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Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for their production (plasmid insert PHP 17662) in Event DAS-59122-7 corn (006490) Federal Register Notices

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GPO Federal Register

2004 |  2003

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2005
9/21/05 Tolerance Exemption Established - This regulation establishes an exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for their production in corn on corn, field; corn, sweet; and corn, pop when applied/used as a plant-incorporated protectant. Mycogen Seeds c/o Dow AgroSciences LLC submitted a petition to EPA requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for their production in corn.
8/10/05 Experimental Use Permits Granted - EPA has issued the following EUPs, (each of these being granted for specific uses and selected states):

68467-EUP-7. Amendment/Extension. Mycogen Seeds, c/o Dow AgroSciences LLC, of Indianapolis, IN. This EUP allows the use of 2,734.85 grams Cry34Ab1 and 10.88 grams Cry35Ab1 of the insecticides Cry34/35Ab1 proteins and the genetic material necessary for their production (from the insert of plasmid PHP17662) in corn on 3,096 acres of corn. The EUP is effective from January 21, 2005 to April 30, 2006.

29964-EUP-5. Amendment/Extension. Pioneer Hi-Bred International, Inc. of Johnston, IA. This EUP allows the use of 1,813.6 grams Cry34Ab1 and 47.2 grams Cry35Ab1 of the insecticides Cry34/35Ab1 proteins and the genetic material necessary for their production (from the insert of plasmid PHP17662) in corn on 5,115 acres of corn. The EUP is effective from January 25, 2005 to April 30, 2006.
6/03/05 Application for New Active Ingredient - EPA received applications as follows to register pesticide products containing active ingredients not included in any previously registered products:

1. File Symbol: 29964-L. Applicant: Pioneer Hi-Bred International, A Dupont Company, Johnston, IA. Product Name: Herculex Xtra Insect Protection. Plant-incorporated protectant. Active ingredient: Bacillus thuringiensis Cry34/35Ab1 insecticidal crystal protein and the genetic material for its production (plasmid insert PHP 17662) in event DAS-59122-7 corn and Bacillus thuringiensis Cry1F protein and the genetic material for its production (plasmid insert PHI 8999) in corn. Proposed classification/Use: None. For use on corn.

2. File Symbol: 68467-A. Applicant: Mycogen Seeds c/o Dow AgroSciences LLC, Indianapolis, IN. Product Name: Mycogen Seeds Herculex Xtra Insect Protection. Plant-incorporated protectant. Active ingredient: Bacillus thuringiensis Cry34/35Ab1 insecticidal crystal protein and the genetic material for its production (plasmid insert PHP 17662) in event DAS-59122-7 corn and Bacillus thuringiensis Cry1F protein and the genetic material for its production (plasmid insert PHI 8999) in corn. Proposed classification/Use: None. For use on corn.

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2004
12/22/04 Experimental Use Permits Granted - EPA has issued the following EUPs:

68467-EUP-7. Extension/Amendment. Mycogen Seeds c/o Dow AgroSciences LLC of Indianapolis, IN. This EUP allows the use of 0.94 pounds of the plant-incorporated protectant Bacillus thuringiensis Cry34/35Ab1 proteins and the genetic material necessary for their production (from the insert of plasmid PHP17662) in corn on 1,177 acres of field corn in Arizona, Colorado, Delaware, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Dakota, Ohio, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Wisconsin, and Vermont. The EUP is effective from April 29, 2004 to April 30, 2005.

29964-EUP-5. Extension/Amendment. Pioneer Hi-Bred International of Johnston, IA 50131-0552. This EUP allows the use of 3.97 pounds of the plant-incorporated protectant Bacillus thuringiensis Cry34/35Ab1 proteins and the genetic material necessary for their production (from the insert of plasmid PHP17662) in corn on 4,690 acres in Alabama, Arkansas, California, Colorado, Delaware, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, North Carolina, North Dakota, Ohio, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Washington, and Wisconsin. The EUP is effective from April 29, 2004 to April 30, 2005.
9/01/04 Application for New Active Ingredient - EPA received applications to register pesticide products containing active ingredients not included in any previously registered products, as follows:
  1. File Symbol: 29964-U. Applicant: Pioneer Hi-Bred International, A Dupont Company, of Johnston, IA. Product Name: Pioneer Brand B.t. Cry34/35Ab1 Insect Resistant Corn Seed. Plant-incorporated protectant. Active ingredient: Bacillus thuringiensis Cry34/35Ab1 insecticidal crystal protein and the genetic material for its production (plasmid insert PHP 17662) in event DAS-59122-7 corn. Proposed classification/Use: None.


