crop-chem-docs/corpus/epa_ppls/524-632.md

# MON 89034 X TC1507 X MON 87411 X DAS-59122-7

- EPA Reg No: **524-632**
- Registrant: BAYER CROPSCIENCE, LLC
- Signal word: Caution
- Active ingredients: Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production (plasmid insert PHI8999) in corn (0.00096%); Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for their production in corn (0.012%); Bacillus thuringiensis Cry1A.105 protein and genetic material necessary (vector PV-ZMIR245) for its production in corn (0.0088%); Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary (vector PV-ZMIR245) for its production in corn (0.0048%); 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 (4.4e-07%); Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its procuction (vector PV -ZMIR10871) in corn event MON 87411 (0.0041%)
- Label accepted: 2022-06-14
- Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00632-20220614.pdf

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EPA Form 8570-6 
 
 
U.S. ENVIRONMENTAL PROTECTION AGENCY 
Office of Pesticide Programs 
Biopesticides and Pollution Prevention Division (7511M) 
1200 Pennsylvania Ave., N.W. 
Washington, D.C. 20460 
 
EPA Reg. Number: 
 
524-632 
 
Date of Issuance: 
 
6/14/2022 
NOTICE OF PESTICIDE: 
 ☒Registration 
 ☐Reregistration 
 
Term of Issuance: 
Unconditional 
 (under FIFRA, as amended) 
Name of Pesticide Product: 
MON 89034 x TC1507 x MON 87411 
x DAS-59122-7 
 
Name and Address of Registrant (include ZIP Code): 
Bayer CropScience LP 
700 Chesterfield Parkway West 
Chesterfield, Missouri 63017 
 
 
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 following terms: 
 
1. The subject registration will automatically expire at midnight on June 30, 2023. 
Signature of Approving Official: 
 
 
 
 
Alan Reynolds, Team Leader 
Emerging Technologies Branch 
Biopesticides and Pollution Prevention Division (7511P) 
 
Date: 
 
 
 6/14/2022

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EPA Reg. No. 524-632 
OPP ACC No. 00308646 and 00308662 
2. The subject registration will be limited to Bacillus thuringiensis Cry1A.105 and Cry2Ab2 proteins and 
the genetic material necessary for their production (vector PV-ZMIR245) in MON 89034 corn (OECD 
Unique Identifier: MON-89Ø34-3), Bacillus thuringiensis Cry1F protein and the genetic material 
necessary for its production (vector PHP8999) in TC1507 corn (OECD Unique Identifier: DAS-Ø15Ø7-
1), Bacillus thuringiensis Cry34Ab1/Cry35Ab1 proteins and the genetic material necessary for their 
production (vector PHP17662) in DAS-59122-7 corn (OECD Unique Identifier: DAS-59122-7), DvSnf7 
dsRNA [Double-stranded ribonucleic acid transcript comprising a DvSnf7 inverted repeat sequence 
derived from western corn rootworm (Diabrotica virgifera virgifera)], and Bacillus thuringiensis 
Cry3Bb1 protein and the genetic material necessary for their production (vector PV-ZMIR10871) in 
MON 87411 corn (OECD Unique Identifier: MON-87411-9) corn for use in field corn. 
 
3. Submit/cite all data required for registration of your product under FIFRA section 3(c)(5) when the 
Environmental Protection Agency (EPA) requires 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 creation of a non-PIP refuge in conjunction with the planting of any 
acreage of MON 89034 x TC1507 x MON 87411 x DAS-59122-7 corn; 
 
 Requirements for Bayer to prepare and require MON 89034 x TC1507 x MON 87411 x DAS-
59122-7 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 Cry1F 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 Cry1F 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 
TC1507 x MON 87411 x DAS-59122-7 corn from growers (“performance inquiries”) and

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EPA Reg. No. 524-632 
OPP ACC No. 00308646 and 00308662 
sample CRW to determine if the insects are resistant to Cry34/35Ab1, DvSnf7 dsRNA, or 
Cry3Bb1. 
 
