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# OAR Box 1165 Prepped by Ollie Stewart



## Document

Number: 

# 253 ) F. RApri

l 15 , Docket Number: 

# A-90-0 7

Printed 4/28/200811:52:23 AM 

# 199 2

Sheet 253 of 257P. 2 

# A-qO-Of
Wednesda

y Apri l 15 , 1992



# Par t I I 

# Environmenta l Protectio n Agenc y

s 4 0 CF R Par t 7 9 Fuel s an d Fue l Additive s Registratio n Regulations : Propose d Rul e1316 8 Federa l Registe r /'Vol

. 57 , No.

- 7 3 /

Wednesday ; Apri l 15 , 1992 , / Proposed-Rule s P. 3

ENVIRONMENTA L PROTECTIO N AGENC Y 4 0 CF R Par t 7 9 [FRL-4121-4 ] Fuel s an d Fue l Additive s Registratio n Regulation s AGENCY : Environmenta l Protectio n Agenc y (EPA)

. ACTION : Notic e of

propose drulemakin g (NPRM)

. SUMMARY

: Thi s notic e present s propose dregulation s fo

r th e registratio n of moto r vehicl e fuel s an dfuel additive s a s authorizedb y section s 211(b)(2 ) an d 211(e) o f th e Clea n Ai r

Ac t (CAA)

. Unde r di e propose dregulations , producer s of

moto r vehicl e fuel s an d fuel additive s woul db e require dt o conduc t certai n test s an dsubmi t informatio n regardin g th e compositio n of emission s produce db y suc h fuel s an d fuel additive s an dth e effect s o f thes e emission s o n th e publi c healt h an d welfare

. Additiona l provision s fo r determinin g th e effect s o

f fuel s an d additive s o n th e performanc e o f vehicular emissio n contro l device s woul db e coordinate dwith existin g an d future rule s unde r

sectio n 211(f)

. Th e proposa l include s agroupin g syste man d othe r mechanism s designe dt o avoi d duplicativ e effort s an dreduc e th e cost s of testin g b y producer s o

f fuel s an dfue

l additives

. ; Th e propose dregulation s woul d supplemen t

existin g registratio n requirements , an dwoul dpotentiall y appl y t o bot h curren t

an dfuture fuel s an dadditives

. Th e propose dne w requirement s ar e designe dt o provid e a bod y o f informatio n tha t

woul dassis t EP A i n evaluatin g di e potentia l advers e effect s o f variou s type s o

f fuel s an dfue

l additive s an di n determinin g whethe r futher risk assessmen t

o r regulator y actio n i s neede dunde r

sectio n 211(c)

. DATES : Writte n comment s o n thi s Notic e o f Propose dRulemakin g (NPRM) wil l b e accepte dunti l Jun e 30,1992

. A publi c hearin g wil l b e hel dMa

y 28,199 2 a t

9 a.m
. It wil l b e extende dt o Ma

y 29 , i f necessary , bu t

prospectiv e presenter s shoul db e prepare dt o testif y o n th e firs t day

. ADDRESSES : Comment s o n th e NPR M shoul db e submitte di n duplicat e to : EP A Ai r Docke t (LE-131) : Attention : Docke t No

. A-90-07 ; U.S

. Environmenta l Protectio n Agency , roo mM-1500 , 40 1 M Stree t SW. , Washington , D C 20460 ; phon e (202

) 382-7548

. Thi s docke t

i s locate da t th e abov e addres s o n th e firs t floo r o f Watersid e Mal l an di s ope n fo r publi c inspectio n weekday s fro m8:3 0 a.m
. t o 1 2 noo n an dfro m1:3 0 p.m
. t o - 3:3 0 p.m
. A s provide di n 4 0 CF Rpar t 2 , a reasonabl e fee ma y b e chargedb y EP A fo r copyin g services

. Th e publi c hearin g wil l b e hel di n An n Arbor , Michigan a t th e An n Arbo r

Regent—Bes t

Wester n Domino' s Farm s Hote l an dConferenc e Center

. 3600 Plymout

h Roa d(U.S

. 2 3 a t Plymout h Road) ; phon e (313 ) 769-9800

. FO RFURTHE

RINFORMATIO

N CONTACT : Mrs

. Caroly n Krueger , SDSB12 , Regulatio n Developmen t

an dSuppor t Division , U.S

. Environmenta l Protectio n Agency , 256 5 Plymout

h Road , An n Arbor , M I 48105 ; phon e (313 ) 668^274

. Person s wh o wis h t o receiv e acop y o f th e regulator y tex t

fo r thi s propose drul e (includin g th e propose dheald i testin g guidelines ) shoul dleav e amessage , includin g thei r

name , complet e mailin g address , an dtelephon e number , a t (313 ) 668-4361

. Th e propose dregulator y tex t i s als o availabl e i n th e publi c docke t reference dabove

. SUPPLEMENTAR

Y INFORMATION : I

. Publi c Hearin g An y perso n intereste di n presentin g testimon y a t

di e publi c hearin g shoul d notif y th e contac t

perso n liste dabov e a t leas t seve n day s prio r

t o th e da y o

f th e hearing

. Th e notificatio n shoul dinclud e th e estimate dtim e require dfo r th e presentatio n an didentification of audio / visua l equipmen t

needs , if any
. A sign

u p shee t wil l b e availabl e a t

th e registratio n tabl e th e mornin g of th e hearin g fo

r schedulin g th e orde r

o f testimony

. I t

i s suggeste dtha t

sufficien t copie s o f th e statemen t

an dothe r presentatio n material s b e brough t t o th e hearin g for

distributio n t o th e audience

. Al l material s submitte dwil l b e mad e par t o f th e officia

l recor dfo

r thi s rulemaking

. Mr

. Richar dD

. Wilson , Directo r of di e Offic e o f Mobil e Sources , ha s bee n designate da s presidin g office r for th e hearing

. Th e hearin g will b e conducte d informally , an dtechnica l rule s o f evidenc e wil l no t

apply

. Writte n transcript s o

f th e proceeding s wil l b e mad e b y acourt

reporter

. Copie s will b e availabl e fo

r examinatio n i n th e publi c docke t o r fo r purchas e b y individua l arrangemen t

with th e court

reporter

. II

. Backgroun d A. Introduction Ove r 2,20 0 fuel s an d4,100 fuel additive s ar e currentl y registere dwith EP A and , t o som e degree , eac h o f the m
. produce s emission s whic h ma y contribut e t o potentiall y harmfu l ai r pollutio n i n th e Unite dStates

. Th e primary purpos e o

f thi s propose d rulemakin g i s t o establis h registratio n requirement s whic h wil l provid e informatio n fo r identifyin g an d evaluatin g th e potentia l advers e ai r pollutio n effect s o

f moto r vehicl e fuel s an dfuel additive s an dfo r guidin g th e directio n o

f relate dregulator y action s in th e future

. Th e remainde r

of thi s sectio n review s th e statutor y histor y of

thi s propose d rulemaking , summarize s th e publi c comment s receive di n respons e t o th e Advance dNotic e o

f Propose d Rulemaking , an ddefine s certai n ke y term s use di n late r

discussion

. Th e overal l scop e o

f th e progra mi s describe di n sectio n III

. Sectio n I V outline s th e objectives , rationale , an d implementatio n o

f th e propose d groupin g syste mfo

r fuel s an dadditives

. Issue s german e t o th e generatio n o f fuel/additiv e emission s fo r subsequen t testin g ar e discusse di n sectio n V , an d propose drequirement s fo r evaluatin g th e effect s o

f fuel s an dadditive s o n th e publi c healt h an dwelfar e ar e describe d i n sectio n VI

. Sectio n VI

I outline s th e propose dreportin g requirement s fo r th e program
. Subsequen t

section s discus s specia l progra mprovisions , complianc e considerations , confidentialit y issues , publi c participation , an dadministrativ e topics

. B. Statutory History Sectio n 211(a

) o f th e Clean Ai r

Ac t (CAA)

. 4 2 U.S.C

. 7545

. authorize s EP A t o designat e an y moto r

vehicl e fue

l o r additiv e an dprohibit s producer s o f designate dfuel s o r

additive s fro

m sellin g suc h product s unles s the y hav e bee n registere db y EP

A i n accordanc e with sectio n 211(b)

. Th e basi c dat a element s whic h producer s of fuel s an d additive s mus t

submi t fo r purpose s o

f registration , a s stipulate db y sectio n 211(b)(1)

. includ e commercia l identifyin g information , rang e of

concentration , purpose-in-use , an dchemica l comppstion

. EP

A issue dregulation s implementin g thi s provisio n i n 197 5 (40 CF Rpar t 79)

. Th e 197 0 CAA als o provide dEP A wit h discretionar y authorit y t o establis h additiona l requirement s fo r fue l an dfue l additiv e registration

. Accordin g t o sectio n 211(b)(2) , EP

A "ma y als o require " producer s "t o conduc t test s t o determin e potentia l publi c healt h effect s o f suc h fuel[s ] o r

additive[s ] (including , bu t no t limite dto , carcinogenic , teratogenic , o r

mutageni c effects), " an d t o furnis h othe r

"reasonabl e an d necessary " informatio n t o identif y fue l an dfuel additiv e emission s an d determin e thei r

effect s o n vehicula r emissio n contro l performanc e an do n th e publi c healt h an dwelfare

. Th e statut e further

stipulate s tha t

testin g fo

r healt h effect s i s to b e conducte dP. 4

^Federa l Kegiste r

/ ; Vol.-57

. No l 73 '

/ Wednesday , Apri l 15 , 199 2 / fropbsed'Rales : 12il6 9
accordin g t o procedure s an dprotocol s establishe db y th e Administrator , an d tha t tes t result s will no t

b e considere d confidential

. Whe n di e produce r ha s submitte dth e require dinformatio n an d ha s give n assurance s dia t th e Agenc y wil l b e notifie do f

future change s i n tha t information , sectio n 211(b)(3 ) direct s tiie Administrato r

t o gran t registratio n t o th e fuel o r

additive

. EP A di dno t exercis e it s discretionar y authorit y t o requir e fuel an dadditiv e testin g unde r

sectio n 211(b)(2 ) whe n di e genera l registratio n regulation s unde r sectio n 211(b)(1 ) wer e issue di n 1975

. However , i n th e CA A Amendment s o f 197 7 (Pub

. L 95-95 , Augus t 7,1977) , Congres s adde dsectio n 211(e ) t o th e statute , whic h mad e implementatio n o f sectio n 211(b)(2 ) mandator y an d containe dadditiona l provision s concernin g th e implementatio n o f th e statute

. Sectio n 211(e)(1 ) require s implementatio n of

th e sectio n 211(b)(2 ) authorit y withi n on e yea r o f enactmen t of th e 197 7 amendments

. I n a n effor t t o fulfil l thi s requirement , EP

A publishe d a n Advance dNotic e of

Propose d Rulemakin g (ANPRM) i n 197 8 (se e 4 3 F R 38607 , Augus t

29,1978 ; Docke t

ORD-78

- 01) ; however , di e rulemakin g di dno t g o forwar ddurin g th e nex t

te n years
. Nevertheless , thi s actio n ha s remaine d o n th e EP A regulator y agenda , an da developmen t

pla n fo r th e rulemakin g wa s create di n 1988

. C. Recent Events and

Agency Actions I n 1989 , acitizen s grou p brough t a lawsui t {Thomas v. Reilly, CA

- No

. 89

- 626 9 [D

. Oreg

. 1989] ) challengin g EPA' s failur e t o promulgat e fuel an dfuel additiv e testin g regulation s widii n th e one-yea r tim e limi t

permitte db y CA A sectio n 211(e)

. EPA entere dint o a consen t decre e i n settlemen t

o f thi s lawsui t withou t adjudicatio n o f

an y issu e of fac t o r law

. Th e consen t

decree , whic h wa s signe db y tiie Court , require d tha t th e EP A Administrato r

sig n a n advanc e notic e of

propose drulemakin g b y Augus t

1,1990 , anotic e of

propose d rulemakin g b y Januar y 1,1992 , an da final rul e b y Jun e 1,1993

. Th e decre e di d no t addres s "th e substanc e of th e rulemaking, " no r

di di t "limi t 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 an y fashion"

. B y agreemen t

with th e plaintiff

, th e NPR M signatur e deadlin e wa s late r extende dt o Apri l 1,1992

. Th e Agenc y publishe dth e require d ANPR M o n Augus t

7.199 0 (5 5 F

R32218)

. A publi c hearin g wa s hel do n Septembe r 26,1990 , followe db y a30-day perio dfor writte n commentary

. Publi c repons e include dfou

r ora l presentation s a t

th e hearin g an dth e subsequen t submissio n of 2 4 writte n comments

. T o gai n furthe r

publi c involvemen t

i n th e rulemaking , th e Agenc y engage dth e service s o f

aprivat e consultan t

grou p t o asses s th e feasibilit y an d appropriatenes s of

applyin g regulator y negotiatio n procedure s (unde r th e provision s o f

sectio n 58 3 o f

th e Negotiate dRulemakin g Ac t of 1990 ) t o th e developmen t

of th e sectio n 21 1 regulations

. Durin g th e month s of Marc h an dApril , 1991 , th e consultant s interviewe drepresentative s of avariet y of affecte dindustr y group s an d environmenta l organization s t o gaug e thei r leve l o f interes t i n th e progra man d thei r willingnes s t o participat e i n potentia l negotiations

. Thes e partie s wer e als o invite dt o ameetin g i n Washington , D C o n Ma y 2,1991

. t o discus s th e progra missue s furthe r an d t o explor e th e potentia l advantage s an d disadvantage s of

aformal regulator y negotiatio n process
. Susbsequently , th e meetin g attendee s wer e polle dagai n abou t thei r willingnes s t o ente r negotiations

. Th e result s indicate dtha t ther e wa s insufficien t

suppor t amon g a numbe r of ke y parties , an dEP

A thu s decide dno t

t o conven e aregulator y negotiatio n fo

r thi s propose d rulemaking

. D. Summary and

Analysis of

Comments 1

. ProgramFocu s an dJurisdictiona l Issue s Th e overal l focu s an dscop e o f th e potentia l ne w registratio n requirement s wer e frequent

topic s of publi c commen t receive di n respons e t o th e ANPRM

. Wit h respec t

t o provision s i n sectio n 21 1 concernin g th e publi c healt h and

. welfar e impact s of

fuel s an dfuel additives , nearl y al l respondent s recognize dtha t

informatio n an dtestin g requirement s relate dt o fuel an d additiv e emission s wer e mandate db y th e statute

. However , no t al l respondent s agree dabou t th e propriety , necessity , an ddesirabilit y o f requirement s fo

r th e conduc t

of test s o n th e "raw " (i.e. , uncombuste dliquid ) fuel s an dadditive s themselves

. Th e majority maintaine dtha t th e underlyin g objective s o

f th e Clea n Ai r

Ac t an dth e specifi c languag e o

f sectio n 21 1 woul d bes t b e me t b y restrictin g th e focu s o f th e regulation s t o fue

l an dfue l additiv e emissions

. Accordin g t o thes e respondents , requirement s addressin g th e potentia l advers e effect s o f "raw " fuel s an dadditive s woul dno t hel p to elucidat e th e source s an deffect s o f ai r pollution , an dwoul dthus fal l outsid e th e scop e o

f th e statute

. A fe w commenter s hel dth e opposit e poin t o f view , arguin g fo

r broa dan d comprehensiv e healt h testin g of fuel s an dadditive s i n thei r

origina l liqui d formulation s a s wel l a s i n th e combuste dan dvaporize dstates

. A s discusse dmor e full

y i n sectio n III. B o f thi s NPRM , EP

A believe s tha t

th e Agenc y ha s som e discretio n unde r sectio n 21 1 t o determin e th e focu s of fuel an dadditiv e evaluatio n requirements

. Consisten t

wit h th e goal s o f

th e CAA , EP A ha s decide dt o focu s thi s propose d rulemakin g o n th e emissions-base d effect s of fuel s an dfuel additives

. Thus , th e propose dhealt h effect s testin g provision s specificall y addres s th e effect s o f inhalatio n exposur e t o fuel an dadditiv e emissions , inculdin g bot h evaporativ e an dcombustio n emissions

. Test s t o determin e th e direc t toxicit y of "raw " fuel s an dadditive s (e.g. , b y ora l o r derma l exposure ) ar e no t include d excep t insofar a s suc h informatio n ma y b e heede dt o determin e th e effect s o f thei r emissions

. Th e Agenc y believe s thi s focu s t o b e compatibl e wit h th e inten t o f Congres s an dth e scop e o f authorit y grante db y sectio n 211

. Focusin g today' s propose drulemakin g o n th e emission s o f

fuel s an dfuel additive s wil l als o serv e t o reliev e concern s abou t

possibl e area s o f overla p betwee n sectio n 21 1 an dothe r Federa l regulator y programs
. Existin g authorit y unde r

th e Toxi c Substance s Contro l Ac t

(TSCA)

. 1 5 US C sectio n 260 1 et seq., ha s ofte n bee n cite di n thi s regard

. TSC A provide s EP A authorit y to

. examin e th e potentia l environmenta l an dhealt h risks associate dwith chemica l substance s o r

mixtures , an d severa l respondent s fel t

tha t promulgatio n of

th e healt h effect s testin g provision s i n sectio n 211(b ) woul db e duplicativ e o f

th e regulator y mechanism s alread y i n effec t unde r TSCA

. Whil e rejectin g th e notio n tha t TSC A might

eliminat e th e nee dfo

r implementatio n of

sectio n 211(b) , EP

A recognize s th e nee dfo

r coordinatio n betwee n th e tw o programs
. T o alarg e extent , th e potentia l overla p betwee n TSC A an dsectio n 21 1 i s mor e legalisti c tha n programmatic , an dnee dno t

resul t i n overlappin g regulations

. Becaus e o

f th e technica l difficultie s associate dwith testin g comple x mixtures , th e TSC A progra m ha s traditionall y focuse do n th e toxicit y o f discret e chemcia l substance s rathe r tha n o n comple x mixture s suc h a s fuel s an dadditives

. I n fact , unde r th e Premanufacturin g Notificatio n proces s implemente dfo

r ne w chemica l review , TSC A exclude s chemica l mixture s excep t thos e whic h occu r

i n nature

. Moreover , unde r

bot h CA A an dTSC A programs , person s ma y submi t existin g dat at o fulfil

l regulator y requirement sP. 5

1317 0 Federa l Registe r/ Vol..$7 , No . 7 3 /

Wednesday , Apri l 15
. 199 2 / Propose d Rule s

and ar e notrequired t

o submit duplicativ e data . Nevertheless , som e individual chemical s use d i n fue l and additiv e formulations hav e bee n subject t o revie w and testin g unde rTSCA
. EPA' s pla n t o limitth e focu s o f sectio n 21 1 regulation s t

o emmissions-base d effect s wil l hel p t o avoi d th e possibility tha tsuch activitie s underTSC A migh t overlap with testin g requirement s promulgated unde rsectio n 211(b)
. Concern s abou tpotential regulator y overlap wer e als o raise d i n conjunctio n with th e mobil e source-relate d airtoxics provision s adde d b y th e 1990 CA A Amendments (CAA Sectio n 202(1))
. Sectio n 202(1 ) require s tha tEP A complete a stud y of

th e nee d foran d feasibility of

controllin g unregulate d toxi c ai rpollutants associate d wit h moto rvehicle s and fuels
. Base d o n thi s study , EP A mus tpromulgat

e vehicl e or fue l standard s t o control mobil e sourc e emission s of

benzen e an d formaldehyde
. A tEPA' s discretion , othe rtoxi c pollutants ma

y als o b e controlled . I n th e opinio n o

f som e respondents , EPA' s informationa

l objective s in regar

d t o th e ai rpollutio n effects o f fuel s and additive s woul d b e bette rserve d b y th e ai rtoxic s provision s o

f sectio n 202(1 } tha n b y th e healt

h and environmenta

l provision s o

f sectio n 211(b)
. Accordin g t o thi s view , sectio n 202(1) mandate s a mor e directapproach , focusin g o n specifi c mobil e sourc e ai rpollutants whic h represen tdi e greates tris k t o huma n healt h an d requiring th e identificatio n o

f currentl y unregulated mobil e sourc e pollutants whic h shoul d b e subjec tt o control . Whil e acknowledgin g tha tth e tw o part s of th e CA A share a general concern aboutth e public' s exposur e to toxi c chemical s produced b y mobil e sources , EP

A believe s tha

ttiiey ca n complementrathertha

n duplicate or supplanton e another . Sectio n 202(1) addresse s th e toxi c emission s themselves , whil e sectio n 211(b ) focuse s o n th e components and effects o f emission s generate d b y particularmotor vehicl e fuel s an d additives
. Th e required study undersectio n 202(1) ma y orma y no tidentif

y any fuel-relate d cause s o f toxi c ai rpollutants , whil e th e testin g required undersectio n 211(b ) wil l provid e such information
. Thi s shoul d prov e useful i n EP

A decisionmakin g regarding th e nee d forfeasibility of additional vehicl e orfue

l regulation s to reduce toxi c emissions
. Furthermore, a differentregulator

y approach underline s eac h o f th e tw o statutes . Sectio n 2020 1 seek s t o detennin e th e exten tt o whioh existin g toxicologi c dat

a o n specifi c identifie d ai rpollutants warrant s additional regulation , and require s certai n EP A action s i n thi s regar

d b y rwd-1995
. Th e purpos e o

f th e curren

t Rulemakin

g i s t o establis h testin g requirement

s tha twil l provid e EP

A wit h adequate information o n th e emission s effects o f existin g and futur

e fuel s and additive s t o determin e whethe rth e commercia

l distributio n orus e o

f any suc h fuel s oradditive s shoul d b e controlled . 2
. Emissio n Contro

l Syste m Testin g Several respondents representin g segments o

f th e vehicl e an d engin e manufacturing industrie s favore d iagorous requirement

s for testin g th e potential effects o

f fuel s an d fue

l additive s o n vehicula remissio n control performance
. Thes e respondents maintai n thatemissio n control tes t requirement

s underthi s rulemaking sheul d involv e differentdrivin g cycle s ferurba n vehicles , tracto rtrailers , and alternativel y fuele d vehicles , an d shoul d includ e such parameters a s long-ter m durability , deterioratio n rate , wear , coBrosion , deposition , an d compatibilit y with a variet

y o f lubricatin g oi l formulations. Furthermore, they argued tfea * tes trequirement

s for existin g product s shoul d b e jus ta s stringenta s thos e required fo

rth e marke

tentr y o f ne w fuel s and additives , an d tha tth e effects of eac h fue l oradditiv e o n emissio n control performance shoul d b e teste d i n a statisticall y significan t sampl e o f engines
. IP A recognize s th e concern s of thes e respondent s regarding th e potential impactof fuel and/o radditiv e formulations o n emissio n contro l syste m integrity
. O n th e othe rhand , i ti s noti n th e publi c interes tt

o establis h registratio n requirement

s s o onerou s tha ttiiey woul d discourag e th e introductio n of

beneficia l ne w additive s an i alternativ e fuels
. IP A believe s tha

tth e existin g prohibition s i n sectio n 211(f ) hav e avoide d thes e unfavorabl e results whil e preventin g tiie introductio n o f fuel s an d additive s whic h woul d significantl y degrad e th e performance of emissio n cofttro l equipment
. I

n effect , thes e mechanism s cal l foremissio n control testing o f fuel s and additive s onl y whe n thei r compositio n departs significantl y from tiie general range of

fue l formulations whic h woul d ordinarily b e anticipate d b y manufacturer s o f moto r vehicl e engine s an d emissio n control devices
. Thi s objectiv e ha s bee n accomplishe d b y th e issuanc e o f interpretiv e ude s whic h la y outspecifi c chemical an d physica l criteri a fo ra category o

f fuei s and additive s considere d "substantiall y similar " t o certificatio n gasolin e fuel s (4 6 F R3858 2 and 56 F R5352)
. Product

s whic h meet thes e "su b sim " criteri a ca n b e place d i n commercia

l us e withou tfirstundergoing testin g t o determin e thei rpotential emissio n control impact
. Conversely , manufacturers o

f fuel s and additive s whic h d o notconfor

m t o th e "su b sim " criteri a ar

e required t

o apply fo ra waive ro f sectio n 211(f

) restrictions
. Thi s proces s requires th e waive rapplicantt o demonstrate , throug

h testin g i f necessary , tha

tsuch product

s d o not decreas e th e ability o f

vehicula r emissio n control system s t o comply wit

h emissio n standards . Sectio n 211(f

) wa s passe d b y Congres s in 1977,
. seve n year s after enactmen tof

th e sectio n 211(b ) provision s whic h are th e primar y subjec to f today' s propose d rulemaking
. I n EPA' s judgment, th e mechanism s alread y implemente d undersectio n 211(f ) ar e adequate t

o satisf y the sectio n 211(b ) requiremen

tfo rtestin g t o determin e th e effect s o

f fuel s an d additive s o n emissio n control systems . Three factor s mus tb e considere d in thi s regard : (1 ) Th e adequac y o f tes t procedure s conducte d forth e purpos e o f waive rapplication s undersectio n 211(f) , (2) th e adequac y o

f existin g "su

b sim " criteri a fo rdeterminin g whic h fuel s an d additive s mustappl y fo

ra sectio n 211(f

) waiver , and (3) th e scop e o f sectio n 211(f ) prohibitions
. Thes e factors ar e discusse d below . (1 ) Adequacy of

testing. Whil e EP

A believe s thatth e leve l of emissio n control syste m testin g conducte d i n suppor tof sectio n 211(f)(4) waive r requests ha s generall y bee n appropriat e an d effective , th e comments summarized a tthe. beginnin g o

f thi s subsectio n indicat e tha

tsom e industr

y segments conside rsuch testin g inadequate for determinin g th e potential impac to f fuel s and additive s o n emissio n control devices
. T o th e exten ttha tmor e comprehensiv e or standardize d emissio n contro l tes trequirement s migh t b e needed , EP

A believe s the y shoul d b e implemente d a s change s t o th e existin g waive rapplicatio n procedure s unde r sectio n 211(f

) rather tha

n a s new , overlappin g regulation s undersectio n 211(b)
. Whil e such revision s ar e outsid e th e scop e o

f th e propose d rulemaking , EP A woul d separatel y welcom e suggestion s regarding possibl e change s i n conjunctio n with sectio n 211(f)
. (2) Adequacy of

"substantially similar" criteria. I

n EPA' s view , mor

e tha n a decad e o

f experienc e ha s demonstrate d th e practical valu e of th e "substantiall y similar " concep tfo r determinin g whethe ra fue l o radditive s need s t o b e teste d forits effects o n emissio n control equipment
. Among gasolin e fuel s and thei rrelate d bul kP. 6

Federa l Registe r

/ Vol

. 57 , No

. 7 3 /

Wednesday , Apri l 15 , 199 2 / Propose dRxile s 1317 1
additive s (th e onl y fuel/additiv e categorie s subjec t

t o sectio n 211(f

) prohibition s prio r

t o th e 199 0 CA A Amendments) , EP

A i s no t awar e o f instance s i n whic h product s excuse d fromtestin g becaus e the y me t "su b sim " criteri awer e late r

discovere dt o hav e advers e effect s o n vehicula r emissio n contro l performance

. Rathe r tha n tightenin g u p th e criteria , th e Agenc y ha s bee n persuade db y practica l experienc e i n conjunctio n wit h th e waive r applicatio n proces s t o publis h a revisio n of

th e "substantiall y similar " definition , whic h raise dth e limitatio n o n th e amoun t

o f oxyge n permitte di n formulation s considere dt o b e "su b sim"

. (3 ) Scope of

section 211(f) prohibitions. Unti l th e 199 0 CAA Amendment s wen t

int o effect , th e statutor y languag e of

sectio n 211(f

) wa s interprete da s applyin g onl y t o unleade d gasolin e fuel s an drelate dbul k additives

. Interpretiv e rule s establishin g th e criteri afor

fuel s an dadditive s considere dt o b e "substantiall y similar " t o certificatio n fuel s thu s wer e publishe d onl y fo r product s i n th e unleade d gasolin e category

. Wit h enactmen t o f th e 199 0 CAA Amendments , al l type s of moto r vehicl e fuel s an dadditive s wer e place dunde r

sectio n 211(f

) jurisdiction

. Propose dcriteri afor

fuel s an dadditive s considere d"substantiall y similar " t o diese l fue l hav e no w bee n publishe d(5 6 F R24362-3

. Ma y 30,1991)

. I n addition , "su b sim " criteri aappropriat e t o othe r fuel/additiv e categorie s ar e no w unde r developmen t

o r planne dfo r

al l fuel s (othe r tha n leade dgasoline ) for whic h certificatio n procedure s an demissio n standard s exist

. However , th e expande dscop e o f sectio n 211(f

) applie s onl y t o product s first introduce dint o commerc e o n o r afte r Novembe r

15,1990 , th e effectiv e dat e of th e CAA Amendments

. Consequently , alarg e numbe r o f product s introduce dand/o r registere d prio r t o thi s dat e wil l stil l fal l outsid e th e regulator y domai n of

sectio n 211(f)

. Thes e "grandfathered " product s includ e aftermarke t

additive s sol dfor

us e i n gasoline-powere dvehicles , a s wel l a s al l non-gasolin e fuel s an dfuel additives , introduce dprio r

t o th e 199 0 CA A Amendments

. I

f thes e product s ar e t o b e subjec t t o possibl e testin g requirement s an dregulator y contro l o n th e basi s o f thei r potentia l emissio n contro l effects , th e statutor y authorit y ha s t o deriv e fromsection s 211(b ) an d(c ) rathe r tha n sectio n 211(f)

. Th e possibilit y tha t

som e grandfathere dproduct s ma y hav e deleteriou s effect s o n emissio n contro l performanc e i s addresse di n th e propose drulemakin g a s follows

. In general , sectio n 211(b ) provision s relatin g t o emissio n contro l syste m testin g ar e integrate dwith th e regulator y structur e o

f sectio n 211(f)

. Product s no t

subjec t t o sectio n 211(f

) becaus e the y wer e first

introduce dprio r t o th e effectiv e dat e of

th e applicabl e prohibitio n woul dno t

routinel y b e require dt o underg o emissio n contro l testing

. However , th e propose d rulemakin g provide s amechanis mb y whic h EP A ca n choos e t o requir e testin g fo r suc h grandfathere dproducts , simila r t o th e testin g whic h awaive r applican t woul dhav e t o conduct , if s o petitione d b y outsid e partie s o r

i f othe r informatio n availabl e t o th e Agenc y indicate s tha t suc h revie w i s appropriate

. Thi s topi c i s furthe r discusse dbelo w i n sectio n III.D

. 3

. Groupin g Provision s Th e ANPR

M discusse dEPA' s inten t t o develo p agroupin g syste mb y whic h manufacturer s o

f similar fuel s an d additive s coul dvoluntaril y poo l thei r effort s an dresource s t o satisf y progra m requirements

. Accordin g t o thi s plan , fuel s an dadditive s woul db e groupe d accordin g t o criteri aspecifie db y EPA

. Representative s fromeac h grou p woul d the n b e selecte dfor

testing , wit h th e tes t result s an dattendan t

cost s share db y th e participatin g manufacturers

. A s a result , bot h cost s an dduplicativ e effort s woul db e reduced

. Publi c commen t

abou t th e groupin g concep t wa s generall y supportive

. However , a t

leas t on e responden t pointe dou t

tha t participatio n i n cooperativ e testin g arrangement s woul d no t b e aviabl e optio n fo

r maker s of proprietar y specialt y fuel additives , becaus e valuabl e trad e secret s abou t produc t formulation s woul dhav e t o b e reveale dt o potentia l competitors

. EP A acknowledge s tha t

th e opportunit y for grou p participatio n will b e mos t attractiv e t o manufacturer s of generi c o r commodity-typ e products

. O n tiie otiie r hand , ther e ar e anumbe r of approache s unde r whic h grou p participatio n ma y no t requir e detaile dchemica l formulation s t o b e divulged

. Fo r example , person s coul dus e a n agent , suc h a s a n accoutin g firmo r atrad e association , t o coordinat e testin g an d represen t th e grou p t o EP

A whil e preservin g th e anonymit y of th e othe r member s i n th e group
. Manufacturer s o f specialt y product s wil l hav e t o judg e fo r themselve s whethe r

th e ampun t

o f confidentia l busines s informatio n tha t mus t b e reveale di n orde r

t o participat e i n grou p testin g arrangement s i s acceptabl e t o them

. I n regar dt o th e developmen t of

. criteri afor

establishin g th e groups , a numbe r o f respondent s suggeste dtha t fuel s an dfue l additive s b e groupe d accordin g t o thei r

emissio n components

. EP A agree s tha t

emissions-base d groupin g woul db e ideal , bu t unti l thi s rulemakin g ha s gon e int o effect , th e requisit e informatio n o n emissio n wil l no t b e available

. Recognizin g thi s problem , som e respondent s suggeste d tha t EP A first collec t emission s dat a fromfuel an dadditiv e manufacturer s an dthe n develo p th e groupin g criteria

. However , t o follo w thi s suggestio n woul dnecessitat e tw o separat e regulator y proceedings : A preliminar y rul e requirin g manufacturer s t o submi t th e results'o f

emissio n speciatio n procedure s an dasecon drul e creatin g a n emissions-base dgroupin g syste m an dpromulgatin g regulation s t o implemen t

al l o f th e othe r progra m requirements

. Thi s i s no t aviabl e alternativ e for

th e Agency , give n th e tim e constraint s of

th e statut e an dth e provision s of

th e Consen t

Decree

. Therefore , th e groupin g syste mpropose d her e i s base do n th e compositio n o f ra w fuel s an dadditives , with th e underlyin g assumptio n tha t

fuel s an dadditive s with simila r ra w constituent s wil l generat e simila r emissions

. Som e respondent s submitte dspecifi c suggestion s t o EP

A concernin g th e definitio n o f

fue l an dadditiv e groups
. Fo r example , on e responden t propose d tha t fuel s b e subdivide dfo

r healt h testin g o n th e basi s of

thei r octan e numbe r and/o r PON A numbe r (paraffins , olefins , naphthenes , an d aromatics)

. EP

A ha s no t foun dthes e numerica l indexe s usefu l for distinguishin g meaningfu l healt h effect s testin g groups
. Moreover , th e significanc e of

th e associate d hydrocarbo n proportion s i n th e ra w fue l stat e wil l b e reduce di n th e cas e of th e exhaus t emissio n b y th e "homogenizing " effec t of th e combustio n process
. Nevertheless , recen t

evidenc e suggest s tha t varyin g th e relativ e olefi n and/o r aromati c conten t

o f afuel ma y impac t th e concentratio n of

som e emissio n components

. Thus , olefi n an daromati c conten t ar e amon g th e parameter s unde r consideratio n b y EP A fo r definin g group s o r selectin g grou p representative s fo

r testing

. Opinion s differe damon g respondent s abou t th e usefulnes s o f

th e sectio n 211(f

) "substantiall y similar " criteri ai n th e contex t of agroupin g syste mfo

r fuel an dadditiv e healt h testing

. A s previousl y described , th e "su b sim " criteri acurrentl y serv e t o designat e whic h fuel s an dfuel additive s mus t obtai n awaive r

of sectio n 211(f

) prohibitions

. Whil e som e respondent s endorse dth e incorporatio n o f existin g "su b sim " criteri aint o th e groupin gP. 7

1317 2 Federa l Registe r / Vol

. 57 , No

. 7 3 /

Wednesday , Apri l 15 , 199 2 / Propose dRule s
syste mfo r healt h effect s testing , other s fel t tha t th e resultin g "su b sim " grou p woul db e to o broa dt o allo w th e healt h tes t result s obtaine dfo

r selecte d representative s t o b e generalize dt o th e grou p a s awhole

. EP A believe s that , i n mos t

respects , th e "su b sim " criteri a(5 6 F R5352 , Februar y 11,1991 ) ar e usefu l determinant s of

"baseline " conventiona l fuel s an dfue

l additive s (se e sectio n I

V o f thi s NPRM)

. Th e establishe dcriteri a restric t th e elementa l compositio n of "su b sim " formulation s t o carbon , hydrogen , oxygen , nitrogen, an dsulfur , with limit s place do n th e amoun t o f methanol , oxygen , sulfur , an dcertai n othe r substances

. However , EP A i s considerin g severa l variant s o f thes e criteri afor

distinguishin g betwee n "baseline " an d"non-baseline " formulations

. Extrem e concentration s o f aromatic s an dolefin s ar e tw o possibl e distinguishin g characteristics

. A differen t restrictio n o n th e amoun t o f oxyge n permitte di n baselin e formulation s i s anothe r

possibility

. Th e oxyge n restrictio n fo

r "su b sim " fuel s i s currentl y 2. 7 percen t

b y weigh t

(an d somewha t

highe r fo r certai n waivere d fuel s an dadditives) , an dthi s ma y b e appropriat e for

definin g baselin e formulation s i n thi s propose dprogram
. However , EP

A i s als o considerin g restrictin g baselin e formulation s t o thos e wit h les s tha n 1. 5 weigh t percen t of oxygen
. I n th e latte r

case , "reformulated " fuel s woul db e exclude d fro mth e "baseline " classification

. Thi s woul dresul t

i n th e generatio n o

f mor e explici t informatio n fo

r variou s oxygenate dgasolin e fuels

. 4

. Healt h Effect s Testin g Provision s A numbe r

o r respondent s argue dtha t a n overl y stringen t

an dexpensiv e healt h effect s testin g progra mwoul db e counte r t o th e publi c interes t

The y pointe dou t tha t unreasonabl y hig h cost s o f program complianc e woul ddiscourag e th e developmen t

o f ne w fuel s an dadditive s an dwoul dreduc e th e availabilit y o f product s potentiall y beneficia l t o th e publi c healt h an dwelfare

. Whil e th e testin g progra mmus t

provid e adequat e informatio n fo

r assessin g th e toxicity o

f fuel s an dadditives , EP

A i s wel l awar e of th e importanc e o

f strikin g a n appropriat e balanc e betwee n scientifi c demand s an dtechnica l an dfinancial constraints , takin g int o accoun t both th e nee dfo r adequat e informatio n an dth e nee dfor continue dinnovation

. Th e Agenc y believe s tha t

th e progra m outline di n th e propose drulemakin g i s consisten t

with th e statut e an dreflect s a reasonabl e an dcost-consciou s approac h t o avery comple x regulatory area
. I n comment s directe da t th e healt h assessmen t

approache s describe di n th e ANPRM , respondent s urge dEP A t o includ e provision s for

takin g relevan t existin g informatio n int o account , t o us e atieredtestin g approac h a s amean s fo r identifyin g product s whic h shoul d underg o long-termstudy , an dt o tak e advantag e o

f existin g standardize dtes t guideline s wheneve r

possible

. Thes e suggestion s ar e reflecte di n today' s propose drule

. Som e respondent s state dtha t successfu l implementatio n of abroadly

base dhealt h effect s testin g progra m wa s doubtfu l i n vie w o

f th e man y technica l problem s whic h mus t first b e overcome
. The y maintaine dtha t year s of testin g woul db e require dt o validat e tes t protocol s an destablis h baselin e data , i n vie w of

th e chemica l complexit y o f fue l an dadditiv e formulation s an d th e impac t

of vehicl e choice , engin e type , emissio n contro l technology , an d operatin g condition s o n th e compositio n o f emissions

. EP A i s wel l awar e o

f thes e technica l difficulties , bu t

doe s no t agre e tha t

the y ar e insurmountable

. Today' s propose d rul e contain s anumbe r

o f proposal s fo

r bringin g th e source s o

f variabilit y unde r reasonabl e control , includin g rule s fo r th e selectio n an doperatio n of vehicle s an dequipment , bas e fuel specification s fo r eac h majo r

fuel/additiv e family , standardize dprocedure s fo r th e generation , sampling , an dstorag e o f emissions , an dguideline s fo r anima l inhalatio n exposur e testing

. Togethe r wit h experimenta l contro l requirements , thes e measure s shoul dreduc e th e testin g program' s inheren t variabilit y t o acceptabl e limits

. EP

A invite s comment s fro mth e publi c o n th e adequac y o f thes e measure s an do n way s t o improv e them

. Man y commenter s urge dEP A t o "se t priorities " for

testin g amon g th e larg e univers e o

f moto r vehicl e fuel s an dfuel additive s potentiall y subjec t t o th e propose drulemaking

. However , ther e wa s littl e agreemen t

abou t whic h specifi c formulation s o r

produc t categories—fuel s vs
. additives , conventiona l vs
. reformulate dvs
. alternativ e fuels—shoul db e place dhig h an dlo w o n th e priorit y list

. Unde r sectio n 211 , Congres s ha s mandate dtha t EP A enac t aschem e fo

r testin g tha t woul dgenerall y an dreasonabl y asses s th e healt h risks o

f al l fuel s an dfue

l additives

. Therefore , EP

A ha s propose d agroupin g syste mwhic h provide s a n efficient mechanis mfor

obtainin g informatio n o n al l type s o f fuel s an d additives

. A syste mo

f evaluatio n tier s ha s als o bee n developed , enablin g EP A t o determin e whethe r

mor e definitiv e testin g i s neede dfo

r an y particula r

fuel s o r

additive s (o r

type s o f fuel s an d additives ) base dupo n toxicit y an d exposur e dat aobtaine dfro mth e literature , fro

mmodelin g techniques , an dfro mabatter y of

screenin g tests

. Finally , EP

A intends , unde r

sectio n 211(e)(3)(C) , t o recogniz e existin g adequat e dat aa s complianc e with th e rule

. Relate dcomment s wer e submitte d regardin g th e applicabilit y o f program requirement s t o fuel additive s whic h ar e considere d"substantiall y similar " t o conventiona l fuels

. Som e respondent s pointe dou t

tha t whe n a"su b sim " additiv e i s mixe dwith gasolin e i t i s extremel y difficult

i f no t impossibl e t o differentiat e fro

mth e fuel itself

, an dtha t effort s t o detec t

th e negligibl e contributio n of

suc h a n additiv e t o th e emission s produce db y th e gasoline / additiv e mixtur e woul db e futilei Thus , accordin g t o thes e respondents , "su b sim " fuel additive s shoul db e exemp t fromprogra mrequirements

. EP A agree s with som e o

f th e reasonin g behin dthes e arguments

. Th e publi c healt h an dwelfar e provision s i n thi s rulemakin g ar e concerne dwith th e impac t of emission s generate db y fuel s an dfue l additive s i n norma l use
. Sinc e additive s ar e properl y use donl y i n conjunctio n with thei r

associate dfuels , progra mrequirement s pertainin g t o th e potentia l effect s o

f additive s ar e focuse d specificall y o n th e emission s o f th e respectiv e fuel/additiv e mixtures

. Fo r additive s with essentiall y th e sam e chemica l makeu p a s thei r paren t fuels , currentl y availabl e technolog y wil l generall y no t

b e capabl e o

f differentiatin g th e emissio n product s o f th e additive/fue l mixtur e fromth e
. emissio n product s o

f th e paren t

fue l itself

. EP A doe s no t

agree , however , tha t

th e manufacture r

of a n additiv e shoul db e relieve do

f registratio n responsibilitie s jus t becaus e ofth e additive' s similarit y t o it s paren t

fuel

. Instead , provision s withi n th e propose dgroupin g syste m shoul db e abl e t o accoun t fo r thes e relationships

. Suc h mechanism s ar e discusse dfurthe r

i n sectio n IV , below

. 5

. Smal l Busines s Provision s Unde r sectio n 211(e) , EP

A i s authorize dt o creat e specia l progra m allowance s and/o r

exemption s whic h woul dreduc e th e burden s of progra m complianc e fo

r smal l businesses

. I

f EP A shoul dchoos e t o exercis e thi s authority , th e operativ e definitio n o f asmal l busines s woul db e specifie dwithi n th e associate dregulations

. Respondent s wh o commente do n thi s matte r felt tha t an y smal l busines s definitio n woul db e arbitrar y an dunfair

. I

n thei r view , smal lp.a .

