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

Residue Analytical Methods

Method submitted, but independent laboratory validation required

June 1, 2002

Protein Expression

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

March 15, 2003

Amino Acid and DNA Sequence

Stepwise 8 amino acid analysis

March 15, 2003

Cry Protein Levels in Soil

Supplemental studies; protocol to be submitted before studies are initiated

Protocol March 15, 2002; interim report January 31, 2003; final report January 31, 2004

Non-target Insects

Either existing studies or protocol and studies

Existing studies or protocol March 15, 2002; studies due January 31, 2005

IRM–north/south movement of

Potential for north to south movement of

cotton bollworm

cotton bollworm

January 31, 2004

IRM–Alternate Hosts/Insecticide

sprays

Alternate host data as an effective refuge and sprays with chemical insecticides to

enhance Bt cotton IRM effectiveness

Protocol December 1, 2001; final protocol March 15, 2002; interim report March 15, 2003 and final March 15, 2004

  • b.

    Gene Flow Containment Provisions

  • i.

    Bt Corn

No provisions.

ii. Bt Cotton

Until thorough research on the impacts of gene flow can be completed, restriction on where Bt cotton can be planted are being implemented. The following terms and conditions must be instituted to mitigate gene flow concerns:

I12

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