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. Augus t 7 , 199 0

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# Environmenta l Protectio n Agenc y
4 0 CF RPart7 9 Fuel s an d Fue l Additive s Registration ; Advanc e Notic e o f Propose d Rulemakin gP. 3

3221 8 Federa l Registe r / Vol . 55 , No . 15 2 /

Tuesday , Augus t7.199 0 / Propose d Rule s
ENVIRONMENTA L PROTECTIO N AGENC Y 4 0 CF R Part 7 9 (FRL-3811-2 1 RI N 2060-AC1 0 Fuel s an d Fue

l Additive s Registratio n AGENCY : Environmenta

l Protection Agency (EPA)
. ACTION : Advanc e notic e o

f propose d rulemakin g (ANPRM)
. SUMMARY : Thi s actio n announce s EPA' s intentt o develo p regulation s an

d establis h progra

m protocol s and tes t procedures relate d t

o th e testin g o

f motor vehicl e fuel s and fue l additive s fo r purposes of

registratio n a s prescribe d i n sectio n 21 1 (b ) and (e ) o f th e Clea n Air Ac tThe regulations ar e t o provid e fo r test s t o determine potentia

l pubU c healt h effects and such othe

r informatio

n a s i s reasonabl e an

d necessary t

o determine emissio n contro l syste m effect

s and welfar e impacts
. Th e regulations wil l appl y t

o curren tan d futur e fuel s an d fue

l additive s require

d t o b e registered under sectio n 211
. B y law , th e regulation s ma

y als o incorporat

e smal l busines s and cos t sharing provision s an d provision s t o guar d agains tduplicativ e testing
. DATES : EP A wil l conducta hearin

g o n thi s Advanc e Notic e of

Propose d Rulemakin

g (ANPRM

) o n September 26 , 199 0 I n Ann Arbor

, Michigan
. Th

e hearing wil l conven e a t9 a.m. an d wil l adjour

n atsuch time a s i s necessary t o complet

e the testimony
. Writte

n comment s o n thi s ANPR

M wil l b e accepte d fo

r 3 0 day s followin g the hearing
. ADDRESSES

: Th e hearin g wil l b e hel d a t Domino' s Farm

s i n An n Arbor

, Michiga n (313-930-5032)
. Domino' s Farm s i s locate d o n Earhar

tRoad juston e quarte

r mil e eas tof

Plymout h Roa d a tUS-23
. Comment s o n th e ANPR

M shoul d b e submitted in duplicate to : EP A Ai r Docket(LE-131) ; Attention : Docke tNo . A-90-07 ; U.S
. Environmenta l Protectio n Agency , Roo

m M-1500,401 M Street SW. , Washington , D C 20460, (202 ) 382
- 7548
. Thi s docke ti s locate d atth e abov e addres s o n the firstfloo r o f Watersid e Mal l and i s ope n for publi c inspectio n weekday s from 8:3

0 a.m . t o 1 2 noon an

d fro m 1:3 0 p.m. t o 3:3 0 p-m . A s provide

d i n 4 0 CF Rpar t2 , a reasonabl e fe e ma

y b e charged b y EP

A for copyin g services
. FO RFURTHE RINFORMATIO N CONTACT : Mrs . Caroly

n Krueger , Emission Contro

l Technolog

y Division , U.S
. Environmenta

l Protectio n Agency , 256

5 Plymout h Road , Ann Arbor
. M

I 48105, (313) 668-4274
. SUPPLEMENTAR Y INFORMATION : I. Public Hearin

g An y perso n intereste d i n presentin g testimon y atth e publi c hearin g shoul d notif y th e contactperso n liste d abov e o f suc h inten ta tleas tseve n day s prior t

o the da y o f the hearing
. Th e contac t person shoul d als o b e provide d a n estimat e o f the tim e require d fo r the presentatio n o

f the testimony and notification of

an y nee d fo r audio/visua l equipment

. A sign-u p shee twil l b e availabl e atth e registration tabl e the mornin g o f di e hearing fo

r schedulin g th e orde r o f testimony
. I

ti s suggeste d tha tsufficien tcopie s o f the statemen to

r materia l t o b e presente d b e brough tt o th e hearin g fo r distribution t

o the audience
. Mr . Richar d D . Wilson , Director , Offic e o f Mobil e Sources , Office o f Air and Radiation , ha s bee n designate d a s the presiding officer o

f th e hearing
. The hearin g wil l b e conducte d informally , an d technica

l rule s o f evidenc e wil l not apply . Writte

n transcript

s of th e hearing wil l b e made . Anyon e desirin g t o purchase a cop y o

f th e transcrip tshoul d mak e individua

l arrangement

s wid i di e cour treporte r recording th e proceedings
. n . Introductio

n EP A i s announcing its plan s t o implemen tit s statutor

y authorit y t Q asses s th e effects o

f motor vehicl e fuel s an d fue l additive s o n th e pubh c health , welfare , an d emissio n contro l systems . The progra

m bein g develope d i s expecte d t o b e a

n importan

tmean s o f gatherin g information aboutth e healt h an d welfare effects of

fuel s and fue

l additives
. Base d o n the tes tdat a an d othe r information obtained , EP A wil l b e abl e t o evaluate wheme r any limit s ar e neede d o n fuel s and additive s unde r the statutor y criteri a i n sectio n 211(c)
. EP A ha s recend y starte d th e developmento

f th e propose d rule s an

d welcome s publi c inpu

tregardin g the bes twa y t

o structur e th e progra

m t o achiev e th e Congressiona l goals . EP

A i s intereste d i n way s t

o mak e th e progra

m manageable , minimize undue burdens , an d a tth e sam e time ensure tha ta n adequat e leve l of testin g i s done.-Thi s ANPR M wil l discus s issue s an d option s involve d i n determining potential pubhc health , welfare , and emissio n control system effect s of

fuel s and fue

l additives
. This Advanc e Notic e i s organized t o highligh ttopic area s an d issue s diatar e importan tfor progra

m developmen tI

n some cases , EP

A ha s identifie d it s tentative plan s a s a basi s fo r invitin g commentI

n othe r areas , wher e th e preliminar

y plan s ar

e les s developed , th e notic e raise s question s an d solicit s informatio n fro m commenters . EP

A ha s identified a numbe

r o f topic s and question s in thi s notic e upon which it particularl

y seek s comments . Comment s and suggestion s hor

n di e public , di e affected industry , environmenta l interests , and the scientifi c communit y ar e especiall y sought. Th e remainde

r o f thi s notic e i s divided int

o the followin g general areas . Following thi s introductor y section , a summar y o f the statutor

y authorit y in thi s are a i s give n togethe r wit

h a chronolog y of pas taction s and recent developments . Thi s i s followe d b y a fairl y broa d discussio n of

th e desig n and implementation issue s relate d t o th e fue l and fue l additiv e testin g program . Base d o n thi s discussio n and analysis , th e nex t sectio n describe s i n genera l terms a possibl e progra

m approac

h fo r health , emissio n control system , an d welfar e testin g an d assessments . Th e ANPR M close s widi a

n invitatio n for publi c participation and a detaile d lis to f question s and issue s o n whic h EP A desire s commen t HI . Statutor y Background and Provision s Sectio n 211(a

) o f th e Clean Ai r Ac t (CAA) , 4 2 U.S. C 7545
. give s th e Administrator th e authorit y t o require th e registration of

fuel s an d fuel additive s prior t

o sal e o r introductio n int o commerce . EP

A issue d suc h regulations i n 197

5 (40 CF Rpar t79)
. I n 1970, EP

A wa s give n authorit

y (Pubh c La w 91-604
. Decembe r 31,1970 ) t o requir e certai n test s and othe r informatio n befor e registratio n of

fuel s and additives
. Mor

e specifically , sectio n 211(b)(2 ) provide d tha

tEP A "ma y als o require " the manufacturer "t o conduct test s t o determine potential healt h effects " (including carcinogenicity , teratogenicity , and mutagenicity ) of fuel s an d fue l additive s and t

o requir e other "reasonabl e an d necessary " informatio n t o identif

y emission s an d their effect(s ) o n th e emissio n contro l system performanc

e o f vehicle s o

r vehicl e engine s and th e publi c healt h o r welfare
. Test s fo

r healt h effect s ar

e t o b e conducted accordin g t o procedure s and protocol s establishe d b y th e Administrator and any result s wil l no t b e considere d confidential
. Also , sectio n 211(b)(3) state s tha

tth e Administrato r shal l gran tregistratio n i

f th e abov e provision s ar

e satisfie d includin g assurance s tha

tthe Agenc y wil l receiv e any futur e change s i n th e informatio n required
. Almoug h di e genera

l registratio n regulations wer e implemente d i n 1975 , EP A did notimplementth e discretionary authorit y t o requir e health , welfare , an d emissio n control syste m effect s testin gP. 4

a : ©M B 

### / Vo L .55 , No

. 15 2 /

Tuesday , Augus t

7, 1S3 0 / Propose d Rule s



# f l

v ••JS unde

r sectio n 211(b)(2) o

r establis h procedure s an d protocol s for thes e tests . I n th e CAA Amendment

s of 1977, Congres s adde d a requiremen tt o sectio n 21 1 (Publi c La

w 95-95 , Augus

t7 , 1977)
. Thi s requirement, codifie d a t sectio n 211(e) , mandate s tha tthe Administrato r implementth e sectio n 211(b)(2) authorit

y and provide s additional discretio n concerning th e implementatio n of

th e sectio n 211(b)(2

) testin g requirements
. Sectio n 211(e)(1 ) requires implementatio n o f

th e sectio n 211(b)(2

) authorit y withi n on e yea r of

enactmen t o f the amendments . Sectio n 211(e)(2 ) als o establishe s time limit s b y whic h producer s mus tcompl y wit

h the regulations
. Fo

r thos e fuel s and additive s no tregistere d a tthe time the sectio n 211(b)(2 ) regulation s ar e promulgated , th e "requisit e information " mustb e submitte d prior t o registration
. Fo r fuel s an d additive s registered a tthe time of promulgatio n th e informatio n mus tb e provide d "n

o late r tha

n thre e years " after promulgation o f the sectio n 211(b)(2) regulations
. Sectio n 211(e)(3) allow s th e Administrato r f o exemp to

r mak e specia l exception s fo

r any smal

l business , f

o provid e for cos tand/o r burde n sharin g with respec tt

o an y fue l o r additiv e manufactured b y tw o o r mor e entities , an d f

o exemp tan

y person fro m such regulation s where additiona l testin g woul d b e duplicativ e o f adequat e existin g testing
. I n a n effor tt o fulfil l the sectio n 211(e)(1 ) requirementtha tregulations b e promulgated withi n on e year , EP A pubhshe d a n ANPR

M i n 197 8 (se e 4 3 F R 38607, Augus t29,1978 ; DocketORD-78
- 01) ; however , neithe r a propose d no r final rule wa s issued
. Nevertheless , i t ha s alway s bee n EPA' s intentio n t o develo p th e required regulations
. Thi s actio n ha s remaine d o n th e EP A regulator y agend a an d a developmen t plan fo r th e rulemaking wa s created i n 1988
. Eve n thoug

h th e sectio n 211(b ) testin g requirement

s wer e no timplemented whe n required , there hav e bee n othe r effort s relate d f

o fuel s and additive s ove r th e pas tte n years . The fue l an d fue l additive s registratio n progra m i s currendy operative
. Sectio n 211(f ) and th e EP A interpretiv e rule o n "substantiall y similar " fuel s (4 6 F R 38582-38586 ; Jul

y 28.1981 ) hav e serve d f o control th e marke

tentr y plac e o f fuel s and direc tadditive s absen ta waive r unde r sectio n 211(f)(4)
. Also , EPA' s Draf tAlternativ e Fuel s Researc h Strateg y provide s broad directio n concernin g th e research neede d f o asses s th e potentia l relativ e public healt h an d welfar e risk s o

f various fue

l formations in production , transport , storage , and vehicl e use . A cop y of thi s "Draf tStrategy " i s availabl e i n the publi c docket ; inquiries shoul d b e directe d to EPA' s Offic

e o f Researc h and Developmen tI

n addition , th e literatur e reflects th e result

s o f a numbe r of program s conducte d t

o evaluate advers e effects o

f fuel s and additives
. A lis tof man y of the report

s publishe d in thi s area ca n b e foun

d in Docke

tNo . A
80-07
. Thus , whil e th e require d sectio n 21 1 progra

m wil l provid e valuabl e additiona l information fo

r assessin g risk, ther e hav e alread y bee n som e activitie s tha

trelate to fuel s and additives
. Some recen tdevelopment s hav e renewe d EPA' s commitmen tto issu e the regulation s a s calle d fo

r b y the statute . Firs ta Jul

y 19,198 9 citizen s petitio n unde r sectio n 21 1 of

the Toxi c Substance s Contro

l Ac t(TSCA) , 1 5 U.S. C 2820 , requeste d the Agency to initiat e a rulemakin

g unde r sectio n 4 o

f TSC A t o requir

e testin g o

f methanol fuel s b y thei r manufacturer s and/o r processors . A n Octobe r 17,198 9 lette r fro m EP A Assistan tAdministrato r Lind a J . Fishe r announce d tha

tEP A woul d initiate a proceedin g unde r the joint authorit y of sectio n 21 1 o

f di e CA A and sectio n < 3 of TSC A to conside r healt

h and environmenta

l effect s testin g o

f al l motor vehicl e fuel s including fuel s currend y i n us e an d thos e undergoin g developmen t Second , a citizen s grou

p brough ta lawsui tchallengin g EPA' s failur e to promulgat

e regulation s withi n the one yea r perio d provide d fo

r i n CA A sectio n 211(e)
. Thomas v . aHeilly, CA
. No . 89
- 626 9 (D
. Oreg
. 1989)
. EP

