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 copy of the 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 Statement of Formula (EPA Fonn 8570-

3 29) Included inthe Submission Package, 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~ Respect to Citation of Data (EPA 

F.'orm 8570-34) Included in the Submission Package? V- - lis a Data Matrix (EPA Fonn 8570-35) Included in the () 

Submission Package? Vt? 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 

1
NEW APPLICATIONS 

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

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

.FEP (OPPIN ENTRY) ,e'n> ifP' !/p 

(Initial & date) 

FILE ROOl\1: lk. J/a9/;() . (InftiaI & date) 

SIG: 

(Initial & date) 

FILE ROOM: _____ _ 

(Initial & date) 

;( ASSIGN TO P·M ~.j' (NO DATA) 

__ JACKET TO SHELF (DATA) 

2
Material to be added to an e-Jacket 

Reg. No. 3 S 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 of the 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 bb 3 Division: ~p 

Date: / / / j'i / (}7)J(J 

3
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 request for 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 

4
.;:,,<!-\"'£'OS7".<I~ U.S. ENVIRONME"'TAL PROTECTIO;"l AGENCY EPA Reg. Number: Date of Issuance: 

~. ft ..... Office of Pesticide Programs 

\~o'l Registration Division (750SP) 35935-83 NOV 0 9 1010 '., 1200 Pennsylvania Ave .• N.W. 

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

NOTICE OF PESTICIDE, Term of Issuance: -.X.. Registration 

_ Reregistration Unconditional 

(under FIFRA. as amended) 

Name of Pesticide Product: 

NUF ARM PICLORAM 

TECHNICAL 

"·ame and Address of Registnnt (include ZIP Code): N tv ~o.ww-.... ~~~ . h d-OU ~ 1':>0 ~ . "". 

f:l"",< Q.:J.':.~ .1L "OS";J.') 

Note: Changesin labeling differing in substmice from that accepted in connection with this registration must be submitted to and accepted by the 

Registration Division priorto usc ofthe'label in eommeree. In any correspondence on this product always rererto the above EPA registration number . 

. 

On the basis of infonnation furnished by tile registrant, the above named pesticide is hereby registered/reregistered under the Federallnseetieide, Fungicide 

and Rodenticide Act. 

Registration is in no way to be construed as an endorsement or recommendation of this product by the Agency. In order to protect health and the 

environment. the Administrator, on his motion, may at any time suspend or eaneellhe registration of a pesticide in accordance with the Act. The acceptance 

of any name in connection with the registration of a product under this Act is not to be construed as giving the registrant a right to exclusive use of the name 

or to its use if it has been covered by others. 

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

that you: 

Submit andlor cite all data required for registration of your product under FIFRA sec 3( c )(5) when the 

Agency requires all registrants of similar products to submit such data; and submit acceptable responses 

required for registration review of your product under FIFRA section 3(g). 

The requested draft label as submitted is not acceptable. It will be acceptable if the following changes to 

the label are made before shipping any product: 

a. Change the product registration number to "EPA Reg. No. 35935-83". 

b. Add the establishment number. 

c. Add the batch number to all products in disposable containers before shipment. 

d. On page 2, under >!DlRECTIONS FOR USE'r, change the fourth sentence starting with "Uses for 

which the USEPA has accepted, etc." to "This product may be used 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 submission requirements to 

support such use(s), and 2. End-use products have EPA an approved stewardship program in place. 

e. On page 3, under "WARRANTY DISCLAIMER", add to the second sentence "TO THE EXTENT 

CONSISTENT WITH APPLICABLE LAW" before" ... ASSUMED BY BUYER OR USER." 

Pagelof2 

5
A stamped accepted label with comments is enclosed for your files. 

Submit one copy of the revised final printed label for the record before the product is released for 

shipment. 

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

with FIFRA section 6(e). Your release for shipment of the product constitutes acceptance of these 

conditions. 

Please contact Phil Errico at 703-305-6663/ elTico.ghili1201ega.com . 

Sig"'t"{'ofAPt~ Date: 

NOV 0 9 1010 

JameS~Om~Oduct Manager (25) 

Herbi .Ide B~anch, Registration Division (7505P) 

EPAForm:8570 -6 ; 

\. 

Encloseure': Label stamped "Accepted With Comments". 

Page2of2 

6
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. 

(If you 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 0 9 1010 

Under the Federall: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. 

7
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 af the 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 of excess pesticide, 

spray mixture, or rinsate is a violation of Federal law. If these 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 by state 

and local authorities. Offer for recycling, if available. Offer for reconditioning, if appropriate: If drum 

cannot be recycled or reconditioned, puncture and dispose of in a secure sanitary landfill, cr 0'1 other 

2 

8
procedures 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 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. 

