# EPA Registration No. 81293-1 Volume No. 2, ;, , 

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# Instructions: Attachthis notice on top ofthe' i" 

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# withthis**cov~rsheet**

# to staff in the Information Services Center (Room 23(». " '.' ". ' ' , ,

. Current as of

### Y'I~dnesday. May 10. 2006

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

### 20460

Ms. JessicaWalsh, Regulatory Consultant for, Cantox U.S., Inc. 1011 Route 22 West, Suite 200 Bridgewater, NJ 08807 

# JUN 09 2008 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Subject: AR Granules(Algae-Resistant Roofing Granules) EPA RegistrationNumber 81293-1 YourAmendmentDated April 4"', 2008 EPA Received DateApri14'h, 2008 The amendmentreferred to above, submitted in connection with 

### registrationunder the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, to revise the manufacturingprocess, is acceptable. The Confidential Statements ofFonnula dated February 29th
, 

### 2008, is consistentwith the label declaration and is acceptable. Atthe nextprinting ofthe labeling, revise the label declaration to includethepercentage ofmetallic copper of3.88% as a footnote to appearbelow the ingredient statement. A stamped copy ofthe labeling is enclosed for your records. Ifyou have any questions concerning this letter, please contact Karen M. Leavy at (703)-308-6237. Sincerely,

Marshall Swindell Product Manager 33 RegulatoryManagement Branch I Antimicrobial Division(7510P)

## IKO INDUSTRIES LTD. AR GRANULES (ALGAE-RESISTANT ROOFING GRANULES) FOR CONTROL OF ALGAE IN ROOFING SHINGLES ACTIVE INGREDIENT: CUPROUS OXIDE.
..........4.37% INERT INGREDIENTS.........................•...•...........95.63%

CAUTION TOTAL
.......................IOO.O% EPA Reg. No. 81293-1 EPA Est. No. 081352-CAN-OOl Net Contents: 2 tons

KEEP OUT OF REACH OF CHILDREN PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS Harmful 

### ifswallowed. Wash thoroughlywith soap and wate after handling and before eating! drinking, chewing gum, or using tobacco. 

### FIRST AID: If

### Swallowed: 

### Call a Poison Control Centre or doctor immediately for treatment advice. Have person sip a glass ofwater if

### able to swallow. Do not induce vomiting unless told so by 

### a Poison Control Center or doctor. Do not give anything by mouth to an unconscious person. 

### DIRECTIONS FOR USE It 

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

### For use in the manufacture ofroofing shingles. AR Granules should be mixed with standard roofing granules at a rate of2-1 0% by weight and processed normally during manufacture ofthe shingles. For applications where algae growth is severe, uniformly 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. Pesticide Disposal: Wastes resulting from the use ofthis product may be disposed ofon 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

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

Manufactured by IKO Industries Ltd. R.R.# 1, P.O. Box 839 105084 HW#7 

### Madoc, Ontario, Canada 

### KOK2KO Un&r1M**Fgd~!al !~** ..::tic'.dG**F\lO~:;idd,"** '_-,<"**,',;....J,".t;:,.y~** &1 as**ama:ld',,~~<:** ._"','**.~:_ regJ."b:·F:~**  -11. No.

# ~I 

# '[Q3-/(ALERT) 

### s: 827088 (ALERT) 8: 82568:5 (ALERT) 8: 820811 I:') 

## iii 8: 812601 612612007;**A~ndlfl(;flt,·** 81293 

# ttl··a D: Closed; ""613; 8"";',; .. 

# ""';';;;'p,,**~;;U( ~~--------**  , 

### Recommendation ofDivision Directors Negotiated Due Dates**--~---------~--~-------~------"'-------,------ jll:d~;ion#:**  

### ?;SH723 Petition #: PRIA Decision Time 

### Fnllnc: 12Hdays
:

### ~·;uhmitt!.'u 

### by: Karen Le8V}' 

### i-- ----------------. Branch: RMBI 

### Date: 11129/211117 I 

### ('omp:.wy: Canto); L!.S., Inc.**i----~-** 

## ----------.-------------- 

# I Original Due Dat!': j 

### 113012007 Proposed Nen' Due Date: 03/30/08

___________ .-L ____________________ _

r..S:>tK 

### (ucscdbe in .kl;,diJ: C:mLox U.S., Inc, submitted chemistry data, Confidential Statement or Vomw!:t. i 

### and product labeling to support a refined manufacturing process. The CSF h<ls been foullo 

### to he 

# i unaccl.'ptahk. 

# r'**!-)~;~;"i-b-c T;;-i~-r;-l**  

## c-',

I"]

### :-"-IS-'-,,-c, 

### j"CthC-:CC"' ,-,,-n-p-a-n-)-'-:( d"Oc-s-c-l'""i 1c-,e-,,-;' I-JC-n-co-n-'-t.-c-:t-e-;d-a-n-dc--c-o-n-11-,,-m-)-:' :-s-'-'c-s-p-o-n-sc-'';";,-,c-'IC-u-<l:-i

## -n-grti.'S11**iHl.~**

### e to

### pn~Yious 

### negotiated due da1cs): On November 1611\ 

### 2007, Jessica 

### Walsh, f'cgistration COilsu!hlill of

### C:mlw'I: ! 

### U.S., file. was contacted to discuss the chemistry deficiencies. On November 20(h, 2007, il 

### reviSl'd ('SF, <lad

product labeling**\V~lS** 

### e-mailed to the Agency to address the chemistry deficiencies. The ret'ised ('SF :mll product hdJd 

### shm\' a coo,,{'ntration ofactive 

### ingl'edient at**4.37\~)** 

### instead ofa cOllcentration nf6**~y;~. ,k,,,~it";l**  

### \hd.'ih, 

### rcgistration I..'OH[wirrallt 

### for C:ll1tox U.S., [nc., has been 

### informed that product**chcmistr~,'** 

### {hit

.. 

### hased Oli 

### til!'**I1C\~'** 

### cOllccntr.atEon of**·L37~%** 

### must be 

### generllted and submitted to thc Agency for OUl' 

### rcvlc\\. On '\(j\-.:.'milcr 

### 28 1[', 

### 20H7, tlle company requested via e-mail a nO-day timc extension from the "fix"**dilt~'** 

### of ! 

### 1I30107 to 

### Agency to 

### address the outstanding chemistry 

### deficiencies. c--------------..-



### H.;ltion<1 ic for Propm;('<i Due Date: The 120-day time extension request of(03/30/08)1'1'0111 the "fix" date (If i 

### 1iJ30107 ,\'ill 

### <llIow CaI:1i"ox, 

### U.S., inc., enough time to address the chemistry deficiencies. AI) recommends
,**U~~**

### a**120~day** 

### time cxtcmilJEIJw 

### granted. _ ..___,,_, (.Hilcr ('omWlt'nis/Dtfi-riCi'{::. 

### T:rrw: 1"!'Oi.lllfi C!H'mi:iti'Y: ._..

# 2L. :,1'111fe 

### Tox:
. __" Effie<lcy:' _ Labeling: X Other:

. 

### ------------ --**-~~~~~~~~~~ ,-,~---**  --,.,'- ,-_._---------_._-_.- ._---**--.--.-"--~-------------.- ._~No**  

### \VlIy Not?
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# l[-30 '0'7 -\--\\--\',---"'=\#\----------'----- 

# -J---- on 0:-' 

# non I"agmlfurc:Gentlemen, Karen LeavylDC/USEPNUS 11/29/200702:19 PM To Dennis Edwards/DC/USEPA/US@EPA,Marshall SwindeIlIDC/USEPAlUS@EPA 

### ee bee Subject Fw: IKO AR Granules

Here is the 120 day time extenS'lon request from Cantox" Inc. KML ,."-- Forwarded by Ka!Eil Leavy/DC!USEPAIUS on 11/2912007 02:18 PM -'---

Hello Karen;"Jessica Walsh" <jwalsh@cantox.com> 11/29/2007 01:43 PM To Karen leavy/DC/USEPAlUS@EPA, Chris J ia ng/DC/USE PAlUS@EPA 

### ee Subject IKO AR Granules

We are requesting a -;20 day extension from the date of November 

### 30'", 2007. I am "l' iding a priority overnight courier with the requested information today, in addition to an email COllt: !!iing the files. If you have any questions. please do not hesitate to contact meKindest Regards, Jessica

### Recommendation ofDivision Directors Negotiated Due Dates Decision#: 380723 

# IRegistration#:81293-1 \ Petition #: 

## I Fee Category: AS7 PRIA Decision Time Frame: 120days Submitted by: Karen Leavy Branch: RMBI 

# IDate: 02121108 Company: Cantox U.S., Inc. I 

### Original Due Date: 03/30/2008 

# IProposedNew Due Date: 05/29/08 PreviousNegotiated Due Dates: NIA Is the "Fix" in-house? Yes 

# Ilfnot, date "Fix" expected: Issue (describe in detail): Cantox U.S., Inc. submitted an applicationwhich included a revised Confidential 

# , Statement ofFormula, labeling, a description ofthe refined formulation process to the Agency for review. Upon review ofthe submitted chemistry data/information, the revised Confidential Statement ofFormula, labeling and description ofthe refined formulation process showed the concentration ofactive ingredientto be at 4.37% instead of6%) 

### when the productwas originally registered with the Agency. It

### was determined that in order for Cantox to change the concentration ofthe active ingredient, a new set ofproduct chemistry I 

### data will have to be generated and submitted for our review. I 

### Describe Interactions with Company (describewhen contacted and company's response including response to previous negotiated due dates): On November27th, 2007the companywas contacted via e-mail concerning the chemistry deficiencies. She stated that the company will submit a new set ofproduct chemistry data to support the change in concentration ofactive ingredient. The company will 

### need to extend the current PRIA due date in order to generate the new product chemistry data. On February 20th
, 

### 2008, a timc extension requestwas e-mailed to extend the due date to 

## 05129/08. This time**ext~nsion** 

### will give the company 

# I enough time to generate the new product chemistry data and submit it to the Agency for our review. I 

### Rationalefor Proposed Due Date: The90-day time extension will allow the company to generate the needed \ product chemistry data and allow time for the Agency to review the data. Other CommentslDeficiencyType: Product Chemistry: X Acute Tox: Efficacy:**Labelin~:** 

### Other: "75 Day" Lettcr appropriate? X Ves No Why Not? Registrant**notifie~that** 

### this is the last negotiation? __ Ves X No Why Not? This is the first reI 

# I - --**n~gotiation.** 

### i 

### Approve: 

# V IDisapprove: 

# i If

### disapproved, action to be taken: 

## I '\ 

## , (1 d

### ~ r\ , 

# ,\! ' , 

# \ \ \ \ r )**~** 

### , 

### OD orDOD Signature:**~'i** 

### Date: I 

# Ii '"L 

# \ i \ 

# 7-0< [Jot 

# II, I

# v,'lX /} 

## 'i \ ' )' \, V ; ; 

## , \Dennis, Karen Leavy/DC/USEPAlUS 02121/200804:33 PM To Dennis Edwards/DC/USEPAlUS@EPA, Marshall Swindell/DC/USEPAlUS@EPA 

### cc 

### bee Subject Fw: AR Granules Amendment * PRIA Extention Request

Here is the time extension write up and copy ofthe 75*day letter for Cantox, Inc. The time extension request from the registrant is below.

75 da}lletlerfor 81 293·1 .doc 81293·1 timeex.doc
KML

--- Forwarded by Karen Leavy/DC/USEPAlUS on 02/21/2008 04:31 PM
---- "Jessica Walsh" <jwalsh@cantox.com> 02/20/200802:54 PM



### Hello Karen; 'UPDATED' To "Jessica Walsh" <jwalsh@cantox.com>,Karen LeavyIDC/USEPAlUS@EPA, "Henry Jacoby" <hjacoby@actagroup.com> cc "Annmeza Wong" <Annmeza.Wong@IKO.com> Subject RE: AR Granules Amendment
- PRIA Extention Request



### Acting on behalf of IKO Industries, I am requesting a time extension with a "fix" date of February 29'", 2008. IKO Industries Inc. is requesting to extend the PRIA due date 90

, th Ih 

### days from the "fix' date of February 29 , 2008 to May 29 , 2008. Please do not hesitate to contact me should you have any questions on concerns regarding the issue discussed above. I can be reached 

## via email at jwalsh@cantox.com, or 

## via telephone (905)542-2900 ext. 266. Kindest Regards Jessica Walsh Toxicologist Cantox Health Sciences International 2233 Argentia Road, Suite 308 Mississauga, Ontario L5N 2X7 Telephone: (905)542-2900 ext. 266 Fax: (905)542-1011jwalsh@cantox.com www.cantox.comChris, ..Henry Jacoby" <hjacoby@actagroup.com> 05/2212008 10:54 AM To Chris Jiang/DC/USEPAfUS@EPA cc "Jessica Walsh" <jwalsh@cantox.com> 

### bee Subject AR Granules

As per your request as to clarify the sentence on page 79 of report A:

, Cuprous oxide, and pigments."

