EPA Registration Jacket 57538-27 
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JUL 27 2006 

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

Ms. Alice Walker, Ph.D. 

StoUer Enterprises, Inc. 

clo Alice Walker Consulting 

3094 Country Club Rd. 

Senatobia, MS 38668 

r.!OV 2 1 2806 

Subject: Stoller Enterprises, lnc., Technicailndole-3-But}'ric Acid 

EPA Registration No. 57538-27 

Fonnulation Amendment to Add an Alternate Fonnulation Containing an Alternate 

Source of IBA 

Application Dated 7127106 

Dear Dr. Walker: 

The amendment referred to above., submitted in connection with registration under FIFRA 

section 3(c)(7)(A), is acceptable provided that you submit andtor cite all data required for 

registration/reregistration of your product under FIFRA section 3(c){5) when the Agency requires all 

registrants of similar products to submit such data. 

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

accordance with FIFRA section 6(e). Your release for shipment of the product bearing the amended 

product constitutes acceptance of these conditions. 

If you have any questions, contact Chris Pfeifer at phone# 703-308-0031 or by email at 

pfcifer.chris@Yoa.gQv . 

Sincerely. 

)c-~,.4Jk\ 

Linda Hollis, Chief 

Biochemical Pesticides Branch 

Biopesticides and Pollution 

Prevention Division (7511P) 

CONCURRENCES 

'YMOOt ~ :;9.11P. ..................................................... -................................................................................................................. .. SURNAME rl """,,",I"rel> 

DATE ~I .. :·~t~· ..................................................................................................................................................... . EPA FOm'l132b-'YA (1190) 
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Chris, 

Nino 

SlmeonovaJDCIUSEPMJS 

11/1512006 01:46 PM 

To ChrIs PfeiferIDCfUSEPAfUS@EPA 

ee 

bee 

Subject Re: 57538-27~ 

The corrections made with today's submission from AW. upgrade the application for alternate source of 

57538--27 to acceptable. As for the certified limits, they are acceptable as proposed by the applicant 

under 4OCFR1 58.175 (c). And what they decided for: ? It is OK to submit only 

upper limit for an impurity, but everything thal is reasonably based on the analysis and their experience 

must be accepted. 

Nina 

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*Manufacturing process information may be entitled to confidential treatment*
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l':'IlTED STATES ENVIRONMENTAL PROTECTION AGEKCV 

WASJIINGTON. D,C. 20460 

(lfFl(E OF 

PltEnXnOS,I'ESTIC1DES 

,\1'\D TOXIC Sl'BSTANCES 

ME"'IORA:-(DLM 

DATE: Octoher 19.2006 

SUBJECT: Altemute .$ourct' for Tcdmit.:al Indolt!-3-Butyric Acid, EPA 

Reg. No. 57538-27. Active [ngrcdicllt: 99 %'J Indole-3-

flut,ric Acid, PC' C'nuc 046701, C ASRK 133-32-4. 

Dccision #: 368451. Dr.: (331567). y!RID 468649-0 I. 

Currently registered CSF dated 03/15/06. Draft amendt!(l 

CSF dated 06!1 3/2006. /) 

REVIEWER: "ina SimcQllova, Chemist 0£ ~">1CV't Biopesticidcs ami Pollution Prevention Division (PY I) 

Biochemical Pesticides Branch 

TO: Chris Pfeifer. RA L 

Biopestil:ides lIlld Pollution Prevention Divisi(Jn (P'{ I) 

Biochemical Pesticides Branch 

Action Requested 

Stoller Enrcrpri::.cs, lllc. requests regislration orthc producer 

based in China amlnol regisfcred with EPA, as <lltenntc-soun..:c offndole-3-Bntyric 

At.:id (lBA. PC Code 04670 I, CASRN 5753H-27) in the product Technical Il1dolc-3~ 

Butyric Acid. EP;\ Reg. ;.10. 57538-27. In the currently registered CSF from 03i15/06 

the producer is Lianytlngang CCA CiH.-'mical Co. Ltd. (China), also not registered witll 

r:pA. supplying Il3A with 9\).0 % nominal concentration in certified limits 100-96.4 'Yo. 

rhe only manutaeturing impurity in the currently registered product is f18 

in certified limits 

In stlppon of the request the .applit.:ant submitted the study MRID 468649-01. dnltl 

aiteillale ('SF rrom 06/13/2006 :ll1d D;lt;1 Matrix. 

Conclusions and the- recummendations 

I. The amdysis of live batches ofTCiAI Indole-3-Butyric Acid produced by 

) is pcrfonncd by validated I-IPLC 

procedure \vith intemal standard Indnlt'-3-Acetie Acid and l}V-detection. The 

The Document contains Confidential Business Information 

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*Manufacturing process information may be entitled to confidential treatment*
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Multiple data arc obtained through the validation 

procedure and the assny of IBA and in the hatches. The tinal results are 

generated by statistical treatment. The results are acceptahle. 

2. The submitted study MRiD 468649~OI identifies the product from the alternate 

pmduccr to be of equulquality in comparison with the currently registered 

prllduct. The both lIominal conct:ntrations arc 99.0%) in .sclfproposed certified 

limits of 100 % - 96 %. The only manufacturing impurity in the both products is 

as in amount with self proposed certified limits of 

3. The application for registJ<ltioil of the alternate producer 

is m.:ecpWble provided the applicant submit concise 

infonnatioll ahl)ut the alternate manutacturing process, as re{luired by 

..tOCFRs 162 lor integrated TGAis and address the issue about the lack of 

manutacturing impurities other than . 

Study Summary 

MIUO 46S649~O I. Validation ofAualvtieal YJethodQ!ogy Klr the Assay orIndolc-3~ 

Butyric Acid and Process Related Signitieam Impurities of Indole-3~Butvrie Acid 

and Subsequent 5~Batch Analvsis ofIndole-3-Butvric Acid TGAI. The study 

contains stntcmeiltS of Data Confidentiality, compliance with GlP and Quality 

AS.wfance. In a Confidential Attachment it contains Final Report abollt tlte 

validution ortlle an<1lytical pnlcedure and the results from the dctennination of 

Indolc~3~ }3utvric Acid and in Batches 050724, 050726, 050727. 

050728 ami 050730. produced by The data 

are summan/ed in Tabl!;" 5 nn p. I S. AI! the actions connected with the validation 

pnlt~edurc and the assays orthe active in.b'Tcdient and in the technical product 

are documcnted lind the e\'itlence is nrgani/,ed in Attachmcnts as lolh)ws: 

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In Atladnnent A: All the laboratory records for weightings and 

preparatil)U5 of solutions from the retcrcnce standlmis and Ihc technical 

prodncts. propcrtks of the relctenee substances and certificates of 

;]I1alysis.: 

In Atlad1l1H!nt B: List oj" CDdL'~ It)r cmn:ctI(ln or ditlcrcnt types of errors: 

In Attachment C: All the receipts from shipping and storing the samples 

and records or the sttlra~'.tc conditions ( temperature, humidity); 

In Appendix D: Oetailcd description of the analytical procedure including 

Idcntiflcilttnn of the chemicals, the equipment, conditions of 

chnlIlUltographic separalion and mode of calculations: 

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*Manufacturing process information may be entitled to confidential treatment* *Product ingredient source information may be entitled to confidential treatment*
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hI Attachment E: All the raw data. chromntuh'TamS and results froll! the 

estimation of the precision of the 3naiy1icai il1cthQd~ 

In Attachment F: All the mw data. chrumatograms and results from the 

estimation of the accuracy of the anai)<ticai method; 

Tn Attachment G: All the raw data, chromatograms and results from the 

aS~<1y orth~ active ingredient iRA in the technical products: 

In Appendix H: Protocol tillm the perfomling laboratory 

\t1cKe;:nzielWright Laboratories L1.C (Bryan, TX). 

Classification: acccptahlc . 

cc: J\. Simconovn. Chris Pfeifer. DPPD Subject File, II-tAD Datahuse. 

:--J. Simconova, PY I, (703) 308~()291. IO/19i}()06 . 

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BASIC CHECK LIST FOR 

CONFIDENTIAL STATEMENT OF FORMULAS (CSF) 

Please note that if you have any questions at any point, especially with chemical or microbial names, 

consult with a chemist! product characterization scientist. (Freshteh, Paul, Russ, Carl, Michael T. W. 

or Chris). It may be helpful to make a copy of the CSF for marlring comments, questions, and needed 

corrections. Upon completion of this fonn, consult the above scientists. And have them check over 

the CSF along with your comments. 

EPA Regll/ File Symbol: 57538-27 CSF dated: 11/816 

I. Compare CSF with prior CSF(s), and determine what is different. 

Notes: NA 

2. Examine label, Docs this product have food or feed use sites? No 

REVIEW DUE DATE: 12/6/6 

e 3. Is each field filled out on CSF? 0" yes CJ no 

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Missing: NA. 

4. Is box 18 signed? It1 yes C no 

5. Are addresses complete, including zipcodes in boxes 1,2, and II? f!Jyes Ono 

Deficiencies: 

6. Have they enclosed a Material Safety Data Sheet (MSDS) for each new ingredient? 

ItJ yes Dna 

Deficiencies: NA. 

Please note thaI when the PPCV system is functioning agaill most of this infomwtionjor 7-12 C(lll 

be obtained on-line. Some of the codes may be listed on prior CSFs inprodllctjacket . 

7. In column 10. for each component is the chemical name, trade name and CAS No, listed? Is it 

clear what each component is? (May need to consult Farm Chern Handhook, Chemical Catalogs, or 

other references of Zubkoff or Toghrol) 

For any microbial ingredient, in column 10 - the description should include Colony fotming units per 

gram (CFUIg) and cell collection identity number (E.g. ATCC 889-34.) 

621 yes 0 no 

Deficiencies: NA. Evervthing is accounted for. 

8. Using a chemical catalog, or Refs verify the CAS #, and chemical name for each component under 

consideration. Also Note any toxicological information disclosed in catalog. 

Deficiencies: NA. CAS#s arc corrcct. 

9. Detennine PC codes for each component and write these in "EPA USE ONLY" column. Docs 

each component have PC Code? (Notebooks with PC codes arc in Filc room. REFS lists PC codes 

for Active ingredients.) If code(s) are not found, it may be necessary to send request fonn to Linda 

Fan 

PC Codes are written in CQlumn. 

9 
10. For each inert component detennine whether it is listed under 40 CFR 180.1001 (c)(d) (e). And 

write these codes in "EPA USE ONL yl! column. (Names may be confusing~ consult with a chemist if 

needed) If/his product is for feed or/ood Ilse, all inert ingredients MUST have appropriate 

clearance. 

Deficiencies: NA. However. aU ingredients are cleared for fuod/feed lL.<;C. 

11. For each inert component that does not have (c)(d) or (e) clearance detennine whether it is a Jist I, 

2,3, 4(a), or 4(b) inert. Write this information in"EPA USE ONLY" column. References to 

consult: www.cpa.gov/opprdOOI/inertsandFRVoI.63.No. 121 pages 34384-34390. Ifnny of the 

inert ingredients are listed as nNo longer used" in the above FR voJ.63 notice, or are on list 1 or 2, this 

is a problem to bring attention to chemist. 

Problem inerts? NA. However, inerts arc cleared. 

12. Ifproduct used on food or feed, confinn active ingrcdient(s) has an established tolerance or 

exemption from food tolerance. (Consult Alphabetical listing in part 180 of 40 CFR pages 2%-300, or 

the pesticide petition file jacket) !tIyes Cno Deficiencies: All cleared. 

• 13. Do certified limits for EACH component agree with 40 CPR 158.175? 

:51% N± 10%N N x l.l NxO.9 

>1% but N±5%N N x 1.05 N x 0.95 

>20% N ±3o/oN N x 1.03 N x 0.97 

N=amount 

Calculate upper and lower limits using table above and compare with those listed 

in colunans 14 a. and 14 b. of submitted CSF. If they do not agree, identify diffcrencc(s): The 

registrant has proposed broader limits for which is classified as an impurity. This has been e reviewed and found acceptable. 

14. Does the sum of the numbers in column 13, a, equal total listed in box 17? 

!t'1 yes Ono 

15 Does column 13. b. add up to loo%? Ii1 yes Cno 

16. If Alternative Fonnulation box is checked in box A- Is there another CSF for a Basic 

Formulation on file?? 0 yes Uno 0 NA 

17. Other issues? NA 

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*Manufacturing process information may be entitled to confidential treatment*
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DATA EVALUATION RECORD 

INDOLE-3-BUTYRlC ACJD 

(TECHNICAL fl\'DOLE-3-BUTYRlC ACID) 

STUDY TYPES: Product Identity and Composition (OPPTS 830.1550) 

Description of Beginning Materials (OPPTS 830.1600) 

Description of Formulation Process (OPPTS 830.1650) 

Discussion of Formation oflmpurities (OPPTS 830.1670) 

Preliminary Analysis (OPPI'S 830.1700) 

Primary Reviewer: 

Certified Limits (0 PPTS 830.1750) 

Enforcement Analytical Method (OPPI'S 830.1800) 

Physical and Chootical Characteristics (OPPTS 830.6302-830.7950) 

MRID 46864901 

Prepared for 

Biopesticides and Pollution Prevention Division 

Office of Pesticide Programs 

U.S. Environmental Protection Agency 

One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Prepared by 

Toxlcology and Hazard Assessment Group 

Life Sciences Division 

Oak Ridge National Laboratory 

Oak Ridge, TN 37830 

Task Order No. 06-088 

Susan Chang. M.S. Signature: 

Dale: 

Secondary Reviewers: 

Sylvia Milanez, Ph.D .• D,A.B.T. Signature: 

Date: 

Robert H. Ross. M.S .. Group Leader Signature: 

Date: 

Quality Assurance: 

Lee Ann Wilson, M.A. Si!:,TJlaturc: 

Date: 

Disclaimer 

This review may have been altered sllbsequent to the contractor's signatures above. 

Oak Ridge Kational Laborlliory manag¢d and opt:ralcd by CT·Battetle, LLC., tilT the U,S. Department of Energy llllder 

ContracrNo. DE~AC05-(tOOR22725. 

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DATA EVALUATIO/\ RECORD 

EPA Secondary ReYiewer: 

STt:DY TYPE: 

MRID NO: 

DP BARCODE :"10: 

CASE :-10: 

DECISION NO: 

TEST :VIATERlAL: 

PROJECT /\0: 

SPONSOR: 

TESTING FACILITY: 

TITLE OF REPORT: 

AUTHORS: 

STUDY COMPLETED: 

GOOD LABORATORY 

PRACTICE: 

CONCLUSION: 

Prodnct Identity and Composition (OPPTS 830.1550) 

Description or Beginning Materials (OPPTS 830.1600) 

Description ofFornlUlation Proccss (OPPTS 830.1650) 

Discussion of Formation of Impurities (OPPTS 830.1670) 

Prelil1linaIY Analysis (OPPTS 830.1700) 

Certified Limits (OPPTS 830.1750) 

Enforcement Analytical Method (OPPTS 830.1800) 

Physical ,md Chemical Characteristics (OPPTS 

830.6302-830.7950) 

46864901 

DP331567 

Not reported 

368451 

Technicallndole-3-butyric acid (EPA Reg No. 57538-27; 

99.0% w!w indolc-3-butyric acid, a.i.) 

MKLOS-Ol03 (Study ~o.) 

Stoller Enterprises. Inc., Houston, TX 

McKenzie/Wright Laboratories, LLC, Bryan, TX 

Validation of Analytical Methodology for the Assay of 

Indole-3-Butyric Acid and Process-Related Significant 

ImplIfitics of Indole-3-Blltyrie Acid and Subsequent 

5-Batch Analysis oflndole-3-Butyric Acid TGAI 

.vLC. \Vnght (ShIdy director) 

April 19,2006 

GLP Compliant 

Technical indole-3-butyric acid (EPA Reg.>Jo. 57538-27) 

is;1 rcgistered manufacturing-use prodnct C'vtP) and a 

plant growth regulator. Tho registrant wishes 10 add an 

alternate producer of T eehnical Jndolc-3-Butyric acid. 

The active ingredient in the alternate source material is 

99.0% w/w indolc~3-butyric acid and the impurity is 

w/w The analytical enforcemcnt method for 

indole-3-butyric acid is all HPLC-LV/VIS internal 

standard method (:VIWL method PRM-074). A five batch 

analysis of Indole-3-hntyric acid TGAI (alternate 

producer: for 

aclive ingredient percent composition was perlomled. 

The indole-3-butyric aeid ranged from 99.21 to 99.75% 

with an average 0(99.50+0.101 % and the 

content ranged from with an average of 

Total mass accountability for the five 

12 

*Product ingredient source information may be entitled to confidential treatment* *Manufacturing process information may be entitled to confidential treatment*
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CLASSIFICATION: 

batches ranged !i-om with an average of 

The lower and upper certified limits of 

the active ingredient are withiu the recommended range in 

guideline OPPTS 830.1750. The description of beginning 

materials. description of fonnulation process, and lhe 

physical and chemical characteristics were not addressed 

and presumably will be bridged from the data for the 

registered product. 

ACCEPTABLE 

*CONTluNS COKFIDEKTIAL B1JSIKESS INFORMATION' 

Test Material: Technical indole-3-but}'l'ic acid containing 99.0% w/w indole-3-butyric acid (lBA), a.i. 

I. PRODUCT lDE:>iTITY A:>iD COMPOSITIO]\': Technicallndolc-3-Butyric Acid (EPA Rcg Ko. 

57538-27) is a manufacturing-use product (~P) and a plant growth regulator. The regislrant wishes 

lo add an alternate producer of Technical Indole-3-Butyric Acid. The active ingredient in the 

alternate source material is 99.0% w/w indolc-3-butytic acid (CAS Kos. 133-32-4; PC code 046701) 

and thc impurity is

Deficiencies: None 

II. DESCRIPTION OF BEGII\l\"ING MATERIALS: Kol addressed and presumably will be bridged 

from the data for the rehJistered product. 

III. DESCRIPTION OF FORM.ULATION PROCESS: }lot addressed and presumably will be 

bridged from the data for the registered product. 

IV. DISCUSSION OF FORMATION OF TMPURll'IES: was lhe only impurity in the 

TGAl. Ko organic impurities such as illdole. indo1c-3-carbinol, or indole-3-carboxylic acid were 

found with the HPLC proce-dure . 

Deficiencies: None 

V. PRELIMINARY A..'1ALYSIS: Preliminary analysis instrumentation for the analytical reference 

standard includes 

e 

2 13 

*Manufacturing process information may be entitled to confidential treatment* *Quality control process information may be entitled to confidential treatment*
• 

By these evahtations, the method was 

judged to perform \\,'jth an acceptable accuracy and precision for forml1lation analysis. 

The fivc batch analysis ofTndole~3~Butyric Acid TGAI (alternate producer: 

for active ingrcdient percent composition was perfonncd. TItC il1dole~3~butyric 

acid ranged from 99.21 to 99.75% with <In average of99.50=0.201 % and the 

ranged from with an average of . Total mass accountability for the five 

batches ranged from with an average of

Deficiencies: Kone 

VI. CF.RTIFIF..D LIMITS: Tcchnicallndole-3-Butyric Acid contains 99.0%.1 by weight (limits of 

96.0~ 100%. by wcigltt) indole-3~butyric acid Cfable 1). The lower and upper certified limits for 

arc The jower and upper certified limi ts of the active ingredient arc within the 

recommended range in guideline OPPTS 830.1750 . 

Deficiencies: >-fonc 

TABLE t. Nominal CSF COIlC(!lltraJinns .and limits for Tcchnicalindote-3~butyric .acid~ 

Ingredients (CAS nUlI1bl'r) PC Code Purpose Cuncentration (% bv weight 

\'()minat I Lower I Cpper 

Active Ingredient 

Indole-3-butyric acid (133-32.4) 046701 AClivc 9'J,()'~. I'M% jlOO% 

tmpurity 

I 1

e . Data from CSF. 

VII. ENFORCEMENT A:"iALYTICAL METHOD: See under Preliminary analysis. 

Deficiencies: :Konc 

VIII. PHYSICAL AI\D CHE:I'IICAL CHARACTERISTICS: ]..;0' addressed and presumahly wi Ii be 

bridged ti"om the data for the registcred product. 

IX. ADDITIO:-iAl. REVI E\VF.R'S CO.\IMEI\TS: ~(!ne 

14 

*Product ingredient source information may be entitled to confidential treatment* *Manufacturing process information may be entitled to confidential treatment*
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U.S.EPA/OPP Pesticide· Related Database Queries· NPIRS Page 1 of 2 

Home Aboul Services Meetings PPlS Stale links Subscribe Coniact 

Product Repon 

Number of Selected Prodllcts: I 

!iii Repre:'lents a link to vic\\' LSEPA!OPP Labcllmngcs (tiffform<lt). 

JJ Represents a link to additional cliemical information . 

STOLLER TEC'llNIC'AL INDOLE·3·BUTYRIC ACID 

Registration Number: 57538·27 "" fBI 

hnll J\ullJbcr: 575J.~ 

STOLLER ENTl:lU'lUSES. INC 

4001 W. SAM Hot !STON I'K IVY N. SLITE IO() 

I IOUSTON lX 77043 

71.1/461·1493 

Status: Activt,.· 

Approval Oak: 03-21-06 

Product Manager: Sheryl Reilly (703)30S-S269 

Pen.:em Active Ingrediellt 

99.000U lBA (46701)lJ 

COll(\iCl.NEU{S J~[Jl!PJ.~JI_~.UliJ(!J prml(l1:1 info <l\'aiIHl,le _thrOll!,l1I custom ;;c~lr",-lting 

01' sll.l~scripljnn 

NPIRS'ID is a rcgistl!red trmh::mark of the National Pesticide Inlomlation Retrieval SystcnL 

Copyright C 19t)8~1()06. P1mllH..' Rcseardl fOlmdation. AI! Righls Rcscn-cd. 

http://ppis.ceris.purdue.edu/htbin/prodset.com 

Fifty-fiv 

will hi 

products 

inlD 
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United 51.tot 

Environmental Protection Agency 

Washington, DC 204&0 

' Registration 

,f Amendment 

Other 

oPP Id.ntifl.t Nl/mber oEPA 

, - , I 

1. Comp~nylPfoduct Number 3, Pr~o.od Classification 

57538,27 

T; i ,; :_~_':.:~, j 

2. EPA Product M8n11qllr 

OL Shery' Reilly ,-, -, ---I r.; i None D Rlltticted 

Acid . -~.-- .. ~ 

! 5, Name .nd Addrell' of Applicent (/{1t;lud. ZIP Cod., 

Stoller Enterprises, Inc., c/o Alice Walker Consultlng 

3094 Country Club Rd. 

91 _-." _ ,-,L----~I 

6. E"pedited Rflveiw. In accordance with FIFRA Section 3Ic)(31 

IbHiI, my ptOdUCl is similar 01 Identical in composition and labeUng 

to: 

Sen,ato~i~~MISS38668 EPA Reg. No. __________ ., _______ _ 

[ j Ch6ck if this IJ tI n.w edd,.ss Product Name 

- II 

o Amendment· Explain b.,low. U Final printed lebels in foplonu to 

f ~ Aooncy l"tter deted -------------._-

_ RI!5ubmiJSlon in response 10 Ao~ncy !t,lt.r dilled ______ ~ __ 0 "M. Too' Applicllllon. 

florilielltion - E"'plein below, [J Othef· Ex-pillin below. 

