fchai. henrr y habicht iiduring the past 20 years, many studies have described the toxic effects of...

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r/- : .i/•.*;. u,. j . «i i, ENVIRONMENTAL PROTECTION AGENCY W A S H I N G T O N . D C 20460 21 1330 TMt AOMINIHTKATQH (oD 6M SUBJECT; FROM TO; Risk Assessment Forum Report on Revised Dioxin Toxicity Equivalency Factors F. Henry Habicht II Chair Risk Assessment Counci ' i Assistant Administrators Regional Administrators Introduction The attached Risk Assessment Forum report presents interim toxicity equivalency factors (TEFs) for chlorinated dibenso- dioxins and -furans (CDDs and CD/ a) for use in all Agency offices. As a 1989 update to the 1987 Risk Assessment Forum paper on TEFs, this report addresses an issue that is faced, at one time or another, by all EPA program and regional offices, by other federal agencies, and by state and national governments as well. EPA's leadership of the movement for internationally consistent TEFs, which ia described in the Forum report, requires Agency-wide consistency as well. Accordingly, the Risk Assessment Council recoanends uniform EPA use of the interim TEF values in this Forum report, unless formally exempted .by the Council . This memorandum provides background information on the basis for and use of the TEF approach and its role in risk assessment. Implications for Agency program offices and procedures for Risk Assessment Council review of possible exceptions are also discussed. Background Chlorinated dibenzo-p-dioxins and dibenzofurans (CDDs/CDFs) constitute a family of 210 structurally related chemical compounds. During the late i970s and early 1980s, EPA was faced with numerous cases of environmental pollution involving CDDs and CDFs, e.g., emissions from combustion sources, initially, concern was focused solely on 2,3,7,8-tetrachlorodibenzo-p-dioxin (2,3,7,8-TCDD) , which was produced primarily as a low level byproduct during the manufacture of certain herbicides.

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  • r/- : . i /•.*; . u,. j . «i i,E N V I R O N M E N T A L P R O T E C T I O N A G E N C Y

    W A S H I N G T O N . D C 2046021 1330

    T M t A O M I N I H T K A T Q H(oD6M

    S U B J E C T ;

    FROM

    T O ;

    Risk Ass e s smen t Forum Report on Revised Diox in T o x i c i t yEquival ency F a c t o r sF . H e n r y H a b i c h t I IChairRisk A s s e s s m e n t Counci' iA s s i s t a n t A d m i n i s t r a t o r sRegional A d m i n i s t r a t o r s

    I n t r o d u c t i o nThe a t tached Risk Asse s sment Forum report p r e s e n t s interimt o x i c i t y equivalency f a c t o r s ( T E F s ) f o r chlor inated dibenso-d i o x i n s and - f u r a n s (CDDs and CD/ a) for use in al l Agencyo f f i c e s . As a 1989 u p d a t e to the 1987 Risk Ass e s smen t Forump a p e r on TEFs, th i s report a d d r e s s e s an issue that i s f a c e d , atone time or another, by all EPA program and regional o f f i c e s , byother f e d e r a l agenc i e s , and by s ta te and na t i ona l governments asw e l l . E P A ' s l e a d e r s h i p o f t h e movement f o r i n t e r n a t i o n a l l yc on s i s t en t TEFs, which ia de s cr ibed in the Forum r e p o r t , requiresA g e n c y - w i d e cons i s t ency as w e l l . A c c o r d i n g l y , the RiskA s s e s s m e n t Counci l recoanends u n i f o r m EPA use o f the interim TEFvalues in this Forum report, unless f o r m a l l y exempted .by theCouncil .T h i s memorandum prov id e s background i n f o r m a t i o n on the basisfor and use of the TEF approach and its role in risk assessment.I m p l i c a t i o n s f o r A g e n c y program o f f i c e s a n d procedures f o r RiskA s s e s s m e n t Counci l review of p o s s i b l e e x c ep t i on s are a l sod i s cu s s ed .BackgroundC h l o r i n a t e d d i b enzo-p-d i ox in s a n d d i b e n z o f u r a n s ( C D D s / C D F s )con s t i tu t e a f a m i l y of 210 s t r u c t u r a l l y re la ted chemicalcompounds . During the la t e i970s and early 1980s, EPA was f a c e dwi th numerous cases of environmental p o l l u t i o n involving CDDs andC D F s , e.g., emiss ions f r o m combustion sources, i n i t i a l l y ,concern was f o c u s e d s o l e l y on 2 , 3 , 7 , 8 - t e t r a c h l o r o d i b e n z o - p - d i o x i n( 2 , 3 , 7 , 8 - T C D D ) , which was produced p r i m a r i l y as a low levelb y p r o d u c t d u r i n g th e m a n u f a c t u r e o f certain herb i c id e s .

