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# OAR Box 1846 Prepped by Ollie Stewart



## Document

Number: 

# 56 ) ll-H- 4 Docket Number: 

# A-90-0 7

Printed 11/18/20087:30:16

AM Sheet 56 of 93P. 2

. . . • » u 

# jr - H-I+

Environmenta l Protectio nAgenc y

Docke t No . A-90-0 7

TESTIMONYO

N TH E FUEL S AN

DFUE L ADDITIVE S REGISTRATION PROGRA

M ADVANC E NOTIC E O F PROPOSE DRULEMAKIN G \ ; , • •x - 

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# I**'

Presente dby : Charle s Kelle r o nBehal f o f th e Chemica l Manufacturer s Associatio n Petroleu

m Additive s Pane l

Septembe r 26 , 199 0 AnnArbor , Michiga nP. 3

I . Introductio

nan dBackground :

M yname i s Dr . Charli e Kelle r an d I a mher e toda

yrepresentin

g the Chemica l Manufacturer s Associatio n (CMA ) Petroleu mAdditive s Panel . Th e CM APetroleu

mAdditive s Pane l represent s a grou p o f majo r manufacturer s o f fue l an d lubrican t additiv e components . Th e followin g companie s ar e represente d o n th e Panel : Amoc o Petroleu mAdditive s Company ; Lubrizo l Petroleu mChemica l Company ; Ethy l Corporation ; Oronite-Chevro n Chemica l Company ; Paramins-Exxo n Chemica l Company ; Texac o Chemica l Company ; an d Mobi l Chemica l Company .

Fue l additive s ar e specialt ychemical s whic har e generall ysol d a s proprietar

ymixture s t o refiner s an d marketer s o f gasolin e an d distillat e fuels . Fue l additive s ar e critica l t o the operatio n o f modern emission-controlle d engines . Theyac t a s antioxidants , preven t fue l injecto r fouling , reduc e o r preven t valv e deposit s an d provid e a hos t o f othe r performanc e features . Thes e function s o f fue l additive s hav e become increasingl ycritica l t o maintaining engin e emissio n contro l i n recen t years .
Whil e there i s a tendencyamong th e genera l publi c t o view chemical s a s environmentall yharmful , ou r industr yproduce s fue l additiv e chemical s tha t hav e mad e a substantia l contributio n t o maintaining lo

wemission s i n moder n engines . I n th e ANPRM , EP Astate s tha t ther e ar e currentl y379 0 activ e registration s fo r fue l additives . Whil e thes e ar e no t al l distinctivel ydifferen t products , w e believ e thi s reflect s th e dynamic , innovative natur e o f fue l additives . Th eP. 4 Pag e 2

fue l additiv e industr yha s worke d har d i n recen t years , an d spen t considerabl e researc h and developmen t money , t o mee t th e challeng e o f fue l system s an d engine s tha t ar e mor e sensitiv e t o deposi t formation .

II . W e urg e EP At o clearl yfocu s thei r effort s t o develo p testin g regulation s whic h addres s "real " concerns , consisten t wit hEPA' s authorit yunde r th e Clea n Ai r Act .
Th e ANPR M raise s a ver ylarg e numbe r o f question s an d unresolve d issues , manyo f whic h affec t fue l additives . W e believ e thi s broa d uncertaint yi s a n inevitabl e consequenc e o f th e wid e scop e o f th e testin g envisione d i n th e ANPRM . Th e issue s an d question s raise d i n th e ANPR M includ e comple x technica l issue s o n emissio n an d toxicolog y testing , a s wel l a s issue s o f publi c policy , ris k assessmen t an d th e relationshi p o f thes e propose d regulation s t o existin g EP Aregulations .

