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# i^ r

Testimon

y o f Richar d Cavall i o n behal f o f th e America n Petroleu

mInstitut e o n th e U.S . Environmenta l Protectio n Agency' s Advanc e Notic e o f Propose d Rulemaking

o n Testing o f Fuel s an d Fuel s Additive s unde r Sectio n 21 1 o f th e Clean Ai r Ac t 5 5 Federa l Registe r 3221 8 (Aug . 7 , 1990 )

Ann Arbor , Michiga n Septembe r 26 , 199 0P. 3

Testimon

yo f America n Petroleu mInstitut e o n EPAANP R fo r Testing o f Fuel s an d Fue l Additive s unde r §21 1 o f th e Clean Ai r Ac t

5 5 F R 3271 8 (Aug . 7 . 1990 )

INTRODUCTION

Goo d morning . M yname i s Richar d Cavalli . I a ma toxicologis t b

ytraining an

d manage r o f produc t safet yan d healt h ris k assessmen t fo r Chevron . I als o serv e a s th e Chairman o f th e America n Petroleu

mInstitute' s Healt hStrateg yan d Respons e Tas k Force . Today , o n behal f o f AP I I' d lik e t o shar e wit hyo u API' s preliminarythinking o n th e emerging Clean Ai r Ac t §211(b ) testing rul e describe d i n th e agency' s Augus t 7 , 199 0 advanc e notic e o f propose d rulemaking .

AP I i s a nationa l trad e associatio n whos e ove r 2 0 0 membe r companie s represen t al l sector s o f th e petroleu m industry : exploration , production , transportation , refining an d marketing . Give n th e focu s o f thi s rulemaking , i t i s significan t tha t AP I member s accoun t fo r th e vas t bul k o f fuel s an d a substantia l amoun t o f th e fue l additive s manufacture d an d markete d i n th e nation . AP I member s are , therefore , directl yan d significantl yaffecte d b yth e outcome o f thi s rulemaking .

AP I wil l submi t extensiv e writte n comment s i n th e cours e o f thi s importan t rulemaking . Bu t today , a t thi s earl yformativ e stage , w e wil l addres s thre e basi c issu e areas :P. 4

- 2 - th e nee d t o focu s th e testing rule ; th e nee d t o adop t appropriat e testing methodology ; an d th e nee d t o addres s certai n critica l practica l considerations .

I . FOCUSIN

GTHE TESTIN

GRULE I n it s ANP R EP

Arecognize s tha t th e shee r numbe r o f candidat e substance s fo r testing unde r a §211(b ) rul e i s staggering . Ove r 600 0 fuel s an

d fue l additive s ar e alread yregistered . Moreover , whe n th e pending Clean Ai r Ac t Amendment s ar e passed , th e requirement s fo r alternativ e fuel s an d reformulate d gasoline s coul d increas e tha t numbe r significantly . Furthermore , i f a §211(b ) testing rul e wer e t o addres s no t onl yregistere d fuel s an d fue l additive s bu t th e man ypossibl e combination s thereof , th e numbe r o f testing possibilitie s woul d expan d further . Accordingly , AP I propose s tha t EPAemploya fewinterlinked , simplifying principle s t o reduc e th e scal e o f th e undertaking t o a manageabl e size . I f employed , thes e principle s coul d reduc e scientifi c uncertainty , whil e recognizing th e practica l limit s o f resources , but withou t compromising the statutorypurpos e o f §211(b) . First , th e §211(b ) testing progra mshoul d b e limite d t o ai r emission s attributabl e t o evaporatio n an dcombustio n o f moto r vehicl e fuels . Thi s woul d includ e no t onl ydiese l fue l an dP. 5

- 3 - gasolin e but , a s th e ANP R suggests , fuel s sucha s methanol , ethanol , liquefie d petroleu mgas , an

d compresse d natura l ga s o r an y othe r moto r vehicl e alcoho l fuel . Th e term s o f th e Clean Ai r Ac t an d it s statutoryhistorymak e i t clea r tha t §211(b ) testing wa s adde d t o th e statut e t o provid e a factua l bas e fo r the Administrator' s exercis e o f regulatoryauthorit yunde r §211(c) . Whil e §211(c ) i s broad i n some respects , giving th e Administrato r authorit yt o "contro l o r prohibit " th e us e o f fuel s o r fue l additives , tha t authority , b yth e expres s term s o f th e statute , i s limite d t o fuel s o r fue l additive s whos e "emissio n products " endange r th e publi c healt ho r welfar e directl yo r impai r t o a significan t degre e th e performanc e o f an yemission s contro l systemi n genera l use .