  • During the past 20 years, many s tud i e s have described thetox i c e f f e c t s o f 2 , 3 , 7 , 8 - T C D D . A l t h o u g h many ques t ions remain t obe answered, d a t a show that 2 , 3 , 7 , 8 - T C D D produc e s a varie ty oftoxic e f f e c t s , i n c l u d i n g cancer and r eproduc t iv e e f f e c t s , inl a b o r a t o r y an imal s at very low doses . W h i l e some r e p o r t s sugges tthat th i s chemical produc e s s i m i l a r e f f e c t s in humans, th i squestion is s e r i ou s ly deba t ed and more d e f i n i t i v e i n f o r m a t i o n ise x p e c t e d f r o m e p i d e m i o l o g i c a l s tud i e s current ly in progre s s .For risk assessment p u r p o s e s , EPA c l a s s i f i e s 2 , 3 , 7 , 8 - T C D D a sa "B2" carcinogen with a po t ency of 1.6 x 10 ( m g / k g / - d ) M , by farthe most po t ent carcinogen yet evaluated by the A g e n c y . Thechemical is a l s o the most p o t e n t r e p r o d u c t i v e toxin yet evaluat edby the A g e n c y , wi th a R e f e r e n c e Dose (RfD) of 1 p g / k g - d .C u r r e n t l y , the A g e n c y o f t e n c o n f r o n t s s i t u a t i o n s in whichc o n c e n t r a t i o n s of some of the 209 other CDDs/CDFs . g r e a t l y exceedthat of 2 , 3 , 7 , 8 - T C D D . Example s include exposure to CDD/CDFi m p u r i t i e s in t e chnical p e n t a c h l o r o p h e n o l , CDD/CDF residues atc er ta in s u p e r f u n d s i t e s , and CDD/CDF emiss ions f r o m certaincombus t i on sources. Much less is know about the t o x i c i t y ofthe s e congener s , but a v a i l a b l e i n f o r m a t i o n shows cause forconcern for some others. For e x a m p l e , a mixture o f 1 , 2 , 3 , 6 , 7 , 8 -and 1 , 2 , 3 , 7 , 8 , 9 - h e x a c h l o r o d i b e n z o - p - d i o x i n (HxCDD) has been shownto bo carc inogenic in labora tory an imal s when admini s t e r ed at lowdose s f o r a l i f e t i m e .W h i l e da ta a v a i l a b l e f r o m long-term in vivo s tud i e s do notexist f or th e m a j o r i t y o f CDDs/CDFs, a much larger body o f da tais a v a i l a b l e on short-term jjj vivo s tud i e s and a variety of invitro s t u d i e s . T h e s e e xp er imen t s cover a wide variety of endp o i n t s e .g. , d e v e l o p m e n t a l t o x i c i t y , c e l l t r a n s f o r m a t i o n , andenzyme i n d u c t i o n (aryl hydrocarbon h y d r o x y l a s e [ A H H ] ) . . W h i l e t h edoses necessary to e l i c i t a toxic re sponse d i f f e r s in each case,the r e l a t i v e p o t e n c y of the d i f f e r e n t compounds (compared to2 , 3 , 7 , 8 - T C D D ) i s g e n e r a l l y consi s tent f r o m one e n d p o i n t toanother. T h i s general cons i s t ency o f r e la t ive p o t e n c y f or th esame compounds across several e n d p o i n t s is the empirical basisf o r t h e T o x i c i t y Equivalency F a c t o r ( T E F ) concept f o r C D D s / C D F s .A p l a u s i b l e common xnechani s ia-o f-ar t prov ide s a d d i t i o n a ls c i e n t i f i c ra t i ona l e to the approach.

