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# OAR Box 1846 Prepped byOllie Stewart



### Document

Number: 

# 50 ) ll-F- 4 Docket Number: 

# A-90-07

Printed 11/18/20087:30:16

AM Sheet 50of 93

### T •v MA

R J 8 1992-A H •f~04 P. 2

NOT E
TO : TroyHillier , OMB Ric hTheroux , OMB
RE : Transmitta l o f Change d NPRMPage s fo r th e Fuels/Additive s Program Th e NPRMchange s w e discusse d a t ou r Marc h12t hmeetin g ar e reflecte d i nth e attache d pages . T o facilitat e you r review , th e change d materia l i s indicate d b yarrow s i nth e lef t margin . Also , wher e a pag e numbe r ha s change d i nrelatio nt o th e previou s draf t (dated 12/10/91) , th e corresponding pag e numbe r i nth e earlie r draf t i s show

ni nbracket s i nth e lowe r righ t corne r o f th e ne w page . Mos t o f th e ne wmateria l relate d t o th e interpretatio no f negativ e tes t result s and t o criteri a whic hwoul d indicat e tha t Tie r 3 wil l no t b e necessarycanb e foun d o n(new ) page s 191-200 . Pleas e giv e m e a cal l (374-8231 ) i f an yquestion s arise . A s yo u know , ou r time i s extremel yshor t an d I loo k forward t o receiving you r comment s and/o r concurrenc e b ytomorrow . Thank you ,P. 3

thi s mayb e appropriat e fo r defining baselin e formulation s i n thi s propose d program . However , EP Ai s als o considering restricting baselin e formulation s t o thos e wit hles s tha n 1. 5 weigh t percen t o f oxygen . I nth e latte r case , "reformulated " fuel s woul d b e exclude d fro mth e "baseline " classification . Thi s woul d resul t i nth e generatio no f mor e explici t informatio n fo r variou s oxygenate d gasolin e fuels . 

### 4. HealthEffectsTesting Provisions Anumbe r o f respondent s argue d tha t anoverl ystringen t an d expensiv e healt heffect s testing programwoul d b e counte r t o th e publi c interest . Theypointe d ou t tha t unreasonabl y highcost s o f programcomplianc e woul d discourag e th e developmen t o f ne wfuel s an d additive s an

d woul d reduc e th e availabilit yo f product s potentiall ybeneficia l t o th e publi c

- » healt hand welfare . Whil e th e testing programmus t provid e

— » adequat e informatio nfo r assessing th e toxicit yo f fuel s an d

— » additives , EP Ai s wel l awar e o f th e importanc e o f striking an

- » appropriat e balanc e betwee nscientifi c demand s an d technica l

— > an d financia l constraints , taking int o accoun t bot hth e nee d

— » fo r adequat e informatio nan d th e nee d fo r continue d

— > innovation . Th e Agenc ybelieve s tha t th e programoutline d i n th e propose d rulemaking i s consisten t wit hth e statut e an d reflect s a reasonabl e an d cost-consciou s approac ht o a very comple xregulatoryarea .

2 3P. 4

EP Adoe s no t agree , however , tha t th e manufacture r o f an additiv e shoul d b e relieve d o f registratio nresponsibilitie s jus t becaus e o f th e additive' s similarit yt o it s paren t fuel . Instead , provision s withi nth e propose d grouping systemshoul d b e abl e t o accoun t fo r thes e relationships . Suc hmechanism s ar e discusse d furthe r i nSectio nIV , below . 

### 5. Small

BusinessProvisions Unde r sectio n 211(e) , EP Ai s authorize d t o creat e specia l program allowance s and/o r exemption s whic hwoul d reduc e th e burden s o f program complianc e fo r smal l businesses . I f EPA shoul d choos e t o exercis e thi s authority , th e operativ e definitio no f a smal l busines s woul d b e specifie d withi nth e associate d regulations . Respondent s wh o commente d o n thi s matte r fel t tha t an ysmal l busines s definitio nwoul d b e arbitraryand unfair . I nthei r view , smal l busines s provision s coul d potentiall yplac e individua l manufacturer s wh o sol d multipl e low-volume product s a t a disadvantag e relativ e t o single-produc t manufacturers . Theyals o believe d tha t th e rule s governing smal l busines s allowance s coul d b e manipulate d b

ylarg e manufacturers , creating loophole s neve r intende d b

yEPA .

— > Whil e EPAdoe s no t necessaril yshar e eac ho f th e

— > respondents ' concerns , thi s NPRMdoe s no t contai nspecifi c

— » propose d provision s fo r smal l businesses . I ngeneral , th e

— > propose d grouping scheme , tiere d testing structure , an d othe r 2 7P. 5

—»genera l provision s shoul d assur e tha t undu e burden s ar e no t —»place d upo n smal l businesses . Nevertheless , EPA' s analysi s

— > indicate s tha t th e cost s o f complianc e wit hth e propose d

- » program

mayplac e a fewsmal l businesse s i nfinancia l

— > jeopardy . EP Ai s thu s attempting t o identif yth e

— » characteristic s whic hmaymak e some smal l companie s unusuall y

— » vulnerabl e t o th e potentia l financia l impac t o f th e propose d

— > requirements , an

d t o specif yfai r an d appropriat e approache s

— > fo r providing cos t relie f t o suc hcompanies . Thes e topic s ar e

— » discusse d furthe r i nSectio nVIII.C . E . Ke yTerm s
Afue l i s define d t o b e an ymateria l whic hi s capabl e o f releasing energ

yo r powe r b

ycombustio no r othe r chemica l o r physica l reaction . Onl yfuel s intende d fo r us e i nmoto r vehicle s ar e include d unde r th e propose d regulations . Currently , fuel s intende d fo r us e exclusivel yi noff-road vehicle s ar e no t designate d fo r registration . Bot hdomesti c an d foreignproduct s ar e include d i n th e designation . Afue l additiv e i s an ysubstanc e tha t i s intentionall y adde d t o a fue l an

d tha t i s no t intentionall yremove d prio r t o sal e o r use . Bul k additive s ar e product s whic har e adde d t o fue l befor e th e fue l i s commerciall yavailabl e fo r introductio nint o th e fue l tank o f a moto r vehicle , whethe r adde d a t th e refinerya s par t o f th e origina l blending strea m 2 8 

# c-aP. 6

al l suc hproduct s t o underg o emissio ncontro l systemtesting year s afte r thei r initia l registratio nan d commercia l distribution . Suc hevidenc e o f advers e emissio ncontro l effect s may come t o ligh t a s a resul t o f emissio ncharacterizatio n requirement s include d withi nth e healt heffect s testing provision s o f today' s propose d rulemaking . Th e propose d emissio ncharacterizatio nrequirement s includ e Federa l testing procedure s t o determin e th e level s o f regulate d emission s generate d b

yth e fuel/additiv e o f interest . Shoul d an yo f th e regulate d emissio n product s excee d establishe d certificatio n standards , a nee d fo r examinatio no f th e product' s effect s on emissio ncontro l mayb e indicated .
EP Aals o propose s t o se t up a mechanis mwhic hwoul d permi t vehicl e manufacturer s o r othe r outsid e partie s t o submi t petition s t o EPA , citing evidenc e tha t certai nbrands ,

— > formulations , o r specifi c component s o f fuel s o r additive s ar e

— > harmfu l t o vehicula r emissio ncontrol . I f EP Ajudge s tha t —¥ emissio ncontro l system testing i s warrante d afte r reviewing th e petitio narguments , emissio ncharacterizatio nresults , and/o r othe r availabl e information , th e authorit yprovide d b y sectio n 211(b ) wil l b e exercise d t o bring specifie d fuel s an d additive s int o th e waive r applicatio n programwhe n theywoul d otherwis e b e excuse d b yth e "grandfathering " provision s o f sectio n211(f) . 4 6P. 7

EP Arequest s comment s onth e adequacyo f thi s propose d approach . A s analternative , th e authorit yo f sectio n211(b ) coul d b e exercise d t o requir e al l "grandfathered " product s t o underg o waive r reques t procedure s unde r Sectio n211(f ) i f they d o no t conformt o applicabl e "su bsim " criteria . Comment s ar e

- > solicite d i nregar d t o th e specifi c necessit yan d th e likel y —> cost s an

d benefit s o f thi s mor e comprehensiv e approac hi n compariso nt o th e mechanis mdescribe d above . E . Scope o f HealthEffect s Evaluatio n 1. Background Registratio nrequirement s concerning th e healt heffect s o f fuel s an

d fue l additive s coul d potentiall yencompas s a vas t rang e o f endpoints , exposur e scenarios , mechanism s o f action ,

— > and experimenta l protocols . Taking int o accoun t th e numbe r o f

- » fuel s and additive s i nquestion , a comprehensiv e toxicologi c

— > program

coul d easil yoverwhel mth e capacit yo f existing

— > laboratoryfacilitie s an d suppor t systems , an d th e tota l cost s

— > o f suc ha program woul d b e verylikel yt o excee d it s expecte d

- > benefits . Ove r 6,00 0 fuel s an d additive s ar e currentl y registered , an

d thi s populatio ni s expecte d t o underg o furthe r growt hi nth e nea r futur e a s reformulate d an d alternativ e fuel s an

d thei r additive s gai na wide r rol e i n th e marketplace .

4 7 

# N^lP. 8

studie s o nth e individua l emissio nproduct s o f th e fue l o r additiv e woul d no t adequatel ysubstitut e fo r whol e emissions , unles s emissio ncharacterizatio nstudie s showe d tha t an additiv e ha s onl yon e emissio nproduc t tha t differentiate s it s emission s fro

mth e bas e fuel . Documentatio nwoul d nee d t o b e sufficien t t o determin e tha t th e studie s wer e conducte d i na manne r consisten t wit hgenerall yaccepte d scientifi c principles , goo d laboratorypractices , an d th e specifi c testin g guidelin e i nquestion . Importan t parameter s woul d includ e th e typ e an d numbe r o f tes t subjects , th e numbe r an d adequac yo f dosages , th e methodologyan d duratio no f inhalatio nexposure , an d th e technica l method s use d fo r monitorin g th e progres s o f th e tes t an d fo r analyzing th e results . I ngeneral , th e exposur e duratio nwoul d nee d t o b e a t leas t a s long a s tha t stipulate d i nth e specifie d Tie r 2 guideline ; however , shorte r exposure s woul d b e acceptabl e i f th e tes t result s wer e positive , including a demonstrabl e dose
-

- » respons e relationship . Finally , th e ag e o f th e dat a woul d b e

— > a consideration . I nvie wo f technologica l advance s an d

— » changing technica l standards , olde r studie s woul d b e les s

— » likel yt o b e acceptabl e tha nmor e recen t studies . Nevertheless , th e qualit yo f th e stud ywoul d b e th e deciding factor , no t th e ag e pe r se . Thes e same consideration s woul d late r b e use d b

yEP Ai njudging whethe r th e submitte d test s wer e i ncomplianc e wit hth e programrequirements .

