# EPA Registration Jacket 57538-27

# A:r:o JUL 27 2006

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# '150 1-1IO APR 5 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}'ricAcid EPA RegistrationNo. 57538-27 

### Fonnulation Amendment to Add an Alternate Fonnulation Containing an Alternate Source ofIBA 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 ofyour product under FIFRA section 3(c){5) when the Agency requires all 

### registrants ofsimilarproducts to submit such data. 

### Ifthese conditions are not complied with, 

### the registration will be 

### subject to canceIJation in accordance 

### with FIFRA 

### section 6(e). Yourrelease 

### for shipment ofthe 

### product bearing the amended product constitutes acceptance ofthese conditions. Ifyou 

### 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)**

# •

• 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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# • 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, CASRK 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 (PYI) 

### Biochemical Pesticides Branch 

### TO: Chris Pfeifer. 

### RAL 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 04670I, 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 ofthe 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 oflive 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 

# 6

# •



# • 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 selfproposed certified limits of



### 3. The application for registJ<ltioil ofthe 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 ofData 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: 

# •

• •

• In Atladnnent 

### A: All the laboratory records for weightings 

### and preparatil)U5 ofsolutions from the retcrcnce standlmis and Ihc technical prodncts. propcrtks ofthe relctenee substances and certificates 

### of ;]I1alysis.: In Atlad1l1H!nt B: List oj"**CDdL'~** 

### It)r cmn:ctI(ln orditlcrcnt types oferrors: In Attachment 

### C: All the receipts from shipping and storing the samples and records orthe**sttlra~'.tc** 

### conditions ( temperature, humidity); In Appendix D: Oetailcd description ofthe analytical procedure including Idcntiflcilttnn ofthe chemicals, the equipment, conditions of chnlIlUltographic separalion and mode ofcalculations:



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• •

•



## •

• hI Attachment E: All the raw data. chromntuh'TamS and results froll! the estimation ofthe precision ofthe 

### 3naiy1icai**il1cthQd~** 

### In Attachment F: All the mw data. chrumatograms and results from the estimation ofthe accuracy ofthe 

### 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
.

1 

# 8

# BASIC CHECK LIST FOR CONFIDENTIAL STATEMENT OF FORMULAS (CSF) Please note that 

### ifyou have any questions at any point, especially with chemical ormicrobial names, consult with a chemist! product characterization scientist. (Freshteh, Paul, Russ, Carl, Michael T. W. orChris). It

### may be helpful to make a copy ofthe CSF for marlring comments, questions, and needed corrections. Upon completion ofthis 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


# • 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 thaIwhen the PPCV system is functioning agaill most of this infomwtionjor 

### 7-12 C(lll 

### be obtainedon-line. Some of the codes may be listed onprior 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 ofZubkoffor 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. Foreach 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/hisproduct is for feed 

### or/ood Ilse, 

### all inert ingredients MUSThave 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 ofthe 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 of40 CFR pages 2%-300, or the pesticide petition 

### filejacket) !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 Calculateupper and lower limits using table above and compare

### with those listed in colunans 14 

### a. and 14 b. ofsubmitted CSF. Ifthey do not agree, identifydiffcrencc(s): The registrant has proposedbroader limits for which is classified as an impurity. This has been 

# e reviewed and found acceptable. 14. Does the sum ofthe 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. IfAlternative 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



# 10

# •



# • DATAEVALUATION RECORD INDOLE-3-BUTYRlC ACJD (TECHNICAL fl\'DOLE-3-BUTYRlC ACID)
STUDY TYPES: ProductIdentity and Composition (OPPTS 830.1550) Description ofBeginningMaterials (OPPTS 830.1600) 

### Description ofFormulation

### Process (OPPTS 830.1650) Discussion ofFormation oflmpurities (OPPTS 830.1670) Preliminary Analysis (OPPI'S 830.1700)



### Primary Reviewer:Certified Limits 

### (0PPTS 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 ofPesticide 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: SylviaMilanez, 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 mayhave 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.** 

# 11

# •

• 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 orBeginning Materials (OPPTS 830.1600) Description ofFornlUlation Proccss (OPPTS 830.1650) Discussion ofFormation ofImpurities (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 ofAnalytical Methodology for the Assay of Indole-3-Buty ric Acid and Process-Related Significant ImplIfitics ofIndole-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 ofTeehnical 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 ofIndole-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

# •

• 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 offonnulation process, and lhe physical and chemical characteristics werenot addressed andpresumably 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. 