    TBPThe t o x i c i t y equivalency f a c t o r method is an interimproc edure for a s s e s s ing the risks as soc iated with exposure toc o m p l e x mixtures o f CDDs and CDFs, Thf t method r e l a t e s th et o x i c i t y o f t h e 2 1 0 structure ' l y r e la t ed chemical p o l l u t a n t s t oeach o ther, u t i l i z i n g the l i m i t e d da ta bass of in vivo and invitro t o x i c i t y t e s t i n g . By r e l a t i n g the t o x i c i t y of tha 209 CDDsand CDFs to th e h i g h l y s t u d i e d 2 , 3 , 7 , 8 - t e t r a c h l o r o d i b e n z o - p -

  • - 3 '

    d i o x i n " ( 2 , 3 , 7 , 8 - T C D D ) , t h e a p p r o a c h s i m p l i f i e s t h e asses sment o fri sks i n v o l v i n g expo sure to o i x ture s of CDDs and C D F s , such asinc inera tor f l y ash, hazardou s was te s , contaminated s o i l s , a n db i o l o g i c a l media.During the l a t e 1970s and ear ly 1980s, various r e g u l a t o r yagenc i e s in the U n i t e d S t a t e s , C a n a d a , and E u r o p e , d e v e l o p e dt h e i r own TEF schemes. As a r e s u l t , numerous s l i g h t l y d i f f e r e n tTEF methods ex i s t ed vhich c o s p l i c a t e d communication amongs c i e n t i s t s and agencies in a d d r e s s i n g the t o x i c o l o g i c a ls i g n i f i c a n c e o f c o m p l e x mixtures o f CDDs and CDFs.T h e Ri sk A s s e s s m e n t F o r u m - R e p o r t sW o r k i n g f r o m p r e l i m i n a r y ana ly s e s by EPA and others c i e n t i s t s , i n 1987 E P A ' s Risk A s s e s s m e n t F o r u m issued a reporto u t l i n i n g the TEF concept and recommending use of . the m e t h o d , onan in t er im bas i s , in EPA risk as se s sments invo lv ing CDDs andC D F s . U p o n recommendation o f t h e Risk A s s e s s m e n t C o u n c i l , t h eA g e n c y f o r m a l l y a d o p t e d t h i s interim T E F procedure ( E P A - T E F / 8 7 ) ,which has been used by EPA p r o g r a m o f f i c e s and the Regions ina d d r a s s i n g a variety of s i t ua t i on s of environmental contaainat ioni n v o l v i n g CDDs a n d C D F s . T h e E P A - T E F / 8 7 m e t h o d , p u b l i s h e d a s" I n t e r i r a Procedures f o r E s t i m a t i n g Risks A s s o c i a t e d withE x p o s u r e s t o M i x t u r e s o f C h l o r i n a t e d D i b e n z o - p - d i o x i n s andD i b e n z o f u r a n s (CDDs and CDFs)," has been w i d e l y a d o p t e d and i sr e p u b l i s h e d in the a t ta ch ed r epor t . In the 1967 r e p o r t , theA g e n c y e m p h a s i z e d that the method was inter im in nature, urgedc o l l e c t i o n o f more d e f i n i t i v e e x p e r i m e n t a l d a t a , and, inp r e s e n t a t i o n b e f o r e t h e S A B , committed i t s e l f t o p e r i o d i c reviewsas a d d i t i o n a l t o x i c i t y da ta were g enera t ed .F o l l o w i n g p u b l i c a t i o n of the 1987 r e p o r t , the Agency led as i x -na t i on p r o j e c t under the au sp i c e s of NATO vhich was aimed ata d o p t i n g a common se t o f TEFs to p r o m o t e in t ernat ionalc on s i s t ency in a d d r e s s i n g contaminat ion invo lv ing CDDs and CDFs,The new Forum r e p o r t , "1989 U p d a t e to the I n t e r i m Procedures forE s t i m a t i n g Risks A s s o c i a t e d with Exposures to M i x t u r e s o fC h l o r i n a t e d Dibenzo-p-Diox in s and -Dibenzo furan s (CDDs andC D F s ) " , s i g n a l s E P A ' s a d o p t i o n o f t h e N A T O I n t e r n a t i o n a l T E F s / 8 9(I-TEFs/89) as revision to the TEFs current ly in use. The newreport pr e s en t s the ra t i ona l e , m e t h o d o l o g y , and t o x i c i t y dataused to de t ermine the new values and describes d i f f e r e n c e sbetween the 1987 and 1989 schemes.Tha I - T E F s / 8 9 represent an improvement in an a l r eady u s e f u lrisk assessment t oo l . However , tho a p p r o a c h remains interim innature and should be r ep la c ed as soon as p o s s i b l e , through theresearch o u t l i n e d in the report. S p e c i f i c a l l y , the c o m p l e t er e p l a c e m e n t of any TEF method by a f o i o a s s a y method a p p e a r s to bef e a s i b l e w i th in th e near f u t u r e i f s u f f i c i e n t research resources

