305 lines
15 KiB
Markdown
305 lines
15 KiB
Markdown
# MON 89034 X MIR162 X MON 87411 INSECT-PROTECTED, HERBICIDE-TOLERANT CORN
|
||
|
||
- EPA Reg No: **524-635**
|
||
- 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 (0.0027%); Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary (vector PV-ZMIR245) for its production in corn (0.0071%); dsRNA transcript comprising a DvSnf7 inverted repeat sequence derived from western corn rootworm (Diabrotica virgifera) and the genetic material necessary for its production MON 87411 corn (3.7e-07%); Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its procuction (vector PV -ZMIR10871) in corn event MON 87411 (0.0086%); Bacillus thuringiensis Vip3Aa20 protein encoded by vector pNOV1300 in event MIR162 corn (SYN-IR162-4), % dw (0.014%)
|
||
- Label accepted: 2026-08-17
|
||
- Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00635-20260817.pdf
|
||
|
||
---
|
||
August 17, 2026
|
||
|
||
Edwards Allen, Ph.D.
|
||
Global Regulatory Manager
|
||
Bayer CropScience LLC
|
||
700 Chesterfield Parkway West
|
||
Chesterfield, MO 63017
|
||
|
||
Subject:
|
||
PRIA (Pesticide Registration Improvement Act) B900 Amendments – Addition of
|
||
time-limited refuge requirement for southwestern corn borer management in
|
||
specified areas of New Mexico and Arizona and associated label updates.
|
||
Product Names: See Table 1 below.
|
||
EPA Registration Numbers: See Table 1 below.
|
||
EPA Receipt Date: July 07, 2026
|
||
OPP Case Numbers: See Table 1 below.
|
||
|
||
Dear Dr. Allen:
|
||
|
||
The amendments referenced above and described below, submitted in connection with
|
||
registration under Section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act
|
||
(FIFRA), are acceptable. The following products are subject to these amendments:
|
||
|
||
Table 1. List of Amended Products
|
||
Product Name EPA
|
||
Registration
|
||
No.
|
||
OPP Action Case
|
||
No.
|
||
Lepidopteran Active Toxins
|
||
MON 89034 x MIR162 524-625 00702260 Cry1A.105, Cry2Ab2,
|
||
Vip3Aa20
|
||
MON 89034 x MIR162
|
||
x MON 87411
|
||
524-635 00702259 Cry1A.105, Cry2Ab2,
|
||
Vip3Aa20, Cry3Bb1, DvSnf7
|
||
|
||
For each of the products listed in Table 1, the refuge requirements are modified as follows:
|
||
|
||
x Growers in Hidalgo Co., NM (near Antelope Wells and Animas) and Cochise Valley in
|
||
Arizona (Cochise Co. south of Graham Co., AZ) are not required to plant a non-Bt refuge
|
||
for the 2027 and 2028 growing seasons.
|
||
|
||
This approval does not affect any of the other terms or conditions that were previously
|
||
imposed on these registrations. You continue to be subject to existing terms or conditions on
|
||
your registrations and any deadlines connected with them, as described in EPA’s Registration
|
||
|
||
Page 2 of 2
|
||
EPA Registration Nos. 524-625 and 524-635
|
||
Action Case Nos. 00702260 and 00702259
|
||
|
||
|
||
|
||
Notices for these products.
|
||
|
||
Should you wish to add/retain a reference to your company’s website on your label(s), 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(s)
|
||
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 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 EPA find or if it is brought to our attention
|
||
that a website contains statements or claims substantially differing from statements or claims
|
||
made in connection with obtaining a FIFRA section 3 registration, the website will be referred
|
||
to EPA’s Office of Enforcement and Compliance Assurance.
|
||
|
||
Stamped copies of your labels are enclosed for your records. This labeling supersedes all
|
||
previously accepted 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.
|
||
|
||
Your release for shipment of these products constitutes acceptance of these terms. If these
|
||
terms are not complied with, these registrations will be subject to cancellation in accordance
|
||
with FIFRA section 6.
|
||
|
||
The following approved Confidential Statements of Formula (CSF) are on file for your products:
|
||
|
||
x 524-625: Basic CSF Dated April 1, 2020
|
||
x 524-635: Basic CSF Dated May 10, 2016
|
||
|
||
If you have any questions, please contact David Linz by email at linz.david@epa.gov or by
|
||
phone at (513) 569-7538.
