Matthew Pe nce, Ph.D. Regulatory Manager J .R. S im pl o t Co mp a n y 5369 West Irving Street Boi se , ID 83 706 UNITED STATES ENVIRONMENT AL PROTECTION AGENCY WAS HINGTON , D
. C 20460


# D

EC 17 2 015 OFFICE OF CHEMICAL SAFETY AND POLL1JTION PREVENTION



### Subject : Ame ndm ent to th e Ex p erimenta l Use Perm it for VNT I
. prote in and the ge neti c m ater ia l 

### (Rpi

- vntl gene fro m pl as mid pSIM 16 78J nece ssary for it s production in InnateTM 2.0 branded potato var i eti es fo r research on re s i stance to 

### Phytophlora inf es tans (co mmonl y kn own as late potato blight)
. 

### E

PA Experimental Use 

### Perm it No. 891 7 -EUP-2 

### A pp licatio n Dated: Jun e 30. 20 1 5 

## , Effective Dates : From the s t a mp e d date through Apri l I. 20 17 ( in cl ud es planting a nd assoc iated activ iti es e . g., co ll ection of field d ata. h a rv est ing, process ing). 

### Quantity Authorized : 13,000.000 pounds of seed potatoe s co ntai nin g 0.390 pound (3.90E -01 ) lb
. Vnt l protein (see T able 2). 

### Acres: 5.576 acres total. inc l uding 5.200 

### ac re s R p i-vntl Pl a n t In corporated Protectant a nd 376 maximum border acreage of co ntrol or ot h e r n o n-tran sfo rm e d potatoes . Dear Dr. Pence: On the basi s of th e in fo rm ation furni shed by the appli cant , the U .S. En viro nm e nt a l Protection Agency (EPA) hereby a me nd s the s ubj ect Experim e nt a l Use Perm it (EU P) und e r sectio n 5 of the Federal In sec ti c id e , F un gicide , a nd Rodenticide Act to te st a Plant In corporate d Protectant (P l P ) exp ress in g the YNTI protein a nd th e ge n et i c materia l 