### PRODUCTlDE:>iTITY A:>iD COMPOSITIO]\': 

### Technicallndolc-3-Butyric Acid (EPA 

### Rcg Ko. 57538-27) 

### is amanufacturing-use product**(~P)** 

### and aplantgrowthregulator. The regislrant wishes lo add an alternate producer ofTechnical Indole-3-Butyric Acid. The active ingredient in the alternate sourcematerial 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 OFBEGII\l\"ING MATERIALS: 

### Kol addressed andpresumably 

### will bebridged 

### from the 

### data for the 

### rehJistered product. III. DESCRIPTION OF FORM.ULATION PROCESS: 

### }lot addressed and presumablywill be 

### bridged from the data for the registered product. IV. DISCUSSION OFFORMATION OFTMPURll'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

# • 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 jowerand upper certified limits ofthe 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

# •

• U.S.EPA/OPP Pesticide·Related Database Queries· NPIRS Page 1of 2

Home Aboul Services Meetings PPlS Stale links Subscribe Coniact



### Product Repon

Number ofSelected 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'KIVY N. SLITE IO() IIOUSTON 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 ofthe 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

## '" 0

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.. ','H5 United 51.tot 

### Environmental Protection Agency Washington, DC 204&0

### ' 

### Registration ,f 

### Amendment 

### Other oPP Id.ntifl.t Nl/mber 

# oEPA

,- , I 3,**Pr~o.od** Classification 1.**Comp~nylPfoduct** Number 57538,27 

### T; i ,;

### :_~_':.:~, j 2. EPA Product M8n11qllr OL Shery' Reilly 

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# 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



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# [J Othef· Ex-pillin below.**I='----~---~---·-** 

### - ............... -..**-~--"==--~-~~--~-~~_____I** Explanation: Use additienel peoe!
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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
...

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46864901 

# • )lfice 'Wa(f(gr, Pfi/D. REGULATORY CONSUL71NG • 3094 COUNTNr CLUB ROAD· SS,\'ATUBlA, MS 38668



### JlIue 

### 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 

# orPreliminary**A.J)alysis/5~Batch** 

### A!>say, OPPl8 830.1700. 830.1750, and 830.1800
. 

### We have al!>o enelosed 

### acopy 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. Ifyou 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

# •

• OAKRIDGENA1'IONAL

# LABORATORY MANAGED BY UT-BATTElLE**FC~** THE DEPARTMfNT OF ENERGY August 30, 2006 CUSTODY RECEIPTFORFIFRA CONFIDENTIAL BUSINESS INFORMATION 

### , TO: PamelaLandis Biopesticides and Pollution Prevention**Divi~ion** Office ofPesticidePrograms U.S. Envirorunental Protection Agency One Potomac Yard 2777 South Crystal Drive Arlin 

### on, VA 22202 INSTRUCTIONS, 

### FROM: R. 

### H. RoSi, 

### Group Leader Toxicologyand Hazard Assessment Group 1060 CommercePark OakRidge, Tennessee 37830 (865) 574-7797 FAX (865) 574-5353 email rossrh@oml.gov

1. Original ofthis receipt to be signed

### by-recjpien~ and returned to sender. 2. Duplicate ofthi!! receipt to be retained byrecipient.

Hours TASK 

# ,

No. MRfDNo. Chemical!Agent WAM . Material Sent Status 

### "'!. Actual 0&.08& 46864901 Indole--l.Butyric Acid Landis IDllR Dmft 30 20 1Study ICD 1CuslOdy Sheet

Ihave**P,tr;s~ally** reteiveO from,the sender material.**encl~.lInd** II.ttachmetltsas identified above. 1assume full fCsponslbiltly for thesafe handlm Storage, dtransmittal ofthis ma.lcrial in accordince with existingFIFRA 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.



# 19Page 2

p. 4flfW1901 (2008) Validation ofAnalytical Molhodology lorthe 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

. 

# •

•

20forlll**Allpr~'v**....1OMit '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 ofinforrru.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 orthis 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 31eXIIJtf)**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.:': 

# WhlL**~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:fro;':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: \)fIIny 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 ofAna!ysis for Comp! 1<lIlCe 

### witl! PH. :\Io(lte**S6~5** 

### Thank you 

### illr your submittal**of20-JU:\l~O(),** 

### Our staffhas 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 ofyour 

### 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. Ifyou 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'rli\

# (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 orRegistration 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 CompanyNumber: 57538 Company Name: STOLLER ENTERPRISES, INC LEANNA SMITH STOLLER ENTERPRISES, INC 4001 W. SAM HOUSTON PKWY N, SUITE 100 • HOUSTON, TX 77043



# • SUBJECT: Receipt ofAmendment and 100% Small Business Waiver Request Dear Registranl: 

### The Office ofPesticide 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 orPesticide Programs has dctennined that this Action is subject to a Pesticide Registration ServiceFee as defined in the Pesticide Registration Improvement Act. 

