EPA Registration No. 81293-1 

Volume No. 2 
1

, 

;, 

, 

! . 

I ' 

I 

i . 

I 

! 

, 

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Material to be added to a Mini-Jacket 

(in the case where an e-Jacket exists) , ' , 

Reg. No.' ~iZ~3:1' 

Send toSIG: checkbox ~" ,,' - . ' . . . - . . 

This material is: ,., 

~ stamped-accepted label " 

€'NewCSF '" ' ' 

€ Notification 

€ Final Printed Label 

€ other: _' --'-____ --'----'---.-..-----...._-

" 

Instructions: Attach this notice on top of the' 

i" ·-·----mater-ial.1t l11ustbeclipp~dall togetherJind 

, 

I 

, 

, th-ere-snouidbe-N0:ST-A;P"'EES in-the material. " _ . c 

Then give th~mat~rial with this cov~rsheet to 

staff in the Information Services Center (Room 

23(». " '.' ". ' ' , , 

. Current as of Y'I~dnesday. May 10. 2006 
2

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

Ms. Jessica Walsh, 

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 Registration Number 81293-1 

Your Amendment Dated April 4"', 2008 

EPA Received Date Apri14'h, 2008 

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

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, to revise the 

manufacturing process, is acceptable. 

The Confidential Statements ofFonnula dated February 29th, 2008, is consistent with the 

label declaration and is acceptable. 

At the next printing of the labeling, revise the label declaration to include the percentage of metallic copper of 3.88% as a footnote to appear below the ingredient statement. 

A stamped copy of the labeling is enclosed for your records. 

If you have any questions concerning this letter, please contact Karen M. Leavy at (703)-308-6237. 

Sincerely, 

Marshall Swindell 

Product Manager 33 

Regulatory Management Branch I 

Antimicrobial Division(7510P) 
3

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 if swallowed. Wash thoroughly with 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 of water 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 of Federal Law to use this product in a manner inconsistent with its labeling. 

If granules are to be stored prior to and during use, a copy of this label must be readily accessible 

to employees when they are in their work area. 
4

For use in the manufacture of roofing shingles. AR Granules should be mixed with standard 

roofing granules at a rate of 2-1 0% by weight and processed normally during manufacture of the 

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 of this product may be disposed of on site or 

at an approved waste disposal facility. 

Container Disposal: Railcars and trucks - completely empty container into application 

equipment and thoroughly clean prior to refilling. Paper and plastic bags 

- completely empty bag into application equipment. Do not reuse bag. 

Dispose of empty bag in a sanitary landfill, or by incineration, or if 

allowed by state and local authorities, by burning. If burned, stay out of 

smoke. 

Manufactured by IKO Industries Ltd. 

R.R.# 1, P.O. Box 839 

105084 HW#7 

Madoc, Ontario, Canada 

KOK2KO 

Un&r 1M Fgd~!al !~ .. ::tic'.dG F\lO~:;idd," '_-,<" ,',;....J,".t;:,.y~ &1 as 

ama:ld',,~~<: ._"',' .~:_ 

regJ."b:·F:~ -11. No. 

~I '[Q3-/ 
5

(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( 
6

~~--------

, 

Recommendation of Division 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-g rti.'S 11 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 of active ingl'edient at 4.37\~) instead of a cOllcentration nf 6 ~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 281

[', 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 1 iJ30107 ,\'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 ('om Wlt'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? 

,,-_.,,-_ .. _---

-+~-_l__.,---+_vt---_,__-----~---~---~~-- ~ .. 

Datc: 

l[-30 '0'7 

-\--\\--\',---"'=\#\----------'----- -J----

on 0:-' non I"agmlfurc: 
7

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/US E P AlUS@ 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 
8

Recommendation of Division Directors 

Negotiated Due Dates 

Decision#: 380723 I Registration#:81293-1 \ Petition #: I 

Fee Category: AS7 PRIA Decision Time Frame: 120days 

Submitted by: Karen Leavy Branch: RMBI I Date: 02121108 

Company: Cantox U.S., Inc. I 

Original Due Date: 03/30/2008 I Proposed New Due Date: 05/29/08 

Previous Negotiated Due Dates: NIA 

Is the "Fix" in-house? Yes Ilf not, date "Fix" expected: 

Issue (describe in detail): Cantox U.S., Inc. submitted an application which included a revised Confidential , 

Statement of Formula, labeling, a description ofthe refined formulation process to the Agency for review. 