A ha s entered int o a ConsentDecre e i n setdemen f o f thi s lawsui twithou tth e adjudicatio n of an y issu e of

fac to r law , and th e Decre e ha s bee n signe d b y th e CourtUnder the Decree , th e EP

A Administrato r i s f

o sig n a Notic e of

Propose d Rulemakin

g fo r publicatio n i n th e Federa

l legists ? by Januar y 1.1992 , an d to sig n a Fina l Rul e b y Jun e 1,1993
. B y it s terms , th e Consent Decre e "is no taddresse d t o th e substanc e o

f th e rulemaking " and nothing i n i

f i s f o b e construed "t

o limit o r modif y th e discretio n accorde d ° ° ° b y sectio n 21 1 '"o r genera l principle s o f administrativ e la w i n any fashion"
. IV . Fue l and Fue l Additiv e Progra

m Desig n and Hmplementatioin i Issue s A. Introduction Th e CA A requirement

s clearl y indicate diatdi e fue

l and fue l additiv e progra m provide d fo

r i n sectio n 21 1 i s potentiall y vas ti n scop e and raise s difficul timplementatio n issues
. Thi s notic e presents th e factors tha twil l influence progra m desig n and discusse s ho w th e requirement

s o f th e Ac tca n bes tb e implemented i n lighto f statutor y and practica

l constraints
. The statutor

y provision s governing th e fue l and fue l additiv e progra

m were discusse d above . I

n summary , sectio n 211(b)(2)(A ) require s testin g t o determine potential publi c healt h effects o f the fuel s and fue

l additive s themselves . I

n addition , sectio n 211(b)(2)(B ) provide s authorit y fo r obtaining reasonabl e an d necessar y information relate d t o th e emission s resulting fro

m a fue l o r fue l additive , and th e effecto

f such emission s o n th e performanc

e o f th e emissio n control system , and a

n assessmen to

f the effect o f suc h emission s o n th e pubhc healt h and welfare
. Furthermore, sectio n 211(e)(2) requires th e "requisit e information " fo

r registratio n to b e supplied t o EP A withi n certai n tim

e limit s and sectio n 211(e)(3 ) include s provision s which clearl y indicat e tha t cost-sharin g i s t

o b e take n int

o consideratio n in developin g suc h a program . The legislativ e histor

y als o indicate s tha

tcost s shoul d b e considere d i n promulgating tes t requirement

s and thatth e regulation s ar e no tto b e "undul

y burdensome. " H.R

. Rep tNo . 95-294,95th Cong
. 1s tSess
. 308-0 9 (1977)
. A tth e sam e time, ther

e ar e a numbe r of practica l factor s whic h affec

tho w thes e requirement

s ca n b e implemented
. Firs tther e ar e ove r 6000 active
registere d fuel s an d fuel additive s which coul d potentiall y b e subjec tto healt h effect s test s an d th e othe r requirement s discusse d above . Thi s i s mor e tha n twic e th e numbe

r registere d whe n th e sectio n 211(e)(1 ) requiremen twa s establishe d and , a s discusse d below , thes e ar e expecte d f

o gro w in numbe

r i n the future
. T o requir

e al l o f th e approximately 8000 fuel s and additive s to underg o extensiv e individua

l testin g concurrentl

y woul d plac e onerou s administrative burden s o n th e program , woul d als o b e very resource-intensiv e and coul d easil y excee d the capacit y t o conduc tsuch tests . Moreover, testin g of each fue l and additiv e i s notneede d i f they presentessentiall y th e sam e risks of pubhc healt

h an d welfar e and emissio n control impacts
. Second , fuels/additive s consis tof variabl e complex mixtures
. Dealin g wit h mixtures and thei r emission s present difficultie s in determinin g wha tt o tes t (i.e., whol e mixtures , fractionate d components , transformation products , etc. ) and ho w t o tes ti tWhil e som e detaile d tes tprocedure s d o exis tfo r som e exposure routes , healt h effec ten d points , etc. , some , a s fo

r atmospheri cP. 5

3222 0 Federa l Registe r / Vol

. 55

. No

. 15 2 /

Tuesday

. Augus t

7.199 0 / Propose d Rule s
transformatio n products , ma y b e undeveloped

. Th e stat e o f knowledg e regardin g tes t

procedure s wil l significantl y influenc e th e abilit y o f EP A t o prescrib e th e appropriat e testin g procedures

. Furthermore , test s suc h a s lon g ter mcance r bioassay s ordinaril y requir e mor

e time tha n th e three-yea r perio d specifie d fo

r submissio n o

f requisit e informatio n for

fuel s an d additive s registered a t

th e time th e rul e i s promulgated

. In som e cases , especiall y i n chroni c testing , i t may no t b e possibl e to obtai n accurat e an d conclusiv e results witiii n th e prescribe d tim e specifie d b y th e Act

. Third , health , welfare , an d emissio n contro l syste mimpac t

testin g i s costi y t o administe r

an d conduc t

o n acase-by

cas e basi s and , give n th e potentia l numbe r o f fuel s an d additive s an dtype s o f test s whic h ma y nee d to b e conducted , th e overal l cost s of a n exhaustive programwoul d b e burdensome

. Fourth , complicatin g thi s furthe r i s th e fac t the t a t presen t Gfcesr e ar e onl y a relativel y limite d nnambe

r o f tss t laboratorie s capabl e of

f ©tradircctin

g suc h testin g an d ©the ? erahaltaas , an d fue l an d feel QddittwE

s wos& CTO^M no t

b e the ©nl y Hyp e of testta g tossing handle d a t thes e ffatibiiec. I n add-Mcsa , testin g fo

r atmospheri c transformatio n product s an d dfaei r impac t c mai r qualit y an d health <pftw*

n ma y precaa S a n eve n greate r difficult y in thi s area
. Th e statatar y mparega-anto an d practica l ctrasteaiat o psresesa t wha t may appea r to b s aconflic t

betwee n th e goal s an d Sh

e mean s of

achievin g them

. Th e statut e call s fo

r health , welfare , an d emissk meyete mimpac t

testin g t o b e don e an d provide s aspecifie d tim e fram e fo ? submittin g informatio n wid i du e consideratio n to b s give n to cos t an d undu e burdens

. A revie w o f di e practica l Sector s suggest s tha t thi s coul d b e difScaal t sinc e th e fuel an d fuel additiv e popuatio n i s large , test s ar e tim e mnirnainiiing

, costi y an d sometime s mccodusihre , an d laboratorie s an d othe r facilitie s capabl e of

doin g th e testin g ar e limite d i s mumber

. Th e otatutory mandat e an d it s legislativ e histos y garmd e fo r oome measure s tha t

hel p alleviat e th e burden

. A s discusse d above , th e otatut e contain s provision s for

cost-charin g an d non
duplicatiw e testing , a s wel l a s asmal l busines s exemption

. Pursuan t to th e applicabl e legislativ e history , cost s an d th e preventio n of

undu e burden s ar e t o take n int o accoun t

i n developin g th e tes t requirements. Moreover , "relativel y inexpensiv e bu t

reliabl e tes t

methods " ar e to b e rased "insofa

r a s possible. " H.R

. Rep t 65-294.85t

h Cong

. 1s t

Sess

. 309 (1977)

. Th e statut e als o relie s o n EPA' s judgment'i n establishin g th e tes t program
. Wit

h respec t t o th e tirning of dat asubmission , EP

A ha s discusse d belo w anumbe r

o f option s whic h coul d provid e additiona l tim

e fo r testin g whe n more tim e i s needed

. I n exercisin g it s regulator

y judgmen t i t i s EPA' s inten t

t o develo p aworkable , useful progra

mwhic h satisfie s th e goal s o f th e Act , allow s fo

r th e adequat e assessmen t

of potential health , welfare , an d emissio n contro l syste m performanc e impact s a s required , bu t doe s no t introduc e an infeasibl e o r needles s testin g burde n o n th e producer s o

f th e fuel s an dadditives

. Determinin g representativ e fuel s an d additive s t o test , th e test s to whic h the y shoul d b e subjected , an dth e criteri at o b e use d fo

r suc h determination , wil l b e a n importan t

par t o f thi s rulemaking

.

, Th e programdesig n need s to focu s o n th e potentia l effectivenes s o f agive n regulatory requiremen t

i n meetin g th e goal s o f th e Ac t an dwhethe r

th e result s of suc h requirement s wil l provid e usefu l informatio n fo r

decisio n making

. Th e fue l an d fuel additiv e testin g programwil l represent a Congressionally-mandate d risk assessmen t

for potential advers e effect s o n human health , welfare , an d emissio n contro l syste mperformance

. Sinc e ris k i s afunctio n of

exposur e an dtoxicity (o r effect) , on e ke y tene t

o f th e progra mwil l b e t o asses s potentia l risk usin g thes e factors

. Consideratio n wil l b e give n t o productio n volum e an d know n ' toxicological o r

othe r propertie s i n determinin g th e amoun t

o f testin g needed

. Furthermore , i t

wil l b e importan t t o mak e appropriat e us e o f th e sectio n 211(e)(3 ) provision s to reduc e cost s an d eliminat e replicat e o r unnecessar y testing

. Previou s testing , th e know n similarit y of

man y fuel s an d additives , an d th e curren t stat e o f knowledg e o f

th e risks associate d wid i presen t fuel s an dadditive s mus t

b e take n int o accoun t Th e remainde r

of thi s sectio n of

th e notic e discusse s come o

f th e ke y programdesig n an d implementatio n issue s i n more detail

. Thi s include s more detaile d discussioas , analyses , an d request s fo

r commen t o aboi h th s statutor y requirement s an d th e practica l desig n factor s mentione dabove

. B. Designation of

Fuels and

Fuel Additives Under th e curren t

fue l an dfue l additiv e registratio n regulations , moto r vehicl e gasolines , diese l fuel s an d thei r additive aar e th e onl y designate d fuel s an d additives fo

r purpose s o

f registratio n (Se e 4 0 CH

. par t 79)

. Ther e ar e currend y approximatel y 224 0 active

registere d fuel s an d37S 0 active

registere d fue l additive s whic h mean s that , dependin g o n progra mdesign , a significant amoun t o f testin g coul d b e required

. Recen t

development s i n th e are ao f alternativ e fuel s sugges t

tha t suc h fuel s an d thei r

additive s shoul d als o b e covere db y th e regulation s coverin g gasolin e an ddiese l fuels

. Give n di e potentia l fo

r amajo r expansio n o

f thes e fuel s int o th e marketplac e i n th e future

. EP A i s no w considerin g issuanc e o

f aproposa l whic h woul d designat e severa l additiona l moto r

vehicl e fuel s an d hei r additives fo

r registration

. (5 5 F

R16876 , Apri l 23.1990 ) Thi s coul d include : methanol , ethanol , o r

an y othe r

moto r vehicl e alcoho l fuel' , liquifie d petroleu mgas , an d compresse d natura l gas
. Thes e change s woul dexpan d Ui e type s o f fuel s an dadditive s requirin g registration

. Give n th e larg e numbe r

of individua l fuel s an dadditive s involved

. EP A i s considerin g measure s to reduc e th e cost/testin g burde n whil e a t th e sam e time stil l meetin g th e requirement s o f th e programa s calle d fo

r i n th e Ac t Authority fo

r thes e provision s i s foun d i n sectio n 211(e)(3 ) o

f th e Ac t Sectio n 211(e)(3)(A) provide s fo r

specia l requirement s fo

r smal l business

. Sectio n 211(e)(3)(B ) provide s fo r cost / burde n sharin g fo

r afuel/additiv e produce db y mor e ma n on e person
. Finally , sectio n 211(e)(3)(C ) remove s th e nee dfo r additiona l testin g whe n previou s testin g i s adequat e to mee t th e requirements

. Discussion s an d som e possibl e concept s i n eac h o f thes e thre e area s i s provide dbelow

. I n addition

. EP

A recognize s th e importanc e o

f avoidin g tes t requirement s whic h lea dt o th e unnecessar y us e of

animals

. Eac h of

th e concept s belo w woul dcontribut e t o thi s objective

. Furthermore , late r i n thi s notic e th e Agenc y request s commen t o n othe r approaches , suc h a s tiered requirements , th e us e of

non-anima l tes t system s wher e appropriate , an d di e us e o f structure/activit y an dphysica l chemical dat awhic h woul dals o limi t testin g requirement s an dunnecessar y anima l use
. C. Provisions to Prevent

Undue Burdens 1

. Smal l Busines s Provision s In orde r t o preven t

th e testin g requirements fro

mbein g undul y burdensome , th e CAA give s th e Administrato r

authorit y f

o exemp t o r

' Alcoho l fue l woul d likely b e defined a

a a motor vehicl e fue

l containing otleas tS

O percen talcoho l b y volume . Mixture

s d alcoStol o cax d fjoooliits o tvcml d likely ks registered o

a a gaoolin s i

f th s alcohol conten twa s les s tha

n S O percen tP. 6



### F(s<fl®ra l Iftaglistei r / Vo L 55 , No

. 15 2 /

Tuesday , Augus t

7, 1SS0 / Propose d Rule s provid e deferral s or modification s fo r smal l businesses ; however , "smal l business " mus tb e define d i n the regulations
. EP