### TheAction

### 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 benotified in 

### writing when a detennination 

### is made regarding your request. Ifthe determination indicates that payment 

### is due, you 

### will receive instructions for submitting payment 

### at that time. Ifyou 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 ofcheckhsts? 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)'- 

# ii 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 

### (ifany): 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 forjacket one X 6/13/06 for FOIA (EPA Form 

### 8570·35) supports method ofsupport? reflects information reported in transmittal document and

### ~':.::I~Y cover letter? :::ulator'sexemption form (EPA Aba Comments 

## ent

·Amendment Application is for adding an alternate source ofAI 

### -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 

### iffood Exempt from requirement of tolerance or exemption/amended food tolerance for agricultural tolerance orexemption commodity use petition# assigned? petition jacket included? petition complete w'lth secflons A-G? note all comments - 

### ifthere is not evidence ofa petition 

### # assigned and secl A-G not**Dreoen~** 

### packa•• fails. 

# •

FR template 

### iffood 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 newtolerance 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 Respectto 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, 

### ifapplicab!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 DATA 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 MR!Dli468649*O I

y Cit!:a!1 y


# 33Tiel' ITnxicit (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 INon-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·'1argcllnsecls

, 

# 34crobials 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: .tarequirement 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 ofan alternllte source ofAT. Preliminary analysis data is submitted in this package.



# 36

----------------------------------------- ------ ---------, --,--.----**--~,....-----"------- 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< (IfillfwlIIJliltfi**fUIlli>h~u** ll}**Ih~** (cgHltJ!ll, Ihe**~oo\'e l\Jm~tl** **pe'II~,J<:** I, lIel\'])Y 1"jii.slncdlrcr,-gl$lef;:t! IIntlerlhe feuer.J.IIIISI'Clldde,**I~unl'ieide** "lid R,>..\ehlid<k ""{**Rep~lratiOlI** 1$ ;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**  "rJ**J'I.~IIc;d~** Inan:<.'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 cOllditions.: 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'**



# .. lib 

# ).v-i{/f£ Y' 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: •••••• • 

### • •



# ......"
................................., ......, ... :•••• :**99.~,.J'·:·** Indo!e·3-bulyric acid 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, ifthese arc not available, drink a large quantity of 

### wnter. Avoid alcohol. • Call a poison control center ordoctor 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, golfcourse 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 iI1grcdicl1[, 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 ofa new source or**[cchnicallndoJe·3~bu[yrk** 

### acid (lEA) (EPA Reg. 5753S-ET), containing 99,0 q:, wi\\' 

### ae[ive 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 orimpurities 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

# •

•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 I33_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/1 lh1c 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

# •

• 3
TAHt..£ 2.**l)by!\if~11** nnd Chemicilll'ropcrlh'Sfor 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,\ Ior MP S31J 7300 Blilk Den"ll' 6:U; Ihitl! 8]0.7:)70**Dl~!>1.J(iatll)1I** C(lU,ta11l 

### mWall;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 QfMl' 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 ofIBA 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 ofthe analytical instrument was 0.0312% and the accuracy ofthe 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 orthis new TG;\I is pro\,ided in the MSDS for



# 98

# •

• UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D,C, 2046(}



### MEMORAN!)UM 

## MAR 02 2008

SUBJECT: Review ofProduct Chemistry Studies, MRIDs 46708301, 46708302 and 46708303, supporting registration ofnew source oftechnical 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, !)ecisionNo. 326839, FROM:

THROUGH: Clara Fuentes, Ph.D., Biologist Biochemical Pesticides Branch Biopcsricides 

### & Pollution Prevention Division (7511C)**/'~)** 

### , 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!) 

### StollerE1IIerprises. /tIC, 

### is submitting copies ofthe CSF, summary ofphysical-chemical properties (Description ofthe Production Process, MRID 46708302; Discussion ofFormation of Impurities, MRID 46708301; and Validation ofAnalyrical Methods. MRID 46708303) and draft label for registration of

### a new source oftechnical 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\'DAnONS AN!) CONCLUSIONS The submitted product chemistry data are unacceptablebut upgradcable. 

### Toupgrade 

### 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!nMen**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 ofa 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 % 

### ofthe 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 

### ofthe same active ingredient.


### STUDY SUMMARY PRODUCT CHEYllSTRY PmdUCI chemistry and composition: 

### Deficiencies: 111t! CAS !\o. ofthe 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

# •

• J


### 'CONTAINS CONFIDENTIAL BUSINESS INFORMATION'

TABLE I. 

### Nomina) CSFconcentrations 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 (Guidcline, \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 ofResnil 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-DutyricAdd" Guidl'linc Itl'ferenee No. Proprrlv l)c;<;eriplilln orResult 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 UfMP 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 ofTechnical 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 ofstarting 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 oflEA 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 ofthe ;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 % 

### ofthe same active ingreuient, and address first aid and 

# 102

# •

• 5 precautionary statements for oral roule 

### ofexposure <IS 

### stated 011 

### label or 

### referenced product, EPA No, 72639a 

### 1. containing a lower concentration ofsame active ingredient, 98%**Indolea3~** 

### butyric acid
.



# 103

# • II/lernalBBPD Gllium/ccDocI/mcllt· OtherItems 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 If3mendment. indicate type: label. CSF or both: RegisJmtion Ifamendment. is change covered 