JFederai l Kegiste r /

Vo L 67
. No . 7 3 /

Wednesday . Apri l 15 , 199 2 / Propose d Rule s 1317 3
busines s provision s coul d potentiall y plac e individual manufacturer s wh o sol d multipl e low-volum e product s ata disadvantag e relativ e t o single-product manufacturers
. The y als o believe d tha t th e rule s governin g smal l busines s allowance s coul d b e manipulate d b y large manufacturers , creatin g loophole s neve rintende d b y EP A Whil e EP A doe s notnecessaril y share eac h of th e respondents ' concerns , thi s NPR M doe s no tcontai n specifi c propose d provision s forsmal l businesses
. I

n general , th e propose d grouping scheme , tiere d testin g structure , an d othe rgeneral provision s shoul d assur e thatundue burden s are no tplace d upo n smal l businesses
. Nevertheless , EPA' s analysi s indicate s thatth e cost s p

f complianc e with th e propose d progra

m may plac e a fe w smal l businesse s i n financial jeopardy
. EP A i s thu s attemptin g t o identif y th e characteristic s which may make som e smal l companie s unusuall y vulnerabl e t o th e potentia l financial impactof th e propose d requirements , an d t o specif y fai ran d appropriat

e approache s fo

r providin g cos trelief

t o such companies
. Thes e topic s ar

e discusse d furthe

rin sectio n Vffl.C
. E.KeyTerma A fuel i s define d t o b e any materia l which i s capabl e o f

releasin g energy or powe rb y combustio n o rotiie rchemical o rphysica l reaction
. Onl y fuel s intende d fo r us e i n moto rvehicle s ar e include d unde rth e propose d regulations
. Currently , fuel s intende d fo rus e exclusivel y ta off-road vehicle s ar e no t designate d fo rregistration
. Bot h domesti c an d foreign product s are include d i n th e designation
. A fuel additive i s an y substanc e tha t i s intentionall y adde d t

o a fue l an d tha t i s no tintentionall y remove d priort o sal e oruse . Bulk additives are product s which ar e adde d t o fue

l before tiie fue

l i s commerciall y availabl e for introductio n into th e fuel tank of a moto r vehicle , whethe radde d a tth e refiner y a s par tof th e original blendin g strea m o r afte rth e fuel ie transporte d fro m th e refinery
. Aftermarket

additives are . product s markete d fo rintroductio n directl y into th e fuel syste m o f a moto r vehicle
. A base fuel

i s a generi c fuel formulated from a se to f

specification s ' to,represen ta give n fuel famil y an d use d i n conjunctio n with th e testin g p f additive s i n thatfamily
. Combustion emissions ar e th e exhaus t product s o f th e combustio n o f

fuel and / oradditive s i n a motorvehicl e engine
. Fo rth e purpose s of

thi s rulemaking , thi s designatio n (refer

s t o controlle d exhaus t product s (Le.
. post-aftertreatment tailpip e emissions ) unles s otherwis e specified
. Evaporative emissions ar e chemical compound s emitte d into th e atmosphere b y vaporizatio n o f

tiie components o f

a fue l oradditive/fue l mixture
. Fo r purpose s of

thi s rulemaking , th e ter

m "evaporativ e emissions " refer s bot h t o emission s create d b y vaporizatio n from th e fue l syste m o f

a motorvehicl e (ho t soak , diurnal , and runnin g losses ) a s wel l a s thos e displace d from th e fue l tan k b y incomin g fuel durin

g refuelin g operations
. Atmospheric transformation products are compound s formed i n th e atmosphere from th e reaction s of primar y emission s such a s volatil e organi c compound s (VOCs ) i n th e presenc e o f

atmospheri c gase s suc h a s nitroge n oxides
. Th e formatio n o f many suc h compound s als o require s th e presenc e o f

sunligh tTransformatio n products includ e ozone/formaldehyde , peroxylacety l nitrate (PANJ , an d othe r nitrate d an d oxygenate d lo w molecula r weigh torgani c compounds . III . Progra

m Scop e A. Overall

Purpose and

Applicability Sectio n 21 1 o f

th e Clea n Ai r Ac t establishe s a framework for registerin g moto rvehicl e fuel s an d additives , fo r gatherin g informatio n abou tthem , an d fo rpossibl y limitin g o rprohibitin g thei r commercial distributio n an d sal e whe n th e availabl e informatio n warrants suc h action
. Previou s regulatory action s hav e implemente d section s 21 1 (a ) an d (b)(1) , whic h gover n tiie genera l registratio n o f fuel s an d additives , a s wel l a s sectio n 211(f) , whic h prohibits th e commercial introductio n o f

certai n fuel s an d additive s prio rt o a demonstratio n by th e prospectiv e registrants thatthes e products d o no tadversel y affec t emissio n contro l syste m performance
. - Today' s Notic e propose s ne w registratio n requirement

s fo rmoto r vehicl e fuel s an d fue l additive s unde r section s 21 1 (b)(2 ) an d (e)
. Uies e section s grantEP

A authorit

y t o require informatio n o n th e potentia l health , welfare , an d emissio n contro l syste m effect s associate d wit h moto rvehicl e fuel s an d additives , an d t o specif y procedure s an d protocol s t o b e use d b y fuel an d additiv e producers i n complyin g with thes e requirements
. Th e propose d ne w requirements woul d appl y t o an y moto rvehicl e fuel o r additiv e whic h i s alread y registere d o r i s subjec tt o tiie general registratio n requirement

s i n effectunder section s 211(a) an d 211(b)(1)
. A tth e presen ttime , thi s designatio n encompasse s bot h curren tand ne w gasolin e an d diese l fuel s an d additive s produced an d commerciall y distribute d forus e i n moto rvehicles
. Whjl e alternativ e fuel s an d thei radditive s ar

e notye t designate d forregistration , EP A plan s t o designat e the

m before thi s propose d rule become s final. Currently , fuel s and fue l additive s intende d only fo roff-roa d vehicula rus e (e.g. , i n far

m and constructio n equipmen taircraft , boats , an d railroad engines ) d o no tnee d t o b e registered , ari

d thu s ar e notsubjectt

o th e ne w registratio n requirement s propose d i n thi s rulemaking
. However , if thes e fuel s an d additive s ar e covere d underfutur

e registratio n requirements , thi s progra

m (modifie d a s needed ) woul d exten d t

o the m a s well . B y thi s propose d rule , EP A intend s t o satisf y Congress * mandate unde rsectio n 211(e ) thatEP

A implementit s authorit

y undersectio n 211(b)
. EP

A interprets sectio n 211(b ) t o giv e i tth e authorit y t o requir e testin g o f

fuel s an d fuel additive s t o Identif

y thei rhealt

h an d environmental effects
. Sectio n 2li(b) , however , mus tb e rea d i n conjunctio n with sectio n 211(c) , whic h i n par tgive s EP A authorit

y t o contro l o r prohibi tth e manufacture , introductio n into commerce , offerin g forsale , o r sal e o f an y fuel o rfuel additiv e i f tiie Administrato rfind s tha tth e emissio n product s o f suc h fue l o rfuel additiv e "causes , o rcontributes , t o ai rpollutio n whic h ma y reasonabl y b e anticipate d t o endange r th e publi c health or welfare. " Further , th e Administrato rmus tfind thatsuc h prohibition s "Vil l no tcaus e th e us e o f an y othe rfue

l or fue l additiv e whic h wil l produc e emission s whic h wil l endange rth e publi c health orwelfar e t o th e sam e o r greate rdegre e than th e us e ofth e fuel o r fue l additiv e propose d t o b e prohibited. " Therefore , th e purpos e of sectio n 21 1 i s no tt o requir e submissio n o f data an d informatio n fo rit s ow n sake , butt o assis tEP

A i n th e regulatio n of fuel s an d fuel additives
. EP A face s practical constraints i n accomplishin g it s task . Currently , 2,200 fuel s an d 4,30 0 fue l additive s ar e registere d fo ruse . Emission s speciatio n an d emission s toxicit y testin g ar e complex , requiring tiie operatio n o f vehicle s o rengine s i n a laboratory and , i n th e cas e o f

toxicit y testing , th e inhalatio n exposur e o f

animal s t o emission s unde rver y controlle d - conditions
. EP

A know s o f

onl y a fe w commercia

l laboratorie s whic h currently offerth e full range o f

emissio n generatio n an d speciatio n procedure s propose d i n thi s rule , an d i s no tawar e of an y commercia

l biologica l testin g facilitie s which , atth e presen ttime , offertoxicit y testin g service s involvin g th e constan tinhalatio n exposur e o f liv e animal s t o fue l and fue l additiv eemissions
. Also , whil e screenin g

batterie s ca n b e conducte d i n onl y a fe w week s o rmonths , mor e extensiv e testin g ma y requir e lon g ter m exposure s o rth e exposur e o f

mor e tha n on e generatio n o f animals
. Accordingly , th e proposa l attempt s t o addres s thes e practica l constraint s whil e providin g EPA wit h sufficien t informatio n t o exercis e it s authorit y unde rsectio n 211(c)
. First , EP A propose s t o recogniz e adequat e existin g data . B y adequate , EP A woul d recogniz e studie s conducte d reasonabl y i n accor d wit h th e guideline s specifie d i n thi s rule . Second , EP A ha s propose d a voluntar y groupin g schem e b y whic h manufacturer s o f fuel s an d fue l additive s wit h simila rchemica l compositio n ma y tes ton e substanc e a s a representativ e o f

al l substance s withi n th e group . (Becaus e manufacturer s ma y no twis h t o shar e dat a o n th e compositio n o f

tiieirproduct s wit h others , th e groupin g schem e woul d b e voluntary ; however , eac h fue l o rfue l additiv e woul d b e require d t o b e teste d eithe rseparatel y o ra s par to f a group. ) EPA woul d us e th e informatio n from th e tes tsubstanc e t o evaluat e th e risk o f al l substance s withi n th e group , unles s adequat e dat a o n a particula rmembe r o f th e grou p become s available
. Manufacturer s woul d benefi tb y sharin g th e cos to f

testing
. Throug h thi s voluntar y groupin g system , EP A estimate s tiiatamon g currentl y registere d unleade d gasoline , leade d gasoline , an d diese l products , abou t11 5 group s coul d b e formed , whic h i s a muc h mor e reasonabl e numbe ro f testin g subject s give n th e practica l constraint s o n testing
. Tes tdat a obtaine d a s a resul t o f th e propose d rul e woul d thu s giv e EP A a genera l pictur e o f ho w differen t type s o f fuel s an d fue l additive s compar e t o on e another , whic h i s consisten twit h sectio n 211(b ) i n ligh to f EPA' s authorit y unde rsectio n 211(c)
. Fuel s an d additive s registere d a s relabele d product s (i.e. , simpl y repackage d version s o f formulation s whic h ar e als o registere d b y th e origina l manufacturers ) woul d b e specificall y exempte d fro m th e ne w informatio n gatherin g an d testin g requirement s propose d i n today' s rulemaking
. Becaus e separat e assessmen to f relabele d product s woul d clearl y duplicat e the . effort s o f th e origina l manufacturer , EPA ha s chose n t o exercis e th e authorit y i n sectio n 211(e)(3)(C) , whic h allow s EPA t o exemp tfuel s an d additive s fro m th e provision s o f

sectio n 211(b)(2 ) unde r duplicativ e circumstances
. However , i f th e origina l manufacture rshoul d fai l t o fulfil l th e propose d registratio n requirements , the n th e relabele rwoul d b e a tris k fo rlosin g hi s suppl y o f th e relabele d product . Furthermore , EP A

expect s tha tth e origina l manufacturer s wou$#pas a th e cost s o f testin g alon g t o theii 9 customers , includin g repackagers . IiMaBoithe

r matte rpursuan tt o sectio n 211{e)p|(C) , IP A request s commen t fro m th e publi c i n regar d t o th e adequac y o f

existin g informatio n o n "bas>Kne " conventiona l fuel s an d fue l additives , includin g baselin e diesel , unleade d gasoline , an d leade d gasolin e formulation s (a s define d i n Sectio n IV , below}
. A multitud e o f studies , conducte d b y man y researcher s ove r sever-a j decades , hav e addresse d th e emis^iens-base d effect s o f thes e product s o n th e publi c healt h an d welfar e an d o n emissio n contro l syste m performance
. Th e publishe d result s an d conclusion s from thes e test s hav e provide d th e foundatio n fo rman y legislativ e initiative s an d regulator y actions , i n th e are a o f

mobile-sourc e ai r pollutien
. EP A invite s detaile d commen t o n th e exten tto whic h th e availabl e informatio n o n thes e conventiona l fuel s an d additive s i s adequat e fo rongoin g regulator y decision-makin g and , wit h respec tt o th e testin g requirement s propose d k i thi s rulemaking , th e exten t t o weig h significan tgap s ma y stil l remai n i n th e availabl e dat a base . B. Emissions Focus Whil e th e requirement s propose d i n thi s NKR M ar e primaril y concerne d wit h informatio n coUection , th e underlyin g purpos e o f

th e rul e i s t o guid e th e directio n o f

relate d regulator y activitie s whic h migh tb e undertake n i n th e future
. Th e siaM e instruct s EP A t o promulgat e requirement s fo r"reasonabl e an d necessary " informatio n abou tth e effect s o f fuel s an d additive s and , a s describe d above , provide s mechanism s unde r sectio n 211(c ) fo rtakin g actio n base d upo n thi s information
. Therefore , i t woul d appea rmos treasonabl e i n thi s instanc e fo rEP A t o focu s it s informatio n requirement s t o subjec tarea s whic h serv e th e regulator y objective s o f sectio n 211(c)
. Accordingly , EP A interpret s sectio n 21 1 to ; giv e i tauthorit y t o focu s testin g o n th e emission s effect s o f fuel s an d fue l additives
. B y emission s effects , EP A mean s bot h th e effect s from combustio n an d evaporatio n o f

fuel s an d fue l additive s resultin g fro m thei rus e i n moto rvehicles
. Th e purpos e o f obtainin g dat a o n fuel s an d fue l additive s i s t o provid e a basi s fo rfurthe rrisk characterizatio n an d possibl e regulatio n unde rsectio n 21 1 (c]
. CA A sectio n 211(c)(1 ) states : Th e Administrato rmay , fro

m time to tim

e o n th e basi s o f information obtaine d under subseetie n (b ) o

f thi s sectio n orothe r information availabl e to him , b y regulation , control orprohibi tth e manufacture , introduction int

o commerce , offering fo

rsale , orsal e o f an y fue l orfue l additiv e fo

rus e in a motorvehicl e * * * (A ) i f i n th e judgmen

to f the Administrato ran

y emission s produc

to f suc h fue l o rfue l additiv e cause s or contribute s to airpollutio n which ma y reasonabl y b e anticipate d to endange rth e publi c healt

h o rwelfar e * * * or(B) i f emissio n product

s * * * wil l impair* * * the performanc

e o f any emissio n control devic e orsyste m i n genera

l us e * * * Similarly , CA A sectio n 211(c)(2)(C ) states : N o fue l o rfue l additiv e ma

y b e prohibited by the Administrato runderparagrap h (1 ) unles s h e finds , and publishe s suc h finding , tha tin hi s judgmen

tsuch prohibitio n wil l no t caus e th e us e o

f an y othe rfue

l orfue l additiv e whic

h wil l produc

e emission s whic

h wil l endange rthe publi c healt h orwelfar e to th e sam e orgreater degre e tha n th e us e o

f th e fue l o rfue l additiv e propose d to b e prohibited
. Thus , th e plai n languag e o f CA A sectio n 211(c ) state s tha tEP

A i s authorize d t o regulat e fuel s o rfue l additive s base d o n th e impac to f

thei remission s o n healt h o rwelfare
. Thi s i s consisten twit h th e legislativ e histor y o f

th e provisio n a s well . Th e Hous e an d Senat e Report s o n th e CA A Amendment s o f 197 0 lin k th e informatio n t o b e obtaine d unde rCA A sectio n 211(b ) t o EPA' s authorit y t o regulat e unde rCA A sectio n 211(c). 1 Th e Senat e expliciti y stated : I n matter s relate d t o publi c healt

h and welfare , th e Committee' s concern i s wit h th e effecto f th e actua l emission s fro

m th e - tailpipe , no twit

h th e compositio n o f

th e fuel
. The combustio n o

f th e fue l i n it s intende d environment—insid e a

n engin e wit

h emissio n control woul d b e th e prope rcriterion fo

rth e Secretar y t o us e in judgin

g th e healt

h an d welfare effects o

f tha tfuel
. (Leg

. Hist , a t434 ) Th e legislativ e histor y o f th e 197 7 CA A Amendment s als o indicate s tha t CA A sectio n 21 1 i s focuse d o n emission s effects
. Fo rexample , i n characterizin g sectio n 211(b) , th e Hous e repor tstate s tha ti tallow s testin g "t o determin e th e healt h effect s o f th e emissio n product s o f

fuel s o rfue l additives. " aThus , base d o n th e plai n languag e o f

th e statut e an d it s legislativ e history , EP A believe s i ti s reasonabl e t o interpre tsectio n 21 1 o f th e Clea n Ai rAc tt o allo w EP A t o focu s testin g o n th e emission s effect s o f fuel s an d fue l additives
.

1 H . Rep . No . 1140.9 1 Cong
. 2 d Sess
. (1980

) a t13
. reprinte d l n Environmen

tan d Natura l Resources Divisio n o f the Librar

y o f Congress
. 93

d Cong. , 2 d Sess. ; A Legislative Histor y o f the Clea n Ai r Ac t Amendment

s o f 197 0 (Comm
. Prin t1974 ) ("Leg
. Hist." ) a t433-434
. ' N. Rep . No . 294.95t

h Cong.
. 1stSess
. (1977

) a t 25
. reprinte

d i n 197 7 U.S
. Cod

e Cong. ' A Ad
. New s 1103 ,P.1. 0

Federa l ifflr\/;Vol

. 57 , ^9. ^ 73,/ j TWpdfleaday , Apr #15.

- 1992 / Propose dt^pjes



## tmfs"
Th e propose demission s focu s wil l hel p t o avoi doverla p with regulator y initiative s whic h ma y b e take n i n conjunctio n with th e Toxi c Substances

. Contro l Ac t

(TSCA)

. th e Resourc e Conservatio n an dRecovery Ac t (RCRA) , an dth e Occupationa l Safety an dHealth Ac t

(OSHA) ; Unde r

certai n circumstances , th e healt h and/o r welfar e effect s associate dwith th e production , handling , an dus e of fuel s an dadditive s ma y fal l withi n th e domai n o f thes e othe r

regulator y programs
. Restrictin g th e genera l focu s o f today' s propose drulemakin g t o th e effect s o f fue l an dadditiv e emission s wil l hel p t o minimiz e th e potentia l fo r programmati c overlap , r C. Applicability of

Types of Emissions Bot h combustio n emission s (exhaust ) an devaporativ e emission s ar e majo r contributor s t o potentiall y harmfu l ai r pollution , an dbot h ar e include dwithi n th e general , focu s o

f today' s propose d rule

. Concern s abou t

th e publi c healt h impact s of

emission s frombot h of

thes e source s ar e documente di n th e legislativ e proceeding s associate dwith th e enactmen t

o f sectio n 211

. Sinc e tha t time , however , anumbe r

o f existin g an d planne dregulator y initiative s an d industr y innovation s hav e decrease dth e potentia l ris k

o f exposur e t o fuel an d additiv e evaporativ e emissions , includin g th e vapor s whic h aris e from fuele dvehicle s an dthos e whic h ar e release ddurin g refuelin g operations

. Thus

. EP A invite s comment s i n regar dt o th e continuin g nee dfo

r assessin g th e healt h an denvironmenta l effect s o f evaporativ e emissions

. Exhaus t emission s ar e inevitabl e product s o

f th e engin e combustio n process , an drequirement s t o asses s th e potentia l advers e effect s of engin e exhaus t ar e generall y applicabl e t o al l moto r vehicl e fuel s an dfiiel additives

. Thi s i s no t

alway s tru e for

evaporativ e emissions

. I n th e cas e of

fuel s whic h ar e supplie dt o moto r

vehicl e engine s b y wa y of seale dcontainmen t

an ddeliver y system s (e.g. , liquifie dpetroleu mga s an dcompresse dnatura l gas) , th e nee d fo r evaporativ e emissio n testin g i s les s important , sinc e huma n an decosyste m exposure s wil l b e extremel y lo w o r nonexistent

. Fo r

ordinar y liqui dfuel s an dadditives , th e significanc e o f vaporizatio n varie s widely , dependin g o n th e inheren t

volatilit y of

th e fuel o r additive

. I n thi s regard , areadil y availabl e volatilit y measuremen t

whic h correlate s wit h fuel tan k

evaporativ e losse s i s th e Rei dVapo r

Pressur e (RVP)

. Base do n empirica l analysis , EP

A propose s tha t a n RV P of 2. 0 pound s pe r

squar e inc h (psi ) b e designate da s th e threshol dfor determinin g th e applicabilit y of evaporativ e emissio n testin g requirement s fo

r fuels

. Tha t

is , fuel s with RV P o f 2. 0 ps i o r greate r woul db e
. subjec t t o informatio n an dtestin g requirement s establishe dfo r evaporativ e emissions , whil e thos e with RV P les s tha n 2. 0 ps i woul db e excused

. Amon g moto r

vehicl e fuel s availabl e i n today' s marketplace , onl y diese l fuel , with it s extremel y lo w volatilit y reflecte di n a n RV

P of approximatle y 0. 1 psi , fall s belo w th e propose dthreshold

. Gasoline , alcoho l fuels , an dgasoline / oxygenat e blend s hav e RVP s wel l abov e th e 2. 0 ps i cutof

f point , an dwoul dthu s b e subjec t

t o an y requirement s whic h might b e establishe dfo

r evaporativ e emissio n testing

. Argument s pa n b e mad e tha t

othe r RVP cutof

f points.i n the

. rang e o f 2.0-5. 0 ps i might

als o b e appropriate , an dEP

A request s comment s o n th e bes t

alternative

. With respec t

to additives

. EP

A propose s t o requir e evaporativ e emissio n testin g whe n th e applicabl e additive/bas e fue

l mixtur e meet s eithe r of tw o criteria

. First , evaporativ e emissio n testin g woul db e require di f th e RV P of th e additive/bas e fue

l mixtur e i s increase db y 0. 1 ps i o r

mor e i n compariso n with th e RV P of th e bas e fuel alone

. Second , evaporativ e emissio n testin g woul db e require dif th e partia l pressur e of

th e additiv e i n th e vapo r phase , a t 100 degree s Fahrenhei t

an d atmospheri c pressure , i s 0. 1 ps i o r greater

. Th e partia l pressur e o f th e vaporize dproduct s of

th e additive/fue l mixtur e i n ambien t

ai r coul db e determine dthroug h testin g o r b y usin g thermodynami c model s tha t accoun t fo r th e vapo r pressure s an dinteraction s of th e substance s involved

. Whil e th e specifie dcriteri areflec t

aconservativ e approach , the y woul driot requir e testin g whe n a n additiv e ha s anegligibl e volatilit y effect

. '•'!'

. EPA ask s fo r

commen t i n regar dt o th e suitabilit y of

usin g Rei dVapo r

Pressur e an dpartia l pressur e measurement s t o

. determin e th e applicabilit y of evaporativ e emissio n testin g requirement s for

fuel s an dadditives

. Comment s ar e als o invite dregardin g th e propose dthreshol dRV P an dpartia l pressur e values

. I n additio n t o requirement s fo r testin g th e effect s o f

combustio n an d evaporativ e emissions , EP A ha s considere dincorporatin g th e atmospheri c transformatio n product s of suc h emission s withi n th e propose d testin g program
. Transformatio n product s aris e i n th e atmospher e froma serie s of extremel y comple x chemica l reaction s involvin g atmospheri c gase s

. an dvolatil e emissions , usuall y i n th e presenc e of ultraviole t

sunlight

. On e o

f th e result s of

th e transformatio n proces s i s know n a s photochemica l smog ; It s characteristic s includ e reduce d visibility , hig h level s o f

oxidant s suc h a s ozone , formaldehyde , acrolein , peroxyacety l nitrates , an dotiie r oxygenate dan dnitrate dorgani c substances

. Thes e secondar y ai r pollutant s frommoto r

vehicl e emission s ar e prevalen t

i n th e ai r of al l urba n area s i n th e Unite dStates , posin g threat s t o publi c health , vegetation , an d material s whic h ma y surpas s thos e associate dwith th e paren t compound s themselves

. B y causin g cro p losse s an d acceleratin g th e deterioratio n of natura l an dman-mad e material s suc h a s rubber , paint , buildin g stone , an dfabric , urba n smo g als o cause s substantia l economi c losses

. Thus , atmospheri c transformatio n product s ar e amajo r facto r t o b e considere di n characterizin g th e overal l risk s associate dwith fuel an dadditiv e emissions , an dagrea t dea l of stud y o n thei r

formatio n an deffect s i s needed

. A t th e presen t

time, however , rathe r tha n requirin g laborator y testin g o f transformatio n products , EP A i s proposin g atheoretica l approac h t o th e issue

. Th e conduc t

of vali dsamplin g an d testin g procedure s o n th e primar y emission s of

fuel s an dadditive s require s man y technica l problems , t o b e overcom e an dman y source s of variabilit y t o b e addressed

. Thes e complexitie s ar e compounde dfurthe r whe n attemptin g t o creat e secondar y transformatio n product s o f th e
. emission s unde r

controlle dcondition s an dtryin g t o carr y ou t

ameaningfu l testin g progra mo n th e resultin g chemica l mixture

. • ' Whil e th e scientifi c community ha s begu n t o develo p experimenta l method s fo r modelin g emissio n transformatio n processe s i n th e laboratory ^ experienc e i n thi s are ai s relativel y limite dan dth e necessar y facilitie s ar e availabl e i n onl y aver y fe w academi c settings.

. Furthermore , th e curren t

knowledg e bas e i n thi s fiel do f

investigatio n doe s no t permi t th e unequivoca l identification o f caus e an deffec t

relationship s betwee n discret e fuel o r

additive ' formulation s an dspecifi c product s o f photochemica l transformation

. Thus , eve n if abroad-base dtestin g progra m coul db e implemented , th e result s woul d probabl y no t

b e usefu l i n discriminatin g th e specifi c contribution s o f differen t fuel s an dadditive s t o th e formatio n an d effect s o f transformatio n products

. Thes e scientific , technical , an d practica l consideration s hav e persuade d EP A t o exclud e laborator y testin g requirement s for

atmospheri cP.1 1

1317 6 Federa l Registe r / Vol

. S7, 1 No

. 7 3 /

Wednesday ; Apriri5 , 19^ 2 /Appose dRule s
transformatio n product s fromtoday' s propose drule

. However , thes e consideration s d o no t

preclud e theoretica l approache s fo r providin g informatio n abou t

th e photochemica l reactivit y of

th e emissio n product s o

f fuel s an dfue

l additives

. Possibl e approache s includ e th e us e o f mechanisti c kineti c models , whic h ca n i n man y instance s predic t th e degradatio n product s arisin g from atmospheri c photochemica l reactions , o r theoretica l projection s b y qualifie d atmospheri c chemists

. Suc h requirement s ar e include di n th e propose dprogra man dar e discusse d furthe r i n Sectio n VL

B o f thi s NPRM

. Furthermore , requirement s fo r direc t laborator y testin g of

atmospheri c transformatio n processe s ma y b e adde d i n future amendment s t o th e rul e i f advance s i n th e fieldmak e thi s feasible

. D. Scope of

Emission Control

System Testing A s previousl y discusse d(se e sectio n II.D.2) , EPA propose s t o satisf y th e provision s i n sectio n 211(b)(2 ) regardin g emissio n contro l syste mtestin g b y referenc e t o th e existin g fuel an d additiv e waive r

applicatio n progra m implemente dunde r

sectio n 211(f)

. Unde r th e existin g program , fuel an dadditiv e formulation s whic h ar e no t "substantiall y similar " t o designate d" certificatio n fuel s (a s define di n 5 8 F R 5352 , Februar y 19,1991 ) canno t b e introduce dint o commerc e unles s a waive r i s issue db y EPA

. T o obtai n suc h awaiver , th e produce r

of th e fuel o r additiv e mus t

sho w tha t

th e "dissimilar " produc t doe s no t adversel y affec t

th e abilit y of amoto r vehicle' s emissio n contro l syste mt o achiev e complianc e with certificatio n standard s durin g th e usefu l lif e of th e vehicle

. A waive r reques t mus t addres s th e impac t o f th e produc t

o n tailpip e emissions , evaporativ e emissions , material s compatibility , an d driveability

. Thi s ha s typicall y involve d emissio n testin g i n accordanc e with th e Federa l Tes t

Procedur e (FTP) (4 0 CF

R par t 86) and , i n certai n cases , substantia l durabilit y testin g t o asses s potentia l long-termeffects

. Rigorou s protocol s ar e necessar y t o
. ensur e full

y tha t emissio n contro l performanc e wil l no t

b e compromised , an dar e warrante dfo

r fuel s o r fuel additive s whic h depar t

from conventiona l formulations

. A s routin e requirement s for

th e registratio n o

f fuel s an dadditives , however , suc h rigorous an dcostl y protocol s ma y no t b e reasonable

. Th e sectio n 211(f ) waive r programfunction s o n a n exceptio n basis , a n approac h whic h ha s prove n both practica l an deffectiv e a s applie d t o unleade dgasolin e fuel s an d additives

. Revision s currentl y unde r developmen t

wil l exten dth e applicabilit y of

th e waive r

progra mt o othe r fue l an dadditiv e categorie s fo r whic h emissio n certificatio n standard s ar e established

. Thes e change s wil l enhanc e th e capacit y o

f th e waive r programt c adequatel y fulfil l th e aim s o

f th e emissio n contro l testin g provision s o f sectio n 211(b)

. Therefore , th e emissio n contro l syste mtestin g provision s i n today' s propose drulemakin g ar e full y integrate d wit h th e existin g sectio n 211(f ) program
. With respec t

t o ne w fuel s an dadditives , manufacturers ' responsibilitie s i n thi s are awoul db e unchanged

. Product s whic h confor

mt o applicabl e "su b sim " definition s woul dno t

b e require dt o underg o emissio n contro l syste mtestin g befor e the y ca n b e registered

. O n th e othe r hand , ne w fuel s an dadditive s whic h d o no t

mee t "su b sim " criteri a woul db e subjec t

t o th e regular

sectio n 211(f ) waive r applicatio n proces s prio r t o registration

. Th e onl y propose dne w applicatio n o f EPA' s authorit y unde r

sectio n 211(b ) t o requir e emissio n contro l testin g pertain s t o fuel s an dadditive s whic h wer e registere di n th e pas t

eve n thoug h the y wer e no t "su b sim " an ddi dno t

underg o waive r applicatio n procedures

. A s discusse dpreviousl y i n sectio n II.D.2

. of thi s NPRM , suc h registration s hav e occurre dbecaus e fuel an dadditiv e product s othe r

tha n unleade dgasolin e an drelate dbul k

additive s di dno t becom e subjec t

t o sectio n 211(f

) prohibition s unti l th e enactmen t o f th e CAA Amendment s o n Novembe r 15 , 1990

. A s aresult , som e "non-sub-sim " product s introduce dprio r t o tha t dat e wer e allowe dt o b e registere dwithou t firs t undergoin g th e emissio n contro l syste mtestin g whic h th e waive r applicatio n proces s ordinaril y entails

. Nevertheless , i n th e absenc e o f evidenc e linkin g "grandfathered " product s t o emissio n contro l syste mproblems , EP A believe s i t

ma y no t b e reasonabl e o r necessar y t o forc e al l suc h product s t o underg o emissio n contro l syste mtestin g year s afte r

thei r initia l registratio n an d commercia l distribution

. Suc h evidenc e o

f advers e emissio n contro l effect s ma y com e t o ligh t a s a resul t c f emissio n characterizatio n requirement s include dwithi n th e healt h effect s testin g provision s o f today' s propose drulemaking

. Th e propose d emissio n characterizatio n requirement s includ e Federa l testin g procedure s t o determin e th e level s of

regulate d emission s generate db y th e fuel / additiv e o f interest

. Shoul dan y o

f th e regulate demissio n product s excee d establishe dcertificatio n standards , a nee dfo r examinatio n o

f th e product' s effect s o n emissio n contro l ma y b e indicated

. EP A als o propose s t o se t

up a mechanis mwhic h woul dpermi t vehicl e manufacturer s o r

othe r outsid e partie s t o submi t petition s t o EPA , citin g evidenc e tha t

certai n brands , formulations , o r

specifi c component s o

f fuel s o r additive s ar e harmfu l t o vehicula r emissio n control

. I

f EP A judge s tha t

emissio n contro l syste m testin g i s warrante dafte r reviewin g th e petitio n arguments , emissio n characterizatio n results , and/o r othe r availabl e information , th e authorit y provide db y sectio n 211(b ) will b e exercise dt o brin g specifie dfuel s an d additive s int o th e waive r applicatio n progra mwhe n the y woul dotherwis e b e excuse db y th e "grandfathering " provision s of

sectio n 211(f)

. EP A request s comment s o n th e adequac y o

f thi s propose dapproach

. A s a n alternative , th e authorit y of sectio n 211(b ) coul db e exercise dt o requir e al l "grandfathered " product s t o underg o waive r reques t procedure s unde r

sectio n 211(f ) i f the y d o no t

confor mt o applicabl e "su b sim " criteria

. Comment s ar e solicite di n regar dt o th e specifi c necessit y an dth e likel y cost s an d benefit s o f thi s mor e comprehensiv e approac h i n compariso n t o th e mechanis mdescribe dabove

. E. Scope of

Health Effects Evaluation 1

. Backgroun d~ Registratio n requirement s concernin g th e healt h effect s o

f fuel s an dfuel additive s coul dpotentiall y encompas s a vas t rang e o f endpoints , exposur e scenarios , mechanism s of action , an d experimenta l protocols

. Takin g int o accoun t th e numbe r

o f fuel s an d additive s i n question , acomprehensiv e toxicologi c progra mcoul deasil y overwhel mth e capacit y o f existin g laborator y facilitie s an dsuppor t systems , an dth e tota l cost s o f suc h a progra mwoul db e ver y likel y t o excee d it s expecte dbenefits

. Ove r 6,00 0 fuel s an dadditive s ar e currentl y registered , an dthi s populatio n i s expecte dt o underg o furthe r

growth i n th e nea r future a s reformulate dan dalternativ e fuel s an dthei r

additive s gai n awide r rol e i n th e marketplace

. Othe r tha n stipulatin g thre e endpoint s whic h must , a t

aminimum , b e include d i n th e regulations , sectio n 211(b ) give s EP A discretio n t o appl y it s expertis e i n determinin g th e scop e of

th e healt h effect s evaluatio n program
. In exercisin g thi s discretionar y authority , EP A ha s recognize dtha t

som e area s o

f inquir yP.1 2

Federa l Register

. /Vol

. 57 , No

. 73; / < Wednesday , Apri l 15 , 199 2 / Prdpdse diRule s 1517 7
whic h ar e o

f legitimat e scientifi c interes t ma y no t b e reasonabl e o r

necessar y t o includ e i n th e contex t

o f aregulator y program
. Rathe r

tha n mandatin g comprehensiv e healt h effect s testin g a s aroutin e registratio n requiremen t for ever y fuel an dfue

l additive , th e progra m i s designe dtp addres s testin g need s o n atiere dbasis , wit h allowanc e for mor e rigorous, resource-intensiv e requirement s a s indicate db y existin g dat aan dlowe r

tie r screenin g tests

. A s previousl y discussed , EPA' s pla n t o focu s th e rulemakin g o n th e primar y emission s of

fuel s an dadditive s represent s amajo r

reductio n i n th e potentia l scop e o

f th e healt h effect s evaluatio n program
. Consisten t wit h thi s focus , th e propose dhealt h testin g requirement s ar e concerne dwith th e effect s o f inhalatio n exposur e t o th e evaporatio n an dcombustio n product s o f fuel s an dadditives

. The y d o no t specificall y addres s th e possibl e advers e effect s o f

exposur e t o fuel s an d additive s i n th e liqui dstate , no r d o rhe y includ e studie s o

f atmospheri c transformatio n product s excep t a t th e leve l d f dat aanalysi s an dmodeling

. Significan t

reduction s i n progra mcost s an doveral l impac t

o n th e fuel an d additiv e industr y ar e als o expecte da s a resul t of propose dgroupin g mechanism s an dprovision s for

exemptin g relabele d product s fromprogra mrequirement s 2

. Healt h Effect s Endpoint s Accordin g t o sectio n 211(b)(2)(A) , th e endpoint s t o b e addresse db y th e progra mmus t

include , bu t

nee dno t b e limite dto , "carcinogenicity , mutagenicity , an dteratogenicity"

. Carcinogencit y refer s t o th e potentia l o f asubstanc e t o initiat e o r contribut e t o th e transformatio n of

norma l cell s int o neoplasti c cell s an dth e furthe r developmen t

o f neoplasti c cell s int o tumors

. Mutagenicit y i s th e abilit y o f a n agen t t o produc e mutations , i.e., change s i n th e geneti c informatio n store di n th e DN A o f livin g cells

. Whe n suc h geneti c change s occu r

i n germina l tissue , the y ma y represen t

heritabl e events

. Teratogenicity , i n th e strictes t sense , refer s t o th e potentia l o f

asubstanc e t o caus e advers e effect s t o afetu s in-utero , resultin g i n feta l mortalit y o r birt h defects

. I n today' s propose drule , EP A ha s chose n t o expan dthi s categor y t o encompas s genera l reproductiv e toxicity , includin g adul t

fertilit y effects

. I n additio n t o thes e mandator y area s of inquiry/man y othe r

healt h effec t endpoint s ar e german e t o th e assessmen t

o f th e publi c healt h impact s o f fuel an dadditiv e emissions

. A s discusse dfurthe r

below , th e propose d progra mincorporate s aliteratur e searc h whic h cover s al l suc h endpoint s and , o n acase-by-cas e basis , als o provide s fo r possibl e testin g t o follo w u p o n an y significan t concern s highlighte db y th e availabl e literature

. However , testin g will routinel y b e require dfo r onl y tw o healt h effec t

endpoint s i n additio n t o th e mandator y endpoint s describe dabove

. First , consisten t

with th e program' s focu s o n inhalatio n exposure , testin g o f publmonar y toxicit y i s proposed

. Second , i n vie w of

particula r

scientifi c concern s abou t

th e potentia l effect s o f fuel an dadditiv e emission s o n th e nervou s system , testin g for neurotoxicit y i s included

. Neurotoxicit y als o serve s a s agoo dgenera l indicato r

of potentiall y harmfu l chemica l activity

. 3

. Healt h Effect s Evaluatio n Tier s A s depicte di n Figur e 1 , th e propose d requirement s for

evaluatin g th e healt h effect s of fuel s an dadditive s ar e organize dwithi n athree-tie r structure , wit h mor e rigorou s requirement s containe di n eac h successiv e tier

. I n part , eac h tie r

i s intende dt o functio n a s ascree n for

determinin g th e nee dfor an dapplicabilit y o f

requirement s i n subsequen t

tiers

. Th e tiere dapproac h als o permit s fuel an dadditiv e producer s t o mak e full us e o f

tes t result s an dothe r informatio n whic h ma y alread y b e availabl e abou t

thei r products

. Thi s i s consisten t

with th e objective s of

sectio n 211(e)(3) , whic h authorize s EPA t o tak e existin g informatio n int o accoun t t o avoi dduplicativ e testin g requirements

. BILLIN G COO E 6560-50- *

### 1317 8 P.1 3



### Federa l Registe r

/ Vol

. 57 , Np

. 7 3 /

Wednesday , Apri l 15 , 199 2 / Propose dRule s 

### Figur e 1 : Overvie w o f

Evaluatio n Tier s

STAR T

o Characterizatio n o f

emission s o Summar y o f

previou s healt h an d environmenta l studie s o Analyse s o f

atmospheri c reactivity , exposur e potential* , an d environmenta l partitionin g Inadequat e

existin g 

### informatio n 

## Tie r2 Short-ter m test s fo rcarcinogenic , mutagenic , teratogenic , reproductive , pulmonary , an d neurologi c effect s

EP A evaluatio n o f

Tie r1 & 2 dat a an d decisio n o n nee d fo radditiona l testin g

Additiona l testin g neede d Tier3 Additiona l test s (e.g
. lon g ter m anima l exposure s and/o rfurthe remissio n characterization ) prescribe d o n a case-by-cas e basis , t o clarify , verify , o r quantif y th e result s o f

Tier s 1 & 2
.

EN D Adequat e existin g informatio n

Additiona l testin g no tneede d

* "Adequate " implie s tha tth e existin g informatio n include s th e result s o f properl y performe d an d well-documente d studie s comparabl e t o th e test s require d i n Tie r I

BILLING COD E 6560-50- CP.14 ,

Federal ! Kegiste r

/ Vol

. 57 , No

. 7 3 /

Wednesday , Apri l 15 , 199 2 / Propose dRule s 1317 9

I n brief , th e propose drelationshi p betwee n th e thre e evaluatio n tier s woul dfunctio n a s follows

. Eac h manufacture r

of afuel o r additiv e woul d b e responsibl e fo

r satisfyin g th e requirement s of

Tier s 1 an d2

. Th e result s o f bot h o f thes e tier s woul db e reporte dt o EP

A simultaneously , accordin g t o th e repor t

format describe d i n sectio n VII of

thi s NPRM

. T o th e exten t tha t previousl y conducte dstudie s wer e availabl e fo

r th e fuel o r

additiv e whic h satisfie dth e specifie dguideline s fo r th e chemica l and/o r

biologica l test s require di n Tier s 1 an d2 , th e manufacture r

coul dsubmi t

suc h existin g studie s i n lie u o

f performin g ne w duplicativ e tests

. Th e requirement s o f Tier s 1 an d2 coul db e satisfie db y manufacturer s eithe r

o n a n individua l basi s o r b y wa y o f agrou p submissio n consisten t

wit h th e provision s o

f th e groupin g syste mdiscusse di n sectio n IV

. Withi n eightee n month s afte r receip t of arepor t fo r Tier s 1 an d2 , EP

A woul d determin e whethe r

th e submitte d informatio n an dtestin g were , i n fact , i n complianc e wit h th e specifie d guidelines

. Manufacturer s o f existin g product s wh o faile dt o submi t dat ao r submitte ddat afro

mtest s tha t

di dno t compl y wit h th e specifie dguideline s woul db e i n violatio n o

f thi s rul e an d woul db e subjec t

t o th e penaltie s specifie di n CA A sectio n 211(d)

. Suc h person s woul dals o hav e t o submi t th e dat aoriginall y required

. Furthermore , i f EP A determine dtha t

th e dat a requirement s o f

th e rul e wer e no t

met , EP A coul drevok e th e registratio n o f th e subjec t fuel o r additive

. Manufacturer s of fuel s an dadditive s no t

previousl y registere dwoul db e prohibite dfrom registerin g an dsellin g suc h product s unti l EP A determine dtha t

th e requirement s o

f Tier s 1 an d2 wer e me t satisfactorily

. O n th e basi s of

th e submitte dTie r

1 an dTie r 2 dat aan dan y othe r

availabl e information , EP

A woul dals o determine , withi n five year s o

f it s receip t

o f agive n Tie r 1 an d2 submittal , whethe r furthe r testin g of th e subjec t

fuel o r additiv e wer e require dunde r

th e provision s o

f Tie r 3

. A s discusse dfurthe r

below , thi s determinatio n woul ddepen do n th e exten t t o whic h Tier s 1 an d2 provid e sufficien t toxicit y an dexposur e informatio n t o permi t

regulator y decision s t o b e mad e base do n th e severit y an dexten t

of advers e healt h risks. I f Tie r 3 testin g wer e deeme d necessary , EP

A woul dnotif

y th e responsibl e manufacture r (o r group ) by

. certifie dlette r

o f th e specifi c Tie r

3 requirement(s ) alon g with aschedul e fo r complianc e an dadeadlin e fo r submitta l o f th e final repor t

t o EPA

. EP

A woul d provid e th e responsibl e manufacture r

(o r group ) a30-<la

y commen t

perio do n th e Tie r 3 requirements , complianc e schedule , an dsubmissio n deadline

. EP A woul dexten dth e commen t perio di f i t appeare dfro

mth e natur e o

f th e issue s raise dtha t

furthe r tim e for commen t wer e warranted

. I n th e even t tha t EP A receive dn o commen t

withi n th e give n period , th e manufacture r

woul db e considere dt o hav e consente di n ful l t o th e requirements

. T o kee p th e genera l publi c informe d abou t th e statu s of

th e testin g progra m an dt o provid e a n opportunit y fo r publi c inpu t t o th e Tie r

3 decisio n process , EP

A intend s t o implemen t

additiona l notificatio n procedures

. Beginnin g thre e year s afte r

promulgatio n o

f th e final rule , an dupdate da t

leas t ever y tw o year s thereafte r

whil e progra mactivit y remain s high , EP

A propose s t o publis h a notic e i n th e Federa l Registe r containin g th e followin g thre e lists : (1 ) Product s (o r groups ) fo

r whic h EP

A ha s prescribe d Tie r 3 testing , (2) product s (o r groups ) for whic h EP

A intend s no t

t o prescrib e Tie r 3 test s base do n curren t information , an d(3 ) product s (o r groups ) for whic h a n adequat e Tie r

1 an d2 submitta l ha s bee n receive db y EP A bu t for whic h adecisio n o n th e necessit y of Tie r 3 testin g i s stil l pending

. A produc t woul dno t

b e include di n th e notic e unti l EP A ha s receive dth e respectiv e Tie r 1 an d2 submitta l an dha s reviewe di t fo r adequat e complianc e wit h Tie r 1 an d2 requirements

. Fo r si x month s followin g eac h Federa l Registe r notice , EP

A woul daccep t petition s fromth e publi c requestin g tha t particula r product s b e require dt o underg o Tie r

3 testin g whe n EP

A ha s indicate dtha t

suc h testin g woul dno t

b e prescribe do r

whe n th e Tie r

3 decisio n i s stil l pending

. T o b e considere db y EP A suc h petition s woul db e expecte dt o includ e substantiv e reason s for th e specifi c testin g requested

. Th e petition s woul dno t

b e bindin g o n EPA ; however , eac h suc h petitio n an dEPA' s formal respons e woul db e place di n th e docke t fo r publi c inspection

. Th e followin g section s discus s th e genera l scop e of

th e requirement s i n eac h healt h effect s evaluatio n tier an d th e criteri at o b e use di n makin g th e complianc e determination s mentione d above

. Mor e detaile ddiscussio n o f th e individua l tie r

requirement s i s provide d i n section s V-VI I o

f thi s NPRM

. Tier 1. Th e scop e o

f Tie r 1 encompasse s chemica l analysis , literatur e search , an dmodelin g o r analyti c methods

. Thes e component s o f th e evaluatio n ar e designe dt o provid e basi c dat ao n fuel an dadditiv e emissio n product s an dt o permi t

arevie w an d assessmen t o f th e adequac y of

existin g informatio n o n relate dhealt h effects

. Propose drequirement s fo r th e chemica l analysi s o

f fuel an dadditiv e emission s woul dsatisf

y th e provisio n i n sectio n 211(b)(2 ) "t o determin e th e emission s resultin g fromth e us e o f th e fuel o r additiv e containe di n suc h fuel" , an dwoul dals o provid e ausefu l inventor y o

f potentiall y harmfu l fue

l an d additiv e emissio n products

. T o thi s end , manufacturer s woul db e responsibl e fo r th e generation , collection , an dsamplin g of th e combustio n emission s o f thei r fuel s an dadditives , an dfo r th e conduc t o f test s t o determin e th e identit y an d concentratio n o

f individua l emissio n products

. Th e analyse s woul dinclud e (1 ) EP A procedure s fo

r th e measuremen t o f regulate demissions , (2

) chromatographi c procedure s for th e speciatio n of

volatil e hydrocarbo n compounds , aldehydes , ketones , alcohols , ethers , an dpolycycli c aromati c hydrocarbon s (PAH s an dNPAHs) , an d (3 ) specia l procedure s fo

r th e determinatio n of

th e chemica l fat e o

f metals , halogens , an dothe r element s o

f specia l concer n whe n suc h element s ar e know n t o b e presen t

i n th e ra w fuel o r additiv e formulation

. Whe n applicable , evaporativ e emission s woul dals o nee d t o b e generated , collected , an d characterized

. In th e cas e of additives , th e emission s fro

mth e respectiv e additive/bas e fuel mixtur e woul dnee d t o b e compare dwit h th e emission s fro m th e bas e fiiel alone , i n orde r t o distinguis h th e additive' s contributio n t o th e emissio n products

. Th e secon dpropose dTie r 1 requiremen t

i s acomprehensiv e surve y o f th e relevant , scientifi c literature

. Bot h publi c an din-hous e (e.g. , manufacture r o r industry ) source s woul db e include d i n th e survey , providin g acompilatio n of al l availabl e informatio n frompreviou s emissio n characterizatio n an dhealt h effect s testin g don e o n th e whol e emission s an demissio n product s o f th e fuel o r additiv e i n questio n o r

o n th e emission s o

f similar fuel s an dadditives

. Fo r thi s purpose , "similar " fuel s an d additive s woul db e thos e whic h mee t th e criteri afo

r enrollmen t

i n th e sam e fuel/additiv e grou p a s th e subjec t fue l o r additive , pursuan t

t o th e groupin g syste mpropose di n sectio n I V o f thi s notice

. On e o f th e function s o

f th e literatur e searc h woul db e t o determin e th e availabilit y o

f adequat e existin g testin g whic h coul db e submitte db y manufacturer s i n complianc e with th e requirement s o

f th e registratio n program
. I

f th e result s of

th e require d emissio n characterizatio n procedure s mentione dabov e wer e alread y

I l l IIM MI I 'I'Hf' P P.1 5

1318 0 Federa l Registe r / Vol

. 57 , No

. 7 3 /

Wednesday , Apri l 15 , 199 2 /Propose dRule s
availabl e i n th e existin g literature , the n thos e procedure s woul dno t nee dt o b e repeated

. Similarly , manufacturer s coul d us e th e outcom e o f

th e literatur e searc h t o determin e th e applicabilit y o f Tie r 2 biologica l testin g requirements

. T o th e exten t tha t th e literatur e containe d adequatel y conducte dpreviou s studie s tha t conforme dt o th e guideline s specifie dfo r

an y test s include di n Tie r 2 , the n suc h Tie r

2 test s woul dno t

nee dto b e done

. I n determinin g whethe r

suc h previou s studie s wer e adequat e substitute s fo r conductin g th e Tie r

2 tests , th e manufacture r

woul dnee dt o conside r

a numbe r o f factors

. First , th e previou s testin g i n regar dt o an y give n endpoin t woul dhav e t o addres s tiie effect s of inhalatio n exposur e t o th e whol e combustio n o r

evaporativ e emission s of th e respectiv e fue l o r

additive

. Test s performe do n th e emission s of fuel s an d additive s whic h coul db e classifie di n th e sam e grou p a s th e subjec t fuel o r additiv e woul db e considere drelevant , bu t test s o n product s no t

conformin g t o th e relevan t

grou p definitio n woul dno t apply

. Ra w produc t

testing , usin g fuel s o r additive s i n th e liqui dstat e o r a s whol e aerosolize dpreparations , woul d no t suffice

. In general , inhalatio n studie s o n th e individua l emissio n product s of th e fiiel o r

additiv e woul dno t adequatel y substitut e fo r whol e emissions , unles s emissio n characterizatio n studie s showe dtha t a n additiv e ha s onl y on e emissio n produc t tha t differentiate s it s emission s fromth e bas e fuel

. Documentatio n woul dnee dt o b e sufficien t

t o determin e tha t

th e studie s wer e conducte di n amanne r consisten t

with generall y accepte d scientifi c principles , goo dlaborator y practices , an dth e specifi c testin g guidelin e i n question

. Importan t parameter s woul dinclud e th e typ e an d numbe r of tes t subjects , th e numbe r

an d adequac y of

dosages , th e methodolog y an dduratio n of

inhalatio n exposure , an dth e technica l method s use dfo r momtorin g th e progres s of th e tes t an d for analyzin g th e results

. I n general , th e exposur e duratio n woul dnee dt o b e a t leas t a s lon g a s tha t

stipulate di n th e specifie dTie r

2 guideline ; however , shorte r exposure s woul db e acceptabl e i f th e tes t result s wer e positive , includin g ademonstrabl e dose-respons e relationship

. Finally , th e ag e o f th e dat a woul db e aconsideration

. I n vie w of technologica l advance s an dchangin g technica l standards , olde r studie s woul d b e les s likel y t o b e acceptabl e tha n mor e recen t studies

. Nevertheless , th e qualit y of th e stud y woul db e th e decidin g factor , no t

th e ag e pe r

se
. Thes e sam e consideration s woul dlate r b e use db y EP

A i n judgin g whethe r

th e submitte d test s wer e i n complianc e wit h th e progra mrequirements

. Th e thir dpropose dTie r

1 requiremen t woul dinvolv e dat aanalysi s an d modelin g approaches

. Appropriat e method s woul dnee dt o b e selecte dan d use dfor projectin g ambien t concentration s o

f th e variou s emissio n product s an dfo r

evaluatin g th e chemica l reactivit y an dfat e o f

th e emitte d compound s i n th e atmosphere

. Tier 2. Th e secon devaluatio n tier i s compose dof

aserie s of

short-ter m laborator y test s whic h compris e a iriifliHHH B screenin g batter y for

th e previousl y designate dhealt h endpoints

. Mos t o f th e propose dtest s involv e exposur e o

f laborator y animal s to th e whol e emission s of

fuel s o r additive / fuel mixtures

. On e exceptio n i s th e Ame s revers e mutatio n assay , whic h i s comprise do f

aserie s o f

in-vitr o studie s utilizin g bacteria l substrates

. Becaus e mutatio n i s on e o f th e majo r mechanism s involve di n th e transformatio n o

f norma l cell s t o neoplasti c cells , ther e i s som e overla p i n th e screenin g test s require dfor determinin g th e potentia l carcinogenicit y an dmutagenicit y o f fue l an dfuel additiv e emissions

. Propose d Tie r 2 requirement s relate dt o on e o r bof h o f thes e tw o endpoint s includ e (1 ) th e Ame s revers e mutatio n assay , (2) in vivo micronucleu s assay , an d(3 ) in vivo sisiter chromati dexchang e assay
. A s mentione dabove , th e Ame s assa y invoke s in-vitro procedures

. Th e othe r test s i n thi s serie s requir e inhalatio n exposure s of

tes t animal s t o th e emission s o

f th e fuel o r

fuel/additiv e mixture , followe db y harvesting , culture , an danalysi s o f

designate dcel l types

. Ih e propose dscreenin g test s for th e othe r specifie dendpoint s woul d geneBaft y involv e th e controlle d exgrosus e ef

tes t animal s b y inhalatio n t o feel o r additiv e emission s a t

thre e differen t dilution s for

si x weeks

. Followin g th e perio dof

exposure , relevan t structure s woul db e examine d for morphologic , histologi c an d

. functiona l change s relate dt o th e give n enctpeiat

. Developmenta l (teratogenic ) effect s woul db e studie db y exposin g pregnan t female s t o emission s durin g th e Bres t sensitiv e perio dof

pregnancy , followe db y examinatio n o f th e uteru s an dit s content s jus t

prio r t o th e norma l tim e of parturition

. Testin g for

adul t reproductiv e effect s woul drequir e th e exposur e o

f rodent s befor e an dafte r matin g a<n

dthroughou t

pregnancy , wit h sub^efuen t

evaluatio n of

th e offsprin g a s wel l a s analysi s o f

th e reproductiv e organ s an dtissue s of

th e adul t animals

. Togethe r

with th e informatio n from Tie r 1 o n th e compositio n o f

emission s an do n th e estimate dchemica l reactivit y an dpotentia l risk

o f exposur e t o thes e substances , th e propose dTie r 2 test s wil l provid e asubstantia l bod y of dat a o n th e potentia l publi c healt h an d welfar e effect s of

th e emission s produce db y afuel , additive , o r grou p o f formulations

. I

f significan t

advers e effect s appea r

ver y unlikely , th e evaluatio n proces s woul db e complet e a t th e en dof

Tie r 2

. However , i

f th e associate drisks ar e stil l uncertain , additiona l testin g migh t

b e require d unde r Tie r 3

. Tier 3. Afte r th e result s o f

th e first tw o tiers hav e bee n submitte dan dreviewed , EP A wil l detennin e whethe r sufficien t dat aar e availabl e o n th e healt h effect s an dexposur e characteristic s of th e fuel / additiv e emission s t o penni t potentia l regulator y decision s t o b e made

