1

**F e**  **de r**  **al F**  **oo d**  **, D r**  **u g, a**  **n d**  **Cos m**  **e t**  **ic A**  **c t**  **( FFD**  **C A)**  **Co n**  **si d**  **er a**  **t io**  **n s for**  **GS -**  **om ega/kappa**  **- Hxtx**  **- Hv1a**  **Do c**  **k e**  **t ID N**  **u m**  **be r**  **: E**  **PA -**  **HQ -**  **OPP -**  **2012 -**  **0 389** 

**Da te**  **: December**  **2 0**  **, 2 013**  S ec tion 408 (c)( 2 )( A ) ( i) o f F F D C A a llows the E P A to e st a blish an e x e mption fr om the re qui r e m e nt f or a tol eran c e ( the l e g a l limit f or a p e sti c ide c h e mi c a l r e sidue in or on a f oo d ) o n l y if the E P A d e t er min e s th at the e x e mption is “ s afe .” S ec tion 408 (c)( 2 )( A ) ( ii) of F F D C A d ef i n e s “ s a f e ” to m ean th at “ th e r e is a rea son a b l e c e rt a int y th at no h ar

m will re sult fr om a ggr e g at e e x posur e to the p e sti c ide c h e mi ca l re s i du e, in c luding a ll anti c ip at e d di e t ar y e x posure s and a ll oth e r e x posu re s f or whi c h th er e is re li a

ble i n f o r m ation.” This in c lud e s e x posur e thr ou gh dr inking w at e r an d in re sid e nti a l s e ttin g s b ut do e s not in c lude o cc u p ation a l e x posure . P ur su ant to F F D C A s ec tion 408 (c ) ( 2 ) ( B ) , in e st a blishing or m a i n t a ining in e f fec t an e x e mption fr om the re qui r e m e nt of a tol eran c e , the E P A mu s t t ake into acc ount the f a c to r s s e t f

o rth in F F D C A s ec tion 408 ( b )( 2 ) ( C ) , whi c h r e qu i r e the E P A to g i v e sp ec i a l c onsid eration to e x posur e of in fants and c hildr e n to the p e sti c ide c h e mi c a l re sid

u e in e st a blishing a tol e ran c e e x e mption, and to “e n sur e th at th er e is a r e a so n a ble cert a int y th at no h ar

m will re sult to in fants and c hildre n fr om a ggr e g at e e x posur e to the p e sti c ide c h e mi ca l re sidu e ....” Addition a l l y, FF D C A s ec tion 408 ( b ) ( 2 )( D) r e qui re s th at the E P A c onsid e r “ av a il a ble in f o r m ation c on c e r ning t he c umul ative e f

fec ts o f [ a p arti c ul ar p e sti c id e ' s] . . . re sidu e s and oth e r subst an ce s th at h ave a c ommon m e c h anism of to x i c i t y .” The E P A p erf

o r ms a numb e r of an a l ys e s to d e t e r mine the r isks fr om a g gr e g ate e x posur e to p e sti c i de re sidu e s. F i r st, the E P A d e t er

min e s the to x i c i t y o f p e sti c id e s. S ec ond, the E P A e x a min e s e x posur e to the p e sti c ide thr o u gh f ood, dr inking w at er , and thr o u gh oth e r e x posure s th at o c c ur a s a re sult of p e sti c i d e use in re sid e nti a l s e ttin g s. **I. S** **u m**  **m ary**  **of P** 

**e titio**  **n e** **d -**  **f or Tol**  **e ra**  **n c**  **e E**  **x e** **m ption**  In the F e d e r a l R e g ist e r of July 2 5, 2012 ( 77 FR 43562) (FRL - 9353 - 6), the EPA issu e d a noti c e pur s u ant to F F D C A s ec tion 408 ( d )( 3 ) , 21 U. S . C . 346 a( d )( 3 ) , announ c i ng the f ili n g of a p e sti c i d e tol eran c e p e tition ( P P 2F8014 ) by Vestaron Corporation, 4717 Campus Drive, Ste. 1200, Kalamazoo, MI4 9008 . The petition re qu e s t e d th at 40 C F R p art 180 be am e nd e d b y e st a blishing an e x e mption fr om the re qui re m e nt of a tol e r an c e f

