P.1 

OAR Box 1834 

Prepped by Keeia Richards 

Document Number: 

54) IV-H-08 

Docket Number: 

A-90-07 

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

J5T-//-08 

5. is f JJUUL 

H 

FINAL RULE: 

FUELS AND FUEL ADDITIVES 

REGISTRATION PROGRAM 

uu MAY 2 £» J»M \3\ 

EPA AIR DOCKET 

Briefing for the 

Office of Management and Budget 

May 3, 1994 

Regulation Development and Support Division 

Office of Mobile Sources 

Office of Air and Radiation 

U.S. Environmental Protection Agency 

m 
P.3 

r 

OVERVIEW 

Background 

• Review of Statutory Provisions 

• Rulemaking History 

Program Scope 

• Applicability 

• Program Focus 

• Scope of Requirements 

• Timing of Requirements 

Special Provisions 

• Grouping System 

• Alternative Tier 2 Provision 

• Small Business Provisions 

• Other Special Provisions 

Economics ___. 

• Program Costs 

Summary 
P.4 

BACKGROUND 
P.5 

STATUTORY PROVISIONS 

Clean Air Act Sections 211 (a) and (b) - 1970 

• Authorize EPA to designate types of fuels or fuel additives (F/FAs), and 

to require designated F/FA products to be registered by their 

manufacturers as a condition for their sale or commerce 

• Grant EPA discretionary authority to require producers to conduct tests 

and submit information on: 

- Composition of F/FA emissions 

- Effects of F/FA emissions on designated health parameters 

- Impact of F/FA emissions on the public welfare 

- Effects of F/FAs on emission control system performance 

• Any regulatory control based on such information requires follow-on 

rulemaking under Section 211(c) 

Clean Air Act Section 211(e) • 1977 

• Makes implementation of the testing requirements mandatory and sets 

compliance deadlines for the "requisite data": 

- For already registered F/FAs: three years from final rulemaking 

- For new products: prior to registration 

• Authorizes_ special provisions for: 

- Small businesses 

- Cost-sharing arrangements 

- Avoidance of duplicative information 
P.6 

RULEMAKING HISTORY 

1970 Congress enacts CAA sections 211(a)-(d). 

1975 EPA implements basic F/FA registration program under sections 

211(a) and 211(b)(1), but does not implement F/FA testing program 

authorized by section 211(b)(2). 

1977 Congress enacts section 211(e), making implementation of 

211(b)(2) mandatory within one year. 

1978 ANPRM published. But no proposal or final rule follows. 

1989 Citizens group sues EPA for failure to promulgate 211(e). EPA 

enters into consent decree setting a rulemaking schedule 

1990 ANPRM published (55 FR 32218, August 7, 1990). 

1991 EPA engages consultant to investigate feasibility of using Reg Neg 

for the F/FA program rulemaking, but finds insufficient interest 

among key parties. (February-May, 1991) 

1992 NPRM published (57 FR 13168, April 15, 199$ 

1994 Notice to Reopen Comment Period (59 FR 8886, Feb. 24, 1994) 

Final Deadline for Promulgation: May 27,1994 
P.7 

PROGRAM SCOPE 
P.8 

APPLICABILITY 

All F/FAs designated for registration are subject to the testing program 

- Compliance required for existing F/FAs to retain registrations. 

(To date, about 2,000 producers have registered over 7,200 fuel 

and additive products.) 

