crop-chem-docs/corpus/epa_ppls/524-612.md

# MON 89034 X TC1507 SEED BLEND

- EPA Reg No: **524-612**
- 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 (0.0012%); Bacillus thuringiensis Cry1A.105 protein and genetic material necessary (vector PV-ZMIR245) for its production in corn (0.0026%); Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary (vector PV-ZMIR245) for its production in corn (0.0053%)
- Label accepted: 2018-11-07
- Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00612-20181107.pdf

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 
 Washington, D.C. 20460 
OFFICE OF CHEMICAL SAFETY 
AND POLLUTION PREVENTION 
 
 
 
November 7, 2018 
 
 
David J. Chi 
Regulatory Affairs Manager 
Monsanto Company 
 800 North Lindbergh Blvd. 
St. Louis, MO 63137 
 
Subject: Amendment to update the label, compliance terms, and extend the expiration date of MON 
89034 x TC1507 Seed Blend 
 EPA Registration Number: 524-612 
 Submission Date: 5/23/2018 
 OPP Decision Number: 542180 
 
Dear Mr. Chi: 
 
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 November 30, 2030. 
 
2. The subject registration will be limited to a field corn seed blend of up to 95% Bacillus thuringiensis 
Cry1A.105 and Cry2Ab2 proteins and the genetic material (vector PV-ZMIR245) necessary for their 
production in corn event MON 89034 (OECD Unique Identifier: MON-89Ø34-3) and Bacillus 
thuringiensis Cry1F protein and the genetic material (vector PHP8999) necessary for its production in 
corn event TC1507 (OECD Unique Identifier: DAS-Ø15Ø7-1) field corn seed and a minimum of 5% 
non-Bt corn seed that when planted creates an interspersed refuge within the field. 
 
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. Monsanto Company (hereafter referred to as Monsanto) must commit to do the following Insect 
Resistance Management (IRM) Program, consisting of the following elements: 
 
 Requirements relating to a refuge assurance program for ensuring the correct refuge blend 
percentage.

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 Requirements relating to creation of a lepidopteran refuge (consisting of corn that does not 
contain any Bt trait for lepidopteran control) in cotton growing regions in conjunction with the 
planting of any acreage of MON 89034 x TC1507 Seed Blend corn; 
 
 Requirements for Monsanto to prepare and require MON 89034 x TC1507 Seed Blend corn users 
to sign grower agreements that impose binding contractual oblig ations on growers to comply 
with the refuge requirements. 
 
 Requirements for Monsanto to develop, implement, and report to EPA on programs to 
educate growers about IRM requirements. 
 
 Requirements for Monsanto to develop, implement, and report to EPA on programs to 
evaluate and promote growers’ compliance with IRM requirements. 
 
 Requirements for Monsanto 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, Cry1F, or Cry2Ab2 proteins in the target insects. 
 
 Requirements for Monsanto to develop, and if triggered, to implement a remedial action plan 
that would contain measures Monsanto would take in the event that any field-relevant insect 
resistance to Cry1A.105, Cry1F, or Cry2Ab2 was detected, as well as to report on activity 
under the plan to EPA. 
 
 Requirements for Monsanto 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. Monsanto is required to submit reports within three months of the 
Agency’s request. 
 
 Bag Tag Requirements for MON 89034 x TC1507 Seed Blend corn. Seed bags and/or bag tags 
for corn hybrids that contain plant- incorporated protectants produced in MON 89034 x 
TC1507 Seed Blend corn must display the registration number and active ingredients, and 
stipulate that growers read the Monsanto 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. 
 
a. Refuge Requirements for MON 89034 x TC1507 Seed Blend Corn 
 
The following information must be included on the product bag o r bag-tag as sold per respective region and in 
the Grower Guide: 
 
Corn Belt/Non-Cotton Growing Areas 
 
MON 89034 x TC1507 Seed Blend contains a Lepidopteran refuge that is “in the bag” and is automatically 
implemented when the grower plants the product. No additional refuge is required when planting this product. 
 