5 7P. 9

Tie r 2 test s ar e negativ e (i.e. , apparentl ynon-toxic) , i f EPA judge d tha t inadequat e laboratoryprocedure s o r technique s interfere d wit hth e tes t results . Whil e th e specifi c objective s an d scop e o f Tie r 3 testing woul d varydepending o nth e concern s identifie d i n th e earlie r tiers , chroni c (2- 3 year ) inhalatio nstudie s woul d sometime s b e included . Chemica l dispositio nstudies , exposur e studies , an d dosimetryanalyse s a s wel l a s additiona l emissio n characterizatio nrequirement s migh t als o b e imposed . Thes e requirement s woul d mos t ofte nb e intende d a s follow-u p t o studie s include d i nTie r 2 . However , EPAreserve s th e genera l authorit yt o requir e th e evaluatio no f othe r endpoint s i f availabl e informatio nindicate s tha t thi s i s necessaryfo r regulatorydecision-making . Fo r example , i f th e literatur e searc hsuggest s tha t th e emission s o f a fue l o r additiv e ar e toxi c t o th e live r o r kidneys , the nEP Awoul d no t b e preclude d fromimposing hepatotoxicit yo r renotoxicit ytesting requirement s unde r Tie r 3 simpl ybecaus e screening studie s fo r thes e endpoint s wer e no t include d unde r Tie r 2 .

— » Sectio n V I o f thi s NPRMpresent s furthe r discussio non

— > th e circumstance s whic hwoul d lead EP At o conclud e tha t Tier s

— > 1 and 2 provid e sufficien t informatio nwithou t invoking Tie r

— > 3 , th e potentia l criteri a fo r imposing Tie r 3 testing

— » requirements , an

d th e likel ynatur e o f suc hrequirements .

6 1P.1 0 

# 3 issue s withi nth e contex t o f th e registratio nprogram . On e alternativ e i s t o retai nth e optio no f imposing welfar e effect s testing requirement s a t th e Tie r 3 leve l whe nth e outcome o f Tie r 1 demonstrate s bot hsignifican t environmenta l M—»toxicit yan

d exposur e potential . Th e criteri a fo r suc h Q

_— » decision s woul d b e simila r t o thos e use d fo r making health


# 5

- » relate d Tie r 3 decisions . Thus , Tie r 3 testing fo r welfar e
^ effect s migh t b e require d i f th e environmenta l partitioning > an

d exposur e analysi s reveal s th e potentia l fo r broa d exposur e / * a t concentration s tha t ar e likel yt o pos e a threa t t o sensitiv e plant s an d animals . I f thi s alternativ e wer e adopted , Tie r 3 welfar e effect s testing woul d b e determine d b yEP Ao na case-by-cas e basis . Numerou s protocol s ar e available . Endpoint s o f concer nfo r aquatic , mammalian , an d avia ntoxicologymigh t include , bu t ar e no t necessaril ylimite d to , letha l concentrations , effect s o ngrowt han

d reproduction , an d bioaccumulation . Plan t toxicologica l endpoint s migh t includ e growth , yield , reproduction , frui t quality , an d tissu e damag e o r loss . The exposur e treatment s fo r suc htest s woul d b e administere d a t expecte d environmenta l concentrations . Specifi c Tie r 3 tes t requirement s woul d b e tailore d t o evaluat e th e potentia l environmenta l problem s identifie d i n Tie r 1 . Fo r example , i f th e Tie r 1 modeling result s indicate d tha t toxi c emission s partitione d t o ai r o r soi l an d pose d a 6 8P.1 1

A s note d above , a fue l famil yha s bee ndefine d fo r leade d gasolin e and associate d additives . However , provision s i nth e 199 0 Amendment s t o th e Clea nAi r Ac t prohibi t th e manufactur e o r sal e o f ne wleaded-fuele d moto r vehicl e engine s beginning wit hmode l yea r 1993 , an d ba nth e sal e o f leade d fuel s fo r on roa d us e a s o f January1 , 1996 . Thus , leade d fuel s an d additive s wil l b e phase d ou t a t abou t th e same time tha t dat a woul d b e submitte d unde r today' s propose d rule . I n vie wo f th e upcoming constraint s o nleade d product s and th e timing o f th e ne wregistratio nprogram' s implementation , commen t i s requeste d abou t th e nee d t o includ e thes e product s i nth e grouping systemor , indeed , i nth e ne wregistratio nprogram itself . Consisten t wit hth e previou s discussio no nfuel-additiv e relationships , eac hfue l famil yinclude s no t onl yth e fuel s reference d i n th e name o f th e family , bu t als o bul k an d aftermarke t additive s whic har e intende d fo r us e i n suc h fuels . Additive s whic hcanb e use d i nconjunctio n wit hmor e tha non e typ e o f fue l ar e propose d t o b e assigne d t o th e relevan t fue l famil yo f whic hth e mos t gallon s o f fue l ar e sol d relativ e t o th e othe r applicabl e fue l families . An alternativ e approac hwoul d requir e suc hadditive s t o b e teste d

— » i nassociatio nwit hal l relevan t fue l families . Commen t i s —¥ requeste d o nthi s alternative , including th e expecte d cost s —>an d benefit s relativ e t o th e propose d approach .
8 0P.1 2

Iner t gases , principall yC0 2 and N 2 , coul d compris e up t o 5 mol e percen t o f th e fue l an d "othe r hydrocarbons " coul d mak e u p a furthe r 3. 5 mol e percent .

• ^ Liquifie d petroleu mga s (LPG) , o r propan e gas , woul d b e j \ require d t o contain , a t a minimum , 8 0 percen t propan e b y 

## c 

# i volume . CARB propose s tha t i t als o contai na maximu mo f 1 0 volume percen t propene , whil e AST Msupport s a maximu mo f 5 volum e percent . Th e limi t fo r butan e an d othe r hydrocarbon s i s propose d t o b e 2. 5 volume percen t an d th e sulfu r conten t i s

— » restricte d t o 12 3 ppmw . Comment s an

d suggestion s ar e requeste d regarding th e mos t appropriat e criteri a fo r distinguishing th e baseline , non baseline , an

d atypica l categorie s withi nth e alternativ e fue l families . A s EP Aacquire s additiona l dat a o nalternativ e fue l an d additiv e formulations , thi s informatio nwil l b e place d i n th e docke t and mad e availabl e fo r publi c inspection . Groups . Th e fuel/additiv e group s ar e subdivision s o f th e fuel/additiv e categories , an d represen t th e fina l leve l o f produc t classificatio nwithi nth e grouping system . Thes e group s ar e th e actua l operating unit s o f th e grouping system . Withi neac hgroup , on e o r mor e formulation s wil l b e chose nt o represen t al l o f th e membe r product s i ncomplianc e wit hth e registratio nprogram' s testing requirements . Relate d cost s wil l b e share d b

yparticipating blender s an d manufacturers . 9 3P.1 3

unleade d gasolin e group s an d 4 7 "atypical " diese l groups . Comment s ar e requeste d concerning thi s propose d grouping

— » scheme an

d possibl e alternativ e approaches . Fo r example , —> commen t i s requeste d onth e necessit yo f establishing separat e

— » group s fo r eac huniqu e combinatio n o f "atypical " element s an d

— > conditions , a s i s proposed . Alternatively , i t migh t b e

— > possibl e t o defin e some reasonabl e rule s o f precedenc e whic h

— » woul d allo wproduct s containing certai n combination s o f

- » "atypical " characteristic s t o b e groupe d wit hproduct s

— > containing onl yon e o f thes e characteristics . Suc han

— » approac hwoul d decreas e th e tota l numbe r o f grouping s an d

— » woul d increas e th e numbe r o f potentia l product s i neac hgroup . Suggestion s ar e als o welcome i nregard t o additiona l variable s (e.g. , aromati c conten t o r th e presenc e o f specifi c oxygenat e compounds ) whic hshoul d b e take nint o accoun t i ndefining group s o f atypica l products , recognizing tha t eac hne wfacto r coul d increas e th e numbe r an d decreas e th e siz e o f th e resulting groups . Fo r eac hgroup , th e representativ e t o b e use d i n satisfying th e group' s testing requirement s i s propose d t o b e th e membe r produc t wit hth e highes t concentratio no f atypica l elements . I ncas e o f ties , a proces s fo r selecting th e representativ e i s propose d whic hwoul d giv e precedenc e t o th e relevan t characteristic s i nth e following priorit yorder : 1 ) tota l metals , 2 ) tota l halogens , 3 ) tota l o f othe r atypica l elements , 4 ) tota l oxyge ncontent , 5 ) polyme r content . 10 0P.1 4

- » EP Aha s propose d tha t th e representativ e b e selecte d t o

— > reflec t th e highes t concentratio no f atypica l element s s o

— » that , i f subsequen t test s ar e negative , thes e result s can

— > safel yb e generalize d t o al l grou p members . If , instead , th e —>representativ e wer e chose nt o reflec t th e averag e o r media n —>concentratio n o f atypica l element s among product s i nth e —>group , th e significanc e o f negativ e tes t result s woul d b e -¥ unclea r fo r grou p member s wit hhighe r concentration s o f

— > atypica l characteristics . I ncas e a particula r grou p contain s

— > product s whic hgenerall yreflec t a distinc t clustering o f

— > concentration s plu s on e o r mor e product s wit hmuc hhighe r

— > concentrations , th e associate d manufacturer s maychoos e t o

— > divid e th e grou

p o nthi s basi s t o preven t a distan t "outlier "

— » fro mserving a s th e representativ e fo r all . d ) Group s withi nth e Baselin e "Alternative " Categorie s Withi nth e baselin e methano l category , EP Apropose s t o establis htw o fuel/additiv e groups . On e grou p woul d includ e MlO O formulation s (containing a t leas t 96 % methanol ) and woul d b e represente d b

ya designate d MlO O bas e fue l formulation . Th e second grou

p woul d consis t o f methanol/gasolin e blend s containing 50-96 % methanol . Th e latte r grou p woul d b e represente d b

ya designate d M8 5 bas e fuel , reflecting th e expecte d preponderanc e o f end-us e formulation s i nthi s group . Becaus e EP Aha s littl e experienc e wit hformulation s i n th e ethanol , methane , an d propan e fue l families , suggestion s 10 1 