I='----~---~---·- - ............... -.. -~--"==--~-~~--~-~~_____I 

Explanation: Use additienel peoe! .. ) if n~eeS$.'y. IFor see lion I end S~clion 11.1 

AmendnlOOllo add an ansfnlllO maflufaClunl19 source. 

I-rn---------------------I 

I. ,wu, ... ChHd·Rulstent PecKaging qVIII' . N. -~ 

""' Water Solubla PacKlIgifIQ r 2_ Typa of Contllintf 8 ::s 

Glen 

.~til~'''~ ~!If~·=Yc.,c-C---------7NC.-.-,-.,----+ICIfC-CYC,c.-C-------7NC.-.-,-.,--.--- P"per 

... mUll \ U~t Pack.aging wgt. conl"lnlf '1- P.lCk«oll wot , containef 'I. 

.ubmittod i i 

I 1 ~::~o 

Othe, "",0"" ________ 1 

6. Minner in Which lilbel i. Affixed to Producr L 

. C'"'~, P.io' "".,Hy, .. 

lIthogrlph 

Paper Q1ued Srancir-.d 

, ,I, 

I -IV 

, .. , 

,,' J On label 

u 0""" _~~ ____ ~~ __ 

Alice Walker, Ph.D. 

Title 

Agent 

Tel«phon. No. (lncjudD Ato. Codel 

652-562-5995 ••• :. , 

Certification : •• :.: Is, 

I certify tlull the .tolements I hev. mode on thi~ form Itnd 011 .n"htnDnt' thor,te .relrue, .ceuro~ ond Gol!lplofo_: 

I ocknowledOI Ihal Iny knowlingHy !lIIn or misl",ding liItatllment may bo punishoble by fino or fmpri.oManL ~r.... :. ~d) 

______ ~_~~~.pp~~~_~ __ lew. • -: ..... 

4. Typed Neme 

Alice Walket, Ph.D. 

£PA , ,"".3-94" 

3. TItle 

Agenl 

5. Dol .. 

June 13, 2006 

"",.-EPA ... Cop, 

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-10 ,Cop, 
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46864901 

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)lfice 'Wa(f(gr, Pfi/D. 

REGULATORY CONSUL71NG • 3094 COUNTNr CLUB ROAD· SS,\'ATUBlA, MS 38668 

J lIue 13. 2006 

Dncument Processiug Desk (Amnd) 

OPP.'BPPD (7511 P) 

CERTlFIIW MAIL 

U.S. EnviroruncntaJ Protection Agt!llCY 

1200 Pennsylvania Ave., 1\W 

Washington, DC 20460 

Ann: Or. Sheryl Reilly (PM 91) 

Re: Technical Tndolt!-3-But)Tic Acid (EPA Reg. i'Jo. 57538-27) 

Alllendment to Add an Alterllate Mllnufm::mring Source 

This lctler will constitute an amendment from Stoller Entcrpri:;(;s. luc. to add an altcl'1late 

prodllcer ofTcclmical Indolt:-3-Butyric Acid. To this cud. \\'C have generated a 5·balciI all(1Jy~is 

.. vbieb proves ullequlvocally that the proposed $otlfCC is substantially similar iu composition to 

the ft'gislercd product. 

To support this new manufacturing source, please find enclosed thc fQlJo\,\'lng data and 

doclUnentalion: 

1. Application for Pesticide Amendment form. 

2. Data Matrix, 

3. Altcrnate Cnnfidential Statemc1l1 ofFoITuulll, and 

4. 'Dlrcc (3) copies or Preliminary A.J)alysis/5~Batch A!>say, OPPl8 830.1700. 830.1750, and 

830.1800 . 

We have al!>o enelosed a copy or Stoller's most rccent fee waiver requcst. The original rcque!:it 

WI."S submitted separately 10 the Doclmlclll Processing Desk (REe,VEE) on.Ttme 9, 2006. Stoller 

ha'i been granted ]00% rec wai\!crs since PRlA \vas enacted, 

We believe the enclosed data are cousisten1 v.itb the requiremcnts for amcnded registration under 

F1FRA and would appreciate your eariie.<>t revicw. If you should bave any questions. please do 

l10t hesilate to call. 

Sincerely, 

~~[JcJL Alice Walker. Ph.D. 

Regulatory Agc11l 

Enclosurcs 

cc; Leannn Smith 

Phone 662·562~5995· Fax 662-560-5391 

Email rllice!rJUlker;.g .• epaconsll.lting.1l.et 

17 

468649-00 
• 

• 

OAKRIDGE NA1'IONAL LABORATORY 

MANAGED BY UT-BATTElLE FC~ THE DEPARTMfNT OF ENERGY 

August 30, 2006 

CUSTODY RECEIPT FOR FIFRA CONFIDENTIAL BUSINESS INFORMATION , 

TO: Pamela Landis 

Biopesticides and Pollution Prevention Divi~ion 

Office of Pesticide Programs 

U.S. Envirorunental Protection Agency 

One Potomac Yard 

2777 South Crystal Drive 

Arlin on, VA 22202 

INSTRUCTIONS, 

FROM: R. H. RoSi, Group Leader 

Toxicology and Hazard Assessment Group 

1060 Commerce Park 

Oak Ridge, Tennessee 37830 

(865) 574-7797 FAX (865) 574-5353 

email rossrh@oml.gov 

1. Original of this receipt to be signed by-recjpien~ and returned to sender. 

2. Duplicate ofthi!! receipt to be retained by recipient. 

Hours 

TASK , No. MRfDNo. Chemical! Agent WAM . Material Sent Status "'!. Actual 

0&.08& 46864901 Indole--l.Butyric Acid Landis I DllR Dmft 30 20 

1 Study 

ICD 

1 CuslOdy Sheet 

I have P,tr;s~ally reteiveO from,the sender material. encl~.lInd II.ttachmetltsas identified above. 1 assume full 

fCsponslbiltly for the safe handlm Storage, d transmittal of this ma.lcrial in accordince with existing FIFRA Confidential 

:=~··dS-; , ~ 

18 
, 

DATA PACKAGE BEAN SHEET 

Date: 01 ~Aug"2006 

Page 1 012 

'" '" '" Registration Information" ,.. '" 

Decision #: 368451 

DP #: (331567) 

Registration, ?7.538-27· STOLL§R.I.ECHNICAL IND()L~,:l·BUTYRIC A~ID ......... __ 

Company: ~~?3:B:' STOlLER ENTE'3,P,'2ISES", "IN"C,-__ 

Risk Manager: A~i!>' -:..Priss Bernnhend· (~Q?!. 308·9525 Roomll PYl S·8!!?? 

Risk Managm RoviGwar; ~~ Pfaifer JPFElt~~._ 

Sanl Dale: ___ _ Calculaled Due Dale: OS·Noy·ZO(l6 

Type 01 RegislmHon: ProtiUCI A~~_I!E!i~· Seello" 3: 

• 

Aclion Desc: t~?~)_ ~_~ENDMENT;NON:_,=-~ST TRACK;MICAOBIA~tOC'i~"M~IC~A~l~' __ _ 

Ingre<1ioots: 04670,1, l~o!e·3·butync a:!:li~~L 

'" '" '" Data Package Information'" '" .. 

Expediji,_ '< YI":S • No 

DP Ingredient ~46701 ,~ymole·3·butydc acid 

DP Tllre: 5 balch ana~y;>!s 

CSF Included: • Yes '_.' , No Labellncludoo: • Yes: No 

Dal010 

Paren1 DP H: 

Edilod Due Dale: 

Due Back. 

Drganizalion: apPD I apa 01-Aug-2000 Last Possible Science Due Dale: ~_!",,,:!_ul'2006 

Team Name: AM 91 

_OWAf Name: Alani. Wagi _ 

CommciOf Name: 

ql.A~g·2000 

OJ-Aug~~~_. 

.., .. .., Studies Sent for Review" .... 

Prinled on Page 2 

SCiollco Dve Dale: 

Sub D:lla Package Due DllIo: 

.. " .. Additional Data Package for this Decision'" .... 

No AddiJional Dma Packages 

'" .. " Data Package Instructions" ,.. .. 

PI!}.3se review 5 batch analysis 10 do1ermlne Il.cceptability 01 alterna1e source. 

19 
Page 2 

p. 

4flfW1901 (2008) Validation of Analytical Molhodology lor the Ass .. y of Indole-3-Butyrlc 830.175Oi'CtJrtilied limits 

Proccss·Relabad Significant ImpurUJes of 1ndo1e-3.Butyllc Acid and 

~~i.;.qU~,~t 5-Balch Analysis of fndole-3-Butyric Acid TGIII: Final Report Project 

Number: MKL05I0103. Unpubflshed siudy prepared by McKenzie"Wright Laboratories, 

LLC_ 419 p. 

46864901 Wligtrl, M. (2000) Validation 01 Analylklal Methodology for the Assayof indole-3-Butyrlc 830J8OO!Enlorcllmanl.analytic-aJ I 

Acid and proces$·Relaled Significant ImpuritieS of Indote-3-Bulyrit:: Acid and 

SubsoqUOr'lI5-Batch Analysis of Indole-3-Sutyrk: Ackl TGAI: Fillal Report. Project 

Numbel: MKL05/0103. Unpublished study prepaled by McKGf'lzle;Wrlght Labornlorlas. 

UC.419p . 

• 

• 

20 
Pages 21-22- *FIFRA registration data may be entitled to confidential treatment*
forlll Allpr~'v .... 1 OMit 'J<) 2117(1.0.()60 

UNITEO STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street. S.W. 

WASHfNGTON D.C. 20460 

J'aperwork Reductinn Act Notice: Thc public R:p<)rtil1g !>urden t'Or t!>is collection of inforrru.uion i:; e~timill",d to n~eragc 0.25 ht.ll,n per re~ronse tilr rt~gi51r.lliol1 aClivitles :Uld 0.25 houn; p.!r 

~1Xmsc for rCfegislwtion \Uld ~~i1l1 rc:VltW act,vilics, includin}, time for n.1uJillg the lnSlr1l1:li<)ns and ct'lllllilcting the ncce~<;;ary fonn.~. Send comments rCll.uding thc burdcn e;',(iffi1ltl.' <)runy other 

nspect or this collection of il1l~ml1aHon. including sugge~tiom I~'r ~Iucing lhe !>lIrdell to: [};rectnr, OI'I'E Infornmti<1l1 Managemenl n,yi~illil (2137). L:S, EII"ironmenwl Pruh:clkm AgC11CY, ·10 I !vI 

Strcct. S.W .. Wasbi_l'l£ton. DC 2G460. D~I nol ~1Id the I1rnn ttl this "ddrc.<;.~. 

DATA MATRIX 

Date: 6-13-06 ~:I'A Ite :oio.fFileS 'mbol: 57S:t8·27 PaRe J nf 1 

Applkant's/Rt'l!i~trHllt's Name & Addre~s: Stoller Eliterprise>, 11Ie. Product: Tuhniclll Indole.3.8utyrk Acid 

dn i\lice Walker Con~ultillg 

.Hl94 Cmmtry Club Rd. 

SenatobitL :\·IS 38668 

Inl!:redient: Indulc·3·bnt\-ric flcid 

Guideline Reference Number Guhleline- Siudy Name- ;\fRlD Numlwr SlIlrmitter Status Nute 

8J(),17()(} Preliminary f\ltajvsis I'endill" Stnller Ol~11 Footnnte I 

X.JI).175() Cenifieation ofUmit~ I'cuding Stoller OIHl Footnlll':: I 

X3tl.IIlOO :\JtlllvtiO:IlI :VlcthUll$ In Vo:rif\· ('ertifi~lt l.ili1it~ Pc-ndin Sloller 0\\11 Footnot.:: I 

• 

Footnote- I Gllhlelin~!i 831). 1711l1, 8311 1751), and K:ltL lImn arc ~atisfictl by a single ~twJy, Wnglit. M, iVld-(en/je/Wrighl 

l.aboralllrie~, LLC, Studv 1'-'0. MKLOS·OI03. 

I I 

I 

·I'cr FlFRA 31 eXII Jtf) rt'IOiremc-nt~ Stullcr prCl'iom,ly IIUlde lin ,oITer!O Ila~' thr all valid .,tudlc, >upp<.lftin!! t\-x:hnical 

IBA. includin\! ph~~icl1lichemicnl pro ,Jertie$, to :111 those I)n the mmt cnrrenl Data Submitters List 

• • •••• • • ... • •• •• .. • • • • • ... •••• 

Si .... ~?:j:'t7.:': Whl L ~ame and Titk Date-

• • • c......,...' Alice Walker, l'h.D,. Regulatory Con~ult(mt 6·13·(16 . , .. • 

I :1';\ Form N57(1·)5 (9·97) Ek<.:trOilic allli P;lp"r "cr.-;nH" ;wailahle, Suhllln '\lii1' I'apt:[ \'C~itllL 

• • 

Al:!ellcy hlternnl lise COil)' 
Aet . 

rcslWn~~' fcr tcregi~tnllil)n lind ,-pecinl review activities, 

l~,pe~t ufthis collection ofillfhfl11ation, including <' 

••• •••• •• • • • • 

• •• • • • •• 

• • • •• • 

•• 

lJNlTE() STATES ENVIRONl\'lENTAL PROTECTlO:-.i AGENCY 

,",Ol M Street,S.W. 

JX:f ro;':spunse for reghtrdtion Ilctivitie.s and 0.25 hours [ler 

time ti'lr reading the instntl;1ions and completing the m."l;e~~I/·y fonlK :-;tna C(1I11111elll, regruxling the burden esti111uto: \)f IIny other 

reducing the burden to: l)irt)ctDr. OPI'E !nfonnlltiull ~fnllagCt1);!nt OivislOn (21371. U.S_ Environmental Prol.;etion Agent,}. 4tl1 M 

FI',>\ rMIl' );570-3,5 (9-97) Ekdrun,c and Paper \'Cl'"ons ;J\lliIHbktllblllit \)1I1} p')per VC~1011 

• Al!.cney Ihternlll fst' ('<;OilY 
• 

• 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D,C, 20460 

Juuc 23, 20(16 

omcror 

I'Rf,V/:'N I l(jt\, !'prl !{·IDf:'.~ A\ lJ 

rOXlc 5UDST"l'\CES 

STOLLER E'<TERPRISES. l'<C 

400 I W. SA.M Ho\;STON I'KWY N. SUITE 100 

HOUSTON. TX 77043 

Report of Ana! ysis for Comp! 1<lIlCe witl! PH. :\Io(lte S6~5 

Thank you illr your submittal of20-JU:\l~O(), Our staff has completed a preliminary 

analysis of (hc material. TIIC result<; are provided as folll1W5: 

Your suhmittll! was ti)und «) be in full complianec with the st<mdards for suhmission of 

data colltained ill PR i'oticc 86-5. A copy of your bibliography is enclosed, annotated witl! 

\t1astcr Record JD's (MRlDs) ~lssi!:-'T1ed !O each document submitted. Please use these numbers ill 

all future references to tllcse documents. Thank you j()T your cooperation. If you have any 

questions concerning this data suhmisslon, please wise [hem \-vith tl!e cognizant Product 

Mamlger. 10 whom tlie data have heen released . 

25 
• 

• 

MEMORANDUM 

DATE: & /,:22)/(",-& _ 

TO: 1\ r'rl i \ (10 __ , Regulatory Manager 

FROM: Information Services Branch, IRSD 

Your receipt of this data submission is 

not an indication that MRIDs for the 

enclosed studies have been posted in 

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 Maureen Sherrill 

(305-5361) or Teresa Downs (305-5363). 

This is a: )o/fully accepted submission 

o partially accepted submission 

o rejected submission 

-5559553 ""po 

26 
...................... --~------

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

June21,2006 

opp Decision Number: D-368452 

EPA File Symbol or Registration Number: 57538-27 

omCEOF 

I'REVENllON, PESTICIDES A""l1 

TOXIC SlmSTA"'CES 

Product Name: STOLLER TECHNICAL lNDOLE-3-BUTYRIC ACID 

EPA Receipt Date: 20-Jun-2006 

EPA Company Number: 57538 

Company Name: STOLLER ENTERPRISES, INC 

LEANNA SMITH 

STOLLER ENTERPRISES, INC 

4001 W. SAM HOUSTON PKWY N, SUITE 100 

• HOUSTON, TX 77043 

• 

SUBJECT: Receipt of Amendment and 100% Small Business Waiver Request 

Dear Registranl: 

The Office of Pesticide ProgrdIlls has received your application for amendment and 100% 

small business waiver request. If you submitted data with this application, the results ufthe 

PRN-86-5 screen will be communicated separately. During the administrative screen. thl! Otlice 

or Pesticide Programs has dctennined 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: WOl 

ULTRA SMALL BUSINESS (100% FOR THAT COMPANY); 

Your request for waiver has been forwarded for review. You will be notified in writing 

when a detennination is made regarding your request. If the determination indicates that 

payment is due, you will receive instructions for submitting payment at that time. 

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

Ombudsman, at -(1\0 Dnla Found}. 

~ Front End Processing Staff 

Information Technology & Resources Management Division 

27 
BPPD SCREEN PACKJ,GE 

BPPD FRO'<T END: BPB/;\!PB: Team Leader: _-,jc:I-"G:LIIc:I-,'(~~ ____ _ 

Pria Code/Action Code: ___ -'~_'(-'~_'t_: ___ Tean1jRAL:_~(,,-),,-r-,IS,,-,,} ____ _ 

Product Name: -X42A\ ie:eM: 

EPA lD No,: __ S2."2.72.r)':::,~",t_, --'L:::',c:=i""' _____ _ 

Active lr.gredient(s):"',_T""LB"I1,,,'-______________ _ 

Food ___ ~~~, S b ' , .~ew u miSSion 

Non Food ReSCllomission 

• Dare In BPPD: 

Date To Screen: 

Date Ex.pected From Screen: (10 days from da:e m):~'"f--L+"===_ \VA# Oft, -/7 _'-LC~ RetHrntoBPPD: 7!zlj(u(,' 

SCREE:"! PACKAGE NOTES: 

e Pre~ Reg Meetings attached? Yes 

Submission complies with all applicable areas of checkhsts? 

IOffi1s \vhe-n returned. 

Additional Comments per Team Leader or Screener: 

SCREEN STATUS 

Administrative: ___ Fail 

Scicnti fie: ___ ,Fail 

Indicate in detail on checklists 

28 
• 

/ };J 

IFee for Servicel {795590=-

This package includes the following 

New Registration i 

L-°A __ m_e_n_d_m_e_n_t ________ ~1 

" Studies? oj • " Fee Waiver? 

volpay % Reduction:_ 

for Division 

AD 

° BPPD 

RD 

Risk Mgr. 

Receipt No. S- :=1 =7=95=5==9=0~ 

EPA File Symbol/Reg. No. :=1 ==5==7=5=38=-=27~ 

Pin-Punch Date: 1 6/20/2006 

This item is NOT subject to FFS action. 

I 

I --- I 

, 

• 

1- -----~'" 

I Action Code: "-~---

ParenVChild Decisions: 

! 

Requested: 

Granted: 13C, ';? 

Amount Due: $ CPr wt""'f)'-

i i 

I 

ReViewer:_~),-' _'L':,L::::~=' ~~) -I-~_. ____ _ 

Remarks: 

29 ................... "~----------
ATTACHMENT 1 

AdministratiVe Material Screening Checklist 

Dale: 7/24/06 

EPA Rog. No. : 57538·27 Priority code: B·67 

Active Ingredient name: ISA (Indole butyric acid) 

Division RAL assigned (if any): OriSI Benmhend 

Admin Materials Signed Date 

Yes N 

0 

CS570.1 X 6/13/06 

CSF - Completely filled out & original X 6/13/06 

signalure (EPA form 8570-4) 

inerts cleared? y 

conventional or antimicrobial y 

actives present in formulation? 

accurate information provided y 

for suppliers/source? 

CSF accurately reflects label? y 

Additional brand name listed in 

~~~ all 

Method of Support, if so state which y 11/3010 

5 

Label 

legible producl label? 

~~~ :~curateIY reflects csf? 

Physical address of manufacturer on 

label 

Data Matrix· Tw%ne for jacket one X 6/13/06 

for FOIA (EPA Form 8570·35) 

supports method of support? 

reflects information reported in 

transmittal document and 

~':.::I~Y cover letter? 

:::ulator's exemption form (EPA 

Aba Comments 

ent 

·Amendment Application is for 

adding an alternate source of AI 

-conventional AI present 

-No addilional Brand name listed 

In the CSF 

-GSF reflects Label 

Cite-all 

Yes 

Ves 

yes 

Yes 

30 
Admin Materials Signed Date Abo Comments 

en! 

Transmittal letters X 6/13/06 

accurately reflects what IS 

reported on data matrix? 

note all comments 

Petition/amended petition if food Exempt from requirement of 

tolerance or exemption/amended food tolerance for agricultural 

tolerance or exemption commodity use 

petition# assigned? 

petition jacket included? 

petition complete w'lth secflons 

A-G? 

note all comments - if there 

is not evidence of a petition 

# assigned and secl A-G not • Dreoen~ packa •• fails. 

FR template if food tolerance or 40 CFR180.1073 

exemption/amended food tolerance or 

exemption _ 

notice of filing template (disk) 

included? 

note all comments - a NOF 

must be present to establish 

a new tolerance exemption. 

