# EPA Registration 87829

‐ 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,---· ::{--'--

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# 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_~~/_{_(** 

# ____________ __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~'** 

### Kable Bo Davis

### ~ Product Manager 25 \ 

## = Date: 

## ,IUN 1 3 2011
Herbicide Branch Division (7505P)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> 

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# il!.t',:::'**~1"'2",\** - \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.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 A87829-1-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

# \



# 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

### '\ 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) 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

## ) 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 

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### r-----.,-

.. -----j---. ! Activity: ! Herbicide '-

.. ________ ._L

. __ _ Structure:**CIX)NH~** 

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### 3')
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.

### 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 3 rd 

### 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 3 rd 

### 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

Enclosures1. 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

### 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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... 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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## ,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 3 rd 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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"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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# ~:::?~~ 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.

### 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

" , 

## ,

,

, ;

### 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,

### 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

.. 

### '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)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

### 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

### 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****************************************************************************** ************************************* 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**~ ~ ~**

./

### 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.

### 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

### 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

< 

# I If 

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

### 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@EPAFrom: 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

### 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,

### !

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>

### 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

### 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 Case No.: NA Risk Assessment Type: NA TXRNo.: NA CAS No.: 709-98-8 40 CFR: 180.274 MRIDNo.: NA


### 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

### 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

## 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 of2I 

### 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

### 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

### ! 

### 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

## 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

### )

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.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.

2BARCODE: 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].

3BARCODE: 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.

4BARCODE: 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: C g H g CI 2 NO
MolecularWeight: 218.08 9 mar 1

Structural Formula:

5BARCODE: 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} :

6BARCODE: D382829; Reg. No./FILE SYMBOL No.: 8782g..R; PRODUCT: Willowood Propanil Technical

830 Series· 

### ) B, I

# ~

Table 2: .1 and 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 @25 D 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

## ~~ :N 

### C ,'

### J;:~;~ot II :G=D"'"",:, 

# "CO,,, 

# " I, 

# ,

7BARCODE: 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.

8BARCODE: 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 (R 2 ;:0; 0.995), sample solutions can be injected and peak area of chromatograms determined with equation 1.

9BARCODE: 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)

10BARCODE: 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

### 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%) 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

### '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.

### 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

### 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

## 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

### 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

### Comments:

# ~T'vt;v~**Q~ l~");'~~** **QY\-~',** 1\.9 

# 0**;~** 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

### 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

### 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

### 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

## 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 iS L ___ 

## 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(.' 

# 'lbt
ffi
, 

# 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.

### 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 AMSubject 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

