P.1 

OAR Box 1846 

Prepped by Ollie Stewart 

Document Number: 

52) ll-F-6 

Docket Number: 

A-90-07 

Printed 11/18/2008 7:30:16 AM Sheet 52 of 93 
P.2 

A-90-o7 

ZUL-t- otp 

NOTICE OF PROPOSED RULEMAKING: 

FUELS AND FUEL ADDITIVES 

REGISTRATION PROGRAM 

ULiI JU. S;.A; Uj 

[ EPAAIRDQCKFT 

Briefing for the 

Office of Management and Budget 

November 22, 1991 

Emission Control Technology Division 

Office of Mobile Sources 

Office of Air and Radiation 

U.S. Environmental Protection Agency 

m 
P.3 

BACKGROUND 
P.4 

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(b)(2). EPA 

enters into consent decree setting the following schedule: 

• ANPRM due August 1, 1990 

• NPRM due January 1, 1992 

• Final rule due June 1, 1993 

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) 

NPRM development and workgroup closure. 
P.5 

PROGRAM SCOPE 
P.6 

GENERAL FOCUS 

Major focus is on determination of potential adverse health effects 

- Uses tiered evaluation approach, emphasizing literature research and 

short-term testing methods with allowance for more rigorous studies 

as required 

- Recognizes adequate existing data in lieu of duplicative testing 

- Provides for voluntary grouping and cost sharing by producers of 

similar F/FAs, to further minimize compliance burdens 

• Addresses effects of F/FA emissions only, not "raw" (liquid) F/FAs 

- Consistent with general objectives of Clean Air Act as a whole, 

legislative intent of Section 211, and scope of regulatory authority 

under 211(c) 

- Includes both combustion and evaporative emissions 

- Applicability of evaporative emission requirements depends on F/FA 

volatility 

Addresses atmospheric transformation products only through analytic 

methods. For now, actual lab testing requirements precluded by 

scientific and technical limitations. 
P.7 

SCOPE OF HEALTH EFFECTS PROVISIONS 

Focus 

• Potential adverse effects of inhalation exposure to F/FA emissions 

Endpoints 

• Required by statute: carcinogenicity, mutagenicity, teratogenicity 

• Additional endpoints proposed: adult reproductive, pulmonary, and 

neurologic effects 

Approach (see Figure 1) 

• Components of evaluation organized within three successive tiers: 

Tier 1: Emission characterization, literature search, and modeling 

Tier 2: Short-term biological testing 

Tier 3: Additional testing, if any, following EPA's review of 

submittal; tailored to needs identified in Tiers 1 and 2 

• Requirements of Tiers 1 and 2 can be satisfied by adequate existing 

information 

- "Adequacy" depends on exposure scenario, dosages, and duration, 

technical and statistical methods, completeness of documentation, age 

of data, et al. 

• Three-year compliance time (or pre-registration requirement) pertains 

only to Tiers 1 and 2 
P.8 

Figure 1: Overview of Evaluation Tiers 

START 

-L 

Tierl 

° Characterization of emissions 

o Summary of previous health 

and environmental studies 

° Analyses of atmospheric reactivity, 

exposure potential, and environmental 

partitioning 

Inadequate 

existing 

information 

Tier I 

Short-term tests for carcinogenic, 

mutagenic, teratogenic, reproductive, 

pulmonary, and neurologic effects 

EPA evaluation of Tier 1 & 2 data and 

decision on need for additional testing 

Additional 

testing 

needed 

Additional tests (e.g. long term animal 

exposures and/or further emission 

characterization) prescribed on a 

case-by-case basis, to clarify, verify, or 

quantify the results of Tiers 1 & 2. 

END 

Adequate 

existing 

information 

Additional 

testing 

not needed 

* "Adequate" implies that the existing information includes the results of 

properly performed and well-documented studies comparable to the tests required 

in Tier 2. 
P.9 

SCOPE OF WELFARE EFFECTS PROVISIONS 

Background 

• Section 211(b) specifies only that "reasonable and necessary" 

