ll o<:kc t Numbe r EPA-HQ-O PP-2 0 1 5 - 02SI 

### www. r cgu1ations.gov


# Aspergillusjlavus Final Work Plan (PC Codes: 006456 and 006500) Registration Re v i ew

C: 1 se Number 

## 6008 D ece m b e a · 

## 2015

A p prove d 

### by:

# gl·':~j R obcrt McNally. Director 13iopcst i c id cs and l' o llul ion 

### Prevent i on Di vision Date :I i\'TIWO UCT I O 'i I h is i s the U.S. E n

\'ironmcntal Pr otect io n , \gcncy's (EPA) Fin :tl Work Plan (I : WI') for the Rq ;is t r.

lli o n Rc, ' i cw o r

**bJ~t r'J,;illu**  **s** jlnrtts . 1 1l iS F\V I' f Ollows t he l)n:l imin:uy Work l )lan ( PWI' ) pos te d in llw Rt: !; i :>t r :ulo u ltc" i c w dockcl for

**1.\p,·r~Uius** jlm·u.'( (E J• J\. JI Q·OPP-20 1 5-028 I ).

**TIH\~C** products (o uc m:mu 1 :1cturins usc and t wo ..:nd usc p r oducts) J mvc

**hc~u** n:sistc r cd th at contain eithe- r oft,,n s trnin .s of

**Asprr~UIII.'** jlm · m :u nn acti' c inf:rcdicnt . 11u: end u..;c products nn! regi stered for uSC' to coutrol

**atl:uoxin·pnxtucin~** fungi on co114:'n. c:<'m. pist;Khios. nnd pc:.anuts. ; \11:u oxins 

### :m: n.Jturally occurring mycotO . \in.' produC\."'\1 by some:

**~trJ.ins** of

**rs:11lru** Jltn ' t6 and arc among the mo.st

**can:in og**  **~nic subsc.:anc('~**  known. ' I he l\\0 s1r.sir1' of A.fJNrJ:il/uf j/m•rt.'i th.lt nrc

**conlnin~.'\1** in the rcs i stcm:l product s do not procluc'-' nfl:tto:\iJU , **nu:~~** strains :m:

**~;pagillus**jlll\'IIS AF.16 h l u.l A . ,f

NrJ;illliJ jlm •u:t N RRL 2 1 882.

**.o: pL·r~illm**  **·** jlm·110: t\F36 was i sol;: u cll in Ariz ona 11nd is OllSO found i n Tcx!l s, wh ile

**J~t:rgillfls** jh n •

u

, , · NR it L 21882 wn s i solated f r

om n pc : 111u 1 $ ecd in Geo r gia. When ll J l J

l1h:d t o co non . corn. pi s tnchiv. and peanut n t th..: ri ,; . httiml! (p• cbl oom). t he:sc

**~troins** of 

### Aspugillu s

jlm · , JS arc cxpcc . tc d to di:r.r lacc t he

**afl oxin**  producing str.Jins Of

**'Jh'f}~illus** flm'U.o: from the 

### uop ;md lidd. The UP 1 \ is

**implcmcntin~** the Rq;istr.nion Rc\ · it\\ progr;1.01 pwsu:mt to S\."Clion 3(S) oflhc Fcdcrnl l nsccticidc. fungicide. and Rodl.!'nticid c Act (FIFRJ \ ) :1nd \\ill n:\ · icw each registered rcsticidc c\ ·cry 1 5 )l!.tr1' to J cccm l i

n

c whether 

### it cont i nues t o meet the FIFRJ\ stan dard for r

q; i s t r.tt io n. Chan scs i n s cient<.·. rublic

**polic~ .**  n nll

**rc~t llL'**  usc pmcticc.· s

**(IC~ ur**  (l\'Cr time . The l ( q;,ist r a

tion Rc vic.·w J UOa;r:u n is i ntended

**~kc** s ur..: t hat. Ol$ t h e :tl'l ilit y t o :1ssc. · ss ri $k

**c\ \'~S**  and

**11.~** J >OJ ici c s and r rnc t ic c s change . a ll rc gistc:rcJ pest i cides co nt i n

ue t omcc t t hc s tntu l of) ' :s tand:t r d of no unrc:uonnblc od w rse cff ...
**~ts** t o h uman l u · :ahh or t he cn\'iromncnl. lltc J lub l ic phase of Rcgistr.ui on Rc\ icw bi:gjns when the initial docket is opcnc."<J fl''r c.1ch C:J.S(' . lnfonn : 1ticm on lhis progr.un is pro\idcd on the EPA ·s \\ebsitc . 1 Thi: FWP begins \',ith any updates siocc the fl\\'J' \\ M issued. Next. it

