P. 1 

# OAR Box 1834 Prepped by Keeia Richards

Document

Number: 

# 54 ) IV-H-0 8 Docket Number: 

# A-90-0 7

Printed 11/10/2008 2:14:35 PM Sheet 54 of 61p ? J5T-//-08 

## 5. i s f JJUU L 

# H FINAL RULE : FUEL S AN

D FUE L ADDITIVE S REGISTRATIO

N PROGRA

M 

# u u MA

Y2 £ » J» M 

# \3\ EP A AI R DOCKE T


## Briefing for the Offic e o f Managemen

tan d Budge t Ma y 3 , 1994

Regulatio n Developmentand Suppor tDivisio n Offic e of Mobil e Source s Offic e of Ai r an d Radiatio n 

### U.S . Environmenta

l Protectio n Agenc

y 

# mP. 3

r OVERVIEW Backgroun d
• Revie w o f

Statutor y Provision s
• Rulemakin g Histor

y Progra m Scop e • Applicabilit

y • Program Focu s • Scop e of

Requirement

s • Timin g of

Requirement

s Specia l Provision s • Groupin g System • Alternativ e Tie r 2 Provisio n • Small Busines s Provision s • Othe r Specia

l Provision s Economic s ___

. • Program Costs Summar yP. 4



# BACKGROUN DP. 5 STATUTOR

Y PROVISION S Clean Ai r Ac

tSection s 21 1 (a) and (b ) - 197 0
• Authoriz e EP

A t o designat

e type s o f fuel s or fue l additive s (F/FAs) , an

d t o requir e designate dF/F

A product s to b e registere dby their manufacturer s a s aconditio n fo r thei r sal e o r commerc e
• Gran t EPA discretionar

y authorit y to require producer s to conduc t test s an dsubmi t

informatio n on :

- Compositio n o

f F/F A emission s

- Effect s o

f F/F A emission s on designate dhealt h parameter s

- Impac t o f F/F A emission s o n th e publi c welfar e

- Effect s o

f F/FA s on emissio n contro l systemperformanc e
• An y regulator

y contro l base do n such informatio n require s follow-o n rulemakin g under

Sectio n 211(c ) Clean Ai r ActSectio n 211(e ) • 1977
• Make s implementatio n o f th e testin g requirement s mandator y andset s complianc e deadline s fo

r th e "requisit

e data" :

- Fo r alread y registere dF/FAs : thre e year s fro mfina l rulemakin g

- Fo r new products : prio r

t o registratio n
• Authorizes

_specia l provision s for :

- Smal l businesse s

- Cost-sharin g arrangement s

- Avoidanc e o

f duplicativ e informatio nP. 6 RULEMAKIN G HISTOR Y 197 0 Congres s enact s CA A section s 211(a)-(d) . 1975 EP A implement s basi c F/F

A registratio n progra

munder section s 211(a) an d211(b)(1) , bu t

doe s no t implemen t F/F A testin g progra

m authorize dby sectio n 211(b)(2) . 197 7 Congres s enact s sectio n 211(e) , makin g implementatio n o f 211(b)(2 ) mandator

y withi n one year . 197 8 ANPR

M published . But

n o proposal o r

fina l rul e follows . 198 9 Citizen s group sue s EP A fo r failur e to promulgate 211(e) . EP A enter s into consent

decre e settin g arulemakin g schedul e 199 0 ANPR

M publishe d (5 5 F

R32218 , Augus t

7 , 1990) . 199 1 EPA engage s consultant to investigat

e feasibilit y o f usin g Reg Ne g fo r th e F/F A progra mrulemaking , but

find s insufficien

t interes t among key parties . (February-May , 1991 ) 199 2 NPR

M publishe d(5 7 F

R13168 , Apri l 15 , 199 $ 199 4 Notic e to Reopen Commen t Perio d(5 9 F

R8886 , Feb . 24 , 1994 ) Final Deadlin e fo r Promulgation : Ma y 27,199 4P. 7



# PROGRA M SCOP EP. 8 APPLICABILIT Y Al l F/FA s designate dfo

r registratio n ar

e subject to th e testin g progra

m

- Complianc e require dfo

r existin g F/FA s t o retai n registrations . (T o date , about

2,00 0 producer s hav e registere dove r 7,20 0 fue l andadditiv e products. )