 Requirements for Bayer to recommend CRW management options to growers in response to 
cases of unexpected CRW damage to MON 89034 x TC1507 x MON 87411 x DAS-59122-7 
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 TC1507 x MON 87411 x DAS-59122-7 corn. Seed bags 
and/or bag tags for corn hybrids that contain plant- incorporated protectants produced in MON 
89034 x TC1507 x MON 87411 x DAS-59122-7 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, on or before January 31
st of each year, to submit reports on Cry1A.105, 
Cry2Ab2, and Cry1F resistance monitoring. 
 
a. Integrated Pest Management Stewardship Program 
 
1. Bayer must implement an IPM-based stewardship program for MON 89034 x TC1507 x MON 87411 x 
DAS-59122-7 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 PIP 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 TC1507 x MON 87411 x DAS-59122-7 
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.

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EPA Reg. No. 524-632 
OPP ACC No. 00308646 and 00308662 
 
b. Refuge Requirements for MON 89034 x TC1507 x MON 87411 x DAS-59122-7 
 
The following information must be included on the product bag or bag-tag as sold per respective region and 
in the Grower Guide: 
These refuge requirements do not apply to planting of inbred/hybrid corn seed productions, breeding, and 
small-scale research trials on up to a total of 20,000 acres per county and up to a combined United States 
(U.S.) total of 250,000 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. 
 
Common Refuge 
 
A common refuge must be planted for both corn borers and corn rootworm. The common refuge: 
 
 Must be planted with corn hybrids that do not contain PIP technologies for the control of corn rootworm 
or corn borers. 
 
 MON 89034 x TC1507 x MON 87411 x DAS-59122-7 corn and the non-PIP refuge should be sown on 
the same day, or with the shortest window possible between planting dates to ensure that corn root 
development is similar among varieties. 
 
 If the refuge is planted on rotated ground, then the MON 89034 x TC1507 x MON 87411 x DAS-59122-
7 corn must also be planted on rotated ground. 
 
 If the combined refuge is planted on continuous corn, the MON 89034 x TC1507 x MON 87411 x DAS-
59122-7 field may also be planted on either continuous or rotated land (option encouraged where 
WCRW rotation resistant biotype may be present). 
 
 Refuge options are based on the planting of MON 89034 x TC1507 x MON 87411 x DAS-59122-7 corn 
in cotton or non-cotton growing regions and the insect pressure present in those locations. The refuge 
sizes for these regions are either 20% in cotton growing regions or 5% in non-cotton growing regions 
(refer to the table below). 
 
 In regions where corn rootworm is a significant pest: 
 
i. The common refuge must be planted as an in-field or adjacent refuge using corn hybrids that do not 
contain PIP technologies for the control of corn borers or corn rootworms. 
 
ii. The common refuge can be planted as: 
 
a. A block within or adjacent (e.g., across the road) to the MON 89034 x TC1507 x MON 87411 x 
DAS-59122-7 corn field; 
b. Perimeter strips (i.e., along the edges or headlands); or 
c. In-field strips.

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EPA Reg. No. 524-632 
OPP ACC No. 00308646 and 00308662 
iii. If perimeter or in-field strips are implemented as refuge, the strips must be at least four (4) rows 
wide. 
 
 In regions where corn rootworm is not a significant pest: 
 
i. The common refuge may be planted as an in-field or adjacent refuge or as a separate block. Corn 
hybrids that do not contain PIP technologies for the control of corn borers or corn rootworms must 
be used for the refuge. 
 
ii. Separate block refuges must be planted within ½ mile of the MON 89034 x TC1507 x MON 87411 
x DAS-59122-7 field. 
 
iii. If perimeter or in-field strips are implemented as refuge, the strips must be at least four (4) rows 
wide. 
 
 The common refuge can be protected from lepidopteran damage by use of non-PIP insecticides if the 
population of one or more target lepidopteran pests of MON 89034 x TC1507 x MON 87411 x DAS-
59122-7 if economic thresholds are exceeded in the refuge. Economic thresholds will be determined 
using methods recommended by local or regional professionals (e.g., Extension Service agents, crop 
consultants). 
 
 The common 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 be applied in the same timeframe to MON 89034 x TC1507 x MON 87411 x 
DAS-59122-7. 
 
