crop-chem-docs/corpus/epa_ppls/524-625.md

MON 89034 X MIR162

• EPA Reg No: 524-625
• Registrant: BAYER CROPSCIENCE, LLC
• Signal word: Caution
• 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%)
• Label accepted: 2026-08-17
• Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00625-20260817.pdf

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August 17, 2026

Edwards Allen, Ph.D. Global Regulatory Manager Bayer CropScience LLC 700 Chesterfield Parkway West Chesterfield, MO 63017

Subject: PRIA (Pesticide Registration Improvement Act) B900 Amendments – Addition of time-limited refuge requirement for southwestern corn borer management in specified areas of New Mexico and Arizona and associated label updates. Product Names: See Table 1 below. EPA Registration Numbers: See Table 1 below. EPA Receipt Date: July 07, 2026 OPP Case Numbers: See Table 1 below.

Dear Dr. Allen:

The amendments referenced above and described below, submitted in connection with registration under Section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), are acceptable. The following products are subject to these amendments:

Table 1. List of Amended Products Product Name EPA Registration No. OPP Action Case No. Lepidopteran Active Toxins MON 89034 x MIR162 524-625 00702260 Cry1A.105, Cry2Ab2, Vip3Aa20 MON 89034 x MIR162 x MON 87411 524-635 00702259 Cry1A.105, Cry2Ab2, Vip3Aa20, Cry3Bb1, DvSnf7

For each of the products listed in Table 1, the refuge requirements are modified as follows:

x Growers in Hidalgo Co., NM (near Antelope Wells and Animas) and Cochise Valley in Arizona (Cochise Co. south of Graham Co., AZ) are not required to plant a non-Bt refuge for the 2027 and 2028 growing seasons.

This approval does not affect any of the other terms or conditions that were previously imposed on these registrations. You continue to be subject to existing terms or conditions on your registrations and any deadlines connected with them, as described in EPA’s Registration

Page 2 of 2 EPA Registration Nos. 524-625 and 524-635 Action Case Nos. 00702260 and 00702259

Notices for these products.

Should you wish to add/retain a reference to your company’s website on your label(s), then please be aware that the website becomes labeling under FIFRA and is subject to review by the U.S. Environmental Protection Agency (EPA). If the website is false or misleading, the product(s) will be considered to be misbranded and sale or distribution of the product is unlawful under FIFRA section 12(a)(1)(E). 40 CFR § 156.10(a)(5) lists examples of statements EPA may consider false or misleading. In addition, regardless of whether a website is referenced on your product’s label, claims made on the website may not substantially differ from those claims approved through the registration process. Therefore, should EPA find or if it is brought to our attention that a website contains statements or claims substantially differing from statements or claims made in connection with obtaining a FIFRA section 3 registration, the website will be referred to EPA’s Office of Enforcement and Compliance Assurance.

Stamped copies of your labels are enclosed for your records. This labeling supersedes all previously accepted labeling. In accordance with 40 CFR § 152.130(c), you may distribute or sell this product under the previously approved labeling for 18 months from the date of this letter. After 18 months, you may only distribute or sell this product if it bears this new revised labeling or subsequently approved labeling. “To distribute or sell” is defined under FIFRA section 2(gg) and its implementing regulation at 40 § CFR 152.3.

Your release for shipment of these products constitutes acceptance of these terms. If these terms are not complied with, these registrations will be subject to cancellation in accordance with FIFRA section 6.

The following approved Confidential Statements of Formula (CSF) are on file for your products:

x 524-625: Basic CSF Dated April 1, 2020 x 524-635: Basic CSF Dated May 10, 2016

If you have any questions, please contact David Linz by email at [email protected] or by phone at (513) 569-7538.

Sincerely,

Alan Reynolds, Product Manager 94 Emerging Technologies Branch Biopesticides and Pollution Prevention Division (7511M) Office of Pesticide Programs

Enclosures: Product Label Stamped “Acceptable” Digitally signed by ALAN REYNOLDS Date: 2026.08.17 13:43:45 -04'00'

Plant-Incorporated Protectant Label MON 89034 × MIR162 (OECD Unique Identifier: MON-89Ø34-3 × SYN-IR162-4) Active Ingredients: Bacillus thuringiensis Cry1A.105 protein and the genetic material (vector PV-ZMIR245) necessary for its production in event MON 89034 × MIR162 corn (OECD Unique ,GHQWLILHU 021‘ î 6<1,5 ” Bacillus thuringiensis Cry2Ab2 protein and the genetic material (vector PV-ZMIR245) necessary for its production in MON 89034 × MIR162 corn (OECD Unique Identifier: 021‘ î 6<1,5 ” Bacillus thuringiensis Vip3Aa20 protein and the gene tic material (vector pNOV1300) necessary for its production in MON 89034 × MIR162 corn (OECD Unique Identifier: 021‘ î 6<1,5  ” Other Ingredients: Phosphomannose isomerase (PMI) marker protein and the genetic material (vector pNOV1300) necessary for its production in MON 89034 × MIR162 corn (OECD Unique ,GHQWLILHU 021‘ î 6<1,5  ” *Percentage (wt/wt) on a dry weight basis for whole plant (forage). KEEP OUT OF REACH OF CHILDREN CAUTION NET CONTENTS__________ EPA Registration No. 524-625 EPA Establishment No. 524-MO-002 Bayer CropScience LLC 800 North Lindbergh Blvd. St Louis, MO 63167 08/17/2026 524-625