- Compliance also required for new F/FAs to become registered 

Currently, only gasoline and diesel F/FAs are designated 

- Testing program omits leaded gasoline products, due to upcoming ban 

underCAA§211(n) 

- Off-road F/FAs excluded at this time 

• Designation of other "alternative" F/FA families is planned, i.e., 

methanol, ethanol, CNG, LPG 

- Provision will be made to ensure their market access will not be 

interrupted during phase-in period 

A number of special provisions (discussed later) impact the applicability 

of various requirements to particular F/FAs or types of F/FAs 
P.9 

PROGRAM FOCUS 

• Basic tenets and structure of the program are consistent with the NPRM 

• Major focus: 

- Determination of potential adverse health effects of F/FA exhaust and 

evaporative emissions 

- Main thrust is evaluation of effects of inhalation exposure to the 

whole complex emission mixtures generated by F/FAs in use, not 

toxicology of individual pure compounds 

• Underlying principles: 

- Uses tiered evaluation approach, emphasizing short-term testing with 

allowance for more rigorous studies as required 

- Recognizes adequate existing data, if available, in lieu of requiring 

duplicative testing. "Adequacy" depends on documented exposure 

scenarios, technical procedures, statistical methods, et al. 

- Provides for voluntary grouping and cost sharing by producers of 

similar F/FAs, to further reduce duplication and costs 

- Small business allowances and other special provisions also help 

reduce compliance burdens 

• Approach to other statutory requirements: 

- Welfare effects addressed primarily through literature search 

- Emission control system effects addressed primarily through existing 

regulatory mechanisms (e.g., waiver program) 

- On a case-by-case basis, EPA retains the right to require specific 

testing in these areas 
P.10 

SCOPE OF REQUIREMENTS 

Requirements have been streamlined in comparison with NPRM 

- Proposed modeling requirements (quantitative exposure, atmospheric 

reactivity, and environmental partitioning analyses) deleted 

- Proposed series of 42-day biological tests replaced with a single 90-

day protocol. 

- Technical changes to simplify and coordinate specific endpoint tests 

Evaluation Tiers (Figure 1) 

Tier 1: 

- Literature search on health/welfare effects of emissions 

- Qualitative exposure analysis based on F/FA production/use 

- Emission Characterization (Figure 2) 

Tier 2: Short-term toxicology testing 

- In general, entails 90-day (subchronic) inhalation exposures 

- Animals exposed to whole, "real-time" vehicle/engine combustion 

emissions and (when indicated) to evaporative emissions generated 

from a fuel tank or vessel 

- Evaluation of general organ/systemic toxicity, with special endpoint 

assessments (carcinogenicity, mutagenicity, developmental and 

fertility effects, pulmonary and neuro effects) 

- A single exposure scenario feasible for all endpoints (Figure 3) 

Tier 3: Follow-up testing (if needed) on a case-by-case basis, targeted 

to identified areas of concern 
P.11 

Figure 1. Overview of Evaluation Tiers' 

Start 

I 

Basic Registration Data 

J 

Tier 1 

Literature search 

Characterization of emissionsb 

Exposure analysis 

J 

Tier 2 b 

90-day subchronic inhalation study with additional tests for 

carcinogenicity, mutagenicity, teratogenicity, reproductive 

toxicity, and neurotoxicity 

I 

EPA evaluation of Tiers 1 & 2 data 

and determination of need for Tier 3 

Additional 

testing needed 

" 

Tier 3 

• 

Current 

Requirements 

complete ° 

Additional 

testing 

not needed 

a

 This chart shows the general requirements for most F/FAs. Special provisions 

are not depicted. 

Required unless adequate data exist. 

c

 EPA retains the authority to require additional testing if new concerns arise. 
Figure 2. Emission Characterization/Measurement Requirements 

Emission 

Type 

Combustion 

Emissions: 

Vapor Phase 

Semivolatile 

Phase 

Particulate 

Phase 

Evaporative 

Emissions:* 

Evaporative 

Emission 

Generator* 

Basic 

Emissions" 

Speciated Emissions 

Hydrocarbons Ketones 

and 

Aldehydes 

Alcohols 

and 

Ethers" 

Polycyclic 

Aromatic 

Hydrocarbons 

(PAHs)c 

Nitrated 

Polycyclic 

Aromatic 

Hydrocarbons 

(NPAHs)

 c 

Atypicalsd 

X 

X 

X X X 

X 

X 

X 

X 

X 

X 

X 

X' X X X 

a Basic emissions = total hydrocarbons, carbon monoxide, oxides of nitrogen, and particulates (see Section 

VII.B.2.a below) 

bRequired if alcohols or ethers exist in the uncombusted fuel or additive/base fuel mixture. 

c Not required for methane (CNG, LNG) or propane (LPG) . 

d Manufacturers of atypical products must examine all emission fractions for the measurement and 

identification of potential atypical species. 

