SUBJECT: 

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 of limits. Storoc< Sllbilil)'. pH, Acvte 

Toxicity Woi\'<t, oncl Tolcr.ln« E.x<mption f0< Vomlmo \YSP (EPA Reg. No. 

10CW4·11) submincd by Lhlochcm Inc:. 

Milutin 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 

Pollution 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< 

1 
suppon • toknmce <l<<mption. due to the likely ropid d<.'Sf'l'btion of the b.>ct<rium from UV. 

rodiation. ''!'>'inS cblly tmp<muRS. and lhc L>c1 of t.W<it)ipotl>osaliclt)' of the 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 Ttehnlo:olll.l and o tolcronte 

cxcmption petition oonaiolng lhc ot~i•..: ingrvdiau/loc//l~a tllff)iollqwfodau PTA-1838. 

/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 low-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)ing D. subtllls '"'· DM)follqutfodors"" • new spc<i<s 11«11/us tJm){oliqutfodtns. 

Vomimo WSP is • fun&Jd6c and nematode SUJ'P'<S"'ntlhot""" he ustd on oil crops including 

omomcn10! and turfo1'91icotioru: Vomimo·WSP <An he •l'!'li<d via sproy to foli"lje. soil. or turf: 

di1'9ing or dr<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. In -h oflhes< IIJllllicalioiis 11«11/U> atft){ol/qwfodms PT A-18)8 iJ cxp«~td lo 

d<snode ropidly from cxposuroto UV rodlotion. pr«ipiiOtionlinig~ion. ond \'Ot)ina doily 

lcrnpcnnurcs. In ShU31ions \\~ appllaniOf\S D1'C closer lo h#\'CS:ItirMS. 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. 

DISCUSSION: 

The l'noduct ldenlil)', Monufocturlnll PJOCCSJ.I.JiJcussion of formation ofUnintcntionollngrvdlcnts 

and cmtr...u.n o( Limits ..... DUl(IICiory. Stonae Stobllity 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\er opplialtion for the tcstsubslant< in 

2 
lhc oculc dcnn•l robbil sludy. In lhc >ludy Vomimo WSP \\'IU •lighlfy lrriuuinll- bu1 b considered 

irriblins boalii5C oflho dclo)'Cd S)mploms INI"""""""' 

donnolloxicily 

in lho lonsor·lc:nn lrri..Uon in lho ocutc 

c.<pcri<n«d 

ra1 Sludy. The fcm:>lc '"" opcricnc'Cd Ery1hcmJ1 and A lope< Ia. while rru>lcs 

m:onlol un1il 

l!l)'lhc= 

O:.r 7, lndicotina 

Ocsquamolion, Alopcclo, and A IoniA. Most n<Mhly, no S)mplom.s "~~ 

10>1 sub.>IMCC. The produc1 

!hat lho tcSianlrru>ls m>y M'< cxpcricnc'Cd o dcla)'Cd reaction 10 lho 

nxordtd denn31 

b considered 10 1>: in EI'A To.<iclly Colq;OI)' Ill boalu;c oflho 

init.1tion. 

a.muuplion 

The common ptU<:nCC or 8. um)lollt~t'tfi~eltltr in soiiJ and ugriadtunll cnvironmcnts supports the 

Otrf)~OI/qU<facltn• 

tltol humons 

PT A-1838 

= li~cly cxpc>JCd 10 lho bxccrlum on 4 quf.v bosls. ,. .... or 8. 

CUlling 

... Spr.l)' 10 foliose. soli, or tun: dipping or drmchins roots, •• 

flood. olonc 

ond roo1 

or 

dips. t~e injecllon. hydroponics. soil incorpor3rion. chcmig:ttJon \ill sprinkler. drip. 

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 c I • Act.i\'c t ~I •• cnl An~~~h'SIS I . 

Obscn'llllon Acth'eln~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 

>UMI>n<< 

Umsc:linc 3.Jl.lllysis c:onduclc:d ::s.t Month 0 cklmnlncd the ll\'mi.S,C acth·c ingn.-dicnt control or the test 

9. dctcrm

lobe 9.8 X 10• Colony Form In~ Units (01))1~ Aml)'>b cooductol at Monlhs 3, 6. one! 

lnol lho ICSI subsc•ncucti>'< incrcdicnl con1cn110 1>: 6.7 x 1010.4.8 x Ia' •nd 7.7 x 1010 

con!Oln 

CI'U/g. 

oppro.•lm>~dy 

re$pc<li>'Ciy. Tcm1inolonalysiJ coodCKttd ol Monch' t2 dctcnninol lho '""' sub:sbncc co 

b»eline descript

S.O • to' CFUI&o octiVc incrcdi<tl~ Yoilh pii)'Sicul Obscn'l>lions "''Uh'Dicnllo 

srobilhy 

ions. nvatw.tions on COI1"'Sion charatiCTistks "~ delamintd conc:urmu 10 

conW.nu ...,pllnp

or con.l.oi~ 

. Throughout !he dunlion oflhb srudy. no obscr.-ablc <honi<s co lho ptoduct 

conbincr and 

coupons \\"tte: obsm"td \\ith tht cx«p&ion or slldlt w~ialu fluctu;uions. Both 

In conclusion. 

coupon sampl'"' maint..i~ physical <kscriplions ~uh'lllcnt to baseline: obscr\-ations. 

