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ENVIRONMENTA L PROTECTIO N AGENC Y

DOCKE T NO . A-90-07 TESTIMON Y FUEL S AN

D FUE L ADDITIVE S REGISTRATIO N PROGRA M NOTIC E O F PROPOSE D RULEMAKIN G (5 6 FED.REG . 13168 , APRI L 15 , 1992 )

Presente d b

y Dr . Joh n Sepes i o n behal f o f Th e American Petroleu mInstitut e

Ma y 28,199 2 An n Arbor , M IP. 3

TESTIMON

Y AMERICAN PETROLEU M INSTITUTE befor e TH E ENVIRONMENTAL PROTECTIO N AGENC

Y Proposed Fuel s an

d Fue l Additive s Regulations (40 CF RPar t79 ) Ma y 28,199 2 An n Arbor , M

I

I . INTRODUCTIO N M y name i s Joh

n Sepesi . I a

mher e toda y o n behal f o f the America

n PetroleumInstitute t o respon d t

o th e propose d regulatio n fo r Fuel s an d Fuel Additive s unde

r Sectio n 21 1 o

f th e Clea n Ai r Act . AP I i s anationa

l trade associatio n wit

h ove r 25 0 membe

r companie s tha t represent al l aspect s o

f the petroleumindustry . AP I member s accoun

t fo r th e vas t bul k o f fuel s manufacture d an

d marketed i

n thi s country . II . OVERVIE

W There ar e thre e majo

r principle s tha

t should b e applied i

n th e fuel s an

d fue l additive s rulemaking : (1 ) Becaus e th e propose d reeulatio n goe s t o th e hear t o f the petroleumindustry' s busines s

- makin g fuel s fo

r automotiv e vehicle s - we believ e tha t it should encourage , no t

interfer e with , th e manufacturin g o f reformulated gasolin e mandated unde r the Clea n Ai r Ac t Amendment s o

f 1990 . A n all ou t effor t should b e mad

e t o avoid timing conflict s wit h th e recentl y propose d reformulate d gasolin e rule , a s well a s othe r ke y regulation s tha

t wil lP. 4

follow . T o avoi d duplicatio n o f effor t an d assur e consistenc y o

f definition s an

d requirements , th e Fuel s an

d Fue l Additive s Regulatio n shoul d buil d on existin g regulator y programs , suc h a s EPA' s "substantially similar " regulations . (2) Th e rul e mus t

b e crafted t

o allo w manufacturer s t

o tak e ful l advantag e o

f th e us e o f existin g informatio n o

n emission s speciatio n an

d potentia l publi c healt

h impacts . W e fee

l strongly tha

t th e rul e shoul d recogniz e th e substantia l emission s speciatio n datadevelope d unde r th e multi-millio n dolla

r Auto/Oi l Ai

r Qualit y Improvemen

t Research Program . Tha

t progra mha s develope d state-of-the-ar t capabilit y i n emission s speciation , an

d should no t b e exceede d b

y th e requirement s o

f thi s rule . Likewise , scientificall y vali d an d relevant toxicologica

l an d exposur e studie s done i

n the pas t mus t b e abl e t o b e used t

o fulfil l Tier s I an d I I requirements , an

d no t b e limite d b

y wha t w e believ e i s a

n unnecessarily restrictiv e definitio n o

f wha t constitute s "adequate " datai n the propose d rule . (3 ) Reasonabl e requirement s mus t b e se t s o tha t manufacturer s ca

n compl y within th e three-yea r timefram e without sacrificing scientifi c integrity . I canno t conve y to o emphaticall y th e reservation s tha t AP I ha s o n thi s point

becaus e of

th e lack o f current facilities , an

d eve n mor e significant , th e lack

o f accepte d scientifi c method s t o perfor m som e o f th e studie s proposed . AP I feel s strongly tha

t an y testin g tha

t i s require d unde

r thi s rul e mus t

confor mt oP. 5

accepte d scientifi c method s an d protocols , s o tha

t resultin g datawill stan

d u p to scientifi c peer-revie w an

d b e capabl e o

f integratio n into the existin g testin g information . It shoul d als o b e researc h that , o

