# OAR Box 1834 Prepped by Keeia Richards



### Document

Number: 

# 35 ) IV-E-0

8 Docket Number: 

# A-90-07

Printed 11/10/20082:14:35PM Sheet 35of 61 P. 1P. 2

\ UNITE D STATE S ENVIRONMENTA L PROTECTIO N AGENC Y 

# I 3.^yt f r
OFFIC E O F AI R AN D RADIATIO N 

### JA N 

### 2 8 199

4

MEMORANDU M SUBJEICT : Meetin g Betwee n EPA , API , an d CM ARegardin g

Fuel s an d Fue l Additive s (F/FAs ) Registratio n Regulation s >M : ine s de l C . Figueroa , Environmenta l Scientis ?

Specia l Regulator yProject s Branc h 

## 'Jt/f^jtf**^

THR U : Judit h Gray , Senio r Projec t Manage r CAudw^SsX*****^

Specia l Regulator yProject s Branc h [\ Docke t No . A-90-0 7 O n Tuesday , Januar y25 , 1994 , EP Amanagemen t an d staf f me t h representative s fro mth e America n Petroleu mInstitut e (API ) tn d th e Chemica l Manufacturer s Associatio n (CMA) , a t thei r request , t o discus s th e directio n o f th e F/F Afina l rule . Th e meetin g too k plac e a t EPA' s Nationa l Vehicl e an d Fue l Emission s Laborator yi n An n Arbor , Michigan . Alis t o f th e attendee s i s attached . Als o attache d i s a lette r fro mAP I statin g thei r inten t t o mee t an d listin g thei r mai n concerns . Topic s discusse d durin g th e meetin g include d groupin g provisions , complianc e an d timin g requirements , relationship s wit h othe r EP Arulemaking s (e.g. , detergents , reformulate d gasoline) , p e an d testin g requirement s fo r th e differen t tiers , adequac y o f existin g data , implementatio n issues , registratio n requirement s ne w F/FAs, alternativ e testin g i n lie u o f Tie r 2 , an d emissio n generatio n methodology . EP Aals o discusse d th e possibilit yo f 1 i shin g a Notic e o f Reopenin g o f Commen t Perio d t o clarif ysom e complianc e issue s an d t o discus s som e technica l modification s develope d sinc e th e propose d rul e wa s published . Attachment s



## JA N I {99 4P. 3 

# A-10-0 7

EP AAPI/CM

AMEETIN

G ONF/F

A 2 5 Januar

y199 4
NAM E Glen n Passavan t Jud yGra y Che t Franc e Ine s Figuero a Ken t Helme r Charli e Kelle r Davi d Mongill o Bo b Wilkenfel d Jo e Marcine r Anit a Ducc a Phili p Bus h ORGANIZATIO N EP A EP A EP A EP A EP A Exxo n Chemica l AP I Chevro n Mobil e AP I Amoc o Oi lP. 4 

# jE-e-o g American Petroleu m Institut e 122 0 L Street , Northwes

t Washington , D.C
. 2000

5 202-682-800

0 

# 4 >

Januar y19 , 1994 Ms
. Judit h Gra

y Senio rProjec

t Manage r Specia l Regulator

yProjects Branc h Unite d State s Environmenta l Protectio n Agenc y 256 5 Plymout h Road
. Mai l Cod e RDSD-1 2 An n Arbor , M l 4810 5 Dea r AP I appreciate s th e opportunit yt o meet wit h yo u an d th e rest o f th e EP Astaf f preparin g th e fina l rul e implementin g sectio n 211(b ) Fuel s an d Fue l Additive s (F/FA ) o f th e Clea n Ai rAct
. W

e wil l b e a

t you roffice s a

t 10:0 0 o n Tuesday , Januar y25
. Alis t o

f AP I membe rcompan yrepresentative s an d staf f wh o pla n t o atten d th e meetin g i s attached
. API' s primar

yconcer n regardin g thi s rulemakin g i s its interrelationshi p wit h th e recentl y promulgate d rul e o n reformulate d gasolin e (RFG)
. Ou rabilit yt o meet th e energ yneed s o f th e natio n wit h reformulate d gasolin e i s dependen t o n providin g th e dat a that coul d b e require d unde rth e F/F

