# EPA Registration 1706-184- .- - -



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### I ?no, • L .**~01Jr** , '-\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

Mr. Claude H. Wolf Nalco Chemical Company One Nalco Center Naperville, II 60563 Dear

### Mr. Wolf: Subject: TX-I0861 EPARegistration No. 1706-184 

### FEB - 1 2001

Your Resubmission Dated September 14,2000 This is in reponse to your resubmission ofrevised label for the subject product. The labeling referred to above submitted in connection with registration under the Federal Insecticide, Fungicide, and Rodenticide Act as amended is acceptable. A stamped copy is enclosed for your records. Ifyou have any questions, please call Marianne Clark at (703) 308-6381.

Robert S. Brennis ProductManager (32) Regulatory Management BranchII Antimicrobial Division (751OC)

CONCURRENCES

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EPA Form 1320-1A(119O) OFFICIAL FILE COPY Printed on Recycled PaperNAL.CO CHEMICAL COMPANY CINE'. NAt.CO CENTER" NAPERVILLe" 'LL'NOIS 80563-1198 c AREA 630·305-1000

Mr. Robert Brennis U.S. Environmental ProtectionAgency Antimicrobial Division (7510W) 410 M. StreetS.W. Washington, D.C. 20460 September 14, 2000

Subject: Registration ofNalco**TX~10861** (1706-184) DearMr. Brennis: Thank you for your letter dated August 30, 2000 in which you concur with our suggested precautionary statements onthe above

- referenced registration. I have made these changes and a copy of the label is enclosed. Please note that for product stewardship reasons Nalco has retained in the precautionary statements the follOWing phrases: "Do not giOt in eyes, on 5kill, or on c1oihing", "Remove and
....'ash contamh<ated clothing before reuse" and "V,lash thoroughly after handling." I have also retained the following phrase, "NOTE TO PHYSICIAN: Probable mucosal damage may contraindicate the use ofgastric lavage. Measures against circulatory shock, respiratory depression and convulsions maybe needed." Your letter also requested Nalco to upgrade the First Aid Statement to include an instruction to telephone a Poison Control Center. 1his is not appropriatefor this product. Nalco has its own7/24emergency response system and toll free number (which appears onthe label). Moreover, the product is used in an industrial setting where MSDS's are available. Thus, there is no purpose to instructing users to call a PCC to requestinfonnation on this or anyindustrial antimicrobialfonnulation. Similarly, this product is used in an industrial setting that includes training and provisions for addressing all chemical exposures, inchlding antimicrobials such as this product. Instructing users to contact a physician for treatment advice is unnecessary. It may also lead to poor advice because products are usually referred to by trade name or active ingredient with which a physician would not routinely be familiar. Therefore this statement would notbe appropriate. We believe the old standardfirst aid statements such as shownbelow and which we wouldlike to add to theproduct label in lieu ofyoursuggestedlanguage from PR Notice 2000-3: IF IN EYFS: Immediatelyflush withplentyofwaterfor at least 15 minutes. Seekmedical attention. IF ON SKIN: Immediately wash with soap and plenty of water. Remove contaminated clothing and wash before reuse. Getmedical attention ifirritationpersists. IF SWALLOWED: Drink large quantities ofwater. DonotinducevOmiting. Seek medical attention immediately. Finaliy, your letter**requ~sied** Nalco add thl":**gen~ral** st&.tement "Ifave the productconrei.'1er or label
....itl.", you ·when you call a PoisonControl Center or doctor or goingfor treatment" Industrial antimicrobial products such as tItis are sold incontainers of atleast5 gallons and morefrequently in retumable totes of450 pounds or more. Labels affixed to these large containers are designed so that they cannotreadily be removed. It is notphYSically possible to carry a tote to the telephone or treatmentlocation, and it would notbe advisable to carry a 5-gallon container. TJiett!fb!e, I haveincluded onthe label theMSDS statement set forth below. ' '0 , 

### , , "Have the productMaterial Safety Data Sheet (MSDS) with you when calling a doctor orgoingfor treatment:." , , ) ) ., » , 

### , " Please review this letter and advise me whether I can make the suggested changes to TX-I08tJ1's label. Th'llJty?') in advance for yourprompt attention to this matter. lf youhave any questions, please feel freeto**b)llm~t** me directly.

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Oaude H. Wolf, MSc., CorporateToxicologist CHW/cw " ,)'
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## " DATE'ON APPLICATION EPA RECEIVE DATE PM ''RECEIVE "DATE

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ENVIRON. FATE**r------r--~--_r----~------~** FISH/WILDLIFE OTHER
________**~**__ __**~-----L-------L------L-----~** ',. STATUS
________**~**________________________**~~**________**~** 

### AUG 30 2000 ,, "

RESPONSE CODS RESPONSE DATE

,**~**UNITED STATES- ENVIRONMENTAL PROTECTION AGENCY



### Mr. Claude H. Wolf Nalco Chemical Company One Nalco Center Naperville, 1160563 Dear Mr. Wolf: Subject: TX-l086l EPARegistration No. 1706-184 Your Amendment Dated May 25, 2000 

### AUG 30 2000

This is in response to your amendment to reconsider the precautionary statements as it appears in the Sodium Hypochlorite Standard
.. Your request to reconsider the precautionary statements as it appears in the Sodium Hypochlorite Standard would be acceptable, however, you must submit a proposed label with the following comments. The precautionary statements should read as follows: Precautionary Statements Hazards To human and Domestic Animals Danger: Corrosive may cause severe skin and eye irritation or chemical bumto broken skin. Causes eye damage. Wear safety glasses orgoggles and rubber gloves when handling. Avoid breathing vapors. Vacate poorly ventilated areas as soon as possible. Do not return until strong odors have dissipated. Revise the "The Statement ofPractical Treatment" per PRNotice 2000-3 dated April 11, 2000. First Aid Statement rfSwallowed: Call poison control center ordoctor immediately for treatment advice. Have person sip a glass ofwater ifable to 

### swallow. Do not induce vomiting unless told to do so by the poison control centerordoctor. Do not give anything bymouth to an unconscious person. Ifon skin orclothing: Take offcontaminated clothing. Rinse skin immediately with plenty afwaterfor 15-20 mjnutes Call a poison control center or doctor for treatment advice.
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### Ifinhaled: Move person to fresh air. 

### Ifpersonis not breathing, call 911 or an ambulance then give artificial respiration, preferably mouth-ta-mouth ifpossible. Call a poison control center or doctor for further treatment advice. 

### Ifin eyes: Hold eye open and rinse slowly and gently 

### with water for 

### 15-20 minutes. Remove contact lenses, 

### ifpresent, afterthe first 5 minutes, then 

### continue rinsing eye. Call 

### a poison control center Or 

### doctor for treatment advice. Please note that the general statement, "Havetheproduct container or label with you when 

### calling a poisoncontrol center ordoctor orgoing for treatment" should be included atthe beginning orend ofthe first aid statements. Also, an emergency telephone number may be included at the end ofthe statement. Ifyou have any questions, please call Marianne Clark at (703) 308-6381.

Robert S. Brennis Product Manager (32) Regulatory Management BranchII Antimicrobial Division (751**~C)**DP BARCODE, D266597 

# m{JA
CASE, 064909 SUBMISSION, S580637 DATA PACKAGE RECORD BEAN SHEET DATE, 

### 06/08/00 Page 1 of 1 

## * * * CASE/SUBMISSION INFORMATION 

## * * * CASE TYPE, REGISTRATION ACTION, 307 FQPA TECH-LBL REV AMD DAT CHEMICALS: 013907 Sodium bromide 014703 Sodium hypochlorite ID#, 001706-00184 TX-l0861 COMPANY, 001706 NALCO CHEMICAL CO. PRODUCT MANAGER, 32 ROBERT BRENNIS PM TEAM REVIEWER, MARIANNE CLARK RECEIVED DATE, 

### 06/01/00 DUE OUT DATE, 

## * * * DATA PACKAGE INFORMATION 

## * * * DP BARCODE, 266597 EXPEDITE, N CHEMICAL: 013907 DP TYPE: 001CSF, Sodium bromide LABEL, Y DATE SENT, 

### 06/08/00 ROOM, CSl ROOM, CSl

DATE RET. , 13.6600% 9.4100%

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### 1 1

ASSIGNED TO

DIV , AD BRAN, PSB SECT, 

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### 1 1 1 1 1 OUT 

### 1 1 ADMIN DUE DATE, 

### 09/26/00 NEGOT DATE, /**~/,.Jt/""**

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## * * * DATA REVIEW INSTRUCTIONS 

### * * ***r"f'~\(?** ,---.- "**~G~ute,'"-Tox:** ! 

### Please review the attached label and cover Itr in which the registrant is asking EPA to reconsider the requirement for adding the text cited in registration letter dated 4/27/2000 (copy attached) No specific data was submitted with submission 

## * * * DATA PACKAGE EVALUATION 

## * * * No evaluation is written for this data package



## * * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION 

### * * * BRANCH/sECTION DATE OUT DUE BACK INS CSF

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. LABEL

### DP BARCODE, D266597 CASE, 064909 SUBMISSION, S580637 DATA PACKAGE RECORD BEAN SHEET DATE, 06/08/00 Page 1 of 1 

### * 

## * * CASE/SUBMISSION INFORMATION 

### * * * CASE TYPE, CHEMICALS, REGISTRATION 013907 Sodium 014703 Sodium 

### ACTION, bromide hypochlorite 

### 307 FQPA TECH-LBL REV AMD DAT
ID#, 001706-00184 TX-10861 COMPANY, 001706 NALCO CHEMICAL CO. PRODUCT MANAGER, 32 ROBERT BRENNIS PM TEAM REVIEWER, MARIANNE CLARK RECEIVED DATE, 06/01/00 DUE OUT DATE, 703-308-6264 703-308-6381 11/28/00 

## * * * DATA PACKAGE INFORMATION 

### * * * DP BARCODE, 266597 EXPEDITE, N DATE SENT, 06/08/00 CHEMICAL: 013907 Sodium bromide DP TYPE: 

### 001CSF, Y LABEL, Y ROOM, CS1 ROOM, CS1

DATE RET. , 13.**6600~** 9.4100%



### / 6C

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ASSIGNED TO DATE IN DATE OUT ADMIN DUE DATE, 09/26/00

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### / / / / PROJ DATE, 

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## * * * DATA REVIEW INSTRUCTIONS 

### * * * Acute Tax: Please review the attached label and cover Itr in which the registrant is asking EPA to reconsider the requirement for adding the text cited in registration letter dated 4/27/2000 

### {copy attached) No specific data was submitted with submission 

## * * * DATA PACKAGE EVALUATION 

### * * * No evaluation is written for this data package



## * 

## * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION 

### * * * BRANCH/SECTION DATE OUT DUE BACK 

### INS CSF 

### / /

LABEL

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

August 23, 2000 MEMORANDUM OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Subject: Acute Toxicity Review for EPA Reg. No.: 1706-184/TX-1086l DP Barcode: D266597
To: Case No: 064909 Robert Brennis, PM 32 

### Regulatory Management Branch 

### Antimicrobials Division (751 **DC)** 

### From: Ian Blackwell, Biologist

# ~'iIJ!fl{4~ Efficacy Evaluation Team Product Science Branch Antimicrobials Division (7510C) Through:

Applicant: 

### Karen Hicks, Team Leader Chemistry and Toxicology Team Product Science Branch Antimicrobials Division (7510C) Michele E. Wingfield, Chief 

### Product Science Branch Antimicrobials Division (751 **DC)** 

### Nalco Chemical Co. FORMULATION FROMLABEL: 

### Active IngredientCs): Sodium hypochlorite 

### Sodium bromide Other Ingredient(s): Total: % bywt. 

### 9.41 13.65 76.94 100.00%BACKGROUND:NalcoChemical Co. has submittedarebuttaltoa 2/9/2000PSB/AD acute 

### toxicity review. In their letter, Nalco states that they cannot agree with

### the Precautionary StatementsprescribedbyAD, Theletter goes onto state that theypreferto use labeling for a 12.5% Sodiumhypochloriteproductthat wouldbe derived from the February, 1986,EPA document: 

### Guidance for the Reregistration of Pesticide Products Containing Sodium and Calcium Hypochlorite Salts as The Active Ingredient.
RECOMMENDATIONS: PSB fmdings are: Although the 1986 document mentioned above was superseded several years ago by the February 1992 EPA RED for Sodium and Calcium Hypochlorite Salts, the 1986 document is still referenced for several matters.
The acute toxicity profile for Reg. No. 1706-184 is currently: 

### acute oral toxicity I waived acute dermal toxicity I 

### waived acute inhalation toxicity I waived primary eye irritation I waived primary skin irritation I waived dermal sensitization I waived
LABELING: PM 32 has informed PSB that the February, 1986, EPA document: 

### "Guidancefor the Reregistrationof PesticideProducts ContainingSodium andCalciumHypochloriteSalts as The Active Ingredient' is still being followed for products containing sodium hypochlorite as an active ingredient. Thus, accordingto the 1986 standard, theprecautionary statements for this product should state: Precautionary Statements: DANGER: Corrosive, may cause severe skin and eye irritation or chemical burnto broken skin. Causes eye damage. Wear safety glasses or goggles and rubber gloves whenhandling this product. Wash after handling. Avoidbreathing vapors. Vacate poorly ventilated areas as soon as possible. Donot return until strong odors have dissipated.
Statements ofPracticalTreatment:

### IfContact with Eyes Occurs: Flush with water for at least 15 minutes. Getprompt medical attention. *If

### Contact with Skin Occurs: Wash with plenty soap and water. IfSwallowed: Drink large quantities ofmilk or gelatin solution, ifthese are not available, drink large quantities ofwater. DO NOT give vinegar or other acids. DO NOT induce vomiting. Get prompt medical attention. *Theregistrantmaychooseto add "Contactmedicalpersonnel ifsymptomspersist",butthis language is optional.

### August 23, 2000
NOTE TO THE PM: 'This product does not have a sodium hypochlorite percentage of 12.5% as per the 1986 Registration Guidance package. However, AD is still allowingthe use ofthe labeling from that standard forthis product. Should the PMTeam choose to use standard labeling for this product,pleaserefertotheLabel ReviewSystemfor labeling specifictoReg.No. 1706-184.