. I f th e informatio n i s adequat e t o allo w EP A reasonabl y t o conclud e tha t th e fue l o r additiv e i s quit e likel y t o hav e eithe r ver y lo w healt h risks o r

unacceptabl y hig h healt h risks, additiona l testin g woul dprobabl y no t

b e required

. However , i

f th e healt h risk

potentia l i s stil l uncertain , additiona l studie s might b e require da t

th e Tie r 3 leve l t o resolv e th e uncertainties

. Th e specifi c Tie r 3 test s require dwoul db e determine do n a case-by-cas e basi s a t

EPA' s discretion

. Whil e EP A wil l no t ordinaril y perfor

m aformal risk

characterizatio n whe n determinin g whethe r

t o exercis e th e Tie r 3 authority , bot h healt h effect s dat aan d exposur e informatio n wil l b e considered

. Fo r

example , i

f th e potentia l healt h effect s o

f exposur e wer e very severe , the n anee dfo

r Tie r 3 woul db e suggeste deve n if

th e expose d populatio n wer e relativel y small

. I f th e potentia l advers e effect s wer e mor e moderat e o r

equivocal , alarge r populatio n woul dgenerall y nee dt o b e a t ris k before Tie r

3 testin g woul db e required

. Additiona l testin g migh t als o b e require dwhe n th e result s o f Tie r 2 test s ar e negativ e (i.e. , apparentl y non
toxic) , i f EP A judge dtha t

inadequat e laborator y procedure s o r technique s interfere dwith th e tes t

results

. Whil e th e specifi c objective s an d scop e of Tie r 3 testin g woul dvar y dependin g o n th e concern s identifie di n th e earlie r

tiers , chroni c (2- 3 year ) inhalatio n studie s woul dsometime s b e included

. Chemica l dispositio n studies , exposur e studies , an ddosimetr y analyse s a s wel l a s additiona l emissio n characterizatio n requirement s might als o b e imposed

. Thes e requirement s woul dmos t

ofte n b e intende da s follow

u p t o studie s include di n Tie r 2

. However , EPA reserve s th e genera lP.1 6

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authorit y t o requir e th e evaluatio n o f othe r endpoint s i

f availabl e informatio n indicate s tha t

thi s i s necessar y fo

r regulator y decision-making

. Fo r example , i

f th e literatur e searc h suggest s tha t th e emission s of

afuel o r additiv e ar e toxi c t o th e live r

o r kidneys , the n EP A woul dno t

b e preclude dfrom imposin g hepatotoxicit y o r renotoxicit y testin g requirement s unde r Tie r 3 simpl y becaus e screenin g studie s fo r thes e endpoint s wer e no t

include dunde r

Tie r 2

. Sectio n V

I of thi s NPR M present s furthe r discussio n o n th e circumstance s whic h woul dlea dEPA t o conclud e tha t Tier s 1 an d2 provid e sufficient informatio n withou t

invokin g Tie r

3 , th e potentia l criteri afo r

imposin g Tie r

3 testin g requirements , an dth e likel y natur e of suc h requirements

. 4

. Timin g Consideration s Th e organizatio n of

th e program' s healt h effect s evaluatio n requirement s int o hierarchica l tiers ensure s tha t th e propose drul e accommodate s th e goal s o f bot h sectio n 211(e ) an dsectio n 211(b)

. Sectio n 211(e ) require s that , fo r existin g fuel s an dfuel additives , th e "requisit e information " b e furnishe dt o EP A withi n thre e year s of

th e implementatio n o

f th e final rule

. Fo r

fuel s an dadditive s no t

yet registere dwhe n th e final rul e i s promulgated , submissio n o f th e require d informatio n will b e aprerequisit e for registration

. However , sectio n 211(e) als o require s EP

A t o implemen t

th e authorit y unde r

sectio n 211(b) , whic h give s th e Administrato r

discretio n t o requir e testin g t o determin e th e potentia l publi c healt h o r

welfar e effect s an dt o "receiv e change s i n th e informatio n required. " Thus , whil e sectio n 211(e ) contain s atim e frame of

thre e year s fo r submissio n of

data , i t als o mandate s tha t EP A implemen t

it s broa d discretionar y authorit y t o requir e th e testin g i t consider s necessar y t o asses s th e publi c healt h an dwelfar e effect s o f fuel s an dfuel additives

. In 1977 , Congres s believe dtha t shor t ter mtestin g method s woul dofte n b e adequat e t o determin e lon g termhealt h effects

. (Se e H

. Rep

. No

. 95-294 , a t 309 , Legis

. Hist , a t

2776 , "However , th e paramoun t

interes t i n protectio n of publi c healt h require s tha t tes t protocol s b e reasonabl y comprehensiv e * * °

. Relativel y inexpensiv e bu t reliabl e tes t method s ar e increasingl y becomin g availabl e for

thes e purpose s an dthes e tes t method s shoul db e utilize dinsofar a s possible." ) Th e propose dshort term test s include di n Tie r

2 reflec t thi s approac h and , indeed , ma y often eliminat e th e nee dfor

furthe r evaluatio n of afuel' s o r

additive' s effect s o n certai n endpoints

. However , thes e "relativel y inexpensive " method s hav e generall y no t advance dt o th e poin t

wher e the y ca n alway s serv e a s acceptabl e substitute s for

traditiona l studie s entailin g lon g termin vivo exposures
. I n som e instances , th e shor t ter mtest s ma y revea l potentia l hazard s withou t providin g sufficien t

informatio n t o determin e th e longe r

ter mconsequence s of th e observe deffect s o r

th e exten t

t o whic h the y represen t

significan t

publi c healt h o r welfar e risks. T o obtai n mor e definitiv e information , test s of longe r duratio n ma y sometime s b e needed

. Fo r example , ahighe r

orde r reproductive / developmenta l stud y woul dtak e clos e t o ayear , chroni c toxicit y test s might requir e on e t o tw o years , an d carcinogenesi s migh t

no t b e observabl e unti l th e lat e stage s of

atwo

- t o three

yea r experimenta l exposure
. Th e additiona l tim e require dfor tes t vehicl e mileag e accumulation

. Tie r 1 an d2 assessments , protoco l development , stud y set-up , an dresult s evaluatio n woul deffectivel y preclud e submissio n withi n th e prescribe dthre e years
. Therefore , EP

A ha s accommodate d th e tim e frame se t

forth i n sectio n 211(e ) wit h th e objective s o f

sectio n 211(b ) b y usin g atiere dapproac h t o testing

. Dat a prescribe dunde r

Tier s 1 an d2 woul db e require dt o b e submitte dwithi n thre e year s of th e effectiv e dat e of

th e rul e for existin g products , an dprio r t o receivin g registratio n for

ne w products

. O n th e basi s of suc h information , EP

A woul d determin e if

furthe r testin g wer e neede d unde r Tie r 3 t o asses s th e attendan t risks. I f Tie r 3 testin g wer e required , for eithe r ne w o r existin g product s (o r groups) , registratio n woul db e granted , bu t woul db e conditione dupo n satisfactor y complianc e wit h th e Tie r 3 dat arequirement s accordin g t o a timetabl e determine db y EP A t o b e appropriat e t o thes e requirements

. I f additiona l testin g wer e neede donl y t o mak e u p fo

r deficiencie s i n informatio n conten t o r testin g techniqu e relate dt o Tier s 1 an d2 , the n th e origina l three

yea r tim e frame woul dstil l b e i n force

. Notwithstandin g th e grantin g o f a registration , i

f EP A determine dtha t

a fuel o r additiv e wa s likel y t o presen t a substantia l risk

t o th e publi c healt h o r welfare , the n EP

A coul dinvok e availabl e regulator y authorit y unde r othe r Federa l law , includin g CA A sectio n 211(c ) o r

applicabl e section s of TSCA

. F. Scope of

Welfare Effects Evaluation Sectio n 211(b)(2)(B ) state s tha t th e Administrato r

ma y requir e manufacturer s t o furnis h "reasonabl e an dnecessary " informatio n fo r determinin g "th e exten t

t o whic h (fuel an dfue l additive ] emission s affec t th e publi c healt h o r

welfare"

. Th e term "welfar e effects " refer s generall y to th e impac t whic h ai r

pollutio n produce db y moto r vehicl e fuel s an dfuel additive s ma y hav e o n th e environment , an d encompasse s abroa drang e o f effect s o n aquati c an dterrestria l ecosystems , cultivate dcrop s an dothe r vegetation , natura l an dman-mad e materials , wildlife , an dstratospheri c ozone
. Ai r pollutio n effect s o n th e publi c welfar e als o includ e importan t

environmenta l concern s suc h a s noxiou s order s o r visibilit y impairment , whic h ma y detrac t fromhuma n well-bein g whil e no t representin g specifi c danger s t o huma n health

. A full assessmen t

of th e welfar e effect s o f mobile-sourc e ai r

pollutio n woul dnee dt o tak e int o consideratio n a larg e numbe r

of comple x an d interrelate dfactors : th e residenc e time

. o f fuel an dadditiv e emission s i n th e air , th e chemica l reaction s of th e emission s with othe r

ai r pollutants , th e dispersio n an ddepositio n of

th e emission s an d thei r atmospheri c b y products , th e abilit y o f animal s an dplant s t o bioconcentrat e thes e substances , an d th e specifi c consequence s t o variou s ecosystem s an dt o th e public' s well

being

. Suc h avenue s o

f investigatio n ar e extremel y importan t

t o ou r genera l understandin g of

th e causatio n an d effect s of ai r pollution

. Futur e scientifi c stud y i n thes e area s wil l b e critica l i n guidin g th e developmen t

of genera l policie s an deffectiv e regulator y approache s fo r

reducin g th e environmenta l risk s of

ai r pollution

. However , a t

th e presen t

time , EP A propose s no t

t o includ e laborator y testin g fo r

welfar e effect s i n th e requirement s o f

th e fuel an dadditiv e registratio n program
. Excep t fo r stipulatin g tha t

welfar e effect s requirement s shoul db e "reasonabl e an d necessary" , sectio n 211(b ) give s EPA th e discretio n t o determin e th e scop e of th e assessmen t

In contras t

t o th e provision s regardin g healt h effects , th e statu e doe s no t specificall y requir e testin g t o b e don e t o evaluat e th e effect s of fuel s an d additive s o n th e publi c welfare , an d doe s no t mandat e specifi c endpoint s for welfar e effect s assessment

. A t th e presen t time , scientifi c experienc e an d laborator y screenin g method s i n thi s comple x are aar e mor e limite dtha n i n th e are ao f

healt h effects

. Furthermore , othe r EP A program s ar e activel y involve di n researchin g an dcontrollin g mobil e an dstationar y sourc e contribution s t o majo r

ai r pollutio n problem s suc h a s tropospheric / stratospheri c ozone , globa l warming , an daci drain

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Fo r thes e reasons , EP A plan s t o addres s th e are ao f

welfar e effect s usin g approache s othe r

tha n biologica l testing

. Unde r thi s proposal , welfar e effect s requirement s woul dinclud e emissio n characterization , literatur e research , an d modeling/analyti c methods

. A s previousl y discussed , Tie r 1 require s responsibl e producer s t o conduc t chemica l speciatio n procedure s t o identif y th e emissio n product s generate d b y fuel s an dadditives

. Thes e procedure s wil l yiel da n inventor y o f potentia l harmfu l ai r

pollutant s whic h ma y hav e significan t

impact s o n th e genera l environmen t

an dpubli c welfar e a s wel l a s o n th e publi c health

. Secondly , Tie r

1 include s athoroug h literatur e searc h fo r

existin g health

relate dinformatio n abou t th e emission s o f fuel s an dadditives

. Thi s requiremen t wil l b e widene dt o encompas s availabl e scientifi c literatur e o n welfar e effects , including , bu t

no t necessaril y limite dto , th e exposur e an drespons e o f plant s an d animal s t o emissions , th e potentia l fo r bioaccumulation , an dth e concentratio n an dpersistenc e o f

th e emissio n product s i n th e air , soil , an dwater

. A searc h o f database s o n environmenta l toxicit y (aquati c an dterrestrial ) wil l b e include d i n thi s requirement

. Finally , th e modelin g requirement s o f Tie r 1 wil l includ e analysi s o f

th e environmenta l partitionin g an dfat e o f fue l an dadditiv e emissio n product s an dth e potentia l fo r aquati c an dterrestria l ecosyste m exposure
. A s aresul t

o f thes e expande d Tie r 1 activites , EP A woul dexpec t t o obtai n usefu l summarie s an danalyse s o f existin g dat ao n th e welfar e effect s o f fue l an dadditiv e emissions

. While , a t

thi s time

. EP A i s no t proposin g t o requir e biologica l testin g fo r welfar e effects , comment s ar e requeste do n th e nee dfo r an dfeasibilit y o f includin g suc h test s i n th e progra m requirements

. T o b e mos t useful , suc h comment s shoul dinclud e specifi c issue s t o b e addresse di n possibl e welfar e effect s testin g an dpractica l apporoache s fo r

examinin g thes e issue s withi n th e contex t

o f th e registratio n program
. On e alternativ e i s t o retai n th e optio n o f imposin g welfar e effect s testin g requirement s a t th e Tie r 3 leve l whe n th e outcom e o f

Tie r 1 demonstrate s bot h significan t environmenta l toxicit y an dexposur e potential

. Th e criteri afo r suc h decision s woul db e simila r

t o thos e use dfo r makin g health-relate dTie r 3 decisions

. Thus , Tie r

3 testin g fo r

welfar e effect s migh t b e require di f

th e environmenta l partitionin g an dexposur e analysi s reveal s th e potentia l fo r broa dexposur e a t concentration s tha t

ar e likel y t o pos e athrea t t o sensitiv e plant s an danimals

. If thi s alternativ e wer e adopted , Tie r 3 welfar e effect s testin g woul db e determine db y EP A o n acase-by-cas e basis

. Numerou s protocol s ar e available

. Endpoint s o f

concer n fo r

aquatic , mammalian , an davia n toxicolog y migh t include , bu t

ar e no t necessaril y limite d to , letha l concentrations , effect s o n growt h an dreproduction , an d bioaccumulation

. Plan t toxicologica l endpoint s migh t

includ e growth , yield , reproduction , frui t

quality , an dtissu e damag e o r

loss

. Th e exposur e treatment s fo r

suc h test s woul db e administere da t

expecte denvironmenta l concentrations

. Specifi c Tie r

3 tes t requirement s woul db e tailore dt o evaluat e th e potentia l environmenta l problem s identifie di n Tie r

1

. Fo r example , if

th e Tie r 1 modelin g result s indicate dtha t toxi c emission s partitione dt o ai r o r soi l an dpose darisk

t o vegetation

. Tie r

3 test s o n seedlin g vigor , lif e cycle , growt h an dreproduction , an dbioaccumulatio n coul db e require dt o quantif y th e risk

. Similarly , i f

th e pollutant s partitione dt o water , test s relatin g t o fathea dminno w growth , reproduction , bioaccumulation , mortality , o r

othe r appropriat e concern s woul db e required

. Commen t o n thi s possibl e approac h an dothe r alternative s i s requested

. IV

. Groupin g Syste mfo r Fuel s an dFue l Additive s A. Background

and Objectives Sectio n 211(e ) provide s anumbe r o f mechanism s b y whic h EP A ca n reduc e th e cost s an dburden s o f complianc e wit h th e registratio n requirement s se t fort h i n sectio n 211(b)

. I n particular , sectio n 211(e)(3)(B ) permit s th e Administrato r

t o "provid e fo r

cost

sharin g wit h respec t

t o th e testin g o f

an y fue l o r fue l additiv e whic h i s manufacture do r

processe db y tw o o r mor e persons , o r

otherwis e provide , fo r share dresponsibility " s o tha t th e progra mrequirement s ca n b e me t withou t duplicatio n o f

effort

. I n accordanc e wit h thi s provision , EP A intend s t o establis h agroupin g syste m whic h woul dpermi t

manufacturer s o f simila r fuel s an dfue l additives , o n a voluntar y basis , t o poo l thei r resource s an deffort s i n satisfyin g th e registratio n requirement s describe di n thi s NPRM

. Th e group s define db y EP A i n th e fina l rul e (unles s modifie db y subsequen t rulemakings ) woul db e th e onl y group s permitte dfo r

satisfyin g th e requirement s o f th e program
. T o thi s end , propose dcriteri ahav e bee n develope dfo r

sortin g individua l fuel s an dadditive s int o group s o f relate dformulation s base do n similaritie s i n thei r

chemical/physica l composition

. Th e fuel s an dadditive s withi n eac h grou p ar e expecte dt o hav e simila r emissio n characteristic s an d thu s essentiall y th e sam e genera l activit y wit h respec t

t o thei r potentia l effect s o n th e publi c healt h an dwelfare

. Therefore , chemica l o r toxicologi c informatio n associate dwit h individua l member s o f

agive n grou p ca n reasonabl y b e generalize dt o al l fuel s an dadditive s i n th e group , an dtest s perfome do n selecte drepresentative s ca n b e considere dvali dfo r th e grou p a s awhole

. Whil e eac h produce r

o f afue l o r additiv e woul dstil l b e hel dindividuall y accountabl e fo r

complianc e wit h th e registratio n program , th e groupin g syste mwoul dprovid e a n opportunit y fo r meetin g th e health/welfar e evaluatio n requirement s i n associatio n wit h manufacturer s o f

simila r products

. Participatio n i n th e fue l an dfue l additiv e group s woul db e strictl y voluntary , an dany
. manufacture r coul d choos e t o fulfil l th e requirement s o n a n independen t

basis

. Thos e wh o chos e t o tak e advantag e o f

th e groupin g opportunit y woul db e abl e t o shar e thei r plannin g efforts , researc h capabilities , an dfinancial resource s i n satisfyin g th e information-gatherin g an dtestin g requirement s o f

th e program
. T o satisfy requirement s fo r

chemica l an d biologica l testing , th e require dtest s woul db e don e o n on e o r mor e formulation s selecte dt o represen t th e group , rathe r

tha n bein g repeate dfo r eac h o f th e fuel s an dadditive s i n th e group
. Th e result s o f

th e test s o n th e grou p representative(s ) woul db e submitte djointl y fo r

al l member s o f

th e group , wit h applicabl e cost s t o b e share db y th e respectiv e manufacturers

. Manufacturer s wh o questione dwhethe r th e result s obtaine dfo r thei r group' s representative(s ) wer e vali dfo r thei r ow n product s coul dconduc t confirmator y test s o n thei r product s o n a n independen t

basi s an da t

thei r ow n cost

. However , unti l suc h independen t tes t result s wer e mad e availabl e t o EPA , th e origina l result s submitte do n behal f o f th e grou p woul db e considere dvali d fo r al l membe r

products , an dcoul db e applie db y EP A i n ris k assessmen t

an d risk managemen t

unde r CA A sectio n 211(c)

. Th e groupin g syste mfo r fuel s an d additives , i s expecte dt o provid e a numbe r o f benefit s t o th e producer s an d blender s wh o ar e responsibl e fo r registration , a s wel l a s increasin g th e efficienc y an dfunctionalit y o f th e registratio n progra mitself

. Th e primar y objectiv e o f

th e groupin g syste mi s t o maximiz e th e efficienc y o f th e progra m t o th e public , th e manufacturers , an dP.1 8

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EP A First , th e groupin g syste mwil l reduc e th e overal l cost s of th e registratio n progra mb y avoidin g th e unnecessar y generatio n an dsubmissio n o f essentiall y redundan t

informatio n b y individua l manufacturer s with simila r products

. I n addition , b y reducin g th e numbe r o f individua l formulation s tha t wil l b e subjec t

t o testing , th e groupin g syste mi s expecte dt o eas e th e pressur e an ddemand s o n scarc e laborator y capacity

. Grou p submission s o f tes t result s an dothe r

registratio n informatio n will als o decreas e th e volum e of material s whic h EP

A mus t revie w an dprocess
. Th e followin g section s explai n th e logical approac h an dfunctiona l rational e for

th e propose dgroupin g syste man dindividua l grou p definitions

. Rule s regardin g th e appointmen t o f grou p representative s fo

r healt h effect s testin g ar e als o presented

. Followin g thes e sections , issue s relatin g t o th e practica l implementatio n o f th e groupin g syste mar e discussed

. B. Grouping System Rationale 1

. Emission s vs
. Ra w Produc t Basi s Becaus e th e informatio n an dtestin g provision s o

f th e registratio n progra m ar e focuse do n ai r

pollutio n effects , th e fuel/additiv e group s woul dideall y b e define daccordin g t o th e emissio n product s o

f th e fuel s an dadditive s rathe r tha n th e chemica l compositio n o f th e ra w (uncombusted ) fue l an dadditiv e formulations

. Unfortunately , th e emission s dat aneede dt o defin e an d carr y ou t a n emissions-base dgroupin g syste mwil l no t

b e availabl e unti l th e final rul e relate dt o thi s NPR M ha s bee n implemente dan dth e ne w registratio n requirement s hav e bee n complete db y fue l an dadditiv e producers

. Thus , th e grouping s presente di n thi s proposa l hav e bee n define daccordin g t o characteristic s o

f th e ra w fuel s an d additives

. EP

A believe s thi s t o b e a reasonabl e approach , base do n th e principl e tha t

simila r ra w formulation s ar e expecte dt o generat e similar emissio n product s and , furthermore , tha t th e variabilit y whic h ma y exis t betwee n simila r fuel s an dadditive s wil l b e reduce db y th e proces s o f combustion

. Comment s ar e requeste do n th e validit y of usin g ra w produc t

characteristic s a s th e fuel/additiv e groupin g criteri afo r thi s emissions-base dtestin g program an dth e adequac y o

f thi s groupin g approac h for

evaporativ e a s wel l a s combustio n emissions

. I

f subsequen t informatio n indicate s tha t th e original grouping s ar e inadequate , EP A reserve s th e autiiorit y t o modif

y the mt o bette r reflec t similaritie s i n emissio n characteristics

. In addition , th e groupin g syste mwil l b e update da s necessar y t o accommodat e unanticipate dfue l and/o r additiv e formulation s whic h ma y b e introduce di n th e future

. Suc h change s woul db e implemente db y appropriat e rulemakin g procedures

. 2

. Fuel/Additiv e Relationship s Becaus e al l fuel producer s o r blender s an dal l additiv e producer s ar e individuall y responsibl e for registerin g thei r products , th e possibilit y of duplicativ e testin g fo

r relate dfuel s an d additive s i s aproble minheren t t o th e registratio n program
. Registere dfuel formulation s nearl y alway s contai n a Complemen

t o f "bulk " additives , includin g performanc e boosters , detergents , rus t

inhibitors , an dothe r agents

. In fact , th e basi c registratio n informatio n submitte dfo r mos t existin g fuel s ha s typicall y include dalis t of man y alternativ e "substantiall y similar " additive s withi n eac h purpose-in-us e category , an y o

f whic h ma y b e containe di n variou s formulation s of th e commerciall y distribute dfuel

. At th e sam e time , thes e bul k

additive s mus t als o b e separatel y registere db y thei r origina l producers , an dar e subjec t t o th e sam e health/welfar e effect s evaluatio n procedure s tha t th e relate d fuel s mus t

undergo

. I n meetin g th e requirement s of

thi s NPRM , eac h bul k additiv e mus t

b e mixe dwit h a n associate dfue

l prio r t o generating ' emission s for

testing

. T o th e exten t

tha t th e resultin g additive/fue l mixtur e i s similar t o existin g formulation s of fuel s (wit h thei r bul k additiv e components) , th e healt h effect s test s conducte do n th e emission s of

th e additive/fue l mixtur e woul db e duplicativ e of

existin g o r

ne w test s conducte do n th e relate dfuel s themselves

. Simila r overla p exist s fo

r aftermarke t additive s whic h ar e "substantiall y similar " t o thei r

respectiv e fuels

. A s i n th e cas e of

bul k additives , aftermarke t additive s mus t

b e mixe dwith th e appropriat e fuel prio r

t o generatin g th e emission s whic h wil l b e subjec t t o testin g unde r

thi s program
. I

f th e compositio n o

f th e additive/fue l mixtur e closel y resemble s tha t

o f th e fuel alone , testin g effort s fo

r th e additiv e an dth e relate dfue

l formulatio n wil l b e redundant

. Th e likelihoo dof redundan t effort s i s increase db y th e fac t tha t i t i s th e fuel/additiv e emission s rathe r tha n th e ra w fuel s an dadditive s whic h ar e subjec t t o th e propose dtestin g requirements

. T o avoi dthes e potentia l duplicatio n problems , th e propose dgroupin g syste m doe s no t requir e closely-relate dfuel s an dadditive s t o b e segregate dint o separat e groups
. Whe n th e combinatio n o f a n additiv e an dit s respectiv e fuel result s i n amixtur e tha t i s essentiall y th e sam e a s typica l commercia l formulation s o f

tha t fuel , the n th e additiv e an dassociate dfuel s ar e groupe dtogether

. Thus , th e producer s of th e fuel s an dth e relate dadditive s ca n fulfil l thei r individua l registratio n responsibilitie s throug h jointly

supporte dtestin g of

on e o r mor e formulation s representativ e p f thei r grou p rathe r

tha n throug h duplicativ e independen t

efforts

. Tha t

is , th e requirement s fo

r additive s whic h ar e registere da s par t

of afuel formulatio n ca n b e me t

i n conjunctio n wit h th e fuel producers

. Furthermore , othe r bul k o r aftermarke t

additive s whic h hav e essentiall y th e sam e chemica l makeu p a s additiv e component s o f fuel formulation s ca n als o mee t thei r requirement s i n conjunctio n with thes e fuel products

.

. B y groupin g simila r

fuel s an d additive s together , th e propose d groupin g schem e als o avoid s th e nee dt o defin e eac h generi c produc t o r produc t componen t

arbitraril y a s eithe r

a"fuel " o r a n "additive"

. Thi s proble mwoul d otherwis e aris e whe n agive n substanc e (o r mixture ) ca n serv e a s eithe r afuel o r a n additive

. A goo dcas e i n poin t

i s methanol

. Methano l ca n functio n a s a "substantiall y similar " additiv e t o unleade dgasolin e or , a t

highe r concentrations , a s th e oxygenatin g additiv e agen t

i n "reformulated " gasolin e o r

diese l fuels

. O n th e othe r hand , ther e ar e dedicate dmethanol

fuele dvehicle s a s wel l a s variably

- an d flexibly-fuele dvehicle s whic h ca n mak e us e of methano l a s thei r

basi c propellant , i n suc h for

ma s 100 percen t methano l fue

l (M100) o r

fuel compose d o f 8 5 percen t

methano l an d1 5 percen t gasolin e (M85)

. Th e approac h take n i n th e developmen t

o f th e propose dgroupin g syste mrecognize s tha t

fue l an dadditiv e formulation s ar e comple x mixture s o f varyin g proportion s rathe r tha n pur e chemica l substances

. Th e propose d groupin g syste mseek s t o categoriz e fue l an dadditiv e product s accordin g t o thei r expecte din-us e combinations

. T o th e exten t possible , i t

doe s no t mak e groupin g decision s base dupo n sometime s artificia l distinction s betwee n fuel s an dadditives

. Thi s categorizatio n proces s i s furthe r explaine di n th e nex t

section

. 3

. Groupin g Approac h Th e basi c conceptua l framewor k fo r th e propose dgroupin g syste mi s illustrate di n Figur e 2

. I n essence , EP A ha s specifie dseve n broa d"fuel families " an dthre e genera l "formulatio nP.1 9

1318 4 Federa l Registe r/ Vol

. 57 , No

. 7 3 /

Wednesday , Apri l 15 , 199 2 / Propose dRule s
classes

. Th e criteri awhic h defin e th e formulatio n classes " ar e use dt o subdivid e th e fuel familie s int o aserie s o f "fuel/additiv e categories. " Anothe r wa y t o vie w thi s relationshi p i s i n th e for mof across-tabulation , a s show n i n Figure 3

. Here , th e fue

l familie s serv e a s column heading s an dth e formulatio n classe s describ e th e rows
. Th e resultin g combination s o

f fuel familie s an d formulatio n classe s (i.e. , th e boxe s i n Figur e 3 ) ar e th e fuel/additiv e categories

. Withi n eac h category , EP A ha s develope dcriteri afo

r furthe r subdividin g th e product s int o "fuel / additiv e groups"

. Thes e group s ar e th e workin g unit s o f th e groupin g system : i t i s amon g th e member s o

f th e fuel / additiv e group s tha t

cooperativ e evaluatio n an dtestin g effort s ca n b e pursue dusin g designate dgrou p representatives

. Thi s conceptua l framewor k provide s som e importan t

practica l benefits

. First , i t avoid s th e nee dt o anticipat e an d attemp t t o defin e al l o

f th e possibl e fue

l an dadditiv e group s whic h might b e required

. Instead , generi c rule s fo r categorizatio n an dgroupin g ar e proposed , an dspecifi c fuel/additiv e group s ar e create di n respons e t o th e produc t component s encountered

. Th e propose dframework

shoul dals o facilitat e th e manufacturer' s tas k o f assignin g agive n fue

l o r additiv e t o th e appropriat e group
. Th e firs t ste p woul d entai l th e selectio n of

th e applicabl e fue

l family an dformulatio n clas s fo r th e produc t accordin g t o criteri adiscusse d below

. Thes e selection s woul ddefin e th e prope r

fuel/additiv e categor y fo r th e product

. Criteri awithi n eac h categor y woul dthe n b e use dto determin e th e appropriat e grou p assignment

. After th e grou p ha dforme dan darrangement s mad e for cooperativ e testin g efforts , applicabl e criteri awoul db e applie dt o selec t arepresentativ e o

f th e grou p t o b e use di n group-sponsore dtesting

. BILLIN G COO E 8560-50- M

## Figure 2 : Fue l / Additive Classificatio n Hierarchy
Conventiona l 

## Unleade d Gasolin e Leaded Gasolin e Diesel

Alternativ e 

## Methanol Ethano l Methan e (CNG , LNG ) Propan e (LPG ) - —Fuel Familie s X Formulatio n (.'lasses Baselin e Non-Rust-lin

e Atypical

Fue l / Additive Categorie s

Fue l / Additive Testin g Group s

Group Rep-esentative s 1. 

### o .
7.

-t


### < o

v l 

### p

C D . Q. S J C D C O 

### a . 03 • <
> • a

c o CD N J

o • a o c a C D 

### a. J C 

### c

_ C D C O BILLIN G COO E 6560-50- C

U C SP.2 1

1318 6 Federa l Registe r / Vol

. 57

. No

. 7 3 /

Wednesday , Apri l 15 , 199 2 / Propose dRule s

FIGUR E 3.—FUEL/ADDITIV E CATEGORIE S

Formulatio n classe s

(1 ) Baselin e formulations

.

(2 ) Non baselin e formulations

.

(3 ) Atypica l formulations

. "Conventional " fue l familie s

Unleade d gasolin e
(A) Baselin e unleade d

. gasolin e category
. On e grou p

. represente d b

y unleade d bas e fuel

. V Non-baselin e unleade d gasolin e category
. -Groupe d accordin g t o presenc e of non-baselin e factors

. Atypica l unleade d gasolin e category
. Groupe d accordin g t o atypica l element s an d othe r characteristics

. Leade d gasolin e
(B ) Baselin e leade d gasolin e category
. On e grou p represente d b

y leade d bas e fuel

.

Non-baselin e leade d gasolin e category
. Grouped accordin g t o presenc e o

f non-baselin e factors

. Atypica l leade d gasolin e category
. Groupe d accordin g t o atypica l element s an d othe r characteristics

. Diese l
(C ) Baselin e diese l category
. On e grou p represente d b

y diese l bas e fuel

.

Non-baselin e diese l category
. Groupe d accordin g t o presenc e o

f non-baselin e factors

. Atypica l diese l category
. Groupe d accordin g t o atypica l element s an d othe r characteristics

. Methano l

(>=50%MeO H BY VOL ) (D ) Baselin e methano l category. ' Two groups (M96 - M10 0 an d M50 - M95 ) represente d b

y M10 0 an d M8 5 bas e fuels

. Non-baselin e methano l category
. Groups TB A

Atypica l methano l category
. "Alternative "

Ethanol( > =50 % EtO H B Y VOL )

< E » Baselin e ethano l category
. Two groups (E96 - E10 0 an d E50 - E95 ) represente d .b

y E100andE8 5 bas e fuels

. Non-baselin e ethano l category
. Group s TB A

Atypica l ethano l category
. Group s TB A fue l familie s
Methan e (CNG , LNG ) (F ) Baselin e methan e category
. Two groups (CN G an d LNG ) represente d b

y CN G an d LN G bas e fuels

. Non-baselin e methan e category
. Groups TB A

Atypica l methan e

- category
. Propan e (LPG )
(G ) Baselin e propan e

- category
. On e grou p represente d b

y LP G bas e fuel

.

Non-baselin e propan e category
. Group s TBA

.

Atypica l propan e category
. Group s TBA

.

"Eac h categor

y contain s on e o r mor

e fuel/additive groups . Heart h effect s testin g informatio n i s require d fo r eac h suc h fuel/additiv e group .
Th e ke y parameter s an drelationship s withi n thi s groupin g framewor k ar e furthe r explaine dbelow

. Fuel families. Thre e "conventional " an dfou r "alternative " fue l familie s hav e bee n defined

. Eac h famil y consist s o f a constellatio n o f

fue l an dadditiv e product s whic h shar e basi c characteristic s i n regar dt o thei r chemical/physica l propertie s an d engine/vehicl e applicability

. Th e seve n fue l families , represente da s column s A

G i n Figur e 3 , are : (a ) Unleade dgasoline , (b ) leade dgasoline , (c ) diesel , (d ) methano l (containin g a t leas t 5 0 percen t methano l b y volume) , (e ) ethano l (containin g a t

leas t 5 0 percen t

ethano l b y volume) , (f

) methan e (i.e. , compresse dnatura l ga s an dliquefie d natura l gas) , an d(g ) propan e (i.e. , liqui d petroleu mgas)

. A s show n i n Figur e 3 , th e unleade dgasoline , leade dgasoline , an ddiese l familie s ar e regarde da s th e "conventional " fue l families , whil e th e remainin g fou r

ar e referre dt o a s th e "alternative " fue l families

. _ EP A expect s t o defin e additiona l fue l familie s i n th e futur e a s th e nee darises

. Fo r example , hydrogen-base dfuel s hav e no t bee n include di n th e curren t framewor k

becaus e moto r

vehicl e hydroge n fuel s an dcorrespondin g hydrogen-fuele dengine s ar e no t expecte dt o b e commerciall y availabl e fo r severa l years
. However , EP A request s comment s abou t th e possibl e nee dfo r hydroge n o r

othe r additiona l fue l familie s a t

thi s time

. A s note dabove , afue l famil y ha s bee n define dfo r

leade dgasolin e an d associate dadditives

. However , . provision s i n th e 199 0 Amendment s t o th e Clea n Ai r

Ac t prohibi t th e manufactur e o r

sal e o f ne w leaded

fuele dmoto r

vehicl e engine s beginnin g wit h mode l yea r

1993 , an dba n th e sal e o f leade dfuel s fo r

on-roa dus e a s o f Januar y 1,1996

. Thus , leade dfuel s an d additive s wil l b e phase dou t a t abou t th e sam e tim e tha t

dat awoul db e submitte dunde r

today' s propose drule

. I n vie w o f

th e upcomin g constraint s o n leade dproduct s an dth e timin g o f th e newregistratio n program' s implementation , commen t i s requeste d abou t di e nee dt o includ e thes e product s i n th e groupin g syste mor , indeed , i n th e ne w ristratio n progra mitself

. Consisten t

wit h th e previou s discussio n o n fuel-additiv e relationships , eac h fue l famil y include s no t onl y th e fuel s reference di n the

. nam e o f th e family , bu t

als o bul k

an d aftermarke t

additive s whic h ar e intende dfo r

us e i n suc h fuels

. Additive s whic h ca n b e use di n conjunctio n wit h mor e tha n on e typ e o f

fue l ar e propose d t o b e assigne dt o th e relevan t fue l famil y o f whic h th e mos t

gallon s o f

fue l ar e sol drelativ e t o th e othe r applicabl e fue l families

. A n alternativ e approac h woul d requir e suc h additive s t o b e teste di n associatio n wit h al l relevan t fue l families

. Commen t

i s requeste do n thi s alternative , includin g th e expecte dcost s an dbenefit s relativ e t o th e propose d approach. , EP A plan s t o develo p set s o f chemica l an dphysica l specification s whic h wil l represen t

theoretica l "industr y average " formulation s fo r

eac h define dfue l family

. Thes e generi c formulations , calle d"bas e fuels " (whic h wil l includ e a minima l additiv e package) , wil l functio n a s archetype s o f

th e fuel s an dadditive s i n thei r families

. Fo r

fue l additives , determinatio n o f

th e prope r

categor y an dgrou p i s t o b e base do n th e propertie s o f

th e additive/bas e fue l mixtur e tha t

woul dresul t

if th e additiv e wer e mixe di n it s family' s bas e fue l a t th e maximu mconcentratio n recommende db y th e additiv e manufacturer

. Moreover , prio r t o th e generatio n an dtestin g o f additiv e emissions , th e additiv e i s t o b e mixe di n it s bas e fue l a t

thi s concentration

. Test s conducte do n th e emission s o f th e bas e fue l woul dthe n serv e a s control s agains t which.test s o n th e emission s o f th e additive/bas e fue l mixtur e woul db e compared

. Bas e fuel s ar e als o propose d t o serv e a s representative s i n complianc e wit h testin g requirement s fo r som e fuel/additiv e groups
. Furthe r discussio n o n th e definitio n an dus e o f bas e fuel s i s presente di n sectio n V. E o f thi s NPRM

._P.22

_

Federa l Registe r

/ Vol

. 57 , No

. 7 3 /

Wednesday , Apri l 15 , 199 2 / Propose dRule s 1318 7

~~--r . .-.- ——-m~--rr • r. —" H' ~ * Formulation classes. Th e formulatio n classe s serv e t o subdivid e th e fuel s an d additive s i n eac h famil y int o categorie s accordin g t o thei r

similarit y t o th e bas e fuel(s ) specifie dfo r

th e family

. Displaye da s row s 1- 3 i n Figure 3 , thre e formulatio n classe s hav e bee n defined : "baseline" , "non-baseline " an d "atypical"

. (1 ) Th e baselin e formulatio n clas s (ro w 1 o f Figure 3 ) consist s o

f fuel s an d associate dfuel additive s whic h resembl e th e respectiv e bas e fuel s i n term s o f thei r elementa l compositio n an dthei r conformity wit h certai n quantitativ e limit s fo

r particula r elements , compounds , o r characteristics

. Baselin e formulation s i n th e unleade d gasolin e an ddiese l families , fo r example , woul dcontai n n o element s othe r tha n carbon , hydrogen , nitrogen, oxygen , an dsulfur , wit h limitation s o n di e allowabl e conten t

of oxygen , sulfur , an dothe r specifie dcomponents

. (2) Fuel s an dfuel additive s i n di e non
baselin e clas s (ro w 2 of

Figure 3 ) woul d contai n n o element s othe r tha n thos e allowe di n th e baselin e class ; however , the y woul dexcee dth e concentratio n limit s for certai n component s (o r

th e limit s o n othe r

physical/chemica l characteristics ) whic h wer e establishe d fo r th e baselin e class

. Fo r

fuel additives , thi s determinatio n woul db e base do n di e characteristic s of

th e mixtur e whic h woul dresul t

i f th e additiv e wer e mixe d i n th e appropriat e bas e fuel a t th e maximu mconcentratio n recommende d b y th e additiv e manufacturer

. (3 ) Th e "atypical " formulatio n clas s (ro w 3 of Figur e 3 ) consist s o f

fuel s an d fuel additive s whic h depar t furthe r fro m thei r respectiv e bas e fuel s i n tha t the y contai n element s othe r

tha n thos e presen t i n th e bas e fuel o r

excee d specifie dlimit s o n th e amoun t o f sulfur allowed

. Thus , i n th e unleade dgasolin e family , "atypical " formulation s woul d b e thos e containin g element s othe r tha n carbon , hydrogen , oxygen , nitrogen, an d sulfur an dthos e whic h excee ddi e maximu msulfur

conten t specifie dfor baselin e formulations

. Example s o f fuel s an dadditive s whic h woul dpotentiall y fal l int o th e "atypical " formulatio n clas s includ e thos e containin g compound s suc h a s methylcyclopentadienyl

manganese-tricarbony l (MMT) , organoceriu malkanediols , hexafluoro

e th y len e diamines , cobal t chlorid e an d othe r halogenate dmeta l oxides , zin c o r magnesiu msulfonates,'ferrou s o r coppe r sulfates , boro n succinamide , an dman y others

. Fo r th e mos t part , di e characteristic s whic h defin e th e "atypical " formulatio n clas s ar e relativel y distinct

. I n contrast , th e separatio n betwee n th e baselin e an d non-baselin e classe s i s les s obvious

. Th e distinctio n betwee n thes e tw o classe s depend s o n relativ e amount s o f certai n components , no t

th e absolut e presenc e o r

absenc e o

f suc h components

. Sinc e thes e component s ma y b e presen t

alon g acontinuu mo

f concentrations , i t

i s necessar y t o establis h cut-of

f point s whic h woul d defin e th e amount s considere d appropriat e t o th e baselin e an dnon
baselin e formulatio n classes

. I n regar dt o th e "conventional " fue l familie s (gasolin e an ddiesel) , EP A i s considerin g tw o basi c alternative s for distinguishin g th e baselin e an dnon
baselin e formulatio n classes

. Comment s ar e requeste dfromth e publi c o n th e advantage s an ddisadvantage s o f each

. Fo r eas e of reference , thes e tw o alternativ e approache s ar e terme d Optio n A an dOptio n B i n th e discussio n whic h follows

. Unde r Optio n A , baselin e an dnon
baselin e formulation s woul db e differentiate do n di e basi s o f thei r oxyge n an dmethano l content

. I n regar d t o oxygen , th e baselin e clas s woul db e restricte dt o formulation s havin g les s tha n 1. 5 weigh t

percen t of oxygen , whil e formulation s wid i 1. 5 percen t oxyge n o r mor e woul dfal l int o th e non-baselin e class

. Becaus e di e cut-of

f poin t o f 1. 5 percen t i s consisten t

wit h th e propose d minimu moxyge n requiremen t fo r reformulate dgasolines , al l reformulate d gasoline s woul db e assigne dtp di e non
baselin e formulatio n clas s unde r thi s option

. Th e baselin e constrain t

o n methano l conten t unde r Optio n A woul d correspon dt o th e methano l limitation s fo r "substantiall y similar " fuel s (5 6 F R 5352 , Februar y 11,1991) : 0. 3 percen t methano l b y volum e or , if accompanie d b y a n equa l volum e of

butano l o r

highe r molecular weigh t alcohol , u p t o 2.7 5 percen t methanol

. Formulation s whic h excee ddies e methano l limitation s woul dfal l int o th e non-baselin e class

. Optio n B woul dals o tak e oxyge n an d methano l conten t

int o accoun t

i n distinguishin g baselin e fromnon
baselin e formulations , bu t woul d establis h differen t

cut-of f point s for thes e factors

. Th e preliminar y baselin e limitation s o n bot h oxyge n an d methano l conten t

unde r Optio n B woul d correspon dt o th e limitation s o n thes e ' substance s i n di e "su b sim " rule : oxyge n woul db e limite dt o 2: 7 weigh t percen t an dmethano l woul db e subjec t t o th e limit s cite dabov e for

Optio n A

. However , fuel s an dadditive s whic h excee dthes e "sub-sim " oxyge n o r methano l limits , bu t

hav e bee n waivere d fro massociate dsectio n 211(f ) restrictions , woul dals o b e include di n th e baselin e formulatio n class

. Reformulate dfuel s woul dthu s b e considere dbaselin e formulation s unde r Optio n B

. Th e non-baselin e formulatio n clas s unde r

Optio n B woul dcontai n fuel s an dadditive s whic h ar e no t "su b sim " an dhav e no t

bee n waivere dunde r sectio n 211(f)

. (It

i s importan t

t o recogniz e tha t

an y fue l o r additiv e containin g a n "atypical " elemen t woul d b e assigne dt o th e "atypical " formulatio n class , whethe r o r no t i t ha s receive dasectio n 211(f

) waiver. ) Unde r bot h Option s A an dB , distinction s betwee n baselin e an dnon
baselin e formulation s ar e als o unde r consideratio n fo r

othe r fuel an dadditiv e characteristics , includin g limit s o n th e permissibl e level s o f

compound s suc h a s aromatics , olefins , an dPAHs , a s wel l a s physica l characteristic s suc h a s T9 0 (th e temperatur e a t

whic h 9 0 percen t

b y volum e of aliqui di s evaporated)

. EPA ask s for commen t o n whethe r formulation s wit h relativel y hig h level s of thes e substance s o r

characteristic s shoul db e assigne dt o th e non-baselin e clas s and , if

so , wha t specifi c cut-off

s shoul db e establishe dfo

r makin g th e baseline/non-baselin e determinations

. EP A als o ask s for

commen t o n whethe r th e baselin e oxyge n limitatio n i s appropriat e unde r

Optio n B , o r

whethe r tighte r restriction s shoul dapply , a s unde r Optio n A

. T o b e abl e t o asses s thes e option s an dalternatives , however , thei r potentia l implication s fo r th e fuel / additiv e categorie s an dgroup s mus t first b e understood

. Thes e relationship s ar e describe di n th e followin g sections

. Categories. A s mentione dpreviously , th e fuel/additiv e categorie s ar e equivalen t

t o di e "boxes " i n across
tabulatio n define db y th e intersectio n o f th e seve n fuel familie s an dth e thre e formulatio n classes

. Fo r

example , a s displaye di n th e firs t

column of

Figure 3 , th e unleade dgasolin e fuel famil y i s subdivide dint o baseline , non-baseline , an d"atypical " fuel/additiv e categorie s b y th e thre e formulatio n classes

. Som e o f th e categories , show n o n Figur e 3 hav e bee n define di n anticipatio n o f futur e produc t introduction s an dregistratio n designation s unde r

sectio n 211(a) , an d ma y no t hav e immediat e applicabilit y t o Ul e propose dne w registratio n program
. Th e precis e specification s of th e thre e categorie s i n tiie unleade dgasolin e fue l famil y wil l depen do n whethe r th e baselin e an dnon-baselin e formulatio n classe s ar e define db y Optio n A o r Optio n B

. Unde r

eithe r option , th e definitio n of

th e baselin e unleade d gasolin e categor y woul dincorporat e som e o f th e criteri awhic h defin e "substantiall y similar " products

. Fuel s an dadditive s i n th e baselin e unleade d gasolin e categor y woul d(1 ) contai n n o element s othe r

tha n carbon , hydrogen

.P.2 3

1318 8 Federa l Registe r / Vol

. 57 , No

. 7 3 /

Wednesday , Apri l 15

. 199 2 / Propose dRule s nitrogen , oxygen , and/o r

sulfur , i n th e for mo f hydrocarbons , aliphati c ethers , and/o r aliphati c alcohols , (2) contai n n o mor e tha n 0. 3 percen t

methano l b y volum e or , i

f accompanie db y a n equa l volum e of butano l o r

highe r molecular weigh t alcohol , u p t o 2.7 5 percen t methanol

. (3 ) contai n n o mor e tha n 1.00 0 pp msulfur , an d(4) mee t

applicabl e volatilit y clas s standard s publishe db y th e America n Societ y fo

r Testin g an d Material s (AST

M D4814)

. I f Optio n A wer e adopted , on e additiona l restrictio n woul dappl y t o fuel s an dadditive s i n th e baselin e unleade dgasolin e category : Thei r oxyge n conten t

woul db e limite dt o a n amoun t les s tha n 1. 5 weigh t

percent

. I

f Optio n B wer e adopte dinstead , tw o othe r specification s woul dapply

. First , oxyge n conten t

woul db e limite dt o 2. 7 weigh t percen t o r less

. Second , fuel s an d additive s whic h exceede dth e limitation s o n oxyge n o r

methano l conten t bu t receive dawaive r

unde r sectio n 211(f

) fo r thes e "non-sub-sim " characteristics , woul db e include di n th e baselin e category , a s lon g a s al l othe r baselin e criteri awer e me t Additiona l specification s woul dnee dt o b e establishe dfor

th e baselin e unleade d gasolin e categor y i f

restriction s wer e se t o n di e aromatic , olefin , o r PA H content , o r o n th e basi s of

T90

. Unlik e th e "su b sim " interpretiv e rule , th e specification s propose dfo r th e baselin e unleade dgasolin e categor y d o no t includ e -separat e criteri afo r fuel additives

. I n thi s program , classificatio n decision s fo

r additive s ar e t o b e base d o n th e propertie s of

th e respectiv e additive/bas e fiiel mixture

. Thus , th e criteri ause dfo

r sortin g fuel s int o categorie s an dgroup s ca n als o b e use d fo r additives

. Th e non-baselin e unleade dgasolin e categor y i s comprise do f

fuel s (an d additive/bas e fuel mixtures ) whic h fai l t o confor mt o th e baselin e designatio n becaus e thei r

oxyge n and/o r

methano l exceed s th e baselin e constraints

. Unde r Optio n A , thi s Categor

y woul dinclud e formulation s o f

a t leas t 5 0 percen t unleade dgasoun e blende dwid i methanol , ethanol

. methyl-tertiary-buty l ethe r (MTBE)

. ethly-tertiary-buty l ethe r (ETBE)

. and/o r

othe r alcohol s an d ethers , whe n th e tota l oxyge n conten t i s a t leas t 1. 5 percen t

Thus , th e non
baselin e categor y woul dinclud e reformulate dgasoline s a s wel l a s a numbe r o f formulation s whic h hav e previousl y bee n grante dwaiver s o f sectio n 211(f

) restrictions

. I n contrast , unde r Optio n B

. thes e reformulate dan d waivere dgasoline s woul dfal l int o th e baselin e category

. Th e non-baselin e categor y unde r

Optio n B would , fo

r di e mos t

par t includ e gasolin e formulation s with oxyge n o r

methano l i n exces s of waivere damounts

. Unde r eithe r option , th e non-baselin e categor y coul dcontai n additiona l fuel s an dadditive s i f th e othe r parameter s previousl y discusse d wer e als o include di n th e definitio n o f th e non-baselin e formulatio n class

. Th e thir do r

"atypical " categor y i n th e unleade dgasolin e fuel famil y include s fuel s an dadditive s whic h contai n element s othe r

tha n tiiose i n th e baselin e category

. Thus , th e "atypical " element s ar e thos e othe r

tha n carbon , hydrogen , nitrogen , oxygen , an dsulfur

. Sulfu r a t concentration s greate r

tha n 1,00 0 pp mi s als o considere dt o b e a n atypica l elemen t

I n man y instances , product s containin g thes e element s ar e "grandfathered " aftermarke t additive s whic h wer e allowe dt o b e registered , withou t consideratio n of

thei r possibl e emissio n contro l o r

othe r effects , prio r

t o th e enactmen t

of th e 199 0 CA A Amendments

. T o generat e th e emission s fromsuc h additive s fo

r subsequen t emissio n characterizatio n an dhealt h effect s testing , th e additive s wil l b e require dt o b e mixe dwit h th e bas e fuel designate dfo

r th e fuel family

. Th e result s obtaine dfo

r th e emission s of

th e additive/bas e fuel mixtur e will the n b e require dt o b e compare dt o contro l studie s conducte do n th e emission s o f th e bas e fue l alone

. Th e fuel/additiv e categorie s i n th e leade dgasolin e fuel famil y ar e conceptuall y similar

t o th e unle'ade d gasolin e categories

. Th e definitio n o f th e baselin e leade dgasolin e categor y woul d b e th e sam e a s tha t

fo r unleade d gasoline , excep t

tha t th e criteri awoul d includ e allowabl e lea dconten t an d typica l halogenate dlead-scavenge r compounds

. Th e non-baselin e leade d gasolin e categor y woul dinclud e product s whic h excee dth e baselin e limit s o n oxyge n o r

methanol

. Criteri afo r

th e baselin e diese l categor y woul dals o paralle l thos e specifie dfo

r unleade dgasoline , excep t tha t th e limi t o n sulfur conten t woul db e 0.0 5 weigh t

percen t instea do f

1.00 0 pp m an dth e applicabl e ASTM standar d woul db e ASTM D975

. However , th e definitio n adopte dfor

th e final rul e wil l depen do n th e suitablilit y for thi s purpos e o f

th e ne w "su b sim " criteri a no w unde r

developmen t

fo r diese l ' product s (se e advance dnotic e o f propose drulemaking , 5 6 F R24362 , Ma y 30,1991)

. Th e non-baselin e diese l categor y woul dcontai n product s whic h excee dth e applicabl e baselin e restrictions

. Potentially , thes e woul db e th e sam e a s "non-sub-sim " diese l fuel s an dadditives

. Th e "atypical " categorie s of leade dgasolin e an ddiese l product s woul dinclud e product s wit h element s othe r tha n thos e allowe di n th e respectiv e family' s baselin e categor y o r with sulfur

i n exces s o f

th e baselin e limitations

. Categorie s withi n th e "alternative " fue l familie s ar e show n i n column s D- G o n Figure 3

. Th e baselin e categorie s woul dcontai n typica l M100 an dM8 5 formulation s withi n th e methano l fuel family , E8 5 an dE10

0 formulation s withi n th e ethano l fuel family , compresse dan dliquifie dnatura l ga s formulation s withi n th e methan e fue l family , an dliqui dpetroleu mga s withi n th e propan e fuel family

. Ther e i s littl e prospectiv e informatio n regardin g "non

baseline " o r

"atypical " product s whic h ma y b e introduce di n thes e fuel familie s an di t i s possibl e tha t

thes e categorie s wil l initiall y b e empty

. Nevertheless , th e boundarie s betwee n th e baselin e an dth e othe r potentia l categorie s withi n thes e four fuel familie s mus t b e established

. EP

A i s considerin g variou s set s of

existin g an dpropose d criteri afor

thi s purpose , includin g draf t AST M standard s fo

r alternativ e fuel s an dcommercia l specification s for alternativ e fuel s propose db y th e Californi aAi r

Resource s Boar d (CARB). ' Som e of

thes e propose d specification s ar e summarize di n th e followin g paragraphs

. However , th e baselin e categor y definition s whic h EP A adopt s for

th e final rul e ma y var y from thes e proposals , dependin g o n th e final standard s an dspecification s promulgate db y thes e an dothe r organization s an dth e relativ e applicabilit y o f

an y "su b sim " criteri a for alternativ e fuel s whic h EP A ma y promulgat e i n th e interim

. Withi n th e baselin e methano l category

. M10

0 fuel s ar e propose dt o contai n aminimu mof

9 6 volum e percen t methanol

. U p t o 2 percen t b y mas s ma y b e compose dof

othe r oxygenat e compound s (e.g.

