fungicida fenbuconazole capsicum 00399238

7/30/2019 Fungicida Fenbuconazole Capsicum 00399238

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Se pone en conocimiento de esa institucn que nuestra Embajada en Washington hainformad que [a Agencia de Proteecn del Medio Ambiente (EPA) de los EstadosUnidos, ha publicado recientemente en el Registro Federal de ese pais, a travs delDocket (documento) NEPAHQGPP-2012-0520, que se adjunta al presente, lanorma fnal que establece tolerancias de residuos para el fungicida Fenbuconazole ysus metabolitos en Capsicum (pimientos y ajes} segn se detalla en el contenido dedicha norma.Esta norma final ha sido emitida en e! marco del ttulo 40 del Cdigo de ReglamentosFederales (CFR}, parte 180, as como de la Ley Federal de Alimentos, Medicamentosy Cosmticos (EPOCA}. Cabe resaltar que esta norma entro en vigor e! 03 de julio de2013.Segn lo indicado en la misma nrma, EPA puede recibir objeciones y solicitudes deaudiencia hasta el 03 de setiembre de 2013, para lo cual se deben de seguir lasinstrucciones consignadas en el ttulo 40 CFR 175, disponible en e! siguiente enlaceelectrHico:

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~ ~- =sticid~'s tc - .. -tti..~,icalil...~~ F~rIC } I~-iy 'zg l~~t-~~. ice: , ;, tif~e sz y_ , ,Ol:'~ V i.f.~_)1T11' E.` f ~ - -R ,:Ff~~~ 1 ~ ~:F ; " L ' 'ls llo ap(Iri:~sl:, thF; toxl~ )~t)~3calPO D is usc,cl as the l~asis for de` . i t ) Ilol re;fer~llce ~-altles fo r risk assc , ~ , s = : ~ : ; - ..1'(~Ds 1rF~ de~~c:lo ~etl i)asFzct oll a c}ret~tlanalZ~sis r.~f tl,:, cosE)s irl eacllt(axicolo~i(. ' , ;,:'~, tc, citrtermint> tlleclE.)sc? at ~ti-1lic:h ;o adc~E'rse cffc~cas arreC3bst?rr'ed '.' ` --~ 1 7~~EL) an the lo~~'estCl.OSe af.. _ . ~-. ~~+~~ ~.~ ~ ```. -: t lf C.Ot1Ca'TIZ',-, LC3,~`... L .0>ertai.n.t~r/r~ i:...,+..,.,S11C;t;: ?t!_.; ;J Lts~ iii ~ ~.Lir1Gt70I1ZNlt,l:l ...., ...~ tC) C; 8.1C1,3.l.at(?c . ` ~ F,E?xf~o suri l~-~:~1_ generall~~~ :..~~:rr~d to asa pt~~ulatiE~~~- ~~->tc~d closc:? ,~'~~D} ur arcfer,~,lcc (:tos,- ~))alld a. saf`(~ 1nari.1T.of'~ ;~:'~3r(? (Iv1C.:~.;. i'nr non-tllresholclTl~::, ~i1G r~bellCy" aSSlt711eS tI1Ll:t :}Il['nr..,c.,:~ of c~xl) sllre tivill Ieacl_ to sr_ 3nlc~):,: of risk. `1'hus g t h c ~ ~i?E?nci~e ~ , ~i:_}ates risk in terr7 14 of `?1e p c..,~t ';ilit}re . : ~ ~ . ': : '~ . ~ i l i a I . i _ f c ? t i p l e . i or m c) rc :,i71s,)rL~}~:.~_1 an thF: ~e:ticial I~ririci~les1 ? 1 3 .: i ;} ~isk. charactF~riz2tia3.l. aarl a.co711p.ie# d(>:,cri~tall of the riskasscssll:-~.. ;; oc.,~,;, s(~e Ilttp://bVt6'b1~.P1:CL~,;:~+: ;.'-.?~.;If~f;S~~CTC~512(~E?tS/II~~;.ISSE.~. . i ~ . i ~. -`1 Slt'IIL'IIl~~i"' 0'~ thC?...;,;ut:c.::~:=,::;.:~,.. u.SF'd fo r .r ._....:)riskass ~:>str:.~ ,' i ~ sll.cnti~n in `l :i rIe 2 of tllis!.lnit. the t.oxir:olt)~;icalent .._i.-:~ for _~ub tic~c)nz~olt~ ~used fo rt 1 ~ , 3 . . _ E i r r i s k ; ~ , , ; ~ ~ ; 5 5 1 1 1 F ; 1 1 1 : is sha~lTni11' 1 ' f . : ~of this Lt ni t.TABLE 1 SIJMMARY t~F T K E C L C ~ G IC A L Q Q S E S A N Etv DPINTS FR FENBUCO(~AZC7LE FR USE i~ 1 -i U M A N i-1 A(wTH ~iiS KASSESSMENTExposurelscenario Point of departurefl~, PAQ, LC~C foand uncertainty/ ~ risk assessmentsafety factors Study and toxicolgical effects

