# REGISTRATION 35935-83

### "._-_.-- 

# ISB'S Front-end PRIA Completeness Screen Draft 3; 10/25107



### EP/\ Receipt Date: 

# 1/1'1/11? EPA Reg. Number:

## JSY""

## 6- A:j 

## _. Checl(LisiItem

. . ""'-' 

## Yes No

. ,,- 

# . , ,-" 

### 1 

### Has the PRIA Fee been Paid; is a copyofthe check or 

# ./ Pay.gov receipt included in the Submission Package? 

## -. Is an Application Form (EPA Fonn 8570-1) Included 

### in the 

## ./ 2 

### SubmissIon Package, is it completely filled out and signed including package type? 

# _. Is a Confidential StatementofFormula (EPA Fonn 8570- 

# ./ 3 29) Included inthe SubmissionPackage, is it completely filled out and signed (boxes 1-21)?
4 

### Is a Formulator's Exemption Statement(EPA Form 8570- ,/ 27) Included in the Submission Package? ,,-- 

### 5 Is**~I** 

### Certification**wi~** 

### Respectto Citation ofData (EPA 

### F.'orm 8570-34) Included in the Submission Package? V-



## - 

# lis a Data Matrix (EPA Fonn 8570-35) Included in the

() 

### V

### Submission Package? 

# t?**I~** 

### a Label Included in the Submission Package? </" 

# I H 

## ,--- Arc Data Included in the Submission Package? V" 

# l_''.. rs the Submission an Amendment? 

### v 

# I I 

### N/A

I

# NEWAPPLICATIONS DATE: ..!,L1&='.!itL!..!1fL.t) __ _ 

# FILE NUMBER:**~00'~S'::£.~6~-_- =/Cf~**  __ _ 

# .FEP (OPPINENTRY) ,e'n> 

# ifP' !/p 

# (Initial & 

# date) 

# FILEROOl\1: 

# lk. J/a9/;()

. (InftiaI & 

# date) 

# SIG: (Initial & date) 

# FILE ROOM: _____ _ (Initial & 

# date) 

# ;( ASSIGN TO P·M**~.j'** 

# (NO DATA)

__ JACKET TO 

# SHELF (DATA)

# Material to be added to an e-Jacket Reg. No. 

# 3S 

# 7 3

# s-- !(3**~Iacement** 

# within the e-Jacket: Default: chronological top Other: (PDF page number, i.e., "before page 45'')**2.I~his** 

# material:**~** 

# Newly stamped accepted label "-

. Notification "-l 

# New CSF Final Printed Label Other: ____________ _ 

# 3.Attach this notice on top ofthe material. 

# It must be clipped all together, NOT STAPLED. Then give the material with this coversheet to staff in the Information Services Center (Room 230).
Reviewer's Name:

# Ph t'

# I**E~(2!~** , 

# Phone: 

# JOs-, 0

# bb3 Division:

# ~p Date: / / / 

# j'i / (}7)J(J

### Response to registration request for Nufarm Pic10ram Technical, EPA Reg. No. 35935-83 with attachment. Philip Errico to: George Meindl Cc: Jim Tompkins

.... 

# _-_
...

### _ ..... -----------'-.',,--

### _.- ......•... ...................................._._._ .. _.. Mr. Meindl, 11/17/201012:47 PM

Please see the attached response to registration requestfor Nufarm Picloram Technical, EPA Reg. No. 35935-83. Best Regards,

EPA REG NO 35935·83, NOV 9, 2010, NUFARM PICLORAM TECH.pdf Philip (Phil) V. Errico, Senior Chemist U. S. Environmental Protection Agency Office of PesHcide Programs Registration Division/Herbicide Branch (7S0SC) Phone:**703~30S~6663** Fax: 703-308-1825 Email: Errico.Philip@epa.gov**.;:,,<!-\"'£'OS7".<I~** U.S. ENVIRONME"'TAL PROTECTIO;"l AGENCY EPA Reg. Number: Date ofIssuance:

### ~. 

# ft

..... Office ofPesticide Programs

# \~o'l Registration Division (750SP) 

## 35935-83 NOV 091010 

# '., 1200 Pennsylvania Ave.• N.W.

4{**"RO"'~** Washington. D.C. 20460 

### NOTICE OF PESTICIDE, Term ofIssuance: 

## -.X.. Registration

_ Reregistration Unconditional (under FIFRA. as amended) Name ofPesticide Product: 

### NUF ARM PICLORAM TECHNICAL "·ame and Address ofRegistnnt (include ZIP Code): 

# N tv

## ~o.ww-....**~~~** . 

## h d-OU

# ~ 1':>0**~** 

### . "". 

## f:l"",<

## Q.:J.':.~ 

# .1L "OS";J.')
Note: Changesin labelingdiffering in substmicefrom thatacceptedin connectionwiththis registrationmustbe submittedtoand acceptedbythe RegistrationDivisionpriortousc ofthe'label in eommeree. In any correspondence onthis productalwaysrererto the above EPAregistration number

.

. On the basis ofinfonnation furnished bytile registrant, the above named pesticide is hereby registered/reregistered underthe Federallnseetieide, Fungicide and Rodenticide Act. Registration is in no way to be construed as an endorsementor recommendation ofthis productby the Agency. In order to protect health and the environment. the Administrator, on his motion, may at any time suspend oreaneellhe registration ofa pesticide in accordance with the Act. The acceptance ofany name in connection with the registration ofaproduct under this Act is not to be construed as givingthe registrant aright to exclusive use ofthe name orto its use ifit has been covered by others. 