**pr<wh.J~s** n summ:uy of s ub stan t i\'C c omments

**r~;.'<'civc..J .**  if any. durin g the pub l ic conuncnt period for the PWP

**~.:ouc,·rn ng**  an t icip:m:d dmn needs, cxpccl'- '< 1 

### risk MSc.ss mcnt s . o r th e c s ti mntc J t imd inc

**dentili~ J**  in t h e PWP. un d n s uuun n r) ' of t he EPA' s rc.' SJ "W)U:-ocs t o t h os e co mm..:nt s. ' I his s cc ti on i s f o ll o wed by t he p lanned dat : 1 nct.•tk l'isk llSs c ss mcn lS cxrcc tc:d h "' be conduc t ed, nml t he

**rf lj~."Cted**  Rcgh.tr.uion He\' icw aimdinc fo r A:o:p . 'Q!.illu" f jJfH'ti . J .

**~t y.**  1hcrc

**~** n d i!:cussio n of ncs.l S ti!("' S . III 'II An:s

**Sll~Ct:** Tm ; PWP WAS I SSIIF.II Since the PWP

**\\ ~**  iuucd.

**~** new cnd·u.)(

**rrodu~t. As{Jt"r~illu.s**  flm • w , \1 · 36 l'rC\"3il (E PA Hc g i stra tion Number 7l69l·2) W:I.S r" gistcrc< l on lUll..: 25 . 201 5. h

**m:~~ ·**  

### be nrp1ic0 to cotton. com !lt

ld p is t nchio onl y in ccrtnin .s tal l!$ (ru l d for Cl"'I !IO n on l y in

**~crt in**  states nnd cou nti es (I( Ct 1li fom in ) 1(1 l imit t he amount o f afl; lto;.;i n p n"'duc\.'d by ot h

er s tr. ti ns nf

**Jh'r).!U/w ~**  flam , ,.,

**Durin~** the 60-d3y public rommcnt period on th e

**AJJ~rs:illu :c**  **jlm-u.~** PWI'. \\hich opened on Jull\.'

**2~.** 2015. :mel closed on ,\ugwl 24. 2015. the El'A f'I.'Cd\ ·cd one commcnl . ' l'ht: commcotcr. the
2I · II l<. .1 \

**End~ngcn**

**.' d**  Spccit"S Tasl..

**()t~c** (H! STF). indicated thou one of the r.:-g.ist . r.ln\5 of rroduct.s containing .r \ s pcq;_illu s rl:ln H \\:lS Q FESTF mc:-mlxr and 

### J:.,

**~ntilh.'<l** tO n:ly on FESTF dam for c:nd.mgcrcd species

**as.s.:~mcnh** n :l111cd t o this

**g.islmtion** rC\ • icw, The- EP, \ notes th is in r <mnntion is r etained in dtc

**.r\~l'ncy'.sli**

**cs .**  The E PA ::tl so solici ll "\1

**~om cn**  **s** o n t he s p cdfic t opics of

**n\' irLmm** 
**lu l**  j uMicc . w r u c r qul lit y co ncern s . ;s nd t rade irri t o nts , but n o c o mment s: o r

**nat io**  **n** w er e rcccin:d o n

**th o:-**  **~o •**  **~:, uc**  **s.** 1 \ t

**i~** t ime. no dat a g ap s

**(run cip.**  **ll~o 'i.**  **l** d. at a ncrds) for AJ ' fX ' 't:ill r t. \

j/m·m h3\'C be en idemjJ ie d. The m os t recen t cotnpn:hc:n s h ·c r isk as..<essn'lent tO r AsJNrgillusj1cwu.J ; \f36 was c ompleted on July J. 2003. :m d polcnti31 clli.-ct s rd ; ltcd to the usc 

