EPA Registration 87829‐1
1

Materia I Sent for Data Extraction 

Reg # rr7'l:2'7 - I 

Description: ~~--t-Laiv) 

IZl Material(s) Sent to Data Extraction Contractors: 

New Stamped Label Dated !'c/I:>'!II 

D Notification Dated ____ _ 

,N New CSF(s) Dated 5/ 1'1/[/ 

D Other: _________ _ 

)2J Deci si 0 n #: __ 4_3--,-8'_'..=3,---· ::{--'--__ 

D Other Action/Comments: ________ _ 

Attach this coversheet to the top of the material or jacket. It 

must be well organized and clipped together, NOT STAPLED. 

Then give the material with this coversheet to staff in the 

Information Services Center (Room S-4900). 

Revi ewe r: __ -'-M-'-'-i'-'n=d.J-y--'O~n'_!.d=_i=s"_'h'__ ______ _ 

Phone: 703-605-0723 Division: RD/PM Team 25 

Date: __________ 0~!f_~~/_{_( ____________ __ 
2

U.S. ENVIRONMENTAL PROTECTION AGENCY 

Office of Pesticide Programs 

Registration Division (7505P) 

Ariel Rios Building 

1200 Pennsylvania Ave., NW 

Washington, D.C. 204130 

NOTICE OF PESTICIDE: 

...x.. Registration 

_ Reregistration 

(under FIFRA, as amended) 

i I 

EPA Registration 

Number: 

Date of Issuance: 

87829-1 

JUN 1 3 2011 

Term of Issuance: 

Name of Pesticide Product: 

Technical 

Willowood Propanil, 

1600 NW Garden Valley Blvd., Suite 130 

Roseburg, OR 97471 

c/o Wagner Regulatory Associates, Inc. 

. P.O. Box 640 

, Hockessin, DE 19707-0640 

On the baSis of information fUrnished by the registrant, the above nam"ed pesticide is hereby registeredfreregistered under the Federal Insecticide, 

Fungicide and Rodenticide Act. Registration is in no way to be construed as an endorsement or recommendation of this product by the Agency. In 

order to protect health and the environment, the Administrator, on his lJl~otion, may at any time suspend or cancel the registration of a pesticide in 

accordance with the Act. The acceptance of any name in connection wiJh the registration of a product under this Act is not to be construed as giving 

the registrant a right to exclusive use of the name or to its use if it has bii:en covered by others. 

This product is conditionally registered in accordance with FIFRA section 3(c)(7)(A) provided that you: 

1. Submit and/or cite all data required for registration review/reregistration of your product when the 

Agency requires all registrants of similar produc~s to submit data. 

2. Submit one-year Storage Stability (Guideline 830.6317) and Corrosion Characteristics (Guideline 

830.6320) studies within eighteen (18) months .from the date of this notice. 

3. Please note that only one batch was submitted for analysis (MRID 48501501). The remaining four 

batches are conditions of registration. Only the batch outlined within Agency review dated June 8, 2011 

(D390006) can be sold until the- remaining four ~atches are submitted and deemed acceptable. 

The Basic Confidential Statement of Formula (CSF)'dated May 19, 2011 is acceptable. 

A stamped copy of the label is enclosed for your records. Submit one (1) copy of the revised final printed 

label before you release the product for shipme':1t· Products shipped after eighteen (18) months from the 

date of this notice or the next printing of the label, Whichever occurs first, must bear the new revised label. 

If these conditions are not complied with, the regis:tlcltion will be subject to cancellation in accordance with 

FIFRA §6(e). Your release for shipment of the prqd.uct constitutes acceptance of these conditions. 

If you have any questions, please contact.Mindy Ol'1dish at (703)605-0723 or at ondish.mindy@epa.gov. 

Signature of Approving Official: )1' 1~' 

Product 

Kable Bo 

Manager 

Davis 

25 

~ 

\ = 

Date: 

,IUN 1 3 2011 

Herbicide Branch 

Division (7505P) 
3

87829-1-Vl-3MARll DRAFT EPA label- Initial Registration 

PropaniJ Technical 

Willowood Propanil Technical 

Active Ingredient: 

Propanil, N-(3,4-dichlorophenyl) propanamide ............................................. 98.5% 

Other Ingredients: .................................. : ..................................................... 1.5% 

Total ............................................................................................................ 100.00% 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

FIRST AID 

IF IN EYES • Hold eye open and rinse slowly with water for 15-20 minutes. 

• Remove contac,t. lenses, if present, after the first 5 minutes, 

then continue rinsing eye. . 

• Call a poison control center or doctor for treatment advice. 

IF • Call a poison control center or doctor immediately for treatment 

SWALLOWED advice. 

• Have person sip a glass of water if able to swallow. 

• Do not induce vomiting unless told to do so by a poison control 

center or doctor: 

• Do not give anyttiinQ by mouth to an unconscious person. 

IF INHALED • Move person to ff,esh air. 

• If person is not breathing, call 911 or an ambulance, then give 

artificial respiration, preferably mouth-to-mouth, if possible. 

• Call a poison control center or doctor for further treatment 

advice. 

IF ON SKIN • Take off contaminated clothing. 

OR • Rinse skin immediately with plenty of water for 15-20 minutes. 

CLOTHING • Call a poison cdntrol center or doctor for treatment advice. 

Have the product or container label with you when calling a poison control center or 

going in for treatment. 

For 24-hour medical emergency assistance (human or animal) call 1-800-222-1222. 

For chemical emergency assistance (spill, leak, fire, or accident) call ChemTrec at 1-

800-424-9300. 

EPA Reg. No. 87829-1 AOCEPTED 

EPA Est. No. 

Net Contents: 55 pounds (25 kilograms) JUN 13 2011 

ti'nda' 

~ 

tho Foda:ell'naedto!de, 

llnd 'ilnOO:!t1cbb ~ l an amended, fox> too ~ il!.t',:::' ~1"'2",\ - \ 
4

87829-1-Vl-3MARll DRAFT EPA label - Initial Registration 

Propanil Technical 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS 

Harmful if swallowed. Causes moderate eye irritation. Avoid contact with eyes or 

clothing. Wash hands before eating, drinKing, chewing gum, using tobacco, or using the 

toilet. 

ENVIRONMENTAL HAZARDS 

This pesticide is toxic to fish and aqQatic invertebrates. Do not discharge effluent 

containing this pesticide into lakes, stre'ams, ponds, estuaries, oceans or other public 

waters unless in accordance with the requirements of a National Pollutant Discharge 

Elimination System (NPDES) perm" and the permitting authority has been notified in 

writing prior to discharge. Do not discharge effluent containing this product to sewer 

systems without previously notifying the °local sewage treatment plant authority. Do not 

contaminate water when disposing of e-quipment was'hwaters. For guidance, contact 

your State Water Board or Regional Offic~' of the Environmental Protection Agency. 

DIRECTIONS FOR USE 

It is a violation of Federal Law to use 'iris product in a manner inconsistent with its 

labeling. . 

Only for formulation into an herbicide for t\1e following use: Rice 

This product may be used to formulate products for any additional use(s) not listed on 

the manufacturing-use product (MP) label if the formulator, user group, or grower has 

complied with the U.S. EPA submission requirements regarding support of such use(s). 

This product may be used for experimental purposes that are in compliance with U.S. 

EPA requirements. 

Formulators using the product are responsible for obtaining U.S. EPA registration for 

their formulated products. 

After December 1, 2011, the manufacturing use product may not be formulated into dry 

f10wable end-use products, unless they are packaged in closed systems or unless the 

Agency has changed the dry flowable mitigation based on submitted data. 
5

87829-1-Vl-3MARll DRAFT EPA Label-Initial Registration 

Propanil Technical 

STORAGE AND DISPOSAL 

Do not contaminate water, food or feed by storage, or disposal. 

PESTICIDE STORAGE: Open dumping is prohibited. Do not store this product near 

fertilizers, seeds, insecticides, or fungicides. Do not store near heat or open flame. 

Containers should not be stacked more than 3 units high. Reclose all partially used 

containers by tying bag top shut. Damaged or leaking containers, which contain 

product, that cannot be used immediately should be transferred to suitable sound 

containers and property marked. Any spilled material should be thoroughly swept up 

and transferred to the new container or disposed of as indicated under "Pesticide 

Disposal". 

PESTICIDE DISPOSAL: Pesticide wasles are toxic. Improper disposal of excess 

pesticide, spray mixture, or rinsate is a viqlation of Federal Law. If these wastes cannot 

be disposed of by use according to label instructions, contact your State Pesticide or 

Environmental Control Agency, or the Hazardous Waste representative at the nearest 

EPA Regional Office for guidance. 

CONTAINER DISPOSAL: 

Nonrefillable container: Do not reuse ~or refill this container. Offer for recycling, if 

available. Clean container promptly after emptying. Completely empty liner by shaking 

and tapping sides and bottom to loosen clinging particles. Empty residue into suitable 

container. Then dispose of liner in a sanitary landfill or by incineration if allowed by state 

and local authorities. If container is contaminated and cannot be reused, dispose of in 

the same manner. 

STEPS TO BE TAKEN IN CASE MATERIAL IS RELEASED OR SPILLED: Scoop or 

shovel solid material into a suitable cpntainer for recovery or disposal. Remove 

contaminated clothing promptly and wash exposed skin areas with soap and water. 

Wash clothing before reuse. Keep spill out of sewers and open bodies of water. Refer to 

PRECAUTIONARY STATEMENTS. 

IMPORTANT: READ BEFORE USE 

Read the entire Directions for Use, Conditions, Disclaimer of Warranties and Limitations 

of Liability before using this product. If terms· are not acceptable, return the unopened 

product container at once. 

By using this product, user or buyer accepts the following Conditions, Disclaimer of 

Warranties and Limitations of Liability. 

CONDITIONS: The directions for use of this product are believed to be adequate and 

must be followed carefully. 

However, it is impossible to eliminate all risks associated with the use of this product. 

Crop injury, ineffectiveness or other unintended con.sequences may result because of 

such factors as weather conditions, presence of other materials, or the manner of use or 

application, all of which are beyond the control of Willowood USA LLC. To the extent 

consistent with applicable law, all such risks shall be assumed by the user or buyer. 

DISCLAIMER OF WARRANTIES: TO THE EXTENT CONSISTENT WITH 

APPLICABLE LAW, WILLOWOOD USA LLC MAKES NO OTHER WARRANTIES, 

EXPRESS OR IMPLIED, OF MERCHANTABILITY OR OF FITNESS FOR A 
6

87829-1-Vl-3MARll DRAFT EPA Label -Initial Registration 

PropanJI Technical 

PARTICULAR PURPOSE OR OTHERWISE, THAT EXTEND BEYOND THE 

STATEMENTS MADE ON THIS LABEL. To the extent consistent with applicable law, 

no agent of Willowood USA LLC is authorized to make any warranties beyond those 

contained herein or to modify the warranties contained herein. TO THE EXTENT 

CONSISTENT WITH APPLICABLE LAW, WILLOWOOD USA LLC DISCLAIMS ANY 

LIABILITY WHATSOEVER FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL 

DAMAGES RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT. 

LIMITATIONS OF LIABILITY: TO THE' EXTENT CONSISTENT WITH APPLICABLE 

LAW, THE EXCLUSIVE REMEDY OF THE USER OR BUYER FOR ANY AND ALL 

LOSSES, INJURIES OR DAMAGES RESULTING FROM THE USE OR HANDLING OF 

THIS PRODUCT, WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, 

STRICT LIABILITY OR OTHERWISE, SHALL NOT EXCEED THE PURCHASE PRICE 

PAID, OR AT WILLOWOOD USA LLC'S ELECTION, THE REPLACEMENT OF 

PRODUCT. 

Manufactured for: 

Willowood Propanil, LLC 

1600 NW Garden Valley Blvd. Suite 130 

Roseburg, OR 97471 
7

\ 

REGISTRATION NOTE FOR RECORD 

EPA Reg. No.1 File Symbol: 87829-R (1) 

Product Name: Willowood Propanil Technical 

Application Date: 8/13/10 

Action Description: R310 

PRODUCT CHEMISTRY: (OP382829; 2/1/11 & OP390006; 6/8/11) 

Revised basic CSF 5/19/11 

Submitted own product chemistry studies (MRIO 48197601-05) 

HED impurities review determined product was not substantially similar to Reg# 71085-28 

RO agreed to review one-batch analysis of revised formulation reducing amount of 

impurities of concern . 

Data Gaps: Storage Stability & Corrosion Characteristics 

Remaining 4~batch analysis' 

ACUTE TOXICITY: (OP382830; 1/21/11) 

Substantially similar to Reg# 71085-28 

Cite-all method for acute tox data support 

Review noted that no tox review was found for the cited product. however a 6/29/07 

review was found in the PRO database with the following tox categories: 

Tox Category III for Acute Oral & Primary Eye Irritation 

Tox Category IV/Negative for all other routes of exposure 

GENERIC DATA: . 

Cite-all method of generic data support ...... 

LABEL REVIEW: 

Propanil technical, label comments sent·vja email, revised label submitted 

COMMENTS: 

Revised offer to pay letter to address petition to deny registration by propanil task force 

Subsequent disputes with task force settled according to OGC 

DECISION: 

Conditional registration with data requirements 

Reviewer: I Mindy Ondish I Date: I 6/13/11 
8

'\ 

BARCODE: D390006; Reg. No./FILt:" SYMBOL No.: 87829-R; PRODUCT: WilloV'ilQod Propanil Technical 

Date: 

SUBJECT: 

FROM: 

TO: 

June 8,2011 

FEE. Product Chemistry Review ofWiliowood Propanil Technical TGAJlMUP 

Shyam Mathur 

Product Chemistry Team Leader 

Technical Review Branch/RD (7505P) 

Mindy Ondish I Kable Davis, RM 23 

Herbicide Branch I RD (7505P) 

DP BARCODE: 0390006 

DECISION No.: 438732 

Registration Number I File Symbol No.: 87829-R. 

PRODUCT NAME: Willowood Propanil Technical 

PCC: 028201 

REGISTRANT: Willowood Propanil, LLC 

USE: Herbicide 

FOOD USE: YeS [XI No [ I 

MRID Numbers: 485015-01 

INTRODUCTION 

The Product chemistry review on the WilJowood Propanil Technical was conducted by TRB on February 

1, 2011 (see product chemistry review with DP382829, MRID Nos. 481976-01 to 481976-05). In this 

application, the registrant has also claimed that the proposed product is substantially similar to the 

registered product with Reg. No. 71085-28. It was concluded that all the product chemistry data submitted 

was acceptable (including basic CSF dated 8-13-10), except for the guidelines 830.6317 (one year 

storage stability) and 830.6320 (corrosion characteristics). The similarity decision was deferred, since the 

proposed product contained two new impurities oftox concern which are not listed in the CSF of the cited 

product. The registrant was asked to reduce the amounts of these impurities below or equal to EPA 

maximum permisSible limits and submit at least one batch analysis on the proposed product along with a 

revised representative basic CSF. The registrant o"n May 20, 2011 submitted a revised basic CSF (dated 

05-19-11) and the supporting one batch analysis for the proposed product. TRB has been asked to 

determine the acceptability of the data submitted and the proposed basic CSF. 

SUMMARY OF FINDINGS 

1. The registrant has submitted a Confidential Statement of Formula for a basic formulation (dated 5-19-

11) of Willowood Propanil Technical. The proposed nominal concentration of the active ingredient is 

98.9%, based on the one batch analysis. The two impurities are listed on the CSF because they are 

impurities of tox concern in addition to one other impurity present at the concentration of> 0.1 %, all other 

impurities if present are listed as other impurities'each < 0.1 %. The product chemistry data submitted 

corresponding to guideline 830.1550 (product identity & composition) satisfy the requirements of 

40CFR§158.155 [MRID No. 485015-01[. 

2. Certified limits were provided for the active ingredient and are based on certified limits proposed in 

guideline reference 830.1750. Upper certified limits were proposed for the impurities based on the batch 

analysis. The product chemistry data submitted corresponding to guideline 830.1750 satisfy the data 

requirements of 40CFR§ 158.175 [MRID 485015-01, CSF]. 

1 
9

) 

BARCODE: 0390006; Reg. No./FILr:: SYMBOL No.: 87829-R; PRODUCT: Willowood Propanil Technical 

3. The one batch analysis was performed at AgriFor Scientific pty Ltd., Unit 1,22-30 Delhi Road, North 

Ryde, 2113, Australia in compliance with 40 CFR§160 on Good Laboratory Practice. Analytical results 

were provided for one batch of the product. 