Arule
. Thus , ou rprimar yobjective i n thi s meetin g i s t o obtai n a clea r understandin g o

f th e directio n o

f th e Agency' s plan s fo rtestin g requirements i n th e fina l rul e an d ho wth e tim e frame s fo rmeetin g thos e requirements wil l coincid e wit h th e RFG rule' s requirements
. I n addition , th e requirements fo rprovidin g tes t dat a specifie d i n th e recentl ypropose d rulemakin g o n detergen t additive s wil l hav e a n impac

t o n bot h th e F/F

Arul e an d th e RF G requirements
. Thus , a bette runderstandin g o f th e interconnectio n betwee n th e F/F Arule' s requirement s an d thos e o f th e detergen t additive s rul e i s als o critica l t o th e implementatio n o f al l thre e regulations
. Give n thes e objectives , w e suggest that thi s meetin g focu s o n th e followin g points : Groupin g o

f Fuels : Ho

wwil l RFG b e categorize d i n an ygroupin g syste m fo rtestin g purposes ? If EP

Adecide s against a singl e grou p o f fuel s fo rtestin g purposes , wha t wil l b e th e construc

t o f th e groups , e.g. , bytyp e o f oxygenat e o radditive ? Thi s issu e i s o f critica l interest becaus e o f th e languag e containe d i n th e fina l RFG rul e statin g that "th e F/F

Afina l rul e i s expecte d t o conside reac h gasoline/oxygenat e blen d a s differen t formulation
. Thus , fue l producer s woul d b e responsibl e fo rth e testin g o f eac h gasoline/oxygenat e blen d covere d b yth e respective fue l registration. "
A n equa l opportunit yemploye rP. 5

Januar y19 , 1994 Pag e 2 Timin g wit h RFG : Wha t ar e EPA' s plan s fo rensurin g that testin g requirement s wil l no t conflic t wit h th e RFG rule' s requirements t o manufactur e an d sel l reformulate d gasolin e afte rth e thre e yea rmandate d testin g tim e period ? Thi s questio n relate s to th e fina l RFG rul e whic h state s that "Furthermore , oxygenate d compound s that are liste d bu t not teste d withi n th e allotte d tim e perio d (i.e
. thre e years ) coul d not b e use d b yth e manufacturer. " Scope : Wha

t i s EPA' s positio n o n adoptin g API' s recommendatio n t o limi t requirement s fo rtestin g t o th e healt h effect s o f tailpip e emissions ? Timin g wit h Detergen t Additives : Ho wwil l EP Aensur e that th e testin g requirements , an d th e timin g o

f submittin g tes t result s require d unde rth e detergen t additive s rulemaking , wil l not conflic t wit h th e requirements o f eithe rth e F/F

Arul e o rth e RFG rule ? Fue l Designatio n Rule : Wha t ar e EPA' s plan s fo rproposin g th e fue l designatio n rule , an d wha t alternative fuel s wil l b e designate d fo rtesting ? Speciation : What , i f any , emission s speciatio n requirements ma yb e include d i n th e fina l rule ? W e hav e als o attache d a lis t o

f detaile d question s whic h reflec t som e o f th e point s that ma ynee d t o b e discusse d whil e coverin g ou rmai n concerns . W e hop e t o b e abl e t o addres s the m durin g th e meeting
. I loo k forwar d to seein g yo u o n th e 25th
. I n th e meantime , i f there ar e an yothe r issue s yo u wis h t o discuss , pleas e d o no t hesitat e t o cal l m e a

t 202-682-8326
. Sincerely , Anit a T
. Ducc

a Coordinator , Healt h an d Produc t Stewardshi p Attachments
cc : Cheste rJ
. Franc

e Gle n Passavan t G
. Willia m Fric k

Richar

d D
. Wilso n Charle s L
. Gra

yP. 6

Attachmen t 1 ATTENDEE S

1
. Phi l Bush , AMOC O 2
. Alic e Crowe , AP I 3
. Anit a Ducca , AP I 4
. Charle s Keller , Exxo n Chemica l 5
. Jo e Marcinek , Mobi l 6
. Davi d Mongillo , AP I 7
. Rober

t Wilkenfeld , Chevro nP. 7

i I
Attachmen t 2

QUESTION S RE : PROPOSE D SEC . 211(b) REGULATION S Groupin g Issue s

* Th e fina l RF

G regulatio n state s that : "I n fact , th e F/F

Afina l rul e i s expecte d t o conside reac h gasoline/oxygenat e blen d as a differen t formulation
. Thus , fue l producer

s woul d b e responsibl e fo rth e testin g o f eac h gasoline/oxygenat e blen d covere d b yth e respective fue l registration
. Furthermore , oxygenate d compound s that ar e liste d bu t no

t teste d withi n th e allotte d tim e perio d (i.e
. thre e years ) coul d no

t b e use d b

yth e manufacturer. " Ho wwil l EP Astructure th e testin g an d dat a requirements o f th e F/F Arul e t o ensur e thei rcompletio n withi n th e thre e year s specifie d i n th e statut e s o that there ar e n o conflict s wit h th e requirements fo rmanufacturin g an d marketin g reformulate d gasoline ?