information be furnished on the welfare effects of F/FA emissions 

• Specific welfare effects endpoints not stipulated and testing not required 

by the statute 

• Scientific experience and screening methods for welfare effects are more 

limited than for health effects 

• Other EPA programs focus on contribution of F/FA emissions to major 

environmental problems such as acid rain, global warming, and ozone 

effects 

Proposed Approach 

• Address welfare effects through literature research and modeling 

methods rather than laboratory testing 

• These requirements conducted in conjunction with Tier 1 of health 

effects evaluation 

• Comments are requested on possibility of including welfare effects 

testing in Tier 3 when Tier 1 demonstrates significant environmental 

toxicity potential 
P.10 

SCOPE OF EMISSION CONTROL SYSTEM PROVISIONS 

Background 

• Section 211(b) authorizes testing to determine F/FA impact on the 

ability of ECS equipment to comply with emission standards 

• Significant overlap with Section 211(f) rules first implemented in 1977 

- Establishes criteria for F/FAs considered "substantially similar" to 

certification fuels 

- For F/FAs that are not "sub-sim", requires ECS testing to obtain a 

waiver allowing introduction into commerce 

• Applicability of Section 211(f) 

- In the past, applied only to unleaded gasoline and its bulk additives 

- 1990 CAA Amendments extended 211(f) authority to other F/FA 

types, e.g., diesel and "alternative" fuels. "Sub sim" rules for these 

fuels are planned. 

- Under "grandfathering" provision, still does not apply to non-gasoline 

F/FAs and aftermarket gasoline additives introduced pre-1990 

Proposed Approach 

• Continue 211(f) jurisdiction for ECS testing 

• To address concerns about grandfathered F/FAs, EPA may (at its discretion) require waiver appUcation for particular F/FAs upon petition of 

vehicle manufacturers or other interested parties 
P.11 

PROVISIONS REDUCING COMPLIANCE BURDEN 

Addresses emissions effects only 

Recognizes existing information 

Exempts "relabeled" products 

Limits applicability of evaporative emission testing 

Limits routine health effects testing to short-term studies 

Provides for group testing, information submittal, and cost sharing 

Limits welfare effects provisions to analytic methods 

Integrates emission control system provisions with existing waiver 

program 

Other possible provisions/exemptions presented for public comment: 

- Possible exemptions for "de minimis" factors such as "sub-sim" 

additives used in very small amounts or "non-sub-sim" additives with 

negligible concentrations of elements of concern 

- Possible temporary exemptions for experimental F/FAs used for 

research, development, and evaluation, and not yet in commercial 

distribution or wholesale/retail sale. 
P.12 

GROUPING SYSTEM 
P.13 

GROUPING SYSTEM OVERVIEW 

Objectives 

• Enable manufacturers of chemically similar products, on a voluntary 

basis, to share costs of program compliance 

• Minimize duplicative efforts and redundant information 

• Ease demand on limited laboratory capacity 

• Decrease volume of material for EPA review and analysis 

General Principles 

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

composition of emissions not yet known 

• Fuels and related fuel additives are grouped together 

• Additives are sorted according to the characteristics of the associated inuse 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 
P.14 

FRAMEWORK 

Each F/FA is first sorted into a Fuel/Additive Category defined by the 

applicable "fuel family" and "formulation class." (see Figures 2 - 4) 

• Fuel families reflect basic chemical/physical properties and engine 

usage, e.g., unleaded gasoline and diesel families 

- A "base fuel", representing the industry average, is to be defined for 

each family 

Formulation classes reflect the degree of similarity to the base fuel in 

each family 

- Baseline: F/FAs limited as to permissible elements and, in some 

cases, as to the amounts of such elements. (Various alternative 

criteria are presented for comment) 

- Non-baseline: Contain 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 group(s), 

depending on the variability of F/FAs within the category (various 

alternatives proposed for comment) 

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

represent the group in testing 
Figure 2: Fuel / Additive Classification Hierarchy 

Conventional 

Unleaded Gasoline 

Leaded Gasoline 

Diesel 

Alternative 

Methanol 

Ethanol 

Methane (CNG, LNG) 

Propane (LPG) 

— Fuel Families X. Formulation Classes 

Baseline 

Non-Iluseline 

Atypical 

Fuel/ Additive 

Categories 

Fuel / Additive 

Testing Groups 

Group 

Representatives 
FIGURE 3: FUEUADDITIVE CATEGORIES 

FORMULATION 

CLASSES 

(1) 

BASEUNE 

FORMULATIONS 

(2) 

NON BASEUNE 

FORMULATIONS 

(3) 

ATYPICAL 

FORMULATIONS 

•CONVENTIONAL" FUEL FAMILIES 

UNLEADED GASOUNE 

(A) 

