UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D
. C
. 20460

Debbie Mahadeo , Regulator y Affa irs Manager Monsanto Co mp a ny 800 North Lindbergh Blvd. St. Louis
. MO 63167 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### Subject: Plant- Inc orporated Protectant 

### Ba c illus th uringiensis (B. I.) Cry2Ab2 and Cry ! A. I 05 i nsect co ntrol protein and th e ge neti c m ate ri a l necessary for its production in MON 87 75 1 and the co mbined -trai t in sec t protec t e d soy b ea n 

### EPA Experimental Use 

### Permit No
. 524-EUP-1 07 

### Application Dated: Apri l 23 , 20 1 5 

### Effective Dates : F ro m the stamp ed date through December 31 , 20 1 6 ( includ es planting and associated activi ti es e.g., collection of field data, h arvest in g, processing)
. 

### Quantity Authorized: 223,200 p o und s of soybean see d co nta inin g 0.714 pound (C ry 1 A. 105 ) a nd 1
. 14 pound (Cry2Ab2). Acres: 3 ,72 0 acres in 20 s tat es plus the Co mm o n wealth of Puerto Ric o. Dear Ms. Mahadeo: On the b as i s of the information furnished by th e applicant and the a nn exed pr ogram , the U.S
. Environmenta l Protection Agency (EPA) hereby issues the sub j ect Experi m e ntal Use P ermit (EU P ) under section 5 of the Federal In sec ticid e , Fungicide , and Rodenticide Act t o tes t the Plant Incorporated Protectant ( PIP ) w ith 

### Ba c illus thuringiens is (B
. I .) C r y2Ab2 and Cry I A.l 05 insect co nt ro l protein and the ge netic m ate ri a l necessary for it s pr od ucti o n in MON 8775 1 and the comb ine d-trai t in sect protected soy bean. The EUP is aut hori ze d only in the States of A l abama (AL) , A rk ansas (AR) , Georgia (GA) , H awa ii (H I) , Illinois ( IL ) , Indiana (IN), Iowa ( I A), Kansas (KS) , Lo ui s iana (LA) , Maryland (MD) , Mississippi (MS), Missouri (MO), Nebraska (NE) , Nort h Caro lin a (NC) , O hi o (O H ) , Penn sy l vani a (PA), South Caro lin a (SC), Tennessee (TN) , Texas (TX) , Wisconsin (W I) , and the Commonwea lth of Puerto Rico (PR). It a ll ows breeding and o b servatio n nur se ri es and product c h arac t e ri zat io n for line se lec ti o n tr ia l s, t es tin g the efficacy and specificity of the transgenes , eva lu atio n of phenotypic a nd agro n om ic performance and o ptimi z ation , production of sa mpl e material for environmental risk assess me nt , and compos iti o n st udi es and to test the commercial viabi li ty of experim enta l PIP events , con du ct field trial s as needed t o s upp ort reg ul ato r y s ubmi ssio n s a nd assess ap propriate IRM programs. Shipment and u se und er this permit a re s ubj ec t to the pro vis i o n s of 40 CFR P art 172. The E P A reviewed the health and e n v ironme ntal safe ty of 

