crop-chem-docs/corpus/epa_ppls/524-664.md

# MON 89034 x MIR162 x MON 87411 Seed Blend

- EPA Reg No: **524-664**
- 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 (0.0045%); Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary (vector PV-ZMIR245) for its production in corn (0.011%); 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: 2022-03-01
- Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00664-20220301.pdf

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U.S. ENVIRONMENTAL PROTECTION AGENCY 
Office of Pesticide Programs 
Biopesticides and Pollution Prevention Division (7511P) 
1200 Pennsylvania Ave., N.W. 
Washington, D.C. 20460 
 
EPA Reg. Number: 
 
524-664 
 
 
Date of Issuance: 
 
3/1/2022 
NOTICE OF PESTICIDE: 
 X Registration 
 Reregistration 
 
Term of Issuance: 
Unconditional 
 (under FIFRA, as amended) 
Name of Pesticide Product: 
MON 89034 x MIR162 x MON 
87411 Seed Blen
d 
 
Name and Address of Registrant (include ZIP Code): 
Bayer CropScience LP 
800 North Lindbergh Blvd. 
St. Louis, MO 63167 
 
 
Note: Changes in labeling differing in substance from that accepted in connection with this registration must be submitted to and accepted by the 
Biopesticides and Pollution Prevention Division prior to use of the label in commerce. In any correspondence on this product, always refer to the above EPA 
Registration Number. 
 
On the basis of information furnished by the registrant, the above named pesticide is hereby registered 
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA or the Act). 
 
Registration is in no way to be construed as an endorsement or recommendation of this product by the 
U.S. Environmental Protection Agency (EPA). In order to protect health and the environment, the 
Administrator, on his or her motion, may at any time suspend or cancel the registration of a pesticide in 
accordance with the Act. The acceptance of any name in connection with the registration of a product 
under the Act is not to be construed as giving the registrant a right to exclusive use of the name or to its 
use if it has been covered by others. 
 
This product is unconditionally registered in accordance with FIFRA section 3(c)(5) provided that you 
comply with the terms as described in this notice: 
 
1. The subject registration will automatically expire at midnight on March 1, 2023. 
 
 
 
Signature of Approving Official: 
 
 
 
Alan Reynolds, Team Leader 
Emerging Technologies Branch 
Biopesticides and Pollution Prevention Division (7511P) 
Office of Pesticide Programs
 
 
Date: 
 
 
 3/1/2022 
EPA Form 8570-6

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EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
2. The subject registration is limited to 95% Bacillus thuringiensis Cry1A.105 and Cry2Ab2 
proteins and the genetic material necessary for their production (PV-ZMIR245) in MON 89034 
corn (OECD Unique Identifier MON-89Ø34-3), Bacillus thuringiensis Vip3Aa20 protein and the 
genetic material necessary for its production (pNOV1300) in MIR 162 corn (OECD Unique 
Identifier SYN-IR162-4), and Bacillus thuringiensis Cry3Bb1 protein and DvSnf7 dsRNA and 
the genetic material necessary for their production (PV-ZMIR10871) in MON 87411 corn 
(OECD Unique Identifier MON-87411-9) and 5% non-Bt seed that when planted creates an 
interspersed refuge within the field. 
 
3. Submit and/or cite all data required for registration of your product under FIFRA section 3(c)(5) 
when the Environmental Protection Agency (EPA) requires all registrants of similar products to 
submit such data. 
 
4. 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. 
 
5. Bayer CropScience, LP (Bayer), must commit to do the following Insect Resistance Management 
(IRM) Program, consisting of the following elements: 
 
 Requirements for Bayer to implement an IPM-based stewardship program designed to 
reduce selection pressure for corn rootworm (CRW) resistance. 
 
 Requirements relating to a refuge assurance program for ensuring the correct refuge blend 
percentage. 
 
 Requirements relating to creation of a lepidopteran refuge (consisting of corn that does not 
contain any Bt trait for lepidopteran control) in cotton growing regions in conjunction with 
the planting of MON 89034 x MIR162 x MON 87411 Seed Blend; 
 
 Requirements for Bayer to prepare and require Requirements for Bayer to prepare and 
require MON 89034 x MIR162 x MON 87411 Seed Blend users to sign grower agreements 
that impose binding contractual obligations on growers to comply with the refuge 
requirements. 
 
 Requirements for Bayer to develop, implement, and report to EPA on programs to educate 
growers about IRM requirements. 
 
 Requirements for Bayer to develop, implement, and report to EPA on programs to 
evaluate and promote growers’ compliance with IRM requirements. 
 
 Requirements for Bayer to develop, implement, and report to EPA on monitoring 
programs to evaluate whether there are statistically significant and biologically relevant 
changes in susceptibility to the Cry1A.105, Cry2Ab2, and Vip3Aa20 proteins in the target 
insects.

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EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
 Requirements for Bayer to develop, and if triggered, to implement a remedial action plan 
that would contain measures Bayer would take in the event that any field-relevant insect 
resistance to Cry1A.105, Cry2Ab2, and/or Vip3Aa20 was detected, as well as to report on 
activity under the plan to EPA. 
 
 Requirements for Bayer to investigate reports of unexpected CRW damage to MON 89034 x 
MIR162 x MON 87411 Seed Blend from growers (“performance inquiries”) and sample 
CRW to determine if the insects are resistant to Cry3Bb1 and/or DvSnf7. 
 
 Requirements for Bayer to recommend CRW management options to growers in 
response to cases of unexpected CRW damage to MON 89034 x MIR162 x MON 87411 
Seed Blend. 
 
 Requirements regarding mitigation and notification actions that Bayer would take in 
the event that CRW resistance was detected. 
 
 Requirements for Bayer to maintain, and provide the Agency upon request, the number 
of units sold by state and county, IRM grower agreement results, and substantive changes 
to educational programs. Bayer is required to submit reports within three months of the 
Agency’s request. 
 
 Bag Tag Requirements for MON 89034 x MIR162 x MON 87411 Seed Blend: Seed bags 
and/or bag tags for corn hybrids that contain plant-incorporated protectants produced in 
MON 89034 x MIR162 x MON 87411 Seed Blend must display the registration number and 
active ingredients, and stipulate that growers read the Bayer Stewardship Guide (or 
equivalent guidance) prior to planting these hybrids. The refuge size requirement must be 
displayed on the bag or bag tag in both text and graphic format. 
 
 Requirements for Bayer to submit reports on CRW IPM Stewardship and resistance 
monitoring within the time frames specified in this letter. 
 
a. Integrated Pest Management Stewardship Program 
 
1. Bayer must implement an IPM-based stewardship program for MON 89034 x MIR162 x MON 
87411 Seed Blend. This program must be designed to reduce selection pressure for corn 
rootworm (CRW) resistance by encouraging growers to engage in a multi-year crop rotation 
strategy involving the use of one or more of the following: a non-CRW host crop (e.g., soybean), 
pyramided Bt corn Plant Incorporated Protectants (PIPs), other PIP corn products with different 
modes of action, and/or non-Bt or non-CRW protected Bt corn. As part of the stewardship 
program, Bayer must update the technology use guide/grower guide and other grower 
educational materials to indicate that application of an insecticide to the soil surface, in furrows, 
and/or incorporated into the soil (referred to as “soil applied insecticide,” “soil insecticide” or 
“SAI”) with MON 89034 x MIR162 x MON 87411 Seed Blend is not recommended for control 
of CRW except under limited circumstances and in consultation with extension, crop consultants 
or other local experts. Grower education materials should also state that SAIs should not be 
necessary for CRW control with pyramided CRW trait Bt corn product(s). As part of the

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EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
stewardship program, Bayer must promote the ABSTC/NCGA Best Management Practices 
(BMPs) for CRW control. Implementation of the IPM strategy can include: 
 
 Grower education initiatives or incentives. 
 Outreach to extension and consultant groups. 
 