Amendments to an existing 

tol. petition may be Agency 

initiated in which case a 

NOF would not expected to 

• 

be present. (If unsure, 

check with branch team 

leader) 

component in the formulation 

not cleared food use 

Certification with Respect to Citation X 

5 ,.u,u 

of Data Form (EPA Fonn 8570-34) " if 

required 

Minutes on data requirements (prereQistration meetinq<) 

Active ingredient # (i.e, Chemical PC PC Code: 046701; single active 

code) housec In BPPD 

more than one active? 

are all actives housed in 

BPPD? 

Jacket from EPA Identi~ing S~mbol 57538-27 , 

31 -- - ---
------------------.... __ . __ ._._. 

Admin Materials Signed Date AIls Comments 

ent 

Are MRIDS assigned? (State YeslNo Y 

in comments) 

Background Experimental Use Permit NA 

information, if applicab!e 

request for temporary to!, 

exempt, tal. exemption or 

numeric tolerance? 

note all comments - refor to 

petition and fr section for 

criter •. 

• 

• 

32 
----------------..... ---------.-----------. 

CHECKLIST FOR DA TA PACKAGE SCIENCE SCREEN 

Active Ingredients: lilA 

PC code: 046701 

Product Name: ISA-Technical 

EPA Reg. No/File Symbol: 57538-27 

Petition # (if applicable): 

cilelllica!, Microbial. or PIP 

,J Us\.' 

light-dmin Lepidopteran Phl'rtunone 

Only) 

\' Active !ngredielll 

,3 Rl'!(istration 

lcriutcmal Use Permit 

~ Sllblllissioll 

t3l'Dlllide I\itcrnalive 

luted Ri~k Product 

a Reqllirclllelll 

duct rdL'ntity & COlllpositiOll 

>cription oft!!e Formatioll of 

lurlljc~ 

lilnifll1ry An"l}'>!> 

tili..:d Limits 

ilrCCmClll Ana!)1ital Mcthod~ 

"iC~lJ:'{·hC1llic.1i rropcrlicl. ('l~ ",flOwn 

(t CH{ 151U91J Tah!e) 

TGAI 

B M 

Y 

N 

., 

Y 

~ 

N 

N 

Y 

Inlhrmation 

\11' FP 

Y 

Product 

y Yes. complele 

y t no MRIDi! listed 

y llwfl .' no ' i 

y 

SUbtllttled ill M R!Dli468649*O I 

y Cit!:a!1 

y 

33 
Tiel' I Tnxicit (lfno study. indicate in Comments if waiver submitted) 

lte Oral y I C;re-all 

lie Dermal y Cite-all 

lIe Inhalation Y I Cite-,ll 

• J.P., LV. Injection (Micr()bial 

,) 

nary Dennallnitation y I Cite-,ll 

nal)' Eye Irritation Y I Cite-all 

Jersensilivity y Ute-all 

I 

~ Incid~~t!; Y Cite-all 

Jotoxicity Studies (Uiothemical 

d 

llunc Rc.'>ponsc 

,uc Culture 

cwbialonly} 

day Fceding 

:.lcnemicalonly} 

un>- tJcrmaJ 

)chemicai ollly)._ 

Inhalation 

I 

toxkhy 

;)chemicaJ only) 

Tier I Non-Targer Organil,ms (lfno slndy. indicate in Comments ifwaivcr submilfcd} 

<In Acme Oral 

an Acute Dietary 

;hwater Fish LC50 

sliwatcr Invcnebmte LC50 

Hnrgct Plant .. 

1·'1 argcllnsecls 

, 

34 
crobials only) I I I I 

Othel' Swdies. r As required by product specific data rcquiremcnls(c.g. efficacy, residnes) 

• 

• 

35 
Actin Ingredients: IBA 

PC code~ 046701 

Product Name: IBA-Tcchnical 

Science Screen Comment Form 

1£1' A Reg. No/File Symbol: 57538-27 

RAL: Driss Bcnmhend 

Status: PASS 

THIS FORM DOES NOT CONTAIN CONFIDENTIAL BUSINESS INFORMATION 

Product Chemistry: 

.ta requirement is addressed by submitted studies and ciled stutiies. appears to be adequate. 

l'I'Casc- sec above li)ml. 

For details 

Toxicity: 

Data requirement is addressed by cite-all seems to be adequate. 

Nun-target Organisms! Environmental Fati.' 

Product Performlmce (Effil'1U:Y): 

Residue: 

Tolerance requirement is exempted per 40CFR 180.l 07.3 

Other non guideline or $upplemental infomtation: 

.mmentsIRecommendations: This amended application is for an addition of an 

alternllte source of AT. Preliminary analysis data is submitted in this package. 

36 

---------------------------
Pages 37-91- *FIFRA registration data may be entitled to confidential treatment*
-------------- ------ ---------, --,--.---- --~,....-----"-------

r~""" D'A Ile~ i'u"J\o D,lco1 hI .... "'.''', 

~l 57538-27 '3 -/y-{){; _7 

u.s. ENVtRONr.'IENTAL PROTECTION AGENCY 

fermol u:\ll:Imc Um:onditional 

Ofricc of Pc~tkicl\: Programs 

Bi(Jr,:~hCHks ilnd PoJ!Ul!Olr PrCW01!On Dil%wU (75! lC! 

1-'.1"" 01' Io,,""'.,k l\oJ.":I: 

121lO Pel1nsyh'i'lnI:! Awone NW 

W:L~J!lnl'lun. DC 20460 Technicallndole-3-bulyric Acid 

NOTICE OF PESTICIDE: 

1L Rcgistralion 

-- Rcregislralion 

,"",k' 1'11'11,\, .c\ ,"",dod, 

\I~,.., •• ul :\,1<1 .. " "f R~~;,"~lt( ,include Z1PC~! 

• Stoller Enterprises, Inc . 

4001 W, Silm Houston Parkway l'\orth, Suite 100 

Houston, TX 77043 

NOlC: OItl.llSCS ill labeling: differing in ,~lbl.:l.rn;<, fwm lhal "c~vl'l!Xl1U "Q!m<:i:',iun with 11m; 1l',,..i~lr.t1(Q!l mu;.t Ix: ~ubmfllcd 10 ~nd a~Ce[lloo by the 

1J!O~1iddes and Pollution i'revenl;lm DI\-i~iOll pm)(!IJ Uk (lfthe L:lbd iu COlnrn~e. In all)' "11I1C~pllhd(:tlCl": Otllhis prodUi;l al\\'ll}'~ refer \0 Ille abow 

EPt\ Icgislrntion number. 

On the 1"-1-<1< (If illfwlIIJliltfi fUIlli>h~u ll} Ih~ (cgHltJ!ll, Ihe ~oo\'e l\Jm~tl pe'II~,J<: I, lIel\'])Y 1"jii.slncdlrcr,-gl$lef;:t! IIntler lhe feuer.J.IIIISI'Clldde, I~unl'ieide "lid R,>..\ehlid<k ""{ 

Rep~lratiOlI 1$ ;11 110 W~} 10 Ix ~'''l,IIII,'(1 a, ~n cn,l"gemenll" lecumm"'I,.tui~'11 ,,], Illil pt:l.'l(l(l:;1 !ly Ihe Agenc}" III Cider 10 IIIDICCI hc:thll ~O,I!he 

~"'irolllnelll, lIIe ,\dIUi'lisH~WI, i)ll hi.:; I!MIG!I, m~Y;'1 ~lIy (1m" w'P<'ml "" qll"\'llh~ regl~II:lliOlI "r J J'I.~IIc;d~ In an:<.'ld:UII',- Will! Ihe Act The 

acccplaace of ~IIY IIJ!IIe in (\llm~~(in!l Wllh Ihe r.:gl~lr,m;m (If ~ prodw.'1 "nd~r 1111, ,-\,1 is 'Hili" he rnmhuetl ", gi~il1g Ihe fC.!1lllr.1nl :I rlglli III e.,lu,iee 

!lSI' or Ihe O~lIIe or h.l;Cl us,· if ;11i.1$ b"ell ~o\ele'l II,' ',lheK 

This registnttion does nO( eliminate the need ror continual reassessment of the pesticide. If EPA 

determines at any time, that <lddilion,1i d,lta arc required to mainwin in effect an existing registration, 

the Agency will reqllire submission of SHch data llnder section 3(c)(2)(B) of FIf'RA . 

• This product is registered in accordance with FIFRA section 3(c)(5) and is SUbjL'Ct to the following 

terms and cOlldi ti ons.: 

I. Make the follov'·'ing modification 10 your lahel before you rdcuse your product for Shipment: 

Change the EPA File Symbol to read EPA Reg:. !'J'o, 57538-27. 

2. Submit three, (3) copies of the final printed labeling bcfnrc you release the product for shipment. 

Refer to Ihc A-79 enclosufC for a fmthcr description of final printed lahcJing, 

A stamped copy of the label is enclosed for ynur recnrds, 

S'tO);ll!lc ,,( '\w",,,"v, 011.",.1 // i D~le' 

Y' .. lib ).v-i{/f£ i.-V ,-,'1.- / _ ~ 3 -/f-de 

liJ'A Icrm 1>510--6 

92 
CCEPTED 

MAR 1 921lD6 T chnical Indole-3-butyric Acid 

U:uJe':.' Ll:~ ?«hwJ l!:w",ctlcld". (IBA) f't';;~:dc?, en,;', c:<'"d"'J...4Hd:o 1'k1 Plant Growth Regulator •••• 

• • 

~:ft~;~2:;~J:~ ~v rl's:lcWQ I FOR MANUFACTURING USE ONL Y 

EPA "'D. 110. 57:BZ .;,-Z 

•••• 

• • 

• •• •••• 

• 

• 

eyes 

, If on skin or 

• ACTIVE INGREDIENT: •••• •• 

• • • 

Indo!e·3-bulyric acid ...... " ................................. , ...... , ... : •••• : 99.~,.J'·:· OTHER INGREDIENTS: .............. " ............ , .................... . " .•••• 1.0% ••• 

TOTAL 

-A •• ••••• 100.u~ • 

• • •••• • • 

KEEP OUT OF REACH OF CHILDREN •••• 

• • •••• 

WARNING 

• r eye open 

minutes. 

•••• 

• •• •• • 

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

continue rinsing eye. 

• Cal! a 

• i egg I' 

solution, or, if these arc not available, drink a large quantity of 

wnter. Avoid alcohol. 

• Call a poison control center or doctor for treatment advice 

• Do not induce vomiting unless told to do so by the poison control 

center (It doctor. 

• I I 

• I re-use. 

• Rinse exposed skin with plenly of water for 15 • 20 minutes. If 

inilation persists get medical attention. 

