# EPA Reg istration No. 81293 -1 Volume No. 1

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# FEE 

# FOR SERVICE

# ~~~Ii~P~lr [!gf RiwMarmger-SerydDate: P7-p,pr-2004

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NEW APPLICA nONS

DATE: 

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FILE NUMBER:

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FEP (OPPIN ENTRY):

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TRANSMITTAL DOCUME1'<' FOR IKO INDUSTRIES LTD. 1. Name and Address of Submitter: Submitter: IKG Industries Ltd. RR #1, P.O. Box 839, 105084 Highway 7 Madoc, Ontario, 

### KOK 2KO Canada Authorized Agent: Earle Nestmann, Cantox U.S. Inc. 1011 Route 22 West, Suite 200 Bridgewater, NJ 08807 USA 2. Regulatory Action in Support orWhicb this Package is Submitted: Registration application. 3. Date of Submission: April 23, 2004 4. Application Fee: The applicant believes that fee category A54 (54,000) applies to this application for registration since the action is an application for registration ofa new antimicrobial product,**non~fast** track, for FIFRA section 2(mm) uses. S. Bibliograpby4 Volume 1:

Volume 2:

Volume 3:

Volume 4: 

### dC.,f"S Administrative Volume: Forms**(8570~1** Application x 

### t.=opy, 85704 Confidential Statement of Formula x 2 copies, 8570-27 Formulator's Exemption x 1 copy, 8570-34 Certification with Respect to Citation of Data); Draft Label 

### x 5 copies; Authorization Letter x 1 copy Product Chemistry (Guideline References 830. I 550, 830.1600, 830.1650, 830. I 670, 830.1750, 830.1800) 

## 462.5870]
Acute Toxicity Studies: Request for Waivers for AR Granules (Guideline References A \ • rcMJ,,/

... 870.1100, 870.1200, 870.1300, 870.2400, 870.2500 and 870.2600) Exposure Monitoring: Request for Waivers for AR Granules (Guideline References 

### /AJfi\AI\, 875.1700,875.1100,875.1200,875.1300, 875. 1400 and 875.1600) Company Official:

# d~\~~, Name SignalUI..! Company Name: IKO Industries Ltd. Company Contact: Earle Nestmann Tel: (908) 429·9202

# •

• DECISION PKG. NO. 

# 1'L(J. &/3
SUBMISSION BAR CODE # 

# 7 C:: 

# 7 

# 7'; 

# 'I St1lJM. DUE

# DATE~tJ/o)- REVIEWER 

# 1111 

# T CODING FORM FOR APPLICATIONS FOR**REGISTRATION!~~NDMENTS**

FILE SYMBOL/REG ND. 

# 61 d**~l-** 

# K PM 

# 3") ACTION CDDE /} 

# 5(/ , DESCRIPTOR 

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## 779-1 

# Ie 

# 1/'.<2. {**~** CHILD RESISTANT PACKAGING: 

### [ l REQUIRED NOT REQUIRED REGISTRATION TYFE: [ ] CONDITIONAL [ ] UNCONDITIONAL ] RESTRICTED USB

DATE ON APPLICATION EPA RECEIVE DATE PM RECEIVE DATE 

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METHOD OF EUFP.ORT ] CITE-ALL 1 NOT SUBMITTED 1 BELSCI'I'VE l N/A


### RBvlEW (s)**RE~STED** DATA PACK # CHEMISTRY'_.:...-

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_____ __ l [ AClJ'l'Il TO.X.

_____ _ l [ RASSB TOX.

_____ _ [ [ ENVIRON. FATE,

_____ __ l [ FISHjWILDLlFE, _____ __ l [ OTHER,

______ _ l [ 

## , FORMlJLA'I'ORS. EXEMPTION [ ] SUBMITTED [ ] NOT stlEMITTED 

## r l BfA

DATE DUE DATE SENT DATE RETtJRNED l [ lJ 

### • l [ . l [ l [ l [ l [ l [ l [ l [ l [ J[ 

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____________________________ _

RES pONSE CODE '_...L/ 

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EPA Reg. Nuu,wr. Dale**ofl"u.:m~c:** U.S.**EN\,IRO!-'~mNT;\L** PROTECTION AGENCY**$'\~t.o s.-~~'"** Office "fP"""c;<I. PrognlIl-'**~. ~** **~** Rcgistr:niOfl Dl\won (H1505C) 81293-1 

## NOV 

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# ,s.T2' 4<1l '",1' SI., S,W. i "1.;4 Washington, D.C. 2().tGO 

### • ;p**>::t~** PflO'lt." NOTICE OF PESTICIDE:**Tcmlof[:I$ua,,~:** 

### Conditional ..2L 

### Registration

_ Reregistration Name ofPcoticidc Product: (under FJFRA, as amended) AR Granules (Algae

### Resistant Roofin.g Granules) :-Jame ",,<I Alid,;;,,; of Regislr:"'1 (inclode ZW Code): IKO Industries Ltd 

# • R.R. #1, P. O. Box 839 105084 HW#7 Madoc, Ontario, Canada KOK 2KO
j";"utc: Ch.mg:s in labcllng differing in**~ub/;WlC~** from Ih.1 3tteplcd in connection ,villi tlilil**registt~!ion** muolix: submilltd to and JOC<:p!ed by Iho Rogi<lr.Ition Dl\ision prior 10 UM:**ofth~** I:obel ill commerce. In any**=~pondM"** on dlit; product :llway:;. mer [0 II!; ;bove EPA KgII;lfIOlion numl>l:T. On the I;,a.,j" ofinforrnalin" f"mished loy**~,c rcg;.tran~**  O,e**~bo""** named p<><!icide b h.roil)' rogi>lc",d/"'rcei>lcwd tmdcrthe l'eder:J[I",,,,,udde, l'n"gkidc ,,"d Rodenticide Act Regilllml;on ill in nu \ny \0**b~** Cl>lI<lnled

.. on oIndornemenl Of ",eommOf1Mlio" oflhis produCi by Ih¢ Agency, In o"""rlo prolecl ho.llh ""d**1l,~** environmcnl, Ihe Admini:strnlor, on his mol ion, may al any time

.... pm<! Of cancel the regilltr.l\jon ofa pe.ticidc in =orWmee**"i~,** Ihe Act The acceplanee of any nan", in conneclion**"i~, th~**  reW<tr.lio» of. produel under 11,;" ,\el h ,,0110!>c eOn<1rued:lS giving**~'"** reg;.'ranl. ,;ghllo excl",,,,,, USe oflluo 

### ,,3m<: orlo ils we ifil 10"" """n eo"",,,,d loy olnem. This product is conditionally registered in accordance with FIFRA sec. 3(c)(7)(A) provided that you: 

# • 1. Submit and/or cite all data required for registration! reregistration of your product under FIFRA sec. 3( c)(5) when the Agency requires all registrants of similar products to submit such data; and submit acceptable responses required for reregistration of your product under FIFRA section 4. 2. Make the following label changes:

a. Revise the EPA Registration Number to read, "EPA Reg. No.**"81293~1** ",

# ;:~~O:I~I';::~:;;~tpM 33

# CjJ~Ir/J~~ Dale: Regulatory Management Branch 1 

# NOV , 0 

## 2004 Antimicrobial Division (751 OC) I /**~**



### , EI A Fon" 8570-6

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# •

• Page 2 EPA Registration No. 81293-1

b. The Precautionary Statements must be revised to read: "Harmful 

### if Swallowed. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, or using

tobacco."

C, The First Aid statement must be revised to read: If Swallowed:

- Cal! a Poison Control Center or doctor immediately for treatment

advice,

- Have person sip a glass of water 

### if able to swallow.

Do Hot induce vomiting unless told so 

### by a Poison Contra! Center 

### or doctor. Do not give anything by mouth to an unconscious person. The basic Confidential Statement ofFonnula dated April 23, 2004 is in compliance with PR Notice 92-1, agrees with the label and is acceptable. If these conditions are not complied with, the registration 

### will be subject to cancel!ation in accordance with FIFRA sec. 6(e). Your release for shipment of the product constitutes acceptance of these conditions

. A stamped copy of the label is enclosed for your records. If you have any questions conceming this letter, please contact Martha Terry at (703) 308- 6217.

