EPA Registration Number 

6836-279 Voll 
, . 

Aflnr a registrant has oblamed tina! rogtstrahon jor 1M baSIC prOOtIc!, Ih(l regi:;:lrant may then supplemanlally 

distr1bole his/her product. One form must be submitted fO( eacl! distrllxltor product and must be signod by the 

dls!ribolor Involved. The ~51c regls.tratlon number and the distributor company number must be shoWn, 

If a regl8lnml hal' a polenlial dl5lnbutor who does nol have <Ii company nllmber 8ufgned. she/he should havo the 

distributor apply, on letterhead stationary, to Ihe Registration DIVIslou 10 have <t number as.·.ignoo prior to 5ubrnrtHng 

this rorm 10 tho agency. 

rho t:omplftled rOmt musl have 

.~~~~~~~~====~ X-14 ANTIBACTERIAL TOILET BOWL 

• 

OantochlorTBS·3 

WD40 COMPANY 

P.O. Box 80607 

1061 Cudahy Place 

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" San Oi(!go, CA 921 ~0607 •••••• • •• • • 

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.. •• • • .. . .. ....... The distlibutor product must hava the !>lmU! composition as the basic: producl .,.:.. • • 

Tho distributor product must be manufactured and packaged by 1he same parson who ma~n<'lat!res and packages 

tho registerotl baste product. •••••• 

The labeling for th~ distributor product must bear the- Silme claim!> as the basic product, provided, hOwl..wl!J': ,!~;'lIt 

specifIC ctaims may be deteted ir by doing so, no olilef changes to the label ate necessary : ••• 

The product must remain in tlte manufaCluwr's unbroken container, •••• 

The labet mU$t bear the EPA reglt:.trallon number of the basic pror;luct, fQllowed by a hyphel1 and the distributor's 

company number. 

Distributor product labels must bear the nam~ and address of the distributor qualified by such larms as ~packed 

fur ,."~ distributed by",,~; OF sold ~ to show Uutt the nume Is not !hut of the manufuciurur. 

All conditions of the btlsic II distributor pruduc!s. It is Ihe rosponsibility of Ihe basil; 

I " 

'No """""""~i!l!.!~' ,,.x,,,"w",,, the {M;\lot,..liOf Pmd(.l(~ NilIlm "lipocifl«L:l\mvt1. !lUhfect ro !t\f! rP¥JItI(IM $p<X~fu)d WI Vir. Notice 

Oru. 

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,',." '",d , , "'M., , '" f"m "'<,,m m,,, '"''1,,01 

_ ~nhcd Stnth 

~EPA Environment;;tl Protection Agency . r ,j' 

Oflir;t 01 Pesllcide Prog!lIfI'\; 1150SC} - 'l .I~ A L • Wnhi"9lo",. DC 20460 

Notice Of Supplemental Distribution of a R. ,', Pesticide Product 

\ftN il regiStrant has obtained fin,,1 registration for the basic product, Ihe iegi:mant may then supplcmentally 

;istribute l'lislher product. One form must be submitted for- each distributor product and must be signed by the 

istributor involved. The basic registration number and the distributor company number must be shown. 

! iI registrant halt a potential distributor who docs ndt havlJ a company numbe' assigned, shelhe should have the 

i5tribulor applYK on leuerhead stationery~ to the Registration Divis-ion to have 8: number assigned prior to submitting -lis form to the agency, ' 

-his Notice of Distribution must be submitted bv lhe basic registrant. The completed fOim must have 

,'Je <and I of both the registrant and the dislributor. 

FA, , N"""" .1 p""",, C(l~Gny Numbet 

6836·279 71903 

Note: 00 not lubmlt distributor lubels 

>lffIn" <;01 R"gi9lotlM f'foduet lb.J$iC prt'lduct IbyEPAI ,P""." N_ 

Dantochlor TBS-3 X-14 Antibacterinl Tei let Bowl Cle.ner! 

,," 'P 

HPD LABORATORIES, INC. CANCELLED 

d/b/a Global Household Brands Lonza Inc. 

379 Thornall Street (1S·h Floor) Regulatory Services- Edison, NJ 08837 ••• , , ,.., I " , 

• Raad All Condltlons I..f./~ 11'13 f.,dD 

I ';" :' : ,. The distributor product must have the same- composition ""5 the b<lsic producl. • ::.::. • · The distributor product must be manufactured and packaged by lhe same person who manufacture$" , 

the registered basic pro-duct. -:: .:.. _ ... ' .. ' 

, The labeling for the distributor product must bear the same- claims as the basic product, provided, , that .. : .. ' 

specific claims may be deleted if by doing so, no other changes to the label are necessary. • ••• The product must remain in the manufacturer's unbrOken container. • , '. 99 •• 

· ae label must bear the EPA registration number o-f the basic product. follQwed by a hyphen and the ""st,;lttutor's 

mpany number. .. •• 

0, Distributor tlroduct labels must bear the name ilnd ilddte:u of l_he disttibu[or qualified by such terms as "packed I 

I for ... ~."dlsttibuted by4 .... ; or "sold by ... ~ to show milt the name Is not 'that of the manufacturer. 

7. All conditions of the basic rcgistra[ion apply equally to tjisuibutor products:. It is Ihe responsibility' of the basic 

reoistr;Jnt to see that all distributor labeling Is kept in compliance with requirements placed on the buic product. I '~ Distributor 

',v, lnidtrd IQ /HIli", rill '),'stribllMJ- Product NMfltt '¥/It-dfi,,d foMWi. 5:lJbjt>cr M rh. aJl'ttJitkJfI:t; :{I,clfl,t! Off this Notie" 

SillMllJflJ lid Illft , Dllt", 

l.J< )Z -' 

, 

(, -.;t\- 0-<) 

, 

Registrant 

'lIiJ1ttfl lh4t tb. ';;~tribllllJ( rs~mf1d ~lIoVtt mlly "';::fllol.l/" <#mJ $wllh" l)!:r,ttibqtfH PrlJdur,:/ $pf/t'ilor,nJ fJ"()~". "J>JUI'",r fa rhn t:nndiliarm If/lflrJIiftt! OIJ flu: 

'"~,t;,u __ RegulatolY Servfces 

l.O"".lnc. O'l(?J:>/aiJ , , Whit,,· EPA I 

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON. D.C. 20480 

OfftctOf 

Ml£YENnOU, I'fSTfCIOS 

A!m"lO)r:lCSUJ!S7~ 

Rober! J. Sloa" 

Lon7.a. Inc, 

17· 17 Route 208 

fair Lawn. N.J. 07410 

SUBJECT; July 2. 2Q03 Appllea.ion AtncntbooJlt 

DlUllOchlor 113S-3 

EPA ReglSlIation 6836-279 

Dear Mr. Sloan: 

The labeling referred to above. !Submitted in conneclion with registration under theFcdc:ral hlSt.~tkidc. Fungicide. and RodentIcide Act, as amended. is acceptable. In summary. 

your l'CtIiJcst to revise thl; First Aid. Pn:t.:autionary. and Storage and Disposal statements is 

""ecpl.blc~ 

A copy of your 'Pllrovcd stomped Inbcl i. enclosed. 1'("'''0 submit a copy of your revised 

finished lahet for our fill!s. If you have ruty questions rrgmding this letter. please contact Tom 

Luminello ol my ,Infra, (703) J08·8075. 

Enc!o:mrc 

Sincerely yours, :.J1{ " j I Ii ~ . A ,yY--, • ...:;.JN.-vJ.. 

" (~~~bert ~ Brennis 

.All~ Product Manager (32) 

\ Regulatory MIDI.gemcfll Branoh II 

Antimicrobial Division (751O-C) 

4 
P~ecAunoNARYSTATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS 

OANGER.- Highly conosive. May be fatal ff swaHowed. DO NOT 

TAKE tN'TERNAll Y. Causea eye and skin damage. Irritating to 

nose and lhfOilt. Avoid breathing dust 00 not get Into C1OG. on 

skin or d01hing. Went rubber gloves when handfing and wash 

IhOroughly after hand6ng. 

FIRST AtD 

IF IN EVES: Hold eye open and rinse $lowly and ~nllY wilh 

waler for 15 - 20 minutelL RtmlOVe conlad Ionses, if present, 

after Ihe flt'lt 5 nrinUI&S. then continuB rinsing eye. 

IF ON SKIN OR CLOTHING: Take off contammated clothing, 

Rlnse skin immediately wIlh plenty of water lOr 15 - 20 minutes. 

IF SWALLOWED: Call a poison control center or dotlOr 

Immedmtely for trootmBnl advice, Haw piUSon '.lip a allu,s DC 

water II Jble to swallow. Do not induce wmiling unJ"'$ told to do 

so by the pol$on conlrol center or doetor. 00 not give anythIng by 

mouth to no uooonsclotJ$ peroon. 

IF INHALED: MQve person to fumll air. If person 1* rurt 

~Ihtng, eall 911 or an ambulance, lhen give mtiflCim 

.plration, preferable by mOUft1·t(I·mOUlh If posnlble. 

Gall a poi$Otl control oenfC:t or doc1or for treatment advice. Have 

Ute producI conlBlner or label willi you when calling a Pofson 

Coottol Cenler-or doctor or going for treAtment 

Note To Physlc~n: Probable mucosal damage- may 

contrnindicate the use of gastric lavage. 

PHYStCAL AND CHEMtCAL t-fAZARDS: 

CHEMICAL HAZARD: STRONG OXfDIZING AGENT. K~ away 

from heal ornamc. Mix only with water. 

STORAGE AND DISPOSAL: 

Store In Original contaIner In areas InaccesSIble to chl1dre-n In a 

cool, dry. well-vcnUlatod area DQ not $tore at elevated 

temperatures. Discard empty container in trash. 

_~? Comments? Call (mserl ~ I1l.lIl1barIIDfU) 

Tll1ro ptodUd contains no phuupllmes or phml:phO(ous 

compound!.. 

NomeD. 

Ooea not harm plumbing or ru!!plic lank!.. 

Concentrnlect 

Lellves tmwI89.9% (g6lTn)(baetlJria) frae 

OANTOCHLOR TnS·l rGS~27g) 

EPA O!<)tt uwe-I dated 6124f03 

DANTOCHLOR TBS.3 

'ff-Taffk SanltkttrfOr Homes. SChools end Hospitals 

In*TD(Ik AuJomafk: ToIhJt Bawl Clearmr 

Soniliz4's Tcifet Bowl Wslltf Alter Eacll Rmd, 

Ki/l$ 99.9% Of (Genns)(Bm:lf1TiaJ hI TnlhfI Bawl 

Wai6rAfterEschFIush 

Chums lind tJoodorizD~ WillI Evert Flvsll 

Heipll KfUlP YOllr Toilet Bowl Fresh and Clean 

Reoommendcd for frequenlly nushed toIlots 

Kffls (gcrms)(bactClJa) forOW!f 1 month 

Kills E. cali 

Kills Slapltyfacm."CtI:t mlmU$ (staph) 

Kills Salmonella cholnrnesws (salmonella) 

Kills PS9udornt:mM aeroginosa (pS(JudomOllll$) 

Kills common household (gcrms){bac/ori4) 

K11It; odor..causing (flBTmsl(bactena) 

Active Ingredients: 

1 ,J.dichloro-5,5-dimolhylhyc:fa.ntoin ." ....•.... ,., ." •.•.. " ._" ' ..• 52.7% 

~~~;:::~~~~~~~~~~~~~~.~~i,~.::::::::::::::::::::::::::~:;~ Total; .................... " ........... , ......................... _ .......... " ... 100.0% 

MInimum aVa!labta chlont\Q 44.2% 

KEEP OUT OF REACH OF CHILDREN 

DANGER 

See SMa I Back Pam!! for Precaufronary Statenn!flls and Find 

AId 

EPA Reg. No. 

EPA Est No, 

NetWefght 

0036-279 

(in~rt EPA Est. No. here) 

50 grams 

Manufadurod by; 

LONZAlnc .• 

17~t7 Rlnrte 201} 

Fair Lawn, NJ 07410 

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When used as directed, Dantochlor TBS~3 will sanitize toilet 

bowl water, keeping it clean, clear and free of odor. Dantochtor 

T85-3 gives the effectiveness of chlorine wllhout the chlorine 

OdOL 

Dantochtor TBS-3 sanitizes toilet bowl water by klmng 99.9% of 

(germs) (bacteria) within 15 minutes atter each flush. Each tablet 

sanilizes for one month. Eliminates 99.9% of (germs)(bacleria) 

wtthin 15 minutes after each flush. 

Remove tank cover and cut open package. 

DIRECTIONS FOR USE: 

II is a violation of Federal law to use this product In a manner 

inconsistent with its labenng. 

To Sanitize. Clean, and Deodorize: 

1. Clean toilet bowl thoroughly. including under the rim. 

2. Remove toilet tank top. Hold plastic pouch away from face. 

CuI pouch open with scissors on dotted lines. 00 not touch 

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tablet 

Rush toilet. Before tank refills, hold ptastic pouch over tank 

and drop only the Danlochlor TB5-3 tablet into right rear 

comer of the tank. (See diagram) Discard plastic pouch and 

wash hands thoroughly. 

4. No removal necessary, Each tablet sanitizes for one month. 

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When tablet nas dissolved, replace wilh a new tablet. 

Product should only be used in a toilet that IS flushed 

regularly . 

(OPTIQNAL MARKETING LANGUAGE): 

• Antibacterial 

• CHLORINE CLEAR with Bleach 

• Sanitizing Formula Cleans & Deodorizes 

• Cleans & Deodorizes with Bleach 

• Keeps waler crysial dear 

• Easy to Use - Just drop in tank 

• Kills 99.9% of (germs){bacteria) for one month! In Toilet Bowl 

Water after each flush 

• Not harmfUl to Plumbing or Septic Syslems 

• Leaves bowl sanitary 

• Makes cleaning easy 

• Controls odor causing (germs)(bacteria) in the bowl waler. 

• Controls the growth of (germs)(bacteria) that cause odors 

• Controls odors caused by odor-causing (germs){bactena) 

• FighlS tough stains 

• Keeps your toilet bowl stain-free 

• Continuous real bleach cleaning and deodorizing 

• No mess in tank 

• Bleach cleaning 

• For colored toilets 

CCO ? 0 v1.:1 .J 

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DANTOCHLOR TBS-3 (6836-279) 

EPA Drnfllabel dated 612-4103 Page 2 012 

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Document Processing Desk (AMEND) 

Office of Pesticide Programs (7504C) 

U.S. EPA 

Room 266A, Crystal Mall 2 

1921 Jefferson Davis Highway 

Arlington, VA 22202 

Attention: Robert Brennio (PM-32) 

Dantochlor TBS-3 

EPA Reg. No. 6836-279 

Label amendment 

Dear Robert, 

Lonzo 

Lonu Inc 

17~17 Roule 206 

Fairlawn, NJ 07410, USA 

Robort J. Sloan 

Per1brman~ Chemicals 

Regulatory Sewices 

Phone: (201) 794-2610 

Fax: (201) 696-3569 

bOI.M;iOlll\@lonza.eom 

July 2,2003 

Lonza is submitting an amendment to the subject product's label. The purpose of the 

amendment is to: 

1) Update the First Aid Statement, Precautionary Statements and Storage and Disposal 

Statements as required by the applicable PR Notices and the US EPA label Review Manual. 

In support of this amendment, enclosed are the following: 

1. EPA Fonm 8570-1. Application for Pesticide Amendment, OPP 10 No. 280712 

2. Five copies of the proposed label. 

If you have any questions, please call me at 1-800-777-1~?5, ext. 2610. 

Robert J. Sloan 

Sr. Regulatory Services Associate 

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7 
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oEPA United Stir .. 

~ 

Registration OPt" Idantmat Ni!mfHlf 

Environmental Ptotectlon Agency Arnen" ...... "! 

WuNngton. DC Z04G\) Other LUU' " 

I for 

l,-CClmp~lProduct Numtm l.E"APr~~ o....tlll:lft!!m 

6836~279 Velma Noble 0"- 0"","'" '.' ~T:3S:~N~" PM, 

Taam31 

ar Applicant fltn:/uft ZIP C'H/.} 6. &:pedhlJd ReveJw. tn accordance with FtFRA Section arol(31 

LONZA.lnc. (blli). mv prodl)~ 1$ $Imltar or identlc.ai in compOSition and laboflng 

17·17 Route 208 "" Fairlawn. NJ 07410 EPA Reo. No. 

I! Am"""""n'· 

[ ] Ch.ck. 

"""on 

if ffIb /$ 

.... 

• ""w 

w. 

flfidrrnfl 

~ 

U Fin" PMte<;! 11IIm. In f"lI~"", teo 

AgoMy '-nef dllWd 

R!IIIisbm"oion. in '"Conn to Acanov 'entlf dllt~ o -<OM. Too~ Appfll:.tion. 

o Noti1k.tll:ln ~ Explain b,/ow. o OUUlf ~ &pIfJIn b/llow. 

Expl.n.tion~ U ••• .,Jd"i6tl1if pbQIIlt' If nacft#sMY. tFer fiKtIon I And Silc!loO 11,1 

Upd<IM!he Fi~ NIJ Siammllflt, PfN".auIIMllry StrJltltnantt; awl Stomgti Y\d r~1 SU't!.etI\enIIl till requlloo by lhe ('Ipf)Iicab'.c PR NoI~s Otld Ih</ US EPA 

UdJuI Re~ Manual. 

·111 

.",_wm ... 

Podr;_QffiQ lu~,_"" ~ Solubi. "'ackeolf'lO ~Ccmf.m., 

El:~ v .. _ Ve. _ ...... '- N. N. _ Plut!.:: 

G16 .. 

~/Jonmu" I ~,,;,~., No,~r ~,!" ..... No., p4)t L '-' .- conll'lilm' ~tail'\lrr 

, 

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'LobO/" 

I--

G, MaMor '" Which I..ab,t i. Affhted to Product 

~~ o Or~t "--. 

,-IV 

11. ,I>" -. I "WI~~"'''''''''') T1 .. 

Robert J. Sloan Sr. Regulatory Services Assodale 

CertUrcDtkm •••••• • •• .. ~~--.... 'fotOlTl$rtl$ I hove,7.-:: ,on th/; torm ttnd IlIl Mtoohmcnh' tl!.r.tq a:rl true, IOCUflltt ond O~M". .0-

j 1M rfl\dll6CH1'IQ SIM:Mnllf'\( IMY be puniMiabhl hv flM (U Imftri.~ at • : .:: Ctympedl /1/ ., • • 

~4 •• 

Z. Sion.$l\.llll 3.110. .. : ... • Sr. Reguiatory SMvICC AuCda!§ •••• • • •••• 

:~ Nomo " 5. Ditta // • • 

• • • Robert J _ Sloan 

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EPAI "R, ...... " I odilinlUt lUe -. • Copy ....... 
~~~ ~ 

~ .... "" F.,m, , (¥P'" .- OMaH", U",,,",,,,, :L't'tS<.t~ 

&EPA Environmental Protection Agency ~ , 

Olfit.l (If f'oe~r.M. PUlOUltM 17£OSCI ~ \ f' \" ",,; , W •• hinQton, DC 20460 "), 

Notice of Supplemental Distribution of a Registered Pesticide Product 

I ~~!!fh~.:~glstrant has. obtained timd reglstmtion for the basic product. the regfsUant may then ;.upplementally i hls/her product. One form must be :SubmItted for each distributor product and must be signed by th. 

distributor involved. The basic regismrtion numbl!r and the distributor company number must be shown. 

: If a has a potential distributor who does- ndt have 2 company numbgr assigned, she/he should have the 

;thr;f~;;' apply, on letterhead stationery. to the Registration Division to have a number assIgned prior to suhminlng 

to the agency. 

it~. Notice of Distribution must be submitted bJ the basic registrant. The completed form must have 

of both the and the isUibutor. 

