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# OAR Box 

# 1827 Prepped byCharmelle Mathews



### Document

Number: 

# 130 ) 

# 1- 1 Docket Number: 

# A-90-0 7

Printed 11/19/200812:40:48PM Sheet 130of 147

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## Ar-90-o- 7 X- 1

ENVIRONMENTAL PROTECTIONAGENC Y

4 0 CFRPar t 7 9 

## WG- 9 EP A AI RD Fuel s an

d Fue l Additive s Registratio nRegulation s

AGENCY : Environmenta l Protectio n Agenc y(EPA) . ACTION : Advanc e Notic e o f Propose d Rulemaking (ANPRM) . SUMMARY : Thi s actio n announce s EPA' s inten t t o develop regulation s an

d establis hprogra mprotocol s an

d tes t procedure s relate d t o th e testing o f moto r vehicl e fuel s an d fue l additive s fo r purpose s o f registratio n a s prescribe d in §211(b ) an d (e ) o f th e Clea n Ai r Act . Th e regulation s ar e t o provid e fo r test s t o determin e potentia l publi c healt heffect s an d such othe r informatio n a s i s reasonabl e an d necessaryt o determin e emissio n contro l systemeffect s an d welfar e impacts . Th e regulation s wil l appl yt o curren t an d futur e fuel s an d fue l additive s require d t o b e registere d unde r §211 . Bylaw , the regulation s mayals o incorporat e smal l busines s an d cos t sharing provision s an d provision s t o guard agains t duplicativ e testing .P. 3

DATES : EPAwil l conduc t a hearing o nthi s Advanc e Notic e o f Propose d Rulemaking (ANPRM ) o n Septembe r 26 , 199 0 i nAnn Arbor , Michigan . Th e hearing wil l conven e a t 9:0 0 a.m . an d wil l adjourn a t suc htime a s i s necessaryt o complet e th e testimony . Writte n comment s o nthi s ANPRMwil l b e accepte d fo r 3 0 day s following th e hearing . ADDRESSES : Th e hearing wil l b e hel d a t Domino' s Farm s i n Ann Arbor , Michiga n (313-930-5032) . Domino' s Farm s i s locate d o n Earhar t Roa d jus t on e quarte r mil e eas t o f Plymout hRoa d a t US-23 . Comment s o n th e ANPRMshoul d b e submitte d i nduplicat e to : EPAAi r Docke t (LE-131) ; Attention : Docke t No . A-90-07 ; U.S . Environmenta l Protectio n Agency , RoomM-1500 , 40 1 MStree t SW , Washington , D C 20460 , (202 ) 382-7548 . Thi s docke t i s locate d a t th e abov e addres s o n th e firs t floo r o f Watersid e Mal l an d i s ope nfo r publi c inspectio n weekday s fro

m8:3 0 a.m . t o 12:0 0 noo n an d fro m1:3 0 p.m . t o 3:3 0 p.m . A s provide d i n 4 0 CF RPar t 2 , a reasonabl e fe e mayb e charge d byEPAfo r copying services . FORFURTHE RINFORMATIONCONTACT : Mrs . Caroly nKrueger , Emissio n Contro l TechnologyDivision , U.S . Environmenta l Protectio n Agency , 256 5 Plymout hRoad , AnnArbor , M I 48105 , (313 ) 668-4274 . 

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SUPPLEMENTARYINFORMATION :

I . Publi c Hearing

An yperso n intereste d i n presenting testimon ya t th e publi c hearing shoul d notif yth e contac t perso nliste d abov e o f suc hinten t a t leas t seve n day s prio r t o th e day o f th e hearing . Th e contac t perso n shoul d als o b e provide d an estimat e o f th e time require d fo r th e presentatio n o f th e testimon

yan d notificatio n o f an ynee d fo r audio/visua l equipment . Asign-u p shee t wil l b e availabl e a t th e registratio n tabl e th e morning o f th e hearing fo r scheduling th e orde r o f testimony . 1 ^ i s suggeste d tha t sufficient : copie s o f th e statemen t o r materia l t o b e presente d b e brough t t o th e hearing fo r distributio nt o th e audience . ,

Mr . Richar d D . Wilson , Director , Offic e o f Mobil e Sources , Offic e o f Ai r an d Radiation , ha s bee n designate d a s th e presiding office r o f th e hearing . Th e hearing wil l b e conducte d informally , an d technica l rule s o f evidenc e wil l no t apply . Writte n transcript s o f th e hearing wil l b e made . Anyon e desiring t o purchas e a copyo f th e transcrip t shoul d mak e individua l arrangement s wit hth e cour t reporte r recording th e proceedings .



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II . Introductio n

EPAi s announcing it s plan s t o implemen t it s statutory authorit yt o asses s th e effect s o f moto r vehicl e fuel s an d fue l additive s o n th e publi c health , welfare , an d emissio n contro l systems . Th e progra mbeing develope d i s expecte d t o b e an importan t mean s o f gathering informatio nabou t the healt han

d welfar e effect s o f fuel s an d fue l additives . Base d o n th e tes t dat a an d othe r informatio nobtained , EPA wil l b e abl e t o evaluat e whethe r an ylimit s ar e neede d o n fuel s an

d additive s unde r th e statutorycriteri a i n§211(c) .
EPAha s recentl ystarte d th e developmen t o f th e propose d rule s an

d welcome s publi c inpu t regarding th e bes t wayt o structur e th e programt o achiev e th e Congressiona l goals . EP Ai s intereste d i nway s t o mak e th e progra m manageable , minimiz e undu e burdens , an d a t th e same time ensur e tha t a n adequat e leve l o f testing i s done . Thi s ANPRMwil l discus s issue s an d option s involve d i n determining potentia l publi c health , welfare , an d emissio n contro l systemeffect s o f fuel s an d fue l additives .



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Thi s Advanc e Notic e i s organize d t o highligh t topi c area s an

d issue s tha t ar e importan t fo r progra m development . I n some cases , EPAha s identifie d it s tentativ e plan s a s a basi s fo r inviting comment . I n othe r areas , wher e th e preliminaryplan s ar e les s developed , th e notic e raise s question s an d solicit s informatio n from commenters . EPAha s identifie d a numbe r o f topic s an d question s i n thi s notic e upo n whic hi t particularl yseek s comments . Comment s an d suggestion s fro mth e public , th e affecte d industry , environmenta l interests , an d th e scientifi c communit yar e especiall ysought . Th e remainde r o f thi s notic e is , divide d int o th e following genera l areas . Following thi s introductory section , a summaryo f th e statutoryauthorit yi nthi s are a i s give n togethe r wit ha chronologyo f pas t action s an d recen t developments . Thi s i s followe d b ya fairl ybroad discussio n o f th e designan d implementatio nissue s relate d t o th e fue l an

d fue l additiv e testing program . Base d o n thi s discussio n an

d analysis , th e nex t sectio n describe s i n genera l term s a possibl e programapproac hfo r health , emissio n contro l system , an d welfar e testing an d assessments . Th e ANPRMclose s wit ha n invitatio nfo r publi c participatio n an d a detaile d lis t o f question s an d issue s o n whic hEPAdesire s comment .



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III . StatutoryBackground an d Provision s Sectio n 211(a ) o f th e Clea nAi r Ac t (CAA) , 4 2 U.S.C . §7545 , give s th e Administrato r th e authorit yt o requir e th e registratio n o f fuel s an d fue l additive s prio r t o sal e or introductio n int o commerce . EPAissue d suchregulation s i n 197 5 (4 0 CFRPar t 79) .
I n 1970 , EPAwa s give nauthorit y(PL 91-604 , Decembe r 31 , 1970 ) t o requir e certai ntest s an d othe r informatio n befor e registratio n o f fuel s an d additives . Mor e specifically , §211(b)(2 ) provide d tha t EPA"ma yals o require " th e manufacture r "t o conduc t .test s t o determin e potentia l healt heffects " (including carcinogenicity , teratogenicity , an d mutagenicity ) o f fuel s an d fue l additive s an

d t o requir e othe r "reasonabl e an d necessary " informatio n t o identif yemission s an d thei r effect(s ) o n th e emissio n contro l systemperformanc e o f vehicle s o r vehicl e engine s an d th e publi c healt ho r welfare . Test s fo r healt heffect s ar e t o b e conducte d according t o procedure s an

d protocol s establishe d b yth e Administrato r an d an yresult s wil l no t b e considere d confidential . Also , §211(b)(3 ) state s tha t th e Administrato r shal l gran t registratio n i f th e abov e provision s ar e satisfie d including assurance s tha t th e Agenc ywil l receiv e an y futur e change s i n th e informatio nrequired . 

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Althoughth e genera l registratio n regulation s wer e implemente d i n 1975 , EPAdi d no t implemen t th e discretionaryauthorit yt o requir e health , welfare , an d emissio n contro l systemeffect s testing unde r §211(b)(2 ) o r establis hprocedure s an d protocol s fo r thes e tests . I nth e CA AAmendment s o f 1977 , Congres s added a requiremen t t o §21 1 (PL 95-95 , Augus t 7 , 1977) . Thi s requirement , codifie d a t §211(e) , mandate s tha t th e Administrato r implemen t th e §211(b)(2 ) authorit yan d provide s additiona l directio n concerning th e implementatio n o f th e §211(b)(2 ) testing requirements . Sectio n 211(e)(1 ) require s implementatio n o f th e §2ll(b)(2 ) authorit ywithi non e yea r o f enactmen t o f th e amendments . Sectio n 211(e)(2 ) als o establishe s time limit s b ywhic hproducer s mus t compl ywit hth e regulations . Fo r thos e fuel s an

d additive s no t registere d a t th e time th e §21l(b)(2 ) , regulation s ar e promulgated , th e "requisit e information " mus t b e submitte d prio r t o registration . Fo r fuel s an

d additive s registere d a t th e time o f promulgatio n th e informatio n mus t b e provide d "no late r tha n thre e years " afte r promulgatio n o f th e §211(b)(2 ) regulations . Sectio n 211(e)(3 ) allow s th e Administrato r t o exemp t o r mak e specia l exception s fo r an ysmal l business , t o provid e fo r cos t and/o r burde nsharing wit hrespec t t o an yfue l o r additiv e manufacture d b ytw o o r mor e entities , an d t o exemp t an

yperso n fromsuc hregulation s wher e additiona l testing woul d b e duplicativ e o f adequat e existing testing . -7

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I n a n effor t t o fulfil l th e §211(e)(l ) requiremen t tha t regulation s b e promulgate d withi n on e year , EPA publishe d an ANPRMi n 197 8 (se e 4 3 FR38607 , Augus t 29 , 1978 ; Docke t ORD-78-01) ; however , neithe r a propose d no r fina l rul e wa s issued . Nevertheless , i t ha s alway s bee n EPA' s intentio n t o develop th e require d regulations . Thi s actio n ha s remaine d o n th e EPAregulatoryagenda an d a developmen t pla n fo r th e rulemaking wa s create d i n1988 .
Eve n thoughth e §211(b ) testing requirement s wer e no t implemente d whe n required , ther e hav e bee n othe r effort s relate d t o fuel s an d additive s ove r th e pas t te nyears . Th e fue l an

d fue l additive s registratio n programi s currentl yoperative . Sectio n211(f ) an d th e EPA interpretive rul e o n "substantiall ysimilar " fuel s (4 6 F R 38582-38586 ; Jul y28 , 1981 ) hav e serve d t o contro l th e

i marke t entryplac e o f fuel s an d direc t additive s absen t a waive r unde r §211(f)(4) . Also , EPA' s Draf t Alternativ e Fuel s Researc hStrateg yprovide s broa d directio n concerning th e researc hneede d t o asses s th e potentia l relativ e publi c

i healt han

d welfar e risk s o f variou s fue l formation s i n production , transport , storage , an d vehicl e use . Acopyo f thi s "Draf t Strategy " i s availabl e i n th e publi c docket ; inquirie s shoul d b e directe d t o EPA' s Offic e o f Researc h an d Development . I n addition , th e literatur e reflect s th e result s o f a numbe r o f program s conducte d t o evaluat e 

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advers e effect s o f fuel s an d additives . Alis t o f man yo f th e report s publishe d i n thi s are a canb e foun d i nDocke t No . A-90-07 . Thus , whil e th e require d §21 1 progra m wil l provid e valuabl e additiona l informatio nfo r assessing risk , ther e hav e alread ybee n some activitie s tha t relat e t o fuel s an

d additives . Some recen t development s hav e renewe d EPA' s commitmen t t o issu e th e regulation s a s calle d fo r b yth e statute . First , a Jul y19 , 198 9 citizen s petitio n unde r §2 1 o f th e Toxi c Substance s Contro l Ac t (TSCA) , 1 5 US C §2620 , requeste d th e Agenc yt o initiat e a rulemaking unde r § 4 o f TSCAt o requir e testing o f methano l fuel s b ythei r manufacturer s and/o r processors . AnOctobe r 17 , 198 9 lette r from

EPAAssistan t Administrato r Lind a J . Fishe r announce d tha t EPAwoul d initiat e a proceeding unde r th e join t authorit yo f §21 1 o f th e CA Aan d § 4 o f TSCAt o conside r healt han d environmenta l effect s testing o f al l moto r vehicl e fuel s including fuel s currentl yi n us e an d thos e undergoing development . Second , a citizen s grou p brough t a lawsui t challenging EPA' s failur e t o promulgat e regulation s withi nth e one-yea r perio d provide d fo r i n CA A§2ll(e) . Thoma s v . Reilly , CA . No . 89-626 9 (D . Oreg . 1989) . EPAha s entere d int o a Consen t Decre e i n settlemen t o f thi s lawsuit , withou t th e 

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-P.1 1 adjudicatio n o f an yissue o f fac t o r law , an d the Decre e ha s bee n signe d byth e Court . Unde r th e Decree , th e EPA Administrato r i s t o signa Notic e o f Propose d Rulemaking fo r publicatio n i n th e Federa l Registe r b yJanuaryl , 1992 , an d t o sign a Fina l Rul e b yJun e l , 1993 . B yit s terms , th e Consen t Decre e "i s no t addresse d t o th e substanc e o f th e rulemaking " an d nothing i n i t i s t o b e construe d "t o limi t o r modif yth e discretio naccorded...b ySectio n 211...o r genera l principle s o f administrativ e la wi n an

y fashion" .
IV . Fue l an

d Fue l Additiv e Progra m Designan

d Implementatio n Issue s

• A . Introductio n Th e CA Arequirement s clearl yindicat e tha t th e fue l an d fue l additiv e programprovide d fo r i n§21 1 i s potentiall yvas t i n scop e an

d raise s difficul t implementatio nissues . Thi s notic e present s th e factor s tha t wil l influenc e progra m design an d discusse s ho wth e requirement s o f th e Ac t ca n bes t b e implemente d i n ligh t o f statutoryan d practica l constraints .