Enclosure Sincerely,

# m¥::~71~c;Y Marshall Swindell Product Manager 33 Regulatory Management Branch I Antimicrobial Division (7510C)

# •

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

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

October 5, 2004 MEMORANDUM Subject:

To:

< From:

Through:

Applicant: Acute Toxicity Review for EPA Reg. No.:**81293~R** / AR Granules DP Barcode: D308820 Marshall Swindell, PM 33 / Martha Terry Regulatory Management Branch Antimicrobials Division (7510C) Ian Blackwell, Biologist 

# LiZ-wv**IY,/}&~** Efficacy Evaluation Team ' Product Science Branch Antimicrobials Division (7510C) Karen Hicks, Team Leader Chemistry and Toxicology Team Product Science Branch Antimicrobials Division (7510C) Michele E. Wingfield, Chief Product Science Branch Antimicrobials Division (7510C)


### Cantox U.S., Inc.

FORMULATION FROM LABEL: Active Ingredient(s): Cuprous oxide other IngredientCs): Total: % by wt. 6 94 100%**L-~~** ____**~** __**~~~~~~_~~~_ ._~**  __**~~~~_~~~~_**

# •

• I BACKGROUND: PM Team 33 has submitted a request for a Similarity Clinic determination for EPA File Symbol**81293~R.** AR Granules. This submission 

### includes one 4/23/2004 (the year is undear) CSF for 81293-R. This submission also includes a basic and an alternate CSF for**73452~2,** dated 

### 1/4/01.

II RECOMMENDATIONS: PSB findings are: CIT/PSB finds that the two products are Substantially Similar. The acute toxicity profile of**73452~2** 

### may be used to determine the precautionary labeling for 81293-R. The PM Team 

### will have to address any money owed to 

### ISP Mineral Products, Inc., for this data citation. 

### The acute toxicity profile for File Symbol 81293-R is currently: Study MRID Number 

### Toxicity Status Category Acute Oral Toxicity 

### 451511-03 III Cited Acute Dermal Toxicity none 

### IV Cited Acute Inhalation Toxicity none 

### IV Cited

Primary Eye Irritation none 

### IV Cited Primary Skin Irritation 

### 451511-04 

### IV Cited Dermal Sensitization none Nonsensitizer Cited 

### I!I LABELING: 1 The Precautionary Statements should state: "Harmful if swallowed. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, or, using tobacco." 2 The First Aid statement should state: 

### If Swallowed:

• Call a Poison Control Center or doctor immediately for treatment advice. • Have person sip a glass of water if able to swallow. • Do not induce vomiting unless told to do so by a Poison Control Center or doctor. • Do not give anything by mouth to an unconscious person.

# •

• UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.c' 20460

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES September 14, 2004 MEMORANDUM 

### Subject: Acute Toxicity Review for EPA Reg. No.: 81293-R / AR Granules DP Barcode: D303517 To: Marshall Swindell, PM 33/ Martha Terry Regulatory Management Branch Antimicrobials Division (7510C) From: Ian Blackwell, Biologist

# lf217vt.-.:1~<;t1/i:.t::,A.-\

Through:

Applicant: Efficacy Evaluation Team Product Science Branch Antimicrobials Division (7510C) Karen Hicks, Team Leader Chemistry and Toxicology Team Product Science Branch Antimicrobials Division (7510C) Michele E. Wingfield, Chief Product Science Branch Antimicrobials Division (7510C) Cantox U.S., Inc. FORMULATION FROM LABEL: Active IngredientCs): Cuprous Oxide Other Ingredient(s): Total: % by wt. 6 94 100%

# •

• I BACKGROUND: Cantox U.S., Inc., has submitted a report entitled "Acute Toxicity Studies: Request for Waivers for AR Granules". This report, "Volume 3" was not assigned an MRID Number. The report states: 1 "AR Gr<'lnulp$ (",nnt<'lin an EPA-reaistered technical grade active ingredient,

I" 

### On the basis of the Formulator's Exemption, safety data for this active ingredient are not provided." 2 A waiver is requested for the acute toxicity data requirements. This request is based on the composition of AR Granules and the EPA regulatory status of the components. Material Safety Data Sheets (MSDS) are provided in the reference section, including the MSDS for AR Granules

. 3 Waivers are requested for each of the six 870 series acute toxicity and primary irritation studies. Page 12 of the report states: "Waivers are requested for the acute toxicity data requirements for AR Granules based on the composition, the granular form of the product, the pattern of use, and available acute toxicity data on the components. Furthermore, similar copper granule products have been marketed in the United States (e.g., EPA Reg. Nos. 10350-63 and 73452-2) and the safety profile of AR Granules is not expected to differ from that of these products, based on their similar chemical composition, granular form, and similar intended patterns of use."

II RECOMMENDATIONS: PSB findings are: 1 The waivers are denied. The registrants might want to familiarize themselves with several parts of the 40 CFR as an aid to understanding acute toxicity studies and the waivers of these studies: A §158.45, b, (1): An applicant should discuss his plans to request a waiver with the EPA Product Manager responsible for his product before developing and submitting extensive support information fpr the req uest. It is apparent to CTT 

### IPSBI AD that the registrant put a lot of effort in to his waiver request. We do not like having to reject waiver requests, especially when they are so detailed. A discussion with the PM might have averted the registrant having submitted this much Information without it being useable.

# •

• B §158.75 b: "". In addition to or in lieu of the testing required in subparts C and 0 

### of this part the Administrator 

### will, on a case-by-case basis, require testing to be conducted with: 

### (7): The end-use pesticide product. (8): The end-use pesticide product plus any recommended vehicles and adjuvants. Registrants are expected to conduct acute toxicity studies on end-use 

### products when they exist (as opposed to technical products). C §158.340 (a) Table: A complete explanation of this table and the relevant parts is not feasible in this review; however, the main acute 

### toxicity walver criteria are: (1) The material is a gas or highly volatile. (This does not apply to 81293-R.) (2) The test material is corrosive to skin or has a pH less than 2 or 

### greater than 11.5. (This does not apply to 8293-R.) (3) Acute Inhalation Toxicity: Required 

### if the product consists of, or under conditions of use 

### will result in, an inhalable material. The registrant may able to demonstrate that this is the case for 

### 81293-R. In order to do so, they 

### will have to have an attrition 

### study conducted, and/or, have a lab attempt to grind the material to develop inhalable material. 2 The registrant has provided a list of ingredients found in this product and provided some acute toxicity and irritation information on these products. Many registrants do this, but, it is not acceptable. CTT/PSB/AD is concerned with **synergy,** 

### that is, interactions that are known to happen between various chemicals
. 3 These criteria are those that all products must comply with. The registrants of the cited products (EPA Reg. Nos. 10350-63 and 73452-2) had to comply with these standards also. The only alternatives are if a product is classified "Substantially Similar" to another product. In these instances, the registrant will 

### cite or suggest a particular product (it is up to the registrant to determine the product) that they feel has a formulation identical to, or, highly similar to their registration product. This cited product will contain **each** 

### of the active ingredients and all of the other ingredients listed in significant quantities. 4 Concerning the formulator's exemption, the registrant may not have to conduct acute toxicity studies on the technical, but the formulator's exemption does not apply to the end-use product.

### •

The acute toxicity profile for File Symbol 81293-R is currently: Study MRID Number Toxicity Status 

### Category Acute Oral Toxicity none Data requested Acute Dermal Toxicity none Data requested 

### Acute Inhalation Toxicity none Data requested

Primary Eye Irritation none Data requested Primary Skin Irritation none 

### Data requested

Dermal Sensitization none Data requested 

# • III LABELING: No precautionary labeling can be recommended at this time
.


# •

# • •


# • • --------------------- I _



## IKO INDUSTRIES LTD.
AR GRANULES (ALGAE-RESISTANT ROOFING GRANULES) FOR CONTROL OF ALGAE IN ROOFING SHINGLES ACTIVE INGREDIENT: CUPROUS OXIDE •.•.•...... 6% INERT INGREDIENTS ................................•...•.... 94% TOTAL

....................... IOO.O%

CAUTION EPA Reg. No. EPA Est. No. Net Contents: (lbs)

KEEP OUT OF REACH OF CHILDREN DIRECTIONS FOR USE 

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### It is a violation of Federal Law to use this product in a manner inconsistent with its labeling. If granules are to be stored prior to and during use, a copy of this label must be readily accessible to employees when they are in their work area. 

### For use in the manufacture of roofing shingles. AR Granules should be mixed with standard roofing granules at a rate of2-1 0% by weight and processed normally during manufacture of the 

### shingles. For applications where algae growth is severe, unifonnly blend with standard roofing granules at a rate not to exceed 20% by 

### weight.

STORAGE AND DISPOSAL
Do not contaminate water, food, or feed by storage or disposal. Pesticide Storage: Store under ambient conditions. ACCEPTED with COMMENTS in EPA Letter Dalcd: NOV 1 2 ZllO{ Under the Federal Insecticide, Fungicide, and Rodenticide Act 113 amended, for the pesticide, registered under EPA Reg. No.



### ;?/,L 

## 70'- (
Pesticide Disposal: Wastes resulting from the use of this product may be disposed of on site or at an approved waste disposal facility. Container Disposal: Railcars and trucks**~** completely empty container into application equipment and thoroughly clean prior to refilling. Papcr and plastic bags

# • •


# • • ..

- completely empty bag into application equipment. Do not reuse bag. Dispose of empty bag in a sanitary landfill, or by incineration, or 

### if allowed by state and local authorities, by burning. Ifbumcd, stay out of 

### smoke.

Manufactured 

### by IKO Industries Ltd. R.R.# I, P.O. Box 839 105084 HW#7 Madoc, Ontario, Canada 

### KOK 2KO

ACCEP'I'ElJ

, with COMMENTS In EPA Letter D:;t0d: hlOV 1 2 (OrA**!Jr,d~r** ,the federal lncocticide**Fung::Cld~.** Wld Rodenticide**}l.~** as**~~nded.** for ti',e pesticide, lelJlSlered under EPA Reg. No.

