crop-chem-docs/corpus/epa_ppls/524-619.md

MON 87751

• EPA Reg No: 524-619
• Registrant: BAYER CROPSCIENCE, LLC
• Signal word: Caution
• Active ingredients: Bacillus thuringiensis Cry1A.105 protein and the genetic material (Vector PV-GMIR1316) necessary for production in Mon 87751 soybean (0.00032%); Bacillus thuringiensis Cry2Ab2 protein and the genetic material (Vector PV-GMIR1316) necessary for production in Mon 87751 soybean (0.00051%)
• Label accepted: 2015-05-13
• Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00619-20150513.pdf

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION May 13, 2015 Debbie Mahadeo Regulatory Affairs Manager Monsanto Company 800 N. Lindbergh Blvd. St. Louis, MO 63167 Subject: Non-PRIA (Pesticide Registration Improvement Act) Labeling Amendment – Add a statement to allow non-treated seed containing MON 87751 to be sold as grain and edit page numbers and edit 524-XXX to 524-619 Product Name: MON 87751 EPA Registration Number: 524-619 Application Date: May 12, 2015 OPP Decision Number: 504928 Dear Ms. Mahadeo: The amended labeling referred to above, submitted in connection with registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, is acceptable. This approval does not affect any terms or conditions that were previously imposed on this registration. You continue to be subject to existing terms or conditions on your registration and any deadlines connected with them. A stamped copy of your labeling is enclosed for your records. This labeling supersedes all previously accepted labeling. You must submit one (1) copy of the final printed labeling before you release this product for shipment with the new 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. 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 U.S. Environmental Protection Agency (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

Page 2 of 2 EPA Reg. No. 524-619 OPP Decision No. 504928 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 false or misleading statements or claims substantially differing from the EPA-approved 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. If you have any questions, please contact Kenneth Haymes, Ph.D. of my team by phone at (703) 347- 0398 or via email at haymes.kenneth@epa.gov. Sincerely, Alan Reynolds, Team Leader Microbial Pesticides Branch Biopesticides and Pollution Prevention Division (7511P) Office of Pesticide Programs Enclosure: stamped label

Monsanto Company SY258-14E1 524-619 Page 1 of 2

Plant-Incorporated Protectant Label

MON 87751 Lepidopteran-Protected Soybean (OECD Unique Identifier MON-87751-7)

Active Ingredients: Bacillus thuringiensis Cry1A.105 protein and the genetic material necessary for its production (vector PV-GMIR13196) in MON 87751 soybean (OECD Unique Identifier MON-87751-7) ........................................................................................................................... ≤0.00032%*

Bacillus thuringiensis Cry2Ab2 protein and the genetic mate rial necessary for its production (vector PV-GMIR13196) in MON 87751 soybean (OECD Unique Identifier MON-87751-7) ........................................................................................................................... ≤0.00051%*

• Maximum percent (wt/wt) of dry grain.

KEEP OUT OF REACH OF CHILDREN

CAUTION

Net Contents __________

EPA Registration Number 524-619 EPA Establishment Number 524-MO-002

Monsanto Company 800 North Lindbergh Blvd. St. Louis, Missouri 63167

05/13/2015 524-619

Monsanto Company SY258-14E1 524-619 Page 2 of 2

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 onl y 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 labelin g. Commercial plantings of this product for the purposes of grain production and controlling insect pests are prohibited. MON 87751 soybean may be combined through conve ntional breeding with other registered plant incorporated protectants that are similarly approved for use in combination, through conventional breeding, with other registered pl ant-incorporated protectants to produce soybean varieties with combined pesticidal traits.

Soybean has been transformed to express Bacillus thuringiensis Cry1A.105 and Cry2Ab2 proteins for the control of the following lepidopteran soybean pests: Soybean velvetbean caterpillar Anticarsia gemmatalis Soybean looper Chrysodeixis includens Soybean axil borer Crocidosema aporema Sunflower looper Rachiplusia nu Corn earworm Helicoverpa zea Fall armyworm Spodoptera frugiperda

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-tre ated seed containing MON 87751 may be sold as grain. There are no refuge requirements for planting MON 87751 Soybean.