### This product is unconditionally registered in accordance with FIFRA section 3(c)(5)provided thatyou: Submit 

### andlor cite all data required for registration ofyourproduct under FIFRA sec 3( c)(5) whenthe Agency requires all registrants ofsimilar productsto submit suchdata; and submit acceptable responses required for registration review ofyourproductunder FIFRA section 3(g). The requested draft label as submitted is not acceptable. It will be acceptable ifthe following changes to the label are made before shipping anyproduct:

a. Change the product registrationnumber to "EPAReg. No. 35935-83". b. Add the establishment number. c. Add the batch numberto all products in disposable containers before shipment. d. On page 2, under >!DlRECTIONS FORUSE'r, change the fourth sentence starting with "Uses for whichthe USEPA has accepted, etc." to "This productmaybeused to formulate products for specific use(s) not listed on the manufacturing use product label if: I. The formulator, user group or grower has complied with U.S. EPA submissionrequirements to support such use(s), and 2. End-use products have EPA an approved stewardship program inplace. e. On page 3, under "WARRANTYDISCLAIMER", add to the second sentence "TO THE EXTENT CONSISTENT WITH APPLICABLE LAW" before"

...ASSUMED BY BUYER ORUSER."
Pagelof2

### A stamped accepted label with comments is enclosed for your files. Submit one copy ofthe revised final printed label for the record before the product is released for shipment. Ifthese conditions are not complied with, the registrationwill be subject to cancellation in accordance with FIFRA section 6(e). Your release for shipment ofthe product constitutes acceptance ofthese conditions. Please contact Phil Errico at 703-305-6663/elTico.ghili1201ega.com

.

# Sig"'t"{'ofAPt~ Date: 

## NOV 091010

# JameS~Om~Oduct Manager(25) Herbi .Ide**B~anch,** 

### Registration Division (7505P) EPAForm:8570 6 

### - ; 

# \. Encloseure': Label stamped "Accepted With Comments".



### Page2of2

## NUFARM PICLORAM TECHNICAL FOR MANUFACTURING USE ONLY
ACT1VE INGREDIENT: Picloram: 4-amino-3, 5, 6-trichloropyridine-2-carboxylic acid,

... , , . , , , ........ , 93% OTHER INGREDIENTS: , , , , , , , , , , , ' , , , , , , , , , ' , , , , , , , , , ' , , , , , , , , , ' , , , , , 7% TOTAL:

.............. , , ....... , , , . . . . . . . . . . . . . . . . . . . . . lOaoh
KEEP OUT OF REACH OF CHILDREN WARNING S1 usted no entiende la etiqueta, busque a alguien para que se la explique a usted en detalle. (Ifyou do not understand the label, find someone to explain it to you in detail.)
FIRST AID IF IN EYES Hold eye open and rinse slowly and gently with water for 15-20 minutes. Remove contact lenses, 

### if present, after the first 5 minutes, then continue rinsing 

### eye. Call a polson control center or doctor for treatment advice. Have the product container or label with you when calling a poison control center or doctor, or going for treatment, For Chemical Spill, Leak, Fire or Exposure, Call CHEMTREC 800-424-9300 For Medical Emergencies Only, Call 877-325-1840
PRECALmONARY STATEMENTS HAZARDS TO HUMANS & DOMESTIC ANIMALS WARNING
- AVISO Causes substantial but temporary eye injury. Do not get in eyes or on clothing. Wear protective eyewear (goggles or face shield). Wash thoroughly with soap and water after handling. Remove contaminated clothing and wash clothing before reuse.

EPA Reg. No. 35935-xx NET CONTENTS: 

### ACCEPTED with 

### COMMENTS In

### EPA Letter 

### Dated 

## NOV 09 1010 UndertheFederall:aeeetieide.**Fuadieide,ud.~Aet**

.. amended.. Cor the peedcide**re~te~wulerEPAIlK.**No. 

## 3S-PS-P**~** Manu::tured For:

Nufarm Limited RTP, NC 27709 EPA Est. No.ENVIRONMENTAL HAZARDS This pesticide is toxic to some plants at very low concentrations. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public waters unless in accordance 

### with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit 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. For guidance contact your State Water Board or Regional Office afthe ERA. DIRECT10NS 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 formulated into manufacturing-use herbicide products or end-use herbicide products for the following uses: Rangeland and permanent grass pastures, barley, oats and wheat, fallow cropland, Conservation Reserve Program (CRP), forests and non-cropland. Because of their properties and intended uses, herbicidal formulations containing this product will require precautionary labeling differing from that given. Formulators should develop their own use and precautionary labeling, based on the properties and intended uses of their finished formulations and are responsible for obtaining EPA registration for these products. Uses for which the USEPA has accepted the required data and/or citations of data that the formulator has submitted in support of registration. For experimental use purposes that are in compliance with USEPA reqUirements. Consult Nufarm, Inc. for formulation and other information. HANDllNG PRECAUTIONS Do not contaminate water. Do not allow this product to contaminate water used for irrigation, drinking or other domestic purposes. Do not clean containers near water used for these purposes. Do not contaminate atmosphere. When formulating dry products, do not allow dust particles from this product to contaminate the atmosphere. Small amounts may injure certain broadleaf plants. STORAGE AND DISPOSAL Do not contaminate water, food, or feed by storage and disposal. PESTICIDE STORAGE: Store in a cool, dry, well-ventilated area. PESTICIDE DISPOSAL: Pesticlde wastes are acutely hazardous. Improper disposal ofexcess pesticide, spray mixture, or rinsate is a violation of Federal law. Ifthese wastes cannot be disposed of by use according to label instructions, contact your state pesticide or environmental control agenc.y, or the hazardous waste representative at the nearest ERA regional office for guidance. CONTAINER DISPOSAL: Nonrefillable container. 

