EPA Jacket 42750‐221
1

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 
2

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) 
3

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 

," , ,,' ) 

, , 

, , , , " , 

'"'' ' 
4

ALBAUGHe 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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5

f!fu,.,..d i".t . • b.lo,. to .. '" " A rove. 

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 . . 
6

FEE FOR SERVICE 
7

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 305-5721 
8

48519501 

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 
9

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. 
10

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 
11

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) 
12
13

.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 
14

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. 
15

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 Division 
16

S)'4" ·-0"'0«"" '" r, ";t, 

:s: \''''", '1 w '" o '''\<;1' " 'fl', 'q' ,,,," ? ;10:,,,,.· 'i 0: 

<';,. ,.;,."'- 'v)' <,.C 4! PRO' .... 

Company Name 

Telephone Number 

Decision Number 

U.S. Environmental Protection Agency 

Office of Prevention, Pesticides and Toxic Substances 

Pesticide Registration Improvement Act Fee Payment 

Please fiJI in the form completely 

Click Submit Data to make your payment 

I f;F19 _ . ,;:;"C< Contact Name lI"lifr"/.$ (;C.."krM 

I 

I 

Email Address Registration Number 

I /'1.,rr/$51@o../b<>-,-,,jt.. i'"lC. <:.0-"1 

I .if.2-7!>C -.,:;.:L/ 

• 

Payment Amount 

,-I 

C 0/1.,,·.2&> Ie:. VecA Ai 

/II" J-f:2-7!>O_ 

;<, 3 "fo &7'"" rF"r /"l".""t; 

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17

nhHE LOWER CORNER OFTHIS CHECK MUST FADE TEMPORARILY WHEN WARMED BYTO'UCH OR FRlcndN: 

.JlJJjaugh Inc. 

1525 :N.'E. 36tli St. 

Jtweeny, Iowa 50021 

WELLS FARGO ;BANK, N,A . 

VAN WERT. OH 

800·289·3557 

!l6-332f412 

083840 

Three thousand six hundred seventeen and xx 1 100 Dollars DATE 

5/512011 

, AMOUNT 

PAYTOTHE DRDEROF: 

P RIA 

USA 

--------.,,"' ,----"-----

*************3.617.00 

•. v ..... 

.. &. 

,,"-' AUTHOflIZED SIGNATURE " 

'" ._- ------- ... _-,------, '.' 

.JlIljaugfi Inc. 083840 

VENDOR NO.: 11485 NAME: PRIA 

INVOICE REFERENCE INV. DATE INV. AMOUNT DISCOUNT ADJ. AMT. AMT, 

'" ."",00 

Pro( ) C.OI\p-<-D 1 c '1 ect,,,,; C"'-

7S""O - ;2...7-- , 

I!. 3 0 14 <f'"r ... 11: tv..-f: 50v rce 

. , 

· " · . , , · , " 

TOTALS: 3,617.00 0.00 3.617.00 

• SUPERIOR PRESS 

1 

*Commercial/financial information may be entitled to confidential treatment*
18

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 
19

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 
20

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 

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

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 
21

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 
22

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 
23

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 
24

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. 

6 
25

PI •••• ,..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" 

.f N, .f N, . gM"" ./ 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 Copy 
26

CORPORATE 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 
27

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) 
28

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. 
29

Form A

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, DC 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registratio

response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments rega

other aspect of this collection of information, including suggestions for redudng the burden to: Director, OPPE Information Management Division (2137) u.s. 

Agency, 401 M Street, S.W., Washington, DC 20460, Do not send the form to this address. 

DATA MATRIX 

Date: 6/23/2011 EPA Reg. No./File Symbol 427

Applicant's/Registrant's Name & Address: Albaugh Inc. Product 

1525 NE 5t. PROPICONAZOlE 

Ankeny,IA 50021 

Ingredient: Propiconazole CAS # 60207-9D-l 

Guideline Reference Guideline study Name MRIDNumber Submitter St

830.1550 Product Identity and Composition With application Albaugh 

830.1600 Description of Materials used to Produce the With application Albaugh 

830.1620 Description of Production Process With application Albaugh 

830.1650 Description of Formulation Process 

830.1670 Des.cription of Formation of Impurities With application Albaugh 830.1700 Preliminary Analysis With application Albaugh 

830.1750 Certified Limits With application Albaugh 830.1800 Enforcement Analytical Method With application Albaugh 830.6302 Color 482585-04 Albaugh 

830.6303 Physical State 482585-04 Albaugh 

830.6304 Odor 482585-04 Albaugh 830.6313 Stability to Normal and Elevated Temperatures, 482585-04 Albaugh 

Metals and Metal Ions 

830.6314 Oxidation/Reduction: ChemiC?l1 830.6315 Flammability . . . · "," 

. . . · . 

