llo<:kct Number EPA-HQ-OPP-2015-02SI 

www.rcgu1ations.gov 

Aspergillusjlavus 

Final Work Plan 

(PC Codes: 006456 and 006500) 

Registration Review 

C:1se Number 6008 

Decem be a· 2015 

Ap proved by: 

gl·':~j Robcrt McNally. Director 

13iopcstic idcs and l'ollulion 

Prevention Division 

Date: 
I i\'TIWOUCTIO 'i 

I his is the U.S. En\'ironmcntal Protection ,\gcncy's (EPA) Fin:tl Work Plan (I:WI') for the 

Rq;istr.llion Rc,'icw or bJ~t r'J,;illus jlnrtts. 11liS F\VI' fOllows the l)n:l imin:uy Work l)lan (PWI') 

posted in llw Rt:!;i:>tr:ulou ltc"icw dockcl for 1.\p,·r~Uius jlm·u.'( (EJ•J\.JIQ·OPP-20 15-028 I). 

TIH\~C products (ouc m:mu1:1cturins usc and two ..:nd usc products) Jmvc hc~u n:sistcrcd that 

contain eithe-r oft,,n strnin.s of Asprr~UIII.' jlm·m :u nn acti' c inf:rcdicnt. 11u: end u..;c products 

nn! registered for uSC' to coutrol atl:uoxin·pnxtucin~ fungi on co114:'n. c:<'m. pist;Khios. nnd 

pc:.anuts. ;\11:uoxins :m: n.Jturally occurring mycotO.\in.' produC\."'\1 by some: ~trJ.ins of rs:11lru 

Jltn't6 and arc among the mo.st can:inog~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 rcsistcm:l products do not procluc'-' nfl:tto:\iJU, nu:~~ strains :m: 

~;pagillus jlll\'IIS AF.16 hlu.l A.,fNrJ;illliJ jlm•u:t NRRL 21882. .o:pL·r~illm· jlm·110: t\F36 was 

isol;:ucll in Arizona 11nd is OllSO found in Tcx!ls, while J~t:rgillfls jhn•u,,· NRitL 21882 wns 

isolated from n pc:111u1 $ecd in Georgia. When llJlJl1h:d to conon. corn. pistnchiv. and peanut nt th..: 

ri,;.httiml! (p•cbloom). the:sc ~troins of Aspugillus jlm·,JS arc cxpcc.tcd to di:r.rlacc the afl oxinproducing str.Jins Of 'Jh'f}~illus flm'U.o: from the uop ;md lid d. 

The UP1\ is implcmcntin~ the Rq;istr.nion Rc\·it\\ progr;1.01 pwsu:mt to S\."Clion 3(S) oflhc 

Fcdcrnl lnsccticidc. fungicide. and Rodl.!'nticidc Act (FIFRJ\) :1nd \\ill n:\·icw each registered 

rcsticidc c\·cry 15 )l!.tr1' to Jcccmlinc whether it continues to meet the FIFRJ\ standard for 

rq;istr.ttion. Chanscs in scient<.·. rublic polic~ . nnll rc~t llL' usc pmcticc.·s (IC~ ur (l\'Cr time. The 

l(q;,istration Rcvic.·w JUOa;r:un is intended ~kc sur..: that. Ol$ the :tl'lility to :1ssc.·ss ri$k c\ \'~S 

and 11.~ J>OJicics and rrncticcs change. all rcgistc:rcJ pesticides continue tomcct thc stntulof)' 

:stand:trd of no unrc:uonnblc odw rse cff ... ~ts to human lu·:ahh or the cn\'iromncnl. lltc Jlublic 

phase of Rcgistr.uion 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 

substanti\'C comments r~;.'<'civc..J . if any. during the public conuncnt period for the PWP 

~.:ouc,·rn ng anticip:m:d dmn needs, cxpccl'-'<1 risk MSc.ssmcnts. or the cstimntcJ timdinc dentili~J 

in the PWP. und n suuunnr)' of the EPA's rc.'SJ"W)U:-ocs to those comm..:nts. 'I his scction is followed 

by the planned dat:1 nct.•tk l'isk llSscssmcnlS cxrcctc:d h"' be conducted, nml the rflj~."Cted 

Rcgh.tr.uion He\'icw aimdinc for A:o:p.'Q!.illu"f jJfH'ti.J. ~t y. 1hcrc ~ n di!:cussion of ncs.l Sti!("'S. 