# MP.1 5

requirements , including bot hth e Tie r 1 requirement s fo r chemica l speciatio no f emission s an d th e biologica l testing requirement s o f Tier s 2 an d 3 . Analternativ e approac hwoul d requir e al l uniqu e fue l an d additiv e formulation s t o underg o emissio ncharacterizatio nindependently , applying th e grou p representativ e principl e onl yi nregar d t o biologica l testing requirements . Thi s approac hwoul d provid e mor e definitiv e informatio n onth e emissio nproduct s o f eac hfue l an d additive , bu t woul d increas e programcost s t o individua l manufacturer s and woul d increas e demand s o nscarc e commercia l

— » laboratorycapacity . EP Arequest s inpu t fro mth e publi c on

— > th e likel ybenefit s and cost s o f imposing separat e emissio n

— » speciatio nrequirement s fo r eac hfue l an d additiv e a s compare d

— » t o requiring th e emission s dat a onl yfo r th e designate d grou p

— » representative . C . Groupin

gSyste m Implementatio

nIssue s Th e practica l implementatio no f th e grouping system involve s tw o majo r tasks : th e organizatio nan d administratio n o f grou

p functions , an

d th e developmen t o f equitabl e arrangement s fo r cos t sharing . Backe d b yit s experienc e wit h respec t t o th e TSCAtesting program , EPAbelieve s tha t th e fuel/additiv e industry , unde r th e aegi s o f it s variou s trad e association s o r othe r thir d parties , i s capabl e o f accomplishing thes e task s wit hlittl e o r n o Agenc yassistanc e an d interference . However , effectiv e operation s wil l b e critica l t o th e overal l succes s o f th e grouping provision s o f 10 4 

# Do 0P.1 6

laboratoryanimal s t o fuel/additiv e emissions . Thi s sectio n present s th e method s propose d fo r generating , storing , an d sampling th e emission s t o b e use d i nthes e chemica l an d biologica l tests . Wit ha fewnote d exceptions , emission s wil l b e generate d according t o th e Federa l Tes t Procedur e (FTP ) fo r light-dut yvehicle s (4 0 CF RPar t 86) .
A . Vehicl e Requirement s 

### 1. Vehicle Selection Becaus e th e compositio no f emission s produce d b ya give n fue l o r additiv e i s likel yt o varysomewha t depending o n th e vehicl e involved , a full ycomprehensiv e testing programwoul d nee d t o encompas s th e emission s fro mman yvehicle s representing a complet e cros s sectio no f th e in-us e fleet . I n th e contex t o f th e propose d Reformulate d Gasolin e Rulemaking , EPAsuggeste d tha t t o obtai na statisticall ysignifican t se t o f emissio ncharacterizatio nresult s encompassing th e variet y o f emissio ncontro l system s available , emission s woul d nee d t o b e generate d fro

ma t leas t 2 0 vehicle s fo r eac hfue l unde r evaluatio n(se e Supplementa l Notic e o f Propose d Rulemaking , availabl e i nDocke t # A9 1 02) . Fo r purpose s o f th e routin e registratio no f moto r vehicl e fuel s an d fue l additives , however , EP Abelieve s tha t suc hanextensiv e emissio nsampling an d testing scheme mayno t b e reasonabl e o r necessary . EP Ai s initiall yproposing tha t onl yon e vehicl e b e require d t o generat e th e emission s t o b e use d fo r th e chemica l an d 11 1 

# MP.1 7

thereof , woul d b e chose nt o generat e emission s fo r biologica l testing . Anothe r possibl e variatio ni nth e proposa l woul d allow in-us e vehicle s whic hhav e alread yaccumulate d sufficien t mileag e t o b e employe d fo r generating emission s instead o f requiring mileag e accumulatio no nne wvehicles . Whil e thi s alternativ e woul d reduc e complianc e costs , i t ha s some possibl e drawbacks . Long-termemissio neffect s cause d b yth e fuel s an

d additive s previousl yuse d i nthes e vehicle s coul d alte r th e generate d emission s an d therefor e th e emissio n characterizatio n an d biologica l tes t results . I t woul d the n b e difficul t t o asses s th e exten t t o whic hth e tes t fue l wa s responsibl e fo r th e tes t results . Anothe r drawbac k i s th e absenc e o f informatio no nth e long-ter meffect s o f th e tes t *2f c fue l o r additive . Finally , gaming coul d occu r suc htha t 

## i V ^ . emissio ncharacterizatio ncoul d b e performe d o nman yvehicle s 

# 1 1 

# 1 1 an

d onl yth e bes t result s submitted . Commen t i s requeste d on whethe r in-us e vehicle s woul d b e acceptabl e fo r thi s program .

« • « i EP Aha s als o identifie d a nalternativ e emissio n v
- ' generatio nscenari o whic hincorporate s a numbe r o f th e

possibl e programmodification s describe d above . Becaus e thi s scenari o woul d requir e th e us e o f mor e vehicle s i nth e testing program i n orde r t o increas e th e confidenc e tha t canb e place d i nth e results , method s o f reducing othe r associate d cost s hav e als o bee n identified . 11 7 

# fr€P.1 8

Athir d possibilit yfo r automatio nwoul d involv e th e us e o f anisolate d engin e (i nconjunction , perhaps , wit hth e vehicle' s fue l an

d emissio ncontro l systems ) attache d t o an engin e dynamometer . Sinc e th e inpu t parameter s require d fo r controlling engin e dynamometer s ar e differen t fro mth e whee l spee d driving trac e o f th e chassi s dynamometer , th e light-dut y Urba nDynamomete r Driving Cycl e woul d nee d t o b e translate d t o anequivalen t load-spee d pattern , o r els e analternat e driving cycl e woul d b e required .

— » EP Ai s initiall yproposing t o requir e th e us e o f engin e

— > dynamometer s t o generat e emission s fo r th e heavy-dut yclas s

— > an d chassi s dynamometer s t o generat e emission s fro mlight-dut y

— > vehicles . I nth e heavy-dut ycase , us e o f anengin e

— > dynamomete r fo r emissio ngeneratio ni s consisten t wit hal l

— > existing heav

ydut yemissio ntesting program s an d als o

- » provide s considerabl e cos t advantages . I ncontrast , i nth e

— > light-dut ycase , existing emissio ntesting program s requir e

— » th e us e o f a vehicl e operate d o na chassi s dynamomete r fo r

— » emissio n generation . T o us e anengin e dynamomete r fo r thi s

— > purpose , extensiv e testing woul d hav e t o b e don e t o

— » demonstrat e tha t th e exhaus t emission s wer e th e same a s thos e

— > generate d fro

mth e corresponding light-dut yvehicl e operate d

— > o na chassi s dynamometer . Man ytechnica l problem s woul d hav e —i*t o b e confronte d i nattempting t o isolat e th e engin e an d

— > emissio ncontro l equipmen t fro mth e vehicl e whil e assuring

— » tha t th e representativenes s o f th e emission s woul d b e 12 5 

# o< iP.1 9

— > maintained . Thes e woul d includ e decision s onwhic hvehicl e

— » system s mus t remai nattache d t o th e engin e an d wha t method s t o

— > us e t o terminat e unnecessarysystems ; th e additio no f a

- » flywheel , harmoni c balancer , an d bel l housing t o balanc e th e

— > systemfo r vehicle s equippe d wit hautomati c transmissions ;

- > determinatio no f th e effec t o f detaching transmissio nsensor s

- » suc ha s gea r sensors , clutc hlock/unloc k sensors , an d torqu e

— » converte r spee d sensors ; an d th e translatio no f th e LA- 4

— » chassi s dynamomete r driving cycl e t o anoperating cycl e

— > appropriat e fo r us e wit hanengin e dynamometer .

— > EP Abelieve s tha t th e putativ e cos t saving s associate d

— > wit hth e us e o f a light-dut yengin e dynamomete r rathe r tha na

— > light-dut yvehicl e an d chassi s dynamomete r woul d b e overridde n

— > b yth e cost s associate d wit hresolving thes e problem s an d —>performin g test s t o prov e tha t th e solution s wer e valid .

— ¥ However , EP Ai s ope nt o commen t onth e relativ e cost s an d

— » benefit s o f th e light-dut ychassi s dynamomete r vs . engin e

— > dynamometer , an

d woul d conside r making th e us e o f th e engin e

— > dynamomete r optiona l i nthi s programi f th e comment s provid e

— > persuasiv e evidenc e tha t thi s optio nwoul d b e advantageous .

C . Evaporativ

e Emissio

nGeneratio

n A s discusse d above i nSectio nIII.C , th e evaporativ e emission s o f some fuel s an d additive s wil l b e require d t o underg o emissio ncharacterizatio nan d biologica l testing . Th e 12 6 

# t!« 3P.2 0

additiona l mileag e accumulatio nwil l b e performe d unti l th e emission s o f th e atypica l element s reac hstead ystate . Stead

y stat e wil l b e define d a s th e poin t a t whic hth e mas s o f th e atypica l element s emitte d during th e performanc e o f on e o r mor e Urba n Dynamomete r Driving Schedules/Engin e Dynamomete r Schedule s i s withi n1 0 percen t o f th e mas s o f th e atypica l element s tha t entere d th e combustio nchambe r during th e driving cycles .

— » I n determining whethe r stead ystat e ha s bee nreached ,

— » some les s obviou s pathway s fo r th e los s o r introductio no f th e

— » atypica l element s maynee d t o b e take nint o account . Fo r

— > example , i f th e atypica l compound s coul d b e los t through

— » evaporation , the n th e evaporativ e emission s woul d b e speciate d fo r thes e compounds . I f th e atypica l elemen t enter s th e moto r oi l vi a th e combustio nchamber , th e concentratio no f th e atypica l elemen t i nth e moto r oi l mayb e measure d an d entere d int o th e mas s balance . I f ther e i s reaso nt o suspec t tha t th e ai r use d during combustio no r dilutio nmaycontai nsignifican t quantitie s o f th e atypica l elemen t unde r evaluation , thi s ai r mus t als o b e teste d an d th e problemrectified .

— » EP Ai s initiall yproposing tha t mileag e accumulatio nb e

— > continue d eithe r unti l stead ystat e o f th e atypica l element s

— > ha s bee nreache d o r unti l th e vehicl e o r engin e ha s bee n

— > operate d o n th e atypica l fue l o r additiv e fo r th e equivalen t

— > o f 8 0 percen t o f it s estimate d usefu l lif e (e.g. , 80,00 0 mile s 13 4 

# HP.2 1

— > fo r light-dut yvehicles) . Th e purpos e o f thi s rigorou s

— > requiremen t i s t o ensur e tha t th e emissio nproduct s o f th e

- » element s o f concern ar e know nan d tha t thei r concentration s

— » ar e stabl e whe nth e emission s ar e use d i nsubsequen t testing .