Fo r example , w e believ e tha t th e ANPR M suggest s toxicit ytestin g whic h woul d probabl yg o beyon d th e limit s o f establishe d methodolog y an d technology . Whil e ther e ha s bee n som e toxicit ytestin g o f combustio n emissions , thi s testin g ha s no t encompasse d th e broa d spectni a o f toxicit yendpoint s th e ANPR M identifies . Furthermore , thi s testin g ha s bee n directe d a t answerin g ver ynarro wresearc hquestions . W e ar e no t confiden t tha t methods/an d protocol s hav e bee n develope d t o th e poin t wher e the ycoul d b e justifiabl yuse d fo r th e wide-scal e screenin g o f fuel s an d additive / emission s suggeste d b yth e ANPRM .P. 5 Pag e 3

•A n importan t technica l aspec t o f thi s problemi s the selectio n o f a n appropriat e baselin e in orde r t o compar e an d asse s the toxicityo f emission s fro

mnewfue l an

d additiv e combinations . W e believ e i t coul d tak e years , an

d million s o f dollars , jus t t o develop an d validat e a "baseline " an

d protocol s fo r testing combustio n emission s in a n inhalation toxicit ytest . Thi s effor t woul d requir e basic , fundamenta l researc ht o selec t the mos t appropriat e fuel , fue l additives , engin e type , engin e operating condition s an d anima l exposur e procedures . In addition , the "baseline " procedure s woul d hav e t o b e ru n ove r time i n severa l laboratorie s t o validat e th e method , an d t o establis h statistica l contro l limits .

In additio n t o statistica l variabilit yi n th e emissions , anothe r technica l problemi s definitio n an d contro l o f the variabilit yin anima l response . A s an example , the EP Ashoul d reviewthei r histor yi n developing testing guideline s unde r th e Toxi c Substance s Contro l Act . Eve n thoug

hthes e wer e originall y"off-the-shelf " testing methodologies , EP

Aexpende d substantia l effor t defining an d codifying thes e guidelines . W e believ e tha t developing an d validating tes t standard s fo r emission s toxicit ytesting woul d requir e a massiv e effor t o n EPA' s part .
Ou r reviewo f th e Publi c Docke t fo r th e rulemakin g suggest s tha t EP Arecognize s the absenc e o f validate d toxicit ytesting protocol s an d method s t o asses s exhaus t an d evaporativ e emissions . T o quot e fro ma n Octobe r 5 , 198 9 interna l memorandu m(Docke t //A-90-07 , II-B-3 ) whic h summarize d literatur e reference s o n fue l toxicity :P. 6 Pag e 4
"Whil e thes e reference s appear t o b e numerous , the

yd o no t reall y addres s th e keyissue s tha t wil l fac e u s i n th e rulemaking . Specifically , non e o f th e studie s ar e devote d t o a principl e topi c o f th e rulemaking : wha t testing procedure s an d protocol s ar e bes t suite d t o determining th e healt han d welfar e effect s o f fuel s an d fue l additives. "
Beyon d the example s I'v

e cite d today , w e believ e ther e ar e othe r example s o f technica l o r practica l concern s whic hwoul d presen t obstacle s t o the testing progra menvisione d i n th e ANPRM . W e recogniz e th e challeng e whic hEP Aface s i n sorting throug hthes e issue s t o develop a focu s for rulemaking .

III . Ou

r positio

ni s strengthene

db y th e legislativ

e historyo f thi s issue .

T o hel p focu s on a directio n fo r rulemaking , w e believ e tha t i t i s helpfu l t o examin e the legislative debat e i n 197 0 an d 1977 . I n thi s regard , w e examine d th e document s containe d i n th e publi c docke t for thi s rulemaking . Th e origina l 197 0 Clean Ai r Ac t was , i n fact , a n amendmen t o f predecesso r provision s i n th e 196 7 Act , nowincluded i n Sec . 211(a) , 211(b)(1 ) an d 211(b)(3) . I n 1970 , the legislative debat e o n fuel s an

d fue l additive s focused almos t exclusivel yo n th e us e o f lea d compound s a s anti-knoc k additives . Whil e th e EPA' s predecesso r had some powers , i t wa s clea r tha t Congres s believe d tha t theylacked the statutor

ybasi s t o regulat e o r ba n lea d i n gasoline . I t wa s thi s Congressiona l objectiv e whic hle d t o th e incorporatio n o f the "ma yals oP. 7 Pag e 5 require " testing provisio n nowgrante d i n Sec . 211(b)(2) . However , i n our reviewo f the docket , w e di d no t fin d a singl e referenc e t o ' Congressiona l concern for an yspecifi c fue l additiv e othe r tha n lea d anti-knoc k compounds .

