Stud y Titl e

Toleranc e Exemptio n Petitio n fo r Autograph acalifornic amultipl e nucleopolyhedroviru s (AcMNPV) , strain F V #11 , I n o r O n Al l Ra w an dProcesse dAgricultura l Commoditie s Whe n Use dO n Crop s I n Accordanc e Wit hGoo dAgricultura l Practice s

Dat aRequiremen t Non e
Completio n Dat e October 29 , 201 3
Autho r SciReg , Inc
. 1273 3 Director' s Loo p Woodbridge,VA2219 2
Sponso r Andermat t Biocontro l A G Stahlermatten 6 CH-614 6 Grossdietwi l Switzerlan d

Pag e 1 o f 1 1

### N O CLAI M O FCONFIDENTIALIT Y

N o clai mo f

confidentiality , o n an y basi s whatsoever , i s mad e fo r an y informatio n containe di n thi s document
. I acknowledg e that informatio n no t

designate da s withi n th e scop e o f FIFR A sec . 10(d)(l)(A) , (B) , o r (C ) an dwhic hpertain s t o aregistere do r previousl y registere dpesticid e i s no t entitle dt o confidentia l treatmen t an dma y b e release dt o th e public , subjec t t o th e provision s regardin g disclosur e t o multinationa l entitie s unde r

FIFR A 10(g)
. Submitter : 'WAAj W-p^^T^C ^ Date : Z

Patrici aBiggi o Agen t (SciReg , Inc.) * *SciReg , Inc
. i s th e authorize dagen t fo r Andermat t Biocontro l A G

• • •• • • • • •



### Pag e 2 o f 1 1TABLE O FCONTENT S

STATEMEN T O FN O DAT A CONFIDENTIALIT Y CLAIM S 2 TABL E O FCONTENT S 3 INTRODUCTIO N 4 PRODUC T NAM E AN D PROPOSE D US E PRACTICE S 4 PRODUC T IDENTITY/CHEMISTR Y 4 TOXICOLIGA LPROFIL E 5 AGGREGAT E EXPOSUR E 8 CUMULATIV E EXPOSUR E 9 SAFET Y DETERMINATIO N 9 EFFECT S O N TH E IMMUN E AN D ENDOCRIN E SYSTEM S 1 0 EXISTIN GTOLERANCE S 1 0 INTERNATIONA LTOLERANCE S 1 0 SUMMARY/CONCLUSIO N 1 0

4 4

• !

Pag e 3 o f 1 1INTRODUCTIO N



### SciReg , Inc. , 1273 3 Director' s Loop , Woodbridge , VA , 22192 , o n behal f o f Andermatt Biocontro l AG , Stahlermatten 6 , CH-614 6 Grossdietwil , Switzerland , i s proposing , pursuan t t o sectio n 408(d ) o f

th e Federa l Food , Drug , an dCosmeti c Ac t (FFDCA) , 2 1 U.S.C
. 346a , t o establis ha n exemptio n fro mth e requiremen t o f atoleranc e fo r

th e microbia l activ e ingredient , Autograph acalifornic amultipl e nucleopolyhedroviru s (AcMNPV) , strai n F V #11 , applie di n o r

o n al l ra w agricultura l commoditie s i n accordanc e wit hgoo d agricultura l practices
. SciReg , Inc. , o n behal f

o f Andermat

t Biocontro l AG , i s submittin g th e followin g information , data , an dargument s i n support o f thei r petition
. AcMNPV , strai n F V #11 , i s bein g submitte dfo r registratio n a s ane w activ e ingredien t i n th e end-us e product , Loopex , fo r contro l o f cabbag e loope r

larva e (Trichoplusi ani ) o n col e crops , gree n leaf

y vegetables , celery , beans , peas , peppers , cucumbers , tomatoes , peppers , melons , ornamentals , an dflowers
.