### "

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# 3(il/dt2NALeo CHEMICAL COMPANY ONE NALCO CENTER NAPERVILLE 11, UNOIS 60563 1198 Cl AREA 630 305-1000

Mr. Robert Brennis U.S. Environmental Protection Agency Antimicrobial Division (7510W) 410 M. Street S.W. Washington, D.C. 20460 May 25, 2000

Subject: Registration ofNalco TX-10861**(1706~184) D~ar**  Mr. Brennis: Nalco Chemical Company cannot agree vvith the precautionary statement revisions cited in your letter of registration for this product. The product contains 9.4% Sodium hypochlorite and approximately 14% Sodiumbromide. Nalco believes the precautionary statements currently on the label already exceed those required for a 12.5% Sodium hypochlorite product. The Sodium bromide component adds nothing to the product's potential hazards. We believe the product is properly labeled for a materialwith high pH (-14). The required language for a 12.5% Sodium hypochlorite formulation reads "DANGER: Corrosive. May cause severe skin and eye irritation or chemical burns to broken skin. Wear safety glasses or goggles and rubber gloves when handling. Avoid breathing vapors. Vacate poorly ventilated areas as soon as possible. Do not return until strong odors have dissipated." (Guidancefor the Reregistration ofPesticide Products Containing Sodium and Calcium Hypochlorite Salts as The ActiVe Ingredient; NTIS Document: PB87- 103222; Feb 1986). The labeling for a corrosive product under ANSI Standard 2129.1-2000 is consistent with theprecautionary statements currently appearing on our draftlabel. Nalco would consider adding to the precautionary statement the additional text, "
...Avoid breathing vapors. Vacate poorly ventilated areas as soon as possible. Do not return until strong odors have dissipated." As such appears in the Hypochlorite Generic Standard cited above. We requestyou reconsider the requirementfor adding the text cited in the registration letter. Ifyou have any questions, please feel free to contact me directly.

laude H. Wolf, MSc., Corporate Toxicologist CHW/cw "

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# , US ENVIRONMENTAL PROTECTION AGENCY OF-F-ICE OF PESnClOES PROGRAMS

REGISTRATION DlVISION (T5·757/ WASHINGTON. DC 20460**~OTlCE** OF PESTICIDE·**~III:E<OISnUTloN** • DIII:EIII:EGISTIII:,o,T.oN (Under the Feder
.. ' fnliee/icide, Fune1cide, and**Rodentie~e** Acl,**.~** I1l7jcnded) NAME ANO AODRESS OF REGISTRANT (lnel",d_ ZIP cod_) 

### r Nalco Chemical Company OneNalco Center Naperville, 

## n60563 L €p., RtGISTR,o,TION NO. 

### f-J,706-l'il4

YERM OF ISSUANCE 1 0,o,T€**O~** ISSU,o,NCt WP 

### 27 00"0 r,1 1\ L::UU'

N,o,ME OF PESTICIDE PROOUCT 

### TX-l0861**NOT~;** Chances in t.belinc: (onnull differine: in subsllnee (rom th
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. . .ubautted to.nd .ecepted by the Rel:istration DiVision prior to use

### ot~::ted Itl .conneetion
...ith this reristrltion must be produc:tat
....J'$ refer to tbe
..bove U.S. EPA rel:istration number. label In eommeree. In any eorrespondenee on this Oa tbe basis of Wormation (urnished by the rel:istrlnt the Ib d·
. . the Federal lnsedieide, Funcicide, .nd Rodentieidc Act. ove name pestlclde is hereby Reeistered/Rerell"istered uDder Ta Ion erell$trlt1on ts returned here
...ith A cop), 01 tbe libeline .cccpted in conneetion with this Reeist t· /R
. . . Recistratioo. is in no ....)' to be construed.s.n irn:iorsement or. ov I ci h· •

### ~~lth.•Dd the enviroomeo.t, the AdminIstr.toc, on his motion maPPC • . t IS product by this ACeney. In order to proteet

### Jeid~ 1D. .ecord,nee wlIh the Aet. The .ceeptuet of any

### n.~**inYe~:y ~une** **~uspend oc.e.nc~1**  the recistraUon of. pest. Act IS not to be eonstrued IS eivina: the rea:isttlnt a rq-ht t x I . ehon
...Ith the reeatt.t1OD. of. product lUlder Ihis by others_ 0 e e USlVe use o( Ihe name or to its; use if it has; be 

### This productis conditionally registered in accordance with FIFRA section en Govcred 

### 3(c)(7)(A) providedthat you: 1. Submit/cite all datarequired for registration/reregistration ofyour product under FIFRA section 3(c)(5) or 4(a) when the Agency requires all registrants ofsimiliar products to submit such data. 2. Makethe labeling changes listed belowbefore youreleasethe product for shipment:
. 

### a. Add

### the phrase "EPARegistrationNo. 1706-1l14"
•

### h. Restricted Use Classification Recommended. Dueto acute oral, acute dermal, acute inhalation, eye irritation, dermal irritation toxicity categories. See below. SIGNAL WORD: DANGER POISON SKULL and CROSSBONES symbol

c. Precautionary Statements should berevised to read: Fatal ifswallowed or asorbed through skin or inhaled. Corrosive. Causes irreversible eye damage or skin burns. Do not get ineyes, on skin oronclothing. Do not breathe spray mist. Wear goggles or face shield. Forhandling activities, use a NIOSH Respirator with an organic vapor (OV) cartridge or canister with anyN<P< R, or HE prefilter. Wearprotective clothing and rubber gloves. Wash hands before eating, drinking, chewing gum, using tobacco or usingthe toilet. Remove contaminated clothing and wash clothing beforereuse. 

# o ATTACHMENT IS APPL.ICA8LE

### 'IQNA~**~** \ OATE2 d. Revise Statement ofPratical Treatment to read: 

### IfSwallowed: Call a poison control center or doctor immediately for treatment advice. Haveperson sip a glass afwaterifableto swallow. Do not induce vomiting unless told to by a poison control center or doctor.
e. 

### IfOn Skin: Take offcontaminated clothing. Rinse skin immediately with plenty of water for 15-20 minutes. Call a poison control center ordoctor for treatment advice. 

### f. IfInhaled: Move personto fresh air. Ifpersonis not breathing, call 911 or ambulance, then give 

### artificial respiration, preferably mouth-to-mouth, ifpossible. Call a poison control center or doctor for further treatment advice. 3. Submit one copy ofyour final printed labeling before yourelease the product 

### for shipment. Refer to the A-79 enclosure for a further description offinal printed labeling. Ifthese conditions are notcomplied with, the registration will be subjectto cancellation in accordance with FIFRA section 6(e). Your release for shipment ofthe product constitutes acceptance ofthese conditions. A stamped copy ofthe label is enclosed for your records.

# ~ Robert S. Brennis**Product~anager(32)** 

### Regulatory Management Branch II Antimicrobial Division (751 DC)----,----



### TX-I0861 Microorganism Control Chemical TX-10861 is an effective agent for controlling algal bacterial and fungal slime in condensing and cooling cquipment in which recirculating water is used as the cooling media and in reservoirs or ponds that serve as the source ofboiler feedwater or cooling water. TX-I0861 can also be used to control bacterial, fungal and algal slime in decorative fountains, air washers. and papennill influcnt and proccss water systems. ACTIVE INGREDlENTS: Sodium hypochlorite
........................"
...............................................9.41'% Sodium bromide
.............................................................................. 13.650/0 INERT INGREDIENTS 76.94% Total
.............................................................................................. 100.00% Total Available bromine = approximately 21.2%(expressed as chlorine = approximately 9.4%) KEEP OUT OF REACH OF CHILDREN 

## DANGER
STATEMENT OF PRACTICALTREATMENT IFIN EYES: Immediately flush with plenty ofwater for at least 15 minutes. Call a physician. IF ON SKIN: Immediately wash with soap and plenty of water. Remove contaminated clothil1g and wash before reuse. Get medical attention ifirritation persists. IF SWALLOWED: Drink large quantities of water. Do not induce vomiting. Call a phySician or poison control center immediately. NOTE TO PHYSICIAN: Probable mucosal damage may contraindicate the use ofgastric lavage. Measures against circulatory shock, respiratory depression and convulsions may be needed.
SEE SIDE PANEL FOR ADDITIONAL PRECAUTIONARY STATEMENTS
PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS 

### DANGER. CORROSIVE. CAUSES SEVERE EYE AND SKIN INJURY. HARMFUL IF INHALED. HARMFUL IF SWALLOWED. Do not get in eyes, on skin or on clothing. Wear goggles or face shield and rubber gloves when handling. Remove and wash contaminated clothing before reuse. Wash thoroughly after handling. ENVIRONMENTALHAZARDS This pesticide is toxic to fish and aquatic organisms. Do not diSCharge effluent containing thisproduct into lakes, streams, ponds, estuaries, oceans, or public waters un\css in accordance with the requirements of a National Pollution Discharge Elimination System (NPOES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containingthis productto sewer systems without previously notifying the sewage treatment plant authority. For guidance contact your State Water Board orRegional Office ofEPA. Apply this pesticide only as specified on the label. STORAGE AND DlSPOSAL STORAGE: Do not contaminate water, food, or feed by storage, disposal or cleaning ofequipment. PESTICIDE DISPOSAL: Pesticide wastes are acutely hazardous. Improper disposal of excess pesticide, spray**mix~ure** or rinsate is a violation ofFederal law. Ifthese wastes cannot be disposed ofby use according to label inslructions, c::mtact your State Pesticide or Environmental Control Agency, or the Hazardous Waste representative at the nearestiEPA Regiona? OffiCe-for guidance. ACGEPT,8D withCO}lY..:JNTG inEPALetter Duted:CONTAINER DISPOSAL METAL CONTAINERS: Triple rinse (or equivalent). Then offer for recycling or rcconditioning, puncture and dispose of in a sani.tary landfill, orby other procedures approved by State and Local authoritics. PLASTIC CONTAINERS; Do not rcuse empty container. Triple rinse (Or equivalent). Then puncture and disposc of in a sanitary landfill, or, ifallowed by State and Local authorities, by burning. Ifbumed, stay out ofsmoke. 

### DIRECTIONSFORUSE It is a violation ofFederal law to use this product in a manner inconsistent with its labeling. COOLING PONDS, RESERVOIRS AND DECORATIVE FOUNTAINS TX·I0861 may be applied at the rescrvoir, pond orfountain inlet or at a location that permits complete diffusion into the water at maximum retention timc before reaching the outlet. SufficientTX-10861 should be fed to maintain a total bromine level of4.5
. 9.0 ppm in all parts ofthe reservoir or pond (two OWlceS per 1000 gallons ofwater (wt.lvol.) yield 3.2 ppm total bromine). INDUSTRIAL & COMMERCIALRECIRCULATING COOLINGWATER SYSTEMS TX-\0861 should be applied directly to the cooling water at any section ofthe system where sufficient mixing will Occur. TX· 10861 should be applied to the cooling water to provide a total bromine level of4.5

- 9.0 ppm. TX-\0861 at a dosage oftwo ounces per 1000 gallons of water (wtJvol.) gives a dosage of approximately 3.2 ppm of total bromine, but severnl times that dosage may be rcquired to provide a total brominc level of 3.2 ppm throughout the system. The total bromine level should be checked with a test kit and additional product applied until a reading of 4.5

- 9.0 ppm is obtained at the bleed-offpoint. Some systems may be maintained in satisfactory biological condition by applying this dosage once pcr day while othcrs will respond better to dosages lcss than once per day. AIRWASHERS (Thisproductmay be used only in indWitrial air washers and air washersystems, which have mist-eliminating components.) For control ofmicroorganisms in industrial air washer systems add sufficient TX·10861 to the air washer sump or chill water to provide a total bromine level of4.5 • 9.0 ppm. Badly fouled systems must be cleancd before trcatment is begWl. TX·10861 at a dosage oftwo ounces per 1000 gallons ofwater (wt.lvol.) gives a dosage ofapproximately 3.2 ppm oftotal bromine, but several times that dosagc may be required to provide a total bromine level of3.2 ppm throughout thc system. The total bromine level should be checked with a test kit and additional product applied until a reading of4.5
. 9.0 ppm is obtained at the bleed·nff point. Some systems may be maintained in satisfactory biological condition by applying this dosage once per day while others will rcspond better to dosages less than oncc perday. HEATTRANSFER SYSTEMS (Such as Evaporative Condensers, Hydrostatic Sterilizers and Retorts, Dairy Swcetwater Systems, and Oncc-Through Cooling Water Systems) TX·10861 should be used at the same appl,ication rates, and in the samc manner as described above. 1t should be added to the system at a point ofWliform mixing such as a basin area, ,sump area, or other reservoir or collecting area from which the treatcd water will be circulated uniformly throughout the system. FORPULP & PAPERMILL INFLUENT WATER SYSTEMS TX-10861 should be apptied to the raw water intake prior to the filter house, economizer, or proccss water. Fced at a dosage sufficient to provide a total bromine level of 4.5

- 9.0 ppm. TX-I0861 at a dosage oftwo ounccs per 1000 gallons Of watcr (wt./vo\.) gives a dosage of approximately 3.2 ppm oftotal brominc, but several times that dosage may bc required to**p({l~ide** a tota.! bromine level of3.2 ppm throughout the system. The total bromine level should be checked with a test kit and additional product applied until a reading' of 4.5

- 9.0 ppm is obtained. Some systems may be maintained in satisfactory biological condition by applying this dosage. intermittently while others may require a eontinuous application. TX·10861 may be used in pulp and paper influent water systems where the manufacturcd paper or paperboard may be used for food contact purposes. FORPULP & PAPERMILL PROCESSWATER SYSTEMS TX·10861 should be added to a paper making system at a point ofuniform mixing such as thc beaters, broke chest pump, save· all tank, or white watcr taak. Feed at a dosage sufficient to provide a t"fnbbromine Icvel of4.5

- 9.0 ppm. TX-I086t at a 1'>.'1:'