N O A E L = 3 Q m g lkg/day.Ut-, 1 = 1 C3xUF f , = 10xFQPA SF = 1 x

Acure Rfa = 0.3~evelpmenta( rat ~.~~_ .: yn}g/kg /day.QAEt_ = 75 mg/kgr _~ ~y based on increasedaPAQ = t3 .3mg lkg !ostimp(antatlon icss and decreased lisdaydam.Acute dietary (Femafes 13-49 years ofage7 .Acure dietary (General ppulation in-cluding infants and children}.

sarptions,eses per

~ne ..a .................1tone .,..,_,.....ti........ ; Not selectedt~o appropriate single doce and endpoint could be identi-fiied for these papulation groups..Chronc dietary (All populations} ....,,..,,,. f~!AEt_ = 3 mg/kg/ Chronic RfQ = 3).3 Combined chrnic toxicity/carcinogenicityRatd a y .mglkg/day._AEt_ = 3C3.6/43.i (M/F} mg/kg/day based on decreasedUF ; , = 1 axcPA_ .3 mgl dy weight gain, increased thyroid weight, andUF E { = 1 Qxgr'dayispathological lesions n the liver and thyraid gland.FQPASF =1x


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Pont of departuref , P A D , L C f o rand uncertantyisk assessmentsafety factersE ;~~.~~~~`_~ `scenaro Study and taxicological effects

Under the 1986 cancer classifcation scheme, fenbuconazole was tlassfied as a Group ~PosibleFluman Carcnogen, vvith a !aw dose extrapoladn model appGed tQ ~ e animal data for the quantfita-tion of hun;an risk (Q, 5 ). This tlassdcation was based on a statistc~!, :ignfcant increase in com-bined he,~~~antellul~r ~`:.nomas andfor carcnmas by par-avise c., r, ~r.,,san wth conturrent cEantrols,and s ~-1~-~


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Fei.~.eral IZeg pster l ~ t , ' u I . i ~ ~ , ~ t i ` a . 1 2 8 l ~ ~ 1 ~ ~ e d n E i s d a y , ~ J u l ti t013 / I2u 'l~s and P.egttiations0~2`i, t.~':;..,z::t~I'IiPS.t'tlt.ie,s ofI ~ ' c n t ~ ) ~ ~ ~. ~ .) 1 c ~ ~ i n ~ e 1 ~ h c ~ r ; s " (doc;kct I~nun1): '-lC:~-C).PP-2[l1'?-O~i2(i).1~. 5:.':"y~ I~'actor forinftznts c c z z c l

I ' I i D C , A ~ -,.l' , :t l ~ , : t_ _ ~ s : ; .1 1 l a P 1 1 I ~ ~a n a d ( : l i " ~ ~c.~....:' ~)l~. (1Or) ~:-larb in o fstl'et~:' :E:" it,; llla - ~~rlcl chilcllcn in thccasa af t'Ireshok _'. !-)1'fects to acco~un t forprerltl.t~ 1 ..:cJ .:..; toxicit~~' t.;1.~9 th.Econh;l(:;f'_, ;~ ,.l: d-, .11=.... . ,_ _ .`Ccit~- - .aIlcl 1;:pi)st1l'i rll:SSS ....._'~'. dE'tCir:~....=C.,,,1JaSE' C1 re la 1 e C a t < ! i , . : 1 : ` a c i .f f t~ ' ~ ~ ' n tnlarill af' safet~= ~ il.l be rafe fc~. t- ':_n tsa l c11ilElrEall. "l, klis ad (':.`fanal llct~'~,i . , ~ ,fs;, ' is colnm .onl~,~ 1:;i=:~rr=:~:cl to ~rs (lIe. _ 5al~c,+r.= I~ artt,r (~ ~ '). :.1 a}:)114 i1.ld-~:'~C)V15:E)Il, EPt3 Lli'1E?_' 1'BtalI15 C h ei _

'1''~~:~il~:~i?l't~i t`al" 1DY, (~`: ,....... :a Cl.iffP,:rE'Tlt,.adrlitiar ~11 s~llet`= E'ae,'len r E = u ( 1 . 1 ) I E ~d:~f-lec=el resi~uE)san ,.' som e; a' . .....1t} lev els fro mc:rop field t .rial~~ lc


