# EPA Reg. No. 524-522 Vol. 3

# Memorandum Date: ') 10) 

# I 0 

# 'i 

# To: __ 

# ---'P'---iVt'--"1--I-2S1d-"'-- __ , Regulatory Manager From: Information Services Branch, ITRMD Your receipt ofthis data submission is not an indicationthat MRIDs for the enclosed studies have beenposted to OPPIN. We expect that it will be approximately 5 days from the above date before the study-level data is available in OPPIN. 

# Ifyouhave any questions about this process, please contact Teresa Downs (305-5363).
This is a:

# ~+ cot+cV". N'

# "''I,\.""\. <-€..-

# ~~'~)

- So \1 

# jGcru\



# -**\~o**\I

# j

# ~rJ.It r(\qjl?JufcJ..

# 7/'7fCfj 

# jRfully accepted submission 

# o partially accepted submission 

# o rejected submissionUNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### MONSANTO CO MONSANTO COMPANY 1300 I STREET, NW, SUITE 450 EAST WASHINGTON, DC 20005 July 1,2009

Report ofAnalysis for Compliance 

### with PRNotice 86-5 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Thank youfor your submittal of30-JUN-09. Our 

### staffhas completed a preliminary analysis ofthe material. Theresults are provided as follows: Your submittal was found to be infull compliance 

### with the standards for submission of 

### data contained 

### in PRNotice 86-5. A copy ofyour bibliography is enclosed, annotated with Master Record ID's (MRJDs) assigned to each document submitted. Please use these numbers in 

### all future references to these documents. Thank you for your cooperation. 

### Ifyou have any questions concerning this data submission, please raise them

### with the cognizant Product 

### Manager, to whomthe data have beenreleased.

# D Registration opp fdentifier

# ~EPA United States Number Environmental Protection Agency 

# D Amendment Washington, DC 20460 

# IRI Other Application for Pesticide - Section I 1. CompanyfProduct Number 2. EPA Product Manager 3. Proposed Classification

EPA Reg. Nos. 524-478 and 524-522 Dr. Sheryl Reilly CompanyfProduct (Name) PM" 

## IX

## I None 

# 0 Restricted Bollgard® andBoUgard

## u® Cotton 92 5. Name and Address ofApplicant (Include Z!P Code) 6. Expedited Review. In accordance with FIFRA Section

Monsanto Company 3(c)(3) (b){i), my product is similar or identical in composition 800 North Lindbergh Blvd. and labeling to: EPA Reg. No. Saint Louis, Missouri 63167 

# D Check ifthis is a new address Product Name 

### Section -II 

# D Amendment- Explain below. 

# D Final printed labels in response to Agency letter dated 

# D Resubmfssfon in response to Agency letterdated 

# D "Me Too" Application. 

# D Notification
- Explain below. 

# IRI Other
- Explain below. Explanation: Use additional page(s) if necessary. (For section I and Section 11.) Submission of Bollgar<! and Sollgar<! II cotton H. virescens and H. zea susceptibility monitoring reports in field populations collected dU/ing 2008. Section III 1. Matenal This Product Will Be Packa ed In: r"lld-Resistant Packaging Unit Packaging Water Soluble Packaging 

# 2. Type of Container DYes' 

# DYe, DYes 

## D Metal 

## D Plastic 

# r:gJ No 

# r:gJ No 

# r:gJ No 

## D Glass * Certification must It "Yes" No. per If'Yes" No. per 

## D Paper be submitted Unit Packaging wgt. Container Package wgt. Container 

## I.8l Other

. (Sped 3. Location of Net Contents Infonnation 4. Size(s) Retail Container 5. Location of Label Directions 

## D Label 

## D Container 

## D On Label 

## D On Labeling accompanying product 6. Manner in Which Label is Affixed to Product**~** Lithograph 

## D Paper glued 

### [8] Other 

## D Stenciled 

### Section -IV 1. Contact Point Com lete items direc betow foridentification ofindividuat fo be contacted, ifnecessa , to process thfs a lication. Name Title Telephone No. (lncludeArea Code) Russell P. Schneider, Ph.D. Sr. Dir. U.S. Regulatory Affairs & (202) 383-2866 Policy Certification 6. Date Application t certify that the statements thave made on fhis form and af! attachments therefo are true, accurate and complete. Received I acknowledge thafanyknowingly false ormisleading statement maybe punishable byfine orimprisonment or (Stamped) both underapplicable taw.

## 2.Si9tL&f~

# fJ~ 

# ts 3. Title Regulatory Affairs Manager, Cotton 4. Typed Name 5. Date Patricia G. Kelle,> PhD. (314) 694-8271 June 29, 2009 E

. 3-94 Previous editions are obsolete.

PA Form 8570 1 (Rev 

## - White· EPA File Co 

### on py( ginal Yellow-A pplicant Copy

### MONSANTO 

## 1m ine 477913'()O



### June 29, 2009 Soo NORTH LIN08ERQH SlVO ST. LOUIS. M'SSOURI 6,,67 http:.!/www.monsanto.com 

### DocumentProcessingDesk Office ofPesticide Programs (7504P) U.S. Environmental ProtectionAgency Room S-4900, OnePotomacYard 2777 South Crystal Drive Arlington, VA 22202-4501 To: Dr. Sheryl Reilly. Biopesticide and PollutionPrevention Division Subject: Submission ofthe 2008 CrylAc and Cry2Ah2 monitoringreports for Bollga.-d® and Bollgard I.r® cottonrequired as conditions ofregistrations (EPA Reg. Nos. 524-478 and 524-522, respectively). DearDr. Reilly: As a condition ofthe June 23,2006 and June 1,2007registrations for Bongard and Bollgard II cotton, respectively, Monsanto is required to supply annual monitoring reports

### for'Heliothis virescens (tobacco budwonn) 

### Helicoverpa zea (cotton bollworm), and

### Pectinophoragossypiella (pinkbollworm), includingreviews ofthe data from the previous growing season. Herewith we report on the first two ofthese tlrree species. Per agreement with U.S. EPA, the report on

### P. gossypiella willbe submittedbyDecember 15,2009. TIlls submission includes the following volumes: • Volume 1, report entitled: "Submission Summary": Results of2008 Studies

.. Volume 2, report entitled: "Monitoring

### Helicoverpa zea Susceptibility to CrylAc and Cry2Ab

### B.t. Toxins: Results of2008 Studies" • Volume 3, report entitled: "Diet OverlayBioassays with Cry2Ab ReduceExperiment-Wise Variation and Enhance Resistance Discrimination in

### Helicoverpa zea, Relativeto Diet Incorporated Bioassays: Conclusions from MonitoringResistance inthe US in 2008" • Volume4, report entitled: ''Monitoring

### Helicoverpa zea Susceptibilityto 

### B.t. Toxins: Results of2008 PlantAssays" • Volume 5, report entitled: "Monitoring Susceptibility ofField Populations of

### Heliothis virescens to 

### B.t. ToxinCry1Ac: 2008 Collections and Assays" • Volume 6, report entitled: "Monitoring Susceptibility ofField Populations of

### Heliothis virescens to 

### B.t. Toxin Cry2Ab2: 2008 Collections and Assays"

® Bollgard andBollgardII areregistered trademarks ofMonsanto Technology LLC.
04-CT-133E-50 and 04-CT-134E-50 

# ')Dr. Sheryl Reilly Environmental ProtectionAgency June 29, 2009 Page 2 of4 

### Volume 1 is a summary ofall the reports that comprise this submission. Complete reports arebeing submitted (see attached Volumes 2-6) to fulfill the conditions of registration for both Bollgard and Bollgard II cotton. Volume 2 is a report describing the susceptibility to CrylAc and Cry2Ab2

### B.ttoxins of 24 field populations ofH 

### zea collected in'the U.S. during the 2008 cotton growing season. This monitoring was conducted byDr. Ibrahim Ali and Dr. Randall G. Luttrell of the University ofArkansas inFayetteville, AR. Both diet incorporationbioassays and diet overlay bioassays with the CrylAcprotein showed no evidence ofsignificant changes in 

### susceptibility from 2007 to 2008. For Cry2Ab2, there were approximately 10% increases in2008, relative to 2007, in percent ofH 

### zea larvae developing to orbeyond the second larval stage in diet incorporation bioassays of!00 and 150 !!g Cry2Ab2/ml diet. Although Ali and Luttrell concluded that this change was not likely ofpractical significance, Monsanto undertook extensive additional studies to investigate these survivors ofdiscriminating concentration bioassays (Volume 3). Volume 3 deals onlywith H 

### zea, whileH 

### virescens is reviewed involumes 5 and 6. Volume 3 describes theresults ofdiet-overlay and diet incorporation bioassays with Cry2Ab2 with

### H zea. The overlaymethod is advantageous becausetoxinis concentrated in a layer ontop ofthe insect diet, through which insect must feed. In

### this manner, the diet overlay method increases the amount oftoxin to which larvae are exposed and therein reduces LCx 

### values. This makes itpossible to establish the upper range ofthe mortalityresponses offieldinsects to Cry2Ab2, andto show that survivors ofdietincorporation bioassays did not possess major genes for resistance to this toxin. We conclude that the diet overlay method is superior to the diet incorporation for diagnostic concentration bioassays of 

### H zea. Volume 4 describes research that was conducted at the University ofArkansas (Ali and Luttrell), relating laboratory bioassay data to survival and development ofH. 

### zea fed conventional, Bollgard, Bollgard II, orWideStrike TM 

### plant material. Results indicated that, while field and selected strains differed in survival on different plant types, survival to pupation was verylow, reinforcing the conclusion that the field and selected strains did notpossess major resistance genes. Volumes 5 and 6 describe evaluations ofsixteen field strains ofH. 

### virescens, collected in 2008, for susceptibility to CrylAc and Cry2Ab2, respectively. All were highly susceptible and unchanged from 2007.**~** WideStrike is a registered trademark ofDowAgroSciences LLC.

04-CT-133E-SO and 04-CT-134E-SODr. Sheryl Reilly Environmental Protection Agency June 29,2009 Page 3 of4 

### Monsanto is required to submit, annually, any proposed changes to protocols for the aforementioned monitoringprograms. Pursuant to that requirement, we submit the following: I. Although the 2009 field collections of 

### H. virescens and

### H zea will bemade as in 2008, after they are reared atthe Monsanto facility inUnion City, TN,

### bothH. zea and H 

### virescens will be shipped to Custom Bio-Products (Maxell, IA) for monitoring bioassays, instead ofbeing shipped to the University ofArkansas where the bioassays were conducted in the past. 2. The 2009

### H zeabioassayprotocol, previously used byDr. Ali and Dr. Luttrell at the University ofArkansas, will be utilized byCustomBio-Products. Custom Bio-Products will conduct diet-incorporation assays similarlyto previous years with standardized diagnostic concentrations for both CrylAc and Cry2Ab2. 

### In addition, in 2009 and for future 

### H. 

### zea evaluations, the diet-overlaybioassay will beused. Diet-overlaybioassays forboth CrylAc and Cry2Ab2 will be conducted, to provide bridging studies that will facilitate ourfuture transition to diet overlaybioassays fur H 

### zea. Therrotocol for the diet-overlaybioassay will be submitted to EPA by December 15' 2009. 3. The 2009 P. 

### gossypiella monitoring protocol contains no substantive changes from 2008. However, it shouldbe noted that execution ofthis program maybe negatively impacted by success ofthe pinkbollwonn (PBW) eradication program, which may limit the population size available for collection. It

### maybe particularly difficult to obtain enough live PBW larvae infields in 2009 to establish strains for bioassays. Therefore, going fOIWard, the DNA screening (bioassays and DNA screening methodology are described 

### inthe protocols fur P. 

### gossypiella monitoring) ofmoths caught inpheromonetraps will beparticularly important, since it will be very difficult to obtain field collections oflive PBW due to the ongoing eradication program. Finally, Monsanto isrequired to provide informationregarding any investigations of"less than expected results orcontrol failures" for thetarget pests 

### inBollgard or Bollgard II cotton fields. In

### 2008, there was one report, in southeast Texas, ofunusual survival of 

### H. 

### zea in a Bollgard cotton field. This complaint was investigated byDr. Jorge Cuarezma, Technical DevelopmentRepresentative ofMonsanto. He determined that the damage caused bybollworms in the'field ofinterest was well within the expected limits for unsprayed Bollgard cotton. There wereno otherreports ofunsatisfactory field perfonnance ofBollgard or Bollgard 1I in the U.S. in2008.

