(84 of 886) Case: 17-70196, 02/09/2018, ID: 10759012, DktEntry: 71-1, Page 84 of 133 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASH INGTON, DC 20460 OFFICE OF CHEMICAL SAFETY A ND POLLU110N PREVENTION October I 2. 20 17 Thomas Marvin Director. Federal Regulatory Affairs Monsanto Company 1300 I (Eye) Street. NW - Suite -lSO East Washington. DC 20005 S u~j cct: Registration Amendment - Labc:l Amendment to Change Directions for llsl! and additional Tenns and Conditions to the Registration as Registered on November 9. 2016 lor Usc on Dicamba-tolerant Colton and Dicamba-tolcrant Soybeans Product Name: M 1768 I IERBICIDE (Xtcndimax with Vaporgrip Technology) EPA Registration Number: 524-617 Application Date: Octobc:r 41h. 2017 Decision Number: 534662 Dear Mr. Man·in. In response to the high number of crop damage incidents reported to EPA since June: 2017. Monsanto submitted a labc:l amendment to change the directions for usc on its product as well as a request to amend its registration to include additional terms and conditions. EPA approves the labeling proposed by Monsanto as well as the additional terms and conditions of registration. EPA has determined that theM 1768 llerbicidc: (EPA reg. no. 524-617. Xtc:ndimax \\'ith Vaporgrip Technology) labeling and registration continue to meet the standard of registration with the requested amendment as it did on November 9. 2016 ,,·hen EPA registered these new uses. ll1c: amendment approved through this letter includes additional rc:strictions further minimizing off-lield movement of the: active ingredient dicamba and do not all'ect the conclusions in the supporting assessment of risk. EPA accordingly continues to rely on all the assessments that supported the new uses. and therdore does not require a revised endangered species e llccts detl!rmination , nor any other new risk assessment. This approval contains registration terms and conditions that arc in addition to the conditions set fo1th in the new usc approval granted on November 9. 2016. These terms and conditions do not supersede any conditions that were pre,·iously imposed on this registration and supported by risk assessments found in the: following docket .EPA-IIQ-OPP-20 16-0187. Therelore. Monsanto cont inues to be subject to existing conditions on its registration and any deadlines connected with them. including but not limited to the automatic expiration date of November 9. 2018. The amended label referred to above. submilted in connection with registration under the federal lnscctic ide. Fungicide and Rodenticide Act. as amended. is acceptable under FIFRA Section 3(c)(7)(8) subject to the follo,,·ing additional terms and conditions to ensure that the new labc:ling is provided at the: point of sale for the 2018 usc season: A stamped copy o f your labc:ling is enclosed for your records. ll1is labeling supersedes all previously accepted labeling including all supplemental labels. ER 072 (85 of 886) Case: 17-70196, 02/09/2018, ID: 10759012, DktEntry: 71-1, Page 85 of 133 Page 2 of3 EPA Reg. No. 524-61 7 Decision No. 534662 I. Immediately. for product currently in retail inventories. in the distribution cha in (packaged and released for sh ipment). and product that wi II be manufactured before new glossy label booklets are available will be relabe led \·Vith a Sticker and a New Label. • • Sticker will contain the fo llo.,ving information: o .. Restricted Use Pesticide'·: o .. Product cannot be used if user does not possess new labe l(ing) that can be round at www.xtcndimaxapplicationrequirements.com: and o ·'User must comply in all respects with new label( ing). regardless of any contrary language on existing label.'' New label will be provided to accompany each stickcred product as well as pub Iication to Monsanto· s website 'vV\vw.:-:tendimaxapplicationrequirements.com. 2. The nex t label printing of this product, which shou ld occur as soon as practicable. must use this approved labeling unless subsequent changes have been approved. You must submit one copy of the final printed labeling before you release the product for shipment with lhe new labeling. After the next printing, you may only distribute or sell this product if it bears thi s nev.' revised labe ling or subsequently approved labeling ...To distribute or sell" is defined under FIFRA section 2(gg) and its implementing regulation at 40 CfR 152.3. In order to assure the new labeling is implemented for usc in the 2018 application season, the appended terms and conditions (listed here) have been added to the existing terms and conditions of this registration. Monsanto, the registrant. wil l: • • • • • As soon as new labeling (glossy booklets) become