. othe r

alcohol s an d ethers ) an du p t o 2 percen t ma y b e compose dof

hydrocarbons

. Th e sulfur conten t pf M10 0 fuel , accordin g t o a pendin g ASTM proposal , woul db e limite dt o 10

0 part s pe r

millio n b y weigh t (ppmw)

. M8 5 fuel s woul dcontai n aminimu mo f

8 5 percen t

methano l b y volume

. Th e remainin g volum e woul db e compose do

f commercia l unleade d gasolin e unde r

th e CAR B proposal ; o r

of unspecifie dhydrocarbon s accordin g t o th e draf t ASTM standards

. CAR

B propose s amaximu msulfur conten t fo r

9 Francis , Stephen R

. Staf f Report : Initia

l Statemen to f Reason s fo

rRulemaking
. Publi c Hearin g t o Conside rAdoption o

f Specification s fo

r Alternative Fuel s fo

rMoto rVehicles
. Stat

e o f California Ai r Resource s Boar d (CARB)
. Stationar

y Sourc e Division
. Octobe r28.1991
.P.2 4

Federa l Registe r

/ Vol

. 57 , No. 7 3 /

Wednesday , Apri l 15 , 199 2 / Propose dRule s 1318 9
M8 5 o f 15 0 ppm w becaus e of

th e unleade dgasolin e componen t o f th e fuel , whil e a5 0 ppm w limi t i s propose d b y th e Moto r

Vehicl e Manufacturer s Associatio n for

certificatio n M8 5 fuel

. Al l baselin e methano l fuel s woul db e require dt o contai n aflame luminosit y additiv e fo r

safety reasons , du e t o th e virtua l invisibilit y o f

amethano l flame

. Th e allowabl e compositio n of thi s additiv e woul dnee dt o b e determine d fo r th e final definitio n o

f th e baselin e methano l category

. Specification s for

th e baselin e ethano l categor y woul dclosel y paralle l th e criteri afo r baselin e methano l fuels , excep t tha t th e ethano l mus t

b e denature dwit h commercia l unleade d gasolin e befor e bein g use di n moto r vehicl e fuels

. E1C

0 woul db e require dt o hav e aminimu mo f

9 2 volum e percen t ethano l (9 8 volum e percen t denature d ethanol) , wit h amaximu msulfur conten t of 10 0 ppmw
. E8 5 woul dconsis t of a minimu mof

8 1 volum e percen t

ethano l (8 5 volum e percen t

denature dethanol) , with sulfu r

conten t limite dt o 15 0 ppmw
. I n th e baselin e methan e category , compresse dnatura l ga s (CNG) an d liquifie dnatura l ga s (LNG ) differ onl y i n th e manne r

i n whic h the y ar e transporte dan dstored

. Otherwise , bot h CN G an dLN

G fuel s woul db e require d t o contai n a t

leas t 8 8 mol e percen t methane , wit h 8 mol e percen t ethan e allowed

. Iner t

gases , principall y CO : an dN 2 , coul dcompris e u p t o 5 mol e percen t o f th e fuel an d"othe r hydrocarbons " coul dmak e u p afurthe r 3. 5 mol e percent

. Liquifie dpetroleu mga s (LPG) , p r propan e gas , woul db e require dt o contain , a t

aminimum , 8 0 percen t propan e b y volume

. GAR B propose s tha t i t als o contai n amaximu mof 1 0 volum e percen t propene , whil e ASTM support s amaximu mof

5 volum e percent

. Th e limi t for butan e an dothe r

hydrocarbon s i s propose dt o b e 2. 5 volum e percen t an d th e sulfur conten t i s restricte dt o 12 3 ppmw
. Comment s an dsuggestions ar e requeste dregardin g tiie mos t appropriat e criteri afor

distinguishin g th e baseline , non-baseline , an datypica l categorie s withi n th e alternativ e fuel families

. A s EP

A acquire s edditiona l dat ao n alternativ e fuel an dadditiv e formulations , thi s informatio n wil l b e place di n th e docke t

an dmad e availabl e fo r publi c inspection.

. Groups. Th e fuel/additiv e group s ar e subdivision s of

th e fuel/additiv e categories , an drepresen t th e fina l leve l o f produc t classificatio n withi n th e groupin g system

. Thes e group s ar e th e actua l operatin g unit s o

f th e groupin g system

. Withi n eac h group , on e o r mor e formulation s will b e chose n t o represen t al l of th e membe r

product s i n complianc e wit h th e registratio n program' s testin g requirements

. Relate d cost s wil l b e share db y participatin g blender s an dmanufacturers

. Th e numbe r

o f group s define di n a particula r categor y o

f fuel s an d additive s depend s o n di e variabilit y amon g th e potentia l product s i n tha t categor y an dth e likelihoo dtha t thi s degre e of variabilit y woul dcaus e importan t difference s i n thei r

emissio n products

. Th e magnitud e o f expecte d variabilit y i n th e emission s o f differen t fuel s an dadditive s mus t

als o b e viewe d i n relatio n t o th e variation s tha t wil l inevitabl y b e introduce db y th e emissio n generatio n syste mitself

. A singl e fuel / additiv e formulatio n wil l yiel d somewha t

differen t emissio n product s dependin g o n th e vehicl e an dengin e use dt o generat e them , an dma y eve n diffe r whe n th e sam e vehicl e i s use d unde r differen t operatin g conditions

. Thus , absolut e precisio n i s no t alogica l goal

. Instead , th e objectiv e underlyin g th e grou p definition s i s t o sor t fuel s an d additive s togethe r

whe n i t i s reasonabl e t o assum e tha t

thei r emissio n product s woul db e essentiall y th e sam e o n a qualitativ e basis

. Give n thes e considerations , th e propose dgroup s an dgrou p representative s withi n eac h o f th e fuel / additiv e categorie s ar e describe di n th e followin g sections

. (a ) Groups within the baseline "conventional"

categories. EPA i s initiall y proposin g tha t

th e baselin e categorie s i n th e unleade dgasoline , leade dgasoline , an ddiese l fuel familie s (ro w 1 , column s A- C o n Figur e 3 ) eac h b e regarde da s equivalen t t o asingl e fuel/additiv e group
. EP

A furthe r propose s tha t

eac h of thes e group s b e represente di n require demissio n characterizatio n an dhealt h effect s test s b y th e bas e fuel designate dfor th e respectiv e fue l family

. Unde r thi s proposal , th e baselin e conventiona l fuel/additiv e group s woul db e ver y large , an deac h of

th e respectiv e bas e fuel s woul dpotentiall y b e use dt o represen t hundred s o f

products

. Thus , tw o alternativ e approache s ar e unde r consideration

. . Th e firs t alternativ e woul dretai n th e concep t o f asingl e grou p for

eac h baseUn e fuel/additiv e category , bu t woul dincreas e th e numbe r of representative s fo r

eac h suc h group
. Fo r example , th e baselin e unleade dgasolin e grou p might

b e represente db y thre e bas e fuels , correspondin g t o regular , mid-grade , an dpremiu mformulations

. Likewise , th e diese l grou p might b e represente db y bot h D- 1 an dD- 2 bas e fiiel formulations

. I n addition , appropriat e commercia l formulation s coul db e selecte da s representative s reflectin g extreme s i n aromatic , olefin , o r PA H content

. I

f th e baselin e categorie s an dgroup s wer e define d unde r Optio n B , consideratio n might als o b e give n t o th e designatio n of selecte doxygenate dfuel s a s additiona l grou p representatives

. I n practice , however , th e designatio n of mor e tha n on e representativ e pe r grou p woul dru n counte r

t o th e genera l approac h i n th e progra mtha t adequat e existin g informatio n fo r

an y produc t

i n a give n grou p ca n b e use dt o satisf y th e associate dtestin g requiremen t fo r al l product s i n th e group
. I

f adequat e testin g ha dpreviousl y bee n done , say , o h on e o f th e representative s o f

agroup , thes e tes t result s coul db e applie dt o al l product s i n th e group , includin g th e othe r representatives

. Therefore , full testin g woul dno t

b e require dfor

eac h representative

. Th e secon dalternativ e woul davoi d thi s resul t b y splittin g th e baselin e fuel / additiv e categorie s int o mor e tha n on e group
. Unde r

thi s approach , th e baselin e unleade dgasolin e categor y coul db e divided , say , int o thre e group s (regular , mid-grade , an dpremium ) an dth e diese l categor y int o tw o group s (D- 1 an dD-2)

. Othe r groups , base do n th e factor s previousl y discussed , woul dals o b e possible

. A correspondin g bas e fue l o r selecte dmembe r

produc t woul db e designate dt o serv e a s th e representativ e for

eac h group
. Thi s approac h woul drequir e di e submitta l of acomplet e se t

of tes t information , eithe r existin g o r

new , fo r eac h o f thes e classifications

. However , mos t .o f th e previou s testin g o n product s i n th e baselin e categorie s ha s mad e us e of regula r gaolin e an dD- 2 diese l fuels

. A s aresult , th e othe r

potentia l group s i n thes e categorie s woul dlargel y b e preclude dfromusin g existin g tes t dat a for complianc e wit h progra m requirements

. EP

A ask s for

commen t o n thes e variou s option s for definin g th e baselin e conventiona l fuel/additiv e group s an dthei r

representatives.

- (b ) Groups within the non-baseline "Conventional"

categories. EP

A propose s t o subdivid e th e non-baselin e categorie s o f

unleade dgasoline , leade d gasoline , an ddiese l product s (ro w 2 , column s A- C o n Figure 3 ) int o differen t workin g group s base do n th e specifi c compound(s ) presen t

i n th e formulation

. In th e non-baselin e unleade dgasolin e category , for

example , separat e group s ar e propose dfor

gasolin e formulate d wit h methano l alone , ethano l alone , MTB E alone , ETB E alone , an dothe r individua l alcohol s an dethers

. Product s containin g combination s o f oxygenat e compound s woul db e assigne dt oP.2 5

1319 0 Federa l Registe r / Vol

. 57 , No

. 7 3 /

Wednesday , Apri l 15 , 199 2 / Propose dRule s
additiona l groups , with separat e group s define dfor

eac h combinatio n presen t i n on e o r mor e produc t

formulations

. Amon g currentl y registere dfuel s an d fue l additives , EP

A estimate s tha t

thi s proposa l woul dproduc e 1 7 group s i n th e non-baselin e unleade dgasolin e category an don e grou p i n th e non-baselin e diese l category , assumin g Optio n A wer e use d t o defin e th e formulatio n classes

. Withi n eac h o

f thes e groups , th e membe r fuel o r additive/bas e fuel mixtur e containin g th e highes t tota l weigh t percen t of oxyge n woul dserv e a s th e grou p representative

. I n cas e o f "ties " withi n agive n group , th e propose dregulation s contai n decisio n •criteri afor

selectin g th e representativ e produc t base do n th e proportio n o f th e tota l oxyge n conten t

whic h i s contribute db y particula r oxygenat e compounds

. Th e propose dcriteri agiv e precedenc e t o oxygenat e compound s i n th e followin g order : (1 ) Methanol , (2 ) Ethanol , (3 ) Tert-buty l alcoho l (TB A o r GTBA) , (4) MTBE , (5 ) Tert-amyl-methyl-ethe r (TAME) , (6 ) ETBE , (7 ) Isopropanol , (8 ) Isopropy l ether , (9 ) Othe r alcohols , (10 ) Othe r ethers

. Som e woul dargu e tha t

th e group s propose dwithi n th e non-baselin e categorie s ar e s o narrowl y define dthat , i n som e cases , th e exhaus t emission s fromproduct s i n differen t group s wil l probabl y b e indistinguishable

. A t th e curren t time , EP A i s unawar e o

f detaile d emissio n speciatio n test s o n variou s oxygenate dformulation s whic h woul d suppor t thi s theory

. However , i t

might b e possibl e t o establis h programmati c mechanism s whic h woul dallo w som e group s t o b e collapse dfo r purpose s o

f studie s o n th e healt h effect s o f combustio n emissions , if

th e result s of speciatio n test s indicate dtha t th e emission s fromth e representativ e product s i n differen t

group s wer e th e same
. Suc h mechanism s woul dnee dt o includ e speciatio n result s o n th e emission s fro

masufficient

numbe r o f vehicle s tha t

objectiv e statistica l conclusion s coul db e reache dregardin g th e emission s variability

. Comment s an d suggestion s o n thes e issue s ar e welcome

. Dependin g o n th e final definition s adopte dfor

th e baselin e an dnon
baselin e formulatio n classes , th e non
baselin e categorie s ma y contai n fuel s an dadditive s with distinguishin g characteristic s othe r

tha n oxygenat e components

. A s mentione dpreviously , thre e suc h factor s unde r

consideratio n ar e aromatic , olefin , an dPA H content

. In thes e instances , th e definitio n o f group s an dgrou p representative s woul d follo w principle s simila r

t o thos e applie dabove

. T o us e aromati c conten t a s a n example , an dapplyin g th e principle s presente di n th e supportin g regulator y text , individua l compound s o f concer n woul db e groupe dseparately ; however , if

tw o compound s of

concer n wer e present , th e representativ e woul d b e tha t with th e greate r

proportio n o

f th e heavie r

weigh t aromatic s (e.g. , greate r weigh t give n t o nine-carbo n tha n seven-carbo n compounds)

. (c ) Groups within the "Atypical" gasoline and

diesel categories. Fo r

fuel s an dadditive s i n th e "atypical " gasolin e an ddiese l categorie s (ro w 3 , column s A- C o n Figure 3) , EP

A propose s t o defin e arelatively , larg e numbe r of distinc t group s accordin g t o th e element(s ) whic h cause dthes e product s t o b e categorize da s atypical

. Firs t separat e grouping s woul db e establishe d fo r an y singl e atypica l elemen t an dan y uniqu e combinatio n of

atypica l element s whic h occurre damon g th e product s i n eac h category

. Thes e grouping s woul d the n b e furthe r

subdivide daccordin g t o th e presenc e o r

absenc e o

f polymer s an dth e presenc e o r

absenc e o

f oxyge n i n a n amoun t

greate r tha n th e baselin e amount

. Fo r currentl y registere dfuel s an d additives , EP

A estimate s tha t

thi s approac h woul dresul t

i n 4 8 "atypical " unleaded-gasolin e group s an d4 7 "atypical " diese l groups
. Comment s ar e requeste dconcernin g thi s propose d groupin g schem e an dpossibl e alternativ e approaches

. Fo r example , commen t i s requeste do n th e necessit y o f establishin g separat e group s fo r eac h uniqu e combinatio n o

f "atypical " element s an dconditions , a s i s proposed

. Alternatively , i t

might b e possibl e t o defin e som e reasonabl e rule s o f precedenc e whic h woul dallo w product s containin g certai n combination s o f "aytpical " characteristic s t o b e groupe d with product s containin g onl y on e of thes e characteristics

. Suc h a n approac h woul ddecreas e th e tota l numbe r o f grouping s an dwoul dincreas e th e numbe r o f potentia l product s i n eac h group
. Suggestion s ar e als o welcom e i n regar dt o additiona l variable s (e.g. , aromati c conten t

o r th e presenc e o

f specifi c oxygenat e compounds ) whic h shoul db e take n int o accoun t i n definin g group s o f atypica l products , recognizin g tha t eac h ne w facto r

coul dincreas e th e numbe r an ddecreas e th e siz e of th e resultin g groups
. For eac h group , th e representativ e t o b e use di n satisfyin g th e group' s testin g requirement s i s propose dt o b e th e membe r produc t with th e highes t concentratio n o

f atypica l elements

. I

n cas e o

f ties , aproces s fo

r selectin g th e representativ e i s propose dwhic h woul d giv e precedenc e t o th e relevan t characteristic s i n th e followin g priorit y orde r (1 ) Tota l metals , (2 ) Tota l halogens , (3 ) Tota l o

f othe r atypica l elements , (4) Tota l oxyge n content , (5 ) Polyme r

content

. EP A ha s propose dtha t

th e representativ e b e selecte dt o reflec t th e highes t concentratio n o

f atypica l element s s o that , i

f subsequen t

test s ar e negative , thes e result s ca n safel y b e generalize dt o al l grou p members

. If , instead , th e representativ e wer e chose n t o reflec t th e averag e o r

media n concentratio n o

f atypica l element s amon g product s i n -th

e group , th e significanc e o

f negativ e tes t

result s woul db e unclea r

fo r grou p member s wit h highe r

concentration s of

atypica l characteristics

. In cas e aparticula r grou p contain s product s whic h generall y reflec t adistinc t

clusterin g o

f concentration s plus on e o r mor e product s with muc h highe r concentrations , th e associate d manufacturer s ma y choos e t o divid e th e grou p o n thi s basi s t o preven t adistan t "outlier " fromservin g a s th e representativ e fo

r all

. (d ) Groups within the baseline "Alternative"Categories. Withi n th e baselin e methano l category , EP A propose s t o establis h tw o fuel/additiv e groups
. On e grou p woul dinclud e M10 0 formulation s (containin g a t leas t 96% methanol ) an dwoul db e represente db y adesignate dM10

0 bas e fuel formulation

. Th e secon dgrou p woul d consis t o f methanol/gasolin e blend s containin g 50-96 % methanol

. Th e latte r grou p woul db e represente db y a designate dM8 5 bas e fuel , reflectin g th e expecte dpreponderanc e of end-us e formulation s i n thi s group
. Becaus e EP

A ha s littl e experienc e with formulation s i n th e ethanol , methane , an dpropan e fue l families , suggestions fromth e affecte dindustr y organization s ar e requeste di n regar dt o appropriat e number s o

f group s an d representative s for

th e baselin e categor y i n eac h o f thes e families

. A t

thi s time , EP A propose s t o defin e tw o group s withi n th e baselin e ethano l category , define di n paralle l to th e tw o methano l group s describe dabove

. Th e baselin e methan e categor y i s als o propose dt o contai n tw o group s (CNG an dLNG) , whileth e baselin e propan e categor y woul dconstitut e asingl e group
. Dependin g o n th e rapidit y with whic h product s i n thes e categorie s ar e introduce dint o th e marketplace , an dth e timetabl e fo

r implementatio n o

fP.2 6

expecte dregulation s requirin g th e registratio n of

thes e products , i t

may b e possibl e t o defin e baselin e ethano l (E8 5 an dE100) , CNG

. LNG

. an dLP G formulation s t o serv e a s th e respectiv e grou p representative s i n tim e fo r th e final rul e relate dt o thi s proposal

. Alternatively , i

f product s i n thes e group s ar e no t registere dunti l afte r

publicatio n of th e final rule , i t

ma y b e necessar y t o designat e th e firs t

commercia l fuel t o see k registratio n i n eac h grou p a s th e prospectiv e representativ e fo r simila r product s seekin g registratio n a t alate r time

. I n tha t

instance , technica l amendment s coul db e publishe d definin g th e specifi c produc t formulatio n criteri awhic h woul db e use dt o detennin e whe n producer s o f late r product s coul drel y o n th e testin g informatio n submitte dfo r th e first produc t i n satisfactio n o f

thei r ow n registratio n requirements

. A tim e limi t for th e initia l registrant' s righ t t o reimbursemen t

woul dals o nee dt o b e established

. Commen t

i s solicite do n thes e topics

. (e ) Groups within the "Non-Baseline" and "Atypical"

"Alternative" categories. Wit h respec t

t o product s whic h ma y fal l int o th e "non-baseline " an d"atypical " methanol , etiianol

. methane , an dpropan e categorie s (row s 2 an d3 , column s D- G o n Figure 3) , EP A mus t defe r th e devlopmen t

o f applicabl e group s unti l informatio n o n th e natur e o f thes e future product s become s available

. A s apractica l matter , suc h group s ar e likel y t o b e define di n respons e t o propose dne w produc t introduction s rathe r

tha n i n advanc e of thei r introduction

. A s describe dabov e i n regar dt o th e baselin e alternativ e fuels , th e firs t

manufacturer s o f

atypica l product s i n thes e categorie s t o satisf y th e testin g an dothe r

registratio n requirement s woul dhav e th e righ t t o see k reimbursemen t

frommanufacturer s o f othe r product s wh o wishe dt o rel y o n th e firs t manufacturer' s dat afo

r registerin g subsequen t

similar products

. EP A woul dwelcom e comment s o n thes e proposal s an do n alternativ e mechanism s for

definin g an d establishin g group s withi n thes e ne w fuel/additiv e categories

. 4

. Alternative s fo r

Grou p Responsibilitie s In th e approac h describe dabove , a designate drepresentativ e woul d represen t th e member s of

afuel / additiv e grou p i n complianc e wit h al l healt h effect s testin g requirements , includin g bot h th e Tie r

1 requirement s for chemica l speciatio n of

emission s an d th e biologica l testin g requirement s o f Tier s 2 an d3

. A n alternativ e approac h woul drequir e al l uniqu e fuel an d additiv e formulation s t o underg o emissio n characterizatio n independently , applyin g th e grou p representativ e principl e onl y i n regar d t o biologica l testin g requirements

. Thi s approac h woul dprovid e mor e definitiv e informatio n o n th e emissio n product s of eac h fuel an dadditive , bu t woul d increas e progra mcost s t o individua l manufacturer s an dwoul dincreas e demand s o n scarc e commercia l laborator y capacity

. EP

A request s inpu t fromth e publi c o n th e likel y benefit s an dcost s of

imposin g separat e emissio n speciatio n requirement s for eac h fue l an dadditiv e a s compare dt o requirin g th e emission s dat aonl y fo r th e designate dgrou p representative

. . C. Grouping System Implementation Issues Th e practica l implementatio n o f th e groupin g syste minvolve s tw o majo r tasks : th e organizatio n an d administratio n of

grou p functions , an d th e developmen t

o f equitabl e arrangement s for

cos t sharing

. Backe d b y it s experienc e wit h respec t t o th e TSC A testin g program , EP A believe s tha t th e fuel/additiv e industry , unde r th e aegi s o

f it s variou s trad e association s o r

othe r thir dparties , i s capabl e o f accomplishin g thes e task s wit h littl e o r

n o Agenc y assistanc e an d interference

. However , effectiv e operation s will b e critica l t o th e overal l succes s o f

th e groupin g provision s of th e registratio n program , an dsuggestion s fromth e industr y ar e invite da s t o practica l way s i n whic h EP A ma y b e abl e t o facilitat e th e implementatio n o f th e rule

. 1

. Organizationa l Task s Th e primar y organizationa l tas k i s th e formatio n o f

consortium s of

refiner s an d manufacturer s whos e product s ar e potentia l member s of

th e sam e EPA

define dfuel/additiv e groups
. Thi s tas k wil l entai l th e developmen t o f procedure s whic h wil l allo w manufacturer s wh o wis h t o participat e i n grou p function s t o locat e an dfor m workin g association s with othe r manufacturer s of

product s whic h fit

th e sam e groupin g criteria

. Whil e willin g t o provid e alimite damoun t of support , information , an dguidanc e whe n necessary , EP

A doe s no t

inten dt o determin e th e prope r

grou p fo r eac h fuel an dadditive , no r

t o infor mth e manufacture r

o f tha t grou p assignmen t Rather , manufacturer s wil l b e expecte d t o determin e th e appropriat e group s for thei r product s independently , accordin g t o groupin g criteri apublishe di n th e final rule , an dt o enrol l thei r

product s int o thos e group s unde r

industry-sponsore d brokerin g mechanisms

. EPA expect s manufacturer s t o commen t o n th e groupin g schem e i n thi s proposa l an d doe s no t inten dt o addres s specia l request s fo

r exception s t o th e groupin g schem e afte r

th e final rul e i s promulgated

. Onc e th e grou p member s hav e bee n identified , administrativ e agreement s wil l nee dt o b e reache dconcernin g th e divisio n of

responsibilitie s amon g th e respectiv e manufacturer s fo r meetin g th e specifi c requirement s of th e registratio n progra man dfor preparin g th e join t submitta l o f

tes t result s an d othe r informatio n t o EPA

. T o mee t th e program' s literatur e searc h requirement s an df o documen t

th e exten t

t o whic h existin g tes t

result s ar e adequat e t o mitigat e ne w testing requirements , arrangement s ma y b e neede dfo r sharin g in-hous e healt h effect s tes t dat aan d compilin g additiona l informatio n from publishe dsources
. Fo r

ne w testing , administrativ e arrangement s wil l nee d t o b e reache dwit h respec t t o th e selectio n and/o r

formulatio n o f

th e designate drepresentativ e product(s ) t o b e tested , th e acquisitio n of vehicle s require dfor

emissio n generation , th e identification o f

qualifie dpersonne l an d laboratorie s t o conduc t

th e tests , an d th e establishmen t

of qualit y assuranc e mechanism s whic h will ensur e tha t procedure s an dprotocol s ar e performe d accordin g f

o acceptabl e standards

. Som e groups , especiall y thos e i n th e baselin e conventiona l fuel/additiv e categories , will potentiall y b e ver y large , an dconsiderabl e coordinatio n effor t ma y b e required

. Th e tas k of organizin g th e fuel / additiv e group s wil l b e complicate db y th e fac t tha t th e respectiv e producer s wil l sometime s b e competitor s i n th e sam e specifi c marke t

segmen t an dtha t eve n th e identificatio n of aproduc t

a s a potentia l membe r

o f agive n grou p ma y revea l informatio n tha t

aproduce r woul dprefe r

t o kee p confidential

. Industr y trad e association s ma y b e abl e t o establis h "third-party " mechanism s whereb y individua l manufacturer s ca n enrol l thei r

product s i n appropriat e group s whil e minimizin g th e exten t t o whic h confidentia l dat amus t b e revealed

. Eac h produce r

wil l nee dt o determin e whethe r

th e cost-sharin g advantage s provide db y grou p participatio n outweig h th e possibl e competitiv e risks involved

. However , whethe r amanufacture r

choose s t o participat e i n grou p function s o r t o satisf y th e registratio n requirement s throug h independen t

testing , sectio n 211(b)(2 ) stipulate s tha t

"th e result s of suc h test s shal l no t

b e considere d confidential"

.

### P.2 7

1319 2 Federa l Registe r / Vol

. : 7 3 /

Wednesday , Apri l 15 , 199 2 / Propose dRule s

2

. Cost-Sharin g Provision s Th e mai n purpos e o f

th e propose d groupin g syste mi s t o appl y sectio n 211(e)(3)(B) , whic h permit s producer s wh o manufactur e o r

proces s th e sam e fue l o r fue l additiv e t o shar e th e responsibilitie s o f

th e progra ms o tha t requirement s ca n b e me t withou t duplicatio n o f

cos t an deffort

. EP A ha s ha dextensiv e experienc e wit h cost

share dtestin g conducte db y manufacturer s i n complianc e wit h regulation s unde r

TSC A Sectio n 4

. T o date

. EP A ha s foun dth e person s conductin g test s unde r Sectio n 4 hav e chose n i n eac h instanc e t o wor k ou t thei r ow n arrangement s fo r cost-sharin g o r reimbursemen t

withou t an y nee dfo r EP A involvement

. Whil e forma l dat a reimbursemen t

regulation s wer e issue d fo r thi s purpos e i n 4 0 CF Rpar t 791

. n o on e ha s ye t

invoke dth e procedure s therein

. EP A believe s tha t

asimila r

resul t woul db e likel y if

cost-sharin g rule s wer e promulgate dwithi n th e fuel s an d fue l additive s registratio n program
. A t thi s time , therefore

. EP A propose s t o leav e th e developmen t

o f specifi c cost

sharin g agreement s u p t o th e participatin g manufacturers

. However , comment s ar e solicite dconcernin g th e potentia l nee dfo r

EP A involvemen t

i n thes e arrangements

. I

f suc h involvemen t i s deeme dnecessary , opinion s ar e requeste do n th e adequac y o f existin g TSC A regulation s fo r

thi s purpos e o r

a n alternativ e cost-sharin g guideline s o r procedures

. On e possibilit y unde r

consideratio n woul drequir e manufacturer s o f existin g fuel s an dfue l additive s t o notif y EP A withi n on e yea r

afte r publicatio n o f

th e fina l rul e if

the y intende dt o compl y wit h th e rul e a s par t

o f agrou p and

. if so , t o identif

y th e perso n o r

entit y whic h wa s organizin g th e testing

. Fo r ne w fuel s an dfue l additives , manufacturer s woul d b e require dt o conduc t

th e testin g individuall y unles s the y first certifie dt o EP A tha t the y intende dt o rel y o n dat a previousl y submitte db y amanufacture r o f asimila r

product

. Th e certificatio n woul dnee dt o includ e assurance s tha t th e firs t manufacture r

ha dbee n notifie d o f thi s inten t

an dtha t th e first manufacture r

ha s th e righ t

t o reimbursemen t

unde r procedure s suc h a s thos e specifie da t

4 0 CF Rpar t

791

. Comment s o n thes e possibl e mechanism s ar e requested

. Arrangement s fo r

cost-sharin g wil l nee dt o accoun t

fo r tw o genera l situations

. I n on e case , group s o f producer s woul dorganiz e prospectivel y t o complet e th e sam e progra m requirement s fo r

thei r simila r products

. I n thi s instance , cost-sharin g arrangement s coul db e reache di n advanc e o f

testing

. Suc h arrangement s migh t divid e th e progra mcost s o n aper
produc t basi s o r i n proportio n t o applicabl e marke t

share , sale s revenue , productio n volume , and/o r othe r relevan t parameter s whic h participatin g manufacturer s agre e woul db e equitable

. Th e secon dsituatio n involve s th e cas e wher e adequat e informatio n alread y exist s fo r

th e registratio n o f

a produc t becaus e th e require dtest s hav e bee n complete db y anothe r manufacture r

(o r grou p o f manufacturers ) o n simila r product s (i.e. , product s meetin g th e criteri afo r membershi p i n th e sam e grou p a s th e ne w product)

. I n thi s instance , th e cost s o f progra mcomplianc e woul dalread y hav e bee n incurred , an damanufacture r wit h asimila r

produc t wishe s t o repl y o n thi s existin g testin g i n satisfactio n o f th e registratio n requirement s fo r hi s simila r product

. EP A propose s that , t o us e th e existin g tes t

results , th e ne w manufacture r

woul db e require dt o notif y th e existin g manufacture r tha t h e ha s use dth e dat asn dappris e hi mo f hi s righ t t o b e reimburse dEP A invite s comment s o n whethe r

thes e arrangement s shoul db e lef t t o th e producer s t o wor k

ou t amon g themselves

. Alternatively

. EP A rule s coul db e promulgate dspecifyin g th e computatio n o f

reimbursemen t

fee s an d th e numbe r

o f year s tha t

reimbursemen t right s woul dremai n i n effect

. I n tha t instance

. EP A propose s tha t th e "ownership " perio dfo r registratio n informatio n shoul dlas t fo r fiv e year s afte r dat asubmission

. T o b e reimburse d whe n ne w producer s see k t o rel y o n thei r existin g dat afo r

fuel/additiv e registration , th e origina l producer s (o r group s o f

producers ) woul db e require d t o documen t

th e cost s alread y incurre d i n conjunctio n wit h th e registratio n program' s informationgatherin g an d testin g requirements

. Tn e leve l o f reimbursemen t

woul db e determine d accordin g t o th e applicabl e cost s an d th e numbe r

o f producer s relyin g o n th e informatio n fo r

registratio n purposes
. Comment s ar e requeste dabou t th e suitabilit y o f

thes e o r othe r alternativ e reimbursemen t

arrangements

. V

. Emissio n Generatio n A s discusse di n sectio n III.E , th e propose drequirement s fo r evaluatin g th e potentia l emissions-base dhealt h an dwelfar e effect s o f

fuel s an dfue l additive s includ e analyti c procedure s i n Tie r 1 fo r characterizin g th e chemica l compositio n o f

fuel/additiv e emissio n products , a s wel l a s biologica l studie s i n Tier s 2 an d3 involvin g th e exposur e o f laborator y animal s t o fuel/additiv e emissions

. Thi s sectio n present s th e method s propose dfo r generating , storing , an dsamplin g th e emission s t o b e use di n thes e chemica l an dbiologica l tests

. Wit h afe w note dexceptions , emission s wil l b e generate daccordin g t o th e Federa l Tes t

Procedure s (FTP ) fo r light-dut y vehicle s (4 0 CFRpar t 88)

. A. Vehicle Requirements 1

. Vehicl e Selectio n Becaus e th e compositio n o f emission s produce db y agive n fue l o r additiv e i s likel y t o var y somewha t dependin g o n th e vehicl e involved , afull y comprehensiv e testin g progra mwoul d nee dt o encompas s th e emission s fro m man y vehicle s representin g acomplet e cros s sectio n o f

th e in-us e fleet

. I n th e contex t ofth e propose dReformulate d Gasolin e Rulemaking

. EP A suggeste d tha t t o obtai n astatisticall y significan t se t o f emissio n characterizatio n result s encompassin g th e variet y o f emissio n contro l system s available , emission s woul dnee dt o b e generate dfro ma t leas t 2 0 vehicle s fo r

eac h fue l unde r evaluatio n (se e Supplementa l Notic e o f Propose dRulemaking , availabl e i n Docke t #A 9 1 02)

. Fo r

purpose s o f

th e routin e registratio n o f

moto r vehicl e fuel s an dfue l additives , however

. EP A believe s tha t

suc h a n extensiv e emissio n samplin g an dtestin g schem e ma y no t b e reasonabl e o r

necessary
. EP A i s initiall y proposin g tha t

onl y on e vehicl e b e require dt o generat e th e emission s t o b e use dfo r th e chemica l an dbiologica l testin g include di n Tier s 1 an d2, whil e potentia l Tie r

3 requirement s migh t

cal l fo r th e us e o f

additiona l vehicles

. Alternative s t o thi s basi c proposa l ar e discusse dlate r

i n thi s section

. Simila r t o th e reformulate dgasolin e proposal , th e parameter s t o b e considere di n specifyin g th e vehicle s t o b e use dfo r

emissio n generatio n includ e vehicl e class , emissio n contro l equipment , an dvehicl e sale s volume

. First , fo r eac h fue l family , th e vehicl e clas s an dsubclas s t o b e use dfo r emissio n generatio n wil l b e tha t whic h reflect s th e highes t

yearl y amoun t

o f consumptio n o f

fuel s i n tha t

family

. Normally , vehicl e classe s includ e light

dut y vehicle s (LDV)

. light-dut y truck s (LDT)

. an dheavy-dut y vehicles/engines

. Fo r purpose s o f

thi s program , however

. EP A propose s tha t

LD V an dLD T b e combine dint o on e vehicl e class

. LD T represen t

alarg e fractio n o f

th e gasolin e fue l consume di n th e U.S.

. bu t les s tha n th e fractio n attributabl e t o LDV , Thus , if LD V an dLD T ar e maintaine di n separat e classes

. LD T woul dprobabl y no t b e selecte dfo r

generatin g emission s fro mgasolin e fuel s an dfue l additives

. Althoug h LD V an dLD T ar e expecte dt oP.2 8

Federa l Kegiste r/

Vol . 57 , No . 7 3 /

Wednesday , Apri l 15 , 1992. / Propose d Rule s produce simila remissions , reflectin g th e fac tthatthei rengines , emissio n control systems , an d emissio n standard s are similar , th e absenc e of

LO T i n th e progra m migh tstil l reduce th e representativenes s of

th e tes temission s fo rgasolin e fuel s an d fuel additives
. Commen to n whethe ro

rno tLD V and LD T shoul d b e combine d into on e vehicl e clas s woul d b e appreciated
. I n vie w of th e overwhelmin g proportion of

total diese l vehicl e mile s wliic h are travele d b y heavy-dut y diese l vehicles , heavy-duty engine s are expecte d t

o b e use d t

o generate tes t emission s fordiese l fuel s an d fuel additives
. Becaus e of

th e lack o

f heavy
dut y vehicl e testin g faciUties , however , emissio n generatio n usin g light-dut y vehicle s of

th e sam e fue

l clas s ma

y b e preferabl e fro

m th e standpoin to f practicality
. Comment

s ar e requeste d o n thi s issue
. Th e nex tste p i s f

o determin e th e selectio n criteri a fo

rspecifi c vehicl e models . Th e vehicle s t o b e use d fo r emissio n characterizatio n mustb e ne w vehicle s of

th e mode l yea ri n whic h testin g begins
. However , vehicl e selectio n criteri a are t

o b e base d o n technolog y characteristic s of th e previou s model year . Th e grou p o r company seekin g registratio n woul d first detennin e th e mos tcommon fue l syste m an d emissio n control syste m combinatio n i n th e applicabl e vehicl e class . Th e criteri a t o b e considere d fo r light-dut y gasolin e powere d vehicles , for example , migh

tb e fue l metering approach (carburetted , fue l injecte d (port, throttl e body ) an d emissio n control approac

h (catalys ttype , ai r injection , exhaus tga s recirculatio n (EGR)
. feedbac k control , etc.)
. Th e company coul d the n selec tfortestin g an y on e o f th e fo p five sellin g model s with thes e characteristics , base d o n th e previou s mode l year' s sales . I f an y of th e five selecte d model s wer e no t availabl e i n th e mode l yea rwhe n th e ne w vehicl e wa s t o b e purchase d for testing , th e selectio n woul d b e limite d t o th e model s remaining
. I n general , th e vehicl e selectio n criteri a describe d abov e woul d b e use d t o determin e th e representativ e vehicle s fo ral l fue l families
. However , fewe r than five vehicl e model s may b e availabl e for"alternative " fuel families
. I n such.instances , an y availabl e model coul d b e use d fo rtesting
. Th e propose d vehicl e selectio n procedure i s mor e thoroughly describe d an d illustrate d i n a memorandu

m entitled , "Vehicl e Selectio n Procedure s forth e Propose d Fuel s and Fue

l Additive s Rulemaking, " availabl e i n th e publi c docket . Commen ti s requeste d o n ho w t o determin e th e type s o

f vehicle s tha

t shoul d b e use d f

o tes tfuel s and additive s which are notcommonly use d o rintende d t

o b e use d i n th e vehicl e typ e which th e standard vehicl e selectio n procedur

e woul d prescribe
. Thi s situatio n migh

tarise , forexample , i n th e selectio n of

vehicle s fortestin g lea d substitute aftermarke tadditive s (which ma

y damag e vehicl e catalysts ) and fo rtestin g number1 diese l fuel (mos tcommonly use d i n urba n buses)
. 2
. Mileag e Accumulatio n Requirement s Mileag e accumulatio n i s importan tfo r thi s progra

m fo rtw o primar

y reasons : I

t "break s in " a ne w vehicl e s o tha tth e emission s stabiliz e (an effectwhic h i s independen tof

th e fue l use d i n th e vehicle ) an d i

f allow s potentia l long
ter m effects of

th e fuel oradditiv e o n emission s f

o b e assessed . Suggestion s fo rth e amoun

to f mileag e accumulatio n appropriat

e forthi s progra

m hav e varied
. Som e hav e suggeste d tha f th e minimu m mileag e neede d t

o "brea k in " a ne w vehicl e (approximatel y 4,00 0 mile s forlight-dut

y vehicles ) woul d b e sufficientforthi s program, claimin g that th e fuel s use d i n th e vehicl e d o no t drasticall y affectth e emission s of a vehicle
. Others hav e suggeste d that emissio n characterizatio n b e continue d throughou

tth e useful lif

e mileag e of

th e vehicl e (50,000 mile s fo

rlight-dut

y vehicles , changin g t o 100,000 mile s i n 1994) i n ordert

o determin e th e full effects o f th e fue l o radditiv e bein g tested . Anothe r advantag e gaine d b y requiring a significan tamountof mileag e accumulatio n i s tha ti treduce s th e chanc e o f

"gaming " th e tes tresult s b y discouragin g th e testin g o f a number o f vehicle s an d selectio n of th e bes t results . Therefore , EP

A propose s 25,000 mile s a s th e minimu

m mileag e whic h mus tb e accumulate d usin g th e subjec t fue l oradditive/bas e fuel mixtur e before testin g i s conducted . Thi s valu e reflects a pointbetwee n th e tw o position s that provide s a reasonabl e opportunit y for long-ter m effect s of

th e fuel o r additiv e t o b e revealed , whil e a

tth e sam e time avoid s undue burden ; A s wil l b e discusse d furthe

rbelo w i n section s V.D an d VI.A.2.f

, additional mileag e ma

y b e necessar y forfuel s an d additive s containin g atypical elements . Commen t with supporting data i s requeste d regarding th e appropriat

e mileag e accumulatio n requirement s forvehicle s use d i n th e testin g o

f baseline/non
baselin e an d atypical formulations
. Th e propose d mileag e accumulatio n woul d b e required t

d begi n whe n th e vehicl e wa s new , usin g onl y th e fue l or additive/bas e fue

l mixtur e o f interest
. Mileag e coul d b e accumulate d b y an y appropriat

e means . Forexample , th e vehicl e coul d b e place d i n th e company' s fleet , hel d fo r controlle d flee t use , ordrive n o n th e street , tes ttrack, or dynamomete rsolel y fo

rth e purpos e of mileag e accumulation
. Vehicle s woul d b e required f

o b e unmodified and maintaine d a s instructe d i n th e vehicl e owner' s manual . 3
. Alternativ e Approache s A s state d earlier , a comprehensiv e determinatio n of

th e emission s from a fue l o radditiv e coul d requir

e testin g th e emission s from a

f leas t2 0 vehicles , an d EP A reques tcommen

to n whethe r testin g emission s generate d b y onl y on e vehicl e i s sufficien tf

o scree n fo r representativ e emissio n compound s and thei rrelate d biologica l effects i n thi s program . EP

A i s considerin g a compromis e betwee n testin g on e vehicl e an d testin g 2 0 vehicles , i n whic h perhap s thre e t o si x vehicles , representin g differing emissio n control technologies , woul d b e use d t o generate emission s foremissio n characterizatio n purposes . On e of

thes e vehicles , or perhap s a combinatio n thereof , woul d b e chose n f

o generat e emission s for biologica l testing
. Anothe rpossibl e variatio n i n th e proposal woul d allo w in-us e vehicle s whic h hav e alread y accumulate d sufficien tmileag e t o b e employe d for generatin g emission s instea d of requiring mileag e accumulatio n o n ne w vehicles
. Whil e thi s alternativ e woul d reduc e complianc e costs, i tha s som e possibl e drawbacks . Long-ter m emissio n effects cause d b y th e fuel s an d additive s previousl y use d i n thes e vehicle s coul d alte rth e generate d emission s and therefore th e emissio n characterizatio n an d biologica l tes tresults . I twoul d the n b e difficultt

o asses s th e exten tf

d whic h th e tes tfue l wa s responsibl e fo rth e tes t results . Anothe r drawback i s th e absenc e of

informatio n o n th e long-ter m effects of th e tes f fuel oradditive
. Finally , gaming coul d occu rsuch that , emmissio n characterizatio n coul d b e performe d o n many vehicle s an d only . th e bes tresult s submitted
. Commen ti s requeste d on'whethe r in-us e vehicle s woul d b e acceptabl e fo

rthi s program . : EP A ha s als o identifie d a n alternativ e emissio n generatio n scenari o whic h incorporate s a number of th e possibl e progra m modification s describe d above . Becaus e thi s scenari o woul d requir e th e us e o f more vehicle s i n th e testin g progra m i n ordert o increas e th e confidenc e thatca n b e place d i n th e results , method s of

reducing othe r associate d cost s hav e als o bee n identified
. First , with regar

d t o fuel s an d additive s thatd o no tcontai n a n atypical elemen t(i.e. , thos e i n th e baselin e andP.2 9

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non-baselin e formulatio n classes) , th e require dnumbe r

o f vehicle s woul db e increase dfromon e t o six

. Th e vehicl e selectio n criteri awoul dinclud e th e sam e emissio n contro l syste m characteristic s a s describe dpreviously , excep t tha t si x technolog y group s woul d b e determine dfromth e emissio n contro l syste mcombinations , an dth e to p selle r fromeac h grou p woul db e include di n th e program
. T o reduc e costs , mileag e accumulatio n requirement s pe r vehicl e woul db e reduced , perhap s t o th e 4,000

- 10.000 mil e range
. Th e us e o f ne w vehicle s woul db e encouraged , bu t in

us e vehicle s woul db e permitte dafte r specifie dintermediat e preconditioning , assumin g tha t

th e fuel or

additiv e produce r wa s willin g t o accep t

th e progra moutcom e ris k

of usin g vehicle s whic h ha dbee n operate do n othe r fuel s an dadditives

. A prim e tene t

o f thi s approac h i s tha t emission s carryove r

fromth e us e of

on e fue l o r additiv e t o anothe r

i n th e sam e vehicl e ca n b e eliminate db y a n intermediat e preconditionin g process
. Thi s woul dpenni t

on e vehicl e t o b e use dt o generat e emission s for mor e tha n on e product

. On e potentiall y applicabl e intermediat e preconditionin g metho dha s bee n use di n th e Join t Auto / Oi l Ai r Qualit y Improvemen t