•Only applicable to F/FAs required to measure evaporative emissions. 

£ Evaporative emissions are to be generated using an evaporative emission generator as described in Section 

VI.C. 

9 The only basic emission required to be measured for evaporative emissions is total hydrocarbons. 
25 9 +25 d* 

1-2__1 

Acclimatization 

And Culling 

Figure 3. Suggested Timing and Organization of Tier 2 Studies 

Exposure Analysis 

t 

__ 

Exposure for Subchronic Study 

(General Toxicity and Other Endpoints) 

5d\-5 ? 

Perfused for 

neuro, testis, 

king histology 

20d"+ 20 ? 

Fixed for 

general 

histology 

JL JL 10 11 12 13 14 

1 

5(^+5 . 

Tissues (or 

GFAP. MN, 

SCE 

25 * Exposure for Fertility/Teratology Studies 

(Exposure 

ends at 

Gestation 

Day 15) 

Estrous Cycle 

Analyses 

Mating Termination. 

(w/ above d") (Gestation Day 20) 

Fetal/Uterine 

Analysis 

20-25 pregnancies 

NOTE: This diagram illustrates testing at one dosage level, using 75 animals. Complete Tier 2 requires testing at four 

dosage levels (high, medium, low, and control), requiring a minimum of 300 animals (4 x 75), plus an additional 

group of 20 animals exposed at the high dose and held 28 days for study of recovery potential. Timing of Salmonella 

mutagenicity assay is independent of this testing scenario. 

I 
P.14 

TIMING OF REQUIREMENTS 

• §211(b) requires emissions characterization and health effects test data, 

and mandates certain health effects endpoints: 

- These mandatory requirements are incorporated in Tiers 1 and 2 

• However, §211(e) says that the "requisite" data must be submitted for 

existing F/FAs within 3 years of promulgation of rule 

- Difficult for all manufacturers to complete Tiers 1 and 2 in 3 years, 

given number of F/FAs (or groups), complexity of testing, current 

shortage of labs, and time for lab capacity to come on line 

• Thus, for existing F/FAs, final rule has the following timing provisions: 

- "Requisite data", due within 3 years, includes Tier 1 plus a contract 

with a qualified lab to complete Tier 2. 

- All Tier 2 results are due within 3 additional years. Failure to meet 

this deadline risks financial penalties and/or loss of registration 

- Note: April 22nd draft rule does not contain this provision 

• For F/FAs not registered, final rule distinguishes two types (see Fig 4): 

"Registrable" products = F/FAs which fit criteria for grouping with 

currently registered fuels and bulk additives in same fuel family 

- Can register without delay; same deadlines as existing F/FAs 

- Assures compatibility with other rules (e.g., RFG, detergents) 

"New" products = F/FAs not fitting criteria to group with registered 

fuels and bulk additives in same fuel family 

- Must complete all test requirements before registration 

- Includes any Tier 3 testing which may be prescribed 
P.15 

Figure 4. Determination of F/FA Registrability and Compliance Time Requirements 

© 

YES 

1 

YES 

' 

Registered and 

Registrable F/FAs: 

- Tier 1 compliance within 

3 yrs. of promulgation; 

Tier 2 compliance within 

6 yrs. of promulgatione 

- Additional time provided 

for Tier 3, if prescribed 

- Conditional registration 

continues during these 

compliance periods 

j* Any fuel or additive (bulk or 

Registered as of 

effective date of 

final rule 

NO 

" 

Fits criteria for grouping 

with a currently registered 

fuel or bulk additive in 

the same fuel familyb 

aftermarket). . 

u

 The term "currently" refers to the date on which EPA re< 

application for the fuel or fuel additive in question. 

c

 After this time period, a manufacturer of a registrable fu 

can usually rely on data previously submitted for a simil 

in the same group. 

