,

# .. ' 

## '

I " • • '+ '

## P~opose~**Registratio~ :e:~** **ision (~r** **,. the**  

## Ne.w Actjve Ingredient 

# Bacillus: tlturillgiensis subspecies 

# kurstaki ·strain EVB 113-19 ' ' " 

## ,,

' '• Dtt<: '· ' '



### , 

# .. 

# I ·

### J. 

### Summary 

## '

. This document announces that the Environmental

### Protce~ion Agency (EPA) 

### has coniplci'cia its ·• inilia.l t\'llluation of the proposed new microbial pesticide aotivc ingredient &iclll "f_

### i;i**ltmls** $\lbspeeics /nusloki strain EVB I I 3-19 and 

### has concluded thai it meets the reguhuory.llild 'safcly Slllndards under the Fcdemllnsccticide, Fungicide and Rodenticide Acl (FIFRA). The agency ' is seeking public comment on its proposed decision. Badllw thurlngltnsls subspecies lnustaki stmin EVB 113·19 originntes tiom Bacillus thurlnglensls subspecies lnustaAI stl'llin HD-IIItld Dipel WP (EPA Rtgistrution No. 4-252). Bacillus thuringltiJSis subspecioslnustald stmin EVB-113·19 

### was rcgistorod yoars ago "ith Cannda's Pest Management Regulatory Agency as stmin HD·I. The name \\'liS then changed during a subsequ<nt roview of the Canadian registration to stl'llin EVB-113·19 so as to have unique strain identilic:alion. Bac/1/usthuring!tnsls , sul!specics kurstoki strain HD ; I was n:gistoMd 

### Mel comriien:ializc'd**in ~**  

## u' oii

l'*''stl.iO. in ' iJic:e'ni J y 1970.: Jdctiii lic:atiOn as Bacillw ' 

## . ' 

## . 

# . . 

## . 

# . 

# . .. , ., thuringl tmls·su!ispecies kurstakl using 

### standanl bioel?<miea! , phmotypic ailll serologieal**~** •· methods. plus comparison of

### the ayprotein

_ gcnes 0)' I (\a, c ry JAb. ay lAc. cry 2A.IItld ay 28 lltld side-by-side insect toxicity OSS3)'; "ith ' c'

um:ntly**~sten:d** acth1: ingredients from Foray and Dipel products show these stl'llins art indistinguishable

. However, Bacillus thurlngitnsls subspecies kurstald strain EVB 113·19 was n:quin:d to obtain a new active ingredient n:gistration since according to 40 CFR Portl58.2100 (e) (2), [ e)ach n n dsolatt of a microbial ptJI/cl dt Is a ,..... act I\'<' lngrtdltnt and mwt bt rtgisttrtd ind t ptnd t nJ/y of anyJlmllorly d ts ll{71altdandalrtady rtgist<r<d mlcrablalptstidtlt actl•'r lngrtdienl. After revi t\•ing submlued and publiea!ly available data lltld infonnalion, EPA concluded that this new active ingredient is 

# eov efcd by the oxisting toleranee exemption (40 CFR Port 180.1011 ) for Bacillus thurlngltn:rls and 

### will not cause any unrmsonable adverse effects to human health or on the emironmenL Therefore. 

### the Agency is proposing to n:gister the microbial pesticide manufacturing-use product containing the new aoU\'C ingredient under FIFRA section 3(c)'(S). '

- 

### 2. Background On October 14.2014, 

### the U.S

. Environmental Protection Agency (EPA) received an application for n:gistrulion for the new microbial pesticide aeU\ 'Cingn:dlent Bacillus thuringitnsls subspecies lnustald stl'llin EVB 113-19 from AEF**Glob.\~,** 

### In<: , Bioprotec Tccbnieal 

### is atechniea! grade aetivc ingredie p,ll'!"'"ufncturing use product (TGAIIMUP) to 

### bt formulnted into insecticidal prodUciS f or foO;d and non-food commercial 

### and residential uses outdoors. in greenhouses. 

### and fon:sts

. The applieanl was not n:quin:d to submit a petition for a tolernnc:e or an oxcmption tiom the n:quimncnt ofa toleranee for residues ofthe active ingredient on food crops because the new active ingredient is covorod by the oxisting toleranec exemption for Docillus thuringicnsis. 40 CFR 

### Port 180.1011.

Pagc 2 of14

### 3. Evaluation In C\'Oiuating a J'<'{icide registnllion application. the**EPA~** 

### a wide ''llliety ofstudies and infonnation to detcnnine the likelihood ofadvers<' eiTects(i.e

.. risk) from e<po:ruh:s associnted with the prop<ised usc of the pmdueL Risk ossessmcnts a"' developed to C\'llluate how the compound might oOilc:t o wide range ' ofn<in·tilrset orsanism.<. including humans and tem:strial and 

### aquatic \\ildlife (plnnts and 

### animals). · Rased 

### on these assessments, the EPA C\'llluotes and 

### OpPrO\'es conditions for cnch pesticide product to ensure that pcnnined 

### uses and 

### safety meo.rures 

### nrc approprinte to mitigate any potential risk. · I The 

### human hcnlth and 

### en\ironmetltal risk assessments supporting this decision can he 

### found in the regulatory docket (Docket Numb¢r**PA ~!J** **~PP-2015-0419) .**  

### 3.1 Assessment 

### of!Wk to Huma · n Htalth



# . ' 

### In order**to~** a , 

### microbial pesticide's risk t(! human

. h¢alth, the

. 