. Ifyou have any questions, please call.
Henry (Hank) Jacoby, M.S. THE ACTA GROUP, L.L.C. 1203 Nineteenth Street, NW Suite 300 Washington, D.C. 20036-2401 hjacoby@actagroup.com (301) 865-9090 (phone) (202) 557-3836 (fax) Please visit our Web Site at http://www.actagroup.com This e-mail may contain confidential or privileged information. Ifyou are not the intended recipient, please advise by return e-mail and delete immediately without reading or forwarding to others.Hi Karen; nJessica Walsh" <jwalsh@cantox.com> 01/24/200807:17 PM To Karen LeavyfDCfUSEPAlUS@EPA 

### cc bee Subject RE: FW: IKG/US EPA

0000000 0 00 0000 0 0 0 0**~** ,This message has been replied to.**~"** _**,,~,** 'A'

I'm sorry, I was out of the office today and did not receive your email until just now. We have contacted a laboratory that has agreed to conduct the density study under GLP. From my conversations with Chris, I believe that this is the only requirement that needs to be updated in this manner. I am available for a meeting, are you suggesting a telephone conference? Jessica**--~--Original** Message----- From: Leavy.Karen@epamail.epa.gov [mailto:Leavy.Karen@epamail.epa.gov] Sent: Thu 24/01/2008 1:31 PM To: Jessica Walsh Subject: RE: FW: IKO/US EPA Jessica, I am follow up on your e-mail. I spoke with Chris this afternoon and I'm still a little confused. He told me that he has not received any data/information from you. I am a little concerned because the re-negotiated due is March 11, 2008. If the chemistry data is submitted next week, he will NOT have enough time to review it. If you decide to stay with the 6% as per our registration records, the Agency would need Group A product chemistry, a revised manufacturing process that agrees with a revised product label and Confidential Statement of Formula. If you decide to reformulate to 4.35%, then the Agency will need Group A 

### & B product chemistry data, Certificate of Analysis, if using an unregistered source of active ingredient, revised Confidential Statement of Formula, and labeling that agree. Could let me know what you are doing in terms of your product chemistry? If we are still confused with what is going on with the submission of product chemistry data, I will set up a meeting with Chris, Dennis Edwards, my Branch Chief and Marshall Swindell to iron out what needs to be done so everyone is very clear. I might need another time extension depending upon what your company is doing in terms of generating the required chemistrY data.

"Jessica walsh" <jwalsh@cantox.c om> 

### KML

Karen Leavy/DC/USEPA/US@EPA ToHi Karen; 12/03/2007 11:11 AM RE: FW: IKO/US EPA 

### cc Subject

Thank you for the update. I will email Chris the data contained in the package in the meantime so he can have a look and make a decision either way. Thank you very much Jessica -----Original Message----- From: Leavy.Karen@epamail.epa.gov [mailto:Leavy.Karen@epamail.epa.govl Sent: December 3, 2007 10;44 AM To: Jessica Walsh Subject: Re: FW: IKO/US EPA The chemistry data will leave the mailroom in Washington, D.C. and come to the document processing center in Crystal City, VA. Upon reciept of the data, it will be assigned a MRID# for each study. Then, it will be routed to the PM team. As soon as I receive it, I will route it to the Product Science Branch for review. This process may take 1-2 weeks. Thanks for the update.
KML

"Jessica Walsh" <jwalsh@cantox.c om> 12/03/2007 10:16 AM Chris Jiang/DC/USEPA/US@EPA, Karen Leavy/DC/USEPA/US@EPA "Louise Bingley" <lbingley@cantox.com> 

### To

cc Subj ect FW: IKO/US EPA

### Hi Karen and Chris; I was wrong when I said the package was sent on Friday

- we couriered it on Thursday, and it was indeed received at EPA on Friday. See below the address and receipt notice. Jessica
From: Louise Bingley Sent: December 3, 2007 10:14 AM To: Jessica Walsh Subject: RE: IKO/US EPA Hi Jessica Here is the Address I sent it to - pulled right from the EPA Staff locator Website. Chris Jiang USEPA Headquarters Ariel Rios Building, MC: 7510P 1200 Pennsylvania Avenue, N. 

### W. Washington, DC 20460 

### US 7033050545 Also: Here is the Signed for information Signed for: J.CAMPBELL
- Mailroom. Ship date

Nov 29, 2007 Delivery date

Nov 30, 2007 9:59 A From: Jessica Walsh Sent: December 3, 2007 10:10 AM To: Louise Bingley Subject: IKO/US EPA Hi Louise; Can you please send me the address that you couriered the US EPA? They haven't received it yet.

Jessica Walsh Toxicologist Cantox Health Sciences International 2233 Argentia Road, Suite 308 Mississauga, Ontario L5N 2X7 jwalsh@cantox.com www.cantox.com"Jessica Walsh" <jwalsh@cantox.com> 01/03/200802:59 PM To Chris Jiang/DC/USEPAlUS@EPA cc Karen Leavy/DC/USEPAlUS@EPA bee Subject RE: GLP requirements**~** AR Granules Amendment**.~'**__**,e,,~_,_._,_,'~" -'~"'-'~"C"~--.'C"'""--'"'** **~ This_~~~agEl** **fl~s_,~een repUed~o.**  Thanks! ---Original Message----- From: Jiang.Chris@epamail.epa.gov [mailto:Jiang.Chris@epamail.epa.gov] Sent: January 3, 2008 2:54 PM To: Jessica Walsh 

### Cc: Leavy.Karen@epamail.epa.gov Subject: RE: GLP requirements

- AR Granules Amendment No, I need the formal write-up of the study.

"Jessica Walsh" <jwalsh@cantox.c om> 01/03/2008 02:29 

### PM Chris Jiang/DC/USEPA/US@EPA, Karen Leavy/DC/USEPA/US@EPA 

### To

cc Subject

Hi Chris; RE: GLP requirements

- AR Granules Amendment

Will a Analytical "Certificate of Analysis (CofAl" be sufficient without a formal report write-up? Jessica

-- -Original Message--
- From: Jiang.Chris@epamail.epa.gov (mailto:Jiang.Chris@epamail.epa.gov] Sent: January 3, 2008 12:48 PM To: Jessica Walsh; Leavy.Karen@epamail.epa.gov Subject: Re: GLP requirements AR Granules Amendment NO certifications are required, just the lab conduct the study under GLP, and triplicate results may be submitted and the premise of analysis in triplicate is acceptable; however, I don't know if the results will be until the study is submitted.Hello Chris; .. Jessica Walsh" <jwalsh@cantox.c om> 01/03/2008 11:15 AM Chris Jiang/DC/USEPA/US@EPA, Karen Leavy/DC/USEPA/US@EPA 

### To

cc Subject GLP requirements

- AR Granules Amendment

I have had a question from the lab that is handling the GLP analysis of density for the 

### AR Granules product. Typically the lab would provide a single density results as 

### a value only, and do not typically prepare a report. If required, results can be provided in triplicate. will this satisfy the requirement? Also, are any specific certifications required? Any help that you could offer on this issue would be greatly appreciated. Thank you. Jessica walsh Toxicologist Cantox Health Sciences International 2233 Argentia Road, Suite 308 Mississauga, Ontario 

### L5N 2X7 Telephone: (905) 542-2900 ext. 266 Fax; (905) 542-1011 jwalsh@cantox.com www.cantox.com..Jessica Walsh" <jwalsh@cantox.com> 01/03/200812:49 PM

Thanks Chris! I'll pass on the message. Jessica -----Original Message----- To Chris Jiang/DC/USEPAlUS@EPA, Karen Leavy/DC/USEPAlUS@EPA 

### cc bee Subject RE: GLP requirements
- AR Granules Amendment

From: Jiang.Chris@epamail.epa.gov [mailto:Jiang.Chris@epamail.epa.gov] Sent: January 3, 2008 12:48 PM To: Jessica Walsh; Leavy.Karen@epamail.epa.gov Subject: Re: GLP requirements

- AR Granules Amendment No certifications are required, just the lab conduct the study under GLP, and triplicate results may be submitted and the premise of analysis in triplicate is acceptable; however, I don't know if the results will be until the study is submitted.

Hello Chris; "Jessica Walsh" <jwalsh@cantox.c am> 01/03/2008 11:15 AM Chris Jiang/DC/USEPA/US@EPA, Karen Leavy/DC/USEPA/US@EPA 

### To

cc Subject GLP requirements

- AR Granules Amendment

I have had a question from the lab that is handling the GLP analysis of density for the AR Granules product. Typically the lab would provide a single density results as a value only, and do not typically prepare a report. If required, results can be provided in triplicate. will this satisfy the requirement? Also, are any specific certifications required? Any help that you could offer on this issue would be greatlyappreciated. Thank you. Jessica Walsh Toxicologist Cantox Health Sciences International 2233 Argentia Road, Suite 308 Mississauga, Ontario LSN 2X7 Telephone:**(90S)S42~2900** ext. 266 Fax: (905)**S42~101l** jwalsh@cantox.com www.cantox.comHi Kareni "Jessica Walsh" <jwalsh@cantox.c om> 12/03/2007 11:11 AM TO Karen Leavy/DC/USEPA/US@EPA 

### cc Subject RE: FW: IKO/US EPA

Thank you for the update. I will email Chris the data contained in the package in the meantime so he can have a look and make a decision either way. Thank you very much Jessica -----Original Message----- From: Leavy.Karen@epamail.epa.gov [mailto:Leavy.Karen@epamail.epa.gov] Sent: December 3, 2007 10:44 AM To: Jessica Walsh Subject: Re: FW: IKO/US EPA The chemistry data will leave the mailroom in Washington, D.C. and come to the document processing center in crystal City, VA. Upon reciept of the data, it will be assigned a MRID# for each study. Then, it will be routed to the PM team. As soon as I receive it, I will route it to the Product Science Branch for review. This process may take 1-2 weeks. Thanks for the update.
KML

"Jessica Walsh" <jwalsh@cantox.c om> 12/03/2007 10:16 h"l Chris Jiang/DC/USEPA/US@EPA, Karen Leavy/DC/USEPA/US@EPA "Louise Bingley" <lbing1ey@cantox.com> To



### cc Subject FW: IKO/US EPA

### Hi Karen and Chris; I was wrong when I said the package was sent on Friday

- we couriered it on Thursday, and it was indeed received at EPA on Friday. See below the address and receipt notice. Jessica
From: Louise Bingley Sent: December 3, 2007 10:14 AM To: Jessica Walsh Subject: RE: IKO/US EPA Hi Jessica Here is the Address I sent it to - pulled right from the EPA Staff locator Website. Chris Jiang USEPA Headquarters Ariel Rios Building, MC: 7510P 1200 Pennsylvania Avenue, N. W. Washington, DC 20460 

### US 7033050545 Also: Here is the Signed for information Signed for: J.CAMPBELL
- Mailroom. Ship date

Nov 29, 2007 Delivery date

Nov 30, 2007 9:59 A From: Jessica Walsh Sent: December 3, 2007 10:10 AM To: Louise Bingley Subject: IKQ/US EPA Hi Louise; Can you please send me the address that you couriered the US EPA? They haven't received it yet.

Jessica Walsh Toxicologist Cantox Health Sciences International 2233 Argentia Road, Suite 308 Mississauga, OntarioL5N 2X7 

### jwalsh@cantox.com www.cantox.comHi Chris; "Jessica Walsh" <jwalsh@cantox.com> 12/03/200711 :14 AM To Chris Jiang/DC/USEPAlUS@EPA cc Karen Leavy/DC/USEPAlUS@EPA, "Louise Bingley" <Ibingley@cantox.com> 

### bco Subject IKO AR Granules Chemistry data

As per our telephone conversation this morning, please find attached the dossierthat was couriered to you on Thursday, and according to Karen will arrive as a hard copy for you to review in 1 to 2 weeks. Please do not hesitate to contact me 

### if there's anything that I can do to expedite the review. Kindest Regards,
JesslcaWalsh Toxicologist Cantox Health Sciences Intemational 2233 Argentia Road, Suite 308 Mississauga, Ontario L5N 2X7 jwa1sh@cantox.com www.cantox.com 

# 'm

Conlidential Statement of Formula -IKO AR Granules
-23 Nov 2007.pdl 

# am 'm Cover Letter- EPA
-29 Nov 2007.doc
Label· IKO AR Granules· 23 Nov'07.pdf 81293·1 Product Chemistr}, [Volume 2j.pdf 

# 'm 81293·1 Product Chemistry (volume 2) Conlidential Attachemenl.pdf"Jessica Walsh" <jwalsh@cantox.com> 12/03/2007 10: t6 AM To Chris Jiang/DC/USEPAlUS@EPA, Karen Leavy/DC/USEPAlUS@EPA cc "Louise Bingley" <Ibingley@canlox.com> bee Subject FW: IKG/US EPA

,

# ,~T~i~:_~~~~~~~h,~s"~~~_e!:~~~~'~,~ __,, , __

# ,"~'__

# A,,_~~ __

# '~~'__

# ,~A __

# ~ _____, Hi Karen and Chris; 

### I was wrong when 

### I said the package was sent on Friday
- we couriered it on Thursday, and it was indeed received at EPA on Friday. See below the address and receipt notice. Jessica**From~** Louise Bingley 

### Sent: December 3, 2007 10:14 AM 

### To: Jessica Walsh 

### Subject: RE: IKO/US EPA

Here is the Address 

### I sent it to - pulled right from the EPA Staff locator Website. Chris Jiang USEPA Headquarters Ariel Rios Building, MC: 75 toP t200 Pennsylvania Avenue, N. W. Washington, 

### DC 20460 

### US 7033050545 Also: Here is the Signed for information Signed for: J.CAMPBELL • Mailroom. Ship date Nov 29,2007 Delivery date Nov 

### 30, 2007 9:59 A 

### From: Jess·lea Walsh 

### Sent: December 3,2007 10:10 AM 

### To: louise Bingley 

### Subject: IKO/US EPA Hi Louise; Can you please send me the address that you couriered the US EPA? They haven't received it 

### yet.Jessica Walsh Toxicologist Cantox Health SCiences International 2233 Argentia Road, Suite 308 Mississauga, Ontario L5N 2X7 jwalsh@cantox,com www.cantox.com"Jessica Walsh" <jwalsh@cantox.com> **11/27/200704:25** PM

Hello Karen; To Karen LeavyIDC/USEPAlUS@EPA cc "Louise Bingley" <lbingley@cantox.com>,Chris Jiang/DC/USEPAlUS@EPA bee Subject IKG AR Granules

In that case, we are requesting a 90-day extension, since the proposed guarantee for the product is 4.37% cuprous oxide. Please let us know as soon as possible if this is possible. please ensure that Louise Bingley is copied on your response. As you can see, this is a very urgent matter. Jessica
--Original MessageFrom: Leavy.Karen@epamail.epa.gov [mailto:Leavy.Karen@epamail.epa.govl Sent: Tuesday, November 27, 2007 1:44 PM To: Louise Bingley Subject: Re: Ms. Bingley, Here is the problem. The revised Confidential Statement of Formula and labeling show the concentration of active ingredient to be 4.37% INSTEAD OF 6% when the product was originally registered with the Agency. In order for Cantox, Inc., to change the concentration of active ingredient, a new set of product chemistry data will have to be generated and submitted for our review. If I do not receive a revised CSF and Labels with the current concentration of 6%, you will have to reqUest a 90-day time extension. If you do not request a time extension by November 28, 2007, the Agency will issue a DO Not Grant Letter for this PRIA action which is due on November 30, 2007.