. The data submitted corresponding to the guideline reference 830.1700 (preliminary 

analysis, one batch only) satisfy the data requirements of 40CFR§158.170 [MRID No. 485015-01]. 

CONCLUSIONS: 

The TRB has reviewed the one batch analysis report submitted to support the revised basic CSF (dated 

05-19-11) and has concluded that 

1. The revised proposed CSF for the basic formulation (dated 05-19-11) is acceptable and is supported 

by one batch analysis. . 

2. The product chemistry data submitted correspon~iing to guideline 830.1700 (one batch analysis) is 

acceptable and supports the proposed basic CSF (dated 05-19-11). It is advised that the registrant must 

submit the full five batch analysis on the purified product when the batches are available. 

3. The results of analysis show that the two impurities of tox concern are below the EPA maximum 

permissible limits. 

2 

*Manufacturing process information may be entitled to confidential treatment*
10

) 

BARCODE: D390006; Reg. No. IFILl::: SYMBOL No.: 87829-R; PRODUCT: Willowood Propanil Technical 

830.1550: Product identity: (MRID No. 485015~01) 

Active ingredient 

Common nam~: 

IUPACname: 

, CAS name: 

Proponil 

i 3',4'·dichloropropiononilide 

: N·!3,4-dlchlorophenyljpropanomide' 

. CAS No. i 70~-9&s - -- ---.~~~ .. -------.... -.. - ... -.---------~-. . Fonnulcr. , 

----

'MolecUlorwelghf; : 218.1 

----_ ..... _-, 

r-----.,-.. -----j---. 

! Activity: ! Herbicide '- .. ________ ._L . __ _ 

Structure: 

CIX)NH~ I II CH, 

.& 0 

CI 

3 
Pages 11-20-*Manufacturing process information may be entitled to confidential treatment*
21

') 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

June 8, 2011 

CATHERINE M. BYRD 

WAGNER REGULATORY ASSOCIATES, INC 

WILLOWOOD PROPANIL, LLC 

PO Box 640 

HOCKESSIN, DE 19707-0640 

Report of Analysis for Compliance with PR Notice 86-5 

OFFlCEOF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Thank you for your submittal of 07-JUN-l1. 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 submittecl. 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. 
22

May 19, 2011 

Document Processing Desk 

ATTN: Kable Bo Davis, PM Team 25 

Registration Division 

U.s. Environmental Protection Agency 

Office of Pesticide Programs (7504P) 

Room 5-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, Virginia 22202-4501 

Dear Mr. Davis, 

Subject: WilJowood Propanil Technical - EPA Reg. No .. 87829-R 

Submission of Additional Product Chemistry Data 

Wagner Regulatory Associates, Inc 

P,O. Box 540 

7217 Lancaster Pike, Suite A 

Hockessin, Delaware 19707 

" c, c 

Wagner Regulatory Associates, Inc., as agent for WiJlowood PropaniJ, LLC is submitting the folJovving 

additional information and data in support of this pending registration. 

• Letter from WiJlowood propaniJ, LLC apPointing Wagner Regulatory Associates, Inc. as its agent 

• Confidential Statement of Formula, revised (8570-4), 2 copies 

• Data Transmittal Document 

• Preliminary Analysis data (3 copies) as outlined in the transmittal document. 

485015·00 

This submission follows up on the meeting of May 3rd between Lois Rossi, Jeff Herndon, Dan Kenny, Brian 

Heinze and myself where Willowood agreed to submit a new single production batch analysis for technical 

propanil and its impurities to support the pending registration. The lab has completed the analysis and issued 

the enclosed report. The results show that the impurities of concern are below the EPA maximum permissible 

limits. I have also enclosed a revised (SF to reflect these results and to show the upper certified limits to be 

equal to the EPA maximum permissible limits. Also, as agreed at the May 3rd meeting, Willowood agrees to 

conduct and submit, within 90 days of issuance of a con~itional registration, a report for preliminary analysis 

of 5 new production batches of Willowood's propanil technical product. That report will include the results of 

the current submission plus 4 additional production batches. 

Since this new information is in line with the agreements reached at the May 3 meeting I trust that after you 

review this new information you will be able to move aiiead with-the WilJowood registration. TilT!.itlB,as you 

know is very critical for Willowood. Any consideration you can provide on this will be greatly appr;s(hfed. 

If you have any questions about this submission please c.ontact me. 

Respectfully submitted, 

9r.ff:l!~ AgentforWiJlowood Propanil, LLC 

Tel: 302-635-7290 

email: lames@wagnerreg.com 

Enclosures 
23

1. 

DATA TRANSMITTAL DOCUMENT 

Name and Address of Submitter 

WiUowood Propanil, LLC 

clo Wagner Regulatory Associates 

PO Box 640 

Hockessin, DE 19707 

2. Regulatory Action In Support Of Wh'ich This Package Is Submitted 

Application for Registration 

Wiflowood Propanil Technical 

3. Transmittal Date 

May 19. 2011 

4. List of Submitted Studies 

'4850-1601 ,._-- vol:-T:-··S-kOpec, -:Jana(20 11) P;elimiJ;ariAnafy'ses of'O"TIe~P~-od'i:ictlon"Batch"of--""'-----" 

Propanil Technical Grade Active Ingredient (TGAI) To Determine Percent Propanil 

and to QuantifY Its Associated Impurities, AgriFor Scientific Pty Ltd., North Ryde, 

Australia. Report Number WW-034~ lB. Non-confidential portion 4 pages, 

Confidential portion 96 pages. 

Company Official: 

Company Name: 

Company Contact: 

Catherine M. Byrd 

Name 

Wagner Regulatory Associates, Inc. 

Agent for Willowood Propanil, LLC 

Catherine M. Byrd 

Name 

Signature 

302-635-7283 

Phone 
24

Propanil Technical5-Batch Replacement Pages 

Cheryl Wagner 

to; 

Kable Davis 

06/07/2011 12:31 PM 

Cc: 

"'James@wagnerreg. com''', catherine 

Show Details 

Hello Bo, 

Page 1 of I 

Jim Wagner asked me to send these replacement pages to you-unfortunately, these are the best copy 

available. The first page is just a copy of the title pag~ of the study for your reference. The replacement pages 

are pages 94, 95, and 96 of the report. 

Regards, 

Cfiery [1V agner 

Wagner Regulatorv Associates, Inc. 

Telephone: (302) 635-7289 

Fax: (302) 635-7295 

PLEASE NOTE NEW TELEPHONE AND FAX NUMBER!! 

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25

-OJ 

UNITEL ... TATES ENVIRONMENTAL PROTECT lOr-.. r'l.GENCY 

WASHINGTON, D.C. 20460 

May 27,2011 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

CA TIIERlNE M. BYRD 

WAGNER REGULATORY ASSOCIATES,INC 

WlLLOWOOD PROPANIL, LLC 

PO Box 640 

HOCKESSIN, DE 19707-0640 

Report of Analysis for Compliance with PR Notice 86-5 

, 

Thank you for your submittal of20-MAY-ll. Our staff has completed a preliminary 

analysis of the material. The results are provided as follows: 

We are unable to accept your data submittal for further processing and review, because of 

the significant deficiencies noted below. It is being returned to you for correction. If deficiencies 

were found which apply to your overall submission, they are described inunediately following 

this paragraph. Ifproblems are found with individual studes, they are described below linked to 

the study identifier found on the enclosed copy-of your bibliography. 

Rejected Study [0 I J: 

* The following pages in this study is/are illegibledue to the poor quality of the 

photocopying: Confidential Attachment 94~96. 

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26

May 19, 2.011 

Document Processing Desk 

AnN: Kable Bo Davis, PM Team 2.5 

Registration Division 

U.S. Environmental Protection Agency 

Office of Pesticide Programs (7504P) 

Room 5-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, Virginia 2.2.202-4501 

Dear Mr. Davis, 

Subject: Willowood Propanil Technical- EPA Reg. No. 87829-R 

Submission of Additional Product Chemistry Data 

'VI~A Wagner Regulatory Associates, Inc. 

P.O. Box 640 

7217 Lancaster Pike, SUite A 

Hockessin, Delaware 19707 

''>'''' .) , " , 

" 

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, 

, , 

wagner Regulatory Associates, Inc., as agent for Willowood Propanil, LLC is submitting the follol;~r~g " 

additional information and data in support of this pending registration. ~ >" ; > , 

• Letter from Willowood Propanil, LLC appointing Wagner Regulatory Associates, Inc. as its agent 

• Confidential Statement of Formula, revised (8570-4), 2 copies 

• Data Transmittal Document 

• Preliminary Analysis data (3 copies) as outlined in the transmittal document. 

This submission follows up on the meeting of May 3~~ between Lois Rossi, Jeff Herndon, Dan Kenny, Brian 

Heinze and myself where Willowood agreed to submit a new single production batch analysis for technical 

propanil and its impurities to support the pending registration. The lab has completed the analysis and issued 

the enclosed report. The results show that the impurities of concern are below the EPA maximum permissible 

limits. I have also enclosed a revised CSF to reflect these results and to show the upper certified limits to be 

equal to the EPA maximum permissible limits. Also, as agreed at the May 3rd meeting, WilJowood agrees to 

conduct and submit, within 90 days of issuance of a~sonditional registration, a report for preliminary analysis 

of 5 new production batches of Willowood's propariil,technical product. That report will include the results of 

the current submission plus 4 additional production batches. 

Since this new information is in line with the agreements reached at the May 3 meeting I trust that after you 

review this new information you will be able to move··ahead with the Willowood registration. TimjlJgps you 

know is very critical for Willowood. Any consideration you can provide on this will be greatly appre.duted. 

If you have any questions about this submission please contact me. 

