P. 1 

# OAR Box 

# 1846 Prepped by Ollie Stewart

Document

Number: 

# 52 ) ll-F- 6 Docket Number: 

# A-90-0 7

Printed 11/18/20087:30:16

AM Sheet 52 of 93P. 2 

### A-90-o 7 ZUL-t- otp 

## NOTIC E O F PROPOSE

D RULEMAKING : FUEL S AN

D FUE L ADDITIVES REGISTRATIO

N PROGRA

M ULi I JU . S;.A ; Uj [ EPAAIRDQCKF T 

## Briefin g fo r the Offic e o f Managemen

tan d Budge t November 22 , 199 1

Emissio n Control Technolog y Divisio n Offic e o f Mobile Source s Offic e of Air an d Radiatio n 

### U.S . Environmenta

l Protectio n Agenc

y 

# mP. 3



# BACKGROUN DP. 4 

### HISTOR Y 197 0 Congres s enact

s CA A section s 211(a)-(d) . 197 5 EP A implements basi c F/F A registration progra

m unde r section s 211(a ) an d 211(b)(1) , bu

tdoe s no timplementF/F

A testin g progra

m authorized by sectio n 211(b)(2) . 197 7 Congres s enacts sectio n 211(e) , making implementatio n o f 211(b)(2 ) mandator

y withi n one year . 197 8 ANPR

M published . Bu

tn o proposa

l o r fina l rul e follows . 198 9 Citizen s grou

p sue s EP

A for failur

e t o promulgat

e 211(b)(2) . EP

A enter s int o consen tdecre e settin g th e followin g schedule : • ANPR M due Augus t1 , 199 0 • NPR M due Januar

y 1 , 199 2 • Fina l rule due Jun

e 1 , 1993 199 0 ANPR

M publishe d (5 5 F

R32218 , Augus t7 , 1990) . 199 1 EP A engage s consultantt

o investigate feasibilit

y of usin g Reg Ne g for th e F/FA progra

m rulemaking , bu

tfinds insufficien tinterest among, ke y parties . (February-May , 1991 ) NPR M developmen tan

d workgrou

p closure .P. 5



## PROGRA M SCOP EP. 6 GENERA L FOCU S Majo r focu s i s o n determinatio n o f potentia l advers e healt

h effects

- Use s tiere d evaluatio n approach , emphasizin g literatur e researc h an

d short-ter mtestin g method s wit

h allowanc e fo

r mor e rigorous studie s a s require d

- Recognize s adequat

e existin g datai

n lie u o f duplicativ e testin g

- Provide s fo

r voluntar y groupin g an

dcos t sharin g b

y producer s o

f simila r F/FAs , t o furthe r minimiz e complianc e burden s
• Addresse s effect s o

f F/F A emission s only , not

"raw " (liquid ) F/FA s

- Consistent

wit h genera l objective s o

f Clea n Ai r Act a s awhole , legislativ e intent

o f Sectio n 211 , an

d scop e o f regulator y authorit y unde r 211(c )

- Include s bot

h combustio n an

devaporativ e emission s

- Applicabilit

y o f evaporativ e emissio n requirement s depend s o n F/F A volatilit y Addresse s atmospheri c transformatio n product s onl y throug h analyti c methods . Fo r

now , actua

l la b testin g requirement s preclude d b y scientifi c and technica

l limitations .P. 7

SCOP E OF HEALT H EFFECT S PROVISION S Focu s • Potentia l advers e effects o

f inhalatio n exposur

e t o F/F A emission s Endpoint s • Require d by statute : carcinogenicity , mutagenicity , teratogenicit y • Additiona

l endpoint s proposed : adul t reproductive , pulmonary , an d neurologi c effect s Approac h (se e Figur e 1 ) • Component s o

f evaluatio n organize dwithi n thre e successiv e tiers : Tier 1 : Emissio n characterization , literatur e search , an d modelin g Tier 2 : Short-ter

mbiologica

l testin g Tier 3 : Additiona

l testing , i

f any , following EPA' s review o f submittal ; tailore dto need s identifie d in Tier s 1 and 2 • Requirement s o

f Tier s 1 an

d2 ca n b e satisfie dby adequat e existin g informatio n

- "Adequacy " depend s o

n exposur e scenario , dosages , and duration , technica l an d statistica

l methods , completenes s o f documentation , age o f data , e t al . • Three-yea

r complianc e tim

e (o r pre-registratio n requirement) pertain s only to Tier s 1 and 2P. 8 Figur e 1 : Overvie w of

