EPA Reg. No. 524-522

Vol. 3 
1
2

Memorandum 

Date: ') 10) I 0 'i 

To: __ ---'P'---iVt'--"1--I-2S1d-"'--__ , Regulatory Manager 

From: Information Services Branch, ITRMD 

Your receipt of this 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. 

If you have any questions about this process, 

please contact Teresa Downs (305-5363). 

This is a: 

~+ cot+cV". 

N' "''I, \." "\. <-€..-

~~'~) 

- So \1 jGcru\ 

- \~o \Ij ~rJ.It r(\qjl?JufcJ.. 7/'7fCfj 

jRfully accepted submission 

o partially accepted submission 

o rejected submission 
3

UNITED 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 of Analysis for Compliance with PR Notice 86-5 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Thank you for your submittal of30-JUN-09. Our staff has completed a preliminary 

analysis of the 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 PR Notice 86-5. A copy of your 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. If you have any 

questions concerning this data submission, please raise them with the cognizant Product 

Manager, to whom the data have been released. 
4

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" I X I None 0 Restricted 

Bollgard® and BoUgard u® Cotton 92 

5. Name and Address of Applicant (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 if this 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 letter dated 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 for identification of individuat fo be contacted, if necessa , 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 t have made on fhis form and af! attachments therefo are true, accurate and complete. Received I acknowledge thaf any knowingly false or misleading statement may be punishable by fine or imprisonment or (Stamped) both under applicable 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 PA Form 8570 -1 (Rev . 3-94 Previous editions are obsolete. White· EPA File Co py( on g inal Yellow-A pp licant Co py 
5

MONSANTO 

1m ine 

477913'()O 

June 29, 2009 Soo NORTH LIN08ERQH SlVO 

ST. LOUIS. M'SSOURI 6,,67 

http:.!/www.monsanto.com 

Document Processing Desk 

Office of Pesticide 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 

Subject: Submission of the 2008 CrylAc and Cry2Ah2 monitoring reports for Bollga.-d® 

and Bollgard I.r® cotton required as conditions of registrations (EPA Reg. Nos. 

524-478 and 524-522, respectively). 

Dear Dr. Reilly: 

As a condition of the June 23,2006 and June 1,2007 registrations 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 Pectinophora gossypiella (pink bollworm), including reviews of the data from the 

previous growing season. Herewith we report on the first two of these tlrree species. Per 

agreement with U.S. EPA, the report on P. gossypiella will be submitted by December 

15,2009. 

TIlls submission includes the following volumes: 

• Volume 1, report entitled: "Submission Summary": Results of 2008 

Studies 

.. Volume 2, report entitled: "Monitoring Helicoverpa zea Susceptibility 

to CrylAc and Cry2Ab B.t. Toxins: Results of2008 Studies" 

• Volume 3, report entitled: "Diet Overlay Bioassays with Cry2Ab 

Reduce Experiment-Wise Variation and Enhance Resistance 

Discrimination in Helicoverpa zea, Relative to Diet Incorporated 

Bioassays: Conclusions from Monitoring Resistance in the US in 

2008" 

• Volume 4, report entitled: ''Monitoring Helicoverpa zea 

Susceptibility to B.t. Toxins: Results of2008 Plant Assays" 

• Volume 5, report entitled: "Monitoring Susceptibility ofField 

Populations of Heliothis virescens to B.t. Toxin Cry1Ac: 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 and Bollgard II are registered trademarks of Monsanto Technology LLC. 

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

') 
6

Dr. Sheryl Reilly 

Environmental Protection Agency 

June 29, 2009 

Page 2 of4 

Volume 1 is a summary of all the reports that comprise this submission. Complete 

reports are being 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 of H zea collected in 'the U.S. during the 2008 cotton growing 

season. This monitoring was conducted by Dr. Ibrahim Ali and Dr. Randall G. Luttrell of 

the University of Arkansas in Fayetteville, AR. Both diet incorporation bioassays and 

diet overlay bioassays with the CrylAc protein showed no evidence of significant 

changes in susceptibility from 2007 to 2008. 

For Cry2Ab2, there were approximately 10% increases in 2008, relative to 2007, in 

percent of H zea larvae developing to or beyond 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 of practical significance, Monsanto undertook 

extensive additional studies to investigate these survivors of discriminating concentration 

bioassays (Volume 3). Volume 3 deals only with H zea, whileH virescens is reviewed 

in volumes 5 and 6. 

Volume 3 describes the results of diet-overlay and diet incorporation bioassays with 

Cry2Ab2 with H zea. The overlay method is advantageous because toxin is concentrated 

in a layer on top of the insect diet, through which insect must feed. In this manner, the 

diet overlay method increases the amount of toxin to which larvae are exposed and 

therein reduces LCx values. This makes it possible to establish the upper range of the 

mortality responses offield insects to Cry2Ab2, and to show that survivors of dietincorporation 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 of Arkansas (Ali and 

Luttrell), relating laboratory bioassay data to survival and development of H. zea fed 

conventional, Bollgard, Bollgard II, or WideStrike TM plant material. Results indicated 

that, while field and selected strains differed in survival on different plant types, survival 

to pupation was very low, reinforcing the conclusion that the field and selected strains did 

not possess major resistance genes. 

Volumes 5 and 6 describe evaluations of sixteen field strains of H. virescens, collected in 

2008, for susceptibility to CrylAc and Cry2Ab2, respectively. All were highly 

susceptible and unchanged from 2007. 

~ 

WideStrike is a registered trademark of Dow AgroSciences LLC. 

04-CT-133E-SO and 04-CT-134E-SO 
7

Dr. 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 monitoring programs. Pursuant to that requirement, we submit the 

following: 

I. Although the 2009 field collections of H. virescens and H zea will be made as in 

2008, after they are reared at the Monsanto facility in Union City, TN, bothH. zea 

and H virescens will be shipped to Custom Bio-Products (Maxell, IA) for 

monitoring bioassays, instead of being shipped to the University of Arkansas 

where the bioassays were conducted in the past. 