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......... 

# _-----------------DP #: (303517) 

### DATA PACKAGE BEAN SHEET Date:**01..Jun~2004** Page tot 2 

### * * * Registration Information 

### * * * Registration: 61293-R -AR**G~NULES** (ALGAE-RESISTANT**ROOFIN~_GRANULES)** _

Company: 6t293
-**CANTq~i!..S.,** INC. Risk Manager: RM 33
- Marshall Swindell- (l03) 308--634t Room# CM-2 30SH Risk Manager Reviewer:**Ma~ha** Te.ny**~~~~'!** 

### _______**~.~** Sent Date: 27-Apr-2004 Calculated Due Date: t3·Nov-2004 Type of Registration:**Pr~uct** Registration - Section 3 Action Desc: (A54) NEW PRODUCT;NON-FAST -r:RACK;FIFRA SEC. 2(MM} USES;

Ingredients:**02~Ot,** Cuprous**0~ide(6.,%~)** __ _ 

# • * * * Data Package Information 

### * * *
Date Sen!: 0 t-.lun-2004 DP Ingredient: 02560 t,**Cuprous~'~'~;d~.** __ _ Decision #: 342613

Edited Due Date:

Due Back:

CSF Incillded: • Yes ) No Label Included: • Yes ,-:-, No Parent OP #:

___ _
Oate In Orgar.iution: AO I PSB _____ _

Contractor Name: 

### * * * Studies Sent for Review 

### * * * No Studies 

## I:> Administrative Due Date:**~Nov-2004 ~** **~~** Negotiated Due Date: Projected Completion Date: 

# 1.¢4f"Y 

# i!oLijd

* * * Additional Data Package for this Decision 

### * * * Printed on Page 2 

### * * 

### * Data Package Instructions 

### * * * Please review Ihe acute toxicity data package (Volume 3) request for waivers to support the new registration, along with the label and new CSF.

FQPA ACTION CODE A57 S# 759097 SC DUE tOft3l04 ADMIN DUE t t1t3/04DP#: (303513) 

### DATA PACKAGE BEAN SHEET Date: 01..Jun·2004 Page 1 of 1 

### '" '" '" Registration Information'" '" '" Registration: 81293-R
-**A~~.GRANULES** (ALGAE-RESISTANT ROOFING**G~NUL_~** __ _ Company: 81293
- CANTOX U.S., INC. Risk Manager. RM 33
-**Mars~1I** Swin_dell- (703) 308-6341**~oo~_~M-2 308~.,**  .. _ ... Risk Manager Reviewer:**f!larth~~,Iell}',~E_~.RY "'~~**  _______ ... __**._~** ___**~** _____ _ Calculated Due Dale: t3·Noy-2004 Type of Registration:**Produ_~t Re!i~tratio~**  -**Sectio~** Action Desc:**(A54~~_~RQ[~UCTi~ON-F_"'-ST T~CK;FI~_~** **SE~. 2(M_~)** **USE~** _____ _ Ingredients:**Q.~_!i601, ~UP!£l!.~5)!idet~~_**  ____ ___**~** __ , __ _ 

# • '" '" '" Data Package Information'" ,., '" Expedite:**,'_~,'** Yes. No Date Senl: 01-Jun·2004 DP Ingredient: 025601, Cuprous oxide

CSF Included: • Yes " No Label Included: • Yes No Paren1 DP#:

Date In Date Out DeCision #: 342613

Edited Due Date:

Due Back:

Organization:**~O** {**p~_** .. Team Name: CTT Adminislralive Due Dale: t3-Noy-2004



# --- --$-/- _iewer Name:

## jtZ~1]Ih 

# ____**~J2,"1** 

# ___ _ Contractor Name: 

### '" '" '" Studies Sent for Review'" '" 

### * No Studies Negotiated Due Dale:

### L¥S~f Projected Completion Date:**5~¥-~_~**



### '" ,., '" Additional Data Package for this Decision'" '" '" No Additional Data Packages



### ,., '" ,., Data Package Instructions'" '" '" Please review1he product chemistry data package (MRID # 462587·01) along with the label and CSF in support of the new registration.
FQPA ACTION CODE A57 S# 759097 SC DUE 10f13f04 ADMIN DUE 11ft3f04**--------------------~----**



### ,

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANces Antimicrobials Division


### July 29, 2004 SUBJECT: PRODUCT CHEMISTRY REVIEW OF: AR Granules (Algae-Resistant Roofing Granules) 

# •

TO:



### FROM:

THRV: 

### DP Barcode: D303513 Manufacturing-usc [ ] OR Reg. No. Or File Symbol: 81293-R End-use Product [X] Marshall Swindell PM 

### 331 Martha Terry, Team Reviewer Regulatory Management Branch II Antimicrobials Division (751 OC) 

### Robert A. 

### Turpin, Chemist 

# --7\ 

# --r Product Science Branch, CT 

### Team ' Antimicrobials Division (75IOC) /

. ),' 

### Karen P. 

### Hicks, CT Team Leader /' 

# j**~** 

# ) Product Science Branch / 

# V L _

## ~
Michele E. Wingfield, Chief Product Science Branch 

### Antimicrobials Division (7510C) 

### Product Formu1ation 

# . ? 

# f5 0

Active Ingrcdient(s) % by 

### wt. Cuprous oxide

..................................................... 6.0

BACKGROUND: The applicant has submitted an application for registration of its product, AR Granules (Algae-Resistant Roofing Granules). 

### In support of the application, the applicant has submitted a Confidential Statement of Fonnula (CSF), a draft product label, and product chemistry data responding 10 

### the requirements ofOPPTS Test Guidelines, Series 830, Group A.



### Page I of 6

### FINDINGS:



# • 1. The CSF of the subject product is not acceptable. The formulation contains an inert ingredient that has not been approved for usc in pesticide products. The inert material, is further described 

### by a generic chemical name, 2. The product label does not list in the Active Ingredient section the metallic copper equivalent 

### content. 3. MRID #462587-01: The report contains 

### data responding to the requirements ofOPPTS Test Guidelines, Series 830, Group A. 

### The data responding to the requirements of 830.1550 are 

### acceptable. The data responding to the requirements 0[830.1600 are acceptable. The data responding to the requirements of 830.1650 are acceptable. The data responding to the requirements of 

### 830. 1670 are acceptable. The data responding to the requirements of 

### 1750 are acceptable, The data responding to the requirements of 

### 830.1800 are acceptable. 4. 

### The applicant did not submit data responding to the requirements ofOPPTS Test Guidelines. Series 

### 830, Group 

### B, physical and chemical characteristics of the product.



### RECOMMENDATIONS: 1. The applicant must submit to the Agency a full disclosure of the inert material, that includes the chemical name of the and the percentage of composition of each component in the composition. If the information is proprietary to the manufacturer/supplier, the supplier may sent the formulation data directly to the Product Manager. In addition to the identity of each component by chemical name, each should be identified by CAS Reg.#. Please 

# e advise the supplier to send the confidential disclosure via express delivery, e.g., FedEx or UPS. 2. 

### The applicant must revise the product label to include the Metallic copper equivalent statement of content. 

### 3. The applicant must address the requirements of OPPTS Test Guidelines, Series 

### 830, Group B, physical and chemical properties of the product.

Page 

### 2 of 6

### PRODUCT CHEMISTRY REVIEW 4. CONFIDENTIAL STATEMENT OF FORMULA 4a. Type of formulation 

### and source registration



### • Nonwintegrated formulation system 

## [X] • Are all TGAIs used registered? Yes [X] 

### No [ ]

• Integrated formulation system [ ]



### • if "ME- 

### TOO", specify EPA Reg. 

### # of existing product: 4b. Clearancc of inerts for non-food or food use: 

### • Cleared for food use under 40 CFR §I80.1001: Yes [ ] No [ ] NA [X]



# • 4c. Physical state of product: Solid 4d. The chemical IDs and analytical information (including**tha~** 

### for the TGAIs), density, pH, and flammability are consistent with that given in 830, Part B 

### Yes[] No [X]* 

## * No data submitted. 

### 4h. NCs and CLs are acceptable: Yes [X] No [] Not acceptable [ ] 4i. Active ingredient (s) 

### NC LCL UCL Cuprous oxide 6.13% 5.82% 6.44% 

### 4j. For products produced 

### by an integrated formulation system:



### • All impurities oftoxicoJogicaJ significance 

### have a UeL? 

### Yes [ ] No [] Not applicable [X]



### • All 

### impurities of 2: O. I % in 

### the product have been identified? Yes [] No [] Not applicable [X]

Page 3 of 6

### 5. PRODUCT LABEL



# •

• Sa. The active ingredients statement (chemical IDs and NC] is consistent with the CONFIDENTIAL STATEMENT OF FORMULA? Yes 

### [X] No [ ] 5b. The fonnulation contains one of the following:



### • 10% or more of a petroleum distillate: Yes [ 

### ] No 

### [X] 

### • 1.0% 

### or more of methyl alcohol: 

### Yes [ 

## 1 No 

### [X] • Sodium nitrite at any level: Yes [ 

## 1 No 

### [X] 

### • a toxic List 1 inert at any level: Yes [ 

### ] No 

### [Xl 

### • arsenic in any [ann: Yes [ 

### ] No 

### [X]
5c. If Yes to any of the above, does the inert ingredients statement contain a footnote indicating this? Yes [ 

## 1 No [ ] Not applicable 

### [X] Sd. The appropriate warning statement regarding flammability or explosive characteristics of the product are listed on the label? 