— » I nactua l use , however , fewvehicle s ar e likel yt o b e drive n

— > continuousl yon"atypical " fuel s an d additives . The us e o f

— » suc hproduct s b

yconsumer s i s mor e likel yt o b e intermitten t

- » and/o r limite d t o particula r owner s along th e chai n o f

— » individual s wh o mayow na give nvehicle . Thus , th e propose d

— > requiremen t fo r accumulating mileag e up t o 8 0 percen t o f a —»vehicle' s o r engine' s usefu l lif e (unles s stead ystat e i s

— > reache d a t anearlie r point ) mayfa r excee d th e amoun t o f

— > mileag e and th e concentratio no f atypica l emissio nproduct s —»whic hwoul d generall yb e encountere d i nactua l use . I f so , a

— > lowe r mileag e requirement , perhap s i nth e rang e o f 25-5 0

— » percen t o f th e vehicle' s usefu l life , mayb e mor e appropriat e

— » i npursui t o f th e stead ystat e condition . Comment s ar e

— » requeste d o nthes e issue s an d o nappropriat e mileag e

— > accumulatio n requirements . Dat a o ntypica l consume r usag e

— » pattern s fo r atypica l product s woul d b e particularl yhelpfu l

— » t o thi s decision . I f th e comment s ar e supportiv e o f a chang e

— » i nth e propose d requirements , EP Awoul d expec t t o reduc e th e

— > mileag e accumulatio nrequire d i nth e Fina l Rul e fo r atypica l

— » fuel s an

d additive s t o a mileag e figur e i nth e lowe r rang e

— > mentione d above .

13 5 

# C« GP.2 2


### 3. Additive Concentration Prio r t o emissio ngeneratio nan d testing , additive s ar e t o b e mixe d wit hthei r associate d bas e fue l t o a concentratio n equa l t o tha t recommende d b yth e additiv e produce r a s th e maximu min-us e concentration . On e alternativ e woul d requir e mixing o f fue l additive s i nthei r bas e fuel s a t a significantl yhighe r concentratio ntha nth e recommende d amount , i.e. , t o "dope " th e mixtur e wit hth e fue l additive . Anothe r possibl e metho d o f doping anadditive/bas e fue l mixtur e woul d b e t o significantl yincreas e th e concentratio n o f particula r component s o f anadditiv e produc t (e.g. , th e compound s tha t contai natypica l elements) . Th e primary purpos e o f thes e approache s woul d b e t o enhanc e th e contributio no f th e additiv e produc t (o r th e particula r componen t o f concern ) t o th e emission s produce d b yth e additive/bas e fue l mixture . Thi s woul d facilitat e th e tas k o f detecting an

d analyzing th e additive' s emission s an d distinguishing themfro mth e emission s produce d b yth e bas e fuel . I t woul d als o effectivel yincreas e th e dosag e o f additiv e emission s during biologica l exposure s t o additive/bas e fue l emissions , increasing th e likelihoo d tha t observabl e change s coul d b e detecte d i ncompariso n wit h exposure s t o emission s o f th e bas e fue l alone . EP Aask s fo r commen t o nth e mixing rule s tha t shoul d b e adopte d an d on th e validit yo f doping th e bas e fue l wit hth e fue l additiv e o r activ e ingredient , an d onappropriat e concentratio n level s fo r doping .P.2 3

additio nt o MTBE , bu t wil l requir e appropriat e modification s fo r applicatio n t o ga s phas e samples .
e . PA H an d NPAH Characterizatio n PA H an d NPA H ar e mutageni c compound s whic hhav e bee n designate d a s a topi c fo r stud yb yth e CleanAi r Ac t (Section 202(1 ) (1) ) t o determin e i f thei r emissio nb ymoto r vehicle s shoul d b e regulated . PA H an d NPA H ar e typicall yfoun d i n combustio nemissions , an d thei r identificatio ni nevaporativ e emission s wil l no t b e require d unde r Tie r 1 provisions . I n th e past , PA

H an d NPAH hav e bee nanalyze d primaril yi nth e particulat e phase . However , evidenc e no wsuggest s tha t th e quantit yo f thes e compound s i nth e semi-volatil e phas e a t th e temperature s encountere d i ndilut e exhaus t mayb e important . Fo r thi s reason , PA H an d NPA H wil l b e speciate d i nbot hsemi
volatil e and particulat e phas e emissions .

— ¥ A t thi s time , EP Ai s proposing tha t thes e PA H an d NPA H

— » characterizatio n requirement s b e applie d t o al l organic-base d

- > fuel s an

d additives . However , i t ha s bee nargue d tha t th e

— > combustio no f lowmolecula r weigh t fuel s suc ha s methane ,

— » propane , ethanol , an d methano l wil l no t generat e PAH an d NPAH

— > i nsignifican t quantitie s i f th e vehicle s tha t generat e th e

— » emission s ar e i nprope r operating condition . Comment s an d —¥ supporting dat a ar e thu s requeste d o nth e necessit yo f

— > imposing PA

H an d NPA H characterizatio nrequirement s fo r thes e

— > fuels . 15 2 

# l»&laboratories . The result s o f th e roun d robi n can determin e th e inheren t procedura l variatio nalong wit hth e qualit yo f th e lab s performing th e test . Fo r example , i f four lab s obtaine d simila r result s fo r a know nsolutio nan

d on e lab produce d result s tha t wer e significantl ydifferent , th e reproducibilit ycoul d b e evaluate d b yth e result s o f th e four simila r lab s and th e fift hlabcoul d b e exclude d fromfurthe r testin g unti l th e difference s wer e resolved . EP Aask s fo r comment s o npossibl e arrangement s fo r participating lab s t o performspeciatio nprotocol s i nth e contex t o f a round robi nprogrami norde r t o determin e tes t reproducibilit yand identif ythos e lab s capabl e o f performing th e require d protocol s wit hsufficien t accuracy . T o thi s end , lab s wishin g t o tak e par t i nth e testing programcoul d voluntaril ytes t a vehicle' s emission s o r analyz e an unknow n sampl e provide d b

yEPA . I f th e result s wer e accurate , EP A woul d hav e some assuranc e tha t th e dat a generate d b yth e lab woul d b e acceptable .

c . Audit s EP Awil l reserv e th e righ t t o audi t testing facilitie s involve d i nth e generatio nan d characterizatio no f emission s

. fo r purpose s o f fuel/additiv e registratio ns o tha t th e qualit y
^ — > o f result s i s assured . Suc haudit s woul d b e organize d an d
^ o — » administere d byEP Aa t it s ow nexpense . Th e audi t procedure s coul d includ e a requiremen t tha t facilitie s submi t a complete d 15 7 

# 0*0P.2 5

alternativ e approach . Rathe r tha nusing mathematica l models , a requiremen t coul d b e establishe d fo r analysi s b ya qualifie d chemis t o f th e likel yatmospheri c fat e o f th e emissio nspecie s a s a resul t o f chemica l reactions , deposition , an d othe r processes . EP Awoul d welcome comment s fro m th e publi c onth e suitabilit yo f thes e o r othe r approache s fo r estimating th e atmospheri c reactivit yo f fuel/additiv e emissions .

— > An argumen t canb e mad e tha t requirement s fo r th e

- » modeling o f atmospheri c reactivit ywoul d lead t o redundan t

— » effort s b

yman ymanufacturers , sinc e considerabl e overlap

— > woul d b e expecte d i nth e emissio nproduct s o f differen t fuel s

— > an d additive s (o

r groups ) . According t o thi s argument , th e

— > duplicat e effort s coul d b e avoide d i f EP Aitsel f wer e t o ru n

— » th e model s whe nneeded , using th e emissio nspeciatio ndat a

— > submitte d b

yth e fue l an

d additiv e manufacturers . Unde r thi s

— » lin e o f reasoning , onc e th e dat a onprimaryemissio nproduct s —> ha s bee nsubmitted , EPAwoul d b e i nth e bes t positio n t o

— » compar e th e emissio nprofile s o f differen t fuel s an d

— » additives , an

d t o us e appropriat e model s t o predic t th e

— » implication s fo r atmospheri c reactivity .

- >

— > Whil e thi s argumen t appear s t o hav e some validity , i t

— > als o contain s some drawbacks . First , differen t manufacturers ' —>submission s woul d b e receive d b yEP Aa t differen t times ,

— > interfering wit hEPA' s abilit yt o compar e th e emissio n —>profile s o f variou s fuel s an d additives . Suc hcomparison s 17 0 

# Dts lP.2 6

—»woul d b e difficul t t o performi nan ycase , and i t i s likel y -»tha t EPA' s attentio nwoul d b e draw nt o fuel s o r additive s -»whic happea r t o generat e unusuall yhighconcentration s o f

- » know nprecursor s t o harmfu l transformatio nproducts . A s a

— » result , fuel s an

d additive s whic hmigh t provid e a relativ e

— » advantag e i nterm s o f atmospheri c reactivit ywoul d tend t o b e

- » overlooked . Suc hfavorabl e result s coul d b e importan t i nth e -»overal l evaluatio no f a fue l o r additiv e fo r whic hcertai n

- » advers e effect s wer e als o demonstrated . I naddition , i f EPA

— > wer e t o performth e modeling procedures , manufacturer s woul d

— > los e th e initia l opportunit yt o analyz e an d interpre t th e

— > modeling result s an d conclusion s fo r thei r products . Comment s

— » ar e requeste d o nthi s possibl e approach . Environmenta l partitioning . Example s o f model s whic h coul d b e use d t o evaluat e th e environmenta l partitioning o f emissio nproduct s ar e th e Spatia l Multimedi a Compartmenta l Mode l (SMCM), 16 ' 1 7 develope d b yth e Nationa l Cente r fo r Intermedi a Transpor t Researc ha t UCLA , an d Exposur e an

d Ecotoxicit yEstimatio nfo r Environmenta l Chemical s (E4CHEM ) , 18 ' 1 9 develope d b yGesellschaf t fue r Strahle n(GSF )
1 6 Cohen , Y . e t al . (1990 ) Dynami c Partitioning o f Organi c Chemical s i n Regiona l Environments : AMultimedi a Screening
Leve l Approach . Environ . Sci . Technol . 24:1549-1558 .

1 7 Tsai , W . e t al . (1991 ) Hydroge nPeroxid e Level s i n Lo s Angeles : AScreening-Leve l Evaluation . Atmos . Env . 25B:67-78 .