2. The 2009 H zea bioassay protocol, previously used by Dr. Ali and Dr. Luttrell at 

the University of Arkansas, will be utilized by Custom Bio-Products. Custom 

Bio-Products will conduct diet-incorporation assays similarly to previous years 

with standardized diagnostic concentrations for both CrylAc and Cry2Ab2. In 

addition, in 2009 and for future H. zea evaluations, the diet-overlay bioassay will 

be used. Diet-overlay bioassays for both CrylAc and Cry2Ab2 will be 

conducted, to provide bridging studies that will facilitate our future transition to 

diet overlay bioassays fur H zea. The rrotocol for the diet-overlay bioassay will 

be submitted to EPA by December 15' 2009. 

3. The 2009 P. gossypiella monitoring protocol contains no substantive changes 

from 2008. However, it should be noted that execution of this program may be 

negatively impacted by success of the pink bollwonn (PBW) eradication program, 

which may limit the population size available for collection. It may be 

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 in the protocols fur P. 

gossypiella monitoring) of moths caught in pheromone traps will be particularly 

important, since it will be very difficult to obtain field collections of live PBW 

due to the ongoing eradication program. 

Finally, Monsanto is required to provide information regarding any investigations of "less 

than expected results or control failures" for the target pests in Bollgard or Bollgard II 

cotton fields. In 2008, there was one report, in southeast Texas, of unusual survival of H. 

zea in a Bollgard cotton field. This complaint was investigated byDr. Jorge Cuarezma, 

Technical Development Representative of Monsanto. He determined that the damage 

caused by bollworms in the' field ofinterest was well within the expected limits for 

unsprayed Bollgard cotton. There were no other reports of unsatisfactory field 

perfonnance of Bollgard or Bollgard 1I in the U.S. in 2008. 

04-CT-133E-50 and 04-CT-134E-50 
8

Dr. Sheryl Reilly 

Environmental Protection Agency 

June 29, 2009 

Page4of4 

Please find enclosed copies' of the following documents: 

• Transmittal document 

• Application for Pesticide (EPA Fonn 8570-1) 

• Volume I, report entitled: "Submission Summary": Results of2008 

Studies 

• Volume 2, report entitled: "Monitoring Helicoverpa 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 in Helicoverpa zea, Relative to Diet Incorporated 

Bioassays: Conclusions from Monitoring Resistance in the US in 

2008" 

• Volume 4, report entitled: "Monitoring Helicoverpa zea 

Susceptibility to B.t. Toxins: Results of2008 Plant Assays" 

• Volume 5, report entitled: "Monitoring Susceptibility ofField 

Populations of He Ii at his virescens to B.t. Toxin CrylAc: 2008 

Collections and Assays" 

• Volume 6, report entitled: "Monitoring Susceptibility ofField 

Populations of Heliothis 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 regarding these 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 
9

TRANSMITTAL DOCUMENT 

SUBMITTED BY 

Monsanto Company 

800 North Lindbergh Blvd. 

Saint Louis, Missouri 63167 

REGULATORY ACTION IN SUPPORT OF WHICH THIS PACKAGE IS 

SUBMITTED 

Submission of the 2008 CrylAc and CryZAb2 monitoring reports for Bollgard® and 

Bollgard I.r® cotton required as conditions of the registrations 

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

TRANSMITTAL DATE 

June 29, 2009 

• Application for Pesticide (EPA Form 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-Wise Variation and Enhance Resistance 

Discrimination in Helicoverpa zea, Relative to Diet Incorporated 

Bioassays: Conclusions from Monitoring Resistance in the US in 

2008" 

• Volume 4, report entitled: "Monitoring Helicoverpa zea 

Susceptibility to 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 of Monsanto Technology LLC. 

04-CT-133E-50 and 04-CTT134E-50 

Page 1 of4 
10

LIST OF SUBMITTED 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 

Susceptibility to CrylAc and Cry2Ab2 B.t. Toxins: Results of2008 Studies. 

04-CT-133E-50 and 04-CT-134E-50 Volume 2. Unpublished study prepared 

by the University of Arkansas. 

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 in the 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. Monitoring Helicove1pa zea 

Susceptibility B.t Toxins: Results of2008 Plant Assays. 04-CT-133E-50 

and 04-CT-134E-50 Volume 4. Unpublished study prepared by the 

University of Arkansas. 

MRID Number __ 4_7_7_91_3_o_4 __________________ _ 

Volume 5: Lang, R 2008. Monitoring Susceptibility ofField Populations ofHeliothis 

virescens to B.t. Toxin CrylAc: 2008 Collections and Assays. 04-CT133E-50 and 04-CT-134E-50 Volume 5. Unpublished study prepared by 

Custom Bio-Products. 

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

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

Page 2 of4 
11

Volume 6: Lang, B. 2008. Monitoring Susceptibility ofField Populations of Heliothis 

virescens to B.t. Toxin Cry2Ab2: 2008 Collections and Assays. 04~CT133E-50 and 04-CT-134E-50 Volume 6. Unpublished study prepared 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 
12

COMPANY NAME: 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 

Page 4 of4 
13

Yes i.' No 

,"., 

FEB 10 Z009 
14

MONSANTO ~ 

January 29, 2009 

Document Processing Desk 

Office of Pesticide 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 of the 2008 Bollgard® and Bollgard II® cotton compliance 

assurance program report, required condition of registrations (EPA Reg. Nos. 

524-478 and 524-522). 

Dear Dr. Reilly: 

As a condition of the June 23, 2006 and September 16,2008 amended registrations for 

Bollgard and Bollgard II 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 in previous years, random cotton farmers were surveyed across the cotton growing 

regions of the U.S. In 2008, fanners that planted Bollgard II cotton in natural refuge 

areas or fanners that planted Bongard and/or Bongard II cotton and participated in the 

Pink Bollworm Eradication program were not included in the survey. Due to this 

exclusion, the number of qualified participants in the survey drastically decreased, as the 

majority of fanners contacted lived in natural refuge areas and chose to plant Bollgard II 

cotton. 

Please find enclosed copies of the 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 are regislered trademarks ofMonsanlo TechnolOgy LLC. 

