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# MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend
- EPA Reg No: **524-670**
- Registrant: BAYER CROPSCIENCE, LLC
- Signal word: Caution
- Active ingredients: Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary (vector ZMIR39) for its production in corn (0.13%); Bacillus thuringiensis Cry1A.105 protein and genetic material necessary (vector PV-ZMIR245) for its production in corn (0.056%); Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary (vector PV-ZMIR245) for its production in corn (0.055%); Bacillus thuringiensis Vpb4Da2 protein and the genetic material necessary for its production in corn event MON 95275 (OECD Unique Identifier MON-95275-7) (0.0048%); Brevibacillus laterosporus Mpp75Aa1.1 protein and the genetic material necessary for its production in corn event MON 95275 (OECD Unique Identifier MON-95275-7) (0.025%); DvSnf7.1 RNA in corn event MON 95275 (OECD unique identifier MON-95275-7) (4.2e-05%); Bacillus thuringiensis Vip3Aa20 protein encoded by vector pNOV1300 in event MIR162 corn (SYN-IR162-4), % dw (0.15%)
- Label accepted: 2026-03-09
- Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000524-00670-20260309.pdf
---
U.S. ENVIRONMENTAL PROTECTION AGENCY
Office of Pesticide Programs
Biopesticides and Pollution Prevention Division (7511M)
1200 Pennsylvania Ave., N.W.
Washington, D.C. 20460
NOTICE OF PESTICIDE:
܈Registration
܆Reregistration
(under FIFRA, as amended)
EPA Reg. Number: Date of Issuance:
524-670 3/9/2026
Term of Issuance:
Unconditional
Name of Pesticide Product:
MON 89034 x MIR162 x MON 95275
x MON 88017 Seed Blend
Name and Address of Registrant (include ZIP Code):
Bayer CropScience LLC
700 Chesterfield Parkway West
Chesterfield, MO 63017
Note: Changes in labeling differing in substance from those accepted in connection with this registration must be submitted to and ac cepted by the
Biopesticides and Pollution Prevention Division prior to use of the label in commerce. In any correspondence regarding 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:
1. 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.
Signature of Approving Official:
Alan Reynolds, Product Manager 94
Emerging Technologies Branch
Biopesticides and Pollution Prevention Division (7511M)
Office of Pesticide Programs
Date:
3/9/2026
EPA Form 8570-6
Digitally signed by
ALAN REYNOLDS
Date: 2026.03.09
14:58:29 -04'00'
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EPA Reg. No. 524-670
OPP Action Case No. 00659693
2. The subject registration is limited to Bacillus thuringiensis Cry1A.105 and Cry2Ab2 proteins, Bacillus
thuringiensis Vip3Aa20 protein, Brevibacillus laterosporus Mpp75Aa1.1 protein, Bacillus thuringiensis
Vpb4Da2 protein, DvSnf7.1 dsRNA [double-stranded RNA transcript comprising a DvSnf7 inverted
repeat sequence derived western corn rootworm (Diabrotica virgifera virgifera)], Bacillus
thuringiensis Cry3Bb1 protein, and the genetic material necessary for their production (vectors PV-
ZMIR39 pNOV1300, PV-ZMIR525664, and PV-ZMIR39) in MON 89034 × MIR162 × MON 95275 × MON
88017 (OECD Unique Identifier: MON-89Ø34-3 × SYN-IR162-4 × MON-95275-7 × MON 88Ø17-3) for
use in field corn, and 5% non-Bt seed that when planted creates an interspersed refuge within the
field.
3. The subject registration 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.
4. Bayer CropScience LLC (Bayer) must develop and submit a resistance monitoring plan for
Mpp75Aa1.1 and Vpb4Da2. This plan must include a resistance detection assay that meets EPA's
criteria (see Section 5)(e)(b) below) and baseline susceptibility data. This plan must be submitted
within six (6) months of registration.
5. Bayer must commit to do the following Insect Resistance Management (IRM) Program, consisting of
the following elements:
x Requirements for Bayer to implement an IPM-based stewardship program designed to reduce
selection pressure for corn rootworm (CRW) resistance.
x Requirements relating to a refuge assurance program for ensuring the correct refuge blend
percentage.
x 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 MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend.
x Requirements for Bayer to prepare and require MON 89034 × MIR162 × MON 95275 × MON
88017 Seed Blend users to sign grower agreements that impose binding contractual obligations
on growers to comply with the refuge requirements.
x Requirements for Bayer to develop, implement, and report to EPA on programs to educate
growers about IRM.
x Requirements for Bayer to develop, implement, and report to EPA on programs to evaluate and
promote growers’ compliance with IRM requirements.
x Requirements for Bayer to develop, implement, and report to EPA on monitoring programs to
evaluate whether there are statistically significant and biologically relevant changes in
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EPA Reg. No. 524-670
OPP Action Case No. 00659693
susceptibility to the Cry1A.105, Cry2Ab2, and Vip3Aa20 proteins in the target insects.
x Requirements for Bayer to develop, and if triggered, to implement a remedial action plan that
would contain measures Bayer would take in the event that any field-relevant insect resistance
to Cry1A.105, Cry2Ab2, and Vip3Aa20 was detected, as well as to report on activity under the
plan to EPA.
x Requirements for Bayer to investigate reports of unexpected CRW damage to MON 89034 ×
MIR162 × MON 95275 × MON 88017 Seed Blend from growers (“performance inquiries”) and
sample CRW to determine if the insects are resistant to Cry3Bb1, Mpp75Aa1.1/Vpb4Da2, and/or
DvSnf7.1.
x Requirements for Bayer to recommend CRW management options to growers in response to
cases of unexpected CRW damage to MON 89034 × MIR162 × MON 95275 × MON 88017 Seed
Blend.
x Requirements regarding mitigation and notification actions that Bayer would take in the event
that CRW resistance was detected.
x Requirements for Bayer to make available to the Agency upon request records of the number of
units of MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend 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, within three months of the request.
x Requirements for Bayer to submit reports on resistance monitoring within the time frames
specified in this registration notice.