PRODUC T NAM E AN D PROPOSE D US E PRACTICE S 

### Loope x wil l b e applie dpre-harves t i n greenhouse s an dope n field s t o col e crops , gree n leaf y vegetables , celery , beans , peas , peppers , cucumbers , tomatoes , peppers , melons , ornamentals , an dflower s t o protec t thes e crop s agains t

infestatio n cause db y cabbag e looper larva e (Trichoplusi ani)
. Applicatio n rate s ar e projecte dt o b e u p t o 5 flui d ounces/acre/application
. PRODUC T IDENTITY/CHEMISTR Y 

### Identity : Autograph acalifornic aMNP V strai n F V #1 1 

### Physical/Chemica l Propertie s Propert y Resul t Referenc e Colo r Ligh t mediu mbrow n Sylva r Technologies , In c Report , Loopex ; Autograph acalifornic a multipl e nuclepolyhedroviru s (AcMNPV ) F V #11 , batc h# 6 Physica l Propertie s Physica l state Liqui d Sylva r Technologies , In c Report , Loopex ; Autograph acalifornic a multipl e nuclepolyhedroviru s (AcMNPV ) F V #11 , batc h# 6 Physica l Propertie s Odo r Undetectabl e Sylva r Technologies , In c Report , Loopex ; Autograph acalifornic a multipl e nuclepolyhedroviru s (AcMNPV ) F V #11 , batc h# 6 Physica l Propertie s 

### Pag e 4 o f 1 1Density

p H Viscosit y 1.154g/ml(9.6 3 Ibs/gal )

6.3 1 12.64cStat20°C
. 5.86cStat40°C
. Stillmeado w Produc t Chemistr y Report , Stud y No
. 17287-1 3 Stillmeado w Produc t

Chemistr y Report , Stud y No
. 17287-1 3 Stillmeado w Produc t

Chemistr y Report , Stud y No
. 17287-1 3 Magnitud e o f

Residu e an dMetho dt o Determin e th e Residue : N o magnitud e o f

residu e (MOR ) studie s hav e bee n conducte dwith Autograph acalifornic a MNP V strain F V #1 1 base do n th e lo w toxicit y o f th e activ e ingredien t

(se e Toxicologica l Profile , page s 6-12 ) an datota l absenc e o f an y know n infection s t o organism s othe r tha n anarro w rang e o f

Lepidoptera n insects
. OPPT S Guidelin e 885.2000 , sectio n f , Backgroun dfo r

Residu e Analysi s o f

Microbia l Pes t

Contro l Agent s (MCPA) , states : "The Agenc y evaluate s residu e dat afo r MCPA s use do n food , feed , o r ra w agricultura l commoditie s onl y i f toxi c o r othe r harmfu l propertie s wer e observe d i n th e maximu mhazardtoxicolog y test s (Tie r I ) prescribe di n toxicolog y tes t guideline s OPPT S 885.305 0 throug h 885.365 0 o f thi s series
. I f

Tie r I toxicolog y test s indicat e n o toxi c o r

othe r harmfu l properties , the n n o residu e dat a(with th e general exceptio n o f

amonitorin g method ) woul db e indicate dan dthu s a recommendatio n fo r

a n exemptio n fro mth e requirement s o f atoleranc e ca n b e made. " SciReg , Inc. , o n behal f

o f Andermatt , i s submittin g apetitio n t o establis h an exemptio n fro mth e requiremen t

o f atoleranc e and , therefore , a n analytica l metho di s no t required
. TOXICOLIGA L PROFIL E Th e ful l report s tha t

support thi s petitio n an dwhic h ar e summarize di n thi s sectio n wer e previousl y submitte dto , hav e bee n reviewe dan daccepte db y th e Agency , ar e cite d herei n i n support

o f th e registratio n o f

anothe r similar baculoviru s product , Gusano , EP A Reg
. No
. 70051-43
. Andermatt

