# EPA Reg. No. 87283-1....**~** , 

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# / 3 29) Included inthe Submission Package, is it completely filled out and signed (boxes 1·21)?
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# ./ 27) Included in the Submission Package?

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### a Certification with Respect to Citation ofData (EPA 

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## ( PYXIS REGULATORY CONSULTING, l1'1C 4110 1361h St. NW 

### Gig Harbor, WA 98332



### COURIER DELIVERY Kathryn Montague (PM 23) Document Processing Desk (FNL 

### LBL) Office ofPesticide Programs (7504P) U.S. Environmental Protection Agency Room 8-4900, One Potomac Yard 2777 S. Crystal Drive Arlington, V A 22202 November 12, 2010 

### Phone: 253-853-7369 Fax: 253-853-5516 www.PyxisRC.com

RE: Willowood Oxytluorfen, LLC

- Wi1lowood Oxyfluorfen Technical (EPA Reg. No. 87283-1) Submission afFinal Product Labeling Dear Ms. Montague, On behalfofWillowood Oxyfluorfen, LLC please find the enclosed final product labeling for Willowood Oxytluorfen Technical. In support ofthis submission, we submitthe following documents: 1. Completed Application for Registration (EPA Form**8570~1)** 

### 2. Two 

### (2) copies ofthe Willowood Oxyfluorfen Technical final product labeling 3. Letter ofAuthorization Please feel free to contact me by phone (253)**853~7369** 

### or by email atAnn@PyxisRC.comifyou have any questions or need any additional information.

Sincerely,

# 4L1~ Ann M. Tillman

Enclosures

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### 6. Expedited Revelw. In aCCOfdance wi1h FfFRA Section 3(c)(3)

Willowood Elhofumesate, LLC IbW), my product is similar Ot identical in composition and labeling c/o Pyxis RBgul,lIory Consulling, Inc. to: 4110 1361h SI. NW EPA Reg. No. Gig Harbor, WA 98332



# . D Chllck ifthis is II new addrl}ss 

### Product Name 

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# D Amendment

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### WILLOWOOD OXYFLUORFEN TECHNICAL FOR USE IN FORMULATING HERBICIDES ONLY ACTIVE INGREDIENT: Oxyfluorfen: 2-chloro-1-(3-elhoxy-4-nitrophenoxy)-4- (trifluoromelhyl)benzene

..............................................................................98.1% OTHER INGREDIENTS

............................. h ...............................................................t.9% TOTAL.
................."."
.......................................................,,'
.....100.0% EPA Reg. No. 87283-1 EPA Est. No. 86564-CHN-001 Manufactured for: Willowood Oxyfluorfen, LLC 1600 NW Garden Valley Blvd. Roseburg, OR 97471 

### Net ContentS: Ibs.

[FON SKIN OR CLOTHING: IF IN EYES:

IF SWALLOWED

IF INHALED 

### KEEP OUT OF REACH OF CHILDREN CAUTION

FIRST AID • Take offcontaminated clothing. • Rinse skin immediatelywith plenty ofwaterfor t5 -20 minutes. • Call a Poison Control Center or doctorfortreatment advice. • Hold eye open and rinse slowly and genllywithwaterfor 15-20

minutes. • Remove contact lenses, if present, after the first 5 minutes, then

continue rinsing. • Call a Poison Control Center or doctorfortreatment advice. • Call a poison control center ordoctor immediatelyfortreatment

advice. • Have person S'IP a glass ofwater'lf able to swallow. • Do not induce vomiting unless told to do so by the poison control

center or doctor. • Do not Qive anythinQ by mouthto an unconscious person. 

## • Move person to fresh air. 

### • If person is not breathing, call 911 oran ambulance, then give artificial respiration, preferably by mouth-to-mouth, if possible.

_. '. S'3 11a 120ison control center or doctorforfurther treatment advice. Note to Ph,-:;r.::ian: -Evac'Jation ofthe stomach might be advisable. For MEDICf\.L E:ncrgencies call the National Pesticide Infonnation Center 24-hours a day at1-800-858:i3ia.l-lave the product containeror labelwithyou when calling a Poison Control Center or doctoror QOinQ for treatment. PF;.ECA,UTIONARY STATEMENTS : HhZARD ';"0 Hl:lMANS AND DOMESTIC ANIMALS CAUl·ION. -Flbrmf;.J1 if**ab3orbe~:f** through skin. Avoid contact with skin, eyes or clothing. Wash hands after handling and before eating, drinking, chewing gum, using tobacco, or using the toilet. Remove contaminated clothing and wash clothing before reuse. ENVIRONMENTAL HAZARDS This product is toxic to aquatic invertebrates and fISh. Do not discharge effluent containing this product directly into lakes, streams, ponds, estuaries, oceans or public waters unless this product is specifically identified and addressed in a NDPES permit. Do not discharge effluent containing this product to sewer systems without previously notifying the sewage treatment plant authority. Forguidance, contact your State Water Board or Regional Office ofthe Environmental Protection Agency. DIRECTIONS FOR USE It is a violation of Federal law to use this product in a manner inconsistentwith its labeling. This product may only be used to formulate end-use products with the following uses: (1) artichokes (globe), bananas, blackberry, brOCCOli, cabbage, cauliflower, cacao (Hawaii only), citrus (non-bearing), clover grown fur seed, clary sage grown for essence, coffee, conifers (seedbeds, transplants, container stock) and selected deciduous trees, corn, colton, coltonwood, eucalyptus, fallow bed (colton/soybeans), fallow land, garbanzo beans, garlic, grass seeds, guava (Hawaii only), horseradish, jojoba, mint, non-crop use on rights of way, nursery stock, onions, onions grown fn"-.. seed, ornamentals, papayas (Hawaii only), raspberry, soybeans, taro, and tree fl1 nuts and vines (which include almond, apple, avocado, beechnut, brazil nut, butternut, cashew, cherry, chestnut, chinquapin, crabapple, date, feijoa , fig, filbert, grapes, hickory nut, kiwi, loquat, macadamia nut, mayhaw, nectarines, olives, peach, pear, pecan, persimmon, pistachio, plum, pomegranates, prune, quince, walnut). (2) specific uses not listed on the MP label if the fonnulator, user group or grower has complied with U.S. EPAsubmission requirements regarding support ofsuch uses; and (3) uses for experimental purposes that are in compliance with U.S. EPA requirements. Each fonnulator is responsible for obtaining EPA registration for his own end use products. Willowood Oxyfluorfen Technical must be melted by holding at 110QC for48 hours. Do not heatabove 200 QC (product decomposes). STORAGE AND DISPDSAL Do not contaminate water, food orfeed by storage ordisposal. PESTICIDE STORAGE: Store in original container tightly closed and in a safe place. PESTICIDE DISPOSAL: Wastes resulting from the use ofthis product must be disposed ofon site or at an approved waste disposalfacility. CONTAINER HANDLING: Nonrefillable container. Do not reuse or refill this contain Completely empty liner by shaking and tapping sides and bottom to loosen clinging particles. Empty residue into processing equipment. Then dispose ofliner in a sanitary landfill or by incineration if allowed by state and local authorities. Offer the drum for recycling, ifavailable. WARRANTY STATEMENT IMPORTANT NOTICE -Seller warrants that this product conforms to the chem'lcal description and is reasonably fit for purposes stated on the label when used in accordancewith the directions and instructions under normal conditions ofuse. To the extent consistent with applicable law, neither this warranty nor any other warranty of merchantability or fitness for a particular purpose, express or implied, extends to the use contrary to label instructions, or under abnormal conditions, or under conditions not reasonably foreseeable to seller, and buyer assumes the risk of any such use. EPA approval 11-01-2010

### WILLOWOOD OXYFLUORFEN TECHNICAL FOR USE IN FORMULATING HERBICIDES ONLY ACTIVE INGREDIENT: Oxyfluorfen: 2-chloro-1-(3-elhoxY-4-nilrophenoxy)-4- (trifluoromelhyl)benzene

............................................................................... 98.1 % 

### OTHER INGREDIENTS

..............................................................................................1.90/0 TOTAL
.....................................................................................100.00/0 EPA Reg. No. 87283-1 EPA Est. No. 86564-CHN-OO t Manufactured for: Wdlowood Oxyfluorfen, LLC 1600 NW Garden Valley Blvd. Roseburg, OR 9747 t 

### Net Contents: Ibs.

IF ON SKIN OR CLOTHING: IF IN EYES:

IF SWALLOWED

IF INHALED 

### KEEP OUT OF REACH OF CHILDREN CAUTION

FIRSTAID • Take offcontaminated clothing. • Rinse skin immediatelywith plenty ofwaterfor 15 -20 minutes. • Call a Poison Control Centeror doctorfor treatment advice. • Hold eye open and rinse slowly and gentlywithwaterfor 15-20

minutes. • Remove contact lenses, if present, afterthe first 5 minutes, then

continue rinsing. • Call a Poison Control Center or doctorfor treatment advice. • Call a poison control center ordoctor immediately for treatment

advice. • Have person S'IP a glass ofwater'lf able to swallow. • Do not induce vomiting unless told to do so by the poison control

center or doctor. • Do not Qive anythinQ by mouth to an unconscious person. 

## • Move personto fresh air. 

## • If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably by mouth-to-mouth, ifpossible. • Call a poison control center or doctorfor further treatment advice. Note to Ph sician: Evacuation ofthe stomach mi ht be advisable. For MEDICAL Emergencies call the National Pesticide Information Center 24-hours a day at 1-800-858-7378. Have the product container or label with you when calling a Poison Control Center ordoctororgoing for treatment. PRECAUTIONARY STATEMENTS HAZARDTO HUMANS AND DOMESTIC ANIMALS CAUTION. Harmful if absorbed through skin. Avoid contact with skin, eyes or clothing. Wash hands after handling and before eating, drinking, chewing gum, using tobacco, or using the toilet. Remove contaminated clothing and wash clothing before reuse. ENVIRONMENTAL HAZARDS This product is toxic to aquatic invertebrates and fish. Do not discharge effluent containing this product directry into lakes, streams, ponds, estuaries, oceans or public waters unless this product is specifically identified and addressed in a NDPES permit. Do not discharge effluent containing this product to sewer systems without previously notifying the sewage treatment plant authority. For guidance, contact your StateWater Board or Regional Office ofthe Environmental Protection Agency. DIRECTIONS FOR USE It is a violation of Federal law to use this product in a manner inconsistent with its labeling. This product may only be used to fonnulate end-use products with the following uses: (1) artichokes (globe), bananas, blackberry, broccoli, cabbage, cauliflower, cacao (Hawaii only), citrus (non-bearing), clover grown for seed, clary sage grown for essence, coffee, conifers (seedbeds, transplants, container stock) and selected deciduous trees, corn, cotton, cottonwood, eucalyptus, fallow bed (cotton/soybeans), fallow land, garbanzo beans, garlic, grass seeds, guava (Hawaii only), horseradish, jojoba, mint, non-crop use on rights of way, nursery stock, onions, onions grown**fn~""",** seed, ornamentals, papayas (Hawaii only), raspberry, soybeans, taro, and tree fn

. nuts and vines (which include almond, apple, avocado, beechnut, brazil nut, buttemut, cashew, cherry, chestnut, chinquapin, crabapple, date, feijoa , fig, filbert, grapes, hickory nut, kiwi, loquat, macadamia nut, mayhaw, nectarines, olives, peach, pear, pecan, persimmon, pistachio, plum, pomegranates, prune, quince, walnut). (2) speCific uses not listed on the MP label if the formulator, user group or grower has complied with U.S. EPAsubmission requirements regarding support ofsuch uses; and (3) uses for experimental purposes that are in compliance with U.S. EPA requirements. Each formulator is responsible for obtaining EPA registration for his own end use products. Willowood Oxyfluorfen Technical must be melted by holding at 110°C for 48 hours. Do not heat above 200"C (product decomposes). 