### Bacillus lhuringi ens is (B
. I
. ) Cry I A. I 05 and Cry2Ab2 proteins and ha s determined that adverse effects are no t expec ted to m a n and nontarget organi sms , includin g federa ll y listed thr ea t ened and enda ngered s pecies , as a result of the experiment s to be performed und er this EUP.Any p esticid e trea tm e nt s (e .g., he rbicide s) of th e pl a nt s und e r th e EUP mu s t have applicabl e r eg i s trations. T he Secti o n G review of thi s EU P is enclosed (US EPA/ BPPD r ev iew fro m K
. Martin to K. H ay m es, Ph.D
. , 02112/15). Prior t o s hipm ent and / or use of the s ubj ect PIP soybeans , you mu st consu lt w ith the pesticide regulatory officia ls and , if applicable , the biotechnology regulatory offic ia l s of th e States in w hi c h you will conduct yo ur experi me ntal program , a nd obtain a State permit or li cense if s uch is required
. Iss u ance of this Federa l permit doe s not negate the n eed for permission from indi v idu al States . Prior to initiating this experim e nta l program in any State , you are required to notify the lead Agency of the States in w hi c h you wi ll conduct yo ur experimental program of th e s pecifi c te s tin g pr ogram (w hen , w here, how much , etc.). Fail ure to do so may r esu lt in revocation or modification of this EUP. You mu s t co mpl y w ith a ll req uirem e nts of the USDA/AP HI S as th ey apply t o the proposed testing. Yo u must provide notice to the S ta te pe s ticide regulatory agency at least 72 hours before yo u use the EU P. You mu s t a lso provide a copy of thi s a uth orizat ion letter and s tampe d labe l , as well as th e nonconfidentia l portion of the Sectio n G Experime ntal Program , to all cooperato r s, participants and user s prior to the initi a l pesticide use made in acco rdanc e with th e EU P
. The EPA will noti fy the relevant EPA Regions of the app rova l of this EUP by sending copies of thi s approva l letter to them. Co nditions und er wh ich the EPA is is s uing th i s EUP are as follow s: I
. The tota l acreage and amo unt of PIP 

### Bacillus thuringien s is (B. I.) Cry I A .l 05 and Cry2Ab2 soy bean seed to be u sed s hall no t exceed the quantity a uth o ri zed by this EUP: 3,720 acres , including non - PIP and the border acreage of co ntro l or other non-transformed soybeans (see Table I ). The table s hows the amount of soybean seed and C ry proteins expec ted to be u sed in eac h s tate . The amo unt of soybean seed i s ca lcu lated by mu ltiplying the acres by the planting density (i
. e., 60 lb/A)
. T he m ax imum amount of Cry I A. l 05 and Cry2Ab2 protein s is the product of the a mo unt of soybean seed and th e protein percent expressio n (see US EPA/B PPD r ev iew f rom K. Martin to K. Haymes , 02112115).The an1ount (po und s) of soybean seed expec ted t o be planted in the fo ll owing 20 s ta tes plus the Com m o nwea lth of Puerto Rico over the duratio n of the EUP s h a ll not exceed the amount in Tabl e 1
. W e note that th e a pproac h to acreage calc ul at io n i s di ffere nt from prev io u s s ubmi ss ions. Trad iti ona ll y, EPA h as required Monsanto to specify the numb e r of PIP , no n-PIP , an d border acres for each eve nt co mbin atio n under investigation a lo n g with the total amo unt of protein for each protein of the co m binat i on. In add iti on , yo u we r e requ ired to s pe c ify the states ( includin g the Commonwealth of Puerto Rico) w here the EU P planting would take place. To allow more flexibility in planning and implementing the investigation of MON 87751 , wh il e still me eti ng regulatory requ ir ements, Monsanto h as proposed acreage li stin g in a m ore ge nera l wa y. Monsanto sti ll specifies the states and the comb in a ti o n s that may be used. What is different i s that th ey have reported th e total numb er of ac res in agg r egate (i.e
. , the numb er of acres th ey are requesting includ es PIP, non - PIP, and border acres) and o nl y broke them down to the sta t e level. Previo u s ly, Monsanto reported th e number of acres per s ta te and broke th ose acres down by combi n ation and border & non-PIP ac r es. The advantage of this new approac h is that Monsanto w ill be ab le to make their final deci s ion r egard in g how th e ac re s wi ll be parsed among the combinations and non-PIP & border acres c lose r to planting w hil e s till meeting r egulato r y requireme nt s. Monsanto 's final report must provide the spec ific combinations used and the acre distribution (which wou ld includ e the number of acres fo r non -PIP a nd b o rd e r). 2Tab le l : Tota l Acres , Amount of Soybean Seed ( lb) and Maximum Amount of PIP Protein (lb , g) 

