# EPA Jacket 42750

‐ 221

# Material Sent for Data Extraction

Reg. # 

# '-1;:)'/60-.:),) 

# 1

Description: 

# YvDh -f;

# ~J;~**~** 

# 4truU 

# J C;)'F**~** 

# Material(s) Sent to Data Extraction Contractors:



# o New Stamped Label Dated

___ _

Notification Dated**~** 

# - 

# rz. -Ij

# "'''~,f. 3-//1-11



# New CSF(s) Dated 

# ¥- }"Z-ll



# o Other:



# o Deci s ion 

# #: 

# _----J'1=S'-=3'-'--1=S;

.....



# d."'---_



# o Other ActionjComments:

________ _

File this coversheet and attached materials in the jacket. It 

# must be
well organized and clipped together, NOT STAPLED. Then give the jacket with the coversheet and materials to staff in the Information
Services Center (ISe) (Room S-4900). If a jacket is full or only
available as an image, please file materials in a new jacket and bring it
down to the (ISC). F rther information please call 703-605-0716.



# Rev i ewe r:**_-/J:::....a.Q:J:,:£j=--l.):::!.,I@.SW-,£:.,.;~** 

# _____ _


# Phone: 3PS--S7;;l1 

# Division: 

# .J2.DjE..e

Date: 

# /kvff'4 •. f: (&'; '2-0/1

# UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, DC 20460

Morris Gaskins Registrations Manager 

### Albaugh, Inc.


## P.O. Box 2127 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



# AUG 1 8 2011

Valdosta, GA 31604-2127

Product Name:



### EPA Reg. No.: Subject:

EPA Decision Number:

Dear Mr. Gaskins: Propiconazole Technical



### 42750-221

Your notification dated August 12, 2011: Corrected CSF

453152

The Agency is in receipt of your Application for Pesticide Notification under Pesticide Registration Notice (PRN) 98-10. The Registration Division (RD) has conducted a review of
this request for its applicability under PRN 98-10 and finds that the action(s) requested fall
within the scope ofPRN 98-10.

The basic Confidential Statement of Fonnula (CSF) dated 8/12/2011 is acceptable as a notification and will 

### be added to the 

## regulatory file for this registration. This CSF supersedes all CSFs previously accepted for this product.

If 

### you have any questions, please contact Robert Westin by phone at (703) 305-5721 or via

email at westin.robert@epa.gov.

Sincerely,



# .**~(~~MpVV faja~.**  Joyner
Product Manager (20) Fungicide Branch Registration Division (7504P)

### Page 1 of 1

Propiconazole Tech CSF 42750-221
Ailis Gregory

to: Robert Westin
08/12/2011 10:30 AM

Cc:
Morris Gaskins
Hide Details

From: Ailis Gregory <AilisG@albaughinc.com>

To: Robert WestinIDCIUSEPAIUS@EPA

Cc: Morris Gaskins <MorrisG@albaughinc.com>

1 Attachment 

# ""t**~** 

### Propiconazole Tech 427S0-221.PDF

Good Morning, Mr. Westin.

Please see the attached notification regarding the correction of the CSF lower certified limit for Propiconazole

Technical (EPA reg# 42750-221). We believe this qualifies as a notification in accordance with PR Notice 98-10.
However, if you disagree, we can submit it as an amendment.

A hardcopy of the attached documents will be mailed today.

Have a good day.

Ailis

Ailis Gregory Regulatory Chemist Albaugh, Inc.



### PO Box 2127
Valdosta, GA 31604-2127

229-244-3288 

### ,"



### , ,,'
)



### , ,



### , , , , 

### "



### , '"'' '

# ALBAUGH

e 

# INC.

August 12, 2011

Document Processing Desk (NOTIFY)
Ms. Shaja Joyner (Team 20) Registration Division

Office of Pesticide Programs (7504P) 

### U.S. Environmental Protection Agency
Room S-4900, One Potomac Yard (South Bldg)
2777 South Crystal Dr. Arlington, VA 22202



### RE: Prop1conazole Technical
EPA Reg. No. 42750-221

Dear Ms. Joyner, Fed-X GEORGIA OFFICE

P.O. 80)( 2127
Valdosta, GA 31604-2127

229.244.3288 (Phone)

229.244.5841 (FAX)

The enclosed submission for the above referenced registration is a CSF notification to the basic CSF as approved by the Agency on 5J23/11. That approved basic CSF had a typographical error in box 14b for the

lower certified limit for propiconazole. The CSF had a lower limit of 96.61 thaI should 

### have been 93.61 which

)S the correct 3.0% less than the nominal 96.50%. The only other change was updating the registration

number in box 4 from the file symbol.

Please call if you have any questions.

Regards,

Monis Gaskins Regtstrations Manager Albaugh, Inc.**229~244~3288**

# Agr~.~~!~~lnc.
PREMIER SUPPLIER OF**OFF~PATENT** CROP PROTECTION PRODUCTS vvvvvv.albaughinc.com " '

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# NOTIFICATION

AUG 1 8 2011

OMR No. ']070-00Ri**~.2R.95**

United Stctau

# ~ Registration OPP !dantifior Numbar 

# &EPA Environmental Protection Agency Amendment Wcshington, OC 20460 

### I 

## Other

Application for Pesticide

- Section I

I. Company/Preduct Numbcr 2. EPA Product Manllger 3. Proposed C!assificlltion 

### 42750-221 S. Joyner UNona 

# [2] Rlotrictlld
4. Company/Product (Namc! 

# PM.

Propiconazole Technical 

### 20

5. Noms ond Addrass 01 App!icant (Includo ZIP Codel 6. Expedited Reveiw. In accordance with FIFRA Section 3{cI(3) 

### Albaugh, Inc. (bini, my ptoduct is similar ot identical in composition and labeling


### P.O. Box 2127 to: 

### Valdosta, GA 31604 EPA Reg. No. 

# o

ChllcJ: /1 this is. nllw oddrllSS Product Name


### Section

- II 

# 0 Amandment

- Exploin below.

# ~ Finol printud lobo!s in repsonse to Agoncy !attor dotod 

# 0**Rosubmj~sion** in responso to Agoncy lettor dotod. 

# 0 "Mo Too" Application. 

# [2] Notitication

- Exploin bulow. 

# 0 Othar

- Exploin bulow.

Explanation: Uso additional pogotsl if nocosso,y. !For s8ction I and Soction 11.1

Nolificalion to correcl typo on basic CSF per PR Nolice 98-1 0 - COrTecl bwer certified limit value of Ihe aClive ingredienl to usual 3.0% below the nominal.

This notiflcalion is consistenl wilh !he provisions 01 PR Notice 98- to and EPA regulations at 40 CFR 152.46, and no turlher changes have been made 10 Ihe labe!ing or the confiden!ia! slatemen! of lormula ollhis producl. I undersland Ihat il is a violalion 0/18 U.S.C. Sec. 1001 10 willfully make any false slalemenl to EPA. I further unders!and Ihal n this nolification is nol consislent with the terms of PR Notice 98-1 0 and 40 CFR 152.46, Ih'ls product may be in violation ot FIFRA and I mav be subiec! 10 enforcement action and oenallies under sec!ion 12 and 14 of FIFRA



### Section

- III

..!..:!!'!-,?rial Tni, Product Will 

### s.. Plckagld In:

Child-R8sistont Puckaging Unit Packuging 

## I Wot8r' Solublo Packaging 2. Typo of Container 

# [jV" @VO, 

# B V., 

# [;J

M"ol



### I No 

### I No ..I Pl8=tic No GI899



### • Certification must If ftYosft No. P?r If "Yos" No. por Poper fiber drum Unit Peck8ging wgt. contalnor PockliigD wgt conteina, ..I Othor !Sp8city) 

### be submitted

3. Locoflon ot Net Contents Inform8tion 14. SilO!=! Rotllil Contain8r J 5. Locotion ot Lob81 Oiroctions



# li: Lebel 

# U Contoin8r 

### i 25 Kg 

# Ld Attached to container

6. Monner in Which Lobel is Affixed to Product UUthogroPh 

# U Othor

oF Paper**~uod** 

### '"

, Stonci &d 

# .

,. 

### Section -IV " 

### ,



# --
1. Contoct Point ICompltlto itoms dirtlctfy bl1fow for idtlnfificotion of individuof to btl contoctod. if nocos$&ry. to proCtlSS this opplictlli6n.l 

### ,..,.,."..

Name Titlo To!ophona No. t!nclud? Aroe C<!dO)**~** Morris Gaskins Registrations Manager 229-244---3288 ' , , , , >



# . 

# .. , 

# .

Certification 6. o"i.,'**"pp~!:,ation** 

### • • 

# ·

•



### ,

I conily that tho statam8nts ! hovo moda on this form and sll ottochmonts thorato oro truo, 8CCurot8 ond comp!Bto. Roeoivt.'o' 

# ... : I

. , I acknowlodge thet any knowlinglly folso or**mi~lo8ding** statom8nt may bo punishllblo by fintl or imprisoMlant or

### ,(St~Tped) 

### , , , ,

both under IIpplicob!o Illw.


# . "

2. Signatura

# ~,-? 3. TItlo

# ~ Regislrations Manager 

# .. ,.

4. Typ8d Nsm8 

### I 5. Det8

Morris Gaskins 

### Augus112,2011



# . EPA Form 8570-' IR'v. 3-941 ProVloull odlbon" aro obsollto

. Whlto EPA File Copy longlnall

. 

## .

# FEE 

# FOR SERVICE

## DATA PACKAGE BEAN SHEET

Date: 16-Aug-2011

Page 1 of 2



## * * * 

### Registration Information 

## * * *

Registration: 42750-221

- PROPICONAZOLE TECHNICAL

Company: 42750

- ALBAUGH INC

Risk Manager: RM 20

- Shaja Joyner

- (703) 308-3194 Room# PY1 5-7327

Risk Manager Reviewer: Robert Westin RWESTIN

Sent Date:

____ _ Calculated Due Date: 18-Nov-2011

Type of Registration: product Registration

- Section 3 Decision #: 45105S

DP #: (392922)



### PRIA



### Parent DP #:

Submission #: 898535

E·Sub #:

Edited Due Date:

____ _

Action Desc: (R340) NON-FAST-TRACK (INCLUDES CHANGES TO PRECAUTJONARY LABEL STATEME

Ingredients: 122101, Propiconazole(96.S%)



### * 

## * * Data Package Information 

## * * 

## *

Expedite: 

## 0 Yes. No Date Sent: 16-Aug-20t1 Due Back:

DP Ingredient: 122101, Propiconazole

DP Title: New source of TGAI

CSF Included: • Yes 

## 0 No Label Included: 

## 0 Yes. No Parent DP #:

____ _

Assigned To Date In Date Out

Organization:**"R~D~/~T~R~B** _______ _ Last Possible Science Due Date: 19-0ct-2011

Team Name:**,C~H~E~M,---** _______ _ Science Due Date:

____ _

Reviewer Name:

__________ _ Sub Data Package Due Date:

____ _

Contractor Name:

__________ _



### * * * Studies Sent for Review 

### * * *

Printed on Page 2



### * * * Additional Data Package for this Decision 

### * * *

No Additional Data Packages



### * * * Data Package Instructions 

### * * *

Registrant has submitted alternate CSF #1 dated 6/23/1 t that describes a new source of technical grade propiconazole. This material is further
described by product chemistry data MRIDs 485195-01 and -02.

Are these studies acceptable?

Have all of the product chemistry requirements been fulfilled?
Is the alternate CSF dated 6/23/11 acceptable?

Is the material described by the alternate CSF an acceptable substitute for the technical propiconazole described by the corrected basic CSF
dated 81121t1?

Questions? Bob Westin 305-572148519501

48519502

48519501

48519501

48519502

48519501 Page 2

•**~ ~** Studies Sent for Review * * •

# g~;~r~"~!::~~;~,~,~",~.~'~'7W;~I~B~'~'/;"f.'~~~'~:::~**:r~::Y** Gregory, A, (2011) Propiconazole TGAI: Product IdentHy and Composition. Project Number: ALB11/11. Unpublished study prepared by Albaugh, Inc. 117 p. Agarwal, M. (2008) Preliminary Analyses of Five Representative
Production Batches of Propiconazole Technical Grade Active Ingredient (TGAI) to Determine % Propiconazole and 10 Quantify
its Associated Impurities. Project Number: 8012. Unpublished study prepared by Jai Research Foundalion. 168 p. Gregory, A. (2011) Propiconazole TGAI: Product Identity and Composition. Projecl Number: ALBll 111. Unpublished study prepared by Albaugh, Inc. 117 p. Gregory, A. (2011) Propiconazole TGAI: Product Idenmy and Composition. Project Number: ALBll/11. Unpublished study prepared by Albaugh, Inc. 117 p. Agarwal, M. (2008) Preliminary Analyses of Five Representative
Production Balches of Propiconazole Technical Grade Active Ingredient (TGAI) to Determine % Propiconazole and to Quan1ify
its Associated Impurities. Project Number: 8012. Unpublished study prepared by Jai Research Foundation. 168 p. Gregory, A. (2011) Propiconazole TGAI: Product Identity and Composition. Projecl Number: ALBll Ill. Unpublished study prepared by Albaugh, Inc. 117 p. Decision#: (451056)

830. 1550lProducl Iden1ity and composition

830. 1800lEnforcemen1 analytical
method

830. 1750/Certified limits

830. 1600toescriplion of materials
used to producelhe product

830.1700/Preliminary analysis

830.1620/Description of production

process

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



### GREG MULHALL

ALBAUGH 

### INC

1525 NE 36TH STREET ANKENY, IA 50021 July 1,2011

Report of Analysis for Compliance with 

### PR Notice 86-5 OFFICE OF PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES



# y Z- 1 

# '5 '()

- '2-2 J



# 1) 

# 1..15 

# loS" 

# 0

Thank you for your 

### submittal of27-JUN-l1. Our staff has completed a preliminary analysis of the material. The results are provided as follows:

Your submittal was found to be in full compliance with 

### the standards for submission of

data contained in PR Notice 86-5. A copy of your bibliography is enclosed, annotated with

Master Record ID's (MRIDs) assigned to each document submitted. Please use these numbers in

all future references to these documents. Thank you for your cooperation. If you have any questions concerning this data submission, please raise them with the cognizant Product Manager, to 

### whom the data have been released.CORPORATE OFACE

" 1525 NE 36th Street

Ankeny. IA 5002.1

515.964.9444 (Phone)

800.247.8013 (Toll Free)

515.964.7813 (FAX)

# A~BAUGH,**Ir\l~.** GEORGIA OFFICE

P.O. Box 2.127

Valdosta. GA 31604-212.7

2.2.9.244.3288 (Phone)

2.29.244.5841 (FAX)



### 486196-00

June 23, 2011

Document Processing Desk (AMEND)
Ms. Shaja Joyner (Team 20) Registration Division
Office of Pesticide Programs (7504P)
U.S. Environmental Protection Agency
Room S-4900, One Potomac Yard (South Bldg)
2777 South Crystal Dr. Arlington, VA 22202

RE: Propiconazole Technical
EPA Reg. No. 42750-221

Dear Ms. Joyner, 

### Fed-X

The enclosed submission for the above referenced registration is a proposed amendment to add an altemate manufacturing source. Documents in support of this submission are detailed on the attached transmittal

page.

Albaugh believes this submission qualifies as a PRIA R340 action with $3,617 fee and 4 month review time.

Please caJl 

### if you have any questions.

Regards,

Morris Gaskins RegIstrations Manager Albaugh, Inc.