### Do not reuse or refI11 this container. Compl,etelV**emp~** inner liner by shaking and tapping sides and bottom to loosen clinging particles. Then**emp~** re:.;idue into formulation equipment. Dispose of inner liner in a secure landfill or by inclneration if allowed bystate and local authorities. Offer for recycling, if available. Offer for reconditioning, ifappropriate: Ifdrum cannot be recycled or reconditioned, puncture and dispose of in a secure sanitary landfill, cr 0'1 other

2procedures approved 

### by state and local authorities.
WARRANTY DISCLAIMER The directions for use of this product must be followed carefully TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, (1)THE GOODS DELIVERED TO YOU ARE FURNISHED"AS IS"BY MANUFACTURER OR SELLER AND (2) MANUFACTURERAND SELLER MAKE NO WARRANTIES, GUARANTEES, OR REPRESENTATIONS OF ANY KIND TO BUYER OR USER, EITHER EXPRESS OR IMPLIED, OR BY USAGE OF TRADE, STATUTORY OR OTHERWISE,WITH REGARD TO THE PRODUCT SOLD, INCLUDING, BUT NOT LIMITED TO MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, USE, OR ELIGIBILITY OFTHE PRODUCT FOR ANY PARTICULARTRADE USAGE. UNINTENDED CONSEQUENCES, INCLUDING BUT NOT LIMITED TO INEFFECTIVENESS, MAY RESULT BECAUSE OF SUCH FACTORS AS THE PRESENCE OR ABSENCE OF OTHER MATERIALS USED IN COMBINATION WITH THE GOODS, OR THE MANNER OF USE OR APPLICATION, INCLUDING WEATHER, ALL OF WHICH ARE BEYOND THE CONTROL OF MANUFACTURER OR SELLER AND ASSUMED BY BUYER OR USER. THISWRITING CONTAINS ALL OF THE REPRESENTATIONS AND AGREEMENTS BETWEEN BUYER, MANUFACTURER AND SELLER, AND NO PERSON OR AGENT OF MANUFACTURER OR SELLER HAS ANY AUTHORITY TO MAKE ANY REPRESENTATION OR WARRANTY OR AGREEMENT RELATING IN ANY WAY TO THESE GOODS. LIMITATION OF LIABILITY TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, IN NO EVENT SHALL MANUFACTURER OR SELLER BE LIABLE FOR SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, OR FOR DAMAGES IN THEIR NATURE OF PENALTIES RELATING TO THE GOODS SOLD, INCLUDING USE, APPLICATION, HANDLING, AND DISPOSAL. TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, MANUFACTURER OR SELLER SHALL NOT BE LIABLE TO BUYER OR USER BY WAY OF INDEMNIFICATION TO BUYER OR TO CUSTOMERS OF BUYER, IF ANY, OR FOR ANY DAMAGES OR SUMS OF MONEY, CLAIMS OR DEMANDS WHATSOEVER, RESULTING FROM OR BY REASON OF, OR RISING OUT OF THE MISUSE, OR FAILURE TO FOLLOW LABEL WARNINGS OR INSTRUCTIONS FOR USE, OF THE GOODS SOLD BY MANUFACTURER OR SELLER TO BUYER. ALL SUCH RISKS SHALL BE ASSUMED BY THE BUYER, USER, OR ITS CUSTOMERS.TO THE EXTENT CONSISTENTWITH APPLICABLE LAW, BUYER'S OR USER'S EXCLUSIVE REMEDY, AND MANUFACTURER'S OR SELLER'S TOTAL LIABILITY SHALL BE FOR DAMAGES NOT EXCEEDING THE COST OF THE PRODUCT. Ifyou do not agree with or do not accept any of directions for use, the warranty disclaimers, or limitations on liability, do not use the product, and return it unopened to the Seller, and the purchase price will be refunded. (NEW)

3

### NUFARM PICLORAM TECHNICAL FOR MANUFACTURING USE ONLY
ACITVE INGREDIENT: Picloram: 4-amino-3, 5, 6-trichloropyridine-2-carboxylic acid

................... 93% OTHER INGREDIENTS:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7% TOTAL:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100%
KEEP OUT OF REACH OF CHILDREN WARNING S1 usted no entiende la etiqueta, busque a alguien para que se la explique a usted en detalle. (Ifyou do not understand the label, find someone to explain it to you in detail.)
FIRST AID IF IN EYES Hold eye open and rinse slowly and gently with water for 15-20 minutes. 

### Remove contact lenses, if

### present, after the first 5 minutes, 

### then continue rinsing 

### eye. Cal! a Doison control center or doctor for treatment advice. Have the product container or label with you when calling a poison control center or doctor, or going for treatment. For Chemical Spill, Leak, Fire or Exposure, Cal! CHEMTREC 800-424-9300 For Medical Emergencies Only, Call877-325-1840
PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS & DOMESTIC ANIMALS WARNING
- AVISO Causes substantial but temporary eye injury. Do not get in eyes or on clothing. Wear protective eyewear (goggles or face shield). Wash thoroughly with soap and water after handling. Remove contaminated clothing and wash clothing before reuse.