Program

. Additiona l discussio n o n preconditionin g method s i s availabl e i n amemorandu mi n th e publi c docket

. EP A ask s for

commen t o n th e validit y o

f th e assumptio n tha t

fue l emissio n carryove r effect s ca n b e eliminate dwit h areasonabl e amoun t

of intermediat e preconditioning

. A vali dpreconditionin g proces s woul dno t

onl y penni t

previousl y use d vehicle s t o b e employe di n th e testin g program , bu t

woul dals o allo w th e sam e vehicle s t o b e use dfo r

testin g mor e tha n on e product

. Fo r

example , th e propose d testin g of fuel additive s require s th e emission s of

a n additive/bas e fuel V mixtur e t o b e compare dwiti i th e emission s o f

th e bas e fuel alone

. Thi s coul db e accomplishe db y performin g on e se t of emissio n characterizatio n contro l test s o n th e bas e fuel i n eac h o f th e si x vehicles

. Then , wit h intermediat e preconditioning , th e sam e se t o f si x tes t vehicle s coul db e use dt o perform emissio n characterizatio n for an y numbe r o f fue l additive s i n th e sam e fuel family , excludin g thos e wit h "atypical " elements

. I n thi s way , onl y on e se t o f bas e fue l emissio n characterizatio n result s woul dsuffic e fo r

al l product s tha t underwen t

testin g usin g th e sam e se t of vehicles

. Specifi c fuel formulation s subjec t t o testin g woul dals o b e require dt o underg o emissio n characterizatio n usin g si x vehicles

. Commen t i s requeste da s t o whethe r producer s testin g thes e specifi c formulation s should , for

compariso n purposes , als o b e require dt o tes t th e applicabl e bas e fuel usin g th e sam e si x tes t vehicle s (assumin g tha t

th e fue l bein g teste di s no t

itsel f abas e fuel)

. Unde r thi s scenari o th e incrementa l expens e woul db e expecte dt o b e small

. A s wa s mentione dabove , aspecifie d intermediat e preconditionin g cycl e woul dhav e t o b e performe da t th e tim e th e vehicl e i s switche dbetwee n differen t fuels , additive/bas e fuel mixtures , o r

th e bas e fuel

. Onc e th e emissio n characterizatio n wa s complete , on e o f

th e sam e si x tes t vehicle s woul db e selecte dan duse dt o generat e emission s for.biologica l testing

. Th e selectio n of

thi s vehicl e woul db e base do n analysi s of

th e emissio n characterizatio n data

. A numbe r o f alternativ e selectio n criteri aar e possible

. Fo r

example , th e vehicl e coul d b e chose n t o represen t

eithe r th e averag e o r

highes t emissio n rat e o f volatil e organi c compounds , tota l toxicants , particulat e matter , and/o r PAH

. EP A woul dappreciat e commen t o n th e parameter s tha t

shoul db e use dt o selec t th e vehicl e t o b e use dfo r emissio n generatio n fo r

biologica l testing

. Anothe r

possibilit y woul db e t o us e al l si x vehicles , with eac h vehicl e generatin g emission s for

one-sixt h o f

th e testin g tim e period

. Fo r fuel s an dadditive s i n th e atypica l formulatio n class , th e atypica l element s potentiall y hav e amuc h greate r chanc e of affectin g th e vehicles ' emissio n contro l components , makin g long-term emissio n effect s muc h mor e likely

. Thu s longe r mileag e accumulatio n t o stead y stat e ma y b e necessary
. Furthermore , multipl e us e o f

vehicle s ma y no t

b e possibl e becaus e th e intermediat e preconditionin g proces s ma y no t b e effectiv e a t

eliminatin g potentia l carryove r effect s of th e atypica l elements

. T o increas e confidenc e i n th e
. result s of th e testing , si x vehicle s selecte da s describe dabov e woul db e require dt o accumulat e mileage

. I n orde r t o isolat e long-termeffects , EP A ' propose s t o requir e th e us e o f ne w vehicles , bu t

ask s fo r commen t o n whethe r lo w mileag e use dvehicle s woul db e a n acceptabl e alternative

. Emission s fromal l o f

th e tes t vehicle s woul db e characterized , an dthes e * result s woul db e compare dwit h di e baselin e grou p representativ e o f tha t fuel clas s (se e sectio n V.E.2)

. Finally , tw o alternative s hav e bee n identifie dfo

r conductin g biologica l testin g o n grou p representative s i n th e atypica l formulatio n class

. Unde r th e first alternative , onl y on e o f

th e vehicle s woul db e chose n t o underg o furthe r mileag e accumulatio n t o reac h stead y stat e (e.g. , th e vehicl e with th e highes t atypica l elemen t

emissio n rat e o

f th e si x vehicles)

. Then , speciatio n of th e emission s containin g atypica l element s an dth e require dbiologica l test s woul d b e performed

. Unde r

th e secon d alternative , al l of

th e vehicle s woul d nee dt o reac h stead y state

. Speciatio n o f th e atypica l emission s woul dthe n b e don e for al l si x vehicles

. Biological testin g coul db e don e eithe r o n on e selecte dvehicle , o r

eac h vehicl e shar e i n th e emissio n generatio n fo r biologica l testin g (a s wa s discusse dabov e fo r th e baselin e an dnon-baselin e formulatio n classes)

. EP

A solicit s comment s o n thes e scenario s designe dt o cost

effectivel y generat e th e dat arequire db y th e statute

. B. Combustion Emission Generation Th e FT P throug h th e exhaus t emission s tes t

i s th e metho dpropose d fo r generatin g th e combustio n emission s neede dt o mee t

th e emissio n characterizatio n requirement s o f Tie r 1

. Thes e procedure s ar e specifie di n 4 0 CF Rpar t 8 6 fo r th e certificatio n o

f ne w moto r vehicles , an dma y var y dependin g o n th e fuel famil y an dvehicl e class

. Consisten t

wit h .th e curren t

FTP requirements , caniste r

loadin g durin g th e FT P preconditionin g phas e mus t b e don e b y method s tha t

us e actua l evaporativ e emission s rathe r tha n benc h methods , whic h us e asurrogat e compoun dfor

caniste r loading

. Thi s wil l hel p t o ensur e tha t

emission s ar e generate dexclusivel y fromth e fuel o r additiv e bein g tested

. Modification s t o th e standar dFT P wil l b e neede dt o collec t particulat e an dsemi-violatil e emissions , whic h ar e require dboth for emissio n characterizatio n an di n vitr o biologica l testing

. Th e particulat e fractio n i s t o b e collecte do n filter s an d th e semi-volatil e emission s collecte d immediatel y downstrea mfro mthes e filters, usin g porou s polyme r bed s o r othe r equipmen t

designe dfo

r thei r capture

. Afte r collection , th e organi c fractio n of th e particulat e an dsemi-volatil e emission s woul db e extracte d separatel y fro meac h othe r usin g appropriat e laborator y procedures

. Becaus e th e extracte dmaterial s woul d b e muc h mor e stabl e tha n gaseou s combustio n emissions , the y coul db e store dfor longe r period s of

tim e before use
. Fo r thi s reason , th e particulat e an d semi-volatil e emission s coul db e generate dan duse di n differen t locations , a s lon g a s prope r handlin g technique s wer e observed

. Fo r i n vitr o biologica l testin g purposes , th e particulat e emission s ma yP.3 0

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b e collecte do n asingl e filter instea do f o n multipl e filters a s prescribe di n th e FTP

. Similarly , semi-volatil e phas e emission s ma y b e collecte do n on e apparatu s for

th e entir e drivin g cycle

. I f a n insufficien t

amoun t of particulat e o r semi-volatil e materia l i s obtaine ddurin g asingl e drivin g cycle , th e FT P ma y b e repeate da s require dan dth e extracte d organi c fraction s combined

. Man y o f th e i n viv o biologica l test s propose di n today' s notic e woul d requir e si x week s exposure s o f laborator y animal s t o whol e combustio n emission s for

aminimu mo

f si x t o eigh t hour s pe r day

. Th e continuou s generatio n o f

emission s throughou t

th e require dexposur e period s require s light

dut y vehicle s t o b e drive n throug h repeate dUrba n Dynamomete r Drivin g Schedul e (UDDS ) drivin g cycle s an d heavy-dut y engine s t o b e operate dove r repeate dEngin e Dynamomete r Schedul e (EDS ) cycle s (40 CF

Rpar t 86 , appendi x I) , wit h emission s dilute dan droute d directl y fromth e vehicl e t o th e biologica l testin g chamber

. Provision s i n th e propose dregulation s allo w for a limite damoun t

of emissio n generatio n disruptio n withou t

voidin g th e biologica l test

. Th e us e of

automate dsystem s ma y provid e amean s t o reduc e th e difficultie s associate dwit h continuou s emissio n generation

. Automate d system s woul dinvolv e computerize d mechanism s use dt o driv e th e vehicl e o n achassi s dynamomete r

o r a n engin e o n a n engin e dynamometer

. Thes e system s coul db e use di n plac e o

f huma n operator s t o performth e monotonou s tas k o f performin g repeate ddrivin g cycles

. Throttl e actuator s linke dt o a compute r syste malon g wit h electri c chassi s dynamometer s coul db e programme dt o driv e vehicle s ove r drivin g cycles

. Suc h system s hav e bee n use di n th e pas t

fo r mileag e accumulatio n purpose s an dfo r assembl y lin e vehicl e testing

. However , thei r appUcatio n i s limite dt o vehicle s equippe dwit h automati c transmissions

. Roboti c driver s ar e fairl y recen t option s for

automate dvehicl e operation , an dar e expecte dt o provid e hig h repeatabilit y an dversatility

. Th e technolog y fo

r thes e system s ha s bee n develope dfor

relate dapplications , bu t ha s no t bee n widel y use dthus far

. A thir dpossibilit y for

automatio n woul dinvolv e th e us e o

f a n isolate d engin e (i n conjunction , perhaps , wit h th e vehicle' s fue

l an demissio n contro l systems ) attache dt o a n engin e dynamometer

. Sinc e th e inpu t parameter s require dfo

r controllin g engin e dynamometer s ar e differen t fro m th e whee l spee ddrivin g trac e o f th e chassi s dynamometer , th e light-dut y Urba n Dynamomete r Drivin g Cycl e woul dnee dt o b e translate dt o a n equivalen t

load-spee dpattern , o r

els e a n alternat e drivin g cycl e woul db e required

. EP A i s initiall y proposin g t o requir e th e us e of engin e dynamometer s t o generat e emission s fo

r th e heavy-dut y clas s an dchassi s dynamometer s t o generat e emission s fromlight-dut y vehicles

. I n th e heavy-dut y case , us e of a n engin e dynamomete r

for emissio n generatio n i s consisten t

wit h al l existin g heav y dut y emissio n testin g program s an dals o provide s considerabl e cos t advantages

. I n contrast , i n th e light-dut y case , existin g emissio n testin g program s requir e th e us e of

avehicl e operate do n achassi s dynamomete r

for emissio n generation

. T o us e a n engin e dynamomete r

for thi s purpose , extensiv e testin g woul dhav e t o b e don e t o demonstrat e tha t

th e exhaus t

emission s wer e th e sam e a s thos e generate dfrom th e correspondin g light-duty vehicl e operate do n achassi s dynamometer

. Man y technica l problem s woul dhav e t o b e confronte di n attemptin g t o isolat e th e engin e an demissio n contro l equipmen t

fromth e vehicl e whil e assurin g thaf

th e representativenes s of th e emission s woul db e maintained

. Thes e woul dinclud e decisions , o n whic h vehicl e system s mus t

remai n attache dt o th e engin e an dwha t

method s t o us e t o terminat e unnecessar y systems ; th e additio n of

aflywheel , harmoni c balancer , an dbel l housin g t o balanc e th e syste mfo r

vehicle s equippe dwit h automati c transmissions ; determinatio n of th e effec t of detachin g transmissio n sensor s suc h a s gea r

sensors , clutc h lock/unloc k

sensors , an dtorqu e coverte r spee dsensors ; an dth e translatio n o

f th e LA- 4 chassi s dynamomete r

drivin g cycl e t o a n operatin g cycl e appropriat e for us e wit h a n engin e dynamometer

. EPA believe s tha t

th e putativ e cos t saving s associate dwit h th e us e o f a light-duty engin e dynamomete r rathe r tha n alight-duty vehicl e an dchassi s dynamomete r

woul db e overridde n b y th e cost s associate dwit h resolvin g thes e problem s an dperformin g test s t p prov e tha t th e solution s wer e yatid

. However , EP A i s ope n t o commen t

o n th e relativ e cost s an dbenefit s of

th e light-duty chassi s dynamomete r

vs
. engin e dynamometer , an dwoul dconside r makin g th e us e of

th e engin e dynamomete r

optiona l i n thi s progra mi f th e comment s provid e persuasiv e evidenc e tha t

thi s optio n woul db e advantageous

. C. Evaporative Emission Generation A s discusse dabov e th e sectio n III.C , th e evaporative , emission s o f som e fuel s an dadditive s wil l b e require dt o

underg o emissio n characterizatio n an d biologica l testing

. Th e compositio n of evaporativ e emission s doe s not , i n general , resembl e fully-evaporate d whol e sample s o

f ra w fuel s o r

fuel additive s du e t o difference s i n vapo r pressur e of

th e fuel o r

additiv e component s an dth e effect s of evaporativ e emissio n contro l equipment

. Th e larges t

source s of

evaporativ e emission s fromvehicle s ar e diurnal , ho t soak , an drunnin g los s emissions

. Fo r th e purpos e of

thi s rulemaking , refuelin g emission s ar e also-regarde da s evaporativ e emission s du e t o thei r generall y simila r

composition

. Whil e th e mos t technicall y accurat e metho dof testin g thes e emission s woul db e t o characteriz e an dperformbiologica l test s o n eac h evaporativ e sourc e separately , suc h apla n woul dmultipl y th e cosf s involved

. Th e propose d evaporativ e emissio n characterizatio n require s cal l for

th e speciatio n of emission s froma

U type s o f

evaporativ e emission s measure di n th e FT P effectiv e a t th e time th e testin g i s done

. EP A ask s fo r comment s o n whic h type s o f evaporativ e emission s shoul db e speciate dan dif

th e progra mshoul db e expande df

o includ e runnin g losse s an d refuelin g emissions

. EPA i s als o proposin g tha t evaporativ e emission s b e generate d withou t usin g ke y component s of evaporativ e emissio n contro l systems , suc h a s th e carbo n adsorptio n canister

. A n intac t contro l syste mwoul d represen t norma l syste mdesign , an d remova l of

th e caniste r

woul dchang e th e relativ e concentration s of th e evaporativ e emissio n products

. O n th e othe r hand , disconnectin g th e evaporativ e emissio n contro l syste m woul dprovid e th e opportunit y t o examin e emission s simulatin g uncontrolle demissio n source s suc h a s refuelin g operation s an dleak y evaporativ e emissio n contro l systems

. Furthermore , a s discusse dbelow , us e of emissio n contro l ma y no t b e practica l for evaporativ e emissio n generatio n fo r biologica l testin g purposes
. I f th e emissio n characterizatio n procedure s ar e t o b e performe do n emission s tha t closel y resembl e thos e use dfor biologica l testing , i t

ma y thu s b e necessar y t o disconnec t

th e emissio n contro l syste mwhe n generatin g emission s fo r

speciatio n purposes , a s well

. Thre e simplifie dprocedure s ar e bein g considere dfor

continuousl y generatin g evaporativ e emission s for i n viv o biologica l testing

. Th e first woul d requir e that ' evaporativ e emissio n generatio n b e performe db y usin g aP.3 1

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seale dhousin g fo r

evaporativ e determinatio n (SHED3

. Tii e diurna l hea t buil dsectio n o f

th e FT P woul db e performed , an dsample s o f tiie vapor s i n th e SHE D woul db e withdraw n int o Tedla r bag s an duse dfo r

testing

. Chemica l artifact s cause db y storag e o f evaporativ e emission s ar e expecte dt o b e muc h les s of

aproble mtha n for combustio n emissions

. Fo r thi s purpose , th e SHE D woul dnee dt o b e equippe d wit h asamplin g por t

an dsamplin g pump
. T o avoi dmodificatio n o f th e sample , apump wit h lo w hydrocarbo n absorptio n an demissio n characteristic s (e.g. , ateflo n diaphrag mpump ) woul d b e required

. Generatin g evaporativ e emission s withou t

an y o f tiie ke y emissio n contro l syste mcomponent s i n plac e woul dhel p increas e th e concentratio n o f

evaporativ e emission s i n th e SHE

D i n orde r

t o produc e a sampl e usefu l for

biologica l testing

. However , th e concentratio n o f evaporativ e emission s i n th e SHE D might stil l b e to o lo w t o b e usefu l for biologica l testin g purposes , eve n i f di e evaporativ e emissio n caniste r wer e disconnected

. Anothe r alternativ e woul dus e evaporativ e emissio n speciatio n dat at o mak e asurrogat e mixtur e o f adequat e concentratio n fo

r biologica l testing

. Whil e thi s metho dmigh t

see mt o hav e som e practica l advantages , i t woul drel y heavil y o n th e speciatio n dat aa s a complet e an daccurat e representatio n o f in-us e evaporativ e emissions

. Th e thir dmetho dfor

generatin g evaporativ e emission s woul db e a n
. evaporativ e emissio n generatio n chambe r instea do f

avehicle

. Th e chambe r woul db e temperatur e an d pressur e controlle ds o tiiat it e characteristic s wer e simila r t o th e hea d spac e o f tiie fuel tan k

o f avehicl e wher e in-us e diurna l an drefuelin g emission s ar e generated

. Th e chambe r woul db e 4 0 percen t fille dwit h tiie fuel o r

additive / bas e fue l mixture , an dth e remainde r fille dwit h air

. Th e syste mwoul db e heate dt o aprescribe dleve l an dth e fuel o r additiv e mixtur e allowe dt o evaporate

. Whe n equilibriu mwa s reache dbetwee n tiie fuel i n tiie liqui d an dvapo r states , th e vapo r

an dai r mixtur e woul db e withdraw n fo r dilutio n an dtesting

. Th e fue l o r additive/bas e fuel mixtur e woul dnee d t o b e renewe dperiodicall y t o kee p tiie emission s o f

constan t character

. A n extensio n o

f tins concep t

woul d involv e th e constructio n o f abenc h apparatu s usin g aduplicat e o f th e fuel tan k o f di e vehicl e involve dtogethe r with heatin g elements

. Vapor s coul d the n b e draw n directi y fro mth e hea d spac e o f th e fuel tank

. However , thi s metho dmight creat e safety concern s concernin g th e heatin g o

f th e sampl e t o caus e evaporation

. On e optio n woul db e t o reduc e th e ai r

pressur e ove r

th e fuel o r additive/bas e fue

l mixtur e t o induc e evaporation

. I n compariso n wit h th e SHED-base d system , th e benc h metho dha s tiie advantag e o f

requirin g muc h smaller , les s expensive , an dsimple r equipmen t Emission s coul db e generate dclos e t o th e biologica l testin g chambers , an d largel y automate dsystem s coul db e used

. Anothe r

advantag e i s tha t

th e concentratio n o

f emission s whic h occur s i n th e biologica l tes t

chambe r coul db e controlle dt o amuc h greate r exten t with benc h method s tha n wit h th e SHED method , i n whic h ai r

dilutio n i s fixe db y th e siz e of

th e SHE D an dth e specifi c vehicl e generatin g th e emissions

. Th e surrogat e emissio n generatio n metho d ha s th e drawbac k

o f relyin g to o heavil y o n th e speciatio n dat afor it s accuracy
. Fo r thes e reason s EP

A propose s t o requir e th e us e o f

abenc h metho d(i.e.

. evaporatio n chambers ) fo r generatin g emission s fo

r i n viv o biologica l testing

. Comment s ar e requeste do n thi s issue

. EP A propose s tha t

evaporativ e emissio n contro l equipment no t b e use d o n th e emission s generate db y th e evaporatio n chamber

. A s state dabove , thi s woul denabl e th e testin g o f emission s whic h represen t uncontrolle d emissio n source s suc h a s refuelin g operations

. I n addition , remova l o f th e emissio n contro l caniste r woul dallo w th e generatio n o f

mor e concentrate d emissions , whic h ar e require dfor th e biologica l test s specifie dunde r Tie r 2 of thi s program
. A thir dreaso n i s th e , complexity o f

th e procedure s whic h woul db e require dfo r

caniste r loadin g an dpurgin g cycle s i

f th e emission s from th e evaporatio n chambe r wer e t o resembl e in-us e vehicl e evaporativ e emissions

. EP

A request s commen t

o n thi s questio n o f

th e prope r

us e o f evaporativ e emissio n contro l system s fo r biologica l testin g purposes
. EP A i s awar e tha t

th e method s propose dar e differen t

for combustio n an devaporativ e emission s wit h respec t t o th e role o f

emissio n contro l equipmen t

Thi s inconsistenc y arise s fro mpractica l considerations

. First ; i n th e cas e o f

combustio n emissio n contro L man y differen t

vehicl e component s ar e involved

. Whil e som e o f

thes e component s coul dpossibl y b e remove d o r disable dto simulat e emissio n contro l malfunction , other s ar e integra l to proper runnin g o

f th e engin e an dthei r remova l woul dcaus e th e vehicl e t o b e inoperable

. Therefore , generatin g totall y uncontrolle dcombustio n emission s woul dno t b e areasonabl e option

. Secondly , th e type s o f combustio n emissio n contro l equipmen t an deac h component' s individua l effect s o n emission s varie s greatl y fro mvehicl e t o vehicle , makin g i t

extremel y difficul t

t o devise , areasonabl e basi s fo r determinin g whic h component s coul d• selectivel y b e disabled

. Thus , al l combustio n emission s contro l component s ar e propose dt o b e maintaine dmth e prope r

functionin g conditio n durin g combustio n emissio n generatio n fo r

thi s program
. Conversely , a t

th e presen t

time , tiie primar y (vehicle-based ) sourc e o f evaporativ e emissio n contro l i s th e evaporativ e emissio n canister

. Thi s devic e doe s no t

affec t avehicle' s bperability

. I n orde r

t o obtai n evaporativ e emissio n sample s o f sufficien t concentratio n fo r

biologica l tests , an dt o represen t

uncontrolle d emission s sources , EPA ha s propose d tha t evaporativ e emissio n contro l equipment

b e disconnecte dfo

r evaporativ e emissio n generation

. Comment s ar e requeste do n whethe r a consisten t

us e o f emissio n contro l equipmen t

for combustio n an d evaporativ e emission s i s importan t for thi s program , an dif

so
. Ho w th e progra m shoul db e restructure dt o accomplis h thi s end

. I f th e progra mwer e restructured , EP

A specificall y ask s for commen t o n th e desirabilit y o f

usin g a controlle devaporativ e syste mfo r emissio n characterizatio n purpose s an d

. a n uncontrolle dsyste mfo r biologica l testing

. D. Additional

Emission Generation Topics 1

. Emission s fo r

Atypica l Element s Th e "atypical " element s describe di n sectio n I V (generally , thos e othe r tha n carbon , hydrogen , oxygen , nitrogen , an d alimite damoun t

o f sulfur ) ma y for

m particulat e combustio n product s whic h ca n deposi t

o n th e Insid e o f

the-vehicle' s engin e o r emissio n contro l system

. Depositio n o f

th e atypica l element s insid e th e vehicl e ma y b e particularl y significan t

whe n th e fiiel o r

fue l additiv e i s firs t introduced , thu s interferin g with identification an daccurat e measuremen t

o f th e atypica l species

. A s th e interna l deposit s increase , i t i s expecte dtha t

agreate r fraction wil l b e emitte dint o th e atmospher e unti l th e ne t depositio n insid e th e vehicle/engin e i s small

. A s i s discusse dfurthe r

i n sectio n VI.A.2. f below , additiona l requirement s ar e thu s propose dfo r

"atypical " fuel s an dadditive s t o ensur e tha t th e atypica l element s ar e fully represente di n th e sample demissions

. Afte r di e minimu mP.32

_

Federa l Registe r

/ Vol

. 57

. No

. 7 3 /

Wednesday

. Apri l 15

. 199 2 / Propose dRule s 1319 7
25.000 mile s hav e bee n accumulated , emission s wi

U b e coUecte dfromth e vehicl e an dsubjecte dt o preliminar y analysis , includin g th e standar d characterizatio n require dfo r al l fue l an d additiv e formulation s an dthos e whic h measur e th e presenc e of

atypica l element s i n exhaus t

and , if applicable , evaporativ e emissions

. Then , measurement s will b e mad e t o
. determin e whethe r

astead y stat e ha s bee n reache dbetwee n th e rat e of entr y an demissio n o f

th e atypica l elements

. I

f not , additiona l mileag e accumulatio n wil l b e performe dunti l th e emission s of th e atypica l element s reac h stead y state

. Stead y stat e will b e define da s th e poin t a t whic h th e mas s o f

th e atypica l element s emitte ddurin g th e performanc e of

on e o r mor e Urba n Dynamomete r

Drivin g Schedules/Engin e Dynamomete r

Schedule s i s withi n 1 0 percen t of th e mas s of

th e atypica l element s tha t

entere dth e combustio n chambe r durin g th e drivin g cycles

. I n determinin g whethe r

stead y stat e ha s bee n reached, som e les s obviou s pathway s for

th e los s o r

introductio n of th e atypica l element s ma y nee dt o b e take n int o account

. Fo r

example , i

f th e atypica l compound s coul db e los t throug h evaporation , the n th e evaporativ e emission s woul db e speciate dfo r

thes e compounds

. I

f th e atypica l element

enter s th e moto r

oi l vi a th e combustio n chamber , th e concentratio n of

th e atypica l element

i n th e moto r oi l ma y b e measure dan d entere dint o th e mas s balance

. I f ther e i s reaso n t o suspec t

tha t th e ai r use d durin g combustio n o r

dilutio n ma y contai n significan t

quantitie s of

th e atypica l element

unde r evaluation , thi s ai r mus t als o b e teste dan dth e proble m rectified

. EP A i s initiaUy proposin g tha t mileag e accumulatio n b e continue deithe r unti l stead y stat e of

th e atypica l element s ha s bee n reache do r

unti l th e vehicl e o r engin e ha s bee n operate do n (h e atypica l fuel o r

additiv e for

th e equivalen t

of 8 0 percen t

o f it s estimate d usefu l lif e (e.g. , 60,000 mile s for

light

dut y vehicles)

. Th e purpos e of thi s rigorou s requiremen t

i s t o ensur e tha t th e emissio n product s o

f th e element s of concer n ar e know n an dtha t thei r concentration s ar e stabl e whe n th e emission s ar e use di n subsequen t testing

. I n actua l use , however , fe w vehicle s ar e likel y t o b e drive n continuousl y o n "atypical " fuel s an d additives

. Th e us e o

f suc h product s b y consumer s i s mor e likel y t o b e , intermitten t

and/o r limite dt o particula r owner s alon g th e chai n of individual s wh o ma y ow n agive n vehicle

. Thus , th e propose drequiremen t

fo r accumulatin g mileag e u p t o 6 0 percen t o f avehicle' s o r engine' s usefu l lif

e (unles s stead y stat e i s reache da

f a n earUe r

point ) ma y fa

r excee dth e amoun t

of mileag e an dth e concentratio n of

atypica l emissio n product s whic h woul dgeneraU y b e encountere di n actua l use
. I f so , alowe r mileag e requiremen t

perhap s i n th e rang e o f 25-5 0 percen t

o f th e vehicle' s usefu l Ufe , ma y b e mor e appropriat e i n pursui t of th e stead y stat e condition

. Comment s ar e requeste do n thes e issue s an do n appropriat e mileag e accumulatio n requirements

. Dat ao n typica l consume r

usag e pattern s fo

r atypica l product s woul db e particularl y helpfu l f o thi s decision

. I

f th e comment s ar e supportiv e of

achang e i n th e propose drequirements , EPA woul d expec t t o reduc e th e mileag e accumulatio n require di n th e Fina l Rul e for atypica l fuel s an dadditive s t o a mileag e figur

e i n th e lowe r

rang e mentione dabove

. 2

. Verificatio n Testin g A numbe r

of mechanism s ca n caus e emission s fo.b e capture di n th e dilutio n an dsamplin g syste mbefor e the y ca n b e characterize do r

use dfo r anima l exposures
. Th e rati o of

emission s tha t exi t th e samplin g syste mt o thos e tha t ente r i s calle dth e "recover y factor " of th e system

. Th e recover y facto r mus t b e hig h i n orde r

for subsequen t

emissio n testin g f o b e meaningful

. Determinatio n o f th e recovery facto r

i s calle d verificatio n testing. Verificatio n testin g i s require di n th e FT P usin g propan e o r

carbo n monoxid e fo r gasolin e an ddiese l fuel s an dusin g methano l fo

r methanol-containin g fuels

. I t i s accomplishe db y injectin g aknow n sampl e int o th e dilutio n syste ma t th e en dof th e exhaus t

pip e an dmeasurin g th e amoun t

tha t exit s th e sampl e probe

. Whil e th e performanc e of thi s standar d verificatio n testing wil l determin e i f th e syste mi s leaking , recover y of thes e compound s doe s no t

necessaril y impl y th e recover y of

al l of th e differen t compound s subjec t

f o th e speciatio n
. procedure s of

thi s progra mo r

al l biologicall y significan t

emissio n
. products

. EP

A ask s for

commen t o n whethe r furthe r verificatio n testin g shoul db e require dfo r

thi s progra m usin g additiona l compounds

. I n orde r fo r th e syste mt o b e acceptable , aminimu mrecovery rat e woul db e require dfor

eac h compoun di n a n injecte dsampl e compose do f know n chemical s o

f th e typ e unde r

analysis

. Suc h verificatio n procedure s woul db e relativel y eas y t o performwhe n emission s ar e bein g generate dfo r characterizatio n purposes , sinc e calibratio n compound s an dspeciatio n equipment

woul db e readil y available

. However , whe n emission s ar e bein g generate dfo

r purpose s of

biologica l testing , simplifie dverificatio n testin g ma y b e i n order , sinc e biologica l testin g laboratorie s ma y no t

alway s hav e sophisticate dspeciatio n apparatu s available

. In thi s case , a n injecte d hydrocarbo n sampl e coul db e detecte d wit h aga s chromatograp h an dflam e ionizatio n detecto r

t o estimat e th e recover y factor

. EP

A ask s fo r commen t o n thes e propose drequirement s for verificatio n testing

. 3

. Emissio n Storag e an dTranspor t A s mentione dpreviously , emission s ca n b e store dfor

onl y aUmite dperio d of tim e befor e chemica l change s ma y occur , lhe

. critica l tim e perio di s a functio n o f

th e compositio n of

th e emissions , th e temperature an dpressur e unde r whic h the y ar e contained , th e vesse l i n whic h the y ar e stored , th e amoun t of sunligh t f o whic h the y ar e exposed , an dth e amoun t o f deterioratio n tha t

i s considere d acceptable

. Th e maximu mallowabl e storag e times fo

r emission s whic h ar e t o b e subjecte dt o chemica l analysi s wil l var y dependin g o n th e speciatio n protocol , an dar e identifie di n relevant part s o f th e propose dregulatory text

. Storag e tim e i s no t

a n issu e i n regar d t o biologica l test s usin g whol e combustio n o r

evaporativ e emissions

. . sinc e thes e emission s ar e f o b e generate dcontinuously

. Particulat e phas e emission s ca n b e store du p t o si x months , eithe r

o n th e coUectio n filter

o r afte r extraction , Hi e store dmateria l mus t b e seale di n acontaine r

tha t i s opaqu e t o ultraviole t

light an d maintaine da t

—ZOO C o r

less

. Semi

volatil e phas e emission s mus t b e extracte dimmediatel y afte r collection , store da f —20 0 C an duse dwithi n si x months

. Specia l emissio n handlin g specification s for

biologica l testin g purpose s ar e considere di n sectio n VI.C

. . Comment s o n thes e storag e an d handlin g specification s woul db e welcome

. 4

. Emissio n Generatio n Facilitie s for Biological Testin g Whil e th e continuou s generatio n o f combustio n emission s appear s t o b e a n essentia l componen t

o f th e propose din vivo biologica l tes t

requirements , EP

A i s unawar e of

an y commercia l biologica l laboratorie s whic h offe

r suc h service s a t th e curren t

time

. Installatio n of

th e necessar y vehicle-relate dequipment b y biologica l laboratorie s woul drequir e significan t

capita l expenditur e an d considerabl e tim e for

start-u p an d training

. Similar

problem s woul daris e i

f vehicl e testin g lab s wer e f o instal lP.3 3

1319 8 Federa l Registe r / Vol

. 57 , No

. 7 3 /

Wednesday , Apri l 15 , 199 2 / Propose dRule s biologica l exposur e chamber s adequat e for th e propose dprogram
. EPA ask s fo r commen t o n th e way s i n whic h adequat e facilitie s fo

r th e biologica l testin g requiredb y thi s progra mca n b e mad e availabl e t o th e fuel/additiv e producer s seekin g registration , eithe r throug h increase dfacility availabilit y o r simplifie dtestin g requirements. EP A als o ask s for

comment s an dsuggestions o n wha t remedies ar e availabl e unde r th e Ac t i f adequat e facilitie s hav e no t becom e availabl e whe n testin g i s t o b e conducted

. E. Special Requirements for

Additives 1

. Bas e Fue l Specification s A s discusse di n Sectio n III , fuel additive s subjec t

t o testin g ar e t o b e mixe dwit h th e designate dbas e fuel formulatio n fo r

thei r respectiv e fuel famil y prio r

t o th e generatio n o

f emissions

. Th e bas e fuel formulation s ar e als o propose dt o serv e a s th e representative s fo

r group s i n th e baselin e fuel/additiv e categories

. T o defin e appropriat e bas e fuel formulation s for

th e gasoline , diesel , an d methano l fuel families , EPA propose s t o establis h specification s base do n th e nationa l annua l averag e o f fuel sales

. Fo r thi s purpose , EP

A plan s t o adop t

th e metho dpropose di n th e reformulate d gasolin e rulemakin g (5 6 F R31176) , whic h use s sales-weighte daverage s o f fuel surve y dat at o determin e nationa l averag e parameter s fo

r wintertim e unleade dgasoline

. Th e averagin g procedur e wi

U b e base da t

leas t i n par t o n Moto r Vehicl e Manufacturer s Associatio n (MVMA) fuel surve y data

. I n th e nea r

future , "alternative " fuel s ar e expecte dt o generat e deman dfo r a variet y o f ne w bul k an daftermarke t

fuel additives

. A t

th e presen t

time , however , bas e formulation s for

thes e alternativ e fuel familie s wi

U no t b e defined

. Whe n th e tim e comes tha t

afuel additiv e t o a n alternativ e fuel require s abas e fuel fo r testin g purposes , a n industr y averag e of importan t parameter s i n existin g fuel s wi U b e determine dan dth e bas e fuel specificatio n defined

. Fue l additive s wti l nee dt o b e adde d t o th e "average " fuel s determine db y th e surve y i n orde r

for thes e fuel s t o b e use d i n moto r vehicles

. Example s o f

. necessar y fuel additive s ma y b e stabilizers , deposi t

contro l additives , an dcorrosio n inhibitors

. Onl y additive s determine dt o b e necessar y fo r prope r fuel an dvehicl e functionin g wil l b e component s of

th e bas e fuels

. Thes e additives , alon g wit h thei r in-us e concentrations , wi

U b e determine db y EP A with inpu t

fromintereste d industrie s an dgroups
. A memorandu mentitled , "Bas e Fue l Determinatio n Procedure s for th e Propose dFuel s an dFue l Additive s Rulemaking, " i s availabl e i n th e publi c docket

. Thi s memorandu millustrate s th e propose dapproac h for specifyin g bas e fuel formulation s an dpresent s sampl e value s for

bas e gasolin e an d diese l fuels

. I t

als o discusse s suc h issue s a s bas e fuel blendin g tolerance s an dth e nee dfo r astandar dse t

o f bas e fuel additives

. 2

. Additiv e an dBas e Fue l Emission s Compariso n Emission s fromfuel additive s may , i n som e cases , b e difficul t

t o distinguis h fro mth e emission s o

f th e bas e fuel itself

. Ideally , th e emission s contribute d b y a n additiv e woul db e determine db y performin g test s o n tw o identica l vehicles , on e fuele dwit h th e bas e fuel alon e an dth e othe r

fuele dwit h th e additive/bas e fuel mixture

. Tes t result s o n th e emission s fromth e tw o vehicle s woul db e compare dan dth e differenc e attribute dt o th e fuel additive

. However , significan t

variabilit y ca n exis t

betwee n vehicle s eve n of

th e sam e yea r

an d model

. Furthermore , th e additiona l expenditur e for

conductin g test s o n tw o vehicles , on e wit h an don e withou t th e fuel additive , woul db e considerable

. Nonetheless , from ascientifi c perspective , side-by-sid e testin g woul d b e th e preferre dapproach

. A n alternativ e t o thi s metho di s proposed , i n whic h onl y on e vehicl e mode l woul dgenerat e an dtes t th e bas e fue l emission s for

eac h fuel family , wit h th e result s mad e availabl e for us e a s contro l dat afo

r a U additive s i n th e fue l family

. Standardizatio n o f th e vehicl e make , model , an dyea r

woul db e a n importan t requiremen t

Unde r thi s approach , bas e fuel testin g woul db e don e a s par t

of th e progra m automatically , sinc e th e grou p representativ e fo

r eac h baselin e grou p i s als o abas e fue

l for th e respectiv e fuel family

. Thus , n o additiona l effor t woul d b e requiredo n th e par t

o f th e additiv e producer s i n orde r

t o performth e compariso n analysis

. Thi s metho dcoul d provid e areasonabl e se t

o f contro l dat a fo r compariso n agains t

th e tes t result s
. fo r fuel additive s (both emissio n characterizatio n an dbiologica l studies) , a t afraction of

th e cos t o f th e mor e rigorous approach

. However , th e requiremen t

tha t th e sam e vehicl e make , model , an dmode l yea r

b e use dfo

r testin g th e bas e fuel an dth e additive / bas e fuel mixtur e woul dbecom e problemati c fo

r fuel additive s teste d som e year s afte r

th e bas e fuel wa s tested , sinc e acquirin g ane w (unused ) vehicl e o f apreviou s mode l yea r

woul d b e difficult

. EP

A ask s fo r suggestion s a s t o ho w thi s requiremen t ca n b e effectivel y implemented

. O f course , an y additiv e produce r

coul dconduc t independen t

bas e fuel testin g i n lie u of relyin g o n th e result s o

f th e grou p responsibl e fo

r bas e fuel testing

. I n cas e th e baselin e group(s ) i n som e fuel familie s ar e abl e t o satisf y th e Tie r 1 an dTie r

2 requirements base do n existin g testing , EP

A ask s fo r commen t o n ho w variou s additiv e producer s needin g bas e fuel informatio n coul d wor k cooperativel y for

thes e purposes
. EP A als o request s commen t o n th e appropriatenes s o

f thi s propose d metho dfor

distinguishin g th e emission s effect s of fuel additive s fromth e emissio n effect s o

f th e bas e fuel

. Sectio n V A presente danothe r alternativ e for

comment , i n whic h si x vehicle s woul db e use dt o generat e emission s bot h for

th e additive/bas e fue l mixture s bein g teste dan dfo r th e applicabl e bas e fuel

. Whil e thi s approac h woul dreduc e th e proble mo f vehicle-to-vehicl e emission s variability , i t depend s o n th e vaUdit

y o f th e assumptio n tha t

carryove r

effect s fro

m fuel s an dadditive s use dpreviousl y i n tiie vehicle s woul db e negligible

. T o th e degre e tha t

thi s assumptio n i s valid , th e us e o f th e sam e vehicle s t o generat e emission s for

compariso n might

b e preferred

. 3

. Additiv e Concentratio n Prio r t o emissio n generatio n an d testing , additive s ar e t o b e mixe dwith thei r associate dbas e fuel t o a concentratio n equa l t o tha t recommende db y th e additiv e produce r a s th e maximu min-us e concentration

. On e alternativ e woul drequir e mixin g o f fuel additive s i n thei r

bas e fuel s a t

a
. significantl y highe r

concentratio n tha n th e recommende damount , i.e. , t o "dope " th e mixtur e wit h th e fuel additive

. Anothe r possibl e metho do

f dopin g a n additive/bas e fuel mixtur e woul db e t o significantl y increas e th e concentratio n o f particula r

component s of

a n additiv e produc t (e.g. , th e compound s tha t contai n atypica l elements)

. Th e primar y purpos e o f thes e approache s woul db e t o enhanc e th e contributio n o f th e "*

- additiv e produc t

(o r th e particula r componen t

o f concern ) t o th e emission s produce db y th e additive/bas e fuel mixture

. Thi s woul dfacilitat e th e tas k o f detectin g an danalyzin g th e additive' s emission s an ddistinguishin g the mfrom th e emission s produce db y th e bas e fuel

. I t woul dals o effectivel y increas e th e dosag e o f additiv e emission s durin g biologica l exposure s t o additive/bas e fuel emissions , increasin g th e likelihoo d tha t observabl e change s coul db e detecte di n compariso n wit h exposure sFedera l Registe r / Vol

. 57 , No

. 7 3 /

Wednesday , Apri l 15 , 199 2 / Propose dRule s 1319 9

t o emission s o f

th e bas e fuel alone

. EP

A ask s fo r commen t o n th e mixin g rule s tha t shoul db e adopte dan do n th e validit y o f

dopin g th e bas e fuel wit h th e fuel additiv e o r

activ e ingredient

. Commen t i s als o requeste do n appropriat e additiv e concentratio n levels , i f adopin g procedur e wer e t o b e adopte dfor

th e final rule

. VI

. Evaluatio n o f

Healt h an dWelfar e Effect s Th e scop e an dgenera l structur e of propose dprovision s for

evaluatin g th e potentia l healt h an dwelfar e effect s o f fuel s an dfuel additive s wer e discusse d abov e i n section s III. E an dF

. Th e progra mfocuse s o n th e contributio n of fuel s an dadditive s t o harmfu l ai r pollution , an dinclude s requirement s t o determin e th e compositio n an dpotentia l effect s o f fuel/additiv e emission s generate db y bot h combustio n an d evaporativ e processes
. Healt h effect s testin g provision s ar e specificall y focuse do n th e effect s o

f inhalatio n exposur e t o fuel/additiv e emission s i n regar dt o th e followin g selecte d endpoints : carcinogenicity , mutagenicity , developmenta l effects , reproductiv e effects , pulmonar y toxicity , an dneurotoxicity

. Th e impact s of fuel an dadditiv e emission s o n th e publi c welfar e an dth e environmen t ar e addresse db y dat aresearc h methodologies

. A s previousl y described , th e require d evaluatio n procedure s ar e organize d withi n thre e successiv e tiers. A U fuel s an dadditive s (o r

fuel/additiv e groups ) mus t b e evaluate di n complianc e with th e first tw o tiers

. Tie r

1 include s requirement s fo r th e characterizatio n of fuel o r additiv e emissions , th e compilatio n of

existin g informatio n o n th e potentia l advers e effect s o f th e emissions , an dth e modelin g of exposure , reactivity , an denvironmenta l partitioning

. Tie r

2 i s comprise do f

short

ter mbiologica l screenin g test s for th e specifie dendpoints

. Bot

h th e Tie r 1 emissio n characterizatio n an dth e Tie r 2 biologica l testin g requirement s ma y b e mitigate db y th e demonstratio n o f adequat e existin g testing

. Th e informatio n fromthes e tw o tiers , togethe r wit h othe r

availabl e toxicit y an dexposur e data , wil l b e assesse db y EP A t o determin e whe n furthe r stud y i s neede dt o provid e adequat e informatio n fo r regulator y decision-making

. I n tha t instance , additiona l testin g requirements will b e impose dunde r

th e provision s o f Tie r 3

. Th e specifi c requirement s o f eac h health/welfar e evaluatio n tie r ar e describe di n mor e detai l i n th e followin g sections

. A. Tier 1: Characterization of

Emissions 1

. Scop e of

Characterizatio n Requirement s Th e propose drequirement s for emissio n characterizatio n ar e intende d t o satisf y th e provision s i n Sectio n 21 1 t o "determin e th e emissions " o f fuel s an dadditives , an dt o provid e apartia l inventor y of

potentiall y harmfu l emissio n product s for

furthe r stud y an d evaluatio n i n suppor t

o f program s suc h a s th e Mobil e Sourc e Relate dAi r Toxi c Progra m(sectio n 202(1)(1 ) of th e Clea n Ai r Act)

. I n general , th e required procedure s ar e directe dtowar dth e detectio n an dmeasuremen t of selecte d chemica l classe s an dcompounds

. A complet e an dprecis e characterizatio n of al l emissio n product s woul drequir e tes t protocol s specifi c t o al l possibl e compounds , anearl y impossibl e task

. Fo r thi s reason , th e propose dprogra m focuse s o n measuremen t

o f regulate d emission s an do n th e identificatio n of specifie dclasse s of

compound s o

f interest

. Fo r mos t fuel s an dfuel additives , propose demission s analysi s requirement s ar e limite dt o th e determinatio n o f

th e emissio n rat e o f regulate demission s an dth e speciatio n o f volatil e hydrocarbons , aldehydes , ketones , ethers , alcohols , polycycli c aromati c hydrocarbon s (PAH) , (th e subse t of polycycU c organi c materia l [POM ] tha t

include s onl y hydrocarbons ) an dnitrate dpolycycli c aromati c hydrocarbon s (NPAH)

. Thes e requirement s ar e summarize di n Figure 4

. Fo r fuel s an dadditive s tha t

contai n "atypical " element s (a s define din sectio n IV) , th e chemica l fat e of th e atypica l component s mus t b e determined

. Comment s ar e solicite do n th e adequac y of

thes e propose darea s of analysi s fo r

characterizin g tiie emission s of fuel s an dfuel additives

. Comment s ar e specificall y requeste d o n whethe r

speciatio n of

nitrogen

containin g emission s shoul db e include d a s arequiremen t

fo r fuel s an dadditive s whic h contai n appreciabl e quantitie s of thi s elemen t

Suc h informatio n might

b e o f valu e i n determinin g th e chemica l basi s fo r toxi c effect s whic h might b e observe ddurin g in vivo biologica l testing

. FIGUR E 4.-EMISSIO N CHARACTERIZATIO N REQUIREMENT S

Emissio n typ e R E H C Ket an d Ai d Al e an d

Et h PA H NPA H

Combustio n emissions : Vapo r phas e emission s Semi-volatil e phas e emissions.

. Particulate phas e emission s Evaporativ

e emissions : * Diurna l emission s Hot soa k emission s X- «

X 1 X '

1 Require d I f alcohol s o r ether s exis t i n th e uncombuste d fuel

. 'Onl y applicabl e t o fuels/additive s require d t o measure evaporative emission s RE=regulate d emissions , HC=hydrocarbons , Ai d an d Ket=aldehyde s an d ketone s Al e & Eth=alcohol s an d ethers , PAH=polycycli c aromati c hydrocarbons

. NPAH=nitrate d polycycli c aromati c hydrocarbons

. A s propose di n sectio n V , th e generatio n of

bot h combustio n an d evaporativ e emission s woul dgenerall y involv e equipmen t

an dprocedure s normall y applicabl e t o th e certificatio n o f ne w vehicles

. Thre e bag s o f vapo r phas e an dthre e filter s of particulat e phas e combustio n emission s woul db e collecte dfor

eac h light-duty vehicle

. Fo r heavy-dut y vehicles , on e ba g an don e filte r o f combustio n emission s woul db e collecte ddurin g th e col dstar t an don e ba g an don e filter

durin g th e ho t

star t segment s o

f th e transien t

tes t cycle

. Fo r fuel s an dadditive s subjec t t o evaporativ e emissio n requirements , on e ba g o f diurna l emission s an don e ba g o f ho t soa k emission s woul db e collecte d fromth e SHED

. Unles s otherwis e noted , eac h speciatio n protoco l i s t o b e performe d o n eac h sampl e of

combustio n emissions

. Speciatio n requirements for evaporativ e emission s ar e limite dt o th e analysi s of

hydrocarbons , ethers , an d alcohol s (i

f th e latte r ar e presen t

i n th e fuel/additiv e formulation)

. T o provid e a n indicatio n o

f th e variabilit y of emissions , EP

A propose s tha t

th e entir eP.3 5

1320 0 Federa l Registe r/ Vol

. 57

. Np

. 7 3 /

Wednesday , Apri l 15 , 199 2 / Propose dRule s
emissio n generatio n an d characterizatio n proces s b e performe d thre e times. CoUectio n an dspeciatio n of backgroun dsample s i s no t required

. However , i

f backgroun dsample s ar e no t speciated , th e emission s tha t ar e measure di n th e speciatio n protocol s will b e assume dt o b e entirel y du e t o th e fuel o r additiv e of

interest

. 2

. Emissio n Characterizatio n Protocol s Th e Clean Ai r

Ac t authorize s EP

A t o requir e informatio n t o characteriz e fuel / additiv e emissions , whil e givin g EP A discretio n t o specif

y th e particula r protocol s whic h mus t

b e use dfo

r thi s purpose
. Thus , th e foUowing section s identif y th e genera l emissio n produc t categorie s o

f Interes t an ddiscus s Currentl y availabl e protocol s whic h ar e suitabl e for

thes e purposes
. However , scientifi c method s ca n b e expecte dt o advanc e i n th e nex t fe w years , an dth e us e o f thes e protocol s i s no t

mandated

. Rather , EP

A wi U hol dproducer s accountabl e fo

r state-of-the-ar t

method s an dgoo danalytica l chemistr y an d laborator y practices

. Thes e practice s ar e describe di n th e articl e "Principl e of Environmenta l Analysis" , foun di n Th e Journa l o f Analytica l Chemistry , 1983 , Volume 55

. Th e regulate demission s nee dt o b e measure db y EP A approve d methods

. Curren t

method s ar e describe d i n 4 0 CF R88 ; however , i

f Uies e method s ar e revise do r

ne w compound s regulated , the n method s i n forc e a t th e time th e regulate demission s testin g i s performe dar e th e method s tha t mus t b e use dfo r thi s program
. a
. Characterization of

regulated emissions. Th e term"regulate d emissions " for

thi s progra mrefers t o emissio n product s for

whic h standard s hav e bee n establishe dfo r th e purpos e o

f th e certificatio n o

f ne w moto r

vehicle s (4 0 CF Rpar t 86)

. Vehicle s o

f thre e fue l familie s (gasoline , diesel , an dmethanol ) ar e presentl y require dt o underg o certificatio n testing

. Th e regulate d emission s applicabl e t o eac h family ar e show n i n Figure 5

. Oxide s o f nitroge n an dcarbo n monoxid e ar e regulate d combustio n emission s commo n t o al l thre e fue l families

. Organi c materia l i s regulate di n variou s form s dependin g o n th e vehicl e an dfue

l type

. Particulat e emissions , alread y regulate dfo r diese l cycl e vehicles , wil l b e regulate dfor light-duty Ott o cycl e vehicle s beginnin g i n 1994

. Methanol-fuele dvehicle s ar e teste dfo r methano l an dformaldehyd e a s par t of th e organi c materia l standards

. Evaporativ e emission s fro m ott o cycl e vehicle s an dmethanol-fuele d vehicle s ar e regulate dfo

r organi c material , includin g methano l measuremen t

whe n relevant

.
FIGUR E 5.—REGULATE D EMISSION S

Fue l cycl e

Gasoline/Ott o Methanol/Ott o

_ Methanol/Diese l Combustio n emission s
Tota l H C

1
1 NMH C

2

2 OMHC E

1
1 OMNMHC E

2
2 NOx

' 1

1 1 1 C O

1

1 1 1 P M

2

2 1 1 Evaporativ

e Emission s - Tota l H C

1 OMHC E

1

1
Notes : 1 = Always

. . 2=Afte r 199 4 fo r light-dut y vehicles/truck

s only

. Tota l HC=Tota l Hydrocarbons

. NMHC=Non-Methan e Hydrocarbon

. OMHCE=Organi c Materia l Hydrocarbo n Equivalen t (includes test s fo r HC , methanol , an d formaldehyde)

. OMNMHCE=Non-Methan e OMHCE

. NOx=Oxide s o

f Nitrogen

. CO=Carbo n Monoxide

. PM=Particulat e Matter

.

