YALENT BIOSCIENCES. V C O R P O R A T I O N

810 TECHNOLOGY WAY

LIBERTYVILLE, IL 60048 USA - 800-323-9597

October 21, 2009

Sheryl Reilly, Ph.D

Biopesticides & Pollution Prevention Division

Document Processing Desk (REGFEE)

Olliee ofPesticide Programs (7504P)

U.S. Environmental Protection Agency

Room S-4900, One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202-4501

703-308-8269

RE: Foray® W G (VBC-60074) (EPA Reg. No. 73049-XXX) New product

registration

Dear Dr. Reilly:

Valent BioSciences Corporation is submitting the present package to support the

registration of the new product Foray® WG (VBC-60074) containing the active

ingredient Bacillus thuringiensis subs. kurstaki strain ABTS-351. We believe that this

submission qualifies as category B670-98, "New product, registered source of active

ingredient".

Studi es spec ific to this formulation are listed on the attached transmittal document. A

storage stability study for Foray WG is currently in progress. Final study report will be

submitted when available. An accelerated storages stability study is included in this

submission.

Present submission consists of:

• Application for Registration (EPA form 8570-1);

• Certification with Respect to Citation ofData (EPA form 8570-34);

• Data Matrix (EPA form 8570-35);

• Two (2) copies of Confidential Statement of Formula (EPA form 8570- ~)

• Copy ofthe pay.gov acknowledgement of payment;

• Material Safety Data Sheet for Foray WG;

• Three (3) copies ofthe supporting data;

Thiv Fsr and SFI cemfied paper cnntainv lory recvcled pm/"CO/II/lIIla " "<I\It',

478833000
• Transmittal Document;

• Five copies ofthe product label;

• CD including the electronic label;

• Certifi cation with respect to label integrity.

Please send us the DERs for the submitted studies when they become available. Please

contact me if you have any questions at 847-968-4724 or bye-mail at

doina.bujor@valent.com .

Sincerely,

t::7~ Regulatory Manager

Page 2
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TRANSMITTAL DOCUMENT

Submitter:

Valent BioSciences Corporation

870 Technology Way, Suite 100

Libertyville, IL 60048

Regulatory Action:

Application to register new product - Foray WG (VBC-60074)

Transmittal Date: October 21, 2009

List of Submitted studies:

Vol. MRID Guideline Study

1 OPPTS 885.1100 R.L Rowell, October 20, 2009, Method of Production OPPTS 885.1200

47893301 OPPTS 885 .1300 and Quality Control for VBG-BOO?4 (BacifJus

OPPTS 885.1500 lhuring iensis subsp. kurstakl), Report No. VBC-60074-

09

2 47893302 OPPTS 885.1400 SenSeong NG, October 29, 2008, Five Lot Analysis of

VBC-600 74 (Foray WG). Report No. VA-08 -002

3 47893303 OPPTS 885.1400 T. Marti n, October 5,2009, Bioburden Analysis of

Foray WG , VBC-60074. Report No. AAP01244

4 47883304 OPPTS 830.6317 A.L. Comb, August 5, 2009, VBC-60074: Accelerated

Storage Stability, Report No. ZAB/OO78

5 OPPTS 870.1100 J. Durando, November 8,2006, VBC-7400 : Acute

47893305 Oral Toxicity Up and Down Procedure in Rats, Report

No. 20339

6 OPPTS 870.1200 J. Durando, November 17, 2006, VBC-60074: Acute

47893308 Dermal Toxicity Study in Rats - Limit Test, Report No.

20340
Vol. MRID Guideline Study

7 47883307 OPPTS 870-1300 D.M. Sullivan. May 28, 2008, Acute Nose-only

Inhalation Toxicity Study of VBC-e0074 in Rats (Limit

Test), Report No. 2183

8 47893308 OPPTS 870-2400 J. Durando, November 17. 2006. VBC-60074: Primary

Eye Irritation in Rabbits , Report No. 20341

9 47893309 OPPTS 870.2500 J. Durando, November 20,2006, VBC-60074: Primary

Skin Irritation in Rabbits, Report No. 20342

10 OPPTS 870.2600 S. Dana Oley, September 16, 2008, VBC-60074:

47893310 Dermal Sensitization Study in Guinea Pigs (Buehler

Method - Nine Induction), Report No. 25453

11 OECD No. 213 C. Warmers, October 4,2007, Assessmen t of Side

47893311 OECD No. 214 Effects of VBC-e0074 to the Honey Bee, Apis

mefJifera l. in the l aboratory, Report No.

200614131S1-BLEU

A I , :C<:..-- ~---t/"(

Doina Bujor 7

Regulatory manager

Valent BioSciences Corporation

Phone: 847-968-4724

Fax: 925-948-3483

donia.bujor@valent.com