Evaluatio n Tiers START

-L Tier l ° Characterizatio n o

f emission s o Summar

y of previou s healt

h and environmental studie s ° Analyse s of

atmospheri c reactivity , exposur e potential , an

d environmental partitionin g Inadequat e existin g informatio n Tie r I Short-ter m tests for carcinogenic , mutagenic , teratogenic , reproductive , pulmonary , and neurologi c effect s EP A evaluatio n o

f Tie r 1 & 2 dat

a an d decisio n o n nee d for additional testin g

Additional testin g neede d Additional test s (e.g . lon g ter m anima l exposure s and/o r furthe r emissio n characterization ) prescribe d on a case-by-cas e basis , t

o clarify , verify , o r quantif y th e results of

Tier s 1 & 2 . EN D Adequat e existin g informatio n

Additiona l testin g notneede d

* "Adequate " implie s thatth e existin g informatio n include s th e results o f properly performe d and well-documente d studie s comparabl e t o th e tests require d i n Tie r 2 .P. 9

SCOP E OF WELFAR

E EFFECT S PROVISION S Background • Sectio n 211(b ) specifie s onl y tha t "reasonabl e an

d necessary " informatio n b e furnishedo n the welfar

e effects o

f F/F A emission s • Specifi c welfar

e effect s endpoint s not

stipulate d an

d testin g no t

require d b y the statut

e • Scientifi c experienc e an

d screenin g method s fo

r welfar e effects ar

e mor e limite d tha

n fo r healt h effects • Othe r EP A program s focu s o

n contributio n o

f F/F A emission s to majo

r environmenta

l problem s such as aci drain , globa l warming , an

d ozon e effects Proposed Approac

h • Addres s welfar

e effects throug h literatur e researc h an

d modelin g method s rather

tha n laborator

y testin g • Thes e requirement s conducte di n conjunctio n wit

h Tier 1 o f healt h effect s evaluatio n • Comment s ar

e requeste d o

n possibilit

y o f includin g welfar

e effects testin g i n Tier

3 whe n Tier 1 demonstrate s significan t environmenta

l toxicit y potentialP.1 0

SCOP E OF EMISSIO N CONTRO L SYSTE M PROVISION S Background • Sectio n 211(b ) authorize s testin g to determin e F/F A impac t o n th e abilit y o f EC S equipmen

t t o compl y wit h emissio n standard s • Significan

t overla p wit h Sectio n 211(f

) rule s firs t

implemente d i

n 197 7

- Establishe s criteri afo

r F/FA s considere d "substantially similar " t o certificatio n fuel s

- For F/FA s tha

t ar e not "sub-sim" , require s EC S testin g t o obtai n a waive r allowin g introductio n int

o commerc e • Applicabilit

y o f Sectio n 211(f

)

- I n the past , applie d only t

o unleade dgasolin e andit s bul k additive s

- 199 0 CA

A Amendment s extende d211(f ) authorit y to othe r F/F A types , e.g. , diese l an

d "alternative " fuels . "Su b sim " rule s fo

r thes e fuel s ar e planned .