x Bag Tag Requirements for MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend: Seed
bags and/or bag tags for corn hybrids that contain plant-incorporated protectants produced in
MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend must display the registration
number and active ingredients, and stipulate that growers read the Bayer Stewardship Guide (or
equivalent guidance) prior to planting these hybrids. The refuge size requirement must be
displayed on the bag or bag tag in both text and graphic format.
x Requirements for Bayer 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 (IPM)
1) Bayer must implement an IPM-based stewardship program for MON 89034 × MIR162 × MON 95275
× MON 88017 Seed Blend. This program must be designed to reduce selection pressure for corn
rootworm (CRW) resistance by encouraging growers to engage in a multi-year crop rotation strategy
involving the use of one or more of the following: a non-CRW host crop (e.g., soybean), pyramided Bt
corn Plant Incorporated Protectants (PIPs), other PIP corn products with different modes of action,
and/or non-Bt or non-CRW protected Bt corn. As part of the stewardship program, Bayer must
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EPA Reg. No. 524-670
OPP Action Case No. 00659693
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 × MIR162 ×
MON 95275 × MON 88017 Seed Blend is not recommended for control of CRW except under limited
circumstances and in consultation with extension, crop consultants or other local experts. Grower
education materials should also state that SAIs should not be necessary for CRW control with
pyramided CRW trait Bt corn product(s). As part of the stewardship program, Bayer must promote
the ABSTC/NCGA Best Management Practices (BMPs) for CRW control. Implementation of the IPM
strategy can include:
x Grower education initiatives or incentives;
x Outreach to extension and consultant groups.
b. Refuge requirements for Bt11 × MIR162 × MZIR098 × DP4114 Refuge 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 × MIR162 × MON 95275 × MON 88017 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, common 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 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 cotton-growing regions where corn earworm is a significant pest:
x A 20% refuge must be planted with corn hybrids that do not contain PIP technologies for the
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EPA Reg. No. 524-670
OPP Action Case No. 00659693
control of corn rootworms or corn borers.
x MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend and the 20% non-Bt refuge
should be sown on the same day, or with the shortest window possible between planting dates.
x External refuges may be planted as an in-field or adjacent (e.g., across the road) refuge or as a
separate block within 1/2 mile of the MON 89034 × MIR162 × MON 95275 × MON 88017 Seed
Blend field.
x In field refuge options include: blocks, perimeter strips (i.e., along the edges or headlands), or in-
field strips.
x When planting the refuge in strips across the field, refuges must be at least four (4) rows wide.
x 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.
x Cotton-growing areas include the following states: Alabama, Arkansas, Georgia, Florida, Louisiana,
North Carolina, Mississippi, South Carolina, Oklahoma (only the counties of Beckham, Caddo,
Comanche, Custer, Greer, Harmon, Jackson, Kay, Kiowa, Tillman, 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 × MIR162 × MON 95275 × MON 88017 Seed Blend
1) Persons purchasing MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend must sign a
grower agreement. The term grower agreement refers to any grower purchase contract, license
agreement, or similar legal document.
2) The grower agreement and/or specific stewardship documents referenced in the grower agreement
must clearly set forth the terms of the current IRM program. By signing the grower agreement, a
grower must be contractually bound to comply with the requirements of the IRM program.
3) Bayer must continue to integrate this registration into the current system used for its other Bt corn
plant-incorporated protectants, which is reasonably likely to assure that persons purchasing MON
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EPA Reg. No. 524-670
OPP Action Case No. 00659693
89034 × MIR162 × MON 95275 × MON 88017 Seed Blend will affirm annually that they are
contractually bound to comply with the requirements of the IRM program.
4) If Bayer wishes to change any part of the grower agreement or any specific stewardship documents
referenced in the grower agreement that would affect either the content of the IRM program or the
legal enforceability of the provisions of the agreement relating to the IRM program, thirty (30) days
prior to implementing a proposed change, Bayer must submit to EPA the text of such changes to
ensure it is consistent with the terms and conditions of this registration.
5) Bayer shall maintain records of all MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend
grower agreements for a period of three (3) years from December 31st of the year in which the
agreement was signed.
6) Bayer shall make available to the Agency upon request records of the number of units of MON 89034
× MIR162 × MON 95275 × MON 88017 Seed Blend 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, within three (3) months of the Agency’s request.
7) Bayer must allow a review of the grower agreements and grower agreement records by EPA or by a
State pesticide regulatory agency if the State agency can demonstrate that confidential business
information, including names, personal information, and grower license numbers of the growers, will
be protected.
d. IRM Education and Compliance Monitoring Programs for MON 89034 × MIR162 × MON 95275 ×
MON 88017 Seed Blend
1) Bayer must implement and enhance (as set forth in paragraph 17 of this section) a comprehensive,
ongoing IRM education program designed to convey to MON 89034 × MIR162 × MON 95275 × MON
88017 Seed Blend 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 × MIR162 × MON
95275 × MON 88017 Seed Blend users to pursue optional elements of the IRM program relating to
refuge configuration and proximity to MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend
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 (1) written communication annually to each MON 89034 × MIR162 × MON 95275
× MON 88017 Seed Blend 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. Bayer shall coordinate its education programs with educational
efforts of other registrants and organizations, such as the National Corn Growers Association and
state extension programs.
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EPA Reg. No. 524-670
OPP Action Case No. 00659693
2) Bayer shall revise, and expand as necessary, its education program to take into account the
information collected through the compliance survey, required under paragraphs 6–9 of this
section, and from other sources. The changes shall address aspects of grower compliance that are
not sufficiently high.
3) Upon EPA request, Bayer shall provide copies of grower education materials and information on
grower education activities including any substantive changes to these materials and activities
conducted either individually or as part of a report from the industry working group, Agricultural
Biotechnology Stewardship Technical Committee (ABSTC). Bayer is required to submit reports within
three (3) months of the Agency’s request. The required features of the compliance assurance
program are described in paragraphs 4–22 of this section.