830.6316 

830.6317 Storage Stability" w . 482585-04 Albaugh 

. , . . 

-

. 

Signature • · . . A.: Name and Title: Morris Gaskins 

/) . _. ; --4' . -';)-0:?' -. Registrations M

.-n. r-

___ _ 

.... ,....,1'> .., ... , ........ .." .... __ , ___ ...I n ____ .. ____ .. _"_L'_ ..... 1-.. , .. __ , •• _____ •• ___ , __ .. ____ • ____ ' •• __ 
30

Form A

UNITED STATES ENVIRONMENTAL PROTECfION AGENCY 

401 M Street, S.W. 

WASHINGTON, DC 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registratio

response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments rega

any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) 

Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this address. 

DATA MATRIX 

Date: 6/23/2011 EPA Reg. No./File Symbol 42750-22

Applicant's/Registrant's Name & Address: Albaugh Inc. Product: 

1525 NE 36fu St. PROPICONAZOlE TECH

Ankeny, IA 50021 

Ingredient: Propiconazole eftS # 60207-90-1 

Guideline Reference Number Guideline Study Name MRIDNumber Submitter 

830.6319 Miscibility 

830.6320 Corrosion Characteristics 482585-04 Albaugh 830.6321 DielectriC Breakdown Voltage 830.7000 pH 482585-04 Albaugh 830.7050 UV /Visible Absorption 482585-{)4 Albaugh 

830.7100 Viscosity 482585-{)4 Albaugh 

830.7200 Melting Point/Melting Range 

830.7220 Boiling Point/Boiling Range 482585-04 Albaugh 830.7300 Density/Relative DenSity/Bulk Density 482585-04 Albaugh 

830.7370 Dissociation Constants in Water 

830.7550 Partition Coefficient (n-octanol/water), Shake 482585-04 Albaugh 

flask Method 

830.7560 Partition Coefficient (n-octanol/water), 

Generator Column Method 

830.7570 Partition Coefficient:(n-0ctandl/watEr), 

Estimation by Liquid'tnrmnatogrdphy w 

Signature .. Name and Title: Morris Gaskins 

... 

Registrations Mana

'-

... A ... 

____ .-.r..,,, -. .... ,n .-."'7'1 .-,_ ..... ___ ' ___ .... n ____ . ___ ,_ ... __ .. _.,,_ _ ..... 0... "'" __ I .. ""' __ __ •• ___ , __ A _____ ____ III __ 

. " 
31

Form Ap

UNrrED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S. W. 

WASHINGTON, DC 20460 

Paperwork Reduction Act. Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registratio

response fOr reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments rega

any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) 

Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this address. 

DATA MATRIX 

Date: 6/23/2011 EPA Reg. No./File Symbol 42750·

Applicant's/Registrant's Name &. Address: Albaugh Inc. Product: 

1525 NE 36- 5t. PROPICONAZOLE TEC

Ankeny, IA 50021 

Ingredient: Propiconazole CAS # 60207-90-1 

Guideline Reference Number Guideline Study Name MRlDNumber Submitter 

830.7840 Water Solubility: Column Elution Method; 482585·04 Albaugh 

Shake Flask Method 

830,7860 Water Solubility, Generator Column Method 830,7950 Vapor Pressure 482585-04 Albaugh 870,1100 Acute Oral Toxicity - Rat CITE All 

870,1200 Acute Dermal Toxicity - Rat OTEAll 

870,1300 Acute Inhalation ToxiCity Rat OTEALL 870.2400 Primary Eye Irritation Rabbit CmAll 

870.2500 Primary Dermal Irritation cmAll 870,2600 Dermal Sensitization CITE All 

-" "'-

" " , " -. "" "' "-,, 

" " , , , '" 

Signature Name and Title: Morris Gaskins 

:;/:" RegIstrations Mana

[OnA oO:::'fl . .':>o:' In n,' t:ln ........... ... ,,_ ...... ....... II ... 
32

Form Ap

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, DC 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registratio

response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments rega

any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) 

Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this address. 