- Unde r "grandfathering " provision , stil l doe s no t appl y t o non-gasolin e F/FA s and aftermarke

t gasolin e additive s introduce d pre-199 0 Proposed Approach • Continu e 211(f

) jurisdictio n fo

r EC S testin g • T o addres s concern s abou t grandfathere d F/FAs , EP

A ma y (a t it s discre tion ) requir

e waive r appUcation fo

r particula r F/FA s upon petitio n o

f vehicl e manufacturer s o

r othe r intereste dpartie sP.1 1

PROVISION S REDUCIN G COMPLIANCE BURDE N Addresse s emission s effects onl y Recognize s existin g informatio n Exempt s "relabeled " product s Limit s applicabilit

y o f evaporativ e emissio n testin g Limit s routin e healt

h effects testin g to short-ter mstudie s Provide s fo

r grou p testing , information submittal , an dcos t sharin g Limit s welfar

e effects provision s t

o analyti c method s Integrate s emissio n contro l syste mprovision s wit

h existin g waive

r progra m Othe r possibl e provisions/exemption s presente d fo r publi c comment :

- Possibl e exemption s fo r "d e minimis " factor s such a s "sub-sim " additive s use d i

n ver y smal l amount s o

r "non-sub-sim " additive s wit h negligibl e concentration s o f element s o

f concer n

- Possibl e temporar

y exemption s fo

r experimenta

l F/FA s used fo

r research , development , an devaluation , an

dnot ye t i n commercia

l distributio n or

wholesale/retai l sale .P.1 2



## GROUPIN G SYSTE

MP.1 3 GROUPIN G SYSTE

M OVERVIEW Objective s • Enabl e manufacturer s o f chemically simila

r products , on avoluntar

y basis , t o shar e cost s o f progra mcomplianc e • Minimiz e duplicativ e efforts an dredundan

t informatio n • Eas e deman d o

n limite dlaborator

y capacit y • Decreas e volume o

f materia l fo r EP A review an

d analysi s Genera l Principle s • Group s ar

e definedbase do

n compositio n o

f "raw " F/FAs , sinc e compositio n o

f emission s not

yet know n • Fuel s an

d relate d fue

l additive s ar

e groupe dtogethe

r • Additive s ar

e sorte d accordin g to the characteristic s o f the associate din us e additive/fue l mixtur

e • Producer s o

f F/FA s i n the sam

e grou p ca n conduc t

cooperativ e evaluatio n and testin g usin g arepresentativ e produc t selecte d accordin g to EP A rule s • Tes t result s fo r representative s wil l b e applie d to al l grou p member sP.1 4 FRAMEWOR

K Each F/F A i s firs t sorte dinto aFuel/Additiv e Categor y defined b

y the applicabl e "fue

l family " an

d "formulation class. " (se e Figure s 2 - 4 )

• Fue l familie s reflec t

basi c chemical/physica

l propertie s and engin e usage , e.g. , unleade d gasoline an d diese l familie s

- A "bas e fuel" , representin g the industr y average , i s to b e defined fo r each famil

y Formulatio n classe s reflect th e degre e o

f similarit y to th e bas e fue

l i n each famil y

- Baseline : F/FA s limite d as t o permissibl e element s and , i n som e cases , a s to the amount s o f such elements . (Variou s alternativ e criteri aar e presente dfo

r comment )

- Non-baseline : Contai n sam e element s a s permitte d i

n Baseline , but excee d concentratio n limit s

- Atypical : Contai n element s not include d i

n Baselin e Each categor

y ma y b e furthe

r subdivide dint

o on e or mor e F/F A group(s) , dependin g on th e variabilit y o f F/FA s withi n th e categor y (variou s alternative s propose d fo

r comment ) Withi n eac h group , either

the bas e fue

l or amembe r F/F A i s specifie dto represen t th e group i

n testin gFigur e 2 : Fue l / Additiv e Classificatio n Hierarch y Conventiona l Unleade d Gasolin e Leade d Gasolin e Diese l Alternativ e Methano l Ethano l Methan e (CNG , LNG ) Propan e (LPG ) —Fue l Familie s X . Formulatio n Classe s Baselin e Non-Iluselin e Atypica l Fuel / Additiv e Categorie s Fue l / Additiv e Testin g Group s Grou p Representative sFIGUR E 3 : FUEUADDITIV E CATEGORIE S