III'IIAn:s Sll~Ct: Tm; PWP WAS ISSIIF.II 

Since the PWP \\~ iuucd. ~ new cnd·u.)( rrodu~t. As{Jt"r~illu.s flm•w ,\1· 36 l'rC\"3il (EPA 

Hcgistration Number 7l69l·2) W:I.S r"gistcrc<l on lUll..: 25. 201 5. h m:~~· be nrp1ic0 to cotton. com 

!ltld pistnchio only in ccrtnin .stall!$ (ruld for Cl"'I!IOn only in ~crt in states nnd counties (I( 

Ct1lifomin) 1(1 limit the amount of afl;lto;.;in pn"'duc\.'d by other str.tins nf Jh'r).!U/w~ flam,,., 

Durin~ the 60-d3y public rommcnt period on the 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 

2 
I· 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\ spcq;_illus rl:lnH \\: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 to this g.islmtion rC\•icw, The- EP,\ notes this 

inr<mnntion is retained in dtc .r\~l'ncy'.sli cs . The EPA ::tlso solicill"\1 ~om cn s on the spcdfic 

topics of n\' irLmm lu l j uMicc. wrucr qullity concerns. ;snd trade irritonts, but no comments: or 

nat io n were rcccin:d on th o:-~o• ~:,uc s. 

1\ t i~ time. no data gaps (run cip.ll~o'i.l d.ata ncrds) for AJ'fX''t:illrt.\j/m·m h3\'C been idemjJied. 

The most recent cotnpn:hc:nsh·c risk as..<essn'lent tOr AsJNrgillusj1cwu.J ;\f36 was completed on 

July J. 2003. :md polcnti31 clli.-cts rd;ltcd to the usc or the 1\:'cenlly rc:gi.sh:nd new product were 

ol~l ~onsidcrcd prior to its rt.);btrJtion. The most n.''CCnt rhk asKSsmcnt (or ~bpt•rgillrl5jlm·us 

NRRL 21SS1 w>s compklcd on July 17. 200-1. 

I!ISJ' ASSESS~ F.l'\TS FOIIIIE(;ISTIIATION RF.VIEW 

In th.;.• Rcgi:.-trJtion R~\·ic w 1'1\•limin:u)' Work rl:lll (l' \VJ_.) lbr ~pc il/;, r.fl .f, the EPt\ tot~:d 

thut, c~:.·ause no d::Ha gaps ~: xis :d . ~.: t of ndditional risk assessments \\Oulll not be 

ncccsury. ns l(lng as no prc\'iou:.ly unkno'm effects w~n! idcutilic:d in :1 li :s tu c sc.:uch. Since; 

the PWP was publb•h..:ll. the EPA h:1.'i conducted this literature sc:m:h. The ~;ardl was conducted 

using muhiple d:ttabJSCs or collc..:tiOn..'i of databases. ind udirlb Tlmmson Reuters Web of 

Sch:ncc. The search inclu,l-cJ all )'C:J.r5 ~\ :tilnbk in C':lch d:uab35C, ronging from 1960 to the 

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 :.JditionJI cll"C-cts that w.:rc not cons:idc n.~ in pn:"ious 

1 i:-.~ .L'-:,.c:'~)nl t'lll . On Dcccmbl'r 7. 2015. the EPA conducted :1 s-:m'Ch of I!I"'A 's ECOTOX 

J at:lb.lsc (!lliJl:llcr('u.\l,cp:1.1.:<'\'.'£.o,.'Ol1)X/) u~i g aht: lcnns .. ASJJl'rKillm" :.'lnd '"jlamx," but none of 

a h.: so: u:m1~ w~: rc found in the chcmknl index. The cllCcts of l bJh'rtll/;,,,.j/m •u,,· in \' ri s 

l'l gu s h:m: been \\'d l·ch:u·uch:ri.,cll, nod these 11~c s were Cl'HISidcrcd in prc\'ious risk 

usscs..'imcrus. Th~: ..:f r..:. condu.sion.41 from pn:,·ious risk assess-mentS rcm:tin current. :1.nd nn 

udtli1ion:1l ris-k assessment is nol nc:ccss:sry for Aspt>,.gi/lu.fj/m·us stmins t\f.J6 nnd NRRL 21882. 

