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# OAR Box 1846 Prepped by Ollie Stewart



### Document

Number: 

# 57 ) ll-H- 5 Docket Number: 

# A-90-0 7

Printed 11/18/20087:30:16

AM Sheet 57 of 93L . J UNITE D STATE S O F AMERIC A ENVIRONMENTAL PROTECTION AGENC Y P. 2

A-90-O- 7

I N TH E MATTEROF : Fuel s an

d Fue l Additive s Registratio n Advanc e Notic e o f Propose d Rulemakin g ) EP A Ai r Docke t ) Docke t #A-90-0 7

. )

Publi c Hearin g o f th e Environmenta l Protectio nAgenc y i n the above-entitle d matter , hel d a t Domino' s Farms , An nArbor , Michigan , o

nWednesday , Septembe r 26 , 1990 .

APPEARANCES : 

## otf* 0 

## ' .<*$

CHARLE S GRA

Y Director , Emissio nContro l Technology Divisio n GLEN PASSAVANT Senio r Projec t Manager , Standard s Developmen t an d Suppor t Branc h CAROLY N KRUEGE R Standard s Developmen t an d Suppor t Branc h MARGARE T GILHOOLE Y Offic e o f Genera l Counse l HEID I SIEGELBAU

M Offic e o f Toxi c Substance s JUDYGRAHA

M Offic e o f Researc han d Developmen t

Wester nWayn e Cour t Reportin g Servic e

Plymouth , Michiga n Susa nBeale , Reporte rP. 3



### INDE X

Introduction : CHARLE S GRA

Y

D u Pon t Company : DAVI D ZIMMERMA

N Discussio n
America n Petroleu

mInstitute : RICHARD CAVALL I Discussio n

Moto r Vehicle s Manufacturer s Association : MARCE L HALBERSTAD T Discussio n
Chemica l Manufacturer s Association : CHARLE S KELLE R Discussio n Page :

3

1 2 1 8

3 9 4 9

6 9 7 3

7 9 9 3

2P. 4

• " 1 L . J An nArbor , Michiga n Wednesday , Septembe r 26 , 199 0 MR . GRAY : First , I wan t t o welcome yo u t o thi s Publi c Hearin g onfuel s an d fue l additive s registratio nregulation s tha t we propose d i nthe Advanc e Notic e o f Publi c Rulemaking . Dic k Wilson , wh o wa s schedule d t o be th e presidin g office r thi s morning , coul d no t mak e it . M y nam e i s Charle s Gray , an dI wil l

serv e a s the presidin g offic e fo r today' s hearing . Also , o

nthe pane l wit hm e today

ar e Gle nPassavant , a t th e fa r end ; Caroly nKruege r o f th e Emissio nContro l Technology

Divisio no f EPA' s Mobil e Sourc e Program ; Margare t Gilhoole y fro m ou r Offic e o f Genera l Counsel ; t o Carolyn' s right , thre e dow nfro m me , Heid i Siegelbau m fro m ou r Offic e o f Toxi c Substances , nex t t o th e las t o n the end ; an

d Jud y Graha m fro m ou r Offic e o f Researc han d Development . Becaus e o f th e natur e o f thi s regulation , i t cross-cut s a lo t o f differen t progra m activitie s withi nth e Agency , we fee l rea l fortunat e t o hav e a ver

y good representatio no f differen t office s today o nou r program . Usuall y ou r rulemaking s ar e fairl y specific , an

d generall y

th e Offic e o f Mobil e Source s an

d usuall y

th e Offic e o f Genera l Counse l serve

3P. 5

1— 1 L J onthe panel . So , thi s rulemakin g i s a very comple x rulemaking , an

d we'r e fortunat e t o have suc ha good representation . Also , Kar l Mazz a fro m ou r Assistan t Administrator s Offic e wa s schedule d t o be here , bu t als o couldn' t mak e it .

Th e purpos e o f today' s hearing i s t o accep t publi c testimon y and/o r commen t o nthe Augus t 7 Federa l Registe r Advanc e Notic e concernin g registratio n regulation s fo r fuel s an d fue l additive s unde r Clea nAi r Ac t Sectio n211(b)(2) .

The statutory

authorit y

fo r suc h regulation s i s containe d i nClea nAi r Ac t Section s 211(a) , 211(b) , an d 211(e) . A s yo

u ma y know , Sectio n 21 1 (b)(2 ) ha s neve r bee nimplemente d i nspit e o f th e requiremen t statin g th e regulation s implementin g th e Sectio nwer e t o b e i nplac e withi non e yea r o f enactmen t
o f the 197 7 Clea nAi r Ac t Amendments . Althoug ha n Advanc e Notic e o f Propose d Rulemakin g wa s publishe din 1978 , the rul e wa s no t completed . A s a resul t o f a lawsui t i

nlat e summe r o f 1989 , we ar e no w workin g unde r
a court-ordere d schedul e b y whic hth e rulemakin g i s t o be implemented . I t call s fo r a Notic e o f Propose d Rulemakin g t o b

e signe d no late r tha nJanuary 1 , 199 2

an d a Fina l Rul e signe d no late r tha nJun e 1 , 1993 .

4P. 6

1

— ! i i Currently , fuel s an d additive s ar e require d t o be registered , an d producer s mus t confor m t o certai nrequirement s i norde r t o d o so . Thes e require ment s ar e foun

d i n4 0 CFRPar t 7 an d consis t o f providin g certai ninformatio no nthe fue l o r additiv e
suc ha s chemica l composition , percen t used i nthe fuel , an d purpose-in-use . Thes e requirement s ar e th e resul t
o f implementatio no f Sectio n211(a ) an d 211(b)(1 ) o f the Clea nAi r Act . Implementin g th e 211(b)(2 ) testin g progra m wil l ad

d health , welfare , an d emissio ncontro l syste m effect s informatio nt o th e registratio nprocess .

Ther e ar e thre e mai narea s thes e regulation s mus t address : healt heffects , emissio n contro l syste

m effects , an

d welfar e impacts . Fo r eac h

o f thes e areas , fuel s an d additive s wil l hav e t o b e evaluate d fo r thei r effects . Fo r thos e fuel s an d additive s registere d a t th e tim e the regulation s ar e promulgated , tha t have alread y bee nregistered , thi s evaluatio nperio d cancove r u p t o thre e years . Fo r thos e fuel s an

d additive s no t registere d a t the tim e o f th e promulgatio no f the fina l rules , thes e effect s mus t be determine d prio r t o registration .

Indeterminin g th e effect s o f fuel s an d additive s onhealth , emissio ncontro l systems , an dP. 7

welfare , w

e have suggeste d a tiere d approac hi nthe Advance d Notic e whereb y increasing level s o f require ment s woul d be organize d int o fou r tiers . Th e firs t tie r woul d involve a compariso nt o those , i f any , fuel s
o r additive s fo r whic hi t had beendetermine d tha t sufficien t informatio ni s alread y available . Suc hfuel s
o r additive s woul d b e labele d "base " fuels/additives . Tie r 2 the nwoul d requir e a literatur e searc han d submitta l o f availabl e informatio nonth e variou s effect s o f concern . Tier s 3 an d 4 woul d involv e increasingl y

sophisticate d testin g requirement s i f adequat e informatio nwa s no t submitte d o r i f th e submitte d informatio nindicate d a possibl e unreasonabl e risk . Afte r eac htier , onc e adequat e dat a wer e collecte d an

d i t wa s determine d tha t th e fue l o r additiv e i

nquestio ndi d no t pos e a nunacceptabl e hazard , the nth e fue l o r additiv e inquestio nwoul d represen t a "base " fue l o r additive , an d registratio n woul d be granted .

Again , a simila r tiere d approac hi s als o being considere d fo r assessin g emissio ncontro l syste m
an d welfar e effects .

Ther e ar e man

y difficul t issue s involve d wit hdevelopin g a progra m whic himplement s th e Clea nAi rP. 8



# ~ l J Ac t requirement , ye t doe s no t represen t a nunnecessar y burde nuponproducer s o r EP A t o carry

i t out . We hav e identifie d an

d discusse d man

y o f thes e issue s i nthe Advanc e Notic e o f Propose d Rulemakin g an d as k fo r your detaile d inpu t i

nthes e areas . Inaddition , we have lai d ou t a numbe r o f technica l question s i nthe Advance d Notic e whic hwe hop e yo u wil l tak e tim

e t o addres s i

n you r writte ncomments . Wit hth e rulemakin g bein g conducte d unde r a restricte d schedule , your comment s an d suggestion s wil l receiv e th e greates t consideratio ni f receive d earl y

i nth e process . We conside r you r input s
an d viewpoint s extremel y importan t a s we ente r int o the developmen t o f thi s proposal . Thi s i s a very comple x rulemaking , bu t ou r restricte d schedul e doe s no t allo w fo r a grea t dea l o f tim e fo r follow-o ndiscussion s an d meetings , Ther e i s a sign-i nshee t fo r attendanc e inth e lobb

y wher e you came in . Hopefull y al l o f yo

u hav e signe d in . I f yo u hav e no t don e so , we woul d reques t tha t yo

u d o tha t a t your convenience . A separat e shee t fo r presentin g testimon

y wa s als o availabl e a t th e tabl e i nth e lobby , an d thos e o f yo

u testifyin g hopefull y hav e alread

y contacte d Caroly

nan d ar e signe d i

na t th e lobby . WeP. 9

1 1 l

_J actuall y have , I think , fou r differen t organization s tha t ar e signe d u p t o testify , i f you'r e no t onthe lis t an d wis ht o testify , w e woul d appreciat e i t i f yo u woul d le t u s kno

w a s soona s possibl e s o tha t we ca n anticipat e ou r schedul e an d wor k you in . Ou r plani s t o receiv e testimon y i nth e orde r o f the sign-up sheet . I f th e audienc e ha s an y questions , we reques t tha t yo u writ e the question s dow n
o na piec e o f pape r an d the npas s i t alon g t o on e o f th e member s o

nthe panel .

Th e hearin g wil l continu e throughou t the da y o r a t leas t unti l al l th e comment s hav e bee nmade . I f necessary , w

e wil l brea k fo r luncha t a convenien t tim e and , i f necessary , finis hth e hearin g thi s after noon . A s yo

u ma y have notice d onyour way int o th e conferenc e room , ther e i s a smal l snac k ba r jus t outsid e th e entrance , an

d yo u canpurchas e snack s o r beverages . It' s probabl y

prett y

obvious , bu t I gues s othe r option s involve th e Domino' s Pizz a Stor e locate d nearby . There' s a full-siz e cafeteria , pettin g far m an dsome othe r thing s around here . I f w e brea k early , some o f you ma y wan t t o tak e a loo k around . It' s a ninterestin g plac e actually . I'v e no t had a chanc e t o se e i t myself , bu t i t i s a

ninterestin g complex , jus t t o fin dyou r wa

y


### 8P.1 0

here . I gues s map s ar e availabl e i nthe informatio n lobby , i f an

y o f yo u reall y

ar e intereste d i nthat . Th e writte ncommen t period end s 3 0 day s fro m thi s hearing , o r Octobe r 26 . Writte ncomment s shoul d be addresse d t o the Publi c Docke t Numbe r A-90-0 7

a t EPA' s Ai r Progra m Docket . I t woul d als o b e helpfu l i f a cop

y coul d be forwarde d t o An nArbor , t o the attentio no f Caroly nKrueger . Befor e w

e begi ntoday , le t m e as k i f ther e ar e an

y question s fro

m th e audienc e regardin g ou r plan s fo r today' s events ? I f not , le t m e g o ove r the lis t o f organization s tha t have indicate d interes t i n presentin g a statemen t t o us . Th e firs t i s D uPont ; the
second woul d be th e America nPetroleu m Institute ; third woul d b

e th e Moto r Vehicl e Manufacturer s Association ;
an d the fourt hwoul d be CMA/Exxo nChemical . So , i f your
nam e i s no t onthi s lis t an d yo u woul d lik e t o mak e a statement , le t u s kno w a s quickl y

a s possible . A s wa s state d i

nth e openin g statement ,
w e d o acknowledg e tha t thi s i s a comple xrulemaking . It' s clos e t o 1 3 year s afte r th e requiremen t wa s institute d a s par t o f the Clea nAi r Ac t Amendment s o f 1977 . We hav e had activit y earlie r throug hth e issuanc e
o f th e Advanc e Notic e sometime back . W e receive d aP.1 1

grea t amoun t o f commen t o nthe wa

y we shoul d procee d wit hthe proces s o f implementing thes e regulations .

Th e potentia l fo r economi c burde ni s
ver y larg e here , bu t the subjec t matte r i s ver y crucia l

a s well . Wit hth e advanc e i nthe energy

sector , moto r fue l sector , a s unsettle d a s the y ar e a t thi s poin t i n time , I think it' s likel y t o se e renewe d interes t i n settin g i

nplac e a framewor k fo r evaluatin g futur e ne w fuel s o r fue l modification s o r additives .

So , w e d o sincerel y

hop e tha t youwil l participat e wit hu s inputtin g togethe r th e bes t possible , i

nterm s o f effective , an d ye t a proposa l tha t woul d minimiz e the burde no f implementin g i t onbot hthe Agenc y an d th e affecte d parties . Thi s i s th e stag e wher e you r inpu t canbe mos t usefu l t o us . We woul d

eve nbe intereste d i nidea s abou t ho

w we shoul dcontinu e th e proces s o f receiving input . We d o hav e a quarterl y schedule , an

d we wil l need t o be issuing ou r Notic e o f Propose d Rulemakin g onschedule . Fo r thos e o f yo u familia r wit hou r process , tha t mean s tha t we wil l reall y hav e t o be draftin g ou r Notic e probabl y eve n withi nthi s upcomin g yea r t o be abl e t o coordinat e such

a complicate d proposa l throughth e Agenc y an d othe r agencie s tha t wil l be interested . 

### 10P.1 2



### So , eve n thoug

h i t seem s lik e a littl e longe r schedul e than oftentime s ou r regulation s represent , becaus e o f it s natur e w e hop e tha t yo u wil l be abl e t o giv e providing inpu t a t thi s stag e a ver y hig h priorit ybecaus e w e ar e lookin g fo r constructiv e input . W e hop e tha t you wil l wor k wit h u s during thi s phas e s o tha t th e Notic e o f Propose d Rulemaking ca n be
a s clos e t o th e characte r o f th e fina l rulemaking a s w e
can mak e it . Again , thos e o f yo u tha t hav e participate d in EP

Arulemaking s knowtha t i t become s somewha t mor e complicate d t o interjec t majo r change s afte r a forma l proposa l becaus e othe r partie s nee d t o hav e a n opportunit yt o reac t t o majo r change s afte r the proposal . So , again , I jus t wan t t o stres s th e importanc e o f beginning t o wor k wit h u s a t thi s time . We' d hope d fo r a lo t mor e peopl e participating in thi s hearing . I' msomewha t disappointed , mayb e becaus e agai n th e schedule , tha t mor e peopl e hav e no t show n up , bu t
nowi s th e bes t time t o be working wit h us , an d w e ar e quit e receptive . W e d o appreciat e thos e o f you tha t ar e presenting testimony , an d look forward t o a constructiv e hearing . I f there' s nothing els e fromth e


### 1 1P.1 3

I 1 L J audience , no question s o f an y type , I think we canas k D u Pon t t o com

e forwar d an

d begin . Ther e i s someon e her e fro

m D u Pont , Davi d Zimmerman . MR . ZIMMERMAN : Good morning , m y nam e i s Davi d Zimmerman . I' m Produc t Manage r fo r Petroleu m Additive s wit hth e D u Pon t Company , Wilmington , Delaware . We welcome thi s opportunit y t o commen t
o nth e ANP Rregardin g Fuel s an d Fue l Additive s Registration . We realiz e tha t the EP A ha s a mammot h undertakin g ahea d o f i t i ndealin g wit hthi s issue . A s state d i

nth e Notic e fo r thi s meeting , ther e ar e man y comple xissues , man y fuel s an

d a multitud e o f additive s involved . Obviously , th e EP A need s a s muc hwel l though t but , soun

d inpu t a s possibl e fro m industry , technica l groups , an

d othe r intereste d partie s i norde r t o conclud e thi s matte r t o th e mutua l satisfactio no f al l involved , hopefully , a s you state , withou t causin g th e result s t o be undul y burdensome an

d stil l resultin g i na progra m tha t i s reasonabl e an d necessary . Jus t a s th e EP

A ha s a majo r undertakin g befor e it , we , wh o woul d lik e t o provid e inpu t inth e for m o f writte ncomments , als o fac e a monumenta l tas k i n attemptin g t o respon d t o th e man

y question s an

dissue s


### 12P.1 4

raise d i

nthe Advanc e Notice . It' s realize d tha t thes e comments , t o b

e significant , mus t b e comprehensiv e an d wit ha s muc hdocumentatio na s w e canpossibl y

give you . Fo r thi s reasonwe woul d firs t of f respectfull y reques t that , i f possible , withi nyou r tim e constraints , tha t th e deadlin e fo r writte ncomment s be extende d b y anothe r 6 0 day s t o Decembe r 24 .

Althoug hw

e canprovid e muc hmor e inpu t i f th e perio d fo r writte ncomment s i s expanded , ther e
ar e tw o issue s we woul d lik e t o discus s a t thi s time . Th e firs t i s the issue o f Smal l Busines s Provisions .

W e do no t feel , fo r fue l additive s a t least , tha t a cas e canproperl y be mad e fo r th e exclusio nfro

m th e progra

m o f an y compan

y o r it s product s base d uponrevenues . Instead , we fee l tha t an y progra m o f thi s typ e shoul d be base d solel y uponth e us e volume and/o r potentia l ris k o f th e produc t involved .

Whil e we think , an d we believ e th e industry

think s tha t th e D u Pon t Petroleu

m Additive s busines s i s a substantia l facto r i nthe marketplace, i t i s conceivabl e tha t ou r tota l annua l sale s o f thos e product s specificall y fallin g unde r th e propose d requirement s ar e les s tha nth e EP A suggeste d smal l volume trigge r o f 4 0 million . Thi s i s a nextremel y


### 1

3P.1 5

fragmente d industry , mad e u p o f man

y smal l components , some.independent , an d other s owne d b

y larg e corpora tions . T o exclud e fro m an y propose d requirement s thos e companie s whos e sale s ar e belo w a certai nfigur e woul d penaliz e thos e businesse s owne d b y a large r corporation . An y argumen t tha t the large r corpora tion s canaffor d the propose d burden s bette r tha nthe smalle r companie s i s false . Th e businesse s withi na large r corporatio nmus t g o t o thei r management , jus t a s th e smalle r companie s mus t g o t o thei r bankers , fo r the capita l necessar y

t o kee p th e busines s health y an dt o expand uponit . Unfortunately , thi s i s a nindustry

wit h

very smal l profi t margins . I f cost s ar e no t born e equall y

b y al l participants , management s o f th e large r corporation s wil l be hesitan t t o continu e t o inves t neede d capita l inbusinesse s i nwhic hthey

hav e a non competitiv e position . This , intime , coul d reduc e competitiv e activit y b y causin g the companie s burdene d b y testin g t o leave th e busines s t o th e smalle r firms , who woul d the nbe exempte d fro m th e program , thu s defeatin g it s purpose .

Also , large r corporat e businesse s ten d t o hav e a large r produc t line . Th e numbe r o f currentl y activ e D

u Pon t Petroleu

m Additive s potentiall y fallin g


### 14P.1 6

L . J unde r the propose d regulation s i s approximatel y 125 . Whil e man

y o f thes e products ' annua l volume s ar e insignificant , the y coul d be include d i nth e progra

m becaus e o f th e manufacturer' s tota l revenue s fro m al l businesses . At th e sam e time , a smaller , privat e corporatio nwit honl y a fe w product s i

nthe line coul d have individua l produc t volume s manyfol d greater , ye t b e exclude d fro

m th e program . This , again , seem s contrary t o the inten t o f th e program , bot hi nth e assessmen t o f th e ris k an

d the desir e t o avoi d unnecessar y testin g an

d registratio nevaluatio nburden .