# or the 1\:'cenlly rc:gi .s h:nd new product were

**ol~l ~onsidcrcd**  prior to its rt.); b tr Jtion. The most n . ''CCnt rhk asKSsmcnt (or

**~bp t•rgillrl5jlm**  **·us** NR RL 21SS1 w>s compklcd on July 17. 200-1 . I!I S J'

**ASSESS~ F.l'\T**  **S** FOI III E (; I STIIAT IO N RF.VIEW I n t h.;.• R cg i:.- t rJt io n

**R~\ ·ic**  **w** 1' 1\ • lim i n :u)' W o rk rl:lll (l ' \VJ_. ) l b r

**~pc il/;,**  **r.fl**

**.f ,**  th e E P t \

**tot~:d** t h

ut

,

**c~:.· aus**  **e** no d::Ha g ap s

**~: xis**  **:d .**  **~.:**

**t** o f nd d iti o nal ri s k a ssess ment s \\ O ulll n ot be nccc su ry. ns l(l n g as no prc \'io u :. l y u n

k n o 'm effects

**w~n!** idc util ic: d in 

### :1

**li**
**:s tu**  **c** s c .: uch . S i n ce; th e PWP w as p ubl b•h..: ll. the E P A h :1.'i con du c t e

d thi s li terature sc:m:h. T he

**~; ard**  **l** w as c on ducted u si n g mu hip le d:ttabJSCs o r collc..:t i On..'i of dat a b ases . i n

d u di r l b Tlmm so n Re u ters W e b of Sch:ncc . The search inc l u, l -cJ a ll ) ' C:J.r5

**~\ :tilnbk**  in C':lch d:uab35C, ronging from 1 960 to t he

**prc~m**

**.** S('.nth terms

**inchxh.-J·· hp,**  **r~il/usjlm u.r**  or '""atl.:UO'(in" 

### in combirution with c:teh of th..: (oiiO \\iog tcnns : ''bird . - "mamrml," "fi.sh.'' "inn·ncbrat..:," .. pl;mt," ··insect'' "arthropod . .. ".ar.u:hnid.'' " n:plile :· ilmphibian ... ··frcs.hw:uer.- .. m:trinc-

**.~·** -;,quatic ," ··cntomop:uhogcn .. :md "' bee." No r .:pons , .. ere found indic:Jting :.Jdi t ionJI cll "C-c ts that w .:r c not

**con**
**s: idc**  **n. ~**  i n pn:"ious 1

**i:-.~ .L'-:,.c:'~)nl**  **t'lll .**  O n D cccmbl'r 7. 20 1 5. t he EP A c o n ducte d :1 s-:m'Ch of I ! I"' A 's ECOTO X J at:lb.ls c (!lliJl : ll cr (' u . \l,cp :1.1.:<'\ '.'£. o,. 'Ol1)X/)

**u~i g**  

### a ht: lcnn s .. ASJJ l 'rKillm" :.'lnd '"jlamx, " bu t n o n e of a h .: so:

**u: m1**  **~ w~:**  **rc** f ou n d in t he c hcm kn l i n dex . The cllCc t s o f l bJ h ' rt ll/;, , , . j/

m • u

, , · i n

**\' ri**  **s**

**l'l gu**  **s** h : m: been \\ ' d l·c h : u

·u ch : r

i .,cll , n od t h es e

**11 ~c**  **s** w ere C l ' HI Si d c rcd i n prc\' io u s r i s k u

ss cs..'i m c r

us.

**Th~: ..:f**  **r..:.** c o ndu .s io n .41 f ro m pn :, · io u s ri s k as s e ss- m e n tS r c m :t in curre nt . :1.nd n n 

### u

d t

l i 1 ion: 1l ri s-k assessm e nt 

### i s no l nc:c c ss:s ry for Aspt>,.g i/lu. fj/ m·u s 

### stm i ns t \f. J6 nn d NRRL 2 1 8 82 . f: :-illOCfti:\"E EFFECTS .r \ s n."quin . -d

**b~** the .r\dmini)lrat or under the Fcdcr.1l food. J)rul: . nnd Cosmetic Act (H I><: A) ><<lion 408 ( p). 1hc El' • \ h» d<,dop<d 11>: Eml<Krinc

**Dim~p1or** Scrconing Progr:m1 (t! I)SJ' ) . :md has begun to

**implcmen th~:**  .)('rt:cning p rogram tha t is t o be u!;Cd ll) te s t nil

**itid~: .s**  i n ordc.·r 1 0 dete n n i r. e whe th er nrt:.in 5 ub s t.:mcc s (incl ud i ng

**p.:~ iciJc**  uct i w: and

**ot h~:r**  in!! r .. 

### ·di l.'ntS) may ha\ ' t: ;m -c ll C..: t 

### i n h u nuns o r

**wi dlil~**  **si 111i**  **.r** t o u n d Y' L 'Cl p rodu ced by a "'fl, llllrull y occ urrin g c s lrop. c n , o r

**ot ~r**  :: u c

h

**~, nd** 
**ri nc**  .: tT c

cts as th e A d m inis t r :llo r may

**:oi nate**  **."** FFDC ; \ s ect io n .J0 8 (p)( .J )

**au h)(**  **1"~** d1c A <.lrnini s t r. lto r . by on .l cr , to e x e m p t f ro m the rC'( J U

i r eme m s of t he Estroe:.cr til' Sub !ll:1 n..:cs Sc r rxn in g Program n biologic s ubs t anc e o r O th(..'r Js ub s tance if n determin a ti on i s nmdc thou

