**f.~ IO**  **BAI'!DUM** SUDJF.CT:
FROM: T II ROIJGII: TO: 'OIIITED STA TES BIIVXRONNIIIITAL P ROTII C'I'l: ON A GENCY 

### 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 Ingredi ents. Ccniflcolioo ofl.imils, Acute Toxklly Studies, and Tolmncc 

### E.'"m p

tlon for Vnmlmo Tcchnicn i (EM R<i- 

### No. 70644-L ) Vomimo ST (f:PA Rqj . No. 706-14·!.) subml ncd by Lidoch<m Inc. 

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

### Patltidcs Brunch.
**Dlopcsdtidcss, ~U**  **~;;:: ::;;;**  **-;;: ;...**  l 'ollutlon rtt\ ' c,uion Oi\ ' ision l7SIIC) ' **~** lobn 1 - Koul;h. Plt.D. Sen ior

# Scicuisl~~ • Ml<robi>l PCSIItidcs

**Bn~nc**

**,** Blopc.stlc a l'ollutlon Pn."'-cntlon Di,ision (7S I IC) 

### M i <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£ CONFIDF A

,'TIAl. B US INESS INFORMATION APPENDI X ACTION 

### R £ QU F ..sTED: To

**~'<'icw** dtc S Bolch Enumcroticn. Product Chcmistty, Monufilctwins 

### Pro«ss.

**St0r:1~** St4bi l it

y. **~k** Disposition. ou.:u..ioo ofform:>lion of Unintentional

**lnw~i~ts. Cm**  **ifi~lion** o(limiu.. Aeulc To.-cicily StuditS, and Tolenmcc E."<crnptlon for Vam1 mo Tcchnicoi/ST (I!PA Reg. No.

**706-I~·T)** s u

b

m

in•-d 

### by l.ido<htm Inc•. Md p<Olidc a 

### ri>k 0SSd$111cnl. CONCL USION: ACCE PT ABLE. 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 mldu cs \\i1l <>c:cur, bill litem oro no expected....,.,.,.'(! 

### howds. The /\CUI< O.rmol Tox icit y study for V omlmo WSP 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 T

cchnicoi/ST in Toxicity Ca1cgory Ill. &sod on dtc rcsuiiJ from 1ht Acute Damol Toxicity Md 1Acute 

### 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(Vom i mo 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< d lp, 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 REVI EW 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 MR IDs No: 49474101to49474 11 1 BA CKG RQ lJN p : Lidochcm Inc.. has submlu<d on opplkatlon to
**r<~ist«** Vaminto l 'cchnloa!IST ond otolcmncc exemption

**pc~i tion**  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 V

omlmo 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. PlliCOSSJ Ol!; Tho COrnm<M\ pRS<ftCC or8. **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 orB.

**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;n tion, root dip , tn:e injection. h)'Ciroponics. 3lld >Oii"-Ponllon "iUM\'0 ctpo""" scenario'- but no hWU'd is ••p«tcd due to lbc lock ofto•kity lpotbov<nicity . 2SUMMARY OF DATA **SUD~IIDF.D:** S Datsb •:n umsc;ulon end Dusst!on ofMismhle! ContomlnonJ•: (MRID No: 49-174 !01 ) The """"'<'llum=tion of 

### Ill< t<Sl m:>l<riol """ 

### 3 x 10 11 

### C t 1J/ p
**<q>e>r~od** iA 

### ubi< 1 

### on

**p>~** 

### II of

**~!RID** 49-174101 ond 

### sho\ln bc:low. Ta ble I . EnumcGtjon Sumnwy T<S! SuMIA!!W Botch CfV /Q 5704 196 5705198 571120 1 57 14202 5722204 Mctm Sundord IX\iollon Rebl h · e SI.Mdard IX\i3tion St3ndotd Em>r 2.6x l0 11 2.6x 10 11 1.7x!0 11 1.2'<10 11 4 .8x ! 0 11 ).Ox 1011 1.2:< 10 11 3 .9 

### x 1011 5 . 1 x10 11 '[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 (orall 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-l notlon scm:ning n:sults did not fond the pn:smce of 17brio clroltrat . 