Therefore , shoul d i t becom e necessar y

t o propos e regulation s fo r th e testin g o f fue l additives ,
we woul d propos e tha t suc hrule s appl y t o al l manufacturer s equally .

Yo u wil l not e tha t I jus t said , "shoul d i t becom

e necessar y

t o propos e regulation s fo r th e testin g o f fue l additives. " Thi s lead s m e int o th e
second are a we woul d lik e t o discus s today , tha t o f whic hfue l additives , i f any , need t o b e teste dfo r huma nhealt han

d environmenta l effects . Mos t fue l additive s ar e sol d vi a dru m o r tank truc k fo r us e inrefinerie s or , insome cases , oi l compan y produc t terminals . Th e additio nproces s i s


### 1 5P.1 7

conducte d b

y well-trained , industria l personnel , an dthe additive s ar e alread y wel l dilute d t o level s o f tw o t o 65 0 part s pe r millio nbefor e the y reac hth e consumer . Thus , exposur e potentia l i s minimal . Additionally , i n
mos t case s th e significan t hazard s presente d b y the additive s ar e thos e whic hcanbe attribute d t o the solvent s used a s carrier s o r diluents . Thes e solvents , sinc e they

ar e al l commonpetroleum-base d materials , ar e alread y well-know

nt o th e petroleu m industry

personne l handlin g them , an d wel l documente d a s t o healt hhazard s
an d ar e generall y

no mor e hazardou s tha nth e fuel s int o whic hthey

ar e being introduced . We fee l tha t th e lo w exposur e potentia l o f thes e product s a s they ar e normall y

handled , couple d wit hthei r relativel y lo w healt hhazards , present s a ris k t o huma nhealt han d environmen t belo

w tha t whic hwoul d justif y additiona l testin g an

d evaluatio nunde r a reasonabl e an d necessar y program . Furthe r quantificatio no f th e exposur e potentia l canb

e provide d throughwritte ncomments . A s fo r th e emissio neffect s o f petroleu m additives , we cancom e u p wit ha

nargumen t whic ha t firs t glanc e seem s contradictory , tha t mos t additive s
use d insmal l concentration s hav e a positiv e effec t o n the effor t t o improve ou r ai r quality , ye t ar e o f no


### 1 6P.1 8

L . J impac t b y an d o f themselve s o ntha t ai r quality . T o explai nfurther , additive s ar e used t o improve th e qualit y

o f th e fuel s o r the performanc e o f the engine s i nwhic hthe

y ar e consumed . B y th e preventio no f deterioratio no f fue l qualit y an d th e proces s o f keeping th e component s o f th e engin e clea nan d performin g a s designed , thes e additive s ar e beneficia l t o th e effor t t o improve the ai r qualit y aroun d us . At the sam e time , th e combustio nproduct s o f thes e additive s ar e negligible , being fo r th e mos t par t wate r vapo r an d carbo ndioxide . Thi s argumen t i s no t contradictor y whe n
on e realize s tha t the cas e fo r beneficia l effect s upon th e environmen t i s du e t o the actio no f th e additiv e i n questio nuponthe fue l inwhic hi t i s used , whil e b y themselves , th e combustio nproduct s o f anadditiv e ar e minima l whe ncompare d t o tha t o f the fuel .

A s a nexampl e o f thi s latte r point , I hav e on e chart . Wha t we'r e showin g her e i s fro m typica l additive s used i

ngasoline , moto r fuels , an d i ndiese l fuels , a t thei r trea t levels , thei r contributio nt o exhaust . A s you ca nsee , th e produc t currentl y use di

n th e highes t dosage , th e intak e valv e detergen t additive , stil l ha s a several-fol d facto r differenc e betwee nit s contributio nt o the ultimat e emission s an d tha t o f the



### 17P.1 9

I 1 U J fuel . Give nthe statement s alread y made , w

e would , therefore , propos e that , a s a firs t screen , additive s comprise d o f onl y carbon , hydrogen , nitrogen , an d oxygen , an

d used i

nconcentration s les s thanone tent hpercen t weight/volume i nfuel s be exempte dfro m furthe r evaluatio nunde r thi s propose d rulemaking .

We ar e gratefu l fo r the opportunit y t o presen t ou r inpu t t o thi s massiv e undertakin g b y th e EPA . We pla nt o expand uponth e comment s alread y presented , a s wel l a s discus s additiona l area s o f

concer nfo r whic hyou'v e requeste d comment s ina writte n submission . Again , i norde r t o addres s thes e issue s a s wel l a s possible , we reiterat e ou r reques t tha t th e EP A extend th e commen t perio d t o Decembe r 24 , 1990 ; thank you . MR . GRAY : Yo u see m t o generall y

be suggestin g a concep t where , eithe r becaus e o f very lo w volume s o r becaus e o f th e chemica l compositio nbeing simila r to , perhap s othe r organics , organic-derive d compound s being marketed , tha t tha t shoul d be sor t o f a framewor k fo r whic ht o a t leas t exclud e a larg e numbe r
o f materials , an

d the nconcentrat e onth e remainin g one s wit hrespec t t o testin g programs . Yo u didn' t reall y


### 18P.2 0



### elaborat e on wha t th e procedur e migh t be , beyon d your recommendatio n t o scree n compound s tha t hav e onl y hydrogen , oxygen , carbon , an d hydrogen , I think . MR . ZIMMERMAN : Yes , I thin k w e can reduc e th e burde n on al l o f u s b yhaving a firs t cu t tha t reduce s o r eliminate s fro mth e progra

mthos e tha t
ar e essentiall ybasic , organi c materials , again , ver y simila r t o th e fuel s in whic h they'r e alread ybein g put , a t lo wtrea t level s unde r closel ycontrolle d additio n conditions , an

d the n appl ythe bul k o f the effor t o n othe r product s whic h ar e potentiall ydangerou s t o the catalyti c converte r o r whic h w e knowo r suspec t hav e seriou s healt h o r environmenta l consequences .

MR . GRAY : D o yo u se e thi s ide a a s bein g simila r t o wha t w e suggeste d in th e ANPRM ?

MR . ZIMMERMAN : Similar , bu t no t quit e th e same , I don' t think .

MR . GRAY : Howd o you se e i t differing ? I t seem s s o similar , I' mhaving a hard time .

MR . ZIMMERMAN : Well , a s I rea d th e ANPRM , you'r e proposing , a s your firs t tier , dat a fro m lik e chemistry . I gues s mayb e thi s i s th e same , bu t i t i s a differenc e in wha t you propos e a s lik e chemistry . I wa s thinking o f lik e chemistrya s a chemica l clas s o f

1 9P.2 1



## ^ 1 L.. J compounds . Wha t I' m proposin g i s a t leas t a s a ninitia l cut , lik e chemistr y b e close r t o tha t whic hwa s originall y

considered , wha t wa s tha t ter m — sub stantiall y

similar , rathe r thanchemica l classe s themselves , bu t a noveral l grouping . MR . GRAY : Well , I think w e usedth e phrase , bas e fue l o r bas e fue l additive , an d the neve n fo r those , say , mor e commonmaterials , we stil l rea dthe statut e a s requirin g u s t o have a nobligatio nt o insur e tha t there' s sufficien t publi c healt hinformatio n availabl e oneve nthos e materials . A t som e poin t w

e probabl y

need t o b

e involve d i

ndiscussin g whethe r we hav e enoughinformation , eve nthe mos t basic , wit hfuel s
an d fue l additives , t o fin d out , fo r example , i f there' s
an y possibilit y

o f establishin g unde r thi s statut e an y material s a s bas e material s earl y i nthe process , whic h i s i neffec t wha t you'r e suggesting , I think , probabl y the broades t definitio no f th e mos t commonmakeu po f fuel s an

d fue l additive s an d suggestin g o r seein g tha t

we have enoughinformatio navailabl e ontha t broa dclas s
o f compounds . Ther e ar e around fou r element s involved , bu t ther e canb

e a larg e numbe r o f compounds , an ds o w e think probabl y

w e need t o have some mor e discussio n abou t whethe r o r no t that' s to o broad o f a grouping , yo u



### 2 0P.2 2

L J 

### know , fo r u s t o be abl e t o satisf you r responsibilities . But , followu

p in tha t regar

d t o hel p u s bette r understan

d howmayb e w e can wor k th e proces s o f having a broad category , bu t having confidenc e tha t al l th e possibl e compound s unde r tha t categorization , w e can hav e reasonabl e confidenc e w e hav e al l th e informatio n
w e need . That' s wher e we'r e seeing th e rea l difficult y in trying t o eve n pu t togethe r th e concep t o f th e Advanc e Notice , becaus e w e stil l hav e t o fee l tha t thi s bas e fue l o r bas e fue l additive , tha t w e hav e sufficien t informatio n t o whateve r it s definitio n coul d encompas s in term s o f compounds .

Again , that' s th e rea l technical , firs t difficul t step o f sorting thi s al l out , bu t a t leas t i t strike s me tha t you r statemen t i s suggestiv e o f a n approac h lik e that . Certainl ya s w e ge t int o th e pro ces s more , w e nee d t o come t o some , hopefully , agreemen t tha t ther e i s a framewor k fo r a proces s tha t make s sens e broadly , an

d the n ge t int o th e nex t mos t difficul t step , whic h i s t o sor t tha t ou t in term s o f th e technica l detail s o f howt o frame it . S o I thin k w e look forwar d t o th e nex t leve l o f detai l fro myo u in tha t regard . Le t me as k i f ther e ar e an yothe r question s fro

manybod

yo n th e panel ?


### 2 1P.2 3

MS . SIEGELBAUM : I wa s curious , o npag e thre e o f you r testimony , you have a statemen t regarding th e exposur e potentia l fo r fue l additive s a s being minimal . At thi s tim e ha s D

u Pon t conducte d an y stat s
onthe long-term , chroni c effect s o f tha t exposure ?

MR . ZIMMERMAN : O f the chemical s themselves ?

yes ? MS . SIEGELBAUM : O r th e fue l additives ,

MR . ZIMMERMAN : I woul d the nhav e t o tur nt o m

y assistan t inth e audienc e here . MR . DASTUR : Th e ke y issu e her e i s on e
o f ris k assessment . Inris k assessmen t you hav e — I think wha t Dav e i s reiteratin g her e i s tha t fro m a n exposur e base d standpoin t ther e i s hardl y an y exposur e potential . Tha t i s wha t we ar e sayin g — (inaudible) . MS . SIEGELBAUM : Ar e you sayin g tha t there' s no exposure ?

MR . DASTUR : Yes , we'r e sayin g exposur e i s essentiall y

minima l an

d tha t a t th e level s tha t we'r e describin g ove r here , the y ar e o f muc hles s magnitud e tha nth e fuel s themselves .

MR . PASSAVANT : I migh t ad d tha t yo

u mad e th e presumptio ntha t w e hav e alread

y assume dtha t



### 2 2P.2 4

1 1 L . J th e fue l risk s ar e acceptable , an di f yo umak e tha t assumption , the nyou r argumen t follow s logically . Yo u mak e th e assumptio ni nyou r statemen t tha t w e accep t th e fue l risks , tha t we'v e alread y mad e tha t finding , an d then , therefore , yo uca nmak e thi s finding . That' s par t
o f wha t thi s rulemakin g i s about , i s t o mak e tha t finding .

t h e table , MR . GRAY : Pleas e us e th e microphon e a t

MR . DASTUR : M y

nam e i s Kavs y

Dastur . I' m wit hth e D uPon t Company . Th e essentia l poin t tha t we'r e makin g her e i s on e wher e wha t you'r e tryin g t o —
o r wha t w e thin kneed s t o b e don e i s tha t a ris k

assessmen t findin g need s t o b e made . Ther e ar e tw o component s t o that . There' s exposur e base dassessmen t
an da ris kbase dassessment .

Dave' s comment s essentiall y hav e been , o u r comment s hav e essentiall y bee naddresse dtoward s th e fue l additiv e issu e becaus e we'r e reall y no t i nth e fuel s business , bu t w e accep t th e poin t o f cours e tha t fro m a noveral l standpoint , yes , yo uhav e t o loo ka t bot hth e fue l a s wel l a s th e additive .

MR . ZIMMERMAN : I migh t add , i f I may , m y thought s i nputtin g thi s togethe r wa s no t tha t w e


### 2 3P.2 5

have accepte d the ris k o f th e fuels . M y feeling o

nthi s is , fo r instance , a corrosio ninhibito r presen t i nthe fue l o f thre e part s pe r million , an d whe nteste di

nthe fuel , it s presenc e i s s o minimal , an y effec t du e t o tha t corrosio ninhibitor , fo r instance , woul d be maske db y the man y effect s o f the fuel . I' m no t saying you'v e accepte d the fuel ; I' m jus t saying yo

u couldn' t fin

d the differenc e withi ntha t fuel .

MR . PASSAVANT : I recogniz e tha t eve n makin g tha t assessmen t ona combustio nbasi s woul dbe quit e difficul t becaus e o f the fac t tha t the fuel s themselve s coul d mas k th e result s o f th e smal l pp m additives . I jus t wan t t o say , I think tha t i s par t o f wha t the decision s ar e tha t need t o be mad e b y EP A ove r the cours e o f thi s ruling .

I wante d t o follo

w u p wit hanothe r questio nrelate d t o your concern s abou t smal l busines s impacts . Thi s i s on e o f th e area s tha t th e Ac t speak s to , i s tha t EP

A shoul d conside r it , bu t provide s u s almos t no guidanc e beyon d tha t i

nterm s o f sayin g wha t
ou r cut-poin t shoul d b e o r anythin g mor e thanjus t saying , conside r it . Wha t we trie d t o d o i nou r ANPR

M
wa s t o la

y ou t som

e ideas , a s she suggested , th e $4 0 million , bu t I think we als o cu t t o thi s poin t fairl y



### 2 4P.2 6

wel l whe nw

e bega ntalkin g abou t th e concep t o f groupings , i

nth e sens e o f sayin g tha t i f yo u fin d thre e
o r fou r differen t companies , mayb e som e small , mayb e
som e large , tha t mak e th e sam e basi c additiv e o r a highl y simila r additive , you woul d be puttin g the m i na positio nt o mak e the decisio nt o ac t a s a groupi n meetin g thes e requirement s o r t o ac t separatel y i n meetin g thes e requirements .

So , I wan t t o mak e m y poin t here , i s tha t we don' t necessaril y wan t t o be ina positio ntha t

w e exclud e an

y on e give nmanufacture r o r smal l produce r fro m requirements , bu t a t th e sam e tim e we'r e hopin g t o
se e i t being mor e o f a combine d effort , tha t the industry

pul l togethe r onthei r ow nt o d o this . I don' t think you'r e going t o fin d EP A ultimatel y

specifyin g tha t yo

u thre e o r fou r companie s wil l be groupe d togethe r t o d o thi s testing . Tha t wil l hav e t o b e a n industry

decision . Bu t we reall y think tha t ou r concep t
o f groupings , a s w e talke d abou t i

nthe Advanc e Notice , migh t ge t a t thi s mor e tha njus t fla t ou t exemption s o r exclusions . Al l I' m going t o sa

y jus t i

nclosing , I hop e tha t anyon e her e wil l addres s thi s poin t becaus e i t i s a very

difficul t one , withou t an y basi s i

nth e Act ,



### 2 5P.2 7



### t o cal l u s ont o specifi c requirements . Ou r option s ar e many , an

d the yd o hav e effects , a s you'r e pointing out , in term s o f differentia l effect s acros s businesse s an d such , an

d s o we' d reall ylik e t o hea r wha t you thin k abou t that , an

d specificall yon th e poin t o f ho wthe grouping s migh t b e use d t o mee t tha t need .

MR . DASTUR : I' d lik e t o addres s tha t issu e fo r a moment , please . Th e ke ypoin t tha t w e wan t t o mak e her e i s tha t i f EP Aconclude s tha t ther e i s a Sectio n 4 finding tha t —

MR . PASSAVANT : Well , there' s a Sectio n 21 1 finding . MR . DASTUR : Okay , bu t I' msaying tha t i f there' s a Sectio n 4 finding unde r TSC Atha t you'r e require d t o d o testing , an d tha t i f thi s testing progra m goe s beyon

d th e acut e testing phas e int o chroni c testing , an

d chroni c testing , you know , you'r e talking abou t si x an

d seve n figur e test s in term s o f dolla r value , pe

r compound , pe r test , an d that' s goin

g t o be severa l test s o n eac h compound , wha t w e don' t wan t t o hav e t o happe n i s fo r a smal l segmen t o f th e industr yt o hav e t o bea r tha t burden , an d essentiall yb

yexclusio n
w e don' t wan t to , fo r example , in an ywa yjeopardiz e th e reimbursemen t provision s unde r Sectio n 4 o f TSCA . Tha t



### 2 6P.2 8

J woul d preven t u s fro m havin g a mor e equitabl e sharing o f thi s burde nb

y the industr

y itself . So , that' s reall y

the issu e tha t w e trie d t o make , i s tha t i f EP A make s a judgmen t her e tha t
an y compan

y tha t ha s sale s volume s o f les s tha n$4 0 millio ni s exempted , w e migh t hav e a toug htim e going afte r the

m unde r Sectio n4 fo r reimbursement , i f EPA' s conclusio neventuall y play s ou t tha t larg e scal e test s
ar e require d o

nthes e chemicals . MR . PASSAVANT : Well , yo u understand tha t you'r e referrin g t o TSCA , an d we'r e referrin g t o the Clea nAi r Act , an d unde r th e Clea nAi r Ac t we have
no suc hexclusions. We hav e very grea t latitud e i nwha t provision s we ultimatel y pu t forth . Th e reasonwe pu t fort hth e $4 0 millio nwa s tha t tha t was , you know , on e stic k inthe mu

d tha t we coul d loo k a t an

d say , well , here' s wha t on e othe r progra m ha s done , an

d we wan t t o ge t you r respons e t o that , an d I canse e we go t it . MR . DASTUR : M

y concer ni s tha t i f testin g i s require d unde r Sectio n4 , i f EP A find s tha t th e authorit y

unde r Sectio n4 o f TSC A provide s i t wit h

mor e latitude , let' s say , tha nunde r Sectio n21 1 o f the Clea nAi r Act , the nwe don' t wan t som e positio ntake n unde r th e Clea nAi r Ac t t o hav e lega l impac t onSectio n


### 2 7P.2 9



### 4 . MS . GRAHAM : I have a questio nabou t you r statement s her e o nth e combustio no f thos e additive s tha t consis t onl y o f carbon , hydrogen , nitrogen , an

d oxygen . I' m

no t a chemist , s o I' m curious . Yo u sa

y her e tha t th e combustio nproduct s ar e negligible , being fo r th e mos t par t wate r vapo r an d carbo ndioxide . Thes e products , ho w wel l have the

y been studied ? I s ther e complet e combustion ? I s ther e 9 0 percen t combustion ? Wha t ar e the detail s there ?

MR . ZIMMERMAN : That' s somethin g we'r e workin g o

nrigh t no

w i nou r laboratorie s whe nwe cam e u p wit htrying t o pu t thi s progra m togethe r an

d on e o f the
reason s we aske d fo r a nextensio nonth e deadlin e fo r writte ncomments , s o we cange t al l thi s data . Runnin g thermographi c analyses , I cansa y th e initia l wor k I hav e seen , mos t recentl y jus t yesterday

befor e I left , show s tha t mos t o f thes e additive s ar e totall y broke n apar t b

y 50 0 C , an

d th e temperature s insid e th e combustio nengine s ar e considerabl y greate r tha n50 0 C . So , again , we wan t t o develo p mor e informatio nonthat , provid e mor e documentation , bu t i t appear s tha t thes e wil l be completel y combuste d wit hth e fuel . MS . GRAHAM : Thank you . 

