Bacillus thuringiensis Cry3Bb1 Protein Federal Register Notices
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2005 |
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10/19/05 |
Conditional Approval of Active Ingredient EPA issued a notice, published in the Federal Register of March 13, 2002 ( 67 FR 11333 ) (FRL-6827-3), which announced that Monsanto Company of St. Louis, MO, had submitted an application to conditionally register the pesticide product, Event MON 863: Corn Rootworm Protected Corn (ZMIR13L), a plant-incorporated protectant (EPA File Symbol 524-LEI), containing Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (Vector ZMIR13L) in corn, an active ingredient not included in any previously registered product. The application was conditionally approved on February 24, 2003 for the product: Event MON 863, Corn Rootworm Protected Corn (ZMIR13L) (EPA Reg. No. 524-528) for use as a plant-incorporated protectant in corn. EPA issued a notice, published in the Federal Register of April 2, 2003 ( 68 FR 16036 ) (FRL-7286-1), which announced that Monsanto Company had submitted an application to conditionally register the pesticide product, YieldGard Plus Corn, a plant-incorporated protectant (EPA File Symbol 524-LUL), containing Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (Vector ZMIR13L) in corn and Bacillus thuringiensis Cry1A(b) delta endotoxin and the genetic material necessary for its production in corn via conventional breeding. The application was conditionally approved on October 25, 2003 for the product: YieldGard Plus Corn (EPA Registration Number 524-545) for use as a plant-incorporated protectant in corn. |
3/31/04 |
New Active Ingredient Conditional Approval - This notice announces Agency approval of an application submitted by Interregional Research Project Number 4 (IR-4), New Jersey Agricultural Experiment Station, Technology Center, on behalf of the Arizona Cotton Research and Protection Council to conditionally register the pesticide product Aspergillus flavus AF36 containing a new active ingredient not included in any previously registered products |
1/7/04 |
Experimental Use Permit Issued - EPA has issued the following EUP: 524-EUP-93 Amendment/extension to Monsanto Company of St. Louis, MO. This EUP allows the use of the plant-incorporated protectants MON863 x MON810 combined insecticidal trait stacked hybrids containing Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (vector ZMIR13L) in corn MON 863 and Bacillus thuringiensis Cry1Ab delta-endotoxin and the genetic material necessary for its production (vector PV-ZMCT01) in corn MON810 on 2,304 acres for breeding and observation nursery, inbred seed increase production, line per se and hybrid yield, insect efficacy, product characterization and performance/labeling, insect resistance management, non-target organism and benefit, and seed treatment trials. The program is authorized only in the States of Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, and Wisconsin. The EUP is effective from June 20, 2003 to December 31, 2003. Tolerance exemptions have been established for residues of the active ingredients in or on corn. |
10/22/03 |
Petition for Tolerance Exemption - EPA has received a pesticide petition request from Monsanto Company, 800 North Lindberg Blvd., St. Louis, Missouri 63167, proposing to amend 40 CFR part 180 by removing the time limitation for the exemption from the requirement of a tolerance for the plant-incorporated protectant Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production in corn in or on field corn, sweet corn, and popcorn. The tolerance exemption was originally requested under pesticide petition number PF 7F4888. |
4/23/03 |
Experimental Use Permit Amendment/Extension Application - This notice announces receipt of an application 52-EUP-93 from Monsanto Company requesting an amendment/extension of an experimental use permit (EUP) for the Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (vector ZMIR13L) in corn on 2,304 acres in various states for breeding and observation nursery, inbred seed increase production, line per se and hybrid yield, insect efficacy, product characterization and performance/labeling, insect resistance management, non-target organism and benefit, and seed treatment trials. |
4/2/03 |
Changed Use Pattern Registration Application - File symbol: 524-LUL. Applicant: Monsanto Company, 700 Chesterfield Parkway North, St. Louis, MO 63198. Product name: YieldGard Plus Corn. Product type: Plant-incorporated protectant insecticide. Active ingredients: Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (Vector ZMIR13L) in corn and Bacillus thuringiensis Cry1Ab protein and the genetic material necessary for its production in corn. Proposed classification/Use: None. YieldGard Plus Corn has claims for protection against leaf and stalk damage caused by lepidopteran insects and root damage caused by corn rootworms (Diabrotica spp.) The resulting hybrids were developed via conventional breeding techniques by crossing an inbred line of corn containing event MON 810 to an inbred line of corn containing event MON 863. |
6/26/02 |
Experimental Use Permits Granted - EPA has issued the following EUPs: 68467-EUP-4, 29964-EUP-2, and 524-EUP-93. Issuance, Amendment, and Amendment/Extension. Mycogen Seeds c/o Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268, Pioneer Hi-Bred International, Inc., 7250 NW 62\nd\ Avenue, Johnston, IA 5013, and Monsanto Company, 700 Chesterfield Parkway North, St. Louis, MO 63198. These EUPs allow the use of the plant-incorporated protectants Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production (from the insert of plasmid PHP 12537) in corn (moCry1F corn) and Bacillus thuringiensis Cry3Bb protein and the genetic material necessary for its production (vector ZMIR13L) in corn.