### EPA initially requires a .wide range ofstudies, inchMiing Tier I, I!CutC toxicityiP"tbOgeni c ity (orul, pulmonary, and 

### injection) 

### da!a, cell culture 

### dati.,**rcports ofhypCrsensiti** **ity i~cident;** **~ut~** 

### toxicity (orul, demtol, 

### and

. inhalalion) 

### data, and irrillllion (detmal and 

## •>1 e) 

## <loti Tier 

### II and 

### Ill testhigtc,g_, subchronic ' toxicity i ..,thogenlcity) 

### is tiigs'crcd' oilly 

### when there is indic:ation. usually' through lower tier testin8, that 

### o'mic:iobial j>e'sticide 

## has unusUal toxioological

### chaiucteriSti~ sUch 

## 8s infccti\ity or
• ' ' ' • I • ' ' 

### bcmg suspceted 

### as or knc\\n to be 

### a ca...mogen.. 3.1.1 Product Characcerizalioo and ApplieabDity of B•ellluschuriogi<a!is To Iorance Y. • ., ' ' • • 

### Extmplioa, :JO 

### CFR 180.1011

. The 

### identification proc:iess for Bacillus thuringicnsis subspecies kuisiaki Strnin EVB-113-19 adequately dernoll$tratcd il

### is 

### a'sulis'pcc:ic:S ofBocillus tliuringieitsis 

## llerlli.cr oonfonning to the 

### mo,.Poologii:al and 

### bioehemical cboraeterU!ics ofBaeillus'thuringiensis 

## .S dcs.!ribed in BCrge)"s Manual ofDeterminati\'e Bacteriology, 

### Eigbtli Editio.l. The 

### produecion 

## Proci:s$ fo' r Bacillus

. thuringi..lsis subspecies kurstoki strain'EVB-113-19

.includes 'pun:

### ~ture fennenuition 

## and quality control procedures. 11>c 

### description ofthe manufacturing process pro,ided sufficient details for production, and 

### for discarding any potentially oonl4111illllled botches. 11>c 

### discussion of formation ofunintentionhl**in~ients** 

### pro\idc:<f clcor qualily e , ontrol steps used 

### during pro<!uction. and,thorough steps to determine that the 

### active inBrcdicnt 

### is**proo~ w;!){**  fidelity. J\ccepl4ble

. rcsulls arc provided for the 

### analysis ofsamples. The'cCnified limits for the octi\'e and 

### i,ert

.**in~ients** 

### arc within their respective OCSPP-recommendcd limits. ·• '



# . Submitted data wen: rc\iewcd in order to determine wtietlier Bai:illus thuringiensis subspecies
• • • • • • ' I ' '' ,• ' ' 

### kurstoki strain EVB-113·19 wos 'eovercd by the existing Bacillus lhuringicnsis foOd tolerance exemption at 40 CFR 1110. IIlii. 

### While this'FIFRA scetion 3 ic8Jstration'is a ric\v action, this Poge3ofl4

### strain has 

### been registeffi! llDd sold in Canada for O\'Cr 10 yoan. 

### and the soun:c 

### is from 

### an**E~A** 

### registt:ffil pesticide on the marl<et over 40 years. 

### &ciliU5' thuringionsis subspecies 

### kumaki stmin EVB-113-19 is in the Bacillus 

### cercus group 

### of

### Gnun P,OSitivc microbes. Based on animal testing ofthe Bacillus thuringiensis subspecies kurstaki stmin EVB-113-19 oetivc ingmlicnt no toxicity, inilation, infect ivity, pathogenicity or 

### other ""':crse effoc:ts 

### liom dietary 

### exposure to Bacillus thuringicnsis subspccies kurstaki strain EVB-113-19 

### ore C!'peclcd. )laciUus species ate 

### primarily soi l nnd 

### water associated nnd 

### ore commonly fowid in 

### a variety offresh produtc: nnd 

### other minimally processed foods "ilh 

### no ill effects from ingestion. A litc:ratun: review reveals that Bacillusthuringicnsis subspecies kurstaki has

. oot 

### b,cen shown 4S 

### the 

### cause of any food 

### borne i!IDCSSCS. In alignment with the 

### provisions ofthe Bac:illuslhuringicnsis tolerance exemption under 40 

### CFR I 80.1011, live batches ofBacillus thuringionsis**su~es** 

### kut51Aki strAin EVB-113-19 wac 

### tested using subcutaneous injection ofat least 

### Jmillion spores into each of ti\·e labonllory lest mice weighing 17 grams 

### to 23 grumslhcn 

### observed for 7 days 

### follo"ing injection. No apparent sign of infection or injury at the injection sites ofthe mice\\= noted during the 

### obsm'lltion periods. 

### Similar ncgali,•e testing is required**for?."~ ermcn~** **~t cb** **ofBac:ill~** 

### , lhuringiensis subspecies kurstaki strain EVB-113-19 produced for formulation ofany manufacturing-usc nnd 

### end-usc products. 

## lJ>e ,potential for**~xo.t'!xin ~nee**  

### was liSSliY.ed, using a 

### fly lar\'110 toxicity test. Three' botcheS of

### master sC:ccl stock> tested negative 

### as 

### ccimp<ir<'d to 'untreated controlS: with no fly 131\'l!C stunting or'def ormity,llDCI' slmii .;: numbers' ofli\'C 

### larvae at ihe en(! 

### ofthe 

# si!Ay incubation**~vben** 

### dOsed with 2,105 ppm 

### 'Bacill uS_ ihuringionsis sUbSPcci.S kurstaki stmin 

### EVB113-19: Each new mast,er seed s1oek bmught 'into pioduction , or PJ:i:!Oclic iCSiing after" spore , h31\·est muSt similArly lest negative for

### !~-exotoxin' 

### .,loduction. 

## FWther, the 

### aC\i,· e inSJ:Cdlcnt Bacillus thuiingiensis 

### suh$pccie$ kurstaki strAin EVU: 

### f 13-19 was chosen fo r**eoriun~ial** 

### use in 

### pan because 

### it is not a kno"" ll-cxotoxin produur : As 

### discUssed in the 

### 1998 Bac:illus ' i

lik inS;.n..iS

### Re'regiSIIllti~**':l .**  !lli811>llity

### DocU~t'~t**.** RED). the Agency bas no ''lllid e\idcnccto link actual usage oflllkill us thuiingiensis iiisectiCidi:s "ilh episodes ofdiarrhea f'!llowing ingestion offood llDd belleyes that

. the**cu~nt** 

### uses ofBacillus thuringiensis 

### ore not 

### likely to contribute tO' the 

### pn:valencc of

### dinrrliea induced 

### b)' microbial toxin$ in improperly s1orect 

## pn>C<s;sed '.foO<I. 'IJie (.'scney .. 

## ;u continueto "survey 

### the scientific •. lit=tun:. including publiaitions ' from the C oni er.. for Disease Control on inc!dcntsofBacillus · food poisoning. nnd 

### "ill reexamine these 

### conclusions if valid evidmoe 

### iS found 

### lhili ;,..ggests
... direct association tiet\\..en Baciii..Sttiuringionsis usage and 'illncss. (Ot REo). '· ' '
3.1.1 

### Toxlelly A literature review for toxicity, patliogenicity, or infC.:ti\itY tulncd up 

### no new n:lcvanl bc)tlth effects anribulableto Bacillus thuringienSis 

## SliainS. Studies"..,.. ' cited nnd 

### submined and "-'llivef mtionalcs wore 

## pro\ided. Accoiding to the 

### Bt RED, ·" 

### 'Th< '!g<ncy has an**histw;lc~! toxic~l** **'?gr.tif! a**  

### bas.< for 8«11/us 

### thw;lngltmls**~·** 

### 4123186 Mtmorandumfron i ll'll ( iamll'oodroK ; to Arturo Ctiitillo)

.. fn addition, a 

### sinnmary rn•itw of 

### mammalian toxicity s t ud ies 

### l.·aiptibllshtd by

## Agency

. 'rtvir:•<' in'(McCIIritock. 