"Louise Bingley" <lbingley@cantox .com> 11/27/2007 01:00 

### PM KML

Karen Leavy/DC/USEPA/US@EPA Chris Jiang/DC/USEPA/US@EPA, "Jessica Walsh" <jwalsh@cantox.com> 

### To
cc
SubjectDear Ms. Leavy As per our discussions of this morning, I am please to enclose find the requested documentation. I trust that this is satisfactory, please do not hesitate to contact me if you require any further information. Sincerelry Louise A. Bingley Office Administrator

(See attached file: Confidential Statement of Formula

- IKO AR Granules

- 23 Nov 2007.pdf) (See attached file: Label

- IKO AR Granules

- 23 Nov' 07 .pdf)

Confidential Statement of Formula ·IKO AR Granules· 23 Nov 2007.pdf Label-IKO AR Granules· 23 Nov'07.pdfHello Chris; ..Jessica Walsh" <jwalsh@cantox.com> 11/23/200702:55 PM To Karen Leavy/DCfUSEPNUS@EPA, Chris Jiang/DC/USEPNUS@EPA cc "Earle Nestmann" <enestmann@cantox.com> bee Subject AR Granules RegNo. 81293-1
- Amendment Clarification

Please find attached the revised CSF and Label for AR Granules (EPA RegNo. 81293-1). Note that the CSF is signed by Dr. Ian Munro of Cantox for Dr. Earle Nestmann. Dr. Munro is an Executive Vice President of Cantox. Please do not hesitate to contact me should you require anyfurther clarification. Kindest Regards, Jessica Walsh Cantox Health Sciences, In!'1. jwalsh@cantox.com www.cantox.com

Label-IKO AR Granules
- 23 Nov'07.pdl Conliden\ial Statement 01 FOlmula -IKO AR Granules
- 23 Nov 2007.pdf 

# 'Ii AR Granules Deficiencies in CSF 20 Nov '07.pdl..Jessica Walsh" <jwalsh@cantox.com> 01/28/200809:07 AM

Hello Karen; To Karen LeavyIDC/USEPNUS@EPA 

### cc Dennis Edwards/DC/USEPA/US@EPA, Marshall Swindell/Dc/USEPAJUS@EPA 

### bee Subject RE: FW: IKO/US EPA

The number that I can be reached at is: 905-542-2900, extension 266. I understand that only two time-extensions will be granted, and that we have used one of these extensions at this time. It sounds like we will need to use the second extension, but this can be discussed on Wednesday morning. The reason that we have not been in contact with either yourself or Chris recently is that we have been in the process of generating the requested data under GLP, which as you know cannot necessarily be completed in a matter of hours. I look forward to speaking with you on Wednesday. please do not hesitate to contact me with any questions before this. Kindest Regards, Jessica -----Original Message----- From: Leavy.Karen@epamail.epa.gov [mailto:Leavy.Karen@epamail.epa.govl Sent: January 28, 2008 8:52 AM To: Jessica Walsh Cc: Edwards.Dennis@epamail.epa.govi swindell.Marshall@epamail.epa.gov Subject: RE: FW: IKO/US EPA Jessica, I set a meeting up with my Branch Chief, Dennis Edwards, team leader, Marshall Swindell, Chemist, Chris Jiang, and myself for Wednesday at 9:00 a.m. I will need a contact telephone number, so we can call you for the conference call. The reason for the meeting to clarify what is needed and more importantly, the timing of the submission of the data as well as factoring enough review time. The re-negotiated due date is March 11, 2008. This will NOT be enough time for generating, submitting and reviewing the chemistry data. Their seems to be some type of disconnect as to what data requirements need to be fulfilled because the chemist is unclear about what concentration is being tested of the active ingredient. Hopefully, we will have the meeting so that everyone is on the same page. A second tim'e extension will have to be granted. The Agency ONLY grants two time extensions. If this is not resolved on the second time extension, then the Agency will issue a DO NOT GRANT letter. When you do submit after the Do Not Grant letter, the submission fall under FQPA with new timeframes instead of PRIA II. please provide me with a contact number and if wednesday morning at 9:00 a.m.
KML

"Jessica Walsh"Hi Karen; <jwalsh@cantox.c om> 01/24/2008 07:17 

### PM To Karen Leavy/DC/USEPA/US@EPA cc Subject RE: FW: IKO/US EPA

I'm sorry, I was out of the office today and did not receive your email until just now. We have contacted a laboratory that has agreed to conduct the density study under GLP. From my conversations with Chris, I believe that this is the only requirement that needs to be updated in this manner. I am available for a meeting, are you suggesting a telephone conference? Jessica -----Original Message----- From: Leavy.Karen@epamail.epa.gov [mailto:Leavy.Karen@epamail.epa.gov) Sent: Thu 24/01/2008 1:31 PM To: Jessica Walsh Subject: RE: FW: IKO/US EPA Jessica, I am follow up on your e-mail. I spoke with Chris this afternoon and I'm still a little confused. He told me that he has not received any data/information from you. I am a little concerned because the re-negotiated due is March 11, 2008. If the chemistry data is submitted next week, he will NOT have enough time to review it. If you decide to stay with the 6% as per our registration records, the Agency would need Group A product chemistry, a revised manufacturing process that agrees with a revised product label and Confidential Statement of Formula. If you decide to reformulate to 4.35%, then the Agency will need Group A 

### & B product chemistry data, Certificate of Analysis, if using an unregistered source of active ingredient, revised Confidential Statement of Formula, and labeling that agree. Could let me know what you are doing in terms of your product chemistry? If we are still confused with what is going on with the submission of product chemistry data, I will set up a meeting with Chris, Dennis Edwards, my Branch Chief and Marshall Swindell to iron out what needs to be done so everyone is very clear. I might need another time extension depending upon what your company is doing in terms of generating the required chemistry data. KMLCalendar Entry 

# Meeting C Notify me 

### L Mark Private t'" ""._.. _ .. " -.**~** ... .,..• -- - liTo discuss the chemistry data deficiencies with the pending 

## H

PRIA amendment with Jessica Walsh, regulatory consultant

### _i~for,**Can:_?~~_!nc.** 

### tCQair

# r\~ih~re -;:-Karen Leavy/DC/USEPAIUS Subject

When 

# ICategorize

Invitees

..

Chris Jiang reviewed product chemistry data. It was deficient. Company submitted a revised manufacturing process;however the concentration of active ingredient changed from 6% to 4.35%. Chris and Jessica Walsh discussed the chemistry data requirements forthe 6% and new data requirements for a 4.35%. Communication seems

### to have broken down. Meeting suggested to discuss how the company is going to address the chemistry data requirements. Company extended the PRIA due date once to March 11,2008. Chris has indicated that he will not have enough time to review the chemistry data. Discussion is needed with registrant to determine how it is going to address the pending chemistrydata requirements. 

# IYour Notes 

# ....,

# I I I 

## I DECISION PKG. NO. 

# ':ri5"'b 

# rt3
SUBMISSION BAR CODE, 

### #

# t 21-Q

# I'i? SUBM. DUE

# rlftt//2/zC;/og**REVIEWER-+~-'L'7'** _____ _ 

## CODING FORM FOR APPLICATIONS FOR REGISTRATION/AMENDMENTS
FILE SYMBOL/REG NO. 

# ?;Zct5-/ p,.3.3" ACTION CODE

# A~fD DESCRIPTOR ____ ---,-_______ 

# FQPA__ NFQPA. __ [ J CHILD RESISTANT PACKAGING: 1 REQUIRED 

### NOT REQUIRED REGISTRATION TYPE: 

### 1 CONDITIONAL UNCONDITIONAL 1 RESTRICTED USE DATE ON APPLICATION



# ()lG 0'1 DR' EPA RECEIVE DATE

# ~/

# .-2.!LfiL PM RECEIVE DATE 

# Q!{/ 

# 61£

METHOD OF SUPPORT 

### FORMULATORS EXEMPTION CITE-ALL .[ 

### NOT SUBMITTED [ SELECTIVE N/A 

### SUBMITTED N/A 

### REVIEW(Sj REQUESTED DATA PACK # DATE SENT 

### CHEMISTRY _________l [ ____ _ EFFICACY ________l [____ _ ACUTE TOX.______ l [____ _ RASSB TOX.___**~** __ l [____ _ 

### ENVIRON. FATE ________l [____ _ FISH/WILDLIFE ________l [____ _ OTHER,______ ,-__l [____ _ 

### I [ 1 [ 1 [ 1 [ 1 [ 1 [ ) [ DUE 

### DATE 1 NOT SUBMITTED

DATE RETURNED 

### 1 [ 1 [ ][ 

### 1 [ 1 [ 1 [ J[ 

### STATUS________**~** 

### _____**~-------------------**



## SCIENCE GROUP RESPONSE CODE 

# / I

# loSDIVISION BRANCH RESPONSE DATE



## SECTION CSF 

## YIN LABEL 

## YIN CHEMISTRY___**~AD~** 

## ______**~EAaS~S~B~_~C~T~TL_** 

## _______ _ EFFICACY ___**~AD~** 

## ______**~E~A~S~SQB** 

## __**~E~E~TL_** 

## ________ _

II

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460

DPBARCODE: MRID: SUBJECT: REG, NO, OR FILE SYMBOL: DOCUMENT TYPE: 

### Manufacturing-use [ ] OR INGREDIENTS (PC Codes): CAS Number: TEST LAB: SUBMITTER: GUIDELINE: COMMODITIES: REVIEWER: ORGANIZATION: APPROVER: APPROVED DATE: COMMENT: May 23, 2008 D351794 47391801 

### AR Granules 81293-I 

### Product Chemistry Review End-use Product [Xl 025601 1317-39-1 N/A 

### Cantox U.S.. Inc. NlA 

### Formulation Chris Jiang 

# C-.-J AD 

### Karen P. Hicks OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460

May 23, 2008 

### MEMORANDUM SUbject: From:

Thru: Review for 81293-1 Chris Jiang, Chemist Chemistry and Toxicology Team Product Science Branch Antimicrobials Division (75lOP) Karen P. Hicks, CT Team Leader Chemistry and Toxicology Team Product Science Branch Antimicrobials Division (75 IOP) 

### Thru: Michele E. Wingfield, Chief Product Science Branch Antimicrobials Division (751 OP) 

### To: Marshall Swindell PM 33\Karen Leavy Regulatory Management Branch 1 Antimicrobials Division (75 lOP) 

### Applicant: 

### Cantox U.S., lnc. Formulation from Label 

### Active lngredient(s) Cuprous oxide 

### Inert Ingredients Total % by wt. 

### 4.37% 95.93 

### % 

### 100.0 % OFfICt: OF !'REVEl1TION, PESTICIDES }I.ND TOXIC SUBST.1I.NCE$

### BACKGROUND: The registrant has a product chemistry package in response to the review done under D341848. The package includes a label, a Confidential Statement ofFormula for the basic formulation, and MRID 47391801. The registrant has refined the manufacturing process. 

### FINDINGS: 1. The concentration ofthe active ingredient on the Confidential Statement of Formula (CSF dated Feb. 29, 2008) is consistent with the label declaration. This CSF supersedes all previous CSFs for the basic formulation. 

### 2. All ingredients are cleared for use in pesticidal products. 3.. The descriptions ofthe starting materials and the manufacturing\production\ formulation process are acceptable. 4. The discussion ofthe formation ofimpurities is acceptable. 5. All certified limits are acceptable. 6. The enforcement analytical method is acceptable as this method was accepted in the review that was done under D303513. 7. The color, physical state, and odor are acceptable as the product is a solid (black, grey, or brown) which may have a slightly oily odor. 8. The relative density is acceptable as it was determined to be 100.07 Ibs/fr. 9. The pH is acceptable as the product is not dispersible in water. 10. The oxidation/reduction potential is acceptable as no oxidation or reduction is expected in the final product. 11. The flammability is acceptable as tlte product is not an organic liquid. 12. The explodability is acceptable the product is not potentially explosive. 13. The storage stability is acceptable. 14. The viscosity is acceptable as the product is not a liquid. 15. The miscibility is acceptable as the product is not an emulsifiable liquid. 16. The corrosion characteristics are acceptable.

### 17. The dielectric breakdown voltage is acceptable 

### as the product is not to be used around electrical equipment. 18. Per Label Review Manual, the percentage ofmetallic coppermust be declared as 3.88% as a footnote belowthe ingredient statement. 

### CONCLUSIONS: Product Science Branch ofAntimicrobials Division finds the submissions for 81293-1 to be acceptable, pending the label change which can be done on the next printing ofthe label.