....**£~--'...J** wit;,**CO:.::.::::~T:::;** in EPA L()ttcr**D::.~sd:**

### ~~?r;:**~1:,2~ '~·~7='~~~_~.:~}~~;t~~**  --.' " .'-**'''.,~''''~** 

# - "",---

dosage oftwo ounces per 

### tOoo gallons ofwater (wt./vol.) gives a dosage ofapproximately 3.2 ppm oftotal bromine, but several times that dosage may be required to provide a total bromine level of3.2 ppm throughout the system. The total bromine level should be checked with a test kit and additional product applied until a reading of4.5

- 9.0 ppm is obtained. Some systems may be maintained in satisfactory biological condition by applying this dosage intermittently while others may require a continuous application. TX-t0861 may be used in pulp and paper mill process water systems where the manufactured paper or paperboard may be used for food contact purposes. NOTE: Halogen dosages listed in the various applieations are expressed as bromine. Since most field test kits for oxidizing halogens give values in terms ofchlorine, simply multiply the reading from the test kit (as chlorine) by 2,25 in order to obtain the bromine equivalency listed in these directions.
EPA REG NO. 1706- EPA Est. No. 1706-IL-Ol NET CONTENTS SHOWN ELSEWHERE ON CONTAINER

in I:?ALetter D::.:;od:NALCO CHEMICAL COMPANY ONE NALCO CENTER

Mr. RobertBrennis ProductManger (32) Antimicrobial Division (7510W) U.S. Environmental Protection Agency 410 M. StreetSW Washington, D.C. 20460 January 5, 2000



## ,Rft{ Subject: Resubmission ofApplication for Registration Na1co**TX~10861** (1706-Rl1t) DearMr. Brennis: Nalco Chemical Company submits this letter in response to your letter dated November3,1999 in which several deficiencies are described. The issue regardingan FDA opinion letter in supportofthe use ofthis productin the manufacture of food contactpaper or paperboard remains open. FDA does not issue such letters. The traditional approach to "approval" is via listing in the Code of Federal Regulations (CFR). Forexample, 21CFR176.300 defines the listofbiocide (antimicrobial) active ingredients which may "safely" be employed in the manufactureofsuch products destined for use in the manufactureof food contact articles. Paragraph 176.300(d) defines those inert substances that may be utilized to compound end-use formulations. A copy of the regulation is enclosed for your use. Additionally, I am resubmitting copies of the documentation establishing "approval" for the ingredients in TX-10861 as they apply to food contact paperor paperboard. We request that you re-examine the need for such a letter from FDA. Regardingthe acute toxicology waiver issue, we do not agree with the reviewer thatciting 1706-179 is unacceptable based on thefact thatacute toxicity tests were not submitted for that product. The acute "six pack" was waived for thatproduct based on its "similarity" to 1706-171, the sodium bromide componentnotwithstandingsince it has no significant impacton the toxicity of the product. The currently proposed label forTX-10861 bears the following precautionary statements: DANGER. CORROSIVE. CAUSES SEVERE EYE AND SKIN INJURY. HARMFUL IF INHALED. HARMFUL IF SWALLOWED. Do not getin eyes, on skin or on clothing. Wear goggles or face shield and rubber gloves when handling. Remove and wash contaminated clothing before reuse. Wash thoroughly afterhandling. Theprecautionarystatement required for 12.5% Sodiumhypochlorite products (from the Reregistration Decision documents) states: DANGER. CORROSIVE. MAY CAUSE SEVERE EYE AND SKIN IRRITATION OR CHEMICAL BURNS TO BROKEN SKIN. Causes eye damage. Wear face shield or goggles and rubber gloves when handling this product.
. Wash after handling. Avoid breathingvapors.Vacate poorly ventilated areas as soon as possible. Do not return until strongodors have dissipated. The currentlabel for 1706-171 (95ND141) bears the same precautionary statement as TX-10861.With regard to the "six-pack" tests for TX-10861, we offer the following comments: 1. The primary eye and skin irritation tests (81-4 and 81-5) arenotrequired due to torrosivity [158.340-(b) note21. 2. The dermal toxicity (81-2) is notrequired due to corrosivity 1158.340-(b) note 2}. 3. The acute inhalation toxicity test (81-3) is notrequired since the product does not consistof or duringnormal conditions ofusewillnot resultin an inhalable material [158.340-(b) note 16]. 4. The dermal sensitizationtestis not required since there is no expected repeated dermal contact duringuse. Additionally, the product's corrosivity precludes conduct of a meaningful sensitization test. Thus, the only testthatwould conceivably be required would be the acute oral toxicity test (81-1). It appears based onthe reregistration ofsodium and calcium hypochlorite products that 12.5% sodium hypochlorite products fall into Category III for acute oral toxicity. Duringreregistration ofits 1706-171 product, Nako submitted an acute oral study (no MRlD number was assigned). The studywas a single dose (5 g/kg)study. Six of the 10 rats administered thatdosage died during the test period. A copyof that report is included with this letter. Thus the LDsowould be clearly within Category Ill. This category requires a "maybeharmful ifswallowed" statement. Such a statementcurrently appears on the TX10861 label. The oral LDsofor 43% Sodium bromidesolution is 4200 mg/kg (Organic Halide RED) placing it in Category III. We seeno reason to suspectany synergistic effect between the bleach and the bromide that would change the lethality ofthe formulated productsosignificantly as to place it in a higher Category. Thus we conclude that there would be nothinggained by subjecting a group or groups ofrats to this productjustto reestablish that its o;allethality would fall into Category III. Consequently? weagain request thatthis test be waived. I amhopeful thatthis submission will adequately resolve the two outstandingissues of this application for registration and allow for a prompt, successful registration ofTX-10861. We await a copy of the "stamped accepted" label. If you have any questions, please feel free to contact me directly.

# (;}~:I- Corporate Toxicologist

## \

! 

# "- VOLUME II STUDY TITLE Acute Oral Toxicity-Albino Rats
DATA REQUIREMENT 40CFR158.340 Guideline: 81-1

TEST ARTICLE Sodium Hypochlorite - Case 

### # 0029 Product: Nalco Actiplus 2818
AUTHOR 

### sandra M. smith American Biogenics Corporation Decatur, II 62526
SUBMITTER 

### Nalco Chemical Company One Nalco Center Naperville, II 60563-1198

Volume II 

### Page 1 of 18

### Pages 26-42 *Access to FIFRA health and safety data is restricted under FIFRA section 10(g)*

### DP BARCODE, D262279 

# (&PA

CASE, 064909 SUBMISSION, S573600 DATA PACKAGE RECORD BEAN SHEET 

## * 

## * * CASE/SUBMISSION INFORMATION 

### * * 

### * DATE, 01/11/00 Page 1 of 1


### CASE TYPE, CHEMICALS, REGISTRATION 013907 Sodium 014703 Sodium 

### ACTION, bromide hypochlorite 

### 187 RESB AmD-OC-MINOR CHG


### ID#, 001706-RIU TX-10861 COMPANY, 001706 NALCO CHEMICAL CO. PRODUCT MANAGER: 32 ROBERT BRENNIS PM TEAM REVIEWER: MARIANNE CLARK 

### RECEIVED DATE, 01/07/00 DUE OUT DATE, 703-308-6264 703-308-6381 05/06/00 

## ) * * * DATA PACKAGE INFORMATION 

### * 

### * * DP BARCODE, 262279 EXPEDITE, N DATE SENT, 01/11/00 CHEMICAL: 013907 Sodium bromide DP TYPE: 001CSF: Y 

### ASSIGNED TO DATE IN

DIV, AD 

### //11/"'''' BRAN, PSB I / II / 0 " 

### SECT, 

# c;:g:, .J" 

### I. II / II / '" tJ 

### REVR 

### ,::IJ,v....."V,(j/."l6.VIC/-n/' CID CONTR, I

### ~~/dO DATE 

### / / / / / OUT 

### / / / / / ADMIN DUE 

### NEGOT

PROJ



### * * 

### * DATA REVIEW INSTRUCTIONS 

### * 

### * * 13.6600% 9.4100%


### ROOM, CS1 ROOM, CS1 6C 6W44



### DATE RET., /
DATE, 04/15/00 DATE, 

## 'it/., /0'" DATE, 

### S 

### !z.2./0 '" 

### /

Acute Tox: Please review the attached cover letter and data submitted in reponse to EPA Itr dated 11/3/99.



### * 

## * * DATA PACKAGE EVALUATION 

### * * * No evaluation is written for this data package



## * * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION 

### * * * DP Be 

### BRANCH/SECTION DATE OUT DUE BACK INS CSF LABEL

### DP BARCODE: D262279 CASE, 064909 SUBMISSION, S573600 DATA PACKAGE RECORD BEAN SHEET DATE, 01/11/00 Page 1 of 1 

### * 

## * * CASE/SUBMISSION INFORMATION 

### * * * CASE TYPE: REGISTRATION ACTION: 187 RESB AmD-OC-MINOR CHG CHEMICALS: 013907 Sodium bromide 014703 Sodium hypochlorite ID#, 001706-RIU TX-10861 COMPANY, 001706 NALCO CHEMICAL CO. PRODUCT MANAGER: 32 ROBERT BRENNIS PM TEAM REVIEWER: MARIANNE CLARK RECEIVED DATE, 01/07/00 DUE OUT DATE, 703-308-6264 703-308-6381 05/06/00 

## ) * * 

## * DATA PACKAGE INFORMATION 

### * * * DP BARCODE: 262279 EXPEDITE: N CHEMICAL: 013907 Sodium bromide DP TYPE: 001CSF, y 

### LABEL, Y DATE SENT, 01/11/00 ROOM, CS1 ROOM, CS1

DATE RET. : 13.6600% 9.4100%

6C 6W44



### / /

ASSIGNED TO

DIV , AD BRAN, PSB SECT, CTT REVR : DATE IN 

### DATE OUT ADMIN DUE DATE, 04/15/00

CONTR:



### )

DP BC 

### / / / / NEGOT DATE: 

### / / / / / PROJ DATE, 

### / / / / / / / / / / / / / 

## * * * DATA REVIEW INSTRUCTIONS 

## * * * Acute Tox: Please review the attached cover letter and data submitted in reponse to EPA ltr dated 11/3/99.



## * * * DATA PACKAGE EVALUATION 

### * 

## * * No evaluation is written for this data package



### * * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION 

### * * * BRANCH/SECTION DATE OUT DUE BACK


# COPT fOR YOOR

IIiFORMATIGIl INS CSF 

### / /

LABEL

## ) UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASIITNGTON, D.C. 20460

February 9, 2000 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### MEMORANDUM 

### Subject: Acute Toxicity Review for EPA Reg. No.: 1706-RIU 

### 1TX-10861 DP Barcode: D262279
To:



### From: Case No: 064909 Robert Brennis, PM 

### 321 Marianne Clark 

### Regulatory Management Branch Antimicrobials Division (751OC) Ian Blackwell, Biologist

# "f2.#iP/cGft{J~~~ Efficacy Evaluation Team ' Antimicrobials Division (751OC) 

# /l: 

# J'iO Through: 

### Product Science Branch 

# {A:' \"

Chemistry and Toxicology Team A 

# /VI.

.

# J 0\ 

# rfU Karen Hicks, Team Leader 

# t**~""J**/ ' 

# l C 

### Product Science Branch 

## !/v 

# J\' Antimicrobials Division (7510C); ,



### Applicant: Michele E. Wingfield, Chief 

### Product Science Branch Antimicrobials Division (751OC) 

### Nalco Chemical Co. FORMULATION FROM LABEL: 

### Active Ingredient(s): Sodium hypochlorite Sodium bromide 

### Other Ingredient(s): Total: % bywt. 

### 9.41 13.65 76.94 100.00%) 

### I. BACKGROUND: PSB has received a 

### 1/5/2000 letter from the registrant. The subject ofthis review is the portion of

### that letter that pertains to acute toxicology, orthe "six

### pack" aftests. The letter states the following: 1. Theprimaryeye and skinirritationtests are notrequired due tothe corrosivity ofthe product. 2. The acute dermal toxicity study is notrequired due to the corrosivity ofthe product. 3. The acute inhalationtoxicity studyis notrequired since theproduct does not consist of, or during nonnal use, result in an inhalable material. 4. Thedennal sensitizationtestisnotrequired duetothe corrosivityoftheproduct, and the corrosivity oftheproduct should preclude any conduct ofa useful sensitization study. The CSF lists the pH ofthis product as 14.
II. RECOMMENDATIONS: PSB findings are: 1. PSB waives the primary eye and skinirritation studies due to the pHofthis product and probable corrosivity ofthis product. Ithas been documented that concentrated bases are much more damaging totissues than are concentrated acids. 2. PSB waives the acute dermal toxicity study required for 1706-RIU due to the pH of the product. 3. The dermal sensitization study is waived. Thereasons are as follows: A. The product

### has a very high pH and is thought to be corrosive. B. Users oftheproduct arerequired to wearprotective clothing (chemical resistant gloves, etc.) because ofthe corrosivity ofthe product. C. Thisproduct is intendedtobeusedinenclosedrecirculatingwatersystems. This limits the chance for dermal exposure tothis product. 4. The acute inhalation toxicity study is waived. Thereasons are as follows: A. The high pH ofthe product could be severely damaging to the lungs, thereby potentially greatly reducing oxygen and CO2 transfer. B. Theproductisintendedtobeusedinenclosedwater systems. Thus,thepotential for inhalation is greatly reduced. 5. The registrant also indicates that they would like a waiver ofthe acute oral toxicity study because it would be inhmnane to dose animals 

### with a material that has a pH over 13. The waiver is granted. In cases like this the product is typically assigned toxicity category 

### 1.

### The acute toxicity profile for.File Symbol 1706-RIU is currently: acute oral toxicity I waived acute dennal toxicity I waived acute inhalation toxicity I waived primary eye irritation I waived primary skin irritation I waived dennal sensitization I waived
LABELING: 

### Date: 

### 02/09100 LABEL REVIEW SYSTEM 

### Page: I
ID #: 

### 001706-00184 TX-I0861 RESTRICTED USE CLASSIFICATION RECOMMENDED: Dueto acute oral, acute dennal, acute inhalation, eyeirritation, dennal irritationtoxicity categories. The PM Team should decide ifrestricteduse classification is necessary orifalternative labeling will allay the requirement for restricted use classification. SIGNAL WORD: DANGER POISON SKULL and CROSSBONES symbol PRECAUTIONARY STATEMENTS: Fatal ifswallowedor absorbedthrough skinorinhaled. Corrosive. Causesirreversible eye damage or skin burns. Do not get in eyes, on skin or on clothing. Do not breathe spraymist. Weargoggles orface shield. Forhandling activities, use aNIOSHrespirator withanorganicvapor (OV) cartridgeorcanisterwith any N, P, R, or HEprefilter. Wear protective clothing and rubber gloves. Wash hands before eating, drinking, chewing 

### gum, using tobacco or using the toilet. Remove contaminated clothing and wash clothing before reuse.
STATEMENT OF PRACTICAL TREATMENT (SOPT): IF SWALLOWED: Call a poison control center or doctor immediately for treatment advice. Have person sip a glass ofwater ifable to swallow. Do not induce vomiting unless told to by a poison control center or doctor.