A i s considerin g a definitio n includin g sales/revenu e alon e o r i n combinatio n wit

h a n annua l productio n volum e fo

r a give n fuel

/ additiv e a s par

to f thi s definition
. I

n addition , th e toxicity o

r potential risk o

f th e fuel o r fuel additiv e ma y b e take n inf o consideration
. Whil e sales/revenu e may b e mor

e appropriat

e f o ge ta tthe abilit y to pa y aspec to

f a smal l busines s provision , annua

l production volume , togethe r with th e toxicity of th e material , i s very importan twhe n i t come s f o assessin g th e potential risks t o th e pubh c health , welfare , and emissio n contro l syste m performance
. EP A request s commento n whatsales / revenu e tiiresholds ar

e appropriat

e fo r differentfuel s an d additive s an d wha t othe r financial criteri a o

r othe r parameters shoul d b e considered
. EP A als o request s commen

to n ho w the requirement

s for smal l businesse s shoul d b e differentfro

m thos e tha

t appl y i n genera l Th e September 30,198 8 Use r Fe e Rule unde r TSC A sectio n 2

6 (4 0 C M 700.40) define d a smal l busines s concer n a s an y perso n whos e total annual sale s i n th e fiscal yea r preceding th e date of

submissio n o

f th e applicabl e sectio n 5 notice , whe n combine d wit h thos e of th e parentcompan

y (i f any) , ar e les s tha n $4 0 million
. A simila r definitio n i s use d for TSC A sectio n 8 reportin g rule s (4 0 CF

R704.3)
. EP

A request s commento n the applicabilit y of thes e definition s f

o th e fuel s and fue

l additive s program . Producer s o f fuel s and fue

l additive s are strongl y encourage d to b e certain thatth e annua

l production volume s they hav e reporte d to EP

A unde r the fue l and fuel additiv e registratio n progra m ar e accurate an d curren tThi s informatio n i s essentia l if

EP A i s f o develo p workabl e provision s fo

r smal l businesses
. Inaccurat

e o r incomplet

e informatio n coul d resul ti n les s tha n optimu m provision s and the possibilit y tha tfuels/additive s o

r individua

l producers thereof

woul d b e precluded fro m smal l busines s provision s sinc e information wa s lackin g t o demonstrat

e tha tthey shoul d hav e bee n included
. 2
. Cost/Burde n Sharin

g Provision s A s wa s discusse d above , th e provision s o f

sectio n 211(e)(3)(B ) provid e a mean s f

o reduce th e cos tand burden o f di e fue l and fue l additive s program . Thes e provision s permi t producers of

any fue l o r fue l additive whic h i s manufactured o r processe d b y tw o o r mor

e person s t

o share cost s o

r responsibilitie s unde r th e progra m s o tha trequirement

s ca n b e me

twithou t duplicatio n o

f effor tThi s involve s bot

h procedura

l issue s o n ho w producer

s woul d share th e cost s an

d burden s involve d and progra

m matter s o n ho w fuel s and additive s could b e groupe d fo r purpose s of

enactin g thes e provisions
. Procedura

l implementation i s discusse d below . However , th e concep to f groupin g fo r testin g purposes has sectio n 211(b)(2) implication s wit h regard t o EPA' s approac

h to implementin

g protocols , s o i

f wil l b e discusse d in a separate section
. Wit h regar d to procedura

l implementatio n o

f thi s provision ther

e are tw o possibl e situations
. Th e first involve s the cas e wher

e sufficien t information exist s fo

r th e registration of a produc twithoutthe completion o f additional testin g becaus e a manufacturer o r other entit y ha s alread y complete d th e require

d testing
. I

n thi s case , th e firstentit

y has alread

y incurred al l necessar y cost s whil e th e secon d manufacture

r migh tsee k f o simpl y us e th e results o

f thi s testin g a s sufficientexistin g testin g an d claim exemptio n from furthe

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 of simila r existin g o

r ne w product

s wh o nee d to undertake di e same testin g requirement

s prior f o registration
. Tw o o r mor e entitie s woul d expend th e sam e effor tto accomplis h the same resul tan d woul d us e th e limite d tes tfacilitie s to duplicate th e sam e tests . Sectio n 211(e) allow s the Administrato r t

o provide fo

r manufacturer

s o f th e same fue

l or additiv e to share th e cos to f complying with th e regulation s an

d he ma y als o provid e for manufacturer

s o f th e sam e fue l o r additiv e to shar

e the responsibilitie s of

complyin g wit h th e testin g regulations
. T o implemen tthi s authorit y i n th e firstcase , the manufacturer wh o conduct s test s of a produc twoul d b e recognized unde r sectio n 211(e)(3)(B ) a s havin g a rightt o cost-sharin g from other

s wh o wis h t

o reply o n tha

ttestin g fo

r purposes o

f sectio n 211
. Thes e othe

r manufacturer

s woul d notb e abl e t

o us e th e firs t manufacturer' s tes tresult s witiiout reaching a

n agreemen

to n sharin g di e cos tThe Agency invite s commen to n whethe r th e provision s should b e applicabl e t

o provid e fo

r cost-sharin g whe n on e manufacture

r has submitted tes tresults tiiatothers wis h t o rely upon i n meetin g thei r testin g obligations
. I n case s where tw o o

r mor e producer

s nee d prospectivel y t

o complet e th e sam e testing , they coul d for

m a consortiu

m t o complete th e requirement s and submit th e results a s a group . An y additiona

l manufacturer

s desiring t

o rely o n diat testin g fo r thei r produc

twoul d the

n b e charge d a fe e b y th e origina l producer

s t o us e thes e results rather tha n conduc t thei r ow n testing
. Th e agenc y request s comment s regarding thi s approac

h an d solicit s othe r suggestions
. I n all cases , unde r sectio n 211(b) , th e tes tresult s submitte d t

o EP A woul d notb e confidential
. EP A als o invite s comment

s o n some additional matter

s i n thi s area . Thes e cost-sharin g provision s woul d notb e expecte d t

o b e availabl e fo

r existin g test s i f th e ful l tes tresults have already bee n published
. Shoul d an y limit s b e se t fo r th e fee s tha

tma y b e charge

d fo r us e of tes tinformation and especiall y whe n test s are a numbe

r of year s old ? Should th e reimbursemen

tprovision s o

f sectio n 4 o f TSC A b e considere d a mode

l fo r handlin g cost-sharin g questions ? EP A ha s extensiv e experience unde r TSC A sectio n 4 with cost-sharing fo r testing
. EP

A ha s found tha

tpersons conductin g testin g under sectio n 4 have chose n i n each instanc e t o dat e t o wor k outthei r ow n arrangement s fo r cost sharing o r reimbursementwithou

tan y nee d fo r EP A involvemen tEP

A issue d regulation s i n 4 0 CF

Rpar t79 1 fo r dat a reimbursemen tI

n spit e o f th e significan tnumbe

r of tes trule s issue d unde r TSC A n o on e ha s invoked an y o f th e forma l procedure s fo

r dat a reimbursementunder di e regulations
. EP A solicit s commen

to n whether a simila r resul ti s likel y unde r th e sectio n 21 1 testin g program . 3
. Groupin

g of Fuel s an d Additive s fo

r Testin g A s wa s mentione d above , t o implementth e sectio n 211(e)(3)(B ) provisions , th e regulation s ma y includ e criteri a t o determine which fuel s o r fue l additive s are essentiall y th e sam e for th e purpose s of

deterniining potentia

l pubh c healt

h effects and meetin

g other requirements. I

f th e fuel s o

r additive s ar e essentiall y th e sam e a s othe r fuel s o r additives , groupin

g fo r testing purpose s woul d preventduplicative testin g unde

r sectio n 211(e)(3)
. Fuels and additive s ar

e complex mixture

s and , i n groupin g them , iti s necessary t

o establis h criteria fo

r judgin g i f tw o o r mor e fuels/additive s ar

e essentiall y th e same . Thi s criteria ca n initially involv e evaluatio n o

f th e chemica

l composition and/o r structura

l activit y propertie

s of fuels/additive s fo

r th e appropriat

e degree o f sameness . Suc

h categorization reduces th e burde

n o f testing , whic

h i s importan tgive n th e grea

tnumbe r o f compound s involve d and th e lac k o f tes t facilities
. Fro

m eac h o f thes e groups , representativ e and/o r possibl y toxic fuel s and additive s coul d b e selecte d t oP. 7 

# 1 1

3222 2 Federa l Registe r / Vol

. 55 , No

. 15 2 /

Tuesday , Augus t

7.199 0 /

Propose d Rule s underg o di e testin g requirements

. Thi s woul d eliminat e th e nee d fo r eac h fuel an d fue l additiv e to underg o testing

. T o accomplis h thi s end , however , potentia l group s wil l nee d to b e establishe d a s wel l a s th e criteri ab y whic h fuel s an d additive s wil l b e assigne d t o suc h groups
. Th e definitio n o

f "essentiall y th e same " b y whic h fuel s an dadditive s ca n b e groupe d ca n b e avery broa d definitio n o r

i t ca n b e narro w i n scope
. A stric t definitio n woul d grou p fuel s an d additive s accordin g t o narro w criteria , woul d emphasiz e di e difference s amon g chemicals , an d woul d therefor e resul t i n avery larg e number

of groups
. O n th e othe r hand , definin g "essentiall y th e same " mor

e broadl y woul d resul t

i n fewe r group s wher e th e difference s betwee n fuel s an d fuel additiv e group s coul d b e greater

. Unde r

mi s approach , severa l representative s o

f th e grou p might b e oubjec t

to testing , wherea s onl y on e member

may b e i n th e former

case
. (In bot h cases , thi s assume s adequat e informatio n doe s no t

no w exist)

. Fo r example , arecen t

EP A technica l memorandum

. "Analysi s of Aftermarke t Fue l Additive s Containin g Methanol " (availabl e i n Docke t

No

. A-SO-07) , show s tha t

alarg e numbe r

of di e aftermarke t

fue l additive s considere d contai n almos t

al l methanol ; however , ther e i s asmal l portio n tha t contain s a larg e number

o f othe r compound s a s wel l S n tryin g to grou p thes e additive s o n th e basi s o

f a n "essentiall y th e same " defajtooi s i t

woul d b e necessar y to determin e i

f the y shoul d b e groupe d togethe r base d o n th e fac t

tha t the y al l contai n methanol , o r

the y shoul d b e spli t int o anumber

of 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 h group tha t

i s formed, on e o r more representative s coul d b e selecte d for testin g if needed

. A s ca n b e seen , groupin g th e product s mor e strictl y coul d result

i n more tha n woul d hav e t o b e tested

. Th e provision s o

f CA A sectio n 211(f

) hav e provide d som e experienc e wit h determinin g fuel s an d additive s whic h ar e "substantiall y similar " to othe r fuel s an d additive s i n adifferen t settin g tha t focuse s o n emissio n contro l syste m effects

. S n a198 1 Interpretiv e Rul e (4 6 F R38582-38588 ; Jul y 28,1981) , EP A ha s define d a n unleade d gasolin e to b e "substantiall y similar " to 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 som e for mo f hydrocarbon , aliphati c ether , aliphati c alcoho l (wit h som e Hmitatio n o n typ e o f alcohol) , wit h ftiel additive s containin g onl y carbon , hydrogen , an d oxygen , nitrogen , and/o r

sulfur , an d meet s certai n limitation s regardin g th e amoun t o f fue l additive , sulfu

r i n th e additive , an d alcoho l presen t i n th e fuel

. Fuel s no t meetin g thes e criteri aar e no t considere d "substantiall y similar " t o th e above-mentione d certificatio n fuel

. Relate d material s ca n b e foun d i n th e publi c docket

. EP

A invite s comment s o n whethe r thes e determination s o r

similar approache s ar e useful alon e o r wit h othe r factor s fo r groupin g fuels / additive s fo

r testin g purpose s fo

r determinin g 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 di e structur e activity relationshi p shoul db e th e basi s fo

r grouping

. EP A als o plan s to examin e it s registratio n dat ato determin e if the y provid e auseful basi s fo

r groupin g fuel s an d additive s SO

T testing

. Th e results of a n analysi s to b s conducte dpursuan t to - acontrac t wil l b e include d i n th e publi c docke t whe n available

. EP

A invite s comment s o n th e appropriat e wa y t o grou p fuel s an d additive s an ddi e criteri ato b s used

. Th e mos t importan t concern i n groupin g fuel s an d additive s woul d b e thei r

samenes s fo

r purpose s of potentia l toxicit y an d emissio n contro l an d welfare/environmenta l effects

. 4

. Duplicativ e an dExistin g Test s Unde r CAA sectio n 211(e)(3)(C) , th e Administrato r

"may " exemp t

an y fuel o r additiv e fro

mth e regulation s "upo n a finding tha t

an y additiona l testin g of suc h fue l o r fue l additiv e woul db e duplicativ e o

f adequat e existin g testing. " Moreover , unde r

sectio n 211(c)(2)(A) , th e Administrato r ca n onl y contro l o r regulat e afue

l o n di e basi s of al l relevan t

medical an d scientifi c evidenc e availabl e to him

. T o structur e th e testin g programan d t o determin e i

f ther e i s duplicativ e testing , i f i s importan t

f o obtai n result s fro mexistin g test s o n fue

l an dfue l additive s a t

a n earl y poin t

I f i s als o necessar y t o determin e wha t testin g ha s bee n initiated

. Sinc e i t

typicall y fake s severa l year s fo

r arepor t f o b e mad e publi c t o avoi d unnecessar y duplication , i t

i s importan t

f o b e knowledgeabl e abou t

ongoin g work

. Testin g to dea l wit

h som e of th e health , emissio n o r

welfare effect s of

fuel s an d fue l additive s ma

y hav e bee n conducte d fo r variou s reason s an d b e availabl e fro mvariou s sources
. In connectio n wit

h thi s proceeding , t o hel p obtai n informatio n o n existin g testin g o n atimel y basis , EP A i s considerin g amendin g th e registratio n provision s i n 40 CF