EPA Reg. No. 35935-xx NET CONTENTS:
Manufactured For: Nufarm Limited RTP, NC 27709 EPA Est. No.

1ENVIRONMENTAL HAZARDS This pesticide is toxic to some plants at very low concentrations. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public waters unless in accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit 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. For guidance contact your State Water Board or Regional Office ofthe ERA. DIREGnONS 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 formulated into**manufacturing~use** herbicide products or**end~use** herbicide products for the following uses: Rangeland and permanent,..9.@ss.**~K}::;tllx-es,_J~arley,** oats and**1jyb~9t,** fallow cropland, Conservation Reserve Program (CRP), forests and**non~cropland,** Because-of their pro-ife?fleS--and--jntended uses, herbicidal formulations containing this product will require precautionary labeling differing from that given. Formulators should develop their own use and precautionary labeling, based on the properties and intended uses of their finished formulations and are responsible for obtaining EPA registration for these products. Uses for which the USEPA has accepted the required data and/or citations of data that the formulator has

## ~~~i~;_in0~~K~~_rso~~~~~\~~~ "-___

## (_~p,**t'1;;\'?N~" nh!)Jj~~'L"**  f

## ~YAt''''' "" 

# flt.·ct , For experimental use purposes that are in compliance with USEPA requirements. Consult Nufarm, Inc. for formulation and other information.

### ;&f/~_u HANDUNG PRECAUTIONS Do not contaminate water. Do not allow this product to contaminate water used for irrigation, drinking or other domestic purposes. Do not clean containers near water used for these purposes. Do not contaminate atmosphere. When formulating dry products, do not allow dust particles from this product to contaminate the atmosphere. Small amounts may injure certain broadleaf plants. STORAGE AND DISPOSAL Do not contaminate water, food, or feed by storage and disposal. PEsnODE STORAGE: Store in a cool, dry, well-ventilated area. PEsnODE DISPOSAL: Pesticide wastes are acutely hazardous. Improper disposal of excess pesticide, spray mixture, or rinsate is a violation of Federal law. Ifthese 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 ERA regional office for guidance. CONTAINER DISPOSAL: Nonrefillable container. Do not reuse or refill this container. Completely empty inner liner by shaking and tapping sides and bottom to loosen clinging particles. Then emptY residue into formulation equipment. Dispose of inner liner in a secure landfill or by incineration ifallowed by stat.: and local authorities. Offer for recycling, ifavailable. Offer for reconditioning, ifappropriale. Ifdrum cannot be recycled or reconditioned, puncture and dispose of in a secure sanitary landfill, ('r 

### by other

2procedures approved 

### by state and local authorities.
WARRANTY DISCLAIMER The directions for use of this product must be followed carefully TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, (1)THE GOODS DELIVERED TO YOU ARE FURNISHED"AS IS"BY MANUFACTURER OR SELLER AND (2) MANUFACTURER AND SELLER MAKE NO WARRANTIES, GUARANTEES, OR REPRESENTATIONS OF ANY KIND TO BUYER OR USER, EITHER EXPRESS OR IMPLIED, OR BY USAGE OF TRADE, STATUTORY OR OTHERWISE,WITH REGARD TO THE PRODUCT SOLD, INCLUDING, BUT NOT LIMITED TO MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, USE, OR ELIGIBILITY OF THE PRODUCT FOR ANY PARTICULARTRADE USAGE, UNINTENDED CONSEQUENCES, INCLUDING BUT NOT LIMITED TO INEFFECTIVENESS, MAY RESULT BECAUSE OF SUCH FACTORS AS THE PRESENCE OR ABSENCE OF OTHER MATERIALS USED IN COMBINATION WITH THE GOODS, OR THE MANNER OF USE OR APPLICATION, INCLUDING WEATHER, ALL OF WHICH ARE BEYOND THE CONTROL OF MANUFACTURER OR SELLER ANDfASSUMED BY BUYER OR USER. THISWRITING CONTAINS ALL OF THE REPRESENTATIONS AND1AGREEMENTS BETWEEN BUYER, MANUFACTURER AND SELLER, AND NO PERSON OR AGENT OF MANUFACTURER OR SELLER HAS ANY AUTHORITY TO MAKE ANY REPRESENTATION OR WARRANTY OR AGREEMENT RELATING IN,ANY WAY TO THESE GOODS. 

### l'iu).1-.- '-"

## e**,,-~** 

### t.vY'--<:;' ; /,;7"

### v_A:L, 

# '/J.,.,->:YJ:-JA J LIMITATION OF LIABILITY TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, IN NO EVENT SHALL MANUFACTURER OR SELLER BE LIABLE FOR SPECIAL, INCIDENTAL, OR CONSEOUENTIAL DAMAGES, OR FOR DAMAGES IN THEIR NATURE OF PENALTIES RELATING TO THE GOODS SOLD, INCLUDING USE, APPLICATION, HANDLING, AND DISPOSAL, TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, MANUFACTURER OR SELLER SHALL NOT BE LIABLE TO BUYER OR USER BY WAY OF INDEMNIFICATION TO BUYER OR TO CUSTOMERS OF BUYER, IF ANY, OR FOR ANY DAMAGES OR SUMS OF MONEY, CLAIMS OR DEMANDS WHATSOEVER, RESULTING FROM OR BY REASON OF, OR RISING OUT OF THE MISUSE, OR FAILURE TO FOLLOW LABEL WARNINGS OR INSTRUCTIONS FOR USE, OF THE GOODS SOLD BY MANUFACTURER OR SELLER TO BUYER, ALL SUCH RISKS SHALL BE ASSUMED BY THE BUYER, USER, OR ITS CUSTOMERS,TO THE EXTENT CONSISTENTWITH APPLICABLE LAW, BUYER'S OR USER'S EXCLUSIVE REMEDY, AND MANUFACTURER'S OR SELLER'S TOTAL LIABILITY SHALL BE FOR DAMAGES NOT EXCEEDING THE COST OF THE PRODUCT, If you do not agree with or do not accept any of directions for use, the warranty disclaimers, or limitations on liability, do not use the product, and return it unopened to the Seller, and the purchase price 