Region Refuge Size In-field or 
adjacent refuge is 
allowed 
Refuge separated 
by up to ½ 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-
PIP 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-
PIP 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-PIP 
corn 
Yes Yes

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EPA Reg. No. 524-632 
OPP ACC No. 00308646 and 00308662 
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, Shelb
y, and Tipton) 
5% non-PIP 
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-PIP 
corn 
Yes No 
 
c. Grower Agreements for MON 89034 x TC1507 x MON 87411 x DAS-59122-7 
 
1. Persons purchasing MON 89034 x TC1507 x MON 87411 x DAS-59122-7 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 TC1507 x MON 87411 x DAS-59122-7 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 TC1507 x MON 87411 x 
DAS-59122-7 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 TC1507 x MON 87411 x DAS-59122-7 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 
TC1507 x MON 87411 x DAS-59122-7 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

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EPA Reg. No. 524-632 
OPP ACC No. 00308646 and 00308662 
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 TC1507 x MON 
87411 x DAS-59122-7 
 
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 TC1507 x MON 87411 x DAS-
59122-7 corn users the importance of complying with the IRM program, as well as product 
performance expectations and guidance to growers on actions to take when unexpected damage occurs. 
The program shall include information encouraging MON 89034 x TC1507 x MON 87411 x DAS-
59122-7 corn users to pursue optional elements of the IRM program relating to refuge configuration 
and proximity to MON 89034 x TC1507 x MON 87411 x DAS-59122-7 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 TC1507 x MON 87411 x DAS-59122-7 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 TC1507 x MON 87411 x DAS-59122-
7 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. 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 the

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EPA Reg. No. 524-632 
OPP ACC No. 00308646 and 00308662 
next year to Bayer’s Bt corn products. 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 TC1507 x MON 87411 x 
DAS-59122-7 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 TC1507 x MON 
87411 x DAS-59122-7 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. 
 
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.

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EPA Reg. No. 524-632 
OPP ACC No. 00308646 and 00308662 
 
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 TC1507 x MON 87411 x DAS-59122-7 
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 
TC1507 x MON 87411 x DAS-59122-7 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 TC1507 x MON 87411 x DAS-59122-7 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 TC1507 x MON 87411 x DAS-59122-7 compliance assurance program activities and results 
for the prior year and plans for the MON 89034 x TC1507 x MON 87411 x DAS-59122-7 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 TC1507 x MON 87411 
x DAS-59122-7 seed sold and delivered. The refuge size requirement must be included on all 
PIP corn seed bags or bag tags. 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:

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EPA Reg. No. 524-632 
OPP ACC No. 00308646 and 00308662 
 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 TC1507 x MON 87411 x 
DAS-59122-7 is used. 
 
19. Bayer will use its available MON 89034 x TC1507 x MON 87411 x DAS-59122-7 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 TC1507 x MON 87411 x DAS-59122-7 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 TC1507 x MON 
87411 x DAS-59122-7 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; 
 
 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 Mitigation Plan for MON 89034 x TC1507 x MON 87411 x DAS-
59122-7 
 
1. EPA is imposing the following conditions for the Cry1A.105, Cry2Ab2, and Cry1F toxins 
expressed in MON 89034 x TC1507 x MON 87411 x DAS-59122-7 
 
Bayer will monitor for resistance to Cry1A.105, Cry2Ab2, and Cry1F expressed in MON 89034 x 
TC1507 x MON 87411 x DAS-59122-7 corn. The monitoring program shall consist of two 
approaches: (1) focused population sampling and laboratory testing; and (2) investigation of reports

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EPA Reg. No. 524-632 
OPP ACC No. 00308646 and 00308662 
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 TC1507 x MON 87411 x DAS-59122-7 corn and/or 
changes in resistance allele frequency in response to the use of MON 89034 x TC1507 x MON 87411 
x DAS-59122-7 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 TC1507 x MON 87411 x 
DAS-59122-7 corn. EPA shall be consulted prior to the implementation of such modifications. 
 
Bayer will report to EPA, on or before January 31
st 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 Cry1F 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 January 31st. 
The investigative steps will include the following: 
 
i. Re-test progeny of the collected 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

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EPA Reg. No. 524-632 
OPP ACC No. 00308646 and 00308662 
MON 89034 x TC1507 x MON 87411 x DAS-59122-7 corn 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 frequency in the original population; 
 
c. Determining whether the resistance allele 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 PIP 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.