### hy PH. Notic!.! 

### 98· I () (Notil1l:atiolls)? YESD NOD NA 0 IfYes. 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" IfNO, 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 ofPRATS (label defio.:icncy). Exceplions \() Illis pr;K'IlCc '::JllllCCllL 3,**Confiq~mial** St:lkmellt ofFOrl1!.ul'! (EPA form 8570-.1) a) Completely filled Ollt inciudhIg pH, fiashpoinl. flammability, etc. ifapplicable. 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? (IfNO, 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
.. IfYES, 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 

# 104d) 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 ofData YES 0" NO 0 (EPA Form 8570-34) (Sec 40CFR 152.80-98 ami PR Notice 9:-:l·5) Ifno data are required or submitted. the Certification need not be submitted. This is often tOle for minor 'ImendllleIllS. Il) Did applicant check il method ofsupport? 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 Priqrto Registration (Required per 40 CFRI52. I 16. sepamtc from permission ofan exclusive use data submitter to rely on exclusive use data) Is tltis au exclusive use aj. orcombinntion ofactive ingredients (registered within last 

### 10 years)? IfYES. go to a) or b) below. <I) 

### Has a notification letter oremail 

### been senl to tlte exclusive use data sllbnutter(s) allea.<:t 

### 3D days before regislration'! (TIlis notification is required for 

### all methods ofdata 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 ofeOlllpliam::e? b) 

### Has registrant submitted certification from exclusive lISe d.l!i1 submitter that submitter 

### is aware ofapplication 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 efficacydata examined for lahcling. c) Nominal concentration ofa,!. listed in ingredients statcmcnt d) Storage and disposal iustructions Ilgrcc with containerIYIICS !isted 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 ifyou have**~Iny** 

### questions at Clny 

### point, cspeci<tlly with chemica! ormicrobiul 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 ofthe 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 uMaterial 

### Suicty Datu Sheet 

### CvlSDS) for eaeh new ingredient'! 

# o yes lino Detlciencies: NA. MSDS 

### alrcudy on file. 

### Please Jlote thm witCH die PPCVS)'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 ofZubkoffor 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) 

### fIlMsproduct 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 ofIhe 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. 

### Ifproduct used on food or feed, confirm aetive ingrediellt(s) has <1n established tQlenmee or exemption from food tolerance. (Consult Alphabctieallbting in 

### pmt 180 

### of40 CFR pages 296-300, or the pesticide petition filejacket) 

### 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',.!m tl • • 

### 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. 

### ofsubmitted 

### CSr. Ifthe), 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 ofthe 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. 

### IfAlternative 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

# •

• 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 

### PrecauUonaryStatements 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

### Directionsfor 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 

### Directionsfor 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 ormisleading 

# ,**'~I11C** warrantyscction contains an IIverlybroad statement concerning limitations oflinbility, As such, this statement may bemisleading andmay constilUte llIisbrallding underthe Fedemllns('cticid(', Fungicide nlld RodenticideAct (F1FRA), It is sugg('$1ed thatthe existing statcmeutbe prl'ceded by thephrll5e,**~to** the extent allowableby statelaw", orothetwise qualified to make it ciearthat this warranty is not intended to bl:' a st1tementoflawwhich implies thatthe buyer has no Icgal rights to l-ecoverdamages from the manufacturer if be/shesuffcred n loss orinjury from the product and concludes that

### it would be futl!e to pmslIe what ntight in realitybe a "aHd claim," 

# 109ROUTING &: l'R,\NSMITT\L SLIP 

### " 

## , , M h 16 2006 arc 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 ForCOfrC>.'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: SlOlIerEn1erprises. 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 ofthe Registriltion Kotice (1 for concurrence) 2) L+lhcls: Highlighted, Fillnl and Substantially Similaf 

### "'\it':SF

.iJ'-Rc"icws: LJpgradenble 10 Acceptabl¢ • Clwcklisls: Old AI. CSFmld [)(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 

### IUn,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** 

# I'**.J~.-** lltb
..t ______ 

## I _**COnr"jM~**_______ H:<J 1()I'g 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 ofthe 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 ofthe product as 'substantialfy similar" to currenUy registered products, and documentation ofthe 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 ofthis is also attached. I trust the submission is correctly fonnatted and assembled, and the cite-aU method ofsuppoprt 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 ofthat box i.e. "Companyf 

### Product (Name)" 

### The registra1ion c.kx.'1lmcl1ts shmJid come to me. I will keep copies: 

### roc my files and send on to Stoller
. 1attach 

### u fomlul 

### COITcclion with regard 10 the 

### The "Summary ofthe 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

# •

• 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 ofapplication 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 •••••

# •

• 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 

## • • 

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• 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 oferror. 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

# •



# •

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

### ---------------- -



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


### The descriptive Inform;1.tion in this 

### repon is not sU!1iccr to the requirements of40 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 

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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

___ IOP,'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, t200IDoscriplion 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 oftndole-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. t7SO/Certified limits Indole-3·Butync Acid and Process-Relatoo Significant Impurities of Indole-3-Blltync Acid and Subsequent 5·8atch Analysis 01 Indole·3·ButyricAcid 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,

