crop-chem-docs/corpus/epa_ppls/524-575.md

# MON 89034

- EPA Reg No: **524-575**
- 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 (0.0056%); Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary (vector PV-ZMIR245) for its production in corn (0.0055%)
- Label accepted: 2022-09-26
- Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00575-20220926.pdf

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 
Washington, D.C. 20460 
OFFICE OF CHEMICAL SAFETY 
AND POLLUTION PREVENTION
September 26, 2022 
Edwards Allen, Ph.D. 
Global Regulatory Manager 
Bayer U.S. – Crop Science 
700 Chesterfield Parkway West 
Chesterfield, Missouri 63017 
Subject: Non-PRIA Amendment - Ex tension of the registration expiration date and label revisions to 
change the company name from Monsanto to Bayer and include minor revisions to the insect 
resistance management directions for use 
Product Name: MON 89034 
EPA Registration Number: 524-575 
Submission Date: January 28, 2022 
OPP Case Number: 00338517 
Dear Dr. Allen: 
The amendment referenced above, submitted in connection with registration under Section 3(c)(5) of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 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 September 30, 2023.
2. The subject registration will be limited to Bacillus thuringiensis Cry1A.105 protein and the genetic
material necessary for its production (vector PV-ZMIR245) in corn event MON 89034 (OECD Unique
Identifier: MON-8934-3), and Bacillus thuringiensis Cry2Ab2 protein and the genetic material
necessary for its production (vector PV-ZMIR245) in corn event MON 89034 (OECD Unique Identifier:
MON-8934-3), for use in field or sweet corn.
3. Submit and/or cite all data required for registration or registration review of MON 89034 when the EPA
requires all registrants of similar products to submit such data.
4. This plant-incorporated protectant (PIP) may be combined through conventional breeding with other
registered plant-incorporated protectants that are similarly approved for use in combination, through
conventional breeding, with other registered plant-incorporated protectants to produce inbred corn lines
and hybrid corn varieties with combined pesticidal traits.
5. Bayer CropScience LP (Bayer) must commit to do the following Insect Resistance Management (IRM)
Program, consisting of the following elements:
 Requirements (except for sweet corn use) relating to creation of a lepidopteran refuge
(consisting of corn that does not contain any Bt trait for lepidopteran control) in conjunction
with the planting of any acreage of MON 89034 corn;

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 Requirements for Bayer to prepare and require MON 89034 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 and Cry2Ab2 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 or Cry2Ab2 was detected, as well as to report on activity under the plan to EPA. 
 
 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 corn. Seed bags and/or bag tags for corn hybrids that 
contain plant-incorporated protectants produced in MON 89034 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 August 31st of each year, to submit reports on Cry1A.105 
and Cry2Ab2 resistance monitoring. 
 
a. Refuge Requirements for MON 89034 Field Corn 
 
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 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 
(PIP) active ingredient per registrant per year. Furthermore, these refuge requirements do not apply to 
MON 89034 commercial hybrid sweet corn. 
 
1. 
Corn Belt Refuge Requirements for Bt Corn. For MON 89034 field corn grown outside cotton-
growing areas (e.g., the Corn Belt), grower agreements (also known as stewardship agreements) will 
specify that growers must adhere to the refuge requirements as described in the growers 
guide/product use guide and/or in supplements to the growers guide/product use guide. 
 
i. Specifically, growers must plant a structured refuge of at least 5% non-Bt corn and/or non-
lepidopteran resistant Bt corn that may be treated with insecticides as detailed below, to control

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lepidopteran stalk-boring and other pests. 
 
ii. The refuge and MON 89034 corn should be sown on the same day, or with the shortest window 
possible between planting dates to ensure development is similar among varieties. 
 
iii. Refuge planting options include: separate fields, blocks within fields (e.g., along the edges or 
headlands), and strips across the field. 
 
iv. External refuges must be planted within ½ mile of the Bt fields. 
 
v. When planting the refuge as strips across the field or as perimeter strips, refuges must be at least 
4 consecutive rows wide. 
 
vi. The refuge can be protected from lepidopteran damage by use of non-Bt insecticides if the 
population of one or more target lepidopteran pests of MON 89034 in the refuge exceeds 
economic thresholds. Economic thresholds will be determined using methods recommended by 
local or regional professionals (e.g., Extension Service agents or crop consultants). Instructions 
to growers will specify that microbial Bt insecticides must not be applied to non-Bt corn and/or 
non-lepidopteran resistant Bt corn refuges. 
 