M f i 

INU 

1 ' 

New (Not Registrable) 

F/FAs: 

- Compliance with all 

testing requirements 

(including Tier 3, if 

prescribed) prior to 

registration 

reives the registration 

el or additive 

ar registered product 
P.16 

SPECIAL PROVISIONS 
P.17 

GROUPING SYSTEM 

Objectives 

• Enables manufacturers of chemically similar products, on a voluntary 

basis, to share costs of program compliance 

• Minimizes duplicative efforts and redundant information 

• Eases demand on limited laboratory capacity 

• Decreases volume of material for EPA review and analysis 

General Principles 

• Groups are defined based on composition of "raw" F/FAs 

• Fuels and related fuel additives are grouped together, with additives 

sorted according to the characteristics of the associated in-use 

additive/fuel mixture 

• Producers of F/FAs in the same group can conduct cooperative 

evaluation and testing using a representative product selected according 

to EPA rules 

• Test results for representatives will be applied to all group members 

Framework (see Figure 5) 

• Each F/FA is first sorted into a Fuel/Additive Category within the 

applicable "fuel family" 

• Fuel families reflect basic chemical/physical properties and engine 

usage, e.g., unleaded gasoline and diesel families. For each fuel 

family, specifications for an average "base fuel" are given. 
(Grouping System, Cont'd) 

• Categories reflect the degree of similarity of a given F/FA to the base 

fuel in its family. With some exceptions, category definitions are: 

- Baseline: F/FAs having no elements other than those in the base 

fuel (generally, only C,H,0,N,S are allowed), and conforming to 

certain limits on some constituents 

- Non-baseline: F/FAs have same elements as permitted in Baseline, 

but exceed concentration limits 

- Atypical: Contain elements not included in Baseline 

• Each category may be further subdivided into one or more F/FA groups, 

depending on the variability of F/FAs within the category 

• Within each group, either the base fuel or a member F/FA is specified 

to represent the group in testing 

• Using the grouping criteria and 12/31/92 F/FA registration database, a 

total of 110 groups are projected (see Figure 6) 

Organization of F/FA Groups 

• Producers expected to determine appropriate groups for .their F/FAs 

• Enrollment and administration of groups to be brokered by industry 

• For disputes related to cost sharing and reimbusement arrangements, 

TSCA arbitration procedures can be used at manufacturers' request 
P.19 

Figure 5. Fuel/Additive Classification Hierarchy 

Fuel Families 

Conventional: 

Alternative: 

Gasoline 

Diesel 

Methanol 

Ethanol 

Methane (CNG, LNG) 

Propane (LPG) 

t 

Fuel/Additive 

Categories: 

- Baseline 

- Non-baseline 

- Atypical 

i 

Fuel/Additive 

Groups 

Group 

Representative(s) 
P.20 

Figure 6 : Estimated Groups Per Fuel/Fuel Additive Category 

F/FA Category 

Baseline1 

Non-Baseline1'

2 

Atypical3 

Fuel Family 

Gasoline 

1 Group 

307 Manufacturers 

1,58 6 Products 

,9 Groups 

120 Manufacturers 

476 Products 

5 6 Groups 

14 6 Manufacturers 

293 Products 

Diesel 

1 Group 

87 Manufacturers 

496 Products 

2 Groups 

1 Manufacturer 

2 Products 

41 Groups 

112 Manufacturers 

213 Products 

1 Excludes data for manufacturers who, under small business provisions of this 

rule, are exempted from test requirements for their baseline and non-baseline 

products (i.e., excludes manufacturers < $50 million in sales). 

2Non-baseiine products can fall into more than one group depending upon the number 

of oxygen compounds they contain. Thus, they are counted multiple times in trie 

table depending upon the number of groups they fall into. 

