P.1 

OAR Box 1846 

Prepped by Ollie Stewart 

Document Number: 

46) ll-E-6 

Docket Number: 

A-90-07 

Printed 11/18/2008 7:30:16 AM Sheet 46 of 93 
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A -90-07 

U-£-0U> 

FUELS AND FUEL ADDITIVES 

REGISTRATION PROGRAM 

Potential Issues 

for 

Regulatory Negotiation 

Washington, D.C. 

May 2, 1991 

Emission Control Technology Division 

Office of Mobile Sources 

Office of Air and Radiation 

U.S. Environmental Protection Agency 

m 
P.3 

OVERVIEW 

Background 

• Statutory Provisions 

• Timelines 

• Fuels and Fuel Additives Registration Database 

Program Components 

• Scope of Health Effects Provisions 

• Scope of Welfare Effects Provisions 

• Treatment of Conventional Fuels 

• Assessment of Health/Welfare Effects 

• Emission Control System Provisions 

Other Program Issues 

• Grouping of Fuels and Fuel Additives 

• Small Business Provisions 

Important Note: 

This document outlines EPA's current perspectives on some of the issues involved in the 

development of new regulations for the registration of motor vehicle fuels and fuel 

additives. These views are presented for the purpose of initiating constructive discussion, 

and should not be construed as final decisions or formal rulemaking proposals. 

- 2 -
P.4 

BACKGROUND 

- 3 -
P.5 

STATUTORY PROVISIONS 

Clean Air Act Sections 211(b)(2) and 211(e) 

Specifies registration requirements for new motor vehicle fuels and fuel 

additives (F/FAs) 

- Applicable to both current and new F/FAs 

• Grants authority to EPA to collect information on potential adverse 

effects of F/FAs 

- Regulatory control based on such information would require follow-on 

rulemaking under Section 211(c) 

Requires manufacturers to assess: 

- 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 

Authorizes special provisions for: 

- Small businesses 

- Cost-sharing arrangements 

- Avoidance of duplicative information 

- 4 -
P.6 

TIMELINES 

Rulemaking Deadlines (per Consent Decree) 

Notice of Proposed Rulemaking (NPRM) due January 1, 1992 

• Final rales due June 1, 1993 

Compliance deadlines (per Statute) 

For F/FAs already registered when final rales published: three years 

from final rulemaking (June, 1996) 

For new products: prior to registration 

- 5 -
P.7 

FUELS AND FUEL ADDITIVES 

REGISTRATION DATABASE 

Fuels 

• 2,235 gasoline and diesel fuels registered by 764 manufacturers 

• 2,139 contain additives, 96 contain no additives 

• Includes 1,304 no-lead gasolines, 718 leaded gasolines, 59 #1 diesel 

fuels, and 154 #2 diesel fuels 

• Registration for alternative fuels is planned for the near future 

Additives 

Classification 

Bulk 

Aftermarket 

Both 

Total 

Number of 

Manufacturers 

180 

930 

50 

1,160 

Number c 

Additives 

1,673 

2,429 

13 

4,115 

- 6 -
P.8 

PROGRAM COMPONENTS 

- 7 -
P.9 

SCOPE OF HEALTH EFFECTS PROVISIONS 

General Approach 

• Establish requirements that are both reasonable and necessary for 

regulatory decision-making 

• Find appropriate balance between information needs and technical/economic constraints 

• Use tiered testing approach, emphasizing relatively short-term 

screening with allowance for more rigorous studies as required 

Focus on effects of F/FA emissions only 

• Consistent with specific statutory intent of Section 211 and general 

objectives of Clean Air Act as a whole (per current interpretation from 

EPA's Office of General Counsel) 

• Includes assessment of effects of inhalation exposure to combustion 

emissions and evaporative/refueling emissions 

• Assessment of effects of oral/dermal exposure to "raw" F/FAs is in 

the domain of other programs, e.g., TSCA 

Role of atmospheric transformation products 

• Some of these products may pose significant health risks 

• Reasonable to require analytic assessment, but actual lab test requirements precluded by scientific and technical limitations 