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Th e statutoryprovision s governing th e fue l an d fue l additiv e progra

m wer e discusse d above . I n summary , §211(b)(2)(A ) require s testing t o determin e potentia l publi c healt heffect s o f th e fuel s an d fue l additive s themselves . I n addition , §211(b)(2)(B ) provide s authorit y fo r obtaining reasonabl e an d necessaryinformatio nrelate d t o th e emission s resulting fro ma fue l o r fue l additive , an d th e effec t o f suc hemission s o n th e performanc e o f th e emissio n contro l system , an d an assessmen t o f th e effec t o f suc hemission s o n th e publi c healt han d welfare . Furthermore , §211(e)(2 ) require s th e "requisit e information " fo r registratio n t o b e supplie d t o EPAwithi n certai n time limit s an d §211(e)(3 ) jnclude s provision s whic hclearl yindicat e tha t cost^sharing i s t o b e take n int o consideratio n i ndeveloping sucha program . Th e legislativ e historyals o indicate s tha t cost s shoul d b e considere d i n promulgating tes t requirement s an d tha t th e regulation s ar e no t t o b e "undul yburdensome" . H.R . Rept . No . 95-294 , 95t hCong . 1s t Sess . 308-0 9 (1977) .

A t th e same time , ther e ar e a numbe r o f practica l factor s whic haffec t ho wthes e requirement s ca n b e implemented . First , ther e ar e ove r 600 0 active-registere d fuel s an

d fue l additive s whic hcoul d potentiall yb e subjec t t o health , effect s test s an d th e othe r requirement s discusse d above . Thi s i s mor e tha ntwic e th e numbe r
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registere d whe n th e §211(e)(l ) requiremen t wa s establishe d and , a s discusse d below , thes e ar e expecte d t o gro wi n numbe r th e future . T o requir e al l o f th e approximatel y 600 0 fuel s an

d additive s t o underg o extensiv e individua l testing concurrentl ywoul d plac e onerou s administrativ e burden s o n th e program , woul d als o b e very resource-intensiv e an d coul d easil yexcee d the capacit yt o conduc t suc htests . Moreover , testing o f eac hfue l an d additiv e i s no t neede d i f theypresen t essentiall yth e same risk s o f publi c healt han d welfar e an

d emissio n contro l impacts . Second , fuels/additive s consis t o f variabl e comple x mixtures . Dealing wit hmixture s an d thei r emission s presen t difficultie s i n determining wha t t o tes t (i.e. , whol e mixtures , fractionate d components , transformatio n products , etc. ) an d ho wt o tes t it . Whil e some detaile d tes t procedure s d o exis t fo r some exposur e routes , healt h effec t en

d points , etc. , some , a s fo r atmospheri c transformatio n products , mayb e undeveloped . Th e stat e o f knowledg e regarding tes t procedure s wil l significantl y influenc e th e abilit yo f EPAt o prescrib e th e appropriat e testing procedures . Furthermore , test s suc ha s long term cance r bioassay s ordinaril yrequir e mor e time tha nth e three-yea r perio d specifie d fo r submissio no f requisit e informatio n fo r fuel s an d additive s registere d a t th e time -12

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th e rul e i s promulgated . I nsome cases , especiall yi n chroni c testing , i t mayno t b e possibl e t o obtai naccurat e an d conclusive result s withi nth e prescribe d time specifie d b yth e Act . Third / health , welfare , an d emissio ncontro l system impac t testing i s costl yt o administe r an d conduc t o na case-by-cas e basi s and , give nth e potentia l numbe r o f fuel s an d additive s an

d type s o f test s whic hmaynee d t o b e conducted , th e overal l cost s o f an exhaustiv e programwoul d b e burdensome . Fourth , complicating thi s furthe r ,i s th e fac t tha t a t presen t ther e ar e onl ya relativel ylimite d numbe r o f tes t laboratorie s capabl e o f conducting suc htesting an d othe r evaluations , an

d fue l an

d fue l additive s wor k woul d no t b e th e onl y; typ e o f testing being handle d a t thes e facilities ; I n addition , testing fo r atmospheri c transformatio n product s an d thei r impac t o n ai r qualit yan d healt heffect s maypresen t a neve n greate r difficult yi n thi s area .

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Th e statutoryrequirement s an d practica l constraint s presen t wha t mayappea r t o b e a conflic t betwee nth e goal s an d th e mean s o f achieving them . Th e statut e call s fo r health , welfare , an d emissio n systemimpac t testing t o b e don e an

d provide s a specifie d time frame fo r submitting informatio n wit hdu e consideratio nt o b e give n t o cos t an d undu e burdens . Areviewo f th e practica l factor s suggest s tha t thi s coul d b e difficul t sinc e th e fue l an d fue l additiv e populatio n i s large , test s ar e time consuming , costl yan

d sometime s inconclusive , an d laboratorie s an d othe r facilitie s capabl e o f doing th e testing ar e limite d i n number . * Th e statutorymandat e an d it s legislativ e history provid e fo r some measure s tha t hel p alleviat e th e burden . A s discusse d above , th e statut e contain s provision s fo r cost-sharing an

d non-duplicativ e testing , a s wel l a s a smal l busines s exemption . Pursuan t t o th e applicabl e legislativ e history , cost s an d th e preventio n o f undu e burden s ar e t o b e take nint o accoun t i n developing th e tes t requirements . Moreover , "relativel yinexpensiv e bu t reliabl e tes t methods " ar e t o b e use d "insofa r a s possible. " H.R . Rept . 95-294 , 95t hCong . 1s t Sess . 30 9 (1977) . Th e statut e als o relie s o nEPA' s judgmen t i n establishing th e tes t program . Wit hrespec t t o th e timing o f dat a submission , EP Aha s discusse d belo wa numbe r o f option s whic hcoul d provid e additiona l tim e fo r testing whe n mor e time i s needed . -14

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I n exercising it s regulatoryjudgment , i t is . EPA' s inten t t o develop a workable , usefu l progra m whic h satisfie s th e goal s o f th e Act , allow s fo r th e adequat e assessmen t o f potentia l health , welfare , an d emissio n contro l systemperformanc e impact s a s required , bu t doe s no t introduc e an infeasibl e or needles s testing burde no n th e producer s o f th e fuel s an d additives . Determining representativ e fuel s an d additive s t o test , th e test s t o whic htheyshoul d b e subjected , an d th e criteri a t o b e use d fo r suc hdetermination , wil l b e animportan t par t o f thi s rulemaking . Th e progra mdesignneed s t o focu s o nth e potentia l effectivenes s o f a give n regulatoryrequiremen t i n meeting th e goal s o f th e Ac t an d whethe r th e result s o f suc hrequirement s wil l provid e usefu l informatio n fo r decisio n making . Th e fue l an

d fue l additiv e testing program wil l represen t a Congressionally-mandate d ris k assessmen t fo r potentia l advers e effect s o nhuma n health , welfare , an d emissio n contro l systemperformance . Sinc e ris k i s a functio n o f exposur e an d toxicit y(or effect) , on e ke y tene t o f th e programwil l b e t o asses s potentia l ris k using thes e factors . Consideratio nwil l b e give n t o productio n volum e an

d known toxicologica l o r othe r propertie s i n determining th e amoun t o f testing needed . Furthermore , i t

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wil l b e importan t t o mak e appropriat e us e o f th e §211(e)(3 ) provision s t o reduc e cost s an d eliminat e replicat e or unnecessarytesting . Previou s testing , th e know n similarit yo f man

yfuel s an

d additives , an

d th e curren t stat e o f knowledg e o f th e risk s associate d wit hpresen t fuel s an

d additive s mus t b e take nint o account . Th e remainde r o f thi s sectio n o f th e notic e discusse s some o f th e keyprogra m designan

d implementatio nissue s i n mor e detail . Thi s include s mor e detaile d discussions , analyses , an

d request s fo r commen t o n bot hth e statutory requirement s an

d th e practica l design factor s mentione d above . *

B . Designatio n o f Fuel s an d Fue l Additive s Unde r th e curren t fue l an d fue l additiv e registratio n regulations , moto r vehicl e gasolines , diese l fuel s an d thei r additive s ar e th e onl ydesignate d fuel s an d additive s fo r purpose s o f registratio n(Se e 4 0 CF RPar t 79) . Ther e ar e currentl yapproximatel y224 0 active-registere d fuel s an d 379 0 active-registere d fue l additive s whic hmean s that , depending o n programdesign , a significan t amoun t o f testing coul d b e required . Recen t development s i nth e are a o f alternativ e fuel s sugges t tha t suc hfuel s an d thei r additive s shoul d als o b e covere d b yth e regulation s -16

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covering gasolin e an d diese l fuels . Give nth e potentia l fo r a majo r expansio n o f thes e fuel s int o th e marketplac e i n th e future , EPAi s no wconsidering issuanc e o f a proposa l whic hwoul d designat e severa l additiona l moto r vehicl e fuel s an

d thei r additive s fo r registration . (5 5 F R16876 , Apri l 23 , 1990 ) Thi s coul d include : methanol , ethanol , o r an

yothe r moto r vehicl e alcoho l fuel[l] , liquefie d petroleu

mgas , an

d compresse d natura l gas . Thes e change s woul d expan d th e type s o f fuel s an d additive s requiring registration . Give n th e larg e numbe r o f individua l fuel s an d additive s involved , EPAi s considering .measure s t o reduc e th e cost/testing burde n whil e a t th e same time stil l meeting th e requirement s o f th e programa s calle d fo r i n th e Act . Authorit yfo r thes e provision s i s found i n §211(e)(3 ) o f th e Act . Sectio n211(e)(3)(A ) provide s fo r specia l requirement s fo r smal l business .
[1 ] Alcoho l fue l woul d likel yb e define d a s a moto r vehicl e fue l containing a t leas t 5 0 percen t alcoho l b y volume . Mixture s o f alcohol s an d gasoline s woul d likel yb e registere d a s a gasolin e i f th e alcoho l conten t wa s les s tha n5 0 percent .

