crop-chem-docs/corpus/epa_ppls/524-625.md

MON 89034 X MIR162

• EPA Reg No: 524-625
• 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 (0.0059%); Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary (vector PV-ZMIR245) for its production in corn (0.0043%); Bacillus thuringiensis Vip3Aa20 protein encoded by vector pNOV1300 in event MIR162 corn (SYN-IR162-4), % dw (0.015%)
• Label accepted: 2018-07-05
• Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00625-20180705.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 to:  Correct the common name of P. nebris as a target pest;  Remove “TreceptaTM corn” as an alternate brand name;  Modify the designations for the active and inactive ingredients;  Replace the registration number “524-AEL” with “524-625;”  Make minor changes to the Directions for Use. Product Name: MON 89034 x MIR162 EPA Registration Number: 524-625 Application Dates: March 29, 2018 OPP Decision Numbers: 542188 Dear Mr. Chi: In an application dated March 29, 2018, you notified the U.S. Environmental Protection Agency (EPA) that you requested to modify the designations for the active and inactive ingredients, correct the common name of P. nebris as a target pest, remove “TreceptaTM corn” as an alternate brand name, replace the registration number “524-AEL” with “524-625,” and make minor changes to the Directions for Use section. 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 Number 542188). The amended labeling referred to above, submitted in connection with registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, is acceptable. The alternate brand name “TriceptaTM Corn” has 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. 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

Page 2 of 2 EPA Reg. No. 524-625 OPP Decision Nos. 542188 product for shipm ent 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 × MIR162 Lepidopteran-Protected Corn (OECD Unique Identifier: MON-89Ø34-3 × SYN-IR162-4) This product is effective in controlling leaf, stalk, and ear damage cause d by corn borers a n dc o r ne a r w o r m . Active Ingredients: Bacillus thuringiensis Cry1A.105 and the genetic material (vector PV-ZMIR245) necessary for its production in MON 89034 × MIR162 corn (OECD Unique Identi fier: 021‘î6<1,5 ” Bacillus thuringiensis Cry2Ab2 and the genetic material (vector PV-ZMIR245) necessary for its production in MON 89034 × MIR162 corn (OECD Unique Identifier: 021‘î6<1,5 ” Bacillus thuringiensis Vip3Aa20 and the genetic material (vector pNOV1300) necessary for its production in MON 89034 × MIR162 corn (OECD Unique Identifier: 021‘î6<1,5 ” Other Ingredients: Phosphomannose isomerase (PMI) marke r protein and the genetic material ( vector pNOV1300) necessary for its production in MON 89034 × MIR162 corn (OECD Uni que ,GHQWLILHU021‘î6<1,5 ” *Percentage (wt/wt) on a dry weight basis for whole plant (forage) of MON 89 034 × MIR162 plants. KEEP OUT OF REACH OF CHILDREN CAUTION NET CONTENTS__________ EPA Registration No. 524-625 EPA Establishment No. 524-MO-002 07/05/2018 524-625

Monsanto Company 800 North Lindbergh Blvd. St. Louis, MO 63167 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 × MIR162 can be used to protect corn plants from leaf, stalk, and ea r damage caused by corn borers and corn earworm. 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. Refuge Requirements for MON 89034 × MIR162 Field Corn In order to minimize the risk of corn borers and corn earworm developing res istance to MON 89034 × MIR162 field corn, an insect resistance management plan must be implemented which includes planting of a structured refuge. For the sole purpose of manufacturing and small scale research trials for o bservation, these refuge requirements do not apply to seed increase/propagation of in bred and hybrid seed corn up to a total of 20,000 acres per county and up to a combined United S tates (U.S.) total of 250,000 acres per plant -incorporated protectant (PIP) ac tive ingredient per registrant per year. a) Corn-Belt/Non-Cotton-Growing Area Refuge Requirements For MON 89034 × MIR162 field corn grown outside cotton-growing areas (e.g. ,t h eC o r n Belt), grower guides must specify that growers must adhere to the followin gr e f u g e requirements. Growers must plant a structured refuge of at least 5% corn, which is not a Lep idopteran- protected B.t. corn hybrid. The refuge may be treated with insecticides, as detailed below, to control Lepidopteran s talk-boring and other pests.

Insecticide treatments for pests listed on this label may be applied only i f economic thresholds are reached for one or more of these target pests. Economic thre sholds will be determined using methods recommende d by local or regional professionals (e.g., Extension Service agents or crop cons ultants). Instructions to growers w ill specify that microbial B.t. insecticides must not be applied to non- B.t. corn refuges. Refuge planting options include: separate fields, blocks within fields ( e.g., along the edges or headlands), perimeter str ips, and strips across the field. External refuges must be planted within ½ mile. When planting the refuge in strips across the field, refuges must be at leas t four (4) consecutive rows wide. b) Cotton-Growing Area Refuge Requirements 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, Sussex), and Missouri ( only the counties of Dunklin, New Madrid , Pemiscot, Scott, Stoddard). MON 89034 × MIR162 (95 acres) ”½ mile Refuge Non-B.t. lepidopteran- protected corn (5 acres) MON 89034 × MIR162 (95 acres) Refuge Non-B.t. lepidopteran- protected corn (5 acres)

For MON 89034 × MIR162 field corn grown in cotton-growing areas, grower gui des must specify that growers must adhere to the following refuge requirement s. Growers must plant a structured refuge of at least 20% corn, which is not a le pidopteran- protected B.t. corn hybrid. The refuge may be treated with insecticides, as detailed below, to control lepidopteran stalk-boring and other pests. Insecticide treatments for pests listed on this label may be applied only i f economic thresholds are reached for one or more of these target pests. Economic thre sholds will be determined using methods recommende d by local or regional professionals (e.g., Extension Service agents, crop consul tants). Instructions to growers wi ll specify that microbial B.t. insecticides must not be applied to non- B.t. corn refuges. Refuge planting options include: separate fields, blocks within fields ( e.g., along the edges or headlands), perimeter str ips, and strips across the field. External refuges must be planted within ½ mile. When planting the refuge in strips across the field, refuges must be at leas t four (4) consecutive rows wide. MON 89034 × MIR162 (80 acres) ”½ mile Refuge Non-B.t. lepidopteran- protected corn (20 acres) MON 89034 × MIR162 (80 acres) Refuge Non- B.t. lepidopteran - protected corn (20 acres)

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 Sugarcane borer Diatraea saccharalis Beet armyworm Spodoptera exigua True armyworm Pseudelatia unipuncta Black cutworm Agrotis ipsilon Western bean cutworm Striacosta albicosta Lesser cornstalk borer Elasmopalpus lignosellus Dingy Cutworm Feltia jaculifera 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 appl ications of insecticides to control these insects are usually unnecessary when corn c ontaining the B.t. proteins is planted.

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MON 89034 × MIR162 is a product of Monsanto’s research program offering uni que genetic characteristics for specific grower needs and may be protected by one or mo re of the following U.S. patents that can be found at http://www.monsantotechnology.com