Respectfully submitted, 

~~~r- Agent forWillowood Propanil, LLC 

Tel: 302-635-7290 

email: james@wagnerreg.com 

Enclosures 

, , , , " , , 

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, , " , 

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" 
27

DATA TRANSMITTAL DOCUMENT 

1. Name and Address of Submitter 

WilJowood Propanil, LLC 

clo Wagner Regulatory Associates 

PO Box 640 

Hockessin, DE 19707 

" , i 

2. Regulatory Action In Support Of Which This Package Is Submitted 

Application for Registration 

WiJlowood Propanil Technical 

3, Transmittal Date 

May 19, 2011 

4. List of Submitted Studies 

Reje'c£i01 j ----------'VOi~-'i:--Skopec-: J a"na(2'o T15P-reli~-inary 'A-naIYses-oTOnep;'-ocluction Batch -of" 

Propanil Technical Grade Active Ingredient (TGAI) To Detennine Percent Propanil 

and to QuantifY Its Associated Impurities. AgriFor Scientific Pty Ltd., North Ryde, 

Australia. Report Number WW-034-J R Non-confidential portion 4 pages, 

Confidential portion 96 pages. 

Company Official: 

Company Name: 

Company Contact: 

Catherine M. Byrd 

Name 

Wagner Regulatory Associates, Inc. 

Agent for Willowood Propanil. LLC 

Catherine M. Byrd 

Name 

Signature 

302-635-7283 

Phone 

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28

/':,--' 

~:::?~~ Re: WilJowood Propanil Technical impurities G:l 

'{f.::.:. 1//"'--' Dan Kenny to: James Wagner 

..:...J / Cc: "'Brian Heinze"', Shyam Mathur 

James Wagner wmowood Propanil Technicallmpurities 

06/08/201101:21 PM 

Dan Kenny Great! Thanks Jim! This helps quite a bit. Daniel Kenny Acting Chief, 

Great! Thanks Jim! This helps quite a bit. 

Daniel Kenny 

Acting Chief, Technical Review Branch 

Registration Division (7505P) 

Office of Pesticide Programs 

U.S. Environmental Protection Agency 

"James Wagner" HrOan, "' 

From: 

To: 

"James Wagner" <james@wagnerreg.com> 

Dan KennyIDC/USEPAlUS@EPA 

06/08/2011 12: 19:44 PM 

Cc: 

Date: 

Shyam Malhur/DC/USEPAfUS@EPA, "'Brian Heinze'" <brianh@willowoodusa.com> 

06/08/201112:19PM 

Subject: Willowood Propanil Technical impurities 

Hi Dan, 

Thanks again for getting back to me this morning. In response to Shyam's question on the impurities in 

the original eSF compared to the revised eSF, 1 can clarify the situation as follows: 

In the original eSF submitted with the application, the

HED viewed these impurities as 'not of 

tox significance'. 

In the new single batch analysis under review: 

The new report discusses the analysis of impurities <0.1% in Section 5.3, 1" paragraph. 

*Manufacturing process information may be entitled to confidential treatment*
29

I think this should resolve this matter, as all impurities noted in the original batch analysis and CSF have 

been accounted for in the new batch analysis and revised CSF. 

If there are any further questions please call me. Thanks again. 

Best regards, 

Jim Wagner 

Regulatory Consultant 

Tel: 302~635-7290 

Mobile: 302-530-5745 

" 

, 

, 

, 

, ; 
30

Fw: Willowood propanil technical - Reg No 87829-R 

Kable Davis to: Mindy Ondish 

""-- Forwarded by Kable Davis/DC/USEPAIUS on 05f20!2011 03:48 PM .--

From: 

To: 

Cc: 

Date: 

Subject: 

HiBo, 

"James Wagner" <james@wagnerreg.com> 

Kable Davis/DC/USEPAlUS@EPA 

"'Brian Heinze'" <brianh@willowoodusa.com> 

05/19/20t1 03:50 PM 

FW: Willowood propanil technical - Reg No 87829-R 

05/20/20t1 03:48 PM 

I am following up on the May 3 meeting where Willowood agreed to submit a new production batch 

analysis for propanil and its impurities to support the pending technical registration. 

The lab has completed the analysis and issued the enclosed report. The results show that the impurities 

of concern are below the EPA maximum pennissible limits. I have also enclosed 

a revised CSF to reflect these results and to show the upper certified limits to be equal to the EPA 

maximum pennissible limits. Since this new information is in line with the agreements reached 

at the May 3 meeting I trust that after you review this new .information you will be able to move ahead 

with the Willowood registration. Timing as you know is very critical for Willowood. 

Do you think the review of this infonnation could be completed within a week or so? I know that's very 

tight. Any consideration you can provide on this will be greatly appreciated. 

I am also submitting paper copies ofthe-CSF and the report by Federal Express for overnight delivery to 

the Agency. Please contact me if you have any questions or concerns about this submission. 

Best regards, 

Jim Wagner 

Regulatory Consultant 

Tel: 302-635-7290 

Mobile: 302-530-5745 

Wi'lgner Regulatory Ass<Jdates, Inc. 

From: James Wagner [mailto:james@wagnerreg,com) 

Sent: Monday, May 09, 2011 7:40 PM 

To: 'Davls,Kable@epamail.epa.gov' 

Cc: 'Catherine Byrd' 

Subject: Willowood propanil technical 

HiBo, 
31

I hope you are doing well. Dan Kenny may haVe told you about the meeting that Brian Heinze and I had 

with Lois Rossi, Jeff Hemdon and Dan on May 3. Regarding that meeting I wanted you to have a copy 

of my summary of the meeting - copy enclosed. If there are any outstanding issues that we did not 

address in the meeting with Lois, for example, labeling revisions, I would be grateful if you could alert 

me about those as soon as you are able. I am not aware of any but just wanted to be sure. 

Thanks for any help you can provide. 

Best regards, 

Jim Wagner 

Regulatory Consultant 

Tel: 302~635-7290 

Mobile: 302-530-5745 

Wagner Regulatory A%odate~, 11K 

"';t 

Final AFS Propanill balch Report \IIW·034·1 B.pdf 

,.' ,: 

.~ 

. . '_. CSF WillowDod Propanil Tech 19MAY11.pdf 

.. ' 
32

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

Wastiington, D.C. 20460 

James M. Wagner, Agent 

Wagner Regulatory Associates, Inc. 

clo Willowood Propanil, LLC 

P.O. Box 640 

Hockessin, DE 19707-0640 

Subject: Propanillmpurities Review 

Willowood Propanil Technical. 

EPA Reg. No. 87829-R 

Application Dated August 13;2010 

Dear Me. Wagner: 

MAR 29 2011 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

The Agency has conducted its imp.urities review for the subject proposed 

propanil technical product, and has concluded that the subject product is not 

substantially similar to the cited product based on the impurity profile. Specifically, the 

Agency has concerns about impurity #2 due to tts elevated level. The Agency believes 

that the presence of impurity #2, in the abs.ence of toxicity data, poses additional toxicity 

of unknown levels. Therefore, etther an eXtensive toxicity testing for impurity #2 must 

be conducted, or the manufacturing proce~s must be modified to ensure that the levels 

of impurity #2 and other related structures (including impurity #3) are within acceptable 

levels. 

Please refer to the enclosed copy of the impurities review (DP387281) dated 

March 24, 2011 for further details.' ;. 

If you have any questions, please contact Mindy Ondish at (703)605-0723 or at 

ondish.mindy@epa.gov. 

Sincerely, 

Kable Bo Davis 

Product Manager 25 

Herbicide Branch 

Registration Division (7505P) 
33

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

Washington, D.C. 20460 

James M. Wagner 

Wagner Regulatory Associates, Inc. 

P.O. Box 640 

7460 Lancaster Pike, Suite 9 

Hockessin, Delaware 19707 

MAR i 9 2011 

Re: Willowood Propanil, LLC 

Willowood Propanil Technical 

EPA File Symbol 87829-R . 

Application for Registration Received August 16,2010 

Dear Mr. Wagner: 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

This is in regard to an application for p.~sticide registration submitted by Willowood 

Propanil, LLC (Willowood) for a teclmical prdduct containing propanil as an active ingredient, 

EPA File Symbol 87829-R. As you are presumably aware, the Propanil Task Force submitted to 

the Agency on January 25, 2011 a petition to qerry your application because of (unidentified) 

flaws in the Offer to Pay data compensation you submitted on Willowood's behalf to the Task 

Force. In our review of your Offer to Pay (attached by the Task Force to its petition), we have 

identified a potentially significant issue in that,Offer that must be clarified or corrected before 

the Agency can act on your application. Spec{fically, in the last paragraph of the Offer, you ask 

each data submitter to identify to you the data-for which they intend to seek compensation and 

the amount of compensation they propose. Y o.ur Offer then goes on to add: "If we do not receive 

your response within 90 days, we will presume that your company seeks no compensation." 

Vlhile it is not clear what you mean by;~the "presumption" that a data submitter seeks no 

compensation, EPA believes that neither FIFRA nor the Agency's implementing regulations 

authorize an applicant seeking to rely on compensable data submitted by another person to 

condition an offer to pay on the timing of a request for compensation. Given that your 

application is contingent upon the Agency's consideration of data submitted by other persons, 

this issue needs to be satisfactorily resolved before EPA can complete action on your application. 

You can resolve this issue either by 1) sending a letter to each company on the data submitter's 

list for propanil clarifying that you did not intend the sentence quoted above to limit a data 

submitter's right to seek compensation after 90 days; or 2) sending a new offer to pay to each 

company on the data submitter's list for propanil that does not include any language purporting 

to limit a data submitter's right to seek compensation if a request is not made within any 
34

particular time frame, Please notify me when you have corrected this situation by sending 

corrected material to the data submitters and provide me a copy of whatever you provided to the 

data submitters. As noted above, EPA will not be able to complete action on your application 

until this matter is corrected, 

If you have any questions on this matter, please feel free to contact me at (703) 308-7038. 

cc: Christopher Lahiff, Esq. 

Sincerely, 

Meredith F. Laws 

Acting Chief 

Herbicide Branch 
35

Fw: Petition to Deny Application for Registration of Willowood Propanil LLC 

(25 January 2011) 

Kathryn Montague to: Meredith Laws, Kable Davis, Mindy Ondish 01/31/201108:36 AM 

FYI. ... 

Kathryn V. Montague 

Product Manager 23 

OPPTS/OPP/RD/HB 

t200 Pennsylvania Ave., NW 

Mailcode 7505P 

Washington, DC 20460 

Phone: (703)305-1243 • 

o-I'{eo- --\> P"1 is.=-c cle ccred bj 

o ex G .pc',0{'- --ro ~--t-r<X---t cO<) . 

&/15/ 1 r ""0 

~."~ Forwarded by Kathryn Montague/DC/USEPAJUS on 01l31/20t1 08:37 AM--

From: MicheJe Knorr/DC/USEPA/US . 

To: "Lahiff, Christopher" <clahiff@mwe.co'rn> 

Cc: "Ruckert, Edward" <eruckert@mwe.com>, "james@wagnerreg.com"<james@wagnerreg.corn>, 

Kathryn Montague/DC/USEPAlUS@'E;PA 

Date: 01/25/201110:25AM 

Subject: Re: Petition to Deny Application for Registration of Willowood Propanil LLC (25 January 2011) 

The petition has been forwarded to Robert Perlis. Thanks 

Michele Knorr 

U.S. EPA 

Office of General Counsel 

Pesticides and Toxic Substances Law Office 

202-564-5631 

"Lahiff, Christopher" Dear Ms. Knorr and Ms. Montague: On behalf... 

From: "Lahiff, Christopher" <clahiff@mwe.com> 

01/25/201 t 10:23:34 AM 

To: 

Cc: 

Date: 

Michele Knorr/DC/USEPAlUS@EPA, Kathryn Montague/DC/USEPAlUS@EPA 

"james@wagnerreg.com"<james@wagnerreg.com>, "Ruckert, Edward" <eruckert@mwe.com> 

01/25/2011 10:23 AM 

Subject: Petition to Deny Application for RegTSitration of Willowood Propanil LLC (25 January 2011) 

Dear Ms. Knorr and Ms. Montague: 

On behalf of the propanil Task Force,. we hereby file the attached Petition to 

Deny the Application for Registration ,submitted by Willowood Propanil LLC. By 

this email a copy of the Petition is also being served concurrently on James 

Wagner, agent for Willowood Propanil: please contact me if you have any 

questions or need additional information. Thank you. 

Christopher M. Lahiff, Esquire 

McDermott will & Emery LLP 

600 13th Street, N.W. 

Washington, D.C. 20005 

phone: 202.756.8219 

fax: 202.756.8087 

email: clahiff@mwe.com 
36

****************************************************************************** 

************************************* 

IRS Circular 230 Disclosure: To comply with requirements imposed by the IRS, 

we inform you that any u.S. federal tax advice contained herein (including any 

attachments), unless specifically stated otherwise, is not intended or written 

to be used, and cannot be used, for the purposes of (i) avoiding penalties 

under the Internal Revenue Code or (ii) promoting, ,marketing or recommending 

to another party any transaction or matter herein. 

This message is a PRIVILEGED AND CONFIDENTIAL communication. This message and 

all attachments are a private commu~ication sent by a law firm and may be 

confidential or protected by privilege. If you are not the intended recipient, 

you are hereby notified that any disclosure, copying, distribution or use of 

the information contained in or attached to this message is strictly 

prohibited. please notify the sende;, of the delivery error by replying to 

this message, and then delete it from·your system. Thank you. 

***** *** ** *** * * * ** ** * * * ** *** *** * * ** **;j< ** * * * * * * ** ** ** * * * **** ** * ** ** * * * * * *** * * ** 

************************************~ 

please visit http://www.mwe.com/ for~_more information about our Firm. 

[attachment "petition to Deny Willowood.PDF" deleted by Michele 

Knorr/DC/USEPA/USl ~ ~ ~ 

./ 
37

RE: 87829-R label comments 

Catherine Byrd to: Mindy Ondish 03/03/20 t1 11:56 AM 

--;-~ Cc: ______ "James M. Wagner" ~ __ ~~_« __ <_~ ____ oo_<_«~ ___ o< __ 0 ______ 0 ___ < ____________ < 

1 attachment 

~1 ~ 

87829~ 1.201 to303.v1.pdf 

Goad afternoon, 

I have attached a copy of the revised label. Please let me know if you need 

anything else. 

Thank you, 

Catherine M. Byrd 

Regulatory Associate 

P.O. Box 640 

7460 Lancaster Pike, Suite 9 

Hockessin, Delaware 19707 

P; 302.234.2780 

F: 302.234.7570 

www.wagnerreg.com 

---~-original Message----- < 

From: James Wagner [mailto:james@wagnerreg.com) 

Sent: Thursday, March 03, 2011 10:50 AM 

To; 'Ondish.Mindy@epamail.epa.gov' 

Subject: RE: 87829-R label comments 

Hi Mindy, 

We will update the label and get it b,ack to you in next couple days. 

Best regards, 

Jim Wagner 

Regulatory Consultant 

Tel: 302-234-8550 

-----Original Message-----

From: Ondish.Mindy@epamail.epa.gov [mailto:Ondish.Mindy@epamail.epa.gov] 

Sent: Wednesday, March 02, 2011 5:14 PM 

To: james@wagnerreg.com 

Subject: 87829-R label comments 

Jim, 

Please make the following changes to the proposed label for 87829-R and 

resubmit for review. 
38

1 

1. Change "Inert Ingredients" to "Other Ingredients". 

2. Add the EPA Reg. No. "87829-1". 

3. In the last paragraph on page 2, change "December 1, 2007" to 

"December 1, 2011", and correct the typo from "mitigatigation" to 

"mitigation". ' 

4. Move the statement "Do not contaminate water, food, or feed by 

storage or disposal." from the Pesticide Storage section to directly 

below the Storage and Disposal heading. 

Thanks, 

Mindy Ondish 

Biologist / Risk Manager 

Herbicide Branch (PM Team 25) 

Registration Division (750SP) 

Office of Pesticide Programs 

U.S. Environmental Protection Agency 

phone: 703-605-0723 
39

Recommendation of Division Directors 

Negotiated Due Dates 

Decision #: 438732 ! Registration #: 87829-R Petition #: N/A 

Fee Category: R310 < PRIA Decision Time Frame: 6-months 

Submitted by: Mindy Ondish Branch: HB I Date: 3/3111 

Company: Willowood Propanil, LLC c/o Wagner Regulatory Associates, Inc. 

Original Due Date: March 6, 2011 I Proposed New Due Date: Aprill, 2011 

Previous Nel!otiated Due Dates: N/A < 

Is the "Fix" in-house? Yes I If not, date "Fix" expected: 

Issue (describe in detail): < 

The proposed propanil technical fonnulation contai~s impurities that are absent in the cited technical 

product's fonnulation. RD/TRB's product chemisiry review could not detennine substantial similarity and 

has recommended that RED conduct an impurities-review. 

Summary of Deficiency Type(s): Not Submitted (N) or Deficiencies (D) 

Product Chemistry: _(D)_ Acute Tox: _ Efficacy: _ Labeling: _ Other (describe):_ 

Describe Interactions with Company (describe when contacted and company's response including 

response to previous negotiated due dates): 

< 

Emailed agent on 2/17111 notifying them of the deficiency and requested to renegotiate the due date for an 

additional 90-days to allow for RED impurities review. Agent submitted fonnal toxicology rebuttal which 

was reviewed by TRB on 3/1/11 and detennined it still required RED review. Agent refused to renegotiate 

for 90-days stating it would jeopardize this year's use season, but was willing to extend for 30-days. RD 

has agreed to accept the agent's proposal for a 30-day extension. 

"7S-Day" Letter sent? Yes X N6 and reason for none? Contacted via email - - - ;.-. 

Rationale for Proposed Due Date: 

To allow time for RED to conduct an impurities review. 

Registrant notified that this is the last negotiation? _Yes _X_ Not Applicable 

Approve: V I Disapprove: 

If disapproved, action to be taken: 

OD or DOD Signature: Date: 

LJJ\ C ') 

, 3·1j.!1 
40

Fw: Re: 87829-R Impurities review and due date negotiation 

Kable Davis 

to: 

Mindy Ondish 

03/02/201104:53 PM 

Show Details 

FYI 

) 

-----Forwarded by Kable Davis/DCjUSEPAjUS on 03/02/2011 04:53PM -----

To: Kable Davis/DC/USEPA/US@EPA 

From: Jim2 <james@wagnerreg.com> 

Date: 03/02/2011 04:50PM 

Subject: Re: 87829-R Impurities review and due date negotiation 

Dear Bo 

Page 1 of3 

On behalf of Willowood I agree to extend the pria date by 30 days. 

Thanks for your help on this. 

Jim Wagner 

(from mobile phone) 

On Mar 2, 2011, at 3:58 PM, Davis.Kable@epamail.epa.gov wrote: 

> Jim-

> 

> Please give me a call to discuss. 

> 

> Thanks-

> Bo 

> 

> Kable Bo Davis 

> Product Manager 25 

> U.S. Environmental Protection Agency 

> Herbicide Branch 

> Registration Division (750SP) 

> 1200 Pennsylvania Ave. NW 

> washington, DC 20460 

> 

> Tel: 703 306-0415 

> Email: davis.kable@epa.gov 

> 

> 

> 

> From: 

> To: 

,.., ",." ...... 

IIJames Wagner II <james@wagnerreg.com> 

Kable Davis/DC/USEPA/US@EPA 
41

From: 

To: 

Cc: 

Date: 

Subject: 

Dear Bo, 

"James Wagner" <:james@wagnerreg.com> 

Kable Davis/DC/USEPAlUS@EPA. 

"'Brian Heinze'" <:brianh@wiliowoodusa.com>,Mindy Ondish/DC/USEPAlUS@EPA, Meredith 

LawslDC/USEPAlUS@EPA, "'Elliot.Gordon'" <:ebgfox@comcast.net> 

03/0212011 10:24 AM 

RE: FW: 87829-R Impurities review and due date negotiation 

We have reviewed the TRB memo from yesterday referring the matter to HED. We disagree with this 

decision and I have outlined below our position ori'this. But first I want to describe the commercial 

problem that this decision creates for Willowood. 0 Propanil use in rice production occurs primarily in 

April thru May. An additional 90 days extension will mean that Willowood completely looses all sales 

for propanil this year. Because of the severe commercial impact from a 90 day extension, the head of 

Willowood, Brian Heinze, may request to meet with Meredith Laws or Lois Rossi for this week. 

However, I am thinking that maybe there is still a chance to resolve this without a meeting. If so, I would 

very much like to try. 

2. The TRB memo from yesterday states that TRB can only make decisions on impurities where it 

involves acute toxicity concerns. However, I have personally registered the technical products 

*Manufacturing process information may be entitled to confidential treatment*
42

The concentration levels were below the Agency's 

level of concern and the products registrations were approved without extending the PRIA dates. The 

TRB position on propanil appears to be inconsistent with previous decisions for other compounds. 

3. Mindy's email indicates that the Agency would require a 90-day PRIA extension for HED evaluation. 

As I indicated above 90 days is not acceptable from Willowood's business point of view. However, a 

30-day extension justrnight be acceptable. I wo:uld like to discuss this possibility. I would also like to 

discuss possibility of conditional registration. 

I will call you this morning to discuss. Thanks f(jr your consideration in this matter. 

Best regards, 

Jim Wagner 

Regulatory Consultant 

Tel: 302·234.8550 

-----Original Message-----

From: Ondish.Mindy@epamail.epa.gov [mailto:Ondish.Mindy@epamail.epa.gov] 

Sent: Tuesday, March 01, 20114:13 PM 

To: James Wagner 

Cc: 'Brian Heinze'; Davis.Kable@epamail.epa.gov 

Subject: Re: FW: 87829-R Impurities review and due date negotiation 

Jim, 

TRB reviewed your rebuttal and has determined that it still needs to be sent to HED for review. Please 

see attached memo. If you wish to continue with this registration application the PRIA due date must be 

renegotiated with you for an additional 90 days. Please response with your intent by COB tomorrow. 

Sincerely, 

Mindy Ondish 

(See attached file: 87829-R Impurities rebuttal revJew.pdf) 

From: 

To: 

Cc: 

Date: 

"James Wagner" <james@wagnerreg.com:? 

Kable DavisIDCIUSEPAlUS@EPA 

Mindy Ondish/DC/USEP AlUS@EPA, "'Brian Heinze'" 

<brianh@Willowoodusa.com> 

02/221201 I 04:58 PM 

Subject FW: 87829-R Impurities review and due date negotiation 

Dear Bo, 

*Manufacturing process information may be entitled to confidential treatment*
43

! 

Thanks again for providing me a copy of the chemistry review comments last Friday. My toxicologist and 

I have discussed the chemistry review and then he prepared the attached document which fully addresses 

the issue on impurities of concern. I have previoll,sly been able to provide similar to RD for other 

compounds and avoided the need for HED review. If Shyam Mathur could spare some time to consider 

the attached I think he might agree on the conclusions. Timing on this registration is so critical to 

Wlliowood as the rice season for propanil is an early one and a 90-day PRIA extension would mean 

missing the current use season completely. 

We would greatly appreciate any help you can provide to facilitate resolution of this matter. I will call 

you on Wednesday to discuss. 

Thanks for your consideration. 

Best regards, 

Jim Wagner 

Regulatory Consultant 

Tel: 302-234-8550 

~~~~~Original Message~~~~~ 

From: Davis.Kable@epamail.epa.gov [mailto:Davis.Kable@epamail.epa.gov] 

Sent: Friday, February 18,201110:59 AM 

To: james@wagnerreg.com 

Cc: Ondish.Mindy@epamail.epa.gov; Catherine Byrd 

Subject: Fw: 87829~R Impurities review and due date negotiation 

Jim~ 

Thanks for the phone call earlier. As I stated on the phone, we normally do not send CBl documents via 

email (which is why Mindy didn't send it in her or:iginal email). However, since you said it would be 

acceptable to do so, I have attached the completed product chemistry review for EPA File Symbol 

87829~R. Let me or Mindy know if you have any.questions. 