Upon review of the submitted chemistry data/information, the revised Confidential Statement of Formula, 

labeling and description of the refined formulation process showed the concentration of active ingredient to 

be at 4.37% instead of 6%) when the product was originally registered with the Agency. It was determined 

that in order for Cantox to change the concentration of the active ingredient, a new set of product chemistry I 

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

Describe Interactions with Company (describe when contacted and company's response including response 

to previous negotiated due dates): On November 27th, 2007the company was contacted via e-mail concerning 

the chemistry deficiencies. She stated that the company will submit a new set of product chemistry data to 

support the change in concentration of active 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 request was 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 

Rationale for Proposed Due Date: The 90-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 CommentslDeficiency Type: 

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 I Disapprove: i 

If disapproved, action to be taken: I 

'\ , (1 

d ~ r\ , 

, \! ' , 

\ \ \ \ r ) ~ , OD or DOD Signature: ~'i Date: 

I Ii '"L 

[Jot II, \ i \ 7-0< I v,'lX /} 

'i \ ' )' 

\, V ; ; , \ 
9

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 of the 75*day letter for Cantox, Inc. The time extension 

request from the registrant is below. 

75 da}lletler for 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)542-1011 
10

jwalsh@cantox.com 

www.cantox.com 
11

Chris, 

.. 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." 

. If you 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. If you are not the intended recipient, please 

advise by return e-mail and delete immediately without reading or forwarding to others. 

*Manufacturing process information may be entitled to confidential treatment*

*Inert ingredient information may be entitled to confidential treatment*
12

Hi Karen; 

n Jessica Walsh" 

<jwalsh@cantox.com> 

01/24/200807:17 PM 

To Karen LeavyfDCfUSEPAlUS@EPA 

cc 

bee 

Subject RE: FW: IKG/US EPA 

0000000 0 00 00000 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 

To 
13

Hi 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 
14

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 
15

"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. 
16

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 
17

.. 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 greatly 
18

appreciated. 

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.com 
19

Hi 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 
20

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, Ontario 
21

L5N 2X7 

jwalsh@cantox.com 

www.cantox.com 
22

Hi 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 dossier that 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, 

Jesslca Walsh 

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 
23

"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. 
24

Jessica Walsh 

Toxicologist 

Cantox Health SCiences International 

2233 Argentia Road, Suite 308 

Mississauga, Ontario 

L5N 2X7 

jwalsh@cantox,com 

www.cantox.com 
25

"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 

Subject 
26

Dear 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.pdf 
27

Hello 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 any further 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 
28

.. 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" 
29

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. 

KML 
30

Calendar 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 I Categorize 

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 for the 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 chemistry data requirements. 

I Your Notes ...., 
31

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 
32

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 
33

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 (75 lOP) 

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$ 
34

BACKGROUND: 

The registrant has a product chemistry package in response to the review done 

under D341848. The package includes a label, a Confidential Statement of Formula for 

the basic formulation, and MRID 47391801. The registrant has refined the 

manufacturing process. 

FINDINGS: 

1. The concentration of the 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 of the starting materials and the manufacturing\production\ 

formulation process are acceptable. 

4. The discussion of the formation of impurities 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. 
35

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 of metallic copper must be declared as 

3.88% as a footnote below the ingredient statement. 

CONCLUSIONS: 

Product Science Branch of Antimicrobials Division finds the submissions for 

81293-1 to be acceptable, pending the label change which can be done on the next 

printing of the label. 
36

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'PY1 S-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 Sent for Review * * * 

No Studies 

Science Due Date: ·ta-May-20GSSub Data Package Due Date: t3-May-2008 7/d /.0 J 

* * * 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.
39

FOrni Approved OMB No 2070-0060 

~ .... UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ~~l 

~ 401 M Street, S.W. 

WASHINGTON, D.C. 20460 

ac:fMties 

PaperworkRMb:tion 

end f hoI.r per resp;mse 

Act Notk:r. 

for /1I!lIIgbtrItio 

The publie reporting 

and specW 

burden 

mIew 

for 

aetMIIe&, 

this coIleeOOn 

including 

of information 

lime for reading 

Is esfim.ted 

the mtrucllonl: 

10 average 

and 

I hour 

completing 

pw response 

the necessary 

for ~ 

forms. 

Send comments regarding burden OGtimate or any other iI5pOCt of this coIection of inlonnation, 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 ed form 10 Ihis address. 

SUMMARY OF THE PHYSICAUCHE CAL PROPERTIES_(!')t Notke 98-1) 

I. PRODUCT NAME: ARGranules 1. Reg. No.B1293-1 

3. COMPANY NAME: IKO Industries limited 4. SUBMISSION DATE: 

29 February 2008 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. VALUE or QUAUTAllVE D~~ONIMETBOD(J) USED 16. MRID or Ri"PORT NO. 