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Sectio n 211(e)(3)(B ) provide s fo r cost/burde nsharing fo r a fuel/additiv e produce d b ymor e thanon e person . Finally , §211(e)(3)(C ) remove s th e nee d fo r additiona l testing whe n previou s testing i s adequat e t o mee t th e requirements . Discussion s an d some possibl e concept s i n eac ho f thes e thre e area s i s provide d below .
I n addition , EPArecognize s th e importanc e o f avoiding tes t requirement s whic hlead t o th e unnecessaryus e o f animals . Eac ho f th e concept s belo wwoul d contribut e t o thi s objective . Furthermore , late r i n thi s notic e th e Agenc yrequest s commen t o nothe r approaohes , suc ha s tiere d requirements , th e us e o f non-anima l tes t system s wher e appropriate , an

d th e us e o f structure/activit yan d physica l chemica l dat a whic hwoul d als o limi t testing requirement s an d unnecessaryanima l use . C . Provision s t o Preven t Undu e Burden s 1 . Smal l Busines s Provision s

I n orde r t o preven t th e testing requirement s from bein g undul yburdensome , th e CA Agive s th e Administrato r authorit yt o exemp t o r provid e deferral s o r modification s fo r smal l businesses ; however , "smal l business " mus t b e define d i n th e regulations . EPAi s considering a definitio n including sales/revenu e alon e o r i ncombinatio n wit ha n annua l productio nvolum e fo r a give nfuel/additiv e -18

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a s par t o f thi s definition . I naddition , th e toxicit yor potentia l ris k o f th e fue l o r fue l additiv e mayb e take n int o consideration . Whil e sales/revenu e mayb e mor e appropriat e t o ge t a t th e abilit yt o payaspec t o f a smal l busines s provision , annua l productio nvolume , togethe r wit h th e toxicit yo f th e material , i s veryimportan t whe n i t come s t o assessing th e potentia l risk s t o th e publi c health , welfare , an d emissio n contro l systemperformance . EPArequest s commen t o n wha t sales/revenu e threshold s ar e appropriat e fo r differen t fuel s an d additive s an

d wha t othe r financia l criteri a o r othe r parameter s shoul d b e considered . EPAals o request s commen t o n ho wth e requirement s fo r smal l businesse s shoul d b e differen t from thos e tha t appl yi n general . Th e Septembe r 30 , 198 8 Use r Fe e Rul e unde r TSCA§2 6 (4 0 CF R700.40 ) define d a smal l busines s concer n a s an yperso nwhos e tota l annua l sale s i n th e fisca l yea r preceding th e dat e o f submissio n o f th e applicable , § 5 notice , whe n combine d wit hthos e o f th e paren t compan

y(i f any) , ar e les s tha n $4 0 million . A simila r definitio n i s use d fo r TSCA§ 8 reporting rule s (4 0 CF R704.3) . EPArequest s commen t o n th e applicabilit yo f thes e definition s t o th e fuel s an d fue l additive s program . Producer s o f fuel s an d fue l additive s ar e strongl y encourage d t o b e certai n tha t th e annua l productio nvolume s theyhav e reporte d t o EPAunde r th e fue l an d fue l additiv e registratio n progra mar e accurat e an d current . Thi s -19

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informatio n ; i s essentia l i f EPAi s t o develop workabl e provision s fo r smal l businesses . Inaccurat e o r incomplet e informatio n coul d resul t i n les s tha noptimu m provision s an d th e possibilit ytha t fuels/additive s o r individua l producer s thereo f woul d b e preclude d fro msmal l busines s provision s sinc e informatio n wa s lacking t o demonstrat e tha t theyshoul d hav e bee nincluded . 2 . Cost/Burde n Sharing Provision s

A s wa s discusse d above , th e provision s o f §211(e)(3)(B ) provid e a mean s t o reduc e th e cos t an d burde n o f th e fue l an

d fue l additive s program ^ Thes e provision s permi t producer s o f an yfue l o r fue l additiv e whic hi s manufacture d o r processe d b ytw o o r mor e person s t o shar e cost s o r i responsibilitie s unde r th e programs o tha t requirement s ca n b e me t withou t duplicatio no f effort . Thi s involve s bot hprocedura l issue s o nho wproducer s woul d shar e th e cost s an

d burden s involve d an d programmatter s o n ho wfuel s an

d additive s coul d b e groupe d fo r purpose s o f enacting thes e provisions . Procedura l implementatio n i s i discusse d below . However , th e concep t o f grouping fo r testing purpose s ha s §211(b)(2 ) implication s wit hregard t o EPA' s approac ht o implementing protocols , s o i t wil l b e discusse d i n a separat e section .

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Wit hregard t o procedura l implementatio n o f thi s provisio n ther e ar e tw o possibl e situations . Th e firs t involve s th e cas e wher e sufficien t informatio nexist s fo r th e registratio n o f a produc t withou t th e completio n o f additiona l testing becaus e a manufacture r o r othe r entit y ha s alread

ycomplete d th e require d testing . I nthi s case , th e firs t entit yha s alread yincurre d al l necessarycost s whil e th e secon

d manufacture r migh t see k t o simpl yus e th e result s o f thi s testing a s sufficien t existing testing an d clai mexemptio n fromfurthe r testing (an d th e associate d expense) . Th e secon d cas e involve s tw o o r mor e producer s o f simila r existing o r ne wproduct s wh o nee d t o undertak e th e same testing requirement s prio r to . registration . Tw o o r mor e entitie s woul d expend th e same effor t t o accomplis h th e same resul t an d woul d us e th e limite d tes t facilitie s t o duplicat e th e same tests . Sectio n 211(e ) allow s th e Administrato r t o provid e fo r manufacturer s o f th e same fue l o r additiv e t o shar e th e cos t o f complying wit hth e regulation s an d h e ma yals o provid e fo r meuiufacturer s o f th e same fue l o r additiv e t o shar e th e responsibilitie s o f complying wit htesting regulations . T o implemen t thi s authorit yi nth e firs t case , th e manufacture r wh o conduct s test s o f a produc t woul d b e recognize d unde r §211(e)(3)(B ) a s having a righ t t o cost-sharing fromother s wh o wis ht o rel yo ntha t testing fo r purpose s o f §211 . Thes e othe r manufacturer s -21

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woul d no t b e abl e t o us e th e firs t manufacturer' s tes t result s withou t reaching an agreemen t o n sharing th e cost . Th e Agenc yinvite s commen t o nwhethe r th e provision s shoul d b e applicabl e t o provid e fo r cost-sharing whe n on e manufacture r ha s submitte d tes t result s tha t other s wis ht o rel yupo n i n meeting thei r testing obligations . I n case s wher e two o r mor e producer s nee d prospectivel yt o complet e th e same testing , theycoul d for ma consortiu

mt o complet e th e requirement s an d submi t th e result s a s a group . An y additiona l manufacturer s desiring t o rel yo ntha t testing fo r thei r produc t woul d the n b e charge d a fe e b yth e origina l producer s t o us e thes e result s rathe r tha nconduc t thei r ow

n testing . Th e Agenc yrequests , comment s regarding thi s approac han

d solicit s othe r suggestions . I nal l cases , unde r §211(b) , th e tes t result s submitte d t o EPA woul d no t b e confidential .

EPAals o invite s comment s o nsome additiona l matter s i n thi s area . Thes e cost-sharing provision s woul d no t b e expecte d t o b e availabl e fo r existing test s i f th e ful l tes t result s hav e alread ybee n published . Shoul d an y limit s b e se t fo r th e fee s tha t mayb e charge d fo r us e o f tes t informatio n an d especiall ywhe n th e test s ar e a numbe r o f year s old ? Shoul d th e reimbursemen t provision s o f § 4 o f TSCAb e considere d a mode l fo r handling cost-sharing questions ?

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EPAha s extensiv e experienc e unde r TSC A§ 4 wit h cost-sharing fo r testing . EPAha s foun d tha t person s conducting testing unde r § 4 hav e chose ni neachinstanc e t o dat e t o wor k ou t thei r ow n arrangement s fo r cost-sharing o r reimbursemen t withou t an ynee d fo r EPAinvolvement . EPA issue d regulation s i n 4 0 CF RPar t 79 1 fo r dat a reimbursement . I n spit e o f th e significan t numbe r o f tes t rule s issue d unde r TSCA , n o on e ha s invoke d an yo f th e forma l procedure s fo r dat a reimbursemen t unde r th e regulations . EPAsolicit s commen t o nwhethe r a simila r resul t i s likel yunde r th e §21 1 testing program .

» 3 . Grouping o f Fuel s an d Additive s fo r Testing

A s wa s mentione d above , t o implemen t th e §211(e)(3)(B ) provisions , th e regulation s mayinclud e criteri a t o determin e whic hfuel s o r fue l additive s ar e essentiall yth e same fo r th e purpose s o f determining potentia l publi c healt heffect s an d meeting othe r requirements . I f th e fuel s o r additive s ar e essentiall yth e same a s othe r fuel s o r additives , grouping fo r testing purpose s woul d preven t duplicativ e testing unde r §211(e)(3) . Fuel s an d additive s ar e comple xmixture s and , i n grouping them , i t i s necessary t o establis hcriteri a fo r judging i f tw o o r mor e fuels/additive s ar e essentiall yth e same . Thi s criteri a ca n initiall yinvolve evaluatio no f th e chemica l -23

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compositio n and/o r structura l activit ypropertie s o f fuels/additive s fo r th e appropriat e degre e o f sameness . Suc hcategorizatio n reduce s th e burde n o f testing , whic hi s importan t give n th e grea t numbe r o f compound s involve d an d th e lac k o f tes t facilities . Fromeac ho f thes e groups , representativ e and/o r possibl ytoxi c fuel s an d additive s coul d b e selecte d t o underg o th e testing requirements . Thi s woul d eliminat e th e nee d fo r eac hfue l an d fue l additiv e t o underg o testing . T o accomplis hthi s end , however , potentia l group s wil l nee d t o b e establishe d a s wel l a s th e criteri a b ywhic hfuel s an

d additive s wil l b e assigne d t o suc hgroups .

» Th e definitio n o f "essentiall yth e same " b ywhic h fuel s an

d additive s ca nb e groupe d ca n b e a verybroa d definitio n o r i t ca n b e narro wi nscope . Astric t definitio n woul d grou p fuel s an

d additive s according t o narro wcriteria , woul d emphasiz e th e difference s among chemicals , an

d woul d therefor e resul t i na verylarg e numbe r o f groups . O n th e othe r hand , defining "essentiall y th e same " mor e broadl ywoul d resul t i n fewe r group s wher e th e difference s betwee n fuel s an d fue l additiv e group s coul d b e greater . Unde r thi s approach , severa l representative s o f th e grou p migh t b e subjec t t o testing , wherea s onl yon e membe r mayb e i n th e forme r case . (I n bot hcases , thi s assume s adequat e informatio n doe s no t no w exist) . Fo r example , a recen t EPAtechnica l memorandum , -24

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"Analysi s o f Aftermarke t Fue l Additive s Containing Methanol " (availabl e i nDocke t No . A-90-07) , show s tha t a larg e numbe r o f th e aftermarke t fue l additive s considere d contai n almos t al l methanol ; however , ther e i s a smal l portio n tha t contain s a larg e numbe r o f othe r compound s a s well . I n trying t o grou p thes e additive s o nth e basi s o f an "essentiall yth e same " definitio ni t woul d b e necessary t o determin e i f theyshoul d b e groupe d togethe r base d o n th e fac t tha t the yal l contai nmethanol , o r theyshoul d b e spli t int o a numbe r o f subgroup s a s deeme d appropriat e base d o n th e othe r chemica l compound s and/o r structure s involved . Fo r eac hgrou p tha t i s formed , on e o r mor e representative s coul d b e selecte d for.testin g i f needed . A s ca n b e seen , grouping th e product s mor e strictl ycoul d resul t i n mor e tha t woul d hav e t o b e tested . Th e provision s o f CA A§211(f ) hav e provide d some experienc e wit hdetermining fuel s an d additive s whic har e "substantiall ysimilar " t o othe r fuel s an d additive s i na differen t setting tha t focuse s o nemissio ncontro l system effects . I n a 198 1 Interpretiv e Rul e (4 6 F R38582-38586 ; Jul y28 , 1981) , EPAha s define d anunleade d gasolin e t o b e "substantiall ysimilar " t o th e certificatio n fue l use d i n 197 5 o r late r mode l yea r vehicle s o r vehicl e engine s i f i t contain s carbon , hydrogen , an d oxygen , nitroge n and/o r sulfur i n some for mo f hydrocarbon , aliphati c ether , aliphati c alcoho l (wit hsome limitatio no ntyp e o f -25

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alcohol) , wit hfue l additive s containing onl ycarbon , hydrogen , an

d oxygen , nitrogen , and/o r sulfur , an d meet s certai n limitation s regarding th e amoun t o f fue l additive , sulfur i n the . additive , an d alcoho l presen t i nth e fuel . Fuel s no t meeting thes e criteri a ar e no t considere d "substantiall ysimilar " t o th e above-mentione d certificatio n fuel . Relate d material s canb e foun d i n th e publi c docket . EPAinvite s comment s o nwhethe r thes e determination s o r simila r approache s ar e usefu l alon e o r wit hothe r factor s fo r grouping fuels/additive s fo r testing purpose s fo r determining publi c health , emissio n contro l system , and/o r welfar e effects . Commen t i s als o invite d o n whethe r th e structur e activit yrelationshi p shoul d b e th e basi s fo r grouping .
EP Aals o plan s t o examin e it s registratio ndat a t o determin e i f the yprovid e a usefu l basi s fo r grouping fuel s an d additive s fo r testing . Th e result s o f ananalysi s t o b e conducte d pursuan t t o a contrac t wil l b e include d i nth e publi c docke t whe n available . EP Ainvite s comment s o n th e appropriat e wa yt o grou p fuel s an

d additive s an

d th e criteri a t o b e used . Th e mos t importan t concer ni n grouping fuel s an

d additive s woul d b e thei r samenes s fo r purpose s o f potentia l toxicit yan d emissio n contro l an d welfare/environmenta l effects .