or r e sidu es of GS - omega/kappa - Hxtx - Hv1a . The noti c e r e fere n ce d a summ ar y of th e p e tition p re p ar e d b y the p e tition er , Vestaron Corporation , whi c h is av a i l a ble in Do c k e t I D Numb e r E P A - H Q - O PP 2012 - 0 389 via http : //

www . re gulations. g

o v . **II. Toxi** **c ologi** **c al Pro** 

**f ile**  C onsist e nt with s ec tion 4 08 ( b )( 2 ) ( D) of F F D C A, t he E P A re vi e w e d the av a il a ble s c i e nti f

ic d ata and oth er re l e v ant in f

o r m ation on GS - omega/kappa - Hxtx - Hv1a , and c onsid e r e d its v a lidi t y, c ompl e t e n e ss, and re li a bili t y, a s w e ll a s the re l ationship of this in f o r m ation to hum an r isk. The E P A a lso c onsid e r e d av a il a ble in f o r m ation c on c e r

ning t he v ar i a

bili t y o f the s e ns i tiviti e s of m a jor id e nti f

i a ble sub gr oups o f c onsum er s, in c luding in fants and c hildre n. **A . O**  **ve r** **v i** **e w**  **of GS** 

**- om**  **ega/kappa -** 

**Hxtx -**  **Hv1a** The active ingredient GS - omega/kappa - Hxtx - Hv1 (VersitudeTM peptide) acts as an insecticide for use on specified ornamental plants, turf and edible crops against cabbage looper . GS - omega/kappa - Hxtx - Hv1 (Versitude TM peptide) functions primarily as a central nervous s ys tem inhibitor in insects, and is intended for use in the suppression of cabbage looper . The end use product, VST - 006330 EP, is mixed with water and2 applied as a foliar spray

with ground or aerial pest icide equipment, and it can be used in either the field or greenhouse for the suppression of cabbage looper . GS - omega/kappa - Hxtx - Hv1a, is a peptide derived from one of the toxicologically active components of Australian funnel spider ( Hadronyche versuta ) venom. It is a large molecule made up of a chain of 41 amino acids which will be produced in and isolated from yeast . Its surface is covered in hydrophilic residues, making it highly soluble in water, but insoluble in ethanol. The active ingredient GS - o mega/kappa - Hxtx - Hv1 acts as an insecticide for use on labeled ornamental plants, turf and edible crops against cabbage looper . GS omega/kappa - Hxtx - Hv1 functions primarily as a central nervous sy stem inhibitor in insects, and is intended for use in the sup pression of cabbage looper . Acute toxicity data support the registrants’ claim that GS omega/kappa - Hxtx - Hv1a acts specifically on insects and not on mammals. **B .**  **Biochem i** **cal / Microbial**  **P e** **sti c**  **ide Toxi** **c ology**  **Data R**  **e q**  **u ir** **e m**  **e n**  **ts** All a ppli ca ble m amm a li an to x i c ology d ata re qui r e m e nts suppo rting the r e qu e st f or an e x e mption fr o m the re qui re m e nt of a tol er an c e f or r e sidu e s of GS - omega/kappa - Hxtx - Hv1a i n or on a ll f ood c ommoditi e s h ave b e e n f ul f ill e d with d ata submitt e d b y the p e tition e r or d ata w a iv e r r e qu e sts that h ave b e e n gran t e d b y the E P A. The to x i c i t y t e sts ( ac ute o ra l, d er m a l, and inh a l ation to x i c i t y ) and i rr it ation t e sts (ac ute e y e and p r im ar y d er m a l i rr it a tion) th at a d dre ss pot e nti a l r out e s of e x posur e to the ac tive i n gr e di e nt ar e a ll c l a ssi f i e d in To x i c i t y C at e g o r y IV ( s e e below or Re f . 1) , with the exception of mild skin irritation (Category III) , and re v ea l e d little to no to x i c i t y attr ib u t e d to GS - omega/kappa - Hxtx - Hv1a . F in a l l y , the p e tition e r re po rt e d th at no h y p e r s e nsitivi t y in c id e nt s o cc ur r e d dur i n g the r e s earc h, d e v e lopm e nt, a nd t e sting of this active ingredient . The ov e r a ll c on c lusions f r om a ll to x i c olo g i ca l in f

