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258 lines
13 KiB
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258 lines
13 KiB
Markdown
# MON 89034 X MIR162
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- EPA Reg No: **524-625**
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- Registrant: BAYER CROPSCIENCE, LLC
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- Signal word: Caution
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- Active ingredients: Bacillus thuringiensis Cry1A.105 protein and genetic material necessary (vector PV-ZMIR245) for its production in corn (0.0059%); Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary (vector PV-ZMIR245) for its production in corn (0.0043%); Bacillus thuringiensis Vip3Aa20 protein encoded by vector pNOV1300 in event MIR162 corn (SYN-IR162-4), % dw (0.015%)
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- Label accepted: 2026-08-17
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- Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00625-20260817.pdf
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---
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August 17, 2026
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Edwards Allen, Ph.D.
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Global Regulatory Manager
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Bayer CropScience LLC
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700 Chesterfield Parkway West
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Chesterfield, MO 63017
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Subject:
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PRIA (Pesticide Registration Improvement Act) B900 Amendments – Addition of
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time-limited refuge requirement for southwestern corn borer management in
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specified areas of New Mexico and Arizona and associated label updates.
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Product Names: See Table 1 below.
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EPA Registration Numbers: See Table 1 below.
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EPA Receipt Date: July 07, 2026
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OPP Case Numbers: See Table 1 below.
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Dear Dr. Allen:
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The amendments referenced above and described below, submitted in connection with
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registration under Section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act
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(FIFRA), are acceptable. The following products are subject to these amendments:
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Table 1. List of Amended Products
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Product Name EPA
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Registration
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No.
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OPP Action Case
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No.
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Lepidopteran Active Toxins
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MON 89034 x MIR162 524-625 00702260 Cry1A.105, Cry2Ab2,
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Vip3Aa20
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MON 89034 x MIR162
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x MON 87411
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524-635 00702259 Cry1A.105, Cry2Ab2,
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Vip3Aa20, Cry3Bb1, DvSnf7
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For each of the products listed in Table 1, the refuge requirements are modified as follows:
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x Growers in Hidalgo Co., NM (near Antelope Wells and Animas) and Cochise Valley in
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Arizona (Cochise Co. south of Graham Co., AZ) are not required to plant a non-Bt refuge
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for the 2027 and 2028 growing seasons.
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This approval does not affect any of the other terms or conditions that were previously
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imposed on these registrations. You continue to be subject to existing terms or conditions on
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your registrations and any deadlines connected with them, as described in EPA’s Registration
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Page 2 of 2
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EPA Registration Nos. 524-625 and 524-635
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Action Case Nos. 00702260 and 00702259
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Notices for these products.
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Should you wish to add/retain a reference to your company’s website on your label(s), then
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please be aware that the website becomes labeling under FIFRA and is subject to review by the
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U.S. Environmental Protection Agency (EPA). If the website is false or misleading, the product(s)
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will be considered to be misbranded and sale or distribution of the product is unlawful under
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FIFRA section 12(a)(1)(E). 40 CFR § 156.10(a)(5) lists examples of statements EPA may consider
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false or misleading. In addition, regardless of whether a website is referenced on your product’s
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label, claims made on the website may not substantially differ from those claims approved
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through the registration process. Therefore, should EPA find or if it is brought to our attention
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that a website contains statements or claims substantially differing from statements or claims
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made in connection with obtaining a FIFRA section 3 registration, the website will be referred
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to EPA’s Office of Enforcement and Compliance Assurance.
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Stamped copies of your labels are enclosed for your records. This labeling supersedes all
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previously accepted labeling. In accordance with 40 CFR § 152.130(c), you may distribute or sell
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this product under the previously approved labeling for 18 months from the date of this letter.
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After 18 months, you may only distribute or sell this product if it bears this new revised labeling
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or subsequently approved labeling. “To distribute or sell” is defined under FIFRA section 2(gg)
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and its implementing regulation at 40 § CFR 152.3.
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Your release for shipment of these products constitutes acceptance of these terms. If these
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terms are not complied with, these registrations will be subject to cancellation in accordance
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with FIFRA section 6.
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The following approved Confidential Statements of Formula (CSF) are on file for your products:
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x 524-625: Basic CSF Dated April 1, 2020
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x 524-635: Basic CSF Dated May 10, 2016
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If you have any questions, please contact David Linz by email at linz.david@epa.gov or by
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phone at (513) 569-7538.