2. Cotton-Growing Area Refuge Requirements for Bt Corn. For Bt field corn grown in cotton-growing 
areas, grower agreements (also known as stewardship agreements) will specify that growers must 
adhere to the refuge requirements as described in the growers guide/product use guide and/or in 
supplements to the growers guide/product use guide. 
 
i. Specifically, growers in these areas must plant a structured refuge of at least 20% non-Bt corn 
and/or non-lepidopteran resistant Bt corn that may be treated with insecticides as needed to 
control lepidopteran stalk-boring and other pests. 
 
ii. The refuge and MON 89034 corn should be sown on the same day, or with the shortest window 
possible between planting dates to ensure development is similar among varieties. 
 
iii. Refuge planting options include: separate fields, blocks within fields (e.g., along the edges or 
headlands), and strips across the field. 
 
iv. External refuges must be planted within ½ mile of the Bt fields. 
 
v. When planting the refuge as strips across the field or as perimeter strips, refuges must be at least 
(4) consecutive rows wide. 
 
vi. The refuge can be protected from lepidopteran damage by use of non-Bt insecticides if the 
population of one or more target lepidopteran pests of MON 89034 in the refuge exceeds 
economic thresholds. Economic thresholds will be determined using methods recommended by 
local or regional professionals (e.g., Extension Service agents or crop consultants). Instructions 
to growers will specify that microbial Bt insecticides must not be applied to non-Bt corn and/or 
non-lepidopteran resistant Bt corn refuges. 
 
vii. Cotton-growing areas include the following states: Alabama, Arkansas, Florida, Georgia, 
Louisiana, North Carolina, Mississippi, South Carolina, Oklahoma (only the counties of

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Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, and 
Washita), Tennessee (only the counties of Carroll, Chester, Crockett, Dyer, Fayette, Franklin, 
Gibson, Hardeman, Hardin, Haywood, Lake, Lauderdale, Lincoln, Madison, Obion, Rutherford, 
Shelby, and Tipton), Texas (except the counties of Carson, Dallam, Hansford, Hartley, 
Hutchinson, Lipscomb, Moore, Ochiltree, Roberts, and Sherman), Virginia (only the counties of 
Dinwiddie, Franklin City, Greensville, Isle of Wight, Northampton, Southampton, Suffolk City, 
Surrey, and Sussex), and Missouri (only the counties of Dunklin, New Madrid, Pemiscot, Scott, 
and Stoddard). 
 
b. Post-Harvest Requirements for MON 89034 Sweet Corn 
 
Sweet corn is harvested long before field corn. Therefore, if the sweet corn stalks remaining in the field 
and any insects remaining in the stalks are destroyed shortly after harvest, a refuge is not needed as part 
of the IRM program for sweet corn. Growers must adhere to the following types of crop destruction 
requirements as described in the grower guide/product use guide and/or in supplements to the grower 
guide/product use guide. 
 
1. Crop destruction must occur no later than 30 days following harvest, but preferably within 14 days. 
 
2. The allowed crop destruction methods are rotary mowing, discing, or plow-down. Crop destruction 
methods should destroy any surviving resistant insects. 
 
c. Grower Agreements for MON 89034 Corn 
 
1. Persons purchasing MON 89034 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 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 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 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 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

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submit reports within three months of the Agency’s request. 
 
7. Bayer must allow a review of the grower agreements and grower agreement records by EPA or by a 
State pesticide regulatory agency if the State agency can demonstrate that confidential business 
information, including names, personal information, and grower license numbers of the growers, 
will be protected. 
 
d. IRM Education and IRM Compliance Monitoring Program for MON 89034 Corn 
 
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 corn users the importance of 
complying with the IRM program. The program shall include information encouraging MON 
89034 corn users to pursue optional elements of the IRM program relating to refuge configuration 
and proximity to MON 89034 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 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 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

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non-compliance with refuge requirements for MON 89034 within a five-year period will be denied 
access the following year to Bayer’s Bt corn products for which the grower is required to plant a 
separate structured refuge. Similarly, seed dealers who are not fulfilling their obligations to 
inform/educate growers of their IRM obligations will lose their opportunity to sell Bt corn. 
 