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EPA Reg. No. 524-632 
OPP ACC No. 00308646 and 00308662 
 
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 TC1507 x MON 87411 x DAS-59122-7 corn 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 TC1507 x MON 87411 x DAS-59122-7 
corn fields in the affected region to control the target pest during the immediate growing 
season. 
 
 Destroy MON 89034 x TC1507 x MON 87411 x DAS-59122-7 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. 
 
 In standardized laboratory bioassays, the LC
50 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

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EPA Reg. No. 524-632 
OPP ACC No. 00308646 and 00308662 
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 January 31
st of each year, for the duration of the registration. 
 
2. EPA is imposing the following conditions for the Cry34/35Ab1, DvSnf7 dsRNA, and Cry3Bb1 
toxins expressed in MON 89034 x TC1507 x MON 87411 x DAS-59122-7 corn: 
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 TC1507 x MON 87411 x DAS-59122-7 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 TC1507 x MON 87411 x DAS-
59122-7 corn plants (take leaf samples to determine the presence of the CRW-active Bt 
protein); and

Page 15 of 21 
EPA Reg. No. 524-632 
OPP ACC No. 00308646 and 00308662 
 
b. Corn rootworm feeding caused root damage 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 inquiries). For MON 89034 x TC1507 x MON 87411 x DAS-
59122-7 corn fields meeting the criteria in part 1) above, Bayer must take the following actions: 
 
a. Collect at least 250 (ideally 500 or more) 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. 
 
o 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 containing the CRW traits in MON 89034 x TC1507 x MON 
87411 x DAS-59122-7 in fields with unexpected damage in previous years should be 
discouraged. Recommended management options include, but are not limited to, the 
following: 
 
o Primary option: 
 
• Rotation to non-host crop (e.g., soybean) 
 
o Secondary options: 
 
• Use of pyramided Bt corn products one or more different CRW PIP trait(s) 
 
• Use of different CRW PIP traits (i.e., an alternative CRW-active PIP) 
 
• Use of non-PIP or non-CRW protected corn 
 
o Tertiary options: 
 
• 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) 
 
• Additional corn rootworm control tools (e.g., soil applied insecticides,

Page 16 of 21 
EPA Reg. No. 524-632 
OPP ACC No. 00308646 and 00308662 
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 detailing 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: 
 
o The number of UXD reports investigated; 
 
o Location (by county and state); 
 
o CRW sampling (number and location of populations collected). 
 
b. Information from the previous season: 
 
o 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; 
 
o 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 addresses 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 TC1507 x MON 87411 x DAS-59122-7. 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 inquiry investigation results in a finding of Unexpected Damage; 
and 
 
b. Where green tissues are available and if plants are unusually stressed due to agronomic 
and/or environmental factors, Bt protein levels in affected plants are found to be within the

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EPA Reg. No. 524-632 
OPP ACC No. 00308646 and 00308662 
documented range for that hybrid (if data are available); and 
 
c. 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-PIP 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-PIP) 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-PIP 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. 
 
 
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.

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EPA Reg. No. 524-632 
OPP ACC No. 00308646 and 00308662 
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 TC1507 x MON 
87411 x DAS-59122-7, 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 the 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 in MON 89034 
x TC1507 x MON 87411 x DAS-59122-7 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 defined 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 results 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, Bayer 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;

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EPA Reg. No. 524-632 
OPP ACC No. 00308646 and 00308662 
ii. Discontinue sales/planting 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 definition for one of the CRW traits in the 
MON 89034 x TC1507 x MON 87411 x DAS-59122-7 is not met, continued use 
of the product with a 20% refuge; 
 
c. Use of different CRW PIP traits (i.e., an alternative CRW-active PIP); 
 
d. Use of non-PIP corn or non-CRW protected corn (with/without soil-applied 
insecticide); 
 
3. Tertiary options: 
 
a. If additional pest management need 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 control 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

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EPA Reg. No. 524-632 
OPP ACC No. 00308646 and 00308662 
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 part d above can be lifted, and growers can resume the use of MON 
89034 x TC1507 x MON 87411 x DAS-59122-7 corn 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. Annual Reporting Requirements for MON 89034 x TC1507 x MON 87411 x DAS-59122-7 
 
The following annual reports must be submitted: 
 
1. Compliance Assurance Plan: Compliance Assurance Program activities, including IRM Grower Survey 
results 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 (Cry1A.105, Cry2Ab2, and Cry1F only): results of monitoring and 
investigations of damage reports, January 31st of each year. 
 