Foliar insecticide treatments for control of European corn borer, corn earworm, southwestern corn borer, fall 
armyworm, black cutworm, western bean cutworm, lesser corn stalk borer, southern corn stalk borer, stalk borer 
and sugarcane borer may be applied only if economic thresholds are reached for one or more of these target

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pests. Foliar insecticide treatments are also permitted for control of corn rootworm adults if economic 
thresholds are reached. Economic thresholds will be determined using methods recommended by local or 
regional professionals (e.g., Extension Service agents, crop consultants). 
 
Cotton-Growing Region Refuge Requirements 
 
These refuge requirements do not apply to seed increase/propagation of inbred and hybrid seed corn up to a 
total of 20,000 acres per county and up to a combined United States (U.S.) total of 250,000 acres per plant-
incorporated protectant (PIP) active ingredient per registrant per year. Grower agreements (also known as 
stewardship agreements) will specify that growers must adhere to the refuge requirements as described in the 
grower guide/product use guide and/or in supplements to the grower guide/product use guide. 
 
In the cotton-growing area where corn earworm is a significant pest: 
 
 A 20% refuge must be planted with non-Bt corn hybrids. 
 
 MON 89034 x TC1507 Seed Blend and the 20% non-Bt refuge should be sown on the same day, or with 
the shortest window possible between planting dates. 
 
 External refuges may be planted as an in-field or adjacent (e.g., across the road) refuge or planted as a 
separate block within 1/2 mile of the MON 89034 x TC1507 Seed Blend field. 
 
 In field refuge options include blocks, perimeter strips (i.e., along the edges or headlands), or in-field 
strips. 
 
 When planting the refuge in strips across the field, refuges must be at least four (4) rows wide. 
 
 Foliar insecticide treatments for control of European corn borer, corn earworm, southwestern corn borer, 
fall armyworm, black cutworm, western bean cutworm, lesser corn stalk borer, southern corn stalk 
borer, stalk borer and sugarcane borer may be applied only if economic thresholds are reached for one or 
more of these target pests. Economic thresholds will be determined using methods recommended by 
local or regional professionals (e.g., Extension Service agents, crop consultants). Microbial Bt 
insecticides must not be applied to non-Bt corn refuge plants. 
 
 Cotton-growing areas include the following states: Alabama, Arkansas, Georgia, Florida, Louisiana, 
North Carolina, Mississippi, South Carolina, Oklahoma (only counties of Beckham, Caddo, Comanche, 
Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, and Washita), Tennessee (only the counties of 
Carroll, Chester, Crockett, Dyer, Fayette, Franklin, Gibson, Hardeman, Hardin, Haywood, Lake, 
Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby, and Tipton), Texas (except the counties of 
Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, Moore, Ochiltree, Roberts, and Sherman), 
Virginia (only the counties of Dinwiddie, Franklin City, Greensville, Isle of Wight, Northampton, 
Southampton, Suffolk City, Surrey, and Sussex) and Missouri (on
ly the counties of Dunklin, New 
Madrid, Pemiscot, Scott, and Stoddard). All other states and counties are considered to be in the corn-
growing area where no structured refuge is required. 
 
b. Grower Agreements for MON 89034 x TC1507 Seed Blend Corn 
 
1. Persons purchasing MON 89034 x TC1507 Seed Blend corn must sign a grower agreement. The term 
grower agreement refers to any grower purchase contract, license agreement, or similar legal document.

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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. Monsanto 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 Seed Blend corn will affirm annually that they are contractually bound to comply with the 
requirements of the IRM program. 
 
4. Monsanto must continue to use its current grower agreement for MON 89034 x TC1507 Seed Blend corn. 
If Monsanto 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, Monsanto 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. Monsanto shall maintain records of all MON 89034 x TC1507 Seed Blend corn grower agreements for a 
period of three (3) years from December 31st of the year in which the agreement was signed. 
 