'Includes data for manufacturers who are exempted from a portion of the test 

requirements for these products under the small business provisions of thi3 rule 

(i.e., includes manufacturers < $10 million in sales). 
P.21 

ALTERNATIVE TIER 2 PROVISION 

• In some cases, EPA may be able to define specific health effect 

concerns instead of, or in addition to, the broad screening studies of Tier 

2. For example: 

- Some Tier 2 tests may not be reasonable for certain F/FAs (e.g., 

cancer tests for CNG) 

- EPA's concerns about a certain F/FA may already be narrowed down 

— more rigorous tests needed just in one or two areas 

- EPA may be concerned about an endpoint not specifically targeted in 

Tier 2 (e.g., hepatotoxicity, endocrine toxicity) — additional 

evaluations done in conjunction with Tier 2 could save costs in the 

long run 

• Thus, final rule retains EPA authority to modify Tier 2 testing 

requirements for specified F/FA groups 

• F/FA manufacturer(s) will be notified of required alternative test 

program within nine months of promulgation. 

• EPA may contact manufacturer at a later time, but compliance with 

alternative test program will then be voluntary. 
P.22 

SMALL BUSINESS PROVISIONS 

Authority: §211(e) authorizes EPA to define a small business for this rule 

and to provide modifications or exemptions for such companies 

Definition: Company with annual sales less than $50 million 

• Based on examination of distribution of registered companies by sales: 

tend to cluster under $50M and over $100 M (see Figures 7 and 8) 

• This definition results in greater number of "small" companies than 

SBA definitions 

Provisions: Depend on type of product and further sales breakdown 

1. All small companies are exempt from standard Tier 1 and Tier 2 

responsibilities for their baseline and nonbaseline products 

Rationale: EPA's data needs for such products will be furnished by 

larger companies with products in same F/FA groups. 

2. Companies with sales less than $10 million also have reduced 

responsibilities for atypical products — must do Tier 1 only 

Rationale: 

• Full exemption would often result in EPA having no data furnished 

for these F/FAs, because larger companies less likely to have 

products in atypical groups 

• Still, requirements for atypicals are relatively high, especially since 

there are fewer grouping (cost sharing) opportunities 

• Compromise provision for atypical products of smallest companies: 

no bio test data, but emission characterization and lit search data 

must be provided for EPA's initial evaluation. If warranted, 

toxicologic testing could still occur at Tier 3. 
P.23 

Figure 7 Fuel Manufacturer Annual Sales Distribution 

Manufacturers of Leaded Products Excluded 

Figure 7a 

_ 

(0 V) 

"5 

3 

C 

C 

< 

& 

"o 

c 

.2 

_ 

_ 

Figure 7b 

0 5 10 15 2025303540455055606570758085909 5 100 

Cumulative Percent of 638 Companies 

<10 10-49 50-99 

Annual Sales ($ Millions) 

•>100 

Figure 7c 

120 

100 -

c 

o 

I 80 

<2 6 0 

% 

~ 40 

3 

C 

20 

-

-

-

_.. ___.._ 

Fuel Mfrs. Earning < $100M Per Year 

• • 

* 

$50 MILLION _ / 

J_~- " 

_ _ »...--_ - • _--*"^* ^ 

__„. • _.—«-—» ^ 

_ _ • • — T , i ... 1. L 1 1 1 1 1 1 1 1 1 1 1 • 

10 20 30 40 50 60 70 80 

Cumulative Percent of 525 Comoanies < $100 MM 

90 100 
P.24 

Figure 8 Fuel Additive Manufacturer Annual Sales Distribution 

Manufacturers of Leaded Products & Relabeiers Excluded 

Figure 8a 

(A 

_ 

3 

C 

C 

< 

O 

Q 

---$io,oeo-

-$100---

$1.0 

_J I I 

Figure 8b 

Figure 8c 

- i 1 1 i i i • ' ' 

10 20 30 40 50 60 70 

Cumulative Percent of 456 Companies 

<10 10-49 50-99 

Annual Sales ($ Millions) 