04-CT-133E-50 and 04-CT-134E-50Dr. Sheryl Reilly Environmental ProtectionAgency June 29, 2009 Page4of4 

### Please find enclosed copies' ofthe following documents:
• Transmittal document • Application for Pesticide (EPA Fonn 8570-1) • Volume I, report entitled: "Submission Summary": Results of2008 Studies • Volume 2, report entitled: "MonitoringHelicoverpa zea 

### Susceptibility to CrylAc and Cry2Ab2 B.t. 

### Toxins: Results of2008 Studies" • Volume 3, report entitled: "Diet Overlay Bioassays with Cry2Ab Reduce Experiment-Wise Variation and Enhance Resistance Discrimination inHelicoverpa zea, 

### Relative to Diet Incorporated Bioassays: Conclusions from MonitoringResistance in

### the US in 2008" • Volume 4, report entitled: "MonitoringHelicoverpazea 

### Susceptibility to B.t. 

### Toxins: Results of2008 Plant Assays" • Volume 5, report entitled: "Monitoring Susceptibility ofField Populations of He Iiat his virescens to 

### B.t. 

### Toxin CrylAc: 2008 Collections and Assays" • Volume 6, report entitled: "Monitoring Susceptibility ofField Populations ofHeliothis virescens to 

### B.t. 

### Toxin Cry2Ab2: 2008 Collections and Assays" Please contact Dr. Russell Schneider at 202-383-2866 or me at 314-694-8271 if

### you have any questions regardingthese reports. Sincerely,

Patricia G. Keller, Ph.D. Cotton Regulatory Affairs Manager
cc: Denise Greenway Russell Schneider

04-CT-133E-50 and 04-CT-134E-50

### TRANSMITTAL DOCUMENT SUBMITTED BY Monsanto Company 800 North Lindbergh Blvd. Saint Louis, Missouri 63167

REGULATORYACTION IN SUPPORT OF WHICH THIS PACKAGE IS SUBMITTED Submission ofthe 2008 CrylAcand CryZAb2 monitoring reports for Bollgard® and Bollgard I.r® cotton required as conditions oftheregistrations 

### EPA Reg. Nos. 524-478 and 524-522

TRANSMITTAL DATE June 29, 2009
• Application for Pesticide (EPAForm 8570-1) • Volume 1, report entitled: "Submission Summary": Results of2008 Studies • Volume 2, report entitled: "Monitoring

### Helicoverpa zea Susceptibility to CrylAc and Cry2Ab2 B.I. 

### Toxins: Results of2008 Studies" • Volume 3, report entitled: "Diet Overlay Bioassays with 

### Cry2Ab Reduce Experiment-WiseVariation and Enhance Resistance Discrimination inHelicoverpa zea, Relative to Diet Incorporated Bioassays: Conclusions from Monitoring Resistance inthe US in 

### 2008" • Volume 4, report entitled: "MonitoringHelicoverpa zea Susceptibilityto B.I. 

### Toxins: Results of2008 Plant Assays" • Volume 5, report entitled: "Monitoring Susceptibility ofField Populations 

### of Heliothis virescens to 

### B.t. Toxin CrylAc: 2008 Collections and Assays" • Vohune 6, report entitled: "Monitoring Susceptibility ofField Populations of Heliothis virescens to B.t. Toxin Cry2Ab2: 2008 Collections and Assays"

® Bollgard and Bollgard IT are registered trademarks ofMonsanto Technology LLC. 04-CT-133E-50 and 04-CTT134E-50 Page 1 of4

### LIST OFSUBMITTED DOCUMENTS
Volume 1: Dennehey, T.J. 2008. Submission Summary: Results of2008 Studies. 04-CT-133E-50 and 04-CT-134E-50 Volume L


### MRID Number __ 4_77_9_1_3_01'-- __________________ _ 

### Volume 2: 

### Ali, M.L, and R.G. Luttrell. 2008. Monitoring

### Helicoverpa zea Susceptibilityto CrylAc and Cry2Ab2B.t. 

### Toxins: Results of2008 Studies. 04-CT-133E-50 and 04-CT-134E-50 Volume 2. Unpublished studyprepared bythe University ofArkansas.


### MRID Number
__ 4_7_79_1_30_2-:-
_________________ _ Volume 3: Anilkumar, et aI. 

### 2009. Diet Overlay Bioassays with CryZAb Reduce Experiment-Wise Variation and Enhance Resistance Discrimination in 

### Helicoverpa zea, 

### Relative to Diet Incorporated Bioassays: Conclusions from Monitoring Resistance inthe US in 

### 2008. 2009 Beltwide Cotton Conference.


### MRID Number _-.:4:.;,7.:..79=-1:..:3-'03
___________________ _ Volume 4: 

### Ali, M.L, and R.G. Luttrell. 2008. MonitoringHelicove1pa zea 

### SusceptibilityB.t Toxins: Results of2008 Plant Assays. 04-CT-133E-50 and 04-CT-134E-50 Volume 4. Unpublished studypreparedbythe University ofArkansas.


### MRID Number
__ 4_7_7_91_3_o_4
__________________ _ Volume 5: 

### Lang, R 2008. Monitoring SusceptibilityofField Populations ofHeliothis 

### virescens 

### to B.t. 

### Toxin CrylAc: 2008 Collections and Assays. 04-CT133E-50 and 

### 04-CT-134E-50 Volume 5. Unpublished studypreparedby CustomBio-Products.


### MRID Number ___ 4_7_7_9.:..13_0:...5 __________________ _

04-CT-133E-50 and 04-CT-134E-50 Page 2 of4

### Volume 6: 

### Lang, B. 2008. Monitoring Susceptibility ofField Populations ofHeliothis virescens to B.t. Toxin Cry2Ab2: 2008 Collections and Assays.**04~CT** 

### 133E-50 and 04-CT-134E-50 Volume 6. Unpublished studyprepared by Custom**Bio~Products.** MRID 

### Number
___ 4_7_7_91_3_o_8
_________________ _

04-CT-133E-50 and 04-CT-134E-50 Page 3 of4

### COMPANYNAME: Monsanto Company



### COMPANY OFFICIAL: Patricia G. Keller, Ph.D., Regulatory Affairs Manager



### DATE: June 29, 2009

COMPANY CONTACT: Dr. Russell Schneider (202) 383-2866

04-CT-133E-50 and 04-CT-134E-50 Page4 of4Yes 

# i.' No



### ,".,



## FEB 10 Z009

## MONSANTO

# ~

January 29, 2009 Document Processing Desk Office ofPesticide Programs (7504P) U.S. Environmental Protection Agency Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202-4501 To: Dr. Sheryl Reilly, Biopesticide and Pollution Prevention Division 478689.00

i"lOrdANTO COiA?ANY 800 N. L!N08oRGfl BLVO. ST. LOlliS, M!SSOUR! 6)!67 nttp:llwww.monsanto.com

Subject: Submission ofthe 2008 Bollgard® and Bollgard II® cotton compliance assurance programreport, required condition ofregistrations (EPA Reg. Nos. 524-478 and 524-522). DearDr. Reilly: As a condition ofthe June 23, 2006 and September 16,2008 amended registrations for Bollgard and BollgardII cotton (EPA Reg. Nos. 524-478 and 524-522), respectively, EPA

### required that Monsanto submit an annual report that summarizes the compliance assurance program 

### (CAP).
. As inprevious years, random cotton farmers were surveyed acrossthe cotton growing regions ofthe U.S. In2008, fanners thatplanted Bollgard II cotton 

### innatural refuge areas or fanners thatplanted Bongard and/or BongardII cotton and participated inthe Pink BollwormEradicationprogram were not included inthe survey. Dueto this exclusion, the number ofqualifiedparticipants inthe survey drastically decreased, as the majority offanners contacted lived 

### innatural refuge areas and chose to plantBollgard II cotton. Please find enclosed copies ofthe following documents: • Transmittal document • Application for Pesticide Registration (EPA Form 8570-1) • Volume 1 of 1: "2008 Bollgard® and Bollgard Ir® Cotton Insect Resistance Management Compliance Assurance Program Report" (three copies)

® Boligard and Bollgard II areregislered trademarks ofMonsanloTechnolOgy LLC. 04-CT-133E-46 and 04-CT-134E-46 Page I oflDr. Sheryl ReiIly U.S. Environmental Protection Agency January 29, 2009 

### Page 2 of2 If

### you have any questions regarding this submission, please contact me at 314-694-7556 or Dr. Russell P. Schneider at 202-383-2866. Sincerely, 

## ( I 

# j I, ! 

# -l v 

## flU·fA'-t7 '-

Melinda 

### C. McCann Cotton Regulatory Affairs Manager
cc: Denise Greenway Russell P. Schneider

04-CT-133E-46 and 04-CT-134E-46

### TRANSMITTALDOCUMENT SUBMITTED BY Monsanto Company 

### 800 North Lindbergh Blvd. St. Louis, 

### MO 63167 REGULATORYACTION IN SUPPORT OF WHICH TIDS PACKAGE IS SUBMITTED Submission ofthe 2008 Bollgard® and Bollgard II® cotton compliance assurance programreport, required condition ofregistrations (EPA Reg. Nos. 524-478 and 524- 

### 522). TRANSMITTALDATE January 29, 2009 LIST OF SUBMITTED DOCUMENTS
Volume 1: McCann, 

## M,e. and Carden, 

### 1.A. 2009. 2008 Bollgard® and Bollgard 

## n® Cotton Insect Resistance Management ComplianceAssurance Program 

### Report. 04-CT-133E-46 and 04-CT-134E-46. An

### unpublished report prepared by Monsanto Company.

MRID 

### Number
_____ 4_7_8_5_89_0_1
____________ _



### COMPANY NAME: MonJ:lantoc 

### pany 

# - ' C**~**

# COMPANYOFFICIAL:~ .

# tJ~ Melinda C. McCann 

### Cotton Regulatory Affairs Manager
DATE: January 29, 2009
COMPANY CONTACT: Dr. Russell P. Schneider (202) 383-2866

® Bollgard and Bollgard II are registeredlrademarks ofMonsanto Technology LLC. 

### 04-CT-133E-46 and 04-CT-134E-46 Page loflUNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON. D.C. 20460


### Februmy

### 4,2009
MONSANTO COMPANY 

### 1300 I STREET, NW. SUITE 

### 450 EAST WASHINGTON, DC 

### 20005 Report ofAnalysis for Compliance with PR Notice 86-5 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Thank you for your submittal of02-FEB-09. Our staffhas completed a preliminmy analysis ofthe material. Theresults are provided as follows: Your submittal was found to be in full compliance with the standards for submission of data contained in PR Notice 86-5. A copy ofyourbibliographyis enclosed, annotated with Master Record ID's (MRIDs) assigned to each document submitted. Please use these numbers in all future references to these documents. Thank you for your cooperation. Ifyou have any questions concerning this data submission, please raise them with the cognizant Product Manager, to whom the data have beenreleased.Please read instructions on reverse before com lelina form. Form Approved. OMS No. 2070-0060. Approval EXpires 2-28-95 

# D Registration OPP IdentifierNumber 

# &EPA United States 

### Environmental Protection Agency 

# D Amendment Washington, DC 20460 

## (g] Other



### Application for Pesticide - Section I 1. CompanylProduct Number 2. EPA Product Manager 3. Proposed Classification Monsanto / EPA Reg. Nos. 524-478 and524-522 Dr. SherYl Reillv 4. CompanylProduct (Name) PM. 

## lliJ None D Restricted Monsanto I Bollo-ard® and Bollgard U® cotton 92 5. Name and Address ofApplicant (Include ZIP Code) 6.Expedited Review. In accordance with FIFRA Section 3(c)(3) (b}(i), my

Monsanto Company product is similar or identical in composition and labeling to: 800 North Lindbergh Blvd EPA Reg. No. St. Louis, MQ 63167 

# D Check ifthis is a new address Product Name Section- II 

# D Amendment

- Explain below. 

# D Final printed labels in response to Agency letter dated 

# D Resubmission in response to Agency letter dated 

# D "Me Too" Application. 

# D Notification

- Explain below. 

### [Rl Other

- Explain below. Explanation: Use additional page(s) ifnecessary. (For section Iand Section II.) Submission ofthe 2008 Bollgard and Bollgard II cotton compliance assurance program report, required condition of registrations (EPA Reg. Nos. 524-478 and 524-522). 

### Section
- III I. Material This Product Will 8e Packa ed In: Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type ofContainer DYes' DYes DYes 

# o Metal 

## lliJ No 

## IR1 No 

### [RlNo 

# o Plastic 

# o Glass * Certificatron must If "Yes" No. per If "Yes" No. per 

# o Paper be submitted Unit Packaging wgt. Container Package wgt. Container 

## lliJ Other (Specify) 3. Location 01 Net Contents Information 4. Size{s} Retail Container 5. Location ofLabel Directions



# o Label 

# o Container Various 

# o On Label 

# o On Labeling accompanying product 6. Manner in Which Label is Affixed to Product 

# o Lithograph 

# o Paperglued 

### [Rl Other 

# o Stenciled Section IV 1. Contact Point Complete ilems directl belowfor Identlficalion ofindividUal to be contacted, Ifnecessa ,to process this a lication. Name Title Telephone No. (Include Area Code) Russell P. Schneider, Ph.D. Regulatory Affairs, Director (202) 383-2866 Certification 6. Date Application I certify Ihallhe stalements Ihave made on this form andall attachments thereto are true, accurate and comple/e. Received I acknowledge**~~bany** knowingly false ormisleading statemenlmaybepunishable byfine orimprisonment or (Stamped) both undera Ii bte law. 