2. Bayer must submit an annual report to EPA documenting activities conducted under the IPM 
stewardship program. This report must include an anonymous survey of grower practices, 
including adoption levels of the various crop rotation options (if employed) and other elements 
of the stewardship program. Bayer may combine this product with other registered products to 
submit one annual report. The report must be submitted by January 31st each year. 
 
b. Refuge Requirements for MON 89034 x MIR162 x MON 87411 Seed Blend 
 
The following information must be included on the product bag or bag tag as sold per respective region 
and in the Grower Guide: 
 
Corn Belt/Non-Cotton Growing Areas 
 
MON 89034 x MIR162 x MON 87411 Seed Blend contains a Lepidopteran and corn rootworm 
refuge that is “in the bag” and is automatically implemented when the grower plants the product. No 
additional refuge is required when planting this product. 
 
Foliar insecticide treatments for control of European corn borer, corn earworm, southwestern corn 
borer, fall armyworm, black cutworm, western bean cutworm, lesser corn stalk borer, southern corn 
stalk borer, stalk borer and sugarcane borer may be applied only if economic thresholds are reached 
for one or more of these target pests. Foliar insecticide treatments are also permitted for control of 
corn rootworm adults if economic thresholds are reached. Economic thresholds will be determined 
using methods recommended by local or regional professionals (e.g., Extension Service agents, crop 
consultants). 
 
Cotton-Growing Region Refuge Requirements 
 
These refuge requirements do not apply to seed increase/propagation of inbred and 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 registrant per year. Grower 
agreements (also known as stewardship agreements) will specify that growers must adhere to the 
refuge requirements as described in the grower guide/product use guide and/or in supplements to the 
grower guide/product use guide. 
 
In the cotton-growing area where corn earworm is a significant pest: 
 
 A 20% refuge must be planted with non-Bt corn hybrids. 
 
 MON 89034 x MIR162 x MON 87411 Seed Blend and the 20% non-Bt refuge should be 
sown on the same day, or with the shortest window possible between planting dates.

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EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
 External refuges may be planted as an in-field or adjacent (e.g., across the road) refuge or 
planted as a separate block within 1/2 mile of the MON 89034 x MIR162 x MON 87411 
Seed Blend. 
 
 In field refuge options include blocks, perimeter strips (i.e., along the edges or headlands), or 
in-field strips. 
 
 When planting the refuge in strips across the field, refuges must be at least four (4) rows 
wide. 
 
 Foliar insecticide treatments for control of European corn borer, corn earworm, southwestern 
corn borer, fall armyworm, black cutworm, western bean cutworm, lesser corn stalk borer, 
southern corn stalk borer, stalk borer and sugarcane borer 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 consultants). Microbial Bt insecticides must not be applied to non-Bt 
corn refuge plants. 
 
 Cotton-growing areas include the following states: Alabama, Arkansas, Georgia, Florida, 
Louisiana, North Carolina, Mississippi, South Carolina, Oklahoma (only counties of 
Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, and 
Washita), Tennessee (only the counties of Carroll, Chester, Crockett, Dyer, Fayette, Franklin, 
Gibson, Hardeman, Hardin, Haywood, Lake, Lauderdale, Lincoln, Madison, Obion, 
Rutherford, Shelby, and Tipton), Texas (except the counties of Carson, Dallam, Hansford, 
Hartley, Hutchinson, Lipscomb, Moore, Ochiltree, Roberts, and Sherman), Virginia (only the 
counties of Dinwiddie, Franklin City, Greensville, Isle of Wight, Northampton, 
Southampton, Suffolk City, Surrey, and Sussex) and Missouri (only the counties of Dunklin, 
New Madrid, Pemiscot, Scott, and Stoddard). 
 
c. Grower Agreements for MON 89034 x MIR162 x MON 87411 Seed Blend 
 
1. Persons purchasing MON 89034 x MIR162 x MON 87411 Seed Blend must sign a grower 
agreement. The term grower agreement refers to any grower purchase contract, license 
agreement, or similar legal document. 
 
2. The grower agreement and/or specific stewardship documents referenced in the grower 
agreement must clearly set forth the terms of the current IRM program. By signing the grower 
agreement, a grower must be contractually bound to comply with the requirements of the IRM 
program. 
 
3. Bayer must continue to integrate this registration into the current system used for its other Bt 
corn plant- incorporated protectants, which is reasonably likely to assure that persons purchasing 
MON 89034 x MIR162 x MON 87411 Seed Blend will affirm annually that they are 
contractually bound to comply with the requirements of the IRM program. 
 
4. 
Bayer must continue to use its current grower agreement for MON 89034 x MIR162 x MON 
87411 Seed Blend. If Bayer wishes to change any part of the grower agreement or any specific

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EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
stewardship documents referenced in the grower agreement that would affect either the content 
of the IRM program or the legal enforceability of the provisions of the agreement relating to the 
IRM program, then thirty (30) days prior to implementing a proposed change, Bayer must submit 
to EPA the text of such changes to ensure that it is consistent with the terms and conditions of 
this amended registration. 
 
5. Bayer shall maintain records of all MON 89034 x MIR162 x MON 87411 Seed Blend grower 
agreements for a period of three (3) years from December 31st of the year in which the 
agreement was signed. 
 
6. Bayer shall make available to the Agency upon request records of the number of units of MON 
89034 x MIR162 x MON 87411 Seed Blend seed sold or shipped and not returned, and the 
number of such units that were sold to persons who have signed grower agreements for the 
previous growing season. Bayer is required to submit reports within three months of the 
Agency’s request. 
 
7. Bayer must allow a review of the grower agreements and grower agreement records by EPA or 
by a State pesticide regulatory agency if the State agency can demonstrate that confidential 
business information, including names, personal information, and grower license numbers of the 
growers, will be protected. 
 
d. IRM Education and IRM Compliance Monitoring Program for MON 89034 x MIR162 x MON 
87411 Seed Blend in EPA-Designated Cotton Counties 
 
1. Bayer must implement and enhance (as set forth in paragraph 17 of this section) a 
comprehensive, ongoing IRM education program designed to convey to MON 89034 x MIR162 
x MON 87411 Seed Blend users the importance of complying with the IRM program, as well as 
seed blend product performance expectations and guidance to growers on actions to take when 
unexpected damage occurs. The program shall include information encouraging MON 89034 x 
MIR162 x MON 87411 Seed Blend users to pursue optional elements of the IRM program 
relating to refuge configuration and proximity to MON 89034 x MIR162 x MON 87411 Seed 
Blend fields. The education program shall involve the use of multiple media, e.g. face-to-face 
meetings, mailing written materials, EPA-reviewed language on IRM requirements on the bag 
or bag tag, and electronic communications such as by internet, radio, or television commercials. 
The program shall involve at least one written communication annually to each MON 89034 x 
MIR162 x MON 87411 Seed Blend user separate from the grower technical guide. The 
communication shall inform the user of the current IRM requirements and specifically the need 
to plant a lepidopteran refuge in cotton growing regions. Bayer shall coordinate its education 
program with the educational efforts of other registrants and other organizations, such as the 
National Corn Growers Association and state extension programs. 
 