  • -4-

    are d i r e c t e d at the p r o b l e m . U n t i l such research da ta aret o t a l l y d e v e l o p e d , the TEF a p p r o a c h shou ld be cont inued to berevised as new d a t a are d e v e l o p e d .i m p l i c a t i o n s f o r E P A ProgramsAs part of the Risk Asse s sment Forum examinat ion of therevised m e t h o d , EPA program and regional o f f i c e s most l i k e l y tob e i m p a c t e d ( e . g . , O S W E R , O P T S , O W , a n d Regions I I I , V , a n d I X )were asked to review and comment on any p o t e n t i a l p o l i c yi m p l i c a t i o n s f o r their programs . S p e c i f i c a l l y , these o f f i c e swere asked to a p p l y both the old and the new methods to c o l l e c t e dd a t a and to a n a l y z e the p o l i c y i m p l i c a t i o n s o f a d o p t i n g therevised scheme.It a p p e a r s that the new I-TEF/89 method is u n l i k e l y tos e r i o u s l y a l t e r assessment procedure s f o r most CDD/CDF mixture-The most s i g n i f i c a n t change in the u p d a t e d method (compared tothe e x i s t i n g EPA-TEF/87 scheme) is the as s ignment of more ' i g j -for the higher ch lor ina t ed CDDs and CDFs (hexa- h e p t a - , ana octa-s p e c i e s ) based upon s c i e n t i f i c da ta gathered in the past twoy e & r s .I n g e n e r a l , f o r many s a m p l e s ( e . g . , emi s s ions f r o mi n c i n e r a t o r s , p u l p a n d p a p e r m i l l s , b i o l o g i c a l s p e c i m e n s ) t ox i ce q u i v a l e n t s c a l c u l a t e d by the I - T E F s / 8 9 method w i l l be increasedby l e s s than a f a c t o r of two re lat ive to the e x i s t i n g EPA method.H o w e v e r , for some sources in which the h igher c h l o r i n a t e d s p e c i e sp r e d o m i n a t e ( e . g . , soil contaminated with CDDs and CDFs inp e n t a c h l o . r o p h e n o l ) , the t o x i c equ iva l en t s c a l c u l a t e d by therevi s ed scheme wi l l b e s i g n i f i c a n t l y higher. For e x a m p l e , f orsoil s a m p l e s taken around a p e n t a c h l o r o p h e n o l wood treatmentf a c i l i t y i n Region I I I a n d current ly l i s t e d o n t h e N P L ' , t h e toxicequ iva l en t s derived f r o m the I - T E F s / 8 9 are almost two orders ofm a g n i t u d e higher than those c a l c u l a t e d f r o m the E P A - T E F s / 8 7 bythe e x i s t i n g method. A l t h o u g h increases such as these may -resultin a d d i t i o n a l c l eanup requirements for some s i t e s , it is nota n t i c i p a t e d that the revised method w i l l add new s i te s to the

    N P L .C o u n c l l _ & G t l o n

    The Risk Asse s sment Council recommendation f or u n i f o r mA g e n c y - w i d e use of the TEF values in the Forum report is baaed ontwo cons iderat ions . F i r s t , f or CDDs and CDFs the TEF procedurep r o v i d e s a s p e c i f i c interim s o lu t i on for a common risk assessmentprob l em: cr i t i ca l g a p s in a data base, c oup l ed with a need tof i l l t h e g a p s with r a t i o n a l , t e c h n i c a l l y based a s s u m p t i o n s inorder to make r e g u l a t o r y dec i s ions . In th i s case, i f tha TEFmethod were not a v a i l a b l e (or if i t i s not u s e d ) , A g e n c y o f f i c e swould be f o r c e d to r e ly on random ad hoc a p p r o a c h e s or to