FORMULATIO N CLASSE S (1 ) BASEUN E FORMULATION S

(2 ) NO N BASEUN E FORMULATION S

(3 ) ATYPICA L FORMULATION S •CONVENTIONAL " FUE L FAMILIE S UNLEADE D GASOUN E

(A ) BASELIN E UNLEADE D GASOUN E CATEGOR Y ON E GROU P REPRESENTE D B Y UNLEADE D BAS E FUE L
NONBASELIN E UNLEADE D GASOUN E CATEGOR Y GROUPE D ACCORDIN G T O PRESENC E O F NONBASELIN E FACTOR S ATYPICA L UNLEADE D GASOLIN E CATEGOR Y GROUPE D ACCORDIN G T O ATYPICA L ELEMENT S AN D OTHE R CHARACTERISTIC S LEADE D GASOLIN E 18 ) BASELIN E LEADE D GASOLIN E CATEGOR Y ON E GROU P REPRESENTE D B Y LEADE D BAS E FUE L NONBASELIN E LEADE D GASOLIN E CATEGOR Y GROUPE D ACCORDIN G T O PRESENC E O F NON-BASEUN E FACTOR S ATYPICA L LEADE D GASOUN E CATEGOR Y GROUPE D ACCORDIN G T O ATYPICA L ELEMENT S AN D OTHE R CHARACTERISTIC S DIESE L (C ) BASEUN E DIESE L CATEGOR Y ON E GROU P REPRESENTE D B Y DIESE L BAS E FUE L
NO N BASEUN E DIESE L CATEGOR Y GROUPE D ACCORDIN G T O PRESENC E O F NON-BASEUN E FACTOR S ATYPICA L OIESE L CATEGOR Y GROUPE D ACCORDIN G T O ATYPICA L ELEMENT S AN D OTHE R CHARACTERISTIC S •ALTERNATIVE " FUE L FAMILIE S METHANO L (>-50 % MeO H BY VOL )

(0 ) BASEUN E METHANO L CATEGOR Y TW O GROUP S (M96M10 0 AN D M50-M95 ) REPRESENTE D B

Y M l 0 0 AN D MB S BAS E FUEL S NONBASELIN E METHANO L CATEGOR Y GROUP S TB A
ATYPICA L METHANO L CATEGOR Y GROUP S TB A ETHANO L

( > = 50y . EtO H B Y VOL )

(E ) BASEUN E ETHANO L CATEGOR Y TW O GROUP S (E9^E10 O AN D E5 0 E95 ) REPRESENTE D B Y ElO O AN D E8 5 BAS E FUEL S NONBASELIN E ETHANO L CATEGOR Y GROUP S TB A
ATYPICA L ETHANO L CATEGOR Y GROUP S TB A METHAN E (CNG . LNG ) (F ) BASE1IN E METHAN E CATEGOR Y TW O GROUP S (CN G AN D LNG ) REPRESENTATE D B Y CN G AN D LN G BAS E FUEL S NO N BASELIN E METHAN E CATEGOR Y GROUP S TB A
ATYPICA L METHAN E CATEGOR Y GROUP S TB A PROPAN E (LPG ) (G ) BASEUN E PROPAN E CATEGOR Y ON E GROU P REPRESENTE D U Y LP G BAS E FUE l
NO N BASELIN E PROPAN E CATEGOR Y GROUP S TB A
ATYPICA L PROPAN E CATEGOR Y GROUP S TB A

' EAC H CATEGOR Y CONTAIN S ON E O R MOR E FUEUADDITIV E GROUPS . HEALT H EFFECT S TESTIN G INFORMATIO N I S REQUIRE D FO R EAC H SUC H FUEL/ADDITIV E GROU PP-17 .

