Jump to main content.

Bacillus thuringiensis Cry1Ab protein and the genetic material necessary for its production (pTDL004 or pTDL008) in Event T303-3 or T304-40 cotton plants (006525) Experimental Use Permit Fact Sheet

Related Information
Information related to this page:

Issued: EUP Issued: 1st issuance, February 7, 2006

Extension, March 8, 2007

Proposed Active Ingredient Name: Bacillus thuringiensis Cy1Ab protein and the genetic material necessary for its production (pTDL004 or pTDL008) in Event T303-3 or T304-40 cotton plants

OPP Chemical Code: 006525

On This Page

  1. Description of the Active Ingredient
  2. Use Sites, Target Pests, and Application Methods
  3. Regulatory Information
  4. Registrant Information
  5. Additional Contact Information

Summary

The plant-incorporated protectant Bacillus thuringiensis Cry1Ab protein and the genetic material necessary for it production (pTDL004 or pTDL008) in Events T303-3 and T304-40 cotton plants is designed to control lepidopteran pests of cotton including the cotton bollworm (Helicoverpa zea), tobacco budworm (Heliothis virescens), pink bollworm (Pectinophora gossypiella), fall armyworm (Spodoptera frugiperda), and beet armyworm (Spodoptera exigua). Four trial protocols have been proposed:

  1. Description of the Active Ingredient

    2. The proposed active ingredient is Bacillus thuringiensis Cry1Ab protein and the genetic material necessary for its production (pTDL004 or pTDL008) in Event T303-3 or T304-40 cotton plants. Events T303-3 and T304-40 were derived from Agrobacterium tumefaciens-mediated transformation of cotton variety Coker 315 with plasmid pTDL004 and plasmid pTDL008, respectively. The inserted DNA contains the cry1Ab gene from Bacillus thuringiensis and the bar gene from Streptomyces hygroscopicus and regulatory sequences necessary for their expression in cotton. The cry1Ab gene sequence was modified for expression in plants. In each event, one copy of the cry1Ab gene was inserted into cotton.

    The Cry1Ab protein encoded by the gene inserted into cotton is expected to have 617 amino acids and a molecular weight of approximately 69 kDa. The deduced amino acid sequence is identical to the B.t. protein except that it is truncated at the C-terminal end (the B.t. produced protein has a molecular weight of 130 kDa), and an alanine has been inserted at the N-terminal end. In addition, the deduced amino acid sequence of The Cry1Ab protein is identical to the amino acid sequence of the Cry1Ab protein in a previously registered PIP (Bt11, OPP chemical code 006444) with the exception of one amino acid at the C-terminus and two amino acids at the N-terminus. The PAT protein encoded by the bar gene is a homodimer of 183 amino acids and has an expected molecular weight of approximately 22 kDa. The PAT protein in events T303-3 and T304-40 is the same protein that is in a previously commercialized product, BCS LLCotton25.

    The overall amino acid sequence of the Cry1Ab protein was compared with sequences of proteins in publicly available databases. No similarities with known allergens or mammalian toxins were observed based on a criterion of 35% identity over 80 amino acids. No similarities between the Cry1Ab protein and known allergens were identified based on 100% identity over an eight amino acid segment.

    The current tolerance exemptions for Cry1Ab (40 CFR 180.1173) and PAT (40 CFR 180.1151) are applicable to the proteins produced in the Bayer's Events T303-3 and T304-40. The data submitted and cited are sufficient to support the product characterization and human health assessment of the EUP application.

    The data submitted and cited are sufficient to support the environmental risk assessment of the EUP program. Due to the limited acreage and use of a crop-destruct procedure, no hazard is expected to the environment. There are no anticipated significant adverse effects of Cry1Ab proteins on the abundance of non-target beneficial organisms in any population in the field, whether they are pest parasites, pest predators, or pollinators.

    Top of Page

  2. Use Sites, Target Pests, and Application Methods

  3. Regulatory Information

    4. Experimental Use Permit, 264-EUP-140 was issued from February 7, 2006 to January 31, 2007. It is authorized for 15 locations only in the states of Louisiana, Mississippi, North Carolina, Puerto Rico, South Carolina, and Texas. Planting under the EUP will not exceed 370 total acres.

    Experimental Use Permit, 264-EUP-140, was extended from March 8, 2007 to May 1, 2008. It is authorized for 31 locations only in the states of Arizona, California, Georgia, Louisiana, Mississippi, North Carolina, South Carolina, and Texas. The EUP includes 84 acres of Bacillus thuringiensis Cry1Ab cotton and 201 acres of non-Bt plant-incorporated protectant border areas (285 total acres).

  4. Registrant Information

    5. Alejandra Scott, Ph.D.
    Bayer CropScience LP
    2 T. W. Alexander Drive
    Research Triangle Park, NC  27709
    ali.scott@bayercropscience.com
    919-549-2159

  5. Additional Contact Information

    6. Ombudsman, Biopesticides and Pollution Prevention Division (7511P)
    Office of Pesticide Programs
    Environmental Protection Agency
    1200 Pennsylvania Avenue, NW
    Washington, D.C. 20460

Top of Page

Publications | Glossary | A-Z Index | Jobs

Local Navigation

Jump to main content.