- Complianc e als o require dfo r new F/FA s to becom

e registere d Currently , only gasolin e an ddiese l F/FA s ar

e designate d

- Testin g progra

momit s leade dgasolin e products , du e t o upcomin g ba n underCAA§211(n )

- Off-roa dF/FA s exclude da

t thi s tim e

• Designatio n o

f othe r "alternative " F/F

A familie s i s planned , i.e. , methanol , ethanol , CNG , LPG

- Provisio n wil l b e made to ensur e thei r market acces s wil l no t

b e interrupte ddurin g phase-i n perio d A numbe r o f specia l provision s (discusse d later) impac t th e applicabilit

y o f variou s requirement s to particula r F/FA s or type s o f F/FA sP. 9 PROGRAM FOCU S
• Basi c tenet s andstructur e o f th e progra

mar e consistent

wit h th e NPR M
• Majo r focus :

- Determinatio n o

f potential advers e healt

h effects o f F/F A exhaus t and evaporativ e emission s

- Mai n thrus t

i s evaluatio n o

f effect s of

inhalatio n exposur

e t o th e whol e complex emissio n mixture s generate dby F/FA s in use , no t toxicolog y of

individua l pure compound s
• Underlyin g principles :

- Use s tiere devaluatio n approach , emphasizin g short-ter mtestin g wit

h allowanc e fo

r mor e rigorou s studie s a s require d

- Recognize s adequat

e existin g data , i

f available , in lie

u o f requirin g duplicativ e testing . "Adequacy " depend s o n documente dexposur e scenarios , technica

l procedures , statistica

l methods , et

al .

- Provide s fo

r voluntar y groupin g andcos t

sharin g b y producer s o

f simila r F/FAs , t o furthe

r reduc e duplicatio n an

dcost s

- Smal l busines s allowance s andother specia l provision s als o help reduc e complianc e burden s
• Approac h t o other

statutor y requirements :

- Welfar e effect s addresse dprimaril y throug h literature searc h

- Emissio n contro l systemeffect s addresse dprimaril y throug h existin g regulator y mechanism s (e.g. , waive r program )

- On acase-by-cas e basis , EP A retain s th e right

to requir e specifi c testin g in thes e area sP.1 0 SCOP E OF REQUIREMENT S Requirement s hav e bee n streamline din compariso n wit h NPR M

- Propose dmodelin g requirement s (quantitativ e exposure , atmospheri c reactivity , an

denvironmenta

l partitionin g analyses ) delete d

- Propose dserie s of

42-da y biologica

l test s replace dwit

h asingl e 90 - da y protocol .

- Technica

l change s t o simplif

y an dcoordinat

e specifi c endpoint

test s Evaluatio n Tier s (Figur

e 1 ) Tie r 1 :

- Literature searc h on health/welfar e effect s o

f emission s

- Qualitativ e exposur

e analysi s base do n F/F

A production/us e

- Emissio n Characterizatio n (Figur e 2 ) Tie r 2 : Short-ter

mtoxicolog y testin g

- In general , entail s 90-da y (subchronic ) inhalatio n exposure s

- Animal s expose dt o whole , "real-time " vehicle/engin e combustio n emission s and(whe

n indicated ) t o evaporativ e emission s generate d fro mafue l tan k o r vesse l

- Evaluatio n of

genera l organ/systemi c toxicity , wit h specia l endpoint assessment s (carcinogenicity , mutagenicity , developmenta l and fertilit y effects , pulmonar

y andneuro effects )

- A singl e exposur

e scenari o feasibl e fo

r al l endpoint s (Figur

e 3 ) Tie r 3 : Follow-up testin g (if needed ) on acase-by-cas e basis , targete d t o identifie darea s o

f concer nP.1 1

Figur e 1 . Overvie wo f Evaluatio n Tiers '

Star t 

# I Basi c Registratio n Dat a 

# J Tie r 1 Literatur e searc h Characterizatio n o

f emissions b Exposur e analysi s 

# J Tie r 2 b 90-da y subchroni c inhalatio n stud y wit h additiona l test s fo r carcinogenicity , mutagenicity , teratogenicity , reproductiv e toxicity , an d neurotoxicit y 