4) Bayer must implement and improve an ongoing IRM compliance assurance program designed to
evaluate the extent to which growers purchasing MON 89034 × MIR162 × MON 95275 × MON 88017
Seed Blend 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 Bayer’s Bt corn
products. Bayer shall coordinate with other Bt corn registrants in improving its compliance assurance
program and integrate this registration into the current compliance assurance program used for its
other Bt corn plant-incorporated protectants. Other required features of the program are described
in paragraphs 5–22 of this section.
5) Bayer must maintain and publicize a phased compliance approach (i.e., a guidance document that
indicates how it will address instances of non-compliance with the terms of the IRM program and
general criteria for choosing among options for responding to any non-compliant growers after the
first year of non- compliance). While recognizing that for reasons of difference in business practices
there are needs for flexibility between different companies, Bayer must use a consistent set of
standards for responding to non-compliance. An individual grower found to be significantly out of
compliance two (2) years in a row would be denied access to Bayer’s Bt corn products the next year.
Similarly, seed dealers who are not fulfilling their obligations to inform/educate growers of their IRM
obligations will lose their opportunity to sell Bt corn.
6) The IRM compliance assurance program shall include an annual survey, conducted by an
independent third party, of a statistically representative sample of growers of MON 89034 × MIR162
× MON 95275 × MON 88017 Seed Blend. The survey shall be conducted in odd-numbered years
beginning in 2027 and shall include growers who plant 100 or more acres of corn in the Southern
U.S. corn-cotton areas. Bayer may collaborate with other registrants of Bt corn [for example, through
the industry working group the Agricultural Biotechnology Stewardship Technical Committee
(ABSTC)] to conduct the survey.
In the U.S. Corn Belt, no anonymous grower survey is required for MON 89034 × MIR162 × MON
95275 × MON 88017 Seed Blend if Bayer can demonstrate that the industry-wide adoption of
integrated refuge products (i.e., refuge seed blends) is equal to or greater than 70% of Bt corn acres
Page 8 of 25
EPA Reg. No. 524-670
OPP Action Case No. 00659693
in the Corn Belt. If industrywide adoption of integrated refuge products (i.e., refuge seed blends)
falls below 70% of Bt corn acres in the Corn Belt, an anonymous grower survey shall also be
conducted in this region during the next growing season using a statistically representative sample
of growers who plant 200 or more acres of corn, and grower surveys shall be continued every odd-
numbered year until the industry-wide adoption of integrated refuge products (i.e., refuge seed
blends) is again equal to or greater than 70% of Bt corn acres in this region. Bayer may collaborate
with other registrants of Bt corn (for example, through the industry working group the ABSTC) to
compile the integrated refuge adoption data and to conduct the surveys.
Alternatively, if Bayer is not a participant of an industry working group (e.g., the ABSTC) and Bayer’s
sales of integrated refuge products are equal to or greater than 70% of the Bayer’s total Bt corn sales
in the prior year, then no anonymous grower survey is required in the U.S. Corn Belt. If the Bayer’s
sales of integrated refuge products fall below 70% of the Bayer’s total Bt corn sales, an anonymous
grower survey shall also be conducted in this region during the next growing season using a
statistically representative sample of growers who plant 200 or more acres of corn, and grower
surveys shall be continued every odd-numbered year until sales of integrated refuge products (i.e.,
refuge seed blends) are again equal to or greater than 70% of Bayer’s total Bt corn sales in this region.
x A third party is classified as a party other than Bayer, the grower, or anyone else with a
direct interest in IRM compliance for Bt corn.
7) The survey shall be designed to provide an understanding of any difficulties growers encounter in
implementing IRM requirements. An analysis of survey results must include the reasons, extent, and
potential biological significance of any implementation deviations.
8) The survey shall be designed to obtain grower feedback on the usefulness of specific educational
tools and initiatives.
9) In years in which the survey is conducted, Bayer shall provide a final written summary of the results
of the prior year’s survey (together with a description of the regions, the methodology used, and the
supporting data) to EPA on or before January 31st of each year. Bayer shall confer with other
registrants and EPA on the design and content of the survey prior to its implementation.
10) Bayer shall revise, and expand as necessary, its compliance assurance program to take into account
the information collected through the compliance survey, required under paragraphs 6–9 of this
section, and from other sources. The changes shall address aspects of grower compliance that are
not sufficiently high. Bayer must confer with EPA prior to adopting any changes.
11) Bayer shall conduct an annual on-farm assessment program. Bayer shall train its representatives who
make on-farm visits with MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend 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
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OPP Action Case No. 00659693
with the IRM program, Bayer shall take appropriate action, consistent with its phased compliance
approach, to promote compliance.
12) Bayer shall carry out a program for investigating legitimate tips and complaints that MON 89034 ×
MIR162 × MON 95275 × MON 88017 Seed Blend growers are not in compliance with the IRM
program. Whenever an investigation results in the identification of a grower who is not in
compliance with the IRM program, Bayer shall take appropriate action, consistent with its phased
compliance approach.
13) If a grower, who purchases MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend for
planting, was specifically identified as not being in compliance during the previous year, Bayer shall
visit with the grower and evaluate whether the grower is in compliance with the IRM program for
the current year.
14) Annually, by January 31st each year, Bayer must provide a report to EPA summarizing the MON
89034 × MIR162 × MON 95275 × MON 88017 Seed Blend compliance assurance program activities
and results for the prior year and plans for the MON 89034 × MIR162 × MON 95275 × MON 88017
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 seed on the basis of continued
non-compliance with the insect resistance management refuge requirements. Bayer may elect to
coordinate information with other registrants and report collectively the results of compliance
assurance programs.
15) Bayer and the seed corn dealers for Bayer must allow a review of the compliance records by EPA or
by a State pesticide regulatory agency if the State agency can demonstrate that confidential business
information, including the names, personal information, and grower license numbers of the growers,
will be protected.
16) Bayer shall revise and expand its existing compliance assurance program to include the following
elements. Bayer must prepare and submit a written description of its revised compliance assurance
program. Bayer may coordinate with other registrants in designing and implementing its compliance
assurance program.