• More definitive evaluation may be needed in the future 

- 8 -
P.10 

SCOPE OF HEALTH EFFECTS PROVISIONS 

(Continued) 

Specific Health Endpoints to be Addressed 

• Minimum statutory requirements: 

- Carcinogenicity 

- Mutagenicity 

- Teratogenicity 

• Planned in addition: 

- Extension of teratogenicity testing (in-utero effects) to include 

study of adult reproductive effects 

- Pulmonary toxicity 

Topics For Discussion 

• Many other health endpoints may be of concern, e.g., neurotoxic 

effects, renal effects, chronic inhalation effects 

• Which (if any) are reasonable to include as general program requirements and necessary for regulatory decision-making? 

_ q_ 
P.11 

SCOPE OF WELFARE EFFECTS PROVISIONS 

Planned Approach 

• Focus on public welfare and environmental effects of air pollution 

• Assessment expected to rely on literature research and data analysis 

rather than laboratory testing, because: 

- Statute calls for "reasonable and necessary" information on welfare 

effects, without specific requirement to conduct tests 

- Limited scientific testing experience 

- Lack of practical screening approaches 

- Significant overlap between health and environmental effects 

- Overlap with other EPA programs assessing contribution of F/FAs 

to major environmental problems such as acid rain and global 

warming 

Topics for Discussion 

• Is this approach adequate to fulfill the statutory requirements? 

• Are there specific welfare issues which should be more definitively 

addressed within the program? If so, how? 

-10 -
P.12^ 

TREATMENT OF CONVENTIONAL FUELS AND ADDITIVES 

Background 

• The term "conventional" refers to gasoline and diesel F/FAs which: 

- Meet EPA's criteria for categorization as "substantially similar" to the 

respective certification fuel (already in effect for gasoline, now under 

development for diesel) 

- Do not contain compounds other than those typically in 1990 gasoline 

or diesel fuels, nor unusual concentrations of such compounds 

• Section 211(e)(3) gives authority to allow program exemptions for F/FAs 

if EPA finds that "additional testing of such fuel or fuel additive would 

be duplicative of adequate existing testing" 

- Existing information on conventional fuels (and their additives) is 

extensive: adequate to justify current and planned mobile source 

regulations 

- Exception: Significant information gap regarding potential teratogenic 

and other reproductive effects of gasoline and diesel emissions 

Planned Approach 

• Exempt conventional F/FAs from all program requirements, assuming 

satisfactory completion of teratology and reproductive studies to be 

specified by EPA 

• Retain authority to require additional testing to address new concerns 

which may arise in the future 

-11-
P.13 

TREATMENT OF CONVENTIONAL FUELS AND ADDITIVES 

(Continued) 

Topics for Discussion 

• Are there additional information gaps in regard to the health effects of 

gasoline and/or diesel fuels which must be filled to provide adequate 

information for regulatory decision-making? 

• Should EPA make a finding which exempts these products from program 

requirements or, alternatively, should the producers of conventional 

F/FAs be required to supply data demonstrating the existence of 

"adequate information"? 

-12-
P.14 

ASSESSMENT OF HEALTH/WELFARE EFFECTS 

Overview of Tier Structure 

Tier 1 

• Emission speciation 

• Literature search for existing information on health and environmental 

testing 

• Data analysis and exposure modeling 

Tier 2 

• Short-term laboratory testing for designated health effects 

• Tier 2 required only to the extent that the results of well-conducted comparable tests are not found during Tier 1 activities 

Tier 3 

• Additional testing at EPA's discretion, based on specific information 

needs indicated by results of Tiers 1 and 2 

-13 -
P.15 

ASSESSMENT OF HEALTH/WELFARE EFFECTS 

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 

Required Speciation Procedures 

• EPA bench procedures for CO, C02, total hydrocarbon, methane, NOx, 

and total particulates (when applicable) 

