UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WAS HIN G T O N , D
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## APR 3 0 2015

V ick ie Fo r s t e r, R eprese nt a ti ve to SGC N ursery, LL C So u t h ern Gard e n s C it ru s, LLC 1820 Co untr y Roa d 833 C lewisto n , FL 33 4 40 OFFICE OF C HEMI C AL SA FET Y A N D P OL L UTI O N PRE V ENTI O N

S ubject: Pl a n t In co rp ora te d P r o tec t a nt ( PIP ) w ith t h e S pin ac h d efe n s in pro te in s (So D 2 a nd So D 7) and th e ge n e ti c m a te ri a l n ecessa ry for th e ir pro du c ti o n w h e n ex presse d in c itru s pl a nt s. E PA Exp e rimental Us e P e rmit N o . 88232

- EU P-1 A pplication Dated : Jun e 6, 20 1 4 Effectiv e Date s : F r o m th e s ta m pe d d a te thr o u g h A p r il 1 8, 20 1 8 (i n c lud es p l an tin g and assoc i ated ac ti v iti es e.g . , co ll ec ti on of fie ld d a t a , h a rvest in g , process in g). Quantity Authorized : 50 k g ( in F lo rid a) a nd 25 kg ( in Texas) of act i ve in g re di e nt (see Tab le 4). A cres : 720 ac res in F lo rid a a nd Texas (600 P IP a nd 1 20 b or d er) to tes t fo ur in se rt io n eve n ts (SGC

- 41 1 08

- 7 , SGC -41 332

- 6 , SGC -11 3 1 9

- 8, a n d SGC -11 208

- 5) th a t p ro du ce two p rote in s (So D 2 a n d/ or So 0 7). Dear Ms
. Fo r s te r: O n t h e bas i s of t h e in for m a ti on furni s h e d b y th e app li ca nt , th e U.S. E n v ir o nm e nt a l Pro tecti o n Age n cy (E P A) h e re b y iss u es th e s u bjec t Exper im e nta l Use P e rmi t (EUP) un de r sec ti o n 5 of th e Fede ra l In sec ti c ide, F un g ic id e, a n d R o d entic id e Ac t to t es t th e Pl a nt In co rp o ra ted P ro tec t a n t ( PI P) w ith th e spi n ac h d efensi n pro t e in s (So02 a nd So 0 7) an d th e ge n e ti c m a te ri a l n ecessar y for th e ir p rod u c ti o n w he n expressed in c it ru s pl a nt s. Th e EU P is auth o ri ze d o nl y in th e S t a tes of F lo ri da (FL) an d Texas (TX). It a ll ows eva lu a ti o n of sp in ac h d e f e n s in (So D 2 a nd So D 7) p ro te in s in pl a nt ti ss u es, eva lu a ti o n of co mp os iti o n a l a n d nutri t io n a l d a t a i n raw an d p rocesse d c itru s co mm o diti es pro du ced fro m eac h eve n t, assess m e nt of no n - t a r ge t o rga ni s m s t o di sease res i s t an t c itru s , tes tin g to d e t e rmin e th e efficacy a n d spec ifi c it y o f th e tr a n sge n es, eva lu a ti o n of ag r o n o mi c p e rf orm ance a n d o p t imi z a ti o n , prod u c ti o n of s a mpl e mater i a l for e n v ir o nm e nt a l ri s k assess m e nt , co mp os iti o n a l s tu dies a n d to t est th e co mm erc i a l viab ility of ex p e rim e n ta l P IP eve n ts. S hipm e nt a n d u se u n der t h is p er m it are s ubj ect to th e pr ov i s io n s o f 40 CFR Par t 1 72. T h e EPA rev iewe d t h e h ea lth a n d e n v ir o nm e nt a l safe t y of s pi nac h defe n s in p ro te in s a n d h as d e te rmin ed th a t a d ve r se effects are no t expe cted to m a n a n d n o nt a rge t organi sms, i ncludin g fede r a ll y li s te d threa t e n e d a nd e n da n gered s p ec i es , as a res ul t of th e ex p e rim e n ts to b e perfo rm e d un de r thi s EU P
. A te m po r ar y to le ra n ce exe m pt io n fo r t h e So 0 2 a nd So07 s pin ac h d efe n s in p ro te in s has bee n estab l i s h e d co n c urr ent l y w ith t his EU P
.