• I I 

• 10 

• If not btreathing, or an ambulance and give artificial 

respiration, preferably moulh·to·mouth. 

~~~~v~~~ __ 

Have the product container or labet with you when calling a poison control center or doclor, or going 

for treatment In case of emergency, call the National Pesticide Information Center at 1·800·858-

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS 

Warning: May be fatal if swallowed, inhaled or absorbed through skin. Causes substantial but 

lemporary eye injury. Do not get in eyes, on skin, or on clothing. Do not breathe dusL Wash thoroughly 

with soap and water after handling. Remove and wash contaminated clolhing before reuse. Wear the 

appropriate Personal Protective Equipment (PPE): 

• Proleclive eyewear: Goggles, Face Shield, or Safety Glasses 

• Coveralls 

93 
------------------~ ~~~~--~-~--

• 

• 

• 

• 

• 

Chemical·resistant footwear and socks 

Chemical·resistant gloves 

Dust/mist filtering respirator (MSHNNIOSH approval number prefix TC-21 C), or a NIOSH approved 

respirator with any N, R, P or HE fdler." •••••• 

ENVIRONMENTAL HAZARDS 

•••• 

• • • • • •• •• 

2 

• ••••• • Do not discharge effluent containing this product into lakes, streams, ponds, estu~ries, pcea/lS. 0(, other 

waters unless in accordance with the requirements of a National Pollutant Discharg~e:.li,"inatitM~tem 

(NPDES) permit and the permitting authority has been notified in writing prior to·di.?:harge, . • .oo not ., discharge effluent containing this product to sewer systems without previously noti')li!'l9"the locai-sewage 

treatment plant authority. For guidance, contact your State Water Board or Regi~o@7f1ce of th~ EPA. 

Do not contaminate water when disposing of equipment washwaters or rinsate. • ••••• 

•••• 

EPA Reg. No. 57538·27 

EPA Est. No. 82046·CHN·1 

NET WEIGHT 

xxxxxxxxx 

date code 

•••• 

Manufactured for •••• : 

Stoller Enterprises, Inc. 

4001 W Sam Houston Pkwy N, Ste 100 

Houston, Texas 77043 

713-461-1493 

www.keylate.com 

94 
• 

• 

DIRECTIONS FOR USE 

II is a violation of Federal law to use this product in a manner Inconsistent with its labeling. 

•••• • • •••• 

• • •• • ••• 

• 

3 

•••••• 

• •• For manufacturing use only. This product is intended only for formulatiOn Inib the!'.Wewing 

I • ••••• • 

p ant growth regulator end-use products for: • ••• • ••• 

1) Terrestrial food uses on barley (cereal grain), beans (blackeyed peas, sou~h.e!tl. peas, .Q~. Qavy, 

snap), broccoli, Brussels sprouts, cabbage, cauliflower, citrus fruits, cotton, cor(l.tfililtl, 5weet •• grain), 

cucumbers, lettuce, melons. mustard (leafy, stem crop), mustard cabbage (pak choi), oats (ceraaltgrain). 

onions (green, bulb), peanuts, peas, peppers, potatoes (white, Irish), rice, rye (cereal grain); Stlf§hum, 

soybeans, spinach, squaSh (summer, winter, zucchini), strawberries, sugar beets (sugar cr~:tlJgar 

cane (sugar crop), tomatoes, turnips, wheat (cereal grain). •• • 

2) Terrestriat non-food uses on ornamental herbaceous plants, ornamental woody shrubs and vines, 

ornamental or shade trees, golf course turf (greens, tees, fairways and rough), ornamental lawns, & turf. 

3) Uses for which US EPA has accepted the required data or citations of data that the formulator has 

submitted in support of registration. 

4) Uses for experimental purposes that are in compliance with US EPA requirements. 

Each formulator Is rosponsible for obta[nlng EPA registration for Its own end-use product(s}. 

For general product information, call StoUer Enterprises Inc. at 800·539·5283 between the hours of 9 

a.m. and 4 p.m. Central Standard Time. 

STORAGE AND DISPOSAL 

Do not contaminate water, food or feed by storage or disposal. 

PESTICIDE STORAGE: Keep containers tightly closed when not in use. Store in original container 

away from food. feed, fertilizers or other pesticides. 

PESTICIDE DISPOSAL: Wastes resulting from the use of this product must be disposed of on site or at 

an approved waste disposal facility. 

CONTAINER DISPOSAL: Completely empty bag into manufacturing equipment. Then dispose of 

empty bag in a sanitary [andfill, or by incineration, or, if allowed by State and local authorities, by 

burning, [f burned, stay out of smoke. 

WARRANTY STATEMENT 

To the fullest extent permitted by law, neither the manufacturers nor the seller make any warranty, 

expressed or implied, concerning the use of this product other than indicated on the [abel. Buyer 

assumes aU risk of use of this material when sucll use is contrary to [abel instructions. Read and follow 

the label directions carefully. 

95 
• 

• 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C 20460 

MAR 1 5 1006 OFFICE Of 

PREVENTIOtl,I'(snCIDESAI\O 

10XIC $IIBSTANCES 

ME:lcl0RA1\DUM 

SUBJECT: Review of reques[cli lJlfonnal ion suppol1ing rcgistnuiun of new soun.:e or 

[cchninJi Ind{lk~3-hutydc Hcid (LBA) (EPA Rl'£. 57538·ET) clinlaining 99.0 (i'} w/wactive 

i I1grcdicl1[, Indule-3·bu[)Tic acid (pC Code 04670 I). 

OP Barcode: 326839; DI.'Cision No. 326839. 

FROM: 

TO: 

Clara Fuentes, Ph, D., Biologis[ 

Biochemic<l1 Pesticides 13ral1cit 

Biopes[icides: &. Pollnllon PrevenIJlln Division (751IC) 

Chris Pfeirer, Regulatory Ac[ion Leader 

Biuchemical Pes[icilies lirancl! 

Bivre~tltldes & Polhulon Prevention Division (7511C) 

ACTlON ImQUESTEI) 

Stoller Enft:'7}rist!.\·, Il[c. is sllbmiHing ne\v infonnatlon requested by the Agency in fulfillment or 

requiremcll[s for registration of a new source or [cchnicallndoJe·3~bu[yrk acid (lEA) (EPA Reg. 

5753S-ET), containing 99,0 q:, wi\\' ae[i ve ingrcdiclU. lndule·3-btilyric acid (PC Code 046701). 

The product j~ a TGATJ:'vIP and a plant growth regllia[Or, chelllicrrlly identical [0 [he EPA 

registered product LT BioSyn Technie.1I3-lndulehu[yric acid (lEA) (EPA Reg. No. 72639-1), 

This L" a "Me-Too" registration, since bmh prtlduets arc subsl<lnlially sirnil<ir. 

RECOMMENI>ATlONS ANI) CONCLUSIONS 

The registrant has adclItHI[t.:ly addressed [he follmving dcficiclll'it.:s in ftllfjllmcnt of 

rCQ.istra[ion rer]1lircIllCn[s: 

/" 1"- The CAS 111lmber 011 the CSt' for the active ingredient has hee11 con"eeted" "[he correct 

, ~ CAS No for indolc<~·bu[yric add (IBA), 133-32--t. is listed on [he reviscd CSF. 

J'~' The discrepancy whether c[h;[J1ol or is used as solvent has been resolved. As 

, s[;I[ed in [lie submitled discmsion uf formation or impurities during [lie manufacturing 

proces.'>. the residual solvenls remaining in the product ;Ifler 

1101 ethanol. 

1-.,;jJP,1 f"~J-ef,', l\lhI : • nl'p :-\w,w """, ijoY 

I1cc'(Clm:IfleCrclaDI(,- .. F--+;-n .''''11 v,:"">""~ o. r"';;Ul :r_<-G~ IO~', ?D~(~(j"$V''-'-¢', P"'''~!1 C~ Olil'0 f;>u~ RUCjCiQ(: P.r.'" 

96 

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

• 

u,L3, Data for Stability, guideline 830.6313. is being addressed in the MSDS provided for the 

I lew TOAI, . Section 10: Stability and Reactivity. 

·CONTAINS CONFIDENTIAL Ilt:SINESS INFORyIATION* 

TABU; L Nominal CSF concentrations and limits ror Technical Indolc*J-Butyric Acid" 

Ingredients (CAS number) PC Code Purpose 

Concentration (% bv weiJ!ht) 

Nominal I Lower I Uppe,' 

Active Ingredient 

Indolc.-.3.butync :Kul i I 33_3]_.\)1> 046701 ACllve 99.0<.) 196..1.% IlO00k 

Impurity 

hnpllrlly I . I i· 

" , Dala from CSF. 

TABLE 2. Physical .md Chcmital rrnpt'rtie; fllr l'l'i:IUlkill Inth)It-J.Bulyric Add ~ 

,;uldcline Uer('rence Xn. Pro n'rh' Dl'licri )lion t1r Ikorull J\.fv\l»>tls 

830.6302 C.,lm \\11ill' 

S30.6303 Physic,,] SIJle Solid 

830.63o.t OJor I'\cgli/1lh1c 

830.6313 Slal.uhly :\ddU"~~C'u in MSDS ],or 1\01 

rc(jlllrrd for MI'. 

S:m631..j O:<.iualnmfRC'uu<:I)Ou: hiCOmp;l\lble '*11]) strong ll:<.idi/l'f' 

Chellllc;ll IllcOI))N!<hilitv 

830.6315 1'1<llnlll:;hlllly NI:\ 

830.631(1 Explod<:lhlhlY ;-i!A 

8:\0,(,317 ShJlJgc SI:lblhly Sl<:lhlc <:II ;1mlm:nt Ic.-mpcralurc 

830,6319 /I.'II!>(;lhl!ily Insoluble ill W:1IC'r. ~Olllbl<: II) o]rohol. 

:1(;cIOll<: 

S3U.fl32n \.'orrosloln Cha.rac:lc.-n~lin 1:;.;.//\ 

I 

8306i2t Dld.'clnc Bl'c.)kJowll Vollage :;';'01 f()f usc in or a.rotillU c.-Ic.-cincnl c.-llUipll1(,UI 

830.1000 rll ,:\'0\ wlublc in wah.'f 

I I 

97 

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

• 

3 

TAHt..£ 2. l)by!\if~11 nnd Chemicilll'ropcrlh'S for Techlliod Indull'-3-nlllyrk Acid a 

Guideline Refel'l!nl'e ~u. t'nl Nil' Dt'M'rinHoll of H~ult "ldhods 

R3U.7100 Vi;C()siIY N/,\ 

830.72DO ~lcn1flj,! R;I1I)!1,' Nul H"llllIed fOl TGr\\ or MP 

830.7220 BnlllIIg R;lflgC ;':01 rcqum:d lor TO,\ I or MP 

S31J 7300 Blilk Den"ll' 6:U; Ihitl! 

8]0.7:)70 Dl~!>1.J(iatll)1I C(lU,ta11l m Wall;r ;0;111 kqUlred lell TG,\\ ur MP 

8311.7.')50 P;u-l1Iion CUCfliClcl11 1"01 required I .... r '1'0,\1 or MP 

830.7S.tO \V;Uc( Solublhly Not ~ql1ired for TOAI Qf Ml' 

830.7950 V;lpl)r Plc\~mc I\'O[ rcqulf<'d lor TOAI or MP 

-

nACKGROU~D AND REVIEWER COMMEI-ITS 

This is an nppJicalion \0 register:1 nc"·;, somet! ofTedmicallndolc-3-Bmyric Add (lB;\), a 

TGAIIMP for milnufacturing usc only to be used as pl:lnl growth regulator. The actiYe ingredient 

is 99.0% w/w indole-3-butYlic acid <lnd the impurity is . This. is a 

"me-too" since the product is substantinlly similar to currcntly registered MP, (EPA No. 72639-

I), which contains 98(1;(. lBA. The label is consistent with the CSF concerning the active 

ingredient. The description of staning materinls and production process \vere addressed 

adequately. In the 5-batch ISA preliminary analysis results, the Hvemge content of IBA and 

moistlJre were 99.08±O.82% ilnd respectively. The cel1iJ'ied limits 1'01' IBA were 

set at 06,4-100% on the CSF, which arc \'/ilhin the recommended range in guideline OPPTS 

830.1750 and in agreemcnt with the prclimin:u)J analysis. The enforcement method is an HPLCl;'V/VIS method wilh Ittdolc-3-acctic acid (lAA) ll..'i Ihe internal stimdaru. The precision of the 

analytical instrument was 0.0312% and the accuracy of the IlnillylJcill method was 100.52% with 

a slighl positive bias 01'0.436%. The physicnl and <.:hemical charactcristies were obtained by the 

"eilc-all" method from EPA fornt 8570-36 and are adequately addressed. The stability datu 

required ror registration or this new TG;\I is pro\,ided in the MSDS for 

98 

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

• 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D,C, 2046(} 

MEMORAN!)UM 

MAR 02 2008 

SUBJECT: Review of Product Chemistry Studies, MRIDs 46708301, 46708302 and 

46708303, supporting registration of new source of technical Indole-3-butyric acid (lBA) (EPA 

Reg, 57538-ET) containing 99,0 % wlw netive ingredient, lndole-3-butyric acid (PC Code 

046701), 

!)P Barcode: 326839, !)ecision No. 326839, 

FROM: 

THROUGH: 

Clara Fuentes, Ph.D., Biologist 

Biochemical Pesticides Branch 

Biopcsricides & Pollution Prevention Division (7511 C) 

/'~) , 

Russell Jones, Senior Biologist / / /; 

Biochemical Pesticides Branch :,./ «-~(-

Biopeslicidcs & Pollution Prevention Division (7511C) 

TO: Chris Pfeifer, Regulatory Attion Leader 

Biochemical Pesticides Bronch 

Biopestiddes & Pollution Prevention Division (751IC) 

ACTION REQUESTE!) 

Stoller E1IIerprises. /tIC, is submitting copies of the CSF, summary of physical-chemical 

properties (Description of the Production Process, MRID 46708302; Discussion of Formation of 

Impurities, MRID 46708301; and Validation of Analyrical Methods. MRID 46708303) and draft 

label for registration of a new source of technical Illdole-3-butyric acid (IBA) (EPA Reg. 57538-

ET), containing 99.0 % w/w active ingredient, Indole-3-butyric acid (pC Code 046701). The 

product is a TGAIIMP and a plant growth regulator, chemically identical to the EPA registered 

product LT BioS),n Technical3-lndolebutyric add (IDA) (EPA Reg. No. 72639-1). This is li. 

"Me_Too" registration. since both products are substantially similar. 

RECOMMEl\'DA nONS AN!) CONCLUSIONS 

The submitted product chemistry data are unacceptable but upgradcable. To upgrade the 

studies, the registrant needs to address the following denciencics: 

~he CAS number 011 the CSF for the active ingredient is incorrectly given us 525-79-1, 

The correct CAS No for indole-3-but)'Tic acid (IBA) is 133-32-4. 

Intomol Addrou tURL) • hllplhWIW.opa_90V 

fffcycilldlfl.cyebhhi. PMtoo wth v~ Oll a-d!nM en A~ Pap« (Minimum Z>% PQ&lCOOWIMr) 99 
"'~Olve the discrepancy whether ethanol or is'used as ,olvent. As stated in 

"'\- ~ MRLD 46708302. , not ethanol, is used l.]s/~olvcnt in the manufacluJing process. '\.. .r1, Data for Stnbility, guideline 830.6313. is not being addressed. This data are required for 

'\\ registration of a TGAl. </ 

• 

• 

~)t The MSDS of nceds to be provided.! 

NOTEloRAL 

Change signal word CAUTION to WARNING as slaled on referenced product label, 

EPA No. 72639·1, containing 98.0 % of the same active ingredient. 

Address first aid and precautionary statements for oral exposure as indicated on label of 

referenccu product EPA No. 72639~ 1. containing 98.0 {7v of the same active ingredient. 

STUDY SUMMARY 

PRODUCT CHEYllSTRY 

PmdUCI chemistry and composition: 

Deficiencies: 111t! CAS !\o. of the lIeli ve ingrcdicnt is incotTcct on the CSF. Thc 

chcmic:llidentity or as shoulu be put on the CSF. 

Description or starting m<ltcrials. production and fannulation process: 

Deficieneh .. 's: The MSDS of is not provided. 

Discussion or rOl:mation of impurilies: 

Deficiencies: The registrant needs to resolve the discrepancy whcthcrethnnol nr

is uscu as Illc solvent. The CSF needs to give the identity or the . 

Preliminary analysis: 

Deficiencies: None 

Ccnified limits: 

Deficiencies: Nonc. 

100 

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

• 

J 

'CONTAINS CONFIDENTIAL BUSINESS INFORMATION' 

TABLE I. Nomina) CSF concentrations and limits for Tt'Chnical IndoJc~3-nutyrjc Acid~ 

Concentration (% b wei.ht) Ingredients (CAS lIumber) PC Code I>urposc Nominal I Lower Upper 

Active Ingredient 

hHlok-3-billyric acid (133-32-4)b 046701 ACI!\'(' 99.0',{: I <J6 ... V'f> 10(}',1-

Impurity 

" Data from esp. 

II Incorrectly given ;IS 525-79-1 on the CSF 

Enforccmcllt <ll1illvtical mClhod: 

Deticiellcies! None .. 

Phvsical and chenlical characreristics: 

Deficiencies: Dal>! for OPPTS 830.63! 3 (Guidcli ne, \vhich is ncccssM)' to register TGAI.) 

arc nceded, 

TADLE2 . I'hysical and CJlcmknll'rope!1ics fur Tt-'thllIClil Indoll,-).nulyric Add ~ 

Guiddine Refen'olX' N(I. ProPl'rlV Ocserlltiun of Res nil Mcthods 

830.6302 Color \Vhlll' 

830.6:t03 PhYMcal Slalr Solid 

830.63(}"s Odor :\egllglblc 

830.b313 SI~b!luy I :\01 ;«hlr<,s.~ed for TGA I: Nol requile-u lill 

\W 

8:1O-6JI-I OXldj,lwnfRcduclion: IIIC;)mp~ljblc will! ~lm!lg oxidl7.ers 

Chrm!rldIlKl\!lU1;:llilllll . 

830.6315 Flo!!!OIalllllly N//'I 

fBO.6316 E"pluu~bllj!} ~JA 

8JO.6317 Slorage Slnh!luy Slablc ~l amblcOllempCr>llllfC 

830,6319 r-,'lbclbilIIY hl~!)luh!,:. In W>llcf. ~ulllbk ill ~koh,\1. 

oc.:ll1l1e 

830.6320 ('nn 1).1.1(,,) Cbaraclefl~ljc; 1'"..;/'>\ 

101 
• 

• 

4 

TABLE 2. Physielll aud t.:htlltirl.lll'ropertil'S ror Tee!lllkallndole-J-Dutyric Add" 

Guidl'linc Itl'ferenee No. Proprrlv l)c;<;eriplilln or Result M4:1hods 

8)0.6321 Dldttlrit: Breakdowo Voltage Nol fm use In or around dcclriC:l.I eqUIpment 

830.7000 pH NUl soluble in ",'liter 

830.7100 Visco~ily NIi\ 

830.7200 i-kltlllg Rllll~l' SII\ rctjollcu rorTGAI or MP 

S3ttn2o ilOllillg Range :-,'0\ re-quln:u for TGAI or f',.'IP 

830.7300 Bulk Di:\l~lly 65.15 IblCt' 

s30,71iU DI~wci;l1ioll Constant In Waler :'\()\ n~qlllrtd for TG,\I or MP 

830.7550 P;n\liinn Cnenh~leol :-':0\ f('qnircu for TOt\ I Ul' MP 

830.7840 \Valer Solubility NO! reqUIred fur lO/\1 Uf MP 

830,7950 Vllpor P~S5Ur!.' Nol r~"\lllll'ed for TGAI or MP 

, " " " DJll Ohlnlllt'd Ill' lile elle-all method from EPA \()I'ln 8510·.)6. " 

BACKGROUNIl ANIl REVIEWER COMMENTS 

This is an ~rp!ication to register u new source of Technical Tndole-3-Butyrie Acid (IBA), a 

TGAIIMP for manufacturing use only to be used as plant growth regulator. The acti\'c ingredienl 

is 99.0% w/w indole-3-butyric acid and the impurity is w/w . This is a 

"me-too" since the product is substantially similar to currently registered MP, (EPA No. 72639-

1), which contains 98% lBA. The label is consistent with the CSF concerning the active 

ingredient. The dcscliption of starting materials and production process were addressed 

adequately, except the MSDS of was not provided. In the 5-batch lBA preliminary 

analysis results, Ihe average content of lEA and were 99.08±O.82% and 

respectively. The certified limits for IDA were set 11I 96.4-100% on the CSF. which are \vithin 

the recommended range in guideline OPPTS 830.1750 and ill agreement with the preliminrny 

analysis. The ellforcement method is an HPLC-UV/VJS method Wil!l indole-3-acelic acid OAf\} 

,IS the internal sHmdarJ. The precision of the ;millytica! instrument was 0.0312% and the 

accuracy orthe :malyticaJ method was 100.52% with a slight positive bias 0[0.436%. The 

physical and chemical characteri:Hics were obtained by the "cite-all" method from EPA form 

8570-36 and are adequatcly addressed with the exception of OPPTS 830.6313 stability to 

elevated temperatures, metals, and mew!s ions. 

NQTEto RAt 

Ch,mge signal word CALffJON to WARNING as stated on referenced product label, EPA 

No. 72639-1, containing 98.0 % of the same active ingreuient, and address first aid and 

102 

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

• 

5 

precautionary statements for oral roule of exposure <IS stated 011 label or referenced product, 

EPA No, 72639a 1. containing a lower concentration of same active ingredient, 98% Indolea3~ 

butyric acid . 

103 
• 

II/lernal BBPD Gllium/cc DocI/mcllt· Other Items Mav be He/mired RAL: Chris Pfeifer 

OLD ACTIVE INGREI}IENT 

NEW PRODUCT REGISTR-\T10N/EXISTING PRODUCT AMENDMENT CHECKLIST 

EPA File Symbol/Reg. No.: 5753S-ET (27) Applica!ion Date: 11/3015 

If 3mendment. indicate type: label. CSF or both: RegisJmtion 

If amendment. is change covered hy PH. Notic!.! 98· I () (Notil1l:atiolls)? YESD NOD NA 0 

If Yes. STOP. Ca!J applicant and inli.1rm them that this submission will be converted to a notification. 

I, Application Form (EPA Form 8570·1) signed and <:amplete illcluding package. YES 0 NO 0 NA 0' 

la. r;lst-Track: YESDN00 

2. Hllal printed 1:lbdill!; received i"or bbds tlpproved aner 1011199? YES 0 NO 0 NA 0" 

If NO, Stop! E·mail app!i'::;l1lt and requc~t fin:.!! printed labeling (FPL). Letthenl know 111011 fPL flOm the last accepted 

label i~ needed 10 supporl Ihe \'IJm:m applic;nion, Fik \'O!»' of yOU! e·mai! ;]). rcc.wd of 1l0Iifica1ion. Log out of PRATS (label 

defio.:icncy). Exceplions \() Illis pr;K'IlCc '::JllllCCllL 

3, Confiq~mial St:lkmellt of FOrl1!.ul'! (EPA form 8570-.1) 

a) Completely filled Ollt inciudh Ig pH, fiashpoinl. flammability, etc. if applicable. 

b) Totals are ;JCClInJtC. 

c) Certified lilllitii agree with 40 CFR 158.175 or 5 batch :JlJalysiii. 

d) PC codes il:)sigued 011 ('SF for inel1s ;lOr.! 40 CFR 180.1001 e, d. or codes noted for producls 

that ilave food or feed tlSes. 

c) List I ine/1 ingredient presellt? 

YES 0 NO D 

YES 0NOD 

),E50 NO D 

YES0NOD 

YESDN00 

e f) Alternate fOrnl1tla(s) do not l"I!4uirc differellt labeling fWlllothcr formulas'! 

g) CSF is sigued and dated. 

YES fil NO 0 

YES 0NO D 

h) Registereu source for a.i.. 

4. Data Matrix (EPA For1l1857(h15l :ll1d Duta 

a) Using selective method? (If NO, data matrix nOI required. skip to i!(:1ll5.) 

I) Complete data matrix. Minimmn data mtltrix for registration would iuc!ude produtt specific 

acute !oxicology and protlutt chemistry data and eflicm.:y for public heahh pests, Minor CSF 

and labeling amendmellts may nOI require a uat;1 matrix. 

b) Adequate produ<:t specific dat;l. 

c) Registered SOllrce llscd for a.i .. If YES, a,i. is from a registered source illld generic data 

should be satisfied by registered sOllrce. skip (0 item4. If NO. generic data needed. 

YESDN00 

YES 0NOD 

YES0NOD 

YES 0 NOD 

YES0NOD 

I) Adequate gcnaic data YES 0 NO DNA 0 

104 
d) Data passed 86·5 (Data Fonnalling PR ;-"'otice)? YES 1i1 NO 0 

c) Public copy ofntatrix present. as required by PR Notice c)S-5(Comllell~ationn YES 0" NO 0 

5. Certification with Respect to Citation of Data YES 0" NO 0 

(EPA Form 8570-34) (Sec 40CFR 152.80-98 ami PR Notice 9:-:l·5) If no data are required or 

submitted. the Certification need not be submitted. This is often tOle for minor 'ImendllleIllS. 