n it s face , add s valu e t

o the bod y o f knowledg e o

n th e subject , wil l assis t EP A in evaluatin g potentia

l advers e effects , an

d i s specificall

y directe d to th e determinatio n o

f whethe r furthe r ris k assessmen

t o r regulator y actio n i s needed unde

r Sectio n 21 1 (c) . Addin g datarequirement s fo r purpose s tha

t ar e inconsisten

t wit h thi s statutor y goa l is , a t best , inappropriate , an

d a t worst , a n unacceptabl e wast

e o f th e nation' s environmenta

l researc h capability . AP I endorse s man

y o f th e concept s in th e propose d rul e suc h a s th e tiere d testin g approach , an

d th e fuel s groupin g option ( Option B ) whic h place s all "sub . sim. " an d waivere d fuel s an

d additives , includin g reformulated gasolin e (RFG) , i n th e baselin e group . W e believ e tha

t th e correc t

focu s o f the rul e i s o

n tailpip e exhaus t

rather tha n ra w fuels . Ou r comment s wil l contain suggestion s fo r som e revision s to th e proposa

l tha t w e believ e will improv e implementatio n o f th e rule . AP

I will file extensiv e written comment s in June . III . NEED T O NO T INTERFER E WIT H CA A AMENDMENT S Concurren t wit h thi s rulemaking , EP

A i s als o developin g regulation s fo r Reformulate d Gasolin e Certificatio n Requirement s unde r the Clea n Ai r Ac t Amendment s o

f 1990 . I t i s acomplicate d matte

r base d o n principle s agreed upon in th e length y regulator

yP. 6

negotiation . I t

establishe d procedure s fo r certifying reformulate d gasolin e b y vehicl e testin g o r us e o f apredictiv e model . Eithe

r th e simpl e or

comple x model ca

n b e used fo

r certificatio n o

f RF G fro m1995-1997 . Th e comple x mode l i s th e onl

y allowabl e mode

l fro m199 7 onward . Th e us e o f the comple

x mode l i s aparticularly importan

t par t o f tha t rulemakin g becaus e i t

wil l provide the flexibilit

y necessar y fo r refiner s t o produc e RF

G i n acost-effectiv e manner . Becaus e o f the timetabl e fo

r the regulation s o

n th e comple

x model , API i s concerne d tha t thi s registratio n rul e migh t limi t th e abilit y o f fue l an d additiv e manufacturer s t

o mov e forwar

d speedily wit

h th e entranc e o

f RF G into th e market . O

f particula r concer n i s tha t healt h effects datafo

r Tier s I an

d II mus t b e presente d to EP

A befor e registratio n wil l b e grante d to an y fue l tha t i s no t registere d b y Jun e 1,1993 . Becaus e the complex mode l fo r ne w RF G will not b e availabl e unti l March 1993 , a t th e earliest , i t

would b e mos t

difficul t t o registe r a n RF G unde r th e complex model befor

e th e Jun e 1 deadline . IV . FUE L AN

D ADDITIVE S GROUPIN G Th e propose d rul e present s tw o majo r option s fo

r grouping o

f fuels . API strongly support s Optio n B . Thi s would allo w th e "substantially similar " regulation s fo r fuels , a regulator y progra mwhic h i s i n plac e an d working , t

o b e the basi s fo

r Baselin e grouping . Base d o n th e experienc e tha

t EP A ha s wit h tha t program , a s well as th e researc h findings t o date fro mth e Auto/Oi l Ai

r Qualit y Improvemen

t Research Program , ther

e i s n o technica l o r scientifi c nee d fo

r reformulate d gasoline s t

o b e include d in aNon-Baselin eP. 7 I. .

categor

y - - especially sinc e RF

G will , b y definition , hav e lowe

r toxi c emissions . Inclusio n o f RF G i n th e Baselin e categor y will avoi d unnecessar

y duplicatio n o

f testin g o f essentiall y simila

r materials . Furthermore , suc h grouping would avoi d potentia l timin g conflict s fo

r reformulate d fuel s an

d additive s tha

t will b e "sub . sim. " o

r "waivered" , but ma y no t b e registere d b y th e time thi s regulatio n become s final.

