crop-chem-docs/corpus/epa_ppls/524-668.md

MON 94637

• EPA Reg No: 524-668
• Registrant: BAYER CROPSCIENCE, LLC
• Signal word: Caution
• Active ingredients: Bacillus thuringiensis Cry1A.2 Protein and the genetic material (Vector PV -GMIR527237) necessary for its production in MON 94637 soybean event (0.0043%); Bacillus thuringiensis Cry1B.2 Protein and the genetic material (Vector PV -GMIR527237) necessary for its production in MON 94637 soybean event (0.002%)
• Label accepted: 2025-09-16
• Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00668-20250916.pdf

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U.S. ENVIRONMENTAL PROTECTION AGENCY Office of Pesticide Programs Biopesticides and Pollution Prevention Division (7511M) 1200 Pennsylvania Ave., N.W. Washington, D.C. 20460 NOTICE OF PESTICIDE: ܈Registration ܆Reregistration (under FIFRA, as amended) EPA Reg. Number: 524-668 Date of Issuance: 9/16/2025 Term of Issuance: Unconditional Name of Pesticide Product: MON 94637 Lepidopteran- Protected Soybean Name and Address of Registrant (include ZIP Code): Bayer CropScience LP 800 North Lindbergh Boulevard St. Louis, MO 63167 Note: Changes in labeling differing in substance from that accepted in connection with this registration must be submitted to and accepted by the Biopesticides and Pollution Prevention Division prior to use of the label in commerce. In any correspondence on this product, always refer to the above EPA Registration Number. On the basis of information furnished by the registrant, the above named pesticide is hereby registered under the Federal Insecticide, Fungicide, and Rodenticide Act. Registration is in no way to be construed as an endorsement or recommendation of this product by the U.S. Environmental Protection Agency. In order to protect health and the environment, the Administrator, on his or her motion, may at any time suspend or cancel the registration of a pesticide in accordance with the Act. The acceptance of any name in connection with the registration of a product under the Act is not to be construed as giving the registrant a right to exclusive use of the name or to its use if it has been covered by others. This product is unconditionally registered in accordance with FIFRA section 3(c)(5) provided that you:

1. Submit and/or cite all data required for registration or registration review of your product when the EPA requires all registrants of similar products to submit such data.

Signature of Approving Official: Michael Mendelsohn, Chief Emerging Technologies Branch Biopesticides and Pollution Prevention Division (7511M) Office of Pesticide Programs Date: 9/16/2025 EPA Form 8570-6 MICHAEL MENDELSOHN Digitally signed by MICHAEL MENDELSOHN Date: 2025.09.16 09:52:51 -04'00'

Page 2 of 3 EPA Reg. No. 524-668 Action Case No. 00494632

2. The subject registration is limited to Bacillus thuringiensis Cry1A.2 and Bacillus thuringiensis Cry1B.2 proteins and the genetic material (vector PV-GMIR527237) necessary for their production in MON 94637 (OECD Unique Identifier: MON-94637-8) for use in soybean.

3. The subject registration may be combined through conventional breeding with other registered plant-incorporated protectants that are similarly approved for use in combination, through conventional breeding, with other registered plant-incorporated-protectants to produce soybean varieties with combined pesticidal traits.

4. Seed containing this plant-incorporated protectant product may only be planted for the purposes of agronomic evaluation, seed increase, and production in breeding nurseries as specified in the terms of this registration and on the labeling. Commercial plantings of this product for the purposes of grain production and controlling insect pests are prohibited.

5. The subject registration to a combined yearly total of 15,000 acres or less in the U.S. with no more than 1,000 acres per county (per municipio in Puerto Rico).

6. Harvested seed are not allowed for sale as commercial seed in the U.S. under the terms of this registration, but any non-treated seed containing event MON 94637 may be sold as grain.

7. Bayer CropScience LP must provide reference material, appropriate control substances and technical support if requested by the Food and Drug Administration to support the analytical method for the Cry1A.2 and Cry1B.2 proteins.

8. Upon request, Bayer CropScience LP must provide EPA by January 31st each year annual reports on the acreage where MON 94637 Lepidopteran-Protected Soybean has been grown by state and territory.

Should you wish to add/retain a reference to your company’s website on your label, then please be aware that the website becomes labeling under FIFRA and is subject to review by the EPA. If the website is false or misleading, the product 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 the 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 the 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 the EPA’s Office of Enforcement and Compliance Assurance.

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

A stamped copy of the labeling is enclosed for your records. Please also note that the record for this product currently contains the following acceptable Confidential Statement of Formula (CSF):

Page 3 of 3 EPA Reg. No. 524-668 Action Case No. 00494632 x Basic CSF dated November 6, 2023

If you have any questions, please contact Stephanie Kelly by phone at (202) 566-0890 or via email at kelly.stephanie@epa.gov.

Sincerely,

Michael Mendelsohn, Chief E m e r g i n g T e c h n o l o g i e s B r a n c h Biopesticides and Pollution Prevention Division (7511M) Office of Pesticide Programs

Enclosure: MON 94637 Stamped Label MICHAEL MENDELSOHN Digitally signed by MICHAEL MENDELSOHN Date: 2025.09.16 09:53:26 -04'00'

Plant-Incorporated Protectant Label MON 94637 Lepidopteran-Protected Soybean (OECD Unique Identifier MON-94637-8) Active Ingredients: Bacillus thuringiensis Cry1A.2 protein and the genetic material necessary for its production (vector PV-GMIR527237) in MON 94637 soybean (OECD Unique Identifier MON-94637-8) ................................................................................................... ”0.0043%* Bacillus thuringiensis Cry1B.2 protein and the genetic material necessary for its production (vector PV-GMIR527237) in MON 94637 soybean (OECD Unique Identifier MON- 94637-8) .............................................................................................................. ”0.0020%*

• Maximum percent (wt/wt) of dry grain. KEEP OUT OF REACH OF CHILDREN CAUTION Net Contents __________ EPA Registration Number 524-XXX EPA Establishment Number 524-MO-002 Bayer CropScience LP 800 North Lindbergh Blvd. St. Louis, Missouri 63167

M-844542-01-1

09/16/2025 524-668

DIRECTIONS FOR USE It is a violation of federal law to use this product in a manner inconsistent with its labeling. Seed containing this pesticide product may only be planted for the purposes of agronomic evaluation, seed increase and production in breeding nurseries as specified in the terms and conditions of this registration and on the labe ling. Commercial plantings of this product for the purposes of grain production and controlling insect pests are prohibited. MON 94637 soybean may be combined through conventi onal breeding with other registered plant incorporated protectants that are similarly approved for use in combination, through conventional breeding, with other regist ered plant-incorporated protectants to produce soybean varieties with combined pesticidal traits. Soybean has been transformed to express Bacillus thuringiensis Cry1A.2 and Cry1B.2 proteins for the control of the following lepidopteran soybean pests: Soybean looper Chrysodeixis includens Soybean velvetbean caterpillar Anticarsia gemmatalis Plants that contain the pesticide product may be grown on 15,000 acres or less in total per year in the U.S. with no more than 1,000 acres per county per year (per municipio in Puerto Rico). Harvested seed should not be allowed for sale as commercial seed in the U.S. under the current conditions of this registration, but any non-treated seed containing MON 94637 may be sold as grain. There are no refuge requirements for planting MON 94637 Soybean. 021/HSLGRSWHUDQ3URWHFWHG6R\EHDQ3HQGLQJ