### Staplo'iocou111 u11m1.1. Es t 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, C IIARACTI;R ISTICS :

**RIO** II :12i7410ll Vrunimo Tcchnlclll ""'dct<'11111ncd by boll! ob5a"\"Crs to be: alight bro\\n color. 

### ond Ill< Ph ysico! lbt e- is 3 j()lid ;at 20 *C. No dctC'C't:Lbtc 

### odor "'U ob$c:n·ed at 

### :u• c_ Vam l mo T«hniC41 

### i.s

**""'~** u sub!< 

# r..- th<dlmltion of!he

**tes~ ln**  **g** period ( 14 do)-s ) 

### ond S4'C 

### 1<31ina conditionJ. 3pH"-.. ......,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** Sco rns Sc ol>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 Monlh O 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'-41A t M E\'Oiu:Jtions onrom>sion ch.1....,t<ristics

**"~""** ck\rnn lncd a>nallmltto SIObilily **sompli~** Throuahoutthe dunuion ofthis 

### study. 

### no ubscn'llblc 

### clw>"' In , the prod uctcontoln<t' or contA inor coupons "..,.. obsm'cd \lith the cxc:q>tion of sliaht "'Oiaht Ou<tUlll ions. 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 s igns ofcontoin<r corrosion after 12 Mont hsofSiorugc ot 20"C . (.a•q. PsDskn dp: '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.'iSIF ICATION: 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'OSfllpllica l srror. hIs oot <l<>r Ifthe

**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)', beca use the CFU /; 

### on: at and abo\"< the CFU'sls on che I obel for usc. 

### ACUTE TOXICITy SDJDIF..'i Acuts Onl Tos !s!!xll'!thou nkl!y In&!!: (MRJD # 49-17 4105) No 

### mortAihy mu obsct\'cd durin; the COU1Se of the 

### 11ud y. The •pl«n.ll\-er, and mcscnt<riclympll nocks wc:ro: ""'"'"IIputc:ms ofc:lcaranco by cloy 21. bU1 h.1d not completely ch:on:-d the test 4subslonc<. Th<lunss. wh<n>"" .,..,.;cor 1.9 • lo'

**C~"U G**  wos rm>nlc<t on doy 21 ln 2 ofthe S lost onimols. The oth<r three toston lm41 s .001\'011 o<ompl<te pattern ofcl""""""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 ""'onlylmlnled in 2 ofthe S lost onlmals the dolll is con.<ldeml hlahly \Wble, ond nato eonsisteru M **~ous** sompling doys. lndi<llll ns th:lt d>< lung s;unpi<S on day 21

**m;~y** 

# ""'""been con!Mn l not<d in two of the lest oninuls. Complctc clananee \\US rm>lllcd in the lunp for the A cut<

### pulm o

nary to:tlcll) f

pothof('nlclt) •- rot study, "i>i<h funher conlinn.s 

### o pottem ofclt: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 I

OXiclt)i pntltOI(tlliC//)' studies. Vom im olP Tc<hnicoJ, WDS dctcnnined 10 he not infc<lh'C ond non• toxic to"'" when odmini s tm:d hy 

### om1

**~\'DL'C** in 

### i sinjlle 

## dose of

### 3.5 x 101 CFU/roL DrOclc-nda: None:. CI,A SS IFI CAT ION; 1\=r>lllblc Aceto Pulmonary Toxlcl!yiP•!h.,.,•nld!y Stud\ •jn Reb ; (MRil) #49-1 74106) • This study ".., concluded to n 'OI U>Oe the pulmonoty toxicity. in(«thily on.! 

### polho&tnlc:ily or• microbioi 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<l y <I= rrom the bl ood 3nd «C\\m b y O.y 7. 1llctest **or~nbm** w•s con<idm:d •oomplc'<ly clcor fron1 \he kidnc)'S on.! MI .N by O.y 14. **Theta~**

**· ~Ism""-'**  consideml compl<tclyclco...d from the broin.l unp. ond splccn by O.y 21. The ICSI org.;.nism was presn11 in lhc lhnon D.1y 1.a In one oul of Ji.x animaiJ. bu1 \\lU clc:von Day 21 . 

### The lest
**substance~** Vamimo 

### TC"C.hnlcml. was dccmnlntd to be: not 

### infccti\'t o.nd non-toxic 10 r::us when 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 ~lCAT**  **ION: A~l~**  lntDI•" •n••• Th>lslh·!Patbocsnlsil)' S tudy In Rot<: (MRID # 49-174107) No :sbnortNJitift \\'en: seen during <bily obsC'n-aliotl$ or :u **ecropsy.~** Wt\J no monalil)' inany £noup during the stud y. 1llclest 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** 