## DATA PACKAGE BEAN SHEET Date: 22-Apr-2008 Page t of2 

### * 

## * * Registration Information 

## * * * Decision 

### #: 380723 DP 

### #: (351794) PRIA 

### Parent DP 

### #: Submission 

### #: 827088 Registration: 

### 81293-1
- AR GRANULES (ALGAE-RESISTANT ROOFING GRANULES) 

# d-**Ri'kC~~:,:: :~:::~:::~~~:O;~~C(703)308_634t** Room'PY1S-8 mf2vu))tJ <I

# ~ Risk Manager Reviewer: "K",",,':.c0-'L,,"'"'''Y'LCK'''LEA=VY'-'- ________ 

## --!'______ 

## ->\

## ~'fC-/ Sent Date: 04-Apr-2008 Calculated Due Oat : 30-Mar-200B Edited Due Date:**-=~"'5""~,** Type of Registration: Product Registration
- Section 3

# ~~::d~::':**~:~o:M:o:::::::,::~AST**TRACK,

# ..___-~~~_-=__ _ ...

# f-j!~~/~r * * * Data Package Information 

## ** * Expedite: • Yes 

## 0 No Date Sent: 22-Apr-2008 Due Back: ____ _ DP Ingredient: 025601, Cuprous ox'ide
DPTitie: __________________________ _ CSF Included: • Yes 

## 0 No Label Included: • Yes 

## 0 No Parent DP #:

Assigned To Date In Date Out Organization: "A"-D,,I

# '-PS.,8'--______ _ _ ____ Last Possible Science Due Date: 3Q-May-2008 Team Name: 

### "CTT.c;..Tf-__**~~--­** 

# R,,;,WBcN,m, 

# CEW r 

# 6

Contractor Name.

# --'L=-<'Sl~,,---~=----- * * * 

### Studies Sentfor Review * * * No Studies Science Due Date: ·ta-May-20GSSub Data Package Due Date: t3-May-2008 

# 7/d

# /.0J

* * * 

### Additional Data Package for this Decision * * * Printed on Page 2 

### * * * 

### Data Package Instructions 

## * * *

### Pages 37 through 38 contain Product Confidential Statement of Formula and are not included in this copy.FOrni Approved OMB No 2070-0060**~**

# .... UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

### ~~l

## ~ 401 M Street, S.W. WASHINGTON, D.C. 20460 PaperworkRMb:tionAct Notk:r. Thepublie reporting burden for this coIleeOOn ofinformation Is esfim.ted 10 average I hour pw response for**~** ac:fMties end f hoI.rperresp;mse for/1I!lIIgbtrItio andspecWmIewaetMIIe&, including lime for reading the mtrucllonl:and completing thenecessaryforms. Send comments regarding burden OGtimate or any otheriI5pOCt ofthis coIection ofinlonnation, inclUding $Uggeet\onG for reducing tho burden to: Director,**OP:!i~formation** MIongaemeni 0M5i0n {2f37}, U.S. EnVifOllmental Protection Agency, 401 M Street. SW., Washington, DC 20460. 00 not send the com edform 10 Ihis address. SUMMARY OFTHEPHYSICAUCHE CAL PROPERTIES_(!')tNotke 98-1) I. PRODUCT NAME: 

### ARGranules 1. Reg. No.B1293-1
3. COMPANY NAME: 

### IKO Industries limited 4. SUBMISSION DATE: 29 February2008 I
5. PIRST

### SUBMI~AA 

### 0 7. PESTICIDE TYPE: 

### Antimicrobial 10. REGJSl'RA1l0N 

## [lEi Ii. RESUBMlSSlON 

### x 8. FORMULATED MANUFAcnJRlNG-USIi. PRODUCT 0 or 9. ENl).VSE PRODUCT 

### fX1 U. REREGISI'RATION 

### rD 13. PRODUCT MANAGER OR CHEMICAL REVIEW MANAGER '/NAME (IF KNOWN): U. REREG CASE'

14. GUIDELINE REFERENCE 15. VALUEor QUAUTAllVE**D~~ONIMETBOD(J)** USED 16. MRID or Ri"PORT NO. GroupB, Series 830-Pbysic::aland Chemical Properties (40 CFR. 158.190) -6302 Color Shades ofBlack, GreyorBrown NfA -6303 Pby,iCl.l StltO Solid NfA -6304 Cdo, May have a slightoilyodor NfA -631. OJdditionIRoducUon: All coating ingredients present are Vitrified. No oxidation or Chomicallnoompmtibility reduction potential is expected inthe final product. NfA -631' FLtflUllllbilityfFLtmo , £no,noon Not applicable. This productis not an organic nqu'ld NfA -631' ExplodJibility 

# I NlA Notapplicable. This product is not explodable. -6317 SlOnlo Stability This product consists ofandesIte rock encased in avitrified coating containing Cuprous oxide. The product is intended NfA for long-terlll outdoor useand is therefore highly stable. D -631' MUeib·lrrty I Notapplicable.This product is not a miscible liquid. NfA I -6320 Corroaioo Chlncterirlt;e. This productconsists ofandesite rock encased in a Vitrified coating containing Cuprous oxide. The product is intended for long-term outdoor useand is notexpected to corrode. 

# a NfA -6321. Dielectric BrMkdown Notapplicable.This product is not for use near elect.equip. NfA Volta I _7000 pH Notapplicable.This product is notdispersible in water. NfA -7100 Viscosity Notapplicable. This product is nota liquid. NfA _7300 DemityfRdllivll> Den.lityl 100.07 Ibs/squarefoot. SGS Lakefield Ref.NO.1171S-0011 lkIlk Denary EPA Form 8570-36 (07flANf1998) 15Form Approvod OMB No. 2070-0060 

# '"'"' UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

# (t l



# Il3- 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwoti(Rerb:tionAct Notice: fer Ihia collection ofinf«matlon is**lIS~maled** 10 average I hootper I"ft$ponSil for regl$Ira[ion actMIies and .1 instructions and Cflmplet[ng Ille necessary forms. S,", I reduelng thebUrden 10: Dlrec;tor, 

## I OPPEl 

## , ("'n. U.S. , Agency, 401 M Street, : 

### '"

# . DC 20460. Do not send Ihe 

# ,.**:1P~N""""'1\** 1. PRODUCTNAME: AR Granules 2.1t(o&. No.81293-t
3. COMPANY NAME: IKO Industries Limited 4. 

# I:::**~D** 7. PESTICIDE 1'VPE: Antimicrobial to. REGISl"RATION 

### [lEI



# •• ro. •. 

# "" u. rn 13. PRODUCT MANAGER ORCHEMICAL REVIEWMANAGER '/NAME (IFKNOWN): 

### n. REREG CASE'

14. GUIDELINEREFERENCE IS. VALUE 16. MRID or REPORT NO. ChemicaJ (40CFR**~302** 

### eoO. N/A 

# ..,,, "".1
...**"'~** Sohd NlA


# ..,

# .. Odo• IMay have a slight oilyodor N/A -63"**~:~~odU~OO:** I I present are vitrified. No oxidation or I is expected inthe final product. N/A -631S Flimnwbiliry/Fl&m

.. ,Not. t I, oot '" orgao" hquld N/A I 

# " -6316 E><plodability INot. i 

# , is not N/A -6317 SIO...,.. Subility I ,of. r I I Cuprous oXi.de. Th 

# " I 

# " NtA
·6319 Miacibi[ity 

### I Not applicable.This product is not a miscible liquid. N/A i 

# ..,,, Com>oioo**Ch.oradtrilli~'** i i i I 

# ". I

### '~:!**~uprous o~~~~.**  The

### prOdUj~~S,**intende~** N/A -6321**~~:m~** Bnoddown Not. h This product is not for use nearelect. equip. N/A ·1000 

## ,H INot applicable.This product is not dispersible in water. N/A .7[00**Vi~.itr** N01. h This 

## ,n, ',n IN/A .7300
. Denoityl tOO.07Ibs/square foot. SGS Lakefield _n



### .'.-W'

# iPA~998) 15

### -<,.. 

## 3' 

## "-

I

.)



# ) 

# ) F onn Approved. OMS N os. 2070-0060: 2070-0057; 2070-0t07**#'~.,s"'~** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

# (ez} 1200 Pennsylvania Avenue, N.W.

, ,<, WASHINGTON, D.C. 20460

.., PIlei\'<;' Paperwork. Reduction Act Notice: The public reporting burden for this collection ofinfonnation is estimated to average 0.25 hours per response for registration activities and 0.25 hours pel" response for reregistration and special review activities, includingtime for reading the instructions and completing the necessary forms. Send comments regarding the burden estimateor any other aspect ofIhis collection ofinformation, including suggestions for reducing the burden to: Director, Collection Strategies Division (2822T), U.S. Envirorurental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, DC20460. Do not send the form to this address. 

## SELF-CERTIFICATION STATEMENT FOR THE PHYSICAL/CHEMICAL PROPERTIES (PRNOTICE 98-1) ProductName: 

### AR Granules Reg, No.lFile Symbol No, (ifknown) or Company No, 81293-1 

## SELF-CERTIFICATION STATEMENT: I certifythat the reported information on the "SummaryForm" represents a true and accurate record of the test results ofstudies generated orowned by (CompanyName): 

### IKO Industries, Ltd, and that the values ofthe properties reported are reliable. I further certifY that such data were generated in substantial conformity with OPPTS Test Guideline Series 830 Product Properties, applicable to my product, and in effect at the time ofsubmission. As a condition ofregistration, EPA may, by order, (1) 

### withdraw a pending registration, (2) suspend the registration ofthis product without opportunity for hearing, or(3) assess civil penalties provided for in section 14 ofFIFRA for violations ofsection 12(a)(2)(N) ofFIFRA without opportunity for hearing, ifI have not submitted to 

### EPAwithin thirty (30) days ofreceipt ofa request by the Agency, orwithin a specified time agreed to bythe Agency, test results ofstudies summarized in the "Summary Form." As a condition ofregistration, EPA may, by order, (I) 

### withdraw a pending registration, (2) suspend the registration ofthis product without opportunity for hearing, or (3) assess civil penalties provided for in section 

### 14 ofFIFRA for violations ofsections 12(a)(2)(N), 12(a)(2)(Q), or 12(a)(2)(R) ofFIFRA without opportunity for hearing, ifI fail to provide to EPA within thirty (30) days ofreceipt ofa notification oferror, or within a specified time agreed to by the Agency, information that EPA determines is required to correct the error. Type Applicant's Name: Dr. Earle Nestmann 

### Title: President, Cantox U,S, Inc, Telephone No, 908-429-9202 Applicant's Signature:cS\·

# _~ Date: 29 February 2008 

# i\..L0..

# L~'

- EPA Fonn 8S70-)7 (t2 2003)
AtIJ.o:h_2

14UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

### 401 MStreet. S.W. WASHINGTON, D.C. 20460 'OMBNo

Paperworlt Reduction Act Notice: The public reporting burden for this collection ofinfOffilation is estimated 10 average 1.25 hours per response for registration and 0.25 hours per response for reregistrCltion and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding burden estimate or any other aspect ofthis collection ofinfoffilation, including suggestions fot reclucinglhe burden to: Director, OPPE Infoonation Management Division (2 f37), U.S. Environmental ProtectionAgency, 40t M Street, S.w., Washington, DC 20460. Do not send the fann 10 this address. 

### Certification with to Citation of Data Applicant'slRegistranfs Name. 10.01" U.S.**I~'.** lOll I Number •NJ 08807 EPA Registration Number/File Symbol Bt293-f Active InOfedient(s) and/or reDfesenlative test comoound(s) !Cuprous Oxide Dale
General Use Paltem(s) (fIst all those claimed fOf this product uslnq 40 CFR Part t58) Domestic Outdoor Product Name
NOTE: Ifyour product is a 100% repackaging ofanother P\.Ifchased EPA-registered product labeled for all the same uses on yourlabei, you do not needto submit this fotm. You must submit the Formulator's Exemption Statement (EPA Form 8570-27). 

# o I am responding to a Data..c;all-In Notice, and have included with this form a list ofcompanies sent offers ofcompensation (the Data Ma\riltform should be used for th'IS PUlpOse).
SECTION I: METHOD OF DATA SUPPORT (Check one method only)

. I am using the cite-all method ofsupport, and have included with this fotm a list ofcompanies sent offers ofcompensation (the Data Ma\rilt form should be used for this purpose). 

# o Iam using the selective method ofsupport (or cite-all option under the**se\ec~ve** method), and have included with this form a list ofdata requirements (the Data Ma\rilt form must be
SECTION II: GENERAL OFFER TO PAY [Required if using the cite-aD method Ofwhen using the cite-aH option under the selecHve method to satisfy one or more data requirementsl 

# EJ I hereby offerand agree to pay compensation, to other pe!'SOns, with regard 10 the approval ofthis application, to the extent required by FIFRA.

## ;,~, i 'I SECTION Itl: CERTIFICATION

1I, this;**~ !.all.?a~**  in files that (t) concern the properties or effects ofthis product Ofan Identical or one or more ofthe ingredients in this product: and (2) is a type ofdata that would be required to be submitted under the data date ofapproval of this application ifthe application sought the initial registration ofa product of idenllcal or similar composition and
Icertify that for each exclusive use study cited In support ofthis registration Of rereglslfation, that Iam the original data submitter or that I have obtained the written pelTllission ofthe OIiginal data submitter to cite that study. I .**~** f" study cijed In support ofthis registration Of reregistration that Is not an exclusive use study, either: (a) Iam lhe original data submitter; 

### .!.b)-i.i

. pennission ofthe original data submitterto use the stUdy in support ofthis application; (c) all periods ofeligibility for 

# I**:::"(~~~:;** have expired for the study: (d) the study is in the public literature; or (6) I have notified in writing the company that submitted the study and have (I) to pay compensation to the extent required by sections 3(cX tXF) and/or 3(c)(2XB) ofFIFRA; and (ii) to commence**negotia~ons** to det6mline the amount and t6mlS ofcompensation, ifany, to be paid for the use ofthe study. I certify that in all instances where an offer ofcompensation is required, copies ofall offero to pay compensation and evidence oftheir delivery in accordance with sections 3(c}( tXF) andlor 3(c)(2)(B) of FIFRA am available and will be submitted 10 the Agency upon request. Should Ifail to produce such evidence to the Agency upon request. I underntand that the Agency may Initiate action to deny, cancel or suspend the registration of my product in cornOlTTlity with FIFRA. I certifythatthe statamants I have made on this fonn and all attachmentsto " are lJ'ua, accurata, and comptate. I acknowr.dga that any knowlngCy false or misleading statement may be punishable by fine or Imprisonment or both unaorapplicable law. Signature 

## D.,. Typed orPrinted Name and Tille 29 Feb 2006 Earle Nestmann, Authorized U.S. Agent


# ,

# .,""Form AoE. ••ed. OMI No. 2070-0080. AlXrovlll EliC 'r" 5-31-98. Un!tM Stat
.. 

# '7J 

# oEPA Environmental Protection Agency W•• hlngton. DC 20460 

# Formulator's Exem!ltion Statement (40 CFR T 2.85) pplloent's N.un. end Addr

.., EPA Fif, SymbollRsgl,tretion NunWer Cantox U.S., Inc. 81293-1 t011 Route 22 Wesl, Suite 200 Product Heme Bridgewaler, NJ 08807 AR Granules (A1gae·Reslslant Roofing Granules) Ott, of Confldentiel Stet_nt of Fonnule (EPA Form 857()-4) June 25, 2007 As an authori:zed representative of the applicant for registration of the product identified above, I certify that:

(1) Thi. product contain. the following active ingrediends): Cuprous oxide:



### 121 Of these, each active ingredient listed in paragraph (4) is present solely as the result of the u.a of that active ingredient in the manufacturing, formulation or repackaging another product which contains that active Ingredient which i. registered under flFRA Section 3, is purchased by us from another producer, and is labeled for at lea.t each use for which my product is proposed to be labeled. 