3. IPM Stewardship Program (Cry34/35Ab1, DvSnf7 dsRNA, and Cry3Bb1 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 (Cry34/35Ab1, DvSnf7 dsRNA, and Cry3Bb1only): 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

Page 21 of 21 
EPA Reg. No. 524-632 
OPP ACC No. 00308646 and 00308662 
statements or claims substantially differing from the EPA-approved registration, the website will be referred to 
the EPA’s Office of Enforcement and Compliance Assurance. 
 
Your release for shipment of this product constitutes acceptance of these terms and 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 2/26/2016 
 
If you have any questions, please contact Matt Weiner by phone at (202) 564-1509 or via email at 
weiner.matthew@epa.gov. 
 
 S i n c e r e l y , 
 
 
 
 Alan Reynolds, Team Leader 
 Emerging Technologies Branch 
Biopesticides and Pollution 
 Prevention Division (7511M) 
Office of Pesticide Programs 
 
 
Enclosure

Plant-Incorporated Protectant Label
MON 89034 × TC1507 × MON 87411 × DAS-59122-7 
Insect-Protected, Herbicide-Tolerant Corn 
(OECD Unique Identifier: MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7) 
Active Ingredients:
dsRNA transcript comprising a DvSnf7 inverted repeat sequence derived from Diabrotica 
virgifera virgifera, and the genetic material (vector PV-ZMIR10871) necessary for its production 
in MON 89034 × TC1507 × MON 87411 × DAS-59122-7 (OECD Unique Identifier 
MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7) ...............≤ 0.00000044%*
Bacillus thuringiensis Cry1A.105 protein and the genetic material (vector PV-ZMIR245) 
necessary for its production in MON 89034 × TC1507 × MON 87411 × DAS-59122-7 (OECD 
Unique Identifier MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7)..............
......................................................................................................................................≤ 0.0088%*
Bacillus thuringiensis Cry2Ab2 protein and the genetic material (vector PV-ZMIR245) 
necessary for its production in MON 89034 × TC1507 × MON 87411 × DAS-59122-7 (OECD 
Unique Identifier MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7) .............
......................................................................................................................................≤ 0.0048%*
Bacillus thuringiensis Cry1F protein and the genetic material (vector PHP8999) necessary for its 
production in MON 89034 × TC1507 × MON 87411 × DAS-59122-7 (OECD Unique Identifier 
MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7) .....................≤ 0.00096%*
Bacillus thuringiensis Cry3Bb1 protein and the genetic material (vector PV-ZMIR10871) 
necessary for its production in MON 89034 × TC1507 × MON 87411 × DAS-59122-7 (OECD 
Unique Identifier MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7)
.................
…………………………………………………………………………………………………………... ≤ 0.0041%*
Bacillus thuringiensis Cry34Ab1 protein and the genetic material (vector PHP17662) necessary 
for its production in MON 89034 × TC1507 × MON 87411 × DAS-59122-7 (OECD Unique 
Identifier MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7).. ….....≤ 0.012%*
Bacillus thuringiensis Cry35Ab1 protein and the genetic material (vector PHP17662) necessary 
for its production in MON 89034 × TC1507 × MON 87411 × DAS-59122-7 (OECD Unique 
Identifier MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7)
..…...≤ 0.0026%*
Other Ingredients: 
06/14/2022
524-632

The marker protein CP4 EPSPS and the genetic material (vector PV-ZMIR10871) necessary for 
its production in MON 89034 × TC1507 × MON 87411 × DAS-59122-7 (OECD Unique 
Identifier: MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS 59122 7) ......... ≤ 0.036%* 
 