### lym ph 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 caused by onl y 2 or the 6t<Sionimols. E\"Cn ohoush "" Inc..... in the lunp was recorded, 1.3 X lo' CFUI11is considcmllow on.! eonsistcnt with on o•'Cilll l pottcm orcl<:>r:lntt. ,\dd itionolly. since lh< 5pr<scn<c ,.,,.only recorded in 2 oflbe 61$ animals the d410 is considatd
**hl~h\y** varioblc, ond 001 o consistC11tos .,m ious Sllllplina days. lndialiaa lllot 1be luna ..,.pies on d4i21 moy 

# b:l,, b<cn con1:uni112tcd in two ofthe.lcst . animW... Compl<to o l"""""" wos r«<rded in lbe !unas for the A<lllt pu/•101101)' toxlcil)llpaJIIOIIf•olclty- rot 111udy. "ltich furlhct connnns • pol tern ofclean111Cc. 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/ m

l or 2.7x 10' CPU per rot. Psflricndg : 

### None. C!.AS.'>If! CAT!QX: **t:e<p~~blc** Acutc T nlsoJocr Walvrr Rrnuat: (MRll>

**~** 49474101) ;\cute oral. pulmonary. and in jrc don
**1oxicity pc1~c**  **i1y** 

### 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<q ucsts f or lhe add ili0112l 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\ i lh Varn i mo WSP, ond the Sludics 

### M\'C shown 1he. 1<111 subsiOncc lobe non·loxi c. 

# . 

# . , ) 

# . . ' 

# . 

# . ' IIO\\'t'\'<t',lhe Aculc Dcnnol Tmc!Coly srudy for Vomimo WSP pllccd lhe lest subsbnce r n TO>dcll)' Cot caol')' Ill for lobelins purposes. The: 

# ",J,..,. roqucst lhus olso p!occsthe 

### usc ofVornimo T<chni<ll/ST, in T oxicily **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 !<$tin a of Vomimo T<ehnico!JST woold no1 be 

### expected. The: incn inarcdicnlS 

### in Vornimo TcchnicoiiST 

### arc not &Oxic. nrnrifndp: None: . CONCLUSION: ACCEPT

**ABL F~**  Acule 

## ...i. puln>OIW)', and in)«:lion toxicil) 'i

polhogenleh>· lcsting ofVomimo Technical hos shn-.'" lhol 

### his **no11o:<icl~lc .**  E:<posun: ,;. residua "ill 

### occur. bullbere on: 

### no ""P""cd o.ssociatcd bawds. The A cute Dennol To xlchy 111udy for Varnlmo WSP pi>Ccd the lest IUilsun<c in To.<ici1 y **~** Ill 

### ror !obclin; purposes. The: 

### submitted"..;''" request for ocu1o 10xicil)' onccmposscs d<rmolloxkhy. ond lhus also ptoccs lhe use ofVomimo' Tcchnicoi/ST in Toxiei ly Ca lcaory 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 l csling 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 oreli kdr e<poscd I O

lhcsc boclcria on1<.'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: Mlbm l ucd **lil<r~luro** suppons olotcnute:e ""ornp<ion. Other USC$ such os di'CIICh, 6• folior 

### sprny, drip irrigsllon, root dip, 

### an:c inj<"<lion. h)'Olroponl cs. and soil inoorpor.uion 

### will hove exposuro 

### --=los. but no hoz:ud is ex p«t<d due to lh< bdt of

**aoxida y/**  **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 •f#cltnr P'J'A-4838, FQPA Asscumtt>l; V•mlmo1!TtehniniiST Dccblon IU95952, DPI/414147; **Vomlm~** WSP D<dsloniU95960, DPIU24151 Stetion 408(c)(2)(A)(i) offFOCA

**oli o\\~**  the U.S . En\ • ironm<nlal Ptolcction Agency (EP") lo c<loblish on <:<emption ftom lhe rcquir<mmt for ololortUlCC (lh< l<i"lllmit for • pcrdcidc chcmicol rc:sld uo in orono food) only iflh< EPA **clctcm~incs** lhallh< <l<cmption is "sofc." Stet l on

**~0 (c)(2)(**  **A)(i i)**  ofFFOCA
**den~ "l~Dfc"lo**  mcon thor "lhcn: ISA 

### r=noblcccnolnay !hot no horm will n:sull 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 « posur< through drinking wolcr and In r<Sidcntial S<lllngs but does not include occupolionol cs posuro. l'utswlnt to FFDC,\ S«tlon