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Sincerely,
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Alan Reynolds, Product Manager 94
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Emerging Technologies Branch
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Biopesticides and Pollution
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Prevention Division (7511M)
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Office of Pesticide Programs
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Enclosures: Product Label Stamped “Acceptable”
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Digitally signed by
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ALAN REYNOLDS
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Date: 2026.08.17
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13:43:45 -04'00'
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Plant-Incorporated Protectant Label
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MON 89034 × MIR162
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(OECD Unique Identifier: MON-89Ø34-3 × SYN-IR162-4)
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Active Ingredients:
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Bacillus thuringiensis Cry1A.105 protein and the genetic material (vector PV-ZMIR245)
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necessary for its production in event MON 89034 × MIR162 corn (OECD Unique
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,GHQWLILHU 021 î 6<1,5
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Bacillus thuringiensis Cry2Ab2 protein and the genetic material (vector PV-ZMIR245)
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necessary for its production in MON 89034 × MIR162 corn (OECD Unique Identifier:
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021 î 6<1,5
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Bacillus thuringiensis Vip3Aa20 protein and the gene tic material (vector pNOV1300)
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necessary for its production in MON 89034 × MIR162 corn (OECD Unique Identifier:
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021 î 6<1,5
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Other Ingredients:
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Phosphomannose isomerase (PMI) marker protein and the genetic material (vector
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pNOV1300) necessary for its production in MON 89034 × MIR162 corn (OECD Unique
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,GHQWLILHU 021 î 6<1,5
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*Percentage (wt/wt) on a dry weight basis for whole plant (forage).
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KEEP OUT OF REACH OF CHILDREN
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CAUTION
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NET CONTENTS__________
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EPA Registration No. 524-625
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EPA Establishment No. 524-MO-002
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Bayer CropScience LLC
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800 North Lindbergh Blvd.
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St Louis, MO 63167
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08/17/2026
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524-625
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DIRECTIONS FOR USE
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It is a violation of Federal law to use this product in any manner inconsistent with its
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labeling. Information regarding co mmercial production reflected here and, in the terms,
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and conditions of this registration must be included in the Technology Use Guide.
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MON 89034 × MIR162 protects corn crops from leaf, stalk, and ear damage caused by
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lepidopteran corn pests listed on this label. In order to minimize the risk of these pests
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developing resistance to MON 89034 × MIR162, an insect resistance management (IRM)
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plan must be implemented which includes planting of a structured refuge.
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This plant-incorporated protectant (PIP ) may be combined or produced through
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conventional breeding with other registered PIPs that are si milarly approved for use in
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combination, through conventional breeding, with other registered PIPs.
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These refuge requirements do not apply to planting of inbred/hybrid corn seed
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productions, breeding, and small-sc ale research trials on up to a total of 20,000 acres per
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county and up to a combined United States (U.S.) total of 250,000 ac res per PIP active
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ingredient per registrant per year.
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Growers in Hidalgo Co, NM (near Antelope Wells and Animas) and Cochise Valley in
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Arizona (Cochise Co. South of Graham Co, AZ) are not required to plant a non-Bt refuge
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for the 2027 and 2028 growing seasons.
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Several options for deployment of the re fuge for MON 89034 × MIR162 are available to
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growers. These options are based on the planting of MON 89034 × MIR162 in cotton or
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non-cotton growing regions and the insect pres sure present in those locations. The refuge
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sizes for these regions are ei ther 5% (i.e., 5 acres of non-PIP corn for every 95 acres
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MON 89034 × MIR162 corn planted) or 20% (20 acres of non-PIP corn for every 80
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acres of MON 89034 × MIR162 corn planted).
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a) Corn-Belt/Non-Cotton-Growing Area Refuge Requirements
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For MON 89034 × MIR162 field corn grown outside cotton-growing areas (e.g., the Corn
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Belt), grower guides must sp ecify that growers must adhe re to the following refuge
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requirements.
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Growers must plant a structured refuge of at least 5% corn, which is not a lepidopteran-
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protected Bt corn hybrid. The refu ge may be treated with inse cticides, as detailed below,
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to control lepidopteran stalk-boring and other pests.