o r m ation submitt e d b y the p e tition e r ar e b r i ef l y d e s cr ib e d b e low, and mo r e in - d e p th s y nops e s of stu d y r e su l ts can be f ound in the a sso c i at e d draft Biopesticides Registration Action Document ( BRAD ) for GS - omega - kappa - Hxtx - Hv1a , p r ovid e d a s a r e f e r e n c e in S ec tion VI I o f this do c um e nt ( R ef . 1 ). 1. A c ute oral tox i c ity

– rat ( Harmoni z e d Guid e li n e 870.1100; M

aste r R ec o rd I

d e ntifi c ation N

umb e r (M RI D N o. 48779 0 - 07

) ) . An a c c e pt a

ble a c ute o ra l to x i c ity stu d y d e monstrat e d th at GS - omega/kappa - Hxtx - Hv1a w a s not to x ic to fe m a le rats wh e n do s e d at 5,0 0 0 milli grams p e r kil o gr am ( m g /k g ) of bo d y w e i ght. The o ra l m e di an l e th a l dose ( LD 50 ) , whi c h is a st atisti ca l l y d e r iv e d si n g le dose t h at can be e x p ec t e d to c a use d eath in 50% of t e st an i m a ls, w a s gr e at e r th an 5 , 000 m g /k g f or fe m a le rat s ( To x i c i t y C at e g o r y IV) ( R ef . 2 ) . 2. A c ute oral tox i c it

y /pathoge ni c ity (

Harmoniz e d Guid

e line 885.3050; M

RI D N o. 487790 - 19

) . Up o n c onsid eration of r e sults of oth e r d ef initive to x i c olo g i c a l d ata submitt e d b y the p e tition er , the E P A w a iv ed ac ute o r a l to x i c i t y

/p ath o g e ni c i t y t e sti n g f

or GS - omega/kappa - Hxtx - Hv1a . The acute oral toxicity /pathogenicit y s tudy was not required because products containing GS - omega/kappa - Hxtx - Hv1 are purified . The production of this peptide in a y east does not present a hazard of infectivity or pathogenicity from the yeast itself based on information provided in the product anal ys is and manufacturing process. The final product presents no infectivity or pathogenicity

hazard since the ye ast is inactivated (or killed) during the purification process to yield the final peptide product.3 An ac ute o r a l to x i c i t y s t u d y c ondu c t e d on f e m a le r ats ( M R I

D No. 487790 - 07 ) d e monstrat e d th at GS omega/kappa - Hxtx - Hv1a w as not toxic ( L D 5 0 gr eat e r th an 5,000 m g /k g ; To x i c i t y C at e g o r y IV ) . In addition, the y east used to produce the peptide is not pathogenic, the y east is removed during the manufacturing process, and samples monitored for microbial contamination have been negative. The EPA believes these data, when taken together , indicate that this peptide would not be toxic, infective, and/or p athog e nic thr o u gh the o ra l r oute of e x posur e and th at f urth e r t e sti n g is not n ece ss ar y ( R ef . 2 ) . 3. A c ute inhalation tox i c ity

– rat ( Ha rmoniz e d Gu i d

e line 870.1300; M

RI D N o. 48779 0 - 0 9

) . An a c c e pt a

ble ac ute inh a l ation to x i c i t y stu d y d e monstrat e d th at GS - omega/kappa - Hxtx - Hv1a w a s not to x ic to m a le and fe m a le r ats wh e n e x pos e d to 2. 05 milli grams p e r l it e r ( m g / L) . The inh a l ati o n m e di an l e th a l c on c e ntr ation ( L C 50 ) , whi c h is a st atisti ca l l y d er iv e d c on ce ntr ation th at can be e x p ec t e d to ca use d e ath in 50% of t e st anim a ls, w a s gr e at e r th an 2. 05 m g / L f or fe m a le rat s, m a le rats, and both f e m a le and m a le r ats c om

b in ed ( To x i c i t y C at e g o r y IV ) ( R ef . 2 ) . 4. A c ute pulmonary tox i c it y /pathoge ni c ity (