### 131 Indicate by checking (A) or (B) below which paragraph applies: 

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

# D OR (8) The Confidential Statement of Formula ICSF) (EPA Form 8570·4) referenced above and on file with the EPA i. complete, current, and accurate and contains the information required on the current CSF. 

### 141 The following active ingredients in this product qualify for the formulator'. exemption. 

### Source Active Ingredl'nt Product Heme Rsglett,lion Humb,r Cuprous oxide



# Q

# ~'gnatur. (**J:~U** 

# __ /<-_ Name 

### and rrtle

## ~t. Earle Nestmann, Aulhorized U.S. Agent 

### £ (,-u..Ui.v 

## '-1 .") iH) 

### ·6 EPA Fonn .610-27 I"".

# ".S, 'J 'NtWb. EPA c

# ... Yellow· Appla.nt 009YUnited Stat,. 

# §Registration .f 

### Amendment Other 

## Environmental ProtBction Agency W••hington, DC 20480 

### Application for Pesticide
- Section I 1. Company/Product Number 2. EPA Product Maneger 3. Propoled CI
... iflcltion IKO Industries, Ltd. 

### I 61293·1 

# o None 

# o R

.. trictlld 4. ComplnylProduct (Name, 

### PM. AR Granules (Alaae-Resistant Roofina Granules) 5, Name and Addr

... of AppHclnt (Include ZIP Code) 6. Expedited Reveiw. In accordance with FIFRA Section 3(c){3) 

### Cantox U.S., Inc. (b)(i), my prodUct is similar or identical in composition and labeling 

### 1011 Route 22 West, Suite 200 to: 

### Bridgewater, NJ 08807 EPA Reg. No. 

# o ChIck ifmil ;$ • new .ddrU$ 

### Product Name 

### Section
- II 

# 0 Amendment
- Explain below. 

# U Fin. printed lab,l, in repIon
..to Agsnev letter dettld 

# 0 Re.ubmi••ion in r••pon•• to Agency letter deted 

# 0 -Me Too- Applicatian. 

# 0 Notlficetion· Explain below. 

# 0 Other' Explain b,low. 

### Explanation: Us, addition,1 pag"sl if nacI"'ty. (For Ilction I and Saction II.) A refinement in the manufacturing process for the AR Granules is proposed wherein As a result, the proportion ofthe other ingredients and the active ingredient will change. The new manufacturing process is p'ovided in Part 830.t650, and the formulant list providing the new levels ofactive and other ingredients present in the granules is

rovided in Part 830. t600. 

### Section
- III I 1. Metsrlel Th_ Produc1 Will

.. Pecksgad In: Child·Rllistllnt Packaging Unit Packaging Water Solubla Packaging 2. Type of Contlinar 

# [2jV" [2jV"

# ~ V"**~Mot.** .f No 

### .f No No Pfestic Gle

.. e 

### ClNtificlJtJon mud If RYee- No. par If RY,s- No. per Paper bulk bags (Fabric) Unit Packaging wgt. containsr Packs"" wgt container ,/ Other (Specifyl 

### 1M submitted I 3. location of Nit Contents Informetian

... Siz,'s) Retail Container 5. locetion of label DirectioM



# l!': Labsl 

# I I Container 1-2,20-45,100, and 300-500 tons 

# U On label 8. M,nner in Which labal is Affixed to Product

### ~UthOgr"'h 

# 0 0",
.. ./ Papert.ued Stene' ltd

### Section -IV 1. Contact Point (Complete ;fefT/$ directly b-'ow

### to, identmcelion ofindividu. to be cllnf.c/ed. ifneelUMY. toproCIU this applicetion.) 

# N_. Tide TelepnoM No. /Include Are, Cod,)

Earle Nestmann Authorized U.S. Agen1 (908) 429·9202 

### Certification 8. Date AppHcltion I certify that the 'tetements I have made on this form end all sttachmants thareto are true. eccurate and complete. Recalm I acknowladge that any knowlinQlty fal,e or misleading steternant mey b. puniehable by fine or imprisonment or 

### (Stamped' both under applicabls law

.

.

# ,. (::2;:;' ignlture

# ~~~J--, 3. lide 

## , Authorized U.S. Agent



## ....

# -
•• Typed Name 5.0ete Earle Nestmann 

### 29 February 

## 2008



## .. EPA FOIm 8670-1 'Aev. 3-941 Pr• ...,ou. edltlone ara obsol.te. Yelow
- AptiIIcMt Copy

# •

• TRANSMITIALDOCUMENTFOR IKO INDUSTRIES LTD • 

### 1. 

### Name and Address ofSubmitter: Submitter: IKO 

### Industries Ltd. 

### RR #1, P.O. Box 839, 105084 Highway 7 

### Madoc. Ontario, KOK 2KO Canada AuthorizedAgent: 

### Earle Nestmann, Cantox U.S. Inc. 1011 Route 22 West, Suite 200 Bridgewater, NJ 08807 

### USA 

### 2. Regulatory Action in Support ofWhicb this Package is Submitted: Registration amendment. 

### 3. nate ofSubmission: Feb 29, 2008 

### 4. Application Fee: The application fees for this registration have submitted in aprevious package. 

### S. Bibliography: 473918·00

Volume I: 

### Administrative Volume: Forms (8570-1 Application x 1copy, 8570-4 Confidential Statement ofFormula 

### x 2 copies, 8570-27 Formulator's Exemption x 1copy, 8570-34 Certification 

### with Respect to Citation ofData x 1copy, Data Matrix x 1 copy); Draft 

### Label x 5 copies; 47391801 Volume 2: Product Chemistry (Group A and Group B data: 

### 830.1550, 830.1600, 830.1620, 830.1650,830.1670,830.1700,830.1750,830.1800, 830.1900, 830.6202. 830. 6303. 830.6404,830.6314.830.6315,830.6316.830.6317, 830.6319. 830.6320. 830.6321, 830.7000.830.7100,830.7300)

Company Name: IKO Industries Ltd. Company Contact: Earle Nestmann Tel: (908) 429·9202February 29, 2008
Mr. Marshall Swindell (PM 33) Environmental Protection Agency Office of Pesticide Programs One Potomac Yard 2777 South Crystal Drive 

### Arlington, VA 

## 22202 Mail Code: 7510P Dear Mr. Swindell: RE:**81293~1** 

### AR Granules Amendment 2008 

# CANTOX
HEALTH SCIENCES INTERNATIONAL

1011 Route 22 West Bridgewater New Jersey 08807 USA Phone: 908429·9202 Fax: 908-429·9260

Acting on behalf of IKO Industries, I have encJosed the foUowing items to clarify the proposed amendment to Registration No. 81293-1, AR Granules:

• Administrative Volume containing the relevant forms;

• Group A Data Chemistry data pertaining to Product Identity, Composition, and Analysis (Description of materials used to produce the product, description of the production process, description of the formulation process, discussion of the formation of impurities, preliminary analysis, certified limits, enforcement analytical method, and submittal of samples);

• Group 

### B Chemistry data pertaining to Physical and Chemical Properties Based on discussions with Mr. Edwards and Mr. Swindell of the Antimicrobials Division within the U.S. 

### EPA, it was agreed that the proposed change would be handled as an amendment on the basis that the changes proposed will not result in any revisions to the toxicity category or directions of use. I trust that the enclosed package will fulfill the outstanding data requirements and facilitate the evaluation the amendment submission. Ifyou have any questions or require further clarification, please do not hesitate to contact me. Kindest Regards,

Dr. Earle Nestmann Cantox Health Sciences
Encls.

Mississauga, ON Canada 

# • Bridgewater, NJ 

## USA 

# • Fleet, HANTS 

### UK , ,,(
" ( , ,

,



# • ShirljU'K'u, Tokyo 

### ,J!J'AN

" 

### ,

### TRANSMITTAL DOCUMENT FORIKO INDUSTRIES LTD. 1. 

### Name and Address ofSubmitter: Submitter: IKO Industries Ltd. 

### RR #1, 

### P.O. Box 839, 105084 Highway 7 Madoc, Ontario, KQK 

### 2KO Canada 

### Authorized Agent: EarleNestmann, Carrtox U.S. Inc. 1011 Route 22 West, Suite200 

### Bridgewater, NJ 08807 USA 

### 2. RegulatoryAction in Support ofWhich tbis Package is Submitted: Registration amendment. 

### 3. Date ofSubmission: Feb 29, 2008 

### 4. Application Fee: The application fees for this registration have submitted in a previouspackage. 

### 5. Bibliography: Volume 1:



### Reject (01) Volume 2: Administrative Volume: Fanns**(8570~1** 

### Application x I copy, 8570-4 Confidential Statement ofFormula x 2 copies,**8570~27** 

### Formulator's Exemption x 1 copy, 8570-34 Certification with Respect to Citation ofData x 1 copy, Data Matrix x 1 copy); Draft 

### Label x 5 copies; Product Chemistry (Group A and Group B data: 830.1550, 830.1600, 830.1620, 830.1650, 830.1670, 830.1700, 830.1750, 830.1800, 830.1900, 830.6202, 830, 6303, 830.6404, 830.6314, 830.6315, 830.6316, 830.6317, 830.6319, 830.6320, 830.6321, 830.7000, 830.7100, 830.7300)



### Company Name: IKO Industries Ltd. Company Contact: Earle Nestmann Tel: (908) 429-9202

### DECISION PKG. NO. SUBMISSION BAR CODE 

# #_X"J..LI-"d=(/£-,O"-LI_ SUBM. DUE DATE 

## (1//7' ,iF'? REVIEWER, __

# KD.~'L-=-- __

# ~._ CODING FORM FOR APPLICATIONS FOR REGISTRATION/AMENDMENTS

FILE SYMBOL/REG PM 

# .33
DESCRIPTOR ____________________ _ [ ] CHILD RESISTANT PACKAGING:

# PRIA~ FQPA_ NFQPA ___ ACTION CODE 

# 457

] REQUIRED NOT REQUIRED REGISTRATION TYPE: ] CONDITIONAL UNCONDITIONAL ] RESTRICTED USE DATE ON APPLICATION EPA RECEIVE DATE PM RECEIVE DATE 

# -.-LI**q:5~**

# / tJ:? 

# i/ I 

# ciJ.0 1.L2Z 

# 6 I 

# ;:j'i? /

# 0..2

METHOD OF SUPPORT FORMULATORS EXEMPTION CITE-ALL NOT SUBMITTED
REVIEW[S]**~**

# ~) EFFICACY ACUTE TOX. RASSB TOX. El'NIRON. FATE FISH/WILDLIFE OTHER: ] SELECTIVE ] N/A

DATA PACK 

### # J [ J [ [ [ 

### J [ J [ J [ J [ DATE SENT ] SUBMITTED ] N/A

DUE DATE 

### J [ J [ J [ J J J [ J [ J [ ] NOT SUBMITTED

DATE RETURNED 

### J [ 

### II II J [ J [ J [ J [

STATUS__________________________________________________________ __

RESPONSE CODE 

## --'..i-'.1...,\(>,,1) ___ _ RESPONSE DATE 

# & 

# 17ft!( 

# 1:

nq

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Washington, D.C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Antimicrobial Division



### October 18,2007 DP BARCODE: D341858 MRID: 47163901 SUBJECT: AR Granules REG. NO. OR FILE SYMBOL: 81293-1 DOCUMENT TYPE: Manufacturing-use [ J 

### OR INGREDIENTS (PC Codes): 025601 CAS Number: 1317-39-1 TEST LAB: SUBMITTER: Cantox U.S., Inc. GUIDELINE: COMMODITIES: REVIEWER: Chris Jiang APPROVER: Karen P. Hicks COMMENT: Product Chemistry Review End-use Product [Xl



### ORGANIZATION: AD APPROVED DATE: 

# /I!CJ (0+

### TO: Marshal1\Swindcll\Karen Leavy PM Team 33 FROM: 

### Chris Jiang. Chemist Product Science Branch. CT Team Antimicrobials Division (751 OP)**'-~~** 

# 9'

Karen P. Hicks, CT Team Leader·

# r'X
.../) l!.,

... f.·

..· .. ·

# c~{.-J Product Science Branch "/ / "'''-,- 

# J'" Antimicrobials Division (751 OP},--,/ " THRU:

THRU: 

### Michele E. Wingfield. Chief Product Science Branch Antimicrobials Division (751 OP) 

### APPLICANT: Cantox U.S., Inc. Action code : A57 

### Due out date: 11130/07

Product Formulation Active Ingrcdicnt(s): Cuprous oxidc % 

### bywt. 

### 6%

### BACKGROUND: The registrant has submitted a label, a Confidential Statement ofFonnula for the basic formulation, and MRID 47163901 in support ofthis amendment for a refined manufacturing process. The contractor has done the primary review ofthis submission and Product Science Branch ofAntimicrobials Division has done a secondary review which supersedes the primary review. 

