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# MON 89034 × MIR162 × MON 95275 × MON 88017
- EPA Reg No: **524-671**
- 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/000524-00671-20260309.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:
524-671
Date of Issuance:
3/9/2026
Term of Issuance:
Unconditional
Name of Pesticide Product:
MON 89034 × MIR162 × MON
95275 × MON 88017
Name and Address of Registrant (include ZIP Code):
Bayer CropScience LLC
700 Chesterfield Pkwy 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
13:41:53 -04'00'
Page 2 of 25
EPA Reg. No. 524-671
OPP 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 from western corn rootworm (Diabrotica virgifera virgifera)], Bacillus
thuringiensis Cry3Bb1 protein, and the genetic material necessary for their production (vectors PV-
ZMIR245, 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.
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 creation of a non-Bacillus thuringiensis (Bt) lepidopteran-protected
hybrid corn refuge in conjunction with the planting of any acreage of MON 89034 × MIR162 ×
MON 95275 × MON 88017 corn.
x Requirements for Bayer to prepare and require MON 89034 × MIR162 × MON 95275 × MON
88017 corn users to sign grower agreements that impose binding contractual obligations on
growers to comply with the growing 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
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
Cry1A.105, Cry2Ab2, and/or Vip3Aa20 was detected, as well as to report on activity under the
Page 3 of 25
EPA Reg. No. 524-671
OPP Case No. 00659693
plan to EPA.
x Requirements for Bayer to investigate reports of unexpected CRW damage to MON 89034 ×
MIR162 × MON 95275 × MON 88017 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 corn.
x Requirements regarding mitigation and notification actions that Bayer would take in the event
that CRW resistance was detected.
x Requirements for Bayer to submit reports on resistance monitoring within the time frames
specified in this registration notice.
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 Bag Tag Requirements for MON 89034 × MIR162 × MON 95275 × MON 88017 corn: Seed bags
and/or bag tags for corn hybrids that contain plant-incorporated protectants produced in MON
89034 × MIR162 × MON 95275 × MON 88017 corn must display the registration number and
active ingredients, and stipulate that growers read the Bayer Stewardship Guide (or equivalent
guidance) prior to planting these hybrids. The refuge size requirement must be displayed on the
bag or bag tag in both text and graphic format.
a. Integrated Pest Management Stewardship Program (IPM)
1) Bayer must implement an IPM-based stewardship program for MON 89034 × MIR162 × MON 95275
× MON 88017 corn. This program must be designed to reduce selection pressure for 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 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 corn is not recommended for control of CRW except under limited circumstances and in
consultation with extension, crop consultants or other local experts. Grower education materials
should also state that SAIs should not be necessary for CRW control with pyramided CRW trait Bt
corn product(s). As part of the stewardship program, Bayer must promote the ABSTC/NCGA Best
Management Practices (BMPs) for CRW control. Implementation of the IPM strategy can include:
x Grower education initiatives or incentives;
x Outreach to extension and consultant groups.
Page 4 of 25
EPA Reg. No. 524-671
OPP Case No. 00659693
b. Refuge Requirements for MON 89034 × MIR162 × MON 95275 × MON 88017
The following information must be included on the product bag or bag tag as sold per respective region
and in the Grower Guide.
These refuge requirements do not apply to planting of inbred and hybrid corn seed productions,
breeding, and small-scale research trials on up to a total of 20,000 acres per county and up to a
combined United States (U.S.) total of 250,000 acres per plant-incorporated protectant (PIP) active
ingredient per registrant per year. Grower agreements (also known as stewardship agreements) will
specify that growers must adhere to the refuge requirements as described in the grower guide/product
use guide and/or in supplements to the grower guide/product use guide.