**~08(c )(2)(B),**  in cstoblislling or moinrainl ng in err«! an exempt i on from the rcqui,..,<nl ofotolcroacc. the EPA must ral:c into oa:ount lh< (oc1o11 ""'forth I n FFDC,\ section 408(b)(.!J(C). \\iti<h require the El' A to give sp«lalconsldrnllion 10 c.•posu"' of infonts and c hi ld= t o the pcr dcidc chcmial residue: in cstoblishing ololcr.m<e or tolerance c:<c:mpli on. and 10 .. **cnsu~** th:lllhrn: is a rcason:tbfc

**c~:rtal n1y**  th:u no lwm , .. ill ruull to inro.nLJ and child= from •¥G"'a"l< c.•posun: lo lh< pesticide clwr nla\1 rcslduo • •• , " Addhioaolly, ft'OCA scclion 401(1>)(2)(0) rcqui"" thot lh< EPA consider -.,..;loblo l nformotion **collCmlln~** the cumul:nh .. err«ts of(• porticulor pcrlieide's) •.. r<Sidii<S and olh<r subisranccslhollu, .. a 

### co mmon mcclwlt Sm oftoxi<iiY. .. 

### The EPA pcrfonn s u number of **an.:~:ly~C:J** 10 **dctermi~** I 

### he risk1 from owc:g.aJe
**cxposu~** to paticidc residues. Firsr. the EPA d<1crmlnes lh< toxicity oflh< pesticide. Sc<ond.lh< EPA curnir>cs
**~poos:&n:** lO the- pe::sticick
**throu~** 

### food. drinlcin; w:.tcr. And othu cxpos"n:s thot occur O.J a result 

## orpcsticidoin "'sldcr.liol S<ttings. /, Summ•ryof Pnltkm""for T#l<nm« E%<mpllon 

### The petitioner R eg \Vest Compony, UC 

### 8203 West lei' St.. Suite A.
**G~cy.** CO !0634-4696 on behalf o(Lidochcm. lnc. lO Vilbgc Cour1 Hazl<1. NJ OnJO pmposin» pursuant to FFDCA section 408(d)(J), 21 U.S.C. 346>(d)(J) 

### iJ **rcqucslin~** on exemption ftom a **~l<mnce** (or Bot:lllus **<mf)~ollqr~</<K <ns**  PT A-483! in or on 

### all food commodities. Uu<illw umylo/iqrt</otl<ns PTA48381s ubiqu iloiiS in lh<

**cn vitonmcn~**  especiall y in soils ond aancuJaunl cn' i ronmcr.ts. ;\so n:sult, dicta:)' <Xposur< to

**hoc ~**  around lc\'c!J ofthe 

### 11111ur:rlly occurring microbe I'M)' alrc:MI)' be O«urring 3nd 

## ''ill lll:cl) ' conllnue to D«'Ut . D«au.sc ofils ubiqultous presence in 1bc erwl tortmttnl. no incn::::t.K in C'X'pOSUI'e to &Killus aruyloflqwfodms PTA4ll8.
**mullin~** from lh< rropo«d pestidd.ll ....._is cspcclcd 

# •men compom! to cxblins
**~~po$un:** to OOd:;round Jc,'<'ls o f /Jocll/11$ tlltf)'lo/iqwfiNIMs I Yf"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', t ho product 

### Is nottoxiclpotbogcnic ond ;.not C1Cpcctcd 10 QUfC ""'..,..
**~>Wth** 

## .rrccu. 8o<IIIU1 **Dltl)~ollqW<juclms** I'T A-183 8 has b«n dcsc:rlbcd u irreautor , 

### ,

bc:i,e. crot<rifonn \\ it

h undulote mor;jRS. lkKillllS _,toJ/qlll!/«l<ns I'TA-48)8..., grom-J>Ojiti\'e rods " it h porltricbous fbacllo allowing motility. The cells olkn appear **ulon~** <h;>ins unlike manyOlh<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"i ns 

### """ 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""' Collect ion '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 &<IIIIlSGM)'Io/lqw/t>rltiU PT A-4831 ( &<11/ou aJif}fo/lqutfo<i<JU wu pn:,.iou.l y 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/ouam)follqutfa<l<tlll ;.also used in broiler feed os o probiotic supplcmcnL 1/, Ta.cla>IDfletrlPntjllc Conilitc:nt "ilhFFDCA section 408(bX2KD). lhc EPA "'''ia''Od the o\'ollable sacntlfic dolto and olhcr n:lcwnt infoml3tion on Bac/1/oa -,tol/qwfocltMPTA-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:at l onconocmina the variability oftho scnsith· itics ofmajor 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 &<//IusaJif}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. " ;.know n to be funslcldol. os • ncrnotode suppn:sson t. ond moy oc\os • plant gro\\lh rcaulolor. 8.

