f.~IOBAI'!DUM 

SUDJF.CT: 

FROM: 

TIIROIJGII: 

TO: 

'OIIITED STATES BIIVXRONNIIIITAL PROTIIC'I'l:ON AGENCY 

WASHINGTON, D.C. 20460 

!WI I 6 1.016 

Ro-.icw of S Botch Enumcrotion. Product ChcmlJuy, MllllufociUiina Process. 

SIO<Oi< Subillly. S>mplc l)ijposilicn. Dl$cussion ofF0<m31ion ofUnintcntion>l 

Ingredients. Ccniflcolioo ofl.imils, Acute Toxklly Studies, and Tolmncc 

E.'"mptlon for Vnmlmo Tcchnicni (EM R<i- No. 70644-L) Vomimo ST (f:PA Rqj. No. 706-14·!.) submlncd by Lidoch<m Inc. 

• • Milutin S. Djwickc,ic. M.S .• Dioloa:ISI 

Microblnl Patltidcs Brunch. Dlopcsdtidcss,~U~;;::::;;;-;;:;... 

lobn 

l'ollutlon 

1- Koul;h. 

rtt\'c,uion 

Plt.D. 

Oi\'ision l7SIIC) ' ~ 

Senior Scicuisl~~ • Ml<robi>l PCSIItidcs Bn~nc , Blopc.stlc a 

l'ollutlon Pn."'-cntlon Di,ision (7SIIC) 

Mi<h><l M...S.!John, R<aubtO!)' 1\aion l.c:ld« 

Ml<mbilll Pesticides OlllllCh, Oiopcstl<idcs ond 

Pollulion Pm'Cntion Divwon (7SIICJ 

SE£ CONFIDFA,'TIAl. BUSINESS INFORMATION APPENDIX 

ACTION R£QUF..sTED: To ~'<'icw dtc S Bolch Enumcroticn. Product Chcmistty, Monufilctwins Pro«ss. St0r:1~ St4bility. ~k Disposition. ou.:u..ioo ofform:>lion of Unintentional 

lnw~i~ts. Cmifi~lion o(limiu.. Aeulc To.-cicily StuditS, and Tolenmcc E."<crnptlon for Vam1mo 

Tcchnicoi/ST (I!PA Reg. No. 706-I~·T) submin•-d by l.ido<htm Inc •. Md p<Olidc a ri>k 0SSd$111cnl. 

CONCLUSION: ACCEPTABLE. 1\CU!r 0<111. pulrnon3r)l. ond inj«tion toxicilylpothoacnidty lei:&.ing ofVamimo Tcc-hnal b:as sho'\n lhat il is nolloxiclp;uhogcnic. ll"posure \'ia mlducs \\i1l 

<>c:cur, 

WSP 

bill litem oro no expected....,.,.,.'(! howds. The /\CUI< O.rmol Toxicity study for Vomlmo pl.1ccd the k5l subs......., in Toxicity C41ca«Y Ill for lobcllng purposes. The S\lbmiUcd \\'llll'<r 

r<qUCSI for ICU!c tO.~ I)' C11CllmJI'W<' clcrmoJ to.<kity.lnd thi&S 3lso pbca !be usc ofVomimo Tcchnicoi/ST in Toxicity Ca1cgory Ill. &sod on dtc rcsuiiJ from 1ht Acute Damol Toxicity Md 

1 
Acute Ocnn11llnit:uion tests ror VAmimo WSP in comp.vUon to, a difren:n1 04Jt('()rnc in the cknnlll 

testing ofVomimo Technical/ST would not be cxp«t<d All\\'0 onlmoflll4jlniludc ot svc:h o high 

~~...... ' 

Bocll/us Oh1)1ollqut/oclcll.< is highly P"""'l.cntln tbe •n•·iroiUTO<IIt. M1111ond onlmal<""' likely 

apos<d to~ b>dniA on rqular lwiL Then:forc. the dm pr<Knt<d in the submwion supports 

lbc US< o(Vomimo TtthnkoiiST as o biolosial S«d ~olm<ftt cnn be «>nsida<d a low risk to 

humon halth. Tbc submht<d Htmtun: suppons • tolmncc Cl<cmpdon. Oth<c """' W<h os dn:nch. 

fol~ spray. drip lrri(lJIIIon. roo< dlp, ln.'C inj«:doo. h)Woponics. ond soillncorpor.uion will M\'C 

ex~ scm:ulos. but no !word is c:xp«t<d duo to lbc lxk oftoodcity po~city. 

DATA REVIEW RECORD 

Acth'C lnsmlil.'llt: Boc/1/us am)Miqut/«ftns PTA-1838 

Product Nome: Vamimo T .. hnlai/ST 

Compony N"""': Lidochcm Inc. 

Rq:. No: 70644-T 

O.Cision Number. 49S9S2 

Submission Number. 9S&J20 

DP llotc'Odc: 424147 

MRIDs No: 49474101to4947411 1 

BACKGRQlJNp: 

Lidochcm Inc .. has submlu<d on opplkatlon to r<~ist« Vaminto l'cchnloa!IST ond otolcmncc 

exemption pc~ition con&oininG lbc oC'lh'<ln~mt Borlllu. tmr)iollq~~</o<ltns PTA-1838. 

Boclflus arn)'lol/qutfncltiiS PT1\ -IBJ8 is a ~nun poslti\'C nof1opothoa<nic bacterium \\hich ;, 

c:ommonl)• found In the air. ""tc:r, soiL and on plants. B. sub/Ills'""· unrJiollq~~<facltlas is US<d to 

produoc (l<Oic:oiytic Cl\l;)'n1CO ror Loundiy ~ts. ond ;, used in hroilcr feed os a probiotlc. 

Vomimo Technical u intcnd<d to be used ror ronnulodng biol01ical pcs1icidc products. and 

Vomlmo ST ;, • biol"'icolsr<dtrttLUn<fttoim<d., Jl'llviding Jl'llt<Ction ror...., rrom nematodes 

3lld funpl plant ~ Vamlmo ST may also ada • plant iJO"'Ih pn>rno~cr, and it ha$ wide 

ron;lna uses rot lmllina asri<Uiturol >C<d inc:ludins soybean and supbcct. 

PlliCOSSJOl!; 

Tho COrnm<M\ pRS<ftCC or 8. QM)~o//qacfocfrns in SO(IJ and agrituhural cnvinlluncnts SUJ'POfU lbc 

assumption lhat bUINIIIS on: likely ctposod to lbc b>dcrium on a n:gulot buis. Tbc use or B. 

UM)~oliqt~</atlrns PTA-4&38 as a S«dascotmcnt Is not Clq)C<I<d to inc:=se lbc ma;nitude or 

n:>iducs on o hom:>l<d crop due to a dec ..... in pn:scn« oflhc bacterium os plants arow, mot we. on~ an: hor\' .. t<d. Other""" svc:h OS drench, roliAr spray, drip lrri;ntion, root dip, tn:e injection. 

h)'Ciroponics. 3lld >Oii"-Ponllon "iU M\'0 ctpo""" scenario'- but no hWU'd is ••p«tcd due to 

lbc lock ofto•kitylpotbov<nicity. 