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5/1/02 |
Extension of Comment Period - In the Federal Register of 3/19/01 , EPA announced receipt of a seed increase registration application from Monsanto Company, 700 Chesterfield Parkway N., St. Louis, MO 63198 to register the product Event MON 863: Corn Rootworm Protected Corn (ZMIR13L) containing the plant-pesticide Bacillus thuringiensis Cry3Bb protein and the genetic material (Vector ZMIR13L) necessary for its production in corn. Monsanto subsequently modified their application for full commercial use and EPA announced receipt of the application on 3/19/01 . The original comment period ended on April 12, 2002. The comment period is being extended to May 31, 2002. Proposed Classification/Use: None. For full commercial use. |
3/13/02
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Application for New Active Ingredient - EPA received an application as follows to register a pesticide product containing active ingredients not included in any previously registered products. Notice of receipt of the application does not imply a decision by the Agency on the application. Product Containing Active Ingredients Not Included in Any Previously Registered Products. File symbol: 524-LEI. On 3/19/01 EPA announced receipt of a seed increase registration application from Monsanto Company (700 Chesterfield Parkway N., St. Louis, MO 63198) to register the product Event MON 863: Corn Rootworm Protected Corn (ZMIR13L) containing the plant-incorporated protectant Bacillus thuringiensis Cry3Bb protein and the genetic material (Vector ZMIR13L) necessary for its production in corn. Monsanto has subsequently modified their application for full commercial use. Proposed classification/Use: None. For full commercial use. |
2/20/02 |
Application for Experimental Use Permit Amendment - This notice announces receipt of an application from Monsanto Company to amend/extend their EUP number 524-EUP-93 for the plant-incorporated protectant Bacillus thuringiensis Cry3Bb protein and the genetic material necessary for its production (Vector ZMIR13L) in corn plants.(see the Federal Register of July 27, 2001) to allow for additional testing until February 28, 2003 on up to 9,400 acres in Alabama, Arkansas, California, Colorado, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, and Wisconsin. |
9/11/01 |
Experimental Use Permit Application - Monsanto Company has applied to amend their recently approved EUP 524-EUP-93 amendment/extension in order to allow livestock feeding studies and a lifting of the crop destruct provisions. The recently approved EUP published in the Federal Register on July 27, 2001. A tolerance exemption was established for Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production in corn on May 11, 2001. The tolerance exemption published in the Federal Register on May 11, 2001Experimental Use Permit Application - Monsanto Company has applied to amend their recently approved EUP 524-EUP-93 amendment/extension in order to allow livestock feeding studies and a lifting of the crop destruct provisions. The recently approved EUP published in the Federal Register on July 27, 2001. A tolerance exemption was established for Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production in corn on May 11, 2001. The tolerance exemption published in the Federal Register on May 11, 2001 |
7/27/01 |
Issuance of Experimental Use Permit Extension - EPA has issued the following EUP: 524-EUP-93. Amendment/Extension. Monsanto Company of, St. Louis, MO . This EUP allows the shipment of 7.4 pounds of the Cry3Bb protein insecticide in seeds shipped Bacillus thuringiensis Cry3Bb protein and the genetic material necessary for its production (Vector ZMIR13L) in corn plants on 4,000 acres of field corn |
5/11/01 |
Exemption from the Requirement of a Tolerance - This regulation establishes a time-limited exemption from the requirement of a tolerance for residues of the plant-pesticides Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production in corn on field corn, sweet corn, and popcorn and the plant-pesticides Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary for its production in corn on field corn, sweet corn, popcorn, or in cotton on cotton seed, cotton oil, cotton meal, cotton hay, cotton hulls, cotton forage, and cotton gin byproducts when applied/used as a plant-pesticide. |
3/19/01 |
Application for New Active Ingredient for Bacillus thuringiensis Cry3Bb protein and the genetic material (Vector ZMIR13L) necessary for its production in corn. From Monsanto Company of St. Louis, MO File symbol: 524-LEI. Proposed Classification/Use: None. For 1 year, contained, 22,875 acre pre-commercial inbred seed propagation and hybrid seed production registration. Plantings are proposed for the states of California, Hawaii, Illinois, Iowa, Indiana, Kansas, Michigan, Nebraska, South Dakota, Texas, and Wisconsin. |
1/17/01 |
Issuance of Experimental Use Permit - EPA has issued the following EUPs: 524-EUP-90, 524-EUP-92, and 524-EUP-93. to Monsanto Company, St. Louis, MO. The issuance of these EUPs allows the use of the plant-pesticides Bacillus thuringiensis Cry3Bb protein and the genetic material necessary for its production (vector ZMIR14L) in corn, Bacillus thuringiensis Cry3Bb protein and the genetic material necessary for its production (vector ZMIR12L) in corn, and Bacillus thuringiensis Cry3Bb protein and the genetic material necessary for its production (vector ZMIR13L) in corn, respectively |
12/28/00
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Application for New Experimental Use Permit Amendment - Monsanto Company has applied for an amendment of 524-EUP-93 for the plant-pesticide Bacillus thuringiensis Cry3Bb protein and the genetic material necessary for its production (Vector ZMIR13L) in corn plants to continue testing and evaluation from 2/1/2001 until 2/28/2002 |
12/8/99 |
Application for Experimental Use Permit. On December 8, 1999 EPA published a Federal Register Notice of the receipt from Monsanto Co. of St. Louis MO. of Experimental Use Permit Applications 524-EUP-ON, 524-EUP-OE, and 424-EUP-OG requesting experimental use permits (EUPs) for the Bacillus thuringiensis Cry3Bb protein and the genetic material necessary for its production (Vector ZMIR14L) in corn, the Bacillus thuringiensis Cry3Bb protein and the genetic material necessary for its production (Vector ZMIR12L) in corn, and the Bacillus thuringiensis Cry3Bb protein and the genetic material necessary for its production (Vector ZMIR13L) in corn. The Agency has determined that these applications may be of regional and national significance. Therefore, in accordance with 40 CFR 172.11(a), the Agency is soliciting comments on these applications. |