2. Bayer shall revise, and expand as necessary, its education program to take into account the 
information collected through the compliance survey, required under paragraphs 6–9 of this 
section, and from other sources. The changes shall address aspects of grower compliance that are 
not sufficiently high. 
 
3. Upon EPA request, Bayer shall provide copies of grower education materials and information on 
grower education activities including any substantive changes to these materials and activities

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EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
conducted either individually or as part of the industry working group Agricultural 
Biotechnology Stewardship Technical Committee (ABSTC). Bayer is required to submit reports 
within three months of the Agency’s request. The required features of the compliance assurance 
program are described in paragraphs 4–22 of this section. 
 
4. Bayer must implement and improve an ongoing IRM compliance assurance program designed to 
evaluate the extent to which growers purchasing MON 89034 x MIR162 x MON 87411 Seed 
Blend are compliant with the requirement of a 20% refuge for lepidopteran pests in cotton 
growing areas, and that takes such actions as are reasonably needed to assure that growers who 
have not complied with the program either do so in the future or lose their access to Bayer’s Bt 
corn products. Bayer shall coordinate with other Bt corn registrants in improving its compliance 
assurance program and integrate this registration into the current compliance assurance program 
used for its other Bt corn plant-incorporated protectants. Other required features of the program 
are described in paragraphs 5–22 of this section. 
 
5. Bayer must maintain and publicize a phased compliance approach (i.e., a guidance document that 
indicates how it will address instances of non-compliance with the terms of the IRM program 
and general criteria for choosing among options for responding to any non-compliant growers 
after the first year of non-compliance). While recognizing that for reasons of difference in 
business practices there are needs for flexibility between different companies, Bayer must use a 
consistent set of standards for responding to non-compliance. An individual grower found to be 
significantly out of compliance two (2) years in a row would be denied access the next year to 
Bayer’s Bt corn products for which the grower is required to plant a separate structured refuge. 
Similarly, seed dealers who are not fulfilling their obligations to inform/educate growers of their 
IRM obligations will lose their opportunity to sell Bt corn. 
 
6. The IRM compliance assurance program shall include an annual survey, conducted by an 
independent third party, of a statistically representative sample of growers MON 89034 x 
MIR162 x MON 87411 Seed Blend. The survey shall be conducted in odd-numbered years 
beginning in 2023 and shall include growers who plant 100 or more acres of corn in the Southern 
U.S. corn-cotton areas. Bayer may collaborate with other registrants of Bt corn [for example, 
through the industry working group the Agricultural Biotechnology Stewardship Technical 
Committee (ABSTC)] to conduct the survey. 
 
In the U.S. Corn Belt, no anonymous grower survey is required for MON 89034 x MIR162 x 
MON 87411 Seed Blend if Bayer can demonstrate that the industry-wide adoption of integrated 
refuge products (i.e., refuge seed blends) is equal to or greater than 70% of Bt corn acres in the 
Corn Belt. If industry- wide adoption of integrated refuge products (i.e., refuge seed blends) falls 
below 70% of Bt corn acres in the Corn Belt, an anonymous grower survey shall also be 
conducted in this region during the next growing season using a statistically representative 
sample of growers who plant 200 or more acres of corn, and grower surveys shall be continued 
every odd numbered year until the industry-wide adoption of integrated refuge products (i.e., 
refuge seed blends) is again equal to or greater than 70% of Bt corn acres in this region. Bayer 
may collaborate with other registrants of Bt corn (for example, through the industry working 
group the ABSTC) to compile the integrated refuge adoption data and to conduct the surveys. 
 
Alternatively, if Bayer is not a participant of an industry working group (e.g., the ABSTC) and 
Bayer’s sales of integrated refuge products are equal to or greater than 70% of Bayer’s total Bt

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EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
corn sales in the prior year, then no anonymous grower survey is required in the U.S. Corn Belt. 
If Bayer’s sales of integrated refuge products fall below 70% of Bayer’s total Bt corn sales, an 
anonymous grower survey shall also be conducted in this region during the next growing season 
using a statistically representative sample of growers who plant 200 or more acres of corn, and 
grower surveys shall be continued every odd-numbered year until sales of integrated refuge 
products (i.e., refuge seed blends) are again equal to or greater than 70% of Bayer’s total Bt corn 
sales in this region. 
 
 A third party is classified as a party other than the registrant, the grower, or anyone else 
with a direct interest in IRM compliance for Bt corn. 
 
7. The survey shall be designed to provide an understanding of any difficulties growers encounter 
in implementing IRM requirements. An analysis of survey results must include the reasons, 
extent, and potential biological significance of any implementation deviations. 
 
8. The survey shall be designed to obtain grower feedback on the usefulness of specific educational 
tools and initiatives. 
 
9. In years in which the survey is conducted, Bayer shall provide a final written summary of the 
results of the survey (together with a description of the regions, the methodology used, and the 
supporting data) to EPA on or before January 31st of the following year. Bayer shall confer with 
other registrants and EPA on the design and content of the survey prior to its implementation. 
 
10. Bayer shall revise, and expand as necessary, its compliance assurance program to take into 
account the information collected through the compliance survey, required under paragraphs 6–9 
of this section, and from other sources. The changes shall address aspects of grower compliance 
that are not sufficiently high. Bayer must confer with EPA prior to adopting any changes. 
 
11. Bayer shall conduct and enhance an annual on-farm assessment program. Bayer shall train its 
representatives who make on-farm visits with MON 89034 x MIR162 x MON 87411 Seed Blend 
growers to perform assessments of compliance with IRM requirements. There is no minimum 
corn acreage size for this program. Therefore, growers will be selected for this program from 
across all farm sizes. In the event that any of these visits result in the identification of a grower 
who is not in compliance with the IRM program, Bayer shall take appropriate action, consistent 
with its phased compliance approach, to promote compliance. 
 
12. Bayer shall implement a program for investigating legitimate tips and complaints that MON 
89034 x MIR162 x MON 87411 Seed Blend growers are not in compliance with the IRM 
program. Whenever an investigation results in the identification of a grower who is not in 
compliance with the IRM program, Bayer shall take appropriate action, consistent with its 
phased compliance approach. 
 
13. If a grower, who purchases MON 89034 x MIR162 x MON 87411 Seed Blend for planting, was 
specifically identified as not being in compliance during the previous year, Bayer shall visit with 
the grower and evaluate whether the grower is in compliance with the IRM program for the 
current year.

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EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
14. Annually, by January 31st each year, Bayer must provide a report to EPA summarizing the MON 
89034 x MIR162 x MON 87411 Seed Blend compliance assurance program activities and results 
for the prior year and plans for the MON 89034 x MIR162 x MON 87411 Seed Blend 
compliance assurance program for the current year. Within one month of submitting this report 
to EPA, the registrant shall meet with EPA to discuss its findings. The report must inform EPA 
of the number of growers deemed ineligible to purchase Bt corn seed on the basis of continued 
non-compliance with the insect resistance management refuge requirements. Bayer may elect to 
coordinate information with other registrants and report collectively the results of compliance 
assurance programs. 
 
15. Bayer and the seed corn dealers for Bayer must allow a review of the compliance records by 
EPA or by a State pesticide regulatory agency if the State agency can demonstrate that 
confidential business information, including the names, personal information, and grower license 
numbers of the growers, will be protected. 
 