DIRECTIONS FOR USE It is a violation of Federal law to use this product in any manner inconsistent with its labeling. Information regarding co mmercial production reflected here and, in the terms, and conditions of this registration must be included in the Technology Use Guide. MON 89034 × MIR162 protects corn crops from leaf, stalk, and ear damage caused by lepidopteran corn pests listed on this label. In order to minimize the risk of these pests developing resistance to MON 89034 × MIR162, an insect resistance management (IRM) plan must be implemented which includes planting of a structured refuge. This plant-incorporated protectant (PIP ) may be combined or produced through conventional breeding with other registered PIPs that are si milarly approved for use in combination, through conventional breeding, with other registered PIPs. These refuge requirements do not apply to planting of inbred/hybrid corn seed productions, breeding, and small-sc ale research trials on up to a total of 20,000 acres per county and up to a combined United States (U.S.) total of 250,000 ac res per PIP active ingredient per registrant per year. Growers in Hidalgo Co, NM (near Antelope Wells and Animas) and Cochise Valley in Arizona (Cochise Co. South of Graham Co, AZ) are not required to plant a non-Bt refuge for the 2027 and 2028 growing seasons. Several options for deployment of the re fuge for MON 89034 × MIR162 are available to growers. These options are based on the planting of MON 89034 × MIR162 in cotton or non-cotton growing regions and the insect pres sure present in those locations. The refuge sizes for these regions are ei ther 5% (i.e., 5 acres of non-PIP corn for every 95 acres MON 89034 × MIR162 corn planted) or 20% (20 acres of non-PIP corn for every 80 acres of MON 89034 × MIR162 corn planted). a) Corn-Belt/Non-Cotton-Growing Area Refuge Requirements For MON 89034 × MIR162 field corn grown outside cotton-growing areas (e.g., the Corn Belt), grower guides must sp ecify that growers must adhe re to the following refuge requirements. Growers must plant a structured refuge of at least 5% corn, which is not a lepidopteran- protected Bt corn hybrid. The refu ge may be treated with inse cticides, as detailed below, to control lepidopteran stalk-boring and other pests. Insecticide treatments for pest s listed on this label may be applied only if economic thresholds are reached for one or more of th ese target pests. Economic thresholds will be determined using methods recommended by local or re gional professionals (e.g.,

Extension Service agents or crop consultants ). Instructions to growers will specify that microbial Bt insecticides must not be applied to non-B.t. corn refuges. Refuge planting options include: separate fields, blocks within fields (e.g., along the edges or headlands), perimeter strips, and strips across the field. External refuges must be planted within ½ mile. When planting the refuge in stri ps across the field, refuges mu st be at least 4 consecutive rows wide. b) Cotton-Growing Area Refuge Requirements Cotton-growing areas include the following stat es: Alabama, Arkansas, Georgia, Florida, Louisiana, North Carolina, Mississippi, Sout h Carolina, Oklahoma (only the counties of Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, and Washita), Tennessee (only the counties of Carroll, Chester, Crockett, Dyer, Fayette, Franklin, Gibson, Hardeman, Hardin, Hayw ood, Lake, Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby, and Tipton), Texas (except the counties of Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, Moor e, Ochiltree, Roberts, and Sherman), Virginia (only the counties of Dinwiddie, F ranklin City, Greensville, Isle of Wight, Northampton, Southampton, Suffolk City, Surrey, Sussex) and Missouri (only the counties of Dunklin, New Madrid, Pemiscot, Scott, Stoddard). For MON 89034 × MIR162 field corn grown in cotton-growing areas, grower guides must specify that growers must adhere to the following refuge requirements. MON 89034 x MIR162 (95 acres) ”½ mile Refuge Non-Bt Lepidopteran- protected corn (5 acres) MON 89034 x MIR162 (95 acres) Refuge Non-Bt Lepidopteran- protected corn (5 acres)

Growers must plant a structured refuge of at least 20% cor n, which is not a lepidopteran- protected Bt corn hybrid. The refu ge may be treated with insect icides, as detailed below, to control lepidopteran stalk-boring and other pests. Insecticide treatments for pest s listed on this label may be applied only if economic thresholds are reached for one or more of thes e target pests. Economic thresholds will be determined using methods recommended by local or re gional professionals (e.g., Extension Service agents, crop consultants). Instructions to growers will specify that microbial Bt insecticides must not be applied to non-Bt corn refuges. Refuge planting options include : separate fields, blocks within fields (e.g., along the edges or headlands), perimeter strips, and strips across the field. External refuges must be planted within ½ mile. When planting the refuge in stri ps across the field, refuges mu st be at least 4 consecutive rows wide. MON 89034 x MIR162 (80 acres) ”½ mile Refuge Non-Bt lepidopteran- protected corn (20 acres) MON 89034 x MIR162 (80 acres) Refuge Non-Bt lepidopteran- protected corn (20 acres)

Corn Insects Controlled or Suppressed European corn borer Ostrinia nubilalis Southwestern corn borer Diatraea grandiosella Southern cornstalk borer Diatraea crambidoides Corn earworm Helicoverpa zea Fall armyworm Spodoptera frugiperda Stalk borer Papaipema nebris Sugarcane borer Diatraea saccharalis Beet armyworm Spodoptera exigua True armyworm Pseudelatia unipuncta Black cutworm Agrotis ipsilon Western bean cutworm Striacosta albicosta Lesser cornstalk borer Elasmopalpus lignosellus Dingy Cutworm Feltia jaculifera Sales of corn hybrids that contain Bayer’s Bt corn plant incorporated protectant must be accompanied by a Grower Guide which includes information on planting, production and insect resistance management and notes that routine applications of insecticides to control these insects are usually unnecessary when corn containing the Bt proteins is planted.

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MON 89034 × MIR162 is a product of Bayer’s research program offering unique genetic characteristics for specific grower needs and may be protected by one or mo re of the following U.S. patents that can be found at http://cs.bayerpatents.bayer.com