crop-chem-docs/corpus/epa_ppls/524-635.md

MON 89034 X MIR162 X MON 87411 INSECT-PROTECTED, HERBICIDE-TOLERANT CORN

• EPA Reg No: 524-635
• 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 (0.0027%); Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary (vector PV-ZMIR245) for its production in corn (0.0071%); dsRNA transcript comprising a DvSnf7 inverted repeat sequence derived from western corn rootworm (Diabrotica virgifera) and the genetic material necessary for its production MON 87411 corn (3.7e-07%); Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its procuction (vector PV -ZMIR10871) in corn event MON 87411 (0.0086%); Bacillus thuringiensis Vip3Aa20 protein encoded by vector pNOV1300 in event MIR162 corn (SYN-IR162-4), % dw (0.014%)
• Label accepted: 2026-08-17
• Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00635-20260817.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 × MON 87411 (OECD Unique Identifier: MON-89Ø34-3 × SYN-IR162-4 × MON-87411-9) Active Ingredients: Bacillus thuringiensis Cry1A.105 protein and the geneti c material necessary for its production (vector PV-ZMIR245) in even t MON 89034 corn (Unique Identifier MON- ‘  ” Bacillus thuringiensis Cry2Ab2 protein and the geneti c material necessary for its production (vector PV-ZMIR245) in even t MON 89034 corn (Unique Identifier MON- ‘  ” Bacillus thuringiensis Vip3Aa20 protein and the gene tic material necessary for its production (vector pNOV1300) in event MIR162 corn (Unique Identifier SYN-IR162-4))  ” Bacillus thuringiensis Cry3Bb1 protein and the genetic material (vector PV-ZMIR10871) necessary for its production in corn even t MON 87411 (OECD Unique Identifier: MON- «««««««««««««««««««««««««« «”  dsRNA transcript comprising a DvSnf7 inverted repeat sequence derived from Diabrotica virgifera virgifera , and the genetic material necess ary for its production (vector PV- ZMIR10871) in MON 87411 corn (OECD Unique Identifier MON-87411- ««««««««««««««««««««««««««««”  Other Ingredients: Phosphomannose isomerase (PMI ) marker protein and the ge netic material necessary YHFWRU S129 IRU LWV SURGXFWLRQ LQ WKH HYHQW 0,5 FRUQ  ” CP4 EPSPS protein (5-enolpyruvylshikimate- 3-phosphate synthase) and the genetic material (vector PV-ZMIR10871) necess ary for its production in corn event 021 «”  *Percentage (wt/wt) on a dry weight basis for whole pl ant (forage) of MON 89034 × MIR162 × MON 87411 plants. 08/17/2026 524-635

KEEP OUT OF REACH OF CHILDREN Caution EPA Registration No. 524-635 EPA Establishment No. 524-MO-002 Bayer CropScience LLC 800 North Lindbergh Blvd. St Louis, MO 63167 NET CONTENTS__________ DIRECTIONS FOR USE It is a violation of Federal law to use this product in any manner inconsistent with its labeling. Information regarding commercial pr oduction reflected here and in the terms and conditions ofthis registration must be included in the Technology Use Guide. MON 89034 × MIR162 × MON 87411 protects corn plants from leaf, stalk, and ear damage caused by corn borers and corn e arworm, and root damage caused by corn rootworm. In order to minimize the risk of these pests devel oping resistance to MON 89034 × MIR162 × MON 87411 corn, an in sect resistance management (IRM) plan must be implemented which includes planting of a structured refuge. This plant-incorporated protectant (PIP) may be combined through conventional breeding with other registered PIPs that are simila rly approved for use in combination, through conventional breeding, with other registered PIPs. 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. These refuge requirements do not apply to planting of inbred/hybrid corn seed productions, breeding, and small scale 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. Several options for deployment of th e refuge for MON 89034 × MIR162 × MON 87411 are available to growers. These options are based on the planting of MON 89034 × MIR162 × MON 87411 in cotton or non-cotton grow ing regions and the insect pressure present in those locations. The refuge sizes for these regions are either 5% (i.e. 5 acres of non-PIP corn for every 95 acres MON 89034 × MIR162 × MON 87411 corn planted) or