### Yes [ ] No [ ] Not applicable 

### [X] Se. The storage and disposal instructions for the pesticide and container arc 

### in compliance with PR Notice 84·1 for household use products or PR Notice 83-3 [or 

### all other uses? Yes [Xl No (] Not on label 

### Sf. Does the product require an expiration date at which time the NC falls below the LCL (based on the one year storage stability data or other information)? Yes[] No 

### [X]

Page 4 of 6

### Guideline

# ~~ Acceptance of MRIDNo.
830.1550 1 

### Product A 462587-01 830.1600 Description of Materials 

### A 462587-01 

### 830.1620 Production Method 2 

### NA 830.1650 Fonnulation process 3 

### A 462587-01 

### 830.1670 Formation ofimpurities 4 

### A 462587-01**~700** 

### Preliminary Analysis' 

### NA 750 Certified Limits 6 

### A 462587-01 1830.1800 

### Method 7 

### A 462587-01 

### Explanation: A=acceptabJe; N=not acceptable; NA=technically not applicable; G=data gap; U=requires upgrading; W=waived; E=EPA estimate. 

# • ISee Confidential Appendix A for additional infonnation lFor MP/EP products produced by 

### an integrated fonnulation system. ]For products from a TGAI or MP. 4May be waived unless actuaUpossible impurities are of toxicological concern . 5Five batch analysis required for products produced by an integrated formulation system. {lIf different from standard CIs recommended in 40 CFR 158.175, this should be discussed in Confidential Appendix A. 

### TAbbreviate method used as follows: gas chromatography (GC), infrared (lR), ultraviolet absorption (UV), nuclear magnetic resonance (NMR), etc.

Page 5 of 6

### 6b. PhYsical/Chemical

# ~ Value 

## u. '"litative MRlDNo.

## ~ 830.6302 Color G 830.6303 Physical state G 830.6303 Odor G 830.7200 Melting point NA 830.7220 G 

# ,"
830.7000 pH' NA

# ~()::I14 OxidationlReduction G 830.6315 ;1 ;f' 

### G 830.6317 Storage stability G 830.7100 NA 830.6319 Miscibility2 NA 830.6320 Corrosion Character. G 830.6321 N;\ Explanation: A=acceptable; N=not acceptable; NA=technicaJiy not applicable; G=data gap; eU=reqUircs upgrading; W=waived; E=EPA estimate.

>\< 

### Provide brief description, e.g.,**color~-yeJlow** 

### or property value, e.g., density 1.25 glee;

Unless otherwise indicated, the property should be at 25 

## [)c.

1 

### If product is dispersible with water

2 

### If product is an emulsifiable liquid

Page 6 of 6DP #: (308764) 

### DATA PACKAGE BEAN SHEET Date:**29~Sep~2004** Page t of2

1< 1< 1< 

### Registration Information 1< 1< 1< Registration:**~~?~_3-_f3.** - AR __**~~~_~_~~SJ.~!:..G~~~ES~S~Ar~~T RODF~~G** **~~~~LES)** Company:**8!~9~_-~A~TQXy:~.,_!.N_!::.:..,"** ____**~** __________**~** ______**~** _____ _ Risk Manager:**~/VI ~_~:.** **",!~~~al_~S~~n~~II_-J~231~~~~~R.~o:l'!l_#gM~_2_** 3E_8J:1_ Risk Manager Reviewer:**t.AaE_h~_ T~ny** **M.T~f~.R~** _____ _ Sent Date: Calculated Due Date: 20·Mar-2005 Type ot Registration:**~r~uE! Re~!!!r!~()!'_-~_~().!'_L**  Aclion Desc:**(i\~4LN~.£'139~~!::_!:~O~f~SI_ TRACKf~F!0** **J>~~·_3(~~t~S_~S~** ____ _ 

# • 1< 1< 1< 

### Data Package Information 1< 1< 1< Expedite: Yes. No DP Ingredient 025601, Cuprous oxide

CSF Included: • Yes

Organizalion:**~D!. P_~B**  Team Name: CTT No Label Included: • Yes

Dale In No Parent DP #:

Da1e Dut Decision #: 342613

Edited Due Date:

Due Back:

Administrative Due ate: Negoliated Due Dale: 

# .'W" N,m,_-By;)Q'r

_ Prolected Completion Date Contraclor Name: 

### * 1< 1< 

### Studies Sent for Review 1< 1< 1< No Studies

1< 1< 1< 

### Additional Data Package for this Decision 1< 

### * 1< 

### ,/10.,$ 

# /3

< • , 1< 1< 1< 

### Data Package Instructions 1< 1<

### 1<~_--_;f~ ""- TOeOeTURP'N 

# IP 

# #/1,0

< THIS IS A FEE Fo.R SERVICE RESUBMISSIONAND THE ACTUAL TURNARDUND I E IS 10/t3/04 FOR SCIENCE 

# .A;; / J - ,: IV

-- 

# urp
PLEASE REVIEW THE COMPANY'S FAXED CHEMISTRY INFORMATION FRo.M THE PRo.DUCT C EVIEW (Co.PY 

# "-t' C ATTACHED) THAT EPA SENT THEM. THE FAXED CHEMISTRY INFo.RMATION IS ALSO. BASED o.N THE AGENCY'S LETTER DATED**~** 

# :f9/2/04 (COpy ATTACHED)_ A COPY OF THE CSF**A~~~~~ATTACHED. ~~~_**  FQPA ACTIONCDDEA54 S# 767914/-SC DUE 10f1¥05/ ADMIN DUE 11/t3f 05 

# crOCk

,**~** 

## ,**'----~** Prlnled on Page 2

### SUBJECT: 

# • UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Antimicrobials Division



### October 19,2004 PRODUCT CHEMISTRY REVIEW OF: AR Granules (Algae-Resistant Roofing Granules) DP Barcode: D308764 Manufacturing-use [ 

## I OR Reg. No. Or File Symbol: 81293-R End-use Product [Xj TO: Marshall Swindell PM 

### 331 Martha Terry, Team Reviewer 

### Regulatory Management Branch II

FROM:

THRU: 

# •
THRU: 

### Antimicrobials Division (751 DC) 

### Robert Turpin, Chemist 

# k _**~** Product Science Branch, C1 Team Antimicrobials Division (75lOC) Karen P. Hicks, CT Team Leader Product Science Branch Antimicrobials Division (751 OC) Michele E. Wingfield, Chief Product Science Branch Antimicrobials Division (7510C) 

### Product Formulation Active Ingredient(s) 

### % by 

### wt. Cuprous oxide

.................. ,........................................ .... 6.0 BACKGROUND: The applicant has submitted a response to the Agency Fax of September 2, 2004, in which the Agency requested the identity of an inert ingredient, a revised product label and responses to product physical/chemical data gaps.


### Page I of 3

## ,



# • FINDINGS: 1. 

### MRlD #462181-01: The report contains a description of the method employed to clarify the subject product and determine the glutaraldehyde content. The method is acceptable, 

### 2. 3. 

### 4. 5. 

### 6 . 7. The Active Ingredient section of the product label is acceptable. The applicant requests a waiver of the requirement of830.6314. The waiver is granted. The applicant requests a waiver of the requirement of 830.6315. The waiver is granted. The applicant requests a waiver of the requirement of 830.6317. The waiver is granted. The applicant requests a waiver of the requirement of 830.6320. The waiver is granted. The data responding to the requirements 0[830.6302, -6303, -6304, and -7220 are acceptable.

RECOMMENDATIONS: None

. 

# •

Page 2 of 3

# r

6b. Acceptance Value or qualitative MRIDNo. of data 830.6302 Color A Shades of black, gray or Letter dated brown 

### 9117/2004 830.6303 Physical state A Solid 

### " 830.6303 Odor A 

### oily 

### " 830.7200 "",

.... g point NA 830.7220 DCllsitylRelative A 96-100 Ibs/H) ; Sp. Gr**~** 

### " densitylbulk density 2.60-2.72 830.7000 pH' NA 

### 830.63140xidationIReduction W 830.6315 W 830.6317 stability W 830.7100 , NA 830.6319 Miscibility! NA 830.6320 Corrosion Character. W 830.6321 Dielectric breakdown NA

_ Explanation: A=acceptable; N=not acceptable; NA=technically not applicable; G=data gap; U=requircs upgrading; W=waived; E=EPA estimate. 

## * Provide brief description, c.g., color--yellow or property value, e.g., density 1.25 glee;

Unless otherwise indicated, the property should be at 25°C.