    c

  • -5-

    p o s t p o n e d e c i s i o n s , of course, as e m p h a s i z e d in the Forumr e p o r t / users must u n d e r s t a n d that the TEF values are based oni n c o m p l e t e da ta and that science p o l i c y c o n s i d e r a t i o n s h e l p e ds h a p e the numerical e s t imat e s . W h e n users a p p r e c i a t e theu n c e r t a i n t i e s a s s o c ia t ed with risk e s t imat e s based on TEFs, theTEFs are an a p p r o p r i a t e and u s e f u l t emporary s o l u t i o n to thep r o b l e m o f m i s s i n g d a t a f o r thi s p a r t i c u l a r c la s s o f chemicals .S e c o n d ; because o f s c i e n t i f i c uncer ta int i e s , t h e TEFm e t h o d o l o g y could wel l l ead to a j u s t i f i a b l e range of TEF valuesf or a given congener. For EPA, however, u s e o f d i f f e r e n t TEFvalues in d i f f e r e n t o f f i c e s would be an i n e x p l i c a b l e d e p a r t u r ef r o m E F A ' s l e a d e r s h i p o f t h e two-year e f f o r t t o d e v e l o pcons i s t ent in t e rna t i ona l values and me thod s for CDDs and CDFs.I n g e n e r a l , u n i f o r m A g e n c y p o l i c y a n d p r a c t i c e s f o r a s s e s s ingCDDs/CDFs .outweighs any i n d i v i d u a l p r e f e r e n c e f o r a m a r g i n a l l yd i f f e r e n t value in a p a r t i c u l a r EPA o f f i c e .The Counci l recognizes that new d a t a or spec ialc ircumstance s may j u s t i f y e x c e p t i o n s or new revisions to the I-T E F s / 8 9 . A n y A s s i s t a n t o r Regional A d m i n i s t r a t o r m a y a p p l y f o re x e m p t i o n f r o m thi s agency-wide requirement through a memorandumto the Chairman of the Risk A s s e s s m e n t Council e x p l a i n i n g (1) th»p r o p o s e d change in an I-TEF/89 value f o r any congener, (2) t h es c i e n t i f i c d a t a or r a t i o n a l e u n d e r l y i n g th e request , and (3) anyr e l a t e d program management c o n s i d e r a t i o n s .

    A t t a c h m e n tc c : W i l l i a m K . R e i l l yRisk A s s e s s m e n t Counci lRisk Ass e s smen t Forua

  • Federal Ratater / Vol M. No. 214 / T u e s d a y . N o v e m b e r 7. 1983 / Nobce i 487E7Ctt!fOUCorpontJon/Dov*'t Gulf$*fic*. tt a/. S/Jl/ttal

    The DOE t i i m d i D«cUioQ and Orderconcerning » A p p l j c a t t O f l J f o r Refundsubmi t t ed in t h a . G u l f Oil Corporat ion*pect*l refund proceeding. Eacha p p l i c a : . o n was a p p r o v e d u*ing ap r e i a m p u o n of i n j u r y . The *um of ther e f u n d ! grimed in ihn D ecu ion.Including (nlere*t Ii &J.938.Gul/Qi! Corpora lion/Luna ford Oil Co..Inc. et oL 9/1/69, RFW&-$3? tt ol.The DOE is sued a D e c i i i o o tnd Orderc once mm* f i v e A p p l i c a t i o n * for Refunds ubmi t t ed ID the Cul/ Oil C o r p o r a t i o nsp e c ia l refund proceeding ThiA p p l i c a t i o n s were a p p r o v e d u i lng ip r e s u m p t i o n of injury. The sum of therefund* granted tn (Jus Decision. whichincludes both principal ind intere s t iiW.4M.C

  • FsriarW RaTcbter / VoL 54, No. 214 / Tu**day. November 7. 19» / Notice*cm b* obtained only from tb*Ctnonnatt o f f i c e .CO* PUWTHtW t t f O M M - n C M 6OB e l l e Cantor, Technical LUiwn, RiskAB4«*ime&t Forua, (202] 47£-6?43.