1 8 Trenkle , R . (1988 ) Fat e Simulatio no f Organi c Substance s i nth e Atmospheri c Mixing Layer . In: Environmenta l Meteorology , K . Grefe nand J . Lobe l (eds) , Kluwe r Academi c Publishers . 17 1 

# (jos ]P.2 7

response s afte r exposur e t o fuel/additiv e emission s a s

— » compare d t o control s (i.e. , animal s expose d t o filtere d ai r

- 4 and , i nth e cas e o f additiv e testing , animal s expose d t o

— » emission s o f th e bas e fuel) . The detectio no f a reproducibl e an d statisticall ysignifican t positiv e respons e t o a t leas t on e concentratio no f emission s mayals o b e interprete d a s a positiv e result . Ame s Revers e Mutatio nAssay . Th e Ame s assa yi s anin vitro tes t fo r mutagenicit yand , b yimplication , fo r carcinogenicity . Th e assaymake s us e o f five mutan t strain s o f th e bacteriu

mSalmonellatyphimuriumwhic hcanno t gro wi n a mediu mdeficien t i nhistidin e du e t o aninherite d inabilit y t o produc e thi s amin o acid . Exposur e t o mutageni c (an d possibl ycarcinogenic ) substance s canelici t revers e mutations , suc htha t th e bacteri a regai nthei r abilit yt o grow i na histidine-deficien t medium . I nthi s test , bacteri a wil l b e expose d t o th e solubl e organi c (semi-volatile ) an d particulat e extract s o f fuel/additiv e combustio nemissions . (Ame s test s wil l no t b e require d fo r evaporativ e emission s o r fo r th e gaseou s fractio no f combustio nemissions. ) Afte r exposure , th e cell s wil l b e plate d onhistidine-deficien t media , bot hwit han d withou t metaboli c activation , an d incubate d fo r a designate d perio d o f time . Th e numbe r o f colonie s (revertants ) growing o nth e plate s wil l the nb e compare d t o th e numbe r o f spontaneou s revertant s i ncontro l cultures . 17 7 

# mP.2 8

suc ha s colchicine . Afte r appropriat e staining fo r labele d DNA , siste r chromati d exchange s wil l b e score d fro mcell s arreste d i nth e second mitoti c divisio nan d th e result s compare d wit happropriat e controls . 

### 2. Developmental

Toxicity(Teratogenicity) Study Thi s stud

yi s designe d t o provid e informatio non potentia l danger s t o th e unbor nwhic hmayaris e fro m inhalatio n exposur e o f th e femal e t o fuel/additiv e emission s during pregnancy . Pregnan t animal s wil l b e expose d t o emission s during th e majo r organdevelopmen t perio d i nth e fetu s (e.g. , day s 6-1 5 fo r rat s an d mice) . Th e dam s wil l b e sacrifice d onth e da yprio r t o norma l parturitio nan d th e uteru s examine d fo r embryoni c o r feta l deaths . Viabl e fetuse s wil l b e examine d fo r skeleta l an d sof t tissu e anomalies . Thes e result s wil l b e evaluate d relativ e t o th e numbe r o f spontaneou s embryoni c o r feta l death s an d abnormalitie s i n appropriat e controls . Th e initiall ypropose d tes t guideline s fo r developmenta l toxicit ycall s fo r tw o differen t specie s t o b e examined . However , EP Aask s fo r commen t onwhethe r on e specie s woul d b e sufficien t fo r th e screening purpose s o f Tie r 2 . 

### 3. Reproductionand FertilityScreen Th e purpos e o f thi s tes t i s t o determin e th e potentia l reproductiv e toxicit yt o adul t mal e an d femal e animal s cause d —> b yinhalatio no f fuel/additiv e emissions . Bot hmale s an d 17 9 

## [114]P.2 9

— > female s wil l b e expose d t o th e emission s throughou t aninitia l

— > 42-da yexposur e period . I n females , vagina l cel l smear s wil l

— > b e examine d throughou t thi s time , t o trac k effect s onth e —>estrou s cycle . A t th e en d o f th e initia l exposur e period , a

— > sufficien t numbe r o f female s wil l b e mate d t o obtai na t leas t

— » te npregnan t females . Histopathologica l examinatio no f th e

— > uteru s an

d ovarie s wil l b e performe d o nth e non-pregnan t

— > females , whil e th e adul t male s wil l b e evaluate d b ygros s an

d

— > histopathologica l examinatio no f th e reproductiv e organ s an d

— > b yassessing th e number , morphology , an d motilit yo f sperm .

- » Pregnan t female s wil l continu e t o b e expose d t o th e tes t

— > atmospher e throughou t th e pregnancy , and wil l b e examined ,

— > along wit hthei r offspring , a t th e time o f birt han d a t four

— » day s post-partum .

A s compare d wit happropriat e contro l animals , positiv e result s woul d includ e change s i nth e numbe r an d typ e o f cell s see ni nvagina l smears , decrease s i nsper mnumbe r o r motilit y o r abnormalitie s o f sper mstructure , and pathologi c change s foun d during gros s o r microscopi c examinatio no f mal e o r femal e reproductiv e organs . Adecreas e i nth e numbe r o r viabilit yo f offspring woul d als o b e evidenc e o f toxicity . 

### 4. PulmonaryToxicityScreen Thi s stud

yinvolve s a six-wee k inhalatio n exposur e o f laboratoryrodent s t o fuel/additiv e emissions , wit hsubsequen t examinatio no f lung tissue s an d cells . Asatellit e grou p o f 18 0 

## QT QP.3 0

changes , unusua l respiration , diarrhea , increase d o r decrease d urination , unusua l vocalization , an d decrease d gri p strength . T o completel yasses s th e neurotoxi c potentia l o f comple x fuel/additiv e emissions , additiona l functiona l an d neurohistochemica l test s woul d b e necessary . Use d alone , th e FONB mayoverloo k advers e effect s a t th e cellua r level . Thus , EP Arequest s commmen t o nwhethe r aninvitro assa yfo r determining th e leve l o f glia l fibrillaryacidi c protei n (GFAP) 22 ' 2 3 shoul d b e require d i nadditio nt o th e FONB t o broadl yasses s sensitiv e neurohistopathologi c effect s i n tes t animals . Anothe r alternativ e i s t o delet e th e FONB an d t o J r addres s neurotoxicit yb yrequiring onl yth e GFAP assay . Th e 4, GFAP assayi s a sensitiv e indicato r o f advers e 

# H neurotoxicologi c effects . Becaus e i t i s aninvitro tes t whic hcanmak e us e o f brai ntissu e harveste d fromexpose d animal s use d i nothe r studies , i t i s als o a relativel y inexpensiv e option . EPArequest s commen t o nthes e alternativ e approache s fo r Tie r 2 testing o f neurotoxi c effects . 

### 6. Optional

Histopathology I f th e Tie r 1 literatur e searc ho r emission s characterizatio nsugges t th e potentia l fo r toxicit yt o othe r

2 2 In: Pesticid e Assessmen t Guidelines , Subdivisio n F , Neurotoxicit yTes t Guideline s (1991) . EPA-540/09-91-123 .

2 3 O'Callaghan , J.P . (1991 ) Quantificatio n o f Glia l FibrillaryAcidi c Protein : Compariso no f Slot-immunobinding Assay s wit ha Nove l Sandwic hELISA . Neurotoxicologyan d Teratology , 13:275-281 . 18 2 

# [i% 3P.3 1

organsystems , the nhistopatholog yo f th e indicate d organ s shoul d b e performed , using th e animal s expose d i nth e pulmonarytoxicit yscreen . Fo r example , i f advers e effect s t o th e live r appea r likely , a s suggeste d fro mth e literatur e o r th e presenc e o f highlevel s o f PAH s i nth e emissions , the ni t

— » woul d b e advisabl e t o performhistopathologyo f th e liver . On

— > th e othe r hand , i f scientificall ysoun d studie s reporte d i n

— » th e literatur e indicat e n o o r veryminima l potentia l fo r

— » hepati c effects , the nlive r examinatio nwoul d no t b e

— > necessary . Othe r organsystem s likel yt o b e o f concer n includ e th e kidney s an d th e endocrin e glands . Thes e additiona l examination s ar e suggeste d becaus e finding s o f potentia l advers e healt heffect s i nTie r 1 migh t requir e follow-u

p a t th e Tie r 3 level , an d i f performe d a s adjunct s t o require d Tie r 2 testing , thes e optiona l histopathology examination s migh t provid e substantia l incrementa l informatio n a t a relativel ylowincrementa l cost . A t a minimum , organ s o f potentia l concer nshoul d b e removed , weighed , an d save d i n storag e fo r potentia l histopathologica l examinatio na t a futur e time . However , th e lengt ho f time whic horgan s canb e store d an

d stil l b e o f us e i s limited . EPArequest s commen t o nwhethe r histopathologica l examinatio no f th e liver , kidneys , an

d endocrin e gland s a s anadjunc t t o th e pulmonary toxicit yscreening tes t shoul d b e require d rathe r than optional . 

### 7. Alternative Testing ApproachP.3 2

likel yan

d tha t exposure s appea r significant , bu t th e dat a ma y stil l b e inadequat e fo r a quantitativel yadvance d ris k assessment . I nthi s case , Tie r 3 testing , targete d t o provid e th e missin g information , woul d b e indicated . I nthi s way , th e principle s an d critica l dat a element s o f th e ris k assessmen t proces s woul d provid e a usefu l guid e fo r identifying significan t informatio ngap s an d determining th e specifi c objective s o f potentia l Tie r 3 testing . However , EPA doe s no t intend t o conduc t a forma l ris k assessmen t a s par t o f it s decisio no nwhethe r t o promot e a fue l o r fue l additiv e (o r group ) t o Tie r 3 . Rather , EP Awoul d evaluat e th e qualit yan d certaint yo f availabl e toxicit yan d dose-respons e dat a an d conside r qualitativel ywhethe r estimate d exposur e weigh s i n favo r o f o r agains t furthe r testing . Onthi s basis , EP Awoul d determin e whethe r additiona l informatio ni s necessaryt o adequatel yasses s th e ris k o f a fue l o r additive . Aforma l ris k assessmen t woul d b e mor e likel yt o b e develope d late r i f ther e wa s a nee d fo r actio nt o contro l o r prohibi t a produc t unde r th e regulatoryauthorit yo f sectio n211(c) . —¥ Th e following sectio ndiscus s th e keyfactor s whic hEP A

— » woul d conside r i nidentifying th e nee d fo r an d conten t o f Tie r

- > 3 testing .

