Files
crop-chem-docs/corpus/epa_ppls/524-595.md
T
justin a97107de46
Image rebuild (skip scrape) / build (push) Failing after 1h37m12s
docker: production image + Gitea Actions for monthly refresh
Dockerfile: self-contained image with corpus + Chroma + BM25 baked
in. Drawbar's compose pulls + runs without volume mounts. Built from
sources.json (labels schema), PRODUCT_NAME=crop_chem by default,
HYBRID_SEARCH=true (always-on for production quality). RERANK_URL +
OLLAMA_URL get set at compose time.

.gitea/workflows/refresh.yml: monthly cron (1st @ 06:00 UTC) does
full scrape → reindex → image push. Scrapes Bayer (~30 min) +
EPA PPLS row-crop filtered (~7h). Skips reindex+push if no corpus
diff. Tags pushed: :latest, :<sha12>, :corpus-<YYYY.MM.DD>.

.gitea/workflows/image-only.yml: on-demand or auto on code-only
pushes to main (paths: docs_mcp/, rag/, scrape/, requirements.txt,
Dockerfile, sources.json). Reindexes from committed corpus, builds
image, pushes. ~10 min vs ~9h full refresh.

.gitignore: corpus/ now COMMITTED (4,159 labels, 265 MB of .md +
sidecars). Lets image-only.yml rebuild indexes without re-scraping.
chroma/ + bm25/ still gitignored (regenerable binary indexes).

.dockerignore: drops venv, eval results, PLAN/README/CLAUDE.md,
deploy/, .git/ — keeps the image lean. corpus + chroma + bm25
explicitly NOT in dockerignore (those go INTO the image).

Co-Authored-By: Claude Opus 4.7 (1M context) <noreply@anthropic.com>
2026-05-24 12:32:41 -04:00

1062 lines
73 KiB
Markdown
Raw Blame History

This file contains invisible Unicode characters
This file contains invisible Unicode characters that are indistinguishable to humans but may be processed differently by a computer. If you think that this is intentional, you can safely ignore this warning. Use the Escape button to reveal them.
This file contains Unicode characters that might be confused with other characters. If you think that this is intentional, you can safely ignore this warning. Use the Escape button to reveal them.
# MON 89034 X TC1507 X MON 88017 X DAS-59122-7 SEED BLEND
- EPA Reg No: **524-595**
- 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 Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for their production in corn (0.0236%); Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary (vector ZMIR39) for its production in corn (0.0079%); 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: 2018-11-05
- Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00595-20181105.pdf
---
EPA Form 8570-6
U.S. ENVIRONMENTAL PROTECTION AGENCY
Office of Pesticide Programs
Biopesticides and Pollution Prevention Division (7511P)
1200 Pennsylvania Ave., N.W.
Washington, D.C. 20460
EPA Reg. Number:
524-595
Date of Issuance:
11/5/2018
NOTICE OF PESTICIDE:
X Registration
Reregistration
Term of Issuance:
Unconditional
(under FIFRA, as amended) Name of Pesticide Product:
MON 89034 × TC1507 × MON
88017 × DAS-59122-7 Seed Blen
d
Name and Address of Registrant (include ZIP Code):
Monsanto Company
800 North Lindbergh Blvd
St. Louis, Missouri 63167
Note: Changes in labeling differing in substance from that accepted in connection with this registration must be submitted to and accepted by the Biopesticides
and Pollution Prevention Division prior to use of the label in commerce. In any correspondence on this product, always refer to the above EPA Registration
Number.
On the basis of information furnished by the registrant, the above-named pesticide is hereby registered
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA or the Act).
Registration is in no way to be construed as an endorsement or recommendation of this product by the U.S.
Environmental Protection Agency (EPA). In order to protect health and the environment, the Administrator,
on his or her motion, may at any time suspend or cancel the registration of a pesticide in accordance with
the Act. The acceptance of any name in connection with the registration of a product under the Act is not to
be construed as giving the registrant a right to exclusive use of the name or to its use if it has been covered
by others.
This product is unconditionally registered in accordance with FIFRA section 3(c)(5) provided that you
comply with the following terms:
1. The subject registration will automatically expire at midnight on November 30th, 2026.
Signature of Approving Official:
Alan Reynolds, Team Leader
Emerging Technologies Branch
Biopesticides and Pollution Prevention Division (7511P)
Date:
11/5/2018
Page 2 of 21
EPA Reg. No. 524595
OPP Decision No. 542182 
2. The subject registration will be limited to 95% Bacillus thuringiensis Cry1A.105 protein and the genetic
material necessary for its production (vector PV-ZMIR245), Bacillus thuringiensis Cry2Ab2 protein and
the genetic material necessary for its production (vector PV-ZMIR245), Bacillus thuringiensis Cry1F
protein and the genetic material necessary for its production (vector PHP8999), Bacillus thuringiensis
Cry3Bb1 protein and the genetic material necessary for its production (vector PV-ZMIR39) and Bacillus
thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for their production
(vector PHP17662) in MON-89034 × TC1507 × MON-88017 × DAS-59122-7 (OECD Unique
Identifier: MON-89Ø34-3 × DAS- Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7) and 5% non-Bt 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 protect ant (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 must commit to do the following Insect Resistance Management (IRM) Program, consisting of
the following elements:
 Requirements for Monsanto to implement an IPM-based stewardship program designed to
reduce selection pressure for corn rootworm (CRW) resistance.
 Requirements relating to a refuge assurance program for ensuring the correct refuge blend
percentage.