# ~.. 

# 140Pilgtl2 (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-ButyricAcid TGAI: Finnl Report Projecl Number: MKl0410124. UnpHblishiid study prepared by McKenzleNJrlght LaOOr:l.1orios.llC, 361 p 

# •

• a80.I400iDiscussion offormation 830.1700fPreliminary analysis

83O.175OfCerlifled liml1s

83O.laOOJEnlorcementllMlyticll ll



# 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 ofnew 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). DPBtncodc: 326839; 

### Decision No. 326.839.**-~.--~** 

# rz-**(~ ---~**  FROM: Ci<lra Fuentes, Ph.D., illologist**~~ ~**  

### 13iuchemical Pesticides 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 IC)


### ACTION REQUESTED Stoller EllfCIlJrises, 

### fnc. is submitting copies orthe 

# csr, summary of**physical~chemical** 

### properties (Descriptioll orthe Production Process, 

### MRID 46708302; Disclission 

### ofFormation 

### of Impurities, MRID 46708301; 

### and V:llidJlion orAnalytical Methods. MRID 46708303) 

### nnd draft lubel for registration 

### of 11 

### new source 

### oftcehnical**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 04670I). 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 ofa 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 % 

### ofthe 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 

### % ofthe S<lme tlctive ingredient.
STUDY SUMMAI{Y 

### PRODUCT CHEM1STRY Product chemistry '!..f1iLcomposition: Deficiencies: The CAS No. ofthe 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 offormatiOl'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 ofthc
. Prelinlinaryanalysis: Deficiencies: None Certified limits: Deficiencies: None.


# 143

# •

• *CONTAINS CONFIDENTIAL BUSINESS INFORMATlON*


### TABLE 1. 

### Nominal ('SFconcentrations 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 }Crlv 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 Ih 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

# •



# • 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 uraround 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 fnrTGAfor 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"cntlyregistered MP, (EPANo. 72639- I). 

### which contains 98% IDA. The label is consistent with the CSF concerning the active ingredient. The description ofstarting 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 ofIDA 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 ofthe analytical instrument was 0.03J

### 2% and the accuracy ofthe analytical mcthod was 100.52% with a slight positivc bias of0.436%. 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 % ofthe same active ingrcdient. and addrcss first aid and 

# 145

# ..



# •



# • 5 precautionary statements for oral route ofexposure as stated on label 

# orreferenced product, 

### EPA No.**726~9~1,** 

### containing a lower concentration ofsame 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 

# NO(S). :



# P11: ql


# --------------------------------**CHE~lICAL ~O.:**  

# ---------

Thejacket 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

: : • - r n

- --- -----. 

# IDate 

# I
: 

## I**~~.~~---~~~~-.-.** Abae 

### nt Comments

11/30/0 I 

### -Application (me-IOO) is for a new source of Techhii::allBA 

### 5 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

...**~**...**~~~~~~~~-~~~-**".---**--~~-.----~**

### --------- AdminM

### aterials



### - Formula 

### form 

### 85tor's exemption form {EPA 70-27) 

### Transmittalletters 

### 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 • petition# assigned? • p

### etition jacket included? 

# •**~** etition complete with sections *G? 

### • nate all comments - 

### if there is 

### n 

# • _Eot evidence of a petition # ssigned and sect. A-G not resent. oockaae falls. late 

### if food tolerance or 

### FA temp exemptio exemptio

### nlamended food tolerance or n 

### • n olice of filing template (disk) ineluded?

ote all comments· a NOF 

### • n must 

### be present to establish 

# • new tolerance exemption

. 

# • Amendments to an existing 

### to In

### I. petition may be Agency

IllRled In which case a NOF 

### w p would not expected to be

resent. (If unsure, check ith branch team leader) 

### • component 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


### • 

### • ore than one active? m 

### are all actives housed in BPPD?

__N ____ 

### ---------- 

# , 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

### Admin Malerials Signed Dale ....................**~~~. ~** ..........**m~~~~~** _ 

### ntifyingSymbol

.. Jacket from EPA Ide 

### Are MRIDS assigned comments) 

### ? (State Yes/No in

--- -------------- ental Use Permit 

### Background Experim information, 

### if applicable mporary tol. 

### • request for te exempt, toL e numeric tolerxempllon 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 

### I n

.. 