### IF ON SKIN: Take offcontaminated clothing. Rinse skin immediately with plenty of water for 15-20 minutes. Call a poison control center or doctor for treatment advice. 

### IF INHALED: Move person to fresh air. If person is not breathing, call 911 or ambulance, thengive artificial respiration,preferablymouth-to-mouth, ifpossible. Call a poison control center or doctor for further treatment advice. 

### IF IN EYES: Hold eye open and rinse slowly and gently with water for 15-20 minutes. Remove contact lenses, ifpresent, after the first 5 minutes, then continue rinsing. Call poison control center or doctor for treatment advice.


### NOTE TO PHYSICIAN: Note to PMlCRMlRegistrant: The proposed label should containa "Note to Physician." The following statements are suggested types ofinfonnation that may be included, if applicable:
• technical infonnation on symptomatology; • use ofsupportive treatments to maintain life functions; • medicine that will counteract the specific physiological effects ofthe pesticide; • company telephone number to specific medical personnel who can provide specialized medical advice. The following "Note to Physician" statement is required for the subject product: NOTETO PHYSICIAN: Probablemucosaldamagemaycontraindicatetheuse of gastric lavage.SUBMISSION BAR CODE 

# #!3s t?8S/6 REVIEWER 

# H C

# /;eel:;

, 

### COPING FORM FOR APPLICATIONS FOR REGISTRATION/AMENDMENTS

'( ] 'CHILD RESISTANT PACKAGING: ( ] CERTIFICA'.\'ION ( ] NON-RESIDENTIAL USE ONLY ( ] NOT APPLICABLE REGISTRATION TYPE: ,( ] CONDITIONAL ( UNCONDITIONAL PROPOSED CLASSIFICATION: ( ] GENERAL RESTRICTED USE
DATE 'ON APPLICATION EPA RECEIVE DATE PM "RECEIVE 'DATE

METHOD 

### OF SllPPORT , ] CITE-ALL ] SELECTIVE , ,] NOT SUBMITTED ] NOT APPLICABLE 

# r INCORRECT/RESUB '!REVIEW (S) REQUESTED DATA
CHEMISTRY EFFICACY TOXICOLOGY

, HED TOX.

ENVIRON, FATE

, FISH/WILDLIFE OTHER
______ _ '" 'PACK 

### # 

## j)Jj-'7.5}"1



# DJ. 5155'7 FORMULAtoRS EXEMPTION ( .]. SUBMITTED ( ] NOT SUBMITTED

, ( ] NOT APPLICABLE

( 'L.INCORRECT/RESUB
DATE SENT 

## '1

# b.oh9

, I 

# qb619 Ci

I I

. DUE DATE 

# 1//3/60 

# 1If:!In () I DATE RETURNED



### .


# 11.27/9'7 I

STATUS
___**~**_____________**~_~**____**~**

RESPONSE CODE 

# _.J..!=J
.....__ RESPONSE DATE

## )

SYMBOL. SURNAME OATE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY



### Mr. Claude H. Wolf Nalco Chemical Company One Nalco Center Naperville, II 60563 Dear Mr. Wolf: Subject: TX-l0861

### ~.. \v 

## >1"'1'\ EPA Registl'flti<>n No. l706-RlU Your Resubmission Dated September 9,1999 

## NOV 3 1999

This is inresponse to your resubmission ofwaiver request for acute toxicity data requirements (Guidelines 81-1 throught 81-6) based on identical formulation of"Nalco 95ND141 ", EPA Reg. No. 1706-179 with updated Confidential Statement ofFormula and label. Waiver request for acute toxicity data is not acceptable for the following reaSOns: The formulation ofTX-10861 is more concentrated (in terms ofthe active ingredient) than 95NDl41. Therefore, EPA Reg. Number 1706-179 and File Symbol 1706-RIU are not substantially (Toxicologically) similar based on the "double strength" version ofthe other and that acute toxicity data was not submitted for EPA Reg. No. 1706-179. Thus citing registration number EPA Reg. No. 1706-179to support file symbol l706-RlU is unacceptable. You must find some other method ofsupportjng the acute toxicity data requirements for File Symbol 1706-RIU and the precautionary labeling can not be recommended at this time. The revised Confidential Statement ofFormula dated September 9, 1999 is acceptable and it agrees with the label. Please note that the certified limits ofthe active ingredient shouldbe calculated on the nominal concentration and not the percentby weight. Resubmit a revised Confidential Statement ofFonnulawith the correct certified limits for the active ingredient. Also, a name and address is required for all suppliers. There is not a MRID Number assigned for the submitted product chemistry but it satifies Guideline series 61. COHCURREHCES 

# -

••••.••.•**J~**.••••••••.•••••••••••••••.•• _ ................................... 40
.........04 ••••••••**~** •••••••••••••••,. ......................................... .

, r . •• •.........................................**~**••••.•.•**~**....................... _ •••••••••••••••••• 

# .................. ...................r............. .. OFFICIAL FILE COPY

### 2 Request from FDA an opinion letter for the use of«food 

### grade paper or paperboard products" or label should have a disclaimer statement "not for use in manufacture offood grade paper." 

### Your application can be not be processed until the above materials are cOlTcted. Ifyou have any questions, please call Marianne Clark at (703) 308-6381. 

### Sincerely yours,

# ~$~ Robert S. Brennis Product Manager (32) 

### Regulatory Management Branch II Antimicrobial Division (7510C):i UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

September 27, 1999 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

MEMORANDUM Subject: Acute Toxicity Review for EPAReg. No.: 1706-RlU/ TX-10861 DP Barcode: D259557 Case No: 064909 To:



### From: Robert Brennis, PM 32 / Marianne Clark 

### Regulatory Management Branch Antimicrobials Division (751

### OC)

## ~ Ian BlaclcweU, Biologist

# ~;Cc

# ril&t

Through:

Applicant: 

### Efficacy Evaluation Team Product Science Branch 

### AntiInicrobials Division (7S10C) Karen Hicks, Team Leader Chemistry and Toxicology Team Product Science Branch Antimicrobials Division (751

### OC) Michele E. Wingfield, Chief 

### Product Science Branch Antimicrobials Division (751

### OC) 

### Nalco Chemical Company
FORMULATION FROMLABEL: 

### Active Ingredient(s): Sodium hypochlorite Sodium bromide Other Ingredient(s): 

### Total: % bywt. 9.41 13.65 76.94 100.00%

### BACKGROUND: Nalco Chemical Company requests a waiver from acute toxicity data requirements (Guidelines 81-1 through 81-6)fortheirproduct "TX-10861 ". Thebasis of this waiver request is that "the formulation is essentially identical to the registered product Nalco 95ND141 (Reg. No. 1706-179). 

### In their 9!9!991etter, the registrants go on to state, "This product, TX-10681 is essentially a 'double strength' 95ND141." Actually, what Nalco Chemical Company is trying to accomplish is not a waiver ofacute toxicity studies. Nalco is apparentlytrying to do, is to have theirproduct TX-10861 declared Substantially Similar or Toxicologically Similar to their otherproduct, 95ND141. There are a few issues to take into consideration in this similarity request: 

### 1. The formulation ofTX-10861 is more concentrated (in tenns ofactive ingredients) than 95ND141 is. As such, PSB does not feel that the two products can be found to be substantially similar. 2. "Bridging" ofacute toxicity data will not be allowed. Due to the acute toxicity profile of 95ND 141, bridging will not be allowed from each ofthe six acute toxicity/irritation studies. 3. When reviewing the registrationjacket ofReg. No. 1706-179 and PDMS. It

### is apparent that no acute toxicity data was submitted specifically for Reg. No. 1706-179.
RECOMMENDATIONS: PSB findings are: 1. The registrant has not even come close to submitting data sufficient tQ support a data waiver. Similarity ofFile Symbol 1706-RIUto Reg. No. 1706-179 is positively not an acceptable reason for a data waiver. 2. Reg. No. 1706-179 and File Symbol 1706-RIU are not Substantially (Toxicologically) Similar. The registrant even states that one product is a "double strength" version ofthe other. The registrants contradict themselves by saying that 1706-RIU is essentially identical to 1706-179, and, saying that 1709-179 is double strength 1706-RIU on the same page. 3. There are too many dissimilarities in the formulations of the two products and complications with the apparent toxicity categories of 1706-179 forPSB to allow 1706- 179 to bebridged to support 1706-RIU. 4. What is most important, is that there have been no acute toxicity studies submitted to support 1706-179. Thus, there are no acute toxicity studies for 1706-RIUto cite. The registrant must find some other method of supporting the acute toxicity datarequirements forFile SymboI1706-RlU. Citing Reg. No. 1706-179to support 1706-RlUis unacceptable.
The acute toxicity profile for reg. no. 1706-NIU is currently: acute oraltoxicity acute dermal toxicity acute inhalation toxicity primary eye irritation primary skin irritation dennal sensitization
LABELING: Not received Not received Not received Not received Not received Not received

No precautionary labeling can be recommended at this time.

### DP BARCODE: D259559 CASE: 064909 SUBMISSION, S568516 DATA PACKAGE RECORD BEAN SHEET DATE, 09/20/99 Page 1 of 1 * * * 

### CASE/SUBMISSION INFORMATION * * * 

### CASE TYPE: CHEMICALS, REGISTRATION 013907 Sodium 014703 Sodium ACTION: bromide hypochlorite 187 RESB AmD-OC-MINOR CHG / ''>13.6600% 9.4100% ID#, 001706·RIU TX·I0861 COMPANY: 001706 NALCO CHEMICAL CO. PRODUCT MANAGER, 32 ROBERT BRENNIS PM TEAM REVIEWER: MARIANNE CLARK RECEIVED DATE, 09/15/99 DUE OUT DATE, 703·308·6264 703-308-6381 01/13/00 * * * 

### DATA PACKAGE INFORMATION * * * 

### 'PP BARCODE: 259559 EXPEDITE: N CHEMICAL: 013907 Sodium bromide DP TYPE: 001 DATE SENT, 09/20/99 CSF, 

### Y LABEL, Y ASSIGNED TO DATE IN

DIV , AD 

### 7/..>47'7 BRAN, PSB 

### '7/02 

### 0/ '7 

### '1 SECT, qT 

### '7/,;u/ '7 '7 

### REVR , jl(n('{f, 

## '7 POI/e; 

# 1 CONTR,

## ~/

# 1t...&.f1-<i, / DATE 

### / / / / / OUT 

### / / / / / ADMIN DUE NEGOT

PROJ



### 10- 

## 1'1- Cf

# q * * * DATA REVIEW INSTRUCTIONS 

## * * * ROOM: CSl ROOM: CSl

DATE RET., /
DATE, 12/24/99 DATE, / / DATE, / /

Product chemistry: Please review the attached, updated CSF, label and data resubmitted to support registration of subject!s product.

DP BC 259557 * * * 

### DATA PACKAGE EVALUATION * * * 

### No evaluation is written for this data package

* * * 

### ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION * * * 

### BRANCH/SECTION PSB/CTT DATE OUT 09/20/99 DUE BACK 12/24/99 INS Y 

### CSF Y 

### 6C 6W44



### /

LABEL Y

### DP BARCODE: D259559 CASE, 064909 SUBMISSION: S568516 DATA PACKAGE RECORD BEAN SHEET DATE, 09/20/99 Page 1 of 1 

### * * * CASE/SUBMISSION INFORMATION 

### * * * CASE TYPE: REGISTRATION CHEMICALS: 013907 Sodium 014703 Sodium ACTION: bromide hypochlorite 187 RESB AmD-OC-MINOR CHG
ID#, 001706-RIU TX-10861 COMPANY, 001706 NALCO CHEMICAL CO. PRODUCT MANAGER: 32 ROBERT BRENNIS PM TEAM REVIEWER: MARIANNE CLARK RECEIVED DATE, 09/15/99 DUE OUT DATE, 703-308-6264 703-308-6381 01/13/00 

### * * * DATA PACKAGE INFORMATION 

### * * * PP BARCODE, 259559 EXPEDITE, N 'CHEMICAL: 013907 Sodium bromide DP TYPE, 001CSF, Y LABEL: DATE SENT, 09/20/99
Y ROOM: CS1 ROOM: CSI

DATE RET. : 13.6600% 9.4100%

6C 6W44



### / /

ASSIGNED TO

DIV , AD BRAN: PSB SECT: CTT REVR : DATE IN 

### DATE OUT ADMIN DUE DATE, 12/24/99

CONTR,

DP BC 259557 

### / / / 

### / NEGOT DATE, 

### / / / / / PROJ DATE: 

### / / / / / / / / / / / / / * * * DATA REVIEW INSTRUCTIONS 

## * * * Product chemistry: Please review the attached, updated CSF, label and data resubmitted to support registration of subject's product. 