### 229-244-3288



# Agri

# ~!.!'_~=,
PREMIER SUPPLIER OF OFF-PATENT CROP PROTECTION PRODUCTS www.albaughinc.com

## TRANSMITTAL DOCUMENT

Name and address of submitter:

Albaugh, Inc.
P.O. Box 2127 Valdosta, GA 31604-2127

Company Official: Morris Gaskins



### Telephone: (229) 244-3288

Regulatory action for which this package is submitted:

Alternate manufacturing source for PROPICONAZOLE TECHNICAL

Transmittal Date: June 23, 2011

List of items submitted:

• Transmittal page

• Cover letter



### • 8570-1 application form

• 8570-34 Certification With Respect to Citation of Data form



### • 8570-35 Data Matrix (internal use copy)



### • 8570-35 Data Matrix (public file copy)

• Alternate CSF 

## # 1 (2 copies)

• PRIA 

### fee check copy 

### & form



### 48619501- Series 830-A 

### Product Identity and CompOSition, 

### Description of Materials Used to Produce the Product, Description of Formulation Process, Discussion of Formation of Impurities, Certified 

### Limits, and Enforcement Analytical Method (OPPTS Guidelines 830.1550, 830.1600, 830.1620, 830.1670, and 830.1750) (3 copies)

48519502. Series 830-A Preliminary Analysis and Enforcement Analytical Methods (OPPTS Guidelines


### 830.1700 and 830.1800) (3 copies)

# .j~ RE: Your Submission to EPA (42750-221) "'f!zSFfi!;' Morris Gaskins to: Fiker Getachew 07/01/2011 12:09 PM

_____**~_~"_"~_~~** ____ <

_____**~~n**

_ _**,,_~_.** ___**m~,.,** __**~_~"** __ _ 1 attachment 

# "'1

Propiconazole Study Pages 2 & 3.PDF



### Ms. Fiker,

Attached are the pages with signatures. We also noticed that page 3 was not signed so are including those also 

### if needed.

My apologies for the delay and inconvenience.

Thanks for your help and have a great holiday weekend.

Regards,

Morris Gaskins

-----Original Message-----
From: Fiker Getachew [mailto:Getachew.Fiker@epamail.epa.gov]
Sent: Friday, July 01, 2011 11:18 AM
To: Carolyn Miter
Cc: Morris Gaskins Subject: Fw: Your Submission to EPA {42750-221}

Dear Mr. Gaskins,

This email is regarding your amendment package for Propiconazole Technical{Reg# 42750-221). We have found the following 86-5 deficiency
with the data you submitted that is in. support of your amendment.

Study 02: "Preliminary Analysis of Five Representative Production
Batches". "You Failed to sign the statement of data confidentiality claims included on page 2 of the study".

Please send me the revised copy of the page through email or yoU can fax
it to 703-305-5060/Attn: Fiker Getachew.

please give me a call if you have any questions.

Thank you

Fiker Getachew
EPA Contractor
703-305-6472

## Script for Rejection Phone calls

Contact Name: 

# \1",- r ,s 

# G L" 

# 'Ie, nS



## Phone 

## #: 'L 

## L"1

- 

# L'i 

# '-I

- '5 

# '-8' 'is

Email: fY1

# ~~r\s 

# d Q oc\ 

# bc<u3'" inC-

. C

# ~.M First Call1Imtials: Second Call1Imtials:

Date: t9 

# b 

# l'?2 Date: Time: Time:

This is,

__

# .c~)**::!IW)::b..Sed.[_Ge=c.::...-.::-\",~"c,,-,h=12"';y)"""'--"** EPA contractor.

I'm calling regardin your submission in support of )

# ~~~L~~2£'**~~kL~' ~~0u'~nuLQ~le~~-~~'~l~** 

Volnme/Study Tide:

Additional volumes continued on back of page: Yes or No

Application Package: Yes

# o~

These deficiencies have been approved by EPA.
The corrections can be faxed to 703-305-5060/Attn:

_______ _



## Second Call1Email:

If 

## we do not receive the corrections by

, we will process

your submission, accordingly. Please direct all future calls and correspondence to the appropriate EPA Risk Manager.

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



### June 28, 2011

opp 

### Decision Number: D-451056

EPA File Symbol or Registration Number: 42750-221

Product Name: PROPICONAZOLE TECHNICAL

EPA Receipt Date: 27-Jun-2011

EPA Company Number: 42750 Company Name: ALBAUGH INC

GREG MULHALL

ALBAUGH INC

1525 NE 36TH STREET ANKENY,IA 50021 OFFICE OF PREVENTION, PESTICIDES 

### A.,"·m

TOXIC SUBSTANCES



### SUBJECT: Receipt of Registration Amendment Subject to Registration Service Fee

Dear Registrant:

The Office of Pesticide Programs has received your amendment 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 determined that this Action is subject to a 'Pesticide Registration Service Fee as defined 

### in

the Pesticide Registration Improvement Act.

The Action has been identified as Action Code: R340

NON-F AST- TRACK (INCLUDES CHANGES TO PRECAUTIONARY LABEL STATEMENTS;SOURCE CHANGES TO AN UNREGISTERED SOURCE);

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.

Sincerely,

### -~ Front End

# P~ Staff

Infonnation Technology & Resources Management DivisionS)'4"·-0"'0«""'"r,";t,:s:\''''",'1w'"'''\<;1'"o'fl','q',,,,"?;10:,,,,.·'i0:<';,.,.;,."'-'v)'<,.C4!PRO'....CompanyNameTelephoneNumberDecisionNumberU.S.EnvironmentalProtectionAgencyOfficeofPrevention,PesticidesandToxicSubstancesPesticideRegistrationImprovementActFeePaymentPleasefiJIintheformcompletelyClickSubmitDatatomakeyourpaymentIf;F19_ .,;:;"C<ContactNamelI"lifr"/.$(;C.."krMIIEmailAddressRegistrationNumberI/'1.,rr/$51@o../b<>-,-,,jt..i'"lC.<:.0-"1I.if.2-7!>C-.,:;.:L/•PaymentAmount,-IC0/1.,,·.2&>Ie:.VecAAi/II"J-f:2-7!>O_;<,3"fo&7'""rF"r/"l".""t;.,. .,..nhHELOWERCORNEROFTHISCHECKMUSTFADETEMPORARILYWHENWARMEDBYTO'UCHORFRlcndN:.JlJJjaughInc.1525:N.'E.36tliSt.Jtweeny,Iowa50021WELLSFARGO;BANK,N,A.VANWERT.OH800·289·3557!l6-332f412083840Threethousandsixhundredseventeenandxx1100DollarsDATE5/512011,AMOUNTPAYTOTHEDRDEROF:PRIAUSA--------.,,"',----"-----*************3.617.00•.v.......&.,,"-'AUTHOflIZEDSIGNATURE"'.''"._--------..._-,------,.JlIljaugfiInc.083840VENDORNO.:11485NAME:PRIAINVOICEREFERENCEINV.DATEINV.AMOUNTDISCOUNTADJ.AMT.AMT,'"."",00Pro()C.OI\p-<-D1c'1ect,,,,;C"'-7S""O-;2...7--,I!.3014<f'"r...11:tv..-f:50vrce.,·"·.,,·,"TOTALS:3,617.000.003.617.00•SUPERIORPRESS1

# IFee for Servicel 

# ."'7'

(898535GThis package includes the following



# ° New Registration

@Amendment



# I 0 

# Studies? 0 

# Fee Waiver?



# I °volpay 

# % Reduction:

__ for Division



# °AD

°BPPD @RD

Risk Mgr. 

# []QJ

Receipt No. 

# s-I 898535



# o EPA File Symbol/Reg. No. 1 

# 42750-221

Pin-Punch Date: 1 

# 6/27/2011

This item is NOT subject to FFS action.

Actro-n-eo-de: 

# [I Parent/Child Decisions: 

# l

Requested: 

# I 23/.{D 

# i

Granted: 

# I RJl-D ,



# Amount Due: 

# $ 3,11; 

# I 

# J I'

## ~-------------~' ------------



# u Inert Cleared for Intended Use 0 

# Uncleared Inert in Product

Reviewer: 

# CZr'"

LOA

# ~ Date: 

# (oh'i,//I

Remarks:

# U~ r I

# PRIA 2 - 21 Day Content Screen Review Worksheet
(EPA/OPP Use Only)



### 3123109

21 Day Screen Start Date: 

# C;

- Z 7 - 

## II
Experts In-Processing Signature: r"1 

# E dtdof**,/,.r(,7~'"** 

### Date 

## & - 2.f -/ / Fee Paid: Yes


### Division management contacted on issues No Yes Date

EPA Reg. Number: 

# 42. 7 S-O

_ 'Z L EPA Receipt Date: 

# G -2.

1

2



### 3



## 4

5 Items for Review

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

### complete including package type Yes 

## No N/A*



### Confidential Statement of Formula all boxes completed, form signed, and 

# )r

dated Form

. to a) All inerts (link to httpJ/www.epa.gov/opprdOOllinerts/), including

, approved for the proposed uses (see

Footnote

Certification with Respect to Citation 

# or Data (EPA Form 8570-34) (Link to 

## l-- fann) completed and signed (N/A 

## if 100% repack) 

## 1'\

Certificate and data matrix consistent

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

to pay statement included. (see Footnote B) yes 

## no



## Exemption

# ~~~~~~t~O-;f;;o:::fln;:;;-) 

# ---Jf----t----t----1

and signed (N/A 

### if source is unregistered or applicant owns the

Data Matrix (EPA Ponn 8570-35) (Link to form) both internal and external copies (PR 98-5) (Link to PR 98-5) completed and signed (N/A 

### if 100% 

# X

Selective Method

b) Cite-All (Fee category experts use)

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

5 Copies of Label (link to http://www.epa.gov/oppfeadillabeling/lrml)

6 (Electronic labels on CD are encouraged and guidance is available)( link to http://www.epa.gov/pesticides/regulating/registering/submissions/index.htm#!abels



### I

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

# Y/

(



### Notice of Filing (link to 

## 8 httQ:/lwww.eI!3.gov/l!esticidesiregulatin2ltolerance }!etitions.htm) included 

# X with petitions (link to 

### http://www.epa.eov/pesticides/reeulatinWtolerances.htm)

9 

### If applicable for conventional applications, reduced risk rationale (link to 

# X http://www.epa.gov/opprd001/workplan/reducedrisk.html)



## Required Data (link to

h 

### tt(!:lIwww 

## .ena.go v I(!esticides/regulatinl!lda ta 

## reguirements.htm) and/or
data waivers. See Footnote C.

a) 

### List study (or studies) not included 

### with application



### 10

2

### Comments:



# A M0Cl. r<) 

# e.n-t- 

# C? Lc 

# s;: -"



# "6b-S 

# fCJcss

* N/A

- 

### Not Applicable

Footnotes



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

whether all inerts listed, including fragrances,**ar~** 

### 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 CSF, 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 CSF and may require submission of data. All infonnation, fonus, data and

documentation resolving the inert issue must have been received by the Agency or the application withdrawn within the 21 day period, otherwise. the Agency will reject the application as described below.

To successfully complete this aspect of the 21 day initial content screen, applicants are strongly encouraged to verify that all inert ingredients have been approved for the application's uses even if a 

### product is currently registered by consulting the inert Web

3

### site [link to http://www.epa.gov/opprdOOllinerts/lists.html] and 

### 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 (1IAB) at inertsbranch@epa.gov and resolve the issue. Copies of the correspondence with llAB resolving the issue should accompany the application. All

new inerts except PIP inerts are reviewed by llAB. The IIAB 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/oppbppdllbiopesticides/contactsbppd.htm]

.

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

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

infonnation [link to http://www.epa.gov/opprdOOllinerts/tips.pdfJ 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,**applic~nts** 

### 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)

carmot 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 shpuld submit information to the individual

identified by the Agency when the applisant is -iflformed 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

### 3. Withdraw the application (the Agency retains 25% of the full fee for the fee
category estimated); or

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

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

25% of the full fee of the category identified.

Conventional New Product Applications

When the Registration Division identifies an unapproved inert on a CSF with an application for a new product that the applicant has not identified as requiring an inert approval (R311, R312 or R313), it will contact the applicant with the following options:

1. 

### Correct the application by, 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 unapproved 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

If none of the above options is selected and implemented during the 21-day
content-review period, the Agency will/eject the application and retain 25% of

the appropriate fee for the new**product~,!nert** 

### 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 CFR 174, or providing documentation that the inert has been approved; or

2. Submit the infonnation and data needed for the Agency to approve the unapproved inert. If an inert ingredient tolerance exemption petition is required, the petition must be received by the Agency and the B903 fee paid

within the 21 day period. If this option is selected and implemented, the Agency will discuss harmonizing the timeframe for both actions.

5

### 3. Withdraw the application (the Agency retains 25% of the full fee for the fee
category estimated); or

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

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

B. 

### A policy on documentation of offers to 

### pay is still being developed, however, for a

me-too or fast track (similar/identical) new product, R300 or A530, an application
without the necessary authorizations of offers to pay will be placed into either R301 or A531. The Agency recommends that authorizations of offers to pay be submitted with
other PRlA 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.

6PI •••• ,..d 

### m. rructioM on l'even. b.fo,. com 

# t foLm' Flilrm Alillilro

... e5!. ilB No ?n70.00Rr. • '·'8·95

United States 

# o

Registration opp Identifier Number 

# &EPA Environmental Protection Agency 

### I Amendment
Washington, DC 20460 

### Other

Application for Pesticide

- Section I

I. Company/Product Number 2. EPA Product Manager 3. Proposed Clessification 

### 42750-221 S. Joyner 

# o

None 

# o

Restricted

4. Company/Product IName) 

# PM.

Propiconazole Technical 

### 20

5. Namll and Address of Applicant (Inc/uri" ZIP Cod,,) 

### 6. Expedited Reveiw. In accordance with FIFRA Section 3{cH3) 

### Albaugh, Inc. (b)(il, my product is similar or identical in composition and labeling


### P.O. Box 2127 to:


### Valdosta, GA 31604-2127 EPA Reg. No. 

# D

Ch"ck if thrs is a nDW Dddross Product Name


### Section

- II 

# 0 Amendment· Explllin balow. 

# U Rnel printed labels in rllpsonsa to Agency lattllr dlltlld 

# D Resubmission in rasponse to Agency letter deted 

# D**~Me** Too· Application. 

# D Notification· Explllin below. 

# D Dthur

_ Expillin below.

Exp)anation; USII additionol pege!s) if nucessllry. (For section I and Saction 11.1

Amendmenl to add alternate manufacturing facilily as C8F allernate # 1

This amendment is being submitted under the PRIA II Fee for SeNice program as a EPA Class # R340 applicalion with a 4 month review time and a fee of $3,617.

Albaugh check # 83840 for Ihal amount has been submilled to the EPA lockbox concurrently wilh this application.



### Section

- III

1. Meteriel Thil Product W!U Be Peckag.d In:

Chiid-RlIsistllnt Packaging Unit Peckaging Water Soluble Packaging 2. Type of Conteiner 

# SjV" Sjv"

# ~ V"



# . gM""

.f 

### N, .f 

### N, ./ Plastic 

### N, Glass


### * Certification must It ·Yes· No. per If ·Yes· No.**p~r** Paper

Unit Packaging wgt. conteiner Puck!lga wgt contllJnllr Othor (Specify) 

### btl submitted

3. Location ot Net Contents Information 4. Si:o:e(s) Rlltail Container 5. Location of Label Directions



## [{J Lsbel 

# U Container bulk 

# f::::j On label aHached to container

6. Mllnnor in Which Lebel is Affixad to Product 

# t:j

Uthograph 

# 0 Other .I Paper Pelued Stenci itd


### Section

- IV

1. Contact Point (Complflte ;roms directly b%w fOf identification of indfvfdUfll to b. contflc(tld, if nocossary, to process this 1IPP1,ct;'ian.)