# I EP A evaluatio n o

f Tier s 1 & 2 dat a an d determinatio n o

f nee d fo r Tie r 3 Additiona l testin g neede d " Tie r 3 

# • Curren t Requirement s complet e ° Additiona l testin g no t neede d

a Thi s chart shows th e genera l requirement s fo r mos t F/FAs . Specia l provision s ar e no t depicted . Require d unles s adequat e dat a exist . c EP A retain s th e authorit y t o requir e additiona l testin g i f ne wconcern s arise .Figur e 2 . Emissio n Characterization/Measuremen t Requirement s Emissio n Typ e Combustio n Emissions : Vapo r Phas e Semi volatil e Phas e Particulat e Phas e Evaporativ e Emissions: * Evaporativ e Emissio n Generator * Basi c

Emissions " Speciate d Emission s

Hydrocarbon s Ketone s an d Aldehyde s Alcohol s

an d Ethers " Polycycli c

Aromati c Hydrocarbon s (PAHs) c Nitrate d

Polycycli c Aromati c Hydrocarbon s (NPAHs ) c Atypicals d

X
X X X X X X X

X X

X X
X ' X X X

a Basi c emission s = tota l hydrocarbons , carbo n monoxide , oxide s o f nitrogen , an d particulate s (se e Sectio n VII.B.2. a below ) b Require d i f alcohol s o r ether s exis t i n th e uncombuste d fue l o r additive/bas e fue l mixture . c No t require d fo r methan e (CNG , LNG ) o r propan e (LPG ) . d Manufacturer s o f atypica l product s mus t examin e al l emissio n fraction s fo r th e measurement an d identificatio n o f potentia l atypica l species . •Onl yapplicabl e t o F/FA s require d t o measur e evaporativ e emissions . £ Evaporativ e emission s ar e t o b e generate d usin g a n evaporativ e emissio n generato r a s describe d i n Sectio n VI.C . 9 Th e onl ybasi c emissio n require d t o b e measure d fo r evaporativ e emission s i s tota l hydrocarbons .2 5 9 +2 5 d *

1-2__ 1 Acclimatizatio n An d Cullin g Figur e 3 . Suggeste d Timin g an d Organizatio n o f Tie r2 Studie s Exposure Analysi s 

# t

_ _ Exposur e fo r Subchroni c Stud y

(Genera l Toxicit y an d Othe r Endpoints ) 5d\- 5 ? Perfuse d fo r neuro , testis , kin g histolog y 20d" + 2 0 ? Fixe d fo r genera l histolog y J L J L 1 0 1 1 1 2 1 3 1 4 

# 1 5(^+5 . Tissue s (o r GFAP . MN , SC E 2 5 * Exposur e fo r Fertility/Teratolog y Studie s (Exposur e end s a t Gestatio n Da y 15 ) Estrou s Cycl e Analyse s Matin g Termination . (w / abov e d" ) (Gestatio n Da y 20 ) Fetal/Uterin e Analysi s 20-2 5 pregnancie s NOTE : Thi s diagra m illustrate s testin g a t on e dosag e level , usin g 7 5 animals . Complet e Tie r2 require s testin g a t fou r dosag e level s (high , medium , low , an d control) , requirin g a minimu m o f 30 0 animal s ( 4 x 75) , plu s a n additiona l grou p o f 2 0 animal s expose d a t th e hig h dos e an d hel d 2 8 day s fo r stud y o f recover y potential . Timin g o f Salmonell a mutagenicit y assa y i s independen t o f thi s testin g scenario . 

## IP.1 4 TIMIN G OF REQUIREMENT S
• §211(b ) require s emission s characterizatio n an dhealt h effects tes t

data , an dmandate s certai n healt

h effect s endpoints :

- Thes e mandator

y requirement s ar

e incorporate din Tier s 1 and2
• However , §211(e ) say s tha t th e "requisite " dat amus t

b e submitte dfo

r existin g F/FA s withi n 3 year s o f promulgatio n o

f rul e

- Difficul t fo r al l manufacturer s to complet e Tier s 1 an

d2 in 3 years , give n numbe

r o f F/FA s (o r groups) , complexit

y o f testing , current shortag e o f labs , an dtime fo r la b capacit y t o com e on lin e
• Thus , fo

r existin g F/FAs , fina

l rul e ha s th e following timin g provisions :

- "Requisit

e data" , du e withi n 3 years , include s Tier 1 plu s acontrac t wit h aqualifie dla

b t o complet

e Tier 2 .