# 2t"**tj~J;: ~(1** 

# .U~ 3. Title Cotton Regulatory Affairs Manager 4. Typed Name 5. Date Melinda C. McCann January29,2009 (314) 694-7556



## - d·
. 

### - 

### . . 

## - EPA Form 85701 (Rev. 3-94) PreVIOUS e Itlons are obsolete. White EPA File Copy {onglnal} Yellow Applicant Copy
04-CT-133E-46 and 04-CT-134E-46

# f;••**~=i'j~rr;J~:.;**

# .• "jBiO'09ica,s & Pollution 

### ,);';\;entlc<, 

### c,

## }:~~or"**~~~~:' 8-:;~** **;~** #: 524_522 

## 1**Pror\J':-~ ~J.3m,;** **~"., ~(""** **~D** II COF'"·!'! 

# -----_.

h9-Jan-2009 

### , p2-FefJ_2008**r---'~'-'** M", To:; Product N: -';;' 

# v



# ---- ..,

i< View[Edit

1...;....;..,..;..----- _. , ___ . ___ -___**.~"~**_______ .;..,..;...;..,..;..--:..;;1 

# FEB 102009 

# f'6"U \I> \\R. Q

## I II 

# I 

# oq

### MONSANTO

# ~

MONSAN70 COMPANY 800 N. LINOBERGN S"vo. 476590-00

January 29, 2009 S•. LouIs, hllIssouRI 63167 http://www.moDSanlo.com Document Processing Desk Office ofPesticide Programs (7504P) U.S. Environmental Protection Agency Room 8-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202-4501 To: Dr. Sheryl Reilly, Branch Chief Biopesticide and Pollution Prevention Division Subject: Submission ofBollgard U® cotton seed units sold in the U.S. in 2008, required condition ofregistration (EPA Reg. No. 524-522). Dear Dr. Reilly: As a condition ofthe September 16, 2008 amendedregistration for Bollgard II cotton, EPA Reg. No. 524-522, EPA required that Monsanto submit an annual report on the number ofunits ofBollgard II cotton seed sold (shipped) and not returned, and an estimate ofacres planted in the U.S. Furthermore, EPA required that Monsanto specify the number ofBollgard II cotton seedunits sold to persons who have signed fanner license agreements. Please find enclosed copies ofthe following documents: • Transmittal document • Application for Pesticide Registration (EPA Form 8570-1) • Volume I of I: "Bollgard

# n® Cotton Seed Units Sold in the U.S. in 2008." (three copies) As required to estimate acres, Monsanto has converted the state sales data to an estimate ofacres plantedby state. However, Monsanto believes that this estimate is not an accurate representation ofthe actual number ofacres plantedin a state for the following reasons: l) regional differences in cotton planting densities across the U.S. range from 4.2 to 5.0 acres plantedperbag ofcotton seed purchased (the estimated acreage planted was calculated using a conservative conversion factor ofone unit sold per4.2 acres planted); and 2) Monsanto's sales database depicts county-specific seed sales, but there is no guarantee that the seed was planted in the county or the state where the sale occurred.

El Bollgard II is a registered trademark ofMonsanto Technology LLC. 04-CT- 133E-45 Page lof2 , " ,Dr. Sheryl Reilly U.S. Environmental Protection Agency January 29, 2009 Page 2 of2 The number ofBollgard II cotton seed units sold to persons who have signed a fanner license agreement is included in Volume 1 oftrus submission. Ifyou have any questions regarding this submission, please contact me at 314-694-7556 or Dr. Russell P. Schneider at 202-383-2866. Sincerelyr ( . 

# vrwI;J/ (I

# ·lAl!ri~--

Melinda C. McCann Cotton Regulatory Affairs Manager
cc: Denise Greenway Russell P. Schneider

04-CT-133E-45 • v, ,

". , ,TRANSMITTAL DOCUMENT SUBMITTED BY Monsanto Company 800 North Lindbergh Blvd. St. Louis, MO 63167 REGULATORY ACTION IN SUPPORT OF WHICH THIS PACK"GE IS SUBMITTED Submission ofBolIgard

# n® cotton seed units sold in theU.S. in 2008, required condition ofregistration (EPA Reg. No. 524-522).
TRAi'lSMITT AL DATE January 29, 2009 LIST OF SUBMITTED DOCUMENTS
Volume 1: McCann, 

## M.e. and Carden, l.A 2009. Bol1gard 

## n® Cotton Seed Units Sold in the U.S. in 2008. 04-CT-133E-45. An unpublished reportprepared by Monsanto Company.

MRID Number
______ 4_78_5_9_00_1 ___________

### ~

COMPANY NAME: Monsanto Company 

# ( ! I, 

# i

# -C (T . ( 

# I{/:'r, COMPANY OFFICIAL:

## _y~w~~=':'d"'__~-'-/v--=w"'-.-,~-----­ Melinda C. McCann Cotton Regulatory Affairs Manager
DATE: January 29, 2009
COMPANY CONTACT: Dr. Russell P. Schneider (202) 383-2866

o Bollgard II is a registered trademark ofMonsanto Technology LLC. 04-CT-133E-45 Page 1 of 1 ,.Co, ,,, __ 

# .' (. , 

### , c.'_·C.L- '-'UN., ED STATES ENVIRONMENTAL PROTEC. ,ON AGENCY WASHINGTON, 

### D.C. 20460


### February 3, 2009
MONSANTO COMPANY 1300 I STREET, NW, SUITE 450 EAST WASHINGTON, DC 20005 Report ofAnalysis for Compliance with PRNotice 86-5 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Thank you for your submittal of02-FEB-09. Our staffhas completed a preliminary analysis ofthe material. Theresults are provided as follows: Your submittal was found to be in full compliance with 

### the standards for submission of data contained in PRNotice 86-5. A copy ofyour bibliography is enclosed, annotated with Master Record ID's (MRIDs) assigned to each document submitted. Pleaseusethese numbers in all future references to these documents. Thank: you for your cooperation. Ifyou have any questions concerning this data submission, pleaseraise them with the cognizant Product Manager, to whom the datahavebeenreleased.

# Memorandum Date:**~** 

# / 07 / 0 9 

# To: 

# R P P D ('1 (}- ) , Regulatory Manager From: Information Services Branch, ITRMD Yourreceipt ofthis data submission is not an indication that MRIDs for the enclosed studies have been posted to OPPIN. 

# We expect that it will be approximately 5 days from the above date before the study-level data is available in OPPIN. Ifyou have any questions about this process, please contact TeresaDowns (305-5363).
This is a:

# ~fully accepted submission D 

# partially accepted submission 

# Drejected submission

# &EPA

I. Company/Product Number United States 

### Environmental Protection Agency Washington, DC 20460**Fo~.**

•for ,- OMS No. 

## f== Registration Amendment 

## ='3(1 I.:!:!.I Other 

### II 2. EPA Producl Manager ,/EPAReg. No. Dr. Sheryl Reilly 4. CompanylProduct (Name) PM< III cotton 92 I i opp IdentifierNumber

3. Proposed**Crassifica~on** 

### [8J None 

# 0 Restricted 5. Name and Address ofApplicanl (Include ZIP Code)

Monsanto Company 6.Expedited Review. in accordance with FIFRA Section 3(c)(3) {b)(iJ, my product is similar oriden\ical in composition and labeling to: 800North Lindbergh Blvd St. Louis, MQ 63167 EPA Reg. No. _______________ _ 

# I

# n Check i/ this is a new address Product Name



# O Amendment _ Explain belOW. 

### I Final pJinled labels in response 10 

# F Agency letter dared 

# o Resubmission in response to Agency letter dated L "MeToo" ApplicarlOn. 

# I

# n Notification
- Explain beloW. 

### [8] Other
- Explain below.

# su~misSio~**ofBoll~ard** II

# co~on seed

# ~ts**5o~d** in

### the

# u.~."~ 2008, required condition ofregistration (EPA Reg. I 

### No. " I 

# ._J[o----------------i

Child-Resistanl Packaging

### DY~· [8J No "Certification must be submitted Unil Packaging DYes 

### [8J No

3. Location 0/ Net COnlenls Information 

# D Label 

# D Container 6. Manner in Which Label is Affixed 10 Product

Name Russell P. Schneider, Ph.D. Waler Soluble Packaging DYes 

### 1:&:1 No I ,,,'**~o.** poe

4. Size{s) Retail Container Various 

## I' 

# fl-j':**~** Melal 

### r= Plasnc = Glass 

# ®Paper

. . "fL,b,II 

# j On Label Lilhograph Paper glued 

### [8J OlheC' _____________ _ ·IV Title Regulatory Affairs, Director Telephone No. (Include Area Code) (202) 383,2866

# :~~~~~~~~·~**'~~~~~~~~~~~~~~~~~~~~~~:~=l~6'. ~D~"~'~r"lf;~licatiOn**  I certify thallhe ) "**~** on this form and; true, accurate and comple/e. Received**~~r;now/edge ~~al.'**  I I' orimprisonment or (St::1lllped)

# 12'\'~A, I.-ft.' 

# 'J.**~**

# .. 16,.A

_ ___ . I" "" -1.\
.

### i 

## l'A. j**~** 

### j./1U

.....**~_** 

### _ _ Cotton Regulatory Affairs Manager

14

. Typ" N,m'Melinda C. McCann 

## I'D'" January 29, 2009 

# I (314), ,< EPA**Fo~** as?"" (R".

## "94, ' , I Copy 

### 04,CT-I33E-45

### reid..- 

## fir/or 

## /fltln 5 Q

### ,¢ 

## f, beQh 

# J.**~** 

# hi"';**f~** (m6y S<'/

-

## h',,~ 

# ,1- (//?b..-f./;' 

## 5 

# h'l#JJ-?rn. .J w 

### ha **CQ** I-, **r-(** (//4v **Ii** 

# un /h

# rJ'*'""-<t/c 'f

## Itel f1

.. ) fuIJ'tDecember 11, 2008 Document Processing Desk 

### MONSANTO 

## im"gine

Office ofPesticide Programs (7504P) U.S. Environmental Protection Agency Room 5-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202-450I To: Dr. Sheryl Reilly, Biopesticide and Pollution Control Division MONSANTO COMPANY**8D~** NORTH LINDBERGH BLVO Sr. Lours,**MISSO\)~I** 6,r67 http:;'1www**.nJDns~nlO_com**

Subject: Submission ofreport entitled "Susceptibility ofPink Bollworm to 

### B.t. Toxins CrylAc and Cry2Ab2 in 2007," a condition ofthe Bollgard® and Bollgard lI® cotton registrations (EPA Reg. Nos. 524-478 and 524-522). Dear Dr. Reilly: As a condition ofthe June 23, 2006 and September 16, 2008 amended registrations of Bollgard and Bollgard II cotton (EPA Reg. Nos. 524-478 and 524-522), respectively, Monsanto is required to submit annually a report on results ofpink bollworm 

### (Pectinophora gossypiella) susceptibility monitoring. The purpose ofthe monitoring is to assess potential emergence ofinsect resistance to Cry IAc and Cry2Ab2 proteins. Enclosed is a report prepared by Dr. Bruce Tabashnik at The University ofArizona and colleagues at the Arizona Cotton Research and Protection Council, which fulfills this condition ofthe registrations. In 2007, a total of II strains ofpink bollworm were collected from cotton fields in Arizona. California, and Texas. These strains were cultured in the laboratory and tested for susceptibility to CryLA.c and Cry2Ab2 using diagnostic concentrations of 1.0 and 10 }lg protein/mL ofdiet. The report states that there is no indication ofpink bollwonn resistance development to CrylAc or Cry2Ab2 at the locations sampled in 2007.

® Bollgard and Bollgard II are registered trademarks ofMonsanl0 Technology LLC. 

### 04·CT.J33E·47 and 04·CT·J34E47 Page I of2 478224.00Dr. Sheryl Reilly U.S. Environmental Protection Agency.

Please find enclosed copies ofthe following documents:

• Transmittal document 

### • Application for Pesticide (EPA Fonn 8570-1) December II, 2008 Page 2 of2

• Volume I of 1: Report entitled: "Susceptibility ofPink Bollworm to B.t. Toxins CrylAc and Cry2Ab2 in 2007" (three copies) Please contact Dr. Russell Schneider at 202-383-2866 or me at 314-694-7556 ifyou have any questions regarding this report. Sincerely,

# ~(lJJ~ Melinda C. McCann Cotton Regulatory Affairs Manager
cc: Denise Greenway Russell Schneider

04-CT-133E-47 and 04-CT-134E-47**TR~NSMITT**AL DOCUMENT SUBMITTED BY Monsanto Company 800 North Lindbergh Blvd. S1. Louis, Missouri 63167
REGULATORY ACTION IN SUPPORT OF WHICH THIS PACKAGE IS SUBMITTED EPA Reg. Nos. 524-478 and 524-522 Submission ofreport entitled "Susceptibility ofPink Bollworm to B.t. Toxins Cry} Ac and Cry2Ab2 in 2007," a condition ofthe Bollgard® and Bollgard 

### JI® cotton registrations.**T~SMITTAL** DATE December 11. 2008 LIST OF SUBMITTED DOCUMENTS Volume 1: Tabashnik, 8., T. Dennehy, L. Antilla, C. Unnithan, and V. Harpold. 2008. Susceptibility ofPink Bollworm to B.t. Toxins CrylAc and Cry2Ab2 in 2007. An unpublished report written 

### by researchers at The University of Arizona and Arizona Cotton Research & Protection Council.


### MRID Number
___**4.:.:7.:.:6~2~24_0_1**________________ _ COMPA1\'Y NAME: Monsanto Company

# COMPANYOFFICIAL:~0 {J.

# U~ Melinda C. McCann, Regulatory Affairs Manager DATE: December 11, 2008 COMPANY CONTACT: Dr. Russell Schneider (202) 383-2866

® Bongard and Bollgard II are registered trademarks ofMonsanto Technology LLC. 04-CT-133E-47 and 04-CT-134E-47 Page 1 of 1United States Environmental Protection Agency Washington, DC 20460 = 

# lID Registration Amendment OPP Identifier Number

1. Company/Product Number

EPA Reg. Nos. 524-478 and and 

## n® Cotton 5. Name andAddress ofApplicant (Include ZIP Code)

Monsanto Company 800 N. Lindbergh Blvd. St. Louis, MO 63167 

# D Check itthis is a new address

Amendment - Explain below. Resubmission in response to Agency letter dated Notification
- Explain below. Other 1 I 2. EPA Product Manager 3. Proposed Classification
PM< Dr. Sheryl Reilly 92 

## IX 

## I None 

# D Restricted 6. Expedited Review. In accordance with FIFRA Section 3(cX3) (b)(i), my product is similar or identical in composition and labeling to: EPA Reg. No. tName I 

### -II Final printed labels in response to Agency letter dated "Me Too" Application. Other
- Explain below.
: Use additional page(s) if necessary. (For section I and Section II.) ofBollgard and Bol!gard II cotton report entitled: "Susceptibility ofPink Bollwonn toB.t. Toxins CrylAc and Cry2Ab2 in 2007." I Child-Resistant Packaging 

# D Yes* 

## r;gJ No * Certification musf be submftted 

# " :!!l'!**~** Yes

# ~kag,"g wgt.

# ~o. p~r**~** Soluble Packaging 

## R7 Yes 

# :x No


## , Y'" Package wgt. 1 2

. CO' Metal Plastic Glass Paper Other 3. Location ofNet Contents InformaHon 4. Size(s) Retail Container flab,1I I On Label 

# o Label 

# o Container 0, Lab''''g; 6. Manner in Which Label isAffixed to Product Lithograph Paper glued

# ~""-"---------------------- I-IV
Name Title Russell P. Schneider, Ph.D. Director, Regulatory Affairs



# , I certify that the sta/emen/s I have made on Ihis form and all attachments thereto are true, accurate and complete.

# ~.

# -L 

# c. ;;;;:,/,ad',9"a.m"'I:a:::PU:'::::::::,:::::::::anager

4. Typ,d Nam,
.. Mehnda C. McCann (314) 694·7556 ,. uaw December 11, 2008 EPA Fonn 8570-1 (R'v. 3-94) • .1, y,lIow

### 04-CT-133E-47 and 04-CT-134E-47 

# .:.

.**..I;:'~** Area Code) (202)**3~3-2866**

# r.:.;
:. 10 • • •• .Received·•• : ••• (St
..**~)** 

### ••••• 

### •• 

### •••

# Memorandum Date: 

# I

# a. / 1;1 / ();t 

# To: ___ --"!3"-!.f-'-P=6

# -l..-{-'''l-=-d.:...J<---_, Regulatory Manager From: Information Services Branch, 

# ITRMD Your receipt ofthis data submission is not an indication that MRIDs for the enclosed studies have beenposted to OPPIN. 

