SU BJECT:

**FRO~I:** Til 

### ROUCH: TO: IJiaTBI) STATIS IDIVDtOIIXBIIr.U. PIIOTIICTIOif AOlDICY WASHINGTON, D.C. 20460



# . (_/';{£

**~-.K.J** 

## (}«r .W"' MAR 1 

## 610\6 _ Review or Product ldcntil)', **~l:muf-x1urin'** 

### Pt'OC'CSS.. DUcvssion 

### ot Fonn.:ui.on or

**nintcntionoll ~imts.**  CmifiCIIion oflim i ts. Storoc< Sllbili l)'. pH, Acvte Toxicity Woi\'<t, oncl Tolcr.ln« E.x<mption 

### f0< Vomlmo \YSP (EPA Reg. No. 10CW4·11) 

### submincd by 

### Lhlochcm Inc:. Milut in S. Djurickovic:, M.S .. Biologi$1 Microbial Pdli<idos Dranth. Dioposlicid"'

**~vvv ''C-:;::~::::::::>**  

### Pollution Pn:\ocnlion l>ivision (7SIIC) ' John L Kouall. Ph.D. Senior Scicntm )<'C\9'(AA:A, 

# Dl•'"'"'"""' Microbiol Pesticides 8llll1Ch. Biopcsti •des Pollution Pmocntion Dhision (75 II 

### Mi<hocl MmcklsoM.

**~ory** •\ction 

### Lcad<T Microbial PC1liridcs Bllll1Ch, Biopaticidco :and 

### Polluti on Pm"Cntion Dhision (7SIIC) 

### SF. 

### F. CONFIDENTIAL UUSINF.SS INFORMATION ,\PPENDlX 

## • ' 

### ACTION REQUESTED: To 

### ,.,.;ow the Product Identity, Monufocturins 

### Process. DISC)JSSion of l ' onnodon ofUnintcntion.:ll lngn:dlcnL>. Certification oflimiiJ. SIOrliJIII Stllbility, pH, 

### Acute To.<icity Wol•·cr, oncl 

### Tolcr:mcel!.xcrnplion for Vomimo WSP (EM Rq;. 

### No. 706-l4-A) 

### submincd by l.idochcm Inc_ ond 

### pn,.ide o 

### risk 

### :wcssmcnt. CONCLUSIOI\': Acccpcoble, 1\<utc oro! oncl dcnnol 

### toxicity/polhoacnichy

**ICSiin~** 

### ofV:unimo WSP Ius sho\\1tlhol il is nottoxiclp>thoaalie. Acute cknnal initolion S)lllploms ploa:s 

### Vomimo WSP in Toxicity

**Cat~** Ill. The lnllbilily to do on 

### inhob!ion stud)' bcc>U$< 

### ihc product COIWiins 

### lara< uninhol>blc p:u1iclcs for lobclins purposes 

### ploecs 

### Ox: subswlcc In 

### Toxicity Cot<i<")' Ill. E.•posun: v;o 

### raidues .,;u occur, but there arc: 

### no expoctcd ossoci4lcd hozan!t. /Joel/Ius

**unl)follqu~/arlms** W PTA-1838 slf'Biru 1\n! Jn'';1.1ml in the cnvironmmt. M:m and 

### Mim3ls ;arc 

### likely exposed to these 

### boctcria on

**~ulor** b:uis. 

### The study results and 

### tho submlttccllitcr:uUr< 1suppon • toknmce <l<<mption. due to the likel y ropid d<.'Sf'l'btion ofthe b.>ct<rium from UV . rodiation. ''!'> ' inS cblly tmp<muRS. and lhc 

### L>c1 oft.W<it )i potl>osaliclt) ' ofthe ooti,·e in&(<dlent. DATA REVIEW RECORD Acthvlngrvdi<nl: /Jo<ll/us «m)iollqutfacltl" PTA-4838



### Pnod~~<t li:UD<: Vomimo WSP 

## l "' • Compony Nome Lidodtan Inc . R<jj. No:

**7~;\** D«lslon Number. 

### 495960 Submiuion Number: 95&317 DP 

### Bor<oclo:: 424151 MRIDsNo:4947UOito49474311 

### IIACKGROVND: l.ldochem Inc.. 1111s Jubmiutd an •1'91i<lltion to n.-aiSI<r Vamimo T tehnlo:olll.l and o tolcronte cxcmption petition oonaiolng lhc