## * * * DATA PACKAGE EVALUATION 

### * * * No evaluation is written for this data package



### * * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION 

### * * 

## * BRANCH/SECTION PSB/CTT 

# em_.

IlimMATIIB DATE OUT 09/20/99 DUE BACK 12/24/99 INS Y



## coPY**ro~** 

# V""R

Uti 10;1<",., 

### CSF Y 

### / 

### /

LABEL Y

### SUBJECT: PRODUCT CHEMlSTRY REVIEW

- Antimicrobials Division



### .. DP
.. llarcod'.12:15'1S.2'l··Reg
..No. orfile Symbol**t70{,~** 

### RILl 'Manufacturing-Use [ 

# J or End-Use Product [**~**

### Case#
__ 

### TO: 

## {!.4t;,**&~**MWkM<A<L 

# a,/I.L PM Team No.--",**~"'-_** FROM:



### THRU: Anna Skapars, Chemist

### ~ 

## Sk"{f'U'J ID-19 

### -V9 Chemistry-Toxicology

### Team (CTT) Efficacy and Science Support Branch (ESSB) Karen 

### P. Hicks, CTTeamLeader 

### Efficacy and Science" SupportBranch Antimicrobials Division 

### (751oc) 

# .rhm: Michele E. Wingfield, Branch

### Chief Efficacy and Science SupportBranch Antimicrobials Division 

### (751OC) Ba,j::J<.oJI.JJum_ci .'

. d ' 

## -r,**~** 7r

- d

### 0~c-t 

# ,:s.**5-"Mn-<.~~** h,{!,C'UUC-O' 7lrti/]U

. 

### ",,,,i/i<.;;f

### ,pu'~J

## ~**~ ~oM7c2f:'**  

# -JrciLJ'71h Of- H1r'J/zttA.

### SUBJECT: PRODUCT CHEMISTRY REVIEW

- Antimicrobials Division DP Barcode D259559 Reg. No. OrFile Symbol 1706-RJU Manufacturing-Use [lorEnd-Use Product [Xl Case # TO: Robert BrennislMarianne Clark 

### PM Team No. 32 FROM:

THRU:

THRU: Anna Skapars, Chemist 

### Chemistry-Toxicology Team (CTT) Product Science Branch (PSB) 

### Karen Hicks, Team Leader Chemistry/Toxicology Team (CIT) Product Science Branch (PSB) Michele E. Wingfield, Branch Chief 

### Product Science Branch (PSB) SUMMARY OF INFORMATION REVIEWED AND FINDINGS
BACKGROUND: Registrant is submitting updated manufacturing process, label and Confidential Statement 

### ofFonnula. FINDINGS: Revised Confidential Statement 

### ofFonnula dated 9/9/99 is in compliance with 40 CFR Part 158.175, 

### it 

### agrees with the label and CSF is acceptable. However, please note that 

### the certified limits ofthe active ingredient should be calculated on the nominal concentration, not the percent by weight. Certified limits for active and inert ingredients comply with 40 CPR Part 158.175 and they are acceptable. Upgraded manufacturing process, no MRID No. Assigned, is in compliance with 40 CFR 

### Part 158.155 through 158.165 and it satisfies product chemistry data for Guideline

Series 61.


### RECOMMENDATION: This formulation is not cleared by FDA for use in manufacture offood grade paper and paperboard products.) 

### Please update CSF at next printing to show correct certified limits for the active ingredient. A name and address is required for all suppliers. Please correct CSF at next printing to indicate such. For use ofthis product in manufacture offood grade paper or paperboard products registrant should ask FDA for an Opinion letter or label should have disclaimer statement ''not for use in manufacture offood grade paper".DP BARCODE, D259557 CASE, 064909 SUBMISSION, S568516 DATA PACKAGE RECORD BEAN SHEET DATE, 09/20/99 

### Page 1 of 1 

## * 

## * * CASE/SUBMISSION INFORMATION 

### * 

## * 

## * CASE TYPE: REGISTRATION ACTION: 187 RESB AmD-OC-MINOR CHG CHEMICALS: 013907 Sodium bromide 014703 Sodium hypochlorite ID#, 001706-RIU TX-10861 COMPANY: 001706 NALCO CHEMICAL CO. PRODUCT MANAGER, 32 ROBERT BRENNIS 

### PM TEAM REVIEWER: MARIANNE CLARK RECEIVED DATE, 09/15/99 DUE OUT 703-308-6264 703-308-6381 DATE 

## .Ji1l%LJiZj;y'iRiO;:; 

## * 

## * * DATA PACKAGE INFORMATION 

## * * * DP BARCODE, 259557 EXPEDITE, N**t~HEMICAL:** 013907 DP TYPE: 001 Sodium bromide CSF, Y LABEL: Y DATE SENT, 09/20/99 ROOM, CS1 ROOM, CS1

DATE RET., 13.6600% 9.4100%

6C 6W44



### / 

### /
ASSIGNED TO DATE IN

DIV : AD 

## 'i /.;Jp/f 1 

### DATE 

### / / / / / OUT 

### / ADMIN DUE DATE: NEGOT DATE,

PROJ DATE, 12/24/99 

### / / BRAN, PSB C; /..) '/f 

### 7 SECT, CTT 

### 7/07</f f REVR

### '1fo.-~ 

## 'l'/dqq CONTR: / / 

### / / / / 

## * 

## * * DATA REVIEW INSTRUCTIONS 

## * * * Actue Tox: Please review registrant's resubmission for a waiver from acute toxicity data. Registrant is citing EPA file symbol 1706-179 as being identical label 

### & CSF attached. 

## * 

## * * DATA PACKAGE EVALUATION 

### * * * No evaluation is written for this data package



### * * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION 

### * * */ 

### /

DP BC 259559 BRANCH/SECTION PSB/CTT DATE OUT 09/20/99 DUE BACK 12/24/99 INS Y CSF Y LABEL Y

### DP BARCODE: D259557 CASE, 064909 SUBMISSION, S568516 DATA PACKAGE RECORD BEAN SHEET DATE, 09/20/99 Page 1 of 1 

### * * * CASE/SUBMISSION INFORMATION 

### * * * CASE TYPE: REGISTRATION 013907 Sodium 014703 Sodium ACTION, bromide hypochlorite 187 RESB AmD-OC-MINOR CHG CHEMICALS, IDff, 001706-RIU TX-I0861 COMPANY, 001706 NALCO CHEMICAL CO. PRODUCT MANAGER, 32 ROBERT BRENNIS PM TEAM REVIEWER, MARIANNE CLARK RECEIVED DATE, 09/15/99 DUE OUT DATE, 703-308-6264 703-308-6381 01/13/00 

### * * * DATA PACKAGE INFORMATION 

### * * * DP BARCODE: 259557 EXPEDITE: N ''CHEMICAL: 013907 Sodium bromide DP TYPE: 001CSF, y 

### LABEL: DATE SENT, 09/20/99
Y 

### ROOM, CSI ROOM: CS1

DATE RET. : 13.6600%" 9.4100%"

6C 6W44



### / /

ASSIGNED TO

DIV : AD BRAN, PSB SECT, CTT REVR , CONTR, DATE IN DATE OUT ADMIN DUE DATE: 12/24/99

DP BC 259559

• 

### / 

### / / / NEGOT DATE, 

### / / / / PROJ DATE, 

### / / / / / / / / / 

### / / / 

## * * * DATA REVIEW INSTRUCTIONS 

## * * * Actue Tox: Please review registrant's resubmission for a waiver from acute toxicity data. Registrant is citing EPA file symbol 1706-179 as being identical label 

### & CSF attached. 

### * * * DATA PACKAGE EVALUATION 

### * * * No evaluation is written for this data package



### * * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION 

### * * */ 

### /

BRANCH/SECTION PSB/CTT DATE OUT 09/20/99 DUE BACK 12/24/99 INS Y 

### CSF Y 

### / 

### /

LABEL Y

### \ NALCO CHeMICAL COMPANY

Mr. RobertBrennis U.S. EnvironmentalProtectionAgency Antimicrobial Division (7510W) 410 M. StreetSW Washington, D.C. 20460 September9,1999

Subject: Resubmission ofApplication for Registration Nalco TX-10861 (1706-RUI) Dear Mr. Brennis: Nalco Chemical Company submits this letter inresponse to your letter datedJuly 23, 1999 in which you define certain deficiencies in the original application. We have included thefollowing items inthis application: 1. AmendedEPA Form85704 2. Updated labelwith pasteurizer claims deleted 3. Amended ConfidentialAppendix (corrected manufacturingprocedure) 4. Documentation to substantiatepulp & papermilluse patterns Regarding the acute toxicology waiverissue, the cited productshould have been 1706-179 (Nalco 95ND141). This product, TX-10861 is essentially a "double strength" 95ND141. Wereiterate the request for waiver below. Nalco Chemical Companywishes to request a waiver from acute toxidhjdata requirements (Guidelines 81-1 through 81-6) on the basis that the formulation is essentially identical to the registeredproductNalco 95ND141 (Reg. No.**1706~179).** Theprecautionanjstatements on the label will be identical to those jor Nalco 95ND141. Also, because of the very dose similarity to 1706-179, Na1co Chemical Company believes this application should qualify for "expeditedreview" as a "me-too" product. We await a copy of the "stamped accepted" label. Ifyou have any questions, please feel free to contact me directly.

# t9~~~**~;!.** Wolf, MSc., <.-... CorporateToxicologist 

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### ,

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### I

j FOOD AND DRUG STATUS INGREDIENTS OF NALCOI0861 FOR USE IN PAPERMlLL INFLUENT AND PROCESS WATER SYSTEMS

INGREDIENT SodiumHypochlorite Sodium Bromide FDA CITATION 2ICFR176.170 

### FDA Letter up to 22 ppm in

### water (as Br+ ion) GRAS affirmed under



### , 

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# . , , " , ,21 CFR Ch.1 (4-1-97 Edition) Limitation. _n! eel p<ior 10 lhe st\OOl..form- For use only as a fIcx>:;uIanl 0
..",,01 and**~rd,**

ing "I*alion In Ih<l**maoot",:~~ ~~~**  )10 parts per milaOO used al a \<I
..... 001 10 ex"""" "'101'**~ ~on}**  01 innuent wa\i)l'. 

# , • "**~oyed** in the manubcWro 01 ,I- For use or.ly as**a~_~~~I** 

### ':0 the shOOt.formlng ope<aUon, 01 paper 1.00 p3!lOlll<>OUY

...,0( 

### • 

## " " 

## "

lana 

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# _.**,~** 

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# ""

100 Food and Drug Administration, HHS Lisl 01 S4Jbstanc:es Poiyfo){),clhylvoo (dimolh)'llmlnlo) elhylene )dimclh)'liminio)

elhyfene didolorid&) produced by reacting oqulmGlar QiJII.I>-**~li...** 01 N,N.N.N-iolramelhyfelhy\ene4lamlrKI and dichlorelhyl ether 10 )'laid a $CMion 01 Ihe sotid potymer in**diMi~od** water at 25' C with a rcdooad viS<:o.ily 01 no! loss lhan 0.15**deci~Ier** per (lfam as determined by ASTM melhD(! 01243-79, "Slaodllfd T8$I Melhod lor .DiMe ScIullO<! Vis· cosil)i 01 Vin)'! ChI<)I"Ide**Po~me(S."** which is ifIco(paralod by relll(ellCe. Copies may boo obIairKld Itom lhe American Sod·**e~** tor TGSting Materials. 1916 Race St.,**Phi~lphia.** PA 19103, or m"l' boo e..",.,ined al lhe Otfooo 01 Ihe Federal Rogi$lll(. 800 Ncrtll Capitot SlrOOl, toW ••**su~"** 700. WashinaIon. DC 2G400). The totlcwing**Iormu~ ~**  used lor deletml

..... ing rcdOOlld vi=rty:.

Roducod visaW!y In lerma 01**docil~o'(S** per gram.)I-Io)1

)I-C}. where: ,..SGIution emux time t"..Water efflux time C-CoJ>Cllnlration 01 sotution In lorms 01 gram. per OOQliler Polypropykooo glycol )minimum moloeu!ar weiijllt 1,0(0). Potasaium persultate. 2·Propono;c acid, telomM wilh sodium 2·m!!lh)'!·2·1(I-oxo-2.

prcpon)'l)amino)·I-propane sultonale and sooiurn pIIosp/liroale (CAS Rug. No. 110224-119-2). Ptop)'lGOO glycot oIgInete. Prolo;n hydro\y!;ate lrom animal hides or soyboan p<QInin 00

.....

densed wlth oteic and/or slearic add. Rapeseed <)ii, sulfated ammonium. pola$Sium. or sodium**sa~.** Ricobrnn 011. sultaled ammonium,**~m,** or sodium sail. ROllin aOO roon derivatives •..•_.•.•..•..•.•...•..,.••.., .._...................... S<fver chtorlclfK::ollted tilaroium dfoxi<le _...................................... Sooium COfboxymethyt guor gum having a minimum**visoosi~**

012,700 oentipoises at 25·C alter 24 nours lIS dOlorminocl by RV-seoies Brookfield visoomclO( (or eQIIiwlent) using a No. 4 spindle 11120 r.p.m. and uaing p tIlot sampja prepared by dissolving 8 grams 01 sodium carbcxymothyl guar gum in 392 milfimers 01 0.2i>\1fC(!nI-tly-welghl aqueous "","um (>0 pIlon)'!phenatp soIulfon. Sodium dioct)'l wttowc:cinalc. Sooium Iormaldehyde wtlo,,),hlI0

............................................... Sooium hypocht<llile, SocIi"", N-meth)'l-Notc)'ltauralo .•.•...•.•..•...•.•.,............................ Sodium nibilli ....•.•.•.•...,.,.,..............

Sodium persuHala. Sodium poIyacry;ale •.,.,.,..............................................._"
.........

Sodrum**poI1~soprDp!!nyIphosphonole)** )CAS Reg. No. 118632-

18-1). Sodium 'inc po!a$Ei"", poI)l!)hasphaie (CAS Reg. No. 65997-

17-3). Spoon oil. wttatod, ammonium, pol.lJ;N/\XIl, or sodium sail. Stannous ole,le. SteaI)'l·2-lcetytic acid aOO its calcium**sa~.** §176.170 Limitations For uso only 10 imprcMl dry-slrength 01 paper ar.cI poporboard

aOO 811
.. retllnti<ln IIIld dralnage ald amptoyod plio( KI the sh&et..formlng operatlon In IIle marn.lfactur. 01 paper ar.cI paperboard and**~m~ed** 10 un at Ii lew! nat Ie exceed 0.1 per_ OIInl by weight 01 the fini.hed dry I"'P"'" ond pgpoIboard fibers.

