crop-chem-docs/corpus/epa_ppls/524-626.md

# MON 89034 X MIR162 SEED BLEND

- EPA Reg No: **524-626**
- 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/000524-00626-20180705.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 – 
 Modify the designations for the active and inactive ingredients;
 Removal of Trecepta™ RIB Complete® corn blend as an Alternate Brand Name;
 Make minor changes to the Directions for Use.
Product Name: MON 89034 x MIR162 Seed Blend 
EPA Registration Number: 524-626 
Application Dates: 3/29/2018 
OPP Decision Numbers: 542190 
Dear Mr. Chi: 
In an application dated March 29, 2018 (OPP Decision No. 542190), you notified the U.S. 
Environmental Protection Agency (EPA) that you requested to modify the designations for the active 
and inactive ingredients, to remove Trecepta™ RIB Complete® corn blend as an Alternate Brand 
Name, and to make minor changes to the Directions for Use. Subsequently, the EPA determined that the 
actions requested do not fall under the scope of Pesticide Registration Notice (PRN) 98-10 and therefore 
converted the notification to a non-PRIA amendment (OPP Decision No. 542190). 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, Trecepta™ RIB Complete® corn blend has been removed from the registration. 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 
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

Page 2 of 2 
EPA Reg. No. 524-626 
OPP Decision Nos. 542190 
or subsequently approved labeling. “To distribute or sell” is defined under FIFRA section 2(gg) and its 
im
plementing 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. 
S i n c e r e l y , 
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 Seed Blend
Lepidopteran-Protected Corn
(OECD Unique Identifier: MON-89Ø34-3 × SYN-IR162-4)
Active Ingredients:
Bacillus thuringiensis Cry1A.105 and the genetic material (vector PV-ZMIR245) necessary for
its production in MON 89034 × MIR162 corn (OECD Unique Identifier: MON-89Ø 34-3 ×
6<1,5 ”
Bacillus thuringiensis Cry2Ab2 and the genetic material (vector PV-ZMIR245) necessary for its
production in MON 89034 × MIR162 corn (OECD Unique Identifier: MON-89Ø34- 3×
6<1,5 ”
Bacillus thuringiensis Vip3Aa20 and the genetic material (vector pNOV1300) necessary for its
production in MON 89034 × MIR162 corn (OECD Unique Identifier: MON-89Ø34- 3×
6<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 Unique Identi fier:
021‘î6<1,5 ”
*Percentage (wt/wt) on a dry weight basis for whole plant (forage) of MON 89 034 ×
MIR162 plants.
The MON 89034 × MIR162 seed with this refuge configuration contains 95% MON 89034 ×
MIR162 mixed with 5% non- B.t. corn within a single lot of seed
KEEP OUT OF REACH OF CHILDREN
CAUTION
NET CONTENTS__________
EPA Registration No. 524-626
EPA Establishment No. 524-MO-002
07/05/2018
524-626

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 commercial p roduction as specified in the terms an d conditions of this
registration must be included in the Technology Use Guide and/or Insect Re sistance
Management (IRM) Grower Guide.
MON 89034 × MIR162 can be used to protect corn plants from leaf, stalk, and ea rd a m a g e
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 similarly app roved for use in
combination, through conventional b reeding, with other registered plan t-incorporated protectants
to produce inbred corn lines and hybrid corn varieties with combined pesti cidal traits.
Refuge Requirements
A refuge must consist of corn hybrids that do not contain B.t. technologies for the control of corn
borers and corn earworm. This product achieves the required refuge as the r efuge is interspersed
within the field and occurs only by planting a licensed seed-mixture conta ining MON 89034 ×
MIR162 or MON 89034 × MIR162 stacked with other non-PIP technologies, with a minimum of
5% non-PIP seed. This refuge configuration complies with refuge requirem ents only in the U.S.
Corn Belt.
The sufficiency of this refuge configuration is defined by geography and u ltimately is based on
insect presence and species. The seed mix refuge option for MON 89034 × MIR162 complies
with refuge requirements only in the U.S. Corn Belt .
The 95/5% MON 89034 × MIR162 seed mix product may be planted in cotton growin ga r e a s ;
however, planting the 95/5% MON 89034 × MIR162 seed mix in cotton growing ar eas still
requires planting an additional struc tured refuge of at least 20% corn, wh ich is not a
lepidopteran-protected B.t. corn hybrid. The refuge may be treated with insecticides, as detailed
below, to control lepidopteran stalk-boring and other pests. The interspersed refuge option for
MON 89034 × MIR162 does not alone comply with refuge requirements in cotton growing
areas.
Structured refuge planting options in clude: separate fields, blocks wit hin fields (e.g., along the
edges or headlands), per imeter strips, and strips across the field. Exter nal refuges must be
planted within ½ mile. When planting the refuge in strips across the field, refuges must be at
least four(4) consecutive rows wide.

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, La ke, Lauderdale, Lincoln, Madison, Obion, Rutherford,
Shelby, and Tipton), Texas (except the counties of Carson, Dallam, Hansfo rd, Hartley,
Hutchinson, Lipscomb, Moore, Ochiltree, Roberts, and Sherman), Virgini a (only the counties of
Dinwiddie, Franklin City, Greensvi lle, Isle of Wight, Northampton, Sout hampton, Suffolk City,
Surrey, and Sussex), and Missouri (only the counties of Dunklin, New Madri d, Pemiscot, Scott,
and Stoddard).
The seed mix (interspersed) refuge option under this registration is limi ted to planting
specifically licensed seed corn of MON 89034 × MIR162 and MON 89034 × MIR162 stacks
with non-PIP corn.
The field containing an interspersed refuge may be treated with labeled in secticides to control
additional corn pests, including larv al or adult lepidopteran pests, bec ause both the MON 89034
× MIR162 and refuge are treated in the same manner. Insecticide treatments for control of pests
listed on this label may be applied only if economic thresholds are reached for one or more of
these target pests. Economic thresholds will be determined using methods recommended by
local or regional professionals (e.g., Extension Service agents, crop co nsultants). Microbial B.t.
insecticides must not be applied to the field containing a seed mix intersp ersed 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 inbred a nd hybrid seed corn up
to a total of 20,000 acres per county and up to a combined United States (U.S. ) total of 250,000
acres per plant-incorporated protectant (PIP) active ingredient per reg istrant per year.
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 planting, pro duction, and insect
resistance management and notes that routine applications of insecticid es to control these insects
are usually unnecessary when corn containing the B.t. proteins is planted.
__________________________
MON 89034 × MIR162 seed blend is a product of Monsanto’s research program of fering unique 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