### 2 8P.3 0



### "~ l MS . GILHOOLEY : Hav e ther e eve r bee nan y studie s tha t eve r showe d tha t som e compound s mad e o f thes e fou r element s pose d healt hhazards ?

MR . ZIMMERMAN : Oh , yes , certainly . MS . GILHOOLEY : Well , coul d yougiv e an y examples ? MR . PASSAVANT : Hydroge ncyanide .

MS . GILHOOLEY : Hydroge ncyanide , certainly ; s o i s benzene , I gues s that' s a carcinogen . So , there' s some . Thi s woul d exemp t som e substance s whic hare , I tak e it , know ncarcinogens ? MR . ZIMMERMAN : I' m talkin g abou t exemptio nfro

m emission s testing , combustio no f these . Also , we kno

w these , an

d we g o int o thes e unde r TSC A 4

an d everythin g else . I' m saying , the ris k o nthes e a t th e trea t leve l t o th e consumer , whe nhe see s somethin g tha t i s adde d bac k a t th e beginnin g o f th e pipelin e a s a pipelin e corrosio ninhibito r tha t finall y get s i

nth e fue l a t th e en

d a t a coupl e part s pe r million , we need t o conside r an

d weighthi s ris k an d the exposur e leve l

a t tha t point . MR . PASSAVANT : Mr . Zimmerman , ar e yo u sayin g exemptio nfro m the emissio ncontro l syste m impact s a portio no f thi s rule , o r all , becaus e o f the


### 2 9P.3 1

exposur e basis ? MR . ZIMMERMAN : I thin k tota l exemption , carbon , hydrogen , nitrogen , an d oxygen , fro

m the emission s cycle . MR . PASSAVANT : I mean , specificall y the emissio ncontro l syste m impact s the issues ? MR . ZIMMERMAN : Right , an d I think a
mor e considere d approac hma y be a firs t tie r cu t fro m th e othe r issues .

MS . GILHOOLEY : Woul d ther e be an y wa y tha t you woul d kno w tha t th e ris k woul d be belo w a certai nlevel , yo u know , belo

w on e ina million , o r belo w som e possibl y

acceptabl e ris k leve l i f yo u exempte d testin g base d onthei r concentrations ?

MR . DASTUR : Yes , I think i f th e EP A
wer e t o us e thi s informatio ni nthei r ris k assessmen t models , an

d I don' t kno

w wha t th e trigger s ar e tha t yo u woul d us e inthi s case , wer e i t t o b e on e i

nte nmillio n
o r on e i

na millio no r whateve r i t is , bu t you could , o n th e basi s o f exposure , exemp t thes e fro m the base , fro

m th e standpoin t o f sayin g tha t ther e woul d be littl e o r
no ris k o f cancer , fo r example , becaus e peopl e wh o woul d be handlin g the chemica l i nth e industria l atmosphere , basicall y

they wea r protectiv e clothing , mask s an ds o


### 3 0P.3 2

l 1 L . J forth . B y th e time th e ultimat e consume r i s expose dt o the chemical , he' s reall y no t expose d t o i t becaus e the molecul e unzip s i nth e automobil e engine , an d you'r e no t expose d t o thes e ver y comple xorgani c compounds , bu t jus t t o thei r componen t elements , lik e carbon , hydrogen , oxygen , an

d s o on , carbo ndioxid e an d wate r vapor . MS . GRAHAM : You'v e mentione d tha t
severa l times , an

d I jus t fee l obligate d t o commen t tha t everythin g you sa y canbe true , bu t a s you say , yo u haven' t studie d it , s o yo u don' t kno

w tha t it' s true . There' s stil l th e matte r o f th e potenc y o f th e compound , tha t non e o f u s woul d wan t t o be expose d t o eve na grai n
o f plutonium . Th e exposur e woul d be really , reall y small , bu t i f it' s plutonium , God forbid .

Likewise , it' s okay t o ge t expose dt o a
very highleve l o f a

ninnocuou s compound . So , whe nw e think abou t risk , a s you said , ther e i s th e exposure , ther e i s th e health , bu t w e can' t focu s exclusivel y o n
on e o r th e other . They ge t tied together . So , you r poin t i s wel l taken , bu t I fee l tha t the healt hsid e i s being underemphasize d i nyou r statements. MR . DASTUR : Well , I gues s youcoul d sa y that , excep t tha t I think you hav e t o tak e int o accoun t the cos t o f developing . Fo r example , i f you wer e t o ru n


### 3 1P.3 3

a cos t —

the onl y

wa y t o definitivel y

answe r th e questio na s t o whethe r the chemica l ha s carcinogeni c potentia l i s t o ru na carcinoge nbioassay . Youwoul d have t o run , fo r thes e chemicals , probabl y b y the derma l rout e o r the inhalatio nroute . B y th e inhalatio nroute , i f yo u wer e t o ru

na tw o yea r bioassay

o nrats , you'r e talkin g abou t testin g cost s o f abou t a millio nan da hal f pe r chemica l fo r the larg e numbe r o f compound s tha t
ar e available . Ar e we reall y saying tha t it' s reall y justifie d fro

m a resourc e standpoin t t o pu t thos e kin d

o f resource s int o answerin g thes e questions ? I think that' s basicall y

on e o f th e question s tha t we'r e asking . On e wa y t o approac hi t woul d b e t o loo k

a t i t fro

m th e exposur e standpoint . Now , I agre e tha t you hav e t o look bot ha t exposur e an d a t healt hhazard , bu t I think you canweigh t it . I think you cansa y tha t i f th e exposur e i s s o minimal , i s i t reall y necessar y

t o spen d $ 2 millio nt o tes t the carcinogenicity ?

MS . GILHOOLEY : I s ther e anythin g t o giv e you an

y handl e o

nwhethe r i t coul d be extremel y potent , beside s running a bioassay ?

MR . DASTUR : Well , i t al l depend s o nthe endpoin t tha t you'r e tryin g t o answer . Yo u cange t a
very good assessmen t o f genera l compound toxicit y fro m a


### 3 2P.3 4



### "~ l 

## J chroni c standpoin t running a 9 0 da y sub-chroni c study , let' s say . Tha t woul d give yo u a nindicatio nfo r almos t al l endpoint s excep t cancer , unles s yo u have somethin g i nthe protoco l fo r developmenta l or reproductiv e effect s o r teratogenicity , whic har e separat e endpoints .

Bu t yo u coul d ge t som

e kin d o f a n indicatio ni f yo

u wer e t o run , let' s say , a nacut e tes t battery . Fro

m a nacut e hazar d standpoint , i f yo uwer e t o ru nsomethin g u

p to , let' s say , a 1 4 da y study , yo

u woul d have som

e indication s a s t o whethe r the compound ha s som

e measur e o f toxicity . Fo r example , someon e mentione d hydroge ncyanide . Ther e i s no t muc h informatio nonthe chroni c toxicit y o f hydroge ncyanide . Th e reasoni s ver y simple , becaus e it' s suc ha stron g acut e poiso nthat , yo u know , the anima l i s going t o kee l

ove r lon

g befor e you'v e teste d fo r chroni c effects .

So , thos e ar e som e o f the thing s we ca n do , bu t we need time . We need tim e t o asses s al l o f that ; we nee d tim e t o pu t thi s al l together , an dthat' s reall y wha t we ai m

for . MS . GILHOOLEY : I had on e othe r are a o f question s abou t you r reques t abou t the smal l busines s exemption , which , I tak e it , i s tha t everybod y shoul db

e treate d alik e an

d tha t i f ther e i s one , al l companie s


### 3 3P.3 5

1— 1 L J 

### shoul d be eligibl e fo r i t i f the ymak e a smal l volume , irrespectiv e o f th e siz e o f thei r revenues , o r conversely , i t shouldn' t b e availabl e t o anybody .

On allowing th e larg e compan yt o be eligibl e i f thei r volume i s smal l in a certai n category , d o you knowi f there' s an yprecedence , i f an ystatut e ha s eve r bee n interprete d tha t way , becaus e ther e hav e bee n smal l busines s exemption s in othe r statutes , I' m
sure , bu t i t woul d be interesting t o knowi f an yo f the

m hav e bee n interprete d tha t wa yo r i f an

yo f thes e smal l busines s provisions , SBA , th e Smal l Busines s Administratio n ha s eve r don e that ?

MR . ZIMMERMAN : Tha t i s no t wha t I wa s trying t o impl yin wha t I wa s writing . I wa s jus t trying t o brin

g ou t th e poin t tha t we'r e though t o f a s D u Pont , a ver

ylarg e company . M ybusiness , th e petroleu

madditive s business , wer e i t no t withi n D u Pont , an

d we'r e onl ydealing wit h fue l additives , th e bi g D u Pon t Compan

ywoul d be a smal l business , i s al l I
wa s trying t o say .

I wa s no t saying tha t yo u shoul d interpre t i t tha t wa yan d jus t look a t tha t segmen t an d fi t i t in . I thin

k i f yo u di d that , you' d fin d almos t everybod

yher e i s smal l business . I thin k that' s reall y

3 4P.3 6



## "~ l J th e poin t I' m tryin g t o make , i s thi s industry doe s no t hav e giant s i

nfuel s additives . It' s mostl y a nindustry
o f a larg e numbe r o f smal l businesses. So , t o penaliz e thos e wh o happe nt o b e associate d wit ha large r company , I think , i s unfair .

MS . GILHOOLEY : So , woul d you think tha t you r uni t shoul d b e eligibl e fo r th e smal l business ?

I' m saying . MR . ZIMMERMAN : No , no , that' s no t wha t

MR . DASTUR : That' s on e wa y t o look a t it , excep t tha t there' s nothin g i nth e statute s tha t woul d allo

w u s t o us e tha t becaus e th e wa y th e statut e i s defined , it' s th e paren t company' s asset s an dsale s volume tha t applies . It' s no t the busines s uni t itself .

Bu t eve ni f thi s testin g ha d t o be done , the poin t we'r e makin g is , let' s sa y i f you hadcompound X , an d ther e wer e 2 0 companie s involve d i nit , an

deve n i f D u Pon t wa s no t the larges t manufacturer , let' s sa y tha t i t wa s decide d t o ru nthe cance r bioassay whic h cost s a millio nan d a half , the nwe sa y tha t tha t money , tha t tha t cos t shoul d b e shared , ona volume basis , fo r example , an

d ther e i s preceden t fo r tha t unde r Sectio n4

o f TSCA . Yo u know , i f companie s come together , they shar e costs , an

d the y shar e cost s primaril y o nth e basi s



### 3 5P.3 7

o f thei r productio nvolumes . So , we'r e saying tha t tha t shoul d b

e th e wa

y tha t thi s testin g i s als o handled , i f i t come s t o that .

MR . GRAY : Ho

w d o yo u handl e a ne

w organizatio ntha t start s manufacturin g tha t materia l afte r the basi c testin g ha s bee nconducted ? I s ther e
som e mean s o f then , i f th e testing' s beenpai d fo r b y the existin g marketers , doe s th e ne w entry compan

y jus t basicall y

have a fre e rid e i nterm s o f tha t cos t o f doing business ? MR . DASTUR : Well , I believ e unde r Sectio n4 o f TSC

A ther e i s a requiremen t tha t allow s the reinvestmen t claus e t o appl y fo r a perio d o f five year s fro m the tim

e tha t the las t tes t resul t i s submitte dt o EPA . I' m

no t sur e o f th e exac t timing , bu t I think that' s right , whic hmean s tha t someon e woul d hav e t o wai t fo r tha t perio d o f time . I f he decide s t o com e i n afte r tha t period , yes , I gues s he woul d ge t a fre e ride , unles s there' s som e wa y t o ge t hi m

in . MR . GRAY : An

y mor e questions ? MS . SIEGELBAUM : Yes , i nconnectio nwit h you r propose d exclusio nfo r th e additive s comprise d o f the carbon , hydrogen , nitrogen , an d oxygen , you mentione d tha t th e worker s wh o wer e puttin g th e fue l


### 3 6P.3 8



### J additive s int o th e fue l ar e wearin g certai nprotectiv e equipmen t tha t woul d mitigat e risk . I' m curiou s a s t o you r view s onincluding certai nbasi c criteri a fo r the mandator y

us e o f protectiv e equipmen t a s necessary , a s par t o f the exclusion , becaus e i f w e wer e t o develo pa n exclusio nfo r baselin e additive s like thi s i nsmal l quantities , w

e woul d probabl y

wan t t o creat e som e reasonabl e criteri a tha t coul d be used acros s the board withou t havin g t o g o throughestablishin g permissibl e exposur e limits . MR . ZIMMERMAN : I' m no t quit e sur e I hear d th e question . I' m havin g a grea t dea l o f difficult y

hearin g you . MS . SIEGELBAUM : I' m sorry ; essentiall y th e questio nwas , I wa s seekin g you r view s o nthe us e o f worke r protectio nfo r the propose d exclusio nfo r the fue l additive s foun d o npag e fou r o f you r presentation . Yo u mentione d befor e tha t thes e worker s ar e generall y a t lo w ris k o f exposur e becaus e o f thei r us e o f certain , whethe r it , be glove s o r fac e masks , an d I wa s curiou s a s t o wha t assurance s the Agenc y woul d hav e tha t thes e type s o f measure s woul d be take nona consisten t basis ? I mean , ar e we suppose d t o assume tha t they ar e used ? MR . ZIMMERMAN : I think tha t alread y


### 3 7P.3 9

l

_J fall s unde r othe r guideline s a s i nOSH A an d s o on , our safet y dat a materia l sheets . Ou r customer s ar e al l reminde d o f these , worke d wit hthese , an d ou r customers , being larg e oi l companies , ar e no t going t o tak e a chanc e an

d no t wor k safely .

MR . PASSAVANT : I wa s jus t involve d wit h that , althoughI don' t kno w tha t that' s particularl y relevan t t o thi s rule . I think tha t th e poin t i s tha t ther e i s no t a permissibl e exposur e fo r every chemical . So , I think Heidi' s questio ni s mor e along th e line s of , i f w e wer e t o tak e that , tak e you r premis e tha t thi s i s acceptable , the nwha t enforcemen t provision s ar e ther e fo r u s alon g thos e lines ?

I' m no t sur e that' s directl y relevan t t o wha t we'r e trying t o d o here , bu t i t i s a nimportan t point . I think you ar e makin g th e statemen t tha t there' s no t a ris k i nth e refinery

are a o f th e plant s becaus e thes e peopl e tak e o nth e adde d persona l protectiv e equipmen t o r ventilatio nsystem s o r whateve r
now , an

d you ma

y no t be necessaril y abl e t o coun t o

n that . MR . DASTUR : Well , on e approac htha t the EP A coul d tak e is , I believ e unde r Sectio n9 o f TSCA , fo r example , you coul d g o t o OSHA , an d OSH A coul d



### 3 8P.4 0

1 1 v . J establis hpermissibl e exposur e limit s base do na certai n criteria , an dsa y

tha t onc e yo uhav e a nOSH A PEL , the n there' s a nincumben t (inaudible ) that' s mandate do nth e industr y

t o b e abl e t o mee t tha t requiremen t an dleav e i t u pt o th e industr y t o decid e ho w

bes t the y

wan t t o
mee t it , whethe r the y wan t t o mee t i t throug h engineerin g controls , suc htha t the y operat e belo w

th e PEL , o r i ncase s wher e the y canno t operat e unde r thos e limits , tha t the y

pu t peopl e i nmask s an dthing s o f tha t nature , MR . GRAY : Than kyo uver y much ; we'r e lookin g forwar dt o you r continue dassistanc e i n developin g th e proposal .

MR . ZIMMERMAN : Than kyou . MR . DASTUR : Than kyou . MR . GRAY : Nex t w e hav e th e America n Petroleu m

Institute , i f you'l l com e forward , please .

MR . CAVALLI : Goo dmorning ; m y nam e i s Richar dCavalli . I' m a toxicologis t b y trainin g an d manage r o f produc t safet y an dhealt hris kassessment s fo r Chevro nCorporation . I als o serv e a s th e chairma n
o f th e America nPetroleu m Institute' s Healt hStrateg y
an dRespons e Tas kForce . Wit hm e toda y ar e Jerr y

Levin e
o f Amoc o Oi l Company , Davi dDea l o f th e AP I staff , an d


### 3 9P.4 1

L J Gerry Raab e o f Mobile , wh o wil l hel p wit hth e question s
an d answers , o r the answer s t o the questions . Today , o n behal f o f API , I' d like t o shar e wit hyo u ou r pre liminary

thinkin g o

nthe emergin g Clea nAi r Ac t 211(b ) testin g rul e describe d i nthe Agency' s Augus t 7 , 199 0 Advanc e Notic e o f Propose d Rulemaking .

Th e America nPetroleu m Institut e i s a nationa l trad e associatio nwit hove r 20 0 membe r com panie s whic hrepresen t al l sector s o f the petroleu m industry : exploration , production , transportation , refining an

d marketing . Give nthe focu s o f thi s rule making , i t i s significan t tha t AP I member s accoun t fo r th e vas t bul k o f fue l an d a substantia l amoun t o f the fue l additive s manufacture d an d markete d i

nth e nation . AP I member s are , therefore , directl y an d significantl y affecte d b

y th e outcome o f thi s rulemaking . We wil l be submittin g extensiv e writte n comment s i

nth e cours e o f thi s importan t rulemaking , bu t today , a t wha t w

e fee l i s a

nearl y

formativ e stage , w e wil l addres s thre e basi c issue areas , namely , th e need t o focu s th e testin g rule , the need t o adop t appropriat e testin g methodology , an d th e nee d t o addres s certai n critical , practica l considerations .

Wit hregard t o focusin g the tes t rule ,


### 4 0P.4 2

~1 

## J i nth e ANPR , EP

A recognize d tha t th e shee r numbe r o f candidat e substance s fo r testin g unde r a 21 1 rul e i s staggering . Ove r 6,00 0 fuel s an d fue l additive s ar e alread y registered . Moreover , whe nthe pending Clea n Ai r Ac t Amendment s ar e passed , the 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 ) testin g rul e wer e t o addres s no t onl y registere d fuel s an

d fue l additives , bu t the man y possibl e combina tion s thereof , the numbe r o f testin g possibilitie s woul d expand further . Accordingly , the AP I propose s tha t EP A employ a fe w interlinked , simplifyin g principle s t o reduc e the scal e o f the undertakin g t o a manageabl e size . I f employed , thes e principle s coul d reduc e th e scientifi c uncertainty , whil e recognizin g th e practica l limit s o f ou r resources , bu t withou t compromisin g the statutor y

purpos e o f 211(b) .

Firstly , the 211(b ) testin g progra m shoul d be limite d t o ai r emission s attributabl e t o evaporatio nan

d combustio no f moto r vehicl e fuels . Thi s woul d includ e no t onl y diese l fue l an

d gasolin e but , a s th e ANP Rsuggests , fuel s suc ha s methanol , ethanol , liquefie d petroleu m gas , an

d compresse d natura l gas , a s


### 4 1P.4 3

wel l a s an

y othe r moto r fuel . Th e term s o f the Clea n Ai r Ac t an

d it s statutory

history

mak e i t clea r tha t Sectio n211(b ) testing wa s adde d t o the statut e t o provid e a factua l bas e fo r th e Administrator' s exercis e
o f regulatory

authorit y

unde r 211(c) . Whil e 211(c ) i s broad i nsom e respects , giving the Administrato r authorit y t o contro l o r prohibi t the us e o f fuel s o r fue l additives , tha t authority , b

y the 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 product s endange r th e publi c healt ho r welfar e directl y
o r impai r t o a significan t degre e th e performanc e o f an y emission s contro l syste m i ngenera l use . T o b e sure , ra

w liqui d fuel s an

d fue l additive s hav e exposur e propertie s no t linked t o evaporatio no r combustion , suc ha s eye , skin , o r ora l exposure . However , an y testin g t o discer nthes e effect s is , we believe , outsid e th e scop e o f th e Clea nAi r Act . Thes e othe r kind s o f exposure s ar e alread y addresse db

y othe r statutes . T o the exten t tha t thes e othe r kind s o f exposur e rais e concern s withi nth e responsibilit y o f EPA , an

y testin g deeme d necessary shoul d be undertake n unde r th e Toxi c Substance s Contro l Act .