### (Rpi-vntl ge ne from pla s m id pSIM 16 78) necessaly for its production in Inn ateTM 

### 2 .0 branded potato varieties. T hi s EU P i s being conducted for re search on res istance to 

### Phytophtora inf estans (commonly known as l ate potato blight). Amendment s to th e EU P are b ei ng m ade to in c rease th e app roved acreage a nd effec ti ve date s of th e penn i t. Th i s a mend ed EU P i s a ut h o ri ze d o nl y in th e States of Arizona (AZ) , Ca li fo rnia (CA) , Co lorado (CO) , F l o rid a (FL). Haw ai i (H I), Id aho ( ID ), Illin o i s (IL ) , Indi a n a (IN ), Ka n sas (KS) , M a ine (ME) , Michi gan (M l ) , Minne sota ( M N) , Missouri (MO) , Ne bra s ka (NE) , Neva d a (NY)
. New Mex ico (NM). New York (NY) , North Carol ina (NC) , North Dakota (ND) , Oregon (O R)
. P e nn sy lvania ( PA ) , So uth Caro lin a (SC), Texas (TX) , Utah (UT)
. Was hington (WA) and Wisconsin (WT). lt a ll ows lin e se lecti on trials
. test in g th e efficacy and specificity of the transge ne s, evalu ati on of agro n omic performance a nd o ptimi zati o n , produ ctio n of sampl e m aterial for enviro nmen t a l ri s k assess m e nt , co mp os iti on s tudie s. a nd to test the comrn e r c i a l v iabili ty of experi m e nt a l PIP event s a nd assess appropriate f un g icide p rograms. S hipme nt a nd u se und er thi s p erm it are s ubj ect to the p rov i s i ons of 40 CF R Pait 1 72. The E PA rev iewed th e h ea lth and e n v i ro n m ental safety of VNT I prote in and h as determined that adverse effects are n ot expecte d to human s and nontarget orga ni sm s. in c ludin g fede rall y li sted threate ned a nd end an ge red spec ies, as a re s ult of the experiments to b e p erform ed und er t hi s EUP
. Any p esticides (e.g., he rbi c ides ) u sed to treat the p lan t s und e r th e EU P m u s t have ap pli cab l e reg istratio n s . T h e Secti on G review of thi s EU P i s e nc l osed (US EPA/ BPPD rev iew from K
. Martin to K
. Hay me s, 9 / 21 /15).Pri or t o shipment and/ o r u se of th e s ubj ec t PIP p o ta to , yo u mu st co n s ult w ith th e pe s ti c id e re g ulatory o ffi ci al s a nd
. if appli cable
. th e bi o techn o logy re g ul a to ry o ffi c ial s of the S tat es in w hi ch y o u wi ll co nduct yo ur ex p e rimental program , and o bta in a Sta te permit or licen se if s uch i s re quire d. Iss uan ce o f thi s Fe deral perm it d oes not n ega te the n ee d for permi ss io n fr o m indi v idual S t a te s. Pri o r to initi a tin g thi s ex perim e ntal pro g ram in a n y S tate , yo u a re required to n o ti fy th e lead Age n cy of th e S tate s in w hi c h yo u w ill co ndu c t yo ur expe rim en tal pro g ram o f the s pecifi c te s tin g pro g ram (w h e n . w h e re , h ow mu c h , e t c. )
. Fai lure t o d o so may re s ult in revoca ti o n o r modification of thi s EU P
. You mu s t co m pl y with a ll requirements of the US D A / APH IS a s the y appl y t o th e p ro pose d test in g. Y o u mu s t provide n o tice t o the S tate pe s ti c id e re g ul a to ry age n cy a t lea s t 72 h o ur s be fore yo u u s e the EU P. Y o u mu s t al so pro v ide a co py o f thi s a uth o ri za ti o n letter a nd s tamp e d label , as we ) 1 as th e n o n -co nfid e ntial pottion o f th e Sec ti o n G Ex perimental P rogra m , to a ll coo perato rs. parti c ip a nt s a nd u se r s pri o r t o the initi a l pesticide u s e made in a cco rdan ce w ith"th e EU P
. T h e E PA w il l n o ti fy t he rel eva nt E PA R eg i o n s o f th e a pproval o f thi s EU P by se ndin g co pi es o ftbi s a pp rov al le tt e r to them
. Co n diti o n s under w hi c h th e E PA is iss uin g thi s EU P a r e a s fo ll ow s: I. The total acreage a nd amount of Pl P see d potat oes to be u se d s hall n o t excee d the quantity a uth o rize d by thi s EU P : 

### 5 , 576 a cre s . includin g 

### 5.2 00 ac re s o fVNTI Pl a nt In co rp o rated Protectant a nd 

### 376 ma x im um bord er ac rea g e o f co nt ro l o r o th e r n o n-tran sfo rm e d po tatoes (see Ta bl e I )
. T he ac reage of see d p o tatoes planted in th e fo ll ow in g 26 s tate s over the durati o n of the EU P s h a ll n o t exc ee d the a m o un t in Ta bl e 1. 

### Table 1. Prop ose d A creag e Di s tributi o n amo n g th e 26 State s S tate PIP Non P IP T otal 

### AZ : 

### 10 5 15 C

A: 