### will be refunded. (NEW)

3

## PRIA 2 - 21 Day Content Screen Review Worksheet (EPNOPP Use Only) 

# 7 Q 

### 3/23/09 

### 21 Day Screen Start Date: 

## -:-_-'-_-"/,:-I-c-n'I,,O=- ___

## ~~ __,_:. Experts In-Processing Signature: 

# B c 

## 'P- Date 

## 7-::z.3-/0 

### Fee Paid: Yes

## ~ Divisionmanagement contacted on issues No Yes Date
EPAReg Number3-513!3-1-G- EPAReceipt Date:

# 7
- / '7

- f 

### 0 Items forReview Yes No N/A* 

### 1 Application Form (EPA Form 

### 8570-1)(link to form) signed & 

### complete 

# X including packagetype Confidential Statement ofFormula all boxes completed, f0011 

### signed, and 

# X dated (EPA Form 

### 8570-4) (Link to form) 2 a) All inerts (link to http://www.epa.gov/opprdOOllinerts/), yes no including fragrances, approved for the proposed uses (see 

# X Footnote A) 

### 3 Certificationwith Respectto Citation ofData (EPA Form 8570-34) (Link to 

### .L 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 yes no to pay statement included. (see Footnote B)


### IL 

## -" ;dh , a letter ,C 

### ,';, ,for' ,use only. r' 

### 's Exemption Statement (EPA Form 

### 8570-27)(Link to form) 

# K 4 

### and signed (N/A 

### ifsource is unregistered or applicant owns the Ch;;'a]) Data Matrix (EPA Form 

### 8570-35) (Link to form) both intemal and external copies (PR

### 98-5) (Link to PR

### 98-5) completed ffild signed (N/A if

### 100% 

# L
5 yes no 

## .«,.' a) Selective Method (Fee ;use)

b) Cite-All (Fee category experts use) :.;; 

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

## }

..... ;; 

### 5 Copies ofLabel (linktohttQ:/I"",,"vw.ena.gov/ol!nfcadlllabelin2lIrmD 

### 6 

### (Electronic labels on CD are encouraged and guidance is available)( linkto 

# >Z 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) 

# X
Notice ofFiling (linkto 

### 8**htt~:lIwww.eJ1a.gov/nesticides/regulating/toleranee** 

### netitions.htm) included with petitions (linkto http://www.epa.aov/pesticides/regulating/tolerances.htm)**~** 

### 9 If

### applicable for conventional applications, reduced riskrationale (link to ",-' 

### http://www.epa.gov/opprdOOllworkplan/reducedrisk.html) Required Data (linkto 

# >< htt)2:/Jwww

### ,cl!a.gov /ncsticidesl regulatin2ldata 

### reguirements.htm) and/or datawaivers. See Footnote C.

a) 

### List study (or studies) not included with application

,


### 10

,



### 2

### Comments:



# *NI A - Not Applicable

Footnotes A. 

### During the 21 day initial content review, all eSFswill be reviewed to determine whether all inerts listed, including fragrances, are approved for the proposed uses. Ifan 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. or2) provide the datato support OPP approval ofthe inert or 3) withdrawthe application. Removing or substituting an inertingredient will require anew eSFand may require submission ofdata. All information, forms, data and documentationresolving the inert issue must have been received bythe Agency orthe application withdrawn within the 21 day period, otherwise, the Agency will reject the application as described below. To successfully complete this aspectofthe 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 [linkto http://\VWW.epa.gov/opprdOOllinerts/lists.htmlJ and ifthe inert is not approved, to obtainthe necessary inert approvalpriorto submitting an application to register a pesticideproduct containing that inert ingredient. Someinert ingredients are no longer approved for food uses or certain types ofuses. The name and/or CAS number on a CSFmust match the name and CAS number on this web site. Simple typographical errors in the name or CAS numberhaveresulted in processing delays. Ifan inert is not listed onthe inertingredient web site and the applicantbelieves thatthe inert has been approved, the applicant should contact the Inert Ingredient Assessment Branch (lIAB) at inertsbranch@epa.gov and resolve the issue. Copies ofthe correspondence with lIAB resolvingthe issue should accompany the application. All new inerts except PIP inerts arereviewed bylIAB. 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 shouldbe directed to the Chiefof Microbial Pesticides Branch [Linkto http://www.epa.gov/oppbppdl/biopesticides/contacts bppd.htm