- Al l Tier

2 result s ar

e du e withi n 3 additiona

l years . Failur

e t o meet thi s deadlin e risk s financia l penaltie s and/or

los s o f registratio n

- Note: April

22nd draft rule does not

contain this provision
• Fo r F/FA s no t

registered , fina

l rul e distinguishe s tw o type s (se e Fi g 4) : "Registrable " product s = F/FA s which fi t criteri afo

r groupin g wit

h currentl y registere dfuel s an dbulk additive s i n sam

e fue l famil y

- Ca n register without delay ; sam

e deadline s a s existin g F/FA s

- Assure s compatibilit

y wit h othe r rule s (e.g. , RFG , detergents ) "New " product s = F/FA s no t fitting criteri ato group wit h registere d fuel s an dbulk

additive s i n sam

e fue l famil y

- Mus t complet e al l tes t requirement s befor

e registratio n

- Include s an

y Tier 3 testin g whic h ma

y b e prescribe dP.1 5
Figur e 4 . Determinatio n o f F/FA Registrabilit y an d Complianc e Tim e Requirement s 

# ©

YE S

1 YE S

' Registere d an d Registrabl e F/FAs :

- Tie r1 complianc e withi n 3 yrs . o f promulgation ; Tie r2 complianc e withi n 6 yrs . o f promulgation e

- Additiona l tim e provide d fo rTie r3 , i f prescribe d

- Conditiona l registratio n continue s durin g thes e complianc e period s j * An y fue l o radditiv e (bul k o r Registere d a s o f effectiv e dat e o f fina l rul e N O " Fit s criteri a fo rgroupin g wit h a currentl y registere d fue l o rbul k

additiv e i n th e sam e fue l family b

aftermarket) . . u Th e ter m "currently " refer s t o th e dat e o n whic h EP A re < applicatio n fo rth e fue l o rfue l additiv e i n question . cAfte rthi s tim e period , a manufacture ro f a registrabl e f u ca n usuall y rel y o n dat a previousl y submitte d fo ra simi l i n th e sam e group . M f i IN U 1

' Ne w (No t Registrable ) F/FAs :

- Complianc e wit h al l testin g requirement s (includin g Tie r3 , i f prescribed ) prio rt o registratio n

reive s th e registratio n e l o radditiv e a rregistere d produc

tP.1 6



# SPECIA L PROVISION

SP.1 7 GROUPIN G SYSTE

M Objective s
• Enable s manufacturer s o f chemically simila

r products , on avoluntar

y basis , to shar

e cost s o f progra mcomplianc e
• Minimize s duplicativ e effort s andredundan t informatio n
• Ease s deman do n limite dlaborator y capacit y
• Decrease s volume o

f material fo

r EP A revie w andanalysi s Genera l Principle s
• Group s ar

e define dbase do n compositio n of "raw " F/FA s
• Fuel s andrelate dfue

l additive s ar

e groupe dtogether , wit

h additive s sorte daccordin g t o th e characteristic s of th e associate din-us e additive/fue l mixtur

e
• Producer s o

f F/FA s i n th e sam

e group ca

n conduc t

cooperativ e evaluatio n andtestin g usin g arepresentativ e produc t selecte daccordin g t o EPA rule s
• Tes t result s fo r representative s wil l b e applie d t o al l grou p member s Framewor

k (se e Figure 5 )
• Eac h F/F

A i s firs t sorte dinto aFuel/Additiv e Categor y withi n th e applicabl e "fue

l family "
• Fue l familie s reflec t

basi c chemical/physica

l propertie s andengin e usage , e.g. , unleade dgasolin e anddiese l families . Fo r eac h fue l family , specification s fo

r a n averag e "bas e fuel " are given .(Groupin g System , Cont'd )

• Categorie s reflec t

th e degre e o

f similarit y of agive n F/F

A to th e bas e fue l i n it s family . Wit

h som e exceptions , categor

y definition s are :

- Baseline : F/FA s havin g n o element s other tha n thos e in th e bas e fue l (generally , only C,H,0,N, S ar e allowed) , and conforming to certai n limit s on som

e constituent s

- Non-baseline : F/FA s hav e sam e element s as permitte di n Baseline , but excee dconcentratio n limit s