17) Bayer will enhance the refuge education program throughout the seed delivery channel to:
x 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.
x Implement a “bag tag” that will be attached to all bags of MON 89034 × MIR162 × MON 95275 ×
MON 88017 Seed Blend seed sold and delivered. The purpose of this bag tag is to remind
growers that MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend products require a
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EPA Reg. No. 524-670
OPP Action Case No. 00659693
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) Bayer will focus the majority of on-farm assessments on regions with the greatest risk for resistance:
x Use Bt corn adoption, pest pressure information, and other available information to identify
regions where the risk of resistance is greatest.
x Focus approximately two-thirds of on-farm assessments on these regions, with the remaining
assessments conducted across other regions where MON 89034 × MIR162 × MON 95275 × MON
88017 Seed Blend is used.
19) Bayer will use its available MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend sales
records and other information to refine grower lists for on-farm assessments of their compliance
with refuge requirements to:
x Identify for potential on-farm assessment growers whose sales information indicates they have
purchased MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend product but may have
purchased little or no refuge seed from Bayer, licensees, or affiliated companies.
20) Bayer will contract with third parties to perform on-farm assessments of compliance with refuge
requirements:
x 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) Annually, Bayer will refine the on-farm assessment program for MON 89034 × MIR162 × MON
95275 × MON 88017 Seed Blend product to reflect the adoption rate and level of refuge compliance
for the product.
22) Bayer will follow up with growers who have been found significantly out of compliance under the
on- farm assessment program and are found to be back in compliance the following year:
x 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 (2) years by Bayer, a seed
supplier, or a third-party assessor, after completing the assessment process.
x Bayer will conduct follow-up checks on growers found to be significantly out of compliance
within three (3) years after they are found to be back in compliance.
x A grower found with a second incident of significant non-compliance with refuge requirements
for the Bt corn product within a five-year period will be denied access to Bayer’s Bt corn
products the next year. Similarly, seed dealers who are not fulfilling their obligations to
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OPP Action Case No. 00659693
inform/educate growers of their IRM obligations will lose their opportunity to sell Bt corn.
e. Insect Resistance Monitoring and Remedial Action Plans for MON 89034 × MIR162 × MON 95275 ×
MON 88017 Seed Blend
1) EPA is imposing the following conditions for the Cry1A.105, Cry2Ab2, and Vip3Aa20 toxins expressed
in MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend:
Bayer will monitor for resistance to Cry1A.105, Cry2Ab2, and Vip3Aa20 expressed in MON 89034 ×
MIR162 × MON 95275 × MON 88017 Seed Blend. The monitoring program European corn borer (Ostrinia
nubilalis; ECB) and southwestern corn borer (Diatraea grandiosella; SWCB) 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. Corn earworm (Helicoverpa zea;
CEW) will be monitored using sentinel plots and reports of unexpected injury to MON 89034 × MIR162 ×
MON 95275 × MON 88017 corn.
Focused Population Sampling
Bayer shall annually sample and bioassay populations of the key target pests: Ostrinia nubilalis
(European corn borer; ECB and Diatraea grandiosella (southwestern corn borer; SWCB). 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 ×
MIR162 × MON 95275 × MON 88017 Seed Blend and/or changes in resistance allele frequency in
response to the use MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend 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. 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 × MIR162 × MON 95275 × MON
88017 Seed Blend. EPA shall be consulted prior to the implementation of such modifications.
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Bayer will report to EPA, on or before August 31st of each year, the results of the population sampling
and bioassay monitoring program.
Any incidence of unusually low sensitivity to the Cry1A.105, Cry2Ab2, and Vip3Aa20 proteins in
bioassays shall be investigated as soon as possible to understand any field relevance of such a finding.
Such investigations shall proceed in a stepwise manner until the field relevance can be either confirmed
or refuted, and results of these shall be reported to EPA annually on or before August 31st. The
investigative steps will include the following:
1. 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.
2. 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 ×
MIR162 × MON 95275 × MON 88017 Seed Blend under field conditions. If progeny do not survive
to adulthood, any suspected resistance is not field relevant and no further action is required.
3. 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:
x Determining the nature of the resistance (i.e., recessive or dominant, and the level of functional
dominance);
x Estimating the resistance allele frequency in the original population;
x 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;
x Determining the geographic distribution of the resistance allele by analyzing field collections in
subsequent years from sites surrounding the site where the resistance allele(s) was originally
collected.
Should field-relevant resistance be confirmed, and the resistance appears to be increasing or spreading,
Bayer will consult with EPA to develop and implement a case-specific remedial action plan.
Investigation of Reports of Unexpected Levels of Damage by the Target Pests (ECB and SWCB)
Bayer will follow up on grower, extension specialist, or consultant reports of unexpected levels of
damage by the lepidopteran pests listed on the pesticide label. Bayer will instruct its customers to
contact them if such incidents occur and provide guidance to growers on seed blend product
performance expectations and actions to take when unexpected damage occurs. Bayer will investigate
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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 and SWCB), Bayer will implement the actions described below, based on the following
definitions of suspected resistance and confirmed resistance.
Suspected Resistance (ECB and SWCB)
EPA defines suspected resistance to mean field reports of unexpected levels of insect-feeding
damage for which:
x The corn in question has been confirmed to be lepidopteran-active Bt corn;
x The relevant plant tissues are expressing the expected level of Bt protein;
x 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
x That 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 ×
MIR162 × MON 95275 × MON 88017 Seed Blend in commercial production fields before responsive
measures are undertaken.
If resistance is suspected, Bayer will instruct growers to do the following:
x Use alternative control measures in MON 89034 × MIR162 × MON 95275 × MON 88017 Seed
Blend fields in the affected region to control the target pest during the immediate growing
season.
x Destroy MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend crop residues in the
affected region within one (1) month after harvest with a technique appropriate for local
production practices to minimize the possibility of resistant insects over-wintering and
contributing to the next season's target pest population.