Figure 4 : Groups , Manufacturers , an d Product s i n Selecte d Fuel/Additive Categorie s Formulatio n Clas s Baselin e Formulation s Non-Baselin e Formulation s Atypica l Formulation s Fue l Famil y

Unleade d Gasolin e 1 Grou p 52 7 Manufacturer

s 153 0 Product s 1 7 Group s 645 Manufacturer

s 97 6 Product s 48 Group s 137 Manufacturer

s 19 7 Product s Diese l 1 Grou p 30 5 Manufacturer

s 76 9 Product s 1 Grou p 2 Manufacturer

s 2 Product s 4 7 Group s 148 Manufacturers 22 3 Product sP.1 8 IMPLEMENTATIO N ISSUE S Organizatio n of

F/F A Group s • Producer s expecte d t

o determin e appropriat

e group s fo

r their F/FA s • Enrollmen

t an dadministratio n o

f group s t o b e brokere d by industr

y • Third-part

y mechanism s ma

y b e usefu

l to reduc e potentia

l problem s regardin g confidentia

l busines s informatio n Cost-sharin g Provision s • Initia l proposa l leave s developmen

t o f thes e provision s u

p to the participants . Need s to accoun t for :

- Prospectiv e cost-sharin g arrangement s

- Reimbursemen

t arrangement s • Alternativ e EPA-administere d mechanism s ar e presente d fo

r commen tP.1 9



# EVALUATIO

N O F HEALTH/WELFAR

E EFFECTSP.2 0 EMISSIO N GENERATIO N Controlle d generatio n an

dsamplin g o

f emission s for :

- Emissio n characterization : brie f collectio n period , storage , an d us e

- Biologica

l testing : continuou s generatio n an d routin g o

f dilute d emission s to testin g chamber s
• Proposa l seek s balanc e between desir e fo r certaint y an dpractical constraints , regardin g numbe r o f vehicles , ne

w vs . used vehicles , an

d mileag e requirement s

- Basi c proposal : on

e ne w vehicle , minimumo

f 25,00 0 accumulate d mile s prio r

to emissio n generation , fo r each subjec t

F/F A

- Alternativ e proposal : 6 vehicles , ne w o r used , minimumo

f 4,00 0 accumulate d miles . Multipl e F/FA s ca n us e sam

e vehicles , wit

h preconditionin g cycl e i

n between . Al l vehicle s use d fo r emissio n characterization , wit

h on e selecte dfo

r biologica l testing . For F/FA s wit

h atypica l elements , mileag e accumulatio n mus t continu e unti l emission s "stead

y state " o r

80 % o f vehicl e useful lif

e i s reache d
• Combustio n emissio n generatio n involve s repeate d FTP s Evaporativ e emissio n generatio n use s FTP-SHED metho dfo r emissio n characterization , evaporativ e chambe r fo r biologica l testin gP.2 1 TIER1 : EMISSIO N SPECIATIO N Function s • Satisfie s statutor

y provisio n to "determine th e emissions " o

f F/FA s • Provide s inventor

y o f potentiall y hazardou s motor vehicl e emissions , an

d provide s basi s fo

r analytica l an d modelin g studie s Requirement

s (se e Figure 5 ) • Focu s o

n measuremen

t o f regulate d emission s an

d o n detectio n an

d measuremen

t o f selecte dchemica

l classe s and compound s o f interes t • Dependin g on F/F

A an d emissio n type , includes :

- Tota l hydrocarbons , NOx , CO , an d particulate

- Speciatio n o

f hydrocarbons , ketone s an daldehydes , alcohol s an d ethers , PAH an

dNPA H • F/FA s wit

h atypica l element s mus t

b e analyze d fo

r the emission s fat

e o f the element s o

f concer nP.2 2



### Figur e 5 : Emissio n Characterizatio n Requirements
Emissio n Typ e R E H C Ke t Al e PA H NPA H & & Ai d Et h Combustio n Emission s Vapo rphas e emission s Semi-volatil e phas e emission s Particulat e phas e emission s X X * X X X X Evaporativ e Emission s * * Diurna l emission s Ho t soa k emission s X X X X X *

X *

* Require d i f alcohol s o rether s exis t i n th e uncombuste d fue l * * Onl y applicabl e t o fuels/additive s require d t o measur e evaporativ e emission s RE=regulate d emissions , HC=hydrocarbons , Ai d & Ket=aldehyde s an d ketone s Al e & Eth=alcohol s an d ethers , PAH=polycycli c aromati c hydrocarbons , NPAH=nitrate d polycycli c aromati c hydrocarbon sP.2 3