### A n y pes ti c ide tr ea tm e nt s ( e .g. , he rbi c id es) o f th e pl a nt s und e r th e EU P mu s t h ave appli ca bl e regis tr ati ons. T he Sec ti o n G r ev iew of thi s EU P i s e ncl ose d (US EP A/ BPPD r ev iew fr o m K. Ma rtin to K
. Hay mes, Ph.D ., 03 / 3 1/15). Pri o r to s hipm ent and / or u se of th e s u bjec t PIP s pin ac h d efe n s in prote in s (So 0 2 a nd So 0 7) in c itru s p la nt s, yo u mu s t co n s ult w ith the p es ti c id e r eg ul ato r y offic ia l s a nd , i f appli cab le , the b io tec hn o logy r eg ul at o ry o ffi c ia l s of th e Stat es in w hi c h yo u w ill co nd uc t yo ur ex perim ent a l prog ram , a nd o bt a in a S t

a t

e pe rmi t o r li ce n se if s u c h is r e quire d. Iss ua nce o fthi s Fed era l pe rmit does no t nega t e th e n ee d fo r pe rmi ss io n f r o m indi v idu a l States. Pri o r t o initi atin g thi s ex pe rim e nt a l prog ra m in a ny S tate, yo u are require d to no ti fy th e lea d Age ncy of th e S t a t

es in w hi c h yo u w ill condu ct yo ur ex pe rim e nt a l prog ra m of th e s pec ifi c t es tin g prog ra m (w he n , w he r e, how mu c h , etc.)
. Fa ilure t o do so may r es ult in r evoca ti o n o r mo di fica ti o n of thi s EU P
. Yo u mu s t co mpl y w ith a ll r e quire me nt s o f th e US D A / A PHI S as th ey a ppl y to the proposed tes tin g. Yo u mu s t prov id e no ti ce to th e S tate pes ti c ide r eg ul a t ory age ncy at l eas t 72 ho urs befo r e yo u initi ate th e EU P
. Yo u mu s t a l so prov id e a copy o f thi s auth o ri za ti o n l e tt e r a nd s t a mp ed label, as we ll as the non con fi dent ia l por ti o n of th e Sec ti o n G Expe r imen ta l Prog ram, to a ll coo p e rat ors , pa r ticipa nt s a nd u se rs pr io r t o th e initi a l pest ic id e u se m ade in acco r da nce w ith th e EU P
. T he EPA w ill not i fy th e re levan t E PA Regio n s of th e app r ova l of thi s EU P by se ndin g cop ies of th is a pp rova l le tt e r to th e m. T he eve nt s, th e ir ex presse d pro te in s, a nd th e ty pe of c itru s in c lud ed in thi s EU P are li s ted in T a bl e I:
Ta bl e 1 : Eve nt s, Pro te in s, a nd T y pe of C itru s Eve nt Pro t e in C itru s T y pe SGC

- 4 1 I 08

- 7 So02 swee t o ra n ge SGC-4 1 332

- 6 i 

### So 0 2 , So07 swee t o ra nge SGC -11 3 19

- 8 So 0 2, So07 le mo n SGC -11 208

- 5 So 0 7 g ra pef ruit
'--- 

### So 0 2= Defe n s in 2; So 0 7 = Defe n s in 7
T he Co nditi o n s und e r w hi c h th e EP A is i ss uin g thi s EU P ar e as f o ll ows: I . The t o t a l a mo unt o f ac r es So uth e rn Ga rd en s C itru s inte nd s t o pl a nt i s a m ax imum of 720 ac res at tes t s it es in Flo rid a a nd Texas. Th e tota l ac r eage a nd a m o unt o f P IP pl a nt s to be u se d s h a ll no t excee d th e qu anti ty auth o rized by thi s EU P : 720 ac r es, in c ludin g 60 0 Pl a nt In co rp o ra te d Pr o tec t a nt a nd 120 max imum bo r der ac r eage of co nt ro l o r o th e r non -t ra n sfo rm ed c itru s pl a nts (see Tab le 2). Th e t a bl e s hows th e a m o unt of p la nt s pe r ac res a n d th e bord e r s to be u se d in eac h s tate a nd in w hi c h co unt y.