### FINDINGS: 1. The concentration ofthe active ingredient on the Confidential Statement ofForn1111a 

### (CSF dated June 25, 2007) is inconsistent with the label declaration. 2. All ingredients are cleared for llse 

### in pesticidal products. 3. The CSF is unacceptable. (See confidential appendix) 4. The description ofthe starting materials is acceptable. 5. Because the CSF is unacceptable, the product identity and composition and the description ofthe manufachlring\production\fonnulation process are unacceptable. 6. The discussion ofthe formation ofimpurities is acceptable. 7. The certifIed limits are unacceptable as they cannot be calculated at the prescnt time. CONCLUSIONS: 1. Product Science Branch ofAntimicrobials Division finds the submission for 81293·1 to be unacceptable for the reasons indicated in the findings. The registrant needs to remedy the issues discussed in the findings.

### CONFIDENTIAL APPENDIX 1. The CSF is unacceptable. 

## Tn column 13a, the registrant writes and has numbers with no units. In addition, the registrant has values in column 13b which cannot be confirmed based on the entries in column 13a. The registrant is reminded to take the purity ofthe active ingredient into account when revising the eSF. 

### 2. Box 17 (the total weight) is left blank on the CSF and must be filled in.

### September 11, 2007
SUBJECT: PRODUCT CHEMISTRY REVIEW OF: ARGranules (AlgaeResistant Roofing Granules) 

### DP Barcode: [D341858]**Manufacturing~Use** 

### [X] Reg. No. or File Symbol: [81293-1] 

### End-Use Product [ ] TO:

FROM: THRU:

APPLICANT: Karen Hicks, Team Leader Product Science Branch EPAAntimicrobialsDivision 

# esc Systems & 

### Solutions LLC 

### Wallace Powell Product Science Branch EPA AntimicrobialsDivision 

### IKO Industries Ltd. Madoc, Ontario, Canada


### ProductFormulationActive Ingredient(s): 6/ 0 

### by Wt.: Cuprous oxide

.....................,...................................................... 4.6% 

### BACKGROUND: On behalfofIKO Industries Ltd., Cantox U.S., Inc. has submitted product chemistry data as part ofan amendment application forthe manufacturing-use product, ARGranules (AlgaeResistant Roofing Granules) (EPA Reg. No. 81293-1). This product is for use inmanufacturing roofing shingles. IKO Industries Ltd. intendsto employ a refined fonnulation process, which results in a lower active ingredient concentration (i.e., from 6% to 4.6%). The applicant provided a Confidential Statement ofFonnula (CSF) for the basic fonnulation (dated June 25, 2007). Theproductis produced by a non-integrated system. The registered product, Cuprous Oxide ), is the source ofthe active ingredient, cuprous oxide. 

### FINDINGS: Group A Requirements

- Product Chemistry (MRID 471639.01)

• Group A product chemistry 

### data requirements applicableto manufacturing-use products have beenmet, with the exception ofOPPTS 830.1600 (Descn ption ofMaterials) and



### Page I of7

### OPPTS 830.1650 (Formulation Process). Seethe "Recommendations" section ofthis report for deficiencies. See also Table A ofthis report. 

### Group B Requirements

• The datapackage did not include Group B physical and chemistryproperty information for the productproduced from the refined formulation process (Le., 4.6% active). Group B product chemistry data were likelypreviouslyprovidedto the Agency for the product containing 6% active. Based on informationprovided inthe datapackage, significant differences inthephysical and chemical properties ofthe two products are not expected. EPA maywantto confirm this, however, by evaluatingthe CSFs for bothproducts. 

### Confidential Statement ofFormula

• Certain information onthe CSF needs to berevised, as noted in the "Recommendations" section ofthis report. 

### Product Label

• Certain information on the last acceptedproduct label (datedNovember 12,2004) needs to berevised, as noted inthe "Recommendations" section ofthis report. The data package didnot include a proposed label. 

### RECOMMENDAnONS:

• To satisfY OPPTS 830.1600 (Description ofMaterials) requirements, the following inconsistency needs to be addressed: The supplier's address for cuprous oxide is identified as on the CSF and 

### as on the MSDS and in the study assigned MRID 471639-01.

• To satisfy OPPTS 830.1650 (FormulationProcess) requirements, the following informationmust beprovided: Clarification as to whetherthe paint ispreparedpriorto orduring application of the paint to the granules.

A description oftheproceduresused to assure consistent composition ofthe product (e.g., calibration ofequipment, sampling regimens, analytical methods, quality control measures), as requested under OPPTS 830.1650(b)(5).

Page 2 of7

### • The following changes to the CSF are recommended: Correctthe certified limits for

. It 

### is likely thatthe upper certified limit shouldbe identified as andthe lower certified limit should be identified as "

• The following changes to the last-acceptedproduct label (datedNovember 12,2004) are recommended: Change the concentration ofthe active ingredientto read "4.6%" and changethe inert ingredient concentrationto read "95.4%."


### PRODUCT CHEMISTRY REVIEW L 

### CONFIDENTIAL STATEMENT OF FORMULA
a. Type offormulation and source registration:

• Non-integrated formulation system [X)

• Are 

### all TGAIs used registered? Yes [ ) No [ )

• Integrated formulation system 

### [ )

• If"ME-TOO," specifyEPA Reg, No, ofexisting product: __ _ b. Clearance ofinerts for non-food or food use: Theproduct is cleared for food use under40 CFR §§180,940 and 180,950. Yes [ ) No[) 

### Note: Theproduct is not for food use.
c. Physical state of product: 

### Solid 

### (i. e., granule) d. The chemical IDs and analytical infonnation (including that for the TGAls), density, pH, and flammability are consistentwiththat given in 830 Series, Group B. Yes[) No[) 

### Note: The datapackage didnot include Group Bphysicalandchemistryproperty information. GroupBproductchemistry data were likelypreviouslyprovidedto theAgency_

Page 3 of7

### e. TheNCs and CLs are acceptable. 

### Note: See TableA of this report. f. Active ingredient(s) Cuprous oxide NC (%) 

### 4.6 Yes [ 

# 1

g. Forproducts produced by an integrated fonnulation system:

• Do all impurities oftoxicological significancehave a UCL? Yes [ 

### 1 No [ 

### 1 Not applicable 

### [Xl LCL (%) 

### 4.37

• Have all impurities**of~** 

### 0.1 % in the product been identified? Yes [ 

# 1 No [ 

# 1 Not applicable 

### [Xl II PRODUCT LABEL No 

### [X]

UCL 

### (%) 4.83

a. The active ingredient(s) statement (chemical IDs andNC) is consistent with the CONFIDENTIAL STATEMENT OF FORMULA. Yes [ 

## 1 No 

### [Xl 

### Note: Theproduct label needs to be revised, as notedin the "Recommendations" section of this report. b. The fonnula contains one ofthe following:

• 10% ormore ofa petroleum distillate: • 1.0% ormore ofmethyl alcohol: • sodiumnitrite at any level: • a toxic List I inert at any level: • arsenic in any fonn: Yes [ 

# 1 Yes [ 

# 1 Yes [ 

# 1 Yes [ 

# 1 Yes [ 

# 1 No 

### [X] No 

### [X] No 

### [Xl No 

### [Xl No 

### [Xl
c. If"yes" to any ofthe above. does the inert ingredients statement contain a footnote indicating this? Yes [ 

# 1 No [ 

# 1 Notapplicable 

# [Xl d. Appropriate warning statement(s) regarding flammability or explosive characteristics ofthe product are listed on the label. Yes [ 

# 1 No [ 

# 1 Notapplicable [ 

# 1 Note: The datapackage didnot include GroupBphysicalandchemistryproperly information. GroupBproductchemistry data were likelypreviouslyprovidedto theAgency.

Page 4 of7

### e. The storage and disposal instructions for the pesticide container are in compliance with PRNotice 84-1 for household use products orPRNotice 83-3 for all other uses. Yes [X] No [ ] f. 

### The product requires an expiration date at which timethe NC falls belowthe LeL (based onthe I-year storage stability data orother infonnation). Yes[] No[] Note: The datapackage didnot include Group Bphysicalandchemistryproperty information. Group Bproduct chemistry data were likelypreviously prOVidedto theAgency.


### Table 

### A: Product Chemistry (830 Series, Group A) Data Requirements Acceptance ofInformation 

### MRID No. 830.1550 Product Identity' A 471639·01 830.1600 Description ofMaterials U - MSDSs were provided for the starting 471639·01 materials. Infonnation identifyingthe supplier ofcuprous oxide is inconsistent, as follows:

- The supplier's address for cuprous oxide is identified as on the CSF and as onthe MSDS and inthe study assigned MRlD 471639·01. 830.1620 Production ProcessL 

### NA 830.1650 Fonnulation Process" U**~** 

### The process description does not identify 471639·01 whetherthe paint is preparedpriorto or during application ofthe paintto the granules. Theprocess description also does not identify

. A description ofthe procedures used to assure consistent composition ofthe product (e.g., calibration ofequipment, sampling regimens, analytical methods, quality control measures) was not provided, as requested under OPPTS 830.1650(b)(5). 830.1670 Formation of A 471639·01 Impurities 4 

### 830.1700 Preliminary Analysis Not required for products producedby a nonintegrated system. 830.1750 Certified Limits' A - Standard certified limits were proposed. 471639·01 A signed certification statement was provided. The upper and lower certified Page 5 of7

### Data Requirements Acceptance ofInformation MRIDNo. limits identified for onthe CSF are likely in error and need to be corrected. 830.1800 Analytical Method An enforcement analytical method was not provided inthe datapackage; however, it is likely that a method was previouslyprovided to the Agency. The active ingredient has not changed. 830.1900 Submittal ofSamples [Samples are to be provided on a case-by-case basis for manufacturing-use products.]



## . . ExplanatIon: A-acceptable; N-not acceptable (I.e., Item was submItted but IS not acceptable); NA=technicalIy not applicable (i.e., not required); G=datagap (i.e., item was not submitted but isrequired); U=requires upgrading (i.e., item is unacceptable but upgradeable); W=waived; E=EPA estimate. !See Confidential Appendix A for additional infonnation 2

### PorMPIEP products produced by an integrated fonnulation system. 3

### Porproducts from a TGAI orMP. 4

### May be waived unless actual/possible impurities are oftoxicological concern. 5

### Pive batch analysis required for productsproduced by an integrated fonnulation system. 6

### Ifdifferent from standard CLs reconamended in40 CFR 158.175, this should be discussed inConfidential Appendix A. 7

### Abbreviatemethod used as follows: gas chromatography (GC). infrared (IR), ultraviolet absorption 

### (UV). nuclear magnetic resonance (NMR), etc.
Table B: Physical and Chemical Characteristics (Series 830, Group B) Physical/Chemical Acceptance Value or Qualitative Description MRIDNo. Properties* ofData Group B product chemistry data were likely previously provided to the Agency. 830.6302 Color 830.6303 Physical State 830.6304 Odor 830.6313 Stabilityto Normal NA Notrequired for manufacturing-use and Elevated Temperatures, products. Metals, and Metal Ions 830.6314 Oxidation! Reduction; Chemical Incompatibility 830.6315 Flammability! Flame Extension 830.6316 Explodability
Page 6 of7

### Physical/Chemical Acceptance Value or QualitativeDescription 

### MRIDNo. Propcrties* ofData 830.6317 Storage Stability 830.6319 Miscibility 830.6320 Corrosion Characteristics 830.6321 Dielectric. NA Notrequired for manufacturing-use Breakdown Voltage 

## I products. 830.7000 pH' 830.7050 UVNisible NA Not required for manufacturing-use Absorption 

## I products. 830.7100 Viscosity 830.7200 Melting NA Notrequired for manufacturing-use PointIMelting Range 

## Iproducts. 830.7220 Boiling NA Notrequired for manufacturing-use PointIBoiling Range 

## I products. 830.7300 DensitylRelative Density/Bulk Density 830.7370 Dissociation NA Not required for manufacturing-use Constants in Water products. 830.7550/830.7560/830.7570 NA Notrequired for manufacturing-use Partition Coefficient 

## Iproducts. 830.7840/830.7860 Water NA Not required for manufacturing-use Solubility products. 830.7950 Vapor Pressure NA Not required for manufacturing-use 

## I products.



## . . . ExplanatIOn: A-acceptable; N-not acceptable (I.e., Item was submIttedbut IS not acceptable); NA=technicallynot applicable (i.e., not required); G=data gap (i.e., item was not submitted but is required); U=requires upgrading (i.e., item is unacceptable but upgradeable); W=waived; E=EPA estimate. 