I ffproduct is dispersible with water

2 If product is an emulsifiable liquid

Page 3 of 3DP #: (308820) Decision #: 342613 

### DATA PACKAGE BEAN SHEET Date: 30·Sep-2004 Page 1 of 2 

### * * * 

### Registration Information * * * Registration:**812_9.~:_~** - AR**G_~~~_LE~_!.o.~~AE-RESISTANT R~O~_'Ng**  __**g~U~_S}** Company: 81293· CANTOX U.S., INC. Risk Manager:**R~** 33 --=**Mars~~~~ill_~_~!!_:yo~!'!9_~:§_~~1** Ro_()m#**g~-2** 308H Risk Manager Reviewer:**~al!ha _!_t:;~** **MT~_I3.~~** ___ _ Sen1 Date:**2!::Apr-:~904** Calculated Due Date: 13-Nov·2004 Type of Registration:**prod_'!.~_R~gistr~().n** -**Sec~()_~** __**~** Action Oesc:**(~S.~LNEW PRODUCT~~ON-FAST_TRI\g!S.~lfRA** **S_~~.** 2(M_MLUSES:

Ingredients:**02~601_, Cupro_~_s**  oxide(6%) 

# • * * * Data Package Information 

### * * 

## * Expedite: Yes. No Date Sent:**3Q.Sep~2004** DP Ingredienl:**0256~_~~** Cuprous oxide

DP Tille: Clarification on Acute Tox Review Due Back:

CSF Included; Yes. No Label Included: Yes. No Parent OP #:

Organization: 

### ",E!**PS~_** Team Name; CIT .viewer Name:

### ~traclor Name: Date In Date Out



### * 

### * * Studies Sent for Review 

### * 

### * "" No Studies Administrative Due Date: 13-0ct-2004 Ne90tiated Due Date: 

### /.0 

# #:-£'**~** 

## y Projected Completion Dale:**7./0!;_7/~_Y**



### * * "" 

### Additional Data Package for this Decision * 

### * * Printed on Page 2 * 

### * * 

### Data Package Instructions"" "" "" TO tAN, WOULD YOU PLEASE REVtEWTHE TOX PACKA.GES FOR BOTH PRODUCTS (EPA FtLE SYMBOL 81293-RAND EPA REGISTRATION NO. 73452-2) AND DETERMINE IOF THE WAIVER WHICH WAS GRANTED FOR EPA REGISTRATION NO. 73452·2 CAN APPLY TO THE PENDING APPLICATION (EPA FILE SYMBOL NO. 81293-R. A PRELIMINARY REVIEW OF BOTH CSFS SEEMS TO INDICATE THAT BOTH PRODUCTS ARE SUBSTANTIALLY SIMILAR IN FORMULATION. \

FQPA A. CODEA57 S#7590 7 SC DUE 10113/04 DMtN DUE 11113/04 

# to 

# 1

# •



# • .. _- 

## _ .. -_ .. 

# _---

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



### July 8, 2004 MEMORANDUM OFFICE Of pREVENTION, PESTlCIDES AND TOXIC SUBSTANCES



### SUBJECT: Risk Assessment and Science Support Branch's Response RE: Human Exposure Waiver Requests for AR Granules (Algae-Resistant Roofing Granules) (ID No 

### 81293-R) FROM: NonnCook,Chief

# ~ 

# Gut. f/f/o4-- Risk Assessment and Science Support Branch Antimicrobials Division (7510C) TO: Marshaii Swindell, Product Manager 33 

### Regulatory Management Branch II (RMB-I) Antimicrobials Division (7510C) 

### CHEMICAL: Cuprous Oxide PC CODE: 025601 BARCODE: D303518

The Risk Assessment and Science Support Branch (RASSB) bas received several human expo9Bre waiver requests related to an application for AR Granules (Algae-Resistant Roofing Granules), IDNo **81293HR.** 

### These waiver requests concern the following data requirements: 875.1100/875.1600

- 

### Dermal Exposure Outdoor 875.1200/875.1600

- 

### Dennal Exposure Indoor 875.13001875.1600

- 

### Inhalation Exposure Outdoor 875.1400/875.1600

- 

### Inhalation Exposure Indoor

# •



# • Note that RASSB has not reviewed these waiver requests because it is our understanding from discussions with the Product Manager, Marshall Swindell, that the use pattern being considered is 

### already registered for this chemical. Considering this, RASSB is merely filing the waiver requests since there is no need to review them for a registered use pattern. If there are any questions, please contact Norm Cook of RASSB.



### 2

### , DP #: (303518) 

### DATA PACKAGE BEAN SHEET Date:**08..Jul~2004** Page 1 012 

### * 

### * * Registration Information 

### * * '* Registration:**~~9S.~--=---~~** GRANULES3ALGAE-!'lESI.?TA!'!T**ROOFINGGRA,~.!:!.~ES)** __ _ Company:**~1293** - CANTO?,**U:~:!~~** ________ 

# m_____ __ ___ _ ___ "

_____ ,, __ Risk Manager: AM**_?_~~_~_~hall_~y.tind.!:~ (70?t?~_S.·6341** **£l!?_O~ ~~2_!!O_~H_**  _ __ _ Risk Manager Reviewer:**~arth~2.~~ ~TEf3RY**  ___**~_** , _________________________________ _ Sent Date: 27-Apr-?p04

__ _ Calculated Due Date: 13-Nov-2004 Type of Registration: P!'?duct**_Reg~~tn:l:!jon** -**Se~~on~_** Decision #: 342613

Edited Due Date:

Action Desc:**(~)** N.!=W**~.RODUCT;NON.FASTTRACK;~fFRA_** SEC.**2(~LUS~~_.** __ . 

# • * * * Data Package Information 

## '* * 

## '* Expedite: eYes • No. Dille Sent: 01·Jun·2004 Due Back: DP Ingredient:**?2~60!~uprous ox~~**  __ _

CSF Included: • Yes 

### 0 No Label Included: • Yes 

### 0 No Parent DP It:

Da1e In Date Out 18·Jun·2004 08.Jul·2004 Administrative Due Date: 28·Nov·2004 Team Name: RASSB2 t8-Jun'2004 08.Jul·2004 Negotiated Due Date: t8.Jun-2004 08-Jul·2004 Projecled Compel ion Date: Contractor Name: 

### * 

## * * Studies Sent for Review 

## * * * No Studies 

### * * 

### * Additional Data Package for this Decision 

### * * * Printed on Page 2 

### * * * Data Package Instructions 

### * * * Please review the exposure monitoring data (Volume 4) request 10r waivers for the support of Ihe new registration.

FQPA ACTION CODE A57 $#759097 SC OUE 10/13/04 ADMIN DUE 1 t/13/04303513 303517 303517



# •

• AD I PSB ADfRMB1 AD/PSB Page 2

01·Jun·2004 01·Jun·2004 13-Oct·2004 01..Jun·2004 13-Oc1·2004

# •



# • TRANSMlITAL DOCUMENT FOR IKO INDUSTRIES LTD. 1. Name aDd Address of Submitter: Submitter: lKO Industries Ltd. RR #1, P.O. Box 839, 105084 Highway 7 Madoc, Ontario, 

### KOK 2KO Canada Authorized Agent: Earle Nestmann, Cantox U.S. Inc. 1011 Route 22 West, Suite 200 Bridgewater, NJ 08807 USA 2. Regulatory Action in Support of Which this Package is Submitted: Registration application. 3. Date of Submission: April 23, 2004 

### 4. Application Fee: The applicant believes that fee category A54 (S4,000) applies to this application for registration since the action is an application for registration of a new antimicrobial product,**non~fast** track, for FIFRA section 2(mro) uses. 5. Bibliography: Volume 1:

Volume 2:

Volume 3: ;;; Cof\tS Administrative Volume: Forms (8570-1 Application x t-copy, 8570-4 Confidential Statement of Formula x 2 copies, 8570·27 Formulator's Exemption x I copy, 8570-34 Certification with Respect to Citation of Data); Draft Label x 5 copies; Authorization Letter x 1 copy Product Chemistry (Guideline References 830.1550, 830.1600, 830.1650, 830.1670, 830.1750.830.1800) 

### 462.5870)
Acute Toxicity Studies: Request for Waivers for AR Granules (Guideline References /I \ • I'VJ/M". 870.1100. 870.1200. 870.1300. 870.2400. 870.2500 and 870.2600) Volume 4: Exposure Monitoring: Request for Waivers for AR Granules (Guideline References 

## AJtAi..I\.. 875.1700. 875.1100. 875.1200. 875.1300. 875.1400 and 875.1600) Company Official: 

# fQ-.<k 

# Nt

# '-\-"'''~~ 

# d:**\(~cL&~,** Name Signalt...f.! Company Name: IKO Industries Ltd. Company Contact: Earle Nestmann Tel: (908) 429-9202

## . 

# ,



# ,

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

CANTOX U.S, INC 10111 ROUTE 22 WEST, SUITE 200 BRIDGEWATER, NJ 08807- April 30. 2004

Report of Analysis for Compliance with PR 7'Jotice 86-5 OFFICL or 1'll.I'VE:>:TIO"_I'IXrI('ll)E); .\;\1) fO:-:IC S]'BST,\;\CFS

Thank you for your submittal of26-APR-04,. Our stalThas completed a preliminary 

### analysis of the material. The results are provided as [ol1(1\1o.'s:
Your submittal was found to be in full compliance with the standards for submission 

# or data contained in PR Notice 86-5. A copy of your bibliography is enclosed. annotated with Master Record 10's (MIUDs) assigned to each document submitted. Please use these numbers in all future references to these documents. Thank you for your cooperatiol1. 