 Requirements relating to creation of a lepidopteran refuge (consisting of corn that does not
contain any Bt trait for lepidopteran control) in cotton growing regions in conjunction with the
planting of any acreage of MON 89034 x TC1507 x MON 88017 x DAS-59122-7 Seed Blend
corn;
 Requirements for Monsanto to prepare and require MON 89034 x TC1507 x MON 88017 x
DAS-59122-7 Seed Blend corn users to sign grower agreements that impose binding
contractual obligations 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 Cry1F, Cry1A.105, 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 Cry1F, Cry1A.105, or Cry2Ab2 was detected, as well as to report on activity
Page 3 of 21
EPA Reg. No. 524595
OPP Decision No. 542182 
under the plan to EPA.
 Requirements for Monsanto to investigate reports of unexpected CRW damage to MON
89034 x TC1507 x MON 88017 x DAS-59122-7 Seed Blend corn from growers
(“performance inquiries”) and sample CRW to determine if the insects are resistant to
Cry3Bb1 or Cry34/35Ab1.
 Requirements for Monsanto to recommend CRW management options to growers in response
to cases of unexpected CRW damage to MON 89034 x TC1507 x MON 88017 x DAS-59122-
7 Seed Blend corn.
 Requirements regarding mitigation and notification actions that Monsanto would take in
the event that CRW resistance was detected.
 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
Agencys request.
 Bag Tag Requirements for MON 89034 x TC1507 x MON 88017 x DAS-59122-7 Seed Blend
corn: Seed bags and/or bag tags for corn hybrids that contain plant- incorporated protectants
produced in MON 89034 x TC1507 x MON 88017 x DAS-59122-7 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.
 Requirements for Monsanto to submit reports on CRW IPM stewardship and resistance
monitoring within the time frames specified in this registration notice.
a. Integrated Pest Management Stewardship Program
1. Monsanto must implement an IPM-based stewardship program for MON 89034 x TC1507 x MON 88017 x
DAS-59122-7 Seed Blend corn. This program must be designed to reduce selection pressure for corn
rootworm (CRW) resistance by encouraging growers to engage in a multi-year crop rotation strategy
involving the use of one or more of the following: a non-CRW host crop (e.g., soybean), pyramided Bt corn
Plant Incorporated Protectants (PIPs), other PIP corn products with different modes of action, and/or non-Bt
or non-CRW protected Bt corn. As part of the stewardship program, Monsanto must update the technology
use guide/grower guide and other grower educational materials to indicate that application of an insecticide
to the soil surface, in furrows, and/or incorporated into the soil (referred to as “soil applied insecticide”,
“soil insecticide” or “SAI”) with MON 89034 x TC1507 x MON 88017 x DAS-59122-7 Seed Blend corn is
not recommended for control of CRW except under limited circumstances and in consultation with
extension, crop consultants or other local experts. Grower education materials should also state that SAIs
should not be necessary for CRW control with pyramided CRW trait Bt corn product(s). As part of the
stewardship program, Monsanto must promote the ABSTC/NCGA Best Management Practices (BMPs) for
CRW control. Implementation of the IPM strategy can include:
 Grower education initiatives or incentives.
 Outreach to extension and consultant groups.
Page 4 of 21
EPA Reg. No. 524595
OPP Decision No. 542182 
2. Monsanto must submit an annual report to EPA documenting activities conducted under the IPM
stewardship program. This report must include an anonymous survey of grower practices, including
adoption levels of the various crop rotation options (if employed) and other elements of the stewardship
program. Monsanto may combine this product with other registered products to submit one annual report.
The report must be submitted by January 31
st each year.
b. Refuge Requirements for MON 89034 x TC1507 x MON 88017 x DAS-59122-7 Seed Blend Corn
The following information must be included on the product bag or bag-tag as sold per respective region and in
the Grower Guide:
Corn Belt/Non-Cotton Growing Areas
MON 89034 x TC1507 x MON 88017 x DAS-59122-7 Seed Blend contains a Lepidopteran and corn rootworm
refuge that is “in the bag” and is automatically implemented when the grower plants the product. No additional
refuge is required when planting this product.
Foliar insecticide treatments for control of European corn borer, corn earworm, southwestern corn borer, fall
armyworm, black cutworm, western bean cutworm, lesser corn stalk borer, southern corn stalk borer, stalk borer
and sugarcane borer may be applied only if economic thresholds are reached for one or more of these target
pests. Foliar insecticide treatments are also permitted for control of corn rootworm adults if economic
thresholds are reached. Economic thresholds will be determined using methods recommended by local or
regional professionals (e.g., Extension Service agents, crop consultants).
Cotton-Growing Region Refuge Requirements
These refuge requirem
ents 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 x MON 88017 x DAS-59122-7 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 x MON 88017 x DAS-59122-7 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.
Page 5 of 21
EPA Reg. No. 524595
OPP Decision No. 542182 
 Foliar insecticide treatments for control of European corn borer, corn earworm, southwestern corn borer,
fall armyworm, black cutworm, western bean cutworm, lesser corn stalk borer, southern corn stalk
borer, stalk borer and sugarcane borer may be applied only if economic thresholds are reached for one or
more of these target pests. Economic thresholds will be determined using methods recommended by
local or regional professionals (e.g., Extension Service agents, crop consultants). Microbial Bt
insecticides must not be applied to non-Bt corn refuge plants.