Il) Did applicant check il method of support? YES 0 NO 0 

b) General Offer to Pay t:hecked for citc-all method or cilc-il11 oplion under sdecthe method. YES 121 >JO 0 

c) Is the form Signed and dated'! YES 0 NO 0 

d) Cheek form and data matrix. Are exclusive use data cited from other sources'? YES 0 NO It] 

1) If YES. is required muliorizLlIion leuer present? YES oNO 0 i\A 1i1 

6. E<)[!n),!.lators Exemption FOnJJ (EPA Form 8570·27) fifled out and signed ifllSing a registered 

source active ingredient in the formulation. 

YESONOONA0 

7. Exclusive US.iliQtiee Requirement Priqr to Registration (Required per 40 CFRI52. I 16. sepamtc from 

permission of an exclusive use data submitter to rely on exclusive use data) 

Is tltis au exclusive use aj. or combinntion of active ingredients (registered within last 10 years)? 

If YES. go to a) or b) below. 

<I) Has a notification letter or email been senl to tlte exclusive use data sllbnutter(s) allea.<:t 3D 

days before regislration'! (TIlis notification is required for all methods of data support except 

when the exclusive lise data snbmiller(~r product is used to formulate and the fomlUfator's 

exemption is claimed.) 

I. Has exclusive use data submitter requested during Jtl day pen(xi the applicants' list of 

dala requirements and method of eOlllpliam::e? 

b) Has registrant submitted certification from exclusive lISe d.l!i1 submitter that submitter is aware 

of application and does 110t object to the rcgLmation'? 

s. L'lbel(s) 

.1) Lnbel(s) agree with current Label Review Manual and apllropriatc REDS. 

b) AcUIe toxlwlogy, product chemi.my. and efficacy data examined for lahcling. 

c) Nominal concentration of a,!. listed in ingredients statcmcnt 

d) Storage and disposal iustructions Ilgrcc with container IYIICS !i sted on applicati<m fonn 

c) Unique Producl Name for Same Company fCheck REFS) 

o Libeling is acceptable, Corrections or changes are l'\OT necessary? 

YES 0 N00 

YES 0 NO 0 

YES 0 ;\00 

YES 0 NO 0 

YES 0 NO 0 

YES0NOO 

YES0NOO 

YES0NOO 

YES 0KO 0 

YES0NOO 

g) Bob TO£ln Concurrence for OMRI Logo. YES ONO 0 NA 0 

2 105 

• 

• 
• 

• 

BASIC CHECK LIST FOR 

CONFIDENTIAL STATEMENT OF FORMULAS (CSF) 

Please note that if you have ~Iny questions at Clny point, cspeci<tlly with chemica! or microbiul names, 

consult with a chemist! product churactcrization scientist. (Frcshteh. Paul, Russ, Carl, Michael T. W. 

or Chris). It may be hc1pflll to make a copy of the CSF for marking comments, questions, and needed 

corrections. Upon completion orIhi:> form, consult the above scientists. And have them check IlVCf 

the ('SF along with your comments. 

EPA Rcg#1 File Symbol: 51538·21 CSF dated: 11/30/5 REVIEW DUE DATE: 311416 

I. Compare CSF with plior eSF(s). and dctemline what is different. 

Kates: NA 

1. Examine lube!. Does tilis product have food or feed use sites'! No 

3. Is each field filled Ollt on ('SF? 0 yes: no 

::Ylissing: NA. 

4. Is box 18 signed? 0 yes no 

5. Arc addresses complete. including zijXodcs in boxes l, 2, and It? 0yes I: no 

Deficiencies: 

6. Have they enclosed u Material Suicty Datu Sheet CvlSDS) for eaeh new ingredient'! 

o yes lino 

Detlciencies: NA. MSDS alrcudy on file. 

Please Jlote thm witCH die PPCV S)'SJelII is/ItJJctio!li)Jg ogain most ofthi,l' ill/ormariollfor 7·12 can 

be obtaiJled oJJ-lille. Smllt' ilf tbe codes 11/0)' be 1i.~JeJ Oil prior CSFs ill prodllct jacker . 

7. In colUmn 10. for each component is the chemical namc, trade name .md CAS No. listed'! Is it 

clear what each component is? (May need til consult Farm Chern Handbook, Chemicnl Caralogs, or 

olher refcrences of Zubkoff or Toghrol) 

For any microbial ingredient, in column 10 - tlie description should include Colony forming units per 

gram (CPU/g) and cell collection identity number (E.g. ATCC 889·34.) 

o yes no 

Deficiencies: NA. Everything is acenunleu fUL 

8. Using a chemical catalog, or Refs verify the CAS #, and chemical nnme for each component under 

consideration. Also Note any toxicological information disclosed in cut<llog. 

Deficiencies: NA. CAS#s are correct. 

9. Determine PC codes for each component :md write these in "EPA USE ONLY" column. Docs 

each component have PC Code? (Notebooks with PC cudes me in File room. REFS lists PC codes 

for Active ingn:uienL".) If codc(s) are not found, it illay he necessary to send request form to Linda 

fan 

PC C<ldes are written in column. 

106 
10. For each inert component determine whether it is listed under 40 CFR 180.1001 (c)(d) (e), And 

write these codes in "EPA USE ONLY" column. (Name.'> may be conrusing~ consult with a chemist ir 

needed) fIlMs product is /or/eed or food use, all illert ingredients MUST Jrm,'c appropriate 

clearance. 

Deficiencies: NA. However, all ingredients arc cleared for food/feed use. 

II. For each inclt component that docs not have (c)(d) or (c) clearance determine whether i1 is a list 1, 

2,3. 4(a) ,Of 4(b) inel1. Write this infolTIlation in"EPA USE O:-.JLY" column. Rererences to 

consult www.epa.govJopprdOOl1inertsandI.RVol.63.No. 121 pages 343S4-34390. If any of Ihe 

inert il1grcdicllls are listed as "No loager used" in the above FR vo!.63 notice, or are Oil list I or 2. this 

is a problem to bring attention to chemist 

Problem incrts? NA. Hnwever. inerts arc cleared. 

12. If product used on food or feed, confirm aeti ve ingrediellt(s) has <1n established tQlenmee or 

exemption from food tolerance. (Consult Alphabctieallbting in pmt 180 of 40 CFR pages 296-300, or 

the pesticide petition file jacket) 0yes Dno Deficiencies: All cleared. 

13. Do certified limits fur EACH eompnnent agree wilh 40 CFR ISS.175? 

.Amotinnn'<:~~lpl)jn 1" 1> .. l'reSCriti<i<!ilill1fts U '"'L··· ~w~iJAmit:;:;' . , ppe',.!mtl • • 

51% N ± lOo/cN Nx 1.1 N .... 0.9 

>1% but $20% N±5%N Nx 1.05 N x 0.95 

>20% N + 3t

loN Nx 1.03 N x 0.97 

- N;::; amount 10 Column 13 h.:::; nommal concentratIOn 

Calculate upper and lower limits using table above and compare \vith those listed 

in columns 14 a. and 14 b. of submitted CSr. If the), do nol agree, identify differcnce(s); Every 

calculation is wilhin the limits. However, Ihe lower limit for is not aRplicable. a<; is 

• 

considered an impurity in thjs formulation. tit 

14. Does the sum of the numhcrs in column 13. a. equnl tOiallistcu in hox 17? 

0' yes '=110 

15 Does column 13. b. add up 10 100'l(:'1 It'! yes: --no 

16. If Alternative Formulation box is checked in box A~ Is there another CSF for a Basic 

Formulation on file?? :":'yes ::::no 0' NA 

17. Other issues? NA 

107 

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

• 

File Symbol: 57538·ET 

[SiteIUsa] 

Tox CalegOries: W=waived 

Label Requirement 

Restricted Use Pesticide 

Product Name 

Compny Name and Info 

Identification Numbors 

Net Conlents 

Ingredients Statement 

Labe! Claims 

Alternate Formula 

Label Review 

Date: 3/10/6 Reviewer: Chris pfeifer 

I Res lAg IBolh ] [Food !Non-Food IBolh ] 

[AcOral: W JAcOerm: W IAclnhl: W IEyelrr: 2 fSkinJrr; W DarmSens: Nol 

AcceplDbla Nol AcceplfJble NJA Comments LRM3 

Recommendations 

....... _ .. .......... . .. - Ch6 

~ Pg 12·3 

, Pg 15·1 

, Ch14 

, Ch17 

, Ch 5 

, Pgs 4-5, 5·7 

11·10&Ch12 

" 5·12 

PrecauUonary Statements 

label Requirement Acceplable No. NlA Comments LRM3 

AceeplabJe Recommendations 

KOROC , 3·1 & 9 

7·3 &4 

Signal Word , Changed Ch3Ch7 

Ch to 

General Heading , Added Statements Ch 7 

'PRECAUTtONARY 

STATEMENTS' 

First Aid (PAN 20001·1) " Added Hollins box Ch 3& 7 

Hazards to Humans , Added sl:.llcrntntS Ch 3, 7-3 

and Domestic Animals 

PPE (WPS) , Ch 7,Pg 7·t2 

Engineering Controls Pgs 10·4, 15 

User Safety \' Ch 10 

Requiremenls 

User Safety , Ch10 

Recommendations 

Environmental Hazards , Minor edit Ch 8 

Physical and Chemical , Pg 3-4 

Hazards Ch9 

108 
Directions for USE (FIFRA T.x~ WPS plus Storage and Disposal 

Label Requirement Acceptable Nol NlA Comments LRM3 

Acceptab!e Recommendations 

Header 'Directions lor 1 10-16 

Use' 

Violation 01 Federal law , 10-16, ))·7 

Ie" 

WPS Text , Added PPE in H'l7.;lrds Ch 10.7-1 

(prE) SUllcmcnt 7-11 

Non·WPS Text , 7-12. Ch 10 

Storage and Disposal ,I 11-16.Ch13 

Directions for Use (General Instructions and Information) 

Label Requirement Acceptable NOl NfA Comments LRl\t3 

Acceptable Recommendations 

Gonerallnstruc!lons and , • 

Sub-Header 

Chemigalion I Prohibition , PRN 

REI , Pg ttl-::!O 

Label Requirement Acceptable Nol NfA Comments LRM3 

Aeceplllble Recommendations 

Gonorallnfo. (r;:,m-sde , 

",,!!ellic <010 on \I~e$> pes!!!, 

ml~ln9, ~r.d loading, lank mixing. 

~IG.) 

General Precautions and , 

Restrictions • 

Directions for Use 

Directions for Application ,; 

WalTaniylnfonnaUon 

Consis!ency wilh Iabol ,I 12"6 

instructions 

Not lalse or misleading , '~I11C warranty scction contains an IIverly broad statement concerning limitations oflinbility, As such, this 

statement may be misleading and may constilUte llIisbrallding under the Fedemllns('cticid(', Fungicide nlld 

Rodenticide Act (F1FRA), It is sugg('$1ed that the existing statcmeut be prl'ceded by the phrll5e, ~to the extent 

allowable by state law", orothetwise qualified to make it ciearthat this warranty is not intended to bl:' a 

st1tement of law which implies that the buyer has no Icgal rights to l-ecover damages from the manufacturer if 

be/she suffcred n loss or injury from the product and concludes that it would be futl!e to pmslIe what ntight in 

reality be a "aHd claim," 

109 
ROUTING &: l'R,\NSMITT \L SLIP " , , M h arc 16 2006 

TO, (:-';am~.omc.: symbol, loom nllmbtr. bllliding. Inilial$ )ale ( 

AJ(ocy;p(lsl) I~t\/ " liv (cif ( Linda Hollis / 

2, SherI'! Rcill . I • '4---- ') ",<:id;J 

3, Junet Andersen l.-j ">1/ '3Y7n1"" 

4, Chris Pfeifer ;1 

r( -, 1/ 

5, 

Aelm" FM N,)\~ Ami Rd!llil 

,', Appro~'al , For ('I~ardIlr.: I\:r Ccn\"o,;'n>~ li()o 

As 1(0: ucsled For COfrC>.'1ion I"re=R~ I' 

Cu\'u1ak Fur Yourlnfmm;uilill SCCy!e 

i,·. ' Cum!Tl<:nl .". -,., liWCSIJ ale , 51 'nalure 

I, ' COo:lrdiU31iou JlIslify • IlIiti~I;.Cono,;'lIlTcncc 

• l\IARKS 

Subject: 

SlOlIer En1erprises. Inc .. Technic,d Indolc.3-!Julync Acid 

EPA Rcgislralilln Number 57538-13'1' (27) 

:-'1e-loo Applic!l.lion from 72639-1 

AppliClIl'hm Dated 11/30/5 

The label and CSF required very few changes. TIlt: registrant nlHde ul! lhc 

'-H\lj1rovemei1ls asked Qflhem. 

"i_:;'closcd are: 

! I·] mpics of the Registriltion Kotice (1 for concurrence) 

2) L+lhcls: Highlighted, Fillnl and Substantially Similaf 

"'\it':SF 

.iJ'-Rc"icws: LJpgradenble 10 Acceptabl¢ 

• Clwcklisls: Old AI. CSF mld [)(hel 

i\uminislntlivc pllpcrwnrk am.! Lhe j~cket are attached. 

Chris Pfeifer 

foPA npPD 

:, ' 

j: 

.i, , 

- j : 

Room N".·1l1tlt. 

9!OW23 

Phone No 

703-308-003 ! 

110 
&EPA Environmental Protection Agency 

Wil~!lington. DC 20460 

OMS No. 

,/1 Registration 

_, Amendment 

_.-l0ther 

I lor ,- II 

: OFF idanrifl.f Number 

I 

!'S753S'tu "{7 __ ,_ 

3. PlllpolHKl Cilluific"tion 

t,~,,~~~"~N.m;o" :;-~U""jC_AC;::.id ____ , PM. 

PM91 

----.j ;.f! NOM ~ RllIlrietad 

____ ---...ll_·-----.-----1 

S Nemt and A<ldtllu 01 Applic<U1' !lnc/",I .. ZIP Cud;'i 

Stoller Enterprises. Inc. 4001 W. Sam Houston 

Parkway N" Sulle 100. Houston, TX 77043 

6. Expedited Reveiw. Irl accOIdaflCe with FIFRA SeeJio" 31(;113) 

, lb!lil. my product is Similar or identical in compositiOf) 300 labeling 

':~A Reg. NO.~ and 72639-1 

! Name ~e B~ Acid Technical 

, - II 

~ Am~ndme"t· "><plai" bQJow. ; i F'n .. 1 printmlINu<ll~ ,n r"'P~onu to 

:~ Agonc\, !1I"ut d<ltoo ~ ___ ,, __ _ 

_, Rosubml$-$'o!'\ to ro,p005~ 10 Allftni:\, I~tter dilled ;.f "Mil Too" Applic<!l!,on. 

I NQI,j,eut!!)I'I' Explo.," bolow Dth~, E>oplotn lM!ow. I E·~··~···.~')~;;;ii,on ;V:,:.~":'~'~";:io~'" P"\l~J5J d 'mc~~::-,,-. -,-'o-,-.-"-cr:~~-·',-.-,"-,-,-,-,-"-",C,-,,C;O·- --<--

Ch,jd-Rui"t~nt I>ntk~llj"l1 

, L Yes 

,,f No I . 

'C.""lfk' •• ,,~ mvst 

submitttKI 

I Un,t :<!Ickolg.ng 

,f I Y"s 

I } ~~~~o_ --,,--------- -No-.- V.' 

, Uni! Peck30,no w';It conlainer 

I 

-III 

,.-

j WoItM Soluble ?acka\1"'O 

i ~z1 ::~ 1_ _ __________ --,-. ___ ,. 

Ii ·V,s" No. p"r 

Pack,,';I" wQI cO'-'l.!Ijn~r 

, 

. Locotion o! Not Cont"nts Inlorm"t,on 

.. L 

j 4. Sm.isl -R,,-;;;;C;;-;'t~;;'.r 

.J~.- lltb .. t ______ I _ COnr"jM~ ______ _ H:<J 1()I'g I' 

6 Manne' ,n Wr.cr. leb~!,~ A!t,~ed tIJ Product I" , , ! OthM 

, - , 

, . -IV 

11. C{lnt(lct POint !ColTlpf.nf' ,/#ms dirf'clly !III/OW lar iu-mtiliclI!'on 01 tnd;1I{dua/ to bll cOIl/acl .. d. if 1--- - ., -. , .-.-.. -C'-

Nemn : ,itlo 

l):;n C·Sj1a\!gj1r~essy. Ph 0 _ O .... Sf 

--------

I 

'0' , J afJixed !aool 

, -~---

, 

, -

Cenifica1ion •••••• 6_ Oat/l ..yrp~o.tiOI't 

! cetlity rhat th" ~~otllment'J i l1a". m!lde on tl>.is forlll lInd 1111 il!tachmllnl! tha'''IO a'lI trull. accuroto and C~I"~. :: R"l.-:v.~ 

I acknow!edo" thllt any k"'-'''''!''-'Oll'l iaJ$e '" mi~!o.winQ slatumon! rna-v be p'uni~hl'lb!1I by filUl Of imp,i~onmlln.'V •••• ! • ii&atTtpedl 

bllih under Ipplicablft Illw. • • I----·-C.: . 

: ::.~£%Jit/""~~.-:7J' __________ +1 :;::"::>0'~"-'o'''/w'·-' -_---- ----.- .--

D O'Shaug!Y19SSi ' 

i 

••• •• • • 

••••• 

••• • •• •• 

• 

. •••• . •••• 

• ••• 

• •• •• • 

111 
• 

• 

dee 

D. O'Shaughnessy Consulting, Inc. 

November 30, 2005 

Ms. Sheryl Reilly 

US EPA. Biochemical Pesticides Branch (7511C) 

clo Document Processing Desk 

Crystal Mall #2, Rm. 266A (APPL) 

1601 Bell SI. 

Arlington, VA 22202 

Dear Ms. Reilly, 

RE: Application 10 register "me-too' Te<::hnicallndole~3-butyric Acid on behalf of Stoller 

Enterprises, Inc. (Co. No. 57538) 

Enclosed please find an application and supporting documents to register a source of technical 

indole-3-butyric acid, using the ~cite·aU" method of support This product is manufactured by 

lianyungang eCA Chemical Co. (EPA Est. No. 82045-CHN-1) . 

A compJete listing of the attached data and other documents is found in the accompanying 

Transmittal Document. In short, this includes the application and ancillary forms, appropriate 

chemical data to support the composition of the product as 'substantialfy similar" to currenUy 

registered products, and documentation of the cile-all method of data support. 

Please note that Stoller Enterprises has recently been identified as e~gible for fee waiver as a 

~SmaU Business~ under PRIA, and documentation of this is also attached. 

I trust the submission is correctly fonnatted and assembled, and the cite-aU method of suppoprt 

should simplify EPA's review_ However, if I can expeditiously correct any possible deficiencies, 

please contact me at 973-726-4533 or by email aldoconslt@earthtink.nel. 

End: see transmittal document 

Sincerely 

Don O'Shaughnessy 

;~1 Birch Parkw<.ly Sparta N,J 07.'37' 

10:>:'0:73 nG41;::f, 

112 

467083.()O 
• 

• 

TRANSMITTAL DOCUMENT 

1. Name and Address of Submitter 

Stoller Enterprises, Inc., Company Number 57538 c/o O. O'Shaughnessy Consulting 

Inc.,21 Birch Parkway, Sparta. NJ 07871 

2. Regulatory Action in Support of Which This Package is Submitted 

3. 

4 . 

48708301 

48708302 

Applicalk>n 10 Register new source 01 technical indole-3·butyric acid 

Transmittal Date 

Novemebr 30. 2005 

Ust of Submitted Materials 

Volume 1. 

- AdministraUve materials: EPA Forms, Data Matrix and data compensation 

inlormation «Form 8750·34, copies of oUeHo-pay leiters), CSF, summary 01 

physical-chemical properties, draft labeling, PRfA lee waiver information, 

Volume2. 

Description 01 Production Process (3 copies) 

Volume 3 

• Discussion of Formation ollmpurnies (3 copies) 

Volume 4 46708303 . Preliminary Analysis,l5 Batch Assay, McKenzre I Wright laboratories Study 

No. MKL04-0124 

Transmitted by', Don O'Shaughnessy, Ph.D" DABT, DABFM, President, D.O.C. fnc., 

Agenllor Stoller Enterprises, Inc. 

Contact Information: lei. 973-726-4533 

lax 973-726-4155 

email doconsll@earthlink.net 

address 2t Birch Parkway, Sparta, NJ 07871 

113 
• 

• 

"Don O'Sllaughnossy" 

<doconsll@earlhlink.net> 

03/15!2006 10:53 AM 

To Chris Pfeifer/DC/USEPNUS@EPA 

cc 

bee 

Subject Ro: 57538·ET 

History: q. This message has been fOlVlurded. 

Thanks fur all the action. 

The product name Sh01dd be "Technicallndole.3-blltyric Acid. The 8570~ I box 4 an be 

corrected hy adding a" J j' between Stoller and Technit.:al in keeping with the heading of that box 

i.e. "Company f Product (Name)" 

The registra1ion c.kx.'1lmcl1ts shmJid come to me. I will keep copies: roc my files and send on to 

Stoller . 

1 attach u fomlul COITcclion with regard 10 the 

The "Summary of the PhysicaV Chcmicul Properties" fonn lists all the "Group B" info1111<1lion as 

"ci1e all" including ~6317 storage stability. None arc spccific;Jlly accounted for in the d;lla matrix 

because the "CTTE ALL" in 1he matrix meallS all, except those data whit::h arc em, such as tht.! 

actual product characterization. synthesis etc. It has hcen. so long as I have been doiltg me-too 

regislrations, u:)u,ti prnctit::e to cite the physicaV chemical d~lta so long a:) the analytical chemistry 

shows the product to Ix sufficiently similar to those for which the data have been submi1tcd The 

offcr~lo~p;ly letters includc all data pertinent 10 a tedmicaV manufacturing lISe produc1, and do 

not limit the offer to exclude chemistry data. (The ouly Jimita1ion is to exclude data on cnd·use 

fonnulalions which arc not pCllinent to a technical product.) The information can be readily 

found in the other l11anllfaeturcrs MSDSs, Product SpeCifications. or technicallitcmlltre. 

[";''1 [..;., 

COffededP4dl~cimpur 

~ pdf corflXtcnflole.pdi ~ 

On M'lr 14, 2006, at 6: 19 PM. Pfcifcr.Chris@epamaii.cpa,gov \\Tote; 

Hi DOll. 

A few more ilems~ 

Regarding papcrwork: Upon compiclioTl, whcrc wOllid you want this mailed? 

Your application ha.<; it going directly to Stoller, .mention to your 

name. Would YOlI prefer that it goes to your mailing address so that you 

can then send il to Stoller? Or .should it got to the attention of 

SOll1eOnC in panicul<lr at 1he Stoller office? 

Secondly, the rcviewcr appreciates Ihe amended 880.1400. However. could 

you also email a simple sWtement t01he effect that the mention of 

ethan])1 was a mistake in the original submission. and that was 

the acting solvent all along, 

114 

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

• 

d(])c , 

D. O'Shaughnessy Consulting, Inc. 

March 16, 2006 

Mr. Chris Pfeifer 

us EPA, Biochemical Pesticides Branch {7511C} 

cio Document Processing Desk 

Crystal Mall #2. Rm. 266A (APPl) 

1801 S Bell SI. 

Arlington, VA 22202 

Dear Mr. Pfeifer, 

RE: Finalization of application for Stoller Enterprises "Technicallndole-3~butyric Acid" 

File symbol 57538·ET 

Enclosed are various modifications and corrections per our discussions on this 

application We very much appreciate your hard work and diligance on this action. 

Enclosures include: 

• M •• ified dleftlebeliilg (5copieej $_f t.r 4m';/ p.u ,.~-to Corrected Discussion of Formation of Impurities (3 cop"les) 

Modified CSF - addition of with CAS# (2 copies) 

- MSDS for (1 copy) 

Sincerely, 

Don O'Shaughnessy, Ph.D., D T, DABFM 

President 

Agent for Stoller 

2j n"u, P3{\';i',,-,Y SrWf!8 NJ 01"81>1 

L)X ii'!:,--'(;'[; -11 55 

o 0 

o 0 0 

•••• 

o 

o 0 

•••••• 

o 

••• • o 0 

.. 

o 

•••• o 0 

•••• 

•••• o 0 0 

.. 0 

115 

•••••• 

o 0 0 

o 0 

•••••• o 0 

.. • •••• o 0 

••••• 

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

• 

dq,c 

0, O'Shaughnessy Consulting, Inc, 

Mr. Chris Pfeifer 

US EPA, BPPD (7511C) 

Crystal Mall # 2 Rm 266A 

1801 $. Bell SIArlington. VA 22202 

Dear Mr. Pfeifer, 

March 15, 2006 

RE: Correction of error, Technical !ndole~3-butyric Acid application by StoUer 

Enterprises: 

REPORT TITLE: Discussion of Formation of ImpUrities, Technical Indole-3-buryric Acid, 

DATA REQUIREMENT OPPTS 680,1400 (40 CFR 158,167) 

In the application dated Nov. 30, 2005 for the subject product, the subject report 

contained an error of transcription on page 4 of 4. Specifically, the original Report 

induded "ethanol" as a possible residual solvent, wilen in fact only is used in the 

process. This has been verified by direct communication with the manufacturing plant in 

China. 

Accordingly, a corrected page 4 is herewith attached. 

PhCfll' 973.726.4533 

Sincerely, 

Don O·Shaughnessy, Ph.D., DABT, DABFM 

President 

Agent for Stoller Enterprises 

21 Birch Pr:fW,,>'Jy, $;).,l1a, NJ 07$71 