6. Monsanto shall make available to the Agency upon request records of the number of units of MON 89034 
x TC1507 Seed Blend 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. Monsanto is required 
to submit reports within three months of the Agency’s request. 
 
7. Monsanto 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. 
 
c. IRM Education and IRM Compliance Monitoring Program for MON 89034 x TC1507 Seed 
Blend Corn in EPA-designated Cotton Counties 
 
1. Monsanto 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 Seed Blend corn users the 
importance of complying with the IRM program, as well as seed blend product performance expectations 
and guidance to growers on actions to take when unexpected damage occurs. The program shall include 
information encouraging MON 89034 x TC1507 Seed Blend corn users to pursue optional elements of the 
IRM program relating to refuge configuration and proximity to MON 89034 x TC1507 Seed Blend 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 Seed Blend corn user separate from 
the grower technical guide. The communication shall inform the user of the current IRM requirements and 
specifically the need to plant a lepidopteran refuge in cotton growing regions. Monsanto 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. Monsanto shall revise, and expand as necessary, its education program to take into account the information

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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, Monsanto 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). Monsanto 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. Monsanto must implement and improve an ongoing IRM compliance assurance program designed to 
evaluate the extent to which growers purchasing MON 89034 x TC1507 Seed Blend corn are compliant 
with the requirement of a 20% refuge for lepidopteran pests in cotton growing areas, and that takes such 
actions as are reasonably needed to assure that growers who have not complied with the program either do 
so in the future or lose their access to Monsanto’s Bt corn products. Monsanto 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. Monsanto 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, Monsanto must use a consistent set of standards for responding to 
non-compliance. An individual grower found to be significantly out of compliance two (2) years in a row 
would be denied access the next year to Monsanto’s Bt corn products for which the grower is required to 
plant a separate structured refuge. Similarly, seed dealers who are not fulfilling their obligations to 
inform/educate growers of their IRM obligations will lose their opportunity to sell Bt corn. 
 
6. The IRM compliance assurance program shall include an annual survey, conducted by an independent third 
party, of a statistically representative sample of growers MON 89034 x TC1507 Seed Blend corn. The 
survey shall be conducted in odd-numbered years beginning in 2019 and shall include growers who plant 
100 or more acres of corn in the Southern U.S. corn-cotton areas. Monsanto 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 Seed Blend 
corn if Monsanto 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. Monsanto 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 Monsanto is not a participant of an industry working group (e.g., the ABSTC) and 
Monsanto’s sales of integrated refuge products are equal to or greater than 70% of Monsanto’s total Bt corn

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sales in the prior year, then no anonymous grower survey is required in the U.S. Corn Belt. If Monsanto’s 
sales of integrated refuge products fall below 70% of Monsanto’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 Monsanto’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, Monsanto 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. Monsanto shall confer with other registrants and EPA 
on the design and content of the survey prior to its implementation. 
 
10. Monsanto 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. 
Monsanto must confer with EPA prior to adopting any changes. 
 
11. Monsanto shall conduct and enhance an annual on-farm assessment program. Monsanto shall train its 
representatives who make on-farm visits with MON 89034 x TC1507 Seed Blend 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, 
Monsanto shall take appropriate action, consistent with its phased compliance approach, to promote 
compliance. 
 
12. Monsanto shall implement a program for investigating legitimate tips and complaints that MON 89034 x 
TC1507 Seed Blend 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, Monsanto shall 
take appropriate action, consistent with its phased compliance approach. 
 
13. If a grower, who purchases MON 89034 x TC1507 Seed Blend corn for planting, was specifically 
identified as not being in compliance during the previous year, Monsanto 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, Monsanto must provide a report to EPA summarizing the MON 
89034 x TC1507 Seed Blend compliance assurance program activities and results for the prior year and 
plans for the MON 89034 x TC1507 Seed Blend compliance assurance program for the current year. 
Within one month of submitting this report to EPA, the registrant shall meet with EPA to discuss its 
findings. The report must inform EPA of the number of growers deemed ineligible to purchase Bt corn

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seed on the basis of continued non-compliance with the insect resistance management refuge requirements. 
Monsanto may elect to coordinate information with other registrants and report collectively the results of 
compliance assurance programs. 
 