* Wil l EP

Aallowgroupin g o

f fuel s fo rtestin g purposes ? Wil l RFG remai n i n a larg e baselin e grou p wit h unleade d gasoline ? I f groupin g i s allowed , wil l EP Aadopt API' s recommende d boundarie s o f al l "substantiall ysimilar " an d "waivered " gasolin e i n orde rt o avoi d th e potentia l confusio n that coul d resul t b yestablishin g differen t regulator ydefinition s fo r certificatio n an d fo rtesting ?

* Wil l manufacturer s o f "new " fuel s o radditive s whic h fal l withi n th e definitio n o f th e baselin e categor

yb e automaticall yinclude d i n tha t grou p an d assum e th e statu s o f "existing " fue l an d additives ? I n th e Decembe r6 , 1993 , gasolin e detergent s rule , EP Apropose d that al l detergen t additive s b e full yteste d b yJanuar y1 , 1996
. Thi s include s "th e ful l set o f requirements , includin g locatin g tes t fuel s an d conductin g vehicl e testing. " Thus , thi s requiremen t wil l com e befor e an yrequire d testin g unde rsectio n 211(b)
. Ho wwil l EP Aensure consistenc

yo f th e testin g requirement s fo rthes e tw o rule s particularl ywit h respec t t o th e selectio n o

f th e tes t fuels ? Wil l conventiona l fue l familie s be limite d t o diese l fue l an d unleade d gasoline ?P. 8

Wha t i s th e statu s o

f th e diese l fue l "substantiall ysimilar " rule ? Wil l th e definitio n fo ratypica l diese l reference elements othe rtha n "carbon , hydrogen , oxygen , nitroge n an d sulfur" ? Fo rgroupin g o

f simila ratypica l fuels , wil l EP Aallow consortium s t o presen t thei rrational e fo rclaimin g that selecte d fuel s b e groupe d fo rpurpose s o f registration ? I s th e presence o rabsence o f polymer s goin g t o b e use d as a groupin g criteri a fo ratypica l categorie s o

f diese l an d gasoline ? I f so , has EP Aconsidere d establishin g a d e minimi s leve l t o allowsmal l amounts t o b e include d i n th e bas e category ? Whe n wil l th e fue l designatio n rul e b e proposed ? Wha t alternativ e fuel s wil l b e designate d fo rtesting ? Timin g Issue s Since th e 1 8 mont h tim e fram e allocate d fo rEP Aevaluatio n o

f Tie r1 informatio n wil l substantiall yimpac t th e amoun t o

f testin g that coul d b e complete d withi n th e remainde ro f th e thre e year

s allowed , ha

s EP Aconsidere d reducin g eithe rth e amoun t o f testin g require d o rth e amoun t o f tim e fo rit s ow n evaluation ? Ho wwil l th e propose d tim e frame s fo rcompletin g th e tes t requirement s i n th e detergen t additive s rul e effec t th e timin g o

f testin g require d i n th e fina l 211(b ) rule ? Give n th e complexit

yo f th e scientifi cissue s that wil l requir e evaluatio n i n respondin g t o a Tie r3 testin g requirement , has EP Areconsidere d th e 30-da y tim e perio d i n whic h manufacturer s mus t respon d t o notificatio n o f a Tie r3 testin g requirement ? Since man yfuel s coul d remai n o n th e market fo rextensive period s o f tim e afte r testin g i s completed , wil l EP Aconside rextendin g th e reimbursemen t procedure s fro m 5 year

s t o 1 5 year

s as suggeste d b

yAPI ?P. 9

\ < . J Healt h Effects Issue s

* Ha s EP Adetermine d whethe rth e lac k o f scientificall yvalidate d tes t protocol s fo rvehicl e emission s testin g o f laborator

yanimal s wil l presen t a proble m fo r meetin g th e statutor

ytimin g requirements ? I n ligh t o f th e feasibilityan d laborator ycapacit yissue s identifie d b

yAP I i n ou r comments o n th e propose d rule , has EP Areconsidere d th e requirements fo r includin g reproductive , pulmonar yan d neurologi ceffect s i n Tie r2 o f th e propose d rule ? Wha t has EP Adecide d regardin g API' s suggeste d optimizatio n schem e t o require anima l testin g onl yi n Tie r3 , an d require i n vitro test s i n Tie r2 ?