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~ ~ 3 ~ 1 2 Gf ~derai P e~lster / ~ ~ r ) . 1 . 7S, `rz. 128 / t-~~ec(nesda~~, Ju~~~ ~, 2013 l hules and R~~ulations~uhi c ., h. r;" ~;: . 1 . 3 . b c ~ o r : . ~ : . ~ : . :c ' ,the CC)':t.~:'.F"': tI' c' .,_:; C)[ lCs %1'-CtC)S C 'llE'lrE'.CtTaliol'ei."il, iiilii ile ro1II1CI11'1f.Tpro ceclur r; r~!.t:sczik)ecl. in thi.s unir, cal.3corrisk should ~;ESno rally llot 1)e assurl3ecl tc)e~c:eed tll~ ~)E~rlcllnlark lt;..ss:1'es l d i7er7lt~t:had5'i~E~pcf.~;ov.13. Intc~Inc_ it~nr.11 ~~c-;sidtle~ Li177its

,~In rrl:; .;~ ii:; tE) r~ranccl cec isiozls, ~Pr~seo.kcs to 1 3 ~ rllcln:izE} L.J.S. tal ': - :l.nces ~l=ithirlternatiolltll standards ,'llc~:_~~ ~:~r-', lE~, col3.sist:ellt ~ t i ~ i t . h U.; . -focal~ ~~ standards and il r~ict,.lt urcll1-w~_._er:es. IJI'~~ collsiders tlle~ini r n a . ti o n a _ l n l a _ x i r l l l. i. l n r r ~ s i c l u c A l . i. l :z l _ i t s( I ~ ~ 1 1 : L s ) E : ;s t a l) l is h t ~ E : l 1 ) ~ t ll c z C : o d r xr l l irnentaritls CE)m znissior3 (Co do :}, asreglli.ra?cl 1)~~ :FF~'I~C.~1 sectioll. 4U8(h)(4)' I 'h~ Co clE3~ Alinlentarius is 1 1 jointU111tc'd ~iatlOnS I' C1od and 1~~T1CLtltttrC?C ) r ~ a n i z c l ti o n i t 1 ~ o r l d I - ~ I ~ t ~ a - 1 1 6 .C ) r g a n i z ~ : l t: io n f c m d s t ~ l : n c : l a r c l s p ~ E ~ ~ , : t ~ .. ~ . .1 1 r 1 d lt 1S ~L'CC)~Ill.L:GCIcls arl 1r1tC'.1'na:,Jrlcllfoo ci s~'~~ sta.l3darrks-settir:OI ' i7 ctil:~;i1U11 1_tl traikE' ~l n l'~ .,..~,nFhicll :11e L?nitEck Slales is ~ 1 _~. :, ~~,Pr~.n1aZ' eatak~l.zsh. 'rl I: O - ~.C1ci_I1.CE t-~', . ts ~ d l f t E ; r e l l t . f r o n l a C ; o t : I e Y ~ ~ i : k ~ C , ; l l . t ) t ~ E , ~ ~ t : ~ : r ,1=h'~DCI~ sectiorl 40t3(kl)(=) Terltrires that

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iYC',Il.hl' ,~. :~:i:i,:pn131. ' ~ ~ ~ 1~1I~ZL is d '_~..f c : l + . ~ ~ t : ~ : = . _ : e s i a ~ b l f s . k l E , d ~ ` J T ;clrll~uconazole.,, ....~ t?nitod. Statels. `I'lle (~:odo ~ V IR.[s l'orp ~ - ~ ) c : ~ t ~ ~ = ~ a ~ n3o5t Iikel)~ E)stk)IishE~dh -- )re thca 1;nable `?I< ' farmtllation iraspropc)soc~! for n.sc~ on. ~leppE~rs ~lndinc;ludes on1tiF resclur~s of thE) parc~ntcol7 lpou ~nd. This n+:?~.~~.- fc)rmt11.:l.tion has1 1 . i. h E : z r T c s i d t i .e s ~ ~ - ~ . l .. c : = . r ~ ~ n ~ ~ t .. ~ u ) to ().7pl)I~;1, and tho ~[.1.5. 'C:erancE ;ItckttclEat':.?!~ --:o lacton e lnerab olites.,.rl3oni:ration ~ . ~ T i t h t h E ~ 0.6 ppllltoh~,ra.ncE~ is Ilo t .f'E:~asil)le i~~en theproliosed I:=c;:=:~ use patteln/formtllationa.nd tilo ohs~-~.rved :rosi.dtle .le~~c~ls.C: iies~JO .rlse, to Cvn~l_r rler.ItsEl'r~ recE,iE=~~?. i corzz nlant to fh.e no tic~c:of filinf; t-~rhich 5,:c~ ;'lat residuo le~~elso ` ' f ; - con azol. ' shou ld not 1)c rai.scd.` ~ , .1 - : 1 9 u n c l E > r s t a l 3 E l s th E .E I ] _ Exrl~c)r's cancerrls and rc~co nniLest:hat som E~ incli~riduals be liet~e thatpc)sticides ~.?'o uld bc; barlrleck 3I1a;ri.cul t.tlr~' corps. Howover, the existin~letal fr~lrz: ~;'~ pro ti~~idc,d b ~ ~ sE~ction4013 clf the .;Elral I~'oo d, I~ru~, al:ld(:;osn3etic Act (I'l''I7C:~~) s :1:gis th