• Protocols developed by the Auto/Oil Study, including gas chromatography (GC) for C 1-C 12 hydrocarbons and alcohols and HPLC for 

aldehydes 

• Identification of polycyclic aromatic hydrocarbons (PAHs) in both vapor 

phase and particulate phase of exhaust emissions 

• Determination of the chemical fate of elements of special concern, e.g., 

metals, halogens 

• Possible additional compound-specific analyses for designated air toxics 

Special Considerations for Additives 

• To approximate in-use conditions, additives must be mixed with the appropriate parent fuel prior to generation and analysis of emissions 

- Additive concentrations may be "doped up" to enhance detectability 

• To determine additive's contribution to speciated products, the emissions 

profile of the parent fuel must be subtracted from the emissions profile 

of the additive/fuel mixture 

-14-
P.16 

ASSESSMENT OF HEALTH/WELFARE EFFECTS 

Tier 1: Emission Speciation (Continued) 

Topics for Discussion 

• Regarding combustion emissions: 

- What vehicles and operating conditions are appropriate for generating 

the emissions? 

- Are the planned speciation procedures reasonable? Are they adequate? 

- To what extent should mass spectroscopy be required in conjunction 

with gas chromatography? 

• Regarding evaporative emissions: 

- What procedures should be used for generating and speciating 

evaporative emissions? 

- What criteria (e.g., VP or RVP limits) should be established for determining whether evaporative emissions are pertinent for a given F/FA? 

- Can evaporative emissions be accurately predicted based on physical 

and chemical characteristics of the liquid F/FA, as an alternative to 

actual chemical analysis? 

• Regarding additives: 

- Will artifacts be created by "doping up" additive concentrations? 

- What parent fuel specifications should be used? 

- Is side-by-side testing of the parent fuel and the additive/fuel mixture 

required? 

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P.17 

ASSESSMENT OF HEALTH/WELFARE EFFECTS 

Tier 1: Information Search and Analysis 

Components 

• Compare emission products of the F/FA to published lists of air toxics 

• Search public and in-house sources for information about the health and 

welfare effects of the F/FA's emissions 

• Use analytic methods (such as the CARB/Carter scale) to estimate the 

chemical reactivity of emitted compounds and their predicted contribution to atmospheric ozone 

• Use modeling methods (such as the Ingalls/Garbe approach, SAE Technical Paper 820787) to estimate concentrations of the speciated 

emissions in typical exposure scenarios 

Evaluation of Information "Adequacy" 

• If the information gathered above includes the results of tests that are 

comparable to those in Tier 2, then the Tier 2 tests will not be required 

- Such studies must test F/FA emissions. For example, whole aerosolized fuels are not equivalent to evaporative emissions 

• Existing tests must be well documented and must be conducted in accordance with established scientific and technical standards 

• EPA will be final judge of adequacy of existing tests, and will reserve 

authority to require additional testing 

-16 -
P.18 

ASSESSMENT OF HEALTH/WELFARE EFFECTS 

Tier 2: Short-Term Laboratory Testing 

Background 

• Minimum battery of screening tests for the previously designated 

endpoints are listed below 

• Ames battery makes use of particulate extract (when applicable), while 

all other tests involve exposure of animals to whole emissions 

• When testing additives, the effects of emissions generated from the 

additive/fuel mixture are compared to the effects of emissions from the 

parent fuel alone 

Required Tests 

• Carcinogenicity (C) and mutagenicity (M) screens: 

- AMES Reverse Mutation Assay (C and M) 

- Unscheduled DNA Synthesis (C) 

- Bone-Marrow Micronucleus Assay (C) 

- With Chromosomal Aberrations (C) 

- With Sister Chromatid Exchange (M) 

• Teratogenicity screen: 

- Inhalation exposure of female rodents during Days 6-15 of pregnancy 

- Analysis of uterine contents on Day 20 

• Reproductive and pulmonary toxicity screens: 

- 28-day inhalation exposure of male and female rodents 

- Morphologic, histologic, and functional analyses of relevant structures 

-17-
P.19 

ASSESSMENT OF HEALTH/WELFARE EFFECTS 

Tier 2: Short-Term Laboratory Testing (Continued) 

Topics for Discussion 

• Are these Tier 2 requirements adequate? Are they reasonable? 

