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Bacillus thuringiensis Vip3Aa20 protein and the genetic material necessary for its production (vector pNOV1300) in Event MIR162 corn plants (006599) Factsheet Experimental Use Permit

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Experimental Use Permit Issued: March 26, 2007

Active Ingredient Name Bacillus thuringiensis Vip3Aa20 protein and the genetic material necessary for its production (vector pNOV1300) in Event MIR162 corn plants

OPP Chemical Code: 006599

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 Vip3Aa20 protein and the genetic material necessary for its production in Event MIR162 corn plants is designed to control lepidopteran pests of cotton including (among others) the European corn borer (Ostrinia nubilalis), corn earworm (Helicoverpa zea) and southwestern corn borer (Diatraea grandiosella). The Experimental Use Permit program is authorized in 22 states and Puerto Rico. The EUP is effective from March 26, 2007 to March 31, 2008. Planting for the EUP will not exceed 3,309 total acres.

  1. Description of the Active Ingredient

    2. The proposed active ingredient is Bacillus thuringiensis Vip3Aa20 protein and the genetic material necessary for its production (vector pNOV1300) in Event MIR162 corn plants. Event MIR162 was derived from Agrobacterium-mediated transformation of a proprietary line of corn with plasmid pNOV1300. The inserted DNA contains the vip3Aa20 gene from Bacillus thuringiensis strain AB88 and the pmi gene from Escherichia coli and regulatory sequences necessary for their expression in corn.

    The Vip3Aa20 protein encoded by the gene inserted into corn 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 two amino acids. At position 129 of the Vip3Aa20 protein there is an isoleucine (methionine appears at that position in the microbial Bt) while at position 284 the Vip3Aa20 has glutamine (compared with lysine for the microbially-produced protein. In addition, the Vip3Aa20 amino acid sequence is similar to the Vip3Aa19 protein used in cotton (VipCot) – the two differ by the position of a single amino acid at position 129 (Vip3Aa19 has methionine at this position instead of isoleucine). The PMI protein encoded by the pmi gene is a common enzyme involved in carbohydrate metabolism to allow for selection of transformants in cell culture by only allowing transformed corn cells to utilize mannose as a sole carbon source (corn cells without the pmi gene fail to grow).

    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 Vip3Aa20 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 a temporary exemption from the requirement of a tolerance (PP 6G7091), which was issued concurrently with the EUP (40 CFR §174.528). There is an existing tolerance exemption for PMI (40 CFR 174.527) that is applicable to Event MIR162 corn.

    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 March 26, 2007 to March 31, 2008. The EUP is for 22 states and Puerto Rico, not to exceed 3,309 total acres. A temporary exemption from tolerance for Vip3Aa20 protein in corn was established concurrently with the EUP (40 CFR §174.528).

  4. Registrant Information

    5. Dennis Ward, Ph.D.
    Regulatory Affairs Manager
    Syngenta Seeds, Inc.
    3054 Cornwallis Road
    P.O. Box 12257
    Research Triangle Park, NC 27709
    dennis.ward@syngenta.com

  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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