### 50 1 0 60 CO: IO 

### 5 15 Fl: 

### 50 10 60 HI: IO 

### 1 

### 11 ID : 

### 700 50 

### 750 IL : 

### 10 5 L S 

### I N: 

### 10 5 15 KS : 

### 10 5 

### 15 ME : 

### 30 5 

### 35 M l : 

### 600 5 0 

### 650 A1N : 

### 300 15 315 MO : 

### 50 5 55 NC: 

### 5 0 l O 

### 60 ND: 

### 1 30 10 140 NE: 

### 800 50 850 NM : 

### 10 5 1 5 NV: 

### 400 1 0 410 N Y : 

### 50 5 

### 55 OR : 

### 400 10 41 0 2

### S tate PIP No n PIP To t a l 

### PA: 30 5 35 

### SC: 10 5 15 

### TX: 50 10 60 

### UT: 700 5 0 75 0 

### WA: 1 30 1 0 14 0 

### WI: 600 25 625 TOTA L: 5 , 20 0 376 5,576 2. J .R. Si mpl o t Co mp a ny is pro p os. in g to u se t hree p ro t oco l s, as d esc rib e d in t h e e n c lose d BPPD rev ie w of t h e Sec ti o n G ex p e ri men tal progra m (9 / 2 1 / 20 1 5). Th e num b er ofac re s, a m o unt of pota t o see d , a n d m max i mum a m o unt of pro t e in fo r eac h tr ia I , acco rd in g t o th ese p ro t oco l s, a re p rov id e d in Ta bl e 2. T h e a m o unt o f seed po t at oes is ca lcul a t ed by multip lyin g t h e ac res by th e pl a ntin g d e n s ity ( i .e., 2,5 00 lb/A). T h e m ax imu m a m o u nt of VNTl p ro t e in i s t h e pro du c t of t h e a m o un t of see d p o tat oes ( p o und s) a nd th e p ro te in p e rce nt ex press io n (see US E P A BPPD rev iew fr o m K
. Martin t o 

### K. H ay m es, 0 9/ 21/15). 

### T able 2. Ex p e r imental Protoco l: Ac res an d A m o unt of P IP Prote in (l b, gra m s)


### Acres 

### Amo un t ofPIP Materia l Protocol PIP NON-P IP L b a e,·



### Researc h a nd D eve lo pm e nt 15 10 l.13E-03 0.51

R eg ul atory 35 20 2.63E-03 1. 1 9
Agro n omy O ptimi zat ion 5.150 346 3.86E-Ol 1 75.20 

### TOT A L 5,20 0 376 3.90E-Ol 17 6.9 0

3. J. R
. Simplot Company wi ll i mm e di a t e ly n ot i fy th e E P A ofa n y fi ndi ngs fro m th e ex p e rim e nt a l u ses t h at h ave a bearin g o n safety ( i .e . . EP A req uir es re p o rt ing of a n y adve rse effec t s fr o m th e u se of, o r ex p osu re to , th e pe s ti c id e). J
. R
. S impl ot Co mp a n y w ill a l so kee p records of p ro du ct i o n , d i s t r ibuti o n a nd p e rfo rm a n ce, a n d m a k e t h e record s available on re qu es t t o a n y a uth or ize d office r or e mpl oyee of the Environmental Protection Agency. 4. J. R
. S im pl ot Co mp a n y m u s t p rov ide a fin a l re p ot i w ithin 1 8 0 d ays o f th e exp irati o n of th e pe rmit. T h e fi n a l repo 11 mu st in c lu de a ll of t he ite m s set fo 11h in 4 0 CF R 172 .S( b ) a nd re p o rt o n t h e fo ll ow in g information: 

### 3

### A State-by

- State breakdown o f actual acreage per protoc o l : A State-by-State b r ea kdown o f ac tu a l l oca tion s per protocol ; A n y c h a n ges to th e stated program . in cl u ding approved c h anges to st u dy prot oco l s; A li st of s pecific co unt ies where s tudie s t oo k p lace . 5. Pe r 40 CF R 1 72.4(b)(v)
. J .R. S impl ot Co mp an y mu s t provi d e the name( s) and street addre ss(es) of all cooperators as soo n as ava il ab le and prio r to p l a nt in g. J .R. S im pl ot Co mpa ny mu st reco rd a n y c h a n ges to thi s in fo rm ati on in an updated re port a nd s ub mi t t hat repo ll prior to plant in

_ g. 6. T he labe l s ubmitte d in connection with thi s application is acceptab le a nd mu st accompany a ll s hipm ents of potato seed und e r th i s EU P s ub s~ q ue nt to rece ivin g thi s approval. Labe l s mu st a l so be in th e pos s essio n of t h e u ser at th e time of p l anti n g. A sta mped co py i s enc lose d for you r record s. 7. Th i s EUP i s n ot a limit ed se ed in creas ,e regi st rat io n und e r sec t io n 3 o f FIFRA , a nd pl anti n gs so le ly for commercia l seed in crea se are p rohi b ite d
. 8. J.R
. Simp lot Com p a ny mu st fol l ow the contai nm ent proc ed ure s desc ri bed in the Section G (dated A u g u st 26 , 2015) for the EU P
. S h o u ld yo u h ave q u es ti o n s or co n cerns regarding the i ssua nce of thi s perm it. p lea se co ntact Dr. Kennet h Ha ymes . of the Bi opes ticide s and P o llu tio n Prevent io n Di vis io n . by ema il at hay me s .kenneth a 

### epa.gov o r by ph o n e (703) 347-0398. Sincereh.

En c l os ure s : E PA Sect ion G review a n d stam ped labe l



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