In the 197 7 Amendmen t process , Congressiona l debat e als o wa s ver y narrowl yfocused . I n 1977 , th e fue l additiv e concern s o f Congres s focused on the us e o f a singl e additiv e chemical , an d ther e wa s ver

y limited mentio n o f concern ove r the genera l us e o f fue l additives . In addition , i t appear s fro mCommitte e summarie s a s thoug hCongres s wa s primaril yaddressing the issu e o f fue l additiv e effect s on vehicl e emissio n contro l system s a s regulate d unde r Sec . 211(b)(2)(B ) whe n they drafte d th e Sec . 211(e)(1 ) mandate . Despit e thes e apparentl ynarrow concerns , Congres s adde d Sec . 211(e ) t o the Act , whic hrequire d EP At o promulgat e regulation s unde r Sec . 211(b)(2) .
CM Abelieve s tha t th e EP Ashoul d conside r informatio n i n the docke t relevan t t o the 197 0 an d 197 7 Clean Ai r Amendment s o f Sec . 211 . I f EP Aagree s tha t Congres s focuse d onl yo n a coupl e specifi c additiv e chemical s o f highconcer n t o them , an d o n combustio n emissions , the n thi s woul dserv e t o focu s thi s rulemaking .P. 8 Pag e 6

IV . Clea nAi r Ac t consideration s provid e furthe r guidanc e for thi s rulemaking .
Turnin g no wt o th e statutor yrequirements , th e 197 0 Clea n Ai r Ac t Amendment s di d no t provid e EP Awit hclea r direction s fo r rulemaking . Instead , EP Ai s give n grea t latitud e an d discretio n i n regulatin g testin g o f fuel s an d additives . Th e Clea n Ai r Ac t state s i n Sec . 211(b)(2)(A ) that :

"th e Administrato r may als o requir e th e manufacture r o f an y fue l o r fue l additiv e t o conduc t test s t o determin e potentia l publi c healt heffect s o f suc hfue l o r additive... "

Th e conditiona l phras e "may als o require " i s critica l t o th e ANPR M an d rulemakin g a s i t allows , an dfor tha t matte r eve n mandates , tha t EP Autiliz e it s judgmen t i n preparin g th e regulation s require d bySec . 211(e) . A s note d i n th e ANPRM , th e legislativ e histor yo f th e 197 7 amendment s t o th e Clea n Ai r Ac t indicate s Congress ' inten t tha t testin g regulation s no t be undul y burdensome , an

dtha t cost s shoul d als o b e considered . Yet , th e ANPR M recognize s tha t th e Sectio n 21 1 progra mi s potentiall y

"vas t inscope " wit hpotentia l seriou s advers e economi c impact s a s a resul t o f undu e testin g burdens . T o quot e fro mth e ANPRM :

"I nexercisin g it s regulator y judgment , i t i s EPA' s inten t t o develo pa workable , usefu l progra a whic hsatisfie s th e goal s o f th e Act , allow s fo r th e adequat e assessmen t o f potentia l health ,P. 9 Pag e 7

welfare , an

demissio ncontro l syste m performanc e impact s a s required , bu t doe s no t introduc e a ninfeasibl e o r needles s testin g burde no nth e producer s o f the fuel s an dadditives."