- Atypical : Contai n element s no t include di n Baselin e
• Eac h categor

y ma y b e furthe

r subdivide dinto one o r

mor e F/F A groups , dependin g o n th e variabilit y of F/FA s withi n th e categor

y
• Withi n eac h group , either the bas e fue

l or amembe r F/F A i s specifie d t o represent

th e group i n testin g
• Usin g th e groupin g criteri aand12/31/9 2 F/F A registratio n database , a total o f 11 0 group s ar

e projecte d(se e Figur

e 6 ) Organizatio n o

f F/F A Group s
• Producer s expecte dt o determin e appropriat e group s fo

r .thei r F/FA s • Enrollment

andadministratio n o

f group s to b e brokere db y industr y
• Fo r dispute s relate dto cos t

sharin g andreimbusement arrangements , TSC A arbitratio n procedure s ca n b e use da

t manufacturers ' reques tP.1 9
Figur e 5 . Fuel/Additiv e Classificatio n Hierarch y

Fue l Familie s Conventional : Alternative : Gasolin e

Diese l Methano l Ethano l Methan e (CNG , LNG ) Propan e (LPG ) 

# t Fuel/Additiv e Categories :

- Baselin e

- Non-baselin e

- Atypica l 

# i Fuel/Additiv e Group s
Grou p Representative(s )P.2 0

Figur e 6 : Estimate d Group s Pe r Fuel/Fue l Additiv e Categor y

F/F ACategor y Baseline 1

Non-Baseline 1 ' 2
Atypical 3 Fue l Famil y Gasolin e 1 Grou p 30 7 Manufacturer s 1,5 8 6 Product s

, 9 Group s 12 0 Manufacturer s 47 6 Product s 5 6 Group s 1 4 6 Manufacturer s 29 3 Product s Diese l 1 Grou p 8 7 Manufacturer s 49 6 Product s 2 Group s 1 Manufacture r 2 Product s 4 1 Group s 11 2 Manufacturer s 21 3 Product s 1 Exclude s dat a fo r manufacturer s who , unde r smal l busines s provision s o f thi s rule , ar e exempte d fro mtes t requirement s fo r thei r baselin e an d non-baselin e product s (i.e. , exclude s manufacturer s < $5 0 millio n i n sales) . 2 Non-baseiin e product s ca n fal l int o mor e tha n on e grou p dependin g upo n th e numbe r o f oxyge n compound s the ycontain . Thus , the yar e counte d multipl e time s i n tri e tabl e dependin g upo n th e numbe r o f group s the yfal l into . 'Includes dat a fo r manufacturer s wh o ar e exempte d fro ma portio n o f th e tes t requirement s fo r thes e product s unde r th e smal l busines s provision s o f thi 3 rul e (i.e. , include s manufacturer s < $1 0 millio n i n sales) .P.2 1 ALTERNATIVE TIER2 PROVISIO N

• In som e cases , EP

A ma y b e abl e to define specifi c healt h effec t concern s insteadof

, or in additio n to , th e broad screenin g studie s o f Tier 2 . Fo r example :

- Som e Tier 2 test s ma

y no t b e reasonabl e fo

r certai n F/FA s (e.g. , cancer test s fo r CNG)

- EPA' s concern s abou

t acertai n F/F

A ma y alread y b e narrowe ddown

—more rigorou s test s neede djus t i n on e o r tw o area s

- EPA ma

y b e concerne dabout

a n endpoint no t specifically targete din Tie r 2 (e.g. , hepatotoxicity , endocrin e toxicity ) —additiona l evaluation s don e i n conjunctio n wit h Tier 2 coul dsav e cost s in th e lon g ru n

• Thus , fina

l rul e retain s EP

A authorit

y t o modif

y Tier 2 testin g requirement s fo

r specifie dF/F

A group s

• F/F A manufacturer(s ) wil l b e notifie dof require dalternativ e tes t progra mwithi n nin e month s o

f promulgation .