Parenthetically , I woul d lik e t o not e


### 4 2P.4 4



### "~ 1 

### J tha t a t thi s tim e ther e i s a meetin g being hel di n Swede nt o addres s the questio no f wha t dat a ar e availabl e o

npetroleu

m product s an

d wha t dat a ma

y b e needed . I believ e tha t EPA , a s wel l a s API , an d representative s fro m man y othe r government s ar e i n attendanc e a t tha t meeting .

Ou r secon

d poin t i s tha t EP A shoul dtak e ful l advantag e o f the relevan t informatio nalread y develope d o r being develope d outsid e an y 211(b ) testin g process . Fo r example , ther e alread y exist s a databas e
o nthe healt heffect s o f fue l an d fue l additiv e emissions . Thi s databas e include s anima l studies , human exposur e studie s an d epidemiologica l studie s involving fuel s an

d exhaust .

Mor e specifically , ove r the pas t 1 3 years , the TSC

A progra

m ha s bee nevaluatin g dat a needs , including healt han d environmenta l effect s testin g fo r liqui d fuel s an

d fue l additives . Durin g th e earl y 1980's , th e Interagenc y Testin g Committe e prepare dan d reviewe d severa l Toxicologica l Profile s onke y petroleu

m substances , including unleade d gasoline . Specifically , th e IT C looked a t th e healt han d environmenta l effect s informatio navailabl e o nunleade d gasoline . A s par t o f tha t study , AP I an d othe r member s o f the petroleu m



### 4 3P.4 5

industry

provide d EP

A wit hdat a o

ngasolin e an

dassiste d the IT C i

ncharacterizin g exposures . Inaddition , the IT C ha s als o evaluate d variou s fue l additives . Fo r example , on e o f thes e investigation s le d t o th e decisio n t o conduc t a tes t progra m t o examin e the healt heffect s fro m exposur e t o MTBE .

Thirdly , whateve r th e univers e o f fuel s
an d fue l additive s is , thos e deeme d essentiall y the sam

e shoul d be groupe d t o avoi d duplicativ e testing . Inthe ANPR , EP

A recognize s thi s commonsens e principle , observin g furthe r tha t the experienc e alread y collecte d i nconnectio nwit hthe , substantiall y similar , provision s o f 211(f ) ma y assis t i

ngroupin g fo r 211(b ) purposes . AP I strongl y concurs . Wha t we urg e EP

A no t t o do , however , i s t o formulat e groupin g criteri a o nth e basi s o f th e chemica l compositio nand/o r structura l activit y propertie s o f th e ra w fuel s an

d fue l additive s alone . Consisten t wit hth e emissio nfocu s o f th e Clea nAi r Act , groupin g fo r testin g 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 nproces s an d exhaus t treatmen t proces s tha t affec t the typ e an d amoun t o f emission . Wit hrespec t t o exhaus t emission s specifically , th e fac t



### 4 4P.4 6

•" 1 i s tha t combustio nan d exhaus t treatmen t processe s ar e designe d t o operat e o na wid e rang e o f fuel s an dfue l additive s bu t for m a muc hnarrowe r rang e o f emissio n products . An

y 211(b ) testin g progra m shoul d tak e advantag e o f thi s simplifyin g aspec t o f the process .

Perhap s eve nmor e relevant , the Ai r Qualit y

Improvemen t Researc hProgra m being carrie dou t b y the oi l an

d aut o industrie s o na nexpedite d basi s shoul d provid e withi nth e nex t tw o year s bot ha detaile d emissio ncomponen t analysi s an d th e analytica l abilit y t o extend measuremen t t o ver y lo w levels . Thi s progra m wil l evaluat e th e evaporativ e an d exhaus t emission s o f 1 7 differen t gasolin e formulations , a s wel l a s methanol , ethanol , MTB E an

d ETB E blends , i

nbot hne

w vehicle s an

d

a representativ e flee t o f olde r vehicles . Thes e test s
ar e being oversee nb y a pane l o f independen t expert s fro m academia , an

d thes e dat a wil l be give ni nthei r entiret y

t o EP A an d othe r regulatory agencies . Dat a fro m th e firs t phas e coul d be availabl e b y the en

do f thi s yea r o r earl y nex 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 characterizin g th e natur e an d exposur e potentia l o f moto r fue l emissions . Thes e data , whe nviewe d i

ncombinatio nwit hth e emission s reducing


### 4 5P.4 7



### potentia l o f applicabl e regulation s an d existing emissio n reductio n technology , ar e critica l fo r shapin g
an d implementing th e emerging 211(b ) program . Wit h thes e dat a EP

Ashoul d establis h a baselin e agains t whic h th e significanc e o f exposur e can be assessed , grouping s determined , an

d testing priorit ydecision s made . Wit h regard t o adopting appropriat e tes t methodology , a t thi s earl ystag e i n th e rulemaking , wit h
s o man ythreshol d question s unresolved , i t i s no t possibl e fo r u s 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 ysuggested , focusing on emissions , using groupings , an d taking ful l advantag e o f dat a nowexisting o r bein g develope d outsid e th e program , al l hav e majo r implication s fo r th e selectio n
o f testing protocols .

Consisten t wit h th e suggestion s alread y made , 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 h effects , environmenta l effects , chemica l fat e test s tha t hav e alread ybee n developed , recognizing o f cours e tha t some
o f thes e guideline s ma ynee d t o be modifie d t o sui t th e purpose s o f th e 211(b ) testing program .

Moreover , w e believe , a s th e ANPR


### 4 6P.4 8

suggests , tha t a tiere d approach , properl y constructed , coul d identif y

thos e substance s tha t need furthe r evaluation . Thi s woul d eliminat e unnecessary testin g
an d focu s limite d resources , suc ha s ou r limitedtestin g facilit y

capabilities , o

nthe in-dept htestin g neede di n critica l areas . On e fundamental , underlyin g questio ni s th e technica l an

d scientifi c difficult y o f carryin g ou t thes e evaluation s a t the lo w level s o f exposur e actuall y encountered . Grea t scientifi c uncertaint y exist s fo r the easier , bu t fa r mor e questionabl e practic e o f extrapolatin g exposur e effect s fro m highe r tes t level s t o th e very

lo w level s o f actua l exposure . Howeve r th e Agenc y resolve s thi s dilemm a
an d whateve r screenin g procedure s i t employs , w e urg e th e Agenc y

t o focu s testin g onris k evaluation , rathe r tha nsimpl e hazar d identification . T o th e fulles t exten t possible , th e 211(b ) testin g progra m shoul d enhanc e th e Agency' s abilit y t o asses s an

d compar e risk s
a s th e anteceden t fo r soun d regulatory

action . Wit hregard t o addressin g certai n critical , practica l considerations , inth e ANPR , EP A recognize d tha t the shapin g o f a nappropriat e 211(b ) testin g progra

m no t onl y

involve s a selectio no f whic h


### 4 7P.4 9



### fuel s an

d fue l additive s t o tes t an d ho wt o tes t them , bu t als o involve s a constellatio n o f practica l con siderations : cost , cos t sharing , handling o f proprietary data , avoidanc e o f undu e disruptio n o f th e moto r fue l market , an

d th e need t o harmoniz e th e variou s 21 1 programs . I n th e detaile d writte n comment s w e wil l submi t late r in th e rulemaking , w e wil l addres s thes e
concerns , bu t fo r th e purpos e o f today' s hearing , we wil l limi t ou r remark s t o th e latte r two .

First , AP I believe s tha t EP Aha s th e authorit yt o implemen t a 211(b ) testing progra min a
manne r whic h avoid 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

y211(e ) can 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 tha t EP

A can issu e a temporaryregis

tration , a t leas t fo r thos e fuel s deeme d substantiall y simila r t o fuel s alread yregistere d an

d being marketed . In reviewing th e ANPR , i t i s clea r tha t EP A recognize s thes e possibilities . AP I encourage s EP A t o adop t them . Second , EP

A need s t o harmoniz e it s


### 4 8P.5 0



### "~ l J differen t 21 1 programs , paying specia l attentio nt o an y
ne w fue l certificatio nprogra m establishe d b

y th e Clea n Ai r Ac t Amendment s no w pendin g befor e Congress . T o som e exten t the ANP Rdoe s addres s thi s relationshi p betwee n the emergin g 211(b ) progra m an d the existin g 211(f) , substantiall y

similar , program , eac ho f whic hma y involve d testing . Whe nClea nAi r Ac t Amendment s ar e enacted , i t wil l becom e cleare r t o EP

A an d industry

jus t wha t need s t o be don e t o harmoniz e thes e tw o program s wit han

y ne w fue l certificatio nprogram . Bu t here , again , we believ e EP A ha s ampl e authorit y unde r the existin g Clea nAi r Ac t t o harmoniz e al l thre e programs .

Th e AP I recognize s tha t th e formulatio n
o f a 211(b ) testin g progra m pose s man

y issue s involving highlevel s o f scientifi c uncertaint y an d whos e resolutio ninvolve s majo r resourc e implication s fo r EP A
an d industry . We welcome the opportunit y t o participat e i nthi s proces s an d hop e tha t EP

A wil l tak e ful l advantag e o f th e expertis e we have t o offe r i nwha t promise s t o be a

nextensiv e an

d challengin g rulemaking ; thank you . MR . GRAY : Thank you ; i t sound s lik e i f th e ANP Rwa s th e essenc e o f ou r job , we'v e don e a prett y good job , bu t th e nex t ste p o f movin g thi s concep t int o



### 4 9P.5 1

l

_J som e mor e specifi c requirement s i s going t o be the crucia l phase . I' m no t detectin g an y basi c disagreemen t thoughi

nterm s o f the framewor k o f wha t wa s lai dou t i n th e ANPRM , o f the tiere d approach , o f the definitio no f certai nbas e materials , fuel s o r fue l additives , comparin g others , o r ne w fue l o r fue l additive s t o thos e base , i

nterm s o f th e determinatio no f whethe r mor e testin g shoul d be required , e t cetera . Thos e basi c principle s see

m consisten t wit hyou r suggestion . A m I missin g somethin g there , firs t o f all ?

MR . CAVALLI : Th e on e facto r tha t yo u didn' t mentio ni s tha t i nth e ANP Ri t i s no t clea r tha t al l o f thos e principle s woul d be applie d wit hth e emissio nspectru

m o f a fue l o r fue l additiv e i nmind . We ar e no t encouragin g yo u t o adop t a broad-base d testin g syste

m fo r ra

w fuel s an

d ra w additives , bu t rathe r t o concentrat e o nth e emission s a s drivin g the
need fo r an

y testin g an

d t o focu s an

y testin g onne

w an d differen t o r o

nunstudie d o r uncharacterizabl e emissions . MR . GRAY : Well , a s yo u canrecognize ,
we ar e tryin g t o coordinat e wel l withi nth e Agenc y t o addres s othe r possibl e environmenta l effect s o f fue l o r fue l additives , whethe r i t be inground water , o r a s yo u


### 5 0P.5 2

1 1 u J said , direc t exposur e o f th e material , an d definitel y we'l l b

e workin g wit hyou r commen t i nmind . Bu t focusin g then , fo r example , o nthe exhaus t an

d evaporativ e emission s side , a s yo u talke d about , yo

u stil l qualifie d it , the tiere d approach , like i nthe ANPRM , i f properl y constructed , wha t othe r features , fundamenta l feature s shoul d we be considering ?

Wha t w e hop e t o d o i s fram e a noveral l approac hthroughthi s proces s prett y quickly , s o tha t we
canthenge t int o the busines s o f defining , ar e ther e bas e fuels , being fuel s wher e ther e i s sufficien t informatio navailabl e t o b e classifie d a s base ? I f not , wha t additiona l informatio nwoul d be appropriat e t o have collecte d fo r th e variou s fuel s tha t we migh t b e considering ? Thos e ar e th e stage s wher e w e needt o b

e movin g to , bu t firs t w e woul d like t o hea r i f ther e ar e othe r component s o f the proces s tha t shoul d be adde do r component s o f wha t w e suggeste d i

nth e Advanc e Notic e tha t aren' t appropriate . An y othe r specific s ther e tha t you cangive us ? MR . CAVALLI : I canonl y giv e yo

ua piec e o f genera l guidanc e there . Th e mos t critica l step , t o me , i

nyou r tie r i s ste p one , an d possibl y

ste p two , wher e you collec t th e informatio ntha t i s know n


### 5 1P.5 3

L J abou t a fue l o r additiv e i nthi s cas e an

d it s emission s spectru m an d look a t the informatio nknow no nth e potentia l healt heffects , environmenta l effects , an d effect s o

nemissio ncontro l systems . Ther e i s a vas t
array o f informatio navailabl e o nthos e subject s fo r fuel s tha t have bee nmanufacture d an d distribute dove r the pas t 3 0 t o 5 0 years , an d I woul d urg e th e Agenc y personally , a s a scientist , t o pa y a grea t dea l o f attentio nt o tha t bod y o f informatio nan d wha t i t say s abou t th e emission s o f thos e kind s o f fuels .

Tha t wil l be a muc hmor e difficul t exercis e tha nmakin g a lis t o f toxicology studies , a s
on e find s unde r Sectio n4 o f TSCA , an d puttin g littl e check s afte r it . A lo t o f tha t informatio ni s no t i n tha t form , bu t tha t informatio ni s very valuable . The
vas t bul k o f i t i s scientificall y valid , eve nthoughi t doesn' t confor

m t o specific , curren t TSC A testin g protoco l MR . PASSAVANT : Mr . Cavalli , on e o f the things , a s I hea r yo u say , i s tha t we'r e dealing , a s yo u recognize , wit hpotentiall y 6,00 0 products . Whil e som e
ar e similar , man

y ar e dissimilar , an d i t put s u s i

na positio nfo r m

e t o as k yo

u thi s question . Whil e i t i s certainl y

ou r inten t t o tak e a loo k a t everythin g that' s



### 5 2P.5 4



## " I J bee ndon e ove r th e las t 2 0 o r 3 0 year s i nthi s area , wher e woul d yo

u sugges t we go fo r thos e situation s wher e nothin g ha s beendone ? Tha t i s wha t brough t u s t o the ide a o f looking a t structura l activit y relationship s an d thing s suc ha s that , a s oppose d t o jus t assuming tha t w e woul d wal k int o i t wit hth e assumptio ntha t we'r e going t o have t o d o a full-blow nprogram ? MR . CAVALLI : I think th e simplifyin g procedur e tha t we'v e lai d befor e yo u is , unde r the Clea n Ai r Act , i f yo

u narro

w you r concer nt o emission s an d difference s i

nemission s tha t differen t kind s o f fuel s
o r fue l additive s produce , yo u cangreatl y

simplify , I believe , you r problem , sinc e emissions , a t leas t a s I understand them , d o appea r t o be fa r mor e simila r fo r differen t kind s o f fuel s thanthey ar e differen t fo r differen t kind s o f fuels .

I f yo u ar e concerne d unde r thi s Ac t wit h emissions , evaporativ e an d tailpipe , yo

u d o no t hav e t o
concer nyoursel f wit hthe acute , ora l toxicit y o f a fue l

o r a nadditive , becaus e tha t i s no t par t o f th e emission s equation . Wha t you d o hav e t o be concerne d abou t i s wha t evaporates . I think that' s wha t th e gentleme nfro

m D u Pon t wer e tryin g t o ge t across . I f you have a non-volatil e additiv e ina volatil e fuel ,


### 5 3P.5 5

L J tha t whic hi s going t o evaporat e fro m th e automobil e i s going t o b

e the volatil e part , no t th e non-volatil e part . So , b

y focusin g o

ntha t kin

d o f thing , yo

ud o begi nt o eliminat e block s o f materia l fro m tha t whic h you have t o conside r unde r the Clea nAi r Act .

MS . KRUEGER : O

npag e fou r o f you r testimon

y yo u mentio na

nexistin g healt heffect s dat a base . Whic hon e ar e yo u referring to ? MR . RAABE : There' s probabl y mor e publishe d literatur e o nfuel s an

d fue l healt heffect s tha nan

y othe r clas s o f compound s i nth e world . I

R devote d a

nentir e monographt o fuels , I RMonograp h45 , tha t wa s complete d an d publishe d in1989 . There' s als o I RMonograph46 , whic hwa s devote d exclusivel y t o automotiv e emissions . Ther e i s a nenormou s databas e being developed , a s wa s allude d to , a s aut o progra m tha t wil l speciat e a vas t numbe r o f emission s unde r differen t fuels . So , take ntogether , ther e i s a nenormou s data bas e alread

y i nexistence . Further , AP I ha s a larg e epidemiolog y progra m ongoing , looking a t th e distributio nhealt h effect s associate d wit hgasolin e distribution . So , collectivel y

there' s a

nenormou s se t o f dat a ou t ther e t o buil d on , an

d i t shoul d b

e looked a t first , including



### 5 4P.5 6

produc t testin g o f moto r fuels ,

MS . GILHOOLEY : Woul d yo u submi t tha t fo r the record , o r cite s t o it ?

MR . RAABE : Excus e me ? MS . GILHOOLEY : Wit hrespec t t o tha t testin g that' s ou t there , wil l yo u b e submittin g cite s t o it , t o the record ?

MR . RAABE : I woul d think I RMonograph 4 5 an d 4 6 i s readil y

availabl e t o th e Agency . Al l tha t ha s bee npublishe d an d i s alread

y i nth e record . Al l o f i t ha s bee nsubmitte d t o EPA , numerou s time s probably .

MR . PASSAVANT : On e o f thing s I' dlike t o follo

w u p oni s th e concep t tha t seem s t o b e pu t fort hb

y bot hD

u Pon t an

d yo u folks , tha t th e Agency , a t thi s point , i s going t o b e i na positio nt o mak e judgment s o r rul e i nthe nea r term , b y th e tim

e thi s rulemakin g i s done , be ina positio nt o mak e judgment s abou t certai nthings , an d i t seem s t o m

e t o be somewha t inconsisten t wit hth e basi c requiremen t tha t we'r e looking a t inthe Clea nAi r Ac t whic hsay s tha t ther e ha s t o be testin g done .

Wha t I hea r you sayin g onth e on e han d is , ther e ha s bee ntestin g done , bu t onth e othe r hand , I hea r yo

u saying , Agency , you g o ahea d an d mak e tha t



### 5 5P.5 7

judgmen t fo r us ; you g o throughth e registratio nwheel s fo r us , an

d excus e u s fro

m thos e requirements . I s tha t wha t I' m

hearin g yo

u say ? MR . CAVALLI : Well , I can' t testif y a s t o wha t yo

u heard , bu t I cantestif y tha t I don' t think I sai d that . MR . PASSAVANT : Okay .

MR . CAVALLI : Wit hregar d t o tha t point , I think tha t we woul d lik e t o se e you d o wha t I d o whe n I' m face d wit ha questio nlik e that , tha t come s t o m e on
a dail y

basi s withi nm

y company , an

d tha t i s t o se t u pa rul e whic hessentiall y say s tha t we wil l focu s fo r our testin g o

nth e kind s o f exposur e tha t result s fro m the
us e o f the fue l i na moto r vehicl e an d the emission s tha t com

e ou t int o th e ai r fro m tha t process . An dw e wil l use , yo

u use , o r we use , th e databas e tha t exist s t o mak e a findin g tha t th e fue l ha s bee nwell-studie d

an d well-characterized , a sor t o f TSC A typ e o f findin g wher e w

e hav e a sufficien t amoun t o f informatio nt o mak e
a regulatory

decision . Wher e there' s a gap i ntha t database , an

d wher e ther e i s testin g tha t woul dbe usefu l t o fil l tha t dat a base , the ntha t woul dbe a testin g recommendatio ni nm y case , requirement , perhap s i nyours . 