Rpar t 79 , subpar t

D (implemente d emde

r sectio n 2tl{bXl))

. t o ensur e tha t

producer s provid e a summar y of an y publishe d testin g o r

a detaile d repor t

of unpublishe d result s don e b y th e produce r

includin g test s fo

r EP A o r othe r governmen t

agencie s tha t relat e t o healt h an dothe r effect s covere d b y sectio n 211

. Thi s include s carcinogenicity , mutagenicity , teratogenicity an d othe r

healt h effect s o

f ra w fuels/additives , combustio n an d possibl y atmospheri c transformatio n product s a s wel l a s informatio n o n di 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 health an dwelfar e i n general

. Furthermore , a s par t

o f th e possibl e progra mprotoco l describe dbelow , EP A ma y require th e manufacturer s t o conduc t aliteratur e searc h an dsubmi t studie s o r asummary o

f availabl e informatio n relatin g t o th e hazard s an d impact s of

th e fuel(s ) o r

additive(s ) th e manufacture r

produces

. Suc h informatio n ca n b e considere d reasonabl e an dnecessar y t o determin e th e exten t t o whic h emission s affec t th e publi c healt h an d welfar e unde r sectio n 211(b)(2)

. EP A see s dii s a s ake y provisio n an d invite s comment s o n thi s measur e an d o n th e criteri aan dprocedure s tha t shoul db e use d t o determin e whethe r an y fuel o r

additiv e shoul d b e exemp t o n th e ground s tha t

adequat e existin g informatio n exists

. D. Health Testing Protocols and Requirement

Issues Sectio n 2M(b)(2 ) provide s tha t test s ar e to b e conducte d accordin g to tes t procedure s an d protocol s establishe d b y th e Administrator

. Th e sectio n coul d b e rea da s simpl y requirin g adherenc e f o specifi c guideline s identifie d b y EPA , r atiler tha n requirin g EP

A to establis h specifi c tes t

plan s o r procedure s i n ever y cas e befor e testin g i s done

. EP A migh t provid e fo

r di e us e of

generall y accepte d o r

bes t availabl e scientifi c tes t guideline s o r

plan s i n th e absenc e of

a requiremen t

for aspecifi c procedure

. Th e statut e als o doe s no t

specif y th e exten t t o whic h th e tes t

requirement s shoul db e mandate d b y regulation, identifie d i n guideline s a s acceptabl e models , o r

establishe d o n acase-by

cas e basis

. Give n th e larg e numbe r

of fuel s an d fue l additive s an dth e compound s containe d therei n an dth e potentia l numbe r of healt h effect s endpoints , identifyin g appropriat e tes t guideline s i s importan t Thi s sectio n reviews th e currend y availabl e healt h testing an d risk assessmen t

guidelines , th e factor s bearin g o n th e nee d to develo p - guidelines , an d ask s for

comment s o n th e bes t approac h to mee t

th e requirement s o f

th e Ac*

.P. 8

Fedmi d Registe r i Vo l 55 , N a 152/Tuesday
. Augus t7.199 0 / Propose d Rale s • ^^-^ftf l



# 1

:?? • 1
. Existin g Heart h Effects Testin g Protocol s Ther e ar e severa l existin g source s o f establishe d healt

h testin g guidelines
. Thes e includ e th e TSC A Healt h Effect s Testin g Guideline s (4 0 CF Rpar t798)
. Federal Insecticide , Fnrrgicide , and Roderrtfcid

e Ac t(FIFRA

) Toxicology Data Requirement

s (4 0 CF R158.340) , an d th e Organizatio n fo

r Ecrmorni

c Cooperatio n and Development(OECD ) Guideline s for Testin g o f

Chemicals. * I n addition , there hav e bee n severa l studie s commissione d throughou tth e pas t1 0 year s whic h were aime d a t determinin g a propose d approac h for testin g o f fuel s an d additives.* , * , * , • Eac h o f th e five set s of

establishe d healt h testin g guideline s mentioned abov e represents generally-formulate d procedure s for laborator

y testing o f

a n effec to r characteristi c deemed - importan tfar th e evaluatio n o

f healt h an d environmenta

l hazard s o

f a chemical
. Th e healt

h effects tha

tar e indnde d ar

e primaril y acute , subchronic , an d chroni c toxicology (dermal , ora l an d inhalation) a s wel l a s oncogenicit

y en d geneti c toxicology
. Thes e protocol s provide guidanc e and t o a varyin g degre e detail s o n acceptabl e model s o

f testin g design , ba t mor e specifi c guidanc e ma

y b e neede d i n particular cases . However , the potential scop e c f

di e fue l an d fue l additiv e testin g progra

m i s sach tha

t providin g thes e specific s beforehan d i n eac h cas e i s generall y impractical
. EP A invite s comment

s o n the adoption o

f thes e guideline s for fue

l and fue l additiv e testin g and o n th e extentt o whic h mor

e specifi c guidance i s neede d an d the manne r i n whic

h i tshoul d b e provided
. Whil e resourc e intensiv e fo r EP A and time consuming , on e possibl e approac h fo r th e mor

e comple x an

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

h migh trequir e th e producer t o prepar

e tes tplans fo

r EP A

» "OEC D Guideline s fo r Testin g o f Chemicals" : ISB N 92-64-12900-6:1981
. 9 "Possibl e Approache s to th e Healt h Effect s Testin g o f

Fuel s an d Fue ! Additives" : Litto n Bionetics
. Inc. : Technica l Directiv e No . 008
. EP A Contrac tNo . 88-02-3682 : Draf tRepor tJul

y 1983
. 4 "Us e o f Short-Ter m Genotoxir , Bioaway s i n th e Evaluatio n o f

Unregulate d Automobil e Emissions" : Litto n Bionetics
. Inc : EP A Contrac tN a 68-02-3682 : Fina l Repor tOctober
. 1983
.
• "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 Testin g o f Twelv e (12 ) Vapor
Phas e Compounds" : EP A Contrac tNo . 68-02-3170
- 08 2 EPA-600/1-64-005 ; March . 1984
. * "Testin g fo r Heait h Effect s o f Fuel s an d Fue l Additiws" ; Southwes tFoundatio n fo r Researc h an d Education : EP

A Contrac tNo . 68-02-2288 : Draf t Repor t197 a approva l a s i s presentl y use d b y EP A i n its TSC A sectio n 4 tes trule fo

r drbenzo
para-moxms/dibenzofurar M (4 0 CF R par t766)
. Alternatively , EP

A migh t allo w th e produce

r t o develo p the plan s and conductsuc

h testin g withou

tEP A approva l bu twit h EP A approva

l o f the acceptabilit

y o f the result s an d retestih g i f unacceptable . Becaus e o

f the numbe

r o f fuels / additive s tha

tcoul d b e tested , iti s desirable , if

possible , t

o hav e mode

l guideline s tha

i can b e use d withoutth e nee d fo r a uniqu e plan an d EP A revie w i n eac h case . Ar

e th e presentguidelines , particularl

y th e TSC A guidelines , sufficientt o achiev e th e goal ? Should th e guideline s b e presumed t o b e appropriat

e unless , i n a particula

r case, a manufacture

r show s the nee d fo

r o r appropriatenes s of

usin g differen

t guidelines ? A major issu e i s th e availabilit y and appropriatenes s o

f variou s guideline s for testin g emissions/combustio n products . A s i s discusse d and reference d below , th e carcinogenicit y o f diese l fue l a s combusted has bee n tested . D o th e testprotocol s use d i n thes e studie s provid e a n appropriat e model fo r testin g o

f th e conibustia

n product s o f fuel s and fue

l additives ? Wha tprocedures shoul d EP

A us e fo r protocol revie w and atwha tpoin t shoul d thes e review s occur i f needed ? I n additio n t o th e healt

h effect s testin g guidelines , EP

A ha s als o issue d five risks assessmen tguidelines : (1 ) "Guidelines far Carcinoge n Rid e Assessment " (5 1 F

R33992-34003
. Septembe r 24.1986) ; (2

) "Guidelines for Mrkagenicit

y Ris k Assessment " (5 1 F

R 34008-34012
. September 24.1986) : (3 ) "Guidelines fo

r th e Healt

h Ris k Assessmen tof

Chemica l Mixtures " (5 1 F R34014-34025 , September 24.1986) ; (4) "Guidrfrnfisfc

r th e Healt

h Assessmen t o f SuspectDevelopmenta

l Toxicants " (5 1 F R34028-34040
. September 24.1986) : and (5 ) "Guidelines fo

r Exposur e Assessment " (5 1 F

R34042-34054
. September 24.1986)
. Also , durin g the las tfe w months EP

A ha s propose

d ne w guideline s fo

r reproductiv

e ris k assessment s and a ne w guideline tha t supplement

s the guidance in the 198

6 exposure guidelines
. Thes e are : (1 ) "Propose d Guideline s fo

r Assessin g Male Reproductiv

e Ris k an d Requestfo

r Comments " (5

3 F R24850-24869
. Jun

e 30
. 1988) ; (2 ) "Propose

d Guidelines fo

r Assessin g Femal e Reproductiv e Risk ; Notice " (5

3 F R24834-24847 , Jun

e 30 , 1988 h (3) "Propose

d Guidelines fo

r Exposure-Related Measurement s and Reques tfor Comments : Notice " (5 3 F R 48830-48853 , Decembe r 2.1988) : an d (4) "Propose d Amendment

s t o the Guideline s fo r th e Healt

h Assessmen tof SuspectDevelopmenta

l Toxicants ; Reques tfor Comments , Notice " (5 4 F R 9386-9403 , Marc

h 6.1989)
. EP

A request s commen to n th e applicabilit

y o f the risk assessmen tguideline s t

o th e progra

m t o b e develope d under sectio n 211(b)(2)
. 2
. Laborator

y Capabilitie s A secon d importan

tfacto r t o conside r i s th e capabilit

y of the nation' s testin g facilitie s t

o handl e the volume o

f testin g tha tcoul d potentiall y b e generated bot h i n th e nea r ter

m and i n th e future
. EP

A invite s commen

to n the existin g capacit

y fo r such testin g a s wel l a s the capabilitie s amon

g testin g facilities
. I

f onl y a limite d nmnbe

r of laboratorie s ar e capabl e o

f performin

g a certain test th e prioritie s for testin g mus tb e carefully considered , especiall y i n th e shor tterm, s o a s no tt

o undul y burde n producer s and testing facilitie s an

d t o ensur e soun d tests . Fa

r example , th e EP A staf f i s aware o

f only approximately thre

e facultie s capabl e at presentof conducting inhalatio n studie s wit h vehicula r combustio n emissions
. EP A especiall y invite s commen tfro m th e scientifi c communit

y a n the capabilit y o f testlaboratories , and i s no w conductin g a n independentstud y o f curren tcapabilities
. Thi s report , entitled
. "EP

A Censu s o

f the Toxicological Testin g Industry" , wil l b e place d i n di e docke twhe

n completed . 3
. Heart h Effect s Endpoint

s A s discusse d earlier , th e CA A provide s for tb e Administrato r t o requir e testin g t o determine potentia

l publi c healt h effect s indnrrrn

g carcinogenicity , mutagenicity , and teratogenicity
. Testin g i s no tnecessaril y t o b e limited t o tiiese healt h effect s but. rather, ma

y includ e testing for systemi c toxicity , cardiovascula r and inhalatio n fffw^s , neurotoxicity , metaboli c effects , acute effects (oral , dermal , inhalation) , effects o n mucous membranes , etc . The legislativ e histor

y indicate s tha

tth e testin g protocol s shoul d b e "reasonabl y comprehensive"
. H.R

. Rept . No . 95-294
. 95t h Cong.
. 1s tSess
. 30

9 (1977)
. Thi s rulemakin g wil l determine whic

h healt h effec tendpoints nee d t

o b e included a s par to f th e testin g program

. 4
. Exposur

e Routes an

d Level s Alon g wit h determinin

g whic h healt h effectendpoints t

o includ e in th e program , th e routes and level s o

f exposure t

o fuels , fue

l additives , and . thei r emission s mus

tals o b e decide d fo

r anima l testing
. Peopl e ar

e expose d t o the ra w fue l o r additiv e itsel f

throug h accidental ingestio n o

r ey e an d ski n contact . Th e inhalatio n o

f vapor s als o if.P. 9



### 3222 4 Federa l Registe r / Vol . 55 , No . 15 2 /

Tuesday , Augus t7 . 199 0 / Propose d Rule s

cause s contac

twit h th e ra w fue l o r additive
. Combustio

n product s a s wel l a s atmospheric transformatio n product s o f the emission s o

f fuel s and additive s ar e usually inhaled o

r ma y caus e a wid e arra y o f effects
. Thes e exposure scenario s indicat

e tha tth e mos tlikel y route s o f exposur e woul d b e inhalation , oral , dermal, and ocular. Beside s route o