• EP A ma y contac t manufacture

r a t alater time , but complianc e wit

h alternativ e tes t

progra mwil l the n b e voluntary .P.2 2 SMALL BUSINES S PROVISION S Authority : §211(e ) authorize s EP A t o define asmal l busines s fo r thi s rul e andt o provid e modification s or exemption s fo

r such companie s Definition : Compan

y wit h annua l sale s les s tha

n $5 0 millio n
• Base d on examinatio n of distributio n o

f registere dcompanie s by sales : ten dto cluster

unde r $50 M an dover $10 0 M (se e Figure s 7 an d8 )
• Thi s definitio n result s in greater numbe r o f "small " companie s tha

n SB A definition s Provisions : Depen do n typ e o f produc t an dfurthe r sale s breakdow n 1 . Al l smal l companie s ar e exemp t fro mstandar d Tier 1 andTier

2 responsibilitie s fo

r thei r baselin e an

dnonbaselin e product s Rationale : EPA' s dat aneed s fo r such product s wil l b e furnishe dby larger companie s wit

h product s in sam

e F/F A groups . 2 . Companie s wit

h sale s les s tha

n $1 0 millio n als o hav e reduce d responsibilitie s fo

r atypica l product s —mus t

d o Tier 1 only Rationale :
• Ful l exemptio n woul dofte n resul t i n EP A havin g n o dat afurnishe d fo r thes e F/FAs , becaus e larger companie s les s likely t o hav e product s i n atypica

l group s
• Still , requirement s fo

r atypical s ar

e relativel y high , especiall y sinc e there ar e fewe r groupin g (cos t

sharing ) opportunitie s
• Compromis e provisio n fo r atypica l product s of

smalles t companies : n o bi o tes t

data , but emissio n characterizatio n andli t searc h dat a mus t b e provide dfo

r EPA' s initia

l evaluation . I

f warranted , toxicologi c testin g coul dstil l occur a t Tier 3 .P.23

Figur e 7 

### Fue l Manufacture r Annua l Sale s Distributio n Manufacturer s o f Leade d Product s Exclude d Figur e 7 a

_ (0 V) " 5 3 C C < & "o c

. 2

_ _ Figur e 7 b 0 5 1 0 1 5 2025303540455055606570758085909 5 100 Cumulativ e Percen t o f 63 8 Companie s

<1 0 10-4 9 50-9 9 Annua l Sale s ( $ Millions ) •>10 0 Figur e 7 c 12 0 10 0 - c o I 8 0 < 2 6 0 %

~ 4 0 3 C 2 0 -

-

-

_. . ___..

_ Fue l Mfrs . Earnin g < $100 M Pe r Yea r • • * $5 0 MILLIO N _ / J_~- "

_ _»...--_ - • _--*"^* ^ __„. • _.—«-— » ^

_ _• • —T , i .. . 1 . L1 1 1 1 1 1 1 1 1 1 1 • 1 0 2 0 3 0 4 0 5 0 6 0 7 0 8 0

Cumulativ e Percen t o f 52 5 Comoanie s < $10 0 M M 9 0 100P.2 4 Figur e 8 Fue l Additiv

e Manufacture r Annua l Sale s Distributio n Manufacturer s o f Leade d Product s & Relabeier s Exclude d Figur e 8 a

( A
_ 3 C C < O Q ---$io,oeo - -$100-- - $1. 0

_

J I I Figure 8 b

Figur e 8 c - i 1 1 i i i • ' ' 10 20 3 0 4 0 5 0 6 0 70

Cumulativ

e Percen t o

f 45 6 Companie s

<1 0 10-4 9 50-9 9 Annua l Sale s ( $ Millions ) 8 0 9

0 10

0

• 20 0 epan E 15 0 < 3 < M o 1 1 0 ° E 3 Z 5 0 n ^ ^ ^ ____________B_______

i ^^^E____ H

_____________________

_ ^^^^^^ H —————————————————_

H

____________________

H 

### ^^^^^ H

_____________________

_

_____________________

_ 

# ~ _____ _I ^^^^^^^^^^^ ^ 

### ^^^^^^ l ^^^^^^^__^^^________

i



# _________ • ^m|^ _

____________________

[ _____________________ ! ___________H_______

I _____________________ i 

# _____i___ i ___________

! ->10 0
100 In 8 0 c o % » 6 0 3 W 4 0 | -

_ 3 C < 2 0 Fue l Addtttv e Mfre . Earnin g < $100 M Pe r Yea r $50Mlfflo n _ - "

*-•-• - • ' ' u 1 0 2030405060708 0

Cumulativ

e Percen t o

f 31 4 Companie s < $10 0 M M 9 0 10

0P.2 5 OTHERSPECIA L PROVISION S
• Relabele dadditive s

- Repackage dversion s of othe r manufacturers ' product s

- Exemp t fro mal l standar

drequirement s excep t

basi c registratio n

- Account s fo

r about aquarter o f currently registere dadditiv e products .