2 
SUMMARY OF DATA SUD~IIDF.D: 

S Datsb •:numsc;ulon end Dusst!on ofMismhle! ContomlnonJ•: (MRID No: 49-174 !01) 

The """"'<'llum=tion of Ill< t<Sl m:>l<riol """ 3 x 1011 Ct1J/p <q>e>r~od iA ubi< 1 on p>~ II of ~!RID 49-174101 ond sho\ln bc:low. 

Table I . EnumcGtjon Sumnwy 

T<S! SuMIA!!W Botch CfV/Q 5704196 

5705198 

5711201 

5714202 

5722204 

Mctm 

Sundord IX\iollon 

Reblh·e SI.Mdard IX\i3tion 

St3ndotd Em>r 

2.6x l011 

2.6x1011 

1.7x!011 

1.2'<1011 

4.8x!011 

).Ox 1011 

1.2:< 1011 

3.9 x 1011 

5.1x1011 

'[able 3 · Conl;ynjp;njon ScJml Symm;uy 1 V. cholmN AMsot in 25 lii"'M by test for oil bcl!chso 

S. OJIT"tUJ Absalt in 2S Volfi\S by ICSI for oil balshso 

E. roll AM<nt in 1 gram by test for oil botchso 

Toto! colifonns Ahlcnt in I ljlllm by t<St fur oil botchso 

Eltltrot'O«aU \~l b)• \ltf'i lication tat (or all b:lldW$ 

.<;Q/inon.tlu t\Msot in 25 ll1"J1IS by t<Sl for oil botchso 

Shlgtlla t\Msot in 25 snuns by lest for oil botches 

AR3Crobic pi:Ue- counU showed no C'Ont:unimtion (or C3Ch barth :U dilution (xtors 1 0"1 IO 10"". 

The con-lnotlon scm:ning n:sults did not fond the pn:smce of 17brio clroltrat. Staplo'iocou111 

u11m1.1. Est htrlchla coil. 10141 collfonns.'£nt<,.....,.../. Sulmon<lla or Shlll<llo in MY of the fh"C 

botches of test Sllbsun<.:. 

r!!\'SICAI. ASp CIIF,MICs\1, CIIARACTI;RISTICS: RIO II :12i7410ll 

Vrunimo Tcchnlclll ""' dct<'11111ncd by boll! ob5a"\"Crs to be: alight bro\\n color. ond Ill< Physico! 

lbte- is 3 j()lid ;at 20*C. NodctC'C't:Lbtc odor "'U ob$c:n·ed at :u•c_ Vamlmo T«hniC41 i.s 

""'~ u sub!< r..- th<dlmltion of !he tes~lng period (14 do)-s) ond S4'C 1<31ina conditionJ. 

3 
pH"-.. ......,m! 10 be 4.6 at2S"C. and IN<pG\\dcrclcnsity was calcubtcd 10 be 1.91 efmL at 

20"C. 

CL.\."-~ IFICAJIOI'I ile«ptablc 

Scorns Scol>ility •n~ CO!T!!IIon Clt•!!Sisri<tlp; (MRJD M 49-17~1~) 

Tobie I. 1\nh·c lniUcdi<ntllnoh•sls 

Obsc:n'ltion 1\cti\-e ln:&ftdimt 

Period CFUis 

MonlhO 3,4 X JO'• 

Monlh 3 3.S x ro•• 

MMih6 2.7 X 10" 

Month9 ).Ox 10" 

Month 12 3.2 X 10" 

r--WIJIJf'-41AtM 

E\'Oiu:Jtions onrom>sion ch.1....,t<ristics "~"" ck\rnnlncd a>nallmltto SIObilily sompli~ 

Throuahoutthe dunuion of this study. no ubscn'llblc clw>"' In ,the productcontoln<t' or contAinor 

coupons "..,.. obsm'cd \lith the cxc:q>tion of sliaht "'Oiaht Ou<tUlllions. lloth contolncr and coupon 

samples mointoinc<l pll)-.ic:ol descriptions c:quh'Oiml to bosdin< obsm-ations. In conclusion, the 

cest su~ Vomimo Tcchni..U. \1-.s d<termincd to be stobl< sl>ol'>ing no signs of contoin<r 

corrosion after 12 MonthsofSiorugc ot 20"C.(.a•q. 

PsDskndp: 'll'lcN Is citMI' a dilution cnor from mon1hs 6to 9 and 9 to 12 in thr: octh-e ingrcdimt 

an.:llysi• or the qistrMl h.1s mode a t)~ical srror. It is not clear if the CFU/g "~"' !Kiu:Jily 

at tD11 MC! lh<ndrowc<IIO 1011 CFU/godfodilU1Ionsrroroccurm!. 

CLA.'iSIFICATION: 1\<e<plablc. H0\\'0\'Cf, itO(ip<ali th.1t ~is ather o di!U1ion em>< from 

months 6 10 9 and 910 12 in the IICiivc ingm!icntanalfsis or the rqlsuont has mode Ol)'J'OSfllpllical 

srror. hIs oot <l<>r If the CFU ~ """' octuolly at 101 and then dropped to 1011 CFU/g or If a 

dilution mor Otturm!. The rqlslr.uu Jllould d.:lrify this in<onslstcncy. This informotion doc:s not 

impact lhe risk llSS<SSIII<Il1. it is merely confirm>tOf)', because the CFU/; on: at and abo\"< the 

CFU'sls on che Iobel for usc. 

ACUTE TOXICITy SDJDIF..'i 

Acuts Onl Tos!s!!xll'!thou nkl!y In&!!: (MRJD # 49-174105) 

No mortAihy mu obsct\'cd durin; the COU1Se of the 11udy. The •pl«n.ll\-er, and mcscnt<riclympll 

nocks wc:ro: ""'"'"II putc:ms of c:lcaranco by cloy 21. bU1 h.1d not completely ch:on:-d the test 

4 
subslonc<. Th<lunss. wh<n>"" .,..,.;cor 1.9 • lo' C~"U G wos rm>nlc<t on doy 21 ln 2 of the S 

lost onimols. The oth<r three tostonlm41s .001\'011 o<ompl<te pattern of cl"""""" by day 21 ond oil 

ooimols hod compl<le el<~~~~~na: from the lunp th:lt "..., SliCriflccd on day 14. Ev<n lhoush on in<t<:U<: In the lungs \\"IISR<Onlcd onday21. 1.9 • 10' CFU/g lseonsidcmllowond consistent 

\\ilh an cn"mlll pouem ofd..,.nee. AdditionDIIy. sinee the prescnee ""'only lmlnled in 2 of the S 

lost onlmals the dolll is con.<ldeml hlahly \Wble, ond nato eonsisteru M ~ous sompling doys. 

lndi<llllns th:lt d>< lung s;unpi<S on day 21 m;~y ""'""been con!Mnlnot<d in two of the lest oninuls. 