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4 . Duplicativ e an d Existing Test s Unde r CA

A§211(e)(3)(C) , th e Administrato r "may " exemp t an

yfue l o r additiv e fro mth e regulation s "upona finding tha t an

yadditiona l testing o f suc hfue l o r fue l additiv e woul d b e duplicativ e o f adequat e existing testing. " Moreover , unde r §211(c)(2)(A) , th e Administrato r ca n onl ycontro l o r regulat e a fue l o nth e basi s o f al l relevan t medica l an d scientifi c evidenc e availabl e t o him .
T o structur e th e testing programan d t o determin e i f ther e i s duplicativ e testing , i t i s importan t t o obtai n result s from

existing test s o n fue l an d fue l additive s a t an earl ypoint . I t i s als o necessaryt o determin e wha t testing ha s bee n initiated . Sinc e i t typicall ytake s severa l year s fo r a repor t t o b e mad e public , t o avoi d unnecessaryduplication , i t i s importan t t o b e knowledgeabl e abou t ongoing work . Testing t o dea l wit h some o f th e health , emissio n o r welfar e effect s o f fuel s an d fue l additive s mayhav e bee n conducte d fo r variou s reason s an

d b e availabl e fromvariou s sources .
I n connectio n wit hthi s proceeding , t o hel p obtai n informatio n o n existing testing o na timel ybasis , EPAi s considering amending th e registratio n provision s i n4 0 CF R 79 , Subpar t D (implemente d unde r §2ll(b)(D) , t o ensur e tha t producer s provid e a summaryo f an ypublishe d testing -27

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o r a detaile d repor t o f unpublishe d result s don e b ythe produce r including test s fo r EPAo r othe r governmen t agencie s tha t relat e t o healt han d othe r effect s covere d b y §211 . Thi s include s carcinogenicity , mutagenicity , teratogenicit yan d othe r healt heffect s o f ra w fuels/additives , combustio n an d possibl yatmospheri c transformatio n product s a s wel l a s informatio no nth e effect s o f th e emission s o n th e emissio n contro l system , th e environment , an d th e publi c healt han d welfar e i n general . Furthermore , a s par t o f th e possibl e program protoco l describe d below , EPAmayrequir e th e manufacturer s t o conduc t a literatur e searc han d submi t studie s o r a summaryo f availabl e informatio nrelating t o th e hazard s an d impact s o f th e fuel(s ) o r additive(s ) th e manufacture r produces . Suc hinformatio n ca n b e considere d reasonabl e an d necessaryt o determin e th e exten t t o whic hemission s affec t th e publi c healt han d welfar e unde r §211(b)(2) .

EP Asee s thi s a s a ke yprovisio n an d invite s comment s o n thi s measur e an d o nth e criteri a an d procedure s tha t shoul d b e use d t o determin e whethe r an yfue l o r additiv e shoul d b e exemp t o n th e ground s tha t adequat e existing informatio n exists .
D . Healt hTesting Protocol s an d Requiremen t Issue s Sectio n §211(b)(2 ) provide s tha t test s ar e t o b e -28

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conducte d according t o tes t procedure s an d protocol s establishe d b

yth e Administrator . Th e sectio n coul d b e read a s simpl yrequiring adherenc e t o specifi c guideline s identifie d b

yEPA , rathe r than requiring EPAt o establis h specifi c tes t plan s o r procedure s i n everycas e befor e testing i s done . EPAmigh t provid e fo r th e us e o f generall yaccepte d o r bes t availabl e scientifi c tes t guideline s o r plan s i n th e absenc e o f a requiremen t fo r a specifi c procedure . Th e statut e als o doe s no t specif yth e exten t t o whic hth e tes t requirement s shoul d b e mandate d b y regulation , identifie d i nguideline s a s acceptabl e models , o r establishe d o n a case-by-cas e basis .

» Give n th e larg e numbe r o f fuel s an d fue l additive s an d th e compound s containe d therei nan d th e potentia l numbe r o f healt heffect s endpoints , identifying appropriat e tes t guideline s i s important . Thi s sectio nreview s th e currentl yavailabl e healt htesting an d ris k assessmen t guidelines , th e factor s bearing o nth e nee d t o develop guidelines , an

d ask s fo r comment s o nth e bes t approac ht o mee t th e requirement s o f th e Act . 1 . Existing Healt hEffect s Testing Protocol s Ther e ar e severa l existing source s o f establishe d healt htesting guidelines . Thes e includ e th e TSCA , Healt h Effect s Testing Guideline s (4 0 CF RPar t 798) , Federa l -29

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Insecticide , Fungicide , an d Rodenticid e Ac t (FIFRA ) Toxicolog

yDat a Requirement s (4 0 CF R158.340) , an d the Organizatio n fo r Economi c Cooperatio n an d Developmen t (OECD ) Guideline s fo r Testing o f Chemicals.[2 ]

I n addition , ther e hav e bee nsevera l studie s commissione d throughou t th e pas t 1 0 year s whic hwer e aimed a t determining a propose d approac hfo r testing o f fuel s an d additives.[3,4,5,6 ]

[2 ] "OECD Guideline s fo r Testing o f Chemicals" ; ISB N 92-64-12900-6 ; 1981 . [3 ] "Possibl e Approache s t o th e Healt hEffect s Testing o f Fuel s an

d Fue l Additives" ; Littp nBionetics , Inc ; Technica l Directiv e No . 008 , EPAContrac t No . 68-02-3682 ; Draf t Report , Jul y1983 . [4 ] "Us e o f Short-TermGenotoxi c Bioassay s i nth e Evaluatio n o f Unregulate d Automobil e Emissions" ; Litto n Bionetics , Inc. ; EPAContrac t No . 68-02-3682 ; Fina l Report , October , 1983 . [5 ] "Validatio n o f Chemica l an d Biologica l Technique s fo r Evaluatio n o f Vapor s i n Ambien t Air/Mutagenicit y Testing o f Twelv e (12 ) Vapor-Phas e Compounds" ; EPA Contrac t No . 68-02-3170-082 ; EPA-600/1-84-005 ; March , 1984 . [6 ] "Testing fo r Healt hEffect s o f Fuel s an d Fue l Additives" ; Southwes t Foundatio n fo r Researc han d Education ; EPAContrac t No . 68-02-2286 ; Draf t Report , 1978 .

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Eac ho f the fiv e set s o f establishe d healt htesting guideline s mentione d above represent s generally-formulate d procedure s fo r laboratorytesting o f aneffec t o r characteristi c deeme d importan t fo r th e evaluatio no f healt han

d environmenta l hazard s o f a chemical . Th e healt h effect s tha t ar e include d ar e primaril yacute , subchronic , an d chroni c toxicolog y(dermal , oral , an d inhalation ) a s wel l a s oncogenicit yan d geneti c toxicology .

i Thes e protocol s provid e guidanc e an d t o a varying degre e detail s o n acceptabl e model s o f testing design , bu t mor e specifi c guidanc e mayb e neede d i nparticula r cases . However , th e potentia l scop e o f th e fue l an d fue l additiv e testing progra

mi s suc htha t providing thes e specific s beforehand i n eac hcas e i s generall yimpractical . EPA invite s comment s o n th e adoptio no f thes e guideline s fo r fue l an d fue l additiv e testing an d o n th e exten t t o whic h mor e specifi c guidanc e i s neede d an d th e manne r i n whic hi t shoul d b e provided . Whil e resourc e intensiv e fo r EPAan d time consuming , on e possibl e approac hfo r th e mor e comple xan d comprehensiv e test s i s t o provid e mor e specifi c guidanc e o n a case-by-cas e basis . Thi s approac hmigh t requir e th e produce r t o prepar e tes t plan s fo r EPAapprova l a s i s

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presentl yuse d b

yEPAi nit s TSCA§ 4 tes t rul e for dibenzo-para-dioxins/dibenzofuran s (4 0 CFR766) . Alternatively , EPAmigh t allowth e produce r t o develop th e plan s an

d conduc t suc htesting withou t EPAapprova l bu t wit hEPAapprova l o f th e acceptabilit yo f th e result s an d retesting i f unacceptable .
Becaus e o f th e numbe r o f fuels/additive s tha t coul d b e tested , i t i s desirable , i f possible , t o hav e mode l guideline s tha t ca n b e use d withou t th e nee d fo r a uniqu e pla n an

d EPAreviewi n eac hcase . Ar e th e presen t guidelines , particularl yth e TSCAguidelines , sufficien t t o achiev e thi s goal ? Shoul d th e guideline s b e presume d t o b e appropriat e unless , i n a particula r case , a manufacture r show s th e nee d fo r o r appropriatenes s o f using differen t guidelines ?

Amajo r issu e i s th e availabilit yan d appropriatenes s o f variou s guideline s fo r testing emissions/combustio n products . A s i s discusse d an d reference d below , th e carcinogenicit yo f diese l fue l a s combuste d ha s bee n tested . D o th e tes t protocol s use d i nthes e studie s provid e a n appropriat e mode l fo r testing o f th e combustio n product s o f fuel s an d fue l additives ? Wha t procedure s shoul d EPAus e fo r protoco l reviewan d a t wha t poin t shoul d thes e review s occur i f needed ?
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I n additio n t o th e healt heffect s testing guidelines , EPAha s als o issue d five ris k assessmen t guidelines : 1 ) "Guideline s fo r Carcinoge n Ris k Assessment " (5 1 F R 33992-34003 , Septembe r 24 , 1986) ; 2 ) "Guideline s fo r Mutagenicit yRis k Assessment " (5 1 FR34006-34012 , Septembe r 24 , 1986) ; 3 ) "Guideline s fo r th e Healt hRis k Assessmen t o f Chemica l Mixtures " (5 1 F R34014-34025 , Septembe r 24 , 1986) ; 4 ) "Guideline s fo r th e Healt hAssessmen t o f Suspec t Developmenta l Toxicants " (5 1 F R34028-34040 , Septembe r 24 , 1986) ; an

d 5 ) "Guideline s fo r Exposur e Assessment " (5 1 F R 34042-34054 , Septembe r 24 , 1986) . Also , during th e las t fewmonth s EP Aha s propose d ne wguideline s fo r reproductiv e ris k assessment s an d a ne wguidelin e tha t supplement s th e guidanc e i n th e 198 6 exposur e guidelines . Thes e are : l ) "Propose d Guideline s fo r Assessing Mal e Reproductiv e Ris k an d Reques t fo r Comments " (5 3 F R24850-24869 , Jun e 30 , 1988) ; 2 ) "Propose d Guideline s fo r Assessing Femal e Reproductiv e Risk ; Notice " (5 3 F R24834-24847 , Jun e 30 , 1988) ; 3 ) "Propose d Guideline s fo r Exposure-Relate d Measurement s an

d Reques t fo r Comments ; Notice " (5 3 F R 48830-48853 , Decembe r 2 , 1988) ; an d 4 ) "Propose d Amendment s t o th e Guideline s fo r th e Healt hAssessmen t o f Suspec t Developmenta l Toxicants ; Reques t fo r Comments , Notice " (5 4 F R9386—9403 , Marc h6 , 1989) . EPArequest s commen t o n th e applicabilit yo f th e ris k assessmen t guideline s t o th e programt o b e develope d unde r §211(b)(2) . -33

-2 . LaboratoryCapabilitie s

Asecon

d importan t facto r t o conside r i s the capabilit yo f th e nation' s testing facilitie s t o handl e the volume o f testing tha t coul d potentiall yb e generate d bot h i n th e nea r term

an d i n th e future . EPAinvite s commen t on th e existing capacit yfo r suc htesting a s wel l a s th e capabilitie s among testing facilities . I f onl ya limited numbe r o f laboratorie s ar e capabl e o f performing a certai n test , th e prioritie s fo r testing mus t b e carefull y considered , especiall yi n th e shor t term , s o a s no t t o undul yburde n producer s an d testing facilitie s an d t o ensur e soun

d tests . Fo r example , th e EPAstaf f i s awar e o f onl yapproximatel ythre e facilitie s capabl e a t presen t o f conducting inhalatio n studie s wit hvehicula r combustio n emissions . EP Aespeciall yinvite s commen t fro mth e scientifi c communit yo nth e capabilit yo f tes t laboratories , an

d i s no wconducting anindependen t stud yo f curren t capabilities . Thi s report , entitled , "EP ACensu s o f th e Toxicologica l Testing Industry" , wil l b e place d i n th e docke t whe n completed .

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3 . Healt hEffect s Endpoint s

A s discusse d earlier , th e CA Aprovide s fo r th e Administrato r t o requir e testing t o determin e potentia l publi c healt heffect s including carcinogenicity , mutagenicity , an d teratogenicity . Testing i s no t necessaril yt o b e limite d t o thes e healt heffect s but , rather , mayinclud e testing fo r systemi c toxicity , cardiovascula r an d inhalatio n effects , neurotoxicity , metaboli c effects , acut e effect s (oral , dermal , inhalation) , effect s o n mucou s membranes , etc . Th e legislative historyindicate s tha t th e testing protocol s shoul d b e "reasonabl ycomprehensive". * H.R . Rept . No . 95-294 , 95t hCong. , 1s t Sess . 30 9 (1977) . Thi s rulemaking wil l determin e whic hhealt heffec t endpoint s nee d t o b e include d a s par t o f th e testing program . 4 . Exposur e Route s an d Level s Along wit hdetermining whic hhealt heffec t endpoint s t o includ e i n th e program , th e route s an d level s o f exposur e t o fuels , fue l additives , an d thei r emission s mus t als o b e decide d fo r anima l testing . Peopl e ar e expose d t o th e rawfue l o r additiv e itsel f throughaccidenta l ingestio n o r eye an d ski n contact . Th e inhalatio no f vapor s als o cause s contac t wit hth e rawfue l o r additive . -35

-Combustio n product s a s wel l a s atmospheri c transformatio n

product s o f th e emission s o f fuel s an d additive s ar e usuall yinhale d o r maycaus e a wid e arra yo f effects . Thes e exposur e scenario s indicat e tha t th e mos t likel y route s o f exposur e woul d b e inhalation , oral , dermal , an d ocular . Beside s rout e o f exposure , i n dealing wit hemission s o f fuels/additives , i t i s als o importan t tha t th e pollutan t level , duration , an d patter n o f exposur e fo r th e tes t protocol s b e determined . Concentration s use d ar e usuall y muc hhighe r i n laboratorytest s tha n encountere d i n th e environmen t becaus e th e laboratorytests * ar e conducte d o n a smal l numbe r o f animal s an d ar e suppose d t o provid e result s mor e quickl ytha n theycoul d b e observe d i nth e natura l situation . Exposur e ca nb e a singl e exposure , long term , o r ca n occur a t intervals . Periodi c exposur e canoccur a t regula r o r varyin g intervals . I naddition , during periodi c exposure , th e concentratio n ca neithe r b e uniformo r increasing/decreasing . Sinc e significan t exposur e t o moto r vehicl e fuel s an d fue l additive s i s i n th e for mo f combustio n an d atmospheri c transformatio n product s presen t i nth e ai r theybreathe , i t i s appropriat e tha t thes e b e considere d i nan ytesting program . Atmospheri c transpor t an d transformatio n -36

-P.3 8

o f emission s maylea d t o increase d toxicity . I naddition , th e fue l formulatio n itsel f impact s ai r qualit yan d healt h effect s bycontributing toward ozone , formaldehyde , an d othe r toxic s and/o r carcinogens . I n testing combustio n products , ho wshoul d th e tes t sampl e b e determined ? Shoul d th e whol e exhaust , fractionate d samples , o r some combinatio n o f thes e b e teste d and , i f so , wha t criteri a shoul d b e applied ? T o wha t exten t an d i n wha t wayshoul d thi s progra

m conside r atmospheri c transformatio nproducts ?