DATA MATRIX 

Date: 6/23/2011 EPA Reg. No./File Symbol 42750-22

Applicant's/Registrant's Name StAddress: Albaugh Inc. Product: 

1525 NE 36'h 5t. PROPICONAZOLE 

Ankenv.1A 50021 

Ingredient: Propiconazole CAS # 

Guideline Reference Number T Guideline study Name T MRID I Submitter (EPA Co. No.) 

Albaugh will make to the following companies that appear on the current data submitters list for propiconazole. 

Propiconazole Generic Data ate-All Syngenta (lOO) 

Propiconazole Generic Data Cite-All Bayer Cropscience (264) Propiconazole Generic Data . DuPont (352) 

Propiconazole Generic Data Cite-All IBC Manf. (1022) 

Propiconazole Generic Data Cite-All Osmose (3008) Propiconazole Generic Data Cite-All Bayer Corp (3125) Propiconazole Generic Data Cite-All Troy Chemical (5383) 

Propiconazole Generic Data Cite-All BASF (7969) Propiconazole Generic Data Andersons (9198) 

Propiconazole Generic Data Cite-All Makhteshim (11678) Propiconazole Generic Data Loveland Products (34704) 

Propiconazole Generic Data ate-All Nufanm Limited (35935) 

- - Propiconazole Generic Data Cite-All - - Janssen (43813) •. - 

o " __ 

. 

-- -

Propiconazole Generic Data Cite-All . - - . · BA5F Sparks (5lO36) 

--

Propiconazole Generic Data Cite-All Control Solutions (53883) 

Propiconazole Generic Data Cite-All 

-

.. 

.. . . . · - Contechem (57227) 

• - - - · . 

-- -' . -. . . • _., - --

Signature a'-.: Name and Title: Morris Gaskins 

Registrations Manage

_. 

EPA Form 8570-35 Electronic and Paper versions avai , 'Submit only paper versio, '. 

A 

____ 

• 

___ 

,gency lal Use 
33

Form Ap

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S. W. 

WASHINGTON, DC 20460 

Paperwork Reduction Act Notice: The pUblic reporting burden for this collection of information is estimated to average 0.25 hours per response for registratio

response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments rega

any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) 

Agency, 401 M Street, SW., Washington, DC 20460. Do not send the form to this address. 

DATA MATRIX 

Date: 6/23/2011 EPA Reg. No./File Symbol 42750-22

Applicant'S/Registrant's Name & Address: Albaugh Inc. Product: 

1525 NE 36· 5t. PROPICONAZOLE 

Anken IA 50021 

Ingredient: Propiconazole CAS # 60207-90-1 

Guideline Reference Number Guideline study Name MRIO Submitter (EPA Co. No.) 

Propiconazde Genelic Data Cite-All Kop-Coat (60061) 

Propiconazole Generic Data Cite-All 5ipcam Agro (60063) 

Propiconazole Generic Data ate-All Tessenderlo Kerley (61842) 

Propiconazole Genelic Data ' Cite-All Arch Wood Protection (62190) Propiconazole Genelic Data Cite-All Dow (62719) Propiconazole Generic Data Cite-All MANA (66222) 

Propiconazole GeneriC Data Cite-All Arysta UfeScience (66330) Propiconazole Generic Data Cite-All Spray Drift Task Force (66607) 

Propiconazole Genelic Data Cite-All Repar (69361) Propiconazole Generic Data ate-All Diacon Technologies (70227) 

Propiconazole Generic Data Cite-All Dr. Wolman GMBH (71406) 

Propiconazole Generic Data Cite-All 15K B"ocides (71581) 

,,,, 

Propiconazole Generic Data Cite-All • · · ...· Nichino (71711) 

· · · . - .-- Propiconazole Generic Data Cite-All · .. · - · GRETF (71754) 

Propiconazole Generic Data Cite-All Ag Re-Entry TF (71755) 

w . 