### STORAGE AND DISPOSAL Do not contaminatewater, food orfeed by storage ordisposal. PESTICIDE STORAGE: Store in Original container tightry closed and in a safe place. PESTICIDE DISPOSAL: Wastes resulting from the use ofthis product must be disposed of on site or at an approved waste disposal facility.**~** CONTAINER HANDLING: Nonrefillable container. Do not reuse or refill this contain Completely empty liner by shaking and tapping sides and bottom to loosen clinging particles. Empty residue into processing equipment. Then dispose ofliner in a sanitary landfdl or by incineration ifallowed by state and local authorities. Offerthe drum for recycling, ifavailable. WARRANTY STATEMENT IMPORTANT NOTICE -Seller warrants that this product conforms to the chem'lCal description and is reasonably fit for purposes stated on the label when used in accordance with the directions and instructions under normal conditions ofuse. To the extent consistent with applicable law, neither this warranty nor any other warranty of merchantability or fitness for a particular purpose, express or implied, extends to the use contrary to label instructions, or under abnonnal conditions, or under conditions not reasonably foreseeable to seller, and buyer assumes the risk ofany such use. EPA approval 11-01-2010

### 41\0136
.. St NW 

## WILLOWOOD OXYFLUORFEN, LLC Phone: 253-853-7369 Gig Harbor, WA 98332 November 9, 2009 

### Document Processing Desk (COADR) Office ofPesticide

### Programs (7504P) U.S. Environmental ProtectionAgency 

### Room 8A900, 

### One Potomac Yard 2777 S. Crystal Drive Arlington, VA 22202 

### To Whom It May Concern: RE: LetterofAuthorization Fax: 253-853-5516



### Please let this 

### letter serve to notify you that Pyxis Regulatory Consulting, Inc. (contact 

### information below) is authorized to 

### represent WiIIowood Oxyfluorfen, LLC (Co. No. pending) as authorized agent before the U.S. Environmental Protection Agency in all matters regarding 

### our pesticide registrations and applications for registrations pursuant to 

### the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 USC Section 136 et seq. Direct all official 

### correspondence from EPAto: Agent: 

### Pyxis Regulatory Consulting, Inc. 41\0136" St. NW GigHarbor, W A 98332 T: (253) 853-7369 F: (253) 853-5516 

### info@PyxisRC.com Ifyou have any questions, please do not hesitate to contact me. Sincerely,

# ~~ , BrianHeinze

# ~ President Willowood Oxyfluorfen, LLC
cc: Pyxis Regulatory Consulting, Inc.

### ( ,NITED STATES ENVIRONMENTAL

# rl

.":CTION AGENCY WASHINGTON, D.C. 20460


### February 3, 2010

OPP DecisionNumber: D-426039 EPA File Symbol orRegistrationNumber: 87283-R ProductName: WlLLOWWOOD OXYFLUORFEN TECHNICAL EPA ApplicationReceiptDate: I2-Jan-20I0 EPAWaiver Request Receipt Date: 12-Jan-2010 

### EPA CompanyNumber: 87283 CompanyName: WILLOWOOD OXYFLUORFEN, LLC JANELLE KAY PYXIS REGULATORY CONSULTING, INC. WILLOWOOD OXYFLUORFEN, LLC 4110 1136THSTREET, NW GIG HARBOR, W A 98332- 

### SUBJECT: Approval of50% Small Business Waiver Request Dear Registrant: OFFlCEOF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### The Office ofPesticide 

### Programs has approved your request for 50% waiver ofthe 

### pesticide registration fee associated with the action referenced above. The decision review 

## period for this action will begin on the date ofthis 

## letter. The Action has been identified as Action Code: R31 0 NEW PRODUCT;NON-F AST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTETOXICITY;PUBLIC HEALTHPEST EFFICACy); 

## Ifyou 

### have any questions, please contact the Pesticide Registration Service Fee Ombudsman, at (703) 305-6249. 

### Sincerely,

# os~~~~ Infonnation Teclmology & 

### Resources Management Division 

## Office ofPesticide

## ProgramsI (

# ~taril:®lJital~it© 

# ft»® taldd®d tt© talO'1l**~-Jtal©jg~il:IJta1c~rett**



# . Reg.

# ~Ol"**01~1/2-** l 

# Dec 

# it**'--f2~o3q**

# DeSClrilPtion:~~_-,-N'""-Q\;Jtt;Al,l-l-\'VmL!· .4<.

# :wdut""",-~"",: _____ -_ 

# 1. : Q---iP'lacementwithinthe e-Jac!(eiljacket: «Default (chronological, top "':newest) 

# o Fils Location: (PDf page number,i,e" "before page 

# 46")

2. 9(Sendto Data IEllirlllcition contractors this materia!: 

# '5r Newlystampedaccepted label 

# o Notification ( 

# K NewCSf

# ~ 

# +oidiA·

# *'

o Other: __________**~-** 

# 3.AUacl'n tl'nis coversileet:tothetop ofthe material 01'

# jacflet. It must bewell organized aOld clipped together, NOT STAPLED. Then give the materialwith this 

# coversl'neetto staffin the iOlfonnation Services Center(Room 8-4900). 

# R 

# e'liDewer's Nam

# IS:

# ~&b"'--tha"""--i\"",Jcxu:..'t\Q .\'\-1

# ~B~e;;t.l!()-I'w,"",",,!::{,D.4---- DivisooW!J: 

# RD\H6 Date:

# ~ ________

# ~l~\~\_L\_\_O________

# ~__ __
CreatedAugust14. 2008

### U.S. ENVIRONMENTAL PROTECTION AGENCY EPA Reg. Number: Date oflssuance:**~"',,€O ST"'T~**  ... 

### Office ofPesticide Programs 

### 87283-1 

### .i**~** 

# "i

# '~-a' Registration Division (7505P) 

## :1 ClIJ - 

# \'=.;' Ariel Rios Building**+""'(PR~** 

### 1200 Pennsylvania Ave., NW Washington, D.C. 20460 

### NOTICE OF PESTICIDE, Term ofJssuancc: 

### conditional L.. 

### Registration Name ofPestieide Product:



### _ Reregistration Willowood Oxyfluorfen (undcr FIFRA, as amended) 

### Technical Name and Address ofRegistrant (include ZIP Code): Willowood Oxyfluorfen, LLC 

### 8690 

### Lookingglass Road Roseburg, OR97470 Note: Changes in labeling differing in subslanee from that acceplcd in connel:tion with thisregistration mustbe submitted to and accepted by the RegistrationDivision prior 10 uscofthe label in commerce. In any correspondcnce onthis productalwaysrefer 10 theabove EPAregistralion number. Onthe basis ofinfonnation furnished by the registrant, the above named pesticide is hereby registered/reregisJered underJhe Federal Insecticide, Fungicide and RodenticideAct. Registration is in no way to be construed as an endorsement or recommendation ofthis product by the Agency. In order to project health and the environment, the Administrator, on his motion, may at any time suspend or eanec1the registration ofa pesticide in accordance with the Act. The acceptance ofanyname in connection with the registration ofa product under this Act is not to be construed as giving the registrant a right to exclusive usc ofthe name or to its usc ifit has bccn covered byothcrs. 

### This product is registered in accordance with FIFRA provided that you: 

### I. Submit and/or cite all data required for registration review/reregistration ofyourproduct when the Agency requires all registrants ofsimilarproducts to submit data. 2. Submitthe data listed below: 

### a. Within one year ofthe date onthis registration notice, Storage Stability (830.6317) and Corrosion Characteristics (830.6320) studies must be submitted. It 

### is recommended that the observations be made at 0, 3, 6, 9, and 12 month intervals. 

### 3. Make the following label revisi.ons: a. Revise the EPA Reg. No. to read, "EPA Reg. No. 87283-1" b. Revise the First Aid section so that 'Ifon Skin orClothing' instructions are listed first

c. Perthe acute toxicity review, revise the 'Hazardsto Humans and Domestic Animals' section to read as follows: "CAUTION: Harmful ifabsorbed through skin. Avoid contact with skin, eyes or clothing. Wash hands after handling and before eating, drinking, chewing gum, using tobacco, or usingthetoilet Remove contaminated clothing and wash clothing before reuse." 

### d. Add, "(Hawaii only)" after "cacao" in the list ofuse sites. 

### Continuedonpage 2 S;","oreofApp,"';o,**Offid'~** 

# )1

# lYlonb Date: 

### Kathryn V. Montag'fjl' 

# i/1l(D Project Manager 23 

## Z**~.I(l\f** 

### ..
- i 

### Herbicide Branch RegistrationDivision (7505P) EPA Fonn 8570 6 .

### Page 2 of2 EPA Reg. No. 87283-1 Notice ofRegistration

Submit one (l) 

### copy ofthe revised final printed label for the record. Ifthese conditions are not complied with, the registration will be subject to cancellation in accordance with FIFRA sec. 6(e). Your release for shipment ofthe product constitutes acceptance ofthese conditions. A stamped copy ofthe label is enclosed for yourrecords.

### (



## WILLOWOOD OXYFLUORFEN TECHNICAL FOR USE IN FORMULATING HERBICIDES ONLY ACTIVE INGREDIENT: Oxyfluorfen: 2-chloro-1-(3-ethoxy-4-nitrophenoxy)-4-(trifluoromelhyObenzene

.................98.1 % OTHER INGREDIENTS

........................................................................................................1.9% TOTAL

..........................................................................................................100.0% 

## KEEP OUT OF REACH OF CHILDREN 

# CAUTION FIRST AID ACCEPTED with COMMENTS In EPA LetterDated:
UndertheFederal 1m ·.,(icide, Fungicide, and RodcrlilCldeAct as aml!flded, forthepeslil::ide registeredunderEPAReg. No.

