crop-chem-docs/corpus/epa_ppls/524-635.md

# 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: 2022-01-26
- Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00635-20220126.pdf

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 
WASHINGTON, D.C. 20460 
 
 
 
 
 
OFFICE OF CHEMICAL SAFETY 
AND POLLUTION PREVENTION 
January 26, 2022 
 
 
 
Edwards Allen, Ph.D. 
Global Regulatory Manager 
Bayer Crop Science LP 
800 N Lindbergh Blvd 
St. Louis, MO 63167 
 
Subject: Pesticide Registrati on Improvement Act (PRIA) Amendment – Conversion of a seed 
increase registration to a commercial use registration 
 Product Name: MON 89034 x MIR162 x MON 87411 
 EPA Registration Number: 524-635 
 Application Date: March 26, 2021 
 OPP Case Number: 00297234 
 
Dear Dr. Allen: 
 
The amendment referred to above, submitted in connection with registration under Section 3(c)(5) of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, is acceptable provided that 
you comply with the updated terms and conditions as described in this letter. 
 
1. The subject registration will automatically expire at midnight on January 31, 2023. 
 
2. The subject registration is limited to 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). 
 
3. Submit and/or cite all data required for registration or registration review of your product 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.

Page 2 of 22 
EPA Reg. No. 524-635 
OPP Case No. 00297234 
 
 
5. Bayer Crop Science, 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 creation of a non-Bt refuge in conjunction with the planting of 
any acreage of MON 89034 x MIR162 x MON 87411 corn. 
 
 Requirements for Bayer to prepare and require MON 89034 x MIR162 x MON 87411 corn 
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. 
 
 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 corn 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 
corn. 
 
 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 corn. Seed bags and/or bag 
tags for corn hybrids that contain plant-incorporated protectants produced in MON 89034 x

Page 3 of 22 
EPA Reg. No. 524-635 
OPP Case No. 00297234 
 
 
MIR162 x MON 87411 corn 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 corn. 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 corn 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 
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 
 
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. 
 
The following information must be included on the product bag or bag-tag as sold per respective region 
and in the Grower Guide:

Page 4 of 22 
EPA Reg. No. 524-635 
OPP Case No. 00297234 
 
 
Common Refuge: A common refuge must be planted for both corn borers and corn rootworm. 
 
i. The common refuge must be planted with corn hybrids that do not contain Bt 
technologies for the control of corn rootworm or corn borers. 
 
ii. The common refuge and MON 89034 x MIR162 x MON 87411 corn must be sown on 
the same day, or with the shortest window possible between planting dates. 
 
iii. If the common refuge is planted on rotated ground then the MON 89034 x MIR162 x 
MON 87411 corn field must also be planted on rotated ground. 
 
iv. If the combined refuge is planted on continuous corn, the MON 89034 x MIR162 x MON 
87411 field may be planted on either continuous or rotated land (option encouraged 
where WCRW rotation resistant biotype may be present). 
 
v. Refuge options are based on the planting of MON 89034 x MIR162 x MON 87411 corn 
in cotton or non-cotton growing regions and the insect pressure in those locations. The 
refuge sizes for these regions are available in Table 1 below: 
 
Table 1. Refuge Requirements for MON 89034 x MIR162 x MON 87411 
 
Region Refuge 
Size 
In-field or 
adjacent 
refuge is 
allowed 
Refuge 
separated 
by up to 
1/2 mile is 
allowed 
Cotton growing 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, VA (only the 
counties of Dinwiddie, Franklin City, Greensville, Isle of Wight, 
Northampton, Southampton, Suffolk City, Surrey, and Sussex) 
20% non-
Bt corn 
Yes Yes 
Cotton growing 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), MO only the counties of Dunkin, New Madrid, Pemiscot, 
Scott, and Stoddard). 
20% non-
Bt corn 
Yes No 
Cotton growing where CEW is not a significant pest and WCRW, 
NCRW and MCRW are not significant: NM, AZ, CA, NV 
5% non-Bt 
corn 
Yes Yes