EPA nltgitltltlil)h CC01Jl.roy Numbflr 

I 6836·279~i 'i 71903 

Note; 00 not submit distributor labels 

! Hom'" I '''''','' f'r¢d.LKt HIIm. I. Dantochlor TBS-3 X-14 Ant'lbacteria I Toilet Bowl Cl I 

Namv Ind Addnl:fS (If Z/Pcod,ll 

HPD LABORATORIES, INC. 

d/b/a Global Household Brands '" • • • 

379 Thornall Street (15"' Floor) ., 

Edison, NJ 08831 

RBinJ All CondrUons Bofore • • : ........ I: 

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••• • ~'. I' 1. The distributor product must have the same composition as the basic product. • ., • I 

i 2. The: distributot product must be manufacwted and packagsd bV the same person who manufactures ar'\l1 

the registered basic product. •••• , . I 3, The labeling for the distributor product mU5t bear the same claims as the basic product, provided. hot.tt!ter. that , 

I 

specific claims may be deleted if by dOing so, no other changes to the label are necessary. • ••••• I I_~:'product must romain in the manuf.cwr.r·s unbroken """tainer. • ... , label must bear the EPA registration number of the basic ProdUC1. followed by iJ hyphen and the distributor's 

company number. 

6. Olsuibutor product label!; must bcar the name and address of the distributor qualIfied by such terms as ~pac.ked 

i 

'7. for •.. •• "distributed bV ..... ; or "sold by ..... to -show that the name is not that of the manufacturet • 

• All conditions: of the basic re{lisn-ation apply eQu311v to disulbutor produCts. It is the responsibility of the basie 

registrant to see that alt ditotributOr labeling is kept in compliance wifh; requirement$ placed on 11l1l1 basic product. 

"" Dis1tibutor 

i $utJfttt:r M :h~ CQ(}t!iWI/J£ 1Jp.tifi.d~" Ih;$ MU(<<J. 

SigrUJlu,. ,.j Tj.I. O'hl! 

<il ' 51- (;, -';1\ - ,rJ 

Registrant 

~~~~ thllr th. disrributol' (filmed nbavlI may dlJ;rriblJ(e "mt sel/ihe Dhrrlburor Producr :Jpl!tir.,d hh",,-\!". :/oojilci to the Ct'InditiofllJ sp"d/iwl CtI lhis 

'TS&Ji. .r-; Regul.toryS_ ""y,YJI c;iJ Lonzalnc. 

, 

, EPA Form 8$10-5 lRtl'o'. 1·94) Prvviaus editioM Mit' (tb~(llvtt'. ~. t't·~ Whilo· EPA 

I 9 

:r IJ_t\: C-i4 1m _-"t_$IMU_lel' 

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Th~ annual respondent burden fO!'.the ~oticc of Supplemental Di;;triblltiOH_ of a 

Registered Pesticide Product is estimated to average 15 minutes peT re..<;ponse~ indudinK 

time for reviewing tlle instmctions, searching existing data sources, gathering and 

maintaining the data 11l?"eded. and completing and reviewing the information. Send 

comment'; regarding this burden, to Director, Regulatory Information DivL"ion, 21371 U.S. 

Environmental Protection AgencYt ..tOl ~1 Strt.'-Ct, S.\V., Washington, DC 20460: and to 

Paperwork Reduction Project (OMB No. 2070~OO44), Office of Management and Budget • 

. Washipgton, D.C2Q503. M,:u:ke~~A!ten-.ltion D~')k_Offi~er~(or EPA. _-~ _ . 

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Ruth Trager 

Lon7~ Inc. 

17·17 Route 208 

Fairlawn, N.J. 07410 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON. D.C. 20460 

JUN 1 2 2000 

OFf:1Cli OF 

I'flEVfNTlOU, PESTlCIDfS 

ANO TOXIC SUflST ANCES 

SUBJECT: Revised label dated 5123100 

Dantochlor TBS.3 

• EPA Registrdtion 6836·279 

• 

Dear Ms, Trager: 

The Jnbeling referred to above, submitted in collllcction willi registration under the 

Federallo.sectici,de, Fungicide, and Rodenticide Aci, as amended, is acceptable, subject to 

com.ment.. below. A stamped copy is enclosed for your records. 

The Agency has reviewed the revised labeling submitted in response to our letter of April 

18.2000 and has no objections (0 these changes: at this time. We will be reviewing CU1l'elll 

marketing language that may misrepresent current efficacy policies. The Agency v.iU review this 

product's confonnance with PR Notice 97* I as part of the re-registration of the 

Dihnlodinlkylhydantoins (case 3055) . 

If you have any questions regarding this letter, please c-ontacl Tom Luminello of my staff 

at (703) 308·g075. 

~~~-1~~~/ Robert S. Brennis 

Product MllllllSer (32) 

Regulatory Management Branch II 

Antimicrobial Division (751O-C) 

11 
PRECAUTIONARY STATEMENTS 

IIM'..ARDS To IlUMASS AND DoMESnC A~uI.U.s 

DANGER. Highly corrosive. May be falal ifswuUowed DO 

NOT TAKE INTERNALLY. CIIUses eye and skin damage. 

Irritating to nose IlIId r.hroat. Avoid breathing dust. Do Mt get 

iLlto i..'Ycs. on skin or clothing. Wear rubber gJOvtS when 

hnrnlling and wash thoroughly after hwtdling. 

FIRST AID: 

Ifln Eyes: Uoldeydids opcn and nosh with II steady. gentle 

streMl ofWlner for 15 minules. Get medical attention. 

Ihn Skin: Wash with plenty of soap und water. Get medical 

,mcLltion ifirritation persists. 

If Inhal«l: If LInt breathing, give mificial re:spinalion, 

preferubly. LIIouth·to·mouth. Get medicalal!entioLi. 

IfSwIIl!l)weif: Calla doctor or get medicalattentil'ln. DO 

NOT indUl."e vomiting, 00 not givc Wlything by mauul to lUI 

ullcunwious persoll. Avoid I1lcoltol. 

Note To Physieian: Probable mucosul dllmage IIIIlY 

contruintlicutc the use of gastric lavage. 

PHYSICAL AND CUEMICAL IlAZARDS: 

CIIEMICAI.I1AZARD; STRONOOXIDIZINO AGENT. Kecp 

aw;,\y from heat or flllme. Mix ooly with Wfltcr. 

. ~""'~D I ,'" JUN 1 2 2000 

:1:,;- FC';:f;;J if.k!~. ~IN <>!! /,:;J;;S kll!l'm 

i <' "'~ ;i'~L!t,';;J L):[(4:; 

! ( i" !.'.Jc~L21L 

fhINrOC/(l.OH i'JJS..J 

EPA Reg. Nu. 68JI$-279 

512)/00 

I'i1.gc t 

DANTOCHLOR TBS-3 

[n·TtJ1/k Sanitizer fl)r HQlllCs, &Juwu Qnd (fospilals 

In·Ttmk AufomoJic TQilet 80wl C/NJrer 

Sanitizes Toilel Bawl WUIU A/kr Each Flush 

KiJ1s 99.9% Of(Gemu)(IJodaih) In Toikt Bowl 

Water -1Pv Each Flush 

Cleans and Dtodnri:.es WIth EW!ry Flush 

Helps Keep Your Toilet Bowl Frv!lh and Cleal\ 

RecQIJIllfcrnledfOl" fru/uenrly jTushed lolle(s 

Kills (germs)(bactuio) for O\'fr I monfh 

Kills E. Ct)/i 

Kills Slaphyloc(JC{:U$ (/UI'IUU (staph) 

Kills Salmonel/a c/toIel'tlUuts (salmonella) 

Kills EnrerococcusfaecaUs (t/rep) 

Kills Psrutlomonas Qf!ruginosQ (pJ'flUdomonas) 

Kills cOmmUtL flomehol« (gcrnu)(bm:ruillj 

Kilis adQM.'{lUsillg (germt)(bacterfa) 

Active Ingredients: 

1,3-dichloro-5,SO{) imethylhydl!Jltoin 

1.3-dichloro-5-ethyl-S-mcliLylhydWltoilL 

Inert lngredicnts~ 

TOTAL: 

Minimunt available ddorine 44.2% 

52.7% 

10.5% 

3()·~t 

100.0% 

KEEP OUT OF REACH OF CHILDREN 

DANG.ER 

See Side/Back Pinel For P~e.uttclluITY StAtements 

EPA Reg. No. 6&36·279 

EPA Est. No. 6836·PA-01 

Net Weight: !ill gnuns 

Manufactured by: 

LONZA ILlC., 17-17 Route 208. Fair I.awn. NI 07410 

When used as directed, Dantqchlor TBS-J will sanitize 

toilet bowl water, keeping it CleM, clear and free of OOor. 

DaAlochlor T85-3 gives the effectiveness: of chlorinc 

witltout the chlorine odor. 

DanlocblorTBS-J sanitizes toilet bowl water by killing 

99.9%of(genns)(bacteria) within 15 minutes after each 

flush. Each lablet saniloo for one month. Eliminates 

99.9% or(germs}(bacterill) within 15 minutes .ncr Cl\Ch 

flush. 

Remove tank CO\'l::r and cut open pmage. 

DlRECfIONS FOR USE: 

It is a viohuion of Federal law to usc this product in a 

LlUlIUlcr ineonsistent with its labeling. 

To Sanitize, CleAn, aud D«xJoriu; 

I. Clean toilct bowl thoroughly. iLlcluding under the 

" 

3. 

4. 

rim. 

Remove toilet tank top. Hold plastic pouch away 

from fsce. Cut pouch open with scissors. On dotted 

linC$. Do nut tOllch tablet. 

Flu.slt toilet, Before tank refills. hold plastic 

pouch ovcr Ilmk and drop only thc DlUltochlor 

mS-3 tablet into right rear comcr ofthe tnnk. 

(See dillgram) Disctttd plastic pouch and wash 

hands thoroughly. 

No removal necessary. Each tablet sanitizes for 

otle nmnth. When tablet has dissolved, replace 

with II nclV tltblct. Product should only be used in 

a toilel that is noshed regullllly. 

STORAGE AND DISPOSAL: 

Store in original conlaincr in 1U't'll." inaccessible to 

small children In a cool. dry, well-vcntilated area. Do 

nqt store at elevated temperatures. Discard empty 

container in trash. 

Que:>1ions? COIIVIlI.'UIS? Dill (ill.~t te\t.'}'IIlOne number here) 

1111s product contains no phosphates or phosphorous 

compounds. No mess. Does not hllnn plumbing or 

scptic tanks:. Conccntrat.ed. Leaves bowl 99.9% 

(gennXbacteria) free. 

J !( F £X:oot\:'S aILcmaLi~""~llef\~tllmSl:II\}Jc Il\Ilgull8c e 12 
I 

{QPTIONA/. MARKH1'1NG IANmJ..\GE): 

• Anlibw.:l«iIlJ 

to CIIIA)JlfNI! CLhAIi Will'! l3l~h 

.. SJlI1i1t..jItl<}'f}fmlJhlClrnm~ & D¢OIluriltcs 

.. Clean' & lkmJtJrizeli with Bleadt 

.. K«p$ WIl,(et ~!llI dw .. f:1I.\)' to U:re _ JIL~l limp In tftnl:. 

.. Kills 99,9".4 uf(gctmS)(bllCltTiu) for Ullt mOllth! III T.,ih::t Bowl Wale! afte!' e,1(h flU5h 

.. Not hnnlli'illw f'lumhln.g or SCPllC S)'SlCilU 

.. 1.!:IIvl:3 bowl s.!wiiJuy 

.. Muke:u:k<tlllll&1.W 

it ((lnlmh odm' ~t1$lng(germ$)(\mt:tcti3) In the bowl wafa. 

.. Conlmls the growth pf (senm)(ltIK-1erill) Ilw C'lUJli';) odgF.J 

.. Co)llh'(ll~ oOOlS taun.1 by oOOr.<,lllsinf; (sernw.){Mtlcril\) 

.. FiJlIIlS WUgI\ :tWn\'! 

.. i((('jlS YOIl! wll« wwi $tllm-fr(,e 

.. ConliuoolU pelll blcacl1 ,",e~w.il1it nnd dtodorWlIK 

to No mess ililrutk 

.. 1lI1!acl1 cl~ning: 

.. Fur .;()Il.1t«iwilo:l$ 

"-,if ,~ "0---"" r , , !z't ~\$0 ' 

,fUN 1 2 2000 

i ~",F'flj(:fht.!mliil.0:;,\s:hW, Ft:llWmiillS , h: ;""£.)(;4 At! &XZhMklMi lCfll1!! 

, ,\,"~,,'d<,fi,),~OO:1m 

,-- Ii"_ 6':1;!'- - 1 7' "" """~-~~~-

-------------------

IM.NTOClII.OR TJJ!J.J 

6PA Nf#'. N#. W~7t /'0"" I. "'1X1W«N.l\k(lJ»lhwiUU1"bN~/j\l!e htlrl\llI$.( • 13 'In" 
• 

• 

'}, t;. nU!flC11v.l:!ffkt !'JlWccrtori i\~-;j 

'J!fL::& ,d H;!lULt;;., h,,;t=.1< 

""ttI!I~~ O!Vl~ (1nOC-"l ~(U "M"SU$,W, 

W...mnglom, IV: 7t»6n 

NOTICE OF PESTICIDE: 

_L Registmtion 

_ Reregistration 

N.tmu/IJ Addmu ... rRqiamM /1n;;llIIk lJJ> CIl<k) 

Wendy A. McCombi¢; Agent for Lon7J\~ inc 

clo Lewis & Harrison 

122 C Street N.W., Suite 740 

6836·279 

N~_I,fVe.Il,* f'fu401t Dantochlor 

I13S'3 

This product is conditionnlly registered in accordance with FIFRA sec. 3(cX7)(A) provided that 

you~ 

I. Submit and/or cite all data required for registration/reregistration of your product under 

FIFRA sec. 3(c)(5) when the Agency requires all registrants of similar products to submit 

such data 

2. Submit two copies of the revised tinal printed label for the record changing the EPA File 

symho16836.ETO to EPA Registration Number 6836·279. 

3. You must make the following changes to your proposed product label before tJris product 

can be registered: 

TIle usc oftltc phrase "kills 99.9% of (germs) (bllcteriaY' is unacceptable. Claims for such 

killing action imply a disinfectant level of activity, thus suggesting a higher level of activity 

than what we accept for an in-tank sanitizer. In all instances the term ~~kiUs» must be 

replaced by «rcduce.~!l or "contrnLo;"OD the Dantochlor TBS~3 label. 

Efficacy lor thl:-s.C products is pritnnrHy against bacteria, The use o-fthe teon germ(s) in the 

claims makes tbe inference of efficacy against a broader spectrum of pathogenic 

microorganisms (bacteria. fungi and viruses). In ail instim(cs the term "germ(s) should 

he replaccs with the term "bacteria (and fungi)" on the Dautbchlor TSS-3 iabet 

~"'~ ~c\.l.~ ~ Robert S. Brennis 

Product 

APR l!l 2f11)JJ 

14 
---------------------~~~-----

• 

• 

" Page 2 (w\ 

EPA Reg. No. 6836-279 V 

APR 1 8 2000 

4, Revise "'Controls odor-causing (gcnns)(bactcda) for One month in the bowl water" to read 

"Controls odors produced by many odor-causing (genns)(bacteria) for in the bowl wateF~. 

5. Revise "Controls the growth of (genns)(ba.terin) dIal eaose odors" to read "Control, tho 

growth of many (genns)(bacteria) that cause odors¥!, 

6. Submit two copies of the revised final printed label for the record. 

If these conditions are not complic-d with, the registration will be subject to cancellation in 

accordance with FIFRA sec. 6(e), Your release for shipment of1hc product constitutes acceptance ofthesc: 

conditions. 

A stamped copy of the label is enclosed for your records. A copy uf our product chemistry 

i!vulu.1.tion and efficacy evaluation are enclosed . 
IlRECAllTlf1NARY STATEMENTS 

1 I .\ZARDS TO IIU(\,I,\'l'lS AND DOMESTIC ANIMALS 

,q(JER. lIighly Cl"rn~;;',·. May be fatal if swallowed. DO 

r TAKE INTERN,\L!.)', Causes eye and skin damage, 

""ling tt) nose :1111111"";1\, (\void hreathing dust Do not 

'.uo eyes, on skill f'! (!i'lhiug. Wear rubber gloves when 

, !Hng, anti wOIsh thM("'l~III\' nflcr handling. 

1(ST AID 

;., -,.;yes: Hold eyelills ('ren and flush with 1\ steady, gentle 

~'Hll of WilIer for 15 mil!l!les. Get medical attcntion. 

"" Skin: Wash with plf'nly of soap and water, Get medical 

,,~,'tion ifirritatiou Ile(siR'~. 

l'llillled: lrnot hrcilthinr,. give artificial respiration, 

~!"'rnbly, mouth-to-DlII!!!!!, Get medical attention. 

:;wallowed: Call;ll (intUIT" Of get medical attention. DO 

, imluce vomiliul!. "'n "n' give anyUling hy mouU, to an 

""nsciou5 pen",,, A v(\i. 1 alr:l)bol. 

'I rG TO PHYSICIAN; Probable mucosal damage may 

"'fa indicate U,e use (11' ~;!~tric lavage, 

PHYSICAL ,\!'n rJIEMICALHAZARDS 

. "iMICAL IIAZARD; STRONG OXIDIZING AGENT. 

''''p away from beat (If name. Mix only with waler. 

'k<1- " , 

~ wiU I :fr, Nee J:, e 

A II IN,: «,0> t \.",,:,f. :!~~!;~~~:!::: '\\ lJJ FHi i.etTu. ii",. ,'r-. l'-:tr{>:"~A,II~,JJ)OO (LVvl f'ii 

or 

DANTOCIILOR TBS,3 

In,TIlIIN. Sanilizcr Jor Homes, Schools, amlllo,fpifllh 

1,,·Tlmk Alltomatic Toilet 8011'1 Cltul/fer 

Sanither Toilet Bowl Wmtr After /:.'oc/l Fhuh 

f9N!99.9% Of(Germs) (1Jllcll!riuj In Toil!!t III/II'/ 

Water After Each Flltsh 

CletlliS amI Deodorizes With Every FIII.tll 

Helps Keep Your 7bllet Bowl Fresh (fIld Clelll! 

Reco'!J.P'endetl for freqllently flushed flIii<!ls 

J91Ct (germs)(bacteria) for over I mOlllh 

IJJIlf E, coli 

!)NfS Staphylococcus aureus (stllp/t) 

!JiiIfSllimcllIellu choleraesuis (.wlmollellll) 

~ EnterococClls /aec:a/ls (strep) 

~ PSl!lIr/omonos (lcnlginosa !Jlfs common household (genns)(bllcterill) 

, ~ bathroom (germs)(bacteria) JiIfi many nJol'"olllsing (germs)(bacU'rill/ 

Active Ingredients: 

1,3.dicbloro·5,5~dimcthylhydantoin 52.7% 

I ,3~dichloro.5~ethyl~5·methylhytlantoin 10.5% 

Inert Ingredients: 36.8% 

TOTAL: 100.0% 

Minimum Available Chlorine 44,2% 

KEEP OUT OF REACH OF CHILDREN 

DANGER 

EPA Registration No. 6836-

EPA Establishment No. 6836·PA-01 

Net Weigbt ••...... " ...... 50 grams 

ManufnChlred by: 

LONZA Inc .• 17·17 Route 208. Fair Lawn, NJ 07410 

""X;<>: iv;:; hi1 

';!'iJ, 

" ':C, )IF::;, 

;;&2. i.- ;J .. -, q 

; JrOO 

. ,--_. 

Page. I -----"'-,,- "",.. land ( )= 

,., 

De'a 

--~ 

altemativelintelclmngnble 

... ~ . 

language • 

-------_ .. _---------

When used as directed, Dantochlor --TBS·3 will sauiti7.e 

toilet bowl water, keeping it clean, clellr and free of odor. 

Dantochlor TBS·3 gives the effectiveness of chi aline 

without the chlorine odor, 

Dantochlor 'IDS-3 sanitizcs toilet bowl water by ~ 

99,9% of all (genns)(bactcria) witbin 15 minutes aner 

each flush. Each tablet saniti .. .es for one month. EliJ'.tl.iM1es 

99,9% of (geans}{bacteria) within 15 minutes alier each 

flush. 

Removc taok cover ami cut open package. 

DIRECTIONS FOR USE 

It is a violation ofFedcral Law to use tbis prolluct ill a 

manuer inconsistent with its labeling. 

To Sanitize, Clean, and Deodorize: 

t, Clean toilet bowl thoronghly including nnder Ihe rim. 

2. Remove toilet tank top. Hold plastic poucb away from 

face. Cut pouch open with scissors on dotted lincs, Do 

not tonch tablet. 