    fa ;heg o f 1987. EPA'i Risk Auft s s iu .-ntFono* p u b l i s h e d • report e n t i t l e d"Interim Procedure s f or E s l i n u f i r ? Risk*Associated wuh Expo sur e s to M i x t u r e sof C h ' ^ r n a f e d Dibenzo-p*niox!ni and *Dibenzofuram ( C D D s / C D F * ) . " ' T T i i ireport out l ined the toxic i ly equivalency' r ; : l c - ( T E T J method a?.d recommended(Lat EM use thi s method, OB in interimKMIS. in rick assessments Involvingmixtures o / C D D i ind CDFv Uporraccn:.widailon o f E T A ' i RiskAisessmer.; Council. the Agencyf - . r m a ' l y a d o p t e d thi i interim T E FprceeJure It !u,i bê n uied by EPA toaddress* v t r ' d y o f environment«lconfa o.:nt ton i o c i d f c t i invoKutR CDDcand CJF*.The TET method is *a in '.e runprocedure "or asses s ing ihe risksM s i t M i e d win •xpovu/ t t (o complexmixiures u f C D O s and C D F s . CDDs andCDFj con fu t e « f a m i l y of 210s i r u e l u / a l f y - r c l a i c d chfir.icalcompound*. I n c l u d i n g ^7*ft-i e l ro chIoTod:beruo-p-i* TSFprocedure allows tn/onuaUoo on aknown chemical to b* uitd In MMuiugre la led cheuiicaU wb«re IitUe or no dataexi iL Thja. la turn. p«rmit» thtrtweumect o/ both urctru>g«nk andnonurcino^ciuc nxlca involvinge x p o t u / e i t o m J x t u r t « o f COOtaiutcor*.In IU 1M7 report tb« Agencyeraphaiized lhat the m«thod wu interim•n rwi-irc. urged collecOoo of mdrcd r t f u i i i t v * exp«rimenul daU, Andr remitted i'ic!f to periodic review} ait-M riiy dtU were s o n T a i t d -th e p j s : d e o i d t f . van«,uc* .:es m !he Ud«.r

    •:v- 1 TCK fc-hc.rcs Ai a rats!!.i- i iT.c; •«» *ligh'.:y J-/."- .̂ ni TTPm i s l e d . AJ a ru»u!l nui.*.er*>ad ;>l>«!nf . .enl T C r ' m c L i o d i e s i a i rd . T N . is- ..-r.'.iii i.-.d nancies -n j J J / « ^ : r t | th*l o x j c u I c g . ' C ' i l s i g n i f i c a n c emix ' . j r e i o f t^OUa and COFf.

    To addreM this inu*. the A g e n c y I*da lix-nation pro|«a ondcr thf «wp4c**of NATO which wu atmed at i dop t iaga common, (nternadono) i«t oi TEf t fora i M r t t n j j riikj of cor.la.ninatioainvolving CDDs and C U F v Th« Forumreport iuued (ocWy, "Inler-m Procedu(«sf c r E s ' t r a d U n g Ri»ki A i S ' . c t a t e d withExpiiuns to Mixture s c,f Chlonn^tcdOibenzo-p-Oioxi^i mi •DibcruofWam( C D D i and CDFs) and 19U3 Upd*t«. ' isbaieu on that elrox L Mos t in:pori«Q;ly.EPA ha< a d o p t e d th e NATOI n t e m a l i o n a l T L P i / 8 8 ( I - T E F » / do f which d i f f e r fron U i £ C P A - T S - ' i / a ?c u r r e n t l y in use. L£* me origin*!ictteou. J-TEF* art ba»«d on. avaiUhks d e n t i / l e data and recognition o/ tbcvalue of international cons i s t ency lo tbaf i e l d . The Fomm report pre sent! ther a l i o n a l e . me thodo l ogy , and toxicityd a t a used to d e t r r m f n e c e r f a i r . new TEFvalue! and describes d i f f e r » n c « tbetween the 1967 and 1&9 f i g u r e s , tegeneral the e f f e c t of the m o d i f t c s t f o n i ial i k e l y (o be modert for tro*t eoicpl^xmixture*Tlw I-TEFs/89 repf«enl enimprovement in an already ueful riskassessment tool. However, the approachremain* Interim fa lutur* and should b«rcpUced with relevant experiaentaldart M tuch date became tviikbfc.Promiiing p r o p e f i fi bmug oiaek hi thisDatvd

    Acting AsHittaiti AdminktiQtor for Remrchand Development.|FR Doc ao-2tto3 FiW ii-e-edc «.tl am)coot sa it