IF IN EYES: • Hold eye open and rinse slowly and gentlywith waterfor 15 -20 minutes. • Remove contact lenses, ifpresent, afterthe first 5 minutes, then continue

rinsing. • Call a Poison Control Centeror doctorfor treatment advice. IFON SKIN OR • Take offcontaminated clothing. CLOTHING: • Rinse skin immediatelywith plenty ofwaterfor 15 -20 minutes. • Call a Poison Control Centeror doctorfortrealment advice. IF SWALLOWED • Call a poison control center or doctor immediately fortreatment advice. • Have person sip a glass ofwater ifable to swallow. • Do not induce vomiting unless told to do so by the poison control center or

doctor. • Do not give anything by mouth to an unconscious oerson. IF INHALED 

# • Move person to fresh air. 

## • If person is not breathing, call 911 oran ambulance, then give artificial respiration, preferably by mouth-to-mouth, if possible. • Call a poison control center or doctorforfurther treatment advice. Note to Physician: Evacualion ofthe stomach might be advisable. For MEDICAL Emergencies call the National Pesticide Information Center24-hours a day at 1-800-858- 7378. Have the product container or label with you when calling a Poison Control Centeror doctoror I going fortreatment.

EPA Reg. No. 87283-
Manufactured for. Willowood Oxyfluorfen, LLC 8690 Lookingglass Road Roseburg, OR 97470 EPA Est. No.

.,' ( ,(, 

# .

, , Net Contents: xx Ibs. , 

### " ( 

### " 

### ,

, " 

### " 

# .

Willowood Oxyfluorfen Technical Label 1

### ( 

## I 

## I

PRECAUTIONARY STATEMENTS HAZARD TO HUMANS AND DOMESTIC ANIMALS CAUTION May cause moderate eye irritation. Harmful 

### ifswallowed, inhaled or absorbed through skin. Do not get in eyes or on clothing. Avoid contact with skin, eyes or clothing. Avoid breathing vapors or dust. Wash hands after handling and before eating, drinking, chewing gum, using tobacco, or using the toilet. Remove contaminated clothing and was clothing before reuse. 

### ENVIRONMENTAL HAZARDS This product is toxic to aquatic invertebrates and fish. Do not discharge effluent containing this product directty into lakes, streams, ponds, estuaries, oceans or public waters unless this product is specifically identified and addressed in a NDPES permit. Do not discharge effluent containing this product to sewer systems without previously notifying the sewage treatment plant authority. For guidance, contact your State Water Board or Regional Office ofthe Environmental Protection Agency. 

### DIRECTIONS FOR USE It is a viotation of Federat taw to use this product in a manner inconsistentwith its tabeting. This product may only be used to formulate endwuse products with the following uses: (1) artichokes (globe), bananas, blackberry, broccoli, cabbage, cautiflower, cacao, citrus (non-bearing), ctover grown for seed, ctary sage grown for essence, coffee, conifers (seedbeds, transplants, container stock) and setected deciduous trees, corn, cotton, cottonwood, eucalyptus, fatlow bed (cotton/soybeans), faltow land, garbanzo beans, garlic, grass seeds, guava (Hawaii onty), horseradish, jojoba, mint, non-crop use on rights of way, nursery stock, onions, onions grown for seed, ornamentals, papayas (Hawaii onty), raspberry, soybeans, taro, and tree fruit, nuts and vines (which inctude almond, apple, avocado, beechnut, brazil nut, butternut, cashew, cheny, chestnut, chinquapin, crabapple, date, feijoa , fig, filbert, grapes, hickory nut, kiwi, loquat, macadamia nut, mayhaw, nectarines, olives, peach, pear, pecan, persimmon, pistachio, plum, pomegranates, prune, quince, walnut). (2) specific uses not listed on the MP labet if the formulator, user group or grower has complied with U.S. EPA submission requirements regarding support ofsuch uses; and (3) uses for experimental purposes that are in compliancewith U.S. EPA requirements. Each formulator is responsible forobtaining EPA registration for his own end use products. Willowood Oxyfluorien Technical must be melted by holding at 110°Cfor48 hours. Do not heat above 200°C (product decomposes). 

## STORAGE AND DISPOSAL Do not contaminate water, food or feed by storage or disposal. PESTICIDE STORAGE: Store in original container tightly closed and in a safe place. PESTICIDE DISPOSAL: Wastes resulting from the use ofthis product must be disposed ofon site or at an approved waste disposat facility. CONTAtNER HANDLING: Nonrefiltabte container. Do not reuse or refill this container. Completely (,', empty tiner by shaking and tapping sides and bottom to loosen clinging particles. Empty residue into' , , ' processing equipment. Then dispose oftinerin a sanitary landfill or by incineration if allowed by**st<?t!,!(~I"j~** tocal authorities. Offerthe drum for recycting, ifavailable. ' 

### " " , 

### , , , 

### , WARRANTY STATEMENT " " " , " " , tMPORTANT NOTtCE -Seiter warrants that this product conforms to the chemical**d~scliption** and is reasonably 

### fit for purposes stated on the labet when used in accordance with ,tj1,e:

### ,clirectioi.s,~~c! instructions under normal conditions of use. To the extent consistent with**apptical?~e;** lay

.., neither**~his** warranty nor any other warranty of merchantability or fitness for a particular purpose, express or i,mpliEld, extends to the use contrary to tabet instructions, or under abnormat conditions, or under**conditi~JI,~ ',lJ~**  reasonably foreseeable to seller, and buyer assumes the risk ofany such use.

Willowood Oxyfluorfen Technical Label 

### 2

### ! , 

# NOTE TO FILE

Date: September 27, 2010 EPAFile Symbol: 87283-R 

### Product Name: Willowood Oxyfluorfen Technical Original ApplicationDated: January 12, 2010 Renegotiated Date: November 2, 20I0 

### Action Description: NewManufacturing Use Product (Oxyfluorfen) for several crop use sites Comments: 

### PRODUCT CHEMISTRY:

- Basic CSF dated Dec, 28, 2009 was found acceptable by TRB



### - Group A and Group B product chemistry data submitted were fOWld 

### acceptable with the



### exception ofStorage Stability and Corrosion Characteristics

- TRB also noted an impurity ofunknown

### toxicity in the review dated June 21, 2010 -HED was 

### then consulted for an impurity review and the impurity identified is not

thought to be oftoxicological 

### concern (memo dated September 23, 2010) 

### ACUTE TOXICITYREVIEW: Signal Word: CAUTION TRB found this productto be substantially similarto EPA Reg. No. 11603-29 

### DATA COMPENSATION: Cite-all with offer to pay companies on the Data Submitter's list for Oxyfluorfen generic 

### data and acute toxicity data. Product specific studies were submitted and found acceptable. LABEL REVIEW: 

### revisions per the acute toxicity review add "(Hawaii only)" after "cacao" to match label ofthe 

### cited substantially similarproduct

### #87283-R P.C. Codell1601



### UNITED STATES ENVIRONMENTALPROTECTIONAGENCY WASHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTIONPREVENTION TECHNICAL REVIEW BRANCH SIMILARITY CLINIC DETERMINATION MEMORANDUM 

## 221APRILl2010 

### Subject:

From:



### To:

Applicant: 

### EPA Reg. No.: 87283-R Willowood Oxyfluorfen Technical DP Barcode: 373547 

### Decision: 426039 P.c. Code 11601 Action Code: 

### II 160

### I Masih Hashim, Toxicology Team Leader

# fo{i~ 

# 0 / Technical Review Branch

# ~ 

# 0....-JL--::. Registration Division (7505P) 

### 1\ ""'-- \
. 

## V/o -1 .... l«:> 

### BethanyBenbow, RM Tearn 23 

# 't
- Herbicide Branch Registration Division (7505P) Willowood OxyfIuorfen, LLC Roseburg, OR 97470 'L-(,..

-**~**



### FORMULATION FROM LABEL: 

### Active Ingredient(s): OxyfIuorfen 

### Inert Ingredient(s)/impurity:

1 

### Total: % bywt. 

### 98.1**~** 

### 100.0

### #87283-R p.e. 

### Code 111601



### ACTION REQUIRED; To determine ifthe cited and proposed products (#11603-29 and #87283-R) are similar. 

### RECOMMENDATIONS: The cited and proposed products are substantially similar. The acute toxicity profile for EPA Reg. No. #87283-R is as follows: acute oral toxicity IV 

### cited 44712010 

### acute dermal toxicity 1lI cited 44712011 

### acute inhalation toxicity IV cited44712012 

### primary eye irritation IV cited44712013 

### primary skin irritation IV cited44712014 

## dermal sensitization neg cited 44712015

LABEL REVIEW SYSTEM 

### ID #87283-1 Willowood Oxyfluorfen Technical SIGNAL WORD: CAUTION PRECAUTIONARY STATEMENTS: 

## Harmful ifabsorbed 

## through skin. Avoid contact with eyes, skin or clothing. STATEMENT OF PRACTICALTREATMENT (SOPT): 

### IF ON SKIN: Wash with plenty ofsoap and water. Get medical attention. The following statement should occur underthe heading USER SAFETY RECOMMENDATIONS: 

### Wash hands before eating, drinking, chewing gum, using tobacco or using the toilet. The Registrant has the option ofusing 

### Toxicity Category III precautionary and first aid statements to address other exposure routes.

2

## ( 

## PYXIS REGULATORY CONSULTING, INC. 4110 136th St. NW Gig Harbor, WA 98332



### OVERNIGHT DELIVERY Katherine Montague (PM 23) Document Processing Desk (REGFEE) Office ofPesticide Programs (7504P) U.S, Environmental ProtectionAgency Room S-490D, 

### OnePotomacYard 2777 S. Crystal Drive Arlington, VA 22202 

### RE: Willowood Oxyfluorfen, LLC January 12, 2010

Willowood OxyfluorfenTechnical (EPA File Symbol 87283- ) Applicationfor NewPesticide Registration DearMs. Montague, 479606-00 

### Phone: 253·853-7369 Fax: 253-853-5516 www.PyxisRC.com



### On behalf of Willowood Oxyfluorfen, LLC, we are submitting an application for registration of Willowood Oxyfluorfen Technical, a technical containing the active ingredient Qxyfluorfen. In support of this application, we submitthe following documents: .,' ( 

### 1. Application for a NewPesticide Registration (EPAForm 8570-1) ,., 

### , 2. Confidential StatementofFormula(EPAForm 8570-4) 

### " , 

### 3. Three (3)Copies ofthe Proposed Labeling 4. A CD containing an electronic version ofthe proposed labeling 5. Certification with Respectto Label Integrity 6. Certification with Respectto Citation ofData (EPA Form 8570-34) 7. Agency Internal UseCopy ofthe DataMatrix 8. PublicFile Copy ofthe Data Matrix 9. Documentation ofSmall Business for PRlA fee reduction 10. Copy ofPRIApayment 11. Letter ofAuthorization 12. Product Specific Data (3 copies ofeach report):

Volume 

### 1 830.1550,830.1600, Tillman, A. M. Product Identity and Composition, Description of 

### 830.1620,830.1670, th, Materials Used, Description 

### of the· Production Process, 

### 47960601 830.1750,830.1800 Discussion of the Fonnation of Impurities, Certified Limits, and Enforcement Analytical Method for Willowood Oxyfluorfen Technical. COlliaillS ConfidentialBusinessInformation,

### 47960602 Volume 2 830.1700,830.1800

Volume 3 830.6302,830.6303, 

### 830.6304,830.6313, 

### 47950603 830.6314,830.7000, 830.7050,830.7200, 

### 830.7300 Volume 4 830.6313,830.6315, 830.6316,830.6317, 830.6319,830.6320, 

### 830.6321,830.7100, 830.7220,830.7370, 

### 47960504 830.7520,830.7550- 7570,830.7840- 7860, 830.7950 

### ( K. Montague Jan. 

### 12,2010

Page 2 of2 

### Lawrence, Q. A. Group 

### A Product Chemistry Analysis of 

### Oxyfluorfen Information. Technical. Contains COlljidellfial Business 

### Lawrence, Q. A. 

### Group B - Physical and Chemical Properties Testing ofOxyfluorfen Technical.

Tillman, A. M. Willowood Oxyfluorfen Technical Waiver Request for Physical and ChemicalProperties.