T o b e sure , rawliqui d fuel s an d fue l additive s hav e exposur e propertie s no t linke d t o evaporatio n o r combustio n (e.g. , eye , ski n o r ora l exposure) . However , an ytesting t o discer n thos e effect s is , w e believe , outsid e th e scop e o f th e Clean Ai r Act . Thes e othe r kind s o f exposur e ar e alread yaddresse d b

yothe r statutes . T o th e exten t thes e othe r kind s o f exposur e rais e concern s withi n th e responsibilit yo f EPA , an ytesting deeme d necessaryshoul d b e undertake n unde r th e Toxi c Substance s Contro l Ac t (TSCA) .P. 6

- 4 - Second , EPAshoul d tak e ful l advantag e o f relevan t informatio n alread ydevelope d o r being develope d outsid e th e §211(b ) testing process . Fo r example , ther e alread yexist s an databas e o n th e healt heffect s o f fue l an d fue l additiv e emissions . Thi s databas e include s anima l studies , huma n exposur e studie s an d epidemiologica l studie s o n fuel s an d exhaust .

Mor e specifically , ove r th e pas t thirtee n years , th e TSCA programha s bee n evaluating dat a needs , including healt han d environmenta l effect s testing , fo r liqui d fuel s an d fue l additives . Fo r example , during th e earl y1980' s th e Interagenc yTesting Committe e (ITC ) prepare d an d reviewe d severa l Toxicologica l Profile s o n keypetroleu msubstances , including unleade d gasoline . Specifically , th e ITC looke d a t th e healt han d environmenta l effect s informatio n availabl e o n unleade d gasoline . A s par t o f tha t study , AP I an d othe r member s o f th e petroleu m industry provide d EPAwit hdat a o n unleade d gasolin e an d assiste d th e ITC i n characterizing exposures . I n addition , th e IT C ha s als o evaluate d variou s fue l additives . Fo r example , on e o f thes e investigation s led t o th e decisio n t o conduc t a tes t progra m t o evaluat e th e healt heffect s fromexposur e t o MTBE . Third , whateve r th e univers e o f fuel s an d fue l additive s is , thos e deeme d "essentiall yth e same " shoul d b e groupe d t o avoi d duplicativ e testing . I n it s ANP R EPArecognize s thi s commonsens e principle , observing furthe r tha t th e experienc e alread ycollecte dP. 7

- 5 - i n connectio n wit hth e "substantiall ysimilar " provision s o f §211(f ) mayassis t i n grouping fo r §211(b ) purposes . AP I strongl y concurs . Wha t w e urg e EP

Ano t t o do , however , i s t o formulat e grouping criteri a o n th e basi s o f th e chemica l compositio n and/o r structura l activit ypropertie s o f rawfuel s an d fue l additive s alone . Consisten t wit hth e emissio n focu s o f th e Clea n Ai r Act , grouping fo r testing purpose s shoul d tak e int o accoun t a substance' s evaporativ e properties , a s wel l a s thos e feature s o f th e combustio n proces s an

d exhaus t treatmen t proces s tha t affec t th e typ e an d amoun t o f emission . Wit hrespec t t o exhaus t emission s specifically , th e fac t i s tha t combustio n an d exhaus t treatmen t processe s ar e designe d t o operat e o n a wid e rang e o f fuel s an d fue l additive s bu t for

ma muc hnarrowe r rang e o f emissio n products . An y §211(b ) testing progra mshoul d tak e advantag e o f thi s simplifying aspec t o f th e process . Perhap s eve n mor e relevant , th e Ai r Qualit yImprovemen t Researc hProgram , being carrie d ou t b yth e oi l an

d aut o industrie s o n a n expeditedbasis , shoul d provid e withi n th e nex t tw o year s bot ha detaile d emissio n componen t analysi s an d th e analytica l abilit yt o extend measuremen t capabilitie s t o extremel ylowlevels . Thi s progra

mwil l evaluat e th e evaporativ e an d exhaus t emission s o f seventee n differen t gasolin e formulations , a s wel l a s methano l ethanol , MTB E an

d ETB E blends , i n bot hne wvehicle s an d aP. 8

- 6 - representativ e flee t o f olde r vehicles . Thes e test s ar e being oversee n b

ya pane l o f independen t expert s fro macademi a an

d thes e dat a wil l b e give n i n thei r entiret yt o EP Aan d othe r regulatory agencies . Dat a fromth e firs t phas e coul d b e availabl e b yth e en

d o f thi s yea r o r earl ynex t year .
Th e poin t her e i s tha t thes e type s o f dat a ar e critica l fo r characterizing th e natur e an d exposur e potentia l o f moto r fue l emissions . Thes e data , whe n viewe d i n combinatio n wit hth e emission s reducing potentia l o f applicabl e regulation s an d existing emissio n reductio n technology , ar e critica l fo r shaping an d implementing th e emerging §211(b ) program . Wit hthes e dat a EP A shoul d establis ha baselin e agains t whic hth e significanc e o f exposure s ca n b e assessed , grouping s determined , an d testing priorit ydecision s made .

