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Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production (plasmid insert PHI8999) in corn plants (006481) Federal Register Notices

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Bacillus thuringiensis subsp. kurstaki (B.t.k.) cryIA(c) protein segment (006445)
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2005
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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2003
4/30/03 Temporary Tolerance Exemption Established - This regulation establishes a temporary exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Cry1F protein in cotton 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 requesting the temporary/tolerance exemption. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus thuringiensis Cry1F protein in cotton. The temporary tolerance exemption will expire on May 1, 2004.

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2002
12/11/02 New Experimental Use Permit - This notice announces receipt of an application 68467-EUP-A from Dow AgroSciences requesting an experimental use permit (EUP) for the plant incorporated-protectant Bacillus thuringiensis Cry1F and Cry1Ac in cotton. The requested number of acres for this plant incorporated- protectant is 2,826. The EUP is for the states of Alabama, Arizona, Arkansas, California, Florida, Georgia, Louisiana, Mississippi, Missouri, New Mexico, North Carolina, Puerto Rico, South Carolina, Tennessee, and Texas. Test plants will consist of cotton.

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2001
9/6/01 Experimental Use Permit Granted - EPA has issued the following EUP:  68467-EUP-2. Amendment. Mycogen Seeds c/o Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054. The EUP amendment/extension for Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production (Plasmid Insert PHI8999) in corn plants was published in the Federal Register of January 17, 2001 . This subsequent amendment allowed 55 acres from the Nebraska approved total to be planted in Puerto Rico. The transfer reduced the state acreage in Nebraska from 161.96 to 106.96 acres and increased the state acreage in Puerto Rico from 34 to 89 acres. This permit was issued with the limitation that all treated crops be destroyed or used for research purposes only.
9/5/01 Extension of Comment Period  In the July 17, 2001 Federal Register (66 FR 37227) (FRL-6793-6), the Agency announced the July 24, 2001 Technical Briefing and an opportunity to comment on the Bt Crops reassessment. EPA asked that comments be submitted by August 30, 2001. In the August 10, 2001 Federal Register (66 FR 42220) (FRL-6791-4), the Agency announced the registration of the Cry1F corn plant-incorporated protectant and the opening of a public docket containing the record on which EPA based this registration. Several members of the public have asked for additional time to submit comments in response to the July 17 Notice. In addition, some members of the public have asked for additional time to comment on the Cry1F product and have asked that it be considered separately from the other products covered by the Bt Crops Reassessment. Although the notice of registration and materials in the public docket for Cry1F state that the Cry1F product would be reevaluated on the same schedule as other Bt corn products and that relevant decisions in the Bt Crops Reassessment would be applied to that registration, this information was not noted in the FR Notice. Thus, this notice clarifies that the Cry1F product is included within the scope of the Bt Crops Reassessment. Further, in light of all of the circumstances, this Notice also announces the Agency's decision to provide additional time to comment for all Bt corn and cotton products with expiring registrations.

Several members of the public have also asked in a letter dated July 23, 2001, for an extension because a portion of the data base for the Bt Crops Reassessment relating to the toxicity of Bt corn pollen to Monarch butterflies is not publicly available. While these data are still subject to a confidentiality claim that prevents public release at this time, EPA has arranged to allow the public to inspect these data in EPA reading rooms, provided that any person inspecting the data first signs a Confidentiality Agreement. See https://www.epa.gov/pesticides/biopesticides for more information.

In summary, the Agency is extending until September 10, 2001, the period for comment on the implications of the revised risk and benefit sections of the reassessment, the draft Potential Risk Mitigation and Regulatory Options paper, and the regulatory decisions on the Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production (plasmid insert PHI8999) in corn plants.
8/10/01 New Active Ingredient Conditional Registration
  1. EPA Registration No.: 68467-2. Registrant: Mycogen Seeds of Indianapolis, IN. Product name: Herculex I Insect Protection. Active ingredient: Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production (plasmid insert PHI8999) in corn plants. For full commercial use.
  2. File Symbol: 29964-G. Applicant: Pioneer Hi-Bred International, Inc., of Johnston, Iowa .Product name: Pioneer Brand Seed Corn with Herculex I. Active ingredient: Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production (plasmid insert PHI8999) in corn plants. For full commercial use.
6/6/01 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 Cry1F protein and the genetic material necessary for its production in corn on field corn, sweet corn, and popcorn when applied/used as a plant-pesticide. Mycogen Seeds c/o Dow AgroSciences LLC submitted a petition to EPA requesting an exemption from the requirement of a tolerance.
3/27/01 Application for New Experimental Use Permits Mycogen Seeds c/o Dow AgroSciences, of Indianapolis, IN,  and Pioneer Hi-Bred International have requested to amend and extend an EUP (68467-EUP-2) for the plant-pesticide Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production (plasmid insert PHI 8999) in corn. Mycogen Seeds has requested to test 19,363 acres.  Acreage is requested for maize breeding and observation nursery, maize academic efficacy trials, maize agronomic observation trials, maize efficacy trial, maize production research trials, maize demonstration trials, herbicide tolerance study, insect resistance management studies, seed production research, and grain production for feeding trials. The EUP is to be genetically contained. Corn grown during the EUP is not to be used for food or feed, unless the pending temporary tolerance petition (OG6112) is granted and the EUP is amended to allow food use. The pending temporary tolerance petition (OG6112) published in the Federal Register on 6/15/00
1/17/01 Issuance of Experimental Use Permit - EPA has issued the following EUP Extensions/Amendments: 68467-EUP-2.  Mycogen Seeds c/o Dow AgroSciences LLC,  Indianapolis, IN 46268. The amendments and extensions to this EUP allow the use of the plant- pesticide Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production (plasmid insert PHI8999) in corn plants.

