include any additional terms and conditions of such registrations for issues including insect resistance management, the protection of non-target organisms, strengthened compliance programs, and other measures necessary to ensure full public and environmental safety. Although Bt potato does not have an expiring registration, EPA has also included information on this plant-pesticide in this document.During this reassessment, EPA is conducting an open and transparent public process that incorporates sound and current science, public involvement, and balanced decision making. The major components of the process and time frames for action are as follows: Comprehensive risk and benefit assessments. This review incorporated all available scientific information on Bt products, including results of recent scientific studies and recommendations from various individuals and organizations. (Summer/Fall 2000) Completed.Scientific Peer Review and public comment. After completing our scientific risk and benefit assessment, the Agency provided the registrants of the products an opportunity to review the assessment and suggest technical corrections to the Agency. After technical corrections were made, EPA released the risk and benefit assessments and invited public comment and scientific peer review. That release included EPA's regulatory assessment and the underlying data, along with registrants' technical error correction comments and the corrective actions taken by the Agency. All of these materials were placed in the Bt crop reassessment docket. (Fall 2000) Completed.Recommendations from the Scientific Advisory Panel, National Academy of Sciences. public comments, and the Administration-wide review. Since there are many organizations providing regulatory and scientific recommendations, EPA used the time since the SAP report in March to consider and incorporate as appropriate recommendations into our revised risk and benefits assessments. This included recommendations from the public and the Scientific Advisory Panel on insect resistance management, ecological and public health aspects of our regulatory program, along with consideration of issues identified in the report released by the National Academy of Sciences titled: 'Genetically Modified Pest-Protected Plants, Science and Regulation' and the Administration-wide review on the regulation of biotechnology products. (Fall 2000, Winter 2000/l, Spring/Summer 2001) Completed. SAP Meeting Held October l&19, and 20, 2000. SAP Report Released March 12, 2001.Revised risk assessments and proposed regulatory options. EPA has considered all of the public comments and the recommendations from the SAP in revising the risk and benefits assessments, and in developing elements to be included in risk mitigation and the potential options for regulatory decisions. EPA will hold a technical briefing to describe the revised scientific reassessment and take comments on potential regulatory options. (Summer 2001) Ongoing.Final decisions on Bt registrations. This will complete the scientific and public process. EPA will continue to take public comments for 45 days from the publication of the technical briefing Federal Register Notice before announcing any registration decisions for future growing seasons on or before September 30,200 1. Summer/Fall 2001 The complete reassessment document is fashioned after the Agency's traditional Reregistration Eligibility Document (RED). This format was selected to present the data and findings in a format that is familiar to the registrants, the users and the general public. The Bt Plant-Pesticides Biopesticides Registration Action Document (BRAD) Revised Risk and Benefits Sections document has five major sections: 1. Product Characterization 2. Human Health Assessment 3. Ecological Assessment 4. Insect Resistance Management 5. Benefits.The Executive Summary includes one additional section, Other Considerations. A Risk Mitigation and Regulatory Decision section is currently being developed. A risk mitigation and regulatory decisions section will be added when the final decisions are made.