### State Acres Amt Soybean CrvlA.lOS Co:2Ab2 Seed (lb) l b g 

### lb g 

### AL: 80 4 , 800 0.015 6
. 97 0
. 024 11.1 

### AR: 403 24 , 1 80 0.077 35. 1 0.1 23 55.9 

### GA: 80 4 , 800 0.0 1 5 6.97 0.024 11.1 

### HI: 2 14 12 , 840 0.041 18.6 0.065 29.7 

### lA: 432 25 , 920 0.083 37.6 0.132 60.0 

### IL: 384 23 , 040 0.074 33.4 0.1 1 8 53.3 

### IN: 1 5 1 9 , 060 0.029 1 3.2 0.046 2 1. 0 

### KS: 72 4 , 320 0.0 14 6.27 0.022 9.99 

### LA: 80 4 , 800 0.0 1 5 6.97 0.024 11.1 

### MD: 69 4 , 140 0.0 1 3 6.0 1 0.02 1 9.58 

### MO: 72 4 , 320 0.014 6.27 0.022 9.99 

### MS: 80 4 , 800 0.015 6.97 0.024 11.1 

### NC: 324 1 9,440 0.062 28.2 0.099 45.0 

### NE: 1 36 8 , 160 0.026 11.8 0.042 18 .9 

### OH: 72 4 , 320 0.0 14 6.27 0.022 9.99 

### PA: 64 3,8 40 0.0 12 5.57 0.020 8.88 

### SC: 80 4 , 800 0.0 1 5 6.97 0.024 11.1 

### TN: 80 4 , 800 0.015 6.97 0.024 11.1 

### TX: 106 6 , 360 0.020 9 .23 0.032 14 .7 

### WI: 64 3, 840 0.012 5.57 0.020 8.88 

### PR: 677 40 , 620 0. 1 30 59.0 0.207 94.0 

### TOTAL 3 ,7 20 223,200 0.7 14 323.97 1.1 4 516.33 2. Monsanto Co mpan y wi ll imm ed iat e ly n o tif y th e EPA of an y findings from the experi menta l u s es that have a b ea rin g on safe ty ( i.e
. , EPA r eq uir es repo rtin g of any adverse effec ts from the u se of , o r exposure to , the p es ticid e). Monsanto Company wi ll a lso keep record s of productio n , distribution and performance , and make the records ava il ab le on request to any authorized officer or e mplo yee of the E nvironment a l Protection Agency. 3. Monsanto Co mpany mu s t provide a final report within 180 day s of the expi ration of the permit. T he fina l report mu st include a ll ofthe items se t fort h in 40 CFR 1 72.8(b) and rep o rt on the following inf ormation :
• A State-by-State breakdown of actua l acreage per protocol ; • A State-by-State breakdown of actua l l ocati ons per protocol ; • Any c h a nges to the sta te d pro g ram , includin g approved changes to study protocols ; • A li st of s pecific counties where studie s took place.
34. P e r 40 CF R l72.4(b )(v), Monsanto Com pany mu st pr ov id e the name(s) and s treet add r ess(es) of all cooperators as soo n as avai lable a nd prior to planting
. Monsanto Co mp a ny mu s t record any changes to thi s inf ormat io n in a n updated report and s u bm it th at rep ort pri or t o planting. 5. The lab e l s ubmitted in connection w ith thi s application i s acceptab le a nd mu st accompan y a ll s hipme nt s of soy b e an s e e d under thi s EUP s ub sequ e nt to receiving thi s appro va l. Labe l s mu st a l so b e in the po ssess ion of th e u ser 

### at the time of application . A s t amped copy i s enclosed fo r yo ur reco rd s. 6. Thi s EUP i s not a limited s e ed increase reg istration under secti o n 3 of F IFRA , and plantings so lel y for commercial see d incre ase are p ro hibited
. 7. Monsanto Com p a ny mu s t fo ll ow th e co nta inm e nt procedures desc rib ed in the Section G for the EU P.
S h o uld yo u h ave questions or co nc e rn s regar din g th e iss u ance of thi s perm it , please co ntac t Or. Kenneth Haymes, of the Biop es ti c ides a nd P o lluti o n Pr eve nti o n Di v i s ion , by e mai l at haymes. kenn eth @ epa . gov or b y pho n e (703) 347 -0 398.

E ncl os ur e (s t a mp ed l ab e l) Sincerely ,

Kimb e rl y Nesc i , C hi ef , Microbial Pesticid es Branch Biopesticide and Pollution Pr evention Division.

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