Complctc clananee \\US rm>lllcd in the lunp for the A cut< pulmonary to:tlcll)fpothof('nlclt)•-rot 

study, "i>i<h funher conlinn.s o pottem of clt:lli1Ul«. 1.1\•cr somplts were not homoseni1.ed ond 

ploted for the doy 21 $1Crlfices, hcn\\O>"cr o pollcrn Of cl""""""' \\US Obscn"Cd in lhisstudy ond ""' 

.WO rm>nk\1 in the A(lJlt pulmonary tcuiclf)fpolbogtnlcll)'-rat on.! the Ami< Injttllan 

IOXiclt)ipntltOI(tlliC//)' studies. VomimolP Tc<hnicoJ, WDS dctcnnined 10 he not infc<lh'C ond non• 

toxic to"'" when odministm:d hy om1 ~\'DL'C in i sinjlle dose of 3.5 x 101 CFU/roL 

DrOclc-nda: None:. 

CI,ASSIFICATION; 1\=r>lllblc 

Aceto Pulmonary Toxlcl!yiP•!h.,.,•nld!y Stud\• jn Reb; (MRil) #49-174106) 

• 

micro 

This study ".., concluded to n 'OIU>Oe the pulmonoty toxicity. in(«thily on.! polho&tnlc:ily or • 

bioi pesloonlroloscn• (MPCA) ••• sinal• big)> dose._...,..,..., on.! on odcquote posi<Xp!m~R' 

obscr.-clion pcrlnd. Th= wm: no obnormol sencllll hccllh obscn'llions. Tlicrc wm: no olmon"<d 

oboorm.'llities durins nccropsy:Thc test Ofillllbm wos considcml complcl<ly <I= rrom the blood 

3nd «C\\m by O.y 7. 

1llc 

~Ism""-' 

test or~nbm w•s con<idm:d •oomplc'<ly clcor fron1 \he kidnc)'S on.! MI.N by O.y 14. Theta~· 

consideml compl<tclyclco...d from the broin.lunp. ond splccn by O.y 21. The ICSI 

The 

org.;.nism was presn11 in lhc lhn on D.1y 1.a In one oul of Ji.x animaiJ. bu1 \\lU clc:v on Day 21 . 

when 

lest substance~ Vamimo TC"C.hnlcml. was dccmnlntd to be: not infccti\'t o.nd non-toxic 10 r::us 

odminisw<d by lr.IChenl injcctlon in o sln;lc dose orl.l x 10• CfU/11 or 3.1 x IO'CF\J/roL 

OrOrirnclg: None. 

C!.ASSI ~lCATION: A~l~ 

lntDI•"•n••• Th>lslh·!Patbocsnlsil)' Study In Rot<: (MRID # 49-174107) 

No :sbnortNJitift \\'en: seen during <bily obsC'n-aliotl$ or :u ecropsy.~ Wt\J no monalil)' in any 

£noup during the study. 1llc lest OI"Sonism hod cl<ored complctcl)· from the tosl substonec group 

blood by ll:>y 3 ond from the broin ond the «CUm hy Doy 7. The lest ~bm sho\\"<d • pollem of 

cl<onnoc from the lunss.ll'"'· spa-. ond m<Kt~teric lymph nodes. On do)• 21 there.,..,., 

incrcosc IO .. ··-scor 1.3 X ~ CPU/g IO rrom 01<100 f~m d•)" 14 in !he lungs, which \\">S 

CFU

caused by only 2 or the 6t<Sionimols. E\"Cn ohoush "" Inc ..... in the lunp was recorded, 1.3 X lo' 

I11is considcmllow on.! eonsistcnt with on o•'Cillll pottcm orcl<:>r:lntt. ,\dditionolly. since lh< 

5 
pr<scn<c ,.,,. only recorded in 2 of lbe 61$ animals the d410 is considatd hl~h\y varioblc, ond 001 

o consistC11tos .,mious Sllllplina days. lndialiaa lllot 1be luna ..,.pies on d4i21 moy b:l,, b<cn 

con1:uni112tcd in two of the .lcst.animW... Compl<to ol"""""" wos r«<rded in lbe !unas for the 

A<lllt pu/•101101)' toxlcil)llpaJIIOIIf•olclty-rot 111udy. "ltich furlhct connnns • pol tern of clean111Cc. 

The: I$""""""" Vomimo~ToeMieol ""'dclormincd 10 be no1 infmh't'ond non-toxic to rolS 

when in)<etcd introvcnowly Olo dooc of2.7x 10' CFU/ml or 2.7x 10' CPU per rot. 

Psflricndg: None. 

C!.AS.'>If!CAT!QX: t:e<p~~blc 

AcutcT nlsoJocr Walvrr Rrnuat: (MRll> ~ 49474101) 

;\cute oral. pulmonary. and injrcdon 1oxicity pc1~ci1y tc:stinc o(Vamimo TcduUcaJ h.u aho\\n 

IMI it is ootlo.,ic/p:nhngcnic. No C)'£ irrilation was rcpo11£d for V11111imo WSP. so no<)'<' irril.tlion 

would be aprclcd for Vamimo T«hnieaiiST. The: \\lli\'<r r<qucsts for lhe addili0112l n:quin:mmiS 

includina: A<Uic orol. dcrmol. inh>lotion. ond ">" itri~.ttion...., ,..Jid 1><eausc the srud!cs b:l'" b<cn 

performed 1\ilh Varnimo WSP, ond the Sludics M\'C shown 1he.1<111 subsiOncc lobe non·loxic. . . , ) . . ' . . ' 

IIO\\'t'\'<t',lhe Aculc Dcnnol Tmc!Coly srudy for Vomimo WSP pllccd lhe lest subsbnce rn TO>dcll)' 

Cotcaol')' Ill for lobelins purposes. The: ",J,..,. roqucst lhus olso p!occsthe usc ofVornimo 

T<chni<ll/ST, in Toxicily C~ry Ill. !loscd on the rcsullS from lhe 1\culc O<rmol Toxicily ond 

Acute Dmnallnilotionleols '(or Vomimo WSP, 'a dill'cmol OUI<OmC in the dermAl !<$tina of 

Vomimo T<ehnico!JST woold no1 be expected. The: incn inarcdicnlS in Vornimo TcchnicoiiST arc 

not &Oxic. 

nrnrifndp: None:. 