### Ifyml have any questions concerning this data submission, please raise them with the cognizant Product Malinger, to whom the data have heen released.

### ,~~'I~JNe~**~egistrotion**

# ':;"»ff~;t~1,,~,3ii'**:pA~;~X:;U:S;!,tJC:**

# ~~,~~~,I:Ji~~~~s,~;~,:"~s,k:Man,;~,T~,,~3>,,, 

# " ""**':<~] ,";'Pri;'cli~~a~':Jn~'~7R** **'Pi~ Na~':'** **tR'GR~LEs** (AlG.t:e-RESISTANT,ROOfJN: 

# 046"''''# I

FS-Apr-2004



# , Prinlletter, 

# I
Enter**Mor~** lnfOflmllion

## • •



# ,

, TRANSMITTAL DOCUMENT FOR IKO INDUSTRIES LTD. 1. Name and Address of Submitter: Submitter: IKO Industries Ltd. RR#l. P.O. Box 839.105084 Highway 7 Madoc, Ontario, 

### KOK 2KO Canada Authorized Agent: Earle Nestmann, Cantox U.S. Inc. 1011 Route 22 West, Suite 200 Bridgewater, NJ 08807 

### USA 2. Regulatory Action in Support of Which this Package is Submitted: 

### Registration application. 3. Date of Submission: April 23, 2004 4. Application Fee: The applicant believes that fee category A54 ($4,000) applies to this application for registration since the action is an application for registration ofa new antimicrobial product, non-fast track, for FIFRA section 2(mm) uses. 5. Bibliography: Volume 1:

Volume 2: ;) C<>f\t!S Administrative Volume: Fanns (8570·} Application x t-eopy, 8570-4 Confidential Statement of Fonnula x 2 copies, 8570-27 Fonnulator's Exemption x 1 copy, 8570-34 Certification with Respect to Citation of Data); Draft Label x 5 copies; Authorization Letter x 1 copy Product Chemistry (Guideline References 830.1550, 830.1600, 830.1650, 830.1670, 830.1750.830.1800) 

### 4 6 2S!170] Volume 3: Acute Toxicity Studies: Request for Waivers for AR Granules (Guideline References 870.1100. 870.1200. 870.1300, 870.2400. 870.2500 and 870.2600) 

# lid",

. ...;

Volume 4: Exposure Monitoring: Request for Waivers for AR Granules (Guideline References 

# R d f() :.,J 875.1700. 875.11 00. 875.1200. 875.1300. 875.1400 and 875.1600) Company Official: 

# fc-.<"\e.

# N,'+""",,~**d:\G]j\~,** Name Signalt..r.! Company Name: IKO Industries Ltd. Company Contact: Earle Nestmann Tel: (908) 429-9202

### Pages 37 through 45 contain FIFRA Registration Data and are not included in this copy.

# I**--~~ ~----------**  ---
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### April 28, 2004

PLEASE**RETU~'i .~\**  

### COPY OF THIS LETTER WITH PAYMENT opp 

### Decision Number:**D~342613** 

### EPA File Symbol or Registration Number: 81293-R OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Product Name: AR GRANULES (ALGAE-RESISTANT ROOFING GRANULES) EPA Receipt Date: 26-Apr-2004 

### EPA Company Number: 81293 Company Name: CA!'-!TOX U.S

.. INC. EARLE NESTMA,-" CANTOX U.S.,I'iC. 10111 ROUTE 22 

### WEST, SUITE 200 BRlDGEW ATER, 'iJ 08807-

SUBJECT: Receipt of Registration Application Subject to Registration Service Fee Dear Registrant: The Office of Pesticide Programs has received your application for registration. If you submitted data with this application, the results of the PRN-86-5 screen will be communicated separately. During the administrative screen, the Office of Pesticide Programs has determined that this Action is subject to a Pesticide Registration Service Fee as defined in the Pesticide Registration Improvement Act. The Action has been identified as Action Code: A54 

### NEW PRODUCT;NON-F AST TRACK;FIFRA SEC. 2(MM) USES; You may be eligible for a full or partial waiver of the fee. Refer to OPP's Fee for Service web site at \v\V\v.epa.gov/pesticides/fees for guidance on hO\v to request a waiver. Please remit payment in the amount of: $ 

### 4,000 to: By USPS: USEPA Washington Finance Center Pesticide Registration Service Fee PO Box 360277 Pittsburgh, PA 15251

# I



# , By Courier: U.S. EPA. Washington Finance Centcr Pesticide Registration Service Fee 

### CIO MeHon Client Service Center 500 Ross Street. Room 670 

### Box 360277 Pittsburgh. PA 15251·6277 Attn: EPA Module Supervisor**-~.~--.~** ..**--~**

All payments must be in United States cilrrency by check, bank draft, or money order drawn to the order of the Environmental Protection Agency. To ensure proper credit, please write the OPP DECISION NUMBER on yom check, and enclose a copy of this letter with your payment. If 

### you have any questions, please 

### contacI the Pesticide Registration Service Fee Ombudsman at (703)**308~8260.** Sincerely. 

# &.**~** 

# . I. 

# j}Pd,.>**~d** Processlng Staff

Information Resources and Services Division.... 

### _-------------------- 

# [ fee for Service [



# I

o This item is NOT subject to FFS action. 

# , Action Code: 

# /1:7,7 Amount Due: 

# $ 

# I;;{OOO. 00 Voluntary Payment Reduction Amount:
0 0% 

### 040% 080% 

### Original Decision 

## #: 010% 

### 050% 090% 020% 

### 060% 0100%

. 

### 025% 070% 

# o Other 

# D030% 

### 075% _% 

# Reviewer:

# Aifo/i1)/!1c~ Remarks: ' Date: 

# 1/'b -z;o 

# r

FFS cover shee! revision 3-----"-,



# .**~,.** 

# ,,.,., . Fo"" .d. OMS N, 

## , ',,",'N '-28-9' 

# &EPA Unitod SIel05 

### Environmental Protection Agency Washington, DC 20460 

# r---- Registration I--- Amendment 

### Other 

# I OPP Identifier Number



### , for , 

## - II I. '
4: CompanylProduct !Namo) 2, EPA Product Manager 

### PM'j3 3. Proposed CI88sificotion 

# o None 

# D Restricted AR Granules**(Alaae~Resistant** Roofina Granules) 5. Name end Addross of Applicllnt (lnclud6 ZIP Cods) Cantox U.S., Inc. 1011 Route 22 West, Suite 200 Bridgewater, NJ 08807 6. Expedited Reveiw. In accordance with F!FRA Section 3(c){3) (bill), my product is similar or rnentical in composition and labeling to: EPA Reg. No. ______________ _ 

# o ChIc/{ if this is s m,w .ddress

# ~ Amendment· Exploin below. Resubmission in response to Agency letter doled

______ _ Notification· Explein below. D, 

### , - II 

# U 

# o tName

Finll printed labels in ropllons.o 10 Agency leiter dated**~Me** Too· Applicetion. 

# o Other

- Exploin below. Explanation: Use edditionel pegeCsl if ""conery. {For section I and Suclion 11.1

## I~----------------~



# . M.,,,'" _ P,odum"'" 

# I**,~,** Child·Rusislenl Packuging 

# Dy"**~NO** 

### must Unit Packaging r- Ve,

## ~ N.



### "3."" Location of Ner Conlents Informerion



## Iv" II wgl. Welor Solubla Packaging r- Ves 

# I? N. 2. Type of Container

Glen No. per container If**·Yes~** Pockago wgt No. per contQiner

# bJ**~::~'** Paplr

_ •• _. "_. V" Other

### 'S,,,",,,,_-,,~~.**~"!,!,ffi"~"'--I** 4. Sile/s) Relall Cenl_ner ,-2.20-45. '00. aod 300-500 '0", 

## IS 

# r l.--i- of Label Directions t:..::::::.:j On label 6. M.nnur in Which Lobal is Affixed to Product 

# o Other

____________ _
I 

### -IV 

## II. 

## Coo,,,, Poo" , b. Nem. Tillo Area Code! Ear!e Nestmann Authorized U.S. Agent CertifiCation I canify thallhe stalements I heve made on this form end all eltachmenlli therelo are trua, accurele 

### Inl c,;mp'te. I acknowledge Ihat eny knowlinglly false or misleading stalumont mey be punishebll by fino or imprisorbJunl or both under applicable lew.**..~~-:-** •• : Applicetion fIIecelve<l'**~'.** • 'Stamped) 

# ..**f-'-S-'~::C:::CCC::=:=CCCC--------------------'-3-.-n-,.-.----------------------------~~~--1:** 

## •••• :: •••



# .

# "'''U''C~ I 

# k 

# (·<ll \u 

# C**Au~.ri"d** U.S .• ,'m :::::.

## ~-~~~~~~~~----~--------~':''''.

1 4. 0 •••• Typed Nume 5. ere 

### •••• •

Eal!e NeSlmann 

### April 23, 2004 , .. :.

# ~A '"m 8570-' to

... 3.94, , 

## ". "White • EPA File Copy !originill!

# • •


# • • TRANSMIITAL DOCUMENT FOR IKO INDUSTRIES LTD. 1. Name and Address of Submitter: Submitter: IKO Industries Ltd. RR #1, P.O. Box 839, 105084 Highway 7 Madoc, Ontario, KOK 2KO Canada Authorized Agent: Earle Nestmann, Cantox U.S. Inc. 1011 Route 22 West, Suite 200 Bridgewater, NJ 08807 USA 2. Regulatory Action in Support of Which this Package is Submitted: Registration application. 