f exposure , i n dealin g with emission s o

f fuels/additives , iti s als o importan

ttha tthe pollutantlevel , duration , an

d patter n of exposure fo

r the tes tprotocol s b e determined
. Concentrations use d ar

e usuall y muc

h higher i n laborator

y test s tha

n encountere d i n th e environmen tbecaus e th e laborator

y test s ar e conducte d o n a smal l numbe

r of animal s and ar

e suppose d t

o provide results mor

e quickly tha

n they coul d b e observe d in th e natura

l situation
. Exposur

e ca n b e a singl e exposure , long term, o r ca n occur a tintervals
. Periodic exposur e ca n occur a tregula r o r varying intervals
. I

n addition , durin

g periodi c exposure , th e concentratio n can eithe r b e unifor m o r increasing/decreasing
. Sinc e significantexposure t o motor vehicl e fuel s an d fue

l additive s i s i n th e for m o f combustio n and atmospheri c transformatio

n product s presen ti n th e ai r they breathe , i ti s appropriat e tha t thes e b e considere d i n an y testin g program . Atmospheric transpor

tan d transformation o f

emission s may lea d t

o increase d toxicity
. I

n addition , th e fue

l formulation itsel f

impact s ai r qualit

y an d healt h effects b y contributing toward ozone , formaldehyde , an d other toxic s and/o r carcinogens
. I n testin g combustio n products , ho w shoul d th e tes tsampl e b e determined ? Shoul d th e whol e exhaust , fractionated samples , o r som e combination of

thes e b e tested and , i f so , wha tcriteri a shoul d b e applied ? T o wha texten tand i n wha t wa y shoul d thi s progra

m conside r atmospheri c transformatio n products ? 5
. TSC A Guideline s and Tes tCriteri a EP A i s considerin g usin g som e o f th e basi c approaches and tes tprocedure s implemente d unde

r TSC A for evaluatin g chemica l substance s a s guidanc e i n developin g testin g criteria an d tes t method s fo

r fuel s and fuel additives
. Th e underlyin

g testin g philosoph y and regulator y approac h of TSC A woul d b e use d a s guidance i n developin g testin g criteri a and tes tmethod s for us e i n th e fuel s and fue

l additive s testin g program. Th e standardized guideline s fo r healt h effects , environmenta

l effects , an d chemical fate test s ar

e foun d at4 0 CF

R part s 79 5 throug h 798
. Under sectio n 4 of

TSC A testin g of chemical s t

o develo p dat

a i s required i

f th e Administrator make s certai n findings a s describe d i n TSC A sectio n 4(a)(1 ) (A ) o

r (B)
. I n TSC A sectio n 4 tes t rules , EP A specifie s th

e individua

l tes t requirements
. A generally formulate d se to f tes tprocedures , know

n a s TSC A tes tguidelines , ar

e usually adopte d a s tes trequirements
. Thes e guideline s specify , when appropriate, tiered testin g scheme s whic

h us e short-term, les s expensiv e test s t

o trigge r subsequent, mor e comple x test s o r batterie s o

f tests . (See , e.g., 4

0 CF R799.250 0 an d 3175. ) Thes e longer-ter

m tests , suc

h a s cance r bioassays , ar

e muc h mor e costly . Determinations o

f whether longer-ter

m testin g i s necessary ar

e mad e o n a n individua l chemica l basis
. Unde r TSC A sectio n 5 , EP

A screen s ne w chemica

l substance s befor

e manufactur

e i s permitte

d t o asses s thei r potentia l t o caus e injur

y t o huma n healt h o r di e environmen tUsin g finding s simila r t o thos e unde

r TSC A sectio n 4, i

f EP A finds tha

tavailabl e informatio

n i s insufficien

tt o permi t reasonabl e evaluatio n o f

th e healt h an d environmenta

l effect s o f a ne w substanc e and , in the absenc e o f suc h information , activitie s involvin g th e substanc e ma

y presenta n unreasonabl e risk, EP A ma y regulat e activitie s involvin g th e ne w substanc e pending developmentof

sufficien tinformation
. I

n addition , EP

A ma y regulat e a ne w substanc e where th e informatio n i s insufficien tand th e substanc e wil l o r ma y b e produced i n substantia l quantitie s an d ther

e i s o r ma y b e significan tor substantia

l huma n exposure t

o th e chemica

l o r th e substanc e ma

y reasonabl y b e anticipate d t o ente r th e environmen ti n substantia

l quantities
. Suc

h testin g mus

t b e completed and evaluate d t o EPA' s satisfactio n befor

e unrestricted commercia

l manufactur

e or impor

tma y occur . Test s ar

e selecte d fo

r thes e chemical s o

n th e basi s o

f th e healt h o r th e environmenta

l en d point(s ) identifie d durin

g th e assessmen t Specifi c test s ar

e frequently base d o n th e TSC A Tes tGuidelines
. EP A invite s commen

to n th e suitabilit y o f th e TSC A criteria i n developin g testing requirement s and tes t method s fo

r fuel s and fue

l additives
. The legislativ e histor

y o f sectio n 211(e) indicate s tha

tEP A shoul d us e relativel y inexpensiv e bu

treliabl e testmethod s insofar a s possible
. H-R

. Rep L No . 95
- 294,95t h Cong
. 1s tSess
. 30

9 (1977)
. Comment s ar e particularl

y invite d o n th e suitabilit

y of the tests use d i n th e TSC A tes trules a s reliable tes tmethod s fo r us e unde

r sectio n 21 1 and o n th e criteria tha

tshoul d appl

y t o fuel s and additive s wit

h a hig h production volum e and a significan

to r substantia

l leve l of exposure . E. Analysis of Section 211 Time Requirements forSubmittal of Requisite Information Sectio n 211(e) requires tha tth e "requisit e information " b e provide d t o EP A b y eac h manufacturer withi n thre e year s fo r existin g fuel s and fue

l additives , an

d prio r t o registratio n for thos e notregistered a

tth e tim e th e rule i s promulgated . Th e legislativ e history fo r thi s provisio n indicate s tha tal l of th e requirement

s ar e mandatory , a s ar

e th e date s by whic

h the required tes t information mus

tb e submitte d b y th e manufacturer

, subjectt o specifi c statutor y exceptions
. H.R

. Rept . No . 95
- 294 , 95t h Cong. , 1s tSess
. 308 (1977)
. However , th e sam e repor tof th e Hous e Commerc

e Committee als o indicate s tha

tth e regulation s are no t intende d t

o b e "undul

y burdensome"
. Th e Administrato r i s expecte d "t o tak e cost s int o accountin promulgating tes t requirements"
. HR. Rep tNo . 95-294 , 95t h Cong
. 1s tSess
. 30 9 (1977)
. Th e Hous e Committe

e als o expecte d EP

A t o utiliz e a s fa

r a s possibl e th e "[relativel y inexpensiv e butreliabl e testmethods " whic h are becomin g "increasingl y available"
. The "paramoun tinterest " i n protecting th e pubh c health require s tes t protocol s which ar

e "reasonabl y comprehensive " with respec tt o a numbe r of healt h effects
. Ibid. A s wa s discusse d above , there appears t o b e som e tension betwee n th e ful l potential scop e o f

th e testin g requiremen

to f sectio n 21 1 an d th e Congressiona

l goal tha tth e implementing regulation s no tb e "undul y burdensome"
. Special difficultie s ca n aris e i f comprehensive testin g of al l existin g fuel s and fue

l additive s mustb e undertake n and complete d withi n thre e year s of th e promulgation o f

th e regulations
. Suc

h a fixed time schedul e ca n b e detrimenta

l t o conductin g soun d and adequat

e scientifi c studies
. Long
ter m studie s of

healt h effect s ca n ofte n take longer tha

n three years . Inhalatio n test s fo r carcinogeni c effect s may no t sho w effect

s unti l after 3 0 month s o f exposure. 7 The additional time t o se tu p th e study and evaluate tes tresult s woul d effectivel y preclud e submissio n of th e results withi n thre e years . A narrow interpretation of

thi s provisio n woul d limi ttestin g t

o thos e test s that are possibl e t

o complete i n thre e year s rather tha n test s tha

tmay b e mor

e adequat e and appropriat

e t o determin e potentia l publi c healt

h and emissio n effects
.

* "Healt h Assessmen tDocumen

tfo r Diese l Emissions; " Offic

e o f Researc h and Developmen t U.S
. Environmenta

l Protection Agency ; Draf

t Repor tMa y 25,1990
.P.1 0

¥mdm.Ma^st«tJVel.SS, N a 152 / Tuesday , Augns t7 , ffl W / fwtpoaes l Rde «

V! i A s discusse d above , a three-yea r tim e perio d t o complet e an y required testing woul d als o strai n th e presentl y availabl e laborator y griffta

—far conductin g studies , particulari y chroni c studie s suc h a s inhalatio n studies

. Whil e mor e informatio n o n laborator y capabilit y i s needed , th e presen t indication s ar e tha

tth e limite d tes t facilitie s availabl e mak

e i t iirrpractical t o complet e oi l testin g of

al l fuel s an d fuel additive s withi n thre e years
. I 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 tb e additiona l testin g tha t wil l b e needed

. Manufacturer s ma y b e exempte d fromfurther

testing i f adequat e existin g testing ha s alread y bee n conducted

. Th e exten t an d adequac y of

th e existin g testin g wil l hav e t o b e determined

. Cost-sharin g b y manufacturer s i s encourage db y th e

. statut e an d thi s shoul d reduc e th e amoun t o f testing required fo

r essentiall y th e sam e substances

. Furthermore , th e legislativ e history encourage s th e us e o

f relativel y inexpensiv e bu t

reliabl e tes t

method s i n s o fa r a s i s possible

. Still , som e additiona l testing i s likel y t o b e neede d an d thes e need s ma y surpas s th e capabilit y o

f laboratorie s t o complet e withi n thre e years
. EP A invite s commen t o n appropriat e way s t o dea l wit h th e tensio n betwee n th e time neede d fo r adequat e testin g an d th e limite d laborator y capabilitie s o n th e on e han d an d th e statutor y time perio d fo r submittin g requisit e informatio n o n th e other

. Th e Agenc y i s explorin g severa l possibl e approache s an d thes e ar e outline d belo w fo

r discussion , alon g wit h relate d issues

. Comment s ar e invite d o n whethe r

an y o f thes e approache s shoul d b e pursued , e r o n whethe r ther e ar e alternativ e approache s tha t

shoul d b e considered

. 1

. Requisit e Informatio n On e approach , whic h appear s soun d an d consisten t

with th e Ac t

woul db e t o vie w th e requiremen t

in sectio n 211(e) tha t "requisit e information' ' b e submitte d i n thre e year s a s applyin g t o th e informatio n an d tes t

result s tha t EP A determine s i s neede d fo r regulator y decisio n makin g an d ca n b e complete d withi n th e thre e years
. Test s whic h canno 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 statutor y tex t o f sectio n 211(e)(2) refers to th e submissio n o

f "requisit e information " require d b y regulatio n t o implement th e authorit y unde r

sectio n 211(b)

. Th e authorit y unde r

sectio n 211(b ) tha t

EP A i s required t o implemen t

b y sectio n 211(e ) state s tha t

EPA may requir e manufacturer s t o "conduc t tests " t o determin e "potential publi c healt h

effects, " and to submi t

suc h othe 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 sectio n 211(e) n o longer

leave s EP

A an y discretio n o n whethe r

t o nnpleraen t sectio n 211(b) , subsectio n (b ) relie s o n EP A t o exercis e judgment

i n determinin g th e testin g neede dt o mee t th e statutor y aims

. In th e regulation s rmplemerrting sectio n 211(b)

. EP

A woul d exercis e it s judgmen t to establis h a fue

l an dfue l additive s programtha t

wil l mee t th e testin g requirement s o

f th e Ac t Unde r suc h a n approach , producer s of al l existin g fuel s an dfue

l additive s woul d hav e t o submi t

certai n informatio n withi n thre e year s of

promulgatio n of th e final regulation

. Thi s submissio n woul d contai n th e requisite informatio n calle dfo r b y th e regulations includin g th e result s o

f screenin g tests an d an y othe r testin g require d and/o r

previousl y completed

. Long-ter

mtest s woul dhav e t o b e submitte di

f require dan 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 n i t

i s no t possibl e t o submi t adequat e studie s i n tha t

time perio d a s discusse dabove

. Th e obligatio n o

f manufacturer s "t o conduc t tests " woul db e fulfilled b y a n undertakin g t o complet e test s a t alate r tim e whe n i t

i s no t possibl e t o finish th 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 EP

A b y an y specifi c dat e se t b y EP A i n anotic e t o th e manufacturer s o r

publishe d i n th e Federa l Register

. Submissio n o f studie s after th e initia l three-year

perio d woul d als o b e permitte d whe n adequat e laborator y facilitie s ar e no t availabl e t o conduc t tests i n dia t

tim e perio dan di s otherwis e neede dt o mee t th e Congressiona l goals

. EP

A woul d conside r identifyin g prioritie s fo

r completin g studie s whe n ther e ar e insufficient

testin g facilities

. Suc h a n approac h i s als o i n accordanc e wit h sectio n 211(b)(3 ) whic h provide s tha t registrant s wil l giv e assurance s tha t the y wil l submi t

additiona l informatio n whic h reflect s "change s i n th e informatio n required" fo

r registration

. Furthermore , a s discusse dabov e i n connectio n wit

h th e methano l petition , di e Agenc y als o ha s th e optio n t o us e it s authorit y unde r

TSCA in conjunctio n wit h sectio n 21 1 t o ensur e tha t adequat e testin g i s submitted