. . . . · . 

. - . - · . 

- -

. - . . --

Signature .. ., · . . Name and Title: Morris Gaskins 

'fi;;;- · .. /2--v"-", Registrations Manage

[On.- [0_ <,>[0..,,, ."". '1"0 ".." "',_ ..... ___ : ___ ..I n ____ .. __ _ .. _:1 ... ,_ co..... __ , .. _____ .. ___ : __ A ____ • T_ ..... ___ , , , __ 
34

Form Ap

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, DC 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registratiO

response for reregistration and special review activities, induding time for reading the instructions and completing the necessary forms. Send comments rega

any other aspect of this collection of information, including suggestions for reducing the burden to: Director, QPPE Information Management Division (2137) 

Agency, 401 M Street, S.W., Washington, DC 20460, Do not send the form to this address. 

DATA MATRIX 

Date: 6/23/2011 EPA Reg. No./File Symbol 42750-22

Applicant's/Registrant's Name &.Address: Albaugh Inc. Product: 

1525 NE 36" St. PROPICONAZOLE 

Ankenv. IA 50021 

Ingredient: Propiconazole CA5 # 60207-90-1 

Guideline Reference Number Guideline Study Name MRID Submitter {EPA Co. No.} 

Propiconazole Generic Data ate-All Bayer Advanced (72155) 

Propiconazole Generic Data Cite-All Zelam (72616) Propiconazole Generic Data Cite-All Sapstain Ind. Group (73154) 

Propiconazole Generic Data Cite-All Endangered Species 1F (73989) 

Propiconazole Generic Data Cite-All Irvita Plant Protection (74054) Propiconazole Generic Data Cite-All Osmose New Zealand (74405) Propiconazole Generic Data Cite-All Residential Exposure TF (74888) 

Propiconazole Generic Data Cite-All Supreme Chemicals (75082) 

Propiconazole Generic Data Cite-All Arch Wood Protection (75101) Propiconazole Generic Data Cite-All Ag Handlers TF (75234) 

Propiconazole Generic Data Cite-All Arch Treatment (75506) Propiconazole Generic Data Cite-All US Triazole TF (75576) 

Propiconazole Generic Data Cite-All Gro-Pro (79676) 

-

w _ 

Propiconazole Generic Data Cite-All . - - . o " v - Phoenix Environmental (81943) 

- -- · ... Propiconazole Generic Data Cite-All - -- · .. Etigra (81959) 

--

. 

- . 

- · . - -- • · . · . . · - • - .. Signature Name and Title: Morris Gaskins 

Registrations Manage

I:OnA n""r. '31:." 'n n"'" 1:01_ ............ _: ___ .-I n ___ ,. __ __ _,._,,_ 1_ l' •• t.: __ I,. _____ ,._ , __ (9-97) p' Iy pap' A ____ • ____ ' 11 __ 

.gency 
35

Form Ap

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, DC 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration 

response for reregistration and special review activities, induding time for reading the instructions and completing the necessary forms. Send comments regar

any other aspect ofth'ls collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) U

Agency, 401 M Street,. S.W., Washington, DC 20460. Do not send the form to this address. 

DATA MATRIX 

Date: 6/23/2011 EPA Reg. No./File Symbol 42750-22

Appllcant's/Registrant's Name & Address: Albaugh Inc. Product: 

1525 NE 36" St. PROPICONAZOLE 

AnkenY. IA 50021 

Ingredient: Propiconazole CAS # 

Guideline Reference Number Guideline Study Name MRID Submitter (EPA Co. No.) 

Propiconazole Generic Data Sharda USA LLC (83529) 

Propiconazole Generic Data Amtide (83851) Propiconazole Generic Data ate-All GESTF (84653) Propiconazole Generic Data Cite-All . . Berkem Develop (86505) Propiconazole Generic Data Cite-All Willowood Propiconazole, LLC 

Propiconazole Generic Data Gte-Ali . Willowood USA, LLC 

. 

. 

-

· ... ·· · : ::: . 