Group B, Series 830-Pbysic::aland Chemical Properties (40 CFR. 158.190) 

-6302 Color Shades of Black, Grey or Brown NfA 

-6303 Pby,iCl.l StltO Solid NfA 

-6304 Cdo, May have a slight oily odor NfA 

-631. OJdditionIRoducUon: All coating ingredients present are Vitrified. No oxidation or 

Chomicallnoompmtibility reduction potential is expected in the final product. NfA 

-631' FLtflUllllbility fFLtmo , 

£no,noon Not applicable. This product is not an organic nqu'ld NfA 

-631' ExplodJibility Not applicable. This product is not explodable. I NlA 

-6317 SlOnlo Stability This product consists of andesIte rock encased in a vitrified 

coating containing Cuprous oxide. The product is intended NfA for long-terlll outdoor use and is therefore highly stable. D 

-631' MUeib·lrrty I 

Not applicable. This product is not a miscible liquid. NfA I 

-6320 Corroaioo Chlncterirlt;e. This product consists of andesite rock encased in a Vitrified 

coating containing Cuprous oxide. The product is intended 

for long-term outdoor use and is not expected to corrode. a NfA 

-6321. Dielectric BrMkdown Not applicable. This product is not for use near elect. equip. NfA Volta I 

_7000 pH Not applicable. This product is not dispersible in water. NfA 

-7100 Viscosity Not applicable. This product is not a liquid. NfA 

_7300 DemityfRdllivll> Den.lityl 100.07 Ibs/square foot. SGS Lakefield Ref.NO.1171S-0011 lkIlk Denary 

EPA Form 8570-36 (07flANf1998) 

15 
40

Form Approvod OMB No. 2070-0060 

'"'"' UNITED STATES ENVIRONMENTAL PROTECTION AGENCY (t l Il3- 401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Paperwoti( Rerb:tion Act Notice: fer Ihia collection of inf«matlon is lIS~maled 10 average I hoot per I"ft$ponSil for regl$Ira[ion 

actMIies and .1 instructions and Cflmplet[ng Ille necessary forms. 

S,", I reduelng the bUrden 10: Dlrec;tor, I OPPEl , ("'n. U.S. , Agency, 401 M Street, : '" . DC 20460. Do not send Ihe 

,. :1P~N""""'1\ 

1. PRODUCT NAME: 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 OR CHEMICAL REVIEW MANAGER '/NAME (IF KNOWN): n. REREG CASE' 

14. GUIDELINE REFERENCE IS. VALUE 16. MRID or REPORT NO. 

ChemicaJ (40CFR 

~302 eoO. N/A 

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

.., .. Odo • I May have a slight oily odor N/A 

-63" ~:~~odU~OO: I I present are vitrified. No oxidation or 

I is expected in the 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 near elect. 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 
41

-<,.. 

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 of infonnation is estimated to average 0.25 hours per response 

for registration activities and 0.25 hours pel" response for reregistration and special review activities, including time for reading the instructions and 

completing the necessary forms. Send comments regarding the burden estimate or any other aspect of Ihis 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, DC 20460. Do not send the form to this address. 

SELF-CERTIFICATION STATEMENT FOR THE 

PHYSICAL/CHEMICAL PROPERTIES (PR NOTICE 98-1) 

Product Name: AR Granules 

Reg, No.lFile Symbol No, 

(if known) or Company No, 81293-1 

SELF-CERTIFICATION STATEMENT: 

I certify that the reported information on the "Summary Form" represents a true and accurate record of 

the test results of studies generated or owned by (Company Name): IKO Industries, Ltd, 

and that the values of the 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 of submission. 

As a condition of registration, EPA may, by order, (1) withdraw a pending registration, (2) suspend the 

registration of this product without opportunity for hearing, or (3) assess civil penalties provided for in section 

14 ofFIFRA for violations of section 12(a)(2)(N) of FIFRA without opportunity for hearing, ifI have not 

submitted to EPA within thirty (30) days of receipt of a request by the Agency, or within a specified time 

agreed to by the Agency, test results of studies summarized in the "Summary Form." 

As a condition of registration, EPA may, by order, (I) withdraw a pending registration, (2) suspend the 

registration of this product without opportunity for hearing, or (3) assess civil penalties provided for in section 

14 ofFIFRA for violations of sections 12(a)(2)(N), 12(a)(2)(Q), or 12(a)(2)(R) ofFIFRA without opportunity 

for hearing, if I fail to provide to EPA within thirty (30) days of receipt of a notification of error, 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 

14 
42

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street. S.W. 