TIER1 : DAT

A RESEARC H AN

D ANALYSI S Literature Search • Function s

- Furnis h EP

A wit h comprehensiv e summar

y o f existin g informatio n o

n composition/toxicit

y o f F/F A emission s

- Documen

t th e extent

to which existin g dat aca n satisf y emissio n characterizatio n an

d Tier 2 requirement s • Requirement s

- Searc h o

f pubhshe dan

din-hous e source s o

f informatio n o n effect s o

f whol e and speciate d emission s

- Searc h o

f toxicologi c andenvironmenta l dat abase s

- Ma y include epidemiologic , clinical , animal-based , and field studie s Modeling Approache s • Estimat e ambient exposure s to F/F

A emission s • Project atmospheri c transformatio n product s usin g model s and/or theoretica l chemica l analysi s • Evaluat e potential environmenta

l partitionin g of

emission s to air , soil , water , an d biot aTIE R2 REQUIREMENT S

I n general , include s short-ter m(42-day ) inhalatio n exposure s o f animal s to F/F A emission s a

t thre e dilutions , t

o screen fo

r the following effects : Carcinogenicit

y an d Mutagenicit

y • Ame s Revers e Mutatio n Assa y • In Vivo Micronucleu s Assa y • In Vivo Sister

Chromati dExchang e Developmenta

l Toxicit y (Teratogenicity ) • Exposur

e o f animal s durin g sensitiv e perio do f pregnanc y wit

h subsequent

analysi s o

f effects on fetu s Reproduction/Fertilit

y Effect s • Exposur

e o f adul t male s an d female s befor

e an d afte r mating , wit

h analysi s o f effect s on adult

reproductiv e structure s and numbe r an d viabilit y o f offspring Pulmonar y Toxicit y • Examinatio n o

f lung tissues , cells , an

dbiochemistr

y following inhalatio n exposur

e Neurotoxicit

y • Functiona

l observationa

l batter y o n liv e animal s throughout exposur e perio dP.2 5 TIER3 REQUIREMENT S Criteri a fo r Escalatio n t

o Tie r 3
• Based o n identificatio n o

f importan t informatio n gap s o

r uncertaintie s i

n toxicit y data , wit

h qualitativ e consideratio n o f exposur e potentia l
• Genera l decisio n criteri ainclude :

- Numbe r o f positiv e an

dnegativ e outcome s fo

r each endpoin

t

- Identificatio n o

f concentration-effec t

relationship s

- Statistical sensitivit

y an d significanc e o

f studie s

- Severit y o f observe deffect s

- Numbe r o f specie s involve d i

n reporte d test s

- Consistenc y an

dclarit y o f apparen t mechanisms , target

organs , an

d outcome s

- Natur e and amoun

t o f know n toxi c agent s in the emission s strea m Tie r 3 Testin g
• Requirement s determine d o n case-by-cas e basi s to addres s specifi c area s o f uncertaint

y identifie d in Tier

1 and/or Tier 2 • Ma y include furthe

r emissio n characterization , longer-ter mbiologica

l testing , and/o r

exposur e studie sP.2 6

RELATIONSHIP S WITH REFORMULATE D GASOLIN

E (RFG ) • RF G Progra mi s akey regulator

y chang e i n the motor

vehicl e fuel s are a

- Much wor

k done i n developmen

t o f thi s mandator

y progra m

- Usefu l to lear n fro mtha t experienc e an d to b e compatibl e an d complementar

y whe n possible , sinc e F/F

A progra mapplie s to RFG s • Timin g factors :