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~ I ' 1 7 1 s 7GtlUl1 CIC11',: i::3t 1I1'~rOITrE" 1Ia;!j.'.'C.i7n1C'.,,.,~x~~k}-c,b,,~,.,-,'xi>Ixcl-3-(1I- i~ - 1.,:.~. ~c,:. '~_,,)Ix~~Ile.Ilit.Iile, a:ndits rrl.c~lj.,~_.i~.,s ': -~,1.2~1, cis-5-(=1-chlol~o ~s;~^zxt'k}- c' ill;clro-,:3-k~lx~~x~~f.-3-('1.I - I-furar7olle, Il~:lca IZI-I-.' 30, trans - 5 - (~-c k x l c - s r o l ~ i , r :~ ; ~ - ' ) - c k _ i h ~ ~ c l l ~ I ~ ~ - 3 - k ) I : l e 2 r ~ ~ . 1 . - 3 - (1 I - : I -1, 2, ~-tiaia.~ c; s e-1=~rllnclth~~ 1}-2-3 I-f1lralxorle, cai~.: ~zlatecl as tll.estoiollion" ~:"ic E~;cktlivalc~Il.t o~l'#E'IxlttC;C)n~';'.'~!;: ~!< OI` t)n. tl7t' .i~011Q1=1'1I1I1hI'ictllttFTltl COl'nr2'lOCli:tics.

Pepper.................~.................0ENViRQNMENTAL PRC)TECTIONAGENCY40 CFR Part 1 SO[EPAHQ UPP-2112-0291 ; F 21U.S.C. 3~6a, an~r Izersc,sl i_ ~ "~. .~." " anr~I~}k)jECtion to all.t~ aspcct o~ ,.~zi~ :~ftLlationa.lad l7xa~ct also r~q"rlest a 17c:~arilx~ on thoseobjections. ~'ou nrtlst Pile ~~otlr o )jectonr ~ I regtl~st ~. kxeari.I7 ; n taxis 1~~~tli.atioll.in z~.corck ance tti~ith tl~xe instr}_lctionsI > r o v i .c " k ~ ~ c k . i n ~ 0 C I ~ ' P , I)art 173. 7o cnstlreF ~-,.,r rI -' ~ i't. h~. EP,~., ~'ol.I. r z x " u s t .; _i~ z'i~ doc' ': iD ntlml~cr E:Pa~I~IQ-UPP-2012-0201 i}7 the stlbE";ct liase ont xe fi.rst ~,, _~ " o~ ~~ otl r su_bz7xiss. iczlx. , ~ . k lol)jections ~-~ ~cl rc~rltlEats fo r a h.r~arill#;rnust be i I x > > ~ - r it i r x g , a I I C 1 r 7 x u s t b c ~rece;i~rc~d b ~ , tlxe IIeari.Ix~; C;ll~rk aIx clrI~I'or~~ S el~tr:,mher 3, 2013. ~lclresses forrlxail and httnc~ deliLF~ry o i object ionsa n a l . k ~ . e a . :r i l = . r ~ ~ . . ., _ . .: > > t~ I ~ e } ) r o s= i c i c ~ c l . : iI I ~ 0CI~'R 17t3.z.,(hjIr l ackdition io fil.n~ aIx o b jection E~rhearilx~; reclu est ~t~tith tlle I-IGarirl~; Cl.c~;rk.as d}~scr:ik)ec] in ~ . t 3 C ; I ~ Z . })al-t 173, h.koasestibnxit: a crol}~- of thc~ filin~ (c>xcluclin#;sIn~- Cc rnf ' icicrri ial I3usinE~ss Inlo rrnatiarx(C,I3')} f'or ilz.c~falsictn i17 th.~ Pttl)IiCJ elock et.x7fc )rinl t ic)I7 not . tnarkecl conl ' identiaaI ) tl r su ~ l n t t c ) -1 : 0 C ~ I ~ ~ R p a r t L - r= 7 a ~ ~ ~ 1 ) etlisclose~ l)u~k)]ic:.ky l~~ L:k~:'~: E:~rit ir}lzt lzri.ornot~ic:e. SuI)2nit t_Ixe, .non-C:''~ c:~.~k~~~ clf yyi)tl_rol)ject~ic)n o l hetlr~7 reclt ltl~t, icicanttri~~cl

fungicida fenbuconazole capsicum 00399238

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