16. Bayer shall revise and expand its existing Compliance Assurance Program to include the 
following elements. The registrant may coordinate with other registrants in designing and 
implementing its Compliance Assurance Program. 
 
17. Bayer will enhance the refuge education program throughout the seed delivery channel: 
 
 Ensure sales representatives, licensees, seed dealers, and growers recognize the 
importance of correct refuge implementation and potential consequences of failure to 
plant the required refuge. 
 
 Implement a “bag tag” that will be attached to all bags of MON 89034 x MIR162 x MON 
87411 Seed Blend seed sold and delivered. The purpose of this bag tag is to remind 
growers MON 89034 x MIR162 x MON 87411 Seed Blend products require 20% 
lepidopteran refuge in cotton growing areas. The PIP product label accepted by EPA 
must include how this information will be conveyed to growers via text and graphics. 
 
18. Bayer will focus the majority of on-farm assessments on regions with the greatest risks for 
resistance: 
 
 Use Bt corn adoption, pest pressure information, and other available information to 
identify regions where the risk of resistance is greatest; 
 
 Focus approximately two-thirds of on-farm assessments on these regions, with the 
remaining assessments conducted across other regions where MON 89034 x MIR162 x 
MON 87411 Seed Blend is used. 
 
19. Bayer will use its available MON 89034 x MIR162 x MON 87411 Seed Blend sales records and 
other information to refine grower lists for on-farm assessments of their compliance with refuge 
requirements:

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EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
 Identify for potential on-farm assessment growers whose sales information indicates they 
have purchased MON 89034 x MIR162 x MON 87411 Seed Blend product but may have 
purchased little or no refuge seed from the registrant, licensee, or affiliated company. 
 
20. Bayer will contract with third parties to perform on-farm assessments of compliance with refuge 
requirements: 
 
 The third-party assessors will conduct all first-time on-farm assessments as well as 
second year on-farm assessments of those growers found out of compliance in a first- 
time assessment. 
 
21. Bayer will annually refine the on-farm assessment program for the MON 89034 x MIR162 x 
MON 87411 Seed Blend product to reflect the adoption rate and level of refuge compliance for 
the product. 
 
22. Bayer will follow up with growers who have been found significantly out of compliance under 
the on-farm assessment program and are found to be back in compliance the following year: 
 
 All growers found to be significantly out of compliance in a prior year will annually be 
sent additional refuge assistance information for a minimum of two years by Bayer, seed 
supplier, or third-party assessor, after completing the assessment process; 
 
 Bayer will conduct follow-up checks on growers found to be significantly out of 
compliance within three years after they are found to be back in compliance; 
 
 A grower found with a second incident of significant non-compliance with refuge 
requirements for the Bt corn product within a five-year period will be denied access to 
Bayer’s Bt corn products the next year. Similarly, seed dealers who are not fulfilling their 
obligations to inform/educate growers of their IRM obligations will lose their opportunity 
to sell Bt corn. 
 
e. Insect Resistance Monitoring and Mi tigation Plan for MON 89034 x MIR162 x MON 87411 
Seed Blend 
 
1. EPA is imposing the following conditions for the Cry1A.105, Cry2Ab2, and Vip3Aa20 toxins 
expressed in MON 89034 x MIR162 x MON 87411 Seed Blend 
 
Bayer will monitor for resistance to Cry1A.105, Cry2Ab2, and Vip3Aa20 expressed in MON 89034 x 
MIR162 x MON 87411 Seed Blend. The monitoring program shall consist of two approaches: (1) 
focused population sampling and laboratory testing; and (2) investigation of reports of less-than 
expected control of labeled insects. Should field-relevant resistance be confirmed, an appropriate 
resistance management action plan will be implemented. 
 
Focused Population Sampling 
 
Bayer shall annually sample and bioassay populations of the key target pests: Ostrinia nubilalis 
(European corn borer; ECB), Diatraea grandiosella (southwestern corn borer; SWCB), and Helicoverpa

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EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
zea (corn earworm; CEW). Sampling for the target pests will be focused in areas identified as those with 
the highest risk of resistance development (e.g., where lepidopteran active Bt hybrids are planted on a 
high proportion of the corn acres, and where the insect species are regarded as key pests of corn). 
Bioassay methods must be appropriate for the goal of detecting field-relevant shifts in population 
response to MON 89034 x MIR162 x MON 87411 Seed Blend and/or changes in resistance allele 
frequency in response to the use of MON 89034 x MIR162 x MON 87411 Seed Blend and, as far as 
possible, should be consistent across sampling years to enable comparisons with historical data. 
 
The number of populations to be collected shall reflect the regional importance of the insect species as a 
pest, and specific collection regions will be identified for each pest. For ECB, a minimum of twelve (12) 
populations across the sampling region will be targeted for collection at each annual sampling. For 
SWCB, the target will be a minimum of six (6) populations. For CEW, the target will be a minimum of 
ten (10) populations. Pest populations should be collected from multiple corn-growing states reflective 
of different geographies and agronomic conditions. To obtain sufficient sensitivity to detect resistance 
alleles before they become common enough to cause measurable field damage, each population 
collection shall attempt to target 400 insect genomes (egg masses, larvae, mated females, and/or mixed-
sex adults), but a successful population collection will contain a minimum of 100 genomes. It is 
recognized that it may not be possible to collect the target number of insect populations or genomes due 
to factors such as natural fluctuations in pest density, environmental conditions, and area-wide pest 
suppression. 
 
The sampling program and geographic range of collections may be modified as appropriate based on 
changes in pest importance and for the adoption levels of MON 89034 x MIR162 x MON 87411 Seed 
Blend. EPA shall be consulted prior to the implementation of such modifications. 
 
Bayer will report to EPA, on or before August 31st of each year, the results of the population sampling 
and bioassay monitoring program. 
 
Any incidence of unusually low sensitivity to the Cry1A.105, Cry2Ab2, and Vip3Aa20 proteins in 
bioassays shall be investigated as soon as possible to understand any field relevance of such a finding. 
Such investigations shall proceed in a stepwise manner until the field relevance can be either confirmed 
or refuted, and results of these shall be reported to EPA annually on or before August 31st. The 
investigative steps will include the following: 
 
i. Re-test progeny of the co llected population to determine whether the unusual bioassay 
response is reproducible and heritable. If it is not reproducible and heritable, no further action 
is required. 
 
ii. If the unusual response is reproducible and heritable, progeny of insects that survive the 
diagnostic concentration will be tested using methods that are representative of exposure to 
MON 89034 x MIR162 x MON 87411 Seed Blend under field conditions. If progeny do not 
survive to adulthood, any suspected resistance is not field relevant and no further action is 
required. 
 
iii. If insects survive steps 1 and 2, resistance is confirmed, and further steps will be taken to 
evaluate the resistance. These steps may include the following:

Page 12 of 22 
EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
a. Determining the nature of the resistance (i.e., recessive or dominant, and the level of 
functional dominance); 
 
b. Estimating the resistance allele fre quency in the original population; 
 
c. Determining whether the resistance alle le frequency is increasing by analyzing field 
collections in subsequent years sampled from the same site where the resistance 
allele(s) was originally collected; 
 
d. Determining the geographic distribution of the resistance allele by analyzing field 
collections in subsequent years from sites surrounding the site where the resistance 
allele(s) was originally collected. 
 
