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**EPA BI**  **OP ESTIC**  **I D**  **E S**  **A N**  **D P O**  **LL U**  **TI O**  **N PRE**  **V E**  **NT I**  **O N**  **DIVI S**  **I O**  **N COMPA**  **N Y**  **NOTICE O**  **F FILING**  **F O**  **R PESTICI**  **D E**  **P ETITI**  **O NS**  **PUBLIS HE**  **D IN**  **T H**  **E FE**  **DE RAL**  **REGISTER EPA**  **Biope s**  **ti c**  **ides and Pollution**  **P revention**  **D ivision**  **co nt**  **act: M**  **icro b**  **ial Pe**  **s ti**  **c id**  **e s**  **Branch, Ms.**  **Sheryl R**  **e i**  **ll y,**  **703 -**  **30 8**  **- 8059.**  **INSTR U**  **C T**  **IONS: Please**  **uti l**  **i z**  **e this**  **outline in**  **preparing t**  **he pest i**  **c i**  **de pet**  **i t**  **i on.**  **I n**  **cases w**  **here the**  **out li**  **ne e**  **l e**  **m ent**  **do e**  **s not app**  **l y,**  **p l**  **ease i**  **ns e**  **rt “**  **NA -**  **R emove”**  **and ma**  **i nta**  **i n**  **the out li**  **ne. Pl**  **ease do not**  **change the**  **ma rg**  **i ns,**  **f o**  **nt, or for**  **m at**  **i n**  **your pesti**  **c ide**  **p e**  **ti t**  **ion. Sim**  **p l**  **y repla**  **c e**  **t he**  **i nstruc**  **ti ons**  **that appear i**  **n gre**  **e n**  **, i**  **.e., “**  **[ i**  **n s**  **ert company**  **name] ,”**  **w ith**  **the info**  **rm ation**  **spec if**  **ic to your**  **a ction.**  **SUBMISS**

**I ON:**  **Email the**  **compl et**  **ed templ**  **a te**  **to: hol l**  **is .**  **l i**  **nda@epa.gov. TEMPLA**  **T**

**E:** Ba ye r CropSc i ence LP [ In sert p e t i t i on num

ber] EPA has rece i ved a p e st i c i de p e ti t i on ( [ i nsert p e ti ti on num ber ] ) f r o m Ba y er CropSc i ence LP , 2 T

. W

. A l exander D r i ve, Res e arch T r i ang l e Park, N C 27709 reques t i ng, pursuant t o s ec ti on 40 8 ( d ) of the Fed e ral Food, Dr ug, and Cos m e ti c A ct (FF D C A ), 2 1 U .S.C. 3 4 6a(d), t o am end 40 CFR part 180 ( O p ti ons ( pi ck one) 1. by es t a b l i sh i ng a t o l e r ance f

or re si dues of **N A**  **- R**  **emove** 2. t o es t ab l is h an ex e m

p ti on f rom the requ i r e m ent of a t o l eran ce f or 3. t o es t ab l is h an am en dm en t/ expans i on of an ex i s ti ng t o l e ran ce exe m p ti on f or the **N A**  **- R**  **emove** ( O p ti ons ( pi ck one) 1. m i crob i a l pes t i c i de Strep to m yces m i cro

fla vus , s tr a i n A Q 6121 2. bioche m ical pe s ti c ide [ i nsert nam e of ac ti ve i ngred i e n t ] **N A**  **- R**  **emove** 3. p l an t
- pes t i c i de [ in s ert nam e o f ac t i ve i ngre d i e n t ] i n or on [i nsert co mm od it y]. **N A**  **- R**  **emove**2