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

Page I ofl 
15

Dr. 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 
16

TRANSMITTAL DOCUMENT 

SUBMITTED BY 

Monsanto Company 

800 North Lindbergh Blvd. 

St. Louis, MO 63167 

REGULATORY ACTION IN SUPPORT OF WHICH TIDS PACKAGE IS 

SUBMITTED 

Submission of the 2008 Bollgard® and Bollgard II® cotton compliance assurance 

program report, required condition of registrations (EPA Reg. Nos. 524-478 and 524-

522). 

TRANSMITTAL DATE 

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 Compliance Assurance 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:~ Melinda C. McCann 

. tJ~ Cotton Regulatory Affairs Manager 

DATE: January 29, 2009 

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

® Bollgard and Bollgard II are registeredlrademarks of Monsanto Technology LLC. 

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

Page lofl 
17

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON. D.C. 20460 

Februmy 4,2009 

MONSANTO COMPANY 

1300 I STREET, NW. SUITE 450 EAST 

WASHINGTON, DC 20005 

Report of Analysis for Compliance with PR Notice 86-5 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Thank you for your submittal of02-FEB-09. Our staff has completed a preliminmy 

analysis of the 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 PR Notice 86-5. A copy of your bibliography is 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. If you have any 

questions concerning this data submission, please raise them with the cognizant Product 

Manager, to whom the data have been released. 
18

Please read instructions on reverse before com lelina form. Form Approved. OMS No. 2070-0060. Approval EXpires 2-28-95 

D Registration OPP Identifier Number 

&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 and 524-522 Dr. SherYl Reillv 

4. CompanylProduct (Name) PM. lliJ None D Restricted 

Monsanto I Bollo-ard® and Bollgard U® cotton 92 

5. Name and Address of Applicant (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 if this 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) if necessary. (For section I and Section II.) 

Submission of the 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 of Container 

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 of Label 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 Paper glued 

[Rl Other 

o Stenciled 

Section IV 

1. Contact Point Complete ilems directl below for Identlficalion of individUal to be contacted, If necessa ,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 I have made on this form and all attachments thereto are true, accurate and comple/e. Received I acknowledge ~~bany knowingly false or misleading statemenl may be punishable by fine or imprisonment or (Stamped) both under a Ii bte law. 2t" tj~J;: ~(1 .U~ 3. Title 

Cotton Regulatory Affairs Manager 

4. Typed Name 5. Date 

Melinda C. McCann January 29,2009 

(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 
19

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 
20

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 of Pesticide 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 of Bollgard U® cotton seed units sold in the U.S. in 2008, 

required condition of registration (EPA Reg. No. 524-522). 

Dear Dr. Reilly: 

As a condition of the September 16, 2008 amended registration for Bollgard II cotton, 

EPA Reg. No. 524-522, EPA required that Monsanto submit an annual report on the 

number of units of Bollgard II cotton seed sold (shipped) and not returned, and an 

estimate of acres planted in the U.S. Furthermore, EPA required that Monsanto specify 

the number ofBollgard II cotton seed units sold to persons who have signed fanner 

license agreements. 

Please find enclosed copies of the 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 

of acres planted by state. However, Monsanto believes that this estimate is not an 

accurate representation of the actual number of acres planted in 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 planted per bag of cotton seed purchased (the estimated acreage planted 

was calculated using a conservative conversion factor of one unit sold per 4.2 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 of Monsanto Technology LLC. 

04-CT-133E-45 

Page lof2 

, " , 
21

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. 

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 r ( . 

vrwI;J/ (I ·lAl!ri~-- Melinda C. McCann 

Cotton Regulatory Affairs Manager 

cc: Denise Greenway 

Russell P. Schneider 

04-CT-133E-45 

• v, , 

". , , 
22

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 the U.S. in 2008, required condition 

of registration (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 report prepared 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 of Monsanto Technology LLC. 

04-CT-133E-45 

Page 1 of 1 

,.Co, ,,, __ .' (. , , c.'_·C.L- '-' 
23

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 of Analysis for Compliance with PR Notice 86-5 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Thank you for your submittal of 02-FEB-09. Our staff has completed a preliminary 

analysis of the 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 PR Notice 86-5. A copy of your bibliography is 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. If you have any 

questions concerning this data submission, please raise them with the cognizant Product 

Manager, to whom the data have been released. 
24

Memorandum 

Date: ~ / 07 / 0 9 

To: R P P D ('1 (}- ) , Regulatory Manager 

From: Information Services Branch, ITRMD 

Your receipt of this 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. 

If you have any questions about this process, 

please contact Teresa Downs (305-5363). 

This is a: ~fully accepted submission 

D partially accepted submission 

D rejected submission 
25

&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< 

I II cotton 92 

I i 

opp Identifier Number 

3. Proposed Crassifica~on 

[8J None 0 Restricted 

5. Name and Address of Applicanl (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: 

800 North 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 "Me Too" 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 of registration (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' or imprisonment or (St::1lllped) 

12'\'~A, I.-ft.' 'J. ~ .. 16,.A ____ . I" "" -1.\ . i l'A. j ~ j./1U ..... ~_ _ _ Cotton Regulatory Affairs Manager 

1

4

. Typ" N,m'Melinda C. McCann I'D'" January 29, 2009 I 

(314), ,< 

EPA Fo~ as?"" (R". "94, ' , I Copy 

04,CT-I33E-45 
26

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 Iiun /h rJ '*' ""-<t/c 'f Itel f1 .. ) 

fuIJ't 
27

December 11, 2008 

Document Processing Desk 

MONSANTO 

im"gine 

Office of Pesticide Programs (7504P) 

U.S. Environmental Protection Agency 

Room 5-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202-450 I 

To: Dr. Sheryl Reilly, Biopesticide and Pollution Control Division 

MONSANTO COMPANY 

8D~ NORTH LINDBERGH BLVO 

Sr. Lours, MISSO\)~I 6,r67 

http:;'1 www .nJDns~nlO_com 

Subject: Submission of report entitled "Susceptibility of Pink Bollworm to B.t. Toxins 

Cry lAc and Cry2Ab2 in 2007," a condition of the Bollgard® and Bollgard lI® 

cotton registrations (EPA Reg. Nos. 524-478 and 524-522). 