## J. When a brand, trade, orproprietary name ofan inert ingredient is listed on a CSF, additional information suchas an alternate name oftheinert, CAS numberor other information [link to http://www.epa.gov/opprdOOI/inerts/tips.pdfl must also be included to enable the Agencyto determine ifithas been approved. Eachcomponent ofan inert mixture (including a fragrance) must be identified. In some cases, the supplier ofthe mixture or fragrance mayneed to provide this information to the Agency. Prior to the Agency'sreceipt ofan application, applicants mustarrange with a proprietary mixture or fragrance suppliertoprovidethe component information to the Agency orpromptly upon EPA'srequest. Ifthe inert ingredients in a proprietaryblend (including fragrances) cannot or arenot identified orprovided within the 21-day content reviewperiod, the Agency will rejectthe application. During the 21 day content review, applicants should submit information to the individual identified by the Agencywhen the applicant is informed ofan unapproved inert. Unapproved Inerts Identified on CSFs All applications except conventional newproducts and PIPs Once an unapproved inertis identified on a CSF, the Agencywill contact the applicantwith the following options: 1. Correct the application by, for instance, correcting the inert's identityor CAS number, providing documentation thatthe inerthas been approved, or removing the unapproved inert from the CSF orreplacing itwith one thatis approved for the application's uses; or 2. Submitthe information and data needed for theAgencyto approve the unapproved inert. Ifthis option is selected and implemented, the Agency may requestan extension in the PRIA decision reviewtimeframe to accommodate the inert review/approval process; 4

### 3. Withdrawthe application (the Agency retains 25% ofthe full fee for the fee category estimated); or Ifnone ofthese options is selected and implemented by the applicant within the 21 day contentreviewperiod, the Agency will reject the application and retain 25% ofthe full fee ofthe category identified. ConventionalNewProduct Applications When the Registration Division identifies an tmapproved inert on a CSFwith an application for anewproductthat 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, for instance, correcting the inert's identity or CAS number, providing documentation thatthe inert has been approved, or removing the unapproved inert from the CSF orreplacing itwith one that is approved for the application's uses; or 2. Submitthe infonnation and dataneeded for the Agency to approve the tmapproved inert, including any 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. Ifadditional fees are due, they must be received bythe Agency within the 21 day contentreview period.) 3. Withdrawthe application (the Agency retains 25% ofthe full fee for the fee category estimated); or
Ifnone ofthe above options is selected and implemented during the 21-day content-reviewperiod, the Agency will rejectthe application and retain25% of the appropriate fee for the newproduct-inert approval category. PIP Applications When the Biopesticide and Pollution Prevention Division identifies an unapproved inert on a PIP CSF and a request to approve the inert does not accompany the application, it will contact the applicant withthe following options: 1. Correct the application by, for instance, correcting the spelling orname ofthe inertto that in 40 CPR 174, or providing documentation that the inerthas been approved; or 2. Submitthe infonnation and data needed for the Agencyto approve the tmapproved inert. 

### Ifan inert ingredient tolerance exemptionpetition is required, the petition mustbe receivedbythe Agency and the B903 fee paid within the 21 day period. Ifthis option is selected and implemented, the Agency \\riU discuss harmonizing the timeframe for both actions. 5

### 3. Withdrawthe application (the Agencyretains 25% ofthe full fee for the fee category estimated); or If

### none ofthe above options is selected and implemented during the 21 day contentreviewperiod,the Agency will reject the application and retain 25%of the fee.


### B. A policy on documentation ofoffers topayis still being developed, however, for a me-too or fast track (similar/identical) new product, R300 or A530, an application without the necessary authorizations ofoffers to pay will be placed into either R30l or A531. The Agencyrecommends that authorizations ofoffers to paybe 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 applicationto the Agency. Documentation ofsuch discussions should be submitted with the studywaiver.



### 6

# R 300 and 301

100%identical

## (repack'}),~.**~V~~~Jr;;:;~~iB~~~.** {If 

### yes, it's a 100%r« DataonGroup and A and B mustbe submitted

- Group A andB cannotbe cited.


### Group A: Product Chemistry Data Guideline No. Study Title 

### 830.1550 Product Identity 

### & Composition Description 0

### fmaterialsusedtoproducethe 

### 830.1600 product 83.0.1650**Descrip~ion'of**

### fonnulation process 

### 830.1670 Discussion onthefOmiation 

### ofimpurities 830.1700 Preliminary analysis 830.1750 Certified limits (158.345) 830.1800 Enforcementanalyticalmethod

Group B: ProductChemistryData GuidelineNo. 

### StudyTitle 830.6302 Color 

### 830.6303 Physical Stale 830.6304 Odor 

### 830.6314 OxidationlReduction (Chemical incompatibility) 830.6315 Flammability 830.6316 Explodability 830.6317 Storage stability 830.6319 Miscibili!)r 

### 830.6320 Corrosion Characteristics 830.6321 Dielectric Breakdovvnvoltage 

### 830.7000 ipH 830.7100 Viscosity 830.7300 Density 

### 1 Data submitted Yes 

### No

Data submitted 

### Yes No 

# 'yJ

.,y

# R 300 and 301
New productsmustprovidea bridgingrationale document. Thebridgingdocumentdirects opp

### touse a currently registered set of6 acutetoxicity data and label; insteadof submittingproduct specific data.



### Guideline Acutetoxicity (6 pack) Cited No. StudyTitle Yes No 830.1100 Acute Oral (LD50) 

# YI 830.1200 AcuteDenna! (LD50) 830.1300 Acute Inhalation (LC50) 8302400 AcuteEyeIrritation 830.2500 AcuteDermal Irritation 830.2600 Dermal Sensitization 

# '-!J

Efficacy

- which guideline depends on theproposed labeluse and theymustcitethe datato beused forthebridgingrationale.
Guideline Cited No. Efficacy StudyTitles Yes No 810.3100 Soil Treatments for Imported FireAnts 