3. Flush toilet. Before tallk refills, hold plastic pouch 

over tank and drop only Lhe Dantochlor TBS·3 litblel 

into the right rear comer of the lank. (See diagram) 

Discard plllSlie pouch and wash hands UlOroughly. 

4. No removal necessary. Each tablet sanitizes for one 

month. When tablct hns dissolved, replace wilh a new 

tablet. Producl should only be used in 8 toilet tbnt is 

nushed regularly. 

STORAGE AND DISPOSAL 

Store in original container in arellS inaccessible to small 

children in a cool, dIy, well~ventilated area. Do 1I0t store 

at elevated temperatures. Discard empty container in trllsh< 

Qu<stiom? Common.? C.n (Wert "I<pbooe numbm' h=) 

This producl contains no phosphates or phosphorous 

compounds, No mess. Docs not hann plumbing or septic 

tanks. Concentrated. Leaves bowl 99.9% (genn)(bncteria) 

rree . 

16 

~J 
, 

, 

o 

(OpT/aNAL MA.RKET/NO LANGUA.GE); I 

• ..-::-flllttmcmmi (Vot. 4 <: c e f'fr:.rb L 

• CHLORiNE CLEAR with Bleach 

• Sanitizing Formula ClealU &: Deodorizes 

• CletJlU & Deodorizes With Bleach 

• Keeps Waler Cryslal Clear 

• Easy To Use - Just Drop In Tank 

• f;ifG 99.9% Of (Germs)(Bacteria) for (life month! In Toilet 

Bowl W_ After &ch Flush 

• Not HarmjiJllOPlumbingorSeplic~tems 

• Leaves bowl saniJary 

• Makes cleaning easy 

• CcnJro& odtJr..cousing (gemu){bacIerla) in the hoM »aM 

• Omtro/r Ihe growth of (gerou)(bacJrrio) tIrat cause """" 

• am .... """" caused by odor-cawing (gerou)(bacJrrio) 

• FigJw tough staitu 

• Keeps your lOiIet bowl stain-free 

• Continuous real bleach ckoningand deodorizing 

• NoMesSilitOnk 

• Bleach' ckmiing 

• FOI'coloredtoile13 "-q ••.•.•• ,", 

0 0 

0 0 0 0 

0 0 0 0 

0 0 0 0 

0 0 0 0 

0 0 

o 0 

o 0 

.. 0 

o 0 

o 0 

o 

0 

0 

y(; ~. 

1lt~LoiiW~' flfti/) I 1, ~ooo fI"dor IhUl'i1dOl1!l!lweott?fde. FlnttttCid~ IIlId ".:-,..,.: .'" """'dod Ioruk.~~_," ~1l.O<Iorb.i~iY 

(,836-;(7') 

•••• 

o 0 

o. 0 

•• •• o 0 0 

••••• 

'" 0 .. 0 

0 0 •• 0 0 0 0 • 0 0 0 0 0 0 0 0 0 0 • 

,'OJ 

'/ 

(fY'flie~ 

be,o,J), 

erR eft l'j 

Sft-N; + ;-zrr"'" 

f2-e-cU~;1-t ~ !C?/1teA 

• 

,'rd, : 

,,"'l' " , ,.! ,"'. 

"".,,' " 

""'~ ; 

2J23JOO Paael "M""" , 

,,:;' n 

'", ' , .' '"'"-''''' ( 

~ 

J aDd ( )= Dl!DOtes altemalivclinlerchaogabJe languago:: • 
• 

• 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

March 02, 2000 OFACEOF 

PREVENTION, ptSTlClOES AND 

TOXIC Sl.l6SfANCES 

MEMORANDUM 

Subject: 

From: 

Efficacy and Label Review for "DANTOCHLOR TBS-3" 

EPA Reg. No(s) 6836-ETO 

Case No. 065210 

DP Barcode: D262243 V' / I j. 

Bruce H. Mann (~(P,,!- tiW't'~ Efficacy Evaluation Team C 

Product Science Branch 

Antimicrobial Division (7510C) 

To: Robert Brennis PM 32/ Thomas Luminello 

Regulatory Management Branch \I 

Antimicrobial Division (7510C) 

Thru: ;4,-,-.1

7

, Emily Mitchell M.S., Team Leader f..£7/~ 

Efficacy Evaluation Team 

ProdUct Science Branch 

Antimicrobial Division (7510C) 

Michele E. Wingfield, Chief 

Product Science Branch 

Antimicrobial Division (7510C) 

Applicant: Lonza, Inc., 

17-17 Route 208 

Fair Lawn, NJ 07410 

Formulation From Label 

Active Ingredient<s) 

1,3-dichloroM5, 5 dimethylhydantion .................................... ., ........... . 

1 ,3-dichloro-5-e1hyl-5-methylhydanton ............................................ .. 

Inert Ingredient (5) , ............. " .. , .......................... H ••••••••••••••••••••• , ••••• 

Total ......................................................................................... .. 

%bywt 

52.70 

10.50 

36.80 

100.00 

InlolTKll Addn:iu: (URL) • I)ttp:llwNw.epagov 

RoeyckdlRocyel4bllll • Prilltad wIIf1 v~ 0iI8Im!d ifllil: 00 Recyd&d P/¢lOf (Mlnlmllm 25% PtI$t(:OOmmw) 1 8 
- ---- - -------

BACKGROUND: 

The subject product "DANTOCHLOR TBS-3" (EPA Reg. No. 6836-ETO), is a new 

application for an end-use product which is being proposed for use as a toilet bowl in-tank 

sanitizer. The product is being proposed for use in homes, schools, and hospitals. 

The tablets used in the study are listed and reported as Oantochlor TBS 3 (reported an 

initial weight of approximately 50 grams). 

The generated and submitted efficacy data were developed by a simulated test 

method/protocol utilizing the basic efficacy data requirements for testing in-tank sanitizers as 

specified in the Agency enclosure (In-Tank Sanitizers for Sanitization Products of Toilet Bowl 

Water). In conjunction with the efficacy data developed by the Agency endosure, the studies 

included neutralization control challenge data to show that the test product in the toilet bowl 

water was adequately neutralized. Neutralization toxicity data also were included to show that 

the neutralizer used in the study was not toxic to the test microorganisms. The studies also 

included reports to determine the native microflora in toilet bowl water to compared to the 

microflora level added for the in4ank sanitization studies. 

e To validate the product effectiveness as an in-tank sanitizer, a reduction of each test 

microorganism must show at least a 99.9% reduction over the zero the "O-time" control and the 

parallel untreated inoculated control. 

• 

The current submission contains required test microorganisms, additional test 

microorganisms, applicable control studies in support of this claim, and a proposed label 

pinpunched 02-24-2000. All data reports and labeling comments are sUmmarized below, 

(MRID No. 450008-02) 

RECOMMENDATIONS: 

EFFICACY SUPPORTED BY THE SU6BMITTED DATA: 

The submitted microbiological efficacy developed by the In-Tank Sanitization Test 

Method appears to be adequate and satisfactory in demonstrating in reducing the test 

microorganisms Enterococcus faecalis, Salmonella choJeraesu;s, Staphylococcus aureus, 

Escherichia coli and Pseudomonas aeruginosa at least 99.9% over the "011 time control and 

over the parallel untreated inoculated control at contact times of 1 minute, 15 minutes, and 30 

minutes when exposed to a minimum active level of total halogen (as CI2)(mglliter). The 

submitted microbiological data showed that toilets which were standardized to reflect 6 liters +/-

0.2 liters of water per flush with 50 gram tablet (cold water 12.0°C) (wann water 25°C) resulted 

in total average of 33 days. 

The data submitted to determine the minimum use concentration (ppm, milligramlliter) 

for a 30 minute contact time was found to be 1.36 ppm of total halogen for Ps. aeruginosa for 

E.faecalis. for S. aureus, for E. coli and for S. cho/eraesu;s was required to show a 99.9% 

reduction of test microorganisms, 

19 

--------------~---... 
• 

• 

For a 15 minute contact time, 1.44 ppm of total halogen was required showed a 99.9% 

reduction for E faeca/is, for S. choJeraesuis and for E. coli was required to demonstrate a 

99.9% reduction. 

For S. aureus and for Ps aoruginosa, at a 15 minute contact time, a halogen level of 

1.47ppm of product was required to demonstrate a 99.9% reduction. 

For a 1 minute contact time, a total halogen level 2.80 was required to show at least a 

99.9% reduction for S. aureus and E. coli. 

For S. choleraesuis. a halogen level of 2.96 ppm or total halgen was required to show at 

least a 99.9% reduction for a 1 minute contact time. 

For E faecalis and Ps.aeruginosa, at the 1 minute contact time, the minimum use 

concentration could not be determined. 

Based on the submitted sanitizing data for the required test microorganisms and for 

additional test microorganisms indicated above, product effectiveness as in-tank sanitizer was 

established and is considered acceptable as an in-tank sanitizer for toilet bowl water . 

EFFICACY NOT SUPPORTED BY THE SUBMITTED DATA: 

Based on the submitted data for Candida albicans, a minimum use concentration 

greater than 2.96 ppm total halogen was required and needed at a 1 minute contact time and 

greater than 2.00 ppm at 15 minutes and at 30 minutes contact times! as such, a sufficient kill 

was not demonstrated at any of the concentrations tested to show a 99.9% reduction. Since a 

sufficient kill was not obtained, product longevity could not be determined for Candida albicans. 

labeling Comments: 

The comments are applicable for the proposed label listed as "Dantobrom T88-3 (EPA 

Reg. No. 6836-ETO) pinpunched 02-24-2000 .. 

The use of the phrase "kills 99.9% of germs is unacceptable since it infers a higher level of 

activity than the product proposed level as an in-tank sanitizer. Claims for killing action 

implicates a disinfectant level of activity which are not acceptable and are not supported by the 

accepted efficacy in-tank sanitizing data refer to attachment #1). 

1. On the upper center panel, item #4, revise "kills 99.9% of (germs)(bacteria) in tiolet bowl 

water after each flush .. " to read "Reduces 99.9% of a number of many (germs) 

(bacteria) in toilet bowl water after each flush". 

2. On the middle center panel. revise "kills (germs)(bacteria) for over 1 month to read 

"reduces(many germs)(many bacteria) over 1 month". 

3. On the center panel, revise "kills IE. coli! to read "Reduces Escherichia call', 

20 
• 

• 

4. 

5. 

6. 

7. 

8. 

9. 

10 . 

11. 

12. 

On the center panel, revise "kills Staphylococcus aureus (Staphr to read "Reduces 

Staphylococcus aureus (stapht. 

On the center panel, revise "Kills Salmonella cho/eraesuis (Salmonella) to read 

'Reduces Salmonella choleraesuis (salmonella)". 

On the center panel, revise "Kills Enterococcus taeca/is (Strep) to read "Reduces 

Enterococcus faeca/is (Strep). 

On the center, revise "Kills Pseudomonas aeruginosa" to read "Reduces Pseudomonas 

aeruginosa" 

On the center panel, revise "Kills common household (germs)(bacteria) to read 

"Reduces common house (germs)(bacteria)". 

On the center panel. revise "kills bathroom (germs)(bacteria) to read "Reduces 

bathroom (germs)(bacteria). 

Revise "Kills many odor-causing (germs)(bacteria) to read "Reduces many odor-causing 

(germs)(bacteria). 

On the upper right panel, revise " ... killing 99.9% of all (germs)(bacteria) within 15 

minutes ... " to read " ... reduces 99.9% of many (germs)(bacteria) within 15 minutes"." 

On the upper right panel. revise "Eliminates 99.9% of (germs)(bacteria) within 15 

minutes after each flush" to read "Reduces 99.9% of many (germs)(bacteria) within 15 

minutes after each flush." The term "eliminate" is not applicable for this use pattern. 

The product highest level of activity is only as a sanitizer. If the product was at a 

disinfection level, then the use of the term "eliminate" would be applicable. 

Labeling Comments for Optional Marketing Language: 

1 . As per Pesticide Assessment Guidelines, Subdivision H, it is unacceptable to use a 

term that infers a higher level of activity than what the the product data supports. Since 

the product only supports a level of activity at the sanitization level, the use of the term 

antibacterial is considered unacceptable. 

2. Revise the wordings "kills 99.9% of (Germs)(Bacteria) for one month in Toilet Bowl 

Water After Each Flush" to read "Reduces 99.9% of many (Germs)(Bacteria) for one 

month in Toilet Bowl Water After each Flush". 

3. Revise "Controls odor-causing (germs)(bacteria) in the bowl water" to read "Controls 

odors produced by many odor-causing (germs)(bacteria) in the bowl water". 

4. Revise "Controls the growth of (germs)(bacteria) that cause odors" to read "Controls the 

growth of many (germs)(bacteria) that cause odors". 

21 
• 

• 

EFFICACY DATA REQUIREMENTS 

In-Tank Sanitizer Products 

The basic elements to be incorporated into the protocol designed for testing", 

automatically dispensed in-tank products as sanitizers against pathogenic ' 

microorganisms in toilet bowl water are outlined. below! 

A. Preliminary Simulated-Use Tests 

. 1. The use-life of the in-tank product must be documented for three 

product sample.s, each in a separate toilet, under the following 

conditions simulating actual usage: 

2. 

•• 

l>. 

ltXIl flushes (dispensation of the dosage)/dayrxl

' weeks (duration:~' 

of effectiveness) with a non-chlorinated water supply at 2S-30oC· 

(the warm water tempera~.xtreme in summer). ,\'r 

Repeat of <a> above with a non-chlorinated water supply at 

lo-lSoC (the cold wat~ temperature extreme in winter) • 

• 

At periodic intervals during the testing indicated above •. the 

bowl vater must be analyzed to demonstrate the pH and 'concentration " 

of the active ingredient (9).. 7 

B. Laboratory Efficacy Tests 

1. BacteriologicaL assays must be conducted on neutralized treated 

untruted sampies bY"standard plating procedures employing: 

•• 

b. 

c. 

Samples of the residual·boVl water from three toilets (at the 

Ulinimal use concentration) and corresponding untreated control 

samples from three toilets at lo-l50 C (the most stringent water:, 

temperature for demonstrating efficacy). -,~ .. 

< * Representative pathogenic Gram-positive and Gr~negative bacteria 

(e.g., Streptococcus faecalis, Salmonella choleraesuis) with an· 

inoculum of at least lO4 .colony-forming units per ml. 

A minimum of three exposure intervals. in addition to a "o-timet

! 

• control. 

2. For sanitization claims, the reduction of each c.est microorganism --",-

fIlUSt be at least 99.9% over the 1I0:"t ime" control and the parallel 

untreated inoculated control. 

, 

( rr: . e; 22 
/ I 1/ I ' .. In 0 t' .• ,A,. {;' N 

~. 

FI Ii "/" pn. -, . l.u! 

, j 

Proposed Clai:ns 

~. Onacceptable Clai~ 

The claims ftKills odor-causinq bacteria" and ~Kills bacteria that 

cause odorsft indicate a disinfectant level of antimicrobial 

activity and vould not be acceptable for the proposed use pattern 

for sanitization of toilet bowl water. -, -- ----. 

3. Qualified Claims 

---!".:-"It'!'~"';cJc!a~::rin9 to cle.nine;: .... ithout brushing required 

qualification to be acceptable and compatible ~1th the 

fOllowinq required directions for use. To assure that the 

product will be effective as a sanit1:er~ the use directions 

must include instructions for the removal of occasional 

stains like bevel movement stain, vomit or other IDatter 

deposited on the toilet bowl'surface. !Qr- those occasional 

instances, cleaning instruetions such as -Flush, brush the 

howl surfaces with bowl water, then flush again- would be 

~ adequate it this product alone is to be reeomaended for such 

eleaning. Instruetions may a150 include the addition of a 

eleaning agent, compaticle wi~b the product, to aid in the 

removal of these soil deposits. ; 

> 

• 

2. For the elaim of effectivenes. for up to "2" months to b4!" 

meaningful. the use direetions must indieate bow the user 

will determine this claimed duration of produet effeetiveness. 

3. Claims for killing Action connote disihfectant activity, i.e. 

complete elimination of a finite viable microbial. popul.aUcm. 

Effieacy claims sueb as ·sanitize. toilet bowl water,- -reduces 

tbe number of geras in the: toilet bpwl water by 99~9' after eaeh flush." 

"significantly reduees the nurober of ger_ in. the toil.t. bOwl 

water- wou.ld be appropriate for the pattern of use int.ndea for 

this product • 

-' ----- C. Non-Elealth-Ralated 0.. -... 

--- '%! Chis product is ~SlY recommended to sanitize and control 

odor-eausing bacteria, as all the proposed efficacy claims indicate 

except the unqualified elaim "sanitizes toilet bowl water-, no 

effieacy data will be required as explained in the DIS/TSS-16 

enclosure. 

;! .... 

23 
• 

St!BJECT: PRODUCT CHEMISTRY REVIEW - Antilllicrobial, Division 

DP Barcode D264224 Reg. No. or File Symbol: 6836-10"1"0 

Manufacturing-Use r J or End-Usc Product [X] Case #-

TO: Robert Brenniiffhomas LumincJlo 

PM Team No.n 

fROM: 

THRU: 

TURU: 

Anna Skapars, Chemist 

Citemistry-Toxicology Team (CTT) 

Product Science Branch (PSB) 

Karen Hicks, TeaJU Leader 

ChcmistrynQxico!ogy Team (CIT) 

Product Scicllce Branch (I'SB) 

Michele E. Wingfield_ Branch Chief 

Product Science Branch (PSB) 

SUMMARY OF INFOI~MATI()N REVIEWED ANQ fiNDINGS 

BACKGROUND: 

The regjstrant is resubmitting a Confidential Statement of Formuln which lists the correct 

concentmtion for the source product for the active ingredients, 

FINDINGS: 

The Confidential Statement ofFonuula daled 113/00 is in compliance wilh 40 CFR; Pttrt 

158.175 and I'R Notice 91-2. The CSf agrees with the p.roposcd label aud is aceepmble. 

e The revised Confidential Stalement of Formula dared 3/17/00 is in compliance \vith 40 

CFR~ Pan 158.175 and PR Notice 91 ~2. it agrees- with the label am.I is acceptable. 

24 
• 

• 

LEWIS & 

HARRISON 

Con,ult,ntt In Governmont At1.lrs 

February 24 2000 

122: C Street, N.W., Suite 740 

Washington, D.C. 2000t 

telephone 202.393.3903 

fax 202.393.3906 

U.S. EnVlronmental Protection Agency 

Office of Pesticide Programs 

Antimicrobials Division 

Document Processing Desk (BRENNtS] 

Room 258, Crystal Mall 2 

1921 Jefie:-son Davis Highway 

Arlington, VA 22202 

ATTENTION: Robert Brennis 

SUBJECT: 

Product Manager. Team 32 

LONZA, Inc. 

Dantochlor TBS~3 (EPA File Symbol 6836-ETO ) 

Submission of COlTected Labels for Registration 

Dear Mr. SrennlS' 

HAND DELIVERED 

As agent fOi" LONZA. Inc. ("Lonza"), we are submitting corrected labets In support of the application for 

registration of the new end-use pesticide product. Dantochlor TBS..J (EPA File Symbol 683G-ETC). The 

labets that were submitted with the origrnal apP!lcation package contain a few typographical errors and 

omissions. Themfore, we request that the enclosed labels, dated February 23, :WOO, be reviewed in lieu 

of the prevIously submitted ones. 

Enclosed, please find the following documents: 

1} Application for Pesticide (oPP ID. 256772), to which is attached a copy of the Child-Resistant 

Par.kagmg Certiflcatir,n end lettel from LonLa authorizing LeWIS & Harrison to act as Its agent: a'ld, 

2'1 FivE'! (!:') copies of the corrected product labeling. dated Februn:y 23,2000 . 

It you h.'J'Jf~ mly questions ~OOlit tne enclosed submission. please contact Ellot Harrison or me at 202·393-

3903, 

Sil'lcEleiy, 

_~~~t. 

We~dy A. McCombie 

Agent for. 

LONZA. Inc. 

WAM/wm 

Enr:lo!:;,.HcS 

CC; RUih Trager (LONZA, Inc.) 