Page 5 of 22 
EPA Reg. No. 524-635 
OPP Case No. 00297234 
 
 
Region Refuge 
Size 
In-field or 
adjacent 
refuge is 
allowed 
Refuge 
separated 
by up to 
1/2 mile is 
allowed 
Non-cotton growing 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, 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-Bt 
corn 
Yes Yes 
Non-cotton growing where WCRW, NCRW and/or MCRW are 
significant: KS, NE, SD, ND, MN, IA, MO (except the counties of 
Dunkin, 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), 
TX (only the counties of Carson, Dallam, Hansford, Hartley, 
Hutchinson, Lipscomb, Moore, Ochiltree, Roberts, and Sherman) 
5% non-Bt 
corn 
Yes No 
 
vi. If corn rootworms are significant within a region, the structured refuge must be planted as 
an in-field or adjacent refuge using corn hybrids that do not contain Bt technologies for 
the control of corn borers or corn rootworms. 
 
vii. The common refuge may be planted as an in-field or adjacent (e.g., across the road) 
refuge or as a separate block within 1/2 mile of the MON 89034 x MIR162 x MON 
87411 corn field. 
 
viii. In field refuge options include: blocks, perimeter strips (i.e., along the edges or 
headlands), or in-field strips. 
 
ix. When planting the refuge in strips across the field, refuges must be at least four (4) rows 
wide. 
 
x. The common 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 x 
MIR162 x MON 87411 corn 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 labeled for adult CRW control must be avoided in the 
refuge during the period of CRW adult emergence. If insecticides are applied to the 
refuge for control of CRW adults, the same treatment must also be applied in the same 
timeframe to MON 89034 x MIR162 x MON 87411 corn fields. Economic thresholds 
will be determined using methods recommended by local or regional professionals (e.g., 
Extension Service agents, crop consultants).

Page 6 of 22 
EPA Reg. No. 524-635 
OPP Case No. 00297234 
 
 
xi. If corn rootworms 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 1/2 mile of 
the MON 89034 x MIR162 x MON 87411 corn field. The structured refuge must be 
planted with corn hybrids that do not contain Bt technologies for the control of corn 
borers or corn rootworms. Economic thresholds will be determined using methods 
recommended by local or regional professionals (e.g., Extension Service agents, crop 
consultants). 
 
c. Grower Agreements for MON 89034 x MIR162 x MON 87411 
 
1. Persons purchasing MON 89034 x MIR162 x MON 87411 corn 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 corn 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 corn. If Bayer wishes to change any part of the grower agreement or any specific 
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 corn 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 corn 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.

Page 7 of 22 
EPA Reg. No. 524-635 
OPP Case No. 00297234 
 
 
d. IRM Education and IRM Compliance Monitoring Program for MON 89034 x MIR162 x MON 
87411 
 
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 corn users the importance of complying with the IRM program. The program 
shall include information encouraging MON 89034 x MIR162 x MON 87411 corn users to 
pursue optional elements of the IRM program relating to refuge configuration and proximity to 
MON 89034 x MIR162 x MON 87411 corn 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 corn user separate from the grower 
technical guide. The communication shall inform the user of the current IRM requirements. 
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 
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 corn 
are compliant with the IRM program, 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.

Page 8 of 22 
EPA Reg. No. 524-635 
OPP Case No. 00297234 
 
 
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 corn. 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 corn 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 
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.

Page 9 of 22 
EPA Reg. No. 524-635 
OPP Case No. 00297234 
 
 
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 corn 
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 corn 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 corn 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. 
 
14. Annually, by January 31st each year, Bayer must provide a report to EPA summarizing the MON 
89034 x MIR162 x MON 87411 compliance assurance program activities and results for the 
prior year and plans for the MON 89034 x MIR162 x MON 87411 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.

Page 10 of 22 
EPA Reg. No. 524-635 
OPP Case No. 00297234 
 
 
 
 Implement a “bag tag” that will be attached to all bags of MON 89034 x MIR162 x MON 
87411 seed sold and delivered. The purpose of this bag tag is to remind growers that 
MON 89034 x MIR162 x MON 87411 products require 50% 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 is used. 
 