80 90 100 

• 200 

e pan 

E 150 

<3 < M 

o 

1

1 0 ° 

E 3 

Z

 50 

n 

^ ^ ^ 

____________B_______i 

^^^E____H 

______________________ 

^^^^^^H —————————————————_H 

____________________H 

^^^^^H 

______________________ 

______________________ 

~ ______ I 

^^^^^^^^^^^^ 

^^^^^^l ^^^^^^^__^^^________i 

_________• ^m|^_ 

____________________[ _____________________! 

___________H_______I _____________________i 

_____i___i ___________! 

->100 

100 

In 80 

c 

o 

%» 60 

3 

W 40 |-

_ 

3 C 

< 20 

Fuel Addtttve Mfre. Earning < $100M Per Year 

$50Mlfflon 

_ - " 

*-•-• -

• ' ' u 

10 2030405060708 0 

Cumulative Percent of 314 Companies < $100 MM 

90 100 
P.25 

OTHER SPECIAL PROVISIONS 

• Relabeled additives 

- Repackaged versions of other manufacturers' products 

- Exempt from all standard requirements except basic registration 

- Accounts for about a quarter of currently registered additive products. 

- About 40% of additive "manufacturers" have relabeled additives only 

• Aerosol additives 

- Examples: carburetor cleaners, starter fluids 

- Exempt from standard Tier 1 and Tier 2 requirements; must do only 

a lit search and qualitative exposure analysis on the raw product 

- Testing, if any, will be tailored to the product type and composition 

and will occur under Tier 3 

• Experimental F/FAs ~ exempt from registration processes in general 

• Provisions allowing requests for modified testing procedures to give 

additional flexibility in special cases, including: 

- Intermittent-use aftermarket additives 

- "Distribution system" additives (e.g., biocides) 

- Additives used to enhance performance of exhaust aftertreatment 

devices 

- Evaporative emission generation approaches 
P.26 

ECONOMICS 
P.27 

PROGRAM COSTS 

• Total industry-wide costs for Tiers 1 and 2 projected to be $66 million, 

spread over first 3- 6 years. Projected Tier 3 costs might be $10 

million per year in subsequent years. 

• Estimated cost for Tiers 1 & 2, per group or solo product (Figure 9) 

- Generally varies in the range of $440K-800K, depending on category 

(baseline, nonbaseline, atypical), availability of existing information, 

and applicability of evaporative emission requirements 

- For atypical products of a small business (under $10M sales), cost 

varies in the range of $110K-270K (Figure 10) 

• Estimated cost per manufacturer (Figure 11) 

- Depends on number and types of F/FAs, opportunities for costsharing, applicability of special provisions 

- Varies in the range of $400 to over $3.7 million 

• Median cost = $500 

• 82 percent have costs less than $10,000 

• Less than 1% of companies have costs greater than $1 million 

• Small business impacts (Figures 12 and 13) 

- With special provisions, small business costs are generally less than 

large businesses 

- Nevertheless, RFA projects 12 very small companies with atypical 

F/FAs could face closure as a result of compliance costs (Figure 13). 

- This result ignores companies' likely strategic responses in terms of 

product pricing, product mix, and formulation. 
Figur e 9. Estimate d Complianc e Costs Pe r Group* 

1 

Tier 1: 

Literature Search 

Acquisition 

Mileage Accumulation 

Combustion Gen./Charact 

Evaporative Gen./Charact 

• 

Tier 2: 

Combustion Generation 

SM Sampling 

Evaporative Generation 

Biological Testing 

Administrative Costs 

TOTAL (Rounded): 