**ultl}tt>llq ~~<f** **o<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 ofaction. &<//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<G I SC<d uatment aimed ot pn>\id lng protection 

### fa< seeds from nematodes and funsol p l 31\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 t brotr;h drippin ll one! ' · drcnchi"8 ot bc:t\\'e<n 3 · 32 **ouna:~in** 

### 25 ptlon.s ofwater pet 

### ocn:. - /cltnllryofth< fJ<JIIc lck and "'""pondlltiJITikh- The

**pcs~ cidc**  and corn:sponding n:siduos at< 8ld<1Ui0cd oslhtdllus amJ{olfqii<]U<ItltS PTA-48)8. The octh·c ingmllcnt""' Included as end rroduc• <=i<r on 1M end 1M pmdU<t Varni- WSP ond os • manufxwrins or seed ln:llmmt for

**Vam mo~To<hnioal** 

**.** ; \(QRnltudr ofrrsllhN ot

**tl~** tlnk" **o/ltor~~SI** utKI mttllud ustd 10 **dtttrmit~** tire
**rt.sitlu~**

**.** IJ«Iflus umyloii<JII<:focltltS Is ublqulcous Inch< en\iron.,.,L npccially in 

### soils ond t¢culunl cn'in>nrncnts •II O\'« th< wond. As • ,...,.IL d l owy <XJ10SUtC 10bockground 1<\-rls ofth< nolurolly-o<rurr!ns mic . roh< moy oii\"Ody be oo<urring ond "ill likely concinuc 10 oo<ur. The"' moy h< ccmporory lnct'COSC$ I n 1M pof>tlbl lon of B«llllll Qllt)follqwft>dtns PTA-4838 dllc to its UJC as a pesticide: . Howc\tt, this I C\-.I Is apeclod co dc:c,....lo boclcsround IC\-.:Is !IOOiloftcr opplicollon. Any polcntiolly O«urrins rcsidwl dc:posics on croP, \\ill ' no< homt hwruutS bc:coiM the stntin obows no toxicity. infcrthi\y or p:1 1.tqmk it) • ln **a~tc** 1rsu. f;vplunotlon of why an uno/)1/ml•ttthtJJ for tktt<llng and mtamring tht! f<>'f!ls oftht! patlrltk rt

sl

dutt ttre not nu asary. 

### The acute toxi city stWies 

### diKUSSIC'd in this doc:umcnl

**~** sufficiC'nl 10 show tho< then: on: no fon:s..oble human or domC..ie heohlt l=.onls likely co llri.sc rrom 1M usc of <h< produe1os ptoposed . UdoChem Inc.. ls **~<qOC1tina** an <><emption ftom!M tcquin:motl foro t olerance for on y n:siducs n:molninll in 0< on ollo!lrieullurol commodities. Since cnfon:cmcnl of n:sidue lev<ls \\1luld nol be needed. on cnfon:cmenc onol)'licol method 

### Is nol tcquin:d . B. ,11/crobia/ Pestirlde TOJtiCOIOfO' DQ/o Rtqulr<nttni'S All"''!'l icoblc mornmol ion tox icol ogy clato tcquimnencs supporting th< tcqiiCSI for on oxcmp<ion from 1M requlrc:mmt ofo tolcroncc for residues of
**/k~r/1/us** anr)10llqtit]tKitiJJ PT A-48)8 in or on nil food commodities 

# Jto,.., bc:cn fulfilled 

### ,.,;Ill cto... submintd by 1M pc< i tion<r o r ro.llon3Jcs ond supportin ;: intol"nUiion 10 :tddn:ss SP« i r.c cxposun: a.nd hmlrd sccn:uios. Tbc IOXIcicy t<:SIJ (liC\liC or.JJ, dermal, ond inNJot ion I OJ(icily) ond iniiOiion I<:SIJ (oc:ul< eye ond primoty dc:mullrritollon) that lllldteu potcnllol routes of

### opomn: to lh< 

### ocd'"ingmlicnl on: oil clossiflcd in Toxlci1y Co«;ory Ill or IV ond rc\-.:olliulc 10 no coxiclty or lrritotlon ouributcd co &cillus am; f

ol

lqwf«I <N PTA-4831 . Mon:o, u, duri"':DI)'Pieol dcrmal<oxlcicy 1cs1 dono \\ ith mien>bial pestici des, lla<ll/us **um)follqt~tjocltns** PTA-48)8 showed mlnlllllll slsns ofdrnnol irritotion. Finolly,IM p:titioncr rqiortcd that, lo dOle. no hypcrscnslti,ity illci clcncs M\'C O«urn:d duri ns 

### =h. **dC\-.lopmcn~** ond 1 01ins of

### !his boctcrium. ' The concl.Wonslebosifieolions f rom allt o.ori<closial infonnollon submint<l by 1M pcti lion<r on: brieRy dcscn'hcd below.