Oat1lochlor TBS·3 tEPA File Symbol 683S-ETO) 

••••• • 

• •• • • 

•••••• • • •• 

•• • •• • 

• •• 

• 

•• • •• • • •• 

• ••• 

• •• ••• • ••• • • ••••• • 

•••• • • •••• Page 1 of~ ••• 

• • •••• 

25 
, , 

..,.. EPA United States o Registration opp Identifier Number 

Or Environmental Protection Agency o Amendment 256772 

Washington, OC 20460 tx1~ 

for Pesticide· Seetfon I 

:;:;";A:in~:I' ",mbe, ~ EPA I , 

~m;;f ~m32 t21 Nonlt o RestJiclcd 

N, G. !w I '3(cj(3) LONZA. tnc. (bIll), my product Is similar or idcnticalln composition and I 

17-17, Route 208 to: 

F'''~ EPA Reg. No. 

'm 

Product Name 

Section -II 

A~nt - E'Iq)toln belOW fll'llli printed lilbels m '"pomlC 1:0-~ ~lWr dated 

~ission In ~Il!'e to Agency !citer dawd -Me 100' ApoilCaboFl 

i 0."". 

lif u •• . necessary (For , land 111.) 

Submission of Corrected Product Labels for Registration - To Be Reviewed in 

Place of Previously Submitted Labels 

Seelion -III 

~ .~- 2 

Yes' 

~~s Yes .,.,. 

No IN> P ..... 

·Certification must Ie,' No .... 'ft' No .., , Go" cot'!tlJiner container Pape: 

11tmmed I I Other(~) 

, ~ ''''"' 1'1'!~'" Ui\lql o COn1Smar 

50 gram« i 0,"""0"" , .""''''' I" h Lobe' I , 0 

, 

Section-IV 

,. Coo,,,, Po'" 

:= I. to 

~~cs~iNW' . I T>Jo 

, 

o . ,... '",W7 A .. Inc. ~ ,... stalDmillllbl j hliw made on th13 fom:;~~d- , .,.: ~~?' . tak-c ' pt.IQlsfl3hlo 

ItwzmtQ aM 

by 

1!Uf(, 

lim: O1lmPlrnmnwntor 

r •• cl.lrate MId enmptm( Ix.>ti,.:. I ~f h ;' 

..... 12 ." ~>.~'b, /' I ' 111~ :::: 

• 

Agent for LONZA. Inc. [. •••• _..:;-,.r" '~_+," \"~ ~~_ 

• 

j. T~N"". 15. 0 • ,

• • •• t-

• • A McCombte. Lewis & Hamson 02/2412000 . ~ .. •••• .,., Fann .51.;, w,,, ... 26 
" . .t.:. .. , 

Urtite/J Slew. i- Registration ...... " oEPA environmental Protection Agency _ Amendment r c: ~ -" ,>\ 

WAlihingtOn, DC :20400 Other 'J ,) ( / :::: 

, for I- I 

2. EPA 3, ~ ClMlt4fwaUon 

4. C~lItWlPtodlWl IU.III'M) PM. O""M o Ru.lrir;led 

S. NfII1'\lf !iIOO Addr." of ApplIcant Ilncluth ZIP Cede} 6. Expedfted Review. 10 at«lfdaoce with FIFAA Sectioo 3(cIl3} 

:~blm.'·my product is aimilal' Of ldul'llicai in compaslliJni-Und 'labeling 

to~ 

EPA Reo. No. 

n CIr.ck if #nll k ., (lflW mirklnS , lU, 

, - II 

o Amondnwn1:., fxplllln ~w-. E Final f'rinloo liJbiri.ln rfl411<'1fW!!: f!J 

AgiInC-y lajt~ dlltlid D Rc:t.l.lbmalmm in fCt;lonllG to Age.I'Id.Y hUIIH tllIl.4 _ ~Ma T(jo~ Appftcltlil1l1, 

~ , ,'''''',,,.,,,,,, [ OtMt - Elq'llwn b416W. 

, t.1l'll; Mdith~nflf pOQ(I(';:1 ,I IWCQ!I&my, IFo, !!-!lotlon I tiM 1hHliion II,., 

, -.l!!. , ,. M .. "W "'" , •• ,',,' wm .. 

Chikl·R,ulIshmt PaeloIO'"'" Urnt plt(lko~n" ~_r Solll~Q Perokaolng BY"- Y .. - V •• '~Co;'":' N. fl. 

......., 

N. Gltltt 

~~. fflU.' 

No. Pit! ,~-y"' No. f,lfJr 

WaC c:ontlluuu' w,. 'M"'- "-

Qfhflf 1$p~M 

1 

- ~ ~ 

o Coruaitlllr 

I.", ::3 ~. '.' ':"'!" . 

6, MlnlW' 11\ Whlch labMl$ Affixod to,Produat Eli Donw 

.-IV 

1.' "'fI, 

Nm", "" TotfWiwM No. tlllclud", Ar"-'l Cv4/JI 

C.rtlflcalffm 

I lIlAtmnullts I have- made on 1hit torm,md.u .Ultdmwnu IMAto, 111'. UUti, /lCCumta lind ~t. 

I ~ ~ knOwingiV fal .. or mlatoaoll'9 lIU1;toment may br: punbdu.d:w1'I by HM Of lmprhlOnmeflt ot • : •• I Sjampod) law, ....... • •• 

3. TId. •• • ••• • ••••• . .... • • ••••• • 

•••• 

•• T,.,...N_ '~D'" • • •••• 

•••• • till •• • 

.... 

EPA I _ .. ' . .,."., 

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

PAPERWORK REDUCTION ACT NOTICE apd INSTRUCTIONS 

PApfRWORK REDUCTION ACT NOTICE; Publtc roponing burdon for this collection of information Is ,.tim_ted to overogo 0.85 hour por 

rnponso, Including time for reviewino instructions, searching oxisting da18 wurcee. ~rlng and maintaining. tho dote nHded. and compl,tlnt and 

rovi.wlno 1M oollaetlon of information. S.nd ~"ts IOge«fmg tmi burden osrtfmatO Of iinf otfttr ..,.ot of lhi. oollection of information, iMlud"mg 

suglJUtion. for roduoinQ- thi. burden. to Chief, Info'nnetion 'Poliev Stanch. 111361. U,S. ErWironmllnt.i ProtCl.-r;:tion Aoern;y. 401 M Str .. t, sIN.' , 

Wuhington. DC 20460. 

INSIRUCTIONS; Thi. form is to bo Ulled for all opprreotiom for now regisuotion, -lind 1.1.0 rereglsuadon, amendment, ro.wmrmon. to appllcouon, 

for notlfiootlontl. fil'lUl printed labofing. rorogistral;cn. ate. In ordor to prOCG" flO application tOf a now flIgi$trQtion submitted on tlit form. the 

following m.t.rlal muot accompony the application: 

1. Certification' with ROllpoct to CItation of Ooto IEPA Form 857()'291. IIf not oxemptad by 40 CFR 152.81 (h114!!; 

2. Confidentllll St.tetn9nt of FomWl. IEPA Form 8570·4): 

3. Formulatof'. Ex.mptfon Statement (EPA Form 857Q-27); 

4, Five cop1oa of draft l&boling; 

5. Thr.e copies of any daw submitted; 

6. Authorize1ian letter wiaNt appllcoble: 

7. Mauicu whine applIcable. 

Sulunifll1M of LabennQ - Ltlb1lllng should fint be lWbmlttlNt In the fonn of dtoft labol. with oll4(1pJlcation. fot new reQlstrlltion. Such dtlfft label. <may ~ 

In the form of typlld labol text on 8.5 x 11 If\!:h paper'for wbml"ron or a mookup of tho ptopoHdI4bet. If prepared for mockup, It .hoUki bo 

cono:tructed In II wily a, to facillrat •• toroge In lin 8.5 X. 11 ,mch file. Mockup Illbol. ~gnirlccntly Imallllr than 2.5 X 11 1m:ho •• hould tMt mounted on 8.5 

x 11 Inch paper for lubminlon. 

Submimon of Data· Dllta submitted in support of this. appHdutIon mullt be subm/tted in JllX:Ofd8M8 with PR Notice- 86-5, 

SPECIFIC INSTRUCTIONS; Plauo road tho instructions listed below before comp/ating this appllcatron. First determiM the type of nlglltraa 

lI(:.tion, l18tlll:l In Stock A. for whioh you are submitting this 1IPprrcatien. For appIice1ions .ubmittod in connoctllln with' N.w Regl'tration-llcticns. s~ 

I. m. and IV must be oomplatod by tha appllcllnt. For tlppDcalloM llUbmitted In connection witll amended reroglstretion actions. resubmill$rons, 

notificetrons, rerugistretions, otc., Sections I. I~ lind IV must bll coir!pluted by tha oppUcont, 

Btoek A ~ Chack the ilppropriate ec.don for which you aftt submlttlng this form. 

SECTIQN I· This Mction I'f\U$t be compflltad, n $ppRoable, for on registration actlons. 

1. CompenylPtodtlct Number· In!!.llft your Company Number. 11 OIW on been _good by EPA.. TN. number may have been mgMd to you II' e 

basic registrant. a dI,tributor. or os on estab".hmont. If your product Is- tcgistorCd. meort tho Product Number. 

2. EPA Product MlJ,nOget-lf known, nil In the ngma -lind PM number of the EPA PrlJd\jct Manager. 

3. Ptop_d Cf_lflcation ~ Spooify the propoud clauificatloll of this product, 

4. Product NelM ~ Enter tho oomplete product nllm6 of tNs pestioldo as It wlM appllar on the label. Tho rnIImt must be Sp4(:irlc 10 this produot only. 

Ouplicalrlln of numlla n. not permitted Ctmong produoa ot the aamu compony. 00 mit include any brond nurrla 01 clH'Opany linD do.tgnations. 

5. Nema and Add_ of AppllQOnt~-TM ntllrnl of the f11'n'! orj:)orson ond OOdrw.shown In yOl.lr ewIleetion ill the panon or firm to whom tk$ 

regmtration wm be jS$ued, II you Of 0 .ecting in bohnlf Qf another porty, you must oubmil suthorir.tion frem that party to ~t (or \hom in rogl.:tfGtion 

motters-o An applicant not rHkrrno in thOe Unitod Stat'"' must have an authorl;od agent residing In tho Vnitud Stotu; to act for them in fill 

registrntion matters. Tho nlltm1 and oomp/<lW: meilmg add,.!!;, of such In .Q4nr must ~.n't' th(s sppUcatioll. 

6. Exp.dlta4 RaYklw ~ FlFRA. saction ;3 Ic) 3 fBI provldt!= for expedited revlow of sPPHe.tions tor reglstrotion. Of' llmaMmlltlW- to existing regillUetJol\S. 

that IH, $i/Tlilor or Identioal to other posticido produotll thJil:t ant eurrently registerad with the EPA.. In onlor fot YDUr tlppfieooon to ba' eliglbhdor 

axpediteIJ relliaw, you,mult p"a4de us with the EPA Reglstr4tion NumU.:tr lind prtldU(lt name of tfut product vW bell&<ie r. similar- to or !domled,to 

your product. The product must be s!miler Of IdentlcalJIl'lwth fomwletlon liM labeled uses. e 

SECTION If • Thig •• ction i1Watbe complated (01' all oppllcatlotltl submitad to .emend tho- registration onIV of JiI currentlv UgiSWled pr(l(fuct 

IAmllndmentl.Jor" tosUbmiscion in «Iltponsii to "''' Age-ocy l(ltt8t, fer notJfJeatlonli to tho Anancy, for th& lI'ubml$Sion of final: printed labeling. for 

rllreglstnnion and for any oth.r action thet plllains to e ;meclfle EPA-rooh;-rllf\id prtlduet: This aactlon Is.!l2!!!I: Ja used for 8 ntlW Jilpp/ie4t10n for 

rogi:5tl'sritm. 

1. Subject 01 .ubmb$/on ~ Chock tim oppllcabfc blook em:J provide tho Agency Icttor date if upproprlatD. Provido ill blref tmplanation of tho pUlpo,,,,Iu) 

lor the lIubml,sion, such a6 ~the add/tlon of.- ,Itc. pest or crop fspocify}~; "om&~ thO Confidential Stetumtnt of Formula bV .•• -; "r8registration 

#ubmiuion", "oencrall8b1l1 revisjon of Use dlroctions. ~ AUael'! I! sspilrat& paOtl if addltion31 :paca 11 needed. 

SECTION III {Packaging and Container Information} ~ This Section must ba Cdmplottd for all appllcatioM submitted in eonMction wIth naw 

logistriltion er 6\'lPHcable lIme-ndmontt-_ 

1. Type of PackaoLne ·.~heck tho eppropriuto block. if your product wm be packDiJed 10 the indIcated paokaging types. 

Indicata the Nt1 o~ the indlviduel packets end numbar per rotal! container. 

2. Type of Retalt ~I~or ~ lodrcatl!:tYPe of container in which product will be marketed. 

3_ Location of Net c!'oownk ~ lrGl1iGtt: Fha 10Clltion of the nat contllntf- Infarmetren f~rvour produe1. 

4. Siule} of Ro~11nu ~ !peclfY'ho mrt contents of 611 rotail 4Ont4lnef$ for your pr'oduot. 

5. Loclltlrm of u .. ~a"etion& -~t~e I,ocotlen Qf ths: us. dirllctlOM Jor your produet. 

6. Mllrnar In whkh~~ Is affixWo'lo ploduct ~ Indicated tho method product lobol is eUJiI(:hod to rotan contllinur. 

•••• • •••• • • SECTION tV ICol\kll);t Point} ~ "RMoo$lrI);tion !l\IJst be completed for aU epplicationll- for Registration actions. I. •.• rww products regieu.tion, 

IHUbmislion. ~f'M\-tCOt'lreregis-mldon. et~_ 

• • 

1-5. SoIf.elq)faootory""· 

6. EPA Ville Onl,y~··· • 

•••• 
• 

• 

• 

CERTIFICATION OF CHILD-RESISTANT PACKAGING 

PRODUCT NAME: 

EPA REG. NO.: 

REGISTRANT NAME & ADDRESS: 

Dantochlor TBS-3 . 

8836-____ (not yet assigned) 

LONZAlnc. 

17-17. Route 208 

Fair Lawn, NJ 07410 

CERTIFICATION STATEMENT: [NOTE: Although Lonzalnc. will be the registrant for 

Dantoehler TBS-3, ft will not distribute the product. 

CurrenUy Lonza Inc. Is in the process of selecting the 

disllibu/or(s) for Dantoehlor TBS-3. Once the 

disl!ibu/or(s) have been selected, Lonza will submit to 

the Agency informa"on on the type of package /hat will 

be used for Dantoehlor TBS-3and fts ASTM designation.] 

I certify that the packaging that will be used for this 

product meets the standards of 40 CFR 157.32. 

including the revised standards in 16 CFR §1700.15(b), 

when tested by the revised testing procedures in 60 FR 

37710 (July 21,1995). 

SIGNATURE OF AUTHORIZED 

AGENT: 

NAME OF AUTHORIZED AGENT: 

TITLE OF AUTHORIZED AGENT: 

DATE: 

Wendy A. McCombie. Lewis & Harrison. LLC 

Company Agent for LONZA Inc. 

.. . •• • • •• 

•••••• • •• 

• • 

•••• •• • • •• 

••••• • • ••••• 

• 

•• • •• • 

• •• 

., .-

• •••• 

• 

• ••• 

• . • , ., 

•••• • • •••• 

29 
• 

t.ONZAjnc. 

CO!PQlaW Headqunnoro 

17~17 Route: 208 

Fa" l.a'1:l'~J2'¥.41~f' 

• 

Mr. Stephen lohnson., Director 

Registration Division 

Office ofPeslicide Programs 

U,S. Environmental Protection Agency 

Crystal Mall. Building 2 

Arlington. VA 22202 

RE: Letter of Authorization 

Dear Mr. Jobnson: 

This letter authorizes Lewis & Harrison. L.LC. of 122 C Sueel, NW. Suite 740, Washington 

D,C. 2000J, to act as an agent on behalf of the following 2 EPA Company numbers:: 

• 

Lanza I"" .. 17·17 Route 208, Fair Lawn. NJ 07410 

and 

Company number 6836 

H ~'i S Chemicalti Division. do Lanza Inc. Company number4n71 

17·17 Rom. 208. FairLawn, NJ 07410 

for all registration matters at the U.S. Environmental Protection Agency. 

If you have any questions, reel free to contact me at 1·800·777·1875. ext 2466 . 

Sincerely. 

R~lj~V Ruth Trager 

Manager. Regulatory Services 

•••••• 

• •• • • 

•••••• 

• .. • 

...... • • ...... 

Telephone 201~794-2400 .. Telex 4754539 ,. Fax 201~7!il'4~259T 

A member of the A .. L Alu.\iuisiOt:-Lonl." Gruup 

•• • •• • · .. 

• ... 

. , . · .. 

"n' • .... :. ky 

•••• 

.... . • • •••• 

30 
LEWIS & 

HARRISON 

l')Jf':SHM!,I'LW S"lti·;40 

WQ&'1inP!oo. D.C. 20001 

14;1N1WV!¥ 2ft! .$S3_1o/.J~ 

!iIlX7.0£.:m3;39W 

450008-00 

• 

• 

December 17, 1999 HAND DELIVERED 

U,S. Environmental ProtectIon Agency 

Office of Pesticide Programs 

Document Processing Desk tAPPL] 

Room 258, Crystal Mall 2 

1921 Jefferson Davis Highway 

Arlinglon, VA 22202 

ATTENTION: Robert Brennis 

Product Manager, Team 32 

SUBJECT, LaNZA, Inc. 

D.ntoe/llor rBS·3 (EPA R~g. No. 6836· t:lt' ) 

Applicatloll for Pesticide Regfstration -NQW End·Usec Product 

Dear Mr Srennis: 

As agent for LONZA, Inc. CLonzaj, we are submitting a registration application for a nCW eJ1d~us(:­

pestiCide produC!, Danto-thtor TBS·3 This product IS Intended for sanltizatton of toilet bowl water 

PI~2se note that Oantochlor 19$-3 is basically a dilution of the registered product. Dantochlo' 

TBS·2 (EPA Reg, No. 6836·263). The Dantochlor T8S-3 formulaiion is the same as that fo 

Dantochlor TBS':l_, wHh some LIst 4 Inert Ingredients .added to the comp-osU!on of the tablet. 

Product·specifte; Ghemlstry and efficacy data ate being submitled to SUPPo" the registration o~ 

Dantochlor TBS-3. For the remainIng data requirements, Lonza is relying on Ihe cite-aU methOd of 

data support to register this new product .and has issued offers of compensation to fhe companies. 

appearing on the Data Submitters' List for the subject actrve ingredients, 

Please note thaI the efficaC'j sludy (SanItIZing Properties of Product eoon in Toilel Bowl Waterl 

being submitted in support Of the regislrslion Qf DantQchlor TBS-3 Includes product .cnemlstry dau. 

cn pages 126 lhrougl1 138. Consequenlly, please forward a copy of Ihe efficacy study to the 

product chemistry reviewer We are if\c!udlng' extra cOpies of the effICacy study in this S(lhlr:il.!~i!)!' 

package for your convenIence, 

Enclosed, please find the tollowlng documents to support the reglstratlon of Dantochlor TE3S·3; 

1} Transmittal Dotument 

2) Appllcallon for Pestlcide Registration (OPP 10. 261292), to which is attached:a copy of ;tu:rChild-Resistant Packaging COltiflcatlon and letter from Lonza authorizing Le-','#,s;\ Harrison tl) 

act as Its agent; 

Pagt! t ef Z 

31 
-----------~----- . 

• 

• 

3) Two (2) copies of tile Confidential Sfatement of FonnuJa 

4) Flvit (5) copies (If jhe f)(oposed product labeiing; 

5) Cer1ifical1on with Respecllo Citation of Data fOfH1. 

6) Data Ma\lix (both Public- and Agency copIes): aM. 

7} Three (3) copies (jf each of the studIeS listed In the- attached Transmittal Document. 

jf you have any questiol)S about Ihe enclosed submission. please contact Eliot Harrison or me al 

202-393-3903. 

Sincerely, / 

~IIWendy A McCombie 

Agent for, 

LONZA, Inc, 

WAM/wm 

EnClosures 

cc: RUlh Trager (LONZA Inc.) 