Pursuant t o sec t i on 408 ( d)(2 ) ( A )( i ) o f FF D C A , a s am ended, Bay er CropSc i ence LP has sub m itt ed th e f

o ll o w i ng summ ary of i n f

or m ati on, dat a, and ar g um en t s i n s upport of th e i r pes t i c i de p et iti on. T h i s s um m ar y w a s prepar ed b y Ba ye r CropSc i ence LP and EPA has not f u ll y ev a l uat ed the m er i t s of the p es t i c i de p e t it i on. The s umm ary m ay have been ed it ed by E P A i f the t e r

m i no l ogy used w as unc l ear, th e sum m ar y cont a i ned ex tr an e ous m aterial, or the sum m ar y un i n t e n ti o na ll y m ade the read e r c o nc l ude th at the f i nd i ngs re f l ec t ed EP A ’s pos i t i on and not the pos iti on of the pe t i ti on er . I. Ba ye r Cr o pSc i ence LP Peti t ion S umm ary [ In sert p e t i t i on num

ber] A. Product Na m e and Proposed U se Prac ti c es A Q 6121 T e chn i c a l i s th e t echn i cal g rade of the a c ti ve i ngre di ent/m anu f ac tur i ng u s e produc t
. The end

- use pr o duc t , A Q 6121 7 5 W P i s i n t ended f or use as a br o ad spec trum m iti c i de f or the con trol o f i phy

t oph a gous m it e pes t s. A Q 6121 7 5 W P i s i n t ended pri m arily f

or use on a v ari e ty of agr i cultural c ro p s. The end

- u se product i s a 75% a. i

. w e tt ab l e p ow der f

o rm ulation that is m ixed w ith w ater and a p plied a s a f

oli a r spray wi th spray equ i p m ent c o m m on l y used f or m ak i ng ground or ae ri al app l i c at i o ns and sprink l e r /i r r i gation sy s t e m s c o mm o nl y used f or c he m i gati on. It m ay be used i n a lt e rnat i ng s pray prog ra m s or i n t ank m i xes w i th o ther r eg i s t ered crop p r o t ec t i on produc t s, up t o and i n c l u d i ng the day of harves t
.
B. Product I

den t i t y / Ch em is try 1. Iden t it y o f the pes ti c i d

e and corres

pondi ng res i dues. S

tre pto m yces m i c r o

flavus , s tr a i n A Q 6121, i nc l u di ng spent f e r m ent ati on m ed i a, i s the a ctive ingre di ent in the proposed f

o rmu l at ed en d

- use produ c t A Q 6121 75 W P. S trep to myc es m ic ro f l avus i s a m esoph ili c, s aprop h yti c b a c t e r i um be l ong i ng t o the genu s S trep t o m yc es, f ound c o mm on l y i n s o i l and decay i n g vege t ati o n . 2. Magn itu d

e of res i dues at the ti m e of harves t a nd m e thod used to d e te rm i ne the residue. N o sign i f

i can t r es i dues of S

trep to m yces m i cro

fla vus , s tr a i n A Q 6121ar e expec t ed t o occur at the ti m e of harves t
. The a c t i ve i ngre d i e n t consi s t s of a natur a lly o c curring m ic r oorganism that has li ttle or no via b i l ity in the f

o rmulated produc t , the res i du e s of wh i ch have been t e s t ed i n the i r en t i r e t y (bo th T G A I and end produc t ) t o es t ab l i sh the abse n ce of t ox i c or p athogen i c e ff ec t s i n m amm a l s at l eve l s f ar i n excess of any po t ent i al r es i due at the ti m e of ha r ves t
. 3. A s ta te me nt of why an ana l y t i cal m e thod of d

e t e c ti ng and m easur i ng the l ev e l s of the p est i c i de residue a re not nee de d. Ba ye r CropSc i ence L P i s sub m itt i ng a3 pet i tion r equ esting that E PA establish an exe m p ti on f r o m the requ i r e m ent of a t o l e r ance f

or the A Q 6121 str a in of S trep to m yces m i cro

fla vus , there f

ore, an ana l y t i c a l m e thod f

or re s i dues i s n o t app li c ab l e. It i s exp ec t ed that , when used as proposed, A Q 6121 w o ul d not r esu l t i n re s i dues that ar e of t ox i co l o g i cal concern. C. Ma mm a li an Toxic ological Pr o fi l e A s the res u l t s show be l ow , and the s ub m i ss i on a pp li c ati on cl ear l y i nd i c at e, S tre p t o my ces m i cro f l avus s t r a i n A Q 6121, i nc l u di ng the natur al che m istry responsi b le f or its m itic i dal ac ti v it y, i s n ot pathoge ni c, i s not cy t o t ox i c, and i s not m