**Vprnfmo Tubnic-111**  "'""oral to.<lc ltJ

{ pot/KJgtni<lly (1/mntonl:ttl Gul thllnt /JlJJ . JOSO: MRID No. **~9l7~/0S)**

**.** No monol it y W:tf obsen-.d durinj: 1M coutJC: oflhc stud y. Thc spl ccn.lh ·cr . ond mncntcric l)mph nodcs wcA> sho\\ins pollem'S ofcltiU1U1«: by doy 21. but hod not completely cl<11n:d lh< 

### .«>' subSion<c . The lungs. whore on O\ ' <rllj;C of 1.9 < 10' CFU /g W:tf n:col\lcd on clay2 1 in 2 of!M Slest onimals. The other thr<e test IIIli miis show<d. complm pollem orcleot>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 "'"rollpottom orclcolooo:. 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 t he 

### lung Amplcs 00 

### cloy 2,1 may 

### !]a••

**~** contam i nolcd iD two orll1c test llllimols. Complete 

### clcanu><c ""'rocomcd in the IWIJ;S ror theAc"'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 ACIIItpu/_, ' t01f:ldl}( plllhogtnlril) • - rtJI :md ll1cAt'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 I0' CF\1 /rt>t, Acwcpu/mottar) •toric/1)1 pothog<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 con t rol a gent (MPCi\J at • si n al< 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 

### infecth-e And 

### non·toxit to mlJ "hen :ocfmlniJiard b) •uad>c::ll lnjcct lon in ulna!< dose oO.I x 10• CFU/s or 3 . 1x IO'CFU/raL A<lll< lnjcC'IIon toxl<lt)'lpot/togrnlclty (1/ormoni:rJ

### Guidtllne 88H100: MRID 

### No. **~9~U/0 7)**  **.** 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' 

### CF U/; is considered low 

### arid cOnsistent "1111 on 

### o, •Cn.JIpottom 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. lnd lcotina 

### lhll thc 

### lung Amplcs on 

### cloy 21 moy h;m: been 

### conlln\in;ltod in l\\'0 o( l he I<SIIIIIimols. Complete 

### cl..,.,.. ""rocomrd inthe lunas ror the Acwt pulmonary toxlcll)fpath08<nlclty - · rtll study, which llmher confirms a pottan 

### orclQI'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 10 1 CPU pa !"L Acute Toxlco/OfO • Wan'" Rrqwst. ( /lormonl:eJGuiJ tllnr 1170 . 1100. 1100 . /JOO. UOO, l$00; .IIRIDNo. **~9~7~/08).** Aaitc ora l , 

### 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 inilll l ion 10""'volid b<cousc the sludi<J "'"" 

### bocn pcrfonncd "itb Vomimo WSP, and the studies""'""""'" the lest subslontt 10 be non-toxic. ll""'<'n, the Acu"' Ocnnol Toxicicy study for Vomimo WSP · pl><cd tho I<SI S<lb>loncc in Toxi<ily Cotcaory Ill for lob<lina pUIJIO'CS. The woh'C1' I'C<IUC1tlhus

obo pl>ecs the usc ofVom lmo T«hnicoliST in Toxic ity COiqje>ry Ill . 8:>sa! on the I'<SUits from the

**;\cut ~**  Dcnntll ToKiciay And Acute !.>cnmllrriur1ion IC:SU for Varntmo \VSP. o diO'crcnt **oUl~** in 111< dcnnoii<Siinll **ofV~~t~~lmo** 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 inform111ion conccmins cxposun:s from the p<>ticidc <diduc in food and oil 

### other non«cup:uionol C'J<posu<a. includin; <lrinking w>Ocr from Ground \I;UCT or surfocc WDICT and ""J'JS'Sft' thtoueh
**p<S~icidc** usc In 