Additionally, if possible, and prior to the application of alternative control measures or destruction of
crop residues, Bayer will collect samples of the insect population in the affected fields for laboratory
rearing and testing. Such rearing and testing shall be conducted as expeditiously as practical.
Confirmed Resistance (ECB and SWCB)
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EPA defines confirmed resistance to mean, in the case of field reports of unexpected levels of damage
from the key target pests, that all of the following criteria are met:
x 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.
x 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 ш 0.1 in the sampled
population.
x In standardized laboratory bioassays, the LC
50 exceeds the upper limit of the 95% confidence
interval of the LC50 for susceptible populations surveyed both in the original baselines developed
for this pest species and in previous years of field monitoring.
Response to Confirmed Resistance in a Key Target Pest as the Cause of Unexpected Levels of Damage
in the Field
When field resistance is confirmed for ECB or SWCB (as defined above), the following steps will be taken
by Bayer:
x EPA will receive notification within 30 days of resistance confirmation;
x Affected customers and extension agents will be notified about confirmed resistance within 30
days;
x 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;
x 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), alternate 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;
x 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;
x Bayer will develop a case-specific remedial action plan within 90 days according to the
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characteristics of the resistance event and local agronomic needs. Bayer will consult with
appropriate stakeholders in the development of the action plan, and the details of such a plan
shall be approved by EPA prior to implementation;
x Bayer will notify affected parties (e.g., growers, consultants, extension agents, seed distributors,
university cooperators, and state/federal authorities as appropriate) in the region of the
resistance situation and approved action plan; and
x 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.
Corn Earworm (CEW) Resistance Monitoring
x No annual CEW insect collections and subsequent bioassays are required for the Cry1A.105,
Cry2Ab2, and/or Vip3Aa20 proteins;
x A network of sentinel plots must be established in cotton growing states to monitor CEW
resistance in PIP corn products containing the Vip3Aa20 protein, including MON 89034 × MIR162
× MON 95275 × MON 88017 Seed Blend, that follows EPA approved methods defined in the
protocol for the establishment of sentinel plots, evaluation of CEW against the Vip3Aa20 protein
only, and calculation of a phenotypic a resistance ratio (MRID 52144201);
x Bayer must follow up on grower, extension specialist, or consultant reports of unexpected injury
(UXI) by CEW to MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend that meet the
criteria below. Bayer will instruct its customers to contact them if such incidents occur. Bayer
will investigate all legitimate reports submitted to the company or the company's
representatives.
o To investigate potential UXI to products containing Vip3Aa20, a minimum of a 100-ear sample
collected from the affected area of the field will be taken. UXI is confirmed if at least 10% of
individual ears sampled meet both of the following criteria: (1) one or more CEW larvae (ш 3rd
instar) or exit holes are present; and (2) there is at least 2 cm
2 of CEW feeding injury.
x If UXI triggers for CEW above are exceeded, Bayer must implement the mitigation actions below:
o Report the results of any investigations confirming the UXI and the affected county where
the report occurred in an annual resistance monitoring report to EPA;
o Inform affected customer(s) and state extension agents of the UXI within 30 days within 30
days of the UXI confirmation; and
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o Where in-season management tactics are possible, the recommended management options
include, but are not limited to the following:
ƒ Apply an appropriate foliar chemical insecticide (only if economically viable in corn);
ƒ If additional pest management is needed, additional control tactics as appropriate (e.g.,
additional foliar insecticide applications, tillage practices).
ƒ If in-season management tactics are not possible, the recommended management
options for the next growing seasons include, but are not limited to the following:
x Switching to a different Bt mode of action or planting non-Bt corn;
x Encourage timely planting to avoid primary risk window for primary pests;
x Encourage growers to monitor for adults and intensify field scouting for
injury in corn fields;
x Use appropriately timed foliar insecticide application based on field scouting
for insect injury;
x If additional pest management is needed, additional control tactics as
appropriate (e.g., additional foliar insecticide applications, tillage practices).
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 the following conditions for the
Cry3Bb1, Mpp75Aa1.1/Vpb4Da2, and DvSnf7.1 toxins
expressed in MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend:
a) Investigation of Reports of Unexpected Levels of Damage (UXD) by Corn Rootworm (CRW):
Performance Inquiries
1. Bayer is required to investigate "performance inquiries" (i.e., reports of unexpected CRW
damage to MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend) from growers.
Fields (defined as a tract separated by permanent boundaries such as fences, permanent
waterways, woodlands, crop lines 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 × MIR162 × MON 95275 × MON
88017 Seed Blend 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 × MIR162 × MON 95275 × MON
88017 Seed Blend fields meeting the criteria in part 1) above, Bayer must take the following
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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 × MIR162 × MON
95275 × MON 88017 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:
ƒ Rotation to non-host crop (e.g., soybean)
o Secondary options:
ƒ Use of pyramided Bt corn products one or more different CRW PIP trait(s);
ƒ Use of different CRW PIP traits (i.e., an alternative CRW-active PIP);
ƒ Use of non-Bt or non-CRW protected corn.
o Tertiary options:
ƒ If additional pest management need is determined beyond the secondary options
listed above, use of the same pyramided Bt corn product is acceptable if it is very
unlikely that both of the traits are affected (e.g., the affected field experienced
UXD to one of the traits in the product in the previous year, the NIS is less than
1.0, there has been no continuous use of the second trait in the product in the
affected field, and Bayer has not been informed of resistance to the second trait
in the county);
ƒ Additional corn rootworm control tools (e.g., soil applied insecticides,
chemigation) should be considered.
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d. If field(s) with UXD is/are planted to a non-host crop (e.g., soybean) the following year,
then the area will be considered “mitigated” (as discussed in section e(2)(b)(3)(d) below)
even if subsequent bioassay results show that the population was resistant. No further
action will be required by Bayer for the UXD case.