### We would like to note thatWillowood Oxyfluorfen, LLC is using the cite-all within the selective method ofsupport. As per EPA's interpretations of40 CFRParts 152.86(b)(2)(i) and 152.93(b)(2)(i), Willowood 

### Oxyfluorfen, LLC submitted notices of intent to apply and offers to pay to all companies on the September 30, 2009 Data Submitter'S 

### List. This action falls under PRIA category R310 (46: New manufacturing use product) because 

### it is an application for registration for a technical product identical to 

### a currently registered product. The fee for this action is $4,578, but Willowood Oxyfluorfen, LLC is requesting a 50% PRIA fee reduction to $2,289. Documentationto support eligibility as a small business is enclosed. ThePRIA fee has beenpaid. The decision tirneline is 6 months. 

### We trust you will find this application complete. However, please feel free to contact me «253)**853~** 

### 7369, Ann@PyxisRC.com) 

### ifyou have any questions or need any additional information. Sincerely,

Ann 

### M. Tillman

Enclosures

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

MEMORANDUM Date: September23, 2010 OFfiCEOF CHEMICAL SAFETYAND POllUTION PREVENTIDN



### Subject: Oxyfluorfen. EPAReg. No. 87283-R. Impurities Discussion for New 

## Formulation.

PC Code: 111601 "Decision No.: 426039 Petition No.: N/A RiskAssessment Type: N/A 

### TXRNo.:N/A MRID No.: N/A


### From: Christine Olinger, Chemist RiskAssessmentBranch VII / Health Effects Division (750 P DP Barcode: D379653 Registration No.: 87283-R RegulatoryAction: New Registration 

### Case No.: N/A CAS No.: 42874-03-3 40 CFR: 180.381



### Through: Richard Loranger 

# 1<, / rfUf/lA-I11!J'U 

### Health Effects Qivision (7509P) L---V

## ~"if 

# ' / 

### And Michael S. Metzger, Chief

# i/uJ 0 

# P

# ~ RiskAssessment Branch

## VII

## {,,~~ ((.. ( "'" Health Effects Division (750 P)

To: Bethany BenbowlKathrynMontague 

## Herbicide Branch Registration Division (7505P)


### I. 

## Action Requested Willowwoodhas proposed registration ofa teclmical grade (TGAI) product ofoxyfluorfenthat has a different impurityprofile from the currently registered TGAI. The Registration Division

Page 

### I of2

### (RD) has requested HED comment on an impurity and itspotential effects onthe toxicity ofthe TGAI. 

### II. HED Conclusions Based on a review ofthe toxicitydata for theparent compound, and a structure activity relationship analysis (SAR) oftheparent and the impurity, HED does not believe thatthe new TGAI would have a different toxicityprofile than the currently-registered TGAI. Considering the level ofthe impurity thatwould bepresent, HED has no further concerns. A detailed discussion ofthetoxicity and analysis may be found inthe Confidential Appendix to this memorandum. The confidential statementofformuIa should be amended to correcta typographical error, also noted inthe confidential appendix to this review. Attachments: Confidential Appendix



### Page 2 of2

### Confidential Appendix to D379653 Impurity Description The Registration Division inquired about one impurity inthe proposed confidential statement of formula for EPAreg. no. 87283-R atanuppercertified limit of The chemical structure of theparentcompound and the impurity may befound inTable 1below. Table 

### 1. Oxyfluorfen 

## Nomenclature. Chemical structure 

# fro

,

# ~o**~** w..... 

# , II 

# ( °

Common name Oxyfluorfen CAS Name 42874-03-3 CAS 

### registry number 

### 2-Chloro-l-(3-ethoxy-4-nitrophenoxy )-4-trifluoromethy1 benzene ImpurityNo.1

Hazard Characterization Reference: F. Fort, DP Barcode D281831, 4/29/02 

### Oxyfluorfen is oflow acute toxicity and is intoxicity category IV for acute oral, dermal, and inhalation toxicity. 

### Itis a slight eye and dermal irritantand is not a dermal sensitizer. Toxicity was similar for subchronic and chronic rat, mouse, and dog studies in both sexes. Although oxyfluorfen inhibits heme synthesis, the resulting anemia was generallymild. A microcytic anemia with a decreased hematocrit, small erythrocytes, and nonnal red blood cell count was described inthe 1997 subchronic ratstudy withthe current 98%registration. In other words, the red blood cell count was nonnal inthis study, butthe red blood cell mass was decreased because ofthe small size ofthe red blood cells, presumably because ofinhibition of theprotoporphyrinogenoxidase enzyme. The anemiawas generally mild in other studies, with varyinghematologic abnonnalities described in therat, mouse, and dog studies.

Pagelof2

# ~

### Confidential Appendix to**D37~653** 

### Mild liver toxicitywas observed inthe 1997 subchronicrat study. Increased liver weight was accompanied by very slightincreases inliver enzyme activities andminimal microscopic changes. Similar effects also occurred inthe other subchronic and chronic rat, mouse, and dog studies. There weretypically fewhistopathological lesions seen intheliver, although hepatocyte necrosis did occurinthe mouse and dog studies. Renal toxicitywas most severeinthe 2- generation reproduction study inrats, inwhichpelvic mineralization occurred. Other subchronic and chronic rat studies had otherindications ofrenal toxicity, increases in organ weightand occasional histopathological observations. Treatmentrelated mortality occurred in the subchronic mouse study, the reproduction study, and developmental studies inrats and rabbits. Other toxicological changes includedexcessive lacrimation inthe chronic dog study and increases in urine volume and water consumption inthe subchronic rat study. Developmental studies withthe current 98% technicalmaterial found no developmental toxicity inrats whereas anincrease in lateresorptions occurred intherabbit study (principally in 1litter). All genotoxicityassays were negative, except for oneAmes assay which was positive only at high, insoluble levels. A subsequentAmes assay with 96% material was negative. Oxyfluorfen is classified as a category C, possiblehuman carcinogen based upon combined hepatocellular adenomas/carcinomas in the mouse carcinogenicity study. The CancerPeer Review Committeerecommended a linear, lowdose extrapolationfor humanrisk assessments, with a Q1

# * of7.32x 10.2 

### (mglkg/day)"l inhumanequivalents. 

### HED Conclusions 

### Inreviewthe toxicity for the impurities identified, a qualitativetoxicityprediction tool (DEREK V. 11) was used to screen for potential hazards notincluded intheparent compound. As a positive control, the DEREKmodel wasrun forthe parent oxyfluorfen. A summary ofthe alerts found for oxyfluorfenand its impurity maybefound in Table 2. Based onthe DEREK analysis, plausible carcinogenicity and hepatotoxicity alerts werereported for the parent andthe impurity. These alerts are consistentwith the effectsnoted 

### inthe toxicity database. Given the structural similarityto theparent and the relatively low amount ofthe impurity inthe formulation, itis unlikelythatthe impuritywould have anappreciableeffect onthe toxicity.



### YES

Note: Theregistrant should amendthe confidential statement offormula to correctthe chemical name ofthe impurity; the chemicalname for the impurity is missing a designation ofthe nitrophenoxy group. According to the discussion ofthe formation ofimpurities onpage 19 of theproduct chemistry review ofthe technical (H. Mukhoty, D373545, 6/2111 

### 0), the nitrophenoxy isDATE OUT: SUBJECT:

FROM:

TO: 

### ( 

# fEE
211 JUNE 12010 PRODUCT CHEMISTRY REVIEW OF MP [X

## 1 EP [ 

## 1 DP BARCODE No.: 0373545 EPA File Symbol No.: 87283-R PRODUCT NAME: Willowwood Oxyfluorfen Technical COMPANY: Willowwood Oxyfluorfen, LLC FOOD USE 

### [X 1 INTEGRATED FORMULATION 

### [Xl pee: 111601 Decision No. 426039 ACTION CODE: R310

### ~**~** 

### j 

# 0 ()

.. 0\ '2-

# ~I 

# ) Har; Mukholy •

# (21**\01"~** Product Chemistry Team • 

## "j Technical Review Branch 

### I RD (7505P) Bethany Benbow 

### I Kathryn Montague, RM 23 

### Herbicide Branch 

### I RD (7505P) INTRODUCTION:


### The Registrant has submitted a CSF (dated 12/28/2009) 

### for a proposed MUP, and has also proposed a product specific proposed label (dated 01/12/2010) for registration ofthe aforesaid product under EPA File symbol 87283-R. The product chemistry data have been submitted under MRIOs: 479505-01 through -04. The aforesaid MUP is manufactured 

### by Zhejiang Chemical Company in China. Label text indicates that this proposed MUP is intended to be formulated into end-use products with food uses. The applicant claims that the proposed product is substantially similar to another registered product EPA Reg. No. 11603-29 (Product name: Oxyfluorfen Technical). The cited product was conditionally registered on 

### 10/15/1999. The product chemistry data for the cited productwere reviewed and were found to be acceptable on 

### 04/04/2005. The product specific label was accepted on 

### 06/28/2006. TRB has been requested to evaluate the product chemistry data required for the registration of the proposed MUP and to determine ifthe proposed product is substantially similar to the cited product.


### SUMMARY OFFINDINGS: 1. The proposed MUP contains the active ingredient: Oxyfluorfen (98.1%). 2. The overall mean ofthe active ingredient from the five batch analysis is 98.08 [MRID: 479505-02, Page 13]. 3. The proposed nominal concentration of the active ingredient in the MUP is 98.1 %. The nominal concentration ofthe active ingredient matches with the label claim. This is in compliance with PR Notice 91-2. The certified limits of the active and inert ingredients comply with 40 CFR 

### § 158.350 (b) (2). 4. The CSF ofthe proposed MUP is filled out completely and correctly. This CSF has been reviewed by 

### I.I.A. Branch on 

### 06/21/201 

### O.

1

### • DP BARCODE No.: 373545 EPA File Symbol No.:**87283~R** PRODUCT NAME: Willowwood Oxyfluorfen Technical 5. The product chemistry data submitted for Group A corresponding to guidelines 830.1550 (product identity and composition), 830.1600 (description of materials used to produce the product), 830.1620 (description of production process), 830.1670 (discussion offormation of impurities), 830.1750 (certified limits) satisfythe product chemistry data requirements of40 CFR §158.320, 158.325, 158.330, 158.340, and 158.350 respectively forthe proposed formulation [MRID:**479505~01** [. 6. The active ingredient and the associated impurities were quantified by GC/MS method using both the EI and +CI modes. NMR was used to qualify the commercial standard of oxyfluorfen used. A Karl Fischer titration was performed to determine the amount ofwater in each batch ofthe five batch analysis. The method validation was achieved by generating specificity, accuracy, linearity and precision data under the specified analytical conditions [MRID:**479505~02J.** Similaranalytical techniques can also be applied for EnforcementAnalytical Method. 