### -\
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

# 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
Date: 

# 'b[Lqlla> Reviewer:bf.-H-..LL44-L),At--

____ _ Remarks:Print Letter
Enter More Information Tracking

# FEE 

# FOR SERVICEOnline 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

!,! !
; , > > 

## " 

# . . , " ! 

### "
, 

### , , 

### ", 

# . , , , , 

## ,. • •

, 

### " " 

### , •

. '.'! " , , , > , 

### • , " > ,

## 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

1Form 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.''"'FormApprovedOMBNo.UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY""-"/401MStreet,S.W.WASHINGTON,D.C.20460ReductionActNotice:Tilepublicreponingburdenforthiscollectionofinfonnationisestimatedtoaverage025hoursperresponseforreghtr,\tionactivitiesand0.25honrsperresponseforreregistrationandspecialreviewactivities.includingtimeforreadingtheinstructionandcompletingthenecessaryfOims.Sendcommentsregardingtheburdenestimate01'anyotheraspectofthiscoilectionofinfonnation,includingsuggestionsforreducingtheburdento:Director,OPPEInfonnationManagcmentDivision(2137),U.S.EnvironmentalProtectionAgency,401MStTcet,S.W.,WashingtonDC20460.DonotsendthefOimtothisaddress.DATAMATRIXDate:8/1312010Applicant's/RegistraufsNameandAddress:WillowoodPropanil,LLCc/oWagnerReg\JlatoryAssociatesInc.P.O.Box640Hockessiu,DE19707Ingredient:PropanilGuidelineRefercnceNumber1GuidelineStudyNamePRODUCTSPECIFIC830.1550,830.1600.830.1650,830.1670,Prodnctidentity,cOlllpositionlDescriptionofmaterialsUsedtoProducethe_ .ProdlicUDe·s·criptibnofFonnulationProcesslDisC\lssionofFOJmationofIJI!P.!-ITitiesMRIDNnmbeJ'EPARegNo)FileSymbol:ProductWillowoodPropanilTechnicalSnbmitterWillowoodPropanil,,830.1700IPrelimiu<lryAnalysis1WillowoodPropanil,LLC830.1750ICertificationofUmitsIWillowoodLLC830.1800IEnforcementAnaly1icalMethodIWillowoodPrommil.LLC830.6302lColorlWillowoodPropanil.LLC830.6303IOdorIWillowoodPropanil,LLC830.6304IPhysicalStateIWillowoodPropanil.LLC830.6313IStabilitYtoNonnal&ElevatedTemperatllfesIWiIlowoodPropanil,LLC830,6314IOxidation/ReductionIWillowoodPropanil,LLC830.6315IFl<lmmabilityIWillowoodPropanil,LLC830.6316IExplodabilityIWillowood.propanil.LLC830.63171AcceleratedStorageStability1\viliowoodPropanil,LLC830.6319IMiscibilityIWillowoodLLC830.6320ICorrosionCharacteristicsIWillowoodPropanil,LLC830.6321IDielectricBreakdown1WillowoodPropanil,LLC217'6QCJ-Rlpage1of3StatusNoteOwnOwnOwnOwnOwnOwnOwnOwn0","OwnOwnOwnOwnOwnOwn"'VlI'"'....vn830.7000IpH,.WiIlowoodProanil,LLCv830.7050UVNisiblcLiglltAbso; "WillowoodProlani!,LLCO'830,7100ViscosityuWillowoodPropanil,LLC830.72001MeltingPoint1WillowoodPropanil1.LLC...H..'Signature, , ,,,.., ,, ,"EPAFOim8570-35ElectronicandPaperversionsavailable.SubmitonlyPaperversion,NameandTitleCatherineM.Byrd,AgentforWillowoodPropanil,LLCOwnDate8/13/2010AgcucvIlltcrualUscConv-"'ft"FormApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinfonnalionisestimatedto0.25hoursperrespoJiseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtlieinstructionandcOlllpletiugthenece,%aryforms.SendcommentsregardingtheburdenestimateoranyotheraspectofthiscoliectiOIJofiufonnation,includingsuggestionsforreducingtheburdento;Director,OPPEInfonnationManagementDivision(2137),U.S.EnvironmentalProTectionAgencv,401MStreet,S.W.,Washinl!tonDC20460.Donotsendtheformtothisaddress.DATAMATRIXDate;8(13(20I 0EPARegNo.!FileSymbol:ldl1f!9sigl'!ed-S7eOl'1-gIPage2of3Applicant'slRegistrant'sNameandAddress:WillowoodPropallil,LLCProduct:c/oWagnerRegulatoryAssociatesInc.P.O.Box640WillowoodPropanilTechnicalHockessiu,DE19707Illgredicnt;PropanilGlIideliueReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStatusNote830.72')0BoilingPointWillowoodPropanil,LLCOwn830.7300RelaliveDensityWillowoodPropanil,LLCOwn830.7370DissocationinWaterWillowoo4Propal)il,LLCOwn830.7520PartiCleSize,FiberLength.andDiameterWillowoodPropanil,LLCOWIIDistribution830.7550OctanolJWaterPmtitionCoefficieulWillowoodPropauil,LLCOWn830.7840SolubilityinSolventsWillowoodPropanil,LLCOwn830.7840WilterSolubilityWillowoodPro)anil,LLCOwn830.7950Va)OrPressureWillowoodPropauil,LLCOwnACUTETOXICITY&.CiteAllAgricuIturaIHandlersExposurePayGENERlCDATATaskForceMacon,MOAgriculturalReentryTaskForceWaslliugton,DCDowA,groscieucesLLCIndianapolis,INDrexelChemicalCo.MC1!lphis.TNE.l.DuPontDeNemoursandCo,luc.Wilmingtou,DEFIFRAEndangeredSpeciesTaskForce,LLCWashlngtou,DCNmne..mdTitleDateS;"oato"Ix.&jr?!-CatherineM.Byrd,8!l3(20I 0AgentforWillowoudhopanil,LLCErAFoml8570-35(9-97)ElectrouicandPaperversionsavailable.SubmitonlyPaper\'ersioJ1.A?en{'.vIllt{'rnHTII<:f'C'rmv$FOITHApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreponingtmrdcnforthi:>collectionofinformm-ionI:>estimatedtoaverage0.25hoursperresponseforregistrationactivitiesand025hoursperresponseforreregistrationandspecialreviewnctivities,includingtimeforreadingtheinstructionandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinfonnation,includingsuggestionsforreducingtheburdento:Directl)f,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,WaslringtonDC20460,Donotsendtheformtothisaddress.DATAMATRIXDate:8113/2010EPARegNo.1FileSymbol:B!l<lssigneci-%78"'1tPage3of3Applicant'sfRegistrant'sNameandAddress:\ViJlowoodPropaniJ,LLCPromlct:cloWagnerRegulatoryAssociatesInc.P.O.Box640WillowoodPropanilTechnicalHockessin,DE19707Ingredient:PropanilGuidelineRefereneeNumberGuidelilleStudyNameMIUDNumberSubmitterStatnsNoteGenericEndangeredSpeciesTaskForceGigHarbor,WAMonsantoCompanyWashington,D.C.OutdoorResidentialEXjlosllreTaskForce,LLCWashington,DCPropanilTaskForce\Vashinoton,D.C.RiceCoLLCMemphis,TNSprayDriftTaskForceWashington,DCIUnitedPhosphorus,Inc.KingofPrussia,PAFootnotes:I)CertificationofLimitsisprovidedintheConHdentialSliitementofFormnlaEPAform8574-4S;gnotmeIx.