# We expect that it will be approximately 5 days from the above date before the study-level data is available in OPPIN. Ifyou have any questions about this process, please contact Teresa Downs (305-5363).

. This is a:**~fully** 

# accepted submission 

# o partially accepted submission 

# o rejected submission /

# r~ {;I

# ~Jfr'

# f9¥ '. (pi'1T

# ~~uNITED STATES ENVIRONMENTAL PRO.**~CTION** AGENCY WASHINGTON, D.C. 20460



### December 15, 200S
MONSANTO COMPANY 1300 I STREET, NW, SUITE 450 EAST WASHINGTON, DC 20005 Report ofAnalysis for Compliance with PR Notice**86~5** OFFICE OF PREVENTION, PESTICIDES**At~D** TOXIC SUBSTANCES



### Thank)<lu for)<lur submittal of 12-DEC-OS. Our staffhas completed a preliminary analysis ofthe material. The results are provided as follows: Your submittal was found to be 

### in full compliance with the standards for submission of data contained in PRNotice 86-5. A copy ofyour bibliography is enclosed, annotated with Master Record ID's (MRIDs) assigned to each document submitted. Pleaseusethese numbers 

### in all future references to these documents. Thank: you for your cooperation. Ifyou have any questions concerningthis data submission, pleaseraise them with the cognizant Product Manager, to whom the data have been released.

# , November 10, 2008 Document Processirig Desk 

## MONSANTO 

## imagine

Office Q[PesticidePrograms (7504P) U.S. Environmental Protection Agency Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202-4501 M()NSMHO COMPANY 800 NORTH liNOSERGH BLVO 51 LOUIS, MISSOURI 63167**http://www.mons~mo.com**



### To: Dr. Sheryl Reilly, Biopesticide and Pollution Prevention Division Subject: Submission ofCry

### 1Acpinkbollwonn susceptibilitymonitoring method as part of the Bollgard® and Bollgan:l 

## If'cotton conditions ofregistrations (EPA Reg. Nos. 524-478 and 524-522, respectively). DearDr. Reilly: Monsanto representatives met withEPA onAugust 7,2008, and infonned EPA ofourintent 

### to measure pink

### bollworm (PBW) susceptibilitywith 

### a CrylAcmolecular method. Due to the 

### PBW Eradication Program, Monsanto expects 2008 and furore samplings will yield low collections from bolls. Sincethe current diagnostic dose methodrequires 100 PBWto create a population for testing, 

### it is likely that there will notbemanypopulations tested for 2008 and fuhlre collections. Anothermethod that has been developed for CrylAc uses molecular techniques to look for mutations 

### in genes that have beenpreviously_associated with**CrylAc-resis~ant** 

### PBW. Monsanto proposesto utilize this method for pheromone-trappedPBW from the 2008 and fuhlre collections. The CrylAcmolecularmethod would be employed in addition to the diagnostic dose method for the 2008 collections. In 

### the future, Monsanto will continue to evaluate the progress ofthe PBW Eradication Program andreport to EPA inthe event that no PBW are collected for a givenyear. Pleasefind enclosed copies ofthe following documents:
• Application for Pesticide (EPA Form 8570-1) • Protocol entitled: "2009 MonitoringPink Bollworm Susceptibilityto 

### B.t. Toxins" (one copy)



## , 

# ,
® Bollgard and Bollgard II are registered trademarks ofMonsanto

# Techn0~ 

# I 04HCT-133E-44 and04-CT-134EH 44J Page I of2 \

## ,~'p{2C

### c1?5 

# s

## NOV 1 S 2008 f'

## P>w 

# ''''CY\ : :, "te<1**,""'\J,~"** (,0\ "" D P 

# c" ,)), It

# {Ii 0" v

# 0 Registration opp tdentifier United States Number Environmental Protection Agency 

# 0 Amendment Washington, DC 20460 

## [8] Other Application for Pesticide - Section I 1. CompanytProduc! Number 2. EPA Product Manager 3. Proposed Classification

EPA Reg. Nos. 524-478 and 524-522 Dr. Sheryl Reilly CompanytProduct (Name) PM' 

## IX

## I None 

# D Restricted Bollgard@ and Bollgard

## n® Cotton 92 5. Name and Address ofApplicant (tndude ZIP Code) 6. Expedited Review. In accordance 'Nith FIFRA Section

Monsanto Company 3(c){3) (b)(i), my product is similar or identical in composition 800 North Lindbergh Blvd., and labeling to: Saint Louis, Missouri 63167 EPA Reg. No. 

# D Check jfth'IS is a new address Product Name 

### Section -II 

# 0 Amendment - Explain below. 

# 0 Final printed labels in response to Agency letterdated 

# 0 Resubmission in response to Agency letter dated 

# 0 "Me Too" Application. 

# 0 Notification
- Explain below. 

## [8] Other
- Explain below. Explanation: Use additional page(s) if necessary. (For section I and Section 11.) Submission of proposed method for pink bollwonn susceptibility monitoring in the Unites States required underthe Bollgard" and Bollgard II@ cotton conditions of re isirations. Section -III t. Material This Product Will Be Packa ed In: Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type ot Container DYes' DYes DYes 

# o Metal 

# o Plastic

### ~ No

### ~ No

### ~No 

# o Glass * Cerlmcatfon must It "Yes" No. per If "Yes" No. per 

### D Paper be submitted Unit Packaging wgt. Container Package wgt. Container [;g] Other 

## I(Specify) 3. Location of Net Contents Infonnation 4. 8ize(s) Retail Container 5. Location of Label Directions



### D Label 

### D Container 

### D On Label 

### D On Labeling accompanying product 6. Manner in Which Label is Affixed to Product 

# bd Lithograph [;g] Other 

### D Paper glued 

# o Stenciled 

### Section -IV 1. Contact Point Com lete items direct. below for identification ofindividual to be contacted, ifnecessa
. to rocess this a lication. Name Title Russell P. Schneider, Ph.D. Director, Washington, D.C. Telephone No. (tnctude Area Code) Regulatory Affairs (202) 383-2866
Certification 6. Date Applicalion I certify that the statements I have made on this form and all attachments thereto are frue, accurate and complete. Received I acknowledge that anyknowingly fatse ormisleading statement may bepunishable by fine orimprisonment or both underapplicable law. (Stamped) 

# HW%,iP

# ~C

# /J0~rn--- 3. Title Regulatory Affairs Manager, Cotton

4. yped Name 5. Date Melinda C. McCann (314) 694-7556 November 

### 10,2008



### .. EPA Form 8570·1 (Rev. 3-94) PrevIous editions are obsolete. . . White· EPA File Copy (ongmal) Yellow· Appltcant Copy 04-CT-133E-44 and 04-CT-134E-44

### 2009 Monitoring Pink Bollworm Susceptibility to

### B.t Toxins 

### OBJECTIVE Evaluate susceptibility offield-coIlected pink boIlworm to CrylAc and Cry2Ab2. 

### BACKGROUND Resistance ofpinkbollworm (PBW), Pectinophoragossypiella, to B.t. cotton would hamper control ofthis majorpest andjeopardize the success ofthe PBW eradication program now underway in the southwestern U.S. A group, led byDr. BruceTahashnik at the University of Arizona, will use bioassays and DNA screening to monitor pinkbollwonn resistance to B.t. toxins in 2009. As the PBW eradication program proceeds, itis becoming increasingly difficult to obtain PBW from the field, which will limit sample sizes for monitoring methods. It

### is expected that it will be especially difficult to obtain enough live PBW in the field in 2009 to establish strains for bioassays and thus the DNA screening for CrylAcwill be particularly important. At this time, there is no DNA screening method for Cry2Ab2. 

### BIOASSAYS Using established methods employed in Arizona since 1997 (Dennehy et aI., 2004), PBWfor bioassays will be collected from cotton fields in Arizona duringAugust to December 2009 bythe Arizona Cotton Research and Protection Council (ACRPC). At each location 300 to 2,000 bolls will be collected. Bolls will betaken to the UniversityofArizona in Tucson and putinboll boxes to obtain live PBWfor rearing on wheat genn diet (Dennehy et aI., 2004). For each strain derived from the field, susceptibilityto CrylAc and Cry2Ab2 will be determined using 21-day diet-incorporation bioassays from October 2009 to June 2010 at the University ofArizonausing established methods (Dennehy et 

### al., 2004, Tabashnik et al., 2000). As statedbefore, itis expected that the PBW eradication program will makecollections ofPBW from the field increasingly difficult; however, those collected will be analyzed. Attempts to culturein the laboratory strains established with less than 30 individuals are seldom successful. Nonetheless, attempts will bemade to establish laboratory strains whenever suitable infestations ofbolls are found inthefield. ForCrylAcbioassays, MVP-IfE' Bioinsecticide from DowAgroSciences will beused. For Cry2Ab2 bioassays, freeze-dried Cry2Ab2 com leafpowderfrom Monsanto will beused. Toxin will be added to liquid wheat genn diet to create 

### final concentrations of0 (untreated control), and I 0**~g** 

### toxin per ml diet for CrylAc and Cry2Ab2. Bioassays wiIl commence inthe FI generation and, ifnecessary to complete the desired number ofreplicates, will be continued through the Fs generation. Results obtained from replicate tests ofa strain will bepooled to obtain a single estimate ofmortaIityfor each concentration for that strain. The susceptible laboratory strain, APHIS-S, willbetested twice during the period inwhich CrylAc and Cry2Ab2 bioassays on2009 collections are conducted. APHIS":S hasbeentested each year since 1998 and serves as an internal standard for PBWbioassays. At least 200 larvae per strain willbe tested with each toxin with an additional 50 larvae per strain onuntreated diet (controls). IfPBW are difficult to obtain as expected, fewer larvae maybe tested per strain. Bioassay cups will be placed in

### plastic trays and incubated in darkness at 29±loC for 21 days, after which mortality and developmental stage ofsurvivors will be recorded. Live PBW developing to 4th instar, pupae or adults will be scored as live. Corrected mortality

04-CT-133E-44 and 04-CT-134E-44 Page Ion

### 2009 Monitoring PinkBollworm Susceptibility 

### to 

### B.t Toxins
will be computed using Abbott's fonnula. Ifany strain yields evidence ofdecreased 

### susceptibility to CrylAc orCry2Ab2, additional tests ofthat strain will be ccnducted. DNA SCREENING Using established methods (Tabashnik et aI., 2006), PBW for DNA screeningwill be obtained from field-sampled cotton bolls (as described above) and from pheromone traps. Personnel of the ACRPC will trap male PBW moths using commercially-available traps baited with PBW female sex pheromone lures. The field position ofeach pheromone trap will be identified using standard geopositioning methodology. Male moths will be removed from traps, preserved in 95% ,ethanol, and taken to the University ofArizona for DNA screening. 