Common Refuge
A common refuge must be planted for both corn borers and corn rootworm and address the following:
x The common refuge must be planted with corn hybrids that do not contain PIP technologies for the
control of corn rootworm or corn borers.
x MON 89034 × MIR162 × MON 95275 × MON 88017 corn and the non-PIP refuge must 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.
x If the refuge is planted on rotated ground, then the MON 89034 × MIR162 × MON 95275 × MON
88017 corn field must also be planted on rotated ground.
x If the combined refuge is planted on continuous corn, the MON 89034 × MIR162 × MON 95275 ×
MON 88017 corn field may also be planted on either continuous or rotated land (option encouraged
where WCRW rotation resistant biotype may be present).
x Refuge options are based on the planting of MON 89034 × MIR162 × MON 95275 × MON 88017 corn
in cotton or non-cotton growing regions and the insect pressure present in those locations. The
refuge sizes for these regions are detailed in Table 1 below.
x In regions where corn rootworm is a significant pest, the common refuge must be planted as an in-
field or adjacent refuge using corn hybrids that do not contain PIP technologies for the control of corn
borers or corn rootworms.
x The common refuge can be planted as:
o A block within or adjacent (e.g., across the road) to the MON 89034 × MIR162 × MON 95275 ×
MON 88017 corn field;
o Perimeter strips (i.e., along the edges or headlands); or
o In-field strips.
Page 5 of 25
EPA Reg. No. 524-671
OPP Case No. 00659693
x When planting the refuge in strips across the field, refuges must be at least four (4) rows wide.
x The common refuge can be protected from lepidopteran damage by use of non-PIP insecticides if the
population of one or more target lepidopteran pests of MON 89034 × MIR162 × MON 95275 × MON
88017 if economic thresholds are exceeded in the refuge. 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. If
insecticides are applied to the refuge for control of CRW adults, the same treatment must also be
applied in the same timeframe to MON 89034 x MIR162 x MON 87411 corn fields. Economic
thresholds will be determined using methods recommended by local or regional professionals (e.g.,
Extension Service agents, crop consultants).
x In regions where corn rootworm is not a significant pest, the common refuge may be planted as an
in-field or adjacent refuge or as a separate block that is within ½ mile of the MON 89034 × MIR162 ×
MON 95275 × MON 88017 corn field. The common refuge must be planted with corn hybrids that do
not contain PIP technologies for the control of corn borers or corn rootworms must be used for the
refuge. Economic thresholds will be determined using methods recommended by local or regional
professionals (e.g., Extension Service agents, crop consultants).
Table 1: Refuge Requirements for MON 89034 × MIR162 × MON 95275 × MON 88017
Region Refuge
Size
In-field or
Adjacent
Refuge is
Allowed
Refuge Seperated
by up to ½ Mile is
Allowed
Cotton growing where CEW is a significant pest
and WCRW, NCRW and MCRW are not significant:
AR, NC, SC, GA, FL, TN (only the counties of
Carroll, Chester, Crockett, Dyer, Fayette, Franklin,
Gibson, Hardeman, Hardin, Haywood, Lake,
Lauderdale, Lincoln, Madison, Obion, Rutherford,
Shelby, and Tipton), AL, MS, LA, VA (only the
counties of Dinwiddie, Franklin City, Greensville,
Isle of Wight, Northampton, Southampton, Suffolk
City, Surrey, and Sussex)
20%
non-
PIP
corn
Yes Yes
Cotton growing where CEW is a significant pest
and WCRW, NCRW, and/or MCRW are significant:
TX (except the counties of Carson, Dallam,
Hansford, Hartley, Hutchinson, Lipscomb, Moore,
Ochiltree, Roberts, and Sherman), OK (only the
counties of Beckham, Caddo, Comanche, Custer,
Greer, Harmon, Jackson, Kay, Kiowa, Tillman, and
Washita), MO (only the counties of Dunkin, New
Madrid, Pemiscot, Scott, and Stoddard)
20%
non-
PIP
corn
Yes No
Page 6 of 25
EPA Reg. No. 524-671
OPP Case No. 00659693
Region Refuge
Size
In-field or
Adjacent
Refuge is
Allowed
Refuge Seperated
by up to ½ Mile is
Allowed
Cotton growing where CEW is not a significant
pest and WCRW, NCRW, and MCRW are not
significant: NM, AZ, CA, NV
5%
non-
PIP
corn
Yes Yes