. ... ~-,~.-------------
LEWIS & 

HAfUUSON 

122 C S:IM~. N.W" Su're 7JQ 

WI!~l'1lnglon. D.C, 20001 

t'l >eotKlne 2(;'2.393,3903 

fa> 202.3933905 

ConsullanlS in GowC'.nment ABair:'< 

• 

• 

SUBMISSION DATED. 

STUDY SUBMITTER 

SUBMITTED IN 

SUPPORT OF: 

EPA REGISTRATION 

NOS.: 

EPA TRANSMITTAL DOCUMENT 

12117199 

LONZA, Inc. 

17~17 Route 208 

Fait Lawn, NJ 07410 

Dantochlor 18S- 3 

DantochlotTBS~3: 6836- ETc) (notyetaS$igned) 

REGULATORY ACTION. Application for Pesticide Registration of a New End~Use Product 

STUDIES SUBMITTED 

STUDY VOLUME 1 of 2' 

Confidential Attachment. 

US EPA Guideline Series 61. 62 & 63 

(De.cemlber1,1999) by Lewis & 

15 pages with a 34-page 

MRID Number __ "'4""50"'Q"'Q"'8"OuJ _____ _ 

STUDY VOLUME 2 of 2 Sanitizing Properties of Product 80077 in Toilet Bowl Water (November 12, 

1999) by Michael W. Counts. LONZA, Inc. Research and Oevetopmt;!:nt: I,.onza 

Protocol No. SP~98070..M. Lonza Project No. HPR.oOO4; 138 pages.: 

COMPANY CONTACT: 

Dal1lochlor TBS·3 

OPPTS 810.1000 

MRID Numbec __ -'4::.50::.0::.0;c8:.:0"'2'-____ _ 

Eliot I. Harrison 

Lewis & Harrison, LtC 

122 C Street NW, Suite 740 

Washington, DC 20001 

(202) 393-3903 

Page 1 oi2 
• 

LEWIS & 

HAftftISON 

122 C Stroo1:. N,W" SUlt~ 1'10 

Waahlngkm, a.c, 20001 

l6Iopi1ono 2(l:2.30:,t3QO:J 

f.,~ 202.393',3906 

March 17, 2000 

U,s. Envfronmental Protection Agency 

Office of Pcstk:lde Programs 

Antimicrobials OIYfsjon 

Document ProcessIng Desk tSRENNISj 

Roo", 258. Crystal MaU2 

1921 Jefferson Davis Highway 

ArlIngton, VA 22202 

ATTENTION: 

SUBJEcr: 

Robert:Srennls 

ptocfuCt-:M~"agerf Team 32 

Tom Lumfnello 

Reviewor, Team 32 

LONZA. Jnc. 

Oantof;h/or TBS-3IEPA File SY'JIhol6Q36-ETO ) 

Resp01JS1l to AlllMCY Letter .Dated March 9, 2000 

SubmIssion of COTJ"lllCtecf labels for ~O!}lstratt.)n 

HAND DELIVERED 

• • • •• •••• 

• 

•• ., • . • •• 

• ••• 

• • .. ... 

• 

•••• • ... • , •••• 

• ..... • 

• 

As "'9~nt fnr LONZlt Inc, rLoncdi'). we are l'esp{lndmg to your fe~1er dated March 'ft, 2000 (oopy sitae/led] 

ragardlng the discrepancy between the ingredIent statement on the product fabel and Ihe active ingredient 

levels stated 011 the CSF for Oantocfllor TBS-3 (EPA Fffe Symbol 68J6...ETO) Please note that the 

applICation package for OantochtorTB$-3 was datad Oacembe~ 17,1999, not May 16, 1999 sslndlCated 

In your leuer, In oodition. 1 tl3Vl': checked the: ac«v~ il'l9rediert feve}s stated on the CSF that was Incruded 

In me Oeeemoer 1'!, tEi9S :application package against the label, and there does not seem to be any 

diffefaf\Cs ~n the two do:o:uments> . However, it doo$ Mem that the percenmgEls of 1.3-dk:htoro-5.s., 

d1m(11tl),lhy-cl<lntOm and 1.3-dichtofO..5-ethyl·f.-rncthylhydgnroin In Ih~ :source product. Danrochlor {EPA 

R~_ No. 6$:1c.114), We!f! ermn«Jusly Ifsted as 86.0% and 13.0% of 1M CSF_ Thts may be the source of 

itte (JffJblerr, Til!: COIT"!'CI levets nf 1.3-dich!orc.-5.5-dlmethyt!,!ydantoin and 1.3-dlChloro·5·ethyl·5~ 

@':th,1hydamoinin DanttJ"..::hkK .aH~ 31 7% 8f1U 16,1%.! haw correctoo trese W!lues for SectIon 10 at the 

CSF ilJ\d \wn (?') l;cplfj.S Of 1M revi~,d doctlmanlafe enc!cOO::I 

!Juring :JUl' teJe;:;IKlllO d<,scussit.m yesterday aftefM('if), Tom indicate<! Ihat our Fehruary 24, 2000 

submissloft oonrainfng C-Offe:;t~d ~belS tor DantochtorTBS..J had not yet been recelVed by the Team and 

(!)quest~cl 1!ltlt WI! rl!:-sutmlft the documents. Therefore, we are Including the corrected labels: from toe 

February 24. ,W{II) p~ckage v.,'ith our response. The Oantochlnr TSS-3 labers thaT were sUbmitted with the 

original ::lpt:licalton package contained a few typographical Offors and omissions We are requesting that 

the Team review Ihe enclosed Dantochlor T8S~3 l::thets dated February 23. 2000, instead of the 

prevlous!y submittM ones. 

Danlochl.,,-TOS·S {EPA I'll/< Symbel 6!J1·EfO) 

34 

• ••••• • •• • • . ... " .. • • •• .. ...... • • ••••• 
• 

• 

In addilion to the afOff::!menfioned attachment, p~ find enclo$w the- folkJwing documents: 

1) Application for Pesticide {OP? 10. 256750), to which is attached a copy or the Child-Resistanl 

Packaging Certtflcatlon and letter from Lonza authorizing Lewis & Harrison to act as its agent; 

2) Two (2) copies of the CQ!l!l<!ted CSF; and, 

3) Five (5) copies of the corrected prOduct labeling, dated February 23, 2000. 

If you have any questions about the enclosed submission, please contact Eliot Harrison or me at 202-393-

3903. 

SinCE!fely~_, _, ¥ 

.~ ~'..d.. "w /L / _ .... ~=-::r-..t-" 7,/~ 

Wendy A McCombie 

Agent for • 

LONZA, Inc_ 

WAMlwm 

Enclosures 

cc: Ruth Trager (lONZA. Inc.) 

• • · •••• " 

• . , . " . • •• 

•••• • • •••• 

• ..... • • 

Oantoclllc;TBs-J (EPA FflaSyrnbot t'lSM...£TO) p~ 2 Gf~ .... 

..... • ..... • 

35 

• ••••• • • • • • . ...... . , .. • •••• _ ..... • • 
&EPA United States 

Environmental Protection Agency 

Walihlnglon, DC 20460 

o RegIstration 

o Amendment 

for Pesticide· Section I 

opp ldentffier Number' 

256750 

, : n .. ,.A; Inc./ 

I 

~ -i Inc. ~~~--tti,';;;" ~ . !?' 

DR_ 

• wi 13(C)(') 

In composItion and j 17-17; D, ,ono t:if."" .. , 

Fair Lawn. NJ 07410 EPA Reg, No. ___________ _ 

PLEASE SF.ND AU. CQRRF.SPQNDF.NCE TO lrT. Prod~N.me ________________ _ 

Section -" 

Armmdrmmt - Explaln 'below Fmal prlntad labaItIln ntSpOnn to AgcnC'j letter 4fItW 