W e believ e tha

t an y gasolin e or

diesel fue l o r additiv e - whethe

r i t i s currently marketed , whethe r i t i s reformulated , o

r whethe r it i s registere d befor

e o r afte r thi s regulatio n become s effectiv e - shoul d b e include d i n the Baseline categor

y based solely o

n it s conformanc e wit

h the definitio n o

f "sub . sim. " o

r "waivered" . An

y tes t substanc e should represent bot h th e fuel s an

d th e additiv e packag e tha t i s within the Baselin e definition . Ther e i s n o appreciabl e differenc e i n th e emission s amon

g thi s broa d grouping tha

t would warrant amor e complex grouping system . Th e Non-Baselin e categor y i s properly hel d fo

r product s containin g onl

y baselin e elements , but

i n concentratio n limit s tha

t excee d substantially simila r or waivere d criteria . W e concur

wit h EP A tha t th e atypica

l categor y should b e fo

r fuel s an d additive s tha

t contai n uniqu e chemica

l element s beyon

d thos e recognize d by th e "sub . sim. " rule , an d tha t hav e bee n intentionally added .P. 8

V . TH E DEFINITIO N O F WHA T DAT

A CA N B E USE

D T O SHO

W "ADEQUAC

Y O F EXISTIN G DATA " IS TO O NARRO W A . HEALTH EFFECT S INFORMATIO N / TOXICOLOG

Y DAT A I n Sectio n 211(e)(3) , Congres s authorize s EP A to tak e existin g informatio n into accoun t t o avoi d duplicativ e testin g requirements . AP I believe s tha

t th e propose d rul e contain s suc h anarro w definitio n o

f wha t constitute s "adequat

e existin g testing " tha

t th e purpos e o f th e regulatio n become s one o f require d testing , no t

o f determinin g potentia

l advers e publi c healt

h risk . EP

A i s proposin g tha

t existin g studie s ca

n onl y b e relie d upon i

n lie u o f Tier I I test s i f the y confor mt o (o r ar e "reasonabl

y comparabl e to" ) the guideline s fo r Tier I I tests , a s outline d i

n th e proposal . We believ e thi s i s a n unnecessarily rigid approach , particularl y becaus e mos t o f the propose d testin g methodolog y break s ne w scientifi c ground , an

d therefore , fro

mtha t perspective , prio r

studie s coul d wel l b e judge d no t to conform . Thi s limitatio n i

n us e o f existin g dat

ai s i n direc t contras t t o EPA' s propose d literatur e search strategy , whic

h i s quite broa

d an d inclusive . I

t include s historica

l review , an

d stud y o f individua l emissio n product s a s well a s whol e exhaust . A s proposed , i t require s analysi s o f al l relevant

scientifi c information , includin g emission s speciation , tha t ma y shed light on th e potentia

l healt h an d welfar e effect s o f th e fuel/additiv e in question . In establishin g th e adequac y o f existin g data , registrant s mus t b e abl e t o us e thi s sam

e approach . Al l vali d an

d relevant scientifi c information that , take n together , allow s a

nP. 9 I..

informe d assessmen t o f th e potentia

l healt h risk o f exposur e t o vehicl e emission s mus t

b e considered . Th e definitio n o

f wha t constitute s adequac y would als o preclude all bu t studie s o f whol e emissions . But , i t

shoul d b e noted tha

t ther e ar e substantia

l amount s o

f datao n th e majo r constituent s o

f motor gasolin e an

d diese l fue

l vehicl e emissions . Thi s informatio n i s sufficien t t o mak e reasone d scientifi c judgment s a s t o th e potentia

l fo r toxicit y o f th e define d endpoints . I

t i s especially relevant

whe n one consider s tha

t th e ambien

t urba n concentration s fo

r thes e constituent

hydrocarbon s ar

e i n th e parts-per-billio n range . Even i n th e exhaust , the

y ar e asmall fractio

n o f th e total . Suc

h existin g informatio n i s mos t certainl y relevant

t o th e issue s a

t hand , eve

n thoug h conducte d o

n th e constituents , becaus e i n reviewin g ambien

t air monitorin g dataone ca

n onl y conside r constituents . Mos t studie s conducte d b y EP

A an d other s t o asses s ambien

t environment s ar

e base d o n concentration s o

f specifi c constituents . B . EMISSION S SPECIATIO N DAT A Th e propose d rul e contain s detaile d an d comple x requirement s fo

r the speciatio n o

f emissions , in bot

h th e fue l grouping s an

d the emission s generatio n sections . Ther e i s a significan t researc h progra

munderwa

y i n thi s countr

y tha t addresse s thes e speciatio n question s i

n grea t detail , an d tha t researc h represent s the state-of-the-ar t i n emission s speciation . I t