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    of Usw^aawol ind budge} far Kevfet*Oclot-r A3. 1 We.C o m m i j j i o n has tubotit ted. t iainform a l ion co l l e c t i on requirement* to0MB fo/ review and clearance unJceIhp P a p e r w o r k Kcduclf&n Ac*, of 1̂ 00 (44o.s.a uon-u f i f t c i * liib.*rJ L id fr^ni Ir.a C c m m h f i c n ' s w j p yr . Int ern i i ionai T r u n s c f ' p t ' u nSer'.;..S- (2»2! flr-3TOO. 2100 M S t f « IMV- Su;'« 140. Wj*hi.ve.i. WT 2003?.in fonr i i i^n on IMS*cor.Uci J - j J y Bo!f>y. F-der t l?S!3- P:rtcns iv ; t fr.;na to c crr/nenl onthe s e lO/ora tabon coQacdoascontact E y t e t t e F l y n n , O f f i c e o f

    Management end Bed̂ e*. KoomNEOa W a i h h i f K m . DC 20603. ( 7̂51 393-3785.OMB Ntwt&r 3060-Q2W.Title: Ser. i ion eOMfb)— T h y i i c a l l yf f e m t ' u p p s d " S p e c i a l E J i f i i b i l i t yAcftun; Extens ion.: I n d i v i d L - u l s or household vesponse: On occasion.A.IIIUC/ Burden: 20Hoar*.

    S: Section 90.S8fb)pravJdea Hui penant claiauJageligibib'ty in the Special EmergeacyRadio Senrice on ih* tmtis of baiccp h y i i c a U y handicapped oiiut prescvt• phyiidf l f l ' s Etatement bidicatt^ that(bey are handicapped, Submiasida ofthJ« tn f onna t j on it neeeAaary toeosora that frequencieA itsened forl i c ens in f t to hand i capped individwbare not licensed to aoc fhandicappcdpencils. The ConmlsiJon tuet tktin format ion to di lcrmiot tba•ligibi t i ty of app l i caaU for licemea ong p K d ' f i cOMB Nuaibefi 306(MJaa.Title; Sectioo 90-U9(b)— S o p p l e a e o d lf n f o r a i t l o n lo be RoulineJy Sobn f t t cdwith A p p l i c a t i c r j (Non type-*ccept«dequipment}.Respondent* S t a t e or fecalj o v c r o n w o ' i . n o o - p J M / i t butitntkuu,end business* i (induding p*»Ubustnesse*)Frequency ofResponte: Oa occjsioa.Estimated AJWUQ! Burden: 100Responies: 34 Hour*,A'ee^j am/ /Aes.- PrecUcally «U t e J l aIr a DJ mill ing e q u i p j o f n t used In thaicountry i* manufactured to ccrUintechnical *4>ecirtcation* which. (OAbUft (o be designated u "typc-accept«d"by FCC laboratey ptnoantL Socb a.deaignitieui shows the purcbaur thatIhe equipment U capable olper fonniag within certain loleraaccathat Umit the teterfcrtoc* potenu*! ofthe device. For the few applicant*propoaing lo us« truumittaiitquiproent not proven lo meet lh«*Sspec l t i caUoRc, a t f e s c r f p t l u n of thepropctcd e q u t p m f i t i t U rtquircd. Thainformation col l ided is used by FCCengineer* to determine th*i r . ' c r f e r u r . c e po t en t ia l of the poperation.

    Tit.'*: Sec t ion 00.138! J * tj—M o d i f i c a t i o n o f L l a T . s e ,Action. Exte.nton.^ f«W0.*fe St4Vj tovenunertu. Ron- p r o f i t i n t - t f .:sr. ̂ 1

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    111. U p d a t e of E P A - T E F s / 8 7 :A d o p t i n g the 5-TER89 SchemeA. S i m i l a r i t i e s Between l - T E F s / 8 9 and E P A - T E F s / 8 ?T a b l e 3 d i s p l a y s the 1 - T E F & 8 9 and she E P A - T E F s / 8 7 .The two sets of TEFs have several concepts m common. T h e y share Jheconceptual Iramework of the TEF approach. T h a i i s , the s tructure-act ivi tyr e l a t i o n s h i p is assumed to be s u f l i c i e n t l y strong that estimates of the 'long-term t o x i c i t y ol m i n i m a l l y te s ted congeners o* COOa'CDFs can b©reasonably in f err ed on the basis of available

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