Should field-relevant resistance be confirmed, and the resistance appears to be increasing or spreading, 
Bayer will consult with EPA to develop and implement a case-specific resistance management action 
plan. 
 
Investigation of Reports of Unexpected Levels of Damage by the Target Pests 
 
Bayer will follow up on grower, extension specialist, or consultant reports of unexpected levels of 
damage by the lepidopteran pests listed on the pesticide label. Bayer will instruct its customers to 
contact them if such incidents occur. Bayer will investigate all legitimate reports submitted to the 
company or the company's representatives. 
 
If reports of unexpected levels of damage lead to the suspicion of resistance in any of the key target 
pests (ECB, SWCB, and CEW), Bayer will implement the actions described below, based on the 
following definitions of suspected resistance and confirmed resistance. 
 
Suspected Resistance 
 
EPA defines suspected resistance to mean field reports of unexpected levels of insect feeding damage 
for which: 
 
 The corn in question has been confirmed to be lepidopteran-active Bt corn; 
 
 The relevant plant tissues are expressing the expected level of Bt protein; and 
 
 It has been ruled out that species not susceptible to the protein could be responsible for 
the damage, that no climatic or cultural reasons could be responsible for the damage, and 
 
 That there could be no other reasonable causes for the damage. 
 
EPA does not interpret suspected resistance to mean grower reports of possible control failures or 
suspicious results from annual insect monitoring assays, nor does EPA intend that extensive field studies 
and testing be undertaken to confirm scientifically the presence of insects resistant to MON 89034 x 
MIR162 x MON 87411 Seed Blend in commercial production fields before responsive measures are 
undertaken.

Page 13 of 22 
EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
 
If resistance is suspected, Bayer will instruct growers to do the following: 
 
 Use alternative control measures in MON 89034 x MIR162 x MON 87411 Seed Blend fields 
in the affected region to control the target pest during the immediate growing season. 
 
 Destroy MON 89034 x MIR162 x MON 87411 Seed Blend crop residues in the affected 
region within one (1) month after harvest with a technique appropriate for local production 
practices to minimize the possibility of resistant insects over- wintering and contributing to 
the next season's target pest population. 
 
Additionally, if possible, and prior to the application of alternative control measures or destruction of 
crop residues, Bayer will collect samples of the insect population in the affected fields for laboratory 
rearing and testing. Such rearing and testing shall be conducted as expeditiously as practical. 
 
Confirmed Resistance 
 
EPA defines confirmed resistance to mean, in the case of field reports of unexpected levels of damage 
from the key target pests, that all the following criteria are met: 
 
 There is >30% insect survival and commensurate insect feeding in a bioassay, initiated with 
neonate larvae, that uses methods that are representative of exposure to Bt corn hybrids under 
field conditions (ECB and SWCB only). 
 
 In standardized laboratory bioassays using diagnostic concentrations of the Bt protein suited 
to the target pest in question, the pest exhibits resistance that has a genetic basis and the level 
of survivorship indicates that there may be a resistance allele frequency of ≥ 0.1 in the 
sampled population. 
 
 In standardized laboratory bioassays, the LC50 exceeds the upper limit of the 95% 
confidence interval of the LC50 for susceptible populations surveyed both in the original 
baselines developed for this pest species and in previous years of field monitoring. 
 
Response to Confirmed Resistance in a Key Target Pest as the Cause of Unexpected Levels of Damage 
in the Field 
 
When field resistance is confirmed (as defined above), the following steps will be taken by Bayer: 
 
 EPA will receive notification within 30 days of resistance confirmation; 
 
 Affected customers and extension agents will be notified about confirmed resistance 
within 30 days; 
 
 Monitoring will be increased in the affected area and local target pest populations will 
be sampled annually to determine the extent and impact of resistance;

Page 14 of 22 
EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
 If appropriate (depending on the resistant pest species, the extent of resistance, the timing of 
resistance, and the nature of resistance, and the availability of suitable alternative control 
measures), alternative control measures will be employed to reduce or control target pest 
populations in the affected area. Alternative control measures may include advising 
customers and extension agents in the affected area to incorporate crop residues into the soil 
following harvest to minimize the possibility of over-wintering insects, and/or applications of 
chemical insecticides; 
 
 Unless otherwise agreed with EPA, stop sale and distribution of the relevant lepidopteran-
active Bt corn hybrids in the affected area immediately until an effective local mitigation 
plan, approved by EPA, has been implemented; 
 
 Bayer will develop a case-specific resistance management action plan within 90 days 
according to the characteristics of the resistance event and local agronomic needs. Bayer will 
consult with appropriate stakeholders in the development of the action plan, and the details of 
such a plan shall be approved by EPA prior to implementation; 
 
 Bayer will notify affected parties (e.g., growers, consultants, extension agents, seed 
distributors, university cooperators, and state/federal authorities as appropriate) in the region 
of the resistance situation and approved action plan; and 
 
 In subsequent growing seasons, maintain sales suspension and alternative resistance 
management strategies in the affected region(s) for the Bt corn hybrids that are affected by 
the resistant population until an EPA-approved local resistance management plan is in place 
to mitigate the resistance. 
 
A report on results of resistance monitoring and investigations of damage reports must be 
submitted to EPA, on or before August 31st of each year, for the duration of the registration. 
 
2. EPA is imposing the following conditions for the Cry3Bb1 and DvSnf7 toxins expressed in 
MON 89034 x MIR162 x MON 87411 Seed Blend: 
 
a) Investigation of Reports of Unexpected Levels of Damage (UXD) by Corn Rootworm (CRW): 
Performance Inquiries 
 
1. Bayer is required to investigate "performance inquiries" (i.e., reports of unexpected CRW 
damage to MON 89034 x MIR162 x MON 87411 Seed Blend) from growers. Fields (defined 
as a tract separated by permanent boundaries such as fences, permanent waterways, 
woodlands, croplines not subject to change because of farming practices, or other similar 
features) with unexpected damage that meet both of the criteria below must be subjected to 
the follow-up actions in part 2) below: 
 
a. The affected plants are confirmed to be MON 89034 x MIR162 x MON 87411 Seed 
Blend plants (take leaf samples to determine the presence of the CRW-active Bt 
protein); and

Page 15 of 22 
EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
b. Corn rootworm feeding caused root dama ge with a Node Injury Score (NIS) > 0.5 on 
at least 50% of plants surveyed in a transect sampling of the damaged site(s) within 
the field. 
 
2. Follow-up actions (performance inquir ies). For MON 89034 x MIR162 x MON 87411 Seed 
Blend fields meeting the criteria in part 1) above, Bayer must take the following actions: 
 
a. Collect at least 250 (ideally 500 or mo re) CRW adult individuals from the damaged 
site within the field in question. Collections may be extended to the whole field, if 
necessary to obtain sufficient CRW adult individuals. Collected populations must be 
subjected to the steps described for "investigation of populations of concern" in 
section e(2)(b) below. 
 
 If collections are unsuccessful, visit affected farm or field the following year 
(assuming the grower continues to be a customer and repurchases seed and does 
not rotate the field to a non-host crop) and attempt to collect CRW adults. If 
beetles are not present the subsequent year, see section e(2)(b)(3)(c) below. 
 
b. Review with the grower their CRW management practices and provide CRW 
management recommendations including an assessment of corn fields with similar 
trait(s) adjacent to the affected corn field that are managed by the same grower. 
 
c. Use of single trait products containi ng the CRW traits in MON 89034 x MIR162 x 
MON 87411 Seed Blend in fields with unexpected damage in previous years should 
be discouraged. Recommended management options include, but are not limited to, 
the following: 
 
 Primary option: 
 
o Rotation to non-host crop (e.g., soybean) 
 
 Secondary options: 
 
o Use of pyramided Bt corn products one or more different CRW PIP trait(s); 
 
o Use of different single-CRW PIP traits (i.e., an alternative CRW-active PIP); 
 
o Use of non-Bt or non-CRW protected corn. 
 