  2. File Symbol: 68467-L. Applicant: Mycogen Seeds c/o Dow AgroSciences LLC, of Indianapolis, IN. Product Name: Mycogen Brand B.t. Cry34/35Ab1 Construct 17662 Corn. Plant-incorporated protectant. Active ingredient: Bacillus thuringiensis Cry34/35Ab1 insecticidal crystal protein and the genetic material for its production (plasmid insert PHP 17662) in event DAS-59122-7 corn. Proposed classification/Use: None.
8/31/04 Petition for Tolerance Exemption - EPA has received a pesticide petition (3F6785) from Mycogen Seeds c/o Dow AgroSciences LLC of Indianapolis, IN proposing to establish an exemption from the requirement of a tolerance for the plant-incorporated protectant Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for their production in corn.
3/10/04 Petition for Extension/Amendment of Experimental Use Permit - EPA has received applications 68467-EUP-7 and 29964-EUP-5 from Mycogen Seeds c/o Dow Agrosciences LLC and Pioneer Hi-Bred International requesting experimental use permit (EUP) amendment/extensions for Bacillus thuringiensis Cry34/35Ab1 protein and the genetic material necessary for its production (from the insert of plasmid PHP 17662) in corn.
1/06/04 Experimental Use Permit Issued - EPA has issued the following EUPs: 68467-EUP-7 to Mycogen Seeds c/o Dow AgroSciences LLC of Indianapolis, IN and 29964-EUP-5 to Pioneer Hi-Bred International, of Johnston, IA. These EUP allows the use of the plant-incorporated protectant Bacillus thuringiensis Cry34/35Ab1 proteins and the genetic material necessary for their production (from the insert of plasmid PHP17662) in corn on 624 acres of field corn to conduct insect resistance management, maize agronomic observation, maize breeding and observation nursery, maize demonstration, maize efficacy, maize hybrid production plots, maize regulatory field studies, non-target organism, and herbicide tolerance trials. The program is authorized only in the States of California, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Wisconsin, and the Commonwealth of Puerto Rico. These EUP is effective from June 24, 2003 to May 1, 2004. A tolerance has been established for residues of Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for their production in corn when used as plant-incorporated protectants in the food and feed commodities of field corn, sweet corn, and popcorn.

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2003
7/07/03 Temporary Tolerance Exemption Established - This regulation establishes a temporary exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for their production in corn on corn when applied/used as a plant- incorporated protectant. Mycogen Seeds c/o Dow AgroSciences LLC, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting the temporary tolerance exemption. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for their production in corn. The temporary tolerance exemption will expire on April 30, 2006.
3/13/03 Experimental Use Permit Applications - This notice announces receipt of applications 68467-EUP-3, 68467-EUP-5, 68467-EUP-T, 68467-EUP-I, 29964-EUP-1, 29964-EUP-3, 29964- EUP-U, and 29964-EUP-L from Mycogen Seeds/Dow Agrosciences LLC and Pioneer Hi-Bred International requesting experimental use permits (EUPs) and EUP amendments for
  1. Bacillus thuringiensis Cry34/35Ab1 protein and the genetic material necessary for its production (from the insert of plasmid PHP 14352) in corn,


  2. Bacillus thuringiensis Cry34/ 35Ab1 protein and the genetic material necessary for its production (from the insert of plasmid PHP 12560) in corn,


  3. Bacillus thuringiensis Cry34/35Ab1 protein and the genetic material necessary for its production (from the insert of plasmid PHP 17662) in corn, and<


  4. Bacillus thuringiensis Cry34/35Ab1 protein and the genetic material necessary for its production (from the insert of plasmid PHP 17658) in corn.
3/07/03 Petition for Temporary Tolerance Exemption - This notice of filing summarizes information submitted and cited by Mycogen/Dow AgroSciences in support of a request for a temporary exemption from tolerance residues of the plant-incorporated protectant Bacillus thuringiensis (B.t. Cry34/35Ab1 Insecticidal Crystal Protein (ICP), and the genetic material necessary for its production in corn.

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