# ><J Livestock, Poultry, Furand Wool-Bearing 810.3200 

### Animal Treatments 

### Treatments to Control Pests ofHumans and 810.3300 

### Pets Mosquito, BlackFly, and BitingMidge 810.3400 (SandFly) Treatments 810.3500 Premises Treatments 810.3600 Structural Treatments Methods forEfficacy Testing ofTennite 

# i! 810.3800 Baits

2UN!"!,;;;Q STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460


### July 22,2010

OPP DecisionNwnber: D-437501 EPA File Symbol or Registration Number: 35935-IG ProductName: NUF ARMPICLORAM TECHNICAL EPA Receipt Date: 19-Jul-2010 EPA CompanyNumber: 35935 CompanyName: NUF ARM LIMITED WILLIAM M. MAHLBURG NUFARM LIMITED NUFARM LIMITED PO Box 13439 RTP,NC 27709- OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### SUBJECT: Receipt ofRegistration Application Subject to Registration Service Fee Dear Registrant: The Office ofPesticide Programs has received your applicationand certification of payment. Ifyousubmitted data withthis application, the results ofthe PRN-86-5 screenwill be communicated separately. During the administrative screen, the Office ofPesticide Programs has detennined 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 ActionCode: R300 NEWPRODUCT;ME-TOO PRODUCT FAST TRACK; No additional payment is due atthis time. Ifyouhave any questions, please contact the Pesticide Registration Service Fee Ombudsman at (703) 308-9362. Sincerely,

# ~~ Front End Processing Staff Information Technology & 

### Resources Management Division

# IFee 

# for Servicel 

# l{878862LThis package includes the following
@ 

# New Registration oAmendment for Division 

# OAD oBPPD @RD uStudies? ;1 

# Fee Waiver?
C 

# volpay 

# % Reduction: __ Risk Mgr. 

# []I] Receipt No. 

# s-I 878862 EPA File Symbol/Reg. No. 1 

# 35935-IG Pin-Punch Date: 1 

# 7/19/2010 This item is NOT subject to FFS action. Action Code: Parent/Child Decisions: Requested: 

# 11'i0t;D

, Granted: 

# I**,~2,DO** Amount Due: 

# $ \**~'-P** 

## S**Q~** 

# -'&7 \ DUb**J~O--Z-~** [j 

## Inert Cleared for Intended Use [J 

## Uncleared Inert in Product**~\~l** 

## h 

## Reviewer:**~** 

## ) 

# V**Il,0;I~K,** Remarks: 

## \J 

## Date: 

# -;:r

# 18Y\I

# 0

o •

### Pay.gov· Online Payment**~nJ.i.~.~_~~~~_~.~~_,**___ ""**~._.**___.._,,__'"" 

### 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: 2515JCUQ Agency Tracking ID: 74127619035 Transaction Date and Time: 07/20/201012:10 EDT Payment Summary 

### Page 1 of 1



### 1 

## 1213**6~~_re_s~~nf~~'!l~!.i.o_n** ___**.~._**...**~~s:_oun!1!!f2.r!!!.~!!9J!_,"_~,** ,_._...._**~.I!lent InfC!!:!!1.~~~** __. __ _ Account

### ~~~:~ George Meindl 150 Harvester Billing Address: Drive SWing Address 2: Suite 200 City: Burr Ridge State / Province: IL Zip JPostal Code: 60527 Country: USA**'-~** __ 11

___ _ Card Type: Master Card Payment Amount: $1,365.00 Card Number: "'*"''''*'''''''''''''''*'''1276 Transaction Date 07/20/201 0 Decision Number: and Time: 12:10 EDT Registration Number: Company Name: Nufarm Limited Company Number: 35935 Action Code: R300

# Nufarm

July 20, 2010 James Tompkins (PM-25) Document Processing Desk (REGFEE) Office of Pesticide Programs (7504P) U. S. Environmental Protection Agency Room S4900, One Potomac Yard 2777 S. Crystal Drive Arlington, VA 22202 Subject: Nufarm Picloram Technical EPA Reg. No. 

### 35935- Application for Repack Registration Fast track request
- R300 44 Dear Mr. Tompkins: Nufarm Limited GeorgeMeindl RegulatoryAffairs Manager 150 Harvester Drive, Suite 200 Burr Ridge, IL 60527 Phone: 630.455.2017 Fa.x: 630.455.2030**george.mcindl@u~.nuf3.rm.com**


### Via Overnight Courier

Nufarm Limited is interested in registering the subject product. Under the Pesticide Registraflon Improvement Act of 2007 'It is our opinion that this action falls under category R300 44, new product fast track. We believe this is the appropriate category since this application is for a repack of an existing registration. Therefore, Nufarm anticipates this action requires a fee of 

### $ 1,365 for this registration request and we would anticipate a three-month review time. We have prepaid the PRIA II fee, with copy of1he pay.gov receipt included in this submission To process this request please find attached the following documentation:

• Application for Pesticide
- EPA form 8570-1 • Confidential Statement of Formula
- EPA form 8570-4 • Formulators Exem ption Statement
- EPA form 8570-27 • Proposed labeling
- four (4) copies If you should have any questions regarding this matter, feel free to contact me at 630.455.2017 or email atgeorge.meindl@us.nufarm.com.