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### Tab le 2: Summary of Acres by Event, T y pe (P IP , Border), and Location

Hendry County, FL: Hidalgo County , TX: 

### Total PIP: Total Border: SGC -41 1 08-7 PIP Border 100 20 50 10 150 30 SGC-41332-6 PIP Border 100 20 50 10 15 0 30 SGC-1 1 3 1 9 -8 SGC-11208-5 PIP Border PIP Bord e r 100 20 100 20 50 1 0 50 10 1 50 1 50 30 30 TOTAL PIP Border 400 80 200 40 600 120
2. The following Table 3 shows the amo unt of protein (kg) that is expected for eac h eve nt of the EUP study. The amou nt of protein was calcu lated by multipl y in g the acres by the p lanting dens i ty ( i .e. , tree s/ acre) by the amount of leaf material per tree (kg. dry we i g ht ) by the percent of active ingredient. Due to uncertaintie s regarding the mea s ured concentration of SoD2 and SoD7 protein s

Table 3 in the leaf material , Sout hern Gardens C itru s propo se d a conservative approac h , where the maximum conce ntr at ion measured ( i .e . , > 20 mg/ kg) was ro und ed up to 25 mg/ kg and this va lu e was used in the calcu lation for a ll four eve nt s. Unde r this sce nario , the tota l amou nt of protein (kg) is expected to be 75 kg; see Tab le 3 for the amount for eac h even t and county. Amo unt of Protein Expected Assuming a Co ncentrat io n of 25 mg / kg for Eac h Event
Hendry County, FL: Hida l go Coun t y , TX: 

### Total: SOC41108-7 1 2
. 5 6.25 1 8.75 SOC

41332-6 12.5 6
. 25 1 8.75 SOC- SOC- TOTAL 11 3 19-8 11 208

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1 2.5 1 2.5 50.0 6.25 6.25 25.0 18. 75 1 8.75 75
.0 3. Southern Gardens Citru s wi ll immediately notify the EPA of any findings from the expe rim enta l use s that have a bearing o n safet y (i.e., EPA requires r epo rtin g of any adve r se effects from the u se of, or ex posure to , the pe s ticide). Sou th e rn Garden s Citrus wi ll a l so keep record s of production , distribution and performance, and make the records ava il ab le o n request to a ny authori ze d officer or e mployee of the Env ir onmenta l Protection Age n cy. 4. Sou th ern Gardens Citr u s mu s t provide a final report w ithin 1 80 days of the exp ir ation of th e permit. The final report mu s t includ e a ll of the items se t forth in 40 CFR 17 2.8( b ) a nd report on the fo ll owing in formation:
• A State

- by-State breakdown of actual acreage per protocol • A State-by-State breakdown of actual locat i o n s per protoco l 3• A n y c h a n ges to th e s t a t e d pr og r a m , including appro ve d c han ges t o s tud y pro t oco l s a nd • A li s t of s p e cific co unti es w h ere s tudie s took p l ace 5. P e r 40 CF R 1 72.4( b )(v) , S o uth e rn Gard e n s C itru s mu s t pr ov id e t o th e E PA th e n a m e(s) a nd st ree t ad dr ess(es) of a ll coop e r ato r s as soo n as avai l a bl e a nd prior t o pl a ntin g. Southern Garden s Ci tru s mu s t reco rd a n y c h a n ges to t hi s in forma ti o n in an upd a ted re port a nd s ubmit th a t re p o rt pri o r t o p l a ntin g. 6. The l a b e l s ubmitt ed in connection with thi s a pplic a ti o n i s acce pta bl e a nd mu s t acco mp a n y a ll s hipment s of bre e din g mat e ri a l und e r thi s EU P s ub seq u e nt t o r ece i v in g thi s ap pr ova l. Lab e l s mu s t a l so be in th e po ss e ss i o n oft h e u se r a t the tim e of a pplic a ti o n . A s tamped copy i s e ncl osed fo r yo ur record s . 7. Thi s EU P is not a limited breeding r eg i s tration und er s ection 3 of FIFRA , an d planting s so l e ly for co mm e rc i a l bree din g purp oses a re pr o hibit ed
. 8. So uth e rn Garden s C itru s mu s t fo ll ow th e co nt a inm e nt p r oced ur es d es cribed b y So uth e rn Gar d e n s C itru s in the Section G s ubmitt ed in s upp o rt of th e EUP (se e MR ID # 494093

- 03). S h o uld yo u h ave qu es ti o n s or co n ce rn s rega rdin g th e i ss u an ce of thi s p e rmit , pl ease co ntac t Dr. K e nneth Ha y m es , of the Bi o pe s ti c id es a nd Pollution P reve nti o n D iv i s i o n , b y e m a il at h ay me s .ken n e th @ e p a.gov o r b y ph o ne (703) 34 7-0398. S in ce re ly,

Kimb e rl y Nes ci , C hi e f , M i c r ob i al Pe s ti c id es Branch Biope s ti c id e a nd Polluti o n Prevention Divi s i o n .

E n c los ur es (s t a mp e d l abe l a nd Marc h 3 1 , 2 015 Section G rev iew)



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