### DNA screening will be conducted of500 field-collected PBW, with 50 PBW tested from each of 10 field sites. IfPBW are difficult to obtain as expected, the sample size per site, the number of sites represented, and the total sample size may be adjusted accordingly. DNA screening will be conducted using methods that have been employed in Arizona since 2001 (Tabashnik et al., 2006). Polymerase chain reaction (PCR) will be used to detect mutations in cadherin DNA 

### linked withresistance to CrylAc (Tabasbnik et al., 2006). STATISTICAL ANALYSES AND INTERPRETATION OFRESULTS CrylAcresistance allele frequency will be estimated from bioassays and DNA screening using 

### established statistical methods (Tabashnik et al., 2000, 2005a, 2006). Previous work demonstrated that PBW survival in bioassays at a diagnostic concentration of10 jlg CrylAcper ml 

### diet and on

### B.t. cotton producing CrylAc is tightly linked with three recessively-inherited 

### mutant alleles ofa cadherin-encoding gene (Morin et al., 2003, Tabasbnik et aI., 2005b). Atthe diagnostic concentration 

### ofCry

### lAc and 

### onB.t. cotton producing CrylAc, larvae with two of these resistance alleles in any combination survived, while those with one or none died. Because inheritance ofCrylAcresistance is recessive, bioassays detect only resistant homozygotes **(rr).** In 

### contrast, the DNA screening can detect resistant**alle~es** 

### in heterozygotes **(rs)** 

### and resistant homozygotes. Thus, DNA screening is much more effective for monitoring a low frequency of resistance associated with these cadherin mutations. However, the DNA screening can detect only the known cadherin alleles associated with CrylAcresistance, but bioassays can detect individuals with resistance to CrylAc or Cry2Ab2 caused by any mechanism. Together the bioassays and DNA screening provide a powerful monitoring approach. CrylAcresistance allele frequencies from statewide monitoring in Arizona from 2009 will be 

### contrasted statistically with baseline data from bioassays (Tabashnik et al., 2005a) and DNA screening (Tabashnik et al. 2006). The detailed genetic information required for estimating resistance allele frequency is not available for Cry2Ab2. For Cry2Ab2 data, statistical analyses will be conducted to compare the frequency ofsurvivors at the diagnostic concentration (10 jlg 

### toxin perml diet) between 2009 and previous years (Dermehy et aI., 2007). Criteria for responding to changes in the frequency 

### ofresistance detected inmonitoring were previously used for PBW susceptibilitymonitoring and submitted to EPA.



### 04-CT-133E-44 and 04-CT-134E-44 Page 2 oB

### 2009 Monitoring Pink Bollworm Susceptibility to 

### B.t Toxins 

### REFERENCES CITED 

### Dennehy, 

### T. J., 

### G. C. Unnithan, S. A. 

### Brink, B. D. Wood, Y Carriere, B. B. Tabashnik, L. 

### Antilla, and M. Whitlow. 2004. Update on PBW resistance to 

### B.t. cotton in the Southwest. Proc. 2004 Beltwide Cotton Conferences. 

### Dennehy, TJ., G.C.Unnithan, V. Harpold, Y Carriere, B.B. Tabashnik, L. 

### Antilla, and M. Whitlow. 2007. Susceptibility ofSouthwestern Pink Bollworm to 

### B.t. toxins CrylAc and Cry2Ab2 in 2005. Pages 105-126, Arizona Cotton Report (P-151), July 2007. University of Arizona Cooperative Extension. http://cals.arizona.edulpubs/crops/azI43

### 7/az14373a.pdf 

### Morin, S. R.,W. Biggs, M. S. Sisterson, L. 

### Shriver, C. Ellers-Kirk, D. Higginson, D. Holley, L. 

### J. Gahan, D. G. Heckel, Y Carriere, TJ. Dennehy, J. K. Brown, and B.B. Tabashnik 2003. Three cadherin alleles associated with resistance to 

### Bacillus thuringiensis in pink bollworm. Proc. Nat. 

### Acad. Sci.IOO: 5004-5009. Tabashnik, B. E., A. L. 

### Patin, T. J. Dennehy, Y-B. Liu, Y Carriere, M. Sims, and L. 

### Antilla. 2000. Frequency ofresistance to 

### Bacillus thuringiensis in field populations ofpinkbollworm. 

### Proc. NatL Acad. Sci. 97:12980-12984. Tabashnik, B. B., R. W. Biggs, D. M. Higginson, S. Henderson, D. C. Unnithan, G. C. Unnithan, C. Ellers-Kirk, M. S. Sisterson, T. J. 

### Dennehy, Y. Carriere, and S. Morin. 2005a. Association between resistance to 

### B.t. cotton and cadherin genotype 

### in pink bollworm. J. 

### Econ. Entomol. 98: 

### 635-644. Tabashnik, B. E., T. J. 

### DeIUlehy, and Y. Carriere. 2005b. Delayed resistance to 

### B.t. cotton in 

### pink bollworm. Proc. Nat'L Acad. Sci. USA 102: 15,389-15,393. Tabashnik, B.E., JA Fabrick, S. Henderson, RW. Biggs, C.M. Yafuso, M.B. Nyboer, N.M. Manbardt, LA Coughlin, J. Sollome, Y Carriere, T.J. Dennehy, and S. Morin. 2006. DNA screening reveals pink bollworm resistance to 

### B.t. cotton remains rare after a decade ofexposure. 

### J. 

### Econ. EntomoL 99: 1525-1530.

04-CT-133E-44 

### and 04-CT-134E-44 Page 3 of3**·~** 

# ..... •• !} 

# .**~** To: Cc: Bee: Jeannette MartinezlDC/USEPA/US Alan Reynolds/DC/USEPA/US, Subject: DPs 360499 and 360502: more! Hi, Jeannette! The two DPs cited above are for Monsanto's products**524~522** and 478 (BGlI and BG). They are PBW susceptibility monitoring data. My understanding is that they are with you for review (initially routed in Jan. '09 to Alan). Prior to the receipt ofthe above data, Monsanto submitted for both products a proposed new sampling method, necessary due to dwindling insect populations associated with the PBW eradication program. This info shouldhave accompaniedthe subject**bean~!** FYI, I will create beans routing the proposal to you today, and place the package on yourfile room shelf. With 

### my apologies for the oversight! See me with any questions or concerns, please. Thanks! DeniseUNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### RUSSELL P. SCHNEIDER MONSANTO CO MONSANTO COMPANY September 16, 

### 2008

1300 I 

### STREET, NW, SUITE

### 450 EAST WASHINGTON, DC 20005
PRODUCTNAME: BOLLGARD 

### II COTTON COMPANY NAME: MONSANTO COMPANY OPP IDENTIFICATION NUMBER: EPA FILE SYMBOL: 524·522 EPA RECEIPT DATE: 

### 09112/08 SUBJECT: RECEIPT OF AMENDMENT DEAR REGISTRANT: OFF!CEOF PREVENT!ON, PESTicIDES AND TOXIC SUBSTANCES



### The Office ofPesticide Programs has received your application for an amendment and it has passed an administrative screen for completeness. Duringthe initial screen we detennined that the application appears to qualify for fast track review. The packagewill now be forwarded to the Product Manager for review to determine its acceptability for fast track status. Ifyou have any questions, please contact Biologicals & PollutionPreventionDivision, PM Team 92, at (703) 305-6098. Sincerely, ,cJ

### .41M",-~ Front End Processing Staff Infonnation Services Branch Information Technology & Resources Management Division

# IFee for Servicel )f

# {835999xThis package includes the following for Division 

# () New Registration c) 

# AD**(~** 

# Amendment '.'!> 

# BPPD "RD u



# .'Studies?

.... Fee Waiver? 

# I I 

# @J

. ·volpay 

# % Reduction: I 

# Risk Mgr. Receipt No. 

# s-I 835999 

# I EPA File Symbol/Reg. No. 

# I 524-522 

# I Pin-Punch Date: 

# I 9/12/2008 

# I**~** 

# This item is NOT subject to FFS action.

ill 

## Inert Cleared for Intended Use Reviewer:

# ~om I

# JYlat VI 

## Remarks: 

# Parent/Child Decisions:

Uncleared Inert in Product Date: /5

# $?pI-'J.OOfS 

# I [ 

# I
,

I 

# I ! 

# I 

# I I

I 

# ISeptember 11, 2008 

### Document Processing Desk 

### MONSANTO 

## imagine

Office ofPesticide Programs (7504P) 

### U.S. Environmental Protection Agency Room**S~4900,** One PotomacYard 2777 South Crystal Drive Arlington, VA22202-4501 To: Dr. Sheryl Reilly, Biopesticide and Pollution Prevention Division MONSMHO COMPANY 800 NORTH**liNOBt~GH** BLVD ST. LO\!IS, M'SSOVR' 6,167 http://www.monsonto.com

SUbject: Submission oflabels reflecting a registration amendmentrequest for Bollgard 1I® cotton dated February 28, 2008 (EPA Reg. No. 524-522). Dear Dr. Reilly: On February 28, 2008, Monsanto submitted an amendment requestto the Bollgard II cotton registration, EPA Reg. No. 524-522, thatwould allow planting in 10 counties located in the Texas Panhandle. This submission contains the Bollgard II cotton product label reflecting the amendmentrequest and minor \vording changes. Attached arethe following:

.. Application for Pesticide Amendment (EPA Form**8570~I)** • Bollgard II cotton product label with changes highlighted (one copy)

.. Bollgard 11 cotton product label (one copy) Ifyou have any questions regarding this letter, please contact me directly at**314~694~**7556 or through Dr. Russ Schneider at**202~383-2866.** Sincerely,

# 4ut~ (I 

# /J!tcamMelinda C. McCann Cotton Regulatory Affairs Manager
cc: Denise Greenway Russell Schneider

® Bollgard II is a registered trademark ofMonsanto Technology LLC.
04-CT-133E-35 Page I of IPI"

..**~.d,** /row. OMS No. J E, Ii", 2-28-95

# ~ Registration opp Identifier 

# &EPA United States Number Environmental Protection Agency Amendment washington, DC 20460 

# 0 Other 

### Appli ,fori 1- 

### , I 1. Company/Product Numbel 2. EPA ProductManagel 3. Proposed Classification EPA Reg. No. Dr.

### She~l Reilly PM' 

# 00 None 

# D Restricted ! 11 cotton 90 5, Name and Address of Applicant (Include ZlP Code) 6. Expedited Review. In accoldance with FIFRA Section 3(c)(3) (b)(i). my

Monsanto Company product is similar or identical in composition and )"baling to: 800 North Lindbergh Blvd. EPA Reg. No. St. Louis, MO 63167 

# n Ch"k itllii, i, Product Name ·II 

### [RJ Amendment - Explain below. Final printed labels in response to 

## i= Agency letter dated 

# 18 Resubmission in lesponse to Agency It!tter dated 

### I::::: "Me Too" Application. Notification
- Explain below, 

# D other - Explain below. Explanation: Use additional page(s) ifnecessary. (For section Iand Section 11.) Submission oflabels reflecting registration amendment request for Bollgard:r:r® cotton dated February 28, 2008 (EPA Reg. No. 524- 

## !522) 1

## -..!!!. I Child-Resistant Packaging Unit Packaging Packaging 

# ,. i DYes' 

### DYes 

## = y" Metal DNO DNO**~** Plastic

_ No GO$ '" Certification must I 

## -:.e:" NO. P" 

# , 

# '"" No. poc Paper be submrtted Unit Packaging wgt. Package wgt. Other 3. Location ot Net Contents InformOltion 4. Size(s) Retail Container I



# o Label 

# o Container 

# := On Label 

## !00 lab,"" ' 6. Manner in Which Label isAffixed to Product**L~hograph** 

### U Other Po/per glued

# ~ IV i .. Title 

# I Code) DL !P. Affairs (202)
. 

# " i 6. Date Application I Clutifjt that the statements I have made on this form rmd therefo are true, accurate and**C()mple~.** Received I**ilcknOW/edg~-~~~t.~~~-knowingIYfa/se** ormfsJel/ding statementmaybe punishable byfine orimprisonmentor (Stamped)

# ~L -, {! V,'i-". !' 

# T", r.lf. 

# .1,
.**'A~** Regulatory Affairs Manager 

## ! 4

## T;:::;~~:C. McCann 

### I" 

## u"" TeL (314) 694-7556 September 11, 2008

04-CT-133E-35

### Active Ingredients: 

# Bollgard II® Cotton Bacillus thuringiensis subsp.

### kurstaki 

## Insect Control Protein

Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary for its production [PV-GHBKll] in event MON 15985 cotton .................................................... 0.003-0.009%* Bacillus thuringiensis CrylAcprotein and the genetic material necessary for its production [PV-GHBK04] in event MON 15985 cotton ....................................0.00004

- 0.00052%* 

### Other Ingredients: Substance producedby the marker genes and the genetic material necessary for theirproduction [PV-GHBK04 and PV-GHBKll] in event MON 15985 cotton.................. 0.0022-0.0304%* *Percentage (wtlwt) on a dry weight basis. PRECAUTIONARY STATEMENT Cf"UTJON KEEP OUT OF REACH OF CHILDREN CAUTION Net (Contents)
__ _ ® Bollgard II is a registered trademark ofMonsanto Technology LLC. EPA Registration Number 524-522 

### EPAEstablishmentNumber S24-MO-002
Monsanto Company 800 North Lindbergh Blvd. 

## st. Louis, Missouri 63167 DIRECTIONS FOR USE It is a violation offederal law to use this product in a manner inconsistent with its labeling. Cotton has been transfonned to express theBacillus thuringiensis subsp. kurstaki (B.t.k.) delta endotoxin CrylAc and Cry2Ab2 proteins for the control ofthe following lepidopteran cotton insect pests:

Page lof3Bollgard 11 cotton controls or suppresses the following cotton lepidopteran insectpests: Tobacco Budworm Pink Bollworm Cotton Bollworm Cabbage Looper Saltmarsh Caterpillar Cotton LeafPerforator Soybean Looper Beet Annyworm Fall Armyworm Yellowstriped Annyworm European Corn Borer 

### Heliothis virescens Pectinophoragossypiella Helicoverpa zea Trichoplusia ni Estigmene acrea Bucculatrix thurbeiella Pseudoplusia includens Spodoptera exigua Spodoptera frugiperda Spodoptera ornithogolli Ostrinia nubilalis Transformed cotton must be accompanied by the Grower Guide which contains the following: 1. The

### B.t.k delta endotoxin proteins expressed in this cotton control the above listed lepidopteran cotton insect pests. 2. Routine applications ofinsecticides to control these insects are usually unnecessary when cotton containing the 

### B. t.kdelta endotoxin proteins is are planted. 3. Instruction for growers to read the product Grower Guide prior to planting for information on planting, production and insect-resistance management. 4. Bollgard 11 must notbe planted nor sold for commercial planting in Hawaii, Puerto Rico, U.S. Virgin Islands, and south ofRoute 60 (near Tampa) in Florida, and in the following counties 

### in the Texas pcmhandle: Dallam, Sherman, Hansford, Ochiltree, Lipscomb, Hartley, Moore, Hutchinson, Roserts, and Carson. The following information regarding testplots and seed production must occur on bags of Bollgard 1I cotton seed intended for these purposes: a) Test plots orbreeding nurseries, regardless ofthe plot size, established in Hawaii must not be planted within 