. Th e regulate demission s ar e t o b e measure dfo

r fuel/additiv e registration purpose s i n th e sam e manne r an dwith th e sam e degre e of

accurac y a s specifie di n 40 CF

Rpar t 8 8 for vehicl e certification , includin g evaporativ e emission s an dcombustio n emission s o f bot h vaporou s an dparticulat e phases

. Onl y thos e regulate demission s include d i n th e certificatio n requirement s fo r th e vehicl e typ e an dmode l yea r use dt o generate.emission s fo

r testin g (selecte d accordin g t o th e criteri ai n sectio n V A ) nee dt o b e determine dfor thi s program
. Th e results o

f thes e test s ar e t o b e reporte di n th e manne r

specifie dfo

r vehicl e certification

. Comment s ar e requeste do n thes e requirements. b

. Hydrocarbon characterization. Speciatio n o

f hydrocarbon s i n th e vapo r phas e o f emission s i s t o b e performe d usin g method s tha t

identit y an d determin e th e concentratio n of al l hydrocarbo n compound s containin g twelv e o r fewe r carbo n atoms

. A n acceptabl e speciatio n method , availabl e i n docke t A-90-07 , i s describe di n th e documen t "Researc h Protoco l Metho d fo r Analysi s o

f Detaile dHydrocarbon s Emitte dfro

mAutomobile s b y Ca s Chromatograph " (June , 1991)

. Th e procedur e i s t o b e performe do n bot h combustio n an devaporativ e emissions

. Hydrocarbo n compound s o f highe r molecular weigh t (i.e. , mor e tha n twelv e carbo n atoms ) ten dt o condens e and/o r adsor b ont o particulat e surface s a t dilut e exhaus t

temperature s an d concentration s an dar e therefor e no t amenabl e t o thi s typ e o

f analysis

. EP

A ask s fo r commen t o n possibl e requirement s for

identifyin g chromatographi c peak s usin g mas s spectroscop y whe n pea k

identit y i s questionabl e an dwhe n coelutio n i s suspected

. c
. Aldehyde and

ketone characterization. Speciatio n of aldehyde s an dketone s i s requiredonl y fo r th e vapo r

phas e o f combustio n emissions , collecte dusin g th e equipment

an dmethod s prescribe di n 4 0 CF Rpar t 8 6 fo r formaldehyde measurement

. A currenti y availabl e procedur e whic h ca n accuratel y analyz e aldehyde s and

. ketone s i s th e ASTM D5197-91 , "Standar dTes t

Metho dfo

r Determinatio n o

f Formaldehyd e an d Othe r Carbony l Compound s i n Ai r (Activ e Sample r

Methodology)"

. Th e speciatio n procedur e involve s th e reactio n o

f aldehyde s with 2,4

- dinitrophenylhydrazin e t o for mstabl e derivative s tha t

ar e analyze db y hig h performanc e liqui dchromatograph y (HPLC) usin g a n ultraviole t ligh t detector

. d

. Alcohol and ether characterization. Alcohols an dether s ar e t o b e analyze d i n combustio n an devaporativ e emission s wheneve r

th e fuel o r

additiv e unde r evaluatio n o r

th e bas e fue

l mixe d with th e additiv e contain s alcohol s o r ethers

. Th e emission s ar e t o b e collecte d an danalyze dusin g th e procedure sFedera l Kegiste r/Vol
. 57 , No . 7 3 / Wednesday , Apri l 15 , 199 2 / Propose d Rule s 1320 1

• - •'

- » .' ' — • prescribe d i n 4 0 CF

Rpar t80 , appendix F , entitle d 'Tes tMetho d fo r Determinatio n of

C1-C 4 Alcohol s and MTB E i n Gasolin e b y Ga s Chromatography"
. Tlii s procedur e ca n b e use d forth e identificatio n o f ether s i n additio n f o MTBE , bu twil l require appropriat

e modification s fo

r applicatio n f

o ga s phas e samples . e . PAH and NPAH characterization. PA H an d NPA H are mutageni c compound s whic h hav e bee n designate d a s a topi c forstud y b y th e Clean Ai rAc t (sectio n 202(1)(1) ) f

o determin e if

thei r emissio n b y moto rvehicle s shoul d b e regulated . PA H an d NPA H are typicall y found i n combustio n emissions , and thei ridentificatio n i n evaporativ e emission s wil l no tb e required under Tie r1 provisions
. I

n th e pas tPA

H and NPA H hav e bee n analyze d primaril y i n th e particulate phase . However , evidenc e no w suggest s tha f th e quantit

y of thes e compound s i n th e semi-volatil e phas e a f th e temperature s encountere d i n dilute exhaus tmay b e important
. For thi s reason, PA

H an d NPA

H wil l b e speciate d i n bot

h semi-volatil e an d particulate phas e emissions
. A tthi s time, EP

A i s proposin g tha

t thes e PAH an d NPA H characterizatio n requirement

s b e appUe

d t o a U organic
base d fuel s an d additives
. However , i t ha s bee n argued tha

tth e combustio n o

f lo w molecula rweigh tfuel s such a s methane , propane , ethanol , and methano l wil l no tgenerate PA H an d NPA H i n significan tquantitie s i f th e vehicle s tha

tgenerate th e emission s are I n prope roperatin g condition
. Comment s an d supporting dat

a ar e thus requeste d o n th e necessit y o f imposin g PAH an d NPAH characterizatio n requirement

s forthes e fuels
. Particulate an d semi-volatil e phas e emission s are f

o b e collecte d a s specifie d i n sectio n V.B . Th e solubl e organi c fraction (SOF) i s f o b e extracte d from th e filteran d polyme rbe d separatel y an d use d i n separate testin g procedures . Protocol s suitabl e for characterizin g PA H an d NPAH hav e bee n publishe d b y th e Coordinating Researc h Council 4 Bot

h method s 1 an d 2 describe d forPAH speciatio n i n thi s referenc e are acceptable , butth e alternate metho d give n forth e detectio n o f NPA H i s no tEP

A request s comment

s an d suggestion s regarding thes e propose d procedures . f
. Characterization of

emissions with atypical elements. A s discusse d i n sectio n IV, fuel s an d fue

l additive s whic h contai n chemica l element s othe r

s CR C Repor tNo . 55 1 (1987

) Chemica l Methods forth e Measuremen

to f Unregulate

d Diesel Emissions
. Coordinatin

g Researc h Council , Inc . 21 9 Perimete rCente rParkway , Atlanta , C

A 30346
. tha

n thos e include d in th e bas e fue l formulation fo

rthei rrespectiv e fue

l family ar e classifie d a s "atypical " formulations
. For th e mos tpart, atypica l product s ar e thos e wit

h elemental components othe rtha

n carbon , hydrogen , oxygen , nitrogen , an d a limite d amoun

tof sulfur
. Som e of

th e atypica l element s containe d i n suc h product s are th e foUowing : Aluminum , Bismuth , Bromine , Cadmium, Cerium , Chlorine , Chromium, Cobalt , Copper, Fluorine , Iodine , Iron, Manganese , Molybdenum , Nickel , Lead , Platinum , Selenium , Sulfu

r(i f presen tI n amount s exceedin g 1,08

0 pp m i n gasolin e formulation s or 0.05 percen ti n diese l formulations) , Titanium , Vanadium , Zirconium , an d Zinc
. I

n additio n t o th e emissio n characterizatio n requirement s describe d i n subsection s a- e above , producers o

f "atypical " fuel s and additive s wil l b e required t o identif y an d measure th e emissio n product s containin g th e associate d atypica l elements . Becaus e o f

th e variety o f potential element s and reaction product s involved , al l o

f th e necessar y chemical analyti c procedure s canno tb e specifie d i n thi s proposal . However , th e procedure s use d mus tb e state-of-the-art an d base d o n soun d analytica l chemistr y principles
. Generatio n of

th e emission s use d for speciatio n of

th e emissio n product

s containin g atypica l element s wa s discusse d i n sectio n V of thi s notice
. T o summariz e briefly , EP

A propose s tha

t combustio n emission s mustb e i n stead y stat e prior t o sampling , suc h that essentiall y al l (a

tleas t9 0 percent) of

th e atypica l element s enterin g th e combustio n chambe rals o exi ti n th e vehicl e exhaust . Stead y stat e i s t o b e determine d b y a mas s balanc e usin g analytica l protocol s determine d b y th e fuel/additiv e manufacturer
. Mileag e accumulatio n driving wil l b e use d t o conditio n th e vehicl e until stead y stat e i s reached . I

f th e atypical elemen tha s no treached stead y afterth e minimu m 25,00 0 mil e requirement, mileag e accumulatio n mustcontinue
. Th e producers involve d wil l determin e whe n t o conductadditional testin g f o se e whe n stead y stat e ha s bee n reached. I f th e emissio n rat

e of th e atypica l compound s ha s no treached stead y stat e withi n 80 percentof

the useful Uf

e o f th e vehicl e o rengine , on e final emissio n collectio n wil l b e performe d an d th e emission s analyze d forcombustion ' product s containin g th e atypica l elements . Th e specia l Tie r1 emissio n characterizatio n requirement s for "atypical " fuel s and additive s wil l b e considere d complete a tthi s poin tunde r th e assumptio n tha

telement s no t emitte d durin g mos to f th e useful lif

e of th e vehicl e probabl y d o no tpos e a significan thealt

h threat. EP A ask s forcomments o n whethe r th e fate o f al l element s othe rtha

n carbon , hydrogen , oxygen , nitrogen , and sulfurshoul d b e determined , o rwhethe r a selec tgrou

p o f suc h element s shoul d b e subjecte d t o thes e requirements
. Also , comment

s are requeste d o n th e propose d requirements fo rdeterminin g th e fat e o f

atypica l element s an d whethe rinitial stead y stat e determination s shoul d b e allowe d prio r f o 25,000 miles
. 3
. Qualit y Assuranc e Th e accuracy of

a testin g progra

m i s a reflection o f

th e repeatabilit

y an d reproducibilit

y o f tes tresults. Repeatabilit

y i s a measure of

th e variatio n of

result s whe n test s ar

e repeate d o n on e se tof

equipmen

twit h al l othe rvariable s constant , whil e reproducibilit

y i s a measure of

th e variatio n of

result s whe n a n experimen t i s performe

d o n differen

tset s o f equipmentwit

h al l othe rvariable s constant . Thi s sectio n propose s th e adoptio n of som e method s f

o ensur e a high degre e of accuracy fo

rth e emissio n characterizatio n program . a . Repeatability. Whil e today' s proposal suggest s thatrepeatabilit y shoul d b e determine d b y replicatin g eac h tes torcalibration , th e emission s from a give n vehicl e ar e themselve s subjec tt o som e variation
. Thus , replicatin g vehicle-base d test s f o measure th e repeatabilit

y o f experimental equipmentand procedure s mightyiel d misleadin g results. A mor e controlle d approac

h woul d entai l testin g a se tof know n compound s periodicaUy t o determin e th e repeatabilit y of tes t procedures . Fo

rthi s purpose , a prepared mixture of

appropriat

e chemical compound s woul d b e subjecte d f o th e protocol s prio rt o testin g th e actua l emissio n sample . Thes e calibratio n test s woul d als o b e performed a tinterval s throughou

tth e testin g of

fuel/additiv e : emission s t

o assur e continual satisfactor y performance
. Suc h test s are commonly use d forcalibratin g chromatograph equipmen tComment s are requeste d concernin g th e us e of thi s o rothe rpropose d method s fo rassurin g repeatabl e speciatio n results, includin g wha tcompound s shoul d b e use d fo r eac h procedure . b . Reproducibility. Reproducibilit y i s sometime s ascertaine d b y implementin g roun d robi n testin g o

f a give n sampl e b y a numbero

f laboratories
. Th e results o f th e roun d robi n ca n determin e th e ' inherentprocedura

l variatio n alon g wit

hP.3 7

1320 2 Federa l Registe r / Vol

. 57 , No

. 7 3 /

Wednesday , Apri l 15 , 199 2 / Propose dRule s
th e qualit y of

th e lab s performin g th e test

. Fo r example , i

f fou r lab s obtaine d simila r results fo r

aknow n solutio n an d on e la b produce dresult s tha t wer e significantl y differen t

th e reproducibilit y coul db e evaluate db y th e result s of

th e fou r simila r lab s an d th e fifth la b coul db e exclude dfrom furthe r testin g unti l th e difference s wer e resolved

. EP A ask s for

comment s o n possibl e arrangement s fo r

participatin g lab s t o performspeciatio n protocol s i n th e contex t of aroun drobi n progra mi n orde r t o determin e tes t

reproducibilit y an didentif

y thos e lab s capabl e o

f performin g th e require dprotocol s with sufficen t accuracy
. T o thi s end , lab s wishin g t o tak e par t

i n th e testin g progra mcoul dvoluntaril y tes t a vehicle' s emission s o r

analyz e a n unknow n sampl e provide db y EP A I f th e results wer e accurate , EP A woul d hav e som e assuranc e tha t th e dat a generate db y th e la b woul db e acceptable

. c
. Audits. EP

A will reserv e th e righ t

t o audi t testin g faciUtie s involve di n th e generatio n an dcharacterizatio n of emission s fo r

purpose s of

fuel/additiv e registratio n s o tha t

th e qualit y of

result s i s assured

. Suc h audit s woul db e organize dan dadministere db y EP A a t it s ow n expense
. Th e audi t procedure s coul dinclud e arequiremen t tha t facUitie s submi t

acomplete d questionnair e i n whic h equipment an d procedura l informatio n woul db e described

. EP

A coul dmak e recommendatioin s base do n th e submitte dinformatio n an dfollo w u p wit h avisi t

t o observ e th e performanc e of th e protocols

. Th e audi t

coul dals o includ e EP

A distributio n o

f "blind " sample s for

analysi s a t

participatin g laboratories

. Th e audi t

woul dno t

hav e th e purpos e o f

certifyin g tha t

th e laborator y i s "EPA approved"

. Ratier , i t woul dhav e th e purpos e of determinin g th e weaknesse s of

lab s an dth e acceptabilit y of

th e lab' s curren t performance

. Comment s woul db e appreciate do n th e implementatio n o f laborator y auditin g practices

. 4

. Othe r Emissio n Characterizatio n Issue s a
. Emissions modeling. Th e Reformulate dGasolin e progra m(5 6 F R 31176 , July 9,1991 ) requires th e extensiv e us e o f

emission s modelin g i n plac e of actua l speciatio n procedure s t o determin e emissio n products

. Thes e model s predic t

th e combustio n emission s fromth e fuel' s composition

. Thi s approac h wa s adopte dbecaus e of it s convenience , cos t

an dexpecte d comparabl e accurac y for

purpose s of

th e program
. Th e "Simpl e Model " of th e reformulate dgasolin e progra muse s a fuel' s RVP , oxygen , benzene , an d aromati c weigh t

percent s t o predic t

th e emissio n rat e of

non-methan e volatil e organi c compounds , benzene , 1,3

- butadiene , formaldehyde , acetaldehyde , an dPOM

. In 1993 , othe r

fuel parameter s wil l b e include di n th e program' s "Comple x Model"

. However , thes e model s fa U fa r shor t o f th e speciatio n requirement s propose dfo r thi s program
. Fo r example , benzen e an d1,3-butadien e ar e onl y tw o of

mor e tha n 100 hydrocarabon s determine db y th e hydrocarbo n speciatio n protoco l propose di n sectio n VI.A.2.b

. Give n th e difference s i n th e goal s an d requirement s o

f th e tw o program s an da genera l lac k

of emissio n dat at o develo p broade r models , i t

ma y no t b e possibl e t o mee t th e requirement s o

f th e presen t rulemakin g usin g emission s modeling

. Thi s ralemaking involve s th e determinatio n of

variou s emission s from awid e variet y o

f fuel s an dfuel additives

. Som e of

th e fuel additive s contai n compound s tha t

ar e no t commo n i n fuels

. Thus , emission s modelin g doe s no t appea r t o b e adequat e for

thi s progra man di s no t

bein g propose da s a n alternativ e mean s fo

r determinin g emissions

. Unti l model s ar e capabl e o f accuratel y predictin g individua l chemica l specie s for

entir e classe s of compounds , EPA regard s emissio n generatio n an dtestin g t o b e th e onl y viabl e alternative

. Nevertheless , EPA requests commen t

o n th e possibl e rol e o f emission s modelin g for

fulfillin g th e emissio n characterizatio n requirement s i n thi s propose drulemaking , especiaU y i n regardt o evaporativ e emissions , whic h see msomewha t

mor e suite dt o modelin g approaches

. I

f us e of th e Simpl e o r Comple x Model s i s supported , EP A request s tha t

afull justificatio n b e provide da s t o wh y th e mode l results shoul db e deeme dt o b e equivalen t t o th e result s achieve dunde r thi s program
. b

. Raw product

testing. Unde r

th e curren t fuel/additiv e registration program , fuel an dfuel additiv e manufacturer s ar e requiredt o detennin e an dreport

th e compositio n of

thei r products

. However , fe w regulations hav e bee n promulgate dgovernin g th e accurac y of

thi s informatio n an ddi e procedure s for

ra w produc t

analysis

. Particula r short comin g i n th e existin g programar e th e underreportin g o f impuritie s whic h ma y b e presen t i n th e fuel s an dfue

l additive s an dth e relativel y broa dreportin g catgegories / criteri apermitte dfor

petroleu mfuel constituents

. Wit h extensiv e emissio n speciatio n requirements no w bein g proposed , i t

ma y b e importan t

t o mor e clearl y prescrib e ra w produc t analysis

. A thoroug h ra w produc t

analysi s alon g with th e speciatio n results woul d provid e abette r

pictur e o f th e combustio n o f

fuel s an dfuel additive s tha n th e speciatio n result s alone

. Becaus e on e sourc e of

emission s i s uncombuste dfuel an dadditives , bette r informatio n o n th e component s of th e ra w product s might

identif y potentia l emission s tha t

ar e no t measure di n th e standar demissio n characterizatio n requirements

. I n addition , ra w produc t testin g woul dgiv e mor e accurat e informatio n b y whic h product s coul db e grouped

. B. Tier 1: Data Research and

Analysis In additio n t o th e emissio n characterizatio n procedure s describe d above , th e requirement s of Tie r 1 includ e acomprehensiv e searc h an d summar y of

availabl e informatio n source s concernin g th e emissions-base d effect s of fuel s an dfuel additive s o n th e publi c healt h an dwelfare

. Dat a modelin g application s ar e als o included

. Thes e requirement s ar e discusse d below

. 1

. Dat aSearc h an dSummary Th e majo r

function s o

f th e dat asearc h ar e twofold

. Th e primar y purpose s i s t o furnis h EPA with ausefu l compilatio n o f existin g informatio n obtaine dfrom previou s studie s o n th e compositio n an d potentia l toxicologi c an denvironmenta l effect s of fuel/additiv e emissions

. Thi s ' bod y o f informatio n i s expecte dt o provid e acontextua l overvie w a s wel l a s specifi c factua l inpu t

fo r future regulator y decision-makin g b y th e Agency

. Fo r

thi s purpose , th e dat a searc h i s t o encompas s availabl e informatio n o n th e chemica l compositio n o f

th e fuel/additiv e emission s an do n a

U emissions-base d healt h effects

. Tha t

is , th e require d informatio n i s no t

restrictedt o th e particula r endpoint s an dexperimenta l protocol s include di n Tie r 2

. Th e secondar y functio n o f

th e dat asearc h i s t o enabl e producer s of

fuel s an d additivie s t o documen t

th e exten t

t o whic h th e emission s characterizatio n requirement s of

Tie r 1 an dth e healt h effect s endpoint s include di n Tie r 2 hav e alread y bee n addresse db y previou s adequat e testing

. T o mitigat e th e testin g requirement s o

f Tier s 1 an d2 , report s o

f suc h previou s testin g wil l nee dt o b e sufficientl y detaile dt o allo w EP A t o judg e th e adequac y of

protocols , techniques , experimenta l design , statistica l analyses , an ddat a interpretation

. T o th e exten t

tha t suc h informatio n i s available , th e dat asearc h shoul dP.3 8

Federa l Registe r

/ Vol

. 57 , No

. 7 3 /

Wednesday , Apri l 15 , 199 2 / Propose dRule s 1320 3
addres s th e chemica l compositio n an d potentia l advers e effect s of whol e combustio n emissions , evaporativ e emissions , an drelevan t

emissio n fraction s (e.g. , vapo r

phas e an d particulat e phase)

. I n addition , informatio n shoul db e sough t for eac h of th e individua l emissio n product s identifie db y th e require demissio n speciatio n procedures , wit h th e exceptio n o

f th e regulate demissions

. I n thi s regard , EP

A request s commen t

o n th e necessit y of

requirin g th e dat a searc h f o b e don e o n identifie demissio n product s whic h ar e designate dCA A title II o r III ai r toxics

. Informatio n considere dapplicabl e t o agive n fuel o r

additiv e include s dat a obtaine dfromth e testin g of emission s fromtha t specifi c produc t

o r fromothe r simila r products

. Product s woul db e considere dsimilar

t o eac h othe r

if the y ar e member s o

f th e sam e fuel/additiv e grou p (a s define dabov e i n sectio n IV ) o r if the y qualif

y f o b e member s of

th e sam e fuel/additiv e group
. Thus , producer s wh o choos e t o participat e i n grou p function s shoul dpoo l informatio n abou t al l membe r

product s fo

r purpose s o f thei r join t submissio n an dshoul dals o mak e us e of

availabl e dat ao n othe r product s whic h ar e no t

enrolle di n th e grou p bu t shar e th e designate d formulatio n characteristic s o f grou p members

. Similarly , aproduce r wh o choose s no t

t o participat e i n th e groupin g syste mshoul dinclud e an y tes t results whic h ma y b e availabl e fo r product s whic h coul dtheoreticall y b e assigne df

o th e sam e grou p a s th e producer' s ow n produc t Informatio n o n th e healt h an d environmenta l effect s of

fuel s an d additive s i s t o b e compile dfrompeer
reviewe dscientifi c journal s an dotiie r literatur e a s wel l a s interna l industr y studies , government-sponsore dreports an dassessments , proceeding s of scientifi c meetings , an dothe r documente dsources
. Report s o f studie s wil l b e evaluate dfor

adequac y usin g standar dEP

A guidanc e document s an d basi c toxicologi c an decologi c principles

. I n general , EP A wil l plac e greate r confidenc e i n studie s tha t hav e bee n subjec t

t o pee r review

. Applicabl e studie s ma y fal l int o a variet y of categories

. Evidenc e for potentia l toxicit y o r

lac k of toxicit y i n expose dhuman s ma y b e availabl e from epidemiologi c studies , clinica l studies , o r cas e reports

. Mor e often , dat awil l b e availabl e fromexperiment s conducte d wit h laborator y animals

. I n general , referencedexperiment s shoul db e concerne dwit h th e healt h effect s o f inhalatio n exposur e t o fuel/additiv e emissions

. However , dat acollecte dfrom studie s usin g othe r route s of exposur e ma y b e include di

f ther e i s sufficien t justificatio n t o extrapolat e th e result s t o inhalatio n exposure
. Short-termi n vitr o tests , comparativ e metabolis mstudies , structure-activit y analyses , an dth e results of exposur e modelin g approache s ar e als o considere d relevant

. I f available , dat afromfiel dstudies , monitorin g exercises , acciden t evaluations , o r

environmenta l simulatio n experiment s shoul db e include dt o characteriz e th e potentia l impac t of fuel/additiv e emission s o n vegetation , livestock , companio n animals , wildlife , aquati c species , soi l organisms , an dnatura l an dsyntheti c materials

. Fiel dand/o r

modelin g studie s o n th e environmenta l an datmospheri c fat e of fuel/additiv e emission s shoul d als o b e included

. I n addition , th e dat a searc h shoul dcove r

studie s concernin g th e contributio n o

f th e fuel/additiv e emission s t o odo r

an dvisibilit y nuisances

. Propose dguideline s fo r

conductin g a comprehensiv e dat asearc h an dpolicie s fo r assessin g th e adequac y of variou s categorie s o f

reference dstudie s hav e bee n drafte di n conjunctio n wit h th e propose dpetitio n proces s for addin g o r deletin g pollutant s f

o th e list s of

ai r toxic s unde r

CA A Sectio n 112(b ) (availabl e i n Centra l Docke t Sectio n A

130 , EP A Docke t No

. A-90-48)

. EP

A propose s t o appl y thes e genera l guidelines , instructions , an dpolicie s t o th e dat asearc h an dsummar y requirements o f

th e fuels/additive s registratio n program
. Consisten t wit h thes e guidelines , asearc h o f appropriat e commerciall y availabl e toxicologi c an d environmenta l dat abase s mus t b e conducte dt o locat e informatio n from publishe dsources
. Th e searc h mus t g o bac k fo r a t leas t fiftee n year s prio r

t o th e dat e o f submission , an dmus t

b e curren t a s of si x month s prio r

t o th e beginnin g of

testing

. List s of

appropriat e commerciall y availabl e dat abase s an d suggeste ddatabas e searc h term s ar e provide di n th e draf

t ai r toxic s petitio n guideline s reference dabove

. Give n th e lon g histor y of

scientifi c experimentatio n wit h som e fuel emissions , commen t

i s requestedo n whethe r th e dat asearc h perio dshoul d exten dbac k

for alonge r perio do f time , e.g. , thirt y years , rathe r

tha n for onl y fifteen years
. Th e informatio n t o b e submitte dt o EP A a s aresul t

o f th e dat asearc h include s th e foUowing items : (1 ) A brie f tex t summar y of

th e genera l finding s ' an dconclusions , (2) aprinte dcop y o f th e output s fromth e databas e searches , includin g referenc e lis t

an dassociate d abstracts , (3 ) complet e documentatio n i n

scientifi c journa l format

of unpublishe d inhous e o r

othe r privately-conducte d studies , an d(4) table s summarizin g th e protocol s an dresult s of

al l cite dstudies , organize db y healt h o r

environmental

. endpoin t an dtyp e of

emissio n (e.g. , combustion , evaporation , an dindividua l emissio n product)

. I n addition , th e
. person(s ) o r

contractor(s ) conductin g th e literatur e searc h an dsummar y mus t b e identified

. 2

. Modelin g Approache s EP A propose s t o requir e th e applicatio n o

f modelin g o r

othe r analyti c method s t o provid e estimate s of ambien t exposure s f

o fuel/additiv e emissions , expecte datmospheri c reactivit y o f variou s emissio n products, , an dpotentia l environmenta l partitionin g o f th e emissions

. Th e principle s an d parameter s t o b e considere di n implementin g modelin g approache s for vehicl e emission s hav e bee n reviewe d i n th e Healt h Effect s Institute' s publication , Ai r

Pollution , th e Automobile , an dPubli c Healt h 8

. Th e choic e of whic h model s t o us e i s lef t t o th e applican t

provide dtha t

th e applicability , assumptions , limitations , an duncertaintie s o f

th e model s ar e clearl y delineated

. Severa l example s for consideratio n ar e describe dbriefl y below

. However , ne w model s ar e unde r developmen t

b y scientist s a t

EP A an d elsewher e an dth e potentia l registrant woul db e require dt o us e up-to-dat e technique s whe n conductin g th e analyse s neede dt o mee t

Tie r 1 requirements

. Comment s an d suggestion s fromth e pubU c concernin g th e selectio n an dapplicatio n o f analyti c method s woul db e appreciated

. Ambient exposures. A microenvironmenta l mode l develope d b y Melvi n N

. Ingall s an dRober t J

. Garb e 6 i s on e possibl e metho d identifie dfor

derivin g preliminar y estimate s of

ambien t exposure s t o
. emissio n products

. Thi s mode l estimate s ambien t concentration s o f

fuel/additiv e emissions , for

eac h gra mof

emission s produce dpe r

vehicl e mil e (o r

vehicl e minute) , fo

r "typical " an d"severe " situation s i n si x differen t microenvironment8 : Residentia l garage ,

5 Sexton
. K

. and Ryan . B.P. , Assessmen to f Huma n Exposur

e to Ai rPollution : Methods , Measurements , and Models.an d Russell , A.G.
. Mathematica

l Modeling of

the Effec to f Emission Source s o n Atmospheri c Pollutan tConcentrations
. In : AirPollution , th e Automobile , and Public Health . (1988 ) Healt h Effect s Institute , Nationa

l Academy Press , Washington , DC
. 8 Ingalls . M.N. an d Garbe , RJ . (1982 ) Ambien t Pollutan tConcentrations fo

rMobile Source s i

n Microscal e Situations
. SAE Technical Paper Serie s 820787
.P.3 9

1320 4 Federa l Registe r/ Vo L 57 , No

. 7 3 /

Wednesday , Apri l 15 , 199 2 / Propose dRule s parkin g garage , roadwa y tunnel , stree t canyon , expressway , an dexpresswa y vicinity

. Unde r

thi s approach , th e ambien t concentratio n factor s provide d b y th e model s coul db e use di n conjunctio n wit h th e measure demissio n rate s fo r eac h fuel/additiv e emissio n produc t t o estimat e th e exposur e potentia l for

eac h emissio n compound

. Specifi c populatio n exposur e characterization s ar e provide db y th e SIMSY S 7 8 an dSHAPE S 9 models

. Eac h of thes e method s use s bot h statistica l an dphysica l approache s t o estimat e emissio n exposure s t o individual s an d t o define dpopulations

. SIMSY S ca n characteriz e hig h exposur e situation s an dSHAPE S ca n b e use dt o mode l exposure s t o maximally-expose do r sensitiv e individuals

. Onc e modelled , actua l exposur e dat aspecifi c t o th e microenvironment s coul db e use dt o validat e th e physica l condition s predicte di n thes e models

. EPA' s Offic e of

Mobil e Source s i s no w completin g th e developmen t o f ane w hybri dexposur e mode l specifi c t o mobil e sourc e emissions

. Th e ne w mode l (HAPEM-MS ) incorporate s element s of

bot h th e Hazardou s Ai r Pollutan t Exposur e Mode l (HAPEM), 1 0 whic h i s mor e pertinen t

t o stationar y sourc e ai r pollution , an danothe r

EP A model , th e Nationa l Ambien t Ai r Qualit y Standard s Exposur e Mode l (NEM). " l 2 Whil e base do n carbo n monoxid e emissions , HAPEM-M S ca n b e use dt o estimat e th e averag e annua l exposur e t o an y mobil e sourc e pollutan t compoun dof

interes t an dexpecte dt o b e highl y applicabl e t o th e emission s exposur e informatio n need s o f thi s program
. A report

describin g HAPEM

M S an dit s use s i s availabl e i n th e publi c docke t

fo r thi s propose d rulemaking. 1 3

' Letz. R. , e tal . (1984

) Estimate d Distributions of Persona l Exposur e to Respirable Particles
. Environ
. Moni L Assess
. 4:351-68
. 8 Ryan. P.B., e tal . (1988

) Estimatin

g Persona l Exposures to Nitroge

n Dioxide
. Environ
. Int

. 12:395
- 400
. * Ot tW.R

. (1983-84) Exposur

e Estimates Base d o n Computer-Generate

d Activit y Patterns . J

. Toxicol
. Clin
. Toxicol
. 21:97-128
. 1 0 Johnson. T. , e tal . Th

e Assessmen to

f Commutin g Pattern s in Applications o

f the Hazardou s Ai rPollutan tExposur e Model . 84t

h Annua l Meetin g o f th e Airan

d Wast e Managemen

t Association , Vancouver, B C Jun e 16-21,1991
. 1 • Johnson

. T . and Paul . R.A
. (1983

) Th e NAAQ S Exposur e Mode l (NEM ) Applied to Carbo

n Monoxide
. PEDC

o Environmental
. Inc. . Durham . N C EPA-450/5-83-004
. * • Ingalls , MM

. (1985 ) Improve d Mobile Sourc

e Exposur e Estimation
. Southwes tResearc h Institute , Sa n Antonio , TX

. EPA-460/3-85-002
. • * Johnson. T. , Paul , R.A. , and Capel
. 1-E
. (1992 J Application o

f the Hazardous Ai

rPollutan t Exposur e Mode l (HAPEM

) t o Mobile Sourc

e Pollutants . Internationa

l Technolog

y Corporation
. Durham . N C EP A Contrac tNo . 88-DO-0062
. Atmospheric transformation. EPA' s

OZIPM 4 I 4 an dUrba n Airshe d" 8 model s ar e usefu l fo

r calculatin g a n ozon e cos t

o r benefi t fro mspecifi c emissions

. I n addition , amode l develope dfo

r EP A an dth e Californi a Ai r Resource s Boar db y WiUia m Carte r 1 9 provide s estimate s o

f th e ozone-formin g potentia l of volatil e organi c compond s (VOCs ) emitte db y vehicles

. Th e Carte r

mode l provide s a se t of scale s representin g th e projecte d incrementa l effect s o

f 140 differen t VOC s o n th e formatio n of photochemica l ozon e unde r avariet y o

f urba n airshe dscenarios

. Knowin g th e weight-percent

concentratio n o

f individua l fuel/additiv e emissio n products , th e "maximu mincrementa l reactivity " scale s ca n b e use dt o estimat e th e amoun t

o f ozon e forme db y thes e chemica l specie s unde r condition s favorabl e t o ozon e production ; However , uncertaintie s i n th e atmospheri c chemica l mechanism s relate dt o man y of

th e emitte dVOC s ma y significantl y affec t

th e accurac y of thes e estimates

. Th e usefulnes s o f thes e model s i s als o limite db y th e fac t tha t the y fai l f o provid e informatio n o n potentiall y harmfu l atmospheri c transformatio n product s othe r tha n ozone
. Thus , EP

A i s als o considerin g a n alternativ e approach

. Rathe r tha n usin g mathematica l models , arequiremen t coul db e establishe dfor

analysi s b y a qualifie dchemis t

o f th e likel y atmospheri c fat e o

f th e emissio n specie s a s aresul t

o f chemica l reactions , deposition , an dothe r

processes
. EPA woul dwelcom e comment s fromth e publi c o n th e suitabilit y o f thes e o r othe r approache s fo

r estimatin g th e atmospheri c reactivit y o

f fuel/additiv e emissions

. A n argumen t

ca n b e mad e tha t requirements fo

r th e modelin g o

f atmospheri c reactivit y woul dlea dt o redundan t

effort s b y man y manufacturers , sinc e considerabl e overla p woul db e expecte di n th e emissio n product s o

f differen t fuel s an d additive s (c r

groups)

. Accordin g t o thi s argument , th e duplicat e effort s coul db e avoide di f EP A itsel f wer e t o ru n th e model s whe n needed , usin g th e emissio n speciatio n dat asubmitte db y th e fuel an dadditiv e manufacturers

. Unde r thi s lin e o

f reasoning , onc e th e dat ao n primary emissio n product s ha s bee n submitted , EP

A woul db e i n th e bes t positio n t o compar e th e emissio n profile s o f

differen t fuel s an dadditives , an dt o us e appropriat e model s t o predic t th e implication s fo

r atmospheri c reactivity

. Whil e thi s argumen t

appear s t o hav e som e validity , i t

als o contain s som e drawbacks

. Firs t

differen t manufacturers ' submission s woul db e receive db y EP

A a t differen t times , interferin g with EPA' s abilit y t o compar e th e emissio n profile s o f variou s fuel s an dadditives

. Suc h comparison s woul db e difficult

t o performi n an y case , an di t

i s Ukel y tha t EPA' s attentio n woul db e draw n t o fuel s o r additive s whic h appea r

t o generat e unusuall y hig h concentration s of

know n precursor s t o harmfu l transformatio n products

. A s a result , fuel s an dadditive s whic h might provid e arelativ e advantag e i n term s of atmospheri c reactivit y woul dten dt o b e overlooked

. Suc h favorabl e result s coul d b e importan t

i n th e overal l evaluatio n o f afue l o r additiv e fo

r whic h certai n advers e effect s wer e als o demonstrated

. In addition , i

f EP A wer e t o perfor

mth e modelin g procedures , manufacturer s woul dlos t

th e initia l opportunit y t o analyz e an dinterpre t

th e modelin g result s an dconclusion s fo r thei r products

. Comment s ar e requeste do n thi s possibl e approach. v Environmental

partitioning. Example s o f model s whic h coul db e use dt o evaluat e th e environmenta l partitionin g o f emissio n product s ar e th e Spatia l Multimedi aCompartmenta l Mode l (SMCM) , " • "develope db y th e Nationa l Cente r for Intermedi aTranspor t Researc h a t

UCLA , an dExposur e an d Ecotoxicity Estimatio n for Environmenta l Chemical s (E4CHEM) , 19

- 2 0 develope db y GeseUschaf t fuer Strahle n (GSF) of

Munich , Germany

. Thes e publicl y availabl e model s predic t th e concentratio n an dmas s fractio n o f pollutant s i n air , soil , water , sediment , an dbiota , thu s indicatin g whethe r terrestria l o r

aquati c organism s ar e potentiall y a t

risk base do n th e

" Hogo , H

. an d Gery, M.W

. (1990 ) User' s Manua

l fo rOZIPM 4 (Ozon e Isoplet h Plottin g wit h Optiona l Mechanisms)
. Volum

e i System s Appli c Inc . San Raphael , CA
. EPA-450/4-89-009a
. 1 5 Morris, RX . e tal . (1990 ) User' s Guid

e fo rth e Urba n Airshed Model . Volum

e I . System s Appli c In c San Raphael , CA
. EPA-450/4/8O-007A
. : 0 Carter
. W.P.L . (1990 ) Developmen

to f Ozon e Reactivit y Scale s fo

rVolatil e Organi

c Compounds
. Statewid e AirPollutio

n Researc h Center , Riverside , CA
. U.S-EP

A Contrac

tCR-814398-01-0
. 1 1 Cohen
. Y . e tal . (1990 ) Dynamic Partitioning of Organi c Chemical s in Regiona

l Environments : A Multimedi

a Screening-Leve

l Approach , Environ
. Sci
. Technol . 24:1549-1558
. " Tsal . W. . e

tal . (1991 ) Hydroge

n Peroxid e Level s I n Lo s Angeles : A Screening-Leve l Evaluation
. Atmos
. Env . 25B:87-78
. '"Trenkle , R

. (1988 ) Fat e Simulation o

f Organi c Substance s in th e Atmospheric Mixin g Layer . In : Environmenta

l Meteorology , K

. Grefe n an d J . Lobe l (eds) , Kluwe

rAcademi c Publishers
. 9 0 Matthies
. M

. e tAl
. (1989) Exposur

e and Ecotoxicit y Estimation fo

rEnvironmenta

l Chemical s (E4CHEM) : Applicatio n o f Fat e Model s fo

r Surfac e Wateran d Soil
. Ecol . Model . 47:115-130
.P.4 0

Registe r / Vol

. 57 , Mo

. 7 3 /

Wednesday , Apri l 15 , 199 2 /Propose dRule s 1320 5
environmenta l partitionin g o f th e pollutant s f

o thes e specifi c environmenta l media

. C. Tier 2 Requirements Th e secon dtie r

o f healt h effect s evaluatio n consist s of

short-ter m screenin g test s whic h addres s th e healt h endpoint s previousl y described

. Thes e test s wil l b e require dfo r

al l fuel s an d additive s f

o th e exten t

tha t th e results of th e dat asearc h activitie s i n Tie r 1 d o no t includ e comparabl e existin g informatio n fromadequatel y performe d an dproperl y documente dpreviou s studies

. Criteri afo r

assessin g th e adequac y of

suc h studie s wer e addresse di n sectio n III.E. 3 of thi s proposal

. BP

A request s commen t

o n whethe r ther e ar e othe r

circumstance s o r produc t characteristic s whic h woul d indicat e tha t

certai n fuel familie s (e.g.

. methan e o r

propane ) shoul db e exempte dfromparticula r Tie r 2 testin g requirements

. Th e propose dhealt h effect s testin g guideline s ar e include di n th e regulatory tex t fo r thi s proposal , availabl e i n th e publi c docke t

o r b y request

t o EP A (se e th e sectio n of

thi s Notic e entitled

. "Fo r Furthe r Information")

. Mos t

of thes e testin g guideline s ar e modifie dversion s of guideline s previousl y publishe dunde r TSC A (4 0 CF

Rpar t 798)

. Method s fo

r performin g anima l inhalatio n exposure s t o fuel/additiv e emission s ar e als o include di n th e propose dregulator y text

. Comment s an dsuggeston s ar e solicite d o n th e adequac y of

thes e propose d guideline s an dmethodologie s for promotin g vaU dstud y desig n an d adquat e technica l performance

. EP A believe s tha t

thes e guideline s (perhap s amende dfor

th e Fina l Rul e a s aresult o f submitte dcommentary) , togethe r with publishe dlaborator y practic e standard s (reference dbelow) , ar e sufficien t t o ensur e tha t

Tie r 2 testin g don e i n conformanc e wit h thes e guideline s wil l b e acceptabl e upo n subsequen t evaluatio n b y EP A However , comment s ar e requeste do n whethe r a n optiona l revie w mechanis mshoul dnevertheles s b e established , enablin g manufacturer s t o submi t detaile dprotocol s t o EP

A for approva l before beginnin g Tie r 2 testing

. Unde r suc h areview process , protocol s reviewe db y EP

A woul dear n a presumptio n o f

technica l adequancy , bu t i h vie w of th e larg e numbe r

of individua l protocol s whic h might

b e submitte dfo

r review , significan t

testin g delay s coul d occur
. Thus , respondent s wh o believ e tha t areview mechanis mi s necessar y o r usefu l ar e aske dfo r

suggestion s o n ho w t o mak e th e proces s operat e efficientl y an deffectively , give n th e statutor y tim e constraint s for

progra mcompliance

. Similar requirements amon g th e variou s test

guideline s i n regar dt o anima l subjects , exposur e scenarios , an dgenera l technica l principle s provid e opportunitie s fo

r concurren t

tes t performanc e a t

considerabl e cos t savings

. Thes e share dstud y parameter s includ e th e following : Laborator y Practice s T o ensur e th e qualit y an dintegrit y o f tes t results, th e performanc e of al l studie s will b e require df o conformwit h th e Goo dLaborator y Practic e Standard s (GLPS ) publishe di n 4 0 CF Rpar t 792

. o r wit h comparabl e standard s whic h ma y b e develope dspecificall y for thi s program
. Thes e GLP S includ e facility , equipmen t

organization , qualit y assurance , an dpersonne l requirements , a s we U a s specification s for

prope r car e o f laborator y animals , handlin g o f reagent s an dtes t

substances , an d conduc t o f studies

. I n addition , th e provision s o f

subpart } o f

par t 79 2 ar e t o b e followe dfor

recor dkeepin g an d reportin g o

f results. Anima l Model s With th e exceptio n of

th e Ame s SalmoneU aassay , th e propose dtes t requirement s entai l th e exposur e of liv e laborator y anirnal s f

o fuel/additiv e emissions

. Mammalia n specie s ar e required, with rodent

specie s recommended

. Th e developmenta l toxicit y stud y call s fo r

th e exposur e an d assessmen t

of tw o species , whil e th e othe r studie s requir e onl y on e specie s t o b e tested

. Anima l facilitie s mus t b e operate di n compUanc e wit h th e Anima l Welfar e Ac t

a s amende dan di n complianc e wit h al l pertinen t USD A regulations

. Exposur e Route s Mos t o f th e propose dtest s ar e base d o n th e inhalatio n exposur e of laborator y animal s f o dilute dwhol e exhaus t

an d evaporativ e emissions

. Suc h studie s require a n exposur e syste mdesigne dt o
. ensur e th e controlle dgeneration , dilution , an ddeliver y o f

emission s t o th e laborator y animals

. T o thi s end , a sectio n of th e propose dregulation s provide s adiscussio n o f

methodologie s for conveyin g eithe r

combustio n o r evaporativ e emission s t o th e tes t animals , exposur e parameter s whic h nee dt o b e monitore dan ddocumente d durin g th e cours e of

th e inhalatio n exposur e period , an danima l car e issues

. Additiona l informatio n o n th e hardwar e requirements , maintenance , an dus e o f emissio n generatio n an dinhalatio n system s ca n b e foun di n "Genera l Healt h Testin g Guidelin e for Inhalatio n Exposur e t o Fuel s an dFue l Additives"

. (Chen g an dBarr , 1991) , availabl e i n publi c docke t

A-90-07

. I n th e cas e ofth e i n vitr o Ame s assay , bacteria l cel l culture s rathe r tha n liv e animal s ar e expose df

o th e tes t emissions

. Thi s assa y i s f o b e performe d usin g prepare dfractions o f combustio n emissions , includin g a n extrac t of filtere dparticulat e matte r 2 1 an da n extrac t o f asorben t

resin whic h trap s semi-volatil e gase s 2S

. Th e Ame s assa y wil l no t b e requiredfo

r evaporativ e emissions

. Exposur e Duration , Dosages , and ' Control s Th e results of

recen t studie s o n inhale dvehicl e exhaus t

mixtures , a s compare dwith simila r

test s usin g concentrate dsolution s o f singl e chemicals , indicat e tha t

exposur e duration s o f

five week s o r

les s ma y riot b e sufficien t

t o induc e observabl e toxicologi c changes

. Traditionally , th e nex t ste p u p i n exposur e duratio n i s t o a 90-da y subchroni c test

. Becaus e o f cos t considerations , however , th e propose d tes t guideline s generaU y ca

U for a minimu msi x wee k

(4 2 day ) exposur e perio dfor a t leas t si x consecutiv e hour s pe r day , seve n day s pe r

week

. EP A request s commen t

o n th e adequac y o f th e propose dexposur e an do n th e potentia l importanc e of

extendin g thes e test s t o 9 0 day s fo r

comparabilit y t o historica l data

. Eac h stud y require s exposure s t o b e conducte da

f aminimu mo f

thre e dilutions , correspondin g t o low

. midrange , an dovertl y toxi c concentrations : A contro l grou p expose d t o filtere dconditione dai r i s als o required

. Th e objectiv e i s t o choose , exposure.level s tiiat

wi U provid e a lowest-observed-adverse-effec t leve l (LOAEL ) an dano-observed-adverse

effec t leve l (NOAEL)

. I n recognition o f th e possibilit y tha t

eve n hig h level s ma y b e nontoxi c provision s ar e mad e for "limi t tests" , wher e appropriate

. Test s conducte dspecificall y for determinin g th e emission s effect s of additives , whic h involv e mixin g th e additiv e wit h a n appropriat e fuel prio r t o emissio n generation , require additiona l contro l studie s usin g th e emission s of

th e bas e fuel alone

. A possibl e mean s of

meetin g th e

3 ' Huisingh , ]
. L. . e tal . Mutageni c an d Carcinogeni c Potenc y o f Extract s o f

Diese l an d Relate d Environmenta l Emissions : Stud y Design
. Sampl e Generation
. CoUection , an d Preparation
. In : Healt h Effect s o f

Diese l Engin e Emissions
. Vol . II . W . E . Pepelko . e tal . (Eds) : U S EPA
. Cincinnati
. 1980
. EPA-eC0/9-60-O57b
. pp . 788-800
. " Stump , F. , Snow
. R- , e tal . (1982 ) Trappin g Gaseou s Hydrocarbon s fo rMutageni c Testing
. SA E Technica l Pape rSerie s No . 820778
.P.4 1

1320 6 Federa l Registe r/ Vol

. 57

. No

. 7 3 /

Wednesday , Apri l 15 , 199 2 / Propose dRule s requiremen t

fo r bas e fue l contro l testin g withou t duplicativ e effor

t wa s discusse d previousl y i n sectio n V

. Brief description s o

f th e propose dtes t guideline s fo

r eac h healt h endpoin t

ar e provide di n th e foUowing sections

. A possibl e alternativ e testin g approac h i s als o described

. 1

. Carcinogenicity an dMutagenicit y Screen s A batter y o f

thre e screenin g studie s i s proposed , a s describe dbelow

. I n thes e studies , mutageni c and/o r carcinogeni c activit y i s indicate db y astatisticall y significan t

concentration-relate d increas e i n positiv e response s afte r exposur e t o fuel/additiv e emission s a s compare dt o control s (i.e. , animal s expose dt o filteredai r

and , i n th e cas e of additiv e testing , animal s expose dt o emission s of

th e bas e fuel)

. Th e detectio n of

areproducible an d statisticall y significan t

positiv e respons e t o a t leas t on e concentratio n of emission s ma y als o b e interprete da s a positiv e result. Ames reverse mutation assay. Th e Ame s assa y i s a n i n vitr o tes t fo r mutagenicit y and , b y implication , for carcinogenicity

. Th e assa y make s us e o f fiv e mutan t

strain s of

th e bacteriu m Salmonell atyphimuriu mwhic h canno t gro w i n amediu mdeficien t i n histidin e du e t o a n inherite dinabilit y t o produc e thi s amin o acid

. Exposur e t o mutageni c (an dpossibl y carcinogenic ) subtance s ca n elici t revers e mutations , suc h tha t th e bacteri aregain thei r

abilit y t o gro w i n ahistidine-deficien t

medium

. I n thi s tes t bacteri awi

U b e expose dt o th e solubl e organi c (semi-volatile ) an d particulat e extract s o

f fuel/additiv e combustio n emissions

. (Ame s test s wil l no t b e requiredfo

r evaporativ e emission s o r

for th e gaseou s fraction o

f combusio n emissions. ) Afte r exposure , th e cell s wi

U b e plate do n histidine / deficien t media , bot h wit h an dwithou t metaboli c activation , an dincubate dfo r adesignate dperio do

f time. Th e numbe r of colonie s (revertants ) growin g o n th e plate s wi U the n b e compare dt o th e numbe r of spontaneou s revertant s i n contro l cultures

. In vivo micronucleus assay. Micronucle i ar e sub-ceUula r structure s containin g chromosomes an d chromosom e fragments no t incorporate d int o th e mai n nucleu s durin g ce U division

. Whil e micronucle i d o for m unde r natura l conditions , exposur e t o potentiaU y carcinogeni c agent s ca n caus e a n increas e i n micronucleate d cells

. I n thi s assay , Uv

e rodent s wil l b e expose db y inhalatio n t o th e fuel / additiv e emissions

. Subsequently , erythrocyte s obtaine dfromth e periphera l bloo d(or , i n rats , fro mth e bon e marrow ) wil l b e sampled , stained ,

an dviewe dunde r

alight microscope

. Th e numbe r

o f normochromati c erythrocyte s containin g micronucle i wil l the n b e counte dan dcompare dwit h normochromati c erythrocyte s from untreate danimals

. Th e us e o f erythrocyte s i n thi s procedur e facilitate s th e visualizatio n o

f micronuclei , sinc e thei r primar y nucleu s i s normall y extrude ddurin g ce

U development

. In viro sister

chromatid

exchange (SCE). SCE s ar e believe dt o b e cause d b y chromosom e stran dbreakag e resultin g i n exchange s of geneti c materia l betwee n th e halve s of a chromosom e "pair " (i.e. , th e chromatids)

. Whil e som e SCE s occu r normally , a n increas e i n th e frequency of suc h exchange s ma y b e indicativ e o f mutagenic/carcinogeni c activity

. I n thi s assay , animal s whic h hav e undergon e inhalatio n exposur e t o vehicl e emission s wil l b e sacrifice dan dperiphera l bloo d lymphocyte s a s wel l a s ceU s fromlun g tissue will b e isolate dan dcultured

. Th e ceU s wil l b e treate dwit h aDN A bas e analo g (bromodeoxyuridine , BrdU ) an d wit h aspindl e inhibito r

suc h a s colchicine

. Afte r

appropriat e stainin g fo r labele dDN A siste r

chromati d exchange s wU

l b e score dfromcell s arreste di n th e secon dmitoti c divisio n an dth e result s compare dwit h appropriat e controls

. 2

. Developmenta l Toxicit y (Teratogenicity ) Stud y Thi s stud y i s designe dt o provid e informatio n o n potentia l danger s t o th e unbor n whic h ma y aris e frominhalatio n exposur e of

th e femal e t o fuel/additiv e emission s durin g pregnancy
. Pregnan t animal s wil l b e expose dt o emission s durin g th e majo r

orga n developmen t perio di n th e fetu s (e.g. , day s 6-1 5 for rat s an dmice)

. Th e dam s wi U b e sacrifice do n th e da y prio r t o norma l parturitio n an dth e uteru s examine dfo r embryoni c o r

feta l deaths

. Viabl e fetuse s will b e examine dfor skeleta l an dsof t tissu e anomalies

. Thes e result s wi U b e evaluate drelative t o th e numbe r o f spontaneou s embryoni c o r feta l death s an dabnormalitie s i n appropriat e controls

. Th e initiaU y propose dtes t guideline s fo

r developmenta l toxicit y call s fo r tw o differen t

specie s t o b e examined

. However , EP

A ask s fo r commen t o n whethe r

on e specie s woul d b e sufficient

fo r th e screenin g purpose s o f Tie r 2

. 3

. Reproductio n an dFertilit y Scree n Th e purpos e o

f thi s test i s t o determin e th e potentia l reproductiv e toxicit y t o adul t

mal e an dfemal e animal s cause db y inhalatio n o f fuel / additiv e emissions

. Bot

h male s an d female s will b e expose dt o th e

emission s throughou t

a n initia l 42-day exposur e period

. In females , vagina l cel l smear s wil l b e examine dthroughou t thi s time , t o trac k

effect s o n th e estrou s cycle

. A t th e en do

f th e initia l exposur e period , asufficien t

numbe r o f female s wil l b e mate dt o obtai n a t leas t te n pregnan t females

. Histopathologica l examinatio n o

f th e uteru s an dovarie s wil l b e performe do n th e non-pregnan t females , whil e th e adul t

males.wil l b e evaluate db y gros s an d histopathologica l examinatio n o f th e reproductiv e organ s an db y assessin g th e number , morphology , an dmotilit y o f sperm
. Pregnan t

female s wil l continu e t o b e expose dt o th e tes t

atmospher e throughou t

th e pregnancy , an dwill b e examined , alon g wit h thei r offspring , a t th e tim e o f birt h an da t

fou r day s post

partum

. A s compare dwith appropriat e contro l animals , positiv e result s woul dinclud e change s i n th e numbe r

an dtyp e o

f cell s seen , i n vagina l smears , decrease s i n sper mnumbe r

o r motilit y o r abnormalitie s o

f sper mstructure , an d pathologi c change s foun ddurin g gros s o r microscopi c examinatio n of mal e o r femal e reproductiv e organs
. A decreas e i n th e numbe r

o r viabilit y o

f offsprin g woul dals o b e evidenc e o f toxicity

. 4

. Pulmonar y Toxicit y Scree n Thi s stud y involve s asix-wee k inhalatio n exposur e o

f laborator y rodent s t o fuel/additiv e emissions , with subsequen t

examinatio n o

f lun g tissue s an dcells

. A satellit e grou p of rodent s (wit h contro l animals ) wil l b e expose d t o th e highes t

concentratio n of emission s i n th e stud y fo r onl y on e week

. Lung lavag e wU

l b e performe do n th e satellite , grou p t o obtai n alveola r macrophage s fo

r assa y of phagocyti c activit y an dfluid s for

biochemica l analysis

. Positiv e result s a t th e en do f th e exposur e perio dwoul db e indicate d b y elevate denzym e o r

tota l protein..