19 1 

# 0<s 3P.3 3

I i — > a . Statistica l Issue s w i - » A s previousl ymentioned , scientifi c judgmen t wil l b e V j f — > exercise d i ndetermining whethe r Tie r 3 test s ar e necessary
' — > and , i f so , whic hones . Animportan t facto r i nsuc hjudgment s —»wil l b e th e interpretatio no f an d significanc e ascribe d t o

— > "negative " result s obtaine d i nTier s 1 an d 2 . Evaluating

— > negativ e dat a (i.e. , no-effec t data ) canb e mor e difficul t

— > tha nevaluating positiv e data , becaus e question s ofte naris e

— » a s t o th e reaso nfo r th e negativ e result : Di d aspect s o f th e

— » experimenta l design(e.g. , verysmal l number s o f animals ) lead

— » t o th e negativ e outcome o r wa s th e tes t substanc e inherentl y

— > o f verylowo r n o toxicity ? ->

- » Thi s specifi c questio ni s addresse d statisticall yb y

- » considering th e probabilit yo f Typ e I an d Typ e I I errors . A

— » Typ e I erro r occur s whe na fals e positiv e conclusio ni s made ,

— » whil e a Typ e I I erro r i s a fals e negativ e conclusion . Th e

— » acceptabilit yo f a specifi c Typ e I I erro r i s relate d t o th e

- » acceptabilit yo f fals e negative s i nth e particula r stud ybeing

— > performed . Fo r example , fro ma toxicologica l perspective ,

— » screening assay s ofte nhav e a relativel yhighprobabilit yo f

— » producin g fals e negativ e outcomes , sinc e some majo r aspect s o f

— > organo r tissu e toxicit yar e no t being examined . Thus , an

— » acceptabl e Typ e I I erro r fo r screening assay s woul d typicall y

- » b e low . However , th e leve l o f Typ e I I erro r considere d

— > acceptabl e shoul d b e tempere d b yth e goa l o f th e study . A

— > highe r fals e negativ e conclusio n(e.g. , Typ e I I erro r o f 0.2 ) 19 2 

# 0*0P.3 4

— > woul d generall yb e acceptabl e i f i t referre d t o aneffec t o f

— > minima l severit ya t a high-exposur e tes t leve l relativ e t o

- » ambien t concentratio nan d i f fewpeopl e wer e likel yt o b e

— > exposed . Th e convers e woul d als o hol d true .

— >

— » Anumbe r o f factor s increas e th e complexit yo f thes e

— » statistica l issues . Fo r example , th e designo f th e stud ywil l

— > influenc e th e Typ e I an d I I level s obtaine d an d th e standar d

- » statistica l method s chosen . Therefore , th e scientifi c qualit y

— > o f th e statistica l analyse s an d thei r relationshi p t o th e

- » experimenta l designar e quit e important . Fo r example ,

- » althoughminimu

msampl e size s ar e specifie d i nth e propose d —>regulations , thes e ar e onl ygenera l guidelines . Variabilit y

— » betwee nlaboratorie s and th e specific s o f th e stud ymethod s

— > mayallo wa decreas e o r requir e anincreas e i nsampl e size .

- » Thes e possibilitie s shoul d b e evaluate d properl ybefor e th e

- > star t o f th e study . —>

— > I nsummary , scientificall ysoun d statistica l analyse s ar e

- » a crucia l par t o f an ygoo d stud

yan d wil l provid e key

— > informatio n fo r EP At o us e i nforming judgment s o nwhethe r o r —¥ no t Tie r 3 testing i s needed . Whil e i t i s no t feasibl e t o

- 4 lis t al l possibl e scenario s an d result s fo r eac hTie r 2

— > endpoint , th e foregoing discussio nelucidate s ho wsome o f th e —> statistica l factor s wil l b e incorporate d int o EPA' s decisions .

19 3P.3 5

b . Exposur e Assessmen t Anumbe r o f th e propose d Tie r 1 an d 2 requirement s wil l provid e EP Awit hinformatio nonpopulatio n exposure s t o fue l an d additiv e emissions . Thi s informatio ninclude s 1 ) historica l and/o r projecte d productio n volumes , 2 ) type s an d emissio nrate s o f speciate d emissio ncomponents , 3 ) estimate d urban , rural , and/o r microenvironmen t exposure s obtaine d throughexposur e modeling approaches , 4 ) evidenc e fo r bioconcentratio n fro menvironmenta l modeling results , and 5 ) possibl e literatur e searc hfinding s onambient , occupational , o r epidemiologica l exposures . A s mentione d above , thi s informatio nwil l b e considere d qualitativel yb yEP Ai n determining whethe r Tie r 3 testing i s needed . Significan t publi c healt hconcern s migh t sometime s b e reveale d b

yth e exposur e informatio nitself . Thi s migh t b e th e case , fo r example , i f ther e wer e ananticipate d releas e i n exces s of , say , 1,00 0 kg pe r yea r o f individua l emissio n compound s (inadditio nt o "criteria " pollutants ) wit hknow n toxicities , o r i f th e anticipate d exposur e scenario s approache d o r exceede d curren t estimate s o f apparentl ysaf e level s o f know

n toxicants . I nth e cas e o f fuel s an d thei r associate d high-volume bul k additives , EPAwil l generall y assume tha t huma nan d environmenta l exposure s wil l b e o f

— > sufficien t leve l an d exten t tha t significan t observe d advers e —> effect s woul d indicat e a nee d fo r follow-u p i nTie r 3 . Thi s exposur e assumptio nreflect s th e highproductio nan d 19 4 

# MP.3 6

consumptio no f thes e products , eithe r a t th e presen t tim e o r a s anticipate d i nth e future . Thus , decision s t o promot e thes e product s t o Tie r 3 woul d b e base d o nth e degre e t o whic h additiona l testin g i s neede d t o clarif yth e result s an d potentia l healt heffec t implication s o f Tie r 1 an d Tie r 2 data . I t canno t b e assumed , o nth e othe r hand , tha t fue l additive s use d i nrelativel ylo wconcentration s o r produce d i n relativel ylo wvolume s woul d automaticall yb e excuse d fro m Tie r 3 . Fo r thes e products , tes t result s indicativ e o f sever e healt heffect s and/o r hig hexposur e level s i ncircumscribe d area s migh t b e caus e fo r escalatio n t o Tie r 3 .

c . Healt hAssessmen t Genera l criteri a fo r evaluatin g th e potentia l publi c healt heffect s associate d wit hfue l an d additiv e emission s woul d includ e 1 ) th e numbe r o f positiv e and.negativ e outcome s relate d t o eac hendpoint , 2 ) th e identificatio n o f concentration-effec t relationships , 3 ) th e statistica l sensitivit yan d significanc e o f suc hstudies , 4 ) th e severit y o f th e observe d effect s (e.g. , whethe r th e effect s woul d b e likel yt o lea d t o incapacitatin g o r irreversibl e conditions) , 5 ) th e numbe r o f specie s involve d i nth e reporte d tests , an d 6 ) th e consistenc yan d clarit yo f apparen t mechanisms , targe t organs , an d outcomes . Additiona l parameter s whic hwoul d influenc e th e decisio n o nwhethe r t o requir e Tie r 3 woul d includ e 1 ) finding s o f environmenta l persistenc e o f th e emission s and/o r th e abilit yo f th e emission s t o accumulat e i n 19 5 

# [itfc|/f OP.3 7

living organisms , 2 ) th e natur e an d amoun t o f know

ntoxi c agent s i nth e emission s stream , an d 3 ) th e observatio no f lesion s whic hspecificall yimplicat e inhalatio na s a n importan t exposur e rout e fo r inducing advers e healt heffects .

— > Thes e criteri a woul d b e evaluate d i nconjunctio nwit hth e —> result s o f th e exposur e assessmen t t o determin e whethe r o r no t

— > highe r leve l testing wa s needed . I nthi s decision , bot hth e

— > biologica l an

d statistica l significanc e o f th e result s o f

— » Tier s 1 an

d 2 woul d b e take nint o account . Generally , —>escalatio n t o Tie r 3 woul d b e considere d whe nremaining —>uncertaintie s abou t th e significanc e o f observe d outcome s

— > and/o r exposure s interfere d wit hEPA' s abilit yt o mak e —»reasonabl e estimate s o f th e attendan t publi c healt hrisks . On

— » th e othe r hand , i f n o statisticall ysignifican t effect s wer e

— » obtaine d a t an

yexposur e leve l i na scientificall ysound Tie r

- > 2 study , an

d i f othe r majo r source s o f concer ndi d no t aris e

— > (e.g. , report s i nth e literatur e o f contradictorytes t result s

— » o r toxi c effect s o f structurall yrelate d compounds ) , the nTie r

— » 3 testing woul d almos t certainl yno t b e require d fo r th e

— > endpoin t i nquestion . Thi s assume s tha t relevant , high
-

— > qualit ystatistica l analysi s ha d bee ndon e t o permi t th e

— > negativ e tes t result s t o b e properl yevaluate d an d

— » interpreted . Th e statistica l analyse s recommende d fo r Tie r 2

- 4 i nanearlie r discussion , including determinatio no f Typ e I

— > an d I I error , shoul d enabl e reasonabl e conclusion s t o b e draw n

— » a s t o th e significanc e o f negativ e findings . Factor s t o b e 19 6 

# [ni]P.3 8

- 4 take nint o accoun t includ e th e toxicologica l natur e o f th e

— > finding s an

d th e exposur e level s use d i nth e test . Fo r

- 4 example , i f th e statistica l analyse s wer e applie d t o a

— > "severe " endpoin t (e.g. , majo r feta l abnormalities , majo r lung

- 4 pathology , etc. ) an d th e exposur e i nquestio nwa s moderate ,

- 4 the n0. 1 woul d b e anappropriat e Typ e I I erro r level . I n

— > contrast , i f a highconcentratio nlimi t tes t cause d a

— » relativel ymino r effec t (e.g. , a smal l chang e i nlung lavag e

- 4 protein ) , a highe r Typ e I I erro r woul d b e allowe d (e.g. , 0.2 ) ,

— * effectivel yincreasing th e chanc e o f fals e negativ e

- 4 conclusions .
Evaluatio n o f Tie r 2 Results . Th e specifi c outcome s whic hwoul d b e considere d positiv e an d negativ e result s fo r eac hpropose d Tie r 2 tes t ar e mentione d briefl yi n th e previou s description s o f Tie r 2 requirement s an d ar e define d an d interprete d mor e precisel yi nth e propose d regulation s whic hfollowthi s NPRMpreamble . Fo r example , thre e primary studie s ar e include d i nTie r 2 whic hrelat e t o carcinogenicit y an d mutagenicity : th e Ames , SCE , an d micronucleu s assays . A s compare d wit happropriat e controls , a statisticall y significan t dose-relate d positiv e respons e i nan yon e o f thes e assay s coul d b e caus e fo r concern , a s woul d positiv e outcome s fo r a t leas t on e concentratio ni ntw o o r mor e o f thes e tests . Suc houtcome s woul d b e indicativ e o f mutageni c risk ; however , depending o n th e interna l an d historica l consistencyo f thes e 19 7 

# [Hf lP.3 9

result s an

d thei r relationshi p t o projecte d exposures , furthe r testing migh t b e require d t o determin e th e significanc e o f thi s mutageni c activit yi nhuma npopulation s expose d b y inhalation . Thes e outcome s woul d als o indicat e tha t th e emission s coul d initiat e some o f th e mechanism s involve d i n carcinogenesis . However , th e productio no f malignanc yi s a multi-ste p process , an d thes e result s woul d generall yno t i n themselve s b e sufficien t t o determin e whethe r th e emission s wer e i nfac t carcinogenic . Thus , additiona l testing migh t b e require d unde r Tie r 3 t o bette r evaluat e th e associate d cance r

- 4 risks . I n contrast , i f n o statisticall ysignifican t result s

- 4 wer e obtaine d i nth e thre e assay s an d n o conflicting result s

— ¥ foun d i n th e literatur e o r i nothe r Tie r 2 tests , the nTie r 3

- 4 follow-u

p fo r carcinogenicity/mutagenicit ywould , i nal l

- 4 likelihood , no t b e required .