* Doe s EP

Astil l pla n t o mandate searche s o f aj [ possibl e toxicologica l effect s associate d wit h emissions ? Ho w wil l EP Adefin e th e searc h requirements ?

* Ho wwil l EP Areconcil e thei rpropose d requiremen t fo rGoo d Laborator y Practice s (GLP's ) whe n emission s ar e no t define d tes t substance s an d wil l likel yvar ydurin g tes t procedures ?

* Wil l EP

Adelet e fro m th e fina l rul e additiona l evaluation s suc h as th e acut e healt h assessmen t an d th e inhalatio n reference concentration ?

* Wil l realisti cexposur e estimate s an d dose-respons e extrapolation s b e use d rathe rtha n "worst case " assumption s t o determin e whethe rtestin g i s necessar y above an d beyon d wha

t i s alread yavailable ?

* Wil l EP

Afacto ri n th e valu e an d applicatio n o f th e "requisit e information " usin g fixe d protocol s as oppose d t o mandatin g testin g o n a prescribe d set o f endpoints ? Emission s Speciatio n Issue s Wil l th e extensive Auto/Oi l dat a satisf yEPA' s requirements fo rresearc h an d speciatio n o n emissions ? O rwil l EP Arequire additiona l emission s data ?

* Doe s EP

Apla n t o limi t testin g t o vehicl e exhaust emissions ?

* Ha s EP Aconsidere d API' s suggestio n that EP Amaintai n a librar

yo f informatio n o n th e effect s o

f emission s an d th e constituent s o f emission s rathe rtha n require eac h manufacture rt o conduc t hi s ow n search ?P.1 0

Welfare an d Environmenta l Effects Issue s

* Wil l th e fina l rul e stil l require a literature searc h fo rwelfare effects , whic h AP I believe s goe s beyon d EPA' s goa l o f collectin g onl yinformatio n neede d fo r regulator ypurposes ?

* Wil l modellin g an d evaluatio n o f welfare effects , expecte d atmospheri c transformatio n products an d th e predicte d environmenta l partitionin g o f emission s int o air , soil , wate ran d biot a b e require d as par t o f th e Tie r1 submission ? I f yes , wil l EP Aoffe rguidance as t o ho w thi s wil l b e accomplished ? Cos t Issue s

* Ha s EP Areevaluate d th e estimate d cost s o f testing ? Ho whas EP

Adecide d t o dea l wit h th e cos t reimbursemen t procedures ? Miscellaneou s

* Wha

t ar e th e over-archin g concern s an d goal s that th e Agenc yintend s t o addres s wit h thi s rule ? Ho w doe s th e Agenc

ydefin e th e valu e adde d t o th e regulator ydecisio n activitie s underwa yo rplanne d fo rth e nea rfuture that wil l b e aide d b

ycollectin g th e dat a define d b ythi s rule ?

* Wil l missin g endpoin t dat a automaticall ytrigge rTie r2 testin g eve n i f suc h testin g ma

yno t b e necessar

yfo rregulator

ydecisio n making ?

* I n ligh t o

f th e continuou s advance s bein g mad e i n researc h methodologies , has EP Aconsidere d API' s suggestio n t o specif yTie r3 protocol s an d detail s separatel yfro m thi s particula rrul e i n orde rt o allow bot h th e Agenc yan d th e industr yt o take advantag e o

f scientifi cimprovements that ma yoccu rafte rit s promulgation ? Wil l EP Apermi t th e us e o

f existin g data , i n lie u o

f modelling , o n ambien t levels ?

* Wil l th e fina l rul e establis h a mechanis m fo rprotoco l review ?P.1 1

- Give n th e technica l difficultie s wit h collectin g emission s fro m car s fo rpurpose s o f exposin g animal s unde rlaborator yconditions , wil l th e fina l rul e require us e o f mor e tha n on e ca rfo rth e anima l testing ? Wil l th e fina l rul e includ e th e elaborat e tes t fue l samplin g an d mixin g requirements describe d i n th e proposal ? O rwil l there b e a simplifie d versio n determine d alon g wit h th e othe rresearc h decision s that nee d t o b e mad e a t th e tim e o f developin g th e tes t protocol s a s strongl yrecommende d i n th e AP I comments o n th e NPRM ?