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Insecticide treatments for pest s listed on this label may be applied only if economic
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thresholds are reached for one or more of th ese target pests. Economic thresholds will be
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determined using methods recommended by local or re gional professionals (e.g.,
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Extension Service agents or crop consultants ). Instructions to growers will specify that
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microbial Bt insecticides must not be applied to non-B.t. corn refuges.
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Refuge planting options include: separate fields, blocks within fields (e.g., along the
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edges or headlands), perimeter strips, and strips across the field.
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External refuges must be planted within ½ mile.
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When planting the refuge in stri ps across the field, refuges mu st be at least 4 consecutive
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rows wide.
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b) Cotton-Growing Area Refuge Requirements
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Cotton-growing areas include the following stat es: Alabama, Arkansas, Georgia, Florida,
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Louisiana, North Carolina, Mississippi, Sout h Carolina, Oklahoma (only the counties of
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Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, and
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Washita), Tennessee (only the counties of Carroll, Chester, Crockett, Dyer, Fayette,
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Franklin, Gibson, Hardeman, Hardin, Hayw ood, Lake, Lauderdale, Lincoln, Madison,
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Obion, Rutherford, Shelby, and Tipton), Texas (except the counties of Carson, Dallam,
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Hansford, Hartley, Hutchinson, Lipscomb, Moor e, Ochiltree, Roberts, and Sherman),
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Virginia (only the counties of Dinwiddie, F ranklin City, Greensville, Isle of Wight,
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Northampton, Southampton, Suffolk City, Surrey, Sussex) and Missouri (only the
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counties of Dunklin, New Madrid, Pemiscot, Scott, Stoddard).
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For MON 89034 × MIR162 field corn grown in cotton-growing areas, grower guides
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must specify that growers must adhere to the following refuge requirements.
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MON 89034 x MIR162
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(95 acres) ½ mile
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Refuge
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Non-Bt Lepidopteran-
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protected corn
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(5 acres)
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MON 89034 x MIR162
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(95 acres)
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Refuge
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Non-Bt Lepidopteran-
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protected corn
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(5 acres)
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Growers must plant a structured refuge of at least 20% cor n, which is not a lepidopteran-
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protected Bt corn hybrid. The refu ge may be treated with insect icides, as detailed below,
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to control lepidopteran stalk-boring and other pests.
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Insecticide treatments for pest s listed on this label may be applied only if economic
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thresholds are reached for one or more of thes e target pests. Economic thresholds will be
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determined using methods recommended by local or re gional professionals (e.g.,
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Extension Service agents, crop consultants). Instructions to growers will specify that
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microbial Bt insecticides must not be applied to non-Bt corn refuges.
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Refuge planting options include : separate fields, blocks within fields (e.g., along the
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edges or headlands), perimeter strips, and strips across the field.
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External refuges must be planted within ½ mile.
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When planting the refuge in stri ps across the field, refuges mu st be at least 4 consecutive
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rows wide.
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MON 89034 x MIR162
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(80 acres) ½ mile
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Refuge
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Non-Bt lepidopteran-
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protected corn
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(20 acres)
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MON 89034 x MIR162
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(80 acres)
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Refuge
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Non-Bt lepidopteran-
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protected corn
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(20 acres)
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Corn Insects Controlled or Suppressed
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European corn borer Ostrinia nubilalis
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Southwestern corn borer Diatraea grandiosella
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Southern cornstalk borer Diatraea crambidoides
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Corn earworm Helicoverpa zea
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Fall armyworm Spodoptera frugiperda
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Stalk borer Papaipema nebris
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Sugarcane borer Diatraea saccharalis
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Beet armyworm Spodoptera exigua
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True armyworm Pseudelatia unipuncta
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Black cutworm Agrotis ipsilon
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Western bean cutworm Striacosta albicosta
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Lesser cornstalk borer Elasmopalpus lignosellus
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Dingy Cutworm Feltia jaculifera
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Sales of corn hybrids that contain Bayer’s Bt corn plant incorporated protectant must be
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accompanied by a Grower Guide which includes information on planting, production and
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insect resistance management and notes that routine applications of insecticides to control
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these insects are usually unnecessary when corn containing the Bt proteins is planted.
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__________________________
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MON 89034 × MIR162 is a product of Bayer’s research program offering unique genetic characteristics for
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specific grower needs and may be protected by one or mo re of the following U.S. patents that can be found
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at http://cs.bayerpatents.bayer.com
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