crop-chem-docs/corpus/epa_ppls/524-489.md

MON 810

• EPA Reg No: 524-489
• Registrant: BAYER CROPSCIENCE, LLC
• Signal word: Caution
• Active ingredients: Bacillus thuringiensis Cry1Ab protein and the genetic material (PV-ZMBK07) necessary for its production in corn event MON-00810-6; % dry weight (0.0014%)
• Label accepted: 2019-02-26
• Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00489-20190226.pdf

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

February 26, 2019

David J. Chi Regulatory Affairs Manager Monsanto company 800 North Lindbergh Blvd. St. Louis, MO 63167

Subject: Labeling Notification pe r Pesticide Registration Notice (PRN) 98-10– Alternative brand names and/or primary brand names revisions and other minor ch anges Product Name: MON 810 EPA Registration Number: 524-489 Application Date: October 17, 2018 OPP Decision Number: 547095

Dear Mr. Chi:

The U.S. Environmental Protection Agency (EPA) is in receipt of your application for notification under Pesticide Registration Notice (PRN) 98-10 for the above referenced product. The Biopesticides and Pollution Prevention Division (BPPD) has conducted a review of this request for its applicability under PRN 98-10 and finds that the action requested falls within the scope of PRN 98-10.

The labeling submitted with this application has been stamped “Notification” and will be placed in our records. You must submit one (1) copy of the final printed labeling with the modifications.

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 the Federal Insecticide, Fungicide, and Rodenticide Act (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 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.

Page 2 of 2 EPA Reg. No. 524-489 OPP Decision No. 547095

If you have any questions, please contact Michael Glikes of my team by phone at (703) 231-6499 or via email at glikes.michael@epa.gov.

S i n c e r e l y ,

A l a n R e ynolds, Team Leader E m e r g i n g T e c hnologies Branch Biopesticides and Pollution Prevention Division (7511P) Office of Pesticide Programs

Enclosure

Monsanto Company CR267-18E1 Page 1 of 2 Plant-Incorporated Protectant Label MON 810 Corn Borer-Protected Corn Seed (Alternate brand name: YieldGard ® Corn Borer) (OECD Unique Identifier: MON-ØØ81Ø-6) Active Ingredient: Bacillus thuringiensis Cry1Ab delta-endotoxin and the genetic material necessary for its production (Vector PV-ZMCT01) in event MON 810 corn (OECD Unique Identifi er: 021‘‘‘  ”* *Percentage (wt/wt) on a dry weight basis for whole plant (forage). KEEP OUT OF REACH OF CHILDREN CAUTION EPA Registration No. 524-489 EPA Establishment No. 524-MO-002 Monsanto Company 800 North Lindbergh Blvd. St. Louis, MO 63198 NET CONTENTS__________ ®YieldGard is a registered trademark of Monsanto Technology, LLC. 524-489 02/26/2019

Monsanto Company CR267-18E1 Page 2 of 2 DIRECTIONS FOR USE It is a violation of federal law to use t his product in a manner inconsistent with its labeling. Seed containing MON 810 may only be planted for the purposes of agronomic ev aluation, seed increase and production in breeding nurseries as specified in the ter ms and conditions of this registration and on the labeling. Commercial plantings of this produ ct for the purposes of grain production and controlling insect pests are prohibited. This plant-incorporated protectant (PIP) may be combined through conven tional breeding with other registered plant-incorporated protectants that are similarl y approved for use in combination, through conventional breeding, with other plant-incorpor ated protectants to produce inbred corn lines and hybrid corn varieties with combined pestici dal traits. Plants that contain the pesticide product may be grown on 20,000 acres per c ounty and a total of 250,000 acres or less in total per year in the U.S. Harvested seed should not be allowed for sale as commercial seed in the U.S. under the current conditions of this registration but any grain containing MON 810 m ay be handled in accordance with legal and regulatory requirements (non-treated seed can be sold as grain). There are no refuge requirements for planting of MON 810 Corn. CORN INSECTS CONTROLLED OR SUPPRESSED Field corn has been genetically transformed to produce the B.t. Cry1Ab protein for the control or suppression of the following lepidopteran insects: 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)

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MON 810 is a product of Monsanto’s research program offering unique geneti c characteristics for specific grower needs and may be protected by one or mo re U.S. Patents found at the following web page: www.monsantotechnology.com.