### three 

### J miles of

### Gossypium tomentosum and must be surrounded by 24 border rows ofa suitable pollinator trap crop. b) Experimental plots and breeding nurseries ofBollgard 11 cotton are prohibited on the U.S. Virgin Islands, and c) Test plots orbreeding nurseries, regardless ofplot size, established on the island ofPuerto Rico may be established withoutrestriction ifinsecticide applications are used to effectively mitigate gene flow. Otherwise, established test plots orbreeding nurseries, regardless ofplot size, established onthe island ofPuerto Rico mustnotbeplanted within 

### three 

### J miles offeral cotton andmust be surrounded by 24 border rows ofa suitable pollinator trap crop.



### Page 2 of3

### The following infonnation regarding commercial production must be included in the Grower Guide: In 

### the states ofArizona, California, and New Mexico and in the following Texas counties: Brewster, Crane, Crockett, Culberson, EI Paso, Hudspeth, JeffDavis, Loving, Pecos, Presidio, Reeves, Terrell, Val Verde, Ward, and Winkler, all growers ofBollgard II cotton must employ one ofthe following structured refuge options: 

## 11 External, Unsprayed Refuge: Ensure that at least five**~** 

### acres**ofnon~B.t.k.** 

### cotton (refuge cotton) is planted for every 95 acres ofBollgard II cotton. The size ofthe refuge must be at least 150 feet wide, but preferably 300 feet wide. This refuge may notbe treated with sterile insects, pheromone, or any insecticide (except listedbelow) labeled for the control oftobacco budwonn, cotton bollwonn, orpink bollwonTI. At the pre-squaring cotton stage only, the refuge may be treated with any lepidopteran insecticide to control foliage feeding caterpillars. The refuge may be treated with acephate or methyl parathion at rates which will not control tobacco budwonn or the cotton bollwonn (equal to or less than 0.5 lbs. active ingredient per acre). The variety ofcotton planted in the refuge must be comparable to Bollgard II cotton, especially in the maturity date, and the refuge mustbemanaged (e.g., planting time, use offertilizer, weed control, irrigation, tennination, and management ofotherpests) similarly to Bollgard II cotton. Ensure that a non

### B.t.k. cotton refuge is maintained within at least Y2linear mile (preferably adjacent to or within 

### 'l4 mile or closer) from the Bollgard II cotton fields. 2) External Sprayed Refuge: Ensure that at least 20 acres ofnon-B.t.k. cotton are planted as a refuge for every 80 acres of Bollgard II cotton (total of 100 acres A). The variety ofcotton planted in the refuge must be comparable to BoIlgard II cotton, especially in the maturity date, and the refuge must be managed (e.g., planting time, use offertilizer, weed control, irrigation, tennination, and management ofother pests) similarly to Bollgard II cotton. The

### non-B.t.k. cotton may be treated with sterile insects, insecticides (excluding foliar 

### B.t.k. products) or pheromones labeled for control ofthe tobacco budworm, cotton bollworm, orpinkbollworm. Ensure that a 

### non-B.t.k. refuge is maintained within at least one

### 4- linear mile (preferably within 

### Y2 mile or closer) from the Bollgard II cotton fields. 3) Embedded Refuge: Plant the refuge cotton as at least one single 

### non-B.t.k. cotton row for every six 

### -6 to 10 rows of Bollgard II cotton. The refuge may be treated with sterile insects, any insecticide (excluding foliar 

### B.t.kproducts), orpheromone labeled for the control ofpinkbollwonn wheneverthe entire field is treated. The**in~field** 

### refuge rows may not be treated independently ofthe surrounding Bollgard II cotton field in which it is embedded. The refuge must be managed (fertilizer, weed control, etc.) identically to at

### the Bollgard II cotton.

Page 3 of3

### Active Ingredients: 

# Bollgard II® Cotton Bacillus thuringiensis subsp. kurstaki 

## Insect Control Protein

Bacillus thuringiensis Cry2Ab2 

### protein and the genetic material necessary for its production [PV-GHBK11] in eventMON 15985 cotton .................................................... 0.003-0.009%* 

### Bacillus thuringiensis CrylAcprotein and the genetic material necessary for its production [PV-GHBK04] in eventMON 15985 cotton ....................................0.00004

- 0.00052%* 

### Other Ingredients: Substance produced by the marker genes and the genetic material necessary for their production [PV-GHBK04 and PV-GHBK11] in event MON 15985 cotton.................. 0.0022-0.0304%* *Percentage (wt/\V1:) on a dry weight basis. PRECAUTIONARY STATEMENT KEEP OUT OFREACH OF CHILDREN CAUTION 

### Net (Contents)
___ _ ® Bollgard II is a registered trademark ofMonsanto Technology LLC.


### EPARegistration Number 524-522 EPA EstablishmentNumber S24-MO-002
Monsanto Company 800 North Lindbergh Blvd. St. Louis, Missouri 63167 DIRECTIONS FOR USE
It is a violation offederal law to use this product in a manner inconsistent with its labeling. Cotton has been transfonned to express the

### Bacillus thuringiensis subsp. 

### kurstaki (B.t.k.) delta endotoxin CrylAc and Cry2Ab2 proteins for the control ofthe following lepidopteran cotton insect pests:

Page I of3

### The following information regarding commercial production must be included in the Grower Guide: In the states ofArizona, California, and New Mexico and in the following Texas counties: Brewster, Crane, Crockett, Culberson, EI Paso, Hudspeth, JeffDavis, Loving, Pecos, Presidio, Reeves, Terrell, Val Verde, Ward, and Winkler, all growers ofBollgard II cotton must employ one ofthe following structured refuge options: 1) 

### External, Unsprayed Refuge: Ensure that at least five acres**ofnon~B.t.k.** 

### cotton (refuge cotton) is planted for every 95 acres of Bollgard II cotton. The size ofthe refuge must be at least 150 feet wide, but preferably 300 feet wide. This refuge may not be treated with sterile insects, pheromone, or any insecticide (except listed below) labeled for the control oftobacco budworm, cotton bollworm, orpink bollworm. At the pre-squaring cotton stage only, the refuge may be treated with any lepidopteran insecticide to control foliage feeding caterpillars. The refuge may be treated with acephate or methyl parathion at rates which will not control tobacco budworm orthe cotton bollworm (equal to or less than O.Slbs. active ingredient per acre). The variety ofcotton planted in the refuge must be comparable to Bollgard II cotton, especially inthe maturity date, and the refuge must be managed (e.g., planting time, use offertilizer, weed control, irrigation, tennination, and management ofother pests) similarly to Bollgard II cotton. Ensure that a 

### non-B.t.k. cotton refuge is maintained within at least 

### Yz linear mile (preferably adjacent to or within**~** 

### mile or closer) from the Bollgard II cotton fields. 2) External Sprayed Refuge: Ensure that at least 20 acres 

### ofnon-B.t.k. cotton are planted as a refuge for every 80 acres of Bollgard II cotton (total of 100 acres). The variety ofcottonplanted in the refuge must be comparable to Bollgard IIcotton, especially in the maturity date, and the refuge must be managed (e.g., planting time, use offertilizer, weed control, irrigation, termination, and management ofother pests) similarly to Bollgard II cotton. The 

### non-B.t.k. cotton may be treated with sterile insects, insecticides (excluding foliar

### B.t.k. products) or pheromones labeled for control ofthe tobacco budworm, cotton bollworm, orpink bollworm. Ensure that a 

### non-B.t.k. refuge is maintained within at least one linear mile (preferablY within 

### Y: mile or closer) from the Bollgard II cotton fields. 3) Embedded Refuge: Plant the refuge cotton as at least one single 

### non-B.t.k. cotton row for every six to 10 rowS of Bollgard II cotton. The refuge may be treated with sterile insects, any insecticide (excluding foliar 

### B.t.kproducts), orpheromone labeled for the control ofpink bollworm whenever the entire field is treated. The in-field refuge rows may notbe treated independently ofthe surrounding Bollgard II cotton field in which it is embedded. The refuge must be managed (fertilizer, weed control, etc.) identically to the Bollgard II cotton.

Page 3 of3

## MONSANTO 

# imasdne

June 27, 2008 Document Processing Desk Office ofPesticide Programs (7504P) 

### U.S. Environm-ental Protection Agency Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202-4501 "

To: Dr. Sheryl Reilly, Biopesticide and Pollution Prevention Division 474808-00

MONSANTO COMPANY 800 NORTH L'NOB<RGH BLVD ST. LOUIS, M'SSOVRI 63,67 http://www.monsanto.com

Subject: Submission ofthe 2007 CrylAc and Cry2Ab2 monitoring reports for Bollgard'$> and Bollgard**I~** cotton required as conditions ofregistrations (EPA Reg. Nos. 

### 524-478 and 524-522, respectively). Dear Dr. Reilly: As a Condition ofthe June 23,2006 and June 1,2007registrations for Bollgard and Bollgard II cotton, respectively, Monsanto is required to supply an annual monitoring report for 

### Heliothis virescens (tobacco budworm) and

### Helicoverpazea (cotton bollworm), reviewing the data from the previous growing season. Susceptibility to the CrylAc and CfY.2Ab2 proteins among field populations of 

### H zea collected during the 2007 cotton growing season was monitored in the United States by Dr. Ibrahim Ali and Dr. Randall G. Luttrell at the University ofArkansas in Fayetteville, AR. Dose-mortality responses were measured for 34 and 30 field populations exposed to CrylAc and Cry2Ab2, respectively. There is no evidence ofsignificant shifts in susceptibility of

### H zea as measured in larval mortality and stunting. Thereport swnmarizing this work is attached, fulfilling a condition ofregistration for both Bollgard and Bollgard II cotton. Susceptibility to the CrylAc and Cry2Ab2 proteins among field populations of 

### H virescens collected during the 2007 cotton growing season was monitored in the United States by Mr. Bruce Lang at Custom Bio-Products in Maxwell, IA. Ofthe 10 populations (CrylAc) and 11 populations (Cry2Ab2) of

### H virescens tested atthe 10 Ilg/ml diagnostic concentration, no larvae survived to the third instar. Therefore, H 

### virescens in 2007 produced no evidence ofreduced susceptibility to the

### B.t. toxins. CrylAc and Cry2Ab2. The reports summarizingthiswork are attached, fulfilling a condition ofregistration for both Bollgard and Bollgard II cotton. Additionally, Monsanto is required to submit, annually, any proposed changes to protocols for monitoring susceptibility of 

### H virescens, H zea, and

### Pectinophora

® Bollgard and Bollgard II are registered trademarks ofMonsanto Technology LLC. 04-CT-133E-43 and 04-CT-134E-43 Page 1 of3Dr. Sheryl Reilly Environmental Protection Agency June 27, 2008 Page 2 of3 gossypiella (pink bollwonn) to CrylAc and Cry2Ab2. Pursuant to that requirement, the proposed changes tothe protocols are summarized below: 1. The 2008 field collections ofH virescens and H zea will continue to be conducted as in previous years; however, rearing ofH zea will now be conducted at the Monsanto facility in Union City, TN. Once reared, H zeawill be shipped to the University ofArkansas for monitoring bioassays. Monsanto also proposes to include additional sampling in northwest Mississippi and northeast Arkansas to represent the Tennessee region.Rearing ofH virescens will continue to be conducted at Custom Bio-Products Ithas been increasingly difficultto sample H virescens and H zea for the past few seasons in Tennessee due to low populations inthe area.. Thus, Monsanto also included additional sampling in northwest Mississippi and northeastArkansas. These new locations should provide adequate numbers ofpopulations required for testing, while representing similar cropping regions to those found in Tennessee. 2. The 2008 H zea assay protocol, in cooperation with Dr. Ali and Dr. Luttrell at the University ofArkansas, will be conducted similarlyto previous years with standardized diagnostic concentrations for both CrylAc and Cry2Ab2. Additionally, the University ofArkansas will initiate method development studies to refine the process for populations that are not appropriately controlled atthe diagnostic concentrations. These studies will not be reported as they are still in method development. 3. The 2008 H virescens assay protocol, in cooperation with Custom Bio-Products (Maxwell, IA), will be conducted similarly to lastyear with standardized diagnostic concentrations for both CrylAc and Cry2Ab2. 4. The 2008 P. gossypiella monitoring protocol, in cooperation with the University ofArizona, will be conducted similarly to previous years with standardized diagnostic concentrations for both CrylAc and Cry2Ab2. However, the Principal Investigator will change from Dr. Tim Dennehyto Dr. BruceTabashnik and the field collections will be made by the Arizona Cotton Research & Protection Council. Finally, Monsanto is required to provide infonnation regarding any investigation of"less than expected results or control failures" for the target pests in Bollgard or Bollgard U cotton fields. In 2007, there were five reports ofH zea surviving in Bollgard II**cott~n** fields, one report ofH zea surviving in a Bollgard cotton field, and onereport of Spodoptera exigua surviving in a Bollgard II cotton field. Aftervisits to the fields and discussions with the fanners, it was detennined that none ofthe instancesrevealed any indication ofresistance.Dr. Sheryl Reilly Environmental Protection Agency June 27, 2008 Page 3 of3 

### Please fmd enclosed copies ofthe following documents:
• Transmittal document • Application for Pesticide (EPA Ponn 8570-1) • Volume I, report entitled: "MonitoringHelicoverpazea Susceptibility to CrylAc and Cry2Ab2 B.t. Toxins: Results of2007 Studies" (three copies) • Volume 2, report entitled: "Monitoring Susceptibility ofField Populations of Heliothis virescens toB.t. Toxin CrylAc: 2007 Collections and Assays" (three copies) • Volume 3, report entitled: "Monitoring Susceptibility ofField Population.!;i of Heliothis virescens to B.t. Toxin Cry2Ab2: 2007 Collections and Assays" (three copies) Please contact Dr. Russell Schneider at 202-383-2866 orme at 314-694-7556 ifyou have any questions regarding these reports. Sincerely,

Melinda C. McCann Cotton Regulatory Affairs Manager
cc: Denise Greenway Russell Schneider

04-CT-133E-43 and 04-CT-134E-43TRAl'lSMITTALDOCUMENT SUBMITTED BY Monsanto Company 800 North Lindbergh Blvd. SaintLouis, Missouri 63167

REGULATORY ACTION IN SUPPORT OF WmCH TillS PACKAGE IS SUBMITTED Submission ofthe 2007 CrylAc and Cry2Ab2 monitoring reports for Bollgard® and Bollgard

# rr® cottonrequired as conditions ofthe registrations EPA Reg. Nos. 524-478 and 524-522

TRANSMITTALDATE June 27, 2008
LIST OF SUBMITTED DOCUMENTS


### Volume 1: Ali, M.l., and R.G. Luttrell. 2008. Monitoring

### Helicoverpazea SusceptibilitY to CrylAc and Cry2Ab2

### B.t. Toxins: Results of2007 Studies. 04-CT-133E·43 and 04-CT-134E-43 Volume 1. Unpublished study prepared 

### by the University ofArkansas.

MRID Number
________ 4_7_4_80_8_0_1
___________ _ 

### Volume 2: 

### Lang, B. 2008. Monitoring Susceptibility ofFieldPopulations ofHeliothis virescens to 

### B.t. Toxin CrylAc: 2007 Collections and Assays. 04-CT133E-43 and 04-CT-134E-43 Volume 2. Unpublished studyprepared by CustomBio-Products.