. TSCA migh t b e use d t o provid e additiona l assuranc e tha t studie s ar e complete dan d submitte d on atimely basi s especiall y whe n th e test s tak e longe r dia n th e thre e years
. 2

. Three-Year Tes t Perio d Anothe r possibilit y i s that

th e requiremen t

i n sectio n 211(e) fo

r submittin g requisit e informatio n i n thre e year s fo r registere dfuel s shoul db e rea d t o appl y onl y t o th e typ e o f test s an d informatio n tha t

ca n b 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 n thre e years
. Congres s mus t hav e envisione d (h e us e o

f test s dia t ca n b e complete d withi n thi s time period

. In thre e year s i t

i s more feasibl e t o complet e literatur e searches , screenin g studies , an d short-termstudie s a s woul d b e consisten t

wit h atie r

testin g approach

. Thi s typ e o

f infannatio n ca n als o hel p th e Agenc y make a preliminar y assessmen t

o f th e potentia l fo r publi c health , emissio n contro l an d welfar e effects

. Th e informatio n ca n guid e th e Agency' s decisio n makin g an d hel p t o identif

y th e nee d far farther testing

. I f studie s tak e longer

than thre e year s t o complete , the y woul d no t b e subjec t t o th e sectio n 211(e

) requiremen t

I f additiona l testing i s required , th e Agenc y coul dus e it s authorit y unde r

TSC A t o requir e th e submissio n o f

complete d .tomes

. Moreover , sectio n 211(b)(2) and (3 ) ca n b e viewe d a s arrthority trade r whic h di e Agenc y ca n continu e to reqtnr e additiona l testin g wheneve r neede d eve n if th e tests canno t

b e complete d i n th e thre e yea r

perio didentifie d i n sectio n 2Hfe l
3

. Enforcemen t

Discretio n Whil e perhap s no t

prefered , anothe r approac h woul d recognize tha t whil e sectio n 21 1 require s th e submissio n o f al l requisit e informatio n withi n thre e years , di e Agenc y ha s discretio n i n takin g enforcemen t

action

. Th e Agenc y coul d issu e guideline s tha t woul d recogniz e tha t

absen t unnsna l circumstances , enforcement actio n woul dno t

b e a n appropriat e priority whe n mor e tim e i s neede d to complet e studie s o r whe n th e limit s o

n laborator y facilitie s dela y th e completio n of studies

. I n thes e guidelines , th e Agenc y coul d identif

y priorities base d o n publi c healt h factor s fo

r havin g test s completed

. Th e ai mwoul d b e t o ensur e earl y testin g o

f substance s wid i th e greatest-potentia l fo

r extensiv e advers e effects

. Se e Heckler

v
. Chaney. 47 0 U.S

. 82 1 (1985) , an d Cutler

v
. Hayes. 81 8 F.2 d 87 9 (D.C

. Cir

. 1987)

. 4

. Temporar y Registration s Finally , ther e i s on e allie d issu e relatedt o requirement s fo r submissio n o f th e requisit e information

. Whe n a particula r fuel o r fue l additiv e ha s no t previousl y bee n registered , but i t i s3222

® Federa l Registe r / Vol

. 55 , No

. 15 2 /

Tuesday , Augus t

7 , 199 0 /

Propose d Rule s
essentiall y th e sam e a s aregistere d fue l o r additiv e fo

r whic h testin g i s stil l ongoing , shoul d atemporar y registratio n eve r b e availabl e fo

r di e ne w fuel o r additiv e whil e th e testin g i s bein g completed ? Sectio n 211(e) allow s registere d fuel s an d additives thre e year s t o submi t

th e requisit e informatio n bu t i t require s informatio n regarding ne w fuel s an d additive s prio r t o registration

. A temporar

y registratio n i n thi s circumstanc e woul d hel p guard agains t anti-competitiv e effect s fro mth e testin g requiremen t

whe n th e substance s pos e substantiall y similar risks. Shoul d temporary registration s b e availabl e i n thes e o r

an y othe r circumstances ? Wha t

legal analyse s woul d support

thei r availability ? EP A seek s comment s o n al l o f thes e approache s an d consideration s i n developin g apla n t o implement section

. 211

. EP A i s stil l i n th e proces s o

f developin g it s regulatory approach , an d i s intereste d i n suggestion s fo r an y othe r approache s tha t

shoul d b e considered

. F. OUier i°wgram Issues 1

. Lo w Volum

e Consideratio n A s par t o f establishin g protocol s an d determinin g potential risks, EP A i s considerin g specia l provision s i f th e overal l industry-wid e annua l productio n volum e i s les s tha n agive n threshold

. Lo w productio n volume s usuall y resul t i n lo w exposure s an d thus adiminishe d ris k an d nee d fo

r comprehensiv e testing

. O f course , th e potenc y o r

toxicit y of

th e compound s involve d woul d als o hav e f o b e considered

. Comment s ar e requeste d o n thi s subject , includin g wha t exception s woul d b e appropriat e an d informatio n t o support

an y specifi c definitio n o r

exceptio n suggeste d i n th e commen t EP A als o request s commen t o n th e applicability o f

th e criteri ause d unde r TSC A fo r differentiatin g lo w volume , smal l busines s entitie s from large r entities

. 2

. Reportin g Requirement s An y testin g progra

mtha t i s develope d wil l entai l som e degre e o

f reporting

. Exacd y ho w muc h an d i n wha t formthi s informatio n shoul d b e submitte dneed s t o b e established

. Currendy , for purpose s of

registration , marketer s of fuel s an d additive s mus t

submi t afuel o r additiv e notificatio n formcontainin g suc h informatio n a s th e commercia l name , chemical composition , percen t b y weigh t o f eac h componen t

an d purpos e i n use
. Thi s informatio n i s submitte d f o EP A o n astandar d form. With respec t to di e additional ! informatio n tha t mi l nee d t o b e provide d omos testin g regulations ar e promulgated , ho w shal l thi s informatio n b s submitted ? EP A doe s no t inten d to accep t summarie s o

f unpublishe d data ; therefore , adetaile d repor t woul db e necessary
. For

researc h tha t ha s bee n publishe di n peer
reviewe d literature , EP

A believe s a summary o

f th e report

wil l b e adequate

. Shal l thi s informatio n b e submitte d o n standar d form s o r

shal l th e forma

t b e th e responsibilit y o

f th e registrant ? Th e Agenc y request s comment s o n th e reportin g detai l necessar y an don th e typ e of forma t t o use
. 3

. Evaluatio n o

f Tes t Result s an d Determinatio n o

f Regulator y Actio n Onc e adequat e test s hav e bee n complete d an d th e requisit e informatio n ha s bee n submitte dt o EPA , th e Agenc y wil l nee d to asses s th e submission s t o b e sur e adequat e testin g ha s bee n don e an d to determin e whethe r an y further testin g o r regulatory actio n i s needed

. On e valu e o

f di e testin g progra

mi s th e informatio n i t

provide s t o th e decision

makin g process
. I

n addition , sectio n 211(c ) provide s that , based o n th e informatio n obtaine dunde r sectio n 211(b)

. th e Agenc y ma y contro l o r prohibi t fuel s o r fue l additives whic h "may reasonably b e anticipate d to endange r th e publi c health o r

welfare " o r impai r emissio n contro l systems

. Befor e takin g an y suc h actio n di e Administrato r

mus t conside r al l relevan t informatio n available , includin g othe r mean s of achievin g emissio n standards

. Th e Administrato r

mus t als o conduc t

a cost-benefi t

analysi s comparin g emissio n contro l system s tha t requir e th e propose d contro l o r

prohibitio n with thos e tha t d o no t I n additio n unde r sectio n 211(c)(1)(C) , th e Agenc y canno t prohibi t th e fue l o r additiv e if

th e restriction woul d lea dto th e us e o f an y othe r fuel o r additiv e whic h wil l endange r th e publi c healt h o r

welfare t o th e sam e o r

greate r degree

. If , however , amore suitabl e substitut e becam e o r wa s availabl e dia l wa s les s dangerou s t o th e pubh c healt h o r

welfare , the n actio n coul d b e take n to restric t th e more hazardou s fuel/additive

. Thes e determination s cal l fo r carefu l analysi s an dconsiderabl e information

. Th e startin g basi s for

judgin g wha t actio n i s neede d i s th e existenc e an d degre e of ris k pose dto th e publi c healt h an d welfar e o r

emissio n contro l system

. EP A invite s comment

o n th e appropriat e proces s i f shoul d us e to evaluat e tes t results submitte d unde r

sectio n 211(b ) t o determin e th e adequac y of th e testin g done , an d th e existenc e of arisk to th e publi c healt h an d welfar e an dth e appropriat e regulatory actio n t o b e take n i n ligh t

o f th e constraint s identifie d i n sectio n 211(c)

. On e possibl e alternativ e woul db e for EP A t o evaluat e th e tes t

results a s a n interna l proces s a s par t of a determinatio n whethe r

furthe r testin g o r regulatory actio n i s necessary
. Unde r thi s approach , if

EP A decide dacontro l o r ba n o f di e fuel o r

additiv e wa s necessary , i t

woul dcommenc e rulemakin g unde r

sectio n 211(c)

. I

f i t decide dn o regulatory actio n wa s required , n o forma

l announcemen t woul db e mad e an dn o formal publi c evaluatio n woul db e mad e b y EP A o f th e tes t result s submitted

. Th e tes t result s themselve s woul db e publi c unde r sectio n 211(b)

. A n alternativ e approac h woul d b e fo r EP A t o establis h aforma ! revie w proces s t o evaluat e th e tes t result s o n a scientifi c basis , t o determin e th e nee d fo r more tests , an d announc e publicl y th e exten t t o whic h th e studie s submitte d ar e adequat e an deithe r sho w o r d o no t sho w apotentia l publi c healt h risk o r welfar e effect

an dth e degre e of risk involved

. Suc h areview proces s may o r may no t involv e participatio n b y outsid e scientifi c expert s t o advis e EPA

. Comment i s invite d o n whethe r

th e Agenc y shoul destablis h aforma l revie w proces s f

o evaluat e th e result s of th e testin g don e an d th e for man y revie w shoul d take , an dth e prioritie s fo r reviewin g th e test

result s fo r

differen t categorie s of

fuel s an d fue

l additives

. 4

. Consequence s o

f Failur e t o Submi t Requisit e Informatio n Whe n th e sectio n 211(b ) regulation s ar e issued , EP

A wil l nee d t o ensur e tha t suc h regulations ar e followe dan d th e requisit e informatio n i s submitted

. Th e CA A contain s specifi c provision s tha t nee d t o b e considere d i n ensurin g complianc e wit h sectio n 211

. Unde r sectio n 211(d)

. th e manufacture r ca n b e assesse d a$10,000 civi l penalt y fo r eac h an dever y da y o

f failure t o submi t informatio n required unde r subsectio n (b)

. In addition , unde r

sectio n 211(e) , a ne w fue l o r fuel additiv e i s f

o provid e th e requisit e informatio n prio r to registration

. Sectio n 211(c ) als o provide s for th e issuanc e of

regulation s t o restric t

th e us e of fuel s an d fue

l additive s unde r certai n conditions

. Sectio n 211(e ) provide s tha t

th e Agency' s regulation s "shal l require " th e submissio n of requisit e informatio n withi n th e prescribe d time frame, an d th e legislativ e histor y o f

sectio n 211(e ) suggest s tha t

i f th e requisit e informatio n i s no t submitte dwithi n thre e year s for registere dfuel s an dadditive s th e Agency' s regulation s "shoul dprovid e tha t suc h .registratio n shal l b e deeme d t o b e revoked"

. RR

. Rep t

No

. 95-284,95th Cong. , le t Sess

. 30 8 (1877) , Thi s provisio n ca n b e viewe da s authorizin gP

. 1 2



# w
r regulation s tha t provid e for

revocatio n whe n th e requisit e Informatio n i s no t provided

. K

th e regulation s provid e fo r revocatio n o f

th e registration , EP

A invite s commen t

o n th e procedura l safeguard s tha t

shoul db e provide dan d o n whethe r

an y administrativ e procedure s shoul db e afforde d i n advanc e befor e an y registratio n fo r a n existin g fuel o r

additiv e i s considere d revoked

. Lastiy , EP

A invite s commen t

o n th e consequence s dia t

shoul d follow whe n th e produce r

of a n unregistere d fue

l o r fuel additiv e submit s al l th e tes t dat a an d othe r requisit e informatio n require d for registratio n bu t

th e informatio n submitte d indicate s tha t

th e fue l o r additiv e pose s a n unreasonabl e risk t o th e pubh c healt h o r

welfar e o r

t o a n emissio n contro l system

. On e possibilit y i s f o vie w sectio n 211(b ) a s implicitl y authorizin g denia l o

f registratio n whe n a n unacceptabl e risk

i s shown

. Anothe r alternativ e i s t o vie w sectio n 211(b ) solel y a s a n information-gatherin g provisio n wit h sectio n 211(c ) governin g risk-base d regulator y actions

. Unde r thi s approach , th e procedure s an d criteri ao f sectio n 211(c ) woul d hav e t o b e use d i f th e Agenc y wishe dt o den y registratio n base d o n natur e o

f th e risks show n b y - th e tests o r

informatio n submitte d fo r registration

. I

f sectio n 211(c ) i s th e basi s for regulatin g arisk, ma

y th e Agenc y den y registratio n whil e apropose d regulatio n unde r

sectio n 211(c ) i s pendin g whic h woul dprohibi t o r limi t th e us e o f th e fuel o r

additive ? V

. Possibl e Progra mProtocol s A Health Effects Th e requirements an d tes t protocol s i n th e healt h effect s programmus t b e coordinate d an dstructured f o yiel d th e informatio n neede d t o determin e whethe r o r no t th e produc t

may caus e th e healt h effect s of

concern
. Thi s include s acollectio n o

f currentl y availabl e healt h effect s an d othe r informatio n neede d t o asses s risk a s wel l a s th e generatio n o

f additiona l healt h effect s dat athroug h testin g whe n th e presentl y availabl e dat ai s insufficien t