 Cotton-growing areas include the following states: Alabama, Arkansas, Georgia, Florida, Louisiana,
North Carolina, Mississippi, South Carolina, Oklahoma (only counties of Beckham, Caddo, Comanche,
Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, and Washita), Tennessee (only the counties of
Carroll, Chester, Crockett, Dyer, Fayette, Franklin, Gibson, Hardeman, Hardin, Haywood, Lake,
Lauderdale, Lincoln, Madison, Obion, Rutherford, Shelby, and Tipton), Texas (except the counties of
Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, Moore, Ochiltree, Roberts, and Sherman),
Virginia (only the counties of Dinwiddie, Franklin City, Greensville, Isle of Wight, Northampton,
Southampton, Suffolk City, Surrey, and Sussex) and Missouri (only the counties of Dunklin, New
Madrid, Pemiscot, Scott, and Stoddard).
c. Grower Agreements for MON 89034 x TC1507 x MON 88017 x DAS-59122-7 Seed Blend Corn
1. Persons purchasing MON 89034 x TC1507 x MON 88017 x DAS-59122-7 Seed Blend 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. 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 x MON 88017 x DAS-59122-7 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 it s current grower agreement for MON 89034 x TC1507 x MON 88017 x
DAS-59122-7 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 x MON 88017 x DAS-59122-7 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 x MON 88017 x DAS-59122-7 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 Agencys request.
Page 6 of 21
EPA Reg. No. 524595
OPP Decision No. 542182 
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.
d. IRM Education and IRM Compliance Monitoring Program for MON 89034 x TC1507 x MON
88017 x DAS-59122-7 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 x MON 88017 x DAS-
59122-7 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 x MON 88017 x DAS-
59122-7 Seed Blend corn users to pursue optional elements of the IRM program relating to refuge
configuration and proximity to MON 89034 x TC1507 x MON 88017 x DAS-59122-7 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 x MON 88017 x DAS-59122-7 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
collected through the compliance survey, required under paragraphs 69 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
Agencys request. The required features of the compliance assurance program are described in paragraphs
422 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 x MON 88017 x DAS-59122-7
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 Monsantos 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 522 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
Page 7 of 21
EPA Reg. No. 524595
OPP Decision No. 542182 
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 Monsantos 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 a biennial survey, conducted by an independent third
party, of a statistically representative sample of growers MON 89034 x TC1507 x MON 88017 x DAS-
59122-7 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 x MON 88017
x DAS-59122-7 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
Monsantos sales of integrated refuge products are equal to or greater than 70% of Monsantos total Bt corn
sales in the prior year, then no anonymous grower survey is required in the U.S. Corn Belt. If Monsantos
sales of integrated refuge products fall below 70% of Monsantos 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 Monsantos 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 designe d 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 u sefulness 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
Page 8 of 21
EPA Reg. No. 524595
OPP Decision No. 542182 
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 69 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 x MON 88017 x DAS-59122-7 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 x MON 88017 x DAS-59122-7 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 x MON 88017 x DAS-59122-7 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 x MON 88017 x DAS-59122-7 Seed Blend compliance assurance program activities and
results for the prior year and plans for the MON 89034 x TC1507 x MON 88017 x DAS-59122-7 Seed
Blend compliance assurance program for the current year. Within one month of submitting this report to
EPA, the Monsanto 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. 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 x MON 88017
Page 9 of 21
EPA Reg. No. 524595
OPP Decision No. 542182 
x DAS-59122-7 Seed Blend sold and delivered. The purpose of this bag tag is to remind growers
that MON 89034 x TC1507 x MON 88017 x DAS-59122-7 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 x MON 88017 x
DAS-59122-7 Seed Blend is used.
19. Monsanto will use its available MON 89034 x TC1507 x MON 88017 x DAS-59122-7 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 x MON 88017 x DAS-59122-7 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 x MON
88017 x DAS-59122-7 Seed Blend corn product to reflect the adoption rate and level of refuge compliance
for the product.
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 Monsantos 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.
Page 10 of 21
EPA Reg. No. 524595
OPP Decision No. 542182 
e. Insect Resistance Monitoring and Mitigation Plan for MON 89034 x TC1507 x MON 88017 x
DAS-59122-7 Seed Blend Corn
1. EPA is imposing the following conditions for the Cry1F, Cry1A.105, and Cry2Ab2 toxins expressed
in MON 89034 x TC1507 x MON 88017 x DAS-59122-7 Seed Blend
Monsanto w
ill monitor for resistance to Cry1F, Cry1A.105, or Cry2Ab2 expressed in MON 89034 x TC1507
x MON 88017 x DAS-59122-7 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 sam
ple and bioassay populations of the key target pests: Ostrinia nubilalis
(European corn borer; ECB), Diatraea grandiosella (southwestern corn borer; SWCB), and Helicoverpa zea
(corn earworm; CEW). Sampling for the target pests will be focused in areas identified as those with the
highest risk of resistance development (e.g., where lepidopteran active Bt hybrids are planted on a high
proportion of the corn acres, and where the insect species are regarded as key pests of corn). Bioassay
methods must be appropriate for the goal of detecting field-relevant shifts in population response to MON
89034 x TC1507 x MON 88017 x DAS-59122-7 Seed Blend corn and/or changes in resistance allele
frequency in response to the use of MON 89034 x TC1507 x MON 88017 x DAS-59122-7 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
population collection will contain a minimum of 100 genomes. It is recognized that it may not be possible to
collect the target number of insect populations or genomes due to factors such as natural fluctuations in pest
density, environmental conditions, and area-wide pest suppression.
The sampling program and geographic range of collections may be modified as appropriate based on changes
in pest importance and for the adoption levels of MON 89034 x TC1507 x MON 88017 x DAS-59122-7
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 Cry1F, 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
Page 11 of 21
EPA Reg. No. 524595
OPP Decision No. 542182
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 x MON 88017 x DAS-59122-7 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 resistance 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 w
ill 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
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 m
ean 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;
Page 12 of 21
EPA Reg. No. 524595
OPP Decision No. 542182 
 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 x MON 88017
x DAS-59122-7 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 x MON 88017 x DAS-59122-7 Seed
Blend corn fields in the affected region to control the target pest during the immediate growing
season.