Name Title 

## 'I Teiophone No. '{include Area Codel

Morris Gaskins Registrations Manager 

# i 229-244-3281} t
._

;----,--- 

# '-.

Certification 

### , 6. Dete Applicetion

I certify thet the statements I he

... e mrnla on this form and ell ettochments thuroto are trua, eccurute and cO":!plotii. RacI!i

... t'}:I

lucknowledge that any knowlinglly false or misleading stetement may ba punishable by IIna or imprisOM'lent c-: ($tampedl both under applicable lew. 

### , '.



### ,

2. 

# Si,""",, 

# 0

"'-Y 

# /J--/l-j, 3. Title >')

,



### , Regislrations Manager , 

### '"



### , ,

4. Typed Nama 

### I 5. Oat.

Mmris Gaskins 

### June 23, 2011

.. EPA Form 8570·1 (R

..... 3-94) PrevIOus editIOns Ilra obselate • 

## . Whit.

- EPA File Copy {onginlll V.llow· Applicant CopyCORPORATE OFFICE

1525 NE 36th Street
Ankeny. IA 5002 t

515.964.9444 (Phone)

800.247.8013 (Toll Free)

515.964.7813 (FAX)

# A~BAUGH, 

# H\.C.

June 23, 2011

Document Processing Desk (AMEND)

Ms. Shaja Joyner (Team 20) Registration Division
Office of Pesticide Programs (7504P)
U.S. Environmental Protection Agency

Room S-4900, One Potomac Yard (South Bldg)

2777 South Crystal Dr. Arlington, VA 22202

RE: Propiconazole Technical

EPA Reg. No. 42750-221

Dear Ms. Joyner, Fed-X GEORGIA OFFICE

P.O. 80x 2127
Valdosta, GA 31604_2t27

229.244.3288 (Phone)

229.244.5841 (FAX)

The enclosed submission for the 

### above referenced registration is a proposed amendment to add an alternate manufacturing source. Documents in support of this submission are detailed on the attached transmittal

page.

Albaugh believes this submission qualifies as a PRIA R340 action with $3,617 fee and 4 month review time.

Please call if you have any questions.

Regards,

Morris Gaskins Registrations Manager Albaugh, Inc.

229-244-3288



# Agri

# ~f!!.,:o.
PREMIER SUPPLIER OF OFF-PATENT CROP PROTECTION PRODUCTS www.albaughinc.com

## TRANSMITTAL DOCUMENT

Name and address of submitter:

Albaugh, Inc. P.O. Box 2127 Valdosta, GA 31604-2127

Company Official: Morris Gaskins



### Telephone: (229) 244-3288

Regulatory action for which this package is submitted:

Altemate manufacturing source for PROPICONAZOLE TECHNICAL

Transmittal Date: June 23, 2011

List of items submitted:

• Transmittal page

• Cover letter



### • 8570-1 application form

• 8570-34 Certification With Respect to Citation of Data form

• 8570-35 Data Matrix (internal use copy)



### • 8570-35 Data Matrix (public file copy)

• Altemate CSF 

### # 1 (2 copies)

• PRIA fee check copy 

### & form

• Series 830-A Product Identity and Composition, Description of Materials Used to Produce the Product, Description of Formulation Process, Discussion of Formation of Impurities, Certified 

### Limits, and Enforcement Analytical Method (OPPTS Guidelines 830.1550, 830.1600, 830.1620,830.1670, and 830.1750) (3 copies)

• Series 830-A Preliminary Analysis and Enforcement Analytical Methods (OPPTS Guidelines


### 830.1700 and 830.1800) (3 copies)Form Aooroved OMB No, 2070...(1060



# ... UNITED STATES ENVIRONMENTAL PROTECTION AGENCY



## - 

# ""

,**\~'** 401 M Street, S.W.

-";I WASHINGTON, D,C, 20460

PapolWork Roductlon Act Notico: The public reporting burden for this collection of information is eslimated to average 1.25 hours per response for registration

and 0.25 hours per response for reregistration and special review**activ~ies,** including time for reading the instructions and completing the necessary forms, Send
commenls regarding burden estimate or any other aspect of this collection of information, induding suggestions for reducing the burden to: Director, OPPE

Informalion Management Oivision (2137), U.S. Environmental Protection Agency. 401 M Sireet, S.W., Washinglon, OC 20460,
00 nol send Ihe completed form to this address.

Certification with Respect to Citation of Data

Applicant's/Registrant's Name, Address, and Telephone Number EPA Registraiion Number/File Symbol Albaugh, Inc. P.O. Box 2127 Valdosta, GA 31604 42750·221

Active Inqredient(s) and/or representative test compound(s) Dat,
Propiconazole 6/2312011

General Use Pattem(s) (list all those claimed for this product usinQ 40 CFR Part 158) Product Name

MUP for terrestrial food use, terrestrial non·food use Propiconazole Technical

NOTE: If your product is a 100% repackaging of another purchased EPA·registered product labeled for all the same uses on your label, you do not need to
submit this form. You must submit the Formulator's Exemption statement (EPA Form 8570-27). 

# 0 I am responding to a Oata-Call-In Notice, and have included with this form a list of companies sent offers of compensation (the Data Matrix form Should
be used for this purpose).

SECTION I: METHOD OF OATA SUPPORT {Check one melhod only) 

# 0 I am using the**c~e-all** method of support, and have inCluded with this form 

# [2] I am using the selective method of support (or cite-all option

a list of companies sent offers of compensalion (the Oata Matrix form under the selective method), and have included with this form a Should be used for Ihis purpose), completed list of data requirements (the Oata Matrix form must be used),

SECTION II:**GE~ERAL** OFFER TO PAY

[Required if using the cile-all method or when using the cite-all oplion under the selective method to satisfy one or more dala requirementsl 

# [2] I hereby offer and agree to pay compensation, to other persons, with regard to Ihe approval of this application, to the extenl required by FIFRA

SECTION III: CERTIFICATION

I certify that th'l$ application for registratlon, th'ls form for reregislration, or this Oata-Call-In response is supported by all data submitted or cited in the application for registration, the form for reregistration, or the Data-Call-In response. In**add~ion,** if the cite-all option or cite-all option under the selective method is
indicated in Section I, thiS application is supported by all data in the Agency's/lles that (f) concern the properties or effects of this product or an identical or substantially Similar product, or one or more of Ihe ingredients in this product; and {2) is a type of data that woutd be required to be submitted under the dala requirements in effecl on the date of approval of this application if the application sought the initiat registration of a product of idenUcal or simila5**~('JllPosition** and

uses.



# -

- '-'



## - n



### , I certify that for each exclUSive use stUdy cited in support of this registration or reregistration, that I am the original**~ata** suiJmitter or thaf'l have obtained
the written permiSSion of the original data Submitter to cile that study, 

### "



# - , 

## ,

, 

## - , I certify that for each stUdy**c~ed** in support of this registration or reregistraUon that is not an exclusive use study,**e~her;** (a)-I am**th~** llriginaidjata submitter; {b) I have obtained the permission of the original data SUbmitter to use the study in support of this applicaUon; {c) all feriOdS of eligibility lor; compensation have expired for the study; (d) the study is in the public literature; or (e) I have notified in writing the company tha sui5mitted the study and have

offered (I) to pay compensation to the extent required by sections 3(c)(1)(F) and/or 3(c)(2){8) of FIFRA; and (ii) to commence**ne9o~alions** to deterfiline the

amount and terms of compensation, if any, to be paid for the use of the study. > ••**~** ;



### , I certtfy that in all instances where an offer of compensation is required, copies of all offers to pay compensation and evidence of thp,ir deli'tery in

accordance wilh sections 3{c)(1)(F) and/or 3(c)(2)(B) of FIFRA are available and will be**subm~ted** to the Agency upon request. Should I fail til ptotioce such
evidence to Ihe Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registration of my product in**conform~y** with
FIFRA.

t cortify1hat the statements I havo made on this form and all altachments to it are 1rue, accurate, and complote. I acknowledge that any knowingly false or misleading sla1ement may be punishable by ftne or imprisonment or both undor applicable law.

Signa lure

# ~,-q,/)-§. Date Typed or Prinled Name and Title

6/2312011 Morris Gaskins Registrations Manager

EPA Form 8570-34 19-97)**Ele~nic** and Paper versions available. Submit only Paper version.FormApprovedOMBNo.UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,DC20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationact'lvitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforredudngtheburdento:Director,OPPEInformationManagementDivision(2137)u.s.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460,Donotsendtheformtothisaddress.DATAMATRIXDate:6/23/2011EPAReg.No./FileSymbol42750-221Page1of8Applicant's/Registrant'sName&Address:AlbaughInc.Product1525NE5t.PROPICONAZOlETECHNICALAnkeny,IA50021Ingredient:PropiconazoleCAS#60207-9D-lGuidelineReferenceGuidelinestudyNameMRIDNumberSubmitterStatusNote830.1550ProductIdentityandCompositionWithapplicationAlbaughOWN830.1600DescriptionofMaterialsusedtoProducetheWithapplicationAlbaughOWN830.1620DescriptionofProductionProcessWithapplicationAlbaughOWN830.1650DescriptionofFormulationProcessWaiver830.1670Des.criptionofFormationofImpuritiesWithapplicationAlbaughOWN830.1700PreliminaryAnalysisWithapplicationAlbaughOWN830.1750CertifiedLimitsWithapplicationAlbaughOWN830.1800EnforcementAnalyticalMethodWithapplicationAlbaughOWN830.6302Color482585-04AlbaughOWN830.6303PhysicalState482585-04AlbaughOWN830.6304Odor482585-04AlbaughOWN830.6313StabilitytoNormalandElevatedTemperatures,482585-04AlbaughOWNMetalsandMetalIons830.6314Oxidation/Reduction:ChemiC?l1Notreq'd1830.6315Flammability...·","Notreq'd1...·.830.6316NotreqW830.6317StorageStability"w.482585-04AlbaughOWN.,. .-.Signature•·..NameandTitle:MorrisGaskinsDate:A.:/)._.;--4'.-';)-0:?'-.RegistrationsManager6/23/2011.-n.r-____....,....,1'>.., ...,.........."....__,___...In____..____.._"_L'_.....1-..,..__,••_____••___,__..____•____'••__r__..FormApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECfIONAGENCY401MStreet,S.W.WASHINGTON,DC20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137)U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDate:6/23/2011EPAReg.No./FileSymbol42750-221Page2of8Applicant's/Registrant'sName&Address:AlbaughInc.Product:1525NE36fuSt.PROPICONAZOlETECHNICALAnkeny,IA50021Ingredient:PropiconazoleeftS#60207-90-1GuidelineReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStatusNote830.6319MiscibilityNotreq'd830.6320CorrosionCharacteristics482585-04AlbaughOWN830.6321DielectriCBreakdownVoltageNotreq'd830.7000pH482585-04AlbaughOWN830.7050UV/VisibleAbsorption482585-{)4AlbaughOWN830.7100Viscosity482585-{)4AlbaughOWN830.7200MeltingPoint/MeltingRangeWaiver'830.7220BoilingPoint/BoilingRange482585-04AlbaughOWN830.7300Density/RelativeDenSity/BulkDensity482585-04AlbaughOWN830.7370DissociationConstantsinWaterNotreqW830.7550PartitionCoefficient(n-octanol/water),Shake482585-04AlbaughOWNflaskMethod830.7560PartitionCoefficient(n-octanol/water),Waiver4GeneratorColumnMethod830.7570PartitionCoefficient:(n-0ctandl/watEr),Waiver4EstimationbyLiquid'tnrmnatogrdphywSignature..NameandTitle:MorrisGaskinsDate:...RegistrationsManager6/23/2011'-...A...____.-.r..,,,-.....,n.-."'7'1.-,_.....___'___....n____.___,_...__.._.,,__.....0..."'"__I..""'____••___,__A_________III__f'__..."FormApprovedOMSNo.UNrrEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,DC20460PaperworkReductionAct.Notice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponsefOrreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137)U.s.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDate:6/23/2011EPAReg.No./FileSymbol42750·221IPage30f8Applicant's/Registrant'sName&.Address:AlbaughInc.Product:1525NE36-5t.PROPICONAZOLETECHNICALAnkeny,IA50021Ingredient:PropiconazoleCAS#60207-90-1GuidelineReferenceNumberGuidelineStudyNameMRlDNumberSubmitterStatusNote830.7840WaterSolubility:ColumnElutionMethod;482585·04AlbaughOWNShakeFlaskMethod830,7860WaterSolubility,GeneratorColumnMethodWaiver830,7950VaporPressure482585-04AlbaughOWN870,1100AcuteOralToxicity-RatCITEAllPAY870,1200AcuteDermalToxicity-RatOTEAllPAY870,1300AcuteInhalationToxiCityRatOTEALLPAY870.2400PrimaryEyeIrritationRabbitCmAllPAY870.2500PrimaryDermalIrritationcmAllPAY870,2600DermalSensitizationCITEAllPAY-""'-"","-."""'"-,,"",,,'"SignatureNameandTitle:MorrisGaskinsDate::;/:"RegIstrationsManager6/23/2011[OnAoO:::'fl..':>o:'Inn,'t:ln..............,,_.............II...FormApprovedOMBNo.UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,DC20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137)U.s.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDate:6/23/2011EPAReg.No./FileSymbol42750-221Page4of8Applicant's/Registrant'sNameStAddress:AlbaughInc.Product:1525NE36'h5t.PROPICONAZOLETECHNICALAnkenv.1A50021Ingredient:PropiconazoleCAS#GuidelineReferenceNumberTGuidelinestudyNameTMRIDISubmitter(EPACo.No.)StatusNoteAlbaughwillmaketothefollowingcompaniesthatappearonthecurrentdatasubmitterslistforpropiconazole.PropiconazoleGenericDataate-AllSyngenta(lOO)PAYPropiconazoleGenericDataCite-AllBayerCropscience(264)PAYPropiconazoleGenericData.DuPont(352)PAYPropiconazoleGenericDataCite-AllIBCManf.(1022)PAYPropiconazoleGenericDataCite-AllOsmose(3008)PAYPropiconazoleGenericDataCite-AllBayerCorp(3125)PAYPropiconazoleGenericDataCite-AllTroyChemical(5383)PAYPropiconazoleGenericDataCite-AllBASF(7969)PAYPropiconazoleGenericDataAndersons(9198)PAYPropiconazoleGenericDataCite-AllMakhteshim(11678)PAYPropiconazoleGenericDataLovelandProducts(34704)PAYPropiconazoleGenericDataate-AllNufanmLimited(35935)PAY--Janssen(43813)PropiconazoleGenericDataCite-All--•.-PAYo "__.---PropiconazoleGenericDataCite-All.- -.·BA5FSparks(5lO36)PAY--PropiconazoleGenericDataCite-AllControlSolutions(53883)PAYPropiconazoleGenericDataCite-All-..Contechem(57227)PAY.....·-•---·.---'.-...•_.,---Signaturea'-.:NameandTitle:MorrisGaskinsDate:RegistrationsManager6/23/2011_.EPAForm8570-35ElectronicandPaperversionsavai,'Submitonlypaperversio,'.A____•___,gencylalUseCopyFormApprovedOMSNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,DC20460PaperworkReductionActNotice:ThepUblicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137)US.EnvironmentalProtectionAgency,401MStreet,SW.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDate:6/23/2011EPAReg.No./FileSymbol42750-221IPage50f8Applicant'S/Registrant'sName&Address:AlbaughInc.Product:1525NE36·5t.PROPICONAZOLETECHNICALAnkenIA50021Ingredient:PropiconazoleCAS#60207-90-1GuidelineReferenceNumberGuidelinestudyNameMRIOSubmitter(EPACo.No.)statusNotePropiconazdeGenelicDataCite-AllKop-Coat(60061)PAYPropiconazoleGenericDataCite-All5ipcamAgro(60063)PAYPropiconazoleGenericDataate-AllTessenderloKerley(61842)PAYPropiconazoleGenelicData'Cite-AllArchWoodProtection(62190)PAYPropiconazoleGenelicDataCite-AllDow(62719)PAYPropiconazoleGenericDataCite-AllMANA(66222)PAYPropiconazoleGeneriCDataCite-AllArystaUfeScience(66330)PAYPropiconazoleGenericDataCite-AllSprayDriftTaskForce(66607)PAYPropiconazoleGenelicDataCite-AllRepar(69361)PAYPropiconazoleGenericDataate-AllDiaconTechnologies(70227)PAYPropiconazoleGenericDataCite-AllDr.WolmanGMBH(71406)PAYPropiconazoleGenericDataCite-All15KB"ocides(71581)PAY,,,,PropiconazoleGenericDataCite-All•· ··Nichino(71711)PAY...···.-.--PropiconazoleGenericDataCite-All··-·GRETF(71754)PAY..PropiconazoleGenericDataCite-AllAgRe-EntryTF(71755)PAYw.... .· ..-.-·.--.-..--Signature...,·..NameandTitle:MorrisGaskinsDate:'fi;;;-·../2--v"-",RegistrationsManager6/23/2011[On.-[0_<,>[0..,,,."".'1"0"..""',_.....___:___..In____..___.._:1...,_co.....__,.._____..___:__A____•T_.....___, , ,__r__..FormApprovedOMSNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,DC20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistratiOllactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,indudingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregard'lngtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,QPPEInformationManagementDivision(2137)U.S,EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460,Donotsendtheformtothisaddress.DATAMATRIXDate:6/23/2011EPAReg.No./FileSymbol42750-221]Page6of8Applicant's/Registrant'sName&.Address:AlbaughInc.Product:1525NE36"St.PROPICONAZOLETECHNICALAnkenv.IA50021Ingredient:PropiconazoleCA5#60207-90-1GuidelineReferenceNumberGuidelineStudyNameMRIDSubmitter{EPACo.No.}StatusNote-PropiconazoleGenericDataate-AllBayerAdvanced(72155)PAYPropiconazoleGenericDataCite-AllZelam(72616)PAYPropiconazoleGenericDataCite-AllSapstainInd.Group(73154)PAYPropiconazoleGenericDataCite-AllEndangeredSpecies1F(73989)PAYPropiconazoleGenericDataCite-AllIrvitaPlantProtection(74054)PAYPropiconazoleGenericDataCite-AllOsmoseNewZealand(74405)PAYPropiconazoleGenericDataCite-AllResidentialExposureTF(74888)PAYPropiconazoleGenericDataCite-AllSupremeChemicals(75082)PAYPropiconazoleGenericDataCite-AllArchWoodProtection(75101)PAYPropiconazoleGenericDataCite-AllAgHandlersTF(75234)PAYPropiconazoleGenericDataCite-AllArchTreatment(75506)PAYPropiconazoleGenericDataCite-AllUSTriazoleTF(75576)PAYPropiconazoleGenericDataCite-AllGro-Pro(79676)PAY-w _PropiconazoleGenericDataCite-All.--.PhoenixEnvironmental(81943)PAYo "v----·...PropiconazoleGenericDataCite-All---·..Etigra(81959)PAY--.-.-·.---•·.·. .·-•-..SignatureNameandTitle:MorrisGaskinsDate:RegistrationsManager6/23/2011I:OnAn""r.'31:."'nn"'"1:01_............_:___.-In___,._____,._,,_1_l'••t.:__I,._____,._,__(9-97)p'Iypap'A____•____'11__r"__".gencypyFormApprovedOMBNo.UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,DC20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand025hoursperresponseforreregistrationandspecialreviewactivities,indudingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofth'lscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137)U.s.EnvironmentalProtecflonAgency,401MStreet,.S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDate:6/23/2011EPAReg.No./FileSymbol42750-221Page7of8Appllcant's/Registrant'sName&Address:AlbaughInc.Product:1525NE36"St.PROPICONAZOLETECHNICALAnkenY.IA50021Ingredient:PropiconazoleCAS#GuidelineReferenceNumberGuidelineStudyNameMRIDSubmitter(EPACo.No.)StatusNotePropiconazoleGenericDataShardaUSALLC(83529)PAYPropiconazoleGenericDataAmtide(83851)PAYPropiconazoleGenericDataate-AllGESTF(84653)PAYPropiconazoleGenericDataCite-All..BerkemDevelop(86505)PAYPropiconazoleGenericDataCite-AllWillowoodPropiconazole,LLCPAYPropiconazoleGenericDataGte-Ali.WillowoodUSA,LLCPAY.-.···...·::::..v".·•.-·.··.··••......--·-..·•·..•.,iSignatureM,.,../'J/-NameandTitle:MorrisGaskinsDate:RegistrationsManager6/23/2011-_____n_'_...",.-,.,...--".-Footnote1FootnotesforPROPICONAZOLETECHNICALDataMatrixPage8of8-830.6314Oxidation/Reduction:chemicalincompatibility830.6315Flammability-830.6316Explodability-830.6319Miscibility-830.6321DielectricBreakdown-830.7370DissociationsConstantThisdataisnotrequiredforTechnicalGradeorMUPproductsperProductPropertiesTestGuidelinesOPPTS830.1000(e)(2)(xi)(B)Table2Footnote2-830.1650FormulationProcess.Albaughrequestsawaiverforthisdatarequirement.PROPICONAZOLETECHNICALproductisnotdeliberatelyformulated.SeeGuidf'830.1620Footnote3-830.7200MeltingPoint.Albaughrequestsawaiverforthisdatarequirement.PROPICONAZOlETECHNICALproductisnotasolidproduct.Footnote4-830.7560PartitionCoefficient,'GeneratorColumnMethod-830.7570PartitionCoefficient,UquidChromatographyMethodAlbaughrequestsawaiverforthesedatareqUirements.AlbaughelectedtouseGuideline830.7550tosatisfythisdatarequirement.Footnote5830.7860WaterSolubility,GeneratorColumnMethod.Albaughrequestsawaiverforthisdatarequirement.AlbaughelectedtouseGuideline830.7840tosatisfythisdatarequirement."W"","""""