15. Monsanto and the seed corn dealers for Monsanto 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. Monsanto 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. Monsanto 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 Seed Blend 
seed sold and delivered. The purpose of this bag tag is to remind growers that MON 89034 x 
TC1507 Seed Blend products require a separate 20% lepidopteran refuge in cotton growing 
areas. The PIP product label accepted by EPA must include how this information will be 
conveyed to growers via text and graphics. 
 
18. Monsanto will focus the majority of on-farm assessments on regions with the greatest risks for resistance: 
 
 Use Bt corn adoption, pest pressure information, and other available information to identify 
regions where the risk of resistance is greatest; 
 
 Focus approximately two-thirds of on-farm assessments on these regions, with the remaining 
assessments conducted across other regions where MON 89034 x TC1507 Seed Blend is used. 
 
19. Monsanto will use its available MON 89034 x TC1507 Seed Blend 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 Seed Blend corn product but may have purchased little or no 
refuge seed from the registrant, licensee, or affiliated company. 
 
20. Monsanto 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. Monsanto will annually refine the on-farm assessment program for the MON 89034 x TC1507 Seed Blend 
corn product to reflect the adoption rate and level of refuge compliance for the product.

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22. Monsanto 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 Monsanto, seed 
supplier, or third-party assessor, after completing the assessment process; 
 
 Monsanto 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 Monsanto’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. 
 
d. Insect Resistance Monitoring and Mitigation Plan for MON 89034 x TC1507 Seed Blend Corn 
 
1. EPA is imposing the following conditions for the Cry1A.105, Cry1F, and Cry2Ab2 toxins expressed 
in MON 89034 x TC1507 Seed Blend 
 
Monsanto will monitor for resistance to Cry1A.105, Cry1F, or Cry2Ab2 expressed in MON 89034 x TC1507 
Seed Blend 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 
 
Monsanto 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 Seed Blend corn and/or changes in resistance allele frequency in response to the use of 
MON 89034 x TC1507 Seed Blend 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

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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 Seed Blend corn. EPA shall be 
consulted prior to the implementation of such modifications. 
 
Monsanto 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, Cry1F, 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: 
 
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 x TC1507 Seed Blend 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 resistan
ce appears to be increasing or spreading, 
Monsanto 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 
 
Monsanto will follow up on grower, extension specialist, or consultant reports of unexpected levels of 
damage by the lepidopteran pests listed on the pesticide label. Monsanto will instruct its customers to contact 
them if such incidents occur. Monsanto will investigate all legitimate reports submitted to the company or the

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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), Monsanto 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 damage, 
that no climatic or cultural reasons could be responsible for the damage, and 
 
 That there could be no other reasonable causes for the damage. 
 
EPA does not interpret suspected resistance to mean grower reports of possible control failures or suspicious 
results from annual insect monitoring assays, nor does EPA intend that extensive field studies and testing be 
undertaken to confirm scientifically the presence of insects resistant to MON 89034 x TC1507 Seed Blend 
corn in commercial production fields before responsive measures are undertaken. 
 
If resistance is suspected, Monsanto will instruct growers to do the following: 
 
 Use alternative control measures in MON 89034 x TC1507 Seed Blend corn fields in the affected 
region to control the target pest during the immediate growing season. 
 
 Destroy MON 89034 x TC1507 Seed Blend 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, Monsanto 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).

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OPP Decision No. 542180   
 
 In standardized laboratory bioassays using diagnostic concentrations of the Bt protein suited to the 
target pest in question, the pest exhibits resistance that has a genetic basis and the level of survivorship 
indicates that there may be a resistance allele frequency of ≥ 0.1 in the sampled population. 
 
 In standardized laboratory bioassays, the LC50 exceeds the upper limit of the 95% confidence interval 
of the LC50 for susceptible populations surveyed both in the original baselines developed for this pest 
species and in previous years of field monitoring. 
 