 Destroy MON 89034 x TC1507 x MON 88017 x DAS-59122-7 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 m
ean, in the case of field reports of unexpected levels of damage from
the key target pests, that all the following criteria are met:
 There is >30% insect survival and commensurate insect feeding in a bioassay, initiated with
neonate larvae, that uses methods that are representative of exposure to Bt corn hybrids under field
conditions (ECB and SWCB only).
 In standardized laboratory bioassays using diagnostic concentrations of the Bt protein suited to the
target pest in question, the pest exhibits resistance that has a genetic basis and the level of survivorship
indicates that there may be a resistance allele frequency of ≥ 0.1 in the sampled population.
 In standardized laboratory bioassays, the LC50 exceeds the upper limit of the 95% confidence
interval of the LC50 for susceptible populations surveyed both in the original baselines developed for
this pest species and in previous years of field monitoring.
Page 13 of 21
EPA Reg. No. 524595
OPP Decision No. 542182 
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 fo
llowing 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.
2. EPA is imposing th
e following conditions for the Cry3Bb1 and Cry34/35Ab1 toxins expressed in
MON 89034 x TC1507 x MON 88017 x DAS-59122-7 Seed Blend corn:
a) Investigation of Reports of Unexpected Levels of Damage (UXD) by Corn Rootworm (CRW):
Performance Inquiries
(1) Monsanto is required to investigate "perform
ance inquiries" (i.e., reports of unexpected CRW
damage to MON 89034 x TC1507 x MON 88017 x DAS-59122-7 Seed Blend corn) from
growers. Fields (defined as a tract separated by permanent boundaries such as fences,
Page 14 of 21
EPA Reg. No. 524595
OPP Decision No. 542182 
permanent waterways, woodlands, croplines not subject to change because of farming
practices, or other similar features) with unexpected damage that meet both of the criteria
below must be subjected to the follow-up actions in part 2) below:
a. The affected plants are confirmed to be MON 89034 x TC1507 x MON 88017 x DAS-
59122-7 Seed Blend corn plants (take leaf samples to determine the presence of the
CRW-active Bt protein); and
b. Corn rootworm feeding caused root damage with a Node Injury Score (NIS) > 0.5 on
at least 50% of plants surveyed in a transect sampling of the damaged site(s) within the
field.
(2) Follow-up actions (performance inquiries). For MON 89034 x TC1507 x MON 88017 x DAS-
59122-7 Seed Blend corn fields meeting the criteria in part 1) above, Monsanto must take the
following actions:
a. Collect at least 250 (ideally 500 or more) CRW adult individuals from the damaged
site within the field in question. Collections may be extended to the whole field, if
necessary to obtain sufficient CRW adult individuals. Collected populations must be
subjected to the steps described for "investigation of populations of concern" in section
e(2)(b) below.
o If collections are unsuccessful, visit affected farm or field the following year
(assuming the grower continues to be a customer and repurchases seed and does
not rotate the field to a non-host crop) and attempt to collect CRW adults. If beetles
are not present the subsequent year, see section e(2)(b)(3)(c) below.
b. Review with the grower their CRW management practices and provide CRW
management recommendations including an assessment of corn fields with similar
trait(s) adjacent to the affected corn field that are managed by the same grower.
c. Use of single trait products containing the CRW traits in MON 89034 x TC1507 x
MON 88017 x DAS-59122-7 Seed Blend in fields with unexpected damage in
previous years should be discouraged. Recommended management options include,
but are not limited to, the following:
o Primary option: Rotation to a non-host crop (e.g., soybean)
o Secondary options:
• Use of pyramided Bt corn products one or more different CRW PIP trait(s)
• Use of different single-CRW PIP traits (i.e., an alternative CRW-active PIP)
• Use of non-Bt or non-CRW protected corn
o Tertiary options:
• If additional pest management need is determined beyond the secondary
Page 15 of 21
EPA Reg. No. 524595
OPP Decision No. 542182 
options listed above, use of the same pyramided Bt corn product is acceptable if
it is very unlikely that both of the traits are affected (e.g., the affected field
experienced UXD to one of the traits in the product in the previous year, the
NIS is less than 1.0, there has been no continuous use of the second trait in the
product in the affected field, and Monsanto has not been informed of resistance
to the second trait in the county)
• Additional corn rootworm control tools (e.g., soil applied insecticides,
chemigation) should be considered
d. If field(s) with UXD is/are planted to a non-host crop (e.g., soybean) the following
year, then the area will be considered “mitigated” (as discussed in section e(2)(b)(3)(d)
below) even if subsequent bioassay results show that the population was resistant. No
further action will be required by Monsanto for the UXD case.
(3) Monsanto must submit an annual report to EPA detailing activities related to investigations of
unexpected damage (UXD). This report will include the information from the most recent and
previous corn growing seasons:
a. Information from the most recent season:
o The number of UXD reports investigated.
o Location (by county and state).
o CRW sampling (number and location of populations collected).
b. Information from the previous season:
o The final disposition of UXD fields from the previous season (i.e., the management
practices employed in response to UXD if the grower continues to be a customer.
o Results from bioassays conducted on CRW populations from UXD fields where the
primary management option, rotation to non-host crop, was not used.
c. Grower information, such as farm addresses or other personally identifiable information,
or other sensitive business/customer information must not be included in this report. This
report must be submitted by November 30th each year.
b) Investigation of Population of Concern
1. Monsanto must conduct investigations of all CRW populations collected as part of the perform
ance
inquiry process in section e(2)(a) above. These investigations must include the use of an EPA-approved
bioassay to determine if sampled CRW populations are resistant to any of the CRW PIP toxins in MON
89034 x TC1507 x MON 88017 x DAS-59122-7 Seed Blend. Acceptable assays must be able to
function as diagnostic tools capable of distinguishing resistant populations from susceptible ones.