f::-illOCfti:\"E EFFECTS 

.r\ s n."quin.-d b~ the .r\dmini)lrator under the Fcdcr.1l food. J)rul:. nnd Cosmetic Act 

(HI><: 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 program that is to be u!;Cd ll) test nil itid~:.s 

in ordc.·r 10 deten nir.e whether nrt:.in 5ubst.:mccs (including p.:~ iciJc uctiw: and oth~:r 

in!!r .. ·dil.'ntS) may ha\'t: ;m -cllC..:t in hununs or wi dlil~ si 111i .r to un d Y'L'Cl produced by a 

"'fl,llllrully occurring cslrop.cn, or ot ~r ::uch ~, nd ri nc .:tTccts as the Administr:llor may 

:oi nate." 

FFDC;\ section .J08(p)(.J) au h)( 1"~ d1c A<.lrninistr.ltor. by on.lcr, to exempt from the 

rC'(JUiremems of the Estroe:.crtil' Sub!ll:1n..:cs Scrrxning Program n biologic substance or Oth(..'r 

J 
substance if n determination is nmdc thou th~ substnncl! is not anticip:ul!d to Jlroduel! nny cnCct in 

humon$ similur to an cm:ctJ)roduccd by :' n:aturolly occurring cslrogcnic suhsttum:. 

Och\C:Cil October 2009 3fld Fcbm;,..ry 2010. the EP;\ ~sucd test ordcr~.!data c:tll-in.s for 

the first [:roup of 67 chcmitob.. "bich cont:Wirl.\ 58 pcsticidc 'lc-1i\c ingRdicnl., nnd 9 incrt 

ingn:dicntli. A S(.Xond li:o.t of(hcmicals idl!ntificd for EDSr scn:-cning W:tS publi,hcJ on June 1.;, 

3.~ nntl iududc.s some pesticides scheduk'<l for rq;istr:uion rc\'·icw ond chcmic:..ls found in 

\\':ltcr. A.(fU'rJ.:Uiusflm·us is not :uuons the srouJ' of pesticide ncti\'c ingn:diems on the li ~t.s to be 

scrccncll under the EDSl1

• 

The EPA. as p..1rt of this Firol Work l

1l;m. bclic\'es th:u ,bpcrgiiiiLfjlcn, ,,, is a substuncc 

t~t would not likely produce an)' etlCct in humans similar 10 nn cOCct product."<! by a naturall)' 

occurring eslrogcnic ubstn c~;. t\ S sudt, pursunnt to Section 408(p){4). the EPA will determine 

in the fu1Url! \\hcthcr it cnn exempt ,fsJh'f}:.iiiW'}/(Inr,'f fn•nnthc rcquin:mcnts of the Se-ction 

~08 ) ED:o;l'. In the. event the EPA docs detl.'rminc to exempt this subst;mcc i"rom lhc CDS I\ nn 

order \\i ll be isweJ. 

For further infonnalion on the Sl3hl( of the EDSP. th~.: rolicics ;~nd rcocc-durc5. the lists of 

chl!micals. futun: sL~. the tC$t idelincs nnd tht.: Tier I scr\."t'ning h:mcry. rJka..;~: \'ish om 

website nt b.ltcJ:I/,,,,,,._,.,11W:Nt'

1

l'mlo'. 

\Vl1cn the I'A conducted nnl.'t:ologicnl risk nssessmcnt for "' ·'fll'rgillusjlm·m t\F36 in2003 and 