Response to Confirmed Resistance in a Key Target Pest as the Cause of Unexpected Levels 
of Damage in the Field 
 
When field resistance is confirmed (as defined above), the following steps will be taken by Monsanto: 
 
 EPA will receive notification within 30 days of resistance confirmation; 
 
 Affected customers and extension agents will be notified about confirmed resistance within 30 days; 
 
 Monitoring will be increased in the affected area and local target pest populations will be 
sampled annually to determine the extent and impact of resistance; 
 
 If appropriate (depending on the resistant pest species, the extent of resistance, the timing of 
resistance, and the nature of resistance, and the availability of suitable alternative control measures), 
alternative control measures will be employed to reduce or control target pest populations in the 
affected area. Alternative control measures may include advising customers and extension agents in 
the affected area to incorporate crop residues into the soil following harvest to minimize the 
possibility of over-wintering insects, and/or applications of chemical insecticides; 
 
 Unless otherwise agreed with EPA, stop sale and distribution of the relevant lepidopteran-active Bt 
corn hybrids in the affected area immediately until an effective local mitigation plan, approved by 
EPA, has been implemented; 
 
 Monsanto will develop a case-specific resistance management action plan within 90 days according 
to the characteristics of the resistance event and local agronomic needs. Monsanto 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; 
 
 Monsanto 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.

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OPP Decision No. 542180   
 
 
e. Refuge Assurance Program for MON 89034 x TC1507 Seed Blend corn 
 
Monsanto must implement a Blended Seed Refuge Assurance Program designed to ensure MON 89034 x 
TC1507 Seed Blend corn products are formulated with the appropriate rate of refuge seeds. The program 
must include the following four elements: 
 
1. Trait purity check on seed lots prior to blending; 
 
2. Standard Operating Procedures for the blending process; 
 
3. Calibration of blending equipment; and 
 
4. Records and data retention records for seed blend products. 
 
 Calibration records - Monsanto will retain documentation for a specified period of time on the 
equipment calibration including the procedure, when it was conducted and the results. 
 
 Blend proportion records (weight and kernel based) - Monsanto will retain documentation for a 
specified period of time on the kernel per pound data of the components, the calculations to 
determine the proportions based on weight and the actual weights that are blended together to 
make up an MON 89034 x TC1507 Seed Blend corn product by seed lot. 
 
All records must be maintained at the Monsanto blending facility and must be available for the EPA review 
upon request. 
 
f. Annual Reporting Requirements for MON 89034 x TC1507 Seed Blend corn 
 
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, Cry1F, and Cry2Ab2): results of monitoring and 
investigations of damage reports, August 31st of each year. 
 
 
Should you wish to add/retain a reference to your company’s website on your label, then please be aware that 
the website becomes labeling under FIFRA and is subject to review by the EPA. If the website is false or 
misleading, the product will be considered to be misbranded and sale or distribution of the product is unlawful 
under FIFRA section 12(a)(1)(E). 40 CFR § 156.10(a)(5) lists examples of statements the EPA may consider 
false or misleading. In addition, regardless of whether a website is referenced on your product’s label, claims 
made on the website may not substantially differ from those claims approved through the registration process. 
Therefore, should the EPA find or if it is brought to our attention that a website contains false or misleading 
statements or claims substantially differing from the EPA-approved registration, the website will be referred to 
the EPA’s Office of Enforcement and Compliance Assurance.

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OPP Decision No. 542180   
 
 
Your release for shipment of this product constitutes acceptance of these conditions. If you fail to satisfy these 
terms and conditions, the EPA will consider appropriate regulatory action including, among other things, 
cancellation under FIFRA section 6(e). 
 
A stamped copy of the label is enclosed for your records. A previously approved Confidential Statement of 
Formula dated November 14, 2013 is on file for this product. 
 