Unless previously approved, Monsanto must consult with EPA on their bioassay prior to its use.
2. A CRW population will be considered by EPA to be resistant to a CRW PIP toxin if the following
Page 16 of 21
EPA Reg. No. 524595
OPP Decision No. 542182 
criteria are met and additional collections and testing are not deemed to be necessary (based on part 3)
below):
a. An initial performance inquiry investigation results in a finding of Unexpected Damage; and
b. Where green tissues are available and if plants are unusually stressed due to agronomic and/or
environmental factors, Bt protein levels in affected plants are found to be within the
documented range for that hybrid (if data are available); and
c. Either (A): On-plant bioassays of insect collections from the UXD fields result in the
following two statistically relevant comparisons
i. A statistically significant difference in measures of either mortality or sublethal effects
(growth/development) between the field population and a relevant susceptible control
population (i.e., one that responds as a typical susceptible field population) on Bt corn
containing the single PIP and/or lack of a statistically significant difference in measures
of mortality or sublethal effect between the field population and a resistant positive
control population1; and
ii. A lack of a statistically significant difference in the same measures of the field population
raised on Bt corn containing the single PIP and non-Bt corn plants.
Or (B): Sublethal seedling bioassay of insect collections from the UXD fields result in two
statistically relevant comparisons
i. A statistically significant difference in measures of sublethal effects
(growth/development) for populations on Bt corn containing the single PIP (normalized
using non-Bt) seedlings between the field population and a relevant susceptible control
population where available or historical field populations and/or lack of a statistically
significant difference in measures between the field population and a resistant positive
control population1; and
ii. A lack of a statistically significant difference in the same measures of the field
population raised on Bt corn seedlings containing the single PIP and non-Bt corn
seedlings
Or (C): Diet-based bioassays of insect collections from the UXD fields result in two
statistically relevant comparisons
i. A statistically significant difference in measures of lethal or sublethal effects
(growth/development) on diet containing the Bt protein (diagnostic concentration or
concentration-response measures) between the field population and a relevant
susceptible control population where available or historical field populations and/or
lack of a statistically significant difference in measures between field population and a
resistant positive control population1; and
ii. Either a lack of a statistically significant difference in the same measures of the field
1 If a resistant positive control population is not available or accessible, Monsanto must consult with EPA prior to initiating bioassays
and work to develop an appropriate resistant positive control population.
Page 17 of 21
EPA Reg. No. 524595
OPP Decision No. 542182 
population exposed to diet containing the Bt protein (diagnostic concentration) and diet
not containing the Bt protein and/or lack of a statistically significant difference in
measures between the field population and a resistant positive control population, or
lack of a statistically significant concentration and/or lack of a statistically significant
difference in concentration response between the field and a resistant positive control
population1.
3. Mitigation, as detailed in section e(2)(c) below, is required for any CRW population that meets EPAs
resistance criteria above for any of the CRW traits in MON 89034 x TC1507 x MON 88017 x DAS-
59122-7 Seed Blend, unless the circumstances described below are applicable.
a. To minimize the potential for incorrectly reaching a conclusion of resistance, another year of
CRW adult collections and additional testing is needed to determine resistance if:
i. The results of the bioassays are inconclusive (e.g., the results of the statistical analysis are
unclear because of low sample sizes) or
ii. Another reasonable explanation for the unexpected damage exists (e.g., high pest pressure
and/or high plant stress).
b. In these cases, Monsanto and EPA will discuss and align on next steps before reaching any
resistance conclusion.
c. If CRW collections are not possible in the current year or subsequent year due to successful
management practices, then no further investigation is needed. The population would be
considered "mitigated" meaning, in this case, that the population is suppressed or extirpated for
the UXD field. However, EPA recommends that Monsanto continue to be vigilant in areas where
CRW populations were successfully mitigated.
d. If a UXD field receives non-host crop (e.g., soybean) rotation the following year as described in
Section e(2)(a)(2) above, no additional mitigation is subsequently required.
c) Mitigation of CRW Populations Meeting EPAs Resistance Criteria
1. For any CRW population found to be resistant to one or m
ore of the CRW traits in MON 89034 x
TC1507 x MON 88017 x DAS-59122-7 Seed Blend under EPAs criteria described in section e(2)(b)
above, Monsanto must take the following steps:
a) Monsanto must inform EPA of all the results of the bioassays as soon as possible, but at least
within 30 days if measures are triggered.
b) The mitigation action area (MAA) is defined as the growers farming operation up to a ½ mile
radius from the damaged site that produced the resistant population.
c) Within 30 days of informing EPA of the results of the bioassays, Monsanto must notify state
extension agents and crop consultants who operate within the county in which resistance was
identified. Information shared must include identification of the county in which resistance was
detected and trait(s) affected.
d) Within the MAA, Monsanto must do the following:
Page 18 of 21
EPA Reg. No. 524595
OPP Decision No. 542182 
i. Prior to finalizing the growers seed order for the following season, inform the affected
grower and other registrants that hold registrations containing the compromised trait(s).