# * Provide briefdescription, e.g., color

- yellow orproperty value, e.g., density 1.25 glee. Unless otherwise indicated, the property should be at 

### 25°C. IIfproduct is an emulsifiable liquid 2

### Ifproduct is dispersible with water

Page 7 of7

## DATA PACKAGE BEAN SHEET Date:**24~Jul·2007** Page tal t 

## * 

## * * Registration Information 

### * 

## * * Decision #: 380723 DP #: 

### (341858) PRIA Parent DP#:
Registration: 81293-1
- AR GRANULES (ALGAE-RESISTANT ROOFING GRANULES) Company: 81293
- CANTOX U.S., INC. Risk Manager: AM 33
- Marshall Swindell- (703) 308-634t Room# PY1 3-8828 Risk Manager Reviewer:**"K;ac~'""~L=,~a~"Y~K"L=E=A~VY,,-** _______________ _ Sent Dale: ____ _ Calculated Due Date: t4-Nov-2007 Edited Due Date: ____ _ Type of Registration: Product Registration
- Section 3 Action Dese: (AS7) AMENDMENT;NON-FAST TRACK;

Ingredients: 025601, Cuprous oxide(6%) 

## * * * Data Package Information 

### * 

## * * Expedite: ':::/ Yes. No Date Sent: 24-Jul-2007 Due Back: ____ _ DP Ingredient: 025601, Cuprous oxide

DP Tille: Granules Amendment 2007 CSF Included: • 

# Yes:.: No Label Included: • Yes**~ ~**  No Parent DP #:

Assigned To Date In Date Out Organization:**OA~D~/~P~S~B,-** ______ _ Team Name:**,C~TT';;-c-L--c-:------­** Reviewer Name:

# --CJ~~_~I_z".L.----- _____ Last Possible Science Due Date: t5-0ct-2007 Science Due Date: 

# /LJva/o 7**~** }
Contractor Name:

### .J..f!.~~,L~c!. 

# _______ _ * * * Studies Sent for Review 

## * * * No Studies Sub Data Package Due Date: 

### /?/&:rio

## 7 I 

### "7



## * * * Additional Data Package for this Decision 

## * * * No Additional Data Packages 

## * ** Data Package Instructions 

## ** 

## * Please review the enclosed attachment to support this amendment.MRID #47t639-0t and the CSFF

PRIA Action code 857 due date t 1/14/07 CIT due date is 10/t4/07

### Pages 61 through 62 contain Product Confidential Statement of Formula and are not included in this copy.

### INDUSTRIES LTD.

AR GRANULES**(ALGAE~RESISTANT** ROOFING GRANULES) FOR CONTROL OFALGAE IN ROOFING SHINGLES ACTIVE INGREDIENT: CUPROUS OXlDE

...........4.37%



## CAUTION INERT INGREDIENTS
.....95.40"/" 1'OTAL................•.....• 100.0"/" EPA Reg. No. 81293-1 EPA ES1. No. 08I352-CAN..IJOI Net Contcms: 2 tons

KEEP OUT OF REACH OF ClflLDREN PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS Harmful ifswa!Iowcd. Wash thoroughly wilh soap and water afterhandling and before eating, drinking, chewing gum, or using lObacco. FIRSTAID: Ifswa!Iowed: -Cal! a poison Control Center or doclOr immcdiale!y for lrcatmCnl ad\'icc. -Haw person sip a glass OfW3.1Cr ifable 10 swaHow. -Do not induce vomiling unless wid so by a Poison Control Ccnter or doc)Or. ·Do not give anY1hing by mouth 10 an unconscious person. DIRECTIONS FOR USE It is a violation ofFedera! Law)O use 1his produc1 in a manner inconsis1em wilh ils !abeling. Ifgrallu!es are to be slared prior 10 and during use, a copy Of1his label**mU~l** bc readily accessible to employees when thcy are ill 1hcir work area. For use in 1he manufaclUre ofroofing shingles. AR Granules should be mixl:d wilh slandard rooting granules al a rate uf2·10% byweigh1 and processed nonnaUy during manufacture ofthe shingles. For app!icalions whcre algae grow1h is severe. uniformly blend Wi1h standard roofinggranules al a ratc nOl to excced 20% by wcight. STORAGE AND DISPOSAL Do 1I0t contumillalo.: Wall')", food, or fced by storage or disposal. Pesticidc Storagc: Store undo.:r ambiem conditions. Pcs1icide Disposal: Was1es resulling from 1he use ofthis product may be disposcd 1)fon SilC or Ul an approved waSle disposal faci!ily. COD)uincr Disposal: Railcars and 1tueks

- eomplClciy emp1Y comaincr inlo applica1ion equipmelll and 1horoughly dean prior to refilling. Paper and plasticbags

- completely emply bag imo appliemion equipmell1. Do not reuse bag. Dispose ofClllply bag in a sanilary landfil!, orby incineration, or ifaUowed by stale and local aUlhorities, by burning. !fburned, stay OU1 ofsmoke. ManufaClUrcd by !KO Industries Lld. R.R.#!, P.O. Box 839 105084 HW#7 Madoc, Omario. Canada KOK2KO

# '~<- __________________________________________

# ~~~~ __

# ~F~O""~~A~PPP~'~O'~'~d~.~OM~B~N~o~.~20~7~O~~~'~O~.~A~pp,,~ov~.~E'~"i'~ ••

# ~5.~3~1.~'::;'. r United Stat
..



# &EPA

Applicant', Namo and Address

Canlox U.S., Inc. 1011 Roule 22 Wesl, Suile 200 Bridgewaler, NJ 08807 

### Environmental Protection Agency Wuhlngton, DC 20460 

## Formulator's Exemption Statement (40 CFR 152.85) EPA File Symbol/Ragiltration Numilor 81293-1 Ptoduct Name AR Granules (Algae-Resislanl Roofing Granules) Data of Confidential Statement of Formula (EPA Form 8570-4) June 25, 2007 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:

(2) Of these, each active ingredient listed in paragraph 14) 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 {AI or (BI below which paragraph applies:

### ~ (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 active ingredient(s) listed in paragraph (1). 

### OR 

# o (B) The Confidential Statement of Formula ICSF) (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. (4) The following active ingredients in this product qualify for the formulator's exemption.

Aotiv. Ingr&dient Cuprous oxide

EPA Form 857()"27 lR.v

.......95} 

## * U.S-GPO: IK6-3IIG-nO/20-4t3 

### Source Product Nome

Name and Title Eatle Nestmann, AUlhorized u.s. Agenl 

### Datel**~"2.-:S~1** White· EPA copy Yellow
- Applicant copy 

# IForm Approved OMB No. 2070-0060 .'-;';.', UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

# \s) 401 M Street, S.W• 

### ....

## _." WASHINGTON, D.C. 

### 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 1.25 hours per response for regislration and 0.25 hours per response for reregistration and special review acHvilies, including lime for reading the inslructions and completing the necessary forms. Send commenls regarding burden estimate or any other aspect ofthis collection of information. including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 40t M Street, SW., Washington, DC 20460. Do not send the completed form to this address. Certification with Respect to Citation of Data Applicant'slReo:;istranl's Name, Address, and Telephone Number EPA Reqistration Number/File Symbol Cantox U.S. Inc. 10fl Route 22 West, Suae 200, Bridgewater, NJ 08807 81293-1 Active Inoredientlsl and/or reoresentative test comPQundls) Date Cuprous Oxide June 25, 2007 General Use Pattem(s) (list all those claimed for this product usino:; 40 CFR Part 158) Product Name Domestic Outdoor AR Granules NOTE: Ifyour product is a tOO% repackaging of another purchased EPA-registered product labeled for all the same uses on your label, you do not need to submit this form. You must sUbmit the FOnTlulator's Exemption Statement (EPA Form 8570-27). 

# 0 I am responding to a Data-Call-In Notice, and have included with this fOnTl a list ofcompanies sent offers of compensation (the Data Matrix form should be used for this purpose).
SECTION t: METHOD OF DATA SUPPORT (Check one method only) 

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

# 0 I am using the selective method of support (or cite-all option a list of companies sent offers of compensation (the Data Matrix form under the selective method), and have included with this form a Should be used for this purpose). completed list ofdata requirements (the Data Matrix fonTl must be used). SECTION II: GENERAL OFFER TO PAY IRequired if using the cite-all method orwhen using the cite-all option under the selective method to satisfy one or more data requirementsl 

# 0 I hereby offer and agree to pay compensation. to other persons, with regard to the approvat ofthis application, to the extent required by FIFRA.
SECTION III: CERTIFICATION I certify that this application for registration, this form for reregistration, orthis Data-Call-In response is supported by all data submitted or cited in the application for registration, the form for reregistration. orthe Data-Call-In response. In addition, n' the cite-all option or cite-all option under the selective method is indicated in Section I, this application is supported by all data in the Agency's files that (1) concern the properties or effects ofthis product or an identical or substantially similar product, orone or more ofthe ingredients in this product; and (2) is a type of data that would be required to be submitted under the data requirements in effect on the date of approval ofthis application ifthe application sought the initiat registration of a product of identical orsimilar composition and uses. I certify that for each exclusive use study cited in support ofthis registration or reregistration, that I am the onginal data SUbmitter or that I have obtained the written permission ofthe original data submitter to cite that study. I certify that for each study cited in support ofthis registration or reregistration that is not an exclusive use study, either: (a) t am th'l origin:;>1 data submitter; (b) I have obtained the permission ofthe original data submitter to use the study in support ofthis application; (c) all periods of eligil..it:t). fJr compensation have expired for the study; (d) the study is in the public literature; or (e) I have notified in writing the company that submitted the 'S'\.I'lr and have offered (I) to pay compensation to the extenl required by sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA: and (ii) to commence negotiations to' d'ltermillethe amount and terms ot compensation, n' any, to be paid forthe use otthe study. I certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation a,ld evidence oftt'elr,deIIV'lry in accordance with sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA are available and will be submitted to the Agency upon**requc~:**.. Ct.cJld Ifail 10 pMGuce such evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registratior ('f my produ-'i '17 conformity with FIFRA. t certify thatthe statements I have made on this form and a[l attachments to it are true, accurate, and comptete. I acknowledge that any knowingly false or misteading statement may be punishabte by fine or imprisonment or both under applicable law,
Si,",'e,"

# (~\" £.

# f!**~ ~**  Date Typed or Printed Name and Title June 25, 2007 Earle Nestmann. Authorized U.S. Agent

. . EPA Form 8570 34 (9 97) ElectroniC and Paper verSions available. Submit only Paper verSion

.51FormApprovedOMSNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY()401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includinglimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director.OPPEInformationManagementDivision(2137).U.S.EnYironmentalProtectionAgency,401MStreet.SW.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDaleJune25,2007EPARegNo.lFileSymbol8f293·1[PagelOf1Applicant'sIReaislrant'sName&AddressProductCantoxU.S.,Inc.,101fRoute22West.Suite200,Bridgewater,NJ08807.Contact:EarleNeslmann.PhDARGranulesIngredientCuprousOxideGuidelineReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStalusNole830.1550ProductidentityandcompositionIKOIndustriesLtd.OWN830.1600DescriptionofmaterialsusedtoproducetheproductIKOIndustrieslid.OWN830.1650DescriptionofformulationprocessIKOIndustries,lid.OWN830.f670DiscussionofformalionofimpuritiesIKOIndustriesltd.OWN830.f750CertifiedlimitsIKOIndustriesLtd.OWNI-----....Signature-0:NameandTitleDateG-K".;..--..r-EarteNestmann,AutholizedU.S.AgentJune25,2007EPAForm8570--35{g..97}ElectronfcandPaperversionsavailable.SubmitonlyPaperversion.AgencyInternalUseCopy

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460

May 23, 2008 MEMORANDUM Subject: Review for**81293~1** 

### From: Chris Jiang, Chemist 

### Chemistry and Toxicology Team Product Science Branch Antimicrobials Division (75lOP) 

### Thru: Karen P. Hicks, CT Team Leader 

### Chemistry and Toxicology Team Product Science Branch Antimicrobials Division (751OP) 

### Thru: Michele 

## E. Wingfield, Chief Product Science Branch Antimicrobials Division (751OP) 

### To: Marshal! Swindel! PM 33\Karen Leavy Regulatory Management Branch I Antimicrobials Division (751OP) 

### Applicant: Cantox U.S., Inc. Formulation from Label Active Ingredient(s) 

### Cuprous oxide Inert Ingredients 

### Total % bywt. 4.37% 

### 95.93 % 

### 100.0 % OFFICE OF PRBVENTION, PESTICIDES AND TOXIC SUBST!\NCES

### BACKGROUND: The registrant has a product chemistrypackage in response to thereview done underD341848. The package includes a label, a Confidential Statement ofFormula for the basic formulation, and MRID 47391801. The registrant has refined the manufacturingprocess. 

### FINDINGS: 1. The concentration ofthe active ingredient on the Confidential Statement of Formula (CSF dated Feb. 29, 2008) is consistent with the label declaration. This CSF supersedes all previous CSFs for thebasic formulation. 

### 2. All ingredients are cleared for use in pesticidal products. 3" The descriptions ofthe starting materials and the manufacturing\production \ formulation process are acceptable. 

### 4. The discussion ofthe formation ofimpurities is acceptable. 5. All certified limits are acceptable. 

### 6. The enforcement analytical method is acceptable as this method was accepted in the review that was done under D303513. 7. The color, physical state, and odor are acceptable as theproduct is a solid (black, grey, orbrown) which mayhave a slightly oily odor. 8. The relative density is acceptable as it was detennined to be IOO.07Ibs/rr. 9. ThepH is acceptable as the product is not dispersible in water. 10. The oxidation/reduction potential is acceptable as no oxidation orreduction is expected in the final product. II. The flammability is acceptable as theproduct is not an organic liquid. 12. The explodability is acceptable the product is not potentially explosive. 13. The storage stability is acceptable. 14. The viscosity is acceptable as theproduct is not a liquid. 15. Themiscibility is acceptable as theproduct is not an emulsifiable liquid. 16. The corrosion characteristics are acceptable.

### 17. The dielectric breakdown voltage is acceptable 

### as the product is not to be used around electrical equipment. 18. PerLabel Review Manual, the percentage ofmetallic copper must be declared as 3.88% as a footnote below the ingredient statement. 

### CONCLUSIONS: Product Science Branch ofAntimicrobials Division finds the submissions for 81293-1 to be acceptable, pending the label change which canbe done onthe next printing ofthe label.