### 5 6P.5 8

1 

### 1

i L-. J MR . PASSAVANT : Inou r ANPRw e suggeste d that-th e Tie r 1 processin g woul d involve the differen t companie s seekin g registratio nt o bring tha t dat a befor e the Agency . I hea r yo u suggestin g tha t th e opposit e shoul d be done . I s tha t tru e o r not , i s tha t wha t you'r e saying ? MR . RAABE : I think wha t Dic k an dI ar e tryin g t o sa

y i s probabl y

tha t if , you g o throughthe process , whic hi s cour t mandate d i nyou r circumstanc e
now , you wil l conclud e tha t ther e i s probabl y very littl e need fo r additiona l testing . Tha t woul dbe a n expectation . We'r e no t sayin g tha t i s 10 0 percent , bu t we'r e saying tha t ther e i s a vas t bod y o f dat a ou t there , an

d it' s probabl y

no t necessar y

fo r EP

A t o apologiz e fo r no t having used tha t tes t rul e provisio n availability , becaus e they kne w ther e wa s a lo t o f materia l ou t ther e an d hav e bee nworkin g wit hi t fo r year s i

nothe r part s o f the program .

So , th e fac t tha t you'r e no w unde r a
cour t ordere d mandat e t o g o throughth e proces s essentially , we'r e saying tha t there' s a larg e databas e availabl e fo r th e process , an d a s you wor k throughtha t process , yo

u wil l probabl y

conclud e tha t ther e ar e bas e fuel s tha t hav e essentiall y adequat e dat a ou t there . 

### 5 7P.5 9

L . J 

### Whethe r th e Clea n Ai r Ac t Amendment s woul d necessitat e a modificatio n o f wha t bas e fuel s ar e i s a differen t issue , an d there' s certainl yne wfuel s
an d alternativ e fuel s o n th e horizon , fo r whic h ther e
ar e no t extensiv e testing program s in plac e o r alread y completed . So , i t depend s o n whic h phas e o f th e scheme tha t we'r e talking about , t o wha t exten t ther e wil l b e additiona l testing required .

MR . CAVALLI : Le t me tr yan d ge t bac k t o th e questio n tha t you asked . Ou r comment s wer e no t intende d t o reflec t on whomth e prope r part yt o gathe r information , reviewit , analyz e it , an d presen t i t is , an d I wa s making n o attemp t t o sa ytha t tha t wa s th e busines s o f th e Agency , a s oppose d t o th e busines s o f the regulate d industry . Furthe r dow n th e lin e w e ma

y reac h some conclusion s o n that , bu t w e di d no t inten d t o mak e tha t proposal .

MR . PASSAVANT : I gues s you coul d se e tha t ou r ANP Rdi d mak e that . W e too k a stab a t saying tha t w e fel t tha t wa s th e responsibilit yo f th e partie s tha t wer e seeking registration .

MR . CAVALLI : Again , I can onl ycommen t tha t that' s no t inconsisten t wit h mos t o f th e othe r activitie s o f thi s sor t tha t tak e place , bu t that' s no t



### 5 8P.6 0



### a n officia l position , J MS . GILHOOLEY : I gues s you kep t emphasizing tha t you shouldn' t tes t th e ra wfuel , you shoul d tes t th e emission s product . I wa s trying t o mak e
sur e I understoo d your point . D o you mean i t shoul d be inhalatio n testing , o r you shoul d tes t th e fue l afte r it' s bee n al l mixe d togethe r an d no t tes t separat e components ? I wasn' t full yfollowing wha t th e poin t wa s tha t you wer e trying t o focu s on .

MR . CAVALLI : I thin k ther e i s a differenc e betwee n th e nee d t o test , period , an d th e
nee d t o tes t unde r th e Clea n Ai r Act . Th e Clea n Ai r Act , w e believe , focuse s o n ai r tha t peopl e breath , an d further , we'r e talking abou t ambien t air , a s oppose d t o ai r in th e workplace . Wit h tha t construct , w e woul d urg e tha t an

ytesting require d o f fuel s an d additive s bea r a relationshi p t o tha t particula r situation .

TSC Aexamine s an

d ha s examine d actuall y th e genera l hazard s fro mfuel s a s item s o f commerce . Th e OSH Adeal s wit h th e hazard s o f fuel s in th e work

place . Th e Consume r Product s Safet yCommissio n deal s wit h th e hazard s o f fuel s a s consume r products . Rathe r than trying t o tak e th e whol e constellatio n o f healt h effect s o f fuel s an d pul l i t int o the Clea n Ai r Act , we

5 9P.6 1

1

_J woul d sugges t tha t yo u concentrat e you r effort s i nthi s rulemakin g o

ntha t t o whic hth e Ac t i s responsive , namel y ai r emissions . I t doesn' t hav e anythin g t o do wit hwhethe r yo

u tes t ra

w fue l o r no t somewhere . I t ha s t o d o wit hwhethe r yo u spen d a nawfu l lo t o f tim e an d energy looking a t testin g o f fuel s unde r the Clea nAi r Act . MS . GILHOOLEY : Well , I gues s par t o f i t i s th e jurisdictiona l point , an d I do wan t t o pursu e that . You r othe r poin t ther e i s tha t yo u shoul db e focusin g o

nemissions . Doe s tha t als o relat e t o ho w yo u d o th e test ? You'r e saying tha t EP A shoul d focu s o

nthe emission s fro

m fuels , an

d tha t sound s like , therefore ,
we shoul d be focusin g oninhalatio ntests , you know , ho w i t come s ou t o f th e tailpipe , t o judg e whethe r the existin g testin g i s adequate ?

MR . CAVALLI : I f a dat a gap existe dan d

a ninhalatio ntes t wa s the bes t mean s o f addressin g it , the ntha t woul d be ver y appropriate . I f a ninhalatio n tes t wa s no t th e bes t mean s o f approachin g it , the nw e woul d wan t you t o tes t th e bes t way . Ther e wil l b e occasion s whe na

ninhalatio ntes t wil l probabl y no t
answe r th e questio ntha t we bot hhave .

MS . GILHOOLEY : Th e othe r poin t tha t you


### 6 0P.6 2

L . J wer e raising , I guess , i s thi s jurisdictiona l on e tha t

w a s i nyou r testimon y too . I gues s yo u wer e sayin g tha t EP A shoul dfocu s o nth e hazards , th e effec t o nth e Clea n Air , an d no t th e othe r potentia l toxicit y concern s tha t

ma y exis t wit hfuels , an d ther e hav e bee nconcern s raise dwit hsom e fuel s abou t poisonin g an d th e like . I tak e i t you r positio ni s tha t tha t woul dno t b e covere d b y thi s program ? I mean , we'r e goin g t o hav e t o loo k a t thi s further , an d I gues s 211(b ) i s writte nver y broadly . I s it , nonetheless , you r positio ntha t w e woul dnot , unde r thi s testin g program , loo k a t an y kin d

o f poisonin g effect s tha t peopl e ma y ge t fro m

fuel s whe n the y sypho ni t fro m

th e ga s tan k o r som e o f thes e othe r

concern s tha t wer e raise dabou t possibl e risk s fro m fuels ?
MR . DEAL : I' d like t o addres s tha t question . Tha t i s ou r position . We'r e ver y muc hawar e

o f th e jurisdictiona l issu e here , an d we'v e touche d o n i t inou r testimony . We'l l b e addressin g i t ina mor e fin e graine d way . I believ e wha t i t boil s dow nto , an

d le t th e recor d be clea r onthis , we'r e no t suggestin g tha t you shoul d be , an d we certainl y

ar e not , insensitiv e t o othe r healt heffect s tha t migh t b e

6 1P.6 3

L J associate d wit hfuels . Al l we'r e sayin g her e is , recognizin g th e contex t here , thi s particula r rule making , th e contex t i s th e Clea nAi r Act , th e contex t i s fuels . We think i t woul d be a mistak e a s a publi c polic y matte r an

d als o reall y

beyon d the EPA' s jurisdiction , t o turn211(b ) int o a nomnibus , for-all purpose s testin g provision .

W e think ther e ar e othe r statute s an d othe r processe s i nplac e whic hcanroun d ou t th e univers e o f testin g tha t migh t b e necessary . We loo k a t th e Clea nAi r Ac t an d Sectio n21 1 a s being relate dto , a s being focuse d o nai r quality , no t onl y huma nhealt h effects , bu t welfar e effects , an d ina nindirec t way , looking a t the effect s o nemissio ncontro l technology . I t seem s t o u s tha t i f you loo k a t the totalit y

o f Sectio n211 , it' s clea r EP A ha s broa d authorit y

unde r 211 , bu t i t seem s als o clea r t o u s tha t tha t authorit y

ha s som

e sideboard s onit . I t i s focuse d

onemissions , whethe r the y be evaporativ e o r whethe r they be tailpip e emissions , an d w e think tha t them e i s prett y stron g i

nSectio n211 . We'l l be addressin g thi s i na lo t o f detai1 .

I gues s the othe r sid e o f the coin , apar t fro

m th e lega l jurisdictiona l part , we think i t



### 6 2P.6 4

u J make s good sens e t o loo k a t i t tha t wa

y becaus e we'r e
no t talkin g abou t a situatio nwher e i f EP A doesn' t loo

k

a t th e whol e univers e o f testin g unde r 211 , non e o f tha t testin g canbe don e o r wil l b e done . We thin

k that' s jus t no t true . TSC A alread

y exist s an

d complement s Sectio n211(b ) ver y nicely . That' s reall y ou r proposition . MR . CAVALLI : I thin k a quic k loo

k a t a typica l unleade d gasolin e materia l safet y dat a shee t wil l sho

w yo u tha t a good dea l o f the kind s o f thing s you'v e expresse d concer nabou t hav e bee ndon e an dar e being done . MS . GILHOOLEY : Well , we'l l loo k a t thi s further , becaus e 211(b ) b y itsel f i s writte nbroadly , s o we'l l hav e t o loo k a t that . I gues s yo

u als o talke d abou t ho w it' s importan t tha t i f fuel s ar e essentiall y th e same , the

y shoul d be grouped , an d w e shouldn' t hav e duplicativ e testing . It' s on e o f the factor s i nth e ANP Rtha t EP A raise s an

d ask s abou t criteri a fo r judgin g that . On e possibilit y

i s t o loo

k a t th e substantiall y simila r criteria . Bu t I think on e o f th e thing s tha t woul db e usefu l t o have i s an y informatio ntha t woul d toxicologi cal ! y give u s informatio nonho w you mak e thes e


### 6 3P.6 5

L J comparisons . Doe s AP I have an y additiona l informatio n t o suppl y

o nthat , i f the

y coul d give i t toda y o r suppl y i t i nthe comments ?

MR . CAVALLI : I think wha t we'v e said , yo u mus t realiz e that , I kno w whil e yo

u wer e workin g unde r som

e tim e constraints , w

e wer e workin g unde r a n
eve ngreate r tim

e constrain t thanyo u were . Ther e i s a grea t dea l o f analytica l informatio navailabl e an da grea t dea l mor e forthcomin g o nthe subjec t o f emissions , bot hevaporativ e an d tailpipe . Wher e we ar e a t th e
momen t i s tha t we woul d certainl y start , I think , i n looking a t a fue l unde r th e Clea nAi r Act , let' s mak e a n assumptio ntha t w e canestablis htha t we do kno w some thing abou t the healt heffect s o f the curren t kind s o f emission s tha t we ge t fro m the curren t kind s o f fuel s tha t ar e i

nus e i

nthi s country , th e biggies , gasolin e

an d diesel . W

e have , yo

u know , a fairl y

goodide a o f wha t thei r emission s spectru m look s like , an

d w e kno w i t contain s benzene , an d w e kno w i t contain s polynuclear aromati c hydrocarbons , an d we kno

w somethin g abou t ho w much , an

d wha t th e rang e fro m eac hautomobil e is . W e kno w a nenormou s amoun t abou t ho w muc ho f tha t end s u p



### 6 4P.6 6



## ~ l j i nthe ambien t ai r a fe w fee t awa

y fro m a nautomobil e o r truck , bu t we have a ne w fuel , o r a differen t fuel , a reformulate d gasoline , fo r example . We woul d look a t the emission s spectru m w e expecte d fro

m tha t fuel , evaporativ e a s wel l a s tailpipe , an d i f ther e ar e no bi g difference s i

nthose , an

d I realize , bi g differences , ha s t o b

e defined , an

d I can' t defin e tha t fo r yo u today , bu t the nI think on e woul d be i na positio nt o argu e tha t fro

m a Clea nAi r Ac t perspectiv e thes e tw o fuel s wer e the same , regardles s o f th e compositio no f the origina l fuel .

Tha t migh t no t b

e th e cas e unde r TSCA . Yo u wouldn' t writ e a nunleade d gasolin e MSD S fo r tha t substance , bu t fro m the poin t o f vie w o f th e Clea nAi r Act , yo

u woul d hav e a simila r substance . Doe s tha t help ? MS . GILHOOLEY : Well , I tak e i t wha t you'r e sayin g is , loo k a t the emission s t o come ou t an d

se e ho w simila r they

are ? MR . CAVALLI : Yes , becaus e the emissions , whic hi s ou r concer nunde r th e Clea nAi r Act , i s a produc t o f fue l evaporativ e emission s control , combustio nprocess , an d exhaus t treatment , an d thos e ar e al l controllabl e variables . Fue l i s onl y on e componen t



### 6 5P.6 7

L J 

### o f th e emissions , an d a s we ge t mor e sophisticated , i t
ma yeve n become a mino r one .

MR . GRAY : I hop e tha t a s you prepar e you r detaile d comments , you wil l look a t th e scop e o f th e specifications , i f you will , fo r perhap s bas e fuel s
an d fue l additive s tha t you thin k migh t be clos e t o qualifying , o r tha t you thin k migh t qualif yunde r a progra mlik e thi s eve n righ t of f th e starting line . Certainly , th e rang e o f specifications , th e broade r the range , th e mor e tha t woul d o f cours e be o f concern , an d the greate r th e burde n fo r providing confidenc e tha t broadening thos e range s won' t introduc e component s tha t migh t pos e informatio n gap s tha t you otherwis e woul d b e arguing aren' t there .

So , i f you coul d hel p u s i n term s o f the proces s b

ymayb e addressing wha t fuel s an d fue l additive s yo u thin

k migh t already , a s I thin k some o f your comment s hav e suggested , be so-calle d bas e fuel s o r fue l additives . Th e comments , specificall yfro mD u Pont , fo r example , tha t th e fue l additive s hav e a tent h
o f a weigh t o f volume percen t o f an ycompound , you know , onl ycompose d o f th e fou r element s mentioned , coul d be a prett ybroad rang e o f compounds . Mayb e in your detaile d comment s you coul d addres s howbroad th e rang e o f


### 6 6P.6 8



### '— 1 L. J specificatio nshoul d be t o reall y hav e hig

hconfidenc e that- a ne

w materia l mad e tha t meet s the sam e specification s won' t pos e an y ne w environmenta l risk . MR . LEVINE : Le t m e sa y somethin g o

n that , Charles . Wit hthe oi l aut o tes t progra m we ar e looking a t a broad rang e o f fue l compositions , fo r example , looking a t aromati c solubles , 4 5 percen t an d2 0 percent , an

d w e have , o r w

e wil l have , speciate dexhaus t fro m thos e tw

o type s o f fuels , an d we canse e the n whethe r the exhaus t component s loo k lik e relativ e t o wha t i s a very , ver y broad rang e o f aromatics , o r 9 0 percen t poin t o r whatever , al l the mai ncompositiona l factor s o f fuel . So , I think we'l l be abl e t o narro w tha t down , an

d we'l l provid e that , obviously . Infact , whil e EP

A participate s i

nthe oi l aut o scene , youwil l hav e that . Additionally , mayb e t o answe r on e othe r questio nearlier , voluntee r wor k fo r th e AP I staf f wil l obviousl y

provid e yo

u wit hth e cite s o f al l the existin g dat a tha t we kno

w of , an

d a lo t o f i t you alread y have becaus e w

e shar e tha t wit hyou o r other s shar e i t wit h you . I mean , the vas t bod y o f dat a that' s there , I think bot ho f u s kno w mos t al l o f it . AP I plan s t o writ e extensiv e comment s an d wil l provid e that .
6 7P.6 9

~ l J 

### MR . GRAY : I thin k th e reques t wa s jus t t o be sur e tha t appropriat e cite s wer e give n in your statemen t fo r th e record o f thes e proceedings , t o be
sur e tha t th e record o f thes e proceeding s reflecte d thi s larg e bod

yo f information . I thin k i t woul d be par t o f
an ysuggestio n tha t you woul d hav e that , fo r example , gasolin e migh t be a bas e fuel , becaus e o f al l thi s information . I f th e AP I o r EP Acoul d identif yanothe r reall yimportan t test , we' d probabl ybe , on e o r th e other , working on i t now .

So , w e recognize , I think , some commo n
sens e kin

d o f parameter s bu t nonetheles s hav e t o hav e a thoroug h proces s her e t o both , you know , defin e whethe r it' s sufficien t an

d wha t sufficien t informatio n i s in th e contex t o f thi s requirement , an d then , howbroadl y th e specificatio n fo r tha t fue l o r fue l additiv e shoul d be , suc h tha t w e can hav e reasonabl e confidenc e tha t you r databas e tha t you'r e comfortabl e wit h cover s an y ne w developmen t withi n tha t specification .

I n th e contex t o f whe n thes e provision s
wer e being drafted , ther e wa s muc h discussio n abou t syntheti c fuel s fro mshal e an

d coa l an

d quit e a bi t o f
concer n abou t potentiall ynewenvironmenta l ris k fro m fuels , an

d yet , I woul d imagin e a distillat e fro mshal e

6 8P.7 0

migh t hav e som

e o f the sam

e properties , bu t migh t caus e
ne w concern s environmentall y a s well . So , it' s importan t tha t w

e se t u

p a good framewor k her e that' s bot hreasonabl e bu t ye t satisfie s the obligatio no f insuring tha t ther e aren't , especiall y new , problem s introduced , an

d t o d o tha t w

e have t o establis hthi s bas e concept , we think .

Again , t o the exten t tha t your comment s
cangive u s specifi c idea s o nthes e topics , I thin k the bette r we'l l be abl e t o fin d a proposa l an

d g o ahead , an d I loo

k forwar d t o that .

An y mor e questions ? Thank yo

u very much . I think th e Moto r Vehicl e Manufacturer s Associatio ni s next .

We have a reques t fo r a five minut e break . I f there' s no objection , we'l l do that .

(Proceeding s recessed. ) Mr . GRAY : Mr . Halberstadt , i f you'r e ready , I think we canbegin .