5 . TSCAGuideline s an d Tes t Criteri a

EPAi s considering using some o f tji e basi c approache s an d tes t procedure s implemente d unde r TSCAfo r evaluating chemica l substance s a s guidanc e i n developing testing criteri a an

d tes t method s fo r fuel s an d fue l additives . Th e underlying testing philosoph yan d regulatoryapproac h o f TSCAwoul d b e use d a s guidanc e i ndeveloping testing criteri a an

d tes t method s fo r us e i n th e fuel s an d fue l additive s testing program . Th e standardize d guideline s fo r healt heffects , environmenta l effects , an d chemica l fat e test s ar e foun

d a t 4 0 CF RPart s 79 5 through798 . Unde r § 4 o f TSCA , testing o f chemical s t o develop dat a i s require d i f th e Administrato r make s certai nfinding s a s

-37

-describe d i n TSCA§4(a)(l)(A ) o r (B ) . I n TSCA§ 4 tes t

rules , EPAspecifie s th e individua l tes t requirements . A generall yformulate d se t o f tes t procedures , known a s TSC A tes t guidelines , ar e usuall yadopte d a s tes t requirements . Thes e guideline s specify , whe nappropriate , tiere d testing scheme s whic hus e short-term , les s expensiv e test s t o trigge r subsequent , mor e comple xtest s o r batterie s o f tests . (See , e.g. , 4 0 CFR§ § 799.250 0 an d 3175 ) Thes e longer-ter

m tests , suc ha s cance r bioassays , ar e muc hmor e costly . Determination s o f whethe r longer-ter mtesting i s necessaryar e mad e o n a n individua l chemica l basis . Unde r TSCA§5 , EP Ascreen s ne wchemica l substance s befor e manufactur e i s permitte d t o asses s thei r potentia l t o caus e injuryt o huma n healt ho r th e environment . Usin g finding s simila r t o thos e unde r TSCA§4 , i f EP Afind s tha t availabl e informatio n i s insufficien t t o permi t reasonabl e evaluatio n o f th e healt han d environmenta l effect s o f a ne w substanc e and , i n th e absenc e o f suc hinformation , activitie s involving th e substanc e maypresen t an unreasonabl e risk , EPAmayregulat e activitie s involving th e ne wsubstanc e pending developmen t o f sufficien t information . I n addition , EPAmayregulat e a ne wsubstanc e wher e th e informatio n i s insufficien t an d th e substanc e wil l o r ma yb e produce d i n substantia l quantitie s an d ther e i s o r mayb e significan t o r substantia l huma nexposur e t o

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th e chemica l o r th e substanc e mayreasonabl yb e anticipate d t o ente r th e environmen t i nsubstantia l quanitities . Suc h testing mus t b e complete d an d evaluate d t o EPA' s satisfactio n befor e unrestricte d commercia l manufactur e or impor t mayoccur . Test s ar e selecte d fo r thes e chemical s o n th e basi s o f th e healt ho r th e environmenta l en d point(s ) identifie d during th e assessment . Specifi c test s ar e frequentl ybase d o nth e TSCATes t Guidelines .

EPAinvite s commen t o n th e suitabilit yo f th e TSCA criteri a i n developing testing requirement s an d tes t method s fo r fuel s an d fue l additives . Th e legislativ e historyo f §211(e ) indicate s tha t EPAshoul d us e relativel y inexpensive bu t reliabl e tes t method s insofa r a s possible . H.R . Rept . No . 95-294 , 95t hCong . 1s t Sess . 30 9 (1977) . Comment s ar e particularl yinvite d o n th e suitabilit yo f th e test s use d i n th e TSCAtes t rule s a s reliabl e tes t method s fo r us e unde r §21 1 an d o n th e criteri a tha t shoul d appl yt o fuel s an

d additive s wit ha highproductio nvolume an d a significan t o r substantia l leve l o f exposure .
E . Analysi s o f Sectio n 21 1 Time Reguirement s fo r Submitta l o f Requisit e Informatio n Sectio n 211(e ) require s tha t th e "requisit e information " b e provide d t o EPAb yeac hmanufacture r withi n thre e year s fo r existing fuel s an d fue l additives , an d
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-P.4 1

prio r t o registratio n fo r thos e no t registere d a t th e time th e rul e i s promulgated . Th e legislativ e historyfo r thi s provisio n indicate s tha t al l o f th e requirement s ar e mandatory , a s ar e th e date s b ywhic hth e require d tes t informatio n mus t b e submitte d b yth e manufacturer , subjec t t o specifi c statutoryexceptions . H.R . Rept . No . 95-294 , 95t hCong. , 1s t Sess . 30 8 (1977) .
However , th e same repor t o f th e Hous e Commerc e Committe e als o indicate s tha t th e regulation s ar e no t intende d t o b e "undul yburdensome" . Th e Administrato r i s expecte d "t o tak e cost s int o accoun t i npromulgating tes t requirements" . H.R . Rept . No . 95-294 , 95t hCong . 1s t Sess . 30 9 (1977) . Th e Hous e Committe e als o expecte d EPAt o utiliz e a s fa r a s possibl e th e "[rlrelativel yinexpensiv e bu t reliabl e tes t methods " whic har e becoming "increasingl y available" . Th e "paramoun t interest " i nprotecting th e publi c healt hrequire s tes t protocol s whic har e "reasonabl y comprehensive " wit hrespec t t o a numbe r o f healt heffects . Id .
A s wa s discusse d above , ther e appear s t o b e some tensio n betwee n th e ful l potentia l scop e o f th e testing requiremen t o f §21 1 an d th e Congressiona l goa l tha t th e implementing regulation s no t b e "undul yburdensome" . Specia l difficultie s ca naris e i f comprehensiv e testing o f

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-P.4 2

al l existing fuel s an d fue l additive s mus t b e undertake n an d complete d withi n thre e year s o f th e promulgatio no f th e regulations . Suc ha fixed time schedul e ca nb e detrimenta l t o conducting soun d an d adequat e scientifi c studies . Long-ter

mstudie s o f healt heffect s can ofte n tak e longe r than thre e years . Inhalatio ntest s fo r carcinogeni c effect s mayno t showeffect s unti l afte r 3 0 month s o f exposure . [7 ] Th e additiona l time t o se t up th e stud yan d evaluat e tes t result s woul d effectivel ypreclud e submissio n o f th e result s withi n thre e years . Anarro winterpretatio n o f thi s provisio n woul d limi t testing t o thos e test s tha t ar e possibl e t o complet e i nthre e year s rathe r tha ntest s tha t mayb e mor e adequat e an d appropriat e t o determin e potentia l publi c healt han d emissio neffects .
A s discusse d above , a three-yea r time perio d t o complet e an

yrequire d testing woul d als o strai nth e presentl yavailabl e laboratoryfacilitie s fo r conducting studies , particularl ychroni c studie s suc ha s inhalatio n studies . Whil e mor e informatio n o nlaboratorycapabilit y i s needed , th e presen t indication s ar e tha t th e limite d tes t facilitie s availabl e mak e i t impractica l t o complet e al l testing o f al l fuel s an d fue l additive s withi nthre e years . [7 ] "Healt hAssessmen t Documen t fo r Diese l Emissions; " Offic e o f Researc han d Development ; U.S . Environmenta l Protectio n Agency ; Draf t Report ; May25 , 199 0I t shoul d b e emphasize d tha t a t thi s poin t muc h

remain s t o b e learne d abou t th e exten t o f th e additiona l testing tha t wil l b e needed . Manufacturer s mayb e exempte d fromfurthe r testing i f adequat e existing testing ha s alread ybee n conducted . Th e exten t an d adequacyo f the existing testing wil l hav e t o b e determined . Cost-sharing b ymanufacturer s i s encourage d b yth e statut e an

d thi s shoul d reduc e th e amoun t o f testing require d fo r essentiall yth e same substances . Furthermore , th e legislative historyencourage s th e us e o f relativel y inexpensive bu t reliabl e tes t method s i ns o fa r a s i s possible . Still, : some additiona l testing i s likel yt o b e neede d an d thes e need s maysurpas s th e capabilit yo f laboratorie s t o complet e withi n thre e years . EPAinvite s commen t o n appropriat e way s t o dea l wit hth e tensio n betwee nth e time neede d for : adequat e testing an d th e limite d laboratory capabilitie s o n th e on e hand an d th e statutorytim e perio d fo r submitting requisit e informatio no n th e other . Th e Agenc yi s exploring severa l possibl e approache s an d thes e ar e outline d belo wfo r discussion , along wit hrelate d issues . Comment s ar e invite d o nwhethe r an yo f thes e approache s shoul d b e pursued , o r o nwhethe r ther e ar e alternativ e approache s tha t shoul d b e considered .

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1 . Requisit e Informatio n

On e approach , whic happear s soun d an d consisten t wit h th e Act , woul d b e t o vie wth e requiremen t i n§211(e ) tha t "requisit e information " b e submitte d i nthre e year s a s applying t o th e informatio n an d tes t result s tha t EPA determine s i s neede d fo r regulatorydecisio nmaking an d can b e complete d withi n th e thre e years . Test s whic hcanno t b e complete d withi n thre e year s woul d nee d t o b e submitte d a s soo n a s possibl e afte r completion . Th e statutorytex t o f §211(e)(2 ) i refer s t o th e submissio no f "requisit e information " require d byregulatio n t o implemen t th e authorit yunde r §211(b) . Th e authority , unde r §211(b ) tha t EPAi s require d t o implemen t b y§211(e ) state s tha t EPAmay requir e manufacturer s t o "conduc t tests " t o determin e "potentia l publi c healt heffects, " an d t o submi t suc hothe r informatio n "a s i s reasonabl e an d necessary " t o determin e emissio n contro l an d welfar e effects . Whil e §2ll(e ) n o longe r leave s EPAan ydiscretio no nwhethe r t o implemen t §211(b) , subsectio n (b ) relie s o nEP At o exercis e judgmen t i n determining th e testing neede d t o mee t th e statutory aims .

I n th e regulation s implementing §211(b) , EPAwoul d exercis e it s judgmen t t o establis ha fue l an d fue l additive s programtha t wil l mee t th e testing requirement s -43

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o f th e Act . Unde r suc han approach , producer s o f al l existing fuel s an d fue l additive s woul d hav e t o submi t certai n informatio n withi nthre e year s o f promulgatio no f th e fina l regulation . Thi s submissio nwoul d contai nth e requisit e informatio n calle d fo r b yth e regulation s including the result s o f screening test s an d an yothe r testing require d and / or previousl ycompleted . Long-term test s woul d hav e t o b e submitte d i f require d an d i f possibl e t o complet e them . Late r submission s o f complete d studie s woul d b e permitte d whe ni t i s no t possibl e t o submi t adequat e studie s i ntha t tim e perio d a s discusse d above . Th e obligatio n o f manufacturer s "t o conduc t tests " woul d b e fulfille d b ya nundertaking to.complet e test s a t a late r time whe n i t i s no t possibl e t o finis hth e studie s i n th e initia l period . I n addition , th e test s woul d hav e t o b e complete d an

d submitte d t o EPAbyan yspecifi c dat e se t b yEPAi n a notic e t o th e manufacturer s o r publishe d i n th e Federa l Register . Submissio n o f studie s afte r th e initia l three-yea r perio d woul d als o b e permitte d whe nadequat e laboratoryfacilitie s ar e no t availabl e t o conduc t test s i n tha t time perio d an d i s otherwis e neede d t o mee t th e Congressiona l goals . EPAwoul d conside r identifying prioritie s fo r completing studie s whe n ther e ar e insufficien t testing facilities . Suc hanapproac hi s als o i n accordanc e wit h§211(b)(3 ) whic hprovide s tha t registrant s wil l giv e assurance s tha t the ywil l submi t