- About 40 % o f additiv e "manufacturers " hav e relabele dadditive s only

• Aeroso l additive s

- Examples : carbureto r

cleaners , starter

fluid s

- Exemp t fro mstandar dTier 1 andTier

2 requirements ; mus t

d o only ali t search andqualitativ e exposur e analysi s on th e ra

w produc t

- Testing , i

f any , wil l b e tailore dto th e produc t typ e and compositio n andwil l occur

under Tier 3

• Experimenta

l F/FA s ~ exemp t

fro mregistratio n processe s i n genera l

• Provision s allowin g request s fo r modifie dtestin g procedure s to giv e additiona l flexibilit y i n specia

l cases , including :

- Intermittent-us e aftermarke t additive s

- "Distributio n system " additive s (e.g. , biocides )

- Additive s use dto enhanc e performanc e o f exhaus t aftertreatmen

t device s

- Evaporativ e emissio n generatio n approache sP.2 6



## ECONOMIC SP.2 7 PROGRAM COST S
• Total industry-wide cost s fo r Tier s 1 an

d2 projecte dt o b e $6 6 million , sprea dove r firs t 3- 6 years . Projecte dTier 3 cost s migh

t b e $1 0 millio n per

yea r i n subsequen

t years . • Estimate dcos t

fo r Tier s 1 & 2 , per

grou p o r sol o produc t

(Figur e 9 )

- Generally varie s i n th e rang e o f $440K-800K , dependin g on categor y (baseline , nonbaseline , atypical) , availabilit y o f existin g information , andapplicabilit

y o f evaporativ e emissio n requirement s

- Fo r atypica l product s o f

asmal l busines s (unde

r $10M sales) , cos t varie s i n th e rang e of

$110K-270 K

(Figur e 10 )
• Estimate dcos t

pe r manufacture

r (Figur e 11 )

- Depend s on numbe

r an dtype s o f F/FAs , opportunitie s fo

r cost sharing , applicabilit

y o f specia l provision s

- Varie s i n th e rang e o

f $40 0 to ove

r $3. 7 millio n
• Media n cos t = $50 0 • 8 2 percent

hav e cost s les s tha

n $10,00 0 • Les s tha

n 1 % o f companie s hav e cost s greater tha n $ 1 millio n
• Smal l busines s impact s (Figure s 1 2 and13 )

- Wit h specia l provisions , smal l busines s cost s ar e generally les s tha

n larg e businesse s

- Nevertheless , RF

A project s 1 2 ver

y smal l companie s wit

h atypica l F/FA s coul dfac e closure a s aresul t of complianc e cost s (Figur

e 13) .

- Thi s resul t

ignore s companies ' likely strategi c response s in term s o f produc t pricing , produc t

mix , an dformulation .Figur e 9 . Estimate dComplianc e Cost s Pe r Group *

1
Tie r 1 : Literatur e Searc h Acquisitio n Mileag e Accumulatio n Combustio n Gen./Charac t Evaporativ e Gen./Charac t • Tie r 2 : Combustio n Generatio n S M Samplin g Evaporativ e Generatio n Biologica l Testin g Administrativ e Cost s TOTA L (Rounded) : Gasolin e Fue l Famil y Baselin e $21,00 0 30,00 0 6,40 0 25,85 0 6,27 5
71,50 0 50 0 58,50 0 550,800* * 26,33 5 $797,00 0 Non-Baselin e

$7,00 0 30,00 0 6,40 0 35,75 0 6,77 5
71,50 0 50 0 58,50 0 550,800* * 26,33 5 $794,00 0 Atypica l $7,00 0 30,00 0 48,00 0 58,55 0 0
71,50 0 50 0 0 280,10 0 26,33 5 $522,00 0 Diese l Fue l Famil y

Baselin e $21,00 0 37,20 0 27,50 0 13,00 0 N/ A
58,50 0 0 N/ A 260,60 0 26,33 5 $444,00 0 Non-Baselin e $7,00 0 37,20 0 27,50 0 34,70 0 N/ A
58,50 0 80 0 N/ A 280,10 0 26,33 5 $472,00 0 Atypica l $7,00 0 18,60 0 191,40 0 45,40 0 N/ A
58,50 0 80 0 N/ A 280,10 0 26,33 5 $628,00 0 *Cost s i n thi s tabl e ar e applicabl e t o manufacturer s no tqualifyin g fo r specia l provisions . ••Conducte d o n bot h combustio n an d evaporativ e emissions .P.2 9