i s th e Auto/Oi l Ai

r Qualit y Improvemen

t Research Program , jointl y funde d 8P.1 0

by th e petroleu man

d automotiv e industries . Thi s researc h should provide th e gasolin e emission s speciatio n informatio n require d unde r thi s program . Furthe

r speciatio n a s prescribe d in th e proposa

l i s beyon d the capabilit

y o f current technology . VI . PROPOSE

D TESTIN G GOE S BEYON D TH E STATE-OF-THE-AR

T I N METHOD S AN

D QUALIFIE

D TESTIN G FACILITIE S API i s greatl y concerne d tha t muc h o f the toxicolog y testin g being propose d involve s untrie d scientifi c method s an d unverified protocols . Eve n i n case s wher

e ther e ar e establishe d protocols , th e generatio n o f emission s an

d deliver y o f controlle d dose s t

o animal s pos e significan

t difficulties . Example s o

f majo r technica l problem s are : Th e dilutio n facto

r necessar y t o delive r the tes t substanc e t

o the animal s i s no t known , an d trial s will hav e t

o b e conducte d t

o determin e wha

t i s appropriate . Th e standar d eight-fol d dilutio n facto r suggested i

n the proposa

l ma y no longe

r b e appropriat e becaus e o

f change s i n emission s contro l systems . A metho d o

f coolin g th e exhaus t

an d controllin g th e oxyge

n suppl y wil l need to b e develope d an

d tria l teste d s o tha

t th e appropriat

e environmenta

l condition s ca

n b e maintaine d t

o suppor t the tes t animals .L . P.1 1

Th e deliver

y o f th e tes t substanc e t

o the animal s mus t

b e accomplishe d directly - tha t i s fro mrunnin g vehicl e t

o th e animal . Thi s mean s th e facilitie s mus t b e i n proximity , an

d tha t confounding variable s o f nois e an

d vibratio n mus t

b e engineere d ou

t befor e avali d stud

y could b e run . Th e availabilit

y o f testin g facilitie s will b e amajo r problem . T o th e bes t

o f ou r knowledge , testin g facilitie s will hav e t o b e constructed . Ther

e ar e existin g laboratorie s tha t generate emissions , an

d ther e ar e existin g laboratorie s tha t perfor mtoxicolog y research , but

w e kno w of

n o testin g facilit

y tha t i s prepare d no

w to conduc t

thes e studie s a s proposed . Testin g unde r thi s propose d rul e would requir e thos e tw o capabilitie s t

o b e integrated , an

d tha t mean s appropriat

e tes t facilitie s will nee

d t o b e constructed . There ar e companie s tha

t w e believ e ca

n develop the capabilit

y o f conductin g thes e tests , onc e method s ar

e developed , but

the y d o not currently hav e the facilitie s necessar y t o perfor mth e studie s a s proposed . Th e desig n an d constructio n o

f laborator y facilitie s i s costl y an d seem s no t

t o hav e bee n considere d i

n EPA' s cos t

estimate s fo

r thi s regulation . W e d o no t believ e tha

t i t wa s Congressiona

l inten t fo r registrant s t

o buil d ne w laborator

y facilitie s an

d develo p ne

w method s i

n orde r t o fulfil l registratio n requirement s tha t mus t b e complete d within thre e years .

1 0P.1 2

VII . SCIENTIFI C METHOD S AN D PROTOCOL S MUS T B E TESTED , VERIFIED , AN

D ACCEPTE D WITHI N TH E FRAMEWOR K O F GOO D SCIENTIFI C PRACTICE S An y testin g tha

t i s conducte d unde

r thi s regulator

y progra mmus t stand u p to scientifi c scrutiny . Testin g result s o

f ou r product s ar

e o f critica l importanc e t

o th e industry , an

d w e ar e concerne d tha

t usin g untrie d scientifi c method s an d abbreviate d tes t

protocol s wil l render stud y result s meaningless . Whil e we appreciat e th e Agency' s opennes s t o innovativ e tes t

protocols , th e tim

e an d mone y save d b y suc h change s will b e minimal , an d fa r outweighe d b

y the cos t o f developin g method s an

d buildin g facilities . API doe s no t believ e tha

t Congres s intende d t

o compromis e scientifi c method s in orde r to meet th e three-yea r timeframe . W e d o not

wish t o see afinal rul e tha

t would develo p tes t guideline s outsid e th e accepte d practice s o f th e scientifi c community . VIII . TIMIN G FO RSUBMISSIO N O F TIE RI AN D I I DAT