Non-cotton growing where WCRW, NCRW and
MCRW are not significant: OR, WA, ID, MT, WY,
UT, VA (except the counties of Dinwiddie, Franklin
City, Greensville, Isle of Wight, Northampton,
Southampton,
Suffolk City, Surrey, and Sussex), WV, PA, MD,
DE,CT, RI, NJ, NY, ME, MA, NH, VT, HI, AK, TN
(except the counties of Carroll, Chester, Crockett,
Dyer, Fayette, Franklin, Gibson, Hardeman,
Hardin, Haywood, Lake, Lauderdale, Lincoln,
Madison, Obion, Rutherford, Shelby, and Tipton)
5%
non-
PIP
corn
Yes Yes
Non-cotton growing where WCRW, NCRW and/or
MCRW are significant: KS, NE, SD, ND, MN, IA, MO
(except the counties of Dunkin, New Madrid,
Pemiscot, Scott, and Stoddard), IL, WI, MI, IN, OH,
KY, CO, OK (except the counties of Beckham,
Caddo, Comanche, Custer, Greer, Harmon,
Jackson, Kay, Kiowa, Tillman, and Washita), TX
(only the counties of Carson, Dallam, Hansford,
Hartley, Hutchinson, Lipscomb, Moore, Ochiltree,
Roberts, and Sherman)
5%
non-
PIP
corn
Yes No
c. Grower Agreements for MON 89034 × MIR162 × MON 95275 × MON 88017
1) Persons purchasing MON 89034 × MIR162 × MON 95275 × MON 88017 corn must sign a grower
agreement. The term grower agreement refers to any grower purchase contract, license agreement,
or similar legal document.
2) The grower agreement and/or specific stewardship documents referenced in the grower agreement
must clearly set forth the terms of the current IRM program. By signing the grower agreement, a
grower must be contractually bound to comply with the requirements of the IRM program.
3) Bayer must 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 ×
MIR162 × MON 95275 × MON 88017
corn will affirm annually that they are contractually bound to
comply with the requirements of the IRM program.
Page 7 of 25
EPA Reg. No. 524-671
OPP Case No. 00659693
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, 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 corn
grower
agreements for a period of three (3) years from December 31st of the year in which the agreement
was signed.
6) Bayer shall make available to the Agency upon request records of the number of units of MON 89034
× MIR162 × MON 95275 × MON 88017
corn seed sold or shipped and not returned, and the number
of such units that were sold to persons who have signed grower agreements for the previous growing
season. Bayer is required to submit reports within three (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
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
corn users the importance of complying with the IRM program, as well as product performance
expectations and guidance to growers on actions to take when unexpected damage occurs. The
program shall include information encouraging MON 89034 × MIR162 × MON 95275 × MON 88017
corn users to pursue optional elements of the IRM program relating to refuge configuration and
proximity to MON 89034 × MIR162 × MON 95275 × MON 88017 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). Copies of the materials will be provided to EPA for
its records. The program shall involve at least one (1) written communication annually to each MON
89034 × MIR162 × MON 95275 × MON 88017 corn
user separate from the grower technical guide.
The communication shall inform the user of the current IRM requirements. 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.
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
Page 8 of 25
EPA Reg. No. 524-671
OPP Case No. 00659693
conducted either individually or as part of the industry working group, Agricultural Biotechnology
Stewardship Technical Committee (ABSTC). Bayer is required to submit reports within three (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
corn
are complying with the IRM program and that takes such actions as are reasonably needed to
assure that growers who have not complied with the program either do so in the future or lose their
access to Bayer’s Bt corn products. Bayer shall coordinate with other Bt corn registrants in improving
its compliance assurance program and integrate this registration into the current compliance
assurance program used for its other Bt corn plant-incorporated protectants. Other required features
of the program are described in paragraphs 5–22 of this section.