**th~** s u b s tnncl! is n ot an tic i p :ul! d t o J lrod u el! nny cnCc t in humon $ s im i l ur to a n cm:ctJ)roduccd by :' n:atu ro lly occurring cslrog cni c s uh s ttum: . Och\C:Cil October 

### 2009 3fld Fcbm;,..ry 2010 . the EP ; \

**~s ucd**  test

**ordcr ~.!**  **data** c:tll - in.s for the fir s t [:r o up of 67 chcmitob.. "bich cont:Wirl.\ 

### 58 pcsticidc 

### ' lc-1i\c ingRdicnl., n nd 9 incrt ingn:dicntli . A S(.Xo n d li:o.t of(hcm ica ls i dl!ntificd for EDSr sc n:-cning W:tS publi,hcJ on June 1.;,

**3.~** n ntl i ud udc.s so me p es ticides sc h e

duk'<l fo r r q;istr:u io n r c\' · icw ond c h c mi c:..ls found i n \\ ':ltcr . A . (fU 'rJ.:Uiu s flm · u s i s n ot : uu o n s t he sro uJ ' of pe st i c i

de n ct i\'c i n gn:d ie m s on t he

**li ~t.s**  to be s crcc ncll under th e EDSl 1 • The EPA . as p..1rt ofthis Firol Work l 1 l;m. bclic\'e s th : u , bpcrgiiiiL fjl cn , , , , is a sub s tun c c

**t~t** would n ot likely produce an)' etlCct in humans similar 10 nn cOCct product."<! by a naturall) ' occ urr i n

g eslrogc ni c

**ub stn**  **c~;.** t \ S s udt, pursunn t to Section 408(p){ 4 ) . th e EPA will de term ine i n the fu1Ur l! \\hcthcr it cn n exemp t , fsJh'f }:. iiiW ' }/(I nr , 'f fn • nnthc r cq u in: m cnt s of th e Se-c t io n

**~08 )**  ED:o; l' . I n the . eve nt the E PA d ocs detl.'rminc to exempt th is s ub s t; mc c i"rom lhc CD S I\ nn order \\ i ll be i s weJ . For furthe r infonn a l i on on the Sl3hl ( of the EDSP.

**th~.:** rolicics

**;~nd** rcocc-durc 5. the l is t s o f chl!mical s . futun:

**sL~.** t he tC$t

**idelincs** n n

d tht.: Tier I scr\."t'ning h:mcry.

**rJka..;~:** \'ish om web s i

te nt 

### b.ltc J :I/ ,,,, ,, ._ , .,11W:N t ' 1 l'mlo ' .
\Vl 1c n th e

**I'A** c o ndu c ted n nl.'t:ologicn l ri s k n ss e ss mcnt for " ' · 'fll'r g illusjlm· m t \F 3 6 in200 3 an d 

### Aspas:JIIm · j lm ·w · NRRL 2 1 882 in 200-1, th e Agency dete rmi ned th : 1t ndH•r s c

**cfl'~.:cts** 1 0 l h) llt nq ; c t organism s an: no1 ::tnticipltcd \\ ilh the J:\bcfcd uses ofproJu c u conta inin g t hi s :J.i . rcgistcn..·U ::t t that lime . Data from the o ri g iruJ rcgistr.ttion \\t:t.: cited to l" urron th e rcsi s tr

J t

ill n of :m additiorud produc1 contninint; ..bpagillus jltrm :c AFJ6 in 20 1 

### S. ond these c onclu s ions did n o t clun gc n s n

**c~u lt**  of the l nbc kd

**u~'S** of 1hnt product . **4:~4\t. t:**  th e U5CS h : 1w n c u been cxp nnd.:tJ si n e!! 2003. and th e EP ;\ is nw:uc of no : additi ona l n ontnf};ct cf l \!c t s th a t wen: II IJI p r

c, · iously

**con id~.:r**  **cJ,** t he c on c lus ions o f t he prc\ • iou .s ri sk

**:LSsc~s cn**  **l** nrc M ill c urrent. Si nce t he !; t •A ha s dctcm1inOO Uwt no ad\'crse effects " ill occur t o any nontfir !) t:t