CONCLUSION: ACCEPT ABLF~ Acule ...i. puln>OIW)', and in)«:lion toxicil)'ipolhogenleh>· 

lcsting ofVomimo Technical hos shn-.'" lhol his no11o:<icl~lc. E:<posun: ,;. residua "ill 

occur. bullbere on: no ""P""cd o.ssociatcd bawds. The Acute Dennol Toxlchy 111udy for Varnlmo 

WSP pi>Ccd the lest IUilsun<c in To.<ici1y ~ Ill ror !obclin; purposes. The: submitted"..;''" 

request for ocu1o 10xicil)' onccmposscs d<rmolloxkhy. ond lhus also ptoccs lhe use ofVomimo' 

Tcchnicoi/ST in Toxieily Calcaory Ill. BIISCd on lhe n:suliS from lhc Aculel>crmat Toxi<hy ond 

A<Uie Dcnnollrril>ticn ICSU for Vomi""' \VSP in eomporlson to, o clill'<rml outcomc in the dcrmol 

lcsling ofVornlmo Tcchnleoi/ST would not be cxp«:lcd 01 ruo onlm ofrnoaniu.odr: 01 sucto o hlsh 

dosing ,., .. t. 

ll<rclllou tlm)follqu<[a<frns is hi~ly pmulcnl in I he cnviltlMl<nl. Man ond onimols orelikdr 

e<poscd IO lhcsc boclcria on 1<.'8Ulot b>sl.c. Then:fo .... lhe d410 pra<niOd in lhe submission supports 

the usc: of Vorni""' Tcchnkai/ST as aloioloaiaJ seed lr=tmCIII c.'lll be considatd 1 low rlsl; lo 

hu11UU1 heohh. The: Mlbmlucd lil<r~luro suppons olotcnute:e ""ornp<ion. Other USC$ such os di'CIICh, 

6 
folior sprny, drip • 

exposuro --=los. irrigsllon, root dip, an:c inj<"<lion. h)'Olroponlcs. and soil inoorpor.uion will hove 

but no hoz:ud is exp«t<d due to lh< bdt of aoxiday/pot~icity. 

Fsd('n~l food. Dn~g. and Cmmsrfs Act tFFDCt\l Comld~n~tfont fgr 

Rtqant (or an Ext:mpllon fro•th~ Rcqalrrrnmb of• Tolcnzatt for BIICI/Ius 

#MJiollqll

DPI/414147; 

•f#cltnr 

Vomlm~ 

P'J'A-4838, 

WSP 

FQPA Asscumtt>l; V•mlmo1!TtehniniiST Dccblon IU95952, 

D<dsloniU95960, DPIU24151 

c<loblish 

Stetion 408(c)(2)(A)(i) offFOCA olio\\~ the U.S. En\•ironm<nlal Ptolcction Agency (EP") lo 

rc:slduo 

on <:<emption ftom lhe rcquir<mmt for ololortUlCC (lh< l<i"lllmit for • pcrdcidc chcmicol 

~0 (c)(2)(

in orono food) only iflh< EPA clctcm~incs lhallh< <l<cmption is "sofc." Stetlon 

A)(ii) ofFFOCA den~ "l~Dfc"lo mcon thor "lhcn: ISA r=noblcccnolnay will n:sull 

!hot no horm from oggn:gsl< expo..,.. to the pcrtlcidc chcmicol residue.lncluc!lng oil onlicipolcd 

di<IM)' exposures and all olllcT <XJ>OSUI'C'S for "ilicb lh<r< is n:lioblc informotion." Thisladud<S 

cs

«

posuro

posur< through drinking wolcr and In r<Sidcntial S<lllngs but does not include occupolionol 

exempt

. l'utswlnt to FFDC,\ S«tlon ~08(c)(2)(B), in cstoblislling or moinrainlng in err«! an 

ion from the rcqui,..,<nl ofotolcroacc. 

In FFDC,\ 

the EPA must ral:c into oa:ount lh< (oc1o11 ""'forth 

section 408(b)(.!J(C). 

infonts and chi

\\iti<h require the El'A to give sp«lalconsldrnllion 10 c.•posu"' of 

ld= to the pcrdcidc chcmial residue: in cstoblishing ololcr.m<e or tolerance 

c

c:<c:mpl

hild= 

ion. 

from 

and 10 .. cnsu~ th:lllhrn: is a rcason:tbfc c~:rtaln1y th:u no lwm , .. ill ruull to inro.nLJ and 

•¥G"'a"l< c.•posun: lo lh< pesticide clwrnla\1 rcslduo ••• ," Addhioaolly, ft'OCA 

cumul:nh 

scclion 401(1>)(2)(0) rcqui"" thot lh< EPA consider -.,..;loblo lnformotion collCmlln~ the 

.. err«ts of(• porticulor pcrlieide's) •.. r<Sidii<S and olh<r subisranccslhollu, 

common mcclwlt .. a 

Sm oftoxi<iiY ... 

resi

The 

du

EPA pcrfonns u number of an.:~:ly~C:J 10 dctermi~ I he risk1 from owc:g.aJe cxposu~ to paticidc 

~poos:&n: 

es. Firsr. the EPA d<1crmlnes lh< toxicity oflh< pesticide. Sc<ond.lh< EPA curnir>cs 

pcsticidolO the- pe::sticick throu~ food. drinlcin; w:.tcr. And othu cxpos"n:s thot occur O.J a result or in "'sldcr.liol S<ttings. 

/, Summ•ry of Pnltkm""for T#l<nm« E%<mpllon 

behalf 

The petitioner 

o(Lidochcm. 

Reg \Vest Compony, UC 8203 West lei' St.. Suite A. G~cy. CO !0634-4696 on 

408(d)(J), 

lnc. lO Vilbgc Cour1 Hazl<1. NJ OnJO pmposin» pursuant to FFDCA section 

21 U.S.C. 346>(d)(J) 

<mf)~ollqr~</<K

iJ rcqucslin~ on exemption ftom a ~l<mnce (or Bot:lllus 

<ns PT A-483! in or on all food commodities. 

aancuJaunl 

Uu<illw umylo/iqrt</otl<ns PTA48381s ubiquiloiiS in lh< cnvitonmcn~ especially in soils ond 

occurring microbe 

cn'i ronmcr.ts. ;\so n:sult, dicta:)' <Xposur< to hoc~ around lc\'c!J of the 11111ur:rlly 

ubiqultous presence 

I'M)' alrc:MI)' be O«urring 3nd ''ill lll:cl)' conllnue to D«'Ut. D«au.sc ofils 

in 1bc erwltortmttnl. no incn::::t.K in C'X'pOSUI'e to &Killus aruyloflqwfodms 

~~po$un: 

PTA4ll8. mullin~ from lh< rropo«d pestidd.ll ....._is cspcclcd •men compom! to cxblins 

to OOd:;round Jc,'<'ls of /Jocll/11$ tlltf)'lo/iqwfiNIMs IYf"A--4838. l.o ilt~tions wbm:: 

7 
. oppliClltioN on: closeT to h>n"<SI tlmcs. rcsic!ucs on cmps ""'cxp«<<d to be: hiGh« lh>n nonnot 

b:lekground "'''cls. Ho"'C!\'CI', tho product Is nottoxiclpotbogcnic ond ;. not C1Cpcctcd 10 QUfC 

""'..,.. ~>Wth .rrccu. 