T o tak e anothe r example , determinatio no f th e nee d t o furthe r investigat e teratogeni c risk s woul d tak e int o accoun t th e result s o f bot hth e inhalatio ndevelopmenta l toxicit y stud yan d th e reproductio nan d fertilit yassessmen t o f Tie r 2 .

— ¥ Negativ e result s i nbot ho f thes e test s (accordin g t o —¥ statisticall ysoun d principles ) , i f no t refute d b yth e

— > existing literature , woul d argu e agains t requiring additiona l

— ¥ testing fo r developmenta l o r reproductiv e effect s a t th e Tie r

— ¥ 3 level . Positiv e result s woul d includ e a decreas e i n neonata l viabilit yrelativ e t o tha t i ncontro l studies , a significan t chang e i nth e proportio no f viabl e mal e vs . femal e 19 8 

# [m]P.4 0

fetuse s o r offspring , th e presenc e o f sof t tissu e o r skeleta l abnormalities , an

d anincrease d rat e o f embryoni c o r feta l resorption . Othe r positiv e outcome s o f th e reproductio nan d fertilit yassessment , suc ha s abnorma l change s i nsper m structur e o r function , vagina l cytology , o r reproductiv e organ histopathology , woul d b e indicativ e o f hazard s t o th e adul t reproductiv e systems . The nee d fo r additiona l evaluatio n unde r Tie r 3 woul d depend o nth e numbe r o f specie s fo r whic h positiv e result s wer e obtained , th e specificity , severity , an d consistenc yo f results , th e presenc e o r absenc e o f a concentration-effec t relationship , an d th e significanc e o f thes e outcome s i nvie wo f projecte d exposur e scenarios . Th e greate r th e remaining uncertaint yregarding th e ris k o f teratogeni c o r reproductiv e effect s afte r analysi s o f suc h factors , th e highe r woul d b e th e likelihoo d tha t Tie r 3 woul d b e required .

- 4 Similarly , statisticall yvali d negativ e result s obtaine d

— ¥ i nothe r Tie r 2 tests , i nth e absenc e o f significan t relate d

- 4 concern s raise d i nth e literature , woul d sugges t tha t Tie r 3

— ¥ no t b e required . Onth e othe r hand , i f advers e effect s ar e

- 4 foun d a t Tie r 2 and/o r reporte d i nth e literature , EPAwoul d

- 4 determin e i f Tie r 3 follow-u p i s require d b

yattempting t o

— ¥ evaluat e th e nature , severity , an d significanc e o f th e

- 4 finding s i nligh t o f th e likel yexposures . I f EP Adetermine s

— ¥ tha t Tie r 3 testing i s require d t o resolv e th e remaining

- 4 uncertainties , th e Tie r 3 requirement s woul d reflec t bot h 19 9 

# [uQP.4 1

-4positiv e an

d negativ e results . Fo r example , i f th e result s o f

- 4 Tie r 2 wer e positiv e fo r pulmonaryeffect s bu t negativ e fo r

— ¥ neurotoxicit y(accordin g t o criteri a discusse d earlier) , an d -¥ i f thes e result s wer e consisten t wit hth e literature , onl y

- 4 pulmonarytoxicit ywoul d b e a likel ycandidat e fo r Tie r 3

- 4 follow-u

p testing . Acut e Healt hAssessment . Unde r th e assumptio ntha t emission s exposure s wil l generall yb e lowan d thu s mor e likel y t o caus e longer-termeffects , thi s propose d rulemaking doe s no t focu s o nacut e effects . However , th e purpos e o f CA A sectio n21 1 i s t o protec t th e publi c health , whateve r th e exposur e duration , an d potentia l acut e effect s coul d als o b e a consideratio ni n th e Tie r 3 decision . EP Ai s currentl ydeveloping a standardize d metho d o f assessing acut e noncance r healt heffects , an d thi s metho d migh t b e usefu l fo r evaluation s unde r thi s propose d program . Th e ne wmetho d wil l estimat e level s o f exposur e whic har e expecte d t o pos e n o o r minima l healt hris k t o susceptibl e subpopulation s a s wel l a s level s posing incrementall yhighe r risks . Adraf t o f thi s metho d i s expecte d i n earl yfisca l yea r 1993 . Afte r a perio d fo r commen t b yEPA' s Scientifi c AdvisoryBoar d (SAB ) an d th e public , a fina l draf t i s expecte d i nfisca l yea r 1994 . Thus , th e ne wmethodologymayb e availabl e fo r us e i na time frame consisten t wit hth e need s o f thi s program . I f acut e ris k mus t b e assesse d prior , t o th e 20 0 

# [kifrto ]P.4 2

— ¥ A s previousl ymentioned , Tie r 3 requirement s coul d als o

— ¥ includ e additiona l wor k t o improv e th e exposur e estimate s

- > submitte d i ncomplianc e wit hTie r 1 . Th e nee d fo r additiona l —¥ exposur e dat a woul d depend i npar t onth e limitation s o f th e

— ¥ Tie r 1 estimates , an d i npar t onth e natur e o f th e associate d

— ¥ healt heffect s information . Tha t is , highl yprecis e an d

— • accurat e exposur e informatio nwoul d no t b e cos t effectiv e i f

- 4 th e healt hassessmen t wer e base d onlimite d and/o r uncertai n

— ¥ results , an

d vic e versa . —¥ —¥ Th e approac hwhic hEPAplan s t o us e i n determining th e

— ¥ potentia l nee d fo r greate r precisio nan d accurac yi n th e

— ¥ exposur e informatio ni s t o conside r th e slop e o f th e toxi c

— ¥ response . I f th e slop e i s steep withi nth e rang e o f potentia l —¥ huma nexposures , the na smal l chang e i nexposur e i s likel yt o

— ¥ hav e a majo r impac t o nth e eventua l ris k assessment . Greate r

- 4 precisio nwoul d thu s b e require d i nth e exposur e calculation . —¥ I f advers e healt heffect s appea r likel ywithi nth e projecte d

— ¥ rang e o f exposures , improve d estimate s migh t als o b e neede d t o

- 4 determin e th e condition s an d location s unde r whic hthes e

— ¥ exposure s migh t occu r a s wel l a s th e siz e o f th e potentiall y

- 4 affecte d populations . Onth e othe r hand , i f onl ymino r healt h —¥ effect s occu r a t level s wel l above ambien t concentration s an d

- 4 onl ya relativel ysmal l numbe r o f peopl e ar e likel yt o b e

— ¥ exposed , the nadditiona l refinement s o f th e exposur e

- 4 calculation s woul d no t b e warranted .
20 8 uP.4 3

— ¥ Requirement s fo r exposur e assessmen t a t th e Tie r 3 leve l

— ¥ coul d includ e physica l monitoring studie s o r th e applicatio n

- 4 o f mor e sophisticate d modeling techniques , some o f whic har e —¥ describe d i n Sectio nVI.B.2 . However , th e precis e natur e o f —¥ th e requirement s woul d b e strongl yinfluence d b yinteri m -¥ advance s tha t ar e expecte d i nth e growing scienc e o f exposur e

— ¥ assessment . Fo r example , ongoing researc ho nhuma nactivit y

— ¥ pattern s mayb e abl e t o identif ywhic hmicroenvironment s ar e

— ¥ keydeterminant s o f exposur e t o th e emission s o f fuel s an d —¥ additives . I n addition , th e genera l topi c o f gasolin e

— ¥ exposur e i s receiving increase d attentio nb yth e scientifi c —¥ communit ya s a topi c fo r research , i nrecognitio no f th e

— ¥ limite d knowledg e bas e currentl yavailabl e fo r determining th e

— ¥ risk s fro

mmobil e sourc e emission s an d fro m th e us e o f moto r

— » vehicl e fuels. 2 5 Thus , ne winformatio nan d ne wscientifi c

— ¥ methodologie s fo r monitoring an d estimating populatio n

— ¥ exposure s ar e expecte d t o emerg e i na time frame whic hwil l b e

- 4 usefu l fo r guiding th e type s o f exposur e assessment s whic h -¥ migh t b e require d a t th e Tie r 3 level . EP Arequest s comment s o nth e possibl e scenario s and tes t guideline s outline d above , an d solicit s suggestion s o nothe r healt heffec t an

d exposur e studie s whic hshoul d b e considered . Analternativ e approac hfo r determining Tie r 3 testing requirement s woul d permi t th e responsibl e manufacturer s t o

2 5 Journa l o f Exposur e Analysi s an d Environmenta l Epidemiology , January-March , 1992 . 