ut agen i c. A dd i t i o n a ll y, the s t andard b att er y of acut e t ox i c it y t es t s i nd i c at e th at A Q 6121 Techn i c a l and A Q 6121 7 5 W P elicit no signi f

ic ant tox i city c oncerns i n any of the t e s t s condu c t e d

. The resu l t s of the stu d i es i nd i cat e th er e ar e no s i g n i f i cant hum an hea lth r i s k s. S tud i es t o e va l uat e the s a f e t y t o m amm a l s have been condu c t ed w ith the A Q 6121 Techn i c a l and A Q 6121 7 5 W P, and are sum m ar i zed as f o ll ow s: Gu i de li ne Test

Sub j ect A Q 6121 T e chn i c a l A Q 6121 7 5 W P A cute O ral Toxicity ( O CSPP 8 7 0.1100) Rat L D 50 > 2,000 m g/kg i n s tud i es wi th A Q 6121 Techn i c a l L D 50 >5,000 m g/kg i n s tud i es wi th A Q 6121 7 5 W P A cut e D e r

m al Tox i c it y ( O CSPP 870.1200) Rat L D 50 li m it test r e su l t f or A Q 61 2 1 Techn i c a l was > 5,050 m g/kg. L D 50 li m it test r e su l t f or A Q 6121 7 5 W P end product w as > 5,050 m g /kg. A cut e Inh al ati on Tox i c it y ( O CSPP 870.1300) Rat LC50 f or A Q 6121 Techn i c a l w as > 5.26 m g/ L LC50 f or A Q 6121 7 5 W P end

- use product w as > 5.26 m g/ L Pri m ary Ey e Ir r it ation ( O CSPP 870.2400) Rabb i t A Q 6121 T e chn i c a l w as c l as s i f i ed as m il d l y ir r it ating A Q 6121 7 5 W P exh i b i t ed no adverse posi ti v e e ff

ec t s i n an y of the test ani m als Pri m ary D er

m al Ir r it ation ( O CSPP 870.2500) Rabb i t A Q 6121 T e chn i c a l non ir r it ating un der the cond i t i ons o f the t es t
. A Q 6121 7 5 W P non ir r it ating un der the cond i t i ons o f the t es t
. D e r m al Sensi t i za t i o n ( O CSPP 8 7 0.2600) Mice N/A Non

- sensi t i z er
A cute In j ec t ion (I P) Tox i c it y and Pathogen i c i t y ( O CSPP 8 8 5.3200) Rat Non

- toxic to rats when adm i n i s t er e d by

I P i n j e c ti on at a s i ng l e do s e of 1.0 x 10 9 CFU (co l ony f o r m i ng N/A4
units ) /r at. A cute In j ec t ion (IV ) Tox i c it y and Pathogen i c i t y ( O CSPP 8 8 5.3200) Rat Non

- toxic to rats when i n j e c t ed i n tr avenous l y at a dose of 3.2 x 10 10 CF U/ m L or 3.2 x 10 9 CF U/rat and is not pathogen i c i n the Sprague

- Daw l ey a l b i no rat. N/A

The resu l t s of t ox i c it y t e s ti ng w ith A Q 6121 Techn i cal and A Q 6121 75 W P support the conc l u s i on that the p ro p osed use of the ac t i ve i n g red i e n t S tre p t o myc es m i cro f l avus, s tr a i n 6121 poses no f

oreseea b l e r i sks t o hum an hea lth

. Correspo n d i ng l y, th e T i er 1 environm ental and ec o t o xicology te s ts per f or m ed as part of th e regi s tr ati o n appli c ati o n support th e con t ent i on that the u se o f th i s ac t i ve i ngre d i ent p oses no f or e seeab l e r i sks t o the env i ro nm en t
. D ue t o a l ack of r es i dues of t o x i co l o g i cal concern n e i the r d i e t ary n or non - d i e t ar y exposures w ou l d be exp e c t ed t o p o se any quan ti fi ab l e r i sk. D . Aggrega te Exposure 1. D i e tary e