**ot~i•..: ingrvdiau/loc//l~a**  tllff)iollqwfodau PTA-183 8. /loci/Ius um)follqwfucltns is • gt>111 posith" non·podlogcnic boct<rium which is commonly found in 

### the oir. wot<r, soil. ond on plmtu. D. **Olll){ollq~~<fa<irm** is ustd to pnoducc protCOJ)1ic cnzymos for l ow-odty 

### dot<racnt.s. is ustd In bntil<r ft<d ..

### o problotic. and produces <hltinosc. 

### Jllll'CIS<,IIlld lipu<J "llklt suppr<sscs fungi ond nematodes. A ..,...,t taxonomlc study pro\id<S 

### SUJ1110ft for n:dassif) i ng D. subtll ls '"' · DM ) foll qutfodors"" • 

### new spc<i<s 11«11/us tJm){oliqutfodtns. Vomimo WSP is • fun&Jd6c and nematode SUJ'P'<S"'ntlhot""" he ustd on oil c rops inc luding omomcn10! and turfo1'91icotioru: Vomimo·WSP <An he 

## •l'!'li<d via sproy to foli"lje. so il. or turf: di1'9ing ordr<nchlna 

### root.s. os culling ond 100( dips. ....., hij«<ion, hydroponiCJ. 

### soil lncorporDtion, cbomiptlon ,; . sprinkler. drip. flood. olonc or in combination \\ilh olhcr ftmti<id<S. and as o plant 1)10\\111 prorndcr . I n -hoflhes< IIJllllicalioiis 11«11/U> atft){ol / qwfodms PT A

-1 8)8 iJ

**cxp«~td** lo d<snode ropidly from cxposuroto UV rodlotion. **pr«ipiiOtionlinig~ion.** ond \'Ot)i na doily lcrnpcnnurcs. In ShU31ions

**\\~** appllaniOf\S D1'C closer lo h#\ ' CS:It irMS. n:sidueJ on crops are expccttd to he hiaft<r than normal bockaround 10\ •c!J. llo""''"·lhe product iJ not **to•iclpo~enic** ond is not e<pccled 1o ......, od\'Cf1C heollh effects. DISCUSS ION: The l'nod uct ldenlil) ', M onuf octurlnll PJOCCSJ.I.JiJcussion of formation ofUnintcntionollngrvdlcnts and cmtr...u.n o(Limits .....D U l (IICiory. Stonae Stobllit y ond Cortosi011 

### ClwliCiotlstics. ond pll studies, Ac:ute E)'< ond Acute Dennallrritalion In 

### Rabbits. ond P,..,. ond P0>1·To,icity

**An.11) is**  of Aclh'< lngrvdient (Mute T<Wcity ond lnholallon) .,..,. complete ond accqllllble . Acutc Oral Toxicity (Ul>P) ond Acute 

### Ocrma1 Toxlc:ily in Rot $1udl01 wm: Ot<epiOble.

**h<m'l:\~r .**  a primary irrit.:llion of0.2 out of8.0 was rcconkd

**~** I hour ol\eropplialtion for the tcstsubslant< in 2lhc oculc dcnn•l robbil sludy. In lhc >ludy Vomimo WSP \\'IU •lighlfy l rriuuinll- bu1 b considered irriblins boalii5C oflho dclo)'Cd S)mploms INI"""""""' in lho lonsor·lc:nn lrri..Uon in lho ocutc donnolloxicily ra1 Sludy. The fcm:>lc '""opcricnc'Cd Ery1hcmJ1 and A lope< Ia. while rru>lcs c.<pcri<n«d l!l)'lhc= Ocsquamolion, Alopcclo, and A IoniA. Most n<Mhly, no S)mplom.s

**"~~** m:onlol un1il O:.r 7 , lndicotina !hatlho tcSianl rru>ls m>y M'< cxpcricnc'Cd o dcla)'Cd reaction 10 lho 10>1 sub.>IMCC. The produc1 b considered 10 

### 1>: in EI'A To.<iclly Colq;OI)' Ill boalu;c oflho 

### nxordtd denn31 init.1tion. 

### The common ptU<:nCC 

### or 8 . **um)lollt~t'tfi~eltltr** 

### in soiiJ and ugriadtunll cnvironmcnts supports the a.muuplion tltol humons 

# =

**li~cl y**  cxpc>JCd 10 lho bxccrlum on 4 quf.v bosls. ,. .... or 8. **Otrf)~OI/qU<facltn•** PT A-1838 ...Spr.l) ' 10 foliose. 