### :MRID Number 47480802

® Bollgard and Bollgard II are registered trademarks ofMonsanto Technology LLC. 04-CT-133E-43 and 04-CT-134E-43 Page 1 of2

# 0 Registration opp Identifier 

# &EPA United States Number Environmental Protection Agency 

# 0 Amendment Washington, DC 20460 

## I2SJ Other ADollcatlon for Pesticide Section I 1. Company/Product Number 2. EPA Product Manager 3. Proposed Classification

EPA Reg. Nos. 524-478 and 524-522 Dr. Sheryl Reilly Company/Ploduct (Name) PM" 

## IR] None 

# D Restricted Bollgard® and Bollgard U® Cotton 

### 92 5. Name and Address ofApplicant (Include ZIP Code) 6. Expedited Review. In accordancewith FIFRA Section

Monsanto Company 3(c)(3) (b){f), my product is similar or identical in composition 800 North Lindbergh Blvd., and labeling to: 

### saInt Louis, Missouri _63167 EPA Reg. No. 

# D Check ifthis is a new address Product Name 

### Section -II 

# 0 Amendment - Explain below. 

# 0 Final printed labels in response to Agency letter dated 

# 0 Resubmission in response to Agency letter dated 

# 0 "Me Too" Application. 

# 0 Notification
- Explain betow. 

## I2SJ Other
- Explain below. Explanation: Use additional page(s) if necessary. (For section I and Section 11.) Submission of Boll ard and Boll ard II cotton H. virescens and H. zea susce tibilitY monitorinQ re orts in field o ulations collected durin 2007. Section

- III 1. Material This Product Will Be Pack ed In: Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type of Container DYes' DYes DYes 

### D Metal 

### D Plastic 

## [2J No [2J No [2JNO D Glass * Certification must II "Yes" No. per If "Yes" No. per 

### D Paper be submitted Unit Packaging wgt. Container Packagewgt. Container [8] Other 'Spe-;;ifvl 3. Location of Net Contents Information 4. Size{s) Retail Container 5. location of label Directions



### D label 

### D Container 

### D On Label 

### D On Labeling accompanyinQ product 6. Manner in Which label is Affixed to Product 

### D lithograph 

### D Paper glued [8] Other 

### D Stenciled 

### Section-IV 1. Contact Point Com ete items directt below foridentification ofindividuat 10 be contacted, ifnecessa ,to rocess this a /ication. 

## N=. ntle Russell P. Schneider, Ph.D. Director, Washington, D.C. Telephone No. (Include Area Code) Regulatory Affairs (202) 383-2866
Certification 6. Date Application t certify that the statements I have made on this form and all attachmenls thereto are true, accurate and complete. i'<:e..:eived I acknowledge thatanyknowingly false ormisleading stafement may be punishable by fine orimprisonment or (Stamped) both underapplicabli',/aw. 

# ''\.9"A,J,

# it. 

# f--' C. jJ(7/l 3. Title Regulatory Affairs Manager, COMa 4. Typed Name 5. Date Melinda C. McCann (314) 694-7556 June 27, 2008



# --- .. EPA Form 8570-1 (Rev. 3-94) PrevIous editions are obsolete

. 

### . . White - EPA File Copy (orrgmal) Yellow _Applicant Copy
04-CT-133E-43 and 04-CT-134E-43

### MONSANTO 473874·00



### . . 

## lmagme

MONs-uno COMMNY 

### March 28, 2008 Document Processing Desk Office ofPesticide Programs (7504P) U.S. Environmental Protection Agency 

### Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, 

### VA 22202-4501 To: Dr. Sheryl Reilly, Biopesticide and Pollution Prevention Division 800 NORTH LINDBERGH BLVD ST. LOUIs, M,SSOURI 6,U;7 http://www.monsanto.wm



### Subject: Submission ofgossypol and natural refuge modeling from three states, required condition ofBollgard 

## U® cotton registration (EPA Reg. No. 524-522). Dear 

### Dr. Reilly: 

### As a condition ofthe June 1, 2007 registration for Bollgard 

## n cotton, EPA required Monsanto to submit gossypol and natural refuge modeling data on tobacco budwonns collected from Alabama, Tennessee, and Central/Western Texas. To fulfill this condition, Monsanto is submitting the following:



### • Transmittal Document 

### • Application for Pesticide Amendment (EPA Form 8570-1) 

### • Volume 1 of 1: 

### Report entitled: "Contribution ofCotton Versus Non-Cotton Host Plants to Tobacco Budworm Populations in Alabama, Tennessee, and CentrallWestern Texas" (three copies) Please contact Dr. Russell Schneider at 202-383-2460, or me at 314-694-7556, ifyou have any questions regarding this request. Sincerely,

# ~C7"U~ Melinda 

### C. McCann Cotton Regulatory Affairs Manager
cc: Denise Greenway Russell Schneider

® Bollgard II is a registered trademark ofMonsanto Technology LLC. 04-CT- I33E-41 ,', ,

### TRANSMITTAL DOCUMENT
SUBMITTED BY Monsanto Company 800 NorthLindbergh Blvd. Saint Louis, Missouri 63167
REGULATORY ACTION 

### IN SUPPORT OFWHICH THIS PACKAGE IS SUBMITTED Submission ofgossypol and natural refuge modeling from three states, required condition ofBoUgard:u® cotton registration EPA Reg. No. 

### 524·522
TRANSMITTAL DATE March 28, 2008
LIST OF SUBMITTED DOCUMENTS
Volume 

### 1: Head, G. 2008. Contribution ofCotton Versus Non-Cotton HostPlants to Tobacco Budwonn Populations in Alabama, Tennessee, and CentrallWestem Texas. RPN-07-261. An unpublished study conducted byMonsanto 

### Company_ MRIDNumber 47387401



### COMPANY NAME: Monsanto Company
COMPANY OFFICIAL:

# ~ (7
.

# J-i~\':~'~ Melinda 

### C. McCann, Regulatory 

### Mfairs**Man~~~(:,**


### DATE: March 28, 2008
COMPANY CONTACT: Dr. Russell Schueider (202) 383·2866

® Bongard II is a registered trademark ofMonsanto Technology Ue. 04-CT-I33E-41

Page 1 of IFom>, I E, pi,,, 2-28-95 

# &EPA United States 

### Environmental Protection Agency Washington, DC 20460 Registration Amendment oppIdentifier Number Other I 

### for Section I

# ~,~._c_o_m_p_'~OY_'_P_'"_'_"ct_N_"**E9m~pb'~A'~' R~e~g**  ..

# ~**N0~.21 <0:±:,<~,.0~,.oL** _______ +-2_.

### _E_PA_P_'"_'l

# D"~'rt~.M~S'ih"~age~;:"'~;I~ Ro!!eill!l'.V
___ 

# --l13. Proposed Classification Company/Product (Name) PM # 

## IX 

## I 

# D IIIcotton 92 None Restricted 5. Name and Address of Applicant (Inctude ZtP Code)

Monsanto Company 800 North Lindbergh Blvd. I**~.** Louis, MO 63167 

### II 1 Ch"";tthi",,,

Amendment - Explain below. 6. Expedited Review. In accordance with FIFAA Section 3(c){3) (b)(i), my product is similar or identical in composition and labeling to: EPA Reg. No. _____________ _ Product Name _______________ _ I 

### -II 

### I I Final printed labels in response to**~** Agency letter dated 

# 18
Resubmission in response to Agency letter dated 

# D "Me Too" Application. 

# 10 Notification
- Explain below. 

## [8] Other
- Explain below.

Explanation: Use additional page{s) if necessary. (For section I and Section 11.)**Submissio~~!** 

### :=' J**r,-~-** 

### and natural refuge modeling from three states, required condition ofBollgard IT cotton I (lOY';

# Reg: "0. <0 <00' I i Child-Resistant Packaging 

# D Yes* 

### DNo**~ Certification**  **must be**  **submitted** 

# 13. location 01 Net Contents Inlormaflon



# D Label 

# D Container I Unit Packaging DYes 

# D No

6. Manner in Which Label is Affixed to Product

Name Russell P. Schneider I 

### -III
Water Soluble Packaging 

# Dy" DNo I ',,,: NO. poe Package wgt.
4. Size{s) Retail Container Metal Plastic Glass Paper 00" I 5.

. ot Label Directions lOOn Label !

# 0 00"'" lO'O'"oI**~** Lithograph ;= Paper glued Stenciled 

## U Other ______________ 

# -1**~~-IV.** ntle . -c'

I 1_"h:.Jr.:;:udeArea Code)

, (202) 383-2866**~** 3. ::>ate Application I certify that the statements I have made on this form and all attachments thereto are true, accurate and complete. H . d I acknowledge thai anyknowingly false ormisleading stalement maybepunishable byfine orimprisonment or I ecelve

# [2.,"9:bof~~"n,d~el'_'P:~~k/'"f-ffi_m~W~'~~~Yr:- ____________

# -r~""''-=-

# __=-____

# -=

______**----------------~I<stamped) ~** 

# ;J.L-

# :l**(f.;.J~** I" Iitle Regulatory Affairs Manager
4.

### T'M~ee~l'Nindamae c.- McCann Tel. (314) 694-7556 

## I" "". March 28, 2008

04-CT

-I33E-41UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D,C, 20460



### March 24, 2008

OPP Decision Number: D-391288 EPA File Symbol orRegistration Number: 524-522 Product Name: BOLLGARD II COTTON EPA Receipt Date: 03-Mar-2008 EPA Company Number: 524 CompanyName: MONSANTO COMPANY RUSSELL P, SCHNEIDER MONSANTO CO MONSANTO COMPANY 1300 I STREET, NW, SUITE 450 EAST WASHINGTON, DC 20005 OFF!CEOF PREVENT!ON; PESTICIDES AND TOXiC SUBSTANCES



### SUBJECT: Receipt ofRegistration Amendment Subject to Registration Service Fee DearRegistrant: The Office ofPesticide Programs has received your amendment and certification of payment. 

### Ifyou submitted data with this application, theresults ofthe PRN-86-5 screen 

### will be communicated separately. During the administrative screen, the Office ofPesticide Programs has determined that this Action is subject to a Pesticide Registration Service Fee as defined in the PesticideRegistration Improvement Act. The Action has been identified as Action Code: B900.0 AMENDMENT;PIP;NON-FAST-TRACK (EXCEPT B89 ABOVE); A refund ofyou $10,500 fee payment 

### will beprocessed as soon as is practicable. Ifyou have any questions, please contact the Pesticide Registration Service Fee Ombudsman at (703) 308-8260. Sincerely,

# ~u--Q&vu~ Front End Processing Staff InfonnationTechnology & 

### Resources Management Division

# ON HOLD

# /~&:cW.J2**cf>~**

# /:L 4 / 0 

## g 

# I;)**7..0U<'~ ~~**  

## Receipt: S- 

# /1.;2 5"

# '+7

# 7 File Symbol/Reg. 

## #: Bi 

# PiB'- ___ _

This PRJA action was rec'd after 

## 111/08 w/o 

## pre-payment.
Contacted registrant 

### to request that a copy ofthe h kJ
. fax or email. c ec pay.govreceIpt be sent to meby



### Notes: 

# 4/ Y-eu.£-

# '~7 c 

# /0JJUJ

# ~J.1,J**~ccc.L /!~** **~ ~** **~** W

# ~.**(UJ4~J;:<f** (u.ci:J.- 

# +Iv..**~.** 

# I'1 Tfi.J.J! 

# t.-v-c ,/0 

# VJWR..o 

# iYltr;JJ2J!. . , fVl

# a~ ,G'J"G{io

# 'i.i~, i5. ff2l!;

# c..:zr~

# 4**~ .-J~'/**  h-C'(

# L~ '"

# r~ w.d:L +-v:l. He

# Y~J W.

# ~**~** ce'**",;;L~.j.I.vv** 

## wfuv<-
.

# ~ ArJIR.,u

# -rl~ ..jJ';'" 

# w p f'jfl:.


### :3/

# i /0'6 !t-j,i**~**

# Ci-cy-- d''''/C8 [1,p.1

# .,~1:; 01"'- eMJ -,,<7"'-. ,**I~~** I:(
- 

# r-

### , 

# IFee for Servicel A

# {825478RThis package includes the following for Division



# .. New Registration :AD

•• Amendment ••: BPPD

, 

# :RD '" Stu9ies? Fee Waiver?

# ~ Risk Mgr. volpay % 

# Reduction: Receipt No. 

# s-I 825478 

# I EPA File Symbol/Reg. No. 1 

# 524-522 

# I Pin-Punch Date: 

# I 3/3/2008 1 

# D This item is NOT subject to FFS action

.