### 57538·ET Y Comments



# 150

### CHECKLIST FOR DATA PACKAGE SCmNCE SCIlliEN Active Ingn..>dients: Indole M 

### 3 M

### butyric 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 

### eBm,,' 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 oflheFnrmalinn of Y Stndy :-.uhmincd In**MRI1J~4670S3·02** Preliminary Analysis N SlUdy sllbmilled 'm MRJD#4671183-OJ Cr:rtifiecl Limits Y 

# IStudy 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) 

# INOI",9S-1
- Tier I ilJ{)katc in Comments irwaivcr.- 

# , 

# 151AcuteOrnl 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 " 

# Iol\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 ifwaiver s.ubmhted)**A~'i;m** Aente Oral Avilln Acute Dietar:.' frcslt\vater Fish LC50 Frcshwntcr**ln~'crtchratc** I.C50 Non-larget Plllnts

'.J'" 

### ""1;'" Ins.ws }IoneybceTesting 

### I,," voo1v)


# 152Other 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 

### ifrequired 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!**~** 

# 4ftJ;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 EliI 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~~_** IVA# 

## 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 ofchecklists? 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 ofAnalysis 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? nvolpay % 

# 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 PAYMENT 

## 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 ofPesticide Progl'ums has recc1VCU your application for registration and 50% 5111all business**wain~r** 

### reqllest. 

### Ifyou submitted data \\<lIh this application, the results 

### ofthe**PRN~86-5** 

### screen will be cOillmlluicatcd separately, During the ndlllinis(rative Screen. the Office ofPesticiJe 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-:-FAS'!' 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. Ifyour waiver request is approved, Ihe decision review time' period will start 011 either the date ofapproval or the receipt orpayment, whichever is la!i!c Ifyou wOllld likl.! (0 

### avoid delaying Ihe start date. YOII 

### may pay the amount listed below at this lime. Ifyom 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: USEPA 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 ofthe Environmental Protection Agency. Tn ellsme proper credit, please write the OPP DECISIO;-"; 

### NtJ\fBER on yourcheck. and enclose a copy ofthis 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 ofthis 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** 

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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

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# •
• 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 notethat the SDTF, OAETF, and AATF 

### are noted as data submitters. However, their data are not required for this :•••:. application 

### at this time since EPAwaived requirements for worker exposure olwe. 

### to the low toxicity of the product. : •••• •••••• • 

### • 

## •• 

## • • • ••••• 

## • •

•• 

## ••••• • • 

# ..**~**

# .. •••• • 

## •

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### • • •

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### ••• • •



### •• •



# 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 ofdata,**Indole~g..butyric** acid 

### Siolier Enterprises, Inc. Intends to apply

### to US EPA for 

### regisltatioo ofa technical indole.3- bulyric acid product using the 

### 'clte-alr method ofdata 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 SAde 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 ofthis product or an identical or.sub$lantially sfmllar product; and (2) are a type ofdats that wouJd be 

### required to 

### be submiHed underthe data requirements In effect on the date of approval ofUlis application 

### Ifthe appUeation sought the initial regisbatioo of 

### a product of

### identical orsimilar romposition and uses. Stollet Enterprises 

### offers to commence negotiation to detennine the amount and terms ofcompensaHon due. 

### ifany. for the subjact studies. 

### Pl

....note**the~**

# .s required 

### by FIFRA 3{c){1){O), the 

### present offer i. limlted 

### 10 

### geMricdata 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 

### ofthis letter. In this event, in 

### order

### to facilitate discussiOOS, 

### pte
....aloo list the specific 

### d8ta that you be1ieve are compensable, inQuding study title, date 

### ofsubmission 

### 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 ofdata, indole-3-butyric acid


# • Sioller Enlerprises, Inc. intends to apply

### to US EPA klr registration ofa technk;al incfoIe-3- butyric acid product using tho ·cite-alI" method of dala compensaUon. The name ofyour 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 herebyoffers to pay compensation 

### to AgricerG Inc.. to the extent ,,",uired under FIFRA 

### § 3{c)(1)(O), for citation ofall data in 

### the Agency's fiies that (1) concern 

### the properties or effects ofthis product or an identical or substantiaHv similar product; and (2) are a 

### type of data that would be required to be submitted under 1Mdata requirements In effect on the dateofapproval ofthis appUcation ifthe eppllcaHon sought the initial registration of a product ofkfentical or similarcomposition and uses. Stoller Enterprises offers to commence negotiation to delermine the amount and terms ofcompensation due, if any, for the subject studies. Please note

### that. as required by FIFRA 3(cXt}(D). the 

### prtl$OOt offer is limited to gtlllfIric data supporting t9Chnlca/ormanufBC'Itlrin!ruse IndoJe-3-butyric acid, and not refated 

### to any productspecific data which may have bean provided to US EPA byAgrIcaI'9 Inc. to support only enduse products. IfAgricare Inc. determinesthatcompensation isdue,p'0ase respond to the underslgnedwithin 

### 60 days 

## ot receipt ofthis letter. In this event. in orderto facilitate discussions. 

### please also list the: specific data Ihat you beflsve am compensable, Including study IiUe, date ofsubmission 

### 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 byAgricaf$ Inc.

# ~~ leanna Smith Regulatory Manager



# 167

# ~ StollerEnterprises, 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



# • StollerEnterprises, Inc. intends 

### to apply 

### to US EPA for registration of a technical indole-3. butyric acid pnxlucl using the**~cite-alr** method ofdata compensation. The name ofyour companywas listed In the US EPA Data Submittern Usl 8S having supplied relevant dafa to US EPA to support at least one registration ofa manufacturing-use indole-3-butyrlc acid product. Accordingly, Stoller Enterprises herebyotfer& 