3. Bayer must submit an annual report to EPA detailing activities related to investigations of
unexpected damage (UXD). This report will include the information from the most recent and
previous corn growing seasons:
a. Information from the most recent season:
o The number of UXD reports investigated;
o Location (by county and state);
o CRW sampling (number and location of populations collected).
b. Information from the previous season:
o The final disposition of UXD fields from the previous season (i.e., the management
practices employed in response to UXD if the grower continues to be a customer;
o Results from bioassays conducted on CRW populations from UXD fields where the
primary management option, rotation to non-host crop, was not used.
c. Grower information, such as farm addresses or other personally identifiable information,
or other sensitive business/customer information must not be included in this report.
This report must be submitted by November 30th each year.
b) Investigation of Populations of Concern
1. Bayer must conduct investigations of all CRW populations collected as part of the
performance inquiry process in section e(2)(a) above. These investigations must include the
use of an EPA-approved bioassay to determine if sampled CRW populations are resistant to
any of the CRW PIP toxins in MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend.
Acceptable assays must be able to function as diagnostic tools capable of distinguishing
resistant populations from susceptible ones. Unless previously approved, Bayer must consult
with EPA on their bioassay prior to its use.
2. A CRW population will be considered by EPA to be resistant to a CRW PIP toxin if the
following criteria are met and additional collections and testing are not deemed to be
necessary (based on
part 3 below):
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OPP Action Case No. 00659693
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 population
1; and
ii. A lack of a statistically significant difference in the same measures of the field
population raised on Bt corn containing the single PIP and non-Bt corn plants.
Or (B): Sublethal seedling bioassay of insect collections from the UXD fields result in two
statistically relevant comparisons:
i. A statistically significant difference in measures of sublethal effects
(growth/development) for populations on Bt corn containing the single PIP
(normalized using non-Bt) seedlings between the field population and a relevant
susceptible control 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
1 If a resistant positive control population is not available or accessible, Bayer must consult with EPA prior to initiating bioassays
and work to develop an appropriate resistant positive control population.
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resistant positive control population;1 and
ii. Either a lack of a statistically significant difference in the same measures of the field
population exposed to diet containing the Bt protein (diagnostic concentration) and
diet not containing the Bt protein and/or lack of a statistically significant difference in
measures between the field population and a resistant positive control population, or
lack of a statistically significant concentration and/or lack of a statistically significant
difference in concentration response between the field and a resistant positive control
population.1
3. Mitigation, as detailed in section e(2)(c) below, is required for any CRW population that
meets EPA’s resistance criteria above for any of the CRW traits in MON 89034 × MIR162 ×
MON 95275 × MON 88017 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, Bayer and EPA will discuss and align on next steps before reaching any
resistance conclusion.
c. If CRW collections are not possible in the current year or subsequent year due to
successful management practices, then no further investigation is needed. The population
would be considered "mitigated" meaning, in this case, that the population is suppressed
or extirpated for the UXD field. However, EPA recommends that Bayer continue to be
vigilant in areas where CRW populations were successfully mitigated.
d. If a UXD field receives non-host crop (e.g., soybean) rotation the following year as
described in Section e(2)(a)(2) above, no additional mitigation is subsequently required.
c) Mitigation of CRW Populations Meeting EPA’s Resistance Criteria
1. For any CRW population found to be resistant to one or more of the CRW traits in MON 89034 ×
MIR162 × MON 95275 × MON 88017 Seed Blend under EPA’s criteria described in section e(2)(b)
above, Bayer must take the following steps:
a. Bayer must inform EPA of the results of the bioassays as soon as possible, but at least within
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thirty (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 thirty (30) days of informing EPA of the results of the bioassays, Bayer must notify
state extension agents and crop consultants who operate within the county resistance was
identified. Information shared must include identification of the county in which resistance
was detected and trait(s) affected.
d. Within the MAA, Bayer must do the following:
i. Prior to finalizing the grower’s seed order for the following season, inform the affected
grower and other registrants that hold registrations containing the compromised trait(s).
Bayer must also inform neighboring growers if those growers are customers of Bayer.
Information shared must include identification of the county in which resistance was
detected and trait(s) affected;
ii. Discontinue sales/planting of products containing the compromised trait(s) without
additional/alternative (i.e. non-compromised) CRW traits until resistance has been
demonstrated to have been mitigated. Other Bt registrants selling such products in the
MAA are encouraged, but cannot be required, to follow suit;
iii. Bayer must monitor the resistant population in the MAA, as long as grower remains a
customer of the company, until mitigation has been demonstrated as described in part e
below unless otherwise agreed with EPA;
iv. Require any pyramids sold by Bayer containing the compromised trait(s) be planted with
a 20% refuge until resistance has been demonstrated to have been mitigated. Other Bt
corn registrants selling such pyramided products in the MAA are encouraged, but cannot
be required by this term of registration, to follow suit;
v. For Bayer’s affected customer’s field(s), the mitigation goal is to control the resistant
CRW population. Within the MAA Bayer shall encourage the use of “Mitigation Practices”
including:
1. Primary option: Rotation to a non-host crop (e.g., soybean);
2. Secondary options:
a. Use of pyramided Bt corn products with different CRW PIP traits;
b. Only in the case that the resistance definition for one of the CRW traits in the MON
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89034 × MIR162 × MON 95275 × MON 88017 Seed Blend is not met, continued use
of the product with a 20% refuge;
c. Use of different CRW PIP traits (i.e., an alternative CRW- active PIP);
d. Use of non-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;
e. A resistant CRW population in the MAA will be considered mitigated if one of the following
criteria are 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 MON
89034 × MIR162 × MON 95275 × MON 88017 Seed Blend as a primary tool for CRW
management in the MAA, only when Bayer demonstrates that successful mitigation as
described in part e above has been achieved.
2. Based on further research to understand CRW resistance to Bt PIPs, EPA will consider refinements
to the resistance mitigation program. Such research may include characterizing the genetics of
resistance (e.g., number of genes, functional dominance, mechanism of resistance, and cross-
resistance) and the biology of resistant insects (e.g., fitness in the presence and absence of the product),
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and other control tactics.
f. Refuge Assurance Program for MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend
Bayer must implement a Blended Seed Refuge Assurance Program designed to ensure MON 89034 ×
MIR162 × MON 95275 × MON 88017 Seed Blend 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.
x Calibration records - Bayer will retain documentation for a specified period of time on the
equipment calibration including the procedure, when it was conducted and the results.
x Blend proportion records (weight and kernel based) – Bayer 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 × MIR162 × MON 95275 × MON 88017 Seed Blend product by seed lot.