~.)X 973,726·4155 

• • · ., •••• 

• 

• • •••• •• 

• 

••• • 

• • 

•• 

• 

•••• 

• • •••• 

•••• • •• •• • 

116 

• ••••• 

• •• 

• • 

• ••••• 

• • •• 

• •••• 

• • 

••••• 

*Manufacturing process information may be entitled to confidential treatment*
Pages 117-129-*FIFRA registration data may be entitled to confidential treatment*
• 

• 

flOG 

D. O'Shaughnessy Consulting, Inc. 

Mr. Chris Pfeifer 

US EPA. SPPD (7511C) 

Crystal Mall # 2 Rm 266A 

1801 S. Sell SL 

Arlington, VA 22202 

Dear Me Pfeifer, 

March 15, 2006 

RE: Correction of error. Technlcallndole-3·bulyric Acid application by Stoller 

Enterprises: 

REPORT TITLE: Discussion of Formation of Impurities, Technical Indole~3~bulyrjc Acid . 

DATA REQUIREMENT OPPTS 880.1400 (40 CFR 158.167) 

In the application dated Nov. 30, 2005 for the subject product, the subject report 

contained an error of transcription on page 4 of 4. Specifically, the original Report 

included "ethanolH as a possible residual solvent, when in fact only is used in the 

process. This has been verified by direct communication with the manufac1uling plant in 

China. 

Accordingly, a corrected page 4 is herewith allached. 

Phont<: 97:1·726··1533 

Sincerely, 

Don O'Shaughnessy, Ph.D., DABT, DA8FM 

President 

Agent for Stoller Enterprises 

218,(t:il P:IfKW<lY, Sparla NJ 07871 

i<lJd?j3·72G·4155 

130 

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

• 

6 

Discussion of Formation of Impurities 

Product: Indole-3-bulyric Acid, manufactured for Stoller Enterprises, EPA Co. 

No. 57538 

A production process is described in a separate document with this application. 

Theoretical impurities include reaction by-products or degradation products, 

carried-over impurities from the input materials, and possible reaction products of 

these. 

Similarly, traces residual solvent may remain in the product after 

crystallization. 

The 5-batch analysis (submitted as a separate volume) demonstrates that the 

product is highly consistently in the range of 98.74 to 100%, with 

comprising all the remainder. Volatile organic solvents might potenlially be 

included in the remainder but are of non-detectable quantities. 

Therefore, regardless of any theoretical impurities, none remain in the product as 

manufactured . 

131 

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

STATE:'>IE!"T OF GOOD LABORATORY PRACTICE COMPLIA!"CE 

The descriptive Inform;1.tion in this repon is not sU!1iccr to the requirements of 40 CFR 

Pan 160. 

Author: 

D.o-Shaughnessy 

D.O.C., Inc. 

Sponsor/Submitter: 

D. O'Shaughnessy 

President 

D.O.C.,lnc., 

Agent for Stoller Enterprises, Inc. 

Signature: 

Date: 

Signature: 

Date: 

• 

• 

132 
• 

• 

STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS 

No claim of confidentiality is made for any information contained in this report on 

the basis of its falling within the scope of FIFRA § 10(d)(1)(A), (B) or (C), 

Company: Stoller Enterprises, Inc. 

Company Agent: D, O'Shaughnessy, Ph,D, DABT, DABFM 

Title: President, D,O.C. Inc" Agent for Stoler Enterprises, Inc .. 

Signature: Date: ________ _ 

133 
" 

• Administrative 

. .. Materials-~-

• 

, 

.-------

134 
I 

i 

• 

• 

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

REPORT TITLE 

Application to register Stoller Technicallndole-3-bulyric Acid 

Administrative Materials. 

DATA REQUIREMENT 

NIA 

AUTHOR 

NIA 

COMPLETION DATE 

NOVEMBER 30,2005 

FACILITY 

NIA 

SPONSOR 

StoUer Enterprises, Inc. 

4001 W. Sam Houston Pkwy N., Suite 100 

Houston, TX 77043 

SUBMITTER 

D. O'Shaughnessy Consulting, Inc., 

21 Birch Parkway, Sparta, NJ 07871 

VOLUME 1 OF 4 

Page 1 of 2 

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135 
Contents 

1. Application Form 

2. PRIA fee wiaver fonn 

3. Confidential Statement of Fonnula, 2 copies 

4. Summary of physical I chemical properties 

5. Data Matrix with footnotes and copies of offer-ta-pay letters 

6. Certification with Respect to Citation of Data 

7. Draft labeling 

• 

Page 2 of2 

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136 
• 

FEE FOR SERVICE 

• 

137 
DATA PACKAGE BEAN SHEET 

Date: 14-Feb-2006 

Paga 1 013 

... * '" Registration Information"" * 

Registration: §7S38-ET - STQ_LL~8_rECHNlCA~.J!!IP9LE-3-BUIYRtc;"ACID 

Company: 5753.? - STOLLER ENTERPR_I_~§_S._ INC 

Rmk Manager; AM 91 -linda Hollis· (103) 308-e7~_~?Olmi CM·2 9tO"'f6.1 __ 

Rmk MMagor Revlower; Jay Pleikn JPFE!FER 

Sen! Dale: Calcula!rld Due Dala: 05-t.1~y·2006 

Typo} 01 Registration: Producl Re!:!l_$!~aJ_l_~n • Section 3 

Action Dase: (867) NEW PRq9uCT;~9N.FAST TRACKJ'iICRgBIALIBIOCHE~!S::Al; __ 

--

• • " " Data Package Information" " .. 

Expedlie: ;') Yes. No Dale Sen1: !4·Fob·2000 

DP Ingrooionl: 046701, indol,,·3·bu!y1!c acid 

DP TIlle: Product Chern 

CSF !ncludG<t • Vas '. No labollncluclnd: • Yes Paren! DP it: 

ASS)Q!1edTo __ _ Dalcln Date Out 

Decision #: 363126 

DP #: (326839) 

Ed,led Due DaleDuo Back: 

(){ganlzation: BPPD I BPe 

Team Name: RM 91 

last Possible Sciern:e Due DiI!e: 06.Jan-2006 

r,'/~,,·h-~} ,--{,~.~, 

IiJ/aviewer Name: iIonel!!~~~~~~_: __ 

Wtractof Name: 

Sc,(mC(l Dua Date; 

14-Feb-2006 Sub Data Package Due Data: 

• * • Studies Sent for Review" ... 

Printed on Page 2 

.. * • Additional Data Package for this Decision" * * 

Prin100 on Page 3 

,. * * Data Package Instructions" .. * 

Determine if prodUCI Qualilies as a subslantmUy similar mgistralicn. 

,-

\ , 

\ 

138 

/ 

___ I I 
OP,'r (326839) 

MRID" I: 

Page 2 

••• Studies Sent for Review' •• 

"Clla:ion Rtiflifi;Jp"t:: " ,', < -; ; :;-,:, f' ' Doclsion#: (363t26) 

<GuIdOIino':< '«>,,':1 

.t670830 t O'Shoughnossy, D. (2005) Description of tho Production Procoss and Inputs, Techncial 880, t 200IDoscriplion 01 SUlrting fT 

Indolc-3-8utyriC Acid ('IBA'), UnpublisMd §wdy prepared by D. O'Shaughnessy 

Coosultlng, Inc. 39 p. 

4fl708302 O'Shaughnossy, D. (2005) DiSCUSSiOn 01 FormaliOfl of Impurities Tachnical 880. t400fOiscussion of formation 

Indolo·3·Qulyric Acid. Unpublished sfudy prepnmd by D. O'Shallghnossy Consulting. 

Inc, 4 p. 

45708303 Wright, M, (2005) Validation of tho Analytical Methodology for the Assay 01 830.1700,'Prcliminary analysis 

Indole·3-Bulyric Acid llnd Process-Related Signilicant Impurill0\3 of Il1dolo-3-Bulyric 

Acid and Subsoquont 5-Balch Analysis of tndole-3·Butyrlc Acid TGAI: Final Report. 

PrOjoct Number: MKL04JO t24. UnpuOliS\I("<1 sludy ploparcd by McKenzlONJrighl 

Laboratories, LLC. 36t p. 

467013303 WrlghL M, (2005) Validation 01 the Analytk:al Mslhodology tor tho Assay 01 1330. t 7SO/Certified limits 

Indole-3·Butync Acid and Process-Relatoo Significant Impurities of Indole-3-Blltync 

Acid and Subsequent 5·8atch Analysis 01 Indole·3·Butyric Acid TGAI: Finol Report. 

Projecl Number: f.1KL04fO t24. Unpublished study prepared by McKonzlo .......... right 

laboratories, LLC. 361 p. 

46708303 Wrighl, M, (2005) Validalion oltha Analytical Methodology for tho A5Say of 830. tSOOfEnlorcoment analytical I 

Indole·3.Butyric Acid and PrccMs·Rolated Signillcant Impurities of Indole·3·Butyric 

Acid and Subsequenl 5-Batch Anatysis 01Indole·3·Butyric Acid TGAI: Flnat Report. 

Profect Number: MKL04fQ t24, Unpublished study prepared by ~lcKenzlu!Wright 

laboratorios, LLC. 361 p . 

• 

• 

139 -------------------------
DATA PACKAGE BEAN SHEET 

Date: 04-Janw2006 

Page' 012 

* * * Registration Information • ~ • 

Registration: 57538-ET - _~TQ~_I:-ER TECHJ.~IC~L INDOL_I;_~~_-BUTYRIc::_AGJO 

Company: 5753_~ __ :_~TOLLER ENTEA~_~ISE~. !NC 

Risk Managor: AM 91 • linda Hollis - (703) 300·8733 Aoomlr CM·2 910W61 

h Manager Reviewor: Ja" _~I~!!!:lLJPFEIFER 

Son! Dale: Culculu/cd Due- Data: 2?_·Apr-2006 

Type of Aeg,stfntion: Product Rogi$tru~n - ~~lion 3 

Action Desc: @_?!LNEW PRODl!g~!:Ng_~.FAST TAAC::IS.~~o!!.9AOBIALlB!oc.!:i-E~!_CAl, 

• *' ,.. * Data Package Information· • * 

DP Title: Production ~~~~~- Product Chemistry_ 

CSF Includoo: ' '-::: YO(l • No l<lbol Included: ("' Yes • No Parent OP II: 

Assigned To Dille 10 Dille Out 

Decision #: 363126 

DP #: (325115) 

Edi!od Due Da!e: 

Duo Back: 

OlganilUliOIl: BPPO .r_~!:,~_ 

Toam Name: AM91 

04·Jan·2006 Last Possible Sciellce DUB Dato: 28·Doc-2005 

""lIewer Name: BC9um'_f>l~_srifl_ 

mC\or Name05-Jall-2006 

*' .... Studies Sent for Review" .... 

Pdntoo on Page 2 

Scl&flCG Dua Dale; 

Sub Dam Package Dlle Date: 

*' *' • Addrtional Data Package for this Decision >I- -l- * 

No AdditiOllal Data Packages 

*' ~ • Data Package Instructions * * .. 

Ravie'll producl ChemIstry Is product $ubs!antially similar, 

~ .. 140 
Pilgtl2 

(325115) ••• StudlN Sent for Review" • Docisionll: (363126) 

liD I " , ";,<' ' ,;,OOIi!i<iiiJliiffl,li!i<iiii:,,'" :'I',,::,< :;elY ;g"::,liJili,'Gtildlil.h"""'1 

\30 I O'Shaughnessy, 0, (20(5) OescrlpliOfl 01 lhe Prcduclion Procoss and Inpuls, T0ct1nclal 860. I 200/0escrlpilon of starting IT 

Indolor3,Butyric Acid ('IBA'). Unpublished sludy prepared by D. O'Shaughnc55Y 

Consu1ling, frw. 39 p. 

1302 O'Shaughnessy, O. (2005) OiS(:ussion of FormatiOn 01 Impuritios: TechnICal 

Intlollr3-butyric ACict Unpublished study propared by 0, O'Shaughnessy Consul/ing. 

Inc. "p_ 

lit. 8303 Wrighl, M. (200S) ValidaHon 01 the AnalyliC<lI M&lhodology for tho Assay of 

Indole·3-Bulyric Acid and Process-Related SigniHcani Impurities o! Indole-3-Bulyric 

Acid aod SubsGquGnt 5-Balch Amllysls 01 Indcle-3-8utyrk; ACid TGAI: Final Roport. 

Pro;oct Number: MKl04i0124, UnpubliShed study propared by McKenzleM'riohl 

LrtborBtOfi!)S, LLC 361 p. 

46708303 WrigJtf, tA, (2005) Validalion 01 the Analytical MOlhodology lor It ... Assay 01 

Indoh?-3-Buryric Ack:! and Process-Relalad Signi/icanl Impurities 01 Indolo·3·Buryric 

Acid and Subsoquonl 5-Balch Analysis of IndOle-3-BlJtyrk: Acid TGAI: Final Report. 

Project Number: MKL041l)124, Unpublislled study proparcd by /;\cKcnzie.Wrighl 

laboratories, LLC. 361 p. 

46708303 Wright, M. (2005) ValfdllJlon 01 Ihe Analytical Melhodology lor Ihe Assay 01 

Indolo-3-ButyriC Acid and Process-Ralalad S[Qnillcanl Impurlllos 01IndoIG-3·Butyric 

Acid and Subsequenl 5-Batch Analysis of Indol",,3-Butyric Acid TGAI: Finnl Report 

Projecl Number: MKl0410124. UnpHblishiid study prepared by McKenzleNJrlght 

LaOOr:l.1orios.llC, 361 p 

• 

• 

a80.I 400iDiscussion of formation 

830.1700fPreliminary analysis 

83O.175OfCerlifled liml1s 

83O.laOOJEnlorcementllMlyticllll 

141 
• 

• 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTO~, D,C. 20460 

M~;MORANDUM 

MAR I) 2 2006 

SUBJECT: Review 01 Prodllei Chemisiry SlUdies. MRIDs 46708301, 46708302 and 

46708303. supporting registration of new source of technicallndole~3-bulyric acid (IBA) (EPA 

Reg. 57538-ET) containing 99.0 % w/w active ingredient, Indolc-3-butync acid (pC Code 

046701). 

DP Btncodc: 326839; Decision No. 326.839. -~.--~ rz- (~ ---~ FROM: 

13iuchemical 

Ci<lra Fuentes, 

Pesticides 

Ph.D., illologist 

Branch 

~~ ~ 

Biopeslicidcs & Pollution Prevention Divisinn (7511C) 

THROUGH: Russell Jones. Senior Biologist 

Biochemical Peslicides Brallch 

Biopcsticitles & Pollution Prevention Di vision (7511C) 

TO: Chris Pfeirer, Rcgu!alory Action Leader 

Biochemical Pesticides Branch 

iliopeslicidcs & Pollutioll Prcvelltion Division (751 I C) 

ACTION REQUESTED 

Stoller EllfCIlJrises, fnc. is submitting copies or the csr, summary of physical~chemical 

properties (Descriptioll or the Production Process, MRID 46708302; Disclission of Formation of 

Impurities, MRID 46708301; and V:llidJlion or Analytical Methods. MRID 46708303) nnd draft 

lubel for registration of 11 new source of tcehnical Indol.e~3~butyrie acid (lI3A) (EPA Reg, 57538~ 

ET), cont<lining Y9J) (If.y w/w active ingn:dicnl, tuuok·3-bulyric ucid (PC Code 04670 I). The 

product is a TGAlfMP and a plnnt growth rcgLlI:ltor, chemie;llly identical to the EPA rcgislered 

product LT BioSyn TeehnicuI3~lndolebutyrit: acid (lEA) (EPA Reg. No. 72639-1). This is 11 

"Me~Too" registr<llion, since both products arc 5ubst,mtiu!Jy similar. 

RECOMMENDATIONS /\ND CONCLUSIONS 

The submitted product chemistry datil lire unacceptable but upgradcublc. To 1I pgrade the 

studies, the registrant needs to address the roliowillg dcficiencie..'i: 

1. The CAS number all the CSF for Ihe active ingredient is incotTecily given as 525~79~1. 

The correct CAS No for indolc~3-butyric acid (IBA) is I33-32~4, 

InlNl'lol Addross {UAl). hnp:lt.vww.OPQ,gov 

R.cyel&<UR.cy~l.bI •• Pr1Illml wkh V(I(}(\lllbkl OM Bllood l"k$ en fttcycktd Papel (Mlnknum 25% P<nlCOf1$UIfl!Ifj 142 
• 

• 

2, The chellliC<lI iucntity of " " shDuld he stated on the CSF. 

3, Resolve the discJ'cp:.mcy whether ethanol or is used as solvcnt. As sll.l.teu in 

MRID 46708302, , not cth;mol, is u$cd as solvent in the manufacturing process. 

4. Data for Stahility, guideline 830.6313, is not being addressed. This data is required for 

registwtion of a TGAI. 

5. The MSDS of needs to be provided. 

NOTE 10 RAL 

6. Change signal word CAlJTION to WARNING as stated on referenced product labcl, 

EPA No, 72639·1, colltaining 98.0 % of the same active ingredient. 

7. Address first aid and precautionary statements fur oral exposure ,IS indicated on label uf 

referenced product EPA No. 72639-1, containing 98.0 % of the S<lme tlctive ingredient. 

STUDY SUMMAI{Y 

PRODUCT CHEM1STR Y 

Product chemistry '!..f1iLcomposition: 

Deficiencies: The CAS No. of the aCtive ingredient is incorrect on the CSF. The 

chemic<llidentity of " " as should be put on the CSF. 

DescrijltiOll of s~arting materials, production and formulation process: 

Deficiencies: Thc MSDS of is lIot provided. 

Discussion of formatiOl'Lo( illlplllities: 

J)cficicncie.'i: The registrant needs to resolve lhe discrepancy whether ethanol or 

is 1lSCd as the solvent. The csr nceds to give the identity of thc . 

Prelinlinaryanalysis: 

Deficiencies: None 

Certified limits: 

Deficiencies: None. 

143 

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

• 

*CONTAINS CONFIDENTIAL BUSINESS INFORMATlON* 

TABLE 1. Nominal ('SF concentrations and limits for 'l'echnicallndole~3~Butyric AcidA 

Concentration (% b \VelebO 

Ingredients (CAS number) PC Code Purpose Nominal I Lower Upper 

Active Ing\"cdictlt 

Indole-3-bu!yric ndd (!:n -32-4)" (}]()701 Actin: 99.0'k 1 96.

4% 100% 

Impurity 

Impurity I -

" - a Data from C51'. 

IJ Incorrectly given <IX 525-79-1 on the CSf 

Enforcement analytical method: 

Deficiencies! NOlie. 

Physical and chemical characlcllitics: 

Deficiencies! Dma for OPPTS 830.6313 (Guideline, which is necessary to register TGAL) 

m'e needed . 

T,' ULE 2. Ph)'sk.al ~ntl CItt'lllicnll'To]lcrlit'!i for Technlc1l11mloh~.3.lIUlytlc Add 3 

Gultlt'!hw Uefl't-")lC1' No. rro }Crl v Descri \lon of R~·.sull Me!hods 

830.6301 CulM While 

-- 830.6]{/j I'hym:<l1 Sllile Solid 

830.630.1 Odnr Nfgligiblc 

830.6313 Sl;l!Jllu}' Not :l(ldrcsseo for TGAI; NOllequired for 

MP 

8]0.6314 I h id:llion/l(cdm:tion: IncOlnp;!llhk willi ,Irong nxidi7er~ 

Chenticnl ]ncomnalihllit,' 

830.6315 FIJUIIIUhllll~' !NfA 

830.6316 E~]!lo,-J:\bilily N/A 

830,6317 Slomgc Slabllily Slahll' ~l :ullbicm IClllper;.tlurc 

144 

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

• 

4 

M31J.{,319 Miscibility flJ50iul)le in wllter .. \oluble in alcohol. 

acetone 

RJIH\..12U C(}rm.,iClIl Characlcrislics NIA 

830.6321 Dielectric Breakdown Voltage NOl for usc in ur around efecll'ical equipmenl 

830.7000 pH NOl50iuhic in water 

830.1£00 Viscosity NIA 

830.7200 ~leflillg Rllnge NOI required forTGA! or MP 

830.7220 Boiling Runge Not required fnrTGAf or MP 

830.7300 llulk Density 65.S [hlllj 

830.7370 DL~ocilltion Cnn.,t:ml in W.ller Nol required CotTGAI or MP 

830.7550 Partition Coefficient Not requited for TGAI or MP 

830.1'840 W:\(er Solubilj(y NOll'cquired for 1'0,\1 or MI' 

830.79:50 Vllpor Prc~snrc Not required for TOA I or MP 

• Om" Oh\;ltnW by the "U[e-l1l1" method rrom EPA form 8570·36. 

BACKGROUND AND REVIEWER COIVL'\1ENTS 

This is an application to register a new source ofTechnicallndolc-3-Butylic Acid (IDA), a 

TGA1IMP for manuf;lcturing lise only to be used as plant growth regulator. The active ingredient 

is 99.0% w/w indole-3-butyric acid and the impurity is w/w . This is a 

"me-too" since the product is substantiaJJy similar to cun"cntly registered MP, (EPA No. 72639-

I). which contains 98% IDA. The label is consistent with the CSF concerning the active 

ingredient. The description of starting materials and production process were addressed 

adequately, except thc MSDS of was 1I0t providcd. In the 5-bateh IBA preliminary 

analysis results, the average (.:ontent of IDA and were 99.08±O.82% and

respectively. The certificd limits for IBA were scI at 96.4-100% on thc CSF. wllich are within 

thc recommcndcd rangc in guideline OPPTS 830.1750 and in agreement \\,ith the preliminary 

analysis. The enforcement method is an HPLC-UV/VIS mcthod with indole-3-acetic acid (IAA) 

as thc internal standard. The precision of the analytical instrument was 0.03 J 2% and the 

accuracy of the analytical mcthod was 100.52% with a slight positivc bias of 0.436%. The 

physical and chemical charl1cteristks were obtained by the "cite~a1J" mcthod from EPA form 

8570-36 and are adequately addressed with the cxception of OPPTS 830.6313 stability to 

elevated temperaturcs, mctals, i1nd mctals ions. 

NQn:toRAL 

Chrulgc !iignal word CAlffJON to WARNlNG as stated on referenced product label, EPA 

No. 72639-1, containing 98.0 % of the same active ingrcdient. and addrcss first aid and 

145 
.. 

• 

• 

5 

precautionary statements for oral route of exposure as stated on label or referenced product, 

EPA No. 726~9~1, containing a lower concentration of same active ingredient, 98% Jndole~3~ 

butyric acid . 

146 
• 

• 

-- ~~"II' !l~,'1 t~v ,~",....,.~ I I ~ 1.1,(,r t.~IC,:. 

c.'j'~1 Cd '111<',;' ""~ 1"',1 

1~,let"J:IC' 1>,110-,':11 I'" ~'''',:H C, I Of' 

,~tC,,...JI,¢r, ::.r.t,1I e,,, .. ,~, 

SEPA 

ADlv1]}.ns TRATIVE N O( S). : 

P11: ql --------------------------------

CHE~lICAL ~O.: ---------

The jacket for this action can be 

requested through the JACKETS system. 

147 
ATTACHMENT 1 

Administrative Material S<:reening Checklist 

001.:12129105 

EPA Reg. No. : 57538-ET ; Priority code: B-67 

Active Ingredient name: ISA (Indole-3-Butyric aCid) 

Division RAL assigned (il any): Andy Brycolond 

. -~-.-~-

Admin Materials Signed 

". 

X 

I 

.Im 8570-1 

: 

: 

• 

- rn

-

--- -----. 

I Date 

I 

: 

I 

~~.~~---~~~~-.-. 

Abae 

nt 

Comments 

11/30/0 

I 

-Application (me-IOO) is for a 

5 new source of Techhii::allBA 

i 

/ ,---

(for arrend,use preduc!) 

- modilted·CSF submitted • - No !nerts, one non-active ! ,, __ ·····_~~~.I""~~'--~;_~~_I~~_~ __ ingredient is 

CSF - Completely filled out & original 

signature (EPA form 8570-4) 

• inerts cleared? 

• conventional or antimicrobial 

actives present in tormu!alion? 

accurate information provided 

for suppliers/source? 

• 

• 

• 

csf accurately reflects label? 

Additional brand name listed in 

CSF 

,.""-~--,n"o,,te,,-~R_~Q_I!1_'!Ients 

.. 

X 

Y 

Y 

Y 

Y 

y 

y 

i 11/3010 

5 

listed as manufacturing 

impurities 

• Conventional AI present 

-No additional Brand name 

listed in the CSF 

. CSF reflecls label 

....... ~.--II--If-------

-"""""---

y 

y 

I 

! 

11/30/0 

5 

. .. ~~~~-.. 

148 ... ~ ... ~~~~~~~~-~~~- *Manufacturing process information may be entitled to confidential treatment*
".--- --~~-.----~ ---------

AdminM aterials 

-

Formula 

form 85 

tor's exemption form {EPA 

70-27) 

Transmi ttalletters 

ccurately reflects what is • a 

r eported on data matrix? 

• n ote all comments - ----------. _._------

amended petition if food 

-----

Petition! 

tolerance 

toleranc 

or exemption/amended food 

e or exemption 

• p etition# assigned? 

• p etition jacket included? • ~ etition complete with sections 

*G? 

• n ate all comments - if there is 

n 

• 

_E 

ot evidence of a petition # 

ssigned and sect. A-G not 

resent. oockaae falls. 

FA temp late if food tolerance or 

exemptio 

exemptio 

nlamended food tolerance or 

n 

• n olice of filing template (disk) 

in eluded? 

ote all comments· a NOF • n 

m ust be present to establish 

• 

new tolerance exemption . • 

Am endments to an existing 

to 

In 

I. petition may be Agency 

IllRled In which case a NOF 

w 

p 

w 

ould not expected to be 

resent. (If unsure, check 

ith branch team leader) 

• c omponent in the formulation 