. 

v " . 

· • . - · . · · . · · • • . . .. .. -- · -. . · • · .. • ., i Signature M,.,../'J/- Name and Title: Morris Gaskins 

Registrations Manage

- __ ___ n_' _. . . " ,. -

, 

., . .. - -". -
36

Footnote 1 

Footnotes for PROPICONAZOLE TECHNICAL Data Matrix 

Page 8 of 8 

- 830.6314 Oxidation/Reduction: chemical incompatibility 

830.6315 Flammability 

- 830.6316 Explodability 

- 830.6319 Miscibility - 830.6321 Dielectric Breakdown - 830.7370 Dissociations Constant 

This data is not required for Technical Grade or MUP products per Product Properties Test Guidelines OPPTS 830.1000 (e)(2)(xi)(B) Table 2 

Footnote 2 

- 830.1650 Formulation Process. Albaugh requests a waiver for this data requirement. PROPICONAZOLE TECHNICAL product is not delibe

830.1620 

Footnote 3 

- 830.7200 Melting Point. Albaugh requests a waiver for this data requirement. PROPICONAZOlE TECHNICAL product is not a solid prod

Footnote 4 

- 830.7560 Partition Coefficient, 'Generator Column Method 

- 830.7570 Partition Coefficient, Uquid Chromatography Method 

Albaugh requests a waiver for these data reqUirements. Albaugh elected to use Guideline 830.7550 to satisfy this data requirement. 

Footnote 5 

830.7860 Water Solubility, Generator Column Method. Albaugh requests a waiver for this data requirement. Albaugh elected to use Gu

data requirement. 

"W"", 

"" 

"" " 
37

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 19,2008 
38

U.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 
39

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 703M3437-8961 or by email at hill.shaunta@epa.gov 

or myself at 703M308M3194 or joyner.shaja@epa.gov. 

Shaja B. Joyner 

Product~anager(20) 

Fungicide Branch 

Registration Division (7504P) 
40

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' 

" " , " . , , , , , , . . " " ," , , , '" . . , , " " 

", > 

1 
41

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 

, , , • > , , , , , , > , , , , > 
42

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 

, , , , , , 

, " , , 

, , > , , , , , , , 
43

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 .. 

. . . 

""" , 

J , , > 

", , , , > , , , 

• • 

• • " , , , , , , , , , , , 

0' " 

," , 4 

. . 

" 
44

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 

*Product ingredient source information may be entitled to confidential treatment*
45

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. 

2 

*Manufacturing process information may be entitled to confidential treatment*
46

DP BARCODE No.: 383714 EPA File Symbol No.: 42750w 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 
47

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 
48

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@20oC .. 

0.056 mPa @25°C 

830.7840. Solubility A In water = 100 mg/L .. 

@20oC 

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 
49

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-U2-(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 
Pages 50-72-*Manufacturing process information may be entitled to confidential treatment*
73

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 

Registration 

Review 

Division 

Branch 

(RD; 

cTRi35 

7505P) 

- - -. "' v v \. ~ 

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% 
74

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 
75

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 
76

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 
77

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 22202 
78

From: 

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 
79

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. 
80
81

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 
82

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 

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

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

http://www.epa.gov/opprdOOliworkpianireducedrisk.htmI) rRequired 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 
83

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 
84

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 
85

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 
86

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 
87

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) 
88

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 
89

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) 
90

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: 
91

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. cThe 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 
92

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 
93

) 

)-4/ 

IFee for Servicel {883693L-

,T_h_iS _pa_c_ka_ge_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: __ Risk Mgr. 

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 ISic'l.-L iL c?&Tch Lt. . 

Uncleared Inert in Product 

Date: i D I 13 110 r ' 
94

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 

. 

, , , , , , • 

," , ,>, , 

• " , ' , , 

." , 

,), , 

080007 

080007 

AMT. P~I~" nn 

1,434.00 

)" , , ,~ , ;, 

*Commercial/financial information may be entitled to confidential treatment*
95

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" " 

o Amendment· Explein below. Flnel printed labele in repeonsa to 

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., .. 
96

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 tooff 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 
97

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) 
98

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. 
99

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 
100

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 ;-/, , 

2 
101 Form A

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, DC 20460 - 

PapelWork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours resPJnse regictratio

response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send tega

other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division P:l3:?} tJ.s. 