Harm o niz e d Guid

e line 885.3150; M

RI D N o. 487790 - 19

) . Upon c onsid eration of r e sults of oth e r d ef initive to x i c olo g i c a l d ata submitt e d b y the p e tition er , the E P A w a iv ed ac ute pulmon ar y to x i c i t y

/p atho g e n i c i t y t e sti n g f

or GS - omega/kappa - Hxtx - Hv1a because products containing GS - om ega/kappa - Hxtx - Hv1 are purified and do not contain yeast . An a c ute inh a l ation to x i c i t y stu d y c ondu c t e d on rats ( M R I D No. 487790 - 0 9 ) d e monstrat e d t h at GS - omega/kappa - Hxtx - Hv1a w a s not to x ic ( L C 5 0 great e r th an 2. 05 m g

/ L ; To x i c i t y C at e g o r y IV ) . Inaddition, the y east used to produce the peptide is not pathogenic, the y east is removed during the manufacturing process, and samples monitored for microbial contamination have been negative. The EPA believes these data, when taken together , indicate that this peptide would not be toxic, infective, and/or p athog e nic thr o u gh the i nh a l ation r oute of e x posur e and th at f u rth e r t e sti n g is not n ece ss ar y ( R ef

. 2 ) . 5. A c ute inj ec tion tox i c it

y /pathoge ni c ity (

intra v e n o us)

– rat (

Ha r moniz e d G uid

e line 885.3200; M

RI D N o. 487790 - 19

) . Up o n c onsid eration of r e sults of oth e r d ef initive to x i c olo g i c a l d ata submitt e d b y the p e tition er , the E P A w a iv ed a c ute inj ec tion to x i c it y /pathogenicity

testing for GS - omega/kappa - Hxtx - Hv1a because products containing GS - omega/kappa - Hxtx - Hv1 are purified and do not contain ye ast . GS - omega/kappa Hxtx - Hv1a peptide is low in acute toxicity . The acute oral, dermal and inhalation toxicity studies conducted on GS - omega/kappa - Hxtx - Hv1a peptide all r eported no deaths at the limit dose. In addition, the yeast used to produce the peptide is not pathogenic, the ye ast is removed during the manufacturing process, and samples monitored for microbial contamination have been negative. ( R ef . 2 ) . 6. H y p e rs e nsiti v ity in c id

e nts ( Harmoniz e d Guid

e line 885.3400; M

RI D N o. 487790 - 19

) . The p e tition e r re po rt e d th at no h y

p er s e n sitivi t y in c id e nts, in c lud i ng imm e di at e - t y p e or d e l a ye d - t y

pe re a c tions of hu m ans and dom e stic anim a ls, o c c urre d d u r ing re s e ar c h, d e v e lopm e nt, or t e sti n g of GS - omega/kappa - Hxtx - Hv1a ( R ef . 2 ) . 7. A c ute d

e rmal tox i c ity

– rat (

Harmoniz e d Guid

e line 870.1200; M

RI D N o . 48779 0 - 08

) . An a cce p t able ac ute d e r m a l to x i c i t y stud y d e monstr at e d th at GS - omega/kappa - Hxtx - Hv1a w a s not to x ic to m a le and fe m a le r ats wh e n dos e d at 5,0 0 0 m g /kg o f bo d y w e i ght f

o r 24 hour s. The d er

m a l L D 5 0 w a s gr eat e r t h an 5,0 0 0 m g /k g f or fe m a le and m a le rats ( To x i c i t y C a t e g o r y IV) ( R ef . 2 ) . 8. Primary d