Have a nice weekend. 

Sincerely, 

Bo 

(See attached file: 87829~R (product chemistry review).pdf) _____________ _ 

Kable Bo Davis Product Manager 25 U.s. 

Environmental Protection Agency Herbicide Brancp- Registration Division 

(7505P) 1200 Pennsylvania Ave. NW Washington, DC 20460 

Tel: 703 306-0415 

Email: davis.kable@epa.gov 

---~- Fotwarded by Kable DavislDCIUSEPAIUS on 0211812011 10:52 AM ~-~--

From: Mindy Ondish/DC!USEPAIUS 

To: Catherine Byrd <Catherine@wagnerreg.com> 
44

Cc: 

Date: 

Kable DavisiDC/USEP AlUS@EPA 

02/17/2011 04:36 PM 

Subject: 87829-R Impurities review and due date negotiation 

Catherine, 

Your application for 87829-R (Willowood Propanll Technical) has a PRIA due date of 3/611 1. However, 

product chemistry review could not determine sObstantial similarity of the technical formulation and an 

impurities review will need to be conducted, which will require an additional 90 days. As a result, the 

PRIA due date will need to be negotiated with you if you wish to continue with this application. 

Please respond by COB Wednesday, February 23,2010 on how you wish to proceed with this 

application. 

Sincerely, 

Mindy Ondish 

Biologist 1 Risk Manager 

Herbicide Branch (PM Team 25) 

Registration Division (7505P) 

Office of Pesticide Programs 

U.S. Environmental Protection Agency 

Phone: 703-605-0723 

[attachment "Willowood Propanil- impurities oftqx concem.pdf' deleted by Mindy 

~ . 

OndishlDC/uSEPA/USJ 87829·R Impurities rebuttal review.pdf 
45

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

Date: 24-MAR-2011 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

Subject: Propanil: EPA Reg No. 87829-R. Discussion ofImpurities for New Formulation. 

PC Code: 028201 

Decision No.: 438732 

Petifion No.: NA 

DP Barcode: D387281 

Registration No.: 87829-R 

Regulatory Action: New Registration 

Risk Assessment Type: NA Case No.: NA 

TXRNo.: NA CAS No.: 709-98-8 

MRIDNo.: NA 40 CFR: 180.274 

From: 

Through: 

To: 

Mohsen Sahafeyan, Chemist 

Risk Assessment Branch 6/Health Effects Division 

Felecia Fort, Branch Chief . ,~ (} I 

RAB6/HED (7509P) ~,\lLU 6( 0, Jed. 

and . 

Christine Olinger, Senior Chemist /J/ I L/£ '-

RAB7/HED (7509P) V""" A,V" '--------

Mindy Dudish, Risk Manager Reviewer 

Herbicide Branch 

Registration Division (7505P) 

I. Action Requested 

Willowood Propanil, LLC has proposed registration of a new fonnulation for a technical grade 

active ingredient (TGAI) of propanil that has a different impurity profile from the currently 

registered TGAL The Registration Division (RD) has requested RED comment on four 

impurities and their potential effects on the toxicity of the TGAI. 

II. HED Conclusions 

Based on the similarity of the chemical structure ofthe impurities with other compounds of 

toxicological concern, the levels and nature of toxicity for the impurities are expected to be 

different than the parent. Specifically, BED has concerns about metabolite 2 due to its elevated 

Page I of2 
46

level in the proposed TGAI (> 1 ppm). HED believes that the presence of impurity 2, in the 

absence of toxicity data poses additional toxicity of unknown levels. Therefore, the registrant 

should conduct extensive toxicity testing for impurity 2. Alternatively, the registrant should 

modify the manufacturing process to ensure that the levels of impurity 2 and other related 

structures (including impurity 3) are below 1 'ppm. A detailed discussion of the toxicity and 

analysis may be found in the Confidential Appendix to this memorandum. 

Attachments: 

Confidential Appendix 

Page 2 of2 
47

1 

Confidential Appendix to D3 t) r281 

Impurity Description 

RD inquired about the impurities in the proposed confIdential statement of formula for EPA reg. 

no. 87829-R, which are listed in Table A-I. In addition to an expert review of the toxicity 

databases of similar chemicals, HED used a qualitative toxicity prediction tool, DEREK (Nexus 

v. 2.0), to conduct a qualitative structure-activity relationship analysis for the parent and 

metabolites. The DEREK reports are available upon request. 

4-

upper 

Propanil Hazard Characterization 

98.5 

LCL= 

Reference: Griffin, R., Human Health Risk Assessment); D281147, 2/28/2002. 

100 95.55 

The toxicological database for propanil is cori'~idered minimally adequate for hazard 

characterization. The studies submitted to support guideline requirements are supplemented by 

relevant open literature publications. --

In general, propanil has low acute toxicity (although primary eye irritation is observed in 

rabbits). The principal toxic effect of propanil is methemoglobinemia and hemolytic anemia, 

which is seen in different species, in studies of varying lengths of time. Methemoglobinemia 

results in the development of hemolytic anemia with decreases in hemoglobin, red blood cell 

(REe) count, and packed cell volume. Other than slightly decreased fetal body weights (with or 

Page 1 of2 

1 

Confidential Appendix to D3 t) r281 

Impurity Description 

RD inquired about the impurities in the proposed confIdential statement of formula for EPA reg. 

no. 87829-R, which are listed in Table A-I. In addition to an expert review of the toxicity 

databases of similar chemicals, HED used a qualitative toxicity prediction tool, DEREK (Nexus 

v. 2.0), to conduct a qualitative structure-activity relationship analysis for the parent and 

metabolites. The DEREK reports are available upon request. 

Propanil 

CAS name: N-(3, 4-

dichlorophenyl) propanamide 

CAS No. 709-9g...8 

98.5 

NC nominal concentration, VCL upper certified hmlt, LCL lower certified hm!t. 

Propanil Hazard Characterization 

Reference: Griffin, R., Human Health Risk Assessment); D281147, 2/28/2002. 

100 95.55 

The toxicological database for propanil is cori'~idered minimally adequate for hazard 

characterization. The studies submitted to support guideline requirements are supplemented by 

relevant open literature publications. --

In general, propanil has low acute toxicity (although primary eye irritation is observed in 

rabbits). The principal toxic effect of propanil is methemoglobinemia and hemolytic anemia, 

which is seen in different species, in studies of varying lengths oftime. Methemoglobinemia 

results in the development of hemolytic anemia with decreases in hemoglobin, red blood cell 

(REe) count, and packed cell volume. Other than slightly decreased fetal body weights (with or 

Page 1 of2 

*Manufacturing process information may be entitled to confidential treatment*
48

I 

Confidential Appendix k J387281 

without accompanying delays in skeletal ossification) there was no apparent adverse effect of in 

utero propanil exposure on the morphological development of the fetuses in the prenatal 

developmental toxicity studies in rats and rabbits. Effects observed in the two generation 

reproduction study in rats (delayed vaginal perforation, delayed balanopreputial separation, and 

decreased mean spenn count) are highly suggestive of neuroendocrine disruption. Also, there is 

evidence in the peer~reviewed literature that propanil has immunotoxic potential and therefore 

propanil is classified into the category of "Suggestive evidence of carCinogenic potential by all 

routes of exposure, but not suffiCient to ass~ss human carcinogenic potential. " 

HED Conclusions 

After review of the toxicity for the impurities'identified, a qualitative toxicity prediction tool 

(DEREK) was used to screen for potential hazards not included in the parent compound. As a 

positive control, the DEREK model was run (<;Ir the parent propanil. As it is seen in Table A-I, 

compounds, all of which are of high toxicity~" -Some of the DEREK alerts for impurities 2 and 3 

that are also observed for the parent are ofmu¢h higher concern than the parent as they relate to 

Specifically, RED has concerns 

about metabolite 2 due to its elevated level (>] ppm). RED believes that the presence of 

impurity 2, in absence of toxicity data poses additional toxicity of unknown levels. Therefore, 

the registrant should conduct extensive toxicity testing for impurity 2. Alternatively, the 

registrant should modify the manufacturing prpcess to ensure that the levels of impurity 2 and 

other related structures (including impurity 3)" are below I ppm. 

Page 2 of2 

*Manufacturing process information may be entitled to confidential treatment*
49

March 1,2011 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

MEMORANDUM 

Subject: 

From: 

To: 

Registrant: 

Name of Pesticide Product: 

EPA Reg. No. IFi1e Symbol: 

WILLOWOOD PROPANIL TECHNICAL 

87829-R 

DP Barcode: DP 382829 

Decision No.: 438732 

Action Code: R310 

PC Codes: 028201 (Propani1: 98.5%) 

Byron T. Backus, Ph, D., Toxicologist 

Technical Review Branch 

Registration Division (750SP) 

Shyarn Mathur 

Product Chemistry Team Leader 

Technical Review Branch 

Registration Division (750SP) 

WILLOWOOD PROPANIL, LLC 

(3~~_n~ 1 I.) 1..-e.\.' f'vL _.r....-~ 

Comments and Recommendations: 

The registrant has claimed similarity of their proposed product (87829-R, Willowood Propanil 

Technical) to the existing registered product 71085-28, However, 87829-R contains 3 impurities 

which are not present in 71085-28. 

The registrant states that: "Two of the three impurities are present at levels that are below those 

The third impurity is not expected 

to return "Structural Alerts" from Quantitative Structure Activity Relationship (QSAR) analyses 

that differ from the parent compound." 

The Toxicology Team ofTRB normally makes recommendations based on acute (short term) 

toxicity considerations, but the concerns regarding these impurities involve potential chronic 

(long term) effects. 

Page 1 of2 

*Manufacturing process information may be entitled to confidential treatment*
50

! 

risk analyses by RED might result in lower values. TRB's conclusion is that BED should make 

the [mal decisions and recommendations regarding these impurities. 

Page 2 of2 
51

Willowood USA's Propanil Technical 

The Basis for Substantial Similarity to Registered Product 71085-28 

Prepared for: 

James M. Wagner 

Wagner Regulatory Associates, Inc. 

PO Box 648, 7460 Lancaster Pike, Suite 9 

Hockessin, DE 19707 

Prepared by: 

Elliot Gordon, PhD, DABT 

Elliot Gordon consulting, LLC 

55 Lillie Street 

Princeton Junction, NJ 08550 

February 22, 2011 
Pages 52-62 - *Manufacturing process information may be entitled to confidential treatment*
63

) 

DATA EVALUATION RECORD 

PROPANIL 

(Willowood Propanil Technical) 

STUDY TYPES: Product Identity and Composition (OPPTS 830.1550) 

Primary Reviewer: 

Description of Materials Used to Produce the Product (OPPTS 830.1600) 

Description of Production Process (830.1620) 

Discussion of Formation of Impurities (OPPTS 830.1670) 

Preliminary Analysis (OPPTS 830.1700) 

Certified Limits (OPPTS 830.1750) 

Enforcement Analytical Method (OPPTS 830.1800) 

Physical and Chemical Characteristics (OPPTS 830.6302-830.7950) > 

MRIDs 481976-01 through 481976-05 

Prepared for 

Registrat~on Division 

Office of Pesticide Programs 

U.s. Environmental Protection Agency 

One Potomac Yard 

2777 South Crystal Drive 

Ar1ingtori~ VA 22202 

Prepared by 

Toxicology and Hazard Assessment Group 

Environmental Sciences Division 

Oak Ridge Na.uonal Laboratory 

Oak Ridge, TN 37831 

Task Order No. 1-35 

Anthony O. Armstrong, M.S. Signature: 

Date: 

Secondary Reviewers: 

Sylvia Milanez. Ph.D .. D.A.B.T. Signature: 

Date: 

Robert H. Ross. M.S., Group Leader Signature: 

Date: 

Quality Assurance: 

Kimberly G. Slusher, M.S. Signature: 

Date: 

Disclaimer 

This review may have been altered subsequent to the contractor's signatures above. 

Oak Ridge National Laboratory managed and operated by UT.Battelle, LLC., for the U.S. Department of Energy 

under Contract No. DE-AC05-000R22725. 
64

BARCODE: D382829; Reg. No./F!LE SYMBOL No.: 87829-R; PRODUCT: Willowood Propanil Technical 

Date: 

SUBJECT: 

FROM: 

TO: 

February 1, 2011 

FEE. Product Chemistry Rev'lew ofWlllowood Propani! Techn'lcal TGA!/MUP 

Shyam Mathur 

Product Chemistry Team Leader 

Technical Review Branch/RD (7505P) 

Mindy Ondish / Kable Davis, RM-23 

Herbicide Branch / RD (7505P) 

DP BARCODE: 0382829 

DECISION No.: 438732 

Registration Number 1 File Symbol No.: 87829-R 

PRODUCT NAME: Willowood Propani! Technica! 

PCC: 028201 

REG!STRANT: Willowood Propanil, LLC 

USE: Herbicide 

FOOD USE: Yes [XJ No [ J 

MR!D Numbers: 481976-01 through 481976-05 

INTRODUCTION: 

Wagner Regulatory Associates, Inc., on behalf of Willowood Propanil, LLC Company, has submitted an 

application for the registration of the Willowood Propanil Technical 

The registrant has claimed that the proposed technical is 

substantially similar to the registered product with Reg. NO.71 085-28. The applicant has submitted group 

A & group B data with MRID Nos. 481976-01 through 481976-05, the basic CSF (dated 8-13-10) and the 

product !abel. The primary review was conducted by Oak Ridge National Laboratory. TRB has been 

asked to perform the secondary review of the data submitted. 

SUMMARY OF FINDINGS: 

1. The registrant has submitted a Confidential Statement of Formu!a for a basic formulation (dated 

8/13/2010) ofWiliowood Propanil Technical. The proposed nominal concentration of the active ingredient 

is 98.5%, based on the five-batch analysis. The two impurities are listed on the CSF because they are 

impurities of tox concern. The product chemistry dflta submitted corresponding to guideline 830.1550 

(product 'Identity & composition) sat'lsfy the requirements of 40CFR§158.155 [MRID No. 481976-01]. 

2. Certified limits were provided for the active ingredient and are based on certified limits proposed in 

gUideline reference 830.1750. Upper certified limits were proposed for the impurities based on the fivebatch analysis. The lower certified limits for all impurities should be removed from the CSF. The product 

chemistry data submitted corresponding to guideline 830.1750 satisfy the data requirements of 40CFR§ 

158.175 [MRID 481976-02, CSFJ. 

2 

*Product ingredient source information may be entitled to confidential treatment*
65

BARCODE: 0382829; Reg. No./FILE SYMBOL No.: 87829-R: PRODUCT: Willowood Propanil Technical 

3. MSDSs were submitted for all starting materials. The product chemistry data submitted corresponding 

to guideline reference 830.1600 (description of material used to produce the product) satisfy the data 

requirements of 40CFR§ 158.160 [MRID No. 481976-01]. 

4. The product is manufactured 

by using a batch process. Sufficient details of the process were provided. The product chemistry data 

submitted corresponding to guideline reference 830.1620 (description of production process) satisfy the 

data requirements for40CFR§158.162 [MRID Nci: 481976-01]. 

5. There are two impurities of toxicological signifiGance which are required to be analyzed for in the 

potential impurities in the product are identified, anQ their origin and mechanism of formation were 

provided. The product chemistry data submitted corresponding to guideline reference 830.1670 

(discussion on the formation of impurities) satisfyl~e data requirements for 40CFR§158.167 [MRID No. 

481976-02J. 

6. The preliminary analysis was performed at AgriFor Scientific Pty Ltd., Unit 1, 22-30 Delhi Road, North 

Ryde, 2113, Australia in compliance with 40 CFR§160 on Good Laboratory Practice. Analytical results 

were provided for five batches of the product. 