**or~anism** ns:.. re s ult o f the J:thck·d a ppti cl t ions of A s

pas: ill llf

j lu\ ' u

s . .:ffcns t o fl"d.:rally·lisu:•d lhrc J. tctft.-d and cnd : m gcrOO

**f>'.~ s**  and their

**dc: igrt:ttcd**  **critic:~!** h.•bitaLo;; olso : uc n ol c ; \;pcctl!d . Therefore 1h.: EPA nnticipaiCS m::ak i n& n "No E fli.""Ct" Jctcrmi natio n unJ I! r the End:mgcn.'\1 Sp\!c i cs , \c l (ESA) l Or direct :.nd in d i rect effects to l i ste d S t 'X:ci c s a nd t h eir

**h:~bilnt s.**  If a ny :u.Jditi onal int O

nn n t iv n

**1"~Ct:o cs**  ;w:ti lr Jh lc. t h e n the EPA '' i ll consider 

### it. T h e 

### EI )A h.l S t:rc:ttOO the folltm · in g C' St im atcd t imet i nc for the complcticm of

**h~** R q;is trnti on 

### R

c\'icw l b r t t 5

p( ' Q:Uinot flt H'm .Rtl! i "r:ation R tview for l bf"·rgllluf}ltn·us . Proj «t <'d lt <-gL, t r.U ion Rr , · i <''"' T im tl in C' 1 \tlhi ti H 

### l f.5 tim :UC" d M o nt h/ Y e- ar Q p

_ t ni n" tb t O o tkd Open f)cx;kcl and 60·day Pu blit.: CC'm mc:n l Period for

**Aspt ·r~**  **i/lu**

**·** J une: : 01 5 - Completed llfn·m ·

**(.' ..,~~;**  Pub l ic Co mmcn1 l' cri Pd t \ u 1;u1 1

**~0 5-**  Com plctc J C u s c Dl'nlo pm tnl

**S..'i ll**  **~** Fin:tl W ork P l a n l}.•cc:mbc r 

### :!0 I S-

**Com kl~**  **d** ls.'iuc

**~t:t** Cnll ·i n N ' ; \ Oau

**ubn i~io**  **n** N ' A Open 30-d.l \ ' Public Comment Pe riod (or Dr.tft R isk t \ SSc:ssmcnls S ' A C.:I0\4: J»ublic Commcnl l'.: riod S l , \ ll t'C. i s lrnti o n l tc- , · icw Dc cil i on Open 60·dJ y Pub l k Cc unnu:n t r •criod for Propa sc d R eg i s tration

**~b cb**  

### : on Hc\' ic w Fin:. l De ci sion

**Cln~** Pub lk Co mmen t

**P~rioJ** M :t) 20 1 7

**rh: !lli(l**  **n** R C

\ ' i

cw

**n:t. IJ~.·d** 
**:.: n**  : m d O cg i n P os t - d c d si<t n Jt.mc: 2 0 1 1 (I(I IJ O W•UP To 1 ul \' to rs " 2 

# . . . .

Thh. Jeh,."\l, • !o: . , )Ubj «t to tC\l'l i OO \h C •uiJ

**n(orrs~m** 1 .uues n.nse d11t1n& the

**Mf~htruuon** Rc:Hc:\\

**proc~s,**

**.** I n

**h~** tHnl ll R t \ \uo:

**.:ui~o<)** . .)IXb ;,u l bc

**f~•luu** w

**:K~ uitc-**  :ar1l:.OS P C'\t' mptioft, lh <n :.n a rncnd< d FWP , .... 

### u bC' i.uucd ; u l h."l ll t mc llu: fWP

**\\ill dcnhf~**  lln)

**nc~** I ) rloann<"d dau l'!«dl Uld set forth :a nc\\ IIIDC' I II'tc , :\EXT STE I ' S 1 \ S n o t cd p r c\' ious l y . t he E l 1t

\ wi l l

**dc l)~**  wh et her . p ursu : mt t o

**S~:ct on**  **(rX )**  of th e J :' cdcrJ1 Ft)O J , Drug. a nd Co s m c t k 1 \..: 1 . **pcr~Uius** j1 a \ 'IIS q u nl ifi..: !l> l i.Jr

**~·:<l.'mp**
**io n**  f r

om t h e E D S P . 

### · n is d eter mi nati o n 

### '' i ll i n l'

unn th c Age n cy ' s t i na l n : gi !"t r n

t ion rc \· i c w de ci sio n .



### 5