• Should products with high potential risk of exposure (e.g., fuels and 

some oxygenates) be tested more rigorously at Tier 2 than those with 

relatively low exposure potential? 

- For example, should the routine test requirements for fuels include 

subchronic or even chronic inhalation exposure studies, instead of 

leaving such testing to Tier 3? 

• What vehicles and operating condition should be required in generating 

combusion emissions for testing? 

• Should F/FAs with low vapor pressure be excused from test requirements for evaporative emissions? 

• Should evaporative emissions be subject to the same routine health 

testing requirements as combustion emissions? 

• Into what parent fuel formulations (e.g., industry average or certificationtype fuels) should additives be mixed for testing? 

• Is side-by-side testing of the additive/fuel mixture and the parent fuel 

required? 

• Can testing programs be coordinated between manufacturers of fuels and 

manufacturers of related additives? 

-18 -
P.20 

ASSESSMENT OF HEALTH/WELFARE EFFECTS 

Tier 3: Additional Testing Requirements 

EPA retains authority to require additional testing based on results of 

Tiers 1 and 2 

- Could include subchronic (90 day) and/or chronic (2 year) inhalation 

studies, using animal subjects 

- Would be tailored to specific concerns identified in earlier tiers 

Exercised at EPA's discretion on a case-by-case basis, e.g.: 

- Persuasive quahtative evidence of emissions-based toxicity exists, but 

more definitive information is needed for regulatory decision-making 

- Results of Tier 2 tests are negative (i.e., apparently non-toxic), but 

EPA believes inadequate lab technique interfered with results 

- EPA disagrees about "adequacy" of Tier 1 information 

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P.21 

OVERVIEW OF EVALUATION TIERS 

I 

"Conventional" Gasoline or Diesel 

Fuels and Fuel Additives 

Testing to fill specified 

information gaps 

START 1 

C Non-Xonventional" Fuels 

and Fuel Additives 

d. \ 

££_ 

Emissions Speciation 

Data search and analysis: 

Review of previous testing 

Analysis of chemical reactivity and 

exposure potential 

"Adequate" 

Existing — 

Information 

"Indequate" 

Existing Information 

\ 

Tier 2 

Short-term laboratory testing for 

carcinogenic, mutagenic, teratogenic, 

reproductive and pulmonary effects 

T 

Tier 3: Additional Testing 

Longer term, animal-based testing will be 

prescribed at EPA's discretion, e.g., when 

there is persuasive qualitative evidence of 

emissions-based toxicity, and better risk 

quantification is required 

END 

* "Adequate" implies that the existing information includes the results of tests comparable to 

those required in Tier 2. 

-20-
P.22 

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) rales 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 

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

F/FAs and aftermarket gasoline additives introduced pre-1990 

Planned Approach 

• Develop "sub-sim" rales for diesel and other fuel types 

• 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 

-21-
P.23 

EMISSION CONTROL SYSTEM PROVISIONS 

(Continued) 

Topics for Discussion 

• Is this approach adequate to address concerns about the impact of F/FAs 

on ECS function? 

• In existing aftermarket additives (and other F/FAs which have previously 

been outside the jurisdiction of Section 21 Iff]), are there components 

known to have adverse effects on ECS performance? 

