crop-chem-docs/corpus/epa_ppls/524-597.md

MON 89034 SEED BLEND

• EPA Reg No: 524-597
• 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 (0.0056%); Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary (vector PV-ZMIR245) for its production in corn (0.0055%)
• Label accepted: 2018-07-05
• Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00597-20180705.pdf

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION July 5, 2018 David Chi Regulatory Affairs Manager Monsanto Company 800 North Lindbergh Blvd. St. Louis, Missouri 63167 Subject: Non-PRIA (Pesticide Registration Improvement Act) Labeling Amendment – • Make minor changes to designations for the active and inactive ingredients; • Add fall armyworm (S. frugiperda) as a target pest; • Make minor changes to the Directions for Use; • Remove Genuity® VT Double PRO® RIB Complete® as an Alternate Brand Name; • Remove VT Double PRO® RIB Complete® Corn Blend as an Alternate Brand Name; • Correct the name of Crockett County in the list of cotton-growing areas. Product Name: MON 89034 Seed Blend EPA Registration Number: 524-597 Application Date: 3/29/2018 OPP Decision Number: 542194 Dear Mr. Chi: In an application dated March 29, 2018, you notified the U.S. Environmental Protection Agency (EPA) that you requested to make minor changes to designations for the active and inactive ingredients, add fall armyworm (S. frugiperda) as a target pest, make minor changes to the Directions for Use, and correct the name of Crockett County in the list of cotton-growing areas. Subsequently, the EPA determined that the actions requested do not fall under the scope of Pesticide Registration Notice 98-10 and therefore converted the notification to a non-PRIA amendment (OPP Decision No. 542194). The amended labeling referred to above, submitted in connection with registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, is acceptable. Additionally, the alternate brand names Genuity® VT Double PRO® RIB Complete® and VT Double PRO® RIB Complete® Corn Blend have been removed from the registration, and our records have been updated accordingly. 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.

Page 2 of 2 EPA Reg. No. 524-597 OPP Decision Nos. 542194 A stam ped 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 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. 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 Matt Weiner by phone at 703-347-0333 or via email at weiner.matthew@epa.gov. Sincerely, A l a n R eynolds, Team Leader E m e r g i n g T e chnologies Branch Biopesticides and Pollution Prevention Division (7511P) Office of Pesticide Programs Enclosure

Plant-Incorporated Protectant Label MON 89034 Seed Blend Lepidopteran-Protected Corn (OECD Unique Identifier MON-89Ø34-3) Active Ingredients: Bacillus thuringiensis Cry1A.105 protein and the genetic material (vector PV-ZMIR245) necessary for its production in MON 89034 (OECD Unique Identifier: MON-89 Ø34-3)  ” Bacillus thuringiensis Cry2Ab2 protein and the genetic material (vector PV-ZMIR245) necessary for its production in MON 89034 (OECD Unique Identifier: MON-89 Ø34-3)  ”

• Percentage (wt/wt) on a dry weight basis whole plant (forage) The MON 89034 seed with this refuge configuration contains 95% MON 89034 mi xed with 5% non-B.t. corn within a single lot of seed. KEEP OUT OF REACH OF CHILDREN CAUTION NET CONTENTS__________ EPA Registration No. 524-597 EPA Establishment No. 524-MO-002 Monsanto Company 800 North Lindbergh Blvd. St. Louis, Missouri 63167 07/05/2018 524-597

DIRECTIONS FOR USE It is a violation of Federal law to use this product in any manner inconsiste nt with its labeling. Information regarding co mmercial production as specified in t he terms and conditions of this registration must b e included in the Technology Use Gui de and/or Insect Resistance Management (IRM) Grower Guide. MON 89034 can be used to protect corn plants from leaf, stalk, and ear damage caused by corn borers. Refuge Requirements A refuge must consist of corn hybrids that do not contain B.t. technologies for the control of corn borers. This product achieves the required refuge as the refuge is i nterspersed within the field and occurs only by planting a licensed seed-mixture conta ining MON 89034 or MON 89034 stacked with other non-PIP technologies, with a mini mum of 5% non-PIP seed. This refuge configuration complies with refuge requir ements only in the U.S. Corn Belt. The sufficiency of this refuge configuration is defined by geography, and ultimately is based on insect presence and species. The seed mix refuge option for MON 89034 complies with refuge requirements only in the U.S. Corn Belt. The 95/5% MON 89034 seed mix product may be planted in cotton growing areas: however, planting the 95/5% MON 89034 seed mix in cotton growing areas stil l requires planting an additional 20% structured refuge (block, strips, or border) a sd e f i n e df o r MON 89034 EPA registration 524-575. The interspersed refuge option for MON 89034 does not alone comply with refuge requirements in cotton growing areas. Cotton-growing areas include the following states: Alabama, Arkansas, G eorgia, Florida, Louisiana, North Carolina, Missis sippi, South Carolina, Oklahoma (only the counties of Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Ti llman, and Washita), Tennessee (only the coun ties of Carroll, Chester, Crockett, Dy er, Fayette, Franklin, Gibson, Hardeman, Hardin, Haywood, Lake, Lauderdale, Lincoln , Madison, Obion, Rutherford, Shelby, and Tipton), Texas (except the counties of Car son, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, Moore, Ochiltree, Roberts, an d Sherman), Virginia (only the counties of Dinwiddie, Franklin City, Greensville, Is le of Wight, Northampton, Southampton, Suffolk City, Surrey, and Sussex), and Missou ri (only the counties of Dunklin, New Madrid, P emiscot, Scott, and Stoddard).

The seed mix (interspersed) refuge option under this registration is limi ted to planting specifically licensed seed corn of MON 89034 and MON 89034 stacks with non- PIP corn. With this option, the field containing an interspersed refuge may be treat ed with labeled insecticides to control additional cor n pests, including larval or adult lepidopteran pests, because both the MON 89034 and refuge are treated in the same manner. Insect icide treatments for control of European co rn borer, corn earworm, southwester n corn borer, southern cornstalk borer, sugarcane borer, fall armyworm, lesser cornst alk borer, and stalk borer may be applied only if economic thresholds are reached for one o r more of these target pests. Economic thresholds will be determined using methods recommended by local or regional professionals (e.g., Extension Service agents, crop consultants). Microbial B.t. insecticides must not be applied to the field containing a seed mix interspersed refuge. 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 Lesser cornstalk borer Elasmopalpus lignosellus Sugarcane borer Diatraea saccharalis Sales of corn hybrids that contain Monsanto’s B.t. corn plant-incorporated protectant must be accompanied by a grower guide which includes information on planti ng, production and insect resistance management and notes that routine appli cations of insecticides to control these insects are usually unnecessary when corn c ontaining the B.t. proteins is planted. 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 br eeding, with other registered plan t-incorporated protectants to produce inbred corn lines and hybrid corn varieties with co mbined pesticidal traits. MON 89034 Seed Blend is a product of Monsanto’s research program offering u nique 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://www.monsantotechn ology.com