MR . HALBERSTADT : Thank you , Mr . Chairman ; m

y name i s Marce l Halberstadt . I' m Directo r
o f th e Environmenta l Departmen t onMVM A staff . Th e member s o f th e Moto r Vehicl e Manufacturer s Associatio n


### 6 9P.7 1

manufactur e 9 4 percen t o f the cars , truck s an d buse s buil t i

nthe Unite d States , an d thos e member s ar e listed i nth e statemen t whic hI'v e mad e availabl e fo r the record . MVM A appreciate s the opportunit y t o
commen t o

nthe Agency' s ANPR M onfuel s an

d fue l additiv e registration , a s publishe d i nthe Augus t 7 Federa l Register . Intha t notic e EP A announce d it s inten t t o develo p regulation s an d establis hprogra m protocol s an

d tes t procedure s relate d t o the testin g o f moto r vehicl e fuel s an

d fue l additive s fo r purpose s o f registratio na s prescribe d i

nSection s 211(b ) an d (e ) o f the Clea nAi r Act . The regulation s ar e t o provid e fo r test s t o determin e potentia l publi c healt heffect s an d suc hothe r informatio na s i s reasonabl e an d necessar y

t o determin e emission s contro l syste m effect s an

d welfar e impacts . M y brie f remark s wil l b e confine d t o emissio ncontro l syste m effects . It' s clea r fro m the reading o f the Advanc e Notic e o f Propose d Rulemakin g an d Sectio n21 1 o f th e Clea nAi r Ac t tha t the requiremen t fo r determinin g th e publi c health , welfare , an d emissio ncontro l syste m effect s o f fuel s an d fue l additive s mus t b e fulfille db

y th e fue l an

d fue l additiv e manufacturers . MVM A believe s



### 7 0P.7 2

thi s responsibilit y shoul d remai nwit hthe fue l an dfue l additiv e maker s unde r the ne w protocol s an

d procedure s establishe d b

y EPA . Requirement s fo r testin g o f effect s o f fuel s an

d fue l additive s o nemissio ncontro l system s shoul d be a s rigorou s a s thos e presentl y require dfo r vehicl e certification . Thi s i s especiall y critica l because , unde r the propose d ne w Clea nAi r Ac t Amendments , vehicl e manufacturer s wil l b e require dt o buil d vehicle s tha t mee t ver y stringen t emission s standards . Vehicl e manufacturer s mus t b e assure dtha t
an y fue l o r fue l additiv e wil l no t compromis e th e manufacturer' s abilit y t o mee t thos e standards . Testin g requirement s mus t als o asses s the impac t o f fuel s an d fue l additive s onlong-ter m durabilit y

o f emissio ncontro l systems . Vehicl e manufacturer s currentl y ar e responsibl e fo r th e in-us e durabilit y

o f emissio ncontro l system s fo r 50,00 0 mile s fo r passenge r car s an d 120,00 0 mile s fo r light-dut y trucks . Fo r cars , thi s i s likel y t o b e increase dt o 100,00 0 mile s wit hth e Clea nAi r Ac t amendments . Fuel s
o r fue l additive s whic hundermin e th e integrit y o f emissio ncontro l system s designe d t o perfor m fo r the require d in-us e perio d mus t no t b e approved . In


### 7 1P.7 3

I 1 L . J 

### addition , testing o f contro l systemeffect s mus t includ e
a statisticall ysignifican t sampl e o f vehicl e system s
an d b e conducte d unde r appropriat e driving condition s t o be considere d valid .

It' s als o importan t tha t th e dat a an d informatio n generate d fro mtesting fue l an

d fue l additiv e effect s on emissio n contro l system s be availabl e fo r publi c review , a s i s presentl ydon e fo r fue l additiv e waive r applications . I migh t mentio n here , in tota l concurrenc e wit h th e AP I testimony , tha t th e Moto r Vehicl e Manufacturer s ar e jus t a s optimisti c tha t th e aut o oi l researc h progra mwil l provid e informa

tio n t o th e Agencywhic h i s going t o be absolutel y invaluabl e an

d crucia l t o some o f thes e determinations . Th e publi c reviewo f thi s informatio n i s importan t because , a s th e designer s an d producer s o f th e systems , vehicl e manufacturer s ar e in a uniqu e positio n t o understan

d bes t th e implication s an d result s o f th e testing protocol s an d th e results . I woul d als o lik e t o mentio n tha t we ar e
concerne d abou t applicatio n o f the , substantiall y similar , claus e an

d urg e tha t i t no t be interprete d to o broadl ybecaus e o f th e potentia l effect s on emissio n contro l systems .
7 2P.7 4



### J Insummary , MVM A support s the need fo r regulation s t o establis hfue l an d fue l additiv e effect s
o nemissio ncontro l systems . Testin g mus t b e conducte d i na statisticall y vali d an

d appropriat e protocol , wit h opportunit y

fo r publi c review , evaluatio nan d assessmen t
o f tes t results . MVM A favor s the us e o f fue l additive s tha t canprovid e consume r benefit s suc ha s improvedfue l quality , improve d engin e performanc e an d durability , reduce d deterioratio no f emissio ncontro l system s an d increase d fue l supplies . However , fue l additive s mus t
no t adversel y

affec t the emissio ncontro l performanc e
an d mus t no t unreasonabl y increas e th e public' s exposur e t o potentiall y

harmfu l emissions . Tha t conclude s m

y statement , Mr . Chairman , an

d I wil l tr

y t o answe r you r questions . MR . GRAY : You r comment s see m t o focu s exclusively , excep t fo r th e las t sentence , on manufacturer' s liabilit y fo r the regulate d emission s an d probabl y

i nparticula r concer nabou t recal l implication s
o f differen t fuel s an d fue l additives , i s tha t correct ? MR . HALBERSTADT : I t i s th e manufacturers ' positio ntha t an y ne w fuel s o r fue l additive s mus t no t adversel y affec t th e emissio ncontro l system s i

nuse . So , certainl y recal l i s on e o f the



### 7 3P.7 5



### potentia l considerations , bu t in genera l a s vehicle s ar e buil t an

d certified , th e manufacturer s mus t be abl e t o anticipat e tha t th e emissio n contro l system s wil l no t be adversel yaffecte d b ythe fuel s an

d th e additives . MR . GRAY : Howd o yo u se e th e waive r provision s tha t you mentione d i n you r comment s inter

acting wit h regulation s tha t migh t be adopte d here , sinc e th e larg e focu s i s ofte n on th e effec t on the regulate d emission s unde r th e waive r process ? I s tha t
no t sufficien t fo r th e typ e o f concern s tha t yo u expresse d in you r statement ?

MR . HALBERSTADT : I t ma ybe . We'r e no t absolutel ycertain . Fo r example , th e ver yimportan t questio n i s raise d in th e ANPR M abou t wha t migh t constitut e a bas e fue l o r bas e fue l additiv e combina

tion , an

d whil e we'v e ha

d extensiv e discussion s on th e subject , we'r e no t absolutel ysur e wha t migh t constitut e
suc h a bas e lin e system . So , I' mno t reall yprepare d t o answer you r specifi c questio n righ t now , eve n though w e share your concern .

MR . GRAY : I s th e concer n that , fo r example , o n th e fue l side , th e bas e fue l migh t b e define d t o hav e a broade r rang e o f specification s than the , substantiall ysimilar , gasolin e typ e rul e that' s

7 4P.7 6



## " 1 used in th e waive r process ? MR . HALBERSTADT : Tha t woul d appea r t o be a possibility . W e fee l tha t an yfue l that' s adopte d
an d interprete d t o be a bas e lin e fuel , o r i t wil l mor e likel ybe a fue l an d fue l additive s package , mus t no t hav e advers e affect s on th e emissio n contro l system . Beyon d that , th e requirements , well , le t m e jus t sto p a t thi s point . I' mno t certai n I gras p the essenc e o f wha t you'r e trying t o ask .

MR . GRAY : Th e questio n is , relativ e t o th e concern s you expresse d in you r statement , wh yisn' t th e waive r proces s sufficien t t o guard agains t thes e
concerns ? MR . HALBERSTADT : Th e waive r process , a s I understan

d it , applie s t o newadditive s o r t o fuel s whic h ma

yno t be substantiall ysimila r t o what' s alread y available . I f indeed th e implementatio n o f thi s rul e
wer e t o concentrat e o n thos e particula r chemica l systems , the n I don' t believ e w e woul d hav e an ycon cerns . Tha t is , th e presen t systemin plac e i s working quit e adequately .

Ou r concer n i s whethe r th e Agency , through thi s process , migh t identif yfue l an d fue l additiv e system s tha t ar e no t covere d unde r th e 211(f )

7 5P.7 7



### Section , whic h the n woul d caus e u s concern . Tha t is , i f fo r some reaso n fuel s tha t ar e presentl yadequat e i n ewery wa ywer e t o be identifie d a s potentiall ycausin g problems , the n w e woul d rever t t o th e concern s expresse d i n m ystatemen t about , a t leas t a s fa r a s the effect s on th e emissio n contro l system s ar e concerned .

MR . GRAY : Ar e you concerne d tha t ther e coul d be unleade d gasolin e specification s tha t coul d exis t unde r the , substantiall ysimilar , rulin g tha t migh t hav e significan t advers e effect s on th e in-us e performanc e o f your vehicles , i s tha t it ?

MR . HALBERSTADT : W e believ e tha t unde r
a ver ybroad , possibl ya ver ybroad interpretatio n o f th e term , substantiall ysimilar , tha t sufficien t change s migh t creep int o th e fue l tha t hav e advers e effect s on th e exhaus t control , emissio n contro l systems , woul d become evident , MR . GRAY : So , your concer n i s tha t th e waive r process , becaus e o f th e flexibilit yunder , substantiall ysimilar , a s it' s nowdefined , ma ybe to o broad an

d tha t thi s rulemaking perhap s shoul d in-dept h establis h mor e stringen t o r restrictiv e restriction s on th e definitio n of , substantiall ysimilar , gasolines ?

I' mtrying t o bette r understan d ho wwe


### 7 6P.7 8

"~ l

. J canus e thi s concer ni ndevelopin g the proposa l b y trying t o understand wha t w e need t o b

e fixin g tha t migh t no t b

e workin g wel l wit hth e curren t process , becaus e the mai nfocu s o f you r comment s deal s with , i t appears , regulate d emission s an d manufacturer' s liability , no t the toxic , unregulate d typ e emission s tha t i s the othe r par t o f the issu e tha t we'r e focusing
on . MR . HALBERSTADT : Well , a s I mentione d

a t the outset , i t wa s no t m y inten t t o tal k abou t the healt heffect s portio no f th e ANPRM , an d perhap s the wa

y I state d m

y concer nabou t the interpretatio no f the , substantiall y

similar , claus e wa s misleading . I ha dn o intentio no f raising a poin t abou t a portio no f the syste m whic hi s workin g ver y wel l righ t now . I di d wan t t o mentio nthe concer ni nconnectio nwit hthe recom mendatio ni

nth e ANPR

M concernin g the groupin g o f chemical s o f substance s an d the interpretatio no f wha t migh t constitut e simila r fuel s a s they presentl y

exis t
an d a s they

migh t be develope d i nth e future . For thi s reasonI reall y raise d thi s cautio nflag , inthe sens e tha t i f the substantiall y simila r claus e wer e interprete d to o broadl y i nterm s o f groupin g fuel s o r fue l additiv e combinations , we migh t



### 7 7P.7 9



### leave th e real mo f something whic h i s acceptable , tha t is , something whic h cause s n o advers e affect s on the emissio n contro l systems , int o a combinatio n which , eve n thoug h chemicall yappear s ver ysimila r t o th e original , migh t caus e some deterioratio n o f th e emissio n contro l systems . MR . GRAY : So , in essenc e your suggestio n i s tha t t o keep ou r eye s open . Th e proces s shoul d hav e sufficien t safeguard s t o assur e tha t som e
newfue l o r fue l additive , eve n thoug h i t migh t qualify , fo r example , under , substantiall ysimilar , unde r th e waive r process , tha t i t stil l migh t hav e a n advers e affec t on the in-us e performanc e o f th e emissio n contro l system s a s the

yrelat e t o th e regulate d emission s an d manufacturer' s responsibilities . I n essenc e that' s the thing you'r e asking u s t o do ?

MR . HALBERSTADT : Yes . MR . GRAY : An

yquestions ? MS . KRUEGER : D o yo u hav e an ypropose d idea s fo r th e tiere d approac h fo r assessing emissio n contro l effects , an d i f so , I woul d encourag e you t o submi t thos e in writing .

MR . HALBERSTADT : Okay , onc e again , we'r e considering th e submissio n o f comment s on some

7 8P.8 0

"" I J othe r portion s o f the ANPR M i nwritin g fo r the record , an d w e wil l includ e your suggestion .

MR . GRAY : Thank yo u ver y much . MR . HALBERSTADT : Thank you . MR . GRAY : Th e las t schedule d testimon y wil l com

e fro m CMA/Exxo nChemical ; Mr . Keller . MR . KELLER : Thank you ; i nthe interes t
o f saving time , I wil l no t b e reading th e ful l statemen t
a s yo u hav e printe d infron t o f you . I'l l be skippin g throughsom

e section s an

d skippin g som

e paragraph s entirely . I'l l tr y t o kee p thi s possibl y t o a 1 2 o'cloc k conclusion .

M y nam e i s Dr . Charli e Keller , an dI' m her e today

representin g the Chemica l Manufacturer s Association , Petroleu m Additive s Panel . Thi s pane l represent s a group o f majo r manufacturer s o f fue l an d lubrican t additiv e components , an d th e companie s represente d o

nthi s pane l ar e Amoc o Petroleu m Additive s Company , Lubrizo l Petroleu m Chemica l Company , the Ethy l Corporation , th e Oronit e Divisio no f Chevro nChemica l Company , the Paramin s Divisio no f ExxonChemica l Company , Texac o Chemica l Company , an d Mobi l Chemica l Company , A s a parenthetica l note , m y comment s



### 7 9P.8 1



### toda yar e goin

g t o focu s almos t entirel yon th e impac t
o f thi s rul e on fue l additive s a s fue l additives , a s oppose d t o fue l additive s in combinatio n wit h hydro

carbo n fuels . So , our perspectiv e ma ybe a littl e bi t differen t than , fo r instance , tha t o f th e American Petroleu

mInstitute , bu t th e perspectiv e i s differen t onl ybecaus e we'r e focusing on on e par t o f th e issue , rathe r than muc h broade r issues , I think , whic h ar e raise d i

n th e ANPRM .

Fue l additive s ar e specialt ychemical s whic h ar 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 o r diese l fuels . They'r e critica l t o th e operatio n o f moder n emission-controlle d engines . Theyac t a s antioxidants . Ver

yimportantly , the

ypreven t fue l injecto r fouling ; the yreduc 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 y critica l t o maintaining engin e emissio n contro l in
recen t years , an

d I thin

k w e se e tha t i

n advertising campaign s eve n an

d concern s raise d b ymoto r vehicl e manufacturers . Now , whil e there' s a genera l tendenc y
among th e genera l publi c t o vie wchemical s a s


### 8 0P.8 2



### environmentall yharmful , ou r industry , an d i n particula r thi s CM Agroup , feel s tha t w e produc e fue l additiv e chemical s whic h hav e mad e substantia l contribution s t o maintaining lo

wemission s in moder n engines . I n th e ANPRM , EP

Astate d tha t ther e ar e currentl y3,79 0 activ e registration s fo r fue l additives . Now , no t al l thes e
ar e distinctl ydifferen t products , a s I' msur e EP A recognizes , bu t w e believ e tha t thi s ver ylarg e numbe r reflect s th e dynami c an d innovativ e natur e o f fue l additives . W e fee l th e industr yha s worke d ver

yhar d i n
recen t year s an

d spen t considerabl e researc h an d developmen t moneyt o mee t the challenge s o f fue l system s
an d engine s whic h ar e nowmuc h mor e sensitiv e t o deposi t formation . I gues s wha t we'r e trying t o sa yi s tha t we thin k we'r e par t o f th e solution , no t par t o f th e problem . Now , th e ANPR M raise s a ver

ylarg e numbe r o f question s an d unresolve d issues , man yo f whic h affec t fue l additives . Th e issue s an d question s raise d includ e comple x technica l issue s on emission s an d toxicolog

ytesting , a s wel l a s some 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 existing EP Aregulation s an

d ultimatel yt o amendment s t o th e Clea n Ai r Act , whic h we


### 8 1P.8 3

u J 

### expec t i n thi s ter

mo f Congress . Fo r example , jus t t o focu s on on e thing , w e believ e tha t th e ANPR M suggest s toxicit ytesting whic h woul d probabl yg o beyon d th e limit s o f establishe d methodolog

yan d technology . Whil e ther e ha s bee n toxicit ytesting o f combustio n emissions , an d I thin

k AP I ha s note d tha t quit e well , thi s testing ha s no t encompasse d th e ful l an d broad spectru

mo f endpoint s th e ANPR M identified . Furthermore , in ou r opinio n thi s testing ha s bee n directe d a t answering wha t woul d appea r t o be ver

ynarrowresearc h questions . A n importan t technica l aspec t o f thi s problemi s th e selectio n o f a n appropriat e baselin e t o compar e an

d asses s th e toxicit yo f emission s fro m new fue l an d additiv e combinations . Now , in jus t a casua l vie wo f this , an

d w e haven' t don e an yin-detai l analysis , w e thin

k i t coul d probabl ytak e year s an d million s o f dollar s jus t t o develop an d validat e a baselin e procedur e an d set s o f protocol s fo r testing combustio n emission s i n a n inhalatio n toxicit ytest , fo r example . Now , in additio n t o variabilit yissues , statistica l variabilit yin emissions , anothe r technica l problemi s definitio n an d contro l o f variabilit yi n
8 2P.8 4

L J 

### anima l response . Tha t ha s bee n a problemi n othe r tests , a s I' msur e EP Arecognizes , an

d thi s woul d be reall ya neware a o f comparativ e testing . W e believ e tha t developing an

d validating suc h tes t standard s fo r emission s toxicit ytesting woul d requir e a massiv e effor t o n EPA' s par t an d consequently , I think , o n the par t o f th e regulate d industry .

Beyon d th e example s I'v

e jus t cited , we believ e ther e ar e probabl ya lo t o f othe r example s o f technica l o r practica l concern s whic h coul d presen t obstacle s t o th e testing progra menvisione d in th e ANPRM . W e recogniz e tha t EP Aface s a rea l challeng e i n sorting through thes e issue s t o develo p a focu s fo r your rulemaking , T o hel p focu s on a directio n fo r rulemaking , w e believ e it' s helpfu l t o examin e th e legislativ e debat e i n th e 197 0 an

d 197 7 Clea n Ai r Ac t Amendmen t process . I n thi s regard w e examine d some o f th e document s tha t you hav e in you r publi c docke t fo r th e rulemaking . A s you know , th e origina l 197 0 Clea n Ai r Ac t wa s in fac t a n amendmen t o f predecesso r provision s whic h wer e containe d in th e '6 7 Act . In 197 0 th e legislativ e debat e o n fuel s an d fue l additive s focuse d almos t exclusivel yon th e us e o f lea d compound s

8 3P.8 5

( — 

# ] a s anti-knoc k additives . However , i nou r revie

w o f the docke t w

e di d no t fin

d a singl e referenc e t o congressiona l concern s fo r an y specifi c fue l additive , othe r tha nlea

d anti-knoc k compounds . Inth e '7 7 Amendmen t process , congressiona l debat e wa s als o ver y narrowl y

focused . I

n 1977 , the fue l additiv e concern s o f Congres s focuse do n the us e o f the singl e additiv e chemical , an d ther e wa s
very limite d mentio no f concer nove r genera l us e o f fue l additives . Inaddition , i t appear s fro m som e congressiona l summarie s o f th e tim e a s thoughCongres s
wa s primaril y

intereste d i

nth e issu e o f fue l additiv e effect s o

nvehicl e emissio nsystems . A s you know , that' s include d i nSectio n211(b)(2)(B) . Ther e didn' t
seem , a s a commen t o r a nopinion , ther e didn' t see m t o be a lo t o f congressiona l concer ni nth e writte nrecor d

onhealt heffect s o f emissions . Despit e thes e apparen t
narro w concerns , Congres s added , a s yo u know , Sectio n 211(e ) t o th e Act , whic hi s your mandat e t o promulgat e regulation s unde r 211(b) . Th e 211(e ) mandat e an dthe 211(b ) testin g requirement s ar e quit e broa d inpotentia l scope , We believ e tha t EP A shoul d conside r thi s informatio ni

nth e docke t whic hi s relevan t t o th e 197 0



### 8 4P.8 6



### an d 197 7 Amendment s o f Sectio n 211 . I f EP Aagree s tha t Congres s focuse d onl yon a coupl e o f specifi c additiv e chemical s o f hig

h concer n t o the

man d als o o n combustio n emissions , the n thi s coul d serv e t o hel p you focu s your effort s i

n thi s rulemaking activity . Turning nowt o th e statutor yrequire

ment s in th e Clea n Ai r Act , th e 197 0 Ac t an d it s Amendment s di d no t provid e EP Awit h clea r direction s fo r rulemaking . Instead , EP Ai s give n grea t latitud e an d discretio n i

n regulating testing o f fuel s an d additives . I hav e her e th e relevan t section , on th e slide , fro m 211(b) . Th e importan t thin g her e is , I think , th e conditiona l phrase , ma yals o require , an

d w e believ e thi s i s critica l t o th e ANPR M an d th e rulemaking becaus e i t allows , an

d fo r tha t matte r eve n arguabl ymandates , tha t EP Autiliz e it s judgmen t in preparing th e regulation s require d unde r Sectio n 211(e) . A s note d i n th e ANPRM , th e legislativ e histor yo f th e '7 7 Amendment s indicate s Congress ' inten t tha t testing regulation s no t be undul yburdensome , an d tha t cost s shoul d als o be considered , T o us , th e ANPR M suggest s tha t EP

Ama y be interpreting the , ma yals o require , statutory
8 5P.8 7

L . J languag e t o mean , shal l require . At thi s stag e o f rulemaking , w

e believ e thi s emphasi s o nbroad-base d testin g i s somewha t premature . W e fee l tha t effective , mor e focuse d option s fo r healt han d environmenta l protection , whic hwoul d o f cours e includ e testing , ma y
no t hav e bee ngive nsufficien t consideratio na s yet .