Biocontro l A G relie do n toxicity/pathogenicit y dat acite dfro mvariou s source s o f publi c literature
. Base do n th e dat asubmitte dan dcited , i t i s establishe dtha t Autograph acalifornic aMNPV strain F V #1 1 i s neithe r toxic , no r

pathogeni c t o mammals , birds , fish , aquati c invertebrates , plants , an dnearl y al l non-Lepidopteran insects
. Acut e Ora l Toxicity/Pathogenicity : Study 1 (MRID 74175) : Twenty mal e an d2 0 femal e Sprague-Dawle y rat s wer e dose d pe r o s with Autograph acalifornic aMNP V at arat e o f 4.3 5 x 10 7 occlusio n bodie s pe r rat . Tes t animal s exhibite dbod y temperatures , mea n bod y weights , an dfoo dconsumptio n simila r t o that o f th e controls
. Fou r

animal s o f

eac h se x were sacrifice do n th e followin g days : 0 , 3 , 7,14 , an d21
. Hematologica l an dbloo dchemistry result s appeare dt o b e Pag e 5 o f 1 1

### withi n norma l limits
. Histopathologica l examinatio n reveale dn o microorganis mrelate d

lesions
. There were n o death s an dal l animal s appeare dnorma l throughou t th e entir e study
. I t wa s conclude dthat

A
. californic aMNP V wa s no t injuriou s t o rats . Study 2 (MR1 D 43912201) : A s cite dper th e Nationa l Pesticid e Informatio n Retrieva l System
. * 

### Acut e Derma l Toxicity : Study 1(MRI

D 72638) : Fiv e mal e an dfiv e femal e albin o guine apig s wer e treate dwit ha singl e derma l applicatio n o f 0. 4 mLo f

suspende docclusio n bodie s (4.3 5 x 10 7 

### occlusio n bodie s per rat. ) o n thei r

shave dbacks
. Dose s o f

0. 1 mL were applie dt o 2 abrade darea s an d2 area s o f

intac t ski n o n eac hanimal
. Ther e wer e n o death s an dal l A
. californic a MNPV-treate danimal s appeare dnorma l throughou t th e entir e study
. I t

wa s conclude d that A
. californic awa s no t

injuriou s t o rat s an ddi dno t produc e dermal toxicity
. Stud y 2(MRI D 48624712) : A derma l toxicit y stud y wa s conducte dwithth e tes t materia l Baculoviru s heliothi s NPV
. Rhesu s monkey s were expose dt o th e organism
. Al l monkey s excep t fo r on e survive dth e stud y an dshowe dnorma l weigh t gains
. On e femal e monke y i n th e subcutaneou s injectio n grou p die do f unknow n cause s at

day 2 4 o f th e study
. On e subcutaneou s injecte dmal e ha drapi dsedimentatio n rate , elevate dlecocyte s an dreduce d lymphocyte s o n day 18 1 whic hreturne dt o norma l o n day 197
. N o tes t substance-relate d effect s were observed
.

. . 

### Acut e Pulmonar y Toxicity/Pathogenicity : Study 1 (MRID 48624712) : A n acut e pulmonar y toxicity/pathogenicit y stud y wa s conducte dwithth e tes t

materia l Baculoviru s heliothi s NPV
. Rhesu s monkey s were expose dt o th e organis mat 1 mg/k g b w (1. 2 x 1 0 PIB/k g bw) , I x weekl y fo r 2 6 weeks
. Al l monkey s excep t

fo r on e survive dth e stud y an dshowe dnorma l weigh t gains
. On e femal e monke y i n th e inhalatio n treatmen t rout e ha dlo w platele t

at day 18 1 whic h returne dt o normal
. N o tes t substance-relate deffect s were observed
. Acut e Inhalatio n Toxicity : Study 1 (MRID 74176 ) .Te

n mal e an dte n femal e Sprague-Dawle y rat s wer e expose dt o a singl e dos e o f