 Tertiary options: 
 
o If additional pest management need is determined beyond the secondary 
options listed above, use of the same pyramided Bt corn product is acceptable 
if it is very unlikely that both of the traits are affected (e.g., the affected field 
experienced UXD to one of the traits in the product in the previous year, the 
NIS is less than 1.0, there has been no continuous use of the second trait in the

Page 16 of 22 
EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
product in the affected field, and Bayer has not been informed of resistance to 
the second trait in the county). 
 
o Additional corn rootworm control tools (e.g., soil applied insecticides, 
chemigation) should be considered. 
 
d. If field(s) with UXD is/are planted to a non-host crop (e.g., soybean) the following 
year, then the area will be considered “mitigated” (as discussed in section 
e(2)(b)(3)(d) below) even if subsequent bioassay results show that the population was 
resistant. No further action will be required by Bayer for the UXD case. 
 
3. Bayer must submit an annual report to EPA de tailing activities related to investigations of 
unexpected damage (UXD). This report will include the information from the most recent 
and previous corn growing seasons: 
 
a. Information from the most recent season: 
 
 The number of UXD reports investigated; 
 
 Location (by county and state); 
 
 CRW sampling (number and location of populations collected). 
 
b. Information from the previous season: 
 
 The final disposition of UXD fields from the previous season (i.e., the 
management practices employed in response to UXD if the grower continues to 
be a customer; 
 
 Results from bioassays conducted on CRW populations from UXD fields where 
the primary management option, rotation to non-host crop, was not used. 
 
c. Grower information, such as farm ad dresses or other personally identifiable 
information, or other sensitive business/customer information must not be included in 
this report. This report must be submitted by November 30th each year. 
 
b) Investigation of Population of Concern 
 
1. Bayer must conduct investigations of all CRW populations collected as part of the 
performance inquiry process in section e(2)(a) above. These investigations must include the 
use of an EPA-approved bioassay to determine if sampled CRW populations are resistant to 
any of the CRW PIP toxins in MON 89034 x MIR162 x MON 87411 Seed Blend. 
Acceptable assays must be able to function as diagnostic tools capable of distinguishing 
resistant populations from susceptible ones. Unless previously approved, Bayer must consult 
with EPA on their bioassay prior to its use.

Page 17 of 22 
EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
2. A CRW population will be considered by EPA to be resistant to a CRW PIP toxin if the 
following criteria are met and additional collections and testing are not deemed to be 
necessary (based on part 3) below): 
 
a. An initial performance inqui ry investigation results in a finding of Unexpected Damage; 
and 
 
b. Where green tissues are available and if pl ants are unusually stressed due to agronomic 
and/or environmental factors, Bt protein levels in affected plants are found to be within 
the documented range for that hybrid (if data are available); and 
 
Either (A): On-plant bioassays of insect collections from the UXD fields result in the 
following two statistically relevant comparisons 
 
a. A statistically significant difference in measures of either mortality or sublethal effects 
(growth/development) between the field population and a relevant susceptible control 
population (i.e., one that responds as a typical susceptible field population) on Bt corn 
containing the single PIP and/or lack of a statistically significant difference in measures 
of mortality or sublethal effect between the field population and a resistant positive 
control population
1; and 
 
b. A lack of a statistically significant difference in the same measures of the field population 
raised on Bt corn containing the single PIP and non-Bt corn plants. 
 
Or (B): Sublethal seedling bioassay of insect collections from the UXD fields result in two 
statistically relevant comparisons 
 
i. A statistically significant difference in measures of sublethal effects 
(growth/development) for populations on Bt corn containing the single PIP (normalized 
using non-Bt) seedlings between the field population and a relevant susceptible control 
population where available or historical field populations and/or lack of a statistically 
significant difference in measures between the field population and a resistant positive 
control population
1; and 
 
ii. A lack of a statistically significant difference in the same measures of the field population 
raised on Bt corn seedlings containing the single PIP and non-Bt corn seedlings 
 
Or (C): Diet-based bioassays of insect collections from the UXD fields result in two 
statistically relevant comparisons 
 
i. A statistically significant difference in measures of lethal or sublethal effects 
(growth/development) on diet containing the Bt protein (diagnostic concentration or 
concentration-response measures) between the field population and a relevant susceptible 
control population where available or historical field populations and/or lack of a 
 
1 If a resistant positive control population is not available or accessible, Bayer must consult with EPA prior to initiating 
bioassays and work to develop an appropriate resistant positive control population.

Page 18 of 22 
EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
statistically significant difference in measures between field population and a resistant 
positive control population1; and 
 
ii. Either a lack of a statistically significant difference in the same measures of the field 
population exposed to diet containing the Bt protein (diagnostic concentration) and diet 
not containing the Bt protein and/or lack of a statistically significant difference in 
measures between the field population and a resistant positive control population, or lack 
of a statistically significant concentration and/or lack of a statistically significant 
difference in concentration response between the field and a resistant positive control 
population1. 
 
3. Mitigation, as detailed in section e(2)(c) below, is required for any CRW population that 
meets EPA’s resistance criteria above for any of the CRW traits in MON 89034 x MIR162 x 
MON 87411 Seed Blend, unless the circumstances described below are applicable. 
 
a. To minimize the potential for incorrectly reaching a conclusion of resistance, another 
year of CRW adult collections and additional testing is needed to determine resistance if: 
 
i. The results of the bioassays are inconclusive (e.g., the results of the statistical analysis 
are unclear because of low sample sizes); or 
 
ii. Another reasonable explanation for th e unexpected damage exists (e.g., high pest 
pressure and/or high plant stress). 
 
b. In these cases, Bayer and EPA will discuss and align on next steps before reaching any 
resistance conclusion. 
 
c. If CRW collections are not possible in the current year or subsequent year due to 
successful management practices, then no further investigation is needed. The population 
would be considered "mitigated" meaning, in this case, that the population is suppressed 
or extirpated for the UXD field. However, EPA recommends that Bayer continue to be 
vigilant in areas where CRW populations were successfully mitigated. 
 
d. If a UXD field receives non-host crop (e.g., soybean) rotation the following year as 
described in Section e(2)(a)(2) above, no additional mitigation is subsequently required. 
 
c) Mitigation of CRW Populations Meeting EPA’s Resistance Criteria 
 
1. For any CRW population found to be resistant to one or more of the CRW traits MON 89034 
x MIR162 x MON 87411 Seed Blend under EPA’s criteria described in section e(2)(b) 
above, Bayer must take the following steps: 
 
a) Bayer must inform EPA of all the results of the bioassays as soon as possible, but at least 
within 30 days if measures are triggered. 
 
b) The mitigation action area (MAA) is define d as the growers’ farming operation up to a ½ 
mile radius from the damaged site that produced the resistant population.