5) Bayer must maintain and publicize a phased compliance approach (i.e., a guidance document that
indicates how it will address instances of non-compliance with the terms of the IRM program and
general criteria for choosing among options for responding to any non-compliant growers after the
first year of non-compliance). While recognizing that for reasons of difference in business practices
there are needs for flexibility between different companies, Bayer must use a consistent set of
standards for responding to non-compliance. An individual grower found to be significantly out of
compliance two (2) years in a row would be denied access the next year to Bayer’s Bt corn products
for which the grower is required to plant a separate structured refuge. Similarly, seed dealers who
are not fulfilling their obligations to inform/educate growers of their IRM obligations will lose their
opportunity to sell Bt corn.
6) The IRM compliance assurance program shall include an annual survey, conducted by an independent
third party of a statistically representative sample of growers of MON 89034 × MIR162 × MON 95275
× MON 88017 corn. 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 if Bayer can demonstrate that the industry-wide adoption of integrated refuge
products (i.e., refuge seed blends) is equal to or greater than 70% of Bt corn acres in the Corn Belt. If
industry-wide adoption of integrated refuge products (i.e., refuge seed blends) falls below 70% of Bt
corn acres in the Corn Belt, an anonymous grower survey shall also be conducted in this region
during the next growing season using a statistically representative sample of growers who plant 200
or more acres of corn, and grower surveys shall be continued every odd-numbered year until the
industry-wide adoption of integrated refuge products (i.e., refuge seed blends) is again equal to or
greater than 70% of Bt corn acres in this region. Bayer may collaborate with other registrants of Bt
corn (for example, through the industry working group the ABSTC) to compile the integrated refuge
adoption data and to conduct the surveys.
Alternatively, if Bayer is not a participant of an industry working group (e.g., the ABSTC) and Bayer’s
Page 9 of 25
EPA Reg. No. 524-671
OPP Case No. 00659693
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 the registrant, the grower, or anyone else
with a direct interest in IRM compliance for Bt corn.
7) The survey shall be designed to provide an understanding of any difficulties growers encounter in
implementing IRM requirements. An analysis of survey results must include the reasons, extent, and
potential biological significance of any implementation deviations.
8) The survey shall be designed to obtain grower feedback on the usefulness of specific educational
tools and initiatives.
9) In years in which the survey is conducted, Bayer shall provide a final written summary of the results
of the 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 corn growers to
perform assessments of compliance with IRM requirements. There is no minimum corn acreage size
for this program. Therefore, growers will be selected for this program from across all farm sizes. In
the event that any of these visits result in the identification of a grower who is not in compliance with
the IRM program, Bayer shall take appropriate action, consistent with its phased compliance
approach, to promote compliance.
12) Bayer shall carry out a program for investigating legitimate tips and complaints that MON 89034 ×
MIR162 × MON 95275 × MON 88017 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 corn for planting, was
specifically identified as not being in compliance during the previous year, Bayer shall visit with the
grower and evaluate whether the grower is in compliance with the IRM program for the current year.
Page 10 of 25
EPA Reg. No. 524-671
OPP Case No. 00659693
14) Annually by January 31st each year, Bayer shall provide a report to EPA summarizing the MON 89034
× MIR162 × MON 95275 × MON 88017 compliance assurance program activities and the results for
the prior year and the plans for the MON 89034 × MIR162 × MON 95275 × MON 88017 compliance
assurance program during the current year. Within one (1) month of submitting this report to EPA,
the registrant shall meet with EPA to discuss its findings. The report will include information
regarding grower interactions (including, but not limited to, on-farm visits, verified tips and
complaints, grower meetings and letters), the extent of non-compliance, corrective measures to
address the non- compliance, and any follow-up actions taken. The report must inform EPA of the
number of growers deemed ineligible to purchase Bt corn seed on the basis of continued non-
compliance with the insect resistance management refuge requirements. Bayer may elect to
coordinate information with other registrants and report collectively the results of compliance
assurance programs.
15) Bayer and the seed corn dealers for Bayer must allow a review of the compliance records by EPA or
by a State pesticide regulatory agency if the State agency can demonstrate that confidential business
information, including the names, personal information, and grower license numbers of the growers,
will be protected.
