Files
crop-chem-docs/corpus/epa_ppls/7969-434.md
T

497 lines
21 KiB
Markdown
Raw Blame History

This file contains ambiguous Unicode characters
This file contains Unicode characters that might be confused with other characters. If you think that this is intentional, you can safely ignore this warning. Use the Escape button to reveal them.
# GMB151 PLANT-PARASITIC NEMATODE-PROTECTED SOYBEAN
- EPA Reg No: **7969-434**
- Registrant: BASF AGRICULTURAL SOLUTIONS US, LLC
- Signal word: Caution
- Active ingredients: Bacillus thuringiensis Cry14Ab-1 Crystal Protein as Expressed in Soy bean (0.016622%)
- Label accepted: 2026-08-17
- Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/007969-00434-20260817.pdf
---
August 17, 2026
Andrew Olson. Ph.D.
U.S. Regulatory Manager
BASF Agricultural Solutions US LLC
2 T.W. Alexander Drive
Research Triangle Park, NC 27713
Subject: Non-PRIA (Pesticide Registration Improvement Act) Amendment – Removal
of the Registration Expiration Date, Updates to the Nematode Resistance
Management Terms of Registration, and Addition of IPM Language to Product
Label.
Product Name: GMB151 Soybean
EPA Registration Number: 7969-434
EPA Receipt Date: July 28, 2026
OPP Action Case Number: 00713372
Dear Dr. Olson:
The amendments referenced above and described below, submitted in connection with
registration under Section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), are acceptable. The updated terms and conditions are as follows:
1. Submit/cite all data required for registration of your product under FIFRA section 3(c)(5)
when the Agency requires all registrants of similar products to submit such data.
2. The subject registration will be limited to Bacillus thuringiensis Cry14Ab-1 (vector pSZ8832)
and the genetic material necessary for its production in GMB151 Soybean (OECD Unique
Identifier: BCS-GM151-6).
3. GMB151 Soybean 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
soybean varieties with combined pesticidal traits.
4. BASF must submit the following data and/or information within the timeframe specified:
a. Grower stewardship materials with respect to Heterodera glycines, soybean cyst
nematodes, including educational materials and the technology use guide for the
Page 2 of 9
EPA Registration No. 7969-434
Action Case No. 00713372
product. These materials must be submitted within 90 days of the first commercial
plantings of GMB151 Soybean.
b. Baseline susceptibility data, sampling methods, and on-plant greenhouse bioassay
methodology for detecting resistant populations. These methods and accompanying
data must be submitted within one year of commercial plantings of GMB151
Soybean.
5. BASF must combine GMB151 Soybean (Cry14Ab-1) with soybean lines natively resistant to
soybean cyst nematode, such as PI 88788.
6. Resistance Management Program Elements. The required resistance management plan for
GMB151 soybeans must have the following components:
a. BASF must implement an Integrated Pest Management (IPM)-based stewardship
program for GMB151 Soybean;
b. Requirements for BASF to prepare and require GMB151 Soybean users to sign
“grower agreements” which impose binding contractual obligations on the grower
to comply with the RM requirements including best management practices for
soybean cyst nematodes;
c. Requirements for BASF to develop, implement, and report to EPA on programs to
educate growers about resistance management practices as well as tools to evaluate
growers' adoption of the measures recommended under the resistance
management program;
d. Requirements for BASF to develop, implement, and report to EPA on a resistance
monitoring program for soybean cyst nematodes using sentinel plots and
investigations of grower reports of unexpected damage;
e. Requirements for BASF to develop, implement, and report to EPA on a resistance
confirmation bioassay to determine whether there are statistically significant and
biologically relevant changes in susceptibility to Cry14Ab-1 protein in soybean cyst
nematodes;
f. Requirements for BASF to develop, and if triggered, to implement a "remedial action
plan" which would contain measures BASF would take in the event that any
resistance was detected as well as to report on activity under the plan to EPA;
g. Requirements for annual reports on or before the time frames specified in the
Annual Reports section below.
Page 3 of 9
EPA Registration No. 7969-434
Action Case No. 00713372
7. Resistance Management Plan Requirements
a. Integrated pest management (IPM) stewardship program
BASF must implement a best management practice (BMP)-based stewardship
program for GMB151 Soybean. This program will be designed to reduce selection
pressure for soybean cyst nematode resistance and prolong trait durability.