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-additiona l informatio nwhic hreflect s "change s i n the

informatio n required " fo r registration . Furthermore , a s discusse d above i nconnectio nwit hthe methano l petition , th e Agenc yals o ha s th e optio n t o us e it s authorit yunde r TSCAi nconjunctio nwit h§21 1 t o ensur e tha t adequat e testing i s submitted . TSCAmigh t b e use d t o provid e additiona l assuranc e tha t studie s ar e complete d an d submitte d o n a timel ybasi s especiall ywhe nth e test s tak e longe r tha n th e thre e years . 2 . Three-Yea r Tes t Perio d * Anothe r possibilit yi s tha t th e requiremen t i n§211(e ) fo r submitting requisit e informatio n i nthre e year s fo r registere d fuel s shoul d b e read t o appl yonl yt o th e typ e o f test s an

d informatio ntha t ca nb e complete d an d submitte d i n thre e years . Sinc e Congres s expecte d th e requiremen t t o b e me t i nthre e years , Congres s mus t hav e envisione d th e us e o f test s tha t ca nb e complete d withi n thi s time period . I n thre e year s i t i s mor e feasibl e t o complet e literatur e searches , screening studies , an d short-ter

mstudie s a s woul d b e consisten t wit ha tie r testing approach . Thi s typ e o f informatio nca n als o hel p th e Agenc ymak e a preliminaryassessmen t o f th e potentia l fo r publi c health , emissio n contro l an d welfar e -45

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effects . Th e informatio n canguid e th e Agency' s decisio n making an

d hel p t o identif yth e nee d fo r furthe r testing . I f studie s tak e longe r tha nthre e year s t o complete , they woul d no t b e subjec t t o th e §211(e ) requirement . I f additiona l testing i s required , th e Agenc ycoul d us e it s authorit yunde r TSCAt o requir e th e submissio n o f complete d studies . Moreover , §211(b)(2 ) an d (3 ) ca n b e viewe d a s authorit yunde r whic hth e Agenc yca n continu e t o requir e additiona l testing wheneve r neede d eve ni f th e test s canno t b e complete d i n th e thre e yea r perio d identifie d i n §211(e) . 3 . Enforcemen t Discretio n Whil e perhap s no t preferred , anothe r approac hwoul d recogniz e tha t whil e §21 1 require s th e submissio no f al l requisit e informatio n withi n thre e years , th e Agenc yha s discretio n i n taking enforcemen t action . Th e Agenc ycoul d issu e guideline s tha t woul d recogniz e that , absen t unusua l circumstances , enforcemen t actio nwoul d no t b e an appropriat e priorit ywhe nmor e tim e i s neede d t o complet e studie s o r whe n th e limit s o n laboratoryfacilitie s delay th e completio n o f studies . I n thes e guidelines , th e Agenc y coul d identif yprioritie s base d o n publi c healt hfactor s fo r having test s completed . Th e ai mwoul d b e t o ensur e earl ytesting o f substance s wit hth e greates t potentia l fo r

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-extensiv e advers e effects . Se e Heckle r v . Chanev , 47 0 U.S .

82 1 (1985) , an

d Cutle r v . Haves , 81 8 F.2 d 87 9 (D.C . Cir . 1987) . 4 . TemporaryRegistration s Finally , ther e i s on e allie d issu e relate d t o requirement s fo r submissio no f th e requisit e information . Whe n a particula r fue l o r fue l additiv e ha s no t previousl y bee n registered , bu t i t i s essentiall yth e same a s a registere d fue l o r additiv e fo r whic htesting i s stil l ongoing , shoul d a temporaryregistratio neve r b e availabl e fo r th e ne wfue l o r additiv e whil e th e testing i s bein g completed ? Sectio n 211(e ) allow s registere d fuel s an d additive s thre e year s t o submi t th e requisit e informatio n bu t i t require s informatio n regarding ne wfuel s an d additive s prio r t o registration . Atemporaryregistratio n i n thi s circumstanc e woul d hel p guar d agains t anti-competitiv e effect s fromth e testing requiremen t whe n th e substance s pos e substantiall ysimila r risks . Shoul d temporaryregistration s b e availabl e i nthes e o r an yothe r circumstances ? Wha t lega l analyse s woul d suppor t thei r availability ?

EP Aseek s comment s o n al l o f thes e approache s an d consideration s i n developing a pla n t o implemen t §211 . EPA

-47

-i s stil l i n th e proces s o f developing it s regulatory

approach , an

d i s intereste d i n suggestion s fo r an yothe r approache s tha t shoul d b e considered .
F . Othe r Progra

mIssue s 1 . Lo wVolume Consideratio n

A s par t o f establishing protocol s an d determining potentia l risks , EP Ai s considering specia l provision s i f th e overal l industry-wid e annua l productio nvolum e i s les s tha n a give n threshold . Lo wproductio nvolume s usuall y resul t i n lowexposure s an d thu s a diminishe d ris k an d nee d fo r comprehensiv e testing . O f course , th e potenc yo r toxicit yo f th e compound s involve d woul d als o hav e t o b e considered . Comment s ar e requeste d o nthi s subject , including wha t exception s woul d b e appropriat e an d informatio n t o suppor t an yspecifi c definitio n o r exceptio n suggeste d i n th e comment . EP Aals o request s commen t o nth e applicabilit yo f th e criteri a use d unde r TSCAfo r differentiating lowvolume , smal l busines s entitie s from large r entities . 2 . Reporting Reguirement s

An ytesting programtha t i s develope d wil l entai l some -48

-P.5 0

degre e o f reporting . Exactl yho wmuc han d i nwha t form thi s informatio n shoul d b e submitte d need s t o b e established . Currently , fo r purpose s o f registration , marketer s o f fuel s an d additive s mus t submi t a fue l o r additive notificatio n for mcontaining suchinformatio na s th e commercia l name , chemica l composition , percen t b y weigh t o f eac hcomponent , an d purpos e i nuse . Thi s informatio n i s submitte d t o EPAo n a standard form . Wit h respec t t o th e additiona l informatio n tha t wil l nee d t o b e provide d onc e testing regulation s ar e promulgated , ho w shal l thi s informatio n b e submitted ? EPAdoe s no t intend t o accep t summarie s o f unpublishe d data ; therefore , a detaile d repor t woul d b e necessary . Fo r researc htha t ha s bee n publishe d i n peer-reviewe d literature , EPAbelieve s a summaryo f th e repor t wil l b e adequate . Shal l thi s informatio n b e submitte d o nstandard form s o r shal l th e forma t b e th e responsibilit yo f th e registrant ? Th e Agenc y request s comment s o n th e reporting detai l necessaryan d o n th e typ e o f forma t t o use . 3 . Evaluatio n o f Tes t Result s an d Determinatio no f RegulatoryAction . Onc e adequat e test s hav e bee ncomplete d an d th e requisit e informatio nha s bee nsubmitte d t o EPA , th e Agenc y wil l nee d t o asses s th e submission s t o b e sur e adequat e testing ha s bee n don e an d t o determin e whethe r an yfurthe r -49

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testing or regulatoryactio n i s needed . On e valu e o f the testing progra

mi s th e informatio n i t provide s t o the decisio n making process . I n addition , §211(c ) provide s that , base d o n th e informatio nobtaine d unde r §211(b) , th e Agenc ymaycontro l o r prohibi t fuel s o r fue l additive s whic h"ma

yreasonabl yb e anticipate d t o endange r th e publi c healt ho r welfare " o r impai r emissio n contro l systems . Befor e taking an

ysuc hactio nth e Administrato r mus t conside r al l relevan t informatio n available , including othe r mean s o f achieving emissio nstandards . Th e Administrato r mus t als o conduc t a cost-benefi t analysi s comparing emissio n contro l system s tha t requir e th e propose d contro l o r prohibitio n wit hthos e tha t d o not . I n addition , unde r §211(c)(l)(C) , th e Agenc ycanno t prohibi t th e fue l o r additiv e i f th e restrictio nwoul d lead t o th e us e o f an

yothe r fue l o r additiv e whic hwil l endange r th e publi c healt ho r welfar e t o th e same o r greate r degree . If , however , a mor e suitabl e substitut e became o r wa s availabl e tha t wa s les s dangerou s t o th e publi c healt hor welfare , the n actio n coul d b e take nt o restric t th e mor e hazardou s fuel/additive . Thes e determination s cal l fo r carefu l analysi s an d considerabl e information . Th e starting basi s fo r judging wha t actio n i s neede d i s th e existenc e an d degre e o f ris k pose d t o th e publi c healt han d welfar e o r emissio n contro l
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system . EPAinvite s commen t o nth e appropriat e proces s i t shoul d us e t o evaluat e tes t result s submitte d unde r §211(b ) t o determin e th e adequacyo f th e testing done , an d th e existenc e o f a ris k t o th e publi c healt han d welfar e an

d th e appropriat e regulatoryactio n t o b e take ni nligh t o f th e constraint s identifie d i n§211(c) . On e possibl e alternativ e woul d b e fo r EPAt o evaluat e th e tes t result s a s an interna l proces s a s par t o f a determinatio n whethe r furthe r testing o r regulatoryactio n i s necessary . Unde r thi s approach , i f EP Adecide d a contro l o r ba n o f th e fue l o r additiv e wa s necessary , i t woul d commenc e rulemaking unde r §2il(c) . I f i t decide d n o regulatoryactio n wa s required , n o forma l announcemen t woul d b e mad e an

d n o forma l publi c evaluatio nwoul d b e mad e b yEPAo f th e tes t result s submitted . Th e tes t result s themselve s woul d b e publi c unde r §21l(b) .
An alternativ e approac hwoul d b e fo r EP At o establis h a forma l reviewproces s t o evaluat e th e tes t result s o na scientifi c basis , t o determin e th e nee d fo r mor e tests , an d announc e publicl yth e exten t t o whic hth e studie s submitte d ar e adequat e an

d eithe r showo r d o no t showa potentia l publi c healt hris k o r welfar e effec t an d th e degre e o f ris k involved . Suc ha revie wproces s ma yo r ma yno t involv e participatio n byoutsid e scientifi c expert s t o advis e EPA . -51

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Commen t i s invite d o n whethe r th e Agenc yshoul d establis ha forma l reviewproces s t o evaluat e th e result s o f th e testing don e an

d th e for

man yreviewshoul d take , an d th e prioritie s fo r reviewing th e tes t result s fo r differen t categorie s o f fuel s an d fue l additives . Consequence s o f Failur e t o Submi t Requisit e Informatio n Whe n th e §211(b ) regulation s ar e issued , EP Awil l nee d t o ensur e tha t suc hregulation s ar e followe d an d th e requisit e informatio ni s submitted . Th e CA Acontain s specifi c provision s tha t nee d t o b e considere d i nensuring complianc e wit h§211 . Unde r §2ll(d) , th e manufacture r ca n b e assesse d a $10,00 0 civi l penalt yfo r eac han d everyday o f failur e t o submi t informatio nrequire d unde r subsectio n (b) . I n addition , unde r §211(e) , a ne wfue l o r fue l additiv e i s t o provid e th e requisit e informatio n prio r t o registration . Sectio n 211(c ) als o provide s fo r th e issuanc e o f regulation s t o restric t th e us e o f fuel s an d fue l additive s unde r certai n conditions . Sectio n211(e ) provide s tha t th e Agency' s regulation s "shal l require " th e submissio no f requisit e informatio n withi nth e prescribe d time frame , an d th e legislativ e historyo f §211(e ) suggest s tha t i f th e requisit e informatio n i s no t submitte d withi n thre e year s -52

-fo r registere d fuel s an d additive s th e Agency' s regulation s "shoul d provid e tha t suc hregistratio nshal l b e deeme d t o b e revoked" . H.R . Rept . No . 95-294 , 95t hCong. , 1s t Sess . 30 8 (1977) . Thi s provisio nca n b e viewe d a s authorizing regulation s tha t provid e fo r revocatio n whe nth e requisit e informatio n i s no t provided . I f th e regulation s provid e fo r revocatio n o f th e registratio n, EPAinvite s commen t o n th e procedura l safeguard s tha t shoul d b e provide d an d o n whethe r an

yadministrativ e procedure s shoul d b e afforde d i n advanc e befor e an

yregistratio nfo r an existing fue l o r additiv e i s considere d revoked . * Lastly , EP Ainvite s commen t o n th e consequence s tha t shoul d followwhe n th e produce r o f an unregistere d fue l o r fue l additive submit s al l th e tes t dat a an d othe r requisit e informatio n require d fo r registratio nbu t th e informatio n submitte d indicate s tha t th e fue l o r additiv e pose s an unreasonabl e ris k t o th e publi c healt ho r welfar e o r t o a n emissio n contro l system . On e possibilit yi s t o vie w §211(b ) a s implicitl yauthorizing denia l o f registratio n whe n a n unacceptabl e ris k i s shown . Anothe r alternativ e i s t o vie w§211(b ) solel ya s aninformation-gathering provisio n wit h§2ll(c ) governing risk-base d regulatory actions . Unde r thi s approach , th e procedure s an d criteri a o f §2ll(c ) woul d hav e t o b e use d i f th e Agenc ywishe d t o den yregistratio n base d o n natur e o f th e risk s show nb yth e -53

-P.5 5

test s o r informatio n submitte d fo r registration . I f §211(c ) i s th e basi s fo r regulating a risk , mayth e Agenc y den yregistratio n whil e a propose d regulatio nunde r §21l(c ) i s pending whic hwoul d prohibi t o r limi t th e us e o f th e fue l o r additive ?