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2000
12/15/00 Application for Experimental Use Permit Amendment. - Mycogen Seeds c/o Dow AgroSciences LLC is requesting to amend 68467-EUP-2 for the plant-pesticide Bacillus thuringiensis delta endotoxin as produced in corn by a Cry1F gene and its controlling sequences as found on plasmid insert PHI8999. This amendment request entails the transfer of 55 acres in Nebraska to Puerto Rico.
6/22/00 Extension of Comment Period for Registration Application This notice extends the comment period of the Agency's May 5, 2000 notice announcing receipt of an application to register a pesticide product containing a new active ingredient [Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production (plasmid insert PHI8999) in corn plants] not included in any previously registered product pursuant to the provisions of section 3(c)(4) of FIFRA
6/15/00 Tolerance Exemption Proposal(0G6112) for Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production in plants in or on all food commodities. From Mycogen Seeds c/o Dow AgroSciences LLC of Indianapolis, IN
5/5/00 Application for New Active Ingredient for Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production (plasmid insert PHI8999) in corn plants - for full commercial use.  - (68467-E) by Mycogen Seeds of Indianapolis IN  [Note: This amends the 11/26/99 FR Notice]  [Note: comment period extended in 6/22/00 FR Notice.]
5/5/00 Application for New Active Ingredient for Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production (plasmid insert PHI8999) in corn plants - for full commercial use.  (29964-G) - by Pioneer Hi-Bred International of Johnston IA [Note: This amends the 11/26/99 FR Notice]  [Note: comment period extended in 6/22/00 FR Notice.]
3/3/00 Application for Experimental Use Permit Amendment. EPA has received an application from Mycogen c/o Dow Agrosciences LLC,  Indianapolis, IN , for an extension/amendment of their EUP for Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production (plasmid insert PHI8999) in corn plants (68467-EUP-2). Notice of the original issuance of this EUP was published in the Federal Register on 5/5/99 (64 FR 24161) (FRL-6078-2). The new program extends testing to March 31, 2001 and adds 2,240 acres. Field testing is to take place in: Hawaii, Illinois, Indiana, Iowa, Minnesota, Nebraska, and Puerto Rico. Experimental trials are to involve agronomic observation and model validation for pollen shed phenology.
3/2/00 Petition for Tolerance Exemption - EPA has received a pesticide petition (0F6078) from Mycogen Seeds c/o Dow AgroSciences LLC,  Indianapolis, IN  proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for the plant-pesticide Bacillus thuringiensis subspecies aizawai Cry1F protein and the genetic material necessary for its production in plants in or on all food commodities.
2/25/00 Application for Experimental Use Permit. On February 9, 2000 EPA published a Federal Register Notice of the receipt of an application 68467-EUP-2 from Mycogen c/o Dow Agrosciences LLC requesting an experimental use permit (EUP) for the Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production (plasmid insert PHI8999) in corn plants. The Agency has determined that the application may be of regional and national significance. Therefore, in accordance with 40 CFR 172.11(a), the Agency is soliciting comments on this application.

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1999
11/26/99 Application for New Active Ingredient for Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production (plasmid insert PHI8999) in corn plants - for seed increase registration for a total of 5,000 acres per year in Illinois, Iowa, Indiana, Nebraska, Minnesota, Texas, Hawaii, and Puerto Rico  - (68467-E) by Mycogen Seeds of Indianapolis IN   [Note: Amended by 5/5/00 FR Notice.
11/26/99 Application for New Active Ingredient for Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production (plasmid insert PHI8999) in corn plants - for seed increase registration for a total of 620 acres per year in Hawaii  (29964-G) - by Pioneer Hi-Bred International of Johnston IA   [Note: Amended by 5/5/00 FR Notice.
5/5/99 Experimental Use Permit Granted for Bacillus thuringiensis delta endotoxin as produced in corn by a Cry1F gene and its controlling sequences as found on plasmid insert PHI8999 to evaluate control of various insect pests of the corn.  The permit authorizes use in 13 states and Puerto Rico (68467-EUP-2) from Mycogen Plant sciences, Mycogen Corporation of San Diego, CA
2/10/99 Application for Experimental Use Permit for Bacillus thuringiensis delta endotoxin as produced in corn by a cry1F gene and its controlling sequences as found on plasmid insert PHI8999 (68467-EUP-E) to control European Corn Borer - from Mycogen Corp. of San Diego, CA

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