### 3. Date of Submission: April 23, 2004 

### 4. Application Fee:
The applicant believes that fee category A54 ($4,000) applies to this application for registration since the action is an application for registration of a new antimicrobial product,**non~fast** track, for FIFRA section 2(mm) uses. 5. Bibliography: Volume I:

Volume 2:

Volume 3: ;)**CO~\t** 'S Administrative Volume: Fonns (8570-1 Application x f-eopy, 85704 Confidential Statement of Formula x 2 copies,**8570~27** Formulator's Exemption x I copy,**8570~34** Certification with Respect to Citation of Data); Draft Label x 5 copies; Authorization Letter x I copy Product Chemistry (Guideline References 830.1550, 830.1600, 830.1650, 830.1670, 830.1750,830.1800) Acute Toxicity Studies: Request for Waivers for AR Granules (Guideline References 870.1100, 870.1200, 870.1300. 870.2400, 870.2500 and 870.2600) Volume 4: Exposure Monitoring: Request for Waivers for AR Granules (Guideline References 875.1700,875.1100,875.1200,875.1300,875.1400 and 875.1600) •••• 

# ,- 1\ '**~'** 

# •.•• ' Company Official: 

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# NOi-M""~**C'''W\cL.~:''** Name Company Name: IKO Industries Ltd. Company Contact: Earle Nestmann Tel: (908) 429,9202 Signaturt::·: • • •••••• • •



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### Environmental Protection Agency Weshingten. DC 204&0 

# '0**~** 

### Registration

_ Amendment 

### Other 'for ,- 

### I opp Idontifior Number

I. ComponyfProduct Numb." 2, EPA Product Mllnegor 3. Proposed CI",iflcation 

## 14,. Company/Product (Nome) PM. 

# o NOM 

# 0 Ro,tricted

AR Granules (Aloae-Resistant Roofina Granules) ! 5. Nome end Add,.,,, of Applicant IIfl(:/ud, ZIP Cod.!

Cantox U.S., Inc. 1011 Route 22 West, Su"e 200**Bridgew~r,** 

### NJ 08807 6. Expedned Reveiw. In accordance with FIFRA Section 3(cJ(3} (bllil, my product is similar or identical in composition and labeling to:

EPA Reg. No. _______________ _ 

## U**~** II n.w sdt/r(l$$ Product Name



### . - II Amendmont
- Explain below, Final printed label' In ,op,on,. to 

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# o Agency letter doted

____________ _ Resubmission in rosponse to Agency Icner deted

______ _**~M. Too~**  Applicetion. 

# o Netificetion· Explain below. 

# D Other

- Exploin below.
I • Usa odditional pagelsl iI n"cflSsory. IFor $ecrien I ond Section 11.)



### Section
- III

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### must Unit Peckugino wQt. container Packege wgr cento;ner V' Other (Specify) bulk baas (fabric) 

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6. Menn"r in Which label is AHiJ<lId to Product

Neme

Earle Neslmann 4. Sb:elSI Rateil Container 1·2,20·45,100, and 300·500 Ions
-;'7 Lithograph .• Paper aluod Stencired

,to< , Title 

# o Other 

### -IV 1<0" , Authorized U.S. Agent Certification ,of lob" On label

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### • 

# l &.**O.~e** Applicetien I conify that the statemonts I heve modo on this form and all attachments thcrreto ere true, accurat. anb t:fll'¢lDtte. 5l.coiv.d I ecknowledge thet any knowlinglly falso er mislellding stotoment moy be punishoble by fino or imprisonnlorit"br •• :.**~S'ampod)** 

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# ~4c"cTcyp--Od-cN~0'mJolccl~c1~~~~Lc~~~O::c::::=+:5-,:O-"-0------------------------------------~l.::·· Earle Nestmann 

### April 23, 2004

oro ebselot •. _.-EPAF

.. Copy" Yellow-• OM. No. I"",

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# &EPA .**u_S<~'.** EnVironmental Protection Agency W

... hlngton, oc 20460

N.mo end Addr

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## Formulator's Exemption Statement (40 CFR 162.851 IEPA Alo

. ' •• " • ' •• Can10x u.s., Inc.

## I~ 

# 11:·:·.··;":·1;:·: 1011 Route 22Wesl, Suite 200 Bridgewater, NJ 08807 N_ AR Granules (Algae·Resislanl Roofing Granules) Stotoment Apri123,2004 

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# .. I As an authorized representative of the applicant for registration of the product identified above, I certify that:

(1) This product contains the following active Ingredient(s): Cuprous oxide: 

# •

.. Of these, each active ingredient listed in paragraph (4) is present solely as the result of the use of that active ingredient in the manufacturing, formulation or repackaging 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 (A) or (8) below which paragraph applies:



# D (A) An accurate Confidential Statement of Formula (EPA FORM 8570-4) for the above identified product is attached to this statement. That formula statement indicates, by company name, registration number, and product name, the source of the activo ingredient(s) listed in paragraph (1). 

### OR (6) The Confidential Statement of Formula (CSF) (EPA Form 8570·4) referenced above and on file with the EPA is complete, current, and accurate and contains the information required on the current CSF

.

.. The following active ingredients in this product qualify for the formulator's exemption.**~** 

### Source
. • Aotive Ingredient Product Name Reglstretion Numbe, Cuprous oxide

EPA Form 8670-27 IRoY. 8-951 

### Name and**T~'.** Earle Nestmann. Authorized U.S. Agent Whits
- EPA copy Vollow
- Applloant copy

..**-~-** 

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

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### _---_.**Fo~,** 

## '·...,;..

..... 1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

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

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## • : " ",l.j, PapelWork Reduction Act Notice: The public reporting burden for this collection of infOImaUon is estimated to avcraqe and 0.25 hours per response for reregistration and special review activities, induding time for reading the instructiontCind ; Director, OPPE 9t:lnd comments regarding burden**es~mate** or any other aspect of this collection of information, induding suggestions for reducing InfonnaUon Management Division (2137). U.S. Environmental Protection Agency, 401 M Street, S.w •• Washington, DC 20460. Do not send the completed fonn to this address. 

## :"' : " Certification with to Citation of Data 

# ;" 

# ; 

# ..
, " I ,A, and Telephone Number EPA**RegiS~~~ Q~mb~rile**  Symbol ;.'oc. 10tt Rm"" , I , NJ 08B07 andlor reoresenlative test comoound(s) Date I 

# , General Use Pattem{s) (list all those claimed for this product**usi~** 40 CFR Part t58) Product Name

. If your product is a too% I :l product tabelad for all the same uses on your label. you do nol need to You must I ,tlEPA Foon

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

SECTION t: METHOD OF DATA SUPPORT method only) 

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

## [J I am using the selective method of support (or cite-all option a list o( companies sent offers of**compensa~on** (the Dala Matrix form under the selective method), and have included with this fonn a should be used for this purpose). completed list of data requirements (the Data Matrix fOffiJ musl be used). SECTION II: GENERAL OFFER TO PAY (Required if using the cite-all method Ofwhen using the cite-all option under the setective method to satisfy one or more data requirements] 

# D I hereby offer and agree to pay compensation. to other persons, with regard to the approvat of this apptication. to the extent required by FIFRA

. 