W e believ e EP

A mus t focu s thei r rulemakin g t o mee t bot hthe legislativ e inten t an dthe statutory

languag e whic hmandate s som e reasonabl e judgment . Th e curren t ANPR M addresse s a very larg e numbe r o f ver

y broad issues , bu t doe s no t identif y specifi c environmental , health , o r publi c welfar e
concerns , o r problems . Thi s ma y soun d lik e a cynica l comment , bu t i

nsom e way s th e ANPR

M appear s t o be a solutio ni

nsearc ho f a problem . Th e possibilit y o f a
vas t scop e o f testing , o npossibl y

hundred s o r thousand s
o f products , raise s the dange r tha t thes e regulation s coul d needlessl y

disrup t the us e an d innovatio no f additive s wit hprove nvalu e i nth e reductio no f emissions . Th e potentia l cost s o f testin g coul deasil y lea d t o reduce d researc han d innovatio nan

d produc t withdrawal s fro

m th e market , withou t an y identifie d environmenta l benefit . We think tha t i nthi s case , tha t



### 8 6P.8 8

1— 1 L J there' s a cas e t o be made , thoughno t explici t i nthe statute , fo r som

e balancing o f cost s an d benefits , particularl y

whe nthe costs , i nterm s o f environmenta l harm , haven' t reall y beenidentifie d yet . EP A mus t asses s thei r objective s i nthi s rulemaking . Incontras t t o mos t EP A regulation s wit h highpotentia l impact , EP A ha s no t include d a regulatory analysi s o f thei r concern s an d possibl e options . I think we'r e sympatheti c t o EPA' s pligh t an d you r ver

y tigh t timetable , sinc e we'v e als o bee nface d wit ha tigh t timetabl e an d understand ho

w difficul t thi s issue i s o nthi s timetable . T o focu s rulemakin g onissue s o f

rea l concern , EP

A shoul d conduc t a thoroug hregulator y analysis . Thi s analysi s shoul d evaluat e whethe r combination s wit ha fue l caus e 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 concer n whic hi s no t being addresse d b y curren t EP

A o r perhap s OSH A regulations . Th e regulatory analysi s shoul d asses s existin g informatio no nfue l additive s t o determin e i f ther e i s sufficien t reasont o believ e tha t registere d additive s adversel y affec t combustio nemissions . The analysi s shoul d als o determin e ho w testin g dat a woul db e
used i nSectio n211(c ) regulatory actions .
8 7P.8 9



## J Finally , w e fee l it' s ver

y importan t tha t the analysi s examin e ho w the propose d regulation s relat e t o the 199 0 Clea nAi r Ac t Amendment s whic hwil l potentiall y

resul t i

nfundamenta l change s i nvehicl e fuels . I

nthe 199 0 Amendments , a s currentl y being discusse d i

nconferenc e committee , neithe r Sectio n 211(b ) no r (e ) provision s ar e changed . Ther e ar e propose d amendment s whic har e relevan t t o thi s ANPRM , however . Inparticular , bot hbills , the Senat e an dthe Hous e version , actuall y requir e the us e o f fue l additive s t o preven t the formatio no f deposit s i nfuel s systems . So , there' s beensom e recognitio nonCongress ' par t o f wha t I have sai d earlie r i nm y presentation . I n addition , CM

A believe s tha t fue l additive s wil l be a crucia l par t o f th e clea nfuel s approac ht o reducin g combustio nemissions . Finally , the 199 0 propose d Amendment s woul d furthe r limi t evaporativ e emission s durin g refuelin g an d fro m vehicles . Becaus e thi s wil l furthe r reduc e huma nan d environmenta l exposure , w e believ e thi s shoul d b e considere d b

y EP A i nthe rulemakin g i

nassessin g whethe r ther e i s a needfo r testin g o f liqui d fuel s an d fue l additives . Thi s lead s u s t o anothe r issu e whic hw e think i s ver

y important , whic hshoul d be addressed ,


### 8 8P.9 0

regarding the us e o f toxicit y testin g dat a whic hwoul d be generate d a s a resul t o f th e rul e develope d fro m thi s ANPRM . EP

A shoul d carefull y conside r ho

w toxicit y generate d b

y fue l an

d fue l additiv e manufacturer s woul d be usefu l t o EP

A i ncarryin g ou t thei r responsibilitie s unde r th e Clea nAi r Act . Th e ANPR M propose s broa d testin g o f fue l an d fue l additiv e products , ye t Sectio n 211(c ) o f the Ac t explicitl y authorize s EP

A t o regulat e fue l additive s onl y o nth e basi s o f advers e effect s o f emissions . Thi s i s supporte d b y th e legislativ e history containe d i

nth e EP

A docke t whic hsummarize s wha t ha d becom e the 211(e ) provision .

Sinc e EP

A lack s regulatory authorit y

t o regulat e onthe basi s o f non-emission s base d effects , i t woul d mak e littl e sens e t o u s t o requir e testin g t o evaluat e thes e potentia l effects .

Recognizin g tha t thes e potentia l effect s
ar e stil l a concern , w e believ e tha t th e toxicit y o f chemica l component s containe d i nfuel s an

d fue l additive s ar e alread y adequatel y

addresse d b

y th e Toxi c Substance s Contro l Act , o r TSCA . Ne w fue l additiv e chemical s introduce d sinc e 197 8 hav e bee nsubjec t t o EP A revie w an d hazar d assessmen t a s par t o f the Premanufacturin g Notificatio nprocess . Existin g fue l


### 8 9P.9 1



# n j additiv e chemical s are , o f course , subjec t t o potentia l regulatio nan

d testin g unde r Sectio n4 o f TSCA . In fact , EP

A ha s alread

y exercise d thi s authorit y i na t leas t on e case , i

nfac t mor e tha non e case , regarding MTBE , wher e there' s a ver y larg e scal e testin g progra m fo r MTBE , whos e primary us e i s i

nfuels . T o chang e gear s a littl e bit , tal k abou t th e matri xapproach , whil e w e woul d urg e EP

A t o re evaluat e thei r objective s an d t o focu s o

nwha t ma

y b e the ke y environmenta l issues , w e als o believ e tha t som e
o f th e concept s identifie d i nthe ANPR

M meri t furthe r consideration . We believ e tha t the tiere d matri x approac hi s on e o f these , an d i t ma

y offe r a potentiall y flexible , focuse d proces s t o identif y fue l an

d fue l additiv e combination s fo r whic hfurthe r emission s toxicit y

testin g ma

y be needed . However , we fee l tha t th e matrice s identifie d inth e ANPR M ar e no t optimall y structure d fo r decision-making , becaus e toxicit y testin g coul d be require d befor e ther e ha s bee nsufficien t analysi s an

d judgmen t exercise d t o determin e whethe r thi s testin g i s reall y necessar y

o r woul d eve nbe usefu l t o achievin g regulatory objective s unde r Sectio n211(c) . Inthi s regard , th e ANPR M note s tha t Congress ' approac hwa s t o mandat e a ris k assessmen t fo r


### 9 0P.9 2

L J potentia l advers e effect s o nhealth , welfare , an d emissio ncontro l systems .

W e strongl y

suppor t thi s approach . However , w

e questio nwhethe r th e proposa l t o us e productio nvolume a s a facto r i nth e ris k assessmen t i s reall y al l tha t valid . However , mos t importantly , w e fee l tha t th e ANPR M doe s no t sufficientl y conside r potentia l exposur e a s a majo r facto r i nthi s ris k equation . A s wit hman y chemicals , ver

y lo w exposur e potentia l ma

y negat e the need fo r toxicit y testin g i f ther e i s sufficien t information , including , fo r example , structur e activit y o r SA Rdata , t o asses s a combustio n emissions' s approximat e toxicity .

Turnin g no

w t o curren t regulations , we think thi s i s anothe r are a wher e som e link s needt o be made . We woul d suppor t linking thes e propose dregula tion s t o existin g fue l additiv e registratio nprocedure s base d uponthe , substantiall y similar , definitio nfo r fue l additives . We believ e the , substantiall y similar , provision s o f th e curren t registratio nproces s provide s
a workabl e mechanis m fo r reviewing an d registerin g additives . We think tha t thes e provision s ar e sufficien t fo r considerin g combustio nemissions , whic h

we fee l i s th e mos t importan t healt han d environmenta l



### 9 1P.9 3

concer nwhic hwa s raised i nth e ANPRM . 

### J Finally , t o dra w som e conclusion s fro m al l o f this , w

e believ e EP

A cansuccee d i

nthi s comple x rulemakin g i f i t follow s the statutor y mandat e whic h require s judgment , discretion , an d a focuse d approac hon potentia l healt han d environmenta l concerns . The ANPR M identifie d a wid e spectru m o f issues . Infact , I thin k yo u probabl y

covere d the vas t majorit y o f potentia l issue s an

d di d a good jobo f pullin g tha t togethe r i n the tim

e tha t yo

u had , bu t a t thi s poin t we woul dhop e tha t EP

A coul d no

w begi nt o focu s it s effor t t o develo p testin g regulation s fro m th e propose d regulations , whic h woul d addres s rea l concerns , consisten t wit hEPA' s regulatory

power s unde r Sectio n211(c) . An y regulatio n whic hindiscriminatel y require s broad testin g withou t regard t o thes e issue s o r concern s run s th e dange r o f causin g needles s disruptio nan d economi c hardshi p on producer s an

d consumers . A s I pointe d ou t earlier , w e 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 the problem . W e fee l th e regulation s shoul d reflec t this , an d EP A shoul d

no t jeopardiz e futur e additiv e innovation s whic hwil l benefi t th e environmen t an d whic hwil l b e necessar y fo r th e succes s o f clea nfuel s requirement s i nth e upcomin g



### 9 2P.9 4

'9 0 Amendments , CM A woul d like t o offe r EP A our assistanc e inprovidin g additiona l technica l informatio n i ndiscussin g wha t regulatory option s yo

u ma y have , wha t specifi c regulatory option s you ma

y have . However , w e believ e we coul d provid e muc hmor e usefu l informatio ni f th e commen t perio d wer e extende d anothe r 3 0 o r 6 0 days , t o provid e u s wit hmor e time . We' d lik e t o mak e the forma l reques t tha t EP A conside r extendin g th e docke t fo r writte ncomments .

Thank yo

u fo r thi s opportunit y t o presen t ou r views , an d we'r e very

hopefu l tha t w e ca n
wor k togethe r t o achiev e a productiv e outcome onthi s rulemaking . MR . GRAY : Thank you fo r you r statement , an d we als o loo

k forwar d t o continuin g t o wor k together . Althoug hmuc ho f you r statemen t focuse d o nwha t a t firs t you seeme d t o be characterizin g a s anEP A inten t t o seiz e al l th e opportunit y fo r the broa d authority , shapin g o f rulemaking , whic hi s a napparen t concer no f yours , bu t the nyou di d acknowledg e tha t th e mor e specifi c concep t tha t wa s propose d wa s th e tiere d concep t whic hwa s a nattemp t to , I think , respon dt o the kin d o f concern s tha t you raised , tha t th e statut e


### 9 3P.9 5

L . J coul d give a ver y broad impac t maybe , an d t o some , sugges t a ver

y broad se t o f testin g requirements , bu t i t
wa s a nattemp t t o propos e somethin g tha t coul d buil d uponexistin g informatio no f course .

Also , I think , an d tha t par t yo

u recognized , a ke

y t o tha t i s th e definitio no f the groupings , an

d yo u mentione d the , substantiall y similar , requirement s fo r gasolin e unde r the waive r process , bu t i nyou r introductory kin d o f descriptio no f you r association , i t seeme d t o b e principall y

fue l additive , mayb e exclusivel y fue l additiv e companies , an dI' m wonderin g ho

w yo u vie w fue l additive s unde r the , substantiall y

similar , definition ? Wha t kin d o f flexibilitie s doe s tha t give yo u now ? MR . KELLER : Becaus e I' m representin g a trad e association , I gues s I can' t spea k fo r eac ho f th e membe r companies . So , I'l l spea k i ngeneralities , fro m
m y perspectiv e inExxonChemical . I think the current , substantiall y

similar , provision s unde r th e curren t registratio nprocedure s offe r sufficien t flexibilit y an d

ar e realisti c i

nterm s o f thei r operation . Fro m ou r perspectiv e inExxo nChemical , I think w e fin dthe m quit e satisfactory .

MR . GRAY : Becaus e mos t fue l additive s

9 4P.9 6

I 1 1

_J 

### wer e eithe r alread yinclude d o r they'r e expecte d t o be basic , organic-typ e material s tha t woul d be included ?

MR . KELLER : Yes ; o f course , a s you know , ther e ar e exception s whic h the n woul d subjec t the m t o th e waive r process .

MR . GRAY : Right . MR . KELLER : Bu t wit h discussion s tha t

w e hav e ha

d withi n th e CM

Agroup , woul d no t indicat e tha t ther e i s an

ygenera l dissatisfactio n wit h th e wa y th e curren t registratio n procedure s ar e operating an d i n particula r wit h th e definitio n whic h you'v e provide d for , substantiall ysimilar .

MR . GRAY : I thin

k th e concer n tha t w e probabl ywoul d hav e t o explor e i s whethe r o r no t thoug h there' s to o muc h flexibilit ywit h regard t o howw e woul d be charge d t o implemen t thi s Sectio n o f course , an d the example s o f fue l o r fue l additive s tha t hav e bee n require d t o g o throug h waive r processe s o f eithe r inorgani c material s in gasolin e befor e o r th e additio n
o f substantia l amount s o f a ne worgani c material , an d i t allow s considerabl e flexibilit yin othe r organi c material s in lo

wconcentrations , lik e man yo f th e fue l additive s are , o f course .

So , I gues s t o th e exten t tha t w e can
9 5P.9 7



### "~ l 

## J categorize , perhap s mor e finely , organic-base d fue l additive s t o provid e mayb e mor e assurance s tha t ou r obligation s ar e bein g me t unde r thi s rulemaking , i f you could , i

n your follow-u

p comments , give u s mor e specifi c hel p on ho

ww e can d o that , I thin k tha t woul d b e ver y helpfu l t o us . MR . KELLER : I thin k w e can probabl yd o tha t in subsequen t writte n comments . Wha t we'v e suggeste d i s tha t the , substantiall ysimilar , provision s
ar e currentl yworking , an d working , in ou r view , quit e well , an

d tha t w e believ e tha t they'r e protectiv e o f environmenta l an

d healt h issues . They'r e a t leas t a good starting poin t fo r continuing th e assessment , an d I thin k you recogniz e tha t thi s i s a differen t rule , thi s i s a differen t rulemaking . Th e definitio n fro m 198 1 ma

y
nee d t o be re-looke d a t in term s o f th e objective s EP A ha s in thi s rulemaking an d th e mandat e unde r 211(b) . So , I thin

k wha t w e woul d sugges t is , tak e a hard look at , substantiall ysimilar , an d mayb e we ca nprovid e some additiona l information , an d some fine

tuning o f th e definitio n ma yo r ma yno t be appropriate . Bu t I thin

k tha t get s bac k t o th e genera l thrus t o f ou r presentatio n whic h is , th e importan t thing her e i s t o focu s reall yon wha t th e environmenta l healt h objective s
9 6P.9 8



### are , an d wher e th e bi g concern s are .

I thin k we'v e pointe d ou t tha t we woul d fee l tha t th e concern s ar e i n th e combustion/emission s
area , an

d a s AP I ha s pointe d out , there' s a tremendou s
amoun t o f informatio n an d wor k tha t hav e bee n don e on combustio n emissions , thoug h tha t wor k wa s no t specificall yfocused , a s you know , on issue s raised i n thi s rulemaking . Yo u can rea d tha t mas s o f informatio n
an d lear n a lo t abou t combustio n emission s an d wha t
concern s ther e migh t be fo r fuel s o r fue l additives . I thin k tha t informatio n reall yneed s t o be strongl y considere d an

d assesse d befor e you g o to o muc h furthe r in th e rulemaking process .

MS . GILHOOLEY : I ha d a questio n abou t th e exposur e leve l fro mth e fue l additives . There' s on e plac e in her e tha t you sa ytha t al l th e newfue l additive s woul d mee t th e TSC Acriteri a fo r hig

h exposur e chemicals . Th e earl ydiscussio n suggeste d tha t a lo t o f fue l additives , th e testimon yfro mD u Pont , wer e lo

w exposure . Coul d you explai n that ?

MR . KELLER : Yes , I skippe d through tha t in th e presentation . I t get s t o be prett ytechnical . Yo u have , on you r group , a n exper t on this , I know , s o I'l l hav e t o state , I guess , EPA' s hig h volume , hig

h

9 7P.9 9

exposur e policy . W e think exposur e i s low . However , i n the PM N proces s highvolum e product s ar e product s whic h woul d b

e manufacture d i

nquantitie s o f greate r tha n 100,00 0 kilogram s a year , o r fo r whic hther e woul db e exposur e t o greate r tha na thousand consumers , I believe , o r 25 0 worker s chronically . Th e number s ar e somethin g lik e that ; Heid i ma y have them . I nan y case , thos e ar e threshold s i nth e PM N revie w proces s whic htrigge r a mor e detaile devalua tiono f the PM

N submission . They don' t necessaril y trigge r testin g unde r a consen t orde r o r unde r a voluntar y

suspensio no f th e PM N period , bu t they do trigge r a close r EP A loo k a t the chemica l an d it s uses . W e fee l that , give nth e wa y fue l additive s ar e used , i nlo w concentration , i nproduct s tha t ar e going t o consumers , i ngenerall y

enclose duse s t o contro l fo r exposur e t o the hydrocarbo nsolvent s whic har e used , o r benzen e containin g gasoline , an d becaus e o f the lo w vapo r pressur e o f thes e fue l additive s ingeneral , a t leas t o f th e specialt y com ponents , tha t al l thes e thing s ten d t o sugges t tha t huma nexposur e t o the additive s throughmanufacturing , blending , distributio nan d consume r us e i

ngasoline s i s probabl y

very , very

low . I can' t cit e specifi c studies ,


### 9 8P. 1

I — I L J bu t w e think o

njus t sor t o f a commo nsense , quic k pass , surfac e vie

w o f this , i t woul d appea r that , i na ris k

assessmen t context , the exposur e i s going t o be prett y low . MS . GILHOOLEY : Including i nthe emission s fro

m th e car ? MR . KELLER : Well , I think that' s a n issue we'r e going t o have t o tak e a loo k a t i na lot
mor e detail , an

d that' s wh

y ou r comment s suggeste dtha t that' s wher e EP

A ough t t o be looking a s well , a t emission s effects . However , a s AP I ha s noted , there' s alread y a lo t ou t ther e tha t need s t o be lookedat .