8o<IIIU1 Dltl)~ollqW<juclms I'T A-1838 has b«n dcsc:rlbcd u irreautor, ,bc:i,e. crot<rifonn \\ith 

undulote mor;jRS. lkKillllS _,toJ/qlll!/«l<ns I'TA-48)8..., grom-J>Ojiti\'e rods " ith porltricbous 

fbacllo allowing motility. The cells olkn appear ulon~ <h;>ins unlike many Olh<r Bo<ill~a species 

thot form u sin;tc celts. The <Jilllmol ocmpcraturc fot ecltular SI0"1h is bc:tl''e<n 30-40'C. Slmlltu' to 

other Bocil/ou spccl<>. Boc/1/us am)tol/qwfa<itns PT A-4838 fonns enclospola alto"ins """i'-:d for 

• tons ptriod of time. EndOSJ>ONS •PI'<W ecntrially In the eel~ which do not hA,, o swollm 

._. The cultun:;. deposited in the American Type Cult""' Collection's (ATCC) P•tcnt 

Collecllon and idmtlficd as •New stroin of BociUus. APM·l (ATCC PTA 4838). Bocl/lus 

aJif){ollqwfockns .uain PTA-4838 ,..,.. W<onomiwly id<ntlr.cd uslna MircoSeq tcchnololl)' by 

Ml<nxcst I.Aboftlorics shc>l'i"8 a 99.69% motoh to the ATCC deposited cult=. 

Boc/1/ou atn)follqwfotlcn.< I'TA-4838 b noi consld«cd to be: a humon pothoacn. &c/1/IJJ sull/1/u 

spod<>. in<ludins &<IIIIlS GM)'Io/lqw/t>rltiU PT A-4831 (&<11/ou aJif}fo/lqutfo<i<JU wu 

pn:,.iou.ly classiflcd u &<//Ius s~tblllls ,..,, am)tolh{u<focl<n>), prcdua: pro1<01)1ic m:cymcs and 

..., \\idcly us<d os oddithuln laundoy dct~ts. &<11/ou am)follqutfa<l<tlll ;. also used in 

broiler feed os o probiotic supplcmcnL 

1/, Ta.cla>IDfletrl Pntjllc 

Conilitc:nt "ilh FFDCA section 408(bX2KD). lhc EPA "'''ia''Od the o\'ollable sacntlfic dolto and 

olhcr n:lcwnt infoml3tion on Bac/1/oa -,tol/qwfocltM PTA-IllS, ond consldacd its ''llidity. 

complcoa>ess, ond rcliobilhy. os wcllu tho relationship ofthb lnformotion to hunt~~~ risk. The EPA 

also coruidacd a\'llioblc infonn:atlonconocmina the variability of tho scnsith·itics of major 

idc:ntifiobtc subin>upo of <OIIRim<n. includins lnfonts ond children. 

A. O...rricw of 11«1/lllS aJif}toll~ll<fackns 1'T A-4838 

&<//Ius aJif}iollqwjrKkM PTA-IllS is an aerobic. •I"""" forming. gr:un posllh·o motile rod, 

ori&ln:olly isot:ucd room groin rtour. ond is commonly r....s ill thoen\i ronm<nt. " ;.known to be 

funslcldol. os • ncrnotode suppn:ssont. ond moy oc\os • plant gro\\lh rcaulolor. 8. 

ultl}tt>llq~~<fo<i<IU PT A-1838 is ellllinosc. proteose. one! llposc prcduc.ina soil b:let<rium. Howe•·cr, 

'"""'"'h to dot< hAs no< spodficd tho Cl<liCl mode of action. &<//Ius Oltl}iallqwfaclttU PTA-4838 is 

sold as VarnlmoX> Tcchnleal whlch Is intcndod to be: used for fonnulltlns biologit~~l pcsticido 

prodUCts. ond VomimoX> ST is • biolnai<GI SC<d uatment aimed ot pn>\idlng protection fa< seeds 

from nematodes and funsol pl31\t !"thoa<RS. Vomlrn<>X> ST may also oct u o plant~~~""'" 

promoter. and itlw "ide =sins uses for tt<:otina ogricwturu SC<d includinllsoybcon and 

suSI'rbc:cL V~. W~P !• • funsjddc and n<m.11odc supprasalll thot con be:. used on all crops 

includinll omoma~tol and turfoppticotlons. Vunimotl WSP t1111 be: oppticd ntonc or in comb! notion 

";"'other funsicid<s.oncl as • plon1 8J0"1h protnotc:r ,..., apptkation tbrotr;h drippinll one! ' · 

drcnchi"8 ot bc:t\\'e<n 3·32 ouna:~in 25 ptlon.s of water pet ocn:. -

/cltnllryofth< fJ<JIIclck and "'""pondlltiJITikh- The pcs~ cidc and corn:sponding n:siduos at< 

8 
ld<1Ui0cd oslhtdllus amJ{olfqii<]U<ItltS PTA-48)8. The octh·c ingmllcnt""' Included as end 

Vam

rroduc• mo~To<hnioal

<=i<r on 1M end 1M pmdU<t Varni- WSP ond os • manufxwrins or seed ln:llmmt for . 

umyloii<JII<:focltltS 

;\(QRnltudr ofrrsllhN ot tl~ tlnk" o/ltor~~SI utKI mttllud ustd 10 dtttrmit~ tire rt.sitlu~. IJ«Iflus 

Is ublqulcous Inch< en\iron.,.,L npccially in soils ond t¢culunl 

nolurolly-o<rurr!ns 

cn'in>nrncnts •II O\'« 

mic

th< wond. As • ,...,.IL dlowy <XJ10SUtC 10 bockground 1<\-rls ofth< 

h< ccmporory 

.roh< moy oii\"Ody be oo<urring ond "ill likely concinuc 10 oo<ur. The"' moy 

pesticide:

lnct'COSC$ In 1M pof>tlbllon of B«llllll Qllt)follqwft>dtns PT A-4838 dllc to its UJC as a 

Any polcntiolly . Howc\tt, 

O«urrins 

this IC\-.I Is apeclod co dc:c,....lo boclcsround IC\-.:Is !IOOiloftcr opplicollon. 

no 

rcsidwl dc:posics on croP, \\ill'no< homt hwruutS bc:coiM the stntin obows 

toxicity. infcrthi\y or p:11.tqmkit)•ln a~tc 1rsu. 

f;vplunotlon of why an uno/)1/ml•ttthtJJ 

rtsldutt 

for tktt<llng and mtamring tht! f<>'f!ls oftht! patlrltk 

show 

ttre not nuasary. The acute toxicity stWies diKUSSIC'd in this doc:umcnl ~ sufficiC'nl 10 

<h< produe1os 

tho< then: on: no fon:s..oble human or domC..ie heohlt l=.onls likely co llri.sc rrom 1M usc of 

ptoposed. UdoChem Inc.. ls ~<qOC1tina an <><emption ftom!M tcquin:motl foro 

n:sidue 

tolerance 

lev<ls 

for ony n:siducs n:molninll in 0< on ollo!lrieullurol commodities. Since cnfon:cmcnl of \\1luld nol be needed. on cnfon:cmenc onol)'licol method Is nol tcquin:d. 