# .- SECTION III: CERTIFICATION

### ~~':'~~' I " . fa ,,,,olm'oo, IhI'

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### ~tioo,,, .,, 0,".0,11-'0 re'po'" I, ,"pport"" by ,II d,l, "bm"""" cit"" 1o Ih, Ii' , form for reregislration. or the Data-Call-In response. In addition. if the cite-aU option or cite-all option under the selective method is

:l**i~~~~~** .1, this application is supported by aU data in the Agency's fites that (t) concem the properties or effects of this product or an idenlical or i II product, or one or more of the ingredients in this product; and (2) is a type of data that would be required to be subm!tted under the dala ; 

# I"'''· in effect on the date of approvat of this application if the apptication sought the initiat registration of a product of identical or similar composition and

I certify that for each eXclusive use study cited in sUPPOrt of this registration or reregistration. that I am the originat data submitter or that I have obtained the written pennission of the originat data submitter to cite thai study. t certify that for each study cited in support of this registration or reregistration that is not an exclusive use study. either: (a) I am the originat data submitter; (b) I have obtained the permission of the original data submiller to use the study in support of this application; (c) all periods of eligibility for compensation have expired for the study; (d) the study is in the public tilerature; or (e) I have notified in writing the company that submitted the study and have offered (I) to pay compensation to the extent required by sections 3(c)(t)(F) andlor 3(c)(2)(B) of FtFRA; and (ii) to commence negotiations 10 determine the amount and tenns of compensation. if any, to be paid for the use of the study. t certify that in all instances where an offer of compensation is required, copies o( all offers to pay compensation and evidence o( their delivery in accordance with sections 3(c)(t)(F) and/or 3(c)(2)(B) of FIFRA are available and will be submitted to the Agency upon request. Should) fail to produce such evidence to the Agency upon request. I understand that the Agency may initiate action to deny, cancel or suspend the registration of my product in conformijy with FIFRA. I certify that the statements t have made on this form and all attachments to it are true. accurate, and comptete. knowingty fatse or misleading statement may be punishable by fine or imprisonment or both under applicable law. I acknowledge that any
Sfgmlture 

# ct,**.~** Date Typed or Printed Name and Tille L**~** 

## >--"'- CC<_ , 

# - April 23, 2004 Earle Nestmann, Authorized U.S. Agent**1(~97)** '"odl 

# " '.S,bm" ,**,,~Ioo,**Cit:<","""FonnApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C,20460PapelWOrkReductlonActNotlce:ThepublicreportingtllwdenforthiscoMectlonoflnformeUonIsestimatedtoaverage0.25hoursperresponseforregislraliQnactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheInstructionsandcompletingthenecessaryforms.SendCOnlrnefllsregardingtheburdenestimateorenyotheraspectofthiscollectionofInformation,Includingsuggestionsforreducingtheburdento:Director,OPPElnronnalionManagementDivision(2137),U.S.EnvironmentalProtectionAgency,40t MStreet,S.w"Washington,DC20460.Donotsendthefonntothiseddress.DATAMATRIXDateApril23,2004EPARegNo.lFlleSymbolIPagetof2AooNcanfslReQistrant'sName&AddressProductCantoxU.S.,11'\C"f011Route22West,Suile200,Bridgewaler,NJ08807.Contact:EarleNestmann,PhDARGranulesIngredientCuprousOxideGuideHneReferenceNumberGuidelineStudyNemeMRIDNumberSubmitterSlarusNot.830.1550Product IdentityandcompositionIKOIndustriesLtd.OWN830.f600DescriptionofmaterialsusedtoproducetheproductIKOlfldustrlesLtd.OWN830.t620DescriptionofproductionprocessNAFOR830.t650DescriptionottormulalionprocessIKOlfldustriesLtd.OWN830.t670DiscusslooofformalionofimpuritiesIKOIndustriesLtd.OWN830.1750Cerli!iedlimilsIKOIndustriesLtd.OWN830.1800EnforcementanalyticalmethodIKOIndustriesLtd.OWN870.1100AcuteoraltoxiCityIKOInduslriesLtd.OWNRequestforwaivel870.1200AcutedermaltoxicityIKOIndustriesLtd.OWNRequestforwaivel870.t300AcuteinhalationtoxicityIKOInduslriesLtd.OWNRequestforwaiver870.2400AcuteeyeirritationIKOIndustriesLtd.••• •OWNRequestforwaiver••••••870.2500AcutedermalinilationIKOIndustriesLtd.•••••Requestforwaiver••••••OWN870.2600SkinsensitizationIKOIndustriesLtd.OWNRequesttorwaiver875.1100Dermelexposure·outdoorIKOIndustriesLtd.:..: :•••:Requesttorwaivel•••Dermalexposure-IfldoorIKOIndustriesLtd.•••••••••Requasttorwaiver875.1200• ••••OWN'Signature(\cNameandTiUeDateEarleNestmann,AuthorizedU.S.AgentApril23.2004EPAForm8570-35(9-97)ElOCtrorncandPaperversionsavailable.SubmijonlyPaperversion.AgencyInternalUseCopy,-",. nIUNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460FormApprovedOMBNo.2070-0060PapefWorkReductionActNotice:ThepublicreportingburdenforthiscollectionofInformationIsestimatedtoaVefage0.25hoursperresponseforregistrationactiviUesand0.25hoursperresponseforreregistrationandspecialreview activities,Includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.SendcommentsregardingtheburdenestimateoranyoIheraspectofthiscoNectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137).U.S.EnvirOnmentalProtectionAgellCy,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateApril23,2004AJ)pllcanl'slReQistranl'sName&AddressCantoxU.S.,Inc.,1011Route22West,Sulle200,Bridgewater,NJ08807,Conlact;EarleNestmann,PhDIngredientGuideijneReferenceNumberGuidelineSltJdyNemeMRIDNumber875.1300InhalaUonexposure-outdoor875.1400Inhalationexposure-indoor875.1600Applicationdata875.t700ProductUseInformationSignature!.SubmHIEPARegNoJFileSymbolProductARGranulesSubmitterIKOIndustriasltd.IKOIndU5lr1esltd.IKOIndustriesLid.IKOIndustriesltd.NameandTiUe••• •...............•••••••••••........••••••••• ••••••••EarleNestmann,AuthorlzedU.S.AgentAgencyIStatusOWNOWNOWNOWN••••••• •eCopyPage2of2NoteRequestforwaivelRequeslforwaivelRequestforwaiveDateApril23,2004

# • •


# • • IKO INDUSTRIES LTD.
AR GRANULES (ALGAE-RESISTANT ROOFING GRANULES) FOR CONTROL OF ALGAE IN ROOFING SHINGLES ACTIVE INGREDIENT: CUPROUS OXIDE

........... 6% INERT INGREDIENTS

......................................... 94%

CAUTION TOTAL

....................... IOO.O% EPA Reg. No. EPA Est. No. Net Contents: (lbs)

KEEP OUT OF REACH OF CHILDREN DIRECTIONS FOR USE 

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### • •••• It is a violation of Federal Law to use this product in a manner inconsistent with its labeling. If granules are to be stored prior to and during use, a copy of this label must be readily accessible to employees when they are in their work area. For use in the manufacture of roofing shingles. AR Granules should be mixed with standard roofing granules at a rate**of2~** I 0% by weight and processed normally during manufacture of the shingles. For applications where algae growth is severe, unifonnly blend with standard roofing &'Tanules at a rate not to exceed 20% by weight.



### STORAGE AND DISPOSAL Do not contaminate water. food. or feed by storage or disposaL Pesticide Storage: Store under ambient conditions. Pesticide Disposal: Wastes resulting from the use of this product may be disposed of on site or at an approved waste disposal facility. Container Disposal: Railcars and trucks

- completely empty container into application equipment and thoroughly clean prior to refilling. Paper and plastic bags

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# • •**~** 

### completely empty bag into application equipment. Do not reuse bag. Dispose of empty bag in a sanitary landfill, or by incineration, or if allowed by state and local authorities, by burning. Ifbumed, stay out of smoke.

Manufactured by IKO Industries Ltd. R.R.#J, P.O. Box 839 105084 HW#7 Madoc, Ontario, Canada 

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# • • ,,_. INDUSTRIES LTD.
Tuesday, April 13, 2004 Registration Division**(TS~767C)** United Stated Environmental Protection Agency Washington, DC 20460 Dear Sir Of Madam: The purpose of this letter is to notify the United Stated Environmental Protection Agency that Cantox U.S., Inc. is the authorized agent for IKO Industries Ltd. The United States address is: •••••• IKO Chicago Inc. 6600 South Central Ave. Chicago, Illinois 60638 

### IKO Production Inc. 1200 Main Street Franklin, Ohio 45005 IKO Production Inc. 1200 Main Street 

### Franklin, Ohio 45005 IKO Pacific Inc. 850 West Front Street Sumas, Washington 98295-9634 

### Cantox U.S., Inc. 1011 Route 22 West, Suite 200 Bridgewater, NJ 08807 The contact for the authorized agent is: 

### Earle Nestmann, PhD Vice President Tel: (908) 429-9202 Fax: (908) 429-9260 Email: enestmann@cantox.com Sincerely,

# ~-**~-** Annmeza Wong Environmental Engineer

c.c. Gord Stoute, Plant Chemist, IKO Industries Ltd
- Madoc Facility 

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87 ORENDA ROAD. BRAMPTON. ONTARIO l6W 1V7. TEL.(905) 457-2880. FAX.(905} 457-4691

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• • VOLUMEl

ADMINISTRATIVE VOLUME

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### Pages 60 through 71 contain Product Confidential Statement of Formula and are not included in this copy.

### Page 72 contain Product Ingredient Source Information and is not included in this copy.

### Page s 7 3 through 74 contain Product Confidential Statement of Formula and are not included in this copy.