. The data submitted corresponding to the 

guideline reference 830.1700 (preliminary analysis) satisfy the data requirements of 40CFR§158.170 

[MRID No. 481976-02J. 

7. The enforcement analytical method to determine the content of active ingredient is HPLC-UV. The 

method was validated for linearity, accuracy, and "precision. The data submitted corresponding to the 

guideline reference 830.1800 (enforcement analytical method) satisfy the data requirements of 

40CFR§158.180 JMRID No. 481976-02 and 481976-03J. 

8. The data submitted corresponding to guidelines 830 Series Subgroup B (physical-chemical properties) 

satisfy the data requirements of 40CFR§158.190. Corrosion and stability studies will be submitted by the 

registrant as a condition of product registration [M~ID No. 481976-04 and 481976-05]. 

3 

*Product ingredient source information may be entitled to confidential treatment* *Manufacturing process information may be entitled to confidential treatment*
66

BARCODE: 0382829; Reg. No./F!LE SYMBOL No.: 87829-R; PRODUCT: Willowood Propanil Technical 

CONCLUSIONS: 

The TRB has reviewed the product chemistry data submitted for Willowood Propanil Technica! TGA! 

and has concluded that: 

1. AI! product chemistry data submitted for guideline 830 Series group A are acceptable. 

2. The proposed CSF for the basic formulation is-acceptable. 

3. The product chemistry data submitted corresponding to 830 series group B (physical-chemical 

Properties) are acceptable, except for the guideline 830.6317 (one year storage stability) 

and 830.6320 (corrosion characteristics) studie13. 

4. The registrant is advised to conducted one year'"storage stability (830.6317) & corrosion characteristic 

(830.6320) study in commercial container under· warehouse conditions. The registrant is recommended 

to make observations at 3 months intervals. The results must be submitted to the Agency 

for evaluation. 

5. The product label must be revised by replacing "Inert Ingredients" with the "Other Ingredients" under 

the Ingredient statement. 

6. Since the proposed product contains few impuri~ies which are not present in the cited product, the 

Substantial similarity could not be determined at this time. The proposed basic CSF will be routed to 

HED to conduct a qualitative structural-activity relationship (SAR) analysis for the parent & the 

impurity. Based on the HEO determination, the similarity decision will be made. 

Note: See page # 21 for the Impurity table. 

4 

*Product ingredient source information may be entitled to confidential treatment*
67

BARCODE: 0382829; Reg. No. IFILE SYMBOL No.: 87829~R; PRODUCT: WiIlowaad Prapanil Technical 

830.1550. Product identity & composition: (MRID No. 481976~01) 

Common Name: Propanil 

Chemical name (CAS): N-(3.4~dichlorophenyl)prbpanamide 

(IUPAC): 3D.4D~dicholoropropionanilide 

CAS No.: 709-98-8 

PC Code No.: 028201 

Empirical Formula: CgHgCI2NO 

MolecularWeight: 218.08 9 mar1 

Structural Formula: 

5 
68

BARCODE: 0382829; Reg. No. !FILE SYMBOL No.: 87829-R; PRODUCT: Willowood Propanil Technical 

Table 1. Manufacturing and Impurity Data for Willowood Pro ani! Technical TGAI 

GLN Requirement MRID Status DetaUs and lor Deficienc 

The NC of AI (98.5%) is supported by a 5 batch 

830.1550 Product Identity ard composirlon 481976-ot A analys'ls and agrees with the label claim. 

Imourities are listed on the CSF 

830.1600 Description of materials used to 481976-01 A The description and compos~ion for all starting 

produce the product materials was provided. 

830.1620 Description of production 48t976-01 A The product is produced in an integrated batch 

process process, and full details were provided. 

Discussion of formation of A complete discussion of the origin and 

830.1670 impurities 481976-02 A mechanisms of formation of the impurities was 

provided. 

830.1700 Preliminary analysis 48t976-02. A Five batches of product were analyzed and 

support the proposed CSF. 

The proposed certified limits for the AI are 

830.1750 Certified limits 481976-02 _. A based on standard certified limits whereas 

those of the impurities are based on the five 

batch anal sis results 

HPLC-UV was used to determine the content of 

830.1800 Enforcement analytical method 48t976-03 A AI. The method was validated for precision, 

linearitv, and accuracy. 

A = Acceptable: N = Unacceptable (see Deficiency): N/A = Not Applicable; G = Data gap; I = In progress or need upgrade: 

U = Up-Qrade additional information reauired} : 

6 
69

BARCODE: D382829; Reg. No./FILE SYMBOL No.: 8782g..R; PRODUCT: Willowood Propanil Technical 

830 Series· ) B, 

Table 2: .1 and i 

I 

~ I i 'GAl 

GLN ; MRID St,W' I i i 

830.6302 Color 481976-04 A Brownltan 

830.6303 Physical state 481976·04 A Solid 

830.6304 Odor 481976-04 A Slight 

Stability to normal and 48t976-041 

St.bI, ",,,m,1 (21'C) ,,' J(54:CI 

830.63t3 elevated temperatures, 481976-05 !WI . Waiver requested for I.'~.!, 

metals, and metal ions 

p"";" 

as the product will be packaged in 

i I . 

Oxidation/reduction: St.b" with iron, 

830.6314 chemical incompatibility 481976-04 A water, and monoammonium 

830.6315 Flammability 481976-05 W does ; 

" ; 

830.6316 Explodability 481976-05 W ; I 

l, ~s product does not have the 

830.6317 Storage stabiflty 481976-05 W ; ;;~', ; ; 

; ; '" 

830.6319 Miscibility 481976·05 W I ),ot ',' I 

II"" to b; " ; 

830.6320 Corrosion characteristics 481976-05 W Registrant ~s wi~li~g .1 i study as a 

condftion 

830.7000 pH 481976-04 A 5.39 (1% aqueous solution @25D

C) 

Wavelength; molar absorption: 

830.7050 UVNisible absorption 481976-04 A 

At pHc:2: 25t nm; E:: 21025 

AtpH7: 251 nm;E= t7894 

At PH:>10: 251 nm; E:: 19/85 

830.7100 Viscosity 481976-05 W w,;'" as product is a solid at room 

92'C 

830.7200 Melting point 48t976-0S A Citation: ; 

; ,2010, 

830.7220 Boiling point 481976-0S W W,;'" as product is a solld at room 

830.7300 Density 481976-04 A 0.769g/lat2t"C 

830.7370 ; ; constants in 481976-04 W Th, low solubiHty and is not expected to 

: wat" (DC) ; 

Log P I 

830.7S50 Partition coefficient 481976-0S A Citation: Corporation, 

; 2010. 

152 mg/l at 2S'C, experimental 

830.7840 Water solubility 481976-0S A C"";on ; 

I ; 

;;\~tI'" ' H,,, :"C, ; 

830.79S0 Vapor pressure 481976-05 A Corporation, 

I ; 2010. 

I ~~ :NC,' J;:~;~ot II :G=D"'"",:, "CO,,, 

" I, , 

7 
70

BARCODE: 0382829; Reg. No. IFILE SYMBOL No.: 87829-R; PRODUCT: Willowood Propanil Technical 

830.1800. Enforcement analytical method: (MRID No. 481976-03) 

The enforcement analytical method to determine the content of active ingredient is HPLC-UV. Sample 

chromatograms for the AI and impurities present at >0.1 % were provided. The content of the 

impurity The registrant provided the following details in MRIO 

481976-03. 

I. HPLC-UV Method for Defermination of Propanil in Wil/owood Propanil Technical 

Sample Preparation and Analysis 

Samples are homogenized by grinding the sample using the mortar and pestle prior to analysis .. 

Accurately weigh approximately 25 mg of each sample, dissolve in acetonitrile and make up to 25 mL 

w'lth the same solvent. Take 0.8 mL and dilute to 10 mL with acetonitrile for the analysis of the active 

ingredient. . 

The active ingredient was analyzed by HPLC using the following conditions: 

I 

Ilrmrumen~ 

! I Column: 

I I Mobile phwe: 

, 

I LC-20AD Sinory Puh,p~. SIL-20A Aul{);ompler~ SP().M2QA FDA Detecfor. ! C7G-2OA Column freafer, CBM·20A Communication Su~Module ond 

l DGl1-20A3DegOSler (Shimodzu) 

1 Amime HF CIS 5jl. 2..1 x250mm{Groce) 

! ACN:Woier(53:47%vjvl 

i Flowrote: 

j Injection volume: 

I 0.20 mLJmin 

I Column temp.: 

\ Detedor. I J W@210nm 

I Runtime: ! 12min 

Under the above conditions, propanil eluted at 7.77 min as shown in Figure 1. Figure 2 is a 

chromatogram of sample GAFS1012865 from the five-batch analysis. 

~r­

~l- --, ~1 

.",~~-­

,,,,,1 

~ .. 

"oJJ -It. sb 7~ ,~O"'" 

Figure 1. HPLC-UV chromatogram of propanil standard. 

8 

*Manufacturing process information may be entitled to confidential treatment*
71

BARCODE: 0382829; Reg. No./FILE SYMBOL No.: 87829-R; PRODUCT: Willowood Propanil Technical 

'. 

Figure 2. HPLC-UV chromatogram of propanil technical sample GAFS t012865. 

Calibration 

Calibration is determined using an external standard. 

a) Prepare a stock standard solution by accurately weighing approximately 10 mg 

of the certified reference standard, and dissolving it in approximately 1 mL of acetonitrile. 

Mix well and make up to 10 mL with acetonitrile to get approximately 1000 mg/L. 

b) Prepare calibration standards by diluting stock standard with acetonitrile to cover 

the expected range of sample concentrations (Table 3). Once linearity is establlshed 

(R2 ;:0; 0.995), sample solutions can be injected and peak area of chromatograms determined 

with equation 1. 

9 
72

BARCODE: 0382829; Reg. No./FILE SYMBOL No.: 87829~R; PRODUCT: Willowood Propanil Technical 

Table 3. Propanil calibration standards. 

"'op",nll sI",nd",d " N •• 

j,::" 

! 

,,-

.~o 

,~ 

Calculations and reporting 

(mg/L) (min.) (mAI,ISOC:) 

W .• 7.762 ;5788319 

71.1 7.750 6773125 

,,, 7.754 7710424 

86.3 7.777 8192086 

91.4 7.775 8640847 

101.6 7.778 9536676 

PrQPOnll. Activo 

....... _ ... .. . . . '" .. 

y B 92a28x ~ 19J?44 

R·~Q.99" . . .. 

" " " " " 

Figure 3. Propilnil standard curve. 

Equation 1: Propanil calibration equation 

y=ax + b 

Peak area = 92328x + 193944 

'" 

For the quantitation of the active constituent, a line{:lr regression of the response ratio for the sample peak 

is peliormed by the instrument control and data acquisition software. The calibration curve is accepted 

only if the correlation coefficient is equal to or greater than 0.9950 (R2;:: 9950). 

The concentration (mg/L) of propanil in the sample· solution is determined by: 

Equation 2: Concentr.ation of propanil in solution 

Propanil (mg/L) = Peak area -Intercept (b) 

Slope ral 

The concentration (%) of propanil in the sample i§determined by: 

Equation 3: Concentration of propanil in sample 

Propanil (% m/m) = Propanil Concentration (mg/Ll x 100 

Sampl~ Concentration (mg/L) 

10 
73

BARCODE: 0382829; Reg. No./FILE SYMBOL No.: 87829-R; PRODUCT: Willowood Propanil Technical 

II. HPLC-UV Method Validation for Determination of Propani/ 

Specificity 

The combination of the HPLC column, mobile phase composition and the column temperature was 

designed to ensure separation of the active ingredient from any impurities that could possibly interfere 

with the analysis of the active ingredient. The selectivity of the HPLC method was assessed by 

examination of peak homogeneity and peak purity using the diode array detector. The examination of the 

response at different wavelengths, comparison of UV spectra for the propanll reference standard and in 

samples, and the determination of peak purity showed that the analyte chromatographic peak is not 

attributable to more than one component 

Precision 

I ==== Shlmadzu LCMSsolutlon Peak Purity Report "'''" ...... 

__ 0'0>1,,_ 

()O'''''''''NOmB 

Mo'h"., /'Ilo NomB 'o'e~"~Nu"", 

O)<UOAe"" ... " 

,..... " _en""" r,,", ,1.11' Co""",",d '''''''' : "'''''''0" 

M 

0 •• 

0." 

~ 

) 

'.' M 

, c \_'\"<;T\:l._s_,o ..aGAF>.'O_20S ...... "" . :;:~.o"_nm. i.m W~;:::,\~ rr::r;;.., ; ~~."' 

,. 

_0 " 

,. 

,. 

,. 

., 0.0 

Figure 4. Peak purity report 

The Propanll standard (81.3 mg/L) solution was used to determine the instrument reproducibility. The 

standard solution was injected 7 times using the conditions as described above. The statistical analysis is 

tabulated in Table 4. The overlaid chromatogram.s,of propanil standard in seven replicates are presented 

in Figure 5. 

Table 4 HPLC-UV precision data summary 

~: 

~, 

11 
Pages 74-84-*Manufacturing process information may be entitled to confidential treatment*
85

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

211JAN!2011 

TECHNICAL REVIEW BRANCH 

SIMILARITY DETERMINATION 

MEMORANDUM 

Subject: Name of Pesticide Product: 

EPA File Symbol: 

DP Barcode: 

Decision No.: 

Action Code: 

PC Code: 

. Willowood Propanil Technical 

87829-R 

El382830 

438732 

R3l0 

028201 Propanil 

From: Rick 1. Wbiting, Biologist .•. /f- tJL::t!::.. f.l1{~ Technical Review Branch (TRB) . --j;?' 

To: 

Applicant: 

Registration Division (7505P) .' 

Mindy Ondish / Kable Davis, RM Team 25 

Herbicide Branch 

Registration Division (7505P) 

Willowood Propanil, LLC 

c/o Wagner Regulatory Associates, Inc. 

P.O. Box 640 

Hockessin, DE 19707 

FORMULATION FROM LABEL: 

Active Ingredient(s): 

028201 Propanil (CAS No.709-98-8) 

Inert Ingredient(s): 

Page 1 of2 

Total: 

%bywt 

98.5 

1.5 

100.0% 
86

) 

Propanil (PC Code 028201) 

EPA File SymhoI87829-R, Willowood Propanil Technical 

ACTION REQUESTED: The Risk Manager requests: "New registration for 98.5% Propanil 

TGAr from unregistered source. Claiming substantial similarity to Reg. No. 71085-28. Using 

cite-all method oftox data support. Please review for acceptance in support of registration." 

BACKGROUND: Willowood Propanil, LLC has submitted a Basic Formulation CSF dated 

August 13, 2010 and a proposed label to support the registration ofWillowood Propanil 

Technical, EPA File Symbol 87829-R. The registrant is claiming 87829-R is substantially 

similar to Propanil Technical, EPA Reg. NO.-71 085-28. The proposed product contains 98.5% 

Propanil while cited product contains 98.0%. The registrant is using the cite-all method of data 

support to satisfy the acute toxicity data requirements. 

COMMENTS AND RECOMMENDATIONS: 

I. TRE has compared the Basic FOlTImlation CSFs submitted for 87829-R and 71085-28, dated 

October 22, 2002, and concluded that the two products are substantially similar. , 

2. After searching the OPP electronic file database, TRE was unable to locate any previous acute 

toxicity memorandums pertaining to 71085-28 that contained an acute toxicity profile. 

Therefore, TRE cannot generate an acute toxic~ty profile for 87829-R. 

3. TRE recommends that the proposed product use the same precautionary labeling as the cited 

product. The signal word is CAUTION. 

4. The proposed Basic Formulation CSF dated August 13,2010 should be approved by the TRE 

Product Chemistry Team. 

5. This memorandum pertains only to the decision concerning whether the subject product is 

similar to the cited product from an acute toxiCological view point. For the purposes of this 

action, TRE has made no further determination of the adequacy of the toxicological database or 

the precautionary label of the cited product. 

Page 2 of2 
87

'1 ) 

UI'I,. ,,0 STATES ENVIRONMENTAL PROTEC, .IN AGENCY 

WASHINGTON, D.C. 20460 

August 30, 2010 

WAGNER REGULATORY ASSOCIATES, INC 

WILLOWOOD PROPANIL, LLC 

PO Box 640 

HOCKESSIN, DE 19707-0640 

Report of Analysis for Compliance with PR Notice 86-5 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Thank you for your submittal of 16-AUG-I O. Our staff has completed a preliminary 

analysis of the material. The results are proviqed as follows: 

Your submittal was found to be in fulr~ompliance with the standards for submission of 

data contained in PRNotice 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. 
88

481976·00 

AllgtL<'i 13,2010 

DocWllent Processing Desk (REGrEE) 

ATTN: Kathryn Montag11e, PM Team :U 

Registration Division 

Wagner Regulatory Associates, Inc. 

