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Bacillus thuringiensis Cry3Bb1 Protein and the Genetic Material Necessary for its Production (Vector ZMIR13L) in Event MON 863 Corn & Bacillus thuringiensis Cry1Ab Delta-Endotoxin and the Genetic Material Necessary for its Production in Corn (006430, 006484) 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 |
Tolerance Exemption Established - This regulation establishes an exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production in corn on field corn, sweet corn, and popcorn when applied/used as a plant- incorporated protectant. Monsanto Company of St. Louis, Missouri 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 Cry3Bb1 protein and the genetic material necessary for its production in corn. |
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. |
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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| 2/20/02 | Application for Experimental Use Permit Amendment - This notice announces receipt of an application fromMonsanto 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, 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. |
| 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 | 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 |