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Bacillus thuringiensis Vip3Aa19 protein and the genetic material necessary for its production (vector pCOT1) in Event COT102 cotton plants (006499) Experimental Use Permit Factsheet

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Experimental Use Permit Issued: April 26, 2007

Active Ingredient Name Bacillus thuringiensis Vip3Aa19 protein and the genetic material necessary for its production (vector pCOT1) in Event COT102 cotton plants

OPP Chemical Code: 006499

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 Vip3Aa19 protein and the genetic material necessary for its production in Event COT102 cotton plants is designed to control lepidopteran pests of cotton including the tobacco budworm (Heliothis virescens), cotton bollworm (Helicoverpa zea) and pink bollworm (Pectinophora gossypiella). The Experimental Use Permit program is authorized in 22 states and Puerto Rico. The EUP is effective from April 26, 2007 to April 30, 2008. Planting for the EUP will not exceed 1,359 total acres.

  1. Description of the Active Ingredient

    2. The active ingredient is Bacillus thuringiensis Vip3Aa19 protein and the genetic material necessary for its production (vector pCOT1) in Event COT102 cotton plants. Event COT102 was derived from Agrobacterium-mediated transformation of cotton using elements of a vector (pCOT1) containing a variant of the vip3A(a) gene isolated from Bacillus thuringiensis strain AB88. COT102 cotton also contains the aph4 gene which encodes the selectable marker enzyme, hygromycin B phosphotransferase (APH4). The APH4 protein is inert with respect to pesticidal activity in the cotton plants.

    The Vip3Aa19 protein encoded by the gene inserted into COT102 has 789 amino acids and a molecular weight of approximately 89 kDa. The deduced amino acid sequence is identical to the microbial Bt protein except for one amino acid. At position 284 of the Vip3Aa19 protein there is a glutamine (compared with lysine for the microbially-produced protein). In addition, the Vip3Aa19 amino acid sequence is similar to the Vip3Aa20 protein used in corn (MIR 162) – the two differ by the position of a single amino acid at position 129 (Vip3Aa19 has methionine at this position instead of isoleucine).

    The data submitted and cited are sufficient to support the product characterization and human health assessment of the EUP application. An acute oral toxicity study conducted with Vip3A showed no evidence of toxicity for the protein. The overall amino acid sequence of the Vip3Aa19 protein was compared with sequences of proteins in publicly available databases. No similarities with known allergens or mammalian toxins were observed. Further, data revealed that Vip3A is degraded rapidly by gastric fluid in vitro.

    Syngenta applied for an extension (PP 3G6547) to an existing temporary exemption from the requirement of a tolerance (40 CFR §174.501) for Vip3Aa19, which was issued concurrently with the EUP. There is an existing tolerance exemption for APH4 (40 CFR §174.526) that is applicable to Event COT102 cotton.

    The non-target and ecological 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 Vip3A proteins on the abundance of non-target beneficial organisms in any population in the field, whether they are pest parasites, pest predators, or pollinators.

  2. Use Sites, Target Pests, And Application Methods

  3. Regulatory Information

    4. An Experimental Use Permit has been approved to run from April 26, 2007 to April 30, 2008. The EUP is for 16 states, not to exceed 1,359 total acres. A temporary exemption from tolerance for Vip3Aa19 protein in cotton (40 CFR §174.501) was extended concurrently with the EUP.

  4. Registrant Information

    5. Janet Reed
    Regulatory Affairs Manager
    Syngenta Seeds, Inc.
    3054 Cornwallis Road
    P.O. Box 12257
    Research Triangle Park, NC 27709
    janet.reed@syngenta.com
    phone: (919) 765-5076

  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

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