P.O. Box 640 

U.S. Environmel1tal Protection Agency 

Office of Pesticide programs (7504P) 

Room S·4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, Virginia 22202·450 I 

Dear Ms. Montague, 

7460 Lancaster Pike, Suite 9 

Hockessin, Delaware 19707 

Sl1 bject: Application to register a lleW technical grade pro1i11ct CO 11 tainill g a c11rrently registered active 

i11grediellt - "Willowood PrlIPll11il Techniclll" 

Wagner Regulatory Associates, Inc., as agent lor Willpwood Pmpanil, LLC (company number unassigned), is 

requesting registration of the above referenced producj. This product is substantially similar to the propanil prodllct 

(Propanil Technical) registered by RiceCo LLC under. EPA RcgistratiOll Nllmber 71085-28. 

fn support of this request, the following dOcllments and stndi.es are attached: 

.. Letter from Willowood Propanil, LLC appointing Wagner Reg11latory Associates, Inc. as its agent 

.. Application for Pesticide Registrati011 (8570·1) 

.. Confidential Statement of Fonn11la (8570-4),'2 copies 

o Certification with Respect to Citation ofDatll (8570-34) 

.. Data Matrix (8570-35) 

c Dam Transmittal Doc11ment 

c Product Identity and Composition datu (3 copics) as outlined in the transmittal document 

.. Preliminary Analysis data (3 copies) as outliried in the transmittal docllment 

.. Physical and Chemical Properties data (3 copies) as outlined in the transmittal docllment 

• Draft laheling, 3 copies and CD 

.. A copy of the EPA approved label lor EPA Reg. No. 71085-28 and 

.. A copy of the receipt confirming payment ot'the req11ired regisn'ation fees. 

Willowood Propanil, LLC has submitted payment to U.S.EPA in accordance with PRTA Jl Fee Table - FY09/FY 10, 

for action category R31 0 - $4,578, --

If you have any questions abollt this submission please contact the undersigned at Clltherine@wagnelIeg,comor 

(302) 234-2780. 

Respectrully submitted, 

Catherine M. Byrd 

Agent for Willowood Propanil, LLC 

Enclosures 
89

1. 

2. 

3. 

4. 

DATA TRANSMIITAL DOCUMENT 

Name and Address of Submitter 

WillOWQod Propanil, llC 

clo Wagner Regulatory Associates 

PO Box 640 

Hockessin, DE 19707 

Regulatory Action In Support-Of Which This Package Is Submitted 

Application for Registration 

Willowood Propanil Technical 

Transmittal Date 

August 13, 2010 

List of Submitted Studies 

------""----"Vo11: Wa~e; Regui~tory AssociateS)l;c~ (20 I 0")" Propanii Techn"icai~Product"- - - Identity and Composition, Description of Beginning Materials, Manufacturing Process, 

48197601 and Discussion of Formation oflmpurities. Willlowood USA, LLC, Roseburg, OR. 

Non-confidential portion 6 pages, Confidential portion 20 pages. 

--"'---""""-"--\;;~i. 2: Sko'Pe"C:Jana'-(2016)PreiitUfqa'ry Analyses of Five Representative··p~oductjon 

Batches ofPropanii Technical Grade Active Ingredient (TOAI) To Determine Percent 

48197602 Propanil and to Quantify Its Associated Impurities. AgriFor Scientific Pty Ltd., North 

Ryde, Australia. Report Number WW·023. Non-confidential portion 5 pages, 

Confidential portion 146 pages. 

-··---··-·--~--Vol3:"····· Skopec, Jan~(20iO) Prelinlinary Ana-lys;sof"Fi;e Rep;e~·~tatiy·e-·pro-ductio~··-­

Batches ofPropanii Teclmical Grade Active Ingredient (TOAI) To Detennine Percent 

Propanil·Ouidelines: OPPTS 830.1800 - Enforcement Analytical Method, EU 

48197603 911414/EEC, SANC0/3030/99rev4. AgriFor Scientific Pty Ltd., North Ryde, 

Australia. Report Number WW-023. Non-confidential portion 40 pages. 

-_ .. _._-..... _._-... _- ...... V 0 r4·:··-·-S·~i~&.6-;' vid (20 iO)Yh ySlcarand Ch emicaI chara(ie"f-istics··~fpro-paciT-­

48197804 

48197605 

Tech.: Color, Physical State, Odor,' Stability, Oxidation/Reduction, pH, UVNisible, 

Density and Dissociation Constanf Case Consulting Laboratories, Inc., "Whippany; NJ. 

20 pages. 

-······-V-(r5:·-····Wagn~r R·~-gulatory Ass·ociates, I~c.-·(20ToyPropaniTTechlli·c·fd - Pro·d~~-t --.... -

Chemistry Data Waivers. Willowood USA, LLC, Roseburg, OR. 4 pages. 

Company Official: 

Company Name: 

Company Contact: 

Catherine M. Byrd 

Name 

Wagner Regulatory Associates, Inc. 

Agent for Willowood PropaniL LLC 

Catherine M. Byrd 

Name 

Signature 

(302) 234-2780 

Phone 
90

PRlA 2 - 21 Day Content Screen Review Worksheet 

(EPAlOPP Use Only) 

3/23/09 

21 Day Screen Start Date: a " / C, - 10 

Experts In~Processing Signature: N E /./4/W",.,.J671"N Date li -/9 -/0 Fee Paid: Yes V 

Division management contacted on issues No Yes Date 

EPA Reg. Number: IS' 7'i; 2. 9 - 12. EPA Receipt Date: 

I 

2 

3 

4 

5 

6 

Items for Review 

Application Form (EPA Form 8570-1)(link to form) signed & complete 

including package type 

Yes No N/A* 

Confidential Statement of Formula all boxes completed, fonn signed, and XForm to 

a) All inerts (link to http://www.epa.gov/opprdOOI/inerts/).no 

including fragrances, approved for the uses (see 

Footnote 

Certification with Respect to Citation of Data (EPA Form 8570-34) (Link to 

fonm) completed and signed (N/A if 1 00% repack) X 

Certificate and data matrix consistent 

If applicant is relying on data that are compensable, is the offer 

to pay statement included. (see Footnote B) 

If IS 

completed and (N/A if source is unregistered or aplllicant 

yes no 

Data Matrix (EPA Fonm 8570-35) (Link to form) both internal and external 

copies (pR 98-5) (Link to PR 98-5) completed and signed (N/A if 100% 

Selective Method 

b) Cite~All (Fee category experts use) 

c) Applicant owns all data (Fee category experts use) 

5 Copies of Label (link to http://www.epa.gov/oppfeadlllabeling/lrmD 

x 

(Electronic labels on CD are encouraged and guidance is available)( link to '\....-

http://www.epa.gov/pestiddes/regulating/reg·lstering/submissionsflndex.htm#JabeJs /'. 

1 
91

7 Is the data package consistent with PR Notice 86-5 (link to PRN 86-5) >( 

Notice of Filing (link to 

8 http://www.cI.!a.gov/l!csticides/regulatine}tolerance l!ctitions.htm) included 

with petitions (link to \-

http://www.epa.gov/pesticides/regulating/tolerances.htm) 

9 If applicable for conventional applications, reduced risk rationale (link to )( http://www.epa.gov/opprdOOl/workplan/reducedrisk.html) 

Required Data (link to 

h ttl! ://www • CI! a.gov /(!cstici des/regula tiog/ da fa reguirements.htm) and/or 

data waivers. See Footnote C. 

a) List study (or studies) not included With application 

10 

. 

2 
92

Comments: 

~T'vt;v~ Q~ l~");'~~ QY\-~', 1\.90 ;~ V\.t s:. ~cL:v Ovvlo ~ CJc,o( ~ '1\A.u <) vJo~,,~ 

~QJ pcv.,--d ~,pprO-&b-S ~\I~ 

G-> Q).L \ ~. ~ 'e L ~ i3V\ 91v.~ r), '!. -+ I-t ) bcJ--

Q, 1-M 0 "',,;"J rr..d,,!1 

~ 1 ~><:J . 

* N/A - Not Applicable 

Footnotes 

A. During the 21 day initial content review, all CSFs will be reviewed to determine 

whether all inerts listed, including fragrances, are approved for the proposed uses. If an 

unapproved inert is identified, the applicant must either 1) resolve the inert issue by, for 

example, removing the inert, substituting it with an approved inert, submitting 

documentation that EPA approved the inert for the proposed pesticidal uses, correcting 

mistakes on the eSF, etc. or 2) provide t~e data to support OPP apPt:oval of the inert or 3) 

withdraw the application. Removing or substituting an inert ingredient will require a new 

eSF and may require submission of data. All information, forms, data and 

documentation resolving the inert issue must have been received by the Agency or the 

application withdrawn within the 21 day period, otherwise, the Agency will reject the 

application as described below. 

To successfully complete this aspect of the 21 day initial content screen, applicants are 

strongly encouraged to verify that all inert ingredients have been approved for the 

application's uses even if a product is currently registered by consulting the inert Web 

3 
93

site [link to http://www.epa.gov/opprdOOllinerts/lists.html] and ifthe inert is not 

approved, to obtain the necessary inert approval prior to submitting an application 

to register a pesticide product containing that inert ingredient. Some inert 

ingredients are no longer approved for food uses or certain types of uses. The name 

and/or CAS number on a CSF must match the name and CAS number on this web site. 

Simple typographical errors in the name or CAS number have resulted in processing 

delays. 

If an inert is not listed on the inert ingredient web site and the applicant believes that the 

inert has been approved, the applicanf should contact the Inert Ingredient Assessment 

Branch (nAB) at inertsbranch@epa.govandresolvethe issue. Copies of the 

correspondence with nAB resolving the issue should accompany the application. All 

new inerts except PIP inerts are reviewed by nAB. The nAB should also be contacted 

for any questions on what supPJrting data needs to be submitted for and the Agency's 

inert review process. Questions on PIP'inerts should be directed to the Chief of 

Microbial Pesticides Branch [Link: to 

http://www.epa.gov/oppbppdllbiopesticldes/contactsbppd.htm ]. 

When a brand, trade, or proprietary nam~ of an inert ingredient is listed on a CSF, 

additional infonnation such as an alternate name of the inert, CAS number or other 

information [link to http://www.epa.gov/opprdOOllinerts/tips.pdfJ must also be included 

to enable the Agency to detennine ifit has been approved. Each component of an inert 

mixture (including a fragrance) must be-identified. In some cases, the supplier of the 

mixture or fragrance may need to provide this information to the Agency. Prior to the 

Agency's receipt of an application, applicants must arrange with a proprietary mixture or 

fragrance supplier to provide the component infonnation to the Agency or promptly upon 

EPA's request. If the inert ingredients in a proprietary blend (including fragrances) 

cannot or are not identified or provided within the 21-day content review period, the 

Agency will reject the application. 

During the 21 day content review, applicants should submit infonnation to the individual 

identified by the Agency when the applicant is informed of an unapproved inert. 

Unapproved Inerts Identified on CSFs!'· , 

All applications except conventional new products and PIPs 

Once an unapproved inert is identified on a CSF, the Agency will contact the 

applicant with the following opti~ns: 

1. Correct the application by, for instance, correcting the inert's identity or CAS 

number, providing documentation that the inert has been approved, -or 

removing the unapproved inert from the CSF or replacing it with one that is 

approved for the application's uses; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert. If this option is selected and implemented, the Agency may 

request an extension in the PRIA decision review timeframe to accommodate 

the inert review/approval process; 

4 
94

3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of these options is selected and implemented by the applicant within the 

21 day content review period, the Agency will reject the application and retain 

25% of the full fee of the category identified. 

Conventional New Product Applications 

When the Registration Division'Identifies an unapproved inert on a CSF with an 

application for a new product that the applicant has not identified as requiring an 

inert approval (R311, R312 or R313), it will contact the applicant with the 

following options: 

1. Correct the application by, [Qr instance, correcting the inert's identity or CAS 

number, providing documentation that the inert has been approved, or 

removing the unapproved in~ from the CSF or replacing it with one that is 

approved for the application's. uses; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert, including aijy required petition to establish or amend a 

tolerance or exemption from a tolerance. (This option may change the PRIA 

category for the application, which could require a longer decision review 

time and a larger fee. If additional fees are due, they must be received by the 

Agency within the 21 day content review period.) 

3. Withdraw the application (the. Agency retains 25% of the full fee for the fee 

category estimated); or 

Ifnone of the above options is selected and implemented during the 21-day 

content-review period, the Agency will reject the application and retain 25% of 

the appropriate fee for the new pr<:>duct-inert approval category. 

PIP Applications 

When the Biopesticide and Pollution Prevention Division identifies an 

unapproved inert on a PIP CSF arid a request to approve the inert does not 

accompany the application, it will contact the applicant with the following 

options: 

1. Correct the application by, fot- instance, correcting the spelling or name of the 

inert to that in 40 CFR 174, or providing documentation that the inert has been 

approved; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert. If an inert ingredient tolerance exemption petition is 

required, the petition must be received by the Agency and the B903 fee paid 

within the 21 day period. If this option is selected and implemented, the 

Agency will discuss harmonizing the timeframe for both actions. 

5 
95

3, Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of the above options is selected and implemented during the 21 day 

content review period, the Agency will reject the application and retain 25% of 

the fee. 

B. A policy on documentation of offerS to pay is still being developed, however, for a 

me-too or fast track (similar/identical) new product, R300 or A530, an application 

without the necessary authorizations of offers to pay will be placed into either R301 or 

A531. The Agency recommends that ~uthorizations of offers to pay be submitted with 

other PRIA applications to avoid delays, in the Agency's decision, 

C. Biopesticide applicants are advised to contact the Agency and discuss study waivers 

prior to submitting their application to the Agency, Documentation of such discussions 

should be submitted with the study waiv~r, 

6 
96

6criptfor Rejection Phone C$ ,> ') , 

)1 . 

Contact Name: Co,,?e-,e~ 1 ~ 

Phone#: 30/) - ::l3~ -:l'1l?1J 

Email: co3e,<,-vi~@ 'O"8l"V!r(ocCt l<rnA. 

First Ca1J!Inmais: M, Second CallfInitials: \ 

Date: 02'/R\1co Date: ' 

Time: 161 .' d-~ PM Time: \ 

This iSL ___ J(,=_""'_"'_1Lr----i'----",%"',.?J-c·, :-Cl_O_, ---C,->' EPA contra\r. 

\ 

I'm calling regarding your submission in support of '¥ ::1/:. f? 1'2:' 'J - f!.. 

We have found tb~owing deficiencies regarding: 

PR Notice 86.5: es r No' 

Volume/Stu y Title:' to 

, S~:dt;L:, 7>()P'/Y ~,~ 

Volume/Study Title: 

9J..-o~ :It .3 ; 'Per 1t f) t Il~rc' L.-

Volume/Study Title:, , 

\ 

\ 

~~ 1: l(.' 'lbtffi, 19/ /)yJ i'N J( 1 

Additional volumes continued on back of page: Yes o@ 

Application Package: Yes o® 

These deficiencies have been approved by EPA. A.~ 7) A 

The corrections can be faxed to 703-305-5060/ Atta: _.f11>-'--~_tl: _ __t-+-O_0J_a..0 

Second CallJEmail: 

Itwe do not receive tbe'corrections by , we will process 

your, submissio}4 accordingly. Please direct all future calls and 

correspondence to the appropriate EPA Risk Manager. 
97

RE: Submission to EPA: Product Willowood Propauil Technical(Reg# 87829-R) _== __ Catherine Byrd to: Aswathy Balan~ ____ ~~~ 08/3012010 09:35 AM __ _ 

Good morning, 

I have attached the pages marked "Best Available Copy". Let me know if you 

need anything else l

. 

Thank you, 

Catherine M. Byrd 

Regulatory Associate 

P.O. Box 640 

7460 Lancaster Pike, Suite 9 

Hockessin, Delaware 19707 

P: 302.234.2780 

F: 302.234.7570 

www.wagneneg.com 

~.~~~Original Message··~~· 

From: Balan.Aswathy@epamail.epa.gov [mailto:Balan.Aswathy@epamail.epa.gov] 

Sent: Monday, August 30, 20108:01 AM 

To: Catherine Byrd 

Subject: RE: Submission to EPA: Product WiIIowood Propanil Technical(Reg# 

87829-R) 

Dear Ms. Byrd, 

The illegible pages(Vol 2, pg 144 and Vol 3, pg 40) you sent me are 

still illegible. So can you just put' Best Available Copy' on these 

pages and resend it to me. I was on leave last week on Thursday and 

Friday, so couldn't respond to you last week. Thanks. 