### soli, or 

### tun : dipping 

### or drmchins 

# roots, •• CUl ling ond roo1 dips.

**t~e** injecllon. hydroponics. soil incorpor3rion. chcmig:ttJon 

### \ill sprinkler. drip. 

### flood. olonc 

### or In 

### comb!notion wilh Olhcr funpddcs. and 

### os • pl:llll i10"1h

### prc><nOCcr. llUMMARY OF DATA

**SU ~I!TTI\D;**  S!arau Srab!lll\ •ud Carmloo Cha!l!ct•rl•fln

# ••4 pH: (MRID •

**~9~ 7~302**  & **~~7~JOJ)** Tabl I c • Act.i\'c t

**~I** 

# •• I . cnl **An~~~h'SIS** Obscn'llllon

**Acth'el n~** 

**l** Period CFU/a Month 0 9 . 1. 

## 10' Monlh3 6 .7 

### x 

## 1o·· Mon1h6 

### 4. 8x 10' Monlh9 1 . 1 

### x 

## 1o•• Mon1h 

## 12 s.o. to" I """ MAID
**·U~JOJ** 

### Umsc:linc 3.Jl.lllysis c:onduclc:d ::s.t 

### Month 0 cklmnlncd the ll\'mi.S,C 

### acth· c ingn.-dicnt control orthe 

### test >UMI>n<< lobe 9.8 X 10• Colony Form

**In~** Units
**(01))1~** Aml)'>b cooductol at Monlhs 3, 6. one! 9. dctcrm lnol lho ICSI subsc•ncucti>'< incrcdicnl con1cn110 

### 1>: 6.7 x 1010 .4. 8 x Ia'•nd 7.7 x 101 0 CI'U/g. re$pc<li>'Ciy. Tcm1inolonalysiJ coodCKttd ol Monch' t2 dctcnninol lho '""' sub:sbncc co con!Oln **oppro.•lm>~dy** S.O• to' CFUI&o oct i Vc **incrcdi<tl~** Yoilh pii)'Sicul Obscn'l>lions "'' U

h 'Dicnllo 

### b»eline descripti ons. nvatw.tions on COI1"'Sion charatiCTistks

**"~** 

### delamintd conc:urmu 10 srobilhy ...,pllnp. Throughout 

### !he dunlion oflhb srudy. no obscr.-ablc 

### <honi<s co lho ptoduct 

### conW.nu or **con.l.oi~** 

### coupons \\"tte: obsm"td \\ith 

### tht cx«p&ion orslldlt
**w~ialu** 

### fluctu;uions. Both conbincr and 

### coupon sampl'"' **maint..i~** 

### physical <kscriplions
**~uh'lllcnt** 

### to baseline: obscr\-ations. In conclusion. the 10>1 subsbncc, Vomimo'w \VSP. ""' dct<n11inol Ia be S14blc sho"ina no 

### sisns of C<MTOSion lifea 12 Monw ofSlorosc at 20"C

**'C).** The '""' subsbncc is sable ood non· **corrosi,~.** 3pll The test wbouna:, Vomimo WSP. ""' 

### ........S for its chcmial cb=<1m.ti<: of pH : The pi! of a 1% (w/v) **prq>oru~ion** ofVo.mlmo WSP in distilled water 

## \\uS determined to 

### be 4.90 ototest tanpcroluno of25°C. ' Ptndmcig: 

### None. C !.ASS !fi CATIQN; Aec<ptable AC IJT F, TOXICITY STUD If$ ASI!!C On!Ioxlcin• fUQPI 

### !g Rou; (MR IO • 4947431>1) All test anim.ts pined wclght during the study. No monalitics ocauml. and no ol>normalitlcs wm• obsoni:d. lndhid.. l 