- Phas e 1 RFG : 199 5

- F/F A Rule : 199 6

- Phas e 2 RFG : 1997
• Tw o majo

r area s fo r consideration : 1 . Emissio n Generation/Characterizatio n

- F/F A an dRF G program s designe d fo

r differen t purpose s an

d giv e differen t result s

- Simila r vehicl e selection , sample size , and mileag e accumulatio n

- Simila r analyti c requirement s

- Compatibl e dataca

n b e used 2 . Grouping s

- RF G subject to testin g unde

r F/F A progra m

- Scope.o f

F/F A progra mfo r Phas e 1 RF

G depend s o

n groupin g schem e

- Base d o n groupin g considerations , Phas e 2 RF G wil l probably no t hav e t o retes t

unles s new compound s ar e adde dP.2 7



## ECONOMIC SP.2 8 PROGRAM COST S Estimate d industry-wide cost s fo r Tier s 1 an

d 2 woul d approximat

e $8 3 millio n ove

r the firs t thre e year s afte

r th e fina l rule , i.e. , about

$2 7 million/yea

r Estimate d cos t

pe r manufacture

r (se e Figur

e 6 )

- Depend s on numbe

r an d type s o f F/FA s and opportunitie s fo r cost sharin g

- Migh t var y fro m$50 0 to ove

r $ 2 million , wit

h media n cos t of . about $200 0
• Estimate dcos t

per individua l produc t

- Depend s o n typ e o

f product , availabilit

y o f existin g information , an

d applicabilit

y o f evaporativ e emissio n requirement s

- Fo r asol o atypica

l additiv e which i s subject to evaporativ e emissio n requirement s andha s n o existin g informatio n (wors t case) , estimate d cost s total about

$1. 3 million : Tier 1 $ 114,75 0 Tier 2 993,38 0 Administratio n 156.900 Tota l $ 1,265,03 0 Projecte d Tier

3 cost s migh

t b e $1 0 millio n per

yea r i n subsequen

t thre e year sC O

C D O C O cr j 80 0 70 0 60 0 50 0 40 0 O l _30 0 C D - Q £ 20 0 10 0 

## Figur e 6 : Distributio n o f Complianc e Cost s fo rFue l an d Additiv e Manufacturer s Combine d

15 0 66 7 i



### [fill

9

fBuwwuguuHi 10 9

'&&*',& J ! 3

7 8 0 4 2

liMil l 1 4 WnttMii Ka&gSasag

a 100-50 0 1K-5 K 10K-50 K 100K-500 K 1M-1.5 M 500-100 0 5K-10 K 50K-100 K 500K-1 M 1.5M + 

## Cos t t o Manufacture r(dollars )P.3 0 SMALL BUSINES S PROVISION S Authorit y • Unde r Sectio n 21 1 (e)(3) , EP

A ma v modif y the F/F A registratio n require ment s fo r smal l businesse s • "Small business " i s to b e definedwithi n the regulation s Initial Proposa

l • No specia

l allowance s fo

r small businesse s i

n consideratio n o

f costreductio n provision s fo

r all manufacturer s • Difficul t to define "smal l business " on factor s other tha n financia l statu s Impacto n Small Busineses s (as defined b v SBA ) • O n average , smal l companie s hav e lowe r complianc e cost s tha

n larg e ones , but ar e mor e vulnerabl e to cos t

burden s • Cost s fo

r 85 % o f smal l fue

l companie s an

d80 % o f smal l additiv e companie s estimate d a

t les s tha n $10,00 0 • No significant

impac t on small fue

l companies , bu

t 2 3 (6% ) o

f smal l additiv e manufacturer s migh t experienc e financia

l distres s an

d 2 migh t b e pushe dinto closure (ROA < -30%) . Possibl e Provision s • Further analysi s planne d to identif y specifi c vulnerabilitie s • Partial mitigatio n o

f requirement s ma

y b e considere dP.3 1 SUMMAR Y NPR M packag e comin g to OM B shortly include s th

e following :

- Preamble
- Regulation s
- Regulator

y Suppor tDocument
- Regulator

y Flexibility Analysi s
- Information Collectio n Reques t
- Communicatio n Strateg y
- Reques tfo r OM

B Revie w (SF83 )

- Federalis m Revie w Timetabl e

- Pe r consen tdecree , deadlin e for proposa l i s Januar

y 1 , 199 2