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460

DPBARCODE: MRID: SUBJECT: REG. NO. OR FILE SYMBOL: DOCUMENTTYPE: Manufacturing-use [ ] 

### OR INGREDIENTS (PC Codes): CAS Number: TEST LAB: SUBMITTER: GUIDELINE: COMMODITIES: REVIEWER: ORGANIZATION: APPROVER: APPROVED DATE: COMMENT: May23, 2008 

### D351794 47391801 

### AR Granules 81293-1 

### Product Chemistry Review End-use Product [X] 025601 

### 1317-39·1 N/A 

### Cantox U.S., 

### Inc. N/A 

### Formulation Chris Jiang AD 

### Karen P. Hicks OFFICE OF**P[~EVEN'j'ION** , rESTICIDES AND 'rOXIe SUBSTJ:.NC'ES

# n._. r••d imtructiom

# on,.v.,... befo,. < 

# "**fo~.** Fonn A 

### ,- OMB N .207 I 2-28-95 

# I&EPA United Stetes 

# B Registration opp Identifier Number 

### Environmental Protection Agency Amendment 

# I Washington, DC 20460 

## Other Application for Pesticide
- Section I 

# II. Company/product Number 2. EPA Product Manager 3. Proposed Cle!l!lification



### 81293-1 

# PO] None 

# D Restricted 4. Company/Product lNama) 

### PM' AR Granules (Aloae-Resistant Roofino Granules) 

# 15. Name and Address ot Applicant /lncluda ZtP Code/ 6. Expedited Aeveiw. In accordance with FIFRA Section 3{c){3)



### Cantox U.S., Inc. (b){i), my product is similar or identical in composition and labeling 

### 11011 Route 

### 22 West, Suite 

### 200 to:



### Bridgewater, NJ 

### 08807 EPA Reg. No. 

# o Check ifthis is II new IIddrass Product Name 

# I Section

- II

0 Amendment
- Explein below. 

# U Final printed lebels in repsonse to Agency letter dated 

### 10 Resubmission in response to Agency letter dated 

## _ .. 

### 0 8Me T008 Application. 

### 0 Notification
- Explain balow. 

### 0 Other
- Explain below. 

# IExplanation: Usa additional pega{sl if nacassery. IFor saclian I and Saclion ILl 

# I I Section· III

1. Material Thla Praduc1 Will Be Packagad In: 

# I**Ch"R~t~::P"k'9'"'** Unit Packaging 

## iWeter Solubla Packeging 2. Type of Container

# ~Y" 

# 'ta Y
.. 

# CJ Mot" Plastic " No " No No Glass 

# 1

* CtHtification 

### mU$t If "Yes" No. per If 8Yes8 No. par Paper Unit Peckaging wgt. container Peckage wgt container V' Other (Specify) bulk baqs (fabric) 

### be 

### $ubmitted I 

# 13.**l~cation** of Net Contants Infonnation 4. Size{s) Retail Conteiner 5. location of label Directions

### ~ labal 

# U Container t-2, 20-45,100, and 300-500 tons 

# t:d On label 

# •• Manner in Which labal is Affixed to Product 

# l::J lithograph 

# 0 Other Paper Ptlued 

### t Stenci ad 

## I Section· IV

I. Contact Point /Completll itllms direcr/y btl/ow fur idl1nfffication ofindividual to b. contacttld, ifntlCtl$SlIry, to proCI1SS this aprltca,·ior./ 

# I Namo Title

## !T-'I!'J~~one No.llrclude Area Code) Earle Nestmann Authorized U.S, Agent 

# I (908) 429-92,')::: Certification 6. Oete Application 

### 1 I cartify that thll stataments I have madtl on this form and all 8ttllchments theralo arll true, accurate end CO'T'p'l't"J.**~acvi~** I acknowledge that IIny knowlingUy**fah~1I** or misllllKling stattlmant meV be punishable bV fine or imprisolVT1l1nt or (Stamped) both under applicllbie law. 12.signatl{'(' 3, TItllI 

# (\,Q,

# ¥C~l**,..J..~",,--~** 

# • AUlhorized U.S. Agent 

## • 

# 14. Typed Name \ 5. Oeta

Earle Nestmann 

### June 

### 25, 2007
fPA Form 8570-1 (Rav. 3-941 Prelllous edItions era absolete. 

## .. Yallew
- Applicarrt Copy

### June 25, 2007
Document Processing Desk (REGFEE) Office of Pesticide Programs U.S Environmental Protection Agency Room 266A, Crystal Mall #2 1921 

### Jefferson Davis 

### Hwy. Arlington, VA 22202-4501 Dear Sir or Madam: 

### RE: 81293·1 AR Granules Amendment 2007 

# CANTOX
HEALTH SCIENCES INTERNATIONAL



### ,,,,,,, 

### "

Acting on behalf of IKO Industries, I have enclosed the following items to amend Registration No. 81293-1, AR Granules:


### • Application for Registration Amendment Form (8570-1)
• Description of the refined formulation process. Please note that the chemicals used to manufacture the product have not changed, rather the relative amounts of the individual constituents in the final product.
Subsequently, a new guarantee of 

### 4.6% cuprous oxide is proposed for the fonnulation. Sincerely,

# ~J.L~ILuJ-.,,-~ Earle 

### R. Nestmann, Ph.D President
Encls.

Mississauga, ON Canada 

# • Bridgewater, NJ 

## USA 

# " Fleet, HANTS 

## UK

# - TRANSMITTAL DOCUMENT FOR IKO INDUSTRIES LTD. 

### 1. Name and Address ofSubmitter: 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 ofWhich this Package is Submitted: Registration amendment. 

### 3. Date ofSubmission: June 25, 2007 

### 4. Application Fee: The applicant believes that fee category AS7 ($4,000) applies to this application for registration since the action is an amendment for registration of

### an existing antimicrobial product,**non~fast** 

### track, for FIFRA section 2(mm) uses. 

### 5. Bibliography: Volume!:

Volume 2: Administrative Volume: Fonns**(8570~1** 

### Application x I copy, 8570-4 Confidential Statement ofFormula x 2 copies, 8570-27 Formulator's Exemption x I copy, 8570-34 Certification with Respect to Citation ofData x I copy); Draft Label x 5 copies; Product Chemistry (Guideline References 830.I550, 830. I600, 830.1650, 830.1670, 830.1750. 830.1800)

/ 

### Company Official: 

## t:6-- (\ L 

### Name Company Name: IKO Industries Ltd. Company Contact: Earle NestmalUl 

### Tel: (908) 429.9202

# IFee for Servicel 

# {812601iThis package includes the following 

# New Registration

, Amendment 

# " Stupies? Fee Waiver? \ 

# volpay 

# % Reduction: _ for Division 

# 'AD BPPD RD Risk Mgr. [][] Receipt No. 

# s-I 812601 

# F======i EPA File Symbol/Reg. No. I 

# 81293-1 

# Pin
-Punc h Date:

# ~I===6::::/2===6::::/2===0==0::::::7

# ==i [J 

# This item is NOT subject to FFS action. 

# ,--Action 

# eoae: 

# I Requested: 

# I AS7 Parent/Child Decisions:

, Granted: 

# I As7 \ 

# Amount Due: 

# $**~** 

# I**~J$O.~ I~**  

# ____________**~** 

# Inert Cleare,d for Int

# 7 nded, Use Reviewer: 

# WA/!u/{dLGo3ShL/ I' 

# ::::;= 7 Remarks: 

# Uncleared Inert in Product Date: 

# 1eP. 7/0 7

### June 25, 2007


### Document Processing Desk (REGFEE) Office of Pesticide Programs U.S Environmental Protection Agency Room 266A, Crystal Mall #2 

### 1921 Jefferson Davis 

### Hwy. Arlington, VA 22202-4501 

### Dear Sir or Madam: RE: 81293-1 AR Granules Amendment 2007 

# CANTOX
HEALTH SCIENCES IHTERNATIONAL



### Acting on behalf of [KO Industries, I have enclosed the following items to amend Registration No. 81293-1, AR Granules:

• Application for Registration Amendment Form (8570-1)



### • Description of the refined formulation process. Please note that the chemicals 

### used to manufacture the product have not changed, rather the relative amounts of the individual constituents in the final product.
Subsequently, a new guarantee of 4.6% cuprous oxide is proposed for the formulation. Sincerely,

# (~ \

# ~JL~(LJ-.-.,,--~ Earle 

### R. Nestmann, Ph.D President
Encis.

Mississauga, ON Canada 

# .. Bridgewater, NJ USA 

# .. Fleet, 

### HANTS UK 

### 471639-00

### TRANSMITTAL DOCUMENT FOR IKO INDUSTRIES LTO. 1. 

### Name llnd Address ofSubmitter: 

### Submitter: IKO Industries Ltd. RR #1, P.O. Box 839, 105084 Highway 7 Madoc, Ontario, 

### KOK 2KO Canada 

### Authorized Agent: Earle Nestmann, Camox U.S. Inc. 1011 Route 22 West, Suite 200 Bridgewater, NJ OS807 USA 

### 2. RegulatoryAction in SupportofWhich this Package is Submitted: Registration amendment. 

### 3. Date ofSubmission: June 25, 2007 

### 4. Application Fee: The applicant believes that fee categoryAS7 

### ($4,000) applies to this application for registration since the action is an amendment for registration ofan existing antimicrobial product, non-fast track, for FIFRA section 2(mm) uses. 

### 5. Bibliography: Volume I: 

### Administrative Volume: Fonns (8570-1 Application x 1 copy, 8570-4 Confidential Statement ofFonnula x 2 copies, 8570-27 Fonnulator's Exemption x 

### 1copy, 8570-34 Certification with Respect to Citation ofData x 1 

### copy); Draft 

### Label x 5 

### copies; 47163901 

### Volume 2: Product Chemistry (Guideline References 830.l550, 830.1600, 830.1650, 830.1670, 830.1750, 830.1800)

Company Official:

# 6~< \e....

# ,.Jes+v\'~~"" IA 

### Name CompanyName: lKO Industries Ltd. Company Contact: Earle Nestmarm Tel: (908) 429·9202

# ~L.l~~'_~- Signature

### Registration Query Results

Registration 

### #: 81293-1 

## Summary Information For Product Registration
- Section 3 

## 81293-1

Registration Name: AR GRANULES (ALGAE-RESISTANT ROOFING GRANULES) Company: Current Status: Restricted Use:

Organization: Team: 81293
- CANTQX U.S., INC. Actiye.
- .Conditionally**.R~gist~red.** (12-NQv:-:W04) No 

### Active Ingredients PC Code 

### CAS# Ingredient Name Percent Active 025601 1317-39-1 Cuprous oxide 6 Total Rows: 1
AD 

### I RMS1 Antimicrobials Division, Risk Management Team 33 Swindell, Marshall (703) 308-6341 Child Resistant Package: Signal Word: Physical Form: Pesticide Category: label Image: Caution Granular ALGAECIDE View Label Image 

## Inert Ingredients

EPA Home 

### I OPP:Horne 

### I SearCh I Help Last updated on February 4, 2004, Version 1.4 http://dcopptogaso1:7777lpls/prismtop



### http://prism.epa.gov/pls/prismlOp/OPLRCResulLri_detail Page 1of1



## 211112008

### Via Federal Express

Document Processing Desk Office ofPesticide Programs (7504P) U.S. Environmental Protection Agency Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, V A 22202-450 I 

### Thursday, February 07, 2008



### Re: Authorization to Discuss Confidential Business Matters with Bergeson & 

### Campbell. P.c.. and The Acta Group, 

### L.L.C. Dear Document Processing GUiceI': lKO Industries Ltd. (TKO) authorizes the U.S. Environmental Protection Agency (EPA) 

### to disCl1SS iniom1a1ion, including confidential business information, related to the current Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration for AR Granules, EPA 

### Registration No. 8139-1, as well as related future amendments, with representatives fi'0111 

### Bergeson & 

### CampbeUjp.C., and its consulting affiliate, The Acta Group, L.L.C. (Acta). If YOU/have any questions, please contact me at (905)

# 457~2880 ext. 3354, or Henry M. Jacoby, Afta, at (301) 865-9090. 

# '3 { I- 'f

# 3-/ Sincerely,

Annmeza Wong Manager, Conformance and Quality ASS11ra
..**l:~**

{OOOO1085.DOC) [960.06! I 

### 40 HANSEN ROAD SOUTH· BRAMPTON, ONTARIO L6W 3H4· TEL: (905) 457-2880· FAX: (905) 450-3620

### June 25, 2007


### Document Processing Desk {REGFEE) Office of Pesticide Programs U.S Environmental Protection Agency Room 266A, Crystal Mall #2 

### 1921 Jefferson 

### Davis Hwy. Arlington, VA 22202-4501 Dear Sir or Madam: RE: 81293-1 AR Granules Amendment 2007 

# CANTOX

HEALTH SCIENCES INTERNATIONAL



### Acting on behalf of IKO Industries, I have enclosed the following items to amend Registration No. 81293-1, AR Granules:

• Application for Registration Amendment Form (8570-1)

• Description of the refined formulation process. Please note that the chemicals used to manufacture the product have not changed, rather the relative amounts of the individual constituents in the final product.
Subsequently, a new guarantee of 

### 4.6% cuprous oxide is proposed for the formulation. Sincerely, 

# (l \

# ~**~iLul-.cCl-->----r-** Earle 

### R. Nestmann, Ph.D President
Encls.

Mississauga, ON 

### Canada 

# • Bridgewater, NJ USA 

# • Fleet, HANTS 

## UK 471639-00

# MEMORANDUM DATE: O'}/o,/D'"":} 

# TO: 

# --'--'i\'-'-'

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# Reg u Iato

# rv Manager FROM: Information Services Branch, ITRMD
Your receipt of this data submission is not an indication that MRIDs for the enclosed studies have been posted in OPPIN. We expect that it

# will be approximately 5 days from the above date before the study-level data is available in OPPIN. Ifyou have any questions about this process, please contact Teresa Downs (305-5363).

This is a: 

# IJ! fully accepted submission

. 

# o partially accepted submission 

# o rejected submission

};OTE TO REG. MGR. RE U?PI!"" STt)DY PROCESS"P'G REv.'1-16--06