Aspas:JIIm·j lm·w· NRRL 21882 in 200-1, the Agency determined th:1t ndH•rsc cfl'~.:cts 10 lh)lltnq;ct 

organisms an: no1 ::tnticipltcd \\ilh the J:\bcfcd uses of proJucu containing this :J.i. rcgistcn..·U ::tt 

that lime. Data from the origiruJ rcgistr.ttion \\t:t.: cited to l"urron the rcsistrJtilln of :m 

additiorud produc1 contninint; .. bpagillus jltrm:c AFJ6 in 201 S. ond these conclusions did not 

clungc ns n c~u lt of the lnbckd u~'S of 1hnt product. 4:~4\t. t: the U5CS h:1w ncu been cxpnnd.:tJ 

sine!! 2003. and the EP ;\ is nw:uc of no :additional nontnf};ct cfl\!cts that wen: IIIJI prc,·iously 

con id~.:rcJ, the conclusions of the prc\•iou.s risk :LSsc~s cn l nrc Mill current. Since the !;t•A has 

dctcm1inOO Uwt no ad\'crse effects " ill occur to any nontfir!)t:t or~anism ns:.. result of the J:thck·d 

appticltions of Aspas:illllf j lu\'us . .:ffcns to fl"d.:rally·lisu:•d lhrcJ.tctft.-d and cnd:mgcrOO f>'.~ s 

and their dc: igrt:ttcd critic:~! h.•bitaLo;; olso :uc nol c;\;pcctl!d. Therefore 1h.: EPA nnticipaiCS 

m::akin& n "No Efli.""Ct" Jctcrmination unJI!r the End:mgcn.'\1 Sp\!cics ,\cl (ESA) lOr direct :.nd 

indirect effects to listed St'X:cics and their h:~bilnts. If any :u.Jditional intOnnntivn 1"~Ct:o cs 

;w:tilrJhlc. then the EPA ''i ll consider it. 

The EI)A h.lS t:rc:ttOO the folltm·ing C'Stimatcd timet inc for the complcticm of h~ Rq;istrntion 

Rc\'icw lbr tt5p('Q:Uinot fltH'm. 
Rtl!i"r:ation Rtview for lbf"·rgllluf}ltn·us . Proj«t<'d lt<-gL,tr.Uion Rr,·i<''"' TimtlinC' 

1\tlhitiH l f.5tim:UC"d Month/Ye-ar 

Qp_t nin" tbt Ootkd 

Open f)cx;kcl and 60·day Publit.: CC'mmc:nl Period for Aspt·r~i/lu · June: : 015 - Completed 

llfn·m· 

(.' ..,~~; Public Commcn1 l'criPd t\ u1;u11 ~0 5- ComplctcJ 

Cusc Dl'nlopmtnl 

S..'i ll~ Fin:tl Work Plan l}.•cc:mbcr :!0 IS- Com kl~d 

ls.'iuc ~t:t Cnll·in N';\ 

Oau ubn i~ion N'A 

Open 30-d.l\' Public Comment Period (or Dr.tft Risk t\ SSc:ssmcnls S 'A 

C.:I0\4: J»ublic Commcnl l'.:riod Sl,\ 

llt'C.islrntion ltc-,·icw Dccilion 

Open 60·dJy Publk Ccunnu:nt r•criod for Propascd Registration 

Hc\' ~b cb :on icw Fin:.l Decision 

Cln~ Publk Comment P~rioJ M:t) 2017 

rh: !lli(l n RC\'icw n:t. IJ~.·d :.: n :md Ocgin Post-dcd si<tn Jt.mc: 20 11 (I(IIJOW•UP 

To1ul \'tors " 2 . . . . Thh. Jeh,."\l,•!o: ., )Ubj«t to tC\l'liOO \hC•uiJ n(orrs~m 1.uues n.nse d11t1n& the Mf~htruuon Rc:Hc:\\ proc~s,. In h~ 

tHnl llR t\\uo: .:ui~o<) . .)IXb ;,u lbc f~•luu w :K~ uitc- :ar1l:.OSP C'\t'mptioft, lh<n :.n arncnd<d FWP , .... u bC' i.uucd ;u 

lh."llltmc llu: fWP \\ill dcnhf~ lln) nc~ I) rloann<"d dau l'!«dl Uld set forth :a nc\\ IIIDC'III'tc, 

:\EXT STEI'S 

1\ S notcd prc\'iously. the El

1t\ will dc l)~ whether. pursu:mt to S~:ct on (rX ) of the 

J:'cdcrJ1 Ft)OJ, Drug. and Cosmctk 1\..:1. pcr~Uius j1a\'IIS qunlifi..:!l> li.Jr ~·:<l.'mp ion from the 

EDSP. ·n is determination ''ill inl'unn thc Agency's tinal n:gi!"trntion rc\·icw decision. 

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