crop-chem-docs/corpus/epa_ppls/524-584.md

MON 89034 X DAS-59122-7

• EPA Reg No: 524-584
• Registrant: BAYER CROPSCIENCE, LLC
• Signal word: Caution
• Active ingredients: Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for their production in corn (0.0236%); Bacillus thuringiensis Cry1A.105 protein and genetic material necessary (vector PV-ZMIR245) for its production in corn (0.0026%); Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary (vector PV-ZMIR245) for its production in corn (0.0053%)
• Label accepted: 2016-12-27
• Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00584-20161227.pdf

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David Chi UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D.C. 20460 December 27, 2016 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION Regulatory Affairs Manager Monsanto Company 800 North Lindbergh Blvd. St. Louis, MO 63 I 67 Subject: Dear Mr. Chi: Non-PRIA (Pesticide Registration Improvement Act) Labeling and Formulation Amendment - to update terms and conditions of registration , update CSF and labels with OECD unique identifiers and make other minor changes Product Name: MON 89034 x DAS-59122-7 EPA Registration Number: 524-584 Applica tion Date: November 23, 2015 and subsequent resubmissions OPP Decision Number: 513483 The amended labeling and Confidential Statement of Formula (CSF) referred to above, submitted in connection with registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, are 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 . Please note that the record for this product currently contains the following acceptable CSF : • Basic CSF dated 12/14/2016 Any CSFs other than those listed above are superseded/no longer valid. 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 subsequ ently approved labeling. "To distribute or sell" is defined under FIFRA section 2(gg) and its implementing regulation at 40 CFR § 152.3.

Page 2 of2 EPA Reg. No. 524-584 OPP Decision No. 513483 Should you wish to add 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 distributi on of the product is unlawful under FIFRA section 12(a)( l)(E) . 40 CFR § 156.1 O(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 constitute s 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 me by phone at (703) 605-0515 or via email at reynolds.alan@epa.gov . Enclosure Sincerely,

Microbial Pesticides Branch 
Biopesticide s and Pollution 
Prevention Division (751 lP) 
Office of Pesticide Programs

Plant-Incorporated Protectant Label 
 
MON 89034 × DAS-59122-7 
Insect-Protected, Herbicide-Tolerant Corn 
(OECD Unique Identifier: MON-89Ø34-3 × DAS-59122-7) 
 
 
Active Ingredients: 
Bacillus thuringiensis Cry1A.105 protein and the genetic material necessary (vector PV-
ZMIR245) for its production in MON 89034 × DAS-59122-7 Corn (OECD Unique 
Identifier MON-89Ø34-3 × DAS-59122-7)....................................................... ” 0.0026%* 
 
Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary (vector PV-
ZMIR245) for its production in MON 89034 × DAS-59122-7 Corn (OECD Unique 
Identifier MON-89Ø34-3 × DAS-59122-7) ..................................................... ” 0.0053%* 
 
Bacillus thuringiensis Cry34Ab1 protein and the genetic material necessary (vector 
PHP17662) for its production in MON 89034 × DAS-59122-7 Corn (OECD Unique 
Identifier MON-89Ø34-3 × DAS-59122-7)..................................................... . ” 0.0194%* 
 
Bacillus thuringiensis Cry35Ab1 protein and the genetic material necessary (vector 
PHP17662) for its production in MON 89034 × DAS-59122-7 Corn (OECD Unique 
Identifier MON-89Ø34-3 × DAS-59122-7)..................................................... . ” 0.0042%* 
 
Other Ingredients: 
PAT protein (phosphinothricin acetyl transferase) and the genetic material necessary 
(vector PHP17662) for its production in MON 89034 × DAS-59122-7 Corn (OECD 
Unique Identifier MON-89Ø34-3 × DAS-59122-7) ....................................... ” 0.00045%* 
 
*Maximum percent (wt/wt) of dry forage 
 
 
KEEP OUT OF REACH OF CHILDREN 
 
CAUTION 
 
NET CONTENTS_______ 
 
 
EPA Registration No. 524-584 
 
EPA Establishment No. 524-MO-002 
 
Monsanto Company 
800 North Lindbergh Blvd. 
St. Louis, MO 63167 
12/27/2016
524-584

DIRECTIONS FOR USE 
 
It is a violation of Federal law to use this product in any manner inconsistent with its 
labeling. 
 
This plant-incorporated protectant (PIP) may be combined through conventional breeding 
with other registered plant-incorporated protectants that are similarly approved for use in 
combination, through conventional breeding, with other registered plant-incorporated 
protectants to produce inbred corn lines and hybrid corn varieties with combined 
pesticidal traits. 
 
This product may be used for breeding purposes, agronomic testing, increasing inbred 
seed stocks, and producing hybrid seed on up to a total of 20,000 acres per county and up 
to a combined United States (US) total of 250,000 acres per plant incorporated protectant 
(PIP) active ingredient per registrant per year. Commercial plantings of this product, for 
the purposes of grain production and controlling corn insect pests, are prohibited. 
 
Harvested seed are not allowed for sale as commercial seed in the U.S. under the current 
conditions of this registration, but any non-treated seed containing MON 89034 × 
DAS-59122-7 may be sold as grain. 
 
There are no refuge requirements for planting MON 89034 × DAS-59122-7 Corn.