### J. T.. C.R. Schafftr. t. ' ' ' I I 

### Pagc4ofl4& R.D

. Sjob/ad (/99$) A

**Cmnp<Uall\~** Rn11ft4 • ofthe Mammalian Toxlcll)tofBaclllus thur lnglrnsu-IJDMd I'UJicidts. PUll<. Sci

. 4$ , 9S-JO$). To dal<.. no .bocnm mammolian Mallh rfftt:IS

**hat~** bren

**demonstra~rd** In arry lnf<CIMI) r palhogmlcil)t stU<f)•(Table I. Acute Mammalian Tax/ell)! for Bacillus thurin glrnsls)

. The sum total of all toxicology data submllled to thr Agency comp/rt<with tilt! lock of anyrtpor/S of slgnljlca nJ human ht!alth hazards oftht \ ' orious Bacillus thurlngl rnsl.r strains allow the conclwlon that a/1/nfrctMI)vpa lhoJ:tnlcll)t studies narmaiiJ' rtqulrttl under -10 Code of Frdrral Rtgulat/ons. · Part /SIJ.for tht tLft palltrns oftht nglsltrtJ produm bt

**tt'DI1~d** In tht fUJiut as long a.rproductldtnJ/1)! and nwnufocturlng proctss ltstlng data lndlcaltd lhtrt Is no mammalian toxicll)tassocl al<d with thr strain, In accordance wit h standard procllr:<s wht'n thtu studies art wahYJ. /alwllanguagt w/11/w rt

qulrtd assuming a Toxicil)t Cai<Jlory of Ill. Tili! Wtr and Par!Jaunlcltr Submiued acute omltoxicity fpolhogeni city data clcmonstnlte ibol Bacillus thlllingiensis subspocieslcurslok i strain EVB-1 13-19 does not appear to be omlly toxic, infccti,·c, andfor pathogenic in 11115,

... 

## n.n dosed al3.5 x 108 CFUfanimal. Cited acute p<tlmorwy toxioity f pathogenicit)' and ocutc i ntral'cnousloxicityfpathogenicity data for Btu:illus thuringiensis subspecies kurstaki demonstnlle no 

### lldverse toxic ctTociS, infectivity or

**pathot~enicity** seen at dose's up to 2.6xiO' 

### sporcs'lkg via the pulmorwy route and at doses below lo' :spof0$1animlll via the intr11vcnous route. ' Toxlcltr Submitted DCUte oral toxicity 

### <lola on Bi oprotec Techniall (Bacillus thlllingicnsis subspecies k urstllkl strain EVB-113-19 (9.9 

### x 10° total CFUfmL; spoRS"9. 1 

### x 10' CFU f mL ) demonstrated it to be not to!cic ala dose level of5000 msfKs body weight and in EPA to x !cityeaJ egory 

### IV for oml t oxicity

. Cited dermal toxicity data on Btu:illus thuringiensis subspecies kurstaki dcmonstnlle no toxicity at doses up to 4.7xl0 11 

### >Poresfks and 

### lhils BioprotecTechnical is in EPA' toxicity Calegory 

### IV for dermaltox i city. • Bioprotec end-use product data demonstrated ibol it is 

### tnlnittWiy itritatiQg to the eye. further. 40 CFR IS82140 foelnote Sstates that [t)h<! 170 $0ricsSIUdies for the M P and EP are intended to provide data 

### on the acute toxicity ofthe product. Waivm for ony or all of

### these stuclies may be aronted when the applicant 

### can clernonstrme that the eombinotion o f inert iiiSJCdicniS is not l ikely to pose any sisnifocant human be:llth 

### rUla. Gi'-cnthe formulation ofthe techniall and the results ofthe end-use study,the clal4 requirement !s satisfied and Bioprotec Techniall is in EPA Toxk it

y Cftlegory Ill for C)'e irril4tion. Bioprotec end
- IISC: produ<t clal4 demonstrated that it is minimally irri l41i ng to the eye and dermal d

ata showed s igns ofirriiAlion that subs i ded

. Further, 40 CFR I 58.2140 footnote 

### 5 stales that (t)he 870 sories stucl ies for the MP and EP 

### are intended to provide d olo on the acute toxicity of the product. Wah-.:rs for any or all of these stuclies 1t14Y be grunted when the applicant can demonstnltc that the combination ofinert insrcdieniS is not likely to pose any sisnilicant human Page S of 14

### health risks. Oh'enthe fonnulation oflhe tcchnic:al and 

### the ....,luoflhe'en<l·use studies.lhe data n:quimncnt is satisfied and 

### Bioprotcc Technical is in EPA 

### Toxieiry Category Ul 

### for dcnnal 

### irriuuion. 3.1.3 Aggr<gote 

### oud Occupational Exposure



## . ' • • In 

### e.•amining aggregate
.CXJlOSUI'O> 

### section 408 

### of FFDCA 

### directs the EPA 

### to consider t»'allable informtUion conecrning exposures from

. the

. pestieide residue in food and 

### all other noooec:upational cxposwes, inc:luding drinking wlller

. from ground 

### water or surface water and 

### exposure through pesticide use in ganlens. lawns, 

### or buildings.

. Food /i.TfJl),!l!!( 

### and Risk Charact<ri:Oiion: The use pallcrns for Boclllus thurlngitiUiS may rcsult in dietary exposure "'th possible residues oflhe bac:terial spores on raw ogrieultural commodities. However, in 1he absence of any toxieologic:al concems, risk 