Dear Dr. Reilly: 

As a condition of the 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 of pink bollworm (Pectinophora 

gossypiella) susceptibility monitoring. The purpose of the monitoring is to assess potential 

emergence of insect resistance to Cry I Ac and Cry2Ab2 proteins. 

Enclosed is a report prepared by Dr. Bruce Tabashnik at The University of Arizona and 

colleagues at the Arizona Cotton Research and Protection Council, which fulfills this 

condition of the registrations. 

In 2007, a total of II strains of pink bollworm were collected from cotton fields in Arizona. 

California, and Texas. These strains were cultured in the laboratory and tested for 

susceptibility to Cry LA.c and Cry2Ab2 using diagnostic concentrations of 1.0 and 10 }lg 

protein/mL of diet. The report states that there is no indication of pink bollwonn resistance 

development to Cry lAc 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 

478224.00 
28

Dr. Sheryl Reilly 

U.S. Environmental Protection Agency. 

Please find enclosed copies of the following documents: 

• Transmittal document 

• Application for Pesticide (EPA Fonn 8570-1) 

December II, 2008 

Page 2 of2 

• Volume I of 1: Report entitled: "Susceptibility of Pink 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 if you 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 
29

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 of report entitled "Susceptibility of Pink Bollworm to B.t. Toxins Cry} Ac 

and Cry2Ab2 in 2007," a condition of the 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 of Pink 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 Melinda C. McCann, Regulatory {J. U~ Affairs Manager 

DATE: December 11, 2008 

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

® Bongard and Bollgard II are registered trademarks of Monsanto Technology LLC. 

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

Page 1 of 1 
30

United 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 and Address of Applicant (Include ZIP Code) 

Monsanto Company 

800 N. Lindbergh Blvd. 

St. Louis, MO 63167 

D Check it this 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 

I X 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 of Pink 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 of Net Contents InformaHon 4. Size(s) Retail Container flab,1I I 

On Label o Label o Container 0, Lab''''g; 

6. Manner in Which Label is Affixed 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,lIow04-CT-133E-47 and 04-CT-134E-47 

.:. 

. ..I;:'~ Area Code) 

(202) 3~3-2866 r.:.; 

:. 10 • • 

•• .Received· •• 

: ••• (St .. ~) 

••••• 

•• ••• 
31

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 of this 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. 

If you 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 ~~ 
32

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 of Analysis 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 staff has completed a preliminary 

analysis of the 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 PR Notice 86-5. A copy of your bibliography is 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. If you have any 

questions concerning this data submission, please raise them with the cognizant Product 

Manager, to whom the data have been released. 
33

, 

November 10, 2008 

Document Processirig Desk 

MONSANTO 

imagine 

Office Q[Pesticide Programs (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 of Cry 1 Ac pink bollwonn susceptibility monitoring method as part of 

the Bollgard® and Bollgan:l If' cotton conditions of registrations (EPA Reg. Nos. 

524-478 and 524-522, respectively). 

Dear Dr. Reilly: 

Monsanto representatives met with EPA on August 7,2008, and infonned EPA of our intent 

to measure pink bollworm (PBW) susceptibility with a CrylAc molecular method. Due to 

the PBW Eradication Program, Monsanto expects 2008 and furore samplings will yield low 

collections from bolls. Since the current diagnostic dose method requires 100 PBW to create 

a population for testing, it is likely that there will not be many populations tested for 2008 

and fuhlre collections. 

Another method that has been developed for CrylAc uses molecular techniques to look for 

mutations in genes that have been previously _associated with CrylAc-resis~ant PBW. 

Monsanto proposes to utilize this method for pheromone-trapped PBW from the 2008 and 

fuhlre collections. The CrylAc molecular method would be employed in addition to the 

diagnostic dose method for the 2008 collections. 

In the future, Monsanto will continue to evaluate the progress of the PBW Eradication 

Program and report to EPA in the event that no PBW are collected for a given year. 

Please find enclosed copies of the following documents: 

• Application for Pesticide (EPA Form 8570-1) 

• Protocol entitled: "2009 Monitoring Pink Bollworm Susceptibility to B.t. 

Toxins" (one copy) 

, 

, 

® Bollgard and Bollgard II are registered trademarks of Monsanto Techn0~ 

I 

04HCT-133E-44 and04-CT-134EH44J 

Page I of2 \ 

,~' p{2C c1?5 s 
34

NOV 1 S 2008 

f' P>w ''''CY\ 

: :, "te<1 ,""'\J,~" (,0\ "" D P c" ,)), It {Ii 0" 

v 
35

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' I X I None D Restricted 

Bollgard@ and Bollgard n® Cotton 92 

5. Name and Address of Applicant (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 jf th'IS 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 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 under the 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 of individual to be contacted, if necessa . 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 any knowingly fatse or misleading statement may be punishable by fine or imprisonment or 

both under applicable 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 
36

2009 Monitoring Pink Bollworm Susceptibility to B.t Toxins 

OBJECTIVE 

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

BACKGROUND 

Resistance of pink bollworm (PBW), Pectinophora gossypiella, to B.t. cotton would hamper 

control of this major pest and jeopardize the success of the PBW eradication program now 

underway in the southwestern U.S. A group, led by Dr. Bruce Tahashnik at the University of 

Arizona, will use bioassays and DNA screening to monitor pink bollwonn resistance to B.t. 

toxins in 2009. As the PBW eradication program proceeds, it is 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 CrylAc will 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), PBW for 

bioassays will be collected from cotton fields in Arizona during August to December 2009 by the 

Arizona Cotton Research and Protection Council (ACRPC). At each location 300 to 2,000 bolls 

will be collected. Bolls will be taken to the University of Arizona in Tucson and put in boll 

boxes to obtain live PBW for rearing on wheat genn diet (Dennehy et aI., 2004). For each strain 

derived from the field, susceptibility to CrylAc and Cry2Ab2 will be determined using 21-day 

diet-incorporation bioassays from October 2009 to June 2010 at the University of Arizona using 

established methods (Dennehy et al., 2004, Tabashnik et al., 2000). As stated before, it is 

expected that the PBW eradication program will make collections ofPBW from the field 

increasingly difficult; however, those collected will be analyzed. Attempts to culture in the 

laboratory strains established with less than 30 individuals are seldom successful. Nonetheless, 

attempts will be made to establish laboratory strains whenever suitable infestations of bolls are 

found in the field. 