Agency, 401 M Street, SW., Washington, DC 20460. Do not send the form to this address. 

DATA MATRIX 

Date: 10/8/10 EPA Reg. No./File Symbol 427

Applicant's/Registrant's Name & Address: Albaugh Inc. Product 

1525 NE 36- 5t. PROPICONAZOLE 

AnkenY. IA 50021 

Ingredient: Propiconazole CAS # 60207 N 90-1 

Guideline Reference Guideline Study Name MRID Number Submitter St

830.1550 Product Identity and Composition With application Albaugh 830.1600 Description of Materials Used to Produce the With application Albaugh 

830.1620 Description of Production Process With application Albaugh 

830.1650 Description of Formulation Process" 830.1670 Description of Formation of Impurities With application Albaugh 830.1700 Preliminary Analysis With application Albaugh 

830.1750 Certified Limits With application Albaugh 830.1800 Enforcement Analytical Method With application Albaugh 

830.6302 Color - With application Albaugh 

830.6303 Physical State With application Albaugh 830.6304 Odor With application Albaugh 830.6313 Stability to Normal and Elevated Temperatures, With application Albaugh 

Metals and Metal Ions 

830.6314 Oxidation/Reduction: Chemical Incompatibility 

830.6315 Flammability 

830.6316 Explodability 

830.6317 Storage Stabnity With application Albaugh Signature /11,. a/ Name and Title: Morris Gaskins 

Registrations M

r ... r 

__ <">,,.,,1> ">". 'n n"\ [0,_ ...... __ ,_ ... __ ••• , ___ ,,_ ... ,_ "...... •.. __ "r_ 
102 Form Ap

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, DC 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response fO!: regirtration 

response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send com'iner:.ts tecar

any other aspect of this collection of information, induding suggestions for redudng the burden to: Director, OPPE Information Management Divieon (21:37) 

Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this address. ., 

Date: 10/8/10 

Applicant's/Registrant's Name & Address: Albaugh Inc. 

1525 NE 36- 5t. 

Ankeny,LA 50021 

Ingredient: Propiconazole CAS # 1 

Guideline Reference Number Guideline Study Name 

830.6319 Miscibility 

830.6320 Corrosion Characteristics 830.6321 Dielectric Breakdown Voltage 

DATA MATRIX 

EPA Reg. No./File Symbol 427S0-xx

Product: 

PROPICONAZOLE TECH

... 

-

MRIDNumber Submitter 

With application Albaugh 

830.7000 pH . With application' Albaugh 

830.7050 UVfVisibie Absorption With appl'lcation Albaugh 830.7100 Viscosity With appl'lcation Albaugh 830.7200 Melting Point/Melting Range 830.7220 Boiling Point/Boiling Range With application Albaugh 830.7300 Density/Relative Dens"lty/Bulk Density With application Albaugh 

830.7370 Dissociation Constants in Water 830.7550 Partition Coefficient (n-octanol/water), Shake With application Albaugh 

Flask Metllod 

830.7560 \ Partition Coeffic"lent (n-octa'nol/water), 

Generator Column Method 

830.7570 I Partition Coefficient 

Estimation by Liquid Chromatography 

Signature Name and Title: Morris Gaskins 

L!Jt Registrations Mana

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only paper version. Agency Intemal Use 
103 Form A

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, DC 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registratio

response fOr reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments rega

any other aspect of this collection of information, including suggestions for redudng the burden to: Director, OPPE Information Management Division (2137) 

Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this address. 

DATA MATRIX 

Date: 10/8/10 EPA Reg. No./File Symbol 42750-

Applicant's/Registrant's Name & Address: Albaugh Inc. Product: 

1525 NE St. PROPICONAZOLE TEC

Ankenv.IA 50021 

Ingredient: PropiconazoJe CAS # 60207-90-1 

Guideline Reference Number Guideline Study Name MRID Number Submitter 

830.7840 Water SolubiHy: Column Elution Method; With application Albaugh 

Shake Flask Method 

830.7860 Water Solubility, Generator Column Method 

830.7950 . Vapor Pressure With appncation Albaugh 

. 'r,_ • • 

870.1100 Acute Oral Toxicity Rat CITE ALL 870.1200 Acute Dermal Toxicity M Rat CITE ALL 870.1300 Acute Inhalation Toxicity - Rat CITE ALL 

870.2400 Primary Eye Irritation M Rabbit CITE ALL 870.2500 Primary Dermal Irritation CITE ALL 

870.2600 Dermal Sensitization CITE ALL 

Signature Name and Title: Morris Gaskins 

Registrations Mana

_ 

.. 