Implementation of the IPM strategy can include grower education initiatives and
outreach to extension and consultant groups. Key components of the stewardship
program include:
x Non-host crop rotation after use of GMB151 Soybean;
x Eliminate non-crop host plants during non-host crop rotation;
x Monitoring for unexpected injury;
x Sanitation and dispersal limitation measures.
BASF must submit an annual report to the EPA documenting activities conducted
under the IPM stewardship program. The report must include:
x A third-party anonymous survey of grower practices an assessment of
grower practices;
x The level of IPM/BMP adoption by commercial growers of GMB151 Soybean
growers in different regions of the country; and
x A discussion of the potential impact of non-adoption of IPM/BMP measures.
This report is due January 31
st, the following year of each growing season, beginning
the first growing season of GMB151 Soybean commercial use.
b. Grower Agreements
1) Persons purchasing GMB151 Soybean 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 resistance
management program. By signing the grower agreement, a grower must be
contractually bound to comply with the requirements of the resistance
management program.
3) BASF must implement an approved system which is reasonably likely to assure
that persons purchasing GMB151 Soybean will affirm annually that they are
Page 4 of 9
EPA Registration No. 7969-434
Action Case No. 00713372
contractually bound to comply with the requirements of the resistance
management program.
4) BASF must use a grower agreement for GMB151 Soybean. If BASF wishes to
change any part of the grower agreement that would affect either the content of
the resistance management program or the legal enforceability of the provisions
of the agreement relating to the resistance management program, thirty days
prior to implementing a proposed change, BASF must submit to EPA the text of
such changes to ensure the agreement is consistent with the terms and
conditions of this registration.
5) BASF shall maintain records of all GMB151 Soybean grower agreements for a
period of three years from December 31
st of the year in which the agreement
was signed.
6) BASF shall make available to the Agency upon request records of the number of
units of GMB151 Soybean 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. BASF is required to submit reports
within three months of the Agency’s request.
7) BASF 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 the names,
personal information, and grower license number will be protected.
c. Resistance Management Education Program
BASF must implement the following resistance management education program:
1) BASF must design and implement a comprehensive, ongoing resistance
management education program designed to convey GMB151 Soybean users the
importance of complying with the RM program. The program shall include
information encouraging GMB151 Soybean users to pursue elements of the
resistance management program relating to best management practices. The
education program shall involve the use of multiple media, e.g. face-to-face
meetings, mailing written materials, and electronic communications such as by
internet or television commercials. The program shall involve at least one
written communication annually to each GMB151 Soybean grower separate
from the grower agreement. BASF shall coordinate its education program with
educational efforts of other organizations, such as the Soybean Cyst Nematode
Coalition, American Soybean Association, and state extension programs.
Education presentations will target growers, university extension, consultants,
internal sales and technical teams, and other appropriate audiences.
Page 5 of 9
EPA Registration No. 7969-434
Action Case No. 00713372
2) Annually, BASF shall revise, and expand as necessary, its education program to
take into account the information collected through the best management
practices survey required under section 7.a and from other sources.
3) Within 90 days of request, BASF shall provide a report to EPA summarizing the
activities it carried out under its education program for the prior year and its
plans for its education program during the current year.
d. Resistance Monitoring
BASF must conduct an annual resistance monitoring program to assess the
susceptibility of the soybean cyst nematode to the Cry14Ab-1 toxin. The resistance
monitoring program must include sentinel plots for surveying for potential
resistance and collection of information from growers about events that may
indicate resistance. The Agency is imposing the following terms:
1) BASF will monitor for resistance in soybean cyst nematodes by the following
methods:
a) Sentinel plots of GMB151 Soybean and comparative non-Bt soybean lines to
monitor the abundance of soybean cyst nematodes in areas of expected high
adoption and resistance risk.
b) Investigations of grower, extension specialist or consultant reports of less
than expected results or control failures of GMB151 Soybean. BASF will
instruct its customers (growers and seed distributors) to contact them (e.g.,
via a toll-free customer service number) if incidents of unexpected levels of
soybean cyst nematode damage occur. BASF must investigate all damage
reports. See section 7.e “Remedial Action Plans” below.
