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Bt Plant-Incorporated Protectants October 15, 2001 Biopesticides Registration Action Document

The Bt cotton comprehensive reassessment has been completed and the Bt cotton registration is now set to automatically expire on September 30, 2006 except for the external, unsprayed refuge option which will expire September 30, 2004.

The Bt corn comprehensive reassessment has been completed and the Bt corn registrations are now set to automatically expire on October 15, 2008.

During this reassessment, EPA has conducted an open and transparent public process that incorporated sound and current science, and substantial public involvement.

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-Incorporated Protectants October 15, 2001 Biopesticides Registration Action Document has nine major sections:

    • 1.

      Product Characterization

    • 2.

      Human Health Assessment

    • 3.

      Ecological Assessment

    • 4.

      Insect Resistance Management

    • 5.

      Benefits.

    • 6.

      Bt Cotton Confirmatory Data and Terms and Conditions of the Amendment

    • 7.

      Regulatory Position on Bt Cotton.

    • 8.

      Bt Corn Confirmatory Data and Terms and Conditions of the Amendment

    • 9.

      Regulatory Position on Bt Corn.

  • 1.

    Product Characterization and Human Health Assessment

This section provides information on the specific transformation systems that were used for each product, the characterization of the DNA insert, the inheritance and stability characteristics of the product line, and the protein characterization and levels of Bt protein expression for the various plant tissues. Specific information and data for each of the registrations seeking renewal are included in tabular and descriptive formats.

The health effects assessment confirms EPA’s original findings that there are no unreasonable adverse health effects from these products. The human health assessment for the Bt plant- incorporated protectants draws heavily on the science and toxicology of proteins. All the currently registered Bt plant-incorporated protectants are proteins. The source bacterium has been a registered microbial pesticide which has been approved for use on food crops. The Bt proteins approved for use in food are expected to behave as would be expected of a dietary protein. The Bt microbial pesticides have a long history of safe use without adverse health or environmental effects. Several

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