, .. ' ' 

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;iltmls $\lbspeeics /nus loki 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'oiil'*''stl.iO. in'iJic:e'niJy 1970.: Jdctiiilic:atiOn as Bacillw 

' . ' . . . . . . .. , ., thuringltmls·su!ispecies kurstakl using standanl bioel?<miea!, phmotypic ailll serologieal ~ •· 

methods. plus comparison of the ay protein_gcnes 0)' I (\a, cry 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 nn dsolatt of a microbial 

ptJI/cldt Is a ,..... act I\'<' lngrtdltnt and mwt bt rtgisttrtd indtptndt nJ/y of any Jlmllorly 

dtsll{71altd and alrtady rtgist<r<d mlcrablal ptstidtlt actl•'r lngrtdienl. 

After revit\•ing submlued and publiea!ly available data lltld infonnalion, EPA concluded that 

this new active ingredient is eovefcd 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\'C ingn:dlent Bacillus thuringitnsls 

subspecies lnustald stl'llin EVB 113-19 from AEF Glob.\~, In<:, Bioprotec Tccbnieal is atechniea! 

grade aetivc ingrediep,ll'!"'"ufncturing use product (TGAIIMUP) to bt formulnted into 

insecticidal prodUciS for 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 of a toleranee for residues of the 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 of studies 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 of studies, inchMiing Tier I,I!CutC toxicityiP"tbOgenicity (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 •>1e) <loti Tier II and Ill testhigtc,g_, subchronic ' 

toxicityi..,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 of Bocillus 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 of unintentionhl 

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 of samples. 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 

of the Bacillus thuringiensis subspecies kurstaki stmin EVB-113-19 oetivc ingmlicnt no toxicity, 

inilation, infectivity, 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 

soil nnd water associated nnd ore commonly fowid in a variety of fresh 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 of the Bac:illuslhuringicnsis tolerance exemption under 40 CFR 

I 80.1011, live batches of Bacillus thuringionsis su~es kut51Aki strAin EVB-113-19 wac 

tested using subcutaneous injection of at least J million 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 of the mice\\= noted during the obsm'lltion 

periods. Similar ncgali,•e testing is required for?."~ ermcn~ ~tcb ofBac:ill~ ,lhuringiensis 

subspecies kurstaki strain EVB-113-19 produced for formulation of any 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'deformity,llDCI' slmii.;: numbers' ofli\'C larvae at ihe en(! of the s i!Ay 

incubation ~vben dOsed with 2,105 ppm 'BacilluS_ 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 for eoriun~ial use in 

pan because it is not a kno"" ll-cxotoxin produur: 

As discUssed in the 1998 Bac:illus'ilikinS;.n..iS Re'regiSIIllti~':l. !lli811>llity DocU~t'~t. RED). 

the Agency bas no ''lllid e\idcnccto link actual usage oflllkillus thuiingiensis iiisectiCidi:s "ilh 

episodes of diarrhea f'!llowing ingestion of food llDd belleyes that.the cu~nt uses of Bacillus 

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 Conier.. 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 

Mtmorandumfroni ll'll(iamll'oodroK;to Arturo Ctiitillo) .. fn addition, a sinnmary rn•itw of 

mammalian toxicity studies l.·ai ptibllshtd 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 

thurlnglrnsu-IJDMd I'UJicidts. PUll<. Sci. 4$, 9S-JO$). To dal<.. no .bocnm mammolian Mallh 

rfftt:IS hat~ bren demonstra~rd In arry lnf<CIMI)rpalhogmlcil)t stU<f)• (Table I. Acute Mammalian 

Tax/ell)! for Bacillus thuringlrnsls). The sum total of all toxicology data submllled to thr Agency 

comp/rt< with tilt! lock of any rtpor/S of slgnljlcanJ human ht!alth hazards oftht \'orious Bacillus 

thurlnglrnsl.r strains allow the conclwlon that a/1/nfrctMI)vpalhoJ: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.r productldtnJ/1)! and nwnufocturlng 

proctss ltstlng data lndlcaltd lhtrt Is no mammalian toxicll)tassoclal<d with thr strain, In 

accordance with standard procllr:<s wht'n thtu studies art wahYJ. /alwllanguagt w/11/w 

rtqulrtd assuming a Toxicil)t Cai<Jlory of Ill. 