c) For both the sentinel plot and field damage report investigations, EPA
defines “confirmed unexpected injury (UXI)” with the following triggers
based on the number of cysts in 10 sampled plants:
i. An average of 20 cysts per symptomatic plant prior to 60 days after
planting; in case of sandy soils (>70% of sand) and/or alkaline soils (PH t
7.5) the average of 30 cysts per symptomatic plant prior to 60 days after
planting;
ii. An average of 50 cysts per symptomatic plant up to 90 days after
planting; in case of sandy soils (>70% of sand) and/or alkaline soils (PH t
7.5) the average of 75 cysts per symptomatic plant prior to 90 days after
planting;
Page 6 of 9
EPA Registration No. 7969-434
Action Case No. 00713372
iii. Any symptomatic plants documented after 90 days post-planting will be
considered evidence as a confirmed UXI event;
iv. BASF must resample the confirmed UXI field at or after harvest;
v. BASF must implement remedial action measures in response to a
confirmed UXI event – see section 7.e “Remedial Action Plans”.
d) A confirmed UXI event will be considered “putatively resistant” if BASF
samples the field again at or after harvest and collects 4000 eggs/100cm3
soil. If this egg threshold is obtained, BASF will conduct an on-plant
greenhouse bioassay to compare the putatively resistant population of
soybean cyst nematode to a susceptible population. If a significant difference
in survival of these two colonies is observed in GMB151 soybeans, then the
population will be deemed “confirmed resistant.”
i. For all cases of confirmed resistance, BASF must implement remedial
action measures as required in section 7.e “Remedial Action Plans”.
e) BASF is required submit the methodology for the on-plant greenhouse
resistance confirmation bioassay within one year after commercialization of
GMB151 Soybean.
2) Once resistance is first confirmed in a field collection of SCN, it will be reported
to the Agency. BASF will further investigate to 1) Determine if the observed
effect is heritable; 2) Demonstrate that the increased survival is due to resistance
to Cry14Ab-1; 3) Characterize the soil properties in which resistance developed;
4) Determine the geographic extent of the resistance distribution; and 5)
Determine the affected grower’s level of adherence to IPM best practices. BASF
will report to the Agency on these findings and confer with the Agency regarding
additional information needs.
3) BASF must provide to EPA for review and approval any revisions to the soybean
cyst nematode resistance monitoring plans prior to their implementation.
4) A report on results of resistance monitoring and investigations of damage
reports must be submitted to the Agency annually by September 30
th each year
for soybean cyst nematode for the duration of this registration. Additionally,
BASF will meet with the Agency by February 28
th of each year to discuss any
damage incidents or resistance investigations from the previous year.
e. Remedial Action Plans
A specific remedial (mitigation) action plan for soybean cyst nematode is required
for GMB151 Soybean for the purpose of containing resistance and perhaps
eliminating resistance if it develops.
Page 7 of 9
EPA Registration No. 7969-434
Action Case No. 00713372
1) BASF must take the following actions for cases of confirmed UXI or confirmed
resistance:
a) For confirmed UXI or confirmed resistance cases, BASF must hold discussions
with the relevant grower(s) and recommend the following best management
practices:
x Rotate to a non-host crop the season after GMB151 Soybean;
x Eliminate non-crop host plants during the non-host crop rotation;
x Mitigate against soil movement out of the UXI field through sanitation.
b) For confirmed UXI or confirmed resistance cases, BASF must hold discussions
with grower(s) of GMB151 Soybean within the county of the mitigation
action area and recommend the following best management practices:
x Rotate to non-host crop season after GMB151 Soybean;
x Mitigate against soil movement from fields outside of the grower’s
control (e.g., sanitation of shared equipment);
x Monitor GMB151 for UXI, report to BASF if observed.
c) After remediation, BASF must hold discussions with the relevant grower(s)
and recommend the following best management practices:
x Monitor GMB151 Soybean for UXI, report to BASF if observed;
x Plant soybean with alternative genetic source (QTL) of host plant
resistance if resistance confirmation finds virulence to QTL in UXI soybean
crop;
x Use nematocidal seed treatments in subsequent years.
2) BASF must take the following measure for confirmed resistance cases:
x BASF must cease sales of GMB151 Soybean to growers with fields
exhibiting confirmed resistant populations of SCN as well as surrounding
fields.
x Affected customers and extension agents must be notified regarding
confirmed resistance within 30 days;
f. Reports for Sales, Grower Education, and Resistance Monitoring
1) BASF must provide to EPA within 90 days of request:
Page 8 of 9
EPA Registration No. 7969-434
Action Case No. 00713372
a) Annual sales reported and summed by state (county level data will be made
available by request);
b) A report summarizing any substantive changes to the grower education
program completed the previous year.