Th e overal l structur e ca n follo w amatri x o r

tiered forma

t o r a combinatio n of

both

. A matri x woul d b e ase t o f requirement s o

f whic h al l woul d nee d t o b e completed

. Tier s woul d b e se t u p 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 dprio r t o th e highe r levels

. Th e healt h effect s programbein g considere d b y EP

A combine s feature s o

f bot h amatri x an dtiered forma t I t woul d b e se t

u p with variou s tiers , an d withi n som e tier s ther e woul d b e ase t o r matri x o

f test s and/o r

othe r requirements ma t

woul dhav e to b e completed

. Fuels/additive s woul d hav e to sequentiall y complet e on e o r more tiers dependin g o n th e findings in eac h tier. Thi s progra

mwoul d b e formulate d suc h tha t producer s woul donl y hav e f o complet e th e tiers neede d f o gathe r th e healt h effect s informatio n require dfor decisio n making , withou t

havin g t o subjec t eac h fuel/additiv e to a predetermine dful

l arra y o f test s tha t ma y b e unnecessary an dprohibitivel y costly

. Th e health effect s progra mbein g considere d b y EP

A woul dconsis t

o f four tiers an d amatri x o r

se t o f requirement s withi n eac h tier. I t

woul d b e designe dt o b e a s self-implementin g a s possible

. Eac h o f thes e i s discusse dbelow

. A n explanatio n o f

th e first tier require s th e developmen t

o f concept s involvin g "bas e fuels " (withou t direc t additives) , "bas e additives" , an d thei r potentia l health effects

. Firs t to qualif y a s abas e fuel/additive , ther e woul d hav e t o b e adequat e existin g healt h effect s testin g informatio n t o determin e potential pubh c healt h effect s fo r regulatory decisio n making

. (EP A specificall y request s comment o n whethe r adequat e healt h effect s testin g informatio n currentl y exist s f o qualif y an y particular

fuel/additiv e a s a"bas e fuel/additive " a t

thi s time and

. if

no t request s specifi c recommendation s a s t o wha t additiona l informatio n i s neede d fo r acandidat e fuel/additiv e t o qualify

. A s note dabove , EP

A ha s include di n Docke t No

. A-SO-0

7 alis t o f man y o f th e publishe dreports o n existin g fuels. ) Second , EP

A woul dsee k

t o develo p definitions/specification s fo r bas e fuels / additive s suc h tha t

an y fuel/additiv e whic h woul dmee t

th e specificatio n fo

r a give n bas e fuel/additiv e woul d hav e essentiall y th e sam e potential publi c healt h effects

. Comment s ar e invite do n th e criteri ato b e used

. Thus , th e first tier woul d involv e th e basi c concep t of comparin g othe r

fuel s an d additive s seekin g registratio n unde r sectio n 211(b)(2) to th e specification s EP A woul d develo p fo

r bas e fuels/additives

. Existin g fuel s an dadditive s coul dals o see k t o sho w b y suitabl e informatio n tha t the y meet

appropriat e specification s fo

r th e bas e fuel/additive

. Assumin g bas e fuel s additive s ar e identified , th e fuels/additive s whic h confor mt o appropriat e specification s of bas e fuels/additive s woul dno t b e require d t o underg o further healt h effect s testin g unles s ne w concern s aris e i n th e future

. Thus , th e basi c tier 1 requirement woul dinvolv e reporting o f informatio n includin g physico/chemica l properties , productio n volume , concentratio n i n use , an dchemica l composif.es

. an d structur e activit y relationship , i

f needed , for

eac h fue l o r additive

. Producer s wh o believ e tha t thei r fuels/additive s woul d mee t th e specification s for

on e of th e bas e fuels/additive s woul dsubmi t dat aan d othe r analysi s calle d fo

r i n th e regulation s providin g justificatio n fo r thei r view

. N o further

healt h effect s testing woul d b e require d fo r thos e fuels/additive s found t o mee t th e specification s for abas e fuel/additiv e fo r suc h testin g woul db e duplicativ e o f adequat e existin g data

. Fo r thos e fuels / additive s found no t

f o fal l withi n th e specification s fo

r abas e fuel/additive , th e presumptio n woul db e tha t EP A doe s no t no w hav e sufficien

t informatio n fo

r regulatos y decisio n makin g an d th e fuel/additiv e woul d hav e to procee d to tier

2

. Th e goa l o

f th e tier 2 requirement s - woul db e th e collectio n an d submissio n of existin g health effect s informatio n fo r th e fuels/additive s i n question

. It woul d require th e produce r

t o conduc t

a thoroug h literatur e searc h (publi c an d in-house ) fo

r physico/chemica l information , health effect s studies , analyses , dat aan dan y othe r relevan t informatio n relate dto bot h th e ra w fuel / vapor , combustio n products , an d possibl y atmospheri c transformatio n product s o

f di e fuel/additive

. Thi s woul d cove r

informatio n o n al l of

th e huma n healt h effect s o

f interes t includin g bu t

no t limite d t o carcinogenicity , mutagenicity , teratogenicit y a s wel l a s othe r acute , subchroni c an d chroni c effect s discusse dpreviousl y i n thi s notice

. A s par t o f th e rulemakin g EP

A wil l nee d t o more specificall y defin e wha t healt h effec t endpoint s mus t

b e assesse d beyon d thos e specifie d i n sectio n 211(b)(2)(A)

. A s par t

of thi s tier, a

. produce r woul dmake an y request for a finding unde r

sectio n 211(e)(3)(C ) tha t additiona l testing o

f th e particula r

fuel/ additiv e woul db e duplicativ e o f adequat e existin g testing

. - I f healt h effect s informatio n i s supplie dt o addres s al l o

f th e healt h effect s endpoint s identifie d in tie r 2 , th e fuel/additiv e woul dno t

b e required t o ente r tie r 3

. I f relevan t gaps exis t

i n th e healt h effect s informatio n submitted , the n th e fuel/additiv e woul d b e require d t o ente r tie r 3

. It i s i n tier 3 wher e producer s woul db e required to conduc t an y neede d short

- o r

medium-ter

m healt h effect s tests

. I

f th e informatio n fro mtier s 2 an d 3 sho w apossibl e healt h effect s concern an d more definitive/extensiv e healt h effect s testin g ha s no t

bee n conducted , the n th e fuel/additiv e woul db e requiredt o procee dt o tie r

4

.

SE
-P.1 3

32228 Federa l Registe r / Vol . 55 , No . 15 2 /

Tuesday , Augus t7 , 199 0 / Propose d Rule s
Tier 3 requirement

s woul d involv e short
- and medium-ter

m healt h effects testin g (eg. , screening , acut e and subchronic)
. Depending o n the natur e o f the healt h effects informatio

n availabl e fro m tier 2
. the testin g in tier 3 coul d b e quit e comprehensive o r limite d onl y t o the gap s unfille

d i n tier 2
. Tie

r 3 test s woul d likel y includ e test s fo r physico / chemica l properties , a

n Ame s test , other geneti c toxicit

y tests , screenin g inhalatio n studie s a s wel l a s an y acut e an d subchroni c studie s neede d i o determine potentia

l public healt

h effects.^PA request

s commen to n the nee d fo r ora l arid/o r derma

l vs . inhalatio n studies
. Healt

h effects covere d includ e pulmonar y toxicity , mutagenicity , carcinogenicity , and teratogenicit

y (or toxicological indicators thereof) , and other healt h hazards , if

appropriate
. O

f course , EP

A mustreserve th e rightt

o requir e specifi c o r additiona

l test s for eac h fuel/additiv e o n a case-by-cas e basis
. EP A woul d anticipate tha

tthes e teste coul d b e complete d withi n th e previousl y discusse d three-year tim e perio d fo r submitting requisite information
. Individua l fuel s and additive s woul d procee d into tie r 4 onl y i

f th e availabl e tie r 2 informatio

n o r tier 3 tes tresults v. er e suggestiv e o f

a n unresolved , ye t potentiall y significan thealt h effects concern . Conceptually , tier 4 test s woul d b e follow-up long-ter

m tests for carcinogenicity , mutagenicity , and teratogenicit

y (and othe r endpoints)
. an d coul d involv e chroni c inhalatio n and/o r feedin g studie s amon g others . Test a woul d b e structure

d t o provid e adequat e toxicological information for makin g ris k assessments . Again , raw , combustion , an d possibl y atmospheri c transformatio

n product s coul d b e included
. EP

A invite s comment

s o n th e criteria tha

tshoul d b e include d i n th e guideline s and th e proces s tha tshoul d b e use d for makin

g indiviuda

l determination s and developin g appropriat

e procedures . EPA i s considerin g adopting man y o f th e tests o f th e TSC A Healt h Effect s Testin g Guideline s (40 CF

Rpar t798) a s guideline s unde r tiers 3 an d 4 an d ask s feu * commen ti n thi s area . That , tie r S an d 4 testin g requirement s woul d appl y primaril

y t o fuel s an d additive s fo r whic h ther

e i s insufficient information o r where th e availabl e informatio

n suggests tha

tth e substanc e ma y pos e a n unreasonabl e risk o f injur y t o huma n health . Fo

r example , ther e are a numbe r o f curren taftermarke

tfuel additive s far whic h there i s Util e pubfid y availabl e healt

h effecte information , an d futur

e alternativ e fuel s an d thei r additive s coul d als o b e subject t o testin g i f adequat e informatio

n doe s notexis tbase d o n tiers 1 an d 2
. Dependin g upo

n adequacy o

f existin g test s and di e specification s fo r bas e fuels/additives , thi s approac h t o healt h effects testin g coul d substantiall y reduc e th e numbe

r o f fuels/additive s potentiall y subjec

tt o furthe r testing
. The fou r tier progra

m describe d abov e ha s several inheren

tadvantages . First

, it i s a flexibl e approac

h whic h focuse s o n availabl e informatio

n regardin

g healt h effects withoutrequirin

g arbitrar y testing
. Second , the tiered approac h insure s tha

tneede d testin g will b e accomplished
. Third, overall progra m cos ti s reduce

d unde r the tie r approach . And , finally, the matri

x forma tse tu p withi n each tier help s scree n fals e negativ e and yiel d mor

e confiden

t results . Sectio n 211(b)(2)(A ) clearly indicate s tha tcarcinogenicity , mutagenicity , and teratogenicit

y i s t o b e assessed . However , EP

A i s allowe d some judgmen ti n detenmhin g wha

tother healt h effects endpoint

s should b e included
. EP

A ask s commen

to n what othe r healt

h effects endpoint

s shoul d b e include d a s mandatory , whic h shoul d b e applie d o n a n individua

l basis , an d throug h wha tprocedur

e thes e determinations shoul d b e made . Overall , thi s progra

m approac

h i s intended to : (1 ) Provide a n efficientmean s o

f identifying and summarizin

g th e existin g information o n th e healt

h effect s o f fuel s an d additives , (2 ) identifyin g th e information gaps , an d (3 ) generating th e ne w information neede d for regulator y decisio n making
. B. Effects on Emission Control Systems I n additio n t o a progra

m fo r healt h effects , th e Ac tals o require s di e producers/manufacturer

s t o provid e th e information tha

ti s "reasonabl e and necessary " t

o determine th e emission s resultin g from a fuel o r fue l additiv e an d th e effecto f

such a fue

l o r fue l additiv e o n th e emissio n control performanc e o f any vehicl e o r engine
. Th e potentia l scop e coul d includ e emissio n specdatit m fo r regulated and unregulate d pollutant

s a s wel l a s effects o n initial emissio n rates , emissio n deterioratio n rates , maintenanc e reqwreraenta, system longevity , and materials
. Other concern s coul d includ e overal l genera l effects o n th e vehicle/engin e and emissio n control syste m performance
. EP

A invite s comment s o n th e exten tt o whic

h informatio

n i s neede d o n thes e effects
. EP A i s contemplatin g a progra m desig n simila r t o tha

tdiscusse d previousl y fo r healt

h effects and woul d agai n primaril

y utiliz e a tiere d approac

h with a matri

x e f requirements i n aome tiers. Th e principle s discusse d earne r regardin g bas e fuels/additive s woul d als o apply here . EP