T o us , th e ANPR M suggest s tha t EP Ama yb e interpretin g th e "ma y als o require " languag e t o mea n "shal l require" . A t thi s stag e o f rulemaking , w e believ e thi s emphasi s o n broad-base d testin g i s premature . Effective , mor e focuse d option s for healt han d environmenta l protection , whic hinclud e testing , ma yno t hav e bee n give n sufficien t consideration .

W e believ e th e EP Amus t focu s thei r rulemakin g t o mee t bot hth e legislativ e inten t an d th e statutor ylanguag e whic hmandate s reasonabl e discretion . Again , t o quot e th e ANPRM :

"Th e progra

m desig nneed s t o focu s o nth e potentia l effectivenes s o f a give nregulator y requiremen t i nmeetin g th e goal s o f th e Ac t an dwhethe r th e result s o f suc hrequirement s wil l provide usefu l informatio nfo r decisio nmaking. "

Th e ke y

t o meaningfu l decisio nmakin g i s t o identif y th e objective s an

dintende doutcome s up-front . Th e decisio nmakin g proces s shoul dlea

dt o a decisio nwit hrelevanc e t o environmenta l o r healt h concerns .

The curren t ANPR

M addresse s a very larg e numbe r o f broa dissue s bu t doe s no t identif y specifi c environmental , healt ho r publi c welfar eP.1 0 Pag e 8
issues , concern s o r problems . I n some way s the ANPR M appear s t o b e a solutio n i n searc ho f a problem . Th e possibilit yo f a "vas t scope " o f testing , on possibl yhundred s o r thousand s o r products , raise s the dange r tha t thes e regulation s coul d needlessl ydisrup t the us e an d innovatio n o f additive s wit hprove n valu e i n the reductio n o f emissions . Th e potentia l cost s o f testing coul d easil ylea d t o reduce d researc han

d innovation , an

d produc t withdrawal s fro mthe market , withou t an

yidentifie d environmenta l benefit .

W e believ e EP

Amus t asses s th e objective s i n thi s rulemaking . I n contras t t o mos t EP Aregulation s wit hhig hpotentia l impact , EP Aha s no t included a complet e regulator yanalysi s o f thei r concern s an d possibl e options . T o focu s rulemaking o n issue s o f rea l concern , EP A shoul d conduc t a thoroug hregulator

yanalysis . Thi s regulator y analysi s shoul d evaluat e whethe r combination s wit ha fue l cause s advers e environmenta l o r healt heffects . I t shoul d addres s whethe r exposur e t o liqui d fuel s o r evaporativ e emission s ar e a concern whic h i s no t being addresse d b ycurren t EP

Ao r OSH

Aregulations . Th e regulator

yanalysi s shoul d asses s existing informatio n on fue l additive s t o determin e i f ther e i s sufficien t reaso n t o believ e tha t registere d additive s adversel yaffec t combustio n emissions . Th e analysi s shoul d determin e howtesting dat a woul d b e use d in Sec . 211(c ) regulator

yactions .

V . Th e Clea nAi r Ac t Amendment s shoul dals o be considere di n relationshi pt o thi s issue .P.1 1 Pag e 9 Finally , th e analysi s shoul d examin e howthe propose d regulation s relat e t o the 199 0 Clean Ai r Ac t Amendment s whic hpotentiall ywil l resul t i n fundamenta l change s in vehicl e fuels . Althoug hSec . 211(b ) an d (e ) provision s ar e no t change d i n eithe r the Senat e o r Hous e bills , ther e ar e othe r propose d amendment s whic har e relevan t t o the ANPRM . I n particular , bot hbill s actuall yrequir e the us e o f fue l additive s t o preven t the formatio n o f deposit s i n fue l systems . I n addition , CM A believe s tha t fue l additive s wil l b e a crucia l par t o f the "clean fuels " approac ht o reducin g combustio n emissions . Finally , the 199 0 propose d Amendment s woul d furthe r limi t evaporativ e emission s during refueling an

d fro mvehicles . Becaus e thi s wil l reduc e human an d environmenta l exposure , w e believ e thi s shoul d b e considere d b yEP Ai n th e rulemaking i n assessing whethe r ther e i s a nee d fo r testing o f liqui d fuel s an

d fue l additives .