Monsanto must also inform neighboring growers if those growers are customers of
Monsanto. Information shared must include identification of the county in which
resistance was detected and trait(s) affected;
ii. Discontinue sales/planting of products containing the compromised trait(s) without
additional/alternative (i.e. non-compromised) CRW traits until resistance has been
demonstrated to have been mitigated. Other Bt registrants selling such products in the
MAA are encouraged, but cannot be required, to follow suit;
iii. Monsanto must monitor the resistant population in the MAA, as long as grower remains a
customer of the company, until mitigation has been demonstrated as described in part e
below unless otherwise agreed with EPA.
iv. Require any pyramids sold by Monsanto containing the compromised trait(s) be planted
with a 20% refuge until resistance has been demonstrated to have been mitigated. Other
Bt corn registrants selling such pyramided products in the MAA are encouraged, but
cannot be required by this term of registration, to follow suit;
v. For Monsantos affected customers field(s), the mitigation goal is to control the resistant
CRW population. Within the MAA Monsanto shall encourage the use of “Mitigation
Practices” including:
1. Primary option: Rotation to a non-host crop (e.g., soybean);
2. Secondary options:
a. Use of pyramided Bt corn products with different CRW PIP traits;
b. Only in the case that the resistance definition for one of the CRW traits in the
MON 89034 x TC1507 x MON 88017 x DAS-59122-7 Seed Blend is not
met, continued use of the product with a 20% refuge;
c. Use of different single-CRW PIP traits (i.e., an alternative CRW-active PIP);
d. Use of non-Bt corn or non-CRW protected corn (with/without soil-applied
insecticide);
3. Tertiary options:
a. If additional pest management need is determined beyond the secondary
options listed above, additional CRW control tools (e.g., soil insecticides,
seed-applied insecticides, chemigation) should be used.
b. Use of foliar applications to control adults (when appropriate economic
thresholds have been met) may be used in conjunction with one or more of
the above;
Page 19 of 21
EPA Reg. No. 524595
OPP Decision No. 542182 
e) A resistant CRW population in the MAA will be considered mitigated if one of the following
criteria is met:
i. Corn fields within the MAA are rotated to a non-host crop (e.g. soybean) for one
growing season.
ii. After implementation of mitigation practices (part d.v above), resistance
monitoring (sampling) is conducted but few CRW are found (i.e., <0.1 adults per
plant) and environmental conditions (e.g., weather) are unlikely to be responsible
for the lack of adult CRW presence. If environmental conditions are a factor, then
monitoring should continue for another season.
iii. After implementation practices (part d.v above), resistance monitoring (sampling)
is conducted, CRW are found and collected, and bioassays (section e(2)(b)(2)
above) show that the population susceptibility to the compromised trait(s) has
returned to baseline levels.
f) The mitigation actions in part d above can be lifted, and growers can resume the use of MON
89034 x TC1507 x MON 88017 x DAS-59122-7 Seed Blend corn as a primary tool for CRW
management in the MAA, only when Monsanto demonstrates that successful mitigation as
described in part e above has been achieved.
2. Based on further research to understand CRW resistance to Bt PIPs, EPA will consider refinements to
the resistance mitigation program. Such research may include characterizing the genetics of resistance
(e.g., number of genes, functional dominance, mechanism of resistance, and cross-resistance) and the
biology of resistant insects (e.g., fitness in the presence and absence of the product), and other control
tactics.
f. Refuge Assurance Program for MON 89034 x TC1507 x MON 88017 x DAS-59122-7 Seed Blend
corn
Monsanto must implement a Blended Seed Refuge Assurance Program designed to ensure MON 89034 x
TC1507 x MON 88017 x DAS-59122-7 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
Page 20 of 21
EPA Reg. No. 524595
OPP Decision No. 542182 
make up an MON 89034 x TC1507 x MON 88017 x DAS-59122-7 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.
Should Monsanto or Monsanto's Licensees be notified by the USDA/AMS or State Seed Control Officials that
your seed blend products have been found to have a lower percentage of the refuge component than is
represented on the label, they must notify EPA within 30 days. This would constitute information reportable
under FIFRA section 6(a)(2).
g. Annual Reporting Requirements for MON 89034 x TC1507 x MON 88017 x DAS-59122-7 Seed
Blend corn
The following annual reports must be submitted:
1. Compliance Assurance Plan: Compliance Assurance Program activities, including IRM Grower Survey
results (only for years in which the survey was conducted) and on-farm assessment results for the prior
year and plans for the compliance assurance program for the current year, on or before January 31st each
year.
2. Insect Resistance Monitori ng Results (Cry1A.105, Cry2Ab2, and Cry1F only): results of monitoring and
investigations of damage reports, August 31st of each year.
3. IPM Stewardship Program (Cry3Bb1 and Cry34/35Ab1 only): Activities conducted under the IPM
stewardship program, including an anonymous survey of grower practices, adoption levels of the various
crop rotation options (if employed) and other elements of the stewardship program, on or before January
31st of each year.
4. Unexpected Damage Investigations (Cry3Bb1 and Cry34/35Ab1 only): Activities related to
investigations of unexpected damage (UXD), including number and location of UXD cases, insect
sampling, bioassays, and final disposition of UXD fields from the most recent and previous corn
growing seasons, on or before November 30th of each year.
Should you wish to add/retain a reference to your companys 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 products 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 EPAs 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).
Page 21 of 21
EPA Reg. No. 524595
OPP Decision No. 542182
A stamped copy of the label is enclosed for your records. A previously approved Confidential Statement of
Formula dated November 26, 2013 is on file for this product.
If you have any questions, please contact Matt Weiner by phone at (703) 347-0333 or via email at
weiner.matthew@epa.gov.
S
i n c e r e l y ,
A
l a n R eynolds, Team Leader
E
m e r g i n g T e chnologies Branch
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
Plant-Incorporated Protectant Label
MON 89034 × TC1507 × MON 88017 × DAS-59122-7 Seed Blend
Insect-Protected, Herbicide-Tolerant Corn
(OECD Unique Identifier: MON-89Ø34-3 × DAS- Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7)
Active Ingredients:
Bacillus thuringiensis Cry1A.105 protein and the genetic material necessary for its p roduction
(vector PV-ZMIR245) in MON 89034 × TC1507 × MON 88017 × DAS-591 22-7 corn (OECD
Unique Identifier: MON-89Ø34-3 × DAS- Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7) .................