### from the consumption of treated commodities is not expcc:ted for both the 

### general population

. and 

### iufanu and 

### childn:n. • •. r 

### Drinking W01tr E.mfl.!ut< 

### andRisk 

### Chqrqrtuligt!on: , There is minimal potential for Bacillus thurlnglrmis to enter ground 

### water
. orothet; drinking water 

### sources. and 

### 1he bacterium does 

### not proliferute in aquatic habitats. Thus,

. the potential for drinking 

### watcr
. eXP.')Sute is 

### negligible. In addition. the health risk is**CXP.CCf~** 

### to !lc

. negligible ducto: (I) The 

### ! ack oftoxleologic:al concerns associated "'thBizclflus tlrurlnglcns/s, and (2) 

### Bacillus thurlnglrmls has been used 

### as a pesticide for approximately 

### SO years \\ith no known adverse effects. Non.growellonal. 

### &.<ldcnt/i!IB!sk Chorqmr!za!/on: 

### No indoor residential , school or daycare uses currently appear on the 

### label. Non-,dletary exposwc to these other use sites could oceur where children 

### ore prcsent. butlhe bealth , risk is 

### cxpcc:tCd to 

### be negligible due to: (I) the 

### lack of to:deologieal concerns associated "'th naclflus lhurlngftnsls. and

.(2) 

### Bacillus lhurlngltm/s has been used 

### as a pesticide for approximately 

### SO years with no knov.u ad\'CNC 

### effects. Acute 

### and 

### Chronic Dlewy 

### Risks 

### for Sensitive SubpopulatjOI!.S Panjculady Infants and Children A 

### baucry ofaeute toxieily/pathogcnieitj studies is , considcrcd sufficient by the 

### Agen<:y to perfonn a risk 

### as=mont for microbial pesticides. Furthennon: , the Bacillus lhwlngi•nsis.dclta· en<lotoxins 

### affec:t inscciS via 

### a well-known mechoalsm in which they bind to unique n:ce)l(or sites on the cell

. mcrnbrune of,lhe insect gut, thel):by , fonniug pores and 

### disrupting the 

### osmotic balance; Thet): 

### ore no knoom equivalent receplor sites in mammalian species which 

### could be efl"ccted, reganlless of. the age 

### ofthe 

### indiyidual: Thus, 

### theti: is a 

### reasonable ecrtainty that no honn 

### \yillrcsult _to any subpopullllion including infants and 

### children from dic:tary 

### e><poswc to rcsidues ofBacillus lhuringl <c

nsls. · ... , , ' Qm,pgrtonal &p9.fJ!!t: 

### Because ofa lack ofmammalian toxicily. the risk from occupational e><posun: is minimal. No additional exposure data 

### or changes iD 

### 1he proposed labels to restrict exposun: nn: 

### m:ornmcnded at this. time. I·



### Page 6 

### of14Agsregate ExDOS\!R from Muhiplc Routes Including Oral. Pmnal 

### and Inhalat ion Bacillus lhuringlensls is a notwally oc:c:ulring soil boA:Ierium. Anyone coming in contoct with 

### the soil is likely to be

.. posed tn this microorganism.**~usc** 

### the bealth risk is o.xpccted to be negligible for oral, dermal, and Inhalation cxposun: routCs, 115 stated**abov~.** aggregate
.. poswe by these routes, from naturally <icculring populations in 

### the soil and from the 

### usc ofpesticidal products. is not expected tn pose 

### an unacceptable risk to human health•



# .. 3.1.:3 Humoa Hoaltb Conclusion ; The EPA eonc:ludes that there isa reasonable certainty that 

### no harm v.ill result to the U.S. population, including infants arid ' chiI 

### elton. from o'ggregate

.. posurc to nesidues ofBacillus lhurlngl tnsls subspecies kuntakl strain EVB I I 3- I9. The EPA does not expect dietary (food 

### and drinldng water) orother non-occ:upational risks from 

### usc ofthis microbial pesticide 115 

### an active ingredient in 

### the pesticide product. Althoui!h · exposun: . to Bacillus lhurlnglem/s subspecies .l:uma.ti strain EVB · I 13-19 through·coiUUIIled food and drinking \Wtor is possible. 

### the EPA anticipates these types of

.. poswes 

### boscd 

### on Slipponing toxicological iriformotion 

# ,.,;n not result in odvcrse <fleets. In addition.·the Agoney has dctcrmined that Bacillus thurlngltnsls subspecies kunta.ti strain EVB I 13-19 is covered by 

### the

.. istingoxornption from 

### thC requimncnt ·ora toleronee for nesidues ofBacillus thuringl tnsls on all agricultural commoditics, 40 CFR Pan 180

. 1011. For more information on 

### the human health risk assessment ofBocliiiL< thurlngltnsl s subspecies kunita.ti strain EVB I 13-19 pleose 

### seo the supporting document in 

### the associaled regulatory docket (search for "EPA·HQ-OPP-201 S.Q419" at**hllp: 11** **111W r.gulatlnnv** **~m·).** 

### 3.2 Assessment ofEeologieal Risk 

### " ' In order to 

### assess a microbial pesticide's risk to 

### the environment. 

### the EPA initially requires 

### a "ide range ofstudies. including Tier !testing dono on the following non-target organisms: birds (oml and inhalation), mammals. fn:sbwater fish and invenebratcs. estuarine/marine fish 

### and invenebmtcs, plants, insects, 

### and honeybees. Higher tier testing (II, Ill, 

### and IV) generally oneomposscs definitive hazard dcterminations and longer t<nn greenhouse or 11eld testing and 

### Is implernonted only wben unoceeptable effects are seen al 

### the Tier I scn>ening level. The primary oeological issue for Bocl/lus ' thurlngltnsls 

### raised in 

### the 1998 Rerogistration Eligibility Document 

### 181 in'oh'CS the oxoloxins that may be produced during manufacturing. Daphnia magna testing was required 115 

### the most scnsiti\'e 11SS8Y for these oxotnxins. for 

### the aeri,·e ingredient Bacillus thurlngltruis subspecies kursla.ti strain EVB 113-19. tbc databi1Sc ofstudies aDd information required to suppon 

### the asscssmonl ' ofrisk to the environment iscomplote. · Bocl/lus thurlngltnsls subspecies kursta.ti 

### strain EVB-1 13-19 is 

### the DCth'C ingredient (a.i.) in the manufocturing 

### usc product: Bioprot<c Technical"' which 

### can be formuloted into end-use Page 7 ofl4products for food and non-food commercial and residential uses outdoOrs. •**in~** and forests. Since the proposed appli<atiom an: 