6 x 10 1 1 

### polyhedra l occlusio n bodie s o f AcMNP V fo r

on e hour
. Th e nomina l chambe r

concentratio n afte r

on e hou r wa s 11. 1 mg/L
. Al l animal s wer e observe d fo r mortality , sign s o f

toxicity , an dabnorma l behavio r throughou t

th e one-hou r

exposure perio dan ddail y fo r

1 4 day s followin g exposure . Bod y weights , foo dconsumption , an d orga n weight s wer e als o observed
. Inhalatio n exposur e o f rat s t o AcMNP V produce s n o injuriou s results
.
Pag e 6 o f 1 1Ey e Irritation :

Stud y 1 (MRID 72639) : A singl e applicatio n o f 0. 1 m l o f eac hth e tes t

materia l wa s administere dint o th e conjunct ! va l sa c o f th e lef t ey e o f eac ho f fiv e mal e an dfiv e femal e albin o (Ne w Zealan dWhite ) rabbit s weighin g fro m2. 1 t o 3. 3 kg
. Th e righ t ey e o f eac h rabbi t serve da s acontro l receivin g asingl e application , 0. 1 ml
. o f a0.8 % salin e solutio n containin g 2 % lactose
. Initia l fluorescei n examinatio n confirme dth e absenc e o f irritatio n an d cornea l damag e i n al l eyes . Observation s fo r injur y an dirritatio n wer e recorde da t 24 , 4 8 , an d7 2 hour s an dseve n an d1 4 days
. N o ey e irritatio n wa s observed ; th e ey e irritatio n score wa s zero . Derma l Irritation : Study 1 (MRID 74177) : Derma l irritatio n wa s assesse db y applyin g 0. 5 mL (2.1 7 x 10 7 polyhedra l occlusio n bodies ) ofAutograph acalifornic aMNP V t o intac t an dabraide d ski n o f si x Ne w Zealan dWhit e Rabbits
. Assessmen t followe dth e Draiz e system . N o dermal irritatio n wa s observe dand , therefore , th e primar y irritatio n score wa s zero . Study 2 (MRID 48624717) : A primar y derma l irritatio n stud y wa s conducte dusin g th e tes t substanc e Granupo mS C (CpGV ) containin g 2. 2 x 10 1 3 granules/L
. Th e tes t substanc e wa s applie dundilute ddermall y i n asingl e dos e o f 0. 5 mL/anima l ont o th e shave ddorso

lumbe r regio n o f 3 rabbits
. Th e applicatio n sit e wa s covere dwith apatc h an dsecure db y an occlusiv e bandage
. Afte r remova l o f

th e bandag e at

th e en do f

th e exposur e perio d( 4 h) , th e residua l tes t

substanc e wa s gentl y remove dwit h water . Observation s fo r mortality , behavior , clinica l signs , bod y weight , an dski n reaction s were made
. Durin g th e 10-da

y observatio n period , n o mortalitie s an dn o systemi c toxicit y symptom s were noted
. Behavio r

wa s unaffected
. Th e bod y weigh t gai n wa s i n th e norma l range . N o sign s o f ski n irritatio n wer e foun dafte r th e 4 h-exposur e perio d(se e Table)
. Mea n ski n irritatio n scores " o f 3 rabbit s afte r

derma l applicatio n o f

0. 5 m l Granupo m Tim e afte r

bandag e remova l 1 hou r 1 da y Furthe r dail y inspection s u p t o 1 0 day s Tes t substanc e Erythem a 0 0 0 Edem a

0 0 0 Control 2 '

Erythem a 0 0 0 Edem a

0 0 0 "accordingt o DRAIZ E (0-4 ) 2 ) shave dare aclos e t o th e exposur e are a Granupo mdoe s no t

produc e an y derma l irritatio n i n th e rabbit
. Th e lac k o f an y sign s o f irritatio n indicate s Granupo mi s Toxicit y categor y I V fo r derma l irritation
. Hypersensitivit y Incidents : N o report s o f hypersensitivit y hav e bee n associate dwith Autograph acalifornic aMNP V strai n F V #11
. •