Tili!Wtr and Par!Jaunlcltr 

Submiued acute omltoxicityfpolhogenicity data clcmonstnlte ibol Bacillus thlllingiensis 

subspocieslcursloki 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 

toxioityfpathogenicit)' and ocutc intral'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 Bioprotec Techniall (Bacillus thlllingicnsis subspecies 

kurstllkl strain EVB-113-19 (9.9 x 10° total CFUfmL; spoRS"9.1 x 10' CFUfmL) demonstrated 

it to be not to!cic ala dose level of5000 msfKs body weight and in EPA tox!cityeaJegory IV for 

oml toxicity. 

Cited dermal toxicity data on Btu:illus thuringiensis subspecies kurstaki dcmonstnlle no toxicity 

at doses up to 4.7xl011 >Poresfks and lhils BioprotecTechnical is in EPA'toxicity Calegory IV for 

dermaltoxicity. • 

Bioprotec end-use product data demonstrated ibol it is tnlnittWiy itritatiQg to the eye. further. 40 

CFR IS82140 foelnote S states that [t)h<! 170 $0ricsSIUdies for the MP and EP are intended to 

provide data on the acute toxicity of the product. Waivm for ony or all of these stuclies may be 

aronted when the applicant can clernonstrme that the eombinotion of inert iiiSJCdicniS is not likely 

to pose any sisnifocant human be:llth rUla. Gi'-cnthe formulation of the techniall and the results 

of the end-use study,the clal4 requirement !s satisfied and Bioprotec Techniall is in EPA 

Toxkity Cftlegory Ill for C)'e irril4tion. 

Bioprotec end-IISC: produ<t clal4 demonstrated that it is minimally irril41ing to the eye and dermal 

data showed signs ofirriiAlion that subsided. Further, 40 CFR I 58.2140 footnote 5 stales that 

(t)he 870 sories stuclies for the MP and EP are intended to provide dolo 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 of inert 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< and Risk Chqrqrtuligt!on: ,There is minimal potential for Bacillus 

thurlnglrmis to enter ground water .or othet; 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 "'th Bizclflus 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 of the 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 of Bacillus lhuringl<cnsls. · ... , , ' 

Qm,pgrtonal &p9.fJ!!t: Because of a lack of mammalian 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 of14 
Agsregate ExDOS\!R from Muhiplc Routes Including Oral. Pmnal and 

Inhalation 

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 of pesticidal 

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 'chi I elton. from o'ggregate .. posurc to nesidues of Bacillus 

lhurlngltnsls subspecies kuntakl strain EVB I I 3-I 9. The EPA does not expect dietary (food and 

drinldng water) or other non-occ:upational risks from usc of this 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 of Bacillus thuringltnsls on all agricultural commoditics, 40 CFR Pan 

180.1011. 

For more information on the human health risk assessment of BocliiiL< thurlngltnsls 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 of Eeologieal Risk " ' 

In order to assess a microbial pesticide's risk to the environment. the EPA initially requires a 

"ide range of studies. 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 of studies aDd information required to suppon the asscssmonl'of risk 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 ofl4 
products 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 of the 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 of the 

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:of exposure 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 of water (similar to the depth of a wetland) at the 

ma.,imum application 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 or contact \\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 

of these 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' of action 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 of pesticide 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 of oction of the pesticide 

IIJ1d the low potential for odvme effec!S sbo\\n in the Daphnia Magna study (sec below). Much 

of the 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 of toxin. • . Non-targtt Plants 

Advme effects are not anticipoted to populations of non·tAtget plants as a result of CO}ltmeteial 

uses of products 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 EVB1I 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•·cnebrates 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 of toxin 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·I06 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 of commcrcW uses 

of products 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 of these taxa; and for their designAted aitiCAI hAbiuu. 