_ 

.. 

------ -_ ..

EPA Form 8570-35 (9-97) Bectronic and Paper versions available. SUbmit only paper version. Agency Intemal Use 
104 Fonn Ap

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street; S.W. 

WASHINGTON, DC 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registratio

response for reregistration and special review activities, induding time for reading the instructions and completing the necessary forms. Send comments rega

any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) 

Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this address. 

DATA MATRIX 

Date: 8/12/10 EPA Reg. No./File Symbol 42750-xx

Applicant's/Registrant's Name & Address: Albaugh Inc. Product: 

1525 NE 36'" St. PROPICONAZOLE 

Ankeny, IA 50021 

Ingredient: Propiconazole CAS # 60207-90-1 

Guideline Reference Number Guideline Study Name J MRID I SUbmitter (EPA Co. No.) 

Albauqh will make offers-to-pay to the following companies that appear on the current data submitters list for propiconazo/e. 

Propiconazole Generic Data Cite-All Syngenta (100) 

Propiconazole GeneriC Data Cite-All Bayer Cropscience (264) Propiconazole GeneriC Data CUE-All DuPont (352) 

Propiconazole Generic Data Cite-All .- - !BC Manf, (1022) Propiconazole Generic Data Cite-All Sayer Corp (3125) 

Propiconazole Generic Data Cite-All Troy Chemical (5383) 

Propiconazole Generic Data Cite-All BASF (7969) Propiconazole Generic Data Cite-All Andersons (9198) Propiconazo/e Generic Data me-All Makhteshim (11678) 

Propiconazo/e Generic Data Cite-All Loveland Products (34704) Propiconazole Generic Data Cite-All Janssen (43813) Propiconazole Generic Data Cite-All - BASF Sparks (51036) 

Propiconazole Generic Data Cite-All Control Solutions (53883) 

Propiconazole Generic Data Cite-All Conteohem (57227) 

Propiconazo/e GeneriC Data Cite-All Kop-Coat(60061) Propiconazole Generic Data Cite-All Sipcam Agro (60063) 

Signature £!1L- Name and Title: Morris Gaskins 

Registrations Manage

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only paper version. Agency Intemal Use 
105 Form A

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, DC 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registratio

response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments rega

any other aspect of this collection of infonnation, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) 

Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the fonn to this address. 

DATA MATRIX 

Date: 8/12/10 EPA Reg. No./File Symbol 42750-XJO

Applicant's/Registrant's Name &. Address: Albaugh Inc. Product: 

1525 NE 36fu 5t. PROPICONAZQLE 

Ankeny, IA 50021 

Ingredient: Propiconazole CAS # 

Guideline Reference Number Guideline Study Name MRID Submitter (EPA Co. No.) 

Propiconazole Generic Data Arch Wood Protection (62190) 

Propiconazole Generic Data Dow (62719) 

Prop!conazole Generic Data MANA (66222) 

Propiconazole Genetic Data ate-All " .·C'. .' . Arysta UfeScience (66330) 

Propiconazole Generic Data ate-All 5pray Drift Task Force (66607) 

Propiconazole Generic Data Diacon Technologies (70227) Propiconazole Generic Data Cite-All Dr. Wolman GMBH (71406) Propiconazole Genelic Data 15K Biocides (71581) Propiconazole Generic Data Nichino (71711) 

Propiconazole Generic Data GREfF (71754) 

Propiconazole Generic Data Cite-All Ag Re-Entry TF (71755) 

Propiconazole Generic Data Cite-All Bayer Advanced (72155) 

Propiconazole Generic Data Cite-All Zelam (72616) 

Propiconazole Generic Data Cite-All 5apstain Ind. Group (73154) Propiconazole Generic Data Cite-All Endangered Species TF (73989) 

Signature Name and Title: Morris Gaskins 

Registrations Manage

/ 

- M _._ , ___ ._ ." . . ..... '- "'- -_.- --' - • __ .T_'-_ ••• _
106 Form A

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, DC 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of infonnatlon is estimated to average 0.25 hours per response for registratio

response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments rega

any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Infonnation Management Division (2137) 

Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the fonn to this address. 