For CrylAc bioassays, MVP-IfE' Bioinsecticide from Dow AgroSciences will be used. For 

Cry2Ab2 bioassays, freeze-dried Cry2Ab2 com leaf powder from Monsanto will be used. Toxin 

will be added to liquid wheat genn diet to create final concentrations of 0 (untreated control), 

and I 0 ~g toxin per ml diet for CrylAc and Cry2Ab2. Bioassays wiIl commence in the FI 

generation and, if necessary to complete the desired number of replicates, will be continued 

through the Fs generation. Results obtained from replicate tests of a strain will be pooled to 

obtain a single estimate ofmortaIity for each concentration for that strain. The susceptible 

laboratory strain, APHIS-S, will be tested twice during the period in which CrylAc and 

Cry2Ab2 bioassays on 2009 collections are conducted. APHIS":S has been tested each year since 

1998 and serves as an internal standard for PBW bioassays. 

At least 200 larvae per strain will be tested with each toxin with an additional 50 larvae per strain 

on untreated 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 of survivors 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 
37

2009 Monitoring Pink Bollworm Susceptibility to B.t Toxins 

will be computed using Abbott's fonnula. If any strain yields evidence of decreased 

susceptibility to CrylAc or Cry2Ab2, additional tests of that strain will be ccnducted. 

DNA SCREENING 

Using established methods (Tabashnik et aI., 2006), PBW for DNA screening will 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 of each 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 of Arizona for DNA screening. 

DNA screening will be conducted of 500 field-collected PBW, with 50 PBW tested from each of 

10 field sites. If PBW 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 with resistance to CrylAc (Tabasbnik et al., 2006). 

STATISTICAL ANALYSES AND INTERPRETATION OF RESULTS 

CrylAc resistance 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 of 10 jlg CrylAc per 

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). At the 

diagnostic concentration of Cry 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 of CrylAc resistance 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 CrylAc resistance, but bioassays can detect 

individuals with resistance to Cry lAc or Cry2Ab2 caused by any mechanism. Together the 

bioassays and DNA screening provide a powerful monitoring approach. 

CrylAc resistance 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 of survivors at the diagnostic concentration (10 jlg 

toxin per ml diet) between 2009 and previous years (Dermehy et aI., 2007). Criteria for 

responding to changes in the frequency of resistance detected in monitoring were previously 

used for PBW susceptibility monitoring and submitted to EPA. 

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

Page 2 oB 
38

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 of Southwestern 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/azI4 3 7/az 143 73a. 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 of resistance to Bacillus thuringiensis in field populations of pink bollworm. 

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 of exposure. 

J. Econ. EntomoL 99: 1525-1530. 

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

Page 3 of3 
39

·~ ..... •• !} . ~ 

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 of the 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 should have accompanied the subject bean~! 

FYI, I will create beans routing the proposal to you today, and place the package on your file room shelf. 

With my apologies for the oversight! 

See me with any questions or concerns, please. 

Thanks! 

Denise 
40
41

UNITED 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 

PRODUCT NAME: 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 of Pesticide Programs has received your application for an amendment and it 

has passed an administrative screen for completeness. 

During the initial screen we detennined that the application appears to qualify for fast 

track review. The package will now be forwarded to the Product Manager for review to 

determine its acceptability for fast track status. 

If you have any questions, please contact Biologicals & Pollution Prevention Division, 

PM Team 92, at (703) 305-6098. 

Sincerely, 

,cJ .41M",-~ Front End Processing Staff 

Infonnation Services Branch 

Information Technology & Resources Management Division 
42

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 

I 
43

September 11, 2008 

Document Processing Desk 

MONSANTO 

imagine 

Office of Pesticide 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 

MONSMHO COMPANY 

800 NORTH liNOBt~GH BLVD 

ST. LO\!IS, M'SSOVR' 6,167 

http://www.monsonto.com 

SUbject: Submission of labels reflecting a registration amendment request for Bollgard 1I® 

cotton dated February 28, 2008 (EPA Reg. No. 524-522). 

Dear Dr. Reilly: 

On February 28, 2008, Monsanto submitted an amendment request to the Bollgard II cotton 

registration, EPA Reg. No. 524-522, that would allow planting in 10 counties located in the 

Texas Panhandle. 

This submission contains the Bollgard II cotton product label reflecting the amendment request 

and minor \vording changes. Attached are the 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) 

If you 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 of Monsanto Technology LLC. 

04-CT-133E-35 

Page I of I 
44

PI" .. ~.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 Product Managel 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) if necessary. (For section I and Section 11.) 

Submission of labels 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 is Affixed 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 or mfsJel/ding statement may be punishable by fine or imprisonment or (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 
45

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 CrylAc protein and the genetic material necessary for its production 

[PV-GHBK04] in event MON 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-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 of Monsanto Technology LLC. 

EPA Registration Number 524-522 

EPA Establishment Number S24-MO-002 

Monsanto Company 

800 North Lindbergh Blvd. 

st. Louis, Missouri 63167 

DIRECTIONS FOR USE 

It is a violation of federal 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 of the following lepidopteran cotton insect 

pests: 

Page lof3 
46

Bollgard 11 cotton controls or suppresses the following cotton lepidopteran insect pests: 

Tobacco Budworm 

Pink Bollworm 

Cotton Bollworm 

Cabbage Looper 

Saltmarsh Caterpillar 

Cotton Leaf Perforator 

Soybean Looper 

Beet Annyworm 

Fall Armyworm 

Yellowstriped Annyworm 

European Corn Borer 

Heliothis virescens 

Pectinophora gossypiella 

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 of insecticides to control these insects are usually unnecessary when 

cotton containing the B. t.k delta 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 not be planted nor sold for commercial planting in Hawaii, Puerto Rico, 

U.S. Virgin Islands, and south of Route 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 test plots and seed production must occur on bags of 

Bollgard 1I cotton seed intended for these purposes: 

a) Test plots or breeding nurseries, regardless of the plot size, established in Hawaii must not be 

planted within three J miles of Gossypium tomentosum and must be surrounded by 24 border 

rows of a suitable pollinator trap crop. 

b) Experimental plots and breeding nurseries of Bollgard 11 cotton are prohibited on the U.S. Virgin 

Islands, and 

c) Test plots or breeding nurseries, regardless of plot size, established on the island of Puerto Rico 

may be established without restriction if insecticide applications are used to effectively mitigate 

gene flow. Otherwise, established test plots or breeding nurseries, regardless of plot size, 

established on the island of Puerto Rico must not be planted within three J miles of feral cotton 

and must be surrounded by 24 border rows of a suitable pollinator trap crop. 