 
 
 S i n c e r e l y , 
 
 
 A l a n R e ynolds, Team Leader 
 M i c r o b i a l P e s t i c i d e s B r a n c h 
Biopesticides and Pollution 
 P r e v e n t i o n D i v i s i o n ( 7 5 1 1 P ) 
Office of Pesticide Programs 
 
 
Enclosure

Plant-Incorporated Protectant Label 
 
MON 89034 × TC1507 Seed Blend 
 
 
Insect-Protected, Herbicide-Tolerant Corn with an Interspersed Refuge 
(OECD Unique Identifier: MON-89Ø34-3 × DAS-Ø15Ø7-1) 
 
Active Ingredients: 
Bacillus thuringiensis Cry1A.105 protein and the genetic material (vector PV-ZMIR245) 
necessary for its production in corn event MON 89034 (OECD Uniq ue Identifier: MON-
89Ø34-3) ........................................................................................................... ≤ 0.0026%* 
 
Bacillus thuringiensis Cry2Ab2 protein and the genetic material (vector PV-ZMIR245) 
necessary for its production in corn event MON 89034 (OECD Uniq ue Identifier: MON-
89Ø34-3) ........................................................................................................... ≤ 0.0053%* 
 
Bacillus thuringiensis Cry1F protein and the genetic material (vector PHP8999) 
necessary for its production in corn event TC1507 (OECD Unique Identifier: DAS- 
Ø15Ø7-1) .......................................................................................................... ≤ 0.0012%* 
 
Other Ingredients: 
The marker protein, Phosphinothricin Acetyltransferase (PAT), a nd the genetic material 
(vector PHP8999) necessary for its production in corn event TC1507(OECD Unique 
Identifier: DAS- Ø15Ø7-1) ............................................................................ ≤ 0.00045%* 
 
*Maximum percent (wt/wt) of dry forage 
 
MON 89034 × TC1507 Seed Blend contains 95% MON 89034 x TC1507 mixed with at 
least 5% non-B.t. corn within a single lot of seed. 
 
KEEP OUT OF REACH OF CHILDREN 
 
CAUTION 
EPA Registration No. 524-612 
EPA Establishment No. 524-MO-002 
 
Monsanto Company 
800 North Lindbergh Blvd. 
St. Louis, MO 63167 
 
 
NET CONTENTS_______ 
 
 
11/07/2018
524-612

DIRECTIONS FOR USE 
 
It is a violation of Federal law to use this seed in any manner inconsistent with this 
labeling. Information regarding commercial production must be i ncluded in the 
Technology Use Guide and/or Insect Resistance Management (IRM) Grower Guide. 
 
MON 89034 x TC1507 Seed Blend can be used to protect corn plant s from leaf, stalk, 
and ear damage caused by lepidopteran corn pests listed on this label. To help preserve 
the effectiveness of B.t. corn technologies, growers planting MON 89034 x TC1507 Seed 
Blend are required to follow an Insect Resistance Management (IRM) Plan. 
 
Grower agreements will specify that growers must adhere to the refuge requirements that 
will be described on the bag or bag-tag for MON 89034 x TC1507 Seed Blend corn or 
other applicable product use documents. 
 
Sales of corn hybrids that contain Monsanto’s B.t. corn plant-incorporated protectants 
must be accompanied by information on planting, production, and insect resistance 
management. This information may appear on either an IRM Growe r Guide or on the 
corn seed bag or bag-tag. 
 
Corn seed bags or bag-tags for products containing MON 89034 x TC1507 Seed Blend 
must include the refuge requirement. 
 
INSECT RESISTANCE MANAGEMENT 
 
Growers are instructed to read information on insect resistance management in the IRM 
Grower Guide or the bag or bag-tag. 
 