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 

9
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. 

(If you 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. 

1 

10
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 of the 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 

HAN DUNG 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. If these wastes cannot be disposed of by use 

according to label instructions, contact your state pesticide or environmental control agency, or the 

hazardous waste representative at the nearest 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 if allowed by stat.: 

and local authorities. Offer for recycling, if available. Offer for reconditioning, if approprial e. If drum 

cannot be recycled or reconditioned, puncture and dispose of in a secure sanitary landfill, ('r by other 

2 

11
procedures 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 

12
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 ~ Division management contacted on issues No Yes Date 

EPA Reg Number3-513!3-1-G- EPA Receipt Date: 7 - / '7 - f 0 

Items for Review Yes No N/A* 

1 Application Form (EPA Form 8570-1 )(link to form) signed & complete X including package type 

Confidential Statement of Formula 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 

Footnote A) X 

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

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

Certificate and data matrix consistent 

If applicant 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 if source 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 of Label (link to httQ:/I"",,"vw.ena.gov/ol!nfcadlllabelin2lIrmD 

6 (Electronic labels on CD are encouraged and guidance is available)( link to 

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

) 

I 

13
7 Is the data package consistent with PR Notice 86-5 (link to PRN 86-5) X 

Notice of Filing (link to 

8 htt~:lIwww.eJ1a.gov/nesticides/regulating/toleranee netitions.htm) included 

with petitions (link to 

http://www.epa.aov/pesticides/regulating/tolerances.htm) ~ 

9 If applicable for conventional applications, reduced risk rationale (link to ",-' http://www.epa.gov/opprdOOllworkplan/reducedrisk.html) 

Required Data (link to 

>< htt)2 :/Jwww ,cl!a.gov /ncsti cidesl regulatin2ld ata reguirements.htm) and/or 

data waivers. See Footnote C. 

a) List study (or studies) not included with application , 

10 

, 

2 

14
Comments: 

* NI A - Not Applicable 

Footnotes 

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

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

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

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

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

mistakes on the eSF, etc. or 2) provide the data to support OPP approval of the inert or 3) 

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

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

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

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

application as described below. 

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

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

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

3 

15
site [link to http://\VWW.epa.gov/opprdOOllinerts/lists.htmlJ and if the inert is not 

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

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

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

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

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

delays. 

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

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

Branch (lIAB) at inertsbranch@epa.gov and resolve the issue. Copies of the 

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

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

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

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

Microbial Pesticides Branch [Link to 

http://www.epa.gov/oppbppdl/biopesticides/contacts bppd.htm J. 

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

additional information such as an alternate name ofthe inert, CAS number or other 

information [link to http://www.epa.gov/opprdOOI/inerts/tips.pdfl must also be included 

to enable the Agency to determine if it has been approved. Each component of an inert 

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

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

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

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

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

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

Agency will reject the application. 

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

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

Unapproved Inerts Identified on CSFs 

All applications except conventional new products and PIPs 

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

applicant with the following options: 

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

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

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

approved for the application's uses; or 

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

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

request an extension in the PRIA decision review timeframe to accommodate 

the inert review/approval process; 

4 

16
3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none ofthese options is selected and implemented by the applicant within the 

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

25% of the full fee of the category identified. 

Conventional New Product Applications 

When the Registration Division identifies an tmapproved inert on a CSF with an 

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

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

following options: 

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

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

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

approved for the application's uses; or 

2. Submit the infonnation and data needed 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. If additional fees are due, they must be received by the 

Agency within the 21 day content review period.) 

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

category estimated); or 

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

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

the appropriate fee for the new product-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 with the following 

options: 

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

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

approved; or 

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

tmapproved inert. If an inert ingredient tolerance exemption petition is 

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

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

Agency \\riU discuss harmonizing the timeframe for both actions. 

5 

17
3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

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

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

the fee. 

B. A policy on documentation of offers to pay is still being developed, however, for a 

me-too or fast track (similar/identical) new product, R300 or A530, an application 

without the necessary authorizations of offers to pay will be placed into either R30l or 

A531. The Agency recommends that authorizations of offers to pay be submitted with 

other PRIA applications to avoid delays in the Agency's decision. 

C. Biopesticide applicants are advised to contact the Agency and discuss study waivers 

prior to submitting their application to the Agency. Documentation of such discussions 

should be submitted with the study waiver. 

6 

18
R 300 and 301 

100% identical (repack'}),~. ~V~~~Jr;;:;~~iB~~~. {If yes, it's a 100% r« 

Data on Group and A and B must be submitted - Group A and B can not be cited. 