Page 2 of3 
47

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

In the states of Arizona, California, and New Mexico and in the following Texas counties: 

Brewster, Crane, Crockett, Culberson, EI Paso, Hudspeth, Jeff Davis, Loving, Pecos, Presidio, 

Reeves, Terrell, Val Verde, Ward, and Winkler, all growers of Bollgard II cotton must employ one 

of the 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 

of Bollgard II cotton. The size of the 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 of tobacco budwonn, cotton bollwonn, or pink 

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 of cotton planted 

in the refuge must be comparable to Bollgard II cotton, especially in the maturity date, and the 

refuge must be managed (e.g., planting time, use of fertilizer, weed control, irrigation, 

tennination, and management of other pests) similarly to Bollgard II cotton. Ensure that a nonB.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 of cotton 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 of fertilizer, weed control, irrigation, tennination, and 

management of other 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 of the tobacco budworm, cotton bollworm, or pink bollworm. 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.k products), or pheromone labeled for the control of pink bollwonn whenever the entire 

field is treated. The in~field refuge rows may not be treated independently of the 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 
48

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 event MON 15985 cotton .................................................... 0.003-0.009%* 

Bacillus thuringiensis CrylAc protein and the genetic material necessary for its production 

[PV-GHBK04] in event MON 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 OF REACH OF CHILDREN 

CAUTION 

Net (Contents) ___ _ 

® Bollgard II is a registered trademark of Monsanto Technology LLC. 

EPA Registration Number 524-522 

EPA Establishment Number S24-MO-002 

Monsanto Company 

800 North Lindbergh Blvd. 

St. Louis, Missouri 63167 

DIRECTIONS FOR USE 

It is a violation of federal 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 Cry lAc and Cry2Ab2 proteins for the control of the following lepidopteran cotton insect 

pests: 

Page I of3 
49

The following information regarding commercial production must be included in the Grower Guide: 

In the states of Arizona, California, and New Mexico and in the following Texas counties: 

Brewster, Crane, Crockett, Culberson, EI Paso, Hudspeth, Jeff Davis, Loving, Pecos, Presidio, 

Reeves, Terrell, Val Verde, Ward, and Winkler, all growers of Bollgard II cotton must employ one 

of the 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 of the 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 of tobacco budworm, cotton bollworm, or pink 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 or the cotton bollworm (equal 

to or less than O.Slbs. active ingredient per acre). The variety of cotton planted in the refuge 

must be comparable to Bollgard II cotton, especially in the maturity date, and the refuge must be 

managed (e.g., planting time, use of fertilizer, weed control, irrigation, tennination, and 

management of other 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 of cotton planted in the refuge must be 

comparable to Bollgard II cotton, especially in the maturity date, and the refuge must be 

managed (e.g., planting time, use of fertilizer, weed control, irrigation, termination, and 

management of other 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 of the tobacco budworm, cotton bollworm, or pink 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.k products), or pheromone labeled for the control of pink bollworm whenever the entire 

field is treated. The in-field refuge rows may not be treated independently of the 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 
50
51

MONSANTO 

imasdne 

June 27, 2008 

Document Processing Desk 

Office of Pesticide 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 of the 2007 CrylAc and Cry2Ab2 monitoring reports for Bollgard'$> 

and Bollgard I~ cotton required as conditions of registrations (EPA Reg. Nos. 

524-478 and 524-522, respectively). 

Dear Dr. Reilly: 

As a Condition of the June 23,2006 and June 1,2007 registrations for Bollgard and 

Bollgard II cotton, respectively, Monsanto is required to supply an annual monitoring 

report for Heliothis virescens (tobacco budworm) and Helicoverpa zea (cotton 

bollworm), reviewing the data from the previous growing season. 

Susceptibility to the Cry lAc 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 of Arkansas in Fayetteville, 

AR. Dose-mortality responses were measured for 34 and 30 field populations exposed to 

Cry lAc and Cry2Ab2, respectively. There is no evidence of significant shifts in 

susceptibility of H zea as measured in larval mortality and stunting. The report 

swnmarizing this work is attached, fulfilling a condition of registration for both Bollgard 

and Bollgard II cotton. 

Susceptibility to the Cry lAc 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. Of the 10 

populations (Cry lAc) and 11 populations (Cry2Ab2) of H virescens tested at the 

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

virescens in 2007 produced no evidence of reduced susceptibility to the B.t. toxins. 

Cry lAc and Cry2Ab2. The reports summarizing this work are attached, fulfilling a 

condition of registration 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 of Monsanto Technology LLC. 

04-CT-133E-43 and 04-CT-134E-43 

Page 1 of3 
52

Dr. 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 to the protocols are summarized below: 

1. The 2008 field collections of H virescens and H zea will continue to be 

conducted as in previous years; however, rearing of H zea will now be conducted 

at the Monsanto facility in Union City, TN. Once reared, H zea will be shipped 

to the University of Arkansas for monitoring bioassays. Monsanto also proposes 

to include additional sampling in northwest Mississippi and northeast Arkansas to 

represent the Tennessee region.Rearing of H virescens will continue to be 

conducted at Custom Bio-Products It has been increasingly difficult to sample 

H virescens and H zea for the past few seasons in Tennessee due to low 

populations in the area .. Thus, Monsanto also included additional sampling in 

northwest Mississippi and northeast Arkansas. These new locations should 

provide adequate numbers of populations 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 of Arkansas, will be conducted similarly to previous years with 

standardized diagnostic concentrations for both Cry lAc and Cry2Ab2. 