### 7. The product chemistry GroupA and Group B data, with the exception of one yearstorage stability (830.6317) and corrosion characteristics (830.6320) studies are satisfied [MRID:**479505~01** through**~04J.** 8. The registrant did not certify the toxicological significance ofthe associated impurities present in the proposed MUP. The proposed MUP contains a new possible isomeric associated impurity compared to the associated impurities contained by the cited product (see table of impurities comparison of this review in, pages 21-22 of this review).
CONCLUSIONS:
1. TRB has reviewed the CSF for the proposed MUPand has found it to be acceptable. 2. Product chemistry data requirements for GroupA and Group B, with the exception of one yearstorage stability (830.6317) and corrosion characteristics (830.6320) studies are satisfied and acceptable. 3. HED shall evaluate the toxicological significance ofthe new impurities present in the proposed MUP. TRB will make decision regarding substantial similarity following HED's decision

.

2

### ( 

## (

DP BARCODE No.: 373545 EPA File Symbol No.: 87283-R PRODUCT NAME: Willowwood Oxyfluorfen 

### Technical
PRODUCT CHEMISTRY DATA (SERIES 830 Group A)

Group A Data Required MRID No. 

### Fulfilled 830.1550. Chemical Identity (same as in Product CSF A 

### 479505-01 dated 12/28/2009) 

### 830.1600. Beginning Materials A 

### 479505-01 830.1620. Production process A 

### 479505-01 830.1650. Formulation process 

### N/A 830.1670. Discussion of Impurities A 

### 479505-01 830.1700. Preliminary Analysis A 

### 479505-01 830.1750. Certified Limits (same as in Product CSF dated A 

### 479505-01 12128/2009) 

### 830.1800. Enforcement Analytical Method A 

### 479505-01

A = 

### Acceptable **N/A** = 

### Not applicable

3

## ( (

DP BARCODE No.: 373545 

### EPA File Symbol No.: 87283-R 

### PRODUCT NAME: Willowwood Oxyfluorfen Technical

Group - B Data Value or Qualitat. MRID No. Reguire Descrip. 

### Q Fulfilled 

### 830.6302. Color A Light yellow 

### 479505-03,

- 04 830.6303. Physical State A Solid Powder " 

### 830.6304. Odor A Odorless 

### " 830.6313. Stability to normal and elevated A Stable at normal 

### & 

### " temp, metals and metal ions. (requesting elevated temp. waiver because test substance will not be in temp. contact with metal 

### & metal ions) 830-6314. Oxidation/Reduction 

### action- A No apparent 

### " Chemical incompatibility reaction 830.6315. Flammability 

### N/A Solid " 830.6316. Explodability 

### A Not explosive 

### " chemicals. 830.6317. Storage stability G " 830.6319. Miscibility N/A Solid 

### " 830.6320. Corrosion Characteristics G Not corrosive " 

### 830.7200. Melting point A 84.9 to 85.8 0 C " 

### 830.7220. Boiling point N/A 

### " 830.7050. UV/visible light absorption A The molar " absorption coefficient in neutral solution was 6164.5 @ 54 nm, in basic solution was 6369.2 @75nm 

### & in aCidic solution was 

### 6369.2 @54 nm respectively. 

### 830.7100 Viscosity N/A 

### "
4

# (

830.7370. Dissociation Constant A 

### No functional group " 

### to dissociate 830.7550. Partition Coefficient A 

### Log Kow

## =4.47 

### " 830.7950. Vapor Pressure A 

### 0.0267 mPa 250 

### C " 

### 830.7840. Solubility A In water 

### = 0.116 

### " **mg/L,** , In acetone 

## = 72.5 g/1

### 00 g, 

### In isophoron 

## = 61.5 g/100 g, 

### In dimethylformamide 

### > 50 g/100 g 

### 830.7000. pH A 

### 5.70 " 

### 830.7300. Density A 

### Bulk density

## = " 0.5795 g/mL 

### Explanations: A = 

### Acceptable, 

### N/A;::; Not applicable, G = 

### Data gap

5

## ( 

## (
DP BARCODE No.: 373545 EPA File Symbol No.: 87283-R PRODUCT NAME: Willowwood Oxyfluorfen Technical CONFIDENTIAL APPENDIX Product identity 

### & composition (830.1550)

OPPTS GUIDELINE

### No. 830.1550: PRODUCT IDENTITYAND COMPOSITION 

### Willowood Oxyfluorfen Technical contains 98.1% 

### oxyfluorfen. Chemical Code 111601 (CAS No. 

### 42874-03-3). The CAS nomenclature is 2-chloro-l-(3-eth9xy-4-nitrophenoxy)-4- (trifluoromethyl)benzene. The lUPAC name is 2-chloro-a,ct,ct-trifluoro-p-tolyl**~--ethoxy-4-nitrophenyl** 

### ether. Willowood Oxyfluorfen Technical is substantially similar to Agan Chef. Mfg., 

### Ltd. Galigan Oxyfluonen Technical (EPA Reg. No. 11603-29). i I 

### The molecular formula for oxyfluorfen is Cls

### HII

### CIF)N04 

### and it 

### has a**molE~culaT** 

### weight of 361.7. Its structural formula is shown below:


## c 

# ° 

# '\ CF, 

# I 

# '\

NO, 

### Oxyfluorfen Oxyfluorfen is a diphenyl ether herbicide. It is selective contact herbicide which is absorbed by the foliate. Oxyfluorfen inhibits photoporphyrinogen oxidase and controls annL:al broad leaved weeds and grasses in a wide variety ofcrops by pre- orpost-emergence application.

. The detailed composition ofWillowood Oxyfluorfen Technical is presented on a'Confidential Statement of Formula, EPA Form 8570-4, which has been removed to the Confidential Attachment at Cross Reference Number I.

6Bethany, 

### RE: 87283-R (Willowood Oxyfluorfen Technical) Ann Tillman to; Bethany Benbow

willowood Oxyfluorfen LLC agreed to the PRIA extension. Ann 

### Ann 

### M. Tillman Pyxis Regulatory Consulting, Inc. 4110 136th St. NW 

### Gig Harbor, wA 98332 Office: (253) 853-7369 Fax; (253) 853-5516 

### Ann@PyxisRC.com -----Original Message----- 06/30/2010 06:54AM

From: Benbow.Bethany@epamail.epa.gov (mailto:Benbow.Bethany@epamail.epa.gov] Sent: Tuesday, June 29, 2010 8:30 AM To: Ann Tillman Subject: 87283-R (Willowood Oxyfluorfen Technical)
Dear Ms. Tillman, It has come to my attention that this proposed MUP (Willowood 

### Oxyfluorfen Technical) contains a new impurity in which the toxicological significance is unknown. In cases such as this, the Health Effects Division will need to evaluate the impurity profile to determine if the unknowns are of toxicological concern. As such, the PRIA date will need to be extended to 90 days beyond the original due date to allow for HED's review. The new due date would be November 2, 2010 (90 days beyond Aug. 2, 2010). Please let me know if you agree to this renegotiation. Regards, Bethany R. Benbow, M.S. Biologist Herbicide Branch Registration Division, Pesticide Programs office of Chemical Safety and Pollution Prevention u.s. Environmental Protection Agency office: (703) 347-8072

### (

•Form Approved OMB No.**2070~060** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 MStreet, S.W. WASHINGTON, D.C. 20460 PIlPOI'Wllri< RoducUon Act NotlclI: The public reporttng bl.l"d!lo for this collection ofinformation is estimated to averoge 1.25 hours peffesponse for registraUon and 025 hou(1; per response for reregislfllUon 3I1d special review activitieS. induding time for reading the i-lstructions and almpteting the**neoess~ry** forms. Send commenls regarding b.mleneslimale orany otherasped ofthis colledion oflnfolmatlon, including suggestions forreducing tie bll"den 10: Diredor, OPPE InfOlmation Man:gement Division (2f37), U.S. Environmentat Prolection f./JenC)',**~Ot** M**St~t.** S.w., Washington. DC 20400. Do not send lhe completed form to ttis address. Certification with Respectto Citation of Data Adplicanl'sJRegislranfs Name. Mdress, and Te1edhone Number EPA Regil;!lation Number/File Symbol Willowood OXyfIuorlen,llC r)o Pyxis Rll\lulatory 4 t10 t36th SI. NW Gig Harbor, WA 98332,253J:i 87283 AdiVe Indredionifsl an&orrepresentative lest comooundfsl Oxyfluorlen 

# ,,>I,

Genir.ll Use**Pa~em'sl** (list al those dalmed forthls drodud usind 40 CFR Part 1581 TOAt Produd t>tIme Willowood Oxyfluorlen TecmtCilI NOTE: Ifyour produd is a 100%**re~cka!ling** ofanother purchased EPA·registered prodtd labeled for**a~** the same uses on your label. you do nOl reed to submitlhl!: fonn. You must submil tlla FOlmulalO(S Exemption Slatel1l!!rt1 (EPA FOIm 8570·27). 

# o o t am responding toaDala·Call·ln Notice. and ha;e indudedWith**thi~** tOIm a list of companios senl offers otcompensation 'the Data MaLrix**~Im** shoul:;! be used for this dUrpose).
SEcnON t: METHOO OF OATA SUPPORrIChec.kone method onlyl I am using Iho dlo·ell method ofsupport, andnewlndudedwith this fOIm a fist ofcompanies sent otrelS ofcompens.aUon (the Data**Malti~** folm shoul:;! be lSed ilrthls pUIpOliel. t am using the seledive method of support (or rna-all oplton under the seieclivo methodl, and hiM! lnduck!dwith this form a CQmpleled lisl ofdata requiremenls (the Data Matrix folm musl be used). SECTION tI: GENERAL OFFER TO PAY \Required ifusi"ng Ihedte·ell method orwhen UIlIng the dte-aH optJon under the selediw method to satisfy ooe ormore data requirements] 

# 121 thereby offer and agree to pay compensation. to other persons. wilh regard to the approvat ot lI1is application, to the extent**requ~d** by FIFRA.

SECTION til: CERTlFtCATION t certify that this appUcation fOf registration, this form for roregl5tralion, or thi.<! DlIla-Call·ln reSf)oose is supported byan data swmilled or cited n the application Iorreglstration.iheform for reregistration, orille Dilta-Call·tn response. In addition, ifthe**c~e-aU** option ordle-all option under thc seledive IIl!lthod is indicated h Sedien t, this appicafion is supported byaU data In the Agen::y's files thai (1) amcem Ihe drlJderties oreffeds ofthis produdor an klenV;;zi (..( substantially similar product. or ooe ormore ofthe ngredicnts In this produd; and (2] is a type Ofdata thatwould be required to bc subnitted**under\~~t.~** , requirements In elfed onthe date ofapP"Olilltofthis application ifthe apdlicaiion soughtthe niHal regislratlon 01 a produd ofidentlcatorslmnar**compoEi~on** and uses. 