fWsubminkm III maponH to Agency lefun dated ___ "Me Tw AwlIl:aticn 

~~~U~~i~~I,,~~\~ •• "'~~'I~~'d~~'II~)'~~~-----------1 

Response To Agency Letter Dated March 9, 2000 and 

Submission of Corrected Product Labels for Registration To Be Reviewed in Place 

of Previously Submitted Labels 

i' 

Sect/on -III 

Section-IV 

, Inc. 

on IfIIs fOfm and aQ attachments lhemtc am tnIft. accurnle and comp1etG. I 

mt$kUldmg atalemWlt may tie PUniShable by fine ()( 1r!'I~rt. 01' bOW 

Agent for lONZA, In<> 

, A McCombie. Lewis & Harrison 03I1712fX1() 

IIRov ..... ) .re 

: 

• 

•••• • • •••• 

• 

•••• • • •••• 

-, 

36 

• 

.. ;-

••••• • • • •••• 
• 

• 

• 

CERTIFICATION OF CHILD-RESISTANT PACKAGING 

PRODUCT NAME: 

EPA REG. NO.: 

REGISTRANT NAME & ADDRESS: 

CERTIFICATION STATEMENT: 

SIGNATURE OF AUTHORIZED 

AGENT: 

NAME OF AUTHORIZED AGENT: 

TITLE OF AUTHORIZED AGENT: 

DATE: 

Dantoehlor TBS-3 

6836-____ (not yet assigned) 

LONZAlnc. 

17-17. Route 208 

Fair Lawn. NJ 07410 

[NOTE: Although Lonzalna. will b. the registrant for 

Dantoehlar TBS-3, it w17l not distribute the product. 

Currenlly Lonza Ina. Is in the process of selecting the 

distributot(s) for Dan/oehlor TBS-3. Once the 

distributor(s) have been selected, Lonza will submff to 

the Agency infonnalion on the type of package that will 

be used far Dan/oehler TBS-3and fts ASTM designation.] 

I certify that the packaging that will be used for this 

product meets the standards 0140 CFR 157.32, 

including the revised standards in 16 CFR §1700.15(b), 

when tested by the revised testing procedures in 60 FR 

37710 (July 21,1995). 

Wendy A. McCombie, Lewis & Harrison, LLC 

Company Agent for LONZA Inc. 

• • • •• •• •• 

.. . ..... 

• •• ..... .. .. .... •• • . ..... 

• • 

•••• •• 

• • .. ... . .... 

• • .. . ... "' 

•••• • • 

•••• 

•••• 

• • •••• 

37 
LONZA Inc. 

CQrporate HeadquanGl'S 

17-17 Route 208 

Fa" La~nr2"i.41~ff' 

Mr. Stephen Johnson, Director 

Registration Division 

ornee of Pesticide Programs 

U.S. Environmental Protection Agcw;y 

Crystal MaU, Building 2 

Arlington, VA 22202 

RE: L(!rtc.r nf Authorizatiun 

e Dear Mr. Johnson: 

This lener authorizes Lewis: & H.arrison. LL.C. of 122 C Street, NW. SUlt~ 740, WllShingron 

D.C. 20001. to acl as UIl agent On beholfofthe following 2 EPA Company numbers: 

• 

Lonz. Inc., 17·17 Roule 208. Fair Lawn, NJ 07410 

and 

n & S Chemicals Division, elo _Lonza Inc. 

17·17 Roule 208, Fair Lawn, NJ 07410 

Company number 6836 

Company number 47371 

for aU regiStration. ma.tters at the U.S. Environmental Protection Agency. 

Iryou hove any questions, feel free to contact me at 1·800·777·1875. exL 2466 . 

Sincerely. 

R~ I )\..0I:ff)V 

Ruth Trugt< 

Manager. Regulatory Services 

• • 

• •• , .... 

• .. . •• • • •• 

. ...... 

• • • • • . ...... 

• • ....... H:: 

• • ••••• 

Te!ophorn)201",7-94·2.tOO • TcItlx 47~ • Fnx ~1-7S4-2S91 

A member M the ArL Alusuiuc-LllhU G:t)UP 

.. 

................. 

•••• 

• • •••• 

38 
• 

• 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MAR - 9 2000 

Wendy A McCombie, Agent for Lo~ Inc. 

Lewis & Harrison 

122 C Street N.W., Suite 740 

Washington, D.C. 20001 

SUBJECT: Dantochlor TBS-3 

EPA File Symbol 6836-ETO 

Dear Ms. McCarn hie: 

OFFICE OF 

PREVENTION, PESTlClOes 

ANO TOXIC SUBSTANces 

The May 16, 1999 application for registration of the subject product is not acceptable for 

the following reasons. The Confidential Statements of Fonnula (CSF) does not agree with the 

label and must be revised so that the ingredient statement matches the CSF. 

Your application can not be processed until the above material is corrected. If you have 

any questions regarding this letter, please contact Tom Luminello of my staff at (703) 308-8075. 

Enclosure 

~~JeJ!n Robert S. Brennis t) "-- Product~anager(32) 

Regulatory Management Branch n 

Antimicrobial Division (75 I O-C) 

39 
, -

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D,C. 20460 

Wendy A McCombie, Agent for Lonza, Inc. 

Lewis & Harrison 

122 C StreetN.W., Suite 740 

Washington, D.C. 20001 

OFACE OF 

PREVENTION. PE"5nCIDES 

AND TOXIC SUSSTANCES 

SUBJECT: !'llmWOromIBS-3 })fiN fa ch lolL I B S '- 3 

EPA File Symbol 6836-ETO 

Dear Ms. McCombie: 

The May 16, 1999 application for registration of the subject product is not acceptable for 

the following reasons. The Confidential Statements ofFonnula (CSF) does not agree with the 

label and must be revised so that the ingredient statement matches the CSF. 

Your application can not be processed until the above material is corrected. lfyou have 

any questions regarding this letter, please contact Tom Luminello afmy staffat (703) 308~8075. 

Enclosure 

Sincerely yours, 

~~ Robert S. Brennis 

Product Manager (32) 

Regulatory Management Branch D 

Antimicrobial Division (7510-C) 

40 

• 

• 
Q 

<: 

z 

g 

u -

3 

'" 

....... • • •• .... '" 

• • ...... 

• • .... "' .. •• 

• 

• ., . • 

• 

•• 

• ., 

•• . · ., •• • •• • • 

• 

•• 

• •• •• • ..... 

· .. •• • •••• 

• 
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: 

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SUBJECT: PRODUCT CHEMISTRY REVIEW - Antimicrobials Division 

DP Barcode D262240 Reg. No. or File Symbol: 6836-ETO 

Manufacturing-Use [ ] or End-Use Product [X] Ca."e # 

TO: Robert Brennisl1llomas Luminello 

PM T earn No. II 

FROM: 

THRU: 

THRU: 

Anna Skapars, Chemist 

Chemistry-Toxicology Team (CIT) 

Product Science Brancb (PSB) 

Karen Hicks, Team Leader 

ChemistryfToxicology Team (CIT) 

Product Science Branch (PSB) 

Michele E. Wingfield, Branch Chief 

Product Science Branch (PSB) 

SUMMARY OF INFORMATION REVIEWED AND FINDINGS 

BACKGROUND: 

This application is for registration of a new substantially similar product. 

FINDINGS: 

The Confidential Statement of Formula dated 12117/99 does not agree with the proposed 

label. The CSF is not acceptable . 

According to the Confidential Statement of Formula dated 12117/99, the label claim 

should be: 

1, 3-dichloro-5,5-dimethylhydantoin ....... ~ 

1, 3-dichloro-5-ethyl-5-metbylhydantoin ...... 8.45% 

Please note that source product for the active ingredient is: 

I, 3-dichloro-5-dimethylhydantoin ....... , . , . 86.0% 

1, 3-dichloro-5-ethyl-5-methylhydantoin ....... 13.0% 

Therefore. 65.0% x 0.86 = 55.9% 

65.0% x 0.13::= 8.45% 

Please submit a corrected CSF and label so that the label claim in the label will agree 

with the CSF. Provided the product chemistry data in MRlD No. 450008-01 for 

43 

----------- ---~-... 
.. 

j,.. 

~ 

110--

~ , 

,. 

II. 

Guideline Series 6J, 62 and data matrix for Series 63 are in compliance with 40 erR. 

Part i 58, 155 through 158,190 Bud these data satisfy product chemistry data for this 

product. 

Submit corrected csr and label and revise the certified limits in the data package. 

including corrected certified limits. 

44 
, . ; 

SUBJECT: PRODUCT CHEMISTRY REVIEW· Anlimicrobials Division 

-pp-#""!codt D;Z/?2;ufO _R(.ik~o.-Or.f.nldi?,"ffibui (p fS3&~ ETO 

~mufaCTUring.Use l ) or End·Usc: Product I vi Caseil __ 

TO: _ Rdls!t Sl!/iWn,! Tf<puILJ .to,,~ r,,1to 

),M Team No . ..-"3!<e,jLFROM: 

THRU, 

• 

Ann' Sk.p .... Ch,mi~ {irwL S*"faM OJ2. -17-,;J.q"~ 

Chemistr)'-TOl<icoiogy Team (CTI) 

Effic.cyand Science Suppon BlOnch (ESSB) 

Karen P. Hicks, CT Team Leader 

Efficacy and Science' Support Branch 

Antimicrobials Division (7510C) 

THRU: Michele E. Wingfield. Branch Chief 

Efficacy and Science Support Branch 

Antimicrobials Division (7510C) 

T"'"1 C<fF'C«>--L<rl1- /s ft7G v.:J$jha~o,(. cl ;lffi' suta7Q;f,"'t~ .$<.J>"'~<"" 

f'.",:ck er. 

---_ 5'5 ·0/0 Yo .. 

_f'{:!t:f% 

. . 

-l--~/~u . .(,.ia({Z rS 

45 
• 

• 

5~J1rr"t~l:: C:\!uU r;;e--

£w,u'l,<, .VlC cat: 

46 

... , .. -"",,'~.------------
.. __ ._----

-OSE ROODe KA~U ~CTU I -USE RO U 

EPA :Reg. No. (or File Symbol No.) " 

Registration Iv] 

D;?'t, X;J.I{o 

OP Barcode/Chemist: 11,,"6. S""'f.<VlJ v.9./11/:JP!?O 

1) 3) 

2) 

1-

') 

Product lIame: ]) ao'li1.""lflt7L. I i35- i!! 

Reregistration I 1 

Case No.: 

• 2. company: LOll;} CL / -:r;, c... . 

Type of, Submission; New [\>/f Resubrnission [ J Amendment [ 1 

REPACK [ ) 

• 

3. 

"ME-TOO· ( 1 1.1 ternate Formulation ( 1 

Expt Us .. permit (J Other (SpecifyJ ______________________ __ 

•• CONFIDENTIl\L STATEMENT or fORMULA 

4a. Type of formulation and source registration 

• Non-integrated formulation system 

• yes [vf • no 

[v] 

I J . Are all TGAls -used registered 

Integrated formulation system 

• If "ME-TOO", speci fy EPA :Reg. No. of existing 

product: 

t J 

4b. clearance of inerts for non-food or food use: 

.c. 

.d. 

Cleared for food use under 40CFR§180.1001: 

• y ... [ 1 ' no ( J. If yes: • c( J • d( 1 • e [ 1 

Cleared for non-food use! . yes [v1 • no ( 1 

Physical state of product: 'TaW 

The chemical lOs, analytical information (including 

that for the TGArs)! density, pH, and flammability are 

consistent with that given in GRN 61/ 6./ an~ 63-7/ 

63-12 J and 63-15 f respectively.. "yes tv') • no ( J 
• 

3 

4e. D<>nsity (or bulk density ror .oUds); at 

4f. pH (if dissol':~d or dispersed in water); ?·:i.tf 

4'1. nash point and/or flame extension: !'lIlt 

4h. NC" and CLs are acceptabl,,': • [.rl • not acceptable ( 1 

41. Active ingredient(s) NC_ LCL DCL 

A. J (J ,.~. I 3~ d,;·cJL[.i5UJ-0,S:.dH"':zJ(.YL!.V;' d<;,;L'M- Sif.'fIJ 

B. ~g- t:b_'{;.M~,"' -5'. r:tl7l"-",--nlt . .llilJdk .. ,

C . 

D. 

4j. For products produced by an integrated formulation 

sy!Stem: 

• 

All impurities of toxicological significance have 

an DCL: • yes [1 • no [1 • not applicable tv1 

All impurities ~ O.lt 

identified:· yes ( 1 

in the product have been 

• no (1 • not applicable 1,1\ 

5 • l'ROPOCT LlI'J:L 

• 

Sa. The active ingredients $tat~ment (ChemiCa~ IDs and 

NCs) is consistent with the CSP: • yes (1 • no ( J 

5b. The formulation conta·ins one of the following: 

• 10% or mora of a petroleum 

distillate: • yes [ 1 • no [y') 

1t or more of methyl alcohol: • yes [ J • no [/l 

• 

• a 

sodium 

toxic 

nitrite 

List 1 

at 

inert 

any 

at 

level: 

any level:-

• yes 

yes 

[ 1 • no [~ [ 1 no l:;l • arsenic in any form: • yes ( 1 • no [, 1 

Sc. If yes to 

statement 

• yes [ 1 

any of the above, does the inert ingredients contains a footnota indicatin9 this?, 

• no r 1 • not applicable (,/) 

5d. The appropriate warning statement regarding flammability or explosive Characteristics of the 

product are given on the label: 

• yes [Vl • no 1 1 • not applicable [J 

48 
• 

• 

Se~ The storage and disposal instructions for the pesticide 

and container are in compliance with PR Notice 84-1 for 

household use productp or PF N~tice 83-3 for all other 

uses: • yes [/ J • no [ J 

6f. Does the product require an expiration date at which 

time the NC falls below the teL (based on the one year 

storage stability data or other informatio+Q: 

• yes [ J • no {vJ 

G. PRQPOCT CHEMISTRY (GBN fl, G?, '3) 

6a. 

Limits' 

62-3 Anal Method for AIs7 

49 
• 

FRONT END PROCESSING APPLICATION INFORMATION CHECK 

PM 3JEPABEGlSTR.AnON NllMBl!R 

STATUS (For Am ... dmeats) 

UM .. Too~ CITED PRODUCT STATUS 

Aclive, __ _ C.n •• Ued'--__ 

Not in REl!S ___ _ 

Active '-- Con • .ued, __ _ 

NOliD REl!S ___ _ 

50 
oEPA 

,,. 

Utlll*4 Sil.l.tu 

Environmental Protection Agency 

WBVNt'OtQn. DC %0400 

, for 

§ Registration 

Amendment 

Other 

i I 

1. Coml:umyiPtoduct Numbor ctau/fk:ation 

r-----~----~----------------------------_+_C----------------------1 ... CompAny/PfMuct (NIlI'M) PM, DN.M D~rn,~ 

o y.,' 

0"' 

I to", 

CertificatiOtl 

a. Expedited Review. In acCt'ltd.nce With AFRA $action 3(clt31 

Ibltll, my pmduet 1$ 3lmilifr or identical in eomp03ltHln und fabl!t!lno 

to: 

EPA Reg. No. _____________ _ 

h. [Name 

- II 

o FintiI -,mnfAd IAbolA In 'GapMon. -to 

..;;;;.. AUOfllWWUtrdatad __________ _ 

"f.A,t Tf)6'" Ap~¢A1ll)n. 

= Ollar- Exphdn WIIow. 

U (Hhltf 

, -IV 

G. Out() Application 

I tanffy that 1M a,lrtamentll havo mlldo on this ham and aU itttat:hnlUllts liulloto aro ttuo;. llCetlfMO ornJ oompi.to. fto:Kl~ •••••• 

both I thl:':~~7w1nglV I.hio orml.hnu:ting-Iltatcment mtJ't' be punblkGWo by Jinu 4t inIPtht(mn'ltlrtt or 

, !3.n" 

.. ,,,..",,,,, 5.0attl 

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• •• 

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• • •••• 

• 

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• • ·"to •• 
, 

, 

""Iiti. fum hi: ro ..... WUId fl;!t lUI .-ppl1::4tJeM 

In M(ll}f 

fU 

t'1-Pf~M'~~ 

ftbVl f.,~' lUI4,ul!!i 

{(If 

WI!g1lltrllliM. 

.new ft1giw#tio« 

~. 

~«mtW1_ 

r.lh~'14 

th1,,~wrn, 

~ 

tiI'J -

1':;);!;Ill:!!!ll" 1hfw "<rtI(t1l 'fi'J1Jit btl twrni!tltouf., H ~utWt, r.ft Mt feputtWh mrt:\$fW, 

t, Ctmlpan-ylPtiHfuct ~ ~--bwutt_'f1lUf Oxnpen'f Numh>lt. If tmJJl tun ~--"l!Iwio~n~y eA. ihI. ~-m&V haw. mn amiMd- to 'iN'" U$" 

ba.: ttli,tll!lttmtt. • "dIoftlbuW;"m' iN lin tHlmmltim~jL_ -w Y<JW IJlcQ;.uifU.' t.!i~.-~;~ ~t ~< 

2. EPA ~ M~pt'~-Jf ~j mll~1h.-f!l#lm MtliPM numbrw"'-'it$--~A'~l¢tM~, 

" Pf.~ ClI4IMk&Uo#l' w_s~ lhit Pf(lp~ al.umHktttiiM Qt. i~ ~ ";'. 

t.; Prolfua.N.m.<·Enttf the ~bjpfoouet tUwn4lJf tNll pHllcld'-illlIlt-wHf~ (Hi Ott ltibol. TIw; MmIlmtat bnpKHhfto IhllI ptOOuci M'Ay. 

O!Jptlaauon frl nan'ImI t. rnH permltied ImIOmi JH"~ty Qt ~ ~~, ~)IOt~ anv fMlMd mm\'II' m' ~1fiW1M_d~ 

.K UIJITI1f '6rt4 Ad ....... ~ Tla rmnw-ttfUM firm (It i*'Mni and~" ~Wtl-~ 'fWr gp¢lmlikH't m'th? ~ of firm to w~ tm 

!4!plttfMj¢ln" wilfbii ~ 1t,Y'W m'$ ~1li1-1n t!®liI.' '1f'wwti:Mif"PM"ttt·"you Mt~ ~tetMn ft~ th4t ~~-to HI 1m: tkmtdn t~b1IJk>rt 

fmiU;;W, Aft ~ ffqt 1~ 10 Wf urntlid SfBllJ'$ fft!.Wt hWM".!JA ~m ~ ~ in thl united SMn W #t1 f9t tfmrt In !I!i 

;!ffl!litrildiP(mottutiii: ~ iWtf!e w~.,. "~~--9( :Wd;_lm-~roiJn ~ iJUJ ~0f4 

9, ~ ~ ,.'FIfflA ~'1 te}t·{s)~" jot.~ MiiiW,\if~~fwJtJt I~IM\ ~ ~1a ~_~-f~iJilitrtI, thb\ W"1J ~1It-:¢t;~ tQ_~~t! VlodiJlAA ltHrt it.,-Wft~¢y-i~ M_W -'tfi.c"E?A. in oftW fOt''Y..wt--~!trW ~JUt 

1jnlll'dilod-;~l!w~-¥iMf~t~o w-wi!h th+ £PA a~(t!ttWll NjJ~AJI\I.rt!i~f-imtM -oi tho product ~ ~Jt~-~ i1im#iff-w Ilf_,-- __ 0: 

YOU!' Il.UiWtlt.:_1M ,,~t f'flU4tW ~Iif ijf~#lS44t In ba-th t4m-m1MiMt. ard I<W~ U#Mf . -

--', - . 

t~~ ~ MJ'I~ 

I, Subp.". of '".~t"- e:iM~ frw ~pnbltf LWeI.. w&ilM"vld4 liw-A(t41WY ~_lj!_4~tb--if JlWtopn_i)lO, Pl:~vfJe jJ brict.!!JliJlMW>t\ iii tl' .. 1xHpM«fiJ 

fO( In. wbmnaipn, ~¢h .. ~tha ndditiM of ,. Mt&, ~ ot ~QP _~·:r~ 1~ ~MI_UtlJtMMnAnt -¢-~ bV, ..... ; ""t~tA~ 

l~~~ "Ql!ntfil Istutl t~ -M 11" ~iftmR.· AtUtiifu ~~P~Jfi~ JP~~-mlltdild. ,- -- - -- -- -"> • -- •• ";'> -. - • -, -. 

llrut CC.ntaUiM Inf;irrNuHlI'tl Thill S-4!(:liiri~k~.~iJ~ '?i~_ ~~~ ~$d fit o/mM$rtM vmf%"Mw 
& EPA 

LOmA,lnc, 

17-17, Routo 208 

FaIr lawn, NJ 07410 

Untied States 

environmental PtoIecIion Agency 

W8$hinglon, DC 2G460 

!81 Regilltralion 

o Amendment 

Application for Pesticide - Socticn I 

181- 0- , Inaccordance 

(b)(lJ. my ptOduct is similar or ldentlcalln ccmpo$ition and 18b<.1i~ to: EPA Reg. No. __________ _ 

P'oduClN8""' ___________ _ 

Socllon -II 

AmttndmUt1l: - Explain balow. RrtaI printed labala in responH to Agency letter doted _ 

RetubmlBiorc Too" AppfIcation In ItnpOnG«tto ~ Itttetdated' ___ _ 

Socllon -iii 

Y .. 

5Ogram'l 

_on-IV 

AQent for LONZA, Inc. 

'Vi,endlvA. McCombie. Lewis & Hamson 12/171iJ9 

• 

• •• •• • ..... 

• •• •• • •••• 

53 
. "'"". 

&EPA United Statu 

Environmental Protection Agency 

Wuhington. DC 20460 

r- Registration 

r- Amendment 

'- Other 

1. CompanylProduot Number 

5, Name Bod AddreSl of Applloant (Include ZIP Cede} 

D 

"-

~ Rlliubmi,alon in response 10 AgnrICY I datod 

o Am'''''~''' -,,,,,I., "'ow. ':::;",(";~t 

~ NQuficlitiori' Explmln below. 

Explanation: 

Chlfd·Rasl$tant Packaging 

By,,' 

No 

"," 

Unit Packaging 

- y" 

- No 

II ~yo,~ 

~Hcation must 

,.,bmlttmJ 

Unit Packaging wgt. 

. ,." I 0 Loblll D Contmner 

6. MOrlner in Whioh Llilbol h. Affl);6d to Product 

/ 

/ 

No. per 

conWinor 

, for 

11d. 

I I 

2. EPA Product ManGoe, 

PM. 

3. Proposod Cf."ifiClltion 

D NOM D R.5tri~t8d 

6. Expedited Review. In accordance with FIFRA Section3(c)(3) 

{bUll. my product Is similar or Identical In composition at;'ld'13beiing 

to: // 

EPA Reg. No. J 

Product Name / - II / 

o Final printed llibeis In tO$pOfllllll'" /' 

O AjitlMY lottor dllted .7"/-'------------

"Mo Too· Appllcatinn. >' o Ollul, - Explcl.n bot6W. ,/ ,/ 

I -..!.!!. / " / 2. Type of ContniM! 

~:!~c Gloss 

Pap.r 

Oth.r's', •• If~ ______________ 1 

-IV \ 

,bOo , t .. "'''''s/h~ 

\ No. (Include Auo Codal 

Certification \ 

I comfy that tho stalomants I hBve mad. on this form and all sttachments mereta ere We, accurate and ".''''''\''' 

I HCknowlttdoa that any knowingly (also or misleadino statement mllY be puni.tKIble by fine or impriwnmont or \ 

both undO! epplicabl.law. 

6. Oete Applic/l1ion 

RI)ceivod 

(Stamped) 

2. Signetur. 3. Titl. 

4.TypedName 

"'A Fonn "70.' ,""Y.' Copy 
--- ----

PAPERWORK REDUCTION ACT NonCE and INSTRUCTIONS 

I ,~::~:~=~nu. form ,e to be u#od for ell aplillcotioJlII for mlW rcgbwUon,. -end use tetag/ltuation. amendment, ruubmInion. to *f)piklBtlOM I for I • tlnaI i labeling. farag/;Inltion, IlIC. In Oldar to process an application fO( a new I'lIgirrtration submitt6d on this fonn. the- .-- ~ony tho tlpplicatlon: 

1. Cartlfk:etion with Respect to Cillrtion of Data tEPA Form 4S1()'29). IIf not OXOfflptod by 40 CFR 152.81 Ib} {411i 

2. ConfIdential $hltoment .of F<>rmu!. (EPA fotm 857004); 

~, fi)rmt!1atoi'll ExompUon Statoment !EPA Form SS1Q..:2.71; 

4. Av. eopitIa of draft IlIlafIno. 

5. TIlt_o eopka ot anv data submitted: 

6. AuthoriUliion foUer whofo dppliellble: 

1. MIIttion w~ Bpplicnbf". 

I ......... 'M of Lab.UnO· Labeling Oihoutd first bit IIObrnittw in 1he fotm of draft ItIblJIa with ell (li:)pllcatiorlS fot MW rtlgistnttlon. Su"h ",.fI''''''"m.y '.1 II" the f~.~i typed lab'" text on 8.5 x 11 illCh peper for suhmiwon or a mockup ofthft propoud Jebel. If prGplted for-mockup.lt.~~td be 