xposure. i

. Food. D i e t ary exposur e f r o m use of S

trep to m y c es m i cro

f la v us , s tr a i n A Q 6121, as proposed, i s not ex p e c t ed t o po s e any t ox i c o l o g i cal concer n s. A Q 6121 i s i n t ended f

or app l i cat i o n t o agr i cu ltural c rops t o suppress o r contr o l ce rt a i n i m port an t phy

t o p hagous m it e pes t s. A cut e t ox i c i t y stud i es s h ow that S tre p to m yces mi cro

fla vus , s tra i n AQ 6121 is not t ox i c t o m am m a l s and support th e c o nc l us i on th at the p ropo s ed use of A Q 6 121 i n end

- u se produc t s poses no f oreseea b l e r i s ks t o hum an hea lth o r the env i ronm en t
. D i e t ary e x posures w o u l d not be e x pec t ed t o pos e an y qu anti f

i a b l e r i s k due t o a la ck of res i d u es of t ox i co l og i cal conce rn.
ii. D r i n k i ng wa ter. S i m il ar l y, expos ure t o hum ans f r o m res i d ues of S trep to m yces m i cro fla vus , s tr a i n A Q 6121 i n cons um ed dr i nk i ng w at er w ou l d be un li k e l y. The proposed u se patt e r n wi l l m i n i m i ze po t ent i al e x posure t o sur f ace w at e r, and expo s ure t o dr i nk i ng w at er ( w e l l o r groun d w at er) i s un li k e l y t o o ccur. A Q 6121 i s i n t end e d f or app li c ati on t o agr ic u ltur al c rops and the en d

- use product is not ap p li e d dire c tly t o w at e r . The l ack of res i du e s of t ox i co l o g i cal concern on tre at ed c ro p s and the resu l ts of t o xic i ty te s ti n g w ith A Q 6121 Techn i c al and A Q 6121 7 5 W P support th e conc l u s i on that the p ro p osed use of S trep to m y ces m i cro

fla v u s , s tr a i n A Q 6121 poses n o f oreseeab l e r i sks t o hum an hea lth or the5

env i ronm en t
. D r i nk i ng w at er exposur es w ou l d not be expec t ed t o pose any quanti f i a b l e r i sk due t o a l ack of re si dues of t ox i co l og i c al c o ncern. Further m ore, a lthough Strep to m

yces m i cro

fla vus i s a n atur a l l y occur r i ng m i croorgan i sm kn o wn to exist in t er res tri a l hab it ats (s o i l ), i t i s not li k ely t o thr i ve i n a quati c env i r o nm ent s. 2. Non

- di e ta ry exposure . The po t enti al f or non - d i e t ar y expos ure t o the ge n e r al popu l at i on, i nc l ud i ng i n f

an t s and c h i l dren, i s un l i ke l y as the p roposed use si t es ar e agric u ltural sett ings. S

tr ep to m yces m i cro

fla vus , s tr a i n A Q 6121 i s i n t e n ded f or appli c ation t o agric u ltur a l crops to c o ntrol i m portant phy

t op h agous m ite pes t s. The l ack of t ox i co l o g i ca l l y s i gn i fi can t re s i dues on tre at ed c ro p s, the r e su l t s of t ox i c it y t es ti ng w ith A Q 6121 Techn i cal and A Q 6121 7 5 W P support th e conc l u s i on that the p ro p osed use of A Q 6121 p o ses no f ore s eeab l e r i s k s t o hum an hea lth o r the env i ronm en t
. Non