Pag e 7 o f 1 1Cel l Culture :

Study 1 (MRI

D 1431081 : Thirty-fiv e nontarge t hos t cel l lines , 2 3 o f

huma n an d1 2 o f nonhuma n vertebrat e origin , wer e expose dt o Autograph acalifornic amultipl e nucleopolyhedrosi s viru s preparation s derive dfro mfou r differen t sources : polyhedra , hemolymph,cel l cultur e medium , an dculture dcells
. Th e viru s an dcell s wer e incubate d togethe r at tw o differen t

temperatures , 2 8 o r

37°C , fo r fou r differen t length s o f

time , 16 , 40 , 64 , o r 16 8 h , an dth e cell s wer e assaye dfo r th e presenc e o f

viru s b y aperoxidase

antiperoxidas e detectio n method
. Th e estimate dsensitivit y o f th e assa y a s routinel y conducte dwa s 0.9 8 n g o f alkali-liberate dvira l protei n an d1.9 5 n g o f budde dvira l protei n pe r

mm2
. N o evidenc e offran k replicatio n wa s obtaine di n an y o f th e 3 5 cel l line s tested , althoug h viru s uptak e appeare dt o b e quit e common . Viru s uptak e wa s confirme d i n some case s b y electro n microscopy
. Th e degre e o f viru s uptake appeare dt o b e dependen t o n cel l type , tim e an dtemperatur e o f incubation , an dvira l phenotype
. Viru s purifie dfro mpolyhedr awa s generall y take n u p mor e readil y tha n wer e th e othe r form s tested
. Stud y 2 (MRID 143109) : Autograph acalifornic amultipl e nucleopolyhedrosi s viru s (AcNPV ) wa s examine dt o determin e whethe r th e viru s o r

it s DN A coul dreplicat e and/o r persits t i n culture s o f

mammalia n cells
. Huma n HeL acell s o r primary huma n embryoni c kidne y cells , simian CV 1 cells , hamste r BHK2 1 (B3 ) cell s o r

Muntiacu s muntja k

cell s growin g i n monolaye r

culture s wer e use di n thes e studies
. Cell s were inoculate dwith AcNP V at

multiplicitie s rangin g fro m0. 1 t o 10 0 PFU/cell
. Subsequently , th e inoculate d cell s were investigate dfo r viru s productio n an dfo r

th e replicatio n an dth e persistenc e o f viral DNA
. Extract s o f

inoculate dcell s wer e als o screene dfo r th e occurrenc e o f

AcNPV

specifi c RNA
. AcNP V doe s no t multipl y i n an y o f

th e cel l line s studied
. Vira l DN A replicatio n o r

transcriptio n coul dno t

b e detecte db y blottin g an dnuclei c aci d hybridizatio n experiment s usin g nick-translated , clone dvira l probes
. Furthermore , ther e wa s no t evidenc e fo r

th e persistenc e o f

vira l DN A o r

o f fragment s o £vira l DN A i n mas s culture s o f

mammalia n cells
. Study 3 (MRID 147020) : Mammalia n cel l line s fro mChines e hamster , India n muntja c an dmous e were inoculate dwit h infectiou s supernatan t o f Autograph acalifornic a (Speyer ) multipl e nucleopolyhedrosi s viru s (AcNPV ) replicate di n Mamestr abrassicae (L. ) cel l culture s (IZD-Mb-0503)
. Ther e wa s n o advers e effec t o n cel l proliferation , no r wa s acytopathogeni c effec t (CPE ) induce di n suc h cultures
. Cytogeneti c dat aindicat e that uptake o f Ac-NPV s int o th e cytoplas mo f mammalia n cells , a s show n b y an electro n microscopi c study , induce dneithe r numerica l o r

structura l chromosom e aberration s no r sister chromati dexchang e (SCE ) events . AGGREGAT E EXPOSUR E Th e potentia l fo r

non-occupational , dietary , an dnon-dietar y exposur e t o Autograph a californic aMNPV strai n F V #1 1 b y th e genera l population , includin g infant s an dchildren , i s likel y throug h ingestio n o f treate dcrops . Pag e 8 o f 1 1