Gasoline Fuel Family 

Baseline 

$21,000 

30,000 

6,400 

25,850 

6,275 

71,500 

500 

58,500 

550,800** 

26,335 

$797,000 

Non-Baseline 

$7,000 

30,000 

6,400 

35,750 

6,775 

71,500 

500 

58,500 

550,800** 

26,335 

$794,000 

Atypical 

$7,000 

30,000 

48,000 

58,550 

0 

71,500 

500 

0 

280,100 

26,335 

$522,000 

Diesel Fuel Family 

Baseline 

$21,000 

37,200 

27,500 

13,000 

N/A 

58,500 

0 

N/A 

260,600 

26,335 

$444,000 

Non-Baseline 

$7,000 

37,200 

27,500 

34,700 

N/A 

58,500 

800 

N/A 

280,100 

26,335 

$472,000 

Atypical 

$7,000 

18,600 

191,400 

45,400 

N/A 

58,500 

800 

N/A 

280,100 

26,335 

$628,000 

*Costs i n thi s tabl e ar e applicabl e t o manufacturer s not qualifying fo r specia l provisions. 

••Conducted on both combustion and evaporativ e emissions. 
P.29 

Figure 10. Estimated Compliance Costs for 

Small* Atypical Manufacturers 

Tier 1: 

Literature Search 

Acquisition 

Mileage Accumulation 

Combustion Gen./Char. 

Evaporative Gen./Char. 

Tier 2 

Administrative Costs 

TOTAL (Rounded): 

Gasoline 

Fuel Family 

$7,000 

15,000 

24,000 

58,550 

0 

Exempt 

9,450 

$114,000 

Diesel 

Fuel Family 

$7,000 

18,600 

191,400 

45,400 

N/A 

Exempt 

9,450 

$272,000 

*Those manufacturers with sales under $10 million. 
P.30 

Figure 11 : Distribution of Compliance Costs 

for 1403 Fuel and Additive Manufacturers Combined (Including Relabeiers) 

' llWl_M__M__B__WBWMim____88 

800 

600 -

i 

2 

_ 

400 

200 -

$0-490 $500-1K $1-5K $S-10K $10-50K $50-100K $100-500K $500K-1M $1 - 4M 

Cost to Manufacturers 
P.31 

Figure 12. 

Summary of Compliance Costs per Manufacturer 

Type of 

Manufacturer 

Minimum 

Additive Manufacturers 

Small 

Large 

Total 

Fuel Manufacturers 

Small 

Large 

Total 

$400 

$400 

$400 

$400 

$400 

$400 

Median 

$500 

$5,029 

$915 

$500 

$10,988 

$500 

Maximum 

$1,207,891 

$3,717,296 

$3,717,296 

$500,900 

$1,672,700 

$1,672,700 

% with costs 

> $10,000 

25% 

43% 

31% 

3% 

53% 

16% 
Figure 13. 

Summary Profile of Manufacturers 

Potentially Pushed into Closure 

P.32 

Manufacturer's Product 

Mix* 

Total 

1 

1 

6 

1 

4 

4 

1 

3 

3 

7 

18 

3 

Atypical 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 

#of 

Employees 

6 

1 

4 

4 

4 

3 

2 

4 

4 

0 

4 

2 

3 

Annual 

Sales 

$110,000 

$166,096 

$260,000 

$240,000 

$310,000 

$340,000 

$85,000 

$430,000 

$300,000 

$340,000 

$410,000 

$280,000 

$272,593 

Compliance 

Cost 

$272,400 

$272,400 

$500,900 

$272,400 

$386,701 

$386,701 

$114,400 

$272,600 

$228,600 

$229,000 

$230,100 

$114,600 

$273,400 

ROA 

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% 

Adjusted 

ROA 

-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% 

•The first cohimn indicates total number of products, the second cohimn is number of atypical 

products, and the third cohimn is number of baseline products. 
P.33 

*• 

SUMMARY 

Workgroup closure on final rule is scheduled for May 10, 1994 

Formal rulemaking package will be delivered to OMB shortly thereafter, 

including: 

- Preamble 

- Regulations 

- Regulatory Support Document/Regulatory Flexibility Analysis 

- Information Collection Request 

- Request for OMB Review (SF83) 

- Federalism Review 

Should be very similar to drafts provided previously 

Timetable: Final rule must be signed on May 27th