For usc onf1 11$ a depos.l controt additiVtl omptoyod prior 10

Ihe shool forming Dp!!raticn In**~** manufacture 01 paper and paperboatd and II ale

..... nol 10 o.oood 0.15 perwnI by weight ot \he dry paper and poporbonrd

As fl'<lvidod in § I78.3871) 01 INs diopter. For uso ooIy 81 a pr.....rvatiVtI iii poI)'!MI' latex**u~** at..

le';ef nel 10 exooed 22 parIS per million (ba&ed on sItvar Ion**oollCenll'a~oo)** in the dry coating. For use onf1 81 a dry-slrength and IotmaIicrHid agent emplo1ed prior 10 the sheel·lorming opcrillion in \he mcnulaolIIte 01**~** and pcpotboord and used III

### °leVtIt not 10 ex_ ooed 1% by Wtiighl 01 finished dry poppr or peporboo.vd t!- 000.

For**~** ont1 as potym(trization co.toIyst. For use ooIy II!l an**a~I** 10 con\rot pUp ab$Orbency and

pilch contenl in the manufactlJro 01 paper and paporbOIlrd prior 10 lno shool·lorming ope<atlon. For uso 001)': t. At \evefl; nol 10 exccod 02% by weigh! 01 lubricants or r....

lease agents appIiocl 01 IB'I'IIlII not 10 cl<CCOd 1 lb. per IQn 01 finishQd paper or PllPl'rboMl. 2. As an anticorroIikln ag&l1I at levtils not Ie el<OlOO' 0.2% by

wCiijllt 01 wax amlll;lO<lll USI!d as !ntcmal sizing In \he manulaclvte 01**~** and papo<boartI prior 10 the shcel..fonn/ng operation. For

## til, only: I. As. thickening agent lor nalllril! rubbor latex OOIIlinQ1, proYiOed II is used at a levtil 001 to ClCCCed 2 perwnt by weighl 01 coating .soIOds. 2. As • pigmcnl dis;IotsanIln <:OIIIings at a Iovot not 10 excaad

025 pon;enl by woighI 01 pigm&nI. For u.n ooIy in paper mill boilers. For use ooIy as a pigmiJn\ dispersatll in coatings al a level no!

10 exooed I per<:ent by weigh! 01 pig",..,nl.


### 191

# , (4

DEPARTM.ENT OfHfALTH & HUMANSERVICES

# ~ -. , ,/.1- Public Health Servico 

## .J<'-e..**~e't':r** 

# . Nil5Ql Foot;S anCl Orug Admlni$ttatiet"l W.shington OC 20204


## Dr. Lanny Lake International Chemical Consultants 5520 Cherokee Avenue, suite 200 

### •Alexandria, VA**~2313**

Dear Dr.. Lake: 

### This is 

### in response to your**~etter** 

### of November 1, 1990# and 

### the subsequent meeting of November**1~,** 

### 1990, 

### regarding your request for our consideration of SOdium bromide for use as a slimicide. You stated in your letter that sodium bromide would be used at pulp and paper mills to control algae, bacterial, and fungal slime that exist 

## in the various process water systems of pulp and paper mills. We have reviewed your submission and find that 

### with a 

### maximum addition level of 22 

### parts per million (22 

### ppm) bromide ion in the process water,**th~** 

### bromide ion residua 

### in**food~coneact** 

### paper would be no greater than 1 

### part per billion (ppb), and 

### the dietary exposure to bromide ion would be far**bel~~** 

### this level. On the basis of your stated maximum app1icaeion level of 22 ppm**bro~ide.1on** 

### in prooess 

### water and the minute exposure expected in 

### the 

### diet, we conclude that the intended·use of sodium bromide would not require 

## a petition to 

## FDA to amend the food additive regulations. We wane to**~Fhasize** 

### that 

### all s1imicid6S must be registered 

### with the Environmental Protection Agency (EPA), and that under the Federal Insecticide, Fungicide and Rodenticide Act (FrFRA) **I** 

### efficacy data may be required. For more 

### information regarding EPA registration procedures, you may call the EPA 

### Hotline at:**.20~-382~5~2~** 

### (looal) 

### or 1-800-426- 

### 4791 (long 

### distance). sincerely yours,

# AI~BIJ-.l---,;. Alan Rulis, 

## Ph.O. Director , " " 

### ,

, , , , 

### Division of Food and color 

### center for 

## FOod Safety**Addieives!~~:~!** 

### and Applied Nutrition " 

# . 

# .

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### SUBMISSION BAR CODE 

# #,g!)P/360 REVIEWER 

# II. CltfAJ,G

FILE SYMBOL.,/

# 'R=E~GG~::J~;-:i2~U~iP~M~'-~2:.22~=AC~T~I~O=N~C=O=D=E~**j,:f)~6~** ,DESCRIPTOF(
_ '[ ] 'CHILD RESISTANT PACKAGING: [ ] CERTIFICATION [ ] NON-RESIDENTIAL USE ONLY [ ] NOT APPLICABLE REGISTRATION TYPE: ,[ CONDITIONAL [ 

### UNCONDITIONAL PROPOSED CLASSIFICATION,: [ ] GENERAL [ RESTRICTED USE DATE'ON APPLICATION EPA RECEIVE DATE PM "RECEIVE 'DATE 

# [Of 1

# VB 1 

# qq I METHOD <iF SlJPPORT , [ ] CITE-ALL [ ] SELECTIVE " [ ,] NOT SUBMITTED [ J_NOTAPPLI,CABLE 

# [ r INCORRECT/RESUB 

# 1041&71991

, 

### , 

### FORMULATORS EXEMPTION []-SUBMITTED [ ] NOT SUBMITTED

, [ ] NOT APPLICABLE

[ '1. 

### INCORRECT/RESUB 

# I JEVIEW (S] REQUESTED DATA PACK # 

### riATE SENT DUE DATE DATE RETURNED , "


### CHEMISTRY EFFICACY TOXICOLOGY HED TOX. ENVIRON. FATE FISH/WILDLIFE OTHER ___ -'-__ _ '" 

# DJS5'G50 

# Lf**I~**

### DdS5~lj'

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# ( 'fr**7{~dr;9** S-/(O 

# iq9 

# Iq« 15- 

## f<{ 

## 'ff( 

# 7 'I'!

# Iqq

.

STATUS.
__

## ---~----_------------------~~--------~
RESPONSE CODE 

# ;3 RESPONSE DATE 

# 'v JUL 

## 2. 3 

## \999.M '

### ( 

## , )



# I

SYMBOL.

SURNAME UNITED STATES ENVIRONMENTAL PROTECTION AGENCY



### Mr. Claude 

### H. Wolf Nalco Chemical Company One Nalco Center Naperville, Il60563 Dear Mr. Wolf: Subject: TX-I086 EPA Registration No. 1706-RIU Application DatedApril 8, 1999 

## .Ill! 2 3 1999

The application for registration ofthe subject product is not yet acceptable for registration for the following reaSOns. The Confidential Statement ofFonnuladated April 8, 1999 is not acceptable. Based onyour Confidential Statement ofFormulathe label claim for Sodiumbromide shouIa be 13.40%. Note that source product for Soditun bromide
Submit an opinion letterfrom Food and Drug Admininstration that this product, ''TX-I0861'' may be safely used in the above uses (Industrial pasteurizers

- food and beverage) Industrial process pasteurizers; shell egg pasteurizer water system; pulp and papennill influent water systems; and pulp and papennillprocess water systems. All of ofthese uses must be approved by the Food and Drug Administration (FDA). EPA File Symbol 1706-RnJ is not substantially similar to EPA Registration Number 1706-171 in tenns ofacute toxicology. This means that the fonnulations of 1706-RID and 1706-171 are not similar enough to allow studies conducted on either one ofthese products to be cited to support the acute toxicity (product toxicity) requirements for the otherproduct. The main problem is that EPAFile Symbol 1706-RIU contains 13.66% sodium bromide. According to the label and Confidential Statement of Fonnula ofRegistration No. 1706-171, itdoes not contain any sodiumbromide. Thus, the Efficacy Science SupportBranch will not allow acute toxicity data developed or derjved from RegistrationNumber 1706-171 to be used to support any ofthe six acute toxicity requirements for file symbol 1706-RlU.
CONCURREHCES



# . 

# ...**-.~.:~**

# ......................................................................'

# ..........................................................................
DATE 

## - i

...;;,...**~**

## ...........**~.................** 

## ................. . ..**~**

## ...................................**~**

## .................-........**~**

## ........................ OPPICIAL PIU:; COPY

### 2 Your application can not be processed until the above materials are corrected. 

### This product may not be lawfully distributed or marketed until it is registered. Ifyou have any questions, please call Marianne Clark at (703) 308-6381.

# ?~~v~ Robert S. Srennis Product Manager (32) 

### Regulatory Management Branch II Antimicrobial Division (7510C)

### DP BARCODE, D255651 CASE, 064909 SUBMISSION, S561360 DATA PACKAGE RECORD BEAN SHEET 

## * * * CASE/SUBMISSION INFORMATION 

### * * * DATE, 04/29/99 Page 1 of 1


### CASE TYPE: REGISTRATION ACTION: 186 AmD-OC-MINOR CHANGE CHEMICALS: 013907 Sodium bromide 014703 Sodium hypochlorite 

### ID#, 001706-RIU TX-10861 COMPANY, 001706 NALCO CHEMICAL CO. PRODUCT MANAGER, 32 ROBERT BRENNIS PM TEAM REVIEWER: MARIANNE CLARK 

### RECEIVED DATE, 04/16/99 DUE OUT DATE, 703-308-6264 703-308-6381 

### 08/14/99 

## * * * DATA PACKAGE INFORMATION 

### * * * ROOM, CS1 ROOM: CSl 13.6600% 9.4100%



### 6C 6W44**~P** 

### BARCODE, 255651 EXPEDITE, N MEMICAL: 013907 Sodium bromide 

### DP TYPE, 001 DATE SENT, 04/29/99 DATE RET., / 

### /
ASSIGNED TO

DIV , 

### AD BRAN, EASSB SECT: CTT 

### REVR 

## c&.-- CONTR, CSF, Y LABEL, Y DATE 

### / / / / / OUT 

### / / / / / ADMIN DUE NEGOT

PROJ


### * * * DATA REVIEW INSTRUCTIONS 

### * * 

### * DATE, DATE, DATE, 08/02/99 

## 7//1 /q;"( 

### / 

### /

Acute Tox: Please review registrant's request for a waiver from acute toxicity data requirements



### DP BC 255650 

## * * * DATA PACKAGE EVALUATION 

### * * * No evaluation is written for this data package



## * * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION 

### * * * BRANCH/SECTION EASSB/CTT DATE OUT 04/29/99 DUE BACK 08/02/99 INS Y 

### CSF Y LABEL Y

### DP BARCODE, D255651 CASE, 064909 SUBMISSION, S561360 DATA PACKAGE RECORD 

### BEAN SHEET DATE, 04/29/99 Page 1 of 1 

## * * * CASE/SUBMISSION INFORMATION 

### * 

### * * CASE TYPE, REGISTRATION ACTION, 186 AmD-OC-MINOR CHANGE CHEMICALS: 013907 Sodium bromide 014703 Sodium hypochlorite 

### ID#, 001706-RIU TX-I0861 COMPANY, 001706 NALCO CHEMICAL CO. PRODUCT MANAGER, 32 ROBERT BRENNIS PM TEAM REVIEWER: MARIANNE CLARK 

### RECEIVED DATE, 04/16/99 DUE OUT DATE, 703-308-6264 703-308-6381 08/14/99 

## * 

## * * DATA PACKAGE INFORMATION 

### * * ***~p** BARCODE: 255651 EXPEDITE: N HEMlCAL: 013907 Sodium bromide 

### DATE SENT, 04/29/99 DP TYPE: 001

### CSP, Y LABEL: Y 

### ROOM, CSl ROOM, CSl

DATE RET.: 13.6600% 9.4100%



### 6C 6W44


### / /

ASSIGNED TO

DIV : AD 

### BRAN, EASSB SECT, CTT REVR , 

### CONTR, DATE 

### IN DATE OUT ADMIN DUE DATE, 08/02/99

DP BC 255650 

### / / / / NEGOT DATE: 

### / / / 

### / / PROJ DATE, 

### / / / 

### / / / 

### / / / 

### / / / / 

## * * * DATA REVIEW INSTRUCTIONS 

## * * * Acute Tox: Please review registrantls request for a waiver from acute toxicity data requirements 

## * * * DATA PACKAGE EVALUATION 

### * * 

### *

. No evaluation is written for this data package



## * * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION 

### * * 

### * BRANCH/SECTION EASSB/CTT DATE OUT 04/29/99 DUE BACK 08/02/99 INS Y 

### CSF Y 

### / /

LABEL YUNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, 

### D.C. 20460

July 14, 1999 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM: Subject:

To:

From:

Through:
Applicant: Similarity Clinic Determination: 1706-RJU/ TX-10861 DP Barcode: D255651 CaseNo: 064909 Robert Brennis, PM 32 / Marianne Clark Regulatory Management Branch Antimicrobials Division (751OC) AD Similarity Clinic () 

### .iJ /P 

# d 

# d! Ian Blackwell 

### UC/lV

# ~,~ Efficacy and Science Support Branch Antimicrobials Division (7510C) Michele Wingfield, BranchChief

# ~**~7~** Efficacy and Science SupportBranch 

# "0 Antimicrobials Division (751OC) NaIco Chemical Company
This Similarity Clinic Determination is meant to decide 

### iftwo or more pesticide products are able to cite the same acute toxicity data. In many instances, the data cited was conducted using one of theproducts which is involved in the determination. This Similarity Clinic Determination only pertains to acute toxicity studies ofend-use products, not to any other types ofstudies. EPAFile Symbol 1706-RJU is not felt to be substantially similarto·EPAReg. No. 1706-171 in terms ofacute toxicology. This means that the formulations of 1706-RIU and 1706-171 are not similar enough to allow studies conducted on either one ofthese products to be cited to support the acute toxicity (product toxicity) requirements for the other product. The main problem is that reg. no. 1706-RIU contains 13.66% sodium bromide. According to the label and CSF ofreg. no. 1706-171, it does not contain any sodium bromide whatsoever. Thus, ESSB will not allow acute toxicity data developed or derived from reg. no. 1706-171 to be used to support any ofthe six acute toxicity requirements for file symbol 1706-RIU.