### Dietar y Exposur e

1
. Food : Dietary exposur e t o AcMNP V strain F V #1 1 shoul dno t b e o f concer n du e t o th e lo w toxicit y show n acros s th e entir e toxicologica l profil e (se e above)
. I f AcMNPV strain F V #1 1 i s ingested , non e o f th e studie s hav e indicate dan y toxicity/pathogenicit y o f

th e organis mi n mammals
. I n addition , Autograph a californic aMNP V strai n F V #1 1 doe s no t replicat e i n mammalia n cells
. 2
. Drinkin g water : AcMNP V strain F V #1 1 doe s no t pos e aris k

t o drinkin g water . Anticipate dagricultura l practic e prohibit s direc t applicatio n o f

th e end-us e produc t directl y t o water . AcMNP V strai n F V #1 1 i s no t likel y t o b e presen t

i n aquati c environment s sinc e i t

i s no t know n t o inhabi t

aquati c environments
. Non-Dietar y Exposur e 

### Non-dietary exposur e t o AcMNP V strain F V #1 1 wil l b e muc hmor e likel y throug h handlin g b y formulator s an dapplicators , bu t i n ligh t o f th e subjec t

product' s toxicologica l profile , shoul db e o f littl e concern . CUMULATIV E EXPOSUR E 

### Sectio n 408(b)(2 ) o f

th e FFDC A require s that , whe n considerin g whethe r t o establis ha n exemptio n fro matolerance , th e Agenc y conside r availabl e informatio n concernin g th e cumulativ e effect s o f

th e particular

ingredient' s residue s an dothe r substance s tha t

hav e a commo n mechanis mo f

toxicity
. Thes e consideration s includ e th e possibl e cumulativ e effect s o f suc hresidue s o n infant s an dchildren
. Autograph acalifornic aMNPV strain FV #1 1 i s effectiv e b y dissolvin g int o th e cabbag e looper larva e (Trichoplusi ani ) midgu t an dreleasin g th e occlusion-derive dvira l particle s (ODVs ) that

initiall y infec t

midgu t tissue s i n orde r

t o systematicall y infec t

an dreplicat e i n th e nucleu s o f

other tissue s withi n th e larvae
. Th e infecte dlarva e sto p eating , becom e sluggis han ddi e o f

vira l infection
. Followin g death , th e larva e melt s an dth e progen y viru s i s release di n th e surroundin g environmen t an dca n i n tur n infec t

neighborin g cabbag e loope r

larva e followin g ingestion
. Baculoviruse s co-evolve dwit han dhav e onl y bee n foun di n insects
. Baculoviruse s d o no t infec t Hymenoptera n pollinator s an dparasitoid s o r insec t predator s suc ha s prayin g manti s andladybu g beetles
. No membe r of the Baculovirida e famil y has bee n foun din vertebrate s o r

plants , an dAcMNP V doe s no t replicat e i n mammalia n cells
. Baculoviruse s d o no t affec t o r infec t fish , wildlife , humans , o r beneficia l organisms
. Thi s passiv e mod e o f actio n doe s no t

hav e acommo n chemical-base dmechanis mo f toxicit y a s can sometime s b e foun dwit htypica l organi c chemicals
. SAFET Y DETERMINATIO N U.S
. Populatio n Pag e 9 o f 1 1Autograph acalifornic aMNPV strai n F V #1 1 exhibit s lo w mammalia n toxicit y a s