A doe s notanticipat e a needlessl y broad testin g program, but woul d striv e t

o limitan y information reporting o

r testin g t o onl y thos e fuels / additive s wher e information i s neede d fo r regulatory decisio n makin g o r concern s exis tove r risks t o th e emissio n contro l syste m performance
. Th e tiers envisione d fo

r determining emissio n control syste m effects ar

e discusse d individuall y below . A s wit h tie r 1 unde

r th e healt

h effects program , thi s initia

l tie r woul d involv e th e us e of th e bas e fuels/additive s concep tand a showin g b y th e producers tha tthei r fuels/additive s fal l withi n th e . specification s of

on e of tb e bas e fuels / additives
. Lik

e unde r th e healt

h effects program , fo r a fue l o r additiv e t

o b e specifie d a s a bas e fuel/additive , adequate existin g information mustb e availabl e o n th e emissio n contro l syste m effects o f th e fuel/additiv e fo r regulator y decisio n making
. Assumin g bas e fuels/additive s are identified , fuels/additive s whic h mee tth e specification s o f

a bas e fuel/additiv e woul d b e exemp tfrom testin g unles s ne w informatio n need s arise
. Thos e product s whic h d o notfal l unde r on e o f th e bas e fuels/additive s woul d b e required t o ente r tie r 2
. since th e presumption woul d b e thatEP A doe s no tno w hav e sufficientinformatio n o n thos e product

s far regulator

y decisio n making
. A s wit h th e healt

h effect s program . EP A ask s commento n whethe r adequate emissio n control syste m effect s informatio n currently exist s t o qualif y an y particular fuel/additiv e a s a "bas e fuel/additive " a tthi s tim e and , i f no trequests recommendations a s t o wha tadditional information i s neede d fo r a candidate fuel/additiv e t o qualify
. Tie r 2 woul d requir

e th e produce r t o submitwhateve r additional informatio n i s presentl y availabl e o n th e emission s o r emissio n contro l syste m impact s fo r th e fuel/additiv e unde r consideration
. Thi s woul d includ e a literature searc h for publi c an d in-hous e engineerin g studies , analyses , an d dat a aime d a t determinin g whethe r o r no tth e fue l o r additiv e showe d an y potentia l for advers e effect s i n th e area s of concer n discusse d above . I

f th e informatio n submitte d wa s sufficientn o testin g woul d b e required. If

, however , th e availabl e dat a wa s insufficien to r th e fue l o r additiv e showe d potentia l fo r causin g variou s undesirabl e effect s o n emissions , emissio n contro l syste m performance , o r tb e vehicle/engin e i n general , the n th e fuel/additiv e woul d hav e to ente r tier a.P..1 4 

## mi

••'•; < Fsdfflffffl l a®gist e /

Vol

. 55 , No

. 15 2 /

Tuesday , Augus t

7,199 0 /

Propose d Rule s



### 3



# 1 1 Requirements an d tests unde r tier 3 woul d b e focuse d o n assessin g specifi c concern s raise d i n tier

2 , o r jus t o n supplyin g th e informatio n lackin g fro m th e tie r 2 requirement

Thi s tier coul d involv e an y combinatio n o r for mo f vehicle/engin e test s t o provid e th e neede d information , bu t

EP A woul 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 submittin g requisit e information

. EP A invite s commen t

o n ho w thi s progra mshoul d b e implemente d an d wha t testing an d othe r

informatio n shoul d b e considere d reasonabl e an d necessary
. EP

A als 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. Determination of

Welfare Impacts Unde r sectio n 211(e) , th e Agenc y i s t o issu e regulation s tha t

wil l implement

it s authorit y regardin g th e assessmen t o f welfar e effects

. CA A subsectio n 211(b)(2)(B ) state s tha t

th e Administrato r

ma y requir 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 h emission s of

fuel s an d additive s affec t

th e publi c health o r welfare

. Th e welfar e effect s potentiall y includ e al l aspect s of

ecology

. Thi s assessmen t

coul d tak e int o consideratio n th e emissions ' residence time i n th e air , th e fat e o

f th e pollutant , an d wha t reaction s occu r

with othe r pollutant s i n th e air , includin g atmospheri c transformatio n products / byproduct s an d depositio n effects

. Th e Agenc y i s considerin g usin g a tiered approac h lik e tha t

discusse d abov e i n determinin g welfar e effects

. Fuels/additive s t o b e registere d unde r sectio n 211(b)(2 ) woul d b e compare d wit h specification s EP

A woul d develo p for "bas e fuels/additives. " Again

. EP A request s commen t

o n whethe r

adequat e reasonabl e an d necessar y informatio n exist s o n welfar e effect s t o qualif y an y particula r fuel/additiv e a s abas e fuel/ additiv e a t

thi s time and , i

f no t requests specifi c recommendations 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 to submi t informatio n t o sho w tha t

thei r fuel / additiv e meet s di e specification s define d fo

r bas e fuels/additives

. I

f n o fuels/additive s qualifyin g a s "bas e fuels/additives " ar e determine d o r i f thi s informatio n di d no t

sho w th e fuel

/ additiv e to b e essentiall y th e sam e a s a bas e fuel/additive , the n further reportin g requirement s woul d b e necessary
. Lik

e tier 2 discusse dearlier , thi s woul d involv e athoroug h hteratur e searc h fo r existin g informatio n an d dat a o n know n welfar e effects

. I n submittin g information , producer s coul d b e required t o report th e know n welfar e effect s o f th e raw , combustion , an d atmospheri c transformatio n product s o f fuel s an dadditives

. Suc h informatio n coul db e obtaine d fro

mstudies , literatur e searches , reports , summarie s o f existin g dat aan dinformation , an d othe r readil y availabl e discussio n concernin g th e assessmen t o f welfar e effect s associate dwit

h th e use / combustio n o

f fuel s an dfuel/additives

. Thi s informatio n coul d the n b e use d t o determin e whethe r

o r no t th e produc t pose s asignificant

hazar d to welfar e o r th e environment

. I

f apotentiall y seriou s welfare threa t

exists , base d o n criteri a establishe d i n thi s rulemakin g fo r makin g suc h adetermination , the n further studies , whic h coul db e include d a s tie r 3 and/o r 4 , ma y b e requiredo r appropriat e regulator

y actio n taken

. EP A request s comment s o n thi s approac h an do n the exten t to whic h th e welfar e effect s shoul db e assesse d throug h th e submissio n o

f informatio n o r throug h specifi c testin g requirements. Th e Agenc y welcome s suggestion s regardin g othe r

appropriat e mean s of assessin g welfar e effects

. EP A als o ask s comment o n th e applicability o

f th e TSCA Environmental Effect s Testin g Guideline s (4

0 CF Rpar t 797 ) t o thi s requiremen t V L Statutory Authority Authorit y fo r th e action s propose di n thi s notic e i s grante d t o EP A b y section s 21 1 an d 301(a

) o f th e Clea n Ai r

Ac t a s amende d(4

2 U.S.C

. 7521(a) , 7525 , an d 7601(a) ; Pubh c La

w 95-95)

. VU

. Administrativ e Designatio n an d Regulator y Analysi s Executiv e Orde r

1229 1 state s tha t

a n Agenc y mus t

judg e i f arulemakin g woul d b e "major"

. A rulemakin g i s considere d"major " i

f i t wil l hav e a n annua l effect

o n th e economy o

f $100 millio n o r more , i f ther e wil l b e amajo r cos t increas e fo

r consumers , individua l industries , federal , state , o r loca l government

agencies , o r

othe r geographi c regions, an d i

f ther e wil l b e significant advers e effect s o n competition , employment , investment , productivity , innovation , o r o n th e ability o f U.S.-base d enterprise s t o compet e with foreign-base denterprise s i n domesti c o r

export markets

. A t

thi s juncture , i t

ha s no t bee n determine di

f thi s actio n represents amajo r rulemaking

. Vffl

. Publi c Participatio n T o ai di n preparin g th e propose drule , EP A encourage s ful

l pubh c participatio n i n thi s aciton

. Comment s ar e requeste d o n al l aspect s of

th e suggeste d program an d fro mal l intereste d parties

. I

f possible , comment s shoul db e

accompanie d b y ful

l supportin g dat a (includin g productio n volume dat aan d complet e chemica

l compositio n data ) an dadetaile d analysis

. Partie s ar e encourage d to submi t

informatio n whic h ma y no t b e detaile din th e curren t registration dat abas e a s EP A wil l b e usin g wha t

informatio n i s presen t

i n supportin g analyse s fo

r th e NPRM

. Du e t o th e time elapsed , EP

A i s no t considerin g comment s submitte d t o Docke t ORD-78-0 1 fo

r th e 197 8 ANPR

M unles s the y ar e resubmitte d t o Docke t A-S0-0 7 fo

r thi s curren t

rulemaking

. Comment s containin g proprietar y informatio n shoul db e sen t t o th e contac t perso n liste dabove ; however , a non-confidential versio n shoul db e sen t t o th e pubh c docke t

i f th e informatio n i s intende dt o b e considere d b y EP A i n developmen t

o f th e NPRM

. Informatio n covere d b y aclai mo

f confidentiality wil l b e disclose d b y EP

A onl y f o th e exten t allowe d an d b y di e procedure s se t fort h in 4 0 CF RPar t 2

. I f n o claim s of confidentiality accompanie s th e submissio n whe n i t

i s received b y EP A i t ma y b e mad e availabl e t o di e pubh c withou t furthe r notic e t o th e commenter

. EP A desire s specifi c comment s o n th e followin g additiona l issue s regardin g thi s rule : 1

. Healt h Effects
a
. Shoul dEP

A develo p tes t

guideline s or , mor e specifically , tes t

plan s fo r purpose s o

f determinin g healt h effects ? b

. I n th e even t

tha t EP A establishe s mor e tha n on e testin g plan , shoul d th e tes t pla n selecte dreceive prio r EP A approval ? aHo w shoul dth e tes t

pla n b e organized , tie r

o r matrix ? d

. Fo r th e fou r tiers suggeste di n thi s notice , what

shoul d th e requirements be ? e
. Wha t othe r healt h effects , 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 a n acceptabl e test ? h

. Wha t shoul d b e th e criteri afor determinin g positiv e an dnegativ e tes t results ? i

. Ho w shoul dth e pollutant s b e administere d to th e hos t

bein g teste d (rout e o f exposure) ? j

. Wha t i s th e mos t

appropriat e groupin g schem e fo

r fuel s an d additive s an d wha t criteri ashoul d b e use d t o designat e fuel s an d additive s int o prope r categories ? k

. Ho w shoul d representative fuel s o r additive s fro

mwithi n eac h grou p b e selected ?P.1 5

3223 0 Federa l Registe r / Vol . 55 , No . 15 2 /

Tuesday , Augus t7,199 0 / Propose d Rule s
1
. Wha tcriteria shoul d b e use d t o excus e a fue

l o r additiv e fro

m additiona

l testin g base d o n availabl e information ? m . Ho w shoul d fue

l and additiv e manufacturer

s submittes tdata ? n . O n wha tbasi s o r leve l o f risk shoul d a control b e establishe d fo r a fue l o r additive ? o . Ho w coul d existin g guideline s (TSCA , FIFRA

, OECD, EPA

) be app!ie

d i n thi s rulemaking ? 2
. Emission s Effect

s Testin g a. Shoul d EP

A develo p tes tguideline s or , mor e specifically , specif

y tes tplans fo r purpose s of

determining emissio n contro l syste m effects ? b . I n th e even ttha

tEP A establishe s mor e tha n on e testin g plan , should the tes tplan selecte d for us e b y the producer receiv e prio r EPA approval ? a Ho w shoul d a progra

m b e structured for assessin g tb e effects o f a fue l oradditiv e o n emissio n contro l syste m performance ? d . Whattest s shoul d b e included ? e . Wha tconstitute s a n acceptabl e test ? f
. Wha tcriteri a shoul d b e use d t o decid e if th e tes ti s positiv e o r negative ? h . Ar e ther e an y existin g tes tplan s o r procedure s for assessin g th e performanc e o f emissio n control system s tha

tshoul d b e use d in thi s program ? i
. Wha tprocedures shoul d b e use d fo r sampling unregulated emissions ? j
. Wha tportion o f

th e exhaus tshoul d b e collecte d and measured (i.e., whol e exhaust , fractionate d exhaus tirradiated whol e o r fractionate d samples) ? k . Wha tdriving cycle s shoul d b e par t of a testin g program ? 1
. Ho w man y mile s shoul d a

n engine/ vehicl e b e driven fo

r each tier o

f testing ? m . Should evaporativ e and refueling emission s b e sampled ? n . Should runnin

g losse s b e sampled ? o . How shoul d manufacturer s submi t tes tdata ? p . O n whatbasi s shall fuel s and additive s b e controlle d o

r banned ? 3
. Othe r Matters a. Wha twelfare effects shoul d b e assesse d an

d ho w shoul d dii s b e accomplished ? b . Beside s grouping fuel s and additive s tha

tar e essentiall y th

e same , whatothe r mean s ar

e ther e for minimizing duplicativ e testing ? c . Wha tmeasure s shoul d b e implemented t o allo w for cost - and/o r burden-sharing betwee n manufacturers ? d . Wha tcriteria shook ] 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 and sale s level s are use d t o define smal

tbusiness , whatlevel s shoul d thes e b e se tat ? f
. Shoul d a manufacturer b e excuse d fro m healt h effects and emissio n testin g where itca

n demonstrate thatth e fuel o r fue l additiv e i

n questio n wil l notcaus e a n advers e healt

h effec to r affect emissio n contro

l devic e performance ? I

f so , wha tshoul d EP

A requir e fro m the manufacture

r t o mak e such a showing ? Should EP A develo p screenin g tes t requirement

s a s par tof thi s rulemaking a s outliend eariier ? g . Wha tfactors shoul d b e include d i n an y enforcemen

tprogram ? Lis tof Subjects in 4 0 CF

RPar t7 9 Administrativ e practice s an d procedures , Diesel , Diese l additives
. Emission contro l systems . Fue l Fue l - additives , Gasohne
. Gasolin e additives
. Healt h and welfar e effects
. Moto r vehicl e pollution
. Penalties
. Dated : Augus

tt , 1990
. VVUlia m K . Reilly , Administrator. (F RDoc . 90-1845 2 File d 8-6-80 ; 8:4

5 am )
BILLIN G COO E 6S6O-S0- M 

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