e rmal irritation

–rabbit (Harmoniz e d Guid e line 870.2500; M

RI D N o. 48779 0 - 11

). An acceptable primary

dermal irritation study d e mo n strat e d th at GS - omega/kappa - Hxtx - Hv1a w a s a moderate i rr it ant to the skin of ra b bits ( To x i c i t y C at e g o r y III) (Ref. 2 ).4 9 . Primary d

e rmal sensitization

– guinea pig ( Harmoniz e d Guid

e line 870.2 6 00; M

RI D N o. 48779 0 - 12 ) . An ac c e pt a ble p r im ar y d er

m a l sensitization stu d y d e mo n strat e d GS - omega/kappa - Hxtx - Hv1a to be a non sensitizing agent (To x i c i ty C at e g o r y IV) ( R ef . 2 ) . 10 . A c ute e

y e irritation

– rabbit (

Harmoniz e d Guid

e line 870.2400; M

RI D N o. 487 79 0 - 10

) . An a cce p t a

ble e ye i rr it ation stu d y d e m o nstrat e d th at GS - omega/kappa - Hxtx - Hv1a was minimally irritating to the eyes of ra bbits . No corneal opacity or iritis was observed in any treated eye during this study . However, one hour after test substance instillation, two treated eyes exhibited ‘positive’ conjunctivitis. All animals were free of ocular irritation by

48 hours ( To x i c i t y C at e g o r y IV ) ( R ef . 2 ) . **III. A**  **ggr e** 

**gate E**  **xpos u**  **r e**  In e x amining a g gr e g ate e x posure , FF D C A s e c tion 408 di rec ts the E P A to c onsid e r av a il a ble in f o r m ation c on cer ni n g e x posure s fr o m the p e sti c ide re sidue in f ood and a ll oth e r non - o cc up ation a l e x posure s, in c luding dr inki n g w at e r fr om gr ound w at e r or sur fac e w at e r and e x posur e thr ou gh p e sti c ide use in g ar d e ns, l awns, o r buildin g s ( re sid e nti a l and oth e r indoor us e s ) . Food E x posur e : E x posur e to re sidu e s of GS - omega/kappa - Hxtx - Hv1a , a 41 amino acid peptide derived from one of the toxicologically active components of Australian funnel spider ( Hadronyche versuta ) venom and isolated from yeast ( R ef

. 3 ) , in c ons u m e d f

ood is possible . GS - omega/kappa - Hx tx - Hv1a may be a ppli e d foliarly to edible pl ant s, turf and ornamentals . S in c e GS - omega/kappa - Hxtx - Hv1a is applied as a foliar insecticide to crops , it is possible th at edible f ood c ommoditi e s may

retain residues of GS - omega/kappa Hx tx - Hv1a . F urth er , t rea

t e d crops c ould be div ert e d f o r f ood or fee d pur

po s e s; th eref

o re , e x posur e to GS omega/kappa - Hxtx - Hv1a in this situ ation is a lso pl a usibl e . R e g ar dl e ss of the s ce n ar io, should GS omega/kappa - Hxtx - Hv1a be p re s e nt on f ood, suppo rting to x i c olo g i ca l d ata and product analy sis data indi cat e th at no to x i c i t y, p ath o g e ni c i t y, and/or in f e c tivi t y is lik e l y to o cc ur with an y f ood e x posur e re sulting f

r om the use of GS - omega/kappa - Hx tx - Hv1a a s a p e s ti c ide wh e n a ppli e d in acc o r d a

n c e with l a

b e l di r ec tions and g ood a gr i c ultura l p r a c ti ce s ( s e e a ddit i on a l dis c ussion in S ec tion I I of this do c um e nt ). Drin k ing W a t e r E x posu r e : Like c onsum e d f ood, e x posur e to re sidu e s of GS - omega/kappa - Hxtx - Hv1a , a 41 amino acid peptide, in consumed drinking water is anticipated to be possible but negligible. However, GS omega/kappa - Hxtx - Hv1a inter acts specificall y with the insect nervous s ys tem and does not interact with vertebrate s ys tems. The submitted and reviewed acute oral data suggest GS - omega/kappa - Hxtx - Hv1a is not toxic via the oral route (> 5,000 mg/kg). Submitted literature studies on surrogate peptide compounds indicate lack of bioavailability by mammals via the oral route (MRID 48779019). Based on the low toxicity profile of the compound and low bioavailability , exposure to this compound from treated food or residues in water is not of concern. Oth e r N on - o cc upational E