............................................................................................................................................ ≤ 0.0026%*
Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary for its production (vector
PV-ZMIR245) in MON 89034 × TC1507 × MON 88017 × DAS-59122-7 cor n (OECD Unique
Identifier: MON-89Ø34-3 × DAS- Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7) ........... ≤ 0.0053%*
Bacillus thuringiensis Cry1F protein and the genetic material necessary for its prod uction (vector
PHP8999) in MON 89034 × TC1507 × MON 88017 × DAS-59122-7corn (O ECD Unique Identifier:
MON-89Ø34-3 × DAS- Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7) ............................ ≤ 0.0012%*
Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (vector
PV-ZMIR39) in MON 89034 × TC1507 × MON 88017 × DAS-59122-7 corn (OECD Unique
Identifier: MON-89Ø34-3 × DAS- Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7) ........... ≤ 0.0079%*
Bacillus thuringiensis Cry34Ab1 protein and the genetic material necessary (vector PH P17662) for
its production in MON 89034 × TC1507 × MON 88017 × DAS-59122-7 corn (OECD Unique
Identifier: MON-89Ø34-3 × DAS- Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7) .......... ≤ 0.0194%*
Bacillus thuringiensis Cry35Ab1 protein and the genetic material necessary (vector PH P17662) for
its production in MON 89034 × TC1507 × MON 88017 × DAS-59122-7 corn (OECD Unique
Identifier: MON-89Ø34-3 × DAS- Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7) .......... ≤ 0.0042%*
Other Ingredients:
CP4 EPSPS protein (5-enolpyruvylshikimate-3-phosphate synthase) and the genetic material
necessary (vector PV-ZMIR39) for its production in MON 89034 × TC1507 × MON 88017 × DAS-
59122-7 corn (OECD Unique Identifier: MON-89Ø34-3 × DAS- Ø15Ø7-1 × MON-88Ø17-3 × DAS-
59122-7). ............................................................................................................................ ≤ 0.0052%*
PAT protein (phosphinothricin acetyl transferase) and the genetic material necessary (vectors
PHP17622 and PHP8999) for its production in MON 89034 × TC1507 × MON 88017 × DAS-
59122-7 corn (OECD Unique Identifier: MON-89Ø34-3 × DAS- Ø15Ø7-1 × MON-88Ø17-3 × DAS-
59122-7). .......................................................................................................................... ≤ 0.00045%*
* Percentage (wt/wt) on a dry weight basis for whole plant (forage )
MON 89034 × TC1507 × MON 88017 × DAS-59122-7 Seed Blend with th is refuge
configuration contains 95% MON 89034 × TCI507 × MON 88017 × DAS -59122-7 mixed with
at least 5% non-Bt corn within a single lot of seed.
11/05/2018
524-595
KEEP OUT OF REACH OF CHILDREN
CAUTION
EPA Registration No. 524-595
EPA Establishment No. 524-MO-002
Monsanto Company
800 North Lindbergh Blvd.
St. Louis, MO 63167
NET CONTENTS:__________
DIRECTIONS FOR USE
It is a violation of Federal law to use this product in any man ner inconsistent with its labeling.
This product must be used as specified in the terms and conditions of the registration.
This product may be combined or produced through conventional b reeding with other registered
plant-incorporated protectants (PIPs) that are similarly approv ed for use in combination, through
conventional breeding, with oth er registered PIPs to produce in bred corn lines and hybrid corn
varieties with combined pesticidal traits.
MON 89034 × TC1507 × MON 88017 × DAS-59122-7 Seed Blend protec ts corn crops from
leaf, stalk, and ear damage caused by lepidopteran corn pests listed on this label and root damage
caused by corn rootworm larvae listed on this label. In order to minimize the risk of these pests
developing resistance to MON 89034 × TC1507 × MON 88017 × DAS-5 9122-7 Seed Blend
corn, an insect resistance management (IRM) plan must be implem ented as defined in the
registration terms and conditions.
Grower agreements will specify that growers must adhere to the refuge requirements that will be
described in the IRM/Grower Guide for MON 89034 × TC1507 × MON 88017 × DAS-59122-7
Seed Blend corn or other applicable product use documents.
Sales of corn hybrids that contain Monsanto's Bt corn PIP(s) must be accompanied by an
IRM/Grower Guide which includes information on planting, produc tion, and insect resistance
management and notes that routine applications of insecticides to control these insects are
usually unnecessary when corn containing the Bt proteins is planted.
Corn seed bags or bag tags for products containing MON 89034 × TC1507 × MON 88017 ×
DAS-59122-7 Seed Blend must include the refuge size requirement in text and graphical format.
INSECT RESISTANCE MANAGEMENT
Growers are instructed to read information on insect resistance management in the IRM/Grower
Guide.
These refuge requirements do not apply to seed increase/propaga tion of inbred and hybrid seed
corn up to a total of 20,000 acres per county and up to a combi ned United States (U.S.) total of
250,000 acres per PIP active ingredient per registrant per year.
The following information must be included on the product bag o r bag-tag as sold per respective
region:
Bag or Bag-Tag for the Corn-Growing Region
There are no requirements for a separate structured refuge for MON 89034 × TC1507 ×
MON 88017 × DAS-59122-7 Seed Blend corn when planted in the U.S . corn-growing region.
The refuge seed of MON 89034 × TC1507 × MON 88017 × DAS-59122-7 Seed Blend corn is
contained in the bag, resulting in a refuge configuration that is interspersed within the field. SEE
THE IRM/GROWER GUIDE FOR DETAILED IRM REQUIREMENTS, including t he areas
making up the corn-growing region.