Aswathy Balan 

Macfadden, EPA Contractor 

2777 S. Crystal Drive, S6943 

Arlington, VA 22202 

Ph: 703~347~8787 

Fax: 703~305~5060 

From: "Catherine Byrd" <Catherine@wagneneg.com> 

To: Aswathy BalanJDCIUSEPAIUS@EPA 

Date: 08/26/201010:09 AM 
98

Subject RE: Submission to EPA: Product Willowood Propanil 

Technical(Reg# 87829-R) 

Good morning, 

I have attached the missing or illegible pages. Please letme know if 

you 

need anything else. 

Thank you, 

Catherine M. Byrd 

Regulatory Associate 

P.O. Box 640 

7460 Lancaster Pike, Suite 9 

Hockessin, Delaware I9707 

P: 302.234.2780 

F: 302.234.7570 

www.wagnerreg.com 

-----Original Message-----

From: Balan.Aswathy@epamail.epa.gov [ 

mailto:Balan.Aswathy@epamaiLepa.govJ 

Sent: Wednesday, August 25, 20IO 12:29 PM 

To: catherine@wagnerreg.com 

Cc: Nair.Sree@epamail.epa.gov 

SUbject: Submission to EPA: Product Wiilowood Pro~il Technical(Reg# 

87829-R) 

Dear Ms. Byrd, 

This is a follow-up email regarding your Application tor Registration of 

the product Willowood Propanil Technical(Reg# 87829~R). We have found 

the following defieciencies: 

Volume #2: Page I44 is illegible 

Volume #3: Page 40 is illegible. 

VoIume #4: Pages 19 and 20 are missing. 

You can send these pages either by fax to 703-305-5060, Attn: Aswathy 

Balan or email to balan.aswathy@epa.gov. If you have any questions just 

give me a cal! back at 703-347-8787. 

Thanks, 

Aswathy Balan 

Macfadden, EPA Contractor 

2777 S. Crystal Drive, S6943 

Arlington, VA 22202 

Ph: 703-347-8787 
99
100

-\ 

UNn Eb STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

August 19, 2010 

OPP Decision Number: D-438732 

EPA File Symbol or Registration Number: 87829-R 

Product Name: WILLOWOOD PROPANIL TECHNICAL 

EPA Receipt Date: 16-Aug-2010 

EPA Company Number: 87829 

Company Name: WILLOWOOD PROPANlt, LLC 

CATHERINE M. BYRD 

WAGNER REGULATORY ASSOCIATES, J;NC 

WILLOWOOD PROPANlL, LLC' 

PO Box 640 

HOCKESSIN, DE 19707-0640 

, 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

SUBJECT: Receipt of Registration Applicatiol;I Subject to Registration Service Fee 

Dear Registrant: 

The Office of Pesticide Programs has received your application 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 adminis'trative 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 COd~: R31 0 

NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT 

CHEMISTR Y;ACUTE TOXICITY;PUBLIC HEALTH PEST EFFICACY); 

) 

No additional payment is due at this time::' 

If you have any questions, please coQ.~ct the Pesticide Registration Service Fee 

Ombudsman at (703) 308-9362. 

c--;) ~ Sincerely, /PJAA- 0'fJw~ 

Front End Processing Staff 

Information Technology & Resources Management Division 
101

IFee for Servicel 

, 

(880669XThis package includes the following 

Gl New Registration 

o Amendment 

'. 

o Studies? D Fee Waiver? v . 

I D volpay % Reduction: --"-- • 

for Division 

OAD 

oBPPD 

Gl RD 

Risk Mgr. 1:1D 

Receipt No. s-I 880669 ~~~~ 

EPA File Symbol/Reg. No. ~I =8=7=8=2=9-=R~ 

Pin-Punch Date: 1 8/t6/2010 

. 

o This item is NOT subject to FFS action. 

1--!5J2:ill;~~~=~-' Parent/Child Decisions: 

Requested: I Bhi 0 11' 

Granted: I R.:?:>IO I . Amount Due: $ 4S18'£. .... 

LA-cL'e ~' .' .. .. \!i. Inert Clear d for Intend d Use Uncleared Inert in Product 

Reviewer:bf.-H-..LL44-L),At--____ _ Date: 'b[Lqlla> 

Remarks: 
102

Print Letter 

Enter More Information 

Tracking 
103

FEE FOR SERVICE 
104

Online Payment 

Step 3: Confirm Payment 

Thank you. 

Your transaction has been successfully completed. 

Pay.gov Tracking Information 

Application Name: PRIA Service Fees 

Pay.gov Tracking 10: 2519VUB1 

Agency Tracking 10: 74132224354 

Transaction Date and Time: 08/13/2010 16:10 EDT 

Payment Summary 

Address Information 

Account ~~::~ Brian Heinze 

1600 NW Garden 

Billing Address: Valley Blvd 

Billing Addre~~ Suite 130 

City: Roseburg 

State 1 Province: OR 

Zip I Postal 97471 

Code: 

Country: USA 

Account Information 

Card Type: Master Card 

Card Number: *******~****6005 

Decision 

Number: 

Registra,Uon 

Number: 

WJllowood Propanil, 

Company Name: LLC 

Company 

Number: 

Action Code: R310 

1 1213 

Payment Information 

Payment Amount: $4,578.00 

Transaction Date 08/13/2010 

and Time: 16:10 EDT 

!,! ! 

; , > > 

" . . , " ! 

" , , , 

", . , , , , ,. • • 

, " " , 

• . '.'! " 

, , , > , 

• , " > , 
105

R 310 

Must submit Group A and B product chemistry data for each proposed product. 

End Use IEP) or Manufacturing Use IMP) product or Technical Grade of the Active Ingredient ITGAI) 

EP Data MP Data 

Guideline Group A: Product Chemistry Data Submitted Submitted TGAI 

No. Study Title Yes No Yes No Yes No 

830.1550 Product Identity & Composition X 

Description of materials used to t< 830.1600 ' produce the product 

830.1650 Description of formulation process >\ 

830.1670 Discussion on the formation of impurities 1.. 

830.1700 Preliminary analysis !Z 

830.1750 Certified limits 1158.3451 !Z 

830.1800 Enforcement analytical method )( 

EP Data MP Data 

Guideline Group B: Product Chemistry Data Study ~~JJ)!~L.~~JJ)!~L.~T~G~A~I ,--_~ 

No. 

830.6302 

830.6316 

Stability to normal and 

I 

Oxidation/Reduction 

I i 

iI 

il 

Grayed out = data not required 

x 

x 

1 
106

Form Approved OMB Nos. 2070..0060; 2070-0057; 2070-0 f07; 2070-0t22: 2070-0 f64 

'A'" UNITED STATES ENVIRONMENTAL PROTECTION AGENCY \l!!fZl ,:;;I 1200 Pennsylvania Avenue, N.W. 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Norice: The pub tic reporting burden for rhis collection of information is estimated to average t.25 hours per response for registration 

and 0.25 hours per response for reregistration and speciat review activities, inctuding time for reading the instrucrions and completing the necessary forms. Send 

comments regarding burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, Collection 

Strategies Division (2822T), U.S. Environmentat Protection Agency, t200 Pennsylvania Avenue, N.W., Washington, DC 20460. Do not send the completed form 

to this address. 

Certification with Re~pect to Citation of Data 

AoolicanfsfRegistrant's Name, Address, and Telephone Number EPA Registralion Number/File Symbol 

Willowood Propanil, llC, P.O. Box 640, Hockessin, DE f9707 ..... 71;; ~q - "-

Active Inqredient(s) and/or represenlative test compound(s) Date 

Propanil August 13, 2010 

General Use Pattem(s) (list all those claimed for this oroduct using 40 CFR,~art 158) Product Name 

Terrestrial Food Willowood Propanll Technical 

NOTE: If your product is a 100% repackaging of another purchased EPA-registered product labeled for all the same uses on your label, you do not need to 

submit this form. You must submit the Formulator's Exemption Sialement (e:FA Form 8570-27). 

D t am responding to a Dala-Call-In Notice, and have included with this. form a list of companies sent offers of compensation (the Data Matrix form Should 

be used for this purpose). 

SECTION I: METHOD OF DATA.SUPPORT (Check one method only) 

D I am using the cite-all method of support, and have included with this form [2] I am using the selective method of support (or dte-all option 

a list ot companies sent offers of compensalion (the Data Matrix form under Ihe selective method), and have included with this form a 

should be used for Ihis purpose). completed list of data requirements (the Data Matrix form must be 

used). 

SECTION II: GENERAL OFFER TO PAY 

IRequired if using the cile-all method or when using the dte-all option under tI1e selective method to satisfy one or more data requirementsl 

[2] I hereby offer and agree to pay compensation, to other persons, with regard to the approval of this application, to the extent required by FIFRA. 

SECTION III: CERTIFICATION 

I certify that this application for registration, this form for reregistration, or this Data-Call-In response is supported by all data submitted or cited in the 

application for registration, the form for reregistration, or the Dala-Call-In respOnse. In add ilion, if the cite-all option or die-ali option under the selective method is 

indicated in Section I, this application is supported by all data in the Agency's ~Ies·that (t) concem the properties or effects of this product or an identical or 

substantially similar product, or one or more of the ingredients in this product-and (2) is a type of dala that would be required to be submitted under the data 

requirements in effect on the date of approval of this application if the applicalion sought the initial registration of a product of identical or similar composition and 

uses. 

I certify that for each exclusWe use study c~ed in support of this registration or reregistration, that I am the original data submitter or that I have obtained 

the written permission of the original data submitter to cite that study. 

I certify that for each study c~ed in support of this registration or reregistration that is not an exdusive use study, eilher: (a) I am tl]e'&i'gfnll dala 

submiller: (b) I have obtained the permission of the original dala submitter to use the study in support of this application: (c) all periods of eligibifilVl'or 

compensation have expired for the study; (d) the study is in Ihe public literature; or (e) I have notified in writing the company that submitted the:,~tudy and have 

offered (I) to pay compensation to the extent requtred by sections 3(c)(1)(F) andlor 3(c)(2)(B) of FIFRA; and (ii) to commence negoliations to'r!<,lef1J1fne the 

amount and terms of compensation, if any, to be paid for the use of the study .. , . ~ ~ ~ , , , , 

I certify that in all instances where an offer of compensation is requi~d, copies of all offers to pay compensation and evidence oft~f'jr,t'e~\lery in ~ , 

, accordance with sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA are available and will be submitted to the Agency upon request. Should I faiFto produce such' , ; • , evidence to the Agency upon request, t understand that the Agency may initiate action to deny, cancet or suspend the registration of my produ]l,;n ..;onformity with' r 

FIFRA. '),'; .". , , ~ ~ >! • 

I certify that the statements I have made on this fonn and all attachments to It are true, accurate, and complete. I ackno,wled9,e that any 

knowingly false or mlsleadtng statement may be punishable by fine or Imprisonment or both under appticable law. " J , > , , 

(jJJf(}){lAIDrJ I3rt r?L " Signature Date Typed or Printed Name and Tide' , , , , , 

08/13/2010 Catherine M. Byrd, Agent 

EPA Form 8570-34 (12-2003) Electronrc and Paper versrons avarlable. Subm~ only Paper version. 
107 ''"' Form A

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

""-"/ 401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Red uction Act Notice: Tile public reponing burden for this collection of infonnation is estimated to average 025 hours per response for 

honrs per response for reregistration and special review activities. including time for reading the instruction and completing the necessary fOims. Send 

burden estimate 01' any other aspect of this coilection ofinfonnation, including suggestions for reducing the burden to: Director, OPPE Infonnation Ma

U.S. Environmental Protection Agency, 401 M StTcet, S.W., Washington DC 20460. Do not send the fOim to this address. 

DATA MATRIX 

Date: 8/1312010 

Applicant's/Registraufs Name and Address: Willowood Propanil, LLC 

c/o Wagner Reg\Jlatory Associates Inc. 

P.O. Box 640 

Hockessiu,DE 19707 

Ingredient: Propanil 

Guideline Refercnce Number 1 Guideline Study Name 

PRODUCT SPECIFIC 

830.1550,830.1600.830.1650, 

830.1670, 

Prodnct identity, cOlllpositionlDescription of 

materials Used to Produce the _ . 

ProdlicUDe·s·criptibn of Fonnulation 

ProcesslDisC\lssion of FOJmation of IJI!P.!-ITities 

MRID NnmbeJ' 

EPA Reg No) File Symbol: 

Product 

Willowood Propanil Technical 

Snbmitter 

Willowood Propanil, 

, 

830.1700 I Prelimiu<lry Analysis 1 Willowood Propanil, LLC 

830.1750 I Certification ofUmits I Willowood LLC 

830.1800 I Enforcement Analy1ical Method I Willowood Prommil. LLC 

830.6302 l Color l Willowood Propanil. LLC 

830.6303 I Odor I Willowood Propanil, LLC 

830.6304 I Physical State I Willowood Propanil. LLC 

830.6313 I StabilitY to Nonnal & Elevated Temperatllfes I Wi I lowood Propanil, LLC 

830,6314 I Oxidation/Reduction I Willowood Propanil, LLC 

830.6315 I Fl<lmmability I Willowood Propanil, LLC 

830.6316 I Explodability I Willowood.propanil. LLC 

830.6317 1 Accelerated Storage Stability 1 \viliowoodPropanil, LLC 

830.6319 I Miscibility I Willowood LLC 

830.6320 I Corrosion Characteristics I Willowood Propanil, LLC 

830.6321 I Dielectric Breakdown 1 Willowood Propanil, LLC 

217

830.7000 I pH ,. WiIlowoodPro anil,LLC 830.7050 UVNisiblc Ligllt Abso ; " Willowood Pro lani!, LLC 

830,7100 Viscosity u Willowood Propanil, LLC 

830.7200 1 Melting Point 1 Willowood Propanil1. LLC 

... 

H. . ' 

Signature 

, , , , ,. 

. , , , , 

" 

EPA FOim 8570-35 Electronic and Paper versions available. Submit only Paper version, 

Name and Title 

Catherine M. Byrd, 

Agent for Willowood Propanil, LLC 
108 -"'ft" Form A

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of infonnalion is estimated to 0.25 hours per respoJise for 

hours per response for reregistration and special review activities, including time for reading tlie instruction and cOlllpletiug the nece,%ary forms. Send 

burden estimate or any other aspect of this coliectiOIJ ofiufonnation, including suggestions for reducing the burden to; Director, OPPE Infonnation Ma

U.S. Environmental ProTection Agencv, 401 M Street, S.W., Washinl!ton DC 20460. Do not send the form to this address. 

DATA MATRIX 

Date; 8(13(20 I 0 EPA Reg No.! File Symbol: ldl1f!9sigl'!ed- S7

Applicant'slRegistrant's Name and Address: Willowood Propallil, LLC Product: 

c/o Wagner Regulatory Associates Inc. 

P.O. Box 640 Willowood Propanil Technical 

Hockessiu, DE 19707 

Illgredicnt; Propanil 

GlIideliue Reference Number Guideline Study Name MRID Number Submitter 

830.72')0 Boiling Point Willowood Propanil, LLC 

830.7300 Relalive Density Willowood Propanil, LLC 

830.7370 Dissocation in Water Willowoo4 Propal)il, LLC 

830.7520 PartiCle Size, Fiber Length. and Diameter Willowood Propanil, LLC 

Distribution 

830.7550 OctanolJWater Pmtition Coefficieul Willowood Propauil, LLC 

830.7840 Solubility in Solvents Willowood Propanil, LLC 

830.7840 Wilter Solubility Willowood Pro )anil, LLC 

830.7950 Va)Or Pressure Willowood Propauil, LLC 

ACUTE TOXICITY &. Cite All Agricu Itura I Handlers Exposure 

GENERlC DATA Task Force 

Macon,MO 

Agricultural Reentry Task Force 

Waslliugton, DC 

Dow A,groscieuces LLC 

Indianapolis, IN 

Drexel Chemical Co. MC1!lphis. TN 

E.l. DuPont De Nemours and Co, luc. 