1"'Mtru."d I. I waV all to raclliUltv slOtage In an 8.S x 11 inoh me. Mockup lcbtls significantly *IDllllff lhen 8.5 x 11 Inchu should be mountsd,cn 8.5 Ix '.' IMh ... " ,O! ........... . of Oeta • DIl!a submltted in .upport o( th!, tJPI)lication must bit submitted In &coomance with PR NoliC1l as-s. _ 

PI.as. rtMd thelnstfUetiorl$ U$toW b~(lw bflfQro com¢aliflG tMs spplic4tlon. First @to'rmino "::~;,,::t:::~~~"~~~ '~I~:'..!'llted 1; in ~ ~"~:: ~ arOll submittinG this ""pllc.tlun. For ~ons wbmiu.d in oonMctiun with New RagiaUation BIllions, 

-":::, ~ IV n '.~Y ~he tor ""plicalions submitted In cOOMCllon with amended I"$regilatttrtion 8CtiOI'l$, reoobmlnlorur, 

i I, n, muJ IV mwn be oomplet4d bf th4 aPpllednl, 

BIllion for which Y«llUe submitting this form. 

12!;l;mQlI.II!- This slN;tion must be oomplotod, &lJ i¢lpllocblQ, fot.U r.gisUalion eCitiontl. 

1. CompenyJPf(lIwct Number-Insert your Company Number, If OM hubllon eulgnod by EPA. This numbwmay Imw bun •• ~ to you e. a 

basic registrant, iii distributor, CJr as an o$teblishment. If your product I. r&gllttered, insart the Product Number, 

2. EPA f>rodu<:t Menqw- ff known, flU in Ihe fU'II'I'lII and PM numbef of the EPA Pmduct Mol:\OflOr. 

3. Prop_d ct ... lffq«tlcm ,. Specify thlt propoted elusificlltlon -of Ihls prodWt. , 

4. Ptod~ .Name - Enter .tM eomple.ta product name of thi, p4lltlcidc as It witt sp~ on tho Wbol. Tho MmO muat btl s.p&clfl~ to thl~ pr~ul!t on/V. 

Oupht4lUon of netTKltI f$ not penrnttlld lJITlong prodtie:a I>f tho ~_ company • .Do not lmludo any brand rwma or 4ompa'tly tina dClbgmlfiO/)d. 

5. Nam. and Addr_ of Applic«nt- The Mm6 of the IIrm Of pllr.orraMl, add",II' choWn In your epplication ls tho p&rnm Of" finn \0 whom tfw. 

IltgJttJaUcn wUL be. rtau:ed. If you ero Mung In beklilf,Qf anathur party, WU must sUbmlt authorization from that party to ItCt forthorn In tOJJllltrumm 

mllttllnf. An appliqant not rhiding In th$ UnltoN-Stat#S must hftVO ml authotlm ~nt rHklino In the United Statu to am fot them In aft 

r.gilluatlon mllllOflt. 'ThIll. ~ end complete maltfng. &ddress of $ut'h &It apt must acoompen,,' this eppIfC4l1Oft.. 

6. Expadtte'd ftoviow· flFRA. S!Xrtlon -3 (t') 3 ISJ proVia" tor l»piKIited r1Ml;lw'Ot;~wtIl)ns fot r.oi!ltration. IJr -..nendmtnts- to e!ds-llng rtolatulliol'l$. 

that M!" $Imilar- or idantlO3l to other pastickfa produO)t4,thot $Ill ourrontly ~~ wM thfl EPA. In ardor fot your lJ1PII~cn '~:~ ,~:::~~ 

o)(pedlfed rcvUlW, you must provide us with tha EPA'!'!!lQhltnrtion Number imd prOduct nsrM -of tho product -yqiJ bell'eve I, mmtlar to 

yout product: TM product must !a sirnlhH or identical in both fOtn\Olation and MbtIed U$O'. 

:~~~~I¥ n.Si'hi1 •• otion tnllllt bo completed fot eI1 ""plication • .ubmiued to \\Mana tho rogiflratlon oNy.of a eumll'ltty rtlglstoJ'04 ptodu.ct a lallllbmisuion In roeponH 10 an Agency kUor, fol'" notifio.tions to- the,AU"I'Wf. for tho milimiMlQn ·of finef pfintlMl IfIb4fing, for 

for an'( «hi» aelion thet pertmM: ta e 'WHlfh; gPA'fOgistfltW j)rru,lul!t. Thil netlon i.-!m1i2.!a Uled f'Of. MW application for 

1. Subjee( of e-ulttniGlion - ChltCk tho applicable blo(;k, llO4 plowoe the Agoney lottor dllt.1f appropliate. Pmvlda II briaf oxpf.anetion of tho putpMdl.) 

fot 1M .!lubmilll,ion, weh as ~the &dIfrtion (If /I sitlt, pu.t or crop tspeclfy)~f "tIfl14(1d tho CCnrldontIai Statlm'lMlt of Formule: by ..... ;. ·reregistration 

,ubtniulon": "'ueneral Wbtf tell1sion of 1,1'0 d!rectiohlJ." Atueh 11 stpl1lalo page If oddltionst $poee n OIloded. 

I~~~~"~n 'IPeek_ging and COntaiMr In1otmlllionJ • This Sectfon mutt be c.ompl(!ted h/f all appliclitloJl$ wbmittcd In conMlltion with n!lw II or appti1l:lIhkt IIfI'HIndmonts. 

1. Type of PackagInG· Chock the 1lpp1'ltpriato block It yoUt product wlll be poc-klllJed in tho indictJtmJ peekswnD types. 

IndletJte tho SIZe! of tho Il'Jdlvldual packots and tlUmb"r par retell eontaiMt. 

2. TyPll of Ret$ll c.mtlrioar -Indicate type of eontalnl!lr In Which product will be mmkotod. 

3. Locatfon M t.k1 cCntGntli ·Indlcnls tho Ioeetion of tho net contunts information fot your product. 

~. Sl%o".) ~ RotalrContainu- SpiiClfy tta mit co.nttnts 01 all ratllfl oonteftlOfS fof '«<Ir p(lUfuct. 

I~. l~tlon of u.a DUactioM.- fndlcat8 lh.lol!ation of tM use diroctil)Nl for your produOt. Is. ManMr in which labol k affill*d to product· IndiClrted tho method prodUot (abel fa- att&chad 10 retail eontaiMr. 

IIV Thia Section must bo oomplatod for 1111 appficl!ltlons (or Reg/stration actioN, I.a .. MW products- rogill'Uetion. 

"me-too, ~ reregislration, atc. 

!,5. Sejf ... xplandtory. 

... EPA UIO OniV. 
- ---

...... L 

. / 

VnlttM1 SlDtu Registration "",""" oEPA environmental Protection Agency I- Amendment 

W.llhinglo/'l, DC 2.0450 I- ~l5l'oa-O- Other 

I for I- I 

3. Pt~ Chwilbtiol'l 

~----------------------------------~~--------__ L--------4 ONOM 00 ... «0 I", C;,!mpllf!V~oouuf IH~) PMt 

" ... 

• WIn .. 

F Yn 

~ N. 

I 0 loom 0 CuntMftf 

N""", 

I nrtHv Utel 1~~~~VtMWftt., J 

11no~~, :1.:: 

1. Slgnatu,.-

•• Expedltod nov"'w, '" >e<:o<dil1lCO with FlFIIA Section 3!cIJ3) I:;ui'my ptOOUCt is slmlli!Sf Of kfOOttCal in ooroPOSII.lo1~,UJ~ Ia.~ 

EPA R.g. No. _________ ~ ____ _ 

,N.ma 

I' 11 

S<\ction • III 

,·IV \ 

111'" 

3. TiU'I 

. 
~-~~-~ ~ -~------------

PAPERWORK REDUCTION ACT NOTICE and INSTRUCTIONS 

PAPERWORK REoUCTION ACT NonCE; Publio ropordno burden for W. collection of infotmtltion fa .. t1rnatod 10 ~ 0.115 hour JHH" 

tUpOnd. tnckIdIng'tfrntl for I'1Iviowlno Iri8'flUeUol'Irf. lHIMChlnO .mstin9~~ ~rc.,ri gathtrlng and malntainlno'tbe data nHdtd. and ocmpIetlng,and 

,.viewfug tha ooifectlon of information. Sand oommont. rogordlng tM, butdlU1.~"fn'lIrt~))f any ethv ,lNpeot of thItI CQ/I/l:otion of Infon:ns,Gon, Including. 

wQOefltiGM fflf -reduoing thi_ burden, 10 Chibf, Infom'\ation Policy Branch. 1,2138), U.s. Environment$! Prot.cUen A~nev. 401 M Stroot. SW. 

W .. hinglon, DC 20460. ' 

~~1t.l!5~~~ 'This form If!: to b" ullod for.u 4pJJIleadons 'or new registration. end un reregistration, amendmon~ resubminion, to epp!foatlo". 

prinUid labeling. reregistr4tion. etc. In ordor 10 ptOCU$ an application for a new registration submitted on thla form. tho 

loaowfng moat 4M:compaAv the appIketiQn: 

1. Coriiff04ltiOll .;drh' ~oat to Cltbtlon of Dote (EPA Form 8570.29). IIf not .xotmplod by 40 em 152.81 Ib) 1411; 

2. -Confldo1ttisJ S~ of Fo.rtnt.d. (EPA Fonn 857<KI: 

3, Fonmdatot'. Exomptfon Statement (EPA Form S57().271; 

4. Five oopiH 0' droft JaheIIog; 

5. Throe co¢u 01 any data submined; 

6. Authortltltion fen« whitt" 1I9P1k1lbl.; 

7. MIrtricD~~ablo. 

;~~~1:;~~f.~~~:':houId 8.5)C 11 fiHlt Inch b. paper wbmlued ror tfUbmiS$foo In the 10nn Qr of III draft mockup latUH: of tho with pt(lpOsod 01' appIicatiOM' 1~. !f If ';'.:', ;"';w~r;~~~~~~~~;~k,::~ 1M m'~ '~'I faclUtate storage In an 8.S-x 11 Inch flilt. Mt>Cktrp label. signlflcant"i smallarthan mounted on a.s 

subrniHlof1. 

In support of thlll opplicotion muM be $tlbmittod In lK'Cofdanoe with PR Nolio. 8&.5, 

I ~~:.I~~~~~t1~~:.PleGGe re8d tho irnltlUctionll listed below befor. "GOf'I'iPletlng tN. opplication. Firet d.tetMlrnr "::~~:.~t:::':~~;:1 I; you tiro submitting thiJl.upplleatJon. FQ( application" WbtnItted In CCMc<:tion with New RegisttaUon 

IV mull be oompleted bVthG applicant. For IJpplioDlions submitted In oom,.ction with amended reregistration ectllUW. toSubmlu5iQru:, 

1~>lIfl'~li'~~~. tarogistrot!oM, .oto" SbetioM I. II, end IV mu.' b" oomplotod by tho 3pplicant. 

A· Cheek th. appropriato ootion for which yOlJ ate submitting this 'orm. 

ISJOkmlli.l. ThhI: lIotcl1on must b. compl.ted, 6S applic$lo, 'or;aU nlalatratloll action ... 

CompanyiProdtJc1: Number' IMe~ your Company Number, if one ~. been Ilulgned by EPA. This numb.r may tuwe boen MsigMli to 'y01J "" I): 

baeit.:- registlanl, a distributor, or as ill e.tobll.hmont. If your ptodU01!, ,.gl,t.rod, IflHIt tta Produot Numb.r. 

EPA Product Manager· If known, till in tho nlm'll! and PM numbcrof tho EPA Product Mon.r. 

Propoelfd ct...IffCllti"on· Speelly the propOlled ellsaUioation of this product. 

Pfo{tltCt Name ~ Enter tho oompIflto product Mml) of thIs pellUcid • .,. It will OPPMl' on tho lobet Thll namo- tnUot be .~mo to,thiIS prodUot onlY'. 

OUJlUoation of /WMS i. not pa«nittcd GmOng produ(lt$ 01 tho sQt1l4llO!'11p&(ly. Oo,Mt lnctudo any bUM nmno Of OQITIPJIn~ liM iUI$lptIono. 

5. NllfI\. IIt\d Ad .... of ~. Th. nemo flf tho firm urpar40n-,md oddl" c:how" ill- your epplltl4\fon lath. ~rson.or firm to whom tho 

rllQinration wiU bel illlMl'd. If you 1m! MtlftO in b&hllif of anothet partV.,)'OIJ mtnIt lIIJimlit IItIlhoriUitltm from 1hst patty to otrt for th!im In ~gi8t,ation 

mattu •• An ;epptlOImt not roWin" In tM Unit/ld Stat .. lTItJat hav. WI-authorized agent u1aldlng In tM United SurtOlJ_tQ-act fO!' them tn- all 

reglstrstlon motton-. Tho name tnd compkltG moIlfng a-ddr.s. of Net! fill aQant ITWst oceornpan',<' thia appIloa;oo, ~ 

6. ElIPlfdha4 Rnklw· FIFRA Hellon 3 Ie) 3 (8) pr4VidIJit fdt a-lIp&dlUtd t6\i'W-;~t'~f!t for ~tforr.- or IImOI'/dmotlt$10 exiJtlng- ft'Qi$fi«dQrul. 

that AI. MmIIM or jd_~ t$ otl'!!Jt fUl$tioide- proouetf; thfttiWl OOfr~I!Y ~~ed with ,tM EPA. m ordlu for VOW- sppfIca:Uon-to be,~ roA 

Ilxpedit64 teviliW, YOU-lTIUst prnv«fe Ult With Ul6 EPA Regi$lnltion Numbof' and ptOduot narn. of tho product you belHova 1. IIimiIot to Of'-~c'" 

your product. Tho pNXfuct mu.t be llimilar or idantlcalln boUt fomwlatJon and Iahe!/Id uus. 

1~£.t[[!Q]!l,ll· ThItt coctlon must be IWITIplob$d fOf ell upplleotions oubmltt,", to ~ 1M rogistrlulon only of .. el.ll'lllf'lttv rogillwad p«Iduat 

IAmendmentl, for a flJlubmhuuon In ntlpOOlle to em AgOnt<y leuISr, 'or rwttfle«tlont to tho A(illncy. for tho tlUbmiHion 0' fll'IDI Printod labelinQ/fIW 

rorogiRtrfliion end for MY otMr dCtlon lhat p.ftairUI' to a Ws!f1o E'Pt"!'!iWi!lliftd prndu'1t~ Thli'uctJon I. nal!2W! 1.1_ fOf II ""w i!ppII(letlonJor 

r6Ui5trntfon. 

1. SubJ-ot of .ubmfulon _ Check tho appIroable block and provide the AOII_V lotfIK date II appropriale. Provide a brio! explAAatlOl'l ot tho ptlqlt'll!$M 

for th$ submission. !IlJah .. ~thO addition of a site. pest or crop -tspe(:ify)·r~~ thIS Confidontlal StlltolTl8nt 0' Formula by ... ·; ·reragistrlltioo 

IIUblfljsllioll·:' ·~nofalloo", rllvi5l'0n of 0118 dirllcliona." Attat:!l JI aoparatc pUC-it tf i)Ii';fd!\Io_1lllt $pOCO' Is needed, 

IPaclt&v/og and Contuinllr In'ormlttiunl • ThIs Section mUlt b. eomplstod for all epplicationG submitted In cOMllction with new 

block II your prcduet will bo poekbgod In the Indicated plWkoging typo;ll. 

i the- $l.tit thO numbor por rota» contolnof. 

2. Tvpa of RotaIJ CootlJlnH -lndlclJto typo of conUllnur In whloh pfoduot will b. narketod. 

3. Loelltion o(N*i C<m«lnta· IndlriW tho'klcatlon of thO hOt cantOf1ts iflfomtatioll fot vour)iroduct. 

4. Sl.zel.I of RIItail Con~. $ptloffy the Mt Mntent. of 1111 retail containers 'fir your product. 

5. loeetfoo of u.. DlrectJOM' Indleattl the locotlon of the vae directions for ~f product. 

6. Manf}flf in which lalalia affixed to prodUct. Indlcatod 'the -methOd prOduC1 iib'ens .nltched to ntsil container. 

1~::':E~!!.~;,;c~~:; ... ::t Pointl • This Soot Ion mutt bo completed for !III epplieatiof\ll for Reglstrellon eatlonlt, I. •.• new products regiettetion. II rucgi.ue(jon, eto. 

1-5, Sol,·explanatory, 

S. EPA. U •• Only. 

------------------.~.~ ... -~.-
• 

• 

, , 

CERTIFICATION OF CHILD-RESISTANT PACKAGING 

PRODUCT NAME: 

EPA REG. NO.: 

REGISTRANT NAME & ADDRESS: 

CERTIFICATION STATEMENT: 

SIGNATURE OF AUTHORIZED 

AGENT: 

NAME OF AUTHORIZED AGENT: 

TITLE OF AUTHORIZED AGENT: 

DATE: 

Dantochlor TBS-3 ' 

6836- ETc) 

LONZAlnc, 

17-17, Route 208 

Fair Lawn, NJ 07410 

(not yet assigned) 

[NOTE: Although Lanza Inc. will be the registrant for 

Dantoehler 18S-3, it will not distribute the product. 

Currently Lonza Inc. is in the process of selecting the 

distributor(s) for Dantoehlor TB8-3. Once the 

distributor(s) have been selected, Lonza will submit to 

the Agency inlonnation on the type of package that will 

be used for Dantochior TBS-3and fts ASTM designa/ion.] 

I certify that the packaging that will be used for this 

product meets the standards of 40 CFR 157.32, 

including the revised standards in 16 CFR §1700.15(b), 

when tested by the revised testing procedures in 60 FR 

37710 (July 21,1995). 

Wendy A. McCombie. Lewis & Harrison, LLC 

Company Agent tor LONZA Inc. 

•••••• 

• •• • • 

•••••• 

• • 

.... • • ... · •• • •• • • •• 

• 

•• • •• • 

• •• 

•• ••• "'.... •• • .. .. ..... • • .. • •• •• • •••• 

· ., •• • 

•••• 

58 
• 

LONZA Inc. 

Corporate Headquarters 

17w 17 Aoute 208 

Fair la'1'l} NJ 0]410-2.621 

May 27. 1997 

Mr. Stephen Johnson, Director 

Registration Division 

Office of Pesticide Programs 

U.S. Environmental Protection Agency 

Crystal Mall. Building 2 

Arlington. V A 22202 

RE: Letter of Authorization 

Dear Mr. Johnson: 

This letter authorizes Lewis & Hanison. LLC. of 122 C Street. NW. Suite 740. Washington 

D.C. 20001. to act 35 an agem on behalf of the following 2 EPA Company numbers: 

Lonza Inc .. 17-17 Route 208, Fair Lawn. NJ 07410 

and 

H & S Chemicals Division. clo Lonza Inc. 

17-17 Route 208. Fair Lawn. NJ 07410 

Company number 6836 

Company number 47371 

for all registration matters at the U.S. Environmental Protection Agency. 

• If you bave any questions. feel free to contact me at J-800 w 777~ 1875. ext. 2466 . 

Sincerely. 

rae+f\ IL~fV Ruth Trager ' 

Manager. Regulatory Services 

Te!ephone201-794-24CO .. Telex 1754539 ~ FCl:>: 20~·7t)4·2597 

A memher of !ht~ A,,1. \It::,Jl'.v,L~Hll'' CtlltlP 

•••••• 

• •• • • ....... • • •• 

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• • 

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• 

., . . , . · .. 

• ., . •• • • •• ., . . , . • •• 

""0 • • 

• • ••• 

••• utti!y 

• • •••• 

59 
• 

• 

.. -.-----------~ 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

LONZA,lnc. 

17-17, Raute208 

Fair Lawn. NJ 01410 

PRODUCT NAME: Dantochlor TBS~3 

COMPANY NAME: Lanza, Inc. 

OPP IDENTIFICATION NUMBER: 257090 

EPA FILE SYMBOL: 6836-ETO 

EPA RECEIPT DATE: 12/22/99 

12/28199 

SUBJECT: RECEIPT OF APPLICATION FOR A NEW REGISTRATION 

DEAR REGISTRANT: 

OffICE OF 

PREVENTION, p£snCIDEAND 

TOXIC SUBSTANCES 

The Office of Pesticides Programs has received your application for a new registration and It has 

passed an administrative screen for completeness. 

Please note that this Is only a notification of receipt of your application. This is only the first step in 

the application process, and does NOT constitute approval. 

If you have any questions please contact Robert Srennis, Product Manager 32, at (703)~08..s264 . 

Sincerely, 

l A~' )/-/ 

/ ' r..' 

~4l.0J j~ rx;~ 

.,...- Front End p,6:essing Staff 

I"foonatlon Services Branch 

Information Resources & Services Division 

Internet Address tURt) hHpollwww,oM.gOV 

Recycled/Recyclable Printed with Veo-table OU Based Inks on Recycled Paper (Minimum 25% Postconsumer) 60 

---~~-~-~-... -.~ ... ~.-. 
1~(fT 

• 

• 

LEWIS & 

HARRISON 

Con,ulta"t. In Ooverllfl'lfollt Aftoln 

December 17. 1999 

122 C Strm. N.W •• $u!t(l140 

Wurnl'lgfoO. D.C, 20001 

1~('I202,3&3.3go3 

lax 202.393.39!)JS 

U.S. Envirenrnen"'l Pretection Agency 

OffIce of Pesticide Programs 

Document Processlng Desk [APPL) 

Room 258. crystal Mall 2 

1921 JeffersOn Davia HIghway 

Artlnglon. VA 22202 

ATTENTION: Robert Brennls 

Product Manager, Team 32 

SUBJECT: LDNZA, Inc. 

Dantochlor rss.3 (EPA Reg. No. 6836-&0 ) 

HAND DELIVERED 

Appllcalfon for PHlleid. Registration -Now EllIt-I)se Product 

Dear Mr. Srennis: 

As agent for LONZA. Inc. ("Lonza"). we are submitting a reglslrallon application for. new end-uS<! 

peslicide product. Dantochlor TBS-3. This product is intended for sanitization 01 tollet bowl waler. 

PIe.se nole that Oantochtor TBS-3 is besically • dilution of Ihe reglslerad product. Dantnohlor 

re$>2 (EPA Reg. Ho. 6836-263). The Oantochlo, TBS-3 formulation is the same as that for 

Dantochlor TSS-2, with some Ust 4 Inert ingredients added to the composition of the tablet 

Product-specific .chemiStry and effICaCY data are being submitted to support the registration of 

DantochlorTB5-3. For tho ",malning data roqulremenls. Lanza is re;ying on tho cit_II mell10d of 

data support to register this new product and has issued offers of compensation to the companies 

appearing on the Data Submttters' Ust for the subject active ingredients. 

Plea .. note thai tho eflk:acy study (Sanitlzlng Properties !l! P[Q!lyet 89077 in Tgilet Bowl Walen 

being submitted in support of the registration of Oantochlor TaW includes product chemistry data 

on pages 126 through 136. ConsequenUy, pte .... forwat'd • copy of tho emcacy sl1Jdy to the 

product chemistry reviewer. We are Including extra copies of1he efficacy study in this sl .. J)!l'!i:s~ion 

package for your convenience, . 

Enctosed. pl ..... find the (ollowing dowment. to s\IPPort the reglstraUon 01 Dontochla, 1139,'\: .. ,. . 

1) Tran$mlllal Document 

2) Applicauon for Pesticide Registrallon (OPP ID. 261292). to whiCh is atlaChed.~ 9i>PY of flit 

Child-Resistant Packaging Certification and letter from Lonza authorizing l~"" !\-Harrison.oo 

act as its agent: 

PIlg'I!! f af2 

61 

.p 
• 

• 

3) Two (2) copies of the Confidential Statement of Formula; 

4) Five (5) copies of the proposed product tabellng; 

5) Certification with Respect to Citation of Data form; 

6) Data Matrix (both Public and Agency copies); and, 

7) Three (3) copies of each of the studies listed in the attached Transmittat Document. 

If you have any questions about the enclosed submission, please contact Siot Harrison or me at 

202·393-3903. 

Sincerely, /- ~,_,..cc_ 

Wendy A. McCombie 

Agent for, 

LONZA, tnc. 

WAMlwm 

Enclosures 