C<MTOSion 

the 10>1 subsbncc, Vomimo'w \VSP. ""' dct<n11inol Ia be S14blc sho"ina no sisns of 

corrosi,~. 

life a 12 Monw of Slorosc at 20"C 'C). The '""' subsbncc is sable ood non· 

3 
pll 

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!fiCATIQN; Aec<ptable 

ACIJTF, TOXICITY STUD If$ 

ASI!!C On! Ioxlcin• fUQPI !g Rou; (MRIO • 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 of the 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<ia : The n:siJUMI did not...,..,... why lhen: it such •Wac dirr....,.,., bclwccnlhe pbte 

<'Ollllts oflhe octJ,.., inJ;Rdimt in pot and posttt,.icity t<llint 7.6 x 10• pn:otoxkit)' CFU/a per 

Ccrtinc..te of Anol)'1is Moy 6. 2013. PosHoxKity 7.6 x 101 CFUfg per Ccrtlllcate of •WlyslJ July 

II. 2013. This infonnation docs not impact the risk....,...,..,~ it is merely confirmatory, bcco.,. 

the CFUJg ore otllftd obo•'< lhe CFU'sl& co lhe lobe.! for-. 

CI,A!!Sif!CAI!ON: Aoecp~>blc. The "'Jistront must submit on exp4onotion osto why ther<ls such 

ol:u;c dlrr...- bclwccn lhe plotc couniJ of the acth" !narcdlcnt in pot ond po>< toxicity t<llins. 

7.6 x to" P"'·toxlch)' CFUI» pcr Cenifioote or Anoly$\s Moy 6. 2013. Post•toxicity 7.6 x 1011 

CFUia pcrCmificoteof Anoi)'SiJJuly 11.2013. To.xieity cat<I:O')·IV. 

Anne D£rmo1 'roals!ll·-R!!i (MRID # 49.174305) 

The mk\\'<r a;~ "ith lhe 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<m by day 14. The female rots c:xpcricnocd EI')1IICTIIO ond Alopccla. wbllo mole$ oxpcrien<ed 

Etythcmo. Desquamation, Alopecia. and 1\tonla. MOll notably, no 5)11\JI(oms """' r«<RRcd until 

Day 7, indicating 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*<slhe tcsi 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-toxicity CFU/g pcr 

Ccrtifieot< or Anol) is Moy 6. 2013, POSI·to•iclty 7.6x 101 CI'Uis p:rCmlf1a11e or An>l)'1is July 

4 
11,2013. 

Cl.ASSIF!CAT!O,'I: Attq>IAble. The: qistr.ant mUSl >ubmit on CJCpbn>tion osto "ny lh= is 

such • '"'~~" difTmncellclwecn the plate counuofthe x 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 of Anolysis July II, 

2013. Toxicity cutegOI)' Ill. 

Asutr lnhol•don T•Y!sUy In Rolf-Waktr Rsguqt; (MRID N 49-174306) 

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 ox icily 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.mick 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 N 49-174307) 

~ 

No morulity OCC\ltfCd duri"l!the study. Bos<d on the ='<imum "'~ lrriwlon ... .., ofO.O. test 

V:unimoDI WSP is 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. 

CI.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 of the tklo)~ 

S)'mptoms 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, 

inditatins th: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< dlfTcren<e bet\\ttn ths plotc 

counts of the 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 Ccnincale of Analysis July 

s 
II. 2013. Additionally, an<C1'0psy \\1U nat pcrl'orm<d 0<1 the t<SI :mirr111llhot died during the Slud)'. 

. . CI.A!iSifiCAT!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 of Analysis Moy 6. 2013. Post-toxicit)' 7.6 1011 

CFVIs per Catlfkol< of Amlysis July II, 2013. Toxicity at<iO')' Ill This inf.....wion doos 1101 

impo<llhc risk uscsomcm. it is monoly confinnatmy. hcaaut<lhc CFUig""' at ond oho•'Cihc 

CFU'sts on the l•bcl for we. 

Dsfirisnslss: None. 

Cld\SSIFICATION: 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 1011 CFUit~). 

l.otlllotchiiD Number: 2218216. 7.6 x to' p«-toxlcit)' mumsn.tion with plotlng CFU/g psr 

C<rtilicotc of Analysis,\!'ril30, 2013 and plate count on ~by I, 2013. Post-toxicity mumsn11ion 

\\ith platin; 7.6 x 1011 CFUig per Ccnlnaotc of Aml)•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 platin;eon April30. 2013 W3J 6.8 ~ 10• 

CFUig ond the octi'" ingmlimtC\l<11all (1\ltn ploting on December 12. 2013 "u 6.2 x 1010 CFVIa. 

OeOdsnslp; N"nt. 

CLASSIFICATION: ,\ettptoblc 

CONCLUSION: A«q>l1bl<. Acvtc oro! and dernW toxlcit)1p>thogcnicity ICOilng 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 

6 
DroiT.<:. J.ll .• Woodwo.nl. G. ond Col\-ny. H.O. ( 19-1-1) Mcdlods (O< the >tudy orinitotlon ond 

toxicily or subswlcu oppli«< topically to the skin ond mUCO<OS mcmbr.lnes. J. Phonnxol. 

Exp. Thor. 82:377·390. 

Guid>ncc fur Wo.h·ing or Bridsin~ ofMornmolion 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 limits phospiloNS uplllkc in Triticum 

tt<MIIvnr. BMC plont bioiOS)" 14: Sl. 

1 
fli'R.\ CUI API'Ei'IDJX 

8