Figur e 10 . Estimate d Complianc e Cost s fo r

Small * Atypica l Manufacturer s

Tie r 1 : Literatur e Searc h Acquisitio n Mileag e Accumulatio n Combustio n Gen./Char . Evaporativ e Gen./Char . Tie r 2 Administrativ e Cost s TOTAL (Rounded) : Gasolin e Fue l Famil y $7,00 0 15,00 0 24,00 0 58,55 0 0 Exemp t 9,45 0 $114,00 0 Diese l

Fue l Famil y $7,00 0 18,60 0 191,40 0 45,40 0 N/ A Exemp t 9,45 0 $272,00 0 *Thos e manufacturer s wit h sale s unde r $1 0 million .P.3 0 Figur e 11 : Distributio n o f Complianc e Cost s fo r140 3 Fue l an d Additiv e Manufacturer s Combine d (Includin g Relabeiers ) ' llWl_M__M__B__WBWMim____8 8 80 0

60 0 - 

# i 2

_ 40 0

20 0 -

$0-49 0 $500-1 K$1-5 K $S-10 K$10-50 K$50-100 K$100-500 K$500K-1 M $ 1 - 4 M Cost to Manufacturer sP.3 1
Figur e 12 . Summar y o f Complianc e Cost

s per Manufacture r Typ e o f Manufacture r Minimu m Additive Manufacturers Smal l Larg e Total Fuel Manufacturers Smal l Larg e Total $40 0 $40 0 $40 0 $40 0 $40 0 $40 0 Media n

$50 0 $5,02 9 $91 5 $50 0 $10,98 8 $50 0 Maximu m

$1,207,89 1 $3,717,29 6 $3,717,29 6 $500,90 0 $1,672,70 0 $1,672,70 0 % wit

h cost s > $10,00 0 25 % 43 % 31 % 3 % 53 % 16 %Figur e 13 . Summar y Profil e o

f Manufacturer s Potentiall y Pushe d into Closure P.3 2

Manufacturer' s Produc t

Mix * Tota l 1 1 6 1 4 4 1 3 3 7 1 8 3 Atypica

l Baseline 1 0 1 0 4 2 1 0 4 0 4 0 1 0 - 2 1 2 1 2 5 3 15 1 2 AVERAGE 4. 3 2 2. 2 #o f Employee s 6

1 4 4 4 3 2 4 4 0 4 2 3 Annua

l Sale s $110,00 0 $166,09 6 $260,00 0 $240,00 0 $310,00 0 $340,00 0 $85,00 0 $430,00 0 $300,00 0 $340,00 0 $410,00 0 $280,00 0 $272,59 3 Complianc e

Cos t $272,40 0 $272,40 0 $500,90 0 $272,40 0 $386,70 1 $386,70 1 $114,40 0 $272,60 0 $228,60 0 $229,00 0 $230,10 0 $114,60 0 $273,40 0 RO

A 4.21 % 4.29 % 2.58 % 4.35 % 4.40 % 4.41 % 4.17 % 4.46 % 4.39 % 4.41 % 4.45 % 4.38 % 4.21 % Adjuste d

RO A -310.00 % -194.75 % -227.84 % -128.03 % -137.13 % -123.34 % -171.42 % -64.97 % -82.37 % -71.24 % -57.33 % -42.57 % -134.25 % •Th e firstcohim n indicate s tota l numbe r o f products , th e secon d cohim n i s numbe r o f atypica l products , an d th e third cohim n i s numbe r o f baselin e products .P.3 3 *• SUMMAR Y Workgroup closur

e o n final rul e i s schedule dfo r Ma y 10 , 1994 Forma l rulemakin g packag e wil l b e delivere dto OM B shortly thereafter , including :

- Preambl e

- Regulation s

- Regulator

y Suppor t Document/Regulator

y Flexibilit

y Analysi s

- Informatio n Collectio n Reques t

- Reques t fo r OM B Review (SF83 )

- Federalis mReview Shoul db e ver

y simila r to draft s provide dpreviousl y Timetable : Fina

l rul e mustb e signe d o n Ma y 27t h