. levels , elevate dnumber s o f cel l type s normall y foun di n th e lungs , alo w inde x o r lac k o f phagocyti c activity , an d abnorma l gros s o r

histopathologica l findings relativ e t o appropriat e contro l animals

. Persistenc e o r

delaye d occurrenc e of

toxi c effect s beyon dth e exposur e perio dwoul dals o indicat e positiv e results

. 5

. Neurotoxicit y Scree n Th e propose dscree n for

neurologi c effect s i s afunctiona l observationa l neurotoxicit y batter y (FONB ) whic h i s t o b e performe do n liv e animal s periodicall y throughou t

asix-wee k perio do f inhalatio n exposur e t o fuel / additiv e emissions

. Usin g standardize dP.4 2

Federa l Kegiste r

/ Vol

. 57 , No

. 7 3 /

Wednesday , Apri l 15 , 199 2 / Propose dRule s 1320 7 procedure s an dbot h positiv e an d negativ e control s t o minimiz e observe r variability , th e functiona l batter y wil l includ e th e assessmen t

o f autonomi c activity , alertness , gros s movement , behavior , gait , gri p strength , an d reactivit y t o genera l stimuli

. A s compare dwit h th e controls , positiv e result s woul dinclud e an y o f th e followin g response s an dchanges : Unusua l bod y position , activit y level , coordination , gai t

o r behavior , tremor s o r convulsions , increase dlacrimatio n o r salvation , piloerection , pupillar y changes , unusua l respiration , diarrhea , increase dof

decrease durination , unusua l vocalization , an ddecrease d gri p strength

. T o completel y asses s th e neurotoxi c potentia l of

comple x fuel/additiv e emissions , additiona l functiona l an d neurdhistochemica l test s woul db e necessary
. Use dalone , th e FON B ma y overloo k advers e effect s a t

th e cellua r level

. Thus , EP

A request s commen t

o n whethe r a n i n vitr o assa y fo r determinin g th e leve l o f

glia l fibrillary acidi c protei n (GFAP) *»•* * shoul db e require di n additio n t o th e FON B t o broadl y asses s sensitiv e neurohistopathologi c effect s i n tes f animals

. Anothe r

alternativ e i s f

o delet e th e FON B an dt o addres s neurotoxicit y b y requirin g onl y th e GFA P assay
. Th e GFA P assa y i s asensitiv e indicato r o f advers e neurotoxicologi c effects

. Becaus e i t

i s a n in vitro tes t

whic h ca n mak e us e of

brai n tissue harveste dfrom expose danimal s use di n othe r studies , i t i s als o arelativel y inexpensiv e option

. EP A request s commen t

o n thes e alternativ e approache s fo r Tie r 2 testin g o f neurotoxi c effects

. 6

. Optiona l Histopatholog y If th e Tie r 1 literatur e searc h o r emission s characterizatio n sugges t th e potentia l fo r

toxicit y t o othe r

orga n systems ; the n histopatholog y of th e indicate dorgan s shoul db e performed , usin g th e animal s expose di n th e pulmonar y toxicit y screen
. Fo r ekample , i f advers e effect s t o th e live r appea r likely , a s suggeste dfromth e literatur e o r th e presenc e o

f hig h level s of

PAH s i n th e emissions , the n i t

woul db e advisabl e t o perfor

mhistopatholog y o

f th e liver

. O n th e othe r

hand , if scientificall y soun dstudie s reporte di n th e literatur e indicat e n o o r ver y minima l potentia l for

hepati c effects , the n live r examinatio n woul dno t

b e

" In : Pesticid e Assessmen tGuidelines , Subdivisio n F , Neurotoxicit y Tes tGuideline s (1991)
. EPA-540/09-91-123
. " OCallaghan ; j.P
. (1991 ) Quantification of Glia l Fibrillar y Acidi c Protein : Compariso n o f Slot
Immunobindin

g Assay s wit

h a Nove l Sandwic

h ELISA
. Neurotoxicology an d Teratology , 13:275-281
. necessary
. Othe r orga n system s likel y t o b e o f concer n includ e th e kidney s an d th e endocrin e glands

. Thes e additiona l examination s ar e suggeste dbecaus e findings o f potentia l advers e healt h effect s i n Tie r

1 might requir e follow-up a t th e Tie r 3 level , an di

f performe da s adjunct s t o require dTie r 2 testing , thes e optiona l histopatholog y examination s might provid e substantia l incrementa l informatio n a t

arelativel y lo w incrementa l cost

. A t

aminimum,.organ s o f potentia l concer n shoul db e removed , weighed , an dsave di n storag e fo r potentia l histopathologica l examinatio n a t afuture time

. However, , th e length o f tim e whic h organ s ca n b e store dan d stil l b e o f us e i s limited

. EPA requests commen t o n whethe r

histopathologica l examinatio n o

f th e liver , kidneys , an d endocrin e gland s a s a n adjunc t t o th e pulmonar y toxicit y screenin g tes t shoul d b e require drathe r

tha n optional

. 7

. Alternativ e Testin g Approac h A n alternativ e approac h unde r consideratio n b y EPA i n plac e o f som e o f th e propose dTie r

2 test s describe d abov e i s amodifie dversio n o f a protoco l develope dfor

us e b y th e Organizatio n fo r

Economi c Cooperatio n an dDevelopmen t

(OECD)

. Th e protocol , whic h wa s develope dfor us e i n th e OECD' s Screenin g Informatio n Dat aSe t (SIDS ) testin g progra mo n hig h volum e chemicals , i s ascreenin g tes t whic h wa s initiall y develope di n th e U.S

. b y expert s fromth e governmen t

industry , academia , an denvironmenta l groups
. I t i s presentl y i n us e fo r

certai n toxicolog y application s b y 1 4 countrie s whic h ar e member s of

th e OECD a s we

U a s b y EPA' s Offic e of

Toxi c Substances

. Th e standar dprotoco l i s designe da s a single-stud y scree n for

repea t dose , reproductive , an ddevelopmenta l effects

. Currently , effort s ar e underwa y a t EP A t o ad dneurotoxicit y measure s t o th e protocol , a s well

. Documentatio n about ' th e SID S protoco l i s availabl e i n th e publi c docke t

for thi s rulemaking

. Whil e th e SID S protoco l might nee d som e furthe r

modificatio n t o accommodat e exposure s b y inhalatio n t o fuel/additiv e emissions , i t coul d potentiall y b e use di n plac e o f th e pulmonary , reproductive , developmental , an dneurotoxicit y screenin g test s describe dpreviously

. I n performin g th e SID S tes t bot h mal e an d femal e rat s woul db e expose dfo r a45

- da y period

. Male s woul dthe n b e examine dfo r

repea t dos e (includin g pulmonary ) effects , reproductiv e effect s (spermnumber , sper mmorphology , histopatholog y of

th e testis , etc.) , an d neurotoxicity

. Female s woul db e evaluate dfo r

reproductiv e performance

. developmenta l effect s and , possibly , pulmonar y effects

. Whil e som e o

f th e propose d individua l test s coul db e performe d simultaneousl y i n orde r

t o reduc e emissio n generatio n an dexposur e costs , th e SID S stud y evaluate s th e fou r specifie dhealt h effect s endpoint s i n a singl e protocol , an dmight offe r additiona l cos t

savings

. O n th e othe r hand , th e SID S stud y i s mor e comple x an dth e result s woul dinclud e somewha t les s informatio n for

eac h endpoin t

i n compariso n with th e propose d individua l tests

. Comment s ar e requeste dconcernin g th e us e of th e modifie dSID S stud y a s asingle-protoco l substitut e for

th e four specifie d individua l screenin g tests

. D. Tier 3 Requirements Fuel s an dadditive s would.b e subjec t t o additiona l testin g unde r th e propose d Tie r 3 provision s of

th e registratio n progra ma s determine do n acase-by

cas e basi s b y EPA

. Th e endpoint s t o b e addresse dan dth e natur e ofth e studie s t o b e performe dwoul ddepen do n th e cas e a t hand

. Sinc e th e overal l objectiv e o f th e progra mi s t o adequatel y characteriz e th e risk

of exposur e t o fue

l an dfuel additiv e emissions , th e applicabl e Tie r

3 requirement s coul d includ e chemica l analyses , healt h studies , and/o r

exposur e studies

. A s discusse di n Sectio n III , thes e test s woul dmos t

ofte n b e require dt o furthe r explicat e th e results o

f th e screenin g batterie s performe dunde r Tie r 2 , bu t might als o addres s othe r

area s of concer n highUghte db y th e Tie r 1 literatur e searc h o r

emissio n characterizatio n procedures

. Th e nee d fo r Tie r 3 testin g woul ddepen do n whethe r sufficient toxicit y an dexposur e informatio n wer e availabl e t o determin e whethe r us e pf afuel o r fue l additiv e
. present s a n unacceptabl e healt h risk

. Th e criteri afo

r thi s determinatio n ar e discusse dbelow

. Whe n adeterminatio n ha s bee n mad e tha t Tie r 3 testin g wi

U b e required , EPA wil l infor mth e responsibl e producer(s ) b y certifie dmai l o

f th e purpos e an d natur e of th e testin g t o b e performed

. Subsequently , relevant

stud y guideline s an datimetabl e fo r

completio n of

a U requirement s wi

U b e specified

. Th e producer(s ) wil l b e expecte dt o submi t detaile dprotocol s for

review an d approva l b y EP

A prio r t o beginnin g th e tests

. Tie r 3 testin g performe di n full conformity wit h aprotoco l pre-approve d b y EP A for th e give n product(s ) an dtes t objectiv e wi

U b e deeme dsatisfactor y complianc e wit h th e Tie r 3 testin g requirement

.P.4 3

1320 8 Federa l Registe r/ Vol . 57 , No , 7 3 /

Wednesday , Apri l 15 , 199 2 / Propose d Rule s
1
. Nee d fo rDiscretionary Tie r3 Determination s Give n th e variet

y o f evaluatio n methodologie s an d subject s include d i n Tier s 1 an d 2 and th e wid e rang e o f possibl e interrelate d outcome s which coul d b e obtained , EP

A believe s tha

ti t i s neithe rpractical no rnecessaril y desirabl e t o specif

y precis e an d exclusiv e criteri a whic h woul d automaticall y caus e fuel s and additive s t o b e subjec tt o Tie r3 requirements
. I n nearl y a U cases , decision s o n th e nee d fo rTie r3 wil l ultimatel y depen d o n expertscientifi c judgmen ta s t o th e qualit y o f th e evaluatio n of

potential health risk s whic h woul d b e possibl e from th e avaUabl e data an d tiie nee d for mor e definitiv e informatio n i n developin g futur

e regulator

y strategies
. Case-by-cas e judgment

s woul d b e expecte d t o play a significan trol e i n determinin g i

f Tie r 3 i s required eve n at th e extreme s of

possibl e Tie r1 and 2
. outcomes . Fo

rexample , a hig

h potential exposur e combine d with positiv e Tie r2 tes tresult s migh

tno tnecessaril y cal l fo

r Tie r3 follow-u p i

f literature searc h or othe rsupporting informatio n wer e avaUabl e t

o adequatel y characteriz e th e potential pubU

c healt h risks involved
. Conversely , relatively lo w estimate d exposure s an d equivoca l tes tresults migh tno tremove th e nee d forfurthe r evaluatio n i

f th e tes tresult s wer e inconsisten twith othe ravailabl e information o

rwit h know n emissio n produc ttoxicitie s o

ri f exposure s wer e expecte d t

o ris e significantl y i n th e future
. I n general , becaus e o

f thei r potentiall y widesprea d distributio n an d use , mos tfuel s and high-volum e bul k additive s woul d hav e a sufficientl y hig h exposur e potential t

o indicat e a nee d for Tie r3 testing , provide d tha tTie r 1 and 2 data suggeste d th e likelihoo d of advers e healt h effects
. Th e discretionary natur

e of th e decisio n proces s mean s thatth e elevatio n of

a produc t(orgrou p of products ) t

o Tier3 nee d no tinvariabl y lea d t o studie s o

f chroni c duration
. Dependin g o n th e endpoints and protocol s involved , additiona l short
ter m analyses , subchroni c toxicity tests , and/o rpharmacokineti c studie s migh t b e sufficien tt

o clarif y risks o ralla y concerns . Becaus e Tie r3 requirements ar e propose d t

o b e applie d o n a discretionary basis , an d becaus e th e scop e o f such requirement

s coul d b e tailore d t o addres s individual circumstances , th e Tie r3 mechanis m woul d hel p t

o ensure thatfinancial resource s an d laborator

y capacit y woul d b e investe d ir

i area s o f rea l concern . A possibl e alternativ e approac h woul d involv e th e establishmen tof

automati c "triggers" , i.e. , specifi c outcome s o

f Tier s 1 and 2 which woul d make Tie r3 testin g mandatory . Associate d Tie r3 testin g requirements woul d als o b e specifie d in advanc e fo

r eac h trigger
. T o ensure tha t significantconcern s woul d no tb e overiooke d underthi s approach , however , relativel y conservativ e condition s woul d nee d t o b e designate d t o serv e a s th e Tie r3 triggers , and relativel y stringenttestin g scenario s specifie d a s automati c follow-u p regimens
. A s a resul tTie r3 migh tb e triggered mor

e frequently an d migh

t inclad e mor

e rigorous testin g requirement

s thatwoul d occu runde r th e propose d discretionary approach . O n th e othe rhand , a syste m of automati c Tie r3 triggers an d tes trequirement s woul d bette renabl e manufacturers t o predictand pla n forthei rmaximu m registratio n responsibilitie s and woul d simplif y EPA' s data evaluatio n tasks . EP A requests commento n th e relative merit s o f th e discretionary vs . automati c approache s fordeterminin g Tie r3 applicability
. Respondents wh o prefer th e automati c approac

h ar e als o aske d forsuggestion s a s t o th e specifi c "triggers " an d foUow-u

p test s whic h shoul d b e established
. • Whil e EP

A propose s t

o retain discretio n i n th e decisio n t o require Tie r 3 testing , i ti s possibl e t

o predictsom e set s of circumstance s whic h woul d indieat e tha

tTie r 3 wil l not

b e required. Thes e factor s ar

e discusse d i n th e section s whic h follow
. EP A requests comment s o n thes e circumstances , an d ask s forsuggestions-o n othe r combination s of

criteri a ("brigh

tlines" ) whic h coul d b e establishe d t o determin e thatconsideratio n fo

relevatio n t

o Tie r 3 i s unnecessary . 2
. Criteria forEscalatio n t o Tie r 3 Thi s sectio n present s som e o f th e guideline s an d consideration s whic h EP A Woul d us e i n determinin g th e necessit y foradditional testin g undera discretionary Tie r3 testin g approach . Consisten twith th e propose d discretionary decision-makin g proces s fo rHe r 3 , thi s discussio n i s no tintende d t o provid e a n exhaustiv e d rdefinitiv e listin g o f relevantcriteria
. Rather, th e majorpurpos e of

thi s discussio n i s t

o hel p furnish a basi s fo

rmeaningfu

l publi c comment

s and suggestion s o n th e propose d Tie r3 provisions
. The decisio n t

o require manufacturer

s t o submitadditional testin g o n th e healt h effects o

f fue l and fuel additiv e emission s woul d tak e into accoun tth e cumulativ e information provide d b y Tiers 1 an d 2 , includin g previou s scientifi c data , emission s characterizatio n data , modelin g outcomes , and biologica l tes tresults . Thus , decision s t

o requir e Tie r3 woul d b e mad e onl y afterth e requirement s of Tier s 1 and 2 hav e bee n adequatel y filled
. Adherenc e t

o thi s principl e wil l preventunnecessaril y costl y or poorl y targete d decision s base d o n piecemeal , out-of-contex tinformation , and wil l promot e mor e precis e identificatio n and evaluatio n of

dat a gap s an d mor

e cost efficientcoordinatio n o

f potential tes t requirements
. Ultimately , EP

A mustb e abl e t o decid e whethe rth e us e of a fue l o r additiv e i s likel y t

o creat e unacceptabl e healt h risks. I f thi s decisio n i s mad e possibl e b y th e informatio n from Tier s 1 an d 2 , the n Tie r 3 woul d no tb e needed ! However , i

f such a risk decisio n canno t b e mad e o n th e basi s o

f th e Tie r 1 an d 2 data , the n Tie r3 testin g woul d b e required. Therefore , t

o make a ' determinatio n o n th e nee d fo rTie r3 testing , EP

A scientist s woul d evaluat e th e exten tt o whic h th e results o f Tier s 1 and 2 wer e adequate fo

rsuch decisions , guide d b y th e basi c principle s o f risk assessment . A risk assessmen tinvolve s th e mergin

g of a healt h effects assessmen t(includin g hazard identificatio n an d dose-respons e relationships ) and a n exposur e assessment . Such a n assessmen tca n range fro m a qualitativ e t

o a highly quantitativ e analysis , dependin g upo n th e exten to

f th e availabl e data . I n mos tcases , a highly quantitativ e assessmen twoul d probably notb e possibl e atth e en d o

f Tie r2
. However , Tier s 1 an d 2 migh

tindicat e tha

tlittl e hazard i s presen tan d tha tsuch exposure s ar

e quit e lo w an d limite d geographically
. I

n such a case , there woul d b e littl e reason t

o pursue furthe

r testin g atth e Tie r3 leve l t o improve dose-respons e information
. I n anothe r example . Tier s 1 an d 2 migh tsugges t tha ta hazard i s likel y an d tha t exposure s appea rsignificant , butth e - data ma y stil l b e inadequate fora quantitativel y advance d risk assessment . I

n thi s case , Tie r3 testing , targete d t o provid e th e missin g information , woul d b e indicated
. I n thi s way , th e principle s and critical dat a element s of

th e risk assessment proces s woul d provid e a useful guid e fo r identifyin g significan tinformation gap s and determinin g th e specifi c objective s o f potential Tie r3 testing
. However , EP A doe s notinten d t

o conducta forma

l risk assessmen ta s par

to f it s decisio n o n whethe rt o promot

e a fue l orfue l additiv e (orgroup ) t

o Tie r3
. Rather , EP A woul d evaluat e th e qualit y an d certaint y o f availabl e toxicity an d dose
respons e data an d conside rqualitativel yFedera l Registe r / Vol

. 57 , No

. 7 3 /

Wednesday , Apri l 15 , 199 2 /Propose dRule s 1320 9

whethe r estimate dexposur e weigh s in favo r o f o r agains t furthe r testing

. O n thi s basis , EP

A woul ddetermin e whethe r additiona l informatio n i s necessar y t o adequatel y asses s th e ris k of fuel o r additive

. A formal risk assessmen t

woul db e mor e likel y t o b e develope dlate r

i f ther e wa s anee dfo

r actio n t o contro l o r

prohibi t aproduc t unde r th e regulator y authorit y o f sectio n 211(c)

. Th e followin g sectio n discus s th e ke y factor s whic h EPA woul dconside r i n identifyin g th e nee dfor

an dconten t

o f Tie r 3 testing

. a. Statistical

issues. A s previousl y mentioned , scientifi c judgmen t wil l b e exercise di n determinin g whethe r Tie r 3 test s ar e necessar y and , if so , whic h ones
. A n importan t

facto r i n suc h judgment s wi

U b e th e interpretatio n of an dsignificanc e ascribe dt o "negative " result s obtaine di n Tier s 1 an d2

. Evaluatin g negativ e dat a(i.e. , no-effec t data ) ca n b e mor e difficult tha n evaluatin g positiv e data , becaus e question s ofte n aris e a s t o th e reaso n fo r th e negativ e result : Di daspect s of th e experimenta l desig n (e.g. , ver y sma U number s of

animals ) lea dt o th e negativ e outcom e o r

wa s th e tes t

substanc e inherentl y of

ver y lo w o r

n o toxicity ? Thi s specifi c questio n i s addresse d statisticall y b y considerin g th e probabilit y of

Typ e I an dTyp e II errors
. A Typ e I erro r

occur s whe n afals e positiv e conclusio n i s made , whil e a Typ e II erro r

i s afals e negativ e conclusion

. Th e acceptabilit y of a specifi c Typ e I I erro r

i s relatedt o th e acceptabilit y o f

fals e negative s i n th e particula r stud y bein g performed

. Fo r example , from atoxicologica l perspective , screenin g assay s ofte n hav e arelatively hig h probabilit y o f producin g fals e negativ e outcomes , sinc e som e majo r

aspect s of

orga n o r tissu e toxicit y ar e no t

bein g examined

. Thus , a n acceptabl e Typ e I I erro r for screenin g assay s woul dtypicall y b e low

. However , th e leve l o f Typ e II erro r considere dacceptabl e shoul db e tempere db y th e goa l of

th e study

. A highe r fals e negativ e conclusio n (e.g. , Typ e I I erro r

o f 0.2) Wouldgenerall y b e acceptabl e i f

i f referredt o a n effec t

of minima l severit y a t

ahigh-exposur e tes t leve l relative t o ambien t

concentratio n an dif fe w peopl e wer e likel y t o b e exposed ; lh e convers e woul dals o hol d true

. A numbe r

o f factor s increas e th e complexit y of

thes e statistica l issues

. Fo r example , -th

e desig n of

th e stud y wil l influenc e th e Typ e I an dI I level s obtaine dan dth e standar dstatistica l method s chosen

. Therefore , th e scientifi c qualit y of

th e statistica l analyse s an dthei r

relationshi p t o th e experimenta l desig n ar e quit e important

.

For example , althoug h minimu msampl e size s ar e specifie di n th e propose d regulations , thes e ar e onl y genera l guidelines

. Variabilit y betwee n laboratorie s an dth e specific s of tiie stud y method s ma y allo w adecreas e o r requir e a n increas e i n sampl e size

. Thes e possibilitie s shoul db e evaluate d properl y befor e th e star t

of th e study

. I n summary , scientificall y soun d statistica l analyse s ar e acrucia l par t o f an y goo dstud y an dwill provid e ke y informatio n for

EP A t o us e i n formin g judgment s o n whethe r

o r no t Tie r 3 testin g i s needed

. Whil e i t i s no t feasibl e t o lis t al l possibl e scenario s an dresult s for eac h Tie r

2 endpoin t

th e foregoin g discussio n elucidate s ho w som e of th e statistica l factor s wil l b e incorporate di n EPA' s decisions

. b. Exposure assessment. A numbe r of th e propose dTie r

1 an d2 requirement s wil l provid e EP

A with informatio n o n populatio n exposure s t o fue l an d additiv e emissions

. Thi s informatio n include s (1 ) historica l arid/o r projecte d productio n volumes, (2 ) type s an d emissio n rate s o f

speciate demissio n components , (3 ) estimate durban , rural , and/o r microenvironmen t

exposure s obtaine dthroug h exposur e modelin g approaches , (4) evidenc e fo r bioconcentratio n fromenvironmenta l modelin g results , an d(5 ) possibl e literatur e searc h findings o n ambien t occupational , o r

epidemiologica l exposures
. A s mentione dabove , thi s informatio n wil l b e considere d qualitativel y b y EPA i n determinin g whethe r Tie r 3 testin g i s needed

. Significan t

publi c healt h concern s might sometime s b e reveale db y th e exposur e informatio n itself

. Thi s might b e th e case , for

example , if

ther e wer e a n anticipate dreleas e i n exces s of , say , 1,00 0 kg pe r yea r of individua l emissio n compound s (i n additio n f o "criteria " pollutants ) wit h know n toxicities , o r if th e anticipate dexposur e scenario s approache do r

exceede dcurren t estimate s o

f apparentl y saf

e level s of know n toxicants

. I n th e cas e of fuel s an dthei r associate dhigh-volum e bul k additives , EP

A wi U generall y assum e tha t huma n an denvironmenta l exposure s wi U b e o

f sufficient leve l an d exten t tha t significan t

observe dadvers e effect s woul dindicat e anee dfo r follow

u p i n Tie r 3

. Thi s exposur e assumptio n reflect s th e hig h productio n an d consumptio n of

thes e products , eithe r

a f th e presen t

time o r a s anticipate di n th e future

. Thus , decision s f

o promot e thes e product s t o Tie r

3 woul db e base do n th e degre e t o whic h additiona l testin g i s neede dt o clarif

y th e result s an d potentia l healt h effec t

implication s o f Tie r 1 an dTie r

Z data

. I t canno t b e assumed , o n th e othe r hand , tha t

fue l additive s use din relativel y lo w concentration s o r

produce di n relativel y lo w volume s woul dautomaticall y b e excuse dfromTie r

3

. Fo r thes e products , tes t result s indicativ e of

sever e healt h effect s and/o r

hig h exposur e level s i n circumscribe darea s might b e caus e fo

r escalatio n t o Tie r

3

. c. Health assessment. Genera l criteri a fo r evaluatin g th e potentia l publi c healt h effect s associate dwith fuel an dadditiv e emission s woul dinclud e (1 ) th e numbe r o f positiv e an dnegativ e outcome s relate dt o eac h endpoint , (2) tiie identificatio n o f

concentration-effec t relationships , (3 ) th e statistica l sensitivit y an dsignificanc e o f suc h studies , (4 ) th e severit y of th e observe d effect s (e.g. , whethe r

th e effect s woul d b e likel y t o lea df

o incapacitatin g o r irreversibl e conditions) , (5 ) th e numbe r of specie s involve di n th e reporte dtests , an d(6 ) th e consistenc y an dclarit y of apparen t mechanisms , targe t

organs , , an doutcomes

. Additiona l parameter s whic h woul dinfluenc e th e decisio n o n - whethe r t o requir e Tie r

3 woul dinclud e (1 ) findings of

environmenta l persistenc e o f th e emission s and/o r

th e abilit y of

th e emission s t o accumulat e i n livin g organisms , (2 ) th e natur e an damoun t o f know n toxi c agent s i n th e emission s stream , an d(3 ) th e observatio n of lesion s whic h specificall y implicat e inhalatio n a s a n importan t exposur e rout e for inducin g advers e healt h effects

. Thes e criteri awoul db e evaluate di n conjunctio n Wit

h th e result s of

th e exposur e assessmen t

t o determin e whethe r o r no t highe r leve l testin g wa s needed

. I n thi s decision , bot h th e biologica l an dstatistica l significanc e of th e result s o f

Tier s 1 an d2 woul db e take n int o account

. GeneraUy , escalatio n t o Tie r

3 woul db e considere d whe n remainin g uncertaintie s abou t th e significanc e of

observe doutcome s and / o r exposure s interfere dwith EPA' s abilit y t o mak e reasonable estimate s o f th e attendan t

publi c healt h risks. O n th e othe r hand , i f n o statisticall y significan t effect s wer e obtaine da t

an y exposur e leve l i n ascientificall y soun dTie r 2 stud y (o r existin g tes t

submitte di n lie u o f Tie r 2 testin g an dno t

contradicte db y othe r publishe dreports of

equa l o r greate r reliability) , an dif

othe r majo r source s o f

concer n di dno t

aris e (e.g. , toxi c effect s o f

structuraU y related compounds) , the n Tie r

3 testin g woul d no t b e require dfo

r th e endpoin t

i n question

. Thi s assume s tha t relevant , high-qualit y statistica l analysi s ha d bee n don e f

o permi t th e negativ e tes t result s f o b e properl y evaluate dan d interpreted

. Th e statistica l analyse s

. m....*.±m*MP.4 5

1321 0 Federa l Registe r/ Vol

. 57 , No

. 7 3 /

Wednesday

. Apri l 15

. 199 2 / Propose dRule s
recommende dfor

Tie r 2 i n a n earlie r discussion , includin g determinatio n o f Typ e I an dII error , shoul denabl e reasonabl e conclusion s t o b e draw n a s t o th e significanc e o

f negativ e findings

. Factor s t o b e token int o accoun t includ e th e toxicologica l natur e o f th e finding s an dth e exposur e level s use di n th e test

. Fo r example , i

f th e statistica l analyse s wer e applie dt o a"severe " endpoin t (e.g. , majo r

feta l abnormalities , majo r lun g pathology , etc ) an dth e exposur e i n questio n wa s moderate , the n 0. 1 woul d b e a n appropriat e Typ e II erro r level

. In contras t if ahig h concentratio n limi t tes t cause darelativel y mino r effec t (e.g. , asma

U chang e i n lun g lavag e protein) , ahighe r

Typ e II erro r

woul db e allowe d(e.g. , 0.2) , effectivel y increasin g th e chanc e o f

fals e negativ e conclusions

. Evaluation of

Tier 2 results. Th e specifi c outcome s whic h woul db e considere dpositiv e an dnegativ e result s fo r eac h propose dTie r

2 tes t ar e mentione dbriefl y i n th e previou s description s o

f Tie r 2 requirement s an d ar e define dan dinterprete dmor e precisel y i n th e propose dregulatory tex t Fo r example , thre e primar y studie s ar e include di n Tie r

2 whic h relat e t o carcinogenicit y an dmutagenicity : th e Ames , SCE , an dmicronucleu s assays
. A s compare dwith appropriat e controls , astatisticall y significan t

dose-relate d positiv e response i n an y on e o f thes e assay s coul db e caus e fo

r concern, a s woul dpositiv e outcome s for a t leas t on e concentratio n i n tw o o r

mor e o f thes e tests

. Suc h outcome s woul db e indicativ e o f

mutageni c risk; however , dependin g o n th e interna l an dhistorica l consistenc y of

thes e results an dthei r relationshi p t o projecte dexposures , furthe r testin g might

b e require dt o determin e th e significanc e of thi s mutageni c activit y i n huma n population s expose db y inhalation

. Thes e outcome s woul dals o indicat e tha t

th e emission s coul dinitiat e som e o

f th e mechanism s involve di n carcinogenesis

. However , th e productio n of

malignanc y i s amulti

ste p process , an dthes e result s woul d generaU y no t

i n themselve s b e sufficient t o determin e whethe r

th e emissions , wer e i n fac t

carcinogenic

. Thus , additiona l testing might

b e require d unde r Tie r 3 t o bette r

evaluat e th e associate dcance r

risks. In contrast , i

f n o statisticall y significan t result s wer e obtaine di n thes e thre e assay s an dn o conflictin g result s foun di n th e literatur e o r i n othe r Tie r 2 tests , the n Tie r

3 follow-up for

carcinogenicity / mutagencit y woul dno t

b e required

. T o tak e anothe r

example , determinatio n o

f th e nee dt o furthe r investigat e teratogenic risks woul dtak e int o accoun t

th e results o

f both th e inhalatio n developmenta l toxicit y stud y

an dth e reproductio n an dfertility assessmen t

o f Tie r 2

. I f negativ e result s we& e obtaine di n bot h o

f thes e test s (accordin g t o statisticall y soun d principles) , an di

f thes e result s wer e no t refute db y th e existin g literature , the n additiona l testin g woul dno t b e require d a t th e Tie r 3 leve l for

developmenta l o r reproductive effects

. Positiv e result s woul dinclud e adecreas e i n neonata l viabilit y relativ e t o tha t

i n contro l studies , asignifican t

chang e i n th e proportio n o

f viabl e mal e vs
. femal e fetuses o r offspring , th e presenc e of sof t tissu e o r skeleta l abnormalities , an da n increase drat e o

f embryoni c o r

feta l resorption

. Otiie r

positiv e outcome s of th e reproductio n an dfertility assessment , suc h a s abnorma l change s i n sper mstructur e o r

function , vagina l cytology , o r

reproductive orga n histopathology , woul db e indicativ e of hazard s t o th e adul t

reproductiv e systems

. Th e nee dfo

r additiona l evaluatio n unde r

Tie r 3 woul ddepen d o n ti e numbe r

of specie s fromwhic h positiv e result s wer e obtained , th e speeiScity , severity , an dconsistenc y of results , th e presenc e o r

absenc e of

a concentration-effec t

relationship , an d th e significanc e of

thes e outcome s i n vie w of projecte dexposur e scenarios

. Th e greate r

th e remaining uncertaint y regardin g th e risk

o f teratogeni c o r reproductiv e effect s afte r analysi s of suc h factors , th e highe r

woul db e th e likelihoo dtha t

Tie r 3 woul db e required. Similarly , consisten t

negativ e result s (accordin g t o statisticall y soun d principles ) obtaine di n othe r Tie r 2 tests , i n tiie absenc e of

significan t

relate d concern s raise di n ih e literature , woul d mak e Tie r

3 unnecessary
. O n th e othe r hand , i f advers e effect s ar e foun da t Tie r 2 and/o r reported fri th e literature , EP A woul ddetermin e i f

Tie r 3 foUow-u

p i s require db y attemptin g t o evaluat e th e nature , severity , an dsignificanc e of th e finding s i n ligh t

e f th e likel y exposures
. I f EU A determine s tha t

Tie r 3 testin g i s reqigre dt o resolv e th e remainin g uncertainties , th e Tie r

3 requirement s woul dreflec t

bot h positiv e an dnegativ e results. Fo r

example , if

th e results o f Tie r 2 wer e positiv e fo

r pulmonar y effeet s bu t

negativ e for

neurotoxicit y (accondw g t o criteri adiscusse dearlier) , an di f thes e results wer e consisten t with th e literature , onl y pulmonar y toxicit y woul db e alikel y candidat e fo r Tie r 3 foUow-u p testing

. Aeute health assessment

Unde r th e assumptio n tha t

emission s exposure s will generall y b e lo w an dthu s mor e likel y to caus e longer-termeffects , thi s propose drulemakin g doe s no t focu s o n acut e effects

. However , th e purpos e of CA A sectio n 21 1 i s t o protec t th e publi c health , whateve r

th e exposur e duration , an dpotentia l acut e effect s coul dals o b e aconsideratio n i n th e Tie r 3 decision

. EP A i s currentl y developin g a standardize dmetho do f

assessin g acut e noncance r

healt h effects , an dthi s metho dmight

b e usefu l fo

r evaluation s unde r thi s proposa l program
. Th e ne w metho dwil l estimat e level s of exposur e whic h ar e expecte dt o pos e n o o r minima l healt h risk

t o susceptibl e subpopulation s a s wel l a s level s posin g incrementall y highe r

risks. A draf

t of thi s metho di s expecte di n earl y fiscal yea r 1993

. After

aperio dfo

r commen t b y EPA' s Scientifi c Advisor y Boar d (SAB ) an dth e public , afinal draf t i s expecte di n fiscal yea r

1994

. Thus , th e ne w methodolog y ma y b e availabl e fo r us e i n atim e frame consisten t with th e need s of thi s program
. I

f acut e risk

mus t b e assesse dprio r

t o th e availabilit y of th e approve dmethodology , the n exper t judgmen t approache s coul db e applied

. EP A seek s commen t

o n thes e possibl e method s fo

r takin g acut e healt h effect s int o accoun t

i n th e determinatio n o

f Tie r 3 requirements

. Inhalation reference concentrations. Anothe r standardize dmethodolog y unde r developmen t

b y EP A might als o b e applicabl e t o decision s o n whethe r t o requir e Tie r

3

. Thi s process , th e inhalatio n referenc e concentratio n (RfC) methodology , i s currentl y i n draf t form

. Afte r incorporatio n of

revisions base d o n SA B an dpubli c comments , th e report i s expecte dt o b e finalizedi n fiscal yea r 1992

. Fro mtime t o time, EPA.wil l b e revisin g thi s methodolog y t o reflect advance s i n th e stat e of

th e art

. Whil e th e presen t

Rf C methodolog y recognize s subchroni c data , i t focuse s o n chroni c data , sinc e th e Rf C i s intende dt o addres s healt h risk du e t o lifetim e exposures
. Specifically , a chroni c Rf

C i s a n estimat e of

adail y inhalatio n exposur e t o human s (includin g sensitiv e subpopulations ) though t t o b e withou t

appreciabl e noncance r

risk ove r a70-yea r lifetime

. Th e minimu mdat abas e requiredt o develo p achroni c Rf

C include s a t

leas t a90-day inhalatio n exposur e tha t thoroughl y addresse s .th e potentia l for respirator y trac t

toxicit y an destablishe s alowest-observed-adverse-effec t leve l (LOAEL ) an dano-observed-adverse

effec t leve l (NOAEL) for

a"critica l effect. " Thi s i s asensitiv e endpoin t tha t plausibl y protect s agains t othe r les s sensitiv e effects

. Th e NOAE L an d LOAE L ar e adjuste dwit h dosimetri c extrapolatio n factor s t o deriv e ahuma n equivalen t

NOAE L o r LOAE L Variou s uncertaint y factor s ar e the n applie dt o operationall y deriv e th e RfC

. A draf tmethodolog y an dminima l verificatio n

criteri afor

th e Rf C ar e availabl e i n "Interi mMethod s fo

r Developmen t

o f Inhalatio n Referenc e Doses , U.S

. EPA , 198 9 (EPA/600/8-88/066F)

. Assumin g th e RfC s applicabl e t o fuel an dfuel additiv e emission s coul db e derive dfromTier s 1 an d2 information , the y coul dpotentiall y b e use dt o determin e testin g needs

. Fo r example , if exposure s wer e i n th e vicinit y o f o r significantl y abov e th e RfC , th e emission s woul db e considere df o hav e toxi c potentia l an dTie r

3 woul d probabl y b e invoked

. I

f exposure s wer e substantiall y lowe r

tha n th e RfC , publi c healt h concern s woul dgenerall y b e allayed

. However , th e Rf C methodolog y woul dno t

remove th e nee dt o temper thes e conclusion s with exper t scientifi c judgment

. Fo r

example , if

th e advers e healt h effect s appeare dsever e o r exhibite dth e potentia l t o progres s significantl y wit h duratio n of exposure , an dif th e potentiall y expose d populatio n wer e large , the n signfican t concer n might

persis t eve n i f preliminar y estimate s of

th e exposur e level s wer e lo w relativ e t o th e RfC

. Comment s ar e requeste dconcernin g th e possibl e applicatio n o f

th e Rf C methodolog y t o Tie r

3 decision-makin g i n th e propose dprogram
. 3

. Potentia l Tie r

3 Testin g Requirement s T o b e mos t

cost-effective , Tie r

3 testin g woul db e designe dt o specificall y addres s dat agap s regarding th e endpoint s o f

concern
. Thus , Tie r

3 requirements coul dpotentiall y includ e furthe r emissio n characterizatio n procedures , perhap s involvin g i additiona l vehicles , t o identif y an d quantif y harmfu l emissio n product s wit h greate r precision

. Higher-orde r

modelin g calculation s o r

exposur e fieldstudie s coul db e requiredt o resolve uncertaintie s i n th e Tie r

1 emission s exposur e information

. Healt h effect s testin g requirements woul db e aime da t providin g sufficient

informatio n t o mak e soun dconclusion s abou t

th e degre e of healt h risk. I

f mor e tha n on e endpoin t wer e of concern , EP

A woul dattemp t

t o reduc e testin g cost s b y permittin g combine dprotocol s and/o r inhalatio n exposure s insofar

a s possible

. Emissio n ' characterizatio n or.healt h effect s testin g usin g emission s generate dfrom miscalibrate dvehicle s o r unde r othe r non-FT P condition s might sometime s b e included

. Fo r aquantitativ e risk

assessment , healt h effect s tes t

exposure s woul db e chose n t o permi t

th e determinatio n of

a NOAE L an dLOAE L Whil e Tier s 1 and / o r 2 ma y provid e som e of

thi s information , Tie r

3 woul dtypicall y requir e NOAE

L o r LOAE L determination s for longe r duratio n exposure s o r

additiona l endpoints

. I

f chroni c inhalatio n studie s ar e required , the y woul dgenerall y b e precede db y subchroni c range-findin g studies

. Thes e woul davoi dth e possibilit y of designin g achroni c inhalatio n tes t

wit h exposur e level s s o hig h tha t

excessiv e mortalit y occur s o r s o lo w tha t

aLOAE L i s no t identified

. Dependin g o n th e endpoint s unde r evaluation , consideratio n woul d als o b e give n t o includin g amid

duratio n examinatio n i n th e cas e o f chroni c inhalatio n tests

. A mid-duratio n evaluatio n woul db e usefu l fo r affirmin g th e adequac y of

exposur e level s and , i n som e cases , might

enabl e interi mris k conclusion s t o b e draw n whic h woul d avoi dth e nee dfo

r furthe r examination

. Inhalatio n studie s woul dgenerall y mak e us e of rodent species , bu t

highe r orde r mammal s might

occasionall y b e required

. Whil e Tie r

3 testin g requirement s woul db e targete dt o critica l area s of concern , EP

A woul dals o exercis e it s judgmen t t o avoi dth e fals e econom y o f establishin g overl y narro w requirements. Jus t

a s requirement s for to o man y assay s woul db e wastefu l of resources, requirements for to o fe w assay s migh t

resul t i n inconclusiv e findings, creatin g need s fo r stil l furthe r testin g a t greate r tota l expens e tha n woul dhav e bee n necessar y a t th e start

. Similarly , EPA woul dconside r th e valu e o f includin g secondar y evaluation s a s usefu l an dlow-cos t

adjunct s t o test s alread y required

. Fo r

example , i

f th e histopatholog y o

f aspecifie dtarge t orga n wer e th e primar y examinatio n require da t

th e conclusio n of

a n inhalatio n exposure , othe r organ s coul d b e weighe dan dsave di n storag e for a limite dtim e period , a t

lo w incrementa l expense
. I

f indicated , thes e othe r

organ s woul dthe n b e availabl e fo r subsequen t examination , avoidin g th e possibl e nee d f o repeat th e chroni c inhalatio n procedure s t o asses s th e effect s o n thes e othe r organs
. Becaus e th e specifi c healt h testin g requirement s whic h woul db e impose d i n Tie r 3 woul db e tailore dt o individua l circumstances , precis e tes t guideline s canno t b e provide di n advance

. However , som e o f

th e likel y testin g scenario s whic h might

b e require di n Tie r 3 ar e cite dbelow

. Wher e possible , existin g TSC A guideline s fo r thes e test s ar e referenced

. I t

shoul db e recognized , however , tha t

suc h guideline s might nee dt o b e revisedt o accommodat e emissio n inhalatio n requirement s and / o r t o evaluat e certai n structure s o r function s whic h th e curren t guideline s d o no t adequatel y address

. Stud y parameter s whic h might

require modificatio n includ e exposur e route s

an dconcentrations , specie s selection , numbe r of anima l subjects , examinatio n procedure s an dfrequencies , an d analyti c requirements

. Furthermore , interi madvance s i n th e underlyin g scienc e an dtestin g technolog y ma y provid e superio r

approache s whic h coul db e availabl e for

us e b y th e tim e Tie r 3 requirement s woul db e implemented

. Tie r 3 follow-u p fo r

mutagenicit y an d carcinogenicit y concern s raise di n Tier s 1 an d2 woul dofte n includ e acance r bioassa y of

chroni c duratio n (e.g. , 4 0 CF R798.330 0 o r 798.3320)