-22-
P.24 

OTHER PROGRAM ISSUES 

-23-
P.25 

GROUPING OF FUELS AND FUEL ADDITIVES 

Objectives 

• Enable manufacturers of chemically similar products, on a voluntary 

basis, to share costs of program compUance 

• Minimize dupUcative efforts and redundant information 

• Ease demand on limited laboratory capacity 

• Decrease volume of material for EPA review and analysis 

Planned Approach 

• EPA wiU develop grouping criteria according to chemical composition 

of raw F/FAs, since composition of emissions not yet known 

- Groups likely to be narrowly defined, based on characteristics such as 

aromatic content, presence of specific metals and halogens, etc. 

- Grouping system wiU be updated as needed to properly accommodate 

variabiUty of future F/FAs 

• Formation, organization, and operation of groups preferably brokered by 

participating manufacturers themselves 

• Within each group, one or more representative F/FAs wiU be selected as 

subjects for required tests 

- Selection of representatives may be done by EPA, or may be done by 

manufacturers under EPA guidelines 

- Test results for representatives will be appUed to all group members 

-24-
P.26 

GROUPING OF FUELS AND FUEL ADDITIVES 

(Continued) 

Topics For Discussion 

• Group definitions and selection criteria for group representatives 

• Quality of data in current F/FA Database 

• Formation and organization of groups 

• Financial factors: 

- Cost sharing mechanisms for groups of existing F/FAs 

- "Buy-in" arrangements for manufacturers seeking first-time registration of products which are similar to individual F/FAs or F/FA groups 

that have akeady satisfied program requirements 

- Length of time such provisions should be in effect 

-25-
P.27 

SMALL BUSINESS PROVISIONS 

Authority 

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

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

Planned Approach 

• EPA does not plan to exercise this authority, in consideration of the 

following factors: 

- Proposed exemption for conventional F/FAs is expected to reduce the 

testing burden for many currently-registered products 

- Opportunity for cost sharing 

- Relatively modest requirements planned through Tier 2 

- Additional, more costly testing is to be required only when significant 

hazard potential has been identified 

-26 -
P.28 

* i 

V 

—~~ 

i 

EPA FUELS/FUEL ADDITIVES 

Charles Gray 

James P. Owens 

Steve Pezda 

Steve Smolowitz 

Jim Caldwell 

Joseph Fernandes 

Chet France 

Judy Gray 

Charles Keller 

Carol Stack 

D.I. Hoke 

Heidi Siegelbaum 

John Shook 

Herbert Bruck 

Helen M. Kutska 

John Sepesi 

John Lingelbach 

Kent Helmer 

Grey Dana 

Andrew K. Kauput 

Allen R. Schaeffer 

William Pepelko 

Judy Graham 

Mark J. Riedy 

Carl Mazza 

Dick Wilson 

David Doniger 

C A . Keller 

J.T. Murray 

Tom Leeper 

Craig Leaseburge 

Glenn W. Passavant 

Chris Kira 

Mary Ellen Levine 

Stanley Durkee 

James Greaves 

Jim Caldwell 

Participant 

May 2, 

A-^o-o7 ic-s-o^ 

RULEMAKING 

List 

1991 

EPA 

BASF Corp. 

MVMA/EMA 

N.R.D.C 

EPA 

EPA 

EPA 

EPA 

Exxon/CMA 

CMA 

Lubrizol Corp. 

EPA 

Chevron/CMA 

NPRA 

NPRA 

API 

EPA 

AIAM 

MVMA/GM 

ATA 

EPA 

EPA/ORD 

Shea & Gould 

EPA/OAR 

EPA 

NRDC 

Exxon 

Oxygenated Fuels 

Ethyl Corp. 

Oxygenated Fuels 

EPA/Ann Arbor 

EPA 

EPA/OGC 

EPA/ORD 

EPA/Ann Arbor 

EPA/Washington D.C. 

Bob Greco 

Bob Feristil 

Myron Price 

James Peeples 

Ronald White 

Anita Ducca 

API 

API/Reg. Net. 

API 

CFDC 

ALA 

API