demonstrate db y th e toxicologica l profile
. Whe n AcMNP V strain F V #1 1 i s use do n ra w agricultura l commoditie s i n accordanc e wit h goo dagricultura l practice , i t meet s th e reasonabl e certainty o f

n o harmrequirement
. Infant s an dChildre n I t i s believe dtha t

th e potentia l exposur e o f infant s an dchildre n t o residue s o f AcMNP V strain F V #1 1 throug h it s us e t o protec t plant s an dfrui t

agains t cabbag e loope r

larva e i s n o greate r than tha t o f th e genera l population
. Availabl e informatio n doe s no t sugges t tha t infant s an dchildre n ar e mor e susceptibl e t o th e effect s o f AcMNP V strain F V #1 1 tha n ar e adults
. EFFECT S O N TH E IMMUN E AN D ENDOCRIN E SYSTEM S Extensiv e literatur e searche s an drevie w o f Autograph acalifornic aMNPV strain FV #1 1 toxicit y dat aindicat e ther e i s n o evidenc e tha t i t i s an endocrin e disrupte r o r tha t i t ha s an y know n effec t

o n immun e system s a s AcMNP V doe s no t replicate i n mammalian cells
. EXISTIN G TOLERANCE S There ar e n o know n activ e agricultura l tolerance s o r toleranc e exemption s fo r Autograph a californic aMNP V strain F V #11
. A previou s exemptio n fro mth e requiremen t o f a toleranc e fo r

polyhedra l occlusio n bodie s o f Autograph acalifornic aMNP V (4 0 CF R 180.1125 ) wa s revoke di n Apri l 2004 , base dsolel y o n non-paymen t o f maintenanc e fee s an dbecaus e ther e wer e n o activ e FIFR A produc t registration s applicabl e t o th e exemption
. INTERNATIONA L TOLERANCE S There are n o know n internationa l tolerance s fo r Autograph acalifornic aMNP V strain F V #1 1 althoug h experimenta

l an dcommercia

l us e o f AcMNP V i s reporte dfro mCentra l Americ a (1998)
. SUMMARY/CONCLUSIO N A n end-us e materia l containin g Autograph acalifornic aMNP V strain F V #1 1 i s bein g submitte dt o EP A fo r

registration
. Loope x wil l b e applie dpre-harves t i n greenhouse s an d ope n field s t o col e crops , gree n leaf y vegetables , roo t

an dtube r vegetables , legum e vegetables , fruitin g vegetables , cucurbi t vegetables , watercress , cotton , tobacco , peanut , ornamental s an dflower s t o protec t thes e crop s agains t

infestatio n cause db y cabbag e loope r larva e (Trichoplusi ani)
. Applicatio n rate s ar e projecte dt o b e u p t o 5 flui d ounces/acre
.
Pag e 1 0 of 1 1

### Autograph acalifornic aMNPV strain F V #1 1 doe s no t replicat e i n mammalia n cells
. A s such , AcMNP V woul dno t b e considere dt o b e o f

pathologica l concern . Furthermore , th e organis mshow s n o acut e toxicit y b y th e require droute s o f exposure . Th e subjec t

Autograph acalifornic aMNP V strain F V #1 1 ha s n o potentia l aggregate exposur e throug hfoo do r

drinkin g water . Th e simple/rudimentar y mod e o f actio n o f th e organis magains t

cabbag e loope r

larva e als o preclude s an y potentia l fo r cumulativ e exposure . There i s als o n o evidenc e that th e organis maffect s th e immun e syste mo r cause s endocrin e disruption
. Whe n use di n accordanc e withgoo dagricultura l practices , Autograph acalifornic aMNP V strain F V #1 1 meet s th e reasonabl e certaint y o f n o harm requiremen t

t o th e genera l U S populatio n and , specifically , th e segmen t o f th e populatio n containin g infant s an dchildren
.

,



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