- d i e t ar y exposures w ou l d not be expec t ed t o pose any quan ti fi ab l e r i sk due t o a l a ck of res i du e s of t ox i co l o g i cal concern. A ddition a ll y , Personal P r otec t ive Equ ip m ent (PP E ) m itigates the potent ial f or exposure t o app li c at o r s and hand l ers of the proposed produc ts , when used i n agric u ltural sett ings.
E. Cu m ulative Eff

e cts W hen used as proposed, it is n o t exp ected that Strep to m yces m i cro

fla vus , s t r a i n A Q 6121 w ou l d resu l t i n re s i dues that ar e of t ox i co l o g i cal concern. A Q 6121 i s i n t e nded f or appli c ation t o agric u ltur a l crops to s u ppress or c o ntrol ce rtain i m port ant phyt ophagous m it e pes t s. Based on th e resu l t s f

r o m m amm a li an t ox i c it y t es t s w ith A Q 6121Techn i cal and A Q 6121 7 5 W P there i s no i nd i cat i on of m amm a li an t ox i c it y of Strep to m y c es m i cro

fla vus s tr a i n A Q 6121 and no i n f o rm ati on t o i nd i c at e th at t o x i c e ff ec t s w ou l d be cum

u l ati ve. O ur curre n t unders t an di ng i s th at S tr ep to m yces m i cro

fla vus s tr a i n A Q 6121 does not share a co mm on m echan ism of toxici ty with any o t her register e d substance. Therefore f o r the purposes of th i s t o l e ran c e exe m p ti on pe t i ti on, B a yer CropSc i ence LP re ques t s th e assum p ti on that Str ep to m

yces m i cro

f lavus s tr a i n A Q 6121 d o es not have a co mm on m echan is m of t ox i c it y w ith o th er sub s t ances and there f ore no cum

u l ati ve e f f ec t s a sso c i a t ed w ith S

tr ep to m yces m i cr o

f lavus s tr a i n A Q 6121 w ou l d be exp e c t ed.

F. Sa f e t y De t erm i na t i on 1. U .S. popu la ti on. When used as p r oposed, S tr e p to m yces mi cro

fla vus , s tra i n AQ 6121 w ou l d not res u l t i n res i du e s th at are of t ox i c o l og i c a l co n cern. A Q 6121 i s i n t end e d f or app li c a t i on t o ag r i cu l tur a l crops t o con tr o l i mport an t phy t ophagous m it e p e sts. T h e6

l ack of t ox i c o l og i c a ll y si gn i f i cant re s i dues on tre a t ed crops an d the res u l t s of toxicity t es t i ng on A Q 6121 Techn i cal and A Q 6121 75 W P support the con c l us i on that the proposed u s e of AQ 61 2 1poses no f orese e ab l e r i s ks t o hum an hea lth o r th e env i ronm en t
. There i s a r e asonab l e ce rt a i n t y of no harm t o the gener a l U S popu l at i on f rom exposure t o this a cti v e i n gredie n t. 2. In f an t s a n d ch ild

r en . A s m enti on e d above, i t i s not expe c t e d that , when used as proposed, S

trep to m yces m i cro

fla vus , s tr a i n A Q 6121 w ould result in r e si d ues th at are of t ox i c o l og i c a l conc e rn. There i s a r ea sonab l e c ert a i n t y of no h arm f or i n f ant s and c h il dren f r o m exposure t o A Q 6121 f r o m the proposed u s es G . E ff ec t s o n the I mm une and Endocr i ne Sy s t e m s S trep to m y ces m i cro

fla v u s s tr a i n A Q 6121 i s a n atura l l y occur r i ng, non - p at hogen i c organ i s m . To da t e th e r e i s no ev i d e n ce t o sugge s t th at S tre pto m yces m i c r o

fl avus s tr a in A Q 6121 w i l l co m

pr o m i se the i mmune or endo cr i ne sy s t e m s, or th at i t func ti ons i n a m anner s i m il ar t o an y kn o wn ho rm o n e, or th at i t a c t s as an en d ocr i ne d i sr up t er.

H . Ex is ti ng To l erances There i s no U S EPA To l e r ance f or Strep to m

yces m i cro

fla vus s tr a i n A Q 6121. I. In te rna t i o nal To l era n ces The r e i s no Codex A li m ent ar i us C omm i ss i on Max i m um Res i due Level ( M R L) f or S trep to m y ces m i cro

fla v u s s tr a i n A Q 6121.

January 25, 2013