### to pay compensation to C & R Products, to the exlenl requlned und.r FIFRA

### § 3{cXl){D). for citation ofall data in Ihe Agency's 

### files that (1) 

### concern the 

### properties or effecta: of

### this product or an tdenUcaI orsubstantially similar product; and (2) are a type ofdata thai would bo required 

### to be submitted under the data requirements in effeet on 

### the <:tate ofapproval ofthis application Ifthe application &Ought the fnftJal registration of a product of identkal or similarcomposition and uses. Stoller Enterprises offers to commence negotiation

### to detennine the amount and tenos of compensation due. ifany, (orthe subject sludies. Please note tnal. as required by FIFRA 3(cX1XO}, the present offer is fimHed 

### to generic data supporting technical ormanufacturing-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, IfC & R Products determines thot compensation is due, please respond to the urlder5fgned within 60days of receipt of

### this letler. In this event. in order

### to factllta1e diSCUssions. please also listthe specific data thai you believe are compensable. including studytitle. dale ofsubmission 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 StollerEnterprises, 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 ofdata,**indofe~3..butyric** acid SImler Enterprises, 

### Inc, intends to apply to US EPA for reglslrallon ofa technical indole-3- butyric acid product using the ·cite..alt method ofdata 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 ofa**manufacturlng~use j~e--3-butyric**  acid product Accordingly, Stoller Enterprises hembyoffers 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 oreffects ofthts produet or an Identical or substantially similarproduct; and (2) are 0 type ofdata that woukf be required to be submitted under

### the data requirements in otf&ct on the date ofapproval ofthis appHcation Iftho application soughl the initial registration of a product ofidentical orsimilar composition and uses. Stoner Enterprises offers to commence negotiation to detennine the amount and terms or compensation due, If any. forthe subject sludles

. Please note that. as required by FIFRA 3(c)(1)(D). 

### the present offer ISl:imited to generic data supporting t&ehnlcal ormsnufacturlng--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 FertilizerCorp. delermines thai compensation 

### Is due. please re5pOl1(f to Ihe undersigned within 60 days of receipt ofthis: letter. In this event, in order to facilitate discussions, please also list the specific data that you betleve are compensable, including study title. date ofsubmission 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 ofdata, indoJe..3-butyrlc add Stoller Enterprises, Inc. intends to apply to US EPAfor mgistrnUon ofa technical ind0Je..3.. butyric acid product using the**~cite-an·** method ofdata compensation. The name ofyour company was listed in the US EPA Dala Submitters Ust as having supplied l19levant data to US EPA 10 support at least one registration ofa manufacturing-use indokJ...3-butyric acid product. Acco«.Iingly. S10ller Enterprises herebyoffers 

### to pay compensation to Techniflora Plant Product. ltd
.. to 

### the extont required under FIFRA 

### § 3(c)(1)(0). for**cita~on** ofaN data In 

### the Agencys lIlesthat (1) concern the properties oreffects ofthis product or an i<IonHcaI or substantially similar product; and {2) are a 

### type ofdata that would 

### be required to be submiHed under the data requirements in effect on 

### the date ofapprovaJ ofthis application If

### the application sought the initlat reglstrntlon of 8 product ofldentical or stmllafcomposition and uses. Ston.r Enlerprises offers to commence negotiation to detennlnethe amount and terms of compensa1ion due. ifany. for the subj&ct studies. ?tea.e note that. as required by FIFRA 3{c){1 )(D), the present offer is limited to genedcdata suppor1lng technical 

### ormanuf&cturing-uSfl indole-3-butyrlc 

### add. and no1 ra/ale<! to any productspecific CUlts which may have been provided to US EPAby Techniflora Plant Products Ltd. to support onty end·use products. IfTechniftora Plant Products ltd. determines that compensation is due. please respond to the undersigned within 60days of receipt ofthis letter. In thit event. in ordertofadlttate discussions. please also listthe specific data thatyou beHeve are compensable, including study title, date 

### ofsubmission 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 

### November28, 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 ofdata,**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 ofdata compensation. The name ofyour 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 herebyoffers 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 ofdata lhat would 

### be requfred to be submitted underthe data requirements in effect on the date ofapproval ofthis application ifthe application sought the initial registration

## Qra productof identical 

### or similarcomposition 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 presentoffer is t/mited to generic data supporting technlcsl ormsnufacturing..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 ofthis letter, In this evenl, in ordertofacirrtate discussions, please also 

### Ust the specific datathat youbefteve 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.'" 

### November26.2005
Cytotech Enterprises. Inc. c/o Pyxis Regulatory 

### Co. 4110 136th SI. NW Gig Harbor. WA 98332 

### RE: 

### Offer
..TtrPay compensation (orcitation ofdata, 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 ofdata compensation. The nameofyour 