# Material to**l.~** 

# added to an e-Jacket/Jacket

Description: 

# 'V\Dc1ucl-**f:g0,(C~\\(tj\ ;61~'** 

.' 

## " .-,



# 1.**~lacement** 

# within the e-Jacket/jacket:

c9f----Qefault: (chronological, top 

# = newest)

o File 

# location: (PDF page number, i.e., "before page 

# 45")**~end** 

# to Data Extraction contractors this material:

# {B~ Newly stamped accepted label

o Notification 

# ):l NewCSF

o Other:

3. Attach this coversheet to the top of the material or jacket. It
must be well organized and clipped together, NOT STAPLED.
Then give the material with this coversheet to staff in the
Information Services Center (Room S-4900).



# Reviewer's Name:**~~o;::"="** c...' 

### \\.u\j.J-'I",,\

_________ _



# Ph 0 

# n e: -.:,,' '<,;:.l\,,-"'L.! 

## '-,,9-,"*2\ l..c"...!.\

____ 

# Divis i on: --"Yc!..··1""",-'''--

__ _



# Date:

Created August 19,2008U.s. ENVIRONMENTALPROTECTlON AGENCY EPA Reg. Number:

Office of Pesticide Programs Registration Division (7505P) 

### 42750-221

1200 Pennsylvania Ave., N.W.

Washington, D.C. 20460



### NOTICE OF PESTICIDE: 

## -.-K. Registration

_ Reregistration

(under FIFRA. as amended)

Name and Address ofRegistranl (include ZIP Code): 

### Morris Gaskins 

## Albaugh, INC
P.O. Box2l27 Valdosta, GA 31604 Term of Issuance: 

### Conditional

Name of Pesticide Product: 

### Propiconazole Technical Dale oflssuance:



### On the basis of infonnation furnished by the registrant, the above named pesticide is hereby registered
under the Federal Insecticide, Fungicide and Rodenticide Act. Registration is 

### in no way to be construed

as an endorsement or recommendation of this product by the Agency. In order to protect health and the environment, the Administrator, on his motion, may at any time suspend or cancel th'e 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 conditionally registered in accordance with FIFRA section 3(c)(7)(A) provided that you: 1) Submit and/or cite all data required for registration of your product under FIFRA section 3{ c)(5)
when the Agency requires all registrants of similar products to submit such data; and submit acceptable responses required for reregistration of your product under FIFRA section 4.

2) You must submit two copies ofa final printed label within 30 days from the date ofthis notice

which makes the following changes:

......................................................................................................................................... Continued

Signature of Approving Official:


# lJ**#(~ sr;a~t:er,**  Product Manager (20) Fungicide Branch, Registration Division (7504P)

EPA Form 857()-6 Date:

### ~ 

# 2D111

### Page 2 of2 EPA Reg. No. 42750-221

3) You must submit the following conditional data before the due date of 

### 5/23/2012.

• OxidationIReduction Chemical Incompatibility (830.8314)

• Explodability (830.6316).
The results must be submitted to the Agency in electronic and hard copy formats.

4) On page 1:

• Change the EPA registration number to 42750-22l.

• Change the signal word to "Warning".

• Reorder the First aid statements as follows

1. If Swallowed

2. If on Skin or Clothing

3. Ifin Eyes

4. IfInbaled

5) On page 2:

• Change the signal word to "Warning".

• Revise the Hazards 

### to Human and Domestic Animals section so that it reads as follows: "May be fatal 

### if swallowed. Harmful if absorbed through skin. Causes moderate eye irritation. Avoid contact with 

## skin, eyes or clothing. Wash thoroughly with soap and

water after handling and before eating, drinking, chewing tobacco or using the toilet.

Wear 10ngMsleeved shirt and long pants, socks, and gloves. Remove and wash

contaminated clothing before reuse. Wear protective eyewear. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals."

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.

A stamped copy of the label stamped "Accepted with Comments" is enclosed for your records. If you have any questions, please contact Shaunta Hill at 703 M 3437-8961 or by email at hill.shaunta@epa.gov

or myself at 703 M 308 M 3194 or joyner.shaja@epa.gov.

Shaja 

### B. Joyner**Product~anager(20)** 

### Fungicide Branch Registration Division (7504P)

### PROPICONAZOLE TECHNICAL 

### For Formulation of Fungicides

ACTIVE INGREDIENT: Propiconazole (CAS No. 60207-90-1)

................................. 96.5%
OTHER INGREDIENTS:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 3.5%
TOTAL:

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

KEEP OUT OF REACH OF CHILDREN.

CAUTION

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 poison control center or doctor for treatment advice.

IF ON SKIN OR 

# • Take off contaminated clothing. CLOTHING 

# • Rinse skin immediately with plenty of water for 1 5-20 minutes.



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

IF 

# • Call poison control center or doctor immediately for treatment advice.
SWALLOWED 

# • Have person sip a glass of water 

### if able 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 person. IF INHALED 

# • Move person to fresh air.



# • If person is not breathing, call 91 1 or an ambulance, then give artificial respiration, preferably by mouth-to-mouth, if possible.



# • Call a poison control center or doctor for treatment advice.
Note to Physician: There is no specific antidote for Propiconazole Technical. Induce emesis

or lavage stomach. Give a saline laxative and supportive therapy.
Have the product container or label with you when calling a poison control center or doctor, or 

# I going for treatment.

HOT LINE NUMBER

- In the event of a major spill or accident, call CHEMTREC at 1-800-424-
9300 day or night.

EPA Reg. No. 42750-appl.

NET CONTENTS:

MANUFACTURED FOR: 

### EPA Est. No. xxxxxx-xxx-xxx



### , ,



### , ,."


### , ,

, '"



### ,

'"

) 

### "'"



### , , 

# ., ACCEPTED with 

## COMMENTS
In EPA Letter Doted Albaugh, Inc. AnkenY,IA 50021 ) 

### , ,

## ~y;03J~'11 Under !he F&IeraJ**"~clde,** 

### Fungicide, and RodenticideAct,.

as amended, for the pesticide

## reg~%'!J§PA?~'IYO' " " 

### , "



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### 1

### PRECAUTIONARY STATEMENTS
Hazards to Humans and Domestic Animals

CAUTION

Causes moderate eye irritation. Avoid contact with eyes or clothing. Harmful 

### if swallowed, inhaled, or absorbed through the skin. Prolonged or frequently repeated skin contact may cause allergic reaction in some individuals. Wash thoroughly with soap and water after handling and
before eating, drinking, chewing gum, or using tobacco.

ENVIRONMENTAL HAZARDS

This product is toxic to fish. Do not apply directly to water, to areas where surface water is present, or to intertidal areas below the mean high water mark. Do not contaminate water 

## by cleaning of equipment or disposal of wastes. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or other 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 EPA.

DIRECTIONS FOR USE

It is a violation of federal law to use this product in a manner inconsistent with its labeling.

Only for formulation into fungicides for the following uses:

(1) Preservation of wood, leather, paint & 

### coatings, caulk, adhesives, metal working fluids and pulp and paper;

(2) almonds

banana and plantains
berries crop group carrots celery and leaf petioles subgroup
cereals (wheat, barley,

rye, triticale and oats)
cilantro
citrus (non-bearing)

corn (field, seed, popcorn and sweet corn)

cranberries
filberts

grasses grown for seed
mint
onions (dry bulb and green onion) parsley peanuts

pecans pineapples pineapple (post harvest) pistachios rice, wild rice sorghum soybeans

stone fruit
strawberries

sugar beets

sugarcane tree nuts
turf and ornamentals;

(3) uses for which USEPA has accepted the required data and/or citations of data that 

## 'itl€' : , formulator has submitted in support of registration; and , , "

)" ) 

### (4) uses for experimental purposes that are in compliance with USEPA.

Albaugh, Inc. recommends this product only for the uses cited above and makes no**war~anty,** 

### expressed or implied, with respect to formulator supported uses or experimental uses 

### and, >' 

### disclaims all liability for damages attributable to such formulator supported and experimental

uses. ",.:,

", 

### , ,"



### , 

### 2 , , , • > ,



### , ,

,
, , > , , ,

, >

### NOTE TO FORMULATORS

- Formulators are responsible for providing data to support registration of 

### products formulated from Propiconazole Technical.

STORAGE AND DISPOSAL

Do not contaminate water, food, or feed 

### by storage or disposal.

PESTICIDE STORAGE: Store in a cool, dry, well-ventilated area.

PESTICIDE DISPOSAL: Pesticide wastes may be acutely hazardous. Improper disposal is a violation 

### of federal law. Pesticide, mhctures, or equipment rinse water that cannot be chemically reprocessed must be disposed of according to applicable federal, state, or local procedures.
Contact your State Pesticide or Environmental Control Agency or the Hazardous Waste representative at the nearest EPA Regional Office for guidance.

CONTAINER DISPOSAL: Non-refillable container. Do not reuse or refill this container. Triple
rinse promptly after emptying.

Triple rinse as follows: Empty the remaining contents into application equipment or a mix tank.

Fill the container Y4 full with water. Replace or tighten closures. Tip containewr4 on its side and
roll it back and forth, ensuring at least one complete revolution. Stand the container on its end
and tip back and forth several times. Turn the container over onto its other end and tip it back
and forth several times. Empty the rinsate into application equipment or a tank mix or store
rinsate for later use or disposal. Repeat this procedure two more times. Return to manufacturer, or offer for recycling or reconditioning, or dispose of in a sanitary landfill, or by
other state and local approved procedures.

CONTAINER IS NOT SAFE FOR FOOD, FEED, OR DRINKING WATER.