16) Bayer shall revise and expand its existing compliance assurance program to include the following
elements. The registrant may coordinate with other registrants in designing and implementing its
Compliance Assurance Program.
17) Bayer will enhance the refuge education program throughout the seed delivery channel 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 Corn seed sold and delivered. The refuge size requirement must be included on all
PIP corn seed bags or bag tags. The PIP product label accepted by EPA must include how this
information will be conveyed to growers via text and graphics.
18) Bayer will focus the majority of on-farm assessments on regions with the greatest 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 is used.
19) Bayer will use its available MON 89034 × MIR162 × MON 95275 × MON 88017 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
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purchased MON 89034 × MIR162 × MON 95275 × MON 88017 corn products 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 crn 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 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
1) EPA is imposing the following conditions for the Cry1A.105, Cry2Ab2, and Vip3Aa20 toxins expressed
in MON 89034 × MIR162 × MON 95275 × MON 88017:
Bayer will monitor for resistance to expressed in Cry1A.105, Cry2Ab2, and Vip3Aa20 toxins MON 89034
× MIR162 × MON 95275 × MON 88017. 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
remedial 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
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(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 and/or changes in resistance allele frequency in response to the
use MON 89034 × MIR162 × MON 95275 × MON 88017 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. 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. EPA shall be consulted prior to
the implementation of such modifications.
Bayer will report to EPA, on or before August 31st of each year, the results of the population sampling
and bioassay monitoring program.
Any incidence of unusually low sensitivity to the Cry1A.105, 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 corn 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
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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
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 seed used had the proper percentage of corn expressing Bt protein;
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
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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 corn 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 corn
fields in the affected region to control the target pest during the immediate growing season.
x Destroy MON 89034 × MIR162 × MON 95275 × MON 88017 corn crop residues in the affected
region within one (1) month after harvest with a technique appropriate for local production
practices to minimize the possibility of resistant insects over-wintering and contributing to the
next season's target pest population.
Additionally, if possible, and prior to the application of alternative control measures or destruction
of crop residues, Bayer will collect samples of the insect population in the affected fields for
laboratory rearing and testing. Such rearing and testing shall be conducted as expeditiously as
practical.
Confirmed Resistance (ECB and SWCB)
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 (ECB and SWCB)
When field resistance is confirmed for ECB or SWCB (as defined above), the following steps will be taken
by Bayer:
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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
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, that follows EPA approved methods defined in the
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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 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
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
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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:
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) 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 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 × MIR162 × MON 95275 × MON
88017 corn fields meeting the criteria in part 1) above, Bayer must take the following actions:
a. Collect at least 250 (ideally 500 or more) CRW adult individuals from the damaged site
within the field in question. Collections may be extended to the whole field, if necessary
to obtain sufficient CRW adult individuals. Collected populations must be subjected to
the steps described for "investigation of populations of concern" in section e(2)(b)(3)(c)
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) 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 in fields with unexpected damage in previous years should be
discouraged. Recommended management options include, but are not limited to, the
following:
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o Primary option: 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.
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
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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. Acceptable
assays must be able to function as diagnostic tools capable of distinguishing resistant
populations from susceptible ones. Unless previously approved, Bayer must consult with EPA
on their bioassay prior to its use.
2) A CRW population will be considered by EPA to be resistant to a CRW PIP toxin if the
following criteria are met and additional collections and testing are not deemed to be
necessary (based on part 3 below
):
a. An initial performance inquiry investigation results in a finding of Unexpected Damage; and
b. Where green tissues are available and if plants are unusually stressed due to agronomic
and/or environmental factors, Bt protein levels in affected plants are found to be within
the documented range for that hybrid (if data are available); and
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:
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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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 population
1; and
ii. A lack of a statistically significant difference in the same measures of the field population
raised on Bt corn seedlings containing the single PIP and non-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 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, 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
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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 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
30 days if measures are triggered.