## ""J>CCCCd to**~XSUit** in contaCt ofthe o.i. \\ith foliar 

### surfa<:CS and soil, and SJifllY drift is expected to 

### occur, expooun: to tcm:strial and aquatic non·!DrgCI Ort!llllisms is possible. 

### Based on applications**cvetY ~**  10

. 10 days. , frequent CXJlOI5UI'C'l ofthe biological control agent to non-tArget organisms an: anticipated throughout the 

### season. With respect to the environmental fate of microbial pesticides containing B. thuringltn.sls, these microbes rcndily brcal<**do~'>11** in the environment under ecnain conditions : : They degrade within 48 hts (in 'itro) under UV light exposures (S), and h.m: a half-life of3.8 hrs under normal sunlit conditions [6). · A typical half-life for B. thurlnsltmls products on .foliage is 'approximately I to 4 da)'S. The microort!llllism can 

### persist for scvcral months in'soil [4), whm: certain Cry proteins may degrade

.mthin 32 da)'S. 

# " Based on the en\imrunental fate characteristics of • B. thurlngltMis microbes, the Agency used predictive models to estirruuc potcnliaiiC\'Cls :ofexposure to DOO-Ialllet Ort!llllisms using proposed ma.dmum application llllcs. 

### , Based on these models. the Agency estimates maximum tcm:strial environmental concentrations (E<':s)

.of.2.3 

### x 1010 efu Bacillus thurlngltnsls subspecies kumakl strain EVB 113-19 /mL

. · for exposures in 

### aquatic environments. the Agency estimates a ma.,imum EC of

### 7.7 

### x 10' Bacillus thuringltmls subspecies kuntaki strain EVB 113-19 cl'ulmL based on direct application to a 6-inch body ofwater (similar to the depth ofa wetland) at the ma.,imum applica tion rote. 

### 3.l.J Terrestrial Anltuols 

### and Plants



# ... Bird.< and Mammal• Birds ond mammals may be exposed to applications of.&id/lusthurlfiR/tmls subspecies kunfulii stroin EVB 113-19 primarily through ingestion orcontact \\ith treated 

### surfaces. The Agency n:vie"'Cd the**a~lable** ecotoxicity data and has determined thatthm: is no 

### evidence of toxicity · to birds or mammals. Based on this determination, the Agency does liCit anticipate 

### ndVC'ISe effects to non-!DrgCI birds and mammals. · Non.tarxetlnstcts ·• •. '· Given thai Bacillus thurlngitllfls subspecies kuntakl strain EVB 113·19 isan insecticide, frequent CXJlOI5UI'C'l (i.e., appliCIItiOn intcn'llls of C\'Cry S to 10 days) tO \\i)d populations of. non• target insects rru>y reoso04bly be expected 10 have 

### some od•· erse effects 10 certain species. The Agency <CviC\\'Cd

.. 

# ,..,m) non-tasget insect toxicity studies to assess hazatd potential. Two ofthese studies \\'CrC conducted on 8lttD**~g** lAMie and ladybird beetle adults using the ln4liUftlCiuring 

### use product, Oioprotec Technical"'. Another older study (MRID 41443410) conducted on predatory mites using 

### a «lated Slnlin, B. thurlnslen.sl• subspecies kuntakl Stroin HD- 1,

..... also n:vie"'Cd· · The**~XSUIIs** of..Ch of these studies indiCBte sOme nd\·mc: effect.s as anticipoted given the target pests and mode'ofaction otthis pesticide. However the results of PAge 8ofl4• these studies could not be n:lied on for use in a quantillllive risk assessment due co sbortcominss in study design and execucion. The Agency also n:\icw<d risk assessments conducted for che 1998 

### Bacillus thuringlensls Rogistmtion Eligibility Doeument1811hat· indieated lhat 

### B. thurlngiensis subspecies 

### kuntalci strains displaj·ed the grutcst activity ogoinst Lcpidopltrllll species lind limited activity agalnsc Coleoptu.m ond Onhopteran species. Then:fon:. some din:ctcd coxici!y could be 

### c.• peeled 10

. susceptible immatun: J..cpidoplcrnn.IIJld to a lesser**~nt.** Coleopltrlllland Orthoptaan insects. ' These finding 

### an: consistent "ith the observalions from the studios submiued in support of 

### Bacillus**thuringl~nslisubspeeios** 

### kursta/ci strain EVB 113·19. Using a weight-of·the-evidenee approach. the informalion on n:laced strains and the informacion provid<d by the studios submiued for 

### 8acillus thurlnglenns subspecies 

### kursra/ci strain EVB-11 3·19 are considen:d sufficiencto characterize the po!ential risks co these**suscep~iblc** non-tarliel insects. The RED also noced that. even among mc · suscepliblc non·Wgct 

### insect populations lhat may be odvmely affected. n:covery lilkcs place soon after Cessation ofpesticide U$C 

## lSI 

## ' ' The Agency also n:vi""ed a submined honeybee study using 

### Bacillus rhur/nglensls subspecies 

### kurstalci suuin 

### EVB·IJJ./9. This study provides inconelusi'" n:sults since monality was ohscned in the ncgalive control and oil tn:aunenc groups IIJ1d no corn:llition ' could be drawn bci\\'CCD bee dwhs and exposure conccn!rations. However, the Agency also n:vi...,ed honeybee cesting conduc!<d on a n:llltcd strain, 

### Boc/1/us thurlngltnsls subspecies 

### kurstald strain BMP 123 (MRID No. 434917.02), \\hich demonstrated no significant effects a! 

### lOX the field rate. Based on this data 

### and given lhat n:lated n:gistcrcd strains of

### Bacillus thur/ngltnsis subspecies 

### kursta/ci are not known !o affect honeybees, adverse effects co honeybees as a resul! of exposure 10 

### Boclllus rhurlngltruls subspecies 

### kurstalci strain EVB-113·19 are not anticipated. Other non-wgct insect species are also not expected 10 be 0<1\Trscly impac!ed by 

### Bacillus thurlngltruis subspecies 

### kurstalci !!tnlin 

### EI'Bl/IJ./9 gi\,. the mode ofoction ofthe pesticide IIJ1d the low potential for 

### odvme effec!S sbo\\n in the Daphnia Magna study (sec below). Much ofthe toxicity observ<d for other Bocillus thuringiensis subspecies kwstal<i strains involves the e.xotoxins lhat may be produced during manufacturing. Dophn!a magna 