### 20 9 [dod* JP.4 4

Variou s alternativ e provision s ar e unde r consideratio n fo r thi s purpose . First , th e vulnerabl e companie s coul d b e excuse d fro

m on e o r mor e o f th e program' s requirements . Fo r example , the ycoul d b e excuse d fro mal l Tie r 2 biologica l testing o r coul d b e require d t o conduc t onl ythos e Tie r 2 test s whic haddres s th e endpoint s mandate d b ystatut e (carcinogenicity , mutagenicity , an d teratogenicity) . Anothe r alternativ e woul d b e t o requir e onl yth e Tie r 1 literatur e searc hfo r suc hcompanies . T o ensur e tha t n o smal l additiv e companie s woul d b e financiall ystresse d b yth e regulations , complet e programexemption s migh t b e necessary . However , th e potentia l healt han d environmenta l effect s associate d wit han additiv e produc t ar e generall yno t relate d t o th e siz e o f it s

- 4 producer , an

d EP Adoe s no t favo r thi s alternative . Onth e

- 4 othe r hand , becaus e ris k i s partl ya functio no f exposure , an d

— » potentia l exposur e t o anadditive' s emission s i s relate d t o

- 4 th e volume produce d an d sold , appropriat e measure s o f volume

— ¥ i nconjunctio n wit hothe r relevan t financia l parameter s mayb e

- 4 reasonabl e t o conside r i ndetermining possibl e smal l busines s

— ¥ allowances . Publi c commen t i s requeste d concerning thes e smal l busines s issue s an d alternativ e idea s fo r possibl e smal l busines s allowance s o r exemptions . D . Possibl e Exemptio nfor "D

a Minimis"Factor s
22 0 

# [2o« ]P.4 5

commentary . Instead , th e purpos e o f th e propose d modificatio n proces s i s t o cillo wonl yperson s wh o experienc e unforesee n difficultie s o r accident s i nconducting th e neede d test s t o reques t modificatio no f th e requirement s i n orde r t o avoi d bein g i nviolatio no f th e rule . However , sectio n211(e ) require s th e requisit e (Tier 1 an d Tie r 2 ) informatio n t o b e submitte d t o EPAfo r previousl yregistere d product s withi n thre e year s afte r th e effectiv e dat e o f th e rule . Accordingly , EP Apropose s tha t modificatio nrequest s mus t b e submitte d a s soo na s th e manufacture r i s awar e o f th e difficulty , thu s prohibiting person s fro mwaiting unti l th e deadlin e befor e informing EP Ao f circumstance s whic hmigh t preven t EPAfrom , receiving th e dat a o ntime . X . Confidentia l Busines s Informatio n

. Aprovisio nunde r sectio n211(b ) (2 ) state s tha t th e result s o f healt heffect s test s "conducte d i nconformit ywit h tes t procedure s an d protocol s establishe d b yth e Administrator " shal l no t b e considere d confidential . Thus , informatio nsupplie d t o EP Ai ncomplianc e wit htesting requirement s wil l b e availabl e t o th e public . However , th e statut e specificall ydifferentiate s betwee nhealt heffect s tes t dat a an

d othe r informatio nsubmitte d fo r registration .

- 4 Thus , dat a onproduc t compositio nan d othe r registratio n

- 4 informatio n no t integra l t o th e testing programwil l continu e

— ¥ t o b e hel d i nconfidence .
22 7 

# 0< ]P.4 6 

# tt S 

# 4 EP Arespons e t o OMB' s comment s ar e availabl e i nth e publi c docke t fo r thi s rulemaking .

- 4 Whil e th e cost s o f th e propose d programwoul d b e expecte d

- 4 t o varywidel ybetwee nvariou s fuel/additiv e group s an d among

- 4 individua l manufacturers , a hypothetica l exampl e mayhel p t o

— ¥ clarif yth e propose d scope , time frame , an d cost s o f th e —¥ program . Base d onth e analysi s provide d i nth e regulatory

- 4 suppor t document , a possibl e testing scenari o an d th e

- 4 associate d cost s fo r a hypothetica l grou p o f product s i s

— ¥ discusse d belo wan d summarize d i nFigur e 6 . Th e cost s

— ¥ displaye d woul d b e incurre d i nevaluatio nand testing o f a

- 4 fue l selecte d a s th e hypothetica l grou p representative . Thes e

— ¥ cost s woul d subsequentl yb e share d b yal l o f th e manufacturer s

- 4 wit hproduct s enrolle d i nth e group . Th e requirement s an d -¥ cost s assume tha t th e grou p consist s o f 4 0 fuel s an d additive s

— ¥ whic hcontai nn o "atypical " elements , tha t th e grou p doe s no t —¥ qualif yfo r exemptio nfro mevaporativ e emissio n testing , an d —¥ tha t adequat e existing studie s ar e no t availabl e t o fulfil l

— ¥ an yo f th e speciatio no r biologica l tes t requirements .

— ¥ Therefore , unde r thi s hypothetica l situation , al l o f th e

— ¥ potentia l requirement s o f Tier s 1 an d 2 mus t b e conducted .

— ¥ Combustio nemissio ngeneratio nprocedure s ar e assume d t o b e

— ¥ performe d using a light-dut yvehicle . 

# [>r D 23 0P.4 7

Figur e 6 : Hypothetica l Cos t Scenari o Tie r 1 Requirement s Dat a Researc han

d Analysi s Vehicl e Cost s Combustio n Emissio nGeneration/Speciatio n Evaporativ e Emissio nGeneration/Speciatio n Tota l Tie r 1 Cost s Cos t $ 16,50 0 32,500 27,000 4,000 $ 80,00 0 Tier 2 Requirement s Combustio n Emissio nGeneratio n Biologica l Test s o nCombustio nEmission s Evaporativ e Emissio nGeneratio n Biologica l Test s onEvaporativ e Emission s Tota l Tie r 2 Cost s $ 59,00 0 294,00 0 16,00 0 286,00 0 $ 655,00 0 Administrativ

e an dReportin

gCost s $ 157,00 0 Tota lTie r1 , Tie r2 , Administrativ eCost s $ 892,00 0 Estimate dCost s o f

Tie r3 $ 2-2. 5 millio n Tota lCost s $ 3-3. 5 millio n

23 1P.4 8

^ t - 4 Unde r thi s scenario , th e cos t o f conducting al l

• -¥ requirement s o f Tie r 1 i s estimate d a t approximatel y$80,000 .

( — ¥ O f this , EPAestimate s dat a researc han d analysi s (literatur e

- 4 searc han

d dat a modeling ) cost s t o b e abou t $16,500 , an d

- 4 vehicle-relate d cost s (acquisition/operation/mileag e

- 4 accumulation ) t o b e abou t $32,500 . EP Aestimate s a cos t o f

— ¥ $27,00 0 fo r generatio nan d speciatio no f combustio nemissions ,

— ¥ an d approximatel y$4,00 0 fo r generatio nan d speciatio no f

- 4 evaporativ e emissions . -¥ —¥ Further , EPAestimate s th e cost s o f conducting al l Tie r -¥ 2 tes t requirement s t o tota l nearl y$655,00 0 unde r thi s

— ¥ hypothetica l example . Including set-u p costs , combustio n —remissio n generatio ncost s ar e estimate d a t abou t $59,000 ,

— ¥ whil e biologica l testing o f combustio nemission s i s estimate d

- 4 at . nearl y$294,000 . Th e cos t o f generating adequat e

- 4 evaporativ e emission s t o conduc t al l Tie r 2 screening test s

— ¥ woul d b e approximatel y$16,000 , an d conducting Tie r 2 test s o n

- 4 thes e emission s i s estimate d t o cos t $286,000 . -¥ —¥ Th e administrativ e cost s fo r organizing an d administering —¥ th e grou

p an d fo r reporting th e Tie r 1 an d 2 result s t o EP Ai s

— ¥ judge d t o b e nearl y$157,000 . Addin g thi s t o th e Tie r 1 an d

— ¥ Tie r 2 cost s provide d above yield s a tota l cos t o f

- 4 approximatel y$892,00 0 fo r th e grou p a s a whole . Assuming

— ¥ thes e cost s ar e incurre d ove r a three-yea r perio d an d ar e

— ¥ divide d equall yamong th e 4 0 product s i nth e group , th e cos t 

### 23 2 

### [p-n}P.4 9

- 4 t o a manufacture r wit ha singl e produc t i nthi s grou p woul d b e

- 4 abou t $7,30 0 annuall yfo r thre e years , o r $22,00 0 i ntotal . -¥

— ¥ Le t u s assume furthe r that , withi n1 8 month s o f receiving

— ¥ th e group' s report , EPAdetermine s tha t th e submitta l i s

- 4 complet e an

d tha t th e require d Tie r 1 an d 2 evaluation s hav e -¥ bee nadequatel yperformed . However , a numbe r o f healt h

— ¥ concern s ar e raise d b yth e results . Th e literatur e searc h

- 4 suggest s a highpotentia l fo r toxi c live r effect s t o b e cause d

— ¥ b ychroni c exposur e t o th e combustio nemission s o f fuel s

— ¥ simila r t o thos e i nth e group , and th e Tie r 2 result s indicat e —¥ a nee d fo r furthe r evaluatio no f possibl e carcinogeni c an d —¥ pulmonaryeffect s o f thes e emissions . I naddition , a larg e

- 4 an d widesprea d populatio ni s expecte d t o b e expose d t o th e —¥ emission s o f product s i nthi s group . Thus , EPAdetermine s

- 4 tha t mor e rigorou s testing i s necessaryunde r Tie r 3 t o

- 4 clarif yth e potentia l risk s pose d b ythi s grou

p o f products . -¥

- 4 Unde r thi s hypothetica l scenario , tw o test s ar e likel yt o

- 4 b e require d t o addres s th e identifie d area s o f concern : a

— ¥ two-yea r combine d chroni c toxicity/carcinogenicit ystud y

— ¥ conducte d i ntw o species , an d a metabolis mstud yt o elucidat e

— ¥ th e potentia l carcinogeni c mechanisms . The grou p i s give n

— ¥ thre e year s i nwhic ht o complet e thes e tests . Th e tota l cost ,

— ¥ including cost s fo r emissio ngeneratio nan d biologica l

- 4 testing , i s estimate d a t 2 t o 2. 5 millio ndollars . Whe n

— ¥ divide d equall yamong th e 4 0 product s i nth e grou p an d spread 23 3P.5 0 

# J

* — ¥ ove r th e three-yea r complianc e period , th e Tie r 3 testin g cos t U| - 4 pe r produc t i nthi s grou p woul d b e i nth e rang e o f $17-21,00 0

— ¥ annuall yfo r thre e years .

- 4

— ¥ I nsum , EPAestimate s tha t th e tota l cost s t o thi s —¥ hypothetica l grou

p woul d rang e fro

mapproximatel y3 t o 3. 5

- 4 millio ndollars , incurre d ove r a seve no r eigh t yea r time

— ¥ period . Th e tota l cos t fo r eac hproduc t woul d rang e fro m

- 4 abou t $75,00 0 t o $87,500 , averaging abou t $10-12,00 0 pe r year . Thi s propose d regulatio nwa s submitte d t o th e Offic e o f Managemen t an

d Budge t (OMB ) fo r revie wa s require d b y Executiv e Orde r 12291 . An ywritte ncomment s from OMB and an

y EP Arespons e t o OMB' s comment s ar e availabl e i nth e publi c docke t fo r thi s rulemaking . XTV . Complianc e withRegulator y Flexibility

Ac t Unde r Sectio n 60 5 o f th e RegulatoryFlexibilit yAct , 5 US C 60 1 e t reg. , th e Administrato r i s require d t o asses s th e economi c impac t o f thi s propose d regulatio no n smal l busines s entities . Accordingly , a RegulatoryFlexibilit yAnalysi s (RFA ) ha s bee nprepare d an d i s availabl e i nth e publi c docket . Th e RFAcompare s th e estimate d financia l effect s o f th e propose d program s onlarg e an d smal l companie s a s define d b y th e Smal l Busines s Administration .

23 4 

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