WASHINGTON, D.C. 20460 

'OMBNo 

Paperworlt Reduction Act Notice: The public reporting burden for this collection of infOffilation 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 of this collection of infoffilation, including suggestions fot reclucinglhe burden to: Director, OPPE 

Infoonation Management Division (2 f37), U.S. Environmental Protection Agency, 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: If your product is a 100% repackaging of another P\.Ifchased EPA-registered product labeled for all the same uses on yourlabei, you do not need to 

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 of companies sent offers of compensation (the Data Ma\rilt form should 

be used for th'IS PUlpOse). 

SECTION I: METHOD OF DATA SUPPORT (Check one method only) . 

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

a list of companies sent offers of compensation (the Data Ma\rilt form 

should be used for this purpose). 

o I am using the selective method of support (or cite-all option 

under the se\ec~ve method), and have included with this form a 

list of data requirements (the Data Ma\rilt form must be 

SECTION II: GENERAL OFFER TO PAY 

[Required if using the cite-aD method Of when using the cite-aH option under the selecHve method to satisfy one or more data requirementsl 

EJ I hereby offer and agree to pay compensation, to other pe!'SOns, with regard 10 the approval of this application, to the extent required by FIFRA. 

;,~, 

i 'I 

SECTION Itl: CERTIFICATION 

1 I, this; ~ !.all.?a~ in files that (t) concern the properties or effects of this product Of an Identical or 

one or more of the ingredients in this product: and (2) is a type of data that would be required to be submitted under the data 

date of approval of this application if the application sought the initial registration of a product of idenllcal or similar composition and 

I certify that for each exclusive use study cited In support of this registration Of rereglslfation, that I am the original data submitter or that I have obtained 

the written pelTllission of the OIiginal data submitter to cite that study. 

I . ~ f" study cijed In support of this registration Of reregistration that Is not an exclusive use study, either: (a) I am lhe original data 

submitter; .!.b)-i.i . pennission of the original data submitter to use the stUdy in support of this application; (c) all periods of eligibility 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) of FIFRA; and (ii) to commence negotia~ons to det6mline the 

amount and t6mlS of compensation, if any, to be paid for the use of the study. 

I certify that in all instances where an offer of compensation is required, copies of all offero to pay compensation and evidence of their 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 I fail 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 certify that the statamants I have made on this fonn and all attachments to " 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 unaor applicable law. 

Signature D.,. Typed or Printed Name and Tille 

29 Feb 2006 Earle Nestmann, Authorized U.S. Agent 

, .,"" 
43

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 009Y *Product ingredient source information may be entitled to confidential treatment*
44

United 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 if mil ;$ • new .ddrU$ Product Name 

Section - II 

0 Amendment - Explain below. U Fin. printed lab,l, in rep Ion .. 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 of the 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 of active 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" ~ .f No .f No No 

V" ~Mot. Pfestic 

Gle .. 

e ClNtificlJtJon mud If RYee- No. par If RY,s- No. per Paper 

Unit Packaging wgt. bulk bags (Fabric) 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 of individu. to be cllnf.c/ed. if neelUMY. to proCIU 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 

*Manufacturing process information may be entitled to confidential treatment*
45

• 

• 

TRANSMITIAL DOCUMENT FOR IKO INDUSTRIES LTD • 

1. Name and Address of Submitter: 

Submitter: 

IKO Industries Ltd. 

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

Madoc. Ontario, KOK 2KO 

Canada 

Authorized Agent: 

Earle Nestmann, Cantox U.S. Inc. 

1011 Route 22 West, Suite 200 

Bridgewater, NJ 08807 

USA 

2. Regulatory Action in Support of Whicb this Package is Submitted: 

Registration amendment. 

3. nate of Submission: 

Feb 29, 2008 

4. Application Fee: 

The application fees for this registration have submitted in a previous package. 

S. Bibliography: 

473918·00 

Volume I: Administrative Volume: Forms (8570-1 Application x 1 copy, 8570-4 Confidential 

Statement of Formula x 2 copies, 8570-27 Formulator's Exemption x 1 copy, 8570-34 

Certification with Respect to Citation of Data x 1 copy, 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) 429·9202 
46

February 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. If you 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 " , 
47

TRANSMITTAL DOCUMENT FOR IKO INDUSTRIES LTD. 

1. Name and Address of Submitter: 

Submitter: 

IKO Industries Ltd. 

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

Madoc, Ontario, KQK 2KO 

Canada 

Authorized Agent: 

Earle Nestmann, Carrtox U.S. Inc. 

1011 Route 22 West, Suite 200 

Bridgewater, NJ 08807 

USA 

2. Regulatory Action in Support of Which tbis Package is Submitted: 

Registration amendment. 