All records must be maintained by the Bayer blending facility, third party contractors, and Bayer
licensees and must be available for the EPA review upon request.
Should Bayer or Bayer'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 thirty (30) days. This would constitute
information reportable under FIFRA section 6(a)(2).
g. Annual Reporting Requirements for MON 89034 × MIR162 × MON 95275 × MON 88017 Seed
Blend
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 of each year.
2) Insect Resistance Monitoring Results (Cry1A.105, Cry2Ab2, and Vip3Aa20 only): Results of
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OPP Action Case No. 00659693
monitoring and investigations of damage reports, on or before August 31st of each year.
3) Unexpected Damage Investigations (Cry3Bb1, Mpp75Aa1.1/Vpb4Da2, and DvSnf7.1 only): Activities
related to investigations of unexpected damage (UXD), including number and location of UXD cases,
insect sampling, bioassays, and final disposition of UXD fields from the most recent and previous corn
growing seasons, on or before November 30th of each year.
Should you wish to add/retain a reference to your company’s website on your label, then please be aware
that the website becomes labeling under FIFRA and is subject to review by the EPA. If the website is false or
misleading, the product will be considered to be misbranded and sale or distribution of the product is
unlawful under FIFRA section 12(a)(1)(E). 40 CFR § 156.10(a)(5) lists examples of statements the EPA may
consider false or misleading. In addition, regardless of whether a website is referenced on your product’s
label, claims made on the website may not substantially differ from those claims approved through the
registration process. Therefore, should the EPA find or if it is brought to our attention that a website
contains false or misleading statements or claims substantially differing from the EPA-approved registration,
the website will be referred to the EPA’s Office of Enforcement and Compliance Assurance.
Your release for shipment of this product constitutes acceptance of these terms. If these terms are not
complied with, this registration will be subject to cancellation in accordance with FIFRA section 6.
A stamped copy of the labeling is enclosed for your records. Please also note that the record for this
product currently contains the following acceptable Confidential Statement of Formula (CSF):
x Basic CSF dated May 15, 2025
If you have any questions, please contact Stephanie Kelly of my team by phone at (202) 566-0890 or via
email at kelly.stephanie@epa.gov.
Sincerely,
Alan Reynolds, Product Manager 94
Emerging Technologies Branch
Biopesticides and Pollution
Prevention Division
Office of Pesticide Programs
Enclosure: MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend Stamped Label
Digitally signed by
ALAN REYNOLDS
Date: 2026.03.09
14:59:23 -04'00'
Plant-Incorporated Protectant Label
MON 89034 × MIR162 × MON 95275 × MON 88017 Seed Blend
(OECD Unique Identifier: MON-89Ø34-3 × SYN-IR162-4 × MON-95275-7 × MON-
88Ø17-3)
Active Ingredients:
Bacillus thuringiensis Cry1A.105 protein and the geneti c material necessary for its
production (vector PV-ZMIR245) in corn event MON 89034 (OECD Unique Identifier
021‘  ” 
Bacillus thuringiensis Cry2Ab2 protein and the geneti c material necessary for its
production (vector PV-ZMIR245) in corn event MON 89304 (OECD Unique Identifier
021‘  ” 
Bacillus thuringiensis Vip3Aa20 insecticidal protein and the genetic material necessary for
its production (via elements of vector pNOV1300) in corn event MIR162 (OECD Unique
,GHQWLILHU 6<1,5  ” 
Brevibacillus laterosporus Mpp75Aa1.1 protein and the genetic material necessary for its
production (vector PV-ZMIR525664) in corn event MON 95275 (OECD Unique Identifier
021 ««««««««««««««««««««««««”
Bacillus thuringiensis Vpb4Da2 protein and the geneti c material necessary for its
production (vector PV-ZMIR525664) in corn event MON 95275 (OECD Unique Identifier
021 «««««««««««««««««««««««”
dsRNA transcript comprising a DvSnf7.1 in verted repeat sequence derived from
Diabrotica virgifera , and the genetic material nece ssary for its production (vector
PV-ZMIR525664) in corn event MON 95275 (OECD Unique Identifier MON-95275-7)
 ”
Bacillus thuringiensis Cry3Bb1 protein and the geneti c material necessary for its
production (vector PV-ZMIR39) in corn event MON 88017 (OECD Unique Identifier
021‘ «««««««««««««««««««««««««” 
Other Ingredients:
CP4 EPSPS protein (5-enolpyruvylshikimate- 3-phosphate synthase) and the genetic
material necessary for its production (vec tor PV-ZMIR39) in corn event MON 88017
2(&' 8QLTXH ,GHQWLILHU 021‘ ««««««««««««««”
03/09/2026
524-670
PMI protein (phosphomannose isomerase) and the genetic material necessary for its
production (via elements of vector pNOV 1300) in corn event MIR162 (OECD Unique
,GHQWLILHU6<1,5 «««««««««««««««««««««”

*Percentage (wt/wt) on a dry weight ba sis for whole plant (forage) of MON 89034 ×
MIR162 × MON 95275 × MON 88017 plants.
The MON 89034 × MIR162 × MON 95275 × MON 88017 seed with this refuge
configuration contains 95% MON 89034 × MIR162 × MON 95275 × MON 88017 mixed
with 5% non-PIP corn within a single lot of seed.
KEEP OUT OF REACH OF CHILDREN
Caution
EPA Registration No. 524-ATN
EPA Establishment No. 524-MO-002
Bayer CropScience LLC
700 Chesterfield Pkwy W
Chesterfield, MO 63017
U.S.A.