n o~J~jJred food use 

ion with Respect to Citation of 

m (EPA Form 8570-34) - if 

Certificat 

Data For 

,re.9u.i~e9, __ N ___ ~_~_ 

Minutes on data requirements (pre-

,J_~_gj§!!at~ or)}!l~~ti~gL 

Active in 

code) 

gredient # (i.e. Chemical PC 

• 

• 

m ore than one active? 

a re __ all N ____ actives housed in BPPD? 

---------- , Signed I Dale Abs 

I nl 

e 

, 

X 

1 1/30/0 

X 5 

1 -

----- -- I 

i 

, 

i I 

1 

I 

I 

1 

~---~ 

X I 11130105 

--~~ -'''- I· 

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

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

Comments 

Registered product is 

is a me*too product of 

of which formulator's 

exemption was requested for 

me*too registration application. 

""No formulator'S exemption is 

requested for this application. 

Because they used cite*all 

method (& willing to pay) 

cite all method 

NA 

pee: 46701; housed in BPPD 

149 *Product ingredient source information may be entitled to confidential treatment*
Admin Malerials Signed Dale 

.................... ~~~. ~ .......... 

m~~~~~ _ 

Jacket from EPA Ide ntifyingSymbol .. 

Are MRIDS assigned 

comments) 

? (State Yes/No in 

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

Background Experim ental Use Permit 

information, if applic able 

• request for te mporary tol. 

exempt, toL e 

numeric toler 

xempllon or 

ance? 

.. note af! com 

petition and 

critera. 

ments - refer to 

fr section for 

_ditional Comments: The 

~pljcation (me~too) is for registration 

for a new source of AI. 

• 

, 

... 

-------

, 

-----

Abse 

n I 

.. 57538·ET 

Y 

Comments 

150 
CHECKLIST FOR DATA PACKAGE SCmNCE SCIlliEN 

Active Ingn..>dients: Indole M3Mbutyric acid 

PC codo: 46701 

Product Nome: IBAMTech 

EPA Reg. No/File Symbol: 57538-KT 

Petition 1/ (if applicable): 

,Cird, or Check 

Uiochemiclll, Microbial. or PIP 

rood Use 

i I I'lleromJlnc 

~'\"i,c':n:::::"" Sec. 3 Registration 

Expcrimenlai Usc Pennit 

m.-4 SlIbmission 

Melhyl Bromide Alternative 

Reduced Risk Product 

e Bm,,' 

Product Type 

B M p 

y N 

Y N 

Y " 

Y 

y N 

y N 

Y N 

Y N 

l'ro<!m.:t Specific Information 

Dl1la Requirement TGAI MP EP 

!IAbel Iy 

Produl't (' , 

csr y :\ mlidificd csr.- (he {lew 1>uurcc is subllJiucd 

PrOduclldcmilY & Composition Y SltIdy subllliucd in MRID#4670S3·03 

, i Process Y SlIld), sllhmincd in MRID#.t670SJ-O, 

Description oflhe Fnrmalinn of Y Stndy :-.uhmincd In MRI1J~4670S3·02 

Preliminary Analysis N SlUdy sllbmilled 'm MRJD#4671183-OJ 

Cr:rtifiecl Limits Y I Study submitted in MRID#4670R3-f!3 

Analytical Mcthnm \' Study submitled in MRID#4670lB-03 

1'II\,sk;\ltChentlcal I (a~ sh())\'n Y . orphyskhcm ~ubmittcd i1ccoTiling 11) PR 

'" 40 CFR 15S< 190 T,blt) I NOI",9S-1 -

Tier I ilJ{)katc in Comments irwaivcr.- , 

151 
AcuteOrnl There should be a modified data matri).: reilceting, 

~tudy guideline reference number indicating which one 

i<; which in order to ]lny comflCn~ationlfj)munting is. not 

properly dnnc in data matrix 

Aeqte Dermal " 

Acuh: lJ)hnlation " 

I.e, 1.1'., I.V. Injectiol! (Micnlhi:ll " 

only) 

Dermal Irritation " 

Prim;)fY Eye Irritillion " 

, ; , '" " 

• ; , Incidents " 

, required) 

Genot(lxocity Studies (lhdu:miclll " I ol\ly) 

Imnwllc R~"pimsc " 

Tissue Culture 

<)()..uay Fceding 

(Binehcmical~~~ly) . 

91J·day Dermal 

(Biochemical only) 

I ~2~d~: hlh'llation , I oolv) 

~ ,fOil"') 

loxicity 

Tier I Non-Target Orgamsn)\ (Irnn ~tuuy, inuil.";'lte in Comments if waiver s.ubmhted) 

A~'i;m Aente Oral 

A villn Acute Dietar:.' 

frcslt\vater Fish LC50 

Frcshwntcr ln~'crtchratc I.C50 

Non-larget Plllnts 

'.J'" ""1;'" Ins.ws 

}Ioneybce Testing 

I,," voo1v) 

152 
Other Studies {As required by pr(IUuct s!X~it1c datil requiremenL<;.(e.g. eflic<lc),. rcs.idues) 

• 

• 

153 
Science Screen Comment Form 

Active Ingredients: Indolc-3·butyric acid 

PC codes:46701 

Product Name: InA·Tech 

EPA Reg. NolFilc Symhol: 57538·ET 

RAI.: And)' BryceJand 

Status: f' /1 S 5 

THIS FORM CONTAINS CONFIDENTIAL BUSINESS INFORMATION 

Product Chemistry: el requirement is addressed by submitted studies uppear:, to be adequate. 

Toxicit)·; 

Data requirement is addressed by cite all method. difficult to understand. For details please sec above foon. 

Non~targct Organisms! Environmental Fate: 

Om:! requirements addressed by dte all method. Willing to pay if required to TechniOora Plant Products 

(tnd Miller Chemical and i'cnilizcr company, C& R Products. Agricarc comp<my, Syntex S.A, de C. V. 

comp,my. 

Product Performance (Efficacy): 

not required 

eldue: 

i[ was exempted per 40 CFR 180.1073 for :.1gricllltmal commodity such Wi Maccdcmia nut, apple), for the 

usc inIon Quince exemption petition it is 98717. 

Other non guideline or supplemenfallnforntation: 

CommentsIRecommentlatiolls: 

154 
• 

• 

, 

BPPD Screen Package 

Front Elld (Team Leader fbi It's . __ l 

Produ(;t Name: IPoA 75AI 

File Symbol No. 

Active Ingredient: 

Date In IlPPI): _u~~l i~l)f) 

Date To Screen Team: __ LI1-'=-j/.L~':"'41· ~:.-,SL' _ 

Package (RAL....1k~rn------) 

Pre-Registration Meeting l\lhtutes:'-D Yes 0 ?'Jonc 

PAl! ~ 4ft J;y 

fJ-FtYOD 

•• '>./1 

o Non·FOOD 

~lIbrnis$ion 

o Rcsubmission 

See Administrative Material Checklist for information .lOd comments on label, CSF, forms. etc. 

Comment: 

Jacket: 0 Attached 0 NOl Present for Science Screen 

Science Screen 

Scientist: 

Administrative Screen: o Pass 0 Eli I 

Science Screen: o Pass 0 Fil.i I 

lik Scrn!'.lC1: ,-lIkSlir.wpd 

155 

-_ ...................... -. 
Date Expected From Screen: (10 days from date in): J - 3 -c2 (p~~_ IV A# tJS-- 37_ 

Nasrin BegUm&~ Q,Q(l:~AC~ HOurs~ ~ ~ Return~PPD 16/00 

Received Date from Contac<or: J L§j[~~~~y------ SCREEN PACKAGE NOTES: 

Pre- Reg, Meetings attached: Yes No 

Submission complies with aU applicable areas of checklists? Indicate in detail on checklists 

forms when returned. 

Additional Comments per Team Leader or Screener: 

SCREEN STATUS 

Administrative: -8 Fair 

Scicnti fie: -~ Fad 

~ /U'UU 

• • 

(CJ 

I.(') 

..-
• 

• 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

Dccenrbcl" 13.2005 

STOLLER ENTERPRISES, I~C 

"001 IV SAM HOUSTON PKWY 'I, SUITE lOll 

HOliSTON, TX 770-11 

Report of Analysis fur Compliance with PR Notice :-;(\-) 

,-WI'ICLOj· 

1'!1J'\'I-~'ll0"'. I'ISTKIDES ,\Nn 

il 1"le Sl1JST,\NCI-.S 

Thank you tor your srrhrlliual ofU7-DEC-05 Our slafflras col11pleted a prelirninal), 

ana!y~is orthc l1luterin! The resl1l1s i1r(~ provided liS f()lIow$ 

Your submittal \vas tound tn be in fi.11I compliance with the standards fi)r $uhmission of 

datil colllained iu PI{ l\u!ll'e 86-5 A copy OfY(lOf bihliography is ~ndosed, onnotatcd with 

\1aster Record ID':=; (MRIDs) ;rssigned to each docllment sllbmiltcd Please 11~C these number5 in 

all filture reierenccs 10 t1rcse dOCllln(,l1ts Thl1nk you I;x your cooper,ninn IfYOll have «ny 

questiorr!'> concerning tltis dala submission, p]Cil:;L' rai,,\? ri1em with lire (;ogni.ulllt PrOdlrcllVlannger, 

In whollllltC dMa h\1ve lreerr released 

157 
• 

• 

IFee for Servicel l II~JJ,~III!llllllll 

This package includes the following 

". New Registration 

:) Amendment / 

i<! Studies? 4ee Waiver? 

n volpay % Reduction: _ 

for Division 

')AD 

(.) BPPD 

cRD 

Risk Mgr. lliJ 

Receipt No. 8-1 787686 ;::::==:::::~~=~ 

EPA File Symbol/Reg. No. :::::1 ==57=5=3=8=-E=T===: 

Pin-Punch Date: LI __ 12_/_7_/0_5_---' 

This item is NOT subject to FFS action . 

Action Code: 

Requested: I 

Granted: I ~== [) c:"l 

Amount Due: $ if LUi) 

..... {:. .. !i • /--- I If \ II / ReViewer: .;( •. L·r ~ .' , • 

Parent/Child Decisions: 

Date: (z..0z!) i-- , 
• 

• 

DATE: I,p./"/D~ , -'-"---------

FEP (OPPIN ENTRY): 18-/" /6rfaw7 - i-I 

(Initial & date) 

FILE ROOM: Q ut\ \ J. \)0\ c'S, 

(1nitial & date) 

SJG: 

(Initial & date 

FILE HOOM: 

. (Initial & date) 

x SS G q / ;1 A<.'..'I 'N TO PM ,! 

. 

159 
• 

FEE FOR SERVICE 

• 

160 
, 

• 

• 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

December 20, 2005 

OHICEOf 

I'REVEN1'()~'. pr~'inClI)E~ ANO 

TOXIC ~1 mSTA:-;CEi; 

PLEASE RETURN A COPY OF TllIS LETTER WlTH PA YMENT 

orr Decision ~Ilmbcr: D-363126 

EPA File Symhol or Registration Number: 57538~ET 

Prodlle' Name: STOLLER TECIll'ICAL INDOLE-3-BUTYRIC ACfD 

EPA Receip( Dale: 07-Det>2005 

EPA Company Number: 57538 

Complluy Kame: STOLLER ENTERPR1SES. r~K' 

LEANNA S?-l1TfI 

STOLLER ENTERPRISES, INC' 

4001 IV, SA:'1 HOUSTON PKWY t-:, SUITE 100 

IIOIISTON, TX 77()43 

SUBJECT: Receipt ofRcgistralion Applicalion rind 50n,{, Small Rnsiness \\/aiver Request 

Dear Registrant: 

The OlTicc of Pesticide Progl'ums has recc1VCU your application for registration and 50% 

5111all business wain~r reqllest. If you submitted data \\<lIh this application, the results of the 

PRN~86-5 screen will be cOillmlluicatcd separately, During the ndlllinis(rative Screen. the Office 

of PesticiJe Programs has detennincd that Ihis Action is subject to a Pesticide Regislration 

Seniee Fcc as defined in tlte Pesticide Registration Improvement Act. 

The Action has been idcnti tied as Action Code: 867 

"ElY pRODUCT,,,Ot-:-F AS'!' lRACK;MICROBIAI/BIOCHEMIC\L; 

Your request f()r waiver h,\s been forwnrdcd for review. You \ViII bc 1I0titled in \"Titing when a 

detenl1ination is made regarding J'otlr request. If your waiver request is approved, Ihe decision 

review time' period will start 011 either the date of approval or the receipt or payment, whichever 

is la!i!c If you wOllld likl.! (0 avoid delaying Ihe start date. YOII may pay the amount listed below 

at this lime. If yom waiver request is denied. yon will receive an invoice for the outstanding 

hal<mce. 

Please remit payment 111 tlle amount or: S 2, IOU to. 

161 
ByUSPS: 

US EPA Washington Finance Center 

Pesticide Registration Service Fcc 

PO Box 360277 

Pittsburgh, PA 1525 t 

By Courier: 

UX EPA \Vashington Finance Center 

Pesticide Registration Service Fcc 

C/O Mellon Client Service Cellter 

500 Ross Strect. Room Ci]U 

Box 360277 

Pitt.sburgh, PA 1525 t -6277 

Allo: EPA Module Supervisor 

Telephone: (412) 236-2294 

e All pa)-1nents mllst he in Unitcd States currency by check, bank draft, or money order 

drawJl to the order of the Environmental Protection Agency. Tn ellsme proper credit, please 

write the OPP DECISIO;-"; NtJ\fBER on your check. and enclose a copy of this letter with your 

paY111l'I)t. 

• 

A PRlA deciSIOn timc review pcriod will not start until a fee waiver is granted andlor the 

Agency r!."ceives t:ertification that the outstanding fcc has heen paid. lfthe Agency does not 

receive certinnltion ofpaynwilt for this. action or a fcc wili\·er request within the next 45 days, 

the Agency \vill prCSIlillC that you no longer want to purslle this actioll. The Agency \\'dl then 

initiate it process that may result 111 administrative Withdrawal of this action. 

1 f yon have <lny qllc!';tions. picas\." contnet the Pesticide Registration Service Fee 

Ombudslnao at (703) 308·8260 . 

Sincerer //..-"') /.~r1 

7i2- /. J'// C7 '/. / 

<-.... +ront End ftfoccssins. taff / 

Inform::tll'on Tecllltology & Resources YlanagCOlcnt Division 

162 ... _------------------
""I'm. AW"w.,.,! OUB N". 101t).00(,() 

~ .... UNITED STATES ENVIRONMENTAL PROTECTION AGENCY (:t 

~ \ 401 M Sf,..t, S,W. 

WASHtNGTON, D,C. 2046{) 

d I """ "" "'~""- .' 

I ~p~~ "'- I 

I i:'u-; ProIox;bon A~, 401 M SlrDet~ S oj';, washlngtoo. f}() not 000d II-.. 

SfPR 

I. PRODUt-"T NAME: T e<:hl1ic.1! !ndolf.;.:Hlut~ h;1d ! lOA) 1. ft". So. 57S38 .. XX 

3. COMPANY NAME: Slo!i.l< 1-"IH'l."i~"~ 4. SUBMISSION nAl'E~ 

11!30106 

• I :: FUll" 1. rE.'mCl()1t TVP£: PGR to. REGISTRATION Ql 

I ,_ .. - ~ " .. lID I II. 

13. PRODUCT MAN"-GER OR CHEMICAL REVIEW MANAGER '/NAME flY KNOWN): Sh<)ryl ROIifyl91 11. IlEREG CAS!.: , 

14. (;lJJD£UNE RKFJ:RKNCfo: 16. MIUD .... R.I!.PORT NO. 

G~ B.Series (<to CFR. l58.,l90) 

,~,., C.I., whk1) powder tillJ all 

""" • sO!~1 

"'" 000, IlCfll'!JtbkJ · 

(I'K-'O(npalilihl wdh (;lfOOlI ')~I'h/!'r.:; ·6314 Oli4lllim"'Rtdu~tif)n' · 

• '" ,ui 

IN" • • .ti315 I •••••• • 

"" ~kol*",liry NtA :-.. • 

••••• 

-6311 SIn,..,,, Stability I, I arnolt)fll Icmpfmdum · . • • ••• 

• • •••••• • ••• • • •• ••• ! 

6319 MiKibility , wlubklm alcohol. ;)C\!l()()f> · • • ••••• • 

~"o eorro:»lOtl Cbar.w,riotio N" •••• 

• • •• • · • •• • 

-6321 Dideottie lk ... k<:l"",ll. 111011°' 11Wlll1 or i'lrourxl electncaJ CQUIPOl:)U! 

.""" ,II nu! wklllW., water · 

-7!00 V~,'" N'A 

om<> 658!bIOlU 

,,~ 

163 
->. 

(J) 

./:>. 

n 

\.::m) 

• • 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M &reet, S.W. 

WASHINGTON, D.C. 20460 

F0f1P !INlfOV(';l OMR N" 2!J1!HX)i)(! 

P"pe-!work Roou<;Uon Act Nollce. Tl\\" pflDlI<: f<;P0tlflg b,",;>~nl(r tll(~ ;;~'~":I'f,1f "I ,"h~,n;f!~_'"I~ "hl~"~!"'! h)il1fflr<l!I" O?h n'''f~; I"'" f,""I"_~_ hv !"'i\,hlfillbn ,}('\oV.I>~'S ,m.;! 0 25 110W" pGl fC$;i(TC(' fe( 

f~etl,,;i!il.I~:" ,m,l ~I'''':;I~I ,..,."".~ ;gi'lf'ti(l" :nd!J!h-'li;l tJrn(, t-;l! fo-l(H~; !rc 1I"'!IfMi~!f~, <11"1 o;~flp1"111~11(,,, m.,""',.,~~tV I"""" S"""I ,xIII"n .. "I,. 'B;I<l'fk"IIi''I !~"d,~) r;hl¥""j,) U "ny {AlfCf ,:>-IKd OJ! I!~S""I.'M<::I() W 

'!~':<OfH',I"}If_ ,'dfl:hlP ~'\fI'f'""'>\«"h [;;( P(lIICU!if Wh buf(i0f1iQ D:f'~'<1,01 UPPL 1"~NIff.ll;:·n "'1~Hifqd"f\\l~ Du";,,,,, {;:>!~i'! \ I S F, ,wl",",,'nj<ll Pml ... :I",,, N!"W;\', .11)) M ~'I!.)<:I, :;, W W~;',II'!~ll01l, OC 20~0{) I)e. w. ~Clii! lh'J !wn 1'3 :t~3 ;Y1(lr,~SS 

DATA. MATRIX 

Onh! NO\! 30 200" F?I>. R'~I N" '''''l $V11\ld 57:\:-18· xxx Tl'a(,",' 0' I 

l'Plilcil.n!'$/1 KXlI$!r&I-~ 1,1,11)10 & AdJfc'~b IJ'0.i'JCI 

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'lfg~;(IIl'ff( \1tM.~l""f' ,d"I">r"I" !"lHh\~lfI)l~ 

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cnF-Ali 0!0'N ~"('I') <r;c ,.nYJ()O) PAY 

OTE_IiI! 110."","" i:1",,'W;al Cp ;~'hl(6) I'A.Y 

(;Irr·AcL (;VlfJlf>Cll fnINII(;~,,~, !IJfl;>!111 PAV 

• • • • ••• •• • CI f[·I\[! GMWU, I ,'<,hf"'li11¥ ! 1<1, i7",~",-1 I PI'''' 

• • • • 

• • • • • 

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orF·/k Ag~I,.:.mJ ~,{; (7:':.,";,17! rcr.y 

• • • • • •• •• • 

• • • • • • • • • CP L • .lI~1 syr'l<1x (3{!O7?) PAY 

• • . • • • • • 

•• • • • • • • • • • • • • • • • • • •• 

••• • ••• • • • ;QQ.1k- ":;"1""1,,,,, N;)!!W affl1 I Ale 

ONl O'tllf~lIgl'n,,:sw. Ph 0 OABT. Jlnen! [.y $Inthn 

U;)!0 

Nov ::I<!, (';JO:> 

fT'r, r.;nH f\',lfj;I,;i;j;iiiii'itX,lfi;<W' flflll Mq";f V(:fSIOIY.. aV::IIl(lG.:"'---:WJnI:l o,lIy I'ap·~! Vr:1S,:;''' AgDney Illterrnll Uso Copy 
• 

• 

Footnotes 10 Data Matrix dated Nov. 30, 2005 

Technical Indole-3-butyric Acid 

Stoller Enterprises, Inc 

Footnote 1: See CSF. Certijied limits as per 40 CFA defaults, and supported by 

single report for 830-1700,830-1750,830-1800 (Wright, M., McKenzielWright 

laboratories Study No. MKl04 - 0124, submitted in this transmittal) 

Footnote 2: Guidelines 830-1700,830-175,830-1800 are satisfied by a single 

study (Wrigh~ M., McKenzielWright laboratories Study No. MKl04 - 0124) 

Footnote 3: Per FIFAA 3(c)(1 )(F) requirements, Stoller has made an offer to pay 

for all valid studies supporting technical kinetin, including physical chemical 

properties, to all those on the most current Data Submitters Ust listed as having 

submitted data supporting a technical or manufacturing use product and whose 

data would be required to support the subject application at the time of its 

approval. We further note that no offer to pay is required for those submitters who 

are listed as having submitted data relating only to end-use and not 

manufacturing use products. Further, we note that the SDTF, OAETF, and AATF 

are noted as data submitters. However, their data are not required for this : ••• :. 

application at this time since EPA waived requirements for worker exposure olwe. 

to the low toxicity of the product. : •••• 

•••••• • 

• •• • • 

• ••••• • • •• 

••••• 

.. • • ~ .. 

• ••• 

• • •••• 

••• • • • •• 

• ••• o • 

•••• 

• ••• 

• • •• • 

165 
• 

• 

November 28. 2005 

Syntex S.A. de C.V. 

DiviSion Qulmica 

3808 Luneta Lane 

Fallbrook, CA 920;28 

RE: Ol'fer~ To-Pay compensation for citation of data, Indole~g..butyric acid 

Siolier Enterprises, Inc. Intends to apply to US EPA for regisltatioo of a technical indole.3-

bulyric acid product using the 'clte-alr method of data compensetion. The name of your 

company was listed In the US EPA Data Submitters Ust as having suppUed relevant data to US 

EPA to eupport at I ••• t on. rvgistmtion of a manufacturing-use indole-3-llulyric acid producL 

Aoconflngly, Stoller Enterprise. hereby offe", to pay ccmpensation to Syntex SA de C. V., to 

the extent "'qulrod under FIFRA § 3(c){1)(O), for citation of all da .. in the Agency'. Bleathst (1) 

concern the properties or effects of this product or an identical or .sub$lantially sfmllar product; 

and (2) are a type of dats that wouJd be required to be submiHed under the data requirements In 

effect on the date of approval of Ulis application If the appUeation sought the initial regisbatioo of 

a product of identical or similar romposition and uses. Stollet Enterprises offers to commence 

negotiation to detennine the amount and terms of compensaHon due. if any. for the subjact 

studies . 

Pl .... note the~ .s required by FIFRA 3{c){1){O), the present offer i. limlted 10 geMric data 

supporting technlcoJ or manufacturinfl"US$ indole--3-butyric acid, and not related to any product~ 

specifiC data whlCb may have been provided 10 US EPA by Syntex S.A. de C.V. to 8UPpcll only 

end~use products. 

n Syntax SA de C. V. determines that compensation Is due, please .... pond to the undersigned 

wnhin 60 days of receipt of this letter. In this event, in order to facilitate discussiOOS, pte .... aloo 

list the specific d8ta that you be1ieve are compensable, inQuding study title, date of submission 

to US EPA, and US EPA MRID number. 

If no response is received within 60 days. Stoller Entefprises. Inc. will understand that no 

compensetion Is requested by Syntex SA de c.v. 

Sin<:erely, 

~~ Regulatory Manager 

166 -------------~-----.----------- ... 
November 28, 2005 

Agrlcare Inc. 

PO Box 399 

Amily, OR 97101 

c$) 

Stoller Enterprises, Inc. 

"......,111.". ...... 

4001 W. s.m _ f'IIwy, N .. Suite tOO I """"" lX 77043 

Pha!t: 713-461-1493 I FAX: 713-481-4461 I WW\I¥.SloIlerUSA.oom 

• RE: Offor-To-Pay compensation for citation of data, indole-3-butyric acid 

• 

Sioller Enlerprises, Inc. intends to apply to US EPA klr registration of a technk;al incfoIe-3-

butyric acid product using tho ·cite-alI" method of dala compensaUon. The name of your 

company was: listed In lhe US EPA Data Submitters list a6 hilving supplied reJeV'ant data to US 

EPA to support alleast ooe registration of a manufacturing-use indole-3-butyric acid product 

Accordingly, Stoller EnterprlGeS hereby offers to pay compensation to AgricerG Inc.. to the 

extent ,,",uired under FIFRA § 3{c)(1)(O), for citation of all data in the Agency's fiies that (1) 

concern the properties or effects of this product or an identical or substantiaHv similar product; 

and (2) are a type of data that would be required to be submitted under 1M data requirements In 

effect on the date of approval of this appUcation if the eppllcaHon sought the initial registration of 

a product of kfentical or similar composition and uses. Stoller Enterprises offers to commence 

negotiation to delermine the amount and terms of compensation due, if any, for the subject 

studies. 

Please note that. as required by FIFRA 3(cX t }(D). the prtl$OOt offer is limited to gtlllfIric data 

supporting t9Chnlca/ or manufBC'Itlrin!ruse IndoJe-3-butyric acid, and not refated to any productspecific data which may have bean provided to US EPA by AgrIcaI'9 Inc. to support only enduse products. 

If Agricare Inc. determines that compensation is due, p'0ase respond to the underslgned within 

60 days ot receipt of this letter. In this event. in order to facilitate discussions. please also list 

the: specific data Ihat you beflsve am compensable, Including study IiUe, date of submission to 

US EPA. and US EPA MRIO number. 

If no response is received within 60 days, Stoller Enterprises. Inc. will understand thai no 

compensation is requested by Agricaf$ Inc. 

~~ leanna Smith 

Regulatory Manager 

167 
Stoller ~ Enterprises, Inc. 

Ji.......,dlllt_ ... 

4001 W. Sam _ Pkwy. N .• _,Oll I _.1)( 77043 