3. Date of Submission: 

Feb 29, 2008 

4. Application Fee: 

The application fees for this registration have submitted in a previous package. 

5. Bibliography: 

Volume 1: 

Reject (01) Volume 2: 

Administrative Volume: Fanns (8570~1 Application x I copy, 8570-4 Confidential 

Statement of Formula x 2 copies, 8570~27 Formulator's Exemption x 1 copy, 8570-34 

Certification with Respect to Citation of Data 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 
48

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 
49

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+ 
50

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 Product Science Branch "/ ' / X "'''-,- ... J'" /) l!., ... f.· .. · .. · c~{.-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% 
51

BACKGROUND: 

The registrant has submitted a label, a Confidential Statement of Fonnula for the basic 

formulation, and MRID 47163901 in support of this amendment for a refined manufacturing 

process. The contractor has done the primary review of this submission and Product Science 

Branch of Antimicrobials Division has done a secondary review which supersedes the primary 

review. 

FINDINGS: 

1. The concentration of the active ingredient on the Confidential Statement of Forn1111a 

(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 of the starting materials is acceptable. 

5. Because the CSF is unacceptable, the product identity and composition and the 

description of the manufachlring\production\fonnulation process are unacceptable. 

6. The discussion of the formation of impurities is acceptable. 

7. The certifIed limits are unacceptable as they cannot be calculated at the prescnt time. 

CONCLUSIONS: 

1. Product Science Branch of Antimicrobials 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. 
52

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 of the 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. 

*Manufacturing process information may be entitled to confidential treatment*
53

September 11, 2007 

SUBJECT: PRODUCT CHEMISTRY REVIEW OF: AR Granules (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 

EPA Antimicrobials Division 

esc Systems & Solutions LLC 

Wallace Powell 

Product Science Branch 

EPA Antimicrobials Division 

IKO Industries Ltd. 

Madoc, Ontario, Canada 

Product Formulation Active Ingredient(s): 6/0 by Wt.: 

Cuprous oxide ..................... , ...................................................... 4.6% 

BACKGROUND: 

On behalf of IKO Industries Ltd., Cantox U.S., Inc. has submitted product chemistry data 

as part of an amendment application for the manufacturing-use product, AR Granules (AlgaeResistant Roofing Granules) (EPA Reg. No. 81293-1). This product is for use in manufacturing 

roofing shingles. IKO Industries Ltd. intends to 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 of Fonnula (CSF) for the basic fonnulation (dated June 25, 

2007). The product is produced by a non-integrated system. The registered product, Cuprous 

Oxide ), is the source of the active ingredient, cuprous 

oxide. 

FINDINGS: 

Group A Requirements - Product Chemistry (MRID 471639.01) 

• Group A product chemistry data requirements applicable to manufacturing-use products 

have been met, with the exception of OPPTS 830.1600 (Descn ption of Materials) and 

Page I of7 

*Product ingredient source information may be entitled to confidential treatment*
54

OPPTS 830.1650 (Formulation Process). See the "Recommendations" section of this 

report for deficiencies. See also Table A of this report. 

Group B Requirements 

• The data package did not include Group B physical and chemistry property information 

for the product produced from the refined formulation process (Le., 4.6% active). Group 

B product chemistry data were likely previously provided to the Agency for the product 

containing 6% active. Based on information provided in the data package, significant 

differences in the physical and chemical properties of the two products are not expected. 

EPA may want to confirm this, however, by evaluating the CSFs for both products. 

Confidential Statement of Formula 

• Certain information on the CSF needs to be revised, as noted in the "Recommendations" 

section of this report. 

Product Label 

• Certain information on the last accepted product label (dated November 12,2004) needs 

to be revised, as noted in the "Recommendations" section of this report. The data 

package did not include a proposed label. 

RECOMMENDA nONS: 

• To satisfY OPPTS 830.1600 (Description of Materials) 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 (Formulation Process) requirements, the following 

information must be provided: 

Clarification as to whether the paint is prepared prior to or during application of 

the paint to the granules. 

A description of the procedures used to assure consistent composition of the 

product (e.g., calibration of equipment, sampling regimens, analytical methods, 

quality control measures), as requested under OPPTS 830.1650(b)(5). 

Page 2 of7 *Product ingredient source information may be entitled to confidential treatment*

*Manufacturing process information may be entitled to confidential treatment*
55

• The following changes to the CSF are recommended: 

Correct the certified limits for . It is likely that the upper certified limit 

should be identified as and the lower certified limit should be identified 

as " 

• The following changes to the last-accepted product label (dated November 12,2004) are 

recommended: 

Change the concentration of the active ingredient to read "4.6%" and change the 

inert ingredient concentration to read "95.4%." 