II . ADOPTIN

GAPPROPRIAT E TES T METHODOLOG Y

A t thi s earl ystag e i n th e rulemaking , wit hs o man ythreshol d question s unresolved , i t i s no t possibl e t o offe r th e agencya prescriptio n fo r th e selectio n o f testing protocols . Th e "shaping " consideration s AP I ha s alread ysuggeste d —

focusing o n emissions , using grouping , an

d taking ful l advantag e o f dat a no wexisting o rP. 9

- 7 - being develope d outsid e th e §21 1 (b ) progra m—al l hav e majo r implication s fo r th e selectio n o f testing protocols . Consisten t wit hth e suggestion s alread ymade , however , AP I urge s EP

At o tak e ful l advantag e o f th e standardize d guideline s fo r healt heffects , environmenta l effect s an d chemica l fat e test s tha t hav e alread

ybee n developed , recognizing , o f course , tha t some o f thes e guideline s maynee d t o b e modifie d t o sui t th e purpose s o f a §211(b ) testing program .

Moreover , w e believe , a s th e ANP R suggests , tha t a tiere d approach , properl yconstructed , coul d identif ythos e substance s tha t nee d furthe r evaluation . Thi s woul d eliminat e unnecessary testing an

d focu s limite d resource s (e.g. , limite d testing facilities ) o n th e in-dept htesting neede d i n critica l areas .

On e fundamenta l underlying questio n i s th e technica l an d scientifi c difficult yo f carrying ou t thes e evaluation s a t th e low level s o f exposur e actuall yencountered . Grea t scientifi c uncertaint yexist s fo r th e easie r bu t fa r mor e questionabl e practic e o f extrapolating exposur e effect s fro mhighe r tes t level s t o th e verylowlevel s o f actua l exposure .

Howeve r th e agencyresolve s thi s dilemma , an d whateve r screening procedure s i t employs , w e urg e th e agencyt o focu sP.1 0

- 8 - testing o n ris k evaluatio n rathe r than simpl e hazar d identification . T o th e fulles t exten t possible , th e §211(b ) testing progra

m shoul d enhanc e th e agency' s abilit yt o asses s an d compar e risk s a s th e anteceden t fo r soun d regulatoryaction .

III . ADDRESSIN

GCRITICA

L PRACTICA

L CONSIDERATIONS

I n it s ANPR , EPArecognize s tha t th e shaping o f a n appropriat e §211(b ) testing progra mno t onl yinvolve s th e selectio n o f whic h fuel s an

d fue l additive s t o tes t an d ho wt o tes t thembu t als o involve s a constellatio n o f practica l considerations : cos t an d cos t sharing , handling o f proprietarydata , avoidanc e o f undu e disruptio n o f th e moto r fue l market , an d th e nee d t o harmoniz e th e variou s §21 1 programs . I n th e detaile d writte n comment s AP I wil l submi t late r i n th e rulemaking , w e wil l addres s thes e concerns . Bu t fo r purpose s o f today' s hearing , w e wil l limi t it s remark s t o th e latte r two . First , AP I believe s tha t EPAha s th e authorit yt o implemen t a §211(b ) testing progra mi n a manne r whic havoid s inordinat e disruptio n o f th e moto r fue l market . Specifically , fo r thos e fuel s registere d b

yth e §211(b ) testing rule' s promulgatio n date , w e believ e tha t th e thre e yea r perio d fo r marketing prescribe d b y §211(e ) ca n b e extende d whil e testing i s being completed . Likewise , fo r thos e fuel s no t registere d b yth e §211(b ) testing rule' s promulgatio n date , w e believ e EPAca n issu e a temporaryP.1 1

- 9 - registration , a t leas t fo r thos e fuel s deeme d "substantiall y similar " t o fuel s alread yregistere d an

d being marketed . I n reviewing th e ANPR , i t i s clea r tha t EP Arecognize s thes e possibilities ; AP I encourage s EP At o adop t them . Second , EP

Aneed s t o harmoniz e it s differen t §21 1 programs , paying specia l attentio n t o an ynewfue l certificatio n progra m establishe d b

yth e Clean Ai r Ac t Amendment s no wpending befor e Congress . T o some extent , th e ANP R doe s addres s th e relationshi p betwee n th e emerging §211(b ) progra man d th e existing §211(f ) "substantiall ysimilar " program , eac ho f whic hmayinvolve testing . Whe n Clean Ai r Ac t Amendment s ar e enacted , i t wil l become cleare r t o EPAan

d industryjus t wha t need s t o b e don e t o harmoniz e thes e tw o program s wit han yne wfue l certificatio n program . Bu t her e again , w e believ e EP Aha s ampl e authorit yunde r th e existing Clean Ai r Ac t t o harmoniz e al l thre e programs .

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AP I recognize s tha t th e formulatio n o f a §211(b ) testing programpose s man

yissue s involving highlevel s o f scientifi c uncertaint yan

d whos e resolutio n involve s majo r resourc e implication s fo r EPAan d industry . AP I welcome s th e opportunit yt o participat e i n thi s proces s an d hope s EP

Awil l tak e ful l advantag e o f th e expertis e w e hav e t o offe r i n wha t promise s t o b e an extensiv e an

d challenging rulemaking .