V . Possibl e Progra mProtocol s

A . Healt hEffect s Th e requirement s an d tes t protocol s i nth e healt h effect s progra

mmus t b e coordinate d an d structure d t o yiel d th e informatio n neede d t o determin e whethe r o r no t th e produc t maycaus e th e healt heffect s o f concern . Thi s include s collectio n o f currentl yavailabl e healt heffect s an d othe r informatio nneede d t o asses s ris k a s wel l a s th e generatio n o f additiona l healt heffect s dat a through testing whe n th e presentl yavailabl e dat a i s insufficient . Th e overal l structur e ca nfollowa matri xo r tiere d forma t o r a combinatio n o f both . Amatri xwoul d b e a se t o f requirement s o f whic hal l woul d nee d t o b e completed . Tier s woul d b e se t up a s sequentia l level s o f requirement s wher e lowe r leve l woul d nee d t o b e complete d prio r t o th e highe r levels . Th e healt heffect s programbein g considere d byEP A
-54

-combine s feature s o f bot ha matri xan d tiere d format . I t woul d b e se t u

p wit hvariou s tiers , an d withi nsome tier s ther e woul d b e a se t o r matri xo f test s and/o r othe r requirement s tha t woul d hav e t o b e completed . Fuels/additive s woul d hav e t o sequentiall ycomplet e on e o r mor e tier s depending o nth e finding s i neac htier . Thi s progra mwoul d b e formulate d suc htha t producer s woul d onl y hav e t o complet e th e tier s neede d t o gathe r th e healt h effect s informatio n require d fo r decisio nmaking , withou t having t o subjec t eac hfuel/additiv e t o a predetermine d ful l arra

yo f test s tha t mayb e unnecessaryan d prohibitivel ycostly . Th e healt heffect s program bein g considere d b

yEPAwoul d consis t o f four tier s an d a matri x o r se t o f requirement s withi n eac htier . I t woul d b e designe d t o b e a s self-implementing a s possible . Eac ho f thes e i s discusse d below .

An explanatio n o f th e firs t tie r require s th e developmen t o f concept s involving "bas e fuels " (withou t direc t additives) , "bas e additives" , an d thei r potentia l healt heffects . First , t o qualif ya s a bas e fuel/additive , ther e woul d hav e t o b e adequat e existing healt heffect s testing informatio n t o determin e potentia l publi c healt h effect s fo r regulatorydecisio nmaking . (EP Aspecificall y request s commen t o n whethe r adequat e healt heffect s testing informatio n currentl yexist s t o qualif yan yparticula r
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fuel/additive a s a "bas e fuel/additive " a t thi s tim e and , i f not , request s specifi c recommendation s a s t o wha t additiona l informatio ni s neede d fo r a candidat e fuel/additive t o qualify . A s note d above , EPAha s include d i n Docke t No . A-90-0 7 a lis t o f man yo f th e publishe d report s o n existing fuels. ) Second , EP Awoul d see k t o develop definitions/specification s fo r bas e fuels/additive s suc htha t an

yfuel/additiv e whic hwoul d mee t th e specificatio n fo r a give n bas e fuel/additiv e woul d hav e essentiall yth e same potentia l publi c healt heffects . Comment s ar e invite d o n th e criteri a t o b e used . Thus , th e firs t tie r woul d involv e th e basi c concep t o f comparing othe r fuel s an

d additive s seeking registratio nunde r §211(b)(2 ) t o th e specification s EPAwoul d develo p fo r bas e fuels/additives . Existing fuel s an d additive s coul d als o see k t o sho wbysuitabl e informatio ntha t the ymee t appropriat e specification s fo r th e bas e fuel/additive . Assuming bas e fuel s additive s ar e identified , th e fuels/additive s whic hconformt o appropriat e specification s o f bas e fuels/additive s woul d no t b e require d t o underg o furthe r healt heffect s testing unles s ne wconcern s aris e i n th e future :

Thus , th e basi c tie r 1 requiremen t woul d involve reporting o f informatio n including physico/chemica l properties , productio nvolume , concentratio n i nuse , an d

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chemica l compositio n an d structur e activit yrelationship , i f needed , fo r eac hfue l o r additive . Producer s who believ e tha t thei r fuels/additive s woul d mee t th e specification s fo r on e o f th e bas e fuels/additive s woul d submi t dat a an

d othe r analysi s calle d fo r i nthe regulation s providing justificatio n fo r thei r view . N o furthe r healt heffect s testing woul d b e require d fo r thos e fuels/additive s foun d t o mee t th e specification s fo r a bas e fuel/additiv e fo r suc htesting woul d b e duplicativ e o f adequat e existing data . Fo r thos e fuels/additive s foun d no t t o fal l withi n th e specification s fo r a bas e fuel/additive , th e presumptio n woul d b e tha t EP Adoe s no t no whav e sufficien t informatio nfo r regulatorydecisio n makin g an

d th e fuel/additiv e woul d hav e t o procee d t o tie r 2 . Th e goa l o f th e tie r 2 requirement s woul d b e th e collectio n an

d submissio n o f existing healt heffect s informatio n fo r th e fuels/additive s i nquestion . I t woul d requir e th e produce r t o conduc t a thoroughliteratur e searc h(publi c an d in-house ) fo r physico/chemica l information , healt heffect s studies , analyses , dat a an d an y othe r relevan t informatio nrelate d t o bot hth e raw fuel/vapor , combustio nproducts , an d possibl yatmospheri c transformatio n product s o f th e fuel/additive . Thi s woul d cove r informatio n o n al l o f th e huma n healt heffect s o f

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-interest , including bu t no t limite d t o carcinogenicity ,

mutagenicity , teratogenicit ya s wel l a s othe r acute , subchroni c an

d chroni c effect s discusse d previousl yi nthi s notice . A s par t o f th e rulemaking EP Awil l nee d t o mor e specificall ydefin e wha t healt heffec t endpoint s mus t b e assesse d beyond thos e specifie d i n §211(b)(2)(A) . A s par t o f thi s tier , a produce r woul d mak e an yreques t fo r a finding unde r §211(e)(3)(C ) tha t additiona l testing o f th e particula r fuel/additiv e woul d b e duplicativ e o f adequat e existing testing .
I f healt heffect s informatio ni s supplie d t o addres s al l o f th e healt heffect s endpoint s identifie d i ntie r 2 , th e fuel/additiv e woul d no t b e require d t o ente r tie r 3 . I f relevan t gap s exis t i nth e healt heffect s informatio n submitted , the n th e fuel/additiv e woul d b e require d t o ente r tie r 3 . I t i s i n tie r 3 wher e producer s woul d b e require d t o conduc t an yneede d short

- o r medium-termhealt h effect s tests . I f th e informatio n fromtier s 2 an d 3 sho w a possibl e healt heffect s concer n an d mor e definitive/extensiv e healt heffect s testing ha s no t bee n conducted , the n th e fuel/additiv e woul d b e require d t o procee d t o tie r 4 . Tie r 3 requirement s woul d involve short

- an d medium-term

healt heffect s testing (i.e. , screening , acut e -58

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an d subchronic) . Depending o n th e natur e o f th e healt h effect s informatio n availabl e fromtie r 2 , th e testing i n tie r 3 coul d b e quit e comprehensiv e o r limite d onl yt o th e gap s unfille d i n tie r 2 . Tie r 3 test s woul d likel yinclud e test s fo r physico/chemica l properties , a nAme s test , othe r geneti c toxicit ytests , screening inhalatio nstudie s a s wel l a s an

yacut e an

d subchroni c studie s neede d t o determin e potentia l publi c healt heffects . EPArequest s commen t o n th e nee d fo r ora l and/o r derma l vs . inhalatio n studies . Healt heffect s covere d includ e pulmonary toxicity , mutagenicity , carcinogenicity , an d teratogenicit y (or toxicologica l indicator s thereof), * an d othe r healt h hazards , i f appropriate . O f course , EP Amus t reserv e th e righ t t o requir e specifi c o r additiona l test s fo r eac h fuel/additiv e o n a case-by-cas e basis . EPAwoul d anticipat e tha t thes e test s coul d b e complete d withi n th e previousl ydiscusse d three-yea r tim e perio d fo r submitting requisit e information . Individua l fuel s an d additive s woul d procee d int o tie r 4 onl yi f th e availabl e tie r 2 informatio n o r tie r 3 tes t result s wer e suggestiv e o f an vuiresolved , ye t potentiall y significant , healt heffect s concern . Conceptually , tie r 4 test s woul d b e follow-u p long-ter

m test s fo r carcinogenicity , mutagenicity , an d teratogenicit y(an d

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othe r endpoints) , an d coul d involv e chroni c inhalatio n and/o r feeding studie s among others . Test s woul d b e structure d t o provid e adequat e toxicologica l informatio n fo r making ris k assessments . Again , raw , combustion , an d possibl yatmospheri c transformatio n product s coul d b e included . EPAinvite s comment s o nth e criteri a tha t shoul d b e include d i n th e guideline s an d th e proces s tha t shoul d b e use d fo r makin g individua l determination s an d developing appropriat e procedures . EPAi s considering adopting man y o f th e test s o f th e TSCAHealt hEffect s Testing Guideline s (4 0 CF R798 ) a s guideline s unde r tier s 3 an d 4 an d ask s fo r commen t i n thi s area . , Thus , tie r 3 an

d 4 testing requirement s woul d appl y primaril yt o fuel s an d additive s fo r whic hther e i s insufficien t informatio n o r wher e th e availabl e informatio n suggest s tha t th e substanc e ma ypos e a n unreasonabl e ris k o f injuryt o huma n health . Fo r example , ther e ar e a numbe r o f curren t aftermarke t fue l additive s fo r whic hther e i s littl e publicl yavailabl e healt heffect s information , an d futur e alternativ e fuel s an d thei r additive s coul d als o b e subjec t t o testing i f adequat e informatio ndoe s no t exis t base d o n tier s 1 an d 2 . Depending upo nth e adequacyo f existing i test s an d th e specification s fo r bas e fuels/additives , thi s approac ht o healt heffect s testing coul d substantiall yreduc e th e numbe r o f fuels/additive s potentiall ysubjec t t o furthe r testing . -60

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Th e four tie r programdescribe d above ha s severa l inheren t advantages . First , i t i s a flexibl e approac h whic hfocuse s o n availabl e informatio n regarding healt h effect s withou t requiring arbitrarytesting . Second , th e tiere d approac hinsure s tha t neede d testing wil l b e accomplished . Third , overal l progra m cos t i s reduce d unde r th e tie r approach . And , finally , th e matri xforma t se t up withi n eac htie r help s scree n fals e negative s an d yiel d mor e confiden t results . Sectio n 211(b)(2)(A ) clearl yindicate s tha t carcinogenicity , mutagenicity , an d teratogenicit yi s t o b e assessed . However , EP Ai s allowe d some judgmen t i n determining wha t othe r healt heffect s endpoint s shoul d b e included . EP Aask s commen t o n wha t othe r healt heffect s endpoint s shoul d b e include d a s mandatory , whic hshoul d b e applie d o n an individua l basis , an d throughwha t procedur e thes e determination s shoul d b e made . Overall , thi s program approac hi s intende d to : 1 ) provid e anefficien t mean s o f identifying an

d summarizing th e existing informatio no n th e healt heffect s o f fuel s an d additives , 2 ) identifying th e informatio n gaps , an d 3 ) generating th e ne winformatio n neede d fo r regulatorydecisio n making .

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B . Effect s o n Emissio n Contro l System s

I n additio n t o a progra mfo r healt heffects , th e Ac t als o require s th e producers/manufacturer s t o provid e th e informatio n tha t i s "reasonabl e an d necessary " t o determin e th e emission s resulting froma fue l o r fue l additiv e an d th e effec t o f suc ha fue l o r fue l additiv e o n th e emissio n contro l performanc e o f an yvehicl e o r engine . Th e potentia l scop e coul d includ e emissio nspeciatio nfo r regulate d an

d unregulate d pollutant s a s wel l a s effect s o n initia l emissio n rates , emissio ndeterioratio nrates , maintenanc e requirements , systemlongevity , an d materials . Othe r concern s coul d includ e overal l genera l effect s o n th e vehicle/engin e an d emissio n contro l system performance . EPAinvite s comment s o nth e exten t t o whic hinformatio ni s neede d o n thes e effects .