### oie considen:d co be especially semt!i\'Cio this typo oftoxin. •



# . Non-targtt Plants Advme effects are not anticipoted to populations of non·tAtget plants as a result ofCO}ltmeteial uses ofproducts containing 

### Bocl//u.s thuringitnns subspecics · kJJ.rstald strain EVB-1 I 3·19. 

### Bocillus thurlngi•nsls and i!S subspecies are not considered pathogenic to plants. E.•isting ' data from the open lite111uic 

### was c<insiden:d sufficient to satufy the conditional n:quin:ment for Non· W&<t Plant Studies, Tier I.

Pagc9of14**3.2.2. Aquatl~**  Aalmals aad Pllats • fn.rrhwqltr Fl.<th and tnurtthrqtts



# .. '', I • i J /Jor:/1/w thuringitns/s subspecies kursraki sttnin EVB 1 I 13·19 is dc:tcnnincd pnoctically non-toxic to freshwater fish for shon 1crm exposures bescd on no toxic**etT~IS** being observed at tbc highest dose tested in tbc submined toxicity Sllldy. • Based on this dc:tcnnination, the Agcacy does not1111ticipate adverse ctTc:c:t.s to non-largct freshwater fish. The toxicity Sllldy for aquatic in•·cnebra tes using

.Daphnia Magna is considered critical since much of the toxicity obsen...t

. for otbcr Bor:lllw thurlngltmis subspecies kurstaki strains involves the oxotoxins that may be produced during manufocturing. Daphnia magna arc: considered to be especlolly sensitive to 

### this type oftoxin so : thatassessing 

### riW bescd on this species could be considered worst-case. ,This Sllldy indicated that ad\'CfSC efT tell arc not likely due to infectivity or pathogenicity of. the test material. Mor141ity was observed at 10 days at \'CfY high test concentrations(> 5.7" to'cfulmL). The 21-day LD,. values was dotcnnincd to be gte11tcrthan 1.4 x· I0 6 cfulmL Bor:illw thurlnglmslssubspccies kurstaki stnlin EVB-113·19. The OS1imated aquatic environmental conCentration of7,7 X · l<>' Bor:illus thurlngltnsls subspecies kurstaki stnlin EVB 113 ·19

. cfulmL is significantly lowerthlln the 21-day 

# t.o,.,
. Thcrcfo,.,, tbc Agency does not anticipate 

### risks of concern for aquatic in'ocncbmtes

.



## . Marintlf.<war/ac fish 

### and lawltbralts



## .... Testing conducted on other Bacillus thurlngltnsls subspecies kurstaki stnlins, sho\\'Cd mini mol toxicity to 

### grass shrimp, shccpshead mlMow and copepods and indicated no adverse etTCCIS to these organisms [8). Gi\'Cn these results and the EEC for freshwntcr of7.7 x to' cfuimt. ; no advCf5C ctTccts arc 11nticipoted for marine/estuarine fish and invertebrates since oxposure to estuarine 

### and marine environments

. would be limited to spD1y

.drift or soil mobility and exposure is not expected to
.be significant in these environments. • 

## ' Additional data an: a\'lliloble to suppon this conclusion. Testing conduc:ted \\ith other Bor:lflus thuringltnsls subspecies stnlins, sho\\'Cd minimal toxicity to 

### grass sltJ:imp, shccpshcad minnow and eopepods indicated that ad\'Crsc: etTCCIS ""' not anticipoted for these organisms. Aquotk Nqnl.-r



# . AdvCf5C eiTCCIS ore not110ticipated to
. populations of oquatic plants 115 a result ofcommcrcW uses ofproducts containing Bacillus thurlngltnsls subspecies kursta.lri straln• EVB-113-19. As discussed abo\'C, Bpclllus thuringlensis subspecies kurstaki sttnin EVB-113·19 is notrolated to kno\\n plant pathogens. ' 3.2.3 Ecologi<ol Risk CoadiiSions EPA 

### hils deaennined that no adverse etTtets are anticiJ"IIed for non-largct mammals, birds, terrestrial and aquotic plants, froshwater and marinclcstuarinewlimols. and non·largc:t instets outside of the Orders Lepidoptera, Coleoptera, and Onhoptcra. Additionolly. a "No EtTect" Page 10ofl4

### dc:tormination is made for direct and 

### indirect eff<ets to fedomlly listed ("listed") endangered and threatened species ofthese 

### taxa ; and 

### for their designAted aitiCAI hAbiuu. Pr=ntly, the Agency ha.s 

### eonccms for cmain iii5CCI species in the order ofLepidoptera. and 

### to some degree insects in the 

### orders of**Coleop~ra** and 

### Orthopteru. which hAve lowe r sensitivity to /Joel/Ius tlrurlngitnsis subspeoieslcurslakl 

### compAred to lepidopterans. As 

### desaibod above, the presence 

### ofBacillus tlrurlngltm/s 

### subspecies**~takl** 

### in the 

### em-ironment is expected to be

.shon l ived; therefore, significimtlong-term effects on pop . ulations ofnon-listed insects of these orders is not**anticipo~** 

### following an application. Repeat applications would increase the 

### pottntial for effects, but these would also be inllucncod

. by**co~ oftlic**  Bacillus thuringionsis 

### subspecies lcursrold 

### \\ith relevant food sources. l ife stage exposed, and environmental factors oft'ecting persistence. It is imponantto note thai Bacillus thurlngloruis 

### subspecies leurs/old 

### must be consumed to hAve insecticidalefftct. lllercfore :insects must OO\'e consumed or ingested trcaled food sources to be at risk. Mere contact "'iih the 

### pesticide is not expected to cause effects. While the 

### risk ofoovcrsc effects ofBacillus thurlngltruiJ 

### subspecies lcurstald 

### to non-listed insects in these orders is not non-<xisttnt. is**expec~** 

### to be rclad\·ely low, panicularly considering its relative specificity. Howe''"· eff<ets on listed iridividuals \\ilhin the 