x posur e : Based on the lack of acute toxicity and pathogenicity , r esidential exposure to GS - omega/kappa - Hxtx - Hv1a is not expected to pose undue risk provided the product is applied or used in accordance with label directions . In addition, p o tential handler exposure is reduced through the requirement of personal protection equipment (PPE) on the label, including long - sleeved shirt and long pants, waterproof gloves and shoes plus socks.5 **I V**  **. Cu**  **m u**  **lati v**  **e E** 

**ffec ts**  **f rom**  **S u**  **bsta n**  **ce**

**s w**  **i t**  **h a**  **C o**  **m m**  **on M** 

**ec h**  **a n**  **i s** **m of Toxi** **c ity**  S ec tion 408 ( b )( 2 ) ( D )( v ) of F F D C A re qui r e s th at, wh e n c onsid er i n g wh e th e r to e st a blish, modi f

y, or re voke a tol eran c e , the E P A c o n sid e r “av a il a ble in f o r m at i on c on cer

ni n g the c umul ative ef

f ec ts of [ a p arti c ul ar p e sti c id e’ s] . . . re sidu e s and oth e r subst an c e s th at h ave a c ommon m ec h an i sm of to x i c i t y .” The E P A h a s not f

ound GS - omega/kappa - Hxtx - Hv1a to sh ar e a c ommon m ec h anism of to x i c i t y with an y oth e r subst an c e s, and GS - omega/kappa - Hxtx - Hv1a do e s not a p p ear to p r odu c e a to x ic m e t a b olite p r odu ce d b y oth e r subst an ce s. F o r the pur pos e s o f this tol eran c e a c tion, th eref o r e , the E P A h a s a ssum ed th at GS - omega/kappa - Hxtx - Hv1a do e s not h av e a c ommon m ec h anism of to x i c i t y with oth e r sub st a n ce s. F ollowing fr om this, th e r ef o re , th e E P A c on c lud e s th at th er e ar e no c umul at ive ef f ec ts a sso c i at e d with GS omega/kappa - Hxtx - Hv1a th at n ee d to be c o nsid ere d. F o r in f o r m ati o n r e g ar di n g the E P A ’ s e f f o rts to d e t er mine c h e mi ca ls th at h ave a c ommon m ec h an i sm of to x i c i t y and to e v a lu ate the c umul ative e ff ec ts of su c h c h e mi ca ls, s e e the E P A ’ s w e bsite at http : // www . e pa.go v /p esti c id es/ c u mulati ve . **V . D**  **e t**  **e r**  **m i**  **n ation**  **of S** 

**a f**  **e ty**  **f or t**  **h e**  **U n**  **it e**  **d S**  **tat e** **s Pop u**  **latio n**  **, I** 

**n f**  **a n**  **ts a**  **n d**  **Ch ildr** **e n**  FF D C A s ec tion 408 ( b ) ( 2 )( C ) p r ovid e s th at, in c o n sid er ing the e st a blishm e n t of a tol eran c e or tol e r an c e e x e mption f

or a p e sti c ide c h e mi ca l r e sidu e , the E P A sh a ll a ss e ss the av a il a ble in f o r m ation a bout c onsumption p att er ns among in fants and c hildre n, sp ec i a l sus ceptibili t y of i n fants and c hildre n to p e sti c ide c h e mi ca l r e sidu e s, and th e c umul ative e f fec ts on i n fants and c hildre n o f the re sidu e s and oth e r subst an ce s with a c ommon m ec h an i sm of to x i c i t y . I n a dditi o n, FF D C A s ec tion 408 ( b ) ( 2 )( C ) p r ovid e s th at the E P A sh a ll a pp l y an a ddition a l t e n f