VI . EP A shoul dconsider ho w toxicit

y dat a woul db

e usefu l t o th

e Agenc y i ncarryin

g ou t it s responsibilitie s under th e Clea nAi r Act .
Thi s lead s t o anothe r importan t issu e whic hneed s t o b e addresse d regardin

g th e us e o f toxicit ytesting dat a whic hwoul d b e generate d a s a resul t o f the rul e develope d fro mthe ANPRM . EP

Ashoul d carefull y conside r ho

w toxicit ydat a generate d b yfue l an

d additiv e manufacturer s woul d b e usefu l t o the EP A in carrying ou t thei r responsibilitie s unde r th e Clean Ai r Act . Th e ANPR M propose s broad testin g o f fue l an

d fue l additiv e products , ye t Sec . 211(c ) o f th e Clean Ai r Ac t explicitl yP.1 2 Pag e 1 0
authorize s EP

At o regulat e fue l additive s onl yo n the basi s o f the advers e effect s o f emissions . Thi s i s supporte d b ylegislative histor y containe d i n the EP Adocke t whic hsummarize s wha t became the 197 7 Sec . 211(e ) provision :
"First , testing coul d b e require

dt o determin

e th e healt h effect s o f emissio n product s o f fuel s o r fue l additives. "
Sinc e EP

Alack s regulator

yauthorit yt o regulat e on th e basi s o f non-emission s base d effects , i t woul d mak e littl e sens e t o requir e testing t o evaluat e thes e potentia l effects . W e believ e EP Ashoul d avoi d testing fo r the sak e o f testing .

I n thi s regard , w e believ e tha t th e toxicit yo f chemica l component s containe d i n fuel s an d fue l additive s ar e alread yadequatel y addresse d b

yth e Toxi c Substance s Contro l Ac t (TSCA) . "New " fue l additiv e chemical s introduce d sinc e 197 8 hav e al l b e subjec t t o EP A reviewan

d hazard assessmen t a s par t o f th e Premanufacturing Notificatio n (PMN ) process . I n 1988 , th e EP AOffic e o f Toxi c Substance s institute d newinterna l guideline s fo r th e reviewo f chemical s wit hhig

hproductio n volumes , an d potentiall ylarg e worke r an d consume r exposures . W e believ e virtuall yal l newfuel s additive s (excep t polymers ) woul d mee t thes e newTSC Acriteri a fo r "hig h exposure " chemicals . A s such , the yar e subjec t t o intens e EP ATSC A Sec . 5(e ) Consen t Orders .P.1 3 Pag e 1 1
"Existing " fue l additiv e chemical s are , o f course , subjec t t o potentia l regulatio n an d testin g unde r Sectio n 4 o f TSCA . I n fact , EP A ha s alread yexercise d thi s authority . Ther e i s currentl ya ver ylarg e scal e testin g progra mfo r methy l tertiar ybuty l ethe r (MTBE) , whic h i s use d primaril yi n fuels .

VII . Atiere d matri x approac hma yoffe r a focuse d proces s t o identif yemission s toxicit ytestin g needs .
Whil e w e urg e EP At o re-evaluat e thei r objective s an d focu s o n th e ke yenvironmenta l issues , w e als o believ e tha t som e o f th e concept s identifie d i n th e ANPR M meri t furthe r consideration . W e believ e tha t th e tiere d matri x approac hma yoffe r a potentiall yflexible , focuse d proces s t o identif yfue l an d fue l additiv e combination s fo r whic h furthe r emission s toxicit ytestin g ma yb e needed . However , w e fee l tha t th e matrice s identifie d i n th e ANPR M ar e no t optimall ystructure d fo r decision-making , becaus e toxicit ytestin g i s require d befor e ther e ha s bee n sufficien t analysi s an d judgmen t exercise d t o determin e whethe r thi s testin g i s reall ynecessary , o r woul d eve n b e usefu l i n achievin g regulator yobjectives .