# sr~r**~j(J G~I**  Regulatory Affairs Manager Nufarm Limned

H:\picloram\pending\Nufarm Picloram tech cover letter.doc

# &EPA

Applicant's Name and Address 

### Nufarm Limited 150 Harvester Drive Suite 200 Burr Ridge, IL 60527 Form approved. OMB No. 2070-0060, 2070-0057, 2U/O-0107, 2070-0 t22, 2070-0t64.

United states Environmental Protection Agency Washington, DC 20460 

### Formulator's Exemption Statement (40 CFR 152.85)

EPA Fite SymboURegislration Number 

### 35935-
Produci Name 

### Nufarm Picloram Technical
Date ofConfidential Statement of Formula (EPA Form 8570-4) 

### 07119/2010 As an authorized representative ofthe applicant for registration of the product identified above, I certify thaI: (1) This product contains the following active ingredient(s): 

### Picloram

(2) Ofthese, each active ingredient listed in paragraph (4) is present solely as the result ofthe use ofthat active ingredient in the manufacturing, formulation or repackaging another producl which contains that active ingredient which is registered under FIFRA Section 3. is purchased by us from another person and meets the requirements of40 CFR section 158.50(e)(2) or (3). (3) Indicate by checking (A) or (B) belowwhich paragraph applies:
71 (A) An accurate Confidentiat Statement of Formula (EPA FORM 8570-4) for the above idenlified product is attached to this stalement. That formula statement indicates, bycompany name, registrat"lon nurrtJer, and product name, the source ofthe active ingredient(s} fisted in paragraph (1). OR I (B) The Confidential Statement of Formula (CSF)(EPA Form 8570-4) referenced above and on file with the EPA is complete. current. an accurate and contains the information required on the current CSF. (4) The following active ingredients in this product qualify for the formulator's exemption.
Source Active Ingredient Product Name Registration Number 

### picIoram

Name and Title Date 

### 07119/2018 

# •**S;9C'~** 

## (!'\ 

# II \() /"',. n::... I v

## ~ EPA Form**8~_27** (Rev. 06-2004) 

### George Meindl- Reg. Affairs Mgr.**~** - - -**C;cop;;;;y;-;t-:CT""P'~A---~** Copy 2·Apjllicant copy

# ~ase read illstroctions on 'reverse berare complerlng form. Form Approved, OMS No, 2070-0060
Unit&<! SlItO$ 

# §Registration OPE' Identifier N!.IITIb4r 

# SEPA Environmental Protection Agency Amendment Washington, DC 20460 

### Other Application for Pesticide
- Section I I. Company/Product Number 2. EPA Product Menllger 3, Proposed Classification



### 35935-

## /t? James Tompkins 

# oNone 

# U R ••

tricted 4, Company/PrDducl fNamef PM. Nufarm PicIoram Technical 

### 25 5. Nome and Address of Applicant (Inc/lid, ZIP Cod., 6. Expedited Reveiw. In accordance with FfFAA Section 3(cII3!

Nufarm Limited (bWI, my product is similar or identical in composition and labeling 150 Harvester Drive Suite 200 to· Burr Ridge, IL 60527 

### EPA Reg. No. 

# o Check ifthis is • new ilddrns Product Name 

### Section -II 

# U Amendment· Explein billow. 

# U Finel printOd labels in repSOMe to Agency Jetter dalad 

# D Rasubmission in rasponse to Agancyletter daud 

# 0**~Ma Too~** **App~cation.** 

# 0 Notilication

- Explain below. 

# 0 Other

- Explain balow.**Exp)anation~** Ua", additional pagels) il neC8S$ary. !For s.ction Iond S8ction 11.1 R300 44 New product registration request**~** fast track 

### $1365.00 3 month review Repack of 

### Section
- III 1. Muarial Thill ProduC1 Win

..P'ckapd In: Child·Resistant Packaging Unit Packeging Watat Soluble Packaging 2. Typo af Container 

# d V "

# ~V" 

# 5j V
..

# ~M"" N. :X No Plastic N. Gla." 

### • Crificatlon must 11**~Yes~** No.**p~r** If**~Ya."** No. par Paper Unit Peckaging wgt. contemar Packago wgt container Other {Specifyl be$ubmittl!ld I 3. Location ofNot Content$lnformation 4. Siza{sl Retail Container [sotion of labal oiractions

X labal 

# U Container 

### 25 kg container 

# s. Mannar in Which label hr AHixed to Product 

# Ulithograph 

# U OtMr Paper**~Ued** Stanci Od

### Section**~** 

### IV I. Contact Point (Campletg itoms rJir'cUrbel/ow for fd"nrification afindividual to ba C()ntactad. if n"cfl$lllN'(. to procass thl$ tlf)Plication.}**N~.** ntle Talephone No. linclude Area Codal George Meindl (george.meindl@us.nufarm.com) 

### Regulatory Affairs Manager 

### 630.455.2017· Certification 

# .Is'**oat~** ApPlicedon Icertify that the statamants Ihave made on this rorm end e" ottechment, thereto ere we. accurate and**Compl,~l!"" R~vK**  , I I acknowledga that any kl)owiinglly false ar misleading stalemenl meybe puni.hable by fine or imprisonment0:_ 

# i (Stamped) both under applicablolew.

# A-#-~~~ . , 2. Sign**~** 3. TItle 

### ,

/' 

# Regulatory Affairs Manager. 

# I
4. TyP8d

### N.m~Qn , S_ Oat.



# 7/19/2010 George Meindl

. . EPA Form 8570·t IR.v. 3·941 preVIOUS edltrOI\$ ere ob,oleta. 

## . V,IIT.'**,~Copy**