# I DP BARCODE, D255650 CASE, 064909 SUBMISSION, S561360 DATA PACKAGE RECORD BEAN SHEET DATE, 04/29/99 Page 1 of 1 

### * 

## * * CASE/SUBMISSION INFORMATION 

### * * * 186 AmD-OC-MINOR CHANGE CASE TYPE, CHEMICALS, REGISTRATION 013907 Sodium 014703 Sodium 

### ACTION, bromide hypochlorite 13.6600% 9.4100% 

### ID#, 001706-RIU TX-10861 COMPANY, 001706 NALCO CHEMICAL CO. PRODUCT MANAGER, 32 ROBERT BRENNIS PM TEAM REVIEWER, MARIANNE CLARK RECEIVED DATE, 04/16/99 DUE OUT DATE, 703-308-6264 703-308-6381 08/14/99 

### * 

## * * DATA PACKAGE INFORMATION 

### * 

### * * ?P BARCODE, 255650 EXPEDITE, N DATE SENT, 04/29/99 2HEMICAL: 013907 Sodium bromide 

### DP TYPE, 001CSF, Y LABEL, Y ASSIGNED TO DATE IN DATE OUT

DIV , AD 

### i'/"">/"77 / / BRAN, EASSB 

### i'/a"/fc / / SECT, CTT 

### Y

## /3,,/,; / / REVR ,/1.scl1M£5 

## r-/3 /!',r / / CONTR, 

## Cnvr.lA./

# Lp.o.J / / / ADMIN DUE NEGOT

PROJ

S- /0- 

### q 

## It * * * DATA REVIEW INSTRUCTIONS 

### * 

## * * ROOM, CS1 ROOM, CS1

DATE RET., /
DATE, DATE, DATE, 08/02/99 

### / / / /

Product Chemistry: Please review CSF, label and chemistry data MRID#s 448082-01 

### & 02 submitted to support registration of subject product



### DP BC 255651 

## * * * DATA PACKAGE EVALUATION 

### * * * No evaluation is written for this data package



## * * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION 

### * * * BRANCH/SECTION EASSB/CTT DATE OUT 04/29/99 DUE BACK 08/02/99 INS Y 

### CSF Y 

### 6C 6W44



### /

LABEL Y

### DP BARCODE: D255650 

### CASE, 064909 SUBMISSION, S561360 DATA PACKAGE RECORD BEAN SHEET DATE, 05/04/99 Page 1 of 1 

## * * * 

### CASE/SUBMISSION INFORMATION * * * 

### CASE TYPE, REGISTRATION ACTION, 186 AmD-OC-MINOR CHANGE CHEMICALS: 013907 Sodium bromide 014703 Sodium hypochlorite 

### ID#, 001706-RIU TX-I0861 COMPANY, 001706 NALCO CHEMICAL CO. PRODUCT MANAGER, 32 ROBERT BRENNIS PM TEAM REVIEWER, MARIANNE CLARK RECEIVED DATE, 04/16/99 DUE OUT DATE, 703-308-6264 703-308-6381 08/14/99 

## * * * 

### DATA PACKAGE INFORMATION * * * 

### DP BARCODE: 255650 EXPEDITE: N rHEMICAL: 013907 Sodium bromide 

### DP TYPE, 001CSF, Y LABEL, DATE SENT, 04/29/99 Y ROOM, CSI ROOM, CSI

DATE RET. : 13.6600% 9.4100%



### 6C 6W44



### / /
ASSIGNED TO

DIV , AD BRAN, EASSB SECT, CTT DATE IN DATE OUT ADMIN DUE DATE, 08/02/99



### ) REVR , ASKAPARS

CONTR, 04/29/99 04/30/99 04/30/99 05/03/99 

### / / 

## * * * / / / / / DATA REVIEW 

### / NEGOT DATE, 

### / PROJ DATE, 

### / / / INSTRUCTIONS 

### * 

## * * Product Chemistry: Please review CSF, label and chemistry data MRID#s 448082-01 & 

### 02 submitted to support registration of subject product 

### * * * 

### DATA PACKAGE EVALUATION * * * 

### No evaluation is written for this data package



## * * * 

### ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION * * *

### / /

DP BC 255651 BRANCH/SECTION EASSB/CTT DATE OUT 04/29/99 DUE BACK 08/02/99 INS Y 

### CSF Y 

### / /

LABEL YSUBJECT:



### TO:
FROM: 

### PRODUCT CHEMISTRY REVIEW - Antimicrobials Division DP Barcode 

### D.:lS5&50 Reg. No. or File Symbol 

### 170"

- 

### RJ'tt -Manufacturing-Use [ ] or End-Use Product [ 

## vi Case#__



# /Chi**~~** 

# / MqJu!YMz<, 

# ('.-iOA.k. PM Team No. 

### 3;), 7 Anna Skapars, Chemist 

# 11(7n CL 

# .5'*atUUi Chemistry-Toxicology Team (CIT) 

# I Efficacy and Science Support Branch (ESSB) **5-10- 99** 

THRU: Michele E. Wingfield, Branch Chief 

### Efficacy and Science Support Branch (ESSB)



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### PRODUCT CHEMISTRY REVIEW END-USE PRODUCT 

# [v) MANUFACTURING-USE PRODUCT [ 

### 1 EPA Reg. No. (or File Symbol No.) 17126- 

### RIl/ Registration 

## [v) Reregistration [ 

## 1 Case No.: 7):').556S0 DP Barcode/chemist: 

## IInne>.. Skrall4 

### 1) 3) 2) 4) 1. 2 • 3. 

### Product Name: 

# TX-**(D"s~1** company: 

# N QttAl ('

## ~~ 

# Co. Type of Submission: New [;] Resubmission [] Alnendment [ ] 

### "ME-TOO" [ ) 

### Expt Use Permit [ Alternate Formulation [ 

### 1 REPACK [ 

### 1 1 Other (Specify)
______________________ __ 4. CONFIDENTIAL STATEMENT OF FORMULA 4a. Type of formulation and source registration
• Non-integrated formulation system



### . Are all TGAIs ·used registered 

### • yes 

# [.1 • no 

### Integrated formulation system [

4b. 

### • If "ME-TOO", specify EPA Req. No. of existinc; product: 

### Clearance of inerts for non-food or food use: Cleared for food use under 40CFR§180.1001: 

### • yes [ 

### 1 • no [ 

### 1. If 

### yes: • c 

### [1 • d [ 

### 1 Cleared for non-food use: . yes [/]


### 4c. Physical state of product:

# cf3..·'t'""~'L • e [ 

### 1 • no [ 

### 1

4d. The chemical IDSJ 

### analytical information (including that for the TGAIs), density, pH, and flammability are consistent with that given in GRN 61, 62, and 63-7, 63-12, 

### and 63-15, 

### respectively. • yes 

# [/J
. no [ 

### 13 

### 4e. Dens-ity (or bUlk denslty for solids): 

### at 4f. pH **(if** 

### dissolved or dispersed in water) t 

### Itf 4g. Flash pOint and/or flame extension: 

# None...., 4h. 4 

### i. Nes and CLs are acceptable\ 

### Active ingredient(s) A. 

## Socl{'-tl/Y>'-' li;'fFc),AUiL B. 

## Sod<'."",u &;,.;;ffU'dc. C. 

### D. 

# . ( ) 

# . not acceptable ( ) NC. LCL UCL 

### "1.4/ t,90 I";J.I?



### 4j. For products produced by an integrated formulation 

### system:
• All 

### impurities of toxicological significance have 

### an UCL: • yes () • no () • not applicable 

# (v1
• All impurities**~** 

### 0.1% in 

### the product have been 

### identif,ied<· yes'( ) '. no () • hot applicable (,.-f

S. 

### PRODUCT LABEL Sa.
Sb.



### Sc. 

### The active ingredients statement**(chemical~IDs** 

### Nes) is consistent 

### with the 

### CSF: • yes 

### [Y] The formulation conta.ins one of the following: • 10\ or more of a 

### petroleum 

### distillate: • yes ( ) • 1% 

### or more of methyl alcohol: • yes ( ) sodium nitrite at any level: • yes [ J 

### · a toxic List 1 inert at any level:- yes [ J 

### • arsenic in any form: • yes [ J 

### and • no ( )



### • no

## (~ 

# :**~~**

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no 

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### • yes ( ) any of the above, does the inert ingredients contains a footnote indicating this? 

### • no ( ) • not applicable (J) 5d. The appropriate warning statement regarding 

### flammability or explosive characteristics of the product**~re** given on the label: 

### • yes (/]' • no ( ) • not applicable ( )

## , 5e. The storagj!
__**and-.dis.po,s_a:r~_t-l_st-ru-e_t_i_ons_f-or_** 

### the pesticide ----and 

### ·container are in compl iance with PR Notice 84 -1 for household use products or PR Notice 83-3 for all other 

### uses: • yes 

## [v'J • no [ 

## J 6f. Does the product require an expiration date at Which time the NC falls below the teL (based on the one year storage stability data or other information): 

### • yes [ 

### J • no 

## [v:l
6. 

### PRODOCT CHEHIS1RY (GRN 61. 62. 631



### 6a. 

### Chgmical IDsLManufactureLAnalytical Acce12t 

## ot Mlilll Infgrmation Information 

### H2... 61-1**Chernica~** 

### ID 

### (see Appendix) , 

## A 4'1-&0&;/"01 61-2a Manufacturing Process2 

## A 44%08;;-0 

### 61-2b 

### Formulation Method3, 

# A '-Itt'**f{Nf~-** 

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### Discussion of Impurities' 

# A- 44Z08;J-O 62-1 

### AnalysisS 

# AliA62-2 

### Certified Limits 6
. 

### - 

# A -&sF

- 62-3 

### Analytical Method for A1s7 

## A 'f'f871 111**-o~**5


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.., ,('C) 10 

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### 1

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# T 11 

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### 63-19

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### solvents)" 

# 1\ "WI", A, -[)/ 

### 63-20**corro~tvitY** 

### ( ", metals, ""ions) 

## A

# Ii:~£~>,;. w**'~?j'a** (J' 

### 63-21 ni" 

# .::t;k Breakdown 

# v;;i Nh 

# 14. Explanaticn,; A •**Acc.ptabl.~** N • net acceptable, NA • tecbnically not applicabl.; G • data 9ap: U • require. upgrading; W• yaived; E • EPA ••timat•• FootD91": 1 s•• Confid.ntial appendix A for additional informaticn; Z For HP/Er product. produced by an integrated for=ulation .y.t••; J For product. produced from I TGAI or HP; , May b. 

### yaived unl••• actual/po.,ible impuritiel are of**~o~** CODcern; ,**ri~e** batch analy.i. required for producte produced by an**integr.~.c** formulation .y.te.; , If different from .tandard ctl recomm.nded in 40 CrR 15'.175, this .bould be di.cu••ed in Confidential Appendix A; 7 Abbreviate metbod u.ed" a. follovez ga. chromAtography (Ge), infrared (IR), ultraviolet ablorption (UV), nuclear =agnetic re.onance (NKk), etc. '**Pro~ide** brief de.cription, e.9., color _ yellov er property**~alue,** e.9. denlity 1.,25 g/cc. Unle.1 otberwi.e indicated, thl property sbould b. at 25 C ; t If" product i, a water .olution or disper.ion; 10 Not required for aerolol.: 11 EmulsUi&bll liquid. only; 11 ror end-u•• product. u.ed near electrical
. •quipment.

C:C:I**J.o~h"'1""** No. oad COIlUal ruo 110,. No. or "ou, Can )1"0.) .750SVtlDtlSll'CUICSe "llRu:=th.,io..n" Ma_t'tTPhC IllicioletDIu.I'Ot10Je)O'e:u:;:a;tCOdo (10,01' aero, Mol. <pcrOQCio " 

# 1

# / NALca CHEMICAL COMPANY rJ"lc. ":,.,,'.,(; l.:1 "J1FH

Mr. Robert Brennis U.S. Environmental Protection Agency Antimicrobial Division (7510W) 410 M. StreetS,W. Washington, D.C. 20460 Subject: Application for Registration Nalco TX-I0861 Dear Mr. Brennis: AprilS, 1999

. 1GB

Nalco Chemical Companyseeks to register its product**TX~10861.** Enclosed please find the following items in supportof this application: I. 2. 3. 4. 44808201 5. 44808202 6. 7. Completed EPA Form 8570-1 Completed EPA Form 8570-4 (in Confidential Appendix) Completed EPA form 8570-27 Six copies of draftproductlabel VolumeI

- ProductChemistry infocmation VolumeII

- Analytical Method for Enforcement ConfidentialAppendix for Volume I (8570-4 and Manufacturing Procedure) 448082-00

Nalco Chemical Company wishes to request a waiver from acute toxicity data requirements (Guidelines 81- 1 through 81-6) 011 the basis that theJonnulation is essentially identical to the registeredproduct Nalco ActiPllls 2818 (Reg. No. 1706-171). The precalltionary statements on the label will be idenHcal to those for Nalco ActiPlus 2818. Also, because of the very close similarity to 1706-171, Nalco Chemical Company believes this application could qualify for "expedited review" as a "me-too" product. [fyou have any questions, please feel free to contactme directly.