PRODUCT CHEMISTRY REVIEW 

L CONFIDENTIAL STATEMENT OF FORMULA 

a. Type of formulation and source registration: 

• Non-integrated formulation system [X) 

• Are all TGAIs used registered? Yes [ ) No [ ) 

• Integrated formulation system [ ) 

• If "ME-TOO," specify EPA Reg, No, of existing product: __ _ 

b. Clearance of inerts for non-food or food use: 

The product is cleared for food use under 40 CFR §§180,940 and 180,950. 

Yes [ ) No[) 

Note: The product 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 consistent with that given in 830 Series, Group B. 

Yes[) No[) 

Note: The data package did not include Group B physical and chemistry property 

information. Group B product chemistry data were likely previously provided to 

the Agency_ 

Page 3 of7 

*Inert ingredient information may be entitled to confidential treatment*
56

e. The NCs and CLs are acceptable. 

Note: See Table A of this report. 

f. Active ingredient(s) 

Cuprous oxide 

NC 

(%) 

4.6 

Yes [ 1 

g. For products produced by an integrated fonnulation system: 

• Do all impurities of toxicological significance have 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 and NC) is consistent with the 

CONFIDENTIAL STATEMENT OF FORMULA. Yes [ 1 No [Xl 

Note: The product label needs to be revised, as noted in the "Recommendations" 

section of this report. 

b. The fonnula contains one of the following: 

• 10% or more of a petroleum distillate: 

• 1.0% or more of methyl alcohol: 

• sodium nitrite 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 of the above. does the inert ingredients statement contain a footnote 

indicating this? Yes [ 1 No [ 1 Not applicable [Xl 

d. Appropriate warning statement(s) regarding flammability or explosive characteristics 

of the product are listed on the label. 

Yes [ 1 No [ 1 Not applicable [ 1 

Note: The data package did not include Group B physical and chemistry properly 

information. Group B product chemistry data were likely previously provided to 

the Agency. 

Page 4 of7 
57

e. The storage and disposal instructions for the pesticide container are in compliance 

with PR Notice 84-1 for household use products or PR Notice 83-3 for all other uses. 

Yes [X] No [ ] 

f. The product requires an expiration date at which time the NC falls below the LeL 

(based on the I-year storage stability data or other infonnation). 

Yes[] No[] 

Note: The data package did not include Group B physical and chemistry property 

information. Group B product chemistry data were likely previously prOVided to 

the Agency. 

Table A: 

Product Chemistry (830 Series, Group A) 

Data Requirements Acceptance of Information MRID No. 

830.1550 Product Identity' A 471639·01 

830.1600 Description of Materials U - MSDSs were provided for the starting 471639·01 

materials. Infonnation identifying the 

supplier of cuprous oxide is inconsistent, as 

follows: 

- The supplier's address for cuprous oxide is 

identified as on the CSF and as 

on the MSDS and in the 

study assigned MRlD 471639·01. 

830.1620 Production ProcessL NA 

830.1650 Fonnulation Process" U ~ The process description does not identify 471639·01 

whether the paint is prepared prior to or 

during application of the paint to the granules. 

The process description also does not identify 

. A description 

of the procedures used to assure consistent 

composition of the product (e.g., calibration 

of equipment, 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 produced by 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 *Product ingredient source information may be entitled to confidential treatment* *Manufacturing process information may be entitled to confidential treatment*
58

Data Requirements Acceptance of Information MRIDNo. 

limits identified for on the CSF are 

likely in error and need to be corrected. 

830.1800 Analytical Method An enforcement analytical method was not 

provided in the data package; however, it is 

likely that a method was previously provided 

to the Agency. The active ingredient has not 

changed. 

830.1900 Submittal of Samples [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=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. 

!See Confidential Appendix A for additional infonnation 

2Por MPIEP products produced by an integrated fonnulation system. 

3Por products from a TGAI or MP. 

4May be waived unless actual/possible impurities are of toxicological concern. 

5Pive batch analysis required for products produced by an integrated fonnulation system. 

6If different from standard CLs reconamended in 40 CFR 158.175, this should be 

discussed in Confidential Appendix A. 

7 Abbreviate method 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* of Data 

Group B product chemistry data were likely previously provided to the Agency. 

830.6302 Color 

830.6303 Physical State 

830.6304 Odor 

830.6313 Stability to Normal NA Not required 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 *Inert ingredient information may be entitled to confidential treatment*
59

Physical/Chemical Acceptance Value or Qualitative Description MRIDNo. 