CONDITIONS OF SALE AND LIMITATION OF WARRANTY AND LIABILITY

NOTICE: Read the entire Directions for Use and Conditions of Sale and Limitation of Warranty
and Liability before buying or using this product. If the terms are not acceptable, return the product at once, unopened, and the purchase price will be refunded.

The Directions for Use of this product must be followed carefully. It is impossible to elim'lnate all
risks inherently associated with the use of this product. Crop injury, ineffectiveness or other
unintended consequences may result because of such factors as manner of use or application,
weather or crop conditions, presence of other materials or other influencing factors in the**u~.e** 

### of
the product, which are beyond the control of Albaugh, Inc. or Seller. To the extent const5tenl'
with applicable law, Buyer and User agree to hold Albaugh, Inc. and Seller harmless for any, claims relating to such factors. ' , , ,

Albaugh, Inc. warrants that this product conforms to the chemical description on the lab.i:A'dlIU is reasonably fit for the purposes stated in the Directions for Use, subject to the inherent rifJ<s

, referred to above, when used in accordance with directions under normal use conditions. This warranty does not extend to the use of the product contrary to label instructions, or under '



# . , "


### , , "



### , , "



### , 3 

### , , , , , ,

, "



### , ,

, , > , , ,



### , ,

, 

### ,

### conditions not reasonably foreseeable to or beyond the control of Seller or Albaugh, Inc., and to
the extent consistent with applicable law Buyer and User assume the risk of any such use.

ALBAUGH, INC. MAKES NO WARRANTIES OF MERCHANTABILITY OR OF FITNESS FOR A
PARTICULAR PURPOSE NOR ANY OTHER EXPRESS OR IMPLIED WARRANTY EXCEPT
AS WARRANTED BY THIS LABEL.



### To the extent consistent with applicable law, neither Albaugh, Inc. or Seller shall be liable for

any incidental, consequential or special damages resulting from the use or handling of this 

### product.

TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, THE EXCLUSIVE REMEDY OF

THE USER OR BUYER, AND THE EXCLUSIVE LIABILITY OF ALBAUGH, INC. AND SELLER
FOR ANY AND ALL CLAIMS, LOSSES, INJURIES OR DAMAGES (INCLUDING CLAIMS
BASED ON BREACH OF WARRANTY, CONTRACT, NEGLIGENCE, TORT, STRICT
LIABILITY OR OTHERWISE) RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT, SHALL BE THE RETURN OF THE PURCHASE PRICE OF THE PRODUCT OR,
AT THE ELECTION OF ALBAUGH, INC. OR SELLER, THE REPLACEMENT OF THE
PRODUCT.



### Albaugh, Inc. and Seller offer this product, and Buyer and User accept it, subject to the foregoing Conditions of Sale and Limitation of Warranty and Liability, which may not be modified except by written agreement signed by a duly authorized representative of Albaugh, Inc

..



# . 

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### • • • • "

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### , 4 

# . . "DATE OUT:

SUBJECT:

FROM:

TO: 

### 181 APRIL! 2011

PRODUCT CHEMISTRY REVIEW OF MP 

### [X 

## 1 EP [ 

## 1

DP BARCODE No.: 0383714 EPA File Symbol No.: 42750-EER
PRODUCT NAME: Propiconazole Technical


### COMPANY: Albaugh Inc.
FOOD USE 

### [X 

## 1 INTEGRATED FORMULATION 

### [X 

## 1 

# pee: 122101 Decision No. 440858
ACTION CODE: R310

Hari Mukhoty, DVM, PhD

Product Chemistry Team

Technical Review Branch 

### I RD (7505P)

Shaunta Hill 

### I Shaja Joyner, RM 20 Fungicide Branch 

### I RD (7505P)

INTRODUCTION:

The Registrant has submitted a basic CSF (dated: 10108/2010) for a proposed TGAIIMUP, and has also proposed a product specific label for registration of the aforesaid product under EPA File symbol 42750-EER.
The product chemistry data have been submitted under MR1Ds: 482585-01 through -05.

The aforesaid MUP is manufactured by for Albaugh, Inc. in
USA.

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 substantfally similar to another registered product EPA Reg.
No. 83633-13 (Product name: Sharda Propiconazole Technical). The cited product was conditionally registered

on 

### 07/31/2009. The product chemistry data for the cited product were reviewed and were found 

### to be acceptable on 

### 07/16/2009. The product specific label was accepted on April 19, 2010.

TRB has been requested to evaluate the product chemistry data required for the registration of the proposed

MUP and to determine if the proposed prOduct is substantially similar to the cited product.



### SUMMARY OF FINDINGS:

1. The proposed TGAI/MUP contains the active ingredient: Propiconazole (96.5%).

2. The overall mean of the active ingredient from the five batch analysis is 96.50% [MRID: 482585-03, Page 11J.

3. The proposed nominal concentration of the active ingredient in the MUP is 96.5%. The nominal

concentration of the active ingredient matches with the label claim. This is in compliance with PR Notice 91-2.

The registrant proposed wider certified limits for the active and inert ingredients which comply with 40 CFR 

### §
158.175 (c) (1). However, the registrant did not offer any justification of their choice.

4. The CSF of the proposed TGA1/MUP is filled out completely and correctly. This CSF has been reviewed by


### I.IA Branch and they have concluded that it contains active ingredient and impurities only.

1

### DP BARCODE No.: 383714 EPA File Symbol No.: 42750-EER PRODUCT NAME: Propiconazole
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 of formation of impurities), 830.1750 (certified limits) satisfy the product chemistry data requirements of 40 CFR §158.320, 158.325, 158.330, 158.340, and 158.350 respectively for the proposed formulation [MRID: 482585-02[.

6. The active ingredient and the associated impurities were quantified by HPLC method using UV detector set at
220 nm and were also identified by GC/MS. The
method validation was achieved by generating specificity, accuracy, linearity and precision data under the specified analytical conditions [MRID: 482585-03].

Similar analytical techniques can also be applied for Enforcement Analytical Method.



### 7. Product chemistry Group A and Group B data, with the exception of Oxidation/Reduction, Chemical Incompatibility (830.83140) and Explodability (830.6316) requirements are satisfied [MRIDs: 482585-01 through 

### -04].

8. The registrant did not comment regarding the toxicological significance of the associated impurities present
in the proposed TGAI/MUP.

9. The proposed product is substantially similar to the cited product because the nominal concentration of the
active ingredient of the proposed product (96.5%) falls within the certified limits of the cited product (98.23%

- 92.51 %) and the proposed product has less numberof impurities compared to the cited product.

CONCLUSIONS:

1. TRB has reviewed the CSF for the proposed T<3AI/MUP and has found it to be acceptable.

2. The proposed TGAI/MUP is substantially similar to the cited product.

3. Product chemistry data requirements for Group A and Group B, with the exception of Oxidation/Reduction,
Chemical Incompatibility (830.83140) and Explodability (830.6316) are satisfied and acceptable.

4. The proposed label was screened as it pertains to the product chemistry requirements. The final review of
the proposed label and uses are the purview of the PM team.

2DP BARCODE No.: 383714 EPA File Symbol No.: 42750

w EER PRODUCT NAME: Propiconazo!e
Technica!

PRODUCT CHEMISTRY DATA (SERIES 830 Group A)

Group A Data Required MRID No.
Fulfilled

830.1550. Chemica! Identity (same as in Product CSF A 482585-02


### dated 11/23/2009)

830.1600. Beginning Materia!s A "

830.1620. Production process A "

830.1650. Formu!ation process NA

830.1670. Discussion of Impurities A "

830.1700. Preliminary Analysis A 482585-03

830.1750. Certified Limits A 482585-02

. 830.1800. Enforcement Analytica! Method A 485585-03

A 

# = Acceptable NA 

# = Not Applicable

3

### DP BARCODE No.: 383714 

### EPA File Symbol No.: 42750-EER 

### PRODUCT NAME: Propiconazole

Technical

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

### Q
Fulfilled

830.6302. Color A Yellowish to 482585-04

Brownish

830.6303. Physical State A Viscous liquid "



### 830.6304. Odor A Odorless "



### 830.6313. Stability to normal and elevated A Stable when 

### 482585-01 temp, metals and metal ions exposed to normal
& elevated temp
and metals & metal

ions

830-6314. Oxidation/Reduction action- 

# ,G "
Chemical incompatibility



### 830.6315. FlammabHlty 

### A Not Flammable, "

212°F



### 830.6316. Explodability 

### G "



### 830.6317. Storage stability 'A Stable 

### 482585-05

830.6319. Miscibility NA



### 830.6320. Corrosion Characteristics A Not corrosive 

### 482585-05

830.7200. Melting point A Requested Waiver 

### 482585-01 (W)



### 830.7220. Boiling point A 177°C 

### 482585-04

830.7050. UV/visible light absorption A Neutral Media: Max "

at 207 nm. The 

### € (Log 1O)was4.13.
Acid Media: Max at
207 nm. The 

### € (Log

10) was 4.13. Basic
Media: Maximum at
213 nm. The 

### € (Log 

### 10) was 4.28.

4

### 830.7100 Viscosity 

### A 1374,3 Centistokes 

## ..

830.7370. Dissociation Constant 

### A pKa 

# = 1.09 

### 482585-01

Cited

830.7550. Partition Coefficient 

### A Log Kow 

# = 3.72 

### 482585-04

Cited

830.7950. Vapor Pressure 

### A 0.027 mPa@20 o 

### C 

## .. 0.056 mPa @25°C

830.7840. Solubility 

### A In water = 100 mg/L 

## .. @20 o 

### C

830.7000. pH 

### A 4.6 482585-04

830.7300. Density 

### A 1.287 

### g/cm 3 

## ..

Explanations: A 

# = Acceptable, NA 

# = Not applicable, G = 

### Data gap

5

### DP BARCODE 

### No.: 383714 EPA File Symbol 

### No.: 42750-EER PRODUCT NAME: 

### Propiconazole
Technical



### CONFIDENTIAL APPENDIX

Product identity 

### & composition (830.1550)



### Composition:

Product Name:

Chemical Name:



### IUPAC:



### CA:

CAS Registry Number:

Molecular Formula:

Molecular Weight

Structure: Propiconazole TGAI

t,:)-1-[2-(2,5-dichlorphenyl)_4_propyl_1 ,3-dioxolan-2-ylmelhylj_1 

### H1,2,4-triazole

1-U 2 -(2,4-dichlorophenyi)-4-propyl-1 ,3-dioxolan-2-yljmethylj-1 

### H1,2,4-triazole

60207-90-1

342.2



## a ,:7 

## a

0 

# "'"**H'C~** 

# ("**~~l** N

6

### i



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

Office of Chemical Safety and
Pollution Prevention



### March 29, 2011

MEMORANDUM

Subject: Name of Pesticide Product:

EPA File SymboL

DP Barcode:


### Decision No.:
Action Code:

PC Code: Propiconazole Technical



### 42750-EER

D383715

440858

R310

122101 Propiconazoie

From: Breann Hanson, Biologist 

# S**~ ~**  

# t
/ItA Ii j} 

### Technical Review Branch 

# cTRi35 - - -. "'

v v \.

### ~ Registration Division (RD; 7505P)



### To:

Applicant: Shaunta Hill/Shaja Joyner, RM Team 20 Fungicide Branch 

### Registration Division (7505P)



### Albaugh, Inc.

1525 NE 36'h Street Ankeny,IA 50021

FORMULATION FROM LABEL:

Active Ingredient

12210 1 Propiconazole 

### CAS No. 60207-90-1 % 

### bywt

96.5

Other Ingredients: 3.5

Total: 100.0%

### PC Code: 122101
EPA File Symbol: 42750-EER



### ACTION REQUESTED: The Risk Manager requests: "TRB/AT. 

### Please review the attached label, csf
and data matrix submitted in support of a new TGAI. No acute tox was submitted. A copy of the me-too product label is also enclosed

... "

BACKGROUND: Albaugh, Inc (herein the "registrant',) has applied for registration ofPropiconazole Technical, EPA File Symbol: 42750-EER, claiming similarity to another technical grade propiconazole product, Sharda Propiconazole Technical, EPA Reg. No. 82633-13. Included in the data package were the
label and basic CSF for the proposed product (CSF dated 8/0CT12010), 

### cited product label, data matrix
and letter from the registrant.

To satisfy the acute toxicity data requirements, the registrant has included a data matrix claiming the
"cite-all" method of data support. The registrant is claiming similarity to 82633-13, a technical grade product with a label declaration of 95 

### .4% Propiconazole. Acute oral, acute dennal, acute inhalation, primary eye irritation, primary skin irritation and dermal sensitization studies (MRIDs 477184-22, -19,

- 21, -20, -18, -23) were originally submitted for 82633-13 and reviewed by the Agency (Alternative Risk Integration and Assessment Team memorandum, B. Hanson, EPA File Symbol: 82633-RG, DP Barcode: 365254, 30/JUN/2009); the studies were all classified as Acceptable.

COMIVIENTS AND RECOMMENDATIONS:

1. TRB reviewed the cited acute toxicity data referenced above and determined that these data support the registration of the proposed product; the proposed and cited products are substantially similar in toxicity.

In addition, the proposed and cited product labels are substantially similar in labeling of use sites; both are manufacturing use products. The acute toxicity data reviewed for registration of 82633-13 can be cited for registration of 42750-EER.

2. The acute toxicity profile for the proposed product, Propiconazole Technical, EPA File Symbol: 42750-EER, is as follows:

acute oral toxicity

acute dennal toxicity

acute inhalation toxicity primary eye irritation primary skin irritation
dermal sensitization II cited


### III cited


### IV cited


### III cited

N 

### cited

POSITIVE cited 

### MRJD 47718422/EPA Reg. No. 82633-13

MRID 47718419/EPA Reg. No. 82633-13

MRID 4771842l1EPA Reg. No. 82633-13

MRID 47718420/EPA 

### Reg. No. 82633-13

MRID 47718418/EPA Reg. No. 82633-13

MRID 477184231EPA Reg. No. 82633-13

3. The proposed basic CSF must be reviewed and accepted by the TRB Product Chemistry Team.

4. The proposed label must be amended to include the Toxicity Category II signal word WARNING as well as the precautionary language for Category 

### 11 oral toxicity "May be fatal if swallowed". The precautionary statement should read (change in italics) "Avoid contact with 

### skin, eyes, or clothing." In addition, the Label Review Manual has recently been updated to include the statement (in 

### italics) "Wash thoroughly with soap and water.

.. 

### or using the toilet." Please revise the proposed label to include this language.

The cited label contains Worker Protection Standard (WPS) Personal Protective Equipment (PPE). Although WPS PPE is not required for manufacturing use products, the Agency may deem PPE necessary

to mitigate hazards. As the cited label contains PPE, this reviewer recommends that the proposed product
label also contain PPE.

Page 2 

### 00

### PC Code: 122101
EPA File Symbol:**42750~EER**



### 5. LABELING: Based on the toxicity profile above, the following are the precautionary and first aid

statements for this product as obtained from the Label Review System:

PRODUCT ID #: 

### 042750-00221

PRODUCT NAME: Propiconazole Technical

PRECAUTIONARY STATEMENTS
SIGNAL WORD: WARNING

Hazards to Humans and Domestic Animals: May be fatal if swallowed. Harmful if absorbed through skin.

Causes moderate eye irritation. Avoid contact with skin, eyes or clothing. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco or using the toilet. Wear long-sleeved shirt
and long pants, socks, shoes, and gloves. Remove and wash contaminated clothing before reuse. Wear protective

eyewear.

Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals.

First Aid:

Ifswallowed:
-Call a poison control center or doctor immediately for treatment advice.**~Have** 

### person sip a glass of water if able to swallow.

-Do not induce vomiting unless told to by a poison control center or doctor.