EP Ai s contemplating a programdesignsimila r t o tha t discusse d previousl yfo r healt heffect s an d woul d agai n primaril yutiliz e a tiere d approac hwit ha matri xo f requirement s i n some tiers . Th e principle s discusse d earlie r regarding bas e fuels/additive s woul d als o appl y here . EPAdoe s no t anticipat e a needlessl ybroa d testing program , bu t woul d striv e t o limi t an yinformatio n reporting o r testing t o onl ythos e fuels/additive s wher e

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informatio n i s neede d fo r regulatorydecisio n makin g or concern s exis t ove r risk s t o th e emissio n contro l system performance . Th e tier s envisione d fo r determining emissio n contro l systemeffect s ar e discusse d individuall ybelow .
A s wit htie r 1 unde r th e healt heffect s program , thi s initia l tie r woul d involve th e us e o f th e bas e fuels/additive s concep t an d a showing b

yth e producer s tha t thei r fuels/additive s fal l withi nth e specification s o f on e o f th e bas e fuels/additives . Lik e unde r th e healt heffect s program , fo r a fue l o r additiv e t o b e specifie d a s a bas e fuel/additive , adequat e existing informatio nmus t b e availabl e o n th e emissio n contro l systemeffect s o f th e fuel/additiv e fo r regulatorydecisio n making . Assuming bas e fuels/additive s ar e identified , fuels/additive s whic h mee t th e specification s o f a bas e fuel/additiv e woul d b e exemp t fromtesting unles s ne winformatio nneed s arise . Thos e product s whic hd o no t fal l unde r on e o f th e bas e fuels/additive s woul d b e require d t o ente r tie r 2 , sinc e th e presumptio n woul d b e tha t EPAdoe s no t no whav e sufficien t informatio n o n thos e product s fo r regulatory decisio n making .
A s wit hth e healt heffect s program , EPAask s commen t o n whethe r adequat e emissio ncontro l systemeffect s informatio n currentl yexist s t o qualif yan yparticula r -63

-fuel/additiv e a s a "bas e fuel/additive " a t thi s time and ,

i f not , request s recommendation s a s t o wha t additiona l informatio n i s neede d fo r a candidat e fuel/additiv e t o qualify . Tie r 2 woul d requir e th e produce r t o submi t whateve r additiona l informatio ni s presentl yavailabl e o nth e emission s o r emissio n contro l systemimpact s fo r th e fuel/additiv e unde r consideration . . Thi s woul d includ e a literatur e searc hfo r publi c an d in-hous e engineering studies , analyses , an d dat a aime d a t determining whethe r o r no t th e fue l o r additiv e showe d an ypotentia l fo r advers e effect s i n th e area s o f concer ndiscusse d above . I f th e informatio n submitte d wa s sufficien t n o testing woul d b e required . If , however , th e availabl e dat a wa s insufficient , o r th e fue l o r additiv e showe d potentia l fo r causing variou s undesirabl e effect s o n emissions , emissio n contro l system

performance , o r th e vehicle/engin e i n general , the n th e fuel/additiv e woul d hav e t o ente r tie r 3 . Requirement s an

d test s unde r tie r 3 woul d b e focuse d o n assessing specifi c concern s raise d i n tie r 2 , o r jus t o n supplying th e informatio nlacking fromth e tie r 2 requirement . Thi s tie r coul d involve an ycombinatio no r

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for mo f vehicle/engin e test s t o provid e th e neede d information , bu t EPAwoul d expec t i t t o b e complete d withi n th e aforementione d three-yea r time perio d fo r submitting requisit e information .
EPAinvite s commen t o nho wthi s programshoul d b e implemente d an

d wha t testing an d othe r informatio nshoul d b e considere d reasonabl e an d necessary . EPAals o invite s comment s o n wha t specifi c test s ar e appropriat e an d shoul d b e included . C . Determinatio n o f Welfar e Impact s Unde r §211(e) , th e Agenc yi s t o issu e regulation s tha t wil l implemen t it s authorit yregarding th e assessmen t o f welfar e effects . CA Asubsectio n 211(b)(2)(B ) state s tha t th e Administrato r mayrequir e producer s t o furnis h informatio n tha t i s "reasonabl e an d necessary " t o determin e th e exten t t o whic hemission s o f fuel s an d additive s affec t th e publi c healt ho r welfare . Th e welfar e effect s potentiall yinclud e al l aspect s o f ecology . Thi s assessmen t coul d tak e int o consideratio n th e emissions ' residenc e tim e i n th e air , th e fat e o f th e pollutant , an d wha t reaction s occu r wit hothe r pollutant s i n th e air , including atmospheri c transformatio nproducts/byproduct s an d depositio n effects . -65

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Th e Agenc yi s considering using a tiere d approac hlik e tha t discusse d above i n determining welfar e effects . Fuels/additive s t o b e registere d unde r §211(b)(2 ) woul d b e compare d wit hspecification s EPAwoul d develop for "bas e fuels/additives" . Again , EPArequest s commen t on whethe r adequat e reasonabl e an d necessaryinformatio nexist s on welfar e effect s t o qualif yan yparticula r fuel/additive a s a bas e fuel/additiv e a t thi s time and , i f not , request s specifi c recommendation s a s t o wha t additiona l informatio n i s neede d fo r a candidat e fuel/additiv e t o qualify . Producer s woul d b e require d t o submi t informatio n t o show tha t thei r fuel/additiv e meet s th e specification s define d fo r bas e fuels/additives . I f n o fuels/additive s qualifying a s "bas e fuels/additives " ar e determine d o r i f thi s informatio n di d no t showth e fuel/additiv e t o b e essentiall yth e same a s a bas e fuel/additive , the n furthe r reporting requirement s woul d b e necessary . Lik e tie r 2 discusse d earlier , thi s woul d involve a thoroughliteratur e searc hfo r existing informatio nan d dat a o nknow

nwelfar e effects . I n submitting information , producer s coul d b e require d t o repor t th e know n welfar e effect s o f th e raw , combustion , an

d atmospheri c transformatio nproduct s o f fuel s an

d additives . Suc hinformatio ncoul d b e obtaine d fromstudies , literatur e searches , reports , summarie s o f existing dat a an

d information , an

d othe r readil yavailabl e discussio n concerning th e assessmen t o f welfar e effect s

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-associate d wit hth e use/combustio no f fuel s an d fue l additives . Thi s informatio ncoul d the nb e use d t o determin e whethe r o r no t th e produc t pose s a significan t hazar d t o welfar e o r th e environment . I f a potentiall y seriou s welfar e threa t exists , base d o n criteri a establishe d i n thi s rulemaking fo r making suc ha determination , the n furthe r studies , whic hcoul d b e include d a s tie r 3 and/o r 4 , mayb e require d o r appropriat e regulatoryactio n taken . EPArequest s comment s o nthi s approac han

d o n th e exten t t o whic hth e welfar e effect s shoul d b e assesse d throughth e submissio no f informatio no r throughspecifi c testing requirements . ,Th e Agenc ywelcome s suggestion s regarding othe r appropriat e mean s o f assessing welfar e effects . EPAals o ask s commen t o n th e applicabilit yo f th e TSCAEnvironmenta l Effect s Testing Guideline s (4 0 CF RPar t 797 ) t o thi s requirement .

VI . StatutoryAuthorit y Authorit yfo r th e action s propose d i nthi s notic e i s grante d t o EP Aby§21 1 an d §30 1 (a ) o f th e Clea nAi r Ac t a s amende d [4 2 U.S.C . 7521(a) , 7525 , an d 7601(a) ; Pub.L . 95-95] .

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-VII . Administrativ e Designatio n an d RegulatoryAnalysi s Executiv e Orde r 1229 1 state s tha t an Agencymus t judg e i f a rulemaking woul d b e "major" . Arulemaking i s considere d "major " i f i t wil l hav e anannua l effec t o nth e econom yo f $10 0 millio n o r more , i f ther e wil l b e a majo r cos t increas e fo r consumers , individua l industries , federal , state , or loca l governmen t agencies , o r othe r geographi c regions , an d i f ther e wil l b e significan t advers e effect s o n competition , employment , investment , productivity , innovation , o r o nth e abilit yo f U.S.-base d enterprise s t o compet e wit hforeign-base d enterprise s i n domesti c o r expor t markets . A t thi s juncture , i t ha s no t bee n determine d i f thi s actio nrepresent s a majo r rulemaking .
VIII . Publi c Participatio n

T o ai d i n preparing th e propose d rule , EPAencourage s ful l publi c participatio ni n thi s action . Comment s ar e requeste d o n al l aspect s o f th e suggeste d programan d from al l intereste d parties . I f possible , comment s shoul d b e accompanie d byful l supporting dat a (including productio n volum e dat a an

d complet e chemica l compositio ndata ) an d a detaile d analysis . Partie s ar e encourage d t o submi t informatio n whic hma yno t b e detaile d i nth e curren t
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registratio n databas e a s EPAwil l b e using wha t informatio n i s presen t i n supporting analyse s fo r th e NPRM . Du e t o th e time elapsed , EPAi s no t considering comment s submitte d t o Docke t ORD-78-0 1 fo r th e 197 8 ANPRMunles s the yar e resubmitte d t o Docke t A-90-0 7 fo r thi s curren t rulemaking . Comment s containing proprietaryinformatio nshoul d b e sen t t o th e contac t perso nliste d above ; however , a non-confidentia l versio nshoul d b e sen t t o th e publi c docke t i f th e informatio ni s intende d t o b e considere d b y EPAi n developmen t o f th e NPRM . Informatio ncovere d b ya clai mo f confidentialit ywil l b e disclose d byEPAonl yt o th e exten t allowe d an d b yth e procedure s se t fort hi n4 0 CF RPar t 2 . I f n o clai mo f confidentialit yaccompanie s th e submissio n whe n i t i s receive d b yEPA , i t mayb e mad e availabl e t o th e publi c withou t furthe r notic e t o th e commenter .

EP Adesire s specifi c comment s o nth e following additiona l issue s regarding thi s rule : l . Healt hEffect s

a . Shoul d EP Adevelo p tes t guideline s or , mor e specifically , tes t plan s fo r purpose s o f determining healt h effects ?

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b . i n th e even t tha t EPAestablishe s mor e tha n on e testing plan , shoul d th e tes t pla n selecte d receiv e prio r EPAapproval ? c . Ho wshoul d th e tes t pla n b e organized , tie r o r matrix ? d . Fo r th e four tier s suggeste d i nthi s notice , wha t shoul d th e requirement s be ? e . Wha t othe r healt heffects , beside s carcinogenicity , mutagenicity , an d teratogenicity , shoul d b e considered ? f . Wha t test s shoul d b e required ? g . Wha t constitute s anacceptabl e test ? h . Wha t shoul d b e th e criteri a fo r determining positiv e an

d negativ e tes t results ? i . Ho wshoul d th e pollutant s b e administere d t o th e hos t bein g teste d (rout e o f exposure) ? j . Wha t i s th e mos t appropriat e grouping scheme fo r fuel s an

d additive s an

d wha t criteri a shoul d b e use d t o designat e fuel s an

d additive s int o prope r categories ? k . Ho wshoul d representativ e fuel s o r additive s fro mwithi n eac hgrou

p b e selected ? 1 . Wha t criteri a shoul d b e use d t o excus e a fue l o r additiv e fromadditiona l testing base d o navailabl e information ? m . Ho wshoul d fue l an d additiv e manufacturer s submi t tes t data ?
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-n . O n wha t basi s o r leve l o f ris k shoul d a contro l

b e establishe d fo r a fue l o r additive ? o . Ho wcoul d existing guideline s (TSCA , FIFRA , OECD , EPA ) b e applie d i nthi s rulemaking ?
2 . Emission s Effect s Testing

a . Shoul d EPAdevelop tes t guideline s or , mor e specifically , specif ytes t plan s fo r purpose s o f determining emissio n contro l systemeffects ? b . I n th e even t tha t EPAestablishe s mor e tha non e testing plan , shoul d th e tes t pla nselecte d fo r us e b yth e produce r receiv e prio r EP Aapproval ? c . Ho wshoul d a progra mb e structure d fo r assessing th e effect s o f a fue l o r additiv e o n emissio ncontro l systemperformance ? d . Wha t test s shoul d b e included ? e . Wha t constitute s anacceptabl e test ? f . Wha t criteri a shoul d b e use d t o decid e i f th e tes t i s positiv e o r negative ? h . Ar e ther e an yexisting tes t plan s o r procedure s fo r assessing th e performanc e o f emissio ncontro l system s tha t shoul d b e use d i nthi s program ? i . Wha t procedure s shoul d b e use d fo r sampling unregulate d emissions ?

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-j . Wha t portio n o f th e exhaus t shoul d b e collecte d

an d measure d (i.e. , whol e exhaust , fractionate d exhaust , irradiate d whol e o r fractionate d samples) ? k . Wha t driving cycle s shoul d b e par t o f a testing program ? 1 . Ho wman

ymile s shoul d an engine/vehicl e b e drive n fo r eac htie r o f testing ? m . Shoul d evaporativ e an d refueling emission s be , sampled ? n . Shoul d running losse s b e sampled ? o . Ho wshoul d manufacturer s submi t tes t data ? p . O n wha t basi s shal l fuels * an d additive s b e controlle d o r banned ? 3 . Othe r Matter s

a . Wha t welfar e effect s shoul d b e assesse d an d ho w shoul d thi s b e accomplished ? b . Beside s grouping fuel s an d additive s tha t ar e essentiall yth e same , wha t othe r mean s ar e ther e fo r minimizing duplicativ e testing ?

c . Wha t measure s shoul d b e implemente d t o allowfo r cost - and/o r burden-sharing betwee nmanufacturers ?

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d . Wha t criteri a shoul d b e use d t o determin e i f a fue l o r additiv e manufacture r i s a smal l business ?

e . I f volume an d sale s level s ar e use d t o defin e smal l business , wha t level s shoul d thes e b e se t at ?
f . Shoul d a manufacture r b e excuse d fro m healt h effect s an

d emissio n testing wher e i t ca ndemonstrat e tha t th e fue l o r fue l additiv e i n questio n wil l no t caus e an advers e healt heffec t o r affec t emissio n contro l devic e performance ? I f so , wha t shoul d EP Arequir e from th e manufacture r t o mak e suc ha showing ? Shoul d EPAdevelo p » screening tes t requirement s a s par t o f thi s rulemaking a s outline d earlier ? g . Wha t factor s shoul d b e include d i nan y enforcemen t program ?

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### IU:HN N HKbU K' ' " ' PUG-02-'9 0TH

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### Lis t 0% Subject s i n4 0 CF RPar t 7 9 Fuel , Fue l Additives , Gasoline / Gasolin e Additives , Diesel / Diese l Additives / Healt han dwelfar e Effects , Emissio n Contro l Systems / Moto r Vehicl e Pollution , Penalties , Administrativ e Practice s an dProcedures . Dated : 

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