## i",:, t certify that fcreach cXdusive use study**c~od** in support ofthis registration or rnregislnltion, thai t am the original dal1l,liUl!<lIittll[ or that I haw rblained the written permission OfthB aiginat data subrnitterlo cit8 thBt study. : < .; , t , { , " ; t ' , t ccclify that for each study dtedVl support ofthis registration or reregistration that Is notanexdusive usa study,**oilher«~)J(lathe origln~**  data subm/lter; [b) thave obtained the pelmission ofthe onglnol data submitter to use thesludy in support otitis**~pp~Calion;** (c) all**pt!rlod"P\e:..gib~il)' fo'~.**  t. compensation haw oXP.l"ed forthe study; (d) the study Is In the public**~ternture:** or(e) I hall\! notified In wriling the company Ihat submitted the study;lnd haw: offered (I) to pay compenSiltion tothe extent requircd by seetiooo 3(c)(1)(F) and/or 3{clf2I(B) ofFtFRA; and (ill to commence**ncgJ(.a'.iGn"~** to delelm',ne Ih',,' amourt and t!lllTlS ot compeosatlon. ifall)', tobe paid for the use otthe study. , , ; , , ' t

, 

### , I oectify that in aU Instances where ano/f{!rofcompensatlon Is requroo, aJpies ofal olfers to pay compensation end elOdeJ'lCe oflhllirdi!tit'!!.'Y.l!: { { accordance with sections 3(c]( t)(F) and/or 3(0)(2)(8) ofFIFRA all) :lVililalte and will be submitted to the AQen:;y upon**mque~.** ShDukll hilt to IJ"Od;,ce sud! eVideoc:e to the Agency upOnrequllSl tuooerstilnd thilt the Agency may initiate actfon to der\)'. cancel orsuspood the registration ormy product In coQ'Il.:rrit'with FIFRA. ' , 

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'." t coJ1lfy that1ho statonwnts t havo mado onthts tom and at! atachrnonts to it arntrun, accurab, and comploto. I ackmlwtodgo that any knowingly fatn or mlritoadlng 'IIllI1omom may bo pmJshablo byfino or Imprisonmortlor both undorappltcllbto taw. Signature
EPA FOIm 8570 34 (9-97} E!ectronlC and Papervelllions**ava~able.** Subm,t only Paper vers,on. Typed or Printed Name**~nd** TrUe Ann M. Tillman, Agent

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# 'M' Willowood Oxyfluorfen, LLClWillowood Oxyfluorfen Technical 23 5, NIIffiO and Add/III IIf Applicllnt (Inc/lid" ZIP Cod.} 6. E)Cpedited Reveiw. In accordance with FIFRA Section 31cll3)

Wlllowood Oxyflugrien, llC fbW). mV product is similat or IdentIcal in composi1ign and labeling clo Pyxls Regulatory Consulting, Inc. to: 

## 11603-29 4110136thSI.NW EPA Reg. No. Gig Harbor, WA 98332 

# o Chllck ifthis f$ II mlw .ddtU$ Product Name Galigan Oxyfluorfen Technical 

### Section**~** 

### II 

# 0 Amendment

- Explein belew. 

# U Finol printed**I~bels** in**rep~onse** te Agency lottel dated 

# 0 Ruubmlulon In respense to Agencylettel doted 

# 0 "Me Tee" Applicatien. 

# 0 Netificatien· Explein belew. 

# 0 Othel' Explain below. EXplanation: US" additlenal pagelsl if necessory. IFor seetlen Iend Sectlen 11.1 This application fans under Category R310 (46: New manufacturing use product) because it is an app5cation for registration for a new technical product identical in composition to a currentlyregistered p/oduct. The fee which is due is $4.578.00 but Wiflowood Oxyfluorfen. LLC is requesting a small business fee reduction of 50% to $2,289. The decision timeline is 6 months. 

### Section
- III 1. Mltlrill! thill Product Will Be PeebOld In: Child·Resi'lIlnt P4e\.:eging Unit Pac\.:eg.ing Water Soluble Pec\.:eging 2. Type 01 Containar 

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## U Contoiner**~OnL.lb.1** ,«<" Labal 25 kg

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# I",,' ' Name Title Telephene No.llnclude A,ea Code! Pyxis Regulatory Consulting, Inc. Agent (253)-853-7369: ' , ,

### ~ < Certification 6. Dete AF,,:;,.-jen I cenify thet the stetements I**he~** ml!de en this felm and aU ettochmentll therato ere true, Iccurate end cempletl.**RICei~~,** , , ' lec\.:no

.....ledge thllt eny\.:newlinglly fekle or miole&ding stetament may be pUNlheble by line er impriuolVTlent or (Stamped) beth under eppllcable law. 2. Signetule

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. . PA Form 8610·' !R,v. 3·541 PreVieus edmen. ere ob.olete• WhIte

- EPA Fa. Copy torigln.J1 Velow

_AppIk:.n1 Copv

### Form Approved OMB No. 

### 2070·0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

### 401 M Street, S.W. WASHINGTON, D.C. 20460 

### Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 

### 0.25 hours per response for registration activities and 

### 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate orany other aspect ofthis collection ofinformation, including suggestions for reducing the burden to: Director, OPPE Information Management Division 

### (2137), U.S. Environmental Protection Agency, 

### 401 M street, S.W., Washington, DC 

### 20460. Do not send the form to this address. DATA MATRIX 

### Date Jan. 

### 5, 2010 EPA Reg. No.lFile Symbol 87283· 

# I Page 1 of6 

### Applicant's/Registrant's Name &Address Product Willowood Oxyfluorfen, LLC Willowood Oxyfluorfen Technical 

### 8690 Lookingglass Road Rosebura, OR 

### 97470 Ingredient Oxyfluorfen (CAS No. 42874-03-3) Guideline Reference Number Guideline Study Name MRIO Number Submitter Status Note Product Specific Data Requirements 830.1550 

### Product Identity and Composition Volume 

### 1 Willowood Oxyfluorfen, LLC OWN 830.1600 

### Description of Materials Used to Produce the Volume 

### 1 Willowood Oxyfluorfen, LLC OWN 

### Product 830.1620 

### Description of Production Process Volume 

### 1 Willowood Oxyfluorfen, LLC OWN 830.1650 

### Description of Formulation Process Not Required 1 830.1670 

### Discussion of Formation of Impurities Volume 

### 1 Willowood Oxyfluorfen, LLC OWN 830.1700 

### Preliminarv Analvsis 830.1750 

### Certified Limits Volume 

### 1 Willowood Oxvfluorfen, LLC OWN 830.1800 

### Enforcement Analytical Method Volume 

### 1 Willowood Oxyfluorfen, LLC OWN 830.6302 

### Color 

# · . ,.**~""~** 

### Volume 2 Willowood Oxyfluorfen, LLC OWN 

## · . Physical State " 

# . 

# .. . Volume 2 Willowood Oxyfluorfen, LLC OWN 830.6303 ,. ,. ,.**~** " 830.6304 

### Odor 

# . ,.**~ ~**  

### "" Volume 2 Willowood Oxyfluorfen, LLC OWN 830.6313 

### Stability to Normal and Elevated Temperatures, Volume 2 Willowood Oxytluorfen, LLC OWN Data 

### Metals and**M~'i:all({~'ls ~** **~:** 

### "",,**~** 

### "" " Volume 

### 3 Willowood Oxytluorfen, LLC OWN

### Waive~ ',.,. 

## .. ""**~,.~** 

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# . . Name and Tille Oate 

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# rL)l<<JdL • • 

# . Ann M. Tillman, Consultant Jan. 

### 5,2010

EPA Form 8570-35 (9·97) Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMB No. 2070-0060 UNITED STATES ENVIRDNMENTAL PROTECTIDN AGENCY 401 M Street, S.W. WASHINGTDN, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection ofinformation is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do notsend the form to this address. DATA MATRIX Date Jan. 5, 2010 EPA Re

. No.lFile S mbol 87283- Pa e2.of6 Applicant's/Registrant's Name & Address Product Willowood Oxyfluorfen, LLC 8690 Lookingglass Road Willowood Oxyfluorfen Technical**Roseb~** OR 97470 Ingredient Oxyfluorfen (CAS No. 42874-03-3) Guideline Reference Number Guideline Stu2.Y.,Name MRID Number Submitter Status Note 830.6314 

## I Oxidation/Reduction: Chemical Incompatibility Volume 2 Willowood Oxyfluorfen. LLC OWN 830.6315 

## I Flammability Volume 3 Willowood Oxyfluorfen, LLC OWN Waiver 830.6316 

## I Explodability Volume 3 Willowood Oxyfluorfen, LLC OWN Waiver 4 830.6317 

## I Storage Stability PRN 92_55 830.6319 

## I Miscibility Not**R~!:lired6** 830.6320 

## I Corrosion Characteristics PRN 92-5' 830.6321 

## I Dielectric Breakdown Voltaqe Not Required6 830.7000 

## I pH Volume 2 Willowood Oxytluorfen, LLC OWN 830.7050 

## I UVNisibleAbsorption Volume 2 Willowood Oxyfluorfen, LLC OWN 830.7100 

## I Viscosity Not Required6 830.7200 

## I Melting Point/Melting Range**~** Volume 2 Willowood Oxyfluorfen, LLC OWN



# - 830.7220 

## I Boiling Point/Boiling Rapgr::' ;**~ ~:::**  Not Required 7 830.7300 

## I Density/Relative DensityiS-ulk b"ensity 

# IVolume 2 

# I Willowood Oxyfluorfen. LLC 

## I OWN 

# I830.7370 Dissociation**~onstants** in**~ter** Volume 3 Willowood Ox fluorfen. LLC OWN Waiver"

Signature**~ ~** **~;** Name and Tille Date ;:**~** : ; Ann M. Tillman, Consultant Jan. 5, 2010


# - ,

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# -- -

EPA Fonn 8570-35 (9-97) Electronic and Paperversions available. Submil only Paperversion. Agency Internal Use CopyForm Approved OMS No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460

, I Paperwork Reduction Act Notice: The public reporting burden for this collection ofinformation IS estimated to average 0.25 hours per response for registration

activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date Jan. 5, 2010 EPA Reg. No.lFile Svmbol 87283- 

# I Page3016 Applicant'sfRegistrant's Name & Address Product Willowood Oxyfluorien, LLC Willowood Oxyfluorien Technical 8690 Lookingglass Road Roseburg, OR 97470 InQredient Oxyfluorfen (CAS No. 42874-03-3) Guideline Reference Number Guideline Studv Name MRIO Number Submitter Status Note 830.7520 Particle Size, Fiber Length, and Diameter Not Required6 Distribution 830.7550 Partition Coefficient (n-octanol/water), Shake Volume 3 Willowood Oxyfluorfen, LLC PL Flask Method 830.7560 Partition Coefficient (n-octanol/water), See 830.7550 Generator Column Method 830.7570 Partition Coefficient (n-octanol/water), See 830.7550 Estimation by Liquid Chromatography 830.7840 Water Solubility: Column Elution Method; Volume 3 Willowood Oxyfluorfen, LLC PL Shake Flask Method 830.7860 Water Solubility, Generator Column Method See 830.7840 830.7950 Vapor Pressure 