-Do not give anything to an unconscious person.

lfon skin:
-Take off contaminated clothing.
-Rinse skin immediately with plenty of water for 15-20 minutes.
-Call a poison control center or doctor for treatment advice.

lfin 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.
-Call a poison control center or doctor for treatment advice.

Have the product container or label with you when calhng a poison control center or doctor or going for treatment.
You may also contact**1-800-xxx~xxxx** 

### for emergency medical treatment information.

Page 3 of3

# Memorandum

Date: !O / iT[ / 

# La



# To:

__ .L?...LI::.LV]_--Jl2-,,--,QL.-.

___ ' 

# Regulatory Manager

From: Information Services Branch, ITRMD

Your receipt of this data submission is not an indication that MRIDs for the enclosed studies have
been posted to OPPIN.



# We expect that it will 

# be approximately 5 days
from the above date before the study-level data is
available in OPPIN.

If you have any questions about this process, please contact Teresa Downs (305-5363).

This is a:**~fully** 

# accepted submission



# o partially accepted submission



# o rejected submission

### study deficiencies (42750-EER) Tracy Jackson to: morrisg

Cc: Sree Nair

From: Tracy Jackson/DC/USEPAfUS

To: morrisg@aJbaughinc.com

Cc: Sree Nair/DC/USEPNUS@EPA

Dear Mr. Gaskins, 10/20/20 

## to 07:57 AM

I am contacting you regarding your submission of Propiconazole Technical**(42750~EER).** There were

some deficiencies found in studies submitted.



### Deficiencies:

1. Study number 2 titled Series 830-A Product Identity and Composition, Description of Materials Used to
Produce the Product, Description of Production Process, Discussion of Formation of Impurities, and
Certified Limits for Propiconazole TGAI. Project 10 ALB10-11 Pages 66, 67, 73-74, 77,**82~84,** 92, 95 and
96 of confidential attachment are all illegible.

2. Study number 5 titled One Year Storage Stability and Corrosion Characteristics of Propiconazole TGAI. Project number 01.11147.02.002B. The GlP Compliance statement which is on page 3 is missing a study

sponsor.

I did not see efficacy data on the data matrix, please verify if it is required.

The corrections can be sent to jackson.tracy@epa.gov

If you have any questions I can be reached at**703-308~7227**

Thank you

Tracy Jackson
Macfadden/EPA Contractor
2777 S. Crystal Drive Arlington, VA 22202From:

To:

Hi Tracy I 

### RE: study deficiencies (427S0-EER)
Morris Gaskins to: Tracy Jackson

Morris Gaskins <MorrisG@albaughinc.com>
Tracy Jackson/DC/USEPAlUS@EPA

We will try to rectify these issues ASAP this morning. 10/20/201008:02 AM

Efficacy data is not required for this application since there are no human
health claims being reg'd. This application is for regular agricultural and
turf uses only.

-----Original Message-----
From: Jackson.Tracy@epamail.epa.gov [mailto:Jackson.Tracy@epamail.epa.gov]
Sent: Wednesday, October 20, 2010 7:57 AM
To: Morris Gaskins
Cc: Nair.Sree@epamail.epa.gov Subject: study deficiencies (42750-EER)

Dear Mr. Gaskins,

I am contacting you regarding your submission of Propiconazole Technical (42750-EER). There were some deficiencies found in studies submitted.

Deficiencies:

1. Study number 2 titled Series 830-A Product Identity and Composition, Description of Materials Used to PrO,duce the Product, Description of production Process, Discussion of Formation of Impurities, and
Certified Limits for Propiconazole TGAI. Project ID ALB10-11 Pages 66, 67, 73-74, 77, 82-84, 92, 95 and 96 of confidential attachment are all illegible.

2. Study number 5 titled One Year Storage Stability and Corrosion
Characteristics of Propiconazole TGAI. Project number 01.11147.02.002B.
The GLP compliance statement which is on page 3 is missing a study

sponsor.

I did not see efficacy data on the data matrix, please verify if it is required.

The corrections can be sent to jackson.tracy@epa.gov

If you have any questions I can be reached at 703-308-7227

Thank you

Tracy Jackson
Macfadden/EPA Contractor
2777 S. Crystal Drive Arlington, VA 22202

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, 

### D.C. 20460



### ALBAUGH INC

1525 NE 36TH STREET ANKENY,IA 50021 October 20, 2010

Report of Analysis for Compliance with PR Notice 86-5 OFFICE OF PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES



### Thank you for your submittal of 12-0CT-IO. Our staff has completed a preliminary analysis of the material. The results are provided as follows:

Your submittal was found to be in full compliance with the standards for submission of

data contained in PR Notice 86-5. A copy of your bibliography is enclosed, annotated with

Master Record ID's (MRIDs) assigned to each document submitted. Please use these numbers in

all future references to these documents. Thank you for your cooperation. If you have any questions concerning this data submission, please raise them with the cognizant Product Manager, to whom the data have been released.

# PRIA 2 - 21 Day Content Screen Review Worksheet

(EP AlOPP 

### Use Only) 

# j A 

### -;2 

### 3/23/09 

### 21 Day Screen Start Date:

## _-,,-,,,(/_-.,,f~_f:,r0"- ______ 

# -= Experts In-Processing Signature: 

# '6. 7------ Date / 0 -I 

# t/" -10 

### Fee Paid: Yes /

Division management contacted on issues No,

___ yes

___ Date

_____ _

EPA Reg. Number:

# fI~ 

# 750

- E61!. EPA Receipt Date: 

# /15 - / :2 - / 0



### 1

2

3

4



### 5 

## Items for Review

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

### including package type

Confidential Statement of Formula all boxes completed, fann signed, and

dated (EPA Form 8570-4) (Link to form) a) All inerts (link to http://www.epa.gov/opprdOOllinertsl), yes no 

### including fragrances, approved for the proposed uses (see

Footnote A)



### Certification with 

### Respect to Citation of Data (EPA Fann 8570-34) (Link to Yes No 

## N/A*



# x

fonn) 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



### to pay statement included. (see Footnote. B) 

### yes. no

If applicable, is there a letter of Authorization for exclusive use only_

Formulator's Exemption Statement**(~P** 

### A Form 8570-27) (Link to fonn) completed and signed (N/A 

### if source is Wiregistered or applicant owns the technical)

Data Matrix (EPA Form 8570-35) (Link to fonn) both internal and external copies (pR 98-5) (Link to PR 98-5) completed and signed (N/A 

### if 100% /... repack)



### yes no 

## f-:"";.-.t--'''''--j .'**f--'a)'----S_e_le_c_ti_ve_M_eth_o_d_'(~F_ee_ca_t_'eg"o_ry'_:_e~xp'-e-rt_s_us~e)'----** _____

## -r=X~_--I".,:.~,,:.' 

# . '

b) Cite-All (Fee category experts use) 

# :-(:C.,,:>; ,'.""

.

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

,- 

### ,



### 5 Copies of 

### LabeI (link to http!llwww.epa.gov/oppfeadl!labeling/lrm!)

6 (Electronic labels on CD are encouraged and guidance is available)( link to \; hltp:llwww.epa.gov/pesticides/regulating/registering/submissions/index.htm#labels 

## ..I\..

: 

### )



### 1

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

# )(

Notice of Filing (link to


## 8**htm:/lwww.eQa.gov/I!esticideslr~ulatin1!ltolerance** 

### I!etitions,htm) included

with 

### petitions (link 

### to 

# --T--- http://www.epa.gov/pesticides!regulatingitolerances.htrn)

9 If applicable for conventional applications, reduced risk rationale (link to 

# rhttp://www.epa.gov/opprdOOliworkpianireducedrisk.htmI)



### Required Data (link to htm;/ /?<"'\vw 

### .eQa. gOY / 

### eestici desLregul atine! data 

### reguirements.htm) and/or
data waivers. See Footnote C.



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



### 10

2

### Comments:

'- 

## J (v: 

## fJ**~** 

## /! 

# >; ....,; ,.



# - ,

! .>! 'j



# * N/A

- 

### Not Applicable

Footnotes

A During the 21 day initial content review, all eSFs will be reviewed to detennine
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. fonns, data and
documentation resolving the inert issue must have been received by the Agency or the application withdrawn within the 21 day period, otherwise, the Agency will reject the application as described below.

To successfully complete this aspect of the 21 day initial content screen, applicants are strongly encouraged to verify that all inert ingredients have been approved for the application's uses even if 

### a product is currently registered by consulting the inert Web

3

### site [link to http://www.epa.gov/opprdOOllinelts/lists.htmll 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 (nAB) at inertsbranch@epa.gov and resolve the issue. Copies of the correspondence with HAB resolving the issue should accompany the application. All

new inerts except PIP inerts are reviewed by HAB. The nAB 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/oPObppdlfbiopesticides/contactsbppd.htm ].

VYhen a brand, trade, or proprietary name of an inert ingredient is listed on a CSF,
additional information such as an alternate name of the inert, CAS number or other
information [link to http://www.epa.gov/opprdOOllinerts/tips.pdf] must also be included

to enable the Agency to determipe 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. Ifthe inert ingredients in a proprietary blend (including fragrances)

cannot or are not identified or provided' wi thin the 21-day content review period, the Agency will reject the application.

During the 21 day content review, applicants should submit infonnation to the individual
identified by the Agency when the applicant is informed of an unapproved inert.

Unapproved Inerts Identified on CSFs

All applications except conventional new products and PIPs

Once an unapproved inert is identified on a CSF, the Agency will contact the applicant with the following 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 unapproved inert. If this option is selected and implemented, the Agency may request an extension in the PRIA decision review timeframe to accommodate
the inert review/approval process;

4

### 3. Withdraw the application (the Agency retains 25% of the full fee for the fee
category estimated); or

Ifnone 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 unapproved inert on a CSF with an application for a new product that the applicant has not identified as requiring an inert approval (R311, R3l2 or R3l3), 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 unapproved inert, including,any required petition to establish or amend a tolerance or**exemp~ion** 

### 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 2l-day

content-review period, the Agen9Y will reject the application and retain 2;5% 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 speliing or name of the

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

2. Submit the infonnation and data needed for the Agency to approve the unapproved inert. If an inert ingredient tolerance exemption petition is required, the petition must be received by the Agency and the B903 fee paid

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

## will discuss hannonizing the timeframe for both actions.

5

### 3. Withdraw the application (the Agency retains 25% of the full fee for the fee
category estimated); or

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

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

the fee.

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

me-too or fast track (similarlidentical) new product, R300 or A530, an application
without the necessary authorizations of offers to pay will be placed into either R301 or A531. The Agency recommends that 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

# NEW APPLICATIONS

DATE: OCT! 2 2010



# FILE NUMBER: _!iJ.750

- E£ 

# R.



# FEP (OPPIN ENTRY) LV /0/13(;)'010 

# (Initial 

# & date)

.



# FILE ROOl\1:

____**~_** 

# (Initial 

# & date)



# SIG: (Initial & date)



# FILE ROOM:

------ 

# (Initial & 

# date)



# / ASSIGN TO PM**~.2** 

# (NO DATA)



# _ JACKET TO SHELF (DATA)CORPORATE OFFICE

1525 NE 36th Street Ankeny. IA 50021

515.964.9444 (Phone)

800.247.8013 (Toll Freel

515.964.78t3 (FAX) 

# Al..BAUGH, IN'C.

October 8, 2010

Document Processing Desk (APPLY)
Ms. Shaja Joyner (Team 20) Registration Division
Office of Pesticide Programs (7504P)
U.S. Environmental Protection Agency
Room S-4900, One Potomac Yard (South Bldg)
2777 South Crystal Dr. Arlington, VA 22202

RE: Propiconazole Technical
EPA Reg. No.**42750~initial** application

Dear Ms. Joyner, 

### Fed-X GEORGIA OFFICE

P.O. Box 2127

Valdosta. GA 31604-2127

229.244.32BB (Phone)

229.244.5841 (FAX)



### 482585-00

This submission is Albaugh's initial application to register the above referenced product. This application is being submitted as a "me too" of Sharda's Propiconazole Technical (EPA Reg. No.**82633~13)** as approved by the Agency on 4/19/10.

Documents in support of this application are**detail~d** in the attached transmittal page.

Albaugh believes this application qualifies as a PRIA R300 classification with a 3 month review time and $1,434 fee.

Please call if you have any questions.

Regards,

# 1:!a~ Registrations Manager Albaugh, Inc.


### 229-244-3288



# Agri

# ~f,!t,~=.
PREMIER SUPPLIER OF**OFF~PATENT** CROP PROTECTION PRODUCTS wW\N.albaughinC.com

## TRANSMITTAL DOCUMENT

Name and address of submitter:

Albaugh, Inc.
P.O. Box 2127 Valdosta, GA 31604-2127

Company Official: Morris Gaskins



### Telephone: (229) 244-3288

Regulatory action for which this package is submitted:

Inttial application to register PROPICONAZOLE TECHNICAL

Transmittal Date: October 8, 2010

List of items submitted:

• Transmittal page

• Cover letter

• 8570-1 application form

• 8570-34 Certification Wtlh Respect to Citation of Data form

• 8570-35 Data Matrix (internal use copy)



### • 8570-35 Data Matrix (public file copy)

• Draft label (5 copies)

• Basic CSF (2 copies)



### • PRIA fee 

### check copy 

### & form

48258501. Summary of OPPTS 

### 830.1000 Series PrOduct Properties Test Guidelines (3 copies)



### 48268602. Series 830-A Product Identity and Composition, Description of Materials Used to Produce the Product, Description of Formulation Process, Discussion of Formation of Impurities, Certified 

### Limits, and Enforcement Analytical Method (OPPTS Guidelines 830.1550, 830.1600, 830.1620, 830.1670, and 830.1750) (3 copies)

48268603. Series 830-A Preliminary Analysis and Enforcement Analytical Methods (OPPTS Guidelines


### 830.1700 and 830.1800) (3 copies)

48268604. Series 830-8 Physical and Chemical Characteristics (OPPTS Guidelines 830.6302, 830.6303, 

### 830.6304, 830.6313, 830.7000, 830.7050, 830.7100, 830.7220, 830.7300, 830.7550, 830.7840, and 830.7950) (3 copies)

48268606. Series 830-8 Physical and Chemical Characteristics (OPPTS Guidelines 830.6317 Storage Stability and 830.6320 Corrosion Characteristics) (3 copies)

# 21-Day Screen Completed by

Contractor



# 21-Day Expires on 

# If

- 2 - 

# /0

Jacket # 1-(7.. 

# 7 

# SO

- EE.k. 

# MRID# Lf 

# (l 

# s 6 ::;



# Content Scree· ecommended to


# assl ail

86-5 

# Review: pGFailed/NA



# Transfer This Jacket 

# to:

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



### October 13,2010

PLEASE RETURN A COPY OF THIS LETTER WITH PAYMENT

Or 

### Pay On-Line at www.Pay.Gov (See Below for Details)

OPP Decision Number: D-440858

EPA File Symbol or Registration Number: 42750-EER

Product Name: PROPICONAZOLE TECHNICAL

EPA Receipt Date: 12-0ct-2010

EPA Company Number: 42750 Company Name: ALBAUGH INC

GREG MULHALL

ALBAUGH INC

1525 NE 36TH STREET ANKENY, IA 50021 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 for registration. 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 determined

that this Action is subject to a Pesticide Registration Service Fee as defined in the Pesticide Registration Improvement Act. c

### The Action has been identified as Action Code: R31 0

NEW PRODUCT;NON-F AST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PEST EFFICACY);

The fee associated with this action is $ 4,807. Payment in the amount of$ 1,434 has been

received. Please remit additional payment in the amount of$ 3,373 to:

By USPS:

USEPA Washington Finance Center

Pesticide Registration Service Fee

PO Box 979074 St. Louis, MO 63197-9000

### By Courier:

U.S. Bank

Government Lockbox 979074

1005 Convention Plaza

SL-MO-C2-GL

St. Louis, MO 63197 Telephone: (412) 236-2294

All payments must be in United States currency by check, bank draft, or money order

drawn to the order of the Environmental Protection Agency. To ensure proper credit, please

write the OPP DECISION NUMBER on your check, and enclose a copy of this letter with your payment.