PI>ono: 71).<'!f.1493 I FAX: 71).«114467 I www.StoIIerlJSA.COO1 

November 28, 2005 

C & R Products 

18210 NE San Raphael 

Portland. OR 97230 

• RE: Offer-TcrPay compensation for dtalion 01 data,lndole-3..tlutyric add 

• 

Stoller Enterprises, Inc. intends to apply to US EPA for registration of a technical indole-3. 

butyric acid pnxlucl using the ~cite-alr method of data compensation. The name of your 

company was listed In the US EPA Data Submittern Usl 8S having supplied relevant dafa to US 

EPA to support at least one registration of a manufacturing-use indole-3-butyrlc acid product. 

Accordingly, Stoller Enterprises hereby otfer& to pay compensation to C & R Products, to the 

exlenl requlned und.r FIFRA § 3{cXl){D). for citation of all data in Ihe Agency's files that (1) 

concern the properties or effecta: of this product or an tdenUcaI or substantially similar product; 

and (2) are a type of data thai would bo required to be submitted under the data requirements in 

effeet on the <:tate of approval of this application If the application &Ought the fnftJal registration of 

a product of identkal or similar composition and uses. Stoller Enterprises offers to commence 

negotiation to detennine the amount and tenos of compensation due. if any, (or the subject 

sludies. 

Please note tnal. as required by FIFRA 3(cX1XO}, the present offer is fimHed to generic data 

supporting technical or manufacturing-use Indofe--J..butyric acid, and not related to any product~ 

specffic data which mey have been provided to US EPA by C '" R Products to support on1y enduse products, 

If C & R Products determines thot compensation is due, please respond to the urlder5fgned 

within 60 days of receipt of this letler. In this event. in order to factllta1e diSCUssions. please also 

list the specific data thai you believe are compensable. including study title. dale of submission 

to US EPA, and US EPA MRIO number. 

If no response is recetved within 60 days, Stoller Enterprises, Inc. will understand that no 

compensation is requested by C & R Products, 

~~ Leanne Smith 

RogUlatory Manager 

168 
• 

• 

November 28. 2005 

--~ ... - .... --.-

cSS 

Stoller Enterprises, Inc. 

".-y .. I\ot!loollor~ 

<001 W. s.m _ PI<wy, N .• _ 100 I _. lJ( n043 

PMoo: 713-461·1493 I FAX: 713-461-4461 I WIVI¥.$toIerUSA.com 

Miller Chemical and Fertilizer Corp. 

PO Box 333 

Hanover, PA 17331 

RE: Offer·To~Pay compensation for citation of data, indofe~3..butyric acid 

SImler Enterprises, Inc, intends to apply to US EPA for reglslrallon of a technical indole-3-

butyric acid product using the ·cite..alt method of data compensation. The name of your 

company w8slisted in the US EPA Data Submitters list as having supplied relevant data to US 

EPA to support alleasl one registration of a manufacturlng~use j~e--3-butyric acid product 

Accordingly, Stoller Enterprises hemby offers to pay compensation to MIller Chemical and 

Fertilizer COIp., to the extent required under FIFRA § 3(c)(1)(O), tor citation or all data in the 

Agency's flies that (1) concern the properties or effects of thts produet or an Identical or 

substantially similar product; and (2) are 0 type of data that woukf be required to be submitted 

under the data requirements in otf&ct on the date of approval of this appHcation If tho application 

soughl the initial registration of a product of identical or similar composition and uses. Stoner 

Enterprises offers to commence negotiation to detennine the amount and terms or 

compensation due, If any. for the subject sludles . 

Please note that. as required by FIFRA 3(c)(1)(D). the present offer ISl:imited to generic data 

supporting t&ehnlcal or msnufacturlng--uN 1nd01e~3-butyric acid, and not related to any product~ 

speciflc data 'IIflich may have been pro¥lded to US EPA by Miller Chemical.md Fertllizer Corp. 

10 support only end-use products. 

If Miller Chemical and Fertilizer Corp. delermines thai compensation Is due. please re5pOl1(f to 

Ihe undersigned within 60 days of receipt of this: letter. In this event, in order to facilitate 

discussions, please also list the specific data that you betleve are compensable, including study 

title. date of submission to US EPA. and US EPA MRID number. 

If no response is received within 60 days, Stoller Enterprises, Inc. will understand that no 

rompensation Is requested by Miller Chemical and Fertiliz&f Corp. 

Sincerely, 

~~ leanna Smith 

Regulalory Manager 

169 
• 

• 

cSS 

Stoller Enterprises, Inc. 

"....-,. ............ <00, W. Sam _ Pkwy. N .. _'00 I _. TX n043 

_: 713-46HIi3 I FAX: 713-46'_ I ""'.StOilerliSA.OlI1l 

November 28, 2005 

Techniflora Plant Products Ltd. 

c/o ChemRog International 

'990 Old Bridge Rd . 

Suite 201 

Lake Ridge. VA 22192 

RE: Offer-To-Pay comp9nsstion for cltation of data, indoJe..3-butyrlc add 

Stoller Enterprises, Inc. intends to apply to US EPA for mgistrnUon of a technical ind0Je..3.. 

butyric acid product using the ~cite-an· method of data compensation. The name of your 

company was listed in the US EPA Dala Submitters Ust as having supplied l19levant data to US 

EPA 10 support at least one registration of a manufacturing-use indokJ...3-butyric acid product. 

Acco«.Iingly. S10ller Enterprises hereby offers to pay compensation to Techniflora Plant 

Product. ltd .. to the extont required under FIFRA § 3(c)(1)(0). for cita~on of aN data In the 

Agencys lIlesthat (1) concern the properties or effects of this product or an i<IonHcaI or 

substantially similar product; and {2) are a type of data that would be required to be submiHed 

under the data requirements in effect on the date of approvaJ of this application If the application 

sought the initlat reglstrntlon of 8 product of ldentical or stmllaf composition and uses. Ston.r 

Enlerprises offers to commence negotiation to detennlne the amount and terms of 

compensa1ion due. if any. for the subj&ct studies. 

?tea.e note that. as required by FIFRA 3{c){1 )(D), the present offer is limited to genedc data 

suppor1lng technical or manuf&cturing-uSfl indole-3-butyrlc add. and no1 ra/ale<! to any productspecific CUlts which may have been provided to US EPA by Techniflora Plant Products Ltd. to 

support onty end·use products. 

If Techniftora Plant Products ltd. determines that compensation is due. please respond to the 

undersigned within 60 days of receipt of this letter. In thit event. in order to fadlttate 

discussions. please also list the specific data that you beHeve are compensable, including study 

title, date of submission to US EPA. and US EPA MRID number, 

If no response is received within 60 days. Stoller Enterprises, Inc. will understand that no 

compensation is requested by Techniflora Plant Products Ltd. 

~IUW~ L nna Smith 

Regulatory Manager 

170 
• 

cSS 

Stoller Enterprises, Inc . .1.....,.'''Il0l ........ <001 W. s.m _ PI<wy, N .• Stile 100 I _, TX 77043 

Phone: 713461~1493 ! FAX: 713-4614467 ! WiM'.stolerUSAc:om 

November 28, 2005 

Growth Technology ltd. 

C;/O ChvmReg International 

1990 Old Bridge Rd. 

sun. 201 

lake Ridge, VA 22192 

RE: Offer-To-Pay compensation tor citation of data, indoJe-3~bulyric acid 

steUer Enterprises. Inc. Inlends to apply 10 US EPA for registration of a technical indoJe-3-

bulyric add product using lhe acite-alla method of data compensation. The name of your 

company was listed in the US EPA Data Submitters list as having supplied relevant data to US 

EPA to support alleasl one registration of a manufacturing-use indola-3-butyrie acid product 

Accordingly. StoUer Enterprises hereby offers 10 pay compensation 10 Growth Technology ltd .• 

10 the exlenl required under FIFRA § 3(0)(1)(0). for ci1aIlon of _II delaln the Agency's files lhot 

(1) concem the properties or effects of Ihis product or an identical or substantially simUar 

product; and {2) are a Iype of data lhat would be requfred to be submitted under the data 

requirements in effect on the date of approval of this application if the application sought the 

initial registration Qr a product of identical or similar composition and uses" Slolier Enterprises 

offers to commence negotiation to determine the amount and larms of compensation due, if e any. for the subject studies. 

Please oole that, as required by FIFRA 3(c}{1)(O), the present offer is t/mited to generic data 

supporting technlcsl or msnufacturing..use indoJe-3..butyrlc acid, and not related to any productspecffic data which may have been provided to US EPA by Growth Technology Ltd. 10 support 

only end-use products. 

It Growth lechnology ltd, delermines that compensation is due, pfease respond 10 the 

undersigned wilhin 60 days of receipt of this letter, In this evenl, in order to facirrtate 

discussions, please also Ust the specific data that you befteve are compensable, Including study 

litle. dale of submission to US EPA, and US EPA MRIO number, 

If no rosponse is received wilhin 60 days, Stoller Enterprises, Inc. will understand that no 

compensation is requesled by Grow1.h Technology ltd. 

Sincere{y, 

~&fJ-- Leanna Smilh 

Regulalory Manager 

171 
• 

• 

c$) 

StoDer Enterprises, Inc. 

A.....,OIIIIIo __ ,.. 

400t W s.m_ Pkwy. N, $Ute 100 I Houmn, TX 17n43 

F'Ilone, 11~1-1~93 I FAX: 11~1-«67 I _.SloltorUSA.'" 

November 26.2005 

Cytotech Enterprises. Inc. 

c/o Pyxis Regulatory Co. 

4110 136th SI. NW 

Gig Harbor. WA 98332 

RE: Offer .. TtrPay compensation (or citation of data, indof&-3-butyric acid 

SteUer Enterprises, Ino. Intends to apply to US EPA for registration of a technical indola-3-

butyric acid product using the ·~ito--all· method of data compensation. The name of your 

company was listed in the US EPA Data Submitters Ust as having suppJied relevant data to US 

EPA to support at least one registration of a manufacturing-use indole-3-butyrtc acid product 

Accordingly. Stoller Enterprises hereby offers to pay compensation to Cytotech Enterprises, 

Inc .• to the e><tont requilVd under FIFRA § 3(c)(1 XD). for citation of all data in the Agency's fiI .. 

that (1) COflcsm tho properfl.s or eft'e<:ts of thl. produ'" or an MonGcal or substantially similar 

product; and (2) are a type of data that would bs required to be submitted under the <lata 

requirements In effect on the date of approval of this application if th. application sought tho 

initial registration of a product of identicaJ or similar composition and uses. Stollar Enterprises 

offers to commence negotiation to determine the amount and terms of oompensation due, if 

any, for the subject studies . 

Pleas. not.the~ as requ_ by FIFRA 3(c)(1)(D). the present offer i,limlted to generic data 

supporting technical Of manufacturing-use indohJ..3..butyric;;; acid, and not related to any productspecific data which may have been provided to US EPA by Cytotech EnIOlpri ... , Inc. to support 

only end-use products. 

If Cytotech Enterprlses, Jne. detennfne$ that compensation is due, please respond to the 

undersigned within 60 days of receipt of this letter. In this event, in order to facHitate 

diSCUSSions, please also list the specfflc do:ta that you believe are compensable. including $tudy 

title. dato of submission to US EPA. and US EPA MRIO number. 

If no response fS received within sa days, Stoller Enterprises, Inc. will understand 1hat no 

compensation is reqUBsted by·Cytotech Enterprises. Inc. 

~~ Leanna SmIth 

ReguJatory Manager 

172 

I 

, 

, 
• 

• 

c$S 

Stoller Enterprises, Inc. 

A...-rctn. .... c.... 

4001 W. Sam _ PIoNy, N., _ 100 I _, TX 77043 

_______ -''''''''"'==7,,' .... c:::',,-'c.:493c:..cI..:.FAJO=-.:· 1" .... '~ I _:Slol"'-'rU..:.SA"."""= ______ _ 

November 28, 2005 

Helena Chemical Co. 

225 Schilfing Blvd. 

Suile 300 

CollierAUe, TN 38071 

RE: Offer-To-Pay compensation (or citation of data. indole-3..butyric acid 

Stoller Enterprises, Inc. Intends to apply to US EPA for registration of a technical indole-3-

butyric acid product usJng the "cite--all" method of dats compensation, The name of your 

company was listed In the US EPA Data Submitters list as having supplied relevant date to US 

EPA to support at least one registration of a manufacturing-use IndoIe·3-butyric acid product. 

Accordingly, StoUer E:nterprises hereby offere to pay compensaUon to Helena Chemical Co., to 

lhe extenl requlned under FIFRA § 3(cX1XD), for citation of ali data in the Agency's files that (1) 

concern the properties or effects of this produd or an identical or substanllaUy similar product: 

and (2) are a type of data that woukJ be required to be submitted under the data requirements in 

effect on lhe date or approval of this application if the application sought the initial registration of 

a product of idenlicaf Dr similar composition and uses. Stoller Enlerprises offers to commence 

negotialion 10 delermine the amounl and lerms of compensatlon due, if any, for the subject 

studies . 

Please nol. Iha~ as required by FIFRA 3(c)(1 XD), the pre...rn offer is limiled 10 generic data 

supporting tf1chnic81 or manuf8Clurlng..uselndoJe..3-butyric acid, and not related to any productspecific data which may have been provided to US EPA by Hefena Chemical Co. 10 support 

only end.uge products. 

If Helena Chemical Co. delermines that compensalion is due, please respond 10 lhe 

undersigned within 60 days of reooipt of this krifer. In this evanl, In order to fadlttate 

discussions, please also list the specific data that you believe are compensable, including study 

tiUe, date of submission to US EPA, and US EPA MRIO number. 

If no response IS received witnin 60 days, Stoller Enterprises. Inc. will understand that no 

compensation is requesled by Helena Chemical Co. 

Sincerely, 

k~ Leanna SmiUl 

Regulalory Manager 

173 
• 

• 

November 28. 2005 

Grow More Inc. 

C/o RegWest Co. 

3085e Rocky Rd. 

Greeley. CO 80831 

c$S 

Stoller EnterpriSDI. Inc . • ..-"<!I,,. ..... :.,w 

4001 W. s.m _ Pkwy, N.,""" 100 I _, T)( n043 

Phone: 113461-1493 I FAX: 7134614467 I 'NWW'.StoflarUSA.can 

RE: Offer-T<rPay compensation for citation of data, indole-3-butyric acid 

Stoller Enterprises, Inc. Intends to apply to US EPA ror registration of a technical indole-3-

butyric acid product using the ·cite-aU"' method of data compensation. The name of your 

company was listed in the US EPA Data Submitters Ust as having supplied relevant data to US 

EPA to support at least one registration of a f'I'IMufacturing-use Indole-3-hutyric acid product. 

Accordingly, Stofler Enterprises hereby offers to pay compensation to Grow More Inc.. 10 the 

extent required under FIFRA § 3(c)(lXD). for citation of aU data in the Agency's filM that (1) 

concern the properties or effects of this product or an identical or substantially similar product; 

and (2) are a type of data that would be required to be submitted under the data requirements in 

effect on the date of approval of this appficatiOn if the application sought the initial registration of 

a product of identical or similar composition end uses. Stoller Enterprises offers to commence 

negotialion to determine the amount and terms of compensation due, if any. for the subject 

studies . 

Pleose note lhat. as required by FIFRA 3(cXl)(D).the p", .. nt offer i.limited to genetic data 

supporting tochnlcsl or manufDCturing-uH indole-3-butyric acid, and not related 10 any productspecific data which may have been proYided to US EPA by Grow More Inc. to support only .ndUM" products. 

If Grow More Inc. delennines that compensation 1$ duo. please respond to the undngned 

within 60 days of receipt of this fetter. In this event. In order to facilitate discussions. pfease also 

Hst the SpecifIC data that you beneve are compensable, Including study liU., date of submission 

10 US EPA. and US EPA MRIO number. 

Ir no response i8 received within 60 days. Stoller Enterprises. Inc, win understand that no 

compensation is requested by Grow More Inc. 

Sincerely, 

~~ Lemma Smllh 

Regulatory Manager 

174 

TECHNICAlINDOlE-3·BUTYRIC ACID 

(IBA) 

Plant Growth Regulator 

FOR MANUFACTURING USE ONL Y 

ACTIVE INGREDIENT: 

Indole-3-butyric acid 

OTHER INGREDIENTS: 

TOTAL 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

.... . .. • • ...... . • 

•• • 

• '" 

· .. ' . .. · · . . •• .. • 

99.0',1, 

~% • 

100.1)%' • •• 

• 

• 

• • 

•••• 

• · .. · .. • .. • • 

• ;-I----~ 

• -~~-;d--~Ye :~~;!n~l~nse-s·lowfy -an:'-'-~'~ntIY Wi~h water for "15~2ir"1 

• 

If in eyes 

'--H on skin or clothing 

minutes I 

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

continue rinsing eye 

__ ,C_C!!I a pOison control center or QQ,C::.toLf0 treatment advice. '~_M __ ~~ 

wash exposed skin with soap and water If irritation persists get 

medical attention. Remove heavily contaminated clothing and ! 

launder before fe-use, 

! HOTLINE NUMBER 

'I Have the prOduct contamer or label with you when calling a poison control center or doctor. or going 

I

' for treatment. In case of emergency_ call the National Pesticide Information Center at 1-800-858-

7378. n_" __ ~_~_~ ___ _ 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS 

Caution 

Causes substantial but temporary eye irritation Avoid contact with eyes. May cause skin irritation. 

Avoid contact with skin In case of contact. wash thoroughly with soap and water after handling. 

ENVIRONMENTAL HAZARDS 

00 not discharge effluent contam'lng 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 permitllng authority has been notified in wnting 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 

Do not contaminate water when disposing of equipment washwaters or rinsate 

EPA Reg. No. 57538·XX 

EPA Est. No. 82046·CHN·1 

NET WEIGHT 

XXXXXXXXX 

date code 

. 

Manufactured for 

Stoller Enterprises, Inc. 

4001 W Sam Houston Pkwy N, Ste 100 

Houston, Texas 77043 

713·461·1493 

www.keyJate.com 

176 
• 

DIRECTIONS FOR USE 

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

For manufacturing use only. This product is intended only for formulation into the following 

plant growth regulator end-use products for: 

t) Terrestrial food uses on barley (cereal grain), beans (blackeyed peas. southern peas, dry. navy, 

snap), broccoli, Brussels sprouts, cabbage, cauliflower, citrus fruits. cotton, corn (field, sweet. grain). 

cucumbers, lettuce, melons. mustard (teafy. stem crop), mustard cabbage (pak ChOI), oats (cereal grain), 

onions (green, bulb), peanuts. peas, peppers, potatoes (white, Irish), rice, rye (cereal grain), sorghum. 

soybeans. spinach. squash (summer, winter. zucchini). strawberries, sugar beets (sugar crop), sugar 

cane (sugar crop), tomatoes, turnips, wheat (cereal grain). 

2} Terrestrial non-food uses on ornamental herbaceous plants, ornamental woody shrubs and vines, 

ornamental or shade Irees. golf course turf (greens, tees, fairways and rough). ornamental lawns, & turf. 

3) Uses for which US EPA has accepted the required data or citations of data that the formulator has 

submitted in support of registration 

4) Uses for experimental purposes that are in compliance with US EPA requirements. 

Each formulator is responsible for obtaining EPA registration for its own end-use product(s). 

For general product 'Information, call Stoller Enterprises Inc. a1 800-539-5283 between the hours of 9 

a,m and 4 pm Central Standard Time 

STORAGE AND DISPOSAL 

Do not conlaminate water, food or feed by storage or disposal 

PEST!CIDE STORAGE: Keep containers tightly closed when not In use. Store in original container 

away from food, feed. fertilizers or other pesticides. 

PESTICIDE DISPOSAL: Wastes resulting from the use of this product must be disposed of on site or at 

• an approved waste disposal facility. 

CONTAINER D!SPOSAL: Completely empty bag into manufacturing equipment. Then dispose of 

empty bag in a sanitary landfilL or by incrneration, or, if allowed by State and local aulhontles, by 

burning If burned, stay out of smoke 

WARRANTY STATEMENT 

To the fullest extent permitted by law, neither the manufacturers nor the seller make any warranty, 

expressed or implied, concerning the use of Ihis product other than indicated on the label. Buyer 

assumes all risk of use of thiS material when such use is contrary to labelmstructions, Read and follow 

the label directions carefully, 

177 
Pages 178-181-*Confidential Statement of Formula may be entitled to confidential treatment*
o 0 

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o 

o 00 

o 0 0 

00 0 

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182