### nec . ropsles ot the tmni.no1ion ofthe study potl\ided .-idcnec !hot no obno...,litics 

### C>mlll<d. The ocutc on! LO,. for Vllt11imo WSP,Indialted by lhe cbllt. is dclcrminod to 

### be
**~tcr** 

### thon SOOO 

### msfkg in f<ml!lc albino rots. DsOsico<i a : The n:siJUMI did 

# not...,..,... why lhen: 

### it such 

## •Wac dirr....,.,., bclwccnlhe pbte <'Ollllts oflhe

# octJ,.., inJ;Rdim t inpot and posttt,.icity t<llint 7. 6 

### x 10• pn:otoxkit)' CFU/a per Ccrtinc..te ofAnol)'1is Moy 6. 2013. PosHoxKity 7.6 

### x 101 CFUfg per Ccrtlllcate of•WlyslJJuly 

### II. 2013. This infonnation 

### docs not impact the **risk....,...,..,~** it is merely confirmatory, bcco.,. the CFUJg ore otllftd obo•'< lhe CFU'sl& colhe 

### lo be . ! for-. CI,A!!Sif!CAI! ON: **Aoecp~>blc.** The "'Jistront must submit on exp4onotion os t o why ther<ls such ol:u;c dlrr...- bclwccn lhe p l o

tc 

### couniJ of the acth" 

### !narcdlcnt in pot ond po>< toxicity t<llins. 7.6 

### x 

### to" P"'·toxlch)' CFUI» 

### pcr Cenifioote orAnoly$\s Moy 

### 6. 2013. Post•toxicity 7.6 

### x 10 11 CFUia pcr CmificoteofAnoi)'SiJJuly 11.2013. To.xieity cat<I:O')·IV. 

### Anne D£rmo1 ' roals!ll·- R!!i 

### (MRID # 49.174305) The mk\\'<r
**a;~** "ithlhe study author that the dcrmlll LDJO for males. remotes. and combined 

### sexes .....

### >. SOSO msfkg bw. No mortality",.. reported durini lhe 

### counc oflhe study . Etythcrno. Ocsqtwnatlon, Alopccia. and Atoni• """' obscn'<d"" I orlhe I<Sl 

### animals

**>~ith** 

### no d...,...e jUn<mby 

### day 14 . The female rots c:xpcricnocd EI')1IICTIIO ond Alopccla. wbllo mole$ oxpcrien<ed Etythcmo. Desquamation, Alopecia. and 1\tonla. MOll notably, no5)11\JI(oms """'r«<RRcd until Day 7, i nd icatin g 

### thot the t<Sl animals may 

# ba,, ••pcricn<cd a dclo)'<d rcution 1o lhe t<Sl JUbslonoe. For lobe !ins 

### J'lllliOS<S. this p*<slhetcsi su""- In To.deil)' Cateaol')' Ill. Pdkl..,<ls! : The n:aistrant did not oddr<SS ""hY lhen: is •uch alarsc dlrrm:n<e 

### bot"'Ccn the plote counts or the octi\'CinJ;Rdlcnt in pot and posato.•icity IC>tint 7.6 x 

### to" pot-t oxicit y CFU/g pcr Ccrtifieot< or
**Anol) is**  Moy 6. 2013, POSI·to•iclty 7. 6x 101 CI'Uis p:rCm lf1a11e orAn>l)'1is July 411,2013. Cl.ASSIF!CAT!O,'I: Attq>IAble. 

### The: qistr.ant mUSl >ubmit on CJCpbn>tion osto "ny lh= is such •

**'"'~~"** difTmncellclwecn the plate counuofthex ti'" iJw<dlent In pre ond post COl<ieity tosting. 7 . 6 x lo" pre·loxidty CFU/jj per Cmifocateof Anol)'Sis May 6. 201 J. This infomllltion does nlll impxt the 

### risk

**osscssmcn~** It 

### b mcrcly t:Onfirmotory, 

### bc<:aUSC! the CFU/g""' 01 and 

### obo\" the CI'U'slg 

### on the label for 

### use. Po>t·toxlclty 7.6 x 1011 CFU/a per Certificate ofAnolysis 

### July II, 2013. Toxicity cutegOI) ' Ill . Asutr lnhol•don T•Y!sUy In Rolf- Waktr Rsguqt; (MRID N49-174306) A '""''"n.'quest hos 