Effective November 1, 2006, fees may be paid on-line via credit card or electronic fund

transfer. To submit a payment on-line, visit \VW\¥.pay.gov. From the pay.gov home page, select

"search by form name." From the next page, select "P," then click on "Pesticide Registration Improvement Act. Fee Payment" and complete the form, making certain to use the decision

number and registration number on the invoice you receive from the Pesticide Program in the

space provided.

You may be eligible for a partial waiver of the registration service fee if, for example, you qualify as a small business or are applying for a minor use, or if your application is solely

associated with an IR-4 tolerance petition. Please be advised that if you intend to request a waiver, you must do so in vvriting within 15 days of receipt of this invoice instead of remitting

the amount indicated above. OPP will not consider waiver requests after the registration service

fee has been paid. Information regarding eligibility and how th request and document a fee

waiver is available on the OPP Fee for Servic.e web site at 

### www.epa.gov/pesticides/fees.

Please send Registration Service Fee Waivetrequests to:

ByUSPS:

Document Processing Desk (WAIVER)

Office of Pesticide Programs (7504C)

U.S. Environmental Protection Agency

1200 Pennsylvania Ave NW Washington, DC 20460 By Courier:

Document Processing Desk (WAIVER)

Office of Pesticide Programs (7504C)

U.S. Environmental Protection Agency

Room S4900 Potomac Yard 1

2777 

### S. Crystal Dr. Arlington, VA 22202)



## )-4/ 

# IFee for Servicel {883693L-

,T_h_iS _pa_c_ka_ g e_i_nc_lu_de_s_th_e_fo_lIo_w_in_9---, 

# III for :AivisDion



# <!l New Registration

oBPPD 

# ° Amendment <!lRD**~Studies?** 

# o Fee Waiver?



# o vol pay 

# % Reduction:

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Receipt No. S-[ 883693

EPA File Symbol/Reg. No. !42750-EER 

# I

Pin-Punch Date:

. 

# I 10/1212010 

# I

o This item is NOT subject to FFS action.

Action 

# COdEr

Requested: 

# I R

- 3UD 

# I

Granted: 

# I iZ

- ') 10 

# I

Amount Due: 

# $ 

# L\0 C1 

# I' Parent/Child Decisions:

)

[jjj 

# Inert Cleared for Intended Use

Reviewer:

# ~1,lAl'''' 

# t'**(~** tl

Remarks:



# L1.IVL

# \~ .£: 

# 5 I Sic'l.-L 

# iL c?&Tch 

# Lt.

. Uncleared Inert in Product

Date: 

# i D 

# I 13 

# 110

r '

## A(}jaugfi Inc.

1525 XX. 36tfiSt. Anneny, Jawa 50021



# , WELLS FARG( .NK, N.A.

115 HOSPITAL DR., VA, ,'RT. OH 45891 56-3821412



### One thousand four hundred thirtv·four and xx / 100 Dollars 

### DATE 9/22/2010

PAYTOTHE

ORDER OF:



### .7tfljaug/i Inc.

VENDOR NO.: 11485 

### PRIA

USA

INVOICE REFERENCE
"cc NAME: PRIA

INV. DATE



### TOTALS,

, SUPERIORPRESS-(BB8)59{)-799B J81370161 ED SIGNATUAE

INV. AMOUNT DJSCQ!,.!NT ADJ. AMT.

# P."~f\ C 

### 01\

## ~"2-0 

# I z::. 

# 'fee**~\,,~** 

# I Ai 

# \J:--R "1 

# f 

# r. \.f'" 

# Ie**C;,sfJ~**



# f'KI**~** 

# i< 300

\,434.00 0.00



# .

, 

## , , , 

## , , • ,"



### ,

,>,

,



### • "



### , ' 

### , ,

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,



### ,),



### , 

# 080007

080007

AMT.**P~I~"** 

### nn

1,434.00

)" 

## ,

,**,~** 

### , ;,F TO... JOMB No. 201 •• •

.... 5

United Stetol 

# § Registration

Amendment

Other opp Identifier Number 

# oEPA Environmental Protection Agency

Washington, DC 20460



## Application for Pesticide" Section I

1.**Compflny'Pr'duc~~b'r** 

### 427S0·appl 

## t': f::J?

4. CompanYlProduct IName)



### Propiconazote Technical 2. EPA Product Menage' 

### S, Joyner

PM' 

### 22 3, Proposed Classification 

# [2] None 

# D

Restricted

5. Name and Address of Applicant (fncludfl ZIP Codal


### Albaugh, Inc,
P.O. Box 2127 6. Expedited Reveiw. In accordance with FIFRA Section 3(c)(3) )b)(i), my product is similar or identical In composition and labeling



### Valdosta, GA 31604-2127

## t~~A Reg. No. 

## _8_2_6_3_3_"_13

_________ _ 

# D

Check if rhis f$ II n8W addrtlSS Product 

### Name 

### Sharda Propiconazo!e Technical



## Section" "

Amendment· Explein below. Flnel printed labele in repeonsa to 

# o o 

# o Ruubmlssion in response to Agency letter detad

______ _ 

# u [2] Agency letter dated

_____________ 

### 1

"Me Too" Applicetion.

Notification

- Explein below. 

# o

Explanation: Ulle additional pagelsllf nllcllssary. IFor saction I and Saction 11.1

Initial application to register Othlr

- Explain below.

This application is being submitted under Ihe PRIA 

### n Fee for Service program as a EPA Class # R300 application with a 3 month review lime and a fee of $1 ,434.

A copy of AlbauQh check number 080007 that was submitted to the EPA 16ckbox concurrently with this application is enclosed.

,. Materiel Thle Produc1 Will Be Packe;ed tn:

Child·Reslstant Packeging 

# Dr"

l{jNe Unit Peckegin; 

# OV" lZl Ne 

## Section " '"

Wator Soluble Plckoging 

# Dr" l.{j No 2. Type of Conteiner

GIGls**~** Paper


### • Certific8tion must btl submitted If "Yo," No. por Unit Peckllging wgt. container If**··~III"** Package wgt No. per oontoiner

# ~:;:Ic

Othor {Specifyl

_______ .,

3. Locetion of Net Content, Information 4. Sizee.) Retan Contait)er 5. Location of Lobel Directions



## ({J Lebol 

# U Container 25Kg 

# t::3 On label atcached to contain,er

6.**Menn~r** in Which Lebel i, Affixed to Product 

# O Uthogreph 

# 0

" Peper 

# P,'"'" Stenci itd Other



## Section" 

## IV

1. Contect Point (Comp/tll. itums diruct/y below for fdentHic.tfon of fndividuBl to btl r;onf'llcttld, if nuctlSSory, to proc.ss thfs o/IP"cII,tion.)

, >**~** , ,**~** Nome TItia Telephontl'No. (Include Area Code)

Morris Gaskins Registrations Manager 229.244-3?8&' > , ,



### Certification

r certify that thll atetements 1 hove mode on thl' form end ,II attachments theroto are true, occurato end complete,

I acknowledge that ony knowlingHv false or misleading statament may be punishable by fina or Implisorvnant or both under appHclblo lew.

2. Signllturo 

## ""'-------i

a. D'llte Applic("ti.(Hh > ,

> Rer,eived : 

# >: : ' ) } (StampitJl > " :



## .

, 

### ,

,

, ,

, 

# /1 , 3. Title

I

## ~_ 

# A./ Regislrations Manager

# k-::----c-L+.~



# .**..,./~ d--~+-====-**  

# __ ---1"":'

4. Typed Name I 5. Ollte '"



### , Morris Gaskins 

## October 8,2010 ,), )

EPA Form 8670-t (Rn. 3-94) PreVIOUs edltlone Ifre obsolate. White

_ EPA Fila COllY larielnllll Yellow. AIwoIeant eo.,

..CORPORATE OFFICE

1525 NE 36th Street
Ankeny. IA 50021

515.964.9444 (Phone)

800.247.8013 IToll Freel 515.964.7813IFAX)

October 8,2010 

# AiBAUGH, It ·C.

Document Processing Desk (APPLY)
Ms. Shaja Joyner (Team 20) Registration Division
Office of Pesticide Programs (7504P)
U.S. Environmental Protection Agency
Room S-4900, One Potomac Yard (South Bldg)
2777 South Crystal Dr. Arlington, VA 22202

RE: Propiconazole Technical
EPA Reg. No. 42750-initial application

Dear Ms. Joyner, GEORGIA OFFICE

P.O. 80x 2127

Valdosta. GA 31604-2127

229.244.3288 (Phonel

229.244.5641 (FAX)

This submission is Albaugh's initial application to register the above referenced product. This appJlcation is being submitted as a "me too ff of Sharda's Propiconazole Technical (EPA Reg. No. 82633-13) as approved by the Agency on 4119110.

Documents in support of this application are detailed in the attached transmittal page.

Albaugh believes this application qualifies as a PRIA R300 classification with a 3 month review time and $1,434 fee.

Please call if you have any questions.

Regards,

# ~;a~ Registrations Manager Albaugh, Inc.


### 229-244-3288



# Agrl

# ~f1!,,~=o
PREMIER SUPPLIER OF OFF-PATENT CROP PROTECTION PRODUCTS \/VW'N.albaughinc.com

## TRANSMITTAL DOCUMENT

Name and address of submitter:

Albaugh, Inc.
P.O. Box 2127 Valdosta, GA 31604-2127



### Company OffIcial: Morris Gaskins

Telephone: (229) 244-3288

Regulatory action for which this package is submitted:

Initial application to register PROPICONAZOLE TECHNICAL

Transmittal Date: October 8,2010

List of items submitted:

• Transmittal page

• Cover letter

• 8570-1 application form

• 8570-34 Certification With Respect to 

### Citation of Data form

• 8570-35 Data Matrix (intemal use copy)



### • 8570-35 Data Matrix (public file copy)

• Draft label (5 copies)

• Basic CSF (2 copies)

• PRIA 

### fee check copy 

### & form

• Summary of OPPTS 830.1000 Series Product Properties Test Guidelines (3 copies)



### • Series 830-A Product Identity and Composition, Description of Materials Used to Produce the Product, Description of Formulation Process, Discussion of Formation of Impurities, Certified 

### LimMs, and Enforcement Analytical Method (OPPTS Guidelines 830.1550, 830.1600, 830.1620,830.1670, and 830.1750) (3 copies)

• Series 830-A Preliminary Analysis and Enforcernen1 Analytical Methods (OPPTS Guidelines


### 830.1700 and 830.1800) (3 copies)

• Series 830-B Physical and Chemical Characteristics (OPPTS Guidelines 830.6302, 830.6303, 830.6304, 830.6313, 830.7000, 830.7050, 830.7100, 830.7220, 830.7300, 830.7550, 830.7840, and 830.7950) (3 copies)

• Series 830-8 Physical and Chemical Characteristics (OPPTS Guidelines 830.6317 Storage Stability and 830.6320 Corrosion Characteristics) (3 copies)Form Approved OMB No. 2070-0060

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY


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

Paporwork Reduction Act Notice: The public reporting burden for this collection of Information is estimated to average 1.25 hours per response for registration
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 burden estimate or any other aspect of this collection of information, includtng suggestions for reducing (he burden to; Director, OPPE
Infonnation Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W

.. Washington, DC 20460.
Do not send the completed form to this address.



### Certification with Respect to Citation of Data

ApplicanfslRegistrant's Name, Address, and Telephone Number Albaugh, Inc. P.O. Box 2t27 Vatdosta, GA 31604

Active InQredient(s) and/or representative test compound(s) propiconazole

General Use Pattem(s) (list all those claimed for this product usinQ 40 CFR Part t58)

MUP for terrestrial food use, terrestrial non-food use EPA Registration NumberfFile Symbol

42750-init appl

Date
101e/10

Product Name Propiconazole Technical

NOTE: If your product is a 100% repackaging of another purchased EPA-registered product labeled for all the same uses on your label. you do not need to
submit this form. You must Submit the Fonnulator's Exemption Statement (EPA Form 8570-27). 

# o



# o I am responding to a Data-Call-In Notice, and have included with this fonn a list o( companies sent offers of compensation (the Data Matrix (orm should
be used for this purpose).

SECTtON t: METHOD OF DATA SUPPORT (Check one method only)

I am using the cite-all method of support, and have nciuded with this form

a list of companies sent offers of compensaUon (the Data Matrix form
shoutd be used for this purpose). I am using the selective method of support (or**rJt§!i1~** option under the selective method), and have included with thts form a compteted list of data requirements (the Data Matrfx'form must be used). ' "**~** ••

SECTtON It: GENERAl. OFFER TO PAY 

## " "

; 

### , 

# ·

• • 

# · • • • [Required if using the cite-all method or when using the cite-all option underthe selecllve method to saflsfy one or more data requ'lrementsj 

# · • • 

# o I hereby offer and agree to pay compensation, to other persons, with regard to the approval of this application, to the extent required by FI;;RA. 

# ·**U-----------------------------------------------------,-----------------------------------------;:"'!. !·!·"·--------~I**  

# 1f-

______________________________________ -Cs=E=ccnco:Ncc"CI,;C;ECRCTCIF;IC:A;T!':O!NC-

_________________________**·~·!·!·!·'~** 

## ______ 

## -il

I certify that this appflcation for registration, this form for reregistration, or this Data-Call-In response ts supported by all data submitte'd'of

## ~ted in the application for registration, the fonn for reregistration, or the Data-Call-In response. In addition, if the cita-all option or cite-all option under the selective method ts
indicated in Section I, this application is supported by all data in the Agency's files that (1) concern the properties or effects of this product"or an Identical or substantially similar product. or one or more of the ingredients in this product; and (2) is a Iype of data that would be required to be submitted under the data requirements in effect on the date of approval of this application if the application sought the initial registration of a product of identical or similar composition and

uses·

I cartify that for each exclusive use study cited in support of this registration or reregistration, that I am the original data submitter or that I have obtained
the written permission ofthe original data submitter to cite that study.

I certify that for each study cijed in support of this registration or reregistration that is not an eXClusive use study, either. (a) I am the original data submitter, (b) I have obtained (he permission of the original dala submitter to use the study in support of this apptication; (c) all periods of eligibility for compensation have expired for the study; (d) the stUdy is in the public titerature; or (e) I have notified in writing the company that submitted tha study and have Offered (I) to pay compensation to the extent required by sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA; and (ii) to commence negotiations to determine tha
amount and terms of compensation, if any, to be paid for the use of the study.

t certify that in all instances Where an offer of compensation is required, copies of all offers to pay compensation and evidence ofthetr delivery in accordance with sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA are available and wilt be submitted to the Agency upon request. Should I fail to produce such
evidence to the Agency upon request. I understand that the Agency may initiate action to deny, cancel or suspend the registration of my product in conformity**w~h** FIFRA.

t certify that the statoments t have made on this fonn and alt attachmonts to It arc true, accurate, and complete. I acknowledge that any knowingly false or misleading statement may be punlshabte by fine or imprisonment or both under appllcabto taw.

Signature 

# /J /) / Date Typed or Printed Name and TiUe 

# ,1'1'**~~~~~~ ~~~.,~~~~:=~~'O~18~/~10:.**  ..

# ==.L~M:'~rr:;~'~G:'~'k~;rr~'~;R~'~9~;':trn:t:;':rr:':M:'~rr~'g~':'== .. __ 

# .M**~E~P~A~F~'~""::::85:::':7~O:;~"4C(;;9';.9~7~) ~E~I'~d::ro~rr~'§':'~rrd"~** **ppf"p,::'~':erslons** avallabte Submit only Paper version.