Propcrties* of Data 

830.6317 Storage Stability 

830.6319 Miscibility 

830.6320 Corrosion 

Characteristics 

830.6321 Dielectric. NA Not required 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 Not required for manufacturing-use 

PointIMelting Range I products. 

830.7220 Boiling NA Not required 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 Not required for manufacturing-use 

Partition Coefficient I products. 

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 submItted but IS not acceptable); 

NA=technically not 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 brief description, e.g., color - yellow or property value, e.g., density 1.25 glee. 

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

IIfproduct is an emulsifiable liquid 

2Ifproduct is dispersible with water 

Page 7 of7 
60

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) 308-634 t 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.
63

INDUSTRIES LTD. 

AR GRANULES (ALGAE~RESISTANT ROOFING GRANULES) 

FOR CONTROL OF ALGAE 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 if swa!Iowcd. Wash thoroughly wilh soap and water after handling and before eating, 

drinking, chewing gum, or using lObacco. 

FIRST AID: 

Ifswa!Iowed: 

-Cal! a poison Control Center or doclOr immcdiale!y for lrcatmCnl ad\'icc. 

-Haw person sip a glass OfW3.1Cr if able 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 of roofing shingles. AR Granules should be mixl:d wilh slandard rooting 

granules al a rate uf 2·10% by weigh1 and processed nonnaUy during manufacture of the shingles. 

For app!icalions whcre algae grow1h is severe. uniformly blend Wi1h standard roofing granules 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 of this product may be disposcd 1)f on 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 plastic bags - completely 

emply bag imo appliemion equipmell1. Do not reuse bag. Dispose of Clllply 

bag in a sanilary landfil!, or by incineration, or ifaUowed by stale and local 

aUlhorities, by burning. !f burned, stay OU1 of smoke. 

ManufaClUrcd by !KO Industries Lld. 

R.R.#!, P.O. Box 839 

105084 HW#7 

Madoc, Omario. Canada 

KOK2KO 
64

'~<-__________________________________________ ~~~~ __ ~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 

I 

*Product ingredient source information may be entitled to confidential treatment*
65

Form 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 of this 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: If your 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 of companies 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 of data requirements (the Data Matrix fonTl must be 

used). 

SECTION II: GENERAL OFFER TO PAY 

IRequired if using the cite-all method or when 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 of this application, to the extent required by FIFRA. 

SECTION III: CERTIFICATION 

I certify that this application for registration, this form for reregistration, or this Data-Call-In response is supported by all data submitted or cited in the 

application for registration, the form for reregistration. or the 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 of this product or an identical or 

substantially similar product, or one or more of the 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 of this application if the application sought the initiat registration of a product of identical or similar composition and 

uses. 

I certify that for each exclusive use study cited in support of this registration or reregistration, that I am the onginal data SUbmitter or that I have obtained 

the written permission of the original data submitter to cite that study. 

I certify that for each study cited in support of this 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 of the original data submitter to use the study in support of this 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'ltermille the 

amount and terms ot compensation, n' any, to be paid forthe use ot the study. 

I certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation a,ld evidence of tt'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 I fail 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 that the 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 . 
66

51 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

( ) 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 0.25 hours per response for registration activities and 0.2

reregistration and special review activities, including lime for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any o

information, including suggestions for reducing the burden to: Director. OPPE Information Management Division (2137). U.S. EnYironmental Protection Agency, 401 M Street. SW

send the form to this address. 

DATA MATRIX 

Dale June 25, 2007 EPA Reg No.lFile Symbol 8 f293·1 

Applicant'sIReaislrant's Name & Address Product 

Cantox U.S., Inc., 101 f Route 22 West. Suite 200, Bridgewater, NJ 08807. Contact: Earle Neslmann. PhD AR Granules 

Ingredient Cuprous Oxide 

Guideline Reference Number Guideline Study Name MRIDNumber Submitter 

830.1550 Product identity and composition IKO Industries Ltd. 

830.1600 Description of materials used to produce the product IKO Industries lid. 830.1650 Description of formulation process IKO Industries, lid. 830. f670 Discussion of formalion of impurities IKO Industries ltd. 830. f750 Certified limits IKO Industries Ltd. 

I 

--

---

. 

. 

. . 