|
||
|
||
Sincerely,
|
||
|
||
|
||
|
||
Alan Reynolds, Product Manager 94
|
||
Emerging Technologies Branch
|
||
Biopesticides and Pollution
|
||
Prevention Division (7511M)
|
||
Office of Pesticide Programs
|
||
|
||
Enclosures: Product Label Stamped “Acceptable”
|
||
Digitally signed by
|
||
ALAN REYNOLDS
|
||
Date: 2026.08.17
|
||
13:43:45 -04'00'
|
||
|
||
Plant-Incorporated Protectant Label
|
||
MON 89034 × MIR162 × MON 87411
|
||
(OECD Unique Identifier: MON-89Ø34-3 × SYN-IR162-4 × MON-87411-9)
|
||
Active Ingredients:
|
||
Bacillus thuringiensis Cry1A.105 protein and the geneti c material necessary for its
|
||
production (vector PV-ZMIR245) in even t MON 89034 corn (Unique Identifier MON-
|
||
|
||
Bacillus thuringiensis Cry2Ab2 protein and the geneti c material necessary for its
|
||
production (vector PV-ZMIR245) in even t MON 89034 corn (Unique Identifier MON-
|
||
|
||
Bacillus thuringiensis Vip3Aa20 protein and the gene tic material necessary for its
|
||
production (vector pNOV1300) in event MIR162 corn (Unique Identifier SYN-IR162-4))
|
||
|
||
Bacillus thuringiensis Cry3Bb1 protein and the genetic material (vector PV-ZMIR10871)
|
||
necessary for its production in corn even t MON 87411 (OECD Unique Identifier: MON-
|
||
«««««««««««««««««««««««««« «
|
||
dsRNA transcript comprising a DvSnf7 inverted repeat sequence derived from Diabrotica
|
||
virgifera virgifera , and the genetic material necess ary for its production (vector PV-
|
||
ZMIR10871) in MON 87411 corn (OECD Unique Identifier MON-87411-
|
||
««««««««««««««««««««««««««««
|
||
Other Ingredients:
|
||
Phosphomannose isomerase (PMI ) marker protein and the ge netic material necessary
|
||
YHFWRU S129 IRU LWV SURGXFWLRQ LQ WKH HYHQW 0,5 FRUQ
|
||
CP4 EPSPS protein (5-enolpyruvylshikimate- 3-phosphate synthase) and the genetic
|
||
material (vector PV-ZMIR10871) necess ary for its production in corn event
|
||
021 «
|
||
*Percentage (wt/wt) on a dry weight basis for whole pl ant (forage) of MON 89034 ×
|
||
MIR162 × MON 87411 plants.
|
||
08/17/2026
|
||
524-635
|
||
|
||
KEEP OUT OF REACH OF CHILDREN
|
||
Caution
|
||
EPA Registration No. 524-635
|
||
EPA Establishment No. 524-MO-002
|
||
Bayer CropScience LLC
|
||
800 North Lindbergh Blvd.
|
||
St Louis, MO 63167
|
||
NET CONTENTS__________
|
||
DIRECTIONS FOR USE
|
||
It is a violation of Federal law to use this product in any manner inconsistent with its
|
||
labeling. Information regarding commercial pr oduction reflected here and in the terms
|
||
and conditions ofthis registration must be included in the Technology Use Guide.
|
||
MON 89034 × MIR162 × MON 87411 protects corn plants from leaf, stalk, and ear
|
||
damage caused by corn borers and corn e arworm, and root damage caused by corn
|
||
rootworm. In order to minimize the risk of these pests devel oping resistance to
|
||
MON 89034 × MIR162 × MON 87411 corn, an in sect resistance management (IRM)
|
||
plan must be implemented which includes planting of a structured refuge.
|
||
This plant-incorporated protectant (PIP) may be combined through conventional breeding
|
||
with other registered PIPs that are simila rly approved for use in combination, through
|
||
conventional breeding, with other registered PIPs.