available. affix the new label to XtendiMax products at the time of manufacture in registered facilit ies. Notify EPA, \·Vi thin one \-veek of the booklet becoming available. of the date the booklet became available. All product manufactured after the booklet is available must contain the new glossy labe l. For other XtendiMax products- whether in retail inventories, in the distribution chain, or for which manufacturing will occur before new glossy label booklets become available- produce and distribute sufficient quantities of stickers and new paper labels to update product (recogniz ing that stickering must occur in a registered establishment). Inform retai lers of the need to sticker and supply new labels tor products currently in inventory and products received with the former label as well as provide specific instructions to the retailers that arc registered establishments on how to affix the sticker on the label and provide the new paper label at time of purchase. Inform reta ilers that are not yet EPA registered establ ishments about the importance of stickering the products currently in their inventory and products received with the former label and that stickering and providing the nev,: labels can only occur in an EPA registered establishment; inform retailers of the process for establishment registration and reporting; and communicate that retailers should not se ll product until stickering is appropriately conducted. ER 073 (86 of 886) Case: 17-70196, 02/09/2018, ID: 10759012, DktEntry: 71-1, Page 86 of 133 Page 3 of 3 EP/\ Reg. 1 o. 524-617 Decision No. 53-1-662 • • • In form retailers who do not intend to become registered establishments the importance of the nev.: labeling and to contact Monsanto immediate ly. so that Monsanto can reclaim the retailer inventory and provide replacement product with labeling updated in a registered establishment. Commun icate that reta ilers should not se ll product until stickering is appropriately conducted. Prov ide a copy to EPA ofthc communications used to inform retailers and others as described above. Provide access to new label through an internet webpagc located at wwv.:.xtendimaxapplicationrequirements.com. Please be aware that by adding/retaining a reference to the company· s website on your label. the w·ebsite becomes labeling under the Federal Insecticide Fungic ide and Rodenticide Act and is subject to review by the Agency. If the website is false or misleading. the prod uct vvould be misbranded and unlawful to sell or distribute under FlfR!\ section 12(a)( I)(E). 40 CFR 156.1 0(a)(5) li st examples of statements EPA may consider false or misleading. In addition. regard less of whether a website is referenced on your product's label. cla ims made on the webs ite may not substantially differ from those claims approved through the registration process. Therefore, shou ld the Agency find or if it is brought to our attention that a website contains false or misleading statements or claims substantially di ffe ring from the EPA approved registration. the website will be referred to the EPA's Office of Enforcement and Compliance. A stamped copy of your labeling is enclosed for your records. This labeling supersedes all previously accepted labeling including all supplemental labels. The new labeling and term s :md conditions of registration are hereby granted. /\s with the November 9, 20 16 new use approva ls for use of Xtendimax with VaporGripTM Technology on dicamba-tolerant cotton and dicamba-tolcrant soybeans, if these conditions are not complied with. the registration \:viii be subjec t to cance llation in accordance with FIFRA section 6. If you have any questions, please contact me by phone at 703-305- 1243. or via email at monlauuc .kathryn!cvcpa.!.!ov, Sincerely. ~v.~ Kathryn Montague. Product Manager 23 Herbicide Branch Registration Division (7505P) Office of Pesticide Programs Enc losure( s) ER 074 (87 of 886) Case: 17-70196, 02/09/2018, ID: 10759012, DktEntry: 71-1, Page 87 of 133 MASTER LABEL FOR EPA REG. NO. 524-617 RESTRICTED USE PESTICIDE For retail sale to and use only by Certified Applicators or persons under their direct supervision and only for those uses covered by the Certified Applicator's certification This labeling expires on 11 /09/2018, unless the U.S. EPA determines before that date that off-site incidents are not occurring at unacceptable frequencies or levels. Do not use or distribute this product after 11/09/2018, unless you visit www.xtendimaxapplicationrequirements.com and can verify that EPA has amended this expiration date. ACCEP TED Primary Brand Name: 10/ 12/2017 M1768 Herbicide Under the Fede,..llr tSCIChC;M1r: Fun!)l<:ldt- and Rodenlld