### orders oflepidoptorn. Coleoptera. and Onhoptera cannot
.be preclude<( 

## .1nd ooditional analysis would be needed to make funher determination at that level. ' ' 

# . .


# . A list ofregistered altcmati,·es to products eopt.a!!'lng Bacillus thurlngltmiJ 

### subspecies bintakl 

### is provided below in the Alternatives sec1ion**~** 

### (fable' I). This list includes conventional and biochemiCAl pesticides that ore !Jlbeled for tbe 

# some use sites and 

### insect pests
..

### end use il<Oducts containing Bacillus thurlngltnsls 

### subsj,ecieslcursrtikl EVB-113-19 aeconling to EPA's OPPIN d:llllbclse

. lnsecl hazard 

### likely differs bc:1Y>....i JJ( ldllus ' thurlngitmls 

### subspecies lcur$lakl 

### EVB· 113 ·19 and these 

### altcm.:!li\'CS. However ; insect hamrci'Cndpoints between chemiCAl pcsticides and 

### \iable or li,ing microbial pesticides are noi comparable. primarily because they are typiCAlly expressed in different units 

### (i.e.. mglmL vs cfu'lmL) and specific volumes or masses of microbial pesticides Y>ill not necessarily contain D 

### consistent number ofcells or colony forming units or • eonsistentlcvels ofpesticidal toxins (ifproduced). One ·consideration thai may be mooe eoncerrting environmental hazard and risk 

### is the 

### breadth ofthe 

### activity spectrum. For c.•ample.**Ba~illus** thurlngltmls 

### subspecies kurstakl 

### EVB-113-19 may adversely affect insects in Order Lepidoptcm, and 

### to a lesser c.xtent insects 

### in Orders C!'leoptera and 

### Onbopt<tu. Howc:\W , ' several pesticides listed below, including other microbial pesticides, are known to hA\·e od'·ersc eft'ects to a wider spectrum 

### ofinsect species and 

### may be considered to have greater relative hazard 

### to this group**ofnon·~Ar~:Ct** 

### organisms. r · • ' · 

### 4. Alternatives •. The use ofthis microbial insecticide could reduce the · usc ofconventional insecticides in commercial agriculture, foreruy and residential gardening. A li5t ofregistered alternoti\'CS to products eonmining /Jo<il/us thurlngl tnsls 

### subspecies lcurstakl 

### is provided below (fable 3). This list inc l udes eonvtntlonal and 

### biochemical pesticides thai ore !Jlbeled for the 

### same usc sites and 

### insect pests 

### os .cnd usc produets containing Baclllus.thurlnglt/U/s subspecieslcurstakl 

### EVB-113· 19 nccording 10 EPA's PPPJN d:lmbclse.

• 

### Page II ofl4Table 1

. Rcgistcml oltemath ·es ofproductS containing 

### Boclllus thurlnglmsls subsp<t:its /au: I EV/J./1

### J I fi I fl bol cd ' 'Siaki stro n
- 9 or conlrO o 

### a m.scct posts Pestlcldc Classlfo<atloa Accollate llate



# - Azadirachtin Biooh<micol 

### • /Houwuia bass/ana 

## ' M i ttobW • 

### Bacillus thurlnglrns/$ subspecies MittobW 

### " olrowol •• 

### •• 

# .. Bifrnlluin 

## ,, idlmitioidc • • CaPSaicin • · aioohomiool 

## c I Olrblunate 

# .. Chlom,'l'ifos 

### ' I**Pyridin~** 

### . • hOSPllate 

### Chromoboct<rlum subtsligoe • M i crobial 

### . Struin PRAA4-I ' 1 ' • 

# - ' 

### I tvi lulhrin ' i d Dehlll11e1hrin id Difrnocotw!ole Dioxollln;**triozinc:~ <>_xy** **_** E

n

dosulfan l orinc Cis-7

. 8 -cooxv-2-methvlooladeoanc Bloobcm i ool Esfenwlera te '· 

## . I I'}TO!hroid FJu,'llli nate P\TO!hroid ' lmldaoloprid Chlorine; imine; pyridine Lambda-cvholo lluin P\TO!hroid MalJithion te Nolcd te
. ' 

## • Pcrmelluin I P.)TO!hroid • ' Pbenolhrin I J'}'J'Othroid

- Phosmet • 

# . . 0 • spllate 

### I**~Tethrins** p TO!hroi d Biooll elluin 

# '. id ' 

# .. • .'. Tebucotw!ole

. 

## '"'" 

# . Triaz.ole •


### . ' 

### • • 

### ·•· •, • • 

### 5. Benefits and 

### Pu bli e Commen ts Biopcstioides are pest icides dcri\ • cd from such natural materials 

### as animals, plants, bocterio, and certain minerals

. Microbial pesticides, a class ofbiopesticidcs, consist o f a m ic:toorgonism (e

.g .• bacterium. fungus. viNS; orprolozoon) as lhcacti' -e ingredirnt and may have !h e follo

.. ing bone fits: 1 , ...
., 

# .. •' •' • Usually are inhcrrntly less harmfullhDJ1 convent i ona l pestlcldcs. • • G en erally effect only the lalget pest and closely' rel a ted orsanisms, 

### in contrust to 

### broad· ' speruum con,•entionol pesticides !hat may effect many diiTeicnt organiSms (e.g., 

### blnls. insects, and mammals)

. Pagc12 of l4• Often effective in vr:ry small q1W1tities and often**dccom~** quickly, thmby resulting in lower exposures and largely avoiding the pollution problems caused by conventional pesticides. • C1111 gJeO!ly**dec~** the use ofcom'tntional pestieides

. whilc crop yields**rm~ain** high, when used 

### as a component ofintegroled pest maJllll!emcnt programs. • ClUI ofTer11110ther tool for pest management in 

### areas where pesticide n:sistance, niche markets, emironmental concelns. 

### Gnd organic prcference limit the use ofconventional pesticides. Like other microbial pesticides, 

### Bocil/11$/huringitnsis subspecies 

### ' kurstati strain EVB 113-19 aligns with the potential benefits above 

### as it exhibits little to 

### no toxicity or irritation, is not pathogenic or infective to n<>D-targc:t org!lllisms, is specific to certain insect species, and could fill panicular needs in unique markets. · In the Fed<tal Rc:gistcrorJuly 20,2015180 FR 42802), the EPA announccd

. reccipt ofthe application to register a pesticide product containing a riew acti\•e ingredient for manufaciUring 1 use. The EPA opened a 30-day public commc:lit 

### period piirsuant'to the provisions ofFIFRA section 3(c)(4). Following this publication, the Agency received 

### no public comments. ' 

### ' Because AEF Global's pesticide productopplication in,·oh·es a new active**ingredicn~** 

### as well 

### as this oc:tive ingredient's first food use:s, the EPA is opening a IS-day public comment period. The EPA is taking this Oc:tion in aecordllllec with a policy, first implemented in Oc:tobcr 

### 2009, " designed to pro,ide a morc mcaningful ' opponunity for the public to paiticipate in major registration actions.