Group A: Product Chemistry Data 

Guideline No. Study Title 

830.1550 Product Identity & Composition 

Description 0 f materials used to produce the 

830.1600 product 

83.0.1650 Descrip~ion'of fonnulation process 

830.1670 Discussion on the fOmiation of impurities 

830.1700 Preliminary analysis 

830.1750 Certified limits (158.345) 

830.1800 Enforcement analytical method 

Group B: Product Chemistry Data 

Guideline No. Study Title 

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 Breakdovvn voltage 

830.7000 ipH 

830.7100 Viscosity 

830.7300 Density 

1 

Data submitted 

Yes No 

Data submitted 

Yes No 

'yJ 

.,y 

19
R 300 and 301 

New products must provide a bridging rationale document. The bridging document directs 

opp to use a currently registered set of 6 acute toxicity data and label; instead of 

submitting product specific data. 

Guideline Acute toxicity (6 pack) Cited 

No. Study Title Yes No 

830.1100 Acute Oral (LD50) YI 

830.1200 Acute Denna! (LD50) 

830.1300 Acute Inhalation (LC50) 

8302400 Acute Eye Irritation 

830.2500 Acute Dermal Irritation 

830.2600 Dermal Sensitization '-!J 

Efficacy - which guideline depends on the proposed label use and they must cite the data to 

be used for the bridging rationale. 

Guideline Cited 

No. Efficacy Study Titles Yes No 

810.3100 Soil Treatments for Imported Fire Ants ><J 

Livestock, Poultry, Fur and Wool-Bearing 

810.3200 Animal Treatments 

Treatments to Control Pests of Humans and 

810.3300 Pets 

Mosquito, Black Fly, and Biting Midge 

810.3400 (Sand Fly) Treatments 

810.3500 Premises Treatments 

810.3600 Structural Treatments 

Methods for Efficacy Testing ofTennite i! 810.3800 Baits 

2 

20
UN!"!,;;;Q STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

July 22,2010 

OPP Decision Nwnber: D-437501 

EPA File Symbol or Registration Number: 35935-IG 

Product Name: NUF ARM PICLORAM TECHNICAL 

EPA Receipt Date: 19-Jul-2010 

EPA Company Number: 35935 

Company Name: NUF ARM LIMITED 

WILLIAM M. MAHLBURG 

NUF ARM LIMITED 

NUF ARM LIMITED 

PO Box 13439 

RTP, NC 27709-

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

SUBJECT: Receipt of Registration Application Subject to Registration Service Fee 

Dear Registrant: 

The Office of Pesticide Programs has received your application and certification of 

payment. If you submitted data with this application, the results of the PRN-86-5 screen will be 

communicated separately. During the administrative screen, the Office of Pesticide 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 Action Code: R300 

NEW PRODUCT;ME-TOO PRODUCT FAST TRACK; 

No additional payment is due at this time. 

If you have any questions, please contact the Pesticide Registration Service Fee 

Ombudsman at (703) 308-9362. 

Front 

Sincerely, 

End Processing 

~~ Staff 

Information Technology & Resources Management Division 

21
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 • 

22
23 *Product ingredient source information may be entitled to confidential treatment*
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 J Postal 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 

24
Nufarm 

July 20, 2010 

James Tompkins (PM-25) 

Document Processing Desk (REG FEE) 

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 

George Meindl 

Regulatory Affairs 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 

25
&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 of Confidential Statement of Formula (EPA Form 8570-4) 

07119/2010 

As an authorized representative of the applicant for registration of the product identified above, I certify thaI: 

(1) This product contains the following active ingredient(s): 

Picloram 

(2) Of these, each active ingredient listed in paragraph (4) is present solely as the result of the use of that 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 of 40 CFR section 158.50(e)(2) or (3). 

(3) Indicate by checking (A) or (B) below which 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, by company name, registrat"lon nurrtJer, and product name, the source of the 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 \ () 

EPA 

/"',. 

Form 8~_27 

n::... 

(Rev. 

I v 

06-2004) 

~ George Meindl- Reg. Affairs Mgr. ~ - - - C;cop;;;;y;-;t-:CT""P'~A---~ 

Copy 2· Apjllicant copy 

26 *Product ingredient source information may be entitled to confidential treatment*
~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 o None 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 if this 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 Agancy letter 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 I ond 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 dV

" ~V" 5j V .. 

N. :X No ~M"" 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 of Not 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 U lithograph U OtMr 

Paper ~Ued Stanci Od 

Section ~ IV 

I. Contact Point (Campletg itoms rJir'cUr bel/ow for fd"nrification af individual 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 

I certify that the statamants I have 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 mey be puni.hable by fine or imprisonment 0:_ 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 

27 *Product ingredient source information may be entitled to confidential treatment*
28

*Confidential Statement of Formula may be entitled to confidential treatment*