This product is a seed mixture containing up to 95% MON 89034 × TC1507 and a minimum 
of 5% non-B.t. seed that when planted creates an interspersed refuge within the field. There 
are no requirements for a separa te structured refuge for MON 89 034 × TC1507 Seed Blend 
corn when planted in the U.S. corn growing area, including Alas ka and Hawaii, because the 
refuge seed is contained within the bag/container. 
The i n t e rspersed refuge can only be u sed b y planting seed corn specifically generated by 
qualified seed producers/conditioners licensed by the registran t. The seed producer must 
ensure a minimum of 5% non -B.t. refuge seed is included with the MON 89034 × 
TC1507 in each lot of seed corn. 
 
The 95/5% MON 89034 x TC1507 Seed Blend product may be planted in cotton growing 
areas; however, planting the 95/5% MON 89034 x TC1507 Seed Blend in cotton growing 
areas still requires planting an additional 20% structured refu ge (block, strips, or border) 
as defined for MON 89034 x TC1507 EPA Registration No. 524-585. The interspersed 
refuge option for MON 89034 x TC1507 Seed Blend does not alone comply with 
refuge requirements in cotton growing areas.

Additional refuge requirements in the cotton-growing area where corn earworm is a 
significant pest 
 
In the cotton-growing area, as defined below, MON 89034 × TC150 7 Seed Blend 
requires the planting of an additional 20% structured refuge (i.e. 20 acres of non-B.t. corn 
for every 80 acres of MON 89034 × TC1507 Seed Blend planted). 
The 20% refuge must be planted with corn hybrids that do not co ntain B.t. technologies 
for the control of lepidopteran pests. 
The 20% refuge and the MON 89034 × TC1507 Seed Blend should be sown on the same 
day, or with the shortest window possible between planting date s to ensure that corn root 
development is similar among varieties. The 20% refuge may be p lanted as an in-field or 
adjacent (e.g., across the road) refuge or planted as a separat e block that is within 
1/2 mile of the MON 89034 × TC1507 Seed Blend field. In-field r efuge options include 
blocks, perimeter strips (i.e., strips around the field), or in -field strips. If perimeter or in-
field strips are implemented, the strips must be at least 4 con secutive 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 pests of MON 89034 × TC1507 Se ed Blend in the 
refuge exceeds economic thresholds. Insecticide treatments for control of insects listed 
on this label may be applied only if economic thresholds are re ached for one or more of 
these target pests. Economic thresholds will be determined using methods recommended 
by local or regional professionals (e.g., Extension Service age nts, crop consultants). 
Microbial B.t. insecticides must not be applied to the field containing a see d mix 
interspersed refuge. 
The cotton-growing area requiring the additional 20% refuge con sists of 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, and Washita), Tenn essee (only the 
counties of Carroll, Chester, C rockett, Dyer, Fayette, Franklin , Gibson, Hardeman, 
Hardin, Haywood, Lake, Lauderdale, Lincoln, Madison, Obion, Rut herford, Shelby, and 
Tipton), Texas (except the counties of Carson, Dallam, Hansford , Hartley, Hutchinson, 
Lipscomb, Moore, Ochiltree, Roberts, and Sherman), Virginia (on ly the counties of 
Dinwiddie, Franklin City, Greensville, Isle of Wight, Northampt on, Southampton, 
Suffolk City, Surrey, and Sussex) and Missouri (only the counti es of Dunklin, New 
Madrid, Pemiscot, Scott, and Stoddard).

Corn Insects Controlled or Suppressed 
 
European corn borer (ECB) Ostrinia nubilalis 
Southwestern corn borer (SWCB) Diatraea grandiosella 
Southern cornstalk borer (SCSB) Diatraea crambidoides 
Corn earworm (CEW) Helicoverpa zea 
Fall armyworm (FAW) Spodoptera frugiperda 
Stalk borer Papaipema nebris 
Lesser corn stalk borer Elasmopalpus lignosellus 
Sugarcane borer (SCB) Diatraea saccharalis 
Black cutworm Agrotis ipsilon 
 
MON 89034 × TC1507 Seed Blend is a product of Monsanto’s and Dow AgroSciences’ 
research programs, offering unique genetic characteristics for specific grower needs and 
may be protected by one or more U.S. patents found at the following web page: 
www.monsantotechnology.com