6. The IRM compliance assurance program shall include an annual survey, conducted by an 
independent third party, of a statistically representative sample of growers MON 89034 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 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.

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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 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 
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 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 compliance assurance program activities and results for the prior year and plans for the 
MON 89034 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 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

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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 is used. 
 
19. Bayer will use its available MON 89034 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 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 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 the 
following year to Bayer’s Bt corn products for which the grower is required to plant a 
separate structured refuge. Similarly, seed dealers who are not fulfilling their obligations 
to inform/educate growers of their IRM obligations will lose their opportunity to sell Bt 
corn. 
 
e. Insect Resistance Monitoring and Mitigation Plan for MON 89034 Corn 
 
EPA is imposing the following conditions for the Cry1A.105 and Cry2Ab2 toxins expressed in 
MON 89034

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Bayer will monitor for resistance to Cry1A.105 and Cry2Ab2 expressed in MON 89034 corn. 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 corn and/or changes in resistance allele frequency in 
response to the use of MON 89034 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 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. 
 
Any incidence of unusually low sensitivity to the Cry1A.105 or Cry2Ab2 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:

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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 
MON 89034 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 Bt corn; 
 
 The seed used had the proper percentage of corn expressing Bt protein; 
 
 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

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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 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 corn fields in the affected region to control 
the target pest during the immediate growing season. 
 
 Destroy MON 89034 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;

Page 12 of 13 
EPA Reg. No. 524-575 
OPP Case No. 00338517  
 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. 
 
f. Annual Reporting Requirements for MON 89034 corn 
 
The following annual reports must be submitted: 
 
1. Compliance Assurance Plan: Compliance Assurance Program activities, including IRM Grower 
Survey (only for years in which the survey was conducted) 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 and Cry2Ab2 only): Results of monitoring and 
investigations of damage reports, August 31st of each year.

Page 13 of 13 
EPA Reg. No. 524-575 
OPP Case No. 00338517  
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. 
 
If you have any questions, please contact Matt Weiner of my team via email at weiner.matthew@epa.gov or 
by phone at (202) 566-1509. 
 
 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: Stamped Label

Plant-Incorporated Protectant Label 
MON 89034 
Lepidopteran-Protected Corn 
(OECD Unique Identifier : MON-89Ø34-3) 
Active Ingredients: 
Bacillus thuringiensis Cry1A.105 protein and the genetic material (Vector PV-ZMIR245) 
necessary for its production in MON 89034 (OECD Unique Identifier: MON-89Ø34-3) ... 
” 
Bacillus thuringiensis Cry2Ab2 protein and the genetic material (Vector PV-ZMIR245) 
necessary for its production in MON 89034 (OECD Unique Identifier: MON-89Ø34-3) ... 
” 
*Percentage (wt/wt) on a dry weight basis for whole plant (forage) 
KEEP OUT OF REACH OF CHILDREN 
CAUTION 
NET CONTENTS__________ 
EPA Registration No. 524-575 
EPA Establishment No. 524-MO-002 
Bayer Crop Science LP 
800 North Lindbergh Blvd. 
St. Louis, MO 63167 
09/26/2022
524-575

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 specified in the terms and 
conditions of this registration must be included in the Technology Use. 
MON 89034 can be used to protect corn plants from leaf, stalk, and ear damage caused by 
corn borers. In order to minimize the risk of corn borers developing resistance to 
MON 89034 field corn, an insect resistance management (IRM) 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 plant-incorporated protectant (PIP) 
products
.
This 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. 
1) Refuge Requirements for MON 89034 Field Corn 
In order to minimize the risk of corn borers developing resistance to MON 89034 field 
corn, an IRM plan must be implemented which includes planting of a structured refuge. 
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 PIP active ingredient per registrant per year. Furthermore, 
these refuge requirements do not apply to MON 89034 commercial hybrid sweet corn. 
a) Corn-Belt/Non-Cotton Growing Area Refuge Requirements 
For MON 89034 field corn grown outside cotton-growing areas (e.g., the Corn Belt), 
grower guides must specify that growers must adhere to the following refuge requirements. 
Growers must plant a structured refuge of at least 5% corn, which is not a lepidopteran-
protected B.t. corn hybrid. The refuge may be treated with insecticides, as detailed below, 
to control lepidopteran stalk-boring and other pests. 
The 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 in the refuge exceeds 
economic threshold. Economic thresholds will be determined using methods recommended 
by local or regional professionals (e.g., Extension Service agents or crop consultants). 
Instructions to growers will specify that microbial B.t. insecticides must not be applied to 
non-B.t. corn refuges.