### company was listed in the US EPA 

### Data Submitters Ustas having suppJied relevant data to US EPA to support at least one registration ofa manufacturing-use indole-3-butyrtc acid product Accordingly. Stoller Enterprises herebyoffers

### to pay compensation to Cytotech Enterprises, 

### Inc.• 

### to the e><tont requilVd under FIFRA 

### § 3(c)(1XD). for citation of

### all data 

### in the Agency's 

### fiI

.. that 

### (1) COflcsm tho properfl.s oreft'e<:ts of

### thl. produ'" oran MonGcal or substantially similar product; and (2) are a type ofdata that would bsrequired 

### to be submitted under 

### the <lata requirements In effect on 

### the date of

### approval 

### ofthis application 

### ifth. application sought 

### tho initial registration 

### of a product ofidenticaJ orsimilar composition and uses. Stollar Enterprises offers to commence negotiation to determine the amount and terms ofoompensation 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 technicalOfmanufacturing-use indohJ..3..butyric;;; acid,and 

### not related to any product

### specific data which 

### may have been provided 

### to US EPA by Cytotech EnIOlpri

... , Inc. 

### to support only end-use products. 

### IfCytotech Enterprlses, 

### Jne. 

### detennfne$ that

### compensation is due, please respond

### to the undersigned within 60 days of receipt ofthis letter. In this event, 

### in ordertofacHitate diSCUSSions, please also listthe specfflcdo:ta that you believe are compensable. including $tudy title. dato ofsubmission 

### 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
StollerEnterprises, Inc. A...-rctn.
....

### c.... 4001 W. Sam _ PIoNy, N., _ 100 

### I _,TX 77043



### _______ -''''''''"'==7,,'
.... c:::',,-'c.:493c:..cI..:.FAJO=-.:· 1"
....**'~** 

### I_:Slol"'-'rU..:.SA"."""=______ _ November28, 2005

Helena Chemical Co. 225 Schilfing Blvd. Suile 300 CollierAUe, TN 38071 RE: Offer-To-Pay compensation (or citation ofdata. indole-3..butyric acid Stoller Enterprises, Inc. Intends to apply to US EPA for registration ofa technical indole-3- butyric acid product usJng the "cite--all" method ofdats compensation, The name ofyour companywas listed In the US EPA Data Submitters list as having supplied relevant date to US EPA to support at least one registration ofa manufacturing-use IndoIe·3-butyric acid product. Accordingly, StoUer E:nterprises herebyoffere to pay compensaUon to Helena Chemical 

### Co., to lhe extenl requlned under FIFRA 

### § 3(cX1XD), for citation ofali data in the Agency's files that (1) concern the properties oreffects ofthis produd oran identical or substanllaUy similar product: and (2) are a type ofdata thatwoukJ be required to be submitted under

### the data requirements in effect on lhe date or approval ofthis application ifthe application sought the initial registration of a product ofidenlicaf Dr similar composition and uses. Stoller Enlerprises offers

### to commence negotialion 10 delermine the amounl and lerms ofcompensatlon due, if any, for the subject studies

. Please nol.**Iha~** as required by FIFRA 3(c)(1XD), the

## pre...rn offer is limiled 10 

### generic data supporting tf1chnic81 ormanuf8Clurlng..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 undersignedwithin 60 days of reooipt of this krifer. In this evanl, In orderto fadlttate discussions, please also list the specific data that you believe are compensable, including study tiUe, date ofsubmission 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
StollerEnterpriSDI. 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 forcitation ofdata, indole-3-butyric acid Stoller Enterprises, Inc. Intends to apply to US EPA ror registration ofa technical indole-3- butyric acid product using the ·cite-aU"' method ofdata compensation. The name ofyour company was listed in the US EPA

### Data Submitters Ust as having supplied relevant data 

### to US EPA to support

### at least one registration ofa f'I'IMufacturing-use Indole-3-hutyric acid product. Accordingly, Stofler Enterprises herebyoffers to paycompensation to Grow More Inc.. 10 the extent required under FIFRA 

### § 3(c)(lXD). for 

### citation ofaU data in the Agency's filM that (1) concern the properties or effects ofthis product or an identical or substantially similar product; 

### and (2) 

### are a type ofdata 

### that would be 

### required to be 

### submitted underthe data requirements in effect onthe date ofapproval ofthis appficatiOn ifthe application sought the initial registration of a product of identical or similar composition end uses. Stoller Enterprises offers to commence negotialion 

### to determine the amountand terms ofcompensation due, 

### ifany. 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 ormanufDCturing-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 ofthis fetter. In this event. In ordertofacilitate discussions. pfease also Hst the SpecifIC data thatyou beneve are compensable, Including study liU., date ofsubmission 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 ONLY 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,



# 177o 0 

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# .... . .., o 0 00 o



### •••• o 

### •••• ••• • o o " •••••• o 0 0 o 0 

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# 182