., 

### 6. Proposed Regulatory Decision 

## ' The 

### Bac/1/w thurlngirruls subspecies 

### kurstakl strain EVB ' 113-19 database 

### is comprised of studies and information that meet the data requirements for and support the labeled uses of 

### Bacillus thurlnglrruis subspecieslnmtakl strain EVB 113·19. In considering the assessed risk to**hum~~~~** heallh and the**environmen~** the EPA conchldes tho! 

### Baclilw thurlnglrruls subspecies 

### kurstal:i stmin EVB 113-19 meets the regulatory 

### Slandard under the Federallnsccticidc. Fungicide, and Rodenticide Act (FIFRA). Thcn:forc. the EPA is granting the unconditional registration ofthe 

### Bacillus ihUringitnsfs subspecies 'lnmtoti stmin EVB 

### f 13·19 perucidc product 

### und<t FIFRA section 3(eXS). ' Additionally. EPA concludes ihot there is ·a =sonab!c certainty thot no 

### harm \\ill result to the U.S. population, including' infants and children; from aggrc:gDle exp(>surc to residues of

### Bacillus thurlngltnsls subspecies 

### kurstalci stmin EVB 113-19. The EPA does not expcct, dictmy (food and drinking water) or other non-occupational risks from use ofthis microbial

### ~icidc 

## as" an active ingredient in the pesticide product.**~!though** ...Cposurc to 

### Bacillus thuringltnsls subspecies hmtati strain EVB 113-19 through consumed food and drinking v.uter is' possible; the EPA anticipates these types ofexposures based on supporting to><ieologio;allnfonnation will not result in 

# od'"""' cfTcets. In addition; the Agency has determined thot 

### Bacillus thuringi<nsis subspecies 

### kurstakl stmin EVB 113-19 is co\'CI'ed by the existing exempcion

.from the requirement ofa Page 13 ofl-1

### toleran<c for moiducs ofBacillus thurlngltnsLr 

### on all cgricull1lnll commodities. 40 CFR Part· 180.1011. One pesticide monufacturing-usc product 

# ,..;u be**rcgi>~ered,** 

### Bioprolec Technical, containing lhe sole 

### active ingredient, Bacillus tlrurlngltnsls 

### subspecies lwrstalri stmin 

### EVB 113-19. This 

### product is a technical gmdc 

### actJ,·c ingredient/manufacturing**~** 

### product (TGAIIMUP)



### . that= be formulated into insecticidal products for 

### use 011 

### food and 

### non-food 

### crops. The risk assessments supporting this 

### decision 

### can be 

### found in the 

### associated regulatory dockets (=n:b 

### for**~EPA· HQ·OPP** **201S-0419"** 

### ct ""'l" ,f(S:IIIIJ!Inn.t.S:O>'). 

### 7. References

l •. 

### de Mangel. R.A.• A. Bravo, and N. 

### Criclcmon:. How Bacillus t/rurlngltnsis bas 

### evoh"Cd specific toxins to coloniz.o tbc 

## inSect world. TrenCls in GCnetics 17{4):193 ·199

. hnp :l/iis.tn:nds.com 2. 

### Gagliardi, J

. and 

### J.Kougb.2016. Memorandum to M.Mendelsohn. Bacillus thuringitnsls 

### subspecies !wrJtalri 

### strain EVJ'I-113·19, Jcnucry 

### 12.2016. 

### 3. Konecka. 

### E., A. Kaznowski, J. 

### Zimuucka. K.

### zi~icki. 2007. Moleculor and 

### phenotypic cbaractcri7Jition ofBaCillus thurinliitnsls 

### isOlated during epizoOtics in Cydia pomondia 

### L. 

### Jo=l of lnvenebratc Pathology 94:S6-63. · • 4. 

### Melin. B.E. and 

### E.M. Cozzi. 1990. Safety to non·targtt in,·enebrutesofLcpidopte11111 strains uf

. Bacillus thurlngftnsls 

### and their 11-cxoto><ins. Pp. l49-l6iln Laird, 

### M. 

### Lacey, L.A. & 

### J>a,idson. E. W.O., Eds., Sa/tty of Mlcrob/al/nswlcldu • .

### CRC Press, lloal 

### Raton. S. 

### Mynsnik, M " R.Manashcrob, 

### E.Ben-Dov, A.Zaruky, 

### Y.MIUl!lllilh, Z.&rak. 2001. Comporntivc Sensitivity to UV-B Wation oft"'.O Bacillus thurlngltnsls 

### Subspecies and 

### oibcr Bacillus 

### sp. Cum:nt Microliiol: (43):140-143.

. '"I I. \,, 6. 

### U.S.D.A.

. Extonsion

. ServJce,**N~!~ional Agricult~**  

### Pest!ci<l;e Impact**~c nt**  

### Program. 1994. As 

### cited in EXTOXNET. 

### Pesticide Information**Profile- &tillusThurin~onsis.**  

### 7. United**Sw~** 

### Environmental Prot

. ection 

### As"'!cy·

.(290J')

. .**oP.<';Sticidcs ~egi:stn>tion**  

### Action**Documen~** 

### Bac/1/w thurl]tgitnsls 

### Vip3AA20 Insecticidal**P~ltin** 

### an4,1he Ge!'<(iC Mat«!AJ Necessary for Its**P~ut1ion** 

### (>1a

. Eicm<ntso.fVector pNOVI300) in 

### Event M IRI62 Mlliu 

### (DECO Unique Identifier:**SYN·I~\62-4)** PC Code: 006S99



# . 8. United

.States En\"ironmental Prot<!=lion Agency 

### (1998). RcregiJtmtion Eligibility Decision Bacillus thurlngfens_Lr,**EPA738·R~98:004,** 

### ,, • hup;//M\wJ.eoo.lt()vlpcst icidesls:hrm

. sc;ysWn:g !K tion.<lmsgisnuionlrol PC.Q06400 30- 

### Mar-'IS.odf

. 

### Page J4ofl4