Bag or Bag-Tag for the Cotton-Growing Region
Growers in the cotton-growing region of the U.S. who plant MON 89034 × TC1507 ×
MON 88017 × DAS-59122-7 Seed Blend corn seed are required to pl ant an additional 20%
structured refuge (i.e. 20 acres of non- Bt corn for every 80 acres of MON 89034 × TC1507 ×
MON 88017 × DAS-59122-7 Seed Blend corn planted). The 20% refu ge must be planted with
corn hybrids that do not contain B.t. technologies for the control of corn rootworms or corn
borers. The refuge and the MON 89034 × TC1507 × MON 88017 × DAS -59122-7 Seed Blend
corn should be sown on the same day, or with the shortest windo w possible between planting
dates to ensure that corn root development is similar among var ieties. The structured refuge may
be planted as an in-field or adjacent (e.g., across the road) r efuge, or as a separate block that is
within ½ mile of the MON 89034 × TC1507 × MON 88017 × DAS-59122-7 Seed B lend corn
field. SEE THE IRM/GROWER GUIDE FOR DETAILED IRM REQUIREMENTS, including
the areas making up the cotton-growing region.
The cotton-growing region requiring the additional 20% refuge c onsists 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), Tennessee (only the counties of Carroll, Chester, Crockett,
Dyer, Fayette, Franklin, Gibson, Hardeman, Hardin, Haywood, Lak e, Lauderdale, Lincoln,
Madison, Obion, Rutherford, Shelby, and Tipton), Texas (except the counties of Carson, Dallam,
Hansford, Hartley, Hutchinson, Lipscomb, Moore, Ochiltree, Robe rts, and Sherman), Virginia
(only the counties of Dinwiddie, Franklin City, Greensville, Is le of Wight, Northampton,
Southampton, Suffolk City, Surrey, and Sussex) and Missouri (on ly the counties of Dunklin,
New Madrid, Pemiscot, Scott, and Stoddard).
The following information regarding refuge placement for commer cial production must be
included in the IRM/Grower Guide:
This product includes refuge that is interspersed within the fi eld by planting a licensed seed-
mixture containing MON 89034 × TC1507 × MON 88017 × DAS-59122-7 and a minimum of
5% non-Bt seed. The seed mix refuge option for MON 89034 × TC1507 × MON 88017 ×
DAS-59122-7 Seed Blend satisfies th e refuge requirements in all regions other than in
cotton growing regions where corn earworm is a significant pest as defined above.
The seed producer must ensure a minimum of 5% non- Bt refuge seed is included with the
MON 89034 × TC1507 × MON 88017 × DAS-59122-7 in each lot of see d corn. The
interspersed refuge can only be used by planting seed corn spec ifically generated by qualified
seed producers/conditioners licensed by the registrant. The re fuge seed in the seed mixture may
not be treated with seed-applied insecticides for corn rootworm (CRW) control unless the
MON 89034 × TC1507 × MON 88017 × DAS-59122-7 seed in the seed m ixture receives the
same treatment. Insecticidal treatments labeled for adult CRW control are discouraged during
the time of adult CRW emergence.
Additional refuge requirements in cotton-growing regions where corn earworm is a
significant pest
In cotton-growing regions where corn earworm is a significant p est, as defined above,
MON 89034 × TC1507 × MON 88017 × DAS-59122-7 Seed Blend require s the planting of an
additional 20% structured refuge (i.e., 20 acres of non-Bt corn for every 80 acres of MON 89034
× TC1507 × MON 88017 × DAS-59122-7 Seed Blend planted).
The 20% refuge must be planted with corn hybrids that do not co ntain Bt technologies for the
control of corn rootworms or corn borers. The refuge and the M ON 89034 × TC1507 ×
MON 88017 × DAS-59122-7 Seed Blend should be sown on the same d ay, or with the shortest
window possible between planting dates to ensure that corn root development is similar among
varieties. The structured refuge may be planted as an in-field or adjacent ( e.g., across the road)
refuge, or as a separate block that is within ½ mile of the MON 89034 × TC1507 × MON 88017
× DAS-59122-7 Seed Blend field. In-field refuge options includ e blocks, perimeter strips ( i.e.,
strips around the field), or in-f ield strips. If perimeter or i n-field strips are implemented, the
strips must be at least four (4) consecutive rows wide. The ref uge 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 × TC1507 × MON 88017 × DAS-5912 2-7 Seed Blend in the
refuge exceeds economic thresholds. In addition, the refuge can be protected from CRW damage
by an appropriate seed treatment or soil insecticide; however, insecticides labeled for adult CRW
control must be avoided in the refuge during the period of CRW adult emergence. Economic
thresholds will be determined us ing methods recommended by loca l or regional professionals
(e.g., Extension Service agents, crop consultants).
Corn Insects Controlled or Suppressed
European corn borer (ECB) Ostrinia nubilalis
Southwestern corn borer (SWCB) Diatraea grandiosella
Southern cornstalk borer (SCSB) Diatraea crambidoides
Corn earworm (CEW) Helicoverpa zea
Fall armyworm (FAW) Spodoptera frugiperda
Stalk borer Papaipema nebris
Lesser corn stalk borer Elasmopalpus lignosellus
Sugarcane borer (SCB) Diatraea saccharalis
Black cutworm Agrotis ipsilon
Western corn rootworm (WCRW) Diabrotica virgifera virgifera
Northern corn rootworm (NCRW) Diabrotica barberi
Mexican corn rootworm (MCRW) Diabrotica virgifera zeae
MON 89034 × TC1507 × MON 88017 × DAS-59122-7 Seed Blend is a pr oduct of Monsanto's
and Dow AgroSciences' research programs, offering unique geneti c characteristics for specific
grower needs and may be protected by one or more of the followi ng U.S. patents found at the
following web page: www.monsantotechnology.com