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

and $126 million. Indirect benefits may include improved populations of beneficial insects and wildlife in cotton fields, reduced pesticides runoff, reduced air pollution and waste from the use of chemical insecticides, improved farm worker and neighbor safety, and reduction of fossil fuel use. EPA believes that cultivation of Cry1Ac cotton may result in fewer adverse impacts to non-target organisms than result from the use of chemical pesticides.

  • 6.

    Confirmatory Data and Terms and Conditions of the Amendment

    • a.

      Confirmatory Data

    • i.

      Bt Corn

The following table outlines the confirmatory data that must be provided to EPA as a condition of the amendment to the Cry1Ab and Cry1F corn product registrations including the due dates for the protocols and the data.

Description

Due Date June 1, 2002

Analytical method including characterization of the antisera and independent laboratory validation required

Expression data provided for initial registration; confirmatory data required to provide consistency across Bt crops

March 15, 2003

Comparison of AA sequence to known toxins and allergens Stepwise 8 amino acid analysis

March 15, 2003

Stepwise 8 amino acid analysis and processing and/or heat stability study

March 15, 2003

Data

Residue Analytical Methods

Protein Expression

For Bt11: Amino Acid Sequencing

For MON810: Amino Acid Sequencing and heat stability

Cry1Ab Protein Levels in Soil

Supplemental studies; protocol to be submitted before studies are initiated

Protocol by March 15, 2002; interim report 12 months after protocol approved; final report 24 months after protocol approved

Cry1F Protein Levels in Soil

Supplemental studies; protocol to be submitted before studies are initiated

Protocol by March 15, 2002; final report due no later than March 15, 2008

I10

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