BASELINE 

UNLEADED GASOUNE 

CATEGORY 

ONE GROUP 

REPRESENTED BY 

UNLEADED 

BASE FUEL 

NONBASELINE 

UNLEADED GASOUNE 

CATEGORY 

GROUPED ACCORDING 

TO PRESENCE OF 

NONBASELINE 

FACTORS 

ATYPICAL UNLEADED 

GASOLINE CATEGORY 

GROUPED ACCORDING 

TO ATYPICAL 

ELEMENTS 

AND OTHER 

CHARACTERISTICS 

LEADED GASOLINE 

18) 

BASELINE 

LEADED GASOLINE 

CATEGORY 

ONE GROUP 

REPRESENTED BY 

LEADED 

BASE FUEL 

NONBASELINE 

LEADED GASOLINE 

CATEGORY 

GROUPED ACCORDING 

TO PRESENCE OF 

NON-BASEUNE 

FACTORS 

ATYPICAL LEADED 

GASOUNE CATEGORY 

GROUPED ACCORDING 

TO ATYPICAL 

ELEMENTS 

AND OTHER 

CHARACTERISTICS 

DIESEL 

(C) 

BASEUNE 

DIESEL 

CATEGORY 

ONE GROUP 

REPRESENTED BY 

DIESEL 

BASE FUEL 

NON BASEUNE 

DIESEL 

CATEGORY 

GROUPED ACCORDING 

TO PRESENCE OF 

NON-BASEUNE 

FACTORS 

ATYPICAL OIESEL 

CATEGORY 

GROUPED ACCORDING 

TO ATYPICAL 

ELEMENTS 

AND OTHER 

CHARACTERISTICS 

•ALTERNATIVE" FUEL FAMILIES 

METHANOL 

(>-50% MeOH BY VOL) 

(0) 

BASEUNE 

METHANOL 

CATEGORY 

TWO GROUPS 

(M96M100 AND 

M50-M95) 

REPRESENTED BY 

Ml 00 AND MBS 

BASE FUELS 

NONBASELINE 

METHANOL 

CATEGORY 

GROUPS 

TBA 

ATYPICAL METHANOL 

CATEGORY 

GROUPS 

TBA 

ETHANOL 

(> = 50y. EtOH BY VOL) 

(E) 

BASEUNE 

ETHANOL 

CATEGORY 

TWO GROUPS 

(E9^E10O AND 

E50 E95) 

REPRESENTED BY 

ElOO AND E85 

BASE FUELS 

NONBASELINE 

ETHANOL 

CATEGORY 

GROUPS 

TBA 

ATYPICAL ETHANOL 

CATEGORY 

GROUPS 

TBA 

METHANE 

(CNG. LNG) 

(F) 

BASE1INE 

METHANE 

CATEGORY 

TWO GROUPS 

(CNG AND LNG) 

REPRESENTATED BY 

CNG AND LNG 

BASE FUELS 

NON BASELINE 

METHANE 

CATEGORY 

GROUPS 

TBA 

ATYPICAL METHANE 

CATEGORY 

GROUPS 

TBA 

PROPANE 

(LPG) 

(G) 

BASEUNE 

PROPANE 

CATEGORY 

ONE GROUP 

REPRESENTED U Y 

LPG BASE FUEl 

NON BASELINE 

PROPANE 

CATEGORY 

GROUPS 

TBA 

ATYPICAL PROPANE 

CATEGORY 

GROUPS 

TBA 

' EACH CATEGORY CONTAINS ONE OR MORE FUEUADDITIVE GROUPS. 

HEALTH EFFECTS TESTING INFORMATION IS REQUIRED FOR EACH SUCH FUEL/ADDITIVE GROUP 
P-17 . 

Figure 4: Groups, Manufacturers, and Products 

in Selected Fuel/Additive Categories 

Formulation 

Class 

Baseline 

Formulations 

Non-Baseline 

Formulations 

Atypical 

Formulations 

Fuel Family 

Unleaded 

Gasoline 

1 Group 

527 Manufacturers 

1530 Products 

17 Groups 

645 Manufacturers 

976 Products 

48 Groups 

137 Manufacturers 

197 Products 

Diesel 

1 Group 

305 Manufacturers 

769 Products 

1 Group 

2 Manufacturers 

2 Products 

47 Groups 

148 Manufacturers 

223 Products 
P.18 

IMPLEMENTATION ISSUES 

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 

• Third-party mechanisms may be useful to reduce potential problems 

regarding confidential business information 

Cost-sharing Provisions 

• Initial proposal leaves development of these provisions up to the 

participants. Needs to account for: 