old ( 10X) m ar g in of s afe t y f or in f ants and c hi l dre n in the ca s e of thr e shold eff e c ts to acc ount f or p r e n at a l and postn at a l to x i c i t y and the c ompl e t e n e ss of the d at a b a s e on to x i c i ty and e x posure , unl e ss the E P A d e t er

min e s th at a di f

fe r e nt m ar g in of s afe t y will b e s af e f or in fants and c hi l dre n. This a ddition a l m ar g in of s afe t y is c ommon l y re f e rre d to a s the F ood Qu a li t y P r ot ec tion A c t S afe t y F ac to r . In a pp l y i n g this p r ovisi o n, the E P A e ith e r re t a ins the d efa ult v a lue o f 10X, or us e s a di f f ere nt a ddition a l or no s afe t y f a c tor wh e n re l i a

ble d ata ar e av a il a

ble to suppo rt a di ff

e re nt a ddition a l or no s a f

e t y fac to r . B a s e d on th e ac ut e to x i c i t y and product anal ys is d at a dis c uss e d in S ec tion I I of this do c um e nt, the E P A c on c lud e s th at th e r e ar e no thr e shold ef f ec ts of c on c e r

n to in fants, c h i ldre n, or a dults wh e n GS - omega/kappa Hx tx - Hv1a i s applied or used in accordance with label directions and good agricultural practices. . As a re sul t , the E P A c on c lud e s th at no a ddition a l m ar g in of e x posur e ( s a fe t y ) is n e ce ss ar y . Mo re ov er , b a s e d on the s ame d ata and the E P A an a l ysis a s p r e s e nt e d di r ec tl y a bo v e , the A g e n c y c o n c lud e s th at th er e is a r ea son a

b l e cert a int y th at no h ar

m will re sult to the U. S . popu l ation, in c luding in fants and c hildre n, fr om a ggr e g ate e x posur e to the re sidu e s of GS - omega/kappa - Hxtx - Hv1a in or on all food commodities when applied or used in accordance with label directions and good agricultural practices . S u c h e x posur e in c lud e s a ll anti c ip at e d di e t ar y e x posure s and a ll oth e r e x posure s f or whi c h th e r e is re li a

ble in f o r m ation. The E P A h a s arr iv e d at this c on c lusion b eca us e , c onsid ere d c oll e c tiv e l y , the d ata and in f o r m ation av a il a

ble on GS - omega/kappa - Hxtx - Hv1a do not d e monstr ate to x i c , p atho g e ni c , and / or in fec tive pot e nti a l to m amm a ls, in c luding in fants and c hildre n. **V I.**  **C o**  **n c**  **l u**  **sio n**  **s** The E P A c on c lud e s th at t h er e is a r ea so n a ble c ert a int y th at no h ar

m will re s ult to the U. S . popul atio n , in c luding in fants and c hildre n, fr om a ggr e g ate e x posur e to re sidu e s of GS - omega/kappa - Hxtx - Hv1a . Th eref o re , an e x e mption fr om the re qui r e m e nt of a tol eran c e is e st a blish e d f or re sidu e s o f GS - omega/kappa -6 Hx tx - Hv1a in or on a ll f

ood c ommoditi e s when applied or used in accordance with label directions and good agricultural practices . **V II.**  **R efe**  **r e** **n ces**  1. Draft Biopesticides Registration Action Document (BRAD) for GS - omega/kappa - Hxtx - Hv1a 2 . U.S. EPA. 2013a “GS - omega/kappa - Hxtx -Hv1a: Qualitative Human Health Assessment.” Memorandum from E . Reaves, Ph.D. and P. Shah, Ph.D. dated December 6, 2013. 3. U.S. EPA. 2013 b . “Product characterization of VersitudeTM peptide consisting of 30% GS - omega/kappa Hxtx -Hv1a.” Memorandum from J. Gagliardi, Ph.D. to S. Cerrelli dated September 11, 2013.