Additionally, the University of Arkansas will initiate method development studies 

to refine the process for populations that are not appropriately controlled at the 

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 last year with standardized 

diagnostic concentrations for both CrylAc and Cry2Ab2. 

4. The 2008 P. gossypiella monitoring protocol, in cooperation with the University 

of Arizona, 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 Dennehy to Dr. Bruce Tabashnik 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 of H zea surviving in Bollgard II cott~n 

fields, one report of H zea surviving in a Bollgard cotton field, and one report of 

Spodoptera exigua surviving in a Bollgard II cotton field. After visits to the fields and 

discussions with the fanners, it was detennined that none of the instances revealed any 

indication of resistance. 
53

Dr. Sheryl Reilly 

Environmental Protection Agency 

June 27, 2008 

Page 3 of3 

Please fmd enclosed copies of the following documents: 

• Transmittal document 

• Application for Pesticide (EPA Ponn 8570-1) 

• Volume I, report entitled: "Monitoring Helicoverpa zea Susceptibility 

to CrylAc and Cry2Ab2 B.t. Toxins: Results of2007 Studies" (three 

copies) 

• Volume 2, report entitled: "Monitoring Susceptibility ofField 

Populations of Heliothis virescens to B.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 or me at 314-694-7556 if you 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-43 
54

TRAl'lSMITTAL DOCUMENT 

SUBMITTED BY 

Monsanto Company 

800 North Lindbergh Blvd. 

Saint Louis, Missouri 63167 

REGULATORY ACTION IN SUPPORT OF WmCH TillS PACKAGE IS 

SUBMITTED 

Submission of the 2007 CrylAc and Cry2Ab2 monitoring reports for Bollgard® and 

Bollgard rr® cotton required as conditions of the registrations 

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

TRANSMITTAL DATE 

June 27, 2008 

LIST OF SUBMITTED DOCUMENTS 

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

SusceptibilitY to Cry lAc and Cry2Ab2 B.t. Toxins: Results of 2007 Studies. 

04-CT-133E·43 and 04-CT-134E-43 Volume 1. Unpublished study prepared 

by the University of Arkansas. 

MRID Number ________ 4_7_4_80_8_0_1 ___________ _ 

Volume 2: Lang, B. 2008. Monitoring Susceptibility ofField Populations of Heliothis 

virescens to B.t. Toxin CrylAc: 2007 Collections and Assays. 04-CT133E-43 and 04-CT-134E-43 Volume 2. Unpublished study prepared by 

Custom Bio-Products. 

:MRID Number 47480802 

® Bollgard and Bollgard II are registered trademarks of Monsanto Technology LLC. 

04-CT-133E-43 and 04-CT-134E-43 

Page 1 of2 
55

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 of Applicant (Include ZIP Code) 6. Expedited Review. In accordance with 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 if this 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 for identification of individuat 10 be contacted, if necessa ,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 that any knowingly false or misleading stafement may be punishable by fine or imprisonment or (Stamped) both under applicabli',/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 
56
57

MONSANTO 

473874·00 

. . lmagme 

MONs-uno COMMNY 

March 28, 2008 

Document Processing Desk 

Office of Pesticide 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 of gossypol and natural refuge modeling from three states, required 

condition of Bollgard U® cotton registration (EPA Reg. No. 524-522). 

Dear Dr. Reilly: 

As a condition of the 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 of Cotton 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, if you 

have any questions regarding this request. 

Sincerely, 

~C7"U~ 

Melinda C. McCann 

Cotton Regulatory Affairs Manager 

cc: Denise Green way 

Russell Schneider 

® Bollgard II is a registered trademark of Monsanto Technology LLC. 

04-CT- I33E-41 

,', , 
58

TRANSMITTAL DOCUMENT 

SUBMITTED BY 

Monsanto Company 

800 North Lindbergh Blvd. 

Saint Louis, Missouri 63167 

REGULATORY ACTION IN SUPPORT OF WHICH THIS PACKAGE IS 

SUBMITTED 

Submission of gossypol and natural refuge modeling from three states, required condition 

of BoUgard:u® cotton registration 

EPA Reg. No. 524·522 

TRANSMITTAL DATE 

March 28, 2008 

LIST OF SUBMITTED DOCUMENTS 

Volume 1: Head, G. 2008. Contribution of Cotton Versus Non-Cotton Host Plants to 

Tobacco Budwonn Populations in Alabama, Tennessee, and CentrallWestem 

Texas. RPN-07-261. An unpublished study conducted by Monsanto 

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 of Monsanto Technology Ue. 

04-CT-I33E-41 

Page 1 of I 
59

Fom>, I E, pi,,, 2-28-95 

&EPA United States 

Environmental Protection Agency 

Washington, DC 20460 

Registration 

Amendment 

opp Identifier 

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 # I X I D 

I II cotton 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 of Bollgard 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 any knowingly false or misleading stalement may be punishable by fine or imprisonment 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" I itle Regulatory Affairs Manager 

4. T'M~ee~l'Nindamae c.- McCann Tel. (314) 694-7556 I" "". March 28, 2008 

04-CT -I33E-41 
60

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D,C, 20460 

March 24, 2008 

OPP Decision Number: D-391288 

EPA File Symbol or Registration Number: 524-522 

Product Name: BOLLGARD II COTTON 

EPA Receipt Date: 03-Mar-2008 

EPA Company Number: 524 

Company Name: 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 of Registration Amendment Subject to Registration Service Fee 

Dear Registrant: 

The Office of Pesticide Programs has received your amendment and certification of 

payment. If you submitted data with this application, the results of the PRN-86-5 screen will be 

communicated separately. During the administrative screen, the Office of Pesticide Programs 

has determined that this Action is subject to a Pesticide Registration Service Fee as defined in 

the Pesticide Registration Improvement Act. 