## R 310

End Use IEP) or Manufacturing Use IMP) product or Technical Grade of the Active Ingredient ITGAI).
Must submit Group A and B proQuct chemistry data for each proposed product unless it's a 100%
identical (repack): YES or

### _NO~\ {circle one} 

# 'J

EP Data MP Dafa

Guideline 

### Group A: Product Chemistry Data Submitted Submitted 

### TGAI 

## No. SfudyTitle



# . Yes 

## No Yes 

## No Yes 

## No

830.1550 Product Identity & 

### Composition 

# !\
Description 

# of materials used to 

# I 830.1600 

# I produce the product

. 

## - ;; 

## ••
830.1650 Desq[Q}ion of formulation 

## orocess'**'./~** 

# X

830.1670 Discussion on the formation of impurities 

### y

830.1700 Preliminary analysis 

## X

830.1750 Certified limits 

### 1158.345) '-) 

# " 830.1800 Enforcement analvtical method 

## X "



### EP Data MP Data

Guideline Group B: Product Chemistry Oato study

## ~~~~L~~~~L~T~G~A~I~_-J

I 

### to normal and
I
Oxidation/Reduction

I I



### out == 

### not required



### 1

# R 310

New products must either: 1) supply the product specific acute toxicity 6 pack data (listed below),

or 2) provide a bridg'lng 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.

Data

Guideline Acute toxicity (6 pack) submitted 

### Cited

No. Study Title Yes No Yes No

870.1100 Acute Oral ILD50) 

## '/ "

870.1200 Acute Dermal ILD50) 

# /;

870.1300 Acute Inhalation (LC50) 

# :<

870.2400 

### Acute Eye Irritation 

# . -' \



### 870.2500 

### Acute Dermal**~rritation** 

## •

870.2600 Dermal Sensitization 

# i.

Efficacy

- which guideline is used depends on the proposed label use

Data

Guideline submitfed 

### Cited

No. Study Title Yes No Yes No Commenfs



### 810.3100 Soil Treatments for lroported Fire Ants**~** 

## .. (. " 

### Livestock, Poultry, Fur and Wool-Bearing

810.3200 Animal Treatments ;, ; 

## . Treatments to Control Pests of Humans

and
810.3300 Pets <e' 

### • 

# . Mosquito, Black Fly, and Biting Midge

810.3400 ISand Fly) Treatments .;**~**



### 810.3500 Premises Treatments

810.3600 

### structural Treatments


### Methods for Efficacy Testing of Termite

810.3800 Baits j "?' ,,( J 

# .J

;-/, 

# ,

2FormApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,DC20460- --PapelWorkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursresPJnseregictration2'_ctiviti3and0.25hoursresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendtegardbgmeoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivisionP:l3:?}tJ.s.Er:viroomentalPtotecticnAgency,401MStreet,SW.,Washington,DC20460.Donotsendtheformtothisaddress.-- - - , ,DATAMATRIXDate:10/8/10EPAReg.No./FileSymbol42750-xxxPage1of7Applicant's/Registrant'sName&Address:AlbaughInc.Product1525NE36-5t.PROPICONAZOLETECHNICALAnkenY.IA50021Ingredient:PropiconazoleCAS#60207N90-1--,,-GuidelineReferenceGuidelineStudyNameMRIDNumberSubmitterStatusNote830.1550ProductIdentityandCompositionWithapplicationAlbaughOWN830.1600DescriptionofMaterialsUsedtoProducetheWithapplicationAlbaughOWN830.1620DescriptionofProductionProcessWithapplicationAlbaughOWN830.1650DescriptionofFormulationProcess"Waiver2830.1670DescriptionofFormationofImpuritiesWithapplicationAlbaughOWN830.1700PreliminaryAnalysisWithapplicationAlbaughOWN830.1750CertifiedLimitsWithapplicationAlbaughOWN830.1800EnforcementAnalyticalMethodWithapplicationAlbaughOWN830.6302Color-WithapplicationAlbaughOWN830.6303PhysicalStateWithapplicationAlbaughOWN830.6304OdorWithapplicationAlbaughOWN-830.6313StabilitytoNormalandElevatedTemperatures,WithapplicationAlbaughOWNMetalsandMetalIons830.6314Oxidation/Reduction:ChemicalIncompatibilityNotreq'd1830.6315FlammabilityNotreq'd1830.6316ExplodabilityNotreq'd1830.6317StorageStabnityWithapplicationAlbaughOWNSignature/11,.a/NameandTitle:MorrisGaskinsDate:RegistrationsManager10/8/10r...r__<">,,.,,1>">".'nn"\[0,_......__,_...__•••,___,,_...,_"......•..__"r_r__"FormApprovedOMSNo.UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,DC20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponsefO!:regirtrationand025hcursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcom'iner:.tstecardiojgtheoranyotheraspectofthiscollectionofinformation,indudingsuggestionsforredudngtheburdento:Director,OPPEInformationManagementDivieon(21:37)Epvlronmen!'alAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress..,Date:10/8/10Applicant's/Registrant'sName&Address:AlbaughInc.1525NE36-5t.Ankeny,LA50021Ingredient:PropiconazoleCAS#1GuidelineReferenceNumberGuidelineStudyName830.6319Miscibility830.6320CorrosionCharacteristics830.6321DielectricBreakdownVoltageDATAMATRIXEPAReg.No./FileSymbol427S0-xxxProduct:PROPICONAZOLETECHNICAL...-MRIDNumberSubmitterStatusWithapplicationAlbaughOWN830.7000pH.Withapplication'AlbaughOWN830.7050UVfVisibieAbsorptionWithappl'lcationAlbaughOWN830.7100ViscosityWithappl'lcationAlbaughOWN830.7200MeltingPoint/MeltingRange830.7220BoilingPoint/BoilingRangeWithapplicationAlbaughOWN830.7300Density/RelativeDens"lty/BulkDensityWithapplicationAlbaughOWN830.7370DissociationConstantsinWater830.7550PartitionCoefficient(n-octanol/water),ShakeWithapplicationAlbaughOWNFlaskMetllod830.7560\PartitionCoeffic"lent(n-octa'nol/water),GeneratorColumnMethod830.7570IPartitionCoefficientEstimationbyLiquidChromatographySignatureNameandTitle:MorrisGaskinsL!JtRegistrationsManagerEPAForm8570-35(9-97)ElectronicandPaperversionsavailable.Submitonlypaperversion.AgencyIntemalUseCopyPage2of7--NoteNotreq'd1-tNotreq'd1IWaiver>Notreq'd1\Waiver4IWaiver4Date:10/8/10FormApprovedOMBNo,2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,DC20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponsefOrreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforredudngtheburdento:Director,OPPEInformationManagementDivision(2137)U.s.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDate:10/8/10EPAReg.No./FileSymbol42750-xxxPage3of7Applicant's/Registrant'sName&Address:AlbaughInc.Product:1525NESt.PROPICONAZOLETECHNICALAnkenv.IA50021Ingredient:PropiconazoJeCAS#60207-90-1GuidelineReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStatusNote830.7840WaterSolubiHy:ColumnElutionMethod;WithapplicationAlbaughOWNShakeFlaskMethod830.7860WaterSolubility,GeneratorColumnMethodWaiver830.7950.VaporPressureWithappncationAlbaughOWN.'r,_••870.1100AcuteOralToxicityRatCITEALLPAY870.1200AcuteDermalToxicityMRatCITEALLPAY870.1300AcuteInhalationToxicity-RatCITEALLPAY870.2400PrimaryEyeIrritationMRabbitCITEALLPAY870.2500PrimaryDermalIrritationCITEALLPAY870.2600DermalSensitizationCITEALLPAYSignatureNameandTitle:MorrisGaskinsDate:RegistrationsManager10/8/10_.._..-------_...---_...EPAForm8570-35(9-97)BectronicandPaperversionsavailable.SUbmitonlypaperversion.AgencyIntemalUseCopyFonnApprovedOMSNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet;S.W.WASHINGTON,DC20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,indudingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137)U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDate:8/12/10EPAReg.No./FileSymbol42750-xxxPage4of7Applicant's/Registrant'sName&Address:AlbaughInc.Product:1525NE36'"St.PROPICONAZOLETechnicalAnkeny,IA50021Ingredient:PropiconazoleCAS#60207-90-1GuidelineReferenceNumberGuidelineStudyNameJMRIDISUbmitter(EPACo.No.)StatusNote-Albauqhwillmakeoffers-to-paytothefollowingcompaniesthatappearonthecurrentdatasubmitterslistforpropiconazo/e.PropiconazoleGenericDataCite-AllSyngenta(100)PAYPropiconazoleGeneriCDataCite-AllBayerCropscience(264)PAYPropiconazoleGeneriCDataCUE-AllDuPont(352)PAYPropiconazoleGenericDataCite-All.--!BCManf,(1022)PAYPropiconazoleGenericDataCite-AllSayerCorp(3125)PAYPropiconazoleGenericDataCite-AllTroyChemical(5383)PAYPropiconazoleGenericDataCite-AllBASF(7969)PAYPropiconazoleGenericDataCite-AllAndersons(9198)PAYPropiconazo/eGenericDatame-AllMakhteshim(11678)PAYPropiconazo/eGenericDataCite-AllLovelandProducts(34704)PAYPropiconazoleGenericDataCite-AllJanssen(43813)PAYPropiconazoleGenericDataCite-All-BASFSparks(51036)PAYPropiconazoleGenericDataCite-AllControlSolutions(53883)PAYPropiconazoleGenericDataCite-AllConteohem(57227)PAYPropiconazo/eGeneriCDataCite-AllKop-Coat(60061)PAYPropiconazoleGenericDataCite-AllSipcamAgro(60063)PAYSignature£!1L-NameandTitle:MorrisGaskinsDate:RegistrationsManager10/8/10EPAForm8570-35(9-97)ElectronicandPaperversionsavailable.Submitonlypaperversion.AgencyIntemalUseCopyFormApprovedOMBNo.UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,DC20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinfonnation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137)U.s.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendthefonntothisaddress.DATAMATRIXiDate:8/12/10EPAReg.No./FileSymbol42750-XJO(IPage50f7Applicant's/Registrant'sName&.Address:AlbaughInc.Product:1525NE36fu5t.PROPICONAZQLETechnicalAnkeny,IA50021Ingredient:PropiconazoleCAS#GuidelineReferenceNumberGuidelineStudyNameMRIDSubmitter(EPACo.No.)StatusNotePropiconazoleGenericDataArchWoodProtection(62190)PAY,PropiconazoleGenericDataDow(62719)PAYProp!conazoleGenericDataMANA(66222)PAYPropiconazoleGeneticDataate-All".·C'..'.ArystaUfeScience(66330)PAYPropiconazoleGenericDataate-All5prayDriftTaskForce(66607)PAYPropiconazoleGenericDataDiaconTechnologies(70227)PAYPropiconazoleGenericDataCite-AllDr.WolmanGMBH(71406)PAYPropiconazoleGenelicData15KBiocides(71581)PAYPropiconazoleGenericDataNichino(71711)PAYPropiconazoleGenericDataGREfF(71754)PAYPropiconazoleGenericDataCite-AllAgRe-EntryTF(71755)PAYPropiconazoleGenericDataCite-AllBayerAdvanced(72155)PAYPropiconazoleGenericDataCite-AllZelam(72616)PAYPropiconazoleGenericDataCite-All5apstainInd.Group(73154)PAYPropiconazoleGenericDataCite-AllEndangeredSpeciesTF(73989)PAYSignatureNameandTitle:MorrisGaskinsDate:RegistrationsManager8/12/10/-M_._,___._.".......'-"'--_.---'-•__.T_'-_•••__f'__••FormApprovedOM6No.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,DC20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinfonnatlonisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInfonnationManagementDivision(2137)U.s.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendthefonntothisaddress.DATAMATRIXDate:8/12/10EPAReg.NO./FileSymbol427S0-xxxPage6of7Applicant's/Registrant'sName&Address:AlbaughInc.Product:1525NE36·5t.PROPICONAZOlETechnicalAnkeny,IA50021Ingredient:PropiconazoleCAS#1GuidelineReferenceNumberGuidelineStudyNameMRIDSubmitter(EPACo.NO.)StatusNotePropiconazoleGenericDataCite-AllOsmoseNewZealand(74405)PAYPropiconazoleGenericDataCite-AllResidentialExposureTF(74688)PAYPropiconazoleGenericDataSupremeChemicals(75082)PAYPropiconazoleGenericData,,'ArchWoodProtection(75101)PAYPropiconazoleGenericDataAgHandlersTF(75234)PAYPropiconazoleGenericDataCite-AllArchTreatment(75506)PAYPropiconazoleGenericDataCite-AliU5TriazoleTF(75576)PAYPropiconazoleGenericDataOte-AIIGro-Pro(7%76)PAYPropiconazoleGenericDataCite-AllPhoenix:Environmental(81943)PAYPropiconazoleGenericDataCite-AllEtigra(81959)PAYPropiconazoleGenericDataCite-AllJ.OliverProducts(83222)PAYPropiconazoleGenericDataCite-AllAmtide(83851)PAYPropiconazoleGenericDataCite-AllGESTF(84653)PAYSignatureNameandTitle:MorriSGaskinsDate:rj'VICYRegistrationsManager10/8/10"nA,,_0"..,,-,.,<:"'Q_Q7)Flprtmnir;mrlP;U1f'rvprc:innc:::Iv;:\il::lhlpC::llhmit,-,nlvn.:lnprvp...:inn('T_.....___••'r_f'__"·9pyFootnote1FootnotesforPROPICONAZOLETECHNICALDataMatrixPage5of5830.6314OXidation/Reduction:chemicalincompatibility830.6315Flammability830.6316Explodability830.6319Miscibility830.6321DielectricBreakdown830.7370DissociationsConstantThisdataisnotrequiredforTechnicalGradeorMUPproductsperProductPropertiesTestGuidelinesOPPTS830.1000(e)(2)(xi)(S)Table2Footnote2-830.1650FormulationProcess.Albaughrequestsawaiverforthisdatarequirement.PROPICONAZOLETECHNICALproductisnotdeliberatelyformulated,SeeGuideline830.1620Footnote3-830.7200MeltingPoint.Albaughrequestsawaiverforthisdatarequirement.PROPICONAZOLETECHNICALproductisnotasofldproduct.Footnote4-830.7560PartitionCoefficient,GeneratorColumnMethod-830.7570PartitionCoefficient,LiquidChromatographyMethod.AlbaughrequestsawaiverforthesedatareqUirements.AlbaughelectedtouseGuideline830.7550tosatisfythisdatareqUirement.Footnote5830.7860WaterSolubility,GeneratorColumnMethod.Albaughrequestsawaiverforthisdatarequirement.AlbaughelectedtouseGuideline830.7840tosatisfythisdatarequirement._iIiIHP'IWi1IWi1W'iW111=''"__'"'"®OO[Y?'<,CONFIDENJIALSTATEMENTOFFORMULAENCLOSED'"'''".>DoNotWriteComments,Formula,orPartsofFormulaonThisEnvelopeNOTEHshallbeunlawful--forany·persontouseforhisownadvantageortoreveal,otherthantotheSecreta!!'oroffidalsoremployeesof"the'UnltedStatesOepartmentofAgrIcultureor'otherFederalagencies,ortothecourtsInresponse'toasubpoena.ortophysicians.andInemergenciestophannaclstsandotherqualifiedpersons,foruseInthepreParationofantidotes,InaccordancewithsuchdltectJonr-astheSecretinymayprescribe;anyInformationrelativetoformulasofproductsacquiredbYauthorityofSection4ofthe-Federallnsectldde,Funglctde.andRodentlddeAct...I!USDA-US