Page 19 of 22 
EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
c) Within 30 days of informing EPA of the re sults of the bioassays, Bayer must notify state 
extension agents and crop consultants who operate within the county in which resistance 
was identified. Information shared must include identification of the county in which 
resistance was detected and trait(s) affected. 
 
d) Within the MAA, Baye r must do the following: 
 
i. Prior to finalizing the grower’s seed order for the following season, inform the 
affected grower and other registrants that hold registrations containing the 
compromised trait(s). Bayer must also inform neighboring growers if those growers 
are customers of Bayer. Information shared must include identification of the county 
in which resistance was detected and trait(s) affected; 
 
ii. Discontinue sales/plantin g of products containing the compromised trait(s) without 
additional/alternative (i.e. non-compromised) CRW traits until resistance has been 
demonstrated to have been mitigated. Other Bt registrants selling such products in the 
MAA are encouraged, but cannot be required, to follow suit; 
 
iii. Bayer must monitor the resistant population in the MAA, as long as grower remains a 
customer of the company, until mitigation has been demonstrated as described in part 
e below unless otherwise agreed with EPA. 
 
iv. Require any pyramids sold by Bayer containing the compromised trait(s) be planted 
with a 20% refuge until resistance has been demonstrated to have been mitigated. 
Other Bt corn registrants selling such pyramided products in the MAA are 
encouraged, but cannot be required by this term of registration, to follow suit; 
 
v. For Bayer’s affected customer’s field(s), the mitigation goal is to control the resistant 
CRW population. Within the MAA Bayer shall encourage the use of “Mitigation 
Practices” including: 
 
1. Primary option: Rotation to a non-host crop (e.g., soybean); 
 
2. Secondary options: 
 
a. Use of pyramided Bt corn products with different CRW PIP traits; 
 
b. Only in the case that the resistance de finition for one of the CRW traits in the 
MON 89034 x MIR162 x MON 87411 Seed Blend is not met, continued use 
of the product with a 20% refuge; 
 
c. Use of different single-CRW PIP trai ts (i.e., an alternative CRW active PIP); 
 
d. Use of non- Bt corn or non-CRW protected corn (with/without soil applied 
insecticide).

Page 20 of 22 
EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
3. Tertiary options: 
 
a. If additional pest management n eed is determined beyond the secondary 
options listed above, additional CRW control tools (e.g., soil insecticides, 
seed-applied insecticides, chemigation) should be used. 
 
b. Use of foliar applications to c ontrol adults (when appropriate economic 
thresholds have been met) may be used in conjunction with one or more of the 
above; 
 
e) A resistant CRW population in the MAA will be considered mitigated if one of the 
following criteria is met: 
 
i. Corn fields within the MAA are rotated to a non-host crop (e.g. soybean) for one 
growing season. 
 
ii. After implementation of mitigation practices (part d.v. above), resistance monitoring 
(sampling) is conducted but few CRW are found (i.e., <0.1 adults per plant) and 
environmental conditions (e.g., weather) are unlikely to be responsible for the lack of 
adult CRW presence. If environmental conditions are a factor, then monitoring should 
continue for another season. 
 
iii. After implementation practices (part d.v above), resistance monitoring (sampling) is 
conducted, CRW are found and collected, and bioassays (section e(2)(b)(2) above) 
show that the population susceptibility to the compromised trait(s) has returned to 
baseline levels. 
 
f) The mitigation actions in pa rt d above can be lifted, and growers can resume the use of 
MON 89034 x MIR162 x MON 87411 Seed Blend as a primary tool for CRW 
management in the MAA, only when Bayer demonstrates that successful mitigation as 
described in part e above has been achieved. 
 
2. Based on further research to understand CRW resistance to Bt PIPs, EPA will consider 
refinements to the resistance mitigation program. Such research may include characterizing the 
genetics of resistance (e.g., number of genes, functional dominance, mechanism of resistance, 
and cross-resistance) and the biology of resistant insects (e.g., fitness in the presence and absence 
of the product), and other control tactics. 
 
f. Refuge Assurance Program for MON 89034 x MIR162 x MON 87411 Seed Blend 
 
Bayer must implement a Blended Seed Refuge Assurance Program designed to ensure MON 
89034 x MIR162 x MON 87411 Seed Blend products are formulated with the appropriate rate of 
refuge seeds. The program must include the following four elements: 
 
1. Trait purity check on seed lots prior to blending; 
2. Standard Operating Procedures for the blending process; 
3. Calibration of blending equipment; and 
4. Records and data retention records for seed blend products.

Page 21 of 22 
EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
 
 Calibration records - Bayer will retain documentation for a specified period of time on 
the equipment calibration including the procedure, when it was conducted and the results. 
 
 Blend proportion records (weight and kernel based) - Bayer will retain documentation for 
a specified period of time on the kernel per pound data of the components, the 
calculations to determine the proportions based on weight and the actual weights that are 
blended together to make up an MON 89034 x MIR162 x MON 87411 Seed Blend 
product by seed lot. 
 
All records must be maintained at the Bayer blending facility and must be available for the EPA 
review upon request. 
 
Should Bayer or Bayer's Licensees be notified by the USDA/AMS or State Seed Control 
Officials that your seed blend products have been found to have a lower percentage of the refuge 
component than is represented on the label, they must notify EPA within 30 days. This would 
constitute information reportable under FIFRA section 6(a)(2). 
 
g. Annual Reporting Requirements for MON 89034 x MIR162 x MON 87411 Seed Blend 
 
The following annual reports must be submitted: 
 
1. Compliance Assurance Plan: Compliance Assurance Program activities, including IRM Grower 
Survey results (only for years in which survey was conducted) and on-farm assessment results 
for the prior year and plans for the compliance assurance program for the current year, on or 
before January 31st each year. 
 
2. Insect Resistance Monitoring Results (C ry1A.105, Cry2Ab2, and Vip3Aa20 only): results of 
monitoring and investigations of damage reports, August 31st of each year. 
 
3. IPM Stewardship Program (Cry3Bb1 and DvSnf7 only): Activities conducted under the IPM 
stewardship program, including an anonymous survey of grower practices, adoption levels of the 
various crop rotation options (if employed) and other elements of the stewardship program, on or 
before January 31st of each year. 
 
4. Unexpected Damage Investigations (Cry3Bb1 and DvSnf7 only): Activities related to 
investigations of unexpected damage (UXD), including number and location of UXD cases, 
insect sampling, bioassays, and final disposition of UXD fields from the most recent and 
previous corn growing seasons, on or before November 30th of each year. 
 
 
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

Page 22 of 22 
EPA Reg. No. 524-664 
OPP Case No. 00302998 
 
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 conditions. If you fail to satisfy 
these terms and conditions, the EPA will consider appropriate regulatory action including, among other 
things, cancellation under FIFRA section 6(e). 
 
A stamped copy of the labeling is enclosed for your records. Please also note that the record for this 
product currently contains the following acceptable Confidential Statement of Formula (CSF): 
 
 Basic CSF dated May 14, 2021 
 
If you have any questions, please contact Leslie Paul of my team by phone at (202) 566-1466 or via 
email at paul.leslie@epa.gov. 
 