&friNameandTitleDateCatherineM.Byrd,3/13/20iOAgentforWiJlowDodPropanil,LLCEPAForm8570-35(9-97)ElectronicandPilperversionsavailable.SubmitonlyPaperversion.A2:encyIntemalUseCOllYJ'''"\:,FormApprovedOMBNo.2070-0060-.nt."j.UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY...401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionArtNotice:Thepublicreporting,burdenforthiscollectionofinfonnationisestimatedtoaverage0.25hoursperforregistrationactivitiesaud025hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheiustructionandcompletingthenecessaryrOmIS.SendcommentsregardingtheburdenestimateoranyotheraspectofthiscoJJectionofinformation,includingsllggestiousforredncingthebU1'dento:Director,OPPEInfonnationManagementDivision(2137),U.S.EnvironmentalProtectionAoency,401Street,S.W.,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDate:8!l3!2010EPARegNo.!FileSymbol:Unassigned-IPageIof3ApplicaJlt's/Registranl'sNameandAddress:WilJowoodPropanil,LLCProduct:c/oWagnerReglllatOlYAssociatesInc.P.O.Box640WiJJowoodPropanilTechnicalHockessiu,DE19707Ingredient:Propanil-----------------------------------------------------------------------GuidelineReferenceNumber1GlJideJineStudyNameCatherineM,Byrd,AgentlorWilhwoodPropanil,LLC8/13/2010Ageucy""-""FormApprovedOMBNo.2070-0060i....,JUNITEDSTATnsENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460Paperworl,RcdlldionActNotice:Thepublicreportingbnrdellforthiscollectianofinfonmnionisestimatedtoaverage0.25hoursperrespomeforregisllllrionactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadiugtheiustmctionaudcompletingthefonus.SendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofilJformatiolJ,includingsllggestiousforredueingtheburdento:Director,OPPEInfonnationMauagementDivision(2137),U.S.EnvironmentalPratecliOiIAgency,401MStreet,S.W.,Washimrt(lnDC20460.DonotsendtiJefomltothisaddress.DATAMATRIXDate:8113/2010EPARegNo.1FileSymbol:Unassigued-IPage:2of3Applicallt's/Registrallt'sNameandAddress:WillowoodPropauil,LLCProductc/oWagnerRegulatoryAssoc.iatesInc.P.O.Box640WillowoodPropallilTechnicalHockessin,DE19707lllgrcdient:Propanil...p'YJnc.S;goat""&fi7LNameandTitleDateCatllerine!vI.Byrd,8/13/2010AgentforWillowoodPropauil,LLCEPAFonlJ8570-35(9-97)EleclI'ouicillldPapervcrsiollsavailable.SubmitonlyPaperversiou.A!!eIlCVIllternallJscCony./'ft,\,FormApprovedOMBNo.2070-0060\'Z1ZZ)UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY"<"",,.401MStreet,S.W.WASHINGTON,D.C.20460Papenvorl{ReductionActNotice:TIlepublicrepOliingburdentorthiscollectionofinformationisestimatedtoaverage0.25hourspel'responseforregistrationactivitiesand0.25hourspel'responseforreregistrationandspecialreviewactivities,iucludingtimeforreadingtheinstructionfindcompletingthenecessaryforms.Sendcommentsregardingthebllfdenestimateoranyotheraspectofthiscollectionofinfonnation,includingsuggestionsforreducingthebllfdento;Director,OPPEInformation1'v1anagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W..WashingtonDC20460.Donotsendtheformtothisaddress.DATAMATRIXDate:8/13120I0EPARegNo.!FileSymbol:Unassigned-1Page300Applicant's/Regisn-ant'sNameaudAddress;WillowoodPropanil,LLCProduct:cloWagnerRegulatoryAssociatesInc.P.O.Box640WillowoodPropanilTechnicalHockessin,DE19707Ingredient:PropauilSi2!mtm.,r!difu;w;w't1<-&fr1--NamealldTitleDateCatherineM.Byrd,Sil3/20lOAgeutforWillowoodPropanil,LLCEPAFonn8570-35ElectronicandPaperversionsavailable.SubmitonlyPaperversion.A2:cncvIntcnJalUscC:ony

# 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



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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. )" 

### , ),' 

## ,

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, , i " , , 1600 NW Garden Valley Blvd. $uile 130 • Roseburg, OR 97471 • 541.679.9963· FAX 541.679.4650' www.Wil!owoodUSA.com 

# . .**~** 

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## "

, ,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

### 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.



# .


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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 

### ,

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## - , • > , ,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 Plastic 

### X 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) 

### , 

## , 

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, both under applicable law. (Stamped) > > , > > , 

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## , ,

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.. 4. Typed Name 8/13/2010 

### , ,,; , Catherine M. Byrd



### - ThiS IS a reproduction of EPA Form 85701 (Rev.**8~94)** PrevIous editions are obsolete.b8ortoreveal.'otherthaia;to::tti8',:s.,,'" ",',.,"-,,,',';'<'·theUnited","''','A '«'-Ofto'tbecourts'faresponse;'" "'",,>,'emergenciestoUteof.;;'>,<,;',';'''/;'>'i-,';:/','>Y';',