Pr=ntly, the Agency ha.s eonccms for cmain iii5CCI species in the order of Lepidoptera. and to 

some degree insects in the orders of Coleop~ra and Orthopteru. which hAve lower sensitivity to 

/Joel/Ius tlrurlngitnsis subspeoieslcurslakl compAred to lepidopterans. As desaibod above, the 

presence of Bacillus tlrurlngltm/s subspecies ~takl in the em-ironment is expected to be.shon 

lived; therefore, significimtlong-term effects on pop.ulations of non-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. life 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 of oovcrsc effects of Bacillus 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 of registered 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 of cells or colony forming units or • 

eonsistentlcvels of pesticidal toxins (if produced). One ·consideration thai may be mooe 

eoncerrting environmental hazard and risk is the breadth of the 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 of insect species and may be considered to have greater relative 

hazard to this group ofnon·~Ar~:Ct organisms. r · • ' · 

4. Alternatives •. 

The use of this microbial insecticide could reduce the ·usc of conventional insecticides in 

commercial agriculture, foreruy and residential gardening. A li5t of registered alternoti\'CS to 

products eonmining /Jo<il/us thurlngltnsls subspecies lcurstakl is provided below (fable 3). This 

list includes 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 ofl4 
Table 1. Rcgistcml oltemath·es of productS containing Boclllus thurlnglmsls subsp<t:its 

/au: 'Siaki stro I n EV/J./1 J -I 9 fi or conlrO I o fl a bolcd m.scct ' posts 

Pestlcldc Classlfo<atloa 

Accollate llate - Azadirachtin Biooh<micol • 

/Houwuia bass/ana ' MittobW • 

Bacillus thurlnglrns/$ subspecies MittobW " 

olrowol •• •• .. Bifrnlluin ,, idlmitioidc • • 

CaPSaicin • ·aioohomiool 

c I Olrblunate .. Chlom,'l'ifos 'I Pyridin~ . •hOSPllate 

Chromoboct<rlum subtsligoe • Microbial . 

Struin PRAA4-I '

1 ' • - ' 

I tvilulhrin ' id 

Dehlll11e1hrin id 

Difrnocotw!ole Dioxollln; triozinc:~ <>_xy_ 

Endosulfan lorinc 

Cis-7 .8-cooxv-2-methvlooladeoanc Bloobcmiool 

Esfenwlerate '· . II'}TO!hroid 

FJu,'lllinate P\TO!hroid ' lmldaoloprid Chlorine; imine; pyridine 

Lambda-cvhololluin P\TO!hroid 

MalJithion te 

Nolcd te. ' • 

Pcrmelluin I P.)TO!hroid • ' 

Pbenolhrin I J'}'J'Othroid - Phosmet • . .0 •spllate 

I ~Tethrins p TO!hroid 

Bioollelluin '. id ' .. • .'. 

T ebucotw!ole . '"'" . Triaz.ole • . 

' • • ·•· •, 

• • 5. Benefits and Publie Comments 

Biopcstioides are pesticides dcri\•cd from such natural materials as animals, plants, bocterio, and 

certain minerals. Microbial pesticides, a class ofbiopesticidcs, consist of a mic:toorgonism (e.g .• 

bacterium. fungus. viNS; orprolozoon) as lhcacti'-e ingredirnt and may have !he follo .. ing 

bone fits: 1 , ... 

., .. •' •' 

• Usually are inhcrrntly less harmfullhDJ1 conventional pestlcldcs. • 

• Generally effect only the lalget pest and closely' related orsanisms, in contrust to broad· ' 

speruum con,•entionol pesticides !hat may effect many diiTeicnt organiSms (e.g., blnls. 

insects, and mammals). 

Pagc12 ofl4 
• 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 of com'tntional pestieides.whilc crop yields rm~ain high, 

when used as a component of integroled 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 of conventional 

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 of the 

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 of the 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 of this 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 of exposures 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 of a 

Page 13 ofl-1 
toleran<c for moiducs of Bacillus 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 of BaCillus 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 ~cnt 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 MIRI62 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()vlpcsticidesls:hrm. sc;ysWn:g !Ktion.<lmsgisnuionlrol PC.Q06400 30-

Mar-'IS.odf. 

Page J4ofl4