### bc<:n JUbmitt<d describioa that the gnnuln of Vamimo WSP 

### ore too 

### large to ochi<'l · c • meoningful

**i~on** dll4 set. 

### The: OPP Guidlncc for Woivlna or Bridsins Aoute T

### oxicily Studi ..

# =cs""" the rq:lslr.lnt 

### muse

# -tc that the pnlduct 

### <Onuins 

## 1"'11" noninluloblc p.midcs 

### " tuch.,.. rui>bnt to attrition. 

### The: rq:isvant hos dcrnonstralCd the produet could not he funher ground into sm311cr p.m ick si7.cs. Since the pnlduct could 001 be tesl<d, for lobellny ptRJII>SCS, this ploccs the study in Toxicity Category Ill. O(Odcndq:

**N~.** C!,A$SIFICA TION: Mccptablc. Toxicity cutcgory Ill. ,\cu ts F.n Irritation In Robblh; (MRID N49-174307) No morulity OCC\ltfCd duri"l!the study. Bos<d on the ='<imum

**"'~** lrriwlon ... .., ofO.O. test

**~** V:unimoDI WSP i s r.ued non-irril:l.li"a. SiTICC' thac v.'fte' no poshl\"C cff«1S during 1M study, the test subston<c is :wian«< TC!l<iclty C.tcgory IV for'>" irriution. l!tOslmM: None. C I.ASSIFICt\TIQN: Acseploblc. To . <i<ity ca\CG011' 1V. 

### AsU!< Orrma! Irritation In Rabhl!<; (MRID # 49474308) A primary initotion of0.2 out of8.0 WIIJ m:or&:d :lt I hour aftcr application

**lOr~~** lest substa.ncc . In this study Vomimo WSP 

### wa• sliahtly

**irritotin~** but is consitkred irriwlna 

### bc<:owc ofthe

**tklo)~** S)'mpto ms thot appcored in the lon;«·t<rm irrilotion in the O<Ut< d<mW IO.'<iciiY rot study. 

### The: female rots cxpcricnccd Et)1bcmo ond Alopc<io, \\hile 

### =ks apcricnc...d El)1l>ccm, 

### Dcsq=lion. Alopcci&. ond 1\tonio.

**MC~Sl** Dlllably, no S)'lllploms wm: ..,..lded unu10..y 7, inditat ins t h:ll the

**~est** 

### :anim:ds .my hl\-c

**~pcrimo:d** a debyaf rcattion ao the tCSl subsJ.ucc. 1"be pn>duct is

**co~** to he in m> A Toxicity C.t<gol)·lll. Drfklrncla: The "'YlsltM\ did not oddr<ss why there is such • 

## Iars< d lfTcren<e bet\\ttn ths plotc counts ofthe 0$11\.., insmllcnt In P"' and post toxicity tcstina. 7.6 x 

## to •P"'·toxlcity CFUfg per Ccnlli<Otc of 1\nolysis May 

### 6, 2013. Po:tt·toxicit) ' 7.6 1011 CFU / s p:r Ccninca le ofAnalysis July 

### sII. 2013 . Additionally, 

### an<C1'0psy \\1U nat pcrl'orm<d 0<1 the t<SI :mirr111llhot died during the Slud )'.



## . 

# . CI.A!iSif iCAT!ON: A«<ppllblo. The reai>lnlnt mull submit., cxpbn:llion oslo why 

### Ibm is such • 

### lor&• dUTcr<ne< h<lw<xnlhc plato counts oflhc oc:d\'Cinll!"'lcnt in pn: 

### ond post to."<icity tcsaina. 7 . 6 

### x 10' pn:-toxkil)' CFU/a 

### per

**Catlfia~c** ofAnalysis Moy 6. 2013. Post-toxicit)' 7.6 1011 CFVIs 

### per Catlfkol< ofAmlysis J uly II, 2013. Toxicity at<iO')' Ill This inf.....wion doos 1101 impo<llhc risk 

### uscsomcm. it is monolyconfinnatmy. hcaaut<lhc CFUig""' at 

### ond oho•'Cihc CFU'sts on the l•bcl for 

### we. Dsfirisnslss : None. C ld\SSIFI CA TION: A«<ptablc p,.... oad Pnt-To!ldty AnaM!s o! Assh=slngm!iml CAnts Toll: (MR!D M 49474310) Vomimo WSP (0.29% Bocil/UJ
**om)4ollq~Kfac/<IU** suoin PTA-483& I x 10 11