- Prospective cost-sharing arrangements 

- Reimbursement arrangements 

• Alternative EPA-administered mechanisms are presented for comment 
P.19 

EVALUATION OF 

HEALTH/WELFARE EFFECTS 
P.20 

EMISSION GENERATION 

Controlled generation and sampling of emissions for: 

- Emission characterization: brief collection period, storage, and use 

- Biological testing: continuous generation and routing of diluted 

emissions to testing chambers 

• Proposal seeks balance between desire for certainty and practical 

constraints, regarding number of vehicles, new vs. used vehicles, and 

mileage requirements 

- Basic proposal: one new vehicle, minimum of 25,000 accumulated 

miles prior to emission generation, for each subject F/FA 

- Alternative proposal: 6 vehicles, new or used, minimum of 4,000 

accumulated miles. Multiple F/FAs can use same vehicles, with 

preconditioning cycle in between. All vehicles used for emission 

characterization, with one selected for biological testing. 

For F/FAs with atypical elements, mileage accumulation must continue 

until emissions "steady state" or 80% of vehicle useful life is reached 

• Combustion emission generation involves repeated FTPs 

Evaporative emission generation uses FTP-SHED method for emission 

characterization, evaporative chamber for biological testing 
P.21 

TIER 1: EMISSION SPECIATION 

Functions 

• Satisfies statutory provision to "determine the emissions" of F/FAs 

• Provides inventory of potentially hazardous motor vehicle emissions, and 

provides basis for analytical and modeling studies 

Requirements (see Figure 5) 

• Focus on measurement of regulated emissions and on detection and 

measurement of selected chemical classes and compounds of interest 

• Depending on F/FA and emission type, includes: 

- Total hydrocarbons, NOx, CO, and particulate 

- Speciation of hydrocarbons, ketones and aldehydes, alcohols and 

ethers, PAH and NPAH 

• F/FAs with atypical elements must be analyzed for the emissions fate of 

the elements of concern 
P.22 

Figure 5: Emission Characterization Requirements 

Emission Type RE HC Ket Ale PAH NPAH 

& & 

Aid Eth 

Combustion Emissions 

Vapor phase emissions 

Semi-volatile phase emissions 

Particulate phase emissions 

X X* 

X 

X 

X 

X 

Evaporative Emissions ** 

Diurnal emissions 

Hot soak emissions 

X 

X 

X 

X 

X* 

X* 

* Required if alcohols or ethers exist in the uncombusted fuel 

** Only applicable to fuels/additives required to measure evaporative emissions 

RE=regulated emissions, HC=hydrocarbons, Aid & Ket=aldehydes and ketones 

Ale & Eth=alcohols and ethers, PAH=polycyclic aromatic hydrocarbons, 

NPAH=nitrated polycyclic aromatic hydrocarbons 
P.23 

TIER 1: DATA RESEARCH AND ANALYSIS 

Literature Search 

• Functions 

- Furnish EPA with comprehensive summary of existing information on 

composition/toxicity of F/FA emissions 

- Document the extent to which existing data can satisfy emission 

characterization and Tier 2 requirements 

• Requirements 

- Search of pubhshed and in-house sources of information on effects of 

whole and speciated emissions 

- Search of toxicologic and environmental data bases 

- May include epidemiologic, clinical, animal-based, and field studies 

Modeling Approaches 

• Estimate ambient exposures to F/FA emissions 

• Project atmospheric transformation products using models and/or 

theoretical chemical analysis 

• Evaluate potential environmental partitioning of emissions to air, soil, 

water, and biota 
TIER 2 REQUIREMENTS 

In general, includes short-term (42-day) inhalation exposures of animals to 

F/FA emissions at three dilutions, to screen for the following effects: 

Carcinogenicity and Mutagenicity 

• Ames Reverse Mutation Assay 

• In Vivo Micronucleus Assay 

• In Vivo Sister Chromatid Exchange 

Developmental Toxicity (Teratogenicity) 

• Exposure of animals during sensitive period of pregnancy with 

subsequent analysis of effects on fetus 

Reproduction/Fertility Effects 

• Exposure of adult males and females before and after mating, with 

analysis of effects on adult reproductive structures and number and 

viability of offspring 

Pulmonary Toxicity 

• Examination of lung tissues, cells, and biochemistry following 

inhalation exposure 

Neurotoxicity 

• Functional observational battery on live animals throughout 

exposure period 
P.25 

TIER 3 REQUIREMENTS 

Criteria for Escalation to Tier 3 

• Based on identification of important information gaps or uncertainties in 

toxicity data, with qualitative consideration of exposure potential 

• General decision criteria include: 