## canJcns. IA\\11$, or buildlnas (""'ldcnlialond ooh<T indoor uses). Foo<l Eiq>nmrr: floc/1/usant}o/ollqu<[«ltns ;.ubiquitous in the cn•ironmcnl, cspcci•lly in $Oils and •ll'iculluml cnvimnn><nts. As • **n:sul~** dlcwy C'J<posut< 10 boCkground lcnb ofthe nol umll y occurring microbe m>)' alrc:ldy be: occurring. In situotions 

### \lilcte oppli c:otions ""'closer to """"" times. rmdu<J on crops oro ""peeled IO be: hishor lhon normal bod<ground IC\1:1$. Ooc/1/us **amJto/lqu<[odt~u** wos prc•iously cbssifocd os &<Ill us subtllls '""· **ant]oioliq~wfa<IMS.** Ho\I'C\ 'CT, lhc product contoinlng 8«11/us OIIIJo/o/lqwforltns is nolloxiclp;othOgcnio and is not cxpcc1cd 10 cowc odvcnc h<ollh cO'CC1s. Simi111t Bu<lllus suhlllis Slrains..,.. used lnlcm>liomlly in the production offood 

### llfOdc p<Oducu and in fmncnocd foods in Jap;on and Thoilond. floc/flus su/nilis sp. orcl:no"111o <liUSC spoilogc in doueh. and lltC =I)' found 1 0 cousc food poisoning (Ref. 1). llctw""n 1990-1996 len diO'Cf<nt foods""'" bc:cn IJSl!OCimd \\ il

h B .sulnilis foodhomc: i llness out b<caks. Olhcr infi'C<lucnl c:ucs hA• · c bc:cn **rrpo~cd** os well (Ref. 2), buc no r<poi1Cd illnc;scs hA\'c h«n IIS$0C'i:ated wilh Boc/1/u.r
**um;~nllq t;Qf~eltns**  PTA-4838. The pn:SC11C< of /Juc/1/u.r amJ1o/lqut[aclt111 PTA-4SJS residue on crops poses little 10 **no~** bos<d on the ll>l<icily/p<>lbo!.'rnicily <IUdics. The 

### rUI: posed 10 odults, infunts end children from food rei>Ocd <'Xposurc 10 &1<11/uJ **iml)o/ollq~~<[a<lrns** l'l'A-IS381s min imal due lo the dcmonslnllcd lock Of XUI< omlloxichy /pothogcni<ily !WiOtblcd -.ilh the miaobbl 

### pesticide. Dria•ftw fYglfr 

### E.vwurr: (ikldl/111 amyfollqutf(J(itns 

### is ubiquitous in 

### the **awironmc:~u.** 

### nnd c>pos= 10 the microbe: is lik<l yoccurrins •1 bocqround lc\'Cb in the <lrinkin; w•tcr. The intended usc offlocl/lo« OIIIJ{o/lqut[acltns PT A-4838 l<e:ltmcnl on gro\\ing crops or
**~** I/C41mcnl for pfonl discDSO <0111101 rnoy «$Ullin lhc polcnliul for drift or runoiYwhicb could rt;>(h surf4CC or ;round WilletS. &1(//lus aMJiollqwfa<itns o.nd 8«11/us n•bllllssp. ore not .,.oanizcd oqu>olc bactcri:a 

### Mel ore not

**e~ r«l«i**  to 

### grow in aqwtic; cnviroMlCnts. Munic:lp.1l drinking wotcr ""tnwnt P"'<"SS<S and doq>

**"~'""** \\'Cils reduce pocmtiol raiducs. E\'<ft ifomle:<_.,lolllis ubiquilous microbe: shoultJ oteur
**th~a h**  drinking w31eT,