b. The mitigation action area (MAA) is defined as the growers’ farming operation up to a ½ mile
radius from the damaged site that produced the resistant population.
c. Within 30 days of informing EPA of the results of the bioassays, Bayer must notify state
extension agents and crop consultants who operate within the county 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
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be required by this term of registration, to follow suit;
v. For Bayer’s affected customer’s field(s), the mitigation goal is to control the resistant
CRW population. Within the MAA Bayer shall encourage the use of “Mitigation Practices”
including:
1. Primary option: Rotation to a non-host crop (e.g., soybean);
2. Secondary options:
a. Use of pyramided Bt corn products with different CRW PIP traits;
b. Only in the case that the resistance definition for one of the CRW traits in the MON
89034 × MIR162 × MON 95275 × MON 88017 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
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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 as a primary tool for CRW management in the
MAA, only when Bayer demonstrates that successful mitigation as described in part e above
has been achieved.
2) Based on further research to understand CRW resistance to Bt PIPs, EPA will consider
refinements to the resistance mitigation program. Such research may include characterizing the
genetics of resistance (e.g., number of genes, functional dominance, mechanism of resistance,
and cross-resistance) and the biology of resistant insects (e.g., fitness in the presence and
absence of the product), and other control tactics.
f. Annual Reporting Requirements for MON 89034 × MIR162 × MON 95275 × MON 88017
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 Monitoring Results (Cry1A.105, Cry2Ab2, and Vip3Aa20 only): Results of 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):
Page 24 of 25
EPA Reg. No. 524-671
OPP Case No. 00659693
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 (7511M)
Office of Pesticide Programs
Enclosure: MON 89034 × MIR162 × MON 95275 × MON 88017 Stamped Label
Digitally signed by
ALAN REYNOLDS
Date: 2026.03.09
13:42:45 -04'00'
Plant-Incorporated Protectant Label
MON 89034 × MIR162 × MON 95275 × MON 88017
(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
524-671
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
KEEP OUT OF REACH OF CHILDREN
Caution
EPA Registration No. 524-ATR
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 through conventional breeding
with other registered PIPs that are simila rly approved for use in combination, through
conventional breeding, with other registered PIPs.
MON 89034 × MIR162 × MON 95275 × MON 88017 protects corn crops from leaf, stalk,
and ear damage caused by lepidopteran corn pests listed on this la bel 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 × MIR162 × MON 95275 × MON 88017 corn,
an insect resistance management (IRM) plan must be implemented which includes planting
of a structured refuge.
INSECT RESISTANCE MANAGEMENT
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.
Several options for deployment of the refuge for MON 89034 × MIR162 × MON 95275 ×
MON 88017 are available to growers. These options are based on the planting of
MON 89034 × MIR162 × MON 95275 × MON 88017 in cotton or non-cotton growing
regions and the insect pressure present in those locations. The refuge sizes for these regions
are either 5% (i.e. 5 acres of non-PIP corn for every 95 acres MON 89034 × MIR162 ×
MON 95275 × MON 88017 corn planted) or 20 % (20 acres of non-PIP corn for every 80
acres of MON 89034 × MIR162 × MON 95275 × MON 88017 corn planted), and are
presented in the table below:
Region Refuge size
In-field or
adjacent
refuge
Refuge
separated
by up to ½
mile
Cotton growing states where CEW is a
significant pest a nd WCRW, NCRW and
MCRW are not significant: AR, NC, SC,
GA, FL, TN (only the counties of Carroll,
Chester, Crockett, Dyer, Fayette, Franklin,