Sincerely, 
 
 
 
 Alan Reynolds, Team Leader 
Emerging Technologies Branch 
Biopesticides and Pollution 
 Prevention Division (7511P) 
Office of Pesticide Programs 
 
Enclosure

Plant-Incorporated Protectant Label
MON 89034 × MIR162 × MON 87411 Seed Blend
(OECD Unique Identifier: MON-89Ø 34-3 × SYN-IR162-4 × MON-87411-9)
Active Ingredients:
Bacillus thuringiensis Cry1A.105 protein and the genetic material necessary for its
production (vector PV-ZMIR245) in event MON 89034 corn (Unique Identifier MON-
89Ø34-3) .............................................................................................................”0.0045
Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary for its
production (vector PV-ZMIR245) in event MON 89034 corn (Unique Identifier MON-
89Ø34-3) .............................................................................................................”0.0110
Bacillus thuringiensis Vip3Aa20 protein and the genetic material necessary for its
production (vector pNOV1300) in event MIR162 corn (Unique Identifier SYN-IR162-4))
............................................................................................................................... ”0.014
Bacillus thuringiensis Cry3Bb1 protein and the genetic material (vector PV-ZMIR10871)
necessary for its production in corn event MON 87411 (OECD Unique Identifier: MON-
87411-9)«««««««««««««««««««««««««« «”0.0086
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-
9)««««««««««««««««««««««««««««”0.00000037
Other Ingredients:
Phosphomannose isomerase (PMI) marker pro tein and the genetic material necessary
(vector pNOV1300) for its production in the event MIR162 corn ................... ”0.00085
CP4 EPSPS protein (5-enolpyruvylshikimate -3-phosphate synthase) and the genetic
material (vector PV-ZMIR10871) necessary for its production in corn event
MON 87411«......................................................................................................”0.035
*Percentage (wt/wt) on a dry weight basis for whole plant (forage) of MON 89034 ×
MIR162 × MON 87411 plants.
The MON 89034 × MIR162 × MON 87411 seed with th is refuge configuration contains
95% MON 89034 × MIR162 × MON 87411 mixed with 5% non-PIP corn within a single
lot of seed.
03/01/2022
524-664

KEEP OUT OF REACH OF CHILDREN
Caution
EPA Registration No. 524-XXX
EPA Establishment No. 524-MO-002
Bayer CropScience LP
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 commercia l production reflected here and in the terms
and conditions of this registration must b e included in the Technology Use Guide.
MON 89034 × MIR162 × MON 87411 seed blend protects corn crops from leaf, stalk,
and ear damage caused by lepidopteran corn pests listed on this label and root damage
caused by corn rootworm larvae listed on this label. In order to minimize the risk of these
pests developing resistance to MON 89034 × MIR162 × MON 87411 seed blend, an
insect resistance management (IRM) plan must be implemented as defined in the
registration terms and conditions.
This Plant-Incorporated Protectant (PIP) may be combined or produced through
conventional breeding with other registere d PIPs that are similarly approved for use in
combination, through conventional bre eding, with other registered PIPs.
Grower agreements will specify that growers must adhere to the refuge requirements that
will be described on the bag or bag/tag for MON 89034 × MIR162 × MON 87411 seed
blend or other applicable product use documents.
Corn seed bags or bag tags for products containing
MON 89034 × MIR162 × MON 87411 seed blend must include the refuge size
requirement in text and graphical format.
INSECT RESISTANCE MANAGEMENT
Growers are instructed to read information on IRM in the bag and/or bag-tag.

These refuge requirements do not apply to planting of inbred/hybrid corn seed
productions, breeding, and small scale resea rch trials on up to a total of 20,000 acres per
county and up to a combined United State s (U.S.) total of 250,000 acres per PIP active
ingredient per registrant per year.
The seed producer must ensure a minimum o f 5% non-PIP refuge seed is included with
MON 89034 × MIR162 × MON 87411 in each lot of seed corn. The refuge seed in the
seed mixture may not be treated with seed-applied insecticides for corn rootworm (CRW)
control unless the MON 89034 × MIR162 × MON 87411 seed in the seed mixture
receives the same treatment.
The IRM/Grower Guide for MON 89034 × MIR162 × MON 87411 seed blend or
comparable information presented on the product bag or bag-tag, must contain the
following information:
This product is a seed mixture containing MON 89034 × MIR162 × MON 87411 and a
minimum of 5% non-PIP seed that when planted cr eates an interspersed refuge within the
field. There are no requirements for a se parate structured refuge for MON 89034 ×
MIR162 × MON 87411 seed blend when planted in the U.S. corn-growing region,
including Alaska and Hawaii, because the refuge seed is contained within the
bag/container.
T h ei n t e r s p e r s e dr e f u g ec a no n l yb eu s e db yp l a n t i n gs e e dc o r ns p e c i f i c a l l yg e n e r a t e db y
qualified seed producers/ conditioners licensed by the regist rant. Insecticidal treatments
labeled for adult CRW control are discouraged during the time of adult CRW emergence.
The seed mix refuge option for MON 89034 × MIR162 × MON 87411 seed blend
satisfies the refuge requirements in all regions other than in the cotton-growing
region where corn earworm is a significant pest as defined below .
Additional refuge requirements in the cotton-growing region where corn earworm is
a significant pest
In the cotton-growing region where corn earw orm is a significant pest, as defined below,
MON 89034 × MIR162 × MON 87411 seed blend requires the planting of an additional
20% structured refuge (i.e. 20 acres of non-PIP corn for every 80 acres of MON 89034 ×
MIR162 × MON 87411 seed blend planted).
The 20% refuge must be planted with corn hybrids that do not contain PIP technologies
for the control of corn rootworms or corn borers. The refuge and the MON 89034 ×
MIR162 × MON 87411 seed blend should be sown on the same day, or with the shortest
window possible between planting dates to ensu re that corn root development is similar
among varieties. The structured refuge may be planted as an in-field or adjacent (e.g.,
across the road) refuge or planted as a separate block that is within ½ mile of the
MON 89034 × MIR162 × MON 87411 seed blend field. In-field refuge options include

blocks, perimeter strips (i.e., strips around th e 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 from lepidopteran damage by use of non- Bt insecticides if the
population of one or more target Lepidopteran pests of MON 89034 × MIR162 ×
MON 87411 seed blend in the refuge exceeds economic thresholds. In addition, the
refuge can be protected from CRW damage by an appropriate seed treatment or soil
insecticide; however, insecticides labele d for adult CRW control must be avoided in the
refuge during the period of CRW adult e mergence. Economic thresholds will be
determined using methods recommended by l ocal or regional professionals (e.g.,
Extension Service agents, crop consultants).
The cotton-growing region requiring the additional 20% refuge consists of the following
states: Alabama, Arkansas, Georgia, Florida, Louisiana, North Carolina, Mississippi,
South Carolina, Oklahoma (only the coun ties of Beckham, Caddo, Comanche, Custer,
Greer, Harmon, Jackson, Kay, Kiowa, Til lman, and Washita), Tennessee (only the
counties of Carroll, Chester, Crockett, Dyer, Fayette, Franklin, Gibson, Hardeman,
Hardin, Haywood, Lake, Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby, and
Tipton), Texas (except the counties of Cars on, Dallam, Hansford, Hartley, Hutchinson,
Lipscomb, Moore, Ochiltree, Roberts, and S herman), Virginia (only the counties of
Dinwiddie, Franklin City, Greensville, I sle of Wight, Northampton, Southampton,
Suffolk City, Surrey, and Sussex) and Missouri (only the counties of Dunklin, New
Madrid, Pemiscot, Scott, and Stoddard).

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 contain Bayer’s PIPs must be accompanied by either a grower
guide or bag tag which include s information on planting, production, and IRM and notes
that routine applications of insecticides to control these insects are usually unnecessary
when corn containing PIPs are planted.
__________________________
MON 89034 × MIR162 × MON 87411 seed blend 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://www.monsantotechnology.com