|
||
Growers in Hidalgo Co, NM (near Antelope Wells and Animas) and Cochise Valley in
|
||
Arizona (Cochise Co. South of Graham Co, AZ) are not required to plant a non-Bt refuge
|
||
for the 2027 and 2028 growing seasons.
|
||
These refuge requirements do not apply to planting of inbred/hybrid corn seed
|
||
productions, breeding, and small scale research trials on up to a total of 20,000 acres per
|
||
county and up to a combined United States (U.S.) total of 250,000 ac res per PIP active
|
||
ingredient per registrant per year.
|
||
Several options for deployment of th e refuge for MON 89034 × MIR162 × MON 87411
|
||
are available to growers. These options are based on the planting of MON 89034 ×
|
||
MIR162 × MON 87411 in cotton or non-cotton grow ing regions and the insect pressure
|
||
present in those locations. The refuge sizes for these regions are either 5% (i.e. 5 acres of
|
||
non-PIP corn for every 95 acres MON 89034 × MIR162 × MON 87411 corn planted) or
|
||
|
||
20% (20 acres of non-PIP corn for every 80 acres of MON 89034 × MIR162 ×
|
||
MON 87411 corn planted), and are presented in the table below:
|
||
Region Refuge size
|
||
In-field or
|
||
adjacent
|
||
refuge
|
||
Refuge
|
||
separated by
|
||
up to ½ mile
|
||
Cotton growing states where CEW is a significant
|
||
pest and WCRW, NCRW and MCRW are not
|
||
significant: AR, NC, SC, GA, FL, TN (only the
|
||
counties of Carroll, Chester, Crockett, Dyer,
|
||
Fayette, Franklin, Gibson, Hardeman, Hardin,
|
||
Haywood, Lake, Lauderdale, Lincoln, Madison,
|
||
Obion, Rutherford, Shelby, and Tipton), AL, MS,
|
||
LA, and VA (only the counties of Dinwiddie,
|
||
Franklin City, Greensville, Isle of Wight,
|
||
Northampton, Southampton, Suffolk City, Surrey,
|
||
and Sussex)
|
||
20% non-PIP
|
||
corn Yes Yes
|
||
Cotton growing states where CEW is a significant
|
||
pest and WCRW, NCRW and/or MCRW are
|
||
significant: TX (except the counties of Carson,
|
||
Dallam, Hansford, Hartley, Hutchinson,
|
||
Lipscomb, Moore, Ochiltree
|
||
Roberts, and Sherman), OK (only the counties of
|
||
Beckham, Caddo, Comanche, Custer, Greer,
|
||
Harmon, Jackson, Kay, Kiowa, Tillman, and
|
||
Washita), and MO (only the counties of Dunklin,
|
||
New Madrid, Pemiscot, Scott, and Stoddard)
|
||
20% non-PIP
|
||
corn Yes No
|
||
Cotton growing states where CEW is not a
|
||
significant pest and WCRW, NCRW and MCRW
|
||
are not significant: NM, AZ, CA, NV
|
||
5% non-PIP
|
||
corn Yes Yes
|
||
Non-cotton growing states where WCRW, NCRW
|
||
and MCRW are not significant: OR, WA, ID, MT,
|
||
WY, UT, VA (except the counties of Dinwiddie,
|
||
Franklin City, Greensville, Isle of Wight,
|
||
Northampton, Southampton, Suffolk City, Surrey,
|
||
and Sussex) , WV, PA, MD, DE, CT, RI, NJ, NY,
|
||
ME, MA, NH, VT, HI, AK and TN (except the
|
||
counties of Carroll, Chester, Crockett, Dyer,
|
||
Fayette, Franklin, Gibson, Hardeman, Hardin,
|
||
Haywood, Lake, Lauderdale, Lincoln, Madison,
|
||
Obion, Rutherford, Shelby, and Tipton)
|
||
5% non-PIP
|
||
corn Yes Yes
|
||
Non-cotton growing states where WCRW, NCRW
|
||
and/or MCRW are significant: KS, NE, SD, ND,
|
||
MN, IA, MO (except the counties of Dunklin,
|
||
New Madrid, Pemiscot, Scott, and Stoddard), IL,
|
||
WI, MI, IN, OH, KY, CO, OK (except the
|
||
counties of Beckham, Caddo, Comanche, Custer,
|
||
Greer, Harmon, Jackson, Kay, Kiowa, Tillman,
|
||
and Washita), and TX (only the counties of
|
||
Carson, Dallam, Hansford, Hartley, Hutchinson,
|
||
Lipscomb, Moore, Ochiltree, Roberts, and
|
||
Sherman)
|
||