- Number of positive and negative outcomes for each endpoint 

- Identification of concentration-effect relationships 

- Statistical sensitivity and significance of studies 

- Severity of observed effects 

- Number of species involved in reported tests 

- Consistency and clarity of apparent mechanisms, target organs, and 

outcomes 

- Nature and amount of known toxic agents in the emissions stream 

Tier 3 Testing 

• Requirements determined on case-by-case basis to address specific areas 

of uncertainty identified in Tier 1 and/or Tier 2 

• May include further emission characterization, longer-term biological 

testing, and/or exposure studies 
P.26 

RELATIONSHIPS WITH REFORMULATED GASOLINE (RFG) 

• RFG Program is a key regulatory change in the motor vehicle fuels area 

- Much work done in development of this mandatory program 

- Useful to learn from that experience and to be compatible and 

complementary when possible, since F/FA program applies to RFGs 

• Timing factors: 

- Phase 1 RFG: 1995 

- F/FA Rule: 1996 

- Phase 2 RFG: 1997 

• Two major areas for consideration: 

1. Emission Generation/Characterization 

- F/FA and RFG programs designed for different purposes and give 

different results 

- Similar vehicle selection, sample size, and mileage accumulation 

- Similar analytic requirements 

- Compatible data can be used 

2. Groupings 

- RFG subject to testing under F/FA program 

- Scope.of F/FA program for Phase 1 RFG depends on grouping 

scheme 

- Based on grouping considerations, Phase 2 RFG will probably not 

have to retest unless new compounds are added 
P.27 

ECONOMICS 
P.28 

PROGRAM COSTS 

Estimated industry-wide costs for Tiers 1 and 2 would approximate $83 

million over the first three years after the final rule, i.e., about $27 

million/year 

Estimated cost per manufacturer (see Figure 6) 

- Depends on number and types of F/FAs and opportunities for costsharing 

- Might vary from $500 to over $2 million, with median cost of. about 

$2000 

• Estimated cost per individual product 

- Depends on type of product, availability of existing information, and 

applicability of evaporative emission requirements 

- For a solo atypical additive which is subject to evaporative emission 

requirements and has no existing information (worst case), estimated 

costs total about $1.3 million: 

Tier 1 $ 114,750 

Tier 2 993,380 

Administration 156.900 

Total $ 1,265,030 

Projected Tier 3 costs might be $10 million per year in subsequent three 

years 
CO 

CD 

O 

CO 

crj 

800 

700 

600 

500 

400 

O 

l _ 300 

CD 

-Q 

£ 200 

100 

Figure 6: Distribution of Compliance Costs 

for Fuel and Additive Manufacturers Combined 

150 

667 

i 

[fill 

9 

fBuwwuguuHi 

109 

'&&*',& J! 

37 

80 

42 

liMill 

14 

WnttMii Ka&gSasaga 

100-500 1K-5K 10K-50K 100K-500K 1M-1.5M 

500-1000 5K-10K 50K-100K 500K-1M 1.5M+ 

Cost to Manufacturer (dollars) 
P.30 

SMALL BUSINESS PROVISIONS 

Authority 

• Under Section 211 (e)(3), EPA mav modify the F/FA registration requirements for small businesses 

• "Small business" is to be defined within the regulations 

Initial Proposal 

• No special allowances for small businesses in consideration of costreduction provisions for all manufacturers 

• Difficult to define "small business" on factors other than financial status 

Impact on Small Businesess (as defined bv SBA) 

• On average, small companies have lower compliance costs than large 

ones, but are more vulnerable to cost burdens 

• Costs for 85% of small fuel companies and 80% of small additive 

companies estimated at less than $10,000 

• No significant impact on small fuel companies, but 23 (6%) of small 

additive manufacturers might experience financial distress and 2 might 

be pushed into closure (ROA < -30%). 

Possible Provisions 

• Further analysis planned to identify specific vulnerabilities 

• Partial mitigation of requirements may be considered 
P.31 

SUMMARY 

NPRM package coming to OMB shortly includes the following: 

- Preamble 

- Regulations 

- Regulatory Support Document 

- Regulatory Flexibility Analysis 

- Information Collection Request 

- Communication Strategy 

- Request for OMB Review (SF83) 

- Federalism Review 

Timetable 

- Per consent decree, deadline for proposal is January 1, 1992