cc: Ruth Trager (LONZA, tnc.) 

OantochlOl' TBS-3 

..... ~. 

. ., 

· ...... . .. . .. . · ., 

.. .. .... ...... 

....... . . ....... 

., . · .. .. . • •• 

· ., • .... 

· " .,. .. P3ge 2 or2 
• 

• 

LEWIS & 

HARXISON 

SUBMISSION DATED: 

STUDY SUBMmER: 

SUBMITTED IN 

SUPPORT OF: 

EPA REGISTRATION 

NOS.: 

122 C Street. NW., Suito 7.10 

WlIsI'llnglon. D.C. 20001 

lelopnone 202.393,3903 

lax 202.393.3906 

0 

0 0 

0 0 

00 

0 

00 

0 

0 0 

0 0 

00 

0 

00 

0 • 0 0 0 0 0 0 • 0 0 0 

0 0 000 00. 

o o 0 

o 0 

00, 

o 0 

o 0 

••••• o 0 0 

•• •• 00 0 

o 0 

•••• 

EPA TRANSMITTAL DOCUMENT 

12117/99 

LONZAjlnc. 

17·17 Route 208 

Fair Lawn, NJ 07410 

Dantochlor TBS~ 3 

0 

0 0 

0 

0 

0 

,00 

Centoehlor TBS· 3; 6836· EJD (not yet assigned) 

0 

00 

0 

0 

0 

000 

REGULATORY ACTION: Application for Pesticide Registration of a New End-Use Product 

STUDIES SUBMITTED: 

STUDY VOLUME 1 of 2: 

STUDY VOLUME 2 of 2: 

COMPANY CONTACT: 

.(De~enlbe' 1.1999) by lewis & 

15 pages with a 34-page 

Confidential Alt,eh:me"L 

US EPA Guideline Sarle. 61, 62 & 63 

MRID Number. ___________ _ 

Protocol No. sP-saa;O-M, ~~~~~~~~~~~~~;r::~:~:~,~l~O:;nz. Lonza No. HPR..o004: 138 pages. 

OPPTS 810.1000 

•• • ••• MRiO Number. ________ ...;.: .';:'-:~. :~"':~ 

• • •• •• 

• • •• • Eliot I. Harrison • ••• •• 

Lewis & Harrison, LLC 

122 C Street NW. Suite 740 

Washington. DC 20001 

(202) 393-3903 

.. 0 o. 

0 0 

0 0 

0 

.. 0 

.. 

0 0 

0 0 

0 

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0 • 0 0 

0 0 0 0 

0 0 0 0 

0 0 

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0 0 

0 0 

0 0 

0 0 .. 0 0 

Page t 012 63 
• , 

'\( '\ 'OMBNo. 

..... UNITED STATES 1:r::CTION AGENCY 

0 401, 

.. --

125 .... 0:2;-';;;;;;;' ; "nd, . ~"" I 

I_S.J,"~ 00, t. 0Pi>E D ...... (l!tl1).UR! 

eertlfk:a1lon with Respootto Cllatton of Dota 

Inc. -17-17=:208. La n, NJ07410 : r",~ 

~. 0 .... I o....ob.r11.1888 

__ ~.) (IIOl" _"""""' ""'"'" ~ _4l)CFR Palt151i) _No"", 

DantochlorT1JS.3 

~:~~!.~ , or, , ............... on __ .you 

o tam I ~. 0.... C ... , •. NOflce. ..- list of COfTll)al1lQ$ sent offers of ~ (the Data 

I am _ IJ1e _mothoo or_ """ hove _ WiII1 

OUt forin a list of companies t6flt ~ of cornpenaafian (th6 

181 lam 

~~. 

= 0 ... Ma1ril<_ ....... be """'for ... _). • roQ!I em-(1J1e 0.... MilfIIx _ must 

{Requiled If Ltalng the dte-aD nwthod Of when using thade-all option under U1&:htiectiva method 10 SfItisfv one or Il1OI1:'! data requiretTlCtnts1 

181 I hereby ~ and agree let pay oompt'Ml5alion. to other peIWIl$. with regard to \he approvat of tt'Ifs appIfcaUon. !Q the &Jd8nt reqUited by 

FtFRA 

.... I cmIily ihatlhis owt",,'1on (Of .'-. !h. fmm for runogiUImllon. or ilIls Dais CoII-tn Notice 10 ~ by .. dala submitted 

Of cited In tim application for Ngistflltlon, the kmn for ~Ion. or th/tI Deta Cal1-Jrt response. In adQIUon, ifdte-3ll optkm under ~ 

lI*decl/ve method III indicated in Section 1, this application 1$ supported by afl d&1a in the Agency's files IMt (1) cc::moem tho propeflies or 

or an jden1ica1 or substantially similar prodOct, or one Of mom of the ingredients In thiS product; and (2) is a type of 

l"Cquired to 1;& submitted IJfider !he dQla nKtU~ in effect Off the date af approval of this ilppUcalfon if the 

SOUQhllhe initial regi$.tf8t1on 0( a product ofidenUcaf or- $lTntlaf oom~tio" and ltSe$. 

I cmIily tJmt for""'" __ .... '"""""O.d'" """""" OfIl1Is IlIgimIIIon Ofllllllgimlllon. lI1i1l 1 am the _at_Of .hal 

I havu obtalned the wntten penn15Skm of the origfnltl submftfer 10 cite tna1lWdy. 

I certify' that for each study cited In suppOrt of this regia1ration or remglstrafion that ia not an excIuaive use study. either. (a) I am 

tho otIglnal data submf1ter, (b) I have obtainrtd the writ«m permi$$iQn of the original data submitter to use this $fudy in ~ of 1hla 

appbtlon; (e) aM ",,,icda of "'glbll~y fllt _'ion hove oxpIlIld for ... SlUdy; (II)'" $tudy IS In !he ""bile ~:"'(ej I have 

notilied 

3(c){1){F} 

in 

and/Or 

wriIlriQ 

3(c}{2)(B) 

111. company 

of RFRA; 

I"", aubmItted 

and (11) to 

tho 

commence 

$tudy and 

negotIatJons 

have _ io (Q 

dQtcan10e 

to pay com_ 

the amount 

to 

and 

the 

teftt\§ 

exton. 

of 

requlllldJlY 

eompen~« 

~ 

any, to 00 

paid far the use of the study, •••••• • • • • 

I eertify that in all inst~ where an offer ofcompensatioo is required. copie$ of an of1ets. to pa1 ~ihd tvideru:e of lho. do!_ in accotdtlJlCC with ........ 3(c)(1)(F) _ 3(e)(2XB) of FIFAA at. a._ and witt be _IItIIIIIO ,ho! "l;Mcy"",," 

roqu<ISL Shoukli fall to _ sUCh evidence to ... fvJen<y upon _. I unde< .... <d .... the fvJen<y m!lY'inI_ ~rflPda.y. 

anoel Of wsptfl'ld the regi$tnlUon of my product in confomllty with FlFRA, ••••• • •• • • •• "! •• • 

I I have made on thls fotm and aU attachments to H.are tme. aocurat9 4n<lcom~ ... ....... m~ __ me, bo_bIe by line "'''''prisonmonto< ....... 

• •• • • • •••• 

-~'r-=-- - ~ A. McCombie,. Lawi&& Harrison-Agent forLONZA, 1m:. 

EPA FoMiID'44 

64 
.... . . 

- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

0 401M-,S.W. 

WASHINGTON, D.C. 20460 

CerlificaUon with Respect:to CItaUon of Data Attachment 

AppIicant'slRegistrant'$ Name. Address and Telephone Number EPA Registratlon Numbert File SymOOl LONZA Inc. -17 .. 17 Route 208, Fair lawn, NJ 07410 6836-_ (not yet ltSS/gnedj 

Active Ingredlent(s) and/or representative teat compound(s): Date 

I ,:~ 1.3~dIChloro"515~~~.thYlh~~I~~~ln Doclfnber17.1999 b 1 3.c:1lchloro .. S..eth 1 .. 5 .. meth Ih dantoin 

General use pattem(s) (list all those dalmed for this product U$ing 40 CFR Part 158) Product Name 

Indoor, Non..food Dantoc:hlor TBS-3 

COMPANIES SENT OFFERS OF COMPENSATION 

• 

• 

CHEMICAL CHEMICAL NAME 

028501 l,3-Didhloro-5,S-dimethylhydantoin 

COMPANY# 034697 

TRO-SAN PRODUCTS, LTD c/o MORGAN 

1800 M. STREET, N.W. 

WASHINGTON, D.C. DC 20036 

COMPANY. 063394 

CHEMICAL MANUFACTURERS ASSOCIATION (HASMUKH SHAH) 

1300 WILSON BLVD 

ARLINGTON VA 22209 

CHEMICAL CHEMICAL NAME: 

128826 1,3-Dichloro-5-.thy~-5-mothylhydantoin 

COMPANY# 063394 

CHEMICAL MANUFACTURERS ASSOCIATION (HASMUKH SHAH) 

1300 WILSON BLVD 

ARL!NGTON VA 22209 

••• ••• • •• • • 

•••••• • • •• 

••••• • • ••••• 

• • •••••• • 

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• 

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•• • •• • • •• 

• 

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65 
o 

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rw 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

D.C. 20460 

Information 

DATA MATRIX 

Product 

Inc. -17·17 Route 208, Fair Lawn, NJ 07410 

Ingredlent(s): fa) 1,3-dlchloro-5,5-dlme1hylhydantoln CASRN89415-87-2 

Series 62 

Series 63 

• • 

Form Approved OMS No. 2070-00a0 

assigned) Page I of~ 

Slgnature~ Name-and TItle: Wendy A. McCombie, Lewis & Harrison I bate 

Agent for LONZA, Inc. 12117199 

ep"FQime57Q..3SiH7IE~AI'KIPPiW~~ SubmIt<>nly ..... ~ -_Un 

ije'_ -j>, 
---------~-~~.~ .~-~~-.~.~~.~ 

o 

- UNITED STATI!$ ENVIRONMENTAL PROTECTION AGENCY 

401 MS_S,W, 

WASHINGTON, D.C,_ 

DATA MATRIX 

Prod"", 

Inc. -17-17 Route 20B, Fair lawn, NJ 07410 

'ng""'ItmI(.): Ca) CASRN 89415-$7-2 

- FOIm Approve!i 0M6 No. 2070.ooeo 

1. 

~ 

TtIMe_.,...,I_'red foraf1d.useprodud __ MlCFR Part 158.00. The """, __ for,.. reg\$lere'ho\lrteprodud, D<m1ochIor (EPA Reg. No. 6836-114), h ... boen 

submItted to EPA and shoUld already be on me, 

2:. OanlOchlor T88·3 is a sorid pmdUd. Themfofe, Ihtie dale 8Jtt nol taqwred under 40 CFR PM 158.190. 

3. DantodllorTBS-3 does FlO'! (;.OntaIn ,oy pol&nUa11y explosive components, TherefQ(e, theH data are f\Qt required 1I~ 40 eFR Part 156,190, 

• • • · ., • • • • • •• •• • • • • • ., • • • • • • .. .. . .. •• ... ... .. . ... .. • .. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • .. • • • • • • 

SIgnature-~ ./~ Nama ancf'l"itJ8:WGndy A. McCOMb&), Lowit & Harrison I""" 

Agent for LOHZA.1nc. 121171119 

kl'J\""''''IIS:m:&;fi'll)~_~~_ $l..«mofflj-~-'1t4~ ~~UH 
----------~-~ 

ft 

o 

Serias 62: 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401111_. S.W. 

WASHINGTON. D.C. 2048Il 

burden IQ: 

DATA MATRIX 

Lawn, NJ 07410 

Pmducl 

CASRN 11$.$2-5 

,~~---"" 

• 

Form Apploved OMB No. 211704)00 

~ J~"'U'II -~ 

C'., 1",- I OWN I 'JI I...... I"\IMkl 
I 

I 

or 

-

December 17, 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401M_.S.W. 

WASHINGTON. D.C. 20460 

DATA MATRIX 

EPA 

Product 

Inc. -17~17 Route 208. Fair Lawn, NJ 07410 

Ingredlenl(s): (b) 1,3¥dlchloro¥S.ethyl.S.methylhydantoln CASRN 118-52-5 

• 

FOfm Apploved OMS ~. 2070-0060 

Page 2ofa, 

1. These data are not required for end-use products under 40 CFR Part 158,90. The applicable data for the registered source product, Dantochlor (EPA Reg. No. 6836-114), have been 

previously submitted to EPA and should already be on file. 

2. Dan\oclllorT8S-3 is a solid product. Therefore, these data are not required under 40 CFR Part 158,190. 

3, Danlocl1lor TB~3 does not contain any potentially explosive componeflls. Therefore, these data are not required under 40 CFR Part 158.190 • 

• • • .. , • • • • ••• •• • • • • • ., • • • • • • •• • •• 

•• •• ••• ••• • •• • •• • • • • • • •• •• • • • • • • • • • • • • • • • • • • • • • • • • •• • • • • • • 

Signature ~ 

-r.:. .. EAA FC>'m 851().35 i9.91) EJeeIr<>no: _ P&(lCIr ~~, $IbM "*' P.,_. 

Name and nUe; Wendy A. McCombie. I..ewis & Harrison I Date 

AgontforLONZA, Inc. 12117199 

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• 

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· .. • •• •••• 

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• 
PRECAUTIONARY STATEMENTS 

IIAZARDS TO HUMANS AND DOMESTIC ANIMALS 

DANGER. Highly corrosive. May be latal if swallowed. DO 

NOT TAKE INTERNALLY. Causes eye and skin danlage. 

Irritatlllg to nose and thmu. A void breathing dust. 00 not 

gct into eyes, on skin or clothillg. Wear robber gloves whell 

hundling, alld wash thorollghly after handUlIg. 

FIRST AID 

If [II Eyes: 1·lold eyelids 0PCII and flush wilh a steady. gelltie 

stream of water lor 15lninutes. Get medical attention. 

Ifon Skill: Wash witll plenty ol'soap and Wllter. Gct medical 

attcntion if irritatioll persists. 

If Inhaled: If not breathing, give artificial respiratioll, 

preferably, mouth-to-mouth. Get medical attentioll. 

If Swallowed: Call a doctor or get medical attclltioll. DO 

NOT ittduce vomiting, Do 1I0t give altytllillg by Iilouth to all 

uncollscious person. Avoid alcohol. 

NOTE TO PHYSICIAN: lJrobnblc Ulucosal dmnage may 

contraiudicafe the lIse of gastric lavage. 

PHYSICAL AND CHEMICAL HAZARDS 

CHEMICAL HAZARD: STRONG OXIDIZING AGENT. 

Keep awny from heat or flaille. Mix only with water. 

• • • .,. 

• • • • 

• •• •• • 

• • • • •• 

• • • • • 

• •• ••• 

•• •• ••• . ,. ••• ••• 

• • • • • • 

•• •• • • • • 

• • • • • • • • • • 

• • • • • • • • • • ., 

• • • • • • 

• DAN'fOCIILOI< 'fIlS-3 

Ill-Ta/ik SallltltCr for Homcs, Sellools. umlllosPlltJl.t 

• 

hl-Ttillk Alltomatic Toilet BUil'l CleulJlzr 

SUlllrize$ Taj/et Bowl Jl'l.Iler Afler Etu:h Flush 

Kills 99.9% OJ Bactcria /II 70ilet bun1 WlIIf'J" Ajkl' Ecv:" FIUli/l 

ClewIS alltJ Deodorites Witl! Every FIllS" 

f/elps Keep YOIII' TVllet BOh1 Frc.tll alld Clean 

RccOIlIllIl!m/eu for freCJuemly j/llshed tollels 

Kill.t hacteria/or over 1III(IIIth 

Kms E. call 

KN/s Slopliylococl..·llS Iwreus (~'Iapll) 

Kais SulJllolII:/lu dw/urueslliJ; (.wl/liollclJu.) 

KiUs EJllerOC{){:clIsfiICI..·(llis (strep) 

Kif}.t /lseudolllomlS acrllghlOstJ 

Kills COIIWI/}/! hOll.'ie/1l111i huetcriu 

Kills vdor-t.:CJl/l'Ulg hm.:tl!rl(/ 

Active Ingredicllls; 

1 ,3~dielllo(o-5,S-dhnethylhydi'lntoill 

1,3~uiclllofO. 5-ethyl-5-meth ylh ydanloill 

luert Ingredients: 

TOrAL: 

52.7% 

to.5% 

36,8% 

100.0% 

MillilllUUI Available Chlorille 44.2'; .. 

KEEl' OUT Of REACH OF CIJILDREN 

DANGER 

UPA Registr.ltioll No. 

EPA Establishmeut Nu. 

Net Weight 

6836· ETO 

6836·PA-OI 

SO gl'alliS 

Motnulllclured by: 

LONZA 1111;., 17-17 Route 208, Fair LmvlI, NJ 070110 

. . Whellllsed as directed. Dalltochlor " TOS-3 will sanitize 

toilet bowl water, keeping it cleulI, clear alld free of odor. 

Dunlochlor 1'SS-3 gives the effectiveness of chlorine 

without the chlorine odor. 

Duntochlor TBS-3 sanitizes toilet bowl water by killillg 

99.9% of all bacteria within IS minutes after each flush. 

Each tnblet sanitizes for Olle month. Eliminates 99.9% of 

bacteria within 15 minutes after each flush. 

Remove (allk cover aud cut Opel I package. 

DI RECTIONS FOR USE 

It is a violation of Feueral Law to use this product in it 

mallner illconsistent with its labeling. 

To Sanitize, Cleall, alld Deodorize: 

t, Clean toilet bowl thoroughly illcluding ullder the rim. 

2. Remove toilet tank tOil. I-Iold plastic pooch away from 

filee. Cut pouch open wilh sci$sors on dolled lines. Do 

not (ouch tablet. 

3. Flush toilet. Before tank refills, hold plastic pouch 

over lallk and drop only the Dantochlor TBS-3 tablel 

into the right rear comer of the tauk. (See diagram) 

Discard plastic poueh and wash hands thoroughly. 

4. No removalttecessar)'. Each tabl~! sanitizes for one 

month. When tablet hIlS dissolved, replace with a new 

tublet. Producl $hould only be used in u. toilet that is 

flushed regularly. 

STORAGE AND DISPOSAL 

Store ill original cOlltailler ill Mcas iuaccessiblc to slilull 

children in u cool, dry, well-ventilated urea. Do not store 

at clcvl1ted temperatures. Discard empty cOlltniller in trash. 

Questions'} Conunents? Call (inserttelcplwoc nwllbcr here) 

'I1tis product contuillS ItO phosphates or phosphorous 

tompoullus. No mess. Does 1101 hunn plumbillg or septic 

tllnks. Conceltlrated. Leaves bowl 99.9% bacteria free . 

72 

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IIRECAUTIONAItY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS 

DANGER. Highlyeorrosive. May be flltal ifswallowcd. DO 

NOT TAKE INTERNALLY. Causes eye and skin damage. 

Irritating to nose and throat. Avoid breathing dust. Do not 

get into eyes, on skin or clothing. Wenr rubber gloves when 

handlillg, and wash Ihorooghly after hondling. 

FIRST AID 

If iii Eyes: Hold eyelids open aud nush whh a steady, gem Ie 

streom urw:uer for 15 mimlles. Gct mcdical3l1elltion. 

If ou Skin! Wash with plenty oholl" and water. Get medical 

llltentiou if irritutiOll persiSlS. 

If luhaled: Ifnot brcmhing, give artificial respinuion, 

prererably, /noutla-Io-moolh. Gct Ilu .. '{tiealalteution, 

IfS\Yllllowed: Call a doctor or get medie,:li anemian. DO 

NOT induce vomiting. Do not give anylhiug by mooth to <III 

ullconscious person. Avoid uicohol, 

NOTE TO PHYSICIAN: Probable nlllcosal damage tUay 

conrruindicllte Ihe use of gllStric lavage. 

PIIYSICAL AND CHEMICAL HAZARDS 

CHEMICAL HAZARD: STRONG OXIDIZING AGENT. 

Keep away froUl heal or flame. Mix only wilh Waler. 

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DANTOCIiLOIt TUS·3 

1,,-Tiltlk Sunitizer Jitr /JUIIICS. ScIt()()I.~. awll/f'JSpiltJls • 

In-Tallie. Autolllot;c Tuilet Bowl Cleaner 

SaIlW:f!s '1hi/f!t BOlY/lVU/(!r After Each Flush 

KUIs 99.9% Of Bacteria Itt Toilet B(Jlil WI/fer Alier Each Flush 

C/culls alltl DeOdOriU!l' !Villi Every Flush 

Helps Keep Your Tuilet Bowl Fresh 01/(1 Clean 

Recolllmend!!l) for jre11llelllly jllll'lwd tQi/ttts 

Kills btlcteria!oruwr I nI(IIliJl 

Kills E. coli 

Klflr Sfltll/a),loco(X'IIS llItr¢IIS (,f/upla) 

Kills Salmot/ellu d/tJlem/)$ItI~,. (salllllJlwlJl1) 

Kills E"terocaccl1s jaecalis (Sll'l!p) 

Kills 11:.euliottWlltls aef'lIgillo.wJ 

Kills cUI11I11()lIlwuselllJld bllctC1'ill 

hills odor-cul/silll! bw:wrait 

Active lug~edicnts; 

1;3-dicbloro-:5 ,5·di meth yillydantnin 

1.3-diclt loro-5-ethyl-5-methylh ydllnloin 

Inert Ingredienls: 

TOTAL: 

52.7% 

10.5% 

100.0% 

~ 

Miuhnum Available Chlorine 44.2% 

KEEl' OUT OF REACH OF CIIiLDREN 

DANGER 

GIlA Rcgislroltion No. 6836-

EPA Establislllllcnt No. 6836·PA·OI 

Nel Weighl SO gr.nus 

Manufactured by: 

LONZA Inc., 17-17 Route 208, I:air LillYn, NJ 07410 

., . When used as directed, Dilutochlor TDS-) will sanitize 

toilet boWl water, keeping it clean, clear and free uf odor, 

Dnntoehlor TBS·3 gives the effectiveness of chlorine 

without the chlorine odor. 

DantoCblor TBS-) sunitileS loilet, bowl W31(:r by killing 

99.~ of all bacteria within is minutes after eilch flusb. 

I!aeh tablct sanitizes for one monlh. Elimimlles 99.9% of 

bacteria within 15 minUles aCier ellch flush. 

Remoye lank cover and cot open package, 

omECTIONS FOR USE 

It is II violation of Federal Law to use this product in a 

manner inconsislcnt wIth its labeling. 

To Sanitize, Clenn, and Deodorize; 

I. Clean lOilet bowllhoroughly includiug lander the rim. 

2. Remove toilet tank lOp. Hold r!<lstic pouch away from 

faee. Cut pouch open with scissors on dottelililles. Do 

1I0t toudl loblet. 

3. Flush toilel. Defore tank refills, hold plastic puueh 

over tank and drop ouly the Dantochlor TDS-3 lablet 

into Ihe right reur come. of the tunk. (See diagrrun) 

Discard plastic pouch and wash hands thoroughly, 

4, No removal necessary. Each tablet sanitizes for olle 

mOUlh. When tablet has diSSOlved, replace wilh a new 

lablel. Producl should only be used ill aloUel tbal is 

nushed regularly. 

STORAGE AND DISPOSAL 

Slore in originnl comainer in arc-,s inacCl:ssible to smull 

childreu iua COOl, dry, well-velllUutcd area. Do nut stole 

at elevated temperatnres. Discard empty container ill trash. 

Questions? Comments? Call (insert telephone nwnw here) 

TIlis product eoutains no phosphates or phosphorous 

cOlllpouuds, No mess. Does not harm plumbing or scplic 

tanks. Cnneentrmed. Leaves bowl 99.9% bacteria free, 

t 1129199 Page I 1 and ( )= Denol!!$" nltcmalive/intcrcllRugable IUlIguage 

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*Confidential Statement of Formula may be entitled to confidential treatment*