NET CONTENTS__________
DIRECTIONS FOR USE
It is a violation of Federal law to use this product in any manner inconsistent with its
labeling. Information regarding commercial production reflected here and in the terms and
conditions of this registration must be included in the Technology Use Guide.
This Plant-Incorporated Protectant (PIP ) may be combined or produced through
conventional breeding with other registered PIPs that are si milarly approved for use in
combination, through conventional breeding, with other registered PIPs.
MON 89034 × MIR162 × MON 95275 × MON 88017 seed blend protects corn crops from
leaf, stalk, and ear damage caused by lepidopter an 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 resista nce to MON 89034 × MIR162 × MON 95275 ×
MON 88017 seed blend, an insect resistanc e management (IRM) plan must be
implemented as defined in the registration terms and conditions.
INSECT RESISTANCE MANAGEMENT
Grower agreements will specify that growers mu st adhere to the refuge requirements that
will be described on the bag or ba g/tag for MON 89034 × MIR162 × MON 95275 ×
MON 88017 seed blend or other applicable product use documents.
Maize seed bags or bag tags for products containing MON 89034 × MIR162 × MON 95275
× MON 88017 seed blend must include the refuge size requirement in text and graphical
format.
These refuge requirements do not apply to planting of inbred/hybrid corn seed productions,
breeding, and small-scale research trials on up to a total of 20,000 acres per county and up
to a combined United States (U.S.) total of 250,000 acres per PIP active ingredient per
registrant per year.
Growers are instructed to read information on IRM on the bag and/or bag-tag.
The seed producer must ensure a minimum of 5% non-PIP refuge seed is included with
MON 89034 × MIR162 × MON 95275 × MON 88017 in each lot of seed corn. The refuge
seed in the seed mixture may not be treate d with seed-applied insecticides for corn
rootworm (CRW) control unless the MON 89034 × MIR162 × MON 95275 × MON 88017
seed in the seed mixture receives the same treatment.
The IRM/Grower Guide for MON 89034 × MIR162 × MON 95275 × MON 88017 seed
blend or comparable information presented on the product bag or bag-tag, must contain the
following information:
This product is a seed mixture c ontaining MON 89034 × MIR162 × MON 95275 ×
MON 88017 and a minimum of 5% non-PIP seed that when planted creates an interspersed
refuge within the field. There are no require ments for a separate structured refuge for
MON 89034 × MIR162 × MON 95275 × MON 88017 seed blend when planted in the U.S.
corn-growing region, including Alaska and Hawa ii, because the refuge seed is contained
within the bag/container.
The interspersed refuge can only be used by pl anting seed corn specifically generated by
qualified seed producers/conditione rs licensed by the registrant. Insecticidal treatments
labeled for adult CRW control are discouraged during the time of adult CRW emergence.
The seed mix refuge option for MON 89034 × MIR162 × MON 95275 × MON 88017
seed blend satisfies th e refuge requirements in all re gions other than in the cotton-
growing region where corn earworm is a significant pest as defined below.
Additional refuge requirements in the cotton-growing region where corn earworm is
a significant pest
In the cotton-growing region where corn earwor m is a significant pest , as defined below,
MON 89034 × MIR162 × MON 95275 × MON 88017 seed blend requires the planting of
an additional 20% structured refuge (i.e. 20 acres of non-PIP corn for every 80 acres of
MON 89034 × MIR162 × MON 95275 × MON 88017 seed blend planted).
The 20% refuge must be planted with corn hybrids that do not contain PIP technologies for
the control of corn rootworms or corn bor ers. The refuge and the MON 89034 × MIR162
× MON 95275 × MON 88017 seed blend should be sown on the same day, or with the
shortest window possible between planting dates to ensure that corn root development is
similar among varieties. The stru ctured refuge may be planted as an in-field or adjacent
(e.g., across the road) refuge or planted as a separate block that is within ½ mile of the
MON 89034 × MIR162 × MON 95275 × MON 88017 seed blend field. In-field refuge
options include blocks, perimeter strips (i.e., strips around the fi eld), or in-field strips. If
perimeter or in-field strips are implemented, the strips must be at least 4 consecutive rows
wide. The refuge can be protected from lepidopteran damage by use of non-Bt insecticides
if the population of one or more target Lepidopteran pests of MON 89034 × MIR162 ×
MON 95275 × MON 88017 seed blend in the ref uge 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 adul t emergence. Economic thresholds will be
determined using methods recommended by local or regional professionals (e.g., Extension
Service agents, crop consultants).
The cotton-growing region requiring the additi onal 20% refuge consists 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,
Lake, Lauderdale, Lincoln, Madison, Ob ion, 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).
Corn Insects Controlled or Suppressed
European corn borer (ECB) Ostrinia nubilalis
Southwestern corn borer (SWCB) Diatraea grandiosella
Southern cornstalk borer (SCSB) Diatraea crambidoides
Corn earworm (CEW) Helicoverpa zea
Fall armyworm (FAW) Spodoptera frugiperda
Stalk borer Papaipema nebris
Sugarcane borer (SCB) Diatraea saccharalis
Beet armyworm Spodoptera exigua
True armyworm Pseudelatia unipuncta
Black cutworm Agrotis ipsilon
Western bean cutworm (WBC) Striacosta albicosta
Lesser cornstalk borer Elasmopalpus lignosellus
Dingy Cutworm Feltia jaculifera
Western corn rootworm (WCRW) Diabrotica virgifera virgifera
Mexican corn rootworm (MCRW) Diabrotica virgifera zeae
Northern corn rootworm (NCRW) Diabrotica barberi
Sales of corn hybrids that c ontain Bayer’s PIPs must be accompanied by either a grower
guide or bag tag which includes informat ion on planting, production, and IRM and notes
that routine applications of insecticides to control these insects are usually unnecessary
when corn containing the PIPs are planted.
__________________________
MON 89034 × MIR162 × MON 95275 × MON 88017 seed blend is a product of Bayer’s research program
offering unique genetic characteristics for specific grower needs and may be protected by one or more of the
following U.S. patents that can be found at http://cs.bayerpatents.bayer.com