A FO RALREAD Y REGISTERE D FUELS/ADDITIVE S There ar e severa l timin g issue s o

f concer n i n the propose d rule . I

n additio n t

o th e potentia l conflict s fo

r RFG , th e othe

r timin g issue s ar

e relate d t o the timin g o

f Tier s I an d I I revie w fo

r thos e fuel s an

d additive s tha

t ar e registere d whe

n the rul e become s effective . Congres s allowe d thre e year s fo r submission o

f data . Whe

n Congres s include d th e three

yea r timefram e fo r submission o

f initia l information , we believ e tha t the y envisione d requirement s tha

t coul d b e complete d within tha t period . Indeed , wit

h commoditie s such 1 1P.1 3

a s fuel s an

d additive s tha

t seem s the onl

y economically wis e interpretation . EP A ha s discretio n to determin e wha t "requisit e information " should b e submitte d t o th e Agenc y within th e three-yea r timeframe . W

e believ e tha

t wha t i s propose d goe s wel l beyond th e capabilit

y o f wha t ca n b e accomplishe d i

n thre e years . W e hav e addresse d the absenc e o f facilitie s an

d the nee d t o develop an

d tes t ne w inhalatio n toxicolog y method s to perfor msom e o f thes e studies . Th e cos t

t o d o thi s i s no t accounte d fo

r i n th e rule , nor

i s the time . Development , constructio n an d testin g canno t occu r in thre e years . Furthermore , i

f registrant s wan

t t o rely o n existin g datawhich we believ e t o b e "adequate" , the timefram

e i s s o shor

t tha t w e could not

gambl e o n EPA' s approva

l without conductin g som

e back-u p testin g i n orde r t o ensur e tha t registratio n wil l not

b e withdrawn a t the en d o f the three-yea

r period . Finally , th e initia

l requirement s will appl

y t o al l fuels/additive s registere d i n the sam e timeframe , makin g th e availabilit y o f tes t facilitie s eve

n les s likely . I

f testin g o n mor e tha n on e endpoint

fo r mor e tha n one fue l o r additiv e ha

d t o b e done concurrently , i t

i s eve n mor e unlikely tha

t th e three-yea

r deadlin e ca

n b e met . 1 2P.1 4

Clearly , th e propose d requirement s fo r th e initia

l three-yea

r perio d surpass : (1 ) th e capabilit y o f current scientifi c methods , (2 ) th e availabilit y o f facilities , (3 ) th e abilit

y fo r EP A to analyz e Tier

I submissions , whil e still allowin g tim e fo r subsequen

t testing . Thes e ar e critica l matter s within th e rule , becaus e the penalt y outline d - principally the withdrawa l o f th e right t o market - i s substantial . IX . CONCLUSIO N There ar e anumbe

r o f important

issue s w e hav e no t

addresse d i

n thi s hearing . Fo r example , diese l fue

l registratio n i s quit

e importan t to the petroleumindustry , bu t w e hav e focused primaril y o

n gasolin e becaus e o

f the Clea n Ai r Act Amendment s o

f 199 0 which will affec t formulatio n an

d marketin g o

f gasolin e i

n th e nea r future . We hav e no t addresse d evaporativ e emissions , an d do no t believ e ther

e i s an y need fo

r furthe r evaluatio n o

n evaporativ e emission s becaus e o f the existenc e o

f othe r legislative/regulator

y requirement s t

o reduc e an

d contro l suc

h emissions . W

e agre e wit

h EP A tha t evaporativ e emission s fro

mdiese l fue

l ar e no t significan t du e t o the lo w volatilit

y o f thi s material . API' s writte n submissio n i n Jun e will provide detaile d comment s o n th e ful l rang e o f topic s outline d in th e preamble . It i s ou r inten t t o wor k wit h EP A t o mak e thi s a reasonabl e regulator

y program . We will strongl y resis t efforts t o mak e i t atestin g progra mfo r which th e result s d o no t

ad d valu e t o ou r abilit y t o asses s potentia

l publi c healt h o r welfar e risk. 1 3W e wil l strongly encourag e th e Agency to mak e ful l us e o f th e ongoin g Auto/Oi l researc h an d o f existin g regulator

y program s such a s "sub . sim. " an d th e waive

r program , s o tha

t th e fuel s registratio n proces s doe s no t provid e abarrie

r t o the developmen

t o f ne w an d cleaner fuels .

1 4