Corporate Toxicologist CHW/jh



## APR 2 7 1999 

## APR 2m .ri F A roved, OM 0, 70

. 8- 5 

# I&EPA United Statee Environmental Protection Agency Washington, OC 20460

# ~ Registration Amendment 

### Other Application for Pesticide

- Section I OPP Identifier Number

# ~~f~s~ir ii, CompenyiProduct Number 1706-

### "7( .L. 

## II 

## !4, Compuny/product INumol I

## 2;,ErA**~roduct** Moneger

- / i/{flbe.A- Brennls 

## V

PM' 3, Proposed Clossificotion 

# GJ None 

# 0 Restricted TX-1G861 -5. Name and AddrulIII of Applicont (fneludfl ZIP Codfl/ Nalco Chemical Company 6. Expedited Reveiw. In accordance with FIFRA Section 31c1/3) Ib/lil, my p'oduct is similar ot identical in composition and labeling to: One Na leo Center Napervll Ie, IL 60563 EPA Reg. No. 1706-171 

# o Check if

### mfs fs • n.w eddrflSs Product Name ActlPlu5 2818 

### Section

- " 

# o Amendmenl

- Expillin bolow. 

# n \ Resubmission in rosponlll to Agency latter dated
_______ _ 

# o 

# o [2] Final printed lebol. in replonu to Agoncy lettor dated ·Me Too· Application. 

# U }Netification

- Explain below. Olher

- Exploin balow. Explanation: Use additional page{sl if necessary. IFor SlIction I and SlIclion 11.1

ApplicaTion for registratIon ot a new product, a stabilized sodium hypobromite solution. Product combines two actlve ingredients wh1=h react in situ to torm the hypobromite (sodium hypochlorite and sodium bromide).


### Section

- III 1. Material Thi. Product WlK 

### a. P.clu,g.d in: Child·Resistant Peckeging Unit Pockaging Water Solubla Packeging 2. Type of Conteiner 

# Ef" 8'" 

# 8 v.. 

## - 

# §M".
No No Plastic No Glass • r 'jifiClltion must If ·Yos· No. par If "Yell· No. por Poper Unit Packoging wgt. contoiner Packega wgl contain., Other ISpecifyl b. j;mittsd I. 3. Locetion of Net Contonte Information 4. Size{'" Retail Conleiner 5. Location of Label airections



# D 

# WContainer 15 ga I and 50 gal 

## Eg On Label Label Mini Porta-Feeds 6. Mannflr in Which label is Affixed to Product**~** Lithogrllph 

# D Other Paper r.uod Stenci itd

### Section

- IV**~ ~** **~**

# . 1. Conlact Point /Compla,e i'am.s directly below for idflntmceUon of individuel to b. conlected. ifnecossery, top,ocus this app£i;if,!ipn./ Name Claude H. Wolt, MSc. Title Corporate Toxicologist Telephone NO.llnclude AroaCodll1 630.305.1453**~.~~~~** 

### , , Certification 6. Date /,pplicatidn 

### , I cenify thai the stolaments I heve mede on this form and all attachments thereto ere true, accurete end complote.**~ec'efVed** , ••• , > 

### , , I acknowledge that eny knowfinglly felse or misleeding slelement m",y ba punlsheble by fine or impri.anment or , }fSt'i"mped) •• both**und,!!~icoble** law. >J > "." 

### , , , ••**~** > •

# 'S;g,.tU~~1- 3. TItle Corporate Toxicologist -'

- ," , , 

# .. , , 

# t _.,- ed Neme 

## (J 5. Oate '" , Claude H. Wol t, MSc. Aprl I 8 1999

-



## -- 

## -(



## ) 448082-01

VOLUME!
PRODUCT CHEMISTRY 40CFR158.190 DATA REOUIREMENT Guidelines 61-1, 61-2(a) (b), 63-2, 63-3, 63-4, 63-14, 63-15, 63-16, 63-17, 63-19, 63-20, 63-21, 7000,7100, and 7300

TESTARTICLE TX-I0861 (Sodium hypochlorite **I** Sodium bromide) AUTHOR Anthony W. Dallmier, Ph.D.

SUBMITTER Nalco Chemical Company One Nalco Center Naperville, IL 60563-1198 Date: April 8, 1999

# t9/\1~ )1

# 0

Volume I Page 1 of II 

# · , ,,>,» • 

### , ,

j.>,..**~~** 

# · " ;J'**~.,~"**



### , " • •

, j j j 

# · " , , 

### ,

, , j j 

### , ,**~**

# ..**~** 

### ,STATEMENT OFDATA CONFIDENTIALITY CLAIMS Infonnation claimed confidential on the basis ofits falling within the scope ofFIFRA section lO(d)(I)(A)(B) or (C) has been removed to a confidential appendix and is cited by cross· reference number in the body ofthe volume.

Sponsor/Submitter: 

# 0JNaiCO Chemical Camp ,Y 

# )!;;iPA. L Company Agent:**~** -' Claude H. Wolf, MSc. Date: April 8, 1999 Corporate Toxicologist

Volume I Page 2 of IIGOOD LABORATORY PRACTICES STATEMENT

NONE OF THE TESTS DESCRIBED HEREIN WERE CONDUCTED UNDER GLP PROCEDURES

Sponsor/Submitter: Company Agent: Study Director: aIco Chemical

# C1f**//L,~~** . uoe 

### H. Wolf, MSc. Date: April 8, 1999 Corporate Toxicologist Anthony W. Dallmier, Ph.D. Group Leader

Volume I Page 3 of II

### (

) VOLUME II
STUDY TITLE ANALYTICAL METHOD FOR ENFORCEMENT (40CFR158.180) DATA REOUIREMENT Guideline 62-3
TEST ARTICLE TX-1086J (Sodium Hypochlorite / Sodium Bromide)

AUTHOR Anthony W. Dallmier, Ph.D.
SUBMITTER Nalco Chemical Company One Nalco Center Naperville, Illinois 60563-1198 Date: April 8, 1999 

# ct 

# r O\s/ 

# ,<\

Volume II Page 1 of 6 448082-02



### ,

# ., , , , ,

, " , ,

, , , 

### ,
, , ,

" , • J 

# · ...**~ ~**  

### , " 

### , ,**~ ~** 

# ... , , ,

• •• , > , 

# ·

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### ) STATEMENT OFNO DATA CONFIDENTIALITY CLAIMS No claim ofconfidentiality is made for any information contained in this study on the basis ofits falling within the scope ofFIFRA § IO(d)(I)(A)(B), or (C).

Sponsor: Company Agent: Nalco Chemical Company


### Claude H. Wolf, MSc. 

### Co o,te Toxicologist 

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Volume II Page 2 of 6 Date: April 8, 1999



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# .....GOOD LABORATORY PRACTICES STATEMENT
NONE OF THE TESTS DESCRlBED HEREIN WERE CONDUCTED UNDER aLP PROCEDURES

Sponsor: Company Agent:

Study Director: 

### NaJco 

### Shemicai**comp~~L** aude

# iFw~;'~ Corporate Toxicologist

Anthony W. DaIImier, Ph.D. Group Leader Date: April 8, 1999

Date: April 8, 1999

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# ~Tlrtsis:an~**SUbmissiOn.·~) ~---~---=~~~~~----~'**  One copy ofthe PPC diagnosis and one copy ofthe annotated bibliography are

/ 

### /

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### provided for your files. The PPChas already mailed 

### out the submitter's copies ofthe two documents.

This is a PAR TlALLY ACCEPTED 

### I COMPLETELY REJECTEl**sd'~;'sioil.** 

### A 

### copy ofthe PPC dizgI10sis 

### 2D.d the: 8T1DOt2ie-j 

### bibliography are p:Q\-ije.c. for your 

### files. A 

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### provi.ceo for your 1.!....."'-e 

### in c.orresponding 

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### u.s. ENVIRONMENTAL PROTECTION AGENCY Office of Pesticide programs
NALCO CHEMICAL CO. ONE NALCO CENTER NAPERVILLE, IL 60563 Report of Analysis for Compliance with PR Notice 86-5 Thank you for your transmittal of 04/16/99. Our has completed a preliminary analysis of the material. provided as follows: staff The results

Your submittal was found to be in full compliance with the standards for submission of data contained in PR Notice 86-5. A copy of your bibliography is enclosed, annotated with Master Record ID's (MRIDs) assigned to each document submitted. Please use these numbers in all future references to these documents. Thank you for your cooperation. If you have any questions concerning this data submission, please raise them with the cognizant Product Manager, to whom the data have been released. areI ) United States E:1vironmer':JI**P~otectlon** Agenc'{ Office of PestICide Pr09rJr:".s Information Resources anc Services Division Inform.::!tion Services SrJn,;.' 

# SEPA

ADMINISTRATIVE NOeS).:

,


# PM: 3;)-**------~~-----------------------------** 

# CHEMICAL NO.:
________ _

Thejacketfor this action can be requested through theJACKETS system,

# Administrative 

# Materials

;>NEW**REG~STAT~ON** OR "NEW EUP 

# I FAST TRACK 1<**APPL~CAT~ON** FOR NEW**REG~STRAT~ON** WITH DATA NO DATA In,it. Date 

### FEU 

### if -/rk -:9;7'FEU Fileroom/JACKETS" Fileroom/JACKETS SIG (DATA) PM Fileroom/JACKETS PM 

# A(}-

REGULAR**APPL~CATION** 

### FOR NEW**APPL~CATION** OR 

### EXPERMENTAL USE PERMIT Includes new petition for Tolerance: YES or NO WITH DATA NO DATA Init. Date 

### FEU FEU Fileroom/JACKETS Fileroom/JACKETS SIG (DATA) PM'
___ _ Fileroom/JACKETS PM 

# 0'7:2.

Init. Date

Init. Date



### * Front End processing determined this application qualifies for fast track review based of registrants claim of**lIme~too".** No screen for substantial similarity is made by the Front End Processing Section.

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. , IUNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

CLAUDE H, WOLF NALCO CHEMICAL CO. ONE NALCO CENTER NAPERVILLE, IL 60563

PRODUCT NAME, TX-10861 04/21/99

COMPANY NAME, NALCO CHEMICAL CO. OPP IDENTIFICATION NUMBER: 260072 

### EPA FILE SYMBOL: 1706-RIU EPA RECEIPT DATE, 04/16/99 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

SUBJECT: RECEIPT OF APPLICATION FOR A NEW ME-TOO REGISTRATION DEAR REGISTRANT: The Office of Pesticide Programs has received your application for a new 'me-too' registration and it has passed an administrative screen for completeness. 

### During the initial screen we determined that the application appears to qualifiy for fast track review. The package will now be forwarded to the Product Manager for review to determine its acceptability for fast track status. If you have any questions, please contact Robert Brennis, Product Manager 32, at (703) -308-6346.

Sincerely,

Front End Processing Staff Information Services Branch Information Resources and Services Division

Intemat Address (URL) • http://www.apa.gov RecyclocllRocyclable. Printed wHIl Vegetable 011 Based Inks on Recycled Pap(H (Minimum 25% Pos!consumer)

# &EPA

Applicant', Name lind Addre55

Nalco Chemical Company One Nal co Center Napervllle,ll 60563-1198 Form Approved. OMB No. 207.0.0060 United States Environmen/al PrOtection Agencv Washington, DC 20460 

## Formulator's Exemption Statement 140 CFR 152.85) EPA File SVmbol/Registration Number 1706

- 

### 7(

# :z:() Product Name TX-I0861 Date of Confidential Stetement of Formulll {EPA Form 8570.4) Aprl I 8, 1999 As an authorized representative of the applicant for registration of the product identified above, Ihere certify that: (1 I This product contains the following active ingredient(sl: I) Sodium hypochlorite 2) Sodium bromide ""'!) Of these, each active ingredient listed in paragraph (41 is present soley as the result of the use of that active**"i~redient** in the manufacturing, formulation or repackaging of another product which contains that active ingredient which is registered under FIFRA Section 3, is purchased by us from another producer, and is labeled for at least each use for which my product is proposed to be labeled. (3) Indicate by checking fA) or (8) below which paragraph applies: G](A) An accurate Confidential Statement of Formula (EPA Form**8570~4J** for the above identified product is attached to this statement. That formula statement indicate, by company name, registration number, and product name, the source of the active ingredient(s) listed in paragraph (1). 

### OR 0(8) The Confidential Statement of Formula (CSF) (EPA Form**8570~4J** referenced above and on file with the EPA ',s complete, current, and accurate and contans the information required on the current CSF. (4) The following active ingredients in this product qualify for the formulator's exemption.

SOUrcB Acti"'l1 Ingredient Product Namo Regilltrlltion Number Sodium bromide Sodium hypochlorite

Namll and Title Claude H. Woll, MSc. Date Corporate Toxicologist Apri 18, 1999 White

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### Pages 97-101 *Access to FIFRA health and safety data is restricted under FIFRA section 10(g)*

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} NALCO CHEMiCAL COMPANY ONE NALCO Cf-.NTER r;: NAPERVILLE lLLlNOIS 60563-1 '88 (J AREA 630 305-1000

Mr. Robert Brennis U.S. EnvironmentalProtectionAgency AntimicrobialDivision (7510W) 410 M. StreetS.W. Washington, D.C. 20460 Subject: Application for Registration Nalco TX-I0861 Dear Mr. Brennis: AprilS, 1999

Nalco ChemicalCompany seeks to register its productTX-10861. Enclosed please find the following items in support ofthis application: 1. Completed EPA Form8570-1 2. Completed EPA Form 8570-4 (in ConfidentialAppendix) 3. Completed EPA form 8570-27 4. Six copies ofdraftproductlabel 5. Volume 1- ProductChemistryInformation 6. VolumeII

- AnalyticalMethod for Enforcement 7. Confidential Appendix for Volume I (8570-4 and ManufacturingProcedure) NaZco Chemical Company wishes to request awaiver from acute toxicitlj data requirements (GlIidelines 81- 1 through 81-6) on the basis that theJannulation is essentially identical to the registeredproductNalco ActiPlus 2818 (Reg. No. 1706-171). Theprecautionanjstatements on the labelwill be identical to thoseJar Nalco ActiPlus 2818. Also, because of the very close similarity to 1706-171, Nalco Chemical Company believes this application could qualify for "expedited review" as a "me-too" product. Ifyou have any questions, please feel free to contactme directly.

.C aude H. Wolf, MSc., CorporateToxicologist CHW/jh '" 

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### Pages 105-107 *Confidential Statement of Formula may be entitled to confidential treatment*