Refuge planting options include : separate fields, blocks within fields (e.g., along the edges 
or headlands), and strips across the field. 
External refuges must be planted within ½ mile. A schematic of one refuge option with the 
refuge planted within a ½ mile of the MON 89034 field is shown below: 
When planting the refuge in strips across the field, refuges must be at least 4 consecutive 
rows wide. 
b) Cotton-Growing Area Refuge Requirements 
Cotton-growing areas include the following states: Alabama, Arkansas, Georgia, Florida, 
Louisiana, North Carolina, Mississippi, South Carolina, Oklahoma (only the counties of 
Beckham, Caddo, Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, 
Washita), Tennessee (only the counties of Carroll, Chester, Crockett, Dyer, Fayette, 
Franklin, Gibson, Hardeman, Hardin, Haywood, Lake, Lauderdale, Lincoln, Madison, 
Obion, Rutherford, Shelby, and Tipton), Texas (except the counties of Carson, Dallam, 
Hansford, Hartley, Hutchinson, Lipscomb, Moore, Ochiltree, Roberts, and Sherman), 
Virginia (only the counties of Dinwiddie, Franklin City, Greensville, Isle of Wight, 
Northampton, Southampton, Suffolk City, Surrey, Sussex), and Missouri (only the counties 
of Dunklin, New Madrid, Pemiscot, Scott, Stoddard). 
For MON 89034 field corn grown in cotton-growing areas, grower guides must specify 
that growers must adhere to the following refuge requirements. 
Growers must plant a structured refuge of at least 20% corn which is not a lepidopteran-
protected B.t. corn hybrid. The refuge may be treated with insecticides, as detailed below, 
to control lepidopteran stalk-boring and other pests. 
MON 89034 Refuge 
Non-Bt lepidopteran 
protected corn 
MON 89034
ч ½ mile
Refuge 
Non-Bt lepidopteran 
protected corn

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 in the refuge exceeds 
economic threshold. Economic thresholds will be determined using methods recommended 
by local or regional professionals (e.g., Extension Service agents, crop consultants). 
Instructions to growers will specify that microbial B.t. insecticides must not be applied to 
non-B.t. corn refuges. 
Refuge planting options include: separate fields, blocks within fields (e.g., along the edges 
or headlands), and strips across the field. 
External refuges must be planted within ½ mile. A schematic of one refuge option with the 
refuge planted within a ½ mile of the MON 89034 field is shown below: 
When planting the refuge in strips across the field, refuges must be at least four (4) 
consecutive rows wide. 
2) Post-Harvest Requirements for MON 89034 Sweet Corn 
For MON 89034 sweet corn, growers are required to destroy any MON 89034 sweet corn 
stalks that remain in the field following harvest via rotary mowing, discing, or plow-down 
within one (1) month of harvest. 
MON 89034
ч ½ mile
Refuge 
Non-Bt lepidopteran 
protected corn 
MON 89034 Refuge 
Non-Bt lepidopteran 
protected corn

Corn Insects Controlled or Suppressed 
European corn borer Ostrinia nubilalis
Southwestern corn borer Diatraea grandiosella
Southern cornstalk borer Diatraea crambidoides
Corn earworm Helicoverpa zea
Fall armyworm Spodoptera frugiperda
Stalk borer Papaipema nebris 
Lesser corn stalk borer Elasmopalpus lignosellus 
Sugarcane borer Diatraea saccharalis
Sales of corn hybrids that contain Bayer’s B.t. corn plant-incorporated protectant must be 
accompanied by a Grower Guide which includes information on planting, production, and insect 
resistance management and notes that routine applications of insecticides to control these insects 
are usually unnecessary when corn containing the B.t. proteins is planted. 
MON 89034 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