VIII . Potentia l exposur e need s t o b e a majo r facto r i n th e ris k

equation .

Th e ANPR M note s tha t Congress ' approac hwa s t o mandat e a ris k assessmen t fo r potentia l advers e effect s health , welfare , an d emissio n contro l systems . I t state s (t o quote) :P.1 4 Pag e 1 2

"Sinc e ris k i s a functio n o f exposur e an d toxicity , on e ke ytene t o f th e progra

m wil l b e t o asses s potentia l ris k usin g thes e factors . "

W e strongl ysuppor t thi s approach . However , w e questio n whethe r th e proposa l t o us e "productio n volume " a s a facto r i s valid . Mos t importantly , w e fee l tha t th e ANPR M doe s no t sufficientl yconside r potentia l exposur e a s a majo r facto r i n thi s ris k equation . A s wit h manychemicals , ver ylowexposur e potentia l ma ynegat e th e nee d fo r toxicit ytestin g i f ther e i s sufficien t information , includin g fo r exampl e "structure-activit yrelationship " (SAR ) data , t o asses s a combustio n emission' s approximat e toxicity . However , w e d o believ e tha t a matrixe d tiere d approac hi s probabl yth e bes t mechanis mfo r identifyin g testin g needs .

IX . The "generall y similar " definitio nshoul db e carrie dforwar dint o thi s propose d rule .

Th e additive s manufacturer s suppor t linkin g thes e propose d regulation s t o existin g fue l additiv e registratio n procedure s base d upo nth e "generall y similar " definitio n fo r fue l additives . W e believ e tha t the "generall y similar " provision s o f th e curren t registratio n provid e a workabl e mechanis mfo r reviewin g an d registerin g fue l additives . W e thin k tha t th e "generall ysimilar " provisio n i s sufficien t i n considerin g combustio n emission s whic hi s th e mos t importan t healt h an d environmenta l concern.P.1 5

It « • Pag e 1 3

X . Conclusion s

We believe EPA

ca nsuccee dinthi s comple xrulemakin g i f i t follow s the statutory mandat e whic hrequire s judgment , discretio nan da focuse dapproac honpotentia l healt han denvironmenta l concerns . Th e ANPR M identifie da wid e spectru m o f issues , bu t we woul dhop e tha t EP A no w intend s t o focu s it s effort s t o develo ptestin g regulation s whic h addres s rea l concerns , an dwhic har e consisten t wit hEPA' s regulatory power s unde r Sec . 211(c) . An y regulatio nwhic hindiscriminatel y require s broa dtestin g withou t regar dt o actua l environmenta l issue s o r concern s run s th e dange r o f causin g needles s disruptio nan deconomi c hardshi po

nproducer s an

dconsumer s o f fuel s an dfue l additives . A s I pointe dou t a t th e beginnin g o f thi s presentation , we believe , an d Congres s apparentl y concurs , tha t fue l additive s ar e par t o f th e solution , no t th e problem . We fee l th e regulation s shoul dreflec t thi s fac t andEPA

shoul dno t jeopardiz e futur e fue l additiv e innovation s whic hwil l benefi t th e environment , an dwhic hwil l be necessar y for th e succes s o f th e "clea nfuels " requirements .

Th e CM A Petroleu

m Additive s Pane l woul dlik e t o offe r EPA ou r assistanc e i nprovidin g technica l informatio nindiscussin g regulatory options . W e believ e we coul dprovid e mor e usefu l informatio ni f we were give n6 0 day s inwhic ht o comment . We woul dlik e t o reques t tha t EP A extendth e perio dfor submissio no f writte ncomment s t o thi s docket .

Than k yo ufor thi s opportunit y t o presen t ou r views , an dwe hope tha t w e ca ncontinu e t o wor kwit hEPA t o achiev e a productive outcome .