The Action has been identified as Action Code: B900.0 

AMENDMENT;PIP;NON-FAST-TRACK (EXCEPT B89 ABOVE); 

A refund of you $10,500 fee payment will be processed as soon as is practicable. 

If you have any questions, please contact the Pesticide Registration Service Fee Ombudsman at 

(703) 308-8260. 

Sincerely, 

~u--Q&vu~ 

Front End Processing Staff 

Infonnation Technology & Resources Management Division 
61

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 of the h kJ . fax or email. c ec pay.gov receIpt be sent to me by 

Notes: 4/ c 

Y-eu.£- '~7 

/0JJUJ ~J.1,J ~ccc.L /!~ ~ ~ ~ W ~. (UJ4~J;:<f (u.ci:J.- +Iv.. ~. I'1Tfi.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-
62

, 

IFee for Servicel 

A 

{825478RThis package includes the following for Division 

.. New Registration :AD 

•• Amendment •• : BPPD 

, :RD 

'" Stu9ies? Fee Waiver? 

volpay % Reduction: 

Risk Mgr. ~ 

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 

) 
63
64

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/or confidential information, and is intended to be 

received only by persons entitled to receive such information. If you have received this e-mail in error, 

please notify the sender immediately. Please delete it and all attachments from any servers, hard drives 

or any other media. Other use of this e-mail by you is strictly prohibit~d. 

All e-mails and attachments sent and received are subject to monitoring, reading and archival by 

Monsanto, including its subsidiaries. The recipient of this e-mail is solely responsible for checking for the 

presence of "Viruses" or other "Malware". Monsanto, along with its subsidiaries, accepts no liability for 

any damage caused by any such code transmitted by or accompanying this e-mail or any attachment. 

-----. 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 

Card Type: Master Card 

Card Number: ************3757 

Expiration Date: Feb, 2009 

Payment Amount $10,500.00 

Transaction Date: Mar 24, 200S II:I 1:40 AM 
65

Decision Number: 

Registration Number: 5 d if . 4-- 7 0: 

~~~~~ Message from <paygovadmin@mail.doc.twaLgov> on Man, 24 Mar 2008 1 0:45:30 ~0400 ~~~~­

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

Subject: Pay.Gov Payment Confinnation 

THIS IS AN AUTOMATED MESSAGE. PLEASE DO NOT REPLY. 

Your transaclion 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 

Transaction Type: Sale 

Billing Address: 

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: Mar 24, 200810:45:30 AM 

Decision Number: 

Registration Number: 

*Personal privacy information*
66

&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 

I X I None 0 Resfricted PM. 

I II cotton 

5. Name and Address of Applicant (Include ZIP Code) 

Monsanto Company 

6. Expedited Review. In accordance with FIFRASec\Jon 3(c)(3) (b)(i), my 

product is similar or 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-II 

Amendment - 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 of Net Contents Intormation 

D label D Conta'mer 

Un~ Packaging 

DYes 

DNo 

!f OCVes" 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 r [ ,.;s~[i"~n~i[~Y~.~'~t~th~'~~~~~~~~~:[h;i'~[O:~~'~'~d~':[[:'":'~';h:~~m~':th:.~ro~t:O~M~'~Iro~,:.~':=~rn:t:':'=od:'o:m "koow[,dg' ~h'[, Of mi,["ding ,[,[.m.nt m,y b. p",i,h,b'. by floo ~ imp';""m,"' :p:[:,[:.~. ~ __________ ~'I 

'\ 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) 
67

February 28, 2008 

Document Processing Desk 

MONSANTO 

1m ine 

Office of Pesticide 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 Bt cotton 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 would require a 20% corn refuge. Prior to the 1998 growing season, Monsanto 

Company, in collaboration with the National Corn Growers Association and Texas Department 

of Agriculture, 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 Bt corn refuge in these 10 Texas counties with the condition 

that the Bollgard and Bol1gard II cotton labels include a statement restricting the commercial 

planting of Bt cotton in those counties. 

Since that time there has been increasing grower interest in Bt cotton 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 in the 10 Texas counties, \7hib maintaining 

a 20% refuge requirement for Bt corn. Additionally, Monsanto requests that a Natural Reft~g~ 

option be allowed for Bollgard II cotton in accordance with the refuge practices o"ithe: 

surrounding areas. 

® Bo!lgard and Bollgard II are registered trademarks of Monsanto Technology LLC. 

04-CT-133E-35 and 04-CT-134E~35 
68

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: "Application to 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-35 
69

TRANSMITTAL 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 

EPA Reg. 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: February 28, 2008 

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

® Bollgard and Bollgard II are registered trademarks of Monsanto Technol,ogy LLC. 

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

Page 1 of I 
70

'!- 0~ 10 0 th 

;, - 0 

,-) ~ 

Prp:J~~ 

JUL 2 2007 

~ 

, \ i , ,I (\P 
71

r~1 MONSANTO ~ 

June 27, 2007 

Document Processing Desk 

Office of Pesticide 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 of requested 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 EPA representatives met to discuss cotton compliance. 

During that meeting, EPA requested more information on refuge compliance than what 

Monsanto reported in its compliance assurance program report submitted January 29, 

2007 (MRID 47042701). This letter contains the requested information. 

For the 2006 telephone survey, Monsanto reported: 

While average Bongard penetration was 77%, there was considerable variation 

around this average: 

• 37% of growers planted 80% or less Bongard cotton 

• 33% of growers planted between 81 and 94% Bongard cotton 

• 9% of growers planted 95% Bollgard cotton 

• 4% of growers planted between 96 and 99% BoUgard cotton 

• 17% of growers planted 100% Bongard cotton (with the highest incidence in 

the West with 23% of the growers) 

® BoJJgard and Bollgard II are registered trademarks of Monsanto Technology LLC. 

Page 1 of2 

04-CT-133E-27 and 04-CT-J34E-27 
72

Dr. 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 per region. 

Percent of BOUgard Average Across North Region South Region West Region 

Cotton Acres Planted Regions (%) (%) (%) (%) -

80 or less 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 of tins survey may have mcluded growers III the state of Anzona who may 

be participating 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 if you 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