I gues s m

y comment s onTSC

A an d high volume chemical s ha d t o d o onl y

wit hth e wa

y thes e chemical s ar e being reviewe d withi nEP A already , no t t o sugges t tha t EP

A woul d agre e o r disagre e wit hou r
assessmen t o f exposure . I' m sur e Heid i i s going t o wan t t o sa y somethin g now .

MS . SIEGELBAUM : Well , jus t t o clarif y
on e point , th e trigger s tha t Dr . Kelle r i s referrin g t o dea l primaril y

wit hwidespread , althoug hprobabl y ver y small , exposures , an d th e wa

y th e statut e i s writte nha s
a ney e toward s looking a t chroni c effect s ove r a lon g perio d o f time , bu t what' s happenin g no w i nth e PM

N

9 9P. 2



### L J progra ma t least , fo r the man ychemical s tha t mee t thi s exposure-base d criteria , afte r receivin g the bas e set , eithe r bot h healt h an d eco-toxicit ydat a ar e dropping
ou t o f furthe r review , you'l l be happ yt o note . MR . KELLER : Good . MS . SIEGELBAUM : So , we'r e finding tha t th e acute s ar e coming u p negative , therefore , no t necessitating an

yfurthe r chroni c testing , o r sub

chroni c testing . MR . KELLER : I thin k it' s als o importan t t o remembe r tha t th e statutor ypower s unde r TSC

Aar e quit e broa

d an d quit e powerful , muc h mor e powerfu l an d
muc h broade r than thos e in 211(b) , an d s o unde r th e PM

N process , EP

Aha s grea t power s t o regulat e an d restrict . MS . SIEGELBAUM : I thin k your previou s point s ar e ver

ywel l take n abou t circumscribing thes e regulation s t o tak e int o accoun t th e othe r regulator y initiative s tha t ar e bein g taken , primaril yunde r TSCA , in bot hth e ne

wchemical s progra

mt o a lesse r extent , an d perhap s mor e significantl yunde r th e existing chemical s progra

min regard s t o tes t rules . I thin k tha t on e o f th e bi g challenge s fo r th e Agenc ywil l be coordinating thos e efforts , whic h i s sometime s fairl y difficult , t o tak e int o consideratio n th e result s fro m


### 10 0P. 3

I 1 L _ l 

### NT P an d othe r studie s tha t ar e being conducte d on the TSCA

- sid e an

d usin g thos e u

p fron t t o hel p mor e finel y tailo r thes e regulation s s o they'r e no t overbroa d an d
ou t o f th e scop e o f 211(b) . So , you ca n hel p u s work on that . MS . GILHOOLEY : I gues s you als o mentione d something abou t using th e structur e activit y relationshi p a s a wa yt o ge t a combustio n emission s approximat e toxicity , a s a wa yt o asses s it . Yo u di d tha t i n th e contex t o f talking abou t lo wexposur e levels . I s tha t something tha t coul d als o be use d i n determining whethe r something i s substantiall ysimilar , o r whethe r you shoul d grou p something ? MR . KELLER : Yes , I thin k you can . I thin k that' s reall yth e basi s o f EPA' s 198 1 interpretiv e guidelin e on , substantiall ysimilar . Withou t goin g int o
a lo t o f detai l in th e statement , I wante d t o rais e structur e activit yrelationship s a s a vali d wa yt o asses s no t onl yanima l toxicit yo r human healt h
concerns , bu t als o concern s ove r emissio n o r combustio n products . I thin

k it' s kin

d o f a usefu l concep t t o buil d int o you r tiere d matri x approach . I thin k i t need s some mor e though t an d some polishing u

p an d some specifi c detail s adde d t o it , bu t I thin k it' s a concep t

10 1P. 4



## "" I L . J 

### tha t ough t t o be there . MS . GILHOOLEY : I gues s jus t on e las t
one . I gues s you talke d a lo t abou t th e legislative history , whic h I' msur e wil l be ver yuseful . In your comment s I gues s you'l l tal k abou t th e legislativ e histor yo f th e 197 7 additio n o f 211(e ) an d it s concern s abou t making sur e tha t ther e i s enough testing ?

MR . KELLER : Yes , again , tha t debat e i n '7 7 wa s prett ynarrowl yfocuse d on on e additiv e in particular . I think , withou t criticizing Congres s to o much , it' s no t clea r tha t in 197 0 o r 197 7 theyreall y understoo d fue l additives . Having deal t wit h themi n 198 7 in subcommittee , I knowtha t in 1987 , tha t th e member s o f tha t subcommitte e certainl ydidn' t understan d fue l additives . I t too k u s a littl e whil e t o educat e them , bu t I thin

k the yfinall yunderstoo d tha t ther e
wer e a lo t o f fue l additive s ou t there , i t wasn' t jus t methano l an

d ethanol . So , I' mno t sur e howEP Acan us e tha t informatio n in thi s rulemaking , bu t I thin k yo u ough t t o b e lookin

g a t th e legislativ e histor yt o se e wha t Congres s ha

d in min

d whe n theywrot e thes e provisions . I thin k i t can be usefu l suppor t fo r focusing your efforts . 10 2P. 5

MS . GILHOOLEY : I gues s par t o f i t i s tha t the

y als o have thi s concer ntha t ther e b e enough testin g befor e yo u mak e decisions , s o that' s par t o f i t

w e have t o loo

k a t too . MR . KELLER : That' s right , but , well , remembe r the statutory languag e i

n21 1 (c ) is , ma

y als o require , an

d s o I think what' s importan t fo r EP A t o d o i s t o justif y

an y decisio ntha t they d o mak e regarding eithe r testin g o r non-testin g i nan y particula r registration . S o i f th e regulation s ar e writte ns o a s t o provid e yo

u enoughdecision-makin g proces s base do na ris k assessment , base d onthi s Tie r 1 o r Tie r 2 matri x informatio nthat' s submitte d b y th e registrant , I thin k tha t canbe used t o suppor t a non-testin g decision . Again , yo

u d o hav e othe r option s to o wit hTSC A powers , s o I think there' s a wa y t o structur e thi s aroundwha t you'v e alread

y described , i f yo u canbegi nt o focu s thi s thin g a littl e bi t more .

MS . GRAHAM : I have a questio nabou t the toxicit y

testing . I t goe s t o th e point s you'r e raising
onth e botto

m o f pag e tw

o an d som e point s yo

u raise d verbally , an

d I gues s I' d like t o as k yo u t o expanda littl e bi t uponthem .

Basicall y

yo u suggeste d o r yo usai d tha t



### 10 3P. 6

j th e toxicit ytestin g whic h woul d probabl yg o beyon d th e limit s o f establishe d methodolog yand technology , an d i f I tr yand subse t tha t into , on e ca n discus s th e availabilit yo f methods , on e ca n als o sa yfo r whateve r method s ar e availabl e ho wdifficul t the yar e and anothe r categor ywoul d b e ho wcostl ythe yare , bu t a t leas t i n

m yreadin g o f thi s paragraph , I sens e a lo t o f i t i s th e metho d itself , a s oppose d t o difficult yo r cost . Woul d yo u lik e t o expan d a littl e bi t mor e o n you r points ?

MR . KELLER : I' mno t sur e tha t cos t i s goin g t o b e bi g issu e fo r th e businesse s involved . I' m
no t sur e ho wbi g a n issu e i t i s i n EPA' s min d i n thi s rulemaking , s o I didn' t focu s o n th e cos t issu e a t all . Wha t I thin k w e d o nee d t o b e ver yconcerne d abou t i s a point , I think , tha t wa s raise d i n th e D u Pon t presenta
tion , wher e i f yo u wer e lookin g a t combustio n emission s
an d lookin g fo r th e effec t o f a particula r fue l additive , whic h ma yb e ther e a t ver ylo wconcentrations , fo r instance , 5 0 part s pe r millio n i n th e liqui d fuel , yo u ar e goin g t o nee d a tes t whic h i s very , ver y sensitiv e t o detec t anydifference s whatsoever .

I n ou r vie wo f curren t testin g methodologies , a lo t o f thi s i s base d upo n th e lubrican t additive s experienc e we'v e ha d i n testin g lubricants , 

### 10 4P. 7

fo r instance , i

nengin e tes t stands . There' s a lot o f variabilit y

i nthe wa

y the engine s operate , fro m stan d t o stand , i

nthe sam

e engin e fro

m wee k t o week . There' s al l kind s o f effect s tha t happe na s the engin e break s in , a s the engin e start s t o wear . A chroni c toxicit y tes t woul d probabl y go beyon

d the usefu l lif e o f a n engin e o

na stand , s o you' d have t o switc hou t engine s during the test , an d yo u woul d se e spike s i nyour emission s becaus e o f that .

So , I think becaus e we woul d expec t tha t you'r e looking fo r very , ver y fin e differences , perhap s
no differenc e a t all , an d becaus e thes e test s hav e no t bee ndevelope d t o loo k fo r thes e difference s an dtha t w

e kno w there' s a lo t o f variabilit y i nstan d testin g o f engine s an

d o f lubricant s inthes e engines , we'r e no t confiden t tha t thes e method s ar e ver y clos e t o being applicabl e fo r biologica l testing . Beyond th e problem
o f jus t running a nengin e consistentl y withi nvery , ver y clos e specification s wit ha s littl e variabilit y a s possible , you'r e no w addin g onthe variabilit y tha t yo

u
se e i nal l toxicology

experiments , an

d tha t compound s the overal l variabilit y o f the entir e study . So , I think wha t you'r e lef t wit hi s a situatio nwher e yo u coul d ver

y easil y

predic t tha t



### 10 5P. 8



### " 1 

## J you'r e no t goin g t o se e difference s betwee n a bas e line fue l an d additiv e combinatio n versu s your teste d mixtures , an

d i t woul d the n be pointles s t o d o tha t kin d
o f testing . So , I thin k w e reall yar e runnin g int o a technologica l wal l here , an d I thin

k EP Aneed s t o conside r tha t an

d look a t tha t issu e prett yhard becaus e it' s goin

g t o driv e wher e thes e regulation s can effectivel ybe . Th e othe r poin t tha t I mad e i s tha t we don' t thin

k tha t anybod

ycoul d agre e toda

yon wha t the prope r bas e lin e combinatio n woul d be in term s o f whos e fue l it' s goin

g t o be , whos e additiv e it' s going t o be , whos e engin e it' s goin g t o be , you know , wha t kin d o f tes t stand , operating unde r wha t loa d condition s fo r the engine . There' s s o man yissue s tha t woul d come up , thi s coul d be a fiv e da

ysymposium , an

d I don' t thin

k w e woul d reac h a resolutio n a t th e en d fo r th e operating condition s fo r thos e tests .

MS . GRAHAM : I sens e i n you answe r there , whic h i s ver yusefu l an

d ver yinformative , I
sens e anothe r commen t tha t migh t be directl ypertinen t t o th e protocols , an d le t me jus t as k i f I interprete d properly . Essentiall yyou'r e envisioning an ypossibl e testing guideline s a s no t bein g on th e individua l

10 6P. 9

L . J 

### chemica l a s i t i s combuste d out , a s i t i s a n emissio n product . So , fo r example , i f a n additiv e i s used , you woul d envisio n th e testing bein g th e additiv e presen t i n th e gasolin e i s combusted , a s oppose d t o the admitte d fractio n combuste d a s a pur e chemical . S o you'r e envisioning thi s al l a s a comple x mixtur e program ?

MR . KELLER : I t woul d hav e t o be , eve n in the bas e line engin e tha t you' d ru n fo r compariso n purpose s a s a contro l group . Yo u coul d no t ru n i t withou t additives , unles s you wer e going t o ru n an engin e tha t wa s specificall yconstructe d wit h a fue l systemt o preven t deposi t formation , an d the n you' d stil l be runnin

g a ris k on deposit s during th e test . So , I woul d anticipat e tha t eve n in th e bas e line contro l grou

p you woul d hav e t o hav e some combinatio n o f additive s an

d some accepte d fuel . I thin k that , yes , i t woul d be almos t pointles s t o tes t individua l additiv e component s in a fuel . Yo u woul d wan t t o tes t th e additive s a s they'r e registere

d in a fuel , i

n combination . A s I state d before , gasolin e need s mor e than jus t deposi t contro l additives . There' s othe r thing s tha t ar e adde d a s well , including dyes . MS . GRAHAM : Right , bu t tha t take s in a
10 7P.1 0

L J 

### comple x mixtur e becaus e lik e i f w e use d the exampl e o f lea d a s bein

g a n additive , on e can measur e lea d comin g
ou t o f a tailpipe , woul d knowwha t it s specie s i s an d d o studie s o n lea

d an d the n mak e some extrapolation s abou t wha t leaded gasolin e migh t do . O f cours e lea d i s a nice , eas yexampl e here . Th e rea l worl d i s quit e mor e complex , s o you wouldn' t propos e testing an yemitte d produc t a s a

n individua l chemical , woul d tha t be correct ? MR . KELLER : I' m no t sur e wha t w e woul d propos e a t thi s point . Thi s i s s o fa r beyon d wher e w e thin k w e can g o wit h th e technolog yrigh t nowtha t I' m
no t sur e I can answer . Tha t migh t no t be righ t o r i t migh t no t be wrong a t thi s point . Wha t I coul d commen t i s I thin

k w e nee d t o pu t lea d behin d u s an d no t le t lea d become th e mode l o f fue l additive s becaus e I , an d I thin k th e res t o f th e industry , I don' t wan t t o spea k fo r everyon e else , thi s i s mor e o f a persona l opinion , bu t I thin

k we'v e allowe d lea d t o become th e mode l fo r fue l additives , an

d it' s reall yno t a n appropriat e compariso n fo r th e vas t majorit yo f additives , including thos e whic h ar e currentl ycovere d b ythe , substantiall y similar , provisions .

MS . GRAHAM : Than

k you . 

### 10 8P.1 1

MR . PASSAVANT : I' d like t o as k tw o questions , i f I could , please . Numbe r one , I' dlike t o
as k you , i f yo

u can' t respon

d now , respon

d fo r the
record t o the comment s tha t wer e mad e b y D u Pon t regarding the Smal l Busines s provisions , CM A represent in g a numbe r o f companies , I' m sure , o f variou s size s
an d variou s interests . W e woul d reall y

appreciat e your inpu t a s t o ho

w your differen t membe r companie s o r you r associatio nmigh t vie w thos e provision s an d ho w the y can bes t be implemented .

M y second questio ni s reall y generi c i

n nature . I' d reall y lik e t o as k you , wha t i nth e ANPRM , the content s pu t ou t i nth e ANPRM , you woul d specifi call y tak e issu e with , i f any ? We reall y wan t t o ge t a

n ide a i f we'r e goin g i nth e righ t directio ninyou r poin t
o f vie w o r i f there' s som e changin g cours e you migh t sugges t we make ? MR . KELLER : T o commen t onthe firs t questio no f smal l business , we wil l commen t i nth e writte nprovisions. We didn' t se e i t a s being a thresh ol d issu e a t thi s point , thoughi t i s a nimportan t issue , an

d I als o recogniz e tha t t o som e exten t you r hand s ar e tied b

y statut e onthi s one . Yo u hav e t o writ e provision s onit , onsmal l businesses . 

### 10 9P.1 2



### ' 1 i . J 

### MR . PASSAVANT : Actuall yi t says , may ; i t doesn' t say , must .

MR . KELLER : Well , you ma yals o requir e testing , an

d you seemt o hav e gon e dow n tha t roa

d pretty fa r too . I n term s o f your overal l directio n an d ho wth e CM

APetroleu

mAdditive s Pane l feel s abou t tha t direction , I thin

k a t thi s poin t ou r concer n i s tha t becaus e you haven' t ha d an ytime , becaus e o f th e stric t timetabl e that' s bee n sen t i n th e consen t orde r whic h you signed , tha t ther e hasn' t bee n enoug h time t o evaluat e th e informatio n that' s ou t there , th e regulator

ybackdrop , th e interactio n o f thi s potentia l regulatio n wit h existing regulation s an d statutes , an

d hence , a t thi s poin t you'r e rathe r unfocused . I thin k that' s ou r bigges t concern , tha t ther e need s t o be mor e focu s in thi s rulemaking .

MR . PASSAVANT : You'r e saying , focus , o r are yo u saying preliminarydecisio n making ?

MR . KELLER : Well , i t ma ybe in fact , i

n th e wa yyo u writ e rules , preliminar ydecisio n making , base d on th e dat a that' s ou t there .

MR . PASSAVANT : Well , you can understan d tha t in a

n ANPR M w e specificall ytr yt o avoi d that . W e

11 0P.1 3



### don' t wan t t o mak e decision s in havoc .

MR . KELLER : Yes , I thin k you'v e go t the issue s on th e table . Ther e ma ybe som

e mor e tha t ge t raised i

n writte n comments , bu t I thin k mos t o f th e issue s ar e nowon the table . I thin k it' s no

wtime t o star t putting some o f thos e t o bed an d t o ge t t o th e importan t issue s whic h w e thin k ar e setting u

p a matri x whic h fit s int o wha t th e rea l environmenta l an d healt h
concern s are . MR . PASSAVANT : D o you suppor t th e concepts , suc h a s grouping s tha t we'v e talke d about ?

MR . KELLER : Yes , wit h substantiall y simila r provision s being a t leas t a starting poin t fo r thos e groupings . MR . PASSAVANT : An d your statemen t generall ysupporte d th e tiere d approac h a s wel l in term s
o f approach , in your writte n comments , i f you have an y thought s on howthos e tier s migh t be optimized , a s i t
seeme d t o us ? MR . KELLER : Yes , I thin k in fac t that' s something w e ha

d intende d t o do , i s t o provid e comment s
on thos e an

d mayb e a suggestio n on ho wthe ymigh t be modified , MR . PASSAVANT : Than k you .
11 1P.1 4

MR . GRAY : Than k yo u ver ymuch . Alas t chance , i f anyon e i n th e audienc e woul d lik e t o mak e a statemen t o f an ytype , almos t an y type , no wi s you r las t chance .

W e than k yo u al l fo r comin g and w e d o loo k forwar d t o follow-u p participation , and a s w e sai d

a t th e beginning , w e reall ywan t t o sincerel ysolici t

som e hel p i n puttin g thes e togethe r s o tha t the yar e effective , bu t realisti c a s well . Than k yo u agai n fo r coming . (Proceeding s conclude d a t 12:1 5 p.m. )



### 11 2P.1 5



### STAT E O F MICHIGA

N) COUNTY O F WASHTENAW )

I , Susan Beale , Cour t Reporter , hereb yd o certif ytha t thi s transcript , consisting o f 11 2 pages , i s a complete , tru e an d correc t record o f the Publi c Hearing o f th e Environmenta l Protectio n Agency , in th e matte r o f Fuel s an d Fue l Additive s Registration , Advanc e Notic e o f Propose d Rulemaking , EP AAi r Docke t [LE-131] , Docke t #A-90-07 , hel d a t Domino' s Farms , An n Arbor , Michigan , on Wednesday , Septembe r 26 , 1990 .

<^^^r^ 

# /CisieA <7 

### Susan Beale , CSM

R 274 1 Wester n Wayn e Cour t Reporting Plymouth , Michiga n (313 ) 453-723 2

Octobe r 10 , 199 0 112 a