20% (20 acres of non-PIP corn for every 80 acres of MON 89034 × MIR162 × MON 87411 corn planted), and are presented in the table below: Region Refuge size In-field or adjacent refuge Refuge separated by up to ½ mile Cotton growing states where CEW is a significant pest and WCRW, NCRW and MCRW are not significant: AR, NC, SC, GA, FL, TN (only the counties of Carroll, Chester, Crockett, Dyer, Fayette, Franklin, Gibson, Hardeman, Hardin, Haywood, Lake, Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby, and Tipton), AL, MS, LA, and VA (only the counties of Dinwiddie, Franklin City, Greensville, Isle of Wight, Northampton, Southampton, Suffolk City, Surrey, and Sussex) 20% non-PIP corn Yes Yes Cotton growing states where CEW is a significant pest and WCRW, NCRW and/or MCRW are significant: TX (except the counties of Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, Moore, Ochiltree Roberts, and Sherman), OK (only the counties of Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, and Washita), and MO (only the counties of Dunklin, New Madrid, Pemiscot, Scott, and Stoddard) 20% non-PIP corn Yes No Cotton growing states where CEW is not a significant pest and WCRW, NCRW and MCRW are not significant: NM, AZ, CA, NV 5% non-PIP corn Yes Yes Non-cotton growing states where WCRW, NCRW and MCRW are not significant: OR, WA, ID, MT, WY, UT, VA (except the counties of Dinwiddie, Franklin City, Greensville, Isle of Wight, Northampton, Southampton, Suffolk City, Surrey, and Sussex) , WV, PA, MD, DE, CT, RI, NJ, NY, ME, MA, NH, VT, HI, AK and TN (except the counties of Carroll, Chester, Crockett, Dyer, Fayette, Franklin, Gibson, Hardeman, Hardin, Haywood, Lake, Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby, and Tipton) 5% non-PIP corn Yes Yes Non-cotton growing states where WCRW, NCRW and/or MCRW are significant: KS, NE, SD, ND, MN, IA, MO (except the counties of Dunklin, New Madrid, Pemiscot, Scott, and Stoddard), IL, WI, MI, IN, OH, KY, CO, OK (except the counties of Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, and Washita), and TX (only the counties of Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, Moore, Ochiltree, Roberts, and Sherman) 5% non-PIP corn Yes No If corn rootworms (CRW) are si gnificant within a region, the structured refuge must be planted as an in-field or adjacent refuge using corn hybrids that do not contain PIP

technologies for the control of corn borers or CRW. The structured refuge can be planted as a block within or adjacent (e.g., acro ss the road) to the MON 89034 × MIR162 × MON 87411 field, perimeter strips (i.e., strips around the field), or in-field strips. If perimeter or in-field strips are implemented, the strips must be at least 4 consecutive rows wide. The refuge can be protected fr om lepidopteran dama ge by use of non-Bt insecticides if the population of one or mo re target lepidopteran pests of MON 89034 × MIR162 × MON 87411 in the refuge exceeds economic threshold. In addition, the refuge can be protected from CRW dama ge by an appropriate seed trea tment or soil insecticide; however, insecticides labeled for adult CRW control should be avoided in the refuge during the period of CRW adult emergence . Economic thresholds will be determined using methods recommended by local or regi onal professionals (e.g., Extension Service agents, crop consultants). A schematic of one common ref uge deployment option is shown below: Structured Refuge If CRW are not significant within a region, the structured refuge may be planted as an in- field or adjacent refuge, or as a separate block that is within ½ mile of the MON 89034 × MIR162 × MON 87411 field. The structured ref uge must be planted with corn hybrids that do not contain PIP technologies for the control of corn borers or CRW. Economic thresholds will be determined using methods recommended by local or regional professionals (e.g., Extension Service agents , crop consultants). A schematic of one refuge option with the refuge planted within a ½ mile of the MON 89034 × MIR162 × MON 87411 field is shown below: Separated Structured Refuge MON 89034 × MIR162 × MON 87411 Refuge Non-PIP corn MON 89034 × MIR162 × MON 87411 ч ½ mile Refuge Non-PIP corn

Corn Insects Controlled or Suppressed European corn borer (ECB) Ostrinia nubilalis Southwestern corn borer (SWCB) Diatraea grandiosella Southern cornstalk borer (SCSB) Diatraea crambidoides Corn earworm (CEW) Helicoverpa zea Fall armyworm (FAW) Spodoptera frugiperda Stalk borer Papaipema nebris Sugarcane borer (SCB) Diatraea saccharalis Beet armyworm Spodoptera exigua True armyworm Pseudelatia unipuncta Black cutworm Agrotis ipsilon Western bean cutworm (WBC) Striacosta albicosta Lesser cornstalk borer Elasmopalpus lignosellus Dingy Cutworm Feltia jaculifera Western corn rootworm (WCRW) Diabrotica virgifera virgifera Mexican corn rootworm (MCRW) Diabrotica virgifera zeae Northern corn rootworm (NCRW) Diabrotica barberi Sales of corn hybrids that c ontain Bayer’s PIPs must be accompanied by either a grower guide or bag tag which includes informat ion on planting, production, and IRM and notes that routine applications of insecticides to control these insects are usually unnecessary when corn containing the PIPs are planted.

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MON 89034 × MIR162 × MON 87411 is a product of Bayer’s research program offering unique genetic characteristics for specific grower needs and may be protected by one or more of the following U.S. patents that can be found at http://cs.bayerpatents.bayer.com