# . Acuun Ie; Requested: 1 

# B'1oo.ol Granted: 

# 16100.

# DI Amount Due: 

# $**~** 

# o Inert Cleared for Intended Use Reviewer: 

# AI"" Kz'{.-,oIJ:;;, Remarks: 

# ParenVChild Decisions: SeLo,,&o-c'( 

# -k ,vb",rss,c,,",- 

# +Or 52'i

- 'i7 '0

Uncleared Inert in Product

# Date:_'3"-/'i+!.::::.O~8__ , , 

# ,

I 

# , • 

## , 

# I

)Teresa, "SCHNEIDER, RUSSELL P IAGi1920]" <russeILp.schnelder@monsa nto.com> 03124/200812:19 PM

Per your request. Thanks, Russ To Teresa DownsJDC/USEPAfUS@EPA 

### ee bee Subject EPA Payment Confirmmation

This e-mal1 message may contain privileged and/orconfidential information, and is intended to be received onlybypersons entitled to receive such information. Ifyou have received this e-mail in error, please notify the senderimmediately. Please delete it and all attachments from anyservers, hard drives oranyothermedia. Otheruse ofthis e-mail byyou is strictly**prohibit~d.** All e-mails and attachments sent andreceived are subject to monitoring, reading and archival by Monsanto, including its subsidiaries. The recipient of this e-mail is solelyresponsible for checking for the presence of "Viruses" or other "Malware". Monsanto, along with its subsidiaries, accepts no liability for any damage caused byanysuch code transmitted byoraccompanying this e-mail oranyattachment.
-----. Message from <paygovadmln@mail.doc.twaLgov> on Mon, 24 Mar 2008 11 :11 :40 -0400 ----- 

### To: "LAIR, LARRY [AG/1000]" <larry.lair@monsanto.com> Subject: Pay.GoY Payment Confinnation THIS IS AN AUTOMATED MESSAGE. PLEASE DO NOT REPLY. Your transaction has been successfully completed. Payment Summary Application Name: PRIA Service Fees Pay.govTracking ID: 24UKGISR Agency Tracking ID: 74042591516 Account Holder Name: Russell P. Sclmeider Transaction Type: Sale Billing Address: 1300 I St. NW Billing Address 2: Suite 450 East City: Washington StatefProvince: DC ZiplPostal Code: 20005 Country: USA CardType: Master Card Card Number: ************3757 Expiration Date: Feb, 2009 Payment Amount $10,500.00 Transaction Date: Mar24, 200S II:I 1:40 AMDecision Number: Registration Number: 

## 5d if

.

### 4-- 7 

### 0:**~~~~~** Message from <paygovadmin@mail.doc.twaLgov> on Man, 24 Mar 2008 10:45:30**~0400 ~~~~­**  

### To: "LAIR, LARRY [AGIlOOO]" <lany.lair@monsanto.com> 

### Subject: Pay.Gov Payment Confinnation THIS IS AN AUTOMATED MESSAGE. PLEASE DO NOT REPLY. Yourtransaclion has been successfully completed. Payment Summary Application Name: PRlA Service Fees Pay.goy Tracking lD: 24UKGG3V Agency Tracking ID: 74042590151 Account Holder Name: Philip J. Eppard TransactionType: Sale BillingAddress: City: Creve Coeur StalelProvince: MO ZiplPostal Code: 63146 Country: USA Card Type: MasterCard Card Number: ************6810 Expiration Date: Feb, 2009 Payment Amount: S10,500.00 Transaction Dale: Mar24, 200810:45:30 AM Decision Number: Registration Number:

# &EPA United Slates 

### Environmental Protection Agency Washington, DC 20460 

### for 

# ,- . OMB No. 

# g Registration 

# 15**~::~dment** I 

### I opp Identifier Number

1. CompanytProduct Number EPA Reg. Nos. 2. EPA Product Manager Dc. Sh.;'" Reillv 3. Proposed Classif1cation land: 90 

## IX 

## I None 

# 0 Resfricted PM. I II cotton 5. Name and Address ofApplicant (Include ZIP Code)

Monsanto Company 6. Expedited Review. In accordance with FIFRASec\Jon 3(c)(3) (b)(i), my product is similaror identical in composition and labeling fo: 800 North Lindbergh Blvd. St. Louis, MO 63167 EPA Reg. No.
__________________________ __ 

# d' Check: jfthis is a new address 1- IIAmendment - Explain below. Resubmission in response to Agency letter dated Notification
- Explain below. Product Name



## = 

## =
Use additional page(s} if I and Section 11.) Final printed labels in response to Agency letter dated "Me Too· Application. Other
- Explain below. 

### Submission to amend the Bollgard and II cotton registrations to allow planting in 10 Texas panhandle ; (EPA Reg. Nos. 

# .-478 and <0' <00\ i i Packaging Yes' 

### F e... No • Cerirtrcation must be submrtted 

# "

3. Location ofNet Contents Intormation 

# D label 

# D Conta'mer**Un~** Packaging DYes DNo !fOCVes" Nn. per Unit Packaging wgt.**C~~lainer** I - 

### III
Water Soluble Packaging DYes DNo

4. Size(s) Retail Container 2. 

### ':iE,of' = Metal Plastic Glass Paper Other of Label i 

## F On Label On Ii 6, Manner in Which Label is Affixed to Product 

## F Lithograph 

## F Paper glued Slenciled**LJo~er** ____________________________ 

### --t

i**~::>,** D

..te Application 

# I**,.;s~[i"~n~i[~Y~.~'~t~th~'~~~~~~~~~:[h;i'~[O:~~'~'~d~':[[:'":'~';h:~~m~':th:.~ro~t:O~M~'~Iro~,:.~':=~rn:t:':'=od:'o:m :p:[:,[:.~.**  __________

# ~'I 

# r [ "koow[,dg'**~h'[,** Ofmi,["ding,[,[.m.ntm,yb.p",i,h,b'. byfloo**~**imp';""m,"'**~** '\ i 

# :JJ1r",,'rJ.y"

# (1.**~.** !3. Titl. R.gulatory AffaiD; M,nager 

## 4.**'Y~':** N,m. Melinda C. McCann Tel. (314) 694-7556 

## I" 

## D", February 28, 2008

04-CT-133E-35 and 04-CT-134E-35 

# ! r.&.;;eived (Stamped)February 28, 2008 Document Processing Desk 

### MONSANTO 

## 1m ine

Office ofPesticide Programs (7504P) U.s. Environmental Protection Agency Room S-4900, One Potomac Yard 

### 2777 South Crystal Drive Arlington, VA 22202-4501 To: Dr. Sheryl Reilly, Biopesticide and Pollution Prevention Division MONSANTO COMPANY ao(', NORTH LINDBERGH BLVD ST. LOUIs.**MIS~OUR,** 6)1117

Subject: Submission to amend the Bollgard® and Bollgard II® cotton registrations to allow planting in 10 Texas Panhandle counties (EPA Reg. Nos. 524-478 and 524-522). Dear Dr. Reilly: In 1997, the EPA identified southern growing regions acrosS the U.S. where

### Bacillus thuringiensis (Bt) corn and Btcotton were both grown, and detcnnined that in those areas Bt com would require a 50% corn refuge. In northern growing regions, where cotton was not grown, Bt com wouldrequire a 20% corn refuge. Prior to the 1998 growing season, Monsanto Company, in collaboration with the National Corn Growers Association and Texas Department ofAgriculture, petitioned the EPA to consider 10 counties located in the Texas Panhandle to be designated as requiring only a 20% corn refuge. The 10 counties were Carson, Dallam, Hansford, Hartley, Hutchinson, Lipscomb, Moore, Ochi1tree, Roberts, and Shennan. The EPA approved the request for reduced Btcorn refuge in these 10 Texas counties with the condition that the Bollgard and Bol1gard II cotton labels include a statementrestricting the commercial planting ofBt cotton in those counties. Since that time there has been increasing grower interest in Btcotton in those 10 Texas counties. Monsanto has evaluated the available data for the West Texas region, and specifically those 10 counties, and is proposing the Bollgard and Bollgard II cotton registrations be**a.~~~~~d** to allowing planting ofBollgard and Bollgard II cotton inthe 10 Texas counties, \7hib maintaining a 20%refuge requirement for Btcorn. Additionally, Monsanto requests that a Natural**Reft~g~** option be allowed for Bollgard II cotton in accordance with therefuge practices o"ithe: surrounding areas.

® Bo!lgard and Bollgard II are registered trademarks ofMonsanto Technology LLC.
04-CT-133E-35 and**04-CT-134E~35**Dr. Sheryl ReiHy Environmenta! Protection Agency February 28, 2008 Page 20f2

This submission contains the information available to support the proposed registration amendments. Attached are the following:

• Transmittal Document • Application for Pesticide Amendment (EPA Form 8570-1) • Volume I of 1: Report entitled: "Applicationto Allow Bollgard@andBollgardn® Cotton Use in the Texas Panhandle (Ten-County Region)" (three copies) lfyou have any questions regarding this letter, please contact me directly at 314-694-7556 or through Dr. Russ Schneider at 202-383-2866. Sincerely. '

# '_IUdt~~L (7
..

# U4:'tt;~ Melinda C. McCann Cotton Regulatory Affairs Manager
cc: Denise Greenway Russell Schneider

04-CT-133E-35 and 04-CT-134E-35TRANSMITTAL DOCUMENT
SUBMITTED BY Monsanto Company 

### 800 North Lindbergh Blvd. St Louis, Missouri 63167
REGULATORY ACTION IN SUPPORT OF WHICH THIS PACKAGE IS SUBMITTED Submission to amend the Bollgard@ and Bollgard U® cotton registrations to allow planting in 10 Texas Panhandle counties

EPAReg. Nos. 524-478 and 524-522
TRANSMITTAL DATE February 28,2008
LIST OF SUBMITTED DOCUMENTS Volume 1: Head, G. P. 2007. Application to Allow Bollgard® and Bollgard

## n® Cotton Use in the Texas Panhandle (Ten-County Region). RPN-07-260. An unpublished study conducted by Monsanto Company.


### MRIDNumber
COMPANY NAME: Monsanto Company 

## i/; 

# /(J Jr'A

## COMPANYOFFICIAL:L1~**.~** Melinda C. McCann, Regulatory Affairs**Man~~~~** 

### ._ DATE: February28, 2008
COMPANY CONTACT: Dr. Russell Schneider (202) 383-2866

® Bollgard and Bollgard II are registered trademarks ofMonsanto Technol,ogy LLC. 04-CT-133E-35 and 04-CT-134E-35 

### Page 1 ofI

# '!-**0~** 

# 10 0 

# th 

# ;, - 0 ,-)

# ~**Prp:J~~** JUL 2 2007

# ~

, \ i 

### , ,I (\P

# r~1 MONSANTO

# ~

June 27, 2007 Document Processing Desk Office ofPesticide Programs (7504P) U.S. Envirorunental Protection Agency Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202-4501 

### To: Dr. Sheryl Reilly, Biopesticide and Pollution Prevention Division 800 NORTK LINOS!;RGH BLVD S!_ Lou,s, M'SSOUR' 6;167 http://www.monsanto.com



### Subject: Submission ofrequested information on compliance assurance program for Bollgard® and Bollgard []® cotton (EPA Reg. Nos. 524-478 and 524-522). Dear Dr. Reilly: On June 20, 2007, Monsanto and EPArepresentatives met to discuss cotton compliance. During thatmeeting, EPA requested more information on refuge compliance than what Monsanto reported in its compliance assurance program report submittedJanuary 29, 2007 (MRID 47042701). This letter contains the requested information. Forthe 2006 telephone survey, Monsanto reported: While average Bongardpenetration was 77%, there was considerable variation around this average: • 37% ofgrowers planted 80% or less Bongard cotton • 33% ofgrowers plantedbetween 81 and 94% Bongard cotton • 9% ofgrowers planted 95% Bollgard cotton • 4% ofgrowers plantedbetween 96 and 99% BoUgard cotton • 17% ofgrowers planted 100% Bongard cotton (with the highest incidence in theWest with 23% ofthe growers)

® BoJJgard and Bollgard II are registered trademarks ofMonsanto Technology LLC.
Page 1of2 04-CT-133E-27 and 04-CT-J34E-27Dr. Sheryl Reilly Environmental Protection Agency June 27, 2007 Page 20f2 

### The information provided above is the average across regions. Below is a table reporting the average perregion.

Percent ofBOUgard Average Across North Region South Region West Region Cotton Acres Planted 

### Regions (%) (%) (%) (%)
- 

### 80 orless 

### 37 38 29 47 81 to 94 33 37 40 17 95 9 7 9 12 96 to 99 4 4 7 1 100 17 14 15 *23 *The results oftins survey may have mcluded growers III 

### the state ofAnzona who may beparticipating in the Pink Bollworm Eradication Program. Currently growers in the program are allowed to plant 100% Bollgard cotton under an Arizona Special Local Need registration. Please contact Dr. Russell Schneider at 202-383-2866 or me at 314-694-7556 ifyou have any questions regarding this submission.
. Sincerely,

Melinda C. McCann Cotton Regulatory Affairs Manager
cc: Alan Reynolds Russell Schneider

04-CT-133E-27 and 04-CT-134E-27