B. ,11/crobia/ Pestirlde TOJtiCOIOfO' DQ/o Rtqulr<nttni'S 

from 

All"''!'l

1M 

icoblc mornmolion toxicology clato tcquimnencs supporting th< tcqiiCSI for on oxcmp<ion 

nil food commodities 

requlrc:mmt of o tolcroncc for residues of /k~r/1/us anr)10llqtit]tKitiJJ PT A-48)8 in or on 

supportin

Jto,.., bc:cn fulfilled ,.,;Ill cto... submintd by 1M pc<ition<r or ro.llon3Jcs ond 

;: intol"nUiion 10 :tddn:ss SP«ir.c cxposun: a.nd hmlrd sccn:uios. 

primoty 

Tbc IOXIcicy 

dc:mullrritollon) 

t<:SIJ (liC\liC or.JJ, dermal, ond inNJotion IOJ(icily) ond iniiOiion I<:SIJ (oc:ul< eye ond 

clossiflcd 

that lllldteu potcnllol routes of opomn: to lh< ocd'" ingmlicnl on: oil 

&cillus am;

in Toxlci1y Co«;ory Ill or IV ond rc\-.:olliulc 10 no coxiclty or lrritotlon ouributcd co 

mien>bial pestic

follqwf«I<N PTA-4831. Mon:o,u, duri"':DI)'Pieol dcrmal<oxlcicy 1cs1 dono \\ith 

ides, lla<ll/us um)follqt~tjocltns PTA-48)8 showed mlnlllllll slsns of drnnol 

irritotion. Finolly,IM p:titioncr rqiortcd that, lo dOle. no hypcrscnslti,ity 

durins =h. illciclcncs M\'C O«urn:d 

dC\-.lopmcn~ ond 101ins of !his boctcrium. 

' 

The concl.Wonslebosifieolions 

brieRy dcscn'hcd 

from allto.ori<closial infonnollon submint<l by 1M pctilion<r on: 

below. 

Vprnfmo Tubnic-111 

"'""oral 

monol

to.<lcltJ{pot/KJgtni<lly (1/mntonl:ttl Gulthllnt /JlJJ.JOSO: MRID No. ~9l7~/0S). No 

nodcs wcA> 

ity W:tf obsen-.d durinj: 1M coutJC: oflhc study. Thc splccn.lh·cr. ond mncntcric l)mph 

subSion<c sho\\ins poll em'S of cltiU1U1«: by doy 21. but hod not completely cl<11n:d lh< .«>' . The lungs. whore on O\'<rllj;C of 1.9 < 10' CFU/g W:tf n:col\lcd on clay 21 in 2 of!M S 
lest onimals. The other thr<e test IIIli miis show<d. complm poll em or cleot>n<C b)· cloy 21 ood oll 

:mim.ls hod completcclc:uunc:o rrom the lunp thlt wac socriflc<d on d•y 1':!. E\'<fl though an 

iocrc.ue in the lunp \\'OS m:onl<d on cloy 21, 1.9 x 10' CF\1/g is considcmllow :md consistont 

"ith on "'"roll pottom or clcolooo:. Mditiomlly, si""" 111< PfC$<I'o<C \\liS only m:onlcd in 2 orll1c S 

tC>t onim.ls the dolo is consida<d hiahJy ''lri>ble. and not • consi5tcot a pm•ious """plinll do).., 

Indicating that the lung Amplcs 00 cloy 2,1 may !]a•• ~ contaminolcd iD two orll1c test llllimols. 

Complete clcanu><c ""' rocomcd in the IWIJ;S ror the Ac"'t pulntonaty tct%/cil)fpathoxtnlclty-rot 

study. which 1\utltcr confonns. pottcm or.~. u, ... sompks ...... ,.. homogmlud ond 

plat<d rortho do)' 21 sacrifices. ho ....... ,. pollcm or ciW...:e \\115 obsci\'Od in this study and ..... 

abo m:ocdcd in the ACIIIt pu/_,' t01f:ldl}(plllhogtnlril)•- rtJI :md ll1c At'Ulelnjc<tlon 

taxlc/l)fpat/HJx<nlc/1)• Sludics. Vaml!Ml!> Technical. was dctmnin<d to ltc not iruc:cti\'< :md non· 

toxic to l1llS \\hen lldminlsteicd by oro! aavoie in a slnlile dose orJ.S x I 0' CF\1/rt>t, 

Acwc pu/mottar)•toric/1)1pothog<n!clly-roJ (1/0I'nHJni:cJ Gu/Jc/lnc 88J.JIJO: MRID No. 

~9n~J06). This study ..... cooductc<lto ewlt.atc tltc f'Ul""""">' to.•irity, inr..U,ity ond 

pothogaticlty or • m!cmbilll J1C11 control agent (MPCi\J at • sinal< high dose cxpoourc and on 

ad<qu:>t< po$1-cx-~~ ptriod. ~-'=no obr1onn>l sencrn1 health obscl\•otions. 

Then: "'<"' no obsm'Od obnormolitics durina necropsy. The ,test org;Wsm was consida<d 

completely clear rrom tltc blood ond cecum by O.y 7. The ~cst otpnisrn was considcn:d 

completely clc:or rrom the kidneys ond MLN Mc::sentcric L)lllpb !.:odes b)•lhy 14. The I<SI 

o~lsm \\liS considcn:d completely clcu<d rrom 111c brnin. luniJS, and Jjllccn by O.y 21. The test 

Ofllllllism "liS p«S<ftt in the li,-.ron lhy 14 inOn.:outorslx animols. bul wascl=on lhy 21. 

Tho test subsl:ln«. VAmimo~ Technical. \\'\\5 dc1ennincd lobe not infect h-e And non·toxit to mlJ 

"hen :ocfmlniJiard b)• uad>c::ll lnjcctlon in ulna!< dose oO.I x 10• CFU/s or 3.1 x IO'CFU/raL 

A<lll< lnjcC'IIon toxl<lt)'lpot/togrnlclty (1/ormoni:rJ Guidtllne 88H100: MRID No. ~9~U/07). No 

abnonna1i1ks m:re SIC'm durin; daily obsm'lliORS Of 11 nm'OPS)'. 11xtt was no mOrtality in ZUJY 

sroupdurifli the Sludy. The ICSI ~m hodcloan:d.completcly rrom I he lest substoncc SMIIJ> 

blood by Day 3 :md from the br.Wt Oat! the CCCWII by Day 7. Tho lest organism sho\\<d a pollcm or 

clearance rrom the lunas,II\'Cf, spl<en, ond ~lcric lympb nodes. 0n cloy 21 there \\'OS 1ft 

~to"" »-...gc:or I) x lol CFU/s 10 rrom 0/<1/JO rrom claY !4 in the lu~as. which""' 

caused by only2 or the 6 .... onlmols. E\'<ft lhoughan ~ i.n the lungs"" rccordcd. 1.3 X 10' 

CFU/; is considered low arid cOnsistent "1111 on o,•Cn.JI pottom or cl......,... Addition•lly, s!ncclhe 

pmcncc "" only n:conlcd in 2 ortltc 6 test oniaWs thc dou is consida<d hiahly \wiable. ond 1101 

• consilient as prc,·ious $11111pllna cloys. lndlcotina lhll thc lung Amplcs on cloy 21 moy h;m: been 

conlln\in;ltod in l\\'0 o( lhe I<SIIIIIimols. Complete cl..,.,.. "" rocomrd in the lunas ror the 

Acwt pulmonary toxlcll)fpath08<nlclty - ·rtll study, which llmher confirms a pottan or clQI'AIICC. 