2) A report on results of resistance monitoring and investigations of damage
reports must be submitted to the Agency annually by September 30th each for
the duration of this registration. BASF will also discuss any cases of putative
resistance with the Agency prior to the subsequent field season by January 31
st.
The report will contain information such as:
a) Number of UXI reports and subsequently confirmed UXI cases in GMB151
Soybean fields, including state and county information.
b) Number of confirmed UXI cases that were assessed to have resistant
populations of soybean cyst nematode.
c) Detailed results and discussion of the resistance confirmation bioassay.
3) A report must be submitted to EPA by September 30
th annually documented the
results of the best management practice survey in section 7.e “Remedial Action
Plans.”
Please note that the record for this product currently contains the following acceptable
Confidential Statement of Formula (CSF):
x Basic CSF dated 3/31/2026
Any CSFs other than that listed above are superseded/no longer valid.
A stamped copy of your labeling is enclosed for your records. This labeling supersedes all
previously accepted labeling. You must submit one (1) copy of the final printed labeling before
you release this product for shipment with the new labeling. In accordance with 40 CFR §
152.130(c), you may distribute or sell this product under the previously approved labeling for
18 months from the date of this letter. After 18 months, you may only distribute or sell this
product if it bears this new revised labeling or subsequently approved labeling. “To distribute or
sell” is defined under FIFRA section 2(gg) and its implementing regulation at 40 § CFR 152.3.
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
U.S. Environmental Protection Agency (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 EPA may consider
Page 9 of 9
EPA Registration No. 7969-434
Action Case No. 00713372
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 EPA find or if it is brought to our attention
that a website contains statements or claims substantially differing from statements or claims
made in connection with obtaining a FIFRA section 3 registration, the website will be referred
to 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.
If you have any questions, please contact David Linz by email at linz.david@epa.gov or by
phone at (513) 569-7538.
Sincerely,
Alan Reynolds, Product Manager 94
Emerging Technologies Branch
Biopesticides and Pollution
Prevention Division (7511M)
Office of Pesticide Programs
Enclosures: Product Label Stamped “Acceptable”
Digitally signed by
ALAN REYNOLDS
Date: 2026.08.17
15:51:29 -04'00'
Plant-Incorporated Protectant Label
GMB151
Plant-Parasitic Nematode-Protected Soybean
(OECD Unique Identifier BCS-GM151-6)
Active Ingredient:
Bacillus thuringiensis Cry14Ab-1 protein and the genetic material necessary for its production (vector
pSZ8832) in GMB151 soybean (OECD ID BCS-GM151-6)……………………….……… < 0.016622%*
Inert Ingredient:
4-hydroxyphenyl pyruvate deoxygenate (HPPD-4) and the genetic material necessary for its production
(vector pSZ8832) in GMB151 soybean (OECD ID BCS-GM151-6)…………..................... < 0.001271%*
*Maximum percent (wt/wt) of dry grain
KEEP OUT OF REACH OF CHILDREN
CAUTION
EPA Registration Number: 7969-434
EPA ESTABLISHMENT NUMBER: 7969-NC-1
NET CONTENTS:
BASF Agricultural Solutions US LLC
2 TW Alexander Drive
Research Triangle Park, NC 27713
08/17/2026
7969-434
DIRECTIONS FOR USE:
It is a violation of federal law to use this product in a manner inconsistent with its labeling.
GMB151 soybean 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 soybean varieties with combined
pesticidal traits.
Soybean has been transformed to express Bacillus thuringiensis Cry14Ab-1 protein for the control of
soybean cyst nematode (Heterodera glycines).
There are no refuge requirements for planting GMB151 soybean.
INTEGRATED PEST MANAGEMENT:
Best management practices are recommended when using Plant-Parasitic Nematode protection. Examples
of appropriate BMPs include but are not limited to:
x Non-host crop rotation after use of Cry14Ab-1 soybeans
x Eliminate non-crop host plants during non-host crop rotation
x Monitoring for unexpected injury
x Sanitation and dispersal limitation measures