**CFUi t~**  **).** l.otlllotchiiD Number: 2218216. 7.6 x 

### to' p«-toxlcit) ' mumsn.tion with plotlng CFU/g psr C<rtilicotc ofAnalysis,\!'ril30, 2013 and plate count on

**~by** I, 2013. Post-tox icity mumsn11ion \\ith platin; 7.6 x 1011 CFUig per Ccnlnaotc ofAml) • ds June: 26, 2013 ond plotocount on 'June 27, 20!3. Ps!i<lm<IH: N..,. .

**CI,AS.~IFlCAJ ON:**  Acccp44blo 

### Prs- ond Poot·T•:!Iri!r Aa.oly!lt of Astb•slncrcdlm!lt\sul<lnho!at!gnl: (MRID N

**4~74311)** Thcxt.i\-r ina,rcdimt OXJlCDl ofVomimonl WSP (rom p l atin;eon April30. 2013 W3J 6.8

**~** 10• CFU i g ond the 

# octi'" ingmli mtC\l<11all (1\ltn ploting 

### on December 12. 2013 

### "u 6.2 

### x 1010 CFVIa. OeOdsnslp; N"nt. CLASSI FICATION: ,\ettptoblc CONCLUSION: A«q>l1bl<. Acvtc oro! and dernW toxlcit)1p>thogcnicity ICOil ng ofVomimo WSP has shown !hot it is 1101 to>ldpolloogcnic. Acuu dernW 

### Irritation symptonu places Vamimo 

### WSP in ToxicityCat<s<>«)' ln. The inal>ilhy to do :tn ini1Alotlon study 

### because lhc product 

### c:ontoins 

### lor&< unini1Aloble pottict.._ for labclina pllt!l<l5CS ploccs lhc substance in Toxicity Cotq;ocy Ill. 

### E."q>Osure via n:siduco \\ill 

### occur, but then: on: no expected os>ocioted 

### lw:ards. Bocl/lus OIH)1ollqU<foclttts ond PTA-4838 strains are pm'lilcnt in lhe cn•·ironmont. Man ODd onimols""' likdy exposed to these boct<N on

**~ular** bosis. The stud) ' results ond the submitted lltcroture support •tolcnncc cxcmptlon. d11010 lhc likcly "'f'id dq;n>dotion oflhc ba<lerium f"'m UV r.>diotion. "'')ina daily l<mpaol.,... and lhc lad; oftoxicitylp:olhogmicity oflhc 

### OCIJ, ..ingmlleftL 6DroiT.<:. J.ll .• 

### Woodwo.nl. G. ond Col\-ny. H . O. ( 19-1-1) Mcdlods (O< the >tudy orinitotlon ond toxicily orsubswlcu oppli«< topically to the 

### sk in ond mUCO<OS mcmbr.lnes. J. Phonnxol. 

### Exp. Thor . 82 :377·390. Guid>ncc 

### fur Wo.h · ing 

### or

**Bri dsin~**  

### ofMornmo l ion

**Acu~** 

### Toxicity. Tou (O< 

### Paticidcs ond 

### P<11icidc Producu (Mute 

### Or.U. Mute D<rmol. Acute

**l~ion.** 

### Primory E>"· l'rim:uy Ocrmol. ond Ocrmol Scns.iliz:uion). 2012. QJ>P . Tal boys PJ. Ow1.-n DW,II<Oicy JR. Wilhcn I 'J. Jones DL

**201~ .**  Au.,in K<n:lion by lla<I/Jus OM){o//qrt<fucltns F'.lll-12 both otimubtes root exudation ond lim i ts phospiloNS 

### uplllkc in 

### Triticum tt<MIIvnr. BMC plont 

### bioiOS)" 14: Sl .

1

### fl i'R.\ CUIAPI'E i 'ID J X

8