# ·
.**~ ,,~~**  Volume 3 Willowood**Oxy~uorfen,** LLC PL 

# · . 

# ... .. 

# .**~ ~** **~ ~**  

### ,. 870.1100 Acute Oral Toxicity: Rat**~ ~..,** **,,~~** Cite-All PAY 870.1200 Acute Dermal Toxicity: Rat Cite-All PAY Acute

### Inhalati9n:;.-ro~icity:**R~1 ~;** **~** 

# . "" 870.1300 

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### .. Ann M. Tillman, Consultant Jan. 5,2010

EPA Fonn 8570·35 (9·97) Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use Copy

### Form Approved OMS No. 

### 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

### 401 M Street, S.W. WASHINGTON, D.C. 20460 

### Paperwork Reduction Act Notice: The public reporting burden forthis collection of information is estimated to average 

### 0.25 hours per response for registration activities and 

### 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection 

### of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division 

### (2137), U.S. Environmental Protection Agency, 

### 401 M Street, S.W., Washington, DC 

### 20460. Do notsend the form to this address. DATA MATRIX 

### Date Jan. 

### 5, 2010 EPA Reo. No.lFile Symbol 87283- 

# I Paoe'1016 

### Applicant's/Registrant's Name & 

### Address Product Willowood Oxyfluorfen, LLC Willowood Oxyfluorfen Technical 

### 8690 Lookingglass Road

### Roseb~r~, OR 

### 97470 Inaredient Oxvfluorfen (CAS No. 

### 42874-03-3) Guideline Reference Number Guideline Stud u 

### Name MRID Number Submitter Status Note 870.2400 

### Primarv Eve Irritation: Rabbit Cite-All PAY 870.2500 

### Primarv Dermal Irritation Cite-All PAY 870.2600 

### Dermal Sensitization Cite-All PAY 

### Oxvfluorfen Product Soecific and Generic Data ReQuirements Willowood Oxyfluorfen, LLC will make offers-to-pay to the following companies on the oxyfluorfen data submitters list of Seotember 

### 30, 2009. Cite-All The Scotts Company PAY Ctte-AII 

### Monsanto Company PAY 

### Cite-All Chemisco PAY



# - 

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### Cite-An Aaan Chem MIa. Ltd. PAY



### - 

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### Cite-All Harrell's LLC PAY



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### Ann M. Tillman, Consultant Jan. 

### 5,2010
EPA Form 8570-35 (9-97) ElectroniC and Paperversions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S,W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection ofinformation is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date Jan. 5, 2010 EPA Reo. No.lFile Symbol 87283- 

# I Paoe::; 

### 016**~ ~.**  Applicant'sJRegistrant's Name & Address Product Willowood Oxyfluorfen, LLC Willowood Oxyfluorfen Technical 8690 Lookingglass Road RoseburQ, OR 97470 Inaredient Oxvfluorfen (CAS No. 42874-03-3) Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note Cite-All Makhteshim Agan of North PAY America, Inc. Cite-All Spray DriftTask Force PAY Cite-All Outdoor Residential Exposure PAY Task Force Cite-All Agricultural Reentry Task PAY Force Cite-All Nations Aq II, LLC PAY**~** Cite-All FIFRA Endangered Species PAY Task Force LLC Cite-All Residential Exposure Joint PAY



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# . Ann M. Tillman, Consultant Jan. 5, 2010

EPA Form 8570·35 (9-97) Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMS No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M 

### Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection ofinformation is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this address.

Date Jan. 5,2010 Applicant'slRegistrant's Name & Address Willowood Oxyfluorfen, LLC 8690 Lookingglass Road Roseburo, OR 97470 Inaredient Oxvfluorfen (CAS No. 42874-03-3) GuideGne Reference Number

Signature

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# I Pace(" 016 Product Willowood Oxyfluorfen Technical

Submitter Status Note Generic Endangered Species PAY Task Force Name and Title Date Ann M. Tillman, Consultant Jan. 5, 2010

Agency Internal Uso Copy 

## .

-

### ( 

## ( Endnotes for Data Matrix for Willowood Oxyfluorfen Technical

1 

### 830.1650**~** These data are not required for the registration ofa technical grade active ingredient product. See 830.1620 for production process information.
2 

### 830.6313**~** Willowood Oxyfluorien, LLC does not package Willowood Oxyfluorien Technical in metal containers, nor is Willowood Oxyfluorfen Technical expected to come into contact with metals or metal 

### ions during its storage or use. Therefore, a waiver from the requirement of these data is requested. Willowcod Oxyfluorien Technical was found to be stable at normal and elevated temperatures. 

### 3830.6315

_ Willowood Oxyfluorien, LLC requests a waiver from the requirement of this data requirement since Willowood Oxyfluorien Technical is a solid and is not expected to be flammable. Please refer to the Confidential Statement of Formula for Willowood Oxyfluorien Technical. 4 

### 830.6316**~** Willowood Oxyfluorien, LLC requests a waiver from this data requirement because oxyfluorien does not have the chemical bonds or functional groups associated with explosive chemicals. Please refer to the Confidential Statement ofFormula for Willowood Oxyfluorien Technical. 

### 5830.6317, 830.6320

- Per PR Notice 92-5, storage stability and corrosion characteristics data are not required to be submitted unless specificaJly requested by the Agency. Willowood Oxyfluorien, LLC agrees to conduct this study if required and requests that the study be made a condition of registration. s 

### 830.6319, 830.6321, 830.7100, 830.7520

_ WiJlowood Oxyfluorien Technical is a solid and not an emulsifiable concentrate and is not to be diluted with petroleum solvents. Therefore, miscibility data are not required for this technical. Willowood Oxyfluorien Technical is not to be used around electrical equipment and data for dielectric breakdown constant are not required. WilJowood Oxyfluorien Technical is a solid and not a liquid, therefore, viscosity data are not required for this product. Willowood Oxyfluorien, LLC is seeking a waiver for particle size, fiber length and diameter distribution because Willowood Oxyfluorien Technical is not water insoluble nor is it a fibrous material. 7 

### 830.7220

_ Willowood Oxyfluorien Technical is a solid and boiling point data are not required for solids. Data for melting point are required for solids. See Guideline 830.7200.**~** e e C e e**~** < c 8 

### 830.7370

_ Willowood OxyfJuorien, LLC is seeking a waiver for this data requirement for V'£iJlp:«,.opd Oxyfluorien Technical because the product does not have any fUnctional groups thatwould dissociate.**"e~,,~<** c c c. 

### , 

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### ITRMD)

1 ITRMO receives paper submission wI a-label on CD

ijSave copy ofe· label from ELL to My Documents

,U Send annotated e-label to registrant via email**lollo.~nd** "HowTo Pronl"l :J. Tracking record added 

### to OPPIN

I Review label (01 aCCllptllblO••kJp la .tap 201

11 File print of annotated e-Jabel and email injackal alTRMD adds a-label to ELL

in-process**~** Add comments to e-Iabel (GaV1l; add"wi1l1 commonls" 10 lilofWl'lll review**I~** Add annotated elabel 

### to ELL out-process 4 lTRMD sends paper submission 

### to AD/BPPDIRO t> Connect ELL record with OPPIN S#

\I Print annotated elabel lu,a "Print with Flianamo'l**I~** Close submission in OPPIN



## Resubmission (via ema!! to staffer or PM)

14 Receive email submission 

### wIelabel attached 1!> Add tracking record to OPPIN It,; Add e-Iabel to ELL

in-process

lU Save copy of elabels (old & new) from ELL to My Documents W Compare old and new labels with Acrobat**~11** Print e-Iabel, 

# " Mail stamped stamp, write cover label & cover letter letter to registrant !u.a"Prlnl withF,lonamll")

process - big picture 1- create OPPIN tracking 2- put label in ELL; link to S# 3- save ELL label to MyDocuments 4- compare 

### I comment 5- outprocess review

:a File stamped label & cover letter in jacket

out-process t I Connect ELL record with OPPIN S#

(if revisions needed repeat steps 8-19)**~~** Add cover letterto ELL !marldala!)l**~** aCCilptad with CIlmmontsl 14 Close submission in OPPIN

techniques to know

- filename for e-Iabels

- "print with filename"

- compare 

### I comment

- printing with comments

### ( ( 

# Certification with Respect to Label Integrity version: 9/11/02



### I certify that the information (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 ofthese documents included with this submission.



### # file name 12,2010

# 10)~~11:~~~~~X;~~~; 00105.Willowood 

# Ie Technical label v1.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 Ann M. Tillman Consultant, Willowood Oxyfluorfen, 

### LLC Jan. 12,2010 Date , 

### , 

## " 

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### ,

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### ,
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### ,UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460


### January 

### IS, 2010

PYXIS REGULATORY CONSULTING, INC. WILLOWOOD OXYFLUORFEN, LLC 4110 1136TH STREET, NW GIGHARBOR, WA 98332-
ReportofAnalysis for Compliancewith PRNotice 86-5 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Thankyou for your 

### submittal of 12-JAN-lO. Our 

### staffhas completed a preliminary analysis ofthe material. The results are provided as follows: Your submittal was found to be in full compliance with the standards for submission of 

### data contained in PRNotice 86-5. A copy ofyour bibliographyis enclosed, annotated with MasterRecordID's (MRIDs) assignedto each document submitted. Please use these numbers in all future references to these documents. Thankyou for your cooperation. Ifyou have any questions concerningthis data submission, please raise them with the cognizant Product Manager, to whom the datahave been released.

# PRIA 2 - 21 Day Content Screen Review Worksheet (EPA/OPP Use Only) 3/23/09 21 Day Screen Start Date: 

# I
- 1'1. -/0 / Experts In-Processing Signature: 

### fYI F HAM,ri67otJ Date 

### 1-**II.{~**

### 10 Fee Paid: Yes_v 

### Division management contacted on issues No Yes Date
EPAReg. Number: 

# 61'2.**'i(~** 

# - EPAReceipt Date:

# l-I~-IO

1

2



### 3

4



## 5

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

### complete 

### including package type
Confidential Statement ofFormula all boxes completed, form signed, and 

### a) All inerts (linkto http://www.epa.gov/opprdOOI/inerts/), 

### including fragrances, approved for the proposed uses (see Footnote A) Certification with Respect to Citation 

### ofData (EPA Form 8570-34) (Link to 

### form) completed and signed (N/A if 100%repack) )( 

### Certificate and data matrix consistent 

### Ifapplicant is relying on data that are compensable, is the offer to pay statement included. (see Footnote B)
is there aletter ofAuthorization for exclusive use completed and 

### sigJ1ed CN/A 

### ifsource is umegistered or 

### aplllicant yes no

DataMatrix (EPA Form 8570-35) (Link to fOlID) both internal and external 

# X 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 

### ofLabel (link to http://www.epa.gov/oppfeadl/labeling/IrmD (Electronic labels on CD are encouraged and guidance is available)( linkto 

# X http://www.epa.gov/pesticides/regulating/registering/submissions/index.htm#labels

I

### (



### 7 Is the data package consistentwith PRNotice 86-5 (link to 

### PRN 86-5) 

# A
Notice ofFiling (linkto 8 

### httl1://www.el1a.gov/l1esticides/regulating/toierance 12etitions.htm) included 

# \- withpetitions (linkto http://www.epa.gov/pesticides/reouIatingltolerances.htm) 

### 9 If

### applicablefor conventional applications, reduced riskrationale (link to 

# ?( http://www.epa.gov/opprdOOl/workpJan/reducedrisk.htmI) Required Data (linkto httl1:i /www.el1a.govil1esticides/reguIating/data 

### reguirements.htm) and/or 

### data waivers. See Footnote C.



### a) List study (or studies) not includedwith application



## 10

2

### (



### Comments: 

# IAJ/**\u..c\t.e~** U-<'(R. 

## iD q::r-q 50_T) 

## \"'{A\)e. ""



# *N/A
- 

### Not Applicable

Footnotes A. 