Gibson, Hardeman, Hardin, Haywood,
Lake, Lauderdale, Lincoln, Madison,
Obion, Rutherford, Shelby, and Tipton),
AL, MS, LA, and VA (only the counties of
Dinwiddie, Franklin City, Greensville, Isle
of Wight, Northampton, Southampton,
Suffolk City, Surrey, and Sussex)
20% non-PIP
corn Yes Yes
Cotton growing states where CEW is a
significant pest and WCRW, NCRW
and/or MCRW are significant: TX (except
the counties of Carson, Dallam, Hansford,
Hartley, Hutchinson, Lipscomb, Moore,
Ochiltree
Roberts, and Sherman), OK (only the
counties of Beckha m, Caddo, Comanche,
Custer, Greer, Harmon, Jackson, Kay,
Kiowa, Tillman, and Washita), and MO
20% non-PIP
corn Yes No
(only the counties of Dunklin, New
Madrid, Pemiscot, Scott, and Stoddard)
Cotton growing states where CEW is not a
significant pest a nd WCRW, NCRW and
MCRW are not significant: NM, AZ, CA,
NV
5% non-PIP
corn Yes Yes
Non-cotton growing states where WCRW,
NCRW and MCRW ar e not significant:
OR, WA, ID, MT, WY, UT, VA (except
the counties of Dinwiddie, Franklin City,
Greensville, Isle of Wight, Northampton,
Southampton, Suffolk City, Surrey, and
Sussex) , WV, PA, MD, DE, CT, RI, NJ,
NY, ME, MA, NH, VT, HI, AK and TN
(except the counties of Carroll, Chester,
Crockett, Dyer, Fayette, Franklin, Gibson,
Hardeman, Hardin, Haywood, Lake,
Lauderdale, Lincoln, Madison, Obion,
Rutherford, Shelby, and Tipton)
5% non-PIP
corn Yes Yes
Non-cotton growing states where WCRW,
NCRW and/or MCRW are significant: KS,
NE, SD, ND, MN, IA, MO (except the
counties of Dunklin, New Madrid,
Pemiscot, Scott, and Stoddard), IL, WI,
MI, IN, OH, KY, CO, OK (except the
counties of Beckha m, Caddo, Comanche,
Custer, Greer, Harmon, Jackson, Kay,
Kiowa, Tillman, and Washita), and TX
(only the counties of Carson, Dallam,
Hansford, Hartley, Hutchinson, Lipscomb,
Moore, Ochiltree, Roberts, and Sherman)
5% non-PIP
corn Yes No
If corn rootworms (CRW) are si gnificant within a region, the structured refuge must be
planted as an in-field or adjacent refuge using corn hybrids that do not contain PIP
technologies for the control of corn borers or CRW. The structured refuge can be planted
as a block within or adjacent (e.g., acro ss the road) to the MON 89034 × MIR162 ×
MON 95275 × MON 88017 field, perimeter strips (i.e., strips around the field), or in-field
strips. If perimeter or in-field strips ar e implemented, the strips must be at least 4
consecutive rows wide. The refuge can be pr otected from lepidopteran damage by use of
non-B.t. insecticides if the population of one or more target lepidopteran pests of
MON 89034 × MIR162 × MON 95275 × MON 88017 in the refuge exceeds economic
threshold. In addition, the re fuge can be protected from CRW damage by an appropriate
seed treatment or soil insecticide; however , insecticides labeled for adult CRW control
should be avoided in the refuge during the period of CRW adult emergence . Economic
thresholds will be determined using methods recommended by local or regional
professionals (e.g., Extension Service agents , crop consultants). A schematic of one
common refuge deployment option is shown below:
Structured Refuge
If CRW are not significant within a region, the structured refuge may be planted as an in-
field or adjacent refuge, or as a separate block that is within ½ mile of the MON 89034 ×
MIR162 × MON 95275 × MON 88017 field. The struct ured refuge must be planted with
corn hybrids that do not contain PIP technologies for the control of corn borers or CRW.
Economic thresholds will be determined using methods recommended by local or regional
professionals (e.g., Extension Service agents, crop consultants). A schematic of one refuge
option with the refuge planted within a ½ mile of the MON 89034 × MIR162 ×
MON 95275 × MON 88017 field is shown below:
Separated Structured Refuge
MON 89034 ×
MIR162 ×
MON 95275 ×
MON 88017
Refuge
Non-PIP corn
MON 89034 ×
MIR162 ×
MON 95275 ×
MON 88017
ч ½ mile
Refuge
Non-PIP corn
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 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