**d~** to 

### itJ ckmonstnucd Jack o(DCUtc: oral, pulmoruary, lnjccdon 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.** 

### i ncluding infaniS and 

### children, becousc Bo</1/u:r **Glft)follq•~<foclrtU** 

## u ubiquiUMG i n II>< 

### cm-ironmatl ond 

### becousc **pop~~lo1ion** 

### ho,·e been 

### pmiousl y exposed 10 bockiJfOund IC\ • cls oflhc m icrobe. !Iuman cxpo>uo: 10 Bocillus SIHN/I u in 

### food 

### iJ'ICI< products 

### or fcrmcn!Cd foods ho'"""'resuhc:d in any

**~qX>ns** 

### ofinfection. A few rorc exceptions Include reports 

### lho1 B. s ub/ fl

u hos 

### coused ''«) ' 

### infr<qUCOl foodbomo illness <4S<S. 

### Any oddilion:alcxposur< loll odl/us a•l)·lollqwfarl<ns 

### PTA· 4838 

### rcsuttina from residues 

### fnom

**pes~i cidol**  ""'andrcsidcnriol 

## homco'"'a- applialions "ill not raullln oddll ion:U aurq;alcnon a«upot loMl riolc. 

### sl""'no. aculc oral, pulmonary, and 

### injc:\.'1ion IO:<icily l pathoacnicit)' h:lmtd 

### exists. V. **un~ulath ~**  Erf tcts Croat. **Sabstantc~** 1dllla Common M«banbm **ofTostci~ ·**  

### Section 408(b)(2XDX v l 

### 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 o lhor 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 t hrough an CftZ)mc lhot is 

### JIIOducc:d. II. om)'lol /

'fl'tf«kru 

### PT A-48}11s dtillowo, proi<:ISC, and 

### IIpose 

### 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 

### stra in I 'T A-4838 

### to share 

### o colllmO<\ 

### m«honlsm ofto>l <ily " it h ony Olhcr "'boaanca. slocc it is 

### not toxi c vio tho c>c>l. dcnnol. or inhala.dOn routes o(exJ'INiun:. For the- purposes of this toltnnCc octio n.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 EP A

·s efforts 

### co dctnmine 

### "i\idl 

### chem i cals ho\'c • common mccbonbm ofloxicily and 

### 10 C\'alUOie the eumul41i\ • e erT cc ts ofsuch chemicals. S« 

### EPA's \\-.bAt e ot

**http :ll**  **uYM' 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 

### n o 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 othe r cxposuo:s for which 

### lhorc is 

### rdi>blo informotioo. B. lnfws and Chi ld= 

### FFDCA SCC!lon 408(bX2)( C) provides 

### !hot lhc 

### EPA shollopply on oddhionollcnfold (lOX) 

### "" "S in ofsofe1y for infonlS and 

### ch ildt<-n in II>< 

### auc oflhrcshold crTCCIS 1o occoun1 for **prcn~~LDI** and 

### poslll:llollo xicily and the complct c

nesso flhe da10bosc on '""icily and 

### e x

posure. unlcs.s II>< El';\ 12dttamincs 

### b:u<d on n:lioblo doll! thot o difTtrent m>rgin ofsafety will bt safe for infants and childn:n. Tioi s odditionol moq;in ofsafely iJ commonly n:fcmd 10 as l ho Food Quality Protocolon A<l S:tf<l)" fo<lor. In OJIIIl)ina lids pnl\ isiOn.lh< EPA cilh<r r<l:llns 1h< <kfaull \-.IUC or lOX or ..... o difTcr<nl odditionol$0fcty rxoor when r<lioblodomo•"lliloblc to tho EPA oupport tho c:hoi« ora difT<:m1t foetor. Humans. including infant$ ond

**c~ lldn**  **:n .**  M\'< llkt l y btcn exposed and <ontinut to bt .xpoood to llodlhu U"')foliqtt</o<ltns tlwu;h JOil and rn:sh produ«.
**"~it** is
**eacnn~!l)**

**·** found. with no knawn or n:poned od,..,.. efT«<S . As di.tcuSS<d oba,,.., tho EPA Ms ean<luded IMt Bad/Ius **unt).,ollqutfircl~"s** I'TA.-1838 is not to. xic,

**~1ho gcnic,**  or infccti\-c 10 **manu:n~~IJ.** includina: infonos and <hildn:n. llcc"auoo th<r<""' no thn:shold ln,..b ofeanccm 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:><t iccs. tho EPA eon <lud<s tMt no oddiol"""l mMJJin ofsofoty 

### Is n«OS$III)' to protc<l infoniS and ohildn:n. Tho E Pt\ oon<lud<s thot th<n: Is • ,...,.,noble <crtointy tMI no honn "ill n:sull to the U.S . popuLlllon, induding inf3l\tS and childn:n. from
**IS~tc** oposutc 10 residues of 8«11/II.J Utn)foliqu.fotlms PTA-1118 duc to olxk of to•i<il)". Th<r<fon:, an c:xcmption from the r<quimnent of. tol<ran« is cmbllshed for r<Siducs or fkl<lllla Unl)follqllrfo<lms PTA-18)81n or on all food **com~ltlcs** when used in a<<on:lan<:< "ith lob<! din:<1i011S and good ogriculturDI pr.><ti=J

13

### f1FRA CBIAPPENDIX

l4