Wilmingtou, DE 

FIFRA Endangered Species Task 

Force, LLC 

Washlngtou, DC 

Nmne .. md Title 

S;"oato" Ix. &jr?!- Catherine M. Byrd, 

Agent for Willowoud hopanil, LLC 

ErA Foml 8570-35 (9-97) Electrouic and Paper versions available. Submit only Paper \'ersioJ1. 
109 $ FOITH A

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reponing tmrdcn for thi:> collection ofinformm-ion I:> estimated to average 0.25 hours per response for 

hours per response for reregistration and special review nctivities, including time for reading the instruction and completing the necessary forms. Send 

burden estimate or any other aspect of this collection ofinfonnation, including suggestions for reducing the burden to: Directl)f, OPPE Information Ma

U.S. Environmental Protection Agency, 401 M Street, S.W., WaslringtonDC 20460, Do not send the form to this address. 

DATA MATRIX 

Date: 8113/2010 EPA Reg No.1 File Symbol: B!l<lssigneci- %7

Applicant'sfRegistrant's Name and Address: \ViJlowood PropaniJ, LLC Promlct: 

clo Wagner Regulatory Associates Inc. 

P.O. Box 640 Willowood Propanil Technical 

Hockessin, DE 19707 

Ingredient: Propanil 

Guideline Referenee Number Guidelille Study Name MIUD Number Submitter 

Generic Endangered Species Task For

Gig Harbor, WA 

Monsanto Company 

Washington, D.C. 

Outdoor Residential EXjlosllre Task 

Force, LLC 

Washington, DC 

Propanil Task Force 

\Vashinoton, D.C. 

RiceCo LLC 

Memphis, TN 

Spray Drift Task Force 

Washington, DC 

United Phosphorus, Inc. King of Prussia, PA 

Footnotes: I) Certification of Limits is provided in the ConHdential Sliitement of Formnla EPA form 8574-4 

S;gnotme Ix. &friName and Title 

Catherine M. Byrd, 

Agent for WiJlowDod Propanil, LLC 

EPA Form 8570-35 (9-97) Electronic and Pilper versions available. Submit only Paper version. 
110 J''' "\:, -.nt."j. Form A

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

... 

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Paperwork Reduction Art Notice: The publi c reporting, burden for this collection of infonnation is estimated to average 0.25 hours per for 

hours per response for reregistration and special review activities, including time for reading the iustruction and completing the necessary rOmIS. Send 

burden estimate or any other aspect of this coJJection of information, including sllggestious for redncing the bU1'den to: Director, OPPE Infonnation Ma

U.S. Environmental Protection Aoency, 401 Street, S.W., DC 20460. Do not send the form to this address. 

DATA MATRIX 

Date: 8!l3!2010 EPA Reg No.! File Symbol: Unassigned- 

ApplicaJlt's/Registranl's Name and Address: WilJowood Propanil, LLC Product: 

c/o Wagner ReglllatOlY Associates Inc. 

P.O. Box 640 WiJJowood Propanil Technical 

Hockessiu, DE 19707 

Ingredient: Propanil 

---- ----- --- ------ --- ---- ------- --- --- --- ------- --- ---- --- 

Guideline Reference Number 1 GlJideJine Study Name 

Catherine M, Byrd, 

Agent lor Wilhwood Propanil, LLC 
111 ""- "" Form A

.... ,J UNITED STATns ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Paperworl, Rcdlldion Act Notice: The public reporting bnrdell for this collectian of infonmnion is estimated to average 0.25 hours per respome for 

hours per response for reregistration and special review activities, including time for readiug the iustmction aud completing the fonus. Send 

burden estimate or any other aspect of this collection ofilJformatiolJ, including sllggestious for redueing the burden to: Director, OPPE Infonnation Ma

U.S. Environmental PratecliOiI Agency, 401 M Street, S.W., Washimrt(ln DC 20460. Do not send tiJe foml to this address. 

DATA MATRIX 

Date: 8113/2010 EPA Reg No.1 File Symbol: Unassigued- 

Applicallt's/Registrallt's Name and Address: Willowood Propauil, LLC Product 

c/o Wagner Regulatory Assoc.iates Inc. 

P.O. Box 640 Willowood Propallil Technical 

Hockessin, DE 19707 

lllgrcdient: Propanil 

Jnc. 

S;goat"" &fi7LName and Title 

Catllerine !vI. Byrd, 

Agent for Willowood Propauil, LLC 

EPA FonlJ 8570-35 (9-97) EleclI'ouic illld Paper vcrsiolls available. Submit only Paper versiou. 
112 ./'ft,\, Form A

\'Z1ZZ) UNITED STATES ENVIRONMENTAL PROTECTION AGENCY "<"",,. 401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Papenvorl{ Reduction Act Notice: TIle public repOliing burden tor this collection of information is estimated to average 0.25 hours pel' response for 

hours pel' response for reregistration and special review activities, iucluding time for reading the instruction find completing the necessary forms. Send 

bllfden estimate or any other aspect of this collection of infonnation, including suggestions for reducing the bllfden to; Director, OPPE Information 1'v

U.S. Environmental Protection Agency, 401 M Street, S. W .. Washington DC 20460. Do not send the form to this address. 

DATA MATRIX 

Date: 8/13120 I 0 EPA Reg No.! File Symbol: Unassigned- 

Applicant's/Regisn-ant's Name aud Address; Willowood Propanil, LLC Product: 

clo Wagner Regulatory Associates Inc. 

P.O. Box 640 Willowood Propanil Technical 

Hockessin, DE 19707 

Ingredient: Propauil 

Si2!mtm., r!difu;w;w't1<-&fr1--

Name alld Title 

Catherine M. Byrd, 

Ageut for Willowood Propanil, LLC 

EPA Fonn 8570-35 Electronic and Paper versions available. Submit only Paper version. 
113

Certification with Respect to Label Integrity 

version: 9/11/02 

I certify that the infon11ation (including, but not limited to, text, tables, and graphics) 

contained in the electronic file identified below by file name and submitted with this 

certification is the same information as that on the paper copies of these documents 

included with this submission. 

IPROPOSED LABEL 

Date Submitted . 

EPA Registration # to EPA . Electronic file name 

XXXXX- 08113/2010 xxxxx-xxxxx-20100813.pdf 

I certify that the statements that I have made on this form are true, accurate, and 

complete. I acknowledge that any knowingly false or misleading statements may be 

punishable by fine or imprisonment or both under applicable law. 

Signature 

Catherine M. Byrd 

Name (typed) 

Agent for Willowood Propani!, LLC 

Title 

08/13/2010 

Date 

", , 

" , , , " . 

. , " , , 

, , , 0 

, " " , 

, , , ", , , 

", . ", , 

, . , , .. . ., , , 

, ' 

" 
114

W/L 

WIUOWOOD US_ Your preferred manufacturer of post patent products 

August 13, 2010 

To: Whom it May Concern 

Re: Designation of Agent for: 

WiJlowood Propanil, LLC 

1600 NW Garden Valley Blvd. 

Suite 130 

Roseburg. OR 97471 

Dear Sir or Madam: 

This letter serves as notification that Willowood PropaniL LLC has apPointed Wagner 

Regulatory Associates, Inc. CWRA, Inc.) to serve as the Agent on OUf company's behalf 

regarding all state and federal regulatory matters relative to products that Willowood 

PropanH, LLC will register with US EPA and1he states. Please forward all 

correspondence for our company and its products to: 

Wagner Regulatory Associates, Inc. 

P.O. Box 640 

Hockessin, DE 19707-0640 

Thank you for your time and assistance. Please feel free to call me at if you have any 

questions. 

R~SUbtm)ittfe~d~'~~'-t~~ 

Brian Heinze 

PresidentlCEO 

cc: WRA, Inc. 

)" , ),' , 

, " )) , 

, , i " , , 1600 NW Garden Valley Blvd. $uile 130 • Roseburg, OR 97471 • 541.679.9963· FAX 541.679.4650' www.Wil!owoodUSA.com 

. . ~ , . , , " , , 
115

Augus! 13, 20ID 

/Document Processing Desk (REG FEE) 

ATTN: Kathryn Montague, PM Team 23 

Registration Division 

U.S. Environmental Protectiou Agency 

Office of Pesticide Programs (7504P) 

Room S·4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, Virginia 22202-450 I 

Dear Ms. Montague, 

Wagner Regulatory Associates, Inc. 

P.O. Box 640 

7460 Lancaster Pike, Suite 9 

Hockessin, Delaware 19707 

Subject: ApplicaHonlo register a new !echnical grade prollnct coutaining a currently regis!ered active 

ingredient - "Wlllowood Propanil Technical" 

Wagner Regulatory Associates, Inc., as agent lor Willowood Propanil, LLC (company number unassigned), is 

requesting registration of the above referenced produl,-}-' This product is substdntially similar to the propanil product 

(Propanil Technical) registered by RiceCo LLC under EPA Registration Number 71085-28. 

In support of this request, the following documents and ~tudies are at!ached: 

• Letter from Willowood Propanil, LLC appointing Waguer Regulatory Associates, Inc. as its agent 

• Application for Pesticide Registration (8570-1) 

• Confidential Statement of Formula (8570-4), 2 copies 

• Certification with Respect to Cil'ation of Data (8570·34) 

• Data Matrix (8570·35) 

• Data Transmittal Docnment 

• Product Identity and Composition data (3 copies) a~ outlined iu the transmittal document 

• Preliminary Aualysis data (3 copies) as outlined in the transmittal document 

• Physical and Chemical Properties data (3 copies) a~< ouWned in the transmittal document 

• Draft labeling, 3 copies and CD 

• A copy onhe EPA approved label for EPA Reg. No. 71085·28 anci 

• A copy of the receipt confinning payment of the required registration fees. 

Willowood Propanil, LLC has submitted payment to U.S.EPA in accordance with PRIA II Fee Table - FY09/FY 10, 

for action category R31 0 - $4,578. . 

If you have any que8tions about this submission please contact the undersigned at (;gtberine@.wagnerreg.com or 

(302) 234-2780. 

Respec!fully submitted, 

Catherine M. Byrd 

Agent for Willowood Propanil, LLC 

Enclosures 
116

1. 

2. 

3. 

4. 

DATA TRANSMITTAL DOCUMENT 

Name and Address of Submitter 

Willowood Propanil, LLC 

clo Wagner Regulatory Associates 

PO Box 640 

Hockessin, DE 19707 

Regulatory Action In Support Ot.Which This Package Is Submitted 

Application for Registration 

WiUowood Propanii Technical 

Transmittal Date 

August 13, 2010 

List of Submitted Studies 

----~-~""-----"-----"-""-"c=::=c=---"--~"---"=~C"------ VoL 1: Wagner Regulatory Associate~' Inc. (2010) Propanil Technical-Product 

Identity and Composition, Description of Beginning Materials, Manufacturing Process, 

and Discussion ofFonnation of Impurities. Wililowood USA, LLC, Roseburg, OR. 

Non-confidential portion 6 pages, Confidential portion 20 pages. 

---,-_._--"- VoCz;'Si(;pec:Jana (2010) Preliminary Analyses of Five -Representative-Fi~od~ction-"-· 

Batches ofPropanil Teclmical Grade Ac.tive Ingredient (TGAI) To Determine Percent 

Propanil and to Quantify Its Associated, Impurities. AgriFor Scientific Pty Ltd., North 

Ryde, Australia. Report Number WW-023. Non-confidential portion 5 pages, 

Confidential portion 146 pages, 

-"-------'-VoL3: Skope0illla (2010) -Preihninary Anaiyse~ ofFive-Represe-nta'iive Produc'tion--

Batches ofPropanil Teclmical Grade Active Ingredient (TGAI) To Detennine Percent 

Propanil·Guidelines: OPPTS 830.1800 -'Enforcement Analytical Method, EU 

91/414JEEC, SANCOJ3030J99rev4. AgriFor Scientific Pty Ltd., North Ryde, 

Australia. Report Number WW-023. Non-confidential portion 40 pages, 

'''--'-----'''"-''"Vo1. 4: Sinning, David (2010). Physic'aran'~CChe;-r~;l'Ch'aracter~tic-;' ofPrOpa~IT-­

Tech.: Color, Physical State, Odor, Stability, OxidationlReduction, pH, UVNisible, 

Density and Dissociation Constant, Case Consulting Laboratories, Inc., Whippany, NJ. 

20 pages. ,,' , 

'" , 

--~--'---"VoC5": Wagner Regulatory Associates~ Inc. (2010) Propanil-T~chnicaC':::" Prod'uc-' -'"'"'- ;", > , 

Chemistry Data Waivers, Willowood USA, LLC, Roseburg, OR. 4 pages. 

. 

. " 

, , . , , . , " 

• 

, " , , . Company Official: 

Company Name: 

Company Contact: 

Catherine M. Byrd 

Name 

Wagner Regulatory AssOCiates, Inc. 

Agent for Willowood Propanil, LLC 

Cather'lne M, Byrd 

Name 

Signature 

1302) 234-2780 

Phone 

, 

,,) , 

> , > • , 

, • > , , -
117

Please read instructions on reverse before com-' '\I(lg fom), Form ADorov~-1" OMB No. 2070-0060. Aonrovat exnires 05-31-98 , X egistration OPP Identifier Number 

.oEM United States 

Environmental Protection Agency Amendment 

Washington, DC 20460 Other 

Application for Pesticide - Section I 

1. Company/Product Number 2. EPA Product Manager 3. Proposed Classification 

Unassigned 3 7 8J~ "72: t~a!llfYI! Merllastle JIM'TOMPt::<.nS 

4. Company/Product (Name) PM# 

Willowood Propal1il , LLClWillowood Propanil Technical 25~5 IZl None Restricted 

5. Name and Address of Applicant (/nclude Zip Code) 6. Expedited Review. In accordance with FIFRA Section 3(c)(3) 

Willowood Propanil. LLC 

(b)(I), my product is similar or identical in composition and labeling 

to: 

clo Wagner Regulatory Associates, Inc. 

P.O. Box 640 

EPA Reg. No. 71085-28 , 

Hockessin, DE 19707 Product Name: Propanil Technical 

D Chec/( if this is a new address 

Section - II 

0 Amendment - Explain below. . 0 Final printed labets in response to 

Agency letter dated 

0 Resubmlssion "in response to Agency leiter dated Il9 "Me Too" Appl'lcation. 

0 Notification - Explain below. 0 Other - Explain below. 

Explanation: Use additional page(s) it necessary. (For Section I and Section II.) 

Section - III 

1. Material This Product Will Be PackaQed In: 

Child-Resistant Packaging U~ckaging W~Soluble Packaging 2. T e of Container 5d Ye,' Ye, Ye, Metal 

X No tx No k;- No X X Plastic 

If 'Yes" No. per If "Yes" No. per Glass 

* Certfffcation must Unit Packaging wgt container Package wgt container Paper 

be submitted I Other (Specify) HOPE lined bags 

3. Location of Net Contents Information 4. Size(s) Retail Container 5. Location of Label Directiolls 

m Label D Container 551bs (25 kg) ,:- tRj 011 Label 

",. X On labeling accompanying product 

6. Manner in Which Label is Affixed to Product § Lithograph D Other 

X Paper glued 

Stenciled 

Sectfon - IV 

1. Contact Point (Complete items direct! be/ow for identificafion of-ifldividual to be contacted, if necessa . to roce~'ihts'a licafion. 

Name ) Title 1 Tell~fhone No. (Include Area Code) 

Catherine M. Byrd AQent for Wiilowood Propanil, LLC : (3022342780 > H,'" 

Certification 6. Date Appfieatlon 

t certify that the statements I have made on this form and all attachments thereto are true. accurate and complete. Received > , $ , • > • 

• , , 

I acknowledge that any knowingly ialse or misleading statement may be punishable by fine or implisonment 0) 

, , , , " , iJ , 

both under applicable law. (Stamped) > > , > > , , , 

2. Signature 3. ntle '" , " , , , 

"' . • , , > > 

Agent tor Willowood Propanil, lLC , , 

~!1l&frzl-

, > , " > • 

, ,,' . " J 

.. 4. Typed Name 8/13/2010 , ,,; , 

Catherine M. Byrd 

ThiS IS a reproduction of EPA Form 85701 - (Rev. 8~94) PrevIous editions are obsolete. 
118

b8 

or to reveal. 'other thaia;to::tti8',:s. ,,' " " ,',. ," -,,,',';'<' 

·the United 

","''',' A ' «' 

-Of to'tbe courts 'fa response;' " " '" ,,>,' 

emergencies to 

Ute of 

. ;;' >, <,;',';'''/;'>'i-,';:/','>Y';', 
Pages 119-121-*Confidential Statement of Formula may be entitled to conf