### Duringthe 21 day initial content review, all CSFs will bereviewed to determine 

### whether all inerts listed, including fragrances, are approved for the proposed uses. Ifan unapproved inert is identified, the applicantmust either 1) resolvethe inert issue 

### by, for example, removingthe inert, substituting

### it with an approved inert, submitting documentationthat EPAapproved the inert for the proposed pesticidal uses, correcting mistakes on the CSF, etc. or2) provide the datato support OPP approval ofthe inert or 3) withdrawthe application. Removing or substituting an inert ingredient will require a new 

### CSF and may require submission ofdata. All infonnation, forms. data and documentationresolving-the inert issue musthave been received bythe Agency orthe application withdrawn withinthe 21 day period. otherwise, the Agency will reject the application as described below. To successfully complete this aspect ofthe 21 day initial content screen, applicants are strongly encouraged to verify that all inert ingredients have been approved for the application's uses even ifa 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 approvalpriorto submitting an application to register a pesticideproduct containingthat inertingredient. Some inert ingredients are no longer approved for food uses or certain types ofuses. The name and/or CAS number on a CSF must match the name and CAS number onthis web site. Simple typographical errors inthe name or CAS number have resulted inprocessing delays. Ifan inertis not listed on the inert ingredient web site and the applicant believes thatthe inerthas been approved, the applicant should contactthe InertIngredientAssessment Branch (IIAB) at inertsbranch@epa.gov and resolvethe issue. Gopies ofthe correspondence with lIAB resolvingthe issue should accompany the application. All newinerts except PIP inerts are reviewed by IIAB. The lIAB should also be contacted for any questions on what supporting dataneeds to be submitted for and the Agency's inert reviewprocess. Questions on PIP inerts should be directed to the Chiefof Microbial Pesticides Branch [Linkto http://www.epa.gov/oppbppdl/biopesticides/contactsbppd.htm]. When a brand, trade, orproprietary name ofan inert ingredientis listed on a CSF, additional information such as an alternate name ofthe inert, CAS number or other infonnation [link to http://WVvw.epa.gov/opprdOOl/inelts/tips.pdfJ must also be included to enable the Agencyto detennine ifit has been approved. Each component ofan inert mixture (including a fragrance) mustbe identified. In some cases, the suppiier ofthe mixture or fragrance may need to provide this informationto the Agency. Prior to the Agency's receipt ofan application, applicants must arrange with a proprietary mixture or fragrance supplierto provide the componentinformationto theAgency or promptly upon EPA'srequest. Ifthe inert ingredients in a proprietary blend (including :fragrances) cannot orare not identified orprovided within the**21~day** 

### contentreviewperiod, the Agencywill rejectthe application. Duringthe 21 day contentreview, applicants should submit information to the individual identified by the Agency when the applicant is informed ofan unapproved inert. Unapproved Inerts Identified on CSFs All applications except conventional newproducts and PIPs Once an unapproved inert is identified ona CSF, the Agency will contactthe applicantwiththe following options: 1. Correct the application by, for instance, correctingthe inert's identity or CAS number, providing documentationthatthe inerthas been approved, or removingthe unapproved inert from the CSF or replacing itwith one that is approved for the application's uses; or 2. Submitthe infonnation and data needed for the Agency to approve the unapproved inert Ifthis option is selected and implemented, the Agency may request an extensioninthe PRlA decision reviewtirnefrarne to acconunodate the inert review/approval process; 

### 4i 

### , (


### 3. Withdrawthe application (the Agencyretains 25% ofthe full fee for the fee category estimated); or Ifnone ofthese options is selected and implementedbythe applicant within the 21 day content reviewperiod, the Agency 

### will rejectthe application and retain 25% ofthe full fee ofthe category identified.**C~nventional** 

### New ProductApplications When the RegistrationDivision identifies an unapproved inert on a CSF with an application for a newproduct that the applicant has not identified as requiring an inert approval (R311, R3l2 orR313), itwill contact the applicantwiththe following options: 1. Correctthe application by, for instance, correcting the inert's identityor CAS number, providing documentation that the inert has been approved, or removingthe unapproved inert from the CSF orreplacing it with one that is approved for the application's uses; or 2. Submitthe infonnation and dataneeded for the Agencyto approve the unapproved inert, including any required petition to establishor amend a toleranceor exemption from a tolerance. (This option may change the PRIA category for the application, which couldrequire a longer decision review time and a larger fee. Ifadditional fees are due, theymust be received by the Agency within the 21 day contentreviewperiod.) 3. Withdrawthe application (the Agency retains 25% ofthe full fee for the fee category estimated); or
Ifnone ofthe above options is selected and implemented duringthe 21-day content-review period,theAgency will rejectthe application and retain 25% of the appropriate fee for the newproduct-inert approval category. PIP Applications "When the Biopesticide and Pollution Prevention Division identifies an unapproved inerton a PIP CSF and a requestto approvethe inert does not accompanythe application, itwill contactthe applicant with the following options: I. Correctthe application by, for instance, correcting the spelling or name ofthe inertto that in 40 CFR 174, or providing documentationthatthe inert has been approved; or 2. Submitthe infonnation and dataneeded for the Agency to approvethe unapproved inert. Ifan inert ingredienttolerance exemption petition is required, the petition must be received by the Agency and the B903 fee paid within the21 dayperiod. Ifthis option is selected and implemented, the Agency will discuss harmonizingthe timeframe for both actions. 5I



### 3. Withdrawthe application (the Agency retains 25% ofthe full fee for the fee category estimated); or lfnone ofthe above options is selected and implemented during the 21 day contentreviewperiod, the Agency will rejectthe applicationand retain 25% of the fee.

B. A policy on documentation ofoffers to payis still being developed, however, for a me-too or fast track (similar/identical) newproduct, R300 orA530, an application without the necessary authorizations ofoffers to pay will beplaced into eitherR301 or 

### AS31. The Agency recommends that authorizations ofoffers to pay be submitted with other

### PRIA applicaHons to avoid delays inthe Agency's decision. C. Biopesticide applicants are advised to contact the Agency and discuss study waivers priorto sUbmitting their applicationto the Agency. Documentation ofsuch discussions should be submitted with the studywaiver.



### 6

# ( ( UNITeD STATES ENVIRONMENTAL PROTECTluN AGENCY WASHINGTON, D.C. 20460


### January 13, 2010

OPP DecisionNwnber: D-426039 EPA File Symbol or RegistrationNwnber: 87283-R ProductName: WILLOWWOOD OXYFLUORFEN TECHNICAL EPA Receipt Date: 12-Jan-2010 EPA CompanyNwnber: 87283 CompanyName: WILLOWOOD OXYFLUORFEN, LLC JANELLEKAY PYXlS REGULATORY CONSULTING, INC. WlLLOWOOD OXYFLUORFEN, LLC 4110 I 136TH STREET, NW GIG HARBOR, WA 98332- OffiCE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### SUBJECT: Receipt ofApplication and 50% Small Business Waiver Request Dear Registrant: The Office ofPesticide Programs has received your application, 50% small business waiver request, and cerification ofpayment. Ifyou submitted datawith this application, the results ofthe PRN-86-5 screen will be communicated separately. Duringthe administrative screen, the Office ofPesticide Programs has detennined thatthis Action is subjectto a Pesticide Registration Service Fee as defined in the Pesticide Registration ImprovementAct. The Actionhas been identified as Action Code: R310 NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTETOXICITY;PUBLlC HEALTH PESTEFFICACy); Your request for waiver has been forvvarded for review. You will be notified in writing when a detenninationis made regarding your request. Ifyour waiverrequest is approved, the decision reviewtime period will start onthe date ofapproval. Ifyour waiver request is denied, youwill receive an invoice for the outstanding balance. Ifyou have any questions, please contactthe Pesticide Registration Service Fee Ombudsman at (703) 305-6249. Sincerely,

# ~D~ Front End Processing Staff Infonnation Technology & 

### Resources Management Division

# i IFee for Servicel 

# {865465C-

,------------------ 

## This package includes the following

@ 

# New Registration oAmendment
Ii'l 

# Stud,s? 0 

# Fee Waiver? ovolpay 

# % Reduction: __ '---------------

--------------------------------------- ----------------------- ----- 

## for Division 

# OAD OBPPD @RD Risk Mgr. Receipt No. 

# s-I 865465 EPA File Symbol/Reg. No. 1 

# 87283-R Pin-Punch Date: 1 

# 1/12/2010 _-' This item is NOT subject to FFS action. -- ------- -- j

--------- -------- ------------- ----------------------- ------------------- 

# Requested: 

# I

# ~31D Granted: 

# I IZ3lo Amount Due: 

# $ 

# 4,51C6 Parent/Child Decisions:

D 

# Inert Cleared for Intended Use 0 

# Uncleared Inert in Product Reviewer:

# ~~ Remarks: 

# Date: 

# 'U2Iro
/ Ialliable; 

### r.'Yes 

# r No

2-Jan-2010 Tracking



# I

I View/Edit

# FEE 

# FOR SERVICE

## ( Mike Kellogg From: Sent: 

### To: 

### paygovadmin@maiLdoc.twai.gov Monday, January 11, 2010 1:22 PM Mike Kellogg Subject: 

### Pay.Gov Payment Confirmation
THIS IS AN AUTOMATED MESSAGE. PLEASE DO NOT REPLY. Your transaction has been successfully completed. Transaction Summary Application Name: PRIA Service Fees Pay.gov Tracking ID: 2507TF3J Agency Tracking 10: 74896491636 Account Holder Name: Brian Heinze Transaction Type: Sale Transaction Amount: $2)289.80 Billing Address: 8698 Lookingglass Road City: Roseburg State/Province: DR Zip/Postal Code: 97471 Country: USA Card Type: Master Card Card Number: ************6885 Transaction Date: Jan 11) 2810 4:22:08 PM Decision Number: Registration Number: 87283-xx Company Name: Willowood Oxyfluorfen) LL Company Number: 87283 Action Code: R310

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