19. Bayer will use its available MON 89034 x MIR162 x MON 87411 sales records and other 
information to refine grower lists for on-farm assessments of their compliance with refuge 
requirements: 
 
 Identify for potential on-farm assessment growers whose sales information indicates they 
have purchased MON 89034 x MIR162 x MON 87411 corn 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 corn 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;

Page 11 of 22 
EPA Reg. No. 524-635 
OPP Case No. 00297234 
 
 
 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 
 
1. EPA is imposing the following conditions for the Cry1A.105, Cry2Ab2, and Vip3Aa20 toxins 
expressed in MON 89034 x MIR162 x MON 87411 
 
Bayer will monitor for resistance to Cry1A.105, Cry2Ab2, and Vip3Aa20 expressed in MON 89034 x 
MIR162 x MON 87411. 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 
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 corn and/or changes in resistance allele frequency in 
response to the use of MON 89034 x MIR162 x MON 87411 corn 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 corn. 
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.

Page 12 of 22 
EPA Reg. No. 524-635 
OPP Case No. 00297234 
 
 
 
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 87411corn 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: 
 
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.

Page 13 of 22 
EPA Reg. No. 524-635 
OPP Case No. 00297234 
 
 
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 MON87411corn in commercial production fields before responsive measures are undertaken. 
 
If resistance is suspected, Bayer will instruct growers to do the following: 
 
 Use alternative control measures in MON 89034 x MIR162 x MON 87411 corn fields in the 
affected region to control the target pest during the immediate growing season. 
 
 Destroy MON 89034 x MIR162 x MON 87411 corn 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.

Page 14 of 22 
EPA Reg. No. 524-635 
OPP Case No. 00297234 
 
 
 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; 
 
 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.

Page 15 of 22 
EPA Reg. No. 524-635 
OPP Case No. 00297234 
 
 
2. EPA is imposing the following conditions for the Cry3Bb1 and DvSnf7 toxins expressed in 
MON 89034 x MIR162 x MON 87411: 
 
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 corn) 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 corn 
plants (take leaf samples to determine the presence of the CRW-active Bt protein); 
and 
 
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 corn 
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 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)

Page 16 of 22 
EPA Reg. No. 524-635 
OPP Case No. 00297234 
 
 
 
 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 
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.

Page 17 of 22 
EPA Reg. No. 524-635 
OPP Case No. 00297234 
 
 
 
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. 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. 
 
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 
 
i. 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 
 
ii. 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 
 
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. 524-635 
OPP Case No. 00297234 
 
 
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 population1; 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 
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, 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.

Page 19 of 22 
EPA Reg. No. 524-635 
OPP Case No. 00297234 
 
 
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 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. 
 
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);

Page 20 of 22 
EPA Reg. No. 524-635 
OPP Case No. 00297234 
 
 
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 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). 
 
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 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,

Page 21 of 22 
EPA Reg. No. 524-635 
OPP Case No. 00297234 
 
 
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. Annual Reporting Requirements for MON 89034 x MIR162 x MON 87411 
 
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 
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 label is enclosed for your records. A previously approved Confidential Statement 
of Formula dated May 10, 2016 is on file for this product.

Page 22 of 22 
EPA Reg. No. 524-635 
OPP Case No. 00297234 
 
 
 
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
(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.
01/26/2022
524-635

KEEP OUT OF REACH OF CHILDREN
Caution
EPA Registration No. 524-635
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 ofthis registration must b e 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 earworm, and root damage caused by corn
rootworm. In order to minimize the risk of these pests developing resistance to
MON 89034 × MIR162 × MON 87411 corn, an insect resistance management (IRM)
plan must be implemented which include s planting of a structured refuge.
This plant-incorporated protectant (PIP) ma y be combined through conventional breeding
with other registered PIPs that are similarl y approved for use in combination, through
conventional breeding, with other registered PIPs.
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.
Several options for deployment of the 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 growing 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, Che ster, 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, Pemisco t,S c o tt, 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, Che ster, 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 significant with in a region, the structured refuge must be
planted as an in-field or adjacent refug e using corn hybrids that do not contain PIP
technologies for the control of corn borers o r CRW. The structured refuge can be planted
as a block within or adjacent (e.g., across the road) to the MON 89034 × MIR162 ×

MON 87411 field, perimeter strips (i.e., strip s 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 fro m lepidopteran damage by use of non- B.t.
insecticides if the population of one or more target lepidopteran pests of MON 89034 ×
MIR162 × MON 87411 in the refuge exceeds economic threshold. In addition, the refuge
can be protected from CRW damage by an approp riate seed treatment 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 regional professionals (e.g., Extension Service
agents, crop consultants). A schematic of one common refuge 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 refuge 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 ag ents, 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
ч½ 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 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 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://www.monsantotechnology.com