. However , thi s woul dgenerall y b e precede db y short

ter mstudie s t o investigat e th e mechanism s involve dand , i n som e cases , thes e shorte r

test s might

b e sufficien t t o alla y concern s o r

clarif y th e natur e o f th e risks. Amon g thes e possibilitie s i s amutagenicit y battery , whic h might

includ e abiochemica l specifi c locu s test , bacteria l DN A damag e o r

repai r tests , an dheritabl e translocatio n tes t

(4 0 CF R798.5195 , 798.5500

. an d798.5955)

. Newe r procedures , suc h a s cel l transformation , DN A adducts , an dgen e amplification , woul dals o b e considered

. I n addition , , physiologicaUy-base dpharmacokineti c (PBPK ) o r metaboli c studie s (e.g. , 4 0 CF R 798.7100) migh t

b e required. Tie r 3 evaluatio n o f

reproductiv e an d developmenta l toxicit y woul dgenerall y involv e tw o generatio n breedin g studie s (4 0 CF R798.4700) and/o r

reproductive assay s b y continuou s breedin g (RACB ) 2S

. Eac h of

thes e approache s entail s approximatel y 9-1 2 month s o f exposure
. Additiona l evaluatio n for neurotoxicit y migh t

includ e metaboli c analyse s (40 CF

R798.7100) , subchroni c neurotoxicit y (includin g histopathology ) test s (4 0 CF

R798.6400) , and/o r

one
- t o two-yea r chroni c inhalatio n test s (e.g. , 4 0 CF R798.3260)

. Suc h studie s migh t involv e neurobehavioral , neurochemical , pharmacokinetic , and/o r histopathologica l assessments

. Becaus e fetuse s an dinfant s ma y b e particularl y sensitiv e t o neurotoxicants , specia l studie s involvin g in-uter o an dneonata l exposure s might

b e indicated

. Th e foUow-u

p requiredfo r

pulmonar y toxicit y concern s woul dfrequently involv e subchroni c and/o r chroni c inhalatio n studie s (40 CF R798.245 0 an d 798.3260) , emphasizin g histopatholog y o f th e respirator y tract

. I

f indicated , pulmonar y functio n measurements , hos t

0 0 A protocol develope d b y th e National Toxicology Progra

m o f the Nationa

l Institut e o f Environmenta

l Healt h Science s i s availabl e in th e public docket .P.4 7

1321 2 Federa l Registe r/ Vol

. 57 , No

. 7 3 /

Wednesday , Apri l 15 , 199 2 / Propose dRule s
defens e assays , immunotoxicity tests , an denzym e assay s o

f lavag e cell s an d fluid s might

b e require di n conjunctio n with thes e exposures
. I

f both chroni c toxicity an dcarcinogenesi s wer e o f cpncern, the n acombine dprotoco l (4 0 CF R798.3320

) woul db e i n order

. Tie r 3 testin g t o follo w u p o n Tie r 1 finding s woul ddepen do n th e specifi c identifie dconcerns
. EP

A anticipate s tha t suc h concerns , identifie db y previou s scientifi c studie s i n th e literatur e o r

b y th e occurrenc e of

know n toxic chemical s i n th e emissions , woul d mos t ofte n pertai n t o potentia l hepatic , renal , o r endocrin e toxicity , bu t

effect s o n othe r orga n system s o r

physiologi c processe s ar e als o possible

. Potentia l testin g might

includ e metabolic , subchroni c exposure , and/o r chroni c exposur e studie s (4

0 CF R798.7100 , 798.2450 , and/o r

798.3260)

. bu t specialize dfunctional , immunologic , an d enzym e studie s might

als o b e required

. A s previousl y mentioned

. Tie r 3 requirement s coul dals o includ e additiona l wor

k t o improv e th e exposur e estimate s submitte di n complianc e with Tie r 1

. Th e nee dfo

r additiona l exposur e dat awoul ddepen di n par t o n th e limitation s of

th e Tie r 1 estimates , an d i n par t o n th e natur e o

f th e associate d healt h effect s information

. Tha t is , highl y precis e an daccurat e exposur e informatio n woul dno t

b e cos t effectiv e if th e healt h assessmen t

wer e base do n limite dand/o r

uncertai n results, an d vic e versa
. Th e approac h whic h EP

A plan s t o us e i n determinin g th e potentia l nee dfo r greate r precisio n an daccurac y i n th e exposur e informatio n i s t o conside r th e slop e o f th e toxic response. I

f th e slop e i s stee p withi n th e rang e o f potentia l huma n exposures , the n asmal l chang e i n exposur e i s likel y t o hav e amajo r impac t o n th e eventua l ris k

assessment

. Greate r precisio n woul dthu s b e require di n th e exposur e calculation

. I f advers e healt h effect s appea r likel y withi n th e projectedrang e of exposures , improve destimate s migh t als o b e neede dt o determin e tiie condition s an d location s unde r

whic h thes e exposure s might occu r a s wel l a s th e siz e o

f th e potentiall y affecte dpopulations

. O n th e othe r hand , i f onl y mino r

healt h effect s occu r a t level s wel l abov e ambien t concentration s an donl y arelatively smal l numbe r

o f peopl e ar e likel y t o b e exposed , the n additiona l refinement s o f th e exposur e calculation s woul dno t b e warranted

. Tie r 3 exposur e assessmen t

coul d includ e physica l monitorin g studie s o r th e applicatio n o

f mor e sophisticate d modelin g techniques , som e of whic h ar e describe di n Sectio n VIJ3.2

. However , th e precis e natur e of

thes e studie s woul db e strongl y influence db y interi m

advance s tha t

ar e expecte di n tiie growin g scienc e o

f exposur e assessment

. Th e genera l topic o f gasolin e exposur e i s receiving increase d attentio n b y th e scientifi c community a s atopi c fo r research , i n recognition o f th e limite dknowledg e bas e currentl y availabl e fo

r determinin g th e risks fro m mobil e sourc e emission s an dfromth e us e o f moto r vehicl e fuels. 2 8 Thus , ne w informatio n an dne w scientifi c methodologie s fo

r monitorin g an d estimatin g populatio n exposure s ar e expecte dt o emerg e i n atime frame whic h wil l b e usefu l fo

r guidin g th e type s o f exposur e assessment s whic h might b e require da t

th e Tie r 3 level

. EP A requests comment s o n th e possibl e scenario s an dtes t guideline s outline dabove , an dsolicit s suggestions o n othe r healt h effec t

an dexposur e studie s whic h shoul db e considered

. A n alternativ e approac h fo

r determinin g Tie r 3 testin g requirements woul dpermi t di e responsibl e manufacturer s t o propos e testin g scenario s whic h woul d addres s th e area s o

f concer n identifie d b y EP A a s requirin g Tie r

3 follow-u p evaluation

. Suc h proposal s woul db e subjec t t o revie w an dapprova l b y EP A scientist s prio r

t o thei r implementatio n b y th e manufacture r

i n complianc e wit h Tie r 3

. Comment s ar e requeste dabou t thi s alternativ e approach

. VII

. Reportin g Requirement s Th e material s t o b e submitte dt o EP A followin g completio n of

al l Tie r 1 an d Tie r 2 requirements ar e divide dint o thre e majo r

categories : Basi c registratio n data , asummary report , an d appendices

. Producer s wh o mus t conduc t additiona l testin g unde r

Tie r 3 wil l b e require dt o submi t afinal repor t whe n th e designate dTie r 3 testin g i s complete

. Th e natur e o

f th e informatio n t o b e include di n eac h reporting categor y i s describe dbelow

. A. Basic Registration Data Th e informatio n mandate db y existin g regulation s unde r

sectio n 211(b)(1 ) mus t b e submitte d(o r

resubmitted ) individuall y for

eac h produc t

bein g registered , usin g EP

A form s whic h ar e i n effec t a t th e tim e o

f th e submittal

. Thi s requiremen t

pertain s t o al l previousl y registere dfuel s an dadditives , includin g relabele dproducts , a s wel l a s thos e fo r whic h first-time registratio n i s sought

. However , i

f th e basi c registratio n dat a previousl y submitte dfo

r a n existin g fue

l o r additiv e i s accurat e an dcomplete , the n astatemen t

assertin g tha t

thi s i s s o wil l suffic e i n lieu o

f th e submitta l o

f

* * Journal o f

Exposur e Analysi s an d Environmenta l Epidemiology
. January-March , 1992
. duplicat e information

. A findin g b y EP A tha t thi s informatio n i s no t

i n fact , accurat e an dcomplet e a s claime dwil l resul t i n th e report

bein g considere d inadequate

. Th e basi c informatio n currentl y require dfo

r fuel an dadditiv e registratio n include s produc t an d manufacture r

identification , concentratio n an dpurpose-in-use , an d specifi c compositiona l data

. I n additio n t o thes e items , informatio n o n th e productio n volum e of

eac h produc t

wil l b e required. I

f tiie produce r

ha s participate di n grou p effort s t o satisf y Tie r 1 an dTie r

2 requirement s fo

r th e product , the n identifyin g informatio n for th e grou p mus t

als o b e provided

. Similarly , i

f th e produce r

i s relying o n anothe r manufacturer' s (o r

group's ) previou s registration material s i n complianc e with th e testin g requirement s fo

r ane w product , the n th e othe r manufacture r

an dproduc t

(o r group ) mus t

b e identified

. In addition , th e produce r

mus t certif y an dprovid e evidenc e tha t

th e first manufacture r

ha s bee n notified

. B. Summary Report Thi s documen t

wil l provid e atex t summary o

f th e evaluatio n procedures , results , an dconclusion s pertainin g t o Tier s 1 an d2

. A cove r

pag e shoul db e included , identifyin g th e subjec t product , th e manufacturer' s nam e an daddress , an dadesignate dcontac t perso n an d phon e number

. Fo r

grou p submissions , al l product s an dmanufacturer s t o whic h th e repor t pertain s mus t

b e named , an d acontac t person , address , an dphon e numbe r fo r th e grou p mus t

b e identified

. I f agrou p submissio n ha s bee n prepare d unde r th e aegi s o

f atrad e o r

othe r umbrell aorganization , thi s organizatio n mus t als o b e identified

. Th e bod y o f th e summary repor t

shoul db e divide dint o th e followin g sections : 1

. Executiv e Summary Thi s shoul dconsis t

o f abrie f descriptio n o

f th e genera l result s an d conclusion s o

f Tie r 1 an dTie r

2 activities , emphasizin g informatio n an d tes t dat awhic h provid e evidenc e fo r potentia l advers e healt h and/o r welfar e effects

. 2

. Tie r 1 Report Thi s sectio n o

f th e summary repor t

i s intende dt o provid e a n overvie w o f tiie informatio n provide db y Tie r 1

. Detaile d procedura l descriptions , tables , an d othe r output s ar e t o b e include din th e appendices

. Literature search. Th e searc h method s shoul db e described , includin g th e identit y o f dat abases , searc h terms , an dP.48

.

tim e period s accessed

. An y in-hous e and/o r othe r unpublishe dstudie s include di n th e literatur e searc h shoul d als o b e describe dbriefly

. Th e result s an dconclusion s of

th e literatur e searc h wit h respec t

f o potentia l healt h an d welfar e effect s o f

th e subjec t

fuels / additive s shoul db e summarized

. I f tes t documentatio n provide db y th e literatur e searc h ha s bee n use dt o satisf y som e o r

a U of th e othe r program requirements , th e relevant studie s shoul db e discusse dan dtiieir adequac y f o fulfil l th e specifi c purpose s o

f th e associate dprogra mrequirements shoul d b e justified

. Finally , th e person(s ) o r contractor s conductin g th e searc h ar e t o b e identified

. Emisaion generation and characterization. Thi s sectio n o f th e summar y repor t

shoul didentif

y th e vehicl e selecte dan ddescrib e th e procedure s followe di n vehicl e preparatio n an dmaintenanc e an di n th e generation , storage , an dprocessin g of emission s fo r

testing

. A descriptio n o

f th e analyti c method s use dt o characteriz e th e fuel/additiv e emission s product s shoul dals o b e provided

. Problem s encountere di n generatin g and/o r characterizin g th e emission s shoul db e discussed , includin g attempt s f o resolve th e problem s an dthei r potentia l effect s o n testin g outcomes

. Th e laboratorie s performin g thes e procedure s shoul db e identified

. Modeling. Th e underlyin g principles , functions , an dlimitation s of th e chose n modelin g o r

othe r analyti c method s shoul db e explained , an da.summary of result s an dconclusion s provided

. 3

. Tie r 2 Report Fo r eac h study , th e objectives , principles , an dgenera l procedure s shoul db e outline dan dth e findings an d conclusion s summarized

. Discussio n shoul db e include dregardin g problem s encountere ddurin g th e performanc e o f th e test s an dth e method s use dt o resolv e them

. Thi s discussio n shoul d includ e th e impac t

whic h suc h problem s ma y hav e ha do n th e stud y outcomes

. 4

. Conclusion s Furthe r testin g need s shoul db e identifie do r

els e adiscussio n shoul db e provide dexplainin g wh y th e result s o f Tier s 1 an d2 shoul dno t

trigge r Tie r 3 testin g requirements. C. Appendices Detaile dinformatio n i n support o f th e genera l discussion s containe di n th e summary repor t

ar e t o b e submitte da s appendice s t o tha t

report. I n regar dt o th e literatur e search , th e appendice s wi U contai n (1 ) summar y fables , usin g th e forma t for Tabl e I V suggeste dwithi n th e draf t petitio n proces s guideline s associate dwit h th e ai r

toxic s progra m (availabl e i n Centra l Docke t Sectio n A

130 , EP A Docke t No

. A-SO-48) , (2 ) a complet e printe dcop y o

f referenc e list s an dassociate dabstract s obtaine dfrom databas e searches , (3 ) complet e documentatio n of

in-hous e studie s an d othe r unpublishe dinformatio n sources , an d(4 ) complet e documentatio n (e.g. , copie s of journa l articles ) o f

previou s studie s whic h ar e bein g cite di n satisfactio n o f

emissio n characterizatio n and/o r Tie r 2 tes t requirements.

' Appendice s f

o th e emissio n characterizatio n sectio n wil l contai n detaile dprotocols , copie s o f al l relevant laborator y reports , alis t

of al l speciate d emissio n product s an dthei r emissio n rates , an ddocumentatio n o f calibration / verificatio n procedures

. Fo r th e sectio n o n modelin g methods , a n appendi x shoul db e provide dfo

r detaile d calculation s an dresults

. A n appendi x i s als o require dfor eac h o f th e test s conducte di n complianc e wit h Tie r 2 requirements. Thes e appendice s shoul dcontai n th e ful l detaile dstud y protocol , complet e laborator y report

statistica l analysi s of th e findings , an dscientifi c conclusions

. Thes e material s shoul dconformt o th e reporting requirement s o f th e individua l stud y guideline s a s we

U a s th e genera l standards.fo r

recordkeepin g an d reporting specifie di n 4 0 CF Rpar t 792 , subpar t J

. A fina l appendi x shoul db e provided , containin g laborator y certification s an dassociate dpersonne l credentials

. D. Tier 3 Report Report s for

additiona l test s required unde r th e provision s of

Tie r 3 shoul d includ e acove r

pag e with identifyin g informatio n a s describe dabov e fo r th e Tie r 1 an d2 summar y report

. Th e report shoul dbegi n wit h discussio n of th e concern s arisin g unde r

th e previou s tiers whic h le dt o th e Tie r

3 requirements, th e specifi c objective s o f

th e additiona l studies , an dasummar y o f pertinen t result s an dconclusions

. Thi s summar y discussio n shoul db e supporte dwith appendice s containin g th e kind s of documentatio n discusse dabov e wit h respec t t o Tie r 2 : Fu U protocols , la b reports , statistica l analyses , discussio n o f problem s an dfindings , an d conclusions

. Th e laborator y conductin g th e requiredtest s mus t

b e identified , an drelevant

certification s an d personne l credential s provided

. VIM

. Specia l Provision s A. Exemption for

Relabeled

Products A company' s produc t

i s registereda s "relabeled " i

f i t i s simpl y arepackaged an drebrande dversio n o f aformulatio n whic h i s als o registeredb y th e origina l manufacturer

. A s previousl y discussed , requirin g companie s whic h sel l relabele dproduct s t o conduc t th e healt h an dwelfar e effect s assessment s propose di n today' s rulemakin g woul d clearl y duplicat e th e effort s o f th e origina l manufacturer

. Thus , unde r th e authorit y of

sectio n 211(e)(3)(C) , whic h provide s tha

f th e Administrato r

ma y exemp t fromth e rul e an y fuel o r fuel additiv e upo n afindin g thaf an y testin g of tha f fuel o r fuel additiv e woul db e duplicativ e o

f adquat e existin g testing , relabele dproduct s wi

U b e exemp t from th e evaluatio n an dtestin g requirement s of th e registratio n program
. Fo r relabele dproducts , onl y basi c registration informatio n will b e required, a s describe dabov e i n sectio n VILA

. Of course , thi s presume s tha t th e registration requirements propose di n thi s NPR M woul db e satisfiedfor

th e origina l produc t

b y th e origina l manufacturer

. Amon g th e tota l of

1,16 0 manufacturer s wit h on e o r mor e registeredfuel additive s a s o f mid-1990 , ove r hal f (604) registeredonl y relabele d additives , an dwill therefor e no t b e requiredto compl y wit h th e healt h an d welfar e effect s assessmen t provision s o f th e registration program
. Relabele d additive s accoun t

for approximatel y 3 0 percen t of al l additiv e product s currentl y registered. B. Applicability of

Evaporative Emission Testing A s discusse dfully i n sectio n IIIC , requirements fo

r th e chemica l characterizatio n an dtoxicologi c testin g of evaporativ e emission s ar e propose d t o appl y onl y t o thos e fuel s an d additive s for

whic h vaporizatio n i s expecte dt o b e significan t Fuel s whic h ar e supplie db y wa y of

seale d containmen t

an dengin e deliver y system s woul dthu s b e exemp t from evaporativ e emissio n requirements, a s woul dliqui dfuel s with RVP les s tha n 2. 0 psi

. Methane , propane , an ddiese l fuel s woul db e exemp t

fromevaporativ e emission s testin g unde r

thi s guideline

. Th e propose dcriteri afo

r determinin g th e applicabilit y o f

evaporativ e emissio n testin g requirement s t o additive s ar e base do n (1 ) th e chang e i n RVP of th e appropriat e additive/bas e fuel mixtur e relativ e t o th e RV P o

f th e bas e fuel

. alone , an d(2

) th e partia l pressur e o

f th e additiv e i n th e additive/bas e fuel mixture

. I f th e presenc e of

th e additiv e doe s no t increas e th e RV P o f

th e bas e fuel b y a t leas t 0. 1 psi , an di

f th e partia l pressur e of

th e additiv e i n th e additive / fuel mixtur e i n th e vapo r phas e a t 1C 0P.4 9



### 1321 4 Federa

l Registe r / Vol

. 57 , No

. 7 3 /

Wednesday , Apri l 15 , 1992' / Propose dRide s degree s Fahrenhei t

an datmospheri c pressur e i s les s tha n 0. 1 psi , the n evaporativ e emissio n testin g woul dno t nee dt o b e performed

. C. Small Business Provisions Sectio n 211(e ) grant s EP

A discretionar y authorit y t o provid e progra mexemptions , deferments , o r modification s for

smal l businesses

. However , i n developin g th e propose d registratio n program , EP

A ha s carefull y balance dth e desir e for

rigorous scientifi c evaluatio n with consideratio n for th e associate dcosts , an dha s include danumbe r

o f provision s designe dt o decreas e th e cos t burden s t o a U manufacturers

. Thes e genera l cost

reductio n provision s include : (1 ) Th e tiere dprogra mstructur e whic h impose s rigorou s testin g requirements onl y whe n neede dt o furthe r

explicat e significan t identifie dconcerns , (2

) th e opportunit y t o shar e progra mcost s an dburden s wit h othe r

manufacturers , (3 ) th e abilit y t o rel y o n existin g adequat e informatio n for complianc e wit h testin g requirements , (4) th e exemptio n fo r relabeledproducts , an d(5 ) th e genera l relianc e o n existin g regulator y program s fo r evaluatin g potentia l emissio n contro l syste meffects

. I n consideratio n of thes e provisions , EP

A i s no t initiall y proposin g t o implemen t

th e authorit y t o mak e specia l allowance s fo

r smal l businesses

. EPA' s economi c analyse s indicat e tha t th e financial impac t

o f th e propose d progra mo n mos t

fue l an dfuel additiv e producer s woul db e relativel y modes t Th e media n cos t

pe r produce r i s estimate dt o b e abou t

$2,00 0 fo r complianc e wit h Tier s 1 an d2

. Furthermore , th e cost s fo r abou t 8 5 percen t o f smal l fuel companie s an d7 0 percen t o f smal l additiv e companie s (a s define db y th e Sma

U Busines s Administration ) woul db e les s tha n $10,000

. Nevertheless , th e estimate d tota l cost s pe r

manufacture r

var y widely , fromabou t

$500 t o ove r

$ 2 million , dependin g o n eac h manufacturer' s numbe r

an dtyp e of product s an dopportunitie s fo r cost

sharin g with manufacturer s o f similar products

. Thus , a s on e might expect , th e financia l impac t

of th e propose d progra mcoul db e significan t for som e smal l companies

. A s discusse dfurthe r

i n sectio n XIV , below , aRegulatory FlexibiUt y Analysi s conducte db y EP

A indicate s tha t

sma U fuel producer s woul dno t b e jeopardize d b y th e propose drule , bu t tha t nearl y si x percen t of sma U additiv e manufacturer s (abou t 1. 5 percen t

o f al l fuel/additiv e manufacturers ) might

experienc e financial distress

. However , siz e alon e doe s no t predic t whic h additiv e manufacturer s woul db e adversel y affected , an dEP A ha s no t ye t bee n abl e t o identif y wha t i f any , commo n factor s plac e certai n smal l companie s a t risk. Furthe r analysi s i s expecte dt o clarif y thes e factor s and , i

f appropriate , EP

A ma y elec t t o implemen t

specia l provision s fo

r suc h companie s i n th e final rule

. Variou s alternativ e provision s ar e unde r consideratio n fo

r thi s purpose
. First , th e vulnerabl e companie s coul db e excuse dfromon e o r

mor e of th e program' s requirements. Fo r example , the y coul db e excuse dfromal l Tie r 2 biologica l testin g o r

coul db e require dt o conduc t onl y thos e Tie r

2 test s whic h addres s th e endpoint s mandate db y statut e (carcinogenicity , mutagenicity , an dteratogenicity)

. Anothe r alternativ e woul db e t o require onl y th e Tie r 1 literatur e searc h fo r

suc h companies

. T o ensur e tha t

n o smal l additiv e companie s woul db e financiaUy stresse db y th e regulations , complet e progra m exemption s might

b e necessary
. However , th e potentia l healt h an d environmenta l effect s associate dwit h a n additiv e produc t

ar e generall y no t relatedt o th e siz e o f

it s producer , an d EP A doe s no t

favo r thi s alternative

. O n th e othe r hand , becaus e risk

i s partl y a functio n o f

exposure , an dpotentia l exposur e t o a n additive' s emission s i s relatedt o th e volum e produce dan d sold , appropriat e measure s of volum e i n conjunctio n wit h othe r

relevant financial parameter s ma y b e reasonabl e t o conside r

i n determinin g possibl e smal l busines s allowances

. Publi c commen t

i s requeste d concernin g thes e smal l busines s issue s an dalternativ e idea s for

possibl e smal l busines s allowance s o r

exemptions

. D. Possible Exemption for "De Minimis" Factors EP A i s considerin g th e creatio n o f progra mexemption s fo

r certai n fuel additive s whic h ar e expecte dt o hav e onl y a"de minimis"impact o n th e compositio n an dbiologica l effect s o f moto r vehicl e emissions

. Thes e exemption s ar e contemplate dunde r tw o set s o f circumstances , describe dbelow

. EP A request s commen t

o n eac h of

thes e possibl e exemptions

. Th e first exemptio n unde r consideratio n woul drelate t o additive s whic h ar e recommendedfor us e a t les s tha n 2,50 0 pp mmaximu mconcentratio n i n fue l an dwhic h fal l int o th e "baselin e conventional " categorie s describe d abov e i n sectio n IV

. Becaus e th e elementa l compositio n o

f thes e additive s i s th e sam e a s thei r associate d bas e fuels , an dbecaus e som e degre e o f emission s variabilit y i s inevitable , i t ma y b e extremel y difficult t o distinguis h th e emissio n product s o r

th e emissions

base dbiologica l effect s o f thes e additive s (a s mixe di n bas e fuel ) fro m th e emissio n product s o r

effect s of th e bas e fue l alone

. Thes e factor s ar e reflecte di n th e propose dgroupin g scheme , i n whic h baselin e conventiona l additive s an dfuel s ar e groupe dtogethe r an dshar e th e sam e representatives. However , a n argumen t

ca n b e mad e tha t tes t requirement s fo

r thes e additive s J woul db e duplicativ e o f

th e requirements fo

r th e relatedfuels , an d tha t atestin g exemptio n for

th e additive s might

b e justifiabl e unde r sectio n 211(e)(3)

. If th e exemptio n fo r

baselin e conventiona l additive s wer e pu t int o effect , the n th e secon dexemptio n possibilit y woul darise

. Thi s potentia l exemptio n woul dappl y t o thos e additive s i n th e "atypical " formulatio n classe s (se e sectio n TV) whic h ha dsuc h smal l concentration s of

th e atypica l i component s tha t

thei r emissio n product s coul db e judge dt o b e o f

negligibl e toxicologi c significance

. Th e specifi c concentratio n criterio n for thi s exemptio n coul db e establishe db y assumin g tha t

th e toxicit y of

th e atypica l componen t

wa s simila r

t o tha t o f a know n toxic agen t

(e.g. , lea do r benzene ) an dthe n estimatin g th e maximu mconcentratio n of suc h a toxican t whic h woul dresul t

i n a n insignifican t

exposur e risk. Comment s ar e solicite di n regardt o possibl e exemption s unde r thes e "de Miinlmis" circumstances. Suggestion s for Vthe^pecifi c concentratio n whic h coul d b e use d«s-th e threshol dfor grantin g 'atypicrfedditiv e exemptions , an dth e underlyla g rational e fo

r selectin g tha t threshold , ar e als o welcome

. E. Possible Temporary Exemption for Experimental

Fuels and

Fuel Additives A s par t o f th e Augus t

7,199 0 ANPR

M for thi s action , EPA requeste dcommen t o n whethe r

specia l provision s shoul db e include dfo r

lo w volum e fuel s an d additives

. I n general , commenter s o n th e ANPR M di dno t suppor t alon g termo r permanen t

exemptio n for

lo w productio n volum e fuels/additive s du e t o equit y an dpubli c healt h considerations

. Nevertheless , EP

A believe s that , unde r certai n circumstances , a temporar y exemptio n fo

r lo w productio n volume , experimenta l fuel s an d additive s ma y b e appropriate , simila r t o th e provision s fo

r experimenta l chemical s unde r

th e Toxi c Substance s Contro l Ac t

(TSCA)

. Authorit y for

thi s possibl e provisio n woul db e base do n CA A sectio n 211(e)(3)(A) , whic h permit s EP A t o exemp t

defer , o r modif y th e progra mrequirements fo

r an y smal lP.5 0

Federa l Registe r

X LY. 0 )-. ?? • No

- 7 ? /

Wednesday , Apri l 15^/199 2 /

. Propose dRule s 1321 5
business , with "smal l business " t o b e define dwithi n th e regulations

. Give n tha t complianc e cost s fo

r thi s propose d progra mcoul dexcee damUlion dollar s fo r ne w o r uniqu e fuel s an dadditives , th e propose dtestin g an devaluatio n requirement s coul dpos e asubstantia l barrie r t o innovatio n an ddevelopmen t a t atim e whe n bot h environmenta l an d energ y concern s ar e generatin g significan t

pubU c an dprivat e secto r interes t an dactivit y i n thi s area
. Thus , EP A request s comment s o n th e possibilit y of

providin g atemporar y progra mexemptio n o r

defermen t

for experimenta l fuel s an dadditives

. Eligibilit y fo r thi s possibl e exemptio n woul db e limite dt o ne w products , i.e. , thos e whic h wer e no t

registereda s of th e effectiv e dat e o

f th e final rul e or , i

f alread y registered , ha dno t yet bee n place dint o wholesal e o r

retail commerce
. Instea dp

f meetin g th e progra mrequirement s immediately , th e intereste dproduce r

woul dappl y t o EP

A fo r adefermen t

Th e applicatio n woul d provid e detail s o n th e chemical , physical , an dfunctiona l propertie s of th e fuel o r

additiv e involved , th e purpos e o f th e requeste dtemporar y exemption , th e anticipate dvolum e of use , an dth e expecte dtoxicit y an d exposur e relatedf

o th e produc t

an dit s combustio n an devaporativ e emissions

. Informatio n require dunde r 4 0 CF R 723.5 0 coverin g exemption s fo r Premanufactur e Notificatio n unde r TSC A woul dals o b e required, lh e temporar y exemptio n woul drequire EP A approva l foUowing submitta l of th e applicatio n ari dreview b y EP A Th e temporary exemptio n woul db e availabl e onl y whe n th e us e o f th e fuel o r additiv e wa s restrictedt o experimenta l (research , developmen t an devaluation ) purposes
. N o produc t i n commercia l appUcation , ie. , wholesal e o r retail sale , woul db e eligibl e fo r th e defermen t of testing requirements. I n addition , avolum e limitatio n coul dbe ' established

. Fo r

example , th e exemptio n coul dappl y onl y t o experimenta l fuel s no t exceeding , say , 500,000 pound s pe r yea r o r experimenta l additive s no t exceedin g 2,500 pound s pe r yea r of productio n o r

consumption

. Alternatively , simila r

t o 4 0 CF R720.3 6 an d4 0 CF R780.42(a)(5 ) promulgate d unde r TSCA , n o volum e limi t

woul db e place do n productio n an duse
. provide d tha t th e us e o f th e fuel o r

additiv e wa s restrictedf

o experimenta l purposes
. Th e temporar y exemptio n woul db e goo dfor aperio do f

5 year aafte r

th e exemptio n wa s approve db y EP A bu t woul dexpir e i f th e annua l us e exceede dan y potentia l volum e limitation s o r

i f th e produc t

wa s offere dfor

wholesal e o r

retail sale

. EPA ask s commen t o n whethe r

additiona l annuall y renewable exemptio n period s shoul db e permitted

. Commen t i s als o requeste do n whethe r

volum e restriction s shoul db e establishe dand , i f so , wha t limitation s woul db e mos t appropriate

. EX

. Complianc e Consideration s A s discusse dabove , th e Tie r 1 an d Tie r 2 informatio n propose di n thi s rulemakin g mus t

b e submitte dprio r

t o registratio n i n th e cas e o f fuel s an dfuel additive s whic h ar e no t

registeredo n th e dat e of

promulgatio n of

th e final regulations (expecte dJun e 1.1993)

. Fuel s an dadditive s alread y registere d o n th e dat e o

f promulgatio n mus t compl y wit h th e regulation s withi n thre e year s followin g th e effectiv e dat e o f th e final rule

. I

f furthe r testin g an d informatio n submitta l i s require dunde r Tie r 3 provisions , aseparat e timetabl e woul db e establishe dfor

complianc e with suc h requirements. Failur e t o compl y with th e requirements of

th e rul e coul dresult

i n revocatio n of

aproduct' s registration. I n addition , direc t

financial penaltie s ar e specifie di n sectio n 211(d) o f th e statute

. Accordin g t o thi s provision , person s wh o fai l t o submi t

an y informatio n o r conduc t an y test s require db y th e Administrato r

unde r sectio n 211(b ) sha

U b e liabl e t o th e Unite dState s for acivi l penalt y of

no t mor e tha n $25,00 0 fo r ever y da y of

suc h violatio n plu s th e amoun t o f economi c benefi t

o r saving s resultin g fromth e violation

. Eac h da y afte r th e du e dat e for

submissio n o f

dat a sha U constitut e aseparat e da y of violation

. Civi l penaltie s sha U b e assesse di n accordanc e wit h section s 205(b ) an d(c) , whic h permi t EPA t o procee deithe r

i n cour t o r i n a n administrativ e action

. In addition , th e distric t court s o f th e Unite dState s hav e jurisdictio n t o compe l th e furnishin g o f informatio n an dth e conduc t o f test s require dunde r

sectio n 211(b)

. EP A woul dconside r

failur e t o submi t information , o r

submissio n of informatio n tha t

doe s no t compl y with th e requirements o

f thi s rule , t o constitut e aviolatio n o f

section s 21 1 (b ) an d(e)

. I f agrou p of

manufacturer s commit s t o performin g join t testing , eac h manufacture r

woul dseparatel y b e i n violatio n of

th e rule

. However , th e Administrato r

woul dretai n th e authorit y t o remi t

o r mitigat e an y penalty

. Becaus e EPA recognize s tha t unusua l circumstance s outsid e th e contro l o f th e manufacture r

ma y occasionaU y interfer e with th e abilit y t o compl y wit h al l o f th e provision s o

f th e rule , tiie propose d regulation s contai n mechanism s t o allo w manufactuer s f

o reques t modificatio n of th e requirements

. However , EPA expect s person s subjec t t o thi s rul e f

o submi t comment s abou t th e feasibilit y of

th e propose dtestin g requirement s durin g th e commen t period , an ddoe s no t

inten dth e modificatio n proces s f

o b e use din plac e of suc h commentary

. Instead , th e purpos e o f

th e propose dmodificatio n proces s I s t o allo w onl y person s wh o experienc e unforesee n difficultie s o r accident s i n conductin g th e neede dtest s f o request modificatio n o f

th e requirements i n orde r

t o avoi dbein g i n violatio n o f

th e rule

. However , sectio n 211(e ) requires th e requisit e (Tie r 1 an d Tie r 2 ) informatio n t o b e submitte dt o EP A for previousl y registeredproduct s withi n thre e year s afte r

th e effectiv e dat e of th e rule

. Accordingly , EP A propose s tha t

modificatio n requests mus t b e submitte da s soo n a s th e manufacture r

i s awar e of

th e difficulty , thu s prohibitin g person s fro mwaitin g unti l th e deadlin e befor e informin g EP A o f circumstance s whic h migh t preven t EP A fromreceivin g tb e dat ao n time

. X

. Confidentia l Busines s Informatio n A provisio n unde r

sectio n 211(b)(2 ) state s tha t

th e results o

f healt h effect s test s "conducte di n conformity wit h tes t procedure s an dprotocol s establishe db y th e Administrator " shal l no t b e considere dconfidential

. Thus , informatio n suppUe df

o EP A i n complianc e wit h testin g requirement s wtil b e avaUabl e t o th e publi c However , th e statut e specificaU y differentiate s betwee n healt h effect s tes t dat aan d othe r informatio n submitte dfo r registration. Thus , dat ao n produc t compositio n ari dothe r

registratio n Informatio n no t

integra l t o th e testin g progra mWi

U continu e t o b e hel di n confidence

. XI

. Publi c Participatio n EP A strongl y encourage s ful l publi c participatio n i n it s decision-makin g processes
. In additio n t o thos e area s wher e specifi c commen t

ha s bee n requested, EPA solicit s comment s o n ai l aspect s of

today's proposa l fromal l intereste dparries

. Wheneve r applicable , ful l supportin g rationale , data , an d detaile danalyse s shoul dals o b e submitte dt o aUo w EPA t o mak e maximu mus e of

th e comments

. Commenter s ar e encourage dt o provid e specifi c suggestion s for

improvement s f

o an y aspec t

o f th e proposal , especiall y i n regardt o modification s whic h coul d reduce th e cost s an dburden s o f fuel an d fuel additiv e registratio n withou t undul y compromisin g th e scientifi c accurac y of th e progra mo r

compUanc e wit h th e statutor y intent

. Al l comment s shoul db eP.5 1

1321 6 Federa l Registe r / Vol

. j 57 ; No

. 7 3 ' /

Wednesday

. Apri l 'l5, v i'99 i

. / T¥opose f dtitle s
directe dt o th e EP

A Ai r Docke t Section , Docke t No

. A-90-0 7 (se e "ADDRESSES")

. Comment s wil l b e accepte dfo

r 3 0 day s afte r

th e publi c hearin g (se e "DATES " an d

. "SUPPLEMENTAR

Y INFORMATION " i n section

. I)

. XII . Statutor y Authorit y Th e statutor y authorit y for thi s proposa l i s provide db y section s 205(b ) an d(c) , 211 , an d301(a

) o f th e Clea n Ai r Ac t a s amende d(4 2 U.S.C

. 7524(b ) an d (c ) 7545 , an d7601(a) , Publi c Law 95-95)

. XII L Administrativ e Designatio n an d Regulator y Analysis

. Unde r Executiv e Orde r

12291

. EP

A mus t judg e whethe r

aregulatio n i s majo r an dtherefor e subjec t

t o th e requirement tha t aRegulatory Impac t

Analysi s (RIA) b e prepared

. Majo r

regulations ar e

. define dt o b e thos e whic h hav e a n annua l impac t

o n th e econom y of

$100 millio n o r more , hav e asignifican t advers e impac t

o n competition , investment , employment , o r innovation , o r result i n amajo r

pric e increas e fo

r th e affecte dproduc t A regulator y suppor t

documen t

whic h present s EPA' s analysi s of th e cost s an d economi c impact s of

th e propose drul e i s avaUabl e fo

r review ir i th e pubUc docke t EP A estimate s tha t

th e cost s t o industr y for

submitta l of

th e propose d requisite dat afo

r Tier s 1 an d2 woul d tota l approximatel y $8 3 miUion incurre d ove r th e first thre e yea r

perio dafte r promulgatio n o

f th e final rule

. Thus , th e averag e annua l cos t

durin g thi s perio d woul db e abou t

$27 miUion

. I n th e subsequen t

thre e years , Tie r

3 requirements might

cos t a n additiona l $1 0 millio n annually

. Thes e projecte d overal l cost s ar e fa

r les s tha n tiie $100 miUion annua l cos t

criterio n whic h define s a"majo r

rule*'.

. Also ; th e propose drul e woul dno t

b e expecte dt o significantl y impac t

competition , investmen t

employmen t

o r innovation , o r resul t i n majo r pric e increase s i n th e industry

. Thi s propose dregulation wa s submitte dt o th e Offic e o f Managemen t an dBudge t

(OMB ) fo r review a s require db y Executiv e Orde r 12291

. An y writte n comment s fromOM B an dan y EP A respons e t o OMB' s comment s ar e availabl e i n th e publi c docke t for thi s rulemaking

. Whil e th e cost s of

th e propose d progra mwoul db e expecte dt o var y widel y betwee n variou s fuel/additiv e group s an damoun g individua l manufacturers , ahypothetica l exampl e ' ma y hel p t o clarif

y th e propose dscope , tim e frame, an dcost s of

th e program
. Base do n th e analysi s provide di n th e regulatory suppor t

documen t

apossibl e testin g scenari o an dth e associate d

complianc e cost s fo

r ahypothetica l grou p of product s i s discusse dbelo w an dsummarize di n Figure 6

. Thes e cost s woul dpertai n t o th e evaluatio n an d testin g o f afuel selecte dt o represen t th e hypothetica l group
. Th e tota l cost s woul dsubsequentl y b e share db y al l o f th e manufacturer s with product s enrolle di n th e group
. Th e requirements an dcost s assum e tha t

th e grou p consist s o f 40 fuel s an dadditive s whic h contai n n o "atypical " elements , tha t th e grou p doe s no t qualif y fo r exemptio n fro m evaporativ e emissio n testing , an dtha t adequat e existin g studie s ar e no t availabl e t o fulfil

l an y of th e speciatio n o r biologica l tes t

requirements

. Therefore , unde r

thi s hypothetica l situation , al l of

th e potentia l requirements o

f Tier s 1 an d2 mus t

b e conducted

. Combustio n emissio n generatio n procedure s ar e assume dt o b e performe dusin g on e Ught-dut y
. vehicle , fo

r both emissio n characterizatio n an dbiologica l testin g purposes
. FIGUR E 6 : HYPOTHETICA L COS T SCENARI O

Tie r 1 requirement s ' Oat a Researc h an d Analysi s Vehicl e Costs.. - Combustio n Emissio n Genera tion/SpeciatJo n . . _ Evaporativ

e Emissio n Genera tion/SpeclatJo n Tota l Tie r 1 Cost s ~ . Tie r 2 requirements Combustio n Emissio n Genera tio n Biologica l Test s o n Combos Evaporativ

e Emissio n Genera tio n Biologica l Test s o n Evapora tive Emission s Tota l Tie r 2 Costs Administrativ

e an d Reportin g Costs

. Tota l Tie r 1 , Tie r 2

. Administrative Cost s Tota l Costs Cost

$16,50 0 32,50 0 27,00 0

. 4.00 0
60.00 0

59,00 0 294,00 0 16,00 0 286,00 0

- t 655,00 0 157.00 0
692.00 0 32-2.500,00 0 3-3.500,00 0
Unde r thi s scenario , th e cos t

of conductin g al l requirement s o f Tie r 1 i s estimate da t

approximatel y $80,000

. O f this , EP A estimate s dat aresearch an d analysi s (literatur e searc h an ddat a modeling ) cost s t o b e abou t $16,500 , an d vehicle-relate dcost s (acquisition / operation/mileag e accumulation ) t o b e abou t $32,500

. EP

A estimate s acos t

of $27,000 fo r generatio n an dspeciatio n o f combustio n emissions , an d approximatel y $4,000 fo r

generatio n an d speciatio n o

f evaporativ e emissions

. Further , EP A estimate s th e cost s o

f conductin g al l Tie r

2 tes t requirement s t o tota l nearl y $655,000 unde r thi s hypothetica l example

. Includin g set-u p costs , combustio n emissio n generatio n cost s ar e estimate da t

abou t $59,000,

. whil e biologica l testin g of combustio n emission s i s estimate da t nearl y $294,000

. Th e cos t

of generatin g adequat e evaporativ e emission s t o conduc t al l Tie r 2 screenin g test s woul d b e approximatel y $16,000 , an d conductin g Tie r

2 test s o n thes e emission s i s estimate dt o cos t $286,000

. Th e administrativ e cost s fo r organizin g an dadministerin g th e grou p an dfo r reportin g th e Tie r

1 an d2 result s t o EP A i s judge dt o b e nearl y $157,000

. Addin g thi s t o th e Tie r

1 an dTie r

2 cost s provide dabov e yield s atota l cos t o f approximatel y $892,000 fo r th e grou p a s awhole

. Assumin g thes e cost s ar e incurre dove r

athree-yea r

perio dan d ar e divide dequall y amon g th e 4 0 product s i n th e group , th e cos t t o a manufacture r

with asingl e produc t

i n thi s grou p woul db e abou t $7,300 annuall y fo

r thre e years , o r

$22,000 i n total

. Let u s assum e furthe r

tha t withi n 1 8 month s o f receivin g th e group' s report. EP A determine s tha t

th e submitta l i s complet e an dtha t

th e require dTie r

1 an d2 evaluation s hav e bee n adequatel y performed

. However , anumbe r o f healt h concern s ar e raise db y th e results. Th e literature-searc h suggest s ahig h potentia l fo

r toxi c Uve

r effect s t o b e cause db y chroni c exposur e t o th e combustio n emission s o

f fuel s simila r

t o thos e i n th e group ! an dth e Tie r 2 result s indicat e anee dfor

furthe r evaluatio n of possibl e carcinogeni c an dpulmonar y effect s o f thre e emissions

. I n addition , a larg e an dwidesprea dpopulatio n i s expecte dt o b e expose dt o th e emission s of product s i n tiuagroup
. Thus , EP A determine s tha t

mor e rigorou s testin g i s necessar y unde r

Tie r 3 t o clarif

y th e potentia l risks pose db y thi s grou p o f products

. Unde r thi s hypothetica l scenario , tw o test s ar e likel y t o b e requiredt o addres s th e identifie darea s o

f concern : A two

yea r cornbine dchroni c toxicity / carcinogenicit y stud y conducte di n tw o species , an dametabolis mstud y t o elucidat e th e potentia l carcinogeni c mechanisms

. Th e grou p i s give n thre e year s i n whic h t o complet e thes e tests

. Th e tota l cost , includin g cost s for emissio n generatio n an dbiologica l testing , i s estimate da t

2 t o 2. 5 millio n dollars

. Whe n divide dequall y amon g th e 4 0 product s i n th e grou p an dsprea d ove r th e three-yea r

complianc e period , th e Tie r 3 testin g cos t

pe r produc t i n thi sP.52

_

Federa l Registe r /

Vol . 57 , No . 7 3 (

J Wednesday , ApriM5i , .199 2 /Propose d Rule s 1321 7

group woul d b e i n th e range of $17

- 21,000 annuall y fo

rthre e years . I n sum , EP A estimate s tha

tth e total cost s t o thi s hypothetical grou

p woul d range from approximatel y 3 t o 3. 5 millio n dollars , incurred ove ra seve n or eigh tyea rtime period
. Th e total cos tfor eac h produc

twoul d range from about $75,000 t o $87,500 , averagin g about$10

- 12,00 0 pe ryear . EP

A seek s comment

s o n thes e estimates , give n suc h a scenario
. Th e abov e discussio n illustrate s th e complianc e cost s whic h th e propose d progra m migh tentai l fora grou

p o f fuel/ additiv e producers . However , th e propose d progra

m coul d hav e som e indirectcos timplications , a s well . Fo r example ; i

f th e cost s of

complianc e represente d a significan tbarriert o entr y int o th e fuel/additiv e marketplace , rea l socia l cost s (includin g potential environmental costs ) coul d b e incurre d a s a resultof

delaye d o

rdeterred innovation
. Thes e potential socia l cost s hav e no ta s ye tbee n quantified , and EP A requests commen talon g wit h supporting dafa , o n ho w t o evaluat e and quantif y such indirectimpacts o f th e program. . XIV , CompUanc

e wit h Regulator

y FlexibUit y Ac t Undersectio n 60

5 of th e Regulator

y Flexibility Act , 5 U.S.C
. 60 1 et seq., th e Administrato ri s required t o asses s th e economi c impactof

thi s propose d regulatio n o n smal l busines s entities
. Accordingly , a Regulator y Flexibility Analysis (RFA

) ha s bee n prepared and i s avaUabl e i n th e publi c docket . Th e RF A compare s th e estimate d financial effect s o f th e propose d program

s o n larg e and smal l companie s a s define d b y th e Small Busines s Administration
. Usin g weighte d averag e financial statistic s base d o n a sampl e o f curren t fuel and additiv e manufacturers , th e RF A analyze s th e impacts of th e propose d progra m b y projectin g th e effects which th e estimate d complianc e cost s woul d hav e o n eac h company' s retur n o n asset s (ROA)
. Forbot h fue l an d additiv e producers , th e analysi s shows tha

tchange s i n RO

A directl y attributabl e t o th e propose d regulations woul d b e greate rforsmal l companie s tha n larg e ones . O n th e average , smal l companie s ten d t o hav e lowe r complianc e cost s than larg e companies , bu tthi s tendenc y i s outweighe d b y th e relativel y greate rvulnerabilit y o f smal l % companie s resultin g from thei rmuc h lowe rlevel s o

f asset s an d earnings
. Among fue

l manufacturers , thes e RO A effects d o no tappea rt o hav e a significan timpac tOnl y tw o smal l fue l producers i n th e sampl e woul d experienc e a reduction i n RO A b y a s muc h a s on e percent , an d non e woul d b e drive n into sever e financial distres s o rclosure . Amon g additiv e manufacturers , however , the. impacts o f th e propose d regulations appea rmore significant
. Whil e th e impacts o n larg e additiv e companie s woul d b e extremel y minor, th e analysi s projects tha t2 3 (almos tsi x percent) o f

smal l additiv e companie s migh

texperienc e a reduction in RO A t o les s than 2. 5 percen twhic h i s indicativ e of

financial stress . In addition , 1 8 smal l companie s migh tb e pushe d int o sever e financial distres s (ROA<—4 percent) , an d tw o int o closur e (ROA<—3 0 percent)
. Additional analysi s wil l b e neede d t o identif y th e specifi c factor s whic h caus e thi s subse tof

sma U additiv e companie s t o b e a tparticula rfinancial risk
. Potential allowance s forsmal l businesse s ar e discusse d abov e i n sectio n VIII.C
. XV . Complianc e with th e Paperwor k Reductio n Ac t Th e information collectio n requirements i n thi s propose d rul e hav e bee n submitte d fo rapprova l t o th e Office of Managementand Budge t (OMB) unde rth e Paperwor k Reductio n Act , 44 U.S.C
. 350 1 et

seq. A n information Collectio n Reques t documentha s bee n prepare d b y EP A (IC RNo . 309.06) an d a cop y may b e obtaine d from Sand y Farmer , Information Polic y Branch : EPA ; 40 1 M St.
. SW
. (PM-223Y) ; Washington
. DC
. 20460 o rb y callin g (202) 260-2740
. Publi c reporting burden forthi s collectio n d

f informatio n i s estimate d t o var y fro m 1 t o 1,76

8 hour s pe rresponse with ar taverag e of

440 hours pe r response, includin g time forreviewin g instructions , searchin g existin g data sources , gatherin g and maintainin g th e data needed , an d completin g th e collectio n of

information
. Sen d comment

s regarding th e burde

n estimat e oran y othe raspec tof thi s collectio n of

information , includin g suggestion s for reducin g thi s burden t o Chief , Information Policy Branch ; EPA ; 40 1 M St
. SW. , (PM-223Y) ; Washington
. DC , 20460 ; an d t

o th e Office of Information and Regulator y Affairs , Office p f Managementan d Budget , Washington
. DC , 20503 , marked "Attention : Des k Officerfor EPA"
. Th e final rul e wil l respon d t

o an y OM

B or publi c comments o n th e information coUectio n requirements containe d in thi s proposal . Listo f Subject s i n 4 0 CF

RPar t7 9 Fuel , Fue l additive
. Gasoline , Moto r vehicl e pollution
. Penalties , Incorporatio n b y reference. Dated : Apri

l 1,1992 1 Willia m K . Reilly
. Administrator. (F RDoc. 92-806

6 File d 4-14-92 ; fr.45 am

)
BILLIN G COO E SS60-S0- M