The tcs1 su-Vamlmo¥1 Technical,.,.. dctcnninrd to ltc not lnrcclh'< and non-1oxic to I'II1S 

when injcclcd inlr.m:nowly aiO dooc oC2.7 x 10' CFUhnt.or 2.7 x 101 CPU pa !"L 

Acute Toxlco/OfO• Wan'" Rrqwst. (/lormonl:eJGuiJtllnr 1170. 1100. 1100. /JOO. UOO, l$00; 

.IIRID No. ~9~7~/08). Aaitc oral, pulmonory, ond lnjc:cllon IOXlcit)1pol'-"lcity lcstina or 

Vomimo Tcchniclll has >ltcrun tho! it Is r.ot toxlclpolhog..Uc. No <)'C lrri~ation "" n:poncd for 

Vamimo WSP, so no C)'< irri~allon "'OUld ltc cxp<Cial r ... Vomimo TcchnicaiiST. Th< woi,..,. 

r<qllcstS rortbt odditionill itquimncn\S including; A'cute oral, dCtmal. inholotion. :md C)'C inillllion 

10 
the 

""'volid 

lest subslontt 

b<cousc the sludi<J "'"" bocn pcrfonncd "itb Vomimo WSP, and the studies""'""""'" 

· pl><cd tho I<SI S<lb>loncc 

10 be non-toxic. ll""'<'n, the Acu"' Ocnnol Toxicicy study for Vomimo WSP 

obo pl>ecs 

in Toxi<ily Cotcaory Ill for lob<lina pUIJIO'CS. The woh'C1' I'C<IUC1tlhus the usc ofVomlmo T«hnicoliST the ;\cut~ Dcnntll ToKiciay 

in Toxicity COiqje>ry Ill. 8:>sa! on the I'<SUits from And Acute !.>cnmllrriur1ion 

in 111< dcnnoii<Siinll ofV~~t~~lmo 

IC:SU for Varntmo \VSP. o diO'crcnt oUl~ 

Tcchnico!IST would 1101 be: .,.,pc<,cd. 

Iff. A/lf:"K'flt &ptu<t,. 

In """"'ining •~< expos=. Fl'DCA SC<tion ~08 dirtets 111< EPA co. consider ovoibblc 

C'J<posu<a. 

inform111ion conccmins cxposun:s from the p<>ticidc <diduc in food and oil other non«cup:uionol 

p<S~icidc 

includin; <lrinking w>Ocr from Ground \I;UCT or surfocc WDICT and ""J'JS'Sft' thtoueh 

usc In canJcns. IA\\11$, or buildlnas (""'ldcnlialond ooh<T indoor uses). 

Foo<l Eiq>nmrr: floc/1/us ant}o/ollqu<[«ltns 

•ll'iculluml cnvimnn><nts. As 

;. ubiquitous in the cn•ironmcnl, cspcci•lly in $Oils and 

occurring microbe m>)' 

• n:sul~ dlcwy C'J<posut< 10 boCkground lcnb of the nolumlly 

times. rmdu<J on crops 

alrc:ldy be: occurring. In situotions \lilcte opplic:otions ""'closer to """"" 

amJto/lqu<[odt~u 

oro ""peeled IO be: hishor lhon normal bod<ground IC\1:1$. Ooc/1/us 

lhc product contoinlng 

wos 

8«11/us 

prc•iously 

OIIIJo/o/lqwforltns 

cbssifocd os &<Ill us subtllls '""· ant]oioliq~wfa<IMS. Ho\I'C\'CT, is nolloxiclp;othOgcnio 

cowc odvcnc h<ollh 

and is not cxpcc1cd 10 

cO'CC1s. Simi111t Bu<lllus suhlllis Slrains..,.. used lnlcm>liomlly production of in the 

sp. orcl:no"111o 

food llfOdc p<Oducu and in fmncnocd foods in Jap;on and Thoilond. floc/flus su/nilis 

llctw""n 1990-1996 

<liUSC spoilogc in doueh. and lltC =I)' found 10 cousc food poisoning (Ref. 1). 

outb<caks. Olhcr 

len diO'Cf<nt foods""'" bc:cn IJSl!OCimd \\ilh B.sulnilis foodhomc: illness 

h«n IIS$0C'i:ated wilh 

infi'C<lucnl 

Boc/1/u.r 

c:ucs hA•·c bc:cn rrpo~cd os well (Ref. 2), buc no r<poi1Cd illnc;scs hA\'c um;~nllqt;Qf~eltns PTA-4838. 

bos<d 

The pn:SC11C< 

on the ll>l<ici

of /Juc/1/u.r 

ly/p<>lbo!.'rnicily 

amJ1o/lqut[aclt111 PTA-4SJS residue on crops poses little 10 no~ 

rei>Ocd <'Xposurc 10 &1<11/uJ 

<IUdics. The rUI: posed 10 odults, infunts end children from food iml)o/ollq~~<[a<lrns l'l'A-IS381s minimal due lo the dcmonslnllcd 

Of XUI< omlloxichy

lock 

/pothogcni<ily !WiOtblcd -.ilh the miaobbl pesticide. 

Dria•ftw fYglfr E.vwurr: (ikldl/111 amyfollqutf(J(itns 

c>pos= 10 

is ubiquitous in the awironmc:~u. nnd 

intended usc 

the 

of 

microbe: is lik<lyoccurrins •1 bocqround lc\'Cb in the <lrinkin; w•tcr. The 

for pfonl discDSO 

flocl/lo« OIIIJ{o/lqut[acltns PT A-4838 l<e:ltmcnl on gro\\ing crops or ~ I/C41mcnl 

;round WilletS. &1(//lus 

<0111101 rnoy «$Ullin lhc polcnliul for drift or runoiYwhicb could rt;>(h surf4CC or 

bactcri:a Mel ore not 

aMJiollqwfa<itns o.nd 8«11/us n•blllls sp. ore not .,.oanizcd oqu>olc 

P"'<"SS<S 

e~ r«l«i to grow in aqwtic; cnviroMlCnts. Munic:lp.1l drinking wotcr ""tnwnt 

and doq> "~'"" \\'Cils reduce pocmtiol raiducs. E\'<ft ifomle:<_.,lo microbe: shoultJ 

lllis ubiquilous 

lnjccdon 

oteur th~ah drinking w31eT, d~ to itJ ckmonstnucd Jack o(DCUtc: oral, pulmoruary, 

loxi<ily/p;olhogcnicily, II' is likely thot no honn \\ill rcsuh from sud! expos.,.,,) 