Signature - 0: Name and Title 

G-K" .;..--..r- Earte Nestmann, Autholized U.S. Agent 

EPA Form 8570--35 {g..97} Electronfc and Paper versions available. Submit only Paper version. Agency In
67

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 (75 lOP) 

Thru: Karen P. Hicks, CT Team Leader 

Chemistry and Toxicology Team 

Product Science Branch 

Antimicrobials Division (751 OP) 

Thru: Michele E. Wingfield, Chief 

Product Science Branch 

Antimicrobials Division (751 OP) 

To: Marshal! Swindel! PM 33\Karen Leavy 

Regulatory Management Branch I 

Antimicrobials Division (751 OP) 

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 
68

BACKGROUND: 

The registrant has a product chemistry package in response to the review done 

under D341848. The package includes a label, a Confidential Statement of Formula for 

the basic formulation, and MRID 47391801. The registrant has refined the 

manufacturing process. 

FINDINGS: 

1. The concentration of the 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 of the starting materials and the manufacturing\production \ 

formulation process are acceptable. 

4. The discussion of the formation of impurities 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 detennined to be IOO.07Ibs/rr. 

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. 

II. The flammability is acceptable as the 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. 
69

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 of metallic copper must be declared as 

3.88% as a footnote below the ingredient statement. 

CONCLUSIONS: 

Product Science Branch of Antimicrobials Division finds the submissions for 

81293-1 to be acceptable, pending the label change which can be done on the next 

printing of the label. 
70

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 

81293-1 

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 
71

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 if this 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. 

I Explanation: 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 i Weter Solubla Packeging 2. Type of Container 

~Y" 'ta Y .. CJ Plastic Mot" 

" 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 of individual to b. contacttld, if ntlCtl$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 
72

June 25, 2007 

Document Processing Desk (REG FEE) 

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, 

Earle 

~J.L~ILuJ-.,,-~ R. Nestmann, Ph.D 

President 

Encls. 

Mississauga, ON 

Canada • 

Bridgewater, NJ 

USA " 

Fleet, HANTS 

UK 

*Manufacturing process information may be entitled to confidential treatment*
73

-

TRANSMITTAL DOCUMENT FOR IKO INDUSTRIES LTD. 

1. Name and Address of Submitter: 

Submitter: 

IKO Industries Ltd. 

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

Madoc, Ontario, KOK 2KO 

Canada 

Authorized Agent: 

Earle Nestmann, Cantox U.s. Inc. 

1011 Route 22 West, Suite 200 

Bridgewater, NJ 08807 

USA 

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

Registration amendment. 

3. Date of Submission: 

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 of Formula x 2 copies, 8570-27 Formulator's Exemption x I copy, 8570-34 

Certification with Respect to Citation of Data x I copy); Draft Label x 5 copies; 

Product Chemistry (Guideline References 830. I 550, 830. I 600, 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 
74

IFee for Servicel {812601iThis package includes the following 

New Registration 

, Amendment 

" Stu pies? Fee Waiver? 

\ 

vol pay % Reduction: _ 

for Division 

'AD 

BPPD 

RD 

Risk Mgr. [][] 

Receipt No. s-I 812601 F======i 

EPA File Symbol/Reg. No. I 81293-1 

Pin -Pun c 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 As 7 

\ 

Amount Due: $ ~ I ~J$O.~ I~ ____________ ~ 

Inert Cleare,d for Int7nded, Use 

Reviewer: WA/!u/{dLGo3ShL/ I' ::::;= 7 

Remarks: 

Uncleared Inert in Product 

Date: 1eP. 7/0 7 
75

June 25, 2007 

Document Processing Desk (REG FEE) 

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 

*Manufacturing process information may be entitled to confidential treatment*
76

TRANSMITTAL DOCUMENT FOR IKO INDUSTRIES L TO. 

1. Name llnd Address of Submitter: 

Submitter: 

IKO Industries Ltd. 

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

Madoc, Ontario, KOK 2KO 

Canada 

Authorized Agent: 

Earle Nestmann, Camox U.S. Inc. 

1011 Route 22 West, Suite 200 

Bridgewater, NJ OS807 

USA 

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

Registration amendment. 

3. Date of Submission: 

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 I: Administrative Volume: Fonns (8570-1 Application x 1 copy, 8570-4 Confidential 

Statement of Fonnula x 2 copies, 8570-27 Fonnulator's Exemption x 1 copy, 8570-34 

Certification with Respect to Citation of Data 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 

Company Name: lKO Industries Ltd. 

Company Contact: Earle Nestmarm 

Tel: (908) 429·9202 

~L.l~~'_~- Signature 
77

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 1 of 1 

211112008 
78

Via Federal Express 

Document Processing Desk 

Office of Pesticide 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 
79

June 25, 2007 

Document Processing Desk {REG FEE) 

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 

*Manufacturing process information may be entitled to confidential treatment*
80

MEMORANDUM 

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

TO: --'--'i\'-'-' 'c-' <",-<:~-'7"---' Reg u I ato rv Man age r 

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. 

If you 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