perf(epa_ppls): make the monthly refresh fit the runner's 3 h budget (#3)

Co-authored-by: claude <[email protected]>

corpus/epa_ppls/7969-434.md

@@ -4,93 +4,451 @@
 - 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: 2026-04-30
-- Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/007969-00434-20260430.pdf
+- Label accepted: 2026-08-17
+- Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/007969-00434-20260817.pdf
 
 ---
-April 30, 2026 
+August 17, 2026 
  
  
-Andrew Olson, Ph.D. 
+Andrew Olson. Ph.D. 
 U.S. Regulatory Manager 
 BASF Agricultural Solutions US LLC 
-2 TW Alexander Drive 
+2 T.W. Alexander Drive 
 Research Triangle Park, NC 27713 
  
-Subject: Non-PRIA (Pesticide Registration Improvement Act) Labeling and Formulation 
-Amendment – Update the Company’s Name and Address and Removal of Registration 
-Expiration Date 
-Product Name: GMB151 Plant-Parasitic Nematode-Protected Soybean 
+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: 03/31/2026 
-Action Case Number: 00691775 
+EPA Receipt Date: July 28, 2026 
+OPP Action Case Number: 00713372 
  
 Dear Dr. Olson: 
  
-The amended labeling and Confidential Statement of Formula (CSF) referred to above, submitted in 
-connection with registration under the Federal Insecticide, Fungicide, and Rodenticide Act, as 
-amended, are acceptable and the registration expiration date has been removed. 
+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: 
  
-This approval does not affect any additional terms or conditions that were previously imposed on this 
-registration. You must continue to adhere to the registration terms in EPA’s letter dated April 28, 2023. 
+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. 
  
-Please note that the record for this product currently contains the following acceptable CSF: 
+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). 
  
-x Basic CSF dated 03/31/2026 
+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.
+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 2 of 2 
-EPA Reg. No. 7969-434 
-Action Case No. 00691775 
+Page 9 of 9 
+EPA Registration No. 7969-434 
+Action Case No. 00713372 
  
  
  
-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. 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 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. 
+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. 
  
-If you have any questions, please contact Matt Weiner by phone at (202) 566-1509 or via email at 
-weiner.matthew@epa.gov. 
+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 
- E m e r g i n g T e c h n o l o g i e s B r a n c h 
+Alan Reynolds, Product Manager 94 
+Emerging Technologies Branch 
 Biopesticides and Pollution 
  Prevention Division (7511M) 
 Office of Pesticide Programs 
  
- 
- 
-Enclosure: Stamped Label for GMB151 Plant-Parasitic Nematode-Protected Soybean 
+Enclosures: Product Label Stamped “Acceptable” 
 Digitally signed by 
 ALAN REYNOLDS 
-Date: 2026.04.30 
-17:25:55 -04'00'
+Date: 2026.08.17 
+15:51:29 -04'00'
 
-Proposed Plant-Incorporated Protectant Label
+Plant-Incorporated Protectant Label
 GMB151
 Plant-Parasitic Nematode-Protected Soybean
 (OECD Unique Identifier BCS-GM151-6)
@@ -109,7 +467,7 @@ NET CONTENTS:
 BASF Agricultural Solutions US LLC
 2 TW Alexander Drive
 Research Triangle Park, NC 27713
-04/30/2026
+08/17/2026
 7969-434
 
 DIRECTIONS FOR USE: 
@@ -125,3 +483,14 @@ Soybean has been transformed to express Bacillus thuringiensis Cry14Ab-1 protein
 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