11 
(}(hrr ltp!HI«<!lJq!(Qnol Elposurc: The pcsti<Uie """ of Bo<i/1"' Glft)fDltqwf«lrns PT A-4838 

cx«pt durin~ oppllcalion riahl befoo: hon'<1t. .. P"''"""''· dccs no1 lncn:osc in • si~ificanl woy 

II>< polentiol for non.<Jlcw)•, non«'<Vppiio...S exposure 10 ils restd .... for II>< &CDCnll pop~~l01ion. 

including infaniS and children, becousc Bo</1/u:r Glft)follq•~<foclrtU u ubiquiUMG in II>< cm-ironmatl 

ond becousc pop~~lo1ion ho,·e been pmiously exposed 10 bockiJfOund IC\•cls oflhc microbe. !Iuman 

cxpo>uo: 10 Bocillus SIHN/Iu in food iJ'ICI< products or fcrmcn!Cd foods ho'"""' resuhc:d in any ~qX>ns of infection. A few rorc exceptions Include reports lho1 B. sub/flu hos co used ''«)' 

infr<qUCOl foodbomo illness <4S<S. Any oddilion:alcxposur< lollodl/us a•l)·lollqwfarl<ns PTA· 

4838 rcsuttina from residues fnom pes~icidol ""'and rcsidcnriol homco'"'a- applialions "ill not 

raullln oddllion:U aurq;alcnon a«upotloMl riolc. sl""'no.aculc oral, pulmonary, and injc:\.'1ion 

IO:<icilylpathoacnicit)' h:lmtd exists. 

V. un~ulath ~ Erftcts Croat. Sabstantc~ 1dllla Common M«banbm ofTostci~· 

Section 408(b)(2XDXvl ofFFDCA r<qulrcs that, when considering wh<th<r to cmbllsh, 

modify, or n:\'OI:C eloi<r.lnoc.lho A~· considcs -.w.Uoblc lnfonno!lon" <Onc:anin~ the 

cumul01h-e crTCCIS oro porti<ularpcsticidc's resldlld and •OIIJcr substlln«s thot ho'" • common 

mccbonlsm of toxicity." 

Two olhor II. am ~ollqU<far rns sualns FZB24 and 0747 b>s<d products on lhe owl<C1 ore: 

kno\\TI to control funll"l diSCII5CS as OIJfO\\th cnluuxcr or di~ suppres:ror through an CftZ)mc 

lhot is JIIOducc:d. II. om)'lol/'fl'tf«kru PT A-48}11s dtillowo, proi<:ISC, and II pose produeing soil 

boclcrium. llo\\'C\'er, rcscarch 10 dOle hox 1101 spc<:ific:d lhc ClO>CI mode ofoction forony oflhdc 

' . lhrcc strains. EPA hox notlhorcforo found 11. amJ1ollqurftJCI<ns strain I'TA-4838 to share o 

colllmO<\ m«honlsm ofto>l<ily " ith ony Olhcr "'boaanca. slocc it is not toxic vio tho c>c>l. dcnnol. 

or inhala.dOn routes o(exJ'INiun:. For the- purposes of this toltnnCc oction.lhm:(ore. EP1\ lw 

:.ssumc:d lh>l B>cillus 3myloliqucfaclcns strain PTA-1838 docs not ho'" • common mechanism or 

toxicity \\ilh other subsu.ncu. For infonn31[on qatding EPA ·s efforts co dctnmine "i\idl 

chemicals ho\'c • common mccbonbm ofloxicily and 10 C\'alUOie the eumul41i\•e erTccts of such 

chemicals. S« EPA's \\-.bAte ot http:lluYM' rpa.fiO\YptSI <IJeslamuJm~ 

VI. lntrrmlnollon ofS.fdy for U.S. Populatloa, r.r .. ts ond ChUdroa 

A. u.s. PopiiiO!ion 

For •II oftbo reasons discussed Pl"'iously.lhorc is rcasoctol>le «rtoin\y !hoi no horm will rcsull1o 

I he U.S. pop~~lotion, lncludins infws and dtildm~, from qsrcp~c ~ 10 rcsldllcS of B>cillus 

amylotlqucfocicns PT A-1838. This inCludes all onticipOic:d dict41)• e.•posures ond oil other 

cxposuo:s for which lhorc is rdi>blo informotioo. 

B. lnfws and Child= 

FFDCA SCC!lon 408(bX2)(C) provides !hot lhc EPA shollopply on oddhionollcnfold (lOX) """Sin 

ofsofe1y for infonlS and childt<-n in II>< auc oflhrcshold crTCCIS 1o occoun1 for prcn~~LDI and 

poslll:llolloxicily and the complctcnessoflhe da10bosc on '""icily and exposure. unlcs.s II>< El';\ 

12 
dttamincs b:u<d on n:lioblo doll! thot o difTtrent m>rgin of safety will bt safe for infants and 

A<l 

childn:n. Tiois odditionol moq;in of safely iJ commonly n:fcmd 10 as lho Food Quality Protocolon 

o difTcr<nl 

S:tf<l)" fo<lor. In OJIIIl)ina lids pnl\isiOn.lh< EPA cilh<r r<l:llns 1h< <kfaull \-.IUC or lOX or ..... 

odditionol$0fcty rxoor when r<lioblodomo•"lliloblc to tho EPA oupport tho c:hoi« ora 

difT<:m1t 

bt 

foetor. Humans. including infant$ ond c~lldn:n. M\'< llktly btcn exposed and <ontinut to 

.xpoood to llodlhu U"')foliqtt</o<ltns tlwu;h JOil and rn:sh produ«. "~it is eacnn~!l)· 

Bad/Ius 

found. with no knawn or n:poned od,..,.. efT«<S. As di.tcuSS<d oba,,.., tho EPA Ms ean<luded IMt 

unt).,ollqutfircl~"s I'TA.-1838 is not to.xic, ~1hogcnic, or infccti\-c 10 manu:n~~IJ. includina: 

infonos and <hildn:n. llcc"auoo th<r<""' no thn:shold ln,..b of eanccm to infliiiU. childn:n. and odultJ 

"t.cn Bodllw Utn)iollyU<foei<ns PTA-II)S is used o«ording to lobtl dit«tions and good 

ogri<ultlll"lll pr:><ticcs. tho EPA eon<lud<s tMt no oddiol"""l mMJJin of sofoty Is n«OS$III)' to protc<l 

infoniS and ohildn:n. 

Tho 

popuLlllon, 

EPt\ oon<lud<s thot th<n: Is • ,...,.,noble <crtointy tMI no honn "ill n:sull to the U.S. 

Utn)foliqu.fotlms 

induding inf3l\tS and childn:n. from IS~tc oposutc 10 residues of 8«11/II.J 

PTA-1118 duc to olxk of to•i<il)". Th<r<fon:, an c:xcmption from the 

on 

r<quimnent of. tol<ran« is cmbllshed for r<Siducs or fkl<lllla Unl)follqllrfo<lms PTA-18)81n or 

all food com~ltlcs when used in a<<on:lan<:< "ith lob<! din:<1i011S and good ogriculturDI 

pr.><ti=J 

13 
f1FRA CBI APPENDIX 

l4