DATA MATRIX 

Date: 8/12/10 EPA Reg. NO./File Symbol 427S0-xx

Applicant's/Registrant's Name & Address: Albaugh Inc. Product: 

1525 NE 36· 5t. PROPICONAZOlE 

Ankeny,IA 50021 

Ingredient: Propiconazole CAS # 1 

Guideline Reference Number Guideline Study Name MRID Submitter (EPA Co. NO.) 

Propiconazole Generic Data Cite-All Osmose New Zealand (74405) 

Propiconazole Generic Data Cite-All Residential Exposure TF (74688) Propiconazole Generic Data Supreme Chemicals (75082) 

Propiconazole Generic Data , , 'Arch Wood Protection (75101) Propiconazole Generic Data Ag Handlers TF (75234) 

Propiconazole Generic Data Cite-All Arch Treatment (75506) Propiconazole Generic Data Cite-Ali U5 Triazole TF (75576) Propiconazole Generic Data Ote-AII Gro-Pro (7%76) 

Propiconazole Generic Data Cite-All Phoenix: Environmental (81943) Propiconazole Generic Data Cite-All Etigra (81959) Propiconazole Generic Data Cite-All J. Oliver Products (83222) Propiconazole Generic Data Cite-All Amtide (83851) Propiconazole Generic Data Cite-All GESTF (84653) 

Signature Name and Title: MorriS Gaskins 

rj'V ICY Registrations Manage

"nA ,,_ 0"..,,-, .,<:" 'Q_Q7) Flprtmnir ;mrl P;U1f'r vprc:innc: ::Iv;:\il::lhlp C::llhmit ,-,nlv n.:lnpr vp...:inn (' T_ ..... ___ •• 'r_ 

·9 
107

Footnote 1 

Footnotes for PROPICONAZOLE TECHNICAL Data Matrix 

Page 5 of 5 

830.6314 OXidation/Reduction: chemical incompatibility 830.6315 Flammability 

830.6316 Explodability 

830.6319 Miscibility 

830.6321 Dielectric Breakdown 

830.7370 Dissociations Constant 

This data is not required for Technical Grade or MUP products per Product Properties Test Guidelines OPPTS 830.1000 (e)(2)(xi)(S) Table 2 

Footnote 2 

- 830.1650 Formulation Process. Albaugh requests a waiver for this data requirement. PROPICONAZOLE TECHNICAL product is not delib

830.1620 

Footnote 3 

- 830.7200 Melting Point. Albaugh requests a waiver for this data requirement. PROPICONAZOLE TECHNICAL product is not a sofld prod

Footnote 4 

- 830.7560 Partition Coefficient, Generator Column Method 

- 830.7570 Partition Coefficient, Liquid Chromatography Method. 

Albaugh requests a waiver for these data reqUirements. Albaugh elected to use Guideline 830.7550 to satisfy this data reqUirement. 

Footnote 5 

830.7860 Water Solubility, Generator Column Method. Albaugh requests a waiver for this data requirement. Albaugh elected to use G

data requirement. 
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CONFIDENJIAL STATEMENT OF FORMULA ENCL

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Do Not Write Comm

Formula, or Parts of 

on This Envelop

NOTE 

H shall be unlawful--for any ·person to use 

or to reveal, other than to the Secreta!!' or o

the'Unlted States Oepartment of AgrIculture or 

or to the courts In response'to a subpoena. o

emergencies to phannaclsts and other qualif

the preParation of antidotes, In accordance w

the Secretiny may prescribe; any Information 

products acquired bY authority of Section 4 of t

Funglctde. and Rodentldde Act. .. 
Pages 109-113-*Confidential Statement of Formula may be entitled to co