The marker protein PAT and the genetic material (vector PHP17662) necessary for its 
production in MON 89034 × TC1507 × MON 87411 × DAS-59122-7 (OECD Unique Identifier: 
MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7) ...................... ≤ 0.0001%* 
 
*Percentage (wt/wt) on a dry weight basis for forage tissue of MON 89034 × TC1507 × 
MON 87411 × DAS-59122-7 plants 
 
 
KEEP OUT OF REACH OF CHILDREN 
 
CAUTION 
 
NET CONTENTS_______ 
 
EPA Registration No. 524-632 
 
EPA Establishment No. 524-MO-002 
 
Bayer CropScience LP 
800 North Lindbergh Blvd. 
St. Louis, MO 63167

DIRECTIONS FOR USE 
 
It is a violation of Federal law to use this product in any manner inconsistent with its labeling. 
Information regarding commercial production as spec ified in the terms and conditions of this 
registration must be included in the Technology Use Guide. 
 
MON 89034 × TC1507 × MON 87411 × DAS-59122-7 protec ts corn crops from leaf, stalk, and 
ear damage caused by corn borers and from root damage caused by corn rootworm larvae. 
 
In order to minimize the risk of these pe sts developing resistance to MON 89034 × TC1507 × 
MON 87411 × DAS-59122-7 corn, an insect resistan ce management plan must be implemented 
which includes planting of a structured refuge. Growers who fail to comply with the IRM 
requirements risk losing access to Bayer’s corn PIP products. 
 
These refuge requirements do not apply to pl anting of inbred/hybrid corn seed productions, 
breeding, and small scale research trials on up to a total of 20,000 acres per county and up to a 
combined United States (U.S.) total of 250,000 acres per plant-incorporated protectant (PIP) 
active ingredient per registrant per year. 
 
Several options for deployment of the refuge for MON 89034 × TC1507 × MON 87411 × DAS-
59122-7 are available to growers. These options are based on the planting of MON 89034 × 
TC1507 × MON 87411 × DAS-59122-7 in cotton or non-c otton growing regions and the insect 
pressure present in those locations. The refuge size s for these regions are either 5% (i.e. 5 acres 
of non- B.t. corn for every 95 acres MON 89034 × TC1507 × MON 87411 × DAS-59122-7 
planted) or 20% (20 acres of non- B.t. corn for every 80 acres of MON 89034 × TC1507 × 
MON 87411 × DAS-59122-7 planted) and are presented in the table below: 
 
Region Refuge 
Size 
In-field or adjacent 
refuge is allowed 
Refuge separated by 
up to ½ 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

Region Refuge 
Size 
In-field or adjacent 
refuge is allowed 
Refuge separated by 
up to ½ mile is 
allowed 
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 
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 
 
 
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 B.t. technologies for the control of 
corn borers or corn rootworms. It can be plante d as a block within or adjacent (e.g., across the 
road) to the MON 89034 × TC1507 × MON 87411 × DA S-59122-7, perimeter strips (i.e., strips 
around the field), or in-field strips. If perimete r or in-field strips are implemented, the strips 
must be at least four (4) consecutive rows wide . The refuge can be protected from lepidopteran 
damage by use of non- B.t. insecticides if the population of one or more target lepidopteran pests 
of MON 89034 × TC1507 × MON 87411 × DAS-59122-7 in the refuge exceeds economic 
threshold. In addition, the refuge can be protec ted from CRW damage by an appropriate seed 
treatment or soil insecticide; however, insectic ides labeled for adult CRW control should be 
avoided in the refuge during th e 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).

If corn rootworms are not significant within a re gion, 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 × 
TC1507 × MON 87411 × DAS-59122-7 field. The structured refuge must be planted with corn 
hybrids that do not contain B.t. 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). 
 
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 
Lesser corn stalk borer Elasmopalpus lignosellus 
Sugarcane borer (SCB) Diatraea saccharalis 
Black cutworm Agrotis ipsilon 
 
Western corn rootworm (WCRW) Diabrotica virgifera virgifera 
Northern corn rootworm (NCRW) Diabrotica barberi 
Mexican corn rootworm (MCRW) Diabrotica virgifera zeae 
 
 
__________________________ 
 
MON 89034 × TC1507 × MON 87411 × DAS-59122-7 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