5% non-PIP
|
||
corn Yes No
|
||
If corn rootworms (CRW) are si gnificant within a region, the structured refuge must be
|
||
planted as an in-field or adjacent refuge using corn hybrids that do not contain PIP
|
||
|
||
technologies for the control of corn borers or CRW. The structured refuge can be planted
|
||
as a block within or adjacent (e.g., acro ss the road) to the MON 89034 × MIR162 ×
|
||
MON 87411 field, perimeter strips (i.e., strips around the field), or in-field strips. If
|
||
perimeter or in-field strips are implemented, the strips must be at least 4 consecutive rows
|
||
wide. The refuge can be protected fr om lepidopteran dama ge by use of non-Bt
|
||
insecticides if the population of one or mo re target lepidopteran pests of MON 89034 ×
|
||
MIR162 × MON 87411 in the refuge exceeds economic threshold. In addition, the refuge
|
||
can be protected from CRW dama ge by an appropriate seed trea tment or soil insecticide;
|
||
however, insecticides labeled for adult CRW control should be avoided in the refuge
|
||
during the period of CRW adult emergence . Economic thresholds will be determined
|
||
using methods recommended by local or regi onal professionals (e.g., Extension Service
|
||
agents, crop consultants). A schematic of one common ref uge deployment option is
|
||
shown below:
|
||
Structured Refuge
|
||
If CRW are not significant within a region, the structured refuge may be planted as an in-
|
||
field or adjacent refuge, or as a separate block that is within ½ mile of the MON 89034 ×
|
||
MIR162 × MON 87411 field. The structured ref uge must be planted with corn hybrids
|
||
that do not contain PIP technologies for the control of corn borers or CRW. Economic
|
||
thresholds will be determined using methods recommended by local or regional
|
||
professionals (e.g., Extension Service agents , crop consultants). A schematic of one
|
||
refuge option with the refuge planted within a ½ mile of the MON 89034 × MIR162 ×
|
||
MON 87411 field is shown below:
|
||
Separated Structured Refuge
|
||
MON 89034 ×
|
||
MIR162 ×
|
||
MON 87411
|
||
Refuge
|
||
Non-PIP corn
|
||
MON 89034 ×
|
||
MIR162 ×
|
||
MON 87411
|
||
ч ½ mile
|
||
Refuge
|
||
Non-PIP corn
|
||
|
||
Corn Insects Controlled or Suppressed
|
||
European corn borer (ECB) Ostrinia nubilalis
|
||
Southwestern corn borer (SWCB) Diatraea grandiosella
|
||
Southern cornstalk borer (SCSB) Diatraea crambidoides
|
||
Corn earworm (CEW) Helicoverpa zea
|
||
Fall armyworm (FAW) Spodoptera frugiperda
|
||
Stalk borer Papaipema nebris
|
||
Sugarcane borer (SCB) Diatraea saccharalis
|
||
Beet armyworm Spodoptera exigua
|
||
True armyworm Pseudelatia unipuncta
|
||
Black cutworm Agrotis ipsilon
|
||
Western bean cutworm (WBC) Striacosta albicosta
|
||
Lesser cornstalk borer Elasmopalpus lignosellus
|
||
Dingy Cutworm Feltia jaculifera
|
||
Western corn rootworm (WCRW) Diabrotica virgifera virgifera
|
||
Mexican corn rootworm (MCRW) Diabrotica virgifera zeae
|
||
Northern corn rootworm (NCRW) Diabrotica barberi
|
||
Sales of corn hybrids that c ontain Bayer’s PIPs must be accompanied by either a grower
|
||
guide or bag tag which includes informat ion on planting, production, and IRM and notes
|
||
that routine applications of insecticides to control these insects are usually unnecessary
|
||
when corn containing the PIPs are planted.
|
||
__________________________
|
||
MON 89034 × MIR162 × MON 87411 is a product of Bayer’s research program offering unique 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://cs.bayerpatents.bayer.com
|